NIVESTIM 12 MU Инъекционный раствор

Содержание инструкции

1. Nivestim 12 MU/0.2 ml injectable solution or infusion, 30 MU/0.5 ml injectable solution or infusion, 48 MU/0.5 ml injectable solution or infusion
   1. What you need to know before using Nivestim
   2. How to use Nivestim
   3. Possible side effects
   4. How to store Nivestim
   5. Other information

Nivestim 12 MU/0.2 ml injectable solution or infusion, 30 MU/0.5 ml injectable solution or infusion, 48 MU/0.5 ml injectable solution or infusion

filgrastim

Read this leaflet carefully before you use this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

• 1. What Nivestim is and what it is used for

Nivestim is a white blood cell growth factor (granulocyte colony-stimulating factor) and belongs to a group of medicines called cytokines. Growth factors are
proteins produced naturally in the body, but they can be produced with the aid of biotechnology,
to be used as medicines. Nivestim stimulates the bone marrow to produce a greater number of
white blood cells.
A reduction in the number of white blood cells (neutropenia) can occur for various
reasons, reducing the body's ability to defend itself against infections. Nivestim stimulates the bone marrow
to rapidly produce new white blood cells.
Nivestim can be used:

• to increase the number of white blood cells after chemotherapy treatment, thus helping to prevent infections;
• to increase the number of white blood cells after a bone marrow transplant, thus helping to prevent infections;
• before high-dose chemotherapy to induce the bone marrow to produce more stem cells that can be collected and re-infused after treatment. These cells can be taken from you or from a donor. The stem cells will then return to the bone marrow and produce blood cells;
• to increase the number of white blood cells if you have severe chronic neutropenia, thus helping to prevent infections;
• in patients with advanced HIV infection, to help reduce the risk of infections.

2. What you need to know before using Nivestim

Do not use Nivestim

• if you are allergic to filgrastim or any of the excipients of this medicine (listed in

section 6). Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Nivestim.
Consult your doctor before starting treatment if you suffer from:

• sickle cell anemia, as Nivestim may cause sickle cell crises;
• osteoporosis (bone disease).

Immediately inform your doctor during treatment with Nivestim if:

• you have sudden signs of allergy, such as skin rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath or wheezing or difficulty breathing, as these are signs of a severe allergic reaction (hypersensitivity).
• you experience swelling of the face or ankles, blood in the urine or brown-colored urine, or notice that you are urinating less than usual (glomerulonephritis).
• you feel pain in the upper left area of the abdomen (abdominal pain), pain under the left side of the rib cage or at the end of the left shoulder (these may be symptoms of an enlarged spleen (splenomegaly), or possible rupture of the spleen).
• you notice unusual bleeding or the appearance of bruises (these may be symptoms of a decrease in the number of platelets in the blood (thrombocytopenia), with a reduced ability of the blood to clot).

Inflammation of the aorta (the large blood vessel that carries blood
from the heart to the rest of the body) has been rarely reported in cancer patients and healthy individuals. Symptoms may include
fever, abdominal pain, malaise, back pain, and increased inflammatory markers.
Inform your doctor if you experience such symptoms.

Loss of response to filgrastim
If you have a decrease in response or failure to maintain response to treatment
with filgrastim, your doctor will investigate the reasons, including the possibility that you have developed
antibodies that neutralize the activity of filgrastim.
Your doctor may decide to monitor you closely, see section 4 of the package leaflet.
If you are a patient with severe chronic neutropenia, you may be at risk of developing a blood cancer
(leukemia, myelodysplastic syndrome [MDS]). You should talk to your doctor about the risks of
developing blood cancers and what tests should be performed. If you develop or are at risk of
developing blood cancers, you should not use Nivestim unless prescribed by your doctor.
If you are a stem cell donor, you must be between 16 and 60 years of age.

Pay particular attention to other medicines that stimulate white blood cells
Nivestim is part of a group of medicines that stimulate the production of white blood cells.
The healthcare professional must always record the exact medicine you are using.

Other medicines and Nivestim
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
Nivestim has not been studied in pregnant women or breastfeeding women.
Nivestim is not recommended during pregnancy.
It is important that you inform your doctor if:

• you are pregnant or breastfeeding;
• you suspect you are pregnant or
• you are planning a pregnancy.

If you become pregnant during treatment with Nivestim, inform your doctor.
Unless otherwise indicated by your doctor, you should stop breastfeeding if you use Nivestim.

Driving and using machines
Nivestim may slightly impair your ability to drive vehicles and use machines. This
medicine can cause dizziness. It is recommended to wait and observe how you feel after
taking Nivestim before driving or using machines.

