FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“ odnosno „Rok valjanosti“.
English: Infections and infestations Infection*
Croatian: Infekcija*
English: Therefore, patients who are still smoking should be encouraged to stop smoking as early as possible before initiation of treatment with Tarceva, as plasma erlotinib concentrations are reduced otherwise.
Croatian: Stoga bolesnicima koji puše treba savjetovati da prestanu pušiti što je ranije moguće prije početka terapije lijekom Tarceva jer u protivnom može doći do smanjenja koncentracije erlotiniba u plazmi.
English: Tarceva should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Croatian: Tarceva se treba primjenjivati s oprezom u bolesnika koji su ranije bolovali od keratitisa, ulceroznog keratitisa ili jako suhih očiju.
English: The geometric mean of the AUC0-inf was 18726 ng•h/mL in the non-smokers and 6718 ng•h/mL in the smokers with a mean ratio of 35.9% (95% CI: 23.7 to 54.3, p < 0.0001).
Croatian: Geometrijska sredina AUC0-inf iznosila je 18726 ng·h/ml u nepušača i 6718 ng·h/ml u pušača, uz srednji omjer od 35,9% (95% CI: 23,7 - 54,3, p < 0,0001).
English: The adjusted hazard ratio (HR) for death in the Tarceva group relative to the placebo group was 0.73 (95% CI, 0.60 to 0.87) (p = 0.001).
Croatian: Prilagođeni omjer rizika (HR) smrti u Tarceva skupini u odnosu na placebo skupinu bio je 0,73 (95% CI, 0,60 - 0,87) (p = 0,001).
English: Adverse drug reactions from clinical trials (Table 1) are listed by MedDRA system organ class.
Croatian: Nuspojave lijeka iz kliničkih ispitivanja (Tablica 1) navedene su prema MedDRA klasifikaciji organskih sustava.
English: In this study, the overall population showed a benefit for the primary PFS end-point (HR= 0.71 p< 0.0001) and the secondary OS end-point (HR= 0.81 p=0.0088).
Croatian: U ovom je ispitivanju ukupna populacija ostvarila korist s obzirom na PFS kao primarnu mjeru ishoda (HR = 0,71, p < 0,0001) i OS kao sekundarnu mjeru ishoda (HR = 0,81, p = 0,0088).
English: In population pharmacokinetic analysis, increased serum concentrations of total bilirubin were associated with a slower rate of erlotinib clearance.
Croatian: U farmakokinetičkoj populacijskoj analizi povišenje koncentracije ukupnog bilirubina u serumu bilo je povezano sa sporijim klirensom erlotiniba.
English: Roche Oy Puh/Tel: +358 (0) 10 554 500
Croatian: Puh/Tel: +358 (0) 10 554 500
English: After oral administration, erlotinib peak plasma levels are obtained in approximately 4 hours after oral dosing.
Croatian: Nakon peroralne primjene vršna razina erlotiniba u plazmi postiže se nakon otprilike četiri sata.
English: DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Figure 1: Kaplan-Meier curve for investigator assessed PFS in trial ML20650 (EURTAC) (April 2012 cut-off)
Croatian: Slika 1: Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema ocjeni ispitivača u ispitivanju ML20650 (EURTAC) (zaključni datum prikupljanja podataka travanj 2012.)
English: Erlotinib binds to serum albumin and alpha-1 acid glycoprotein (AAG).
Croatian: Erlotinib se veže za serumski albumin i alfa-1 kiseli glikoprotein (AAG).
English: Caution should be exercised when ciprofloxacin or potent CYP1A2 inhibitors (e.g. fluvoxamine) are combined with erlotinib.
Croatian: Potreban je oprez ako se ciprofloksacin ili jaki CYP1A2 inhibitori (npr. fluvoksamin) kombiniraju s erlotinibom.
English: In a clinical study, the concomitant use of erlotinib and rifampicin (600 mg orally once daily for 7 days), a potent CYP3A4 inducer, resulted in a 69% decrease in the median erlotinib AUC.
Croatian: U kliničkim ispitivanjima pokazalo se da istovremena primjena erlotiniba i rifampicina (600 mg peroralno, jednom dnevno, tijekom 7 dana), jakog CYP3A4 induktora, dovodi do 69%-tnog smanjenja medijana AUC-a erlotiniba.
English: Tarceva is indicated for adults.
Croatian: Tarceva je namijenjena liječenju odraslih bolesnika.
