NU-RANIT TAB 300MG TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Sẵn có từ:

NU-PHARM INC

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

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:

2012-09-04

Đặc tính sản phẩm

Page 1 of 25
PRODUCT MONOGRAPH
PR
NU-RANIT
RANITIDINE TABLETS USP
150 MG AND 300 MG RANITIDINE (AS RANITIDINE HYDROCHLORIDE)
HISTAMINE H
2
- RECEPTOR ANTAGONIST
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural Street, Units 1 & 2
JANUARY 27, 2009
Richmond Hill, Ontario
L4B 1E4
_ _
Control # 127275
Page 2 of 25
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
SUMMARY PRODUCT
INFORMATION..............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS.........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
5
DRUG
INTERACTIONS..........................................................................................................
6
DOSAGE AND ADMINISTRATION
.....................................................................................
7
OVERDOSAGE........................................................................................................................
8
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
9
STORAGE AND STABILITY
...............................................................................................
11
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................... 11
PART II: SCIENTIFIC INFORMATION
.............................................................................
12
PHARMACEUTICAL INFORMATION
...............................................................................
12
CLINICAL
TRIALS............................................................................................................