natgillin/translations-raw huggingface dataset:
An increased risk of ILD on gefitinib relative to chemotherapy was seen predominantly during the first 4 weeks of treatment (adjusted OR 3.8; 95% CI 1.9 to 7.7); thereafter the relative risk was lower (adjusted OR 2.5; 95% CI 1.1 to 5.8). 
Večje tveganje za IBP so med uporabo gefitiniba v primerjavi s kemoterapijo ugotovili predvsem v prvih 4 tednih zdravljenja (korigirano razmerje obetov 3,8; 95 % IZ od 1,9 do 7,7); pozneje se je relativno tveganje zmanjšalo (korigirano razmerje obetov 2,5; 95 % IZ od 1,1 do 5,8).
In the ISEL trial, the incidence of ILD-type events in the overall population was approximately 1% in both treatment arms. 
V preskušanju ISEL je incidenca učinkov tipa IBP v celotni populaciji, v obeh terapevtskih krakih znašala približno 1 %.
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). 
Analize populacijskih farmakokinetičnih podatkov onkoloških bolnikov niso pokazale povezanosti med napovedano najnižjo koncentracijo v stanju dinamičnega ravnovesja ter bolnikovo starostjo, telesno maso, spolom, etnično pripadnostjo ali očistkom kreatinina (nad 20 ml/min).
Other potential mechanisms of resistance that have been reported following treatment with EGFR signal blocking agents include: bypass signalling such as HER2 and MET gene amplification and PIK3CA mutations. 
Med drugimi možnimi mehanizmi odpornosti, opisanimi po zdravljenju z zaviralci signaliziranja EGFR, so obvodi signaliziranja, npr. amplifikacija genov HER2 in MET ter mutacije PIK3CA.
Studies in animals have shown reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja (glejte poglavje 5.3).
Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases (see section 5.2). 
Koncentracija v plazmi ni bila povečana pri bolnikih z zvišano aspartat transaminazo (AST), alkalno fosfatazo ali bilirubinom zaradi jetrnih metastaz (glejte poglavje 5.2).
In about 60% of cases, resistance is associated with a secondary T790M mutation for which T790M targeted EGFR TKIs may be considered as a next line treatment option. 
V približno 60 % primerov je odpornost povezana s sekundarno mutacijo T790M, pri kateri pridejo kot naslednja linija zdravljenja v poštev proti T790M usmerjeni zaviralci tirozin-kinaze EGFR.
The signs may include redness, pain, ulcers, blisters, and shedding of the skin. 
Med znaki so lahko pordelost, bolečine, razjede, mehurji in lupljenje kože.
Time to treatment failure ab 
Čas do odpovedi zdravljenja ab
For patients unable to tolerate treatment after a therapy interruption, gefitinib should be discontinued and an alternative treatment should be considered. 
Bolnikom, ki po prekinitvi zdravljenja zdravila ne prenesejo, je treba gefitinib ukiniti in razmisliti o drugačni terapiji.
The dispersion can also be administered through a naso-gastric or gastrostomy tube. 
Disperzijo je mogoče uporabiti po nazogastrični ali gastrostomijski sondi.
Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration. 
Po peroralni uporabi je absorbcija zmerno počasna in največja koncentracija gefitiniba v plazmi se praviloma pojavi od 3 do 7 ur po uporabi.
Five metabolites have been fully identified in excreta and 8 metabolites in plasma. 
V iztrebkih so povsem identificirali 5, v plazmi pa 8 presnovkov.
Driving and using machines If you feel weak whilst taking this medicine, take care driving or using tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Če se med jemanjem tega zdravila počutite šibki, morate biti glede upravljanja vozil ali strojev previdni.
Approximately 3% of patients stopped therapy due to an ADR. 
Približno 3 % bolnikov je zaradi neželenih učinkov prenehalo z zdravljenjem.
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). 
Pri bolnikih, ki imajo drisko in jo slabo prenašajo, ali imajo neželene učinke na koži, je stanje mogoče uspešno obvladati s kratko (do 14-dnevno) prekinitvijo zdravljenja, ki ji sledi ponovna uvedba odmerka 250 mg (glejte poglavje 4.8).
NC Not calculated for overall survival HR as the number of events is too few NR Not reached 
NI ni izračunano za razmerje ogroženosti pri skupnem preživetju, ker je število dogodkov premajhno.
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. 
V preskušanju INTEREST je bila incidenca učinkov tipa IBP 1,4 % (10 bolnikov) v skupini z gefitinibom in 1,1 % (8 bolnikov) v skupini z docetakselom.
