natgillin/translations-raw huggingface dataset:
• A tear or abnormal connection of the tissue in your digestive system; symptoms can include severe or persistent stomach ache
• raztrganje ali nenormalne povezave tkiva v prebavilih; simptomi lahko vključujejo hude ali trdovratne bolečine v trebuhu
The objective response rates measured in these subgroups were generally consistent with the PFS results, with the RET mutation positive, negative, and unknown subgroups showing tumour response rates of 32%, 22%, and 25%, respectively.
Objektivne stopnje odzivov, izmerjene v teh podskupinah, so bile na splošno konsistentne z rezultati PFS, pri čemer so bile stopnje odziva v podskupini s pozitivno mutacijo RET 32 %, v podskupini z negativno mutacijo RET 22 % in v podskupini z neznano mutacijo RET 25 %.
What you need to know before you take COMETRIQ 3.
Kaj morate vedeti, preden boste vzeli zdravilo COMETRIQ 3.
Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking COMETRIQ.
Bolnikom je treba naročiti, naj vsaj 2 uri pred uporabo zdravila COMETRIQ in 1 uro po tem ničesar ne jedo.
Avoid consuming grapefruit-containing products for as long as you are using this medicine, as it may increase the levels of COMETRIQ in your blood.
Dokler uporabljate zdravilo COMETRIQ, ne jejte živil, ki vsebujejo grenivko, saj lahko zviša ravni zdravila v krvi.
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.
Ponavljajoče se dnevno odmerjanje kabozantiniba v odmerku 140 mg za 19 dni je povzročilo približno 4- do 5-kratno povprečno kopičenje kabozantiniba (na podlagi AUC) v primerjavi z uporabo enega odmerka; stanje dinamičnega ravnovesja se doseže na približno 15. dan.
RPLS is uncommon (it affects less than 1 in 100 people).
RPLS je občasen neželeni učinek (prizadene manj kot 1 od 100 bolnikov).
Cabozantinib should be discontinued if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of cabozantinib.
Z uporabo kabozantiniba je treba prenehati, če je hipertenzija resna ali trdovratna kljub zdravljenju z antihipertenzivi in zmanjšanjem odmerka kabozantiniba.
A dose-comparison study (XL-184-401) (140 mg vs 60 mg) in 112 patients with hereditary or sporadic medullary thyroid cancer.
Študija primerjave odmerka (XL-184-401) (140 mg v primerjavi s 60 mg) pri 112 bolnikih z dednim ali sporadičnim medularnim rakom ščitnice.
Cabozantinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with cabozantinib.
Kabozantiniba ne smete uporabljati med nosečnostjo, razen če zdravljenje s kabozantinibom ni nujno potrebno zaradi kliničnega stanja ženske.
Monitor for adverse events and adjust dose or use dosing interruption as needed (see section 4.2).
Spremljati je treba neželene učinke in odmerek po potrebi prilagajati ali dajanje prekiniti (glejte poglavje 4.2).
Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities.
Prekinitev odmerka se priporoča pri obravnavi toksičnosti 3. ali višje stopnje po CTCAE (common terminology criteria for adverse events) ali nevzdržnih toksičnosti 2. stopnje.
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
Your capsules are also available as a 28 day pack, which contains enough capsules to last for 28 days, in 4 blister cards with seven days of capsules on each card.
Kapsule so na voljo kot 28-dnevno pakiranje, ki vsebuje dovolj kapsul za 28 dni v 4 pretisnih zgibankah s kapsulami za sedem dni na vsaki zgibanki.
Fresh tumour samples for tumour genetic analysis from the most recent metastatic site in patients enrolled in the dose-comparison study should be collected.
Odvzeti je treba sveže vzorce tumorjev za gensko analizo tumorjev na nazadnje nastalih mestih zasevkov pri bolnikih, vključenih v študijo primerjave odmerka.
