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Dried factor VIII

Generic Name:

Dried factor VIII

Description:

Factor VIII (FVIII) is an essential blood clotting protein, also known as antihemophilic factor (AHF). In humans, factor VIII is encoded by his F8 gene. Defects in this gene lead to hemophilia A, a recessive X-linked coagulation disorder. 

Factor VIII is produced in hepatic sinusoidal cells throughout the body and in endothelial cells on the outside of the liver. The protein circulates in the bloodstream in an inactive form bound to another molecule called von Willebrand factor until an injury occurs and damages the blood vessel.

This product is purified Factor VIII produced by ion exchange chromatography. It contains the intact Factor VIII complex. H.FVIII: C and von Willebrand factor (vWF) and fibrinogen are below detection limits. It is virus safe due to double virus inactivation.

By solvent cleaning method and heat treatment.

Composition:

Each bottle contains:

 

In 10gm injection in 100ml

Dried factor VIII-Biovex.jpeg
Dried Factor VIII-Biovex.jpeg

Source: 

Human Plasma as Non reactive for HBsAg, HCV, HIV I and II antibodies and negative for HCV RNA by PCR.

Indication:

This product is indicated to be used in Haemophilia A for the prevention and control of haemorrhagic episodes.

Human coagulation Factor VIII is also indicated for acquired Factor VIII deficiency and can also be significant therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda units per mL.

Method of Administration:

Administered through an intravenous route.

Presentation:

The product pack is user-friendly and kit includes one 20 ml syringe, two needles, water for injection, syringe filter and spirit swab.

 

Contraindications:

In case of allergic reaction the administration of Dried factor VIII should be discontinued immediately.

Possible side effect:

Allergic reactions must be encountered from the use of Antihemophilic factor (Human) preparation. The protein in highest concentration this product is Human Albumin. 

Reactions associated  with albumin are extremely rare, although nausea, fever, chills or Urticaria have been reported.

Shelf Life:

18 months from the date of manufacture.

Storage:

Store at +2°C to +8°C. Do not freeze. Protect from light.

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