KOGENATE FS POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ANTIHEMOPHILIC FACTOR (RECOMBINANT)

Disponibil de la:

BAYER INC

Codul ATC:

B02BD02

INN (nume internaţional):

COAGULATION FACTOR VIII

Dozare:

250UNIT

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250UNIT

Calea de administrare:

INTRAVENOUS

Unități în pachet:

2.5ML

Tip de prescriptie medicala:

Schedule D

Zonă Terapeutică:

HEMOSTATICS

Rezumat produs:

Active ingredient group (AIG) number: 0124180001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2009-08-06

Caracteristicilor produsului

_ _
_KOGENATE FS Product Monograph_
_Page 1 of 28 _
PRODUCT MONOGRAPH
KOGENATE
® FS
Antihemophilic Factor (Recombinant)
_Formulated with Sucrose_
IV Injection, 250, 500, 1000, 2000 IU/vial
Coagulation Factor
Bayer Inc.
77 Belfield Road
Toronto, Ontario
M9W 1G6
Canada
www.bayer.ca
Date of Revision:
July 7, 2009
Submission Control No: 124448 Date of Approval: July 30, 2009
©
2009, 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 28 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................7
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND
ADMINISTRATION................................................................................9
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND
STABILITY..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION