FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the short half-life of axitinib, steady state is expected within 2 to 3 days of the initial dose.
Slovenian: Glede na kratek razpolovni čas aksitiniba je vzpostavitev stanja dinamičnega ravnovesja mogoče pričakovati v 2 do 3 dneh po začetnem odmerku.
English: Inlyta film-coated tablets come in different strengths.
Slovenian: Filmsko obložene tablete zdravila Inlyta so na voljo v različnih jakostih.
English: In the overall patient population and the two main subgroups (prior sunitinib treatment and prior cytokine treatment), there was a statistically significant advantage for axitinib over sorafenib for the primary endpoint of PFS (see Table 2 and Figures 1, 2 and 3).
Slovenian: V celokupni populaciji bolnikov in v dveh glavnih podskupinah (predhodno zdravljenje s sunitinibom in predhodno zdravljenje s citokinom) je bil pri primarnem opazovanem dogodku PFS aksitinib statistično pomembno boljši od sorafeniba (glejte Preglednico 2 in Slike 1, 2 in 3).
English: What Inlyta is and what it is used for What you need to know before you take Inlyta How to take Inlyta
Slovenian: Kaj je zdravilo Inlyta in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Inlyta Kako jemati zdravilo Inlyta Možni neželeni učinki
English: If you are breast-feeding, your doctor should discuss with you whether to discontinue breast-feeding or discontinue Inlyta treatment.
Slovenian: Če dojite, se mora zdravnik z vami pogovoriti glede prenehanja dojenja oziroma prenehanja zdravljenja z zdravilom Inlyta.
English: In plasma, the N-glucuronide metabolite represented the predominant radioactive component (50% of circulating radioactivity) and unchanged axitinib and the sulfoxide metabolite each accounted for approximately 20% of the circulating radioactivity.
Slovenian: V plazmi je N-glukuronidni presnovek predstavljal prevladujočo radioaktivno sestavino (50 % radioaktivnosti v obtoku), nespremenjeni aksitinib in sulfoksidni presnovek pa sta vsak predstavljala približno 20 % radioaktivnosti v obtoku.
English: Axitinib should not be used during breast-feeding.
Slovenian: Aksitiniba se v obdobju dojenja ne sme uporabljati.
English: Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy.
Slovenian: Bolnike je treba spremljati glede pojava hipertenzije in po potrebi uporabiti standardno antihipertenzivno zdravljenje.
English: Of the patients enrolled in this study, 389 patients (53.8%) had received one prior sunitinib-based therapy, 251 patients (34.7%) had received one prior cytokine-based therapy (interleukin-2 or interferon-alpha), 59 patients (8.2%) had received one prior bevacizumab-based therapy, and 24 patients (3.3%) had received one prior temsirolimus-based therapy.
Slovenian: Od bolnikov, vključenih v to preskušanje, je 389 bolnikov (53,8 %) prejemalo eno predhodno zdravljenje, temelječe na sunitinibu, 251 bolnikov (34,7 %) je prejemalo eno predhodno zdravljenje, temelječe na citokinu (interlevkin-2 ali interferon-alfa), 59 bolnikov (8,2 %) je prejemalo eno predhodno zdravljenje, temelječe na bevacizumabu, 24 bolnikov (3,3 %) pa je prejemalo eno predhodno zdravljenje, temelječe na temsirolimusu.
English: A fatal acute myocardial infarction and cerebrovascular accident was reported in one patient each (0.3%).
Slovenian: O akutnem miokardnem infarktu ter cerebrovaskularnem insultu s smrtnim izidom so poročali pri enem bolniku za vsak dogodek (0,3 %).
English: Results of this study indicated that axitinib plasma exposures up to two-fold greater than therapeutic levels expected following a 5 mg dose, did not produce clinically-significant QT interval prolongation.
Slovenian: Rezultati tega preskušanja so pokazali, da izpostavljenosti plazemskim koncentracijam aksitiniba, ki so za do dvakrat presegale pričakovane terapevtske koncentracije po 5 mg odmerku, niso povzročile klinično pomembnega podaljšanja intervala QT.
