FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Afinitor if you are allergic to everolimus, to related substances such as sirolimus or temsirolimus, or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Afinitor ako ste alergični na everolimus, na srodne tvari kao što su sirolimus ili temsirolimus, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Physicians and patients should be aware of the increased risk of infection with Afinitor.
Croatian: Liječnici i bolesnici moraju biti svjesni povećanog rizika za nastanak infekcije tijekom primjene Afinitora.
English: RADIANT-3 involved patients with well- and moderately-differentiated advanced pNET whose disease had progressed within the prior 12 months.
Croatian: Ispitivanje RADIANT-3 uključivalo je bolesnike s dobro i umjereno diferenciranim uznapredovalim pNET-om čija je bolest napredovala tijekom prethodnih 12 mjeseci.
English: What Afinitor is and what it is used for What you need to know before you take Afinitor How to take Afinitor
Croatian: Što je Afinitor i za što se koristi Što morate znati prije nego počnete uzimati Afinitor Kako uzimati Afinitor
English: Poor risk a
Croatian: Nizak rizik a
English: You will have regular blood tests during treatment.
Croatian: Tijekom liječenja će Vam redovito raditi pretrage krvi.
English: • Menstruation disorders such as absence of periods (amenorrhoea)
Croatian: • Menstrualni poremećaji kao što su izostanak menstruacije (amenoreja)
English: Common Haemorrhage b, hypertension
Croatian: Hemoragija b, hipertenzija
English: More frequent monitoring is recommended when Afinitor is co-administered with other medicinal products that may induce hyperglycaemia.
Croatian: Preporučuje se češće praćenje kada se Afinitor istodobno primjenjuje s drugim lijekovima koji mogu inducirati hiperglikemiju.
English: Afinitor could harm your breast-fed baby.
Croatian: Afinitor može naštetiti Vašem dojenčetu.
English: These will check the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see if Afinitor is having an unwanted effect on these cells.
Croatian: Time se provjerava količina krvnih stanica (bijelih krvnih stanica, crvenih krvnih stanica i krvnih pločica) u Vašem organizmu i tako utvrđuje ima li Afinitor kakvog neželjenog učinka na spomenute stanice.
English: This dose of Afinitor is predicted to adjust the AUC to the range observed without inducers.
Croatian: Predviđa se da će ta doza Afinitora prilagoditi AUC na raspon uočen bez induktora.
English: Tell your doctor if you experience these symptoms.
Croatian: Obavijestite svog liječnika ako primijetite navedene simptome.
English: Some of these infections have been severe (e.g. leading to sepsis, respiratory or hepatic failure) and occasionally fatal.
Croatian: Neke od ovih infekcija su bile teške (npr. dovele su do sepse, zatajenja disanja ili jetre) i ponekad smrtonosne.
English: • Menstruation disorders such as irregular periods
Croatian: • Menstrualni poremećaji kao što su neredovite menstruacije
English: The number of patients with an adverse reaction leading to discontinuation of the medicinal product was higher in patients ≥65 years of age (20% vs. 13%).
Croatian: Broj bolesnika s nuspojavama zbog kojih je došlo do prekida primjene lijeka bio je viši u bolesnika s ≥65 godina (20% u odnosu na 13%).
English: For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for PJP/PCP may be considered.
Croatian: U bolesnika koji zahtijevaju primjenu kortikosteroida za liječenje neinfektivnog pneumonitisa može se razmotriti profilaksa PJP/PCP.
English: (20.9 to 32.4)
Croatian: (20,9 do 32,4)
English: Everolimus is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se primjena everolimusa u trudnoći i u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Yes (N=157) No (N=145) Yes (N=77)
Croatian: Da (N=157) Ne (N=145) Da (N=77)
English: Severe hepatic impairment (Child-Pugh C) - Afinitor is only recommended if the desired benefit outweighs the risk.
Croatian: Teško oštećenje funkcije jetre (Child-Pugh C) - Afinitor se preporučuje samo ako željena dobit od liječenja premašuje potencijalni rizik.
