FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4 shows the incidence of adverse reactions based on pooled data of patients receiving everolimus in the three TSC studies (including both the double-blind and open-label extension phase, where applicable).
Estonian: Tabelis 4 on esitatud everoliimust saanud patsientide kõrvaltoimete esinemissagedused vastavalt kolme tuberoosse skleroosi kompleksi uuringu ühendatud andmetele (sealhulgas topeltpime ja avatud sildiga jätku-uuringu faas, kui see on asjakohane).
English: High level of lipids (fats) in the blood (hypercholesterolaemia) Decreased appetite
Estonian: Kõrge lipiidide (rasvade) sisaldus veres (hüperkolesteroleemia) Söögiisu vähenemine
English: Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with Votubia (see section 4.8).
Estonian: Votubia-ravi saanud patsientidel on täheldatud neerupuudulikkuse (sealhulgas ägeda neerupuudulikkuse) juhtusid, kusjuures osa neist surmlõppega (vt lõik 4.8).
English: Pull the plunger slowly down to draw in air until it is at the 9 ml mark on the syringe.
Estonian: Tõmmake kolbi õhku kuni 9 ml märgini süstlal.
English: Do not take a double dose to make up for the forgotten tablets.
Estonian: Ärge võtke kahekordset annust, kui tablett jäi eelmisel korral võtmata.
English: For children with SEGA or seizures, it is important to have a discussion with the doctor about the childhood vaccination program before treatment with Votubia.
Estonian: Subependümaalse hiidrakulise astrotsütoomiga või hoogudega laste ravimisel Votubiaga on tähtis eelnevalt arstiga nõu pidada lapseea vaktsineerimiskava osas.
English: Results showed that the primary objective related to best overall angiomyolipoma response was met with best overall response rates of 41.8% (95% CI: 30.8, 53.4) for the Votubia arm compared with 0% (95% CI: 0.0, 9.0) for the placebo arm (p<0.0001) (Table 4).
Estonian: Tulemused näitasid, et üldise angiomüolipoomi ravivastus (esmane tulemusnäitaja) saavutati ning üldise ravivastuse määrad olid 41,8% (95% CI: 30,8, 53,4) Votubia rühmas ja 0% (95% CI: 0,0, 9,0) platseeborühmas (p<0,0001) (tabel 4).
English: The long-term follow-up of patients randomised to everolimus and patients randomised to placebo who thereafter crossed over to everolimus demonstrated durable responses.
Estonian: Nii everoliimuse rühma randomiseeritud kui platseeborühmast üle tulnud patsientidel säilis ka pikaajalisel jälgmisel kestev ravivastus.
English: Take Votubia dispersible tablets as an oral suspension only Do not chew or crush the dispersible tablets.
Estonian: Votubia dispergeeruvaid tablette võtke ainult suukaudse suspensioonina Dispergeeruvaid tablette ei tohi närida ega purustada.
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,
Estonian: Homogeenset ja järjepidevat everoliimuse toimet täheldati kõigis alarühmades, milles hinnati esmast efektiivsuse tulemusnäitajat: vanuse kategooriad (tabel 6), sugu, rass ja etnilisus, hoogude tüübid, hoogude sagedus uuringu alguses, kaasuvate epilepsiavastaste ravimite arv ja nimi ning tuberoosse skleroosi kompleksi tunnused (angiomüolipoom, subependümaalne hiidrakuline astrotsütoom, kortikaalsete köbrukeste staatus).
English: Each Votubia 2.5 mg tablet contains 2.5 mg of everolimus.
Estonian: Iga Votubia 2,5 mg tablett sisaldab 2,5 mg everoliimust.
English: Dose adjustments due to adverse reactions
Estonian: Annuse kohandamine kõrvaltoimete korral
English: Votubia 2.5 mg tablets
Estonian: Votubia 2,5 mg tabletid
English: Grade 3
Estonian: 3. aste
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.
Estonian: Tuberoosse skleroosi kompleksiga kaasnev neeru angiomüolipoom EXIST-2 (uuring CRAD001M2302), randomiseeritud, kontrollitud, III faasi uuring viidi läbi hindamaks Votubia efektiivsust ja ohutust patsientidel, kellel oli tuberoosse skleroosi kompleks koos neeru angiomüolipoomiga.
