FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of the randomised and blinded second treatment course are presented in table 6.
Slovenian: Rezultati randomiziranega in slepega drugega kroga zdravljenja so predstavljeni v preglednici 6.
English: Take care not to transfer gel from the treatment area into your eyes.
Slovenian: Pazite, da ne prenesete gela z zdravljenega predela v oči.
English: Efficacy, measured as complete and partial clearance rate, as well as median percent reduction, was assessed at day 57 (see table 2).
Slovenian: Učinkovitost, izmerjena kot popolna in delna ozdravitev lezij, in mediano odstotno zmanjšanje sta bila ocenjena 57. dan (glejte preglednico 2).
English: - Be vigilant for any new scaly red patches, open sores, elevated or warty growths within the treatment area.
Slovenian: - Bodite pozorni na morebitne nove luskaste rdeče zaplate, odprte rane, dvignjene ali bradavičaste tvorbe na zdravljenem mestu.
English: Actinic keratoses are rough areas of skin found in people who have been exposed to too much sunshine over the course of their lifetime.
Slovenian: Aktinična keratoza so predeli grobe kože pri ljudeh, ki so bili v življenju čezmerno izpostavljeni sončnim žarkom.
English: Should any occur, talk to your doctor immediately.
Slovenian: Če se pojavijo, se takoj posvetujte z zdravnikom.
English: If an area on the face or scalp and another area on the trunk or extremities are simultaneously treated, then patients should be advised to ensure they use the appropriate strengths.
Slovenian: Če se zdravi mesto na obrazu, lasišču in drugem področju trupa ali okončin istočasno, je treba bolnikom svetovati, da uporabljajo zdravilo ustrezne jakosti.
English: Only those patients who achieved complete clearance in the treated area at the end of the phase 3 studies (day 57) were eligible for long term follow-up.
Slovenian: Samo bolniki, pri katerih se je pojavila popolna ozdravitev lezij na zdravljenem mestu ob koncu študij 3. faze (57. dan), so izpolnjevali pogoje za dolgoročno spremljanje.
English: These results did not change the safety profile of Picato (see section 5.1).
Slovenian: Ti rezultati niso spremenili varnostnega profila zdravila Picato (glejte poglavje 5.1).
English: What you need to know before you use Picato Do not use Picato
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Picato Ne uporabljajte zdravila Picato
English: Caps of HDPE.
Slovenian: Pokrovčki iz HDPE.
English: For single use only Read the package leaflet before use.
Slovenian: Samo za enkratno uporabo Pred uporabo preberite priloženo navodilo!
English: On each scheduled dosing day, the study gel was applied to the entire treatment area.
Slovenian: Vsak predviden dan odmerjanja so proučevani gel nanesli na celotno prizadeto mesto.
English: Paediatric population There is no relevant use of Picato in the paediatric population.
Slovenian: Pediatrična populacija Zdravilo Picato ni primerno za uporabo pri pediatrični populaciji.
English: Optimal therapeutic effect can be assessed approximately 8 weeks after treatment.
Slovenian: Optimalne učinke zdravljenja je mogoče oceniti približno 8 tednov po zdravljenju.
English: Tubes should be discarded after first opening.
Slovenian: Odprte tube po prvem odprtju zavrzite.
English: If you forget to use Picato
Slovenian: Če ste pozabili uporabiti zdravilo Picato
English: If you use more Picato than you should
Slovenian: Če ste uporabili večji odmerek zdravila Picato, kot bi smeli
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: In vivo and in vitro models have shown a dual mechanism of action for the effects of ingenol mebutate: 1) induction of local lesion cell death and 2) promoting an inflammatory response characterised by local production of proinflammatory cytokines and chemokines and infiltration of immunocompetent cells.