English: Functional carcinoid tumours
Croatian: Funkcionalni karcinoidni tumori
English: Clinical benefit rate = proportion of patients with complete or partial response or stable disease ≥24 weeks d
Croatian: Stopa kliničke dobiti = udio bolesnica s potpunim ili djelomičnim odgovorom ili stabilnom bolešću ≥24 tjedna d
English: No (N=225) Lung (N=90) Ileum (N=71) Non-ileum* (N=141) Grade 1 (N=194) Grade 2 (N=107) ≤10% (N=228) >10% (N=72) >2xULN (N=139) ≤2xULN (N=138) >ULN (N=87) ≤ULN (N=188)
Croatian: Ne (N=225) Pluća (N=90) Ileum (N=71) Ne-ileum* (N=141) Gradus 1 (N=194) Gradus 2 (N=107) ≤10% (N=228) >10% (N=72) >2xGGN (N=139) ≤2xGGN (n=138) >GGN (N=87) ≤GGN (N=188)
English: Therefore, the progression-free survival advantage primarily reflects the population with disease stabilisation (corresponding to 67% of the Afinitor treatment group).
Croatian: Zbog toga se prednost u preživljenju bez progresije bolesti prvenstveno odnosi na populaciju u kojoj je bolest postala stabilna (što predstavlja 67% bolesnika u skupini liječenoj Afinitorom).
English: S6K1is thought to phosphorylate the activation function domain 1 of the oestrogen receptor, which is responsible for ligand-independent receptor activation.
Croatian: Smatra se da S6K1 fosforilira aktivacijsku funkcionalnu domenu 1 estrogenskog receptora, koja je odgovorna za aktivaciju receptora neovisnu o ligandu.
English: Single doses of up to 70 mg have been given with acceptable acute tolerability.
Croatian: Jednokratne doze do 70 mg su davane uz prihvatljivu akutnu podnošljivost u odrasloj populaciji.
English: If you forget to take Afinitor
Croatian: Ako ste zaboravili uzeti Afinitor
English: Therefore, the safety and efficacy of Afinitor in patients with functional carcinoid tumours have not been established.
Croatian: Stoga, sigurnost primjene i djelotvornost Afinitora u bolesnika s funkcionalnim karcinoidnim tumorima nije utvrđena.
English: Elderly patients (≥65 years) No dose adjustment is required (see section 5.2).
Croatian: Stariji bolesnici (≥65 godina) Nije potrebna prilagodba doze (vidjeti dio 5.2).
English: • Loss of sense of taste (ageusia)
Croatian: • Gubitak osjeta okusa (ageuzija)
English: Administration of everolimus for up to 2 years did not indicate any oncogenic potential in mice and rats up to the highest doses, corresponding respectively to 3.9 and 0.2 times the estimated clinical exposure.
Croatian: Primjena everolimusa u trajanju do 2 godine, nije pokazala onkogeni potencijal u miševa odnosno štakora čak ni u najvišim dozama koje odgovaraju dozi 3,9 odnosno 0,2 puta višoj od procijenjene kliničke izloženosti.
English: No difference in the time to definitive deterioration of WHO PS (≥1 point) and time to definitive deterioration in quality of life (FACT-G total score ≥7 points) was observed between the two arms.
Croatian: Nije opažena razlika u vremenu do definitivnog pogoršanja funkcionalnog stanja prema SZO-u (≥1 bod) i vremena do definitivnog pogoršanja kvalitete života (ukupni rezultat na FACT-G-u ≥7 bodova) između dviju skupina.
English: All (N=302) <65 years (N=159) ≥65 years (N=143) 0 (N=216) 1 (N=86)
Croatian: Svi (N=302) <65 godina (N=159) ≥65 godina (N=143) 0 (N=216) 1 (N=86)
English: Limited evidence of PFS benefit was reported in the subgroup of patients with ileum as primary tumour origin (see section 5.1).
Croatian: Ograničeni dokaz PFS koristi je prijavljen u podskupini bolesnika s ileumom kao primarnim sijelom tumora (vidjeti dio 5.1)
English: No statistically significant treatment-related difference in overall survival was noted (hazard ratio 0.87; confidence interval: 0.65-1.17; p=0.177).
Croatian: Nije zabilježena statistički značajna razlika s obzirom na liječenje u ukupnom preživljenju (omjer hazarda 0,87; interval pouzdanosti: 0,65-1,17; p=0,177).
