FrancophonIA/ELRC3.0 huggingface dataset:
English: After Ameluz treatment, 6.2% of the lesions were recurrent after 6 and additionally 2.9% after 12 months, respectively (placebo: 1.9% after 6 and additionally 0% after 12 months, respectively).
Slovenian: Po zdravljenju z zdravilom Ameluz se je ponovno pojavilo 6,2 % lezij po 6 ter dodatna 2,9 % po 12 mesecih (placebo: 1,9 % po 6 in dodatnih 0 % po 12 mesecih).
English: Eyelid oedema, vision blurred, visual impairment
Slovenian: Edem vek, zamegljeni vid, okvara vida
English: Basal cell carcinoma lesions shall be evaluated three months after last treatment.
Slovenian: Lezije bazalnoceličnega karcinoma je treba oceniti tri mesece po zadnjem zdravljenju.
English: Risk of mucous membrane and eye irritation
Slovenian: Tveganje draženja sluznice in oči
English: One outer carton containing one aluminium tube with epoxyphenol inner lacquer and a latex seal and a screw cap of high density polyethylene.
Slovenian: Ena škatla vsebuje eno aluminijasto tubo z notranjim zaščitnim fenol-epoksi lakom, zaporko iz lateksa in navojnim pokrovčkom iz polietilena visoke gostote.
English: Treated lesions that have not completely resolved after 3 months shall be retreated.
Slovenian: Zdravljene lezije, ki po 3 mesecih niso povsem izginile, je treba ponovno zdraviti.
English: • Hypersensitivity to the active substance, to porphyrins, to soya or peanuts, or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na učinkovino, porfirine, sojo ali arašide, ali katero koli pomožno snov,
English: • medicines to treat mental disorders, nausea or vomiting with active substance names mostly ending in “azine”, such as phenothiazine
Slovenian: • zdravila za zdravljenje psihičnih bolezni, siljenja na bruhanje ali bruhanja z učinkovino, katere ime se večinoma konča z „azin“, kot je fenotiazin
English: Ameluz is for cutaneous use.
Slovenian: Zdravilo Ameluz je za dermalno uporabo.
English: The complete lesion clearance rate for Ameluz in combination with a single daylight PDT was 79.8%, compared to 76.5% for comparator MAL.
Slovenian: Stopnja popolnega očistka lezij za zdravilo Ameluz v kombinaciji z enkratno uporabo PDT z dnevno svetlobo je bila 79,8 %, v primerjavi s 76,5 % za MAL v obliki kreme.
English: Actinic keratosis lesion severity was graded according to the scale described by Olsen et al., 1991 (J Am Acad Dermatol 1991; 24: 738-743):
Slovenian: Resnost lezij aktinične keratoze se je ocenjevala v skladu z lestvico po Olsenu et al., 1991 (J Am Acad
English: Ameluz 78 mg/g gel 5-aminolaevulinic acid
Slovenian: Ameluz 78 mg/g gel 5-aminolevulinska kislina
English: 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.
Slovenian: Osvetlitev z uporabo dnevne svetlobe za zdravljenje aktinične keratoze Če so vremenski pogoji ustrezni (glejte zgoraj; Pomembni napotki pred zdravljenjem), pojdite ven 30 minut po nanosu gela in ostanite na polni dnevni svetlobi 2 neprekinjeni uri.
English: The gel should not be wiped off during the entire daylight PDT.
Slovenian: Gela ni dovoljeno obrisati med celotnim časom PDT z uporabo dnevne svetlobe.
English: During the post-marketing phase 20 cases indicative of application site hypersensitivity have been received for Ameluz.
Slovenian: V fazi analize med obdobjem trženja je bilo za zdravilo Ameluz prejetih 20 primerov, ki kažejo na preobčutljivost na mestu uporabe.
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:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za 5-aminolevulinsko kislino (keratozo), je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: • slightly palpable to moderately thick actinic keratoses on the face and scalp or entire fields affected by actinic keratoses in adults.
Slovenian: • rahlo otipljivih do zmerno debelih aktiničnih keratoz na obrazu in lasišču ali celotnih poljih,
English: 96.9 % of patients with AK on the face or forehead were cleared from all lesions, 81.8 % of patients with AK on the scalp were totally cleared.
