TEVA-PANTOPRAZOLE MAGNESIUM TABLET (DELAYED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PANTOPRAZOLE (PANTOPRAZOLE MAGNESIUM)

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

A02BC02

INN (Nama Internasional):

PANTOPRAZOLE

Dosis:

40MG

Bentuk farmasi:

TABLET (DELAYED-RELEASE)

Komposisi:

PANTOPRAZOLE (PANTOPRAZOLE MAGNESIUM) 40MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

PROTON-PUMP INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-11-16

Karakteristik produk

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TEVA-PANTOPRAZOLE MAGNESIUM (pantoprazole magnesium)
Page 1 of 55
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR TEVA-PANTOPRAZOLE MAGNESIUM
Pantoprazole Magnesium Enteric-Coated Tablets
Tablets, 40 mg pantoprazole (as pantoprazole magnesium), Oral
Proton Pump Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Date of Initial Authorization:
NOV 16, 2015
Date of Revision:
NOV 21, 2023
www.tevacanada.com
Submission Control Number: 277792
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TEVA-PANTOPRAZOLE MAGNESIUM (pantoprazole magnesium)
_ _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
11/2023
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
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
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