English: Everolimus reduces levels of vascular endothelial growth factor (VEGF), which potentiates tumour angiogenic processes.
Croatian: Everolimus snižava razine vaskularnog endotelnog čimbenika rasta (VEGF) koji potencira procese tumorske angiogeneze.
English: Blood tests will also be carried out to check your kidney function (level of creatinine) and liver function (level of transaminases) and your blood sugar and cholesterol levels.
Croatian: Krvne pretrage bit će učinjene i s ciljem provjere funkcije Vaših bubrega (razina kreatinina) i funkcije Vaše jetre (razina transaminaza) te provjere razina šećera i kolesterola u Vašoj krvi.
English: Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.
Croatian: Everolimus smanjuje opskrbu tumora krvlju te usporava rast i širenje stanica raka.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE10
Croatian: Farmakoterapijska skupina: Antineoplastici, ostali antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE10
English: Kaplan-Meier medians Everolimus: 4.90 months Placebo: 1.87 months
Croatian: Kaplan-Meierovi medijani Everolimus: 4,90 mjeseci Placebo: 1,87 mjeseci
English: If you are taking any of them, your doctor may switch you to a different medicine, or may change your dose of Afinitor.
Croatian: Uzimate li bilo koji od njih, Vaš liječnik može odlučiti propisati Vam neki drugi lijek ili izmijeniti Vašu dozu Afinitora.
English: Renal function should be monitored particularly where patients have additional risk factors that may further impair renal function.
Croatian: Potrebno je pratiti funkciju bubrega osobito u bolesnika koji imaju dodatne rizične čimbenike koji bi mogli dodatno oštetiti funkciju bubrega.
English: Uncommon Amenorrhoea e*
Croatian: Manje često Amenoreja e*
English: If you stop taking Afinitor Do not stop taking Afinitor unless your doctor tells you to.
Croatian: Afinitor nemojte prestati uzimati sve dok Vam to ne kaže Vaš liječnik.
English: Patients should be advised to be cautious when driving or using machines if they experience fatigue during treatment with Afinitor.
Croatian: Bolesnicima je potrebno savjetovati da budu oprezni pri upravljanju vozilima ili radu sa strojevima ako tijekom liječenja Afinitorom osjete umor.
English: Six-month PFS rates were 36% for Afinitor therapy compared with 9% for placebo.
Croatian: Šestomjesečne stope preživljenja bez progresije bolesti bile su 36% za terapiju Afinitorom u usporedbi s 9% za placebo.
English: 30 tablets 90 tablets
Croatian: 30 tableta 90 tableta
English: If a diagnosis of invasive systemic fungal infection is made, the Afinitor treatment should be promptly and permanently discontinued and the patient treated with appropriate antifungal therapy.
Croatian: Ako je postavljena dijagnoza invazivne sistemske gljivične infekcije, liječenje Afinitorom potrebno je odmah i trajno prekinuti i u bolesnika provesti odgovarajuće antifungalno liječenje.
English: Sensitivity to prior hormonal therapy was defined as either (1) documented clinical benefit (complete response [CR], partial response [PR], stable disease ≥24 weeks) from at least one prior hormonal therapy in the advanced setting or (2) at least 24 months of adjuvant hormonal therapy prior to recurrence.
Croatian: Osjetljivost na prethodno hormonsko liječenje bila je definirana ili kao (1) dokumentirana klinička dobit (potpuni odgovor, djelomičan odgovor, stabilna bolest ≥24 tjedna) od najmanje jedne linije hormonskog liječenja u uznapredovaloj bolesti, ili kao (2) najmanje 24 mjeseca adjuvantnog hormonskog liječenja prije recidiva bolesti.
English: Afinitor may have an impact on female fertility.
Croatian: Afinitor može utjecati na plodnost žene.
English: Prior therapy with bevacizumab and interferon-α was also permitted.
Croatian: Prethodno liječenje bevacizumabom i interferonom-α također je bilo dopušteno.
English: Carbamazepine, phenobarbital, phenytoin
Croatian: Karbamazepin, fenobarbital, fenitoin
English: Afinitor was superior to placebo for the primary endpoint of progression-free survival, with a statistically significant 67% reduction in the risk of progression or death (see Table 7 and Figure 6).