Slovenian: bolnikih z AK na obrazu ali čelu so izginile vse lezije, pri 81,8 % bolnikov z AK na lasišču so izginile popolnoma.
English: Treatment of lesions or fields of actinic keratoses and basal cell carcinoma using a red-light lamp
Slovenian: Zdravljenje polj ali lezij aktinične keratoze in bazalnoceličnega karcinoma z uporabo svetilke z rdečo svetlobo
English: Following topical application of 5-aminolaevulinic acid (ALA), the substance is metabolized to protoporphyrin IX, a photoactive compound which accumulates intracellularly in the treated actinic keratosis and basal cell carcinoma lesions.
Slovenian: Po topikalni uporabi 5-aminolevulinske kisline (ALA-aminolaevulinic acid) se učinkovina presnavlja v protoporfirin IX, fotoaktivno spojino, ki se kopiči v celicah zdravljenih lezij aktinične keratoze in bazalnoceličnega karcinoma .
English: MAL Patient number n (%)
Slovenian: MAL Število bolnikov n (%)
English: Ameluz was superior to placebo with respect to patient complete clearance rates (90.9% vs. 21.9% for Ameluz and placebo, respectively; p < 0.0001) and lesion complete clearance rates (94.3% vs. 32.9%, respectively; p < 0.0001), as controlled 12 weeks after the last PDT.
Slovenian: Zdravilo Ameluz je bilo superiorno v primerjavi s placebom glede na stopnje popolnega izginotja (90,9 % za zdravilo Ameluz v primerjavi z 21,9 % za placebo; p < 0,0001) in stopnje popolnega izginotja lezij (94,3 % v primerjavi z 32,9 %; p < 0,0001), pri nadzoru po 12 tednih po zadnji PDT.
English: Do not wipe off the gel during the entire daylight treatment session.
Slovenian: Gela ne obrišite med celotnim trajanjem zdravljenja z uporabo dnevne svetlobe.
English: The red light source provided a narrow spectrum around 635 nm at a light dose of 37 J/cm2 (BF-RhodoLED).
Slovenian: Uporabili so vir rdeče svetlobe ozkega spektra z valovno dolžino okoli 635 nm in odmerkom svetlobe 37 J/cm2 (BF-RhodoLED).
English: Table 1: Summary of related adverse drug reactions (ADRs) reported in patients treated with photodynamic therapy with 5-aminolaevulinic acid System organ class
Slovenian: Preglednica 1: povzetek povezanih neželenih učinkov, o katerih so poročali pri bolnikih, ki so prejemali fotodinamično zdravljenje s 5-aminolevulinsko kislino
English: a) Preparation of the lesions: Before administration of Ameluz, all lesions should be carefully wiped with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin.
Slovenian: a) Priprava lezij: pred uporabo zdravila Ameluz je treba temeljito vse lezije previdno obrisati z bombažno blazinico, navlaženo z etanolom ali izopropanolom, da se koža razmasti.
English: NAME OF THE MEDICINAL PRODUCT Ameluz 78 mg/g gel
Slovenian: IME ZDRAVILA Ameluz 78 mg/g gel
English: a) Considerations before treatment: Daylight treatment should only be used if the conditions are suitable to stay comfortably outdoors for two hours (with temperatures > 10 °C).
Slovenian: a) Pomembni napotki pred zdravljenjem: zdravljenje z dnevno svetlobo se uporablja samo, če so pogoji primerni za udobno počutje na prostem dve uri (pri temperaturah > 10 °C).
English: The light dose delivered should be monitored if a suitable detector is available.
Slovenian: Če je na voljo ustrezen detektor, je treba uporabljeni odmerek svetlobe nadzorovati.
English: In rare cases, the adverse reactions required interruption or discontinuation of the illumination.
Slovenian: V redkih primerih je zaradi neželenih učinkov potrebna prekinitev ali prenehanje osvetlitve.
English: A broader and continuous spectrum may be used if narrow-spectrum light sources are not tolerated (see sections 4.8 and 5.1).
Slovenian: Če bolnik ne prenaša vira svetlobe ozkega spektra, se lahko uporabi svetloba širšega in kontinuiranega spektra (glejte poglavji 4.8 in 5.1).
