DUREZOL EMULSION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DIFLUPREDNATE

Pieejams no:

NOVARTIS PHARMACEUTICALS CANADA INC

ATĶ kods:

S01BA

SNN (starptautisko nepatentēto nosaukumu):

CORTICOSTEROIDS, PLAIN

Deva:

0.05%

Zāļu forma:

EMULSION

Kompozīcija:

DIFLUPREDNATE 0.05%

Ievadīšanas:

OPHTHALMIC

Vienības iepakojumā:

5ML

Receptes veids:

Prescription

Ārstniecības joma:

CORTICOSTEROIDS

Produktu pārskats:

Active ingredient group (AIG) number: 0154910001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2013-11-04

Produkta apraksts

_ _
_DUREZOL_
_®_
_ Product Monograph _
_ _
_Page 1 of 42_
PRODUCT MONOGRAPH
Pr
DUREZOL
®
Difluprednate Ophthalmic Emulsion
0.05% w/v
Professed standard
Topical Corticosteroid
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Revision:
July 19, 2018
Submission Control No: 215431
DUREZOL is a registered trademark.
_ _
_DUREZOL_
_®_
_ Product Monograph _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
......................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
................................................