Ameluz

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

5-aminolevulinic acid hydrochloride

Saadav alates:

Biofrontera Bioscience GmbH

ATC kood:

L01XD04

INN (Rahvusvaheline Nimetus):

5-aminolevulinic acid hydrochloride

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Keratosis, Actinic; Carcinoma, Basal Cell

Näidustused:

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.

Toote kokkuvõte:

Revision: 19

Volitamisolek:

Authorised

Loa andmise kuupäev:

2011-12-13

Infovoldik

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

Toote omadused

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