MENVEO SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MENINGOCOCCAL GROUP A OLIGOSACCHARIDE; MENINGOCOCCAL GROUP C OLIGOSACCHARIDE; MENINGOCOCCAL GROUP W-135 OLIGOSACCHARIDE; MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN

Available from:

GLAXOSMITHKLINE INC

ATC code:

J07AH08

INN (International Name):

MENINGOCOCCUS, A, C, Y, W-135, TETRAVAL. PURIFIED POLYSACC. ANTIGEN CONJUGATED

Dosage:

10MCG; 5MCG; 5MCG; 5MCG; 47MCG

Pharmaceutical form:

SOLUTION

Composition:

MENINGOCOCCAL GROUP A OLIGOSACCHARIDE 10MCG; MENINGOCOCCAL GROUP C OLIGOSACCHARIDE 5MCG; MENINGOCOCCAL GROUP W-135 OLIGOSACCHARIDE 5MCG; MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE 5MCG; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 47MCG

Administration route:

INTRAMUSCULAR

Units in package:

0.5ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0552705002; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-05-21

Summary of Product characteristics

_ _
_Page 1 of 43_
PRODUCT MONOGRAPH
MENVEO
Meningococcal (Groups A, C, W-135 and Y) Oligosaccharide CRM
197
Conjugate Vaccine
Powder and solution for injection
Active Immunizing Agent
ATC Code J07AH08
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
DATE OF INITIAL APPROVAL:
May 21
st
, 2010
DATE OF REVISION:
June 3, 2020
SUBMISSION CONTROL NO: 236611
_©_
_2020 GlaxoSmithKline Inc., All Rights Reserved _
_Trademarks are owned by or licensed to the GSK group of companies. _
_MENACTRA is a trademark of Sanofi Pasteur Limited._
_GARDASIL 9 is a trademark of Merck Canada Inc._
_MENOMUNE_
_is a trademark of Sanofi Pasteur Limited. _
_ _
_Page 2 of 43_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
4
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
...............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
........................................................................................