Slovenian: Modeli in vivo ter in vitro so pokazali dvojni mehanizem delovanja za učinke ingenolmebutata: 1) povzročitev smrti celic v lokalni leziji in 2) pospeševanje vnetnega odziva, za katerega sta značilna lokalna tvorba vnetnih citokinov in kemokinov ter infiltracija imunokompetentnih celic.
English: b Cochran-Mantel-Haenszel test of Picato® gel 150 mcg/g compared to vehicle adjusted for anatomical location (face/scalp) and country.
Slovenian: b Cochran-Mantel-Haenszelov test z gelom Picato 150 µg/g v primerjavi z vehiklom, prilagojen glede na anatomski predel (obraz ali lasišče) in državo.
English: Three prospective, observational long term 1 year follow-up studies were conducted to evaluate sustained efficacy by recurrence of actinic keratosis lesions in the treatment field, and safety in patients who had received treatment with Picato.
Slovenian: Izvedene so bile tri prospektivne dolgotrajne opazovalne študije z 1-letnim sledenjem za ocenitev trajne učinkovitost na podlagi ponovnega nastanka lezij aktinične keratoze na zdravljenem mestu ter varnosti bolnikov, zdravljenih z zdravilom Picato.
English: Lesions clinically atypical for actinic keratosis or suspicious for malignancy should be biopsied to determine appropriate treatment.
Slovenian: Pri lezijah, ki so klinično atipične za aktinično keratozo ali so sumljive za malignost, je treba opraviti biopsijo, za določitev primernega zdravljenja.
English: Necrosis in the dermis was rarely observed.
Slovenian: Nekroza usnjice je bila redko opažena.
English: The first treatment course, given open label, resulted in a complete clearance rate of 62% (277/450).
Slovenian: V prvem krogu zdravljenja, ki je bil odprt, so dosegli 62odstotno stopnjo popolne ozdravitve (277/450).
English: Localised skin responses are transient and typically occur within 1 day of treatment initiation and peak in intensity up to 1 week following completion of treatment.
Slovenian: Lokalizirani odzivi kože so prehodni in se običajno pojavijo v 1 dnevu od začetka zdravljenja, največjo intenzivnost pa dosežejo en teden po zaključku zdravljenja.
English: Overdosing of Picato could result in an increased incidence of local skin responses.
Slovenian: Preveliko odmerjanje zdravila Picato lahko povzroči povečano incidenco lokalnih odzivov kože.
English: The gel from the tube should be squeezed onto a fingertip and spread evenly over the entire treatment area, allowing it to dry for 15 minutes.
Slovenian: Gel iz tube iztisnite na konico prsta, ga enakomerno porazdelite po celotni površini prizadetega mesta in počakajte 15 minut, da se posuši.
English: This medicine is used for topical (on the skin) treatment of actinic keratosis, also called solar keratosis, in adults.
Slovenian: To zdravilo se uporablja za topično zdravljenje (na koži) aktinične keratoze, ki se imenuje tudi solarna keratoza, pri odraslih bolnikih.
English: Partial Clearance( ≥ 75%)
Slovenian: Delna ozdravitev (≥ 75 %)
English: Health care professionals should advise patients to be vigilant for any lesions developing within the treatment area and to seek medical advice immediately should any occur.
Slovenian: Zdravstveni delavci morajo bolnikom svetovati, naj bodo pozorni na morebitne nove lezije, ki se pojavijo na zdravljenem mestu, in naj v primeru nastanka le-teh takoj poiščejo zdravniško pomoč.
English: In vitro study results demonstrate that ingenol mebutate does not inhibit or induce human cytochrome P450 isoforms.
Slovenian: Rezultati študije in vitro so pokazali, da ingenolmebutat ne zavira in ne inducira izoform humanega citokroma P450.
English: As a precautionary measure, it is preferable to avoid the use of Picato during pregnancy.
Slovenian: Iz previdnostnih razlogov se je uporabi zdravila Picato med nosečnostjo bolje izogibati.
English: - Squeeze the gel from one tube onto a fingertip.
