FrancophonIA/ELRC3.0 huggingface dataset:
English: • Severe or uncontrollable bleeding with symptoms such as: vomiting blood, black stolls, bloody urine, headache, coughing up blood.
Slovenian: • resna ali nenadzorovana krvavitev s simptomi, kot so: bruhanje krvi, črno blato, krvav urin, glavobol, izkašljevanje krvi
English: Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with CABOMETYX.
Slovenian: Zdravniku povejte, če vi ali vaša partnerica zanosite ali načrtujete zanositev med zdravljenjem z zdravilom CABOMETYX.
English: Patients who have a history of severe bleeding prior to treatment initiation should be carefully evaluated before initiating cabozantinib therapy.
Slovenian: Bolnike z anamnezo hude krvavitve pred uvedbo zdravljenja je treba pred uvedbo zdravljenja s kabozantinibom skrbno oceniti.
English: The median duration of treatment was 7.6 months (range 0.3 - 20.5) for patients receiving CABOMETYX and 4.4 months (range 0.21 - 18.9) for patients receiving everolimus.
Slovenian: Mediano trajanje zdravljenja je bilo 7,6 meseca (razpon od 0,3 do 20,5) za bolnike, ki so dobivali zdravilo CABOMETYX, in 4,4 meseca (razpon od 0,21 do 18,9) za bolnike, ki so dobivali everolimus.
English: Diarrhoea, nausea/vomiting, decreased appetite, and stomatitis/oral pain were some of the most commonly reported GI adverse reactions (see section 4.8).
Slovenian: Driska, navzea/bruhanje, zmanjšanje apetita in vnetje ustne sluznice/bolečina v ustni votlini so nekateri od najpogosteje poročanih neželenih učinkov na prebavila (glejte poglavje 4.8).
English: Subjects continued blinded study treatment after radiological disease progression whilst they experienced clinical benefit or until the need for subsequent systemic or liver directed local anticancer therapy.
Slovenian: Osebe so nadaljevale slepo zdravljenje v študiji po radiološko potrjenem napredovanju bolezni, če je bila prisotna klinična korist ali do potrebe po naknadnem sistemskem ali v jetra usmerjenem lokalnem protitumorskem zdravljenju.
English: CABOMETYX (cabozantinib) tablets and COMETRIQ (cabozantinib) capsules are not bioequivalent and should not be used interchangeably (see section 5.2).
Slovenian: Zdravili CABOMETYX (kabozantinib) tablete in COMETRIQ (kabozantinib) kapsule nista bioekvivalentni, zato se ju ne sme prosto zamenjevati (glejte poglavje 5.2).
English: In HCC patients with compromised livers, these non-hepatic effects may be precipitating factors for the development of hepatic encephalopathy.
Slovenian: Pri bolnikih s HCK s kompromitiranimi jetri so ti ne-jetrni učinki lahko sprožilni dejavnik za razvoj jetrne encefalopatije.
English: Juvenile rats (correlating to a <2- year paediatric population) showed similar treatment-related findings but appeared to be more sensitive to cabozantinib-related toxicity at comparable dose levels.
Slovenian: Ocenitve mladih podgan (primerljivo z < 2-letno pediatrično populacijo) so pokazale podobne izsledke za zdravljenje, vendar kaže, da je občutljivost za toksičnost zaradi kabozantiniba pri primerljivih ravneh odmerkov večja.
English: Cabozantinib was not carcinogenic in the rasH2 mouse model at a slightly higher exposure than the intended human therapeutic exposure.
Slovenian: Kabozantinib v mišjem modelu rasH2 ni bil kancerogen pri nekoliko večji izpostavljenosti od nameravane terapevtske izpostavljenosti ljudi.
English: This may be due to liver problems.
Slovenian: To bi lahko bile posledice težav z jetri.
English: Cabozantinib has minor influence on the ability to drive and use machines.
Slovenian: Kabozantinib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Interrupt treatment until the adverse reaction resolves to Grade ≤1.
Slovenian: Zdravljenje prekinite, dokler neželeni učinki ne izzvenijo do ≤ 1. stopnje.
English: Events were Grade 4 and 5.
Slovenian: Dogodki so bili 4. in 5. stopnje.
English: The Kaplan- Meier estimates for median duration of OS were 11.1 months in the cabozantinib arm versus 6.9 months in the placebo arm, an estimated 4.2-month difference in the medians.
Slovenian: Kaplan-Meierjevi oceni mediane trajanja celokupnega preživetja (OS) sta znašali 11,1 meseca v skupini s kabozantinibom v primerjavi s 6,9 meseca v skupini s placebom, z ocenjeno razliko mediane 4,2 meseca.
English: Objective Response Rate n (%)3
Slovenian: Delež objektivnega odziva n (%)3
English: Prompt medical management, including supportive care with antiemetics, antidiarrhoeals, or antacids, should be instituted to prevent dehydration, electrolyte imbalances and weight loss.
Slovenian: Nemudoma je treba uvesti ustrezne medicinske ukrepe, vključno s podpornim zdravljenjem z antiemetiki, antidiaroiki ali antacidi, da se prepreči dehidracija, neravnovesje elektrolitov in izguba telesne mase.
English: In vitro data demonstrate that cabozantinib is a substrate of MRP2.
Slovenian: Podatki in vitro kažejo, da je kabozantinib substrat za MRP2.
English: PVC/PCTFE blister with push-through aluminum foil backing containing 7 film-coated tablets.
Slovenian: Pretisni omot PVC/PCTFE z aluminijasto folijo, skozi katero se potisne tableta; vsebuje 7 filmsko obloženih tablet.
English: Progression-free survival (PFS) was assessed by a blinded independent radiology review committee, and the primary analysis was conducted among the first 375 subjects randomized.
Slovenian: Preživetje brez napredovanja (PFS, progression-free survival) je slepo ocenila neodvisna radiološka komisija, primarno analizo pa so izvedli pri prvih 375 randomiziranih osebah.
English: No case of RPLS was reported in the METEOR or CABOSUN or CELESTIAL studies, but RPLS has been reported rarely in other clinical studies (in 2/4872 subjects; 0.04%).
Slovenian: V študijah METEOR, CABOSUN ali CELESTIAL niso poročali o nobenem primeru RPLS, so pa o redkih primerih RPLS poročali v drugih kliničnih študijah (pri 2/4.872 oseb; 0,04 %).
English: Findings in uterus/ovaries and decreased haematopoiesis appeared to be transient, while effects on bone parameters and liver pigmentation were sustained.
Slovenian: Kaže, da so izsledki v maternici/jajčnikih in zmanjšana hematopoeza prehodni, medtem ko so učinki na kostne parametre in pigmentacijo jeter trajni.
English: CABOMETYX tablets are available in packs containing either 4 blisters with 7 tablets each (28 total), or one plastic bottle with 30 tablets.
Slovenian: Zdravilo CABOMETYX tablete je na voljo v pakiranjih, ki vsebujejo 4 pretisne omote po 7 tablet (skupaj 28) ali eno plastenko s 30 tabletami.
English: In the case of persistent hypertension despite use of anti-hypertensives, the cabozantinib dose should be reduced.
Slovenian: V primeru trdovratne hipertenzije, kljub uporabi antihipertenzivov, je treba odmerek kabozantiniba zmanjšati.
English: Progressive Disease
Slovenian: Napredujoča bolezen
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.
Slovenian: Če ste vzeli večji odmerek zdravila CABOMETYX, kot bi smeli Če ste vzeli več zdravila CABOMETYX, kot vam je bilo naročeno, se pogovorite z zdravnikom ali pojdite takoj v bolnišnico s tabletami in tem navodilom.
English: Injury, poisoning and procedural complications wound complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih zapleti z ranami
English: ORR per Investigator Review Intent-To-Treat Population
Slovenian: ORR po oceni raziskovalca populacije z namenom zdravljenja
English: Patient distribution by IMDC risk groups was 81% intermediate (1-2 risk factors) and 19% poor (≥3 risk factors).
Slovenian: Porazdelitev bolnikov glede na skupine tveganja po IMDC je bila 81 % za srednje ugoden (1-2 dejavnika tveganja) in 19 % za slab prognostični obet (≥ 3 dejavniki tveganja).
English: A less than 10% difference in the AUC was observed between cabozantinib tablet (CABOMETYX) and capsule (COMETRIQ) formulations.
Slovenian: Manj kot 10-% razliko za AUC so opazili za tablete kabozantiniba (zdravilo CABOMETYX) in kapsule (zdravilo COMETRIQ).
English: What CABOMETYX is and what it is used for
Slovenian: Kaj je zdravilo CABOMETYX in za kaj ga uporabljamo
English: If adverse reaction resolves to Grade ≤1, re-initiate at a reduced dose.
Slovenian: Če neželeni učinki izzvenijo do ≤ 1. stopnje, ponovno uvedite zdravljenje z zmanjšanim odmerkom.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Slovenian: ŠTEVILKA SERIJE<, ENOTNE OZNAKE DAROVANJA IN IZDELKOV> Lot
English: Most patients (87%) had ECOG performance status of 0 or 1; 13% had an ECOG performance status of 2.
Slovenian: Večina bolnikov (87 %) je imela oceno stanja telesne zmogljivosti po lestvici ECOG 0 ali 1; 13 % bolnikov je imelo oceno stanja telesne zmogljivosti po lestvici ECOG 2.
English: The study was not powered for the OS analysis and the data are immature.
Slovenian: Študija ni imela moči za analizo celokupnega preživetja, podatki pa niso bili zreli.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinske kinaze, oznaka ATC: L01XE26
English: • Blood clots in the veins, arteries and lungs
Slovenian: • krvni strdki v venah, arterijah in pljučih
English: In addition, cabozantinib inhibits other tyrosine kinases including the GAS6 receptor (AXL), RET, ROS1, TYRO3, MER, the stem cell factor receptor (KIT), TRKB, Fms-like tyrosine kinase-3 (FLT3), and TIE-2.
Slovenian: Poleg tega kabozantinib zavira druge tirozin-kinaze, vključno z receptorjem GAS6 (AXL), RET, ROS1, TYRO3, MER, receptorjem faktorja matičnih celic (KIT), TRKB, Fms-ju podobno tirozin-kinazo-3 (FLT3) in TIE-2.
English: Therefore, caution should be recommended when driving or operating machines.
Slovenian: Zato je potrebna pri vožnji ali upravljanju strojev previdnost.
English: Patients were stratified by IMDC risk group and presence of bone metastases (yes/no).
Slovenian: Bolniki so bili stratificirani glede na skupino tveganja po IMDC in glede na prisotnost zasevkov v kosteh (da/ne).
English: CABOMETYX treatment was associated with a trend for longer survival compared to sunitinib (Table 5).
Slovenian: Zdravljenje z zdravilom CABOMETYX je bilo povezano s trendom k daljšemu preživetju v primerjavi z zdravljenjem s sunitinibom (preglednica 5).
English: The CELESTIAL study excluded patients with concomitant anticoagulation treatment or antiplatelet agents.
Slovenian: Iz študije CELESTIAL so bili izključeni bolniki, ki so se sočasno zdravili z antikoagulanti ali antitrombotičnimi zdravili.
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.
Slovenian: Kabozantinib je treba uporabljati previdno pri bolnikih s podaljšanjem intervala QT v anamnezi, pri bolnikih, ki jemljejo antiaritmike, in pri bolnikih z relevantno obstoječo boleznijo srca, bradikardijo ali elektrolitskimi motnjami.
