FrancophonIA/ELRC3.0 huggingface dataset:
English: During the double-blind period, reduction of SEGA volume was evident within the initial 12 weeks of Votubia treatment: 29.7% (22/74) of patients had ≥50% reductions in volume and 73.0% (54/74) had ≥30% reductions in volume.
Maltese: Matul il-perjodu double-blind, it-tnaqqis tal-volum ta' SEGA kien evidenti fl-ewwel 12-il ġimgħa mittrattament b'Votubia: 29.7% (22/74) tal-pazjenti kellhom tnaqqis ta' ≥50% fil-volum u 73.0% (54/74) kellhom tnaqqis ta' ≥30% fil-volum.
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.
Maltese: Simulazzjonijiet tal-mudell farmakokinetiku fil-popolazzjoni wrew li d-doża inizjali ta' 7 mg/m tkun meħtieġa sabiex jinkiseb Cmin meta tingħata doża ta' bejn 5 u 15 ng/ml f'pazjenti iżgħar minn 3 snin.
English: Best overall angiomyolipoma response - % Response
Maltese: L-aħjar rispons tal-anġjomijolipoma globalment - %
English: At the primary analysis, skin lesion response rates of 26.0% (95% CI: 16.6, 37.2) for the Votubia arm and 0% (95% CI: 0.0, 9.5) for the placebo arm were observed (p=0.0002).
Maltese: 0% (95% CI: 16.6, 37.2) fost il-grupp mogħti Votubia u 0% (95% CI: 0.0, 9.5) fost il-grupp mogħti plaċebo (p=0.0002).
English: Each tablet contains 2.5 mg everolimus.
Maltese: Kull pillola fiha 2.5 mg everolimus.
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.
Maltese: Endpoints sekondarji kienu jinkludu nuqqas ta' atakki epilettiċi, proporzjon ta' pazjenti b'>25% tnaqqis fil-frekwenza tal-atakki epilettiċi mil-linja bażi, distribuzzjoni tat-tnaqqis mil-linja bażi filfrekwenza tal-atakki epilettiċi (≤-25%, >-25% sa <25%; ≥25% sa <50%;
English: Each tablet contains 10 mg everolimus.
Maltese: Kull pillola fiha 10 mg everolimus.
English: The best overall SEGA response rate had increased to 57.7% (95% CI: 47.9, 67.0) at the final analysis.
Maltese: L-aħjar rata ta' rispons sħiħ ta' SEGA żdiedet għal 57.7% (95% CI: 47.
English: The median duration of blinded study treatment was 52.2 weeks (range 24 to 89) for patients receiving Votubia and 46.6 weeks (range 14 to 88) for those receiving placebo.
Maltese: Id-dewmien medjan tal-istudju bi trattament blinded kien ta' 52.2 ġimgħat (medda minn 24 sa 89) għal pazjenti mogħtija Votubia u 46.6 ġimgħat (medda minn 14 sa 88) għal dawk mogħtija plaċebo.
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.
Maltese: Sitt metaboliti ewlenin ta' everolimus kienu osservati fiddemm tal-bniedem, inklużi tliet metaboliti monoidroksilati, żewġ prodotti idrolitiċi ċirku miftuħ u konjugat phosphatidylcholine ta' everolimus.
English: 95% confidence interval
Maltese: 95% CI
English: Yes
Maltese: JIS
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.
Maltese: Is-sigurtà, it-tollerabbilità u l-farmakokinetika ta' Votubia ġew stmati f'żewġ studji b'doża waħda ta' pilloli Votubia mill-ħalq fi 8 u 34 individwu adult b'indeboliment fil-funzjoni tal-fwied meta mqabbla ma' individwi b'funzjoni normali tal-fwied.
English: The cumulative median duration exposure to Votubia (361 patients who took at least one dose of everolimus) was 30.4 months (range 0.5 to 48.8).
Maltese: L-esponiment b'dewmien medjan kumulattiv għal Votubia (361 pazjent li ħadu tal-inqas doża waħda ta' everolimus) kien ta' 30.4 xhur (firxa 0.5 sa 48.8).