Slovenian: - Gel iz ene tube iztisnite na konico prsta.
English: - Do not apply this medicine internally, to the area near the eyes, to the inside of the nostrils, the inside of the ear or on the lips.
Slovenian: - Tega zdravila ne našajte na notranje dele, v bližino oči, na notranjo stran nosnic, notranjost ušes ali na ustnice.
English: Hypersensitivity (including angioedema)
Slovenian: Bolezni imunskega sistema preobčutljivost (vključno z angioedemom)
English: On the basis of the scientific conclusions for ingenol mebutate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ingenol mebutate is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za ingenolmebutat odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) ingenolmebutat, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: After this period, the treatment area may be washed using mild soap and water.
Slovenian: Po preteku tega časa lahko zdravljeno mesto umijete z blagim milom in vodo.
English: To be printed on the inside of the carton lid:
Slovenian: Natisnjeno na notranji strani pokrovčka škatle:
English: Of the 1,165 patients treated with Picato in the actinic keratosis clinical studies conducted with ingenol mebutate gel, 656 patients (56%) were 65 years and older, while 241 patients (21%) were 75 years and older.
Slovenian: Od 1.165 bolnikov, zdravljenih z zdravilom Picato v kliničnih študijah aktinične keratoze z gelom z ingenolmebutatom, je bilo 656 bolnikov (56 %) starih 65 let ali več, 241 bolnikov (21 %) pa je bilo starih 75 let ali več.
English: - The full effect of Picato can be evaluated approximately 8 weeks after treatment.
Slovenian: - Polni učinek zdravila Picato je mogoče oceniti po približno 8 tednih zdravljenja.
English: Picato has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Picato nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Following the application of ingenol mebutate, most patients (>95%) experienced one or more local skin response(s).
Slovenian: Po nanosu gela z ingenolmebutatom se je pri večini bolnikov (> 95 %) pojavil en ali več lokalnih kožnih odzivov.
English: They will usually get better within 2 weeks from when you started the treatment.
Slovenian: Običajno se izboljšajo v 2 tednih po začetku zdravljenja.
English: Ingenol mebutate gel did not demonstrate any potential for photo irritation or photo allergic effects.
Slovenian: Gel z ingenolmebutatom ni pokazal nobenega potenciala za draženje zaradi svetlobe ali za fotoalergijske učinke.
English: They will usually get better within 4 weeks from when you started the treatment.
Slovenian: Običajno se izboljšajo v 4 tednih po začetku zdravljenja.
English: - Do not apply this medicine immediately after taking a shower or less than 2 hours before bedtime.
Slovenian: - Tega zdravila ne nanašajte takoj po prhanju ali manj kot 2 uri pred spanjem.
English: Eleven weeks after baseline which is 8 weeks after Picato gel or vehicle, the complete clearance rate was 61% among patients randomised to Picato gel, and 49% among patients randomised to vehicle.
Slovenian: Enajst tednov po izhodišču, kar ustreza 8 tednom po uporabi gela Picato ali vehikla, je bila stopnja popolne ozdravitve 61 % pri bolnikih, randomiziranih na gel Picato, in 49 % pri bolnikih, randomiziranih na vehikel.
English: Contact with the eyes can cause chemical conjunctivitis and corneal burns.
Slovenian: Izpostavljenost oči Pri stiku z očmi lahko pride do kemično povzročenega vnetja očesne veznice in opeklin roženice.
English: Experience with treatment of a larger area
Slovenian: Izkušnje z zdravljenjem večjih predelov
English: Non-invasive examination of the treated skin by reflectance confocal microscopy have shown that the skin changes induced by ingenol mebutate were reversible, with almost complete normalisation of all measured parameters on day 57 after treatment, which is supported also by clinical findings and studies in animals.
