Nivestim 30 MU/0.5 ml solution for injection and infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nivestim 12MU/0.2ml solution for injection and infusion

Nivestim 30MU/0.5ml solution for injection and infusion

Nivestim 48MU/0.5ml solution for injection and infusion

filgrastim

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Nivestim is and what it is used for
2. What you need to know before using 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 that occur naturally in the body, but can also be produced using genetic engineering for use as a medicine. Nivestim works by stimulating the bone marrow to produce more white blood cells.

A reduction in the number of white blood cells (neutropenia) may occur for various reasons and makes your body less effective at fighting infections. Nivestim stimulates the bone marrow to rapidly produce new white blood cells.

Nivestim may be used:

• to increase the number of white blood cells after chemotherapy treatment, to help prevent infections;
• to increase the number of white blood cells after a bone marrow transplant, to help prevent infections;
• prior to high-dose chemotherapy to stimulate the bone marrow to produce more stem cells, which can be collected and re-administered to you after treatment. These cells may be collected 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, to help prevent infections;
• to help reduce the risk of infections in patients with advanced HIV infection.

2. What you need to know before using Nivestim

Do not use Nivestim

• if you are allergic to filgrastim or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Nivestim.

Inform your doctor before starting treatment if you have:

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

Immediately inform your doctor during treatment with Nivestim if:

• you experience sudden signs of allergy such as rash, itching, hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing, or difficulty breathing, as these could be signs of a serious allergic reaction (hypersensitivity);

• you develop swelling in the face or ankles, blood in the urine, or brown-colored urine, or if you notice that you are urinating less frequently than usual (glomerulonephritis);

• you experience pain in the upper left part of the abdomen, pain below the left rib cage, or pain at the left end of the shoulder (these may be symptoms of an enlarged spleen [splenomegaly] or possible spleen rupture);

• you notice unusual bleeding or bruising (these may be symptoms of a low platelet count in the blood [thrombocytopenia], resulting in reduced blood clotting ability).

• Rarely, inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body) has been reported in cancer patients and in healthy donors. Symptoms may include fever, abdominal pain, general malaise, back pain, and increased inflammatory markers. Inform your doctor if you experience any of these symptoms.

Loss of response to filgrastim

If you experience a loss of response to filgrastim or fail to maintain the treatment response, your doctor will investigate possible causes, including whether you have developed antibodies that may neutralize the activity of filgrastim.

Your doctor may wish 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 blood cancer (leukemia, myelodysplastic syndrome [MDS]). Discuss with your doctor the risks of developing blood cancer and the tests that should be performed. You should not use Nivestim if you have or are likely to develop blood cancers, unless otherwise directed by your doctor.

If you are a stem cell donor, you must be between 16 and 60 years of age.

Take special care with other products that stimulate white blood cells

Nivestim belongs to a group of medicines that stimulate the production of white blood cells. Your doctor must always record the exact product you are using.

Using Nivestim with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

Nivestim has not been studied in pregnant or breastfeeding women.

The use of Nivestim during pregnancy is not recommended.

It is important that you inform your doctor if you:

• are pregnant or breastfeeding;
• think you may be pregnant; or
• plan to become pregnant.

If you become pregnant while being treated with Nivestim, inform your doctor.

Unless your doctor advises otherwise, you must stop breastfeeding if you are using Nivestim.

Driving and using machines

The effect of Nivestim on your ability to drive and operate machinery is minimal. This medicine may cause dizziness. It is advisable to wait and observe how you feel after receiving Nivestim before driving or operating machinery.

Nivestim contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.6 mg/ml or 0.96 mg/ml dose; hence, it is essentially "sodium-free".

Nivestim contains sorbitol

This medicine contains 50 mg of sorbitol in each ml.

Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, this medicine must not be administered. Patients with HFI cannot break down fructose, which may lead to serious adverse effects.

Consult your doctor before receiving this medicine if you (or your child) have HFI or if your child cannot consume sweet foods or drinks because they cause dizziness, vomiting, or unpleasant effects such as bloating, stomach cramps, or diarrhea.

3. How to use Nivestim

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor, nurse, or pharmacist again.

How is Nivestim administered and how much should I take?