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE02 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinkinaze Oznaka ATC: L01XE02
Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin 
• kožne reakcije, npr. aknam podoben izpuščaj, ki je včasih srbeč in ga spremlja suha in/ali razpokana koža
Proportion of tumour M+ that are M+ by ctDNA 
Delež tumorskih M+, ki so M+ po ctDNK
Administration of gefitinib once daily results in 2- to 8-fold accumulation, with steady state exposures achieved after 7 to 10 doses. 
Uporaba gefitiniba enkrat na dan povzroči od 2- do 8-kratno kopičenje; izpostavljenost v stanju dinamičnega ravnovesja je dosežena po 7 do 10 odmerkih.
If a tumour sample is not evaluable, then circulating tumour DNA (ctDNA) obtained from a blood (plasma) sample may be used. 
Če vzorca tumorja ni mogoče oceniti, se lahko uporabi tumorska DNK v obtoku (ctDNK - cirkulirajoča tumorska DNK), dobljena iz krvi (plazme).
The results of an in vitro phototoxicity study demonstrated that gefitinib may have phototoxicity potential. 
Rezultati študije fototoksičnosti in vitro so pokazali, da gefitinib morda ima fototoksičen potencial.
Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking IRESSA. 
• Ne jemljite antacidov (zdravil za zmanjšanje kisline v želodcu) 2 uri pred jemanjem zdravila
The levels of exposure to gefitinib achieved in both the extensive and the poor metaboliser groups were wide and overlapping but the mean exposure to gefitinib was 2-fold higher in the poor metaboliser group. 
Ravni izpostavljenosti gefitinibu, dosežene v skupini izrazitih in slabih metabolizatorjev so bile široke in so se prekrivale, a povprečna izpostavljenost gefitinibu je bila v skupini slabih metabolizatorjev 2-krat večja.
Interstitial lung disease (ILD) 
Intersticijska bolezen pljuč (IBP)
Gefitinib binds to serum albumin and alpha 1-acid glycoprotein. 
Gefitinib se veže na serumski albumin in alfa1-kisli glikoprotein.
If a diagnosis of ulcerative keratitis is confirmed, treatment with gefitinib should be interrupted, and if symptoms do not resolve, or if symptoms recur on reintroduction of gefitinib, permanent discontinuation should be considered. 
Če je potrjena diagnoza ulcerozni keratitis je potrebno prekiniti zdravljenje z gefitinibom in razmisliti o ukinitvi zdravljenja, v primeru, da simptomi ne prenehajo ali če se simptomi po ponovni uporabi gefitiniba ponovijo.
Data from non-clinical (in vitro) studies indicate that gefitinib has the potential to inhibit the cardiac action potential repolarisation process (e.g. QT interval). 
Podatki iz predkliničnih (in vitro) študij kažejo, da lahko gefitinib zavre akcijski potencial repolarizacijskega procesa srca (npr. interval QT).
If you forget to take IRESSA What to do if you forget to take a tablet depends on how long it is until your next dose. 
Če pozabite vzeti tableto, je ukrepanje odvisno od tega, koliko časa je še do naslednjega odmerka.
IRESSA is used to treat adults with non-small cell lung cancer. 
Zdravilo IRESSA se uporablja za zdravljenje odraslih z nedrobnoceličnim pljučnim rakom.
What IRESSA looks like and contents of the pack 
Izgled zdravila IRESSA in vsebina pakiranja
Children and adolescents IRESSA is not indicated in children and adolescents under 18 years. 
Otroci in mladostniki Uporaba zdravila IRESSA pri otrocih in mladostnikih, starih manj kot 18 let, ni priporočena.
The IFUM study was a single-arm, multicentre study conducted in Caucasian patients (n=106) with activating, sensitising EGFR mutation positive NSCLC to confirm that the activity of gefitinib is similar in Caucasian and Asian populations. 
Študija IFUM je bila multicentrična, z enim krakom in je bila izvedena na kavkazijskih bolnikih (n=106) z nedrobnoceličnim pljučnim rakom z aktivacijskimi, senzitirajočimi EGFR pozitivnimi mutacijami, s katero so potrdili, da je aktivnost gefitiniba podobna pri kavkazijski in azijski populaciji.
Gefitinib shows no enzyme induction effects in animal studies and no significant inhibition (in vitro) of any other cytochrome P450 enzyme. 
Gefitinib v študijah na živalih ne kaže učinkov na indukcijo encimov in (in vitro) ne zavira pomembno nobenega drugega encima citokroma P450.
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 
c Stratificirani log-rang test za celotno, sicer Coxov model sorazmernih ogroženosti d Azijska etnična pripadnost izključuje bolnike indijskega porekla in se nanaša na rasno poreklo skupine bolnikov, ne nujno na rojstni kraj.
