FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean terminal exponential half-life of lenvatinib is approximately 28 hours.
Slovenian: Povprečna končna eksponencialna razpolovna doba lenvatiniba je približno 28 ur.
English: What Kisplyx is and what it is used for
Slovenian: Kaj je zdravilo Kisplyx in za kaj ga uporabljamo
English: Figure 2: Kaplan-Meier Plot of Overall Survival
Slovenian: Slika 2: Kaplan-Meierjeva krivulja celotnega preživetja
English: Genotoxicity Lenvatinib was not genotoxic.
Slovenian: Genotoksičnost Lenvatinib ni bil genotoksičen.
English: Patients with high ECOG performance status
Slovenian: Bolniki z visokim stanjem zmogljivosti po ECOG
English: In most cases, gastrointestinal perforation and fistulae occurred in patients with risk factors such as prior surgery or radiotherapy.
Slovenian: Pri večini primerov so gastrointestinalna perforacija in fistule nastale pri bolnikih z dejavniki tveganja, na primer predhodnim kirurškim posegom ali radioterapijo.
English: The capsules can be swallowed whole with water.
Slovenian: Kapsule je mogoče pogoltniti cele z nekaj vode.
English: If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration.
Slovenian: Če bolnik pozabi vzeti odmerek in ga ne more vzeti v naslednjih 12 urah, naj tisti odmerek preskoči in ob običajnem času uporabe vzame naslednji odmerek.
English: Lenvatinib has a minor influence on the ability to drive and use machines, due to undesirable effects such as fatigue and dizziness.
Slovenian: Lenvatinib ima blag vpliv na sposobnost vožnje in upravljanja s stroji, in to zaradi neželenih učinkov, kot sta utrujenost in omotica.
English: Similarly, no induction of P-gp mRNA expression was observed.
Slovenian: Prav tako niso opazili nikakršne indukcije ekspresije P-gp mRNA.
English: Please see distribution section.
Slovenian: Glejte poglavje o porazdelitvi.
English: All patients had a baseline ECOG PS of either 0 (55%) or 1 (45%) with similar distribution across the 3 treatment arms.
Slovenian: Vsi bolniki so imeli ECOG PS bodisi 0 (55 %) ali 1 (45 %) s podobno porazdelitvijo po vseh 3 skupinah zdravljenja.
English: The mechanism of action for the worsening of hypercholesterolemia with the combination has not been studied directly and is not fully elucidated.
Slovenian: Mehanizma delovanja za poslabšanje hiperholesterolemije pri kombinaciji zdravil niso raziskovali neposredno in ni povsem pojasnjen.
English: When necessary, manage hypertension as recommended in Table 3.
Slovenian: Po potrebi zdravite hipertenzijo po priporočilih v preglednici 3.
English: Data cut-off date = 13 Jun 2014
Slovenian: Datum zaključka zbiranja podatkov = 13. junij 2014.
English: The early detection and effective management of hypertension are important to minimise the need for lenvatinib dose interruptions and reductions.
Slovenian: Zgodnje odkrivanje in učinkovito zdravljenje hipertenzije sta pomembna, da se kar najbolj zmanjša potreba po prekinitvah odmerjanja in zmanjševanjih odmerka lenvatiniba.
English: The median time to onset was 6.7 weeks.
Slovenian: Mediani čas do začetka je bil 6,7 tedna.
English: Patients with an ECOG (Eastern Cooperative Oncology Group) performance status of 2 or higher were excluded from the RCC study (see section 5.1).
Slovenian: Bolniki s stanjem zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 2 ali več so bili izključeni iz študije RCC (glejte poglavje 5.1).
English: • Do not take Kisplyx if you are planning to become pregnant during your treatment.
Slovenian: • Ne jemljite zdravila Kisplyx, če načrtujete zanositev med zdravljenjem.
English: The daily doses of lenvatinib and, if necessary, everolimus are to be modified as needed according to the dose/toxicity management plan.
Slovenian: Dnevni odmerek lenvatiniba in po potrebi tudi everolimusa spreminjajte po potrebi v skladu z načrtom za obvladovanje odmerka/toksičnosti.
