RECOMBIVAX HB SUSPENSION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

HEPATITIS B SURFACE ANTIGEN (RECOMBINANT)

可用日期:

MERCK CANADA INC

ATC代码:

J07BC01

INN（国际名称）:

HEPATITIS B, PURIFIED ANTIGEN

剂量:

40MCG

药物剂型:

SUSPENSION

组成:

HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 40MCG

给药途径:

INTRAMUSCULAR

每包单位数:

1ML

处方类型:

Schedule D

治疗领域:

VACCINES

產品總結:

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

授权状态:

APPROVED

授权日期:

2005-09-14

产品特点

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