Land: Canada
Sprog: engelsk
Kilde: Health Canada
TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)
MICRO LABS LIMITED
S01ED51
TIMOLOL, COMBINATIONS
5MG; 20MG
SOLUTION
TIMOLOL (TIMOLOL MALEATE) 5MG; DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG
OPHTHALMIC
100
Prescription
Active ingredient group (AIG) number: 0237301001; AHFS:
APPROVED
2022-06-23
_Page 1 of 37_ _DORZOLAMIDE-TIMOLOL (Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution)_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DORZOLAMIDE-TIMOLOL Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution Ophthalmic Solution, 20 mg / mL dorzolamide (as dorzolamide hydrochloride) and 5 mg / mL timolol (as timolol maleate) USP Elevated Intraocular Pressure Therapy Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic Blocking Agent Manufactured by: Date of Initial Approval: Micro Labs Limited June 16, 2022 Bangalore– 560001 INDIA Canadian Importer/Distributor: 13187811 Canada Inc. Mississauga, ON L4Z 1S1 Submission Control Number: 250138 _Page 2 of 37_ _DORZOLAMIDE-TIMOLOL (Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution)_ 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 ............. Læs hele dokumentet