FrancophonIA/ELRC3.0 huggingface dataset:
English: In the IPASS trial, IRESSA demonstrated superior PFS, ORR, QoL and symptom relief with no significant difference in overall survival compared to carboplatin/paclitaxel in previously untreated patients, with locally advanced or metastatic NSCLC, whose tumours harboured activating mutations of the EGFR tyrosine kinase.
Slovenian: V preskušanju IPASS je zdravilo IRESSA dokazalo, da je boljše glede preživetja brez napredovanja bolezni (PFS), objektivnega deleža odziva (ORR), kakovosti življenja in olajšanja simptomov, brez pomembnih razlik v skupnem preživetju v primerjavi z zdravljenjem s karboplatinom/paklitakselom pri predhodno nezdravljenih bolnikih z lokalno napredovalim ali metastatskim nedrobnoceličnim rakom pljuč, ki imajo tumorje z aktivacijskimi mutacijami tirozin-kinaze EGFR.
English: Anorexia mild or moderate (CTC grade 1 or 2)
Slovenian: Anoreksija, blaga do zmerna (1. ali 2. stopnje po CTC)
English: Gefitinib should be used cautiously in the presence of mild to moderate changes in liver function.
Slovenian: V primeru blagih do zmernih sprememb v delovanju jeter je treba gefitinib uporabljati previdno.
English: Diarrhoea, mainly mild or moderate (CTC grade 1 or 2) Vomiting, mainly mild or moderate (CTC grade 1 or 2) Nausea, mainly mild (CTC grade 1)
Slovenian: Driska, v glavnem blaga ali zmerna (1. ali 2. stopnja po CTC) Bruhanje, v glavnem blago ali zmerno (1. ali 2. stopnja po CTC) Navzea, v glavnem blaga (1. stopnja po CTC)
English: However, in phase I clinical trials, a limited number of patients were treated with daily doses of up to 1000 mg. An increase of frequency and severity of some adverse reactions was observed, mainly diarrhoea and skin rash.
Slovenian: Specifičnega zdravljenja za preveliko odmerjanje gefitiniba ni. So pa v kliničnih preskušanjih I. faze manjše število bolnikov zdravili z dnevnimi odmerki do 1000 mg. Opažali so večjo pogostnost in izrazitost nekaterih neželenih učinkov, predvsem driske in kožnega izpuščaja.
English: This increase in exposure may be of clinical relevance since adverse experiences are related to dose and exposure to gefitinib.
Slovenian: To povečanje izpostavljenosti bi lahko bilo klinično pomembno, ker so neželeni učinki povezani z odmerkom in izpostavljenostjo gefitinibu.
English: During treatment with gefitinib, asthenia has been reported.
Slovenian: Med zdravljenjem z gefitinibom je bila opisana astenija.
English: When gefitinib was administered to rats during organogenesis, there were no effects on embryofoetal development at the highest dose (30 mg/kg/day).
Slovenian: Če je bil gefitinib pri podganah uporabljen med obdobjem organogeneze, tudi z največjim odmerkom (30 mg/kg/dan) niso ugotovili učinkov na embrio-fetalni razvoj, pri kuncih pa se je pri odmerkih 20 mg/kg/dan in več pojavilo zmanjšanje telesne mase plodov.
English: The increase might be higher in individual patients with CYP2D6 poor metaboliser genotype.
Slovenian: Povečanje je lahko izrazitejše pri bolnikih, ki imajo genotip slabih metabolizatorjev s CYP2D6.
English: Concomitant administration with potent inhibitors of CYP3A4 activity (e.g. ketoconazole, posaconazole, voriconazole, protease inhibitors, clarithromycin, telithromycin) may increase gefitinib plasma concentrations.
Slovenian: Sočasna uporaba močnih zaviralcev CYP3A4 (npr. ketokonazola, posakonazola, vorikonazola, zaviralcev proteaz, klaritromicina, telitromicina) lahko poveča koncentracijo gefitiniba v plazmi.
English: How to take IRESSA
Slovenian: Kako jemati zdravilo IRESSA
English: a Values presented are for IRESSA versus placebo.
Slovenian: a Prikazane so vrednosti za zdravilo IRESSA v primerjavi s placebom.
English: Impaired liver function due to cirrhosis has been shown to lead to increased plasma concentrations of gefitinib (see section 5.2).
