GEN-PIROXICAM-CAP 10MG CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-10-2016
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Active ingredient:
PIROXICAM
Available from:
GENPHARM ULC
ATC code:
M01AC01
INN (International Name):
PIROXICAM
Dosage:
10MG
Pharmaceutical form:
CAPSULE
Composition:
PIROXICAM 10MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0114612002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2010-08-04
Summary of Product characteristics
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_Page 1 of 35_
PRODUCT MONOGRAPH
PR
GEN-PIROXICAM
(Piroxicam, USP)
10 and 20 mg Capsules
Nonsteroidal Anti-inflammatory Drug (NSAID)
Genpharm ULC
85 Advance Road
Etobicoke, ON
Canada
M8Z 2S6
DATE OF REVISION:
December 01, 2009
CONTROL NO: 129679
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_Page 2 of 35_
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS..................................................................................................14
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND
ADMINISTRATION..............................................................................22
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND
STABILITY..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL
INFORMATION..........................................................................27
CLINICAL
TRIALS..........................................................................................................27
DETAIL
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