FrancophonIA/ELRC3.0 huggingface dataset:
English: Interaction - Change in Everolimus AUC/Cmax Geometric mean ratio (observed range)
Slovenian: Interakcija - sprememba razmerja AUC/Cmax everolimusa razmerje geometričnih sredin (obseg dejanskih razmerij)
English: Phase III study in SEGA patients
Slovenian: Študija faze III pri bolnikih s SEGA
English: Progressions were observed in 3.8% of patients in the everolimus arm compared with 20.5% in the placebo arm.
Slovenian: Napredovanja so opažali pri 3,8 % bolnikov v skupini, ki je prejemala everolimus, v primerjavi z 20,5 % bolnikov v skupini, ki je prejemala placebo.
English: Inhibition of the mTORC1 signalling pathway interferes with the translation and synthesis of proteins by reducing the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic elongation factor 4E-binding protein (4EBP-1) that regulate proteins involved in the cell cycle, angiogenesis and glycolysis.
Slovenian: Zaviranje prenosa signala z mTORC1 ovira proces translacije in sintezo proteinov, tako da zmanjšuje delovanje S6 ribosomske protein-kinaze (S6K1) in vezavnega proteina za evkariontski dejavnik podaljševanja 4E (eukaryotic elongation factor 4E-binding protein - 4EBP-1), ki uravnavata proteine, vpletene v celični ciklus, angiogenezo in glikolizo.
English: What Votubia is and what it is used for What you need to know before you take Votubia How to take Votubia
Slovenian: Kaj je zdravilo Votubia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Votubia Kako jemati zdravilo Votubia Možni neželeni učinki
English: Do not use this medicine if the pack is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je pakiranje poškodovano ali da je bilo že odprto.
English: What you need to know before you take Votubia
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Votubia
English: Blood tests will also be carried out to check your kidney function (levels of creatinine, blood urea nitrogen or urinary protein), liver function (level of transaminases) and your blood sugar and lipid levels.
Slovenian: Krvne preiskave boste opravljali tudi za preverjanje delovanja ledvic (ravni kreatinina, sečninskega dušika v krvi ali beljakovin v urinu), delovanja jeter (ravni aminotransferaz) in ravni sladkorja ter maščob v krvi.
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.
Slovenian: Če pride do določenih neželenih učinkov (glejte poglavje 4) v času jemanja zdravila Votubia, vam bo zdravnik morda znižal odmerek ali prekinil zdravljenje z zdravilom Votubia, bodisi za krajši čas ali pa dokončno.
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.
Slovenian: Mediana trajanja zdravljenja je bila v osnovnem delu študije 18 tednov v vseh treh skupinah, oziroma skupaj 90 tednov (21 mesecev) v osnovnem delu študije in fazi podaljšanja.
English: The use of live vaccines should be avoided during treatment with Votubia (see section 4.5).
Slovenian: Med zdravljenjem z zdravilom Votubia se je treba izogibati uporabi živih cepiv (glejte poglavje 4.5).
English: Prepare the oral suspension by mixing the dispersible tablets with water either in an oral syringe or in a small glass.
Slovenian: Peroralno suspenzijo pripravite tako, da disperzibilne tablete zmešate z vodo bodisi v brizgi za peroralno dajanje ali v majhnem kozarcu.
English: In summary, everolimus is highly active in this neuronal model of TSC, with benefit apparently attributable to effects on mTORC1 inhibition.
Slovenian: Na kratko, everolimus je v nevronalnem modelu tuberozne skleroze zelo aktiven, pri čemer je njegove koristne učinke verjetno mogoče pripisati zaviralnemu delovanju na kompleks mTORC1.
English: How much Votubia to take
Slovenian: Koliko zdravila Votubia je treba jemati
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.
Slovenian: V študiji so neodvisno preverjali dva različna primarna cilja opazovanja: 1) delež bolnikov z odzivom, ki je bil opredeljen kot najmanj 50-odstotno zmanjšanje pogostnosti žariščnih epileptičnih napadov od izhodiščne vrednosti v obdobju vzdrževalnega zdravljenja v osnovnem delu študije in 2) odstotek zmanjšanja pogostnosti žariščnih epileptičnih napadov od izhodiščne vrednosti v obdobju vzdrževalnega zdravljenja v osnovnem delu študije.
English: Similarly, at the same timepoints, ≥50% reductions in volume were observed in 44.2%, 63.3%, and 68.9% of the treated patients, respectively.
Slovenian: Pri tem so ob istih terminih vrednotenja opažali ≥ 50-odstotno zmanjšanje volumna pri 44,2 %, 63,3 % oziroma 68,9 % zdravljenih bolnikov.
English: Table 3 Adverse reactions reported in TSC studies
Slovenian: Preglednica 3 Neželeni učinki, o katerih so poročali v TSC študijah
English: For cases where symptoms of non-infectious pneumonitis are severe, Votubia therapy should be discontinued and the use of corticosteroids may be indicated until clinical symptoms resolve.
Slovenian: V primerih močno izraženih simptomov neinfekcijske pljučnice je treba uporabo zdravila Votubia prekiniti, lahko je indicirana tudi uporaba kortikosteroidov, dokler klinični simptomi ne izzvenijo.
English: Six main metabolites of everolimus have been detected in human blood, including three monohydroxylated metabolites, two hydrolytic ring-opened products, and a phosphatidylcholine conjugate of everolimus.
Slovenian: Pri človeku so v krvi odkrili šest glavnih metabolitov everolimusa, med njimi tri monohidroksilirane metabolite, dva metabolita s hidrolitično odprtim obročem in en fosfatidil-holinski konjugat everolimusa.
English: Serious side effects of Votubia include:
Slovenian: Resni neželeni učinki zdravila Votubia vključujejo:
English: Votubia may increase blood sugar levels and worsen diabetes mellitus.
Slovenian: Zdravilo Votubia lahko zviša raven sladkorja v krvi in povzroči poslabšanje sladkorne bolezni.
English: If you are following a specific diet to reduce the frequency of your seizures, please inform your doctor before taking Votubia.
Slovenian: Če se držite posebne diete za zmanjšanje pogostnosti vaših epileptičnih napadov, o tem obvestite zdravnika preden začnete z jemanjem zdravila Votubia.
English: Everolimus has immunosuppressive properties and may predispose patients to bacterial, fungal, viral or protozoal infections, including infections with opportunistic pathogens (see section 4.8).
Slovenian: Everolimus ima imunosupresivne lastnosti in lahko pri bolnikih poveča nagnjenost k okužbam, ki jih povzročajo bakterije, glivice, virusi ali protozoji, vključno z okužbami z oportunističnimi patogeni (glejte poglavje 4.8).
English: After the dispersion has been swallowed, any residue must be re-dispersed in the same volume of water and swallowed (see section 5.2).
Slovenian: Po zaužitju mešanice je treba morebiten preostanek ponovno zmešati z enako količino vode in tudi to spiti (glejte poglavje 5.2).
English: Among patients treated with everolimus during the study, no cases of angiomyolipoma-related nephrectomy and only one case of renal embolisation were reported.
Slovenian: Med bolniki, ki so v času študije prejemali everolimus, ni bilo nobenega primera nefrektomije zaradi angiomiolipoma, in samo v enem primeru so poročali o opravljeni ledvični embolizaciji.
English: Other possible side effects of Votubia include:
Slovenian: Med drugimi možnimi neželenimi učinki zdravila Votubia so:
English: Preclinical studies in models of mTOR dysregulation in the brain demonstrated that treatment with an mTOR inhibitor such as everolimus could prolong survival, suppress seizures, prevent the development of new-onset seizures and prevent premature death.
Slovenian: V predkliničnih študijah modelov disregulacije, ki jo mTOR povzroča v možganih, se je pokazalo, da bi zdravljenje z zaviralci mTOR, kot je everolimus, lahko podaljšalo preživetje, zmanjšalo obseg epileptičnih napadov, preprečevalo razvoj epilepsije na novo in preprečilo prezgodnjo smrt.
English: In the everolimus treated population (N=111) of the study, including patients who crossed over from the placebo group, tumour response, starting as early as after 12 weeks on everolimus, was sustained at later time points.
Slovenian: V populaciji, ki je med študijo prejemala everolimus (N=111), vključno z bolniki, ki so prešli na everolimus iz skupine, ki je prejemala placebo, se je odziv tumorja, ki se je pričel že po 12 tednih zdravljenja, nadaljeval tudi ob kasnejših kontrolah.
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).
Slovenian: Glede na rezultate navedenih dveh študij je pri bolnikih z okvaro jeter priporočeno prilagajanje odmerjanja (glejte poglavji 4.2 in 4.4).
English: Healthcare professionals and patients should be vigilant for signs and symptoms of bleeding throughout the treatment period, especially if risk factors for haemorrhage are combined.
Slovenian: Zdravstveni delavci in bolniki morajo biti ves čas zdravljenja pozorni na znake ali simptome krvavitve, zlasti če gre pri bolniku za kombinacijo več dejavnikov tveganja za krvavitev.
English: The use of live vaccines should be avoided during treatment with Votubia.
Slovenian: Med zdravljenjem z zdravilom Votubia se je treba izogibati uporabi živih cepiv.
English: Table 4 Adverse reactions reported in TSC studies
Slovenian: Preglednica 4 Neželeni učinki, o katerih so poročali v TSC študijah
English: Non-infectious pneumonitis is a class effect of rapamycin derivatives, including everolimus.
Slovenian: Povzročanje neinfekcijske pljučnice je značilnost celotne skupine derivatov rapamicina, vključno z everolimusom.
English: If toxicity recurs at Grade 3, consider discontinuation.
Slovenian: Če se škodljivi učinki ponovijo na ravni stopnje 3, razmislite o prenehanju uporabe.
English: Take the carton and this leaflet, so that the doctor knows what has been taken.
Slovenian: S seboj vzemite škatlico vaših tablet in to navodilo za uporabo, da bo zdravnik vedel, kaj ste zaužili.
English: In this case, 25% of the dose calculated based on BSA (rounded to the nearest strength) must not be exceeded.
Slovenian: V takem primeru se ne sme prekoračiti 25 % odmerka po izračunu glede na telesno površino (zaokroženo na najbližjo jakost zdravila).
English: In the pivotal phase II study, 22 of the 28 SEGA patients studied were below the age of 18 years and in the pivotal phase III study, 101 of the 117 SEGA patients studied were below the age of 18 years.
Slovenian: V osrednji študiji faze II je bilo 22 izmed 28 bolnikov s SEGA mlajših od 18 let, v osrednji študiji faze III pa je bil izmed 117 bolnikov s SEGA 101 bolnik mlajši od 18 let.
English: Everolimus is not considered dialysable to any relevant degree (less than 10% was removed within 6 hours of haemodialysis).
Slovenian: Everolimus ne sodi med snovi, ki bi jih bilo mogoče v ustreznem obsegu odstranjevati z dializo (v 6 urah so ga z dializo odstranili manj kot 10 %).
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.
Slovenian: Stabilnost pripravljene suspenzije je dokazana za obdobje 30 minut, kadar se uporabi brizga za peroralno dajanje, oziroma za obdobje 60 minut, kadar se uporabi majhen kozarec.
English: There are no adequate data from the use of everolimus in pregnant women.
Slovenian: O uporabi everolimusa pri nosečnicah ni dovolj podatkov.
English: Light fat meals reduced AUC by 29.5% and Cmax by 50.2%.
Slovenian: Obroki z nizko vsebnostjo maščob so zmanjšali AUC za 29,5 %, Cmax pa za 50,2 %.
English: Light fat meals reduced AUC by 32% and Cmax by 42%.
Slovenian: Obroki z nizko vsebnostjo maščob so zmanjšali AUC za 32 %, Cmax pa za 42 %.
English: The tablets must be dispersed in water before administration.
Slovenian: Tablete je treba pred uporabo raztopiti v vodi.
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.
Slovenian: Med sekundarnimi cilji opazovanja so bili odsotnost epileptičnih napadov, delež bolnikov z več kot 25-odstotnim zmanjšanjem pogostnosti epileptičnih napadov od izhodiščne vrednosti, porazdelitev zmanjšanja pogostnosti epileptičnih napadov od izhodiščne vrednosti (≤-25 %; >-25 % do <25 %; ≥25 % do <50 %; ≥50 % do <75 %; ≥75 % do <100 %; 100 %), dolgoročna ocena pogostnosti epileptičnih napadov in skupna ocena kakovosti življenja.
English: Pull the plunger slowly down to draw in air until it is at the 9 ml mark on the syringe.
Slovenian: Bat počasi vlecite navzdol, tako da v brizgo potegnete zrak, dokler bat ne doseže oznake 9 ml na brizgi.
English: The analysis was stratified by use of enzyme-inducing antiepileptics at randomisation (yes/no).
Slovenian: Analiza je bila stratificirana glede na uporabo antiepileptikov, ki inducirajo encime, ob randomizaciji (da/ne).
English: In addition, all 8 patients on the Votubia arm who had radiographic evidence of hydrocephalus at baseline had a decrease in ventricular volume.
Slovenian: Poleg tega je pri vseh 8 bolnikih, ki so bili v skupini z zdravilom Votubia in so imeli ob izhodišču rentgensko dokazan hidrocefalus, prišlo do zmanjšanja volumna možganskih prekatov.
English: The number of oncology patients with an adverse reaction leading to discontinuation of everolimus was higher in patients ≥65 years of age (20% versus 13%).
Slovenian: Število onkoloških bolnikov z neželenimi učinki, zaradi katerih so prekinili zdravljenje z everolimusom, je bilo večje med bolniki v starosti ≥65 let (20 % v primerjavi s 13 %).
English: Everolimus crossed the placenta and was toxic to the foetus.
Slovenian: Everolimus je prehajal skozi posteljico in je bil toksičen za zarodek.
English: Gently stir the contents of the glass until the tablet(s) break apart (approximately 7 minutes) and then drink the contents immediately.
Slovenian: Vsebino kozarca rahlo mešajte, dokler tableta (ali več tablet) ne razpade (kar traja približno 7 minut), nato pa takoj spijte vsebino kozarca.
English: If you feel unusually tired (fatigue is a common side effect), take special care when driving or using machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če ste neobičajno utrujeni (utrujenost je pogost neželeni učinek), bodite pri vožnji in upravljanju s stroji posebno pozorni.
English: Further dose reduction may be required to manage adverse reactions (see sections 4.2 and 4.4).
Slovenian: Nadaljnje zniževanje odmerka je lahko potrebno v primeru neželenih učinkov (glejte poglavji 4.2 in 4.4).
English: Add the dispersible tablets into the water.
Slovenian: Disperzibilne tablete spustite v vodo.
English: Other symptoms may include fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), and pain in the upper right abdomen.
Slovenian: Drugi simptomi lahko vključujejo utrujenost, izgubo apetita, občutek slabosti, zlatenico (rumeno obarvanje kože) in bolečine v zgornjem delu trebuha.
English: • 30 ml dose cup for measuring water
Slovenian: • 30-mililitrsko odmerno skodelico za merjenje volumna vode
English: In clinical studies, everolimus has been associated with haemorrhage events.
Slovenian: V kliničnih študijah je bil everolimus povezan s krvavitvami.
English: if you need to receive a vaccine while taking Votubia as vaccination may be less effective.
Slovenian: če morate biti med zdravljenjem z zdravilom Votubia cepljeni, saj je cepivo lahko manj učinkovito.
English: It may reduce the size of brain tumours called subependymal giant cell astrocytomas (SEGA) which are also caused by TSC.
Slovenian: Lahko zmanjša obseg možganskih tumorjev z imenom subependimski gigantocelični astrocitomi (SEGA), ki jih prav tako povzroča tuberozna skleroza.
English: Use scissors to open the blister along the dotted line.
Slovenian: S škarjami odprite pretisni omot po perforirani črti.
English: Fertility Votubia may affect male and female fertility.
Slovenian: Zdravilo Votubia lahko vpliva na plodnost pri moških in ženskah.
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.
Slovenian: Možno je, da zvišanje koncentracije teh antiepileptikov pred naslednjim odmerjanjem ni klinično pomembno, je pa pri antiepileptikih z nizkim terapevtskim indeksom, kot je karbamazepin, morda smiselno razmisliti o prilagoditvi odmerkov.
English: Concomitant treatment of Votubia and potent inhibitors is not recommended.
Slovenian: Sočasna uporaba zdravila Votubia in močnih zaviralcev ni priporočena.
English: At the end of the core phase, overall quality of life in patients aged 2 to <11 years (as measured by the mean change from baseline in overall Quality Of Life score [total score] in the Childhood Epilepsy Questionnaire [QOLCE]) was maintained in each Votubia treatment arm as well as in the placebo arm.
Slovenian: Ob koncu osnovnega dela študije se je celokupna kakovost življenja bolnikov, starih od 2 leti do manj kot 11 let (glede na povprečne spremembe od izhodiščne vrednosti po rezultatih vprašalnika za oceno kakovosti življenja z epilepsijo v otroštvu [Quality Of Life in Childhood Epilepsy QuestionnaireQOLCE]), ohranila v obeh skupinah z zdravilom Votubia in tudi v skupini s placebom.
English: The incidence of Grade ≥2 stomatitis at 8 weeks was 2.4% (n=2/85 evaluable patients) which was lower than historically reported.
Slovenian: Po 8 tednih je bila pogostnost stomatitisa stopnje ≥2 2,4 % (n=2/85 bolnic, ki so bile primerne za ocenjevanje), kar je manj kot po historičnih podatkih.
English: Grade 2 (≥1x10
Slovenian: Stopnja 2 (≥1x10
English: The patient must immediately drink all of the oral suspension from the glass.
Slovenian: Bolnik mora takoj spiti vso peroralno suspenzijo iz kozarca.
English: Key secondary endpoints included time to angiomyolipoma progression and skin lesion response rate.
