APO-DORZOLAMIDE SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Verfügbar ab:

APOTEX INC

ATC-Code:

S01EC03

INN (Internationale Bezeichnung):

DORZOLAMIDE

Dosierung:

2%

Darreichungsform:

SOLUTION

Zusammensetzung:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

Verabreichungsweg:

OPHTHALMIC

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

CARBONIC ANHYDRASE INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2010-10-25

Fachinformation

PRODUCT MONOGRAPH
APO-DORZOLAMIDE
DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION
DORZOLAMIDE 2% WEIGHT/VOLUME
STERILE OPHTHALMIC SOLUTION
ELEVATED INTRAOCULAR PRESSURE THERAPY
(TOPICAL CARBONIC ANHYDRASE INHIBITOR)
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
OCTOBER 25, 2010
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER:
107589, 141578
_____________________________________________________________________________________________
_APO-DORZOLAMIDE Product Monograph _
_ _
_Page 2 of 20_
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
....................................................................................
6
DRUG
INTERACTIONS.....................................................................................
7
DOSAGE AND
ADMINISTRATION.................................................................
8
OVERDOSAGE
...................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
...............................................
9
STORAGE AND
STABILITY.............................................................................
10
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................
10
PART II: SCIENTIFIC INFORMATION
..................................................................
11
PHARMACEUTICAL INFORMATION
............................................................
11
CLINICAL
TRIALS.............................................................................................
11
DETAILED
PHARMACOLOGY........................................................................
13
T