English: Follow all the doctor's instructions carefully.
Estonian: Järgige hoolikalt kõiki arsti juhiseid, isegi kui need erinevad infolehes sisalduvast üldisest teabest.
English: If the suspension is not used within 60 minutes, throw it away and prepare a new suspension.
Estonian: Kui suspensiooni ei kasutata 60 minuti jooksul, tuleb see ära visata ja valmistada uus.
English: Efficacy, safety, concomitant therapy, and the current trough concentration should be considered when planning for dose titration.
Estonian: Annuse tiitrimist plaanides tuleb arvestada efektiivsust, ohutust, kaasuvat ravi ja olemasolevat minimaalset kontsentratsiooni.
English: Starting dose without co-administration of CYP3A4/PgP inducer
Estonian: Algannus manustamisel ilma CYP3A4/PgP indutseerijata
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.
Estonian: Vereproove võetakse ka neerutalitluse (kreatiniini taseme, vere kusihappe sisalduse, uurea lämmastiku taseme veres või valgutaseme uriinis), maksatalitluse (transaminaaside taseme) ja veresuhkru taseme ning vere lipiidide taseme kontrollimiseks, kuna Votubia võib mõjutada ka neid näitajaid.
English: It is used to treat children aged 2 years and above and adults with partial seizures with or without secondary generalisation (epilepsy) associated with a genetic disorder called tuberous sclerosis complex (TSC) and which are not controlled by other antiepileptic medicines.
Estonian: Seda kasutatakse tuberoosse skleroosi kompleksi nimelisest geneetilisest häirest tingitud partsiaalsete hoogude (epilepsia), koos sekundaarse generaliseerumisega või ilma, raviks täiskasvanutel ja 2-aastastel või vanematel lastel, kui need hood ei allu teistele epilepsiavastastele ravimitele.
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.
Estonian: Kui kontsentratsioon on alla 5 ng/ml, võib ööpäevast annust suurendada 1…4 mg võrra, kuid kontrollida tuleb minimaalset
English: higher starting dose of 7 mg/m is recommended for patients 1 to less than 3 years of age based on pharmacokinetic simulations (see section 5.2).
Estonian: Farmakokineetilise simulatsiooni põhjal on suurem algannus, 7 mg/m2, soovitatav patsientidele vanuses alates 1 aasta kuni vähem kui 3 aastat (vt lõik 5.2).
English: 30 x 1 tablets 100 x 1 tablets
Estonian: 30 x 1 tabletti 100 x 1 tabletti
English: Large decrease in exposure expected.
Estonian: Oodata on ekspositsiooni olulist suurenemist.
English: Wound healing complications
Estonian: Haavaparanemise komplikatsioonid
English: 10 x 1 dispersible tablets 30 x 1 dispersible tablets 100 x 1 dispersible tablets
Estonian: 10 x 1 dispergeeruvat tabletti 30 x 1 dispergeeruvat tabletti 100 x 1 dispergeeruvat tabletti
English: Starting dose with co-administration of CYP3A4/PgP inducer
Estonian: Algannus manustamisel koos CYP3A4/PgP indutseerijaga
English: • ≥18 years of age with SEGA or refractory seizures and concomitant severe hepatic impairment (Child-Pugh C) unless the potential benefit outweighs the risk (see sections 4.2 and
Estonian: • ≥18 aastased patsiendid, kellel on subependümaalne hiidrakuline astrotsütoom või refraktaarsed hood ja kaasuv raske maksakahjustus (Child-Pugh klass C), v.a kui oodatav kasu ületab kaasnevad riskid (vt lõigud 4.2 ja 5.2).
English: If you do not drink it within 30 minutes when using an oral syringe or within 60 minutes when using a small glass, throw it away and prepare a new suspension.
Estonian: Kui te ei joo seda 30 minuti jooksul pärast suusüstla kasutamist või 60 minuti jooksul pärast väikese klaasi kasutamist, visake see ära visata ja valmistage uus suspensioon.
English: Consistently take only the tablets or only the dispersible tablets, and never a combination of both.
