RECOMBIVAX HB SUSPENSION

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:

40MCG

Pharmaceutical form:

SUSPENSION

Composition:

HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 40MCG

Administration route:

INTRAMUSCULAR

Units in package:

1ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0119570003; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-09-14

Summary of Product characteristics

RECOMBIVAX HB
®
(hepatitis B vaccine [recombinant])
_Page 1 of 26_
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 CANADA INC.
16750 route Transcanadienne
Kirkland, Quebec H9H 4M7
Date of Revision:
May 15, 2012
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 Dialysis: 0 67055 04560 8 (1 x 1 mL)
SUBMISSION CONTROL NO: 155287
DATE OF APPROVAL: MAY 22, 2012
_ _
RECOMBIVAX HB
®
(hepatitis B vaccine [recombinant])
_Page 2 of 26_
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
....................................................................................................9
DOSAGE AND
ADMINISTRATION..............................................................................10
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND
STABILITY..........................................................................................15
DOSAGE