TEVA-PANTOPRAZOLE MAGNESIUM TABLET (DELAYED-RELEASE)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

PANTOPRAZOLE (PANTOPRAZOLE MAGNESIUM)

から入手可能:

TEVA CANADA LIMITED

ATCコード:

A02BC02

INN（国際名）:

PANTOPRAZOLE

投薬量:

40MG

医薬品形態:

TABLET (DELAYED-RELEASE)

構図:

PANTOPRAZOLE (PANTOPRAZOLE MAGNESIUM) 40MG

投与経路:

ORAL

パッケージ内のユニット:

30/100

処方タイプ:

Prescription

治療領域:

PROTON-PUMP INHIBITORS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2015-11-16

製品の特徴

_ _
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
_ _
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
...................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
..........................................................................