English: Tell your doctor if you have severe abdominal pain while on treatment with this medicine.
Slovenian: Obvestite zdravnika, če imate med zdravljenjem s tem zdravilom hude bolečine v trebuhu.
English: • Protein in the urine (may show in your urine tests)
Slovenian: • beljakovine v urinu (to se lahko pokaže pri preiskavah urina)
English: CYP1A2 and CYP2C19 inhibitors
Slovenian: Zaviralci CYP1A2 in CYP2C19
English: • clarithromycin, erythromycin or telithromycin, antibiotics used to treat bacterial infections;
Slovenian: • klaritromicin, eritromicin ali telitromicin, antibiotiki, ki se uporabljajo za zdravljenje bakterijskih okužb;
English: In a randomised, 2-way crossover study, 35 healthy subjects were administered a single oral dose of axitinib (5 mg) in the absence and presence of 400 mg ketoconazole for 7 days.
Slovenian: V randomiziranem, dvosmernem navzkrižnem preskušanju so 35 zdravim preskušancem dali enkratni peroralni odmerek aksitiniba (5 mg) v odsotnosti in prisotnosti 400 mg ketokonazola v obdobju 7 dni.
English: 56 tablets
Slovenian: 60 tablet
English: Inlyta is a medicine containing the active substance axitinib.
Slovenian: Inlyta je zdravilo, ki vsebuje učinkovino aksitinib.
English: • The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose 2910 (15 mPa·s), titanium dioxide (E171), triacetin (E1518), iron oxide red (E172) (see section 2 Inlyta contains lactose (milk sugar)).
Slovenian: • Druge sestavine zdravila so mikrokristalna celuloza, laktoza monohidrat, premreženi natrijev karmelozat, magnezijev stearat, hipromeloza 2910 (15 mPa·s), titanov dioksid (E171), triacetin (E1518), rdeči železov oksid (E172) (glejte poglavje 2 Zdravilo Inlyta vsebuje laktozo (mlečni sladkor)).
English: However, co-administration of axitinib with paclitaxel, a known CYP2C8 substrate, did not result in increased plasma concentrations of paclitaxel in patients with advanced cancer, indicating lack of clinical CYP2C8 inhibition.
Slovenian: Vendar pa pri sočasni uporabi aksitiniba s paklitakselom, znanim substratom CYP2C8, pri bolnikih z napredovalim rakavim obolenjem ni prišlo do zvečanja plazemskih koncentracij paklitaksela, kar kaže na odsotnost kliničnega zaviranja CYP2C8.
English: Patients (N = 723) with advanced RCC whose disease had progressed on or after treatment with one prior systemic therapy, including sunitinib-, bevacizumab-, temsirolimus-, or cytokinecontaining regimens were randomised (1:1) to receive axitinib (N = 361) or sorafenib (N = 362).
Slovenian: Bolniki (n = 723) z napredovalim RCC, pri katerih je bolezen napredovala med zdravljenjem ali po zdravljenju z eno predhodno sistemsko terapijo (ki je vključevala režime, v katerih so bili uporabljeni sunitinib, bevacizumab, temsirolimus ali citokin), so bili randomizirani (1:1) v skupino, ki je prejemala aksitinib (n = 361) oziroma sorafenib (n = 362).
English: Elevation of haemoglobin or haematocrit
Slovenian: Zvišanje ravni hemoglobina ali hematokrita
English: • An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Slovenian: • razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij)
English: • atazanavir, indinavir, nelfinavir, ritonavir or saquinavir, used to treat HIV infections/AIDS;
Slovenian: • atazanavir, indinavir, nelfinavir, ritonavir ali sakvinavir, ki se uporabljajo za zdravljenje okužb s HIV/AIDS-a;
English: Axitinib-related findings in the testes and epididymis included decreased organ weight, atrophy or degeneration, decreased numbers of germinal cells, hypospermia or abnormal sperm forms, and reduced sperm density and count.
Slovenian: Z aksitinibom povezana opažanja na testisih in epididimisu so vključevala zmanjšano maso organa, atrofijo ali degeneracijo, zmanjšano število germinalnih celic, hipospermijo ali nenormalne oblike semenčic in zmanjšanje gostote ter števila semenčic.
English: Inlyta is not recommended for people aged under 18.
Slovenian: Uporaba zdravila Inlyta pri ljudeh, mlajših od 18 let, ni priporočljiva.
English: You should not take these medicines during your treatment with Inlyta.
Slovenian: Med zdravljenjem z zdravilom Inlyta ne smete jemati teh zdravil.
English: These findings were observed in mice at exposure levels approximately 12-fold the expected human exposure, and in dogs at exposure levels below the expected human exposure.
Slovenian: Te ugotovitve so opažali pri miših, pri stopnjah izpostavljenosti, ki so bile približno 12-krat večje od pričakovane izpostavljenosti pri ljudeh, in pri psih, kjer so bile ravni nižje od pričakovane izpostavljenosti pri ljudeh.
English: • phenytoin, carbamazepine or phenobarbital, anti-epileptics used to stop seizures or fits;
Slovenian: • fenitoin, karbamazepin ali fenobarbital, antiepileptiki, ki se uporabljajo za zaustavitev epileptičnih napadov ali krčev;
English: • If during treatment with this medicine, you get symptoms such as headache, confusion, seizures (fits), or changes in vision with or without high blood pressure.
Slovenian: • Če se vam med zdravljenjem s tem zdravilom pojavijo simptomi, kot so glavobol, zmedenost, epileptični napadi (krči) ali spremembe vida z zvišanim krvnim tlakom ali brez njega.
English: If you accidentally take too many tablets or a higher dose than you need, contact a doctor for advice right away.
Slovenian: Če ste vzeli večji odmerek zdravila Inlyta, kot bi smeli Če ste pomotoma vzeli preveč tablet ali odmerek, ki je večji od potrebnega, se nemudoma posvetujte z zdravnikom.
English: Post-marketing adverse reactions identified in clinical studies are also included.
Slovenian: Vključeni so tudi neželeni učinki, ugotovljeni v kliničnih študijah v obdobju trženja zdravila.
English: Get emergency help right away and call your doctor if you get symptoms such as chest pain or pressure; pain in your arms, back, neck or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; headache; vision changes: or dizziness.
Slovenian: Takoj se obrnite na nujno zdravniško pomoč in pokličite zdravnika, če se vam med zdravljenjem s tem zdravilom pojavijo simptomi, kot so bolečine ali pritisk v prsnem košu; bolečine v rokah, hrbtu, vratu ali čeljusti; kratka sapa; otrplost ali oslabelost na eni strani vašega telesa; težave z govorom; glavobol; spremembe vida ali omotica.
English: The following risks, including appropriate action to be taken, are discussed in greater detail in section 4.4: cardiac failure events, hypertension, thyroid dysfunction, arterial thromboembolic events, venous thromboembolic events, elevation of haemoglobin or haematocrit, haemorrhage, gastrointestinal perforation and fistula formation, wound healing complications, PRES, proteinuria, and elevation of liver enzymes.
Slovenian: Naslednja tveganja, vključno z ustreznimi ukrepi, so podrobneje opisana v poglavju 4.4: dogodki srčnega popuščanja, hipertenzija, motnje delovanja ščitnice, arterijski tromboembolični dogodki, venski tromboembolični dogodki, zvišanje ravni hemoglobina ali hematokrita, krvavitve, perforacija prebavil in nastanek fistule, zapleti pri celjenju ran, PRES, proteinurija in zvišanje ravni jetrnih encimov.
English: • ketoconazole or itraconazole, used to treat fungal infections;
Slovenian: • ketokonazol ali itrakonazol, ki se uporabljata za zdravljenje glivičnih okužb;
English: Wound healing complications No formal studies of the effect of axitinib on wound healing have been conducted.
Slovenian: Zapleti pri celjenju ran Formalnih študij o vplivu aksitiniba na celjenje ran niso izvedli.
