SANDOZ DORZOLAMIDE SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Boleh didapati daripada:

SANDOZ CANADA INCORPORATED

Kod ATC:

S01EC03

INN (Nama Antarabangsa):

DORZOLAMIDE

Dos:

2%

Borang farmaseutikal:

SOLUTION

Komposisi:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

Laluan pentadbiran:

OPHTHALMIC

Unit dalam pakej:

5ML/10ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CARBONIC ANHYDRASE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2012-02-03

Ciri produk

_Sandoz Dorzolamide Page 1 of 18 _
PRODUCT MONOGRAPH
P
R
SANDOZ DORZOLAMIDE
2% Dorzolamide (as Dorzolamide Hydrochloride USP)
Sterile Ophthalmic Solution
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
Sandoz Canada Inc.
145 Jules-Leger
Date of Preparation: January 31, 2012
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 152463
_Sandoz Dorzolamide 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..................................................................................4
ADVERSE
REACTIONS....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND
ADMINISTRATION................................................................................7
OVERDOSAGE
..................................................................................................................7
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND
STABILITY............................................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................9
PART II: SCIENTIFIC INFORMATION
...............................................................................10
PHARMACEUTICAL
INFORMATION..........................................................................10
CLINICAL
TRIALS.......................................................................................