FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Tnaqqis sostenibbli kien evidenti fl-24 ġimgħa, 41.9% (31/74) tal-pazjenti kellhom tnaqqis ta' ≥50% u 78.4% (58/74) tal-pazjenti kellhom tnaqqis ta' ≥30% filvolum ta' SEGA.
English: In patients with SEGA, everolimus Cmin was approximately dose-proportional within the dose range from 1.35 mg/m to 14.4 mg/m
Maltese: F'pazjenti b'SEGA, is-Cmin ta' everolimus kien bejn wieħed u ieħor proporzjonali għad-doża skont ilfirxa tad-doża minn 1.35 mg/m sa 14.4 mg/m
English: The median age for the total population was 9.5 years (age range for the Votubia arm: 1.0 to 23.9; age range for the placebo arm: 0.8 to 26.6), 69.2% of the patients were aged 3 to <18 years and 17.1% were <3 years at enrolment.
Maltese: L-età medjana tal-popolazzjoni totali kienet ta' 9.5 snin (firxa ta' età għall-grupp ta' Votubia: 1.0 sa 23.9; firxa ta' età għall-grupp ta' plaċebo: 0.8 sa 26.6), 69.2% talpazjenti kellhom età ta' 3 sa <18-il sena 17.1% kellhom <3 snin meta ddaħħlu fl-istudju.
English: The seizure-free rate (the proportion of patients who became seizure-free during the maintenance period of the core phase) was 5.1% (95% CI: 1.9, 10.8) and 3.8% (95% CI: 1.3, 8.7) in the Votubia LT and HT arms, respectively, versus 0.8% (95% CI: 0.0, 4.6) of patients in the placebo arm.
Maltese: Ir-rata ta' nuqqas ta' attakki epilettiċi (il-proporzjon ta' pazjenti li ma baqgħux isofru minn attakki epilettiċi matul il-perjodu ta' manteniment tal-fażi ewlenija) kienet ta' 5.1% (95% CI: 1.9, 10.8) u 3.8% (95% CI: 1.3, 8.7) fil-gruppi mogħtija Votubia LT u HT, rispettivament, kontra 0.8% (95% CI: 0.0, 4.6) ta' pazjenti fil-grupp mogħti plaċebo.
English: Everolimus is a substrate of CYP3A4, and also a substrate and moderate inhibitor of PgP.
Maltese: Everolimus huwa substrat għal CYP3A4, u huwa wkoll substrat u impeditur moderat ta' PgP.
English: PJP/PCP may be associated with concomitant use of corticosteroids or other immunosuppressive agents.
Maltese: PJP/PCP tista' tkun assoċjata mal-użu fl-istess waqt ta' kortikosterojdi jew sustanzi immunosoppressivi oħra.
English: Single doses of up to 70 mg have been given with acceptable acute tolerability in the adult population.
Maltese: Dożi waħdiet sa 70 mg ngħataw b'tollerabbiltà akuta aċċettabbli fil-popolazzjoni adulta.
English: At weeks 12, 96 and 192, ≥ 30% reductions in volume were observed in 75.0%, 80.6%, and 85.2% of the treated patients, respectively.
Maltese: Fil-ġimgħat 12, 96 u 192, ≥ ġie rreġistrat 30% tnaqqis fil-volum ta' 75.0%, 80.
English: In patients with TSC and refractory seizures, a conditional logistic regression analysis based on the core phase of Study CRAD001M2304 to estimate the probability of seizure response versus Time Normalized(TN)-Cmin stratified by age sub-group, indicated that a 2-fold increase in TN-Cmin was associated with a 2.172-fold increase (95% CI: 1.339, 3.524) in the odds for a seizure response over the observed TN-Cmin ranges of 0.97 ng/ml to 16.40 ng/ml.
