RANITIDINE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
18-09-2019
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Aktívna zložka:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Dostupné z:
PRO DOC LIMITEE
ATC kód:
A02BA02
INN (Medzinárodný Name):
RANITIDINE
Dávkovanie:
300MG
Forma lieku:
TABLET
Zloženie:
RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG
Spôsob podávania:
ORAL
Počet v balení:
100/30
Typ predpisu:
Prescription
Terapeutické oblasti:
HISTAMINE H2-ANTAGONISTS
Prehľad produktov:
Active ingredient group (AIG) number: 0115150001; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2023-07-10
Súhrn charakteristických
_ _
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_ _
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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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