English: Adverse reactions are listed in Table 2 according to MedDRA System Organ Class and frequency categories.
Slovenian: Neželeni učinki v preglednici 2 so razvrščeni po dogovoru MedDRA po organskih sistemih in pogostnosti.
English: Patients with treated brain metastases were allowed.
Slovenian: Bolniki z zdravljenimi metastazami v možganih so bili vključeni.
English: Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking CABOMETYX.
Slovenian: Bolnikom je treba naročiti, naj vsaj 2 uri pred uporabo zdravila CABOMETYX in 1 uro po tem ničesar ne jedo.
English: Therapy with CABOMETYX should be initiated by a physician experienced in the administration of anticancer medicinal products.
Slovenian: Zdravljenje z zdravilom CABOMETYX mora uvesti zdravnik z izkušnjami v uporabi zdravil za zdravljenje raka.
English: The usual dose is 60 mg, however your doctor will decide on the right dose for you.
Slovenian: Zdravilo CABOMETYX jemljite enkrat na dan. Običajni odmerek je 60 mg, vendar bo vaš zdravnik določil odmerek, ki je za vas pravi.
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.
Slovenian: V študiji pri osebah z okvaro ledvic, izvedeni z enkratnim 60-mg odmerkom kabozantiniba, so razmerja geometričnega povprečja LS za kabozantinib v plazmi, Cmax in AUC0-inf za 19 % oz. 30 % višja za osebe z blago okvaro ledvic (90-% IZ za Cmax 91,60 % do 155,51 %; AUC0-inf 98,79 % do 171,26 %) ter za 2 % oz. 6 do 7 % višja (90-% IZ za Cmax 78,64 % do 133,52 %; AUC0-inf 79,61 % do 140,11 %) za osebe z zmerno okvaro ledvic v primerjavi z osebami z normalnim delovanjem ledvic.
English: If a patient must switch from cabozantinib capsules to cabozantinib tablets, the patient should continue at a CABOMETYX dose not to exceed 60 mg or the current COMETRIQ dose (whichever is lower).
Slovenian: Če mora bolnik preiti z zdravljenja s kapsulami kabozantiniba na tablete kabozantiniba, mora nadaljevati z odmerkom zdravila CABOMETYX do 60 mg ali s trenutnim odmerkom zdravila COMETRIQ (kar je nižje).
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.
Slovenian: Pojavnost sistemskega ne-radiacijskega zdravljenja in lokalno v jetra usmerjenega sistemskega protitumorskega zdravljena, ki ni bil predviden po protokolu (NPACT; non-protocol anticancer therapy) je v skupini s kabozantinibom znašala 26 %, v skupini s placebom pa 33 %.
English: Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Slovenian: Po uporabi kažejo profili plazemske koncentracije kabozantiniba glede na čas drugi vrh absorpcije približno 24 ur po dajanju, kar kaže, da je lahko kabozantinib predmet enterohepatične recirkulacije.
English: Aetiology for HCC included 38% hepatitis B virus (HBV), 21% hepatitis C virus (HCV), 40% other (neither HBV nor HCV).
Slovenian: Etiologija HCK: pri 38 % bolnikov virus hepatitisa B (HBV), pri 21 % bolnikov virus hepatitisa C (HCV) in pri 40 % bolnikov drugi vzroki (niti HBV niti HCV).
English: It is recommended to monitor biochemical parameters during cabozantinib treatment and to institute appropriate replacement therapy according to standard clinical practice if required.
Slovenian: Med zdravljenjem s kabozantinibom je priporočljivo spremljati biokemijske parametre in po potrebi uvesti ustrezno nadomestno zdravljenje v skladu s standardno klinično prakso.
English: Persistent or recurring diarrhoea while on treatment may be a risk factor for the development of anal fistula.
