Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Interferon beta-1a 60 µg/mL
Biogen NZ Biopharma Ltd
Interferon beta-1a 60 µg/mL
30 mcg/0.5mL
Solution for injection
Active: Interferon beta-1a 60 µg/mL Excipient: Arginine hydrochloride Glacial acetic acid Polysorbate 20 Sodium acetate trihydrate Water for injection
Syringe, glass, 0.5mL pre-filled syringes, 4 dose units
Prescription
Prescription
Biogen Inc
Indicated for the treatment of relapsing forms of multiple sclerosis (MS).
Package - Contents - Shelf Life: Syringe, glass, 0.5mL pre-filled syringes - 4 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. may include one week at or below 30°C
2002-11-26
avoNZcmi10522 1 AVONEX Interferon beta-1a CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AVONEX Solution for Injection (also known as ‘AVONEX Pre-filled Syringe’ or ‘AVONEX PEN’. It does not contain all the available information. It does not take the place of talking to your specialist, doctor or pharmacist. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.biogen.com.au. The updated leaflet may contain important information about AVONEX and its use that you should be aware of. All medicines have benefits and risks. Your doctor has weighed the benefits AVONEX is expected to have for you, against the risks of using it. IF YOU HAVE ANY QUESTIONS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST OR CONTACT THE MULTIPLE SCLEROSIS (MS) SOCIETY IN YOUR STATE. You can also telephone the MS ALLIANCE Helpline on 1800 286 639 in Australia or 0800 286 639 in New Zealand (NZ) for additional assistance on using AVONEX. KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN. WHAT AVONEX IS USED FOR AVONEX is used for the treatment of relapsing forms of Multiple Sclerosis (MS). AVONEX treatment has been shown to: • Slow the progression of disability • Reduce the number of relapses • Delay the onset of definite MS after an illness suggesting MS The cause of MS is not yet known. MS affects the brain and spinal cord. In MS, the body’s immune system reacts against its own myelin (the ‘insulation’ surrounding nerve fibres). In relapsing forms of MS, people have ‘exacerbations’ from time to time (e.g. blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function). They are followed by periods of recovery. Recovery may be complete or incomplete. If it is Izlasiet visu dokumentu
AVONEX Data Sheet September 2023 Page 1 of 16 NEW ZEALAND DATA SHEET 1. PRODUCT NAME AVONEX® interferon beta-1a (rch) Solution for Injection Pre-filled Syringe AVONEX® interferon beta-1a (rch) Solution for Injection Pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Interferon beta-1a is a 166 amino acid glycoprotein with a specific activity of approximately 200 million international units (IU) of antiviral activity per mg. It has a predicted molecular weight of approximately 22,500 Daltons and is produced by mammalian (Chinese Hamster Ovary) cells into which the human interferon beta gene has been introduced. The amino acid sequence of AVONEX is identical to that of natural human interferon beta. AVONEX is produced by recombinant DNA technology and is manufactured as a 30 microgram solution for injection. AVONEX is supplied as a sterile solution for injection containing interferon beta-1a for intramuscular injection. Each 0.5 mL AVONEX Solution for Injection pre-filled syringe contains 30 µg of interferon beta-1a with 6 million IU of antiviral activity. Each 0.5 mL AVONEX Solution for Injection pen contains 30 µg of interferon beta-1a with 6 million IU of antiviral activity. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM AVONEX Pre-filled Syringe is supplied in a single use pre-filled syringe, available in packs of 4 blister trays. Each blister tray contains one pre-filled syringe of AVONEX and one needle used for IM administration. AVONEX PEN is supplied as a single use pre-filled pen, available in packs of 4 individual cartons. Each individual carton contains one AVONEX pre-filled pen, one 16 mm, 25 gauge needle and an AVONEX PEN cover. Not all presentations are being distributed in New Zealand. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AVONEX (Interferon beta-1a) is indicated for the treatment of relapsing forms of multiple sclerosis (MS). AVONEX is also indicated in patients who have experienced a single demyelinating event and are at risk of developing clinically definit Izlasiet visu dokumentu