Ameluz 78mgg gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aminolevulinic acid hydrochloride

Available from:

Biofrontera Pharma GmbH

INN (International Name):

Aminolevulinic acid hydrochloride

Dosage:

78mg/1gram

Pharmaceutical form:

Gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Patient Information leaflet

B. PACKAGE LEAFLET
2
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 on the face
and scalp 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 p

Summary of Product characteristics

OBJECT 1
AMELUZ 78 MG/G GEL
Summary of Product Characteristics Updated 23-Mar-2018 | Biofrontera
Pharma GmbH
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 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.
4.2 Posology and method of administration
Ameluz should only be administered under the supervision of a
physician, a nurse or other healthcare
professional experienced in the use of photodynamic therapy.
Posology in adults
_For treatment of actinic keratoses (AK)_, one session of photodynamic
therapy (with daylight or red-light
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). 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
Th