ADVATE POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ANTIHEMOPHILIC FACTOR (RECOMBINANT)

Dostępny od:

TAKEDA CANADA INC

Kod ATC:

B02BD02

INN (International Nazwa):

COAGULATION FACTOR VIII

Dawkowanie:

1000UNIT

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000UNIT

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

2ML

Typ recepty:

Schedule D

Dziedzina terapeutyczna:

HEMOSTATICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0124180002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2021-05-27

Charakterystyka produktu

_ _
_ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free
Method] _
_Page 1 of 57_
PRODUCT MONOGRAPH
ADVATE
ANTIHEMOPHILIC FACTOR (RECOMBINANT),
PLASMA/ALBUMIN FREE METHOD (RAHF-PFM)
250, 500, 1000, 1500, 2000 AND 3000 INTERNATIONAL UNITS (IU) PER VIAL
COAGULANT
MANUFACTURED BY:
Baxalta US Inc.
Westlake Village, CA 91362
USA
IMPORTED AND DISTRIBUTED BY:
Baxalta Canada Corporation
7125 Mississauga Rd
Mississauga, ON L5N 0C2
SUBMISSION CONTROL NO.: 182614
APPROVAL DATE: APRIL 21, 2014
_ _
_ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free
Method] _
_Page 2 of 57_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
.......................................................