Centralized, independent, blinded review of the imaging data was used in the assessment of PFS and ORR.
Pri oceni PFS in ORR so opravili centralizirane, neodvisne, slepe preglede slikovnih podatkov.
Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible.
Zaradi visoke stopnje vezave kabozantiniba na plazemske beljakovine (glejte poglavje 5.2), lahko pride do interakcije izpodrivanja plazemskih beljakovin z varfarinom.
The PFS results were consistent across all baseline and demographic subgroups evaluated, including prior therapy with tyrosine kinase inhibitors (which may have consisted of agents targeting pathways associated with anti-angiogenesis), RET mutational status (including subjects documented not to have RET mutations), prior anticancer or radiotherapy status, or the existence of bone metastases.
Rezultati PFS so bili konsistentni za vsa izhodišča in ocenjene demografske podskupine, vključno s predhodnim zdravljenjem z zaviralci tirozin-kinaze (ki je lahko zajemalo učinkovine, ki so ciljale na poti, povezane z anti-angiogenezo), statusom mutacije RET (vključno z osebami, za katere je bilo dokumentirano, da nimajo mutacij RET), predhodnim statusom zdravljenja raka ali obsevanja ali obstojem kostnih metastaz.
The capsule contains an off-white to white powder.
Kapsula vsebuje belkast do bel prašek.
Your capsules will come in a blister card organised by prescribed dose.
Kapsule so pakirane v pretisne zgibanke, organizirane glede na predpisani odmerek.
26.6 months
26,6 mesecev
11.2 months
11,2 meseca
Cabozantinib is a substrate for CYP3A4 metabolism in vitro, as a neutralizing antibody to CYP3A4 inhibited formation of metabolite XL184 N-oxide by >80% in a NADPH-catalyzed human liver microsomal (HLM) incubation; in contrast, neutralizing antibodies to CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 and CYP2E1 had no effect on cabozantinib metabolite formation.
Kabozantinib je in vitro substrat presnove CYP3A4, kot nevtralizirajoče protitelo za nastanek presnovka XL184 N-oksida, ki ga zavre CYP3A4 za > 80 %, v inkubaciji mikrosomov človeških jeter, kataliziranega z NADPH; nasprotno pa nevtralizirajoča protitelesa za CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 in CYP2E1 niso vplivala na nastanek presnovka kabozantiniba.
Adverse reactions are listed in Table 1 according to MedDRA system organ class and frequency categories.
Neželeni učinki v preglednici 1 so razvrščeni po dogovoru MedDRA po organskih sistemih in pogostnosti.
COMETRIQ capsules are packaged in blister cards organised by prescribed dose.
COMETRIQ kapsule so pakirane v pretisne zgibanke, urejene glede na predpisani odmerek.
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.
V 48-dnevnem obdobju zbiranja po enem odmerku 14C-kabozantiniba pri zdravih prostovoljcih se je približno 81 % skupne uporabljene radioaktivnosti izločilo z blatom (54 %) in urinom (27 %).
Clinical data in medullary thyroid cancer
Klinični podatki pri medularnem raku ščitnice
Patients with severe renal impairment have not been studied.
Bolnikov s hudo okvaro ledvic niso preučevali.
• Blood clots in the arteries
• krvni strdki v arterijah
COMETRIQ is a medicine used to treat medullary thyroid cancer, a rare type of thyroid cancer, that cannot be removed by surgery or that has spread to other parts of the body.
Kaj je zdravilo COMETRIQ in za kaj ga uporabljamo Zdravilo COMETRIQ se uporablja za zdravljenje medularnega raka ščitnice, ki je redka vrsta raka ščitnice in se ga ne da kirurško odstraniti ali pa se je razširil na druge dele telesa.
Urine protein should be monitored regularly during cabozantinib treatment.
V času zdravljenja s kabozantinibom je treba redno spremljati beljakovine v urinu.