In the overall population, no statistically significant difference between gefitinib and docetaxel (75 mg/m2) was observed for overall survival, progression free survival and objective response rates (see Table 5). 
V celotni populaciji ni bilo opaziti statistično značilne razlike med gefitinibom in docetakselom (75 mg/m2), kar zadeva skupno preživetje, preživetje brez napredovanja bolezni in objektivni delež odziva (glejte preglednico 5).
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. 
Bolnike z znaki in simptomi, ki kažejo na keratitis, kot so akutni simptomi ali poslabšanja: vnetje oči, solzenje, občutljivost na svetlobo, zamegljen vid, boleče in/ali rdeče oči, je treba takoj napotiti k oftalmologu.
Tablets are brown, round, biconvex, impressed with “IRESSA 250” on one side and plain on the other. 
Tablete so rjave, okrogle, bikonveksne z vtisnjeno oznako “IRESSA 250” na eni strani in brez oznak na drugi.
Most NSCLC tumours with sensitising EGFR kinase mutations eventually develop resistance to IRESSA treatment, with a median time to disease progression of 1 year. 
Večina tumorjev nedrobnoceličnega raka pljuč, ki imajo aktivacijske mutacije kinaze EGFR, sčasoma razvije odpornost na zdravilo IRESSA; mediani čas do napredovanja bolezni je 1 leto.
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). 
Neželeni učinki so v preglednici 1, kjer je mogoče, razvrščeni po kategorijah pogostnosti na podlagi incidence primerljivih poročil o neželenih učinkih v kumulativnem naboru podatkov kliničnih preskušanj III. faze ISEL, INTEREST in IPASS (2462 bolnikov, zdravljenih z zdravilom IRESSA).
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 
• zvišanje jetrnega encima, imenovanega alanin-aminotransferaza, na preiskavi krvi; če je raven tega encima previsoka, vam bo zdravnik morda naročil, da nehajte jemati zdravilo IRESSA
Do not take a double dose (two tablets at the same time) to make up for a forgotten dose. 
Ne vzemite dvojnega odmerka (dveh tablet hkrati), če ste pozabili vzeti prejšnji odmerek.
Gastrointestinal perforation has been reported in patients taking gefitinib. 
Opisani so bili posamezni primeri gastrointestinalne perforacije pri bolnikih, ki jemljejo gefitinib.
Sensitivity 
Senzitivnost
Three blisters are combined with an aluminium foil laminate over-wrap in a carton. 
Trije pretisni omoti so pakirani skupaj z zunanjim ovojem iz laminata aluminijske folije v škatli.
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. 
Dveletna študija kancerogenosti pri podganah je pokazala majhno, toda statistično značilno povečanje incidence hepatocelularnih adenomov pri podganjih samcih in samicah ter hemangiosarkomov mezenteričnih bezgavk pri podganjih samicah samo pri največjem odmerku (10 mg/kg/dan).
IRESSAcontains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor' (EGFR). 
Zdravilo IRESSA vsebuje zdravilno učinkovino gefitinib, ki blokira beljakovino, imenovano "receptor epidermalnega rastnega dejavnika" (EGFR).
Table 2 Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples 
Preglednica 2: Povzetek izhodiščnega stanja mutacije na tumorju in v vzorcih ctDNK pri vseh presejanih bolnikih, ki so imeli za oceno primerna oba vzorca
If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water. 
Če tableto težko pogoltnete, jo raztopite v pol kozarca negazirane vode (vode brez mehurčkov).
Only robust, reliable and sensitive test(s) with demonstrated utility for the determination of EGFR mutation status of tumours or ctDNA should be used to avoid false negative or false positive determinations (see section 5.1). 
Za določanje EGFR mutacije tumorjev ali ctDNK je treba uporabiti robustno, zanesljivo in občutljivo preiskavo/preiskave z dokazano uporabnostjo, da bi se izognili lažno negativnim ali lažno pozitivnim rezultatom (glejte poglavje 5.1).
In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86). 
V tisti študiji so za analizo mutacije EGFR uporabili ctDNK iz seruma, ne iz plazme, določitev pa so opravili s kompletom EGFR Mutation Test (DxS) (N = 86).
N Number of patients randomised 
N število randomiziranih bolnikov
Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine). 
• hemoragični cistitis (pekoč občutek med uriniranjem in pogosto, nujno siljenje na vodo s krvjo v urinu)
Primary endpoint Progression free survival (PFS) 
Primarni opazovani dogodek Preživetje brez napredovanja bolezni (PFS)
Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing. 
• Alergijska reakcija (občasno), zlasti če so med simptomi oteklost obraza, ustnic, jezika ali žrela, težko požiranje, koprivnica, izpuščaj in težave z dihanjem.
