מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
5-aminolevulinic acid hydrochloride
Biofrontera Bioscience GmbH
L01XD04
5-aminolevulinic acid hydrochloride
Antineoplastic agents
Keratosis, Actinic; Carcinoma, Basal Cell
Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2; see section 5.1) and of field cancerization in adults.Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.
Revision: 19
Authorised
2011-12-13
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER AMELUZ 78 MG/G GEL 5-aminolaevulinic 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 Ameluz is and what it is used for 2. What you need to know before you use Ameluz 3. How to use Ameluz 4. Possible side effects 5. How to store Ameluz 6. Contents of the pack and other information 1. WHAT AMELUZ IS AND WHAT IT IS USED FOR Ameluz contains the active substance 5-aminolaevulinic acid. It is used to TREAT: • slightly palpable to moderately thick ACTINIC KERATOSES or entire fields affected by actinic keratoses in adults. Actinic keratoses are certain changes in the outer layer of the skin that can lead to skin cancer. • superficial and/or nodular BASAL CELL CARCINOMA unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults. Basal cell carcinoma is a skin cancer that can cause reddish, scaly patches or one or several small bumps that bleed easily and do not heal. After application, the active substance of Ameluz becomes a photoactive substance which accumulates in affected cells. Illumination with appropriate light produces reactive oxygen-containing molecules which act against the target cells. This therapy is known as photodynamic therapy (PDT). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMELUZ DO NOT USE AMELUZ • if you are ALLERGIC to – 5-aminolaevulinic acid or any of the other ingredients of this medicine (listed in section 6) – photoactive substances known as porphyrins – soya קרא את המסמך השלם
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ameluz 78 mg/g gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram (g) gel contains 78 mg of 5-aminolaevulinic acid (as hydrochloride). Excipients with known effect One gram gel contains 2.4 mg sodium benzoate (E211), 3 mg soybean phosphatidylcholine, and 10 mg propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel. White to yellowish gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of actinic keratosis of mild to moderate severity (Olsen grade 1 to 2; see section 5.1) and of field cancerization in adults. Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in adults _For treatment of actinic keratoses (AK) of the face or scalp_ , one session of photodynamic therapy (with natural daylight or a red-light or artificial daylight lamp) shall be administered for single or multiple lesions or entire fields with cancerization (areas of skin where multiple AK lesions are surrounded by an area of actinic and sun-induced damage within a limited field). _For treatment of actinic keratoses (AK) in the body region trunk, neck or extremities, _ one session of narrow-spectrum red-light photodynamic therapy shall be administered. Actinic keratosis lesions or fields shall be evaluated three months after treatment. Treated lesions or fields that have not completely resolved after 3 months shall be retreated. _For treatment of basal cell carcinoma (BCC)_ , two sessions of photodynamic therapy with red-light lamp shall be administered for one or multiple lesions with an interval of about one week between sessions. Basal cell carcinoma lesions shall be evaluated three months after last treatment. Treated lesions that have not completely resolved after 3 months shall be retreated. Paediatric population There is no relevan קרא את המסמך השלם