natgillin/translations-raw huggingface dataset:
Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking CABOMETYX. 
Bolnikom je treba naročiti, naj vsaj 2 uri pred uporabo zdravila CABOMETYX in 1 uro po tem ničesar ne jedo.
Therapy with CABOMETYX should be initiated by a physician experienced in the administration of anticancer medicinal products. 
Zdravljenje z zdravilom CABOMETYX mora uvesti zdravnik z izkušnjami v uporabi zdravil za zdravljenje raka.
The usual dose is 60 mg, however your doctor will decide on the right dose for you. 
Zdravilo CABOMETYX jemljite enkrat na dan. Običajni odmerek je 60 mg, vendar bo vaš zdravnik določil odmerek, ki je za vas pravi.
In a renal impairment study conducted with a single 60 mg dose of cabozantinib, the ratios of geometric LS mean for plasma cabozantinib, Cmax and AUC0-inf were 19% and 30% higher, for subjects with mild renal impairment (90% CI for Cmax 91.60% to 155.51%; AUC0-inf 98.79% to 171.26%) and 2% and 6-7% higher (90% CI for Cmax 78.64% to 133.52%; AUC0-inf 79.61% to 140.11%), for subjects with moderate renal impairment compared to subjects with normal renal function. 
V študiji pri osebah z okvaro ledvic, izvedeni z enkratnim 60-mg odmerkom kabozantiniba, so razmerja geometričnega povprečja LS za kabozantinib v plazmi, Cmax in AUC0-inf za 19 % oz. 30 % višja za osebe z blago okvaro ledvic (90-% IZ za Cmax 91,60 % do 155,51 %; AUC0-inf 98,79 % do 171,26 %) ter za 2 % oz. 6 do 7 % višja (90-% IZ za Cmax 78,64 % do 133,52 %; AUC0-inf 79,61 % do 140,11 %) za osebe z zmerno okvaro ledvic v primerjavi z osebami z normalnim delovanjem ledvic.
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). 
Če mora bolnik preiti z zdravljenja s kapsulami kabozantiniba na tablete kabozantiniba, mora nadaljevati z odmerkom zdravila CABOMETYX do 60 mg ali s trenutnim odmerkom zdravila COMETRIQ (kar je nižje).
The incidence of systemic non-radiation and local liver-directed systemic non-protocol anticancer therapy (NPACT) was 26% in the cabozantinib arm and 33% in the placebo arm. 
Pojavnost sistemskega ne-radiacijskega zdravljenja in lokalno v jetra usmerjenega sistemskega protitumorskega zdravljena, ki ni bil predviden po protokolu (NPACT; non-protocol anticancer therapy) je v skupini s kabozantinibom znašala 26 %, v skupini s placebom pa 33 %.
Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation. 
Po uporabi kažejo profili plazemske koncentracije kabozantiniba glede na čas drugi vrh absorpcije približno 24 ur po dajanju, kar kaže, da je lahko kabozantinib predmet enterohepatične recirkulacije.
Aetiology for HCC included 38% hepatitis B virus (HBV), 21% hepatitis C virus (HCV), 40% other (neither HBV nor HCV). 
Etiologija HCK: pri 38 % bolnikov virus hepatitisa B (HBV), pri 21 % bolnikov virus hepatitisa C (HCV) in pri 40 % bolnikov drugi vzroki (niti HBV niti HCV).
It is recommended to monitor biochemical parameters during cabozantinib treatment and to institute appropriate replacement therapy according to standard clinical practice if required. 
Med zdravljenjem s kabozantinibom je priporočljivo spremljati biokemijske parametre in po potrebi uvesti ustrezno nadomestno zdravljenje v skladu s standardno klinično prakso.
Persistent or recurring diarrhoea while on treatment may be a risk factor for the development of anal fistula. 
Trajna ali ponavljajoča se driska med zdravljenjem je lahko dejavnik tveganja za nastanek analne fistule.
If adverse reaction does not resolve, permanently discontinue CABOMETYX. 
