WILATE - VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN) (von willebrand factor/coagulation factor viii complex- h

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

ANTIHEMOPHILIC FACTOR HUMAN (UNII: 839MOZ74GK) (ANTIHEMOPHILIC FACTOR HUMAN - UNII:839MOZ74GK), VON WILLEBRAND FACTOR HUMAN (UNII: ZE22NE22F1) (VON WILLEBRAND FACTOR HUMAN - UNII:ZE22NE22F1)

Beszerezhető a:

Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.

INN (nemzetközi neve):

ANTIHEMOPHILIC FACTOR HUMAN

Összetétel:

ANTIHEMOPHILIC FACTOR HUMAN 100 [iU] in 1 mL

Az alkalmazás módja:

INTRAVENOUS

Terápiás javallatok:

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

Termék összefoglaló:

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

Engedélyezési státusz:

Biologic Licensing Application

Termékjellemzők

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