natgillin/translations-raw huggingface dataset:
The SELECT study was a multicentre, randomised, double-blind, placebo-controlled trial that was conducted in 392 patients with radioiodine-refractory differentiated thyroid cancer with independent, centrally reviewed, radiographic evidence of disease progression within 12 months (+1 month window) prior to enrolment.
Ispitivanje SELECT bilo je multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno u 392 bolesnika s diferenciranim rakom štitnjače refraktornim na radioaktivni jod i s neovisno, centralno pregledanim radiografskim dokazom progresije bolesti unutar 12 mjeseci (u rasponu od +1 mjesec) prije uključenja.
Patients with ≥50% liver occupation, clear invasion into the bile duct or a main branch of the portal vein (Vp4) on imaging were also excluded.
Isključeni su i bolesnici s jetrom zahvaćenom ≥ 50%, jasnom invazijom u žučovod ili glavne grane portalne vene (Vp4) na snimci.
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.
Stupanj invazije/infiltracije tumora u velike krvne žile (npr. karotidnu arteriju) treba uzeti u obzir zbog mogućeg rizika od teškog krvarenja povezanog sa smanjenjem veličine/nekrozom tumora nakon terapije lenvatinibom.
• weigh less than 60 kg
• imate tjelesnu težinu manju od 60 kg
Continue lenvatinib and initiate antihypertensive therapy, if not already receiving
Nastavite s lenvatinibom i uvedite antihipertenzivnu terapiju, ako je bolesnik već ne uzima
Patients with hypertension
Bolesnici s hipertenzijom
Your doctor can give you medicine to reduce these side effects.
Liječnik Vam može dati lijek koji će ublažiti te nuspojave.
Lenvatinib is not a substrate for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, MATE1, MATE2-K or the bile salt export pump BSEP.
Lenvatinib nije supstrat OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, MATE1, MATE2-K ili pumpe za izbacivanje žučnhi soli BSEP-a.
The choice of antihypertensive treatment should be individualised to the patient's clinical circumstances and follow standard medical practice.
Izbor antihipertenzivnog liječenja treba biti prilagođen pojedinom bolesniku prema kliničkim okolnostima, te u liječenju treba slijediti standardnu medicinsku praksu.
Symptoms and Management
Simptomi i liječenje
• Prior treatments: hepatectomy (28%), radiotherapy (11%), loco-regional therapies including transarterial (chemo)embolisation (52%), radiofrequency ablation (21%) and percutaneous ethanol injection (4%)
• Prethodna liječenja: hepatektomija (28%), radioterapija (11%), loko-regionalne terapije uključujući transarterijsku (kemo)embolizaciju (52%), radiofrekvencijsku ablaciju (21%) i perkutanu injekciju etanola (4%)
In vitro binding of lenvatinib to human plasma proteins is high and ranged from 98% to 99% (0.3 - 30 μg/mL, mesylate).
In vitro, lenvatinib se u visokom postotku veže za proteine ljudske plazme i to u rasponu od 98% do 99% (0,3 - 30 μg/ml, mesilat).
Further dose adjustments may be necessary based on individual tolerability.
Mogu biti potrebne daljnje prilagodbe doze na temelju podnošljivosti u pojedinog bolesnika.
Lenvatinib and its metabolites are excreted in rat milk.
Lenvatinib i njegovi metaboliti izlučuju se u mlijeku štakora.
There have also been reports of overdose with lenvatinib involving single administrations of 6 to 10 times the recommended daily dose.
Također su zabilježeni slučajevi predoziranja lenvatinibom koji su uključivali primjenu pojedinačne doze 6 do 10 puta veće od preporučene dnevne doze.
In case of suspected overdose, lenvatinib should be withheld and appropriate supportive care given as required.
U slučaju sumnje na predoziranje, potrebno je prekinuti primjenu lenvatiniba i po potrebi primijeniti odgovarajuću potpornu njegu.
