natgillin/translations-raw huggingface dataset:
Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy (see section 4.3). 
Gefitinib je kontraindiciran tijekom dojenja te se stoga dojenje mora prekinuti tijekom liječenja gefitinibom (vidjeti dio 4.3).
Gefitinib has a mean steady-state volume of distribution of 1400 l indicating extensive distribution into tissue. 
Gefitinib ima srednji volumen raspodjele u stanju dinamičke ravnoteže od 1400 l, što ukazuje na opsežnu raspodjelu u tkivu.
Time to treatment failure ab 
Vrijeme do prestanka odgovora na liječenje ab
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. 
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.
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). 
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).
Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin 
• kožne reakcije kao što je osip u obliku akni, koji ponekad svrbi, a koža je suha i/ili napukla
30 film-coated tablets. 
30 filmom obloženih tableta.
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 
• 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
No dose adjustment is required in patients with impaired renal function at creatinine clearance > 20 ml/min. 
Nije potrebna prilagodba doze u bolesnika s oštećenjem bubrežne funkcije s klirensom kreatinina > 20 ml/min.
In the ISEL trial, the incidence of ILD-type events in the overall population was approximately 1% in both treatment arms. 
U kliničkom ispitivanju ISEL incidencija nuspojava tipa ILD-a u ukupnoj populaciji iznosila je približno 1% u obje liječene skupine.
Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach). 
Inhibitore protonske pumpe, antagoniste H2-receptora i antacide (za liječenje čira, probavnih tegoba, žgaravice i smanjenje kiseline u želucu).
Asians 
Azijati
The ORR according to investigator review was 70% and the median PFS was 9.7 months. 
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.
Hazard Ratio (Gefitinib versus Docetaxel) and 95% CI 
Omjer rizika (gefitinib u odnosu na docetaksel) i 95% CI
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
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. 
Gefitinib se uglavnom izlučuje u obliku metabolita putem stolice, a eliminacija gefitiniba i metabolita putem bubrega iznosi manje od 4% primijenjene doze.
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. 
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).
The signs may include redness, pain, ulcers, blisters, and shedding of the skin. 
Znakovi mogu uključivati crvenilo, bol, vrijedove, mjehure i guljenje kože.
If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water. 
Ako imate teškoća prilikom gutanja tablete, rastopite je u pola čaše negazirane vode.
Both ctDNA and tumour samples were evaluable for 652 patients out of 1060 screened. 
I uzorak ctDNK i uzorak tumora bilo je moguće ocijeniti kod 652 bolesnika od njih 1060 koji su pristupili probiru.
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). 
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).
Gefitinib and metabolites of gefitinib accumulated in milk of lactating rats (see section 5.3). 
Gefitinib i njegovi metaboliti izlučuju se u mlijeko štakorica u laktaciji (vidjeti dio 5.3).
Proportion of tumour M+ that are M+ by ctDNA 
Udio M+ tumora kod kojih je ctDNK bio M+
Exposure to gefitinib is not significantly altered by food. 
Hrana ne mijenja značajno izloženost gefitinibu.
HR Hazard ratio (hazard ratios <1 favour IRESSA) 
HR Omjer hazarda (omjer hazarda < 1 ide u korist lijeka IRESSA)
Dry, red or itchy eyes 
• suhoća, crvenilo ili svrbež očiju
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. 
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.
This may give the appearance of bruising or patches of non-blanching rash on the skin. 
Ona može imati izgled modrica ili područja osipa na koži koji ne blijedi.
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. 
Ako ste uzeli više tableta nego što ste trebali, odmah se obratite liječniku ili ljekarniku.
In the IFUM trial, mutation status was assessed in tumour and ctDNA samples derived from plasma, using the Therascreen EGFR RGQ PCR kit (Qiagen). 
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).
Each tablet contains 3.86 mg of sodium. 
Jedna tableta sadržava 3.86 mg natrija.
The recommended dose is one 250mg tablet per day. 
• Preporučena doza je jedna tableta od 250 mg na dan.
