FrancophonIA/ELRC3.0 huggingface dataset:
English: The full analysis population included 343 patients with ALK-positive advanced NSCLC as identified by Fluorescence In Situ Hybridization (FISH) prior to randomisation: 172 patients were randomised to crizotinib and 171 patients were randomised to chemotherapy (pemetrexed + carboplatin or cisplatin; up to 6 cycles of treatment).
Croatian: Potpuna analiza populacije uključivala je 343 bolesnika s ALK-pozitivnim uznapredovalim NSCLCom, kako je utvrđeno testom fluorescentne in situ hibridizacije (FISH) prije randomizacije: 172 bolesnika bila su randomizirana u skupinu krizotiniba, a 171 bolesnik u kemoterapijsku skupinu (pemetreksed + karboplatin ili cisplatin; do 6 ciklusa liječenja).
English: In Study 1014, the median duration of study treatment was 47 weeks for patients in the crizotinib arm (N=171); the median duration of treatment was 23 weeks for patients who crossed over from the chemotherapy arm to receive crizotinib treatment (N=109).
Croatian: U ispitivanju 1014, medijan trajanja ispitivanja liječenja bio je 47 tjedna za bolesnike u skupini koja je primala krizotinib (N=171); medijan trajanja liječenja bio je 23 tjedna za bolesnike koji su prešli iz skupine koja je primala kemoterapiju u skupinu koja se liječila krizotinibom (N=109).
English: According to an independent review committee (IRC) assessment of patients with ALK-positive NSCLC (N=1669), 20 (1.2%) patients had ILD/pneumonitis, including 10 (<1%) patients with fatal cases.
Croatian: Prema ocjeni Nezavisnog odbora za procjenu bolesnika s ALK-pozitivnim NSCLC-om (N=1669), 20 (1,2%) bolesnika je imalo IBP/pneumonitis, uključujući 10 (<1%) bolesnika sa smrtnim slučajem.
English: • First dose reduction: XALKORI 200 mg taken orally twice daily
Croatian: • prvo smanjenje doze: XALKORI 200 mg, primijenjen peroralno dvaput na dan
English: For ALK-positive NSCLC patients in Studies 1001 (N=154) and 1005 (N=1063), the median duration of treatment was 57 and 45 weeks, respectively.
Croatian: Za bolesnike s ALK-pozitivnim NSCLC-om u ispitivanjima 1001 (N=154) i 1005 (N=1063), medijan trajanja liječenja bio je 57 odnosno 45 tjedana.
English: • The recommended dose is one capsule of 250 mg taken orally twice daily (total amount
Croatian: • Preporučena doza je jedna kapsula od 250 mg, koja se uzima kroz usta dvaput na dan (ukupna količina 500 mg na dan).
English: For ROS1-positive NSCLC patients in Study 1001 (N=53), the median duration of treatment was 101 weeks.
Croatian: Za bolesnike s ROS1-pozitivnim NSCLC-om u ispitivanju 1001 (N=53), medijan trajanja liječenja iznosio je 101 tjedan.
English: e. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.
Croatian: U bolesnika liječenih dozom od 250 mg jedanput na dan ili onih kojima je doza smanjena na 250 mg jedanput na dan, obustaviti primjenu tijekom procjene.
English: The recommended dose schedule of XALKORI is 250 mg twice daily (500 mg daily) taken continuously.
Croatian: Preporučena doza lijeka XALKORI je 250 mg dvaput na dan (ukupno 500 mg na dan), a uzima se kontinuirano.
English: Crizotinib demonstrated antitumour efficacy, including marked cytoreductive antitumour activity, in mice bearing tumour xenografts that expressed ALK fusion proteins.
Croatian: Krizotinib je dokazao djelotvornost protiv tumora, uključujući izraženo citoreduktivno antitumorsko djelovanje, u miševa s tumorskim ksenograftima koji su izražavali proteine ALK-inačica nastalih fuzijom.
English: Agents that may increase crizotinib plasma concentrations
Croatian: Lijekovi koji mogu povisiti koncentraciju krizotiniba u plazmi
English: The most common adverse reactions (≥25%) in patients with either ALK-positive or ROS1-positive NSCLC were vision disorder, nausea, diarrhoea, vomiting, oedema, constipation, elevated transaminases, fatigue, decreased appetite, dizziness, and neuropathy.