Če neželeni učinki ne izzvenijo, trajno prenehajte z uporabo zdravila CABOMETYX.
Subjects with untreated, or incompletely treated, varices with bleeding or high risk for bleeding were also excluded from this study. 
Iz študije so izključili tudi osebe z nezdravljenimi ali nepopolno zdravljenimi varicami, ki so krvavele, ali pa je obstajalo visoko tveganje, da zakrvavijo.
• Decrease in levels of; calcium, sodium and phosphate in the blood 
• znižanje ravni kalcija, natrija in fosfatov v krvi
Comparable results for OS were observed with a follow-up analysis (descriptive) at 430 events. 
Pri nadaljnji analizi (opisni) so bili rezultati za OS pri 430 dogodkih primerljivi.
The baseline demographic and disease characteristics were similar between the CABOMETYX and placebo arms and are shown below for all 707 randomised patients: 
Izhodiščne demografske značilnosti in lastnosti bolezni so bile med skupino z zdravilom CABOMETYX in skupino s placebom podobne in so v nadaljevanju prikazane za vseh 707 randomiziranih bolnikov:
HR (95% CI); stratified b,c 
HR (95-% IZ); stratificiranib,c
Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, drug resistance, and metastatic progression of cancer. 
Kabozantinib je majhna molekula, ki zavira več receptorskih tirozin-kinaz (RTK), vpletenih v rast tumorja in angiogenezo, patološko preoblikovanje kosti, odpornost na zdravilo in metastatsko napredovanje raka.
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. 
Zdravilo CABOMETYX zavre delovanje beljakovin, imenovanih receptorji tirozin kinaze (RTK), ki sodelujejo pri rasti celic in razvoju novih krvnih žil, ki jih oskrbujejo.
Tumour assessments were conducted every 8 weeks. 
Vrednotenje tumorja je bilo izvedeno vsakih 8 tednov.
Each film-coated tablet contains 31.07 mg lactose. 
Ena filmsko obložena tableta vsebuje 31,07 mg laktoze.
You may need treatment for them, or your doctor may decide to change your dose of CABOMETYX, or stop treatment altogether. 
Morda vas bo treba zdraviti ali pa se bo zdravnik odločil, da odmerek zdravila CABOMETYX spremeni ali zdravljenje ukine.
Other medicines and CABOMETYX 
Druga zdravila in zdravilo CABOMETYX
Mean clearance (CL/F) at steady-state was estimated to be 2.48 L/hr . 
Povprečni očistek (CL/F) v stanju dinamičnega ravnovesja je bil ocenjen na 2,48 l/uro.
The majority of the patients were male (78%) with a median age of 62 years. 
Večina bolnikov je bila moškega spola (78 %) z mediano starosti 62 let.
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). 
Po kriterijih Centra za zdravljenje raka Memorial Sloan (Memorial Sloan Kettering Cancer Center) za prognostično kategorijo obetov je bilo 46 % z ugodnim (0 dejavnikov tveganja), 42 % s srednje ugodnim (1 dejavnik tveganja) in 13 % s slabim obetom (2 ali 3 dejavniki tveganja).
All events were Grade 3 or 4. 
Vsi dogodki so bili 3. ali 4. stopnje.
Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib. 
Z uporabo kabozantiniba je treba prenehati, če je hipertenzija resna ali trdovratna kljub zdravljenju z antihipertenzivi in zmanjšanju odmerka kabozantiniba.
Secondary efficacy endpoints were objective response rate (ORR) and overall survival (OS). 
Sekundarna opazovana dogodka učinkovitosti sta bila stopnja objektivnega odziva (ORR) in celokupno preživetje (OS).
This could mean that your doctor needs to change the dose(s) that you take. 
To pomeni, da bo morda zdravnik moral prilagoditi odmerek/odmerke, ki ga/jih jemljete.
• Low level of albumin in blood 
• nizka raven albumina v krvi
Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible. 
