FrancophonIA/ELRC3.0 huggingface dataset:
English: In subgroup analyses by stratification factors (presence or absence of MPVI or EHS or both, ECOG PS 0 or 1, BW <60 kg or ≥60 kg and region) the HR consistently favoured lenvatinib over sorafenib, with the exception of Western region [HR of 1.08 (95% CI 0.82, 1.42], patients without EHS [HR of 1.01 (95% CI 0.78, 1.30)] and patients without MPVI, EHS or both [HR of 1.05 (0.79, 1.40)].
Slovenian: Pri analizah podskupin po faktorjih stratifikacije (prisotnost ali odsotnost MPVI ali EHS ali obeh, ECOG PS 0 ali 1, TM < 60 kg ali ≥ 60 kg in regija) je bila vrednost HR dosledno boljša za lenvatinib kot za sorafenib, razen v zahodni regiji [HR 1,08 (95-odstotni IZ 0,82; 1,42), pri bolnikih brez EHS [HR 1,01 (95-odstotni IZ 0,78; 1,30)] in pri bolnikih brez MPVI, EHS ali obeh [HR 1,05 (0,79; 1,40)].
English: Continue lenvatinib and initiate antihypertensive therapy, if not already receiving
Slovenian: Nadaljujte z lenvatinibom in začnite z antihipertenzivnim zdravljenjem, če ga bolnik še ne prejema.
English: Lenvatinib is rapidly absorbed after oral administration with tmax typically observed from 1 to 4 hours postdose.
Slovenian: Lenvatinib se po peroralnem dajanju hitro absorbira, tmax je navadno od 1 do 4 ure po odmerku.
English: • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0: 63%, ECOG PS of
Slovenian: • stanje po lestvici ECOG PS 0: 63 %, ECOG PS 1: 37 %,
English: In the repeated-dose toxicity studies (up to 39 weeks), lenvatinib caused toxicologic changes in various organs and tissues related to the expected pharmacologic effects of lenvatinib including glomerulopathy, testicular hypocellularity, ovarian follicular atresia, gastrointestinal changes, bone changes, changes to the adrenals (rats and dogs), and arterial (arterial fibrinoid necrosis, medial degeneration, or haemorrhage) lesions in rats, dogs, and cynomolgus monkeys.
Slovenian: V študijah toksičnosti ponavljajočih se odmerkov (do 39 tednov) je lenvatinib povzročal toksikološke spremembe v različnih organih in tkivih, ki so bile povezane s pričakovanimi farmakološkimi učinki lenvatiniba, vključno z glomerulopatijo, testikularno hipocelularnostjo, atrezijo ovarijskih foliklov, spremembami prebavil, spremembami kosti, spremembami nadledvičnic (pri podganah in psih) in arterijskimi (arterijska fibrinoidna nekroza, degeneracija medije ali krvavitev) lezijami pri podganah, psih in opicah Cynomolgus.
English: The median time to objective responsive was 2.0 (95% CI: 1.9, 3.5) months; however, of the patients who experienced a complete or partial response to lenvatinib, 70.4% were observed to develop the response on or within 30 days of being on the 24-mg dose.
Slovenian: Mediani čas do objektivnega odziva je bil 2,0 meseca (95 % IZ: 1,9; 3,5); vendar so opazili, da je od bolnikov, ki so imeli popoln ali delen odziv na lenvatinib, 70,4 % razvilo odziv v 30 dneh prejemanja 24-miligramskega odmerka ali prej.
English: European Knowledge Centre, Mosquito Way, Hatfield, Herfordshire, AL10 9SN, United Kingdom Or
Slovenian: Eisai Manufacturing Ltd European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Velika Britanija
English: Recommended daily dose
Slovenian: Priporočeni dnevni odmerek
English: Histologically, 66.1% had a confirmed diagnosis of papillary thyroid cancer and 33.9% had follicular thyroid cancer which included Hürthle cell 14.8% and clear cell 3.8%.
Slovenian: Histološko jih je imelo 66,1 % potrjeno diagnozo papilarnega raka ščitnice, 33,9 % pa diagnozo folikularnega raka ščitnice, ki je vključeval raka Hürthleovih celic (14,8 %) in svetlih celic (3,8 %).
