DORZOLAMIDE-TIMOLOL PF SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

זמין מ:

MICRO LABS LIMITED

קוד ATC:

S01ED51

INN (שם בינלאומי):

TIMOLOL, COMBINATIONS

כמות:

5MG; 20MG

טופס פרצבטיות:

SOLUTION

הרכב:

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

מסלול נתינה (של תרופות):

OPHTHALMIC

יחידות באריזה:

100

סוג מרשם:

Prescription

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2023-10-25

מאפייני מוצר

_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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