Life-threatening toxicities (Grade 4): Discontinuee a.
Po život opasne toksičnosti (stupanj 4): Trajni prekide a.
4.7 Effects on ability to drive and use machines Lenvatinib has a minor influence on the ability to drive and use machines, due to undesirable effects such as fatigue and dizziness.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Lenvatinib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog nuspojava kao što su umor i omaglica.
A treatment decision should be made based upon an assessment of the individual patient's benefit/risk.
Odluku o liječenju treba temeljiti na procjeni omjera koristi i rizika u pojedinog bolesnika.
Cases of fatal intracranial haemorrhage have been reported in some patients with or without brain metastases.
Slučajevi smrtonosnog intrakranijalnog krvarenja zabilježeni su u nekih bolesnika s metastazama u mozgu ili bez njih.
The positive effect on PFS was seen across the subgroups of age (above or below 65 years), sex, race, histological subtype, geographic region, and those who received 0 or 1 prior VEGF/VEGFR-targeted therapies.
Pozitivan učinak na PFS uočen je u različitim podskupinama razdijeljenim prema dobi (iznad i ispod 65 godina), spolu, rasi, histološkom podtipu i geografskoj regiji i onima koji su prethodno primili 0 ili 1 terapiju usmjerenu na VEGF/VEGFR.
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.
Analogni medijan prividnog volumena distribucije u stanju dinamičke ravnoteže (Vz/Fss) također je većinom bio dosljedan i kretao se u rasponu od 43,2 l do 121 l.
Kaplan-Meier Curve of Progression-Free Survival - DTC
Slika 1 Kaplan-Meierova krivulja preživljenja bez progresije bolesti - DTC
Number of capsules
Broj kapsula
The median time to first onset was 11.9 weeks.
Medijan vremena do prve pojave bio je 11,9 tjedana.
Resolves to Grade 0, 1 or See detailed guidance in Table 4 in section 4.4.
Detaljne smjernice vidjeti u tablici 4 u dijelu 4.4.
Hypertension includes: hypertension, hypertensive crisis, increased diastolic blood pressure , , orthostatic hypertension, and increased blood pressure.
Hipertenzija uključuje: hipertenziju, hipertenzivnu krizu, povišen dijastolički krvni tlak, ortostatsku hipertenziju i povišen krvni tlak.
M2' and M3', the major metabolites in human faeces, were formed from M2 and lenvatinib, respectively, by aldehyde oxidase.
M2' i M3', glavni metaboliti u ljudskoj stolici, nastali su iz M2 odnosno lenvatiniba djelovanjem aldehid oksidaze.
Lenvatinib dose should be interrupted or dose adjusted as necessary depending on severity, presence of ECG changes, and persistence of hypocalcaemia.
Primjenu lenvatiniba treba privremeno prekinuti ili prilagoditi dozu prema potrebi, ovisno o težini, prisutnosti promjena u EKG-u i ustrajnosti hipokalcemije.
The highest doses of lenvatinib studied clinically were 32 mg and 40 mg per day.
Najviše klinički ispitane doze lenvatiniba bile su 32 mg i 40 mg na dan.
In plasma samples collected up to 24 hours after administration, lenvatinib constituted 97% of the radioactivity in plasma radiochromatograms while the M2 metabolite accounted for an additional 2.5%.
U uzorcima plazme prikupljenima do 24 sata nakon primjene, lenvatinib je činio 97% radioaktivnosti u radiokromatogramima plazme, dok je metabolit
A clinical drug-drug interaction (DDI) study in cancer patients showed that plasma concentrations of midazolam (a sensitive CYP3A and Pgp substrate) were not altered in the presence of lenvatinib.
Kliničko ispitivanje interakcija lijek-lijek (engl. drug-drug interaction, DDI) u bolesnika s karcinomom pokazalo je da se koncentracije midazolama u plazmi (supstrat osjetljiv na CYP3A i Pgp) nisu mijenjale u prisutnosti lenvatiniba.