English: Axitinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Slovenian: Aksitinib je treba uporabljati previdno pri bolnikih s tveganjem za pojav teh dogodkov ali anamnezo teh dogodkov.
English: The European Medicines Agency has waived the obligation to submit the results of studies with axitinib in all subsets of the paediatric population for treatment of kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov preskušanj z aksitinibom za vse podskupine pediatrične populacije pri zdravljenju raka ledvic in ledvičnega meha (z izjemo nefroblastoma, nefroblastomatoze, svetloceličnega sarkoma, mezoblastnega nefroma, raka ledvične sredice in rabdoidnega tumorja ledvic) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Tell your doctor if you have severe abdominal pain.
Slovenian: Obvestite zdravnika, če imate hude bolečine v trebuhu.
English: Routine laboratory assessments detected elevated haemoglobin above ULN in 9.7% of patients receiving axitinib.
Slovenian: V rutinskih laboratorijskih preiskavah so zvišane ravni hemoglobina nad ZMN ugotovili pri 9,7 % bolnikov, ki so prejemali aksitinib.
English: Gastrointestinal perforation and fistula formation
Slovenian: Perforacija prebavil in nastanek fistule
English: Pruritus Erythema Alopecia
Slovenian: 4. stopnja eritem alopecija
English: Axitinib should be discontinued if the patient develops nephrotic syndrome.
Slovenian: Zdravljenje z aksitinibom je treba trajno prekiniti, če se pri bolniku pojavi nefrotski sindrom.
English: The most commonly reported liver-related adverse reactions included increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and blood bilirubin (see section 4.8).
Slovenian: Neželeni učinki na jetra, o katerih so poročali najpogosteje, so bili zvišanja ravni alanin aminotransferaze (ALT), aspartat aminotransferaze (AST) in bilirubina v krvi (glejte poglavje 4.8).
English: • If you have had a recent problem with blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
Slovenian: • Če ste pred kratkim imeli težave s krvnimi strdki v venah ali arterijah (vrsti krvnih žil), vključno s kapjo, srčnim infarktom, embolijo ali trombozo.
English: Arterial embolic and thrombotic events
Slovenian: Arterijski embolični in trombotični dogodki
English: Peak axitinib concentrations in plasma are generally reached within 4 hours following oral administration of axitinib with median Tmax ranging from 2.5 to 4.1 hours.
Slovenian: Največje plazemske koncentracije aksitiniba običajno dosežemo v 4 urah po peroralnem dajanju aksitiniba z mediano Tmax od 2,5 do 4,1 ure.
English: Axitinib has not been studied in patients who had an arterial embolic or thrombotic event within the previous 12 months.
Slovenian: Aksitiniba niso preučevali pri bolnikih, pri katerih je do arterijskega emboličnega ali trombotičnega dogodka prišlo v predhodnih 12 mesecih.
English: Inlyta is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when another medicine (called sunitinib or a cytokine) is no longer stopping disease from progressing.
Slovenian: Zdravilo Inlyta se uporablja za zdravljenje napredovalega raka ledvic (napredovalega karcinoma ledvičnih celic) pri odraslih, potem ko z drugim zdravilom (imenovanim sunitinib ali citokin) ni več mogoče zaustaviti napredovanja bolezni.
English: What Inlyta looks like and contents of the pack
Slovenian: Izgled zdravila Inlyta in vsebina pakiranja
English: • Fistula (abnormal tube like passage from one normal body cavity to another body cavity or the skin)
Slovenian: • fistula (nenormalen, cevi podoben prehod iz ene normalne telesne votline do druge telesne votline ali kože)
English: In patients with signs or symptoms of PRES, temporarily interrupt or permanently discontinue axitinib treatment.
Slovenian: Pri bolnikih z znaki ali simptomi PRES je treba zdravljenje z aksitinibom začasno ali trajno prekiniti.
English: Table 1 presents adverse reactions reported in a pooled dataset of 672 patients who received axitinib in clinical studies for the treatment of patients with RCC (see section 5.1).
Slovenian: V preglednici 1 so predstavljeni neželeni učinki, o katerih so poročali pri združenih podatkih 672 bolnikov, ki so prejemali aksitinib v kliničnih preskušanjih pri zdravljenju bolnikov z RCC (glejte poglavje 5.1).
English: The most common (≥ 20%) adverse reactions observed following treatment with axitinib were diarrhoea, hypertension, fatigue, decreased appetite, nausea, weight decreased, dysphonia, palmar-plantar erythrodysaesthesia (hand-foot) syndrome, haemorrhage, hypothyroidism, vomiting, proteinuria, cough, and constipation.
Slovenian: Najpogostejši (≥ 20 %) neželeni učinki, ki so jih opažali po zdravljenju z aksitinibom, so bili driska, hipertenzija, utrujenost, zmanjšan apetit, navzea, zmanjšana telesna masa, hripavost, sindrom palmarno-plantarne eritrodisestezije (sindrom dlani-podplati), krvavitev, hipotiroidizem, bruhanje, proteinurija, kašelj in zaprtost.
English: The recommended dose of axitinib is 5 mg twice daily.
Slovenian: Priporočeni odmerek aksitiniba je 5 mg dvakrat na dan.
English: • rifampicin, rifabutin or rifapentin, used to treat tuberculosis (TB);
Slovenian: • rifampicin, rifabutin ali rifapentin, ki se uporabljajo za zdravljenje tuberkuloze;
English: If you experience dizziness and/or feel tired while on treatment with Inlyta, take special care when driving or using machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če vas obide omotica in/ali ste med jemanjem zdravila Inlyta utrujeni, bodite pri vožnji ali upravljanju strojev še posebno previdni.
English: It is important to check your blood pressure before you take this medicine, and regularly while you are taking it.
Slovenian: Pomembno je, da se pred začetkom jemanja tega zdravila in v rednih časovnih presledkih med jemanjem pri vas preverja krvni tlak.
English: Axitinib inhibited the phosphorylation of VEGFR-2 in xenograft tumour vasculature that expressed the target in vivo and produced tumour growth delay, regression, and inhibition of metastases in many experimental models of cancer.
Slovenian: Aksitinib je zavrl fosforilacijo VEGFR-2 pri vaskulaturi heterolognega tumorskega presadka, ki je in vivo izpostavila tarčo, to zavrtje pa je pri številnih eksperimentalnih modelih rakavih obolenj povzročilo upočasnitev rasti tumorja, regresijo in zavrtje metastaz.
English: • Shortness of breath, cough, hoarseness
Slovenian: • kratka sapa, kašelj, hripavost
English: Therefore, co-administration of axitinib is not expected to increase the plasma concentration of digoxin, or other P-glycoprotein substrates,
Slovenian: Zato ni pričakovati, da bi sočasna uporaba aksitiniba zvečala plazemsko koncentracijo digoksina ali drugih substratov P-glikoproteina in vivo.
English: Venous embolic and thrombotic events
Slovenian: Venski embolični in trombotični dogodki
English: Your treatment with this medicine should be restarted when the wound has adequately healed.
Slovenian: Potem ko se rana zadovoljivo zaceli, je treba ponovno začeti zdravljenje s tem zdravilom.
English: A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily).
Slovenian: Zmanjšanje odmerka je priporočljivo, kadar se aksitinib daje bolnikom z zmerno okvaro jeter (razred B po Child-Pughu) (npr. začetni odmerek 5 mg dvakrat na dan je treba zmanjšati na 2 mg dvakrat na dan).
English: Inlyta may increase the risk of developing heart failure events.
Slovenian: Zdravilo Inlyta lahko zveča tveganje za razvoj srčnega popuščanja.
English: Therefore, coadministration of axitinib with CYP1A2 substrates may result in increased plasma concentrations of CYP1A2 substrates (e.g. theophylline).
Slovenian: Zato lahko sočasno dajanje aksitiniba skupaj s substrati CYP1A2 povzroči zvečanje plazemskih koncentracij substratov CYP1A2 (npr. teofilina).
