HUMALOG 100 U/ML Инъекционный раствор
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Инструкция по применению UMALOG
Содержание инструкции
- Humalog 100 units/ml injectable solution in a vial
- Humalog 100 units/ml injectable solution in cartridge
- Humalog Mix25 100 units/ml injectable suspension in a vial
- Humalog Mix25 100 units/ml injectable suspension in cartridge
- Humalog Mix50 100 units/ml injectable suspension in cartridge
- Humalog 100 units/ml KwikPen injectable solution in a prefilled pen
- Humalog Mix25 100 units/ml KwikPen injectable suspension in a prefilled pen
- Humalog Mix50 100 units/ml KwikPen injectable suspension in a prefilled pen
- Humalog 200 units/ml KwikPen injectable solution in a prefilled pen
- Humalog 200 units/ml KwikPen injectable solution in a prefilled pen
- Humalog 100 units/ml Junior KwikPen injectable solution in a prefilled pen
- Humalog 100 units/ml Junior KwikPen injectable solution in a prefilled pen
- Humalog 100 units/ml Tempo Pen injectable solution in a prefilled pen
- Humalog 100 units/ml Tempo Pen injectable solution in a prefilled pen
Humalog 100 units/ml injectable solution in a vial
insulin lispro
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog is and what it is used for
- 2. What you need to know before you use Humalog
- 3. How to use Humalog
- 4. Possible side effects
- 5. How to store Humalog
- 6. Contents of the pack and other information
1. What is Humalog and what is it used for?
Humalog is used for the treatment of diabetes. Humalog acts more quickly than normal human insulin
due to a small modification of the insulin molecule.
Your condition, diabetes, stems from the fact that your pancreas does not produce enough insulin to control blood glucose levels. Humalog replaces the insulin produced by your
body and is used to control glucose in the long term. The medicine acts very
quickly and lasts for a shorter period of time compared to a soluble insulin (from 2 to 5 hours). You should normally inject Humalog within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog and a long-acting insulin. Each type
correct use. Do not change the type of insulin unless prescribed by your doctor. Be very
careful when changing the type of insulin.
The use of Humalog is suitable for both adults and children.
2. What you need to know before using Humalog
DO NOT use Humalog
- If you believe you are experiencing hypoglycemia(low blood sugar). Further instructions on how to manage mild hypoglycemia can be found later in this leaflet (see section 3: If you use more Humalog than you should).
- If you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).
Warnings and precautions
- Always check the packaging and the label on the vial to confirm the name and type of insulin you receive from the pharmacist. Make sure your Humalog packaging matches what your doctor has prescribed.
- If your blood glucose level is well controlled with the insulin therapy you are currentlyreceiving, you may not noticethe warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must
pay close attention to the timing of meals, frequency and intensity of physical exercise.
You should also monitor your blood sugar level frequently by measuring it.
sangue sta scendendo troppo. I segni premonitori sono elencati più avanti in questo foglio. Deve
porre molta attenzione all'orario dei pasti, alla frequenza e all'impegno dell'esercizio fisico.
Deve inoltre tenere sotto controllo il livello di zucchero nel sangue, misurandolo di frequente.
- Some people who switched from animal insulin to human insulin have reported that the warning signs of hypoglycemia were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or diabetes center nurse.
- Have you been ill recently?
- Do you have liver or kidney problems?
- Are you doing more exercise than usual?
- Your insulin needs may change if you drink alcohol.
- Also, inform your doctor, pharmacist or diabetes center nurse if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with long-standing type 2 diabetes and heart disease or a previous cerebrovascular event who were treated with pioglitazone and insulin have reported the development of heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
Changes in the skin at the injection site
The injection site must be rotated to prevent changes in the skin, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject it into
an area with lumps (see section How to use Humalog). If you are currently injecting into
an area with lumps, consult your doctor before starting to inject into another area. Your
doctor may advise you to check your blood sugar more carefully and adjust your insulin dose or
other diabetes medications.
Other medicines and Humalog
Your insulin needs may change if you are taking
- the birth control pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- beta2-agonists (e.g. ritodrine, salbutamol, terbutaline),
- beta-blockers,
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) and
- angiotensin II receptor antagonists.
Tell your doctor if you are taking, have recently taken or may take any other
medicines, including those available without a prescription (see section “Warnings and precautions”).
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase in the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and operating machinery
Your ability to concentrate and react may be impaired if you experience hypoglycemia.
Be aware of this possibility in all situations where you could put yourself or
others at risk (e.g. driving a vehicle or using machinery). You should consult
your doctor about whether it is advisable to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia
Humalog contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
3. How to use Humalog
Always use Humalog exactly as your doctor has instructed you. If you have any doubts, you should consult your
doctor.
Dose
- Normally, you should inject Humalog within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding quantity, timing and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
- Inject Humalog under the skin. You should only have an intramuscular injection following a specific indication from your doctor.
Preparation of Humalog
- Humalog is already dissolved in water, so you do not need to mix it. However, be careful to use it onlyif its appearance is the same as that of water. The solution must be clear, colorless and free of solid particles. Check all of this before each injection.
Injection of Humalog
- First, wash your hands.
- Before making the injection, disinfect the skin according to the instructions you have received. Disinfect the rubber stopper of the vial, but do not remove it.
- Use a sterile syringe and needle to puncture the rubber stopper and draw up the amount of Humalog you need to inject. Your doctor or the diabetes center will show you exactly how to do this. Absolutely avoid sharing syringes and needles with others.
- Inject the medication under the skin, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used previously and remember to rotate the injection site, as you have been told. It does not matter which injection site you use, whether it is the upper arms, thighs, buttocks or abdomen, the injection of Humalog will have an even faster action than soluble human insulin.
- Your doctor will tell you if you need to mix Humalog with one of the human insulins. For example, if you need to inject a mixture, draw up Humalog into the syringe before drawing up the long-acting insulin .Inject the mixture immediately after preparing it. Repeat the same operations exactly every time. Normally you should not mix Humalog with one of the human insulins
already mixed. Never mix Humalog with insulins from other manufacturers or with animal insulins.
- You should not administer Humalog intravenously. Inject Humalog as your doctor or nurse has taught you. Only your doctor can administer Humalog intravenously. He will do this only in particular circumstances such as surgery or if you are ill and your blood sugar levels are too high.
Use of Humalog in an insulin pump
- Only some insulin pumps with CE marking can be used to administer lispro insulin. Before administering lispro insulin, the instructions provided by the manufacturer must be read carefully to establish its suitability or not for that particular pump. Read and follow the instructions in the documentation provided with the pump.
- Make sure to use the appropriate reservoir and catheter for the pump.
- The infusion set (tube and needle) must be changed following the instructions attached to the infusion set.
- In the event of an episode of hypoglycemia, the infusion must be interrupted until the episode is resolved. If you experience repeated or severe episodes of reduced blood sugar levels, inform your doctor and consider the need to reduce or stop the insulin infusion.
- A malfunction of the pump or an obstruction of the infusion set can lead to a rapid increase in blood sugar levels. If you suspect an interruption in the flow of insulin, follow the instructions in the documentation that accompanies the product and, if appropriate, report it to your doctor.
- When used with an insulin pump, Humalog should not be mixed with any other insulin.
If you use more Humalog than you should
If you use more Humalog than you should or are not sure how much you have injected, a
decrease in blood sugar levels may occur. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia), eat glucose tablets, sugar or have a sugary drink. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and your breathing is short and your skin is pale, inform your doctor immediately. A glucagon injection can treat
quite severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you
do not get a positive response with glucagon, you must be hospitalized. Ask your doctor
for information on the use of glucagon.
If you forget to use Humalog
If you take less Humalog than you need or are not sure how much you have injected, an
increase in blood sugar levels may occur. Check your blood sugar level.
Untreated hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar)
can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death (see paragraphs A and B of section 4
“Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always keep some syringes and a vial of Humalog in stock.
- Always carry a document indicating that you are diabetic.
- Always carry some sugar with you.
If you stop treatment with Humalog
If you take less Humalog than you need, an increase in blood sugar levels may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Systemic allergy is rare (from ≥ 1/10,000 to <1/1,000). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
lowering of blood pressure
rapid heartbeat
sweating
If you believe that Humalog is causing you this type of insulin allergy, immediately inform your
doctor.
Local allergy is common (from ≥ 1/100 to <1/10). In some people, the skin at the injection site may
appear red, swollen, and itchy. Usually, this reaction disappears within a few days or weeks. If this occurs, inform your doctor.
Lipodystrophy is uncommon (from ≥ 1/1,000 to <1/100). If you inject insulin too often in the same
place, the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy). Nodules under the
skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis). Insulin may not work as well as it should if you inject it into an area with
nodules. Change the injection site with each injection to prevent these skin changes.
Edema has been reported (e.g., swelling of the arms, ankles; fluid retention), in
particular at the beginning of insulin therapy or during a modification of therapy to improve
blood glucose control.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the
national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.
Common problems of diabetes
- A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog or another insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work performed immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin requirements;
- worsening of pre-existing kidney or liver disease.
Alcohol and certain medications can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
fatigue rapid heartbeat
feeling unwell
cold sweat
If you are unable to recognize the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.
- B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
- failure to take Humalog or another insulin;
- taking a dose of insulin lower than prescribed by your doctor;
- eating a much larger amount of food than allowed by your diet;
- fever, infection, or strong emotion.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling drowsy
facial flushing
thirst
nervousness or agitation
headache
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical
attention.
- C.IllnessIf you become ill, especially if you feel unwell or are sick, your insulin needs may change. Even when you are not eating normally, you still need insulin.Check your urine and blood for sugar; when you are sick, follow the precautions you already know and inform your doctor.
5. How to store Humalog
Before use, store Humalog in a refrigerator (2°C - 8°C). Do not freeze.
During use, store the vial in a refrigerator (2°C - 8°C) or at room temperature (below
30°C) and discard it after 28 days. Do not keep it near a heat source or in direct
sunlight.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The
expiry date refers to the last day of the month.
Do not use this medicine if you notice that it is coloured or contains solid particles. You must use it
onlyif its appearance is the same as water. Check all of this before each injection.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Humalog 100 units/ml injectable solution in a vial contains
- The active ingredient is insulin lispro. Insulin lispro is prepared in the laboratory using a technology called "recombinant DNA". It is a modified form of human insulin, and is therefore different from other insulins of human or animal origin. Insulin lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
- The excipients are m-cresol, glycerol, dibasic sodium phosphate 7H O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH.
Description of Humalog and package contents
Humalog 100 units/ml injectable solution is a sterile, clear and colorless aqueous solution and
contains 100 units of insulin lispro per milliliter (100 units/ml) of injectable solution. Each
vial contains 1,000 units (10 milliliters). Humalog 100 units/ml injectable solution in
vials is available in a pack of 1 vial, 2 vials or in a multiple pack containing 5 packs of 1 vial. Not all pack sizes may
be marketed.
Marketing authorization holder and manufacturer
Humalog 100 units/ml injectable solution in a vial is produced by:
- Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
The marketing authorization is held by Eli Lilly Nederland B.V.,
Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
For further information on this medicinal product, contact the local representative of the marketing
authorization holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/.
Humalog 100 units/ml injectable solution in cartridge
insulin lispro
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog is and what it is used for
- 2. What you need to know before you use Humalog
- 3. How to use Humalog
- 4. Possible side effects
- 5. How to store Humalog
- 6. Contents of the pack and other information
1. What is Humalog and what is it used for
Humalog is used for the treatment of diabetes. Humalog acts more quickly than normal human insulin
due to a small modification of the insulin molecule.
Your condition, diabetes, stems from the fact that your pancreas does not produce enough insulin to control blood glucose levels. Humalog replaces the insulin produced by your
body and is used to control glucose in the long term. The medicine acts very
quickly and lasts for a shorter period of time compared to a soluble insulin (from 2 to 5 hours). You should normally inject Humalog within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog and a long-acting insulin. Each type has a correct use. Do not change the type of insulin unless prescribed by your doctor. Pay close
attention when changing the type of insulin.
The use of Humalog is suitable for both adults and children.
2. What you need to know before using Humalog
DO NOT use Humalog
- If you believe you are experiencing hypoglycemia(low blood sugar). Further in this leaflet are instructions for managing mild hypoglycemia (see section 3: If you use more Humalog than you should).
- If you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).
Warnings and precautions
- Always check the package and cartridge label for the name and type of insulin you receive from the pharmacist. Make sure your Humalog package matches the one prescribed by your doctor.
- If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of meals, frequency and intensity of exercise. You should also monitor your blood sugar level frequently by measuring it.
- Some people who have switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or diabetes center nurse.
- Have you been ill recently?
- Do you have problems with your liver or kidneys?
- Are you doing more exercise than usual?
- Your insulin needs may change if you drink alcohol.
- Also, tell your doctor, pharmacist or diabetes center nurse if you are planning to travel abroad. Time zone differences between countries can lead to a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with long-standing type 2 diabetes and heart disease or a previous cerebrovascular event who have been treated with pioglitazone and insulin have reported the development of heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
Skin changes at the injection site
The injection site must be rotated to prevent skin changes, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject into
an area with lumps (see section How to use Humalog). If you are currently injecting into
an area with lumps, consult your doctor before starting to inject into another area. Your
doctor may advise you to check your blood sugar more carefully and adjust your dose of insulin or
other antidiabetic medicines.
Other medicines and Humalog
Your insulin needs may change if you are taking
- the contraceptive pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- beta2-agonists (e.g. ritodrine, salbutamol, terbutaline),
- beta-blockers,
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) and
- angiotensin II receptor antagonists.
Tell your doctor if you are taking, have recently taken or may take any other
medicines, including those available without a prescription (see section “Warnings and precautions”).
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase in the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and using machines
Your ability to concentrate and react may be reduced if you experience hypoglycemia.
Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using machinery). You should consult
your doctor about whether it is appropriate to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia
Humalog contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially “sodium-free”.
3. How to use Humalog
The 3 ml cartridge must only be used with 3 ml Lilly pens. Do not use with 1.5 ml pens.
Always use Humalog exactly as your doctor has instructed. If you have any doubts, consult your
doctor. To prevent possible transmission of diseases, each cartridge must be used
by a single patient, even if the needle inserted into the delivery device is changed.
Dose
- Normally, you should inject Humalog within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding quantity, timing and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
- Inject Humalog under the skin. You should only make an intramuscular injection following a specific indication from your doctor.
Preparation of Humalog
- Humalog is already dissolved in water, so you do not need to mix it. However, be careful to use it onlyif its appearance is the same as that of water. The solution must be clear, colorless and free of solid particles. Check this before each injection.
Preparation of the pen
- First, wash your hands. Disinfect the rubber membrane of the cartridge.
- You must use Humalog cartridges only with Lilly insulin pens. Make sure the words
pen. The 3 ml cartridge can only be used with the 3 ml pen.
- Follow the instructions included with the pen. Put the cartridge into the pen.
- Set the dose to 1 or 2 units. Then hold the pen with the needle inserted pointing upwards and tap the side of the pen to cause air bubbles to come out. With the pen still pointing upwards, press the injection button until a drop of Humalog comes out of the needle. Some small air bubbles may remain in the pen; they are not dangerous, but if they are too large they may make the dose to be injected less accurate.
Injection of Humalog
- Before making the injection, disinfect the skin according to the instructions you have received. Inject the medicine under the skin, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used last time and remember to rotate the injection site, as you have been told. It does not matter which injection site you use, whether it is the upper arms, thighs, buttocks or abdomen, the injection of Humalog will have an even faster action than soluble human insulin.
- You must not administer Humalog intravenously. Inject Humalog as your doctor or nurse has taught you. Only the doctor can administer Humalog intravenously. He will do this only in specific circumstances such as surgery or if you are ill and your blood sugar levels are too high.
After the injection
- As soon as you have finished the injection, remove the needle from the pen using the outer cap of the needle. This will allow you to keep Humalog sterile, avoid leakage of the medicine, stop air from entering the pen and prevent the needle from becoming clogged. Do not share your needles with others. Do not share your pen with others. Reposition the cap on the pen. Leave the cartridge in the pen.
Subsequent injections
- Before each subsequent injection, select 1 or 2 units and press, activating it, the injection mechanism holding the pen pointing upwards until a drop of Humalog comes out of the needle. You can assess how much Humalog is left in the cartridge by observing its level on the side of it. The distance between each line corresponds to approximately 20 units. If there is not enough left for the next dose, change the cartridge.
Do not mix any other insulin into Humalog cartridge. Once the cartridge is empty, do not
reuse it.
Use of Humalog in an insulin pump
- Only some CE-marked insulin pumps can be used to administer lispro insulin. Before administering lispro insulin, the instructions provided by the manufacturer must be read carefully to establish its suitability for that particular pump. Read and follow the instructions in the documentation provided with the pump.
- Make sure you use the appropriate reservoir and catheter for the pump.
- The infusion set (tube and needle) must be changed following the instructions attached to the infusion set.
- In the event of an episode of hypoglycemia, the infusion must be interrupted until the episode is resolved. If you experience repeated or severe episodes of reduced blood sugar levels, inform your doctor and consider the need to reduce or stop the insulin infusion.
- A malfunction of the insulin pump or an obstruction of the infusion set can lead to a rapid rise in blood sugar levels. If you suspect an interruption in the flow of insulin, follow the instructions in the documentation that accompanies the product and, if appropriate, report it to your doctor.
- When used with an insulin pump, Humalog must not be mixed with any other insulin.
If you use more Humalog than you should
If you use more Humalog than you should or are not sure how much you have injected, you may experience a
decrease in your blood sugar level. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia), eat glucose tablets, sugar or have a sugary drink. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and your breathing is short
and your skin is pale, inform your doctor immediately. A glucagon injection can treat
fairly severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you
do not get a positive response with glucagon, you must be hospitalized. Ask your doctor
for information on the use of glucagon.
If you forget to use Humalog
If you take less Humalog than you need or are not sure how much you have injected, your
blood sugar level may increase. Check your blood sugar level.
Untreated hypoglycemia (low blood sugar level) or hyperglycemia (high blood sugar level)
can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death (see sections A and B of section 4
“Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always keep spare syringes and a vial of Humalog, or a spare pen and cartridges, on hand in case you lose your pen or the cartridges or these are damaged.
- Always carry a document indicating that you are diabetic.
- Always carry sugar with you.
If you stop treatment with Humalog
If you take less Humalog than you need, your blood sugar level may increase.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Systemic allergy is rare (from ≥ 1/10,000 to <1/1,000). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
low blood pressure
fast heartbeat
sweating
If you think Humalog is causing you this type of insulin allergy, tell your doctor immediately.
Local allergy is common (from ≥ 1/100 to <1/10). In some people, the skin at the injection site may
become red, swollen and itchy. Usually, this reaction disappears within a few days or weeks. If this happens, tell your doctor.
Lipodystrophy is uncommon (from ≥ 1/1,000 to <1/100). If you inject insulin too often in the same
place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy). Nodules under the
skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis). Insulin may not work as well as it should if you inject into an area with
nodules. Change the injection site with each injection to prevent these skin changes.
Edema has been reported (e.g. swelling of the arms, ankles; fluid retention), in
particular at the beginning of insulin therapy or during a change in therapy to improve
blood sugar control.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.
Common diabetes problems
- A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog or another insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work performed immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin requirements;
- worsening of pre-existing kidney or liver disorder.
Alcohol and some medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or agitation
headache
fast heartbeat
feeling unwell
cold sweat
If you are unable to recognise the warning symptoms of hypoglycemia avoid situations, such as
driving a car, in which hypoglycemia could put you or others at risk.
- B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
- not taking Humalog or another insulin;
- taking a dose of insulin lower than prescribed by your doctor;
- eating much more food than allowed by your diet;
- fever, infection or a strong emotion.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical
attention.
- C.IllnessIf you have an illness, especially if you feel unwell, your insulin needs may change. Even when you are not eating normally, you still need insulin.Test your urine and blood; when you are ill follow the precautions you already know and tell your doctor.
