FrancophonIA/ELRC3.0 huggingface dataset:
English: ECOG performance status (PS) 0: 53% or ECOG PS 1: 47%.
Croatian: ECOG funkcionalni status 0: 53 % ili ECOG funkcionalni status 1: 47 %.
English: • Blood clots in the veins, arteries and lungs
Croatian: • Krvni ugrušci u venama, arterijama i plućima
English: Presence of macroscopic vascular invasion and/ or extra-hepatic tumour spread:78%, Alfa-fetoprotein (AFP) levels ≥400 μg/L: 41%.
Croatian: Prisutnost makroskopske vaskularne invazije i/ili ekstrahepatalnog širenja tumora: 78 %, razine alfa-fetoproteina (AFP) ≥400 μg/l: 41 %.
English: Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with CABOMETYX.
Croatian: Recite liječniku ako Vi ili Vaša partnerica zatrudnite ili planirate zatrudnjeti za vrijeme liječenja CABOMETYXOM.
English: • Alopecia (hair loss and thinning), hair colour change
Croatian: • Alopecija (gubitak kose i smanjenje volumena kose), promjena boje kose
English: • Protein in urine (seen in tests)
Croatian: • Proteini u mokraći (pokazano testovima)
English: The median time to first dose reduction was 38 days, and to first dose interruption was 28 days.
Croatian: Medijan vremena do prvog smanjenja doze iznosio je 38 dana, a do prvog prekida doziranja 28 dana.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 September 2016
Croatian: Datum prvog odobrenja: 9. rujna 2016.
English: Seventy-two percent (72%) of patients had received one and 28% had received 2 prior systemic therapy regimens for advanced disease.
Croatian: Sedamdeset dva posto (72 %) bolesnika prethodno su primili jedan, a 28 % njih dva režima sistemske terapije radi uznapredovale bolesti.
English: There are limited data in patients with cardiac impairment.
Croatian: Postoje ograničeni podaci o bolesnicima s oštećenjem funkcije srca.
English: Because oral contraceptives might possibly not be considered as “effective methods of contraception”, they should be used together with another method, such as a barrier method (see section 4.5).
Croatian: Budući da postoji mogućnost da oralni kontraceptivi ne predstavljaju „učinkovitu metodu kontracepcije“, moraju se koristiti uz dodatnu metodu, kao što su mehanička sredstva kontracepcije (vidjeti dio 4.5).
English: Women taking CABOMETYX should not breast-feed during treatment and for at least 4 months after treatment has finished, as cabozantinib and/or its metabolites may be excreted in breast milk and be harmful to your child.
Croatian: Žene koje uzimaju CABOMETYX ne smiju dojiti za vrijeme liječenja i najmanje 4 mjeseca nakon završetka liječenja, budući da se kabozantinib i/ili njegovi metaboliti mogu izlučivati u majčino mlijeko i mogu naškoditi Vašem djetetu.
English: Each bottle contains 30 film-coated tablets.
Croatian: Svaka boca sadrži 30 filmom obloženih tableta.
English: Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities.
Croatian: Prekid uzimanja doza preporučuje se u slučaju zbrinjavanja toksičnosti stupnja 3 ili većeg po CTCAE-u ili nepodnošljivih toksičnosti stupnja 2.
English: If a patient must switch from cabozantinib capsules to cabozantinib tablets, the patient should continue at a CABOMETYX dose not to exceed 60 mg or the current COMETRIQ dose (whichever is lower).
Croatian: Ako bolesnik mora prijeći s kapsula kabozantiniba na tablete kabozantiniba, bolesnik treba nastaviti s dozom CABOMETYXA ne višom od 60 mg ili ne višom od trenutne doze COMETRIQA (koja god je manja).
English: PVC/PCTFE blister with push-through aluminum foil backing containing 7 film-coated tablets.
Croatian: PVC/PCTFE blister s pokrovom od aluminijske folije kroz koju se protisne tableta; sadrži 7 filmom obloženih tableta.
English: Patients with a history of portal vein invasion appeared to be at higher risk of developing portal vein thrombosis.
Croatian: Čini se kako su bolesnici s povijesti invazije portalne vene izloženi većem riziku od razvijanja tromboze portalne vene.
English: You may need treatment for them, or your doctor may decide to change your dose of CABOMETYX, or stop treatment altogether.
Croatian: Možda ćete trebati liječenje za ta stanja ili Vam liječnik može odlučiti smanjiti dozu CABOMETYXA ili potpuno prekinuti liječenje.
English: Fifty-four percent (54%) of patients had 3 or more organs with metastatic disease, including lung (63%), lymph nodes (62%), liver (29%), and bone (22%).
Croatian: Pedeset i četiri posto (54 %) bolesnika imalo je 3 ili više organa zahvaćenih metastatskom bolešću, uključujući pluća (63 %), limfne čvorove (62 %), jetru (29 %) i kosti (22 %).
English: A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a <20% reduction).
Croatian: Neutralizirajuće protutijelo na CYP2C9 pokazalo je minimalni učinak na stvaranje metabolita kabozantiniba (tj. smanjenje <20 %).
English: Events were Grade 4 and 5.
Croatian: Događaji su bili 4. i 5. stupnja.
English: Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCE
Croatian: Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu Francuska ili
English: CABOMETYX tablets are available in packs containing either 4 blisters with 7 tablets each (28 total), or one plastic bottle with 30 tablets.
Croatian: CABOMETYX tablete su dostupne u pakiranjima koja sadrže ili 4 blistera sa 7 tableta u svakom (ukupno 28) ili jednu plastičnu bocu s 30 tableta.
English: This is because CABOMETYX can affect the way some other medicines work.
Croatian: To je važno jer CABOMETYX može utjecati na način djelovanja nekih lijekova.
English: Patients could have received other prior therapies, including cytokines, and antibodies targeting VEGF, the programmed death 1 (PD-1) receptor, or its ligands.
Croatian: Bolesnici su prethodno mogli primati i druge terapije, uključujući citokine i protutijela na VEGF, receptor programirane smrti 1 (PD-1) ili njegove ligande.
English: CABOMETYX (cabozantinib) tablets and COMETRIQ (cabozantinib) capsules are not bioequivalent and should not be used interchangeably (see section 5.2).
Croatian: CABOMETYX (kabozantinib) tablete i COMETRIQ (kabozantinib) kapsule nisu bioekvivalentne i ne smiju se međusobno zamjenjivati (vidjeti dio 5.2).
English: HR (95% CI); stratified b,c
Croatian: HR (95% CI); stratificiran b,c
English: Subjects continued blinded study treatment after radiological disease progression whilst they experienced clinical benefit or until the need for subsequent systemic or liver directed local anticancer therapy.
Croatian: Ispitanici su nastavili sa zaslijepljenim ispitivanim liječenjem nakon radiološke progresije bolesti dok su imali kliničke koristi ili do potrebe za naknadnom sistemskom terapijom protiv karcinoma ili lokalnom terapijom protiv karcinoma usmjerenom na jetru.
English: Cabozantinib treatment should be stopped at least 28 days prior to scheduled surgery, including dental surgery, if possible.
Croatian: Ako je moguće, liječenje kabozantinibom treba prekinuti najmanje 28 dana prije zakazane operacije, uključujući dentalne operacije.
English: PFS and ORR findings are summarized in Table 6.
Croatian: Nalazi za PFS i ORR sažeto su navedeni u Tablici 6.
English: CABOMETYX contains lactose (a type of sugar).
Croatian: CABOMETYX sadrži laktozu (vrstu šećera).
English: This may be due to liver problems.
Croatian: To može biti zbog problema s jetrom.
English: If you forget to take CABOMETYX
Croatian: Ako ste zaboravili uzeti CABOMETYX
English: The median duration of treatment was 7.6 months (range 0.3 - 20.5) for patients receiving CABOMETYX and 4.4 months (range 0.21 - 18.9) for patients receiving everolimus.
Croatian: Medijan trajanja liječenja bio je 7,6 mjeseci (raspon 0,3 -20,5) za bolesnike koji su primali CABOMETYX i 4,4 mjeseca (raspon 0,21 -18,9) za bolesnike koji su primali everolimus.
