FrancophonIA/ELRC3.0 huggingface dataset:
English: After more extended time periods, treatment with Ameluz frequently results in continued improvement of skin quality parameters.
Croatian: Nakon duljih razdoblja, liječenje lijekom Ameluz često dovodi do kontinuirano poboljšanih parametara kvalitete kože.
English: • soybean phosphatidylcholine: If you are allergic to peanut or soya, do not use this medicine.
Croatian: • sojin fosfatidilkolin: Ako ste alergični na kikiriki ili soju, nemojte koristiti ovaj lijek.
English: 1 This reaction also occurs before illumination.
Croatian: 1Ova reakcija također se javlja prije osvjetljavanja.
English: • unpleasant, abnormal sense of touch
Croatian: • neugodan, nenormalni osjet dodira
English: During illumination the lamp should be fixed at the distance from the skin surface that is indicated in the user manual.
Croatian: Tijekom osvjetljavanja lampa treba biti učvršćena na udaljenosti od površine kože kako je naznačeno u korisničkom priručniku.
English: Remaining gel will be removed after completion of light exposure.
Croatian: Preostali gel ukloni se nakon završetka izlaganja svjetlu.
English: Actinic keratoses and basal cell carcinomas do not occur in children and adolescents, except in extremely rare cases.
Croatian: Aktinička keratoza i bazocelularni karcinomi ne javljaju se u djece i adolescenata osim u krajnje iznimnim slučajevima.
English: The symptoms are usually of mild or moderate intensity (investigator's assessment on a 4-point scale), and last for 1 to 4 days in most cases; in some cases, however, they may persist for 1 to 2 weeks or even longer.
Croatian: Simptomi su obično blagi ili umjereni (ocjena ispitivača na 4-stupanjskoj ljestvici), a u većini slučajeva traju 1 do 4 dana; međutim u nekim slučajevima mogu ustrajati 1 do 2 tjedna ili duže.
English: Email: ameluz@biofrontera.com
Croatian: E-pošta: ameluz@biofrontera.com
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovoga lijeka, obratite se liječniku ili medicinskoj sestri.
English: Your doctor will decide which treatment option to use, depending on your lesions.
Croatian: Liječnik će odlučiti koja će se vrsta liječenja primijeniti ovisno o stanju Vaših lezija.
English: Blister, dry skin, petechiae
Croatian: Mjehur, suha koža, petehije
English: Mottled or irregular pigmentation
Croatian: Mrljasta ili nepravilna pigmentacija
English: Side effects at the application site occur in about 9 out of 10 users and indicate that the affected cells are responding to treatment.
Croatian: Nuspojave na mjestu nanošenja javljaju se kod oko 9 od 10 korisnika i ukazuju na to da zahvaćene stanice odgovaraju na liječenje.
English: The intensity of these effects is dependent on the type of illumination used for photodynamic therapy.
Croatian: Intenzitet tih učinaka ovisi o tipu osvjetljavanja upotrijebljenog za fotodinamsku terapiju.
English: All should wear suitable protective goggles during illumination.
Croatian: Svi moraju tijekom osvjetljavanja nositi zaštitne naočale.
English: 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.
Croatian: Doza svjetlosti određuje se čimbenicima kao što su veličina svjetlosnog polja, udaljenost između lampe i površine kože, te vrijeme osvjetljavanja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/740/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/740/001
English: Each tube contains 2 g of gel.
Croatian: Svaka tuba sadrži 2 g gela.
English: Each side of the face/scalp was treated with one of the two products.
Croatian: Na svaku stranu lica/vlasišta primjenjivao se jedan od ta dva lijeka.
English: • if you have other skin conditions caused by, or made worse by, exposure to light
Croatian: • ako imate druga stanja kože koja uzrokuje ili pogoršava izlaganje svjetlosti.
English: As a precautionary measure, it is preferable to avoid the use of Ameluz during pregnancy.
Croatian: Kao mjera opreza, bolje je izbjegavati primjenu lijeka Ameluz tijekom trudnoće.
English: Ameluz is not recommended during pregnancy, due to insufficient knowledge.
Croatian: Trudnoća i dojenje Ameluz se ne preporučuje tijekom trudnoće zbog nedostatnih saznanja.
English: Although the exact mechanism is not known, stress and pain associated with PDT may increase the risk to develop transient amnesia.
Croatian: Iako točan mehanizam nije poznat, stres i bol povezani s fotodinamskom terapijom mogu povećati rizik od razvoja prolazne amnezije.
English: After the two hour light exposure, wash off the remaining gel.
