FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Odpornost proti radioaktivnemu jodu je bila opredeljena kot ena ali več merljivih lezij bodisi brez privzema joda bodisi z napredovanjem bolezni kljub zdravljenju z radioaktivnim jodom (RAI) ali s kumulativno aktivnostjo RAI > 600 mCi ali 22 GBq z zadnjim odmerkom vsaj 6 mesecev pred vključitvijo v študijo.
English: Men had a higher incidence (26.5%) of dysphonia than women (12.3%), decreased weight and decreased platelet count.
Slovenian: Moški pa so imeli večje incidenco (26,5 %) hripavosti kot ženske (12,3 %), hujšanja in zmanjšanja števila trombocitov.
English: Similar adverse reactions were observed in clinical trials in DTC and HCC.
Slovenian: Neželeni učinki, ugotovljeni v kliničnih preskušanjih pri DTC in HCC, so bili podobni.
English: BP should be monitored after 1 week of treatment with lenvatinib, then every 2 weeks for the first 2 months, and monthly thereafter.
Slovenian: KT je treba spremljati po 1 tednu zdravljenja z lenvatinibom, nato prva 2 meseca vsaka 2 tedna in zatem enkrat na mesec.
English: • feeling very tired or weak
Slovenian: • močna utrujenost ali šibkost,
English: When systolic BP ≤150 mmHg, diastolic BP ≤95 mmHg, and patient has been on a stable dose of antihypertensive therapy for at least 48 hours, resume lenvatinib at a reduced dose (see section 4.2)
Slovenian: Ko je sistolični KT ≤ 150 mmHg, diastolični KT ≤ 95 mmHg, bolnik pa je že vsaj 48 ur na stabilnem odmerku antihipertenzivne terapije, spet začnite dajati lenvatinib v zmanjšanem odmerku (glejte poglavje 4.2).
English: m: Hepatocellular damage and hepatitis includes: drug-induced liver injury, hepatic steatosis, and cholestatic liver injury.
Slovenian: m: Hepatocelularna poškodba in hepatitis vključujeta: z zdravili povzročeno poškodbo jeter, steatozo jeter in holestatično poškodbo jeter.
English: Reversibility of the toxicologic changes was observed at the end of a 4-week recovery period in all animal species investigated.
Slovenian: Pri vseh raziskovanih živalskih vrstah so opazili reverzibilnost toksikoloških sprememb ob koncu 4-tedenskega obdobja okrevanja.
English: Hypocalcaemia (see section 4.4, QT interval prolongation)
Slovenian: Hipokalciemija (glejte poglavje 4.4 Podaljšanje intervala QT)
English: The Rac in HCC subjects with mild and moderate liver impairment was similar to that reported for other solid tumours.
Slovenian: Vrednost Rac pri bolnikih s HCC z blago in zmerno okvaro jeter je bila podobna vrednosti, ki je bila opisan pri drugih čvrstih tumorjih.
English: Not adjusted for crossover effect.
Slovenian: Brez popravka za učinek prehoda.
English: CI, confidence interval; NE, not estimable; OS, overall survival; PFS, progression-free survival; RPSFT, rank preserving structural failure time model; VEGF/VEGFR, vascular endothelial growth factor / vascular endothelial growth factor receptor.
Slovenian: IZ, interval zaupanja; NE, ni bilo mogoče oceniti; OS, celotno preživetje; PFS, preživetje brez napredovanja bolezni; RPSFT, model ohranjanja ranga strukturnih napak glede na čas; VEGF/VEGFR, rastni faktor vaskularnega endotelija/receptor za rastni faktor vaskularnega endotelija.
English: Blood Pressure (BP) level
Slovenian: Raven krvnega tlaka (KT)
English: Stratified by region (Region 1: Asia-Pacific; Region 2: Western), macroscopic portal vein invasion or extrahepatic spread or both (yes, no), ECOG PS (0, 1) and body weight (<60 kg, ≥60 kg).
Slovenian: b Stratificirano po regijah (regija 1: Azija-Pacifik; regija 2: zahodna), makroskopski invaziji portalne vene ali razširjenosti izven jeter ali oboje (da, ne), ECOG PS (0, 1) in telesni masi
English: • drowsiness, confusion, poor concentration, loss of consciousness that may be signs of liver failure
Slovenian: • utrujenost, zmedenost, slaba koncentracija, izguba zavesti, ki so lahko znaki težav jetrne odpovedi,
English: 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.
