SIMBRINZA SUSPENSION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

BRINZOLAMIDE; BRIMONIDINE TARTRATE

Pieejams no:

NOVARTIS PHARMACEUTICALS CANADA INC

ATĶ kods:

S01EC54

SNN (starptautisko nepatentēto nosaukumu):

BRINZOLAMIDE, COMBINATIONS

Deva:

1%; 0.2%

Zāļu forma:

SUSPENSION

Kompozīcija:

BRINZOLAMIDE 1%; BRIMONIDINE TARTRATE 0.2%

Ievadīšanas:

OPHTHALMIC

Vienības iepakojumā:

10ML

Receptes veids:

Prescription

Ārstniecības joma:

ALPHA-ADRENERGIC AGONISTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2014-12-11

Produkta apraksts

_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
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4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...........................