ILUVIEN 190 micrograms intravitreal implant in applicator

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluocinolone acetonide

Available from:

Alimera Sciences Europe Limited,

ATC code:

S01BA15

INN (International Name):

Fluocinolone acetonide

Dosage:

190 microgram(s)

Pharmaceutical form:

Intravitreal implant in applicator

Therapeutic area:

fluocinolone acetonide

Authorization status:

Marketed

Authorization date:

2014-11-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ILUVIEN 190 MICROGRAMS INTRAVITREAL IMPLANT IN APPLICATOR
(fluocinolone acetonide)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What ILUVIEN is and what it is used for
2. What you need to know before you are given ILUVIEN
3. How ILUVIEN is administered
4. Possible side effects
5. How to store ILUVIEN
6. Contents of the pack and other information
1.
WHAT ILUVIEN IS AND WHAT IT IS USED FOR
ILUVIEN is a tiny tube that is inserted into the eye and releases very
small amounts of the active
ingredient, fluocinolone acetonide, for up to 3 years. Fluocinolone
acetonide belongs to a group of
medicines called corticosteroids.
ILUVIEN is used to treat vision loss associated with diabetic macular
oedema when other available
treatments have failed to help. Diabetic macular oedema is a condition
that affects some people with
diabetes and causes damage to the light-sensitive layer at the back of
the eye responsible for central
vision, the macula. The active ingredient (the drug fluocinolone
acetonide) helps to reduce the
inflammation and the swelling that builds up in the macula in this
condition. ILUVIEN can therefore
help to improve the damaged vision or stop it from getting worse.
ILUVIEN is used to prevent relapses of inflammation of the back of the
eye. This inflammation can
cause floaters which are black dots or wispy lines that move across
what you can see (‘field of vision’)
or can cause loss of vision by damaging the part of the eye
responsible for good vision, called the
‘macula’. The loss of vision may not improve unless the
inflammation is treated. ILUVIEN helps to
reduce the inflammation and the swelling that it can cause in the

Summary of Product characteristics

Health Products Regulatory Authority
04 September 2023
CRN00DM39
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ILUVIEN 190 micrograms intravitreal implant in applicator
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implant contains 190 micrograms of fluocinolone acetonide.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Intravitreal implant in applicator.
Light brown coloured cylinder, approximately 3.5mm x 0.37mm in size.
Implant applicator with 25 gauge needle.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ILUVIEN is indicated for the treatment of vision impairment associated
with chronic diabetic macular oedema, (DMO)
considered insufficiently responsive to available therapies (see
Section 5.1).
ILUVIEN is indicated for prevention of relapse in recurrent
non-infectious uveitis affecting the posterior segment of the eye (see
Section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one ILUVIEN implant in the affected eye.
Administration in both eyes concurrently is not
recommended (see Section 4.4).
Each ILUVIEN implant releases fluocinolone acetonide for up to 36
months.
_Diabetic Macular Oedema _
An additional implant may be administered after 12 months if the
patient experiences decreased vision or an increase in retinal
thickness secondary to recurrent or worsening diabetic macular oedema
(see Section 5.1).
Retreatments should not be administered unless the potential benefits
outweigh the risks.
Only patients who have been insufficiently responsive to prior
treatment with laser photocoagulation or other available
therapies for diabetic macular oedema should be treated with ILUVIEN.
_Non-Infectious Uveitis affecting the Posterior Segment_
There are no data available to support the retreatment of patients
with an additional implant when used for the prevention of
relapse in recurrent non-infectious uveitis affecting the posterior
segment of the eye.
_ _
_Paediatric population_
_ _
There is no relevant use of intravit