AG-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Sẵn có từ:

ANGITA PHARMA INC.

Mã ATC:

A02BC02

INN (Tên quốc tế):

PANTOPRAZOLE

Liều dùng:

40MG

Dạng dược phẩm:

TABLET (DELAYED-RELEASE)

Thành phần:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

PROTON-PUMP INHIBITORS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2018-07-13

Đặc tính sản phẩm

_Page 1 of 39_
PRODUCT MONOGRAPH
PR
AG-PANTOPRAZOLE
Pantoprazole Sodium Delayed Release Tablets USP
20 and 40 mg pantoprazole (as pantoprazole sodium sesquihydrate)
H
+
, K
+
-ATPase Inhibitor
Control Number: 214737
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Quebec
J4B 5H3
Date of Revision:
July 13, 2018
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
......................................................................................................
4
WARNINGS AND PRECAUTIONS
....................................................................................
4
ADVERSE REACTIONS
......................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
11
DOSAGE AND ADMINISTRATION
................................................................................
12
OVERDOSE
........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 14
STORAGE AND STABILITY
............................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 16
PART II: SCIENTIFIC INFORMATION
...................................................................................
17
PHARMACEUTICAL INFORMATION
............................................................................
17
CLINICAL TRIA