Slovenian: Ključna sekundarna cilja opazovanja sta vključevala čas do napredovanja angiomiolipoma in delež odziva patoloških sprememb kože.
English: Special information for caregivers
Slovenian: Posebne informacije za negovalce
English: These tumours are caused by a genetic disorder called tuberous sclerosis complex (TSC).
Slovenian: Vzrok teh tumorjev je genetska motnja, ki se imenuje tuberozna skleroza.
English: Patients <18 years of age:
Slovenian: Bolniki, stari 18 let ali več:
English: Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.
Slovenian: Zdravilo Votubia je indicirano za zdravljenje odraslih bolnikov z ledvičnim angiomiolipomom v povezavi s tuberozno sklerozo (TSC), pri katerih obstaja nevarnost zapletov (na podlagi dejavnikov kot so velikost tumorja ali prisotnost anevrizme ali prisotnost multiplih ali obojestranskih tumorjev), vendar pri njih takojšen kirurški poseg ni potreben.
English: Push the plunger up slowly to remove most of the air.
Slovenian: Počasi pritiskajte bat, s čimer boste odstranili večino zraka.
English: The evidence is based on analysis of change in sum of angiomyolipoma volume.
Slovenian: Dokazi temeljijo na analizi spremembe skupnega volumna angiomiolipoma.
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.
Slovenian: Varnost, prenosljivost in farmakokinetične lastnosti zdravila Votubia so ocenjevali v dveh študijah tablet Votubia z enkratnim peroralnim odmerkom pri 8 oziroma 34 odraslih osebah z okvaro jeter v primerjavi z osebami z normalnim delovanjem jeter.
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.
Slovenian: Analiza prvega ključnega sekundarnega cilja opazovanja (spremembe pogostnosti epileptičnih dogodkov) ni dala prepričljivih rezultatov, pa tudi sicer pozitivnih rezultatov za oba druga sekundarna cilja opazovanja (za čas do napredovanja SEGA in za delež bolnikov z odzivom kožnih sprememb) ni bilo mogoče uvrstiti med formalno statistično značilne.
English: If a higher dose or number of tablets is required, an additional syringe must be prepared.
Slovenian: Če je potreben višji odmerek ali večje število tablet, je treba pripraviti še eno brizgo.
English: Other non-haematological toxicities (excluding metabolic events)
Slovenian: Drugi nehematološki škodljivi učinki (z izjemo učinkov na presnovo)
English: If dose reduction is required, the recommended dose is approximately 50% lower than the daily dose previously administered.
Slovenian: Če je potrebno znižanje odmerka, je priporočeni odmerek za približno 50 % nižji od predhodno uporabljanega dnevnega odmerka.
English: In a population pharmacokinetic analysis of 170 patients with advanced solid tumours, no significant influence of creatinine clearance (25-178 ml/min) was detected on CL/F of everolimus.
Slovenian: V analizi populacijske farmakokinetike 170 bolnikov z napredovalim trdim tumorjem niso ugotovili pomembnega vpliva očistka kreatinina (25-178 ml/min) na CL/F everolimusa.
English: Treatment with Votubia should be initiated by a physician experienced in the treatment of patients with TSC and therapeutic drug monitoring.
Slovenian: Zdravljenje z zdravilom Votubia sme uvesti zdravnik, ki ima izkušnje z zdravljenjem bolnikov s tuberozno sklerozo in s terapevtskim spremljanjem uporabe zdravila.
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.
Slovenian: • Največja količina zdravila, ki jo lahko vzamete naenkrat z eno brizgo za peroralno dajanje ali z enim majhnim kozarcem, je skupen odmerek 10 mg in v skupni količini največ 5 disperzibilnih tablet.
English: The prescribed dose of Votubia dispersible tablets should be placed in a small glass (maximum size 100 ml) containing approximately 25 ml of water.
Slovenian: Disperzibilne tablete zdravila Votubia v predpisanem odmerku je treba položiti v majhen kozarec (največ 100-mililitrski), v katerem je že približno 25 ml vode.
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.
Slovenian: Redne preiskave krvi so potrebne tudi za določanje količine zdravila Votubia v vaši krvi, saj bo na podlagi tega zdravnik lažje določil, koliko zdravila Votubia morate jemati.
English: Table 7 EXIST-1 - SEGA response
Slovenian: Preglednica 7 EXIST-1 - Odziv SEGA
English: Oral clearance (CL/F) is similar in Japanese and Caucasian cancer patients with similar liver functions.
Slovenian: Peroralni očistek (CL/F) je podoben pri japonskih bolnikih z rakom in pri bolnikih bele rase z rakom, ki imajo podobno stopnjo delovanja jeter.