Krajina: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
Alglucosidase alfa
SANOFI-AVENTIS SINGAPORE PTE. LTD.
A16AB07
52.5 mg
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Alglucosidase alfa 50 mg/vial
INTRAVENOUS
Prescription Only
Genzyme Ireland Limited
ACTIVE
2008-08-28
1 MYOZYME (ALGLUCOSIDASE ALFA) FOR INTRAVENOUS INFUSION ONLY NAME OF THE MEDICINAL PRODUCT Myozyme 50 mg powder for concentrate for solution for infusion. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 50 mg of alglucosidase alfa. After reconsititution, 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 List of Excipients. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white powder. CLINICAL PARTICULARS 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. 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 _ 2 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 Prečítajte si celý dokument
1 SG/MYO/0520/CCDSV9 MYOZYME Alglucosidase alfa FOR INTRAVENOUS INFUSION ONLY NAME OF THE MEDICINAL PRODUCT Myozyme 50 mg powder for concentrate for solution for infusion. 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 _List of excipients_ . PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white powder. CLINICAL PARTICULARS 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. 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. 2 SG/MYO/0520/CCDSV9 _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 incre Prečítajte si celý dokument