FrancophonIA/ELRC3.0 huggingface dataset:
English: At baseline, 19.4% of patients had focal seizures with retained awareness (sensory previously confirmed on EEG or motor), 45.1% had focal seizures with impaired awareness (predominantly nonmotor), 69.1% had focal motor seizures (i.e. focal motor seizures with impaired awareness and/or secondary generalised seizures), and 1.6% had generalised onset seizures (previously confirmed by EEG).
Estonian: Uuringu alguses oli 19,4%-l patsientidest fokaalsed hood ilma teadvuse häireta (sensoorsed ilmingud eelnevalt kinnitatud EEGga või motoorsed ilmingud), 45,1%-l olid fokaalsed motoorsed hood (nt fokaalsed motoorsed hood, millega kaasnesid teadvusehäire ja/või sekundaarselt generaliseerunud hood) teadvuse häirega (peamiselt mittemotoorsed), 69,1%-l olid fokaalsed motoorsed hood ja 1,6%-l generaliseerunud algusega hood (eelnevalt kinnitatud EEG-ga).
English: Votubia with food and drink Avoid grapefruit and grapefruit juice while you are on Votubia.
Estonian: Votubia koos toidu ja joogiga Votubia võtmise ajal tuleb hoiduda greibi ja greibimahla tarvitamisest.
English: The effect of everolimus on infantile/epileptic spasms or on seizures associated with Lennox-Gastaut syndrome has not been studied and is not established for generalised-onset seizures and subjects without cortical tubers.
Estonian: Uuritud ei ole everoliimuse toimet imikute/epileptilistele spasmidele või Lennox-Gastaut sündroomiga seotud hoogudele ning kindlaks ei ole tehtud toimet generaliseerunud algusega hoogudele ega patsientidele, kellel ei esine kortikaalseid köbrukesi.
English: You will have blood tests during treatment with Votubia.
Estonian: Votubia võtmise ajal võetakse teilt vereanalüüse.
English: One patient met the pre-specified criteria for treatment success (>75% reduction in SEGA volume) and was temporarily taken off trial therapy; however, SEGA re-growth was evident at the next assessment at 4.5 months and treatment was restarted.
Estonian: Üks patsient vastas uuringuplaanis kirjeldatud raviedukuse kriteeriumitele (subependümaalse hiidrakulise astrotsütoomi mahu >75% vähenemine) ja uuringuravimi manustamine talle lõpetati ajutiselt; siiski ilmnes 4,5 kuu hindamisel subependümaalse hiidrakulise astrotsütoomi tagasikasvamine, mistõttu alustati uuesti raviga.
English: Three randomised, double-blind, placebo-controlled pivotal phase III studies, including double-blind and open label treatment periods, and a non-randomised, open-label, single-arm phase II study contribute to the safety profile of Votubia (n=612, including 409 patients <18 years of age; median duration of exposure 36.8 months [range 0.5 to 83.2]).
Estonian: Votubia ohutusalased andmed pärinevad kolmest kesksest randomiseeritud, topeltpimedast, platseebokontrolliga III faasi uuringutest, kus olid nii topeltpimedad kui avatud uuringu faasid, ja randomiseerimata, avatud, ühe rühmaga II faasi uuringust (n=612, sealhulgas 409 patsienti vanuses <18 aasta; ravimiga kokkupuute kestuse mediaan 36,8 kuud [vahemik 0,5 kuni 83,2]).
English: The active substance is everolimus.
Estonian: Toimeaine on everoliimus.
English: verapamil or diltiazem, used to treat heart conditions or high blood pressure.
Estonian: verapamiil või diltiaseem, mida kasutatakse südamehaiguste või kõrgvererõhu raviks.
English: Summary of the safety profile
Estonian: Ohutusalaste andmete kokkuvõte
English: Non-infectious pneumonitis is a class effect of rapamycin derivatives, including everolimus.
Estonian: Mittenakkuslik pneumoniit on rapamütsiini derivaatide klassi ravimitele, sealhulgas everoliimusele omane kõrvaltoime.
English: Higher proportions of responders were evident for all response categories in the Votubia LT and HT arms relative to placebo (Figure 1).