English: • The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30, 60 or 90 hard capsules.
Slovenian: • Kapsule so na voljo v pretisnih omotih iz poliamida/aluminija/PVC, prekritih z aluminijevo folijo za predrtje, v kartonskih škatlah s po 30, 60 ali 90 trdimi kapsulami.
English: Not Known (the following side effects have been reported since the marketing of lenvatinib but the frequency for them to occur is not known)
Slovenian: Neznana pogostnost (o naslednjih neželenih učinkih so poročali, odkar je prišel lenvatinib na trg, vendar pogostnost, s katero se pojavljajo, ni znana):
English: **:These adverse reactions occur more frequently with combination therapy compared to lenvatinib monotherapy.
Slovenian: **: Ti neželeni učinki se pojavljajo pogosteje pri kombinirani terapiji kot pri monoterapiji z lenvatinibom.
English: In vitro studies indicate that lenvatinib is a substrate for P-gp and BCRP.
Slovenian: In vitro študije kažejo, da je lenvatinib substrat za P-gp in BCRP.
English: Reactions were reported at various time points during treatment ranging from two weeks to greater than 1 year from initiation of lenvatinib, with a median latency of about 3 months.
Slovenian: O reakcijah so poročali ob različnih časovnih točkah med zdravljenjem, od dveh tednov do več kot enega leta po uvedbi lenvatiniba, mediana latenca je bila okrog 3 mesece.
English: Resolves to Grade 0, 1 or 2.
Slovenian: Izboljša se na stopnjo 0, 1 ali 2.
English: Other medicines and Kisplyx
Slovenian: Druga zdravila in zdravilo Kisplyx
English: The European Medicines Agency has waived the obligation to submit the results of studies with lenvatinib in all subsets of the paediatric population in Renal Cell Carcinoma (RCC).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z lenvatinibom za vse podskupine pediatrične populacije s karcinomom ledvičnih celic (RCC).
English: The Phase 2 portion enrolled a total of 153 patients with unresectable advanced or metastatic RCC following 1 prior VEGF-targeted treatment.
Slovenian: V delu faze 2 je bilo vključenih vsega skupaj 153 bolnikov z neresektabilnim napredovalim ali metastatskim RCC po enem predhodnem zdravljenju, usmerjenem v VEGF.
English: The suspension is to be swallowed.
Slovenian: Suspenzijo naj spije.
English: • high levels of protein in the urine and urinary infections (increased frequency in urination and pain in passing urine)
Slovenian: • zvišana raven beljakovin v urinu in okužbe sečil (pogostnejše uriniranje in bolečine pri uriniranju),
English: What you need to know before you take Kisplyx
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Kisplyx
English: You may need to have additional treatment with other medicines, to take a lower dose of Kisplyx, or to take extra care due to an increased risk of side effects.
Slovenian: Mogoče se boste morali dodatno zdraviti z drugimi zdravili, jemati manjši odmerek zdravila Kisplyx ali pa biti zaradi zvečanega tveganja neželenih učinkov še posebej pazljivi.
English: Caregivers should not open the capsule, in order to avoid repeated exposure to the contents of the capsule.
Slovenian: Skrbniki bolnikov naj ne odpirajo kapsul, da se bodo izognili ponavljajočemu se izpostavljanju vsebini kapsul.
English: Before taking Kisplyx, your doctor may carry out some blood tests, for example to check your blood pressure and your liver or kidney function and to see if you have low levels of salt and high levels of thyroid stimulating hormone in your blood.
Slovenian: Pred začetkom jemanja zdravila Kisplyx vam lahko zdravnik naredi nekatere krvne preiskave, lahko vam na primer kontrolira krvni tlak in delovanje jeter ali ledvic in se prepriča, ali imate nizko raven soli in visoko raven tirotropnega hormona v krvi.
English: Of the 153 patients randomly allocated, 73% were male, the median age was 61 years, 37% were 65 years or older, 7% were 75 years or older, and 97% were Caucasian.
Slovenian: Od 153 randomiziranih bolnikov je bilo 73 % moških, mediana starost je bila 61 let, 37 % jih je bilo starih 65 let ali več, 7 % jih je bilo starih 75 let ali več, 97 % pa jih je bilo bele rase.