Radioiodine-refractory was defined as one or more measurable lesions either with a lack of iodine uptake or with progression in spite of radioactive-iodine (RAI) therapy, or having a cumulative activity of RAI of >600 mCi or 22 GBq with the last dose at least 6 months prior to study entry.
Refraktornost na radioaktivni jod bila je definirana kao jedna ili više mjerljivih lezija bez unosa joda ili s progresijom unatoč terapiji radioaktivnim jodom (RAI) ili kumulativna aktivnost RAI od >600 mCi ili 22 GBq sa zadnjom dozom najmanje 6 mjeseci prije ulaska u ispitivanje.
Patients in the placebo arm could opt to receive lenvatinib treatment at the time of confirmed disease progression.
Bolesnici u skupini koja je primala placebo mogli su se odlučiti za liječenje lenvatinibom u vrijeme kada je potvrđena progresija bolesti.
Hepatic encephalopathyl,‡,†
hepatička encefalopatijal,‡,†
Men had a higher incidence (26.5%) of dysphonia than women (12.3%), decreased weight and decreased platelet count.
U muškaraca je bila veća incidencija (26,5%) disfonije nego u žena (12,3%), smanjene tjelesne težine i smanjenog broja trombocita.
LENVIMA can also be used on its own to treat liver cancer (hepatocellular carcinoma) in adults who have not previously been treated with another anticancer medicine that travels through the bloodstream.
LENVIMA se može također primjenjivati sama za liječenje raka jetre (hepatocelularni karcinom) u odraslih koji nisu prethodno liječeni drugim lijekom protiv raka, koji se krvotokom raspodjeljuje po čitavom tijelu.
Women of childbearing potential must use highly effective contraception while taking lenvatinib and for one month after stopping treatment (see section 4.6).
Žene reproduktivne dobi moraju koristiti visoko učinkovitu kontracepciju dok uzimaju lenvatinib i tijekom 1 mjeseca nakon prekida liječenja (vidjeti dio 4.6).
PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances.
PRES je neurološki poremećaj koji se može manifestirati glavoboljom, napadajem, letargijom, smetenošću, promijenjenom mentalnom funkcijom, sljepoćom i drugim vidnim ili neurološkim poremećajima.
Patients with HCC should be monitored for worsening liver function including hepatic encephalopathy.
Potrebno je pratiti bolesnike sa HCC-om da ne dođe do pogoršanja funkcije jetre, uključujući hepatičku encefalopatiju.
Neutropenia includes neutropenia and decreased neutrophil count decreased.
Neutropenija uključuje neutropeniju i smanjeni broj neutrofila.
The overall survival analysis was confounded by the fact that placebo-treated subjects with confirmed disease progression had the option to cross over to open-label lenvatinib.
Na analizu ukupnog preživljenja utjecao je jedan zbunjujući čimbenik, a taj je činjenica da su ispitanici s potvrđenom progresijom bolesti koji su primali placebo imali mogućnost prijeći na otvoreno liječenje lenvatinibom.
Patients were excluded who had prior systemic anticancer therapy for advanced/unresectable HCC or any prior anti-VEGF therapy.
Isključeni su bolesnici koji su prethodno primali sistemsku terapiju protiv raka za uznapredovali/neoperabilni HCC ili bilo koju prethodnu anti-VEGF terapiju.
These in vivo metabolic routes align with the data provided in the in vitro studies using human biomaterials.
Ovi in vivo metabolički putevi sukladni su podacima dobivenima in vitro u ispitivanjima na ljudskom biološkom materijalu.
There is no specific antidote for overdose with lenvatinib.
Ne postoji posebni antidot za predoziranje lenvatinibom.
Data from a human mass balance/excretion study indicate lenvatinib is extensively metabolised in humans.
