FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly No dose adjustment is required on the basis of patient age (see section 5.2).
Croatian: Nije potrebna prilagodba doze s obzirom na dob bolesnika (vidjeti dio 5.2).
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Croatian: Obavijestite liječnika ili ljekarnika ako uzimate,nedavnosteuzimali, ili biste mogli uzetibilo koje druge lijekove.
English: The dispersion can also be administered through a naso-gastric or gastrostomy tube.
Croatian: Disperzija se može primijeniti i kroz nazogastričnu sondu ili gastrostomu.
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).
Croatian: 1 koji su imali uznapredovali NSCLC (stadij IIIB ili IV) s histološkom slikom adenokarcinoma, a koji su bili bivši laki pušači (prestali su pušiti prije 15 ili više godina, a pušili su < 10 kutija godišnje) ili nikada nisu pušili (vidjeti Tablicu 3).
English: Most NSCLC tumours with sensitising EGFR kinase mutations eventually develop resistance to IRESSA treatment, with a median time to disease progression of 1 year.
Croatian: Većina NSCLC-a sa senzibilizirajućim mutacijama EGFR kinaze naposljetku razvije rezistenciju na liječenje lijekom IRESSA, s medijanom vremena do progresije bolesti od 1 godine.
English: Gefitinib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown.
Croatian: Gefitinib in vitro inhibira transportni protein BCRP (breast cancer resistance protein), no klinički značaj tog nalaza nije poznat.
English: Smoking status <0.0001 6.5 times higher in never smokers than ever-smokers
Croatian: <0,0001 6,5 puta veći u osoba koje nikada nisu pušile u odnosu na osobe koje su ikada pušile
English: If a tumour sample is not evaluable, then circulating tumour DNA (ctDNA) obtained from a blood (plasma) sample may be used.
Croatian: Ako se uzorak tumora ne može ocijeniti, može se upotrijebiti cirkulirajuća tumorska DNK (engl. circulating tumour DNK, ctDNK) dobivena iz uzorka krvi (plazme).
English: The objective response rate (ORR) in those patients who were tumour and ctDNA mutation positive was 77% (95% CI: 66% to 86%) and in those who were tumour only mutation positive 60% (95% CI: 44% to 74%).
Croatian: Stopa objektivnog odgovora (engl. objective response rate, ORR) kod bolesnika kojima su i tumor i ctDNK bili pozitivni na mutaciju iznosila je 77% (95% CI: 66% do 86%), a kod onih kojima je samo tumor bio pozitivan na mutaciju 60% (95% CI: 44% do 74%).
English: In most cases this is associated with other known risk factors, including concomitant medications such as steroids or NSAIDS, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.
Croatian: Većinom je to udruženo s drugim poznatim čimbenicima rizika, uključujući istodobnu primjenu drugih lijekova kao što su steroidi ili NSAIL, postojeću anamnezu gastrointestinalnih ulceracija, dob, pušenje ili metastaze u crijevima na mjestima perforacije.
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).
Croatian: Dostupni su samo ograničeni podaci u bolesnika s klirensom kreatinina  20 ml/min te se u tih bolesnika savjetuje oprez (vidjeti dio 5.2).
English: Patients taking warfarin and gefitinib concomitantly should be monitored regularly for changes in prothrombin time (PT) or INR.
Croatian: Bolesnike koji istodobno uzimaju varfarin i gefitinib treba redovito nadzirati kako bi se uočile promjene protrombinskog vremena (PV) ili INR-a.
English: Each tablet contains 163.5 mg of lactose (as monohydrate).
Croatian: Jedna tableta sadržava 163,5 mg laktoze (u obliku hidrata)
English: LCS symptom improvement rate
Croatian: Stopa poboljšanja simptoma prema LCS
English: Driving and using machines If you feel weak whilst taking this medicine, take care driving or using tools or machines.
Croatian: Ako tijekom uzimanja ovog lijeka osjećate slabost, budite oprezni prilikom vožnje ili korištenja alata i strojeva.
English: Approximately 8% of patients had a severe ADR (common toxicity criteria (CTC) grade 3 or 4).
Croatian: Približno 8% bolesnika imalo je teške nuspojave (stupnja 3 ili 4 prema općim kriterijima toksičnosti (common toxicity criteria, CTC)).
