ADVATE POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ANTIHEMOPHILIC FACTOR (RECOMBINANT)

Dostępny od:

BAXTER HEALTHCARE CORPORATION

Kod ATC:

B02BD02

INN (International Nazwa):

COAGULATION FACTOR VIII

Dawkowanie:

500UNIT

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500UNIT

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

5ML VIAL

Typ recepty:

Schedule D

Dziedzina terapeutyczna:

HEMOSTATICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0124180003; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2013-10-08

Charakterystyka produktu

_ _
_ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free
Method] _
_Page 1 of 58_
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:
BAXTER HEALTHCARE CORPORATION
WESTLAKE VILLAGE, CA 91362
USA
IMPORTED AND DISTRIBUTED BY:
BAXTER CORPORATION
MISSISSAUGA, ON
CANADA L5N 0C2
DATE OF PREPARATION:
JULY 27, 2006
SUBMISSION CONTROL NO.: 158334
APPROVAL DATE: DECEMBER 6, 2012
_ _
_ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free
Method] _
_Page 2 of 58_
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
....................................................