País: Canadá
Idioma: inglés
Fuente: Health Canada
KETOPROFEN
AA PHARMA INC
M01AE03
KETOPROFEN
50MG
CAPSULE
KETOPROFEN 50MG
ORAL
100
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0110497001; AHFS:
APPROVED
2011-02-16
_Pr_ _KETOPROFEN, _ _Pr_ _KETOPROFEN-E and _ _Pr_ _KETOPROFEN SR (Ketoprofen)_ _ _ _Page 1 of 49_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr KETOPROFEN Ketoprofen Capsules BP Capsule, 50 mg, for oral use Pr KETOPROFEN-E Ketoprofen Enteric-coated Tablets Tablet, 50 mg and 100 mg, for oral use Pr KETOPROFEN SR Ketoprofen Sustained-release Tablets Tablet, 200 mg, for oral use Non-Steroidal Anti-inflammatory Drug (NSAID) AA PHARMA INC. 1165 Creditstone Road, Unit #1 Vaughan, Ontario L4K 4N7 Date of Initial Authorization: DEC 31, 1989 Date of Revision: MAY 10, 2022 Submission Control Number: 258038 _ _ _Pr_ _KETOPROFEN, _ _Pr_ _KETOPROFEN-E and _ _Pr_ _KETOPROFEN SR (Ketoprofen)_ _ _ _Page 2 of 49_ RECENT MAJOR LABEL CHANGES 1 Indications 05/2022 2 Contraindications 05/2022 3 Serious Warnings and Precautions Box 05/2022 4 Dosage and Administration, 4.1 Dosing Considerations 05/2022 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 05/2022 4 Dosage and Administration, 4.4 Administration 05/2022 7 Warnings and Precautions 05/2022 7 Warnings and Precautions, 7.1.1 Pregnant Women 05/2022 7 Warnings and Precautions, 7.1.2 Breast-feeding 05/2022 7 Warnings and Precautions, 7.1.4 Geriatrics 05/2022 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 ............................................................................................................4 1.2 Geriatrics........................................................ Leer el documento completo