Estonian: Ravivastusega patsientide suurem osakaal oli täheldatav kõigis ravivastuse kategooriates Votubia LT ja HT rühmas võrreldes platseeboga (joonis 1).
English: 6 to <12 years n=37
Estonian: 6 kuni <12 aastat n=37
English: Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (see section 4.4).
Estonian: Patsientidel, kes kasutavad samal ajal AKE inhibiitorit (nt ramipriil), võib olla suurem angioödeemi tekkimise risk (vt lõik 4.4).
English: Blockage or obstruction of a blood vessel (vein) in the leg (deep vein thrombosis).
Estonian: Ummistus või takistus jalaveresoones (veenis) (süvaveeni tromboos).
English: Patients <18 years of age:
Estonian: Maksakahjustus <18-aastased patsiendid:
English: Concomitant treatment of Votubia and potent inhibitors is not recommended.
Estonian: Votubia ja tugevate inhibiitorite samaaegne kasutamine ei ole soovitatav.
English: If you receive Votubia for the treatment of TSC with angiomyolipoma of the kidney, the usual dose is 10 mg, to be taken once daily.
Estonian: Kui te saate Votubiat tuberoosse skleroosi kompleksiga kaasneva neeru angiomüolipoomi raviks, on tavaline annus 10 mg ööpäevas.
English: A total of 49 out of 137 patients (36%) aged <6 years had Grade 3/4 infections, compared to 53 out of 272 patients (19%) aged 6 to <18 years and 27 out of 203 patients (13%) aged ≥18 years.
Estonian: raskusastme infektsioonid esinesid <6 aasta vanuste patsientide seas kokku 49 patsiendil 137-st (36%), 6 kuni <18-aastaste patsientide seas 53 patsiendil 272-st (19%) ning ≥18-aastaste patsientide seas 27 patsiendil 203-st (13%).
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%).
Estonian: Onkoloogiliste patsientide hulgas oli kõrvaltoimete tõttu everoliimus-ravi katkestamisi rohkem ≥65-aastaste hulgas (20% versus 13%).
English: In patients with SEGA, the geometric mean Cmin values normalised to mg/m dose in patients aged <10 years and 10-18 years were lower by 54% and 40%, respectively, than those observed in adults (>18 years of age), suggesting that everolimus clearance was higher in younger patients.
Estonian: Subependümaalse hiidrakulise astrotsütoomiga patsientidel oli Cmin geomeetrilise keskmise väärtused normaliseerituna mg/m annusele <10-aastastel ja 10...18-aastastel vastavalt 54% ja 40% madalamad kui uuritud täiskasvanutel (>18-aastased), mis viitab nooremate patsientide puhul everoliimuse suuremale kliirensile.
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.
Estonian: Põhifaasis oli kõigis kolmes rühmas ravi kestuse mediaan 18 nädalat, arvestades nii põhifaasi kui pikendusfaasi, oli ravi kestuse mediaan 90 nädalat (21 kuud).
English: Discontinue Votubia.
Estonian: Katkestada Votubia-ravi.
English: There was evidence of reversibility.
Estonian: See protsess oli pöörduv.
English: Patients initially treated with placebo were allowed to cross over to everolimus at the time of angiomyolipoma progression and upon recognition that treatment with everolimus was superior to treatment with placebo.
Estonian: Algselt platseebot saanud patsientidel lubati üle minna everoliimuse rühma, kui angiomüolipoom progresseerus ning kui selgus, et ravi everoliimusega on platseebost efektiivsem.
English: Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) (see section 4.5).
Estonian: Patsientidel, kes kasutavad samal ajal AKE inhibiitorit (nt ramipriil), võib olla suurem angioödeemi tekkimise risk (nt hingamisteede ja keele turse, koos hingamisraskusega või ilma) (vt lõik 4.5).
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis, candidiasis or pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) and viral infections including reactivation of hepatitis B virus, have been described in patients taking everolimus.
Estonian: Everoliimust võtvatel patsientidel, on kirjeldatud lokaalseid ja süsteemseid nakkusi, sealhulgas kopsupõletikku, teisi bakteriaalseid nakkusi, invasiivseid seennakkusi, nagu näiteks aspergilloosi, kandidiaasi või pneumocystis jirovecii (carinii) põhjustatud pneumooniat (PJP, PCP) ja viirusinfektsioone, sealhulgas B-hepatiidi viiruse reaktiveerumist.
