Pays: Canada
Langue: anglais
Source: Health Canada
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)
JAMP PHARMA CORPORATION
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
2021-11-04
_Dorzolamide-Timolol_ _ _ _(Dorzolamide Hydrochloride and Timolol Maleate) _ _Page 1 of 35 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DORZOLAMIDE-TIMOLOL Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution Solution, 20 mg / mL Dorzolamide (as Dorzolamide Hydrochloride) and 5 mg / mL Timolol (as Timolol Maleate), Ophthalmic Manufacturer’s Standard Elevated Intraocular Pressure Therapy Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic Blocking Agent JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: October 28, 2021 Date of Revision: December 30, 2022 Submission Control Number: 266282 _Dorzolamide-Timolol_ _ _ _(Dorzolamide Hydrochloride and Timolol Maleate) _ _Page 2 of 35 _ 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 ..............................................................................4 4.1 Dosing Considerations ....................................................................................4 4.2 Recommended Dose and Dosage Adjustment ...... Lire le document complet