Zaradi visoke stopnje vezave kabozantiniba na plazemske beljakovine (glejte poglavje 5.2) je možna interakcija z varfarinom v obliki izpodrivanja s plazemskih beljakovin.
• Alopecia (hair loss and thinning), hair colour change 
• alopecija (izpadanje ali redčenje las in dlak), sprememba barve las oziroma dlak
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. 
Dva nekonjugirana presnovka (XL184-N-oksid in produkt cepitve XL184 amida), ki imata < 1 % ciljne zaviralne učinkovitosti kinaze izhodiščnega kabozantiniba, vsak predstavljata < 10 % skupne z zdravilom povezane izpostavljenosti v plazmi.
Effect of cabozantinib on other medicinal products The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated. 
Učinka kabozantiniba na farmakokinetiko kontraceptivnih steroidov niso preučili.
During treatment with cabozantinib, all patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy. 
Med zdravljenjem s kabozantinibom je treba vse bolnike spremljati za pojav hipertenzije in jih po potrebi zdraviti s standardnimi antihipertenzivi.
Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCE 
Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCIJA
A planned interim analysis of OS was conducted at the time of the PFS analysis and did not reach the interim boundary for statistical significance (202 events, HR=0.68 [0.51, 0.90], p=0.006). 
Načrtovana vmesna analiza OS je bila opravljena v času analize PFS in ni dosegla vmesne meje za statistično značilnost (202 dogodka, HR = 0,68 [0,51; 0,90], p = 0,006).
It is used to treat: - advanced stages of a type of kidney cancer called renal cell carcinoma - liver cancer in adults who have been previously treated with a specific anticancer medicine (sorafenib). 
Uporablja se za zdravljenje: - napredovalih stopenj raka ledvic, imenovanega karcinom ledvičnih celic, - raka jeter pri odraslih, ki so se predhodno že zdravili s specifičnim zdravilom za zdravljenje raka (sorafenib).
The majority of the patients were male (75%), with a median age of 62 years. 
Večina bolnikov je bila moških (75 %) z mediano starosti 62 let.
Film-coating Hypromellose 2910 Titanium dioxide (E171) Triacetin 
Filmska obloga hipromeloza 2910 titanov dioksid (E171) triacetin rumeni železov oksid (E172)
Also, some medicines can affect the way CABOMETYX works. 
Prav tako lahko nekatera druga zdravila vplivajo na delovanje zdravila CABOMETYX.
Each film-coated tablet contains 15.54 mg lactose. 
Ena filmsko obložena tableta vsebuje 15,54 mg laktoze.
Do not use this medicine after the expiry date which is stated on the blister, bottle label and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu, na nalepki plastenke in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Patients with both positive and negative MET status showed a favourable effect with CABOMETYX compared to sunitinib, with greater activity in patients with a positive MET status compared to patients with a negative MET status (HR=0.32 (0.16, 0.63) vs 0.67 (0.37, 1.23)) respectively. 
Pri bolnikih z obema, pozitivnim in negativnim statusom MET, so ugotovili koristen učinek zdravila CABOMETYX v primerjavi s sunitinibom, z večjo aktivnostjo pri bolnikih s pozitivnim statusom MET v primerjavi z bolniki z negativnim statusom MET (HR = 0,32 (0,16; 0,63) v primerjavi z 0,67 (0,37; 1,23)).
Secondary efficacy endpoints were progression-free survival (PFS) and objective response rate (ORR), as assessed by the Investigator using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. 
Sekundarna opazovana dogodka učinkovitosti sta bila preživetje brez napredovanja bolezni (PFS; progression-free survival) in delež objektivnega odziva (ORR; objective response rate), ki ga je ocenil raziskovalec na osnovi različice 1.1 kriterijev za vrednotenje odziva pri solidnih tumorjih (RECIST; Response Evaluation Criteria in Solid Tumours).
- - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila CABOMETYX - če ste alergični na kabozantinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Re-initiate at a reduced dose. 
Ponovno uvedite zdravljenje z zmanjšanim odmerkom.
