FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver function test abnormalities (including increases in alanine aminotransferase, aspartate aminotransferase, bilirubin) have been observed, uncommonly presenting as hepatitis (see section 4.8).
Croatian: 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).
English: IRESSA is a round brown tablet marked with ‘IRESSA 250' on one side and plain on the other.
Croatian: IRESSA tableta je okrugla i smeđa, s utisnutom oznakom "IRESSA 250" na jednoj i bez oznaka na drugoj strani.
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.
Croatian: Podaci iz kliničkih ispitivanja faze II, u kojima su se istodobno primjenjivali gefitinib i vinorelbin, ukazuju da gefitinib može pojačati neutropenijski učinak vinorelbina.
English: When administered to the rat throughout gestation and parturition, there was a reduction in pup survival at a dose of 20 mg/kg/day.
Croatian: Prilikom primjene u štakora tijekom gestacije i okota, došlo je do smanjenog preživljenja mladunčadi pri dozi od 20 mg/kg/dan.
English: Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration.
Croatian: Nakon peroralne primjene, apsorpcija gefitiniba je umjereno spora te se vršne koncentracije gefitiniba u plazmi u pravilu postižu 3 do 7 sati nakon primjene.
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib.
Croatian: Bolesnici s umjerenim do teškim oštećenjem jetrene funkcije (Child-Pugh B ili C) uslijed ciroze imaju povišene koncentracije gefitiniba u plazmi.
English: Concomitant administration with potent inhibitors of CYP3A4 activity (e.g. ketoconazole, posaconazole, voriconazole, protease inhibitors, clarithromycin, telithromycin) may increase gefitinib plasma concentrations.
Croatian: Istodobna primjena sa snažnim inhibitorima aktivnosti CYP3A4 (npr. ketokonazol, posakonazol, vorikonazol, inhibitori proteaze, klaritromicin, telitromicin) može povećati koncentracije gefitiniba u plazmi.
English: Hepatotoxicity and liver impairment
Croatian: Hepatotoksičnost i oštećenje jetre
English: However, in the rabbit, there were reduced foetal weights at 20 mg/kg/day and above.
Croatian: Međutim, u zečeva je došlo do smanjenja težine fetusa pri dozama od 20 mg/kg/dan i višim.
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.
Croatian: 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.
English: Three blisters are combined with an aluminium foil laminate over-wrap in a carton.
Croatian: Tri blistera su pakirana u zajednički zaštitni omot od slojevite aluminijske folije, u kutiji.
English: The frequency of adverse drug reactions relating to abnormal laboratory values is based on patients with a change from baseline of 2 or more CTC grades in the relevant laboratory parameters.
Croatian: 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.
English: It was shown that following daily administration of 250 mg gefitinib, time to steady-state, total plasma clearance (CmaxSS) and steady-state exposure (AUC24SS) were similar for the groups with normal and moderately impaired hepatic function.
Croatian: 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.
English: Anorexia mild or moderate (CTC grade 1 or 2)
Croatian: Anoreksija blaga ili umjerena (CTC stupanj 1 ili 2)
English: Interstitial lung disease (1.3%), often severe (CTC grade 3-4).
Croatian: Intersticijska bolest pluća (1,3%), često teška (CTC stupanj 3-4).
English: Skin reactions, mainly a mild or moderate (CTC grade 1 or 2) pustular rash, sometimes itchy with dry skin, including skin fissures, on an erythematous base
Croatian: 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
English: Impaired liver function due to cirrhosis has been shown to lead to increased plasma concentrations of gefitinib (see section 5.2).
Croatian: Pokazalo se da oštećena funkcija jetre uslijed ciroze dovodi do povišenja koncentracije gefitiniba u plazmi (vidjeti dio 5.2).
English: One ILD-type event was fatal, and this occurred in a patient receiving placebo.
Croatian: Jedan slučaj tipa ILD-a imao je smrtni ishod, a radilo se o bolesniku koji je primao placebo.
English: The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, povidone (K29-32) (E1201), sodium laurilsulfate, magnesium stearate, hypromellose (E464), macrogol 300, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
Croatian: • 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).
English: In a post-marketing surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving gefitinib was 5.8%.
Croatian: 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.
