NU-RANIT TAB 300MG TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-01-2009
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Active ingredient:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Available from:
NU-PHARM INC
ATC code:
A02BA02
INN (International Name):
RANITIDINE
Dosage:
300MG
Pharmaceutical form:
TABLET
Composition:
RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
HISTAMINE H2-ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0115150001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2012-09-04
Summary of Product characteristics
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............................................................................................................
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