FrancophonIA/ELRC3.0 huggingface dataset:
English: Put the used syringe in the puncture-proof container.
Slovenian: Uporabljeno brizgo odložite v vsebnik, odporen proti vbodom.
English: Immediate discontinuation of therapy, careful observation, and initiation of appropriate supportive measures (blood transfusions, dialysis, haemofiltration, anti-infectious therapy, etc.) are the indicated treatment of overdose of cladribine.
Slovenian: Specifičnega antidota ni. Indicirano zdravljenje za preveliko odmerjanje kladribina so takojšnja prekinitev zdravljenja, skrbno opazovanje in uvedba ustreznih podpornih ukrepov (transfuzije krvi, dializa, hemofiltracija, zdravljenje proti okužbi, itd.).
English: Very common: headache, dizziness Common: insomnia, anxiety
Slovenian: Zelo pogosti: glavobol, omotica Pogosti: nespečnost, tesnoba
English: The cytotoxicity of cladribine is dose-dependent.
Slovenian: Citotoksičnost kladribina je odvisna od odmerka.
English: You should not father a child during treatment and up to 6 months after treatment with LITAK.
Slovenian: Med zdravljenjem z zdravilom LITAK in do 6 mesecev po zdravljenju z njim ne smete spočeti otroka.
English: Put used syringes into a puncture-proof container and keep it out of the reach and sight of children.
Slovenian: Uporabljene brizge odlagajte v vsebnik, odporen proti vbodom, in ga shranjujte nedosegljivega otrokom.
English: You must not breast-feed while you are treated with LITAK and for at least six months after your last LITAK dose.
Slovenian: Med zdravljenjem z zdravilom LITAK in vsaj še šest mesecev po zadnjem odmerku zdravila LITAK ne smete dojiti.
English: - The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid
Slovenian: - Druge sestavine so natrijev klorid, natrijev hidroksid (za uravnavanje pH), klorovodikova kislina (za uravnavanje pH) n voda za injekcije.
English: Rare: renal failure
Slovenian: Redki: odpoved ledvic
English: Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine (see sections 4.6 and 5.3).
Slovenian: Priporočeno je, da si poiščejo svetovanje o kriokonservaciji sperme pred zdravljenjem zaradi možnosti neplodnosti kot posledice zdravljenja s kladribinom (glejte poglavji 4.6 in 5.3).
English: Each ml of solution contains 2 mg of cladribine (2-CdA).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 2 mg kladribina (2-CdA).
English: Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine (see section 4.4).
Slovenian: Priporočeno je, da si poiščejo svetovanje o kriokonservaciji sperme pred zdravljenjem zaradi možnosti neplodnosti kot posledice zdravljenja s kladribinom (glejte poglavje 4.4).
English: 9/l) are observed in about 20% to 30% of all patients.
Slovenian: Pri približno 20 % do 30 % vseh bolnikov opažamo hude trombocitopenije (< 50 x 10
English: The use of disposable gloves and protective garments is recommended when handling and administering LITAK.
Slovenian: Pri ravnanju in dajanju zdravila LITAK priporočamo uporabo rokavic za enkratno uporabo in zaščitnih oblačil.
English: Very common: purpura Common: petechiae, haemorrhages * Uncommon: phlebitis
Slovenian: Zelo pogosti: purpura Pogosti: petehija, krvavitve * Občasni: flebitis
English: Cladribine is a cytostatic agent.
Slovenian: Kladribin je citostatično zdravilo.
English: An increased incidence of opportunistic infections is expected during, and for 6 months following, therapy with cladribine.
Slovenian: Med zdravljenjem in 6 mesecev po zdravljenju s kladribinom pričakujemo povišano pojavnost oportunističnih okužb.
English: Acute, irreversible neuro- and nephrotoxicity have been described in individual patients treated at a dose which was ≥ 4 times higher than the recommended regimen for hairy cell leukaemia.
Slovenian: Pri posameznih bolnikih, zdravljenih v odmerku, ki je bil ≥ 4-krat višji kot priporočeni režim zdravljenja za dlakavocelično levkemijo, so opisovali akutno, ireverzibilno nevro- in nefrotoksičnost.
