Transcription of PRODUCT INFORMATION - Medsafe
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PRODUCT INFORMATION - Medsafe
Data Sheet Cerezyme - Imiglucerase 1 cere-ccdsv4-dsv2-16jul20 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 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.
VERSION: CZM PI ANZ A1204-01 SUPERCEDES: CZM ANZ A1003-01 COMMERCIAL Page 2 of 11 complications are a common, and frequently the most debilitating and disabling, feature of Gaucher
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