Maltese: F'pazjenti b'TSC u attakki epilettiċi refrattorji, analiżi tar-rigressjoni loġistika kundizzjonali abbażi tal-fażi ewlenija tal-Istudju CRAD001M2304 biex tiġi stmata l-probbabiltà ta' rispons tal-attakki epilettiċi kontra n-Normalizzazzjoni maż-Żmien(TN)-Cmin stratifikata skont is-sottogrupp tal-età wriet li kien hemm żieda doppja fit-TN-Cmin li kienet assoċjata ma' żieda ta' 2.172 (95% CI: 1.229, 3.524) fost l-odds fejn jidħol ir-rispons tal-attakki epilettiċi fuq il-firxiet osservati ta' TN-Cmin ta' 0.97 ng/ml sa 16.40 ng/ml.
English: Based on in vitro results, the systemic concentrations obtained after oral daily doses of 10 mg make inhibition of PgP, CYP3A4 and CYP2D6 unlikely.
Maltese: Skont riżultati in vitro, il-konċentrazzjonijiet sistemiċi miksuba wara li ngħatat doża orali ta' 10 mg kuljum ma jgħinux biex ikun hemm impediment ta' PgP, CYP3A4 u CYP2D6.
English: Everolimus is a potent inhibitor of the growth and proliferation of tumour cells, endothelial cells, fibroblasts and blood-vessel-associated smooth muscle cells and has been shown to reduce glycolysis in solid tumours in vitro and in vivo.
Maltese: Everolimus huwa impeditur b'saħħtu tat-tkabbir u l-poliferazzjoni ta' ċelluli tat-tumur, ta' ċelluli endoteljali, ta' fibroblasts u ta' ċelluli tal-muskoli lixxi assoċjati mal-vini u ntwera li jnaqqas il-glikolisi f'tumuri solidi in vitro u in vivo.
English: The blood-to-plasma ratio of everolimus, which is concentration-dependent over the range of 5 to 5,000 ng/ml, is 17% to 73%.
Maltese: Il-proporzjon ta' everolimus fid-demm u fil-plażma, li jiddependi fuq il-konċentrazzjoni fuq firxa ta' 5 sa 5,000 ng/ml, huwa minn 17% sa 73%.
English: A total of 117 patients were randomised, 78 to Votubia and 39 to placebo.
Maltese: Total ta' 117-il pazjent ingħażlu bl-addoċċ, 78 ingħataw Votubia u 39 plaċebo.
English: Primary tumour volume Mean (standard deviation)
Maltese: Volum tat-tumur primarju Medja (devjazzjoni standard)
English: 30 x 1 tablets 100 x 1 tablets
Maltese: 30 x 1 pillola 100 x 1 pillola
English: In a bioequivalence study, AUC0-inf of the 5 mg dispersible tablet when administered as suspension in water was equivalent to 5 x 1 mg intact everolimus tablets, and Cmax of the 5 mg dispersible tablet in suspension was 64% of 5 x 1 mg intact everolimus tablets.
Maltese: Fi studju dwar il-bijoekwivalenza, l-AUC 0-inf ta' pillola li tinxtered ta' 5 mg meta mogħtija bħala sospensjoni fl-ilma kienet ekwivalenti għal pilloli sħaħ b'5 x 1 mg everolimus, u s-Cmax tal-pillola li tinxtered ta' 5 mg bħala sospensjoni kien ta' 64% tal-pilloli sħaħ b'5 x 1 mg everolimus.
English: The overall safety profile in this study was consistent with that established for everolimus in the oncology and TSC settings, with the exception of a slightly increased frequency of oral candidiasis which was reported in 2.2% (n=2/92) of patients.
Maltese: Il-profil ta' sigurtà sħiħ f'dan l-istudju kien konsistenti ma' dak stabbilit għal everolimus f'ambjent ta' onkoloġija u TSC, ħlief għal żieda żgħira fil-frekwenza ta' kandidijasi orali li kienet irrappurtati fi 2.2% (n=2/92) tal-pazjenti.
