FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Ispitivanje oštećenja funkcije bubrega provedeno s jednom dozom kabozanitiba od 60 mg ukazuje na to da su omjeri geometrijskih srednjih vrijednosti dobivenih metodom najmanjih kvadrata za kabozantinib u plazmi, Cmax i AUC0-inf bili 19 % i 30 % viši za ispitanike s blagim oštećenjem funkcije bubrega (90 % CI za Cmax 91,60 % do 155,51 %; AUC0-inf 98,79 % do 171,26 %) te 2 % i 6-7 % viši (90 % CI za Cmax 78,64 % do 133,52 %; AUC0-inf 79,61 % do 140,11 %) za ispitanike s umjerenim oštećenjem funkcije bubrega u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: • Wound complications
Croatian: • Komplikacije rane
English: The study was not powered for the OS analysis and the data are immature.
Croatian: Ispitivanje nije imalo snagu za analizu ukupnog preživljenja (OS), a podaci još nisu bili spremni za analizu.
English: Repeat daily dosing of cabozantinib at 140 mg for 19 days resulted in an approximately a 4- to 5-fold mean cabozantinib accumulation (based on AUC) compared to a single dose administration; steady state is achieved by approximately Day 15.
Croatian: Ponavljanje dnevne doze kabozantiniba od 140 mg tijekom 19 dana rezultiralo je otprilike četverostruko do peterostruko većom srednjom vrijednosti akumulacije kabozantiniba (temeljeno na AUC) u usporedbi s primjenom jedne doze; stanje dinamičke ravnoteže postignuto je otprilike 15-og dana.
English: All events were Grade 3 or 4.
Croatian: Svi su događaji bili 3. ili 4. stupnja.
English: Figure 4: Kaplan-Meier curve of overall survival (CELESTIAL)
Croatian: Slika 4: Kaplan-Meierova krivulja ukupnog preživljenja (CELESTIAL)
English: • Feeling drowsy, confused or loss of consciousness.
Croatian: • Omamljenost, zbunjenost ili gubitak svijesti.
English: Film-coating Hypromellose 2910 Titanium dioxide (E171) Triacetin
Croatian: Film-ovojnica hipromeloza 2910 titanijev dioksid (E171) triacetin žuti željezov oksid (E172)
English: Persistent or recurring diarrhoea while on treatment may be a risk factor for the development of anal fistula.
Croatian: Perzistirajući ili ponavljajući proljev za vrijeme liječenja može biti rizični čimbenik za razvoj analne fistule.
English: Because of the potential harm to the infant, mothers should discontinue breast-feeding during treatment with cabozantinib, and for at least 4 months after completing therapy.
Croatian: S obzirom da postoji mogućnost da naškodi dojenčetu, majke moraju prekinuti dojenje za vrijeme liječenja kabozantinibom te najmanje 4 mjeseca nakon završetka terapije.
English: During treatment with cabozantinib, all patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Croatian: Tijekom liječenja kabozantinibom sve se bolesnike mora kontrolirati zbog hipertenzije te po potrebi liječiti standardnom antihipertenzivnom terapijom.
English: You should not take CABOMETYX with food.
Croatian: Ne smijete uzimati CABOMETYX s hranom.
English: Cabozantinib is eliminated mainly via the hepatic route.
Croatian: Kabozantinib se uglavnom eliminira kroz jetru.
English: Clinical data in Hepatocellular Carcinoma
Croatian: Klinički podaci za hepatocelularni karcinom
English: What you need to know before you take CABOMETYX 3.
Croatian: Što morate znati prije nego počnete uzimati CABOMETYX
English: Each film-coated tablet contains 31.07 mg lactose.
Croatian: Jedna filmom obložena tableta sadrži 31,07 mg laktoze.
English: Objective Response Rate n (%) by IRC Complete responses
Croatian: Stopa objektivnog odgovora n (%) prema IRC-u Potpuni odgovor
English: 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).
Croatian: Planirana interim analiza OS-a provedena je u vrijeme analize PFS-a i nije dosegla granicu statističke značajnosti (202 događaja, HR=0,68 [0,51; 0,90]; p=0,006).
English: 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
Croatian: U bolesnika s pogoršanjem testova funkcije jetre za koje se smatra da je povezano s liječenjem kabozantinibom (odnosno, ako nema jasnog drugog razloga), potrebno je slijediti savjete za prilagodbu doze navedene u Tablici 1 (vidjeti dio 4.2).
