MED-DORZOLAMIDE-TIMOLOL SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

متاح من:

GENERIC MEDICAL PARTNERS INC

ATC رمز:

S01ED51

INN (الاسم الدولي):

TIMOLOL, COMBINATIONS

جرعة:

20MG; 5MG

الشكل الصيدلاني:

SOLUTION

تركيب:

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

طريقة التعاطي:

OPHTHALMIC

الوحدات في الحزمة:

10ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

BETA-ADRENERGIC AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2015-02-19

خصائص المنتج

_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
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4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.....................................