Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
fluocinolone acetonide, Quantity: 190 microgram
Specialised Therapeutics Alim Pty Ltd
Implant
Excipient Ingredients: polyvinyl alcohol; PMDA/ODA copolymer; dimeticonol; ethyltriacetoxysilane; methyltriacetoxysilane; dibutyltin diacetate; silica dimethicone silylate
Intravitreal-Within The Vitreous Cavity Of The Eye
1 implant in applicator
(S4) Prescription Only Medicine
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).
Visual Identification: Drug core is a light brown filled tube, no visible deformation; Container Type: Carton; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2019-08-06
20190729_ILU_CMI_AU_Cat 1-Approved Page _ _1 of 3 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems. ILUVIEN â _EE–LOO-VEE-UN_ _Fluocinolone Acetonide 190 mcg Intravitreal Implant in Applicator _ CONSUMER MEDICINE INFORMATION JULY 2019 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 Läs hela dokumentet
20190729_ILU_PI_AU_Cat 1- Approved 1 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems. AUSTRALIAN PI – ILUVIEN (FLUOCINOLONE ACETONIDE) INTRAVITREAL IMPLANT IN APPLICATOR 1 NAME OF THE MEDICINE 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 0.19 mg 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). ▼ 20190729_ILU_PI_AU_Cat 1- 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. _Pae Läs hela dokumentet