Croatian: Afinitor je bio bolji od placeba s obzirom na primarni ishoda preživljenja bez progresije bolesti, uz statistički značajno sniženje rizika za progresiju bolesti ili smrt od 67% (vidjeti Tablicu 7 i Sliku 6).
English: Afinitor contains lactose
Croatian: Afinitor sadrži laktozu
English: • Swelling of arms, hands, feet, ankles or other part of the body (signs of oedema)
Croatian: • Oticanje ruku, šaka, stopala, gležnjeva ili drugih dijelova tijela (znakovi edema)
English: Management of stomatitis may therefore include prophylactic and/or therapeutic use of topical treatments, such as an alcohol-free corticosteroid oral solution as a mouthwash.
Croatian: Zbrinjavanje stomatitisa stoga može uključivati profilaktičku i/ili terapijsku primjenu topikalnih pripravaka, kao što je uporaba bezalkoholne oralne otopine kortikosteroida kao otopine za ispiranje usta.
English: How to store Afinitor
Croatian: Kako čuvati Afinitor
English: Everolimus has immunosuppressive properties and may predispose patients to bacterial, fungal, viral or protozoan infections, including infections with opportunistic pathogens (see section 4.8).
Croatian: Everolimus ima imunosupresivna svojstva i može povećati sklonost bolesnika prema bakterijskim, gljivičnim, virusnim ili protozoalnim infekcijama, uključujući infekcije uzrokovane oportunističkim uzročnicima (vidjeti dio 4.8).
English: The median PFS was 8.4 months (90% CI: 6.6, 9.7) and 6.8 months (90% CI: 5.5, 7.2), respectively.
Croatian: Medijan preživljenja bez progresije bolesti bio je 8,4 mjeseci (90% CI: 6,6, 9,7), odnosno 6,8 mjeseci (90% CI: 5,5, 7,2).
English: Hyperglycaemia has been reported (see section 4.8).
Croatian: Prijavljena je hiperglikemija (vidjeti dio 4.8).
English: The preclinical safety profile of everolimus was assessed in mice, rats, minipigs, monkeys and rabbits.
Croatian: Neklinički profil sigurnosti everolimusa bio je ispitivan u miševa, štakora, patuljastih svinja, majmuna i kunića.
English: Following disease progression or after study unblinding, 172 of the 203 patients (84.7%) initially randomised to placebo crossed over to open-label Afinitor.
Croatian: Nakon progresije bolesti ili nakon otkrivanja terapije koju su primali bolesnici, 172 od 203 bolesnika (84,7%) inicijalno randomiziranih na placebo prešlo je na Afinitor u otvorenom dijelu ispitivanja.
English: Afinitor may increase blood sugar levels and worsen diabetes mellitus.
Croatian: Afinitor može povisiti razinu šećera u krvi i pogoršati šećernu bolest.
English: If you experience certain side effects while you are taking Afinitor (see section 4), your doctor may lower your dose or stop treatment, either for a short time or permanently.
Croatian: Jave li se za vrijeme trajanja liječenja Afinitorom u Vas određene nuspojave (vidjeti dio 4), Vaš liječnik može odlučiti sniziti dozu lijeka ili prekinuti liječenje, bilo privremeno, bilo trajno.
English: Supportive PFS analysis was based on local investigator review.
Croatian: Suportivna analiza PFS-a temeljila se na procjeni lokalnog ispitivača.
English: One-sided p-value from a stratified log-rank test
Croatian: Jednostrana p-vrijednost iz stratificiranog log-rang testa
English: • Increased temperature, chills (signs of infection)
Croatian: • Povišena temperatura, zimica (znakovi infekcije)
English: If dose reduction is required, the recommended dose is 5 mg daily and must not be lower than 5 mg daily.
Croatian: Ako je potrebno smanjenje doze, preporučuje se doza od 5 mg dnevno pri čemu doza ne smije biti manja od 5 mg dnevno.
English: A clinically significant effect on the efficacy response to everolimus in patients with advanced neuroendocrine tumours could not be established.
Croatian: Ne može se utvrditi klinički značajan učinak na djelotvornost everolimusa u bolesnika s uznapredovalim neuroendokrinim tumorima.
