• 1. Description
  • Fabagal® (agalsidase beta for injection) is a recombinant analogue of Human α–galactosidase A and is produced by recombinant DNA technology using Chinese Hamster Ovary (CHO) cell culture.

    Fabry disease is occurred by deficiency and lack of α –galactosidase A (hydrolase in lysosome) activity and rare inherited metabolic disorders of X-linked recessive inheritance. Deficiency of α –galactosidase A activity causes the abnormality of lipometabolism and make abnormal accumulation of GL-3 (glycotriaosylceramide) and related glycosphinolipids in the wall of vessel of cell or tissue. It makes narrow the pass of the wall of blood vessel and inhibit flow of blood and nutrition supply. This process is applied for all human blood vessel and damaged to the function of tissues and organ specially in case of blood vessel of skin, kidney, heart and nervous system.

    Fabagal® is a white to off white lyophilized cake in colorless and transparent vial. After reconstitution, it is colorless and clear liquid. for intravenous (IV) use. Each single use vial contains 37 mg of agalsidase beta, 222 mg of D- mannitol, 23.09 mg of Sodium dihydrogen phosphate, 39.52mg of Sodium hydrogen phosphate.
  • 2. Indications and Usage
  • Fabagal® (agalsidase beta for injection) is indicated for long term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry diseases (α -galctosidase A deficiency)
  • 3. How Supplied
  • Fabagal® (agalsidase injection) vial contains 35 mg agalsidase beta in a vial. Vials should be stored at 2 to 8 °C (36 to 46 °F). Do not freeze. Do not use beyond the expiration date. Discard any unused portion left in the vial.
  • 4. Product Description
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  • Here, all information provided in this website is not purposed for the commercial promotion but, just for helping the people’s educational information in the medicinal uses. The medical uses (including diagnosis, prognosis and treatment) for the patients should be consulted by the medical doctors and the information provided here is not prioritized for the medical consulting.