Aneurysms and artery dissections 
Anevrizme in disekcije arterije
Each bottle contains 30 film-coated tablets. 
Vsaka plastenka vsebuje 30 filmsko obloženih tablet.
• Feeling drowsy, confused or loss of consciousness. 
• občutek zaspanosti, zmedenost ali izguba zavesti.
Exploratory analyses of PFS and OS in the ITT population have also shown consistent results in favour of CABOMETYX compared to everolimus across different subgroups according to age (<65 vs. ≥65, sex, MSKCC risk group (favourable, intermediate, poor), ECOG status (0 vs. 1), time from diagnosis to randomisation (<1 year vs. ≥1 year), tumour MET status (high vs. low vs. unknown), bone metastases (absence vs. presence), visceral metastases (absence vs. presence), visceral and bone metastases (absence vs. presence), number of prior VEGFR-TKIs (1 vs. ≥2), duration of first VEGFRTKI (≤6 months vs. >6 months). 
Raziskovalne analize PFS in OS v populaciji ITT so pokazale tudi skladne rezultate v korist zdravila CABOMETYX v primerjavi z everolimusom za različne podskupine glede na starost (< 65 v primerjavi z ≥ 65, spol, skupino tveganja MSKCC (ugoden, srednje ugoden, slab), status ECOG (0 v primerjavi z 1), čas od diagnoze do randomizacije (< 1 leto v primerjavi z ≥ 1 leto), status MET za tumor (visok v primerjavi z nizkim v primerjavi z neznanim), metastaze v kosteh (odsotnost v primerjavi s prisotnostjo), visceralne metastaze (odsotnost v primerjavi s prisotnostjo), visceralne in kostne metastaze (odsotnost v primerjavi s prisotnostjo), število predhodnih VEGFR-TKI (1 v primerjavi z ≥ 2), trajanje prvega VEGFR-TKI (≤ 6 mesecev v primerjavi z > 6 mesecev).
Events were Grade 2 or 3. 
Dogodki so bili 2. ali 3. stopnje.
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. 
V farmakokinetični analizi populacije kabozantiniba s podatki, zbranimi pri 1.883 bolnikih in 140 zdravih prostovoljcih, je končni razpolovni čas kabozantiniba v plazmi po peroralni uporabi odmerkov v razponu od 20 do 140 mg znašal približno 110 ur.
Diarrhoea led to dose modifications, interruptions and discontinuations in 84/467 (18%), 69/467 (15%) and 5/467 (1%) of subjects, respectively. 
Zaradi driske je bilo treba odmerek prilagoditi pri 84/467 (18 %) bolnikov, odmerjanje prekiniti pri 69/467 (15 %) bolnikov in zdravljenje ukiniti pri 5/467 (1 %) bolnikov.
Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities. 
Prekinitev odmerka se priporoča pri obravnavi toksičnosti 3. ali višje stopnje toksičnosti po CTCAE (common terminology criteria for adverse events) ali nevzdržni toksičnosti 2. stopnje.
Progressive Disease a in accord with EU censoring b Stratification factors per IxRS comprise IMDC risk categories (intermediate risk, poor risk and bone metastasis (yes, no) c Estimated using the Cox proportional hazard model adjusted for stratification factors per IxRS. 
Napredujoča bolezen a v skladu z EU krnjenjem b Faktorji stratifikacije po IxRS obsegajo kategorije tveganja po IMDC (srednje ugoden, slab prognostičen obet) in zasevke v kosteh (da, ne) c Ocenjeno s pomočjo Coxovega modela proporcionalne ogroženosti, prilagojeno glede na dejavnike stratifikacije po IxRS.
You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking CABOMETYX and for at least 4 months after treatment has finished. 
Zato morate med jemanjem zdravila CABOMETYX in še vsaj 4 mesece po koncu zdravljenja uporabljati tudi pregradno kontracepcijsko metodo (npr. kondom ali diafragmo).