English: Time (weeks) Everolimus/Exemestane Everolimus
Croatian: Vrijeme (tjedni) Everolimus/eksemestan Everolimus
English: Censoring Times
Croatian: Vrijeme cenzuriranja
English: General supportive measures should be initiated in all cases of overdose.
Croatian: U svim slučajevima predoziranja potrebno je provoditi opće potporne mjere.
English: Co-administration of everolimus and exemestane increased exemestane Cmin and C2h by 45% and 64%, respectively.
Croatian: Istodobna primjena everolimusa i eksemestana povećala je Cmin i C2h eksemestana za 45% odnosno 64%.
English: Afinitor may increase the risk of problems with wound healing.
Croatian: Afinitor može povećati rizik za probleme vezane uz cijeljenje rane.
English: However, oral doses of everolimus in female rats at ≥0.1 mg/kg (approximately 4% of the AUC0-24h in patients receiving the 10 mg daily dose) resulted in increases in pre-implantation loss.
Croatian: Međutim, peroralne doze everolimusa u ženki štakora pri dozi od ≥0,1 mg/kg (otprilike 4% AUC0-24h u bolesnika koji primaju dnevnu dozu od 10 mg) rezultirale su povećanjem u gubitku ploda prije implantacije.
English: Blood and lymphatic system disorders Very common Anaemia
Croatian: Poremećaji krvi i limfnog sustava Vrlo često Anemija Često
English: If, despite these measures, you think you may have become pregnant, ask your doctor for advice before taking any more Afinitor.
Croatian: Ukoliko, unatoč ovim mjerama, mislite da ste mogli ostati u drugom stanju, posavjetujte se sa svojim liječnikom prije nego nastavite uzimati Afinitor.
English: Table 1 summarises the dose adjustment recommendations for specific adverse reactions (see also section 4.4).
Croatian: Tablica 1 sadrži sažetak preporuka za prilagođavanje doze kod specifičnih nuspojava (vidjeti također dio 4.4).
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis, candidiasis or PJP/PCP and viral infections including reactivation of hepatitis B virus, have been described in patients taking Afinitor.
Croatian: Lokalizirane i sistemske infekcije, uključujući upalu pluća, druge bakterijske infekcije, invazivne gljivične infekcije, kao što je aspergiloza, kandidijaza ili PJP/PCP i virusne infekcije uključujući reaktivaciju hepatitis B virusa, opisane su u bolesnika koji su uzimali Afinitor.
English: • swelling of the face, lips, tongue or throat
Croatian: • oticanje lica, usnica, jezika ili vrata
English: When possible optimal glycaemic control should be achieved before starting a patient on Afinitor.
Croatian: Kada je moguće, treba postići optimalnu kontrolu glukoze u krvi prije nego bolesnik počne uzimati Afinitor.
English: The immune response to vaccination may be affected and, therefore, vaccination may be less effective during treatment with Afinitor.
Croatian: Afinitor može utjecati na imunološki odgovor na cijepljenje, pa stoga cijepljenje može biti manje djelotvorno tijekom liječenja Afinitorom.
English: Patients who develop radiological changes suggestive of non-infectious pneumonitis and have few or no symptoms may continue Afinitor therapy without dose adjustments.
Croatian: Bolesnici u kojih se razviju radiološke promjene koje govore u prilog neinfektivnog pneumonitisa, a koji imaju malo simptoma, ili uopće nemaju simptoma, mogu nastaviti liječenje Afinitorom bez prilagodbe doze.
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with everolimus (see section 5.3).
Croatian: Na temelju nekliničkih podataka, plodnost u muškaraca i žena može biti smanjena zbog liječenja everolimusom (vidjeti dio 5.3).
English: • Abnormal results of liver blood tests (increased alanine and aspartate aminotransferase)
Croatian: • Poremećeni rezultati testova jetrene funkcije u krvi (povišeni alanin i aspartat aminotransferaza)
English: Hazard ratio (95% CI) from stratified Cox model
Croatian: Omjer hazarda (95% CI) iz stratificiranog Coxovog modela.
English: Concomitant treatment with potent CYP3A4 inhibitors result in dramatically increased plasma concentrations of everolimus (see section 4.5).
