Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Elosulfase alfa 1 mg/mL;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Elosulfase alfa 1 mg/mL
1 mg/mL
Concentrate for injection
Active: Elosulfase alfa 1 mg/mL Excipient: Arginine hydrochloride Monobasic sodium phosphate monohydrate Polysorbate 20 Sodium acetate trihydrate Sorbitol Water for injection
Prescription
BioMarin Pharmaceutical Inc
Treatment of mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) in children and adults of all ages.
Package - Contents - Shelf Life: Vial, glass, - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2015-02-19
VIMIZIM ® 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION VIMIZIM ® _elosulfase alfa (rch) _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Vimizim. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of treating you with Vimizim against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, TALK TO YOUR DOCTOR, NURSE OR THE HOSPITAL PHARMACIST. KEEP THIS LEAFLET WHILE YOU ARE BEING TREATED WITH VIMIZIM. You may need to read it again. WHAT VIMIZIM IS USED FOR Vimizim is used to treat children and adults of all ages with MPS IVA (Mucopolysaccharidosis Type IVA, Morquio A Syndrome). People with MPS IVA have either a low level, or reduced activity, of an enzyme called N-acetylgalactosamine-6-sulfatase (or GALNS), which breaks down specific substances (for example, keratan sulfate) in the body. As a result, these specific substances do not get broken down and processed by the body as they should. They accumulate in many tissues in the body, which causes the symptoms of MPS IVA. _HOW VIMIZIM WORKS _ This medicine contains an enzyme called elosulfase alfa. Elosulfase alfa is a recombinant version of a human enzyme produced by genetic engineering in Chinese Hamster Ovary (CHO) cells. It works by replacing the natural enzyme in MPS IVA patients. Treatment with VIMIZIM has shown improvement in walking ability and reduction of the levels of keratan sulfate . ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY VIMIZIM HAS BEEN PRESCRIBED FOR YOU. Vimizim is available only with a doctor's prescription. _USE IN CHILDREN _ Vimizim is recommended for use in children and adults. BEFORE STARTING TREATMENT WITH VIMIZIM _WHEN YOU MUST NOT HAVE IT _ DO NOT HAVE VIMIZIM IF YOU EXPERIENCE SEVERE OR LIFE- THREATENING ALLERGIC REACTIONS TO ELOSULFASE ALFA OR ANY OF THE OTHER INGREDIENTS OF VIMIZIM AND YOUR DOCTOR IS NOT ABLE TO CONTROL THESE RE Belgenin tamamını okuyun
Data Sheet - New Zealand V4 Supersedes: V3 (14 August 2017) Page 1 of 14 NEW ZEALAND DATA SHEET 1. VIMIZIM 1 MG/ML CONCENTRATED SOLUTION FOR INJECTION VIMIZIM ® elosulfase alfa (rch) 1 mg/mL concentrated solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 1 mg elosulfase alfa. *Each vial of approximately 5 mL extractable solution contains 5 mg elosulfase alfa. *Elosulfase alfa is a purified human enzyme produced by recombinant DNA technology in a Chinese hamster ovary cell line. Human N-acetylgalactosamine-6-sulfatase (EC 3.1.6.4) is a lysosomal enzyme that hydrolyses sulfate from either galactose-6-sulfate or N-acetyl-galactosamine-6-sulfate on the non-reducing ends of the glycosaminoglycans keratan sulfate (KS) and chondroitin sulfate. Elosulfase alfa is a soluble dimeric protein, and each monomer contains 496 amino acids with an approximate molecular mass of 55 kDa for the peptide chain. The oligosaccharides present at the two consensus N-linked glycosylation sites contain mannose-6-phosphate (M6P). M6P is recognised by a receptor at the cell surface and is crucial for efficient cellular uptake of the protein to the lysosome. Elosulfase alfa has a specific activity of 2.5 to 6.0 units/mg. One activity unit is defined as the amount of the enzyme required to convert 1 micromole of sulfated monosaccharide substrate D- galactopyranoside-6-sulfate (Gal-6S) to de-sulfated-galactose (Gal) and free sulfate per minute at 37°C. Excipient(s) with known effect Each 5 mL vial also contains 8 mg sodium and 100 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrated solution for injection. A sterile, nonpyrogenic, colourless to pale yellow and clear to slightly opalescent solution with a pH between 5.0 to 5.8 that must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection prior to administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vimizim is indicated for the treatment of mucopolysaccharidosis type IVA ( Belgenin tamamını okuyun