Slovenian: Ugotovljeno je, da okvara delovanja jeter zaradi ciroze zviša koncentracijo gefitiniba v plazmi (glejte poglavje 5.2).
English: Fever
Slovenian: • vročina
English: At initiation of treatment with a CYP3A4 inhibitor, patients should be closely monitored for gefitinib adverse reactions (see section 4.5).
Slovenian: Na začetku zdravljenja z zaviralcem CYP3A4 je treba bolnike natančno kontrolirati glede neželenih učinkov gefitiniba (glejte poglavje 4.5).
English: Factors that predicted for presence of EGFR mutation p-value
Slovenian: Dejavniki, ki napovejo prisotnost mutacije EGFR
English: HR Hazard ratio (hazard ratios <1 favour IRESSA)
Slovenian: ROG razmerje ogroženosti (razmerja ogroženosti < 1 so v korist zdravila IRESSA)
English: In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Slovenian: Študije in vitro so pokazale omejen potencial gefitiniba za zaviranje CYP2D6.
English: Herbal remedies containing St John's wort (Hypericum perforatum, used for depression and anxiety).
Slovenian: • zeliščna zdravila, ki vsebujejo šentjanževko (Hypericum perforatum za depresijo in tesnobnost
English: Progression free survival ab
Slovenian: Preživetje brez napredovanja bolezni ab
English: The major metabolite identified was O-desmethyl gefitinib, which is 14-fold less potent than gefitinib at inhibiting EGFR stimulated cell growth and has no inhibitory effect on tumour cell growth in mice.
Slovenian: Ta zavre prek EGRF stimulirano rast celic 14-krat manj močno kot gefitinib in pri miših ne zavira rasti tumorskih celic.
English: If concomitant treatment with a potent CYP2D6 inhibitor is initiated, the patient should be closely monitored for adverse reactions.
Slovenian: V primeru uvedbe sočasnega zdravljenja z močnim zaviralcem CYP2D6 je treba bolnike natančno kontrolirati glede neželenih učinkov.
English: a Values presented are for IRESSA versus docetaxel.
Slovenian: a Prikazane so vrednosti za zdravilo IRESSA v primerjavi z docetakselom.
English: Medicinal products that cause significant sustained elevation in gastric pH, such as proton-pump inhibitors and h2-antagonists may reduce bioavailability and plasma concentrations of gefitinib and, therefore, may reduce efficacy.
Slovenian: Zdravila, ki občutno in dolgotrajno zvišajo pH v želodcu npr. zaviralci protonske črpalke in antagonisti H2, lahko zmanjšajo biološko uporabnost gefitiniba in njegovo koncentracijo v plazmi in tako zmanjšajo učinkovitost.
English: In EGFR mutation-positive patients, significantly more IRESSA-treated patients experienced an improvement in quality of life and lung cancer symptoms vs. carboplatin/paclitaxel (see Table 4).
Slovenian: Med bolniki s pozitivno mutacijo EGFR so se kakovost življenja in simptomi pljučnega raka izboljšali značilno več bolnikom, zdravljenim z zdravilom IRESSA, kot bolnikom, zdravljenim s karboplatinom/paklitakselom (glejte preglednico 4).
English: Data from phase II clinical trials, where gefitinib and vinorelbine have been used concomitantly, indicate that gefitinib may exacerbate the neutropenic effect of vinorelbine.
Slovenian: faze, v katerih so sočasno uporabljali gefitinib in vinorelbin, kažejo, da lahko gefitinib poslabša nevtropenični učinek vinorelbina.
English: Table 4 Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Slovenian: Preglednica 4 Izidi kakovosti življenja z gefitinibom v primerjavi s karboplatinom/paklitakselom v študiji IPASS
English: Bleeding (such as nose bleed or blood in your urine) Protein in your urine (shown in a urine test)
Slovenian: • krvavitev (npr. krvavitev iz nosu ali kri v urinu)
English: Further precautions for use
Slovenian: Dodatni previdnostni ukrepi
English: The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6.
Slovenian: Gefitinib se pretežno presnovi prek izoencima CYP3A4 citokroma P450, pa tudi prek izoencima CYP2D6.
English: Numbers in square brackets are 95% confidence intervals for HR N Number of patients randomised.
Slovenian: Številke v oglatih oklepajih so 95 % intervali zaupanja za ROG.
English: No specific dose adjustment is recommended in patients with known CYP2D6 poor metaboliser genotype, but these patients should be closely monitored for adverse events (see section 5.2).
Slovenian: Bolniki, ki imajo genotip slabih metabolizatorjev s CYP2D6, ne potrebujejo specifične prilagoditve odmerka, vendar jih je treba natančno kontrolirati glede neželenih učinkov (glejte poglavje 5.2).
English: Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Slovenian: Zdravilne učinkovine, katerih koncentracijo v plazmi lahko spremeni gefitinib Študije in vitro so pokazale omejen potencial gefitiniba za zaviranje CYP2D6.
English: This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free'.
Slovenian: Zdravilo IRESSA vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: PODATKI NAVEDENI NA ZUNANJI OVOJNINI
English: 1692 8.0% vs 1.3%
Slovenian: 1692 8,0 % v prim.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ
English: 1 with advanced (stage IIIB or IV) NSCLC of adenocarcinoma histology who were ex-light smokers (ceased smoking > 15 years ago and smoked < 10 pack years) or never smokers (see Table 3).
Slovenian: Randomizirana študija III. faze IPASS v zdravljenju prve izbire je bila opravljena pri bolnikih v Aziji bolniki so imeli napredovalega (stadij IIIB ali IV) nedrobnoceličnega pljučnega raka s histološko sliko adenokarcinoma ter so bili nekdanji blagi kadilci (kajenje so opustili pred > 15 let in so kadili < 10 škatlic-let) ali niso nikoli kadili (glejte preglednico 3).
English: Table 5 Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study
Slovenian: Preglednica 5 Izidi učinkovitosti gefitiniba v primerjavi z docetakselom v študiji INTEREST
English: High doses of short-acting antacids may have a similar effect if taken regularly close in time to administration of gefitinib.
Slovenian: Veliki odmerki kratkodelujočih antacidov, uporabljenih blizu časa jemanja gefitiniba, imajo lahko podoben učinek.
English: If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: 342 12.4% vs 2.1%
Slovenian: 342 12,4 % v prim.
English: Active substances that may reduce gefitinib plasma concentrations Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Slovenian: Zdravilne učinkovine, ki lahko zmanjšajo koncentracijo gefitiniba v plazmi Snovi, ki inducirajo CYP3A4, lahko povečajo presnovo in zmanjšajo koncentracijo gefitiniba v plazmi ter tako zmanjšajo učinkovitost gefitiniba.
English: CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations.
Slovenian: Induktorji CYP3A4 lahko povečajo presnovo gefitiniba in zmanjšajo njegovo koncentracijo v plazmi.
English: 375 18.1% vs 0%
Slovenian: 375 18,1 % v prim.
English: IRESSA 250 mg tablets gefitinib
Slovenian: IRESSA 250 mg tablete gefitinib
English: Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.
Slovenian: Snovi, ki občutno in dolgotrajno zvišajo pH v želodcu, lahko zmanjšajo koncentracijo gefitiniba v plazmi in tako zmanjšajo učinkovitost gefitiniba.
English: Haemorrhage, such as epistaxis and haematuria
Slovenian: Krvavitev, npr. epistaksa in hematurija
English: (48.0% vs 40.8%) p=0.0148
Slovenian: s 40,8 %) p = 0,0148
English: Haemorrhagic cystitis
Slovenian: Hemoragični cistitis
English: N FACT-L QoL improvement rate
Slovenian: N Delež izboljšanja kakovosti življenja po FACT-L
English: The tablet can be swallowed whole with some water or if dosing of whole tablets is not possible, tablets may be administered as a dispersion in water (non-carbonated).
Slovenian: Če uporaba celih tablet ni mogoča, se jih lahko uporabi v obliki disperzije v (negazirani) vodi.
English: 1350 6.8% vs 1.0%
Slovenian: 1350 6,8 % v prim.
English: OTHER
Slovenian: Mera
English: In the IFUM trial, mutation status was assessed in tumour and ctDNA samples derived from plasma, using the Therascreen EGFR RGQ PCR kit (Qiagen).
Slovenian: Tumorska DNK v obtoku (ctDNK - cirkulirajoča tumorska DNK) V preskušanju IFUM so mutacijsko stanje v vzorcih tumorja in iz plazme dobljenih vzorcih ctDNK testirali s kompletom Therascreen EGFR RGQ PCR (Qiagen).
English: Proportion of tumour M- that are Mby ctDNA)
Slovenian: Delež tumorskih M-, ki so M- po ctDNK
English: IRESSA contains lactose
Slovenian: Zdravilo IRESSA vsebuje laktozo
English: In a phase III open-label clinical trial (IPASS) in 1217 patients comparing IRESSA to carboplatin/paclitaxel doublet chemotherapy as first-line treatment in selected patients with advanced NSCLC in Asia, the incidence of ILD-type events was 2.6% on the IRESSA treatment arm versus 1.4% on the carboplatin/paclitaxel treatment arm.
Slovenian: Odprto klinično preskušanje III. faze (IPASS) je primerjalo zdravljenje z zdravilom IRESSA in dvotirno kemoterapijo s karboplatinom/paklitakselom kot zdravljenje prve linije pri 1217 izbranih bolnikih z napredovalim nedrobnoceličnim pljučnim rakom v Aziji.
English: IRESSA contains lactose.
Slovenian: Zdravilo IRESSA vsebuje laktozo.
English: 323 19.7% vs 8.7%
Slovenian: 323 19,7 % v prim.
English: <2D barcode carrying the unique identifier included.>
Slovenian: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: A further case of CNS haemorrhage has been reported in a child with an ependymoma from a trial with gefitinib alone.
Slovenian: V preskušanju gefitiniba samega so poročali o še enem primeru krvavitve v osrednje živčevje pri otroku z ependimomom.
English: 189 2.6% vs 0%
Slovenian: 189 2,6 % v prim.
English: Cystitis
Slovenian: Cistitis
English: Dry, red or itchy eyes
Slovenian: • suhe, pordele in srbeče oči
English: (14.6% vs 36.3%) p=0.0021
Slovenian: s 36,3 %) p = 0,0021
English: 26 37.5% vs 0%
Slovenian: 26 37,5 % v prim.
English: Ever smoker
Slovenian: Kajenje kdaj v življenju
English: Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Slovenian: Preglednica 6 Izidi učinkovitosti gefitiniba v primerjavi s placebom v študiji ISEL
English: 1466 9.1% vs 7.6%
Slovenian: 1466 9,1 % v prim.
English: Table 3 Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Slovenian: Preglednica 3 Izidi učinkovitosti gefitiniba v primerjavi s karboplatinom/paklitakselom v študiji IPASS
English: 780 43.3% vs 29.2%
Slovenian: 780 43,3 % v prim.
English: 3.7 m vs 5.9 m p=0.4449
Slovenian: s 5,9 m p = 0,4449
English: Both ctDNA and tumour samples were evaluable for 652 patients out of 1060 screened.
Slovenian: Pri 652 od 1060 presejanih bolnikov so bili za ocenjevanje primerni tako vzorci ctDNK kot vzorci tumorja.
English: 1217 43.0% vs 32.2%
Slovenian: 1217 43,0 % v prim.
English: There is no relevant use of gefitinib in the paediatric population in the indication of NSCLC.
Slovenian: Uporaba gefitiniba za indikacijo nedrobnocelični pljučni rak v pediatrični populaciji ni primerna.
English: 261 71.2% vs 47.3%
Slovenian: 261 71,2 % v prim.
English: An average 3.1-fold increase in exposure to gefitinib in patients with moderate and severe hepatic impairment was observed.
Slovenian: Pri bolnikih z zmerno in hudo okvaro jeter so ugotovili v povprečju 3,1-krat večjo izpostavljenost gefitinibu.
English: 9.5 m vs 5.5 m p=0.0100
Slovenian: s 5,5 m p = 0,0100
English: 1317 5.3% vs 1.6%
Slovenian: 1317 5,3 % v prim.
English: IRESSA 250 mg film-coated tablets gefitinib
Slovenian: IRESSA 250 mg filmsko obložene tablete gefitinib
English: No clinically relevant activity has been shown in patients with known EGFR mutation-negative tumours.
Slovenian: Pri bolnikih s tumorji brez mutacije EGFR (negativna mutacija EGFR) niso ugotovili klinično pomembnega delovanja.
English: The hepatocellular adenomas were also seen in a 2-year carcinogenicity study in mice, which demonstrated a small increased incidence of this finding in male mice at the mid dose, and in both male and female mice at the highest dose.
Slovenian: Hepatocelularne adenome so ugotovili tudi v 2-letni študiji kancerogenosti pri miših.