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.
Slovenian: • bolečina ali stiskanje v prsih, bolečina v zgornjih udih, hrbtu, vratu ali čeljusti, kratka sapa, hiter ali nereden srčni utrip, kašelj, modrikasta barva ustnic ali prstov, občutek močne utrujenosti - to so lahko znaki težav s srcem, krvnega strdka v vaših pljučih ali uhajanja zraka iz pljuč v prsni koš, tako da se pljuča ne morejo napihniti;
English: The dose is usually 12 mg once a day (3 capsules of 4 mg) if you weigh 60 kg or more and 8 mg once a day (2 capsules of 4 mg) if you weigh less than 60kg.
Slovenian: Odmerek navadno 12 mg enkrat na dan (3 kapsule po 4 mg), če ste težki 60 kg ali več oz. 8 mg enkrat na dan (2 kapsuli po 4 mg), če ste težki manj kot 60 kg.
English: Reproductive and developmental toxicity
Slovenian: Vpliv na sposobnost razmnoževanja in razvoj
English: LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 5.1).
Slovenian: Zdravilo LENVIMA je indicirano kot monoterapija za zdravljenje odraslih bolnikov z napredovalim ali neoperabilnim heptocelularnim karcinomom (HCC - hepatocellular carcinoma), ki predhodno niso bili sistemsko zdravljeni (glejte poglavje 5.1)
English: Lenvatinib exposure, based on AUC0-inf data, was 101%, 90%, and 122% of normal for subjects with mild, moderate, and severe renal impairment, respectively.
Slovenian: Izpostavljenost lenvatinibu na podlagi podatkov AUC0-inf je bila 101 %, 90 % oziroma 122 % normalne vrednosti pri preiskovancih z blago, zmerno oziroma hudo okvaro ledvic.
English: What LENVIMA looks like and contents of the pack
Slovenian: Izgled zdravila LENVIMA in vsebina pakiranja
English: • changes in blood test results for liver function
Slovenian: • sprememba rezultatov krvnih preiskav za delovanje jeter,
English: (1 capsule of 10 mg and 1 capsule of 4 mg).
Slovenian: (1 kapsula z 10 mg in 1 kapsula s 4 mg).
English: 4.5 Interaction with other medicinal products and other forms of interaction Effect of other medicinal products on lenvatinib
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormality judged to be non-life-threatening, in which case they should be managed as severe reaction (e.g., Grade 3).
Slovenian: Zdravljenje je treba prekiniti v primeru življenjsko nevarnih neželenih učinkov (npr. stopnje 4), z izjemo laboratorijskih nenormalnosti, za katere sodimo, da niso življenjsko nevarne; v tem primeru jih obravnavajte kot hude neželene učinke (npr.stopnje 3).
English: The incidence of QT interval prolongation of greater than 500 ms was 2% in the lenvatinib-treated patients compared to no reports in the placebo group.
Slovenian: Pogostnost podaljšanja intervala QT, večjega od 500 ms, je bila 2 % pri bolnikih, zdravljenih z lenvatinibom, v skupini s placebom pa o tem niso poročali.
English: Arterial thromboembolic events also occurred at an increased incidence in this age group.
Slovenian: V tej starostni skupini so se pogosteje pojavljali tudi arterijski tromboembolični dogodki.
English: Adjusted Doseb (≥60 kg BW)
Slovenian: Prilagojen odmerekb (≥ 60 kg TM)
English: All patients other than those with severe hepatic or renal impairment (see below) should initiate treatment at the recommended 24 mg dose, following which the dose should be further adjusted on the basis of individual tolerability.
Slovenian: Vsi bolniki razen tistih, ki imajo hudo okvaro jeter ali ledvic (glejte v nadaljevanju), naj začnejo z zdravljenjem s priporočenim odmerkom 24 mg, nato pa naj se odmerek nadalje prilagaja na podlagi prenašanja vsakega bolnika posebej.
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.