Nivestim is usually given once daily as an injection into the tissue just beneath the skin (known as a subcutaneous injection). It may also be given once daily as a slow injection into the vein (known as intravenous infusion). The usual dose depends on your condition and body weight. Your doctor will tell you how much Nivestim you should take.

Patients undergoing bone marrow transplantation after chemotherapy:

You will normally receive your first dose of Nivestim at least 24 hours after chemotherapy and at least 24 hours after receiving your bone marrow transplant.

You or your caregivers may be taught how to administer subcutaneous injections so that you can continue treatment at home. However, you must not attempt this unless you have been properly trained by a healthcare professional.

How long should I take Nivestim?

You will need to take Nivestim until your white blood cell count returns to normal. You will have regular blood tests to monitor the number of white blood cells in your body. Your doctor will tell you how long you need to continue taking Nivestim.

Use in children

Nivestim is used to treat children who are receiving chemotherapy or who have severe low white blood cell count (severe neutropenia). The dose for children receiving chemotherapy is the same as that for adults.

If you use more Nivestim than you should

Do not increase the dose prescribed by your doctor. If you think you have injected more than the prescribed amount, contact your doctor as soon as possible.

If you forget to use Nivestim

If you have missed an injection or injected a lower dose, contact your doctor as soon as possible. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell your doctor immediately during treatment:

• if you experience an allergic reaction, including weakness, low 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 signs 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 notice swelling in your face or ankles, blood in your urine, brown-colored urine, or if you urinate less frequently than usual;

• if you experience any of the following adverse effects or a combination of them:

• swelling, which may be associated with reduced urination, difficulty breathing, abdominal swelling and fullness, and a general feeling of fatigue. These symptoms usually develop very rapidly.

These may be symptoms of a condition called "capillary leak syndrome," which causes blood to leak from small blood vessels into other areas of your body and requires urgent medical attention.

• if you experience a combination of the following symptoms:

• fever, chills, or feeling very cold, rapid heart rate, confusion or disorientation, difficulty breathing, extreme pain or discomfort, and wet or sweaty skin.

These could be symptoms of a condition called "sepsis" (also known as "blood poisoning"), a serious infection with a systemic inflammatory response that can be potentially life-threatening and requires urgent medical attention.

• if you experience pain in the upper left part of the abdomen, pain in the lower left side of the rib cage, or shoulder tip pain, as these may indicate a problem with your spleen (enlargement of the spleen [splenomegaly] or rupture of the spleen);
• if you are being treated for severe chronic neutropenia and have blood in your urine (hematuria). Your doctor will perform periodic urine tests if you experience this adverse effect or if proteins are found in your urine (proteinuria).

A common adverse effect of using filgrastim is muscle or bone pain (musculoskeletal pain), which can be relieved by taking usual pain medications (analgesics). In patients undergoing stem cell or bone marrow transplantation, graft-versus-host disease (GVHD) may occur. This is a reaction of donor cells against the patient receiving the transplant; signs and symptoms include rashes on the palms of the hands or soles of the feet, and ulcers and sores in the mouth, intestine, liver, skin, eyes, lungs, vagina, and joints.

In healthy stem cell donors, an increase in white blood cells (leukocytosis) and a decrease in platelets may be observed. This reduces your blood's ability to clot (thrombocytopenia). These effects will be monitored by your doctor.

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

• Decrease in platelets, reducing the blood’s ability to clot (thrombocytopenia)
• Low red blood cell count (anemia)
• Headache
• Diarrhea
• Vomiting
• Nausea
• Unusual hair loss or thinning (alopecia)
• Tiredness (fatigue)
• Irritation and swelling of the lining of the digestive tract, from mouth to anus (mucositis)
• Fever (pyrexia)

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

• Inflammation of the lungs (bronchitis)
• Upper respiratory tract infection
• Urinary tract infection
• Decreased appetite
• Trouble sleeping (insomnia)
• Dizziness
• Decreased sensation, especially in the skin (hypoesthesia)
• Tingling or numbness in hands or feet (paresthesia)
• Low blood pressure (hypotension)
• High blood pressure (hypertension)
• Cough
• Coughing up blood (hemoptysis)
• Pain in mouth and throat (oropharyngeal pain)
• Nosebleed (epistaxis)
• Constipation
• Mouth pain
• Enlargement of the liver (hepatomegaly)
• Rash
• Redness of the skin (erythema)
• Muscle cramps
• Pain when urinating (dysuria)
• Chest pain
• Pain
• Generalized weakness (asthenia)
• Feeling unwell (malaise)
• Swelling in hands and feet (peripheral edema)
• Increase in certain enzymes in the blood
• Changes in blood biochemical tests
• Transfusion reaction