English: Gefitinib is a selective small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase and is an effective treatment for patients with tumours with activating mutations of the EGFR tyrosine kinase domain regardless of line of therapy.
Slovenian: Gefitinib je selektiven malomolekulski zaviralec receptorja za epidermalni rastni dejavnik tirozin-kinaze.
English: 6.4 m vs 6.0 m p=0.9131
Slovenian: s 6,0 m p = 0,9131
English: IRESSA 250 mg film-coated tablets
Slovenian: IRESSA 250 mg filmsko obložene tablete
English: 1143 6.2% vs 7.3%
Slovenian: 1143 6,2 % v prim.
English: 5.0 m vs 4.9 m p=0.2420
Slovenian: s 4,9 m p = 0,2420
English: 44 42.1% vs 21.1%
Slovenian: 44 42,1 % v prim.
English: • Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA Increase of creatinine levels in a blood test (related to kidney function) Cystitis (burning sensations during urination and frequent, urgent need to urinate)
Slovenian: • zvišanje bilirubina in drugega jetrnega encima, imenovanega aspartat-aminotransferaza, na preiskavi krvi; če je njuna raven previsoka, vam bo zdravnik morda naročil, da nehajte jemati zdravilo IRESSA
English: (70.2% vs 44.5%) p<0.0001
Slovenian: s 44,5 %) p < 0,0001
English: INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Slovenian: Pri nekaterih bolnikih, ki so sočasno jemali varfarin, so se pojavili zvišanje INR in/ali krvavitve (glejte poglavje 4.4).
English: Inflammation of the liver.
Slovenian: • vnetje trebušne slinavke.
English: Table 1 Adverse reactions
Slovenian: Preglednica 1: Neželeni učinki
English: 2.0 m vs 2.6 m p=0.5771
Slovenian: z 2,6 m p = 0,5771
English: 5.6 m vs 5.1 m p=0.0871
Slovenian: s 5,1 m p = 0,0871
English: In situations of concomitant treatment with potent inhibitors of CYP3A4 the patient should be closely monitored for gefitinib adverse reactions.
Slovenian: Med sočasnim zdravljenjem z močnimi zaviralci CYP3A4 je bolnike treba natančno kontrolirati glede neželenih učinkov gefitiniba.
English: (75.6% vs 53.9%) p=0.0003
Slovenian: s 53,9 %) p = 0,0003
English: 7.6 m vs 8.0 m p=0.7332
Slovenian: z 8,0 m p = 0,7332
English: International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Slovenian: Pri nekaterih bolnikih, ki so jemali varfarin skupaj z gefitinibom, so se pojavili zvišanje internacionalnega normaliziranega razmerja (INR) in/ali krvavitve (glejte poglavje 4.5).
English: 2.2 m vs 2.7 m p=0.4658
Slovenian: z 2,7 m p = 0,4658
English: 6.9 m vs 6.9 m p=0.9259
Slovenian: s 6,9 m p = 0,9259
English: 5.2 m vs 5.1 m p=0.2942
Slovenian: s 5,1 m p = 0,2942
English: The glass should be rinsed with half a glass of water, which should also be drunk.
Slovenian: Tableto dajte v pol kozarca vode za pitje, ne da bi jo zdrobili.
English: This medicine has been prescribed for you only.
Slovenian: • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: (51.5% vs 48.5%) p=0.3037
Slovenian: z 48,5 %) p = 0,3037
English: Elevations in aspartate aminotransferase, mainly mild to moderate
Slovenian: Zvišanje aspartat-aminotransferaze, v glavnem blago do zmerno Zvišanje celotnega bilirubina, v glavnem blago do zmerno
English: Talk to your doctor before taking this medicine if you are pregnant, may become pregnant or are breast-feeding.
Slovenian: Če ste noseči, če bi lahko zanosili ali če dojite, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: 10.4 m vs 12.2 m p=0.7711
Slovenian: z 12,2 m p = 0,7711
English: How to store IRESSA
Slovenian: Shranjevanje zdravila IRESSA
English: 4.4 m vs 2.2 m p=0.0084
Slovenian: z 2,2 m p = 0,0084
English: 253 6.6% vs 9.8%
Slovenian: 253 6,6 % v prim.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The proportion of ILD-type events with a fatal outcome was
Slovenian: Delež dogodkov tipa IBP s smrtnim izidom je bil 38,6 %.
English: An increased risk of cerebral haemorrhage in adult patients with NSCLC receiving gefitinib has not been established.
