FrancophonIA/ELRC3.0 huggingface dataset:
English: h. Cardiac failure (Cardiac failure, Cardiac failure congestive, Ejection fraction decreased, Left ventricular failure, Pulmonary oedema).
Croatian: h. Zatajenje srca (zatajenje srca, kongestivno zatajenje srca, smanjena istisna frakcija, zatajenje lijeve klijetke, plućni edem).
English: Of 171 ALK-positive NSCLC patients treated with crizotinib in randomised Phase 3 Study 1014, 22 (13%) were 65 years or older, and of 109 ALK-positive patients treated with crizotinib who crossed over from chemotherapy arm, 26 (24%) were 65 years or older.
Croatian: Od 171 bolesnika s ALK-pozitivnim NSCLC-om liječenih krizotinibom u randomiziranom Ispitivanju 1014 faze 3, 22 (13%) ih je imalo 65 ili više godina, a od 109 ALK-pozitivnih bolesnika liječenih krizotinibom koji su prešli iz kemoterapijske skupine, 26 (24%) ih je imalo 65 ili više godina.
English: Renal failure and acute renal failure were reported in patients treated with crizotinib in clinical trials and during post marketing.
Croatian: Zatajenje bubrega i akutno zatajenje bubrega je prijavljeno kod bolesnika liječenih krizotinibom u kliničkim ispitivanjima i nakon stavljanja lijeka u promet.
English: In Study 1005, the adjusted geometric mean Ctrough, ss of crizotinib in mild (N=191) and moderate (N=65) renal impairment groups were 9.1% and 15% higher, respectively, than those in patients with normal renal function.
Croatian: Ispitivanju 1005, prilagođena geometrijska sredina Ctrough, ss krizotiniba u skupinama s blagim (N=191) i umjerenim (N=65) oštećenjem funkcije bubrega bila je 9,1% odnosno 15% viša nego u bolesnika s normalnom funkcijom bubrega.
English: Visual effects
Croatian: Učinci na vid
English: Based on the National Cancer Institute (NCI) classification, no starting dose adjustment of crizotinib is recommended for patients with mild hepatic impairment (either AST > Upper Limit of Normal (ULN) and total bilirubin ≤ULN or any AST and total bilirubin >ULN but 1.5 × ULN).
Croatian: National Cancer Institute, NCI) ne preporučuje se prilagodba početne doze krizotiniba u bolesnika s blagim oštećenjem jetre (AST > gornje granice normale (GGN) i vrijednost ukupnog bilirubina ≤ GGN, ili bilo koja vrijednost AST-a i vrijednost ukupnog bilirubina > GGN, ali ≤ 1,5 × GGN).
English: diltiazem used to treat heart problems.
Croatian: verapamilom, diltiazemom - koriste se za liječenje srčanih tegoba.
English: Dosing interruption, dose reduction, or discontinuation should be considered as appropriate if such symptoms are observed.
Croatian: U slučaju da se primijete takvi simptomi, treba razmotriti privremeni prekid doziranja, smanjenje doze ili trajni prekid liječenja, ovisno o tome što je prikladno.
English: Of 172 ALK-positive patients treated with crizotinib in randomised Phase 3 Study 1007, 27 (16%) were 65 years or older.
Croatian: Od 172 ALK-pozitivnih bolesnika liječenih krizotinibom u randomiziranom Ispitivanju 1007 faze 3, 27 (16%) ih je imalo 65 ili više godina.
English: For patients with previously treated baseline brain metastases, the median intracranial time to progression (IC-TTP) was 15.7 months in the crizotinib arm (N=39) and 12.5 months in the chemotherapy arm (N=40) (HR=0.45 [95% CI: 0.19, 1.07]; 1-sided p-value=0.0315).
Croatian: Za bolesnike s prethodno liječenim metastazama na mozgu na početku ispitivanja, medijan intrakranijalnog vremena do progresije bolesti (IC-TTP) bio je 15,7 mjeseci u skupini krizotiniba (N=39) i 12,5 mjeseci u kemoterapijskoj skupini (N=40) (HR=0,45 [95% CI: 0,19; 1,07]; 1-strana pvrijednost=0,0315).
English: In clinical studies with crizotinib and during post marketing surveillance, severe, life-threatening, or fatal adverse reactions of cardiac failure were reported (see section 4.8).
