ILUVIEN IMPLANT

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FLUOCINOLONE ACETONIDE

Disponible depuis:

KNIGHT THERAPEUTICS INC.

Code ATC:

S01BA15

DCI (Dénomination commune internationale):

FLUOCINOLONE ACETONIDE

Dosage:

0.19MG

forme pharmaceutique:

IMPLANT

Composition:

FLUOCINOLONE ACETONIDE 0.19MG

Mode d'administration:

INTRAVITREAL

Unités en paquet:

1

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CORTICOSTEROIDS

Descriptif du produit:

Active ingredient group (AIG) number: 0106314004; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2021-12-22

Résumé des caractéristiques du produit

_ILUVIEN (fluocinolone acetonide) - Product Monograph _
_Page 1 of 28_
PRODUCT MONOGRAPH
PR
ILUVIEN
®
Fluocinolone acetonide
Intravitreal implant, 0.19 mg
Corticosteroid
Knight Therapeutics Inc.
3400 De Maisonneuve Blvd. W., Suite 1055
Montreal, Quebec, Canada, H3Z 3B8
Date of Revision:
July 3, 2019
_ _
Submission Control No: 226424
_ _
_ILUVIEN (fluocinolone acetonide)- Product Monograph _
_Page 2 of 28 _
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................15
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL INFORMATION
.................................................................