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors
Maltese: L-użu flimkien ta' inibituri tal-enzima li tikkonverti l-anġjotensin (ACE)
English: Temporary dose interruption until recovery to Grade 1 (≥75x10
Maltese: Interrompi d-doża temporanjament sakemm ikun hemm titjib f' Grad 1 (≥75x10
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).
Maltese: Ir-rati ta' rispons kienu ta' 34.6% (95% CI: 24.2, 46.2) fost il-grupp mogħti Votubia mqabbel ma' 0% (95% CI: 0.0, 0.0) fost il-grupp mogħti plaċebo (Tabella 6).
English: Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal derivattivi ta' rapamycin jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Progressions were observed in 3.8% of patients in the everolimus arm compared with 20.5% in the placebo arm.
Maltese: Il-progressjonijiet kienu osservati fi 3.8% tal-pazjenti fil-grupp mogħti everolimus imqabbel mal-grupp 20.
English: Cmax is dose-proportional between 5 and 10 mg. tmax occurs at 1 to 2 hours post-dose.
Maltese: Cmax hija fi proporzjon mad-doża bejn id-dożi ta' 5 u 10 mg.
English: Cases of pneumocystis jirovecii (carinii) pneumonia (PJP, PCP), some with fatal outcome, have been reported in patients who received everolimus.
Maltese: Każijiet ta' pulmonite kkawżata minn pneumocystis jirovecii (carinii) (PJP, PCP), uħud b'riżultat fatali, kienu rrappurtati f'pazjenti li rċevew everolimus.
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.
Maltese: III li tqabbel it-trattament aġġuntiv ta' espożizzjoni baxxa u għolja ta' everolimus (l-inqas medda [LT] ta' 3-7 ng/ml [n=117] u l-ogħla l-inqas [HT] medda ta' 9-15 ng/ml [n=130]) kontra l-plaċebo (n=119), f'pazjenti b'TSC u attakki epilettiċi refrattorji tat-tip parzjali mogħtija minn 1 sa 3 mediċini antiepilettiċi.
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).
Maltese: Ir-rati ta' rispons kienu ta' 34.6% (95% CI: 24.2, 46.2) fost il-grupp mogħti Votubia mqabbel ma' 0% (95% CI: 0.0, 0.0) fost il-grupp mogħti plaċebo (Tabella 7).
English: In order to achieve a target concentration above the lower Cmin limit of 5 ng/ml, e.g. 8 ng/ml, the new everolimus dose would be 8 mg (an increase of 4 mg from the current daily dose).
Maltese: Sabiex tinkiseb il-konċentrazzjoni mixtieqa li taqbeż l-inqas limitu tas-Cmin ta' 5 ng/ml, eż. 8 ng/ml, id-doża l-ġdida ta' everolimus għandha tkun ta' 8 mg (żieda ta' 4 mg mid-doża kurrenti ta' kuljum).
English: In order to achieve a target concentration above the lower Cmin limit of 5 ng/ml, e.g. 8 ng/ml, the new everolimus dose would be 5 mg (an increase of 2.5 mg from the current daily dose).
Maltese: Sabiex tinkiseb il-konċentrazzjoni mixtieqa li taqbeż l-inqas limitu tas-Cmin ta' 5 ng/ml, eż. 8 ng/ml, id-doża l-ġdida ta' everolimus għandha tkun ta' 5 mg (żieda ta' 2.5 mg mid-doża kurrenti ta' kuljum).
English: Hyperglycaemia has been reported in patients taking Votubia (see section 4.8).
Maltese: Ipergliċemija kienet rrappurtata f'pazjenti li jieħdu Votubia (ara sezzjoni 4.8).
English: Angiomyolipoma progressions were observed in 14.3% of the patients.
Maltese: Il-progressjonijiet tal-anġjomijolipoma ġew irreġistrati f'14.3% tal-pazjenti.
English: EXIST-1 (Study CRAD001M2301), a randomised, double-blind, multicentre phase III study of Votubia versus placebo, was conducted in patients with SEGA, irrespective of age.
Maltese: L-istudju dwar Votubia kontra l-plaċebo f'fażi III EXIST-1 (Studju CRAD001M2301), randomizzat, double-blind, multiċentriku, sar fost pazjenti b'SEGA, irrispettivament mill-età.
