FrancophonIA/ELRC3.0 huggingface dataset:
English: The major target organs were male and female reproductive systems (testicular tubular degeneration, reduced sperm content in epididymides and uterine atrophy) in several species; lungs (increased alveolar macrophages) in rats and mice; pancreas (degranulation and vacuolation of exocrine cells in monkeys and minipigs, respectively, and degeneration of islet cells in monkeys), and eyes (lenticular anterior suture line opacities) in rats only.
Croatian: Najčešći ciljni organi su bili muški i ženski reproduktivni sustav (testikularna tubularna degeneracija, smanjen sadržaj sperme u epididimusu i atrofija uterusa) u nekoliko vrsta; pluća (povećani broj alveolarnih makrofaga) u štakora i miševa; gušterača (degranulacija i vakuolizacija egzokrinih stanica u majmuna odnosno u patuljastih svinja te degeneracija stanica otočića u majmuna) te oči samo u štakora (zamućenje prednje linije leće).
English: Regular blood tests are also necessary to measure how much Votubia is in your blood since this will help your doctor decide how much Votubia you need to take.
Croatian: Redovite krvne pretrage nužne su i zato da bi se izmjerila količina Votubie u Vašoj krvi, što će Vašem liječniku pomoći da odluči koliko Votubie trebate uzimati.
English: Everolimus whole blood trough concentrations should be assessed at least 1 week after any change in hepatic status (Child-Pugh).
Croatian: Najniže koncentracije everolimusa u punoj krvi potrebno je odrediti najmanje 1 tjedan nakon bilo kakve promjene u statusu jetre (Child-Pugh).
English: Take the 10 ml oral syringe and pull out the plunger, removing it completely from the barrel of the syringe.
Croatian: Uzmite štrcaljku za usta od 10 ml i izvucite klip te ga potpuno izvadite iz trupa štrcaljke.
English: Limited data in patients <3 years of age (n=13) indicate that BSA-normalised clearance is about two-fold higher in patients with low BSA (BSA of 0.556 m2) than in adults.
Croatian: Ograničeni podaci u bolesnika mlađih od 3 godine (n=13) ukazuju da je klirens normaliziran na površinu tijela (PT) oko 2 puta viši u bolesnika s niskim PT-om (PT od 0,556 m2) nego u odraslih.
English: Based on the results of the two studies, dose adjustment is recommended for patients with hepatic impairment (see sections 4.2 and 4.4).
Croatian: Na temelju rezultata ovih dvaju ispitivanja, za bolesnike s oštećenjem funkcije jetre preporučuje se prilagodba doze (vidjeti dijelove 4.2 i 4.4).
English: Preparations containing St John's Wort should not be used during treatment with everolimus
Croatian: Pripravci koji sadrže gospinu travu se ne smiju koristiti tijekom liječenja everolimusom
English: Stable disease Progression
Croatian: Stabilna bolest
English: Concomitant treatment with potent CYP3A4 inhibitors result in dramatically increased blood concentrations of everolimus (see section 4.5).
Croatian: Istodobno liječenje s potentnim inhibitorima CYP3A4 dovodi do dramatičnog povišenja koncentracije everolimusa u krvi (vidjeti dio 4.5).
English: On rare occasions, fatal outcomes were observed in the oncology setting (see section 4.4).
Croatian: U rijetkim slučajevima uočeni su smrtni ishodi kod onkoloških bolesti (vidjeti dio 4.4).
English: Genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of clastogenic or mutagenic activity.
Croatian: Ispitivanja genotoksičnosti koja su obuhvatila sve značajne ishode genotoksičnosti nisu pokazala klastogenu, odnosno mutagenu aktivnost lijeka.
English: Kidney disorders: altered frequency or absence of urination may be symptoms of kidney failure and have been observed in some patients receiving everolimus.
Croatian: Poremećaji bubrega: promijenjena učestalost ili izostanak mokrenja mogu biti simptomi zatajenja bubrega i bili su zabilježeni u nekih bolesnika koji su primali everolimus.
English: Secondary endpoints included seizure freedom, proportion of patients with >25% seizure frequency reduction from baseline, distribution of reduction from baseline in seizure frequency (≤-25%, >-25% to <25%; ≥25% to <50%; ≥50% to <75%; ≥75% to <100%; 100%), long-term evaluation of seizure frequency and overall quality of life.