Croatian: Nakon dva sata izlaganja svjetlosti, isperite preostali gel.
English: None of the post-dose levels were increased in comparison to the naturally occuring predose levels, showing absence of a relevant systemic absorption after topical administration.
Croatian: Nijedna razina nakon doziranja nije povišena u usporedbi s prirodnim razinama prisutnim prije doziranja, što ukazuje na odsutnost značajne sistemske apsorpcije nakon topikalne primjene.
English: Take care to avoid bleeding.
Croatian: Pazite da se izbjegne krvarenje.
English: It is important to ensure that the correct light dose is administered.
Croatian: Važno je osigurati primjenu ispravne doze svjetlosti.
English: Other medicines and Ameluz Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Ameluz has no or negligible influence on the ability to drive and use machines.
Croatian: Ameluz ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Illumination with appropriate light produces reactive oxygen-containing molecules which act against the target cells.
Croatian: Osvjetljavanje odgovarajućim svjetlom stvara reaktivne molekule koje sadrže kisik koje djeluju na ciljne stanice.
English: 3 severe very thick and / or obvious AK
Croatian: 3 jaka vrlo debele i/ili očite aktiničke keratoze
English: White to yellowish gel.
Croatian: Bijeli do žućkasti gel.
English: Most adverse reactions occur during illumination or shortly afterwards.
Croatian: Najviše nuspojava se javi tijekom osvjetljavanja ili ubrzo nakon toga.
English: Lesions should be re-assessed after three months, at which point any residual lesions or fields may be retreated.
Croatian: Lezije je potrebno ponovno ocijeniti nakon tri mjeseca, kada se mogu ponovo liječiti sve preostale lezije ili područja.
English: What Ameluz is and what it is used for
Croatian: Što se nalazi u ovoj uputi Što je Ameluz i za što se koristi
English: Furthermore, a publication was identified reporting on occurrence of contact dermatitis after treatment with 5-aminolevulinic acid or methyl-aminolevulinic acid.
Croatian: Nadalje, pronađena je publikacija koja opisuje pojavu kontaktnog dermatitisa nakon liječenja 5-aminolevulinatnom kiselinom ili metilaminolevulinatnom kiselinom.
English: What you need to know before you use Ameluz
Croatian: Što morate znati prije nego počnete primjenjivati Ameluz
English: Ameluz should only be administered under the supervision of a physician, a nurse or other healthcare professional experienced in the use of photodynamic therapy.
Croatian: Ameluz se smije primijeniti samo pod nadzorom liječnika, medicinske sestre ili drugog zdravstvenog radnika s iskustvom u primjeni fotodinamske terapije.
English: BCCs located in this region mainly belong to the superficial subtype.
Croatian: Bazocelularni karcinomi koji se nalaze u tom području uglavnom pripadaju površinskoj podvrsti.
English: A therapy session can be administered for single or multiple lesions, or entire treatment fields.
Croatian: Terapija se može primijeniti na jednu ili višestruke lezije ili na cijelo područje liječenja.
English: Fertility There are no data available on the effect of 5-aminolaevulinic acid on fertility.
Croatian: Plodnost Nema dostupnih podataka o učinku 5-aminolevulinatne kiseline na plodnost.
English: Number of treatments
Croatian: Broj tretmana
English: Following 3 hours of incubation, the dressing should be removed and the remnant gel wiped off.
Croatian: Nakon 3 sata inkubacije, zavoj treba skinuti, a ostatak gela obrisati.
English: In clinical phase III, a total of 436 patients were treated with Ameluz.
Croatian: U kliničkom ispitivanju faze III, ukupno je 436 bolesnika bilo liječeno lijekom Ameluz.
English: Immediately after cleaning, the entire treated area is illuminated using a red light source.
Croatian: Odmah nakon čišćenja lezija, cijelo se područje liječenja osvjetljava izvorom crvene svjetlosti.
English: All skin quality parameters in the treated area continuously improved up to the 12-month follow-up time point.
Croatian: Svi parametri kvalitete kože na liječenom području neprekidno su se poboljšavali sve do kraja 12-mjesečnog praćenja.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000
Croatian: Učestalosti su definirane kao vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 do
English: Generally, side effects are of mild or moderate intensity, typically occurring during illumination or 1 to 4 days after.
Croatian: Obično su nuspojave blagog ili umjerenog intenziteta, a tipično se javljaju tijekom osvjetljavanja ili nakon 1 do 4 dana.
English: If amnesia is observed, the PDT must be discontinued immediately (see section 4.8).
