What Nivestim contains
- The active substance is filgrastim. Each ml contains 60 million units [MU] (600 micrograms) or 96 million units [MU] (960 micrograms) of filgrastim.
- Nivestim 12 MU/ 0.2 ml solution for injection/ infusion: each pre-filled syringe contains 12 million units (MU), 120 micrograms of filgrastim in 0.2 ml (corresponding to 0.6 mg/ml).
- Nivestim 30 MU/ 0.5 ml solution for injection/ infusion: each pre-filled syringe contains 30 million units (MU), 300 micrograms of filgrastim in 0.5 ml (corresponding to 0.6 mg/ml).
- Nivestim 48 MU/ 0.5 ml solution for injection/ infusion: each pre-filled syringe contains 48 million units (MU), 480 micrograms of filgrastim in 0.5 ml (corresponding to 0.96 mg/ml).
- The other ingredients are acetic acid (glacial), sodium hydroxide, sorbitol E420, polysorbate 80, and water for injections.
What Nivestim looks like and contents of the packNivestim is a clear colourless solution for injection/ infusion in a glass pre-filled syringe with an injection needle (stainless steel) with a needle guard. There are 1, 5 or 10 syringes in each pack.Marketing Authorisation Holder
Hospira UK Limited
Royal Leamington Spa
Tel: +44 (0)1926 820 820
Fax: +44 (0)1926 821 041
ManufacturerPLIVA Kraków, S.A.
ul. Mogilska 80
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Hospira Benelux BVBA TélTel 32 2 332 03 15 LuxembourgLuxemburg Hospira Benelux BVBA TélTel 32 2 332 03 15
Hospira UK Limited Te. 44 0 1926 820820 Magyarország Pharmacenter Hungary Kft. Tel. 36-1-209-5927
eská republika Movianto eská republika s.r.o Tel 420 548 134 400 Malta Hospira UK Limited Tel 44 0 1926 820820
Danmark Hospira Nordic AB Tlf 46 08 672 85 00 Nederland Hospira Benelux BVBA Tel 32 2 332 03 15
Deutschland Hospira Deutschland GmbH Tel 49 0 89 43 77 77 0 Norge Hospira Nordic AB Tlf 46 08 672 85 00
Eesti Berren Medical, co Axellus OÜ Tel 372 662 3573 Österreich Astro-Pharma Vertrieb und Handel von pharmazeutischen Produkten GmbH Tel 43 01 961 93 13
Aenorasis S.A. 30 210 6136332 Polska Zaklady Farmaceutyczne S.A. Tel. 481 26178048
Portugal Hospira Portugal Lda España Hospira Productos Farmacéuticos y Hospitalarios S.L. Tel 34 914847100 Tel 351 214857434
France Hospira France Tél 33 0 826 30 03 02 România Hospira UK Limited Tel 44 0 1926 820820
Ireland Hospira Ireland Limited Tel 353 0 1 2962102 Slovenija Valentis Pharmaceuticals d.o.0 Tel 386 1 2000603
Ísland Hospira Nordic AB Sími 46 08 672 85 00 Slovenská republika Hospira UK Limited Tel 44 0 1926 820820
Italia Hospira Italia Srl Tel 39 0812405912 SuomiFinland Hospira Nordic AB PuhTel 46 08 672 85 00
Hospira UK Limited 44 0 1926 820820 Sverige Hospira Nordic AB Tel 46 08 672 85 00
Latvija Berren Medical, co Axellus SIA Tel 371 721 1629 United Kingdom Hospira UK Limited Tel 44 0 1926 820820
Berren Medical, c/o Axellus UAB
Tel: + 370 5 231 0654
This leaflet was last approved in
Information on self administration by the patientThis section contains information on how to give yourself an injection of Nivestim. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. It is also important that you dispose of the syringe in a puncture-proof container. If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
How do I administer myNivestim?
Nivestim is usually given once a day by injection, usually into the tissue just under the skin. This is known as a subcutaneous injection.
Learning to give your own injections will mean that you will not have to wait at home for a nurse to call, nor will you have to go to the hospital or clinic every day to receive your injections.
You will need to have your injections at about the same time every day. The most suitable places for injection are:
- the front of the thighs,
- the abdomen, except for the area around the navel.