Slovenian: Neinvazivni pregled zdravljene kože z odbojno konfokalno mikroskopijo je pokazal, da so bile kožne spremembe, ki jih je povzročil ingenolmebutat, reverzibilne, saj je 57. dan po zdravljenju prišlo do skoraj popolne normalizacije vseh izmerjenih parametrov, kar potrjujejo tudi klinične ugotovitve in študije na živalih.
English: Contents of the pack and other information What Picato contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Picato
English: Severe local skin responses occurred with an incidence of 29% on the face and scalp and with an incidence of 17% on the trunk and extremities.
Slovenian: Incidenca hudih lokalnih odzivov na koži obraza in lasišča je bila 29-odstotna, na koži trupa in okončin pa 17-odstotna.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Slovenian: Pogostnost neželenih učinkov je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000
English: If accidental exposure occurs, the eyes should be flushed immediately with large amounts of water, and the patient should seek medical care as soon as possible.
Slovenian: Če pride do nenamerne izpostavitve, je treba oči nemudoma izprati z velikimi količinami vode in bolnik naj čim prej poišče zdravniško pomoč.
English: Swelling of the application site is very common (has been reported in more than 1 in 10 people).
Slovenian: Oteklina na mestu nanosa je zelo pogosta (o njej so poročali pri več kot 1 od 10 bolnikov).
English: Animal studies showed slight embryo-fetal toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale blago toksičnost za zarodek/plod (glejte poglavje 5.3).
English: b The lesion-based recurrence rate for each patient defined as the ratio of the number of actinic keratosis lesions at 12 months to the number of lesions at baseline in the previous phase 3 studies.
Slovenian: b Stopnja ponovitve na podlagi lezij je pri vsakem bolniku opredeljena kot razmerje med številom lezij aktinične keratoze v 12. mesecu in številom lezij ob izhodišču prejšnjih študij 3. faze.
English: This medicine does not have any effect on your ability to drive or to use machines.
Slovenian: Zdravilo nima vpliva na sposobnost vožnje ali upravljanje s stroji.
English: Picato should not be used near the eyes, on the inside of the nostrils, on the inside of the ears or on the lips.
Slovenian: Gela Picato se ne sme uporabljati v bližini oči, na notranjem predelu nosnic, na notranjem predelu ušes ali na ustnicah.
English: The mechanism of action of ingenol mebutate for use in actinic keratosis remains to be fully characterised.
Slovenian: Mehanizem delovanja Mehanizem delovanja ingenolmebutata pri aktinični keratozi še ni popolnoma pojasnjen.
English: The mean number of AKs in the Picato group was 5.7 at baseline, 0.8 at week 11, and 0.9 at month 12 as opposed to 5.8, 1.0 and 1.2 in the vehicle group at these time points.
Slovenian: Povprečno število aktiničnih keratoz v skupini z zdravilom Picato je bilo 5,7 ob izhodišču, 0,8 v 11. tednu in 0,9 v 12. mesecu v primerjavi s 5,8, 1,0 in 1,2 v skupini z vehiklom na istih časovnih točkah.
English: A total of 198 patients with complete clearance at day 57 (184 treated with Picato and 14 treated with vehicle) were followed for additionally 12 months.
Slovenian: Spremljali so celokupno 198 bolnikov s popolno ozdravitvijo lezij na 57. dan (184 se jih je zdravilo z zdravilom Picato in 14 z vehiklom) še 12 mesecev.
English: Sun exposure
Slovenian: Izpostavljenost soncu
English: Studies have been conducted to assess the effects of UV irradiation of the skin following single and multiple applications of ingenol mebutate gel, 100 mcg/g.
Slovenian: Izvedene so bile študije, ki so ocenile vpliv UV-sevanja na kožo po enkratni ali večkratni uporabi gela z ingenolmebutatom, 100 µg/g.
English: The percent reduction of the AK count in the Picato group was 83% at 11 weeks and 57% at 12 months, where in the vehicle group it was 78% at 11 weeks and 42% at 12 months.