English: The majority of ILD-type events reported was from patients of Asian ethnicity and the ILD incidence among patients of Asian ethnicity receiving gefitinib therapy and placebo was approximately 3% and 4% respectively.
Croatian: 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%.
English: Such an increase might potentially be relevant for CYP2D6 substrates with narrow therapeutic index.
Croatian: Takav porast se može pokazati značajnim za supstrate CYP2D6 s uskim terapijskim indeksom.
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.
Croatian: 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.
English: Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
Croatian: • dehidracija (često) uzrokovana dugotrajnim ili teškim proljevom, povraćanje, mučnina ili gubitak apetita.
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.
Croatian: Djelatne tvari čija se koncentracija u plazmi može promijeniti djelovanjem gefitiniba In vitro studije su pokazale da gefitinib ima ograničen potencijal za inhibiciju CYP2D6.
English: During treatment with gefitinib, asthenia has been reported.
Croatian: Tijekom liječenja gefitinibom zabilježena je astenija.
English: In a phase I open-label study of single dose gefitinib 250 mg in patients with mild, moderate or severe hepatic impairment due to cirrhosis (according to Child-Pugh classification), there was an increase in exposure in all groups compared with healthy controls.
Croatian: 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.
English: A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day.
Croatian: Opaženo je smanjenje plodnosti ženki štakora pri dozi od 20 mg/kg/dan.
English: In vitro data indicate that CYP3A4 and CYP2D6 are the major P450 isozyme involved in the oxidative metabolism of gefitinib.
Croatian: Podaci dobiveni in vitro ukazuju da su CYP3A4 i CYP2D6 glavni izoenzimi citokroma P450 uključeni u oksidativni metabolizam gefitiniba.
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.
Croatian: 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.
English: Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1)
Croatian: Konjunktivitis, blefaritis i suhoća oka*, uglavnom blagi (CTC stupanj 1)
English: 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.
Croatian: 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.
English: Therefore, concomitant administration of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum) may reduce efficacy of the treatment and should be avoided (see section 4.5).
Croatian: 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).
English: Primary endpoint overall survival abc
Croatian: Primarna mjera ishoda: ukupno preživljenje abc
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.
Croatian: 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.
English: HR NC
Croatian: HR NI
English: The recommended posology of IRESSA is one 250 mg tablet once a day.
Croatian: Preporučena doza lijeka IRESSA je jedna tableta od 250 mg jednom na dan.
English: Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort/ Hypericum perforatum) should be avoided.
Croatian: Treba izbjegavati istodobnu primjenu lijekova koji induciraju CYP3A4 (npr. fenitoin, karbamazepin, rifampicin, barbiturati ili gospina trava/Hypericum perforatum).
English: When the use of CYP2D6 substrates are considered in combination with gefitinib, a dose modification of the CYP2D6 substrate should be considered especially for products with a narrow therapeutic window.
Croatian: 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.
English: In poor metabolisers no measurable levels of O-desmethyl gefitinib were produced.
Croatian: U sporih metabolizatora nisu nastajale mjerljive razine O-demetil gefitiniba.
English: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium Povidone (K29-32) (E1201) Sodium laurilsulfate Magnesium stearate
Croatian: Jezgra tablete laktoza hidrat celuloza, mikrokristalična (E460) karmelozanatrij, umrežena povidon (K29-32) (E1201) natrijev laurilsulfat magnezijev stearat
English: 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.
Croatian: Razine izloženosti gefitinibu postignute i u brzih i u sporih metabolizatora bile su široke i preklapale su se, ali je prosječna izloženost gefitinibu bila dvostruko veća u skupini sporih metabolizatora.
English: At initiation of treatment with a CYP3A4 inhibitor, patients should be closely monitored for gefitinib adverse reactions (see section 4.5).
Croatian: Na početku liječenja inhibitorom CYP3A4, bolesnike treba pomno nadzirati zbog mogućih nuspojava gefitiniba (vidjeti dio 4.5).
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).
Croatian: Nema posebnih preporuka za prilagodbu doze u bolesnika koji su po genotipu spori metabolizatori izoenzima CYP2D6, ali te bolesnike treba pomno nadzirati zbog mogućih štetnih događaja (vidjeti dio 5.2).