Slovenian: Pri bolnikih s HCC je bila večja pojavnost zmanjšanega števila nevtrofilcev (8,7 % pri lenvatinibu v primerjavi z drugimi tipi tumorjev brez HCC (1,4 %)), ki ni bila povezana z okužbo, sepso ali bakterijskim peritonitisom.
English: If you are not sure talk to your doctor before taking LENVIMA.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, preden začnete jemati zdravilo LENVIMA.
English: However, in vivo data indicated that non-P450-mediated pathways contributed to a significant portion of the overall metabolism of lenvatinib.
Slovenian: Vendar so podatki in vivo pokazali, da so presnovne poti, ki ne potekajo preko citokroma P450, prispevale k pomembnemu deležu celotne presnove lenvatiniba.
English: Because it is not known if LENVIMA can reduce the effect of the oral contraceptive pill, if this is your normal method of contraception you should ensure you also add a barrier method such as the cap or condoms if you have sex during treatment with LENVIMA.
Slovenian: Ker ni znano, ali zdravilo LENVIMA lahko zmanjša učinek peroralnih kontracepcijskih tablet, morate v primeru, če je to vaša normalna metoda kontracepcije, zagotoviti, da boste dodatno uporabljali še eno od pregradnih metod kontracepcije, npr. diafragmo ali kondome, če med zdravljenjem z zdravilom LENVIMA spolno občujete.
English: Lenvatinib is not a substrate for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, MATE1, MATE2-K or the bile salt export pump BSEP.
Slovenian: Lenvatinib ni substrat za OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, MATE1, MATE2-K ali izločevalno črpalko žolčnih soli BSEP.
English: 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.
Slovenian: Po potrditvi napredovanja bolezni z neodvisnim pregledom je 109 bolnikov (83,2 %), randomiziranih na placebo, v času primarne analize učinkovitosti prešlo na odprti lenvatinib.
English: • yellow skin or yellowing of the whites of the eyes (jaundice) or drowsiness, confusion, poor concentration - these may be signs of liver problems.
Slovenian: • rumena koža ali porumenelost beločnic (zlatenica) ali zaspanost, zmedenost, slaba koncentracija - to so lahko znaki težav z jetri;
English: 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.
Slovenian: 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.
English: Lenvatinib should not be started in patients with fistula to avoid worsening and lenvatinib should be permanently discontinued in patients with oesophageal or tracheobronchial tract involvement and any Grade 4 fistula (see section 4.2); limited information is available on the use of dose interruption or reduction in management of other events, but worsening was observed in some cases and caution should be taken.
Slovenian: Lenvatiniba ne smemo začeti dajati bolnikom s fistulo, da se izognemo poslabšanju, trajno pa ga moramo ukiniti pri bolnikih s prizadetostjo ezofagealnega ali traheobronhialnega trakta in kakršno koli fistulo stopnje 4 (glejte poglavje 4.2); o uporabi prekinitve ali zmanjšanja odmerjanja za zdravljenje drugih dogodkov je na voljo malo podatkov, vendar so v nekaterih primerih opazili poslabšanje, zato je potrebna previdnost.
English: No adjustment of starting dose is required on the basis of age.
Slovenian: Na podlagi starosti prilagoditev začetnega odmerka ni potrebna.
English: Patients were excluded who had prior systemic anticancer therapy for advanced/unresectable HCC or any prior anti-VEGF therapy.
Slovenian: Bolniki so bili izključeni, če so imeli predhodno sistemsko terapijo proti raku za napredovali/neoperabilni HCC ali katero koli predhodno zdravljenje z zdravili, usmerjenimi proti VEGF.
English: Following administration of radiolabelled lenvatinib to 6 patients with solid tumours, approximately two-thirds and one-quarter of the radiolabel were eliminated in the faeces and urine, respectively.
Slovenian: Po dajanju radioaktivno označenega lenvatiniba 6 bolnikom s čvrstimi tumorji se je približno dve tretjini oziroma ena četrtina radioaktivnega označevalca odstranila iz telesa z blatom oziroma urinom.
English: LENVIMA may cause side effects that can affect your ability to drive or use machines.
Slovenian: Zdravilo LENVIMA lahko povzroči neželene učinke, ki lahko vplivajo na vašo sposobnost upravljanja vozil ali strojev.
English: Posterior reversible encephalopathy syndrome Monoparesis Transient ischaemic attack
Slovenian: sindrom posteriorne reverzibilne encefalopatije monopareza tranzitorna ishemična ataka
English: Data from a human mass balance/excretion study indicate lenvatinib is extensively metabolised in humans.