Slovenian: Trajna ali ponavljajoča se driska med zdravljenjem je lahko dejavnik tveganja za nastanek analne fistule.
English: If adverse reaction does not resolve, permanently discontinue CABOMETYX.
Slovenian: Če neželeni učinki ne izzvenijo, trajno prenehajte z uporabo zdravila CABOMETYX.
English: Subjects with untreated, or incompletely treated, varices with bleeding or high risk for bleeding were also excluded from this study.
Slovenian: Iz študije so izključili tudi osebe z nezdravljenimi ali nepopolno zdravljenimi varicami, ki so krvavele, ali pa je obstajalo visoko tveganje, da zakrvavijo.
English: • Decrease in levels of; calcium, sodium and phosphate in the blood
Slovenian: • znižanje ravni kalcija, natrija in fosfatov v krvi
English: Comparable results for OS were observed with a follow-up analysis (descriptive) at 430 events.
Slovenian: Pri nadaljnji analizi (opisni) so bili rezultati za OS pri 430 dogodkih primerljivi.
English: The baseline demographic and disease characteristics were similar between the CABOMETYX and placebo arms and are shown below for all 707 randomised patients:
Slovenian: Izhodiščne demografske značilnosti in lastnosti bolezni so bile med skupino z zdravilom CABOMETYX in skupino s placebom podobne in so v nadaljevanju prikazane za vseh 707 randomiziranih bolnikov:
English: HR (95% CI); stratified b,c
Slovenian: HR (95-% IZ); stratificiranib,c
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.
Slovenian: Kabozantinib je majhna molekula, ki zavira več receptorskih tirozin-kinaz (RTK), vpletenih v rast tumorja in angiogenezo, patološko preoblikovanje kosti, odpornost na zdravilo in metastatsko napredovanje raka.
English: CABOMETYX blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Slovenian: Zdravilo CABOMETYX zavre delovanje beljakovin, imenovanih receptorji tirozin kinaze (RTK), ki sodelujejo pri rasti celic in razvoju novih krvnih žil, ki jih oskrbujejo.
English: Tumour assessments were conducted every 8 weeks.
Slovenian: Vrednotenje tumorja je bilo izvedeno vsakih 8 tednov.
English: Each film-coated tablet contains 31.07 mg lactose.
Slovenian: Ena filmsko obložena tableta vsebuje 31,07 mg laktoze.
English: You may need treatment for them, or your doctor may decide to change your dose of CABOMETYX, or stop treatment altogether.
Slovenian: Morda vas bo treba zdraviti ali pa se bo zdravnik odločil, da odmerek zdravila CABOMETYX spremeni ali zdravljenje ukine.
English: Other medicines and CABOMETYX
Slovenian: Druga zdravila in zdravilo CABOMETYX
English: Mean clearance (CL/F) at steady-state was estimated to be 2.48 L/hr .
Slovenian: Povprečni očistek (CL/F) v stanju dinamičnega ravnovesja je bil ocenjen na 2,48 l/uro.
English: The majority of the patients were male (78%) with a median age of 62 years.
Slovenian: Večina bolnikov je bila moškega spola (78 %) z mediano starosti 62 let.
English: According to the Memorial Sloan Kettering Cancer Center criteria for prognostic risk category, 46% were favorable (0 risk factors), 42% were intermediate (1 risk factor), and 13% were poor (2 or 3 risk factors).
Slovenian: Po kriterijih Centra za zdravljenje raka Memorial Sloan (Memorial Sloan Kettering Cancer Center) za prognostično kategorijo obetov je bilo 46 % z ugodnim (0 dejavnikov tveganja), 42 % s srednje ugodnim (1 dejavnik tveganja) in 13 % s slabim obetom (2 ali 3 dejavniki tveganja).
English: All events were Grade 3 or 4.
Slovenian: Vsi dogodki so bili 3. ali 4. stopnje.