Nivestim contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose of 0.6 mg/ml or 0.96 mg/ml,
i.e. essentially “sodium-free”.

Nivestim contains sorbitol
This medicine contains 50 mg of sorbitol per ml.
Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with hereditary fructose intolerance (HFI), a rare genetic disease, you (or your child) should not take this
medicine. Patients with hereditary fructose intolerance (HFI) are unable to break down
fructose, the accumulation of which can cause serious adverse effects.
Before taking this medicine, inform your doctor if you (or your child) suffer from hereditary fructose intolerance (HFI) or if the child feels unwell, vomits or has unpleasant reactions such as
bloating and stomach cramps or diarrhea when consuming sweet foods or beverages.

3. How to use Nivestim

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor, nurse or pharmacist.

How is Nivestim administered and how much should I take?
Nivestim is generally administered by daily injection into the tissue just below
the skin (known as a subcutaneous injection). It can also be administered as a daily slow-release injection
into the vein (known as intravenous infusion). The usual dose varies
depending on your condition and your weight. Your doctor will tell you how much Nivestim you should take.
Patients receiving bone marrow transplant after chemotherapy:
Normally you will receive the first dose of Nivestim at least 24 hours after chemotherapy and at least 24
hours after receiving the bone marrow transplant.
You or the people who care for you may be taught how to administer subcutaneous injections so that you can continue treatment at home. However, do not attempt to give yourself
an injection unless you have first received appropriate instructions from your doctor.

How long will I have to take Nivestim?
You will have to take Nivestim until the number of white blood cells has returned to normal. Blood tests will be
performed to monitor the number of white blood cells in your blood. Your doctor
will tell you how long you will have to take Nivestim.

Use in children
Nivestim is used for the treatment of children undergoing chemotherapy or who suffer from a severe
reduction in the number of white blood cells in the blood (neutropenia). The dosage in children treated with
chemotherapy is the same as used in adults.

If you use more Nivestim than you should
Do not increase the dose that your doctor has prescribed. If you think you have injected more than
you should, contact your doctor as soon as possible.

If you forget to use Nivestim
If you have forgotten an injection, or the amount injected is too small, contact your
doctor as soon as possible. Do not take a double dose to make up for a missed dose.
If you have further questions about the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediatelyduring treatment:

• if you experience an allergic reaction including weakness, decreased blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnea).
• if you experience cough, fever and difficulty breathing (dyspnea), as these may be symptoms of acute respiratory distress syndrome (ARDS).
• if you experience kidney damage (glomerulonephritis). Kidney damage has been observed in patients receiving filgrastim. Contact your doctor immediately if you experience swelling of the face or ankles, blood in your urine, or brown-colored urine, or if you notice a decrease in the frequency of urination.
• if you experience any or a combination of the following side effects: or swelling or edema, which may be associated with less frequent urination, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of fatigue. These symptoms usually develop rapidly. These may be symptoms of a condition called "Capillary Leak Syndrome," which causes blood to leak from small blood vessels in the body and requires urgent medical attention;
• if you experience a combination of the following symptoms: or fever or chills, or feeling intensely cold, rapid heart rate, confusion or disorientation, shortness of breath, severe pain or discomfort, or sweaty and clammy skin. These may be symptoms of a condition called “sepsis” (also known as “blood poisoning”), a serious infection with an inflammatory response throughout the body that can be potentially fatal and requires urgent medical attention.
• if you experience pain in the upper left side of the abdomen (abdominal pain), pain under the left side of the rib cage, or pain at the tip of the shoulder, as there may be a problem with the spleen (splenomegaly (enlarged spleen) or splenic rupture);
• if you are being treated for severe chronic neutropenia and have blood in your urine (hematuria). Your doctor may regularly check your urine if this side effect occurs or if protein has been found in your urine (proteinuria).

A common side effect associated with the use of filgrastim is muscle or bone pain
(musculoskeletal pain) that can be relieved by taking common pain relievers
(analgesics). In patients undergoing stem cell or bone marrow transplantation, graft-versus-host
disease (GvHD) may develop: this is a reaction of the donor cells against the patient receiving the
transplant; signs and symptoms include rash on the palms of the hands or soles of the feet and ulcers and
sores in the mouth, intestines, liver, skin
or eyes, lungs, vagina and joints.
In healthy stem cell donors, an increase in white blood cells (leukocytosis) and a decrease in the number of
platelets may be detected. This reduces the blood's ability to
coagulate (thrombocytopenia). These events will be monitored by the doctor.

