tudy, four subjects received transfusions, three due to adverse events and one due to pre-existing anemia. In the European study, one subject received transfusions to treat pre-existing anemia.
--------------------------------------------------------------------------------
3
Oral surgery is defined as extraction of fewer than three teeth, if the teeth are non-molars and have no bony involvement. Extraction of more than one impacted wisdom tooth is considered major surgery due to the expected difficulty of the surgery and the expected blood loss, particularly in subjects with type 2A or type 3 VWD. Extraction of more than two teeth is considered major surgery in all patients.
14.3Virus Transmission Studies
Clinical evidence of the absence of virus transmission in Humate-P was obtained in additional studies.
In one study, none of the eva luable subjects (31 of 67) who received Humate-P developed HBV infection or showed clinical signs of non-A, non-B (NANB) hepatitis infection.
In another study, 32 lots of Humate-P were administered to 26 subjects with hemophilia or VWD who had not previously received any blood products. No subject developed any signs of an infectious disease, and the 10 subjects not previously vaccinated remained seronegative for markers of infection with HBV, HAV, cytomegalovirus (CMV), Epstein-Barr virus, and HIV.
In a retrospective study, 155 subjects eva luated remained negative for the presence of HIV-1 antibodies for time periods ranging from 4 months to 9 years from the initial administration of Humate-P. All 67 of the subjects tested for HIV-2 antibodies remained seronegative.
15REFERENCES
Levine PH, Brettler DB. Clinical aspects and therapy for hemophilia A. In: Hoffman R, Benz JB, Shattil SJ, Furie B, Cohen HJ, eds. Hematology: Basic Principles and Practice. New York: Churchill Livingstone Inc.; 1991:1296-1297.
Scott JP, Montgomery RT. Therapy of von Willebrand disease. Semin Thromb Hemost. 1993;19:37-47.
Mannucci, PM. Venous Thromboembolism in Von Willebrand Disease. Thromb Haemostas. 2002;88:378-379.
Markis M, Colvin B, Gupta V, Shields ML, Smith MP. Venous thrombosis following the use of intermediate purity FVIII concentrate to treat patients with von Willebrand's disease. Thromb Haemostas. 2002;88:387-388.
Berntorp E, Nilsson IM. Biochemical and in vivo properties of commercial virus-inactivated factor VIII concentrates. Eur J Haematol. 1988;40:205-214.
Berntorp E. Plasma product treatment in various types of von Willebrand's disease. Haemostasis. 1994;24:289-297.
Hoyer LW. The factor VIII complex: structure and function. Blood. 1981;58:1-13.
Meyer D, Girma J-P. von Willebrand factor: structure and function. Thromb Haemostas. 1993;70:99-104.
16HOW SUPPLIED/STORAGE AND HANDLING
Humate-P is supplied in a single-dose vial containing the labeled amount of VWF:RCo and FVIII activity expressed in International Units (IU). Each package contains a vial of Humate-P, a vial of diluent containing sterile water (meets USP chemistry requirements Sterile Water for Injection, except for pH), a Mix2Vial filter transfer set, and two alcohol swabs.
The components used in the packaging for Humate-P contain no latex.
Approximate potencies are shown below; check each carton/vial for the actual potency prior to reconstitution:
NDC Number VWF:RCo/vial FVIII/vial Diluent
IU = International Units.
63833-615-02 600 IU 250 IU 5 mL
63833-616-0 |
