DORZOLAMIDE AND TIMOLOL EYE DROPS BP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Disponibil de la:

HIKMA CANADA LIMITED

Codul ATC:

S01ED51

INN (nume internaţional):

TIMOLOL, COMBINATIONS

Dozare:

20MG; 5MG

Forma farmaceutică:

SOLUTION

Compoziție:

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

Calea de administrare:

OPHTHALMIC

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

BETA-ADRENERGIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2019-07-11

Caracteristicilor produsului

_DORZOLAMIDE AND TIMOLOL EYE DROPS BP_
_ _
_(dorzolamide hydrochloride and timolol maleate) _
_Page 1 of 37_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE AND TIMOLOL EYE DROPS BP
Solution, 20 mg/mL dorzolamide hydrochloride and 5 mg/mL timolol
maleate, Ophthalmic
BP
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Date of Initial Authorization:
MAY 24, 2022
Date of Revision:
APR 6, 2023
Submission Control Number: 273317
_DORZOLAMIDE AND TIMOLOL EYE DROPS BP_
_ _
_(dorzolamide hydrochloride and timolol maleate) _
_Page 2 of 37_
_ _
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
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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 Dosage Adjustment
.........................