FrancophonIA/ELRC3.0 huggingface dataset:
English: Presence of macroscopic vascular invasion and/ or extra-hepatic tumour spread:78%, Alfa-fetoprotein (AFP) levels ≥400 μg/L: 41%.
Slovenian: Vrednosti alfa-fetoproteina (AFP) ≥ 400 μg/l: 41 %.
English: CABOMETYX contains lactose
Slovenian: Zdravilo CABOMETYX vsebuje laktozo
English: In the HCC study (CELESTIAL), portal vein thrombosis was observed with cabozantinib, including one fatal event.
Slovenian: V študiji HCK (CELESTIAL) so pri uporabi kabozantiniba poročali o trombozi portalne vene, vključno z enim smrtnim primerom.
English: In hepatocellular carcinoma following prior systemic therapy, dose reductions and dose interruptions occurred in 62% and 84%, respectively, of cabozantinib-treated patients in the clinical trial (CELESTIAL).
Slovenian: Pri zdravljenju hepatocelularnega karcinoma po predhodnem sistemskem zdravljenju je bil odmerek zmanjšan pri 62 % bolnikov in odmerjanje prekinjeno pri 84 % bolnikov, ki so se zdravili s kabozantinibom v kliničnem preskušanju (CELESTIAL).
English: The most common serious adverse drug reactions in the HCC population (≥1% incidence) are hepatic encephalopathy, palmar-plantar erythrodysaesthesia syndrome, asthenia and diarrhoea.
Slovenian: Najpogostejši resni neželeni učinki zdravila v populaciji bolnikov s HCK (pojavnost ≥ 1 %) so bili jetrna encefalopatija, sindrom palmarno-plantarne eritrodisestezije, astenija in driska.
English: In the treatment-naïve RCC study (CABOSUN), GI perforations were reported in 2.6% (2/78) of cabozantinib-treated patients.
Slovenian: V študiji, izvedeni pri predhodno nezdravljenih bolnikih s KLC (CABOSUN), so o GI perforacijah poročali pri 2,6 % (2/78) bolnikov, ki so se zdravili s kabozantinibom.
English: The other ingredients are: - Tablet contents: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide anhydrous, magnesium stearate.
Slovenian: Druge sestavine zdravila so: - Jedro tablete: mikrokristalna celuloza, brezvodna laktoza, hidroksipropilceluloza, premreženi natrijev karmelozat, brezvodni koloidni silicijev dioksid, magnezijev stearat (glejte poglavje 2
English: • Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, abdominal pain,
Slovenian: • razdražen želodec, vključno z drisko, slabostjo, bruhanjem, zaprtjem, prebavnimi motnjami in bolečinami v trebuhu
English: Thirty-six percent (36%) of patients had bone metastases.
Slovenian: Zasevke v kosteh je imelo 36 % bolnikov.
English: Median PFS (95% CI), months HR (95% CI), p-value1
Slovenian: Mediana PFS (95-% IZ), meseci HR (95-% IZ), p-vrednost1
English: Therefore, co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Slovenian: Zato je potrebna pri sočasni uporabi močnih zaviralcev CYP3A4 (npr. ritonavirja, itrakonazola, eritromicina, klaritromicina, soka grenivke) s kabozantinibom previdnost.
English: • Increase in cholesterol levels in the blood
Slovenian: • zvišanje ravni holesterola v krvi
English: Crossover from placebo to cabozantinib was not allowed during theblinded treatment phase.
Slovenian: Med zaslepljeno fazo zdravljenja prehod iz skupine s placebom v skupino s kabozantinibom ni bil dovoljen.
English: Clinical data in treatment-naïve renal cell carcinoma
Slovenian: Klinični podatki pri predhodno nezdravljenem karcinomu ledvičnih celic
English: The most common serious adverse drug reactions in the RCC population (≥1% incidence) are diarrhoea, hypertension, dehydration, hyponatraemia, nausea, decreased appetite, embolism, fatigue, hypomagnesaemia, palmar-plantar erythrodysaesthesia syndrome (PPES).
