Abcertin

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Abcertin

  • 1. Description
  • Abcertin® (imiglucerase for injection) is an analogue of the human enzyme β-glucocerebrosidase, produced by recombinant DNA technology. β –glucocerebrosidase (β –D-glycosyl-N-acylsphingosine glucohydrolase) is a lysosomal glycoprotein enzyme which catalyzes the hydrolysis of the glycolipid glucocerebroside to glucose and caramide. The pathogenesis of Gaucher disease was identified as genetic mutations that caused deficiency of the enzyme activity of β –glucocerebrosidase, which is necessary in breakdown of the lipid glucocerebroside, for intracellular lipid metabolism of human body. The deficiency of the enzyme glucocerebrodidase leads to the accumulation of the lipid glucocerebroside within the lysosomes of macrophages. This accumulation again leads to symptoms like anemia, thrombocytopenia, hepatomegaly, splenomegaly, bone crisia and neurological manifestations.

    Abcertin® 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 212 Units of Imiglucerase, 170 mg of D- mannitol, 0.53 mg of Polysorgate 80, 70 mg of Sodium citrates (mixtures of trisodium citrates and disodium hydrogen citrate) and citriac acid/Sodium hydroxide.
  • 2. Indications and Usage
  • Abcertin® (imiglucerase for injection) is indicated for use as long-term enzyme replacement therpy in patients with a confirmed diagnosis of Type 1 Gaucher disease who show symptom in one or more of the following conditions:
    ㆍAnemia after exclusion of other causes, such as iron deficiency
    ㆍThrombocytopenia
    ㆍBone disease after exclusion of other causes, such as Vitamin D deficiency
    ㆍHepatomegaly or splenomegaly
  • 3. How Supplied
  • Abcertin® (Imiglucerase for injection) vial contains either 200U or 400U imiglucerase 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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