Slovenian: Dajanje lenvatiniba med organogenezo je povzročilo smrtnost zarodkov in teratogenost pri podganah (fetalne zunanje in skeletne anomalije) pri izpostavljenostih, manjših od klinične izpostavljenosti (na podlagi AUC) pri največjem toleriranem odmerku za človeka, in kuncih (fetalne zunanje, visceralne ali skeletne anomalije) na podlagi velikosti telesne površine; mg/m2 pri največjem toleriranem odmerku za človeka.
English: may be restarted once adequate wound healing is established.
Slovenian: Zdravilo LENVIMA se lahko ponovno uvede, ko je ugotovljeno ustrezno celjenje ran
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.
Slovenian: Bolniki s hujšo jetrno okvaro in/ali večjim bremenom tumorja jeter v izhodišču so imeli večje tveganje za razvoj jetrne encefalopatije in odpovedi jeter.
English: Table 5 Adverse reactions reported in patients treated with lenvatinib System Organ
Slovenian: Preglednica 5 Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z lenvatinibom Organski sistem (terminologija
English: For lenvatinib related toxicities (see Table 3), upon resolution/improvement of an adverse reaction to Grade 0-1 or baseline, treatment should be resumed at a reduced dose of lenvatinib as suggested in Table 1.
Slovenian: Pri toksičnostih, povezanih z lenvatinibom (glejte preglednico 3), naj se po tistem, ko neželeni učinek izzveni ali se izboljša na stopnjo 0-1 ali v izhodišče, zdravljenje spet začne z zmanjšanim odmerkom lenvatiniba v skladu s preglednico 1.
English: Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS) (see section 4.4)
Slovenian: Sindrom posteriorne reverzibilne encefalopatije (PRES) / sindrom reverzibilne posteriorne levkoencefalopatije (RPLS)(glejte poglavje 4.4)
English: Cardiac failure Prolonged electrocardiogram QT Decreased ejection fraction
Slovenian: popuščanje srca podaljšanje intervala QT v elektrokardiogramu zmanjšanje iztisne frakcije
English: Proteinuria led to permanent treatment discontinuation in 0.8% of patients.
Slovenian: Proteinurija je povzročila trajno ukinitev zdravljenja pri 0,8 % bolnikov.
English: • feeling bloated or having excess wind
Slovenian: • občutek napihnjenosti ali vetrovi,
English: Special populations Elderly population
Slovenian: Posebne skupine bolnikov Starejša populacija
English: Lenvatinib and its metabolites are excreted in rat milk.
Slovenian: Lenvatinib in njegovi presnovki se izločajo v mleko podgan.
English: Non-Gastrointestinal fistula
Slovenian: ne-gastrointestinalna fistulao
English: Some reports of fistula and pneumothorax occurred in association with tumour regression or necrosis.
Slovenian: O nekaterih primerih fistul in pnevmotoraksa so poročali v povezavi z regresijo tumorja ali nekrozo.
English: Patients ≥75 years, of white race or female sex or those with worse baseline hepatic impairment (Child-Pugh A score of 6 compared to score of 5) appear to have reduced tolerability to lenvatinib.
Slovenian: Zdi se, da bolniki, stari ≥ 75 let, ki pripadajo beli rasi ali so ženskega spola ali bolniki s slabšo okvaro jeter v izhodišču (rezultat Child-Pugh A 6 v primerjavi z rezultatom 5), slabše prenašajo lenvatinib.
English: • have a history of abnormal connections (known as a fistula) between different organs in the body or from an organ to the skin
Slovenian: • ste v preteklosti imeli nenormalne povezave (ki jim rečemo fistula) med različnimi organi v telesu ali med organom in kožo;
English: Myocardial infarction includes myocardial infarction and acute myocardial infarction.
Slovenian: Miokardni infarkt vključuje miokardni infarkt in akutni miokardni infarkt.
English: Metastases were present in 99% of the patients: lungs in 89.3%, lymph nodes in 51.5%, bone in 38.8%, liver in 18.1%, pleura in 16.3%, and brain in 4.1%.
Slovenian: Metastaze so bile prisotne pri 99 % bolnikov: v pljučih pri 89,3 %, v bezgavkah pri 51,5 %, v kosteh pri 38,8 %, v jetrih pri 18,1 %, v plevri pri 16,3 % in v možganih pri 4,1 %.
