COSOPT SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Tilgjengelig fra:

ELVIUM LIFE SCIENCES

ATC-kode:

S01ED51

INN (International Name):

TIMOLOL, COMBINATIONS

Dosering :

5MG; 20MG

Legemiddelform:

SOLUTION

Sammensetning:

TIMOLOL (TIMOLOL MALEATE) 5MG; DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG

Administreringsrute:

OPHTHALMIC

Enheter i pakken:

10ML

Resept typen:

Prescription

Terapeutisk område:

BETA-ADRENERGIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0237301001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2005-06-02

Preparatomtale

_COSOPT_
_®_
_ (dorzolamide hydrochloride and timolol maleate) _
_Page 1 of 37 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
COSOPT®
PR
COSOPT® PRESERVATIVE-FREE
Dorzolamide and Timolol Ophthalmic Solution
Solution, 20 mg/mL dorzolamide hydrochloride and 5 mg/mL timolol
maleate
Ophthalmic Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent
Elvium Life Sciences
3381 Steeles Avenue East, Suite 310
Toronto, ON
M2H 3S7
Date of Initial Authorization:
OCT 25, 2016
Date of Revision:
NOV 28, 2023
Submission Control Number: 274763
COSOPT® is a trademark of Elvium Life Sciences
_ _
_COSOPT_
_®_
_ (dorzolamide hydrochloride and timolol maleate) _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
DOSAGE AND ADMINISTRATION, 4.4
Administration
11/2023
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
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4