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FEIBA VH Anti-Inhibitor Coagulant Complex, Vapor Heated (AICC) is a freeze-dried sterile human plasma fraction with Factor VIII inhibitor bypassing activity. In vitro, FEIBA VH (AICC) shortens the activated partial thromboplastin 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 FEIBA VH (AICC) that 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.

FEIBA VH (AICC) 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 (FVIII C:Ag) per mL are present. The preparation contains only traces of factors of the kinin generating system. It contains no heparin.

Reconstituted FEIBA VH (AICC) contains 4 mg of trisodium citrate and 8 mg of sodium chloride per mL.

FEIBA VH (AICC), 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. (See CLINICAL PHARMACOLOGY and WARNINGS sections).

REFERENCES

1. Elsinger F.: Aktivierter Faktor VII in Prothrombinkomplex-Konzentraten. 23rd Annual Meeting of „Deutsche Arbeitsgemeinschaft für Blutgerinnungsforschung" (DAB), Heidelberg, 1979. F. K. Schattauer Verlag, Stuttgart-New York, 367, 1980.

2. Seligsohn U., Østerud B., Rapaport S. I.: Coupled Amidolytic Assay for Factor VII: Its Use With a Clotting Assay to Determine the Activity State of Factor VII. Blood 52: 978, 1978.

3. Seligsohn U., Kasper C. K., Østerud B., Rapaport S. I.: Activated Factor VII: Presence in Factor IX Concentrates and Persistence in the Circulation After Infusion. Blood 53: 828, 1979.

Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.