Myozyme 50 mg powder for concentrate for solution for infusion.
Powder for concentrate for solution for infusion.
White to off-white powder.
One vial contains 50 mg of alglucosidase alfa.
After reconstitution, the solution contains 5 mg of alglucosidase alfa* per ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
*Human acid α-glucosidase is produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology.
For a full list of excipients, see section 6.1.
Mannitol
Sodium dihydrogen phosphate monohydrate
Disodium phosphate heptahydrate
Polysorbate 80
50 mg of powder in a vial (Type 1 glass) with a stopper (siliconised butyl) and a seal (aluminium) with a flip-off cap (plastic). Pack sizes of 1, 10 or 25 vials.
Not all pack sizes may be marketed.
Genzyme Europe B.V.
Gooimeer 10
NL-1411 DD Naarden
The Netherlands
EU/1/06/333/001-003
Date of first authorisation: 29 March 2006
Date of latest renewal: 29 March 2011