English: The most frequent grade 3-4 adverse reactions (incidence ≥1%) were pneumonia, stomatitis, amenorrhoea, neutropenia, pyrexia, menstruation irregular, hypophosphataemia, diarrhoea, and cellulitis.
Estonian: Kõige sagedamini esinenud 3. ja 4. astme kõrvaltoimed (sagedus ≥1%) olid pneumoonia, stomatiit, amenorröa, neutropeenia, püreksia, ebaregulaarne menstruatsioonitsükkel, hüpofosfateemia, kõhulahtisus ja tselluliit.
English: ≥18 years b n=21
Estonian: ≥ 18 aastat n=21
English: The filled syringe should be placed into a container (with the tip pointing up) for 3 minutes, until the Votubia dispersible tablets are in suspension.
Estonian: Asetada täidetud süstal anumasse (süstlaots ülespoole) 3 minutiks kuni Votubia dispergeeruvad tabletid on muutunud suspensiooniks.
English: Dispersible tablet.
Estonian: Dispergeeruv tablett.
English: After preparation the suspension must be taken straight away.
Estonian: Pärast valmistamist kasutage suspensioon ära koheselt.
English: The extent of absorption of everolimus through topical exposure is not known.
Estonian: Everoliimuse imendumise määr paiksel kokkupuutel on teadmata.
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.
Estonian: Põhifaasi lõpus säilis 2 kuni <11-aastaste patsientide üldine elukvaliteet (mõõdetuna lapseea epilepsia elukvaliteedi küsimustiku [Quality Of Life in Childhood Epilepsy Questionnaire, QOLCE] üldskooriga, hinnates keskmist muutust võrreldes algväärtusega) nii mõlemas Votubia ravirühmas kui ka platseeborühmas.
English: In healthy subjects taking a single 9 mg dose (3 x 3 mg) of Votubia dispersible tablets in suspension, high fat meals reduced AUC by 11.7% and the peak blood concentration Cmax by 59.8%.
Estonian: Tervetel isikutel, kes võtsid üksikannusena 9 mg (3 x 3 mg) Votubia dispergeeruvaid tablette suspensioonina, vähendas suure rasvasisaldusega toit AUC väärtust 11,7% ja maksimaalset kontsentratsiooni veres Cmax 59,8%.
English: If toxicity becomes intolerable, temporary dose interruption until recovery to Grade 1.
Estonian: Kui mürgistus muutub talumatuks, tuleb ravi ajutiselt katkestada kuni on toimunud paranemine ≤1.
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.
Estonian: Patsientidele, kellel on tuberoosse skleroosi kompleksiga kaasnev subependümaalne hiidrakuline astrotsütoom ja kes ei ole võimelised tablette alla neelama, tuleb Votubia tablett (tabletid) vahetult enne manustamist umbes 30 ml vees kergelt klaasis segades lahustada kuni tabletid on täielikult dispergeerunud (umbes 7 min).
English: Excess amount of gas in the bowels (flatulence)
Estonian: Üleliigselt gaasi soolestikus (kõhupuhitus)
English: If dose reduction is required, the recommended dose is approximately 50% lower than the daily dose previously administered.
Estonian: Kui on vajalik annuse vähendamine, on soovitatav annus ligikaudu 50% väiksem kui eelnevalt manustatud ööpäevane annus.
English: 75% resp. 75 to <100
Estonian: 75% vastus 75 kuni <100
English: The estimated angiomyolipoma progression-free rates at 24 months and 48 months were 91.6% and 83.1%, respectively.
Estonian: Hinnanguline progressioonivaba aeg oli 24 kuud ja 48 kuud vastavalt 91,6%-l ja 83,1%-l patsientidest.
English: Final analysis includes patients who crossed over from the placebo group; median duration of exposure to everolimus of 204.1 weeks
Estonian: Lõplikku analüüsi kaasati patsiendid, kes toodi üle platseeborühmast; everoliimusravi mediaankestus oli 204,1 nädalat
English: 12 to <18 years n=26
Estonian: 12 kuni <18 aastat n=26
English: Votubia may increase blood sugar levels and worsen diabetes mellitus.