Croatian: Ako se opazi amnezija, fotodinamska terapija mora se odmah prekinuti (vidjeti dio 4.8).
English: Ameluz should not be used on skin areas affected by other diseases or tattoos.
Croatian: Ameluz se ne smije primjenjivati na područjima kože zahvaćenima drugom bolešću ili tetoviranim područjima.
English: The gel can be administered to healthy skin around the lesions, whereas application near the eyes, nostrils, mouth, ears or mucosa should be avoided (keep a distance of 1 cm).
Croatian: Gel se može nanijeti na zdravu kožu oko lezija, ali treba izbjegavati nanošenje blizu očiju, nosnica, usta, ušiju ili sluznica (na udaljenosti od 1 cm).
English: Photodynamic therapy with Ameluz (66.3%) was significantly more effective than with placebo (12.5%, p < 0.0001).
Croatian: Fotodinamska terapija uz Ameluz (66,3%) je bila značajno učinkovitija nego uz placebo (12,5%, p < 0,0001).
English: Clinical description of severity grading
Croatian: Klinički opis ocjenjivanja težine
English: The plasma concentrations of metabolite PpIX were generally low in all patients and in none of the patients, an obvious increase of PpIX plasma concentrations was observed after Ameluz application.
Croatian: Koncentracije metabolita PpIX u plazmi bile su općenito niske u svih bolesnika i ni u jednog bolesnika nije bilo opaženo povećanje koncentracija PpIX u plazmi nakon primjene
English: The technical specifications of the device need to be checked before using a specific light source, and the requirements must be met for the intended light spectrum.
Croatian: Prije primjene određenog izvora svjetlosti potrebno je provjeriti tehničke specifikacije uređaja, a moraju biti zadovoljeni zahtjevi za željeni spektar svjetlosti.
English: Efficacy and side effects such as temporary pain are dependent on the light source used.
Croatian: Djelotvornost i nuspojave kao što je privremena bol ovise o upotrijebljenom izvoru svjetlosti.
English: 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.
Croatian: Bazocelularni karcinom je rak kože koji uzrokuje crvenkaste, ljuskave promjene ili jednu ili više kvržica koje lako krvare i ne mogu zacijeliti.
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakivigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: A broader and continuous spectrum may be used if narrow-spectrum light sources are not tolerated (see sections 4.8 and 5.1).
Croatian: Moguće je primijeniti širi i kontinuirani spektar ako bolesnik ne podnosi izvore svjetla uskog spektra (vidjeti dijelove 4.8 i 5.1).
English: As inflammatory response is important for the effect of PDT, the trials investigating the efficacy and safety of Ameluz excluded patients who were undergoing treatment with immunosuppression therapy.
Croatian: Budući da je upalni odgovor važan za učinak fotodinamske terapije, ispitivanja djelotvornosti i sigurnosti lijeka Ameluz isključila su bolesnike u kojih se provodilo liječenje imunosupresivnom terapijom.
English: • feeling hot, fever, hot flush
Croatian: • osjećaj vrućine, vrućica, navale vrućine
English: Some reactions at the application site have been observed before the use of light.
Croatian: Neke reakcije na mjestu nanošenja opažene su prije primjene svjetlosti.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for 5-aminolevulinic acid (keratosis), the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za 5-aminolevulinatnu kiselinu (keratoza), znanstveni zaključci CHMP-a su sljedeći:
English: * Data from post-marketing period.
Croatian: *Podaci iz razdoblja nakon stavljanja lijeka u promet.
English: The remaining gel is wiped off.
Croatian: Preostali gel se obriše.
English: Patient distribution in the subgroups was similar for both products and represents the distribution in the general population, where more than 70% of BCCs are located in the head/trunk region.
Croatian: Raspodjela bolesnika po podskupinama bila je slična za oba lijeka i reprezentativna je za raspodjelu u općoj populaciji u kojoj se više od 70% bazocelularnih karcinoma nalazi na području glave/trupa.
English: Nodular BCC lesions are often covered by an intact epidermal keratin layer which should be removed.
Croatian: Nodularne lezije bazocelularnog karcinoma često su prekrivene neoštećenim slojem epidermalnog keratina koji je potrebno ukloniti.
English: 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.
Croatian: Liječenje aktiničke keratoze blage do umjerene težine na licu i vlasištu (stupanj 1 do 2 po Olsenu; vidjeti dio 5.1) i područne zloćudne transformacije u odraslih.
English: If the time outdoors is interrupted, you should compensate this with a longer illumination time.
Croatian: Ako se prekine taj boravak vani, morate to kompenzirati duljim vremenom osvjetljavanja.
English: The success and assessment of treatment may be impaired if the treated area is affected by the presence of skin diseases (skin inflammation, located infection, psoriasis, eczema, and malignant skin cancers) as well as tattoos.
Croatian: Uspješnost i ocjena liječenja mogu biti umanjene ako je liječeno područje zahvaćeno kožnim bolestima (upala kože, lokalna infekcija, psorijaza, ekcem, te benigni ili maligni karcinomi kože) kao i tetovažama.
English: What Ameluz contains
Croatian: Što Ameluz sadrži
English: The study of Ameluz using daylight showed similar types of side effects; however, with lower intensity.
Croatian: Ispitivanje lijeka Ameluz pod danjim svjetlom pokazalo je slične vrste nuspojava, međutim, manjeg intenziteta.
English: This therapy is known as photodynamic therapy (PDT).
Croatian: Ova je terapija poznata kao fotodinamska terapija.
English: It is recommended that the response of BCC lesions may be confirmed by histological examination of biopsy material, if considered necessary.
Croatian: Preporučuje se provjeriti odgovor lezija bazocelularnog karcinoma patohistološkim pregledom materijala uzetog biopsijom, ako se to smatra potrebnim.
English: The increased effects correlate with the higher clearance rate of narrow spectrum lamps (see section 5.1).
Croatian: Pojačani učinci srazmjerni su većoj brzini uklanjanja lezija kod lampi uskog spektra (vidjeti dio 5.1).
English: Ameluz (78.2%) was significantly more effective than MAL (64.2%, [97.5%- confidence interval: 5.9; ∞]) and placebo (17.1%, [95%confidence interval: 51.2; 71.0]).
Croatian: Ameluz (78,2%) je bio značajno učinkovitiji nego MAL (64,2%, [97,5%-tni interval pouzdanosti: 5,9; ∞]) i placebo (17,1%, [95%-tni interval pouzdanosti: 51,2; 71,0]).
English: • Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematoides or phemphigus erythemtoides.
Croatian: • Poznate fotodermatoze raznih patologija i učestalosti, npr. metabolički poremećaji kao što je aminoacidurija, idiopatski ili imunološki poremećaji kao što je polimorfna reakcija na svjetlo, genetski poremećaji kao što je pigmentna kserodermija, te bolesti izazvane ili pogoršane izlaganjem sunčevom svjetlu kao što su eritematozni lupus ili eritematozni pemfigus.
English: Exposed tumour material should be removed gently without any attempt to excise beyond the tumour margins.
Croatian: Izloženo tumorsko tkivo potrebno je nježno ukloniti bez ikakvog pokušaja ekscizije izvan rubova tumora.
English: It is unknown whether 5-aminolaevulinic acid/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se 5-aminolevulinatna kiselina/ metaboliti u majčino mlijeko.
English: • The use of Ameluz is not recommended if you use immunosuppressants.
Croatian: • Ne preporučuje se primjena lijeka Ameluz ako uzimate imunosupresive.
English: The table additionally includes serious adverse reactions reported post-marketing.
Croatian: U tablicu su dodatno uključene ozbiljne nuspojave prijavljene nakon stavljanja lijeka u promet.
English: Inform your doctor if you use medicines that increase allergic or other harmful reactions after light exposure, such as
Croatian: Obavijestite svog liječnika ako uzimate lijekove koji pojačavaju alergijske ili druge štetne reakcije nakon izlaganja svjetlosti, kao što su • gospina trava ili njezini pripravci: lijekovi za liječenje depresije
English: In most patients an up to 2.5-fold increase of basic ALA plasma concentrations was observed during the first 3 hours after Ameluz application, which is still within the normal range of previously reported and published endogenous ALA concentrations.
Croatian: U većine je bolesnika bilo opaženo povećanje osnovnih koncentracija ALA u plazmi do 2,5 puta tijekom prva 3 sata nakon primjene lijeka Ameluz, što je i dalje unutar raspona normalnih vrijednosti prethodno zabilježenih i objavljenih koncentracija endogenog ALA.
English: Table 4: Efficacy of PDT for the treatment of BCC for all patients and selected subgroups Ameluz Patient number n (%)
Croatian: Tablica 4: Djelotvornost fotodinamske terapije u liječenju bazocelularnog karcinoma (BCC) u svih bolesnika i odabranih podskupina Ameluz Broj bolesnika n (%)
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo često: mogu se javiti kod više od 1 na 10 osoba
English: On sunny days, shelter in the shade could be taken should the patient feel uncomfortable in direct sunlight.