English: LITAK should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Zdravilo LITAK pred dajanjem vizualno preglejte, če vsebuje delce ali če je raztopina obarvana.
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Videz parenteralnih zdravil je treba pred dajanjem vizualno pregledati, da ugotovite morebitne trdne delce in spremembo barve.
English: Careful and regular monitoring of peripheral blood counts is essential during, and for 2 to 4 months following, treatment with cladribine to detect potential adverse reactions and consequent complications (anaemia, neutropenia, thrombocytopenia, infections, haemolysis or bleedings), and to survey haematologic recovery.
Slovenian: Za odkrivanje možnih neželenih učinkov in posledičnih zapletov (anemija, nevtropenija, trombocitopenija, okužbe, hemoliza ali krvavitve) ter za nadzor hematološkega okrevanja je nujno skrbno in redno spremljanje koncentracij krvnih celic periferne krvi med zdravljenjem s kladribinom in 2 do 4 mesece po njem.
English: Very common: injection site reactions, fever, fatigue, chills, asthenia
Slovenian: Zelo pogosti: reakcije na mestu injiciranja, zvišana telesna temperatura, utrujenost, mrazenje, astenija Pogosti: edem, izčrpanost, bolečine
English: Rare: apoplexy, neurological disturbances in speech and swallowing
Slovenian: Redki: apopleksija, nevrološke motnje govora in požiranja Zelo redki: depresija, epileptični napad
English: You must take adequate contraceptive precautions during therapy and for at least six months after your last LITAK dose.
Slovenian: Med zdravljenjem in vsaj še šest mesecev po zadnjem odmerku zdravila LITAK morate uporabljati učinkovito kontracepcijo.
English: How to store LITAK
Slovenian: Shranjevanje zdravila LITAKA
English: LITAK should warm up to room temperature prior to administration.
Slovenian: Zdravilo LITAK pred dajanjem ogrejete na sobno temperaturo.
English: - one vial of LITAK (or two vials if you need to inject more than 5 ml).
Slovenian: Če si želite sami podkožno injicirati zdravilo, potrebujete: - eno vialo zdravila LITAK (ali dve viali, če si morate injicirati več kot 5 ml) Ne uporabljajte vial, ki so poškodovane, ali če opazite, da raztopina ni bistra ali vsebuje kakršne koli delce.
English: LITAK can be self-administered by the patient.
Slovenian: Zdravilo LITAK si lahko bolnik da sam. Bolniku je treba dati ustrezna navodila in ga izuriti.
English: Sleepiness, numbness and tingling of the skin, feebleness, inactivity, disorder of peripheral nerves, confusion, impaired ability to coordinate movements.
Slovenian: Občasni neželeni učinki (pojavijo se pri manj kot 1 do 100 bolnikih) anemija zaradi uničenja rdečih krvnih celic zaspanost, otrplost in mravljinčenje kože, šibkost, neaktivnost, motnje perifernega živčevja, zmedenost, slabša sposobnost koordiniranih gibov vnetje oči vnetje grla vnetje žile velika izguba telesne mase
English: Very common: immunosuppression * Rare: graft-versus-host disease *
Slovenian: Zelo pogosti: imunosupresija *
English: Detailed instructions are contained in the Package Leaflet.
Slovenian: Podrobna navodila za dajanje so v navodilu za uporabo zdravila.
English: Tabulated list of adverse reactions
Slovenian: Povzetek neželenih učiknov v preglednici
English: Very common: infections * (e.g. pneumonia *, septicaemia *)
Slovenian: Infekcijske in parazitske bolezni Zelo pogosti: okužbe * (npr. pljučnica *, septikemija *) Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
English: Low numbers of certain white blood cells (neutrophils and lymphocytes) and platelets in blood tests.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov) okužbe zvišana telesna temperatura nizko število nekaterih belih krvnih celic (nevtrofilcev in limfocitov) ter trombocitov pri krvnih testih nizko število rdečih krvnih celic, kar lahko povzroči anemijo s simptomi kot sta utrujenost in zaspanost.