English: Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Slovenian: Z uporabo kabozantiniba je treba prenehati, če je hipertenzija resna ali trdovratna kljub zdravljenju z antihipertenzivi in zmanjšanju odmerka kabozantiniba.
English: Secondary efficacy endpoints were objective response rate (ORR) and overall survival (OS).
Slovenian: Sekundarna opazovana dogodka učinkovitosti sta bila stopnja objektivnega odziva (ORR) in celokupno preživetje (OS).
English: This could mean that your doctor needs to change the dose(s) that you take.
Slovenian: To pomeni, da bo morda zdravnik moral prilagoditi odmerek/odmerke, ki ga/jih jemljete.
English: • Low level of albumin in blood
Slovenian: • nizka raven albumina v krvi
English: Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible.
Slovenian: Zaradi visoke stopnje vezave kabozantiniba na plazemske beljakovine (glejte poglavje 5.2) je možna interakcija z varfarinom v obliki izpodrivanja s plazemskih beljakovin.
English: • Alopecia (hair loss and thinning), hair colour change
Slovenian: • alopecija (izpadanje ali redčenje las in dlak), sprememba barve las oziroma dlak
English: Two non-conjugated metabolites (XL184N-oxide and XL184 amide cleavage product), which possess <1% of the on-target kinase inhibition potency of parent cabozantinib, each represent <10% of total drug-related plasma exposure.
Slovenian: Dva nekonjugirana presnovka (XL184-N-oksid in produkt cepitve XL184 amida), ki imata < 1 % ciljne zaviralne učinkovitosti kinaze izhodiščnega kabozantiniba, vsak predstavljata < 10 % skupne z zdravilom povezane izpostavljenosti v plazmi.
English: Effect of cabozantinib on other medicinal products The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
Slovenian: Učinka kabozantiniba na farmakokinetiko kontraceptivnih steroidov niso preučili.
English: During treatment with cabozantinib, all patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Slovenian: Med zdravljenjem s kabozantinibom je treba vse bolnike spremljati za pojav hipertenzije in jih po potrebi zdraviti s standardnimi antihipertenzivi.
English: Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCE
Slovenian: Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCIJA
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).
Slovenian: Načrtovana vmesna analiza OS je bila opravljena v času analize PFS in ni dosegla vmesne meje za statistično značilnost (202 dogodka, HR = 0,68 [0,51; 0,90], p = 0,006).
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).
Slovenian: Uporablja se za zdravljenje: - napredovalih stopenj raka ledvic, imenovanega karcinom ledvičnih celic, - raka jeter pri odraslih, ki so se predhodno že zdravili s specifičnim zdravilom za zdravljenje raka (sorafenib).
English: The majority of the patients were male (75%), with a median age of 62 years.
Slovenian: Večina bolnikov je bila moških (75 %) z mediano starosti 62 let.
English: Film-coating Hypromellose 2910 Titanium dioxide (E171) Triacetin
Slovenian: Filmska obloga hipromeloza 2910 titanov dioksid (E171) triacetin rumeni železov oksid (E172)
English: Also, some medicines can affect the way CABOMETYX works.
Slovenian: Prav tako lahko nekatera druga zdravila vplivajo na delovanje zdravila CABOMETYX.
English: Each film-coated tablet contains 15.54 mg lactose.
Slovenian: Ena filmsko obložena tableta vsebuje 15,54 mg laktoze.
English: Do not use this medicine after the expiry date which is stated on the blister, bottle label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu, na nalepki plastenke in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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.
Slovenian: Pri bolnikih z obema, pozitivnim in negativnim statusom MET, so ugotovili koristen učinek zdravila CABOMETYX v primerjavi s sunitinibom, z večjo aktivnostjo pri bolnikih s pozitivnim statusom MET v primerjavi z bolniki z negativnim statusom MET (HR = 0,32 (0,16; 0,63) v primerjavi z 0,67 (0,37; 1,23)).