MYLAN-DORZOLAMIDE/TIMOLOL SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

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:

10ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

BETA-ADRENERGIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2016-11-02

Résumé des caractéristiques du produit

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Mylan-Dorzolamide/Timolol_ _
Page 1 of 27
PRODUCT MONOGRAPH
Pr
MYLAN-DORZOLAMIDE/TIMOLOL
Dorzolamide (as Dorzolamide hydrochloride) and Timolol (as Timolol
maleate)
Each mL contains Dorzolamide 20 mg and Timolol 5 mg
Sterile Ophthalmic Solution
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
September 19, 2014
Submission Control No: 177775
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Mylan-Dorzolamide/Timolol_ _
Page 2 of 27
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
DOSAGE
AND
ADMINISTRATION....................................................................................................................
10
OVERDOSAGE
.....................................................................................................................................................
10
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
11
STORAGE
AND
STABILITY
...............................................................................................................................
13
DOSAG