MYLAN-DORZOLAMIDE/TIMOLOL SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

זמין מ:

MYLAN PHARMACEUTICALS ULC

קוד ATC:

S01ED51

INN (שם בינלאומי):

TIMOLOL, COMBINATIONS

כמות:

20MG; 5MG

טופס פרצבטיות:

SOLUTION

הרכב:

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

מסלול נתינה (של תרופות):

OPHTHALMIC

יחידות באריזה:

10ML

סוג מרשם:

Prescription

איזור תרפויטי:

BETA-ADRENERGIC AGENTS

leaflet_short:

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

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2016-11-02

מאפייני מוצר

_ _
Mylan-Dorzolamide/Timolol_ _
Page 1 of 27
PRODUCT MONOGRAPH
Pr
MYLAN-DORZOLAMIDE/TIMOLOL
Dorzolamide (as Dorzolamide hydrochloride) and Timolol (as Timolol
maleate)
Each mL contains Dorzolamide 20 mg and Timolol 5 mg
Sterile Ophthalmic Solution
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
September 19, 2014
Submission Control No: 177775
_ _
Mylan-Dorzolamide/Timolol_ _
Page 2 of 27
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................................
3
SUMMARY
PRODUCT
INFORMATION
..............................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
....................................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................................
3
WARNINGS
AND
PRECAUTIONS
.......................................................................................................................
4
ADVERSE
REACTIONS
.........................................................................................................................................
7
DOSAGE
AND
ADMINISTRATION....................................................................................................................
10
OVERDOSAGE
.....................................................................................................................................................
10
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
11
STORAGE
AND
STABILITY
...............................................................................................................................
13
DOSAG