English: Patients who have a history of severe bleeding prior to treatment initiation should be carefully evaluated before initiating cabozantinib therapy.
Croatian: U bolesnika koji u anamnezi imaju podatak o teškom krvarenju mora se napraviti pažljiva procjena prije početka liječenja kabozantinibom.
English: Close monitoring of overall safety is recommended in these patients (see sections 4.4
Croatian: Preporučuje se pažljivo praćenje ukupne sigurnosti u tih bolesnika (vidjeti dijelove 4.4 i 5.2).
English: In the case of persistent hypertension despite use of anti-hypertensives, the cabozantinib dose should be reduced.
Croatian: U slučaju perzistirajuće hipertenzije prisutne unatoč primjeni antihipertenziva, doza kabozantiniba mora se smanjiti.
English: 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).
Croatian: Primjenjuje se za liječenje: - uznapredovalih stadija vrste raka bubrega koji se naziva karcinom bubrežnih stanica - raka jetre u odraslih koji je prethodno liječen specifičnim lijekom protiv raka (sorafenibom).
English: Each film-coated tablet contains 15.54 mg lactose.
Croatian: Jedna filmom obložena tableta sadrži 15,54 mg laktoze.
English: Patients with treated brain metastases were allowed.
Croatian: Bilo je dopušteno uključenje bolesnika s liječenim metastazama na mozgu.
English: 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.
Croatian: Četiri metabolita su bila prisutna u plazmi pri izloženosti (AUC) većoj od 10 % u odnosu na ishodišnu tvar, a to su: XL184-N-oksid, XL184 produkt razgradnje amida, XL184 monohidroksi sulfat i 6-dezmetilsulfat produkta razgradnje amida.
English: • Fits, headaches, confusion, or finding it difficult to concentrate.
Croatian: • Napadaji, glavobolje, konfuzija ili otežana koncentracija.
English: • Swelling, pain in your hands and feet, or shortness of breath.
Croatian: • Oticanje, bol u rukama i stopalima ili nedostatak zraka.
English: Table 6: Efficacy results in HCC (ITT population, CELESTIAL) CABOMETYX (N=470)
Croatian: Tablica 6: Rezultati djelotvornosti za HCC (populacija bolesnika s namjerom liječenja, CELESTIAL) CABOMETYX (N=470)
English: Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
Croatian: Primjena kabozantiniba mora se prekinuti u bolesnika u kojih se jave komplikacije s cijeljenjem rana koje zahtijevaju medicinsku intervenciju.
English: 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).
Croatian: Eksplorativne analize PFS-a i OS-a u populaciji s namjerom liječenja (engl. intention- to-treat, ITT) također su pokazale dosljedne rezultate u prilog CABOMETYXA u usporedbi s everolimusom u različitim podskupinama prema dobi (<65 naspram ≥65), spolu, MSKCC skupinama rizika (povoljnog, srednjeg, lošeg rizika), ECOG statusu (0 naspram 1), vremenu od dijagnoze do randomizacije (<1 godine naspram ≥1 godine), MET statusu tumora (visok naspram nizak naspram nepoznat), koštanim metastazama (odsutnost naspram prisutnost), visceralnim metastazama (odsutnost naspram prisutnost), visceralnim i koštanim metastazama (odsutnost naspram prisutnost), broju prethodnih VEGFR-TKI-a (1 naspram ≥2), trajanju primjene prvog VEGFR-TKI (≤6 mjeseci naspram >6 mjeseci).
English: Events were Grade 2 or 3.
Croatian: Događaji su bili 2. ili 3. stupnja.
English: HDPE bottle with a polypropylene child-resistant closure and three silica gel dessicant canisters.
Croatian: HDPE boca s polipropilenskim sigurnosnim zatvaračem za djecu i tri spremnika sa sredstvom za sušenje (silika-gel).
English: Cabometyx is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) as cabozantinib has not been studied in this population and exposure might be increased in these patients.
Croatian: Upotreba Cabometyxa ne preporučuje se u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C) budući da kabozantinib nije ispitan u toj populaciji te izloženost može biti povećana u tih bolesnika.
English: For intermediate risk disease, one or two of the following risk factors were met, while for poor risk, three or more factors were met: time from diagnosis of RCC to systemic treatment < 1 year, Hgb < LLN, Corrected calcium > ULN, KPS < 80%, Neutrophil count > ULN and Platelet count > ULN.
