natgillin/translations-raw huggingface dataset:
• have a history of abnormal passageways (known as a fistula) between different organs in the body or from an organ to the skin 
• ste v preteklosti imeli nenormalne povezave, (ki jim rečemo fistula) med različnimi organi v telesu ali med organom in kožo;
Kisplyx 10 mg hard capsules EU/1/16/1128/002 
Kisplyx 10 mg trde kapsule EU/1/16/1128/002
In patients, the median apparent volume of distribution (Vz/F) of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg. 
Pri bolnikih je mediani navidezni porazdelitveni volumen (Vz/F) prvega odmerka segal od 50,5 l do 92 l in je bil na splošno skladen v vseh skupinah odmerkov od 3,2 mg do 32 mg. Analogni mediani čas (meseci)
Amongst 1,166 patients treated with lenvatinib, there were 4 cases (0.3%) of PRES (0.3% were Grade 3 or 4), all of which resolved after treatment and/or dose interruption, or permanent discontinuation. 
Med 1166 bolniki, zdravljenimi z lenvatinibom, so bili 4 primeri (0,3 %) PRES (0,3 % jih je bilo stopnje 3 ali 4), od katerih so vsi okrevali po zdravljenju in/ali prekinitvi odmerjanja ali trajni ukinitvi.
Lenvatinib should be used with caution in such patients, given the reduced tolerability of lenvatinib in Asian and elderly patients (see section 4.8, Other special populations). 
Lenvatinib je treba pri takih bolnikih uporabljati previdno, saj bolniki, ki pripadajo azijski rasi, in starejši bolniki lenvatinib slabše prenašajo (glejte poglavje 4.8 Druge posebne skupine bolnikov).
EU/1/16/1128/002 (Pack size of 30 hard capsules) EU/1/16/1128/005 (Pack size of 60 hard capsules) EU/1/16/1128/006 (Pack size of 90 hard capsules) 
EU/1/16/1128/002 (pakiranje 30 trdih kapsul) EU/1/16/1128/005 (pakiranje 60 trdih kapsul) EU/1/16/1128/006 (pakiranje 90 trdih kapsul)
Although not studied directly with lenvatinib, the mechanism of action (MOA) for hypertension is postulated to be mediated by the inhibition of VEGFR2 in vascular endothelial cells. 
Čeprav mehanizma hipertenzijskega delovanja niso proučevali neposredno z lenvatinibom, predpostavljajo, da gre za inhibicijo VEGFR2 v vaskularnih endotelijskih celicah.
The majority of cases recovered or resolved following dose interruption or reduction, which occurred in 13.0% and 13.4% of patients, respectively. 
Večina primerov se je izboljšala ali izzvenela po prekinitvi odmerjanja ali zmanjšanju odmerka, do česar je prišlo pri 13,0 % oziroma pri 13,4 % bolnikov.
The most common adverse reactions (≥5%) resulting in dose reductions in the lenvatinib plus everolimus treated group were diarrhoea (21.0%), thrombocytopenia (6.5%), and vomiting (6.5%). 
Najpogostejši neželeni učinki (≥ 5 %), ki so povzročili zmanjšanje odmerkov v skupini, ki se je zdravila z lenvatinibom in everolimusom, so bili driska (21,0 %), trombocitopenija (6,5 %) in bruhanje (6,5 %).
Adverse reactions requiring dose modification of lenvatinib 
Preglednica 1 Neželeni učinki, pri katerih je potrebna sprememba odmerka lenvatiniba
Limited data are available on patients with a body weight below 60 kg with RCC (see also section 4.8, Other special populations). 
Za bolnike z RCC s telesno maso, manjšo od 60 kg, je na voljo malo podatkov (glejte tudi poglavje 4.8, Druge posebne skupine bolnikov).
EU/1/16/1128/001 (Pack size of 30 hard capsules) EU/1/16/1128/003 (Pack size of 60 hard capsules) EU/1/16/1128/004 (Pack size of 90 hard capsules) 
EU/1/16/1128/001 (pakiranje 30 trdih kapsul) EU/1/16/1128/003 (pakiranje 60 trdih kapsul) EU/1/16/1128/004 (pakiranje 90 trdih kapsul)
No adjustment of starting dose of the combination is required on the basis of hepatic function in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. 
Prilagoditev začetnega odmerka kombinacije zdravil na podlagi jetrne funkcije pri bolnikih z blago (Child-Pugh A) ali zmerno (Child-Pugh B) okvaro jeter ni potrebna.
