FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients ≥18 years of age:
Croatian: Bolesnici mlađi od 18 godina:
English: D-90429 Nuremberg
Croatian: D-90429 Nürnberg
English: The use of corticosteroids may be indicated.
Croatian: Možda će biti indicirana primjena kortikosteroida.
English: Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor.
Croatian: Everolimus je selektivni mTOR (engl. mammalian target of rapamycin) inhibitor.
English: However, in rats, everolimus and/or its metabolites readily pass into the milk (see section 5.3).
Croatian: Međutim, u štakora se everolimus i/ili njegovi metaboliti lako izlučuju u mlijeko (vidjeti dio 5.3).
English: What you need to know before you take Votubia
Croatian: Što morate znati prije nego počnete uzimati Votubiu
English: • difficulty breathing or swallowing
Croatian: • otežano disanje ili gutanje
English: The mean elimination half-life of everolimus is approximately 30 hours.
Croatian: Srednja vrijednost poluvremena eliminacije everolimusa iznosi približno 30 sati.
English: Dosing is individualised based on Body Surface Area (BSA) using the Dubois formula, where weight (W) is in kilograms and height (H) is in centimetres:
Croatian: Doza se određuje pojedinačno na temelju površine tijela (PT) korištenjem Dubois formule, pri čemu se tjelesna težina (T) izražava u kilogramima, a visina (V) u centimetrima:
English: • The radioactive metabolites of [3H]everolimus do not significantly cross the blood-brain barrier.
Croatian: • da radioaktivni metaboliti [3H]everolimusa značajno ne prelaze krvno-moždanu barijeru
English: Angiomyolipoma progressions were observed in 14.3% of the patients.
Croatian: Progresija angiomiolipoma uočena je u 14,3% bolesnika.
English: c p-values computed from the Cochran-Mantel-Haenszel test stratified by age subgroup d
Croatian: c p-vrijednosti izračunate iz Cochran-Mantel-Haenszelovog testa stratificiranog prema dobnoj podskupini d
English: Push the plunger up slowly to remove most of the air (it is okay for a small amount of air to remain around the tip).
Croatian: Polako potisnite klip prema gore kako biste istisnuli većinu zraka (u redu je ako manja količina zraka ostane oko vrha).
English: Name and address of the manufacturer responsible for batch release Novartis Pharma GmbH
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Novartis Pharma GmbH
English: Everolimus is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti everolimus tijekom trudnoće i u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Analysis of the first key secondary endpoint, change in seizure frequency, was inconclusive; thus, despite the fact that positive results were observed for the two subsequent secondary endpoints (time to SEGA progression and skin lesion response rate), they could not be declared formally statistically significant.
Croatian: Analiza prve ključne mjere sekundarnog ishoda, promjene u učestalosti napadaja, nije dala definitivne rezultate; stoga, usprkos uočenim pozitivnim rezultatima za iduće dvije mjere sekundarnog ishoda (vrijeme do progresije SEGA-e i stopa odgovora kožnih lezija), nije bilo moguće te rezultate proglasiti statistički značajnima.
English: Besides pathological changes in brain tissue (such as cortical tubers) which may cause seizures, the mTOR pathway is also implicated in the pathogenesis of epilepsy in TSC.
Croatian: Osim patoloških promjena u tkivu mozga (kao što su kortikalni tuberi) koji mogu izazvati napadaje, mTOR put je također uključen u patogenezu epilepsije kod KTS-a.
English: Do not take Votubia 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 Votubiu ako ste alergični na everolimus, njemu srodne tvari poput sirolimusa ili temsirolimusa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: For further details on handling, see section 6.6.
Croatian: Za daljnje detalje o rukovanju lijekom vidjeti dio 6.6.
English: In the absence of clinical data, the possibility of an additive effect on adverse events cannot be excluded when everolimus is given in conjunction with a ketogenic diet.