5. How to store Humalog
Before use, store Humalog in a refrigerator (2°C - 8°C). Do not freeze.
During use, store the cartridge at room temperature (below 30°C) and discard it after 28
days. Do not keep the product near a heat source or in direct sunlight. Do not store the pen or cartridges that you are using in the
refrigerator. The pen containing the cartridge must not be
stored with the needle inserted.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging. The
expiry date refers to the last day of the month.
Do not use this medicine if you notice that it is coloured or contains solid particles. You must use it
onlyif its appearance is the same as water. Check all of this before each injection.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Humalog 100 units/ml solution for injection in a cartridge contains
- The active ingredient is insulin lispro. Insulin lispro is prepared in the laboratory using a technology called "recombinant DNA". It is a modified form of human insulin, and is therefore different from other insulins of human or animal origin. Insulin lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
- The excipients are m-cresol, glycerol, dibasic sodium phosphate 7H O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH.
Description of Humalog and contents of the pack
Humalog 100 units/ml solution for injection is a sterile, clear, colorless aqueous solution and
contains 100 units of insulin lispro per milliliter (100 units/ml) of solution for injection. Each
cartridge contains 300 units (3 milliliters). The cartridges are available in packs of 5 or 10
cartridges. Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Humalog 100 units/ml solution for injection in a cartridge is manufactured by:
- Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.
- Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino (FI), Italy.
The marketing authorization is held by Eli Lilly Nederland B.V.,
Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
For further information on this medicinal product, contact the local representative of the marketing
authorization holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Eli Lilly Nederland" B.V. - Bulgaria
tel. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
PHARMASERV-LILLY A.E.B.E.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
LatvijaUnited Kingdom
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/.
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Humalog Mix25 100 units/ml injectable suspension in a vial
insulin lispro
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog Mix25 is and what it is used for
- 2. What you need to know before you use Humalog Mix25
- 3. How to use Humalog Mix25
- 4. Possible side effects
- 5. How to store Humalog Mix25
- 6. Contents of the pack and other information
1. What is Humalog Mix25 and what is it used for
Humalog Mix25 is used for the therapy of diabetes. Humalog Mix25 is a premixed suspension.
The active ingredient contained in it is insulin lispro. 25% of the insulin lispro
contained in Humalog Mix25 is dissolved in water and acts more quickly than normal human
insulin due to a small modification of the insulin molecule. 75% of the insulin lispro
contained in Humalog Mix25 is present in suspension together with protamine sulfate, so that
its action is prolonged.
Your illness, diabetes, derives from the fact that your pancreas does not produce insulin in
sufficient quantity to control the level of glucose in the blood. Humalog Mix25 replaces the insulin produced
by your body and is used to control glucose in the long term. Humalog Mix25
acts very quickly and for a longer duration compared to soluble insulin. As a rule, you should inject
Humalog Mix25 within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog Mix25 and a long-acting insulin.
its correct use. Do not change the type of insulin unless prescribed by your doctor. Pay close
attention when changing the type of insulin.
2. What you need to know before using Humalog Mix25
DO NOT use Humalog Mix25
- If you believe you are experiencing hypoglycemia(low blood sugar). Further instructions on how to manage mild hypoglycemia can be found later in this leaflet (see section 3: If you use more Humalog Mix25 than you should).
- If you are allergicto insulin lispro or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- Always check the packaging and the label on the vial to ensure you have the name and type of insulin dispensed by the pharmacist. Make sure your Humalog Mix25 packaging matches what your doctor has prescribed.
- If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of meals, the frequency and intensity of exercise. You should also monitor your blood sugar level frequently by measuring it.
- Some people who switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
- Have you been ill recently?
- Do you have problems with your liver or kidneys?
- Are you doing more exercise than usual?
- Your insulin needs may change if you consume alcohol.
- Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with type 2 diabetes diagnosed for a long time and with heart disease or a previous cerebrovascular event who were treated with pioglitazone and insulin have reported the development of heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
Skin changes at the injection site
The injection site must be rotated to prevent skin changes, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject into an
area with lumps (see section How to use Humalog Mix25). If you are currently injecting
into an area with lumps, consult your doctor before starting to inject into another area. Your
doctor may advise you to check your blood sugar more carefully and adjust your insulin dose or
other antidiabetic medicines.
Other medicines and Humalog Mix25
Your insulin needs may change if you are taking
- the contraceptive pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- beta2-agonists (e.g. ritodrine, salbutamol, terbutaline),
- beta-blockers,
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) and
- angiotensin II receptor antagonists.
Tell your doctor if you are taking, have recently taken or may take any other
medicines, including those available without a prescription (see section “Warnings and precautions”).
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase in the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and operating machinery
Your ability to concentrate and react may be impaired if you experience a hypoglycemic reaction.
Be aware of this possibility in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using machinery). You should consult your
doctor about whether it is safe to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia
Humalog Mix25 contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say it is essentially “sodium-free”.
3. How to use Humalog Mix25
Always use Humalog Mix25 exactly as your doctor has instructed. If you have any doubts, you should
consult your doctor.
Dosage
- Normally, you should inject Humalog Mix25 within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding the quantity, timing and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
- Inject Humalog Mix25 under the skin. Do not administer the medication using another route of administration. Under no circumstances should Humalog Mix25 be administered intravenously.
Preparation of Humalog Mix25
- Before use, vials containing Humalog Mix25 must be rotated between the palms of your hands to return the insulin to suspension until it appears uniformly cloudy or milky. Do not shake vigorously, as this may cause foaming which may compromise accurate dose measurement. The vials should be examined frequently and should not be used if floating residues or white particles adhering to the bottom or walls of the vial are observed, which give it a frosted appearance. Check all this before each injection.
Injection of Humalog Mix25
- First, wash your hands.
- Before injecting, disinfect the skin according to the instructions you have received. Disinfect the rubber stopper of the vial, but do not remove it.
- Use a sterile syringe and needle to puncture the rubber stopper and draw up the amount of Humalog Mix25 you need to inject. Your doctor or diabetes center will
tell you exactly how to do it. Absolutely avoid sharing syringes and
needles with others.
- Inject the medication subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the previous one and remember to rotate the injection site, as you have been told.
If you use more Humalog Mix25 than you should
If you use more Humalog Mix25 than you should or are not sure how much you have injected, a
decrease in blood sugar levels may occur. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia),eat glucose tablets, sugar or drink a sugary beverage. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and your breathing becomes short and your skin becomes pale, inform your doctor immediately. A glucagon injection can treat
fairly severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you
do not get a positive response with glucagon, you must be hospitalized. Ask your doctor
for information on the use of glucagon.
If you forget to use Humalog Mix25
If you take less Humalog Mix25 than you need or are not sure how much you have injected, an
increase in blood sugar levels may occur. Check your blood sugar level.
Hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) not treated adequately can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death (see paragraphs A and B of section 4
“Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always keep some syringes and a vial of Humalog Mix25 in stock.
- Always carry a document indicating that you are diabetic.
- Always carry sugar with you.
If you stop treatment with Humalog Mix25
If you take less Humalog Mix25 than you need, an increase in blood sugar levels may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Systemic allergy is rare (from ≥ 1/10,000 to <1/1,000). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
low blood pressure
fast heartbeat
sweating
If you believe that Humalog Mix25 is causing you this type of insulin allergy, inform your
doctor immediately.
Local allergy is common (from ≥ 1/100 to <1/10). In some people, the skin at the injection site may
appear red, swollen, and itchy. Usually, this reaction disappears within a few days or weeks. If this
occurs, inform your doctor.
Lipodystrophy is uncommon (from ≥ 1/1,000 to <1/100). If you inject insulin too often in the same
place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy). Lumps under the
skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis). Insulin may
not work as well as it should if you inject it into an area with lumps. Change the injection site with each
injection to prevent these skin changes.
Edema has been reported (for example, swelling of the arms, ankles; fluid retention),
particularly at the beginning of insulin therapy or during a change in therapy to improve
blood glucose control.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.
Common diabetes problems
- A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog Mix25 or another insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work done immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin requirements;
- worsening of pre-existing kidney or liver problems.
Alcohol and some medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or agitation
headache
fast heartbeat
feeling unwell
cold sweat
If you are unable to recognise the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.
- B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
- not taking Humalog or another insulin;
- taking a dose of insulin lower than prescribed by your doctor;
- eating a much larger amount of food than allowed by your diet;
- fever, infection, or severe emotional stress.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
loss of appetite
breath smelling of fruit
thirst feeling or being sick
Heavy, rapid breathing and fast heartbeat are serious symptoms. Seek immediate medical
attention.
- C.IllnessIf you have an illness, especially if you feel unwell, your insulin needs may change. Even when you are not eating normally, you still need insulin.Test your urine and blood; when you are ill follow the precautions you already know and inform your doctor.
5. How to store Humalog Mix25
Before use, store Humalog Mix25 in a refrigerator (2°C - 8°C). Do not freeze.
During use, store the vial in a refrigerator (2°C - 8°C) or at room temperature (below
30°C) and discard it after 28 days. Do not keep it near a heat source or in direct
sunlight.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label and on the packaging. The
expiry date refers to the last day of the month.
Do not use this medicine if you notice the presence of floating residues or white particles adhering to the
bottom or walls of the vial, which give it a frosted appearance. Check all
this before each injection.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Humalog Mix25 100 units/ml injectable suspension in a vial contains
- The active ingredient is insulin lispro. Insulin lispro is prepared in the laboratory using a technology called "recombinant DNA". It is a modified form of human insulin, and is therefore different from other insulins of human or animal origin. Insulin lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
- The excipients are protamine sulfate, m-cresol, phenol, glycerol, disodium phosphate heptahydrate, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been added to adjust the pH.
Description of the appearance of Humalog Mix25 100 units/ml injectable suspension in a vial and
contents of the pack
Humalog Mix25 100 units/ml injectable suspension is a sterile white suspension and contains
100 units of insulin lispro per millilitre (100 units/ml) of injectable suspension. 25%
of the insulin lispro contained in Humalog Mix25 is dissolved in water. 75% of the insulin lispro
contained in Humalog Mix25 is present in suspension together with protamine sulfate. Each
vial contains 1,000 units (10 millilitres). Humalog Mix25 100 units/ml injectable suspension in
a vial is available in a pack of 1 vial.
Marketing authorisation holder and manufacturer
Humalog Mix25 100 units/ml injectable suspension in a vial is manufactured by:
- Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
The marketing authorisation is held by Eli Lilly Nederland B.V.,
Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/.
Humalog Mix25 100 units/ml injectable suspension in cartridge
insulin lispro
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog Mix25 is and what it is used for
- 2. What you need to know before you use Humalog Mix25
- 3. How to use Humalog Mix25
- 4. Possible side effects
- 5. How to store Humalog Mix25
- 6. Contents of the pack and other information
1. What is Humalog Mix25 and what it is used for
Humalog Mix25 is used for the therapy of diabetes. Humalog Mix25 is a premixed suspension.
The active ingredient contained in it is insulin lispro. 25% of the insulin lispro
contained in Humalog Mix25 is dissolved in water and acts more quickly than normal human insulin
thanks to a small modification of the insulin molecule. 75% of the insulin lispro
contained in Humalog Mix25 is present in suspension together with protamine sulfate, so that
its action is prolonged.
Your illness, diabetes, derives from the fact that your pancreas does not produce insulin in sufficient
quantity to control the level of glucose in the blood. Humalog Mix25 replaces the insulin produced
by your body and is used to control glucose in the long term. Humalog Mix25
acts very quickly and for a longer time compared to soluble insulin. As a rule, you should inject
Humalog Mix25 within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog Mix25 and a long-acting insulin.
its correct use. Do not change the type of insulin unless prescribed by your doctor. Be very
careful when changing the type of insulin.
2. What you need to know before using Humalog Mix25
DO NOT use Humalog Mix25
- If you believe you are experiencing hypoglycemia(low blood sugar). Further instructions on how to manage mild hypoglycemia can be found later in this leaflet (see section 3: If you use more Humalog Mix25 than you should).
- If you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).
Warnings and precautions
- Always check the packaging and cartridge label for the name and type of insulin you receive from the pharmacist. Make sure your Humalog Mix25 packaging matches what your doctor has prescribed.
- If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You should pay close attention to the timing of your meals, the frequency and intensity of exercise. You should also monitor your blood sugar level frequently by measuring it.
- Some people who have switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you experience hypoglycemia frequently, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
- Have you been ill recently?
- Do you have liver or kidney problems?
- Are you doing more exercise than usual?
- Your insulin needs may change if you drink alcohol.
- Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with long-standing type 2 diabetes and heart disease or a previous cerebrovascular event who have been treated with pioglitazone and insulin have reported the development of heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
Skin changes at the injection site
The injection site must be rotated to prevent skin changes, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject into
an area with lumps (see section How to use Humalog Mix25). If you are currently injecting
into an area with lumps, consult your doctor before starting to inject into another area. The
doctor may advise you to check your blood sugar more carefully and adjust your dose of insulin or
other antidiabetic medications.
Other medicines and Humalog Mix25
Your insulin needs may change if you are taking
- the birth control pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- beta2-agonists (e.g. ritodrine, salbutamol, terbutaline),
- beta-blockers,
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) and
- angiotensin II receptor antagonists.
Tell your doctor if you are taking, have recently taken, or may take any other
medicines, even those available without a prescription (see section “Warnings and precautions”).
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase in the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and using machines
Your ability to concentrate and react may be reduced if you experience a hypoglycemic reaction.
Be aware of this possibility in all situations where you could put yourself or
others at risk (e.g. driving a vehicle or using machinery). You should consult
your doctor about whether it is advisable to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia
Humalog Mix25 contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
3. How to use Humalog Mix25
The 3 ml cartridge must only be used with 3 ml Lilly pens. Do not use with 1.5 ml pens.
Always use Humalog Mix25 exactly as your doctor has instructed you. If you have any doubts, consult your doctor. To prevent possible transmission of diseases, each cartridge must be used by only one patient, even if the needle inserted into the delivery device is changed.
Dose
- Normally, you should inject Humalog Mix25 within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding the quantity, timing, and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
- Inject Humalog Mix25 under the skin. Do not administer the medication using another route of administration. Under no circumstances should Humalog Mix25 be administered intravenously.
Preparation of Humalog Mix25
- Immediately before use, the cartridges containing Humalog Mix25 must be rotated ten times between the palms of your hands and inverted 180° ten times to return the insulin to suspension until it appears uniformly cloudy or milky. If this does not happen, repeat the above procedure until the components are mixed. The cartridges are equipped with a small glass ball that facilitates mixing. Do not shake vigorously, as this maneuver may cause foam to form, which may compromise the correct measurement of the dose. The cartridges should be examined frequently and should not be used if floating residue or white particles adhering to the bottom or walls of the cartridge are observed, giving it an icy appearance. Check all of this before each injection.
Preparation of the pen
- First, wash your hands. Disinfect the rubber membrane of the cartridge.
- You must use Humalog Mix25 cartridges only with Lilly insulin pens. Make sure the words
pen. The 3 ml cartridge can only be used with the 3 ml pen.
- Follow the instructions enclosed with the pen. Put the cartridge into the pen.
- Set the dose to 1 or 2 units. Then hold the pen with the needle inserted pointing upwards and tap the side of the pen to dislodge any air bubbles. With the pen still pointing upwards, press the injection button until a drop of Humalog Mix25 comes out of the needle. Some small air bubbles may remain in the pen; they are not dangerous, but if they are too large they may make the dose to be injected less accurate.
Injection of Humalog Mix25
- Before making the injection, disinfect the skin according to the instructions you have received. Inject the medication subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the previous one and remember to rotate the injection site, as you have been told.
After the injection
- As soon as you have finished the injection, remove the needle from the pen using the outer cap of the needle. This will allow you to keep Humalog Mix25 sterile, prevent leakage of the medication, stop air from entering the pen, and prevent the needle from becoming clogged. Do not share your needles with others. Do not share your pen with others. Reposition the cap on the pen. Leave the cartridge in the pen.
Subsequent injections
- Before each subsequent injection, select 1 or 2 units and press, activating it, the injection mechanism holding the pen pointing upwards until a drop of Humalog Mix25 comes out of the needle. You can assess how much Humalog is left in the cartridge by observing its level on the side of it. The distance between each line corresponds to approximately 20 units. If there is not enough left for the next dose, change the cartridge.
Do not mix any other insulin into Humalog Mix25 cartridge. Once the cartridge is
empty, do not reuse it.
If you use more Humalog Mix25 than you should
If you use more Humalog Mix25 than you should or are not sure how much you have injected, a
decrease in blood sugar levels may occur. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia), eat glucose tablets,
sugar or take a sugary drink. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and your breathing is short
and your skin turns pale, inform your doctor immediately. A glucagon injection can treat
fairly severe hypoglycemias. Take glucose or sugar after the glucagon injection. If you
do not get a positive response with glucagon, you must be hospitalized. Ask your doctor
for information on the use of glucagon.
If you forget to use Humalog Mix25
If you take less Humalog Mix25 than you need or are not sure how much you have injected, a
increase in blood sugar levels may occur. Check your blood sugar level.
Hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) not treated adequately can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death (see paragraphs A and B of section 4
“Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always keep some syringes and a vial of Humalog Mix25, or a spare pen and cartridges, on hand in case you lose your pen or the cartridges or if these are damaged.
- Always carry a document indicating that you are diabetic.
- Always carry sugar with you.
If you stop treatment with Humalog Mix25
If you take less Humalog Mix25 than you need, an increase in blood sugar levels may occur. Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Systemic allergy is rare (from ≥ 1/10,000 to <1/1,000). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
low blood pressure
fast heartbeat
sweating
If you believe that Humalog Mix25 is causing you this type of allergy to insulin, inform your
doctor immediately.
Local allergy is common (from ≥ 1/100 to <1/10). In some people, the skin at the injection site may
appear red, swollen and itchy. Usually, this reaction disappears within a few days or weeks. If this
occurs, inform your doctor.
Lipodystrophy is uncommon (from ≥ 1/1,000 to <1/100). If you inject insulin too often in the same
place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy). Lumps under the
skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis). Insulin
may not work as well as it should if you inject into an area with lumps. Change the injection site with
each injection to prevent these skin changes.
Edema has been reported (for example, swelling of the arms, ankles; fluid retention),
particularly at the beginning of insulin therapy or during a change in therapy to improve
blood sugar control.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through
By reporting side effects you can help provide more information on the safety
of this medicine.
Common problems of diabetes
- A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog Mix25 or other insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work performed immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin requirements;
- worsening of pre-existing kidney or liver problems.
Alcohol and some medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or agitation
headache
fast heartbeat
feeling unwell
cold sweat
If you are unable to recognise the warning symptoms of hypoglycemia avoid situations, such as
driving a vehicle, in which hypoglycemia could put you or others at risk.
- B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
- not taking Humalog or other insulin;
- taking a dose of insulin lower than that prescribed by your doctor;
- eating a much larger amount of food than allowed by your diet;
- fever, infection or strong emotion.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical
attention.
- C.IllnessIf you have an illness, especially if you feel unwell or are sick, your insulin needs may change. Even when you are not eating normally, you still need insulin.Test your urine and blood; when you are ill follow the precautions you already know and inform your doctor.
5. How to store Humalog Mix25
Before use, store Humalog Mix25 in a refrigerator (2°C - 8°C). Do not freeze.
During use, store the cartridge at room temperature (below 30°C) and discard it after 28
days. Do not keep the product near a heat source or in direct sunlight. Do not store the pen or cartridges you are using in
the refrigerator. The pen containing the cartridge must not be
stored with the needle inserted.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The
expiry date refers to the last day of the month.
Do not use this medicine if you notice the presence of floating residues or white particles adhering to the
bottom or walls of the cartridge, which give it a frosted appearance. Check all
this before each injection.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Humalog Mix25 100 units/ml injectable suspension in cartridge contains
- The active ingredient is insulin lispro. Insulin lispro is prepared in the laboratory using a technology called "recombinant DNA". It is a modified form of human insulin, and is therefore different from other insulins of human or animal origin. Insulin lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
- The excipients are protamine sulfate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been added to adjust the pH.
