nchospasm, shortness of breath dyspnoea, pancreatitis, see Take special care with Extavia, blood levels of a specific liver enzyme gamma GT and a reddish yellow pigment bilirubin, which is produced by your liver, may rise this will show up in blood tests,
◾hepatitis,
◾skin discoloration,
◾menstrual disorders,
◾chest pain,
◾malaise,
◾sweating,
◾loss of weight.
How should it be stored?
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the pack.
Do not store above 25°C. Do not freeze.
After preparing the solution you should use it immediately. However, if you are not able to do so, it will remain usable for a period of 3 hours, if kept at 2-8°C (in a refrigerator).
Do not use Extavia if you notice it contains particles or is discoloured.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Extavia contains
◾The active substance is interferon beta-1b. Each vial contains 300 microgram (9.6 million IU) interferon beta-1b per vial. After reconstitution, each millilitre contains 250 microgram (8 million IU) interferon beta-1b.
◾The other ingredients are
◾in the powder: mannitol and human albumin.
◾in the solvent: sodium chloride, water for injections.
What Extavia looks like and contents of the pack
Extavia is a powder and solvent for solution for injection.
The powder is white to off-white.
The Extavia powder is provided in a 3-millilitre vial.
The solvent for Extavia is provided in a 1.2 ml pre-filled syringe and contains 1.2 ml sodium chloride 5.4 mg/ml (0.54% (w/v)) solution for injection.
Extavia is available in pack sizes of:
◾5 vials of interferon beta-1b and 5 pre-filled syringes containing solvent.
◾14 vials of interferon beta-1b and 14 pre-filled syringes containing solvent.
◾15 vials of interferon beta-1b and 15 pre-filled syringes containing solvent.
◾3-month multipack containing 42 (3x14) vials of interferon beta-1b and 42 (3x14) pre-filled syringes containing solvent.
◾3-month multipack containing 45 (3x15) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom
Manufacturer
Novartis Pharmaceuticals UK, Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0
Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00
eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217
Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111
