RANITIDINE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

MAH:

PRO DOC LIMITEE

ATC_code:

A02BA02

INN:

RANITIDINE

dosage:

300MG

pharmaceutical_form:

TABLET

composition:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

administration_route:

ORAL

units_in_package:

100/30

prescription_type:

Prescription

therapeutic_area:

HISTAMINE H2-ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0115150001; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2023-07-10

SPC

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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
................