What Rebif contains
The active substance is interferon beta-1a. Each pre-filled pen contains 22 micrograms, corresponding to 6 million International Units (IU) of interferon beta-1a.
The other ingredients are mannitol, poloxamer 188, L-methionine, benzyl alcohol, sodium acetate, acetic acid, sodium hydroxide and water for injections.
What Rebif looks like and contents of the pack
Rebif is available as a solution for injection in a pre-filled pen for self-administration. Rebif solution is clear to opalescent. The pre-filled pen is ready for use and contains 0.5 ml of solution. Rebif is available in packs of 1, 3 and 12 pre-filled pens (RebiDose). Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Serono Europe Limited
56, Marsh Wall
London E14 9TP
Merck Serono S.p.A.
Via delle Magnolie 15
I-70026 Modugno (Bari)
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien MERCK NVSA Brusselsesteenweg 288 B-3090 Overijse TélTel 32-2-686 07 11 LuxembourgLuxemburg MERCK NVSA Brusselsesteenweg 288 B-3090 Overijse, BelgiqueBelgien TélTel 32-2-686 07 11
Magyarország Merck Kft. Bocskai út 134-146. H-1113 Budapest Tel 36-1-463-8100 . . 83 1582 Te 359 28075 111
eská republika Merck spol. s r.o. Na Hebenech II. 171810 CZ-140 00 Praha 4 Tel. 420 272084211 Malta Cherubino Ltd Delf Building Sliema Road MT-GZR 06 Gzira Malta Tel 356-21-3432701234
Danmark Merck AB Strandvejen 102 B, 4th DK-2900 Hellerup Tlf 45 35253550 Nederland Merck BV Tupolevlaan 41-61 NL-1119 NW Schiphol-Rijk Tel 31-20-6582800
Deutschland Merck Serono GmbH Alsfelder Straße 17 D-64289 Darmstadt Tel 49-6151-6285-0 Norge Merck Serono Norge Luhrtoppen 2 N-1470 Lørenskog Tlf 47 67 90 35 90
Eesti Merck Serono OÜ Tornimäe 7 - 132 EE-10145, Tallinn Tel 372 682 5882 Österreich Merck GesmbH. Zimbagasse 5 A-1147 Wien Tel 43 1 57600-0
Polska Merck Sp. z o.o. Al. Jerozolimskie 178 PL-02-486 Warszawa Tel. 48 22 53 59 700 Merck A.E. 41-45, GR-151 23 T 30-210-61 65 100
Portugal Merck, s.a. Rua Alfredo da Silva, 3-C P-1300-040 Lisboa Tel 351-21-361 35 00 España Merck S.L. María de Molina, 40 E-28006 Madrid Línea de Información 900 200 400 Tel 34-91-745 44 00
România MERCK d.o.o., Dunajska cesta 119 SI-1000 Lubliana, Slovenia Tel 386 1 560 3 800 France Merck Serono s.a.s. 37, rue Saint-Romain F-69379 Lyon cedex 08 Tél. 33-4-72 78 25 25 Numéro vert 0 800 888 024
Slovenija MERCK d.o.o. Dunajska cesta 119 SI-1000 Ljubljana Tel 386 1 560 3 800 Ireland Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX United Kingdom Tel 44-20 8818 7200
Ísland Icepharma hf Lynghálsi 13 IS-110 Reykjavík Tel 354 540 8000 Slovenská republika Merck spol. s r.o. Tuhovská 3 SK-831 06 Bratislava Tel 421 2 49 267 111
Italia Merck Serono S.p.A. Via Casilina 125 I-00176 Roma Tel 39-06-70 38 41 SuomiFinland Merck Oy Pihatörmä 1 C FIN-02240 Espoo PuhTel 358-9-8678 700
Sverige Merck AB S-195 87 Stockholm Tel 46-8-562 445 00 . . 35, CY-2234 , . 357 22490305
Latvija Merck Serono SIA Duntes iela 23A LV-1005, Rga Tel 371 67152500 United Kingdom Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX- UK Tel 44-20 8818 7200
Merck Serono UAB
Savanoriu pr. 192,
Tel: +370 37320603
This leaflet was last approved in
INSTRUCTIONS FOR HANDLING OF REBIF IN PRE-FILLED PEN (RebiDose)
This section contains information on how to properly use RebiDose. The first injection(s) must be performed under the supervision of an appropriately qualified healthcare professional. After receiving adequate training, you, a family member, friend or carer can use RebiDose to administer the medicine at home. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
How do you, or the person injecting you, use RebiDose
Your doctor has prescribed Rebif in the RebiDose for injection into the tissue just under the skin. Only use each RebiDose for one injection.
Read all the following instructions carefully before using RebiDose.
To give yourself an injection you will need:
- A new RebiDose and
- Alcohol wipes or similar.
Below is a diagram that shows what RebiDose looks like.
Before the injection After the injection
A. Cap B. Transparent control area C. Plunger D. Label E. Main body F. Button G. Safety guard H. Needle
What to do before you give yourself a subcutaneous injection with RebiDose
Wash your hands thoroughly with soap and water. Remove RebiDose from the blister pack by peeling back the plastic covering. Check the appearance of Rebif through the transparent control area. It must be clear to opalescent, without particles and without any visible signs of deterioration. If there are particles or other visible signs of deteriorations, do not use it and contact your doctor, nurse or pharmacist for assistance. Check the expiry date on the RebiDose label as indicated as EXP. You can also check the expiry date on the RebiDose outer box. Do not use RebiDose if the expiry date has passed.
Where to inject with RebiDose
Choose an injection site. Your doctor will advise you on the possible injection sites good sites include the upper thighs and the lower abdomen. It is recommended that you keep track of and rotate your injection sites, so that one area is not injected too frequently in order to minimise the risk of injection site necrosis. NOTE do not use any areas in which you feel lumps, firm knots, or pain talk to your doctor or healthcare professional about anything you find.
How to inject with RebiDose
Do not remove the cap until you are ready to administer the injection. Before the injection use an alcohol wipe to clean the skin at the injection site. Let the skin dry. If a bit of alcohol is left on the skin, you may get a stinging sensation.
Hold RebiDose by the main body and use your other hand to remove the cap. Hold RebiDose at a right angle 90 degrees to the injection site. Push the pen down until you feel resistance. This action unlocks the button. Keep enough pressure on the skin and press the button with your thumb. You will hear a click which indicates the start of the injection and the plunger will start moving. Keep RebiDose pressed against the skin for at least 10 seconds in order to deliver the full medicinal product. It is not necessary to keep the button pressed down with your thumb after the injection has begun. Remove RebiDose from the injection site. The safety guard automatically surrounds the needle and locks into place to protect you from the needle.
Look through the transparent control area to make sure that the plunger has moved to the bottom as indicated in the figure. Visually check that there is no liquid left. If there is liquid left, not all of the medicinal product has been injected and you should consult your doctor or nurse for assistance.
Gently massage the injection site with a dry cotton ball or gauze.
In case of any difficulties while using RebiDose, please contact your doctor or nurse for assistance.
How to dispose of used RebiDose
RebiDose is for single use only and should never be reused. Never put the needle cap back on the used RebiDose. Once you have finished your injection, immediately discard RebiDose in an appropriate disposal unit. To avoid any injury, never insert your fingers in the opening of the safety guard covering the needle.