English: *** Rash included dermatitis acneiform.
Croatian: *** Osipi su obuhvaćali akneiformni dermatitis.
English: Erlotinib and Gemcitabine
Croatian: Erlotinib i gemcitabin
English: It is not known whether erlotinib is excreted in human milk.
Croatian: Nije poznato izlučuje li se erlotinib u majčino mlijeko.
English: This study was conducted in Caucasian patients with metastatic or locally advanced NSCLC (stage IIIB and IV) who have not received previous chemotherapy or any systemic antitumour therapy for their advanced disease and who present mutations in the tyrosine kinase domain of the EGFR (exon 19 deletion or exon 21 mutation).
Croatian: Ovo je ispitivanje provedeno u bijelaca s metastatskim ili lokalno uznapredovalim NSCLC-om (stadija IIIB i IV) koji prethodno nisu liječeni kemoterapijom ili bilo kakvim sistemskim antitumorskim liječenjem za svoju uznapredovalu bolest, a koji su imali mutacije u domeni tirozin kinaze EGFR-a (delecija eksona 19 ili mutacija na eksonu 21).
English: Exploratory Analysis (40% OS maturity) (n=173)
Croatian: Eksplorativna analiza (sa 40% podataka za OS) (n=173)
English: Baseline demographic and disease characteristics of the patients were similar between the 2 treatment groups, 100 mg Tarceva plus gemcitabine or placebo plus gemcitabine, except for a slightly larger proportion of females in the erlotinib/gemcitabine arm compared with the placebo/gemcitabine arm:
Croatian: Demografske karakteristike i karakteristike bolesti kod bolesnika na početku ispitivanja bile su slične u obje liječene skupine, u skupini koja je primala lijek Tarceva 100 mg i gemcitabin ili u skupini koja je primala placebo i gemcitabin, izuzev neznatno većeg udjela žena u erlotinib/gemcitabin skupini naspram placebo/gemcitabin skupine:
English: Reduced exposure may also occur with other inducers e.g. phenytoin, carbamazepine, barbiturates or St. John's Wort (hypericum perforatum).
Croatian: Smanjena raspoloživost može se pojaviti kod primjene erlotiniba s ostalim induktorima, npr. fenitoinom, karbamazepinom, barbituratima ili gospinom travom (Hypericum perforatum).
English: Women of childbearing potential must be advised to avoid pregnancy while on Tarceva.
Croatian: Ženama u reproduktivnoj dobi treba savjetovati da izbjegavaju trudnoću za vrijeme primjene lijeka Tarceva.
English: The secondary endpoint of PFS showed no difference between Tarceva and placebo in maintenance treatment (HR=0.94, 95 % CI, 0.80 to 1.11; p=0.48).
Croatian: Sekundarna mjera ishoda (PFS) nije pokazala razliku između lijeka Tarceva i placeba u terapiji održavanja (HR = 0,94; 95% CI: 0,80 - 1,11; p = 0,48).
English: In a randomised double-blind study (BR.21; Tarceva administered as second line therapy), rash (75%) and diarrhoea (54%) were the most commonly reported adverse drug reactions (ADRs).
Croatian: U randomiziranom, dvostruko slijepom ispitivanju (BR.21; Tarceva primjenjena kao druga linija terapije), najčešće prijavljivane nuspojave su bile osip (75%) i proljev (54%).
English: -Gastrointestinal perforations7
Croatian: - gastrointestinalne perforacije 7
English: Significant interactions with the clearance of other CYP3A4 substrates are therefore unlikely.
Croatian: Stoga nije vjerojatan značajan utjecaj na klirens ostalih CYP3A4 supstrata.
English: Use of Tarceva in paediatric patients is not recommended.
Croatian: Ne preporučuje se primjena lijeka Tarceva u pedijatrijskih bolesnika.
English: Cases of interstitial lung disease (ILD)-like events, including fatalities, have been reported uncommonly in patients receiving Tarceva for treatment of non-small cell lung cancer (NSCLC), pancreatic cancer or other advanced solid tumours.
Croatian: Intersticijska bolest pluća Slučajevi nalik intersticijskoj bolesti pluća (IBP), uključujući i smrtni ishod, prijavljeni su manje često u bolesnika koji primaju lijek Tarceva za liječenje raka pluća nemalih stanica (NSCLC), raka gušterače ili drugih uznapredovalih solidnih tumora.