Croatian: Najčešće nuspojave (≥ 25%) u bolesnika bilo s ALK-pozitivnim ili ROS1-pozitivnim NSCLC-om bile su poremećaj vida, mučnina, proljev, povraćanje, edem, konstipacija, povišene transaminaze, umor, smanjeni apetit, omaglica i neuropatija.
English: However, there was no observed induction in vivo when crizotinib was coadministered with the CYP3A probe substrate midazolam.
Croatian: Međutim, nije primijećena indukcija in vivo kod istodobne primjene krizotiniba s probnim supstratom CYP3A, midazolamom.
English: • Ciclosporin, sirolimus and tacrolimus used in transplant patients.
Croatian: • ciklosporinom, sirolimusom i takrolimusom - koriste se u bolesnika kojima je presađen organ.
English: • If you have reduced heart rate.
Croatian: • ako imate smanjenu brzinu srčanih otkucaja.
English: Crizotinib significantly prolonged PFS, the primary objective of the study, compared to chemotherapy as assessed by IRR.
Croatian: Krizotinib je značajno produljio PFS, primarni cilj ispitivanja, u usporedbi s kemoterapijom prema procjeni IRR-om.
English: The most serious adverse reactions in 1722 patients with either ALK-positive or ROS1-positive advanced NSCLC were hepatotoxicity, ILD/pneumonitis, neutropenia, and QT interval prolongation (see section 4.4).
Croatian: Najozbiljnije nuspojave u 1722 bolesnika bilo s ALK-pozitivnim ili ROS1-pozitivnim uznapredovalim NSCLC-om bile su hepatotoksičnost, IBP/pneumonitis, neutropenija i produljenje QT-intervala (vidjeti dio 4.4).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MAH logo)
Croatian: Pfizer Europe MA EEIG (logo nositelja odobrenja)
English: • Second dose reduction: XALKORI 250 mg taken orally once daily
Croatian: • drugo smanjenje doze: XALKORI 250 mg, primijenjen peroralno jedanput na dan
English: For patients without baseline brain metastases, the median IC-TTP was not reached in either the crizotinib (N=132) or the chemotherapy arms (N=131) (HR=0.69 [95% CI: 0.33, 1.45]; 1-sided p-value=0.1617).
Croatian: Za bolesnike bez moždanih metastaza na početku ispitivanja, medijan IC-TTP nije dostignut u skupini krizotiniba (N=132) ili kemoterapijskoj skupini (N=131) (HR=0,69 [95% CI: 0,33; 1,45]; 1-strana p-vrijednost=0,1617).
English: In vitro studies in human liver microsomes demonstrated that crizotinib is a time-dependent inhibitor of CYP2B6 and CYP3A (see section 4.5).
Croatian: Ispitivanja na ljudskim jetrenim mikrosomima in vitro pokazala su da je krizotinib inhibitor CYP2B6 i CYP3A ovisan o vremenu (vidjeti dio 4.5).
English: In randomised Phase 3 Study 1014, increases to Grade 3 or 4 ALT or AST elevations were observed in 15% and 8% of patients receiving crizotinib versus 2% and 1% of patients receiving chemotherapy.
Croatian: U randomiziranom Ispitivanju 1014 Faze 3, povišenja do stupnja 3 ili 4 ALT-a ili AST-a opažena su u 15% i 8% bolesnika koji su primali krizotinib naspram 2% i 1% bolesnika koji su primali kemoterapiju.
English: Fifty-eight of 84 (69%) patients treated with crizotinib and 17 of 119 (14%) patients treated with chemotherapy continued treatment for at least 3 weeks after objective disease progression.
Croatian: Pedeset osam od 84 (69%) bolesnika liječenih krizotinibom, i 17 od 119 (14%) bolesnika liječenih kemoterapijom, nastavilo je liječenje najmanje 3 tjedna nakon objektivne progresije bolesti.
English: Across clinical studies (n=1722), 19 (1.1%) patients treated with crizotinib had any grade cardiac failure, 8 (0.5%) patients had Grade 3 or 4, and 3 (0.2%) patients had fatal outcome.
Croatian: U kliničkim ispitivanjima (n=1722), 19 (1,1%) bolesnika liječenih krizotinibom imalo je zatajenje srca bilo kojeg stupnja, 8 (0,5%) bolesnika stupnja 3 ili 4, a 3 (0,2%) bolesnika imala su smrtni ishod. i.
English: In vitro studies indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the metabolism of medicinal products that are substrates for CYP1A2, CYP2C8, CYP2C9, CYP2C19 or CYP2D6.
