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Cerezyme

Cerezyme Description

imiglucerase

Manufacturer:

sanofi-aventis
Full Prescribing Info
Description
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).
* 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/Inactive Ingredients: This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see Dosage & Administration). After reconstitution, the solution contains 1.24 mmol sodium (400 U/10 mL). To be taken into consideration by patients on a controlled sodium diet.
Mannitol, Trisodium Citrate, Disodium Hydrogen Citrate, Polysorbate 80. Citric Acid and/or Sodium Hydroxide may have been added at the time of manufacture to adjust pH.
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