DORZOLAMIDE SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Διαθέσιμο από:

ALCON CANADA INC

Φαρμακολογική κατηγορία (ATC):

S01EC03

INN (Διεθνής Όνομα):

DORZOLAMIDE

Δοσολογία:

2.0%

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2.0%

Οδός χορήγησης:

OPHTHALMIC

Μονάδες σε πακέτο:

5ML/10ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CARBONIC ANHYDRASE INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2017-07-17

Αρχείο Π.Χ.Π.

_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
.........................................................