Estonian: Votubia võib põhjustada veresuhkru taseme tõusu ja suhkurtõve süvenemist.
English: In patients with advanced solid tumours, peak everolimus concentrations (Cmax) are reached at a median time of 1 hour after daily administration of 5 and 10 mg everolimus under fasting conditions or with a light fat-free snack.
Estonian: Kaugelearenenud tuumoritega patsientidel saabub everoliimuse maksimaalne plasmakontsentratsioon (Cmax) keskmiselt ühe tunni jooksul pärast 5 ja 10 mg everoliimuse manustamist iga päev tühja kõhuga või kerge rasvavaba einega.
English: Keep the medicine out of the reach of children.
Estonian: Ravimit hoidke lastele kättesaamatus kohas.
English: Sustained reductions were evident at week 24, 41.9% (31/74) of patients had ≥50% reductions and 78.4% (58/74) of patients had ≥30% reductions in SEGA volume.
Estonian: Püsiv vähenemine oli täheldatav 24. nädalal: 41,9% (31/74) patsientidest saavutas ≥50% mahu vähenemise ning 78,4% patsientidest ≥30% subependümaalse hiidrakulise astrotsütoomi mahu vähenemise.
English: Only use water (drinkable tap water or non-sparkling bottled water) to prepare the oral suspension.
Estonian: Suspensiooni valmistamiseks kasutage ainult vett (joodav kraanivesi või gaseerimata pudelivesi).
English: Table 2 Effects of other active substances on everolimus
Estonian: Tabel 2 Teiste toimeainete toime everoliimusele
English: Once a stable dose is attained, trough concentrations should be monitored every 3 to 6 months in patients with changing body surface area, or every 6 to 12 months in patients with stable body surface area, for the duration of treatment.
Estonian: Niipea kui stabiilne annus on saavutatud, tuleb minimaalse kontsentratsiooni jälgimist jätkata muutuva kehapindalaga patsientidel iga 3 kuni 6 kuu tagant või stabiilse kehapindalaga patsientidel iga 6 kuni 12 kuu tagant kogu raviperioodi jooksul.
English: The same pharmaceutical form must be used consistently, as appropriate for the indication being treated.
Estonian: Vastavalt näidustusele tuleb püsivalt kasutada sama ravimvormi.
English: • The co-administration of the PgP inhibitor, cyclosporine, enhances the exposure of everolimus in the brain cortex, which is consistent with the inhibition of PgP at the blood-brain barrier.
Estonian: • PgP inhibiitori, tsüklosporiiniga, koosmanustamine suurendab everoliimuse ekspositsiooni ajukoores, mis vastab PgP inhibitsioonile hematoentsefaalbarjääris.
English: Votubia is not to be used in children below the age of 2 years with TSC and seizures.
Estonian: Votubiat ei tohi kasutada alla 2-aastastel lastel, kellel on tuberoosne skleroosi kompleks ja hood.
English: • Moderate hepatic impairment (Child-Pugh B): 50% of the recommended starting dose calculated based on BSA (rounded to the nearest strength)
Estonian: • Mõõdukas maksakahjustus (Child-Pugh klass B): 50% soovituslikust algannusest, mis on arvutatud kehapinna (ümardatud lähima suuruseni) järgi
English: However, oral doses of everolimus in female rats at ≥ 0.1 mg/kg (approximately 4% of the AUC0-24h in patients receiving the 10 mg daily dose) resulted in increases in pre-implantation loss.
Estonian: Siiski sagenes implantatsioonieelne loote kaotus emastel rottidel, kes said ≥0,1 mg/kg (ligikaudu 4% AUC0-24h patsientidel, kes said päevas 10 mg annuse).
English: Caregivers are advised to avoid contact with suspensions of Votubia dispersible tablets.
Estonian: Hooldajatel soovitatakse vältida kokkupuudet Votubia dispergeeruvate tablettide suspensiooniga.
English: In healthy subjects, high fat meals reduced systemic exposure to Votubia 10 mg tablets (as measured by AUC) by 22% and the peak blood concentration Cmax by 54%.
