Myozyme 50 mg powder for concentrate for solution for infusion
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 the full list of excipients, see section 6.1.
Powder for concentrate for solution for infusion.
White to off-white powder.
Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid α-glucosidase deficiency).
Myozyme is indicated in adults and paediatric patients of all ages.
Myozyme treatment should be supervised by a physician experienced in the management of patients with Pompe disease or other inherited metabolic or neuromuscular diseases.
Posology
The recommended dose regimen of alglucosidase alfa is 20 mg/kg of body weight administered once every 2 weeks.
Patient response to treatment should be routinely eva luated based on a comprehensive eva luation of all clinical manifestations of the disease.
Paediatric and older people
There is no evidence for special considerations when Myozyme is administered to paediatric patients of all ages or older people.
