NU-RANIT TAB 300MG TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Saatavilla:

NU-PHARM INC

ATC-koodi:

A02BA02

INN (Kansainvälinen yleisnimi):

RANITIDINE

Annos:

300MG

Lääkemuoto:

TABLET

Koostumus:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HISTAMINE H2-ANTAGONISTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2012-09-04

Valmisteyhteenveto

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