OTHER SPECIAL WARNING(S), IF NECESSARY Refer to individual blister cards for dispensing instructions.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Za navodila glede dajanja glejte posamezne pretisne zgibanke.
Following oral administration of cabozantinib, peak cabozantinib plasma concentrations are reached at 2 to 5 hours post-dose.
Po peroralni uporabi kabozantiniba so najvišje koncentracije kabozantiniba v plazmi dosežene 2 do 5 ur po odmerku.
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.
V plazmi so bili prisotni štirje presnovki z izpostavljenostmi (AUC), večjimi kot 10 % izhodiščne spojine: XL184-N-oksid, produkt cepitve XL184 amida, XL184 monohidroksi sulfat in produkt cepitve 6-desmetil amida sulfat.
Of the 215 subjects with sufficient data to determine mutational status, 78.6% (n=169) were classified as RET mutation positive (126 of which were positive for the M918T mutation), and 21.4% (n=46) were classified as RET mutation negative.
Med 215 osebami, pri katerih so podatki zadoščali za določitev statusa mutacije, jih je bilo 78,6 % (n = 169) razvrščenih kot pozitivnih za mutacijo RET (126 med njimi je bilo pozitivnih za mutacijo M918T) in 21,4 % (n = 46) je bilo razvrščenih kot negativnih za mutacijo RET. Za dodatnih 115 oseb statusa mutacije RET ni bilo mogoče določiti ali ni bil jasen.
Cabozantinib treatment should be stopped at least 28 days prior to scheduled surgery, if possible.
Zdravljenje s kabozantinibom je treba ustaviti vsaj 28 dni pred načrtovanim operativnim posegom, če je mogoče.
You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking COMETRIQ and for at least 4 months after treatment has finished.
Zato morate med jemanjem zdravila COMETRIQ in še vsaj 4 mesece po koncu zdravljenja uporabljati tudi pregradno kontracepcijsko metodo (npr. kondom ali diafragmo).
The active substance is cabozantinib (S)-malate.
Zdravilna učinkovina je kabozantinib (S)-malat.
Black iron oxide (E172) (20 mg capsules only) Red iron oxide (E172) (80 mg capsules only) Titanium dioxide (E171)
Ovojnica kapsule želatina črni železov oksid (E172) (samo 20 mg kapsule) rdeči železov oksid (E172) (samo 80 mg kapsule) titanov dioksid (E171)
Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
Kabozantinib je treba ukiniti pri bolnikih z zapleti s celjenjem rane, zaradi katerih je potrebna zdravniška pomoč.
When using cabozantinib, periodic monitoring with on-treatment ECGs and electrolytes (serum calcium, potassium, and magnesium) should be considered.
Pri uporabi kabozantiniba je treba razmisliti o periodičnem spremljanju EKG in elektrolitov (kalcij, kalij in magnezij v serumu) med zdravljenjem.
NOAEL for embryo-foetal toxicity and teratogenic findings were below human clinical exposure levels at intended therapeutic dose.
NOAEL za toksičnost embria-zarodka in izsledki o teratogenosti so bili pod ravnmi klinične izpostavljenosti pri ljudeh pri nameravanih terapevtskih odmerkih.
• Lightening of skin, flakey skin, unusual pale skin
• posvetlitev kože, luščenje kože, neobičajno bleda koža
PVC/PE/PCTFE-Al blisters with foil backing, sealed into a secondary heat-sealed card packaging.
Pretisni omot iz PVC/PE/PCTFE-aluminija s prekrivno folijo, toplotno zavarjen v sekundarno, ovojnino, v obliki zgibanke.
Efficacy with cabozantinib was observed in medullary thyroid cancer patients with wild-type or mutant RET.
Učinkovitost s kabozantinibom so opazili pri bolnikih z medularnim rakom ščitnice z nemutiranim ali mutiranim RET.
When PPES is severe, interruption of treatment with cabozantinib should be considered.
