Alacare 8 mg Medicinskt plåster

Maa: Ruotsi

Kieli: ruotsi

Lähde: Läkemedelsverket (Medical Products Agency)

Aktiivinen ainesosa:

aminolevulinsyrahydroklorid

Saatavilla:

Photonamic GmbH & Co. KG

ATC-koodi:

L01XD04

INN (Kansainvälinen yleisnimi):

aminolevulinic acid hydrochloride

Annos:

8 mg

Lääkemuoto:

Medicinskt plåster

Koostumus:

aminolevulinsyrahydroklorid 10,224 mg Aktiv substans

luokka:

Apotek

Prescription tyyppi:

Receptbelagt

Terapeuttinen alue:

Aminolevulinsyra

Tuoteyhteenveto:

Förpacknings: Påse, 4 plåster; Påse, 8 (2 x 4) plåster

Valtuutuksen tilan:

Godkänd

Valtuutus päivämäärä:

2009-10-23

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALACARE 8 MG MEDICATED PLASTER
5-aminolevulinic 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 Alacare is and what it is used for
2. What you need to know before you use Alacare
3. How to use Alacare
4. Possible side effects
5. How to store Alacare
6.
Contents of the pack and other information
1.
WHAT ALACARE IS AND WHAT IT IS USED FOR
Alacare is used for the treatment of mild skin abnormalities on the
head or face called solar keratosis.
These are small, rough, spots which develop on the skin. They are
caused by a lot of exposure to the
sun over many years. They are also called actinic keratosis.
Treatment with Alacare is a two-step procedure and is called
‚photodynamic therapy’. It consists of
Alacare plaster application to the spots for 4 hours. This is followed
by illumination with red light for
a couple of minutes. Illumination with red light induces a chemical
reaction in the cells of the changed
skin, which leads to their destruction. The reaction is called
‚phototoxic reaction’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALACARE
Alacare should be applied by a physician, a nurse or other health care
professionals in one single
session.
DO NOT USE ALACARE:
-
if you are allergic to 5-aminolevulinic acid or any of the other
ingredients of
this medicine
(listed in section 6).
.
_ _
-
if you suffer from a certain disease of blood metabolism known as
porphyria.
-
if you were undergoing similar therapy with 5-aminolevulinic
acid-containing preparations and it
was unsucce

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alacare 8 mg medicated plaster
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicated plaster of 4 cm
2
contains 8 mg 5-aminolevulinic acid, 2 mg per cm
2
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Medicated plaster.
Each plaster has a size of 4 cm
2
, is square with rounded corners and consists of a skin tone backing
foil
and a self-adhesive matrix, covered by a release liner which is
removed prior to use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Single use treatment of mild actinic keratoses with a maximum diameter
of 1.8 cm on the face and
scalp (hairless areas).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_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/cm
2
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