PENTACEL SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PERTACTIN; FIMBRIAE; FILAMENTOUS HAEMAGGLUTININ; PERTUSSIS TOXOID; TETANUS PROTEIN; INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 3 SAUKETT; INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 2 MEF1; INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 1 MAHONEY; HAEMOPHILUS INFLUENZAE TYPE B-PRP; TETANUS TOXOID; DIPHTHERIA TOXOID

Available from:

SANOFI PASTEUR LIMITED

ATC code:

J07CA06

INN (International Name):

DIPHT-HEMOPH INFLUEN B-PERTUSS-POLIO-TETANUS

Dosage:

3MCG; 5MCG; 20MCG; 20MCG; 30MCG; 26UNIT; 7UNIT; 29UNIT; 10MCG; 5LF; 15LF

Pharmaceutical form:

SUSPENSION

Composition:

PERTACTIN 3MCG; FIMBRIAE 5MCG; FILAMENTOUS HAEMAGGLUTININ 20MCG; PERTUSSIS TOXOID 20MCG; TETANUS PROTEIN 30MCG; INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 3 SAUKETT 26UNIT; INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 2 MEF1 7UNIT; INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 1 MAHONEY 29UNIT; HAEMOPHILUS INFLUENZAE TYPE B-PRP 10MCG; TETANUS TOXOID 5LF; DIPHTHERIA TOXOID 15LF

Administration route:

INTRAMUSCULAR

Units in package:

100

Prescription type:

Schedule D

Product summary:

Active ingredient group (AIG) number: 1162215002; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-01-27

Summary of Product characteristics

SANOFI PASTEUR 1.3.1 PRODUCT MONOGRAPH
520 – PENTACEL
®
_PENTACEL_
_®_
_ _
_[Haemophilus b Conjugate Vaccine (Tetanus Protein - Conjugate)
Reconstituted with Diphtheria and Tetanus Toxoids _
_and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated
Poliomyelitis Vaccine] _
_ _
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PENTACEL®
ACT-HIB® RECONSTITUTED WITH QUADRACEL®
HAEMOPHILUS B CONJUGATE VACCINE (TETANUS PROTEIN - CONJUGATE)
RECONSTITUTED WITH DIPHTHERIA
AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE ADSORBED COMBINED
WITH INACTIVATED
POLIOMYELITIS VACCINE
Each 0.5 mL dose contains:
Purified polyribosylribitol phosphate capsular polysaccharide (PRP) of
_Haemophilus influenzae_ type b
covalently bound to 18-30 µg of tetanus protein: 10 µg
Diphtheria Toxoid: 15 Lf, Tetanus Toxoid: 5 Lf
Acellular pertussis [Pertussis Toxoid (PT): 20 µg, Filamentous
Haemagglutinin (FHA): 20 µg, Pertactin
(PRN): 3 µg, Fimbriae types 2 and 3 (FIM): 5 µg]
Inactivated Vero Trivalent Poliovirus (vIPV): Type 1 (Mahoney): 29
D-antigen units,
Type 2 (MEF-1): 7 D-antigen units and Type 3 (Saukett): 26 D-antigen
units
Reconstituted product for injection
(For active immunization against _Haemophilus influenzae_ type b
disease,
Diphtheria, Tetanus, Pertussis and Poliomyelitis)
ATC Code: J07CA06
Sanofi Pasteur Limited
Toronto, Ontario, Canada
www.sanofi.ca
and
Sanofi Pasteur SA
Lyon, France
Date of Initial Authorization:
MAY 12, 1997
Date of Revision:
JAN 26, 2023
Submission Control Number: 261020
SANOFI PASTEUR 1.3.1 PRODUCT MONOGRAPH
520 – PENTACEL
®
_PENTACEL_
_®_
_ _
_[Haemophilus b Conjugate Vaccine (Tetanus Protein - Conjugate)
Reconstituted with Diphtheria and Tetanus Toxoids _
_and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated
Poliomyelitis Vaccine] _
_ _
_Page 2 of 35_
RECENT MAJOR LABEL CHANGES
1 Indications
01/2023
2 Contraindications
01/2023
4 Dosage and Administration, Recommended Dose and Dosage
Adjustment, 4.5 Missed Dose
01/2023
6 Dosage Forms, Stre