Croatian: Kod bolesti srednjeg rizika bila su prisutna jedan ili dva sljedeća čimbenika rizika, dok je kod bolesti lošeg rizika bilo prisutno tri ili više čimbenika: vrijeme od dijagnoze RCC-a do sistemskog liječenja <1 godine, Hgb <DGN, korigirani kalcij >GGN, KPS (Karnofskyjeva ljestvica) <80 %, broj neutrofila >GGN i broj trombocita >GGN.
English: A higher relative proportion of patients with moderate hepatic impairment (Child-Pugh B) developed hepatic encephalopathy with cabozantinib treatment.
Croatian: U relativno većeg udjela bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh B) došlo je do razvoja hepatičke encefalopatije uz liječenje kabozantinibom.
English: Effect of cabozantinib on other medicinal products The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
Croatian: Učinak kabozantiniba na farmakokinetiku kontracepcijskih steroida nije ispitan.
English: Therefore, concomitant use of MRP2 inhibitors (e.g. cyclosporine, efavirenz, emtricitabine) should be approached with caution (see section 4.5).
Croatian: Stoga istodobnoj primjeni inhibitora MRP2 (npr. ciklosporina, efavirenza, emtricitabina) treba pristupiti s oprezom (vidjeti dio 4.5).
English: A 19% increase in the Cmax of the tablet formulation (CABOMETYX) compared to the capsule formulation (COMETRIQ) was observed.
Croatian: Uočen je porast Cmax za 19 % pri primjeni tableta (CABOMETYX) u usporedbi s primjenom kapsula (COMETRIQ).
English: Objective response rate (ORR) findings are summarized in Table 5.
Croatian: Rezultati za stopu objektivnog odgovora (ORR) sažeto su prikazani u tablici 5.
English: What CABOMETYX is and what it is used for
Croatian: Što je CABOMETYX i za što se koristi
English: Sverige/Ruotsi/Svíþjóð Tlf/Puh/Tel/Sími: +46 8 451 60 00
Croatian: Tlf/Puh/Tel/Sími: +46 8 451 60 00
English: Cabozantinib should be used with caution in patients with a history of QT interval prolongation, patients who are taking antiarrhythmics, or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances.
Croatian: Kabozantinib treba oprezno primijeniti u bolesnika s anamnezom produljenja QT intervala, u bolesnika koji uzimaju antiaritmike ili bolesnika s relevantnom prethodno postojećom srčanom bolesti, bradikardijom ili poremećajima ravnoteže elektrolita.
English: 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).
Croatian: Istodobna primjena lijekova koji su jaki inhibitori CYP3A4 mora se provoditi uz oprez, a kronična istodobna primjena lijekova koji su jaki induktori CYP3A4 mora se izbjegavati (vidjeti dijelove 4.4 i 4.5).
English: In the HCC study (CELESTIAL), portal vein thrombosis was observed with cabozantinib, including one fatal event.
Croatian: U ispitivanju HCC-a (CELESTIAL) tromboza portalne vene opažena je s kabozantinibom, uključujući jedan smrtonosni događaj.
English: Cases of hepatic encephalopathy in HCC patients can be attributed to the development of electrolyte disturbances.
Croatian: Slučajevi hepatičke encefalopatije u bolesnika s hepatocelularnim karcinomom mogu se pripisati razvoju poremećaja elektrolita.
English: • Low level of albumin in blood
Croatian: • Niska razina albumina u krvi
English: Consider re-initiating at a reduced dose.
Croatian: Razmotrite ponovno uvođenje liječenja sa smanjenom dozom.
English: Do not use this medicine after the expiry date which is stated on the blister, bottle label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru, naljepnici boce i kutiji iza oznake „Rok valjanosti“.
English: ORR (partial responses only) (95% CI) p-value1
Croatian: ORR (samo parcijalni odgovori) (95 % CI) p-vrijednost1
English: In the 2-year rat carcinogenicity study, cabozantinibrelated neoplastic findings consisted of an increased incidence of benign pheochromocytoma, alone or in combination with malignant pheochromocytoma/complex malignant pheochromocytoma of the adrenal medulla in both sexes at exposures well below the intended exposure in humans.