Croatian: Ispitivanja in vitro pokazala su da nisu vjerojatne kliničke interakcije s drugim lijekovima kao posljedica krizotinibom posredovane inhibicije metabolizma lijekova koji su supstrati za CYP1A2, CYP2C8, CYP2C9, CYP2C19 ili CYP2D6.
English: In vitro studies suggest that crizotinib is a substrate for P-glycoprotein (P-gp).
Croatian: Ispitivanja in vitro ukazuju na to da je krizotinib supstrat P-glikoproteina (P-gp).
English: Findings observed in the female reproductive tract included single-cell necrosis of ovarian follicles of a rat given 500 mg/kg/day for 3 days.
Croatian: Nalazi na ženskim spolnim organima uključuju nekrozu pojedinačnih stanica folikula u jajnicima štakorica koje su primale dozu od 500 mg/kg na dan tijekom 3 dana.
English: Patients with or without pre-existing cardiac disorders, receiving crizotinib, should be monitored for signs and symptoms of heart failure (dyspnoea, oedema, rapid weight gain from fluid retention).
Croatian: Bolesnike s postojećim srčanim oboljenjima i one bez njih koji primaju krizotinib potrebno je nadzirati zbog moguće pojave znakova i simptoma zatajenja srca (dispneje, edema, ubrzanog porasta tjelesne težine uslijed zadržavanja tekućine).
English: No patients in the crizotinib arm of randomised Phase 3 Studies 1007 and 1014, and single arm Study 1005 were >85 years.
Croatian: Niti jedan bolesnik u skupini krizotiniba u randomiziranim Ispitivanjima 1007 i 1014 faze 3 i u Ispitivanju 1005 s jednom skupinom bolesnika nije imao >85 godina.
English: Complete blood counts including differential white blood cell counts should be monitored as clinically indicated, with more frequent repeat testing if Grade 3 or 4 abnormalities are observed, or if fever or infection occurs.
Croatian: Potrebno je kontrolirati kompletnu krvnu sliku, uključujući i diferencijalnu krvnu sliku, kako je klinički indicirano, a pretrage treba češće ponavljati ako se uoče odstupanja stupnja 3 ili 4 ili ako nastupi vrućica ili infekcija.
English: In vitro studies in human hepatocytes indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated induction of the metabolism of medicinal products that are substrates for CYP1A2.
Croatian: Ispitivanja na ljudskim hepatocitima in vitro pokazala su da nisu vjerojatne kliničke interakcije s drugim lijekovima kao posljedica krizotinibom posredovane indukcije metabolizma lijekova koji su supstrati za CYP1A2.
English: Crizotinib was aneugenic in an in vitro micronucleus assay in Chinese Hamster Ovary cells and in an in vitro human lymphocyte chromosome aberration assay.
Croatian: Krizotinib se pokazao aneugenim u in vitro mikronukleusnom testu na stanicama jajnika kineskog hrčka i u in vitro testu kromosomske aberacije na ljudskim limfocitima.
English: XALKORI dose modification - non-haematological toxicities CTCAEa Grade
Croatian: Tablica 2: Prilagodba doze lijeka XALKORI - nehematološka toksičnost Stupanj težine prema CTCAE
English: Significantly greater improvement in global QOL was observed in the crizotinib arm compared to the chemotherapy arm (overall difference in change from baseline scores 13.8; p-value <0.0001).
Croatian: Značajno veće poboljšanje u globalnoj kvaliteti života zapaženo je u skupini krizotiniba u usporedbi s kemoterapijskom skupinom (ukupna razlika u promjeni u odnosu na početne bodove 13,8; p-vrijednost <0,0001).
English: • Atazanavir, ritonavir, cobicistat, used to treat HIV infections/AIDS.
Croatian: • atazanavir, ritonavir, kobicistat - koriste se za liječenje HIV infekcije/SIDA-e.
English: Agents whose plasma concentrations may be altered by crizotinib
Croatian: Lijekovi čiju koncentraciju u plazmi može promijeniti krizotinib
English: Findings observed in the male reproductive tract included testicular pachytene spermatocyte degeneration in rats given ≥50 mg/kg/day for 28 days (approximately 1.1-fold human clinical exposure based on AUC).
Croatian: Nalazi na muškim spolnim organima uključuju pahitensku degeneraciju spermatocita u testisima štakora koji su primali dozu od ≥ 50 mg/kg na dan tijekom 28 dana (približno 1,1 puta veća izloženost u odnosu na kliničku izloženost u ljudi na temelju AUC-a).