Talk to your doctor before taking Kisplyx if you: 
Pred začetkom jemanja zdravila Kisplyx se posvetujte z zdravnikom, če:
Gastrointestinal and abdominal pain includes: abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, abdominal tenderness, epigastric discomfort, and gastrointestinal pain. 
Gastrointestinalna in abdominalna bolečina vključuje: nelagodje v trebuhu, bolečino v trebuhu, bolečino v spodnjem delu trebuha, bolečino v zgornjem delu trebuha, občutljivost trebuha, nelagodje v epigastriju in gastrointestinalno bolečino.
Hypocalcaemia‡ Hypercholesterolaemiab** 
Presnovne in prehranske motnje hipokalciemija‡ hiperholesterolemijab**
Patients were randomly allocated to one of 3 arms: 18 mg of lenvatinib plus 5 mg of everolimus, 24 mg of lenvatinib or 10 mg of everolimus using a 1:1:1 ratio. 
Bolniki so bili randomizirani v eno od 3 skupin: 18 mg lenvatiniba in 5 mg everolimusa, 24 mg lenvatiniba ali 10 mg everolimusa v razmerju 1:1:1.
There are limited data on patients of age ≥75 years with RCC. 
Za bolnike z RCC, stare ≥ 75 let, je na voljo malo podatkov.
Renal failure includes: acute prerenal failure, renal failure, acute kidney injury, and renal tubular necrosis. 
Odpoved ledvic vključuje: akutno prerenalno odpoved, odpoved ledvic, akutno poškodbo ledvic in ledvično tubulno nekrozo.
Cardiac failure Electrocardiogram QT prolonged Ejection fraction decreased 
popuščanje srca podaljšanje intervala QT na elektrokardiogramu zmanjšanje iztisne frakcije
Non-Gastrointestinal fistula 
Ne-gastrointestinalna fistula
In the DTC study (see Lenvima SmPC), hypertension (including hypertension, hypertensive crisis, blood pressure diastolic increased, and blood pressure increased) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group. 
V študiji DTC (glejte SmPC za zdravilo Lenvima) so poročali o hipertenziji (vključno s hipertenzijo, hipertenzivno krizo, zvišanim distoličnim krvnim tlakom in zvišanim krvnim tlakom) pri 72,8 % bolnikov, zdravljenih z lenvatinibom, in pri 16,0 % bolnikov v skupini, ki je prejemala placebo.
In the DTC study (see Lenvima SmPC), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group and no reports in the placebo group. 
V študiji DTC (glejte SmPC za zdravilo Lenvima) je bil en dogodek PRES (stopnje 2) v skupini, zdravljeni z lenvatinibom, in nobenih poročil v skupini s placebom.
How Kisplyx works 
Kako zdravilo Kisplyx deluje
There are limited data on patients with body weight <60 kg in RCC. 
Podatkov o bolnikih s telesno maso < 60 kg in RCC je malo.
All patients other than those with severe hepatic or renal impairment (see below) should initiate treatment at the recommended dose of 18 mg of lenvatinib with 5 mg of everolimus taken once daily, following which the dose should be further adjusted on the basis of individual tolerability. 
Vsi bolniki razen tistih, ki imajo hudo okvaro jeter ali ledvic (glejte v nadaljevanju), naj začnejo z zdravljenjem s priporočenim odmerkom 18 mg lenvatiniba in 5 mg everolimusa enkrat na dan, nato pa naj se odmerek nadalje prilagaja na podlagi prenašanja vsakega bolnika posebej.
The lenvatinib plus everolimus arm showed a statistically significant and clinically meaningful improvement in PFS compared with the everolimus arm. 
Skupina z lenvatinibom in everolimusom je pokazala statistično značilno in klinično pomembno izboljšanje PFS v primerjavi s skupino z everolimusom.
Severe (e.g., Grade 3) or intolerable adverse reactions require interruption of the combination of medicines until improvement of the reaction to Grade 0-1 or baseline. 
Ob hudih neželenih učinkih (npr. stopnje 3) ali neželenih učinkih, ki jih bolnik ne more prenašati, je potrebna prekinitev odmerjanja kombinacije zdravil do izboljšanja neželenega učinka na stopnjo 0-1 ali na izhodiščno stanje.
