FrancophonIA/ELRC3.0 huggingface dataset:
English: Details for monitoring, dose adjustment and discontinuation are provided in Table 2.
Croatian: Detalji o praćenju, prilagodbi doze i prekidu liječenja navedeni su u Tablici
English: Lenvatinib and its metabolites are excreted in rat milk (see section 5.3).
Croatian: Lenvatinib i njegovi metaboliti izlučuju se u mlijeko štakora (vidjeti dio 5.3).
English: The recommended daily dose of lenvatinib is 24 mg (two 10 mg capsules and one 4 mg capsule) once daily.
Croatian: Preporučena dnevna doza lenvatiniba je 24 mg (dvije kapsule od 10 mg i jedna kapsula od 4 mg) jedanput dnevno.
English: Mortality was the dose-limiting toxicity in juvenile rats in which dosing was initiated on postnatal day (PND) 7 or PND21 and was observed at exposures that were respectively 125- or 12-fold lower compared with the exposure at which mortality was observed in adult rats, suggesting an increasing sensitivity to toxicity with decreasing age.
Croatian: Mortalitet je bila toksičnost koja je ograničavala dozu u mladih štakora u kojih je doziranje započelo 7. ili 21. postnatalnog dana i bio je opažen pri izloženostima 125 ili 12 puta manjim u usporedbi s izloženošću pri kojoj je mortalitet bio opažen u odraslih štakora, što ukazuje na to da je osjetljivost na toksičnost to veća što je dob manja.
English: • dry, sore, or inflamed mouth, odd taste sensation
Croatian: • suha, bolna ili upaljena usta, promjena osjeta okusa
English: Hepatic encephalopathy (including fatal events in 4 patients) occurred in 8.4% of patients (5.5% were ≥ Grade 3).
Croatian: Hepatička encefalopatija (uključujući fatalne slučajeve u 4 bolesnika) javila se u 8,4% bolesnika (5,5% bili su ≥3.stupnja).
English: The median time to onset was 6.1 weeks.
Croatian: Medijan vremena do pojave bio je 6,1 tjedana.
English: Administration of lenvatinib during organogenesis resulted in embryolethality and teratogenicity in rats (foetal external and skeletal anomalies) at exposures below the clinical exposure (based on AUC) at the maximum tolerated human dose, and rabbits (foetal external, visceral or skeletal anomalies) based on body surface area; mg/m2 at the maximum tolerated human dose.
Croatian: Primjena lenvatiniba tijekom organogeneze rezultirala je embrioletalnim i teratogenim učincima kod štakora (vanjske i skeletne anomalije u fetusa) pri izloženostima manjim od kliničke izloženosti (na temelju AUC-a) pri maksimalnoj podnošljivoj dozi za ljude, a u kunića (vanjske, visceralne i skeletne anomalije u fetusa) na temelju površine tijela; mg/m2 pri maksimalnoj podnošljivoj dozi za ljude.
English: • changes in blood test results for magnesium (low), cholesterol (high) and thyroid stimulating hormone (high)
Croatian: • promjene u nalazima krvnih pretraga za magnezij u krvi (sniženi), kolesterol (povišen) i hormon koji stimulira štitnjaču (povišen)
English: The main metabolic pathways in humans were identified as oxidation by aldehyde oxidase, demethylation via CYP3A4, glutathione conjugation with elimination of the O-aryl group (chlorophenyl moiety), and combinations of these pathways followed by further biotransformations (e.g., glucuronidation, hydrolysis of the glutathione moiety, degradation of the cysteine moiety, and intramolecular rearrangement of the cysteinylglycine and cysteine conjugates with subsequent dimerisation).
Croatian: Kao glavni metabolički putevi u ljudi, utvrđene su oksidacija aldehid oksidazom, demetilacija putem CYP3A4, konjugacija s glutationom uz eliminaciju O-arilne skupine (klorfenilni dio) i kombinacija ovih puteva nakon čega slijedi daljnja biotransformacija (npr. glukuronidacija, hidroliza glutationskog dijela, razgradnja cisteinskog dijela i intramolekularno premještanje cisteinilglicina i konjugata cisteina daljnjom dimerizacijom).
English: The median time to onset of hepatotoxocity adverse reactions was 6.4 weeks.
