FrancophonIA/ELRC3.0 huggingface dataset:
English: The patient must drink the suspension immediately after it is prepared.
Croatian: Bolesnik mora popiti suspenziju odmah nakon pripreme.
English: Menstruation disorders such as heavy periods (menorrhagia) or vaginal bleeding Trouble sleeping (insomnia)
Croatian: Menstrualni poremećaji kao što su obilne menstruacije (menoragija) ili vaginalno krvarenje
English: Everolimus is a substrate of CYP3A4, and also a substrate and moderate inhibitor of PgP.
Croatian: Everolimus je supstrat za CYP3A4, te također supstrat i umjereni inhibitor PgP.
English: Open the blister just before taking Votubia dispersible tablets.
Croatian: Blister otvorite neposredno prije uzimanja Votubia tableta za oralnu suspenziju.
English: Grade 2
Croatian: PRILOG II.
English: A population pharmacokinetic analysis including 111 patients with SEGA who ranged from 1.0 to 27.4 years (including 18 patients 1 to less than 3 years of age with BSA 0.42 m to 0.74 m 2) showed that BSA-normalised clearance is in general higher in younger patients.
Croatian: Analiza populacijske farmakokinetike koja obuhvaća 111 bolesnika sa SEGA-om u rasponu od 1,0 do 27,4 godine (uključujući 18 bolesnika u dobi od 1 godine do mlađe od 3 godine s PT-om 0,42 m do
English: Interrupt Votubia until symptoms resolve to Grade 1.
Croatian: Stupanj 3 Prekinuti primjenu Votubie dok simptomi ne dođu do stupnja ≤1.
English: Different strengths of Votubia dispersible tablets can be combined to attain the desired dose.
Croatian: Različite jačine Votubia tableta za oralnu suspenziju mogu se kombinirati da bi se postigla željena doza.
English: Further dose reduction may be required to manage adverse reactions (see sections 4.2 and 4.4).
Croatian: U cilju zbrinjavanja nuspojava, dozu će možda trebati dodatno sniziti (vidjeti dio 4.2 i 4.4).
English: Based on analysis of population pharmacokinetics, oral clearance (CL/F) is on average 20% higher in black transplant patients.
Croatian: Oralni klirens u crnaca s presatkom (CL/F) je u prosjeku 20% viši na temelju analize populacijske farmakokinetike.
English: Month 12 n=26
Croatian: 12. mjesec n=26
English: Temporary dose interruption until recovery to Grade 2 (≥1x10
Croatian: Privremeni prekid primjene do oporavka do stupnja 2 (≥1x10
English: Caregivers are advised to avoid contact with suspensions of Votubia dispersible tablets.
Croatian: Njegovateljima se savjetuje da izbjegavaju kontakt sa suspenzijom Votubia tableta za oralnu suspenziju.
English: Odds ratio >1 favours everolimus arm.
Croatian: Omjer izgleda >1 govori u prilog skupini s everolimusom.
English: Place them into the barrel of the oral syringe straight away.
Croatian: Zatim ih odmah stavite u trup štrcaljke za usta.
English: If not administered within 30 minutes of preparation when using an oral syringe or 60 minutes when using a small glass, the suspension must be discarded and a new suspension must be prepared (see section 6.3).
Croatian: Ako se ne popije unutar 30 minuta od pripreme kada se koristi štrcaljka za usta ili unutar 60 minuta kada se koristi mala čaša, suspenziju se mora baciti i mora se pripremiti novu suspenziju (vidjeti dio 6.3).
English: Talk to your doctor if you wish to have children.
Croatian: Ukoliko želite imati djecu, porazgovarajte sa svojim liječnikom.