Croatian: Mjere sekundarnog ishoda uključivale su izostanak napadaja, udio bolesnika sa smanjenjem učestalosti napadaja >25% u odnosu na početnu vrijednost, distribuciju smanjenja učestalosti napadaja u odnosu na početnu vrijednost (≤-25%, >-25% do <25%; ≥25% do <50%; ≥50% do <75%; ≥75% do <100%; 100%), dugoročnu ocjenu učestalosti napadaja i cjelokupnu kvalitetu života.
English: Treatment with Votubia should be initiated by a physician experienced in the treatment of patients with TSC and therapeutic drug monitoring.
Croatian: Liječenje Votubiom mora započeti liječnik s iskustvom u liječenju bolesnika s KTS-om i praćenju terapijskih učinaka lijeka.
English: The everolimus trough concentrations should be assessed 2 to 4 weeks later since the natural degradation time of the induced enzymes has to be taken into account (see sections 4.2 and 4.4).
Croatian: Najniže koncentracije everolimusa potrebno je odrediti 2 do 4 tjedna kasnije, jer se mora uzeti u obzir vrijeme prirodne razgradnje induciranih enzima (vidjeti dijelove 4.2 i 4.4).
English: Pre-existing infections should be treated appropriately and should have resolved fully before starting treatment with Votubia.
Croatian: Već postojeće infekcije potrebno je pravilno liječiti i potpuno izliječiti prije početka liječenja Votubiom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Votubia in all subsets of the paediatric population in angiomyolipoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Votubia u svim podskupinama pedijatrijske populacije u angiomiolipomu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Not studied.
Croatian: Nije ispitano.
English: Monitoring of renal function is recommended (see section 4.4).
Croatian: Preporučuje se praćenje bubrežne funkcije (vidjeti dio 4.4).
English: If you are taking an anti-seizure medicine, a change in the dose of the anti-seizure medicine (increase or decrease) may make a change in the Votubia dose necessary.
Croatian: Uzimate li neki od antiepileptika, promjena u dozi antiepileptika (bilo njezino povišenje, bilo njezino sniženje) može nametnuti potrebu za promjenom doze Votubie koju uzimate.
English: The dose may be increased to attain a higher trough concentration within the target range to obtain optimal efficacy, subject to tolerability.
Croatian: Dozu je moguće povećati kako bi se postigla viša vrijednost najniže koncentracije unutar ciljanog raspona te tako postigla optimalna djelotvornost, ovisno o podnošljivosti lijeka.
English: At weeks 12, 96 and 192, ≥ 30% reductions in volume were observed in 75.0%, 80.6%, and 85.2% of the treated patients, respectively.
Croatian: U 12., 96. i 192. tjednu, uočena su smanjenja u volumenu ≥30% u 75,0%, 80,6%, odnosno 85,2% liječenih bolesnika.
English: In clinical trials and post-marketing spontaneous reports, angioedema has been reported with and without concomitant use of ACE inhibitors (see section 4.4).
Croatian: U kliničkim ispitivanjima i izvještajima nakon stavljanja lijeka u promet, prijavljen je angioedem sa i bez istodobne primjene ACE inhibitora (vidjeti dio 4.4).
English: In healthy subjects taking a single 9 mg dose (3 x 3 mg) of Votubia dispersible tablets in suspension, high fat meals reduced AUC by 11.7% and the peak blood concentration Cmax by 59.8%.
Croatian: U zdravih ispitanika koji su uzimali jednokratnu dozu od 9 mg (3 x 3 mg) Votubia tableta za oralnu suspenziju u obliku suspenzije, obroci s visokim sadržajem masti smanjili su AUC za 11,7%, a vršnu koncentraciju u krvi Cmax za 59,8%.
English: • The co-administration of the PgP inhibitor, cyclosporine, enhances the exposure of everolimus in the brain cortex, which is consistent with the inhibition of PgP at the blood-brain barrier.
Croatian: • da istodobna primjena PgP inhibitora ciklosporina pojačava izloženost everolimusu u moždanoj kori, što se podudara s inhibicijom PgP-a na krvno-moždanoj barijeri.
English: At the time of the final analysis, the median duration of exposure among all such patients was 204.9 weeks (range: 8.1 to 253.7).