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

• Increase in white blood cells in the blood (leukocytosis)
• Allergic reaction (hypersensitivity)
• Rejection of bone marrow transplant (graft-versus-host disease)
• High levels of uric acid in the blood, which may cause gout (hyperuricemia) (elevated uric acid in blood)
• Liver damage caused by blockage of small liver veins (veno-occlusive disease)
• Lungs not functioning properly, causing shortness of breath (respiratory failure)
• Swelling or fluid in the lungs (pulmonary edema)
• Inflammation of the lungs (interstitial lung disease)
• Abnormal lung X-rays (pulmonary infiltration)
• Bleeding from the lungs (pulmonary hemorrhage)
• Poor oxygen absorption in the lungs (hypoxia)
• Irregular skin rash (maculopapular rash)
• A disease causing bones to lose density, making them weaker, more fragile, and more prone to fracture (osteoporosis)
• Injection site reaction

Rare adverse effects (may affect up to 1 in 1,000 people):

• Severe pain in bones, chest, intestines, or joints (sickle cell anemia with crisis)
• Sudden, potentially life-threatening allergic reactions (anaphylactic reaction)
• Swelling and pain in the joints, similar to gout (pseudogout)
• A change in the way your body regulates body fluids, which may result in swelling (fluid volume alterations)
• Inflammation of blood vessels in the skin (cutaneous vasculitis)
• Painful, inflamed, dark red ulcers on the limbs, and sometimes on the face and neck, accompanied by fever (Sweet’s syndrome)
• Worsening of rheumatoid arthritis
• Unusual changes in urine
• Decreased bone density
• Inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), see section 2.
• Formation of blood cells outside the bone marrow (extramedullary hematopoiesis).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nivestim

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the label of the pre-filled syringe after EXP. The expiry date refers to the last day of the month indicated.

Store and transport refrigerated (between 2°C and 8°C). Do not freeze. Keep the pre-filled syringe in the outer packaging to protect it from light.

The syringe may be removed from the refrigerator and kept at room temperature for a single period of up to 15 days (but at a temperature not exceeding 25°C).

Do not use this medicine if you notice that the solution in the syringe is cloudy or contains particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nivestim

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

Appearance of the product and contents of the pack

Nivestim is a clear, colourless solution for injection/perfusion supplied in a pre-filled syringe with an injection needle (stainless steel) and a needle shield. The needle cap contains epichlorohydrin rubber, a derivative of natural rubber latex, which may come into contact with the needle.

Nivestim is available in packs containing 1, 5, 8 or 10 pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer

Hospira Zagreb d.o.o.
Prudnicka cesta 60
10291 Prigorje Brdovecko
Croatia

For further information on this medicinal product, please contact the local representative of the marketing authorisation holder:

Belgium/Belgium/Belgium Luxembourg/Luxembourg Pfizer NV/SA Tel/Tel: +32 (0)2 554 62 11	Lithuania Pfizer Luxembourg SARL branch in Lithuania Tel: +370 52 51 4000
	Hungary Pfizer Kft. Tel.: +36 1 488 37 00
Czech Republic Pfizer, spol. s r.o. Tel: +420-283-004-111	Malta Drugsales Ltd Tel: +356 21 419 070/1/2
Denmark Pfizer ApS Tlf.: +45 44 20 11 00	Netherlands Pfizer bv Tel: +31 (0)800 63 34 636
Germany PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51000	Norway Pfizer AS Tlf: +47 67 52 61 00
Estonia Pfizer Luxembourg SARL Estonia branch Tel: +372 666 7500	Austria Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0
Greece Pfizer HELLAS S.A. Tel: +30 210 6785 800	Poland Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
Spain 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	Romania Pfizer România S.R.L. Tel: +40 (0)21 207 28 00
Croatia Pfizer Croatia d.o.o. Tel: +385 1 3908 777	Slovenia Pfizer Luxembourg SARL Pfizer, branch for consulting in the field of pharmaceutical activities, 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	Slovakia Pfizer Luxembourg SARL, organizational unit Tel: +421–2–3355 5500
Iceland Icepharma hf. Sími: +354 540 8000	Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040
Italy Pfizer S.r.l. Tel: +39 06 33 18 21	Sweden Pfizer AB Tel: +46 (0)8 550 520 00
Cyprus Pfizer HELLAS S.A. (Cyprus Branch) Tel: +357 22 817690	Latvia Pfizer Luxembourg SARL filiale Latvija Tel: + 371 670 35 775