English: Fever, sore throat or mouth ulcers due to infections (signs of low level of white blood cells, also known as leucopenia, lymphopenia, neutropenia) Spontaneous bleeding or bruising (signs of low level of platelets, also known as thrombocytopenia)
Croatian: Vrućica, grlobolja ili ranice u ustima zbog infekcija (znakovi niske razine bijelih krvnih stanica, poznate i pod nazivima leukopenija, limfopenija, neutropenija) Spontano krvarenje ili pojava modrica (znakovi niske razine krvnih pločica, poznate i pod nazivom trombocitopenija)
English: Special information for caregivers
Croatian: Posebne upute za njegovatelje
English: Temporary dose interruption.
Croatian: Stupanj 3 Privremeni prekid primjene.
English: The safety, tolerability and pharmacokinetics of Votubia were evaluated in two single oral dose studies of Votubia tablets in 8 and 34 adult subjects with impaired hepatic function relative to subjects with normal hepatic function.
Croatian: Votubie ocjenjivane su u dva ispitivanja jednokratne peroralne doze tableta Votubia provedena u 8 odnosno 34 odrasla ispitanika s oštećenom funkcijom jetre u odnosu na ispitanike s normalnom funkcijom jetre.
English: EXIST-2 (study CRAD001M2302), a randomised, controlled phase III study was conducted to evaluate the efficacy and safety of Votubia in patients with TSC plus renal angiomyolipoma.
Croatian: EXIST-2 (ispitivanje CRAD001M2302), randomizirano, kontrolirano ispitivanje faze III bilo je provedeno kako bi se ocijenila djelotvornost i sigurnost primjene Votubie u bolesnika s KTS-om i angiomiolipomom bubrega.
English: In a relative bioavailability study, AUC0-inf of 5 x 1 mg everolimus tablets when administered as suspension in water was equivalent to 5 x 1 mg everolimus tablets administered as intact tablets, and Cmax of 5 x 1 mg everolimus tablets in suspension was 72% of 5 x 1 mg intact everolimus tablets.
Croatian: U ispitivanju relativne bioraspoloživosti, AUC0-inf tableta everolimusa 5 x 1 mg primijenjenih kao suspenzija u vodi bio je ekvivalentan onome tableta everolimusa 5 x 1 mg primijenjenih kao cjelovite tablete, a Cmax tableta everolimusa 5 x 1 mg u suspenziji bio je 72% onoga cjelovitih tableta everolimusa 5 x 1 mg.
English: Infections and infestations Very common Nasopharyngitis, upper respiratory tract infection, pneumonia a, urinary tract infection, sinusitis, pharyngitis
Croatian: Nazofaringitis, infekcija gornjeg dijela dišnog sustava, pneumonija a, infekcija mokraćnog sustava, sinusitis, faringitis
English: Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported in patients treated with Votubia (see section 4.8).
Croatian: Sniženje vrijednosti hemoglobina, broja limfocita, neutrofila i trombocita zabilježeno je u bolesnika liječenih Votubiom (vidjeti dio 4.8).
English: Therefore caregivers are advised to avoid contact with the suspension.
Croatian: Njegovateljima se stoga savjetuje da izbjegavaju kontakt sa suspenzijom lijeka.
English: The prescribed dose of Votubia dispersible tablets should be placed in a 10 ml oral dosing syringe graduated in 1 ml increments.
Croatian: Staviti propisanu dozu Votubia tableta za oralnu suspenziju u štrcaljku za usta od 10 ml s oznakama za doziranje u razmaku od 1 ml.
English: Re-insert the plunger into the barrel of the oral syringe.
Croatian: Ponovno umetnite klip u trup štrcaljke za usta.
English: In a bioequivalence study, AUC0-inf of the 5 mg dispersible tablet when administered as suspension in water was equivalent to 5 x 1 mg intact everolimus tablets, and Cmax of the 5 mg dispersible tablet in suspension was 64% of 5 x 1 mg intact everolimus tablets.
