OMEPRAZOLE CAPSULE (DELAYED RELEASE)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

OMEPRAZOLE

から入手可能:

PRO DOC LIMITEE

ATCコード:

A02BC01

INN（国際名）:

OMEPRAZOLE

投薬量:

20MG

医薬品形態:

CAPSULE (DELAYED RELEASE)

構図:

OMEPRAZOLE 20MG

投与経路:

ORAL

パッケージ内のユニット:

100/500

処方タイプ:

Prescription

治療領域:

PROTON-PUMP INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0121643001; AHFS:

認証ステータス:

APPROVED

承認日:

2010-02-05

製品の特徴

_OMEPRAZOLE (Omeprazole delayed-release capsules) _
_Page 1 of 49 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OMEPRAZOLE
Omeprazole Delayed-Release Capsules
Capsules (delayed release), 20 mg, Oral
Manufacturer’s Standard
Proton Pump Inhibitor
PRO DOC LTÉE
2925 boul. Industriel
Laval, Québec
H7L 3W9
Submission Control Number: 279464
Date of Initial Authorization:
FEB 05, 2010
Date of Revision:
OCT 13, 2023
_OMEPRAZOLE (Omeprazole delayed-release capsules) _
_Page 2 of 49 _
RECENT MAJOR LABEL CHANGES
Not applicable.
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
.................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.4
Administration
.........................................................................................................
7
4.5
Missed Dose
...........................................