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hours after application of Ameluz®.Special warnings and
expected as the therapeutic principle of photodynamic Ameluz® 78 mg/g gel. Active pharmaceutical ingredient:
precautions (please see SPC for further detail): No
therapy is based on phototoxic effects of protoporphyrin IX 5-aminolaevulinic acid (as hydrochloride). Please refer to experience exists for the use of Ameluz® in patients with
which is synthesized from the active ingredient 5- aminolaevulinic acid. The most common signs and Presentation: 1g gel contains 78 mg 5-aminolaevulinic
immunosuppressed patients. There is no experience of symptoms are application site irritation, erythema, pain, acid (as hydrochloride). Indication: Treatment of actinic
treating actinic keratosis lesions in patients with dark and oedema. The intensity of these effects is dependent keratosis of mild to moderate intensity on the face and brown or black skin (skin sun sensitivity type V or VI on the type of illumination used for photodynamic therapy. scalp (Olsen grade 1 to 2; see SPC for further detail) Dose
according to Fitzpatrick). The success and assessment of The increased effects correlate with the higher clearance and administration: Ameluz® is for cutaneous use only,
treatment may be impaired if the treated area is affected rate of narrow spectrum lamps (see section 5.1) Most supplied in a 2g tube administered under supervision of a by the presence of skin diseases (skin inflammation, adverse reactions occur during illumination or shortly healthcare professional experienced in the use of located infection, psoriasis, eczema, and benign or afterwards. The symptoms are usually of mild or moderate photodynamic therapy. Adults and elderly: The gel
malignant skin cancers) as well as tattoos. No experience intensity (investigator’s assessment on a 4-point scale), should cover the lesions and approximately 5mm of the exists with these situations. No experience exists for the and last for 1 to 4 days in most cases; in some cases, surrounding area with a film of about 1 mm thickness. The treatment of BCC and Bowen’s disease, which should however, they may persist for 1 to 2 weeks or even longer. entire treatment area will be illuminated with an therefore not be treated with the product. Ameluz® should
In rare cases, the adverse reactions may require appropriate red light source. See SPC for further not be used on bleeding lesions. Concomitant use of interruption or discontinuation of the illumination. No instructions for use and handling. Paediatric population:
medicinal products with known phototoxic or photoallergic serious side effects have been observed to date. Please potential such as St. John’s wort, griseofulvin, thiazide see SPC for further details on side effects. Contraindications:
diuretics, sulfonylureas, phenothiazines, sulphonamides, Shelf-life:
substance, to porphyrins or to any of the excipients. quinolones and tetracyclines may enhance the phototoxic opening:12 weeks. Storage: Store in a refrigerator (2-
Porphyria. Known photodermatoses of varying pathology reaction to photodynamic therapy. Concomitant use with 8°C). Keep the tube tightly closed after first opening. Legal
and frequency, e.g. metabolic disorders such as other topical medicinal products should be avoided. Any Category: POM Basic UK NHS cost: £184 per 2g tube.
aminoaciduria, idiopathic or immunological disorders such UV-therapy should be discontinued before treatment. Market authorization holder: Biofrontera Bioscience
as polymorphic light reaction, genetic disorders such as Ameluz® contains soybean phosphatidylcholine and should
GmbH . Hemmelrather Weg 201.51377 Leverkusen. xeroderma pigmentosum, and diseases precipitated or not be applied to patients known to be allergic to peanut or Germany. Tel: +49-214-87632-66 Fax: +49-214-87632-90 aggravated by exposure to sun light such as lupus soya. The excipient sodium benzoate may be mildly irritant to the skin, eyes and mucous membranes Propylene glycol Market authorization number: EU/1/11/740/001
Pregnancy: Ameluz® is not recommended during
may cause irritation. Drug Interactions: No clinical drug
Item number: SH/AMLZ/382/JUL2013
pregnancy and in women of childbearing potential not interactions are known. Side effects: In clinical trials with
Date of preparation:8th July 2013
using contraception. Lactation: As a precautionary
Ameluz®, local skin reactions at the application site were
measure, breast-feeding should be interrupted for 12 observed in about 90% of the subjects. This is to be


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