Podaci iz ispitivanja masene bilance/izlučivanja u ljudi pokazuju da se lenvatinib u ljudi opsežno metabolizira.
Systolic BP ≥140 mmHg up to <160 mmHg or diastolic BP ≥90 mmHg up to <100 mmHg
Sistolički krvni tlak ≥140 mmHg do <160 mmHg ili dijastolički krvni tlak ≥90 mmHg do <100 mmHg
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.
U bolesnika se medijan prividnog volumena distribucije (Vz/F) prve doze kretao u rasponu od 50,5 l do 92 l i većinom je bio dosljedan u svim doznim skupinama od 3,2 mg do 32 mg.
Lenvatinib may adversely affect the wound healing process as for other agents of the same class.
Lenvatinib može štetno utjecati na cijeljenje rana kao i drugi lijekovi istoga razreda.
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.
Za otapanje, ulijte žlicu vode ili soka od jabuke u malu čašu i stavite kapsule u tekućinu bez lomljenja ili drobljenja.
If patients have severe renal impairment, the initial dose of lenvatinib should be adjusted (see sections 4.2 and 5.2).
Ako bolesnici imaju teško oštećenje funkcije bubrega, potrebno je prilagoditi početnu dozu lenvatiniba (vidjeti dijelove 4.2 i 5.2).
Grade 4*
4. stupnja*
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).
Na temelju analize populacijske farmakokinetike u bolesnika koji su primali do 24 mg lenvatiniba jedanput na dan, dob, spol, tjelesna težina i rasa (Japanci naspram drugih, bijelci naspram drugih) nisu imali značajne učinke na klirens (vidjeti dio 4.2).
Based on AUC(0 - inf), lenvatinib accounted for 60% and 64% of the total radioactivity in plasma and blood, respectively.
Na temelju vrijednosti AUC(0 - inf), na lenvatinib je otpalo 60% radioaktivnosti u plazmi i 64% radioaktivnosti u krvi.
In vitro, the lenvatinib blood-to-plasma concentration ratio ranged from 0.589 to 0.608 (0.110 μg/mL, mesylate).
In vitro, omjer koncentracije lenvatiniba u krvi i plazmi bio je u rasponu od 0,589 do 0,608 (0,110 μg/ml, mesilat).
A statistically significant prolongation in PFS was demonstrated in lenvatinib-treated patients compared with those receiving placebo (p<0.0001) (see figure 1).
Dokazano je statistički značajno produljenje preživljenja bez progresije bolesti (PFS) u bolesnika liječenih lenvatinibom u usporedbi s onima koji su primali placebo (p<0,0001) (vidjeti sliku 1).
LENVIMA 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.
LENVIMA blokira djelovanje proteina koji se zovu receptori tirozin kinaze i uključeni su u rast stanica i razvoj novih krvnih žila koje stanice opskrbljuju kisikom i hranjivim tvarima i pomažu njihov rast.
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.
U bolesnika sa solidnim tumorima koji su primali jednu i više doza lenvatiniba jedanput na dan, izloženost lenvatinibu (Cmax i AUC) povećavala se izravno proporcionalno primijenjenoj dozi u rasponu od 3,2 do 32 mg jedanput na dan.
• painful infection or irritation near the anus
• bolna infekcija ili nadraženost u blizini čmara
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).
LENVIMA je indicirana kao monoterapija za liječenje odraslih bolesnika s uznapredovalim ili neoperabilnim hepatocelularnim karcinomom (HCC) koji prethodno nisu primili sistemsku terapiju (vidjeti dio 5.1).
If the submission of a PSUR and the update of an RMP coincide, they can be submitted at the same time.
Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
There was a higher incidence of decreased neutrophil count in patients with HCC (8.7% on lenvatinib than in other nonHCC tumour types (1.4%)), which was not associated with infection, sepsis or bacterial peritonitis.
