MENJUGATE LIQUID SUSPENSION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

MENINGOCOCCAL GROUP C OLIGOSACCHARIDE; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN

זמין מ:

GLAXOSMITHKLINE INC

קוד ATC:

J07AH

INN (שם בינלאומי):

MENINGOCOCCAL VACCINES

כמות:

10MCG; 25MCG

טופס פרצבטיות:

SUSPENSION

הרכב:

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

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

0.5ML

סוג מרשם:

Schedule D

איזור תרפויטי:

TOXOIDS

leaflet_short:

Active ingredient group (AIG) number: 0243741003; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2015-12-16

מאפייני מוצר

_ _
_Page 1 of 25_
PRODUCT MONOGRAPH
MENJUGATE
LIQUID
10 micrograms suspension for injection
Meningococcal Group C Conjugate Vaccine
House Standard
Suspension for Injection
Active Immunizing Agent
ATC Code J07A H
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
DATE OF INITIAL APPROVAL:
June 17, 2015
DATE OF REVISION:
June 28, 2019
SUBMISSION CONTROL #: 226119
_ _
_©_
_2019 GSK group of companies or its licensor _
Trademarks are owned by or licensed to the GSK group of companies
_PENTACEL is a trademark of Sanofi Pasteur Limited. _
_ _
_Page 2 of 25_
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_Page 3 of 25_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 4
SUMMARY PRODUCT INFORMATION
.......................................................................
4
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARM