MENOMUNE-A/C/Y/W-135 KIT

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

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

Доступно од:

SANOFI PASTEUR LIMITED

АТЦ код:

J07AH04

INN (Међународно име):

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

Дозирање:

50MCG; 50MCG; 50MCG; 50MCG

Фармацеутски облик:

KIT

Састав:

MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP A 50MCG; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP C 50MCG; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP Y 50MCG; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP W-135 50MCG

Пут администрације:

SUBCUTANEOUS

Јединице у пакету:

0.5ML

Тип рецептора:

Schedule D

Терапеутска област:

VACCINES

Резиме производа:

Active ingredient group (AIG) number: 0440084002; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2017-04-05

Карактеристике производа

SANOFI PASTEUR
SECTION 1.3.1 PRODUCT MONOGRAPH
276 – MENOMUNE
®
- A/C/Y/W-135
Page 1 of 29
PRODUCT MONOGRAPH
MENOMUNE
® - A/C/Y/W-135
Meningococcal Polysaccharide Vaccine,
Groups A, C, Y and W-135 Combined
Powder for Solution
Active Immunizing Agent for the Prevention of Meningococcal Meningitis
ATC Code: J07AH
Manufactured by:
SANOFI PASTEUR INC.
Swiftwater, PA 18370 USA
Distributed by:
SANOFI PASTEUR LIMITED
Toronto, Ontario, Canada
CONTROL NO.:
151001 DATE OF APPROVAL: JULY 30, 2013
SANOFI PASTEUR
SECTION 1.3.1 PRODUCT MONOGRAPH
276 – MENOMUNE
®
- A/C/Y/W-135
Page 2 of 29
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 4
SUMMARY PRODUCT INFORMATION
..................................................................................
4
DESCRIPTION
...............................................................................................................................
4
INDICATIONS AND CLINICAL USE
........................................................................................
4
CONTRAINDICATIONS
...............................................................................................................
5
WARNINGS AND PRECAUTIONS
.............................................................................................
5
Immune
6
Peri-Operative
Considerations...........................................................................................................
6
Special Populations
...........................................................................................................................
7
Pregnant Women
...............................................................................................................................
7
Nursing
Women.................................................................................................................................
7
Pediatrics 7
ADVERSE REACTIONS
................................................................................................