**.Identified from post-marketing use of lenvatinib 
***: Ugotovljeno pri uporabi lenvatiniba v obdobju trženja.
The most important serious adverse reactions were renal failure and impairment (11.3%), arterial thromboembolisms (3.9%)*, cardiac failure (1.6%), cerebral haemorrhage (1.6%), intracranial tumour haemorrhage (0.7%)*, PRES / RPLS (0.2%)*, and hepatic failure (0.2%)* (the asterisked frequencies are from the DTC patient population). 
Najpomembnejši resni neželeni učinki so bili odpoved in okvara ledvic (11,3 %), arterijske trombembolije (3,9 %)*, popuščanje srca (1,6 %), možganska krvavitev (1,6 %), krvavitev v znotrajlobanjskem tumorju (0,7 %)*, PRES / RPLS (0,2 %)* in odpoved jeter (0,2 %)* (z zvezdicami označene pogostnosti so iz skupine bolnikov z DTC).
Reactions that occurred at an incidence of ≥2.0% were: epistaxis (22.6%), haematuria (4.8%), haematoma (3.2%), and gastric haemorrhage (3.2%). 
Neželeni učinki, ki so se pojavili z incidenco ≥ 2,0 %, so bili: epistaksa (22,6 %), hematurija (4,8 %), hematom (3,2 %) in želodčna krvavitev (3,2 %).
≥ 2 gm / 24 hours 
≥ 2 g/24 ur prekinite
Kisplyx may cause side effects that can affect your ability to drive or use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Kisplyx lahko povzroči neželene učinke, ki lahko vplivajo na vašo sposobnost upravljanja vozil ali strojev.
Amongst 1,166 patients treated with lenvatinib, there were 5 cases (0.4%) of arterial thromboembolisms (3 cases of myocardial infarction and 2 cases of cerebrovascular accident) with a fatal outcome. 
Med 1166 bolniki, zdravljenimi z lenvatinibom, je bilo 5 primerov (0,4 %) arterijskih trombembolij (3 primeri miokardnega infarkta in 2 primera cerebrovaskularnega insulta) s smrtnim izidom.
However in DTC 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. 
Bolniki z DTC in majhno telesno maso (< 60 kg) pa so imeli večjo incidenco PPE, proteinurije, hipokalciemije in hiponatriemije stopnje 3 ali 4 in nagnjenost k večji incidenci zmanjšanega apetita stopnje 3 ali 4.
Within each frequency category, undesirable effects are presented in order of decreasing seriousness. 
(ni mogoče oceniti iz razpoložljivih podatkov) V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Reactions of Grade 3 or higher (including 1 reaction of Grade 4) occurred in 44.4% of lenvatinib-treated patients compared with 3.8% of placebo-treated patients. 
Učinki stopnje 3 ali višje (vključno z 1 učinkom stopnje 4) so se pojavili pri 44,4 % bolnikov, zdravljenih z lenvatinibom, v primerjavi s 3,8 % bolnikov, ki so prejemali placebo.
Grade 3 reactions occurred in 10.7% of lenvatinib-treated patients and none in placebo-treated patients. 
Učinki stopnje 3 so se pojavili pri 10,7 % bolnikov, zdravljenih z lenvatinibom, in pri nobenem od bolnikov, ki so prejemali placebo.
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. 
Farmakokinetiko lenvatiniba po enkratnem 24-miligramskem odmerku so ovrednotili pri 6 preiskovancih z blago, 6 preiskovancih z zmerno in 6 preiskovancih s hudo okvaro ledvic in rezultate primerjali z 8 zdravimi, demografsko podobnimi preiskovanci.
In the placebo group 0.8% of patients developed renal failure or impairment (0.8% were Grade ≥ 3). 
skupini s placebom se je odpoved ali okvara ledvic razvila pri 0,8 % bolnikov (0,8 % jih je bilo stopnje ≥ 3).
In RCC, patients with baseline renal impairment had a higher incidence of Grade 3 fatigue. 
Bolniki z RCC in izhodiščno okvaro ledvic so imeli večjo incidenco utrujenosti stopnje 3.
In the DTC study, events of gastrointestinal perforation or fistula were reported in 1.9% of lenvatinib-treated patients and 0.8% of patients in the placebo group. 
V študiji DTC so o dogodkih gastrointestinalne perforacije ali fistule poročali pri 1,9 % bolnikov, zdravljenih z lenvatinibom, in pri 0,8 % bolnikov v skupini s placebom.
However, in DTC, patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration. 