Slovenian: V skupini z zdravilom Picato se je število aktiničnih keratoz v 11. tednu zmanjšalo na 83 % in v 12. mesecu na 57 % ter v skupini z vehiklom v 11. tednu na 78 % in v 12. mesecu na 42 %.
English: Single-dose laminate tubes with inner layer of High Density Polyethylene (HDPE) and aluminium as the barrier layer.
Slovenian: Večplastne enoodmerne tube z notranjo plastjo iz polietilena velike gostote (HDPE) in aluminijasto pregradno membrano.
English: The table below presents adverse reactions by MedDRA system organ class and anatomical location.
Slovenian: V spodnji preglednici so predstavljeni neželeni učinki v skladu z MedDRA, razvrščeni po organskih sistemih in anatomski umestitvi.
English: Taking into account the treatment purpose for actinic keratosis, which is prevention of skin malignancy, and considering the number of skin tumour cases reported to ingenol mebutate in clinical trials and post-marketing, the PRAC has serious concerns about the impact of the risk of skin tumours on the benefit risk balance of Picato.
Slovenian: Glede na namen zdravljenja aktinične keratoze, tj. preprečevanje malignega obolenja kože, in z upoštevanjem števila primerov tumorjev na koži, o katerih so poročali pri ingenolmebutatu v kliničnih preskušanjih in v obdobju trženja, ima odbor PRAC resne pomisleke glede vpliva tveganja za tumorje na koži na razmerje med koristjo in tveganjem zdravila Picato.
English: In all patients, assessment of efficacy was 8 weeks after the randomisation.
Slovenian: Pri vseh bolnikih so ocenili učinkovitost zdravljenja 8 tednov po randomizaciji.
English: Instructions for use: - Open a new tube each time you use this medicine.
Slovenian: - Vsakič, ko uporabite zdravilo, odprite novo tubo.
English: Face and scalp
Slovenian: Obraz in lasišče
English: Minor fetal abnormalities or variants were observed in the fetuses of treated dams at doses of 1 mcg/kg/day (12 mcg/m2/day).
Slovenian: Manjše nenormalnosti ali odstopanja so opazili pri plodih kunk, ki so dobivale odmerke 1 µg/kg/dan (12 µg/m2/dan).
English: Ingenol mebutate should be used with caution in patients with a history of cutaneous malignancy.
Slovenian: Ingenolmebutat je treba uporabljati previdno pri bolnikih z anamnezo malignega obolenja kože.
English: Table 6 Complete clearancea of the field 8 weeks after randomisation and Month 12 Field recalcitrantc
Slovenian: Preglednica 6 Popolna ozdraviteva zdravljenega predela 8 tednov po randomizaciji in v 12. mesecu
English: Clinical data on treatment in immunocompromised patients is not available, but systemic risks are not expected since ingenol mebutate is not absorbed systemically.
Slovenian: Klinični podatki o zdravljenju pri imunokomprimiranih bolnikih niso na voljo, vendar ni pričakovati sistemskih tveganj, saj se ingenolmebutat ne absorbira sistemsko.
English: The systemic pharmacokinetic profile of ingenol mebutate and its metabolites has not been characterised in humans due to the absence of quantifiable whole blood levels following cutaneous administration.
Slovenian: Sistemskega farmakokinetičnega profila ingenolmebutata in njegovih presnovkov pri ljudeh niso opredelili zaradi odsotnosti merljivih ravni v polni krvi po kožnem nanosu.
English: At end of study (day 57), the rate of squamous cell carcinoma (SCC) reported in the treatment area was comparable in patients treated with ingenol mebutate gel (0.3%, 3 of 1,165 patients) and in vehicle treated patients (0.3%, 2 of 632 patients) in the actinic keratosis clinical studies conducted with ingenol mebutate gel.
