LYUMJEV 100 U/ML Roztwór do wstrzykiwań

Anna Biriukova

Lek. Anna Biriukova jest specjalistą chorób wewnętrznych (internistą) z doświadczeniem w kardiologii, endokrynologii i gastroenterologii. Oferuje konsultacje online dla dorosłych, zapewniając kompleksową opiekę nad zdrowiem serca, układu hormonalnego, trawiennego oraz ogólnym stanem zdrowia.

Kardiologia – diagnostyka i leczenie:

Nadciśnienie tętnicze, wahania ciśnienia i profilaktyka powikłań sercowo-naczyniowych.
Bóle w klatce piersiowej, duszność, arytmie (tachykardia, bradykardia, kołatania serca).
Obrzęki kończyn, przewlekłe zmęczenie, spadek tolerancji wysiłku.
Interpretacja EKG, ocena profilu lipidowego, analiza ryzyka zawału i udaru.
Opieka kardiologiczna po COVID-19.

Endokrynologia – cukrzyca, tarczyca, metabolizm:

Rozpoznawanie i leczenie cukrzycy typu 1 i 2, stanu przedcukrzycowego.
Indywidualnie dobrane plany terapii z wykorzystaniem leków doustnych i insulinoterapii.
Leczenie GLP-1 – nowoczesna farmakoterapia wspierająca redukcję masy ciała i kontrolę cukrzycy, w tym dobór preparatów, monitorowanie efektów i bezpieczeństwa.
Zaburzenia tarczycy – niedoczynność, nadczynność, choroby autoimmunologiczne (Hashimoto, Graves-Basedow).
Metabolic syndrome – otyłość, zaburzenia lipidowe, insulinooporność.

Gastroenterologia – układ pokarmowy:

Bóle brzucha, nudności, zgaga i refluks żołądkowo-przełykowy (GERD).
Choroby żołądka i jelit: zapalenie błony śluzowej żołądka, zespół jelita drażliwego (IBS), niestrawność.
Kontrola przewlekłych schorzeń przewodu pokarmowego i interpretacja wyników badań (gastroskopia, USG, testy laboratoryjne).

Opieka internistyczna i profilaktyka:

Infekcje dróg oddechowych – kaszel, przeziębienie, zapalenie oskrzeli.
Analiza wyników badań laboratoryjnych, dostosowanie leczenia i leków.
Szczepienia dorosłych – dobór schematu i ocena przeciwwskazań.
Profilaktyka nowotworowa – planowanie badań przesiewowych i ocena ryzyka.
Holistyczne podejście do pacjenta – leczenie objawów, zapobieganie powikłaniom i poprawa jakości życia.

Lek. Biriukova łączy wiedzę internistyczną z podejściem specjalistycznym, oferując pacjentom jasne wyjaśnienia, przejrzyste plany leczenia i spersonalizowaną opiekę.

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Jak stosować LYUMJEV

Treść ulotki

Lyumjev 100 units/mL injectable solution in a vial
Lyumjev 100 units/mL injectable solution in cartridge
Lyumjev 100 units/mL KwikPen prefilled pen injectable solution
Lyumjev 100 units/mL KwikPen injectable solution in prefilled pen
Lyumjev 100 units/mL Junior KwikPen injectable solution in prefilled pen
Lyumjev 100 units/mL Junior KwikPen injectable solution in prefilled pen
Lyumjev 100 units/mL Tempo Pen prefilled pen solution for injection
Lyumjev 100 units/mL Tempo Pen injectable solution in a prefilled pen
Lyumjev 200 units/mL KwikPen pre-filled pen injectable solution
Lyumjev 200 units/mL KwikPen injectable solution in prefilled pen

Lyumjev 100 units/mL injectable solution 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, pharmacist or nurse.
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, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Lyumjev is and what it is used for
2. What you need to know before you use Lyumjev
3. How to use Lyumjev
4. Possible side effects
5. How to store Lyumjev
6. Contents of the pack and other information

1. What is Lyumjev and what is it used for

Lyumjev 100 units/mL injectable solution in a vial contains the active substance insulin lispro.
Lyumjev is used for the therapy of diabetes mellitus in adults, adolescents and children aged
1 year or older. It is a prandial insulin that acts more rapidly than other medicines
containing insulin lispro. Lyumjev contains components that accelerate the absorption of insulin
lispro into the body.
Diabetes is a condition in which the body does not produce enough insulin or does not use
insulin effectively, which results in effects such as high blood sugar levels. Lyumjev is
an insulin-based medicine used in the treatment of diabetes and therefore controls blood
sugar. Effective diabetes treatment, with good blood sugar control, prevents
long-term complications of diabetes.
Treatment with Lyumjev helps to control long-term blood sugar levels and prevent complications
of diabetes. Lyumjev exerts its maximum effect 1 to 3 hours after injection and this effect lasts
up to 5 hours. You should use Lyumjev at the beginning of the meal or up to 20 minutes after the start of the meal.
The doctor may prescribe both the use of Lyumjev and a long- or intermediate-acting insulin.
Do not change the type of insulin unless prescribed by your doctor.

2. What you need to know before using Lyumjev

DO NOT use Lyumjev

if you think your blood sugar is falling (hypoglycemia). Further on, this leaflet explains how to treat low blood sugar (see section 3 below “If you use more Lyumjev than you should”).
if you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Lyumjev.
If you cannot see very well, you will need the help of someone who has been trained to give
injections.

Low blood sugar(hypoglycemia) Low blood sugar can be serious and untreated hypoglycemia can even lead to death. Lyumjev starts to lower blood sugar faster than other prandial insulins. Hypoglycemia may occur earlier after an injection of Lyumjev. If you often experience hypoglycemia or have difficulty recognizing it, talk to your doctor or nurse. If your blood sugar is well controlled with the insulin therapy you are taking or if you have had diabetes for a long time, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. For symptoms, see "Common diabetes problems".

You must pay close attention to the timing of meals, the frequency and intensity of exercise.
You should also monitor your blood sugar levels frequently by measuring them.
Making changes to the types of insulin you use can cause excessive increases or decreases
in blood sugar levels.
You may need to increase the frequency of blood sugar tests if you are at risk of low
blood sugar levels. Your doctor may need to adjust the doses of your other diabetes medications.

High blood sugar(hyperglycemia) Stopping or taking insufficient insulin can cause high blood sugar (hyperglycemia) and diabetic ketoacidosis, serious conditions that can even lead to death. For symptoms, see "Common diabetes problems".
If you are using an insulin pump that stops working, you need to resolve the problem immediately, as it can cause high blood sugar. You may need to give yourself an injection of Lyumjev using an insulin pen or syringe if the pump stops working.
If your insulin treatment is combined with one of a class of diabetes medications called thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling caused by fluid retention (edema).
If you experience a severe allergic reaction to insulin or any of the ingredients of Lyumjev, stop using this medicine and contact emergency medical services immediately.
Always check the packaging and label for the name and type of insulin you receive from the pharmacist. Make sure your Lyumjev packaging matches what your doctor prescribed.
Keep the packaging or note the batch number on the packaging. If you experience an adverse reaction, you can provide this number when reporting the adverse reaction, see "Reporting of adverse reactions".
Always use a new needle for each injection to prevent infection and needle blockage. If a needle is blocked, replace it with a new needle.
Changes in skin at the injection siteThe 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 “How to use Lyumjev”). If you are currently injecting into an area with nodules, consult your doctor before starting to inject into another area. Your doctor may ask you to check your blood sugar more carefully and adjust your insulin or other diabetes medications.

Children and adolescents
This medicine is not recommended for use in children under 1 year of age.

Other medicines and Lyumjev
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or may
take any other medicines. Some medicines affect blood sugar levels; this
may mean that the dose of insulin needs to be adjusted.
Blood sugar levels can decrease (hypoglycemia) if you take:

other medicines for diabetes (oral and injectable)
sulfonamide antibiotics (for infections)
acetylsalicylic acid (for mild pain and fever and to prevent blood clotting)
some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors)
some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) (for some heart problems or high blood pressure)
angiotensin II receptor blockers (for high blood pressure or heart problems)
somatostatin analogs (such as octreotide, used to treat a rare disease characterized by excessive growth hormone production).

Blood sugar levels can increase (hyperglycemia) if you take:

danazol (for endometriosis)
the contraceptive pill (birth control pills)
thyroid hormone replacement therapy (for thyroid problems)
human growth hormone (for growth hormone deficiency)
diuretics (for high blood pressure or fluid retention)
sympathomimetic agents (for severe allergic reactions or used in some cold remedies)
corticosteroids (to treat asthma or autoimmune diseases).

Beta-blockers (used for hypertension, arrhythmia or angina) make it more difficult to recognize the signs
of low blood sugar.

Lyumjev with alcohol
Blood sugar levels can increase or decrease if you drink alcohol. Therefore, the amount
of insulin needed may change. You should therefore check your blood sugar more
often than usual.

Pregnancy and breastfeeding
If you are planning a pregnancy, if you suspect you are pregnant, are pregnant or if you are
breastfeeding, ask your doctor, pharmacist or nurse for advice before
taking this medicine. The amount of insulin you need generally decreases during
the first 3 months of pregnancy and increases during the remaining 6 months. After having the baby, your insulin needs will probably return to your needs before pregnancy.
There are no restrictions on the use of Lyumjev during breastfeeding. If you are breastfeeding, you
may need to adjust the amount of insulin you are taking or your diet.

Driving and using machines
Your ability to concentrate and react may be reduced in case of 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 to
find out if you can drive if you have:

frequent episodes of hypoglycemia
reduced or absent warning signs of hypoglycemia.

Lyumjev contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially “sodium
free”.

3. How to use Lyumjev

or following the instructions of your doctor, pharmacist or nurse. If you have doubts, consult your doctor, pharmacist or nurse.
Your doctor, pharmacist or nurse will tell you exactly how much Lyumjev to use, when to use it and
how often. They will also tell you how often to visit the diabetes center.
You should always have a supply of reserve insulin and another injection device with you in case you
need it.
If you are blind or have low vision, you will need someone's help to administer the injections.
Your doctor may tell you to use both Lyumjev and a longer- or intermediate-acting insulin. These must
be injected separately. Lyumjev must not be mixed with any other insulin.

When to inject Lyumjev
Lyumjev is a prandial insulin. You must use Lyumjev when you start to eat, or one or two
minutes before your meal; you can also choose to inject the medicine up to 20 minutes after starting your meal.

How much insulin to use
Your doctor will determine the dose based on your blood sugar and body weight and will explain to you:

how much Lyumjev you need with each meal;
how and when to check your blood sugar level;
how to adjust the insulin dose based on blood sugar levels;
what to do if you change your diet or change the amount of physical activity, if you are sick or if you are using other medicines;
if you change the type of insulin you are using, you may need to take more or less of it than before. This may be necessary only for the first injection or may be a gradual change over several weeks or months.

Do not use Lyumjev

If it does not look like water. Lyumjev must be clear, colorless and free of solid particles. Check every time before injection.
If Lyumjev has not been stored correctly (see section 5 "How to store Lyumjev").
If the plastic cap of the vial is damaged, do not use.

Where to inject

Inject Lyumjev under the skin (subcutaneous injection).
Do not inject the medicine directly into a vein. Only your doctor can administer Lyumjev intravenously and will only do so in special circumstances, such as surgery or if you are sick and blood sugar levels are too high.
Make sure to inject at least 1 cm away from the last injection and to "rotate" the injection sites (arm, thigh, buttocks or abdomen), as you have been taught.
If you need to inject another insulin at the same time as Lyumjev, use a different injection site.

How to inject Lyumjev from a vial

First, wash your hands.
Before giving 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 new syringe and needle to puncture the rubber stopper and draw the amount of Lyumjev needed for injection. Your doctor, nurse or diabetes center will show you exactly how to do this. Do not share needles and syringes with other people.
Inject the medicine under the skin as you have been taught. After the injection, leave the needle in the skin for 5 seconds to make sure you have injected the entire dose.

Using Lyumjev in an insulin microinfusor

Only some insulin microinfusors can be used for the infusion of Lyumjev.
Follow the instructions provided with the microinfusor carefully.
Make sure to use the appropriate reservoir and catheter for the microinfusor. To avoid damaging the microinfusor, it is important to use a needle of the correct length in the filling system.
Change the infusion set (tube and needle) following the instructions included with the infusion set.
If you experience repeated or severe episodes of reduced blood sugar levels, inform your doctor or nurse.
A malfunction of the microinfusor 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 Lyumjev, follow the instructions in the documentation that accompanies the microinfusor and, if appropriate, report it to your doctor or nurse.
You may need to give an injection of Lyumjev if the microinfusor is not working properly.

After the injection
If you are not sure how much medicine you have injected, check your blood sugar before
deciding if you need another injection.

If you use more Lyumjev than you should
If you have injected too much Lyumjev, or are not sure how much you have injected, a
decrease in blood sugar level may occur. Check your blood sugar.
If your blood sugar is low (hypoglycemia )and you are able to treat it yourself, eat glucose tablets, sugar or take a sugary drink. Then eat fruit, cookies or a
sandwich, as suggested by your doctor or nurse and rest. This is often enough to
counteract a low blood sugar level, or a modest overdose of insulin.
Check your blood sugar again after 15-20 minutes until your blood sugar is stabilized.
If you are unable to take care of yourself (severe hypoglycemia) because you are dizzy, weak,
confused, have difficulty speaking, lose consciousness or have convulsions, you may need to be
treated with glucagon. Glucagon can be administered by someone who knows how to use it.
Eat glucose or sugar after glucagon. If glucagon does not work, you will need to go to the hospital or
call emergency services. Ask your doctor about glucagon.
Tell everyone you spend time with that you have diabetes. Tell them what might
happen if your blood sugar gets too low, including the risk of fainting.
Tell them that if you were to faint, they should: turn you onto your side to prevent choking, ask
for immediate medical assistance and do not try to give you food or drink because you could choke.

If you forget to use Lyumjev
If you forget to use insulin or use less than you should, or are not sure how much you injected, your
blood sugar may rise too high (hyperglycemia). Check your blood sugar to
decide if you need a dose of insulin. Resume your usual dosing schedule at the next
meal.

If you stop using Lyumjev
Do not stop or change the type of insulin unless prescribed by your doctor.
If you use less Lyumjev than you should, your blood sugar level may increase.
If high blood sugar (hyperglycemia) is not treated, it can be very serious and
cause headache, nausea, vomiting, abdominal pain, dehydration, loss of consciousness, coma or
even death (see section 4).

Three simple precautionsto reduce the risk of hypoglycemia or hyperglycemia:

always keep a supply of syringes and a vial of Lyumjev on hand;
always carry a document indicating that you have diabetes;
always carry sugar with you.

If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A low blood sugar level (hypoglycemia)is very common during insulin treatment
(may affect more than 1 in 10 people). It can be very serious. If your blood sugar level
drops too low, you may lose consciousness. Severe hypoglycemia can cause brain damage and can
be life-threatening. If you have symptoms related to a low blood sugar level, act

immediatelyto raise your blood sugar level. See paragraph 3 under "If you use
more Lyumjev than you should".
Allergic reactionsare common (may affect up to 1 in 10 people). They can be serious
and may include the following symptoms:
skin rash and feeling of
itching all over the body
difficulty breathing
wheezing
low blood pressure
fast heartbeat
sweating

In case of a severe allergic reaction(including anaphylactic shock) to insulin or any
of the excipients of Lyumjev, stop using this medicine and contact the emergency medical
service immediately.

Other side effects include
Very common(may affect more than 1 in 10 people)
Reactions at the infusion site. Some people experience redness, pain, swelling, or itching
in the area of insulin infusion. If you have infusion site reactions, tell your doctor.

Common(may affect up to 1 in 10 people)
Reactions at the injection site. Some people experience redness, pain, swelling, or itching
in the area of insulin injection. This usually resolves within a few minutes or weeks
without the need to stop Lyumjev. Tell your doctor about injection site reactions.

Uncommon(may affect up to 1 in 100)
Changes in the skin at the injection site: 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.

Other potential side effects
Swelling of the arms or ankles due to fluid retention (edema), especially at the beginning
of insulin therapy or during a change in diabetes medicines.

Reporting of side effects
If you get any side effect, talk to 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 problems with diabetes
Low blood sugar
A low blood sugar level (hypoglycemia) means that there is not enough sugar in
the blood. It can happen if:

you take too much Lyumjev or another insulin;
you delay or miss a meal or if you change your diet;
you do too much exercise or strenuous physical effort immediately before or after a meal;
you have an infection or other illness (especially diarrhea or vomiting);
there is a change in your insulin needs, for example if you lose weight, or if a pre-existing kidney or liver disorder gets worse. See the paragraph "If you use more Lyumjev than you should".

Usually, the first symptoms of hypoglycemia come on quickly and include:

tiredness
fast heartbeat
nervousness or agitation
feeling unwell
headache
cold sweat.

If you are unable to recognise the warning signs of hypoglycemia, avoid situations, such as
driving, where hypoglycemia could put you or others at risk.

High blood sugar(hyperglycemia) and diabetic ketoacidosis
Hyperglycemia (too much sugar in the blood) means that the glucose levels in your body are
too high. Hyperglycemia can be caused by:

not taking enough insulin;
using less insulin than you need;
an imbalance between the amount of carbohydrates you eat and the insulin you take; or
fever, infection, or a strong emotion.

The early symptoms of hyperglycemia are:

being very thirsty
headache
feeling sleepy
needing to urinate more often.

Hyperglycemia can lead to diabetic ketoacidosis. The early symptoms develop slowly, over
many hours or days. Further symptoms include:

nausea and/or vomiting
stomach pain
rapid breathing
heavy breathing
moderate or large amounts of ketones in the urine. Ketones are produced when the body burns fat for energy instead of glucose.

If you have any of these symptoms and high blood sugar seek immediate medical attention.
See the paragraph “If you forget to take Lyumjev”.

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, follow the precautions you already know when you are ill, and tell your doctor.

5. How to store Lyumjev

Keep this medicine 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 freeze
Keep in the original package to protect from light.

Before first use
Store in a refrigerator (2 °C – 8 °C).

After first use
Do not store at a temperature above 30 °C.
Discard after 28 days even if some of the solution remains.
Do not dispose of any medicine in 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 Lyumjev 100 units/mL injectable solution in a vial contains

The active ingredient is insulin lispro. Each mL of solution contains 100 units of insulin lispro. One vial contains 1,000 units of insulin lispro in 10 mL of solution.
The excipients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, sodium treprostinil, zinc oxide, water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH (see at the end of paragraph 2 under “Lyumjev contains sodium”).

