ALPHANATE (antihemophilic factor/von willebrand factor complex- human kit

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX (UNII: 5T6B772R4Q) (HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX - UNII:5T6B772R4Q)

Inapatikana kutoka:

GRIFOLS USA, LLC

INN (Jina la Kimataifa):

HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX

Tungo:

HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX 250 [iU] in 5 mL

Njia ya uendeshaji:

INTRAVENOUS

Matibabu dalili:

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

Bidhaa muhtasari:

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.

Idhini hali ya:

Biologic Licensing Application

Tabia za bidhaa

ALPHANATE- ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)
GRIFOLS USA, LLC
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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