Pri resni PPES je treba razmisliti o prekinitvi zdravljenja s kabozantinibom.
BATCH NUMBER<, DONATION AND PRODUCT CODES> Lot
ŠTEVILKA SERIJE <, ENOTNE OZNAKE DAROVANJA IN IZDELKOV> Serija
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).
Pri sočasni uporabi z drugimi zdravili, ki so močni zaviralci CYP3A4, je potrebna previdnost, kronični uporabi z zdravili, ki so močni induktorji CYP3A4, pa se je treba izogniti (glejte poglavji 4.4 in 4.5).
Psychiatric disorders anxiety, depression, confusional state abnormal dreams, delirium
Psihiatrične motnje anksioznost, depresija, stanje zmedenosti nenormalne sanje, delirij
The ORR was 27.9% and 0% for subjects in the cabozantinib arm and placebo arm, respectively (p<0.0001; Table 2).
ORR je bil 27,9 % za osebe v skupini s kabozantinibom in 0 % za osebe v skupini s placebom (p < 0,0001; preglednica 2).
Protein binding was not altered in subjects with mild or moderately impaired renal or hepatic function.
Vezava na beljakovine ni bila spremenjena pri osebah z blago ali zmerno okvarjenim delovanjem ledvic ali jeter.
• Blood clots in the veins and the lungs
• krvni strdki v žilah in pljučih
There is limited data in patients with cardiac impairment.
Bolniki s srčno okvaro Podatki pri bolnikih s srčno okvaro je malo.
Do not use this medicine after the expiry date which is stated on the blister card after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisni zgibanki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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.
Pri uporabi kabozantiniba pri bolnikih s podaljšanjem intervala QT v anamnezi, pri bolnikih, ki jemljejo antiaritmike ali pri bolnikih z relevantno obstoječo boleznijo srca, bradikardijo ali motnjo elektrolitov, je potrebna previdnost.
Depending on the dose you were prescribed, the number of capsules to take are as follows:
Število kapsul, ki jih morate vzeti, je odvisno od odmerka, ki vam je bil predpisan, in je lahko:
Patients with severe hepatic impairment have not been studied.
Bolnikov s hudo okvaro jeter niso preučevali.
In rabbits, cabozantinib produced foetal soft tissue changes (reduced spleen size, small or missing intermediate lung lobe) and increased foetal incidence of total malformations.
Pri kuncih je kabozantinib povzročil spremembe mehkega tkiva pri plodu (zmanjšano velikost vranice, majhen ali manjkajoč vmesni pljučni lobus) in večjo incidenco skupnih malformacij pri plodu.
• Stopping menstruation, vaginal bleeding
• prenehanje menstruacij, krvavitve iz nožnice
Patients who have evidence of involvement of the trachea or bronchi by tumour or a history of haemoptysis prior to treatment initiation should be carefully evaluated before initiating cabozantinib therapy.
Bolnike, ki imajo znake vpletenosti požiralnika ali sapnic v tumor ali hemoptizo v anamnezi, je treba pred uvedbo zdravljenja s kabozantinibom skrbno oceniti.
Median Progression-Free Survival
Mediano preživetje brez napredovanja bolezni
If you get side effects, your doctor may tell you to take COMETRIQ at a lower dose.
Če boste dobili neželene učinke, vam bo zdravnik morda naročil, da jemljete manjše odmerke zdravila COMETRIQ.
If your next dose is due in less than 12 hours then do not take the dose that you have missed.
Če je do naslednjega odmerka manj kot 12 ur, ne vzemite izpuščenega odmerka.
It is important for you to practice good mouth care during treatment with COMETRIQ.
Pomembno je, da med zdravljenjem z zdravilom COMETRIQ vzdržujete dobro ustno higieno.
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA peroralna uporaba.
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.
