OZURDEX IMPLANT

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

DEXAMETHASONE

Beszerezhető a:

ABBVIE CORPORATION

ATC-kód:

S01BA01

INN (nemzetközi neve):

DEXAMETHASONE

Adagolás:

0.7MG

Gyógyszerészeti forma:

IMPLANT

Összetétel:

DEXAMETHASONE 0.7MG

Az alkalmazás módja:

INTRAVITREAL

db csomag:

1 APPLICATOR

Recept típusa:

Prescription

Terápiás terület:

CORTICOSTEROIDS

Termék összefoglaló:

Active ingredient group (AIG) number: 0106303011; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2011-02-10

Termékjellemzők

_OZURDEX_
®
_(dexamethasone intravitreal implant) _
_Page 1 of 39 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
OZURDEX®
Dexamethasone Intravitreal Implant
Implant, 0.7 mg, for intravitreal injection
Corticosteroid
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Initial Authorization:
FEB 10, 2011
Date of Revision:
DEC 12, 2023
Submission Control Number: 277147
_OZURDEX_
®
_(dexamethasone intravitreal implant) _
_Page 2 of 39 _
_ _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
12/2023
7 WARNINGS AND PRECAUTIONS
12/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1 Pediatrics (< 18 years of age)
......................................................................................
4
1.2 Geriatrics (> 65 years of age)
......................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1 Dosing Considerations
................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
........................................................... 5
4.4 Administration
............................................................................................................
5
4.5 Missed Dose
........