ACT DORZOTIMOLOL SOLUTION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

থেকে পাওয়া:

TEVA CANADA LIMITED

এটিসি কোড:

S01ED51

INN (আন্তর্জাতিক নাম):

TIMOLOL, COMBINATIONS

ডোজ:

20MG; 5MG

ফার্মাসিউটিকাল ফর্ম:

SOLUTION

রচনা:

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

প্রশাসন রুট:

OPHTHALMIC

প্যাকেজ ইউনিট:

10ML

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

BETA-ADRENERGIC AGENTS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2015-01-07

পণ্য বৈশিষ্ট্য

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
...................