natgillin/translations-raw huggingface dataset:
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.
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).