V študijah toksičnosti pri ponavljajočih se odmerkih pri podganah in psih, ki so trajale do 6 mesecev, so bili ciljni organi za toksičnost prebavila, kostni mozeg, limfoidno tkivo, ledvice, tkivo nadledvične žleze in rodil.
• Pain in the arms, hands, legs or feet
• bolečine v rokah, dlaneh, nogah ali stopalih
• Inflammation at the root of your hair, acne, blisters (on parts of your body other than the hands or feet)
• vnetje lasne korenine, akne, mehurji (na delih telesa, razen dlaneh in stopalih)
You should not take COMETRIQ with food.
Zdravila COMETRIQ ne smete jemati s hrano.
What you need to know before you take COMETRIQ
Kaj morate vedeti, preden boste vzeli zdravilo COMETRIQ
• Chest pain due to blockage in arteries, rapid heartbeat
• bolečina v prsih zaradi blokade arterij, hiter srčni utrip
Cabozantinib should be discontinued in patients who develop an acute myocardial infarction or any other clinically significant arterial thromboembolic complication.
Z uporabo kabozantiniba je treba prenehati pri bolnikih, pri katerih se razvije akutni miokardni infarkt ali drugi klinično pomembni zapleti arterijske trombembolije.
• Hair colour changes (lightening), hair loss
• spremenjena barva last (posvetlitev), izpadanje las
How to take COMETRIQ 4.
Kako jemati zdravilo COMETRIQ 4.
Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-glycoprotein (P-gp) transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Kabozantinib je bil zaviralec (IC50 = 7,0 μM), ne pa tudi substrat prenašalskih aktivnosti Pglikoproteina (P-gp) v sistemu dvosmernega testa z uporabo celic MDCK-MDR1.
three grey 20 mg
tri sive 20 mg
A thyroid stimulating hormone (TSH) value above normal after first dose was observed in 57% of patients on cabozantinib versus 19% of patients on placebo (regardless of baseline values).
Pri 57 % bolnikov, ki so uporabljali kabozantinib, so po prvem odmerku opazili vrednosti tiroideo stimulirajočega hormona (TSH) nad normalnimi v primerjavi z 19 % bolniki, ki so dobivali placebo (neodvisno od vrednosti ob izhodišču).
The no observed adverse effect level (NOAEL) for these findings were below human clinical exposure levels at intended therapeutic dose.
Raven brez opaženega neželenega učinka (NOAEL, no observed adverse effect level) za te izsledke je bila pod ravnmi klinične izpostavljenosti pri nameravanih terapevtskih odmerkih pri ljudeh.
Therefore, concomitant use of MRP2 inhibitors (e.g. cyclosporine, efavirenz, emtricitabine) should be approached with caution.
Zato je potrebna pri sočasni uporabi zaviralcev MRP2 (npr. ciklosporina, efavirenza, emtricitabina) previdnost.
Cabozantinib should not be administered to patients with serious haemorrhage or recent haemoptysis.
Kabozantiniba se ne sme dajati bolnikom s hudo krvavitvijo ali nedavno hemoptizo.
Each blister card contains enough medicine for 7 days.
Ena pretisna zgibanka vsebuje dovolj zdravila za 7 dni.
Blister cards containing:
Pretisna zgibanka, ki vsebuje:
Talk to your doctor BEFORE taking COMETRIQ if you or your partner are considering or planning to have a baby after your treatment has finished.
PRED uporabo zdravila COMETRIQ se posvetujte z zdravnikom, če vi ali vaša partnerica po koncu zdravljenja razmišljate o zanositvi ali jo načrtujete.
Women of childbearing potential/Contraception in males and females Women of childbearing potential must be advised to avoid pregnancy while on cabozantinib.
Ženske v rodni dobi / kontracepcija pri moških in ženskah Ženskam v rodni dobi je treba svetovati, da v času zdravljenja s kabozantinibom ne smejo zanositi.
