HUMATE-P (antihemophilic factor/von willebrand factor complex- human kit

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

CSL Behring GmbH

INN (আন্তর্জাতিক নাম):

HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX

রচনা:

HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX 80 [iU] in 1 mL

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

Table 14. How Supplied Each product presentation includes a package insert and the following components:

অনুমোদন অবস্থা:

Biologic Licensing Application

পণ্য বৈশিষ্ট্য

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