DUKORAL SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, FORMALIN INACTIVATED; RECOMBINANT CHOLERA TOXIN B SUBUNIT; VIBRIO CHOLERAE INABA 6973 EL TOR BIOTYPE, FORMALIN INACTIVATED; VIBRIO CHOLERAE INABA 48 CLASSICAL BIOTYPE, HEAT INACTIVATED; VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, HEAT INACTIVATED

Available from:

VALNEVA SWEDEN AB

ATC code:

J07AE01

INN (International Name):

CHOLERA, INACTIVATED, WHOLE CELL

Dosage:

31250000000CELLS; 1MG; 31250000000CELLS; 31250000000CELLS; 31250000000CELLS

Pharmaceutical form:

SUSPENSION

Composition:

VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, FORMALIN INACTIVATED 31250000000CELLS; RECOMBINANT CHOLERA TOXIN B SUBUNIT 1MG; VIBRIO CHOLERAE INABA 6973 EL TOR BIOTYPE, FORMALIN INACTIVATED 31250000000CELLS; VIBRIO CHOLERAE INABA 48 CLASSICAL BIOTYPE, HEAT INACTIVATED 31250000000CELLS; VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, HEAT INACTIVATED 31250000000CELLS

Administration route:

ORAL

Units in package:

1 DOSE

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0548981004; AHFS:

Authorization status:

APPROVED

Authorization date:

2003-02-21

Summary of Product characteristics

_Product Monograph Master Template _
_Template Date: September 2020 _
DUKORAL®
_Oral, Inactivated Cholera and LT-producing ETEC Diarrhea Vaccine _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
DUKORAL®
Oral, Inactivated Cholera and LT-producing ETEC Diarrhea Vaccine
Oral Suspension
Active Immunizing Agent for the Prevention of Diarrhea Caused
by _Vibrio cholerae_ and/or heat-labile toxin producing
Enterotoxigenic _Escherichia coli_ (LT-ETEC)
_ _
ATC Code: J07AE01
Manufactured by:
Valneva Sweden AB,
105 21 Stockholm,
Sweden
Imported by:
Q&C Services
2000 Argentia Road, Plaza 2, Suite 220
Mississauga, Ontario, L5N 1V8
Distributed by:
Valneva Canada Inc.
600-3535, Saint-Charles Blvd.
Kirkland, Québec, H9H 5B9
Date of Initial Authorization:
February 21, 2003
Date of Revision:
June 26, 2023
Submission Control Number: 272640
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
DUKORAL®
_Oral, Inactivated Cholera and LT-producing ETEC Diarrhea Vaccine _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution
12/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
.................................................................................
4
4.1
Dosing
Considerations.........................................................................