Very common side effects(affect more than 1 in 10 people):

• decreased platelets, which reduces the blood's ability to coagulate (thrombocytopenia)
• low red blood cell count (anemia)
• headache
• diarrhea
• vomiting
• nausea
• unusual hair loss or thinning (alopecia)
• fatigue (asthenia)
• inflammation of the lining of the digestive tract, from mouth to anus (mucosal inflammation)
• fever (pyrexia)

Common side effects(affect up to 1 in 10 people):

• lung inflammation (bronchitis)
• upper respiratory tract inflammation
• urinary tract infection
• decreased appetite
• difficulty sleeping (insomnia)
• dizziness
• reduced sensitivity, especially of the skin (hypoesthesia)
• tingling or numbness of hands or feet (paresthesia)
• low blood pressure (hypotension)
• high blood pressure (hypertension)
• cough
• coughing up blood (hemoptysis)
• pain in mouth and throat (oropharyngeal pain)
• nosebleeds (epistaxis)
• constipation
• oral pain
• enlarged liver (hepatomegaly)
• skin rash
• skin redness (erythema)
• muscle spasm
• pain during urination (dysuria)
• chest pain
• pain
• general weakness (asthenia)
• general feeling of discomfort (malaise)
• swelling of hands and feet (peripheral edema)
• increased levels of some enzymes in the blood
• changes in hematochemical values
• transfusion reaction

Uncommon side effects(affect up to 1 in 100 people):

• increased white blood cells (leukocytosis)
• allergic reaction (hypersensitivity)
• bone marrow transplant rejection (graft-versus-host disease)
• high levels of uric acid in the blood, which can cause gout (hyperuricemia) (increased blood uric acid)
• liver damage caused by blockage of the small veins inside the liver (veno-occlusive disease)
• the lungs do not function as they should, causing shortness of breath (respiratory failure)
• swelling and/or fluid in the lungs (pulmonary edema)
• inflammation of the lungs (interstitial lung disease)
• abnormal chest X-ray (pulmonary infiltrate)
• bleeding in the lungs (pulmonary hemorrhage)
• lack of oxygen absorption in the lung (hypoxia)
• irregular skin rash (maculo-papular rash)
• disease that reduces bone density, making them weaker, more fragile and prone to fractures (osteoporosis)
• reaction at the injection site

Rare side effects(affect up to 1 in 1000 people):

• severe bone, chest, bowel or joint pain (sickle cell anemia with crisis)
• sudden, life-threatening allergic reaction (anaphylactic reaction)
• pain and swelling of the joints, similar to gout (pseudogout)
• a change in the regulation of fluids in the body that can cause swelling (fluid volume alteration)
• inflammation of blood vessels in the skin (cutaneous vasculitis)
• purple-colored, raised and painful lesions on the limbs and sometimes on the face and neck, associated with fever (Sweet's syndrome)
• worsening of rheumatoid arthritis
• unusual changes in urine tests
• reduced bone density
• inflammation of the aorta (the large blood vessel that carries blood from the heart to the rest of the body), see paragraph 2
• formation of blood cells outside the bone marrow (extramedullary hematopoiesis).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. 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.

5. How to store Nivestim

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 outer packaging and
on the syringe label after the abbreviation Scad./EXP. The expiry date refers to the last
day of the month.
Store and transport in a refrigerator (2°C – 8°C). Do not freeze. Store the pre-filled syringe
in its original packaging to protect the medicine from light.
The syringe can be kept out of the refrigerator and left at room temperature for a single period
of a maximum of 15 days (however, not above 25°C).
Do not use this medicine if you notice that it is cloudy or if there are particles.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Other information

What Nivestim contains

• The active substance is filgrastim. Each millilitre contains 60 million units [MU] (600 mcg) or 96 million units [MU] (960 mcg) of filgrastim.
• Nivestim 12 MU/0.2 ml solution for injection or infusion: each pre-filled syringe contains 12 million units (MU), 120 mcg of filgrastim in 0.2 ml (corresponding to 0.6 mg/ml).
• Nivestim 30 MU/0.5 ml solution for injection or infusion: each pre-filled syringe contains 30 million units (MU), 300 mcg of filgrastim in 0.5 ml (corresponding to 0.6 mg/ml).
• Nivestim 48 MU/0.5 ml solution for injection or infusion: each pre-filled syringe contains 48 million units (MU), 480 mcg of filgrastim in 0.5 ml (corresponding to 0.96 mg/ml).
• The excipients are glacial acetic acid, sodium hydroxide, sorbitol E420, polysorbate 80, and water for injections.