Description of the appearance of Lyumjev and contents of the pack
Lyumjev 100 units/mL, injectable solution is a clear, colorless aqueous solution contained in a
vial.
Each vial contains 1,000 units (10 milliliters).
Pack of 1, 2 or multi-pack containing 5 x 1 vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France
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 "Eli Lilly Nederland" B.V. - 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
Dista 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
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

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu .
--------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
Lyumjev 100 units/mL is available in vials if intravenous injection is required.
For intravenous use, Lyumjev must be diluted to concentrations of 0.1 to 1.0 units/mL in a
5 % glucose solution or a 0.9 % sodium chloride solution (0.9 % saline).
It is recommended to prime the system before starting the infusion to the patient.
Compatibility has been demonstrated with ethylene-propylene copolymer and polyvinyl chloride and
polyolefin bags.
Chemical and physical stability has been demonstrated during use for 14 days at 2 – 8 °C and 20 hours at 20 – 25 °C
when protected from light. From a microbiological point of view, the medicinal product must be used
immediately. If not used immediately, the storage times and conditions before use are the responsibility of the
user and should not normally exceed 24 hours at

2 – 8 °C, unless the dilution has taken place in controlled and validated aseptic conditions.

Lyumjev 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, pharmacist or nurse.
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, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Lyumjev is and what it is used for
2. What you need to know before you use Lyumjev
3. How to use Lyumjev
4. Possible side effects
5. How to store Lyumjev
6. Contents of the pack and other information

1. What is Lyumjev and what it is used for

Lyumjev 100 units/mL injectable solution in cartridge contains the active substance insulin lispro.
Lyumjev is used for the therapy of diabetes mellitus in adults, adolescents and children aged
1 year or older. It is a prandial insulin that acts more rapidly than other medicines
containing insulin lispro. Lyumjev contains components that accelerate the absorption of insulin
lispro into the body.
Diabetes is a condition in which the body does not produce enough insulin or does not use
insulin effectively, which results in effects such as high blood sugar levels. Lyumjev
is a medicine based on insulin used in the treatment of diabetes and therefore controls blood
sugar. Effective treatment of diabetes, with good blood sugar control,
prevents the long-term complications of diabetes.
Treatment with Lyumjev helps to control blood glucose in the long term and to prevent the complications
of diabetes. Lyumjev exerts its maximum effect 1 to 3 hours after injection and this effect lasts
up to 5 hours. You must use Lyumjev at the beginning of the meal or up to 20 minutes after the start of the meal.
The doctor may prescribe both the use of Lyumjev and a long- or intermediate-acting insulin.
Do not change the type of insulin unless prescribed by your doctor.

2. What you need to know before using Lyumjev

DO NOT use Lyumjev

if you think your blood sugar level is falling (hypoglycemia). Further on, this leaflet explains how to treat low blood sugar (see section 3 below “If you use more Lyumjev than you should”).
if you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Lyumjev.
If you cannot see very well, you will need the help of someone who has been trained to give
injections.

Low blood sugar(hypoglycemia) Low blood sugar can be serious and untreated hypoglycemia can even lead to death. Lyumjev starts to lower blood sugar faster than other prandial insulins. Hypoglycemia may occur earlier after an injection of Lyumjev. If you often have hypoglycemia or have difficulty recognizing it, talk to your doctor or nurse. If your blood sugar is well controlled by the insulin therapy you are taking or if you have had diabetes for a long time, you may not notice the warning signs when your blood sugar is dropping too much. The warning signs are listed later in this leaflet. For symptoms, see "Common diabetes problems".

You must pay close attention to the timing of meals, the frequency and intensity of exercise.
You should also monitor your blood sugar levels frequently by measuring them.
Making changes to the types of insulin you use can cause an excessive increase or decrease
in blood sugar levels.
You may need to increase the frequency of blood sugar checks if you are at risk of low
blood sugar levels. Your doctor may need to adjust the doses of your other diabetes medications.

High blood sugar(hyperglycemia) Stopping or taking insufficient insulin can cause high blood sugar (hyperglycemia) and diabetic ketoacidosis, serious conditions that can even lead to death. For symptoms, see "Common diabetes problems".
If insulin treatment is combined with one of a class of diabetes medications called thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling caused by fluid retention (edema).
If you experience a severe allergic reaction to insulin or any of the components of Lyumjev, stop using this medicine and contact emergency medical services immediately.
Always check the package and label for the name and type of insulin you are given by the pharmacist. Make sure your Lyumjev package matches what your doctor has prescribed.
Keep the package or note the batch number on the package. If you experience an adverse effect, you can provide this number when reporting the adverse effect, see "Reporting adverse effects".
Always use a new needle for each injection to prevent infection and needle blockage. If a needle is blocked, replace it with a new needle.
Skin changes at the injection siteThe 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 “How to use Lyumjev”). If you are currently injecting into an area with nodules, consult your doctor before starting to inject into another area. Your doctor may ask you to check your blood sugar more carefully and adjust your insulin dose or other antidiabetic medications.

Children and adolescents
This medicine is not recommended for use in children under 1 year of age.

other diabetes medicines (oral and injectable)
sulfonamide antibiotics (for infections)
acetylsalicylic acid (for mild pain and fever and to prevent blood clotting)
some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors)
some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) (for some heart problems or high blood pressure)
angiotensin II receptor blockers (for high blood pressure or heart problems)
somatostatin analogs (such as octreotide, used to treat a rare disease characterized by excessive growth hormone production).

Blood sugar levels may increase (hyperglycemia) if you take:

danazol (for endometriosis)
the contraceptive pill (birth control pills)
replacement thyroid hormone therapy (for thyroid problems)
human growth hormone (for growth hormone deficiency)
diuretics (for high blood pressure or fluid buildup in the body)
sympathomimetic agents (for severe allergic reactions or used in some cold remedies)
corticosteroids (to treat asthma or autoimmune diseases).

Beta-blockers (used for hypertension, arrhythmia or angina) make it more difficult to recognize the signs
of low blood sugar.

Lyumjev with alcohol
Blood sugar levels may increase or decrease if you drink alcohol. Therefore, the amount
of insulin needed may change. You should therefore check your blood sugar more
often than usual.

Pregnancy and breastfeeding
If you are planning a pregnancy, suspect you are pregnant, are pregnant or are
breastfeeding, ask your doctor, pharmacist or nurse for advice before
taking this medicine. The amount of insulin you need generally decreases during
the first 3 months of pregnancy and increases during the remaining 6 months. After having the baby, your insulin needs will probably return to your needs before pregnancy.
There are no restrictions on the use of Lyumjev during breastfeeding. If you are breastfeeding, you
may need to adjust the amount of insulin you are taking or your diet.

frequent episodes of hypoglycemia
reduced or absent warning signs of hypoglycemia.

Lyumjev contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Lyumjev

or following the instructions of your doctor, pharmacist or nurse. If you have any doubts, consult your doctor, pharmacist or nurse.
Your doctor, pharmacist or nurse will tell you exactly how much Lyumjev to use, when to use it and
how often. They will also tell you how often to visit the diabetes center.
To prevent possible transmission of disease, each cartridge must be used only by you, even
if the needle on the pen is replaced.
You should always have spare insulin and another injection device with you in case you need it.
If you are blind or have low vision, you will need someone's help to administer the injections.
Your doctor may tell you to use both Lyumjev and a longer- or intermediate-acting insulin. These must
be injected separately. Lyumjev must not be mixed with any other insulin.

When to inject Lyumjev
Lyumjev is a prandial insulin. You should use Lyumjev when you start to eat, or one or two
minutes before your meal; you can also choose to inject the medicine up to 20 minutes after starting your meal.

How much insulin to use
Your doctor will determine the dose based on your blood sugar and body weight and will explain to you:

how much Lyumjev you need with each meal;
how and when to check your blood sugar level;
how to adjust the insulin dose based on blood sugar levels;
what to do if you change your diet or change the amount of physical activity, if you are sick or if you are using other medicines;
if you change the type of insulin you are using, you may need to take more or less of it than before. This may be necessary only for the first injection or may be a gradual change over several weeks or months.

Do not use Lyumjev

If it does not look like water. Lyumjev must be clear, colorless and free of solid particles. Check every time before injection.
If Lyumjev has not been stored correctly (see section 5 "How to store Lyumjev").
If any part of the cartridge appears damaged, do not use.

Preparing the pen

First, wash your hands. Disinfect the rubber membrane of the cartridge.
You must use Lyumjev cartridges only with Lilly insulin pens. Make sure the words

3 mL cartridge can only be used with the 3 mL pen.

Follow the instructions included with the pen. Insert the cartridge into the pen.
Use a new needle (needles are not included in the package).
Prime the pen every time. The pen must be primed until you see insulin at the tip of the needle before each injection, to ensure that the pen is ready for the dose. If you do not prime the pen, you may inject an incorrect dose.

Injecting Lyumjev

Before injecting, disinfect the skin.
Inject the medicine under the skin (subcutaneous injection), as you have been taught by your doctor or nurse.
After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Make sure to inject at least 1 cm away from the last injection and to "rotate" the injection sites (arm, thigh, buttocks or abdomen).
If there is not enough insulin in the pen to complete the dose, note how much more you need to take. Load a new pen and inject the remaining dose.
If you need to inject another insulin at the same time as Lyumjev, use a different injection site.
Do not inject the medicine directly into a vein.

After the injection

As soon as you have finished the injection, remove the needle from the pen using the outer needle cap. This will help keep Lyumjev sterile and prevent leakage of the medicine. It will also stop air from entering the pen and blocking the needle. Do notshare your needles with other people. Do not share your pen with other people.Reposition the cap on the pen. Leave the cartridge in the pen.
If you are unsure how much medicine you have injected, check your blood sugar levels before deciding if you need another injection.

Subsequent injections

Each time you plan to administer an injection, use a new needle. Before each injection, prime the pen to remove larger air bubbles.
Once the cartridge is empty, do not reuse it.

If you use more Lyumjev than you should
If you have injected too much Lyumjev, or are unsure how much you have injected, you may
experience a decrease in blood sugar level. Check your blood sugar level.
If your blood sugar level is low (hypoglycemia )and you are able to treat it yourself, eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits or a
sandwich, as suggested by your doctor or nurse, and rest. This is often enough to
counteract mild hypoglycemia or a moderate overdose of insulin. Check your blood sugar again after 15-20 minutes until your blood sugar has stabilized.
If you are unable to take care of yourself (severe hypoglycemia) because you are dizzy, weak,
confused, have difficulty speaking, lose consciousness or have convulsions, you may need to be
treated with glucagon. Glucagon can be administered by someone who knows how to use it.
Eat glucose or sugar after glucagon. If glucagon does not work, you will need to go to the hospital or
call emergency services. Ask your doctor for information about glucagon.
Inform everyone you spend time with that you have diabetes. Tell them what might
happen if your blood sugar drops too low, including the risk of fainting.
Tell them that if you were to faint, they should: turn you onto your side to prevent choking, seek
immediate medical assistance and do not try to give you food or drink because you could choke.

If you forget to take Lyumjev
If you forget to use the insulin or use less than you should, or are unsure how much you have injected, your
blood sugar may rise too high (hyperglycemia). Check your blood sugar level to
decide if you need an insulin dose. Resume your usual dosage schedule at the next meal.

If you stop treatment with Lyumjev
Do not stop or change the type of insulin unless prescribed by your doctor.
If you use less Lyumjev than you should, your blood sugar level may increase.
If high blood sugar (hyperglycemia) is not treated, it can be very serious and
cause headache, nausea, vomiting, abdominal pain, dehydration, loss of consciousness, coma or
even death (see section 4).

Three simple precautionsto reduce the risk of hypoglycemia or hyperglycemia:

always have a spare pen and cartridges, in case you lose your pen or cartridges or they are damaged;
carry a document with you indicating that you have diabetes;
carry sugar with you.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A low blood sugar level (hypoglycemia)is very common in treatment with insulin
(may affect more than 1 in 10 people). It can be very serious. If your blood sugar level
drops too low, you may lose consciousness. Severe hypoglycemia can cause damage to the brain and can
be life-threatening. If you have symptoms related to a low blood sugar level, act

immediatelyto raise your blood sugar level. See paragraph 3 "If you use more
Lyumjev than you should".
Allergic reactionsare common (may affect up to 1 in 10 people). They can be serious
and may include the following symptoms:
skin rash and sensation of
itching all over the body
difficulty breathing
wheezing
low blood pressure
fast heartbeat
sweating

In case of a severe allergic reaction(including anaphylactic shock) to insulin or any
of the excipients of Lyumjev, stop using this medicine and contact the emergency medical service immediately.

Other side effects include
Common(may affect up to 1 in 10 people)
Reactions at the injection site. Some people experience redness, pain, swelling, or itching
in the area of insulin injection. This usually resolves within a few minutes or weeks
without the need to stop Lyumjev. Tell your doctor if you have injection site reactions.

Uncommon(may affect up to 1 in 100)
Changes in the skin at the injection site: 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 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 lumps.
Change the injection site with each injection to prevent these skin changes.

Other potential side effects
Swelling of the arms or ankles due to fluid retention (edema), especially at the beginning
of insulin therapy or during a change in diabetes medications.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through your
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
Low blood sugar
A low blood sugar level (hypoglycemia) indicates that there is not enough sugar in
the blood. It can occur if:

you take too much Lyumjev or another insulin;
you delay or miss a meal, or if you change your diet;
you do excessive physical activity or exertion immediately before or after a meal;
you have an infection or other illness (especially diarrhea or vomiting);
there is a change in your insulin needs, for example if you lose weight, or if a pre-existing kidney or liver disorder worsens. See the paragraph "If you use more Lyumjev than you should".

Usually, the first symptoms of hypoglycemia come on quickly and include:

tiredness
fast heartbeat
nervousness or agitation
feeling unwell
headache
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.

High blood sugar(hyperglycemia) and diabetic ketoacidosis
Hyperglycemia (too much sugar in the blood) indicates that the glucose levels in your body are
too high. Hyperglycemia can be caused by:

not taking enough insulin;
using less insulin than you need for your body;
an imbalance between the amount of carbohydrates you eat and the insulin you take; or
fever, infection, or strong emotion.

The first symptoms of hyperglycemia are:

feeling very thirsty
headache
feeling sleepy
increased need to urinate.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. Further symptoms include:

nausea and/or vomiting
abdominal pain
rapid pulse
heavy breathing
moderate or large amounts of ketones in the urine. Ketones are produced when the body burns fat for energy instead of glucose.

If you have any of these symptoms and high blood sugar seek immediate medical attention.
See the paragraph “If you forget to take Lyumjev”.

Illnesses
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, follow the precautions you already know when you are sick, and tell your doctor.

5. How to store Lyumjev

Before first use
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep in the original package to protect from light.

After first use (after inserting the cartridge into the pen)
Do not store at a temperature above 30 °C.
Do not freeze.
Do not refrigerate.
The pen with the inserted cartridge must not be stored with the needle attached.
Keep the cap on the pen to protect from light.
Dispose of after 28 days even if some of the solution remains.
Do not dispose of any medicine in 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 Lyumjev 100 units/mL injectable solution in cartridge contains

The active substance is insulin lispro. Each mL of solution contains 100 units of insulin lispro. One cartridge contains 300 units of insulin lispro in 3 mL of solution.
The excipients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, sodium treprostinil, zinc oxide, water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH (see at the end of paragraph 2 under “Lyumjev contains sodium”).

Description of the appearance of Lyumjev and contents of the pack
Lyumjev 100 units/mL, injectable solution is a clear, colorless aqueous solution contained in
a cartridge.
Each cartridge contains 300 units (3 milliliters).
Packs of 2, 5, 10 cartridges.
Not all pack sizes may be marketed.

Marketing authorisation holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France
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 "Eli Lilly Nederland" B.V. - България
T ел.: + 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
Dista 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
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

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu .

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Lyumjev 100 units/mL KwikPen prefilled pen injectable solution

insulin lispro

Each KwikPen delivers from 1 to 60 units in 1-unit increments per single injection.
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, pharmacist or nurse.
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, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Lyumjev KwikPen is and what it is used for
2. What you need to know before you use Lyumjev KwikPen
3. How to use Lyumjev KwikPen
4. Possible side effects
5. How to store Lyumjev KwikPen
6. Contents of the pack and other information

1. What is Lyumjev KwikPen and what is it used for

Lyumjev 100 units/mL KwikPen pre-filled pen injectable solution contains the active ingredient
insulin lispro. Lyumjev is used for the treatment of diabetes mellitus in adults, adolescents and
children aged 1 year and over. It is a prandial insulin that acts more rapidly than other
medicines containing insulin lispro. Lyumjev contains components that accelerate the absorption
of insulin lispro into the body.
Diabetes is a condition in which the body does not produce enough insulin or does not use
insulin effectively, which results in effects such as high blood sugar levels. Lyumjev is
an insulin-based medicine used in the treatment of diabetes and therefore controls blood
sugar. Effective diabetes treatment, with good blood sugar control, prevents
long-term complications of diabetes.
Treatment with Lyumjev helps to control long-term blood sugar and prevent
complications of diabetes. Lyumjev exerts its maximum effect 1 to 3 hours after injection and this effect lasts
up to 5 hours. You must use Lyumjev at the beginning of the meal or up to 20 minutes after the start of the meal.
The doctor may prescribe both the use of Lyumjev and a long- or intermediate-acting insulin.
Do not change the type of insulin unless prescribed by your doctor.
Lyumjev 100 units/mL 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 1 unit at a time. The number of units is visible in the
dosage window, always check it before injection.You can administer 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 Lyumjev KwikPen

DO NOT use Lyumjev KwikPen

if you think your blood sugar level is falling (hypoglycemia). Further on, this leaflet explains how to treat low blood sugar (see section 3 under “If you use more Lyumjev than you should”).
if you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Lyumjev.
If you cannot see very well, you will need the help of someone who has been trained to give
injections.

Low blood sugar(hypoglycemia) Low blood sugar can be serious and untreated hypoglycemia can also lead to death. Lyumjev starts to lower blood sugar faster than other prandial insulins. Hypoglycemia may occur earlier after an injection of Lyumjev. If you often have hypoglycemia or have difficulty recognizing it, talk to your doctor or nurse. If your blood sugar is well controlled by the insulin therapy you are taking or if you have had diabetes for a long time, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. For symptoms, see "Common diabetes problems".