Description of the appearance of Humalog Mix25 100 units/ml injectable suspension in cartridge and
package contents
Humalog Mix25 100 units/ml injectable suspension is a sterile white suspension and contains
100 units of insulin lispro per millilitre (100 units/ml) of injectable suspension. 25%
of the insulin lispro contained in Humalog Mix25 is dissolved in water. 75% of the insulin lispro
contained in Humalog Mix25 is present in suspension together with protamine sulfate. Each cartridge
contains 300 units (3 millilitres). The cartridges are available in a pack of 5 or 10 cartridges. Not
all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Humalog Mix25 100 units/ml injectable suspension in cartridge is manufactured by:
- Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.
- Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI), Italy.
The marketing authorisation is held by Eli Lilly Nederland B.V.,
Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Nederland
Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/
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Humalog Mix50 100 units/ml injectable suspension in cartridge
insulin lispro
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Humalog Mix50 is and what it is used for
- 2. What you need to know before you use Humalog Mix50
- 3. How to use Humalog Mix50
- 4. Possible side effects
- 5. How to store Humalog Mix50
- 6. Contents of the pack and other information
1. What is Humalog Mix50 and what it is used for
Humalog Mix50 is used for the therapy of diabetes. Humalog Mix50 is a premixed suspension.
The active ingredient contained in it is insulin lispro. 50% of the insulin lispro
contained in Humalog Mix50 is dissolved in water and acts more quickly than normal human
insulin due to a small modification of the insulin molecule. 50% of the insulin lispro
contained in Humalog Mix50 is present in suspension together with protamine sulfate, so that
its action is prolonged.
Your illness, diabetes, stems from the fact that your pancreas does not produce insulin in
sufficient quantity to control blood glucose levels. Humalog Mix50 replaces the insulin produced
by your body and is used to control glucose in the long term. Humalog Mix50
acts very quickly and for a longer duration compared to soluble insulin. As a rule, you should inject
Humalog Mix50 within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog Mix50 and a long-acting insulin.
its correct use. Do not change the type of insulin unless prescribed by your doctor. Be very
careful when changing the type of insulin.
2. What you need to know before using Humalog Mix50
DO NOT use Humalog Mix50
- If you believe you are experiencing hypoglycemia(low blood sugar). Further instructions on how to manage mild hypoglycemia can be found later in this leaflet (see section 3: If you use more Humalog Mix50 than you should).
- If you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).
Warnings and precautions
- Always check the packaging and the cartridge label for the name and type of insulin you receive from the pharmacist. Make sure your Humalog Mix50 pack corresponds to the one prescribed by your doctor.
- If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of meals, frequency and intensity of physical exercise. You should also monitor your blood sugar level frequently by measuring it.
- Some people who have switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
- Have you been ill recently?
- Do you have problems with your liver or kidneys?
- Are you doing more exercise than usual?
- Your insulin needs may change if you drink alcohol.
- Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries can lead to a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with type 2 diabetes diagnosed for a long time and with heart disease or a previous cerebrovascular event who have been treated with pioglitazone and insulin have reported the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
Changes in the skin at the injection site
The injection site must be rotated to prevent changes in the skin, such as the appearance of
nodules under the skin. Insulin may not work as well as it should if you inject it into
an area with nodules (see section How to use Humalog Mix50). If you are currently injecting
into an area with nodules, consult your doctor before starting to inject into another area. The
doctor may advise you to check your blood sugar more carefully and adjust the dose of insulin or
other antidiabetic medicines.
Other medicines and Humalog Mix50
Your insulin needs may change if you are taking
- the contraceptive pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- beta2-agonists (e.g. ritodrine, salbutamol, terbutaline),
- beta-blockers,
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) and
- angiotensin II receptor antagonists.
Tell your doctor if you are taking, have recently taken or may take any other
medicines, even those available without a prescription (see section “Warnings and precautions”).
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase in the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and operating machinery
Your ability to concentrate and react may be reduced if you experience a hypoglycemic reaction.
Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using machinery). You should consult
your doctor about whether it is advisable to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia HumalogMix50 contains sodiumThis medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially “sodium-free”.
3. How to use Humalog Mix50
The 3 ml cartridge must only be used with 3 ml Lilly pens. Do not use with 1.5 ml pens.
Always use Humalog Mix50 exactly as your doctor has instructed. If you have any doubts, consult your doctor. To prevent possible transmission of diseases, each cartridge must be used by only one patient, even if the needle inserted into the delivery device is changed.
Dose
- Normally, you should inject Humalog Mix50 within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding the amount, timing, and frequency of administration, follow your doctor's instructions exactly: they apply only to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or it may be carried out gradually over a period of weeks or months.
- Inject Humalog Mix50 under the skin. Do not administer the medication using another route of administration. Under no circumstances should Humalog Mix50 be administered intravenously.
Preparation of Humalog Mix50
- Immediately before use, the cartridges containing Humalog Mix50 must be rotated ten times between the palms of your hands and inverted 180° ten times to return the insulin to suspension until it appears uniformly cloudy or milky. If this does not happen, repeat the above procedure until the components are mixed. The cartridges are equipped with a small glass ball that facilitates mixing. Do not shake vigorously, as this maneuver may cause foam formation that may compromise the correct measurement of the dose. The cartridges should be examined frequently and should not be used if floating residue or white particles adhering to the bottom or walls of the cartridge are observed, giving it an icy appearance. Check all of this before each injection.
Preparation of the pen
- First, wash your hands. Disinfect the rubber membrane of the cartridge.
- You must use Humalog Mix50 cartridges only with Lilly insulin pens. Make sure the words
pen. The 3 ml cartridge can only be used with the 3 ml pen.
- Follow the instructions enclosed with the pen. Put the cartridge into the pen.
- Set the dose to 1 or 2 units. Then hold the pen with the needle inserted pointing upwards and tap the side of the pen to dislodge any air bubbles. With the pen still pointing upwards, press the injection button until a drop of Humalog Mix50 comes out of the needle. Some small air bubbles may remain in the pen; they are not dangerous, but if they are too large they may make the dose to be injected less accurate.
Injection of Humalog Mix50
- Before giving the injection, disinfect the skin according to the instructions you have received. Inject the medication under the skin, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used last time and remember to rotate the injection site, as you have been told.
After the injection
- As soon as you have finished the injection, remove the needle from the pen using the outer cap of the needle. This will allow you to keep Humalog Mix50 sterile, prevent leakage of the medication, stop air from entering the pen, and prevent the needle from becoming clogged. Do not share your needles with others. Do not share your pen with others. Reposition the cap on the pen. Leave the cartridge in the pen.
Subsequent injections
- Before each subsequent injection, select 1 or 2 units and press, activating it, the injection mechanism holding the pen pointing upwards until a drop of Humalog Mix50 comes out of the needle. You can assess how much Humalog is left in the cartridge by observing the level on the side of it. The distance between each line corresponds to approximately 20 units. If there is not enough left for the next dose, change the cartridge.
Do not mix any other insulin into Humalog Mix50 cartridge. Once the cartridge is
empty, do not reuse it.
If you use more Humalog Mix50 than you should
If you use more Humalog Mix50 than you should or are not sure how much you have injected, a
decrease in blood sugar levels may occur. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia),eat glucose tablets,
sugar or take a sugary drink. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and are short of breath
and your skin turns pale, inform your doctor immediately. A glucagon injection can treat
quite severe hypoglycemias. Take glucose or sugar after the glucagon injection. If you do not
get a positive response with glucagon, you must be hospitalized. Ask your doctor
about the use of glucagon.
If you forget to use Humalog Mix50
If you take less Humalog Mix50 than you need or are not sure how much you have injected, a
increase in blood sugar levels may occur. Check your blood sugar level.
Untreated hypoglycemias (low blood sugar levels) or hyperglycemias (high blood sugar levels)
can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death (see paragraphs A and B of section 4
“Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always keep a spare pen and cartridges, in case you lose your pen or the cartridges or if they are damaged.
- Always carry a document indicating that you are diabetic.
- Always carry sugar with you.
If you stop treatment with Humalog Mix50
If you take less Humalog Mix50 than you need, an increase in blood sugar levels may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Systemic allergy is rare (from ≥ 1/10,000 to <1/1,000). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
low blood pressure
fast heartbeat
sweating
If you believe that Humalog Mix50 is causing you this type of allergy to insulin, inform your
doctor immediately.
Local allergy is common (from ≥ 1/100 to <1/10). In some people, the skin at the injection site may
appear red, swollen and itchy. Usually, this reaction disappears within a few days or weeks. If this
occurs, inform your doctor.
Lipodystrophy is uncommon (from ≥ 1/1,000 to <1/100). If you inject insulin too often in the same
place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy). Nodules under
the skin can also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis).
Insulin may not work as well as it should if you inject it into an area with nodules. Change the injection
site with each injection to prevent these skin changes.
Edema has been reported (e.g. swelling of the arms, ankles; fluid retention), in
particular at the beginning of insulin therapy or during a modification of therapy to improve
blood glucose control.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system indicated in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.
Common problems of diabetes
- A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog Mix50 or another insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work performed immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin requirements;
- worsening of pre-existing kidney or liver disease.
Alcohol and some medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or restlessness
headache
fast heartbeat
feeling unwell
cold sweat
If you are unable to recognise the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.
- B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
- failure to take Humalog or another insulin;
- taking a dose of insulin lower than prescribed by your doctor;
- eating a much larger amount of food than allowed by your diet;
- fever, infection or severe emotional stress.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy, rapid breathing and fast pulse are serious symptoms. Seek immediate medical
attention.
- C.IllnessIf you have an illness, especially if you feel unwell or are sick, your insulin needs may change. Even when you are not eating normally, you still need insulin.Test your urine and blood; when you are ill, follow the precautions you already know and inform your doctor.
5. How to store Humalog Mix50
Before use, store Humalog Mix50 in a refrigerator (2°C - 8°C). Do not freeze.
During use, store the cartridge at room temperature (below 30°C) and discard it after 28
days. Do not keep the product near a heat source or in direct sunlight. Do not store in
the refrigerator the pen or the cartridges that you are using. The pen containing the cartridge must not be
stored with the needle inserted.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The
expiry date refers to the last day of the month.
Do not use this medicine if there are floating residues or white particles adhering to the bottom or
walls of the cartridge, which give it a frosted appearance. Check all of this before
each injection.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Humalog Mix50 100 units/ml suspension for injection in a cartridge contains
- The active ingredient is insulin lispro. Insulin lispro is prepared in the laboratory using a technology called "recombinant DNA". It is a modified form of human insulin, and is therefore different from other insulins of human or animal origin. Insulin lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
- The excipients are protamine sulfate, m-cresol, phenol, glycerol, disodium phosphate 7H O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been added to adjust the pH.
Description of the appearance of Humalog Mix50 100 units/ml suspension for injection in a cartridge and
contents of the pack
Humalog Mix50 100 units/ml suspension for injection is a sterile white suspension and contains
100 units of insulin lispro per millilitre (100 units/ml) of suspension for injection. 50%
of the insulin lispro contained in Humalog Mix50 is dissolved in water. 50% of the insulin lispro
contained in Humalog Mix50 is present in suspension together with protamine sulfate. Each cartridge
contains 300 units (3 millilitres). The cartridges are available in a pack of 5 or 10 cartridges.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Humalog Mix50 100 units/ml suspension for injection in a cartridge is manufactured by:
- Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.
- Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI), Italy.
The marketing authorisation is held by Eli Lilly Nederland B.V.,
Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
For further information on this medicine, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Eli Lilly Nederland" BV - Bulgaria
tel. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Nederland
Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
PHARMASERV-LILLY A.E.B.E.
Tel: +30 210 629 4600
Österreich
Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Humalog 100 units/ml KwikPen injectable solution in a prefilled pen
insulin lispro
Each KwikPen delivers from 1 to 60 units in 1-unit increments.
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog KwikPen is and what it is used for
- 2. What you need to know before you use Humalog KwikPen
- 3. How to use Humalog KwikPen
- 4. Possible side effects
- 5. How to store Humalog KwikPen
- 6. Contents of the pack and other information
1. What is Humalog KwikPen and what is it used for
Humalog KwikPen is used for the therapy of diabetes. It acts more quickly than normal human insulin, thanks to a small modification of the insulin molecule.
Your condition, diabetes, stems from the fact that your pancreas does not produce enough insulin to control blood glucose levels. Humalog replaces the insulin produced by your body and is used to control glucose in the long term. The medicine acts very
quickly and lasts for a shorter period of time compared to a soluble insulin (from 2 to 5 hours). Normally you should inject Humalog within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog KwikPen and a long-acting insulin.
its correct use. Do not change the type of insulin unless prescribed by your doctor. Be very
careful when changing the type of insulin.
The use of Humalog is suitable for both adults and children.
The KwikPen is a disposable prefilled pen device containing 3 ml (300 units, 100 units/ml)
of lispro insulin. One KwikPen contains multiple doses of insulin. The KwikPen allows you to
select 1 unit at a time. The number of units is visible in the dosage window, always check it
before the injection.You can administer from 1 to 60 units in a single injection. If the dose
is higher than 60 units, you will need to administer more than one injection.
2. What you need to know before using Humalog KwikPen
DO NOT use Humalog KwikPen
- If you believe you are experiencing hypoglycemia(low blood sugar). Further instructions on how to manage mild hypoglycemia can be found later in this leaflet (see section 3: If you use more Humalog than you should).
- If you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).
Warnings and precautions
- Always check the packaging and label of the prefilled pen to ensure the name and type of insulin you receive from the pharmacist are correct. Make sure your Humalog KwikPen packaging matches what your doctor has prescribed.
- If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of meals, the frequency and intensity of exercise. You should also monitor your blood sugar level frequently by measuring it.
- Some people who switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you experience hypoglycemia frequently, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
- Have you been ill recently?
- Do you have problems with your liver or kidneys?
- Are you doing more exercise than usual?
- Your insulin needs may change if you drink alcohol.
- Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries can lead to a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with type 2 diabetes diagnosed for a long time and with heart disease or a previous cerebrovascular event who were treated with pioglitazone and insulin have reported the development of heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema). This Pen should not be used by the visually impaired or those with visual difficulties without the assistance of a person trained to use the Pen.
Changes to the skin at the injection site
The injection site must be rotated to prevent changes to the skin, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject into
an area with lumps (see section How to use Humalog KwikPen). If you are currently injecting
into an area with lumps, consult your doctor before starting to inject into
another area. Your doctor may advise you to check your blood glucose more carefully and adjust your
dose of insulin or other antidiabetic medicines.
Other medicines and Humalog KwikPen
Your insulin needs may change if you are taking
- the birth control pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- beta2-agonists (e.g. ritodrine, salbutamol, terbutaline),
- beta-blockers,
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) and
- angiotensin II receptor antagonists.
Tell your doctor if you are taking, have recently taken or may take any other
medicines, including those available without a prescription (see section “Warnings and precautions”).
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase in the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and operating machinery
Your ability to concentrate and react may be reduced if you experience a hypoglycemic reaction.
Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using machinery). You should consult
your doctor about whether it is safe to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia HumalogKwikPen contains sodiumThis medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
3. How to use Humalog KwikPen
Always use Humalog KwikPen exactly as your doctor has instructed. If you have any doubts, you should
consult your doctor. To prevent possible transmission of diseases, each pen should be
used by only one patient, even if the needle is changed.
Dose
- Normally, you should inject Humalog within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding quantity, timing and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
- Humalog KwikPen is only suitable for subcutaneous injections. Talk to your doctor if you need to inject insulin by another method.
Preparation of Humalog KwikPen
- Humalog is already dissolved in water, so you do not need to mix it. However, be careful to use it onlyif its appearance is the same as that of water. The solution must be clear, colorless and free of solid particles. Check all of this before each injection.
Preparing the KwikPen to make it ready for use (consult the instruction manual for
use)
- First, wash your hands.
- Read the instructions on how to use your prefilled insulin pen and follow them carefully. Some important points are listed below.
- Always use a new needle (needles are not included in the package).
- Prime the KwikPen each time before use. This allows you to check that insulin is flowing out and to eliminate any air bubbles from the KwikPen. Some small air bubbles may have remained in the pen; they are not dangerous, but if they are too large, they could make the dose to be injected less accurate.
Injecting Humalog
- Before making the injection, disinfect the skin according to the instructions you have received. Inject the medication subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used previously and remember to rotate the injection site, as you have been told. It does not matter which injection site you use, whether it is the upper arms, thighs, buttocks or abdomen, the injection of Humalog will have an even faster action than soluble human insulin.
- You should not administer Humalog intravenously. Inject Humalog as your doctor or nurse has taught you. Only the doctor can administer Humalog intravenously. This will only be done in particular circumstances such as surgery or if you are ill and your blood sugar levels are too high.
After the injection
- As soon as you have finished the injection, remove the needle from the KwikPen using the outer needle cap. This will allow you to keep the insulin sterile, prevent leakage of the medication, stop air from entering the pen and prevent the needle from becoming blocked. Do not share your needles with others. Do not share your pen with others. Reposition the cap on the pen.
Subsequent injections
- Each time you use a KwikPen you must use a new needle. Before each injection, eliminate any air bubbles. You can check how much insulin is left in the pen by holding the KwikPen vertically, with the needle pointing upwards. The graduation on the cartridge will indicate approximately the remaining units.
- Do not mix other insulins into your disposable pen. Once the KwikPen is empty, do not reuse it. Dispose of it carefully. Your pharmacist, or the staff at the diabetes center will tell you how to do this.
Use of Humalog in microinfusors
- The KwikPen is only suitable for injections made under the skin. Do not use the pen to administer Humalog in a different way. If this is necessary, other formulations of Humalog 100 units/ml are available. Talk to your doctor if this concerns you.
If you use more Humalog than you should
If you use more Humalog than you should or are not sure how much you have injected, a
decrease in blood sugar level may occur. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia), eat glucose tablets, sugar or drink a sugary beverage. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and your breathing is short
and your skin turns pale, inform your doctor immediately. A glucagon injection can treat
fairly severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you
do not get a positive response with glucagon, you must be hospitalized. Ask your doctor
for information on the use of glucagon.
If you forget to use Humalog
If you take less Humalog than you need or are not sure how much you have injected, an
increase in blood sugar level may occur. Check your blood sugar level.
Untreated hypoglycemia (low blood sugar level) or hyperglycemia (high blood sugar level)
can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death (see paragraphs A and B of section 4
“Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always keep some syringes and a vial of Humalog, or a spare pen and cartridges, in stock in case you lose the KwikPen or it is damaged.
- Always carry a document indicating that you are diabetic.
- Always carry some sugar with you.
If you stop treatment with Humalog
If you take less Humalog than you need, a rise in blood sugar level may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about using this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Systemic allergy is rare (from ≥ 1/10,000 to <1/1,000). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
low blood pressure
fast heartbeat
sweating
If you think that Humalog is causing you this type of insulin allergy, tell your doctor immediately.
Local allergy is common (from ≥ 1/100 to <1/10). In some people, the skin at the injection site may
become red, swollen and itchy. Usually, this reaction disappears within a few days or weeks. If this
occurs, tell your doctor.
Lipodystrophy is uncommon (from ≥ 1/1,000 to <1/100). If you inject insulin too often in the same
place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy). Lumps under the
skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis). Insulin
may not work as well as it should if you inject it into an area with lumps. Change the injection site with
each injection to prevent these skin changes.
Edema has been reported (e.g. swelling of the arms, ankles; fluid retention),
particularly at the beginning of insulin therapy or during a change in therapy to improve
blood glucose control.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.
Common problems of diabetes
- A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog or another insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work done immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin requirements;
- worsening of pre-existing kidney or liver disorder.
Alcohol and some medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or agitation
headache
fast heartbeat
feeling unwell
cold sweat
If you are unable to recognise the warning symptoms of hypoglycemia avoid situations, such as
driving a vehicle, in which hypoglycemia could put you or others at risk.
