Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ameluz

Document Subject

Generated Narrative: MedicinalProductDefinition mp27a52606a6d06c382d79e38520d58ce1

identifier: http://ema.europa.eu/identifier/EU/1/11/740/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ameluz 78 mg/g gel

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-27a52606a6d06c382d79e38520d58ce1

identifier: http://ema.europa.eu/identifier/EU/1/11/740/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ameluz

Attesters

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

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).

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 or peanuts

• if you have impaired formation of red blood pigment called porphyria
• if you have other skin conditions caused by, or made worse by, exposure to light

Warnings and precautions Talk to your doctor before using Ameluz.

• In very rare cases photodynamic therapy may increase the risk of developing temporary memory loss.
• The use of Ameluz is not recommended if you use immunosuppressants.
• Avoid applying Ameluz

to bleeding lesions

into eyes or to mucous membranes

on skin areas affected by other diseases or tattoos, because this may hinder the success and assessment of the treatment.

• Discontinue any UV-therapy before treatment.
• Avoid sun exposure on the treated lesion sites and surrounding skin for approximately 48 hours following treatment.

Children and adolescents
Actinic keratoses and basal cell carcinomas do not occur in children and adolescents, except in extremely rare cases.

Other medicines and Ameluz Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Inform your doctor if you use medicines that increase allergic or other harmful reactions after light exposure, such as

• St. John s wort or its preparations: medicines to treat depression
• griseofulvin: a medicine to treat fungal infections
• medicines to increase water output through your kidneys with active substance names mostly ending in thiazide or tizide , such as hydrochlorothiazide
• certain medicines to treat diabetes, such as glibenclamide, glimepiride
• medicines to treat mental disorders, nausea or vomiting with active substance names mostly ending in azine , such as phenothiazine
• medicines to treat bacterial infection with active substance names beginning with sulfa or ending in oxacin or cycline , such as tetracycline

Pregnancy and breast-feeding Ameluz is not recommended during pregnancy, due to insufficient knowledge. Breast-feeding should be interrupted for 12 hours after application of Ameluz.

Driving and using machines Ameluz has no or negligible influence on the ability to drive and use machines.

Ameluz contains

• 2.4 mg sodium benzoate (E211) in each gram of gel. Sodium benzoate may cause local irritation.
• soybean phosphatidylcholine: If you are allergic to peanut or soya, do not use this medicine.
• propylene glycol: May cause skin irritation.

Ameluz is only used on the skin. A therapy session can be administered for single or multiple lesions, or entire treatment fields. The illumination source for PDT treatment of actinic keratoses lesions or fields can be daylight or a red-light lamp. Your doctor will decide which treatment option to use, depending on your lesions.
The illumination source for PDT of actinic keratosis in the body regions trunk, neck and extremities is a narrow-spectrum red-light. There are no data of efficacy of broader spectrum lamps or daylight PDT in these body regions.

The illumination source for PDT of basal cell carcinoma is always a red-light lamp.

Treatment of lesions or fields of actinic keratoses and basal cell carcinoma using a red-light lamp

Preparation of the lesions

The application area is first wiped with an alcohol-soaked cotton pad to degrease the skin. Scales and crusts are then carefully removed, and all lesion surfaces are gently roughened. Care is taken to avoid bleeding.

Application of the gel
Ameluz is applied to form a film of about 1 mm thickness to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula. Avoid any contact with the eyes, nostrils, mouth, ears, mucous membrane or bleeding lesions. A distance of at least 1 cm is to be maintained. Rinse with water if such contact occurs. The gel is allowed to dry for approximately 10 minutes before placing a light-tight dressing over the treatment site. The dressing is removed after 3 hours. The remaining gel is wiped off.

Illumination using a red-light lamp
The use of Ameluz requires specific knowledge in photodynamic therapy as it may necessitate the use of a red-light lamp.
Immediately after cleaning, the entire treated area is illuminated using a red light source. Efficacy and side effects such as temporary pain are dependent on the light source used. Both patients and healthcare professionals should adhere to any safety instructions provided with the light source used during therapy. All should wear suitable protective goggles during illumination. There is no need to protect healthy untreated skin.