You must pay close attention to the timing of meals, the frequency and intensity of physical exercise.
You should also monitor your blood sugar levels frequently by measuring them.
Making changes to the types of insulin you use can cause excessive increases or decreases
in blood sugar levels.
You may need to increase the frequency of blood sugar checks if you are at risk of low
blood sugar levels. Your doctor may need to adjust the doses of your other diabetes medications

High blood sugar(hyperglycemia) Stopping or taking insufficient insulin can cause high blood sugar (hyperglycemia) and diabetic ketoacidosis, serious conditions that can also lead to death. For symptoms, see "Common diabetes problems".
If insulin treatment is combined with one of a class of diabetes medicines called thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling caused by fluid retention (edema).
If you experience a severe allergic reaction to insulin or any of the components of Lyumjev, stop using this medicine and contact emergency medical services immediately.
Always check the package and label for the name and type of insulin you are given by the pharmacist. Make sure your Lyumjev package matches the one your doctor prescribed.
Keep the package or note the batch number on the package. If you experience an adverse effect, you can provide this number when reporting the adverse effect, see "Reporting adverse effects".
Always use a new needle for each injection to prevent infections and needle blockage. If a needle is blocked, replace it with a new needle.
Changes in the skin at the injection siteThe 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 into an area with nodules (see “How to use Lyumjev KwikPen”). If you are currently injecting into

an area with nodules, consult your doctor before starting to inject into another area. The
doctor may ask you to check your blood sugar more carefully and adjust the dose of insulin or
other antidiabetic medications.

Children and adolescents
This medicine is not recommended for use in children under 1 year of age.

other medicines for diabetes (oral and injectable)
sulfonamide antibiotics (for infections)
acetylsalicylic acid (for mild pain and fever and to prevent blood clotting)
some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors)
some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) (for some heart problems or high blood pressure)
angiotensin II receptor blockers (for high blood pressure or heart problems)
somatostatin analogs (such as octreotide, used to treat a rare disease characterized by excessive growth hormone production).

Blood sugar levels may increase (hyperglycemia) if you take:

danazol (for endometriosis)
the contraceptive pill (birth control pills)
replacement thyroid hormone therapy (for thyroid problems)
human growth hormone (for growth hormone deficiency)
diuretics (for high blood pressure or fluid buildup in the body)
sympathomimetic agents (for severe allergic reactions or used in some cold remedies)
corticosteroids (to treat asthma or autoimmune diseases)

Beta-blockers (used for hypertension, arrhythmia or angina) make it harder to recognize the signs
of low blood sugar.

Pregnancy and breastfeeding
If you are planning a pregnancy, suspect you are pregnant, are pregnant or are
breastfeeding, ask your doctor, pharmacist or nurse for advice before
taking this medicine. The amount of insulin you need generally decreases during
the first 3 months of pregnancy and increases during the remaining 6 months. After having the baby, your insulin needs will likely return to your needs before pregnancy.
There are no restrictions on the use of Lyumjev during breastfeeding. If you are breastfeeding, you
may need to adjust the amount of insulin you are taking or your diet.

frequent episodes of hypoglycemia
reduced or absent warning signs of hypoglycemia.

Lyumjev 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 Lyumjev KwikPen

or by following the instructions of your doctor, pharmacist or nurse. If you have any doubts, consult your doctor, pharmacist or nurse.
Your doctor, pharmacist or nurse will tell you exactly how much Lyumjev to use, when to use it and
how often. They will also tell you how often to visit the diabetes center.
To prevent possible transmission of diseases, each pen must be used only by you, even if
the needle is changed.
You should always have spare insulin and another injection device with you in case you need it.
If you are blind or visually impaired, you will need someone's help to administer the injections.
Your doctor may tell you to use both Lyumjev and a longer- or intermediate-acting insulin. These must
be injected separately. Lyumjev must not be mixed with any other insulin.

How much insulin to use
Your doctor will determine the dose based on your blood sugar and body weight and will explain to you:

how much Lyumjev you need with each meal;
how and when to check your blood sugar level;
how to adjust the insulin dose based on blood sugar levels;
what to do if you change your diet or change the amount of physical activity, if you are sick or if you are using other medicines;
if you change the type of insulin you are using, you may need to take more or less of it than before. This may be necessary only for the first injection or may be a gradual change over several weeks or months.

Do not use Lyumjev

If it does not look like water. Lyumjev must be clear, colorless and free of solid particles. Check this before each injection.
If Lyumjev has not been stored correctly (see section 5 "How to store Lyumjev").
If any part of the pen appears damaged, do not use.

Preparing the KwikPen to make it ready for use (see instructions for use)

First, wash your hands.
Read the instructions on how to use your prefilled insulin pen. Follow the instructions carefully. Below are some important points.
Use a new needle. (Needles are not included in the package).
Prime the KwikPen each time before use. This allows you to check that the insulin is flowing and to eliminate air bubbles from the KwikPen. Some small air bubbles may remain in the pen. Small air bubbles are normal and do not affect the dose to be injected.
The number of units is displayed in the dosage window, always check it before injection.

Injecting Lyumjev

Before giving the injection, disinfect the skin.
Inject the medicine under the skin (subcutaneous injection), as you have been taught by your doctor or nurse.
After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Make sure to inject at least 1 cm away from the last injection and to "rotate" the injection sites (arm, thigh, buttocks or abdomen).
If there is not enough insulin in the pen to complete the dose, note how much more you need to take. Load a new pen and inject the remaining dose.
If you need to inject another insulin at the same time as Lyumjev, use a different injection site.
Do not inject the medicine directly into a vein.

After the injection

As soon as you have finished the injection, remove the needle from the KwikPen using the outer needle cap. This will help keep the insulin sterile and prevent leakage of the medicine. It will also stop air from entering the pen and blocking the needle. Do notshare your needles with other people. Do not share your pen with other people.Replace the cap on the pen.
If you are unsure how much medicine you have injected, check your blood sugar levels before deciding if you need another injection.

Subsequent injections

Each time you use a KwikPen you must use a new needle. Before each injection, remove any air bubbles. You can check how much insulin is left in the pen by holding the KwikPen vertically, with the needle pointing upwards.
Once the KwikPen is empty, do not reuse it.

If you use more Lyumjev than you should
If you have injected too much Lyumjev, or if you are unsure 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 (hypoglycemia )and you are able to treat it yourself, eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits or a
sandwich, as suggested by your doctor or nurse and rest. This is often enough to counteract mild hypoglycemia or a modest overdose of insulin. Check your blood sugar again after 15-20 minutes until your blood sugar has stabilized.
If you are unable to take care of yourself (severe hypoglycemia) because you are dizzy, weak,
confused, have difficulty speaking, lose consciousness or have convulsions, you may need to be treated with glucagon. Glucagon can be administered by someone who knows how to use it.
Eat glucose or sugar after glucagon. If glucagon does not work, you will need to go to the hospital or
call emergency services. Ask your doctor about glucagon.
Tell everyone you spend time with that you have diabetes. Tell them what could
happen if your blood sugar drops too low, including the risk of fainting.
Tell them that if you were to faint, they should: turn you onto your side to prevent choking, seek
immediate medical assistance and do not try to give you food or drink as you could choke.

If you forget to use Lyumjev
If you forget to use the insulin or use less than you should, or if you are unsure how much you have injected, your
blood sugar may become too high (hyperglycemia). Check your blood sugar level to
decide if you need an insulin dose. Resume your usual dosing schedule at the next meal.

Three simple precautionsto reduce the risk of hypoglycemia or hyperglycemia:

always have a spare pen with you, in case you lose your KwikPen or it is damaged;
always carry a document indicating that you have diabetes;
always carry sugar with you.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

immediatelyto raise your blood sugar level. See paragraph 3 "If you use more
Lyumjev than you should".
Allergic reactionsare common (may affect up to 1 in 10 people). They can be serious
and may include the following symptoms:
skin rash and feeling of
itching all over the body
difficulty breathing
wheezing
low blood pressure
fast heartbeat
sweating

In case of a severe allergic reaction(including anaphylactic shock) to insulin or any
of the excipients of Lyumjev, stop using this medicine and contact the emergency medical
service immediately.

Other side effects include
Common(may affect up to 1 in 10 people)
Reactions at the injection site. Some people experience redness, pain, swelling or itching
in the area of insulin injection. This usually resolves within a few minutes or weeks without
the need to stop Lyumjev. Tell your doctor if you experience injection site reactions.

Uncommon(may affect up to 1 in 100)
Changes in the skin at the injection site: 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 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 lumps.
Change the injection site with each injection to prevent these skin changes.

Other potential side effects
Swelling of the arms or ankles due to fluid retention (edema), especially at the beginning
of insulin therapy or during a change in diabetes medications.

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 reported in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

Common diabetes problems
Low blood sugar level
A low blood sugar level (hypoglycemia) indicates that there is not enough sugar in
the blood. It can occur if:

you take too much Lyumjev or another insulin;
you delay or skip a meal, or if you change your diet;
you do excessive physical activity or exertion immediately before or after a meal;
you have an infection or other illness (especially diarrhea or vomiting);
there is a change in your insulin needs, for example in case of weight loss, or if there is a worsening of a pre-existing kidney or liver disorder. See the paragraph "If you use more Lyumjev than you should".

Usually, the first symptoms of hypoglycemia come on quickly and include:

fatigue
fast heartbeat
nervousness or agitation
feeling unwell
headache
cold sweat.

If you are unable to recognize the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, in which hypoglycemia could put you or others at risk.

High blood sugar level(hyperglycemia) and diabetic ketoacidosis
Hyperglycemia (too much sugar in the blood) indicates that the glucose levels in your body are
too high. Hyperglycemia can be caused by:

not taking enough insulin;
using less insulin than you need for your body;
an imbalance between the amount of carbohydrates you eat and the insulin you take; or
fever, infection or strong emotion.

The first symptoms of hyperglycemia are:

feeling very thirsty
headache
feeling sleepy
increased need to urinate.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms develop slowly, over
many hours or days. Further symptoms include:

nausea and/or vomiting
abdominal pain
rapid pulse
heavy breathing
moderate or large amounts of ketones in the urine. Ketones are produced when the body burns fat for energy instead of glucose.

If you have any of these symptoms and high blood sugar seek immediate medical attention.
See the paragraph “If you forget to take Lyumjev”.

Illnesses
If you have an illness, especially if you feel sick or unwell, your insulin needs may change.

Even when you are not eating normally, you still need insulin.Check
your urine and blood, follow the precautions you already know when you are sick, and tell your doctor.

5. How to store Lyumjev KwikPen

Before first use
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep in the original package to protect from light.

After first use
Do not store at a temperature above 30 °C.
Do not freeze.
Do not refrigerate.
The KwikPen must not be stored with the needle attached. Keep the cap on the pen to
protect from light.
Dispose of after 28 days even if some of the solution remains.
Do not dispose of any medicine in 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 Lyumjev 100 units/mL KwikPen injectable solution contains

The active ingredient is insulin lispro. Each mL of solution contains 100 units of insulin lispro. One KwikPen contains 300 units of insulin lispro in 3 mL of solution.
The excipients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, sodium treprostinil, zinc oxide, water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH (see at the end of paragraph 2 under “Lyumjev KwikPen contains sodium”).

Description of the appearance of Lyumjev KwikPen and contents of the pack
Lyumjev KwikPen, injectable solution is a clear, colorless aqueous solution contained in a
prefilled pen. Each prefilled pen contains 300 units (3 milliliters).
Packs of 2, 5 or multi-pack of 2 x 5 prefilled pens.
Not all pack sizes may be marketed.
Lyumjev KwikPen is taupe colored. The dose selector button is blue with raised markings on the side.
The label is blue and white.
Each Lyumjev KwikPen delivers from 1 to 60 units in 1-unit increments in a single
injection.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France
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 "Eli Lilly Nederland" B.V. - България
T ел.: + 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
Dista 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
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

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu .

Instructions for use

Lyumjev 100 units/mL KwikPen injectable solution in prefilled pen

insulin lispro

Disposable pen injector with a blue protective cap and a white section for dose display

READ THESE INSTRUCTIONS BEFORE USE
Read the instructions for use before using Lyumjev and each time you need to use another
Lyumjev KwikPen. There may be new information. This information does not replace
consultation with healthcare professionals regarding the clinical condition or treatment.

Do not share your Lyumjev KwikPen with others, even if the needle has been changed. Do not
reuse needles or share them with others. This could cause a serious infection in others or give you a serious infection from them.
Lyumjev 100 units/mL KwikPen (“Pen”) is a disposable prefilled pen containing 3 mL
(300 units, 100 units/mL) of insulin lispro injectable solution.

Healthcare professionals will tell you how many units to administer as a dose and how to inject the prescribed dose of insulin.
It is possible to administer more than 1 dose from the Pen.
Each rotation of the dose selector button selects 1 unit of insulin. You can inject from 1 to 60 units in a single injection.
If your dose is higher than 60 units, you will need to administer more than 1 injection. Always check the number in the dosage window to make sure you have selected the correct dose.
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. This pen should not be used by people who are blind or have poor
vision without the assistance of a person trained to use the Pen.

Components of the Lyumjev KwikPen
Pen Cap Cartridge Label
of the pen indicator dose

Components of a medical device: protective cap, transparent cylinder, screw mechanism and terminal blue part

Button
selector
of the
dose
Cap Clip
Rubber
closure
Plunger Pen Body Dosage
Window

Components of the Pen needle
(needles are not included)
Dose selector
button

Dark blue cylindrical plastic cap with rounded edge and smooth surface for medicinal vial

Components of a medical device: cylinder with tip, plunger, spring needle and transparent protective cap

Outer cap
of the needle
Inner
cap
of the needle Paper
needle protection

How to recognize Lyumjev KwikPen

Pen Color: Mole
Dose selector button: Blue, with raised markings on the side
Label: Blue and white

Materials needed to administer

Lyumjev KwikPen
Needle compatible with the KwikPen (BD [Becton, Dickinson and Company] pen needles are recommended)
Swab or gauze

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
Donot use the Pen after the expiration date printed on the label or for more than 28 days after the first use of the Pen.
Always use a newneedlefor each injection. This helps prevent infection and needle blockage.

Point 1: Remove the pen cap. Do not remove the pen label. Clean the rubber closure with a swab.	c o
Point 2: Check the appearance of the liquid in the Pen. Lyumjev should appear clear and colorless. Do not use it if it appears cloudy, colored, or if it contains particles or clumps.	m a
Point 3: Take a new needle. Remove the paper protection from the outer cap of the needle.	F a r
Point 4: Insert the needle covered by the cap straight onto the end of the Pen and rotate the needle until it is firmly attached.	d e l
a n Point 5: Remove the outer cap of the needle. Do not throw it away. Remove the inner cap of the needle and throw it away.	Hold Discard

Loading the Pen
Load before each injection.

Loading 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 notload before each injection, you may inject too much or too little insulin.

z Point 6: n

To load the Pen, select 2 units by rotating the dose selector button. e g

Glass vial with graduated scale and numbers 1 and 2, red arrow indicating the injection point

Point 7:

Hold the Pen with the needle pointing upwards. Tap the cartridge gently to collect the air on the surface.

c o

Hand gripping an injection pen device with visible needle and lateral graduated marking

Point 8:

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 you do not see insulin, repeat the loading operations from point 6 to 8, but no more than 4 times.
If you still do not see insulin, change the needle and repeat the loading operations from point 6 to 8. Small air bubbles are normal and do not interfere with the dosage.

d e l F a r m a
Hand holding an injection device with visible needle and magnification of the drug release mechanism with red indicator arrow

Scheme of an insulin pen with numeric indicator and dosage display window

Selecting the dose

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 1 injection.

If you need help dividing the dose correctly, ask healthcare professionals.
You must use a new needle for each new injection and repeat the loading operation.

Point 9:

Hand inserting a numbered cartridge 8 into a pen device with a red arrow indicating the direction

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 1 unit at a time.
The dose selector button clicks when you rotate it.

Scheme showing a medical device with two components connected by a diagonal line and numeric indication 12

Donot select the dose by counting the number of clicks. You may select the wrong dose. This could cause you to take too much or too little insulin. Example: 12 units displayed in the dosage window
The dose can be corrected by rotating the dose selector button in either direction until the correct dose is aligned with the dose indicator.

Scheme of a graduated cartridge with numeric indications 24, 26, 4, 6 and 8 on a graduated scale

The evennumbers are printed on the dial. The example on the right shows 12 units.
The oddnumbers after the number 1 are displayed as solid lines between the numbers. The example on the right shows 25 units.

Always check the number in the dosage window to make sure you have selected the correct dose.Example: 25 units displayed 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 administer 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.
Donot try to change the dose while you are administering the injection.

Point 10: Choose the injection site. Lyumjev is injected under the skin (subcutaneous injection) of the abdomen, buttocks, thighs, or upper arms. Clean the skin with a swab and wait for the skin to dry before injecting the dose.	m a c
Point 11: Insert the needle into the skin. Press the dose selector button all the way down. Continue to hold the dose selector button 5 sec and count slowly to 5 before 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.	a d e l F a r

Point 12:

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, this means you have administered the entire amount selected.
If you do not see “0” in the dosage window, this means you have not administered the entire dose. Do not reselect the dose. Insert the needle into the skin and finish your injection.
If you think you have not yet received the entire amount you selected for the injection, do not restart or repeat the injection. Check your blood glucose level as indicated by healthcare professionals. a
If you normally need 2 injections to administer the entire dose, make sure you n administer the second injection. 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, press lightly on the injection site with gauze or a swab. Do not rub the affected area.

d e l F a r m a c o
Scheme of an insulin pen with numeric indicator and dosage display window

After the injection

a Point 13: Carefully replace the outer cap on the needle.
e Point 14: g Unscrew the needle covered by the cap and dispose of it as described below (see section A “Disposal of the Pen and Needles”). Do not store the Pen with the needle inserted to prevent leaks, needle blockage and air entering the Pen.

Point 15:

Reposition the cap on the Pen holding it with the cap clip aligned with the dose indicator and press straight against the Pen.

c o

Pen for injection with protective needle sliding indicated by an orange arrow towards the pen body

Disposal of the Pen and Needles

Place used needles in a closable, puncture-resistant container or a hard plastic container with a secure lid. Do notdispose of needles directly into household waste containers.
Do notrecycle the container once it is filled with needles.
Ask healthcare professionals about the available options for appropriate disposal of the Pen and the container.
Instructions regarding needle handling should not replace local, institutional, or healthcare professional regulations.

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. For further information or if you have problems with Lyumjev 100 units/mL KwikPen, contact healthcare professionals for assistance or contact your local Eli Lilly branch.