English: Potent inducers of CYP3A4 may reduce the efficacy of erlotinib whereas potent inhibitors of CYP3A4 may lead to increased toxicity.
Croatian: Jaki induktori CYP3A4 mogu smanjiti djelotvornost erlotiniba, a jaki inhibitori CYP3A4 mogu dovesti do povećane toksičnosti.
English: Therefore, caution should be used when erlotinib is combined with a potent CYP3A4 inhibitor, e.g. azole antifungals (i.e. ketoconazole, itraconazole, voriconazole), protease inhibitors, erythromycin or clarithromycin.
Croatian: Stoga je potreban oprez prilikom kombiniranja erlotiniba s jakim CYP3A4 inhibitorom, npr. lijekom protiv gljivica (ketokonazolom, itrakonazolom, vorikonazolom), inhibitorima proteaze, eritromicinom ili klaritromicinom.
English: Diarrhoea and vomiting (very common: may affect more than 1 out of 10 people).
Croatian: Proljev i povraćanje (vrlo često: mogu se javiti kod više od 1 na 10 osoba).
English: Erlotinib is excreted predominantly as metabolites via the faeces (>90%) with renal elimination accounting for only a small amount (approximately 9%) of an oral dose.
Croatian: Erlotinib se uglavnom izlučuje u obliku metabolita putem fecesa (> 90%), dok se manji dio peroralne doze uklanja putem bubrega (otprilike 9%).
English: About two-thirds of the patients were male and approximately one-third had a baseline ECOG performance status (PS) of 2, and 9% had a baseline ECOG PS of 3.
Croatian: Približno dvije trećine bolesnika činili su muškarci, otprilike jedna trećina imala je početni ECOG funkcionalni status 2 (engl.
English: Based on the data from the CURRENTS study, no evidence was seen for any benefit of a higher erlotinib dose of 300 mg when compared with the recommended dose of 150 mg in active smokers.
Croatian: Prema podacima iz ispitivanja CURRENTS, nije bilo dokaza da je korist liječenja u aktivnih pušača veća kod primjene više doze erlotiniba (300 mg) nego kod primjene preporučene doze od 150 mg.
English: Erlotinib potently inhibits the intracellular phosphorylation of EGFR.
Croatian: Erlotinib snažno inhibira unutarstaničnu fosforilaciju EGFR-a.
English: The percent of patients alive at 12 months was 31.2% and 21.5%, for the Tarceva and placebo groups, respectively.
Croatian: Postotak bolesnika koji su preživjeli 12 mjeseci bio je 31,2% u skupini koja je primala lijek Tarceva i 21,5% u placebo skupini.
English: The efficacy and safety of Tarceva as second/third-line therapy was demonstrated in a randomised, double-blind, placebo-controlled trial (BR.21), in 731 patients with locally advanced or metastatic NSCLC after failure of at least one chemotherapy regimen.
Croatian: Djelotvornost i sigurnost primjene lijeka Tarceva u drugoj i trećoj liniji liječenja pokazana je u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju (BR.21), provedenom u 731 bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica nakon neuspjeha primjene barem jednog kemoterapijskog protokola.
English: Paediatric population There have been no specific studies in paediatric patients.
Croatian: Ne postoje posebne studije u pedijatrijskih bolesnika.
English: The median time to onset of rash was 10 days.
Croatian: Medijan vremena do pojave osipa iznosio je 10 dana.
English: Tarceva contains the active substance erlotinib.
Croatian: Tarceva sadrži djelatnu tvar erlotinib.
English: 3 Including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumours (see section 4.4).
Croatian: uključujući smrtne slučajeve, u bolesnika koji su primali lijek Tarceva zbog liječenja raka pluća nemalih stanica ili drugih uznapredovalih solidnih tumora (vidjeti dio 4.4).
English: Tarceva treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Croatian: Liječenje lijekom Tarceva treba nadzirati liječnik s iskustvom u primjeni antineoplastičnih lijekova.
English: Red blood cell parameters were decreased and white blood cells, primarily neutrophils, were increased.
Croatian: Parametri eritrocita smanjili su se, dok su leukociti, uglavnom neutrofili, bili povećani.
English: Based on the results of pharmacokinetic studies, current smokers should be advised to stop smoking while taking Tarceva, as plasma concentrations could be reduced otherwise.
