natgillin/translations-raw huggingface dataset:
In poor metabolisers no measurable levels of O-desmethyl gefitinib were produced. 
U sporih metabolizatora nisu nastajale mjerljive razine O-demetil gefitiniba.
Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium Povidone (K29-32) (E1201) Sodium laurilsulfate Magnesium stearate 
Jezgra tablete laktoza hidrat celuloza, mikrokristalična (E460) karmelozanatrij, umrežena povidon (K29-32) (E1201) natrijev laurilsulfat magnezijev stearat
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. 
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.
At initiation of treatment with a CYP3A4 inhibitor, patients should be closely monitored for gefitinib adverse reactions (see section 4.5). 
Na početku liječenja inhibitorom CYP3A4, bolesnike treba pomno nadzirati zbog mogućih nuspojava gefitiniba (vidjeti dio 4.5).
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). 
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).
Do not use this medicine after the expiry date which is stated on the carton, blister and overwrap foil after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru i zaštitnoj foliji iza „Rok valjanosti“ ili kratice EXP.
Table 7 Summary of multivariate logistic regression analysis to identify factors that independently predicted for the presence of EGFR mutations in 786 Caucasian patients* 
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
Pre-treatment with rifampicin (a potent CYP3A4 inducer) in healthy volunteers reduced mean gefitinib AUC by 83% (see section 4.4). 
Prethodno liječenje rifampicinom (snažan induktor CYP3A4) u zdravih je dobrovoljaca smanjilo prosječni AUC gefitiniba za 83% (vidjeti dio 4.4).
If it is less than 12 hours until your next dose: skip the missed tablet. 
• Ako je do sljedeće doze ostalo manje od 12 sati: preskočite propuštenu tabletu.
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. 
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.
Antacids if taken regularly close in time to administration of gefitinib may have a similar effect (see sections 4.5 and 5.2). 
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).
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. 
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.
Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172) 
Ovojnica tablete hipromeloza (E464) makrogol 300 titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
There were no compound-induced malformations in either species. 
U drugih vrsta nisu zabilježene malformacije uzrokovane spojem.
The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6. 
Metabolizam gefitiniba se odvija putem izoenzima CYP3A4 citokroma P450 (predominantno) te putem izoenzima CYP2D6.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
Unutar iste kategorije učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
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). 
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).
IRESSAcontains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor' (EGFR). 
IRESSA sadrži djelatnu tvar gefitinib koja blokira protein zvan „receptor epidermalnog faktora rasta“ (EGFR, prema engl. epidermal growthfactor receptor).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija u jednoj tableti, što znači da gotovo ne sadrži natrij.
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%). 
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%).
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. 
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.
For patients unable to tolerate treatment after a therapy interruption, gefitinib should be discontinued and an alternative treatment should be considered. 
U bolesnika koji ni nakon ovog kratkotrajnog prekida ne podnose liječenje, treba ukinuti primjenu gefitiniba i razmotriti druge opcije liječenja.
N patients 
N bolesnika
At steady state, circulating plasma concentrations are typically maintained within a 2- to 3-fold range over the 24-hour dosing interval. 
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.
Table 2 Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples 
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.
Adverse reactions by system organ class and frequency Metabolism and nutrition disorders 
Nuspojave prema klasifikaciji organskih sustava i učestalosti pojavljivanja Poremećaji metabolizma i prehrane
In individual patients with CYP2D6 poor metaboliser genotype, treatment with a potent CYP3A4 inhibitor might lead to increased plasma levels of gefitinib. 
U pojedinih bolesnika koji su po genotipu spori metabolizatori CYP2D6, liječenje snažnim inhibitorom CYP3A4 može dovesti do porasta razine gefitiniba u plazmi.
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). 
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).
The increase might be higher in individual patients with CYP2D6 poor metaboliser genotype. 
Povećanje može biti veće u pojedinih bolesnika koji su po genotipu spori metabolizatori CYP2D6.
