ACT DORZOTIMOLOL SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

から入手可能:

TEVA CANADA LIMITED

ATCコード:

S01ED51

INN（国際名）:

TIMOLOL, COMBINATIONS

投薬量:

20MG; 5MG

医薬品形態:

SOLUTION

構図:

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

投与経路:

OPHTHALMIC

パッケージ内のユニット:

10ML

処方タイプ:

Prescription

治療領域:

BETA-ADRENERGIC AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2015-01-07

製品の特徴

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