APO-PRUCALOPRIDE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)

Sẵn có từ:

APOTEX INC

Mã ATC:

A06AX05

INN (Tên quốc tế):

PRUCALOPRIDE

Liều dùng:

2MG

Dạng dược phẩm:

TABLET

Thành phần:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE) 2MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS GI DRUGS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0153049002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-12-09

Đặc tính sản phẩm

Page 1 of 37
PRODUCT MONOGRAPH
PR
APO-PRUCALOPRIDE
Prucalopride Tablets
1 mg and 2 mg prucalopride as prucalopride succinate
Prokinetic agent
Apotex. Inc.
Date of Preparation:
150 Signet Drive
August 15, 2019
Toronto Ontario
M9L 1T9
Submission Control No: 223407
Page 2 of 37
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
................................................................................................................
6
DRUG INTERACTIONS
..............................................................................................................
11
DOSAGE AND ADMINISTRATION
..........................................................................................
12
OVERDOSAGE
.............................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
13
STORAGE AND STABILITY
......................................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 16
PART II: SCIENTIFIC INFORMATION
.........................................................................................
18
PHARMACEUTICAL INFORMATION
.................