English: Overactivation of mTOR results in neuronal dysplasia, aberrant axonogenesis and dendrite formation, increased excitatory synaptic currents, reduced myelination, and disruption of the cortical laminar structure causing abnormalities in neuronal development and function.
Maltese: L-attivazzjoni eċċessiva tal-mTOR twassal għal displasja newronali, axonogenesis anormali u formazzjoni ta' dendrite, żieda fil-kurrenti sinattiċi eċċittatorji, tnaqqis tal-mjelinizzazzjoni, u disturb tal-istruttura laminari kortikali li twassal għal anormalitajiet fl-iżvilupp u l-funzjoni newronali.
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 tablets.
Maltese: Pakketti li fihom 10 x 1, 30 x 1 jew 100 x 1 pillola.
English: The estimated angiomyolipoma progression-free rates at 24 months and 48 months were 91.6% and 83.1%, respectively.
Maltese: L-istima tar-rati mingħajr progressjoni tal-anġjomijolipoma f'24 xahar u fi 48 xahar kienu 91.6% u 83.1%, rispettivament.
English: In patients with TSC, treatment with everolimus increases VEGF-A and decreases VEGF-D levels.
Maltese: F'pazjenti li għandhom TSC, it-trattament b'everolimus iżid il-livelli ta' VEGF-A u jnaqqas il-livelli ta' VEGF-D.
English: If toxicity recurs at Grade 3, consider discontinuation.
Maltese: Jekk jerġa' jkun hemm tossiċità fi grad 3, ikkunsidra li tieqaf.
English: Table 5 EXIST-2 - Angiomyolipoma response rates by time-averaged Cmin category, at primary analysis
Maltese: EXIST-2 - Rati ta' rispons ta' anġjomijolipoma skont il-kategorija żmien-Cmin medja, fl-analiżi primarja
English: Temporary dose interruption until recovery to Grade 1.
Maltese: Waqqaf temporanjament id-doża sakemm dak li jkun ma jirkuprax għal  Grad 1.
English: Table 4 EXIST-2 - Angiomyolipoma response
Maltese: EXIST-2 - Rispons tal-anġjiomijolipoma
English: Month 24 n=24
Maltese: Xahar n=24
English: • A dose-dependent brain penetration of everolimus, which is consistent with the hypothesis of saturation of an efflux pump present in the brain capillary endothelial cells.
Maltese: • Penetrazzjoni ta' everolimus fil-moħħ li tiddependi mid-doża, u dan hu konsistenti mal-ipoteżi ta' saturazzjoni tal-pompa ta' effluss preżenti fiċ-ċelloli kapillari endoteljali tal-moħħ.
English: Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets everolimus
Maltese: Votubia 1 mg pilloli li jinxterdu Votubia 2 mg pilloli li jinxterdu Votubia 3 mg pilloli li jinxterdu Votubia 5 mg pilloli li jinxterdu everolimus
English: The robustness and consistency of the primary analysis were supported by the: change in primary SEGA volume as per local investigator assessment (p<0.001), with 75.0% and 39.3% of patients experiencing reductions of ≥30% and ≥50%, respectively change in total SEGA volume as per independent central review (p<0.001) or local investigator assessment (p<0.001).
Maltese: Il-qawwa u l-konsistenza tal-analiżi primarja twieżnu bil-: bidla fil-volum primarju ta' SEGA skont l-evalwazzjoni tal-investigatur lokali (p<0.001), b'75.0% u 39.3% tal-pazjenti jesperjenzaw tnaqqis ta' ≥30% u ≥50%, rispettivament tibdil fil-volum totali ta' SEGA skont konsulta ċentrali indipendenti (p<0.
English: 94.0% had skin lesions at baseline and 37.6% had target renal angiomyolipoma lesions (at least one angiomyolipoma ≥1 cm in longest diameter).
Maltese: 94.0% kellhom feriti fil-ġilda fil-linja bażi u 37.6% kellhom leżjonijiet ta' anġjiomijolipoma tal-fwied mixtieqa (mill-inqas anġjiomijolipoma waħda ta' ≥1 ċm fl-itwal dijametru).
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]).