Treatment of lesions and fields of actinic keratoses with daylight

Considerations before treatment
Only use daylight treatment if the weather is suitable to stay comfortably outdoors for two hours (with temperatures > 10 C). If the weather is rainy, or is likely to become so, you should not use daylight treatment.

Preparation of the lesions
Apply sunscreen to sun exposed skin for sun protection 15 min before lesion treatment. Only use sunscreen with chemical filters and sun protection factor 30 or higher. Do not use sunscreen with physical filters such as titanium dioxide, zinc oxide, as these inhibit light absorption and may therefore impact efficacy. Then wipe the application area with an alcohol-soaked cotton pad to degrease the skin. Carefully removed scales and crusts and gently roughen all lesion surfaces. Take care to avoid bleeding.

Application of the gel Apply Ameluz to form a thin layer to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula.
Avoid any contact with the eyes, nostrils, mouth, ears, mucous membrane or bleeding lesions, maintaining a distance of at least 1 cm. Rinse with water if such contact occurs. A light-tight dressing is not necessary. Do not wipe off the gel during the entire daylight treatment session.

Illumination using daylight for actinic keratosis treatment If weather conditions are suitable (please see above; Considerations before treatment), you should go outside within 30 minutes after application of the gel and stay for 2 continuous hours in full daylight. Taking shelter in the shade in hot weather is acceptable. If the time outdoors is interrupted, you should compensate this with a longer illumination time. After the two hour light exposure, wash off the remaining gel.

Number of treatments

• Lesions and fields of actinic keratoses are treated with one session.
• Basal cell carcinoma is treated with two sessions, with an interval of one week between sessions.

The treated lesions should be evaluated 3 months after treatment. Your doctor will decide how well each skin lesion has responded, and treatment may have to be repeated at this time.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects at the application site occur in about 9 out of 10 users and indicate that the affected cells are responding to treatment.

Generally, side effects are of mild or moderate intensity, typically occurring during illumination or 1 to 4 days after. However, in some cases they may persist for 1 to 2 weeks or even longer. In rare cases, interruption or discontinuation of illumination may be necessary. After more extended time periods, treatment with Ameluz frequently results in continued improvement of skin quality parameters.

The side effects listed below have been reported when using Ameluz with a red-light lamp. The study of Ameluz using daylight showed similar types of side effects; however, with lower intensity. Some reactions at the application site have been observed before the use of light.

Very common: may affect more than 1 in 10 people

• reactions at the application site

skin reddening

pain (incl. burning)

irritation

itching

tissue swelling caused by excess fluid

scab

scaling of the skin

hardening

abnormal sensation, such as pricking, tingling or numbness

Common: may affect up to 1 in 10 people

• reactions at the application site

vesicles

discharge

abrasion

other reaction

discomfort

increased sensitivity to pain

bleeding

warmth

• headache

Uncommon: may affect up to 1 in 100 people

• reactions at the application site

change of colour

pustules

ulcer

swelling

inflammation

eczema with pustules

allergic reaction1

• blister

• dry skin

• eyelid swelling caused by excess fluid, blurred vision or visual impairment

• unpleasant, abnormal sense of touch

• chills

• feeling hot, fever, hot flush

• temporary memory loss1

• pain

• nervousness

• wound secretion

• fatigue

• rash, red or purple spots on the body

• ulcer

• swelling

• skin tightness 1 Data from post-marketing

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C).

Keep the tube tightly closed after first opening. Discard open tubes 12 weeks after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ameluz contains

• The active substance is 5-aminolaevulinic acid. 1 g Ameluz contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
• The other ingredients are: disodium phosphate dihydrate, isopropyl alcohol, polysorbate 80, propylene glycol, purified water, sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, soybean phosphatidylcholine, triglycerides medium-chain, xanthan gum. See section 2. What Ameluz looks like and contents of the pack Ameluz is a white to yellowish gel. Each carton contains one aluminium tube with 2 g gel closed with a polyethylene screw cap.

