RECOMBIVAX HB (WITH PRESERVATIVE) SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

HEPATITIS B SURFACE ANTIGEN (RECOMBINANT)

Commercializzato da:

MERCK CANADA INC

Codice ATC:

J07BC01

INN (Nome Internazionale):

HEPATITIS B, PURIFIED ANTIGEN

Dosaggio:

10MCG

Forma farmaceutica:

SOLUTION

Composizione:

HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10MCG

Via di somministrazione:

INTRAMUSCULAR

Confezione:

3ML/10X3ML

Tipo di ricetta:

Schedule D

Area terapeutica:

VACCINES

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2010-03-08

Scheda tecnica

_ 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
........................................