The results of an in vitro phototoxicity study demonstrated that gefitinib may have phototoxicity potential. 
Rezultati ispitivanja fototoksičnosti in vitro pokazali su da gefitinib može imati fototoksični potencijal.
Clinical experience has not shown a causal association between QT prolongation and gefitinib. 
Kliničko iskustvo nije pokazalo uzročnu povezanost između QT produljenja i primjene gefitiniba.
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. 
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.
This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung. 
To je bolest u kojoj se u tkivu pluća stvaraju zloćudne stanice (stanice raka).
In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6. 
In vitro ispitivanja su pokazala da gefitinib ima ograničeni potencijal za inhibiciju CYP2D6.
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. 
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.
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). 
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).
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). 
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).
HR 0.68 [0.58 to 0.81] 6.6 m vs 5.8 m p<0.0001 
HR 0,68 [0,58 do 0,81] 6,6 m vs 5,8 m p<0,0001
Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases (see section 5.2). 
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).
Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes. 
• problemi s očima (manje često), kao što su bol, crvenilo, suzenje očiju, osjetljivost na svjetlost, promjene vida ili urastanje trepavica.
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]. 
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].
There is no relevant use of gefitinib in the paediatric population in the indication of NSCLC. 
Nema relevantne primjene gefitiniba u pedijatrijskoj populaciji u indikaciji raka pluća ne-malih stanica (NSCLC).
Liver function test abnormalities (including increases in alanine aminotransferase, aspartate aminotransferase, bilirubin) have been observed, uncommonly presenting as hepatitis (see section 4.8). 
Primijećeni su poremećaji u testovima jetrene funkcije (uključujući povišene vrijednosti alanin aminotransferaze, aspartat aminotransferaze, bilirubina), koji su se manje često manifestirali kao hepatitis (vidjeti dio 4.8).
IRESSA is a round brown tablet marked with ‘IRESSA 250' on one side and plain on the other. 
IRESSA tableta je okrugla i smeđa, s utisnutom oznakom "IRESSA 250" na jednoj i bez oznaka na drugoj strani.
Data from phase II clinical trials, where gefitinib and vinorelbine have been used concomitantly, indicate that gefitinib may exacerbate the neutropenic effect of vinorelbine. 
Podaci iz kliničkih ispitivanja faze II, u kojima su se istodobno primjenjivali gefitinib i vinorelbin, ukazuju da gefitinib može pojačati neutropenijski učinak vinorelbina.
When administered to the rat throughout gestation and parturition, there was a reduction in pup survival at a dose of 20 mg/kg/day. 
Prilikom primjene u štakora tijekom gestacije i okota, došlo je do smanjenog preživljenja mladunčadi pri dozi od 20 mg/kg/dan.
Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration. 
Nakon peroralne primjene, apsorpcija gefitiniba je umjereno spora te se vršne koncentracije gefitiniba u plazmi u pravilu postižu 3 do 7 sati nakon primjene.
Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib. 
Bolesnici s umjerenim do teškim oštećenjem jetrene funkcije (Child-Pugh B ili C) uslijed ciroze imaju povišene koncentracije gefitiniba u plazmi.
Concomitant administration with potent inhibitors of CYP3A4 activity (e.g. ketoconazole, posaconazole, voriconazole, protease inhibitors, clarithromycin, telithromycin) may increase gefitinib plasma concentrations. 
Istodobna primjena sa snažnim inhibitorima aktivnosti CYP3A4 (npr. ketokonazol, posakonazol, vorikonazol, inhibitori proteaze, klaritromicin, telitromicin) može povećati koncentracije gefitiniba u plazmi.
Hepatotoxicity and liver impairment 
Hepatotoksičnost i oštećenje jetre
However, in the rabbit, there were reduced foetal weights at 20 mg/kg/day and above. 
Međutim, u zečeva je došlo do smanjenja težine fetusa pri dozama od 20 mg/kg/dan i višim.
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. 