English: Do not use this medicine after the expiry date which is stated on the carton, blister and overwrap foil after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru i zaštitnoj foliji iza „Rok valjanosti“ ili kratice EXP.
English: Table 7 Summary of multivariate logistic regression analysis to identify factors that independently predicted for the presence of EGFR mutations in 786 Caucasian patients*
Croatian: Tablica 7 Sažetak multivarijatne logističke regresijske analize za utvrđivanje čimbenika koji su neovisno pretkazali prisutnost mutacije EGFR u 786 bolesnika bijele rase* Čimbenici koji su pretkazali prisutnost mutacije EGFR
English: Pre-treatment with rifampicin (a potent CYP3A4 inducer) in healthy volunteers reduced mean gefitinib AUC by 83% (see section 4.4).
Croatian: Prethodno liječenje rifampicinom (snažan induktor CYP3A4) u zdravih je dobrovoljaca smanjilo prosječni AUC gefitiniba za 83% (vidjeti dio 4.4).
English: If it is less than 12 hours until your next dose: skip the missed tablet.
Croatian: • Ako je do sljedeće doze ostalo manje od 12 sati: preskočite propuštenu tabletu.
English: The randomised phase III ISEL study was conducted in patients with advanced NSCLC who had received 1 or 2 prior chemotherapy regimens and were refractory or intolerant to their most recent regimen.
Croatian: Randomizirano kliničko ispitivanje faze III (ISEL) provedeno je u bolesnika s uznapredovalim NSCLC-om koji su prethodno primili 1 ili 2 režima kemoterapije te nisu odgovorili na posljednju kemoterapiju ili je nisu podnosili.
English: Antacids if taken regularly close in time to administration of gefitinib may have a similar effect (see sections 4.5 and 5.2).
Croatian: Antacidi mogu imati sličan učinak ako se uzimaju redovito u kratkom vremenskom razmaku u odnosu na primjenu gefitiniba (vidjeti dijelove 4.5 i 5.2).
English: 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.
Croatian: Multicentrično ispitivanje s jednom skupinom, IFUM, provedeno je na ispitanicima bijele rase (n=106) s rakom pluća nemalih stanica (NSCLC) s aktivirajućom senzibilizirajućom mutacijom EGFR s ciljem potvrde da je aktivnost gefitiniba jednaka u populaciji bijelaca i azijata.
English: Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Croatian: Ovojnica tablete hipromeloza (E464) makrogol 300 titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: There were no compound-induced malformations in either species.
Croatian: U drugih vrsta nisu zabilježene malformacije uzrokovane spojem.
English: The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6.
Croatian: Metabolizam gefitiniba se odvija putem izoenzima CYP3A4 citokroma P450 (predominantno) te putem izoenzima CYP2D6.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar iste kategorije učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: Interstitial lung disease (ILD) which may be acute in onset, has been observed in 1.3% of patients receiving gefitinib, and some cases have been fatal (see section 4.8).
Croatian: Intersticijska bolest pluća (interstitial lung disease, ILD), koja može nastupiti u akutnom obliku, zabilježena je u 1,3% bolesnika liječenih gefitinibom, a u nekim je slučajevima imala smrtni ishod (vidjeti dio 4.8).
English: IRESSAcontains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor' (EGFR).
Croatian: IRESSA sadrži djelatnu tvar gefitinib koja blokira protein zvan „receptor epidermalnog faktora rasta“ (EGFR, prema engl. epidermal growthfactor receptor).
English: This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija u jednoj tableti, što znači da gotovo ne sadrži natrij.
English: Risk of mortality among patients who developed ILD on IRESSA or chemotherapy was higher in patients with the following risk factors: smoking, CT scan evidence of reduced normal lung (≤ 50%), pre-existing ILD, older age (≥ 65 years old), and extensive areas adherent to pleura (≥ 50%).
Croatian: Rizik smrtnosti bolesnika u kojih se razvio ILD tijekom liječenja IRESSA tabletama ili kemoterapijom bio je veći u bolesnika sa sljedećim čimbenicima rizika: pušenje, CT-om dokazano smanjenje normalnog plućnog tkiva (≤ 50%), otprije postojeći ILD-om, starija dob (≥ 65 godina) te opsežne pleuralne priraslice (≥ 50%).
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.
Croatian: Lijekovi koji uzrokuju značajno trajno povišenje želučanog pH, kao što su inhibitori protonske pumpe i antagonisti H2-receptora, mogu smanjiti bioraspoloživost i plazmatske koncentracije gefitiniba te tako umanjiti njegovu djelotvornost.
English: For patients unable to tolerate treatment after a therapy interruption, gefitinib should be discontinued and an alternative treatment should be considered.
Croatian: U bolesnika koji ni nakon ovog kratkotrajnog prekida ne podnose liječenje, treba ukinuti primjenu gefitiniba i razmotriti druge opcije liječenja.
English: N patients
Croatian: N bolesnika
English: At steady state, circulating plasma concentrations are typically maintained within a 2- to 3-fold range over the 24-hour dosing interval.
Croatian: U stanju dinamičke ravnoteže, koncentracije koje cirkuliraju u plazmi su tijekom 24-satnog intervala doziranja u pravilu održane unutar raspona od dvostruke do trostruke razine normalnih vrijednosti.
English: Table 2 Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples
Croatian: Tablica 2 Sažetak početnog statusa mutacije u uzorcima tumora i ctDNK kod svih bolesnika koji su pristupili probiru i kod kojih su se mogla ocijeniti oba uzorka.
English: Adverse reactions by system organ class and frequency Metabolism and nutrition disorders
Croatian: Nuspojave prema klasifikaciji organskih sustava i učestalosti pojavljivanja Poremećaji metabolizma i prehrane
English: In individual patients with CYP2D6 poor metaboliser genotype, treatment with a potent CYP3A4 inhibitor might lead to increased plasma levels of gefitinib.
Croatian: U pojedinih bolesnika koji su po genotipu spori metabolizatori CYP2D6, liječenje snažnim inhibitorom CYP3A4 može dovesti do porasta razine gefitiniba u plazmi.
English: Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ≥ 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).
Croatian: Istodobna primjena gefitiniba s ranitidinom u dozi koja uzrokuje trajno povišenje želučanog pH ≥5, u zdravih je dobrovoljaca uzrokovala smanjenje prosječnog AUC-a gefitiniba za 47% (vidjeti dijelove 4.4 i 5.2).
English: The increase might be higher in individual patients with CYP2D6 poor metaboliser genotype.
Croatian: Povećanje može biti veće u pojedinih bolesnika koji su po genotipu spori metabolizatori CYP2D6.
English: The randomised phase III INTEREST study was conducted in patients with locally advanced or metastatic NSCLC who had previously received platinum-based chemotherapy.
Croatian: Randomizirano kliničko ispitivanje faze III (INTEREST) provedena je u bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća ne-malih stanica koji su prethodno liječeni kemoterapijom temeljenom na platini.
English: The increase may be clinically relevant since adverse reactions are related to dose and exposure.
Croatian: Povećanje može biti klinički značajano, jer su nuspojave povezane s dozom i izloženošću.
English: One ILD-type event was fatal, and this occurred in a patient receiving gefitinib.
Croatian: Jedan slučaj tipa ILD-a imao je smrtni ishod, a radilo se o bolesniku koji je primao gefitinib.
English: No clinically relevant activity has been shown in patients with known EGFR mutation-negative tumours.
Croatian: Nije pokazano klinički značajno djelovanje u bolesnika s tumorom koji je negativan na mutaciju EGFR-a.
English: IRESSA contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free.'
Croatian: Natrij IRESSA sadrži manje od 1 mmol (23 mg) natrija u jednoj tableti, što znači da gotovo ne sadrži natrij.
English: Pack size of 30 film-coated tablets.
Croatian: Veličina pakiranja: 30 filmom obloženih tableta.
English: Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
Croatian: • hemoragijski cistitis (osjećaj pečenja prilikom mokrenja te učestala, hitna potreba za mokrenjem uz prisutnost krvi u mokraći).
English: Discontinuation should be considered if changes are severe.
Croatian: Ako su promjene teške, treba razmotriti prekid liječenja.
English: Elevations in total bilirubin, mainly mild to moderate
Croatian: Povišenje vrijednosti ukupnog bilirubina, većinom blago do umjereno