DORZOLAMIDE-TIMOLOL SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

제공처:

MICRO LABS LIMITED

ATC 코드:

S01ED51

INN (International Name):

TIMOLOL, COMBINATIONS

복용량:

5MG; 20MG

약제 형태:

SOLUTION

구성:

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

관리 경로:

OPHTHALMIC

패키지 단위:

100

처방전 유형:

Prescription

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2022-06-23

제품 특성 요약

_Page 1 of 37_
_DORZOLAMIDE-TIMOLOL (Dorzolamide Hydrochloride and Timolol Maleate
Ophthalmic Solution)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE-TIMOLOL
Dorzolamide
Hydrochloride and Timolol Maleate Ophthalmic Solution
Ophthalmic Solution, 20 mg / mL dorzolamide (as dorzolamide
hydrochloride) and 5 mg / mL
timolol (as timolol maleate)
USP
Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent
Manufactured by:
Date of Initial Approval:
Micro Labs Limited
June 16, 2022
Bangalore– 560001
INDIA
Canadian Importer/Distributor:
13187811
Canada Inc.
Mississauga, ON L4Z 1S1
Submission Control Number: 250138
_Page 2 of 37_
_DORZOLAMIDE-TIMOLOL (Dorzolamide Hydrochloride and Timolol Maleate
Ophthalmic Solution)_
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
.............