Estonian: Tervetel isikutel vähendas suure rasvasisaldusega toit 10 mg Votubia tablettide süsteemset toimet (AUC järgi) 22% ja maksimaalset kontsentratsiooni veres Cmax 54%.
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.
Estonian: 22 subependümaalse hiidrakulise astrotsütoomiga patsienti 28-st, keda uuriti olulise tähtsusega II faasi uuringus, olid alla 18 aasta vanused ja 101 subependümaalse hiidrakulise astrotsütoomiga patsienti 117-st, keda uuriti olulise tähtsusega III faasi uuringus, olid alla 18 aasta vanused.
English: The recommended starting dose for Votubia for the treatment of patients with SEGA is 4.5 mg/m 2.
Estonian: Votubia soovituslik algannus subependümaalse hiidrakulise astrotsütoomiga patsientidele on 4,5 mg/m2.
English: Responders - n (%) Response rate 95% CI
Estonian: Ravivastusega- n (%) Ravivastuse määr 95% CI
English: This dose of Votubia is predicted to adjust the AUC to the range observed without inducers.
Estonian: See Votubia annus peaks tagama AUC väärtused vahemikus, mida täheldatakse indutseerijate samaaegse manustamiseta.
English: Monitoring of blood cholesterol and triglycerides prior to the start of Votubia therapy and periodically thereafter, as well as management with appropriate medical therapy, is also recommended.
Estonian: Soovitatav on vere kolesterooli- ja triglütseriidide taseme jälgimine enne ravi alustamist Votubiaga ja perioodiliselt ravi ajal ning samuti on soovitatav asjakohase ravi rakendamine.
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.
Estonian: 170 kaugelearenenud tuumoriga patsiendi populatsiooni farmakokineetilises analüüsis ei tuvastatud kreatiniini kliirensi (25...178 ml/min) olulist mõju everoliimuse CL/F-ile.
English: The safety and efficacy of Votubia in children aged 0 to 18 years with renal angiomyolipoma associated with TSC in the absence of SEGA have not been established.
Estonian: Votubia ohutus ja efektiivsus lastel vanuses 0 kuni 18 aastat, kellel on tuberoosse skleroosi kompleksiga kaasnev neeru angiomüolipoom ja ei ole subependümaalset hiidrakulist astrotsütoomi, ei ole tõestatud.
English: Potent CYP3A4/PgP inhibitors Ketoconazole
Estonian: Tugevad CYP3A4/PgP inhibiitorid Ketokonasool
English: Take Votubia dispersible tablets once a day.
Estonian: Võtke Votubia dispergeeruvaid tablette üks kord päevas.
English: The following side effects have been reported in patients taking everolimus for the treatment of conditions other than TSC:
Estonian: Järgnevatest kõrvaltoimetest on teatatud patsientidel, kes võtavad everoliimust muude seisundite kui tuberoosse skleroosi kompleksi raviks:
English: Open the blister just before taking Votubia dispersible tablets.
Estonian: Avage blisterpakend vahetult enne Votubia dispergeeruvate tablettide võtmist.
English: Light fat meals reduced AUC by 29.5% and Cmax by 50.2%.
Estonian: Vähese rasvasisaldusega toidud vähendasid AUC 29,5% ja Cmax
English: Table 3 Effects of other active substances on everolimus
Estonian: Tabel 3 Teiste toimeainete toime everoliimusele
English: Toxicity study with juvenile monkeys did not show any relevant toxicity.
Estonian: Noortel ahvidel teostatud toksilisuse uuringutes olulist toksilisust ei täheldatud.
English: Median Cmin normalised to mg/m dose was lower for the younger age groups, indicating that everolimus clearance (normalised to body surface area) was higher in younger patients.
Estonian: Annuse mg/m järgi normaliseeritud Cmin mediaanväärtused oli nooremates vanuserühmades madalamad, mis viitab everoliimuse suuremale kliirensile (vastavalt kehapindala normaliseeritud) nooremas vanuserühmas.
English: Take Votubia dispersible tablets as a suspension only.
Estonian: Votubia dispergeeruvaid tablette võtta ainult suspensioonina.
English: The incidence of skeletal variations and malformations (e.g. sternal cleft) was increased at 0.3 and 0.9 mg/kg.