English: The gel should cover the lesions or entire fields and approximately 5 mm of the surrounding area.
Slovenian: Gel mora pokrivati lezije ali celotno polje ter približno 5 mm okoliškega območja.
English: No experience exists for the use of Ameluz in patients with inherited or acquired coagulation defects.
Slovenian: Ni izkušenj z uporabo zdravila Ameluz pri bolnikih z dednimi ali pridobljenimi motnjami strjevanja krvi.
English: Treatment of AK and field cancerization with daylight:
Slovenian: Zdravljenje AK in polj s kancerizacijo z uporabo dnevne svetlobe:
English: Nervousness
Slovenian: Živčnost
English: Clearance rates and tolerability were dependent on the illumination source.
Slovenian: Stopnja odstranitve lezij in zmožnost prenašanja zdravljenja sta bili odvisni od vira osvetlitve.
English: Lesion recurrence rates after 6 and 12 months were 2.9% and 6.7%, respectively, for Ameluz, and 4.3% and 8.2% for MAL.
Slovenian: 12 mesecih 2,9 % in 6,7 % za zdravilo Ameluz oz. 4.3 % in 8,2 % za MAL.
English: In a phase II clinical trial, 5-aminolaevulinic acid and protoporphyrin IX serum levels and ALA urine levels were measured before, 3 and 24 hours after administration of Ameluz for photodynamic treatment.
Slovenian: V fazi II kliničnega preskušanja so izmerili ravni 5-aminolevulinske kisline in protoporfirina IX v serumu in ALA v urinu, in sicer pred uporabo zdravila Ameluz pri fotodinamičnem zdravljenju ter
English: Treated lesions or fields that have not completely resolved after 3 months shall be retreated.
Slovenian: Zdravljene lezije ali polja kancerizacije, ki po 3 mesecih niso povsem izginila, je treba ponovno zdraviti.
English: Taking shelter in the shade in hot weather is acceptable.
Slovenian: V vročem vremenu se lahko umaknete v senco.
English: Prior to the decision to undergo photodynamic therapy it should be taken into consideration that the probability of a subject to be completely cleared 12 months after the last treatment was 67.5% or 46.8% for treatment with Ameluz with narrow spectrum lamps or all lamp types, respectively.
Slovenian: Pred sprejetjem odločitve o izvedbi fotodinamičnega zdravljenja je treba upoštevati dejstvo, da je bila verjetnost, da bo bolnik 12 mesecev po zadnjem zdravljenju očiščen, 67,5- ali 46,8-odstotna pri zdravljenju z zdravilom Ameluz s svetilkami ozkega spektra oziroma s svetilkami vseh vrst.
English: Patient recurrence rates were 24.5 % and 14.3 % after 6 months, and additionally 12.2 % and 0 % after 12 months for Ameluz and placebo, respectively.
Slovenian: Stopnje ponovnega pojava pri bolnikih so bile po 6 mesecih za zdravilo Ameluz 24,5 % in 14,3 % za placebo in po 12 mesecih dodatnih 12,2 % za zdravilo Ameluz in 0 % za placebo.
English: If the time outdoors is interrupted, you should compensate this with a longer illumination time.
Slovenian: Prekinitev časa na prostem morate nadomestiti z daljšim časom osvetlitve.
English: Each carton contains one aluminium tube with 2 g gel closed with a polyethylene screw cap.
Slovenian: Ena škatla vsebuje eno aluminijasto tubo z 2 g gela in je zaprta s polietilenskim navojnim pokrovčkom.
English: 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.
Slovenian: Izogibati se je treba morebitnemu stiku z očmi, nosnicami, usti, ušesi, sluznico ali krvavečim lezijam pri čemer ohranite razdaljo najmanj 1 cm.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ameluz 78 mg/g gel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ameluz 78 mg/g gel
English: d) Illumination using daylight for AK treatment: If conditions are suitable (see section a. Considerations before treatment), patients shall go outside within 30 minutes after application of the gel and stay for 2 continuous hours in full daylight.
Slovenian: d) Osvetlitev z uporabo dnevne svetlobe za zdravljenje AK: če so pogoji ustrezni (glejte poglavje a. Pomembni napotki pred zdravljenjem), naj gredo bolniki ven 30 minut po nanosu gela in ostanejo na polni dnevni svetlobi 2 neprekinjeni uri.
