Ameluz® PRESCRIBING INFORMATION
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: Unopened
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
Psychiatric Alert for Psychiatrists on Prader-Willi Syndrome Janice L. Forster, MD—Child and Adolescent Psychiatrist and Linda M. Gourash, MD—Developmental Pediatrician Reasons for Consultation and Referral meal plan, restricted food access, a plan for daily activities, Prader-Willi syndrome (PWS) is a rare chromosomal disorder mandatory exercise, opportunities for sensory experience,
Surname…………………………. Forename………………………NHS number……………….D.O.B………… Community Respiratory Team MANAGEMENT PLAN – COPD Exacerbation Actual Problem………………………………………………………………………………. Goals agreed with patient, family and nurse Short Term: Long Term: Exacerbation is manag