RIVA-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

제공처:

LABORATOIRE RIVA INC.

ATC 코드:

A02BC02

INN (국제 이름):

PANTOPRAZOLE

복용량:

40MG

약제 형태:

TABLET (DELAYED-RELEASE)

구성:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

관리 경로:

ORAL

패키지 단위:

500

처방전 유형:

Prescription

치료 영역:

PROTON-PUMP INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2021-09-02

제품 특성 요약

_RIVA-PANTOPRAZOLE (pantoprazole sodium sesquihydrate) _
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_Page 1 of 48 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA-PANTOPRAZOLE
Pantoprazole Delayed-Release Tablets
Delayed-Release Tablets, 40 mg pantoprazole (as pantoprazole sodium
sesquihydrate), Oral
Proton Pump Inhibitor
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control Number: 281203
Date of Initial Authorization:
OCT 23, 2008
Date of Revision:
DEC 06, 2023
_RIVA-PANTOPRAZOLE (pantoprazole sodium sesquihydrate) _
_ _
_Page 2 of 48 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
05/2021
1 INDICATIONS
01/2023
4.2 Recommended Dose and Dosage Adjustment
01/2023
7 WARNINGS AND PRECAUTIONS, General
01/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic & Renal
01/2023
7 WARNINGS AND PRECAUTIONS, Immune
12/2023
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
.....................................................................
5
1
INDICATIONS
.................................................................................................................
5
1.1
Pediatrics
.....................................................................................................................
5
1.2
Geriatrics
.....................................................................................................................
5
2
CONTRAINDICATIONS
....................................................................................................
5
4
DOSAGE AND ADMINISTRATION
....................................................................................
6
4.1
Dosing Considerations
..............