DORZOLAMIDE-TIMOLOL SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Fáanlegur frá:

JAMP PHARMA CORPORATION

ATC númer:

S01ED51

INN (Alþjóðlegt nafn):

TIMOLOL, COMBINATIONS

Skammtar:

20MG; 5MG

Lyfjaform:

SOLUTION

Samsetning:

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

Stjórnsýsluleið:

OPHTHALMIC

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

BETA-ADRENERGIC AGENTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-11-04

Vara einkenni

_Dorzolamide-Timolol_
_ _
_(Dorzolamide Hydrochloride and Timolol Maleate) _
_Page 1 of 35 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE-TIMOLOL
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
Solution, 20 mg / mL Dorzolamide (as Dorzolamide Hydrochloride) and 5
mg / mL Timolol
(as Timolol Maleate), Ophthalmic
Manufacturer’s Standard
Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
October 28, 2021
Date of Revision:
December 30, 2022
Submission Control Number: 266282
_Dorzolamide-Timolol_
_ _
_(Dorzolamide Hydrochloride and Timolol Maleate) _
_Page 2 of 35 _
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
..............................................................................4
4.1
Dosing Considerations
....................................................................................4
4.2
Recommended Dose and Dosage Adjustment
......