U bolesnika sa HCC-om bila je veća incidencija smanjenog broja neutrofila (u 8,7% bolesnika koji su primali lenvatinib u odnosu na druge vrste tumora koji nisu HCC (1,4%)), koja nije bila povezana s infekcijom, sepsom ili bakterijskim peritonitisom.
• Do not breast-feed if you are taking LENVIMA.
• Nemojte dojiti ako uzimate LENVIMU.
The daily dose is to be modified as needed according to the dose/toxicity management plan.
Dnevnu dozu treba prilagoditi po potrebi u skladu s planom upravljanja omjerom doze/toksičnosti.
The median half-life was comparable in subjects with mild, moderate, and severe hepatic impairment as well as those with normal hepatic function and ranged from 26 hours to 31 hours.
Medijan poluvijeka bio je usporediv u ispitanika s blagim, umjerenim i teškim oštećenjem funkcije jetre, kao i u onih s normalnom funkcijom jetre, i kretao se u rasponu od 26 sati do 31 sat.
• diarrhoea, feeling and being sick - these are very common side effects that can become serious if they cause you to become dehydrated, which can lead to kidney failure.
• proljev, mučnina i povraćanje - to su vrlo česte nuspojave koje mogu postati ozbiljne ako dovedu do dehidracije, koja može uzrokovati zatajenje bubrega.
LENVIMA is a medicine that contains the active substance lenvatinib.
LENVIMA je lijek koji sadrži djelatnu tvar lenvatinib.
Lenvatinib is rapidly absorbed after oral administration with tmax typically observed from 1 to 4 hours postdose.
Lenvatinib se brzo apsorbira nakon peroralne primjene, s tmax obično primijećenim od 1 do 4 sata nakon doze.
Dose adjustments and Discontinuation for HCC
Prilagodbe doze i prekid liječenja za HCC
Increased alanine aminotransferase ‡
hipoalbuminemijaj,‡ povišena alanin aminotransferaza‡ povišena aspartat aminotransferaza‡
This binding was mainly to albumin with minor binding to α1-acid glycoprotein and γ-globulin.
Uglavnom se veže za albumin, a u manjoj mjeri za α1-kiseli glikoprotein i γ-globulin.
The daily dose is to be modified, as needed, according to the dose/toxicity management plan.
Dnevnu dozu treba prilagoditi, po potrebi, u skladu s planom upravljanja omjerom doze/toksičnosti.
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.
Medijan vremena do objektivnog odgovora iznosio je 2,0 (95% CI: 1,9-3,5) mjeseca; međutim, među bolesnicima koji su imali potpuni ili djelomični odgovor na lenvatinib, opaženo je da je njih 70,4% razvilo odgovor 30. dan ili unutar 30 dana od uzimanja doze od 24 mg.
Since lenvatinib is mainly eliminated by hepatic metabolism, an increase in exposure in patients with moderate to severe hepatic impairment is expected.
Budući da se lenvatinib uglavnom eliminira putem jetrenog metabolizma, očekuje se povećano izlaganje u bolesnika s umjerenim do teškim oštećenjem funkcije jetre.
m: Hepatocellular damage and hepatitis includes: drug-induced liver injury, hepatic steatosis, and cholestatic liver injury.
m: Hepatocelularno oštećenje i hepatitis uključuju: oštećenje jetre uzrokovano lijekom, steatozu jetre i kolestatsko oštećenje jetre.
Therefore, the decision to resume lenvatinib following a major surgical procedure should be based on clinical judgment of adequate wound healing.
Stoga, odluku o nastavku davanja lenvatiniba nakon velikih kirurških zahvata treba donositi na temelju kliničke prosudbe primjerenog cijeljenja rane.
Most reactions resolved following supportive treatment, without dose interruption or reduction, which occurred in 1.5% and 1.1% of patients, respectively; 1 patient with Grade 4 hypocalcaemia discontinued treatment permanently.