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, one patient inadvertently received a dose of 20 mg twice daily for 4 days and experienced dizziness (Grade 1).
Slovenian: V nadzorovanem kliničnem preskušanju z aksitinibom pri zdravljenju bolnikov z RCC je en bolnik nenamerno prejemal odmerek 20 mg dvakrat na dan v obdobju štirih dni, pri tem pa je pri njem prišlo do pojava omotice (1. stopnje).
English: Inlyta may increase the risk of developing a hole in the stomach or intestine or formation of fistula (abnormal tube-like passage from one normal body cavity to another body cavity or the skin).
Slovenian: Zdravilo Inlyta lahko zveča tveganje za predrtje želodca ali črevesa ali za nastanek fistule (nenormalen, cevi podoben prehod iz ene normalne telesne votline do druge telesne votline ali kože).
English: Maximal induction with high-dose strong CYP3A4/5 inducers has been reported to occur within one week of treatment with the inducer.
Slovenian: Poročali so, da pri uporabi velikih odmerkov močnih induktorjev CYP3A4/5 do največje indukcije pride v enem tednu po začetku zdravljenja z induktorjem.
English: • Do not breast-feed during treatment with Inlyta.
Slovenian: • Med zdravljenjem z zdravilom Inlyta ne smete dojiti.
English: At the 5 mg twice daily dose in the fed state, the geometric mean peak plasma concentration and 24-hour AUC were 27.8 ng/mL and 265 ng.h/mL, respectively, in patients with advanced RCC.
Slovenian: Pri odmerku 5 mg dvakrat na dan na poln želodec sta pri bolnikih z napredovalim RCC geometrični srednji vrednosti največje plazemske koncentracije in 24-urna vrednost AUC znašali 27,8 ng/ml oziroma 265 ng.h/ml.
English: Co-administration of axitinib with strong CYP3A4/5 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, erythromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin) may increase axitinib plasma concentrations.
Slovenian: Sočasna uporaba aksitiniba z močnimi zaviralci CYP3A4/5 (npr. ketokonazol, itrakonazol, klaritromicin, eritomicin, atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, sakvinavir in telitromicin) lahko zveča plazemske koncentracije aksitiniba.
English: In vitro studies in human hepatocytes also indicated that axitinib does not induce CYP1A1, CYP1A2, or CYP3A4/5.
Slovenian: Študije in vitro na človeških hepatocitih so prav tako pokazale, da aksitinib ne inducira CYP1A1, CYP1A2 ali CYP3A4/5.
English: Patients should be advised that they may experience events such as dizziness and/or fatigue during treatment with axitinib.
Slovenian: Bolnikom je treba povedati, da se med zdravljenjem z aksitinibom lahko pojavijo učinki, kot je npr. omotica in/ali utrujenost.
English: b National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 c See Description of selected adverse reactions section.
Slovenian: merila NCI za poenoteno terminologijo neželenih dogodkov [National Cancer Institute Common Terminology Criteria for Adverse Events], različica 3.0
English: Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans (see section 5.3).
Slovenian: Predklinični izsledki kažejo, da aksitinib lahko neugodno vpliva na sposobnost razmnoževanja in plodnost pri ljudeh (glejte poglavje 5.3).
English: ORR b,e % (95% CI)
Slovenian: % (95 % IZ)
English: d Cutoff date: 01 November 2011.
Slovenian: Presečni datum: 1. november 2011.
English: Axitinib has not been studied in patients who had a venous embolic or thrombotic event within the previous 6 months.
Slovenian: Aksitiniba niso preučevali pri bolnikih, pri katerih je do venskega emboličnega ali trombotičnega dogodka prišlo v predhodnih 6 mesecih.
English: Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
Slovenian: Zdravilo Inlyta je indicirano za zdravljenje napredovalega karcinoma ledvičnih celic (RCC - Renal Cell Carcinoma) pri odraslih bolnikih, pri katerih predhodno zdravljenje s sunitinibom ali citokinom ni bilo uspešno.