RANITIDINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Sẵn có từ:

PRO DOC LIMITEE

Mã ATC:

A02BA02

INN (Tên quốc tế):

RANITIDINE

Liều dùng:

300MG

Dạng dược phẩm:

TABLET

Thành phần:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100/30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HISTAMINE H2-ANTAGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0115150001; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2023-07-10

Đặc tính sản phẩm

_ _
RANITIDINE_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
PR RANITIDINE
Ranitidine Tablets, USP
150 mg & 300 mg ranitidine (as ranitidine hydrochloride)
Histamine H
2
-receptor antagonist
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
September 18, 2019
Submission Control No: 229390
RANITIDINE_ _
_Page 2 of 28_
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
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
................................................................................13
PHARMACEUTICAL INFORMATION
..........................................................................13
CLINICAL TRIALS
..........................................................................................................14
DETAILED PHARMACOLOGY
................