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized predominantly by UGT1A1 (e.g., raltegravir, irinotecan) or UGT2B7 (e.g., morphine, naloxone).
Croatian: Ipak ponekad je učinak krizotiniba povećanje koncentracije u plazmi istodobno primijenjenih lijekova koji se metaboliziraju prvenstveno preko UGT1A1 (npr. raltegravir, irinotekan) ili UGT2B7 (npr. morfin, nalokson).
English: The effect of renal function as measured by baseline CLcr on observed crizotinib steady-state trough concentrations (Ctrough, ss) was evaluated.
Croatian: Ocjenjivan je učinak funkcije bubrega mjerenjem početne vrijednosti CLcr-a na opaženim najnižim koncentracijama krizotiniba u stanju dinamičke ravnoteže (Ctrough, ss).
English: Efficacy data from ROS1-positive advanced NSCLC patients from Study 1001 are provided in Table 7.
Croatian: Podaci o djelotvornosti u bolesnika s ROS1-pozitivnim uznapredovalim NSCLC-om iz Ispitivanja 1001 nalaze se u tablici 7.
English: The most frequent adverse reactions (≥3%) associated with dose reductions were elevated transaminases and neutropenia.
Croatian: Najčešće nuspojave (≥3%) povezane sa smanjenjem doze bile su povišenje transaminaza i neutropenija.
English: In 1722 patients treated with crizotinib with either ALK-positive or ROS1-positive NSCLC across clinical studies, the most frequent adverse reactions (≥3%) associated with dosing interruptions were neutropenia, elevated transaminases, vomiting, and nausea.
Croatian: U 1722 bolesnika liječenih krizotinibom s ALK-ili ROS1pozitivnim NSCLC-om u kliničkim ispitivanjima, najčešće nuspojave (≥3%) povezane s prekidom terapije su bile neutropenija, povišene transaminaze, povraćanje i mučnina.
English: The central tendency analysis indicated that the largest mean change from baseline in QTcF was 12.3 msec (95% CI 5.1-19.5 msec, least squares mean [LS] from Analysis of Variance [ANOVA]) and occurred at 6 hours post-dose on Cycle 2 Day 1.
Croatian: Analiza središnje tendencije pokazala je da je najveća srednja vrijednost promjene u odnosu na početne vrijednosti QTcF-intervala bila 12,3 msek (95% CI 5,1-19,5 msek, srednja vrijednost procijenjena metodom najmanjih kvadrata [LS] iz analize varijance [ANOVA]) i javila se 6 sati nakon doze 1. dana 2. ciklusa.
English: Efficacy data from Studies 1001 and 1005 are provided in Table 6.
Croatian: U Tablici 6 prikazani su podaci o djelotvornosti u Ispitivanjima 1001 i 1005.
English: Sixty-five of 89 (73%) patients treated with crizotinib and 11 of 132 (8.3%) patients treated with chemotherapy continued treatment for at least 3 weeks after objective disease progression.
Croatian: Šezdeset pet od 89 (73%) bolesnika liječenih krizotinibom i 11 od 132 (8,3%) bolesnika liječenih kemoterapijom nastavilo je liječenje najmanje 3 tjedna nakon objektivne progresije bolesti.
English: In vitro studies indicated that crizotinib is an inhibitor of CYP2B6.
Croatian: In vitro ispitivanja pokazala su da je krizotinib inhibitor enzima CYP2B6.
English: • Increased blood levels of creatinine (may indicate that kidneys are not functioning properly).
Croatian: • povišene razine kreatinina u krvi (mogu ukazivati na neispravan rad bubrega).
English: Number of deaths, n (%) Overall Survivalc [median (95% CI)] months
Croatian: Broj smrtnih slučajeva, n (%) Ukupno preživljenje c [medijan (95% CI)] mjeseci
English: The median duration of treatment was 22.4 months (95% CI: 15.0, 35.9).
Croatian: Medijan trajanja liječenja iznosio je 22,4 mjeseca (95% CI: 15,0; 35,9).
English: Patients could continue treatment as assigned beyond the time of RECIST-defined disease progression at the discretion of the investigator if the patient was perceived to be experiencing clinical benefit.
Croatian: Bolesnici su mogli nastaviti liječenje nakon vremena progresije bolesti definirane RECIST-om prema odluci ispitivača ako se smatralo da bolesnik ima kliničku korist.
English: However, in vitro studies indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the metabolism of drugs that are substrates for UGT1A4, UGT1A6, or UGT1A9.
