FrancophonIA/ELRC3.0 huggingface dataset:
English: Objective Response Rate n (%)3
Croatian: Stopa objektivnog odgovora (ORR) n (%)3
English: Investigations weight decreased, serum ALT increased, AST increased blood ALP increased, GGT increased, blood creatinine increased, amylase increased, lipase increased, blood cholesterol increased, white blood cell count decreased blood triglycerides increased
Croatian: Pretrage smanjenje tjelesne težine, porast ALT-a u serumu, porast AST-a porast ALP-a u krvi, porast GGTa, porast kreatinina u krvi, porast amilaze, porast lipaze, porast kolesterola u krvi, smanjenje broja bijelih krvnih stanica porast triglicerida u krvi
English: Fistulas
Croatian: Fistule
English: The CELESTIAL study excluded patients with concomitant anticoagulation treatment or antiplatelet agents.
Croatian: Iz ispitivanja CELESTIAL bili su isključeni bolesnici koji su istodobno liječeni antikoagulansima ili antitrombocitnim lijekovima.
English: Further, hypospermatogenesis was observed in male dogs at exposure levels below human clinical exposure levels at intended therapeutic dose.
Croatian: Pored toga, zabilježena je hipospermatogeneza u mužjaka pasa pri razinama izloženosti manjima od razina kliničke izloženosti u ljudi pri primjeni predviđene terapijske doze.
English: In a subsequent unplanned interim analysis of OS, a statistically significant improvement was demonstrated for patients randomized to CABOMETYX as compared with everolimus (320 events, median of 21.4 months vs. 16.5 months; HR=0.66 [0.53, 0.83], p=0.0003; Figure 2).
Croatian: U sljedećoj neplaniranoj interim analizi OS-a, pokazalo se statistički značajno poboljšanje u bolesnika randomiziranih na CABOMETYX u usporedbi s everolimusom (320 događaja, medijan od 21,4 mjeseca naspram 16,5 mjeseci; HR=0,66 [0,53; 0,83]; p=0,0003; Slika 2).
English: In the treatment-naïve RCC study (CABOSUN), no cases of fistulas were reported.
Croatian: U ispitivanju prethodno neliječenog RCC-a (CABOSUN) slučajevi fistula nisu zabilježeni.
English: Grade 4 adverse reactions (except clinically nonrelevant laboratory abnormalities)
Croatian: 4. stupanj nuspojava (osim abnormalnih laboratorijskih nalaza koji nisu klinički značajni)
English: A less than 10% difference in the AUC was observed between cabozantinib tablet (CABOMETYX) and capsule (COMETRIQ) formulations.
Croatian: Uočena je razlika u AUC između tableta kabozantiniba (CABOMETYX) i kapsula kabozantiniba (COMETRIQ) manja od 10 %.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: VJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Most patients (87%) had ECOG performance status of 0 or 1; 13% had an ECOG performance status of 2.
Croatian: U većine bolesnika (87 %) ECOG status bio je 0 ili 1; 13 % bolesnika imalo je ECOG status 2. Trideset i šest posto (36 %) bolesnika imalo je koštane metastaze.
English: The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
Croatian: Razina bez primijećenih štetnih učinaka (NOAEL) za ove nalaze bila je manja od razina kliničke izloženosti u ljudi pri predviđenoj terapijskoj dozi.
English: MARKETING AUTHORISATION HOLDER Ipsen Pharma
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Ipsen Pharma
English: Following oral administration of cabozantinib, peak cabozantinib plasma concentrations are reached at 3 to 4 hours post-dose.
Croatian: Nakon peroralne primjene kabozantiniba, vršne koncentracije kabozantiniba u plazmi postignute su za 3 do 4 sata nakon uzimanja doze.
English: The pharmacokinetics of cabozantinib was not evaluated in patients with severe hepatic impairment.
Croatian: Farmakokinetika kabozantiniba nije procijenjena u bolesnika s teškim oštećenjem funkcije bubrega.
English: NOAEL for embryofoetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose.