English: • weigh less than 60 kg
Slovenian: • tehtate manj kot 60 kg;
English: Lenvatinib dose should be interrupted or dose adjusted as necessary depending on severity, presence of ECG changes, and persistence of hypocalcaemia.
Slovenian: Odmerjanje lenvatiniba je treba prekiniti ali odmerek prilagoditi po potrebi, odvisno od resnosti, prisotnosti sprememb EKG in trdovratnosti hipokalciemije.
English: These proteins can be present in high amounts in cancer cells, and by blocking their action Kisplyx may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs.
Slovenian: Te beljakovine so lahko prisotne v velikih količinah v rakastih celicah, z zaviranjem njihovega delovanja pa zdravilo Kisplyx lahko upočasni hitrost razmnoževanja rakavih celic in rast tumorja in pomaga prekiniti preskrbo s krvjo, ki jo rak potrebuje.
English: Tumour assessment was based on RECIST 1.1 criteria.
Slovenian: Ocenjevanje tumorja je temeljilo na merilih RECIST 1.1.
English: • are a woman able to become pregnant (see the section “Contraception, pregnancy and breast-feeding”
Slovenian: • ste ženska, ki bi lahko zanosila (glejte poglavje »Kontracepcija, nosečnost in dojenje« v nadaljevanju);
English: Not all pack sizes may be marketed .
Slovenian: Na trgu morda ni vseh navedenih pakiranj.
English: The additional liquid must be swallowed.
Slovenian: Nato mora spiti dodatno tekočino.
English: Body weight below 60 kg
Slovenian: Telesna masa, manjša od 60 kg
English: Blood pressure (BP) should be well controlled prior to treatment with lenvatinib and, if patients are known to be hypertensive, they should be on a stable dose of antihypertensive therapy for at least 1 week prior to treatment with lenvatinib.
Slovenian: Krvni tlak (KT) naj bo pred zdravljenjem z lenvatinibom dobro nadzorovan in če je za bolnike znano, da so hipertenzivni, naj bodo vsaj 1 teden pred zdravljenjem z lenvatinibom na stabilnem odmerku antihipertenzivne terapije.
English: Kisplyx treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies.
Slovenian: Zdravljenje z zdravilom Kisplyx mora uvesti in nadzorovati zdravnik z izkušnjami pri uporabi zdravil proti raku.
English: Periodic monitoring of ECG and electrolytes (magnesium, potassium and calcium) should be considered during treatment.
Slovenian: Med zdravljenjem moramo razmisliti o spremljanju EKG in elektrolitov (magnezij, kalij in kalcij) v rednih časovnih presledkih.
English: cData cut-off date = 31 Jul 2015
Slovenian: cDatum zaključka zbiranja podatkov = 31. julij 2015.
English: Grade 4*
Slovenian: stopnja 4*
English: A total of 62 patients received the combination of lenvatinib and everolimus at the recommended dose.
Slovenian: Skupaj 62 bolnikov je prejemalo kombinacijo lenvatiniba in everolimusa v priporočenem odmerku.
English: Figure 1: Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment)
Slovenian: Slika 1: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (raziskovalčeva ocena)
English: Alanine aminotransferase increased‡
Slovenian: zvišana alaninaminotransferaza‡
English: The analogous median apparent volume of distribution at steady-state (Vz/Fss) was also generally consistent and ranged from 43.2 L to 121 L.
Slovenian: navidezni porazdelitveni volumen v stanju ravnovesja (Vz/Fss) je bil tudi na splošno skladen in je segal od 43,2 l do 121 l.
English: Do not take Kisplyx if:
Slovenian: Ne jemljite zdravila Kisplyx:
English: Hypertension includes: hypertension, hypertensive crisis, increased blood pressure diastolic, and increased blood pressure.
Slovenian: Hipertenzija vključuje: hipertenzijo, hipertenzivno krizo, zvišanje diastoličnega krvnega tlaka in zvišanje krvnega tlaka.
English: bStratified hazard ratio is based on a stratified Cox regression model including treatment as a covariate factor and haemoglobin and corrected serum calcium as strata.