English: Elevation of TSH above the upper limit of normal was observed post baseline in 69.6% of lenvatinib-treated patients.
Slovenian: Zvišanje ravni TSH nad zgornjo mejo normalnega razpona so po izhodišču ugotovili pri 69,6 % bolnikov, zdravljenih z lenvatinibom.
English: Patients with a baseline Child Pugh (CP) score of 6 (about 20% patients in the REFLECT study) had a higher incidence of decreased appetite, fatigue, proteinuria, hepatic encephalopathy and hepatic failure compared to patients with a baseline CP score of 5.
Slovenian: Bolniki z izhodiščno oceno Child Pugh (CP) 6 (približno 20 % bolnikov v študiji REFLECT) so imeli večjo incidenco zmanjšanega apetita, utrujenosti, proteinurije, jetrne encefalopatije in jetrne odpovedi v primerjavi z bolniki z izhodiščno oceno CP 5.
English: Lenvatinib is for oral use.
Slovenian: Lenvatinib je namenjen za peroralno uporabo.
English: Four (1.5%) subjects treated with lenvatinib attained a CR and 165 subjects (63.2%) had a PR, while no subjects treated with placebo had a CR and 2 (1.5%) subjects had a PR.
Slovenian: Štirje (1,5 %) preiskovanci, zdravljeni z lenvatinibom, so dosegli CR in 165 preiskovancev (63,2 %) je imelo PR, medtem ko nobeden od preiskovancev, ki so prejemali placebo, ni imel CR, 2 preiskovanca (1,5 %) pa sta imela PR.
English: Proteinuria led to permanent treatment discontinuation in 0.6% of patients.
Slovenian: Proteinurija je povzročila trajno ukinitev zdravljenja pri 0,6 % bolnikov.
English: Lenvatinib showed minimal or no inhibitory activities toward P-gp-mediated and breast cancer resistance protein (BCRP)-mediated transport activities.
Slovenian: Lenvatinib je pokazal minimalno ali nikakršno inhibicijsko aktivnost proti prenašalskim aktivnostim, ki jih posredujeta P-gp in protein odpornosti pri raku dojke (BCRP - breast cancer resistance protein).
English: • need to have a surgical procedure.
Slovenian: • boste morali prestati kirurški poseg.
English: Prior surgery and radiotherapy may be contributing risk factors.
Slovenian: Predhodna operacija in zdravljenje z obsevanjem sta lahko dejavnika tveganja, ki prispevata k nastanku fistul.
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.
Slovenian: Z jetri povezani neželeni učinki, o katerih so najpogosteje poročali pri bolnikih z DTC, zdravljenih z lenvatinibom, vključujejo zvišanje alanin-aminotransferaze (ALT), aspartat-aminotransferaze (AST) in bilirubina v krvi.
English: A single 32-mg dose of lenvatinib did not prolong the QT/QTc interval based on results from a thorough QT study in healthy volunteers; however, QT/QTc interval prolongation has been reported at a higher incidence in patients treated with lenvatinib than in patients treated with placebo (see sections 4.4 and 4.8).
Slovenian: Enkraten 32-miligramski odmerek lenvatiniba sodeč po rezultatih temeljite študije intervala QT pri zdravih prostovoljcih ni podaljšal intervala QT/QTc; so pa o večji incidenci podaljšanja intervala QT/QTc poročali pri bolnikih, zdravljenih z lenvatinibom, kot pri bolnikih, ki so prejemali placebo (glejte poglavji 4.4 in 4.8).
English: Hypercholesterolaemia includes hypercholesterolaemia and increased blood cholesterol.
Slovenian: Hiperholesterolemija vključuje hiperholesterolemijo in zvišan holesterol v krvi.
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).
Slovenian: Ugotovili so, da so poglavitne presnovne poti pri ljudeh oksidacija z aldehidno oksidazo, demetilacija s CYP3A4, konjugacija z glutationom z odstranitvijo O-arilne skupine (klorofenilni del molekule) in kombinacije teh presnovnih poti, ki jim sledijo nadaljnje biotransformacije (npr. glukuronidacija, hidroliza glutationskega dela molekule, razgradnja cisteinskega dela molekule in intramolekulska prerazporeditev cisteinilglicinskih in cisteinskih konjugatov s poznejšo dimerizacijo).
