FrancophonIA/ELRC3.0 huggingface dataset:
English: The randomised phase III INTEREST study was conducted in patients with locally advanced or metastatic NSCLC who had previously received platinum-based chemotherapy.
Slovenian: Randomizirana študija III. faze INTEREST je bila opravljena pri bolnikih z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč, ki so predhodno dobivali kemoterapijo na podlagi platine.
English: Mean absolute bioavailability is 59% in cancer patients.
Slovenian: Povprečna absolutna biološka uporabnost pri onkoloških bolnikih je 59 %.
English: A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day.
Slovenian: Zmanjšanje plodnosti pri podganah je bilo opaženo pri odmerku 20 mg/kg/dan.
English: Liver function test abnormalities (including increases in alanine aminotransferase, aspartate aminotransferase, bilirubin) have been observed, uncommonly presenting as hepatitis (see section 4.8).
Slovenian: Opažene so bile nepravilnosti testov jetrnih funkcij (vključno z zvišanjem alanin-aminotransferaze, aspartat-aminotransferaze, bilirubina), občasno zabeležene kot hepatitis (glejte poglavje 4.8).
English: In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 IRESSA-treated patients), the most frequently reported adverse drug reactions (ADRs), occurring in more than 20% of the patients, are diarrhoea and skin reactions (including rash, acne, dry skin and pruritus).
Slovenian: V kumulativnem naboru podatkov kliničnih preskušanj III. faze ISEL, INTEREST in IPASS (2462 bolnikov, zdravljenih z zdravilom IRESSA) so bili najpogosteje opisani neželeni učinki, ki so se pojavili pri več kot 20 % bolnikov, driska in kožne reakcije (vključno z izpuščajem, aknami, suho kožo in srbenjem).
English: Elevations in alanine aminotransferase, mainly mild to moderate
Slovenian: Zvišanje alanin aminotransferaze, v glavnem blago do zmerno
English: Film-coated tablets (tablet).
Slovenian: filmsko obložene tablete (tablete)
English: When considering the use of IRESSA as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients.
Slovenian: Ko presojate o uporabi zdravila IRESSA za zdravljenje lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka, je pomembno da, pri vseh bolnikih poskusite določiti mutacijo EGFR tumorskega tkiva.
English: Gefitinib has been evaluated in a clinical trial conducted in 41 patients with solid tumours and normal hepatic function, or moderate or severe hepatic impairment (classified according to baseline Common Toxicity Criteria grades for AST, alkaline phosphatase and bilirubin) due to liver metastases.
Slovenian: Gefitinib so ocenili v kliničnem preskušanju 41 bolnikov s čvrstimi tumorji in normalnim delovanjem jeter ali zmerno do hudo okvaro jeter (razvrščeno po izhodiščnih stopnjah Skupnih meril toksičnosti [Common Toxicity Criteria] za AST, alkalno fosfatazo in bilirubin) zaradi metastaz na jetrih.
English: Such an increase might potentially be relevant for CYP2D6 substrates with narrow therapeutic index.
Slovenian: Takšno povečanje bi lahko bilo pomembno pri substratih CYP2D6, ki imajo ozek terapevtski indeks.
English: Gefitinib has a mean steady-state volume of distribution of 1400 l indicating extensive distribution into tissue.
Slovenian: Povprečni volumen porazdelitve gefitiniba v stanju dinamičnega ravnovesja je 1400 litrov, kar kaže na izdatno porazdelitev v tkiva.
English: Interstitial lung disease (1.3%), often severe (CTC grade 3-4).
Slovenian: Intersticijska bolezen pljuč (1,3 %), pogosto huda (3.- 4. stopnja po CTC).
English: Skin reactions, mainly a mild or moderate (CTC grade 1 or 2) pustular rash, sometimes itchy with dry skin, including skin fissures, on an erythematous base
Slovenian: Kožne reakcije, v glavnem blage ali zmerne (1. ali 2. stopnja po CTC), pustulozen izpuščaj, včasih srbeč s suho kožo, vključno s fisurami na koži, na eritematozni podlagi
English: NR vs 4.3 m
Slovenian: s 4,3 m
English: The frequency of adverse drug reactions relating to abnormal laboratory values is based on patients with a change from baseline of 2 or more CTC grades in the relevant laboratory parameters.
Slovenian: Pogostnost neželenih učinkov v zvezi z nenormalnimi laboratorijskimi vrednostmi temelji na bolnikih, ki so se jim ustrezni laboratorijski parametri v primerjavi z izhodiščem spremenili za 2 ali več po CTC.
English: Overall
Slovenian: Celotna
English: Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes).