Estonian: Kasutage järjest ainult tablette või dispergeeruvaid tablette, ärge kasutage neid vaheldumisi.
English: At the time of the primary analysis, Votubia demonstrated clinically meaningful improvements in skin lesion response (p=0.0004), with response rates of 41.7% (95% CI: 30.2, 53.9) for the Votubia arm and 10.5% (95% CI: 2.9, 24.8) for the placebo arm. At the final analysis, the skin lesion response rate increased to 58.1% (95% CI: 48.1, 67.7).
Estonian: Esmase analüüsi mistahes ajahetkel ilmnes Votubiat saanutel nahakollete ravivastuses kliiniliselt oluline paranemine (p=0,0004), ravivastuse määrad oli Votubiarühmas 41,7% (95% CI: 30,2; 53,9) ja platseeborühmas 10,5% (95% CI: 2,9; 24,8).
English: Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets everolimus
Estonian: Votubia 2,5 mg tabletid Votubia 5 mg tabletid Votubia 10 mg tabletid everoliimus (everolimusum)
English: Do not take a double dose to make up for the forgotten dispersible tablets.
Estonian: Ärge võtke kahekordset annust, kui dispergeeruv tablett jäi eelmisel korral võtmata.
English: Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets everolimus
Estonian: Votubia 1 mg dispergeeruvad tabletid Votubia 2 mg dispergeeruvad tabletid Votubia 3 mg dispergeeruvad tabletid Votubia 5 mg dispergeeruvad tabletid everoliimus (everolimusum)
English: Table 7 Change in primary SEGA volume over time
Estonian: Tabel 7 Primaarse subependümaalse hiidrakulise astrotsütoomi mahu muutus ajas
English: Excipient with known effect Each tablet contains 149 mg lactose.
Estonian: Teadaolevat toimet omav abiaine Iga tablett sisaldab 149 mg laktoosi.
English: Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported in patients treated with Votubia (see section 4.8).
Estonian: Votubia-ravi saavatel patsientidel on registreeritud hemoglobiini, lümfotsüütide, neutrofiilide ja trombotsüütide taseme vähenemist (vt lõik 4.8).
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 tablets.
Estonian: Pakendid sisaldavad 10 x 1, 30 x 1 või 100 x 1 tabletti.
English: 30 x 1 dispersible tablets 100 x 1 dispersible tablets
Estonian: 30 x 1 dispergeeruvat tabletti 100 x 1 dispergeeruvat tabletti
English: Each Votubia 10 mg tablet contains 10 mg of everolimus.
Estonian: Iga Votubia 10 mg tablett sisaldab 10 mg everoliimust.
English: For children with SEGA, it is important to have a discussion with the doctor about the childhood vaccination program before treatment with Votubia.
Estonian: Subependümaalse hiidrakulise astrotsütoomiga laste ravimisel Votubiaga on tähtis eelnevalt arstiga nõu pidada lapseea vaktsineerimiskava osas.
English: Dosing should be titrated to attain trough concentrations of 5 to 15 ng/ml.
Estonian: Annust tuleb tiitrida nii, et minimaalne kontsentratsioon oleks 5…15 ng/ml.
English: Votubia 10 mg tablets are white to slightly yellowish, elongated tablets.
Estonian: Votubia 10 mg on valged kuni kergelt kollakad, piklikud tabletid.
English: Insomnia, aggression, irritability Nervous system disorders Very common Headache Uncommon Dysgeusia Vascular disorders Very common Hypertension Common
Estonian: Unetus, agressioon, ärrituvus Närvisüsteemi häired Väga sage
English: No serious cases of renal haemorrhage were reported in the TSC setting.
Estonian: Tuberoosse skleroosi kompleksi näidustuse puhul tõsistest neeru hemorraagia juhtumitest ei teatatud.
English: Lymphoedema
Estonian: Lümfödeem
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).
Estonian: Ravimi minimaalset kontsentratsiooni tuleb määrata vähemalt 1 nädala möödumisel esimese annuse manustamisest, pärast igat annuse või ravimvormi muutust, pärast CYP3A4 inhibiitorite samaaegse manustamise alustamist või muutust nende manustamises (vt lõigud 4.4 ja 4.5) või pärast igat muutust maksa seisundis (Child-Pugh järgi) (vt allpool lõik „Maksakahjustus“ ja lõik 5.2).
