- Approval Id
- 468da735ff35b316
- Drug Name
- MYOZYME® (ALGLUCOSIDASE ALFA) 50MG POWDER FOR SOLUTION FOR INFUSION
- Product Name
- MYOZYME® (ALGLUCOSIDASE ALFA) 50MG POWDER FOR SOLUTION FOR INFUSION
- Approval Number
- SIN13543P
- Approval Date
- 2008-08-28
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- <p><strong>Posology and method of administration</strong><br>
Myozyme treatment should be supervised by a physician experienced in the management of patients with Pompe disease or other inherited metabolic or neuromuscular diseases.<br>
<u>Posology</u><br>
The recommended dose regimen of alglucosidase alfa is 20 mg/kg body weight administered once every 2 weeks.<br>
Patient response to treatment should be routinely evaluated based on a comprehensive evaluation of all clinical manifestations of the disease.<br>
<em>Paediatric and older people</em><br>
There is no evidence for special considerations when Myozyme is administered to paediatric patients of all ages or older people.<br>
<em>Patients with renal and hepatic impairment</em><br>
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.</p>
<p><u>Method of administration</u><br>
Myozyme should be administered as an intravenous infusion.<br>
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 <em>Undesirable effects</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
For instructions on reconstitution and dilution of the medicinal product before administration, see section Special precautions for disposal and other handling – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid α-glucosidase deficiency).<br>
Myozyme is indicated in adults and paediatric patients of all ages.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
Life threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients, when rechallenge was unsuccessful (see sections Special warnings and precautions for use and Undesirable effects – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- A16AB07
- Atc Item Name
- alglucosidase alfa
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/sanofi-aventis-singapore-pte-ltd