English: Eye inflammation.
Slovenian: Očesne bolezni
English: Very rare side effects (may affect up to 1 in 10.000 people) Depression, epileptic attack.
Slovenian: Zelo redki neželeni učinki (pojavijo se pri manj kot 1 od 10.000 bolnikov) depresija, epileptični napad oteklost veke krvni strdek v pljučih vnetje žolčnika zmanjšano delovanje organov zaradi visokih količin določene snovi, ki jo proizvaja telo (glikoproteina)
English: Always use LITAK as your doctor has told you.
Slovenian: Pri uporabi zdravila LITAK natančno upoštevajte navodila zdravnika.
English: Feeling sick, vomiting, constipation and diarrhoea.
Slovenian: Bolezni jeter, žolčnika in žolčevodov
English: Very common: decreased appetite Uncommon: cachexia
Slovenian: Redki: bolezen graft-versus-host * Presnovne in prehranske motnje Zelo pogosti: zmanjšan apetit Občasni: kaheksija
English: • Ringing in ears
Slovenian: • zvonjenje v ušesih
English: In case of such combination, INR values should be monitored.
Slovenian: Pri takšni kombinaciji je treba spremljati vrednosti INR.
English: Swallow the tablet with a full glass of water.
Slovenian: Tableto pogoltnite s polnim kozarcem vode.
English: Dose adjustment is usually not required.
Slovenian: Prilagoditev odmerjanja običajno ni potrebna.
English: Add supportive care as indicated.
Slovenian: Uvedite podporno oskrbo, kot je indicirano.
English: Median age: 64 years.
Slovenian: Mediana starost: 64 let.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Slovenian: Zdravniku takoj povejte, če opazite katerega od naslednjih neželenih učinkov - morda boste potrebovali nujno medicinsko pomoč:
English: Interrupt treatment.
Slovenian: Prekinite zdravljenje.
English: When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.
Slovenian: Če je treba odmerek zmanjšati, se priporoča zmanjšanje na 40 mg na dan in nato na 20 mg na dan.
English: • Protein in urine (seen in tests)
Slovenian: • beljakovine v urinu (razvidno iz preiskav)
English: One event was Grade 3; the remainder were Grade 2.
Slovenian: En dogodek je bil 3. stopnje; ostali dogodki so bili 2. stopnje.
English: 1 stratified log-rank test
Slovenian: 1 stratificirani test log-rank
English: As most events occur early in the course of treatment, the physician should evaluate the patient closely during the first eight weeks of treatment to determine if dose modifications are warranted.
Slovenian: Ker se večina dogodkov pojavi zgodaj v teku zdravljenja, mora zdravnik bolnika v prvih osmih tednih zdravljenja skrbno spremljati, da oceni, ali je treba odmerek prilagoditi.
English: Perforations and fistulas
Slovenian: Perforacije in fistule
English: Two dose reductions were required in 19.3% of patients.
Slovenian: Dve zmanjšanji odmerka sta bili potrebni pri 19,3 % bolnikov.
English: Partial responses
Slovenian: Delni odzivi
English: Not known (proportion of people affected not known)
Slovenian: Neznana pogostnost (delež prizadetih bolnikov ni znan)
English: Frequencies are based on all grades and defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); not known (cannot be estimated from the available data).
Slovenian: Pogostnosti temeljijo na vseh stopnjah in so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The effects of CABOMETYX in people younger than 18 years old are not known.
Slovenian: Učinki zdravila CABOMETYX pri ljudeh, mlajših od 18 let, niso znani.
English: This effect was not associated with a change in cardiac wave form morphology or new rhythms.
Slovenian: Ta učinek ni povezan s spremembo morfologije oblike zobcev srca ali novimi ritmi.
English: Caucasian: 56%, Asian: 34%
Slovenian: Belci: 56 %, Azijci: 34 %.
English: Male: 82%
Slovenian: Moški spol: 82 %.