- B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
- not taking Humalog or another insulin;
- taking a dose of insulin lower than that prescribed by your doctor;
- eating a much larger amount of food than allowed by your diet;
- fever, infection or strong emotion.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy, rapid breathing and fast pulse are serious symptoms. Seek immediate medical attention.
- C.IllnessIf you have an illness, especially if you feel unwell or are sick, your insulin needs may change. Even when you are not eating normally, you still need insulin.Test your urine and blood; when you are ill follow the precautions you already know and tell your doctor.
5. How to store Humalog KwikPen
Before use, store Humalog KwikPen in a refrigerator (2°C - 8°C). Do not freeze.
During use, store Humalog KwikPen at room temperature (below 30°C) and discard it
after 28 days. Do not keep the product near a heat source or in direct sunlight. Do not
store the KwikPen you are using in the refrigerator. The KwikPen should not be stored with the
needle inserted.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The
expiry date refers to the last day of the month.
Do not use this medicine if the solution appears colored or contains solid particles. You must
use it onlyif its appearance is the same as that of water. Check all of this before each
injection.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Humalog 100 units/ml KwikPen injectable solution contains
- The active ingredient is insulin lispro. Insulin lispro is prepared in the laboratory using a technology called “recombinant DNA”. It is a modified form of human insulin, and is therefore different from other insulins of human or animal origin. Insulin lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
- The excipients are m-cresol, glycerol, dibasic sodium phosphate 7H O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH.
Description of the appearance of Humalog KwikPen and contents of the pack
Humalog 100 units/ml KwikPen injectable solution is a sterile, clear and
colourless aqueous solution and contains 100 units of insulin lispro per millilitre (100 units/ml) of
injectable solution. Each Humalog KwikPen contains 300 units (3 millilitres). Humalog KwikPen is available
in a pack of 5 pre-filled pens or in a multi-pack of 2 packs of 5 pre-filled pens.
Not all pack sizes may be marketed. Humalog 100 units/ml
contained in the pre-filled pen is the same Humalog 100 units/ml contained in the cartridges of
Humalog 100 units/ml separately. The KwikPen simply has an integrated cartridge. When the
pre-filled pen is empty, you cannot reuse it.
Marketing authorisation holder and manufacturer
Humalog 100 units/ml KwikPen injectable solution is produced by:
- Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.
- Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI), Italy.
The marketing authorisation is held by Eli Lilly Nederland B.V.,
Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
For further information on this medicine, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
DeutschlandNederland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
INSTRUCTIONS FOR USE MANUAL
The text of the instructions for use manual is reported below.
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/
Humalog Mix25 100 units/ml KwikPen injectable suspension in a prefilled pen
insulin lispro
Each KwikPen delivers from 1 to 60 units in 1-unit increments.
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog Mix25 KwikPen is and what it is used for
- 2. What you need to know before you use Humalog Mix25 KwikPen
- 3. How to use Humalog Mix25 KwikPen
- 4. Possible side effects
- 5. How to store Humalog Mix25 KwikPen
- 6. Contents of the pack and other information
1. What is Humalog Mix25 KwikPen and what is it used for
Humalog Mix25 KwikPen is used for the therapy of diabetes. It is a premixed suspension.
The active ingredient contained in it is insulin lispro. 25% of the insulin lispro contained in
Humalog Mix25 KwikPen is dissolved in water and acts more quickly than normal human insulin
thanks to a small modification of the insulin molecule. 75% of the insulin lispro contained in
Humalog Mix25 KwikPen is present in suspension together with protamine sulfate, so that its
action is prolonged.
Your condition, diabetes, derives from the fact that your pancreas does not produce insulin in
sufficient quantity to control the level of glucose in the blood. Humalog Mix25 replaces the insulin produced
by your body and is used to control glucose in the long term. Humalog Mix25
acts very quickly and for longer than soluble insulin. As a rule, you should inject
Humalog Mix25 within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog Mix25 KwikPen and of an insulin with
information for its correct use. Do not change the type of insulin unless prescribed by your
doctor. Be very careful when changing the type of insulin.
The KwikPen is a disposable prefilled pen device containing 3 ml (300 units, 100 units/ml)
of insulin lispro. One KwikPen contains multiple doses of insulin. The KwikPen allows you to
select 1 unit at a time. The number of units is visible in the dosage window, always check it
before the injection.You can administer from 1 to 60 units in a single injection. If the dose
is higher than 60 units, you will need to administer more than one injection.
2. What you need to know before using Humalog Mix25 KwikPen
DO NOT use Humalog Mix25 KwikPen
- If you believe you are experiencing hypoglycemia(low blood sugar). Further instructions on how to manage mild hypoglycemia can be found later in this leaflet (see section 3: If you take more than the prescribed dose of Humalog Mix25).
- If you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).
Warnings and precautions
- Always check the packaging and label of the prefilled pen for the name and type of insulin you receive from the pharmacist. Make sure your Humalog Mix25 KwikPen packaging matches what your doctor has prescribed.
- If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of meals, frequency and intensity of exercise. You should also monitor your blood sugar level frequently by measuring it.
- Some people who have switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or diabetes center nurse.
- Have you been ill recently?
- Do you have problems with your liver or kidneys?
- Are you doing more exercise than usual?
- Your insulin needs may change if you consume alcohol.
- Also, inform your doctor, pharmacist or a diabetes center nurse if you are planning a trip abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with long-standing type 2 diabetes and heart disease or a previous cerebrovascular event who have been treated with pioglitazone and insulin have reported the development of heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
- This Pen should not be used by the blind or those with visual impairments without the assistance of a person trained to use the Pen.
Skin changes at the injection site
The injection site must be rotated to prevent skin changes, such as the appearance of
nodules under the skin. Insulin may not work as well as it should if you inject into
an area with nodules (see section How to use Humalog Mix25 KwikPen). If you are currently
injecting into an area with nodules, consult your doctor before starting to inject into
another area. Your doctor may advise you to check your blood sugar more carefully and adjust the
dose of insulin or other antidiabetic medications.
Other medicines and Humalog Mix25 KwikPen
Your insulin needs may change if you are taking
- the birth control pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- beta2-agonists (e.g. ritodrine, salbutamol, terbutaline),
- beta-blockers,
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) and
- angiotensin II receptor antagonists.
Tell your doctor if you are taking, have recently taken, or may take any other
medicines, including over-the-counter medicines (see section “Warnings and precautions”).
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase during the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and operating machinery
Your ability to concentrate and react may be reduced if you experience a hypoglycemic reaction.
Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using machinery). You should consult
your doctor about whether it is advisable to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia HumalogMix25 KwikPen contains sodiumThis medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
3. How to use Humalog Mix25 KwikPen
Always use Humalog Mix25 KwikPen exactly as your doctor has instructed you. If you have any doubts, you should consult your doctor. To prevent possible transmission of diseases, each pen must be used by only one patient, even if the needle is changed.
Dose
- Normally, you should inject Humalog Mix25 within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding the quantity, timing, and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example, from animal or human insulin to a Humalog product), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or it may be carried out gradually over several weeks or months.
- Humalog Mix25 KwikPen is only suitable for subcutaneous injections. Talk to your doctor if you need to inject the insulin by another method.
Preparation of Humalog Mix25 KwikPen
- Immediately before use, the KwikPen must be rotated ten times between the palms of your hands and inverted 180° ten times to resuspend the contents until the insulin appears uniformly cloudy or milky. If this does not happen, repeat the above procedure until the components are mixed. The cartridges are equipped with a small
glass ball that facilitates mixing. Do not shake vigorously, as this maneuver may cause foam to form, which may compromise the correct measurement of the dose. The cartridges should be examined frequently and should not be used if floating residues or white particles adhering to the bottom or walls of the cartridge are observed, which give it an icy appearance. Check all of this before each injection.
Preparing the KwikPen to make it ready for use (consult the instructions for use manual)
- First, wash your hands.
- Read the instructions on how to use your prefilled insulin pen and follow them scrupulously. Below are some important points.
- Always use a new needle (needles are not included in the package). Load the KwikPen each time before use. This allows you to check that insulin is flowing out and to eliminate any air bubbles from the KwikPen. Some small air bubbles may have remained in the pen; they are not dangerous, but if they are too large, they may make the dose to be injected less accurate.
Injection of Humalog Mix25
- Before making the injection, disinfect the skin according to the instructions you have received. Inject the medication subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used previously and remember to rotate the injection site, as you have been told.
After the injection
- As soon as you have finished the injection, remove the needle from the KwikPen using the outer needle cap. This will allow you to keep the insulin sterile, prevent leakage of the medication, stop air from entering the pen, and prevent the needle from becoming clogged. Do not share your needles with others. Do not share your pen with others. Reposition the cap on the pen.
Subsequent injections
- Each time you use a KwikPen, you must use a new needle. Before each injection, eliminate any air bubbles. You can check how much insulin is left by holding the KwikPen in a vertical position, with the needle pointing upwards. The graduation on the cartridge will indicate approximately the remaining units.
- Do not mix other insulins into your disposable pen. Once the KwikPen is empty, do not reuse it. Dispose of it carefully. Your pharmacist or the staff at the diabetes center will tell you how to do so.
If you use more Humalog Mix25 than you should
If you use more Humalog Mix25 than you should or are not sure how much you have injected, a decrease in blood sugar levels may occur. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia), eat glucose tablets, sugar, or drink a sugary beverage. Then eat fruit, biscuits, or a sandwich, as suggested by your doctor, and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and your breathing is short and your skin is turning pale, inform your doctor immediately. A glucagon injection can treat fairly severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you do not get a positive response with glucagon, you must be hospitalized. Ask your doctor for information on the use of glucagon.
If you forget to use Humalog Mix25
If you take less Humalog Mix25 than you need or are not sure how much you have injected, an increase in blood sugar levels may occur. Check your blood sugar level.
Hypoglycemia (low blood sugar level) or hyperglycemia (high blood sugar level) that is not adequately treated can become very serious and cause headache, nausea, vomiting, dehydration, loss of consciousness, coma, and even death (see paragraphs A and B of section 4 “Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always keep some syringes and a vial of Humalog Mix25, or a spare pen and cartridges, on hand in case you lose the KwikPen or it becomes damaged.
- Always carry a document indicating that you are diabetic.
- Always carry some sugar with you.
If you stop treatment with Humalog Mix25
If you take less Humalog Mix25 than you need, an increase in blood sugar levels may occur. Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Systemic allergy is rare (from ≥ 1/10,000 to <1/1,000). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
low blood pressure
fast heartbeat
sweating
If you think that Humalog Mix25 is causing you this type of allergy to insulin, tell your
doctor immediately.
Local allergy is common (from ≥ 1/100 to <1/10). In some people, the skin at the injection site may
become red, swollen and itchy. Usually, this reaction disappears within a few days or a few
weeks. If this happens, tell your doctor.
Lipodystrophy is uncommon (from ≥ 1/1,000 to <1/100). If you inject insulin too often in the same
place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy). Lumps under the
skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis). Insulin may not
work as well as it should if you inject it into an area with
lumps. Change the injection site with each injection to prevent these skin changes.
Edema has been reported (for example, swelling of the arms, ankles; fluid retention), in
particular at the beginning of insulin therapy or during a change in therapy to improve
blood sugar control.
Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.
Common problems with diabetes
- A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog Mix25 or other insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work done immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin requirements;
- worsening of pre-existing kidney or liver problems.
Alcohol and certain medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or agitation
headache
fast heartbeat
feeling unwell
cold sweat
If you are unable to recognize the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.
- B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
- not taking Humalog or other insulin;
- taking a dose of insulin lower than prescribed by your doctor;
- eating a much larger amount of food than allowed by your diet;
- fever, infection or a severe emotional upset.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy, rapid breathing and a fast pulse are serious symptoms. Seek immediate
medical attention.
- C.IllnessIf you have an illness, especially if you feel unwell or are sick, your insulin needs may change. Even when you are not eating normally, you still need insulin.Test your urine and blood; when you are ill, follow the precautions you already know and tell your doctor.
5. How to store Humalog Mix25 KwikPen
Before use, store Humalog Mix25 KwikPen in a refrigerator (2°C - 8°C). Do not freeze.
During use, store Humalog Mix25 KwikPen at room temperature (below 30°C) and
discard it after 28 days. Do not keep the product near a heat source or in direct sunlight. Do not store the KwikPen you are using in the refrigerator. The KwikPen should not be stored
with the needle inserted.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label and on the packaging. The
expiry date refers to the last day of the month.
Do not use this medicine if there are floating residues or white particles adhering to the bottom or
walls of the cartridge, which give it a frosted appearance. Check all of this before
each injection.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Humalog Mix25 100 units/ml KwikPen injectable suspension contains
- The active ingredient is insulin lispro. Insulin lispro is prepared in the laboratory using a technology called "recombinant DNA". It is a modified form of human insulin, and is therefore different from other insulins of human or animal origin. Insulin lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
- The excipients are protamine sulfate, m-cresol, phenol, glycerol, disodium phosphate heptahydrate, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been added to adjust the pH.
Description of the appearance of Humalog Mix25 100 units/ml KwikPen injectable suspension and
contents of the pack
Humalog Mix25 100 units/ml KwikPen injectable suspension is a sterile white suspension and
contains 100 units of insulin lispro per millilitre (100 units/ml) of injectable suspension. 25% of the
insulin lispro contained in Humalog Mix25 is dissolved in water. 75% of the insulin lispro
contained in Humalog Mix25 is present in suspension together with protamine sulfate. Each
Humalog Mix25 KwikPen contains 300 units (3 millilitres). Humalog Mix25 KwikPen is available in
a pack of 5 prefilled pens or in a multiple pack of 2 packs of 5 prefilled pens.
Not all pack sizes may be marketed. Humalog Mix25
contained in the KwikPen is the same Humalog Mix25 contained in the cartridges of Humalog Mix25
separate. The KwikPen simply has an integrated cartridge. When the KwikPen is empty, you cannot
reuse it.
Marketing authorisation holder and manufacturer
Humalog Mix25 100 units/ml KwikPen injectable suspension is manufactured by:
- Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.
- Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI), Italy.
The marketing authorisation is held by Eli Lilly Nederland B.V.,
Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
For further information on this medicine, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republikaMagyarország
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
INSTRUCTIONS FOR USE
The text of the instructions for use is reported below.
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/
Humalog Mix50 100 units/ml KwikPen injectable suspension in a prefilled pen
insulin lispro
Each KwikPen delivers from 1 to 60 units in 1-unit increments.
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog Mix50 KwikPen is and what it is used for
- 2. What you need to know before you use Humalog Mix50 KwikPen
- 3. How to use Humalog Mix50 KwikPen
- 4. Possible side effects
- 5. How to store Humalog Mix50 KwikPen
- 6. Contents of the pack and other information
1. What is Humalog Mix50 KwikPen and what it is used for
Humalog Mix50 KwikPen is used for the treatment of diabetes. It is a premixed suspension.
The active ingredient contained in it is insulin lispro. 50% of the insulin lispro contained in
Humalog Mix50 KwikPen is dissolved in water and acts more quickly than normal human insulin
thanks to a small modification of the insulin molecule. 50% of the insulin lispro contained in
Humalog Mix50 KwikPen is present in suspension together with protamine sulfate, so that its
action is prolonged.
Your condition, diabetes, is due to the fact that your pancreas does not produce enough insulin to
control the level of glucose in the blood. Humalog Mix50 replaces the insulin produced
by your body and is used to control glucose in the long term. Humalog Mix50
acts very quickly and for a longer time compared to soluble insulin. As a rule, you should inject
Humalog Mix50 within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog Mix50 KwikPen and a fast-acting insulin
information for its correct use. Do not change the type of insulin unless prescribed by a doctor.
Be very careful when changing the type of insulin.
The KwikPen is a disposable prefilled pen device containing 3 ml (300 units, 100 units/ml)
of insulin lispro. One KwikPen contains multiple doses of insulin. The KwikPen allows you to
select 1 unit at a time. The number of units is visible in the dosage window, always check it
before the injection.You can administer from 1 to 60 units in a single injection. If the dose
is higher than 60 units, you will need to administer more than one injection.
2. What you need to know before using Humalog Mix50 KwikPen
DO NOT use Humalog Mix50 KwikPen
- If you believe you are experiencing hypoglycemia(low blood sugar). Further instructions for managing mild hypoglycemia are contained in this leaflet (see section 3: If you take more than the prescribed dose of Humalog Mix50).
- If you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).
Warnings and precautions
- Always check the packaging and label of the prefilled pen to ensure the name and type of insulin you receive from the pharmacist are correct. Make sure your Humalog Mix50 KwikPen packaging matches what your doctor has prescribed.
- If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of meals, the frequency and intensity of exercise. You should also monitor your blood sugar level frequently by measuring it.
- Some people who switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you experience frequent hypoglycemia, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or diabetes center nurse.
- Have you been ill recently?
- Do you have problems with your liver or kidneys?
- Are you doing more exercise than usual?
- Your insulin needs may change if you drink alcohol.
- Also, inform your doctor, pharmacist or diabetes center nurse if you are planning a trip abroad. Differences in time zones between countries can lead to a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with long-standing type 2 diabetes and heart disease or a previous cerebrovascular event who were treated with pioglitazone and insulin have reported the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
- This Pen should not be used by the visually impaired or those with visual difficulties without the assistance of a person trained to use the Pen.
Skin changes at the injection site
The injection site must be rotated to prevent skin changes, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject into
an area with lumps (see section How to use Humalog Mix50 KwikPen). If you are currently
injecting into an area with lumps, consult your doctor before starting to inject into
another area. Your doctor may advise you to check your blood sugar more carefully and adjust
your insulin or other antidiabetic medication dose.
Other medicines and Humalog Mix50 KwikPen
Your insulin needs may change if you are taking
- the contraceptive pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- beta2-agonists (e.g. ritodrine, salbutamol, terbutaline),
- beta-blockers,
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) and
- angiotensin II receptor antagonists.
Tell your doctor if you are taking, have recently taken or may take any other
medicines, including those available without a prescription (see section “Warnings and precautions”).
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase in the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and operating machinery
Your ability to concentrate and react may be reduced if you experience a hypoglycemic reaction.
Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using machinery). You should consult
your doctor about whether it is safe to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia
Humalog Mix50 KwikPen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free”.
3. How to use Humalog Mix50 KwikPen
Always use Humalog Mix50 KwikPen exactly as your doctor has instructed. If you have any doubts, you should consult your doctor. To prevent possible transmission of diseases, each pen must be used by only one patient, even if the needle is changed.
Dose
- Normally, you should inject Humalog Mix50 within 15 minutes before your meal. If necessary, you can also inject it immediately after the meal. Regarding the quantity, timing and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or it may be carried out gradually over a period of weeks or months.
- Humalog Mix50 KwikPen is only suitable for subcutaneous injections. Talk to your doctor if you need to inject insulin in another way.
Preparation of Humalog Mix50 KwikPen
- Immediately before use, the KwikPen must be rotated ten times between the palms of your hands and inverted 180° ten times to resuspend the contents until the insulin appears uniformly cloudy or milky. If this does not happen, repeat the above procedure until the components are mixed. The cartridges are equipped with a small
glass ball that facilitates mixing. Do not shake vigorously, as this maneuver may cause foam to form which may compromise the correct measurement of the dose. The cartridges should be examined frequently and should not be used if floating debris or white particles adhering to the bottom or walls of the cartridge are observed, which give it an icy appearance. Check all of this before each injection.
Preparing the KwikPen to make it ready for use (refer to the instructions for use manual)
- First, wash your hands.
- Read the instructions on how to use your prefilled insulin pen and follow them scrupulously. Below are some important points.
- Always use a new needle (needles are not included in the package).
- Load the KwikPen each time before use. This allows you to check that insulin is flowing out and to eliminate any air bubbles from the KwikPen. Some small air bubbles may have remained in the pen; they are not dangerous, but if they are too large they may make the dose to be injected less accurate.