Croatian: U ispitivanju bioekvivalencije, AUC0-inf tableta za oralnu suspenziju od 5 mg primijenjenih kao suspenzija u vodi bio je ekvivalentan cjelovitim tabletama everolimusa 5 x 1 mg, a Cmax tableta za oralnu suspenziju od 5 mg bio je 64% onoga za cjelovite tablete everlimusa 5 x 1 mg.
English: Remove the dispersible tablets from the blister.
Croatian: Izvadite tablete za oralnu suspenziju iz blistera.
English: Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (see section 4.4).
Croatian: Istodobna primjena inhibitora angiotenzin konvertirajućeg enzima (ACE) Bolesnici koji istodobno uzimaju terapiju ACE inhibitorima (npr. ramipril) mogu imati povećan rizik od angioedema (vidjeti dio 4.4).
English: Swollen, bleeding gums (signs of gum inflammation, also known as gingivitis) Skin inflammation (cellulitis)
Croatian: Otečeno zubno meso koje krvari (znakovi upale zubnog mesa, poznate i pod nazivom gingivitis) Upala kože (celulitis)
English: Consistent results were found for the supportive analysis of the median percentage reduction from baseline in seizure frequency (other primary endpoint): 29.3% (95% CI: 18.8, 41.9) in the Votubia LT arm, 39.6% (95% CI: 35.0, 48.7) in the Votubia HT arm and 14.9% (95% CI: 0.1, 21.7) in the placebo arm.
Croatian: Konzistentni rezultati su nađeni kod suportivne analize medijana postotnog smanjenja od početne vrijednosti u učestalosti napadaja (druga mjera primarnog ishoda): 29,3% (95% CI: 18,8; 41,9) u skupini Votubia DN, 39,6% (95% CI: 35,0; 48,7) u skupini Votubia GN te 14,9% (95% CI: 0,1; 21,7) u placebo skupini.
English: It may reduce the size of brain tumours called subependymal giant cell astrocytomas (SEGA) which are also caused by TSC.
Croatian: Može smanjiti veličinu tumora mozga koji se zovu subependimalni astrocitomi orijaških stanica (SEGA; engl.
English: The seizure-free rate (the proportion of patients who became seizure-free during the maintenance period of the core phase) was 5.1% (95% CI: 1.9, 10.8) and 3.8% (95% CI: 1.3, 8.7) in the Votubia LT and HT arms, respectively, versus 0.8% (95% CI: 0.0, 4.6) of patients in the placebo arm.
Croatian: Stopa izostanka napadaja (udio bolesnika u kojih nije bilo napadaja tijekom faze održavanja u osnovnoj fazi) bila je 5,1% (95% CI: 1,9; 10,8) odnosno 3,8% (95% CI: 1,3; 8,7) u skupinama Votubia DN, odnosno GN, u odnosu na 0,8% (95% CI: 0,0; 4,6) bolesnika u placebo skupini.
English: 25% resp. 25 to <50
Croatian: 25% osoba s odgovorom 25 do <50
English: If you are being treated for SEGA associated with TSC, Votubia will only be prescribed by a doctor with experience in treating patients with SEGA and with access to blood tests which will measure how much Votubia is in your blood.
Croatian: Ako se liječite zbog SEGA-e povezane s KTS-om, Votubiu će propisati samo liječnik s iskustvom u liječenju oboljelih od SEGA-e te koji ima dostupne krvne pretrage koje mjere količinu Votubie u Vašoj krvi.
English: The other ingredients are butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and lactose anhydrous.
Croatian: Drugi sastojci su butilhidroksitoluen (E321), magnezijev stearat, laktoza hidrat, hipromeloza, krospovidon tipa A, bezvodna laktoza.
English: • EXIST-3 (CRAD001M2304): This was a randomised, double-blind, controlled, phase III trial comparing adjunctive treatment of low and high everolimus exposure (low trough [LT] range of 3-7 ng/ml [n=117] and high trough [HT] range of 9-15 ng/ml [n=130]) versus placebo (n=119), in patients with TSC and refractory partial-onset seizures receiving 1 to 3 antiepileptics.
