Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
interferon beta-1a
Biogen Netherlands B.V.
L03AB07
interferon beta-1a
Immunostimulants,
Multiple Sclerosis
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 three years without evidence of continuous progression between relapses; Avonex slows the progression of disability and decreases the frequency of relapses;patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite MS.Avonex should be discontinued in patients who develop progressive MS.
Revision: 37
Authorised
1997-03-13
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION AVONEX 30 micrograms/0.5 ml solution for injection Interferon beta-1a IM 2. METHOD OF ADMINISTRATION See package leaflet. 3. EXPIRY DATE EXP 4. BATCH NUMBER Lot 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 ml 6. OTHER 37 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1. NAME OF THE MEDICINAL PRODUCT AVONEX 30 micrograms/0.5ml solution for injection in pre-filled pen Interferon beta-1a 2. STATEMENT OF ACTIVE SUBSTANCE (S) Each pre - filled pen of 0.5 ml contains 30 micrograms (6 million IU) of interferon beta - 1a. 3. LIST OF EXCIPIENTS Sodium acetate trihydrate, acetic acid glacial, arginine hydrochloride, polysorbate 20, water for injections. 4. PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen 4 pre-filled pens. Each single pack contains 1 Avonex pen, injection needle and pen cover. 12 pre-filled pens. Each single pack contains 1 Avonex pen, injection needle and pen cover. 5. METHOD AND ROUTE (S) OF ADMINISTRATION Intramuscular use. Read the package leaflet before use. For single use only. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING (S), IF NECESSARY 38 8. EXPIRY DATE EXP 9. SPECIAL STORAGE CONDITIONS Store in a refrigerator. Do not freeze. The Avonex pen can be stored at room temperature (between 15°C - 30°C) for up to one week. Sensitivity to light. Store the Avonex pen in the original package to protect from light. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Biogen Netherlands B.V. Prins Mauritslaan 13 1171 LP Badhoevedorp The Netherlands 12. MARKETING AUTHORISATION NUMBER (S) EU/1/97/033/005 4 pack EU/1/97/033/006 12 pack 13. BATCH NUMBER Lot 14. GENERAL CLASSIFIC Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT AVONEX 30 micrograms/0.5 ml solution for injection. 2. 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 for Interferon, 30 micrograms of AVONEX contain 6 million IU of antiviral activity. The activity against other standards is not known. Excipient(s) with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AVONEX is indicated in adults 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 three-years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses. • Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1). AVONEX should be discontinued in patients who develop progressive MS. 4.2 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 ml solution), administered by intramuscular (IM) injection once a week (see section 6.6). No additional benefit has been shown by administering a higher dose (60 micrograms) once a week. _Titration: _To help patients reduce the incidence and severity of flu-like symptoms (see section 4.8), titration ca Прочетете целия документ