Marketing Authorisation Holder
Biofrontera Bioscience GmbH
Hemmelrather Weg 51377 Leverkusen, Germany Tel: +49 214 87632 66, Fax: +49 214 87632 Email: ameluz@biofrontera.com

Manufacturer Biofrontera Pharma GmbH Hemmelrather Weg 51377 Leverkusen, Germany Tel: +49 214 87632 66, Fax: +49 214 87632 Email: ameluz@biofrontera.com

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Biofrontera Pharma GmbH
Duitsland / Allemagne / Deutschland
T l/Tel: +49 214 87632 ameluz@biofrontera.com

Biofrontera Pharma GmbH

Te .: +49 214 87632 ameluz@biofrontera.com

esk republika Biofrontera Pharma GmbH
N mecko
Tel: +49 214 87632 ameluz@biofrontera.com

Danmark Galenica AB Sverige Tlf: +46 40 32 10 info@galenica.se

Deutschland Biofrontera Pharma GmbH
Tel: +49 214 87632 ameluz@biofrontera.com

Eesti Biofrontera Pharma GmbH
Saksamaa
Tel: +49 214 87632 ameluz@biofrontera.com

Biofrontera Pharma GmbH

: +49 214 87632 ameluz@biofrontera.com

Espa a Biofrontera Pharma GmbH sucursal en Espa a Tel: 900 974ameluz-es@biofrontera.com

France Biofrontera Pharma GmbH Allemagne T l: 0800 904ameluz-fr@biofrontera.com

Hrvatska Biofrontera Pharma GmbH
Njema ka
Tel: +49 214 87632 ameluz@biofrontera.com

Ireland Biofrontera Pharma GmbH
Germany
Tel: +49 214 87632 ameluz@biofrontera.com

sland Galenica AB Sv j
S mi: +46 40 32 10 info@galenica.se

Italia Biofrontera Pharma GmbH
Germania Tel: +49 214 87632 ameluz@biofrontera.com

Biofrontera Pharma GmbH

: +49 214 87632 ameluz@biofrontera.com

Latvija Biofrontera Pharma GmbH
V cija
Tel: +49 214 87632 ameluz@biofrontera.com

Lietuva Biofrontera Pharma GmbH
Vokietija Tel: +49 214 87632 ameluz@biofrontera.com

Luxembourg/Luxemburg Biofrontera Pharma GmbH
Allemagne / Deutschland
T l/Tel: +49 214 87632 ameluz@biofrontera.com

Magyarorsz g Biofrontera Pharma GmbH
N metorsz g Tel.: +49 214 87632 ameluz@biofrontera.com

Malta Biofrontera Pharma GmbH
Il- ermanja
Tel: +49 214 87632 ameluz@biofrontera.com

Nederland Biofrontera Pharma GmbH
Duitsland
Tel: +49 214 87632 ameluz@biofrontera.com

Norge Galenica AB Sverige Tlf: +46 40 32 10 info@galenica.se

sterreich Pelpharma Handels GmbH Tel: +43 2273 70 ameluz@pelpharma.at

Polska medac GmbH Sp. z o.o. Oddzia w Polsce Tel.: +48 (0)22 430 00 kontakt@medac.pl

Portugal Biofrontera Pharma GmbH
Alemanha
Tel: +49 214 87632 ameluz@biofrontera.com

Rom nia Biofrontera Pharma GmbH
Germania Tel: +49 214 87632 ameluz@biofrontera.com

Slovenija Biofrontera Pharma GmbH
Nem ija
Tel: +49 214 87632 ameluz@biofrontera.com

Slovensk republika Biofrontera Pharma GmbH
Nemecko Tel: +49 214 87632 ameluz@biofrontera.com

Suomi/Finland Galenica AB Ruotsi Puh/Tel: +46 40 32 10 info@galenica.se

Sverige Galenica AB Tfn: +46 40 32 10 info@galenica.se

United Kingdom (Northern Ireland) Biofrontera Pharma GmbH
Germany
Tel: +49 214 87632 ameluz@biofrontera.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: