FrancophonIA/ELRC3.0 huggingface dataset:
English: These factors vary with lamp type.
Slovenian: Ti dejavniki se razlikujejo glede na vrsto svetilke.
English: - change of colour
Slovenian: − sprememba barve
English: * Data from post-marketing period.
Slovenian: * Podatki iz obdobja trženja.
English: Ameluz daylight photodynamic therapy is feasible all year long in southern Europe, from February to October in middle Europe, and from March to October in northern Europe.
Slovenian: Fotodinamično zdravljenje z zdravilom Ameluz z uporabo dnevne svetlobe je v južni Evropi mogoče vse leto, v srednji Evropi od februarja do oktobra, v severni Evropi pa od marca do oktobra.
English: 1 This reaction also occurs before illumination.
Slovenian: 1 Ta reakcija se pojavi tudi pred osvetlitvijo.
English: • In very rare cases photodynamic therapy may increase the risk of developing temporary memory loss.
Slovenian: • V zelo redkih primerih lahko fotodinamično zdravljenje poveča tveganje razvoja začasne izgube spomina.
English: Your doctor will decide how well each skin lesion has responded, and treatment may have to be repeated at this time.
Slovenian: Zdravnik bo presodil, kako dobro se je posamezna kožna lezija odzvala, in morda bo tokrat zdravljenje treba ponoviti.
English: Thus, it seems not plausible that this could negatively impact the non-inferiority claim of the primary study endpoint or the general trends observed across all subgroups.
Slovenian: Zato se ne zdi verodostojno, da bi lahko to negativno vplivalo na trditev o enakovrednosti cilja študije ali splošnih trendov, ki so jih opazili v vseh podskupinah.
English: • reactions at the application site
Slovenian: • reakcije na mestu uporabe
English: • Porphyria.
Slovenian: • Porfirija.
English: Date of latest renewal: 21 November 2016
Slovenian: Datum prve odobritve: 14. december 2011 Datum zadnjega podaljšanja: 21. november 2016
English: Protection from sun light exposure for 48 hours and observation are nevertheless recommended.
Slovenian: Kljub temu se priporočata 48-urna zaščita pred izpostavljenostjo soncu in opazovanje.
English: Each lamp should be used according to the user manual.
Slovenian: Vsaka svetilka se mora uporabljati v skladu s priročnikom za uporabo.
English: In the presence of oxygen, reactive oxygen species are formed.
Slovenian: V prisotnosti kisika se oblikujejo reaktivne kisikove spojine.
English: In conclusion, even though subgroup sizes are too small to draw significant conclusions on individual groups, the distribution of the two products to the relevant subgroups is very similar.
Slovenian: Sklepamo lahko, da je kljub premajhnim velikostim podskupin za pomembna sklepanja o posamičnih skupinah, porazdelitev obeh zdravil v vsakokratne podskupine zelo podobna.
English: Some reactions at the application site have been observed before the use of light.
Slovenian: Nekatere reakcije na mestu uporabe so opazili pred uporabo svetlobe.
English: - on skin areas affected by other diseases or tattoos, because this may hinder the success and assessment of the treatment.
Slovenian: − na dele kože, prizadete zaradi drugih bolezni, ali na tetovaže, saj lahko to ovira uspeh in oceno zdravljenja.
English: In 12 cases the reactions started before illumination.
Slovenian: V 12 primerih se je reakcija začela pred osvetlitvijo.
English: Protoporphyrin IX is activated by illumination with red light of a suitable wavelength and energy.
Slovenian: Protoporfirin IX se aktivira z osvetlitvijo z rdečo svetlobo primerne valovne dolžine in energije.
English: There is no need to protect healthy untreated skin.
Slovenian: Zaščita zdrave, nezdravljene kože ni potrebna.
English: Immediately after cleaning, the entire treated area is illuminated using a red light source.
Slovenian: Takoj po čiščenju se celotno zdravljeno območje osvetli z uporabo vira rdeče svetlobe.
English: Number of treatments
Slovenian: Število zdravljenj
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.
Slovenian: Porazdelitev bolnikov v podskupinah je bila podobna za obe zdravili in predstavlja porazdelitev v splošni populaciji, pri čemere je več kot 70 % BCC na predelu glave/trupa.
English: The intensity of these effects is dependent on the type of illumination used for photodynamic therapy.
Slovenian: Intenzivnost teh učinkov je odvisna od vrste osvetlitve, uporabljene za fotodinamično zdravljenje.
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.
Slovenian: Uporabljeni odmerek svetlobe se določi na osnovi dejavnikov, kot so velikost svetlobnega polja, razdalja med svetilko in površino kože ter čas osvetljevanja.
English: Although the exact mechanism is not known, stress and pain associated with PDT may increase the risk to develop transient amnesia.
Slovenian: Čeprav natančni mehanizem ni znan, lahko stres in bolečina, povezana s fotodinamičnim zdravljenjem, povečata tveganje za razvoj prehodne amnezije.
English: Actinic keratoses and basal cell carcinomas do not occur in children and adolescents, except in extremely rare cases.
Slovenian: Aktinične keratoze in bazalnocelični karcinomi se pri otrocih in mladostnikih ne pojavljajo, razen v zelo redkih primerih.
English: Remaining gel will be removed after completion of light exposure.
Slovenian: Preostali gel bo odstranjen po zaključku osvetlitve.
English: A distance of at least 1 cm is to be maintained.
Slovenian: Nanašajte vsaj 1 cm od njih.
English: Special care should be taken to avoid bleeding during lesion preparation in such patients (see section 4.2).
Slovenian: Posebna pozornost je potrebna, da se prepreči krvavitev med pripravo lezije pri teh bolnikih (glejte poglavje 4.2).
English: • if you have other skin conditions caused by, or made worse by, exposure to light
Slovenian: • če imate druga kožna obolenja, ki jih povzroča ali poslabša izpostavljenost svetlobi
English: The dressing is removed after 3 hours.
Slovenian: Povoj odstranite po treh urah.
English: After 24 hours, the mean cumulative absorption (including accumulation in the dermis) through human skin was 0.2% of the administered dose.
Slovenian: Po 24 urah je bila povprečna skupna absorpcija (vključno s kopičenjem v povrhnjici) skozi človeško kožo 0,2 % uporabljenega odmerka.
English: Before PDT (%) 12 months after PDT (%)
Slovenian: 12 mesecev po PDT (%)
English: Use of immunosupressants
Slovenian: Uporaba imunosupresivov
English: • if you have impaired formation of red blood pigment called porphyria
Slovenian: • če imate obolenje, pri katerem je okvarjeno tvorjenje rdečega krvnega pigmenta, imenovano porfirija
English: 3 severe very thick and / or obvious AK
Slovenian: 3 huda zelo odebeljena in/ali očitna aktinična keratoza
English: Actinic keratoses are certain changes in the outer layer of the skin that can lead to skin cancer.
Slovenian: Aktinične keratoze so določene spremembe na zunanji plasti kože, ki lahko povzročijo kožnega raka.
English: It is important to ensure that the correct light dose is administered.
Slovenian: Pomembno je, da se zagotovi uporaba pravilnega odmerka svetlobe.
English: Clinical description of severity grading
Slovenian: Klinični opis stopnje resnosti
English: • soybean phosphatidylcholine: If you are allergic to peanut or soya, do not use this medicine.
Slovenian: • sojin fosfatidilholin: če ste alergični na arašide ali sojo, ne uporabljajte tega zdravila.
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.
Slovenian: Simptomi so običajno blagi ali zmerni (ocena raziskovalcev na štiristopenjski lestvici) in v večini primerov trajajo od enega do štirih dni; v nekaterih primerih lahko trajajo tudi en teden ali dva oziroma celo dlje.
English: The percentage of patients with skin impairment before PDT and 12 months after PDT is listed in the table below.
Slovenian: Odstotek bolnikov s prizadetostjo kože pred PDT in ter 12 mesecev po PDT je naveden v spodnji preglednici.
English: This therapy is known as photodynamic therapy (PDT).
Slovenian: To zdravljenje se imenuje fotodinamično zdravljenje (PDT- photodynamic therapy).
English: Blister, dry skin, petechiae
Slovenian: Mehurji, suha koža, petehije
English: Illumination with appropriate light produces reactive oxygen-containing molecules which act against the target cells.
Slovenian: Osvetlitev s primerno svetlobo proizvaja reaktivne molekule kisika, ki delujejo proti ciljnim celicam.
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.
Slovenian: Nobena raven po odmerjanju v primerjavi z naravno prisotnimi ravnmi pred odmerjanju ni bila povečana, kar kaže na odsotnost pomembne sistemske absorpcije po topikalni uporabi.
English: Carcinogenicity studies have not been performed with ALA.
Slovenian: Študije kancerogenosti z ALA niso bile izvedene.
English: Ameluz is only used on the skin.
Slovenian: Zdravilo Ameluz se uporablja samo na koži.
English: After more extended time periods, treatment with Ameluz frequently results in continued improvement of skin quality parameters.
Slovenian: Po daljšem obdobju je rezultat zdravljenja z zdravilom Ameluz pogosto stalno izboljšanje parametrov kakovosti kože.
English: Illumination using a red-light lamp
Slovenian: Osvetlitev z uporabo svetilke z rdečo svetlobo
English: Mottled or irregular pigmentation
Slovenian: Lisasta ali nepravilna pigmentacija
English: Nodular BCC lesions are often covered by an intact epidermal keratin layer which should be removed.
Slovenian: Lezije nodularnega BCC pogosto prekriva nepoškodovana plast epidermalnega keratina, ki jo je treba odstraniti.
English: On sunny days, shelter in the shade could be taken should the patient feel uncomfortable in direct sunlight.
Slovenian: Ob sončnih dneh je bilo dovoljeno zavetje v senci, v kolikor bolniku ni bilo udobno na neposredni sončni svetlobi.
English: Table 4: Efficacy of PDT for the treatment of BCC for all patients and selected subgroups Ameluz Patient number n (%)
Slovenian: Preglednica 4: Učinkovitost PDT za zdravljenje BCC za vse bolnike in izbrane podskupine Zdravilo Ameluz Število bolnikov n (%)
English: Ameluz should not be used on skin areas affected by other diseases or tattoos.
Slovenian: Zdravila Ameluz se ne sme uporabljati na predelih kože, ki so prizadeta zaradi drugih bolezni ali tetovirana.
English: It is recommended that the response of BCC lesions may be confirmed by histological examination of biopsy material, if considered necessary.
Slovenian: Priporoča se, da se odziv BCC lezij potrdi s histološkim pregledom materiala za biopsijo, če se to oceni kot potrebno.
English: Tube
Slovenian: TUBA
English: • rash, red or purple spots on the body
Slovenian: • izpuščaj, rdeči ali vijolični madeži na telesu
English: Subsequently, close long term clinical monitoring of BCC is recommended, with histology if necessary.
Slovenian: Nato se priporoča dolgotrajno klinično spremljanje BCC, po potrebi s histologijo.
English: During illumination the lamp should be fixed at the distance from the skin surface that is indicated in the user manual.
Slovenian: Med osvetlitvijo mora biti svetilka pritrjena na določeni razdalji od površine kože, ki je navedena v priročniku za uporabo.
English: Overdose following topical administration is unlikely and has not been reported in clinical studies.
Slovenian: Prekomerno odmerjanje pri topikalni uporabi je malo verjetno in o njem v kliničnih študijah niso poročali.
English: BCCs located in this region mainly belong to the superficial subtype.
Slovenian: BCC na tem predelu je večinoma površinskega podtipa.
English: Corresponding studies in human skin with actinic keratosis lesions and/or roughened surface were not performed.
Slovenian: Ustrezne študije na človeški koži z lezijami aktinične keratoze in/ali hrapavo površino niso bile izvedene.
English: During illumination, patient and medical personnel should wear suitable protective goggles.
Slovenian: Med osvetlitvijo morajo bolnik in zdravstveno osebje nositi ustrezna zaščitna očala.
English: BCC on the head (only)
Slovenian: BCC na glavi (samo) BCC na trupu (samo)
English: All skin quality parameters in the treated area continuously improved up to the 12-month follow-up time point.
Slovenian: Vsi parametri kakovosti kože zdravljenega predela so se stalno izboljševali do časovne točke 12-mesečnega spremljanja.
English: Most adverse reactions occur during illumination or shortly afterwards.
Slovenian: Največ neželenih učinkov se pojavi med osvetlitvijo ali kmalu po njej.
English: In this study a total of 138 patients were treated with Ameluz.
Slovenian: V tej študiji je bilo z zdravilom Ameluz skupaj zdravljenih 138 bolnikov.
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.
Slovenian: Zdravilo Ameluz se lahko daje samo pod nadzorom zdravnika, medicinske sestre ali drugega zdravstvenega delavca z izkušnjami z uporabo fotodinamičnega zdravljenja.
English: Exposed tumour material should be removed gently without any attempt to excise beyond the tumour margins.
