HELIXATE FS POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ANTIHEMOPHILIC FACTOR (RECOMBINANT)

Disponible depuis:

BAYER HEALTHCARE LLC

Code ATC:

B02BD02

DCI (Dénomination commune internationale):

COAGULATION FACTOR VIII

Dosage:

500UNIT

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500UNIT

Mode d'administration:

INTRAVENOUS

Unités en paquet:

2.5ML

Type d'ordonnance:

Schedule D

Domaine thérapeutique:

HEMOSTATICS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2018-04-05

Résumé des caractéristiques du produit

_ _
_HELIXATE FS Product Monograph_
_Page 1 of 31 _
PRODUCT MONOGRAPH
HELIXATE
® FS
Antihemophilic Factor (Recombinant)
_Formulated with Sucrose_
IV Injection, 250, 500, 1000, 2000, 3000 IU/vial
Coagulation Factor
Manufactured by:
Bayer HealthCare LLC
100 Bayer Boulevard, Whippany
New Jersey
07981, U.S.A.
Imported and distributed by:
CSL Behring Canada Inc.
55 Metcalfe St., Suite 1460
Ottawa, Ontario
K1P 6L5
Date of Revision: June 5, 2014
Submission Control No.:
2014, CSL Behring Canada, Inc.
® HELIXATE is a registered trademark of CSL Behring L.L.C.
CONTROL NO: 175403 DATE OF APPROVAL: JULY 04, 2014
_ _
_HELIXATE FS Product Monograph_
_Page 2 of 31 _
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
....................................................................................................9
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND STABILITY
..........................................................................................17
SPECIAL HANDLIN