English: Excipient with known effect Each dispersible tablet contains 0.98 mg lactose.
Estonian: Teadaolevat toimet omav abiaine Iga dispergeeruv tablett sisaldab 0,98 mg laktoosi.
English: • <18 years of age with SEGA and concomitant hepatic impairment (Child-Pugh A, B and C)
Estonian: • <18 aastased patsiendid, kellel on subependümaalne hiidrakuline astrotsütoom või refraktaarsed hood ja kaasuv maksakahjustus (Child-Pugh klass A, B ja C) (vt lõigud 4.2 ja
English: 10 x 1 tablets
Estonian: 10 x 1 tabletti
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 “Hepatic impairment” below and section 5.2).
Estonian: Ravimi minimaalset kontsentratsiooni tuleb määrata vähemalt 1 nädala möödumisel esimese annuse manustamisest, pärast igat annuse või ravimvormi muutust, pärast CYP3A4 inhibiitorite samaaegse manustamise alustamist või muutust nende manustamises (vt lõigud 4.4 ja 4.5) või pärast igat muutust maksa seisundis (Child-Pugh järgi) (vt allpool „Maksakahjustus“ ja lõik 5.2).
English: Headache, pressure in the eyes, nose or cheek area (signs of inflammation of the sinuses and nasal passages, also known as sinusitis)
Estonian: Peavalu, survetunne silmades, ninas ja põskedes (ninaurgete ja -käikude põletiku nähud, kutsutakse ka sinusiidiks)
English: Wash the glass and the spoon thoroughly with clean water.
Estonian: Peske puhta veega hoolikalt klaas ja lusikas.
English: Getting ready
Estonian: Ettevalmistus
English: Odds ratio (versus placebo)
Estonian: Šansside suhe (võrreldes platseeboga)
English: Insert the tip of the oral syringe into the glass filled with water.
Estonian: Asetage suusüstla ots veega täidetud klaasi.
English: They are engraved with “LCL” on one side and “NVR” on the other.
Estonian: Tableti ühel küljel on graveering „LCL“ ja teisel küljel „NVR“.
English: Ciclosporin oral
Estonian: Infolehes sisukord
English: 30 x 1 tablets
Estonian: 30 x 1 tabletti
English: Votubia is indicated for the treatment of adult and paediatric patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.
Estonian: Votubia on näidustatud tuberoosse skleroosi kompleksiga kaasneva subependümaalse hiidrakulise astrotsütoomi raviks täiskasvanutel ja lastel, kes vajavad ravi, kuid kellel kirurgiline ravi ei ole näidustatud.
English: The safety, efficacy and pharmacokinetic profile of Votubia in children below the age of 2 years with TSC and refractory seizures have not been established.
Estonian: Tuberoosse skleroosi kompleksiga kaasnevate refraktaarsete hoogudega lastel vanuses alla 2 aasta ei ole Votubia ohutus, efektiivsus ja farmakokineetiline profiil tõestatud.
English: Stomach upset like feeling sick (nausea)
Estonian: Seedehäired, nagu halb enesetunne (iiveldus)
English: Votubia 5 mg tablets
Estonian: Votubia 5 mg tabletid
English: While taking Votubia, be vigilant for symptoms and signs of infection; if a diagnosis of infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of Votubia.
Estonian: Kui infektsioon diagnoositakse, tuleb viivitamatult määrata asjakohane ravi ning kaaluda ravi katkestamist või lõpetamist Votubiaga.
English: The entire contents of the syringe should be administered.
Estonian: Manustada kogu süstla sisu.
English: Adjust the dose by increments of 1 to 4 mg as necessary to maintain the target trough concentration.
Estonian: Kohandage annust minimaalse sihtkontsentratsiooni säilitamiseks vajaduse korral 1…4 mg võrra.
English: A prospective, open-label, single-arm phase II study (Study CRAD001C2485) was conducted to evaluate the safety and efficacy of Votubia in patients with SEGA.
Estonian: Votubia ohutuse ja efektiivsuse hindamiseks subependümaalse hiidrakulise astrotsütoomiga patsientidel teostati prospektiivne avatud ühe rühmaga II faasi uuring (CRAD001C2485).
English: Epistaxis, pneumonitis Gastrointestinal disorders Very common Stomatitis b, diarrhoea, vomiting
Estonian: Stomatiit b, kõhulahtisus, oksendamine
English: Re-initiate Votubia at approximately 50% lower than the daily dose previously administered.
Estonian: Taasalustada Votubia-ravi ligikaudu 50% väiksema ööpäevase annusega kui eelnevalt manustatud.
English: High levels of sugar in the blood (hyperglycaemia)
Estonian: Kõrge veresuhkru tase (hüperglükeemia)
English: Refractory seizures associated with tuberous sclerosis complex (TSC)
Estonian: Tuberoosse skleroosi kompleksiga kaasnevad refraktaarsed hood
English: You should not breast-feed during treatment and for 2 weeks after the last dose of Votubia.
Estonian: Ravi ajal ning 2 nädala jooksul pärast ravimi viimast annust ei tohi te last rinnaga toita.
English: Votubia 5 mg tablets are white to slightly yellowish, elongated tablets.
Estonian: Votubia 5 mg on valged kuni kergelt kollakad, piklikud tabletid.
English: Grade 4
Estonian: 4. aste
English: Response rates were 34.6% (95% CI: 24.2, 46.2) for the Votubia arm compared with 0% (95% CI: 0.0, 9.0) for the placebo arm (Table 6).
Estonian: Ravivastuste määrad olid Votubia rühmas 34,6% (95% CI: 24,2; 46,2) ja platseeborühmas 0% (95% CI: 0,0; 9,0) (tabel 6).
English: 100 x 1 tablets
Estonian: 100 x 1 tabletti
English: If you receive Votubia for the treatment of SEGA associated with TSC, 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.
Estonian: Kui te saate Votubiat tuberoosse skleroosi kompleksiga kaasneva subependümaalse hiidrakulise astrotsütoomi raviks, tuleb korrapäraseid vereanalüüse teha selleks, et mõõta, kui palju Votubiat on teie veres.
English: Each tablet contains 2.5 mg everolimus.
Estonian: Iga tablett sisaldab 2,5 mg everoliimust.
English: Excipient with known effect Each dispersible tablet contains 4.90 mg lactose.
Estonian: Teadaolevat toimet omav abiaine Iga dispergeeruv tablett sisaldab 4,90 mg laktoosi.
English: Consistent treatment effects were observed across all subgroups evaluated (i.e. enzyme-inducing antiepileptic use versus enzyme-inducing antiepileptic non-use, sex and age) at the primary analysis.
Estonian: Esmases analüüsis täheldati kõigis hinnatud alarühmades (st ensüümi indutseerivate epilepsiavastaste ravimite kasutajad või mittekasutajad, sugu ja vanus) sarnaseid ravitoimeid.
English: Votubia 2.5 mg tablets everolimus
Estonian: Votubia 2,5 mg tabletid everolimusum
English: Metabolic events (e.g. hyperglycaemia, dyslipidaemia)
Estonian: Metaboolsed sündmused (nt hüperglükeemia, düslipideemia)
English: If the patient does not drink it within 30 minutes if an oral syringe has been used or within 60 minutes if a small glass has been used, throw it away and prepare a new suspension.
Estonian: Kui patsient ei joo seda 30 minuti jooksul pärast suusüstla kasutamist või 60 minuti jooksul pärast väikese klaasi kasutamist, tuleb see ära visata ja uus suspensioon valmistada.
English: Otitis media, cellulitis, pharyngitis streptococcal, gastroenteritis viral, gingivitis Uncommon Herpes zoster, sepsis, bronchitis viral Blood and lymphatic system disorders Common
Estonian: Vöötohatis, sepsis, viiruslik bronhiit Vere ja lümfisüsteemi häired Sage
English: Response rates were 34.6% (95% CI: 24.2, 46.2) for the Votubia arm compared with 0% (95% CI: 0.0, 9.0) for the placebo arm (Table 7).