English: Votubia 5 mg tablets
Maltese: Votubia 5 mg pilloli
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.
Maltese: L-impediment tar-rotta tas-sinjali minn mTORC1 tfixkel ilbdil u s-sintesi ta' proteini billi tnaqqas l-attività ta' ribosomal protein kinase S6 (S6K1) u tal-fattur li' jtawwal il-proteina li teħel 4E tal-eukaryota (4EBP-1) li jirregola l-proteini involuti fiċ-ċiklu taċ-ċelluli, fl-anġjoġenesi u fil-glikolisi. Everolimus jista' jnaqqas il-livelli tal-fattur tat-tkabbir tal-endotelju vaskolari (VEGF).
English: Stomatitis, including mouth ulcerations and oral mucositis, is the most commonly reported adverse reaction in patients treated with Votubia (see section 4.8).
Maltese: Stomatite, inkluż ulċeri fil-ħalq u mukożite orali, hi l-aktar reazzjoni avversa komuni rrappurtata f'pazjenti kkurati b'Votubia (ara sezzjoni 4.8).
English: The major target organs were male and female reproductive systems (testicular tubular degeneration, reduced sperm content in epididymides and uterine atrophy) in several species; lungs (increased alveolar macrophages) in rats and mice; pancreas (degranulation and vacuolation of exocrine cells in monkeys and minipigs, respectively, and degeneration of islet cells in monkeys), and eyes (lenticular anterior suture line opacities) in rats only.
Maltese: L-organi fil-mira ewlenija kienu s-sistemi riproduttivi tal-irġiel u tan-nisa (deġenerazzjoni tubulari tat-testikoli, tnaqqis fl-ammont tal-isperma fl-epididymis u atrofija tal-utru) f'diversi speċi; il-pulmuni (żieda fil-makrofaġi tal-alveoli) fil-ġrieden u l-firien; il-frixa (degranulazzjoni u vakulazzjoni ta' ċelluli tal-exocrine f'xadini u ħnieżer ta' razza żgħira, rispettivament, u deġenerazzjoni ta' ċelluli islets f'xadini), u l-għajnejn (opaċitajiet tal-lenti fil-linja ta' sutura anterjuri) fil-firien biss.
English: The incidence of Grade 1 stomatitis was 18.8% (n=16/85) and no cases of Grade 3 or 4 stomatitis were reported.
Maltese: L-inċidenza ta' stomatite fi Grad 1 kienet ta' 18.8% (n=16/85) u ma kien irrappurtat l-ebda każ ta' stomatite fi Grad 3 jew 4.
English: • Moderate hepatic impairment (Child-Pugh B): 50% of the recommended starting dose calculated based on BSA (rounded to the nearest strength)
Maltese: • Indeboliment moderat tal-fwied (Child-Pugh B): 50% tad-doża inizjali rrakkomandata kkalkulata abbażi tal-BSA (imnaqqsa jew miżjuda sal-eqreb doża disponibbli)
English: Two fatal cases due to infection were reported in 409 patients aged <18 years receiving everolimus.
Maltese: Kienu rapportati żewġ każijiet fatali minħabba infezzjoni f'409 pazjenti b'età ta' <18-il sena li rċevew everolimus.
English: • 10 ml oral syringe with 1 ml increments (for single use): see figure below
Maltese: • Seringa orali tal-10 ml b'żidiet ta' 1 ml (li tintuża darba biss): ara l-figura ta' hawn taħt
English: Lymphoedema
Maltese: Limfoedima
English: Baseline seizure frequency was a significant factor in the seizure response (with an odds ratio of 0.978 [95% CI: 0.959, 0.998]).
Maltese: Il-frekwenza tal-attakki epilettiċi fil-linja bażi kienet fattur ewlieni fir-rispons talattakki epilettiċi (b'odds ratio ta' 0.978 [95% CI: 0.959, 0.998]).