Croatian: NOAEL za embriofetalnu toksičnost i teratogene nalaze bile su manje od razina kliničke izloženosti u ljudi pri primjeni predviđene terapijske doze.
English: Add supportive care as indicated.
Croatian: Uvedite potporne mjere prema indikacijama.
English: Co-administration of proton pump inhibitor (PPI) esomeprazole (40 mg daily for 6 days) with a single dose of 100 mg cabozantinib to healthy volunteers resulted in no clinically-significant effect on plasma cabozantinib exposure (AUC).
Croatian: Istodobna primjena inhibitora protonske pumpe (IPP) esomeprazola (40 mg dnevno tijekom 6 dana) s jednokratnom dozom od 100 mg kabozantiniba u zdravih dobrovoljaca nije imala klinički značajan učinak na plazmatsku izloženost kabozantinibu (AUC).
English: Patients who have inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, peritonitis, diverticulitis, or appendicitis), have tumour infiltration in the GI tract, or have complications from prior GI surgery (particularly when associated with delayed or incomplete healing) should be carefully evaluated before initiating cabozantinib therapy and subsequently they should be monitored closely for symptoms of perforations and fistulas including abscesses and sepsis.
Croatian: Crohnovu bolest, ulcerozni kolitis, peritonitis, divertikulitis ili apendicitis), imaju infiltraciju GI sustava tumorom ili koji imaju komplikacije prethodne GI operacije (naročito komplikacije koje su povezane s usporenim ili nepotpunim cijeljenjem) mora se napraviti pažljiva procjena prije početka terapije kabozantinibom te ih se, slijedom navedenog, mora pažljivo pratiti zbog moguće pojave simptoma perforacija i fistula uključujući apscese i sepsu.
English: An exploratory OS analysis censoring for the use of NPACT supported the primary analysis: the HR, adjusted for stratification factors (per IxRS), was 0.66 (95% CI: 0.52, 0.84; stratified logrank p-value = 0.0005).
Croatian: Eksplorativna analiza ukupnog preživljenja cenzurirana za upotrebu NPACT-a podržala je primarnu analizu: HR, prilagođen za faktore stratifikacije (prema IxRS), bio je 0,66 (95 % CI: 0,52; 0,84; p-vrijednost = 0,0005 za stratificirani log rang).
English: Predisposing risk factors for severe haemorrhage in the advanced HCC population may include tumour invasion of major blood vessels and the presence of underlying liver cirrhosis resulting in oesophageal varices, portal hypertension, and thrombocytopenia.
Croatian: Predisponirajući faktori nastanka teškog krvarenja u populaciji uznapredovalog hepatocelularnog karcinoma mogu uključivati invaziju tumora u velike krvne žile i prisutnost podležeće ciroze jetre što dovodi do varikoziteta jednjaka, portalne hipertenzije i trombocitopenije.
English: • Abscess (collection of pus, with swelling and inflammation)
Croatian: • Apsces (nakupljanje gnoja s oticanjem i upalom)
English: and 5.2).There is no clinical experience in patients with severe hepatic impairment (Child Pugh C), so cabozantinib is not recommended for use in these patients (see section 5.2).
Croatian: Kliničko iskustvo u bolesnika s teškim oštećenjem funkcije jetre (Child Pugh C) ne postoji, pa se primjena kabozantiniba u tih bolesnika ne preporučuje (vidjeti dio 5.2).
English: A statistically significant improvement in OS was demonstrated for CABOMETYX compared to placebo (Table 6 and Figure 4).
Croatian: Statistički značajno poboljšanje ukupnog preživljenja dokazano je za CABOMETYX u usporedbi s placebom (Tablica 6 i Slika 4).
English: Therefore, chronic administration of agents that are strong CYP3A4 inducers with cabozantinib should be avoided (see sections 4.2 and 4.5).
Croatian: Prema tome, mora se izbjegavati kronična primjena lijekova koji su jaki induktori CYP3A4 s kabozantinibom (vidjeti dijelove 4.2 i 4.5).
English: Caution is required when administering cabozantinib with agents that are strong CYP3A4 inhibitors.
