Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
BRINZOLAMIDE; BRIMONIDINE TARTRATE
NOVARTIS PHARMACEUTICALS CANADA INC
S01EC54
BRINZOLAMIDE, COMBINATIONS
1%; 0.2%
SUSPENSION
BRINZOLAMIDE 1%; BRIMONIDINE TARTRATE 0.2%
OPHTHALMIC
10ML
Prescription
ALPHA-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0256350001; AHFS:
APPROVED
2014-12-11
_SIMBRINZA Brinzolamide/Brimonidine Tartrate _ _Page 1 of 39_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SIMBRINZA ® Brinzolamide/Brimonidine Tartrate Ophthalmic Suspension Suspension, 1%/0.2% w/v, ophthalmic Elevated Intraocular Pressure Therapy Topical Carbonic Anhydrase Inhibitor and Topical Alpha-2 Agonist Agent ATC code S01EC54 Novartis Pharmaceuticals Canada Inc. 385 Bouchard Blvd. Dorval, Quebec H9S 1A9 www.novartis.ca Date of Initial Authorization: DEC 11, 2014 Date of Revision: DEC 23, 2022 Submission Control Number: 266538 SIMBRINZA is a registered trademark. _SIMBRINZA Brinzolamide/Brimonidine Tartrate _ _Page 2 of 39_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS; Hypersensitivity; Renal; Skin 12/2022 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 ........................... Belgenin tamamını okuyun