English: Pancreatitis Gastrointestinal perforation
Croatian: Pankreatitis Gastrointestinalna perforacija
English: Cases with fatal outcomes have been reported
Croatian: Prijavljeni su slučajevi sa smrtnim ishodom
English: NR vs 4.3 m
Croatian: ND vs 4,3 m
English: The higher average exposures that could be achieved by individuals with no active CYP2D6 may be clinically relevant since adverse effects are related to dose and exposure.
Croatian: Više prosječne izloženosti koje su se mogle postići kod pojedinaca s neaktivnim CYP2D6 mogu biti klinički značajne, jer su nuspojave povezane s dozom i izloženošću.
English: N Number of patients randomised
Croatian: N Broj randomiziranih bolesnika
English: If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking IRESSA.
Croatian: Ako se nešto od navedenog odnosi na Vas, ili niste sigurni, porazgovarajte s liječnikom ili ljekarnikom prije nego uzmete lijek IRESSA.
English: Film-coated tablets (tablet).
Croatian: Filmom obložene tablete (tableta).
English: Gefitinib binds to serum albumin and alpha 1-acid glycoprotein.
Croatian: Gefitinib se veže na serumski albumin i alfa-1-kiseli glikoprotein.
English: Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
Croatian: • alergijska reakcija (često), osobito ako simptomi uključuju oticanje lica, usana, jezika ili grla, otežano gutanje, koprivnjaču i otežano disanje.
English: Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
Croatian: Bolesnici ne smiju uzeti dvostruku dozu (dvije doze odjednom) kako bi nadoknadili propuštenu dozu.
English: Warnings and precautions Talk to your doctor or pharmacist before taking IRESSA if you have ever had any other lung problems.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek IRESSA ako ste ikad imali drugih tegoba s plućima.
English: Administration of gefitinib once daily results in 2- to 8-fold accumulation, with steady state exposures achieved after 7 to 10 doses.
Croatian: Primjena gefitiniba jednom na dan dovodi do nakupljanja od 2 do 8 puta, a izloženost u stanju dinamičke ravnoteže postiže se nakon 7 do 10 doza.
English: The role of CYP2D6 in the metabolic clearance of gefitinib has been evaluated in a clinical trial in healthy volunteers genotyped for CYP2D6 status.
Croatian: Uloga CYP2D6 u metaboličkom klirensu gefitiniba ispitana je u kliničkom ispitivanju na zdravim dobrovoljcima genotipiziranima radi određivanja statusa CYP2D6.
English: Date of first authorisation: 24/06/2009 Date of latest renewal: 23/04/2014
Croatian: Datum posljednje obnove: 23.04.2014.
English: Numbers in square brackets are 95% confidence intervals for HR c Stratified log-rank test for overall; otherwise cox proportional hazards model d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth
Croatian: Brojevi u uglatim zagradama predstavljaju 95%-tni interval pouzdanosti za omjer rizika c Stratificirani log-rank test za ukupno; u prozivnom Coxov model razmjernih rizika d Azijatsko porijeklo ne obuhvaća bolesnike indijskog podrijetla i odnosi se na rasno podrijetlo skupine bolesnika, a ne nužno na njihovo mjesto rođenja
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.
Croatian: Hepatocelularni adenomi opaženi su i u dvogodišnjem ispitivanju karcinogenosti u miševa, u kojemu je ustanovljena malo povećana incidencija ovog nalaza u mužjaka pri srednjoj dozi, a pri najvišoj dozi i u mužjaka i u ženki.
English: Patients with poorly tolerated diarrhoea or skin adverse reactions may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by reinstatement of the 250 mg dose (see section 4.8).
Croatian: Bolesnicima koji teško podnose proljev ili kožne nuspojave može se uspješno pomoći ako im se liječenje nakratko prekine (do 14 dana), a zatim ponovno počne davati doza od 250 mg (vidjeti dio 4.8).
English: From analyses of population pharmacokinetic data in cancer patients, no relationships were identified between predicted steady-state trough concentration and patient age, body weight, gender, ethnicity or creatinine clearance (above 20 ml/min).
Croatian: Iz analiza podataka o populacijskoj farmakokinetici u bolesnika s rakom, nije utvrđena povezanost između predviđene najniže koncentracije u stanju dinamičke ravnoteže i bolesnikove dobi, tjelesne težine, spola, etničke pripadnosti te klirensa kreatinina (iznad 20 ml/min).
English: It is not known whether gefitinib is secreted in human milk.
Croatian: Nije poznato izlučuje li se gefitinib u majčino mlijeko u ljudi.
English: Cases with fatal outcomes have been reported.
Croatian: Prijavljeni su slučajevi sa smrtnim ishodom.
English: There have been isolated reports of hepatic failure which in some cases led to fatal outcomes.
Croatian: Postoje izolirana izvješća o zatajenju jetre koje je u nekim slučajevima imalo smrtni ishod.
English: Herbal remedies containing St John's wort (Hypericum perforatum, used for depression and anxiety).
Croatian: Biljne lijekove koji sadrže gospinu travu (Hypericum perforatum, koja se koristi za liječenje depresije i tjeskobe).
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.
Croatian: Kada se razmatra primjena lijeka IRESSA za liječenje lokalno uznapredovalog ili metastatskog NSCLC-a, važno je pokušati procijeniti status mutacije EGFR-a u tumorskom tkivu kod svih bolesnika.
English: An increased risk of cerebral haemorrhage in adult patients with NSCLC receiving gefitinib has not been established.
Croatian: Nije utvrđen povećani rizik od moždanog krvarenja u odraslih bolesnika s NSCLC-om koji primaju gefitinib.
English: If ILD is confirmed, IRESSA should be discontinued and the patient treated appropriately.
Croatian: Ako se potvrdi ILD, treba prekinuti liječenje lijekom IRESSA i bolesnika liječiti na odgovarajući način.
English: Data from 4 patients with severe hepatic impairment due to liver metastases suggested that steady-state exposures in these patients are also similar to those in patients with normal hepatic function.
Croatian: Podaci o 4 bolesnika s teškim oštećenjem jetrene funkcije uslijed metastaza u jetri ukazuju da je i u tih bolesnika izloženost u stanju dinamičke ravnoteže slična kao u bolesnika s normalnom funkcijom jetre.
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.
Croatian: Ako se u bolesnika pogoršaju respiratorni simptomi kao što su dispneja, kašalj i vrućica, liječenje lijekom IRESSA treba prekinuti i bolesnik se mora odmah pregledati.
English: Tablets are brown, round, biconvex, impressed with “IRESSA 250” on one side and plain on the other.
Croatian: Tablete su smeđe, okrugle, bikonveksne, s utisnutom oznakom "IRESSA 250" na jednoj i bez oznaka na drugoj strani.
English: Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy (see section 4.3).
Croatian: Gefitinib je kontraindiciran tijekom dojenja te se stoga dojenje mora prekinuti tijekom liječenja gefitinibom (vidjeti dio 4.3).
English: Gefitinib has a mean steady-state volume of distribution of 1400 l indicating extensive distribution into tissue.
Croatian: Gefitinib ima srednji volumen raspodjele u stanju dinamičke ravnoteže od 1400 l, što ukazuje na opsežnu raspodjelu u tkivu.
English: Time to treatment failure ab
Croatian: Vrijeme do prestanka odgovora na liječenje ab
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Croatian: Bolesnike u kojih su prisutni znakovi i simptomi koji upućuju na keratitis, akutni ili pogoršani: upale očiju, suzenje, osjetljivost na svjetlost, zamućeni vid, bol i/ili crvenilo očiju, treba odmah uputiti specijalistu oftalmologu.
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).
Croatian: U zbirnim podacima iz kliničkih ispitivanja faze III ISEL, INTEREST i IPASS (2462 bolesnika liječena lijekom IRESSA), najčešće prijavljene nuspojave, koje se javljaju u više od 20% bolesnika, su proljev i kožne reakcije (uključujući osip, akne, suhu kožu i svrbež).
English: Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin
Croatian: • kožne reakcije kao što je osip u obliku akni, koji ponekad svrbi, a koža je suha i/ili napukla
English: 30 film-coated tablets.
Croatian: 30 filmom obloženih tableta.
English: Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA
Croatian: • porast vrijednosti jetrenog enzima koji se zove alanin aminotransferaza u nalazima krvnih pretraga; ako su vrijednosti previsoke, liječnik Vam može reći da prestanete uzimati lijek
English: No dose adjustment is required in patients with impaired renal function at creatinine clearance > 20 ml/min.