Date of the most recent review of this leaflet: {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

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Patient self-injection instructions

This section contains information on how to administer an injection of Nivestim yourself. It is important that you do not attempt to give yourself the injection unless your doctor or nurse has first explained how to do so. It is also important that you dispose of syringes in a sharps container (puncture-proof). If you are unsure about whether you wish to administer the injection yourself or have any questions, consult your doctor or nurse.

How should I inject Nivestim?

Nivestim is usually administered once daily by injection, typically into the tissue beneath the skin. This is known as a subcutaneous injection.

By learning how to administer the injection yourself, you will no longer need to wait at home for a nurse to visit or go to the hospital or clinic every day to receive your injection.

You should administer your injection at approximately the same time each day. The most suitable injection sites are:

• The front of the thighs
• The abdomen, except the area around the navel

It is best to change the injection site each day to minimize the risk of discomfort at any one site.

Equipment required for administration:

The following items are needed to administer the subcutaneous injection:

1. One new pre-filled syringe of Nivestim
2. A sharps container (puncture-proof) for the safe disposal of used syringes
3. Antiseptic wipes (if recommended by your doctor or nurse)

How to administer the subcutaneous injection of Nivestim:

1. Administer the injection at approximately the same time each day.
2. Remove the carton containing the pre-filled syringe of Nivestim from the refrigerator.
3. Remove the blister containing the pre-filled syringe from the carton. If the carton contains multiple pre-filled syringes in blisters, cut off the blister with one pre-filled syringe along the perforated line, return the remaining blisters with pre-filled syringes to the carton, and place the carton back in the refrigerator.
4. Open the blister containing the pre-filled syringe by removing the blister lid. Remove the pre-filled syringe from the blister by holding it by the syringe barrel.
   • Do not touch the grey needle cap or the plunger.

Check the syringe to ensure that the needle safety shield covers the body of the pre-filled syringe. Do not push the needle safety shield over the needle cap before injection. This may activate or lock the needle safety shield. If the needle safety shield covers the needle, this indicates that it has been activated.

Inspect the solution to confirm it is clear, colourless, and practically free from visible particles. Do not inspect the product through the plastic of the safety device.

Check the expiry date on the label to ensure the medicine has not expired.

Ensure that a sharps container (puncture-proof) is within reach.

Allow the pre-filled syringe to reach room temperature (approximately 25 °C). This will take 15–30 minutes.

• Do not remove the needle cap from the syringe while allowing the pre-filled syringe to reach room temperature.
• Do not shake the syringe.

1	Safety shield for the needle
2	Needle cap
3	Medication
4	Plunger

• Do not use the Nivestim syringe if:

• The cardboard package is open or damaged.

• The needle safety shield is missing, has detached, or has been activated.

• The medicine is cloudy, has changed color, or the liquid contains floating particles.

• Any part of the pre-filled syringe appears cracked or broken, or liquid has leaked from the syringe.

• The pre-filled syringe has been dropped. The pre-filled syringe may be broken even if you cannot see the break.

• The needle cap is missing or not properly attached.

• The expiry date printed on the label has passed.

In all of the above cases, discard the pre-filled syringe and use a new pre-filled syringe.

1. Find a comfortable place to administer your injection and verify the dose prescribed to you.

2. Wash your hands thoroughly with soap and water.

3. Hold the pre-filled syringe by the body of the needle safety shield with the needle cap pointing upwards.

   • Do not hold by the plunger head, plunger, or needle cap.
   • Do not pull back on the plunger at any time.
   • Do not remove the needle cap from the pre-filled syringe until you are ready to inject your medicine.