The randomised phase III INTEREST study was conducted in patients with locally advanced or metastatic NSCLC who had previously received platinum-based chemotherapy. 
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.
The increase may be clinically relevant since adverse reactions are related to dose and exposure. 
Povećanje može biti klinički značajano, jer su nuspojave povezane s dozom i izloženošću.
One ILD-type event was fatal, and this occurred in a patient receiving gefitinib. 
Jedan slučaj tipa ILD-a imao je smrtni ishod, a radilo se o bolesniku koji je primao gefitinib.
No clinically relevant activity has been shown in patients with known EGFR mutation-negative tumours. 
Nije pokazano klinički značajno djelovanje u bolesnika s tumorom koji je negativan na mutaciju EGFR-a.
IRESSA contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free.' 
Natrij IRESSA sadrži manje od 1 mmol (23 mg) natrija u jednoj tableti, što znači da gotovo ne sadrži natrij.
Pack size of 30 film-coated tablets. 
Veličina pakiranja: 30 filmom obloženih tableta.
Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine). 
• hemoragijski cistitis (osjećaj pečenja prilikom mokrenja te učestala, hitna potreba za mokrenjem uz prisutnost krvi u mokraći).
Discontinuation should be considered if changes are severe. 
Ako su promjene teške, treba razmotriti prekid liječenja.
Elevations in total bilirubin, mainly mild to moderate 
Povišenje vrijednosti ukupnog bilirubina, većinom blago do umjereno
Each tablet contains 250 mg gefitinib. 
Jedna tableta sadržava 250 mg gefitiniba.
This increase in exposure may be of clinical relevance since adverse experiences are related to dose and exposure to gefitinib. 
Taj porast izloženosti može biti od kliničkog značaja, jer su nuspojave povezane s dozom i izloženošću gefitinibu.
Interstitial lung disease (ILD) has occurred in 1.3% of patients, often severe (CTC grade 3-4). 
Intersticijska bolest pluća (ILD) se javila u 1,3% bolesnika i često je bila teška (CTC stupanj 3-4).
In a clinical trial in patients, gefitinib was co-administered with metoprolol (a CYP2D6 substrate). 
U jednom je kliničkom ispitivanju gefitinib primijenjen bolesnicima zajedno s metoprololom (supstratom CYP2D6).
Ever smoker 
Nekad pušili
Elevations in alanine aminotransferase, mainly mild to moderate 
Povišenje vrijednosti alanin aminotransferaze, većinom blago do umjereno
Women of childbearing potential 
Žene u generativnoj dobi
In the IPASS trial, IRESSA demonstrated superior PFS, ORR, QoL and symptom relief with no significant difference in overall survival compared to carboplatin/paclitaxel in previously untreated patients, with locally advanced or metastatic NSCLC, whose tumours harboured activating mutations of the EGFR tyrosine kinase. 
U ispitivanju IPASS, IRESSA se pokazala boljom što se tiče preživljenja bez progresije bolesti, stope objektivnog odgovora, kvalitete života i olakšanja simptoma, dok nije bilo značajne razlike u ukupnom preživljenju u usporedbi s liječenjem karboplatinom/paklitakselom u prethodno neliječenih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica, koji imaju tumor s aktivirajućom mutacijom tirozin kinaze EGFR-a.
Substances that inhibit CYP3A4 may decrease the clearance of gefitinib. 
Tvari koje inhibiraju CYP3A4 mogu smanjiti klirens gefitiniba.
IRESSA contains lactose. 
IRESSA sadrži laktozu.
Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers. 
Prethodno liječenje itrakonazolom (snažan inhibitor CYP3A4) u zdravih je dobrovoljaca izazvalo porast prosječnog AUC-a gefitiniba za 80%.
Pretreated patients 
Prethodno liječeni bolesnici
Further precautions for use 
Dodatne mjere opreza pri primjeni
Female 
Žene
IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 
IRESSA je indicirana kao monoterapija za liječenje odraslih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća ne-malih stanica (non-small cell lung cancer, NSCLC) s aktivirajućim mutacijama tirozin kinaze receptora epidermalnog faktora rasta (epidermal growth factor receptor tyrosine kinase, EGFR-TK) (vidjeti dio 4.4).
Elevations in aspartate aminotransferase, mainly mild to moderate 
Povišenje vrijednosti aspartat aminotransferaze, većinom blago do umjereno
a Values presented are for IRESSA versus placebo. 
Prikazane su vrijednosti za lijek IRESSA u usporedbi s placebom.
If concomitant treatment with a potent CYP2D6 inhibitor is initiated, the patient should be closely monitored for adverse reactions. 
Ako se uvodi istodobno liječenje snažnim inhibitorom CYP2D6, bolesnika treba pomno nadzirati zbog mogućih nuspojava.
CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations. 
Induktori izoenzima CYP3A4 mogu pojačati metabolizam gefitiniba i sniziti koncentracije gefitiniba u plazmi.
IRESSA contains lactose 
IRESSA sadrži laktozu
In EGFR mutation-positive patients, significantly more IRESSA-treated patients experienced an improvement in quality of life and lung cancer symptoms vs. carboplatin/paclitaxel (see Table 4). 
Među bolesnicima pozitivnima na mutaciju EGFR-a, poboljšanje kvalitete života i simptoma raka pluća zabilježeno je u značajno većem broju onih liječenih lijekom IRESSA u odnosu na one liječene karboplatinom/paklitakselom (vidjeti Tablicu 4).
Numbers in square brackets are 95% confidence intervals for HR N Number of patients randomised. 
Brojevi u uglatim zagradama predstavljaju 95%-tni interval pouzdanosti za omjer rizika (HR).
Diarrhoea, mainly mild or moderate (CTC grade 1 or 2) Vomiting, mainly mild or moderate (CTC grade 1 or 2) Nausea, mainly mild (CTC grade 1) 
Povraćanje, većinom blago ili umjereno (CTC stupanj 1 ili 2) Mučnina, većinom blaga (CTC stupanj 1) Stomatitis, pretežno blag (CTC stupanj 1)
Bleeding (such as nose bleed or blood in your urine) Protein in your urine (shown in a urine test) 
• krvarenje (poput krvarenja iz nosa ili krvi u mokraći)
Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib. 
Tvari koje uzrokuju značajno trajno povišenje želučanog pH mogu smanjiti plazmatske koncentracije gefitiniba te tako umanjiti djelotvornost gefitiniba.
Haemorrhage, such as epistaxis and haematuria 
Krvarenje, kao što su epistaksa i hematurija
Without crushing it, the tablet should be dropped in half a glass of drinking water. 
Tabletu treba ubaciti cijelu, bez drobljenja, u pola čaše pitke vode.
Table 4 Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population 
Tablica 4 Ishodi kvalitete života za gefitinib u usporedbi s karboplatinom/paklitakselom u ispitivanju IPASS
Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration 
Hepatocelularna nekroza i eozinofilna sinusoidalna infiltracija makrofagima.
IRESSA 250 mg tablets gefitinib 
IRESSA 250 mg tablete gefitinib
Inflammation of the liver. 
• upala jetre.
In vitro data indicate that gefitinib is a substrate for the membrane transport protein P-gp. 
Podaci dobiveni in vitro ukazuju da je gefitinib supstrat za membranski transportni protein
Adenocarcinoma 
Adenokarcinom
Primary endpoint Progression free survival (PFS) 
Preživljenje bez progresije bolesti (PFS)
Patients should be advised to seek medical advice immediately if they experience severe or persistent diarrhoea, nausea, vomiting or anorexia as these may indirectly lead to dehydration. 
• teški ili perzistirajući proljev, mučninu, povraćanje ili anoreksiju jer to može neizravno dovesti do dehidracije.
Haemorrhagic cystitis 
Hemoragijski cistitis
How to store IRESSA 
Kako čuvati lijek IRESSA
Weakness 
• slabost
Some lung problems may get worse during treatment with IRESSA. 
Neke tegobe s plućima mogu se pogoršati tijekom liječenja lijekom IRESSA. ako ste nekad imali tegoba s jetrom.
How to take IRESSA 
Kako uzimati lijek IRESSA
a Values presented are for IRESSA versus docetaxel. 
Prikazane su vrijednosti za lijek IRESSA u usporedbi s docetakselom.
HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154 
Brojevi u uglatim zagradama predstavljaju 96%-tni interval pouzdanosti za omjer rizika za ukupno preživljenje u ukupnoj populaciji, odnosno 95%-tni interval pouzdanosti za omjer rizika c Interval pouzdanosti je u cijelosti ispod granice neinferiornosti od 1,154 N Broj randomiziranih bolesnika.
Overall survival a,b 
Ukupno preživljenje ab
Non-adenocarcinoma 
Neadenokarcinom
Red and sore eyelids 
• crveni i bolni kapci
Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population 
Tablica 6 Ishodi djelotvornosti za gefitinib u usporedbi s placebom u ispitivanju ISEL Populacija
Very common: side effects (may affect more than 1 in 10 people) Diarrhoea 
Vrlo česte: mogu se javiti u više od 1 na 10 osoba
In situations of concomitant treatment with potent inhibitors of CYP3A4 the patient should be closely monitored for gefitinib adverse reactions. 
U slučaju istodobnog liječenja snažnim inhibitorima CYP3A4 bolesnika treba pomno nadzirati zbog mogućih nuspojava gefitiniba.
Gastrointestinal perforation has been reported in patients taking gefitinib. 
U bolesnika koji su uzimali gefitinib zabilježene su perforacije u gastrointestinalnom traktu.
EGFR mutation status and clinical characteristics Clinical characteristics of never smoker, adenocarcinoma histology, and female gender have been shown to be independent predictors of positive EGFR mutation status in a multivariate analysis of 786 Caucasian patients from gefitinib studies* (see Table 7). 
U multivarijatnoj analizi 786 bolesnika bijele rase iz ispitivanja s gefitinibom*, pokazalo se da su klinička obilježja da osoba nikada nije pušila, da ima histologiju adenokarcinoma i da je ženskog spola neovisni pretkazatelji pozitivnog statusa mutacije EGFR (vidjeti Tablicu 7).
Nail problems 
• problemi s noktima
Unadjusted analysis PP population for clinical factors ITT population for biomarker factors 
Neprilagođena analiza Populacija liječena prema protokolu (PP) za kliničke čimbenike
IRESSA 250 mg film-coated tablets gefitinib 
IRESSA 250 mg filmom obložene tablete gefitinib
Progression free survival ab 
Preživljenje bez progresije bolesti ab
IRESSA 250 mg film-coated tablets 
IRESSA 250 mg filmom obložene tablete
INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4). 
U nekih bolesnika koji su istodobno uzimali varfarin prijavljene su povišene INR vrijednosti i/ili krvarenja (vidjeti dio 4.4).
Table 5 Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study 
Tablica 5 Ishodi djelotvornosti za gefitinib u usporedbi s docetakselom u INTEREST ispitivanju Populacija
EGFR Mutation+ 
+ mutacija EGFR
Corneal epithelia atrophy and corneal translucencies Renal papillary necrosis 
Atrofija epitela rožnice i prozirnost rožnice Bubrežna papilarna nekroza
Table 3 Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population 
Tablica 3 Ishodi djelotvornosti za gefitinib u usporedbi s karboplatinom/paklitakselom u IPASS ispitivanju
N FACT-L QoL improvement rate 
N Stopa poboljšanja kvalitete života prema FACT-L
Trial outcome index results were supportive of FACT-L and LCS results 
Indeksirani ishodi ispitivanja podržali su FACT-L i LCS rezultate a Prikazane su vrijednosti za lijek IRESSA u usporedbi s karboplatinom/paklitakselom.
