PMS-PIROXICAM SUPPOSITORIES -20MG SUPPOSITORY
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-03-2010
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Active ingredient:
PIROXICAM
Available from:
PHARMASCIENCE INC
ATC code:
M01AC01
INN (International Name):
PIROXICAM
Dosage:
20MG
Pharmaceutical form:
SUPPOSITORY
Composition:
PIROXICAM 20MG
Administration route:
RECTAL
Units in package:
30 SUPPOSITORIES
Prescription type:
Prescription
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0114612001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-10-28
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
pms-PIROXICAM
Piroxicam, USP
10 mg and 20 mg Capsules
10 mg and 20 mg Suppositories
Nonsteroidal Anti-Inflammatory Drug (NSAID)
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Avenue
February 17, 2010
Montreal, Quebec
H4P 2T4
CONTROL # 131400
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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
................................................................................................................23
ACTION AND CLINICAL
PHARMACOLOGY.............................................................23
STORAGE AND
STABILITY..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................24
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHARMACEUTICAL
INFORMATION..........................................................................26
CLINICAL TRIALS
..........................................................................................................27
DETAILED PHARMACOLOGY
.....................................................................................27
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