Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUOCINOLONE ACETONIDE
Alimera Sciences Limited
S01BA15
FLUOCINOLONE ACETONIDE
190 Microgram
Product subject to prescription which may not be renewed (A)
fluocinolone acetonide
Marketed
2014-11-07
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 Read the complete document
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, 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 injections. The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include use Read the complete document