Drug Class Description
Other alimentary tract and metabolism products - Enzymes
Generic Name
Agalsidase alfa
Drug Description
1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa.Each vial of 1 ml of concentrate contains 1 mg of agalsidase alfa.Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa.Agalsidase alfa is the human protein ?-galactosidase A produced in a human cell line by genetic engineering technology.
Presentation
Concentrate for solution for infusion.A clear and colourless solution.
Indications
Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (?-galactosidase A deficiency).
Adult Dosage
Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases.
Replagal is administered at a dose of 0.2 mg/kg body weight every other week by intravenous infusion over 40 minutes. For preparation and administration instructions, see section 6.6.
Patients aged over 65 years
