DORZOLAMIDE SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

から入手可能:

ALCON CANADA INC

ATCコード:

S01EC03

INN（国際名）:

DORZOLAMIDE

投薬量:

2.0%

医薬品形態:

SOLUTION

構図:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2.0%

投与経路:

OPHTHALMIC

パッケージ内のユニット:

5ML/10ML

処方タイプ:

Prescription

治療領域:

CARBONIC ANHYDRASE INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0128558001; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2017-07-17

製品の特徴

_Product Monograph –Dorzolamide Hydrochloride ophthalmic solution
Page 1 of 18 _
PRODUCT MONOGRAPH
PR
DORZOLAMIDE
Dorzolamide (as Dorzolamide Hydrochloride USP) 2.0% w/v
Sterile Ophthalmic Solution
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
Alcon Canada Inc.
2665 Meadowpine Blvd.
Mississauga, ON
L5N 8C7
www.Alcon.ca
Date of Preparation:
March 2, 2011
Submission Control No: 129533
_Product Monograph –Dorzolamide Hydrochloride ophthalmic solution
Page 2 of 18 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................
3
ADVERSE REACTIONS
.....................................................................................................
5
DRUG INTERACTIONS
.....................................................................................................
6
DOSAGE AND ADMINISTRATION
................................................................................
7
OVERDOSAGE
....................................................................................................................
7
ACTION AND CLINICAL PHARMOCOLOGY
............................................................. 8
STORAGE AND STABILITY
.............................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 9
PART II: SCIENTIFIC INFORMATION
...............................................................................
10
PHARMACEUTICAL INFORMATION
.........................................................