Slovenian: Med simptomi so lahko splošno slabo počutje z zlatenico (porumenelostjo kože in oči) ali brez nje.
English: If ILD is confirmed, IRESSA should be discontinued and the patient treated appropriately.
Slovenian: Če je potrjena IBP, morate terapijo z zdravilom IRESSA končati in bolnika ustrezno zdraviti.
English: Asians
Slovenian: Azijci
English: The common EGFR activating mutations (Exon 19 deletions; L858R) have robust response data supporting sensitivity to gefitinib; for example a progression free survival HR (95% CI) of 0.489 (0.336, 0.710) for gefitinib vs. doublet chemotherapy [WJTOG3405].
Slovenian: Za pogoste aktivacijske mutacije EGFR (delecije v eksonu 19, L858R) obstajajo trdni podatki o odzivu, ki potrjujejo občutljivost za gefitinib, na primer razmerje ogroženosti (s 95 % IZ) za preživetje brez napredovanja bolezni je 0,489 (0,336, 0,710) za gefitinib v primerjavi s kemoterapijskim dvojčkom [WJTOG3405].
English: In poor metabolisers no measurable levels of O-desmethyl gefitinib were produced.
Slovenian: Pri slabih metabolizatorjih niso ugotovili merljive koncentracije O-dezmetilgefitiniba.
English: N Objective response rates and 95% CI for difference between treatments
Slovenian: Populacija N Objektivni delež odziva in 95 % IZ za razlike med zdravljenji
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib.
Slovenian: Bolniki z zmerno do hudo okvaro jeter (stopnja B ali C po Child-Pughu) imajo zaradi ciroze večjo koncentracijo gefitiniba v plazmi.
English: Gefitinib and metabolites of gefitinib accumulated in milk of lactating rats (see section 5.3).
Slovenian: Gefitinib in njegovi presnovki se kopičijo v mleku doječih podgan (glejte poglavje 5.3).
English: CYP2D6 poor metabolisers
Slovenian: Slabi metabolizatorji s CYP2D6
English: HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
Slovenian: c Interval zaupanja je v celoti pod mejo neinferiornosti 1,154.
English: At steady state, circulating plasma concentrations are typically maintained within a 2- to 3-fold range over the 24-hour dosing interval.
Slovenian: V stanju dinamičnega ravnovesja se koncentracija v krožeči plazmi v 24-urnem odmernem intervalu praviloma ohrani znotraj 2- do 3-kratnega območja.
English: Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy (see section 4.3).
Slovenian: Gefitinib je med obdobjem dojenja kontraindiciran, zato je treba med zdravljenjem z gefitinibom dojenje prekiniti (glejte poglavje 4.3).
English: In a trial in healthy volunteers where gastric pH was maintained above pH 5, gefitinib exposure was reduced by 47%, likely due to impaired solubility of gefitinib in the stomach (see sections 4.4 and 4.5).
Slovenian: Zdravim prostovoljcem, ki so jim v preskušanju vzdrževali pH v želodcu nad pH 5, se je izpostavljenost gefitinibu zmanjšala za 47 %, verjetno zaradi slabše topnosti gefitiniba v želodcu (glejte poglavji 4.4 in 4.5).
English: In a phase I open-label study of single dose gefitinib 250 mg in patients with mild, moderate or severe hepatic impairment due to cirrhosis (according to Child-Pugh classification), there was an increase in exposure in all groups compared with healthy controls.
Slovenian: V odprti študiji I. faze s posamičnim odmerkom 250 mg gefitiniba pri bolnikih z blago, zmerno ali hudo okvaro jeter zaradi ciroze (razvrstitev po Child-Pughu) so v vseh skupinah ugotovili večjo izpostavljenost v primerjavi z zdravimi primerjalnimi osebami.
English: If patients experience worsening of respiratory symptoms such as dyspnoea, cough and fever, IRESSA should be interrupted and the patient should be promptly investigated.
Slovenian: Če se bolniku poslabšajo dihalni simptomi, npr. dispneja, kašelj in zvišana telesna temperatura, morate zdravljenje z zdravilom IRESSA prekiniti in bolnika takoj preiskati.
English: Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever.
Slovenian: • Resno težko dihanje ali nenadno poslabšanje težkega dihanja, lahko s spremljajočim kašljem ali zvišano telesno temperaturo.
English: IRESSA is a round brown tablet marked with ‘IRESSA 250' on one side and plain on the other.
Slovenian: Zdravilo IRESSA so okrogle rjave tablete z oznako ‘IRESSA 250‘ na eni strani in brez oznake na drugi.