Slovenian: Podatki iz študije masnega ravnovesja/izločanja pri ljudeh kažejo, da se lenvatinib pri ljudeh intenzivno presnavlja.
English: The objective response rate (complete response [CR] plus partial response [PR]) per independent radiological review was significantly (p<0.0001) higher in the lenvatinib-treated group (64.8%) than in the placebo-treated group (1.5%).
Slovenian: Objektivna odzivnost (popolni odziv [CR] plus delni odziv [PR]) po neodvisnem radiološkem pregledu je bila značilno (p < 0,0001) večja v skupini, zdravljeni z lenvatinibom (64,8 %), kot v skupini, ki je prejemala placebo (1,5 %).
English: In this trial, there was 1 case of fatal intracranial haemorrhage among 16 patients who received lenvatinib and had CNS metastases at baseline.
Slovenian: V tem preskušanju je bil 1 primer smrtne znotrajlobanjske krvavitve med 16 bolniki, ki so prejemali lenvatinib in so v izhodišču imeli zasevke v centralnem živčevju.
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 značilno vplivali na očistek (glejte poglavje 4.2).
English: Liver function tests should be monitored before initiation of treatment, then every 2 weeks for the first 2 months and monthly thereafter during treatment.
Slovenian: Teste funkcije jeter je treba spremljati pred začetkom zdravljenja, med zdravljenjem pa prva 2 meseca vsaka 2 tedna in nato enkrat na mesec.
English: LENVIMA is a medicine that contains the active substance lenvatinib.
Slovenian: LENVIMA je zdravilo, ki vsebuje zdravilno učinkovino lenvatinib.
English: 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.
Slovenian: Večina neželenih učinkov je po podpornem zdravljenju izginila brez prekinitve ali zmanjšanja odmerka, do katerih je prišlo pri 1,5 % oziroma 1,1 % bolnikov; pri enem bolniku s hipokalciemijo stopnje 4 so zdravljenje trajno ukinili.
English: Carcinogenicity studies have not been conducted with lenvatinib.
Slovenian: Študij kancerogenosti za lenvatinib niso opravili.
English: The results for surrogate endpoints (PFS and ORR) are presented in Table 7 below.
Slovenian: Rezultati za nadomestne opazovane dogodke (PFS in objektivno odzivnost) so predstavljeni v preglednici 7 v nadaljevanju.
English: Dose adjustments and discontinuations for DTC
Slovenian: Prilagajanje odmerka in ukinitev pri DTC
English: Pharmacokinetic parameters of lenvatinib have been studied in healthy adult subjects, adult subjects with hepatic impairment, renal impairment, and solid tumours.
Slovenian: Farmakokinetične parametre lenvatiniba so proučevali pri zdravih odraslih preiskovancih, odraslih preiskovancih z okvaro jeter, okvaro ledvic in čvrstimi tumorji.
English: • dry, sore, or inflamed mouth, odd taste sensation
Slovenian: • suha, boleča ali vneta usta, občutek čudnega okusa,
English: Patients with hypertension
Slovenian: Bolniki s hipertenzijo
English: • If it is less than 12 hours until your next dose: skip the missed dose.
Slovenian: • Če do naslednjega odmerka manjka manj kot 12 ur: pozabljeni odmerek izpustite.
English: • dry skin, thickening and itching of the skin
Slovenian: • suha koža, zadebelitev in srbenje kože,
English: The median OS had not been reached for either the lenvatinib group or the placebo crossover group.
Slovenian: Mediano OS ni bilo doseženo niti pri skupini z lenvatinibom niti pri skupini, ki je s placeba prešla na lenvatinib.
English: Hepatic encephalopathy tended to be associated with adverse disease characteristics at baseline or with the use of concomitant medications.
Slovenian: Jetrna encefalopatija je bila večinoma povezana z neugodnimi značilnostmi bolezni v izhodišču ali s sočasno uporabo zdravil.
English: What LENVIMA is and what it is used for What you need to know before you take LENVIMA How to take LENVIMA
Slovenian: Kaj je zdravilo LENVIMA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo LENVIMA Kako jemati zdravilo LENVIMA Možni neželeni učinki
English: The toxicity of lenvatinib was more prominent in younger rats (dosing initiated on PND7) compared with those with dosing initiated on PND21 and mortality and some toxicities were observed earlier in the juvenile rats at 10 mg/kg compared with adult rats administered the same dose level.
Slovenian: Toksičnost lenvatiniba je bila izrazitejša pri mlajših podganah (odmerjanje se je začelo na PND7) kot pri tistih, pri katerih se je odmerjanje začelo na PND21, in so smrtnost in nekatere toksičnosti prej opazili pri mladih podganah pri odmerku 10 mg/kg v primerjavi z odraslimi podganami, ki so prejemale enako raven odmerkov.