• Feeling drowsy, confused or loss of consciousness due to liver problems 
• občutek zaspanosti, zmedenost ali izguba zavesti zaradi težav z jetri
ECOG performance status (PS) 0: 53% or ECOG PS 1: 47%. 
Stanje telesne zmogljivosti po lestvici ECOG 0: 53 % ali 1: 47 %.
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). 
Randomizacija je bila stratificirana glede na etiologijo bolezni (HBV [s HCV ali brez], HCV [brez HBV] ali drugo), geografsko regijo (Azija, druge regije) in prisotnost ekstrahepatične razširitve bolezni in/ali invazije v večje krvne žile (Da, Ne).
Concomitant medicinal products that are strong inhibitors of CYP3A4 should be used with caution, and chronic use of concomitant medicinal products that are strong inducers of CYP3A4 should be avoided (see sections 4.4 and 4.5). 
Pri sočasni uporabi z drugimi zdravili, ki so močni zaviralci CYP3A4, je potrebna previdnost, kronično uporabo z zdravili, ki so močni induktorji CYP3A4, pa je treba preprečiti (glejte poglavji 4.4 in 4.5).
Close monitoring of overall safety is recommended in these patients (see sections 4.4 
Pri teh bolnikih je priporočljivo skrbno spremljanje celokupne varnosti (glejte poglavji 4.4 in 5.2).
Table 1: Recommended CABOMETYX dose modifications for adverse reactions Adverse reaction and severity 
Preglednica 1: Priporočena prilagoditev odmerka zdravila CABOMETYX pri neželenih učinkih Neželeni učinki in resnost
Figure 4: Kaplan-Meier curve of overall survival (CELESTIAL) 
Slika 4: Kaplan-Meierjeva krivulja celokupnega preživetja (CELESTIAL)
You should not take CABOMETYX with food. 
Zdravila CABOMETYX ne smete jemati s hrano.
Hazard ratio < 1 indicates progression-free survival in favor of cabozantinib 
Razmerje ogroženosti < 1 kaže preživetje brez napredovanja bolezni v korist kabozantiniba
What you need to know before you take CABOMETYX 3. 
Kaj morate vedeti, preden boste vzeli zdravilo CABOMETYX
Grade 1 and Grade 2 adverse reactions which are tolerable and easily managed 
Neželeni učinki 1. stopnje in 2. stopnje, ki jih bolnik prenaša in jih je možno enostavno obravnavati
In rat and dog repeat-dose toxicity studies up to 6 months duration, target organs for toxicity were GI tract, bone marrow, lymphoid tissues, kidney, adrenal and reproductive tract tissues. 
V študijah toksičnosti pri ponavljajočih se odmerkih pri podganah in psih, ki so trajale do 6 mesecev, so bili ciljni organi za toksičnost prebavila, kostni mozeg, limfoidno tkivo, ledvice, tkivo nadledvične žleze in rodila.
CABOMETYX contains lactose (a type of sugar). 
Zdravilo CABOMETYX vsebuje laktozo (vrsta sladkorja).
Patients could have received one other prior systemic therapy for advanced disease in addition to sorafenib. 
Bolniki so poleg sorafeniba predhodno lahko prejeli tudi katero drugo predhodno sistemsko zdravljenje zaradi napredovale bolezni.
For patients with worsening of liver function tests considered related to cabozantinib treatment (i.e. where no alternative cause is evident), the dose modification advice in Table 1 should be followed (see section 
Pri bolnikih, pri katerih se presodi, da je prišlo do poslabšanja rezultatov preiskav delovanja jeter zaradi zdravljenja s kabozantinibom (npr. če ni drugega očitnega vzroka), je treba upoštevati nasvet za prilagoditev odmerka v preglednici 1 (glejte poglavje 4.2).
A 19% increase in the Cmax of the tablet formulation (CABOMETYX) compared to the capsule formulation (COMETRIQ) was observed. 
Opazili so 19-% povečanje Cmax pri obliki s tabletami (zdravilo CABOMETYX) v primerjavi s kapsulami (zdravilo COMETRIQ).
CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. 
Zdravilo CABOMETYX je v monoterapiji indicirano za zdravljenje hepatocelularnega karcinoma (HCK) pri odraslih bolnikih, ki so se predhodno že zdravili s sorafenibom.
Four metabolites were present in plasma at exposures (AUC) greater than 10% of parent: XL184-N-oxide, XL184 amide cleavage product, XL184 monohydroxy sulfate, and 6-desmethyl amide cleavage product sulfate. 
V plazmi so bili prisotni štirje presnovki po izpostavitvah (AUC), večjih od 10 % izhodiščne spojine: XL184-N-oksid, produkt cepitve XL184 amida, XL184 monohidroksi sulfat in produkt cepitve 6-desmetil amid sulfata.
Only limited QoL data are available after this period. 
Po tem obdobju je na voljo le malo podatkov o kakovosti življenja.
• A burning or stinging sensation of the tongue 
• pekoč ali zbadajoč občutek v jeziku
NOAEL for embryofoetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose. 
NOAEL za toksičnost embria-zarodka in izsledki o teratogenosti so bili pod ravnmi klinične izpostavljenosti pri ljudeh pri nameravanih terapevtskih odmerkih.
Primary PFS analysis Population Intent-To-Treat Population 
Populacija za primarno analizo PFS
If you get side effects, your doctor may tell you to take CABOMETYX at a lower dose. 
Če opazite neželene učinke, vam bo zdravnik morda naročil, da jemljite manjše odmerke zdravila CABOMETYX.
Hepatocellular Carcinoma (HCC) 
Hepatocelularni karcinom (HCK)
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). 
Nobena oseba, ki je bila zdravljena s kabozantinibom v tej študiji, ni imela potrjenega QTcF > 500 ms, niti ga ni imela nobena oseba, zdravljena s kabozantinibom v študijah, izvedenih pri bolnikih s KLC ali bolnikih s HCK (pri odmerku 60 mg).
Clinical data in Hepatocellular Carcinoma 
Klinični podatki pri hepatocelularnem karcinomu
Consider re-initiating at a reduced dose. 
Razmislite o ponovni uvedbi zdravljenja z zmanjšanim odmerkom.
• Abscess (collection of pus, with swelling and inflammation) 
• absces (nabiranje gnoja z oteklostjo in vnetjem)
Patients (N=157) with previously untreated, locally advanced or metastatic RCC with a clear cell component were randomized (1:1) to receive CABOMETYX (N=79) or sunitinib (N=78). 
Bolniki (N = 157) s predhodno nezdravljenim, lokalno napredovalim ali metastatskim KLC s komponento svetle celice so bili randomizirani (1:1) za prejemanje zdravila CABOMETYX (N = 79) ali sunitiniba (N = 78).
These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS). 
To so lahko znaki bolezni, ki se imenuje sindrom posteriorne reverzibilne levkoencefalopatije (RPLS, reversible posterior leukoencephalopathy syndrome).
The European Medicines Agency has waived the obligation to submit the results of studies with CABOMETYX in all subsets of the paediatric population in treatment of hepatocellular carcinoma, and kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom CABOMETYX za vse podskupine pediatrične populacije za zdravljenje hepatocelularnega karcinoma in karcinoma ledvic ali karcinoma ledvične ponvice (razen za nefroblastom, nefroblastomatozo, sarkom svetlih celic, mezoblastni nefrom, renalni medularni karcinom in rabdoidni tumor ledvic) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Table 2: Adverse drug reactions (ADRs) reported in clinical trials in patients treated with cabozantinib 
Preglednica 2: Neželeni učinki zdravila, o katerih so poročali v kliničnih preskušanjih pri bolnikih, ki so se zdravili s kabozantinibom
In patients with mild hepatic impairment no dose adjustment is required. 
Pri bolnikih z blago okvaro jeter odmerka ni treba prilagajati.
• Low level of a type of white blood cell (lymphocytes) 
• nizko število vrste belih krvnih celic (limfociti)