Description of Nivestim and contents of the pack
Nivestim is a clear, colourless solution for injection or infusion, in a pre-filled syringe with
an injection needle (stainless steel) with protection. The needle protection contains epoxyprene,
a derivative of natural rubber latex which may come into contact with the needle.
Each pack may contain 1, 5, 8 or 10 syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Hospira Zagreb d.o.o.
Prudnička cesta 60
10291 Prigorje Brdovečko
Croatia
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 52 51 4000

България
Пфайзер Люксембург САРЛ, Клон
България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: +36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Malta
Drugsales Ltd
Tel: +356 21 419 070/1/2

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer ΕΛΛΆΣ A.E.
Τηλ: +30 210 6785 800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 55 00

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer România S.R.L.
Tel: +40 (0)21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland Unlimited
Company
Tel: +1800 633 363 (toll free)
Tel: +44 (0) 1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421–2–3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Κύπρος
Pfizer ΕΛΛΑΣ A.E. (Cyprus Branch)
Τηλ: +357 22 817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775
More detailed information on this medicine is available on the website of the European
Medicines Agency, https://www.ema.europa.eu.
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Instructions for the patient for self-injection
This paragraph contains information on how to self-inject Nivestim. It is important that you
do not attempt to self-inject the medicine before being specifically trained by your doctor or
nurse. It is also important that you dispose of the syringe in a sharps container (puncture-proof). If you have any doubts or questions about self-injection, please contact your
doctor or nurse.

How do I perform self-injection?
Normally, Nivestim is administered once a day by injection into the tissues located under the
skin, also known as a subcutaneous injection.
Learning the self-injection procedure avoids waiting at home for the nurse to arrive, or having to go to the hospital or clinic every day to receive
the injection.
You should inject yourself at the same time each day. The most suitable areas for injection are:
the front of the thigh,
the abdomen, except for the area around the navel.

It is best to change the injection site every day to avoid pain in a
specific area.

Equipment required for administration
The following equipment is required when you need to perform a subcutaneous self-injection:

• A new pre-filled syringe of Nivestim.
• A sharps container (puncture-proof) for safely disposing of used syringes.
• Disinfectant wipes (if recommended by your doctor or nurse).

How do I perform a subcutaneous self-injection of Nivestim?

• 1. Try to self-inject at approximately the same time each day.
• 2. Remove the box containing the pre-filled syringe of Nivestim from the refrigerator.
• 3. Remove the blister containing the pre-filled syringe from the box. If the box contains blisters with more than one pre-filled syringe, tear along the perforated part the part of the blister containing one pre-filled syringe, replace the rest of the blister with the syringes in the box and put the box back in the refrigerator.
• 4. Open the blister containing the pre-filled syringe by removing the cover. Remove the pre-filled syringe from the blister by holding it by the body. Do notgrip the grey needle cap or the plunger rod.

Check the syringe and make sure that the needle protection device covers the reservoir. Do not
push the needle protection device over the cap before the injection, as
this operation could activate or block the device. If the protection device
covers the needle, it means it has been activated.
Verify that the solution is clear, colourless and practically free from visible particles. Do not
inspect the product through the plastic of the safety device.
Check the date on the label to make sure the medicine has not expired.
Make sure you have a sharps container (puncture-proof)
nearby.
Allow the pre-filled syringe to reach room temperature (approximately 25 °C). This will take 15-30 minutes.
Do notremove the needle cap while the pre-filled syringe reaches
room temperature.
Do notshake the syringe.

1 Needle protection device
2 Needle cap
3 Medicine
4 Plunger rod

• Do not use the Nivestim syringe if:o The box is open or damaged. o The needle protection device is missing, detached or has been activated. o The medicine is cloudy or discoloured o There are floating particles in the liquid. o Any part of the pre-filled syringe appears cracked or broken o Some of the liquid has leaked from the syringe. o The pre-filled syringe has been dropped. The pre-filled syringe may be broken even if the break is not visible. o The needle cap is missing or not securely attached. o The expiry date printed on the label has been exceeded. In all of the above cases, discard the pre-filled syringe and use a new one.
• 5. Find a well-lit area for the injection and to check the dose that has been prescribed for you.
• 6. Wash your hands thoroughly with soap and water.
• 7. Hold the pre-filled syringe by the body of the needle protection device with the needle cap pointing upwards.
• Do nothold the syringe by the plunger head, the plunger or the needle cap.
• Do notpull the plunger back.
• Do notremove the needle cap from the pre-filled syringe until you are ready to inject the medicine.
• 8. Remove the needle cap from the syringe by holding the reservoir and carefully pulling the cap straight off, without rotating it, in a direction away from your body. Throw away the needle cap. Do notre-attach the needle cap. Do notpush the plunger, or touch the needle, or shake the syringe.

