Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX (UNII: 5T6B772R4Q) (HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX - UNII:5T6B772R4Q)
CSL Behring GmbH
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX 80 [iU] in 1 mL
HUMATE-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is indicated for treatment and prevention of bleeding in adults with hemophilia A (classical hemophilia). HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for: Controlled clinical trials to evaluate the safety and efficacy of prophylactic dosing with HUMATE-P to prevent spontaneous bleeding have not been conducted in VWD subjects [see Clinical Studies (14)]. HUMATE-P is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to antihemophilic factor or von Willebrand factor preparations. Animal reproduction studies have not been conducted with HUMATE-P. It is also not known whether HUMATE-P can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HUMATE-P should be given to a pregnant woman only if clearly needed. It is not known whether HUMATE-P can cause harm to the mother or the fetus when administered during labor and deli
Table 14. How Supplied Each product presentation includes a package insert and the following components:
Biologic Licensing Application
HUMATE-P- ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN) CSL BEHRING GMBH ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HUMATE-P SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HUMATE-P. HUMATE-P [ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)] LYOPHILIZED POWDER FOR RECONSTITUTION FOR INTRAVENOUS USE ONLY. INITIAL U.S. APPROVAL: 1986 INDICATIONS AND USAGE HUMATE-P is an Antihemophilic Factor/von Willebrand Factor (VWF) Complex (Human) indicated for: Hemophilia A – Treatment and prevention of bleeding in adults. (1.1) Von Willebrand disease (VWD) – in adults and pediatric patients in the (1) Treatment of spontaneous and trauma- induced bleeding episodes, and (2) Prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD as well as patients with mild to moderate VWD where the use of desmopressin is known or suspected to be inadequate. (1.2) HUMATE-P is not indicated for the prophylaxis of spontaneous bleeding episodes in VWD. DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE ONLY. HEMOPHILIA A One International Unit (IU) of factor VIII (FVIII) activity per kg body weight increases the circulating FVIII level by approximately 2.0 IU/dL. Individualize dosage based on the patient's weight, type and severity of hemorrhage, FVIII level, and presence of inhibitors. (2.1) VWD Treatment of bleeding episodes – 40-80 IU VWF:Ristocetin Cofactor (RCo) per kg body weight (BW) every 8-12 hours. (2.2) Prevention of excessive bleeding during and after surgery for all types of VWD. (2.3) TYPE OF SURGERY (SEE TABLE 3 FOR COMPLETE SURGICAL DOSING) CALCULATION OF LOADING DOSE INITIAL MAINTENANCE DOSE SHOULD BE HALF THE LOADING DOSE (SEE TABLE 4 FOR MONITORING RE C O M M E NDATIO NS). * † ‡ Major Surgery (2.3) Δ VWF:RCo × BW (kg) IVR = IU VWF:RCo required Minor/Oral Surgery (2.3) Δ VWF:RCo × BW (kg) IVR = IU VWF:RCo required Emergency Surgery (2.3) Administer a dose of 50-60 IU Läs hela dokumentet