Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
Interferon beta-1b, Quantity: 0.25 mg/mL
Bayer Australia Ltd
Injection, powder for
Excipient Ingredients: Albumin; mannitol
Subcutaneous
15 x 0.25mg powder for injection vials with 1.2mL diluent syringes
(S4) Prescription Only Medicine
Betaferon is indicated for the treatment of: - Ambulatory patients with relapsing-remitting multiple sclerosis (MS) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery. - Betaferon is also indicated for the reduction of frequency and severity of clinical relapses, and for the slowing of progression of disease in patients with secondary progressive multiple sclerosis. - The treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (MRI) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.
Visual Identification: WHITE TO OFF WHITE CAKE OR POWDER.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2002-08-09
BETAFERON ® Single Use Pack CMI vx1.0 1 BETAFERON (BEE·TA·FEER·ON) _interferon beta-1b (rbe)_ CONSUMER MEDICINE INFORMATION_ _ _ _ CONTENTS: What is in this leaflet ………. 1 What Betaferon is used for …. 1 Before you use Betaferon …... 2 How Betaferon is given/used ………………….. 3 While you are using Betaferon …………………... 7 Side effects ………………… 7 After Using Betaferon ……… 8 Product Description ………… 9 Further information ………… 9 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Betaferon. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Betaferon against the benefits it will have for you. If you have any concerns about taking this medicine, ask your doctor, nurse or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT BETAFERON IS USED FOR Betaferon belongs to a class of medicines known as interferons. Interferons are naturally occurring proteins, produced by the body that help fight against attacks on the immune system such as viral infections. The active substance of Betaferon is interferon beta-1b, a recombinant human interferon beta produced from a strain of _Escherichia coli_ . _HOW IT WORKS _ Multiple sclerosis (MS) is a long term condition that affects the central nervous system (CNS) i.e. brain and spinal cord. The exact cause of MS is unknown. An abnormal response by the body’s immune system is thought to play an important part in the process which damages the CNS. Betaferon has been shown to change the response of the immune system and to help reduce disease activity. Single clinical event indicating high risk of developing MS: Betaferon is for use in patients who for the first time have experienced symptoms which indicate a high risk for development of multiple sclerosis. Your doctor will rule out any other reasons which Διαβάστε το πλήρες έγγραφο
BETAFERON PI V3.0; CCDS V15 Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION BETAFERON ® (INTERFERON BETA-1B) POWDER FOR INJECTION VIAL WITH DILUENT SYRINGE 1 NAME OF THE MEDICINE BETAFERON is interferon beta-1b (rbe), 8 million IU (0.25 mg). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of the reconstituted solution for injection contains 8 million IU (0.25 mg) of interferon beta-1b. 1 mL of solution for injection contains 5.4 mg sodium chloride. Interferon beta-1b is a purified, sterile lyophilised protein that has 165 amino acids and an approximate molecular weight of 18,500 daltons. It is produced by recombinant DNA techniques from a strain of _ Escherichia coli_ that bears a genetically engineered plasmid containing a modified human interferon beta gene. Interferon beta-1b differs structurally from natural human interferon beta by the presence of serine instead of cysteine in position 17, lack of methionine in position 1 and absence of carbohydrate moieties. BETAFERON contains mannitol. For the full list of excipients, see LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM BETAFERON is presented as a sterile lyophilised white to off-white cake or powder. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS BETAFERON is indicated for • the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (MRI) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded, • the treatment of ambulatory patients with relapsing-remitting multiple sclerosis (MS) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery, • the reduction of frequency and severity of clinical relapses, and for the slowing of progression of disease in patients with secondary progressive multiple sclerosis. 4.2 D OSE AND METHOD OF ADMINISTRATION G ENERAL Treatment with interferon beta-1b should be initiated under the supervision of a physician experienced in the Διαβάστε το πλήρες έγγραφο