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This powder for concentrate for solution for infusion is a white to off-white powder.
Each vial contains 400 units* of imiglucerase**.
After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per mL (400 U/10 mL). Each vial must be further diluted before use (see Special precautions for disposal and other handling under Cautions for Usage).
*An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β-D-glucopyranoside (pNP-Glc) per minute at 37°C.
**Imiglucerase is a modified form of human acid β-glucosidase and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture, with mannose modification for targeting macrophages.
Excipients with known effect: Each vial contains 41 mg of sodium.
Excipients/Inactive Ingredients: Mannitol, Sodium citrate (to adjust pH), Citric acid monohydrate (to adjust pH), Polysorbate 80.
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