TEVA-DORZOTIMOL SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

S01ED51

DCI (Dénomination commune internationale):

TIMOLOL, COMBINATIONS

Dosage:

20MG; 5MG

forme pharmaceutique:

SOLUTION

Composition:

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

Mode d'administration:

OPHTHALMIC

Unités en paquet:

5ML/10ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

BETA-ADRENERGIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2018-06-19

Résumé des caractéristiques du produit

Page 1
PRODUCT MONOGRAPH
PR
TEVA-DORZOTIMOL
dorzolamide hydrochloride and timolol maleate
Sterile Ophthalmic Solution
Each mL contains dorzolamide 20 mg and timolol 5 mg
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No.: 143236, 144749
Date of Preparation:
January 24, 2012
Page 2
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
.................................................... 13
PART II: SCIENTIFIC
INFORMATION...............................................................................
14
PHARMACEUTICAL
INFORMATION......................................................................