Croatian: Medijan vremena do pojave nuspojava hepatotoksičnosti bio je 6,4 tjedana.
English: may be restarted once adequate wound healing is established.
Croatian: LENVIMA se može nastaviti primati kada se utvrdi odgovarajuće cijeljenje rana.
English: Hepatic failure (including fatal events in 12 patients) occurred in 3.6% of patients (all were ≥ Grade 3).
Croatian: Zatajenje jetre (uključujući fatalne slučajeve u 12 bolesnika) javilo se u 3,6% bolesnika (svi su bili ≥3.stupnja).
English: 15.1 (8.8, NE)
Croatian: 15,1 (8,8, NP)
English: • chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, feeling very tired - these may be signs of a heart problem, a blood clot in your lung or a leak of air from your lung into your chest so your lung cannot inflate.
Croatian: • bol ili pritisak u prsnom košu, bol u rukama, leđima, vratu ili čeljusti, nedostatak zraka, ubrzan ili nepravilan puls, kašalj, plavičasta boja usana ili prstiju, osjećaj velikog umora - to mogu biti znakovi tegoba sa srcem, krvnog ugruška u plućima ili prodiranja zraka iz plućnog krila u prsni koš, zbog čega se pluća ne mogu napuhati
English: Hepatic encephalopathy includes: hepatic encephalopathy, coma hepatic, metabolic encephalopathy and encephalopathy.
Croatian: Hepatička encefalopatija uključuje: hepatičku encefalopatiju, hepatičku komu, metaboličku encefalopatiju i encefalopatiju.
English: The toxicity of lenvatinib was more prominent in younger rats (dosing initiated on PND7) compared with those with dosing initiated on PND21 and mortality and some toxicities were observed earlier in the juvenile rats at 10 mg/kg compared with adult rats administered the same dose level.
Croatian: Toksičnost lenvatiniba bila je izraženija u mlađih štakora (doziranje započeto 7. postnatalnog dana) u usporedbi s onima u kojih je doziranje započelo 21. postnatalnog dana i mortalitet i neke toksičnosti bile su ranije opažene u mladih štakora pri 10 mg/kg u usporedbi s odraslim štakorima kojima se primijenila ista razina doze.
English: Increased blood alkaline phosphatase Hepatic function abnormal Increased gammaglutamyltransferase Cholecystitis
Croatian: povišena alkalna fosfataza u krvi abnormalna funkcija jetre povišena gamaglutamil transferaza kolecistitis hepatocelularno oštećenje/hepatitism
English: • hoarse voice
Croatian: • hrapav glas
English: The main efficacy outcome measure was progression-free survival (PFS) as determined by blinded independent radiologic review using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Croatian: Glavna mjera ishoda za djelotvornost bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS) utvrđeno slijepim neovisnim radiološkim pregledom prema Kriterijima za procjenu terapijskog odgovora kod solidnih tumora (engl.
English: Temporary interruption of lenvatinib should be considered in patients undergoing major surgical procedures.
Croatian: Treba razmotriti privremeni prekid davanja lenvatiniba u bolesnika kod kojih se izvode veliki kirurški zahvati.
English: • you are breast-feeding (see the section below on Contraception, pregnancy and breast-feeding).
Croatian: • ako dojite (pogledajte niže dio o kontracepciji, trudnoći i dojenju).
English: In DTC, liver-related adverse reactions most commonly reported in patients treated with lenvatinib included increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and blood bilirubin.
Croatian: Kod DTC-a, nuspojave povezane s jetrom koje su najčešće bile zabilježene u bolesnika liječenih lenvatinibom, uključivale su povišenje alanin aminotransferaze (ALT), aspartat aminotransferaze (AST) i bilirubina u krvi.
English: Number of objective responders (%) (95% CI)
Croatian: Broj bolesnika s objektivnim odgovorom (%) (95% CI)
English: Women of childbearing potential should avoid becoming pregnant and use highly effective contraception while on treatment with lenvatinib and for at least one month after finishing treatment.
Croatian: Žene reproduktivne dobi trebaju izbjegavati trudnoću i koristiti visokoučinkovitu kontracepciju za vrijeme liječenja lenvatinibom i još najmanje mjesec dana nakon završetka liječenja.