English: Adjusted Doseb (<60 kg BW)
Slovenian: Prilagojen odmerekb (< 60 kg TM)
English: Thyroid function should be monitored before initiation of, and periodically throughout, treatment with lenvatinib.
Slovenian: Funkcijo ščitnice je treba spremljati pred začetkom, nato pa v rednih presledkih ves čas zdravljenja z lenvatinibom.
English: Limited data are available for patients of ethnic origin other than Caucasian or Asian, and in patients aged ≥75 years.
Slovenian: Za bolnike, ki niso bele ali azijske rase, in za bolnike, stare 75 let ali več, je na voljo malo podatkov.
English: Hepatic failure (including fatal events in 12 patients) occurred in 3.6% of patients (all were ≥ Grade 3).
Slovenian: Jetrna odpoved (vključno z 12 smrtnimi izidi) je nastopila pri 3,6 % bolnikov (vsi so bili stopnje ≥ 3).
English: One occurred in a patient with no liver metastases.
Slovenian: En primer je nastopil pri bolniku brez metastaz v jetrih.
English: Discontinue
Slovenian: prekinite
English: Radioiodine-refractory differentiated thyroid cancer
Slovenian: Proti radioaktivnemu jodu odporni diferencirani rak ščitnice
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.
Slovenian: Bolniki z majhno telesno maso (< 60 kg) so imeli večjo incidenco PPE, proteinurije, hipokalciemije in hiponatriemije stopnje 3 ali 4 in nagnjenost k večji incidenci zmanjšanega apetita stopnje 3 ali 4.
English: Neutropenia includes neutropenia and decreased neutrophil count decreased.
Slovenian: Nevtropenija vključuje nevtropenijo in zmanjšano število nevtrofilcev.
English: Hepatic encephalopathy (including fatal events in 4 patients) occurred in 8.4% of patients (5.5% were ≥ Grade 3).
Slovenian: Jetrna encefalopatija (vključno s 4 smrtnimi izidi) je nastopila pri 8,4 % bolnikov (5,5 % jih je bilo stopnje ≥ 3).
English: Management of some adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy.
Slovenian: Zaradi obvladovanja nekaterih neželenih učinkov utegnejo biti potrebne prekinitev odmerjanja, prilagoditev odmerka ali ukinitev zdravljenja z lenvatinibom.
English: Amongst 1,823 patients treated with lenvatinib monotherapy in clinical trials, there were 5 cases (0.3%) of PRES (0.2% were Grade 3 or 4), all of which resolved after treatment and/or dose interruption, or permanent discontinuation.
Slovenian: Med 1823 bolniki, zdravljenimi z lenvatinibom v monoterapiji v kliničnih preskušanjih, je bilo 5 primerov (0,3 %) PRES (0,2 % jih je bilo stopnje 3 ali 4), od katerih so vsi okrevali po zdravljenju in/ali prekinitvi odmerjanja ali trajni ukinitvi.
English: Non-gastrointestinal fistula includes cases of fistula occurring outside of the stomach and intestines such as tracheal, tracheo-oesophageal, oesophageal, female genital tract fistula, and cutaneous fistula.
Slovenian: Ne-gastrointestinalna fistula vključuje primere fistule, ki nastane zunaj želodca in črevesa, kot so trahealna, traheo-ezofagealna, ezofagealna fistula, fistula ženskih spolovil in kožna fistula.
English: Lenvatinib has not been studied in patients with severe hepatic imparement (Child-Pugh C) and is not recommended for use in these patients.
Slovenian: Lenvatiniba niso preučevali pri bolnikih s hudo jetrno okvaro (Child-Pugh C), zato uporaba pri teh bolnikih ni priporočljiva.
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.
Slovenian: Med 1823 bolniki, zdravljenimi z lenvatinibom v monoterapiji v kliničnih preskušanjih, je bilo 10 primerov (0,5 %) arterijskih trombembolij (5 primerov miokardnega infarkta in 5 primerov cerebrovaskularnega insulta) s smrtnim izidom.