English: Other medicines and LENVIMA
Slovenian: Druga zdravila in zdravilo LENVIMA
English: In vitro, cytochrome P450 3A4 was demonstrated as the predominant (>80%) isoform involved in the P450-mediated metabolism of lenvatinib.
Slovenian: In vitro so pokazali, da je citokrom P450 3A4 prevladujoča (> 80 %) izooblika vpletena v presnovo lenvatiniba, ki poteka preko P450.
English: Lenvatinib has not been studied in patients who have had an arterial thromboembolism within the previous 6 months, and therefore should be used with caution in such patients.
Slovenian: Pri bolnikih, ki so imeli v predhodnih 6 mesecih arterijsko trombembolijo, lenvatiniba niso proučevali, zato ga je treba pri takih bolnikih previdno uporabljati.
English: Gastrointestinal toxicity should be actively managed in order to reduce the risk of development of renal impairment or renal failure.
Slovenian: Toksičnost za prebavila je treba aktivno obvladovati, da se zmanjša tveganje nastanka okvare ledvic ali odpovedi ledvic.
English: P-value d
Slovenian: Vrednost pd
English: • If you become pregnant while being treated with LENVIMA, tell your doctor immediately.
Slovenian: • Če med zdravljenjem z zdravilom LENVIMA zanosite, to takoj povejte zdravniku.
English: PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances.
Slovenian: PRES je nevrološka bolezen, ki se lahko kaže z glavobolom, epileptičnim napadom, letargijo, zmedenostjo, spremenjenim duševnim stanjem, slepoto in drugimi motnjami vida ali nevrološkimi motnjami.
English: The capsules must be left in the liquid for at least 10 minutes and stirred for at least 3 minutes to dissolve the capsule shells.
Slovenian: Kapsule pustimo v tekočini vsaj 10 minut in mešamo vsaj 3 minute, da se ovojnica kapsule raztopi.
English: Kaplan-Meier Curve of Progression-Free Survival - DTC
Slovenian: Slika 1 Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni - DTC
English: These patients also had a higher incidence of renal reactions and arterial thromboembolic events.
Slovenian: Ti bolniki so imeli tudi večjo incidenco neželenih učinkov na ledvice in arterijskih tromboemboličnih dogodkov.
English: There was also a case of acute hepatitis in a patient without liver metastases.
Slovenian: Tudi en primer akutnega hepatitisa je nastopil pri bolniku brez metastaz v jetrih.
English: Your doctor may consider stopping LENVIMA if you will be undergoing a major surgical procedure as LENVIMA may affect wound healing.
Slovenian: Zdravnik bo morda razmislil o prekinitvi zdravljenja z zdravilom LENVIMA, če boste imeli večji kirurški poseg, saj zdravilo LENVIMA lahko vpliva na celjenje ran.
English: Cardiac dysfunction
Slovenian: Disfunkcija srca
English: Consider resuming at reduced dose if resolves to Grade 0-1.
Slovenian: Ponoven začetek zdravljenja z zmanjšanim odmerkom pride v poštev, če se izboljša na stopnjo 0-1
English: LENVIMA is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
Slovenian: Zdravilo LENVIMA je indicirano kot monoterapija za zdravljenje odraslih bolnikov s progresivnim, lokalno napredovalim ali metastatičnim, diferenciranim (papilarnim/folikularnim/Hürthle-celičnim) karcinomom ščitnice (DTC - differentiated thyroid carcinoma), odpornim proti radioaktivnemu jodu (RAI - refractory to radioactive iodine).
English: Continue lenvatinib and increase the dose of the current antihypertensive therapy or initiate additional antihypertensive therapy
Slovenian: Nadaljujte z lenvatinibom in zvečajte odmerek trenutnega antihipertenzivnega zdravila ali uvedite dodatno antihipertenzivno zdravilo.
English: Overall Survival Number of deaths (%) Median OS in months (95% CI)
Slovenian: Celotno preživetje število smrti (%) mediano OS v mesecih (95 % IZ)
English: 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.
Slovenian: Izključeni so bili tudi bolniki s prisotnostjo karconoma v ≥ 50 % jeter, jasnim vdorom v žolčni kanal ali glavno vejo portalne vene (Vp4) pri slikanju.
English: The M3 metabolite was the predominant analyte in excreta (~17% of the dose), followed by M2' (~11% of the dose) and M2 (~4.4 of the dose).