Injection of Humalog Mix50
- Before giving the injection, disinfect the skin according to the instructions you have received. Inject the medicine subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used last time and remember to rotate the injection site, as you have been told.
After the injection
- As soon as you have finished the injection, remove the needle from the KwikPen using the outer needle cap. This will allow you to keep the insulin sterile, prevent leakage of the medicine, stop air from entering the pen and prevent the needle from becoming clogged. Do not share your needles with others. Do not share your pen with others. Reposition the cap on the pen.
Subsequent injections
- Each time you use a KwikPen you must use a new needle. Before each injection, eliminate any air bubbles. You can check how much insulin is left by holding the KwikPen upright, with the needle pointing upwards. The graduation on the cartridge will approximately indicate the remaining units.
- Do not mix other insulins into your disposable pen. Once the KwikPen is empty, do not reuse it. Dispose of it carefully. Your pharmacist or the staff at the diabetes center will tell you how to do it.
If you use more Humalog Mix50 than you should
If you use more Humalog Mix50 than you should or are not sure how much you have injected, you may experience a decrease in your blood sugar level. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often sufficient to counteract mild hypoglycemia, or a moderate overdose of insulin. If you notice that you are getting worse and your breathing is short and your skin is pale, inform your doctor immediately. A glucagon injection can treat fairly severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you do not get a positive response with glucagon, you must be hospitalized. Ask your doctor for information on the use of glucagon.
If you forget to use Humalog Mix50
If you take less Humalog Mix50 than you need or are not sure how much you have injected, your blood sugar level may increase. Check your blood sugar level.
Untreated hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) can become very serious and cause headache, nausea, vomiting, dehydration, loss of consciousness, coma and even death (see paragraphs A and B of section 4 “Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always keep a spare pen and cartridges, in case you lose the KwikPen or it is damaged.
- Always carry a document indicating that you are diabetic.
- Always carry sugar with you.
If you stop treatment with Humalog Mix50
If you take less Humalog Mix50 than you need, your blood sugar level may increase. Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Systemic allergy is rare (from ≥ 1/10,000 to <1/1,000). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
low blood pressure
rapid heartbeat
sweating
If you believe that Humalog Mix50 is causing you this type of insulin allergy, inform your
doctor immediately.
Local allergy is common (from ≥ 1/100 to <1/10). In some people, the skin at the injection site may
appear red, swollen, and itchy. Usually, this reaction disappears within a few days or weeks. If this
occurs, inform your doctor.
Lipodystrophy is uncommon (from ≥ 1/1,000 to <1/100). If you inject insulin too often in the same
place, the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy). Nodules under the
skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis).
Insulin may not work as well as it should if you inject it into an area with
nodules. Change the injection site with each injection to prevent these skin changes.
Edema has been reported (e.g., swelling of the arms, ankles; fluid retention),
particularly at the beginning of insulin therapy or during a change in therapy to improve
blood glucose control.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the
national reporting system detailed in Annex V
By reporting side effects you can help provide more information on the safety
of this medicine.
Common diabetes problems
- A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog Mix50 or another insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work performed immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin requirements;
- worsening of pre-existing kidney or liver disease.
Alcohol and some medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia appear quickly and include:
tiredness
nervousness or agitation
headache
rapid heartbeat
feeling unwell
cold sweat
If you are unable to recognize the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.
- B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
- failure to take Humalog or another insulin;
- taking a dose of insulin lower than prescribed by your doctor;
- eating a much larger amount of food than allowed by your diet;
- fever, infection, or severe emotional stress.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms appear slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical attention.
- C.IllnessIf you become ill, especially if you feel unwell, your insulin needs may change. Even when you are not eating normally, you still need insulin.Test your urine and blood; when you are ill, follow the precautions you already know and inform your doctor.
5. How to store Humalog Mix50 KwikPen
Before use, store Humalog Mix50 KwikPen in a refrigerator (2°C - 8°C). Do not freeze.
During use, store Humalog Mix50 KwikPen at room temperature (below 30°C) and
discard it after 28 days. Do not keep the product near a heat source or in direct sunlight. Do not store the KwikPen you are using in the refrigerator. The KwikPen should not be stored
with the needle inserted.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The
expiry date refers to the last day of the month.
Do not use this medicine if you notice the presence of floating residues or white particles adhering to the
bottom or walls of the cartridge, which give it an icy appearance. Check all
this before each injection.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Content of the pack and other information
What Humalog Mix50 100 units/ml KwikPen injectable suspension contains
- The active ingredient is insulin lispro. Insulin lispro is made in the laboratory using a technology called "recombinant DNA". It is a modified form of human insulin, and is therefore different from other insulins of human or animal origin. Insulin lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
- The excipients are protamine sulfate, m-cresol, phenol, glycerol, disodium phosphate 7H O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been added to adjust the pH.
Description of the appearance of Humalog Mix50 100 units/ml KwikPen injectable suspension and
contents of the pack
Humalog Mix50 100 units/ml KwikPen injectable suspension is a sterile white suspension and
contains 100 units of insulin lispro per millilitre (100 units/ml) of injectable suspension. The
50% of the insulin lispro contained in Humalog Mix50 is dissolved in water. 50% of the insulin lispro
contained in Humalog Mix50 is present in suspension together with protamine sulfate. Each
Humalog Mix50 KwikPen contains 300 units (3 millilitres). Humalog Mix50 KwikPen is available in
a pack of 5 pre-filled pens or in a multiple pack of 2 packs of 5 pre-filled pens.
Not all pack sizes may be marketed. Humalog Mix50
contained in the KwikPen is the same Humalog Mix50 contained in the cartridges of Humalog Mix50
separate. The KwikPen simply has an integrated cartridge. When the KwikPen is empty, you cannot
reuse it.
Marketing authorisation holder and manufacturer
Humalog Mix50 100 units/ml KwikPen injectable suspension is produced by:
- Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.
- Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI), Italy.
The marketing authorisation is held by Eli Lilly Nederland B.V.,
Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
For further information on this medicine, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Eli Lilly Nederland" B.V. - Bulgaria
tel. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republikaMagyarország
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel:+ 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
INSTRUCTIONS FOR USE MANUAL
The text of the instructions for use manual is reported below.
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/
INSTRUCTIONS FOR USE MANUAL
KwikPen pre-filled insulin pen
100 units/ml
READ THIS MANUAL BEFORE USE
Read the Manual before using the insulin and each time you need to use KwikPen again. There may be new information. This information does not replace a discussion
with healthcare professionals regarding the clinical condition or treatment.
KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of
insulin. You can administer multiple doses using a single pen. The Pen allows you to
select 1 unit at a time. You can administer from 1 to 60 units in a single injection. If your
dose is greater than 60 units, you will need to administer more than one injection. The plunger moves only slightly with each injection and you may not notice the movement. The plunger
will reach the end of the cartridge only when you have used all 300 units in the Pen.
Do not share your Pen with other people, even if the needle has been changed. Do not reuse needles and do not share them with other people. It could cause an infection to the person you lent it to or
catch an infection from the person you lent it to.
This Pen should not be used by the blind or those with visual impairments without
the assistance of people trained to use the Pen.
Components of the KwikPen
Dose indicator
Components of the Pen needle
(needles are not included)
Paper
protection
Outer cap Inner
needle cap
Needle
of the needle
How to recognise the KwikPen:
Materials needed to administer:
- KwikPen containing the insulin
- Needle compatible with the KwikPen (BD [Becton, Dickinson and Company] pen needles are recommended)
- Swab soaked in disinfectant Needles and disinfectant swab are not included.
Preparing the Pen
- Wash your hands with soap and water.
- Check the Pen to make sure you are taking the correct type of insulin. This is particularly important if you use more than 1 type of insulin.
- Do notuse the Pen after the expiry date printed on the Label. After starting to use the Pen, discard the Pen after the period of use specified in the Package Leaflet has elapsed.
- Always use a new needlefor each injection. This helps prevent infections and needle blockages.
| Humalog Solution | Humalog Mix 25 Suspension (cloudy insulin) | or Humalog Mix50 Suspension (cloudy insulin) | |
| Pen Colour: | Blue | Blue | a Blue |
| Dose selector button: | Burgundy red (plum) | Yellow | m Red |
| Labels: | White with a strip of burgundy red (plum) | White with a strip of yellow | r a White with a strip of red |
Step 1:
- Remove the Pen cap.
- Do notremove the Pen label.
- Clean the rubber closure with a swab
- soaked in disinfectant.
Step 2:
(Only for HUMALOG insulin suspensions with a cloudy appearance)
- Gently rotate the Pen 10 times. And
- Turn the Pen upside down 10 times.
Mixing is importantto ensure you take the
correct dose.
The insulin should appear uniformly mixed.
Step 3:
- Check the appearance of the insulin.
- HUMALOG solution should appear clear and colourless. Do notuse it if it appears cloudy, coloured, or if it contains particles or lumps.
- HUMALOG suspension - cloudy insulin - should appear white after mixing. Do notuse it if it appears clear or if it contains particles or lumps.
Step 4:
- Choose a new needle.
- Remove the paper protection from the outer cap of the needle.
Step 5:
- Insert the needle covered by the cap straight onto the end of the Pen and rotate the needle until it is firmly attached.
Step 6:
- Remove the outer cap of the needle. Do notthrow it away.
- Remove the inner cap of the needle and throw it away.
Loading the Pen
Load the Pen before each injection.
- Loading the Pen means removing air from the needle or cartridge that may form during normal use and ensuring that the Pen works correctly.
- If you do notperform this loading before each injection, you may inject too much or too little insulin.
Step 7:
- To load the Pen, select 2 units by rotating the dose selector button.
Step 8:
- Hold the Pen with the needle pointing upwards. Tap the cartridge to collect the air on the surface.
Step 9:
- Continue holding the Pen with the needle pointing upwards. Press the dose selector button until it stops, and a “ 0” appears in the dosage window. Keep the dose selector button pressed and count slowlyto 5. You should see insulin at the tip of the needle.
- If insulin does notappear, repeat the loading operations, but no more than 4 times.
- If insulin still does notappear, change the needle and repeat the loading operations. Small air bubbles are normal and do not interfere with the dosage.
Selecting the dose
- You can administer from 1 to 60 units in a single injection.
- If the dose is greater than 60 units, you will need to administer more than one injection.
- If you need to decide how to divide the dose, ask healthcare professionals.
- You must use a new needle for each new injection and repeat the loading operation.
Point 10:
- Rotate the dose selector button to the number of units to inject. The dose indicator must be aligned with the dose.
- The Pen allows you to select 1 unit at a time.
- The dose selector button clicks when you rotate it.
- DO NOTselect the dose by counting the number of clicks because it could select an incorrect dose.
- The dose can be corrected by rotating the dose selector button in either direction until the correct dose is aligned with the dose indicator. (Example: 12 units shown in the dosage window)
- Even numbers are printed on the dial.
- Odd numbers after the number 1 are displayed as solid lines.
- Always check the number in the dosage windowto make sure you haveselected the correct dose.(Example: 25 units shown in the dosage window)
- The Pen will not allow you to select more units than are available in the Pen.
- If you need to administer more units than are available in the pen you can:
- administer the amount remaining in the Pen and then use a new Pen to add the rest of the dose, or
- take a new Pen and administer the full dose.
- It is normal to see a small amount of insulin remaining in the Pen that cannot be injected.
Injecting the dose
- Inject the insulin as your healthcare professional has shown you.
- Change (rotate) the injection site for each injection.
- Do nottry to change the dose while you are making the injection.
Point 11:
- Choose the injection site. Insulin is injected under the skin (subcutaneous injection) of the abdomen, buttocks, thighs, or upper arms.
- Clean the skin with a swab soaked in disinfectant and wait for the skin to dry before injecting the dose.
Point 12:
- Insert the needle into the skin.
- Press the dose selector button all the way down.
- Continue to hold the dose selector button down and count slowlyto 5before removing the needle. 5 sec
Do nottry to inject the insulin by rotating the button
selector. Rotating the dose selector button will notdeliver your insulin dose.
Point 13:
- Remove the needle from the skin.
- A drop of insulin remaining on the tip of the needle is normal. It will not affect the dose administered.
- Check the number that appears in the dosage window.
- If you see “0” in the dosage window, it means you have administered the entire selected dose.
- If you do not see “0” in the dosage window, do not reselect the dose. Insert the needle into the skin and finish your injection.
- If you think you have not yetreceived the entire dose you selected for the injection, do notrestart or repeat the injection. Check your blood glucose level as instructed by your healthcare professional.
- If you normally need 2 injections to administer your entire dose, make sure to administer the second dose.
The plunger moves slightly with each injection and
you may not notice the movement.
If you see blood after removing the needle from the skin, gently press
on the injection site with a gauze or a swab
soaked in disinfectant. Do notrub the affected area.
After the injection
Point 14:
- Carefully replace the outer cap on the needle.
Point 15:
- Unscrew the needle covered by the cap and dispose of it as described below (see the section Disposal of the Pen and needles).
- Do not store the Pen with the needle inserted to prevent leakage, needle blockage, and air from entering the Pen.
Point 16:
- Reposition the cap on the Pen by holding it with the cap clip aligned with the dose indicator and press straight onto the Pen.
Disposal of the Pen and needles
- Place used needles in a closable container specifically for sharp or hard plastic waste with a secure lid. Do notthrow needles directly into household waste containers.
- Do notrecycle the container once it is full of needles.
- Ask your healthcare professional for available options for proper disposal of the Pen and the container.
- Instructions regarding needle handling should not replace local institutional or healthcare professional regulations.
Storage instructions for the Pen
Unused Pens
- Store unused Pens in the refrigerator at a temperature between 2°C and 8°C.
- Do notfreeze the insulin. Do notuse it if it has been frozen.
- Unused Pens can be used until the expiration date printed on the label, if the Pen has been stored in the refrigerator.
Pen in use
- Store the Pen you are currently using at room temperature (below 30°C) and away from dust, food and liquids, heat and light.
- Throw away the Pen you are using after the time specified in the Package Insert, even if it still contains insulin inside.
General safety information and effective use of the Pen
- Keep the Pen and needles out of the sight and reach of children.
- Do notuse the Pen if any part of it appears broken or damaged.
- Always carry an extra Pen with you in case you lose or damage it.
Troubleshooting
- If you cannot remove the cap of the Pen, gently rotate it back and forth, and then pull it off.
- If you have difficulty pushing the dose selector button:
- Pushing the dose selector button more slowly may make injection easier.
- The needle may be blocked. Insert a new needle and prime the Pen.
- There may be dust, food or liquids inside the Pen. Discard the Pen and take a new one. You may need to request a prescription from your doctor.
For further information or if you have problems with the KwikPen, contact your healthcare professional for
assistance or contact your local Eli Lilly branch.
Document revision date:
Humalog 200 units/ml KwikPen injectable solution in a prefilled pen
insulin lispro
Each KwikPen delivers from 1 to60units in 1-unit increments.
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog 200 units/ml KwikPen is and what it is used for
- 2. What you need to know before you use Humalog 200 units/ml KwikPen
- 3. How to use Humalog 200 units/ml KwikPen
- 4. Possible side effects
- 5. How to store Humalog 200 units/ml KwikPen
- 6. Contents of the pack and other information
1. What is Humalog 200 units/ml KwikPen and what is it used for
Humalog 200 units/ml KwikPen is used for the therapy of diabetes. Humalog acts more
quickly than normal human insulin, as insulin lispro is a slightly
modified form of human insulin. Insulin lispro is structurally similar to human insulin, which is a
natural hormone produced by the pancreas.
Your condition, diabetes, derives from the fact that your pancreas does not produce insulin in sufficient
quantity to control blood glucose levels. Humalog replaces the insulin produced by your
body and is used to control glucose in the long term. The medicine acts very
quickly and lasts for a shorter period of time compared to a soluble insulin (from 2 to 5 hours). You should normally inject Humalog within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog 200 units/ml KwikPen and a long-acting insulin
information for its correct use. Do not change the type of insulin unless prescribed by your
doctor.
Humalog 200 units/ml KwikPen should be reserved for the treatment of adults with diabetes who
require daily doses greater than 20 units of rapid-acting insulin.
Humalog 200 units/ml KwikPen is a disposable prefilled pen device containing 3 ml
(600 units, 200 units/ml) of insulin lispro. One KwikPen contains multiple doses of insulin. The
KwikPen allows you to select 1 unit at a time. The number of units is visible in the
dosage window, always check it before the injection.You can administer from 1 to 60 units in a
single injection. If the dose is greater than 60 units, you will need to administer more than one injection.
2. What you need to know before using Humalog 200 units/ml KwikPen
DO NOT use Humalog 200 units/ml KwikPen
- If you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).
- If you believe you are developing a situation of hypoglycemia(low blood sugar). Further instructions for dealing with mild hypoglycemia can be found later in this leaflet (see section 3: If you use more Humalog than you should).
Warnings and precautions
- Always check the packaging and the label of the prefilled pen for the name and type of insulin you are given by the pharmacist. Make sure the Humalog 200 units/ml KwikPen packaging corresponds to what your doctor has prescribed.
- Humalog 200 units/ml injectable solution in the prefilled pen (the KwikPen) mustonly be injected using this prefilled pen. Do not transfer insulinlispro from Humalog 200 units/ml KwikPen to a syringe.The scale on the insulin syringe will not indicate the correct dose. A serious overdose may occur, causing low blood sugar, which could endanger your life. Do not transfer insulin from Humalog 200 units/ml KwikPen to any other insulin delivery device such as insulin infusion pumps.
- DO NOT mix Humalog 200 units/ml injectable solution in the prefilled pen (theKwikPen) with any other insulin or with any other medicine.Humalog 200 units/ml injectable solution must not be diluted.
- If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is getting too low. The warning signs are listed later in this leaflet in section 4. You must pay close attention to the timing of meals, the frequency and intensity of exercise. You should also closely monitor your blood sugar level by measuring it frequently.
- Some people who switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you experience hypoglycemia frequently, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
- Have you been recently ill?
- Do you have liver or kidney problems?
- Are you doing more exercise than usual?
- Also, tell your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with type 2 diabetes diagnosed for a long time and with heart disease or a previous cerebrovascular event who were treated with pioglitazone and insulin have reported the development of heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
- This Pen should not be used by the visually impaired or those with poor vision without the assistance of a person trained to use the Pen.
Skin changes at the injection site
The injection site must be rotated to prevent skin changes, such as the appearance of
nodules under the skin. Insulin may not work as well as it should if you inject into
an area with nodules (see section How to use Humalog 200 units/ml KwikPen). If you are currently
injecting into an area with nodules, consult your doctor before starting to inject
in another area. Your doctor may advise you to check your blood sugar more carefully and adjust the
dose of insulin or other antidiabetic medicines.
Other medicines and Humalog 200 units/ml KwikPen
Your insulin needs may change if you are taking
- the birth control pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents (e.g. metformin, acarbose, sulfonylureas, pioglitazone, empagliflozin, DPP-4 inhibitors such as sitagliptin or saxagliptin)
- acetylsalicylic acid,
- sulfonamide antibiotics,
- somatostatin analogs (such as octreotide, used to treat a rare condition in which you produce too much growth hormone),
- “beta2-agonists” such as salbutamol or terbutaline for the treatment of asthma, or ritodrine used to stop premature labor,
- “beta-blockers” for the treatment of hypertension, or
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol (a medicine that affects ovulation)
- some angiotensin converting enzyme (ACE) inhibitors used to treat certain heart conditions or hypertension (e.g. captopril, enalapril) and
- specific medicines for the treatment of hypertension, kidney damage due to diabetes and some heart disorders (angiotensin II receptor blockers).
Tell your doctor if you are taking or have recently taken or may take any other
medicine (see also section “Warnings and precautions”).
Humalog with alcohol
Drinking alcohol can change (increase or decrease) your blood sugar level. For
this reason, the amount of insulin you need may change.
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase in the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or
your diet.
Ask your doctor for advice.
