Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated, is a freeze-dried sterile human plasma fraction with Factor VIII inhibitor bypassing activity. In vitro, Feiba VH shortens the activated partial thrombop last in time (APTT) of plasma containing Factor VIII inhibitor. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One IMMUNO Unit of activity is defined as that amount of Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated which shortens the APTT of a high titer Factor VIII inhibitor reference plasma to 50% of the blank value. The product is intended for intravenous administration.

Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated contains Factors II,IX, and X, mainly non-activated, and Factor VII 1-3 mainly in the activated form. The product contains approximately equal unitages of Factor VIII inhibitor bypassing activity and Prothrombin Complex Factors. In addition,1-6 units of Factor VIII coagulant antigen (F VIII C :Ag) per mL are present. The preparation contains only traces of factors of the kin in generating system. It contains no heparin.

Reconstituted Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated contains 4 mg of trisodium citrate and 8 mg of sodium chloride per mL. Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated has been prepared from Source Plasma and/or Plasma.

The product has been subjected to in-process virus inactivation where vapor is first applied for 10 hours at 60° ± 0.5°C and an excess pressure of 190 ± 20 mbar followed by 1 hour at 80° ± 0.5°C and an excess pressure of 370 ± 30 mbar.(Refer to Clinical Pharmacology and Warnings sections.)

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