Document revision date:

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Lyumjev 100 units/mL Junior KwikPen injectable solution in prefilled pen

insulin lispro

Each Junior KwikPen delivers from 0.5 to 30 units in 0.5 unit increments at a time in a single
injection.
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, pharmacist or nurse.
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, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Lyumjev Junior KwikPen is and what it is used for
2. What you need to know before you use Lyumjev Junior KwikPen
3. How to use Lyumjev Junior KwikPen
4. Possible side effects
5. How to store Lyumjev Junior KwikPen
6. Contents of the pack and other information

1. What is Lyumjev Junior KwikPen and what it is used for

Lyumjev 100 units/mL Junior KwikPen injectable solution in a pre-filled pen contains the active substance insulin lispro. Lyumjev is used for the therapy of diabetes mellitus in adults, adolescents and children aged 1 year and over. It is a prandial insulin that acts more quickly than other medicines containing insulin lispro. Lyumjev contains components that accelerate the absorption of insulin lispro into the body.
Diabetes is a condition in which the body does not produce enough insulin or does not use insulin effectively, which results in effects such as high blood sugar levels. Lyumjev is an insulin-based medicine used in the treatment of diabetes and therefore controls blood sugar. Effective diabetes treatment, with good blood sugar control, prevents long-term complications of diabetes.
Treatment with Lyumjev helps to control long-term blood sugar and prevent complications of diabetes. Lyumjev exerts its maximum effect 1 to 3 hours after injection and this effect lasts up to 5 hours. You should use Lyumjev at the beginning of the meal or up to 20 minutes after starting the meal.
The doctor may prescribe you both the use of Lyumjev and a long- or intermediate-acting insulin. Do not change the type of insulin unless prescribed by your doctor.
Lyumjev 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 using Lyumjev Junior KwikPen

DO NOT use Lyumjev Junior KwikPen

if you think your blood sugar level is falling (hypoglycemia). Further on, this leaflet explains how to treat low blood sugar (see section 3 under “If you use more Lyumjev than you should”).
if you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Lyumjev.
If you cannot see very well, you will need the help of someone who has been trained to give
injections.

Low blood sugar(hypoglycemia) Low blood sugar can be serious and untreated hypoglycemia can even lead to death. Lyumjev starts to lower blood sugar faster than other prandial insulins. Hypoglycemia may occur earlier after an injection of Lyumjev. If you often have hypoglycemia or have difficulty recognizing it, talk to your doctor or nurse. If your blood sugar is well controlled by the insulin therapy you are taking or if you have had diabetes for a long time, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. For symptoms, see "Common diabetes problems".

You must pay close attention to the timing of meals, frequency and intensity of physical exercise.
You should also monitor your blood sugar levels frequently.
Making changes to the types of insulin you use can cause excessive increases or decreases
in blood sugar levels.
You may need to increase the frequency of blood sugar checks if you are at risk of low
blood sugar levels. Your doctor may need to adjust the doses of your other diabetes medications.

High blood sugar(hyperglycemia) Stopping or taking insufficient insulin can cause high blood sugar (hyperglycemia) and diabetic ketoacidosis, serious conditions that can even lead to death. For symptoms, see "Common diabetes problems".
If insulin treatment is combined with one of a class of diabetes medicines called thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling caused by fluid retention (edema).
If you experience a severe allergic reaction to insulin or any of the components of Lyumjev, stop using this medicine and contact emergency medical services immediately.
Always check the package and label for the name and type of insulin you are given by the pharmacist. Make sure your Lyumjev package matches the one prescribed by your doctor.
Keep the package or note the batch number on the package. If you experience an adverse effect, you can provide this number when reporting the adverse effect, see "Reporting of adverse effects".
Always use a new needle for each injection to prevent infections and needle blockage. If a needle is blocked, replace it with a new needle.
Skin changes at the injection siteThe 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 “How to use Lyumjev Junior KwikPen”). If you are currently injecting into an area with nodules, consult your doctor before starting to inject into another area. Your doctor may ask you to check your blood sugar more carefully and adjust your insulin or other diabetes medications.

Children and adolescents
This medicine is not recommended for use in children under 1 year of age.

other diabetes medicines (oral and injectable)
sulfonamide antibiotics (for infections)
acetylsalicylic acid (for mild pain and fever and to prevent blood clotting)
some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors)
some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) (for some heart problems or high blood pressure)
angiotensin II receptor blockers (for high blood pressure or heart problems)
somatostatin analogues (such as octreotide, used to treat a rare disease characterized by excessive production of growth hormone).

Blood sugar levels may increase (hyperglycemia) if you take:

danazol (for endometriosis)
the contraceptive pill (birth control pills)
thyroid hormone replacement therapy (for thyroid problems)
human growth hormone (for growth hormone deficiency)
diuretics (for high blood pressure or fluid retention)
sympathomimetic agents (for severe allergic reactions or used in some cold remedies)
corticosteroids (to treat asthma or autoimmune diseases)

Beta-blockers (used for hypertension, arrhythmia or angina) make it more difficult to recognize the signs
of low blood sugar.

Pregnancy and breastfeeding
If you are planning a pregnancy, suspect you are pregnant, are pregnant or are
breastfeeding, ask your doctor, pharmacist or nurse for advice before
taking this medicine. The amount of insulin you need generally decreases during
the first 3 months of pregnancy and increases during the remaining 6 months. After giving birth, your insulin needs will likely return to your pre-pregnancy needs.
There are no restrictions on the use of Lyumjev during breastfeeding. If you are breastfeeding, you
may need to adjust the amount of insulin you are taking or your diet.

frequent episodes of hypoglycemia
reduced or absent warning signs of hypoglycemia.

Lyumjev Junior KwikPen 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 Lyumjev Junior KwikPen

or following the instructions of your doctor, pharmacist or nurse. If you have any doubts, consult your doctor, the
pharmacist or the nurse.
Your doctor, pharmacist or nurse will tell you exactly how much Lyumjev to use, when to use it and
how often. They will also tell you how often to visit the diabetes center.
To prevent possible transmission of diseases, each pen must be used only by you, even if
the needle is changed.
You should always have a reserve of insulin and another injection device with you in case you need it.
If you are blind or visually impaired, you will need someone's help to perform the injections.
Your doctor may tell you to use both Lyumjev and a longer- or intermediate-acting insulin. These must
be injected separately. Lyumjev must not be mixed with any other insulin.

When to inject Lyumjev
Lyumjev is a prandial insulin. You should use Lyumjev when you start to eat, or one or two minutes
before the meal; you can also choose to inject the medicine up to 20 minutes after the start of the meal.

How much insulin to use
Your doctor will determine the dose based on your blood sugar and body weight and will explain to you:

how much Lyumjev you need with each meal;
how and when to check your blood sugar level;
how to adjust the insulin dose based on blood sugar levels;
what to do if you change your diet or change the amount of physical activity, if you are sick or if you use other medicines;
if you change the type of insulin you are using, you may need to take more or less of it than before. This may be necessary only for the first injection or may be a gradual change over several weeks or months.

Do not use Lyumjev

If it does not look like water. Lyumjev must be clear, colorless and free of solid particles. Check all of this before each injection.
If Lyumjev has not been stored correctly (see section 5 "How to store Lyumjev").
If any part of the pen appears damaged, do not use.

Preparing the Lyumjev Junior KwikPen to make it ready for use (see the instructions
for use)

First, wash your hands.
Read the instructions on how to use your prefilled insulin pen. Follow the instructions scrupulously. Below are some important points.
Use a new needle (needles are not included in the package).
Prime the Lyumjev Junior KwikPen each time before use. This allows you to check that the insulin is flowing and to eliminate air bubbles from the Lyumjev Junior KwikPen. Some small air bubbles may remain in the pen. Small air bubbles are normal and do not affect the dose to be injected.
The number of units is displayed in the dosage window, always check it before the injection.

Injecting Lyumjev

Before giving the injection, disinfect the skin.
Inject the medicine under the skin (subcutaneous injection), as you have been taught by your doctor or nurse.
After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Make sure to inject at least 1 cm away from the last injection and to "rotate" the injection areas (arm, thigh, buttocks or abdomen).
If there is not enough insulin in the pen to complete the dose, note how much more you need. Load a new pen and inject the remaining dose.
If you need to inject another insulin at the same time as Lyumjev, use a different injection site.
Do not inject the medicine directly into a vein.

After the injection

As soon as you have finished the injection, remove the needle from the Lyumjev Junior KwikPen using the outer needle cap. This will help keep the insulin sterile and prevent medicine from leaking. It will also stop air from entering the pen and obstructing the needle. Do not share your needles with other people. Do not share yourpen with other people.Replace the cap on the pen.
If you are unsure how much medicine you have injected, check your blood sugar levels before deciding if you need another injection.

Subsequent injections

Each time you use a Lyumjev 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 pen by holding the Lyumjev Junior KwikPen upright, with the needle pointing upwards.
Once the Lyumjev Junior KwikPen is empty, do not reuse it.

If you use more Lyumjev than you should
If you have injected too much Lyumjev, or are unsure 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 (hypoglycemia )and you are able to treat it yourself, eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits or a
sandwich, as suggested by your doctor or nurse and rest. This is often enough to
counteract mild hypoglycemia or a moderate overdose of insulin. Check your blood sugar again after 15-20 minutes until your blood sugar has stabilized.
If you are unable to take care of yourself (severe hypoglycemia) because you feel dizzy, weak,
confused, have difficulty speaking, lose consciousness or have convulsions, you may need to be treated with glucagon. Glucagon can be administered by someone who knows how to use it.
Eat glucose or sugar after glucagon. If glucagon does not work, you will need to go to the hospital or
call emergency services. Ask your doctor for information about glucagon.
Tell everyone you spend time with that you have diabetes. Tell them what could
happen if your blood sugar drops too low, including the risk of fainting.
Tell them that if you were to faint, they should: turn you on your side to prevent choking, ask
for immediate medical assistance and do not try to give you food or drink because you could choke.

If you forget to use Lyumjev
If you forget to use the insulin or use less than you should, or are unsure how much you have injected, your
blood sugar may become too high (hyperglycemia). Check your blood sugar level to
decide if you need an insulin dose. Resume your usual dosing schedule at the next meal.

Three simple precautionsto reduce the risk of hypoglycemia or hyperglycemia:

always keep a spare pen, in case you lose your Lyumjev Junior KwikPen or it is damaged;
always carry a document indicating that you have diabetes;
always carry sugar with you.

If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

immediatelyto raise your blood sugar level. See paragraph 3 "If you use more
Lyumjev than you should".
Allergic reactionsare common (may affect up to 1 in 10 people). They can be serious
and may include the following symptoms:
skin rash and feeling of
itching all over the body
difficulty breathing
wheezing
low blood pressure
fast heartbeat
sweating

In case of a severe allergic reaction(including anaphylactic shock) to insulin or any
of the excipients of Lyumjev, stop using this medicine and contact the emergency medical
service immediately.

Other side effects include
Common(may affect up to 1 in 10 people)
Reactions at the injection site. Some people experience redness, pain, swelling or itching
in the area of insulin injection. This usually resolves within a few minutes or weeks
without the need to stop Lyumjev. Tell your doctor if you have injection site reactions.

Uncommon(may affect up to 1 in 100 people)
Changes in the skin at the injection site: if you inject insulin too often in the same place, the
fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy). Lumps under the skin may
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.

Other potential side effects
Swelling of the arms or ankles due to fluid retention (edema), especially at the beginning
of insulin therapy or during a change in diabetes medications.

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 listed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

Common diabetes problems
Low blood sugar level
A low blood sugar level (hypoglycemia) indicates that there is not enough sugar in
the blood. It can occur if:

you take too much Lyumjev or another insulin;
you delay or miss a meal, or if you change your diet;
you do strenuous physical activity immediately before or after a meal;
you have an infection or other illness (especially diarrhea or vomiting);
there is a change in your insulin needs, for example if you lose weight, or if a pre-existing kidney or liver disorder worsens. See the paragraph "If you use more Lyumjev than you should".

Usually, the first symptoms of hypoglycemia come on quickly and include:

tiredness
fast heartbeat
nervousness or agitation
feeling unwell
headache
cold sweat.

If you are unable to recognise the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, in which hypoglycemia could put you or others at risk.

not taking enough insulin;
using less insulin than you need;
an imbalance between the amount of carbohydrates you eat and the insulin you take; or
fever, infection or strong emotion.

The first symptoms of hyperglycemia are:

feeling very thirsty
headache
feeling sleepy
increased need to urinate.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. Further symptoms include:

nausea and/or vomiting
abdominal pain
rapid breathing
heavy breathing
moderate or large amounts of ketones in the urine. Ketones are produced when the body burns fat for energy instead of glucose.

If you have any of these symptoms and high blood sugar seek immediate medical attention.
See the paragraph “If you forget to take Lyumjev”.

Illnesses
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, follow the precautions you already know when you are ill and tell your doctor.

5. How to store Lyumjev Junior KwikPen

Keep this medicine 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 in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep in the original package to protect from light.

After first use
Do not store at a temperature above 30 °C.
Do not freeze.
Do not refrigerate.
The Lyumjev Junior KwikPen must not be stored with the needle attached. Keep the cap on the
pen to protect from light.
Dispose of after 28 days even if some of the solution remains.
Do not dispose of any medicine in 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 Lyumjev 100 units/mL Junior KwikPen injectable solution contains

The active ingredient is insulin lispro. Each mL of solution contains 100 units of insulin lispro. One Lyumjev Junior KwikPen contains 300 units of insulin lispro in 3 mL of solution.
The excipients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, sodium treprostinil, zinc oxide, water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH (see at the end of paragraph 2 under “Lyumjev Junior KwikPen contains sodium”).

Description of the appearance of Lyumjev 100 units/mL Junior KwikPen and contents of the pack
Lyumjev 100 units/mL Junior KwikPen, injectable solution is an aqueous, clear,
colourless solution contained in a prefilled pen.
Each prefilled pen contains 300 units (3 millilitres).
Packs of 2, 5 or multi-pack of 2 x 5 prefilled pens.
Not all pack sizes may be marketed.
Lyumjev Junior KwikPen is taupe coloured. The dose selector button is peach coloured with raised
marks on the bottom and side. The label is white with a peach strip and a band of peach, light blue
and dark blue.
Each Lyumjev Junior KwikPen delivers from 0.5 to 30 units in increments of 0.5 units at a time in a
single injection.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Manufacturer
Lilly France
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
ТП "Ели Лили Недерланд" Б.В. - България
T ел.: + 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
Dista 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
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

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu.

Instructions for use

Lyumjev 100 units/mL Junior KwikPen injectable solution in prefilled pen

insulin lispro

Pen disassembled with protective needle and orange cap separated from the main body

READ THESE INSTRUCTIONS BEFORE USE
Read the instructions for use before using Lyumjev and each time you need to use another
Lyumjev Junior KwikPen. There may be new information. This information does not
replace discussion with healthcare professionals regarding your medical condition or treatment.

Do not share your Lyumjev Junior KwikPen with others, even if the needle has been changed.
Do not reuse needles or share them with others. This could cause a serious infection to
others or give you a serious infection from them.
Lyumjev 100 units/mL Junior KwikPen (“Pen”) is a disposable prefilled pen containing 3 mL
(300 units, 100 units/mL) of insulin lispro injectable solution.

Healthcare professionals will tell you how many units to administer as a dose and how to inject the prescribed dose of insulin.
You can administer more than 1 dose from the Pen.
Each rotation of the dose selector button selects half (0.5) a unit of insulin. You can inject from half (0.5 units) to 30 units in a single injection.
If your dose is greater than 30 units, you will need to administer more than 1 injection. Always check the number in the dosage window to make sure you have selected the correct dose.
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. This pen should not be used by people who are blind or have difficultyseeing without the assistance of a person trained to use the Pen.

Components of the Lyumjev Junior KwikPen
Pen
Cap
Cartridge
Label Dose
Indicator

Syringe disassembled with brown plunger, transparent cylindrical body and metal needle with protective cap

Button
selector
of the
dose
Clip of the Plunger Pen Body
Cap
rubber dosage
window

Components of the Pen needle
(needles are not included)
Dose selector
button

Light brown cylindrical cap with radial grooves and central hole for medicinal vial

Components of a medical device: cylinder with tip, plunger, spring needle and protective cap

Outer
needle
cap
Inner
needle
cap Paper
protection

How to recognize Lyumjev Junior KwikPen

Pen Color: Mole
Color of the dose selector button: Peach, with raised lines on the bottom and side
Label: White with a peach stripe and a peach, light blue and dark blue band.

Materials needed to administer

Lyumjev Junior KwikPen
Needle compatible with the KwikPen (BD [Becton, Dickinson and Company] pen needles are recommended)
Swab or gauze

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.
Donot use 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 newneedlefor each injection to help prevent infection and needle blockage.

a Step 1: t

Remove the Pen cap. I

Do not remove the Pen label.

Clean the rubber closure with a swab. a

Syringe with needle facing down and red arrow indicating the direction of insertion

i Step 2: z

Check the appearance of the liquid in the Pen.
Lyumjev should appear clear and colorless. n Do not use it if it appears cloudy, colored, or if it contains particles or clumps.

e Step 3: g

Take a new needle.
Remove the paper protection from the outer A needle cap.

Hand rotating a protective cap on a medical device with a red arrow indicating the movement

Step 4: Insert the needle covered by the cap straight onto the end of the Pen and rotate the needle until it is firmly attached.	c o
Step 5: Remove the outer needle cap. Do not throw it away. Remove the inner needle cap and throw it away.	a m r Hold Dispose of

Loading the Pen
Load the Pen before each injection.

Loading 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 notload before each injection, you may inject too much or too little insulin.

Step 6:

To load the Pen, select 2 units by rotating the dose selector button.

a r m a

Glass vial with graduated scale and partial plunger, red arrow indicates the direction of extraction

Hand holding an injection pen device with exposed needle and graduated dosage markings

Step 7:

Hold the Pen with the needle pointing up. Tap the cartridge gently to collect air on the surface.

e l F

Hand holding an injection pen with visible needle and detailed enlargement of the dosing mechanism with red arrow indicating the direction

Step 8:

Continue to hold the Pen with the needle pointing a up. 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 not appear, repeat the loading operations from step 6 to 8, but no more than 4 times. If insulin still does not appear, change the needle and repeat the loading operations from step 6 to 8. Small air bubbles are normal and do not interfere with dosing.

Automatic injection device with graduated scale from 0 to 1 and indication 0.5, rounded shape and visible cross-section

Selecting the dose

You can administer from half a unit (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 1 injection.