Croatian: • EXIST-3 (CRAD001M2304): Ovo je bilo randomizirano, dvostruko slijepo, kontrolirano ispitivanje faze III u kojem se uspoređivala pomoćna terapija s niskom i visokom izloženošću everolimusu (donji najniži [DN] raspon od 3-7 ng/ml [n=117] i gornji najniži [GN] raspon od 9-15 ng/ml [n=130]) u odnosu na placebo (n=119), u bolesnika s KTS-om i refraktornim parcijalnim napadajima koji su primali 1 do 3 antiepileptika.
English: Month 24 n=24
Croatian: 24. mjesec n=24
English: Phase III study in patients with TSC and refractory seizures EXIST-3 (Study CRAD001M2304), a randomised, double-blind, multicentre, three-arm, parallel-group phase III study of Votubia versus placebo as adjunctive therapy was conducted in TSC patients with refractory partial-onset seizures.
Croatian: Ispitivanje faze III u bolesnika s KTS-om i refraktornim napadajima EXIST-3 (Ispitivanje CRAD001M2304), randomizirano, dvostruko slijepo, multicentrično ispitivanje faze III s tri paralelne skupine u kojem se ispitivala Votubia u odnosu na placebo kao pomoćna terapija, provedeno je u bolesnika s KTS-om i refraktornim parcijalnim napadajima.
English: The incidence of skeletal variations and malformations (e.g. sternal cleft) was increased at 0.3 and 0.9 mg/kg.
Croatian: Pri primjeni doza od 0,3 i 0,9 mg/kg porasla je incidencija skeletnih varijacija i malformacija (npr. rascjepa prsne kosti).
English: 50% resp. 50 to <75
Croatian: 50% osoba s odgovorom 50 do <75
English: Irritability
Croatian: Razdražljivost
English: No serious cases of renal haemorrhage were reported in the TSC setting.
Croatian: Nisu prijavljeni ozbiljni slučajevi krvarenja bubrega u osoba s KTS-om.
English: Table 5 EXIST-3 - Seizure frequency response rate (primary endpoint)
Croatian: Tablica 5 EXIST-3 - Stopa odgovora s obzirom na učestalost napadaja (mjera primarnog ishoda)
English: Table 1 Votubia dose adjustment recommendations
Croatian: Tablica 1 Preporuke za prilagođavanje doze Votubie
English: Month 48 n=24
Croatian: 48. mjesec n=24
English: The entire contents of the syringe should be administered.
Croatian: Primijeniti cjelokupni sadržaj iz štrcaljke.
English: Stomatitis, including mouth ulcerations and oral mucositis, is the most commonly reported adverse reaction in patients treated with Votubia (see section 4.8).
Croatian: Stomatitis, koji uključuje ulceracije u usnoj šupljini i oralni mukozitis, najčešće je zabilježena nuspojava u bolesnika liječenih Votubiom (vidjeti dio 4.8).
English: Recommendations concerning co-administration
Croatian: Preporuke za istodobnu primjenu
English: If the moderate inhibitor is discontinued, consider a washout period of at least 2 to 3 days (average elimination time for most commonly used moderate inhibitors) before the Votubia dose is returned to the dose used prior to initiation of the coadministration.
Croatian: Ako se prekine primjena umjerenog inhibitora, potrebno je uzeti u obzir period ispiranja organizma od najmanje 2 do 3 dana (prosječno vrijeme eliminacije za najčešće korištene umjerene inhibitore) prije povratka doze Votubie na dozu primjenjivanu prije početka istodobne primjene.
English: Patients with SEGA associated with TSC:
Croatian: Bolesnici sa SEGA-om povezanom s KTS-om:
English: Decreased exposure expected.
Croatian: Očekuje se jako smanjena izloženost.