Estonian: Ravivastuste määrad olid Votubia rühmas 34,6% (95% CI: 24,2; 46,2) ja platseeborühmas 0% (95% CI: 0,0; 9,0) (tabel 7).
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 dispersible tablets.
Estonian: Pakendid sisaldavad 10 x 1, 30 x 1 või 100 x 1 dispergeeruvat tabletti.
English: 10 The patient must drink all of the oral suspension from the glass.
Estonian: Patsient peab jooma klaasist kogu suukaudse lahuse.
English: Excipient with known effect Each dispersible tablet contains 2.94 mg lactose.
Estonian: Teadaolevat toimet omav abiaine Iga dispergeeruv tablett sisaldab 2,94 mg laktoosi.
English: Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein or serum creatinine, is recommended prior to the start of Votubia therapy and periodically thereafter.
Estonian: Enne ravi alustamist Votubiaga ja korrapäraselt ravi ajal on soovitatav jälgida neerutalitlust, sealhulgas mõõta vere jääklämmastikku, proteiinide sisaldust uriinis või seerumi kreatiniinitaset.
English: Votubia dispersible tablets contain an active substance called everolimus.
Estonian: Mida Votubia dispergeeruvad tabletid sisaldavad Toimeaine on everoliimus.
English: Votubia dispersible tablets are used to treat SEGA associated with TSC in adults and children for whom surgery is not appropriate.
Estonian: Votubia dispergeeruvaid tablette kasutatakse tuberoosse skleroosi kompleksist tingitud subependümaalse hiidrakulise astrotsütoomi raviks täiskasvanutel ja lastel, keda ei saa opereerida.
English: High level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides) Low level of phosphate in the blood (hypophosphataemia) High level of sugar in the blood (hyperglycaemia) Tiredness, breathlessness, dizziness, pale skin (signs of low level of red blood cells, also known as anaemia)
Estonian: Lipiidide (rasvade) suur hulk veres (hüperlipideemia, kõrge triglütseriidide tase) Madal fosfaadi tase veres (hüpofosfateemia)
English: Table 4 Adverse reactions reported in TSC studies
Estonian: Tabel 4 Tuberoosse skleroosi kompleksi uuringutes registreeritud kõrvaltoimed
English: Wort should not be used during treatment with everolimus
Estonian: Everoliimuse ravi ajal ei tohi kasutada naistepuna sisaldavaid preparaate.
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.
Estonian: See oli randomiseeritud, topeltpime, kontrolliga, III faasi uuring, mis võrdles everoliimuse väikese ja suure ekspositsiooniga (väikese minimaalse kontsentratsiooni [LT] vahemik 3…7 ng/ml [n=117] ja suure minimaalse kontsentratsiooni [HT] vahemik 9…15 ng/ml [n=130]) täiendavat ravi platseeboga (n=119) tuberoosse skleroosi kompleksi ja refraktaarsete partsiaalsete hoogudega patsientidel, kes said 1…3 epilepsiavastast ravimit.
English: Children and adolescents Votubia can be used in children and adolescents with SEGA associated with TSC.
Estonian: Votubiat võib kasutada lastel ja noorukitel, kellel on tuberoossest skleroosi komplekist tingitud subependümaalne hiidrakuline astrotsütoom.
English: Remove the dispersible tablets from the blister.
Estonian: Eemaldage dispergeeruvad tabletid blistrist.
English: Elevations of serum creatinine, usually mild, and proteinuria have been reported in patients treated with Votubia (see section 4.8).
Estonian: Votubia-ravi saavatel patsientidel on registreeritud seerumi kreatiniinitaseme tõusu, mis on tavaliselt kergekujuline ja proteinuuriat (vt lõik 4.8).
English: • ≥18 years of age and concomitant severe hepatic impairment (Child-Pugh C) unless the potential benefit outweighs the risk (see sections 4.2 and 5.2).
Estonian: • kellel on tuberoosse skleroosi kompleksiga kaasnev neeru angiomüolipoom ja kaasuv raske maksakahjustus (Child-Pugh klass C) välja arvatud juhul kui potentsiaalne kasu on suurem kui risk (vt lõigud 4.2 ja 5.2).