SANDOZ PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

A02BC02

INN (Nama Internasional):

PANTOPRAZOLE

Dosis:

40MG

Bentuk farmasi:

TABLET (DELAYED-RELEASE)

Komposisi:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100/500

Jenis Resep:

Prescription

Area terapi:

PROTON-PUMP INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2008-06-03

Karakteristik produk

_Sandoz Pantoprazole (pantoprazole sodium sesquihydrate) _
_Page 1 of 53 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ PANTOPRAZOLE
Pantoprazole Sodium Sesquihydrate
Delayed-Release tablets, 20 mg, 40 mg, Oral
Proton Pump Inhibitor
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Initial Authorization:
June 3, 2008
Date of Revision:
September 27, 2023
Submission Control Number: 275889
_Sandoz Pantoprazole (pantoprazole sodium sesquihydrate) _
_Page 2 of 53 _
_ _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Endocrine and Metabolism
03/2021
1 Indications
10/2022
4.2 Recommended Dose and Dosage Adjustment
10/2022
7 Warnings and Precautions, General
10/2022
7 Warnings and Precautions, Hepatic/Biliary/Pancreatic &
Renal
10/2022
7 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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
5
1
INDICATIONS
....................................................................................................................
5
1.1
Pediatrics
...................................................................................................................
5
1.2
Geriatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
......................................................................................................
5
4
DOSAGE AND ADMINISTRATION
......................................................................................
6
4.1
Dosing Considerations
.................................................................