English: Patients could have received one other prior systemic therapy for advanced disease in addition to sorafenib.
Croatian: Bolesnici su mogli primiti jednu drugu prethodnu sistemsku terapiju za uznapredovalu bolest uz sorafenib.
English: • Gastro-oesophageal reflux disease (bringing up stomach acid)
Croatian: • Gastroezofagealna refluksna bolest (vraćanje želučane kiseline)
English: Therapy with CABOMETYX should be initiated by a physician experienced in the administration of anticancer medicinal products.
Croatian: Liječenje CABOMETYXOM treba započeti liječnik s iskustvom u primjeni lijekova protiv raka.
English: Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible.
Croatian: Zbog visokih razina vezanja kabozantiniba na proteine plazme (dio 5.2) moguća je interakcija istiskivanja s proteina plazme pri istodobnoj primjeni s varfarinom.
English: Interrupt treatment until the adverse reaction resolves to Grade ≤1.
Croatian: Prekinite liječenje dok se nuspojave ne povuku do ≤ 1. stupnja.
English: Kaplan-Meier landmark estimates of percent of subjects event-free at 3 months % (95% CI)
Croatian: Kaplan-Meierova „landmark“ procjena postotka ispitanika bez događaja nakon tri mjeseca % (95 % CI)
English: Diarrhoea, nausea/vomiting, decreased appetite, and stomatitis/oral pain were some of the most commonly reported GI adverse reactions (see section 4.8).
Croatian: Proljev, mučnina/povraćanje, smanjen apetit i stomatitis/bol u ustima neke su od najčešće prijavljenih gastrointestinalnih nuspojava (vidjeti dio 4.8).
English: If your next dose is due in less than 12 hours, then do not take the dose that you have missed.
Croatian: Ako do Vaše sljedeće doze ima manje od 12 sati, nemojte uzeti propuštenu dozu.
English: No case of RPLS was reported in the METEOR or CABOSUN or CELESTIAL studies, but RPLS has been reported rarely in other clinical studies (in 2/4872 subjects; 0.04%).
Croatian: U ispitivanjima METEOR ili CABOSUN ili CELESTIAL nije bilo zabilježenih slučajeva RPLS-a, ali je pojava RPLS-a bila zabilježena rijetko u drugim kliničkim ispitivanjima (u 2/4872 ispitanika; 0,04 %).
English: Randomization was stratified by aetiology of disease (HBV [with or without HCV], HCV [without HBV], or other), geographic region (Asia, other regions) and by presence of extrahepatic spread of disease and/or macrovascular invasions (Yes, No).
Croatian: Randomizacija je stratificirana etiologijom bolesti (HBV [s HCV-om ili bez], HCV [bez HBV-a] ili drugo), geografskim područjem (Azija, druga područja) i prisutnošću ekstrahepatalnog širenja bolesti i/ili makrovaskularnih invazija (Da, Ne).
English: Objective response rate findings are summarized in Table 4.
Croatian: Rezultati stope objektivnog odgovora prikazani su u Tablici 4.
English: Crossover from placebo to cabozantinib was not allowed during theblinded treatment phase.
Croatian: Prijelaz s placeba na kabozantinib nije bilo dopušten tijekom zaslijepljene faze liječenja.
English: Prompt medical management, including supportive care with antiemetics, antidiarrhoeals, or antacids, should be instituted to prevent dehydration, electrolyte imbalances and weight loss.
Croatian: Potrebno je primijeniti hitno medicinsko liječenje, uključujući suportivnu skrb antiemeticima, antidijaroticima ili antacidima, kako bi se spriječili dehidriranost, neravnoteža elektrolita i gubitak tjelesne težine.
English: Juvenile rats (correlating to a <2- year paediatric population) showed similar treatment-related findings but appeared to be more sensitive to cabozantinib-related toxicity at comparable dose levels.
Croatian: Ispitivanja na mladim štakorima (koji su usporedivi s pedijatrijskom populacijom starosti <2 godine) pokazala su slične nalaze povezane s liječenjem, ali se pokazalo da su osjetljiviji na toksičnost povezanu s kabozantinibom pri usporedivim razinama doza.