English: Pancreatitis Gastrointestinal perforation
Slovenian: Pankreatitis Gastrointestinalna perforacija
English: In vitro data indicate that gefitinib is a substrate for the membrane transport protein P-gp.
Slovenian: Podatki in vitro kažejo, da je gefitinib substrat membranske transportne beljakovine Pgp.
English: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium Povidone (K29-32) (E1201) Sodium laurilsulfate Magnesium stearate
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza (E460) premreženi natrijev karmelozat povidon (K29-32) (E1201) natrijev lavrilsulfat magnezijev stearat
English: It was shown that following daily administration of 250 mg gefitinib, time to steady-state, total plasma clearance (CmaxSS) and steady-state exposure (AUC24SS) were similar for the groups with normal and moderately impaired hepatic function.
Slovenian: Ugotovili so, da so bili po uporabi 250 mg gefitiniba na dan čas do stanja dinamičnega ravnovesja, celotni plazemski očistek (CmaxSS) in izpostavljenost v stanju dinamičnega ravnovesja (AUC24SS) podobni v skupinah z normalnim in zmerno okvarjenim delovanjem jeter.
English: Hepatotoxicity and liver impairment
Slovenian: Hepatotoksičnost in okvara jeter
English: One ILD-type event was fatal, and this occurred in a patient receiving placebo.
Slovenian: En dogodek tipa IBP je bil smrten; pojavil se je pri bolniku, ki je dobival placebo.
English: There are no data on concomitant treatment with an inhibitor of CYP2D6 but potent inhibitors of this enzyme might cause increased plasma concentrations of gefitinib in CYP2D6 extensive metabolisers by about 2-fold (see section 5.2).
Slovenian: Podatkov o sočasnem zdravljenju z zaviralci CYP2D6 ni, toda močni zaviralci tega encima lahko pri izrazitih metabolizatorjih s CYP2D6 povečajo koncentracijo gefitiniba v plazmi za približno 2-krat (glejte poglavje 5.2).
English: Primary endpoint overall survival abc
Slovenian: Primarni opazovani dogodek Skupno preživetje abc
English: Each tablet contains 3.86 mg of sodium.
Slovenian: Ena tableta vsebuje 3,86 mg natrija.
English: Gefitinib is excreted mainly as metabolites via the faeces, with renal elimination of gefitinib and metabolites accounting for less than 4% of the administered dose.
Slovenian: Gefitinib se izloči predvsem v obliki presnovkov v blatu; na račun odstranjevanja gefitiniba in presnovkov skozi ledvice gre manj kot 4 % uporabljenega odmerka.
English: In vitro data indicate that CYP3A4 and CYP2D6 are the major P450 isozyme involved in the oxidative metabolism of gefitinib.
Slovenian: Podatki in vitro kažejo, da sta CYP3A4 in CYP2D6 glavna izoencima P450, vključena v oksidativno presnovo gefitiniba.
English: When the use of CYP2D6 substrates are considered in combination with gefitinib, a dose modification of the CYP2D6 substrate should be considered especially for products with a narrow therapeutic window.
Slovenian: Če razmišljate o sočasni uporabi substratov CYP2D6 v kombinaciji z gefitinibom, morate razmisliti tudi o prilagoditvi odmerka substrata CYP2D6, zlasti pri zdravilih, ki imajo ozko terapevtsko okno.
English: In a post-marketing surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving gefitinib was 5.8%.
Slovenian: V japonski pomarketinški spremljevalni študiji 3350 bolnikov je bil delež učinkov tipa IBP med prejemniki gefitiniba 5,8 %.
English: Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Slovenian: Obloga tablete hipromeloza (E464) makrogol 300 titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
English: Therefore, concomitant administration of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum) may reduce efficacy of the treatment and should be avoided (see section 4.5).
Slovenian: Zato lahko sočasna uporaba induktorjev CYP3A4 (npr. fenitoina, karbamazepina, rifampicina, barbituratov ali zeliščnih pripravkov, ki vsebujejo šentjanževko/Hypericum perforatum) zmanjša učinkovitost zdravljenja in se ji je treba izogniti (glejte poglavje 4.5).
English: EGFR mutation status and clinical characteristics Clinical characteristics of never smoker, adenocarcinoma histology, and female gender have been shown to be independent predictors of positive EGFR mutation status in a multivariate analysis of 786 Caucasian patients from gefitinib studies* (see Table 7).
Slovenian: Klinične značilnosti, da oseba ni nikdar kadila, da ima histologijo adenokarcinoma in da je ženskega spola, so bile neodvisni napovedniki pozitivnega stanja mutacije EGFR v multivariatni analizi 786 bolnikov-belcev v študijah gefitiniba* (glejte preglednico 7).
