TRIPACEL HYBRID SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

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

Available from:

SANOFI PASTEUR LIMITED

ATC code:

J07AJ52

INN (International Name):

PERTUSSIS, PURIFIED ANTIGEN, COMB. WITH TOXOIDS

Dosage:

5MCG; 3MCG; 15LF; 5LF; 20MCG; 20MCG

Pharmaceutical form:

SUSPENSION

Composition:

FIMBRIAE 5MCG; PERTACTIN 3MCG; DIPHTHERIA TOXOID 15LF; TETANUS TOXOID 5LF; PERTUSSIS TOXOID 20MCG; FILAMENTOUS HAEMAGGLUTININ 20MCG

Administration route:

INTRAMUSCULAR

Units in package:

5 X 0.5ML (1 DOSE) AMPOULES

Prescription type:

Schedule D

Therapeutic area:

TOXOIDS

Product summary:

Active ingredient group (AIG) number: 0628682001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-09-19

Summary of Product characteristics

SANOFI PASTEUR
1.3.1 PRODUCT MONOGRAPH
255 – TRIPACEL
® HYBRID
POST NOL CHANGE
CONFIDENTIAL/PROPRIETARY INFORMATION
Product Monograph Template – Schedule D
Page 1 of 28
PRODUCT MONOGRAPH
TRIPACEL
® HYBRID
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
CONTROL #: 129672
DATE OF PREPARATION:
May 2009
DATE OF APPROVAL: AUGUST 10, 2009
SANOFI PASTEUR
1.3.1 PRODUCT MONOGRAPH
255 – TRIPACEL
® HYBRID
POST NOL CHANGE
CONFIDENTIAL/PROPRIETARY INFORMATION
Product Monograph Template – Schedule D
Page 2 of 28
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................4
SUMMARY PRODUCT INFORMATION
..................................................................................4
Route of
Administration....................................................................................................................4
Dosage Form
.....................................................................................................................................4
Strength
........................................................................................................................................4
Active Ingredients
.............................................................................................................................4
Clinically Relevant Non-medicinal Ingredients
................................................................................4
DESCRIPTION
...............................................................................................................................
4
INDICATIONS AND CLINICAL USE
........................................................................................4
CONTRAINDICATIONS...............................................................................................................
5
Hypersensitivity..