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
2023-10-25
_DORZOLAMIDE-TIMOLOL PF _ _(Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution)_ Page 1 of 38 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DORZOLAMIDE-TIMOLOL PF Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution (Preservative-Free) Solution, 20 mg/mL dorzolamide (as dorzolamide hydrochloride) and 5 mg/mL timolol (as timolol maleate), Ophthalmic USP Elevated Intraocular Pressure Therapy Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic Blocking Agent Manufactured by: Micro Labs Limited Bangalore– 560001 INDIA Date of Initial Authorization: October 4, 2023 Canadian Importer/Distributor: 13187811 Canada Inc. Mississauga, ON L4Z 1S1 Submission Control Number: 255253 _DORZOLAMIDE-TIMOLOL PF _ _(Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution)_ Page 2 of 38 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 ............................. Læs hele dokumentet