AG-PANTOPRAZOLE SODIUM TABLET (DELAYED-RELEASE)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

から入手可能:

ANGITA PHARMA INC.

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 SODIUM SESQUIHYDRATE) 40MG

投与経路:

ORAL

パッケージ内のユニット:

15G/50G

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:

2018-10-11

製品の特徴

AG-PANTOPRAZOLE SODIUM Page 1 of 46
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-PANTOPRAZOLE SODIUM
Pantoprazole Sodium Delayed-Release Tablets
Delayed-Release Tablet, 20 mg and 40 mg pantoprazole
(as pantoprazole sodium sesquihydrate), Oral
USP
Proton Pump Inhibitor
Angita Pharma Inc
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
October 11, 2018
Date of Revision:
September 27, 2023
Submission Control Number: 273071
AG-PANTOPRAZOLE SODIUM Page 2 of 46
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Endocrine and Metabolism
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 (< 18 years of age)
..................................................................................
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
Missed