Slovenian: Najpogostejši resni neželeni učinki zdravila v populaciji bolnikov s KLC (pojavnost ≥ 1 %) so bili driska, hipertenzija, dehidracija, hiponatriemija, navzea, zmanjšanje apetita, embolija, utrujenost, hipomagneziemija in sindrom palmarno-plantarne eritrodisestezije (PPES).
English: A statistically significant improvement in OS was demonstrated for CABOMETYX compared to placebo (Table 6 and Figure 4).
Slovenian: Za zdravilo CABOMETYX je bilo v primerjavi s placebom dokazano statistično pomembno izboljšanje celokupnega preživetja (OS) (preglednica 6 in slika 4).
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib (see section 4.5).
Slovenian: Bolnike je treba opozoriti na uporabo substratov P-gp (npr. feksofenadina, aliskirena, ambrisentana, dabigatran eteksilata, digoksina, kolhicina, maraviroka, posakonazola, ranolazina, saksagliptina, sitagliptina, talinolola, tolvaptana) sočasno s kabozantinibom (glejte poglavje 4.5).
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4)
Slovenian: Common Terminology Criteria for Adverse Events), različica 4.0.
English: There is a possibility your fertility could be affected by treatment with CABOMETYX.
Slovenian: Obstaja možnost, da bo zdravilo CABOMETYX vplivalo na vašo plodnost.
English: Hepatic effects Abnormalities of liver function tests (increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin) have been frequently observed in patients treated with cabozantinib.
Slovenian: Pri bolnikih, ki so se zdravili s kabozantinibom, so pogosto opažali nenormalne izvide preiskav delovanja jeter (zvišanje vrednosti alanin-aminotransferaze [ALT], aspartat-aminotransferaze [AST] in bilirubina).
English: Median time to onset was 4.9 weeks.
Slovenian: Mediani čas do pojava je bil 4,9 tedna.
English: Progression-free survival (PFS)3 Median PFS in months (95% CI) HR (95% CI)1 p-value1
Slovenian: Preživetje brez napredovanja bolezni (PFS)3 Mediana PFS v mesecih (95-% IZ) HR (95-% IZ)1 p-vrednost1
English: Patients with a history of portal vein invasion appeared to be at higher risk of developing portal vein thrombosis.
Slovenian: Kaže, da obstaja večje tveganje za razvoj tromboze portalne vene pri bolnikih z invazijo portalne vene v anamnezi.
English: Figure 3: Kaplan Meier curve for progression-free survival by IRC in treatment-naïve RCC subjects
Slovenian: Slika 3: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po oceni IRC pri predhodno nezdravljenih osebah s KLC
English: The baseline demographic and disease characteristics were similar between the CABOMETYX and everolimus arms.
Slovenian: Izhodiščne demografske značilnosti in značilnosti bolezni so bile v kraku z zdravilom CABOMETYX podobne tistim v kraku z everolimusom.
English: Infections and infestations abscess
Slovenian: Infekcijske in parazitske bolezni absces
English: - have high blood pressure - have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall - have diarrhoea - have a recent history of significant bleeding - have had surgery within the last month (or if surgical procedures are planned), including dental surgery - have inflammatory bowel disease (for example, Crohn's disease or ulcerative colitis,
Slovenian: - imate drisko - imate znatno krvavitev v nedavni anamnezi - ste imeli v zadnjem mesecu kirurški poseg (ali ga načrtujete), vključno z zobozdravstvenimi posegi - imate vnetno bolezen črevesja (na primer Crohnovo bolezen ali ulcerozni kolitis, divertikulitis ali apendicitis) - imate v nedavni anamnezi krvni strdek v nogi, možgansko kap ali srčni infarkt - imate bolezen jeter ali ledvic
English: • Haemorrhoids (piles)
Slovenian: • epileptični krči (konvulzije)
English: Figure 2: Kaplan-Meier curve of overall survival in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Slovenian: Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja pri osebah s KLC po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF) (METEOR)
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), fistulas were reported in 1.2% (4/331) of cabozantinib-treated patients and included anal fistulas in 0.6% (2/331) cabozantinibtreated patients.
Slovenian: V študiji, izvedeni pri bolnikih s KLC po predhodnem zdravljenju, usmerjenem v VEGF (METEOR), so o fistulah poročali pri 1,2 % (4/331) bolnikov, zdravljenih s kabozantinibom, vključno z analnimi fistulami pri 0,6 % (2/331) bolnikov, zdravljenih s kabozantinibom.
English: Closer monitoring is advised in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter je priporočljivo skrbno spremljanje.
English: Patients had to have intermediate or poor risk disease as defined by the International Metastatic RCC Database Consortium (IMDC) risk group categories.
Slovenian: CABOMETYX everolimus kategorijami skupin tveganja za KLC po IMDC (International Metastatic RCC Database Consortium).
English: How to take CABOMETYX
Slovenian: Kako jemati zdravilo CABOMETYX
English: Table 5: Efficacy results in treatment-naïve RCC subjects (ITT population, CABOSUN) CABOMETYX (N=79)
Slovenian: Preglednica 5: Rezultati učinkovitosti pri predhodno nezdravljenih osebah s KLC (ITT, Intent-To-Treat populacija, CABOSUN)
English: The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the RCC population included diarrhoea, hypertension, fatigue, AST increased, ALT increased, nausea, decreased appetite, PPES, dysgeusia, platelet count decreased, stomatitis, anaemia, vomiting, weight decreased, dyspepsia, and constipation.
Slovenian: Najpogostejši neželeni učinki katere koli stopnje (ki so se pojavili pri vsaj 25 % bolnikov) v populaciji bolnikov s KLC so bili driska, hipertenzija, utrujenost, zvišanje vrednosti AST, zvišanje vrednosti ALT, navzea, zmanjšanje apetita, sindrom palmarno-plantarne eritrodisestezije (PPES), paragevzija, zmanjšanje števila trombocitov, stomatitis, anemija, bruhanje, zmanjšanje telesne mase, dispepsija in konstipacija.
English: In treatment-naïve renal cell carcinoma, dose reductions and dose interruptions occurred in 46% and 73%, respectively, of cabozantinib-treated patients in the clinical trial (CABOSUN).
Slovenian: Pri zdravljenju predhodno nezdravljenega karcinoma ledvičnih celic je bil odmerek zmanjšan pri 46 % bolnikov in odmerjanje prekinjeno pri 73 % bolnikov, ki so se zdravili s kabozantinibom v kliničnem preskušanju (CABOSUN).
English: In the HCC study (CELESTIAL), fatal haemorrhagic events were reported at a higher incidence with cabozantinib than placebo.
Slovenian: V študiji HCK (CELESTIAL) so poročali o usodnih krvavitvah, katerih pojavnost je bila pri uporabi kabozantiniba večja kot pri uporabi placeba.
English: The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the HCC population included diarrhoea, palmar-plantar erythrodysaesthesia syndrome, fatigue, decreased appetite hypertension and nausea.
Slovenian: Najpogostejši neželeni učinki katere koli stopnje (ki so se pojavili pri vsaj 25 % bolnikov) v populaciji bolnikov s HCK so bili driska, sindrom palmarno-plantarne eritrodisestezije, utrujenost, zmanjšanje apetita, hipertenzija in navzea.
English: Figure 1: Kaplan Meier curve for progression-free survival by independent radiology review committee, in RCC subjects following prior vascular endothelial growth factor (VEGF)targeted therapy (first 375 subjects randomized) (METEOR)
Slovenian: Slika 1: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po oceni neodvisne radiološke komisije pri osebah s KLC po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF) (prvih 375 randomiziranih oseb) (METEOR)
English: Musculoskeletal and connective tissue disorders pain in extremity muscle spasms, arthralgia osteonecrosis of the jaw
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečine v okončinah mišični krči, artralgija osteonekroza čeljusti
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), GI perforations were reported in 0.9% (3/331) of cabozantinib-treated RCC patients.