International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5). 
U nekih bolesnika koji su zajedno s gefitinibom uzimali varfarin zabilježen je porast međunarodnog normaliziranog omjera (international normalised ratio, INR) i/ili epizode krvarenja (vidjeti dio 4.5).
• Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA Increase of creatinine levels in a blood test (related to kidney function) Cystitis (burning sensations during urination and frequent, urgent need to urinate) 
• porast vrijednosti bilirubina i drugog jetrenog enzima koji se zove aspartat aminotransferaza u nalazima krvnih pretraga; ako su vrijednosti previsoke, liječnik Vam može reći da prestanete uzimati lijek IRESSA
Active substances that may reduce gefitinib plasma concentrations Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib. 
Tvari koje su induktori aktivnosti CYP3A4 mogu pojačati metabolizam i sniziti koncentracije gefitiniba u plazmi te time umanjiti djelotvornost gefitiniba.
However, in phase I clinical trials, a limited number of patients were treated with daily doses of up to 1000 mg. An increase of frequency and severity of some adverse reactions was observed, mainly diarrhoea and skin rash. 
Međutim, u kliničkom ispitivanju faze I ograničen broj bolesnika liječen je dnevnim dozama do 1000 mg.
Primary endpoint overall survival ab 
Primarna mjera ishoda ukupno preživljenje ab
An average 3.1-fold increase in exposure to gefitinib in patients with moderate and severe hepatic impairment was observed. 
U bolesnika s umjerenim i teškim oštećenjem jetre opažen je porast izloženosti gefitinibu za prosječno 3,1 puta.
Factors that predicted for presence of EGFR mutation p-value 
p-vrijednost Izgledi za mutaciju EGFR
In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86). 
U tom se ispitivanju za analizu mutacije EGFR-a koristila ctDNK iz seruma, a ne iz plazme, a provedena je uz pomoć kompleta testnih reagensa EGFR
The formation of O-desmethyl gefitinib has been shown, in vitro, to be via CYP2D6. 
Nastajanje O-demetil gefitiniba se odvija putem CYP2D6, kako je pokazano in vitro.
6.1List of excipients 
6.1 Popis pomoćnih tvari
Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia 
Dehidracija kao posljedica proljeva, mučnina, povraćanje ili anoreksija Suha usta*, pretežno blaga (CTC stupanj
Active substances that may increase gefitinib plasma concentrations In vitro studies have shown that gefitinib is a substrate of p-glycoprotein (Pgp). 
In vitro ispitivanja su pokazala da je gefitinib supstrat P-glikoproteina (Pgp).
Asthenia, predominantly mild (CTC grade 1) 
Astenija, pretežno blaga (CTC stupanj 1)
AstraZeneca AB SE-151 85 
AstraZeneca AB SE-151 85 Södertälje Švedska
Proportion of tumour M- that are Mby ctDNA) 
Udio M- tumora kod kojih je ctDNK bio M
HR 0.82 [0.70 to 0.96] 18.9 m vs. 17.2 m 
HR 0,82 [0,70 do 0,96] 18.9 m vs 17,2 m a Prikazane su vrijednosti za lijek IRESSA u usporedbi s karboplatinom/paklitakselom.
42.9 v. 20.0 EGFR Mutation+ 
6.2 v. 7.3 Ukupno 42.9 v. 20.0 + mutacija EGFR 5.5 v. 9.1 - mutacija EGFR 23.7 v. 13.3 Nikad nisu pušili 3.9 v. 6.5 Nekad pušili
The proportion of ILD-type events with a fatal outcome was 
Udio događaja tipa ILD-a sa smrtnim ishodom iznosio je 38,6%.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/ALUMINIUM FOIL LAMINATE FLOW WRAP 
BLISTER/OMOT OD SLOJEVITE ALUMINIJSKE FOLIJE
EGFR Mutation 
- mutacija EGFR