U otvorenom kliničkom ispitivanju faze III (IPASS) s 1217 bolesnika, u kojem se uspoređivao lijek IRESSA s dvostrukom kemoterapijom karboplatinom/paklitakselom u prvoj liniji liječenja u odabranih bolesnika s uznapredovalim NSCLC-om u Aziji, incidencija nuspojava tipa ILD-a iznosila je 2,6% u skupini liječenoj lijekom IRESSA u usporedbi s 1,4% u skupini koja je primala karboplatin/paklitaksel.
Three blisters are combined with an aluminium foil laminate over-wrap in a carton. 
Tri blistera su pakirana u zajednički zaštitni omot od slojevite aluminijske folije, u kutiji.
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. 
Učestalost nuspojava koje se odnose na odstupanja laboratorijskih vrijednosti temelji se na bolesnicima koji su imali promjene relevantnih laboratorijskih parametara za 2 ili više CTC stupnjeva u odnosu na početne vrijednosti.
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. 
Pokazalo se da su nakon dnevne primjene doze od 250 mg gefitiniba, vrijeme do postizanja stanja dinamičke ravnoteže, ukupan klirens iz plazme (CmaxSS) i izloženost u stanju dinamičke ravnoteže (AUC24SS) bili slični u skupini s normalnom i onoj s umjereno oštećenom funkcijom jetre.
Anorexia mild or moderate (CTC grade 1 or 2) 
Anoreksija blaga ili umjerena (CTC stupanj 1 ili 2)
Interstitial lung disease (1.3%), often severe (CTC grade 3-4). 
Intersticijska bolest pluća (1,3%), često teška (CTC stupanj 3-4).
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 
Kožne reakcije, uglavnom blage ili umjerene (CTC stupanj 1 ili 2) pustulozni osip na eritematoznoj podlozi, ponekad uz svrbež i suhu kožu uključujući i fisure kože
Impaired liver function due to cirrhosis has been shown to lead to increased plasma concentrations of gefitinib (see section 5.2). 
Pokazalo se da oštećena funkcija jetre uslijed ciroze dovodi do povišenja koncentracije gefitiniba u plazmi (vidjeti dio 5.2).
One ILD-type event was fatal, and this occurred in a patient receiving placebo. 
Jedan slučaj tipa ILD-a imao je smrtni ishod, a radilo se o bolesniku koji je primao placebo.
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). 
• Drugi sastojci (pomoćne tvari) su: laktoza hidrat, mikrokristalična celuloza (E460), umrežena karmelozanatrij, povidon (K29-32) (E1201), natrijev laurilsulfat, magnezijev stearat, hipromeloza (E464), makrogol 300, titanijev dioksid (E171), žuti željezov oksid (E172) i crveni željezov oksid (E172).
In a post-marketing surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving gefitinib was 5.8%. 
U ispitivanju praćenja nakon stavljanja lijeka na tržište u Japanu (3350 bolesnika) zabilježena je stopa nuspojava tipa ILD-a od 5,8% u bolesnika koji su primali gefitinib.
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. 
Većina prijavljenih nuspojava tipa ILD-a javljala se u bolesnika azijskog etničkog podrijetla, pri čemu je incidencija ILD-a u bolesnika azijskog podrijetla koji su primali gefitinib iznosila oko 3%, a u onih koji su primali placebo oko 4%.
Such an increase might potentially be relevant for CYP2D6 substrates with narrow therapeutic index. 
Takav porast se može pokazati značajnim za supstrate CYP2D6 s uskim terapijskim indeksom.
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. 
Glavni utvrđeni metabolit je O-demetil gefitinib, koji 14 puta slabije od gefitiniba inhibira stanični rast stimuliran EGFR-om i nema inhibitornog djelovanja na rast tumorskih stanica u miševa.
Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite. 
• dehidracija (često) uzrokovana dugotrajnim ili teškim proljevom, povraćanje, mučnina ili gubitak apetita.
Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6. 