English: AUC ↑4.4-fold (range 2.0-12.6) Cmax ↑2.0-fold (range 0.9-3.5)
Croatian: AUC ↑4,4-puta (raspon 2,0-12,6) Cmax ↑2,0-puta (raspon 0,9-3,5)
English: Month 6 n=27
Croatian: 6. mjesec n=27
English: Dosing recommendations for paediatric patients with seizures are consistent with those for the adult population, except for patients in the range from 2 years to less than 6 years of age, and those with hepatic impairment (see section “Hepatic impairment” below and section 5.2).
Croatian: Preporuke za doziranje kod pedijatrijskih bolesnika s napadajima u skladu su s onima za odraslu populaciju, osim za bolesnike u dobi od 2 godine do mlađe od 6 godina te za one s oštećenjem funkcije jetre (vidjeti dio „Oštećenje funkcije jetre“ u nastavku i dio 5.2).
English: Angiomyolipoma response rate 95% CI
Croatian: Stopa odgovora angiomiolipoma 95% CI
English: Grade 3
Croatian: PRILOG III.
English: Table 2 Votubia dose adjustment recommendations
Croatian: Tablica 2 Preporuke za prilagođavanje doze Votubie
English: The primary efficacy endpoint was SEGA response rate based on independent central radiology review.
Croatian: Mjera primarnog ishoda za djelotvornost bila je stopa odgovora SEGA-e prema neovisnom centralnom radiološkom očitanju.
English: Anaemia, neutropenia, leucopenia, thrombocytopenia, lymphopenia Immune system disorders
Croatian: Anemija, neutropenija, leukopenija, trombocitopenija, limfopenija Poremećaji imunološkog sustava Često
English: If you do not use it within 60 minutes, throw it away and prepare a new suspension.
Croatian: Ako ju ne popijete unutar 60 minuta, bacite ju i pripremite novu suspenziju.
English: Table 6 EXIST-1 - SEGA response
Croatian: Tablica 6 EXIST-1 - odgovor SEGA-e
English: • The most you can take at one time using the oral syringe or small glass is 10 mg, using a maximum of 5 dispersible tablets.
Croatian: • Najveća količina koju možete uzeti odjednom pomoću štrcaljke za usta ili male čaše je 10 mg,
English: Not evaluable
Croatian: Ne može se ocijeniti
English: Nose bleeds (epistaxis)
Croatian: Krvarenje iz nosa (epistaksa)
English: Dosing should be titrated to attain trough concentrations of 5 to 15 ng/ml.
Croatian: Dozu je potrebno titrirati tako da se postignu najniže koncentracije od 5 do 15 ng/ml.
English: Two fatal cases due to infection were reported in 409 patients aged <18 years receiving everolimus.
Croatian: Između 409 bolesnika mlađih od 18 godina koji su primali everolimus, zabilježena su dva smrtna slučaja uzrokovana infekcijom.
English: Response rate
Croatian: Način primjene
English: If treatment with the inducer is discontinued, consider a washout period of at least 3 to 5 days (reasonable time for significant enzyme de-induction) before the Votubia dose is returned to the dose used prior to initiation of the co-administration (see also Therapeutic drug monitoring in section 4.2).
Croatian: Ako se prekine liječenje induktorom, potrebno je uzeti u obzir period ispiranja organizma od najmanje 3 do 5 dana (prihvatljivo vrijeme za značajno smanjenje indukcije enzima) prije povratka doze Votubie na dozu primjenjivanu prije početka istodobne primjene (vidjeti također Praćenje terapijskih učinaka lijeka u dijelu 4.2).
English: For children with SEGA, it is important to have a discussion with the doctor about the childhood vaccination program before treatment with Votubia.
Croatian: Kada je riječ o djeci oboljeloj od SEGA-e, važno je razgovarati s liječnikom o ciklusu cijepljenja u dječjoj dobi prije započinjanja liječenja Votubiom. ako imate visoki kolesterol.
