TEVA-PIROXICAM CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PIROXICAM

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

M01AC01

INN (Nama Internasional):

PIROXICAM

Dosis:

10MG

Bentuk farmasi:

CAPSULE

Komposisi:

PIROXICAM 10MG

Rute administrasi :

ORAL

Unit dalam paket:

100/250/500

Jenis Resep:

Prescription

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2014-06-12

Karakteristik produk

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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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4
1.1 Pediatrics (< 16 years of age):
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4
1.2 Geriatrics(> 65 years of age):
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4
2 CONTRAINDICATIONS
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5
3 SERIOUS WARNING AND PRECAUTIONS
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6
4 DOSAGE AND ADMINISTRATION
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7
4.1 Dosing Considerations
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7
4.2 Recommended Dose and