Croatian: Istodobno liječenje s potentnim inhibitorima CYP3A4 dovodi do dramatičnog povišenja koncentracije everolimusa u plazmi (vidjeti dio 4.5).
English: Exposure to everolimus was increased in patients with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment (see section 5.2).
Croatian: Izloženost everolimusu bila je povećana u bolesnika s blagim (Child-Pugh A), umjerenim (Child-Pugh B) i teškim (Child-Pugh C) oštećenjem funkcije jetre (vidjeti dio 5.2).
English: • Bleeding (haemorrhage), for example in the gut wall
Croatian: • Krvarenje (hemoragija), na primjer u stijenci crijeva
English: • Weakness, spontaneous bleeding or bruising and frequent infections with signs such as fever,
Croatian: • Slabost, spontano krvarenje ili pojava modrica i česte infekcije sa znakovima poput vrućice,
English: Demographics were well balanced (median age 58 years, 55% male, 78.5% Caucasian).
Croatian: Skupine su bile dobro uravnotežene prema demografskim karakteristikama (medijan dobi od 58 godina, 55% muški, 78,5% bijelci).
English: Median overall survival (months) (95% CI) Median overall survival
Croatian: Medijan ukupnog preživljenja (mjeseci) (95% CI) Medijan ukupnog preživljenja
English: • Dry skin, skin exfoliation, skin lesions
Croatian: • Suha koža, ljuštenje kože, rane na koži
English: • Sudden onset of shortness of breath, chest pain or coughing up blood (potential signs of pulmonary embolism, a condition that occurs when one or more arteries in your lungs become blocked)
Croatian: • Iznenadan nedostatak zraka, bol u prsnom košu ili iskašljavanje krvi (mogući znakovi plućne embolije, stanja koje se javlja kada se jedna ili više arterija u plućima začepi)
English: At the time of the final OS analysis, the median duration of everolimus treatment was 24.0 weeks (range 1.0-199.1 weeks).
Croatian: U trenutku konačne analize ukupnog preživljenja, medijan trajanja liječenja everolimusom bio je 24,0 tjedana (raspon 1,0-199,1 tjedana).
English: In the first study, the average AUC of everolimus in 8 subjects with moderate hepatic impairment (Child-Pugh B) was twice that found in 8 subjects with normal hepatic function.
Croatian: U prvom ispitivanju, prosječni AUC everolimusa u 8 ispitanika s umjerenim oštećenjem jetre (Child-Pugh B) bio je dvostruko veći od AUC-a uočenoga u 8 ispitanika s normalnom funkcijom jetre.
English: Table 3 presents the frequency category of adverse reactions reported in the pooled analysis considered for the safety pooling.
Croatian: U Tablici 3 prikazana je kategorija učestalosti nuspojava prijavljenih u objedinjenoj analizi razmatranoj za sigurnosno praćenje.
English: If you are taking other medicines at the same time as Afinitor, your doctor may need to change the dose of Afinitor or the other medicines.
Croatian: Uzimate li istodobno s Afinitorom i druge lijekove, Vaš liječnik će dozu Afinitora ili tih drugih lijekova možda morati promijeniti.
English: Table 7 RECORD-1 - Progression-free survival results
Croatian: Tablica 7 RECORD-1 - Rezultati za preživljenje bez progresije bolesti
English: After documented radiological progression, patients could be unblinded by the investigator: those randomised to placebo were then able to receive open-label everolimus 10 mg/day.
Croatian: Nakon dokumentirane radiološke progresije, ispitivač je mogao otkriti terapiju koju su primali bolesnici: oni koji su bili randomizirani u skupinu koja je primala placebo mogli su nakon toga primati everolimus 10 mg/dan u otvorenom dijelu ispitivanja.
English: The recommended dose is 10 mg, taken once a day.
Croatian: Preporučena doza je 10 mg jednom dnevno.
English: No clinical safety or efficacy data are currently available to support dose adjustment recommendations for the management of adverse reactions in patients with hepatic impairment.
Croatian: Trenutačno nema dostupnih podataka o kliničkoj sigurnosti ili djelotvornosti na temelju kojih bi se mogle donijeti preporuke o prilagođavanju doze za zbrinjavanje nuspojava u bolesnika s oštećenjem jetre.