Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Imiglucerase 212 U (biological product from recombinant CHO cells)
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Imiglucerase 212 U (biological product from recombinant CHO cells)
40 U/mL
Powder for infusion
Active: Imiglucerase 212 U (biological product from recombinant CHO cells) Excipient: Citric acid monohydrate Mannitol Nitrogen Polysorbate 80 Sodium citrate dihydrate
Vial, glass, 1 x 400U, 10 mL
Prescription
Prescription
Genzyme Corporation
Package - Contents - Shelf Life: Vial, glass, 1 x 400U - 10 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1998-08-12
New Zealand Data Sheet Cerezyme - Imiglucerase 1 cere-ccdsv5-dsv4-12jun23 NEW ZEALAND DATA SHEET 1. CEREZYME POWDER FOR INFUSION CEREZYME® Powder for infusion, 40U/mL, 400U/vial 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 400 units* of imiglucerase**. After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per mL (400U/10 mL). *An Enzyme Unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl -D-glucopyranoside (pNP-Glc) per minute at 37 C. **Imiglucerase is a modified form of human acid -glucosidase and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture, with mannose modification for targeting macrophages. Excipients: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Cerezyme is a white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cerezyme (imiglucerase) is indicated for long-term enzyme replacement therapy for patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: a) anaemia; b) thrombocytopenia; c) bone disease; d) hepatomegaly or splenomegaly. New Zealand Data Sheet Cerezyme - Imiglucerase 2 cere-ccdsv5-dsv4-12jun23 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Dosage should be individualised for each patient. Initial dosages range from 2.5U/kg of body weight 3 times a week to 60U/kg once every two weeks. 60U/kg every 2 weeks is the dosage for which most data are available. Disease severity may dictate that treatment be initiated at a relatively high dose or relatively frequent administration. Dosage adjustments should be made on an individual basis, and may increase or decrea Прочитайте повний документ