Return to previous page|
Virus-inactivated fresh, frozen plasma
Batch release of Virus-inactivated fresh, frozen plasma. This product consists of pooled normal human plasma which has undergone a virus inactivation procedure (solvent/detergent treatment). It is used for replacement therapy in coagulation factor deficiencies caused by hepatic failure or when specific coagulation factor concentrates are not available. It is also used for the rapid reversal of the effects of oral anticoagulants and in the treatment of thrombotic thrombocytopoenic purpura.
Tests
Batch release of this product uses the following NIBSC reference materials:
Factor VIII Concentrates
Batch release of factor VIII therapeutic concentrates. These products consist of freeze-dried plasma-derived factor VIII purified from large pools of plasma from paid or volunteer donors. These plasma-derived factor VIII concentrates have undergone viral inactivation steps. They are used primarily for replacement therapy in the treatment Haemophilia A patients. They are also used in Immune Tolerance Induction (ITI) regimens to treat patients that develop antibodies or “Inhibitors” (alloantibodies or autoantibodies) to the FVIII molecule.
Batch release of these products uses the following NIBSC reference materials:
Activated prothrombin complex concentrate
Batch release of FEIBA (Factor Eight Inhibitor Bypassing Activity) concentrates. FEIBA is a plasma-derived activated prothrombin complex concentrate (APCC) and is used to control spontaneous bleeding episodes or cover surgical interventions in Haemophilia A & B patients who develop inhibitory antibodies (inhibitors) against factor VIII (FVIII) and factor IX (FIX), respectively.
Factor IX Concentrates
Two different types of factor IX concentrates are batch released: monocomponent factor IX and Prothrombin Complex Concentrates which consist of factor IX as well as factors II and X. These products consist of freeze-dried plasma-derived materials purified from large pools of plasma from paid or volunteer donors. These plasma-derived factor IX concentrates have undergone viral inactivation steps. They are used primarily for replacement therapy in the treatment Haemophilia B patients. Prothrombin Complex concentrates are also used in the reversal of the action of warfarin, an oral anticoagulant.
Antithrombin Concentrates
Antithrombin concentrates are used in replacement therapy for congenital and acquired antithrombin deficient patients. These products consist of freeze-dried plasma-derived materials purified from large pools of plasma from paid or volunteer donors. Antithrombin concentrates have undergone viral inactivation steps.
Additional Information:
The NIBSC has a staff member on the European Pharmacopoeia Group of Experts 6B (Human Blood and Blood products). This Group has the responsibility for the drafting and revision of all monographs relating to plasma-derived and recombinant therapeutics in this area (Coagulation factor concentrates, Immunoglobulins, Albumin).