RANITIDINE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
18-09-2019
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Verzend verzoek.
Werkstoffen:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Beschikbaar vanaf:
PRO DOC LIMITEE
ATC-code:
A02BA02
INN (Algemene Internationale Benaming):
RANITIDINE
Dosering:
300MG
farmaceutische vorm:
TABLET
Samenstelling:
RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100/30
Prescription-type:
Prescription
Therapeutisch gebied:
HISTAMINE H2-ANTAGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0115150001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2023-07-10
Productkenmerken
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RANITIDINE_ _
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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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