Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
afamelanotide
Clinuvel Europe Limited
D02BB02
afamelanotide
Emollients and protectives
Protoporphyria, Erythropoietic
Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Revision: 9
Authorised
2014-12-22
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SCENESSE 16 MG IMPLANT afamelanotide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 SCENESSE is and what it is used for 2. What you need to know before you receive SCENESSE 3. How SCENESSE is given 4. Possible side effects 5. How SCENESSE is stored 6. Contents of the pack and other information 1. WHAT SCENESSE IS AND WHAT IT IS USED FOR SCENESSE contains the active substance afamelanotide (as acetate). Afamelanotide is a synthetic form of a body hormone called alpha-melanocyte stimulating hormone (α-MSH). Afamelanotide works in a way similar to the natural hormone, by making skin cells produce eumelanin which is a brown-black type of melanin pigment in the body. Afamelanotide is used to increase the tolerance to sunlight in adults with a confirmed diagnosis of erythropoietic protoporphyria (EPP). EPP is a condition in which patients have an increased sensitivity to sunlight, which can cause toxic effects such as pain and burning. By increasing the amount of eumelanin, SCENESSE can help to delay the onset of pain due to skin photosensitivity (sensitive to sunlight). 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE SCENESSE DO NOT USE SCENESSE - if you are allergic to afamelanotide or any of the other ingredients of this medicine (listed in section 6). - if you have any severe condition of the liver. - if you have liver problems. - if you have kidney problems. WARNINGS AND PRECAUTIONS Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT SCENESSE 16 mg implant 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The implant contains 16 mg of afamelanotide (as acetate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Implant. Solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SCENESSE is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION SCENESSE should only be prescribed by specialist physicians in recognised porphyria centres and administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant. _ _ Posology One implant is administered every 2 months prior to expected and during increased sunlight exposure, e.g. from spring to early autumn. Three implants per year are recommended, depending on the length of protection required. The recommended maximum number of implants is four per year. The overall duration of treatment is at the specialist physician’s discretion (see section 4.4). Special populations For patients with renal or hepatic impairment see sections 4.3 and 5.2. _Elderly population _ Due to limited data in treatment of elderly patients, the use of afamelanotide is not recommended (see section 4.4). _Paediatric population _ The safety and efficacy of afamelanotide in children and adolescents aged 0 to 17 years have not yet been established. No data are available. 3 Method of administration _ _ For subcutaneous use. Instruction for use _ _ - Take the packed implant out of the refrigerator and allow the medicinal product to warm up to ambient temp Lue koko asiakirja