DORZOLAMIDE-TIMOLOL SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

MAH:

ALCON CANADA INC

ATC_code:

S01ED51

INN:

TIMOLOL, COMBINATIONS

dosage:

2.0%; 0.5%

pharmaceutical_form:

SOLUTION

composition:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2.0%; TIMOLOL (TIMOLOL MALEATE) 0.5%

administration_route:

OPHTHALMIC

units_in_package:

5ML/10ML

prescription_type:

Prescription

therapeutic_area:

BETA-ADRENERGIC AGENTS

leaflet_short:

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

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2021-06-25

SPC

_Product Monograph – _
_ _
_Page 1 of 28_
_ _
_DORZOLAMIDE-TIMOLOL _
_ _
PRODUCT MONOGRAPH
PR
DORZOLAMIDE-TIMOLOL
Dorzolamide (as Dorzolamide Hydrochloride USP) 2.0% and
Timolol (as Timolol Maleate USP) 0.5% w/v
Sterile Ophthalmic Solution
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Alcon Canada Inc.
2665 Meadowpine Blvd.
Mississauga, ON
L5N 8C7
Date of Preparation:
October 1, 2010
SUBMISSION CONTROL NO: 131041
_Product Monograph – _
_ _
_Page 2 of 28_
_ _
_DORZOLAMIDE-TIMOLOL _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..................................................... 3
SUMMARY PRODUCT
INFORMATION.........................................................................
3
INDICATIONS AND CLINICAL
USE...............................................................................
3
CONTRAINDICATIONS
.....................................................................................................
3
WARNINGS AND PRECAUTIONS
...................................................................................
4
ADVERSE
REACTIONS......................................................................................................
7
DRUG
INTERACTIONS......................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
10
OVERDOSAGE
...................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND
STABILITY............................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
...........................................................................
15
PHARMACEUTICAL
INFORMATIO