DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Commercializzato da:

BAUSCH & LOMB INC

Codice ATC:

S01ED51

INN (Nome Internazionale):

TIMOLOL, COMBINATIONS

Dosaggio:

5MG; 20MG

Forma farmaceutica:

SOLUTION

Composizione:

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

Via di somministrazione:

OPHTHALMIC

Confezione:

10ML

Tipo di ricetta:

Prescription

Area terapeutica:

BETA-ADRENERGIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-11-01

Scheda tecnica

_Pr_
_D_
_ORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION _
_Product Monograph_ _Page 1 of 36 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
Dorzolamide and timolol eye drops
Solution, 20 mg/mL dorzolamide (as dorzolamide hydrochloride) and 5
mg/mL timolol (as timolol
maleate), Ophthalmic
Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent
Bausch & Lomb Incorporated
Date of Initial Authorization:
1400 North Goodman Street
November 1, 2012
Rochester NY, USA
14609
Date of Revision:
July 14, 2022
Imported and Distributed by:
Bausch + Lomb Corporation
520 Applewood Crescent
Vaughan, Ontario
L4K 4B4
Submission Control Number: 260682
_Pr_
_D_
_ORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION _
_Product Monograph_ _Page 2 of 36 _
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
4.2
Recommended Dose and Do