ABCERTIN(Imiglucerase) Injection 200/UI started development from 2003 and received marketing authorization from KFDA in October 2012, began selling in the Korean market from January 2013. ABCERTIN Inj. is designated as an orphan drug for long term enzyme replacement therapy for Gaucher's Disease reaching global market size of 1.2 trillion KRW.
Overview and Features
Gaucher's Disease is caused by a hereditary mutation in the beta-glucocerebrosidase enzyme resulting in dysfunctional metabolism of fatty substance which accumulates in spleen, liver or bone marrow causing enlargement of liver and spleen or lowers bone density leading to death without proper treatment. ABCERTIN(Imiglucerase) INJ. 200UI uses gene recombination technology to produce recombinant human beta-glucocerebrosidase(INN: Imiglucerase) to replace the deficient enzyme through external administration allowing normalization of the fatty substance metabolism.
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Ingredient(API): 1 vial containing Imiglucerase 212 unit
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Apprearance: Vial containing white or grayish white lypholizated substance
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Indication: One or more symptoms from below/ As a long term ERT diagnosed with Gaucher's disease
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Amnesia (Not by Iron Deficiency)
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Reduced platelet
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Bone disease (not by Vitamin D deficiency)
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Hepatomegaly or splenomegaly
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Dosage and Usage: Intravenous injection for 1-2 hours. Dosage and Usage is determined to the patients accordingly. Initial dosage is 2.5U/kg, 3 times per week to 60U/Kg once in every 2 weeks. Normal dosage used is 60U/kg every two weeks.
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NHI Code: 668500060