Croatian: U kliničkim ispitivanjima s krizotinibom i tijekom nadzora nakon stavljanja lijeka u promet zabilježene su teške, po život opasne ili smrtonosne nuspojave zatajenja srca (vidjeti dio 4.8).
English: Median times to onset for diarrhoea and constipation were 13 and 17 days, respectively.
Croatian: Medijan vremena do nastupa proljeva i konstipacije bili su 13 odnosno 17 dana.
English: Capsule content: colloidal anhydrous silica, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate (Type A), magnesium stearate.
Croatian: Sadržaj kapsule: bezvodni koloidni silicijev dioksid, mikrokristalična celuloza, bezvodni kalcijev hidrogenfosfat, natrijev škroboglikolat (vrste A) i magnezijev stearat.
English: N=905e
Croatian: N=905
English: Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, dizziness, hypotension), vision disorder, or fatigue while taking XALKORI (see sections 4.2, 4.4 and 4.8).
Croatian: Prilikom upravljanja vozilima i rada sa strojevima potreban je oprez jer se u bolesnika koji uzimaju XALKORI mogu javiti simptomatska bradikardija (npr. sinkopa, omaglica, hipotenzija), poremećaji vida, ili umor (vidjeti dijelove 4.2, 4.4 i 4.8).
English: Treatment with crizotinib should be used with caution in patients with hepatic impairment (see Table 2 and sections 4.4, 4.8 and 5.2).
Croatian: Liječenje krizotinibom treba primjenjivati oprezno u bolesnika s oštećenjem funkcije jetre (vidjeti tablicu 2 i dijelove 4.4, 4.8 i 5.2).
English: The QT interval prolongation potential of crizotinib was assessed in patients with either ALK-positive or ROS1-positive NSCLC who received crizotinib 250 mg twice daily.
Croatian: Potencijal krizotiniba da produlji QT-interval ispitan je u bolesnika s ALK-pozitivnim ili ROS1pozitivnim NSCLC-om koji su primali krizotinib u dozi od 250 mg dvaput na dan.
English: XALKORI is an anticancer medicine containing the active substance crizotinib used to treat adults with a type of lung cancer called non-small cell lung cancer, that presents with a specific rearrangement or defect in either a gene called anaplastic lymphoma kinase (ALK) or a gene called ROS1.
Croatian: Koristi se za liječenje odraslih osoba s jednom vrstom raka pluća, koji se naziva rak pluća nemalih stanica, u kojemu je prisutno specifično razmještanje ili oštećenje gena koji se zove kinaza anaplastičnog limfoma (engl. anaplastic lymphoma kinase, ALK) ili gena zvanog ROS1.
English: • Lung inflammation
Croatian: • Upala pluća
English: Ophthalmological evaluation is recommended if vision disorder persists or worsens in severity (see section 4.8).
Croatian: Preporučuje se oftalmološki pregled ako poremećaj vida ne prolazi ili se pogoršava (vidjeti dio 4.8).
English: The concomitant use of crizotinib with CYP3A4 substrates with narrow therapeutic indices should be avoided (see section 4.5).
Croatian: Treba izbjegavati istodobnu primjenu krizotiniba sa supstratima CYP3A4 uske terapijske širine (vidjeti dio 4.5).
English: All upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were <20 msec.
Croatian: Sve gornje granice 90%-tnog CI za srednju vrijednost promjene dobivenu metodom najmanjih kvadrata u odnosu na početne vrijednosti QTcF-intervala u svim vremenskim točkama 1. dana 2. ciklusa bile su < 20 msek.
English: Unchanged crizotinib represented approximately 53% and 2.3% of the administered dose in faeces and urine, respectively.
Croatian: Nepromijenjen krizotinib činio je približno 53% primijenjene doze u fecesu, odnosno 2,3% primijenjene doze u mokraći.
English: Patients who develop symptomatic bradycardia should be managed as recommended in the Dose Modification and Warnings and Precautions sections (see sections 4.2, 4.4 and 4.5).
Croatian: Bolesnici kod kojih se razvije simptomatska bradikardija trebaju se liječiti u skladu s preporukama u dijelovima Prilagodba doze i Posebna upozorenja i mjere opreza pri uporabi (vidjeti dijelove 4.2 i 4.4 i 4.5).
English: The starting crizotinib dose for patients with severe hepatic impairment (any AST and total bilirubin >3 × ULN) is recommended to be 250 mg once daily (see section 5.2).
Croatian: Preporučuje se da početna doza krizotiniba u bolesnika s teškim oštećenjem jetre (bilo koja vrijednost AST-a i vrijednost ukupnog bilirubina > 3 × GGN) bude 250 mg jedanput na dan (vidjeti dio 5.2).
English: Patients could continue treatment beyond the time of RECIST-defined disease progression at the discretion of the investigator.
Croatian: Bolesnici su mogli nastaviti liječenje nakon vremena progresije bolesti definirane RECIST-om, prema odluci ispitivača.
English: An ophthalmology substudy using specific ophthalmic assessments at specified time points was conducted in 54 patients with NSCLC who received crizotinib 250 mg twice daily.
Croatian: Oftalmološko podispitivanje u kojem su korištene određene oftalmološke procjene u određenim vremenskim točkama provedeno je na 54 bolesnika s NSCLC-om, koji su primali krizotinib od 250 mg dvaput dnevno.
English: Across studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC, median time to onset of increased Grade 1 or 2 transaminases was 23 days.
Croatian: U ispitivanjima s krizotinibom u bolesnika bilo s ALK-pozitivnim ili ROS1-pozitivnim NSCLC-om, medijan vremena do nastupa povišenja transaminaza stupnja 1 ili 2 bio je 23 dana.
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are substrates of OCT1 or OCT2 (e.g., metformin, procainamide).
Croatian: Stoga krizotinib može imati potencijal povećati koncentracije u plazmi istodobno primijenjenih lijekova koji su supstrati OCT1 ili OCT2 (npr. metformin, prokainamid).
English: In Study 1001, the adjusted geometric mean of plasma Ctrough, ss in mild (N=35) and moderate (N=8) renal impairment patients were 5.1% and 11% higher, respectively, than those in patients with normal renal function.
Croatian: U Ispitivanju 1001, prilagođena geometrijska sredina Ctrough, ss u plazmi u bolesnika s blagim (N=35) i umjerenim (N=8) oštećenjem funkcije bubrega bila je 5,1% odnosno 11% viša nego u bolesnika s normalnom funkcijom bubrega.
English: Therefore, the concomitant use of crizotinib with medicinal products known to prolong QT interval or medicinal products able to induce Torsades de pointes (e.g., class IA [quinidine, disopyramide] or class III [e.g., amiodarone, sotalol, dofetilide, ibutilide], methadone, cisapride, moxifloxacine, antipsychotics, etc.) should be carefully considered.
Croatian: Stoga treba pažljivo razmotriti istodobnu primjenu krizotiniba s lijekovima koji produljuju QT-interval, odnosno lijekovima koji mogu izazvati torsades de pointes (npr. antiaritmici skupine IA [kinidin, dizopiramid] ili skupine III [amiodaron, sotalol, dofetilid, ibutilid], metadon, cisaprid, moksifloksacin, antipsihotici, itd.).
English: Based on an in vitro study, crizotinib is predicted to inhibit intestinal P-gp.
Croatian: Na temelju rezultata ispitivanja in vitro, pretpostavlja se da krizotinib inhibira P-gp u crijevima.
English: • St. John's wort (Hypericum perforatum), a herbal product used to treat depression.
Croatian: • gospina trava (Hypericum perforatum) - biljni lijek za liječenje depresije.
English: The data described below reflect exposure to XALKORI in 1669 patients with ALK-positive advanced NSCLC who participated in 2 randomised Phase 3 studies (Studies 1007 and 1014) and in 2 single-arm studies (Studies 1001 and 1005), and in 53 patients with ROS1-positive advanced NSCLC who participated in single-arm Study 1001, for a total of 1722 patients (see section 5.1).
Croatian: Podaci opisani u nastavku odražavaju izloženost lijeku XALKORI u 1669 bolesnika s ALKpozitivnim uznapredovalim NSCLC-om koji su sudjelovali u 2 randomizirana ispitivanja faze 3 (Ispitivanja 1007 i 1014) i u dva klinička ispitivanja s jednom skupinom bolesnika (Ispitivanja 1001 i 1005), te u 53 bolesnika s ROS1-pozitivnim uznapredovalim NSCLC-om koji su sudjelovali u Ispitivanju 1001 s jednom skupinom bolesnika, za ukupno 1722 bolesnika (vidjeti dio 5.1).