Maltese: II jagħtu sehemhom fil-profil ta' sigurtà ġenerali ta' Votubia (n=612, inkuż 409 pazjenti li għandhom <18-il sena; dewmien medjan ta' esponiment ta' 36.8 xhur [firxa 0.5 sa 83.2]).
English: Phase III study in patients with TSC and refractory seizures EXIST-3 (Study CRAD001M2304), a randomised, double-blind, multicentre, three-arm, parallel-group phase III study of Votubia versus placebo as adjunctive therapy was conducted in TSC patients with refractory partial-onset seizures.
Maltese: III bi gruppi paralleli, randomizzat, double-blind, multiċentriku, fost tliet gruppi b'Votubia kontra l-plaċebo bħala terapija miżjuda twettaq fost pazjenti b'attakki epilettiċi refrattorji parzjali.
English: Dry skin, acneiform dermatitis, pruritus, alopecia Uncommon Angioedema Musculoskeletal and connective tissue disorders Uncommon Rhabdomyolysis Renal and urinary disorders Common
Maltese: Ġilda xotta, dermatite akneiformi, ħakk, allopeċja Mhux komuni Anġjoedima Disturbi muskolu-skelettriċi u tat-tessuti konnettivi
English: Votubia is available in two pharmaceutical forms: tablets and dispersible tablets.
Maltese: Votubia hu disponibbli f'żewġ forom farmaċewtiċi: pilloli u pilloli li jinxterdu.
English: Everolimus appeared to spontaneously exacerbate background diseases (chronic myocarditis in rats, coxsackie virus infection of plasma and heart in monkeys, coccidian infestation of the gastrointestinal tract in minipigs, skin lesions in mice and monkeys).
Maltese: Everolimus deher li jħarrax b'mod spontanju mard li jkun hemm diġà (mijokardite kronika fil-firien, infezzjoni tal-plażma u l-qalb bil-virus coxsackie fix-xadini, infestazzjoni b'coccidia fl-apparat gastrointestinali tal-ħnieżer żgħar, ġrieħi fil-ġilda fil-ġrieden u x-xadini).
English: Everolimus is not considered dialysable to any relevant degree (less than 10% was removed within 6 hours of haemodialysis).
Maltese: Everolimus mhuwiex meqjus bħala dijaliżabbli fl-ebda grad relevanti (anqas minn 10% tneħħa fi żmien 6 sigħat ta' emodijaliżi).
English: Of the enrolled patients, 79.5% had bilateral SEGAs, 42.7% had ≥2 target SEGA lesions, 25.6% had inferior growth, 9.4% had evidence of deep parenchymal invasion, 6.8% had radiographic evidence of hydrocephalus, and 6.8% had undergone prior SEGA-related surgery.
Maltese: 6% kellhom tkabbir inferjuri, 9.4% kellhom evidenza ta' invażjoni parenkimali profonda, 6.8% kellhom evidenza radjografika ta' idroċefalus, u 6.8% kellhom operazzjoni b'rabta ma' SEGA fl-imgħoddi.
English: Avoid the use of concomitant potent CYP3A4 inducers.
Maltese: Evita li tuża indutturi qawwija ta' CYP3A4 flimkien.
English: In the first study, the average AUC of everolimus in 8 subjects with moderate hepatic impairment (Child-Pugh B) was twice that found in 8 subjects with normal hepatic function.
Maltese: Fl-ewwel studju, l-AUC medja ta' everolimus fi 8 individwi b'indeboliment moderat tal-funzjoni talfwied (Child-Pugh B) kienet id-doppju ta' dik osservata fi 8 individwi b'funzjoni normali tal-fwied.
English: The cumulative median duration of exposure to Votubia (112 patients who took at least one dose of everolimus) was 46.9 months (range 0.5 to 63.9).
Maltese: Id-dewmien medjan kumulattiv tal-esponiment għal Votubia (112-il pazjent li ħadu tal-inqas doża waħda ta' everolimus) kien ta' 46.9 xhur (firxa 0.5 sa 63.9).
English: Laboratory tests and monitoring
Maltese: Testijiet tal-laboratorju u monitoraġġ
English: The use of live vaccines should be avoided during treatment with Votubia (see section 4.5).
