国家: 加拿大
语言: 英文
来源: Health Canada
PIROXICAM
TEVA CANADA LIMITED
M01AC01
PIROXICAM
10MG
CAPSULE
PIROXICAM 10MG
ORAL
100/250/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114612002; AHFS:
APPROVED
2014-06-12
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 阅读完整的文件