PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Sẵn có từ:

MELIAPHARM INC

Mã ATC:

A02BC02

INN (Tên quốc tế):

PANTOPRAZOLE

Liều dùng:

40MG

Dạng dược phẩm:

TABLET (DELAYED-RELEASE)

Thành phần:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

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:

CANCELLED POST MARKET

Ngày ủy quyền:

2014-06-25

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
PANTOPRAZOLE
Pantoprazole Sodium Delayed-Release Tablets, House Standard
(as pantoprazole 20 mg, 40 mg)
H
+
, K
+
-ATPase Inhibitor
MELIAPHARM INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
January 17, 2014
Submission Control No: 170312
_ _
_PANTOPRAZOLE Product Monograph _
_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
OVERDOSAGE
................................................................................................................13
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 TRIALS
...................................