Croatian: Za sunčanih dana, bolesnik se mogao skloniti u hlad ako mu je bilo neugodno biti izložen izravnoj sunčevoj svjetlosti.
English: Avoid any contact with the eyes, nostrils, mouth, ears, mucous membrane or bleeding lesions.
Croatian: Izbjegavajte kontakt lijeka s očima, nosnicama, ustima, ušima, sluznicama ili lezijama koje krvare.
English: Both the patient and the medical personnel conducting the photodynamic therapy should adhere to any safety instructions provided with the light source used.
Croatian: I bolesnik i zdravstveno osoblje koje provodi fotodinamsku terapiju moraju se pridržavati svih sigurnosnih uputa priloženih uz primijenjeni izvor svjetlosti.
English: In both AK studies the clearance rates were higher after illumination with narrow light spectrum devices but the incidence and intensity of administration site disorders (e.g. transient pain, erythema) increased in patients illuminated with these devices (see tables above and section 4.8).
Croatian: U oba su ispitivanja aktiničke keratoze stope očišćenosti bile više nakon osvjetljavanja uređajima uskog spektra svjetlosti ali su se incidencija i intenzitet poremećaja na mjestu primjene (npr. prolazna bol, eritem) povećali u bolesnika osvjetljivanih takvim uređajima (vidjeti gornje tablice i dio 4.8).
English: The red light source was either a narrow light spectrum lamp (Aktilite CL 128 or Omnilux PDT) or a lamp with a broader and continuous light spectrum (Waldmann PDT 1200 L, or Hydrosun Photodyn 505 or 750).
Croatian: Izvor crvenog svjetla bio je ili lampa uskog svjetlosnog spektra (Aktilite CL 128 ili Omnilux PDT) ili lampa šireg i kontinuiranog svjetlosnog spektra (Waldmann PDT 1200 L, ili Hydrosun Photodyn 505 ili 750).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ameluz in all subsets of the paediatric population in actinic keratosis.
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Ameluz u svim podskupinama pedijatrijske populacije za aktiničku keratozu.
English: This is to be expected as the therapeutic principle of photodynamic therapy is based on phototoxic effects of protoporphyrin IX which is synthesized from the active ingredient 5-aminolaevulinic acid.
Croatian: To je očekivano, jer se terapijsko načelo liječenja fotodinamskom terapijom zasniva na fototoksičnim učincima protoporpfirina IX koji se sintetizira iz djelatne tvari 5-aminolevulinatne kiseline.
English: All patients had at least 4 mild to moderate actinic keratosis lesions on the face and/or scalp.
Croatian: Svi su bolesnici imali najmanje 4 blage do umjerene lezije aktiničke keratoze na licu i/ili vlasištu.
English: The gel should be allowed to dry for approximately 10 minutes, before a light-tight dressing is placed over the treatment site.
Croatian: Gel treba ostaviti da se osuši približno 10 minuta prije postavljanja laganog zavoja na mjesto liječenja.
English: • Hypersensitivity to the active substance, to porphyrins, to soya or peanuts, or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar, na porfirine, na soju ili kikiriki ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Porfirija.
English: The efficacy of Ameluz in combination with daylight PDT was tested in a randomised, observer-blind, intra-individual phase III clinical trial enrolling 52 patients with 3-9 AKs on each side of the face and/ or scalp.
Croatian: Djelotvornost lijeka Ameluz u kombinaciji s fotodinamskom terapijom danjim svjetlom bila je ispitana u randomiziranom intraindividualnom kliničkom ispitivanju faze III maskiranom za ispitivače koje je uključilo 52 bolesnika s 3-9 lezija AK-a na svakoj strani lica i/ili vlasišta.
English: Ameluz does not increase 5-aminolaevulinic acid or protoporphyrin IX plasma levels following topical application.
Croatian: Ameluz ne povećava razine 5-aminolevulinatne kiseline ili protoporfirina IX u plazmi nakon topikalne primjene.
English: Ameluz contains soybean phosphatidylcholine and should not be applied to patients known to be allergic to peanut or soya (see section 4.3).
Croatian: Ameluz sadrži sojin fosfatidilkolin te se ne smije primjenjivati u bolesnika s poznatom alergijom na kikiriki ili soju (vidjeti dio 4.3).
English: Alemanha / Nemčija / Nemecko, Tél / Tel: / Teл.
Croatian: Tél / Tel: / Teл.
English: In rare cases, the adverse reactions required interruption or discontinuation of the illumination.
Croatian: U rijetkim je slučajevima zbog nuspojava bio potreban prekid ili prestanak osvjetljavanja.