What Ratiograstim contains
- The active substance is filgrastim. Each ml of solution for injection or infusion contains 60 million international units [MIU] (600 µicrogram) of filgrastim.Ratiograstim 30 MIU/0.5 ml: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 ml solution. Ratiograstim 48 MIU/0.8 ml: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 ml solution.
- The other ingredients are: Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections. You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading ?Important information about some of the ingredients of Ratiograstim?.
What Ratiograstim looks like and contents of the pack
Ratiograstim is a solution for injection or infusion in a pre-filled syringe with or without safety device. Ratiograstim is a clear and colourless solution. Each pre-filled syringe contains 0.5 ml or 0.8 ml of solution.
Ratiograstim are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes. Not all pack sizes may be marketed.
Marketing Authorisation Holderratiopharm GmbH
Merckle Biotec GmbH
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien ratiopharm Belgium S.A. TélTel 32 2 761 10 11 LuxembourgLuxemburg ratiopharm S.A. Luxemburg TélTel 35 2 40 37 27
ratiopharm GmbH, Te 49 731 402 02 Magyarország ratiopharm Hungária Kft. Tel 36 1 273 2730
eská republika ratiopharm CZ s.r.o. Tel 420 2 510 21 122 Malta ratiopharm GmbH, Il ermanja Tel 49 731 402 02
Danmark ratiopharm AS Tlf 45 45 46 06 60 Nederland ratiopharm Nederland bv Tel 31 23 7070 840
Deutschland ratiopharm GmbH Tel 49 731 402 02 Norge ratiopharm AS Tlf 47 66 77 55 90
Eesti ratiopharm Eesti büroo Tel 372 6838 006 Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel 43 1 97 007
ratiopharm GmbH, 49 731 402 02 Polska ratiopharm Polska Sp.z.o.o Tel 48 22 335 39 20
España ratiopharm España, S.A. Division ratiopharm direct Tel 34 91 567 29 70 Portugal ratiopharm, Comércio e Indústria de Produtos farmacêuticos Lda Tel 351 21 424 80 00
France Laboratoire ratiopharm S.A. Tél 33 1 42 07 97 04 România ratiopharm GmbH, Germania Tel 49 731 402 02
Ireland ratiopharm UK Ltd, United Kingdom Tel 44 239 238 6330 Slovenija ratiopharm GmbH, Nemija Tel 49 731 402 02
Ísland ratiopharm GmbH, skaland Sími 49 731 402 02 Slovenská republika ratiopharm Slovensko s.r.o. Tel 421 2 57 200 300
SuomiFinland ratiopharm Oy PuhTel 358 20 180 5900 Italia ratiopharm Italia s.r.l. Division ratiopharm direct Tel 39 02 28 87 71
ratiopharm GmbH, 49 731 402 02 Sverige ratiopharm AB Tel 46 42 37 0740
Latvija ratiopharm Latvijas prstvniecba Tel 371 67499110 United Kingdom ratiopharm UK Ltd Tel 44 239 238 6330
ratiopharm atstovas Lietuvoje
Tel: + 370 5 212 3295
This leaflet was last approved in
INFORMATION FOR INJECTING YOURSELF
This section contains information on how to give yourself an injection of Ratiograstim. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
Ratiograstim is supplied in pre-filled syringes either with or without safety device. The figures below refer either to syringes with safety device (figures 2a, 2b, 7 and 8) or without (figures 1a and 1b). The other figures (3, 4, 5, 6) apply to both syringes. Your doctor or pharmacist can tell you which pre-filled syringe you have received. It is important that you dispose of the syringe without safety device in a puncture-proof container.
How do I inject Ratiograstim myself?
You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection. You will need to have your injections at about the same time every day.
Equipment that you need
To give yourself a subcutaneous injection you will need:
- a pre-filled syringe of Ratiograstim,
- alcohol wipes or similar,
- a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes without safety device safely.
What should I do before I give myself a subcutaneous injection of Ratiograstim?
1. Try to self-inject at approximately the same time every day.
2. Take your Ratiograstim pre-filled syringe out of the refrigerator.
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
4. Check the appearance of Ratiograstim. It must be a clear and colourless liquid. If there are particles in it, you must not use it.
5. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Ratiograstim in any other way (for example, do not warm it in a microwave or in hot water).
6. Do not remove the cover from the syringe until you are ready to inject.
7. Wash your hands thoroughly.
8. Find a comfortable, well-lit place and put everything you need where you can reach them (the Ratiograstim pre-filled syringe, alcohol wipes and the puncture-proof container).
How do I prepare my Ratiograstim injection?
Before you inject Ratiograstim you must do the following:
1. Hold the syringe and gently take the cover from the needle without twisting. Pull straight as shown in pictures 1 and 2 (see pictures 1a and 1b for syringes without safety device and pictures 2a and 2b for syringes with safety device). Do not touch the needle or push the plunger.
1a 1b Without safety device
2a 2b With safety device
2. You may notice a small air bubble in the pre-filled syringe. If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With the syringe pointing upwards, expel all air from the syringe by pushing the plunger upwards.
3. The syringe has a scale on the syringe barrel. Push the plunger up to the number (ml) on the syringe that matches the dose of Ratiograstim that your doctor prescribed.
4. Check again to make sure the correct dose of Ratiograstim is in the syringe.
5. You can now use the pre-filled syringe.
Where should I give my injection?
The most suitable places to inject yourself are:
- the top of your thighs; and
- the abdomen, except for the area around the navel (see picture 3).
If someone else is injecting you, they can also use the back of your arms (see picture 4).
It is better to change the injection site every day to avoid the risk of soreness at any one site.
How do I give my injection?
1. Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
2. Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).
3. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
4. Inject the liquid slowly and evenly, always keeping your skin pinched.
5. Inject only the dose your doctor has told you.
6. Syringe without safety device: After injecting the liquid, remove the needle and let go of your skin. Syringe with safety device: Remove the syringe from the injection site while keeping your finger on the plunger (see picture 7). Orient the needle away from you and others and activate the safety device by firmly pushing the plunger (see picture 8). You will hear a ?click?, which confirms activation of the safety device. The needle will be covered by the protective sleeve so that you cannot prick yourself.
7. Only use each syringe for one injection. Do not use any Ratiograstim that is left in the syringe.
7 8 With safety device
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Disposing of used syringes
Syringes without safety device:
- Do not put the cover back on used needles.
- Put used syringes into the puncture-proof container and keep this container out of the reach and sight of children.
- Dispose of the full puncture-proof container as instructed by your doctor, nurse or pharmacist.
- Never put the syringes that you have used into your normal household rubbish bin. Syringes with safety device:
- The safety device prevents needle stick injuries after use, so no special precautions for disposal are required. Dispose of syringes with safety device as instructed by your doctor, nurse or pharmacist.
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY
Ratiograstim does not contain any preservative. In view of the possible risk of microbial contamination, Ratiograstim syringes are for single use only.
Accidental exposure to freezing temperatures does not adversely affect the stability of Ratiograstim.
Ratiograstim 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, Ratiograstim may be diluted in glucose 50 mg/ml (5%) solution for infusion. Dilution to a final concentration less than 0.2 MIU (2 ?g) 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 MIU (15 ?g) 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 MIU (300 ?g) 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, Ratiograstim 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.