AG-PANTOPRAZOLE SODIUM TABLET (DELAYED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

제공처:

ANGITA PHARMA 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:

15G/50G

처방전 유형:

Prescription

치료 영역:

PROTON-PUMP INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2018-10-11

제품 특성 요약

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