Slovenian: V študiji, izvedeni pri bolnikih s KLC po predhodnem zdravljenju, usmerjenem v VEGF (METEOR), so o GI perforacijah poročali pri 0,9 % (3/331) bolnikov, zdravljenih s kabozantinibom.
English: Cabozantinib has been associated with an increased incidence of electrolyte abnormalities (including hypo- and hyperkalaemia, hypomagnesaemia, hypocalcaemia, hyponatremia).
Slovenian: Nenormalni izvidi biokemijskih laboratorijskih preiskav Uporaba kabozantiniba je bila povezana z večjo pojavnostjo elektrolitskih nepravilnosti (vključno s hipokaliemijo, hiperkaliemijo, hipomagneziemijo, hipokalciemijo in hiponatriemijo).
English: CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC): - in treatment-naïve adults with intermediate or poor risk (see section 5.1) - in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy
Slovenian: KLINIČNI PODATKI 4.1 Terapevtske indikacije Karcinom ledvičnih celic (KLC) Zdravilo CABOMETYX je indicirano za zdravljenje napredovalega karcinoma ledvičnih celic (KLC): - pri predhodno nezdravljenih odraslih bolnikih s srednje ugodnim ali slabim prognostičnim obetom (glejte poglavje 5.1).
English: In the HCC study (CELESTIAL), the incidence of severe haemorrhagic events (Grade ≥ 3) was 7.3% in cabozantinib-treated patients (34/467).
Slovenian: V študiji, izvedeni pri bolnikih s HCK (CELESTIAL), je pojavnost dogodkov hude krvavitve (≥ 3. stopnje) pri bolnikih, ki so se zdravili s kabozantinibom, znašala 7,3 % (34/467).
English: Serious gastrointestinal (GI) perforations and fistulas, sometimes fatal, have been observed with cabozantinib.
Slovenian: Pri uporabi kabozantiniba so opazili resne gastrointestinalne perforacije in fistule, ki so bile včasih tudi usodne.
English: • Increase in blood triglyceride levels in the blood
Slovenian: • zvišanje ravni trigliceridov v krvi
English: Table 6: Efficacy results in HCC (ITT population, CELESTIAL) CABOMETYX (N=470)
Slovenian: Preglednica 6: Rezultati učinkovitosti pri bolnikih s HCK (ITT, Intent-To-Treat populacija, CELESTIAL)
English: There is limited data in patients with moderate hepatic impairment (n=15) as per NCI-ODWG (National Cancer Institute - Organ Dysfunction working Group) criteria.
Slovenian: Pri bolnikih z zmerno okvaro jeter je v skladu s kriteriji NCI-ODWG (National
English: Table 4: Summary of ORR findings per independent radiology committee review (IRC) and investigator review, in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy
Slovenian: Preglednica 4: Povzetek izsledkov ORR po oceni neodvisnih radioloških komisij (IRC, independent radiology committee) in oceni raziskovalca, pri osebah s KLC po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF)
English: • Blisters, pain of the hands or soles of the feet, rash or redness of the skin
Slovenian: • mehurji, bolečine v dlaneh ali podplatih, izpuščaj ali rdečina kože
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), diarrhoea was reported in 74% of cabozantinib-treated RCC patients (245/331); Grade 3-4 events in 11%.
Slovenian: V študiji, izvedeni pri bolnikih s KLC po predhodnem zdravljenju, usmerjenem v VEGF (METEOR), so o driski poročali pri 74 % bolnikov s KLC, ki so se zdravili s kabozantinibom (245/331); dogodki 3.-4. stopnje pri 11 % bolnikov.
English: A higher relative proportion of patients with moderate hepatic impairment (Child-Pugh B) developed hepatic encephalopathy with cabozantinib treatment.
Slovenian: Pri zdravljenju s kabozantinibom se je jetrna encefalopatija pojavila pri višjem relativnem deležu bolnikov z zmerno okvaro jeter (Child-Pugh B).
