PMSC-ESOMEPRAZOLE DR TABLET (DELAYED-RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

可用日期:

PHARMASCIENCE INC

ATC代码:

A02BC05

INN（国际名称）:

ESOMEPRAZOLE

剂量:

20MG

药物剂型:

TABLET (DELAYED-RELEASE)

组成:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 20MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

產品總結:

Active ingredient group (AIG) number: 0145162001; AHFS:

授权状态:

APPROVED

授权日期:

2022-06-28

产品特点

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMSC-ESOMEPRAZOLE DR
Esomeprazole Delayed Release Tablets
Delayed release tablets, 20 mg, 40 mg, Oral use
H
+
, K
+
-ATPase Inhibitor
Submission Control No.: 254119
PHARMASCIENCE INC
6111 Royalmount Ave., Suite 100
Montréal,
Quebec
Canada
H4P 2T4
Date
of
Initial
Authorization:
June 28, 2022
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
06-2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
06-2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
06-2022
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
2
CONTRAINDICATIONS
...........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
...........................................................................................
4
4.1
Dosing Considerations
...........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................................
5
4.4
Administration
........................................................................................................................
6
4.5
Missed Dose
..................................................................................