Croatian: U dvogodišnjem ispitivanju kancerogenosti u štakora, neoplastični nalazi povezani s kabozantinibom sastojali su se od povećane incidencije benignog feokromocitoma, samog ili u kombinaciji s malignim feokromocitomom / kompleksnim malignim feokromocitomom srži nadbubrežne žlijezde u oba spola kod izloženosti koje su znatno niže od predviđene izloženosti u ljudi.
English: The safety and efficacy of CABOMETYX were evaluated in a randomized, double-blind, placebocontrolled Phase 3 study (CELESTIAL).
Croatian: Sigurnost i djelotvornost CABOMETYXA ispitane su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze 3 (CELESTIAL).
English: The results from the Investigator determined analysis and IRC-determined analysis of PFS were consistent.
Croatian: Rezultati analize za PFS koju je proveo ispitivač bili su sukladni rezultatima analize IRC-a.
English: 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.
Croatian: Kabozantinib je mala molekula koja inhibira različite receptorske tirozin kinaze (RTK) povezane s rastom tumora i angiogenezom, patološkom pregradnjom kostiju, rezistencijom na lijek te metastatskom progresijom raka.
English: 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.
Croatian: U ispitivanjima toksičnosti ponovljenih doza u štakora i pasa u trajanju do 6 mjeseci, ciljni organi za toksičnost bili su GI trakt, koštana srž, limfno tkivo, bubreg te nadbubrežno tkivo i tkivo reproduktivnog trakta.
English: Findings in uterus/ovaries and decreased haematopoiesis appeared to be transient, while effects on bone parameters and liver pigmentation were sustained.
Croatian: Promjene na maternici/jajnicima te smanjena hematopoeza pokazale su se prolaznima, dok su učinci na parametre kostiju i pigmentaciju jetre bili dugoročni.
English: Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Croatian: Profili ovisnosti koncentracije u plazmi o vremenu pokazuju drugu vršnu vrijednost apsorpcije otprilike 24 sata nakon primjene, što ukazuje na mogućnost da kabozantinib podliježe enterohepatičkoj cirkulaciji.
English: Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Croatian: Sindrom reverzibilne posteriorne leukoencefalopatije (RPLS)
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
Croatian: CABOMETYX je indiciran za liječenje uznapredovalog karcinoma bubrežnih stanica: - u prethodno neliječenih odraslih bolesnika sa srednjim ili lošim rizikom (vidjeti dio 5.1) - u odraslih, nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (engl. vascular endothelial growth factor, VEGF).
English: Adverse reactions are listed in Table 2 according to MedDRA System Organ Class and frequency categories.
Croatian: U tablici 2 navedene su nuspojave prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
English: When using cabozantinib, periodic monitoring with ontreatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
Croatian: Kada se primjenjuje kabozantinib, treba razmotriti povremeno praćenje EKG-a i elektrolita tijekom liječenja (serumski kalcij, kalij i magnezij).
English: Cabozantinib has been associated with an increased incidence of electrolyte abnormalities (including hypo- and hyperkalaemia, hypomagnesaemia, hypocalcaemia, hyponatremia).
Croatian: Kabozantinib je povezan s povećanom incidencijom abnormalnosti elektrolita (uključujući hipokalijemiju, hiperkalijemiju, hipomagnezemiju, hipokalcijemiju, hiponatrijemiju).
English: Loco-regional transarterial embolisation or chemoinfusion procedures: 44% Radiotherapy prior to cabozantinib treatment: 37% Median duration of sorafenib treatment: 5.32 months
Croatian: Lokoregionalna transarterijska embolizacija ili postupci kemoinfuzije: 44 % Radioterapija prije liječenja kabozantinibom: 37 %
English: • Redness, swelling or pain in the mouth or throat, Difficulty in speaking, hoarseness, cough
Croatian: • Crvenilo, oticanje ili bol u ustima ili grlu, otežan govor, promuklost, kašalj
English: Nervous system disorders dysgeusia, headache, dizziness peripheral sensory neuropathy convulsion cerebrovascul ar accident
Croatian: Poremećaji živčanog sustava disgeuzija, glavobolja, omaglica periferna senzorna neuropatija konvulzije cerebrovaskularni inzult
English: Olbrachtova 2006/9, 140 00 Praha 4
Croatian: Ipsen Pharma, s.r.o., Olbrachtova 2006/9, 140 00 Praha 4
English: 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.