English: In the second study of 34 subjects with different impaired hepatic function compared to normal subjects, there was a 1.6-fold, 3.3-fold and 3.6-fold increase in exposure (i.e. AUC0-inf) for subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, respectively.
Maltese: Fit-tieni studju ta' 34 individwu b'funzjoni tal-fwied indebolita differenti imqabbla ma' individwi normali, kien hemm żidiet ta' 1.6, 3.3, u 3.6 drabi fl-esponiment (i.e.
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%.
Maltese: F'individwi b'saħħithom, it-teħid ta' doża waħda ta' 9 mg (3 x 3 mg) ta' pilloli li jinxterdu ta' Votubia f'sospensjoni, ikliet li fihom ħafna xaħam naqqsu l-AUC bi 11.7% u l-ogħla konċentrazzjoni fiddemm Cmax b'59.8%.
English: • Mild hepatic impairment (Child-Pugh A): 75% of the recommended starting dose calculated based on BSA (rounded to the nearest strength)
Maltese: • Indeboliment ħafif tal-fwied (Child-Pugh A): 75% tad-doża inizjali rrakkomandata kkalkulata abbażi tal-BSA (imnaqqsa jew miżjuda sal-eqreb doża disponibbli)
English: How to take Votubia
Maltese: Mediċini oħra u Votubia
English: Votubia 10 mg tablets everolimus
Maltese: Votubia 10 mg pilloli everolimus
English: Examples of live vaccines are: intranasal influenza, measles, mumps, rubella, oral polio, BCG (Bacillus Calmette-Guérin), yellow fever, varicella, and TY21a typhoid vaccines.
Maltese: Eżempji ta' tilqim ħaj huma: it-tilqim tal-influwenza għal ġol-imnieħer, tal-ħożba, tal-gattone, tar-rubella, tal-poljo mill-ħalq, tal-BCG (Bacillus Calmette-Guérin), tal-yellow fever, tal-ġidri r-riħ, u tat-tifojde TY21a.
English: HT target of 9-15 ng/ml
Maltese: Il-mira tal-HT ta' 9-15 ng/ml
English: Wait for 3 minutes until the dispersible tablets have completely broken apart.
Maltese: Stenna 3 minuti sakemm il-pilloli li jinxterdu ma jkunux tkissru kompletament.
English: Table 1 Votubia starting dose for patients with TSC and refractory seizures
Maltese: Tabella 1 Id-doża inizjali ta' Votubia għal pazjenti b'TSC u b'attakki epilettiċi refrattorji
English: However, a clinically relevant effect on the exposure of systemically administered CYP3A4 substrates is not expected (see section 4.4).
Maltese: Madankollu, mhuwiex mistenni effett klinikament rilevanti fuq l-espożizzjoni ta' substrati ta' CYP3A4 mogħtija b'mod sistemiku (ara sezzjoni 4.4).
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with renal failure events (including fatal outcome), proteinuria and increased serum creatinine.
Maltese: Waqt studji kliniċi u rapporti spontanji (mhux mitluba) li daħlu wara t-tqegħid tal-prodott fis-suq, everolimus kien assoċjat ma' episodji ta' insuffiċjenza tal-kliewi (inkluż b'riżultat fatali), proteinuria u żieda fil-kreatinina tas-serum.
English: AUC ↑15.3-fold (range 11.2-22.5) Cmax ↑4.1-fold (range 2.6-7.0)
Maltese: 3 drabi (firxa 11.2-22.5) Cmax ↑4.1 drabi (firxa 2.6-7.0)
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%).
Maltese: Innumru ta' pazjenti tal-onkoloġija b'reazzjoni avversa li wasslet għall-waqfien ta' everolimus kien ogħla f'pazjenti b'età ta' ≥65 sena (20% kontra 13%).
English: 30 x 1 tablets
Maltese: 30 x 1 pillola
English: Protein in the urine
Maltese: Proteini fl-awrina
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.