If you need help dividing the dose correctly, ask healthcare professionals.
You must use a newneedlefor each new injection and repeat the loading operation.
If your insulin needs are usually greater than 30 units, ask healthcare professionals if another Lyumjev KwikPen is better for you.

Step 9:

Injectable pen with graduated scale from 8 to 9 and red arrow indicating the removal of the protective cap

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 half a unit (0.5 units) at a time.
The dose selector button clicks when you rotate it.

Prefilled injectable pen with graduated scale from 3 to 5 and partial plunger visible

Do notselect the dose by counting the number of clicks. You may select the wrong dose. This could cause you to take too much or too little insulin. Example: 4 units shown in the dosage window
The dose can be corrected by rotating the dose selector button in either direction until the correct dose is aligned with the dose indicator.

Graduated syringe with scale from 0 to 11 units, indications 05 and 10 visible, white plunger and cylindrical body on a curved background

The numbers corresponding to whole unitsare printed on the dial. The example on the right shows 4 units.
Half unitsare displayed as lines between the whole unit numbers. The example on the right shows 10.5 units.

Always check the number in the dosage windowto make sure you haveselected the correct dose.Example: 10 and a half units (10.5) 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 administer 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 you are making the injection.

Step 10: Choose the injection site. Lyumjev is injected under the skin (subcutaneous injection) of the abdominal area, buttocks, thighs, or upper arms. Clean the skin with a swab and wait for the skin to dry before injecting the dose.	F a r m a c
Step 11: Insert the needle into the skin. Press the dose selector button all the way down. Continue to hold the dose selector button 5 sec and count slowly to 5 before 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.	a d e l

Step 12:

Remove the needle from the skin.

A drop of insulin remaining on the tip of the needle is normal. It will have no effect on 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 amount selected.
If you do not see “0” in the dosage window, it means you have not administered the entire dose. Do not reselect the dose. Insert the needle into the skin and finish your injection.
If you think you have not yet received the entire amount you have selected for the injection, do not restart or repeat the injection. Check your blood glucose level as directed by healthcare professionals.

a d e l F a r m a c
Scheme of a cartridge with measurement indications in millimeters and numbers 05 and 1 visible

After the injection
Disposing of the Pen and needles

Place used needles in a closable container specifically for sharps or hard plastic with a secure lid. Do notthrow needles directly into household waste.
Do notrecycle the container once it is filled with needles.
Ask healthcare professionals for options for proper disposal of the Pen and such container.
Instructions regarding needle handling should not replace local, institutional or healthcare professional regulations.

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.

For further information or if you have problems with Lyumjev 100 units/mL Junior KwikPen, contact your
healthcare professional for assistance or contact your local Eli Lilly branch.
Document revision date:

Point 13: Carefully replace the outer cap on the needle.	a c o
Point 14: Unscrew the needle covered by the cap and dispose of it as described below (see the paragraph “Disposal of the Pen and needles”). Do not store the Pen with the needle inserted to prevent leakage, needle blockage and air entering the Pen.	F a r m
Point 15: Reposition the cap on the Pen, holding it with the cap clip aligned with the dose indicator and press straight relative to the Pen.	d e l

Lyumjev 100 units/mL Tempo Pen prefilled pen solution for injection

insulin lispro

Each Tempo Pen delivers from 1 to 60 units in 1-unit increments in a single
injection.
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, pharmacist or nurse.
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, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Lyumjev Tempo Pen is and what it is used for
2. What you need to know before you use Lyumjev Tempo Pen
3. How to use Lyumjev Tempo Pen
4. Possible side effects
5. How to store Lyumjev Tempo Pen
6. Contents of the pack and other information

1. What is Lyumjev Tempo Pen and what is it used for

Lyumjev 100 units/mL Tempo Pen pre-filled pen injectable solution contains the active ingredient
insulin lispro. Lyumjev is used for the therapy of diabetes mellitus in adults, adolescents and
children aged 1 year or younger. It is a prandial insulin that acts more rapidly than other
medicines containing insulin lispro. Lyumjev contains components that accelerate the absorption
of insulin lispro in the body.
Diabetes is a condition in which the body does not produce enough insulin or does not use
insulin effectively, which results in effects such as high blood sugar levels. Lyumjev is
an insulin-based medicine used in the treatment of diabetes and therefore controls blood
sugar. Effective diabetes treatment, with good blood sugar control, prevents
long-term complications of diabetes.
Treatment with Lyumjev helps to control blood glucose in the long term and to prevent the complications
of diabetes. Lyumjev exerts its maximum effect from 1 to 3 hours after injection and this effect lasts
up to 5 hours. You should use Lyumjev at the beginning of the meal or up to 20 minutes after the start of the meal.
The doctor may prescribe you to use both Lyumjev and a long- or intermediate-acting insulin.
Do not change the type of insulin unless prescribed by your doctor.
Lyumjev 100 units/mL 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 Lyumjev Tempo Pen

DO NOT use Lyumjev Tempo Pen

if you think your blood sugar level is falling (hypoglycemia). Further on, this leaflet explains how to treat low blood sugar (see section 3 under “If you use more Lyumjev than you should”).
if you are allergicto insulin lispro or any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Lyumjev.
If you cannot see very well, you will need the help of someone who has been trained to give
injections.

Low blood sugar(hypoglycemia) Low blood sugar can be serious and untreated hypoglycemia can even lead to death. Lyumjev starts to lower blood sugar faster than other prandial insulins. Hypoglycemia may occur earlier after an injection of Lyumjev. If you often experience hypoglycemia or have difficulty recognizing it, talk to your doctor or nurse. If your blood sugar is well controlled by the insulin therapy you are taking or if you have had diabetes for a long time, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. For symptoms, see "Common diabetes problems".

High blood sugar(hyperglycemia) Stopping or taking insufficient insulin can cause high blood sugar (hyperglycemia) and diabetic ketoacidosis, serious conditions that can even lead to death. For symptoms, see "Common diabetes problems".
If insulin treatment is combined with one of a class of diabetes medicines called thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling caused by fluid retention (edema).
If you experience a severe allergic reaction to insulin or any of the components of Lyumjev, stop using this medicine and contact emergency medical services immediately.
Always check the packaging and label for the name and type of insulin you are given by the pharmacist. Make sure your Lyumjev packaging matches what your doctor prescribed.
Keep the packaging or note the batch number on the packaging. If you experience an adverse reaction, you can provide this number when reporting the adverse reaction, see "Reporting of adverse reactions".
Always use a new needle for each injection to prevent infections and needle blockage. If a needle is blocked, replace it with a new needle.
Changes in the skin at the injection siteThe 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 into an area with nodules (see “How to use Lyumjev Tempo Pen”). 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 your insulin or other diabetes medications.

The Tempo Pen contains a magnet. If you have an implanted medical device, such as a
cardiac pacemaker, it may not function properly if the Tempo Pen is held too
close. The magnetic field extends approximately 1.5 cm.

Children and adolescents
This medicine is not recommended for use in children under 1 year of age.

other medicines for diabetes (oral and injectable)
sulfonamide antibiotics (for infections)
acetylsalicylic acid (for mild pain and fever and to prevent blood clotting)
some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors)
some angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) (for some heart problems or high blood pressure)
angiotensin II receptor blockers (for high blood pressure or heart problems)
somatostatin analogs (such as octreotide, used to treat a rare disease characterized by excessive growth hormone production).

Blood sugar levels may increase (hyperglycemia) if you take:

danazol (for endometriosis)
the contraceptive pill (birth control pills)
replacement thyroid hormone therapy (for thyroid problems)
human growth hormone (for growth hormone deficiency)
diuretics (for high blood pressure or fluid buildup in the body)
sympathomimetic agents (for severe allergic reactions or used in some cold remedies)
corticosteroids (to treat asthma or autoimmune diseases).

Beta-blockers (used for hypertension, arrhythmia or angina) make it more difficult to recognize the signs
of low blood sugar.

Pregnancy and breastfeeding
If you are planning a pregnancy, if you suspect you are pregnant, are pregnant or if you are
breastfeeding, ask your doctor, pharmacist or nurse for advice before
taking this medicine. The amount of insulin you need generally decreases during
the first 3 months of pregnancy and increases during the remaining 6 months. After giving birth, your insulin needs will likely return to your pre-pregnancy needs.
There are no restrictions on the use of Lyumjev during breastfeeding. If you are breastfeeding, you
may need to adjust the amount of insulin you are taking or your diet.

Driving and operating machinery
Your ability to concentrate and react may be reduced in case of hypoglycemia. Be aware
of this potential problem in all situations where you could put yourself or others
at risk (e.g. driving a vehicle or operating machinery). You should consult your doctor to
know if you can drive if you have:

frequent episodes of hypoglycemia
reduced or absent warning signs of hypoglycemia.

Lyumjev Tempo Pen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Lyumjev Tempo Pen

or following the instructions of your doctor, pharmacist or nurse. If you have any doubts, consult your doctor, your
pharmacist or your nurse.
Your doctor, pharmacist or nurse will tell you exactly how much Lyumjev to use, when to use it and
how often. They will also tell you how often to visit the diabetes center.
To prevent possible transmission of diseases, each pen must be used only by you, even if
the needle is changed.
You should always have spare insulin and another injection device with you in case you need it.
If you are blind or visually impaired, you will need someone's help to administer the injections.
Your doctor may tell you to use both Lyumjev and a longer- or intermediate-acting insulin. These must
be injected separately. Lyumjev must not be mixed with any other insulin.
The Tempo Pen is designed to work with the Tempo Smart Button. The optional
additional 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 further information, see the instructions provided with
the Tempo Smart Button and the mobile application.

When to inject Lyumjev
Lyumjev is a prandial insulin. You should use Lyumjev when you start to eat, or one or two minutes
before your meal; you can also choose to inject the medicine up to 20 minutes after starting your meal.

How much insulin to use
Your doctor will determine the dose based on your blood sugar and body weight and will explain to you:

how much Lyumjev you need with each meal;
how and when to check your blood sugar level;
how to adjust the insulin dose based on blood sugar levels;
what to do if you change your diet or change the amount of physical activity, if you are sick, or if you use other medicines;
if you change the type of insulin you are using, you may need to take more or less of it than before. This may be necessary only for the first injection or may be a gradual change over several weeks or months.

Do not use Lyumjev

If it does not look like water. Lyumjev must be clear, colorless and free of solid particles. Check this before every injection.
If Lyumjev has not been stored correctly (see section 5 "How to store Lyumjev").
If any part of the pen appears damaged, do not use.

Preparing the Tempo Pen to make it ready for use (see instructions for use)

First, wash your hands.
Read the instructions on how to use your prefilled insulin pen. Follow the instructions scrupulously. Below are some important points.
Use a new needle. (Needles are not included in the package).
Prime the Tempo Pen each time before use. This allows you to check that the insulin is flowing and to remove air bubbles from the Tempo Pen. Some small air bubbles may remain in the pen. Small air bubbles are normal and do not affect the dose to be injected.
The number of units is displayed in the dosage window, always check it before the injection.

Injecting Lyumjev

Before giving the injection, disinfect the skin.
Inject the medicine under the skin (subcutaneous injection), as you have been taught by your doctor or nurse.
After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Make sure to inject at least 1 cm away from the last injection and to "rotate" the injection sites (arm, thigh, buttocks or abdomen).
If there is not enough insulin in the pen to complete the dose, note how much more you need. Prime a new pen and inject the remaining dose.
If you need to inject another insulin at the same time as Lyumjev, use a different injection site.
Do not inject the medicine directly into a vein.

After the injection

As soon as you have finished the injection, remove the needle from the Tempo Pen using the outer needle cap. This will help keep the insulin sterile and prevent medicine from leaking. It will also stop air from entering the pen and blocking the needle. Do notshare your needles with other people. Do not share your pen with other people.Replace the cap on the pen.
If you are unsure how much medicine you have injected, check your blood sugar levels before deciding if you need another injection.

Subsequent injections

Each time you use a Tempo Pen you must use a new needle. Before each injection, remove any air bubbles. You can check how much insulin is left in the pen by holding the Tempo Pen upright, with the needle pointing upwards.
Once the Tempo Pen is empty, do not reuse it.

If you use more Lyumjev than you should
If you have injected too much Lyumjev, or are unsure how much you have injected, a decrease in blood sugar may occur. Check your blood sugar level.
If your blood sugar is low (hypoglycemia )and you are able to treat it yourself, eat glucose tablets, sugar or have a sugary drink. Then eat fruit, biscuits or a
sandwich, as suggested by your doctor or nurse and rest. This is often enough to counteract mild hypoglycemia or a moderate insulin overdose. Check your blood sugar again after 15-20 minutes until your blood sugar has stabilized.
If you are unable to take care of yourself (severe hypoglycemia) because you feel dizzy, weak,
confused, have difficulty speaking, lose consciousness or have convulsions, you may need to be treated with glucagon. Glucagon can be administered by someone who knows how to use it.
Eat glucose or sugar after glucagon. If glucagon does not work, you will need to go to hospital or
call emergency services. Ask your doctor about glucagon.
Tell everyone you spend time with that you have diabetes. Tell them what could
happen if your blood sugar gets too low, including the risk of fainting.
Tell them that if you were to faint, they should: turn you on your side to prevent choking, seek
immediate medical assistance and do not try to give you food or drink as you could choke.

If you forget to use Lyumjev
If you forget to use the insulin or use less than you should, or are unsure how much you have injected, your
blood sugar may get too high (hyperglycemia). Check your blood sugar level to
decide if you need an insulin dose. Resume your usual dosage schedule at the next meal.

Three simple precautionsto reduce the risk of hypoglycemia or hyperglycemia:

always keep a spare pen, in case you lose your Tempo Pen or it is damaged;
always carry a document indicating that you have diabetes;
always carry some sugar.

If you have any doubts about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A low blood sugar level (hypoglycemia)is very common during insulin treatment
(may affect more than 1 in 10 people). It can be very serious. If your blood sugar level
drops too low, you may lose consciousness. Severe hypoglycemia can cause damage to the brain and can
be life-threatening. If you have symptoms related to a low blood sugar level, act

immediatelyto raise your blood sugar level. See paragraph 3 "If you use more
Lyumjev than you should".
Allergic reactionsare common (may affect up to 1 in 10 people). They can be serious
and may include the following symptoms:
skin rash and sensation of
itching all over the body
low blood pressure
fast heartbeat
difficulty breathing
wheezing
sweating

In case of a severe allergic reaction(including anaphylactic shock) to insulin or any
of the excipients of Lyumjev, stop using this medicine and contact the emergency medical service immediately.

Other side effects include
Common(may affect up to 1 in 10 people)
Reactions at the injection site. Some people experience redness, pain, swelling or itching
in the insulin injection area. This usually resolves within minutes or a few weeks without
needing to stop Lyumjev. Tell your doctor if you have injection site reactions.

Uncommon(may affect up to 1 in 100)
Changes in the skin at the injection site: if you inject insulin too often in the same place, the
fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy). Lumps under the skin may
also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis).
Insulin may not work as well if you inject into an area with lumps.
Change the injection site with each injection to prevent these skin changes.

Other potential side effects
Swelling of the arms or ankles due to fluid retention (edema), especially at the beginning
of insulin therapy or during a change in diabetes medications.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
your national reporting system as detailed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

Common diabetes problems
Low blood sugar level
A low blood sugar level (hypoglycemia) means there is not enough sugar in
the blood. It can happen if:

you take too much Lyumjev or another insulin;
you delay or miss a meal or change your diet;
you do a lot of exercise or strenuous activity immediately before or after a meal;
you have an infection or other illness (especially diarrhea or vomiting);
there is a change in your insulin needs, for example if you lose weight, or if you have a worsening of existing kidney or liver problems. See the paragraph "If you use more Lyumjev than you should".

Di usually, the first symptoms of hypoglycemia come on quickly and include:

tiredness
fast heartbeat
nervousness or agitation
feeling unwell
headache
cold sweat.

If you are unable to recognise the warning signs of hypoglycemia, avoid situations, such as
driving, in which hypoglycemia could put you or others at risk.

High blood sugar level(hyperglycemia) and diabetic ketoacidosis
Hyperglycemia (too much sugar in the blood) means that the glucose levels in your body are
too high. Hyperglycemia can be caused by:

not taking enough insulin;
using less insulin than you need;
an imbalance between the amount of carbohydrates you eat and the insulin you take; or
fever, infection or a severe emotional shock.

The first symptoms of hyperglycemia are:

being very thirsty
headache
feeling sleepy
needing to urinate more often

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms develop slowly, over
many hours or days. Further symptoms include:

nausea and/or vomiting
stomach pain
rapid breathing
heavy breathing
moderate or large amounts of ketones in the urine. Ketones are produced when the body burns fat for energy instead of glucose.

If you have any of these symptoms and high blood sugar seek immediate medical attention.
See the paragraph “If you forget to take Lyumjev”.

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, follow the precautions you already know when you are ill and tell your doctor.

5. How to store Lyumjev Tempo Pen

Before first use
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep in the original package to protect from light.

After first use
Do not store at a temperature above 30 °C.
Do not freeze.
Do not refrigerate.
The Tempo Pen must not be stored with the needle attached. Keep the cap on the pen to
protect from light.
Dispose of after 28 days even if some solution remains.
Do not dispose of any medicine in waste water 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 Lyumjev 100 units/mL Tempo Pen injectable solution contains

The active ingredient is insulin lispro. Each mL of solution contains 100 units of insulin lispro. One Tempo Pen contains 300 units of insulin lispro in 3 mL of solution.
The excipients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, sodium treprostinil, zinc oxide, water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH (see at the end of paragraph 2 under “Lyumjev Tempo Pen contains sodium”).
The Tempo Pen contains a magnet (see paragraph 2, "Warnings and precautions").

Description of the appearance of Lyumjev Tempo Pen and contents of the pack
Lyumjev Tempo Pen, injectable solution is a clear, colourless aqueous solution contained in a
prefilled pen.
Each prefilled pen contains 300 units (3 millilitres).
Packs of 5 or multi-packs of 2 x 5 prefilled pens.
Not all pack sizes may be marketed.
Lyumjev Tempo Pen is taupe-coloured. The dose selector button is blue with raised markings along the
side. The label is blue, green and white.
Each Lyumjev Tempo Pen delivers from 1 to 60 units in 1-unit increments per single
injection.

Marketing Authorisation Holder
Eli Lilly Nederland B.V
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France
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
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.
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
Dista 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
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

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu .

Instructions for use

Lyumjev 100 units/mL Tempo Pen injectable solution in a prefilled pen

insulin lispro

Prefilled syringe with visible plunger and a blue safety cap protecting the needle

READ THESE INSTRUCTIONS BEFORE USE
Read the instructions for use before using Lyumjev and each time you need to use another
Lyumjev Tempo Pen. There may be new information. This information does not replace
discussion with healthcare professionals regarding your medical condition or treatment.
Lyumjev 100 units/mL Tempo Pen (“Pen”) is a disposable prefilled pen containing 3 mL
(300 units, 100 units/mL) of insulin lispro injectable solution.

Healthcare professionals will tell you how many units to administer as a dose and how to inject the prescribed dose of insulin.
You can administer more than 1 dose from the Pen.
Each rotation of the dose selector button selects 1 unit of insulin. You can inject from 1 to 60 units in a single injection.
If your dose is higher than 60 units, you will need to administer more than 1 injection. Always check the number in the dosage window to make sure you have selected the correct dose.
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.

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 Lyumjev 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 that the Smart
Button has snapped 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 the Lyumjev Tempo Pen with other people, even if the needle has been changed. Do not
reuse or share needles with other people. It could cause a serious infection in the person you lent it to or
cause you to contract a serious infection from the person you lent it to.
This pen should not be used by people who are blind or have visual impairments
without the assistance of a person trained to use the Pen.

Components of the Lyumjev Tempo Pen
Pen Cartridge Label Dose Indicator
Cap of the
Pen

Prefilled syringe with visible plunger, transparent cylinder, metal needle and blue protective cap

Clip of the Plunger Body of the Dose
Closure rubber Pen selector
Button
Window
cap

Components of the Pen Needle
(Needles are not included)
Dose selector
button

Dark blue cylindrical protective cap with vertical grooves and a small horizontal central slot

Outer Needle Inner Needle Paper
cap cap protection

How to recognize Lyumjev Tempo Pen:

Pen Color: Mole
Dose selector button: Blue, with raised markings along the side
Label: Blue, green and white Materials needed to perform the injection:
Lyumjev Tempo Pen
Needle compatible with the Tempo Pen (BD [Becton, Dickinson and Company] pen needles are recommended)
Swab or gauze

Needles, swabs or gauze 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 notuse the Pen after the expiration date printed on the label or for more than 28 days after the first use of the Pen.
Always use a new needlefor each injection to help prevent infections and needle blockages.

a Step 1: i

Remove the Pen cap. z

Do not remove the Pen label. n

Clean the rubber closure with a swab. e

Syringe with needle pointing downwards and red arrow indicating the direction of insertion

g Step 2:

Check the appearance of the liquid in the Pen. A
Lyumjev should appear clear and colorless. Do not use it if it appears cloudy, colored, or if it contains particles or clumps.

Step 3: Attach a new needle. Remove the paper protection from the outer needle cap	c o
Step 4: Insert the needle, covered by the cap, straight onto the end of the Pen and rotate the needle until it is firmly attached.	r m a
Step 5: Remove the outer needle cap. Do not throw it away. Remove the inner needle cap and throw it away.	a F l e Hold Discard

Priming the Pen
Prime 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.

i Step 6: l To prime the Pen, select 2 units by rotating the dose selector button. t I
Step 7: a Hold the Pen with the needle pointing up. Tap gently on the cartridge to collect the air on the surface. z
n Step 8: e Continue to hold the Pen with the needle pointing g up. 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 you do not see insulin, repeat the priming operations from step 6 to 8, but no more than 4 times.
If you still do not see insulin, change the needle and repeat the priming operations from step 6 to 8. Small air bubbles are normal and will not interfere with the dose.

a c o

Prefilled syringe with graduated scale and visible plunger all

Selecting the dose

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 1 injection.

If you need help dividing the dose correctly, ask healthcare professionals.
You must use a new needle for each new injection and repeat the priming operation.

Step 9:

Rotate the dose selector button to the number of units to inject. The dose indicator must be aligned with the dose.

Automatic injection device with graduated scale from 6 to 10 and red arrow indicating the dose adjustment

The Pen allows you to select 1 unit at a time.
The dose selector button clicks when you rotate it.

Automatic injection device with digital display showing the number 12 and a red arrow indicating the set dose

Do notselect the dose by counting the number of clicks. You could select the wrong dose. This could cause you to take too much or too little insulin. Example: 12 units shown in the dosage window
The dose can be corrected by rotating the dose selector button in either direction until the correct dose is aligned with the dose indicator.

Scheme of a graduated cartridge with numbers 24 26 and red arrow indicating the level of the graduated liquid on a numerical scale

The evennumbers are printed on the dial. The example on the right shows 12 units.
The oddnumbers, after the number 1, are displayed as solid lines between the numbers. The example on the right shows 25 units. Example: 25 units shown in the dosage window

Always check the number in the dosage window to make sure you haveselected the correct 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 administer 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 you are administering the injection.

Step 10: Choose the injection site. Lyumjev is injected under the skin (subcutaneous injection) of the abdominal area, buttocks, thighs, or upper arms. Clean the skin with a swab and wait for the skin to dry before injecting the dose. n	a d e l F
a Step 11: Insert the needle into the skin. i l Press the dose selector button all the way down. a Continue to hold the dose selector button 5 sec pressed and count slowly to 5 before removing the needle. Do not try to inject the insulin by rotating the t dose selector button. Rotating the dose selector button will not deliver your dose of insulin.

Step 12:

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, this means you have administered the entire amount selected.
If you do not see “0” in the dosage window, this means you have not administered the entire dose. Do not reselect the dose. Insert the needle into the skin and finish your injection.
If you think you have not yet received the entire amount you selected for the injection, do not restart or repeat the injection. Check your blood glucose level as directed by healthcare professionals. a
If you normally need 2 injections to administer the entire dose, make sure you administer the second injection. 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, press gently on the injection site with gauze or a swab. Do not rub the area.

Rectangular vial with gray upper rubber and upper part with numerical indication 5-0 and 1/2

After the injection
Disposal of the Pen and needles

Place used needles in a puncture-resistant or hard plastic container with a secure lid. Do notthrow the 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 Pen and such container.
Needle handling instructions should not replace local, institutional or healthcare professional regulations.

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 the 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 a prescription from your doctor.

For further information or if you have problems with Lyumjev 100 units/mL Tempo Pen, contact healthcare professionals for assistance or contact your local Eli Lilly branch.
Document revision date:

Point 13: Carefully replace the outer cap on the needle.	m a c o
Point 14: Unscrew the needle covered by the cap and dispose of it as described below (see the paragraph “Disposal of the Pen and needles”). Do not store the Pen with the needle inserted to prevent leakage, needle blockage and air entering the Pen.	l F a r
Point 15: Reposition the cap on the Pen holding it with the cap clip aligned with the dose indicator and press straight onto the Pen.	d e

Lyumjev 200 units/mL KwikPen pre-filled pen injectable solution

insulin lispro

Each KwikPen delivers from 1 to 60 units in one-unit increments in a single
injection.
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, pharmacist or nurse.
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, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Lyumjev 200 units/mL KwikPen is and what it is used for
2. What you need to know before you use Lyumjev 200 units/mL KwikPen
3. How to use Lyumjev 200 units/mL KwikPen
4. Possible side effects
5. How to store Lyumjev 200 units/mL KwikPen
6. Contents of the pack and other information

1. What is Lyumjev 200 units/mL KwikPen and what is it used for

Lyumjev 200 units/mL KwikPen injectable solution in a prefilled pen contains the active ingredient
insulin lispro. Lyumjev is used for the therapy of diabetes in adults. It is a prandial insulin that
acts more rapidly than other medicines containing insulin lispro. Lyumjev contains components that
accelerate the absorption of insulin lispro into the body.
Diabetes is a condition in which the body does not produce enough insulin or does not use
insulin effectively, which results in effects such as high blood sugar levels. Lyumjev is
an insulin-based medicine used in the treatment of diabetes and therefore controls blood sugar. Effective
diabetes treatment, with good blood sugar control, prevents
long-term complications of diabetes.
Treatment with Lyumjev helps to control blood glucose in the long term and to prevent complications
of diabetes. Lyumjev exerts its maximum effect from 1 to 3 hours after injection and this effect lasts
up to 5 hours. You should use Lyumjev at the beginning of the meal or up to 20 minutes after the start of the meal.
The doctor may prescribe both the use of Lyumjev and a long- or intermediate-acting insulin.
Do not change the type of insulin unless prescribed by your doctor.
Lyumjev 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 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 Lyumjev 200 units/mL KwikPen

DO NOT use Lyumjev 200 units/mL KwikPen

if you think your blood sugar is falling (hypoglycemia). Further on, this leaflet explains how to treat low blood sugar (see paragraph 3 under “If you use more Lyumjev than you should”).
if you are allergicto insulin lispro or any of the excipients of this medicine (listed in paragraph 6).

Warnings and precautions

Lyumjev 200 units/mL injectable solution in the prefilled pen (the KwikPen) must beinjected ONLY using this prefilled pen. Do not transfer insulin lispro fromLyumjev 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 may endanger your life. Do not transfer insulin from Lyumjev 200 units/mL KwikPen to any other insulin delivery device such as insulin infusion pumps.

Talk to your doctor, pharmacist or nurse before using Lyumjev.
If you cannot see very well, you will need the help of someone who has been trained to give
injections.

Low blood sugar(hypoglycemia) Low blood sugar can be serious, and untreated hypoglycemia can even lead to death. Lyumjev starts to lower blood sugar faster than other prandial insulins. Hypoglycemia may occur earlier after an injection of Lyumjev. If you often experience hypoglycemia or have difficulty recognizing it, talk to your doctor or nurse. If your blood sugar is well controlled by the insulin therapy you are taking or if you have had diabetes for a long time, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. For symptoms, see "Common diabetes problems".

You must pay close attention to the timing of meals, the frequency and intensity of physical exercise.
You should also monitor your blood sugar levels frequently.
Making changes to the types of insulin you use can cause excessive increases or decreases
in blood sugar levels.
You may need to increase the frequency of blood sugar checks if you are at risk of low
blood sugar levels. Your doctor may need to adjust the doses of your other diabetes medications.

High blood sugar(hyperglycemia) Stopping or taking insufficient insulin can cause high blood sugar (hyperglycemia) and diabetic ketoacidosis, serious conditions that can even lead to death. For symptoms, see "Common diabetes problems".
If insulin treatment is combined with one of a class of diabetes medicines called thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling caused by fluid retention (edema).
If you experience a severe allergic reaction to insulin or any of the components of Lyumjev, stop using this medicine and contact emergency medical services immediately.
Always check the packaging and label for the name and type of insulin you receive from the pharmacist. Make sure your Lyumjev packaging matches what your doctor has prescribed.
Keep the packaging or note the batch number on the packaging. If you experience an adverse reaction, you can provide this number when reporting the adverse reaction, see "Reporting of adverse reactions".
Always use a new needle for each injection to prevent infection and needle blockage. If a needle is blocked, replace it with a new needle.
Changes in skin at the injection siteThe 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 “How to use Lyumjev 200 units/mL 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 your insulin or other antidiabetic medications.

Children and adolescents
This medicine should not be used in children or adolescents, as there is no experience with
this medicine in children and adolescents under the age of 18.

Other medicines and Lyumjev
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or may
take any other medicines. Some medicines affect blood sugar levels;
this may mean that the dose of insulin needs to be adjusted.
Blood sugar levels may decrease (hypoglycemia) if you take:

other medicines for diabetes (oral and injectable)
sulfonamide antibiotics (for infections)
acetylsalicylic acid (for mild pain and fever and to prevent blood clotting)
some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors)
some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) (for some heart problems or high blood pressure)
angiotensin II receptor blockers (for high blood pressure or heart problems)
somatostatin analogs (such as octreotide, used to treat a rare disease characterized by excessive growth hormone production).

Blood sugar levels may increase (hyperglycemia) if you take:

danazol (for endometriosis)
the contraceptive pill (birth control pills)
replacement thyroid hormone therapy (for thyroid problems)
human growth hormone (for growth hormone deficiency)
diuretics (for high blood pressure or fluid retention)
sympathomimetic agents (for severe allergic reactions or used in some cold remedies)
corticosteroids (to treat asthma or autoimmune diseases).

Beta-blockers (used for hypertension, arrhythmia or angina) make it more difficult to recognize the signs
of low blood sugar.

Pregnancy and breastfeeding
If you are planning a pregnancy, if you suspect you are pregnant, are pregnant or if you are
breastfeeding, ask your doctor, pharmacist or nurse for advice before
taking this medicine. The amount of insulin you need generally decreases during the
first 3 months of pregnancy and increases during the remaining 6 months. After giving birth, your insulin needs will likely return to your needs before pregnancy.
There are no restrictions on the use of Lyumjev during breastfeeding. If you are breastfeeding, you
may need to adjust the amount of insulin you are taking or your diet.

Driving and operating machinery
Your ability to concentrate and react may be impaired in case of hypoglycemia. Be aware of
this potential problem 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 to
find out if you can drive if you have:

frequent episodes of hypoglycemia
reduced or absent warning signs of hypoglycemia.

Lyumjev 200 units/mL KwikPen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.

3. How to use Lyumjev 200 units/mL KwikPen

or following the instructions of your doctor, pharmacist or nurse. If you have any doubts, consult your doctor, pharmacist or nurse.
Your doctor, pharmacist or nurse will tell you exactly how much Lyumjev to use, when to use it and
how often. They will also tell you how often to visit the diabetes center.
To prevent possible transmission of diseases, each pen must be used only by you, even if
the needle is changed.
Do not use Lyumjev 200 units/mL KwikPen injectable solution in an insulin microinfusor.
You should always have spare insulin and another injection device with you in case you need it.
If you are blind or have low vision, you will need someone's help to administer the injections.
Your doctor may tell you to use both Lyumjev and a longer- or intermediate-acting insulin. These must
be injected separately. Lyumjev should not be mixed with any other insulin.

When to inject Lyumjev
Lyumjev is a prandial insulin. You should use Lyumjev when you start eating, or one or two
minutes before your meal; you can also choose to inject the medicine up to 20 minutes after starting your meal.

How much insulin to use
Your doctor will determine the dose based on your blood sugar and body weight and will explain to you:

how much Lyumjev you need with each meal;
how and when to check your blood sugar level;
how to adjust the insulin dose based on blood sugar levels;
what to do if you change your diet or change the amount of physical activity, if you are sick or if you are using other medicines;
if you change the type of insulin you are using, you may need to take more or less of it than before. This may be necessary only for the first injection or may be a gradual change over several weeks or months.

Do not use Lyumjev

If it does not look like water. Lyumjev must be clear, colorless and free of solid particles. Check this before each injection.
If Lyumjev has not been stored correctly (see section 5 "How to store Lyumjev").
If any part of the pen appears damaged, do not use.

Preparing the Lyumjev 200 units/mL KwikPen to make it ready for use (see
instructions for use)

First, wash your hands.
Read the instructions on how to use your prefilled insulin pen. Follow the instructions carefully. Below are some important points.
Use a new needle (needles are not included in the package).
Prime the Lyumjev 200 units/mL KwikPen each time before use. This allows you to check that the insulin is flowing and to remove air bubbles from the Lyumjev 200 units/mL KwikPen. Some small air bubbles may remain in the pen. Small air bubbles are normal and do not affect the dose to be injected.
The number of units is displayed in the dosage window, always check it before injection.

Injecting Lyumjev

Before giving the injection, disinfect the skin.
Inject the medicine under the skin (subcutaneous injection), as you have been taught by your doctor or nurse.
After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Make sure to inject at least 1 cm away from the last injection and to "rotate" the injection sites (arm, thigh, buttocks or abdomen.
If there is not enough insulin in the pen to complete the dose, note how much more you need to take. Prime a new pen and inject the remaining dose.
If you need to inject another insulin at the same time as Lyumjev, use a different injection site.
Do not inject the medicine directly into a vein.

After the injection

As soon as you have finished the injection, remove the needle from the Lyumjev 200 units/mL KwikPen using the outer needle cap. This will allow you to keep the insulin sterile and prevent medicine from leaking. It will also stop air from entering the pen and blocking the needle. Do not share your needles with other people. Do not share your pen with otherpeople.Replace the cap on the pen.
If you are unsure how much medicine you have injected, check your blood sugar levels before deciding if you need another injection.

Subsequent injections

Each time you use a Lyumjev 200 units/mL KwikPen you must use a new needle. Before each injection, remove any air bubbles. You can make sure how much insulin is left in the pen by holding the Lyumjev 200 units/mL KwikPen upright, with the needle pointing upwards.
Once the Lyumjev 200 units/mL KwikPen is empty, do not reuse it.

If you use more Lyumjev than you should
If you have injected too much Lyumjev, or are unsure 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 (hypoglycemia )and you are able to treat it yourself, eat glucose tablets, sugar or have a sugary drink. Then eat fruit, biscuits or a
sandwich, as suggested by your doctor or nurse and rest. This is often enough to
counteract mild hypoglycemia or a moderate overdose of insulin. Check your blood sugar again after 15-20 minutes until your blood sugar has stabilized.
If you are unable to take care of yourself (severe hypoglycemia) because you feel dizzy, weak,
confused, have difficulty speaking, lose consciousness or have convulsions, you may need to be
treated with glucagon. Glucagon can be administered by someone who knows how to use it. Eat
glucose or sugar after glucagon. If glucagon does not work, you will need to go to hospital or
call emergency services. Ask your doctor about glucagon.
Tell everyone you spend time with that you have diabetes. Tell them what might
happen if your blood sugar gets too low, including the risk of fainting.
Tell them that if you were to faint, they should: turn you on your side to prevent choking, ask
for immediate medical assistance and do not try to give you food or drink as you could choke.

If you forget to use Lyumjev
If you forget to use the insulin or use less than you should, or are unsure how much you have injected, your
blood sugar may become too high (hyperglycemia). Check your blood sugar level to
decide if an insulin dose is needed. Resume your usual dosing schedule at the next meal.

Three simple precautionsto reduce the risk of hypoglycemia or hyperglycemia:

always have a spare pen, in case you lose your Lyumjev 200 units/mL KwikPen or it is damaged;
always carry a document indicating that you have diabetes;
always carry sugar with you.