English: • Numbness, tingling, burning sensation or pain in the limbs
Slovenian: • odrevenelost, mravljinčenje, pekoč občutek ali bolečina v okončinah
English: Vascular disorders hypertension, haemorrhage venous thrombosis arterial thrombosis
Slovenian: Žilne bolezni hipertenzija, krvavitev venska tromboza, arterijska tromboza anevrizme in disekcije arterij
English: Based on the populationpharmacokinetic (PK) model, the volume of distribution of the central compartment (Vc/F) was estimated to be 212 L. Protein binding was not altered in subjects with mild or moderately impaired renal or hepatic function.
Slovenian: Na podlagi farmakokinetičnega modela populacije je bil volumen porazdelitve v centralnem prostoru (Vc/F) ocenjen na 212 litrov.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta
English: CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets cabozantinib
Slovenian: CABOMETYX 20 mg filmsko obložene tablete CABOMETYX 40 mg filmsko obložene tablete CABOMETYX 60 mg filmsko obložene tablete kabozantinib
English: General disorders and administration site conditions fatigue, mucosal inflammation, asthenia, peripheral oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost, vnetje sluznice, astenija, periferni edem
English: • Decrease in bile flow from the liver
Slovenian: • zmanjšanje pretoka žolča iz jeter
English: Cabozantinib treatment should be discontinued in patients with RPLS.
Slovenian: Pri bolnikih z RPLS je treba zdravljenje s kabozantinibom prekiniti.
English: Hepatic encephalopathy
Slovenian: Jetrna encefalopatija
English: CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets
Slovenian: CABOMETYX 20 mg filmsko obložene tablete CABOMETYX 40 mg filmsko obložene tablete CABOMETYX 60 mg filmsko obložene tablete
English: No dose adjustment is indicated when gastric pH modifying agents (i.e., PPIs, H2 receptor antagonists, and antacids) are co-administered with cabozantinib.
Slovenian: Pri sočasni uporabi zdravil, ki spreminjajo vrednost pH v želodcu (tj. zaviralci protonske črpalke, antagonisti receptorjev H2 in antacidi), odmerka kabozantiniba ni treba prilagajati.
English: Each film-coated tablet contains 46.61 mg lactose For the full list of excipients, see section 6.1.
Slovenian: Ena filmsko obložena tableta vsebuje 46,61 mg laktoze.
English: Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy.
Slovenian: Med zdravljenjem in še vsaj 4 mesece po koncu zdravljenja morajo tako bolniki in bolnice kot tudi njihovi partnerji uporabljati zanesljiv način kontracepcije.
English: Use caution when driving or using machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med vožnjo ali uporabo strojev bodite previdni.
English: Loco-regional transarterial embolisation or chemoinfusion procedures: 44% Radiotherapy prior to cabozantinib treatment: 37% Median duration of sorafenib treatment: 5.32 months
Slovenian: Postopki loko-regionalne transarterialne embolizacije ali kemoinfuzije: 44 %.
English: In the treatment-naïve RCC study (CABOSUN), diarrhoea was reported in 73% of cabozantinibtreated patients (57/78);Grade 3-4 events in 10%..
Slovenian: V študiji, izvedeni pri predhodno nezdravljenih bolnikih s KLC (CABOSUN), so o driski poročali pri 73 % bolnikov, ki so se zdravili s kabozantinibom (57/78); dogodki 3.-4. stopnje pri 10 % bolnikov.
English: CYP3A4 inducers and inhibitors Cabozantinib is a CYP3A4 substrate.
Slovenian: Kabozantinib je substrat za CYP3A4.
English: • Increase in amylase levels in the blood
Slovenian: • zvišanje ravni amilaze v krvi
English: Table 3: Summary of PFS findings by independent radiology review committee in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Slovenian: Preglednica 3: Povzetek izsledkov PFS po oceni neodvisne radiološke komisije pri osebah s KLC po predhodnem zdravljenju, usmerjenem v vaskularni endotelijski rastni faktor (VEGF) (METEOR)
English: CABOMETYX 40 mg film-coated tablets are yellow, triangle shaped with no score, and identified with “XL” on one side and “40” on the other side.