Vendar pa so bile pri bolnikih z DTC, starih 75 let ali več, verjetnejše hipertenzija, proteinurija, zmanjšan apetit in dehidracija stopnje 3 ali 4.
In patients with DTC, 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. 
Pri bolnikih z DTC so imele ženske pogosteje hipertenzijo (vključno s hipertenzijo stopnje 3 ali 4), proteinurijo in PPE, moški pa so imeli večje incidenco zmanjšane iztisne frakcije, gastrointestinalnih perforacij in nastanka fistul.
How to take Kisplyx 
Kako jemati zdravilo Kisplyx
• Do not breast-feed if you are taking Kisplyx. 
• Ne dojite, če jemljete zdravilo Kisplyx.
10 mg orally once daily One 10 mg capsule 
10 mg peroralno enkrat na dan ena 10 mg kapsula
The incidence of QTc interval greater than 500 ms was 6% in the lenvatinib plus everolimus-treated group. 
Incidenca intervala QTc, daljšega od 500 ms, je bila 6 % v skupini, zdravljeni z lenvatinibom in everolimusom.
However, in DTC Asian patients had a higher incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, thrombocytopenia, and blood thyroid stimulating hormone increased. 
Vendar pa so imeli bolniki azijske rase z DTC večjo incidenco perifernih edemov, hipertenzije, utrujenosti, PPE, proteinurije, trombocitopenije in zvišanega tirotropnega hormona v krvi kot bolniki bele rase.
Reactions that occurred at an incidence of ≥0.75% above placebo were: epistaxis (11.9%), haematuria (6.5%), contusion (4.6%), gingival bleeding (2.3%), haematochezia (2.3%), rectal haemorrhage (1.5%), haematoma (1.1%), haemorrhoidal haemorrhage (1.1%), laryngeal haemorrhage (1.1%), petechiae (1.1%), and intracranial tumour haemorrhage (0.8%). 
Učinki, ki so se pojavljali z incidenco ≥ 0,75 % več kot pri placebu, so bili: epistaksa (11,9 %), hematurija (6,5 %), kontuzija (4,6 %), gingivalna krvavitev (2,3 %), hematohezija (2,3 %), rektalna krvavitev (1,5 %), hematom (1,1 %), hemoroidna krvavitev (1,1 %), laringealna krvavitev (1,1 %), petehije (1,1 %) in krvavitev v znotrajlobanjskem tumorju (0,8 %).
Blood alkaline phosphatase increased Hepatic function abnormal Gamma-glutamyltransferase increasedk Blood bilirubin increased‡ 
zvišana alkalna fosfataza v krvi abnormalna funkcija jeter zvišana gamaglutamiltransferazak zvišan bilirubin v krvi‡
In patients with severe (Child-Pugh C) hepatic impairment, the recommended starting dose of lenvatinib is 10 mg taken once daily in combination with the dose of everolimus recommended for patients with severe hepatic impairment in the everolimus SmPC. 
Pri bolnikih s hudo (Child-Pugh C) okvaro jeter je priporočeni začetni odmerek lenvatiniba 10 mg enkrat na dan v kombinaciji z odmerkom everolimusa, ki je v SmPC everolimusa priporočen za bolnike s hudo okvaro jeter.
• severe pain in the upper left part of the belly (abdomen) which may be associated with fever, chills, 
• močna bolečina v zgornjem levem delu trebuha (abdomna), ki jo lahko spremljajo zvišana telesna temperatura, mrzlica, slabost in bruhanje,
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. 
Pri bolnikih z normalnim TSH v izhodišču so ugotovili poizhodiščno zvišanje ravni TSH nad 0,5 me./l pri 57 % bolnikov, zdravljenih z lenvatinibom, v primerjavi s 14 % bolnikov, ki so prejemali placebo.
PRES, also known as RPLS, has been reported in patients treated with lenvatinib (<1%; see section 4.8, Description of selected adverse reactions). 
O PRES, znanem tudi kot RPLS, so poročali pri bolnikih, zdravljenih z lenvatinibom (< 1 %; glejte poglavje 4.8, Opis izbranih neželenih učinkov).
In the everolimus monotherapy group 2.0% of patients developed renal failure (2.0% were Grade 3). 
V skupini z monoterapijo z everolimusom se je pri 2,0 % bolnikov razvila odpoved ledvic (2,0 % jih je bilo stopnje 3).
Women of childbearing potential/ Contraception in females 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. 