Slovenian: Izpostavljen tumorski material je treba nežno odstraniti brez poskusa ekscizije čez mejo tumorja.
English: EXP Discard 12 weeks after first opening.
Slovenian: EXP Zavrzite 12 tedne po prvem odprtju.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Only CE marked lamps should be used, equipped with the necessary filters and/or reflecting mirrors to minimize exposure to heat, blue light and ultra violet (UV) radiation.
Slovenian: Uporabljajo se lahko samo svetilke z oznako CE, ki so opremljene s potrebnimi filtri in/ali odsevnimi ogledali za zmanjšanje izpostavljenosti toploti, modri svetlobi in ultravijoličnemu (UV) sevanju.
English: • The use of Ameluz is not recommended if you use immunosuppressants.
Slovenian: • Uporaba zdravila Ameluz ni priporočljiva, če uporabljate imunosupresive.
English: The table additionally includes serious adverse reactions reported post-marketing.
Slovenian: Preglednica dodatno vključuje tudi resne neželene učinke, o katerih so poročali v obdobju trženja.
English: Intensity of adverse reactions, particularly pain, was lower when Ameluz was used in combination with daylight PDT.
Slovenian: Intenzivnost neželenih učinkov, predvsem bolečine, je bila nižja ob uporabi zdravila Ameluz v kombinaciji s PDT z uporabo dnevne svetlobe.
English: If Ameluz is accidentally ingested, systemic toxicity is unlikely.
Slovenian: Če se zdravilo Ameluz nenamerno zaužije, je sistemska zastrupitev malo verjetna.
English: Efficacy and safety of Ameluz for the treatment of actinic keratosis (AK) has been evaluated in 696 patients enrolled in clinical trials.
Slovenian: Učinkovitost in varnost zdravila Ameluz za zdravljenje aktinične keratoze (AK) so ocenjevali pri 696 bolnikih, vključenih v klinična preskušanja.
English: Lesions should be re-assessed after three months, at which point any residual lesions or fields may be retreated.
Slovenian: Po treh mesecih je treba lezije ponovno oceniti, takrat se lahko preostale lezije ali polja tudi ponovno zdravijo.
English: Each tube contains 2 g of gel.
Slovenian: Ena tuba vsebuje 2 g gela.
English: Field cancerization is characterised by an area of skin where multiple AK lesions are present and there is likely to be an underlying and surrounding area of actinic damage (a concept known as field cancerization or field change); the extent of this area may not be evident visually or by physical examination.
Slovenian: Za polje kancerizacije je značilno območje kože, kjer je prisotnih več lezij AK in kjer se spodaj in okrog verjetno nahaja območje aktinične poškodbe (pojem, ki je poznan kot polje kancerizacije ali polje spremembe); obseg tega območja morda ni očiten z vizualnim ali fizičnim pregledom.
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.
Slovenian: Uspešnost in ocena zdravljenja sta lahko zmanjšana, če je zdravljeno območje prizadeto zaradi kožnih bolezni (vnetje kože, lokalne okužbe, psoriaza, ekcem in maligni rak kože) ali je tetovirano.
English: Generally, side effects are of mild or moderate intensity, typically occurring during illumination or 1 to 4 days after.
Slovenian: Neželeni učinki so na splošno blagi ali zmerni in se običajno pojavijo med osvetlitvijo ali en dan do štiri dni kasneje.
English: Hyperpigmentation
Slovenian: Hiperpigmentacija
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
Slovenian: Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1 000 do <1/100), redki (≥1/10 000 do <1/1 000), zelo redki (<1/10 000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The use of Ameluz requires specific knowledge in photodynamic therapy as it may necessitate the use of a red-light lamp.
Slovenian: Za uporabo zdravila Ameluz je potrebno strokovno znanje na področju fotodinamičnega zdravljenja, saj lahko zahteva uporabo svetilke z rdečo svetlobo.
English: Efficacy and side effects such as temporary pain are dependent on the light source used.
Slovenian: Učinkovitost in neželeni učinki, kot so prehodna bolečina, so odvisni od uporabljenega vira svetlobe.
English: Adverse events and tolerability were comparable for both treatments.
Slovenian: Neželeni učinki in prenašanje so bili primerljivi pri obeh zdravljenjih.
English: In clinical phase III, a total of 436 patients were treated with Ameluz.