English: Objective Response Rate [% (95% CI)] Time to Tumour Response [median (range)] weeks Duration of Responseb [median (95% CI)] months Progression-Free Survivalb [median (95% CI)] months OSb [median (95% CI)] months
Croatian: Stopa objektivnog odgovora [% (95% CI)] Vrijeme do tumorskog odgovora [medijan (raspon)] u tjednima Trajanje odgovora b [medijan (95% CI)] u mjesecima Preživljenje bez progresije bolesti b [medijan (95% CI)] u mjesecima
English: Crizotinib resulted in symptoms benefit by significantly prolonging time to deterioration (median 4.5 months versus 1.4 months) in patients who reported symptoms of pain in chest, dyspnoea, or cough, compared to chemotherapy (HR 0.50; 95% CI: 0.37, 0.66; Hochberg adjusted log-rank p< 0.0001).
Croatian: Krizotinib je ostvario korist na simptome tako što je značajno produljio vrijeme do pogoršanja (medijan 4,5 mjeseci naspram 1,4 mjeseca) kod bolesnika koji su prijavili simptome boli u prsištu, dispneje ili kašlja, u usporedbi s kemoterapijom (omjer hazarda 0,50; 95% CI: 0,37; 0,66; log-rang prilagođen 2-strani prema Hochbergu p-vrijednost< 0,0001).
English: The concurrent use of strong CYP3A inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John's wort, should be avoided (see section 4.4).
Croatian: Treba izbjegavati istodobnu primjenu snažnih induktora CYP3A, uključujući, no ne ograničavajući se na karbamazepin, fenobarbital, fenitoin, rifampicin i gospinu travu (vidjeti dio 4.4).
English: Based on the population pharmacokinetic analysis of data from Studies 1001, 1005, and 1007, age has no effect on crizotinib pharmacokinetics (see sections 4.2 and 5.1).
Croatian: Na temelju populacijske farmakokinetičke analize podataka iz Ispitivanja 1001, 1005 i 1007, dob ne utječe na farmakokinetiku krizotiniba (vidjeti dijelove 4.2 i 5.1).
English: • Colchicine, used to treat gout.
Croatian: • kolhicinom - koristi se za liječenje gihta.
English: There are no data in pregnant women using crizotinib.
Croatian: Nema podataka o primjeni krizotiniba u trudnica.
English: In Study 1007, the median duration of study treatment was 48 weeks for patients in the crizotinib arm (N=172).
Croatian: medijan trajanja ispitivanja liječenja bio je 48 tjedana za bolesnike u skupini koja je primala krizotinib (N=172).
English: p-valueg Duration of Response Mediane, Months (95% CI)
Croatian: p-vrijednost Trajanje odgovora Medijan e, mjeseci (95% CI)
English: Table 3 presents adverse reactions reported in 1722 patients with either ALK-positive or ROS1-positive advanced NSCLC who received crizotinib across 2 randomised Phase 3 studies (1007 and 1014) and 2 single-arm clinical studies (1001 and 1005) (see section 5.1).
Croatian: U Tablici 3 prikazane su nuspojave prijavljene u 1722 bolesnika bilo s ALK-pozitivnim ili ROS1pozitivnim uznapredovalim NSCLC-om koji su primali krizotinib u 2 randomizirana klinička ispitivanja faze 3 (1007 i 1014) i 2 klinička ispitivanja s jednom skupinom bolesnika (1001 i 1005) (vidjeti dio 5.1).
English: How to store XALKORI
Croatian: Kako čuvati XALKORI
English: Crizotinib demonstrated concentration-dependent inhibition of the kinase activity of ALK, ROS1, and c-Met in biochemical assays and inhibited phosphorylation and modulated kinase-dependent phenotypes in cell-based assays.
Croatian: U biokemijskim je testovima krizotinib pokazao inhibiciju kinazne aktivnosti ALK, ROS1 i c-Met ovisno o koncentraciji, dok je u staničnim testovima inhibirao fosforilaciju i modulirao o kinazi ovisne fenotipove.
English: Acute renal failure (<1%) Renal failure
Croatian: akutno zatajenje bubrega (<1%) zatajenje bubrega
English: There was one ALK-positive patient >85 years old out of 154 patients in single-arm Study 1001 (see also section 4.2 and 5.2).
Croatian: Od 154 bolesnika u Ispitivanju 1001 s jednom skupinom bolesnika jedan je ALK-pozitivni bolesnik bio u dobi >85 godina (vidjeti također dijelove 4.2 i 5.2).