Slovenian: Zdravilo CABOMETYX 40 mg filmsko obložene tablete so rumene, trikotne, brez razdelilne zareze, identificirane z "XL" na eni strani in "40" na drugi strani tablete.
English: The pharmacokinetics of cabozantinib was not evaluated in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s hudo okvaro jeter farmakokinetike kabozantiniba niso vrednotili.
English: How CABOMETYX works
Slovenian: Kako deluje zdravilo CABOMETYX
English: Probability of Progression-Free Survival
Slovenian: Verjetnost preživetja brez napredovanja
English: No cases of hepatic encephalopathy were reported in the RCC studies (METEOR and CABOSUN).
Slovenian: V študijah, izvedenih pri bolnikih s KLC (METEOR in CABOSUN), o primerih jetrne encefalopatije niso poročali.
English: CABOMETYX 60 mg film-coated tablets are yellow, oval shaped with no score, and identified with “XL” on one side and “60” on the other side.
Slovenian: Zdravilo CABOMETYX 60 mg filmsko obložene tablete so rumene, ovalne, brez razdelilne zareze, identificirane z "XL" na eni strani in "60" na drugi strani tablete.
English: Dose interruption or reduction, or permanent discontinuation of cabozantinib should be considered in case of persistent or recurrent significant abnormalities (see Table 1).
Slovenian: Če pomembne nepravilnosti vztrajajo ali se ponavljajo, je treba presoditi o prekinitvi odmerjanja, zmanjšanju odmerka ali trajni ukinitvi zdravljenja s kabozantinibom (glejte preglednico 1).
English: Cardiac electrophysiology An increase from baseline in corrected QT interval by Fridericia (QTcF) of 10 - 15 ms on Day 29 (but not on Day 1) following initiation of cabozantinib treatment (at a dose of 140 mg qd) was observed in a controlled clinical study in medullary thyroid cancer patients.
Slovenian: V kontroliranih kliničnih študijah pri bolnikih z medularnim rakom ščitnice so opazili zvišanje od izhodišča pri intervalu QT, popravljenem po Fridericiju (QTcF), za 10-15 ms na 29. dan (vendar ne na
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), the incidence of severe haemorrhagic events (Grade ≥ 3) was 2.1% (7/331) in cabozantinib-treated RCC patients.
Slovenian: V študiji, izvedeni pri bolnikih s KLC po predhodnem zdravljenju, usmerjenem v VEGF (METEOR), je pojavnost dogodkov hude krvavitve (≥ 3. stopnje) pri bolnikih s KLC, zdravljenih s kabozantinibom, znašala 2,1 % (7/331).
English: A high-fat meal moderately increased Cmax and AUC values (41% and 57%, respectively) relative to fasted conditions in healthy volunteers administered a single 140 mg oral cabozantinib dose.
Slovenian: Obrok z visoko vsebnostjo maščob je pri zdravih prostovoljcih, ki so dobili en peroralni odmerek 140 mg kabozantiniba, zmerno zvišal vrednosti Cmax in AUC (41 % oz. 57 %) v primerjavi s stanjem na tešče.
English: CABOMETYX 20 mg film-coated tablets
Slovenian: CABOMETYX 20 mg filmsko obložene tablete
English: The tablets are yellow round with no score, and debossed with “XL” on one side and “20” on the other side of the tablet.
Slovenian: Tablete so rumene, okrogle brez razdelilne zareze, z vtisom "XL" na eni strani in "20" na drugi strani tablete.
English: Wound complications
Slovenian: Ledvična okvara
English: HBV], or Other), geographic region (Asia, Other Regions), and presence of extrahepatic spread of disease and/or macrovascular invasion (Yes, No) as stratification factors (per IVRS data) 2 estimated using the Cox proportional-hazard model 3 as assessed by investigator per RECIST 1.1
Slovenian: 1 2-stranski stratificirani log-rank test z 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) kot faktorji stratifikacije (na osnovi podatkov IVRS)
English: Fertility
Slovenian: sunitinib
English: • Increase in lipase levels in the blood
Slovenian: • zvišanje ravni lipaze v krvi