What Aranesp contains
- The active substance is darbepoetin alfa.The pre-filled syringe contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.
- The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.
What Aranesp looks like and contents of the pack
Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled syringe.
Aranesp is available in packs of 1 or 4 pre-filled syringes with automatic needle guard in a blister wrapping. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Amgen Europe B.V.
NL-4817 ZK Breda
If you want more information about this medicine, please contact the local representative of the company that is authorised to market Aranesp.
BelgiëBelgiqueBelgien s.a. Amgen n.v. TelTél 32 02 7752711 LuxembourgLuxemburg s.a. Amgen BelgiqueBelgien TelTél 32 02 7752711
359 02 805 7020 Magyarország Amgen Kft. Tel. 36 1 35 44 700
eská republika Amgen s.r.o. Tel 420 2 21 773 500 Malta Amgen B.V. The Netherlands Tel 31 076 5732500
Danmark Amgen filial af Amgen AB, Sverige Tlf 45 39617500 Nederland Amgen B.V. Tel 31 076 5732500
Deutschland AMGEN GmbH Tel. 49 089 1490960 Norge Amgen AB Tel 47 23308000
Eesti Amgen Switzerland AG Eesti filiaal Tel 372 512 5501 Österreich Amgen GmbH Tel 43 01 50 217
Genesis Pharma S.A. 30 210 8771500 Polska Amgen Sp. z o.o. Tel. 48 22 581 3000
España Amgen S.A. Tel 34 93 600 19 00 Portugal AMGEN Biofarmacêutica, Lda. Tel 351 21 4220550
France Amgen S.A.S. Tél 33 01 40 88 27 00 România Amgen România SRL Tel. 4021 527 30 00
Slovenija AMGEN zdravila d.o.o. Tel 386 1 585 1767 Ireland Amgen Limited United Kingdom Tel 44 01223 420305
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Amgen Switzerland AG, Slovakia Tel 421 33 321 13 22
Italia Amgen Dompé S.p.A. Tel 39 02 6241121 SuomiFinland Amgen AB, sivuliike SuomessaAmgen AB, filial i Finland PuhTel 358 09 54900500
K Genesis Pharma Cyprus Ltd 357 22 76 99 46 Sverige Amgen AB Tel 46 08 6951100
Latvija Amgen Switzerland AG Rgas filile Tel 371 29284 807 United Kingdom Amgen Limited Tel 44 01223 420305
Amgen Switzerland AG Vilniaus filialas
Tel: +370 6983 6600
This leaflet was last approved in
INSTRUCTIONS FOR INJECTING WITH THE ARANESP PRE-FILLED SYRINGE
This section contains information on how you, or the person injecting you, use the Aranesp pre-filled syringe. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
Before you begin
Read all instructions thoroughly before using the pre-filled syringe.
To reduce the risk of accidental needle sticks to users, each pre-filled syringe is equipped with a needle guard that is automatically activated to cover the needle after complete delivery of the pre-filled syringe content.
DO NOT attempt to activate the needle guard prior to injection.
The pre-filled syringe barrel has a detachable label that can be pulled off after injection. The label is used by healthcare professionals to update a patient?s chart.
DO NOT use the pre-filled syringe if the needle cover has been removed, or the needle guard has been activated (covering the needle).
DO NOT try to remove the detachable label on the pre-filled syringe barrel before administering the injection.
How do I use the Aranesp pre-filled syringe?
Your doctor has prescribed an Aranesp pre-filled syringe for injection into the tissue just under the skin. Your doctor, nurse, or pharmacist will tell you how much Aranesp you need and how frequently it should be injected.
To give yourself an injection you will need:
- a new Aranesp pre-filled syringe; and
- alcohol wipes or similar.
What should I do before I give myself a subcutaneous injection of Aranesp?
1. Remove the pre-filled syringe from the refrigerator. Do not
pick up the pre-filled syringe by the plunger or needle cover. This could damage the device.
2. Leave the pre-filled syringe at room temperature for approximately 30 minutes. This will make the injection more comfortable. Do not warm Aranesp in any other way (for example, in a microwave or in hot water). Do not leave the syringe exposed to direct sunlight.
3. Do not shake the pre-filled syringe.
4. Do not remove the cover from the pre-filled syringe until you are ready to inject.
5. Check that it is the correct dose that your doctor has prescribed.
6. 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.
7. Check the appearance of Aranesp. It must be a clear, colourless or slightly pearly liquid. If it is cloudy or there are particles in it, you must not use it.
8. Wash your hands thoroughly.
9. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Where should I give my injection The best places to inject yourself are the top of your thighs and the abdomen. If someone else is injecting for you, they can also use the back of your arms. Change the injection site if you notice the area is red or sore.
How do I give my injection 1. Disinfect your skin by using an alcohol wipe. 2. To avoid bending the needle, gently pull the cover from the needle straight off without twisting as shown. Do not touch the needle or push the plunger. 3. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
4. Pinch (without squeezing) the skin between your thumb and forefinger. Put the needle fully into the skin as shown by your nurse or doctor.
5. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, pull the needle out and re-insert it in another place after disinfecting the skin.
6. Push the plunger with a slow constant pressure, always keeping your skin pinched.
Push the plunger all the way down as far as it will go to inject all the liquid. The needle guard will not activate unless you empty the pre-filled syringe.
7. While the plunger is still pressed all the way down, remove the needle from the skin, then release the plunger and allow the syringe to move up until the entire needle is covered by the needle guard. If the needle guard is not activated, an incomplete injection may have occurred. Call your health care provider if you think you have not received the full dose. DO NOT put the needle cover back on the needle.
8. If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site.If needed, you may cover the injection site with a plaster.
9. Only use each pre-filled syringe for one injection. Do not use any Aranesp that is left in the syringe.
Remember: If you have any problems, please ask your doctor or nurse for help and advice.
Disposing of used syringes
- DO NOT put the needle cover back on used syringes.
- Keep used syringes out of the reach and sight of children.
- The used syringe should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.--------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
How to remove the detachable label
The Aranesp pre-filled syringe comes with a detachable label that can be removed and placed on a patient?s chart.
NOTE: Only perform this step after you have given the injection and the safety guard is covering the needle.
1. Hold the syringe as shown and rotate the plunger towards you until you can see the tab of
the label within the opening of the window as shown below.
2. Slightly rotate the plunger away from you until the tab sticks up through the window as shown below.
3. Pull the tab up through the window, and then tear across the perforation, as shown below.
Tear at perforation