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem bubrežne funkcije s klirensom kreatinina > 20 ml/min.
English: In the ISEL trial, the incidence of ILD-type events in the overall population was approximately 1% in both treatment arms.
Croatian: U kliničkom ispitivanju ISEL incidencija nuspojava tipa ILD-a u ukupnoj populaciji iznosila je približno 1% u obje liječene skupine.
English: Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
Croatian: Inhibitore protonske pumpe, antagoniste H2-receptora i antacide (za liječenje čira, probavnih tegoba, žgaravice i smanjenje kiseline u želucu).
English: Asians
Croatian: Azijati
English: The ORR according to investigator review was 70% and the median PFS was 9.7 months.
Croatian: Stopa objektivnog odgovora bila je prema ocjeni istraživača 70%, a medijan vremena do progresije bolesti (engl. progression-free survival, PFS) bio je 9,7 mjeseci.
English: Hazard Ratio (Gefitinib versus Docetaxel) and 95% CI
Croatian: Omjer rizika (gefitinib u odnosu na docetaksel) i 95% CI
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
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.
Croatian: Gefitinib se uglavnom izlučuje u obliku metabolita putem stolice, a eliminacija gefitiniba i metabolita putem bubrega iznosi manje od 4% primijenjene doze.
English: A 2-year carcinogenicity study in rats resulted in a small but statistically significant increased incidence of hepatocellular adenomas in both male and female rats and mesenteric lymph node haemangiosarcomas in female rats at the highest dose (10 mg/kg/day) only.
Croatian: Dvogodišnje ispitivanje karcinogenosti u štakora pokazalo je malo, ali statistički značajno, povećanu incidenciju hepatocelularnih adenoma i u mužjaka i u ženki te hemangiosarkoma mezenterijalnih limfnih čvorova u ženki samo pri najvišoj dozi (10 mg/kg/dan).
English: The signs may include redness, pain, ulcers, blisters, and shedding of the skin.
Croatian: Znakovi mogu uključivati crvenilo, bol, vrijedove, mjehure i guljenje kože.
English: If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water.
Croatian: Ako imate teškoća prilikom gutanja tablete, rastopite je u pola čaše negazirane vode.
English: Both ctDNA and tumour samples were evaluable for 652 patients out of 1060 screened.
Croatian: I uzorak ctDNK i uzorak tumora bilo je moguće ocijeniti kod 652 bolesnika od njih 1060 koji su pristupili probiru.
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).
Croatian: U jednom ispitivanju u zdravih dobrovoljaca u kojih je želučani pH bio održavan iznad pH 5, izloženost gefitinibu smanjena je za 47%, najvjerojatnije uslijed slabije topljivosti gefitiniba u želucu (vidjeti dijelove 4.4 i 4.5).
English: Gefitinib and metabolites of gefitinib accumulated in milk of lactating rats (see section 5.3).
Croatian: Gefitinib i njegovi metaboliti izlučuju se u mlijeko štakorica u laktaciji (vidjeti dio 5.3).
English: Proportion of tumour M+ that are M+ by ctDNA
Croatian: Udio M+ tumora kod kojih je ctDNK bio M+
English: Exposure to gefitinib is not significantly altered by food.
Croatian: Hrana ne mijenja značajno izloženost gefitinibu.
English: HR Hazard ratio (hazard ratios <1 favour IRESSA)
Croatian: HR Omjer hazarda (omjer hazarda < 1 ide u korist lijeka IRESSA)
English: Dry, red or itchy eyes
Croatian: • suhoća, crvenilo ili svrbež očiju
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.
Croatian: Gefitinib je selektivni mali molekulski inhibitor tirozin kinaze receptora epidermalnog faktora rasta te je učinkovit u liječenju bolesnika koji imaju tumor s aktivirajućom mutacijom na domeni tirozin kinaze EGFR-a, neovisno o liniji liječenja.
English: This may give the appearance of bruising or patches of non-blanching rash on the skin.
Croatian: Ona može imati izgled modrica ili područja osipa na koži koji ne blijedi.
English: If you take more IRESSA than you should If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.
