AVONEX Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
AVONEX 30 micrograms/0.5 ml solution for injection.
Qualitative and quantitative composition
Each 0.5 ml pre-filled syringe contains 30 micrograms (6 million IU) of interferon beta-1a. The concentration is 30 micrograms per 0.5 ml. Using the World Health Organisation (WHO) International Standard ...
Pharmaceutical form
Solution for injection. Clear and colourless solution.
Therapeutic indications
AVONEX is indicated for the treatment of: Patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous ...
Posology and method of administration
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. Posology Adults The recommended dosage for the treatment of relapsing MS is 30 micrograms (0.5 ...
Contraindications
Patients with a history of hypersensitivity to natural or recombinant interferon beta or to any excipients listed in section 6.1. Patients with current severe depression and/or suicidal ideation (see sections ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. AVONEX should be administered with ...
Interaction with other medicinal products and other forms of interaction
No formal interaction studies have been performed in humans. The interaction of AVONEX with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically. The clinical studies ...
Fertility, pregnancy and lactation
Pregnancy A large amount of data (more than 1000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure ...
Effects on ability to drive and use machines
No studies on the effects of AVONEX on the ability to drive and use machines have been performed. Central nervous system-related adverse reactions may have a minor influence on the ability to drive and ...
Undesirable effects
The highest incidence of adverse reactions associated with AVONEX therapy is related to flu-like symptoms. The most commonly reported flu-like symptoms are myalgia, fever, chills, sweating, asthenia, headache ...
Overdose
No case of overdose has been reported. However, in case of overdose, patients should be hospitalised for observation and appropriate supportive treatment given.
Pharmacodynamic properties
Pharmacotherapeutic Group: Interferons ATC code: L03AB07 Interferons are a family of naturally occurring proteins that are produced by eukaryotic cells in response to viral infection and other biological ...
Pharmacokinetic properties
The pharmacokinetic profile of AVONEX has been investigated indirectly with an assay that measures interferon antiviral activity. This assay is limited in that it is sensitive for interferon but lacks ...
Preclinical safety data
Carcinogenesis No carcinogenicity data for interferon beta-1a are available in animals or humans. Chronic Toxicity In a 26-week repeated dose toxicity study in rhesus monkeys by intramuscular route once ...
List of excipients
Sodium acetate trihydrate Acetic acid, glacial Arginine hydrochloride Polysorbate 20 Water for injections
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). DO NOT FREEZE. AVONEX can be stored at room temperature (between 15°C and 30°C) for up to one week. Store in the original package (sealed plastic tray) in order to protect ...
Nature and contents of container
1 ml pre-filled syringe made of glass (Type I) with a tamper evident cap and plunger stopper (bromobutyl) containing 0.5 ml of solution. Pack size: box of four or twelve pre-filled syringes of 0.5 ml. ...
Special precautions for disposal and other handling
AVONEX is provided as ready to use solution for injection in a pre-filled syringe. Once removed from the refrigerator, AVONEX in a pre-filled syringe should be allowed to warm to room temperature (15°C-30°C) ...
Marketing authorization holder
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP, Badhoevedorp, The Netherlands
Marketing authorization number(s)
EU/1/97/033/003 EU/1/97/033/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 March 1997 Date of latest renewal: 13 March 2007
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