SIMBRINZA SUSPENSION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

BRINZOLAMIDE; BRIMONIDINE TARTRATE

Доступно од:

NOVARTIS PHARMACEUTICALS CANADA INC

АТЦ код:

S01EC54

INN (Међународно име):

BRINZOLAMIDE, COMBINATIONS

Дозирање:

1%; 0.2%

Фармацеутски облик:

SUSPENSION

Састав:

BRINZOLAMIDE 1%; BRIMONIDINE TARTRATE 0.2%

Пут администрације:

OPHTHALMIC

Јединице у пакету:

10ML

Тип рецептора:

Prescription

Терапеутска област:

ALPHA-ADRENERGIC AGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0256350001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2014-12-11

Карактеристике производа

_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
...........................