DORZOLAMIDE EYE DROPS BP SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

可用日期:

HIKMA CANADA LIMITED

ATC代码:

S01EC03

INN（国际名称）:

DORZOLAMIDE

剂量:

2%

药物剂型:

SOLUTION

组成:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

给药途径:

OPHTHALMIC

每包单位数:

100

处方类型:

Prescription

治疗领域:

CARBONIC ANHYDRASE INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0128558001; AHFS:

授权状态:

APPROVED

授权日期:

2022-05-24

产品特点

PRODUCT
MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE EYE DROPS BP
Sterile ophthalmic solution, dorzolamide (as dorzolamide
hydrochloride) 2% weight/volume,
ophthalmic
BP
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9 SUBMISSION CONTROL NO.: 263762
Date of initial authorization:
May 24, 2022
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
TABLE OF CONTENTS
..................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
1
INDICATIONS
......................................................................................................
3
1.1
Pediatrics
.....................................................................................................
3
1.2
Geriatrics
.....................................................................................................
3
2
CONTRAINDICATIONS
.......................................................................................
3
3
DOSAGE AND ADMINISTRATION
.....................................................................
3
3.1
Recommended Dose and Dosage Adjustment
............................................ 3
3.2
Missed Dose
................................................................................................
4
4
OVERDOSAGE
....................................................................................................
4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 4
6
WARNINGS AND PRECAUTIONS
......................................................................
5
6.1
Special Populations
.....................................................................................
6
6.1.1
Pregnant Women
.....................................................................................
6
6.1.2
Breast-feeding
.....................................................