Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)
BAUSCH & LOMB INC
S01ED51
TIMOLOL, COMBINATIONS
5MG; 20MG
SOLUTION
TIMOLOL (TIMOLOL MALEATE) 5MG; DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG
OPHTHALMIC
10ML
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0237301001; AHFS:
APPROVED
2012-11-01
_Pr_ _D_ _ORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION _ _Product Monograph_ _Page 1 of 36 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION Dorzolamide and timolol eye drops Solution, 20 mg/mL dorzolamide (as dorzolamide hydrochloride) and 5 mg/mL timolol (as timolol maleate), Ophthalmic Elevated Intraocular Pressure Therapy Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic Blocking Agent Bausch & Lomb Incorporated Date of Initial Authorization: 1400 North Goodman Street November 1, 2012 Rochester NY, USA 14609 Date of Revision: July 14, 2022 Imported and Distributed by: Bausch + Lomb Corporation 520 Applewood Crescent Vaughan, Ontario L4K 4B4 Submission Control Number: 260682 _Pr_ _D_ _ORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION _ _Product Monograph_ _Page 2 of 36 _ RECENT MAJOR LABEL CHANGES Not applicable. TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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 Do Izlasiet visu dokumentu