Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ALGLUCOSIDASE ALFA
AVENTIS PHARMA - Indonesia
ALGLUCOSIDASE ALFA
50 Mg
SERBUK INFUS
DUS, 1 VIAL @ 50 MG
GENZYME IRELAND LIMITED - Ireland
2020-10-29
Pharmacode 1. NAME OF THE MEDICINAL PRODUCT Myozyme 50 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 4.2 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 of 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 ( Baca dokumen lengkapnya