KOGENATE FS POWDER FOR SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ANTIHEMOPHILIC FACTOR (RECOMBINANT)

Saadav alates:

BAYER INC

ATC kood:

B02BD02

INN (Rahvusvaheline Nimetus):

COAGULATION FACTOR VIII

Annus:

500UNIT

Ravimvorm:

POWDER FOR SOLUTION

Koostis:

ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500UNIT

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

2.5ML

Retsepti tüüp:

Schedule D

Terapeutiline ala:

HEMOSTATICS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2015-08-13

Toote omadused

_ _
_KOGENATE FS Product Monograph_
_Page 1 of 32 _
PRODUCT MONOGRAPH
KOGENATE
® FS
Antihemophilic Factor (Recombinant)
_Formulated with Sucrose _
SUPPLIED WITH BIO-SET
Needle-less Reconstitution Set
IV Injection, 250, 500, 1000, 2000, 3000 IU/vial
Coagulation Factor
Bayer Inc.
77 Belfield Road
Toronto, Ontario
M9W 1G6
Canada
www.bayer.ca
Date of Revision:
November 15, 2013
SUBMISSION CONTROL NO: 159265 DATE OF APPROVAL: MAY 30, 2014
2013, Bayer Inc.
® KOGENATE, Bayer, and Bayer Cross are registered trademarks of Bayer
AG, used under
license by Bayer Inc.
_ _
_KOGENATE FS Product Monograph_
_Page 2 of 32 _
TABLE OF CONTENTS
PART
I:
HEALTH
PROFESSIONAL
INFORMATION ..........................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
DESCRIPTION
...........................................................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
...........................................................................................................
8
DRUG INTERACTIONS
...........................................................................................................
9
DOSAGE AND ADMINISTRATION
.....................................................................................
10
OVERDOSAGE
........................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
........................................................................