Driving and using machines
Your ability to concentrate and react may be reduced if you have a hypoglycemic reaction.
Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using machinery). You should consult
your doctor about whether it is appropriate to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia
Humalog 200 units/ml KwikPen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
3. How to use Humalog 200 units/ml KwikPen
Always use this medicine exactly as your doctor has told you. If you have any doubts, you should
consult your doctor. To prevent possible transmission of diseases, each pen should be
used by only one patient, even if the needle is changed.
Humalog 200 units/ml KwikPen is indicated for patients who take more than 20 units of rapid-acting insulin
per day.
Do not transfer lispro insulin from Humalog 200 units/ml KwikPen to a syringe. The scale
on the insulin syringe will not indicate the correct dose. A serious
overdose may occur, causing a lowering of blood sugar levels, which may endanger your
life.
Do not use Humalog 200 units/ml KwikPen injectable solution in an insulin infusion pump.
Dose
- Normally, you should inject Humalog within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding quantity, timing and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medicine (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
- Inject Humalog under the skin (subcutaneously).
Preparation of Humalog 200 units/ml KwikPen
- Humalog is already dissolved in water, so you do not need to mix it. However, be careful to use it onlyif its appearance is the same as that of water. The solution must be clear, colorless and free of solid particles. Check this before each injection.
Preparation of the KwikPen to make it ready for use (see the instruction manual
for use)
- First, wash your hands.
- Read the instructions on how to use the prefilled insulin pen and follow them carefully. Some important points are listed below.
- Always use a new needle (needles are not included in the package).
- Prime the KwikPen each time before use. This allows you to check that insulin is flowing out and to eliminate any air bubbles from the KwikPen. Some small air bubbles may have remained in the pen; they are not dangerous, but if they are too large they may make the insulin dose less accurate.
Injection of Humalog
- Before making the injection, disinfect the skin according to the instructions you have received. Inject the medicine subcutaneously, as you have been taught. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the previous one and remember to rotate the injection site, as you have been taught. It does not matter which injection site you use, whether it is the upper arms, thighs, buttocks or abdomen, the injection of Humalog will have an even faster action than soluble human insulin.
- Do not inject Humalog 200 units/ml KwikPen injectable solution directly into a vein (intravenously).
After the injection
- As soon as you have finished the injection, remove the needle from the KwikPen using the outer cap of the needle. This will allow you to keep the insulin sterile, prevent leakage of the medicine, stop air from entering the pen and prevent the needle from becoming clogged. Do not share your needles with others. Do not share the pen with others. Reposition the cap on the pen.
Subsequent injections
- Each time you use a KwikPen you must use a new needle. Before each injection, eliminate any air bubbles. You can check how much insulin is left in the KwikPen by holding it upright, with the needle pointing upwards.
- Once the KwikPen is empty, do not reuse it. Dispose of it carefully. Your pharmacist or the staff at the diabetes center will tell you how to do it.
If you use more Humalog than you should
If you use more Humalog than you should or are not sure how much you have injected, a
decrease in blood sugar levels may occur. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a modest insulin overdose. If you notice that you are getting worse and your breathing is short
and your skin turns pale, inform your doctor immediately. A glucagon injection can treat
fairly severe hypoglycemia. Take glucose or sugar after the glucagon injection. If
you do not get a positive response with glucagon, you should go to hospital. Ask your doctor
for information on the use of glucagon.
If you forget to use Humalog
If you take less Humalog than you need or are not sure how much you have injected, an
increase in blood sugar levels may occur. Check your blood sugar level.
Hypoglycemia (low blood sugar level) or hyperglycemia (high blood sugar level)
left untreated can become very serious and cause headache, feeling unwell
(nausea), feeling sick (vomiting), fluid loss (dehydration), loss of consciousness, coma and even
death (see section 4 “Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always carry a spare pen with you, in case you lose the KwikPen or it becomes damaged.
- Always carry a document with you proving that you have diabetes.
- Always carry sugar with you.
If you stop treatment with Humalog
If you take less Humalog than you need, an increase in blood sugar levels may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergy is rare (may affect up to 1 in 1,000 people). The symptoms are:
rash all over the body
difficulty breathing
low blood pressure
fast heartbeat
shortness of breath sweating
If you think that Humalog is causing you this type of insulin allergy, tell your doctor immediately.
Local allergy is common (may affect up to 1 in 10 people). In some people, the skin in the area
around the injection site may become red, swollen and itchy. Usually, this reaction disappears in a few days or weeks. If this happens, tell your doctor.
Lipodystrophy is uncommon (may affect up to 1 in 100 people). If you inject insulin too
often in the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy).
Lumps under the skin can also be caused by the build-up of a protein called
amyloid (cutaneous amyloidosis). Insulin may not work as well as it should if you inject
into an area with lumps. Change the injection site with each injection to prevent these
skin changes.
Edema has been reported (for example, swelling of the arms, ankles; fluid retention), in
particular at the beginning of insulin therapy or during a change in therapy to improve
blood sugar level control.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system indicated in Annex V .
By reporting side effects you can help provide more information on the safety
of this medicine.
Common problems of diabetes
Hypoglycemia
Hypoglycemia (low blood sugar) means that there is not enough sugar in the
blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog or another insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work done immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin needs;
- worsening of pre-existing kidney or liver disease.
Alcohol and some medicines can interfere with blood sugar levels (see
paragraph 2).
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or agitation
headache
fast heartbeat
feeling unwell
cold sweat
If you are unable to recognise the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.
Hyperglycemia and diabetic ketoacidosis
Hyperglycemia (too much sugar in the blood) means that there is not enough
insulin in your body. Hyperglycemia can be caused by:
- not taking Humalog or another insulin;
- taking a dose of insulin lower than that prescribed by your doctor;
- eating a much larger amount of food than allowed by your diet;
- fever, infection or severe emotional stress.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical
attention.
Illness
If you have an illness, especially if you feel unwell or are certain you are ill, your insulin
needs may change. Even when you are not eating normally, you still need
insulin.Test your urine and blood; when you are ill, follow the “relative precautions” and
tell your doctor.
5. How to store Humalog 200 units/ml KwikPen
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging. The
expiry date refers to the last day of that month.
Before use, store Humalog 200 units/mlKwikPen in a refrigerator (2°C - 8°C). Do not freeze.
During use, store Humalog 200 units/mlKwikPen at room temperature (below 30°C)
and discard it after 28 days. Do not keep the medicine near a heat source or in direct
sunlight. Do not store the KwikPen that you are using in the refrigerator. The KwikPen must not be
stored with the needle inserted.
Do not use this medicine if you notice that the solution is coloured or contains solid particles. You must
use it onlyif its appearance is the same as that of water. Check all of this before each
injection.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Humalog 200 units/ml KwikPen injectable solution contains
- The active ingredient is insulin lispro. Each ml of injectable solution contains 200 units (U) of insulin lispro. Each prefilled pen (3 ml) contains 600 units (U) of insulin lispro.
- The excipients are metacresol, glycerol, trometamol, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been added to adjust the pH.
Description of the appearance of Humalog 200 units/ml KwikPen and contents of the pack
Humalog 200 units/ml KwikPen injectable solution is a sterile, clear and
colourless aqueous solution and contains 200 units of insulin lispro per millilitre (200 units/ml) of
injectable solution. Each Humalog 200 units/mlKwikPen contains 600 units (3 millilitres). Humalog
200 units/mlKwikPen is available in packs of 1, 2 or 5 prefilled pens or in multipacks of 2 packs of 5 prefilled pens each. Not all pack sizes may be marketed. The KwikPen simply has an integrated cartridge. When the prefilled pen is empty, you cannot reuse it.
Marketing Authorisation Holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
Manufacturer
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France
Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI), Italy.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България
тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.i filiaal
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
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ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
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Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
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Lilly S.A.
Tel: + 34-91 663 50 00
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Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
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Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
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Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
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Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
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Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
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Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
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Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
INSTRUCTIONS FOR USE
The text of the instructions for use is reported below.
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/
INSTRUCTIONS FOR USE
Humalog 200 units/ml KwikPen injectable solution in a prefilled pen
insulin lispro
READ THIS INSTRUCTION MANUAL BEFORE USE
Read the Instruction Manual before using Humalog 200 units/ml KwikPen solution
injectable and each time you need to use Humalog 200 units/ml KwikPen again. There may be
new information. This information does not replace a discussion with healthcare professionals
regarding your medical condition or treatment.
Humalog 200 units/ml KwikPen (“Pen”) is a disposable prefilled pen containing 3 ml
(600 units, 200 units/ml) of insulin lispro injectable solution. You can administer multiple doses
using a single pen. The Pen allows you to select 1 unit at a time. You can administer from
1 to 60 units in a single injection. If your dose is greater than 60 units you will need to
administer more than one injection. The plunger moves only slightly with each injection and
you may not notice the movement. The plunger will reach the end of the cartridge only when
you have used all 600 units in the Pen.
This pen is designed to allow you to inject higher doses than other pens
you may have used in the past. Select the usual dose as instructed by healthcare
professionals.
Humalog KwikPen is available in two concentrations, 100 units/ml and 200 units/ml. Inject
Humalog 200 units/ml ONLY using the Pen. DO NOT transfer insulin from the Pen to
any other insulin delivery device.
Syringes and insulin infusion pumps will not deliver 200 units/ml of insulin correctly.
A serious overdose may occur, causing a drop in blood sugar levels, which may endanger your life.
Do not share your Pen with other people, even if the needle has been changed. Do not reuse needles and do not share them with other people. You could cause an infection to the person you lent it to or
catch an infection from the person you borrowed it from.
This Pen should not be used by the blind or those with visual impairments without
the assistance of people trained to use the Pen.
Components of the KwikPen
Components of the Pen needleDose selector button
(needles are not included)with burgundy (plum) colored ring
Needle
Outer needle cap
Inner needle capNeedle
protectionpaper
How to recognize Humalog 200 units/ml KwikPen:
- Pen color: Dark gray
- Dose selector button: Dark gray with a burgundy (plum) colored ring on the end
- Labels: Burgundy (plum) color, with the inscription “200 units/ml” in a yellow box Yellow warning on the cartridge container
Materials needed to administer the dose:
- Humalog 200 units/ml KwikPen
- Needle compatible with the KwikPen (BD [Becton, Dickinson and Company] recommended needles)
- Disinfectant swab Needles and disinfectant swab are not included.
Preparing the Pen
- Wash your hands with soap and water.
- Check the Pen to make sure you are taking the correct type of insulin. This is especially important if you use more than 1 type of insulin.
- Do not usethe Pen after the expiration date printed on the Label or for more than 28 days from when you started using the Pen.
- Always use a new needlefor each injection. This helps prevent infections and needle blockages.
Step 1:
Remove the cap from the Pen.
- Do notremove the label from the Pen.
Clean the rubber closure with a swab
soaked in disinfectant.
Humalog 200 units/ml injectable solution must
appear clear and colorless. Do not use it if it has a
cloudy, colored appearance or if it contains
particles or clumps.
Step 2:
Choose a new needle.
Remove the paper protection from the outer cap
of the needle.
Step 3:
Insert the needle covered by the cap straight onto the end of the Pen and rotate the needle
until it is firmly attached.
Step 4:
Remove the outer cap of the needle. Do not
throw it away.
Remove the inner cap of the needle and throw it
away.
Loading the Pen
Load the Pen before each injection.
- Loading the Pen means removing air from the needle or cartridge that may form during normal use and ensuring that the Pen works correctly.
- If you do not load it before each injection, you may inject too much or too little insulin.
Step 5:
To load the Pen, select 2 units
by rotating the dose selector button.
Step 6:
Hold the Pen with the needle pointing upwards.
Tap the cartridge to collect the air on the
surface.
Step 7:
Continue to hold the Pen with the needle pointing upwards. Press the dose selector button
until it stops, and a “ 0” appears in the
dosage window. Keep the dose selector button pressed and count slowly to 5.
- You should see insulin at the tip of the needle.
- If insulin does notappear, repeat the loading operations, but no more than 8 times.
- If insulin still does not appear, change the needle and repeat the loading operations. Small air bubbles are normal and will not interfere with the dosage.
Selecting the dose
This pen is designed to allow you to inject the dose that is shown in the
window. Select the usual dose as instructed by healthcare professionals.
- You can administer from 1 to 60 units in a single injection.
- If the dose is greater than 60 units you will need to administer more than one injection.
- If you need to decide how to divide the dose, ask healthcare professionals.
- You must use a new needle for each new injection and repeat the loading operation.
Step 8:
Rotate the dose selector button until the
number of units to inject. The indicator of
the dose must be aligned with the dose.
- The Pen allows you to select 1 unit at a time.
- The dose selector button clicks when you rotate it.
- DO NOT select the dose by counting the number of clicks because you could select the wrong dose.
- The dose can be corrected by rotating the dose selector button in any direction until the correct dose is aligned with the dose indicator.
- Evennumbers are printed on the dial.
- Oddnumbers after the number 1 are displayed as solid lines.
Always check the number in the dosage window to make sure you have selected the
correct dose.
(Example: 12 units shown in the dosage
window)
(Example: 25 units shown in the dosage
window)
- The Pen will not allow you to select more than the number of units remaining in the Pen.
- If you need to administer more than the number of units remaining in the Pen, you can:
- administer the amount remaining in the Pen and then use a new Pen to add the rest of the dose, or
- take a new Pen and administer the full dose.
Injecting the dose
- Inject the insulin as healthcare professionals have shown you.
- Change (rotate) the injection site for each injection.
- Do nottry to change the dose while you are administering the injection.
Step 9:
Choose the injection site.
Humalog 200 units/ml injectable solution is
injected under the skin (subcutaneous injection)
of the abdominal area, buttocks, thighs or
upper arms.
Clean the skin with a disinfectant swab and wait for the skin to dry
before injecting the dose.
Step 10:
Insert the needle into the skin.
Press the dose selector button all the way down.
Continue to hold the
dose selector button pressed and count
slowly to 5before
removing the needle.
Do not try to inject the insulin by rotating the
dose selector button. Rotating the dose selector button will NOT deliver your dose of
insulin.
Step 11:
Remove the needle from the skin.
- A drop of insulin remaining on the tip of the needle is normal. It will not affect the administered dose.
Check the number that appears in the dosage
window.
- If you see “0” in the dosage window, it means you have administered the entire selected dose.
- If you do not see “0” in the dosage window, do not reselect the dose. Insert the needle into the skin and finish your injection.
- If you think you have not yetreceived the entire dose you selected for the injection, do not restart or repeatthe injection.Check your blood glucose level as instructed by
healthcare professionals.
The plunger moves only slightly with each
injection and you may not notice the
movement.
If you see blood after removing the needle from
the skin, gently press on the injection site with
a gauze or disinfectant swab.
Do notrub the affected area.
After the injection
Step 12:
Carefully replace the outer cap
on the needle.
Step 13:
Unscrew the needle covered by the cap and throw it
away as described below (see the section
Disposing of the Pen and Needles).
Do not store the Pen with the needle inserted to prevent leaks, needle blockage, and
air from entering the Pen.
Step 14:
Reposition the cap on the Pen holding
it with the clip of the cap aligned with
the dose indicator and press straight
against the Pen.
Disposal of the Pen and Needles
- Place used needles in a closable container specifically for sharp or hard plastic waste with a secure lid. Do not throw needles directly into household waste containers.
- Do not recycle the container once it is filled with needles.
- Ask healthcare professionals about available options for appropriate disposal of the pen and such container.
- Instructions regarding needle handling should not replace local institutional or healthcare personnel regulations.
Storage Instructions for the Pen
Unused Pens
- Store unused Pens in the refrigerator at a temperature between 2°C and 8°C.
- Do notfreeze Humalog 200 units/ml injectable solution. Do notuse it if it has been frozen.
- Unused Pens can be used up to the expiration date printed on the label, if the Pen has been stored in the refrigerator. Pen in use
- Store the Pen you are currently using at room temperature (below 30°C) and protected from dust, food and liquids, heat and light.
- Throw away the Pen you are using after 28 days, even if it still contains insulin inside.
General Safety Information and Effective Use of the Pen
- Keep the Pen and needles out of sight and reach of children.
- Do notuse the Pen if any part of it appears broken or damaged.
- Always carry an extra Pen with you in case you lose or damage it.
Troubleshooting
- If you cannot remove the Pen cap, gently rotate it back and forth, and then pull it off.
- If you have difficulty pushing the dose selector button:
- Pushing the dose selector button more slowly may make injection easier.
- The needle may be blocked. Insert a new needle and prime the Pen.
- There may be dust, food or liquids inside the Pen. Discard the Pen and take a new one. You may need to request a prescription from your doctor.
- Do not transfer insulin from the Pen to a syringe or insulin microinfuser. Severe overdose may occur.
For further information or if you have problems with Humalog 200 units/ml KwikPen, contact healthcare personnel for assistance or contact your local Eli Lilly branch.
Document revision date:
Humalog 100 units/ml Junior KwikPen injectable solution in a prefilled pen
insulin lispro
Each Junior KwikPen delivers from 0.5 to 30 units in increments of 0.5 units at a time
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog Junior KwikPen is and what it is used for
- 2. What you need to know before you use Humalog Junior KwikPen
- 3. How to use Humalog Junior KwikPen
- 4. Possible side effects
- 5. How to store Humalog Junior KwikPen
- 6. Contents of the pack and other information
1. What is Humalog Junior KwikPen and what is it used for
Humalog Junior KwikPen is used for diabetes therapy. Humalog acts more quickly
than normal human insulin, thanks to a small modification of the insulin molecule. Insulin
lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
Your condition, diabetes, stems from the fact that your pancreas does not produce insulin in sufficient
quantity to control blood glucose levels. Humalog replaces the insulin produced by your
body and is used to control glucose in the long term. The drug acts very
quickly and lasts for a shorter period of time compared to a soluble insulin (from 2 to 5 hours). You should
normally inject Humalog within 15 minutes before a meal.
Your doctor may prescribe both the use of Humalog and a long-acting insulin. Each type
correct use. Do not change the type of insulin unless prescribed by your doctor.
The use of Humalog is suitable for both adults and children.
Humalog 100 units/ml Junior KwikPen is a disposable pre-filled pen device containing
3 ml (300 units, 100 units/ml) of insulin lispro. One KwikPen contains multiple doses of insulin. The
KwikPen allows you to select half a unit (0.5 units) at a time. The number of units is visible
in the dosage window, always check it before the injection.You can administer from
0.5 units to 30 units in a single injection. If the dose is greater than 30 units, you will need to administer
more than one injection.
2. What you need to know before you use Humalog Junior KwikPen
DO NOT use Humalog Junior KwikPen
- If you are allergicto insulin lispro or any of the other ingredients of this medicine (listed in section 6).
- If you think you are developing hypoglycemia(low blood sugar). Further instructions on how to treat mild hypoglycemia can be found later in this leaflet (see section 3: If you use more Humalog than you should).
Warnings and precautions
- Always check the packaging and the pen label to ensure the name and type of insulin you receive from the pharmacist is correct. Make sure your Humalog 100 units/ml Junior KwikPen pack corresponds to what your doctor has prescribed.
- DO NOT mix Humalog 100 units/ml injectable solution in the prefilled pen (theJunior KwikPen) with any other insulin or with any other medicine.
- If your blood glucose level is well controlled with your current insulin therapy, you may not notice the warning signs when your blood sugar is getting too low. The warning signs are listed later in this leaflet in section 4. You must pay close attention to the timing of meals, frequency and intensity of exercise. You should also monitor your blood sugar level frequently by measuring it.
- Some people who switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or diabetes center nurse.
- Have you been ill recently?
- Do you have problems with your liver or kidneys?
- Are you doing more exercise than usual?
- Also, tell your doctor, pharmacist or diabetes center nurse if you are planning to travel abroad. Differences in time zones between countries can lead to changes in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with long-standing type 2 diabetes and heart disease or a previous stroke who were treated with pioglitazone and insulin have reported developing heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or swelling of the ankles or feet (edema).