English: Total lesion clearance rates were higher for Ameluz (90.4%) compared to MAL (83.2%) and placebo (37.1%).
Slovenian: Skupna stopnja odstranitve lezij je bila pri zdravilu Ameluz (90,4 %) v primerjavi z MAL (83,2 %) in s placebom (37,1 %) višja.
English: Direct contact of Ameluz with the eyes or mucous membrane should be avoided.
Slovenian: Treba se je izogibati neposrednemu stiku oči ali sluznice z zdravilom Ameluz.
English: What Ameluz contains
Slovenian: Zdravilo Ameluz vsebuje
English: Furthermore, a publication was identified reporting on occurrence of contact dermatitis after treatment with 5-aminolevulinic acid or methyl-aminolevulinic acid.
Slovenian: Nadalje obstaja objava, v kateri poročajo o pojavu kontaktnega dermatitisa po zdravljenju s 5
English: In this study, photodynamic therapy with Ameluz was tested for non-inferiority to a cream containing 16% methyl-aminolevulinate (MAL, methyl-[5-amino-4oxopentanoate]).
Slovenian: V tej študiji se je fotodinamično zdravljenje z zdravilom Ameluz pokazalo za enakovredno z zdravilom v obliki kreme, ki vsebuje 16 % metil aminolevulinata (MAL, metil-[5-amino-4-oksopentanoat]).
English: Breast-feeding should be discontinued for 12 hours after treatment with Ameluz.
Slovenian: Po zdravljenju z zdravilom Ameluz je treba za 12 ur prenehati z dojenjem.
English: Propylene glycol may cause irritation.
Slovenian: Propilenglikol lahko povzroči draženje.
English: Xanthan gum, soybean phosphatidylcholine, polysorbate 80, triglycerides medium-chain, isopropyl alcohol, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, propylene glycol, sodium benzoate (E211), purified water.
Slovenian: Ksantanski gumi, sojin fosfatidilholin, polisorbat 80, srednjeverižni trigliceridi, izopropil alkohol, natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, propilenglikol, natrijev benzoat (E211), prečiščena voda.
English: The probability of patients in the Ameluz group to require only 1 treatment and remain completely cleared 12 months after the photodynamic therapy was 32.3%, that of patients in the MAL group 22.4% on average with all lamps.
Slovenian: Verjetnost, da bodo bolniki, ki so jih zdravili z zdravilom Ameluz, potrebovali samo eno zdravljenje in bodo 12 mesecev po fotodinamičnem zdravljenju povsem očiščeni, je bila 32,3odstotna, pri bolnikih, ki so se zdravili z MAL, pa je bila ta verjetnost v povprečju 22,4-odstotna pri uporabi vseh svetilk.
English: • Avoid sun exposure on the treated lesion sites and surrounding skin for approximately 48 hours following treatment.
Slovenian: • Zdravljenih lezij in kože okrog njih ne izpostavljajte soncu približno 48 ur po zdravljenju.
English: 5-aminolaevulinic acid
Slovenian: 5-aminolevulinska kislina Dermalna uporaba
English: PPS - non-inferiority 49 79.8 +/- 23.6 49 76.5 +- 26.5 FAS - superiority 51 78.7 +/- 25.8 51 75.0 +/- 28.1
Slovenian: PPS - enakovrednost 49 79,8 +/- 23,6 49 76,5 +- 26,5 FAS - superiornost
English: Total lesion clearance was higher for Ameluz (81.1%) compared to placebo (20.9%).
Slovenian: Skupna stopnja odstranitve lezij je bila pri zdravljenju z zdravilom Ameluz (81,1 %) večja kot pri placebu (20,9 %).
English: The excipient sodium benzoate may be mildly irritant to the skin, eyes and mucous membranes.
Slovenian: Pomožna snov natrijev benzoat lahko povzroči blago draženje kože, oči in sluznice.
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.