Većina se nuspojava povukla nakon potpornog liječenja, bez privremenog prekida primjene ili sniženja doze, što se dogodilo u 1,5% odnosno 1,1% bolesnika; 1 bolesnik s hipokalcemijom 4. stupnja trajno je prekinuo liječenje.
There was also a case of acute hepatitis in a patient without liver metastases.
Bio je i jedan slučaj akutnog hepatitisa u bolesnika bez jetrenih metastaza.
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.
Svi bolesnici, osim onih s teškim oštećenjem funkcije jetre ili bubrega (vidjeti niže), trebaju započeti liječenje preporučenom dozom od 24 mg, nakon čega dozu treba dodatno prilagoditi na temelju podnošljivosti u pojedinog bolesnika.
Following independent review confirmation of disease progression, 109 (83.2%) patients randomised to placebo had crossed over to open-label lenvatinib at the time of the primary efficacy analysis.
Nakon što je neovisnim pregledom potvrđena progresija bolesti, 109 (83,2%) bolesnika randomiziranih u skupinu koja je primala placebo prešlo je na otvoreno liječenje lenvatinibom u vrijeme primarne analize djelotvornosti.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile.
Carcinogenicity studies have not been conducted with lenvatinib.
Nisu provedena ispitivanja kancerogenosti lenvatiniba.
• have a history of abnormal connections (known as a fistula) between different organs in the body or from an organ to the skin
• ste imali stvaranje neprirodnih spojeva (poznatih pod nazivom fistula) između različitih organa u tijelu ili između nekog organa i kože
• feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy - these may be signs of a stroke, bleeding on your brain, or the effect on your brain of a severe increase in blood pressure.
• osjećaj utrnulosti ili slabosti na jednoj strani tijela, jaka glavoblja, napadaj, smetenost, otežan govor, promjene vida ili osjećaj omaglice - to mogu biti znakovi moždanog udara, krvarenja u mozak ili učinka jako povišenog krvnog tlaka na mozak
Lenvatinib dose interruption due to hypocalcaemia occurred in one subject (0.2%) and there were no dose reductions or discontinuations.
Do privremenog prekida doziranja lenvatiniba zbog hipokalcemije došlo je u jednog ispitanika (0,2%), a nije bilo smanjenja doze ili trajnog prekida liječenja.
Lenvatinib was embryotoxic and teratogenic when administered to rats and rabbits (see section 5.3).
Lenvatinib je bio embriotoksičan i teratogen kad se primjenjivao u štakora i kunića (vidjeti dio 5.3).
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0: 63%, ECOG PS of
• Ocjena općeg stanja prema ECOG (ECOG PS) 0: 63%, ECOG PS 1: 37%
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).
U takvih bolesnika lenvatinib treba primjenjivati s oprezom, s obzirom na smanjenu podnošljivost lenvatiniba u bolesnika azijatskog porijekla i starijih bolesnika (vidjeti dio 4.8, Druge posebne populacije).
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).
Čini se da bolesnici u dobi od ≥75 godina, azijatske rase, s komorbiditetima (kao što su hipertenzija i oštećenje funkcije jetre ili bubrega) ili tjelesne težine manje od 60 kg slabije podnose lenvatinib (vidjeti dio 4.8, Druge posebne populacije).
Lenvatinib is a multikinase inhibitor which has shown mainly antiangiogenic properties in vitro and in vivo, and direct inhibition of tumour growth was also observed in in vitro models.
Lenvatinib je inhibitor više kinaza koji pokazuje uglavnom antiangiogena svojstva in vitro i in vivo te izravnu inhibiciju rasta tumora u modelima in vitro.
Resolves to Grade 0-1.
Povlači se na 0.-1. stupanj.
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%.
Histološki, 66,1% bolesnika imalo je potvrđenu dijagnozu papilarnog raka štitnjače, a 33,9% imalo je folikularni rak štitnjače koji je uključivao Hürthleove stanice u 14,8% i svijetle stanice u 3,8% bolesnika.