Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
ANTIHEMOPHILIC FACTOR HUMAN (UNII: 839MOZ74GK) (ANTIHEMOPHILIC FACTOR HUMAN - UNII:839MOZ74GK), VON WILLEBRAND FACTOR HUMAN (UNII: ZE22NE22F1) (VON WILLEBRAND FACTOR HUMAN - UNII:ZE22NE22F1)
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
ANTIHEMOPHILIC FACTOR HUMAN
ANTIHEMOPHILIC FACTOR HUMAN 100 [iU] in 1 mL
INTRAVENOUS
Wilate is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. Clinical trials to evaluate the safety and efficacy of prophylactic dosing with Wilate to prevent spontaneous bleeding have not been conducted in VWD subjects. Wilate is not indicated for the prevention of excessive bleeding during and after surgery in VWD patients. Wilate is not indicated for Hemophilia A. Wilate is contraindicated for patients who have known anaphylactic or severe systemic reaction to plasma-derived products, any ingredient in the formulation, or components of the container. For a complete listing of ingredients, see Description ( 11 ). Pregnancy Category C. Animal reproduction studies have not been conducted with Wilate. It is also not known whether
67467-182-01 67467-182-02 500 IU VWF:RCo and 500 IU FVIII activities in 5 mL 1000 IU VWF:RCo and 1000 IU FVIII activities in 10 mL ≤ 7.5 mg ≤ 15.0 mg Shelf life
Biologic Licensing Application
WILATE - VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN)- VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN) POWDER, FOR SOLUTION OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE WILATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR WILATE. WILATE, VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN), POWDER FOR SOLUTION, FOR INTRAVENOUS USE ONLY. INITIAL U.S. APPROVAL: 2009 INDICATIONS AND USAGE • Wilate is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. ( 1 ) •Wilate is not indicated for the prophylaxis of spontaneous bleeding episodes, or the prevention of excessive bleeding during and after surgery in VWD patients. •Wilate is not indicated for Hemophilia A • DOSAGE AND ADMINISTRATION •For Intravenous Use Only (2) • (2) TYPE OF HEMO RRHAG ES LOADING DOSAGE (IU VWF:RCO /KG BW) MAINTENANCE DOSAGE (IU VWF:RCO /KG BW) THERAPEUTIC GOAL Minor (2) 20-40 IU/kg (2) 20-30 IU/kg every 12-24 hours (2) VWF:RCo and FVIII activity through levels of >30% (2) Major (2) 40-60 IU/kg (2) 20-40 IU/kg every 12-24 hours (2) VWF:RCo and FVIII activity through levels of >50% (2) • (2) DOSAGE FORMS AND STRENGTHS • Wilate is a sterile, lyophilized powder for reconstitution for intravenous injection, provided in the following nominal strengths per vial ( 3 ): •500 IU VWF:RCo and 500 IU FVIII activities in 5 mL •1000 IU VWF:RCo and 1000 IU FVIII activities in 10 mL • CONTRAINDICATIONS • Hypersensitivity with known anaphylactic or severe systemic reaction to human plasma-derived products, any ingredient in the formulation, or components of the container. ( 4 ) • WAR Կարդացեք ամբողջական փաստաթուղթը