Slovenian: Pri odraslih bolnikih z nedrobnoceličnim rakom pljuč, ki dobivajo gefitinib, niso ugotovili večjega tveganja za možgansko krvavitev.
English: 1.7 m vs 2.6 m p=0.1353
Slovenian: z 2,6 m p = 0,1353
English: 4m p=0.1087
Slovenian: s 17,4 m p=0,1087
English: Nail problems
Slovenian: • težave z nohti
English: 14.2 m vs 16.6 m p=0.6043
Slovenian: s 16,6 m p = 0,6043
English: 18.8 m vs 17.
Slovenian: 18,8 m v prim.
English: Non-Asians
Slovenian: Neazijci
English: (20.2% vs 47.5%) p=0.0002
Slovenian: s 47,5 %) p = 0,0002
English: AstraZeneca AB SE-151 85
Slovenian: AstraZeneca AB SE-151 85 Södertälje Švedska
English: Odds of EGFR mutation
Slovenian: Obeti za mutacijo EGFR
English: 7.0 m vs 4.1 m p=0.0012
Slovenian: s 4,1 m p = 0,0012
English: There have been isolated reports of hepatic failure which in some cases led to fatal outcomes.
Slovenian: Opisani so bili posamezni primeri odpovedi jeter; nekateri so se končali s smrtjo.
English: The formation of O-desmethyl gefitinib has been shown, in vitro, to be via CYP2D6.
Slovenian: In vitro je ugotovljeno, da O-dezmetilgefitinib nastaja z delovanjem CYP2D6.
English: 10.8 m vs 3.8m p=0.7382
Slovenian: s 3,8 m p = 0,7382
English: EGFR mutation-positive
Slovenian: Pozitivna mutacija EGFR
English: Stomatitis, predominantly mild in nature (CTC grade 1)
Slovenian: Stomatitis, pretežno blag (1. stopnja po CTC)
English: 2.9 m vs 2.7 m p=0.0197
Slovenian: z 2,7 m p = 0,0197
English: In a phase I/II trial studying the use of gefitinib and radiation in paediatric patients, with newly diagnosed brain stem glioma or incompletely resected supratentorial malignant glioma, 4 cases (1 fatal) of Central Nervous System (CNS) haemorrhages were reported from 45 patients enrolled.
Slovenian: faze so raziskovali uporabo gefitiniba in obsevanja pri pediatričnih bolnikih z novoodkritim gliomom možganskega debla ali nepopolno reseciranim supratentorijskim malignim gliomom.
English: Discontinuation should be considered if changes are severe.
Slovenian: Če so spremembe hude, pride v poštev prekinitev zdravljenja.
English: 8.9 m vs 6.1 m p=0.0124
Slovenian: s 6,1 m p = 0,0124
English: 1.5 m vs 5.5 m p<0.0001
Slovenian: s 5,5 m p < 0,0001
English: 21.6 m vs 21.9 m
Slovenian: z 21,9 m
English: 6.1List of excipients
Slovenian: 6.1 Seznam pomožnih snovi
English: In a Japanese pharmacoepidemiological case control study in 3,159 patients with NSCLC receiving gefitinib or chemotherapy who were followed up for 12 weeks, the following risk factors for developing ILD (irrespective of whether the patient received IRESSA or chemotherapy) were identified: smoking, poor performance status (PS ≥ 2), CT scan evidence of reduced normal lung (≤ 50%), recent diagnosis of NSCLC (< 6 months), pre-existing ILD, older age (≥ 55 years old) and concurrent cardiac disease.
Slovenian: Kot dejavnike tveganja za nastanek IBP (ne glede na to, ali je bolnik dobival zdravilo IRESSA ali kemoterapijo) so ugotovili: kajenje, slab zmogljivostni status (zmogljivostni status ≥ 2), računalniško-tomografske (CT) znake zmanjšanja normalnih pljuč (≤ 50 %), nedavno postavljeno
English: 2.7 m vs 2.6 m p=0.0707
Slovenian: z 2,6 m p = 0,0707
English: 2.0 m vs 2.7 m p=0.1041
Slovenian: z 2,7 m p = 0,1041
English: HR 1.01
Slovenian: z 1,0 %
English: EGFR mutation-negative
Slovenian: Negativna mutacija EGFR
English: EGFR mutationunknown
Slovenian: Neznana mutacija EGFR