English: The majority of the patients were male (75%), with a median age of 62 years.
Croatian: Većina bolesnika bili su muškarci (75 %), s medijanom dobi od 62 godine.
English: Seventy-one percent (71%) received only one prior VEGFR TKI; 41% of patients received sunitinib as their only prior VEGFR TKI.
Croatian: Sedamdeset i jedan posto (71 %) bolesnika prethodno je primilo samo jedan VEGFR TKI; 41 % bolesnika primilo je sunitinib kao jedini prethodni VEGFR TKI.
English: It is recommended to monitor biochemical parameters during cabozantinib treatment and to institute appropriate replacement therapy according to standard clinical practice if required.
Croatian: Preporučuje se praćenje biokemijskih parametara tijekom liječenja kabozantinibom te, prema potrebi, uvođenje prikladne nadomjesne terapije u skladu sa standardnom kliničkom praksom.
English: Secondary efficacy endpoints were objective response rate (ORR) and overall survival (OS).
Croatian: Sekundarne mjere djelotvornosti bile su stopa objektivnog odgovora (ORR) i ukupno preživljenje (OS).
English: Bioequivalence could not be demonstrated between the cabozantinib capsule and tablet formulations following a single 140 mg dose in healthy subjects.
Croatian: Bioekvivalencija između oblika kapsule i tablete kabozantiniba nije se mogla dokazati nakon primjene jedne doze od 140 mg u zdravih ispitanika.
English: If you get side effects, your doctor may tell you to take CABOMETYX at a lower dose.
Croatian: Ako Vam se jave nuspojave, liječnik će Vam možda reći da uzimate manju dozu CABOMETYXA.
English: CABOMETYX treatment was associated with a trend for longer survival compared to sunitinib (Table 5).
Croatian: Terapija CABOMETYXOM bila je povezana s trendom duljeg preživljenja u usporedbi sa sunitinibom (tablica 5).
English: What CABOMETYX is and what it is used for 2.
Croatian: Što je CABOMETYX i za što se koristi 2.
English: Tumour assessments were conducted every 8 weeks.
Croatian: Procjene tumora provedene su svakih osam tjedana.
English: Management of suspected adverse drug reactions may require temporary treatment interruption and/or dose reduction of CABOMETYX therapy (see Table 1).
Croatian: Zbrinjavanje suspektnih nuspojava lijeka može zahtijevati privremeno prekidanje terapije CABOMETYXOM i/ili smanjenje doze (vidjeti Tablicu 1).
English: CABOMETYX blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Croatian: CABOMETYX blokira djelovanje proteina koji se zovu receptorske tirozin kinaze (RTK), a koji su uključeni u rast stanica i razvoj novih krvnih žila koje ih opskrbljuju.
English: Tél: + 33 1 58 33 50 00 Hrvatska
Croatian: Tél: + 33 1 58 33 50 00
English: The Kaplan- Meier estimates for median duration of OS were 11.1 months in the cabozantinib arm versus 6.9 months in the placebo arm, an estimated 4.2-month difference in the medians.
Croatian: Kaplan-Meierova procjena za medijan trajanja ukupnog preživljenja bila je 11,1 mjesec u skupini koja je primala kabozantinib u usporedbi sa 6,9 mjeseci u skupini koja je primala placebo, procijenjena razlika od 4,2 mjeseca u medijanu.
English: - - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati CABOMETYX - ako ste alergični na kabozantinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS).
Croatian: To mogu biti znakovi stanja koje se naziva sindrom reverzibilne posteriorne leukoencefalopatije (RPLS).
English: Cabozantinib has minor influence on the ability to drive and use machines.
Croatian: Kabozantinib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • Severe or uncontrollable bleeding with symptoms such as: vomiting blood, black stolls, bloody urine, headache, coughing up blood.
Croatian: • Jako ili nezaustavljivo krvarenje sa simptomima kao što su: povraćanje krvi, crne stolice, krv u mokraći, glavobolja, iskašljavanje krvi
English: It is not known whether cabozantinib and/or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se kabozantinib i/ili njegovi metaboliti u majčino mlijeko.
