ZANTAC TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

제공처:

SANOFI CONSUMER HEALTH INC

ATC 코드:

A02BA02

INN (International Name):

RANITIDINE

복용량:

75MG

약제 형태:

TABLET

구성:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 75MG

관리 경로:

ORAL

패키지 단위:

2/4/10/30/60/124

처방전 유형:

OTC

치료 영역:

HISTAMINE H2-ANTAGONISTS

제품 요약:

Active ingredient group (AIG) number: 0115150003; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2022-02-18

제품 특성 요약

_ _
_ZANTAC_
_®_
_ and ZANTAC_
_®_
_ Maximum Strength Non-Prescription Tablets _
_Page 1 of 35_
PRODUCT MONOGRAPH
ZANTAC
®
Ranitidine Tablets USP 75 mg (as ranitidine hydrochloride)
ZANTAC
® MAXIMUM STRENGTH NON-PRESCRIPTION
Ranitidine Tablets USP 150 mg (as ranitidine hydrochloride)
Histamine H
2
-receptor antagonist
Sanofi Consumer Health Inc.
2905 Place Louis-R. Renaud
Laval, QC, Canada H7V 0A3
Date of Revision:
December 5, 2019
Submission Control No: 231962
_ _
_ZANTAC_
_®_
_ and ZANTAC_
_®_
_ Maximum Strength Non-Prescription Tablets _
_Page 2 of 35 _
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
....................................................................................................7
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
.........