Slovenian: V klinični fazi III je bilo z zdravilom Ameluz skupaj zdravljenih 436 bolnikov.
English: Table 3a: Skin quality parameters in the treated area during 12- month follow-up
Slovenian: Preglednica 3a: Parametri kakovosti kože zdravljenega predela med 12-mesečnim spremljanjem Tip prizadetosti kože
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.
Slovenian: Pred uporabo določenega vira svetlobe morate preveriti tehnične specifikacije naprave in zagotoviti, da so izpolnjene zahteve za želeni spekter svetlobe.
English: There is no relevant use of Ameluz in the paediatric population.
Slovenian: Ustrezne uporabe zdravila Ameluz pri pediatrični populaciji ni.
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.
Slovenian: Učinkovitost zdravila Ameluz v kombinaciji s PDT z uporabo dnevne svetlobe je bila preskušena v randomiziranem intra-individualnem kliničnem preskušanju s slepim opazovalcem, faze III, v katerega je bilo vključenih 52 bolnikov s 3-9 mesti z AK na vsaki strani obraza in/ali na lasišču.
English: All patients had 1 to 3 BCC lesions on the face/forehead, bald scalp, extremities and/or neck/trunk.
Slovenian: Vsi bolniki so imeli 1 do 3 lezije BCC na obrazu ali čelu, plešastem lasišču, okončinah in/ali vratu/trupu.
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.
Slovenian: Bazalnocelični karcinom je kožni rak, ki lahko povzroča rdečkaste, luskinaste zaplate ali eno ali več majhnih bulic, ki hitro krvavijo in se ne zacelijo.
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.
Slovenian: Zdravljenje blage do zmerne aktinične keratoze na obrazu in lasišču (stopnje 1 do 2 po Olsenu; glejte poglavje 5.1) in polja kancerizacije pri odraslih.
English: The most common signs and symptoms are application site irritation, erythema, pain, and oedema.
Slovenian: Najpogostejši znaki in simptomi so draženje na mestu uporabe, eritem, bolečina in edem.
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).
Slovenian: V obeh študijah AK so bile stopnje odstranitve lezij večje po osvetlitvi z napravami s svetlobo ozkega spektra, vendar pa sta se pojavnost in intenzivnost motenj na mestu nanosa (npr. prehodna bolečina, eritem) povečali pri bolnikih, osvetljenih s temi napravami (glejte preglednico zgoraj in poglavje 4.8).
English: If not completely cleared 12 weeks after initial treatment, lesions or cancerized fields were treated a second time with an identical regimen.
Slovenian: Če 12 tednov po prvem zdravljenju lezije ali polja kancerizacije niso popolnoma izginili, so jih na enak način zdravili še enkrat.
English: After the two hour light exposure, wash off the remaining gel.
Slovenian: Po dvourni izpostavljenosti svetlobi sperite preostali gel.
English: Photodynamic therapy with Ameluz (66.3%) was significantly more effective than with placebo (12.5%, p < 0.0001).
Slovenian: Fotodinamično zdravljenje z zdravilom Ameluz (66,3 %) je bilo bistveno učinkovitejše kot zdravljenje s placebom (12,5 %, p < 0,0001).
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.
Slovenian: To je pričakovano, saj terapevtsko načelo fotodinamičnega zdravljenja temelji na fototoksičnih učinkih protoporfirina IX, ki se sintetizira iz učinkovine 5-aminolevulinske kisline.
English: Keep the tube tightly closed after first opening.
Slovenian: Po prvem odprtju tubo shranjujte tesno zaprto.
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.
Slovenian: Neželeni učinki na mestu nanosa gela se pojavijo pri okoli 9 od 10 bolnikov in kažejo, da se prizadete celice odzivajo na zdravljenje.
English: Unopened tube: 18 months After first opening: 12 weeks
Slovenian: Neodprta tuba: 18 mesecev
English: The increased effects correlate with the higher clearance rate of narrow spectrum lamps (see section 5.1).
Slovenian: Povečani učinki so sorazmerni z višjo hitrostjo odstranitve lezij pri svetilkah ozkega spektra (glejte poglavje 5.1).
English: Both the patient and the medical personnel conducting the photodynamic therapy should adhere to any safety instructions provided with the light source used.
Slovenian: Tako bolnik kot zdravstveno osebje, ki izvaja fotodinamično zdravljenje, morajo upoštevati vsa varnostna navodila, priložena uporabljenemu viru svetlobe.