TEVA-PIROXICAM CAPSULE

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

PIROXICAM

Tillgänglig från:

TEVA CANADA LIMITED

ATC-kod:

M01AC01

INN (International namn):

PIROXICAM

Dos:

10MG

Läkemedelsform:

CAPSULE

Sammansättning:

PIROXICAM 10MG

Administreringssätt:

ORAL

Enheter i paketet:

100/250/500

Receptbelagda typ:

Prescription

Terapiområde:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0114612002; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2014-06-12

Produktens egenskaper

TEVA-PIROXICAM Page 1 of 45
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PIROXICAM
Piroxicam Capsules
Capsules, 10 mg and 20 mg, For Oral Use
USP
Nonsteroidal Anti-inflammatory Drug (NSAID)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 259318
Date of Authorization:
March 25, 1986
Date of Revision:
August 31, 2022
TEVA-PIROXICAM Page 2 of 45
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNING AND PRECAUTIONS BOX
08/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
08/2022
7 WARNINGS AND PRECAUTIONS, Skin
08/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
08/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1 INDICATIONS
......................................................................................................................
4
1.1 Pediatrics (< 16 years of age):
........................................................................................
4
1.2 Geriatrics(> 65 years of age):
.........................................................................................
4
2 CONTRAINDICATIONS
.........................................................................................................
5
3 SERIOUS WARNING AND PRECAUTIONS
..............................................................................
6
4 DOSAGE AND ADMINISTRATION
.........................................................................................
7
4.1 Dosing Considerations
....................................................................................................
7
4.2 Recommended Dose and