Slovenian: bStratificirano razmerje tveganja temelji na Coxovem stratificiranem regresijskem modelu, ki je vključil obravnavo kot kovariatni faktor ter hemoglobin in popravljeni serumski kalcij kot strata.
English: Kisplyx blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them to grow.
Slovenian: Zdravilo Kisplyx zavira delovanje beljakovin, imenovanih receptorji tirozin-kinaze (RTK), ki so vpletene v razvoj novih krvnih žil, ki preskrbujejo celice s kisikom in hranilnimi snovmi in jim pomagajo rasti.
English: Electrolyte disturbances such as hypokalaemia, hypocalcaemia, or hypomagnesaemia increase the risk of QT prolongation; therefore electrolyte abnormalities should be monitored and corrected in all patients before starting treatment.
Slovenian: Motnje elektrolitov, na primer hipokaliemija, hipokalciemija ali hipomagneziemija, zvečujejo tveganje podaljšanja intervala QT; zato moramo spremljati in popraviti motnje elektrolitov pri vseh bolnikih, preden začnemo z zdravljenjem.
English: The final dose level in the combination arm was 18 mg for 29% of patients, 14 mg for 31% of patients, 10 mg for 23% of patients, 8 mg for 16% of patients and 4 mg for 2% of patients.
Slovenian: Končna raven odmerka v skupini s kombinacijo zdravil je bila 18 mg pri 29 % bolnikov, 14 mg pri 31 % bolnikov, 10 mg pri 23 % bolnikov, 8 mg pri 16 % bolnikov in 4 mg pri 2 % bolnikov.
English: Over this range, the median accumulation index (Rac) ranged from 0.96 (20 mg) to 1.54 (6.4 mg).
Slovenian: V tem območju je indeks medianega kopičenja (Rac) segal od 0,96 (20 mg) do 1,54 (6,4 mg).
English: Patients were required, among others, to have histological confirmation of predominant clear cell RCC, radiographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1), one prior VEGF-targeted therapy and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Slovenian: Bolniki so med drugim morali imeti histološko potrditev RCC s prevladujočimi svetlimi celicami, rentgenski dokaz napredovanja bolezni po merilih za ocenjevanje odziva pri čvrstih tumorjih, verzija 1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1RECIST 1.1), eno predhodno zdravljenje, usmerjeno v VEGF, in status zmogljivosti (Performance Status - PS) Eastern Cooperative Oncology Group (ECOG) 0 ali 1.
English: Kisplyx is a medicine that contains the active substance lenvatinib.
Slovenian: Kisplyx je zdravilo, ki vsebuje zdravilno učinkovino lenvatinib.
English: Kisplyx may be restarted once adequate wound healing is established.
Slovenian: Zdravilo Kisplyx se lahko ponovno uvede, ko je ugotovljeno ustrezno celjenje ran;
English: Hepatocellular damage/hepatitisi
Slovenian: holecistitis hepatocelularna poškodba/hepatitisi
English: • Caregivers should not open capsules to avoid exposure to the contents of the capsule.
Slovenian: • Skrbniki bolnikov naj ne odpirajo kapsul, da ne bodo prišli v stik z vsebino kapsule.
English: • other types of fistulae (an abnormal connection between different organs in the body or from the skin to an underlying structure such as throat and windpipe).
Slovenian: • druge vrste fistul (fistula je nenormalna povezava med različnimi telesnimi organi ali od kože do spodaj ležeče strukture, na primer žrela in sapnika).
English: What Kisplyx is and what it is used for What you need to know before you take Kisplyx How to take Kisplyx
Slovenian: Kaj je zdravilo Kisplyx in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Kisplyx Kako jemati zdravilo Kisplyx Možni neželeni učinki
English: Contraception, pregnancy and breast-feeding
Slovenian: Kontracepcija, nosečnost in dojenje
English: If you are not sure talk to your doctor before taking Kisplyx.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, preden začnete jemati zdravilo Kisplyx.
English: Resolves to Grade 0-1.
Slovenian: Izboljša se na stopnjo 0-1.