Croatian: Na temelju rezultata farmakokinetičkih ispitivanja bolesnicima koji puše potrebno je savjetovati da prestanu pušiti za vrijeme liječenja lijekom Tarceva jer u protivnom može doći do smanjenja koncentracije lijeka u plazmi.
English: Concomitant administration of Tarceva with 300 mg ranitidine, an H2-receptor antagonist, decreased erlotinib exposure [AUC] and maximum concentrations [Cmax] by 33% and 54%, respectively.
Croatian: Istovremena primjena lijeka Tarceva s 300 mg ranitidina, antagonista H2 receptora, smanjuje izloženost erlotinibu [AUC] za 33% i vršne koncentracije [Cmax] za 54%.
English: Safety data were comparable between the 300 mg and 150 mg doses; however, there was a numerical increase in the incidence of rash, interstitial lung disease and diarrhoea, in patients receiving the higher dose of erlotinib (see sections 4.2, 4.4, 5.1 and 5.2).
Croatian: Podaci o sigurnosti za doze od 300 mg i 150 mg bili su usporedivi; međutim, u bolesnika koji su primali višu dozu erlotiniba zabilježeno je brojčano povećanje incidencije osipa, intersticijske bolesti pluća i proljeva (vidjeti dijelove 4.2, 4.4, 5.1 i 5.2).
English: The proportion of patients who experienced complete response, partial response or stable disease was 44.0% and 27.5%, respectively, for the Tarceva and placebo groups (p = 0.004).
Croatian: Udio bolesnika u kojih je došlo do potpunog odgovora, djelomičnog odgovora ili stabilizacije bolesti u skupinama koje su primale lijek Tarceva iznosio je 44,0%, a u skupinama koje su primale placebo 27,5% (p = 0,004).
English: • Cases of perforation or ulceration of the cornea
Croatian: · slučajevi oštećenja ili puknuća rožnice
English: In some cases your doctor may need to reduce your dose of Tarceva or interrupt treatment:
Croatian: U nekim će slučajevima liječnik morati smanjiti dozu lijeka Tarceva ili obustaviti liječenje.
English: -Corneal perforations -Corneal ulcerations -Uveitis
Croatian: - ulceracije rožnice - perforacije rožnice - uveitis
English: Frequency category of highest incidence
Croatian: Kategorija najveće učestalosti
English: What you need to know before you take Tarceva Do not take Tarceva:
Croatian: Što morate znati prije nego počnete uzimati lijek Tarceva
English: Updated Analysis (62% OS maturity) (n=173)
Croatian: Dopunjena analiza (sa 62% podataka za OS) (n=173)
English: In the Tarceva plus gemcitabine arm, Grade 3/4 rash and diarrhoea were each reported in 5% of patients.
Croatian: U skupini koja je primala lijek Tarceva i gemcitabin osip i proljev stupnja 3/4 prijavljeni su svaki u 5% bolesnika.
English: Erlotinib is a potent inhibitor of CYP1A1, and a moderate inhibitor of CYP3A4 and CYP2C8, as well as a strong inhibitor of glucuronidation by UGT1A1 in vitro.
Croatian: Erlotinib je jak inhibitor CYP1A1 i umjeren inhibitor CYP3A4 i CYP2C8 te jak inhibitor glukuronidacije UGT1A1 in vitro.
English: The median overall survival was 6.7 months in the Tarceva group (95% CI, 5.5 to 7.8 months) compared with 4.7 months in the placebo group (95% CI, 4.1 to 6.3 months).
Croatian: Medijan ukupnog preživljenja u skupini koja je primala lijek Tarceva bilo je 6,7 mjeseci (95% CI, 5,5 - 7,8 mjeseci), u usporedbi s 4,7 mjeseci u placebo skupini (95% CI, 4,1 - 6,3 mjeseca).
English: If the use of ranitidine is considered, it should be used in a staggered manner; i.e. Tarceva must be taken at least 2 hours before or 10 hours after ranitidine dosing.
Croatian: Ako je potrebno uzimati ranitidin treba ga uzimati načinom naizmjenično npr. Tarceva se mora uzimati najmanje 2 sata prije ili 10 sati nakon primjene ranitidina.
English: Erlotinib and coumarin-derived anticoagulants
Croatian: Erlotinib i kumarinski antikoagulansi
English: However, when Tarceva was dosed in a staggered manner 2 hours before or 10 hours after ranitidine 150 mg b.i.d., erlotinib exposure [AUC] and maximum concentrations [Cmax] decreased only by 15% and 17%, respectively.
