RANITIDINE NON PRESCRIPTION TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

A02BA02

INN (국제 이름):

RANITIDINE

복용량:

150MG

약제 형태:

TABLET

구성:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

관리 경로:

ORAL

패키지 단위:

30/60/100

처방전 유형:

OTC

치료 영역:

HISTAMINE H2-ANTAGONISTS

제품 요약:

Active ingredient group (AIG) number: 0115150002; AHFS:

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2017-06-16

제품 특성 요약

Ranitidine Non Prescription
Page 1 of 27
PRODUCT MONOGRAPH
RANITIDINE NON PRESCRIPTION
Ranitidine (as Ranitidine hydrochloride) Tablets BP
150 mg
Histamine H
2
Receptor Antagonist
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 15, 2017
Boucherville, QC, Canada
J4B 7K8
Control No.: 202278
Ranitidine Non Prescription
Page 2 of 27
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................................
3
INDICATIONS
AND CLINICAL USE
..............................................................................................
3
CONTRAINDICATIONS
..................................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................................
3
ADVERSE REACTIONS
...................................................................................................................
4
DRUG INTERACTIONS
...................................................................................................................
5
DOSAGE AND ADMINISTRATION
...............................................................................................
7
OVERDOSAGE
.................................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................
8
STORAGE AND STABILITY
.........................................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................................ 12
PART II: SCIENTIFIC INFORMATION
......................................................................................
13
PHARMACEUTICAL INFORMATION
....................................