MENOMUNE-A/C/Y/W-135 POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

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

Dostępny od:

SANOFI PASTEUR LIMITED

Kod ATC:

J07AH04

INN (International Nazwa):

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

Dawkowanie:

500MCG; 500MCG; 500MCG; 500MCG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP A 500MCG; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP C 500MCG; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP Y 500MCG; MENINGOCOCCAL POLYSACCHARIDE ANTIGEN GROUP W-135 500MCG

Droga podania:

SUBCUTANEOUS

Sztuk w opakowaniu:

6 ML

Typ recepty:

Schedule D

Dziedzina terapeutyczna:

VACCINES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0440084001; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2017-04-05

Charakterystyka produktu

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
................................................................................................