Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
INTERFERON BETA 1A
MEDISON PHARMA LTD
L03AB07
SOLUTION FOR INJECTION
INTERFERON BETA 1A 30 MCG / 0.5 ML
I.M
Required
BIOGEN IDEC LTD, UK
INTERFERON BETA-1A
INTERFERON BETA-1A
Treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and to decrease the frequency of clinical exacerbations. Treatment of patients who have experienced a single demyelinating event with an active inflammatory process if it is severe enough to warrant treatment with intravenous corticosteroids if alternative diagnosis have been excluded, including the prescence of MRI abnormalities characteristic of MS and if they are determined to be at high risk of developing clinically definite multiple sclerosis. Safety and efficacy in patients with chronic progressive multiple sclerosis has not been evaluated.
2017-11-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a physician’s prescription only . AVONEX SOLUTION FOR INJECTION SOLUTION FOR INJECTION IN A PRE-FILLED PEN/PRE-FILLED SYRINGE COMPOSITION: Each 0.5 ml syringe/ pen contains interferon beta-1a 30 µg * See inactive ingredients in section 6 (“Additional information”) in this leaflet READ THIS PACKAGE INSERT IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This leaflet includes concise information about this medicine. If you have additional questions, please consult your doctor or pharmacist. This medicine was prescribed for the treatment of your ailment. Do not pass it to others as it may harm them even if they seem to have a similar disease. AVONEX SOLUTION FOR INJECTION is not intended for use in children and adolescents under the age of 16. 1. INTRODUCTION: The active ingredient in AVONEX SOLUTION FOR INJECTION is a protein called interferon beta 1a. Interferons are substances that are naturally produced by the human body to protect it from infections and diseases. The protein in AVONEX SOLUTION FOR INJECTION is made from the same ingredients as interferon beta-1a found in the human body. WHAT IS AVONEX SOLUTION FOR INJECTION USED FOR? AVONEX SOLUTION FOR INJECTION is used to treat symptoms of relapsing multiple sclerosis. AVONEX SOLUTION FOR INJECTION can help reduce the occurrence of relapses and slow down the disabling effects of the disease. This medicine works best when injected regularly at the same time, once a week. Do not stop treatment with AVONEX SOLUTION FOR INJECTION without first consulting your neurologist. THERAPEUTIC GROUP: interferons. 2. BEFORE YOU USE THIS MEDICINE: DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to interferon beta or to any of the other ingredients in AVONEX SOLUTION FOR INJECTION (SEE SECTION 6, ‘ADDITIONAL INFORMATION’) • You have severe depression or suicidal thoughts. SPECIAL WARNINGS CONCERNING USE OF THIS MEDICINE: CONSULT YOUR DOCT Lesen Sie das vollständige Dokument
1 1. NAME OF THE MEDICINAL PRODUCT AVONEX 30 micrograms/0.5 ml solution for injection. in pre-filled syringe/pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 ml single use pre-filled syringe/pen 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 contains 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 for the treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and to decrease the frequency of clinical exacerbations. Avonex is also indicated for the treatment of patients who have experienced a single demyelinating event with an active inflammatory process if it is severe enough to warrant treatment with intravenous corticosteroids if alternative diagnosis have been excluded, including the prescence of MRI abnormalities characteristic of MS and if they are determined to be at high risk of developing clinically definite multiple sclerosis. Safety and efficacy in patients with chronic progressive multiple sclerosis has not been evaluated. 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 2 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 can be performed at the initiation of treatment. Titration Lesen Sie das vollständige Dokument