Maltese: L-użu ta' tilqim b'mikrobi ħajjin għandu jiġi evitat waqt kura b'Votubia (ara sezzjoni 4.5).
English: In a post-marketing single-arm study in postmenopausal women with advanced breast cancer (N=92), topical treatment with dexamethasone 0.5 mg/5 ml alcohol-free oral solution was administered as a mouthwash (4 times daily for the initial 8 weeks of treatment) to patients at the time of initiating treatment with Afinitor (everolimus, 10 mg/day) plus exemestane (25 mg/day) to reduce the incidence and severity of stomatitis.
Maltese: Skont studju magħmul wara t-tqegħid tal-prodott fis-suq fost grupp wieħed ta' nisa li kellhom kanċer fis-sider avvanzat wara l-menopawża (N=92), ingħata trattament topiku b'dexamethasone 0.5 mg/5ml soluzzjoni orali mingħajr alkoħol mogħtija bħala likwidu għat-tlaħliħ tal-ħalq (4 darbiet kuljum għall-ewwel 8 ġimgħat ta' trattament) lil pazjenti mat-tnedija tat-trattament b'Afinitor (everolimus, 10 mg/jum) flimkien ma' exemestane (25 mg/jum) sabiex tonqos l-inċidenza u l-gravità ta' stomatite.
English: Votubia 2.5 mg tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Maltese: Il-pilloli Votubia 2.5 mg huma disponibbli f'pakketti li fihom 10 x 1, 30 x 1 jew 100 x 1 pillola f'folji mtaqqbin ta' doża waħda ta' 10 x 1 pillola kull waħda.
English: An interaction study in healthy subjects demonstrated that co-administration of an oral dose of midazolam, a sensitive CYP3A substrate probe, with everolimus resulted in a 25% increase in midazolam Cmax and a 30% increase in midazolam AUC(0-inf).
Maltese: Studju ta' interazzjoni f'suġġetti b'saħħithom wera li l-għoti ta' doża ta' midazolam mill-ħalq, sonda ta' substrat ta' CYP3A, sensittiv, ma' everolimus wassal għal żieda ta' 25% ta' midazolam fis-Cmax u għal żieda ta' 30% flAUC(0-inf) ta' midazolam.
English: Votubia 10 mg tablets are white to slightly yellowish, elongated tablets.
Maltese: Votubia 10 mg pilloli huma minn bojod sa kemxejn sofor, tawwalin.
English: Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)
Maltese: Anġjomijolipoma renali assoċjata ma' kumpless sklerożi tuberoża (TSC)
English: Abdominal pain, nausea, vomiting, diarrhoea, swelling and bloating of the abdomen (signs of inflammation of the stomach lining, also known as gastritis or gastroenteritis viral) Dry skin, itching (pruritus)
Maltese: Uġigħ addominali, dardir, rimettar, dijarea, nefħa u okkupazzjoni fl-addome (sinjali ta' infjammazzjoni tal-rita tal-istonku, magħrufa wkoll bħala gastrite jew gastroenterite virali) Ġilda xotta, ħakk (prurite)
English: Non-infectious pneumonitis (including interstitial lung disease) was described very commonly in patients taking everolimus in the advanced renal cell carcinoma (RCC) setting (see section 4.8).
Maltese: Każijiet ta' pulmonite mhux infettiva (inkluż mard tal-interstizju tal-pulmun) ġew deskritti bħala komuni ħafna f'pazjenti li qed jieħdu everolimus f'sitwazzjoni ta' karċinoma avvanzata taċ-ċellula renali (RCC) (ara sezzjoni 4.8).
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.
Maltese: Is-Cmin medja normalizzata skont id-doża mg/m kienet aktar baxxa għall-gruppi ta' età iżgħar, li jindika li ttneħħija ta' everolimus (normalizzat skont l-erja tas-superfiċje tal-ġisem) kienet ogħla fost pazjenti iżgħar.
English: A limited number of paediatric patients have been exposed to doses higher than 10 mg/m 2/day.
Maltese: Għadd limitat ta' pazjenti pedjatriċi kienu esposti għal dożi ogħla minn 10 mg/m 2/kuljum.
English: SEGA response rate 95% CI Best overall SEGA response - (%) Response Stable disease Progression Not evaluable according to independent central radiology review SEGA responses were confirmed with a repeat scan.
