NEXIUM 24HR CAPSULE (DELAYED RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

Sẵn có từ:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

Mã ATC:

A02BC05

INN (Tên quốc tế):

ESOMEPRAZOLE

Liều dùng:

20MG

Dạng dược phẩm:

CAPSULE (DELAYED RELEASE)

Thành phần:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

14

Loại thuốc theo toa:

OTC

Khu trị liệu:

PROTON-PUMP INHIBITORS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2016-08-04

Đặc tính sản phẩm

NEXIUM
®
24HR
Page 1 of 37
Esomeprazole Magnesium Delayed-Release Capsules USP
PRODUCT MONOGRAPH
Including Patient Medication Information
NEXIUM
®
24HR
Esomeprazole Magnesium Delayed-Release Capsules USP
Delayed-Release Capsules, 20 mg Esomeprazole (as Esomeprazole
Magnesium Trihydrate),
Oral
USP
H
+
, K
+
-ATPase Inhibitor/Acid Reducer
GlaxoSmithKline Consumer Healthcare ULC
7333 Mississauga Road, Mississauga,
Ontario L5N 6L4
Date of Initial Authorization: Aug 10,
2016
Submission Control No. 277914
Date of Revision: January 22, 2024
NEXIUM
®
24HR
Page 2 of 37
Esomeprazole Magnesium Delayed-Release Capsules USP
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
1
INDICATIONS............................................................................................................
3
1.1 Pediatrics
.........................................................................................................
3
1.2 Geriatrics
.........................................................................................................
3
2 CONTRAINDICATIONS
............................................................................................
3
4 DOSAGE AND ADMINISTRATION
...........................................................................
3
4.1 Dosing Considerations
....................................................................................
3
4.2 Recommended Dose and Dosage Adjustment
............................................... 4
4.4 Administration
..................................................................................................
4
4.5 Missed Dose
....................................................................................................
4
5 OVERDOSAGE
......................................