It is better to change the injection site every day to avoid the risk of soreness at any one site. Equipment required for administration
To give yourself a subcutaneous injection you will need the following items:
- A new pre-filled syringe of Nivestim.
- A sharps container (puncture proof container) for disposing of used syringes safely.
- Antiseptic wipes (if recommended by your doctor or nurse). How do I give my subcutaneous Nivestim injection?
1. Try to self-inject at approximately the same time every day.
2. Remove the Nivestim from the fridge and allow it to reach room temperature (approximately 25 °C). This will take 15?30 minutes. Check the date on the pack to make sure that the medicine has not passed the expiry date. Make sure you have your sharps bin nearby.
3. Find a comfortable well lit working place to give your injection and check the dose that you have been prescribed.
4. Wash your hands thoroughly with soap and water.
5. Remove the syringe from the blister pack and check that the solution is clear, colourless and practically free from visible particles. Do not use the Nivestim if the liquid has particles floating in it or any of the liquid has leaked out of the syringe.
6. Hold the syringe with the needle pointing upwards. Remove the protective cap from the injection needle and expel any air from the syringe and needle by gently pressing the plunger upwards. The syringe is now ready for use.
7. Decide where to inject Nivestim - find a place on the front of your abdomen or the front of your thigh. Choose a different injection site each time. Do not choose an area which is tender, red, bruised or scarred. If your nurse or doctor recommends it, clean the area of skin with an antiseptic wipe.
8. Pinch a large area of skin, taking care not to touch the area you have cleaned.
9. With your other hand, insert the needle at an approximate 45- angle.
10. Pull the plunger back slightly to check if any blood appears in the syringe. If you do see blood inside the syringe, remove the needle and re-insert it in a different site. Slowly push down the plunger until all the contents of the syringe have been emptied.
11. After injecting the solution remove the needle from the skin.
12. Ensure needle guard covers the needle according to instructions for active needle guard or passive needle guard below.
13. Place the syringe into the sharps container. Do not try to replace the protective cap.
Most people can learn to give themselves a subcutaneous injection, but if you are experiencing a lot of difficulty, please do not be afraid to ask for help and advice from your doctor or nurse.
Use of Active Ultrasafe Needle GuardforNivestim 12 MU/ 0.2 ml solution for injection/ infusion The pre-filled syringe has an UltraSafe Needle Guard attached in order to protect from needle stick injury. When handling the pre-filled syringe, keep hands behind the needle.
1. Perform the injection using the technique described above.
2. When you have completed the injection, slide the needle guard forward until the needle is completely covered (device ?clicks? into place).
Use of Ultrasafe Passive Needle Guard forNivestim 30 MU/ 0.5 ml solution for injection/ infusion and Nivestim 48 MU/ 0.5 ml solution for injection/ infusion
The pre-filled syringe has an UltraSafe Needle Guard attached in order to protect from needle stick injury. When handling the pre-filled syringe, keep hands behind the needle.
1. Perform the injection using the technique described above.
2. Depress the plunger while grasping the finger flange until the entire dose has been given. The passive needle guard will NOT activate unless the ENTIRE dose has been given.
3. Remove needle from your skin, then let go of the plunger and allow syringe to move up until the entire needle is guarded and locks into place.
- Keep used syringes out of the reach and sight of children
- NEVER put used syringes into your normal household waste bin.
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:Nivestim does not contain any preservative. In view of the possible risk of microbial 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. The frozen pre-filled syringes can be thawed and then refrigerate for future use. If exposure has been greater then 24 hours or frozen more than once then Nivestim should NOT be used.
Nivestim should not be diluted with sodium chloride solution. This medicinal product must not be mixed with other medicinal products except those mentioned below. Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
If required, Nivestim may be diluted in glucose 50 mg/ml (5%) solution for infusion. Dilution to a final concentration less than 0.2 MU (2 micrograms) per ml is not recommended at any time. The solution should be visually inspected prior to use. Only clear solutions without particles should be used. For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 micrograms) per ml, human serum albumin (HSA) should 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 micrograms) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added. When diluted in glucose 50 mg/ml (5%) solution for infusion, Nivestim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.