Ženske v rodni dobi naj med zdravljenjem z lenvatinibom in še vsaj en mesec po končanem zdravljenju ne zanosijo in naj uporabljajo zelo učinkovito kontracepcijo.
Hypokalaemia Decreased appetite Weight decreased 
hipokaliemija zmanjšan apetit hujšanje dehidracija hipomagneziemijab
Amongst 1,166 patients treated with lenvatinib, Grade 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.3%) had a Grade 4 haemorrhage and 5 patients (0.4%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial tumour haemorrhage, haemoptysis and tumour haemorrhage. 
Med 1166 bolniki, zdravljenimi z lenvatinibom, so poročali o krvavitvi stopnje 3 ali višje stopnje pri 2 % bolnikov, 3 bolniki (0,3 %) so imeli krvavitve stopnje 4, 5 bolnikov (0,4 %) pa je imelo neželeni učinek stopnje 5, vključno z arterijsko krvavitvijo, hemoragično možgansko kapjo, krvavitvijo v znotrajlobanjskem tumorju, hemoptizo in krvavitvijo v tumorju.
Liver-related reactions led to dose interruptions and reductions in 1.6% and 1.6% of patients, respectively, and to permanent discontinuation in 3.2% of patients. 
Z jetri povezani neželeni učinki so povzročili prekinitev odmerjanja pri 1,6 % bolnikov, zmanjšanje odmerka pri 1,6 % bolnikov, trajno ukinitev pa pri 3,2 % bolnikov.
The primary efficacy outcome measure, based on investigator assessed tumour response, was progression-free survival (PFS) of the lenvatinib plus everolimus arm vs the everolimus arm and of the lenvatinib arm vs the everolimus arm. Other efficacy outcome measures included overall survival (OS) and investigator-assessed objective response rate (ORR). 
Glavno merilo izida učinkovitosti na podlagi odziva tumorja, ki ga je ocenil raziskovalec, je bilo preživetje brez napredovanja bolezni (progression-free survival - PFS) skupine z lenvatinibom in everolimusom proti skupini z everolimusom in skupine z lenvatinibom proti skupini z everolimusom.
In the DTC study (see Lenvima SmPC), the most commonly reported liver-related adverse reactions were hypoalbuminaemia (9.6% lenvatinib vs. 1.5% placebo) and elevations of liver enzyme levels, including increases in alanine aminotransferase (7.7% lenvatinib vs. 0 placebo), aspartate aminotransferase (6.9% lenvatinib vs. 1.5% placebo), and blood bilirubin (1.9% lenvatinib vs. 0 placebo). 
V študiji DTC (glejte SmPC za zdravilo Lenvima) so bili z jetri povezani neželeni učinki, o katerih so najpogosteje poročali, hipoalbuminemija (9,6 % lenvatinib proti 1,5 % placebo) in zvišanje ravni jetrnih encimov, vključno z zvišanjem alanin-aminotransferaze (7,7 % lenvatinib proti 0 placebo), aspartat-aminotransferaze (6,9 % lenvatinib proti 1,5 % placebo) in bilirubina v krvi (1,9 % lenvatinib proti 0 placebo).
Lymphopenia includes lymphopenia and decreased lymphocyte count. 
Limfopenija vključuje limfopenijo in zmanjšano število limfocitov.
In the RCC study (see section 5.1), the most commonly reported liver-related adverse reactions in the lenvatinib plus everolimus-treated group were elevations of liver enzyme levels, including increases in alanine aminotransferase (9.7%), aspartate aminotransferase (4.8%), alkaline phosphatase (4.8%), and blood bilirubin (3.2%). 
V študiji RCC (glejte poglavje 5.1) so bili v skupini, zdravljeni z lenvatinibom in everolimusom, neželeni učinki, povezani z jetri, o katerih so najpogosteje poročali, zvišanja ravni jetrnih encimov, vključno z zvišanjem alanin-aminotransferaze (9,7 %), aspartat-aminotransferaze (4,8 %), alkalne fosfataze (4,8 %) in bilirubina v krvi (3,2 %).
Lenvatinib may adversely affect the wound healing process as do other agents of the same class. 
Lenvatinib, tako kot druga zdravila iste skupine, lahko neugodno vpliva na proces celjenja ran.
Grade 3 
driska stopnja 3
Hypothyroidism** Blood thyroid stimulating hormone increased‡** 
Bolezni endokrinega sistema hipotiroidizem** zvišan tirotropni hormon v krvi‡**
• The recommended daily dose of Kisplyx is 18 mg once a day (one 10 mg capsule and two 4 mg capsules) in combination with one 5 mg tablet of everolimus once a day. 