English: Trough concentrations should be assessed at least 1 week after the initial dose, after any change in dose or pharmaceutical form, after initiation of or change in co-administration of CYP3A4 inhibitors (see sections 4.4 and 4.5) or after any change in hepatic status (Child-Pugh) (see section “Hepatic impairment” below and section 5.2).
Croatian: Najniže koncentracije lijeka u krvi potrebno je odrediti najmanje 1 tjedan nakon davanja početne doze, nakon svake promjene visine doze ili farmaceutskog oblika, nakon uvođenja ili promjene istodobno primjenjivanih CYP3A4 inhibitora (vidjeti dijelove 4.4 i 4.5) ili nakon bilo koje promjene u stanju jetre (Child-Pugh) (vidjeti dio „Oštećenje funkcije jetre“ u nastavku i dio 5.2).
English: You must drink the suspension immediately after preparing it.
Croatian: Suspenziju morate popiti odmah nakon pripreme.
English: Mix the medicine by slowly turning the oral syringe upside down and back again five times just before using the dose.
Croatian: Neposredno prije primjene promiješajte lijek lagano okrećući štrcaljku za usta gore-dolje pet puta.
English: The dispersible tablets must not be broken or crushed.
Croatian: Tablete za oralnu suspenziju se ne smiju lomiti ili drobiti.
English: How to store Votubia
Croatian: Kako čuvati Votubiu
English: At the primary analysis, skin lesion response rates of 26.0% (95% CI: 16.6, 37.2) for the Votubia arm and 0% (95% CI: 0.0, 9.5) for the placebo arm were observed (p=0.0002).
Croatian: U primarnoj analizi, zabilježene su stope odgovora kožnih lezija od 26,0% (95% CI: 16,6, 37,2) za skupinu koja je primala Votubiu i 0% (95% CI: 0,0, 9,5) za placebo skupinu (p=0,0002).
English: Votubia may also: cause mouth sores (oral ulcerations).
Croatian: Votubia također može: uzrokovati ranice u ustima (oralne ulceracije). oslabiti Vaš imunološki sustav.
English: Votubia is not recommended for patients <18 years of age with SEGA and hepatic impairment.
Croatian: Votubia se ne preporučuje za bolesnike mlađe od 18 godina sa SEGA-om i oštećenjem funkcije jetre.
English: AUC ↑15.3-fold (range 11.2-22.5) Cmax ↑4.1-fold (range 2.6-7.0)
Croatian: AUC ↑15,3-puta (raspon 11,2-22,5) Cmax ↑4,1-puta (raspon 2,6-7,0)
English: AUC ↑2.7-fold (range 1.5-4.7) Cmax ↑1.8-fold (range 1.3-2.6)
Croatian: AUC ↑2,7-puta (raspon 1,5-4,7) Cmax ↑1,8-puta (raspon 1,3-2,6)
English: Dose monitoring
Croatian: Praćenje doze
English: Month 36 n=23
Croatian: 36. mjesec n=23
English: A homogeneous and consistent everolimus effect was observed across all subgroups evaluated for the primary efficacy endpoints by: age categories (Table 6), gender, race and ethnicity, seizure types,
Croatian: Homogeni i dosljedni učinak everolimusa uočen je u svim podskupinama kod kojih su se ocjenjivale mjere primarnog ishoda djelotvornosti prema: dobnim kategorijama (Tablica 6), spolu, rasi i etničkom podrijetlu, vrstama napadaja, učestalosti napadaja na početku, broju i nazivu istodobno primjenjivanih antiepileptika te obilježjima KTS-a (angiomiolipom, SEGA, status kortikalnih tubera).
English: Butylated hydroxytoluene (E321) Magnesium stearate Lactose monohydrate Hypromellose
Croatian: 6.1 Popis pomoćnih tvari butilhidroksitoluen (E321) magnezijev stearat laktoza hidrat hipromeloza krospovidon tipa
English: Put the filled oral syringe in the clean, empty glass with the tip pointing up.