Croatian: U vrijeme završne analize, medijan trajanja izloženosti među svim takvim bolesnicima bio je 204,9 tjedana (raspon: 8,1 do 253,7).
English: Radiological evidence of serial SEGA growth was required for entry.
Croatian: Radiološki dokaz uzastopnog rasta SEGA-e je bio potreban za uključivanje u ispitivanje.
English: Median Cmin normalised to mg/m dose was lower for the younger age groups, indicating that everolimus clearance (normalised to body surface area) was higher in younger patients.
Croatian: Medijan Cmin normaliziranog prema dozi u mg/m bio je niži za mlađe dobne skupine, što ukazuje na to da je klirens everolimusa (normaliziran prema tjelesnoj površini) bio viši u mlađih bolesnika.
English: The effect is likely to be due to inhibition of intestinal CYP3A4 by everolimus.
Croatian: Učinak je vjerojatno posljedica inhibicije CYP3A4 u crijevu izazvane everolimusom.
English: In a population pharmacokinetic evaluation in cancer patients, no significant influence of age (27-85 years) on oral clearance of everolimus was detected.
Croatian: Procjena populacijske farmakokinetike u bolesnika oboljelih od raka nije pokazala značajan utjecaj dobi (27-85 godina) na oralni klirens everolimusa.
English: Key secondary endpoints in hierarchal order of testing included the absolute change in frequency of total seizure events per 24-hour EEG from baseline to week 24, time to SEGA progression, and skin lesion response rate.
Croatian: Ključne mjere sekundarnog ishoda uključivale su, prema redu važnosti, apsolutnu promjenu u učestalosti ukupnih događaja napadaja po 24-satnom EKG-u od početnih vrijednosti do 24. tjedna, vrijeme do progresije SEGA-e i stopu odgovora kožnih lezija.
English: High level of the hormone that triggers ovulation (blood luteinising hormone increased) Weight loss
Croatian: Visoka razina hormona koji potiče ovulaciju (povišeni luteinizirajući hormon u krvi) Gubitak tjelesne težine
English: Independent central review
Croatian: Neovisno centralno očitanje
English: The best overall SEGA response rate had increased to 57.7% (95% CI: 47.9, 67.0) at the final analysis.
Croatian: Najbolja ukupna stopa odgovora SEGA-e povećala se na 57,7% (95% CI: 47,9, 67,0) na završnoj analizi.
English: Time-averaged Cmin category
Croatian: Prosječna Cmin kategorija u zadanom vremenu
English: Votubia dispersible tablets are used to treat SEGA associated with TSC in adults and children for whom surgery is not appropriate.
Croatian: Votubia tablete za oralnu suspenziju se koriste u liječenju SEGA-e povezane s KTS-om u odraslih osoba i u djece za koje kirurško liječenje nije prikladno.
English: Do not use this medicine if the pack is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili postoje vidljivi znakovi neovlaštenog otvaranja.
English: If you experience certain side effects (see section 4) while you are taking Votubia, your doctor may lower your dose or stop treatment, either for a short time or permanently.
Croatian: Jave li se za trajanja liječenja Votubiom u Vas određene nuspojave (vidjeti dio 4.), Vaš liječnik može odlučiti sniziti dozu lijeka ili prekinuti liječenje, bilo privremeno, bilo trajno.
English: Votubia with food and drink Avoid grapefruit and grapefruit juice while you are on Votubia.
Croatian: Votubia s hranom i pićem Tijekom liječenja Votubiom izbjegavajte konzumaciju grejpa i soka od grejpa.
English: In the second study of 34 subjects with different impaired hepatic function compared to normal subjects, there was a 1.6-fold, 3.3-fold and 3.6-fold increase in exposure (i.e. AUC0-inf) for subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, respectively.
Croatian: U drugom ispitivanju provedenom u 34 ispitanika s različitim stupnjevima oštećenja funkcije jetre u usporedbi s normalnim ispitanicima, došlo je do povećanja od 1,6, 3,3 odnosno 3,6 puta u izloženosti (tj. AUC0-inf) u ispitanika s blagim (Child-Pugh A), umjerenim (Child-Pugh B), odnosno teškim (Child-Pugh C) oštećenjem funkcije jetre.
