Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)
HIKMA CANADA LIMITED
S01ED51
TIMOLOL, COMBINATIONS
20MG; 5MG
SOLUTION
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG; TIMOLOL (TIMOLOL MALEATE) 5MG
OPHTHALMIC
15G/50G
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0237301001; AHFS:
APPROVED
2019-07-11
_DORZOLAMIDE AND TIMOLOL EYE DROPS BP_ _ _ _(dorzolamide hydrochloride and timolol maleate) _ _Page 1 of 37_ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DORZOLAMIDE AND TIMOLOL EYE DROPS BP Solution, 20 mg/mL dorzolamide hydrochloride and 5 mg/mL timolol maleate, Ophthalmic BP Elevated Intraocular Pressure Therapy (Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic Blocking Agent) Hikma Canada Limited 5995 Avebury Road, Suite 804 Mississauga, Ontario L5R 3P9 Date of Initial Authorization: MAY 24, 2022 Date of Revision: APR 6, 2023 Submission Control Number: 273317 _DORZOLAMIDE AND TIMOLOL EYE DROPS BP_ _ _ _(dorzolamide hydrochloride and timolol maleate) _ _Page 2 of 37_ _ _ RECENT MAJOR LABEL CHANGES Not applicable. 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 ................................................................................ 5 4.1 Dosing Considerations .............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ......................... Přečtěte si celý dokument