APO-DORZOLAMIDE SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Tilgængelig fra:

APOTEX INC

ATC-kode:

S01EC03

INN (International Name):

DORZOLAMIDE

Dosering:

2%

Lægemiddelform:

SOLUTION

Sammensætning:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

Indgivelsesvej:

OPHTHALMIC

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

CARBONIC ANHYDRASE INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2010-10-25

Produktets egenskaber

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