English: Overactivation of mTOR results in neuronal dysplasia, aberrant axonogenesis and dendrite formation, increased excitatory synaptic currents, reduced myelination, and disruption of the cortical laminar structure causing abnormalities in neuronal development and function.
Croatian: Prekomjerna aktivacija mTOR-a rezultira neuronskom displazijom, aberantnom aksonogenezom i stvaranjem dendrita, pojačanim strujama u ekscitatornim sinapsama, smanjenom mijelinizacijom te prekidom kortikalne laminarne strukture koja uzrokuje abnormanosti u razvoju i funkciji neurona.
English: Of the enrolled patients, 79.5% had bilateral SEGAs, 42.7% had ≥2 target SEGA lesions, 25.6% had inferior growth, 9.4% had evidence of deep parenchymal invasion, 6.8% had radiographic evidence of hydrocephalus, and 6.8% had undergone prior SEGA-related surgery.
Croatian: Od uključenih bolesnika, 79,5% imalo je bilateralne SEGA-e, 42,7% imalo je ≥2 ciljane SEGA lezije, 25,6% imalo je inferioran rast, u 9,4% bilo je dokaza postojanja dubinske parenhimalne invazije, u 6,8% bilo je radioloških dokaza postojanja hidrocefalusa, a 6,8% prethodno je imalo operaciju povezanu s liječenjem SEGA-e.
English: The stability of the ready to use suspension has been demonstrated for 30 minutes when using an oral syringe or 60 minutes when using a small glass.
Croatian: Suspenzija spremna za uporabu stabilna je 30 minuta kada se koristi štrcaljka za usta ili unutar 60 minuta kada se koristi mala čaša.
English: Push the plunger in until it touches the dispersible tablets.
Croatian: Gurnite klip prema unutra dok ne dotakne tablete za oralnu suspenziju.
English: <6 years n=33
Croatian: <6 godina n=33
English: After administration of the prepared suspension, approximately 5 ml of water and 4 ml of air should be drawn into the same syringe, and the contents should be swirled to suspend remaining particles.
Croatian: Nakon primjene pripremljene suspenzije, uvući otprilike 5 ml vode i 4 ml zraka u istu štrcaljku i lagano promućkati sadržaj kako bi se suspendirale preostale čestice.
English: Stomatitis is the most commonly reported adverse reaction in patients treated with Votubia (see sections 4.4 and 4.8).
Croatian: Stomatitis je najčešće prijavljena nuspojava u bolesnika liječenih Votubiom (vidjeti dijelove 4.4 i 4.8).
English: In clinical studies, everolimus has been associated with haemorrhage events.
Croatian: U kliničkim ispitivanjima everolimus je bio povezan s događajima krvarenja.
English: Grade 2 (≥1x10
Croatian: Stupanj 2 (≥1x10
English: Examples of live vaccines are: intranasal influenza, measles, mumps, rubella, oral polio, BCG (Bacillus Calmette-Guérin), yellow fever, varicella, and TY21a typhoid vaccines.
Croatian: Primjeri živih cjepiva su: intranazalno cjepivo protiv gripe, ospice, zaušnjaci, rubeola, oralni polio, BCG (Bacillus Calmette-Guérin), žuta groznica, vodene kozice i TY21a tifoidna cjepiva.
English: Hypersensitivity reactions manifested by symptoms including, but not limited to, anaphylaxis, dyspnoea, flushing, chest pain or angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus (see section 4.3).
Croatian: Reakcije preosjetljivosti koje se očituju simptomima koji uključuju, ali nisu ograničeni na anafilaksiju, dispneju, crvenilo, bol u prsima ili angioedem (tj. oticanje dišnih puteva ili jezika, s ili bez poremećaja disanja) zabilježene su pri primjeni everolimusa (vidjeti dio 4.3).
English: Blood lactate dehydrogenase increased, blood luteinising hormone increased, weight decreased
Croatian: Povišenje laktat dehidrogenaze u krvi, povišeni luteinizirajući hormon u krvi, smanjenje težine
English: If any tablets get stuck in the dry upper part of the oral syringe, gently tap the oral syringe until they fall down into the water.
Croatian: Ako se koja od tableta zaglavi u suhom, gornjem dijelu štrcaljke za usta, lagano kucnite prstom po štrcaljki za usta dok tablete ne padnu u vodu.