English: Proteinuria led to permanent treatment discontinuation in 0.6% of patients.
Croatian: Proteinurija je dovela do trajnog prekida liječenja u 0,6% bolesnika.
English: Hyperbilirubinaeamia includes: hyperbilirubinaemia, increased blood bilirubin, jaundice and increased bilirubin conjugated.
Croatian: Hiperbilirubinemija uključuje: hiperbilirubinemiju, povišen bilirubin u krvi, žuticu i povišeni konjugirani bilirubin.
English: However, testicular (hypocellularity of the seminiferous epithelium) and ovarian changes (follicular atresia) were observed in repeated-dose toxicity studies in animals at exposures 11 to 15 times (rat) or 0.6 to 7 times (monkey) the anticipated clinical exposure (based on AUC) at the maximum tolerated human dose.
Croatian: Međutim, u ispitivanjima toksičnosti ponovljenih doza na životinjama bile su opažene promjene na testisima (hipocelularnost sjemenskog epitela) i jajnicima (folikularna atrezija) pri izloženostima 11 do 15 puta (štakor) ili 0,6 do 7 puta (majmun) većim od očekivane kliničke izloženosti (na temelju AUC-a) kod maksimalne podnošljive doze za ljude.
English: However, testicular and ovarian toxicity has been observed in rats, dogs, and monkeys (see section 5.3).
Croatian: Međutim, u štakora, pasa i majmuna opažena je testikularna i ovarijalna toksičnost (vidjeti dio 5.3).
English: Discontinue lenvatinib and institute appropriate medical management.
Croatian: Trajno prekinite primjenu lenvatiniba i započnite s odgovarajućim medicinskim liječenjem.
English: Amongst 1,823 patients treated with lenvatinib monotherapy in clinical studies, there were 10 cases (0.5%) of arterial thromboembolisms (5 cases of myocardial infarction and 5 cases of cerebrovascular accident) with a fatal outcome.
Croatian: Među 1823 bolesnika liječenih monoterapijom lenvatiniba u kliničkim ispitivanjima, bilo je 10 slučajeva (0,5%) arterijske tromboembolije (5 slučajeva infarkta miokarda i 5 slučajeva cerebrovaskularnog inzulta) sa smrtnim ishodom.
English: P-valueb
Croatian: P-vrijednostb
English: Hepatotoxicity reactions of ≥ Grade 3 occurred in 26.1% of lenvatinib-treated patients.
Croatian: Nuspojave hepatotoksičnosti ≥3.stupnja javile su se u 26,1% bolesnika liječenih lenvatinibom.
English: LENVIMA is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
Croatian: LENVIMA je indicirana kao monoterapija za liječenje odraslih bolesnika s progresivnim, lokalno uznapredovalim ili metastatskim diferenciranim (papilarnim/folikularnim/Hürthleovih stanica) karcinomom štitnjače, refraktornim na radioaktivni jod (RAI).
English: BP should be monitored after 1 week of treatment with lenvatinib, then every 2 weeks for the first 2 months, and monthly thereafter.
Croatian: Krvni tlak treba pratiti nakon jednog tjedna liječenja lenvatinibom, zatim svaka 2 tjedna tijekom prva 2 mjeseca, a nakon toga svakog mjeseca.
English: The majority of patients had an ECOG performance status of 0; 42.1% had a status of 1; 3.9% had a status above 1.
Croatian: Eastern Cooperative Oncology Group) bilo je ocijenjeno s 0; 42,1% imalo je ocjenu 1; 3,9% imalo je ocjenu iznad 1.
English: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal antihypertensive therapy
Croatian: Sistolički krvni tlak ≥160 mmHg ili dijastolički krvni tlak ≥100 mmHg usprkos optimalnoj antihipertenzivnoj terapiji
English: Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS) (see section 4.4)
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES) / sindrom reverzibilne posteriorne leukoencefalopatije (RPLS) (vidjeti dio 4.4)
English: In post-marketing surveillance, serious and fatal carotid artery haemorrhages were seen more frequently in patients with anaplastic thyroid carcinoma (ATC) than in DTC or other tumour types.