English: Partial Response Median time to First Response, months (95% CI) Stable Disease as Best Response Progressive Disease as Best Response 1 chi-squared test
Slovenian: Delni odziv Mediani čas do prvega odziva, meseci (95-% IZ) Stabilna bolezen kot najboljši odziv Napredujoča bolezen kot najboljši odziv 1 test hi-kvadrat
English: 4 stratified Cochran-Mantel-Haenszel (CMH) test
Slovenian: 4 stratificirani Cochran-Mantel-Haenszel-ov (CMH) test
English: Institute appropriate medical care.
Slovenian: Uvedite ustrezno zdravniško oskrbo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 September 2016
Slovenian: Datum prve odobritve: 09. september 2016
English: The results from the Investigator determined analysis and IRC-determined analysis of PFS were consistent.
Slovenian: Rezultati analize raziskovalcev in analize IRC so bili konsistentni.
English: • Dry mouth and pain in the mouth
Slovenian: • suha usta in bolečina v ustih
English: You should tell your doctor about every medicine, but in particular if taking:
Slovenian: Zdravniku morate povedati za vsako zdravilo, ki ga jemljete, še zlasti:
English: Cabozantinib treatment should be stopped at least 28 days prior to scheduled surgery, including dental surgery, if possible.
Slovenian: Zdravljenje s kabozantinibom je treba ustaviti vsaj 28 dni pred načrtovanim kirurškim posegom, vključno z zobozdravstvenim, če je mogoče.
English: The clinical relevance of the observed neoplastic lesions in rats is uncertain, but likely to be low.
Slovenian: Klinični pomen opaženih neoplastičnih sprememb pri podganah je negotov, a po vsej verjetnosti majhen.
English: Two dose reductions were required in 33% of patients.
Slovenian: Dve zmanjšanji odmerka sta bili potrebni pri 33 % bolnikov.
English: The tablets should be swallowed whole and not crushed.
Slovenian: Tablete je treba pogoltniti cele in jih ni dovoljeno drobiti.
English: CABOMETYX is not recommended for children or adolescents.
Slovenian: Uporaba zdravila CABOMETYX se ne priporoča za otroke in mladostnike.
English: Complete responses (CR) Partial responses (PR) ORR (CR+PR)) p-value1,4
Slovenian: Popolni odzivi (CR) Delni odzivi (PR) ORR (CR+PR) p-vrednost1,4
English: There is no information on the precise food-effect when taken 1 hour after administration of cabozantinib.
Slovenian: Ni informacij o natančnem učinku hrane, če se uporabi 1 uro po dajanju kabozantiniba.
English: • Increase in the level of bilirubin in the blood (which may result in jaundice/yellow skin or eyes)
Slovenian: • zvišanje ravni bilirubina v krvi (kar lahko povzroči zlatenico/rumeno obarvanje kože ali očesnih beločnic)
English: The carcinogenic potential of cabozantinib has been evaluated in two species: rasH2 transgenic mice and Sprague-Dawley rats.
Slovenian: Kancerogeni potencial kabozantiniba so vrednotili pri dveh vrstah: rasH2 transgenih miših in podganah pasme Sprague-Dawley.
English: Keep in mind that treatment with CABOMETYX may make you feel tired or weak and can affect your ability to drive or use machines.
Slovenian: Ne pozabite, da lahko zdravljenje z zdravilom CABOMETYX povzroči utrujenost ali šibkost, kar lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
English: Approximately 75% of patients had a nephrectomy prior to onset of treatment.
Slovenian: Pred začetkom zdravljenja je imelo približno 75 % bolnikov opravljeno nefrektomijo.
English: Gastrointestinal (GI) perforation
Slovenian: Gastrointestinalna (GI) perforacija
English: Patients should be monitored for signs and symptoms of hepatic encephalopathy.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov jetrne encefalopatije.
English: • A wound that does not heal.
Slovenian: • rana, ki se ne celi
English: Number at risk:
Slovenian: Število izpostavljenih tveganju:
English: Tumor assessments were conducted every 8 weeks for the first 12 months, then every 12 weeks thereafter.
Slovenian: Vrednotenje tumorja so prvih 12 mesecev opravili vsakih 8 tednov, nato pa vsakih 12 tednov.