English: A total of 117 patients were randomised, 78 to Votubia and 39 to placebo.
Croatian: Ukupno je 117 bolesnika bilo randomizirano, 78 na primanje Votubie i 39 na primanje placeba.
English: In addition, serial radiological evidence of SEGA growth, presence of a new SEGA lesion ≥1 cm in longest diameter, or new or worsening hydrocephalus was required for entry.
Croatian: Uz navedeno, za uključenje su bili potrebni i uzastopni radiološki dokaz rasta SEGA-e, prisutnost nove SEGA lezije od ≥1 cm u najduljem promjeru te ili novi ili pogoršanje postojećeg hidrocefalusa.
English: Median time to angiomyolipoma progression was 11.4 months in the placebo arm and was not reached in the everolimus arm (HR 0.08; 95% CI: 0.02, 0.37; p<0.0001).
Croatian: Medijan vremena do progresije angiomiolipoma bio je 11,4 mjeseci u skupini koja je primala placebo i nije bio postignut u everolimus skupini (HR 0,08; 95% CI: 0,02, 0,37; p<0,0001).
English: The following side effects have been reported in patients taking everolimus for the treatment of conditions other than TSC:
Croatian: Sljedeće su nuspojave zabilježene u bolesnika koji su uzimali everolimus za liječenje bolesti koje nisu KTS:
English: If you are being treated for TSC with angiomyolipoma of the kidney, Votubia will only be prescribed for you by a doctor with experience in treating patients with TSC.
Croatian: Ako se liječite zbog KTS-a s angiomiolipomom bubrega, Votubiu će Vam propisati samo liječnik koji ima iskustva u liječenju bolesnika s KTS-om.
English: If concentrations are below 5 ng/ml, the daily dose may be increased by increments of 1 to 4 mg, checking the trough level and assessing tolerability before increasing the dose.
Croatian: Ako su koncentracije ispod 5 ng/ml, dnevna doza može se povećavati za po 1 do 4 mg, uz provjeravanje najnižih razina i procjenjivanje podnošljivosti prije povećavanja doze.
English: Grade 3 & 4 (<50x10
Croatian: Stupanj 3 & 4 (<50x10
English: The recommended dose is 10 mg of everolimus once daily.
Croatian: Preporučena doza je 10 mg everolimusa jedanput dnevno.
English: Everolimus whole blood trough concentrations should be assessed at least 1 week after commencing treatment.
Croatian: Najniže koncentracije everolimusa u punoj krvi potrebno je odrediti najmanje 1 tjedan nakon početka liječenja.
English: A total of 49 out of 137 patients (36%) aged <6 years had Grade 3/4 infections, compared to 53 out of 272 patients (19%) aged 6 to <18 years and 27 out of 203 patients (13%) aged ≥18 years.
Croatian: Ukupno je 49 od 137 bolesnika (36%) mlađih od 6 godina imalo infekcije stupnja 3/4, u usporedbi s 53 od 272 bolesnika (19%) u dobi od 6 do ispod 18 godina te 27 od 203 bolesnika (13%) u dobi od 18 i više godina.
English: Therefore, absorption and subsequent elimination of everolimus may be influenced by products that affect CYP3A4 and/or PgP.
Croatian: Prema tome, apsorpcija i posljedična eliminacija everolimusa mogu biti pod utjecajem lijekova koji utječu na CYP3A4 i/ili PgP.
English: Thirteen patients (46%) had a secondary smaller SEGA, including 12 in the contralateral ventricle.
Croatian: Trinaest bolesnika (46%) imalo je sekundarnu, veličinom manju SEGA-u, koja je u 12 bolesnika bila smještena u kontralateralnoj moždanoj klijetki.
English: In patients with TSC and refractory seizures, a conditional logistic regression analysis based on the core phase of Study CRAD001M2304 to estimate the probability of seizure response versus Time Normalized(TN)-Cmin stratified by age sub-group, indicated that a 2-fold increase in TN-Cmin was associated with a 2.172-fold increase (95% CI: 1.339, 3.524) in the odds for a seizure response over the observed TN-Cmin ranges of 0.97 ng/ml to 16.40 ng/ml.
