ACT DORZOTIMOLOL SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

זמין מ:

TEVA CANADA LIMITED

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:

APPROVED

תאריך אישור:

2015-01-07

מאפייני מוצר

ACT DORZOTIMOLOL_ _
_Page 1 of 29_
PRODUCT MONOGRAPH
PR
ACT DORZOTIMOLOL
Dorzolamide and timolol ophthalmic solution
20 mg/ml, 5 mg/ml
(as dorzolamide hydrochloride and timolol maleate)
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision:
April 18, 2018
Submission Control No.: 214649
ACT DORZOTIMOLOL
_ _
_Page 2 of 29_
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
DRUG INTERACTIONS
..................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
..............................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
...................