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Myozyme 50 mg, powder for concentrate for solution for infusion
2015-10-17 13:49:54 来源: 作者: 【 】 浏览:568次 评论:0
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

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