Croatian: Međutim, kada se Tarceva primjenjuje načinom naizmjenično 2 sata prije ili 10 sati nakon primjene ranitidina dva puta dnevno, izloženost erlotiniba se smanjuje samo za [AUC] 15% i vršne koncentracije [Cmax] za 17%.
English: In rare cases liver failure was observed (rare: may affect up to 1 in 1,000 people).
Croatian: U rijetkim slučajevima opaženo je zatajenje jetre (rijetko: može se javiti kod manje od 1 na 1000 osoba).
English: Patients with pancreatic cancer
Croatian: Bolesnici s rakom gušterače
English: Co-administration of Tarceva with CYP3A4 inducers should therefore be avoided.
Croatian: Stoga valja izbjegavati istovremeno uzimanje lijeka Tarceva i CYP3A4 induktora.
English: OS of Tarceva in first line maintenance was not superior to Tarceva as second line treatment in patients whose tumor did not harbor an EGFR-activating mutation (HR= 1.02, 95% CI, 0.85 to 1.22, p=0.82).
Croatian: OS uz primjenu lijeka Tarceva kao prve linije terapije održavanja u bolesnika čiji tumor nije imao aktivirajuću mutaciju EGFR-a nije bio superioran u odnosu na OS ostvaren kada se Tarceva primjenjivala kao druga linija liječenja (HR = 1,02; 95% CI: 0,85 - 1,22; p = 0,82).
English: The effect of antacids on the absorption of erlotinib has not been investigated but absorption may be impaired, leading to lower plasma levels.
Croatian: Nije ispitan učinak antacida na apsorpciju erlotiniba, ali može doći do poremećaja apsorpcije, što dovodi do nižih razina lijeka u plazmi.
English: Secondary efficacy endpoints were all consistent with the primary endpoint and no difference was detected for OS between patients treated with erlotinib 300 mg and 150 mg daily (HR 1.03, 95% CI 0.80 to 1.32).
Croatian: Sve sekundarne mjere ishoda za djelotvornost bile su u skladu s primarnom mjerom ishoda te nije opažena razlika za OS između bolesnika liječenih erlotinibom u dozi od 300 mg na dan i onih koji su primali dozu od 150 mg na dan (HR: 1,03; 95% CI: 0,80 - 1,32).
English: The most frequent ADRs seen in patients treated with Tarceva in studies BO18192 and BO25460 were rash (BO18192: all grades 49.2%, grade 3: 6.0%; BO25460: all grades 39.4%, grade 3: 5.0%) and diarrhoea (BO18192: all grades 20.3%, grade 3: 1.8%; BO25460: all grades 24.2%, grade 3: 2.5%).
Croatian: BO25460 bile su osip (BO18192 - bilo kojeg stupnja: 49,2%; stupnja 3: 6,0%; BO25460 - bilo kojeg stupnja: 39,4%; stupnja 3: 5,0%) i proljev (BO18192 - bilo kojeg stupnja: 20,3%; stupnja 3: 1,8%;
English: Grade 3/4 rash and diarrhoea occurred in 9% and 6%, respectively in Tarceva-treated patients and each resulted in study discontinuation in 1% of patients.
Croatian: Osip i proljev stupnja 3/4 opaženi su u 9% odnosno 6% slučajeva u bolesnika koji uzimaju lijek Tarceva, a oba su dovela do prekida liječenja u 1% bolesnika.
English: The median PFS was 9.7 weeks in the Tarceva group (95% CI, 8.4 to 12.4 weeks) compared with 8.0 weeks in the placebo group (95% CI, 7.9 to 8.1 weeks).
Croatian: Medijan PFS bilo je 9,7 tjedana u skupini koja je primala lijek Tarceva (95% CI, 8,4 - 12,4 tjedana) u usporedbi s 8,0 tjedana u skupini koja je primala placebo (95% CI, 7,9 - 8,1 tjedan).
English: This was evidenced by a hazard ratio for death of 0.82 (95% CI, 0.68 to 0.99) among patients whose best response was stable disease or progressive disease.
Croatian: 0,68 - 0,99) među bolesnicima čiji je najbolji odgovor bio stabilna bolest ili progresivna bolest.
English: Baseline demographic and disease characteristics were well balanced between the two treatment arms.
Croatian: Demografske karakteristike i karakteristike bolesti na početku ispitivanja bile su dobro uravnotežene u obje terapijske skupine.