Croatian: Tijekom praćenja nakon stavljanja lijeka u promet, ozbiljna i smrtonosna krvarenja karotidne arterije opažena su češće u bolesnika s anaplastičnim karcinomom štitnjače nego s diferenciranim karcinomom štitnjače ili drugim vrstama tumora.
English: Blood pressure should be well controlled prior to treatment with lenvatinib, and should be regularly monitored during treatment (see section 4.4).
Croatian: Prije početka liječenja lenvatinibom krvni tlak mora biti dobro kontroliran, a tijekom liječenja mora se redovito pratiti (vidjeti dio 4.4).
English: One subject (0.2%) discontinued lenvatinib due to hypertension.
Croatian: Jedan ispitanik (0,2%) trajno je prekinuo liječenje zbog hipertenzije.
English: Gastrointestinal and abdominal pain includes: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, epigastric discomfort, and gastrointestinal pain.
Croatian: Gastrointestinalni i abdominalni bol uključuje: abdominalnu nelagodu, abdominalni bol, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena, abdominalnu osjetljivost, nelagodu u epigastriju i gastrointestinalni bol.
English: Hypocalcaemia (see section 4.4, QT interval prolongation)
Croatian: Hipokalcemija (vidjeti dio 4.4, Produljenje QT intervala)
English: Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule.
Croatian: Osobe koje skrbe o bolesniku ne smiju otvarati kapsulu, kako bi izbjegle ponavljano izlaganje sadržaju kapsule.
English: • low levels of platelets in the blood which may lead to bruising and difficulty in wound healing
Croatian: • sniženi broj krvnih pločica što može dovesti do nastanka modrica i otežanog cijeljenja rana
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1002/001 (Pack size of 30 hard capsules) EU/1/15/1002/003 (Pack size of 60 hard capsules) EU/1/15/1002/004 (Pack size of 90 hard capsules) 13.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1002/001 (veličina pakiranja od 30 tvrdih kapsula) EU/1/15/1002/003 (veličina pakiranja od 60 tvrdih kapsula) EU/1/15/1002/004 (veličina pakiranja od 90 tvrdih kapsula) 13. BROJ SERIJE
English: Lenvatinib displays minimimal accumulation at steady state.
Croatian: Lenvatinib se minimalno nakuplja u stanju dinamičke ravnoteže.
English: Subjects with end-stage renal disease were not studied.
Croatian: Ispitanici sa završnim stadijem bubrežne bolesti nisu bili ispitani.
English: Patients with low body weight (<60 kg) had a higher incidence of PPE, proteinuria, of Grade 3 or 4 hypocalcaemia and hyponatraemia, and a trend towards a higher incidence of Grade 3 or 4 decreased appetite.
Croatian: Bolesnici s niskom tjelesnom težinom (<60 kg) imali su višu incidenciju PPE-a, proteinurije, 3. ili 4. stupnja hipokalcemije i hiponatremije te sklonost prema višoj incidenciji smanjenog apetita 3. ili 4. stupnja.
English: The pharmacokinetics of lenvatinib following a single 24-mg dose were evaluated in 6 subjects each with mild, moderate, and severe renal impairment, and compared with 8 healthy, demographically matched subjects.
Croatian: Farmakokinetika lenvatiniba nakon jedne doze od 24 mg bila je procijenjena u 6 ispitanika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega u usporedbi s 8 zdravih ispitanika sličnih demografskih karakteristika.
English: The median duration of objective response was 7.3 (95% CI 5.6, 7.4) months in the lenvatinib arm and 6.2 (95% CI 3.7, 11.2) months in the sorafenib arm.
Croatian: Medijan trajanja objektivnog odgovora bilo je 7,3 (95% CI 5,6; 7,4) mjeseci u skupini na lenvatinibu i 6,2 (95% CI 3,7; 11,2) mjeseci u skupini na sorafenibu.
English: Serious tumour related bleeds, including fatal haemorrhagic events have occurred in clinical trials and have been reported in post-marketing experience (see section 4.8, Description of selected adverse reactions).
Croatian: Ozbiljna krvarenja povezana s tumorom, uključujući hemoragijske događaje sa smrtnim ishodom, dogodila su se u kliničkim ispitivanjima, a zabilježena su i poslije stavljanja lijeka u promet (vidjeti dio 4.8, Opis odabranih nuspojava).
