ALACARE Medicated plaster Ref.[27706] Active ingredients: Aminolevulinic acid

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 instructions provided with the light source. During illumination patient and operator should wear protective goggles which correspond to the lamp light spectrum.

Untreated skin surrounding the lesion does not need to be protected during illumination.

Lesion responses should be assessed after three months. If the area treated with Alacare is not lesion free at 3 months following single use please use alternative therapies for removal of actinic keratosis lesions.

Paediatric population

There is no experience of treating patients below the age of 18 years.

No case of overdose has been reported. Nevertheless, reactions at the treatment site may be more pronounced if the Alacare plasters are applied for much more than 4 hours or if a much higher light dose than the recommended 37 J/cm² is chosen.

3 years. Use within 3 months after first opening.

After opening store plaster in the sachet in order to protect from light.

4 medicated plasters sealed in protective sachets consisting of 4 layers: paper (outer layer), polyethylene LDPE, aluminium, ethylene copolymer (inner layer).

Pack sizes of 4 or 8 medicated plasters (1 or 2 protective sachet(s)).

Not all pack sizes may be marketed.

After removal, the used patch should be folded in half, adhesive side inwards so that the adhesive is not exposed, and then discarded safely.