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)
GRIFOLS USA, LLC
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX 250 [iU] in 5 mL
INTRAVENOUS
ALPHANATE, (antihemophilic factor/von Willebrand factor complex [human]), is indicated for: - Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII (FVIII) deficiency due to hemophilia A. - Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery. ALPHANATE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components [see Adverse Reactions (6) ]. Pregnancy Category C. Animal reproduction studies have not been conducted with ALPHANATE. It is also not known whether ALPHANATE can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. ALPHANATE should be given to a pregnant woman only if clearly needed. No human o
How Supplied ALPHANATE is supplied in sterile, lyophilized form in a single dose vial with a vial of diluent (Sterile Water for Injection, USP) and a Mix2Vial filter transfer set. IU activity of FVIII and VWF:RCo are stated on the carton and label of each vial. ALPHANATE is available in the following potencies and color coded based upon assay on the carton and label as follows: Storage and Handling ALPHANATE is stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 °C (77 °F). Do not freeze.
Biologic Licensing Application
ALPHANATE- ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN) GRIFOLS USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALPHANATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALPHANATE. ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX [HUMAN]) LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION INITIAL U.S. APPROVAL: 1978 INDICATIONS AND USAGE ALPHANATE, (antihemophilic factor/von Willebrand factor complex [human]), is indicated for: (1) Control and prevention of bleeding in adult and pediatric patients with hemophilia A. Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery. DOSAGE AND ADMINISTRATION FOR INTRAVENOUS INJECTION AFTER RECONSTITUTION ONLY. ALPHANATE contains the labeled amount of factor VIII expressed in International Units (IU) FVIII/vial and von Willebrand Factor:Ristocetin Cofactor activity in IU VWF:RCo/vial (2). DOSE (2.1) _Treatment and Prevention of Bleeding Episodes and Excess Bleeding During and After Surgery in Patients_ _with Hemophilia A_ Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL). Dosing frequency determined by the type of bleeding episode and the recommendation of the treating physician. _Treatment and Prevention of Excess Bleeding During and After Surgery or Other Invasive Procedures in_ _Patients with von Willebrand Disease_ Adults: Pre-operative dose of 60 IU VWF:RCo/kg body weight; subsequent doses of 40-60 IU VWF:RCo/kg body weight. Pediatric: Pre-operative dose of 75 IU VWF:RCo/kg body weight; subsequent doses of 50-75 IU VWF:RCo/kg body weight. DOSAGE FORMS AND STRENGTHS ALPHANATE is available as a lyophilized powder for intravenous injection after reconstitution in single dose vials containing 250, 500, 1000, 150 Läs hela dokumentet