The final analysis of OS was conducted after 218 events (deaths) occurred and shows a trend for an increase in median survival of 5.5 months in the cabozantinib arm: median (months) 26.6 cabozantinib vs. 21.1 placebo (HR = 0.85 [95% CI: 0.64, 1.12], p = 0.2409).
Končna analiza OS je bila izvedena po 218 dogodkih (smrtih) in kaže trend za povečanje medianega preživetja za 5,5 meseca v kraku s kabozantinibom: mediana (meseci) 26,6 kabozantinib v primerjavi z 21,1 za placebo (HR = 0,85 [95-% IZ: 0,64; 1,12], p = 0,2409).
Endocrine disorders hypothyroidism
Bolezni endokrinega sistema hipotiroidizem
INFORMATION IN BRAILLE COMETRIQ 20 mg
PODATKI V BRAILLOVI PISAVI COMETRIQ 20 mg
Juvenile rats (comparable to a >2 year old pediatric 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 bile duct hyperplasia.
Pri mladih podganah (primerljivo z > 2-letno pediatrično populacijo), ki so dobivale kabozantinib, so se pokazali zvišani parametri belih krvnih celic, znižana hematopoeza, pubertetni/nezrel ženski reprodukcijski sistem (brez zakasnitve odpiranja nožnice), nenormalnosti zobovja, zmanjšana mineralna vsebnost in gostota kosti, pigmentacija jeter in hiperplazija žolčevoda.
Female partners of male patients taking cabozantinib must also avoid pregnancy.
Zanositev morajo preprečiti tudi ženske partnerice moških bolnikov, ki uporabljajo kabozantinib.
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.
Ocenili so zaviralno aktivnost kabozantinib pri različnih kinazah in ugotovili, da zavira receptorje MET (receptorski protein za hepatocitni rastni faktor) in VEGF (humani vaskularni endotelijski rastni faktor).
Talk to your doctor or pharmacist before taking COMETRIQ if you:
Pred začetkom jemanja zdravila COMETRIQ se posvetujte z zdravnikom ali farmacevtom, če:
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.
Ker lahko kabozantinib škoduje dojenčku, matere med zdravljenjem s kabozantinibom in še 4 mesece po končanju terapije ne smejo dojiti.
In the 2-year rat carcinogenicity study, cabozantinib-related 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.
Neoplastična odkritja 2-letne študije rakotvornosti pri podganah, povezana s kabozantinibom, so izhajala iz povečanega pojava samih benignih feokromocitomov ali v kombinaciji z malignimi feokromocitomi/zapletenimi malignimi feokromocitomi nadledvične sredice pri obeh spolih s precej veliko nižjo izpostavljenostjo, kot je predvidena pri ljudeh.
Dose reductions and dose interruptions occurred in 79% and 72%, respectively, of cabozantinib-treated patients in the pivotal clinical trial.
V osrednjem kliničnem preskušanju so odmerek zmanjšali pri 79 % bolnikov, njegovo dajanje pa so prekinili pri 72 % bolnikov, zdravljenih s kabozantinibom.
All three subgroups showed increased PFS in the cabozantinib arm compared to the placebo arm (HRs of 0.23, 0.53, and 0.30 for RET mutation positive, negative, and unknown subgroups, respectively).
Vse tri podskupine so pokazale povečanje PFS v kraku s kabozantinibom v primerjavi s krakom s placebom (HR 0,23 za podskupino s pozitivno mutacijo RET, 0,53 za podskupino z negativno mutacijo RET in 0,30 RET za podskupino s neznano mutacijo RET).
Based on non-clinical safety findings, male and female fertility may be compromised by treatment with cabozantinib (see section 5.3).
Podatkov o vplivu na plodnost pri ljudeh ni. Na podlagi predkliničnih izsledkov o varnosti lahko zdravljenje s kabozantinibom predstavlja tveganje za plodnost pri moških in ženskah (glejte poglavje 5.3).