English: Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
Slovenian: • zaviralce protonske črpalke, antagoniste H2 ali antacide (za razjede, težave z želodcem, zgago in zmanjšanje kisline v želodcu).
English: The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, povidone (K29-32) (E1201), sodium laurilsulfate, magnesium stearate, hypromellose (E464), macrogol 300, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
Slovenian: • Druge sestavine zdravila (pomožne snovi) so laktoza monohidrat, mikrokristalna celuloza (E460), premreženi natrijev karmelozat, povidon (K29-32) (E1201), natrijev lavrilsulfat, magnezijev stearat, hipromeloza (E464), makrogol 300, titanov dioksid (E171), rumeni železov oksid (E172) in rdeči železov oksid (E172).
English: **This includes isolated reports of hepatic failure which in some cases led to fatal outcomes.
Slovenian: ** To vključuje posamezne primere odpovedi jeter, od katerih so se nekateri končali s smrtjo.
English: Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
Slovenian: • Izsušenost (pogosta) zaradi dolgotrajne ali hude driske, bruhanje, siljenje na bruhanje (slabost v želodcu) ali izguba apetita.
English: IRESSA comes in blister packs of 30 tablets.
Slovenian: Zdravilo IRESSA je na voljo v škatli po 30 tablet.
English: Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes.
Slovenian: • Težave z očmi (občasne), npr. bolečine, pordelost, solzenje, občutljivost na svetlobo, spremembe vida ali vraščanje trepalnic.
English: The recommended posology of IRESSA is one 250 mg tablet once a day.
Slovenian: Priporočeno odmerjanje zdravila IRESSA je ena 250-mg tableta enkrat na dan.
English: When administered to the rat throughout gestation and parturition, there was a reduction in pup survival at a dose of 20 mg/kg/day.
Slovenian: Če je bil uporabljen pri podganah med celotno gestacijo in kotenjem, se je pri odmerku 20 mg/kg/dan skrajšalo preživetje mladičev.
English: IRESSA contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free.'
Slovenian: Natrij zdravilo IRESSA vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
English: In a clinical trial in patients, gefitinib was co-administered with metoprolol (a CYP2D6 substrate).
Slovenian: V enem kliničnem preskušanju pri bolnikih so gefitinib uporabljali hkrati z metoprololom (ki je substrat CYP2D6).
English: 30 film-coated tablets.
Slovenian: 30 filmsko obloženih tablet
English: Active substances that may increase gefitinib plasma concentrations In vitro studies have shown that gefitinib is a substrate of p-glycoprotein (Pgp).
Slovenian: Zdravilne učinkovine, ki lahko povečajo koncentracijo gefitiniba v plazmi Študije in vitro so pokazale, da je gefitinib substrat p-glikoproteina (Pgp).
English: Pretreated patients
Slovenian: Predhodno zdravljeni bolniki
English: Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers.
Slovenian: Predhodno zdravljenje z itrakonazolom (močnim zaviralcem CYP3A4) je pri zdravih prostovoljcih povečalo povprečno AUC gefitiniba za 80 %.
English: There were no compound-induced malformations in either species.
Slovenian: Pri drugih živalskih vrstah spojina ni izzvala malformacij.
English: Gastrointestinal perforation
Slovenian: • gastrointestinalna perforacija
English: Only limited data are available in patients with creatinine clearance  20 ml/min and caution is advised in these patients (see section 5.2).
Slovenian: Za bolnike z očistkom kreatinina  20 ml/min je le malo podatkov, zato je pri njih potrebna previdnost (glejte poglavje 5.2).
English: Pack size of 30 film-coated tablets.
Slovenian: Velikost pakiranja: 30 filmsko obloženih tablet.
English: The recommended dose is one 250mg tablet per day.
Slovenian: • Priporočeni odmerek je ena 250 mg tableta na dan.
English: Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ≥ 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).
Slovenian: Sočasna uporaba gefitiniba z ranitidinom v odmerku, ki je dolgotrajno zvišal pH v želodcu ≥ 5, je pri zdravih prostovoljcih zmanjšala povprečno AUC gefitiniba za 47 % (glejte poglavji 4.4 in 5.2).
English: Do not take IRESSA if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section6, ‘What IRESSAcontains').
Slovenian: • če ste alergični na gefitinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: In individual patients with CYP2D6 poor metaboliser genotype, treatment with a potent CYP3A4 inhibitor might lead to increased plasma levels of gefitinib.
