MYLAN-DORZOLAMIDE/TIMOLOL SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Dostupné s:

MYLAN PHARMACEUTICALS ULC

ATC kód:

S01ED51

INN (Mezinárodní Name):

TIMOLOL, COMBINATIONS

Dávkování:

20MG; 5MG

Léková forma:

SOLUTION

Složení:

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

Podání:

OPHTHALMIC

Jednotky v balení:

10ML

Druh předpisu:

Prescription

Terapeutické oblasti:

BETA-ADRENERGIC AGENTS

Přehled produktů:

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

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2016-11-02

Charakteristika produktu

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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