English: The majority of the patients were male (78%) with a median age of 62 years.
Croatian: Bolesnici su većinom bili muškarci (78 %) s medijanom dobi od 62 godine.
English: If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Croatian: Ako Vi ili Vaša partnerica možete zatrudnjeti, tijekom liječenja i najmanje 4 mjeseca nakon liječenja koristite odgovarajuću kontracepciju.
English: Closer monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
Croatian: Preporučuje se pažljivo praćenje ukupne sigurnosti u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (vidjeti također dijelove 4.2 i 5.2).
English: Progression-free survival (PFS) was assessed by a blinded independent radiology review committee, and the primary analysis was conducted among the first 375 subjects randomized.
Croatian: Preživljenje bez progresije bolesti (engl. progression-free survival, PFS) bilo je procijenjeno od strane odbora za slijepu neovisnu radiološku procjenu te je primarna analiza provedena među prvih 375 randomiziranih ispitanika.
English: Cabozantinib was not carcinogenic in the rasH2 mouse model at a slightly higher exposure than the intended human therapeutic exposure.
Croatian: Kabozantinib se nije pokazao kancerogen na rasH2 mišjem modelu pri nešto višoj izloženosti nego što je predviđena terapijska izloženost u ljudi.
English: Only limited QoL data are available after this period.
Croatian: Nakon tog razdoblja dostupni su samo ograničeni podaci o kvaliteti života.
English: Hazard ratio < 1 indicates progression-free survival in favor of cabozantinib
Croatian: Omjer hazarda <1 ukazuje na preživljenje bez progresije bolesti u korist kabozantiniba
English: In a population PK analysis of cabozantinib using data collected from 1883 patients and 140 healthy volunteers following oral administration of a range of doses from 20 to 140 mg, the plasma terminal half-life of cabozantinib is approximately 110 hours.
Croatian: Prema populacijskoj PK analizi kabozantiniba iz podataka prikupljenih od 1883 bolesnika s i 140 zdrava dobrovoljca nakon peroralne primjene raspona doza od 20 mg do 140 mg, terminalni poluvijek kabozantiniba u plazmi iznosi približno 110 sati.
English: If adverse reaction resolves to Grade ≤1, re-initiate at a reduced dose.
Croatian: Ako se nuspojava povuče do ≤ 1. stupnja, ponovno započnite liječenje sa smanjenom dozom.
English: Each carton contains 4 blisters with 28 film-coated tablets.
Croatian: Svaka kutija sadrži 4 blistera s 28 filmom obloženih tableta.
English: In addition, cabozantinib inhibits other tyrosine kinases including the GAS6 receptor (AXL), RET, ROS1, TYRO3, MER, the stem cell factor receptor (KIT), TRKB, Fms-like tyrosine kinase-3 (FLT3), and TIE-2.
Croatian: Pored toga, kabozantinib inhibira druge tirozin kinaze, uključujući receptor GAS6 (AXL), RET, ROS1, TYRO3, MER, receptor za faktor rasta matičnih stanica (KIT), TRKB, Fms-sličnu tirozin kinazu 3 (FLT3) i TIE-2.
English: Cabozantinib is a substrate for CYP3A4 metabolism in vitro, as a neutralizing antibody to CYP3A4 inhibited formation of metabolite XL184 N-oxide by >80% in a NADPH-catalyzed human liver microsomal (HLM) incubation; in contrast, neutralizing antibodies to CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 and CYP2E1 had no effect on cabozantinib metabolite formation.
Croatian: Kabozantinib je supstrat za metabolizam putem CYP3A4 in vitro; budući da je neutralizirajuće protutijelo na CYP3A4 inhibiralo stvaranje metabolita XL184 N-oksida za >80 % pri inkubaciji s mikrosomima ljudske jetre (HLM) kataliziranoj NADPH-om; za razliku od toga, neutralizirajuća protutijela na CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 i CYP2E1 nisu imala učinak na stvaranje metabolita kabozantiniba.