English: Lenvatinib should be discontinued following an arterial thrombotic event.
Croatian: Primjenu lenvatiniba treba trajno prekinuti nakon pojave događaja arterijske tromboze.
English: Females had a higher incidence of hypertension (including Grade 3 or 4 hypertension), proteinuria, and PPE, while males had a higher incidence of decreased ejection fraction and gastrointestinal perforation and fistula formation.
Croatian: Žene su imale višu incidenciju hipertenzije (uključujući hipertenziju 3. ili 4. stupnja), proteinurije i PPE-a, dok su muškarci imali višu incidenciju smanjene ejekcijske frakcije i gastrointestinalne perforacije te stvaranja fistule.
English: There is limited clinical experience regarding the timing of reinitiation of lenvatinib following a major surgical procedure.
Croatian: Kliničko iskustvo u pogledu primjerenog vremena ponovnog početka davanja lenvatiniba nakon velikih kirurških zahvata je ograničeno.
English: Mild to moderate adverse reactions (e.g., Grade 1 or 2) generally do not warrant interruption of lenvatinib, unless intolerable to the patient despite optimal management.
Croatian: Blage do umjerene nuspojave (npr. 1. ili 2. stupnja) općenito ne zahtijevaju privremeni prekid primjene lenvatiniba, osim ako su bolesniku nepodnošljive unatoč optimalnom zbrinjavanju.
English: Lenvatinib showed minimal or no inhibitory activities toward P-gp-mediated and breast cancer resistance protein (BCRP)-mediated transport activities.
Croatian: Pokazalo se da lenvatinib minimalno djeluje ili uopće ne djeluje inhibicijski na transportne aktivnosti posredovane P-gp-om i proteinom rezistencije raka dojke (BCRP).
English: • redness, soreness and swelling of the skin on the hands and feet (hand-foot syndrome)
Croatian: • crvenilo, bolno na dodir i oticanje kože na šakama i stopalima (sindrom šaka-stopalo)
English: No adjustment of starting dose is required on the basis of hepatic function in patients with mild (ChildPugh A) or moderate (Child-Pugh B) hepatic impairment.
Croatian: Nije potrebna prilagodba početne doze na temelju funkcije jetre u bolesnika s blagim (Child-Pugh A) ili umjerenim (Child-Pugh B) oštećenjem funkcije jetre.
English: Amongst 1,166 patients treated with lenvatinib, there were 3 cases (0.3%) of hepatic failure, all with a fatal outcome.
Croatian: Među 1166 bolesnika liječenih lenvatinibom bila su 3 slučaja (0,3%) zatajenja jetre, svi sa smrtnim ishodom.
English: Cases of nephrotic syndrome have been reported in patients using lenvatinib.
Croatian: Slučajevi nefrotskog sindroma zabilježeni su u bolesnika koji su uzimali lenvatinib.
English: Elevation of TSH above the upper limit of normal was observed post baseline in 69.6% of lenvatinib-treated patients.
Croatian: Porast TSH-a iznad gornje granice normale zapažen je nakon početka ispitivanja u 69,6% bolesnika liječenih lenvatinibom.
English: EU/1/15/1002/002 (Pack size of 30 hard capsules) EU/1/15/1002/005 (Pack size of 60 hard capsules) EU/1/15/1002/006 (Pack size of 90 hard capsules)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1002/002 (veličina pakiranja od 30 tvrdih kapsula) EU/1/15/1002/005 (veličina pakiranja od 60 tvrdih kapsula) EU/1/15/1002/006 (veličina pakiranja od 90 tvrdih kapsula) 13. BROJ SERIJE
English: It is currently unknown whether lenvatinib may reduce the effectiveness of hormonal contraceptives, and therefore women using oral hormonal contraceptives should add a barrier method.
Croatian: Trenutno nije poznato može li lenvatinib smanjiti učinkovitost hormonskih kontraceptiva pa stoga žene koje koriste oralnu hormonsku kontracepciju trebaju dodatno koristiti i mehaničku metodu.
English: • An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Croatian: • proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije).