Croatian: Potreban je oprez prilikom primjene kabozantiniba s lijekovima koji su jaki inhibitori CYP3A4.
English: Use caution when driving or using machines.
Croatian: Budite oprezni pri upravljanju vozilima i radu sa strojevima.
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.
Croatian: Obrok s visokim udjelom masti umjereno je povećao Cmax i AUC vrijednosti (41 %, odnosno 57 %) u odnosu na stanje natašte u zdravih dobrovoljaca pri primjeni jedne peroralne doze kabozantiniba od 140 mg.
English: Taking CABOMETYX with food
Croatian: Uzimanje CABOMETYXA s hranom
English: Median time to onset was 14 weeks.
Croatian: Medijan vremena do pojave bio je 14 tjedana.
English: Mean clearance (CL/F) at steady-state was estimated to be 2.48 L/hr .
Croatian: Srednja vrijednost klirensa (CL/F) u stanju dinamičke ravnoteže procijenjena je na 2,48 l/h.
English: • Increased or decreased blood glucose level
Croatian: • Povišena ili snižena razina glukoze u krvi
English: CABOMETYX is a cancer medicine that contains the active substance cabozantinib.
Croatian: Što je CABOMETYX CABOMETYX je lijek protiv raka koji sadrži djelatnu tvar kabozantinib.
English: Grade 3 adverse reactions (except clinically nonrelevant laboratory abnormalities)
Croatian: 3. stupanj nuspojava (osim abnormalnih laboratorijskih nalaza koji nisu klinički značajni)
English: Patients (N=707) with HCC not amenable to curative treatment and who had previously received sorafenib for advanced disease were randomized (2:1) to receive CABOMETYX (N=470) or placebo (N=237).
Croatian: Bolesnici (N=707) s HCC-om, koji ne odgovara na kurativno liječenje, prethodno liječeni sorafenibom radi uznapredovale bolesti randomizirani su (2:1) za primanje lijeka CABOMETYX (N=470) ili placeba (N=237).
English: Reversible posterior leukoencephalopathy syndrome Reversible Posterior Leukoencephalopathy Syndrome (RPLS), also known as Posterior Reversible Encephalopathy Syndrome (PRES), has been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježen je sindrom reverzibilne posteriorne leukoencefalopatije (RPLS), također poznat kao sindrom posteriorne reverzibilne encefalopatije (PRES).
English: In patients with mild hepatic impairment no dose adjustment is required.
Croatian: U bolesnika s blagim oštećenjem funkcije jetre nije potrebna prilagodba doze.
English: Juvenile rats (comparable to a >2 year- old paediatric population) administered cabozantinib showed increased WBC parameters, decreased haematopoiesis, pubescent/immature female reproductive system (without delayed vaginal opening), tooth abnormalities, reduced bone mineral content and density, liver pigmentation and lymph node lymphoid hyperplasia.
Croatian: U mladih štakora (koji su usporedivi s pedijatrijskom populacijom starosti >2 godine) u kojih je primjenjen kabozantinib došlo je do povećanja parametara leukocita, smanjenja hematopoeze, pubescentnog/nezrelog ženskog spolnog sustava (bez odgođenog vaginalnog otvaranja), abnormalnosti zuba, smanjenog mineralnog sadržaja i gustoće kostiju, pigmentacije jetre i limfocitne hiperplazije limfnih čvorova.
English: Primary Analysis ORR IntentTo-Treat Population (IRC)
Croatian: Primarna analiza ORR-a u populaciji s namjerom liječenja prema IRC-u
English: Hepatic encephalopathy
Croatian: Hepatična encefalopatija
English: Infections and infestations abscess
Croatian: Infekcije i infestacije apsces
English: Cardiac disorders myocardial infarction
Croatian: Srčani poremećaji infarkt miokarda
English: In HCC patients with compromised livers, these non-hepatic effects may be precipitating factors for the development of hepatic encephalopathy.
Croatian: U bolesnika s hepatocelularnim karcinomom u kojih je oštećena funkcija jetre, navedeni učinci koji nisu povezani s jetrom mogu biti precipitirajući faktori za razvoj hepatičke encefalopatije.
English: CABOMETYX should not be taken with food.
Croatian: CABOMETYX se ne smije uzimati s hranom
English: Cabozantinib exhibited dose-related tumour growth inhibition, tumour regression, and/or inhibited metastasis in a broad range of preclinical tumour models.
Croatian: Kabozantinib je pokazao inhibiciju rasta tumora ovisnu o dozi, utjecao na regresiju tumora i/ili inhibirao metastaze u širokom spektru pretkliničkih modela tumora.
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
Croatian: 1 2-strani, stratificirani log-rang test s etiologijom bolesti (HBV [s HCV-om ili bez], HCV [bez HBV-a], ili drugo), geografsko područje (Azija, druga područja) i prisutnost ekstrahepatalnog širenja bolesti i/ili makrovaskularnih invazija (Da, Ne) kao faktori stratifikacije (prema IVRS podacima) 2 procijenjeno s pomoću Coxova modela proporcionalnog hazarda 3 kako je procijenio ispitivač prema kriteriju RECIST 1.1
English: In the HCC study (CELESTIAL), hepatic encephalopathy (hepatic encephalopathy, encephalopathy, hyperammonaemic encephalopathy) was reported in 5.6% of cabozantinib-treated patients (26/467); Grade 3-4 events in 2.8%, and one (0.2%) Grade 5 event.
Croatian: U ispitivanju HCC-a (CELESTIAL), hepatična encefalopatija (hepatična encefalopatija, encefalopatija, hiperamonijemična encefalopatija) zabilježena je u 5,6 % bolesnika liječenih kabozantinibom (26/467); događaji od 3. do 4. stupnja u 2,8 % i jedan (0,2 %) događaj 5. stupnja.
English: Hypertension was observed more frequently in the treatment naïve RCC population (67%) compared to RCC patients following prior VEGF-targeted therapy
Croatian: Hipertenzija je bila češće opažena u populaciji prethodno neliječenih bolesnika s RCC-om (67 %) nego u bolesnika s RCC-om prethodno liječenih terapijom usmjerenom na VEGF (37 %).
English: Number at risk: CABOMETYX Everolimus
Croatian: Broj pod rizikom: CABOMETYX Everolimus
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.
Croatian: Postoje ograničeni podaci o bolesnicima s umjerenim oštećenjem funkcije jetre (n=15) prema kriteriju NCI-ODWG (engl.
English: Within a 48-day collection period after a single dose of 14C-cabozantinib in healthy volunteers, approximately 81% of the total administered radioactivity was recovered with 54% in faeces and 27% in urine.
Croatian: kabozantiniba u zdravih dobrovoljaca, otprilike 81 % od ukupno primijenjene radioaktivnosti je izlučeno, od čega 54 % fecesom i 27 % urinom.
English: ORR per Investigator Review Intent-To-Treat Population
Croatian: ORR u populaciji s namjerom liječenja prema procjeni ispitivača
English: Events that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmar-plantar erythrodysaesthesia syndrome (PPES), proteinuria, and gastrointestinal (GI) events (abdominal pain, mucosal inflammation, constipation, diarrhoea, vomiting).
Croatian: Događaji koji se uglavnom javljaju rano uključuju hipokalcijemiju, hipokalijemiju, trombocitopeniju, hipertenziju, sindrom palmarno-plantarne eritrodizestezije (PPES), proteinuriju i gastrointestinalne (GI) događaje (bol u abdomenu, upalu sluznice, konstipaciju, proljev, povraćanje).
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,
Croatian: - imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvnih žila) ili razdor u stijenci krvnih žila - imate proljev - ste nedavno imali značajno krvarenje - ste bili na operaciji u zadnjih mjesec dana (ili ako se planiraju kirurški zahvati), uključujući dentalne zahvate - imate upalnu bolest crijeva (na primjer, Crohnovu bolest ili ulcerozni kolitis, divertikulitis ili apendicitis) - ste nedavno imali krvni ugrušak u nozi, moždani ili srčani udar - imate bolest jetre ili bubrega.
