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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 1 of 11 product information cerezyme® name of the medicine non-proprietary name
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