Croatian: U odsustvu kliničkih podataka, mogućnost dodatnog učinka na štetne događaje se ne može isključiti kada se everolimus daje u kombinaciji s ketogenom dijetom.
English: New everolimus dose = current dose x (target concentration / current concentration)
Croatian: Nova doza everolimusa = sadašnja doza x (ciljana koncentracija / sadašnja koncentracija)
English: If you experience any of these side effects, tell your doctor immediately as this might have lifethreatening consequences.
Croatian: Ako osjetite bilo koju od nuspojava, odmah obavijestite svog liječnika, jer posljedice mogu biti opasne po život.
English: Individualised dose titration can be based on simple proportion:
Croatian: Titriranje doze za pojedinog bolesnika može se temeljiti na jednostavnom omjeru:
English: Other possible side effects of Votubia include:
Croatian: Druge moguće nuspojave Votubie uključuju:
English: Symptoms may include swelling and/or pain in one of your legs, usually in the calf, redness or warm skin in the affected area
Croatian: Simptomi mogu uključivati oticanje i/ili bol u jednoj od Vaših nogu, obično u listu, crvenilo ili toplu kožu na zahvaćenom dijelu
English: Votubia may have a minor or moderate influence on the ability to drive and use machines.
Croatian: Votubia malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: All patients receiving at least one dose of everolimus were followed until drug discontinuation or study completion.
Croatian: Svi bolesnici koji su primili najmanje jednu dozu everolimusa bili su praćeni do prekida uzimanja lijeka ili dovršetka ispitivanja.
English: Physicians and patients should be aware of the increased risk of infection with Votubia.
Croatian: Liječnici i bolesnici moraju biti svjesni povećanog rizika za nastanak infekcije tijekom primjene Votubie.
English: The adverse events considered to be associated with the use of Votubia (adverse reactions), based upon the review and medical assessment of all adverse events reported in the above studies, are described below.
Croatian: Štetni događaji za koje se smatra da su povezani s primjenom Votubie (nuspojave), temeljem pregleda i medicinske procjene svih štetnih događaja prijavljenih u gore navedenim ispitivanjima, opisani su ispod.
English: Votubia may affect the way some other medicines work.
Croatian: Votubia može utjecati na mehanizam djelovanja nekih drugih lijekova.
English: Votubia must be administered orally once daily at the same time every day, consistently either with or without food (see section 5.2).
Croatian: Votubiu je potrebno uzimati peroralno, jednom dnevno, svaki dan u isto vrijeme, dosljedno ili uz obrok ili bez obroka (vidjeti dio 5.2).
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Prikaz učestalosti nuspojava definiran je na sljedeći način: vrlo često (≥1/10); često (≥ /100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you had allergic reactions before, please ask your doctor for advice.
Croatian: Ako ste ranije imali alergijske reakcije, potražite savjet od svog liječnika.
English: Therefore, you may be at risk of getting an infection while you are taking Votubia.
Croatian: Zbog toga možete biti u opasnosti od infekcije dok uzimate Votubiu.
English: Consistently take only the tablets or only the dispersible tablets, and never a combination of both.
Croatian: Dosljedno uzimajte samo tablete ili samo tablete za oralnu suspenziju, nikad kombinaciju obje.
English: If a dose is missed, the patient should not take an additional dose, but take the usual prescribed next dose.
Croatian: U slučaju propuštene doze, bolesnik ne smije uzeti dodatnu dozu, već treba uzeti uobičajeno propisanu sljedeću dozu.
English: • swelling of the face, lips, tongue or throat (signs of angioedema)
Croatian: • oticanje lica, usnica, jezika ili vrata (znakovi angioedema)
English: Votubia tablets are used to treat:
Croatian: Votubia tablete se koriste u liječenju:
English: Best overall angiomyolipoma response - % Response
Croatian: Najbolji ukupni odgovor angiomiolipoma - % Odgovor
English: Odds ratio and its 95% CI obtained using logistic regression stratified by age subgroup.
Croatian: Omjer izgleda i pripadajući 95% CI dobiveni pomoću logističke regresije stratificirane prema dobnoj podskupini.
English: This dose of Votubia is predicted to adjust the AUC to the range observed without inducers.
Croatian: Predviđa se da će ta doza Votubie prilagoditi AUC na raspon uočen bez induktora.
English: Therefore, women taking everolimus should not breast-feed during treatment and for 2 weeks after the last dose.
Croatian: Stoga žene koje uzimaju everolimus ne smiju dojiti tijekom liječenja te još 2 tjedna nakon posljednje doze.
English: Itraconazole, posaconazole, voriconazole
Croatian: Itrakonazol, posakonazol, vorikonazol
English: Votubia is available in two pharmaceutical forms: tablets and dispersible tablets.
Croatian: Votubia je dostupna u dva farmaceutska oblika: tablete i tablete za oralnu suspenziju.
English: Steady-state was achieved within 2 weeks.
Croatian: Stanje dinamičke ravnoteže postignuto je unutar 2 tjedna.
English: Only use water (drinkable tap water or non-sparkling bottled water) to prepare the oral suspension.
Croatian: Koristite samo vodu (vodu za piće iz slavine ili negaziranu buteljiranu vodu) za pripremu oralne suspenzije.
English: The incidence of Grade 1 stomatitis was 18.8% (n=16/85) and no cases of Grade 3 or 4 stomatitis were reported.
Croatian: Incidencija stomatitisa stupnja 1 bila je 18,8% (n=16/85), a nije bio prijavljen nijedan slučaj stomatitisa stupnja 3 ili 4.
English: Take Votubia tablets once a day.
Croatian: Uzimajte Votubia tablete jednom dnevno.
English: 9/l) and no fever.
Croatian: 9/l) i povlačenja vrućice.
English: In the final analysis, reduction in angiomyolipoma volume improved with longer term treatment with Votubia.
Croatian: U završnoj analizi, smanjenje volumena angiomiolipoma se poboljšalo s duljim trajanjem liječenja Votubiom.
English: Instructions for patients or caregivers preparing the suspension using a small glass:
Croatian: Upute za bolesnike ili njegovatelje koji pripremaju suspeziju korištenjem male čaše:
English: No specific excretion studies have been undertaken in cancer patients; however, data are available from the studies in transplant patients.
Croatian: U bolesnika oboljelih od raka nisu provedena posebna ispitivanja eliminacije, no postoje podaci iz ispitivanja provedenih na transplantiranim bolesnicima.
English: Everolimus crossed the placenta and was toxic to the foetus.
Croatian: Everolimus je prošao placentarnu barijeru i bio je toksičan za plod.
English: No data are available (see sections 5.1 and 5.2).
Croatian: Nema dostupnih podataka (vidjeti dijelove 5.1 i 5.2).
English: Everolimus is not considered dialysable to any relevant degree (less than 10% was removed within 6 hours of haemodialysis).
Croatian: Ne smatra se da se everolimus može dijalizirati do nekog značajnog stupnja (kroz 6 sati hemodijalize uklonjeno je manje od 10% lijeka).
English: Studies in animals have shown reproductive toxicity effects including embryotoxicity and foetotoxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, uključujući embriotoksičnost i fetotoksičnost (vidjeti dio 5.3).
English: • Scissors to open the blister
Croatian: • Škare za otvaranje blistera
English: More frequent monitoring is recommended when Votubia is co-administered with other medicinal products that may induce hyperglycaemia.
Croatian: Preporučuje se češće praćenje kada se Votubia istodobno primjenjuje s drugim lijekovima koji mogu inducirati hiperglikemiju.
English: The non-clinical 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: These instructions are for taking a dose between 1 mg and 10 mg.
Croatian: Ovo su upute za primjenu doze od 1 mg do 10 mg.
English: If you have any questions about Votubia or why it has been prescribed for you, ask your doctor.
Croatian: Imate li bilo kakvih pitanja o Votubii ili razlozima zbog kojih Vam je propisana, obratite se svome liječniku.
English: • 10 ml oral syringe with 1 ml increments (for single use): see figure below
Croatian: • Štrcaljka za usta od 10 ml s oznakama za doziranje u razmaku od 1 ml (za jednokratnu uporabu): vidjeti sliku ispod
English: The mTOR regulates protein synthesis and multiple downstream cellular functions that may influence neuronal excitability and epileptogenesis.
Croatian: mTOR regulira sintezu proteina i višestruke silazne stanične funkcije koje mogu utjecati na podražljivost neurona i epileptogenezu.
English: Use an oral syringe or a small glass for preparing and taking the Votubia suspension only - do not use it for anything else.
Croatian: Upotrijebite štrcaljku za usta ili malu čašu za pripremu i primjenu samo suspenzije Votubienemojte ih koristiti ni za što drugo.
English: Interaction - Change in Everolimus AUC/Cmax Geometric mean ratio (observed range)
Croatian: Interakcija - promjena u AUC/Cmax everolimusa Omjer geometrijskih sredina (zapaženi raspon)
English: The increase in the pre-dose concentrations of these antiepileptics may not be clinically significant but dose adjustments for antiepileptics with a narrow therapeutic index, e.g carbamazepine, may be considered.
Croatian: Povećanje koncentracija ovih antiepileptika prije doziranja možda nije klinički značajno, ali se može razmotriti prilagođavanje doze antiepileptika s uskim terapijskim indeksom, npr. karbamazepina.
English: PJP/PCP may be associated with concomitant use of corticosteroids or other immunosuppressive agents.
Croatian: PJP/PCP se može povezati s istodobnom primjenom kortikosteroida ili drugih imunosupresiva.
English: Population pharmacokinetic model simulations showed that a starting dose of 7 mg/m would be necessary to attain Cmin within the 5 to 15 ng/ml range in patients younger than 3 years of age.
Croatian: Simulacije modela populacijske farmakokinetike pokazale su da bi početna doza od 7 mg/m bila neophodna za postizanje Cmin unutar raspona od 5 do 15 ng/ml u bolesnika mlađih od 3 godine.
English: When possible, the same assay and laboratory for therapeutic drug monitoring should be used throughout the treatment.
Croatian: Kad je to moguće, tijekom liječenja potrebno je koristiti iste testove i laboratorij za praćenje terapijskih učinaka lijeka.
English: The tablets must be dispersed in water before administration.
Croatian: Tablete se moraju otopiti u vodi prije primjene.
English: Everolimus binds to the intracellular protein FKBP-12, forming a complex that inhibits mTOR complex-1 (mTORC1) activity.
Croatian: Everolimus se veže na unutarstanični protein FKBP-12, pri čemu stvara kompleks koji inhibira aktivnost mTOR kompleksa-1 (mTORC1).
English: Some infections may be severe and may have fatal consequences in adults and children.
Croatian: Neke infekcije mogu biti teške i imati smrtne posljedice u odraslih i djece. utjecati na funkciju bubrega.
English: In cases where the revised dose is not a multiple of 2.5 mg, it should be rounded to the next available tablet strength.
Croatian: U slučajevima gdje razmatrana doza nije višekratnik od 2,5 mg, potrebno ju je zaokružiti na sljedeću dostupnu jačinu tablete.
English: General supportive measures should be initiated in all cases of overdose.
Croatian: U svim slučajevima predoziranja mora se započeti s općim potpornim mjerama.
English: For adverse reactions of Grade 1, dose adjustment is usually not required.
Croatian: Za nuspojave stupnja 1, prilagođavanje doze obično nije potrebno.
English: Non-clinical studies in rats demonstrated distribution into the brain following administration by both the intravenous and oral routes.
Croatian: Neklinička ispitivanja na štakorima pokazala su distribuciju u mozgu nakon primjene i intravenskim i peroralnim putem.
English: Pour the water from the dose cup into the small glass.
Croatian: Nalijte vodu iz čašice za doziranje u malu čašu.
English: 95% CI p-value (versus placebo)
Croatian: 95% CI p-vrijednost (u odnosu na placebo)
English: Other symptoms may include altered kidney function test (increase in creatinine).
Croatian: Ostali simptomi mogu uključivati poremećene nalaze funkcije bubrega (porast kreatinina).
English: Median duration of treatment was 18 weeks for all three arms in the core phase and 90 weeks (21 months) when considering both the core and extension phases.
Croatian: Medijan trajanja liječenja bio je 18 tjedana za sve tri skupine u osnovnoj fazi i 90 tjedana (21 mjesec) kad se uzmu o obzir i osnovna faza i faza nastavka liječenja.
English: This may result in the need for insulin and/or oral antidiabetic agent therapy.
Croatian: To može dovesti do potrebe za inzulinom i/ili oralnim antidijabeticima.
English: In clinical studies, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome.
Croatian: U kliničkim ispitivanjima everolimus je bio povezan s ozbiljnim slučajevima reaktivacije hepatitisa B, uključujući smrtni ishod.
English: In the total population, 57.3% of patients were male and 93.2% were Caucasian.
Croatian: U ukupnoj populaciji, 57,3% bolesnika bilo je muškog spola, a 93,2% bijele rase.
English: In animal reproductive studies female fertility was not affected.
Croatian: U ispitivanjima reprodukcije provedenim na životinjama nije bilo utjecaja na plodnost ženki.
English: If symptoms are moderate, consideration should be given to interruption of therapy until symptoms improve.
Croatian: Ako su simptomi umjereni, mora se razmisliti o prekidu liječenja do poboljšanja simptoma.
English: The two pharmaceutical forms must not be combined to achieve the desired dose.
Croatian: Ova dva farmaceutska oblika ne smiju se kombinirati da bi se postigla željena doza.
English: Do not take a double dose to make up for the forgotten tablets.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljene tablete.
English: The effect of a ketogenic diet may be mediated through mTOR inhibition.
Croatian: Učinak ketogene dijete može biti posredovan mTOR inhibicijom.
English: Toxicity study with juvenile monkeys did not show any relevant toxicity.
Croatian: Ispitivanja toksičnosti na mladunčadi majmuna nisu otkrila nikakve značajne toksične učinke.
English: Oral clearance (CL/F) is similar in Japanese and Caucasian cancer patients with similar liver functions.
Croatian: Oralni klirens (CL/F) je sličan u Japanaca i bijelaca oboljelih od raka, uz sličnu funkciju jetre.
English: The study independently tested two different primary endpoints: 1) response rate defined as at least a 50% reduction from baseline in frequency of partial-onset seizures during the maintenance period of the core phase; and 2) percentage reduction from baseline in frequency of partial-onset seizures during the maintenance period of the core phase.
Croatian: U ispitivanju su se neovisno testirale dvije različite mjere primarnog ishoda: 1) stopa odgovora definirana kao smanjenje od najmanje 50% u odnosu na početnu vrijednost u učestalosti parcijalnih napadaja tijekom razdoblja održavanja u osnovnoj fazi; i 2) postotno smanjenje u odnosu na početnu vrijednost u učestalosti parcijalnih napadaja tijekom razdoblja održavanja u osnovnoj fazi.
English: Antifungal agents should not be used unless fungal infection has been diagnosed (see section 4.5).
Croatian: Antimikotici se ne smiju koristiti, osim ako nije dijagnosticirana gljivična infekcija (vidjeti dio 4.5).
English: These findings were generally observed at systemic exposure levels within the range of therapeutic exposure or above, with the exception of the findings in rats, which occurred below therapeutic exposure due to a high tissue distribution.
