PMS-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

A02BC02

INN (Nama Antarabangsa):

PANTOPRAZOLE

Dos:

40MG

Borang farmaseutikal:

TABLET (DELAYED-RELEASE)

Komposisi:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

PROTON-PUMP INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2008-06-03

Ciri produk

_pms-PANTOPRAZOLE _
_Page 1 of 53_
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 _
_Page 2 of 53_
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