MED-DORZOLAMIDE-TIMOLOL SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Sẵn có từ:

GENERIC MEDICAL PARTNERS INC

Mã ATC:

S01ED51

INN (Tên quốc tế):

TIMOLOL, COMBINATIONS

Liều dùng:

20MG; 5MG

Dạng dược phẩm:

SOLUTION

Thành phần:

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

Tuyến hành chính:

OPHTHALMIC

Các đơn vị trong gói:

10ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

BETA-ADRENERGIC AGENTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2015-02-19

Đặc tính sản phẩm

_MED-DORZOLAMIDE-TIMOLOL_
_ _
_(dorzolamide hydrochloride and timolol maleate) _
_Page 1 of 36 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MED-DORZOLAMIDE-TIMOLOL
Dorzolamide and Timolol Ophthalmic Solution
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
Generic Medical Partners Inc.
1500 Don Mills Road, Suite 711
Toronto, Ontario, M3B 3K4
Date of Initial Authorization:
FEB 27, 2015
Date of Revision:
Dec 30, 2022
Submission Control Number: 269684
_MED-DORZOLAMIDE-TIMOLOL_
_ _
_(dorzolamide hydrochloride and timolol maleate) _
_Page 2 of 36 _
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
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.....................................