Maltese: Reazzjonijiet avversi oħrajn relevanti osservati waqt studji kliniċi onkoloġiċi u minn rapporti spontanji wara t-tqegħid tal-prodott fis-suq, kienu disfunzjonzjoni kardijaka, emboliżmu pulmonari, trombożi fil-vini profonda, nuqqas ta' fejqan tal-feriti u ipergliċemija.
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%.
Maltese: F'individwi b'saħħithom, ikliet li fihom ħafna xaħam naqqsu l-esponiment sistemiku għal pilloli Votubia 10 mg (kif imkejjel mill-AUC) bi 22% u l-ogħla konċentrazzjonijiet fid-demm Cmax b'54%.
English: Excipient with known effect Each tablet contains 74 mg lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 74 mg lactose.
English: • EXIST-2 (CRAD001M2302): This was a randomised, double-blind, controlled, phase III trial of everolimus (n=79) versus placebo (n=39) in patients with either TSC plus renal angiomyolipoma (n=113) or sporadic lymphangioleiomyomatosis (LAM) plus renal angiomyolipoma (n=5).
Maltese: III ta' everolimus (n=79) kontra plaċebo (n=39) f'pazjenti jew b'TSC flimkien ma' anġjomijolipoma renali (n=113) jew limfanġjolejomijomatożi sporadika (LAM) flimkien ma' anġjomijolipoma renali (n=5).
English: The median baseline seizure frequency across the treatment arms was 35, 38, and 42 seizures per 28 days for the Votubia LT, Votubia HT, and placebo groups, respectively.
Maltese: Il-frekwenza medja tal- attakki epilettiċi fil-linja bażi fost il-gruppi mogħtija t-trattament kienet ta' 35, 38 u 42 attakk epilettiku kull 28 jum għall-gruppi mogħtija Votubia LT, Votubia HT, u plaċebo, rispettivament.
English: Excipient with known effect Each dispersible tablet contains 2.94 mg lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola li tinxtered fiha 2.94 mg lactose.
English: The effect is likely to be due to inhibition of intestinal CYP3A4 by everolimus.
Maltese: Huwa probabbli li l-effett iseħħ minħabba l-impediment ta' CYP3A4 flimsaren minn everolimus.
English: Post-hoc sub-group analysis of EXIST-2 (study CRAD001M2302) carried out at time of primary analysis demonstrated that angiomyolipoma response rate is reduced below the threshold of 5 ng/ml (Table 5).
Maltese: Analiżi post-hoc fost is-sottogrupp ta' EXIST-2 (studju CRAD001M2302) li saret fi żmien l-analiżi primarja wriet li r-rata ta' rispons ta' anġjomijolipoma tonqos għal taħt il-massimu ta' 5 ng/ml (Tabella 5).
English: However products containing alcohol, hydrogen peroxide, iodine and thyme derivatives should be avoided as they may exacerbate the condition.
Maltese: Madanakollu prodotti li fihom l-alkoħol, hydrogen peroxide, jodju u derivattivi mis-sagħtar għandhom jiġu evitati minħabba li jistgħu jħarrxu l-kundizzjoni.
English: In a male fertility study in rats, testicular morphology was affected at 0.5 mg/kg and above, and sperm motility, sperm head count, and plasma testosterone levels were diminished at 5 mg/kg, which is within the range of therapeutic exposure and which caused a reduction in male fertility.
Maltese: Fi studju ta' fertilità tar-raġel fil-firien, il-morfoloġija tat-testikoli kienet affettwata f'doża ta' 0.5 mg/kg u aktar, u l-motilità tal-isperma, l-għadd ta' sperma, u l-livelli ta' testosteron fil-plażma kienu mnaqqsa f'doża ta' 5 mg/kg, li hija fil-firxa ta' esponiment terapewtiku u li kkawżat tnaqqis filfertilità tar-raġel.