The randomised phase III INTEREST study was conducted in patients with locally advanced or metastatic NSCLC who had previously received platinum-based chemotherapy. 
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.
Mean absolute bioavailability is 59% in cancer patients. 
Povprečna absolutna biološka uporabnost pri onkoloških bolnikih je 59 %.
A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day. 
Zmanjšanje plodnosti pri podganah je bilo opaženo pri odmerku 20 mg/kg/dan.
Liver function test abnormalities (including increases in alanine aminotransferase, aspartate aminotransferase, bilirubin) have been observed, uncommonly presenting as hepatitis (see section 4.8). 
Opažene so bile nepravilnosti testov jetrnih funkcij (vključno z zvišanjem alanin-aminotransferaze, aspartat-aminotransferaze, bilirubina), občasno zabeležene kot hepatitis (glejte poglavje 4.8).
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). 
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).
Elevations in alanine aminotransferase, mainly mild to moderate 
Zvišanje alanin aminotransferaze, v glavnem blago do zmerno
Film-coated tablets (tablet). 
filmsko obložene tablete (tablete)
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. 
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.
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 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.
Such an increase might potentially be relevant for CYP2D6 substrates with narrow therapeutic index. 
Takšno povečanje bi lahko bilo pomembno pri substratih CYP2D6, ki imajo ozek terapevtski indeks.
Gefitinib has a mean steady-state volume of distribution of 1400 l indicating extensive distribution into tissue. 
Povprečni volumen porazdelitve gefitiniba v stanju dinamičnega ravnovesja je 1400 litrov, kar kaže na izdatno porazdelitev v tkiva.
Interstitial lung disease (1.3%), often severe (CTC grade 3-4). 
Intersticijska bolezen pljuč (1,3 %), pogosto huda (3.- 4. stopnja po CTC).
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, 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
NR vs 4.3 m 
s 4,3 m
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. 
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.
Overall 
Celotna
Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes). 
Med simptomi so lahko splošno slabo počutje z zlatenico (porumenelostjo kože in oči) ali brez nje.
If ILD is confirmed, IRESSA should be discontinued and the patient treated appropriately. 
Če je potrjena IBP, morate terapijo z zdravilom IRESSA končati in bolnika ustrezno zdraviti.
Asians 
Azijci
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]. 
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].
In poor metabolisers no measurable levels of O-desmethyl gefitinib were produced. 
Pri slabih metabolizatorjih niso ugotovili merljive koncentracije O-dezmetilgefitiniba.
N Objective response rates and 95% CI for difference between treatments 
Populacija N Objektivni delež odziva in 95 % IZ za razlike med zdravljenji
Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib. 
Bolniki z zmerno do hudo okvaro jeter (stopnja B ali C po Child-Pughu) imajo zaradi ciroze večjo koncentracijo gefitiniba v plazmi.
Gefitinib and metabolites of gefitinib accumulated in milk of lactating rats (see section 5.3). 
Gefitinib in njegovi presnovki se kopičijo v mleku doječih podgan (glejte poglavje 5.3).
CYP2D6 poor metabolisers 
Slabi metabolizatorji s CYP2D6
HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154 
c Interval zaupanja je v celoti pod mejo neinferiornosti 1,154.
At steady state, circulating plasma concentrations are typically maintained within a 2- to 3-fold range over the 24-hour dosing interval. 
V stanju dinamičnega ravnovesja se koncentracija v krožeči plazmi v 24-urnem odmernem intervalu praviloma ohrani znotraj 2- do 3-kratnega območja.
Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy (see section 4.3). 
Gefitinib je med obdobjem dojenja kontraindiciran, zato je treba med zdravljenjem z gefitinibom dojenje prekiniti (glejte poglavje 4.3).
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). 
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).
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. 
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.
If patients experience worsening of respiratory symptoms such as dyspnoea, cough and fever, IRESSA should be interrupted and the patient should be promptly investigated. 
Če se bolniku poslabšajo dihalni simptomi, npr. dispneja, kašelj in zvišana telesna temperatura, morate zdravljenje z zdravilom IRESSA prekiniti in bolnika takoj preiskati.
Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever. 
• Resno težko dihanje ali nenadno poslabšanje težkega dihanja, lahko s spremljajočim kašljem ali zvišano telesno temperaturo.
IRESSA is a round brown tablet marked with ‘IRESSA 250' on one side and plain on the other. 
Zdravilo IRESSA so okrogle rjave tablete z oznako ‘IRESSA 250‘ na eni strani in brez oznake na drugi.
In vitro data indicate that gefitinib is a substrate for the membrane transport protein P-gp. 
Podatki in vitro kažejo, da je gefitinib substrat membranske transportne beljakovine Pgp.