The active ingredient is: Interferon-beta 1a 30 micrograms/0.5 ml
The other ingredients are: Sodium acetate, trihydrate; acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections.
What is in your Avonex pack
Avonex Solution for Injection comes as a ready to use injection.
In a box of Avonex there are four or twelve ready to use (pre-filled) syringes, each with 0.5 ml of a clear, colourless liquid inside. Not all pack sizes may be marketed. Each syringe is packed in a sealed plastic tray. A separate needle to give the injection is also included in the tray.
Marketing Authorisation Holder is:
Biogen Idec Limited, Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom.
Avonex is made by:
Biogen Idec BV, Robijnlaan 8, NL-2132 WX Hoofddorp, The Netherlands.
Biogen Idec Denmark Manufacturing ApS, Biogen Idec Allé 1, DK-3400 Hillerød, Denmark
You can get a larger print version of this leaflet by calling the local representatives.
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien Biogen Idec Belgium N.V.S.A. 32 2 2191218 LuxembourgLuxemburg Biogen Idec Belgium N.V.S.A. 32 2 2191218
359 2 962 12 00 Magyarország Gedeon Richter Plc. 36 1 432 6097
eská republika Biogen Idec Czech Republic 420 222 191 640 Malta Interpharma Co. Ltd. 356 21354582
Danmark Biogen Idec Denmark AS 45 77 41 57 57 Nederland Biogen Idec International B.V. 31 20 542 2000
Deutschland Biogen Idec GmbH 49 0 89 99 6170 Norge Biogen Idec Norway AS 47 23 00 52 50
Eesti Richter Gedeon Eesti filiaal 372 742 7056 Österreich Biogen Idec Austria GmbH. 43 1 484 46 13
Genesis Pharma SA 30 210 8771500 España Biogen Idec Iberia SL 34 91 310 7110 France Biogen Idec France 33 01 41 37 9595 Polska Gedeon Richter Plc. S.A. Przedstawicielstwo w Polsce. 48 22 642-67-39 Portugal Biogen Idec Portugal, Sociedade Unipessoal, Lda. 351 21 318 8450 România MEDISON PHARMA SRL 40 31 7104035
Ireland Biogen Idec Ireland Ltd. 353 01 463 7799 Slovenija Biogen Idec d.o.o. 386 1 589 91 04
Ísland Icepharma hf 354 540 8000 Slovenská republika Biogen Idec Slovak Republic s.r.o 421 2 32410188
Italia Biogen-Dompé s.r.l. 39 02 583 831 SuomiFinland Biogen Idec Finland Oy 358 207 401 200
Genesis Pharma Cyprus Ltd 3572 2 769946 Sverige BiogenIdec Sweden AB 46 8 594 113 60
Latvija Gedeon Richter Plc. 36 1 432 6097 United Kingdom Biogen Idec Limited 44 0 1628 50 1000
Gedeon Richter Plc.
+36 1 432 6097
This leaflet was last approved in
7. HOW TO INJECT AVONEX
You should have had training in how to inject Avonex
These notes are a reminder. If there?s anything you?re not sure about, check with your doctor or pharmacist.
Where to inject
- Avonex is injected into a muscle, for example, the upper thigh muscle. Injection of Avonex into the buttocks is not recommended.
- Use a different injection site each week. This means less risk of irritation to your skin and muscle.
- Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound.
A. Getting Ready
1. Remove one sealed plastic tray from the refrigerator
- Check the expiry date on the lid of the tray. Do not use it if it is out-of-date.
- Peel back the paper lid completely. Check the blister tray contains one pre-filled syringe and one injection needle (see picture ?Contents of the plastic tray?).
2. Leave the syringe to warm up
- Leave it at room temperature for half an hour. This makes the injection more comfortable than injecting straight from the fridge. Tip: Do not use external heat sources such as hot water to warm the syringe.
3. Wash your hands thoroughly with soap and water and dry them.
4. Prepare alcohol wipes and sticking plasters (not supplied) if you need them.
Find a clean, hard surface to lay out the items needed for your injection. Lay the tray down on it.
B. Preparing the injection
1 Check the liquid in the syringe It should be clear and colourless. If the solution is cloudy, coloured or contains any floating particles, do not use the pre-filled syringe.
2 Remove the syringe cap The syringe has a white tamper-evident cap. Make sure the cap is intact and has not been opened. If it looks like it has been opened, do not use that syringe. Hold the syringe so that the white cap is facing up. Bend the cap at a right angle until it snaps off. Do not touch the connection port. Do not push on the plunger.
3 Fit the needle Open needle to expose the connection port. Keep the cover on. Press the needle onto the syringe. Turn it clockwise until it locks into place. Tip Make sure the injection needle is firmly attached to the syringe. Otherwise it may leak. If you have been prescribed a half dose of Avonex, you may need to use the Avostartclip your doctor will provide. Please follow the instructions provided with the Avostartclip. Now pull off the plastic needle cover. Do not twist it. Tip If you twist the needle cover to remove it, you may accidentally remove the needle as well.
C. Giving the injection
1 Clean and stretch the injection site If you need to, use an alcohol wipe to clean the skin at the injection site youve chosen. Allow the skin to dry. With one hand, stretch the skin around the injection site. Relax your muscle.
2 Make the injection Insert the injection needle with a quick dart-like thrust at right angles to the skin, into the muscle. The needle must go all the way in. Press the plunger slowly until the syringe is empty. If you are using the syringe that has the Avostartclip attached, you will receive about half the dose of Avonex. The syringe will not empty.
3 Pull the needle out Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle. If you use alcohol wipes, hold one on the injection site. Put a plaster over the site of injection if you need to.
Dispose of the rubbish properly After you have finished each injection, put the needle and syringe into a special container such as a sharps bin, not in ordinary rubbish. If you have used the Avostartclip, the syringe and the Avostartclip must be thrown away afterwards. The unused portion of Avonex must not be re-used. Waste paper and used wipes can be put in an ordinary rubbish bin.