Croatian: Međutim, in vitro ispitivanja pokazala su da nisu vjerojatne kliničke interakcije s drugim lijekovima kao posljedica krizotinibom posredovane inhibicije metabolizma lijekova koji su supstrati za UGT1A4, UGT1A6 ili UGT1A9.
English: Crizotinib showed a significantly greater improvement from baseline compared to chemotherapy in alopecia (Cycles 2 to 15; p-value <0.05), cough (Cycles 2 to 20; p-value <0.0001), dyspnoea (Cycles 2 to 20; p-value <0.0001), haemoptysis (Cycles 2 to 20; p-value <0.05), pain in arm or shoulder (Cycles 2 to 20; p-value <0.0001), pain in chest (Cycles 2 to 20; p-value <0.0001), and pain in other parts (Cycles 2 to 20; p-value <0.05).
Croatian: Krizotinib je pokazao značajno veće poboljšanje u odnosu na početne vrijednosti u usporedbi s kemoterapijom kod alopecije (Ciklusi od 2. do 15.; p-vrijednost<0,05), kašlja (Ciklusi od 2. do 20.; pvrijednost<0,0001), dispneje (Ciklusi od 2. do 20.; p<0,0001), hemoptize (Ciklusi od 2. do 20.; pvrijednost<0,05), boli u ruci ili ramenu (Ciklusi od 2. do 20.; p-vrijednost<0,0001), boli u prsištu (Ciklusi od 2. do 20.; p-vrijednost<0,0001) i boli u drugim predjelima (Ciklusi od 2. do 20.; pvrijednost<0,05).
English: Table 6: ALK-positive advanced NSCLC efficacy results from Studies 1001 and 1005 Efficacy Parameter
Croatian: Tablica 6. Rezultati djelotvornosti u ALK-pozitivnom, uznapredovalom NSCLC-u u Ispitivanjima 1001 i 1005
English: If you have any further questions, ask your doctor, pharmacist, or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: For patients who develop haematologic laboratory abnormalities, see section 4.2.
Croatian: Za bolesnike u kojih dođe do hematoloških laboratorijskih odstupanja, vidjeti dio 4.2.
English: The PFS benefit of crizotinib was consistent across subgroups of baseline patient characteristics such as age, gender, race, smoking class, time since diagnosis, ECOG performance status, and presence of brain metastases.
Croatian: Korist krizotiniba za PFS bila je konzistentna u podskupinama svih početnih obilježja bolesnika kao što su dob, spol, rasa, pušački status, vrijeme od dijagnoze, opće stanje prema ljestvici ECOG i prisutnost moždanih metastaza.
English: Non-adenocarcinoma histology
Croatian: Tumor koji histološki nije adenokarcinom
English: All-causality neuropathy, as defined in Table 3, was experienced by 435 (25%) out of 1722 patients treated with crizotinib.
Croatian: Neuropatija svih uzroka nastala tijekom liječenja, kako je definirana u Tablici 3, javila se u 435 (25%) od 1722 bolesnika liječenih krizotinibom.
English: In randomised Phase 3 Study 1007, increases to Grade 3 or 4 ALT or AST elevations were observed in 18% and 9% of patients receiving crizotinib and 5% and <1% of patients receiving chemotherapy.
Croatian: U randomiziranom Ispitivanju 1007 Faze 3, povišenje vrijednosti ALT-a ili AST-a do stupnja 3 ili 4 opažena su u 18% i 9% bolesnika koji su primali krizotinib te u 5% i <1% bolesnika koji su primali kemoterapiju.
English: Bradycardia has been reported during clinical studies; therefore, use crizotinib with caution due to the risk of excessive bradycardia when used in combination with other bradycardic agents (e.g., non-dihydropyridine calcium channel blockers such as verapamil and diltiazem, beta-blockers, clonidine, guanfacine, digoxin, mefloquine, anticholinesterases, pilocarpine) (see sections 4.2 and 4.4).
Croatian: U kliničkim je ispitivanjima prijavljena bradikardija; stoga je, zbog rizika od prekomjerne bradikardije, potreban oprez kod primjene krizotiniba u kombinaciji s drugim lijekovima koji uzrokuju bradikardiju (npr. nedihidropiridinski blokatori kalcijevih kanala poput verapamila i diltiazema, betablokatori, klonidin, gvanfacin, digoksin, meflokin, antikolinesteraze, pilokarpin) (vidjeti dijelove 4.2 i
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized by CYP2B6 (e.g., bupropion, efavirenz).
