Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
KETOROLAC TROMETHAMINE
AA PHARMA INC
S01BC05
KETOROLAC
0.5%
SOLUTION
KETOROLAC TROMETHAMINE 0.5%
OPHTHALMIC
5ML/10ML
Prescription
NONSTEROIDAL ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0121995003; AHFS:
APPROVED
2012-07-06
_KETOROLAC (ketorolac tromethamine ophthalmic solution) _ _Page 1 of 21 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr KETOROLAC Ketorolac Tromethamine Ophthalmic Solution Solution, 0.5% w/v, for ophthalmic use with benzalkonium chloride 0.01% w/v as preservative Topical Non-Steroidal Anti-Inflammatory Agent ATC code: S01BC05 AA PHARMA INC. 1165 Creditstone Road, Unit #1 Vaughan, Ontario L4K 4N7 Date of Initial Authorization: May 27, 2002 Date of Revision: August 28, 2023 Submission Control Number.: 273938 _KETOROLAC (ketorolac tromethamine ophthalmic solution) _ _Page 2 of 21 _ RECENT MAJOR LABEL CHANGES None at the time of the most recent authorization. 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: .................................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................... 4 4 DOSAGE AND ADMINISTRATION .................................................................................... 4 4.1 Dosing Considerations ................................................................................................ 4 4.2 Recommended Dose and Dosage Adjustment ........................................................... 4 4.4 Administration .......... Prečítajte si celý dokument