• 9. The syringe is now ready for use. It is possible that there is a small air bubble in the syringe. You do not need to remove the air bubble before the injection. Injecting the solution in the presence of an air bubble is not dangerous.
• 10. Decide where to inject Nivestim – find a spot on the front of the abdomen or the front of the thighs. Select a different injection site each time. Do notchoose an area that is sore, red, bruised or scarred. Clean the skin surface with a disinfectant wipe.
• 11. Pinch up a large fold of skin between your thumb and index finger, being careful not to touch the area you have just cleaned.

• 12. With the other hand, hold the pre-filled syringe as if you were holding a pencil. With a quick movement, as if you were throwing a dart, insert the needle under the skin at an angle of about 45° as shown.

• 13. Gently pull back on the plunger to check that no blood enters the syringe. If you see blood in the syringe, remove the needle and insert it into a different spot. Slowly press the plunger until all the contents of the syringe have been emptied.
• 14. After injecting the solution, remove the needle from the skin.
• 15. Following the instructions below, relating to the active or passive needle protection device, make sure the device covers the needle.
• 16. Do nottry to reposition the needle cap. Place the syringe in a sharps container (puncture-proof).
• Keep used syringes out of the reach and sight of children.
• Neverthrow syringes into household waste.

Remember
Most people are able to learn subcutaneous self-injection, but if
you have a lot of difficulty, do not hesitate to ask your doctor or
nurse for help and advice.

Use of the Active UltraSafe Needle Guard Device forNivestim
12 MU/0.2 ml solution for injection or infusion
The pre-filled syringe is equipped with an active needle safety device, UltraSafe Active

Needle Guard, which protects against accidental needle puncture. When handling the pre-filled syringe, keep your hands behind the needle.

• 1. Perform the injection according to the technique described above.
• 2. When you have finished the injection, slide the needle protection device forward until the needle is completely covered (the device will click into place).

Use of the UltraSafe Passive Needle Guard Device for
Nivestim 30 MU/0.5 ml injectable solution or for infusion and Nivestim 48 MU/0.5 ml injectable
solution or for infusion
The pre-filled syringe is equipped with a passive needle safety device, UltraSafe Passive

Needle Guard,which protects against accidental needle stick injury. When handling the pre-filled
syringe, keep your hands behind the needle.

• 1. Perform the injection according to the technique described above.
• 2. While holding the syringe with your fingers resting on its support edge, apply pressure to the plunger until the entire dose has been injected. The passive needle protection system will NOT activate if the ENTIRE dose has not been administered.

• 3. Remove the needle from the skin, then release the plunger and the syringe will move forward until the protection system covers the needle and locks into place.

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THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR PHYSICIANS OR
HEALTHCARE PROFESSIONALS:
Nivestim does not contain any preservative. Due to the risk of bacterial contamination, Nivestim
syringes are for single use only.
Accidental exposure to freezing temperatures for up to 24 hours has no adverse effects on the
stability of Nivestim. The frozen pre-filled syringe can be thawed and returned to the refrigerator
for subsequent use. If exposure to low temperatures exceeds 24 hours or if frozen more than once, then
Nivestim should no longer be used.
Nivestim must not be diluted in sodium chloride solution. This medicine must not be
mixed with other medicines except those described below. If not diluted as described below, filgrastim
diluted may adsorb to glass and plastic materials.
If required, Nivestim may be diluted in 5% glucose solution. Dilution to final concentrations < 0.2 MU (2 mcg) per ml is never recommended. The solution must be visually inspected
before use. Only clear solutions without visible particles should be used. For
patients treated with filgrastim diluted to concentrations less than 1.5 MU (15 mcg) per ml, human
serum albumin (HSA) must be added to a final concentration of 2 mg/ml.
Example: in a final injection volume of 20 ml, total doses of filgrastim less than 30 MU
(300 mcg) must be administered by adding 0.2 ml of a human albumin 200 mg/ml (20%) solution. When diluted with 5% glucose solution, Nivestim is compatible with glass and with
various plastic materials such as PVC, polyolefin (a copolymer of polypropylene and polyethylene) and
polypropylene.
After dilution: chemical and physical stability during use of the diluted infusion solution has been
demonstrated for 24 hours at temperatures between 2°C and 8°C. From a microbiological point of
view, the product must be used immediately. If not used immediately, the user is
responsible for the storage duration and conditions before use, which are normally not more than 24 hours
between 2°C and 8°C, unless the dilution has been carried out in controlled and validated aseptic
conditions.