Pajjiż: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Fluocinolone acetonide 190ug
Specialised Therapeutics Limited
190 mcg
Intraocular implant
Active: Fluocinolone acetonide 190ug Excipient: MED-1137 RTV Silicone Adhesive Polyvinyl alcohol Pyromellitic dianhydride, 4,4'-oxydianiline polymer
Prescription
For the treatment of diabetic macular oedema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).
Package - Contents - Shelf Life: Applicator, pre-filled, single dose, thermoform tray and tyvek lid in carton. - 1 dose units - 2 years from date of manufacture stored at or below 25°C. Do not refrigerate, do not freeze.
2020-10-02
20220609_ILU_CMI_NZ_aNMA_approved Page _ _1 of 3 ILUVIEN â (ee–loo-vee-un) Fluocinolone Acetonide 190 mcg Intravitreal Implant in Applicator CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Iluvien. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of your taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ILUVIEN 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 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT RECEIVE _ _IT _ YOU MUST NOT BE GIVEN ILUVIEN: • If you are allergic (hypersensitive) to fluocinolone acetonide or any of the other ingredients of Iluvien listed at the end of this leaflet (see PRODUCT DESCRIPTION ). Some of the symptoms of an allergic reaction may include: - shortness of breath Aqra d-dokument sħiħ
20220609_ILU_DS_NZ_aNMA_draft_approved 1 NEW ZEALAND DATASHEET ILUVIEN ® (FLUOCINOLONE ACETONIDE) 1 PRODUCT NAME ILUVIEN _fluocinolone acetonide_ 190 micrograms intravitreal implant in applicator. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ILUVIEN ® is a non-biodegradable intravitreal implant in a drug delivery system containing 190 micrograms fluocinolone acetonide, designed to release fluocinolone acetonide for 36 months. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ILUVIEN is a sterile non-bioerodable intravitreal implant which is inside a single use applicator with a 25 gauge needle. The implant is a light brown colour and cylindrical in shape with dimensions 3.5 mm long x 0.37 mm in diameter. The applicator is packaged in a plastic tray sealed with a lid. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ILUVIEN is indicated for the treatment of diabetic macular oedema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). 4.2 D OSE AND METHOD OF ADMINISTRATION For ophthalmic intravitreal injection. The recommended dose is one ILUVIEN implant in the affected eye. Administration in both eyes concurrently has not been studied and is not recommended (see Section 4.4 Special warnings and precautions for use). 20220609_ILU_DS_NZ_aNMA_draft_approved 2 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 Pharmacodynamic properties). Retreatments should not be administered unless the potential benefits outweigh the risks. _Paediatric Population _ There is no relevant use of intravitreally administered fluocinolone acetonide in the paediatric population in diabetic macular oedema (DME). The safety and efficacy of fluocinolone acetonide in the paediatric population has not been established. _Special Popul Aqra d-dokument sħiħ