English: Since lenvatinib is mainly eliminated by hepatic metabolism, an increase in exposure in patients with moderate to severe hepatic impairment is expected.
Slovenian: Ker se lenvatinib pretežno izloča s presnovo v jetrih, se pri bolnikih z zmerno do hudo jetrno okvaro pričakuje večja izpostavljenost.
English: Patients of age ≥75 years, of Asian race, with comorbidities (such as hypertension, and hepatic or renal impairment), or body weight below 60 kg appear to have reduced tolerability to lenvatinib (see section 4.8, Other special populations).
Slovenian: Zdi se, da starejši bolniki, stari ≥ 75 let, ki pripadajo azijski rasi in imajo sočasne druge bolezni (na primer hipertenzijo in okvaro jeter ali ledvic) ali telesno maso, ki je manjša od 60 kg, slabše prenašajo lenvatinib (glejte poglavje 4.8, Druge posebne skupine bolnikov).
English: • you are breast-feeding (see the section below on Contraception, pregnancy and breast-feeding).
Slovenian: • če dojite (glejte poglavje Kontracepcija, nosečnost in dojenje v nadaljevanju).
English: Limited data are available on use in patients aged ≥75 years (see also section 4.8, Other special populations).
Slovenian: O uporabi pri bolnikih, starih 75 let ali več, je na voljo malo podatkov (glejte tudi poglavje 4.8, Druge posebne skupine bolnikov).
English: No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment.
Slovenian: Prilagoditev začetnega odmerka na podlagi ledvične funkcije pri bolnikih z blago ali zmerno okvaro ledvic ni potrebna.
English: The suspension is to be swallowed.
Slovenian: Suspenzijo spijemo.
English: • underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin)
Slovenian: • premalo aktivna ščitnica (utrujenost, pridobivanje telesne mase, zaprtje, občutek mraza, suha koža),
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eisai GmbH
Slovenian: Imetnik dovoljenja za promet z zdravilom Eisai GmbH
English: No formal studies of the effect of lenvatinib on wound healing have been conducted.
Slovenian: Formalnih študij o učinku lenvatiniba na celjenje ran niso izvedli.
English: The median time to first onset was 11.9 weeks.
Slovenian: Mediani čas do nastopa je bil 11,9 tednov.
English: Hepatic encephalopathyl,‡,†
Slovenian: jetrna encefalopatijal,‡,†
English: Accidental medication errors resulting in single doses of 40 to 48 mg have occurred in clinical trials.
Slovenian: V kliničnih preskušanjih je prišlo do nehotenih napak pri dajanju zdravila, ki so imele za posledico enkratne odmerke od 40 mg do 48 mg.
English: Avoid driving or using machines if you feel dizzy or tired.
Slovenian: Če ste omotični ali utrujeni, ne vozite in ne uporabljajte strojev.
English: A 5-mg dose was evaluated in 6 subjects with severe hepatic impairment (Child-Pugh C).
Slovenian: Petmiligramski odmerek so ovrednotili pri 6 preiskovancih s hudo okvaro jeter (Child-Pugh C).
English: Lenvatinib displays minimimal accumulation at steady state.
Slovenian: Lenvatinib kaže v stanju dinamičnega ravnovesja minimalno kopičenje.
English: The median time to onset was 6.1 weeks.
Slovenian: Mediani čas do nastopa je bil 6,1 tedna.
English: The median time to onset of hepatotoxocity adverse reactions was 6.4 weeks.
Slovenian: Mediani čas do nastopa s hepatotoksičnostjo povezanih neželenih učinkov je bil 6,4 tednov.
English: Lenvatinib exposure, based on dose-adjusted AUC0-t and AUC0-inf data, was 119%, 107%, and 180% of normal for subjects with mild, moderate, and severe hepatic impairment, respectively.
Slovenian: Izpostavljenost lenvatinibu na podlagi za odmerek popravljenih podatkov AUC0-t in AUC0-inf je bila 119 %, 107 % oziroma 180 % normalne vrednosti pri preiskovancih z blago, zmerno oziroma hudo okvaro jeter.