English: 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.
Croatian: Interactive Voice/Web Response System - interaktivni sustav govornog/mrežnog odgovora) obuhvaćaju IMDC kategorije rizika (srednji rizik, loš rizik i koštane metastaze (da, ne)) c Procijenjeno na temelju Coxova modela proporcionanog hazarda prilagođenog za faktore stratifikacije prema IxRS.
English: Primary PFS analysis Population Intent-To-Treat Population
Croatian: Populacija za primarnu analizu PFS-a
English: Ipsen Pharma, S.A.
Croatian: España Ipsen Pharma, S.A.
English: Therefore, co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Croatian: Stoga se istodobna primjena jakih inhibitora CYP3A4 (npr. ritonavira, itrakonazola, eritromicina, klaritromicina, soka od grejpa) s kabozantinibom mora provoditi uz oprez.
English: The baseline demographic and disease characteristics were similar between the CABOMETYX and sunitinib arms.
Croatian: Početni demografski podaci i karakteristike bolesti u skupinama koje su primale CABOMETYX i sunitinib bili su slični.
English: Median time to onset was 20.9 weeks.
Croatian: Medijan vremena do pojave bio je 20,9 tjedana.
English: Median time to onset was 30.3 weeks.
Croatian: Medijan vremena do pojave bio je 30,3 tjedna.
English: Platelet levels should be monitored during cabozantinib treatment and the dose modified according to the severity of the thrombocytopenia (see Table 1).
Croatian: Potrebno je pratiti razine trombocita tijekom liječenja kabozantinibom te prilagoditi dozu u skladu s težinom trombocitopenije (vidjeti Tablicu 1).
English: Dose interruption or reduction, or permanent discontinuation of cabozantinib should be considered in case of persistent or recurrent significant abnormalities (see Table 1).
Croatian: Potrebno je razmotriti privremeni prekid doziranja ili smanjenje doze ili pak trajni prekid doziranja kabozantiniba u slučaju perzistentnih ili rekurentnih značajnih abnormalnosti (vidjeti Tablicu 1).
English: When PPES is severe, interruption of treatment with cabozantinib should be considered.
Croatian: U teškim slučajevima PPES-a mora se razmotriti prekid liječenja kabozantinibom.
English: Subjects with severe renal impairment have not been studied.
Croatian: Ispitanici s teškim oštećenjem funkcije bubrega nisu ispitivani.
English: • Pain in arms, legs and joints, muscle spasms
Croatian: • Bol u rukama, nogama i zglobovima, grčenje mišića
English: For RCC and HCC, the recommended dose of CABOMETYX is 60 mg once daily.
Croatian: Preporučena doza CABOMETYXA za karcinom bubrežnih stanica i hepatocelularni karcinom je 60 mg jednom dnevno.
English: • Reduced thyroid activity; symptoms can include: tiredness, weight gain, constipation, feeling cold and dry skin
Croatian: • Smanjena aktivnost štitnjače; simptomi mogu uključivati: umor, dobivanje na tjelesnoj težini,
English: In the HCC study (CELESTIAL), fistulas were reported in 1.5% (7/467) of the HCC patients.
Croatian: U ispitivanju HCC-a (CELESTIAL), fistule su zabilježene u 1,5 % (7/467) bolesnika s HCC-om.
English: • Numbness, tingling, burning sensation or pain in the limbs
Croatian: • Utrnulost, trnci, žarenje ili bol u udovima
English: A statistically significant improvement in PFS was demonstrated for CABOMETYX compared to everolimus (Figure 1 and Table 3).
Croatian: Pokazalo se statistički značajno poboljšanje PFS-a za CABOMETYX u usporedbi s everolimusom (Slika 1 i Tablica 3).
English: The safety and efficacy of CABOMETYX for the treatment of renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy were evaluated in a randomized, openlabel, multicenter Phase 3 study (METEOR).