Croatian: Povoljan učinak CABOMETYXA u usporedbi sa sunitinibom pokazao se i u bolesnika s pozitivnim i u onih s negativnim MET-statusom, s time da je veća aktivnost opažena u bolesnika s pozitivnim MET-statusom nego u onih s negativnim MET-statusom (HR=0,32 (0,16; 0,63) naspram 0,67 (0,37; 1,23)).
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4)
Croatian: Napomena: Stupnjevi toksičnosti određeni su u skladu s verzijom 4.0 Zajedničkih kriterija terminologije za nuspojave Nacionalnog instituta za rak (engl.
English: • A burning or stinging sensation of the tongue
Croatian: • Osjećaj žarenja ili bockanja u jeziku
English: • A painful tear or abnormal connection of the tissues in your body
Croatian: • Bolan rascjep ili nenormalni spoj tkiva u organizmu
English: CABOMETYX contains lactose
Croatian: CABOMETYX sadrži laktozu
English: Figure 5: Kaplan Meier curve for progression-free survival (CELESTIAL)
Croatian: Slika 5: Kaplan Meierova krivulja preživljenja bez progresije bolesti (CELESTIAL)
English: Patient distribution by IMDC risk groups was 81% intermediate (1-2 risk factors) and 19% poor (≥3 risk factors).
Croatian: Prema IMDC skupinama rizika, 81 % bolesnika pripadalo je skupini sa srednjim (1-2 čimbenika rizika), a 19 % skupini s lošim rizikom (≥3 čimbenika rizika).
English: 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.
Croatian: Incidencija sistemske terapije protiv karcinoma isključujući zračenja i lokalne sistemske, neprotokolarne terapije protiv karcinoma usmjerene na jetru (NPACT) bila je 26 % u skupini koja je primala kabozantinib i 33 % u skupini koja je primala placebo.
English: Data for the following reactions are based on patients who received Cabometyx 60 mg qd po in the pivotal studies in RCC following prior VEGF-targeted therapy and in treatment-naïve RCC and in HCC following prior systemic therapy (section 5.1).
Croatian: Podaci o sljedećim nuspojavama temelje se na podacima bolesnika koji su primali Cabometyx od 60 mg peroralno jednom dnevno u pivotalnim ispitivanjima RCC-a nakon prethodne terapije usmjerene na VEGF i prethodno neliječenih bolesnika s RCC-om i kod HCC-a nakon prethodne sistemske terapije (dio 5.1).
English: Renal Cell Carcinoma (RCC)
Croatian: Karcinom bubrežnih stanica (engl. renal cell carcinoma, RCC)
English: 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).
Croatian: Bolesnici (N=157) s prethodno neliječenim, lokalno uznapredovalim ili metastatskim RCC-om s komponentom svijetlih stanica bili su randomizirani (1:1) kako bi primali CABOMETYX (N=79) ili sunitinib (N=78).
English: 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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka CABOMETYX u svim podskupinama pedijatrijske populacije u liječenju hepatocelularnog karcinoma, karcinoma bubrega i karcinoma bubrežne nakapnice (osim nefroblastoma, nefroblastomatoze, sarkoma svijetlih stanica, mezoblastičnog nefroma, medularnog karcinoma bubrega i rabdoidnog tumora bubrega) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Patients (N=658) with advanced RCC with a clear cell component who had previously received at least 1 prior VEGF receptor tyrosine kinase inhibitor (VEGFR TKI) were randomized (1:1) to receive CABOMETYX (N=330) or everolimus (N=328).
Croatian: Bolesnici (N=658) s uznapredovalim RCC-om svijetlih stanica koji su prethodno primili najmanje jedan inhibitor receptorske tirozin kinaze VEGF receptora (VEGFR TKI) bili su randomizirani (1:1) kako bi primali CABOMETYX (N=330) ili everolimus (N=328).
English: • Low level of a type of white blood cell (lymphocytes)
Croatian: • Niske razine vrste bijelih krvnih stanica (limfocita)
English: • Feeling drowsy, confused or loss of consciousness due to liver problems
Croatian: • Omamljenost, zbunjenost ili gubitak svijesti zbog problema s jetrom.
English: If you have taken more CABOMETYX than you have been instructed to, talk to a doctor or go to the hospital with the tablets and this leaflet straight away.
Croatian: Vam je rečeno, odmah se obratite liječniku ili otiđite u bolnicu s tabletama i ovom uputom.