Slovenian: Pri večini bolnikov so opazili do 2,5-kratno povečanje osnovnih koncentracij ALA v plazmi v prvih 3 urah po nanosu zdravila Ameluz, kar je še vedno v normalnem razponu predhodno poročanih in objavljenih endogenih koncentracij ALA. Koncentracije presnovka PpIX v plazmi so bile na splošno nizke pri vseh bolnikih in pri nobenem od bolnikov niso opazili očitnega povečanja koncentracij PpIX v plazmi po nanosu zdravila Ameluz.
English: A narrow spectrum lamp is recommended to achieve higher clearance rates.
Slovenian: Za doseganje hitrejše odstranitve lezij se priporoča uporaba svetilke ozkega spektra.
English: • 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
Slovenian: − 5-aminolevulinsko kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: Clearance rates and tolerability were dependent on the illumination source in favour of the narrow spectrum light source.
Slovenian: Stopnja odstranitve lezij in zmožnost prenašanja zdravljenja sta bili odvisni od vira osvetlitve, pri čemer so bili rezultati boljši pri viru svetlobe ozkega spektra.
English: confusion and disorientation*, Dysaesthesia
Slovenian: Prehodna popolna amnezijo (vključno z zmedenostjo in dezorientacijo)*, disestezija
English: The study of Ameluz using daylight showed similar types of side effects; however, with lower intensity.
Slovenian: Študija o zdravilu Amleuz z uporabo dnevne svetlobe je pokazala podobne neželene učinke,
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier.
Slovenian: Dvodimenzionalna črtna koda z edinstveno oznako.
English: The primary endpoint was complete patient clearance 12 weeks after the last photodynamic therapy.
Slovenian: Primarna končna točka je bila popolna odstranitev lezij bolnikov 12 tednov po zadnjem fotodinamičnem zdravljenju.
English: As a general precaution, sun exposure on the treated lesion sites and surrounding skin should be avoided for approximately 48 hours following treatment.
Slovenian: Iz previdnosti se zdravljenih lezij in kože okrog njih 48 ur po zdravljenju ne sme izpostavljati soncu.
English: Discard open tubes 12 weeks after opening.
Slovenian: Tube zavrzite 12 tednov po prvem odprtju.
English: Medicinal product
Slovenian: PROMET Z ZDRAVILOM
English: Moderate/ severe Scarring None Mild
Slovenian: Zmerna/resna Brazgotinjenje Brez Blaga
English: Rainy periods or time required indoors prolonged the outdoor exposure accordingly.
Slovenian: Čas deževnih obdobij ali čas, ki so ga bolniki preživeli v zaprtih prostorih, so nadomestili s podaljšanjem izpostavljenosti na prostem.
English: In a randomised, observer blinded clinical trial with 571 AK patients and a follow-up duration of 6 and 12 months, photodynamic therapy with Ameluz was tested for non-inferiority to a commercially registered cream containing 16% methyl-aminolevulinate (MAL, methyl-[5-amino-4-oxopentanoate]) and superiority over placebo.
Slovenian: 571 bolnikov z AK in v nadaljnjem spremljanju v obdobju od šest do dvanajst mesecev so preverjali enakovrednost fotodinamičnega zdravljenja z zdravilom Ameluz z zdravilom z dovoljenjem za promet v obliki kreme, ki vsebuje 16 % metil-aminolevulinata (MAL, metil-[5-amino-4-oksopentanoat]) in superiornost zdravila Ameluz v primerjavi s placebom.
English: • Avoid applying Ameluz
Slovenian: • Izogibajte se nanosu zdravila Ameluz
English: After only 1 PDT complete patient clearance resulted in 61.8 % vs. 9.4 %, and complete lesion clearance in 84.2 % vs. 22.0 % for Ameluz and placebo treatment, respectively.
Slovenian: Po le eni PDT je bilo popolno izginotje pri bolnikih 61,8 % v primerjavi z 9,4 % za placebo in kompletno izginotje lezij pri 84,2 % za zdravilo Ameluz v primerjavi z 22,0 % za placebo.
English: The following table presents the efficacy and the adverse reactions transient pain and erythema occurring at the application site during photodynamic therapy with different light sources:
Slovenian: V spodnji preglednici so predstavljeni učinkovitost in neželeni učinki v obliki prehodne bolečine in eritema, ki sta se pojavila na mestu nanosa med fotodinamičnim zdravljenjem z različnimi viri svetlobe:
English: Adverse reaction
Slovenian: − druge reakcije
English: Ameluz can cause mucous membrane or eye irritation.
