Страна: Канада
мова: англійська
Джерело: Health Canada
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)
MICRO LABS LIMITED
S01EC03
DORZOLAMIDE
2%
SOLUTION
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%
OPHTHALMIC
100
Prescription
Active ingredient group (AIG) number: 0128558001; AHFS:
APPROVED
2023-10-31
_DORZOLAMIDE PF (Dorzolamide Hydrochloride Ophthalmic Solution) _ _Page 1 of 29 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DORZOLAMIDE PF Dorzolamide Hydrochloride Ophthalmic Solution (Preservative-Free) Solution, 2% weight/volume Dorzolamide (as Dorzolamide hydrochloride), Ophthalmic House Standard Elevated Intraocular Pressure Therapy (Topical Carbonic Anhydrase Inhibitor) Manufactured by: Micro Labs Limited Bangalore– 560001 INDIA Date of Initial Authorization: October 5, 2023 Canadian Importer/Distributor: 13187811 Canada Inc. Mississauga, ON L4Z 1S1 Submission Control Number: 255546 _DORZOLAMIDE PF (Dorzolamide Hydrochloride Ophthalmic Solution) _ _Page 2 of 29 _ 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 ................................... Прочитайте повний документ