DORZOLAMIDE-TIMOLOL PF SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Fáanlegur frá:

MICRO LABS LIMITED

ATC númer:

S01ED51

INN (Alþjóðlegt nafn):

TIMOLOL, COMBINATIONS

Skammtar:

5MG; 20MG

Lyfjaform:

SOLUTION

Samsetning:

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

Stjórnsýsluleið:

OPHTHALMIC

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-10-25

Vara einkenni

_DORZOLAMIDE-TIMOLOL PF _
_(Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution)_
Page 1 of 38
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE-TIMOLOL PF
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
(Preservative-Free)
Solution, 20 mg/mL dorzolamide (as dorzolamide hydrochloride) and 5
mg/mL timolol (as
timolol maleate), Ophthalmic
USP
Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent
Manufactured by:
Micro Labs Limited
Bangalore– 560001
INDIA
Date of Initial Authorization:
October 4, 2023
Canadian Importer/Distributor:
13187811 Canada Inc.
Mississauga, ON L4Z 1S1
Submission Control Number: 255253
_DORZOLAMIDE-TIMOLOL PF _
_(Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution)_
Page 2 of 38
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
...............................................................................................................
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
.............................