Antihemophilic factor human and Von willebrand factor human

WILATE is indicated in adult and pediatric patients with von Willebrand disease (VWD) for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Routine prophylaxis to reduce the frequency of bleeding episodes WILATE is indicated in adult and pediatric patients 12 years of age and older with hemophilia A for: On-demand treatment and control of bleeding episodes Routine prophylaxis to reduce the frequency of bleeding episodes WILATE is indicated in adult and pediatric patients with von Willebrand disease for: On-demand treatment and control of bleeding episodes. Perioperative management of bleeding. Routine prophylaxis to reduce the frequency of bleeding episodes. WILATE is indicated in adult and pediatric patients 12 years of age and older with hemophilia A for: On-demand treatment and control of bleeding episodes.

WILATE contains von Willebrand factor (VWF) and coagulation factor VIII (FVIII), constituents of normal plasma. VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium, it also serves as a stabilizing carrier protein for the procoagulant protein FVIII, an essential cofactor in activation of factor X leading to formation of thrombin and fibrin. Patients suffering from VWD have a deficiency or abnormality of VWF. This reduction in VWF plasma concentration results in correspondingly low FVIII activity and abnormal platelet function, thereby resulting in excessive bleeding. After administration, WILATE temporarily replaces missing VWF and FVIII that are needed for effective hemostasis. When infused into a patient with hemophilia A, FVIII binds to VWF in the patient´s circulation.

For Intravenous Use after Reconstitution For Intravenous Use Only Von Willebrand Disease Use the following formula to determine required dosage: Required IU = body weight (BW) in kg x desired VWF:RCo rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL) Adjust dosage depending on the severity of VWD, clinical condition and/or pharmacokinetic data. Additionally, for on-demand treatment, adjust dosage and duration based on location and extent of the bleeding.

WILATE is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation, or components of the container. Do not use in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reaction, to human plasma-derived products, any ingredient in the formulation, or components of the container

Anaphylaxis and severe hypersensitivity reactions are possible. Thromboembolic events may occur. Monitor plasma levels of FVIII activity. Neutralizing antibodies (inhibitors) to VWF and Factor VIII have occurred following administration of WILATE. Test for neutralizing antibodies if plasma VWF and/or Factor VIII level fail to increase as expected or if bleeding is not controlled after WILATE administration,. WILATE is made from human plasma and carries the risk of transmitting infectious agents.

The most common adverse reactions (≥ 1%) in clinical trials on VWD were hypersensitivity reactions, urticaria, chest discomfort, and dizziness. The most common adverse reaction (≥ 1%) in clinical trials in hemophilia A was pyrexia (fever).

Storage and Handing Store WILATE for up to 36 months at +2°C to +8°C (36°F to 46°F) in the original containers to protect from light from the date of manufacture. Within this period, WILATE may be stored for a period of up to 6 months at room temperature (maximum of +25°C or 77°F). The starting date of room temperature storage should be clearly recorded on the product carton. Once stored at room temperature, the product must not be returned to the refrigerator. The shelf-life then expires after the storage at room temperature, or the expiration date on the product vial, whichever is earliest. Do not freeze.