- This Pen should not be used by the visually impaired or those with poor eyesight without the assistance of people trained to use the Pen.
Changes to the skin at the injection site
The injection site should be rotated to prevent changes to the skin, such as the development of
lumps under the skin. Insulin may not work as well if you inject into an area with lumps (see section How to use Humalog Junior KwikPen). If you are currently injecting into an area with lumps, consult your doctor before starting to inject into a
different area. Your doctor may advise you to check your blood glucose more carefully and adjust your
insulin dose or other diabetes medicines.
Other medicines and Humalog Junior KwikPen
Your insulin needs may change if you are taking
- the birth control pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents (e.g. metformin, acarbose, sulfonylureas, pioglitazone, empagliflozin, DPP-4 inhibitors such as sitagliptin or saxagliptin)
- acetylsalicylic acid,
- sulfonamide antibiotics,
- somatostatin analogs (such as octreotide, used to treat a rare condition in which you produce too much growth hormone),
- “beta2-agonists” such as salbutamol or terbutaline for the treatment of asthma, or ritodrine used to stop premature labor,
- “beta-blockers” for the treatment of high blood pressure, or
- certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol (a medicine that affects ovulation)
- certain angiotensin converting enzyme (ACE) inhibitors used to treat certain heart conditions or high blood pressure (e.g. captopril, enalapril) and
- specific medicines for the treatment of high blood pressure, kidney damage due to diabetes and certain heart disorders (angiotensin II receptor blockers).
Tell your doctor if you are taking, have recently taken or might take any other
medicines (see section “Warnings and precautions”).
Humalog with alcohol
Drinking alcohol can change (increase or decrease) your blood sugar level. Therefore,
the amount of insulin you need may change.
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase during the following six months. If
you are breastfeeding, you may need to change the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and using machines
Your ability to concentrate and react may be reduced if you have a hypoglycemic reaction.
Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using machinery). You should consult your
doctor about whether it is safe to drive if you:
- have frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia
Humalog Junior KwikPen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say it is essentially “sodium-free”.
3. How to use Humalog Junior KwikPen
Always use this medicine exactly as your doctor has told you. If you have any doubts, you should
consult your doctor. To prevent possible transmission of diseases, each pen should be
used by only one patient, even if the needle is changed.
Dose
- The number of half units (0.5 units) is visible in the dose window of the pen. Half units (0.5 units) are indicated as lines between the numbers.
- Always check the number shown in the dose window to make sure you have selected the correct dose.
- Normally, you should inject Humalog within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding quantity, timing and frequency of administration, follow your doctor's instructions exactly; they apply only to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medication (more or
less) than before. The change may occur with the first injection, or may
be carried out gradually over a period of weeks or months.
- Humalog KwikPen is only suitable for subcutaneous injections. Talk to your doctor if you need to inject insulin in another way.
Preparation of Humalog Junior KwikPen
- Humalog is already dissolved in water, so you do not need to mix it. However, be careful to use it onlyif its appearance is the same as that of water. The solution must be clear, colorless and free of solid particles. Check all of this before each injection.
Preparation of the Junior KwikPen to make it ready for use (see the instruction manual
for use)
- First, wash your hands.
- Read the instructions on how to use your prefilled insulin pen and follow them carefully. Below are some important points.
- Always use a new needle (needles are not included in the package).
- Load the Junior KwikPen every time before use. This allows you to check that insulin is flowing out and to eliminate any air bubbles from the Junior KwikPen. Some small air bubbles may have remained in the pen; they are not dangerous, but if they are too large they may make the insulin dose to be injected less accurate.
Injection of Humalog
- Before making the injection, disinfect the skin according to the instructions you have received. Inject the medicine subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to make sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used last time and remember to rotate the injection site, as you have been told. It doesn't matter which injection site you use, whether it's the upper arms, thighs, buttocks, or abdomen, the injection of Humalog will have an even faster action than soluble human insulin.
- You should not administer Humalog intravenously. Inject Humalog as your doctor or nurse has taught you. Only the doctor can administer Humalog intravenously. This will only be done in special circumstances such as surgery or if you are ill and your blood sugar levels are too high.
After the injection
- As soon as you have finished the injection, remove the needle from the Junior KwikPen using the outer cap of the needle. This will allow you to keep the insulin sterile, prevent leakage of the medicine, stop air from entering the pen and prevent the needle from becoming blocked. Do not share your needles with others. Do not share your pen with others. Reposition the cap on the pen.
Subsequent injections
- Each time you use the Junior KwikPen you must use a new needle. Before each injection, eliminate any air bubbles. You can check how much insulin is left in the Junior KwikPen by holding it vertically, with the needle pointing upwards. The graduation on the cartridge will indicate approximately the remaining units.
- Once the Junior KwikPen is empty, do not reuse it. Dispose of it carefully. Your pharmacist, or the staff at the diabetes center will tell you how to do it.
Use of Humalog in microinfusors
- The Junior KwikPen is only suitable for injections made under the skin. Do not use the pen to administer Humalog in a different way. If this is necessary, other formulations of Humalog 100 units/ml are available. Talk to your doctor if this applies to you.
If you use more Humalog than you should
If you use more Humalog than you should or are not sure how much you have injected, a
decrease in blood sugar levels may occur. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia), eat glucose tablets,
sugar or take a sugary drink. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and your breathing is short
and your skin turns pale, inform your doctor immediately. A glucagon injection can treat
fairly severe hypoglycemias. Take glucose or sugar after the glucagon injection. If you
do not get a positive response with glucagon, you must be hospitalized. Ask your doctor
for information on the use of glucagon.
If you forget to use Humalog
If you take less Humalog than you need or are not sure how much you have injected, an
increase in blood sugar levels may occur. Check your blood sugar level.
Untreated hypoglycemias (low blood sugar level) or hyperglycemias (high blood sugar level)
can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death (see section 4 “Possible side
effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always carry a spare pen with you, in case you lose the Junior KwikPen or it is damaged.
- Always carry a document proving that you are diabetic.
- Always carry sugar with you.
If you stop treatment with Humalog
If you take less Humalog than you need, an increase in blood sugar levels may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Severe allergy is rare (may affect up to 1 in 1,000 people). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
low blood pressure
fast heartbeat
sweating
If you believe that Humalog is causing you this type of insulin allergy, immediately inform
a doctor.
Local allergy is common (may affect up to 1 in 10 people). In some people, the skin in the area
around the injection site may appear red, swollen and itchy. Usually, this
reaction disappears within a few days or weeks. If this occurs, inform your doctor.
Lipodystrophy is uncommon (may affect up to 1 in 100 people). If you inject insulin too
often in the same place, the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy).
Nodules under the skin can also be caused by the accumulation of a protein called
amyloid (cutaneous amyloidosis). Insulin may not work as well as it should if you inject
in an area with nodules. Change the injection site with each injection to prevent these
skin changes.
Edema has been reported (e.g., swelling of the arms, ankles; fluid retention), in
particular at the beginning of insulin therapy or during a modification of therapy to improve
blood sugar level control.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the
national reporting system reported in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.
Common problems of diabetes
Hypoglycemia
Hypoglycemia (low blood sugar) means that there is not enough sugar in the
blood. Hypoglycemia can be caused by:
- an excessive dose of Humalog or another insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work performed immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in insulin requirements;
- worsening of pre-existing kidney or liver disease.
Alcohol and some medicines can interfere with your blood sugar level (see
paragraph 2).
Usually, the first symptoms of hypoglycemia occur quickly and include:
tiredness
nervousness or agitation
headache
fast heartbeat
feeling unwell
cold sweat
If you are unable to recognize the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.
Hyperglycemia and diabetic ketoacidosis
Hyperglycemia (too much sugar in the blood) means that there is not enough
insulin in your body. Hyperglycemia can be caused by:
- failure to take Humalog or another insulin;
- taking a dose of insulin lower than prescribed by your doctor;
- eating a much larger amount of food than allowed by your diet; or
- fever, infection or strong emotion.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms develop slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical
attention.
Illness
If you have an illness, especially if you feel unwell or are sick, your insulin needs may change.
Even when you are not eating normally, you still need insulin.Check
your urine and blood for sugar; when you are sick, follow the precautions you already know and inform
your doctor.
5. How to store Humalog Junior KwikPen
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging. The
expiry date refers to the last day of the month.
Before first use store Humalog Junior KwikPen in a refrigerator (2°C - 8°C). Do not freeze.
During use store Humalog Junior KwikPen at room temperature (below 30°C) and
discard it after 28 days even if some of the solution remains. Do not keep the product near a
heat source or in direct sunlight. Do not store the Junior KwikPen that you are
using in the refrigerator. The Junior KwikPen must not be stored with the needle inserted.
Do not use this medicine if you notice that the solution is coloured or contains solid particles. You must
use it onlyif its appearance is the same as that of water. Check all of this before each
injection.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What Humalog 100 units/ml Junior KwikPen injectable solution contains
- The active substance is insulin lispro. Each ml of solution contains 100 units (U) of insulin lispro. Each pre-filled pen (3 ml) contains 300 units (U) of insulin lispro.
- The excipients are metacresol, glycerol, dibasic sodium phosphate 7H O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH.
Description of the appearance of Humalog 100 units/ml Junior KwikPen and contents of the pack
Humalog 100 units/ml Junior KwikPen injectable solution is a sterile, clear, aqueous solution,
colourless and contains 100 units of insulin lispro per millilitre (100 units/ml) of injectable
solution. Each Humalog Junior KwikPen contains 300 units (3 millilitres). Humalog Junior KwikPen
is available in packs of 1 or 5 pre-filled pens or in a multi-pack of 2 packs of
5 pre-filled pens. Not all pack sizes may be marketed. The Junior
KwikPen simply has an integrated cartridge. When the pre-filled pen is empty, you cannot
reuse it. The Junior KwikPen is blue in colour. The dose selector button is blue with
raised markings. The label is white with an orange strip and features a burgundy (plum), yellow and orange band. Each Junior KwikPen delivers from 0.5 to 30 units in
increments of 0.5 units at a time.
Marketing Authorisation Holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
Manufacturer
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Ели Лили Недерланд" Б.В. - България
tel. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
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ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
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Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
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Lilly S.A.
Tel: + 34-91 663 50 00
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Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
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Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
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Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
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Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
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Eli Lilly România S.R.L.
Tel: + 40 21 4023000
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Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
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Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
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Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
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Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
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Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
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Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
INSTRUCTIONS FOR USE
The text of the instructions for use is reported below.
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/ .
Instructions for use
Humalog 100 units/ml Junior KwikPen injectable solution in a prefilled pen
insulin lispro
READ THESE INSTRUCTIONS BEFORE USE
Read the instructions for use before using Humalog Junior KwikPen and each time you need to
use Humalog Junior KwikPen again. There may be new information. This
information does not replace consultation with healthcare professionals regarding your medical condition or
treatment.
Humalog 100 units/ml Junior KwikPen (“Pen”) is a disposable prefilled pen containing 3 ml
(300 units, 100 units/ml) of insulin lispro injectable solution. One Pen contains multiple doses of
insulin.
- Healthcare professionals will tell you how many units of insulin to administer and how to inject the prescribed dose of insulin.
- The Pen allows you to select half a unit (0.5 units) at a time. You can administer from 0.5 units to 30 units in a single injection.
- Always check the number indicated in the dosage window to be sure you have selected the correct dose.
- If your dose is greater than 30 units, you will need to administer more than one injection.
- The plunger moves only slightly with each injection and you may not notice the movement. When the plunger reaches the end of the cartridge, it means you have used all 300 units in the Pen.
Do not share your Pen with other people, even if the needle has been changed. Do not reuse needles and do not share them with other people. This could cause an infection to the person you lent it to or
catch an infection from the person who lent it to you.
This Pen should not be used by the blind or those with visual impairments without
the assistance of a person trained to use the Pen.
Components of Humalog Junior KwikPen
Dose indicator
Components of the Pen needleDose selector button
Blue, with raised lines
on the bottom and side
(needles are not included)
Paper protection
Outer cap
of the needle
Inner cap
of the needle
Needle
How to recognize the Humalog Junior KwikPen:
- Pen color: Blue
- Color of the dose selector button: Blue, with raised lines on the bottom and side
- Label: White with an orange stripe and a burgundy (plum), yellow and orange band.
Materials needed to administer the dose:
- Humalog Junior KwikPen
- Needle compatible with the KwikPen (BD [Becton, Dickinson and Company] pen needles are recommended)
- Disinfectant swab. Needles and disinfectant swab are not included.
Preparing the Pen
- Wash your hands with soap and water.
- Check the Pen to make sure you are taking the correct type of insulin. This is particularly important if you use more than 1 type of insulin.
- Do notuse the Pen after the expiration date printed on the label or for more than 28 days from when you started using the Pen.
- Always use a new needlefor each injection. This helps prevent infections and needle blockages.
Step 1:
- Remove the cap from the Pen.
- Do notremove the Pen label.
- Clean the rubber closure with a disinfectant swab.
Humalog should appear clear and colorless. Do not use it
if it appears cloudy, colored, or if it contains particles
or clumps.
Step 2:
- Choose a new needle.
- Remove the paper protection from the outer cap of the needle.
Step 3:
- Insert the needle, covered by the cap, straight onto the end of the Pen and rotate the needle until it is firmly attached.
Step 4:
- Remove the outer cap of the needle. Do notthrow it away.
- Remove the inner cap of the needle and throw it away.
Priming the Pen
Prime the Pen before each injection.
- Priming the Pen means removing air from the needle or cartridge that may form during normal use. It is important to prime the Pen so that it works correctly.
- If you do notprime it before each injection, you may inject too much or too little insulin.
Step 5:
- To prime the Pen, select 2 units by rotating the dose selector button.
Step 6:
- Hold the Pen with the needle pointing upwards. Gently tap the cartridge to collect air bubbles on the surface.
Step 7:
- Continue to hold the Pen with the needle pointing upwards. Press the dose selector button until it stops, and a “0” appears in the dosage window. Keep the dose selector button pressed and count slowlyto 5.
You should see insulin at the tip
of the needle.
- If insulin does notappear, repeat the priming operations, but no more than 4 times.
- If insulin still does notappear, change the needle and repeat the priming operations. Small air bubbles are normal and do not interfere with the dosage.
Selecting the dose
- You can administer from half a unit (0.5 units) to 30 units in a single injection. Always check the number in the dosage window to make sure you haveselected the correct dose.
- If the dose is greater than 30 units, you will need to administer more than one injection.
- Ask healthcare professionals how to inject the dose.
- You must use a new needle for each new injection and repeat the priming operation.
- If your insulin requirement is usuallygreater than 30 units, ask healthcare professionals if another Humalog KwikPen may be better for you
Step 8:
- Rotate the dose selector button to the number of units to be injected. The dose indicator must be aligned with the dose.
- The Pen allows you to select half a unit (0.5 units) at a time.
- The dose selector button clicks when you rotate it.
Example: 4 units
shown in the
dosage window
- Do notselect the dose by counting the number of clicks because you may select the wrong dose.
- The dose can be corrected by rotating the dose selector button in any direction until the correct dose is aligned with the dose indicator.
Example: 10 units and
a half (10.5) shown
in the dosage
window
- The numbers corresponding to whole unitsare printed on the dial.
- Half unitsare displayed as lines between the numbers.
- Always check the number in the dosage window to make sure you have selected thecorrect dose.
- The Pen will not allow you to select more units than are available in the Pen.
- If you need to administer more units than are available in the pen, you can:
- administer the remaining amount in the Pen and then use a new Pen to add the rest of the dose, or
- take a new Pen and administer the full dose.
- It is normal to see a small amount of insulin remaining in the Pen that cannot be injected.
Injecting the dose
- Inject the insulin as healthcare professionals have shown you.
- Change (rotate) the injection site for each injection.
- Do nottry to change the dose while administering the injection.
Step 9:
- Choose the injection site. Humalog is injected under the skin (subcutaneous injection) of the abdominal area, buttocks, thighs, or upper arms.
- Clean the skin with a disinfectant swab and wait for the skin to dry before injecting the dose.
Step 10:
- Insert the needle into the skin.
- Press the dose selector button all the way down.
- Continue to hold the dose selector button pressed and count slowlyto 5before removing the needle. 5 sec
Do nottry to inject insulin
by rotating the dose selector button.
Rotating the dose selector button
Will notreceive your dose of insulin.
Step 11:
- Remove the needle from the skin.
- A drop of insulin remaining on the tip of the needle is normal. It will not affect the administered dose.
- Check the number that appears in the dosage window.
- If you see “0” in the dosage window, it means you have administered the entire selected dose.
- If you do not see “0” in the dosage window, it means you have not administered the entire dose. Do notreselect the dose. Insert the needle into the skin and finish your injection.
- If you think you have still notreceived the entire dose you selected for the injection, do notrestart or repeat the injection. Check your blood glucose level and contact healthcare professionals for further instructions. The plunger moves only slightly with each injection and you may not notice the movement. If you see blood after removing the needle from the skin, gently press on the injection site with a gauze or disinfectant swab. Do notrub the affected area.
After the injection
Step 12:
- Carefully replace the cap on the needle.
Step 13:
- Unscrew the needle covered by the cap and dispose of it as described below (see the Disposing of the Pen and needlessection).
- Do not store the Pen with the needle inserted to prevent leaks, needle blockage and air from entering the Pen.
Step 14:
- Reposition the cap on the Pen holding it with the cap clip aligned with the dose indicator and press straight onto the Pen.
Disposal of the Pen and Needles
- Place used needles in a closable container specifically for sharp or hard plastic waste with a secure lid. Donot discard needles directly into household waste containers.
- Donot recycle the container once it is filled with needles.
- Ask healthcare professionals about available options for appropriate disposal of the Pen and the container.
- Instructions regarding needle handling should not replace local institutional or healthcare personnel regulations.
Instructions for Pen Storage
Unused Pens
- Store unused Pens in the refrigerator at a temperature between 2°C and 8°C.
- Donot freeze Humalog. Donot use it if it has been frozen.
- Unused Pens can be used up to the expiration date printed on the label, if the Pen has been stored in the refrigerator.
Pen in Use
- Store the Pen you are currently using at room temperature (below 30°C) and protected from dust, food and liquids, heat and light.
- Discard the Pen you are using after 28 days have passed, even if it still contains insulin inside.
General Safety Information and Effective Use of the Pen
- Keep the Pen and needles out of the sight and reach of children.
- Donot use the Pen if any part of it appears broken or damaged.
- Always carry an extra Pen with you in case you lose or damage it.
Troubleshooting
- If you cannot remove the Pen cap, gently rotate it back and forth, and then pull it off.
- If you have difficulty pushing the dose selector button:
- Pushing the dose selector button more slowly may make injection easier.
- The needle may be blocked. Insert a new needle and prime the Pen.
- There may be dust, food, or liquids inside the Pen. Discard the Pen and take a new one. You may need to request a prescription from your doctor.
For further information or if you have problems with Humalog 100 units/ml Junior KwikPen, contact your
healthcare professional for assistance or contact your local Eli Lilly branch.
Document revision date:
Humalog 100 units/ml Tempo Pen injectable solution in a prefilled pen
insulin lispro
Each prefilled pen delivers from 1 to 60 units in 1-unit increments.
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Humalog Tempo Pen is and what it is used for
- 2. What you need to know before you use Humalog Tempo Pen
- 3. How to use Humalog Tempo Pen
- 4. Possible side effects
- 5. How to store Humalog Tempo Pen
- 6. Contents of the pack and other information
1. What is Humalog Tempo Pen and what is it used for
Humalog Tempo Pen is used for the therapy of diabetes. Humalog acts more quickly
than normal human insulin, thanks to a small modification of the insulin molecule. Insulin
lispro is structurally similar to human insulin, which is a natural hormone produced by the pancreas.
Your condition, diabetes, stems from the fact that your pancreas does not produce insulin in sufficient
quantity to control blood glucose levels. Humalog replaces the insulin produced by your
body and is used to control glucose in the long term. The medicine acts very
quickly and lasts for a shorter period of time compared to a soluble insulin (from 2 to 5 hours). You should
normally inject Humalog within 15 minutes before a meal.