• Priporočeni odmerek zdravila Kisplyx je 18 mg enkrat na dan (1 kapsula po 10 mg in 2 kapsuli po 4 mg) skupaj z eno 5-miligramsko tableto everolimusa enkrat na dan.
Liver-related reactions of Grade 3 or higher (including 1 Grade 5 case of hepatic failure) occurred in 5.4% of lenvatinib-treated patients compared with 0.8% in placebo-treated patients. 
Z jetri povezani učinki stopnje 3 ali višje (vključno z 1 primerom odpovedi jeter stopnje 5) so se pojavili pri 5,4 % bolnikov, zdravljenih z lenvatinibom, v primerjavi z 0,8 % pri bolnikih, ki so prejemali placebo.
In DTC, patients with baseline hypertension had a higher incidence of Grade 3 or 4 hypertension, proteinuria, diarrhoea, and dehydration, and experienced more serious cases of dehydration, hypotension, pulmonary embolism, malignant pleural effusion, atrial fibrillation, and GI symptoms (abdominal pain, diarrhoea, vomiting). 
Pri DTC so imeli bolniki z izhodiščno hipertenzijo večjo incidenco hipertenzije, proteinurije, driske in dehidracije stopnje 3 ali 4, med njimi je bilo tudi več resnih primerov dehidracije, hipotenzije, pljučne embolije, malignega plevralnega izliva, atrijske fibrilacije in gastrointestinalnih simptomov (bolečina v trebuhu, driska, bruhanje).
The recommended daily dose of lenvatinib is 18 mg (one 10 mg capsule and two 4 mg capsules) once daily in combination with 5 mg of everolimus once daily. 
Priporočeni dnevni odmerek lenvatiniba je 18 mg (ena 10-miligramska kapsula in dve 4-miligramski kapsuli) v kombinaciji s 5 mg everolimusa enkrat na dan.
No reports of QTc interval prolongation greater than 500 ms or increases greater than 60 ms occurred in the everolimus-treated group. 
V skupini, zdravljeni z everolimusom, ni bilo poročil o podaljšanju intervala QTc, daljšem od 500 ms, ali podaljšanju za več kot 60 ms.
Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, the platelet derived growth factor (PDGF) receptor PDGFRα, KIT, and RET. 
Lenvatinib je inhibitor receptorjev tirozin-kinaze (RTK), ki selektivno inhibira kinazne aktivnosti receptorjev rastnega faktorja vaskularnega endotelija (vascular endothelial growth factor ali VEGF) VEGFR1 (FLT1), VEGFR2 (KDR) in VEGFR3 (FLT4), poleg drugih RTK, povezanih z drugimi proangiogenimi in onkogenimi potmi, vključno z receptorji za fibroblastni rastni faktor (fibroblast growth factor ali FGF) FGFR1, 2, 3 in 4, receptorjem za rastni faktor iz trombocitov (platelet derived growth factor ali PDGF) PDGFRα, KIT in RET. Kombinacija lenvatiniba in everolimusa je pokazala zvečanje antiangiogene in antitumorske aktivnosti, kar dokazuje zmanjšanje proliferacije humanih endotelijskih celic, nastajanja tubulov in signaliziranja z VEGF in vitro in volumna tumorjev v mišjih modelih ksenotransplantacije humanega raka ledvičnih celic, ki je bilo večje kot pri vsakem zdravilu posebej.
There were no reports in the lenvatinib plus everolimus or everolimus monotherapy groups. 
V skupini z lenvatinibom in everolimusom ter v skupini z monoterapijo z everolimusom ni bilo poročil.
Renal failure and impairment (see section 4.4) 
Odpoved ledvic in okvara ledvic (glejte poglavje 4.4)
For previously normotensive subjects, monotherapy with one of the classes of antihypertensive should be started when elevated BP is observed. 
Pri predhodno normotenzivnih osebah je treba takrat, ko opazimo zvišan krvni tlak, začeti z monoterapijo z eno od skupin antihipertenzivnih zdravil.
Each carton contains 30, 60, or 90hard capsules.Not all pack sizes may be marketed. 
Ena kartonska škatla vsebuje 30, 60 ali 90 trdih kapsul.
Nephrotic syndrome 
nefrotični sindrom ------