Myozyme® (Alglucosidase alfa) 50mg Powder for Solution for Infusion

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**Posology and method of administration** 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 body weight administered once every 2 weeks. Patient response to treatment should be routinely evaluated based on a comprehensive evaluation 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. _Patients with renal and hepatic impairment_ The safety and efficacy of Myozyme in patients with renal or hepatic impairment have not been evaluated and no specific dose regimen can be recommended for these patients. Method of administration Myozyme should be administered as an intravenous infusion. Infusions should be administered incrementally. It is recommended that the infusion begin at an initial rate of 1 mg/kg/h and be gradually increased by 2 mg/kg/h every 30 minutes if there are no signs of infusion associated reactions (IARs) until a maximum rate of 7 mg/kg/h is reached. IARs are described in section _Undesirable effects_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. For instructions on reconstitution and dilution of the medicinal product before administration, see section _Special precautions for disposal and other handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.