Basic Information
KOATE-DVI FOR INJECTION 1000 iu/10 ml
INJECTION, POWDER, FOR SOLUTION
Regulatory Information
SIN11783P
January 24, 2002
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
June 3, 2025
XB02BD02
Company Information
GRIFOLS ASIA PACIFIC PTE. LTD.
GRIFOLS ASIA PACIFIC PTE. LTD.
Active Ingredients
Strength: min 800 iu/10 ml
Detailed Information
Contraindications
**CONTRAINDICATIONS** None known.
Indication Information
**INDICATIONS AND USAGE** Koāte-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. Koāte-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. Koāte-DVI contains naturally occurring von Willebrand factor, which is co-purified as part of the manufacturing process. Koāte-DVI has not been investigated for efficacy in the treatment of von Willebrand disease, and hence is not approved for such usage.