Croatian: U bolesnika s KTS-om i refraktornim napadajima, uvjetna logistička regresijska analiza temeljena na osnovnoj fazi ispitivanja CRAD001M2304 za procjenu vjerojatnosti odgovora s obzirom na napadaje u odnosu na vremenski normaliziran(VN)-Cmin stratificiran prema dobnoj podskupini ukazala je na to da je dvostruko povećanje VN-Cmin bilo povezano s povećanjem od 2,172 puta (95% CI: 1,339; 3,524) u izgledima za odgovor s obzirom na napadaje u opaženim rasponima VN-Cmin od 0,97 ng/ml do 16,40 ng/ml.
English: At the time of the final analysis (4 years following the last patient randomisation), the median duration of exposure to everolimus was 204.1 weeks (range 2 to 278).
Croatian: U trenutku završne analize (4 godine nakon randomizacije zadnjeg bolesnika), medijan trajanja izloženosti everolimusu bio je 204,1 tjedan (raspon 2 do 278).
English: At baseline, 19.4% of patients had focal seizures with retained awareness (sensory previously confirmed on EEG or motor), 45.1% had focal seizures with impaired awareness (predominantly nonmotor), 69.1% had focal motor seizures (i.e. focal motor seizures with impaired awareness and/or secondary generalised seizures), and 1.6% had generalised onset seizures (previously confirmed by EEG).
Croatian: Na početku je 19,4% bolesnika imalo fokalne napadaje sa zadržavanjem svijesti (senzorne prethodno potvrđene na EEG-u ili motoričke), 45,1% imalo je fokalne napadaje sa smanjenom sviješću (uglavnom nemotoričke), 69,1% imalo je fokalne motoričke napadaje (npr. fokalne motoričke napadaje sa smanjenom svješću i/ili sekundarne generalizirane napadaje), a 1,6% je imalo generalizirane napadaje (prethodno potvrđene EEG-om).
English: The use of live vaccines should be avoided during treatment with Votubia.
Croatian: Primjenu živih cjepiva potrebno je izbjegavati tijekom liječenja Votubiom.
English: Votubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex (TSC).
Croatian: Votubia je indicirana kao pomoćna terapija za bolesnike u dobi od 2 i više godina čiji su refraktorni parcijalni napadaji, sa ili bez sekundarne generalizacije, povezani s kompleksom tuberozne skleroze (KTS).
English: Responders - n (%) Response rate 95% CI
Croatian: Osobe s odgovorom - n (%) Stopa odgovora 95% CI
English: Table 8 Change in primary SEGA volume over time
Croatian: Tablica 8 Promjena primarnoga volumena SEGA-e kroz vrijeme
English: • A rapid uptake of everolimus in the brain followed by a slow efflux.
Croatian: • na brzu apsorpciju everolimusa u mozgu nakon čega slijedi spori efluks
English: In patients with TSC, treatment with everolimus increases VEGF-A and decreases VEGF-D levels.
Croatian: U bolesnika s KTS-om, liječenje everolimusom povisuje razinu VEGF-A, a snižava razinu VEGF-D.
English: SEGA associated with TSC in adults and children for whom surgery is not appropriate.
Croatian: SEGA-e povezane s KTS-om, u odraslih osoba i u djece za koje kirurško liječenje nije prikladno.
English: The median age for the total population was 10.1 years (range: 2.2-56.3; 28.4% <6 years, 30.9% 6 to <12 years, 22.4% 12 to <18 years and 18.3% >18 years).
Croatian: Medijan dobi za ukupnu populaciju bio je 10,1 godina (raspon: 2,2-56,3; 28,4% <6 godina, 30,9% 6 do <12 godina, 22,4% 12 do <18 godina i 18,3% >18 godina).
English: The potential for everolimus to cause infertility in male and female patients is unknown, however secondary amenorrhoea and associated luteinising hormone (LH)/follicle stimulating hormone (FSH) imbalance has been observed in female patients (see also section 5.3 for preclinical observations on the male and female reproductive systems).
Croatian: Nije poznato izaziva li everolimus u muških i ženskih bolesnika neplodnost, no u bolesnica je uočena sekundarna amenoreja i s njome povezana neravnoteža luteinizirajućeg hormona (LH) i hormona koji stimulira folikule (FSH) (vidjeti također dio 5.3 za pretklinička zapažanja na reproduktivni sustav muškaraca i žena).