factor VIII C화학적 특성, 용도, 생산
개요
Factor VIII, a recombinant DNA product, is useful for the management of bleeding
episodes in patients with hemophilia A. A major advantage is that the synthetic version
is free from HIV and hepatitis viruses. It should also prevent any shortages of this
clotting factor.
World Health Organization (WHO)
Factor VIII, a naturally occurring plasma protein fraction, is a vital
component of the normal blood clotting mechanism which is deficient in
haemophiliacs who require replacement therapy for both the treatment and
prevention of bleeding. Factor VIII is extracted from the pooled plasma of a large
number of donors and is presented as a concentrate. It has been recognized since
1984 that some viruses, and particularly the HIV (AIDS virus) could be transmitted
to haemophiliacs from such preparations. As a result many regulatory authorities
have issued new directives for the manufacture of blood products that avert this
danger, by requiring the introduction of specific antiviral treatment measures
during the manufacturing process. Manufacturers have withdrawn pre-existing
preparations.
일반 설명
Antihemophilic factor VIII (recombinant), Recombinate,Kogenate, Bioclate, Helixate, is a plasma protein that functionsin the normal blood-clotting cascade by increasing theVmax for the activation of clotting factor X by factor IXa inthe presence of calcium ions and negatively charged phospholipids.Factor VIII is used in the treatment of hemophiliaA.
Recombinant factor VIII is indicated for the treatment ofclassical hemophilia (hemophilia A) and for the preventionand treatment of hemorrhagic episodes and perioperativemanagement of patients with hemophilia A. The drug is alsoindicated for the treatment of hemophilia A in persons whopossess inhibitors to factor VIII.
Recombinant factor VIII is supplied in sterile, singledosevials. The product is stabilized with human albuminand lyophilized. The product must be stored at 2°C to 8°C,without freezing. In some instances, the powder may bestored at room temperature for up to 3 months without lossof biological activity. Shaking of the reconstituted productshould be avoided because of the presence of the albumin.The drug must be administered by IV bolus or drip infusionwithin 3 hours of reconstitution.
factor VIII 준비 용품 및 원자재
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