Maltese: L-aħjar rispons sħiħ ta' SEGA - (%) Rispons Marda stabbli Progressjoni Mhux evalwabbli Skont konsulta radjoloġika ċentrali indipendenti Ir-risponsi
English: Toxicity study with juvenile monkeys did not show any relevant toxicity.
Maltese: Studju dwar it-tossiċità f'xadini żgħażagħ ma weriex xi tossiċità relevanti.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: Response was defined as: ≥50% reduction in the sum of angiomyolipoma volume relative to baseline, plus absence of new angiomyolipoma ≥1.0 cm in longest diameter, plus no increase in renal volume >20% from nadir, plus absence of grade ≥2 angiomyolipoma-related bleeding.
Maltese: Ir-rispons kien definit bħala: ≥50% tnaqqis fit-total ta' volum tal-anġjomijolipoma relattiv għal-linja bażi, flimkien ma' nuqqas ta' anġjomijolipoma ġdida ≥1.0 ċm fl-itwal dijametru, flimkien ma' nuqqas ta' żieda fil-volum tal-kliewi >20% min-nadir, flimkien ma' assenza ta' grad ≥2 ta' fsada b'rabta mal-anġjomijolipoma.
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.
Maltese: Votubia huwa indikat għat-trattament ta' pazjenti adulti u pedjatriċi li għandhom astroċitoma subependimali b'ċellula ġganta (SEGA) assoċjata mal-kumpless sklerożi tuberoża (TSC) u jeħtieġu intervent terapewtiku imma li ma jistgħux ikunu operati.
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).
Maltese: Ir-riżultati wrew li l-objettiv primarju b'rabta mar-rispons totali tal-anġjomijolipoma ntlaħaq b'rati ta' rispons totali ta' 41.8% (95% CI: 30.8, 53.4) għall-grupp mogħti Votubia mqabbel ma' 0% (95% CI: 0.0, 9.0) għall-grupp mogħti plaċebo (p<0.
English: Each tablet contains 5 mg everolimus.
Maltese: Kull pillola fiha 5 mg everolimus.
English: Common side effects (may affect up to 1 in 10 people) Swelling, feeling of heaviness or tightness, pain, limited mobility of body parts (this could occur anywhere in the body and is a potential sign of an abnormal build-up of fluid in soft tissue due to a blockage in the lymphatic system, also known as lymphoedema) Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of serious allergic reaction, also known as hypersensitivity) Fever, cough, difficulty breathing, wheezing (signs of inflammation of the lung, also known as pneumonitis)
Maltese: Nefħa, sensazzjoni ta' toqla jew għafis, uġigħ, mobilità limitata ta' partijiet tal-ġisem (dan jista' jseħħ f'kull parti tal-ġisem u huwa sinjal potenzjali ta' akkumulazzjoni mhux normali ta' fluwidu fit-tessut l-artab minħabba sadd fis-sistema limfatika, magħrufa wkoll bħala limfoedima)
English: Exacerbation
Maltese: Aggravazzjoni
English: The potential risk for humans is unknown.
Maltese: Ir-riskju li jista' jkun hemm għall-bnedmin mhuwiex magħruf.
English: Votubia 10 mg tablets are available in packs containing 10 x 1, 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Maltese: Il-pilloli Votubia 10 mg huma disponibbli f'pakketti li fihom10 x 1, 30 x 1 jew 100 x 1 pillola f'folji mtaqqbin ta' doża waħda ta' 10 x 1 pillola kull waħda.
English: Non-responders - n (%)
Maltese: Dawk li ma rrispondewx- n (%)
English: Skin rash
Maltese: Studji oħrajn
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).
Maltese: (eż. enzima li tqanqal mediċini antiepilettiċi bħal carbamazepine, phenobarbital, u phenytoin) mat-tendija tat-trattament b'everolimus jeħtieġu żieda fid-doża inizjali sabiex jinkisbu l-inqas konċentrazzjonijiet ta' bejn 5 u 15 ng/ml (ara Tabella 1).
English: Excipient with known effect Each dispersible tablet contains 4.90 mg lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola li tinxtered fiha 4.90 mg lactose.