English: Nose bleeds (epistaxis)
Maltese: Fsada mill-imnieħer (epistassi)
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.
Maltese: L-istudju evalwa b'mod indipendenti żewġ endpoints primarji differenti: 1) ir-rata ta' rispons definita bħala mill-inqas 50% tnaqqis mil-linja bażi fil-frekwenza tal-attakki epilettiċi tat-tip parzjali matul ilperjodu ta' manutenzjoni waqt il-fażi ewlenija; u 2) tnaqqis perċentwali mil-linja bażi fil-frekwenza tal-attakki epilettiċi tat-tip parzjali matul il-perjodu ta' manutenzjoni waqt il-fażi ewlenija.
English: Post-transplant renal impairment (creatinine clearance range 11-107 ml/min) did not affect the pharmacokinetics of everolimus in transplant patients.
Maltese: Indeboliment tal-kilwa wara trapjant (firxa ta' tneħħija tal-kreatinina minn 11-107 ml/min) m'affettwatx il-farmakokinetika ta' everolimus f'pazjenti bi trapjanti.
English: Stomatitis is the most commonly reported adverse reaction in patients treated with Votubia (see sections 4.4 and 4.8).
Maltese: Stomatite hi l-aktar reazzjoni avversa komuni rrappurtata f'pazjenti kkurati b'Votubia (ara sezzjonijiet 4.4 u 4.8).
English: If not administered within 30 minutes of preparation when using an oral syringe or 60 minutes when using a small glass, the suspension must be discarded and a new suspension must be prepared.
Maltese: Jekk is-sospensjoni ma tintużax fi żmien 60 minuta, armiha u ipprepara suspensjoni ġdida.
English: Titration
Maltese: Titrazzjoni
English: A population pharmacokinetic analysis including 111 patients with SEGA who ranged from 1.0 to 27.4 years (including 18 patients 1 to less than 3 years of age with BSA 0.42 m to 0.74 m 2) showed that BSA-normalised clearance is in general higher in younger patients.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tinkludi 111-il pazjent b'SEGA li għandhom bejn 1.0 u 27.4 snin (inkluż 18-il pazjent li għandhom bejn sena u anqas minn 3 snin b'BSA ta' bejn 0.
English: Discontinue Votubia.
Maltese: Waqqaf Votubia.
English: 100 x 1 tablets
Maltese: 100 x 1 pillola
English: Dosing is individualised based on Body Surface Area (BSA) using the Dubois formula, where weight (W) is in kilograms and height (H) is in centimetres:
Maltese: Id-doża mogħtija tkun individwalizzata skont is-Superfiċje tal-Ġisem (BSA) billi tintuża l-formula Dubois, fejn il-piż (W) hu f'kilogrammi u l-għoli (H) hu f'ċentimetri:
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.
Maltese: Bl-istess mod, fl-istess punti taż-żmien, ġie rreġistrat tnaqqis ta'≥50% fil -volum f'44.2%, 63.3% u 68.9% tal-pazjenti ttrattati, rispettivament.
English: Individualised dose titration can be based on simple proportion:
Maltese: It-titrazzjoni tad-doża individwalizzata tista' tissejjes fuq proporzjon sempliċi:
English: If Votubia is taken with orally administered CYP3A4 substrates with a narrow therapeutic index (e.g. pimozide, terfenadine, astemizole, cisapride, quinidine, ergot alkaloid derivatives or carbamazepine), the patient should be monitored for undesirable effects described in the product information of the orally administered CYP3A4 substrate (see section 4.5).
Maltese: Jekk Votubia jittieħed flimkien ma' substrati ta' CYP3A4 li jittieħdu mill-ħalq b'indiċi terapewtiku dejjaq (eż. pimozide, terfenadine, astemizole, cisapride, quinidine, derivati ta' ergot alkaloids jew carbamazepine), il-pazjent għandu jiġi mmonitorjat għal effetti mhux mixtieqa deskritti flinformazzjoni dwar il-prodott tas-substrat ta' CYP3A4 mogħti mill-ħalq (ara sezzjoni 4.5).