If you have any doubts about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A low blood sugar level (hypoglycemia)is very common during insulin treatment
(may affect more than 1 in 10 people). It can be very serious. If your blood sugar level
drops too low, you may lose consciousness. Severe hypoglycemia can cause damage to the brain and can
be life-threatening. If you have symptoms related to a low blood sugar level, act

immediatelyto raise your blood sugar level. See section 3 "If you use more
Lyumjev than you should".
Allergic reactionsare common (may affect up to 1 in 10 people). They can be serious
and may include the following symptoms:
skin rash and feeling of
itching all over the body
difficulty breathing
wheezing
low blood pressure
fast heartbeat
sweating

In case of a severe allergic reaction(including anaphylactic shock) to insulin or any
of the excipients of Lyumjev, stop using this medicine and contact the emergency medical service immediately.

Other side effects include
Common(may affect up to 1 in 10 people)
Reactions at the injection site. Some people experience redness, pain, swelling, or itching
in the area of insulin injection. This usually resolves within a few minutes or weeks without
the need to stop Lyumjev. Tell your doctor if you have injection site reactions.

Uncommon(may affect up to 1 in 100)
Changes in the skin at the injection site: if you inject insulin too often in the same place, the
fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy). Lumps under the skin may
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.

Other potential side effects
Swelling of the arms or ankles due to fluid retention (edema), especially at the beginning
of insulin therapy or during a change in diabetes medications.

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 listed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

Common diabetes problems
Low blood sugar
A low blood sugar level (hypoglycemia) indicates that there is not enough sugar in
the blood. It can occur if:

you take too much Lyumjev or another insulin;
you delay or miss a meal or change your diet;
you do strenuous physical activity or exercise immediately before or after a meal;
you have an infection or other illness (especially diarrhea or vomiting);
there is a change in your insulin needs, for example if you lose weight, or if a pre-existing kidney or liver disorder worsens. See section "If you use more Lyumjev than you should".

Usually, the first symptoms of hypoglycemia come on quickly and include:

tiredness
fast heartbeat
nervousness or agitation
feeling unwell
headache
cold sweat.

If you are unable to recognise the warning signs of hypoglycemia, avoid situations, such as
driving a car, in which hypoglycemia could put you or others at risk.

High blood sugar(hyperglycemia) and diabetic ketoacidosis
Hyperglycemia (too much sugar in the blood) indicates that the glucose levels in your body are
too high. Hyperglycemia can be caused by:

not taking enough insulin;
using less insulin than you need for your body;
an imbalance between the amount of carbohydrates you eat and the insulin you take; or
fever, infection or severe emotional stress.

The first symptoms of hyperglycemia are:

feeling very thirsty
headache
feeling sleepy
needing to urinate more often.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. Further symptoms include:

nausea and/or vomiting
abdominal pain
rapid breathing
heavy breathing
moderate or large amounts of ketones in the urine. Ketones are produced when the body burns fat for energy instead of glucose.

If you have any of these symptoms and high blood sugar seek immediate medical attention.
See section “If you forget to take Lyumjev”.

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.Test your
urine and blood, follow the precautions you already know when you are ill and tell your doctor.

5. How to store Lyumjev 200 units/mL KwikPen

Keep this medicine 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.
Keep in the original package to protect from light.

Before first use
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.

After first use
Do not store above 30 °C.
Do not freeze.
Do not refrigerate.
Lyumjev 200 units/mL KwikPen must not be stored with the needle attached. Keep the cap
on the pen to protect from light.
Dispose of after 28 days even if some of the solution remains.
Do not dispose of any medicine in 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 Lyumjev 200 units/mL KwikPen injectable solution contains

The active ingredient is insulin lispro. Each mL of solution contains 200 units of insulin lispro. One Lyumjev 200 units/mL KwikPen contains 600 units of insulin lispro in 3 mL of solution.
The excipients are metacresol, glycerol, magnesium chloride hexahydrate, disodium citrate dihydrate, sodium treprostinil, zinc oxide, water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH (see at the end of paragraph 2 under “Lyumjev 200 units/mL KwikPen contains sodium”).

Description of the appearance of Lyumjev 200 units/mL KwikPen and package contents
Lyumjev 200 units/mL KwikPen, injectable solution is an aqueous, clear, colorless solution
contained in a prefilled pen.
Each prefilled pen contains 600 units (3 milliliters).
Packs of 2, 5 or multi-pack of 10 (2 x5) prefilled pens.
Not all pack sizes may be marketed.
Lyumjev 200 units/mL KwikPen is taupe colored. The dose selector button is taupe with raised markings on the side. The label is white with a blue stripe and a checkerboard pattern. The insulin concentration is highlighted in a box with a yellow background on the packaging and label.
The yellow warning label on the cartridge container reminds you to "Only use in this pen, otherwise a serious overdose may occur".
Each Lyumjev 200 units/mL KwikPen delivers from 1 to 60 units in 1-unit increments in a single injection.

Marketing authorization holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France
Rue du Colonel Lilly
67640 Fegersheim
France
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
Dista 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
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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Instructions for use

Lyumjev 200 units/mL KwikPen injectable solution in prefilled pen

insulin lispro

Prefilled syringe with retracted plunger and transparent protective needle screwed on

READ THESE INSTRUCTIONS BEFORE USE

Yellow triangular warning sign with a black exclamation mark in the center on a yellow background and black border

Read the instructions for use before using Lyumjev and each time you need to use another Lyumjev KwikPen. There may be new information. This information does not replace consultation with healthcare professionals regarding your medical condition or treatment.

Do not share your Lyumjev KwikPen with others, even if the needle has been changed. Do not reuse needles or share them with others. This could cause a serious infection in others or give you a serious infection.
Lyumjev 200 units/mL KwikPen (“Pen”) is a disposable prefilled pen containing 3 mL (600 units, 200 units/mL) of insulin lispro injectable solution.

Healthcare professionals will tell you how many units to administer as a dose and how to inject the prescribed dose of insulin.
You can administer more than 1 dose from the Pen.
Each rotation of the dose selector button selects 1 unit of insulin. You can inject from 1 to 60 units in a single injection.
If your dose is higher than 60 units, you will need to administer more than 1 injection. Always check the number in the dosage window to make sure you have selected the correct dose.
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. Lyumjev KwikPen is available in two concentrations, 100 units/mL and 200 units/mL. Inject Lyumjev 200 units/mL only using the Pen. Do not transfer insulin from the Pen to any other insulin delivery device. Syringes and insulin infusion micro-infusers will not deliver 200 units/mL of insulin correctly. A serious overdose may occur, causing a very low blood sugar level, which can endanger your life.
This pen should not be used by people who are blind or have visual impairments without the assistance of a person trained to use the Pen.
Components of the Lyumjev KwikPen
Pen Cap Cartridge Holder Label Dose Indicator

Prefilled syringe with retracted plunger, cross-section of the internal mechanism and needle protected by a safety cap

Cap Clip Cartridge Seal Pen Body Dosage Window Button
selector of the
dose
rubber Pen of
dosage

Components of the needle for the Pen
(needles are not included)
Dose selector
button

Brown cylindrical cap with two lateral slots to facilitate removal from the medicinal vial

Components of a medical device: cylinder with tip, plunger, spring-loaded needle and protective cap

Outer Cap Inner Needle Paper Protection
of the needle of the needle

How to recognize Lyumjev KwikPen

Pen Color: Taupe
Dose selector button: Taupe, with raised markings on the side
Label: White with a blue stripe and a checkered pattern. Warning in yellow on the cartridge container

Materials needed to administer

Lyumjev KwikPen
Needle compatible with the KwikPen (BD [Becton, Dickinson and Company] pen needles are recommended)
Cotton swab or gauze

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.
Donot use 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 newneedlefor each injection to help prevent infections and needle blockages.

Point 1: Remove the Pen cap. Do not remove the Pen label. Clean the rubber closure with a swab.	o c a USE ONLY WITH THIS PEN, OTHERWISE A SERIOUS OVERDOSE MAY OCCUR
Point 2: Check the appearance of the liquid in the Pen. Lyumjev should appear clear and colorless. Do not use it if it appears cloudy, colored, or if it contains particles or clumps.	l F a r
Point 3: Select a new needle. Remove the paper protection from the outer cap of the needle. a	d e
n Point 4: Insert the needle covered by the cap straight onto the end of the Pen and rotate the needle until it is firmly attached. i
a Point 5: t Remove the outer cap of the needle. Do not throw it away. Remove the inner cap of the needle and throw it away.	Hold Discard

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 is working correctly.
If you do notload before each injection, you may inject too much or too little insulin.

Point 6:

To load the Pen, select 2 units by rotating the dose selector button.

r m a

Vial with graduated scale from 1 to 2 and red arrow indicating the point of injection side

Hand holding an injection device with yellow cartridge and visible needle preparation for

Point 7:

Hold the Pen with the needle pointing upwards. Tap the cartridge gently to collect the air on the surface.

l F a

Injectable pen held in hand with red arrow indicating the direction towards

Point 8:

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. i

If you do not see insulin, repeat the loading operations from point 6 to 8, but no more than 8 times.
If you still do not see insulin, change the needle and repeat the loading operations from point 6 to 8. Small air bubbles are normal and do not interfere with the dosage.

d e

Scheme of an insulin pen with numeric indicator and side dosage window

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 higher than 60 units you will need to administer more than 1 injection.

If you need help dividing the dose correctly, ask healthcare professionals.
You must use a new needle for each new injection and repeat the loading operation.

Point 9:

Hand inserting a cartridge numbered 8 into a pen device with a red arrow indicating the direction

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.

Scheme of a medical device with two rectangular components connected by a diagonal line and numeric indication 12

Do notselect the dose by counting the number of clicks. You may select the wrong dose. This could cause you to take too much or too little insulin. Example: 12 units shown in the dosage window
The dose can be corrected by rotating the dose selector button in any direction until the correct dose is aligned with the dose indicator.
The evennumbers are printed on the dial. The example on the right shows 12 units.

The oddnumbers after the number 1 are displayed as solid lines between the numbers. The example on the right shows 25 units.

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 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. Do not transfer it to a syringe. A serious overdose may occur.

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 making the injection.

Point 10: Choose the injection site. Lyumjev is injected under the skin (subcutaneous injection) of the abdominal area, buttocks, thighs, or upper arms. Clean the skin with a swab and wait until the skin is dry before injecting the dose.	e l F a r m
Point 11: Insert the needle into the skin. Press the dose selector button all the way down. n Continue to hold the dose selector button down for 5 sec and count slowly to 5 before removing the needle. i l 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.	a d

Point 12:

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, this means you have administered the entire amount selected.
If you do not see “0” in the dosage window, this means you have not administered the entire dose. Do not reselect the dose. Insert the needle into the skin and finish your injection.
If you think you have not yet received the entire amount you selected for the injection, do not restart or repeat the injection. Check your blood glucose level as indicated by healthcare professionals. a
If you normally need 2 injections to administer the entire dose, make sure you perform the second injection. The plunger moves only slightly with each injection and you may not notice the movement. If you see blood after you have removed the needle from the skin, press lightly on the injection site with gauze or a swab. Do not rub the affected area.

d e l F a r m a c o
Scheme of an insulin pen with dosage indication 10 units and upper part with rectangular buttons

After the injection

a Point 13: Carefully replace the outer cap on the needle. z n
e Point 14: g Unscrew the needle covered by the cap and dispose of it as described below (see the paragraph A “Disposal of the Pen and Needles”). Do not store the Pen with the needle inserted to prevent leakage, needle blockage, and air entering the Pen.

Point 15:

Replace the cap on the Pen holding it with the cap clip aligned with the dose indicator and press straight down onto the Pen.

c o

Injectable pen with protective needle slider indicated by an orange arrow towards the insertion point

Disposal of the Pen and Needles

Place used needles in a closable, puncture-resistant container or a hard plastic container with a secure lid. Do notdispose of needles directly into household waste containers.
Do notrecycle the container once it is filled with needles.
Ask healthcare professionals about available options for proper disposal of the Pen and the container.
Instructions regarding needle handling should not replace local, institutional, or healthcare professional regulations.

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. For further information or if you have problems with Lyumjev 200 units/mL KwikPen, contact healthcare professionals for assistance or contact your local Eli Lilly branch.

Document revision date:

Kraj rejestracji
Włochy
Postać farmaceutyczna
Injectable solution, 100 U/ML
Kod ATC
A10AB04
Substancja czynna
insulin lispro
Wymaga recepty
Tak
Producent
ELI LILLY NEDERLAND B.V.
Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
Zamienniki LYUMJEV
UMALOG
Postać farmaceutyczna: Injectable solution, 100 U/ML
Substancja czynna: insulin lispro
Producent: ELI LILLY NEDERLAND B.V.
Wymaga recepty
INSULINA LISPRO SANOFI
Postać farmaceutyczna: Injectable solution, 100 U/ML
Substancja czynna: insulin lispro
Producent: SANOFI WINTHROP INDUSTRIE
Wymaga recepty
AKTRAPID
Postać farmaceutyczna: Injectable solution, 40 IU/ML
Substancja czynna: insulin (human)
Producent: NOVO NORDISK A/S
Wymaga recepty

Odpowiedniki LYUMJEV w innych krajach

Leki z tą samą substancją czynną dostępne w innych krajach.

Odpowiednik LYUMJEV w Hiszpania

LYUMJEV 200 jednostek/ml KWIKPEN ROZTÓR DO WSTRZYKIWAŃ W APLIKATORZE PRZEDNAWIELONYM

Postać farmaceutyczna: ROZTWÓR DO WSTRZYKIWAŃ, 200 IU/ml

Substancja czynna: insulin lispro

Producent: Eli Lilly Nederland B.V.

Wymaga recepty

LYUMJEV 100 jednostek/ml TEMPO PEN WSTRZYKIWACZ WYPEŁNIONY, ROZTÓR DO WSTRZYKIWAŃ

Postać farmaceutyczna: ROZTWÓR DO WSTRZYKIWAŃ, 100 IU/ml

Substancja czynna: insulin lispro

Producent: Eli Lilly Nederland B.V.

Wymaga recepty

LYUMJEV 100 jednostek/ml ROZTÓR DO WSTRZYKIWAŃ W AMPULCE

Postać farmaceutyczna: ROZTWÓR DO WSTRZYKIWAŃ, 100 IU/ml

Substancja czynna: insulin lispro

Producent: Eli Lilly Nederland B.V.

Wymaga recepty

LYUMJEV 100 jednostek/ml JUNIOR KWIKPEN ROZTÓR DO WSTRZYKIWAŃ W APLIKATORZE PRZEDNAWIERCONYM

Postać farmaceutyczna: ROZTWÓR DO WSTRZYKIWAŃ, 100 IU/ml

Substancja czynna: insulin lispro

Producent: Eli Lilly Nederland B.V.

Wymaga recepty

HUMALOG 100 U/ml ROZTÓR DO WSTRZYKIWAŃ W AMPULKACH

Postać farmaceutyczna: ROZTWÓR DO WSTRZYKIWAŃ, 100 IU/ml

Substancja czynna: insulin lispro

Producent: Eli Lilly Nederland B.V.

Wymaga recepty

HUMALOG KWIKPEN 200 jm/ml Roztwór do wstrzykiwań w gotowym do użycia wstrzykiwaczu

Postać farmaceutyczna: ROZTWÓR DO WSTRZYKIWAŃ, 200 jednostek/ml

Substancja czynna: insulin lispro

Producent: Eli Lilly Nederland B.V.

Wymaga recepty

Odpowiednik LYUMJEV w Ukraina

HUMALOG

Postać farmaceutyczna: solution, 100 IU/ml 3 ml

Substancja czynna: insulin lispro

Producent: Lilli Frans (virobnictvo za povnim ciklom)

Wymaga recepty

Lekarze online w sprawie LYUMJEV

Omów stosowanie LYUMJEV, bezpieczeństwo i ocenę zasadności recepty zgodnie z obowiązującymi przepisami.

5.0(11)

Anna Biriukova

Gastroenterologia6 lat doświadczenia

Kardiologia – diagnostyka i leczenie:

Nadciśnienie tętnicze, wahania ciśnienia i profilaktyka powikłań sercowo-naczyniowych.
Bóle w klatce piersiowej, duszność, arytmie (tachykardia, bradykardia, kołatania serca).
Obrzęki kończyn, przewlekłe zmęczenie, spadek tolerancji wysiłku.
Interpretacja EKG, ocena profilu lipidowego, analiza ryzyka zawału i udaru.
Opieka kardiologiczna po COVID-19.

Endokrynologia – cukrzyca, tarczyca, metabolizm:

Rozpoznawanie i leczenie cukrzycy typu 1 i 2, stanu przedcukrzycowego.
Indywidualnie dobrane plany terapii z wykorzystaniem leków doustnych i insulinoterapii.
Leczenie GLP-1 – nowoczesna farmakoterapia wspierająca redukcję masy ciała i kontrolę cukrzycy, w tym dobór preparatów, monitorowanie efektów i bezpieczeństwa.
Zaburzenia tarczycy – niedoczynność, nadczynność, choroby autoimmunologiczne (Hashimoto, Graves-Basedow).
Metabolic syndrome – otyłość, zaburzenia lipidowe, insulinooporność.

Gastroenterologia – układ pokarmowy:

Bóle brzucha, nudności, zgaga i refluks żołądkowo-przełykowy (GERD).
Choroby żołądka i jelit: zapalenie błony śluzowej żołądka, zespół jelita drażliwego (IBS), niestrawność.
Kontrola przewlekłych schorzeń przewodu pokarmowego i interpretacja wyników badań (gastroskopia, USG, testy laboratoryjne).

Opieka internistyczna i profilaktyka:

Infekcje dróg oddechowych – kaszel, przeziębienie, zapalenie oskrzeli.
Analiza wyników badań laboratoryjnych, dostosowanie leczenia i leków.
Szczepienia dorosłych – dobór schematu i ocena przeciwwskazań.
Profilaktyka nowotworowa – planowanie badań przesiewowych i ocena ryzyka.
Holistyczne podejście do pacjenta – leczenie objawów, zapobieganie powikłaniom i poprawa jakości życia.

Lek. Biriukova łączy wiedzę internistyczną z podejściem specjalistycznym, oferując pacjentom jasne wyjaśnienia, przejrzyste plany leczenia i spersonalizowaną opiekę.

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5.0(36)

Andrei Popov

Medycyna ogólnaMedycyna bólu7 lat doświadczenia

Dr Andrei Popov jest lekarzem rodzinnym ze specjalistycznym przygotowaniem w zakresie leczenia bólu przewlekłego. Prowadzi konsultacje wideo dla dorosłych w Hiszpanii i w całej Europie: zarówno jeśli od miesięcy zmagasz się z bólem, którego nikt nie potrafił dobrze wyjaśnić, jak i wtedy, gdy potrzebujesz rozwiązać problem zdrowotny bez czekania tygodniami na wizytę.