Croatian: Sigurnost i djelotvornost CABOMETYXA u liječenju karcinoma bubrežnih stanica nakon prethodne terapije usmjerene na vaskularni endotelni faktor rasta (VEGF) procijenjene su u randomiziranom, multicentričnom, otvorenom ispitivanju faze 3 (METEOR).
English: Patients had to have intermediate or poor risk disease as defined by the International Metastatic RCC Database Consortium (IMDC) risk group categories.
Croatian: Everolimus imati bolest srednjeg ili lošeg rizika prema kategorijama skupina rizika kako ih definira Međunarodni konzorcij za bazu podataka o metastatskom karcinomu bubrežnih stanica (engl.
English: In rabbits, cabozantinib produced foetal soft tissue changes (reduced spleen size, small or missing intermediate lung lobe) and increased foetal incidence of total malformations.
Croatian: U kunića je kabozantinib uzrokovao promjene u mekom tkivu fetusa (smanjena veličina slezene, smanjenje ili gubitak srednjeg režnja pluća) te povećanu incidenciju ukupnih malformacija u fetusa.
English: Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors.
Croatian: Ispitivano je inhibitorno djelovanje kabozantiniba na razne kinaze te se ustanovilo da je kabozantinib inhibitor MET (receptor za faktor rasta hepatocita) i VEGF (vaskularni endotelni faktor rasta) receptora.
English: The safety and efficacy of CABOMETYX for the treatment of treatment-naïve renal cell carcinoma were evaluated in a randomized, open-label, multicenter study (CABOSUN).
Croatian: Sigurnost i djelotvornost CABOMETYXA za liječenje prethodno neliječenog karcinoma bubrežnih stanica procijenjene su u randomiziranom, otvorenom, multicentričnom ispitivanju (CABOSUN).
English: • Low level of platelets and white blood cells
Croatian: • Niske razine trombocita i bijelih krvnih stanica
English: Gastrointestinal disorders diarrhoea, nausea, vomiting, stomatitis, constipation, abdominal pain, dyspepsia, upper abdominal pain gastrointestinal perforation, fistula, gastroesophageal reflux disease, haemorrhoids, oral pain, dry mouth pancreatitis, glossodynia
Croatian: Poremećaji probavnog sustava proljev, mučnina, povraćanje, stomatitis, konstipacija, bol u abdomenu, dispepsija, bol u gornjem dijelu abdomena gastrointestinalna perforacija, fistula, gastroezofagealna refluksna bolest, hemoroidi, bol u ustima, suha usta pankreatitis, glosodinija
English: Cabozantinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Croatian: Kabozantinib se mora primjenjivati s oprezom u bolesnika koji imaju povećan rizik od ovakvih događaja ili ih imaju u anamnezi.
English: The baseline demographic and disease characteristics were similar between the CABOMETYX and everolimus arms.
Croatian: Početni demografski podaci i karakteristike bolesti u skupinama koje su primale CABOMETYX i everolimus bili su slični.
English: In the HCC study (CELESTIAL), thrombocytopenia and decreased platelets were reported.
Croatian: U ispitivanju HCC-a (CELESTIAL), prijavljene su trombocitopenija i snižene razine trombocita.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 28 film-coated tablets 30 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: OBLIK I SADRŽAJ Filmom obložena tableta 28 filmom obloženih tableta 30 filmom obloženih tableta NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena kroz usta.
English: Metabolism and nutrition disorders decreased appetite, hypomagnesaemia, hypokalaemia dehydration, hypoalbuminaemia, hypophosphataemia, hyponatraemia, hypocalcaemia, hyperkalaemia, hyperbilirubinemia hyperglycaemia, hypoglycaemia
Croatian: dehidracija, hipoalbuminemija, hipofosfatemija, hiponatrijemija, hipokalcijemija, hiperkalijemija, hiperbilirubinemija, hiperglikemija, hipoglikemija
English: In case of hypertensive crisis, cabozantinib should be discontinued.
Croatian: Ako se javi hipertenzivna kriza, primjena kabozantiniba mora se prekinuti.