The active ingredient is: Interferon-beta 1a 30 micrograms
The other ingredients are: Human serum albumin, sodium chloride, dibasic sodium phosphate and monobasic sodium phosphate.
What is in your Avonex pack
A box of Avonex Bioset has four doses of Avonex.
Each dose comes in a sealed plastic tray and has a white to off-white coloured powder in a glass container (vial) and an injection syringe filled with water. These are mixed together to make up the injection you take (solution for injection). 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. Take a tray out of the box. 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 BIO-SET (vial + base + cap)
- one syringe
- one injection needle (see picture ?Contents of the plastic tray?).
2. Wash your hands thoroughly with soap and water and dry them.
3. Prepare alcohol wipes and sticking plasters (not supplied) if you need them.
4. 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 Remove cap off the vial Twist, then pull cap off. Do not touch the connection port.
2 Pull the cap off the syringe Hold the base of the syringe. Pull the cap off. Do not touch the connection port. Do not push on the plunger.
3 Line up the syringe and vial Place the Bio-Set on a flat surface. Line up the two connection ports so that they are in a straight line. Hold the syringe by the base. Screw it firmly clockwise into the vial.
4 Push the syringe down until it clicks Keep the Bio-Set on the flat surface and hold the syringe by the base. Keep them in a straight line. Tip If the syringe is at an angle to the Bio-Set, it will leak. Push the syringe until it clicks.
5 Mix the water and powder Slowly inject all the water from the syringe into the vial. Tip Dont push the plunger quickly. This turns the solution to foam that cant be drawn into the syringe. Push the plunger right down to get air out of the syringe.
6 Dissolve the powder fully Pick up the vial and the syringe, keeping them attached and straight. Gently swirl the vial until all the powder has dissolved. Do not shake this will make froth.
7 Fill the syringe Turn the syringe and vial upside down, still in a straight line. Tip If the syringe is at an angle to the Bio-Set, it will leak. Slowly pull the plunger until all the liquid is in the syringe.
8 Separate syringe and vial Hold the filled syringe by the base. Turn it anti-clockwise to remove it from the Bio-Set vial. Do not touch the connection port on the syringe.
C: Giving the injection
1 Check the liquid in the syringe It should be clear and colourless. If the solution is any colour except colourless or slightly yellow, or if you can see particles floating in it, do not inject.
2 Fit the needle Unwrap the needle to expose the connection port. Keep the cover on. Push and twist the needle clockwise onto the syringe. 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.
3 Remove any air To remove air, point the syringe needle upwards. Gently tap to bring air bubbles to the top. Push the plunger carefully to remove the air. Dont let more than a small drop of liquid escape.
4 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.
5 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.
6 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, syringe and vial into a special container such as a sharps bin, not in ordinary rubbish. Waste paper and used wipes can be put in an ordinary rubbish bin.