Estonian: 0,3 ja 0,9 mg/kg manustamisel suurenes skeletimuutuste ja väärarengute (nt sternumi lõhestumine) esinemissagedus.
English: In vitro, everolimus is a competitive inhibitor of CYP3A4 and a mixed inhibitor of CYP2D6.
Estonian: In vitro katsed on näidanud, et everoliimus on CYP 3A4 konkureeriv inhibiitor ja CYP2D6 segatüüpi inhibiitor.
English: Removing air
Estonian: Õhu eemaldamine
English: Consider interruption of therapy until symptoms improve to Grade 1.
Estonian: Kaaluda ravi katkestamist kuni sümptomid paranevad 1.
English: Additional adverse reactions of relevance observed in oncology clinical studies and post-marketing spontaneous reports, were cardiac failure, pulmonary embolism, deep vein thrombosis, impaired wound healing and hyperglycaemia.
Estonian: Teised olulised onkoloogilistest kliinilistest uuringutest ja turuletulekujärgsel perioodil spontaanselt teatatud kõrvaltoimed olid südamepuudulikkus, kopsuemboolia, süvaveeni tromboos, halvenenud haavade paranemine ja hüperglükeemia.
English: There was a significant correlation between AUC0-τ and pre-dose trough concentration at steady-state.
Estonian: AUC0-τ ja annuse-eelse baaskontsentratsiooni vahel esines püsiseisundis oluline korrelatsioon.
English: Hepatitis B reactivation has been observed in some patients taking everolimus.
Estonian: Mõnedel everoliimust võtvatel patsientidel on täheldatud B-hepatiidi reaktiveerumist.
English: Grade 2 (≥1x10
Estonian: 2. aste (≥1x10
English: If you have taken too much Votubia, or if someone else accidentally takes your tablets, see a doctor or go to a hospital immediately.
Estonian: Kui te võtate Votubiat rohkem kui ette nähtud Kui te võtate Votubiat liiga palju või kui keegi teine võtab kogemata teie tablette, pöörduge otsekohe arsti poole või minge haiglasse.
English: ciclosporin, a medicine used to stop the body from rejecting organ transplants.
Estonian: tsüklosporiin, ravim, mida kasutatakse siirdatud elundite äratõuke vältimiseks.
English: Place them into the barrel of the oral syringe straight away.
Estonian: Asetage need koheselt suusüstla silindrisse.
English: Individualised dosing should be titrated by increasing the dose by increments of 2.5 mg to attain the target trough concentration for optimal clinical response.
Estonian: Individuaalse annuse tiitrimiseks tuleb annust suurendada 2,5 mg kaupa, et saavutada minimaalne sihtkontsentratsioon optimaalse kliinilise vastuse jaoks.
English: Votubia may elevate cholesterol and/or other blood fats.
Estonian: Votubia võib põhjustada kolesterooli ja/või teiste vererasvade sisalduse suurenemist.
English: In total, 28 patients received treatment with Votubia; median age was 11 years (range 3 to 34), 61% male, 86% Caucasian.
Estonian: Kokku raviti Votubiaga 28 patsienti, kelle keskmine vanus oli 11 aastat (vahemikus 3...34), kellest 61% olid meessoost ja 86% valge rassi esindajad.
English: Patients with seizures receiving concomitant strong CYP3A4 inducers (e.g., enzyme inducing antiepileptics carbamazepine, phenobarbital, and phenytoin) at the start of treatment with everolimus require an increased starting dose to attain trough concentrations of 5 to 15 ng/ml (see Table 1).
Estonian: Hoogudega patsiendid, kes saavad ravi alustamisel everoliimusega samaaegselt tugevaid CYP3A4 indutseerijaid (nt ensüümi indutseerivad epilepsiavastased ravimid karbamasepiin, fenobarbitaal ja fenütoiin), vajavad suuremat algannust minimaalse kontsentratsiooni 5…15 ng/ml saavutamiseks (vt tabel 1).
English: How to take Votubia
Estonian: Kuidas Votubiat võtta
English: Renal impairment No dose adjustment is required (see section 5.2).
Estonian: Neerukahjustus Annuse kohandamine ei ole vajalik (vt lõik 5.2).