GEN-PIROXICAM - CAP 20MG CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PIROXICAM

Tersedia dari:

GENPHARM ULC

Kode ATC:

M01AC01

INN (Nama Internasional):

PIROXICAM

Dosis:

20MG

Bentuk farmasi:

CAPSULE

Komposisi:

PIROXICAM 20MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0114612001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2010-08-04

Karakteristik produk

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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