RANITIDINE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Disponible depuis:

PRO DOC LIMITEE

Code ATC:

A02BA02

DCI (Dénomination commune internationale):

RANITIDINE

Dosage:

300MG

forme pharmaceutique:

TABLET

Composition:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

Mode d'administration:

ORAL

Unités en paquet:

100/30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HISTAMINE H2-ANTAGONISTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2023-07-10

Résumé des caractéristiques du produit

_ _
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
................