DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Koate-DVI (Antihemophilic Factor) - Summary

 

-- advertisement --

KOATE-DVI SUMMARY

Antihemophilic Factor (Human), Koàte®-DVI, is a sterile, stable, purified, dried concentrate of human Antihemophilic Factor (AHF, factor VIII, AHG) which has been treated with tri-n-butyl phosphate (TNBP) and polysorbate 80 and heated in lyophilized form in the final container at 80°C for 72 hours. Koàte-DVI is intended for use in therapy of classical hemophilia (hemophilia A).

Koàte-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII. Koàte-DVI provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia.

Koàte-DVI contains naturally occurring von Willebrand's factor, which is co-purified as part of the manufacturing process.

Koàte-DVI has not been investigated for efficacy in the treatment of von Willebrand's disease, and hence is not approved for such usage.

KOATE-DVI NEWS HIGHLIGHTS

Published Studies Related to Koate-DVI (Antihemophilic Factor)

Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy--International Kogenate-FS Study Group. [2000.06]

more>>

Clinical Trials Related to Koate-DVI (Antihemophilic Factor)

Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A [Completed]

Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A [Terminated]

Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A [Active, not recruiting]

Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A [Completed]

Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980 [Completed]

more>>

Page last updated: 2006-01-31

-- advertisement -- The American Red Cross

We comply with
HONcode standard.
Verify here.
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2008