PMS-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Available from:

PHARMASCIENCE INC

ATC code:

A02BC02

INN (International Name):

PANTOPRAZOLE

Dosage:

40MG

Pharmaceutical form:

TABLET (DELAYED-RELEASE)

Composition:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

PROTON-PUMP INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0133229001; AHFS:

Authorization status:

APPROVED

Authorization date:

2008-06-03

Summary of Product characteristics

_pms-PANTOPRAZOLE _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-PANTOPRAZOLE
Pantoprazole Sodium
Delayed-Release Tablets, 20 mg and 40 mg, Oral
House Standard (20 mg) & USP (40 mg)
Proton Pump Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number:
275567
Date of Initial Authorization:
FEB 7, 2007
Date of Revision:
SEP 19, 2023
_pms-PANTOPRAZOLE _
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RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Immune
05/2023
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
1.1
Pediatrics
.......................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
4
4
DOSAGE AND ADMINISTRATION
......................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................. 5
4.4
Administration
..............................................................................................................
6
4.5
Mis