Kraj: Kanada
Język: angielski
Źródło: Health Canada
PIROXICAM
APOTEX INC
M01AC01
PIROXICAM
20MG
CAPSULE
PIROXICAM 20MG
ORAL
100/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114612001; AHFS:
MARKETED
1986-12-31
_APO-PIROXICAM (Piroxicam capsules) _ _ _ _Page 1 of 44 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr APO-PIROXICAM Piroxicam Capsules Capsules, 10 mg and 20 mg, For Oral Use Apotex Standard Nonsteroidal Anti-inflammatory Drug (NSAID) APOTEX INC. 150 Signet Drive Toronto, Ontario Canada M9L 1T9 Date of Initial Authorization: MAR 03, 1986 Date of Revision: MAY 16, 2023 Submission Control No: 271164 _APO-PIROXICAM (Piroxicam capsules) _ _ _ _Page 2 of 44 _ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNING AND PRECAUTIONS BOX 05/2023 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 05/2023 7 WARNINGS AND PRECAUTIONS, Skin 05/2023 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations 05/2023 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 ................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS ...................................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 6 4.1 Dosing Considerations ................................................................................................. 6 4.2 Recommended Przeczytaj cały dokument