English: Of the 53 ROS1-positive NSCLC patients in single arm Study 1001, 15 (28%) were 65 years or older.
Croatian: Od 53 bolesnika s ROS1- pozitivnim NSCLC-om u Ispitivanju 1001 s jednom skupinom bolesnika, 15 (28%) je imalo 65 godina ili više.
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, presence of brain metastases and prior EGFR TKI therapy.
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, prisutnost moždanih metastaza i prethodno liječenje inhibitorom tirozin kinaze EGFR-a.
English: An adjustment of the dose of crizotinib is recommended when administering crizotinib to patients with severe renal impairment not requiring peritoneal dialysis or haemodialysis (see sections 4.2 and 4.4).
Croatian: Prilagodba doze krizotiniba se preporuča kod primjene krizotiniba u bolesnika sa teškim oštećenjem bubrega koje ne zahtijeva peritonealnu dijalizu ili hemodijalizu (vidjeti dijelove 4.2 i 4.4).
English: Study 1001
Croatian: U ispitivanju 1007,
English: Other potential causes of ILD/pneumonitis should be excluded, and crizotinib should be permanently discontinued in patients diagnosed with treatment-related ILD/pneumonitis (see sections 4.2 and 4.8).
Croatian: Treba isključiti druge moguće uzroke IBP-a/pneumonitisa, a primjena krizotiniba mora se trajno obustaviti ako se postavi dijagnoza IBP-a/pneumonitisa povezanog s liječenjem (vidjeti dijelove 4.2 i
English: How to take XALKORI
Croatian: Kako uzimati XALKORI
English: The demographic characteristics were 57% female; median age 55 years; baseline ECOG performance status of 0 or 1 (98%) or 2 (2%), 57% White and 40% Asian; 25% former smokers, and 75% never smokers.
Croatian: Demografske karakteristike bile su: 57% žene; medijan dobi 55 godina; početno opće stanje prema ECOG ljestvici 0 ili 1 (98%) ili 2 (2%), 57% bijelaca i 40% azijata; 25% bivših pušača i 75% osoba koje nisu nikada pušile.
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are substrates of OCT1 or OCT2 (see section 4.5).
Croatian: Stoga krizotinib može povećati koncentracije u plazmi istodobno primijenjenih lijekova koji su supstrati OCT1 ili OCT2 (vidjeti dio 4.5).
English: If dose reduction is necessary for patients treated with crizotinib 250 mg orally twice daily, then the dose of crizotinib should be reduced as below.
Croatian: Ako je u bolesnika liječenih krizotinibom od 250 mg primijenjenim peroralno dvaput na dan potrebno smanjiti dozu, tada dozu krizotiniba treba smanjivati kako slijedi:
English: Any Grade interstitial lung disease (ILD)/pneumonitis
Croatian: Intersticijska bolest pluća (IBP)/pneumonitis bilo kojeg stupnja
English: • Procainamide, used to treat cardiac arrhythmia.
Croatian: • prokainamidom - koristi se za liječenje srčane aritmije.
English: XALKORI treatment
Croatian: Liječenje lijekom XALKORI
English: Ophthalmological evaluation is recommended if vision disorder persists or worsens in severity (see sections 4.2 and 4.4).
Croatian: Preporučuje se napraviti oftalmološki pregled ako poremećaj vida ne prolazi ili se pogoršava (vidjeti dijelove 4.2 i 4.4).
English: f. Dizziness (Balance disorder, Dizziness, Dizziness postural, Presyncope).
Croatian: f. Omaglica (poremećaj ravnoteže, omaglica, posturalna omaglica, presinkopa).
English: The most frequent adverse reactions (≥3%, all-causality frequency) associated with dose reductions were elevated transaminases (4%) and neutropenia (3%).
Croatian: Najčešće nuspojave (≥3%, učestalost svih uzroka) povezane uz smanjenja doze bile su povišene transaminaze (4%) i neutropenija (3%).
English: The systemic crizotinib exposure parameters AUCdaily and Cmax in patients with severe hepatic impairment (N=6) receiving a crizotinib dose of 250 mg once daily were approximately 64.7% and 72.6%, respectively, of those from patients with normal hepatic function receiving a dose of 250 mg twice daily.
