ADACEL SUSPENSION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

FILAMENTOUS HAEMAGGLUTININ; PERTUSSIS TOXOID; PERTACTIN; DIPHTHERIA TOXOID; TETANUS TOXOID; FIMBRIAE TYPES 2 AND 3 (FIM)

MAH:

SANOFI PASTEUR LIMITED

ATC_code:

J07AJ52

INN:

PERTUSSIS, PURIFIED ANTIGEN, COMB. WITH TOXOIDS

dosage:

5MCG; 2.5MCG; 3MCG; 2LF; 5LF; 5MCG

pharmaceutical_form:

SUSPENSION

composition:

FILAMENTOUS HAEMAGGLUTININ 5MCG; PERTUSSIS TOXOID 2.5MCG; PERTACTIN 3MCG; DIPHTHERIA TOXOID 2LF; TETANUS TOXOID 5LF; FIMBRIAE TYPES 2 AND 3 (FIM) 5MCG

administration_route:

INTRAMUSCULAR

units_in_package:

1X0.5ML/5X0.5ML

prescription_type:

Schedule D

therapeutic_area:

TOXOIDS

leaflet_short:

Active ingredient group (AIG) number: 0652741001; AHFS:

authorization_status:

APPROVED

authorization_date:

2000-03-08

SPC

SANOFI PASTEUR
306 - ADACEL
® PRODUCT MONOGRAPH
_ADACEL_
_®_
_ (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis
Vaccine Adsorbed) _
_ _
_Page 1 of 51 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ADACEL
®
TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID
AND ACELLULAR PERTUSSIS VACCINE ADSORBED
Suspension for Injection
Each 0.5 mL dose contains Tetanus Toxoid (5 Lf); Diphtheria Toxoid (2
Lf); Acellular Pertussis
[Pertussis Toxoid (PT), 2.5 mcg; Filamentous Haemagglutinin (FHA), 5
mcg; Pertactin (PRN), 3
mcg and Fimbriae Types 2 and 3 (FIM), 5 mcg ].
(For immunization against Tetanus, Diphtheria and Pertussis)
ATC Code: J07AJ52
SANOFI PASTEUR LIMITED
Toronto, Ontario, Canada
Date of Initial Authorization:
May 20, 1999
Date of Revision: May 11, 2023
Submission Control Number: 270965
SANOFI PASTEUR
306 - ADACEL
® PRODUCT MONOGRAPH
_ADACEL_
_®_
_ (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis
Vaccine Adsorbed) _
_ _
_Page 2 of 51 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
09/2020
10/2021
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND
DOSAGE ADJUSTMENT
09/2020
7 WARNINGS AND PRECAUTIONS
09/2020
10/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..............................................................................................
2
TABLE OF CONTENTS
................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing
Considerations.............................................................................................
5
4