English: Increasing the dose of Tarceva when co-administered with such agents is not likely to compensate for the loss of exposure.
Croatian: Povećanje doze lijeka Tarceva pri istovremenoj primjeni s takvim lijekovima vjerojatno neće nadoknaditi gubitak izloženosti lijeku.
English: Form of lung irritation called interstitial lung disease (uncommon in European patients; common in Japanese patients: may affect up to 1 in 100 people in Europe and up to 1 in 10 in Japan).
Croatian: Oblik iritacije pluća poznate pod nazivom intersticijska bolest pluća (manje često u europskih bolesnika; često u japanskih bolesnika: može se javiti kod manje od 1 na
English: Use of Tarceva in patients with severe hepatic dysfunction is not recommended (see section 5.2).
Croatian: Ne preporučuje se primjena u bolesnika s teškim poremećajima funkcije jetre (vidjeti dio 5.2).
English: The safety and efficacy of erlotinib has not been studied in patients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT> 5 x ULN).
Croatian: Sigurnost i djelotvornost erlotiniba u bolesnika s teškim poremećajima funkcije jetre (AST/SGOT i ALT/SGPT > 5 x gornja granica normalnih vrijednosti) nije ispitana.
English: Progression Free Survival (PFS, median in months)* Investigator Assessed **
Croatian: Primarna mjera ishoda: Preživljenje bez progresije bolesti (PFS, medijan u mjesecima)*
English: The efficacy and safety of Tarceva as maintenance after first-line chemotherapy for NSCLC was investigated in a randomised, double-blind, placebo-controlled trial (BO18192, SATURN).
Croatian: Djelotvornost i sigurnost lijeka Tarceva u terapiji održavanja nakon prve linije kemoterapije raka pluća nemalih stanica ispitivale su se u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju (BO18192, SATURN).
English: In the pivotal Phase III NSCLC trial, current smokers achieved erlotinib steady state trough plasma concentration of 0.65 µg/mL (n=16) which was approximately 2-fold less than the former smokers or patients who had never smoked (1.28 µg/mL, n=108).
Croatian: U pivotalnom ispitivanju faze III raka pluća nemalih stanica pušači su ostvarili najnižu koncentraciju erlotiniba u plazmi u stanju dinamičke ravnoteže od 0,65 µg/ml (n=16) što je približno bilo dva puta manje od bolesnika koji su bivši pušači ili koji nikad nisu pušili (1,28 µg/ml, n=108).
English: Hepatitis, hepatic failure
Croatian: Hepatitis, zatajenje jetre
English: Alternate treatments lacking potent CYP3A4 inducing activity should be considered when possible.
Croatian: Potrebno je uzeti u obzir alternativna liječenja bez jake CYP3A4 indukcijske aktivnosti.
English: Loss of appetite, decreased weight
Croatian: · infekcija, · gubitak apetita, smanjenje tjelesne težine, · depresija,
English: Metastatic Population
Croatian: Populacija s metastatskom bolešću
English: Each film-coated tablet contains 25 mg, 100 mg or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the strength.
Croatian: Jedna filmom obložena tableta sadrži 25 mg, 100 mg ili 150 mg erlotiniba (u obliku erlotinibklorida), ovisno o jačini.
English: No data are available regarding the influence of severe hepatic dysfunction on the pharmacokinetics of erlotinib.
Croatian: Nema dostupnih podataka o utjecaju teškog poremećaja funkcije jetre na farmakokinetiku erlotiniba.
English: Erlotinib is a substrate for the P-glycoprotein active substance transporter.
Croatian: Erlotinib je supstrat P-glikoproteina (Pgp), prijenosnika aktivnih tvari.
English: Co-administration of erlotinib with omeprazole, a proton pump inhibitor (PPI), decreased the erlotinib exposure [AUC] and maximum concentration [Cmax] by 46% and 61%, respectively.
Croatian: Istovremenom primjenom erlotiniba i omeprazola, inhibitora protonske pumpe, došlo je do smanjenja raspoloživosti erlotiniba [AUC] za 46% i vršne koncentracije [Cmax] za 61%.
English: If you could become pregnant, use adequate contraception during treatment, and for at least 2 weeks after taking the last tablet.
Croatian: Ako biste mogli zatrudnjeti, tijekom liječenja i barem još 2 tjedna nakon uzimanja posljednje tablete koristite odgovarajuću kontracepciju.