Croatian: Ako ste uzeli više tableta nego što ste trebali, odmah se obratite liječniku ili ljekarniku.
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).
Croatian: U ispitivanju IFUM, status mutacije ocjenjivao se na uzorcima tumora i uzorcima ctDNK dobivenima iz plazme, korištenjem kompleta testnih reagensa Therascreen EGFR RGQ PCR Kit (Qiagen).
English: Each tablet contains 3.86 mg of sodium.
Croatian: Jedna tableta sadržava 3.86 mg natrija.
English: The recommended dose is one 250mg tablet per day.
Croatian: • Preporučena doza je jedna tableta od 250 mg na dan.
English: The results of an in vitro phototoxicity study demonstrated that gefitinib may have phototoxicity potential.
Croatian: Rezultati ispitivanja fototoksičnosti in vitro pokazali su da gefitinib može imati fototoksični potencijal.
English: Clinical experience has not shown a causal association between QT prolongation and gefitinib.
Croatian: Kliničko iskustvo nije pokazalo uzročnu povezanost između QT produljenja i primjene gefitiniba.
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.
Croatian: Gefitinib je ispitan u kliničkom ispitivanju provedenom u 41 bolesnika sa solidnim tumorom i normalnom funkcijom jetre, ili umjerenim ili teškim oštećenjem jetrene funkcije (klasificirano prema početnim stupnjevima općeg kriterija toksičnosti (CTC) za AST, alkalnu fosfatazu i bilirubin) uslijed metastaza u jetri.
English: This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.
Croatian: To je bolest u kojoj se u tkivu pluća stvaraju zloćudne stanice (stanice raka).
English: In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Croatian: In vitro ispitivanja su pokazala da gefitinib ima ograničeni potencijal za inhibiciju CYP2D6.
English: In this study IRESSA exposure did not increase with increasing dose, adverse events were mostly mild to moderate in severity, and were consistent with the known safety profile of IRESSA.
Croatian: U tom se ispitivanju izloženost lijeku IRESSA nije povećala s povećanjem doze, a nuspojave su uglavnom bile blage do umjereno teške i sukladne poznatom sigurnosnom profilu lijeka IRESSA.
English: Adverse reactions have been assigned to the frequency categories in Table 1 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 IRESSA-treated patients).
Croatian: Nuspojavama su kategorije učestalosti u Tablici 1 određene kad je to bilo moguće na temelju incidencije usporedivih prijava nuspojava u zbirnim podacima iz kliničkih ispitivanja faze III ISEL, INTEREST i IPASS (2462 bolesnika liječena lijekom IRESSA).
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).
Croatian: Nema podataka o istodobnom liječenju s inhibitorom CYP2D6, ali snažni inhibitori ovog enzima mogu uzrokovati približno dvostruko povećanje plazmatske koncentracije gefitiniba u bolesnika koji su opsežni metabolizatori CYP2D6 (vidjeti dio 5.2).
English: HR 0.68 [0.58 to 0.81] 6.6 m vs 5.8 m p<0.0001
Croatian: HR 0,68 [0,58 do 0,81] 6,6 m vs 5,8 m p<0,0001
English: Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases (see section 5.2).
Croatian: Koncentracije u plazmi nisu bile povišene u bolesnika s povišenim vrijednostima aspartat transaminaze (AST), alkalne fosfataze ili bilirubina uslijed metastaza u jetri (vidjeti dio 5.2).
English: Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes.
Croatian: • problemi s očima (manje često), kao što su bol, crvenilo, suzenje očiju, osjetljivost na svjetlost, promjene vida ili urastanje trepavica.
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].
Croatian: Postoje robusni podaci o odgovoru čestih mutacija koje aktiviraju EGFR (delecije u eksonu 19; L858R), koji potvrđuju osjetljivost na gefitinib; primjerice, omjer hazarda (engl. hazard ratio, HR) (95% CI) za preživljenje bez progresije bolesti iznosi 0,489 (0,336; 0,710) uz gefitinib naspram dvostruke kemoterapije [WJTOG3405].
English: There is no relevant use of gefitinib in the paediatric population in the indication of NSCLC.
Croatian: Nema relevantne primjene gefitiniba u pedijatrijskoj populaciji u indikaciji raka pluća ne-malih stanica (NSCLC).