English: The decision to resume cabozantinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Croatian: Odluku o nastavku terapije kabozantinibom nakon operacije mora se donijeti na temelju kliničke procjene o adekvatnom zacjeljivanju rane.
English: Diarrhoea led to dose modifications, interruptions and discontinuations in 84/467 (18%), 69/467 (15%) and 5/467 (1%) of subjects, respectively.
Croatian: Proljev je doveo do prilagodbe doze u 84/467 (18 %), privremenog prekida doziranja u 69/467 (15 %) i potpunog prekida doziranja u 5/467 (1 %) ispitanika.
English: The baseline demographic and disease characteristics were similar between the CABOMETYX and placebo arms and are shown below for all 707 randomised patients:
Croatian: Početne demografske značajke i značajke bolesti bile su slične između skupine koja je primala CABOMETYX i skupine koja je primala placebo te su prikazane u nastavku za svih 707 randomiziranih bolesnika:
English: • Decrease in levels of; calcium, sodium and phosphate in the blood
Croatian: • Smanjenje razina kalcija, natrija i fosfata u krvi
English: • Dry skin, severe itching of skin, acne
Croatian: • Suha koža, teški svrbež kože, akne
English: According to the Memorial Sloan Kettering Cancer Center criteria for prognostic risk category, 46% were favorable (0 risk factors), 42% were intermediate (1 risk factor), and 13% were poor (2 or 3 risk factors).
Croatian: Prema Memorial Sloan Kettering Cancer Center (MSKCC) kriterijima za prognostičke kategorije rizika, 46 % bolesnika spadalo je u kategoriju povoljnog rizika (0 rizičnih faktora), 42 % srednjeg (1 rizični faktor) i 13 % lošeg rizika (2 ili 3 rizična faktora).
English: Cabozantinib is not recommended for use in patients with severe renal impairment as safety and efficacy have not been established in this population.
Croatian: Ne preporučuje se primjena kabozantiniba u bolesnika s teškim oštećenjem funkcije bubrega jer sigurnost i djelotvornost u ovoj populaciji nisu ustanovljene.
English: Treatment Modification
Croatian: Prilagodba liječenja
English: No cabozantinib-treated subjects in this study had a confirmed QTcF >500 ms, nor did any cabozantinib-treated subjects in the RCC or HCC studies (at a dose of 60 mg).
Croatian: Nijedan od ispitanika koji su primali kabozantinib u ovom ispitivanju nije imao QTcF >500 ms, kao i niti jedan od ispitanika koji su primali kabozantinib u ispitivanjima RCC-a ili HCC-a (pri dozi od 60 mg).
English: Two non-conjugated metabolites (XL184N-oxide and XL184 amide cleavage product), which possess <1% of the on-target kinase inhibition potency of parent cabozantinib, each represent <10% of total drug-related plasma exposure.
Croatian: Svaki od dva nekonjugirana metabolita (XL184-N-oksid i XL184 produkt razgradnje amida), koja posjeduju <1 % potentnosti ishodišnog kabozantiniba za inhibiciju ciljne kinaze, predstavlja <10 % ukupne plazmatske izloženosti lijeku.
English: Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Croatian: Mora se razmotriti odabir zamjenskog lijeka koji se uzima istodobno, a koji nema ili ima minimalnu mogućnost indukcije ili inhibicije CYP3A4.
English: Based on an integrated population pharmacokinetic analysis of cabozantinib in healthy subjects and cancer patients (including HCC), no clinically significant difference in the mean cabozantinib plasma exposure was observed amongst subjects with normal liver function (n=1425) and mild hepatic impairment (n=558).
Croatian: Na osnovi integrirane populacijske farmakokinetičke analize kabozanitiba u zdravih ispitanika i bolesnika s karcinomom (uključujući HCC), nije zabilježena klinički značajna razlika prosječne izloženosti kabozantinibu u plazmi između ispitanika s normalnom funkcijom jetre (n=1425) i ispitanika s blagim oštećenjem funkcije jetre (n=558).
English: If adverse reaction does not resolve, permanently discontinue CABOMETYX.
Croatian: Ako se nuspojava ne povuče, trajno prekinite liječenje CABOMETYXOM.