APO-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Beschikbaar vanaf:

APOTEX INC

ATC-code:

A02BC02

INN (Algemene Internationale Benaming):

PANTOPRAZOLE

Dosering:

20MG

farmaceutische vorm:

TABLET (DELAYED-RELEASE)

Samenstelling:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 20MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

PROTON-PUMP INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0133229002; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2008-03-05

Productkenmerken

_APO-PANTOPRAZOLE (pantoprazole sodium) _
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_Page 1 of 53 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-PANTOPRAZOLE
Pantoprazole Sodium Delayed-Release Tablets
Delayed-Release Tablets, 20 mg and 40 mg pantoprazole (as pantoprazole
sodium), Oral
USP
Proton Pump Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario M9L 1T9
Date of Initial Authorization:
March 5, 2008
Date of Revision:
November 8, 2023
Submission Control Number: 273811
_APO-PANTOPRAZOLE (pantoprazole sodium) _
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_Page 2 of 53 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
06/2023
7 WARNINGS AND PRECAUTIONS,
Immune
06/2023
7 WARNINGS AND PRECAUTIONS, Skin
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
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