English: Tumor assessments were conducted every 12 weeks.
Slovenian: Vrednotenje tumorja je bilo opravljeno vsakih 12 tednov.
English: Talk to your doctor about which methods of contraception are appropriate while you are taking CABOMETYX (see also under Other medicines and CABOMETYX, above).
Slovenian: S svojim zdravnikom se posvetujte o metodah kontracepcije, ki so ustrezne med uporabo zdravila CABOMETYX (glejte tudi zgoraj pod Druga zdravila in zdravilo CABOMETYX).
English: If you get serious side effects, your doctor may decide to change your dose or stop treatment earlier than originally planned.
Slovenian: Če dobite resne neželene učinke, bo morda zdravnik spremenil odmerek ali zdravljenje ustavil prej, kot je bilo načrtovano.
English: Non-disease specific quality of life (QoL) was assessed using the EuroQoL EQ-5D-5L.
Slovenian: Ovrednotena je bila za bolezen nespecifična kakovost življenja s pomočjo vprašalnika EuroQoL EQ5D-5L.
English: • Gastro-oesophageal reflux disease (bringing up stomach acid)
Slovenian: • gastroezofagealna refluksna bolezen (dvigovanje želodčne kisline)
English: This syndrome should be considered in any patient presenting with multiple symptoms, including seizures, headache, visual disturbances, confusion or altered mental function.
Slovenian: Na ta sindrom je treba pomisliti pri vseh bolnikih s številnimi prisotnimi simptomi, vključno z epileptičnimi napadi, glavobolom, motnjami vida, zmedenostjo ali spremenjenim mentalnim delovanjem.
English: • Changes in blood tests used to monitor general health and function of your organs (including the liver, and kidney), low levels of electrolytes (like magnesium, or potassium)
Slovenian: • spremembe krvnih preiskav, ki se uporabljajo za spremljanje splošnega zdravja in delovanja organov (vključno z jetri in ledvicami), nizke ravni elektrolitov (kot sta magnezij in kalij)
English: Because oral contraceptives might possibly not be considered as “effective methods of contraception”, they should be used together with another method, such as a barrier method (see section 4.5).
Slovenian: Ker se morda peroralni kontraceptivi ne obravnavajo kot "zanesljiv način kontracepcije", jih je treba uporabiti skupaj s še eno metodo, na primer pregradno metodo (glejte poglavje 4.5).
English: Subjects with severe renal impairment have not been studied.
Slovenian: Oseb s hudo okvaro ledvic niso preučevali.
English: Your doctor may also prescribe other medicines to help control your side effects.
Slovenian: Zdravnik vam bo morda predpisal tudi druga zdravila za obvladovanje neželenih učinkov.
English: If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Slovenian: Če lahko vi ali vaša partnerica zanosite, morate med zdravljenjem in še vsaj 4 mesece po koncu zdravljenja uporabljati ustrezno kontracepcijo.
English: If you take CABOMETYX whilst using oral contraceptives, the oral contraceptives may be ineffective.
Slovenian: Če jemljete zdravilo CABOMETYX med uporabo peroralnih kontraceptivov, so lahko peroralni kontraceptivi neučinkoviti.
English: • Anaemia (low levels of red blood cells)
Slovenian: • anemija (nizka raven rdečih krvnih celic)
English: • A painful tear or abnormal connection of the tissues in your body
Slovenian: • boleča raztrganina ali nenormalna spojitev tkiv v telesu
English: The safety and efficacy of cabozantinib in children and adolescents aged <18 years have not yet been established.
Slovenian: Varnost in učinkovitost kabozantiniba pri otrocih, starih < 18 let, še nista bili dokazani.
English: The median time to first dose reduction was 55 days, and to first dose interruption was 38 days.
Slovenian: Mediani čas do prvega zmanjšanja odmerka je bil 55 dni, do prve prekinitve odmerjanja pa 38 dni.
English: Treatment Modification
Slovenian: Prilagajanje zdravljenja
English: RPLS is rare (it affects less than 1 in 1000 people).
Slovenian: RPLS je redek neželeni učinek (pojavi se pri manj kot 1 od 1.000 bolnikov).
