NIMENRIX KIT

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP A; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP C; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP W-135; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP Y; TETANUS TOXOID

Доступна з:

PFIZER CANADA ULC

Код атс:

J07AH04

ІПН (Міжнародна Ім'я):

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

Дозування:

5MCG; 5MCG; 5MCG; 5MCG; 44MCG

Фармацевтична форма:

KIT

Склад:

MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP A 5MCG; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP C 5MCG; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP W-135 5MCG; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP Y 5MCG; TETANUS TOXOID 44MCG

Адміністрація маршрут:

INTRAMUSCULAR

Одиниць в упаковці:

0.5ML/10X0.5ML

Тип рецепту:

Schedule D

Терапевтична области:

VACCINES

Огляд продуктів:

Active ingredient group (AIG) number: 0554131001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2013-03-05

Характеристики продукта

_ _
_NIMENRIX (meningococcal polysaccharide groups A, C, W-135 and Y
conjugate vaccine) Product Monograph _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
NIMENRIX®
Meningococcal polysaccharide groups A, C, W-135 and Y conjugate
vaccine
Powder and diluent for solution for injection
Active Immunizing Agent
ATC Code J07AH08
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
®
GlaxoSmithKline Biologicals SA
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC 2023
Date of Initial Authorization:
March 5, 2013
Date of Revision:
November 28, 2023
Submission Control Number: 273117
_ _
_NIMENRIX (meningococcal polysaccharide groups A, C, W-135 and Y
conjugate vaccine) Product Monograph_
_ _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION
05/2022
7 WARNINGS AND PRECAUTIONS
05/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
..............................................................................................................
4
1.2
Geriatrics
..............................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
..............................................................................