1. Treatment of actinic keratosis of mild to moderate severity (Olsen grade 1 to 2) and of field cancerization in adults.
2. 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.

Antineoplastic agents, sensitizers used in photodynamic/radiation therapy

1. Hypersensitivity to the active substance, to porphyrins, to soya or to peanuts.
2. Porphyria

Preferable to avoid the use of Ameluz during pregnancy.
1. There are no or limited amount of data from the use of 5-aminolaevulinic acid in pregnant women.
2. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Breast-feeding should be discontinued for 12 hours after treatment with Ameluz.
(It is unknown whether 5-aminolaevulinic acid/metabolites are excreted in human milk. A risk to thesuckling child cannot be excluded.)

>10%：Erythema, pain (incl. burning pain), irritation, pruritus, oedema, scab, exfoliation, induration, paraesthesia at application site.
1-10%：Vesicles, discharge, erosion, reaction, discomfort, hyperalgesia, haemorrhage, warmth at application site. Headache.

Ameluz should only be administered under the supervision of a physician, a nurse or other healthcare professional experienced in the use of photodynamic therapy.

There is no relevant use of Ameluz in the paediatric population. No data are available.

Shelf life：12 weeks after first opening