ILUVIEN 190microgram intravitreal implant in applicator

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluocinolone acetonide

Available from:

Alimera Sciences Ltd

ATC code:

S01BA15

INN (International Name):

Fluocinolone acetonide

Dosage:

190microgram

Pharmaceutical form:

Prolonged-release intravitreal implant

Administration route:

Intravitreal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11040100; GTIN: 00368611000032

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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ILUVIEN
YOU MUST NOT RECEIVE ILUVIEN:
-
If you are allergic (hypersensitive) to fluocinolone acetonide or any
of the other
ingredients of this medicine (listed in section 6).
-
If you have an infection of any kind in or around your eye.
-
If you have glaucoma (high pressure inside your eye).
WARNINGS AND PRECAUTIONS
-
Before your ILUVIEN injection tell your doctor if:
•
You are taking any medicines to thin the blood
•
Y

Summary of Product characteristics

OBJECT 1
ILUVIEN 190 MICROGRAMS INTRAVITREAL IMPLANT IN
APPLICATOR
Summary of Product Characteristics Updated 09-Nov-2015 | Alimera
Sciences Limited
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, considered insufficiently responsive to available therapies
(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. 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.
_Paediatric population_
There is no relevant use of intravitreally administered fluocinolone
acetonide in the paediatric population
in diabetic macular oedema (DMO).
_Special populations_
No dosage adjustments are necessary in elderly patients, or those with
renal or hepatic impairment.
Method of administration
FOR INTRAVITREAL USE ONLY.
Treatment with ILUVIEN is for intravitreal use only and should be
administered by an ophthalmologist
experienced in intravitreal injecti