ADACEL-POLIO SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FILAMENTOUS HAEMAGGLUTININ; PERTUSSIS TOXOID; PERTACTIN; TETANUS TOXOID; FIMBRIAE TYPES 2 AND 3 (FIM); POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED); POLIOVIRUS TYPE 2 MEF1 (INACTIVATED); POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED); DIPHTHERIA TOXOID

Available from:

SANOFI PASTEUR LIMITED

ATC code:

J07CA02

INN (International Name):

DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS

Dosage:

5MCG; 2.5MCG; 3MCG; 5LF; 5MCG; 29UNIT; 7UNIT; 26UNIT; 2LF

Pharmaceutical form:

SUSPENSION

Composition:

FILAMENTOUS HAEMAGGLUTININ 5MCG; PERTUSSIS TOXOID 2.5MCG; PERTACTIN 3MCG; TETANUS TOXOID 5LF; FIMBRIAE TYPES 2 AND 3 (FIM) 5MCG; POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) 29UNIT; POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) 7UNIT; POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) 26UNIT; DIPHTHERIA TOXOID 2LF

Administration route:

INTRAMUSCULAR

Units in package:

0.5ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0965263002; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-05-21

Summary of Product characteristics

Sanofi Pasteur Section 1.3.1
310 - ADACEL®-POLIO Product Monograph
_ADACEL_
_®_
_-POLIO (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular
Pertussis Vaccine Adsorbed Combined _
_with Inactivated Poliomyelitis Vaccine) _
_ _
_Page 1 of 35 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ADACEL®-POLIO
TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS
VACCINE ADSORBED
COMBINED WITH INACTIVATED POLIOMYELITIS VACCINE
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] and Inactivated
Poliomyelitis Vaccine [Type 1
(Mahoney)
1
29 D-antigen units
2
, Type 2 (MEF-1)
1
7 antigen units
2
and
Type 3 (Saukett)
1
26 D-antigen units
2
]
1
Cultivated on Vero cells
2
These antigen quantities are strictly the same as those previously
expressed as 40-8-32 D-antigen units, for virus type 1,
2 and 3 respectively, when measured by another suitable immunochemical
method.
Suspension for injection
(For immunization against Tetanus, Diphtheria, Pertussis and
Poliomyelitis)
ATC Code: J07CA02
SANOFI PASTEUR LIMITED
Toronto, Ontario, Canada
Date of Initial Authorization:
May 21, 2010
Date of Revision:
August 8, 2023
Submission Control Number: 276768
Sanofi Pasteur Section 1.3.1
310 - ADACEL®-POLIO Product Monograph
_ADACEL_
_®_
_-POLIO (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular
Pertussis Vaccine Adsorbed Combined _
_with Inactivated Poliomyelitis Vaccine) _
_ _
_Page 2 of 35 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
09/2020
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND
DOSAGE ADJUSTMENT
09/2020
6 DOSAGE FORMS, STRENGTH, COMPOSITION AND PACKAGING
06/2023
7 WARNINGS AND PRECAUTIONS
09/2020
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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