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White to pale yellow lyophilised powder.
Each vial contains 100 mg of avalglucosidase alfa.
After reconstitution, each vial contains a total extractable volume of 10.0 ml at a concentration of 10 mg of avalglucosidase alfa* per ml.
*Avalglucosidase alfa is a human acid α-glucosidase produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology, which is subsequently conjugated with approximately 7 hexamannose structures (each containing two terminal mannose-6-phosphate (M6P) moieties) to oxidised sialic acid residues on the molecule, thereby increasing bis-M6P levels.
Excipients/Inactive Ingredients: Histidine, Histidine hydrochloride monohydrate, Glycine, Mannitol, Polysorbate 80.