Croatian: Stoga krizotinib može imati potencijal za povećanje koncentracije istodobno primijenjenih lijekova koji se metaboliziraju putem enzima CYP2B6 (npr. bupropion, efavirenz) u plazmi.
English: Patients randomised to chemotherapy could crossover to receive crizotinib upon RECIST-defined disease progression confirmed by IRR.
Croatian: Bolesnici randomizirani za kemoterapiju mogli su preći u skupinu koja je primala krizotinib nakon što je IRR-om potvrđena progresija bolesti definirana RECIST-om.
English: Small increases of structural chromosomal aberrations at cytotoxic concentrations were seen in human lymphocytes.
Croatian: Na ljudskim je limfocitima opažen malo povećan broj strukturnih kromosomskih aberacija pri citotoksičnim koncentracijama.
English: Post-implantation loss was increased at doses ≥50 mg/kg/day (approximately 0.4 times the AUC at the recommended human dose) in rats, and reduced fetal body weights were considered adverse effects in the rat and rabbit at 200 and 60 mg/kg/day, respectively (approximately 1.2-fold human clinical exposure based on AUC).
Croatian: U štakora je zabilježen povećan gubitak ploda nakon implantacije pri dozama od ≥ 50 mg/kg na dan (izloženost približno 0,4 puta veća od AUC-a pri preporučenoj dozi za ljude), dok se štetnim učinkom smatrala smanjena tjelesna težina ploda u štakora i kunića pri dozama od 200 odnosno 60 mg/kg na dan (približno 1,2 puta veća izloženost u odnosu na kliničku, na temelju AUC-a).
English: The full analysis population included 347 patients with ALK-positive advanced NSCLC as identified by FISH prior to randomisation.
Croatian: Potpuna analiza populacije uključivala je 347 bolesnika s ALK-pozitivnim uznapredovalim NSCLCom, kako je utvrđeno testom fluorescentne in situ hibridizacije (FISH) prije randomizacije.
English: Therefore, coadministration of crizotinib with CYP3A substrates with narrow therapeutic indices, including but not limited to alfentanil, cisapride, cyclosporine, ergot derivatives, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus should be avoided (see section 4.4).
Croatian: Stoga treba izbjegavati istodobnu primjenu krizotiniba sa supstratima CYP3A uskog terapijskog indeksa, uključujući, no ne ograničavajući se na alfentanil, cisaprid, ciklosporin, derivate ergota, fentanil, pimozid, kinidin, sirolimus i takrolimus (vidjeti dio 4.4).
English: Following the administration of a single 250 mg radiolabeled crizotinib dose to healthy subjects, 63% and 22% of the administered dose was recovered in faeces and urine, respectively.
Croatian: Nakon primjene jedne doze od 250 mg radioaktivno označenog krizotiniba u zdravih ispitanika, 63% primijenjene doze ustanovljeno je u fecesu, a 22% u mokraći.
English: A total of 162 patients in the crizotinib arm and 151 patients in the chemotherapy arm had completed the EORTC QLQ-C30 and LC13 questionnaires at baseline and at least 1 postbaseline visit.
Croatian: Ukupno 162 bolesnika u skupini krizotiniba i 151 bolesnika u kemoterapijskoj skupini ispunilo je upitnike EORTC QLQ-C30 i LC-13 na početku ispitivanja i najmanje 1 nakon početnog posjeta.
English: Cardiac failureh (1%) Electrocardiogram QT prolonged (4%) Syncope (3%)
Croatian: Srčani poremećaji omaglica f (26%) bradikardija g zatajenje srca h (1%) produljenje QT-intervala na EKG-u (4%) sinkopa (3%)
English: Capsule shell: gelatin, titanium dioxide (E171), and red iron oxide (E172).
Croatian: Ovojnica kapsule: želatina, titanijev dioksid (E171) i crveni željezov oksid (E172).
English: Following 28 days of crizotinib dosing at 250 mg taken twice daily in cancer patients, the oral midazolam AUCinf was 3.7-fold of those seen when midazolam was administered alone, suggesting that crizotinib is a moderate inhibitor of CYP3A.
Croatian: Nakon 28-dnevne primjene krizotiniba u dozi od 250 mg dvaput na dan u onkoloških bolesnika, AUCinf peroralno primijenjenog midazolama bio je 3,7 puta veći nego kada se midazolam davao samostalno, što ukazuje na to da je krizotinib umjeren inhibitor CYP3A.