Slovenian: Pri posameznih bolnikih, ki imajo genotip slabih metabolizatorjev s CYP2D6, lahko zdravljenje z močnim zaviralcem CYP3A4 poveča koncentracijo gefitiniba v plazmi.
English: Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1)
Slovenian: Konjunktivitis, blefaritis in suho oko*, v glavnem blagi (1. stopnja po CTC)
English: Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort/ Hypericum perforatum) should be avoided.
Slovenian: Sočasni uporabi zdravil, ki inducirajo CYP3A4 (npr. fenitoina, karbamazepina, rifampicina, barbituratov ali šentjanževke (Hypericum perforatum)), se je treba izogniti.
English: Do not use this medicine after the expiry date which is stated on the carton, blister and overwrap foil after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu in zunanjem ovoju za oznako EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Substances that inhibit CYP3A4 may decrease the clearance of gefitinib.
Slovenian: Snovi, ki zavirajo CYP3A4, lahko zmanjšajo očistek gefitiniba.
English: Risk of mortality among patients who developed ILD on IRESSA or chemotherapy was higher in patients with the following risk factors: smoking, CT scan evidence of reduced normal lung (≤ 50%), pre-existing ILD, older age (≥ 65 years old), and extensive areas adherent to pleura (≥ 50%).
Slovenian: Med bolniki, ki se jim je med zdravljenjem z zdravilom IRESSA ali kemoterapijo pojavila IBP, je bilo tveganje umrljivosti večje, če so imeli naslednje dejavnike tveganja: kajenje, računalniškotomografske znake zmanjšanja normalnih pljuč (≤ 50 %), že prej obstoječo IBP, višjo starost (≥ 65 let) in obsežne predele adherentne pljučne plevre (≥ 50 %).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Each tablet contains 250 mg gefitinib.
Slovenian: Vsaka tableta vsebuje 250 mg gefitiniba.
English: Pre-treatment with rifampicin (a potent CYP3A4 inducer) in healthy volunteers reduced mean gefitinib AUC by 83% (see section 4.4).
Slovenian: Predhodno zdravljenje z rifampicinom (močnim induktorjem CYP3A4) je pri zdravih prostovoljcih zmanjšalo povprečno AUC gefitiniba za 83 % (glejte poglavje 4.4).
English: If it is less than 12 hours until your next dose: skip the missed tablet.
Slovenian: • Če je do naslednjega odmerka manj kot 12 ur: Izpustite pozabljeno tableto.
English: The randomised phase III ISEL study was conducted in patients with advanced NSCLC who had received 1 or 2 prior chemotherapy regimens and were refractory or intolerant to their most recent regimen.
Slovenian: Randomizirana študija III. faze ISEL je bila opravljena pri bolnikih z napredovalim nedrobnoceličnim rakom pljuč, ki so dobili 1 ali 2 predhodni kemoterapiji in so bili odporni proti zadnji uporabljeni shemi ali je niso prenesli.
English: IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section
Slovenian: Zdravilo IRESSA je indicirano kot monoterapija za zdravljenje odraslih bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom z aktivacijskimi mutacijami EGFR-TK (glejte poglavje 4.4).
English: The increase may be clinically relevant since adverse reactions are related to dose and exposure.
Slovenian: Povečanje bi lahko bilo klinično pomembno, ker so neželeni učinki povezani z odmerkom in izpostavljenostjo.
English: Very common: side effects (may affect more than 1 in 10 people) Diarrhoea
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
English: The majority of ILD-type events reported was from patients of Asian ethnicity and the ILD incidence among patients of Asian ethnicity receiving gefitinib therapy and placebo was approximately 3% and 4% respectively.
Slovenian: Incidenca IBP je bila med bolniki azijske etnične pripadnosti, ki so dobivali gefitinib približno 3 %, in pri tistih, ki so dobivali placebo približno 4 %.
English: Interstitial lung disease (ILD) has occurred in 1.3% of patients, often severe (CTC grade 3-4).
Slovenian: Intersticijska bolezen pljuč (IBP) se je pojavila pri 1,3 % bolnikov in je bila pogosto huda (3.- 4. stopnja po CTC).
English: 28/70 (40%) of never smokers are M+ 47/716 (7%) of ever smokers are M+
Slovenian: 28/70 (40 %) tistih, ki niso nikoli kadili, je M+
English: One ILD-type event was fatal, and this occurred in a patient receiving gefitinib.
Slovenian: En dogodek tipa IBP je bil smrten; pojavil se je pri bolniku, ki je dobival gefitinib.
English: Do not take IRESSA if you are breast-feeding for the safety of your baby.
Slovenian: Zaradi varnosti vašega otroka ne jemljite zdravila IRESSA, če dojite.