Slovenian: Ob koncu študije (57. dan) je bila stopnja skvamoznega karcinoma, o kateri so poročali na mestu zdravljenja, primerljiva s stopnjo pri bolnikih, zdravljenih z gelom z ingenolmebutatom (0,3 %, 3 od 1.165 bolnikov), in pri bolnikih, zdravljenih z vehiklom (0,3 %, 2 od 632 bolnikov) v kliničnih študijah za zdravljenje aktinične keratoze z gelom z ingenolmebutatom.
English: What Picato looks like and contents of the pack
Slovenian: Izgled zdravila Picato in vsebina pakiranja
English: Study patients ranged from 34 to 89 years of age (mean 64 and 66 years, respectively, for the two strengths) and 94% had Fitzpatrick skin type I, II, or III.
Slovenian: Vključeni bolniki so bili stari od 34 do 89 let (povprečna starost pri eni jakosti je bila 64, pri drugi pa 66 let), 94 % bolnikov pa je imelo tip kože I, II ali III po Fitzpatrickovi lestvici.
English: Gene expression profiles of skin biopsies from the treated areas is suggestive of inflammatory responses and response to wounding, which is consistent with the histology assessments.
Slovenian: Profili izražanja genov pri biopsiji kože na zdravljenih mestih kažejo na vnetne odzive in odzive na poškodovanje, ki se ujemajo s histološkimi ocenami.
English: - The other ingredients are isopropyl alcohol, hydroxyethylcellulose, citric acid monohydrate, sodium citrate, benzyl alcohol, purified water.
Slovenian: - Druge sestavine zdravila so izopropilni alkohol, hidroksietilceluloza, citronska kislina monohidrat, natrijev citrat, benzilni alkohol, prečiščena voda.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Picato in all subsets of the paediatric population in actinic keratosis (see section 4.2 for information on paediatric use).
Slovenian: Picato za vse podskupine pediatrične populacije z aktinično keratozo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Mean (SD) a The recurrence rate is the Kaplan-Meier (KM) estimate at the target study date of the visit expressed as a percentage (95% CI).
Slovenian: a Stopnja ponovitve je ocena po Kaplan-Meier (KM), opravljena ob ciljnem datumu obiska za namene študije in izražena v odstotkih (95-odstotni interval zaupanja).
English: How to use Picato
Slovenian: Kako uporabljati zdravilo Picato
English: Do not use this medicine after the expiry date which is stated on the carton and tube after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in tubi poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Picato is indicated for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.
Slovenian: Zdravilo Picato je indicirano za zdravljenje kože pri nehiperkeratotični, nehipertrofični aktinični keratozi pri odraslih bolnikih.
English: Management of actinic keratosis
Slovenian: Obravnava aktinične keratoze
English: The nursing mother should be instructed that physical contact between her newborn/infant and the treated area should be avoided for a period of 6 hours after application of Picato.
Slovenian: Doječim materam je treba dati navodilo, da novorojenček/dojenček še 6 ur po nanosu zdravila Picato ne sme priti v telesni stik z zdravljenim mestom.
English: 12/163 subjects treated with an investigational product of ingenol mebutate reported 16 skin tumour events inside the treatment area (1 SCC, 1 Bowen's disease and 14 keratoacanthoma following centralised pathology review) compared to 0/61 in the vehicle group.
Slovenian: 12 od 163 oseb, zdravljenih s preiskovanim zdravilom ingenolmebutatom, je poročalo o 16 primerih tumorjev na koži, ki so se pojavili na zdravljenem mestu (1 skvamozni karcinom, 1 morbus Bowen in 14 keratoakantomov po centraliziranem patološkem pregledu), v primerjavi z 0 od 61 oseb v skupini, zdravljeni z vehiklom.
English: Isopropyl alcohol Hydroxyethylcellulose Citric acid monohydrate Sodium citrate Benzyl alcohol Purified water
Slovenian: izopropilni alkohol hidroksietilceluloza citronska kislina monohidrat natrijev citrat benzilni alkohol prečiščena voda