English: • black, tarry, or bloody stools, or coughing up of blood - these may be signs of bleeding inside your body.
Slovenian: • črno, smolasto ali krvavo blato ali izkašljevanje krvi - to so lahko znaki krvavitve znotraj telesa;
English: It is used in combination with everolimus to treat patients with advanced kidney cancer (advanced renal cell carcinoma) where other treatments (so-called “VEGF-targeted therapy”) have not helped stop the disease.
Slovenian: Uporablja se skupaj z everolimusom za zdravljenje bolnikov z napredovalim ledvičnim rakom (napredovali karcinom ledvičnih celic), če drugi načini zdravljenja (tako imenovana »terapija, usmerjena v VEGF«) niso pomagali zaustaviti bolezni.
English: • Your doctor may reduce your dose if you experience side effects.
Slovenian: • Zdravnik vam lahko zmanjša odmerek, če se pri vas pojavijo neželeni učinki.
English: Your doctor may consider stopping Kisplyx if you will be undergoing a major surgical procedure as Kisplyx may affect wound healing.
Slovenian: Zdravnik bo morda razmislil o prekinitvi zdravljenja z zdravilom Kisplyx, če boste imeli večji kirurški poseg, saj zdravilo Kisplyx lahko vpliva na celjenje ran.
English: Mild to moderate adverse reactions (e.g., Grade 1 or 2) generally do not warrant interruption of the combination, unless intolerable to the patient despite optimal management.
Slovenian: Blagi do zmerni neželeni učinki (npr. stopnje 1 ali 2) na splošno ne upravičijo prekinitve odmerjanja kombinacije zdravil, razen če jih bolnik ne more prenašati kljub optimalni obravnavi.
English: • Swallow the capsules whole with water or dissolved.
Slovenian: • Kapsule pogoltnite cele z vodo ali raztopljene v njej.
English: Based on a population pharmacokinetic analysis of patients receiving up to 24 mg lenvatinib once daily, age, sex, weight, and race (Japanese vs. other, Caucasian vs. other) had no significant effects on clearance (see section 4.2).
Slovenian: Na podlagi populacijske farmakokinetične analize bolnikov, ki so prejemali do 24 mg lenvatiniba enkrat na dan, starost, spol, telesna masa in rasa (Japonci v primerjavi z drugimi, belci v primerjavi z drugimi) niso pomembno vplivali na očistek (glejte poglavje 4.2).
English: Tumour assessments were evaluated according to RECIST 1.1.
Slovenian: Ocenjevanje tumorjev so vrednotili po RECIST 1.1.
English: Blood pressure (BP) level
Slovenian: Raven krvnega tlaka (KT)
English: Carcinogenicity studies have not been conducted with lenvatinib.
Slovenian: Študij kancerogenosti z lenvatinibom niso opravili.
English: Alternatively, the lenvatinib capsules may be added without breaking or crushing them to a tablespoon of water or apple juice in a small glass to produce a suspension.
Slovenian: Druga možnost je, da bolnik doda kapsule lenvatiniba, ne da bi jih odprl ali zdrobil, jedilni žlici vode ali sadnega soka v majhnem kozarcu, da bo nastala suspenzija.
English: Paediatric population See section 4.2 for information on paediatric use.
Slovenian: Pediatrična populacija Za podatke o pediatrični uporabi glejte poglavje 4.2.
English: To dissolve them, pour a tablespoon of water or apple juice into a small glass and put the capsules into the liquid without breaking or crushing them.
Slovenian: Raztopite jih tako, da nalijete jedilno žlico vode ali jabolčnega soka v majhen kozarec in date kapsule v tekočino, ne da bi jih odprli ali zdrobili.
English: • low levels of platelets in the blood which may lead to bruising and difficulty in wound healing
Slovenian: • nizka raven krvnih ploščic v krvi, kar lahko povzroči modrice in oteženo celjenje ran.
English: Tabulated list of adverse reactions for RCC and DTC studies Similar adverse reactions were observed in clinical trials in RCC and DTC.
Slovenian: Seznam neželenih učinkov v študijah RCC in DTC V kliničnih preskušanjih pri RCC in DTC so ugotovili podobne neželene učinke.