Croatian: Ovi nalazi su općenito zabilježeni pri razinama sistemske izloženosti unutar raspona terapijske izloženosti ili iznad nje, uz izuzetak nalaza u štakora koji se pojavio ispod razine terapijske izloženosti zbog visoke distribucije u tkivima.
English: Baseline seizure frequency and TN-Cmin were both significant factors (α=0.05) in predicting the absolute seizure frequency in the linear regression model.
Croatian: Početna učestalost napadaja i VN-Cmin bili su oboje značajni čimbenici (α=0,05) u predviđanju apsolutne učestalosti napadaja u linearnom regresijskom modelu.
English: How much Votubia to take
Croatian: Koliko Votubie uzeti
English: Ask your pharmacist how to throw away the oral syringe.
Croatian: Upitajte svog ljekarnika kako se bacaju štrcaljke za usta.
English: After the core treatment phase, patients could be enrolled into an extension phase where SEGA volume was assessed every 6 months.
Croatian: Nakon početne terapijske faze bolesnike se moglo uključiti u nastavak ispitivanja, tijekom kojega je volumen SEGA-e kontroliran svakih 6 mjeseci.
English: Votubia may elevate cholesterol and/or other blood fats.
Croatian: Votubia može povisiti razine kolesterola i/ili drugih masnoća u krvi.
English: If you forget to take Votubia
Croatian: Ako ste zaboravili uzeti Votubiu
English: Response rate (95% CI)
Croatian: Stopa odgovora (95% CI)
English: In this case, 25% of the dose calculated based on BSA (rounded to the nearest strength) must not be exceeded.
Croatian: U tom se slučaju ne smije premašiti 25% doze izračunate na temelju PT-a (zaokruženo na najbližu jačinu).
English: Votubia dispersible tablets are given together with other medicines for epilepsy.
Croatian: Votubia tablete za oralnu suspenziju daju se zajedno s drugim lijekovima za epilepsiju.
English: mTORC1 activation leads to a downstream kinase signalling cascade, including activation of the S6 kinases.
Croatian: Aktivacija mTORC1 dovodi do aktivacije kinaznog kaskadnog silaznog puta, uključujući i aktivaciju S6 kinaza.
English: Patients should be advised to be cautious when driving or using machines if they experience fatigue during treatment with Votubia.
Croatian: Bolesnicima je potrebno savjetovati da budu oprezni pri upravljanju vozilima ili radu sa strojevima ako tijekom liječenja Votubiom osjete umor.
English: For patients with TSC who have SEGA and are unable to swallow tablets, Votubia tablet(s) can be dispersed completely in a glass with approximately 30 ml of water by gently stirring until the tablet(s) is(are) fully disintegrated (approximately 7 minutes), immediately prior to drinking.
Croatian: Za bolesnike s KTS-om koji imaju SEGA-u i koji ne mogu gutati tablete, tableta(e) Votubie se može(gu) potpuno dispergirati u čaši s oko 30 ml vode laganim miješanjem sve dok se tableta(e) u potpunosti ne raspadne(u) (otprilike 7 minuta), neposredno prije nego će se popiti.
English: If you are taking any of them, your doctor may switch you to a different medicine, or may change your dose of Votubia.
Croatian: Uzimate li bilo koji od njih, Vaš liječnik može odlučiti propisati Vam neki drugi lijek ili izmijeniti Vašu dozu Votubie.
English: Management of stomatitis may therefore include prophylactic (in adults) 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 (u odraslih) i/ili terapijsku primjenu topikalnih pripravaka, kao što je uporaba bezalkoholne oralne otopine kortikosteroida kao otopine za ispiranje usta.
English: AUC ↓63% (range 0-80%) Cmax ↓58% (range 10-70%)
Croatian: AUC ↓63% (raspon 0-80%) Cmax ↓58% (raspon 10-70%)