Jego podejście jest jasne: wysłuchać, uporządkować Twój przypadek i przedstawić praktyczny plan działania oparty na medycynie opartej na dowodach oraz dostosowany do Twojej historii medycznej i potrzeb.

Ból: w czym może pomóc

Ból przewlekły (ponad 3 miesiące)
Migrena i nawracające lub bardzo silne bóle głowy
Ból szyi, odcinka lędźwiowego, pleców i stawów
Ból pourazowy po urazach lub operacjach
Ból pochodzenia neurologicznego: neuralgia, ból neuropatyczny, fibromialgia

Medycyna ogólna

Częste infekcje dróg oddechowych (przeziębienie, grypa, uporczywy kaszel)
Nadciśnienie, cukrzyca i zaburzenia metaboliczne
Omówienie wyników badań laboratoryjnych oraz raportów MRI/CT (wyjaśnione prostym językiem)
Medycyna profilaktyczna i monitorowanie zdrowia
Druga opinia oraz dostosowanie leczenia (jeśli jest to klinicznie uzasadnione)

Jak wygląda konsultacja
Każda sesja trwa do 30 minut. Omawiane są objawy, historia choroby, przyjmowane leki oraz dostarczone badania. Na zakończenie otrzymujesz jasny plan leczenia, kolejne kroki oraz wskazówki, kiedy warto zaplanować dalszą kontrolę. Jeśli zostaną wykryte sygnały alarmowe, lekarz jasno poinformuje, czy konieczna jest wizyta osobista lub pilna pomoc medyczna.

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5.0(1)

Abdullah Alhasan

Medycyna ogólnaKardiologia11 lat doświadczenia

Lek Abdullah Alhasan to internista z doświadczeniem klinicznym w Wielkiej Brytanii i we Włoszech. Oferuje zdalne konsultacje dla dorosłych pacjentów w zakresie objawów ostrych i przewlekłych, z podejściem opartym na aktualnych standardach medycznych.

Główne obszary konsultacji:

Infekcje, gorączka, kaszel, objawy grypopodobne
Zmęczenie, osłabienie, bóle ciała, problemy trawienne
Nadciśnienie tętnicze i profilaktyka chorób układu krążenia
Interpretacja wyników badań (krew, EKG, Holter)
Choroby serca: arytmie, duszność, ból w klatce piersiowej
Dostosowanie terapii i wsparcie w organizacji dalszej diagnostyki

Lek Alhasan prowadzi konsultacje z uwagą na potrzeby pacjenta, oferując rzetelną ocenę stanu zdrowia, jasne wyjaśnienia i spersonalizowane zalecenia – wszystko w formacie wygodnych wizyt online.

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5.0(2)

Dmytro Horobets

Medycyna rodzinnaEndokrynologia7 lat doświadczenia

Lek. Dmytro Horobets jest licencjonowanym lekarzem rodzinnym w Polsce, specjalizującym się w endokrynologii, diabetologii, leczeniu otyłości, gastroenterologii, pediatrii, chirurgii ogólnej oraz terapii bólu. Prowadzi konsultacje online dla dorosłych i dzieci, oferując spersonalizowane wsparcie medyczne w przypadku szerokiego zakresu chorób ostrych i przewlekłych.

Obszary specjalizacji obejmują:

Endokrynologia: cukrzyca typu 1 i 2, stan przedcukrzycowy, choroby tarczycy, zespół metaboliczny, zaburzenia hormonalne
Leczenie otyłości: indywidualne plany redukcji masy ciała, porady żywieniowe, ocena ryzyka zdrowotnego związanego z otyłością
Gastroenterologia: refluks żołądkowo-przełykowy (GERD), zapalenie żołądka, zespół jelita drażliwego (IBS), choroby wątroby i dróg żółciowych
Opieka pediatryczna: infekcje, objawy ze strony układu oddechowego, dolegliwości trawienne, monitorowanie rozwoju i wzrastania
Wsparcie chirurgiczne: konsultacje przed- i pooperacyjne, opieka nad ranami, rehabilitacja
Terapia bólu: ból przewlekły i ostry, bóle kręgosłupa, stawów, zespoły bólowe pourazowe
Zdrowie sercowo-naczyniowe: nadciśnienie, kontrola cholesterolu, ocena ryzyka chorób serca
Medycyna profilaktyczna: badania kontrolne, profilaktyczne, długoterminowe prowadzenie chorób przewlekłych

Lek. Horobets łączy praktykę opartą na dowodach z podejściem skoncentrowanym na pacjencie. Dokładnie analizuje historię choroby i objawy, zapewniając jasne wyjaśnienia i strukturalne plany leczenia dostosowane do indywidualnych potrzeb.

Niezależnie od tego, czy potrzebujesz wsparcia w kontroli cukrzycy, radzeniu sobie z otyłością, interpretacji wyników badań, czy opieki rodzinnej – dr Horobets zapewnia profesjonalną pomoc online, dostosowaną do Twoich celów zdrowotnych.

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5.0(19)

Nuno Tavares Lopes

Medycyna rodzinnaMedycyna ogólna18 lat doświadczenia

Lek. Nuno Tavares Lopes jest licencjonowanym lekarzem w Portugalii z 17-letnim doświadczeniem w medycynie ratunkowej, medycynie rodzinnej, praktyce ogólnej i zdrowiu publicznym. Pełni funkcję Dyrektora ds. Medycznych i Zdrowia Publicznego w międzynarodowej sieci medycznej oraz jest zewnętrznym konsultantem WHO i ECDC.

Zakres konsultacji obejmuje:

Opiekę doraźną: infekcje, gorączka, ból w klatce piersiowej lub brzuchu, drobne urazy, nagłe przypadki pediatryczne
Medycynę rodzinną: nadciśnienie, cukrzyca, wysoki cholesterol, opieka nad chorobami przewlekłymi
Medycynę podróży: porady przedwyjazdowe, szczepienia, zaświadczenia fit-to-fly, choroby związane z podróżą
Zdrowie seksualne i reprodukcyjne: PrEP, profilaktyka STD, konsultacje, leczenie
Kontrolę masy ciała i zdrowy styl życia: indywidualne programy odchudzania, porady dotyczące stylu życia
Problemy dermatologiczne i laryngologiczne: trądzik, egzema, alergie, wysypki, ból gardła, zapalenie zatok
Leczenie bólu: ból ostry i przewlekły, opieka pooperacyjna
Zdrowie publiczne: profilaktyka, badania przesiewowe, monitorowanie długoterminowe
Zwolnienia lekarskie (Baixa médica) powiązane z Segurança Social w Portugalii
Zaświadczenia medyczne IMT potrzebne do wymiany prawa jazdy

Lek. Nuno Tavares Lopes zapewnia opiekę medyczną pacjentom stosującym leki z grupy GLP-1 (Mounjaro, Wegovy, Ozempic, Rybelsus) w ramach leczenia nadwagi lub otyłości. Oferuje indywidualny plan terapii, regularne wizyty kontrolne, dostosowanie dawek oraz zalecenia dotyczące łączenia leczenia z trwałymi zmianami stylu życia. Konsultacje odbywają się zgodnie z europejskimi standardami medycznymi.

Lek. Lopes zajmuje się również interpretacją badań diagnostycznych, opieką nad pacjentami złożonymi oraz zapewnia wsparcie wielojęzyczne. Niezależnie od tego, czy chodzi o nagłe problemy zdrowotne, czy długoterminową opiekę, pomaga pacjentom działać z pewnością i spokojem.

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5.0(1)

Duarte Meneses

Medycyna rodzinnaMedycyna ogólna5 lat doświadczenia

Lek. Duarte Meneses jest licencjonowanym lekarzem rodzinnym i specjalistą medycyny ogólnej z Portugalii, z dodatkową wiedzą w zakresie medycyny pracy. Prowadzi konsultacje online dla dorosłych, oferując wsparcie medyczne zarówno w nagłych przypadkach, jak i przy chorobach przewlekłych.

Najczęstsze objawy, takie jak gorączka, ból gardła, kaszel, zmęczenie czy problemy trawienne
Choroby przewlekłe, m.in. nadciśnienie, cukrzyca, podwyższony cholesterol, problemy z tarczycą
Kwestie zdrowia psychicznego: stres, problemy ze snem, lęk, wypalenie
Opieka profilaktyczna: badania kontrolne, porady dotyczące stylu życia, monitorowanie stanu zdrowia
Zdrowie związane z pracą: zwolnienia lekarskie, dokumentacja, wskazówki dotyczące powrotu do pracy

Lek. Meneses ukończył Uniwersytet Beira Interior i ma wieloletnie doświadczenie w pracy z pacjentami o różnym profilu zdrowotnym. Posługuje się językiem portugalskim, angielskim, hiszpańskim i francuskim.

Jego podejście jest przyjazne, zrozumiałe i skupione na udzielaniu praktycznych porad medycznych dopasowanych do indywidualnych potrzeb pacjenta.

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5.0(6)

Mar Tabeshadze

EndokrynologiaMedycyna ogólna11 lat doświadczenia

Lek. Mar Tabeshadze jest licencjonowanym endokrynologiem i lekarzem rodzinnym w Hiszpanii. Prowadzi konsultacje online dla dorosłych, oferując kompleksowe wsparcie medyczne w zakresie chorób endokrynologicznych i zaburzeń hormonalnych.

Konsultacje diagnostyczne przy podejrzeniu chorób endokrynologicznych
Leczenie i kontrola chorób tarczycy, także u kobiet w ciąży
Wczesne rozpoznanie i terapia cukrzycy typu 1 i 2 z indywidualnym planem leczenia
Leczenie otyłości: identyfikacja przyczyn przyrostu masy ciała, połączenie leczenia farmakologicznego i niefarmakologicznego, długoterminowe wsparcie
Diagnostyka i leczenie zaburzeń hormonalnych wpływających na skórę, włosy i paznokcie
Stała opieka dla pacjentów z osteoporozą, chorobami przysadki i nadnerczy

Lek. Tabeshadze stosuje podejście skoncentrowane na pacjencie i oparte na medycynie opartej na dowodach. Jej celem jest przywracanie równowagi hormonalnej, skuteczne leczenie chorób przewlekłych oraz poprawa jakości życia dzięki spersonalizowanej opiece.

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5.0(11)

Sergio Correa

Medycyna ogólnaGeriatria8 lat doświadczenia

Dr Sergio Correa to licencjonowany lekarz ogólny i specjalista medycyny ratunkowej w Hiszpanii, konsultujący online w języku hiszpańskim i angielskim. Udziela wsparcia osobom dorosłym w przypadku nagłych objawów, chorób przewlekłych, zaburzeń hormonalnych oraz problemów estetycznych i dermatologicznych.

Zakres konsultacji online:

Medycyna ogólna: gorączka, kaszel, infekcje dróg oddechowych i pokarmowych, bóle brzucha, zmęczenie, bóle mięśni i stawów.
Choroby przewlekłe: nadciśnienie, cukrzyca, podwyższony cholesterol, zaburzenia tarczycy, refluks i inne dolegliwości przewodu pokarmowego.
Trychologia: diagnostyka i leczenie wypadania włosów, łupieżu, chorób skóry głowy.
Medycyna estetyczna: doradztwo medyczne w zakresie zabiegów estetycznych, ocena stanu skóry i ogólnego samopoczucia.
Profilaktyka: interpretacja wyników badań, zalecenia zdrowotne, kontrole okresowe.

Dr Correa łączy doświadczenie kliniczne z empatycznym podejściem do pacjenta, zapewniając wygodny i profesjonalny dostęp do opieki medycznej online.

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5.0(1)

Khrystyna Habrykevych

Gastroenterologia7 lat doświadczenia

Khrystyna Habrykevych jest lekarzem gastroenterologiem i prowadzi konsultacje online dla osób dorosłych z dolegliwościami ze strony układu pokarmowego. Pomaga zrozumieć przyczyny objawów, interpretuje wyniki badań i proponuje dalsze kroki diagnostyczne lub terapeutyczne – w zależności od sytuacji pacjenta.

Najczęstsze powody zgłoszenia się na konsultację:

bóle brzucha, skurcze jelit, dyskomfort, bolesne parcie na stolec
zgaga, refluks, odbijanie, gorzki posmak w ustach
wzdęcia, nadmierne gazy, nudności, wymioty
biegunki, zaparcia, trudności z wypróżnianiem
niepokój o zdrowie układu trawiennego lub przewlekłe objawy
problemy z wagą lub apetytem
nieprawidłowości w wynikach badań, potrzeba ich omówienia
profilaktyczne badania przesiewowe w kierunku nowotworów przewodu pokarmowego
ogólna ocena zdrowia układu pokarmowego (check-up)

Konsultacje odbywają się online, w komfortowych warunkach i bez konieczności wychodzenia z domu. Lekarka opiera się na aktualnych wytycznych medycznych i dostosowuje podejście do indywidualnych potrzeb pacjenta.

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5.0(4)

Iryna Reznychenko

GinekologiaEndokrynologiaMedycyna laktacyjna26 lat doświadczenia

Lek Iryna Reznychenko to ginekolożka, ginekolożka dziecięca oraz certyfikowana doradczyni laktacyjna. Udziela konsultacji online kobietom na różnych etapach życia – od okresu dojrzewania po menopauzę. Łączy opiekę ginekologiczną z fachowym wsparciem w zakresie karmienia piersią, dbając zarówno o zdrowie fizyczne, jak i samopoczucie emocjonalne pacjentek.

Zakres konsultacji:

analiza wyników badań i dobór indywidualnego leczenia
zaburzenia cyklu miesiączkowego, PCOS, endometrioza
krwawienia z macicy, przerost endometrium, dysplazja szyjki macicy
opieka w okresie menopauzy i profilaktyka onkologiczna
problemy z laktacją: ból, pęknięcia brodawek, zastoje, niska produkcja mleka
wsparcie w połogu i w okresie karmienia piersią

Iryna Reznychenko oferuje profesjonalne, empatyczne i dostosowane do sytuacji podejście. Konsultacje online pozwalają zareagować na czas i uniknąć powikłań – w atmosferze zaufania i pełnego zrozumienia.

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Uzyskaj receptę na LYUMJEV online

Wypełnij 2-minutowy formularz

Opisz swoje objawy, historię choroby i lek, o który prosisz.

Wybierz lekarza lub pozwól nam przydzielić

Wybierz specjalistę lub dopasujemy Cię do najbliższego dostępnego lekarza.

Lekarz analizuje Twój przypadek

Zazwyczaj w ciągu 30 minut. Może zadawać dodatkowe pytania przez czat.

Odbierz w dowolnej aptece

Recepta elektroniczna wysłana na Twój e-mail — ważna w całej Polsce.

Często zadawane pytania

Czy LYUMJEV wymaga recepty?

LYUMJEV wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.

Jaka jest substancja czynna w LYUMJEV?

Substancją czynną w LYUMJEV jest insulin lispro. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.

Kto produkuje LYUMJEV?

LYUMJEV jest produkowany przez ELI LILLY NEDERLAND B.V.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.

Którzy lekarze mogą ocenić stosowanie LYUMJEV online?

Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie LYUMJEV jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.

Jak kupić LYUMJEV w Polsce?

Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.

Możesz kupić LYUMJEV w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.

Aby uzyskać receptę, możesz skorzystać z Oladoctor:

Jakie są alternatywy dla LYUMJEV?

Inne leki zawierające tę samą substancję czynną (insulin lispro) to m.in. UMALOG, INSULINA LISPRO SANOFI, AKTRAPID. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.

LYUMJEV 100 U/ML Roztwór do wstrzykiwań

Ocena recepty online

Porozmawiaj z lekarzem o tym leku

Anna Biriukova

Jak stosować LYUMJEV

Lyumjev 100 units/mL injectable solution in a vial

1. What is Lyumjev and what is it used for

2. What you need to know before using Lyumjev

3. How to use Lyumjev

4. Possible side effects

5. How to store Lyumjev

6. Contents of the pack and other information

Lyumjev 100 units/mL injectable solution in cartridge

1. What is Lyumjev and what it is used for

2. What you need to know before using Lyumjev

3. How to use Lyumjev

4. Possible side effects

5. How to store Lyumjev

6. Contents of the pack and other information

Nie jesteś pewien, czy ten lek jest odpowiedni dla ciebie?

Lyumjev 100 units/mL KwikPen prefilled pen injectable solution

1. What is Lyumjev KwikPen and what is it used for

2. What you need to know before using Lyumjev KwikPen

3. How to use Lyumjev KwikPen

4. Possible side effects

5. How to store Lyumjev KwikPen

6. Contents of the pack and other information

Lyumjev 100 units/mL KwikPen injectable solution in prefilled pen

Zacząłeś przyjmować lek i masz pytania?

Lyumjev 100 units/mL Junior KwikPen injectable solution in prefilled pen

1. What is Lyumjev Junior KwikPen and what it is used for

2. What you need to know before using Lyumjev Junior KwikPen

3. How to use Lyumjev Junior KwikPen

4. Possible side effects

5. How to store Lyumjev Junior KwikPen

6. Contents of the pack and other information

Lyumjev 100 units/mL Junior KwikPen injectable solution in prefilled pen

Lyumjev 100 units/mL Tempo Pen prefilled pen solution for injection

1. What is Lyumjev Tempo Pen and what is it used for

2. What you need to know before using Lyumjev Tempo Pen

3. How to use Lyumjev Tempo Pen

4. Possible side effects

5. How to store Lyumjev Tempo Pen

6. Contents of the pack and other information

Lyumjev 100 units/mL Tempo Pen injectable solution in a prefilled pen

Lyumjev 200 units/mL KwikPen pre-filled pen injectable solution

1. What is Lyumjev 200 units/mL KwikPen and what is it used for

2. What you need to know before using Lyumjev 200 units/mL KwikPen

3. How to use Lyumjev 200 units/mL KwikPen

4. Possible side effects

5. How to store Lyumjev 200 units/mL KwikPen

6. Package contents and other information

Lyumjev 200 units/mL KwikPen injectable solution in prefilled pen

Odpowiedniki LYUMJEV w innych krajach

Odpowiednik LYUMJEV w Hiszpania

Odpowiednik LYUMJEV w Ukraina

Lekarze online w sprawie LYUMJEV

Anna Biriukova

Andrei Popov

Abdullah Alhasan

Dmytro Horobets

Nuno Tavares Lopes

Duarte Meneses

Mar Tabeshadze

Sergio Correa

Khrystyna Habrykevych

Iryna Reznychenko

Uzyskaj receptę na LYUMJEV online

Często zadawane pytania

Bądź na bieżąco z Oladoctor