Djelatne tvari čija se koncentracija u plazmi može promijeniti djelovanjem gefitiniba In vitro studije su pokazale da gefitinib ima ograničen potencijal za inhibiciju CYP2D6.
During treatment with gefitinib, asthenia has been reported. 
Tijekom liječenja gefitinibom zabilježena je astenija.
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. 
U otvorenom kliničkom ispitivanju faze I u kojem se ispitivala primjena jednokratne doze gefitiniba od 250 mg bolesnicima s blagim, umjerenim ili teškim oštećenjem jetrene funkcije uslijed ciroze (prema Child-Pugh klasifikaciji), zabilježena je povećana izloženost u svim skupinama u odnosu na zdrave ispitanike u kontrolnoj skupini.
A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day. 
Opaženo je smanjenje plodnosti ženki štakora pri dozi od 20 mg/kg/dan.
In vitro data indicate that CYP3A4 and CYP2D6 are the major P450 isozyme involved in the oxidative metabolism of gefitinib. 
Podaci dobiveni in vitro ukazuju da su CYP3A4 i CYP2D6 glavni izoenzimi citokroma P450 uključeni u oksidativni metabolizam gefitiniba.
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. 
U farmakoepidemiološkom ispitivanju slučajeva s kontrolama provedenom u Japanu na 3159 bolesnika s NSCLC-om liječenih gefitinibom ili kemoterapijom koji su praćeni tijekom 12 tjedana, utvrđeni su sljedeći čimbenici rizika za razvoj ILD-a (bez obzira jesu li bolesnici primali lijek IRESSA ili kemoterapiju): pušenje, loše opće stanje (PS (performance status) ≥ 2), CT-om dokazano smanjenje normalnog plućnog tkiva (≤ 50%), nedavno dijagnosticiran NSCLC (< 6 mjeseci), otprije postojeći ILD, starija dob (≥ 55 godina) te istodobna srčana bolest.
Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1) 
Konjunktivitis, blefaritis i suhoća oka*, uglavnom blagi (CTC stupanj 1)
In the INTEREST trial, the incidence of ILD type events was 1.4% (10) patients in the gefitinib group versus 1.1% (8) patients in the docetaxel group. 
U kliničkom ispitivanju INTEREST incidencija nuspojava tipa intersticijske bolesti pluća iznosila je 1,4% (10) bolesnika u skupini liječenoj gefitinibom u odnosu na 1,1% (8) bolesnika u skupini koja je primala docetaksel.
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). 
Stoga istodobna primjena induktora CYP3A4 (npr. fenitoin, karbamazepin, rifampicin, barbiturati ili biljni pripravci koji sadrže gospinu travu/Hypericum perforatum) može smanjiti djelotvornost liječenja te se treba izbjegavati (vidjeti dio 4.5).
Primary endpoint overall survival abc 
Primarna mjera ishoda: ukupno preživljenje abc
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. 
U kliničkom ispitivanju faze I/II u kojem se ispitivala primjena gefitiniba i zračenja u pedijatrijskih bolesnika s novodijagnosticiranim gliomom moždanog debla ili nepotpuno reseciranim supratentorijalnim malignim gliomom, prijavljena su 4 slučaja (1 sa smrtnim ishodom) krvarenja u središnjem živčanom sustavu (SŽS) na 45 uključenih bolesnika.
HR NC 
HR NI
The recommended posology of IRESSA is one 250 mg tablet once a day. 
Preporučena doza lijeka IRESSA je jedna tableta od 250 mg jednom na dan.
Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort/ Hypericum perforatum) should be avoided. 
Treba izbjegavati istodobnu primjenu lijekova koji induciraju CYP3A4 (npr. fenitoin, karbamazepin, rifampicin, barbiturati ili gospina trava/Hypericum perforatum).
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. 
Kad se razmatra primjena supstrata CYP2D6 u kombinaciji s gefitinibom, mora se uzeti u obzir prilagodba doze supstrata CYP2D6, osobito za lijekove s uskim terapijskim rasponom.