RECOMBIVAX HB (WITH PRESERVATIVE) SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HEPATITIS B SURFACE ANTIGEN (RECOMBINANT)

Available from:

MERCK CANADA INC

ATC code:

J07BC01

INN (International Name):

HEPATITIS B, PURIFIED ANTIGEN

Dosage:

10MCG

Pharmaceutical form:

SOLUTION

Composition:

HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10MCG

Administration route:

INTRAMUSCULAR

Units in package:

3ML/10X3ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0119570001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-03-08

Summary of Product characteristics

_ Product Monograph – RECOMBIVAX HB_
_®_
_ _
_Page 1 of 25_
PRODUCT MONOGRAPH
RECOMBIVAX HB
®
(hepatitis B vaccine [recombinant])
Suspension for Injection
Vaccine for immunization against infection
caused by hepatitis B virus including
all known subtypes
MERCK FROSST CANADA LTD.
16711 Trans Canada Highway
Kirkland QC H9H 3L1
Canada
www.merckfrosst.com
Date of Revision:
GLOBAL TRADE IDENTIFICATION NO.:
Pediatric: 0 67055 04523 3 (1 x 0.5 mL)
Adult: 0 67055 04569 1 (1 x 1 mL); 0 67055 04633 9 (10 x 1 mL)
Adult: 0 67055 03811 2 (1 x 3 mL); 0 67055 04302 4 (1 x 10 mL)
Adult Dialysis: 0 67055 04569 1 (1 x 1 mL)
SUBMISSION CONTROL NO: 126922
APPROVED: MARCH 23, 2009
RECOMBIVAX HB
®
is a Registered Trademark of Merck & Co., Inc.
Used under license.
_ _
_Product Monograph – RECOMBIVAX HB_
_®_
_ _
_Page 2 of 25_
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....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND
ADMINISTRATION..............................................................................11
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
........................................