RIVA-OMEPRAZOLE DR TABLET (DELAYED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

OMEPRAZOLE (OMEPRAZOLE MAGNESIUM)

제공처:

LABORATOIRE RIVA INC.

ATC 코드:

A02BC01

INN (국제 이름):

OMEPRAZOLE

복용량:

20MG

약제 형태:

TABLET (DELAYED-RELEASE)

구성:

OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) 20MG

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Prescription

치료 영역:

PROTON-PUMP INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2015-08-05

제품 특성 요약

RIVA‐OMEPRAZOLE DR (Omeprazole Magnesium Delayed Release Tablets)_ _
_Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA‐OMEPRAZOLE DR
Omeprazole Magnesium Delayed Release Tablets
Delayed‐Release Tablets, 20 mg Omeprazole (as Omeprazole Magnesium),
Oral
Proton Pump Inhibitor
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Date of Initial Authorization:
FEB 26, 2013
Date of Revision:
MAR 21, 2023
Submission Control
No.: 272798
RIVA‐OMEPRAZOLE DR (Omeprazole Magnesium Delayed Release Tablets)_ _
_Page 2 of 43 _
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
..............................................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Adminis