NU-RANIT TAB 300MG TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
27-01-2009
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Werkstoffen:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Beschikbaar vanaf:
NU-PHARM INC
ATC-code:
A02BA02
INN (Algemene Internationale Benaming):
RANITIDINE
Dosering:
300MG
farmaceutische vorm:
TABLET
Samenstelling:
RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
HISTAMINE H2-ANTAGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0115150001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2012-09-04
Productkenmerken
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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