AMELUZ 78 MGG GEL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

5-AMINOLEVULINIC ACID AS HYDROCHLORIDE

Available from:

PERRIGO ISRAEL AGENCIES LTD, ISRAEL

ATC code:

L01XD04

Pharmaceutical form:

GEL

Composition:

5-AMINOLEVULINIC ACID AS HYDROCHLORIDE 78 MG/G

Administration route:

CUTANEOUS

Prescription type:

Required

Manufactured by:

BIOFRONTERA PHARMA GMBH, GERMANY

Therapeutic area:

AMINOLEVULINIC ACID

Therapeutic indications:

Treatment of actinic keratosis of mild to moderate intensity on the face and scalp (Olsen grade 1 to 2).

Authorization date:

2016-04-04

Patient Information leaflet

لامعتسلإا تاداشرإ
مس١اهردق ةفاسم ىلع ةظفاحملاو سامتلا
بنجت بجي .طقف دلجلا ىلع ءاودلا لامعتسإ
بجي
.ةفزانلا تافلآل وأ ةيطاخملا ةجسنلأل
،نينذلأل ،مفلل ،نيرخنملل ،نينيعلل
لجلا نيب لقلأا ىلع
.ءاملاب اهفطش بجيف ،
ً
افنآ ركذ يتلا قطانملا نم دحاو ءاودلا
سملا اذإ
مكحم دامضب ةجلاعملا ةقطنملا ةيطغت لبق
ً
ابيرقت قئاقد ١٠ةدمل فجيل لجلل حامسلا
بجي
.لجلا اياقب فيظنتو تاعاس٣ دعب دامضلا
ةلازإ بجي .ءوضلل لزاع دشلا
فيظنتلا دعب
.فيظنتلا دعب
ً
لااح ةجلاعملا ةقطنملا لماك ىلع رمحأ
ءوض عاعشإ طيلست متي
.جلاعلا يف لمعتسملا ءوضلا ردصمب قلعتت
(تقؤم ملأ لثم) ةيبناجلا ضارعلأاو
ةعاجنلا نإ
يتلا ةزهجلاأب ةقلعتملا ناملأا تاميلعت
ىلع صرحلا يبطلا مقاطلا درفو جلاعتملا
ىلع بجوتي
عاعشإ طيلست ةرتف للاخ ةيقاولا
تاراظنلا عضو كلذكو جلاعلا ةرتف للاخ
ءوضلا عشت
.جلاع زاتجي لا يذلا ميلسلا دلجلا
ةيامحب ةجاح لا .ءوضلا
جلاعلا ةرتف
كانه تلاز ام اذإ .جلاعلا نم رهشأ ٣ دعب
تافلآل مييقت ءارجإو صحفلا بجي
.يفاضإ جلاع ءارجإ بجيف ،تافآ
.يلديصلا وأ بيبطلا رشتسإ ،ءاودلا
لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت
اذإ
.طقف يجراخلا لامعتسلإل
ةيبناجلا ضارعلأا )٤
.نيلمعتسملا ضعب دنع ةيبناج
ً
اضارعأ ببسي دق لج زوليمأ لامعتسإ نإ
،ءاود لكب امك
ضارعلأا ثدحت .اهنم
ً
ايأ يناعت لاأ زئاجلا ن�

Summary of Product characteristics

THIS LEAFLET FORMAT WAS DETERMINED BY THE MINISTRY OF HEALTH AND THE
CONTENT WAS
CHECKED AND APPROVED IN MARCH 2016
PRESCRIBING INFORMATION
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), 3.0 mg soybean
phosphatidylcholine,
and 10.0 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 intensity on the
face and scalp (Olsen
grade 1 to 2; see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ameluz should only be administered under the supervision of a
physician, a nurse or other
healthcare professionals experienced in the use of photodynamic
therapy.
Posology in adults including the elderly
One session of photodynamic therapy should be administered for single
or multiple lesions.
Actinic keratosis lesions should be evaluated three months after
treatment. Non- or partially
responding lesions should be re-treated in a second session. The gel
should cover the lesions
and approximately 5 mm of the surrounding area with a film of about 1
mm thickness. The
entire treatment area will be illuminated with a red light source,
either with a narrow spectrum
around 630 nm and a light dose of approximately 37 J/cm
2
or a broader and continuous
spectrum in the range between 570 and 670 nm with a light dose between
75 and 200 J/cm
2
. 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
the illumination time. These factors vary with lamp type. The light
dose delivered should be
monitored if a suitable detector is available.
Paediatric population
There is no relevant use of Ameluz in the paediatric population.