TEVA-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

A02BC02

INN (International Name):

PANTOPRAZOLE

Dosering :

20MG

Legemiddelform:

TABLET (DELAYED-RELEASE)

Sammensetning:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 20MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

PROTON-PUMP INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2008-04-11

Preparatomtale

TEVA-PANTOPRAZOLE _(pantoprazole sodium sesquihydrate)_
Page 1 of 52
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PANTOPRAZOLE
Pantoprazole Delayed-Release Tablets, 20 mg, 40 mg, Oral
(as pantoprazole sodium sesquihydrate)
Teva Standard
Proton Pump Inhibitor
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
April 11, 2008
Toronto, Ontario
M1B 2K9
Date of Revision:
September 19, 2023
Submission Control Number: 275827
TEVA-PANTOPRAZOLE _(pantoprazole sodium sesquihydrate)_
Page 2 of 52
-
RECENT MAJOR LABEL CHANGES
7.0 WARNINGS AND PRECAUTIONS, Immune
09/2023
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
.........................................................................................................