RANITIDINE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
18-09-2019
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Aktiv ingrediens:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Tilgjengelig fra:
PRO DOC LIMITEE
ATC-kode:
A02BA02
INN (International Name):
RANITIDINE
Dosering :
300MG
Legemiddelform:
TABLET
Sammensetning:
RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG
Administreringsrute:
ORAL
Enheter i pakken:
100/30
Resept typen:
Prescription
Terapeutisk område:
HISTAMINE H2-ANTAGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0115150001; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2023-07-10
Preparatomtale
_ _
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
................
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