Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
5-AMINOLEVULINIC ACID HYDROCHLORIDE
Galderma (UK) Ltd
L01XD04
5-AMINOLEVULINIC ACID HYDROCHLORIDE
8 Milligram
Medicated Plaster
Product subject to prescription which may not be renewed (A)
Sensitizers used in photodynamic/radiation therapy
Transfer Pending
2014-05-16
PACKAGE LEAFLET: INFORMATION FOR THE USER ALACARE 8 MG MEDICATED PLASTER 5-aminolevulinic acid 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 Alacare is and what it is used for 2. What you need to know before you use Alacare 3. How to use Alacare 4. Possible side effects 5. How to store Alacare 6. Contents of the pack and other information 1. WHAT ALACARE IS AND IS AND WHAT IT IS USED FOR Alacare is used for the treatment of mild skin abnormalities on the head or face called solar keratosis. These are small, rough, spots which develop on the skin. They are caused by a lot of exposure to the sun over many years. They are also called actinic keratosis. Treatment with Alacare is a two-step procedure and is called ‚photodynamic therapy’. It consists of Alacare plaster application to the spots for 4 hours. This is followed by illumination with red light for a couple of minutes. Illumination with red light induces a chemical reaction in the cells of the changed skin, which leads to their destruction. The reaction is called ‚phototoxic reaction’. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALACARE Alacare should be applied Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alacare 8 mg medicated plaster 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each medicated plaster of 4 cm² contains 8 mg 5-aminolevulinic acid, 2 mg per cm 2 . For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated plaster. Each plaster has a size of 4 cm², is square with rounded corners and consists of a skin tone backing foil and a self- adhesive matrix, covered by a release liner which is removed prior to use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Single use treatment of mild actinic keratoses with a maximum diameter of 1.8 cm on the face and scalp (hairless areas). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including the elderly)_ For the treatment of AK with one session photodynamic therapy (PDT), apply up to a maximum of six Alacare patches used on six different lesions to the patient on a single treatment session. If the Alacare plaster does not stick to the lesions properly, it can be fixed with an adhesive strip. After four hours, remove the Alacare plaster(s) and expose the lesion(s) to red light with a narrow band red light source with a spectrum of 630 ± 3 nm and a total light dose of 37 J/cm² at the lesion surface. Only CE marked lamps should be used, equipped with necessary filters and/or reflecting mirrors to minimize exposure to heat, blue light and UV radiation. It is important to ensure that the correct light dose is administered. The light dose is determined by factors such as the size of the light field, the distance between lamp and skin surface and illumination time. These factors vary with lamp type, and the lamp should be used according to the user manual. Patient and operator should adhere to safety inst Prečítajte si celý dokument