Slovenian: Kot analit v izločkih je prevladoval presnovek M3 (~17 % odmerka), presnovkov M2' (~11 % odmerka) in M2 (~4,4 % odmerka) je bilo manj.
English: However, testicular (hypocellularity of the seminiferous epithelium) and ovarian changes (follicular atresia) were observed in repeated-dose toxicity studies in animals at exposures 11 to 15 times (rat) or 0.6 to 7 times (monkey) the anticipated clinical exposure (based on AUC) at the maximum tolerated human dose.
Slovenian: Vendar so opazili testikularne (hipocelularnost seminifernega epitelija) in ovarijske (folikularna atrezija) spremembe v študijah toksičnosti ponavljajočih se odmerkov pri živalih pri izpostavljenostih, ki so bile 11-krat do 15-krat večje (podgana) ali 0,6-krat do 7-krat večje (opica) od predvidene klinične izpostavljenosti (na podlagi AUC) pri največjem toleriranem odmerku za ljudi.
English: In case of suspected overdose, lenvatinib should be withheld and appropriate supportive care given as required.
Slovenian: V primeru suma na prevelik odmerek moramo prenehati dajati lenvatinib in po potrebi zagotoviti ustrezno podporno nego.
English: • changes in blood test results for magnesium (low), cholesterol (high) and thyroid stimulating hormone (high)
Slovenian: • spremembe rezultatov krvnih preiskav glede magnezija v krvi (znižana), holesterola (zvišan) in tirotropnega hormona (zvišan),
English: Mortality was the dose-limiting toxicity in juvenile rats in which dosing was initiated on postnatal day (PND) 7 or PND21 and was observed at exposures that were respectively 125- or 12-fold lower compared with the exposure at which mortality was observed in adult rats, suggesting an increasing sensitivity to toxicity with decreasing age.
Slovenian: Smrtnost je bila toksičnost, ki je omejevala odmerke pri mladih podganah, pri katerih se je odmerjanje začelo na postnatalni dan (PND) 7 ali PND21 in so jo opazovali pri izpostavljenostih, ki so bile 125-krat oziroma 12-krat manjše od izpostavljenosti, pri kateri so ugotavljali smrtnost pri odraslih podganah, kar kaže, da občutljivost za toksičnost raste s padanjem starosti.
English: • 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.
Slovenian: • občutek odrevenelosti ali šibkosti na eni strani telesa, močan glavobol, napad krčev, zmedenost, otežen govor, spremembe vida ali občutek omotice - to so lahko znaki možganske kapi, krvavitve v možganih ali učinki močnega zvišanja krvnega tlaka na vaše možgane;
English: Median OS was longer by approximately 2.5 months in the lenvatinib compared with the sorafenib arm in both subsets of subjects (with or without post-treatment anticancer therapy).
Slovenian: Mediano OS je bila za približno 2,5 meseca daljše v kraku z lenvatinibom v primerjavi s krakom s sorafenibom v obeh podskupinah oseb (z onkološkim zdravljenjem po zdravljenju ali brez njega).
English: Randomisation was stratified by geographic region (Europe, North America, and Other), prior VEGF/VEGFR-targeted therapy (patients may have received 0 or 1 prior VEGF/VEGFR-targeted therapy), and age (≤65 years or >65 years).
Slovenian: Randomizacija je bila stratificirana po zemljepisnih regijah (Evropa, Severna Amerika, drugo), predhodnem zdravljenju, usmerjenem v VEGF/VEGFR (bolniki so lahko prejeli 0 ali 1 predhodno zdravljenje, usmerjeno v VEGF/VEGFR), in starosti (≤ 65 let ali > 65 let).
English: Women of childbearing potential must use highly effective contraception while taking lenvatinib and for one month after stopping treatment (see section 4.6).
Slovenian: Ženske v rodni dobi morajo med jemanjem lenvatiniba in še en mesec po končanem zdravljenju uporabljati zelo učinkovito kontracepcijo (glejte poglavje 4.6).
English: In human liver microsomes, the demethylated form of lenvatinib (M2) was identified as the main metabolite.
Slovenian: V mikrosomih človeških jeter so ugotovili, da je poglavitni presnovek demetilirana oblika lenvatiniba (M2).
English: • An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Slovenian: • razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
English: Increased blood thyroid stimulating hormone (see section 4.4 Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction)
Slovenian: Zvišan tirotropni hormon v krvi (glejte poglavje 4.4 Okvara supresije tirotropnega hormona / disfunkcija ščitnice)