English: Patients could have received other prior therapies, including cytokines, and antibodies targeting VEGF, the programmed death 1 (PD-1) receptor, or its ligands.
Slovenian: Bolniki so lahko pred tem prejemali druge oblike terapij, vključno s citokini in protitelesi, ki ciljajo VEGF, receptorje programirane smrti 1 (PD-1) ali njihove ligande.
English: Grade 2 adverse reactions which are intolerable and cannot be managed with a dose reduction or supportive care
Slovenian: Neželeni učinki 2. stopnje, ki jih bolnik ne prenaša in jih ni mogoče obravnavati z zmanjšanjem odmerka ali podporno oskrbo
English: Your doctor will tell you if you need your dose adjusted.
Slovenian: Vaš zdravnik vam bo povedal, ali je treba odmerek prilagoditi.
English: Objective response rate findings are summarized in Table 4.
Slovenian: Izsledki stopnje objektivnega odziva so povzeti v preglednici 4.
English: It is not known whether cabozantinib and/or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se kabozantinib in/ali njegovi presnovki izločajo v materino mleko.
English: Kaplan-Meier landmark estimates of percent of subjects event-free at 3 months % (95% CI)
Slovenian: Kaplan-Meierjevi landmark oceni odstotka oseb brez dogodka v 3. mesecu % (95-% IZ)
English: These proteins can be present in high amounts in cancer cells, and by blocking their action CABOMETYX can slow down the rate at which the tumour grows and help to cut off the blood supply that the cancer needs.
Slovenian: Te beljakovine so lahko v rakavih celicah prisotne v velikih količinah, zato lahko zdravilo CABOMETYX z zavrtjem njihove aktivnosti upočasni hitrost rasti tumorja in pomaga prekiniti oskrbo krvi, ki jo potrebuje rak.
English: Avoid consuming grapefruitcontaining products for as long as you are using this medicine, as they may increase the levels of CABOMETYX in your blood.
Slovenian: Dokler uporabljate to zdravilo, ne jejte živil, ki vsebujejo grenivko, saj lahko zvišajo ravni zdravila CABOMETYX v krvi.
English: The median time to first dose reduction was 38 days, and to first dose interruption was 28 days.
Slovenian: Mediani čas do prvega zmanjšanja odmerka je bil 38 dni, do prve prekinitve odmerjanja pa 28 dni.
English: Seventy-one percent (71%) received only one prior VEGFR TKI; 41% of patients received sunitinib as their only prior VEGFR TKI.
Slovenian: Enainsedemdeset odstotkov (71 %) je pred tem prejelo le en VEGFR TKI; 41 % bolnikov je prejelo sunitinib kot edini prejšnji VEGFR TKI.
English: Women taking CABOMETYX should not breast-feed during treatment and for at least 4 months after treatment has finished, as cabozantinib and/or its metabolites may be excreted in breast milk and be harmful to your child.
Slovenian: Ženske, ki jemljejo zdravilo CABOMETYX, med zdravljenjem in še vsaj 4 mesece po koncu zdravljenja ne smejo dojiti, saj se lahko kabozantinib in/ali njegovi presnovki izločajo v materino mleko in škodujejo otroku.
English: Primary Analysis ORR IntentTo-Treat Population (IRC)
Slovenian: Primarna analiza ORR populacije z namenom zdravljenja (IRC)
English: No dose adjustment is necessary based on ethnicity (see section 5.2)
Slovenian: Na osnovi etničnega porekla odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Fifty-four percent (54%) of patients had 3 or more organs with metastatic disease, including lung (63%), lymph nodes (62%), liver (29%), and bone (22%).
Slovenian: Štiriinpetdeset odstotkov (54 %) bolnikov je imelo 3 organe ali več z metastatsko boleznijo, vključno s pljuči (63 %), bezgavkami (62 %), jetri (29 %) in kostmi (22 %).
English: This is because CABOMETYX can affect the way some other medicines work.
Slovenian: Zdravilo CABOMETYX lahko namreč vpliva na način delovanja nekaterih drugih zdravil.