NU-RANIT TAB 150MG TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Disponible depuis:

NU-PHARM INC

Code ATC:

A02BA02

DCI (Dénomination commune internationale):

RANITIDINE

Dosage:

150MG

forme pharmaceutique:

TABLET

Composition:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HISTAMINE H2-ANTAGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0115150002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2012-09-04

Résumé des caractéristiques du produit

Page 1 of 25
PRODUCT MONOGRAPH
PR
NU-RANIT
RANITIDINE TABLETS USP
150 MG AND 300 MG RANITIDINE (AS RANITIDINE HYDROCHLORIDE)
HISTAMINE H
2
- RECEPTOR ANTAGONIST
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural Street, Units 1 & 2
JANUARY 27, 2009
Richmond Hill, Ontario
L4B 1E4
_ _
Control # 127275
Page 2 of 25
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
SUMMARY PRODUCT
INFORMATION..............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS.........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
5
DRUG
INTERACTIONS..........................................................................................................
6
DOSAGE AND ADMINISTRATION
.....................................................................................
7
OVERDOSAGE........................................................................................................................
8
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
9
STORAGE AND STABILITY
...............................................................................................
11
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................... 11
PART II: SCIENTIFIC INFORMATION
.............................................................................
12
PHARMACEUTICAL INFORMATION
...............................................................................
12
CLINICAL
TRIALS............................................................................................................