The doctor may prescribe both the use of Humalog Tempo Pen and a long-acting insulin.
correct use. Do not change the type of insulin unless prescribed by your doctor.
The use of Humalog is suitable for both adults and children.
The Tempo Pen is a disposable pre-filled pen device containing 3 ml (300 units,
100 units/ml) of insulin lispro. One Tempo Pen contains multiple doses of insulin. The Tempo Pen
allows you to select 1 unit at a time. The number of units is visible in the dosage window,
always check it before the injection.You can administer from 1 to 60 units in a single
injection. If the dose is greater than 60 units, you will need to administer more than one injection.
2. What you need to know before using Humalog Tempo Pen
DO NOT use Humalog Tempo Pen
- If you believe you are experiencing hypoglycemia(low blood sugar). Further instructions on how to manage mild hypoglycemia can be found later in this leaflet (see section 3: If you use more Humalog than you should).
- If you are allergicto insulin lispro or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- Always check the packaging and the label of the prefilled pen to ensure the name and type of insulin you receive from the pharmacist is correct. Make sure your Humalog 100 units/ml Tempo Pen packaging matches what your doctor has prescribed.
- If your blood glucose level is well controlled with your current insulin therapy, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet in section 4. You must pay close attention to the timing of meals, the frequency and intensity of exercise. You should also monitor your blood sugar level frequently by measuring it.
- Some people who switched from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, tell your doctor, pharmacist or diabetes center nurse.
- Have you been ill recently?
- Do you have problems with your liver or kidneys?
- Are you doing more exercise than usual?
- The amount of insulin you need may also change if you drink alcohol.
- Also, inform your doctor, pharmacist or diabetes center nurse if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
- Some patients with long-standing type 2 diabetes and heart disease or a previous cerebrovascular event who were treated with pioglitazone and insulin have reported the development of heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
- This Pen should not be used by the visually impaired or those with poor eyesight without the assistance of people trained to use the Pen.
- The Tempo Pen contains a magnet. If you have an implanted medical device, such as a pacemaker, it may not function properly if the Tempo Pen is held too close. The magnetic field extends approximately 1.5 cm.
Skin changes at the injection site
The injection site must be rotated to prevent skin changes, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject into
an area with lumps (see section How to use Humalog Tempo Pen). If you are currently
injecting into an area with lumps, consult your doctor before starting to inject into
another area. Your doctor may advise you to check your blood sugar more carefully and adjust
the dose of insulin or other antidiabetic medicines.
Other medicines and Humalog Tempo Pen
Your insulin needs may change if you are taking
- the birth control pill,
- corticosteroids,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- “beta2-agonists” (e.g. ritodrine, salbutamol or terbutaline),
- beta-blockers or
- some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) and
- angiotensin II receptor blockers.
Tell your doctor if you are taking, have recently taken or may take any other
medicines, including over-the-counter medicines (see section “Warnings and
precautions”).
Humalog with alcohol
Drinking alcohol can raise or lower your blood sugar level. For this reason
the amount of insulin you need may change.
Pregnancy and breastfeeding
Are you pregnant, planning to become pregnant, or breastfeeding? Insulin requirements
generally decrease during the first trimester of pregnancy and increase in the following six months. If
you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet.
Ask your doctor for advice.
Driving and using machines
Your ability to concentrate and react may be impaired if you experience hypoglycemia.
Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using machinery). You should consult your doctor
about whether it is safe to drive if you:
- experience frequent episodes of hypoglycemia
- have reduced or absent warning signs of hypoglycemia
Humalog Tempo Pen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially “sodium-free”.
3. How to use Humalog Tempo Pen
Always use this medicine exactly as your doctor has told you. If you have any doubts, you should
consult your doctor. To prevent possible transmission of diseases, each pen must be
used only by you, even if the needle is changed.
Dose
- Always check the number indicated in the dosage window to be sure you have selected the correct dose.
- Normally, you should inject Humalog within 15 minutes before a meal. If necessary, you can also inject it immediately after the meal. Regarding quantity, timing and frequency of administration, follow your doctor's instructions exactly. These apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
- Humalog Tempo Pen is only suitable for subcutaneous injections. Talk to your doctor if you need to inject insulin in another way.
Preparation of Humalog Tempo Pen
- Humalog is already dissolved in water, so you do not need to mix it. However, be careful to use it onlyif its appearance is the same as that of water. The solution must be clear, colorless and free of solid particles. Check all of this before each injection.
Preparation of the Tempo Pen to make it ready for use (see the instruction manual for
use)
- First, wash your hands.
- Read the instructions on how to use your prefilled insulin pen. Follow them scrupulously. The following are some important points.
- Always use a new needle (needles are not included in the package).
- Load the Tempo Pen every time before use. This allows you to check that insulin is flowing out and to eliminate any air bubbles from the Tempo Pen. Some small air bubbles may have remained in the pen; they are not dangerous, but if they are too large, they may make the insulin dose to be injected less accurate.
Injection of Humalog
- Before giving the injection, disinfect the skin according to the instructions you have received. Inject the medicine subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for five seconds to be sure you have injected the entire dose. Do not rub the area where you made the injection. Make sure the injection site is at least one centimeter away from the one used previously and remember to rotate the injection site, as you have been told. It does not matter which injection site you use, whether it is the upper arm, thigh, buttocks or abdomen, the injection of Humalog will have an even faster action than soluble human insulin.
- You should not administer Humalog intravenously. Inject Humalog as your doctor or nurse has taught you. Only the doctor can administer Humalog intravenously. This will only be done in specific circumstances such as surgery or if you are ill and your levels of
After the injection
- As soon as you have finished the injection, remove the needle from the Tempo Pen using the outer cap of the needle. This will allow you to keep the insulin sterile and avoid leakage of the medicine. It also stops air from entering the pen and prevents the needle from becoming clogged. Do not share your needles with others. Do not share your pen with others. Reposition the cap on the pen.
If you are not sure how much insulin you have injected, check your blood sugar levels before
deciding if you need another injection.
Subsequent injections
- Each time you use the Tempo Pen you must use a new needle. Before each injection, eliminate any air bubbles. You can check how much insulin is left in the Tempo Pen by holding it vertically, with the needle pointing upwards. The graduation on the cartridge will indicate approximately the remaining units. DO NOT mix Humalog 100 units/ml injectable solution in the prefilled pen with any other insulin or with any other medicine.
- Once the Tempo Pen is empty, do not reuse it. Dispose of it carefully. Your pharmacist, or the staff at the diabetes center will tell you how to do this.
Tempo Smart Button
The Tempo Pen is designed to work with the Tempo Smart Button. The optional Tempo Smart Button is a product available for the Tempo Pen, which can be used
to transmit dose information to a mobile application. The Tempo Pen can be used
with or without the Tempo Smart Button connected. For more information see the instructions provided
with the Tempo Smart Button and the mobile application.
Use of Humalog in microinfusors
- The Tempo Pen is only suitable for injections made under the skin. Do not use the pen to administer Humalog in a different way. If this is necessary, other formulations of Humalog 100 units/ml are available. Talk to your doctor if this concerns you.
If you use more Humalog than you should
If you use more Humalog than you should or are not sure how much you have injected, a
decrease in blood sugar level may occur. Check your blood sugar level.
If your blood sugar level is low (mild hypoglycemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and your breathing is short and your skin is turning pale, inform your doctor immediately. A glucagon injection can treat quite severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you do not get a positive response with glucagon, you must be hospitalized. Ask your doctor for information on the use of glucagon.
If you forget to use Humalog
If you take less Humalog than you need or are not sure how much you have injected, an
increase in blood sugar level may occur. Check your blood sugar level.
Untreated hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) can become very serious and cause headache, feeling unwell (nausea), feeling sick (vomiting), loss of fluids (dehydration), loss of consciousness, coma and even
death (see section 4 “Possible side effects”).
Three simple precautionsto avoid situations of hypoglycemia or hyperglycemia:
- Always carry a spare pen with you, in case you lose the Tempo Pen or it becomes damaged.
- Always carry a document with you proving that you are diabetic.
- Always carry sugar with you.
If you stop treatment with Humalog
If you use less Humalog than you need, an increase in blood sugar level may occur.
Do not change the type of insulin unless prescribed by a doctor.
If you have any doubts about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergy is rare (may affect up to 1 in 1,000 people). The symptoms are:
rash all over the body
difficulty breathing
shortness of breath
low blood pressure
fast heartbeat
sweating
If you believe that Humalog is causing you this type of insulin allergy, immediately inform
a doctor.
Local allergy is common (may affect up to 1 in 10 people). In some people, the skin in the area
around the injection site may appear red, swollen and itchy. Usually, this
reaction disappears within a few days or weeks. If this occurs, inform your doctor.
Lipodystrophy is uncommon (may affect up to 1 in 100 people). If you inject insulin too
often in the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy).
Lumps under the skin can also be caused by the build-up of a protein called amyloid
(cutaneous amyloidosis). Insulin may not work as well as it should if you inject into
an area with lumps. Change the injection site with each injection to prevent these changes in
the skin.
Edema has been reported (e.g. swelling of the arms, ankles; fluid retention), in
particular at the beginning of insulin therapy or during a change in therapy to improve
blood sugar level control.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system listed in Annex V .
By reporting side effects you can help provide more information on the safety
of this medicine.
Common diabetes problems
- A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
- too much Humalog or other insulin;
- delaying or missing a meal, or a change in diet;
- excessive physical activity or exertion immediately before or after a meal;
- an infection or other illness (especially diarrhea or vomiting);
- a change in your insulin needs; or
- worsening of pre-existing kidney or liver problems.
Alcohol and some medicines can interfere with your blood sugar level (see
paragraph 2).
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or agitation
headache
fast heartbeat
feeling unwell
cold sweat
If you are unable to recognise the warning symptoms of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.
- B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
- not taking enough Humalog or other insulin;
- taking a dose of insulin lower than prescribed by your doctor;
- eating much more food than allowed by your diet; or
- fever, infection or a severe emotional upset.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling or being sick
Heavy, rapid breathing and fast pulse are serious symptoms. Seek immediate
medical attention.
- C.IllnessIf you have an illness, especially if you feel unwell or are sick, your insulin needs may change. Even when you are not eating normally, you still need insulin.Test your urine and blood; when you are ill, follow the precautions you already know and inform your doctor.
5. How to store Humalog Tempo Pen
Before first use, store Humalog Tempo Pen in a refrigerator (2°C - 8°C). Do not freeze.
During use, store Humalog Tempo Pen at room temperature (below 30°C) and
discard it after 28 days even if some of the solution remains. Do not keep the product near a
heat source or in direct sunlight. Do not store the Tempo Pen you are using in the refrigerator. The
Tempo Pen should not be stored with the needle inserted.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging. The
expiry date refers to the last day of the month.
Do not use this medicine if you notice that the solution is coloured or contains solid particles. You must
only use it if its appearance is the same as water. Check all of this before each
injection.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Humalog 100 units/ml Tempo Pen injectable solution contains
- The active ingredient is insulin lispro. Each ml of solution contains 100 units (U) of insulin lispro. Each pre-filled pen (3 ml) contains 300 units (U) of insulin lispro.
- The excipients are metacresol, glycerol, dibasic sodium phosphate 7H O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH.
Description of Humalog Tempo Pen appearance and package contents
Humalog 100 units/ml Tempo Pen injectable solution is a sterile, clear, colorless aqueous solution
containing 100 units of insulin lispro per milliliter (100 units/ml) of injectable solution.
Each Humalog Tempo Pen contains 300 units (3 milliliters). Humalog Tempo Pen is
available in packs of 5 pre-filled pens or in a multi-pack of 2 packs of 5
pre-filled pens. Not all pack sizes may be marketed. Humalog 100
units/ml contained in the pre-filled pen is the same Humalog 100 units/ml contained in the cartridges
of Humalog 100 units/ml sold separately. The pre-filled pen simply has an integrated cartridge.
When the pre-filled pen is empty, it cannot be reused. The Tempo Pen contains a magnet
(see section 2 “Warnings and precautions”).
Marketing authorisation holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.
Manufacturer
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.
Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
TP "Ели Лили Недерланд" Б.В. - България
тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 6000
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges. m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France S.A.S.
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0) 1 580 00 10
Ísland
Icepharma hf.
Sími + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Tel: + 39- 055 42571
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse)S.A. Pārstāvniecība Latvijā
Tel: +371 67364000
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/ .
Instructions for use
Humalog 100 units/ml Tempo Pen injectable solution in a prefilled pen
insulin lispro
READ THESE INSTRUCTIONS BEFORE USE
Read the Instruction Manual before using the insulin and every time you need to use another
Humalog Tempo Pen. There may be new information. This information does not replace
discussion with healthcare professionals regarding your medical condition or treatment.
Tempo Pen (“Pen”) is a disposable prefilled pen containing 3 ml (300 units, 100 units/ml) of
insulin. You can administer multiple doses using a single pen. The Pen allows you to
select 1 unit at a time. You can administer from 1 to 60 units in a single injection. If your
dose is greater than 60 units, you will need to administer more than one injection.The plunger will
move only slightly with each injection and you may not notice the movement. The plunger
will reach the end of the cartridge only when you have used all 300 units in the Pen.
The Tempo Pen is designed to work with the Tempo Smart Button. The Tempo Smart Button is an
optional product that can be attached to the dose selector button of the Tempo Pen and helps to
transmit the Humalog dose information from the Tempo Pen to a compatible mobile application.
The Tempo Pen injects insulin with or without the Tempo Smart Button attached. The Smart
Button must be connected to a Tempo Pen to record or transfer dose-related data. Push the Smart Button straight down onto the dose selector button until you hear a
click or feel the Smart Button snap into place. To transmit data to the mobile
application, follow the instructions provided with the Tempo Smart Button and the instructions provided with
the mobile application.
Do not share your Pen with other people, even if the needle has been changed. Do not reuse needles and do not share them with other people. You could cause an infection to the person you lent it to or get an infection from the person you borrowed it from.
This Pen should not be used by the visually impaired or those with visual difficulties without
the assistance of people trained to use the Pen.
Components of the Tempo Pen
Dose selector
button
How to recognize the Tempo Pen:
- Pen color: blue
- Dose selector button: burgundy (plum) red
- Label: white with a burgundy (plum) red stripe Materials needed to administer the dose:
- Tempo Pen containing the insulin
- Needle compatible with the Tempo Pen (BD [Becton, Dickinson and Company] pen needles are recommended)
- Alcohol swab Needles and alcohol swabs are not included. Preparing the Pen
- Wash your hands with soap and water.
- Check the Pen to make sure you are taking the correct type of insulin. This is particularly important if you use more than 1 type of insulin.
- Do notuse the Pen after the expiration date printed on the label. After you have started using the
- Always use a new needlefor each injection to help prevent infections and needle blockages.
Step 1:
- Remove the Pen cap.
- Do notremove the Pen label.
- Clean the rubber closure with an alcohol swab. HUMALOG should appear clear and colorless. Do not use it if it appears cloudy, colored, or if it contains particles.
Step 2:
- Choose a new needle.
- Remove the paper protection from the outer cap of the needle.
Step 3:
- Insert the needle covered by the cap straight onto the end of the Pen and rotate the needle until it is firmly attached.
Step 4:
- Remove the outer cap of the needle. Do notthrow it away.
- Remove the inner cap of the needle and throw it away.
Priming the Pen
Prime the Pen before each injection.
- Priming the Pen means removing air from the needle and cartridge that may form during normal use and ensures that the Pen is working correctly.
- If you do notprime before each injection, you may inject too much or too little insulin.
Step 5:
- To prime the Pen, select 2 units by rotating the dose selector button.
Step 6:
- Hold the Pen with the needle pointing upwards. Gently tap the cartridge to collect the air on the surface.
Step 7:
- Continue to hold the Pen with the needle pointing upwards. Press the dose selector button until it stops, and a “0” appears in the dosage window. Keep the dose selector button pressed and count slowly to 5.
5 sec
Do nottry to inject the insulin by rotating the
dose selector button. Rotating the dose selector button will notdeliver your dose of
insulin.
Step 8:
- Extract the needle from the skin.
- A drop of insulin remaining on the tip of the needle is normal. It will not affect the dose administered.
- Check the number in the dosage window
- If the dosage window shows “0”, it means you have administered the entire selected dose.
- If you do not see “0” in the dosage window, do not reselect the dose. Insert the needle into the skin and finish your injection.
- If you think you have not yetreceived the entire amount you selected for the injection, do not restart or repeatthe injection. Check your blood glucose level as directed by your healthcare professional.
- If you normally need 2 injections to administer the entire dose, make sure to perform the second injection. The plunger moves slightly with each injection and you may not notice the movement. If you see blood after removing the needle from the skin, gently press on the injection site with gauze or an alcohol swab. Do notrub the affected area.
After the injection
Step 12:
- Carefully replace the outer cap on the needle.
Step 13:
- Unscrew the needle covered by the cap and dispose of it as described below (see the Disposing of the Pen and Needlessection).
- Do not store the Pen with the needle inserted to prevent leakage, needle blockage and air from entering the Pen.
Step 14:
- Reposition the cap on the Pen holding it with the cap clip aligned with the dose indicator and press straight onto the Pen.
Disposal of the Pen and Needles
- Place used needles in a suitable closable container for sharp or hard plastic waste with a secure lid. Do notthrow needles directly into the household waste container.
- Do notrecycle the container once it is filled with needles.
- Ask healthcare professionals about available options for proper disposal of the pens and this container.
- Instructions regarding needle handling should not replace local, institutional, or healthcare professional regulations. Instructions for Pen StorageUnused Pens
- Store unused Pens in the refrigerator at a temperature between 2°C and 8°C.
- Do notfreeze the insulin. Do notuse it if it has been frozen.
- Unused Pens can be used up to the expiration date printed on the label, if the Pen has been stored in the refrigerator. Pen in Use
- Store the Pen you are currently using at room temperature (below 30°C) and protected from dust, food and liquids, heat and light.
still contains insulin inside.
General Safety Information and Effective Use of the Pen
- Keep the Pen and needles out of the sight and reach of children.
- Do notuse the Pen if any part of it appears broken or damaged.
- Always carry an extra Pen with you in case it is lost or damaged. Troubleshooting
- If you cannot remove the Pen cap, gently rotate it back and forth, and then pull it off.
- If you have difficulty pushing the dose selector button:
- Pushing the dose selector button more slowly may make injection easier.
- The needle may be blocked. Insert a new needle and prime the Pen.
- There may be dust, food or liquids inside the Pen. Discard the Pen and take a new one. You may need to request a prescription from your doctor.
For further information or if you have problems with the Tempo Pen, contact healthcare professionals for
assistance or contact your local Eli Lilly branch.
Document revision date:
- Страна регистрации
- Форма выпускаInjectable solution, 100 U/ML
- Код АТХA10AB04
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги UMALOGФорма выпуска: Injectable solution, 100 U/MLДействующее вещество: инсулин лиспроПроизводитель: SANOFI WINTHROP INDUSTRIEОтпускается по рецептуФорма выпуска: Injectable solution, 100 U/MLДействующее вещество: инсулин лиспроПроизводитель: ELI LILLY NEDERLAND B.V.Отпускается по рецептуФорма выпуска: Injectable solution, 40 IU/MLДействующее вещество: инсулин человекаПроизводитель: NOVO NORDISK A/SОтпускается по рецепту
Аналоги UMALOG в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог UMALOG в Испания
Аналог UMALOG в Украина
Врачи онлайн по UMALOG
Обсудите применение UMALOG и возможные следующие шаги — по оценке врача.
Получите рецепт на UMALOG онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
UMALOG требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество UMALOG — инсулин лиспро. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
UMALOG производится компанией ELI LILLY NEDERLAND B.V.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения UMALOG с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить UMALOG в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (инсулин лиспро) включают INSULINA LISPRO SANOFI, LYUMJEV, AKTRAPID. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