Croatian: U bolesnika s teškim oštećenjem jetre (N = 6), koji su primali krizotinib u dozi od 250 mg jedanput na dan, parametri sistemske izloženosti krizotinibu AUCdaily i Cmax iznosili su približno 64,7% odnosno 72,6% izloženosti u bolesnika s normalnom funkcijom jetre koji su primali dozu od 250 mg dvaput na dan.
English: Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC, QTcF (corrected QT by the Fridericia method) ≥500 msec was recorded in 34 (2.1%) of 1619 patients with at least 1 postbaseline ECG assessment and a maximum increase from baseline in QTcF ≥60 msec was observed in 79 (5.0%) of 1585 patients with a baseline and at least 1 postbaseline ECG assessment.
Croatian: U ispitivanjima u bolesnika bilo s ALK-pozitivnim ili ROS1-pozitivnim uznapredovalim NSCLC-om, zabilježen je QTcF (QT interval korigiran prema Fridericijevoj metodi) ≥500 msek u 34 (2,1%) od 1619 bolesnika s najmanje jednim EKG snimanjem nakon početka ispitivanja, a najveći porast u odnosu na početnu vrijednost QTcF za ≥60 msek opažen je u 79 (5,0%) od 1585 bolesnika s početnim i barem 1 EKG snimanjem nakon početka ispitivanja.
English: Of 154 and 1063 ALK-positive NSCLC patients in single arm studies 1001 and 1005, 22 (14%) and 173 (16%) were 65 years or older, respectively.
Croatian: Od 154 odnosno 1063 bolesnika s ALK-pozitivnim NSCLC-om u ispitivanjima 1001 odnosno 1005, s jednom skupinom bolesnika, 22 (14%) odnosno 173 (16%) ih je imalo 65 ili više godina.
English: Grapefruit or grapefruit juice should be avoided during treatment with crizotinib (see sections 4.2 and
Croatian: Grejp i sok od grejpa treba izbjegavati tijekom liječenja krizotinibom (vidjeti dijelove 4.2 i 4.5).
English: The active substance in XALKORI is crizotinib.
Croatian: Djelatna tvar u lijeku XALKORI je krizotinib.
English: If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, resume at reduced dosec upon recovery to Grade ≤1 or to heart rate 60 or above
Croatian: Ako ne utvrdite, ili ne obustavite istodobno davan lijek koji doprinosi bradikardiji, ili ako mu ne promijenite dozu, nastavite sa smanjenom dozom c do poboljšanja na stupanj ≤1 ili do 60 ili više otkucaja srca.
English: • Metformin, used to treat diabetes.
Croatian: • metforminom - koristi se za liječenje šećerne bolesti.
English: However, the systemic crizotinib exposure in patients with moderate hepatic impairment at the dose of 200 mg twice daily was comparable to that observed from patients with normal hepatic function at a dose of 250 mg twice daily, with geometric mean ratios for AUCdaily and Cmax of 114% and 109%, respectively.
Croatian: Međutim, sistemska izloženost krizotinibu u bolesnika s umjerenim oštećenjem jetre pri dozi od 200 mg dvaput na dan bila je usporediva s izloženošću zabilježenom u bolesnika s normalnom funkcijom jetre pri dozi od 250 mg dvaput na dan, uz omjere geometrijskih sredina za AUCdaily od 114%, odnosno za Cmax od 109%.
English: Figure 4.
Croatian: Slika 4.
English: These patients received a starting oral dose of 250 mg taken twice daily continuously.
Croatian: Ti su bolesnici kontinuirano primali početnu peroralnu dozu lijeka od 250 mg dvaput na dan.
English: XALKORI dose modification - haematological toxicitiesa,b CTCAEc Grade
Croatian: Tablica 1: Prilagodba doze lijeka XALKORI - hematološka toksičnost a,b
English: • Closed pouches of fluid within the kidneys (kidney cysts).
Croatian: • zatvorene vrećice ispunjene tekućinom u bubrezima (bubrežne ciste).
English: Withhold until recovery to Grade ≤2, then resume at the next lower dosed,e a. Except lymphopenia (unless associated with clinical events, e.g., opportunistic infections).
Croatian: Isključujući limfopeniju (osim ako nije povezana s kliničkim događajima, npr. oportunističke infekcije).
English: Local cystic invasion beyond the kidney was observed in some patients.
Croatian: U nekih bolesnika opažena je lokalna invazija cisti izvan bubrega.