Croatian: Stavite napunjenu štrcaljku za usta s vrhom okrenutim prema gore u čistu i praznu čašu.
English: 10 x 1 tablets 30 x 1 tablets 100 x 1 tablets
Croatian: 10 x 1 tableta 30 x 1 tableta 100 x 1 tableta
English: Month 60 n=23
Croatian: 60. mjesec n=23
English: A higher starting dose of 7 mg/m is therefore recommended for patients 1 to less than 3 years of age with SEGA (see section 4.2).
Croatian: Stoga se viša početna doza od 7 mg/m preporučuje za bolesnike u dobi od 1 godine do mlađe od 3 godine sa SEGA-om
English: Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)
Croatian: Subependimalni astrocitom orijaških stanica (SEGA) povezan s kompleksom tuberozne skleroze (KTS)
English: Excipient with known effect Each tablet contains 297 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 297 mg laktoze.
English: Excipient with known effect Each tablet contains 74 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 74 mg laktoze.
English: Primary SEGA volume was reduced at month 6 compared to baseline (p<0.001 [see Table 8]).
Croatian: Nakon 6 mjeseci liječenja, volumen primarne SEGA-e bio je manji od početnog (p<0,001 [vidjeti Tablicu 8.]).
English: If all potent inducers are discontinued, consider a washout period of at least 3 to 5 days (reasonable time for significant enzyme de-induction) before the Votubia dose is returned to the dose used prior to initiation of the co-administration.
Croatian: Ako se prekine primjena svih potentnih induktora, potrebno je uzeti u obzir period ispiranja organizma od najmanje 3 do 5 dana (prihvatljivo vrijeme za značajno smanjenje indukcije enzima) prije povratka doze Votubie na dozu primjenjivanu prije početka istodobne primjene.
English: Primary SEGA volume was reduced at month 6 compared to baseline (p<0.001 [see Table 7]).
Croatian: Nakon 6 mjeseci liječenja, volumen primarne SEGA-e bio je manji od početnog (p<0,001 [vidjeti Tablicu 7.]).
English: Mean CL/F of everolimus after 10 mg daily dose in patients with advanced solid tumours was 24.5 l/h.
Croatian: Nakon primjene dnevne doze od 10 mg, u bolesnika sa uznapredovalim solidnim tumorima srednja vrijednost CL/F everolimusa iznosila je 24,5 l/h.
English: A total of 10 mg of Votubia dispersible tablets per glass using a maximum of 5 dispersible tablets must not be exceeded.
Croatian: Paziti da se ne premaši doza od ukupno 10 mg Votubia tableta za oralnu suspenziju po čaši koristeći maksimalno 5 tableta za oralnu suspenziju.
English: Different strengths of Votubia tablets can be combined to attain the desired dose.
Croatian: Votubia tableta mogu se kombinirati da se postigne željena doza.
English: Hepatitis B reactivation has been observed in some patients taking everolimus.
Croatian: U nekih bolesnika liječenih everolimusom uočena je reaktivacija hepatitisa B.
English: Uncommon Blood follicle stimulating hormone increased a
Croatian: Manje često Povišeni folikulostimulirajući hormon u krvi a
English: Votubia 10 mg tablets
Croatian: Votubia 10 mg tablete
English: • EXIST-1 (CRAD001M2301): This was a randomised, double-blind, controlled, phase III trial of everolimus (n=78) versus placebo (n=39) in patients with TSC who have SEGA, irrespective of age.
Croatian: • EXIST-1 (CRAD001M2301): Ovo je bilo randomizirano, dvostruko slijepo, kontrolirano ispitivanje faze III u kojem se ispitivao everolimus (n=78) u usporedbi s placebom (n=39) u bolesnika s KTS-om oboljelih od SEGA-e, bez obzira na dob.
English: Table 4 EXIST-2 - Angiomyolipoma response
Croatian: Tablica 4 EXIST-2 - Odgovor angiomiolipoma