English: Across clinical studies in which 1327 patients received lenvatinib monotherapy in indications other than HCC, hepatic failure (including fatal events) was reported in 4 patients (0.3%), liver injury in 2 patients (0.2%), acute hepatitis in 2 patients (0.2%), and hepatocellular injury in 1 patient (0.1%).
Croatian: U kliničkim ispitivanjima u kojima je 1327 bolesnika primilo monoterapiju lenvatiniba u indikacijama osim HCC-a, zatajenje jetre (uključujući fatalne slučajeve) prijavljeno je u 4 bolesnika (0,3%), oštećenje jetre u 2 bolesnika (0,2%), akutni hepatitis u 2 bolesnika (0,2%), a hepatocelularno oštećenje u 1 bolesnika (0,1%).
English: In those patients with a normal TSH at baseline, elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of lenvatinib-treated patients as compared with 14% of placebo-treated patients.
Croatian: U tih bolesnika s normalnim TSH-om na početku, povišenje razine TSH iznad 0,5 mU/l bilo je opaženo nakon početka ispitivanja u 57% bolesnika liječenih lenvatinibom u usporedbi s 14% bolesnika koji su primali placebo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION LENVIMA 4 mg hard capsules
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV LENVIMA 4 mg tvrde kapsule
English: Hypoalbuminaemia includes hypoalbuminaemia and decreased blood albumin.
Croatian: Hipoalbuminemija uključuje hipoalbuminemiju i snižen albumin u krvi.
English: In the patient populations enrolled in the HCC study no dose adjustments were required on the basis of hepatic function in those patients who had mild hepatic impairment (Child-Pugh A).
Croatian: U populaciji bolesnika uključenih u HCC ispitivanje, nije bilo potrebno prilagođavanje doze na temelju funkcije jetre u bolesnika koji su imali blago oštećenje funkcije jetre (Child-Pugh A).
English: No differences between lenvatinib- and placebo-treated patients were observed in the incidences of serious reactions (3.4% vs. 3.8%), reactions leading to premature discontinuation (1.1% vs. 1.5%), or reactions leading to dose interruption (3.4% vs. 3.8%) or reduction (0.4% vs. 0).
Croatian: Nisu opažene razlike između bolesnika liječenih lenvatinibom i onih koji su primali placebo u incidenciji ozbiljnih nuspojava (3,4% naspram 3,8%), nuspojava koje su dovele do preuranjenog prestanka liječenja (1,1% naspram 1,5%) ili nuspojava koje su dovele do privremenog prekida primjene (3,4% naspram 3,8%) ili sniženja doze (0,4% naspram 0).
English: Efficacy Results from the REFLECT study in HCC Efficacy parameter
Croatian: Tablica 7: Rezultati djelotvornosti kod HCC-a u ispitivanju REFLECT
English: How to take LENVIMA
Croatian: Kako uzimati LENVIMU
English: Patients with worse hepatic impairment and/or greater liver tumour burden at baseline had a higher risk of developing hepatic encephalopathy and hepatic failure.
Croatian: Bolesnici s težim oštećenjem funkcije jetre i/ili veći opterećenjem tumorom jetre na početku liječenja imali su povećani rizik od pojave hepatičke encefalopatije i zatajenja jetre.
English: 18.3 (15.1, NE)
Croatian: 18,3 (15,1, NP)
English: In total, 954 patients were randomised 1:1 to receive either lenvatinib (12 mg [baseline body weight ≥60 kg] or 8 mg [baseline body weight <60 kg]) given orally once daily or sorafenib 400 mg given orally twice daily.
Croatian: Ukupno je 954 bolesnika randomizirano 1:1 za primanje lenvatiniba (12 mg [početna tjelesna težina ≥60 kg] ili 8 mg [početna tjelesna težina <60 kg]) primijenjenog peroralno jedanput dnevno ili sorafeniba 400 mg primijenjenog peroralno dvaput dnevno.
English: Some reports of fistula and pneumothorax occurred in association with tumour regression or necrosis.
Croatian: Neki slučajevi fistule i pneumotoraksa pojavili su se povezano s regresijom ili nekrozom tumora.
English: It is not known whether lenvatinib is excreted in human milk.
Croatian: Nije poznato izlučuje li se lenvatinib u majčino mlijeko.