SANDOZ ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

Sẵn có từ:

SANDOZ CANADA INCORPORATED

Mã ATC:

A02BC05

INN (Tên quốc tế):

ESOMEPRAZOLE

Liều dùng:

40MG

Dạng dược phẩm:

TABLET (DELAYED-RELEASE)

Thành phần:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 40MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

PROTON-PUMP INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0145162002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2017-01-30

Đặc tính sản phẩm

_Sandoz Esomeprazole _
_Page 1 of 49 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION PR
SANDOZ
ESOMEPRAZOLE
Esomeprazole Delayed Release Tablets
Delayed release tablets, 20 mg and 40 mg esomeprazole (as esomeprazole
magnesium
dihydrate), Oral use
H
+
, K
+
-ATPase Inhibitor
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Québec,
J4B 1E6
Submission Control Number : 265856
Date of Initial Authorization:
January
30, 2017
Date of
Preparation:
July 28, 2022
_Sandoz Esomeprazole _
_Page 2 of 49 _
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
07/2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
09/2019
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
07/2022
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
.................................................................................
5
4.1 DOSING CONSIDERATIONS
..........................................................................................
5
4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
....................................................... 5
4.3 RECONSTITUTION
......................................................................................................
7
4.4 ADMINISTRATION
.....................