MENJUGATE POWDER FOR SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MENINGOCOCCAL GROUP C OLIGOSACCHARIDE; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN

Available from:

GLAXOSMITHKLINE INC

ATC code:

J07AH

INN (International Name):

MENINGOCOCCAL VACCINES

Dosage:

10MCG; 25MCG

Pharmaceutical form:

POWDER FOR SUSPENSION

Composition:

MENINGOCOCCAL GROUP C OLIGOSACCHARIDE 10MCG; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 25MCG

Administration route:

INTRAMUSCULAR

Units in package:

0.6 ML

Prescription type:

Schedule D

Therapeutic area:

TOXOIDS

Product summary:

Active ingredient group (AIG) number: 0243741001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-10-18

Summary of Product characteristics

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_Menjugate - Product Monograph _
_Page 1 of 23_
PRODUCT MONOGRAPH
MENJUGATE
Meningococcal Group C–CRM197 Conjugate Vaccine
House Standard
Powder for Suspension
Active Immunizing Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Approval:
October 20, 2017
Control # : 208210
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_©_
_2017GSK group of companies or its licensor_
Trademarks are owned by or licensed to the GSK group of companies
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_Menjugate - Product Monograph _
_Page 2 of 23_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
ADVERSE REACTIONS
...................................................................................................
5
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
...............................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 12
STORAGE AND STABILITY
.........................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
......................................................................................................