TEVA-PIROXICAM CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PIROXICAM

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

M01AC01

INN (International Adı):

PIROXICAM

Doz:

10MG

Farmasötik formu:

CAPSULE

Kompozisyon:

PIROXICAM 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/250/500

Reçete türü:

Prescription

Terapötik alanı:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2014-06-12

Ürün özellikleri

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