TRIPACEL SUSPENSION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

PERTACTIN; FIMBRIAE; FILAMENTOUS HAEMAGGLUTININ; PERTUSSIS TOXOID; TETANUS TOXOID; DIPHTHERIA TOXOID

MAH:

SANOFI PASTEUR LIMITED

ATC_code:

J07AJ52

INN:

PERTUSSIS, PURIFIED ANTIGEN, COMB. WITH TOXOIDS

dosage:

3MCG; 5MCG; 5MCG; 10MCG; 5LF; 15LF

pharmaceutical_form:

SUSPENSION

composition:

PERTACTIN 3MCG; FIMBRIAE 5MCG; FILAMENTOUS HAEMAGGLUTININ 5MCG; PERTUSSIS TOXOID 10MCG; TETANUS TOXOID 5LF; DIPHTHERIA TOXOID 15LF

administration_route:

INTRAMUSCULAR

units_in_package:

100

prescription_type:

Schedule D

therapeutic_area:

TOXOIDS

leaflet_short:

Active ingredient group (AIG) number: 0628682002; AHFS:

authorization_status:

APPROVED

authorization_date:

2005-11-08

SPC

SANOFI PASTEUR
1.3.1 PRODUCT MONOGRAPH
253 – TRIPACEL
®
Page 1 of 32
PRODUCT MONOGRAPH
TRIPACEL
®
DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE
ADSORBED
Suspension for injection
(For active immunization against Diphtheria, Tetanus and Pertussis)
ATC Code: J07AJ52
SANOFI PASTEUR LIMITED
Toronto, Ontario, Canada
DATE OF REVISION: April 2013
Control# 164493,
Date of Approval: May 29, 2013
SANOFI PASTEUR
1.3.1 PRODUCT MONOGRAPH
253 – TRIPACEL
®
Page 2 of 32
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 5
SUMMARY PRODUCT INFORMATION
.............................................................................
5
DESCRIPTION
...........................................................................................................................
5
INDICATIONS AND CLINICAL USE
....................................................................................
5
Pediatrics
.................................................................................................................................
6
Geriatrics
.................................................................................................................................
6
CONTRAINDICATIONS
..........................................................................................................
6
Hypersensitivity
.......................................................................................................................
6
Neurological Disorders
............................................................................................................
6
WARNINGS AND PRECAUTIONS
........................................................................................
6
General
.................................................................................................................................
6
Hematologic
.............................................................................................................................
7
Immune