4. Remove the needle cap from the syringe by holding the syringe body and carefully pulling the needle cap straight outward and away from your body without twisting. Discard the needle cap. Do not recap the needle. Do not push the plunger, touch the needle, or shake the syringe.

1. The syringe is now ready to use. You may observe a small air bubble in the syringe. There is no need to expel the air bubble before injecting the solution. Injecting the solution with an air bubble is harmless.
2. Decide where you will administer the injection—choose a site on the front of your abdomen or the front of your thighs. Select a different injection site each time. Do not choose an area that is tender, red, damaged, or scarred. Clean this area of skin with an antiseptic swab.
3. Pinch a large area of skin, taking care not to touch the area you cleaned.

12 With your other hand, hold the pre-filled syringe like a pencil. Use a quick “dart-like” motion to insert the needle into the skin at an approximate 45º angle as shown.

1. Gently pull back on the plunger to confirm you have not punctured a blood vessel. If you see blood in the syringe, withdraw the needle and insert it into another site. While keeping the skin pinched, slowly and steadily push the plunger until the syringe is empty.
2. After injecting the solution, remove the needle from the skin.
3. Ensure the syringe shield covers the needle according to the instructions for either the active needle safety shield or passive needle safety shield described below.
4. Do not attempt to recap the needle. Place the syringe into a sharps container (puncture-resistant).

• Keep used syringes out of the reach and sight of children.
• Never place used syringes in regular household waste.

Remember

Most people can learn to self-administer subcutaneous injections, but if you find it very difficult, do not hesitate to ask your doctor or nurse for help and advice.

Use of the Active Ultra-Safe Needle Shield for Nivestim 12MU/0.2ml injectable solution and for infusion

The pre-filled syringes are equipped with an Active Ultra-Safe Needle Shield to protect you from needlestick injuries. When handling a pre-filled syringe, keep your hands behind the needle.

1. Administer the injection using the technique described above.
2. After completing the injection, slide the needle into the safety shield until the needle is completely covered (you will hear a “click”).

Use of the Passive Ultra-Safe Needle Shield for Nivestim 30MU/0.5ml injectable solution / infusion and Nivestim 48MU/0.5ml injectable solution / infusion

The pre-filled syringes are equipped with a Passive Ultra-Safe Needle Shield to protect you from needlestick injuries. When handling a pre-filled syringe, keep your hands behind the needle.

1. Administer the injection using the technique described above.

2. Press the plunger while holding the syringe with your fingers until the full dose has been administered. The passive syringe shield will NOT activate until the ENTIRE dose has been delivered.

1. Remove the needle from your skin; the plunger will move and allow the syringe to move upward until the needle is retracted and locked in place.

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This information is intended for healthcare professionals only:

Nivestim does not contain preservatives: due to the potential risk of microbiological contamination, Nivestim syringes are for single use only.

Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Nivestim. Pre-filled syringes that have been frozen may be thawed and then refrigerated for future use. If exposure exceeds 24 hours or if the syringes have been frozen more than once, Nivestim must NOT be used.

Nivestim must not be diluted with sodium chloride solutions. This medicinal product must not be mixed with other medicinal products except as mentioned below. Diluted filgrastim may be adsorbed onto plastic or glass materials unless diluted as described below.

Nivestim may, if necessary, be diluted in 5% glucose solution. Dilution to final concentrations below 0.2 MU (2 µg) per millilitre is not recommended. The solution should be inspected visually before use. Only clear solutions without particles should be used. In patients treated with filgrastim diluted to concentrations below 1.5 MU/ml (15 µg per millilitre), human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.

Example: if the final injection volume is 20 ml and the total filgrastim dose is less than 30 MU (300 µg), add 0.2 ml of a 200 mg/ml (20%) human serum albumin solution. When diluted in 5% glucose solution, Nivestim is compatible with glass and various plastics, including polyvinyl chloride, polyolefin (a copolymer of polypropylene and polyethylene), and polypropylene.

After dilution: it has been demonstrated that the diluted infusion solution remains physicochemically stable for 24 hours at 2–8°C during use. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should generally not exceed 24 hours at 2–8°C, unless dilution has been carried out under validated and controlled aseptic conditions.