English: Votubia 5 mg tablets everolimus
Maltese: Votubia 5 mg pilloli everolimus
English: In patients with TSC and refractory seizures receiving Votubia dispersible tablets, a trend was observed toward lower Cmin normalised to dose (as mg/m2) in younger patients.
Maltese: F'pazjenti b'TSC u b'attakki epilettiċi refrattorji mogħtija Votubia pilloli li jinxterdu, kienet osservata tendenza għal Cmin aktar baxxa normalizzata skont id-doża (bħala mg/m2) fost pazjenti iżgħar.
English: Co-administration with inhibitors and inducers of CYP3A4 and/or the multidrug efflux pump P-glycoprotein (PgP) should be avoided.
Maltese: L-għoti flimkien ma' impedituri u indutturi ta' CYP3A4 u/jew il-pompa ta' effluss ta' ħafna mediċini tal-glikoproteina P (PgP) għandhom jiġu evitati.
English: Temporary dose interruption until recovery to Grade 2 (≥1.25x10
Maltese: Interrompi d-doża temporanjament sakemm ikun hemm titjib f' Grad 2 (≥1.25x10
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.
Maltese: F'pazjenti b'SEGA, il-medja ġeometrika tal-valuri tas-Cmax normalizzati għal doża ta' mg/m f'pazjenti li għandhom <10 snin u 10-18-il sena kienu anqas b'54% u b'40%, rispettivament, minn dawk osservati fost l-adulti (>18-il sena), li jissuġġerixxi li t-tneħħija ta' everolimus kien ogħla f'pazjenti iżgħar.
English: Mean CL/F of everolimus after 10 mg daily dose in patients with advanced solid tumours was 24.5 l/h.
Maltese: Il-medja CL/F ta' everolimus wara doża ta' 10 mg kuljum f'pazjenti b'tumuri solidi avanzati kienet ta' 24.5 l/siegħa.
English: Based on a sensitivity analysis considering patients who prematurely discontinued everolimus as nonresponders, response rates of 38.4% (95% CI: 33.4, 43.7) and 44.4% (95% CI: 38.2, 50.7) were observed after 1 and 2 years of exposure to everolimus, respectively.
Maltese: Abbażi ta' analiżi tas-sensittività li tikkunsidra l-pazjenti li ma komplewx everolimus qabel iż-żmien bħala li ma rrispondewx għall-kura, kienu osservati rati ta' rispons ta' 38.4% (95% CI: 33.4, 43.7) u 44.4% (95% CI: 38.2, 50.7) wara sena u sentejn ta' esponiment għal everolimus, rispettivament.
English: Other possible side effects of Votubia include:
Maltese: Effetti sekondarji possibli oħra ta' Votubia jinkludu:
English: Reduction from baseline in seizure frequency (%)
Maltese: Tnaqqis mil-linja bażi fil-frekwenza tal-attakki epilettiċi (%)
English: Angiomyolipoma response rate 95% CI
Maltese: Rata ta' rispons SEGA 95% CI
English: Metabolism and nutrition disorders Very common Decreased appetite, hypercholesterolaemia Common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna Tnaqqis fl-aptit, iperkolesterolemija Komuni
English: If stomatitis recurs at Grade 2, interrupt dose until recovery to Grade 1.
Maltese: Jekk jerġa' jkun hemm stomatite fi Grad 2, waqqaf id-doża sakemm jitjieb f' Grad 1.
English: 95% CI p-value (versus placebo)
Maltese: Valur-p (kontra l-plaċebo)
English: Grade 4 (<0.5x10
Maltese: Grad 4 (<0.
English: Votubia dispersible tablets contain an active substance called everolimus.
Maltese: Votubia pilloli li jinxterdu fihom sustanza attiva msejħa everolimus.