国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Interferon beta-1b 0.25mg (20% excess in quantity filled)
Bayer New Zealand Limited
Interferon beta-1b 0.25 mg (20% excess in quantity filled)
8 MIU
Injection with diluent
Active: Interferon beta-1b 0.25mg (20% excess in quantity filled) Excipient: Albumin Hydrochloric acid Mannitol Sodium hydroxide Hydrochloric acid Sodium chloride Water for injection
Combination pack, 1 (pwdr+diluent syringe+adapter+needle+wipes), 1 dose unit
Prescription
Prescription
Boehringer Ingelheim RCV GmbH & Co KG
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 characterised by at least two attacks of neurological dysfunction over a two year period followed by complete or incomplete recovery. · the reduction of frequency and severity of clinical relapses and for slowing the progression of disease in patients with secondary progressive multiple sclerosis
Package - Contents - Shelf Life: Combination pack, 1 (pwdr+diluent syringe+adapter+needle+wipes) - 1 dose units - 24 months from date of manufacture stored at or below 30°C 3 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 15 (pwdr+diluent vial/syringe) - 15 dose units - 24 months from date of manufacture stored at or below 30°C 3 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, diluent - 1.2 mL - 36 months from date of manufacture stored at or below 30°C - Vial, powder - 0.3 mg - 24 months from date of manufacture stored at or below 30°C 3 hours reconstituted stored at or below 30°C - Vial, diluent - 1.2 mL - 36 months from date of manufacture stored at or below 25°C
1995-01-30
BETAFERON ® Single Use Pack CMI vx2.0 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 阅读完整的文件
BETAFERON DS VX3.0; CCDS V16 Page 1 of 2 NEW ZEALAND DATA SHEET 1 PRODUCT NAME BETAFERON® Interferon beta-1b 8 MIU Injection with diluent 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lyophilisate and solvent for solution for injection. BETAFERON® Recombinant Interferon beta-1b 0.25 mg (8.0 million IU) per mL when reconstituted. 1 mL of the reconstituted solution for injection contains 8 million IU (0.25 mg) of interferon beta-1b. 1 mL solution for injection contains 5.4 mg sodium chloride. Interferon beta-1b is produced in Escherichia coli cells by recombinant DNA technology from a strain of _Escherichia coli_ that bears a genetically engineered plasmid containing a modified human interferon beta gene. BETAFERON contains mannitol. For the full list of Excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM BETAFERON is presented as a sterile lyophilised white to off-white cake or powder and solvent for solution for injection. 4 CLINICAL PARTICULARS 4.1 Therapeutic 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 neurological dysfunction over a two year period followed by complete or incomplete recovery. • the reduction of frequency and severity of clinical relapses and for slowing the progression of disease in patients with secondary progressive multiple sclerosis 4.2 Dose and method of administration General Treatment with BETAFERON should be initiated under the supervision of a physician experienced in the treatment of multiple sclerosis. There are follow-up data under controlled clinical trial conditions for patients with relapsing–remitting multiple sclerosis for up to 5 years and for patients with secondary progressive mult 阅读完整的文件