Slovenian: Zdravilo Ameluz lahko povzroči draženje sluznice ali oči.
English: The red light source provided either a narrow spectrum around 630 nm at a light dose of 37 J/cm2 (Aktilite CL 128) or a broader and continuous spectrum in the range between 570 and 670 nm at a light dose of 170 J/cm2 (Photodyn 750).
Slovenian: Vir rdeče svetlobe je zagotovil bodisi ozek spekter z valovno dolžino okoli 630 nm in odmerkom svetlobe 37 J/cm2 (Aktilite CL 128) bodisi širši in kontinuirani spekter z valovno dolžino v razponu od 570 do 670 nm in odmerkom svetlobe 170
English: The application site preparation and duration of incubation followed the description under section 4.2.
Slovenian: Priprava mesta nanosa in trajanje inkubacijske dobe sta opisana v poglavju
English: Talk to your doctor before using Ameluz.
Slovenian: Pred začetkom uporabe zdravila Ameluz se posvetujte z zdravnikom.
English: Clinical efficacy was maintained during the follow-up periods of 6 and 12 months after the last PDT.
Slovenian: Klinična učinkovitost se je ohranila v obdobju spremljanja 6 in 12 mesecev po PDT.
English: There is no need to protect healthy untreated skin surrounding the treated actinic keratosis lesions.
Slovenian: Zdrave kože okrog lezij aktinične keratoze pri zdravljenju ni treba zaščititi.
English: What you need to know before you use Ameluz
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ameluz Ne uporabljajte zdravila Ameluz:
English: Any bleeding must be stopped before application of the gel.
Slovenian: Krvavitev je treba ustaviti pred nanosom gela.
English: Pelpharma Handels GmbH Tel: +43 2273 70 080 ameluz@pelpharma.at
Slovenian: Pelpharma Handels GmbH Tel: +43 2273 70 080
English: - swelling
Slovenian: − zatrdline
English: • Basal cell carcinoma is treated with two sessions, with an interval of one week between sessions.
Slovenian: • Za zdravljenje bazalnoceličnega karcinoma sta potrebni dve zdravljenji z enotedenskim intervalom med njima.
English: Broad spectrum
Slovenian: Široki spekter
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.
Slovenian: Ameluz za vse podskupine pediatrične populacije pri aktinični keratozi.
English: Apply sunscreen to sun exposed skin for sun protection 15 min before lesion treatment.
Slovenian: 15 min pred obdelavo lezije nanesite sredstvo za zaščito kože, ki je izpostavljena soncu, pred UV
English: Care should be taken to avoid bleeding.
Slovenian: Treba je paziti, da preprečite krvavitev.
English: 2 moderate pink to reddish papules and erythematous plaques with hyperkeratotic surface, moderately thick AK that are easily seen and felt
Slovenian: 1 blaga ploščati, rožnati madeži brez znakov hiperkeratoze in eritema, rahlo se občutijo, pri aktinični keratozi so bolj otipljivi kot vidni 2 zmerna rožnate do rdečkaste papule in eritematozni plak s hiperkeratozno površino, zmerno odebeljena aktinična keratoza, ki se opazi in občuti
English: Narrow spectrum
Slovenian: Ozki spekter
English: Clinical efficacy was re-assessed at follow-up visits 6 and 12 months after the last photodynamic therapy.
Slovenian: Klinično učinkovitost so ponovno ocenili ob obiskih v nadaljnjem spremljanju po 6 in 12 mesecih po zadnjem fotodinamičnem zdravljenju.
English: - into eyes or to mucous membranes
Slovenian: − na krvaveče lezije, − v oči ali na sluznice,
English: c) Application of the gel: A thin layer of Ameluz should be applied to the lesion area or entire cancerized fields using glove protected fingertips or a spatula.
Slovenian: c) Nanašanje gela: zdravilo Ameluz je treba s prsti, zaščitenimi z rokavico, ali z lopatico nanesti na celotno površino lezij ali celotno polje kancerizacije.
English: N MAL Mean + SD (%)
Slovenian: Povprečna vrednost + SD
English: White to yellowish gel.
Slovenian: Zdravilo Ameluz je belo rumenkast gel.