AZOPT SUSPENSION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

BRINZOLAMIDE

Доступно од:

NOVARTIS PHARMACEUTICALS CANADA INC

АТЦ код:

S01EC04

INN (Међународно име):

BRINZOLAMIDE

Дозирање:

1%

Фармацеутски облик:

SUSPENSION

Састав:

BRINZOLAMIDE 1%

Пут администрације:

OPHTHALMIC

Јединице у пакету:

5ML

Тип рецептора:

Prescription

Терапеутска област:

CARBONIC ANHYDRASE INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0134800001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2017-02-16

Карактеристике производа

_AZOPT (Brinzolamide) _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AZOPT
®
Brinzolamide Ophthalmic Suspension
Suspension, 1% w/v, ophthalmic
Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor
ATC code S01EC04
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Initial Authorization:
OCT 23, 1998
Date of Revision:
Feb 9, 2023
Submission Control Number: 266542
AZOPT is a registered trademark.
_AZOPT (Brinzolamide) _
_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS; Hypersensitivity; Skin
01/2023
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..................................................... 5
4.4
Administration...................................................................................................