English: Kisplyx is not recommended for use in children and adolescents.
Slovenian: Pri otrocih in mladostnikih uporaba zdravila Kisplyx ni priporočljiva.
English: A multicentre, randomised, open-label, trial was conducted to determine the safety and efficacy of lenvatinib administered alone or in combination with everolimus in subjects with unresectable advanced or metastatic RCC.
Slovenian: Opravili so multicentrično, randomizirano, odprto preskušanje, da bi ugotovili varnost in učinkovitost lenvatiniba, danega bodisi samega bodisi v kombinaciji z everolimusom pri preiskovancih z neresektabilnim napredovalim ali metastatskim RCC.
English: Diarrhoea resulted in discontinuation in one patient.
Slovenian: Driska je povzročila ukinitev zdravljenja pri enem bolniku.
English: Treatment should be discontinued in case of life-threatening reactions (e.g., Grade 4) with the exception of laboratory abnormalities judged to be non-life-threatening, in which case they should be managed as severe reactions (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: Caution should be taken in patients receiving agents acting on the renin-angiotensin aldosterone system given a potentially higher risk for acute renal failure with the combination treatment.
Slovenian: Pri bolnikih, ki jemljejo zdravila, ki delujejo na renin-angiotenzin-aldosteronski sistem, je potrebna previdnost zaradi možnega večjega tveganja akutne odpovedi ledvic pri kombiniranem zdravljenju.
English: All events of hypothyroidism in the lenvatinib plus everolimus-treated group were of Grade 1 or 2.
Slovenian: Vsi dogodki hipotiroidizma v skupini, zdravljeni z lenvatinibom in everolimusom, so bili stopnje 1 ali 2.
English: • Use highly effective contraception while taking this medicine, and for at least one month after you finish treatment.
Slovenian: • Med jemanjem tega zdravila in vsaj še en mesec po končanem zdravljenju morate uporabljati učinkovito kontracepcijo.
English: • If you become pregnant while being treated with Kisplyx, tell your doctor immediately.
Slovenian: • Če med zdravljenjem z zdravilom Kisplyx zanosite, to takoj povejte zdravniku.
English: The degree of tumour invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.
Slovenian: Treba je upoštevati stopnjo tumorske invazije/infiltracije večjih krvnih žil (npr. karotidnih arterij) zaradi možnega tveganja resne krvavitve, povezane z zmanjšanjem tumorske mase/nekrozo tumorja po zdravljenju z lenvatinibom.
English: Based on the results of a post-hoc exploratory analysis in a limited number of patients per subgroup, the positive effect on PFS was seen regardless of which prior VEGF-targeted therapy was used: sunitinib (Hazard ratio [HR] = 0.356 [95% CI: 0.188, 0.674] or other therapies (HR = 0.350 [95% CI: 0.148, 0.828]).
Slovenian: Na podlagi rezultatov post-hoc eksploratorne analize pri manjšem številu bolnikov na podskupino je bil pozitivni učinek na PFS viden ne glede na to, katero predhodno zdravljenje, usmerjeno v VEGF, so uporabljali: sunitinib (razmerje tveganja [HR] = 0,356 [95 % IZ: 0,188, 0,674] ali druge terapije (HR = 0,350 [95 % IZ: 0,148, 0,828]).
English: In patients with solid tumours administered single and multiple doses of lenvatinib once daily, exposure to lenvatinib (Cmax and AUC) increased in direct proportion to the administered dose over the range of 3.2 to 32 mg once-daily.
Slovenian: Pri bolnikih s čvrstimi tumorji, ki so prejeli enkratne in večkratne odmerke lenvatiniba enkrat na dan, se je izpostavljenost lenvatinibu (Cmax in AUC) zvečala neposredno sorazmerno danemu odmerku v razponu od 3,2 do 32 mg enkrat na dan.
English: Table 5 Efficacy results in renal cell carcinoma lenvatinib 18 mg + everolimus 5 mg (N=51)
Slovenian: Preglednica 5 Rezultati učinkovitosti pri karcinomu ledvičnih celic lenvatinib 18 mg + everolimus 5 mg (N = 51)