MED-DORZOLAMIDE SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Dostopno od:

GENERIC MEDICAL PARTNERS INC

Koda artikla:

S01EC03

INN (mednarodno ime):

DORZOLAMIDE

Odmerek:

2%

Farmacevtska oblika:

SOLUTION

Sestava:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

Pot uporabe:

OPHTHALMIC

Enote v paketu:

5ML FILL VOLUME

Tip zastaranja:

Prescription

Terapevtsko območje:

CARBONIC ANHYDRASE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2016-08-31

Lastnosti izdelka

_MED-DORZOLAMIDE_
_ _
_(dorzolamide hydrochloride) _
_Page 1 of 28 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MED-DORZOLAMIDE
Dorzolamide Eye Drops
Solution, dorzolamide 2% weight/volume, Ophthalmic
B.P.
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
Generic Medical Partners Inc.
1500 Don Mills Road, Suite 711
Toronto, Ontario,
M3B 3K4
Date of Initial Authorization:
August 29, 2016
Date of Revision:
July 28, 2023
Submission Control Number: 272250
_MED-DORZOLAMIDE_
_ _
_(dorzolamide hydrochloride) _
_Page 2 of 28 _
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
...............................................................................................