FrancophonIA/ELRC3.0 huggingface dataset:
English: Percentage reduction from baseline, n (%)
Maltese: Tnaqqis perċentwali mil-linja bażi, n (%)
English: The most frequent grade 3-4 adverse reactions (incidence ≥1%) were pneumonia, stomatitis, amenorrhoea, neutropenia, pyrexia, menstruation irregular, hypophosphataemia, diarrhoea, and cellulitis.
Maltese: L-aktar reazzjonijiet avversi frekwenti fi grad 3-4 (inċidenza ta' ≥1%) kienu pulmonite, stomatite, amenorrea, newtropenija, deni, mestrwazzjoni irregolari, ipofosfatimja, dijarea u ċellulite.
English: In clinical studies, everolimus has been associated with haemorrhage events.
Maltese: Fi studji kliniċi, everolimus kien assoċjat ma' episodji ta' emorraġija.
English: Date of first authorisation: 02 September 2011 Date of latest renewal: 28 July 2015
Maltese: Data tal-aħħar tiġdid: 28 Lulju 2015
English: The proportion of patients achieving at least 50% reductions in SEGA volume was 45.9% (45/98) and 62.1% (41/66) at weeks 96 and 192 after start of everolimus treatment.
Maltese: Il-proporzjon ta' pazjenti li kisbu tnaqqis ta' mill-inqas 50% fil-volum ta' SEGA kien ta' 45.9% (45/98) u 62.1% (41/66) fil-ġimgħat 96 u 192 wara l-bidu tat-trattament b'everolimus.
English: Metabolic events (e.g. hyperglycaemia, dyslipidaemia)
Maltese: Episodji metaboliċi (eż. ipergliċemija, dislipidemija)
English: Epistaxis, pneumonitis Gastrointestinal disorders Very common Stomatitis b, diarrhoea, vomiting
Maltese: Epistassi, pulmonite Disturbi gastro-intestinali Komuni ħafna Stomatite b, dijarrea, rimettar
English: Table 5 EXIST-3 - Seizure frequency response rate (primary endpoint)
Maltese: EXIST-3 - Ir-rata ta' rispons tal-frekwenza tal-attakki epilettiċi (endpoint primarju)
English: Dyslipidaemia (including hypercholesterolaemia and hypertriglyceridaemia) has been reported in patients taking Votubia.
Maltese: Dislipidimja (inkluż iperkolesterolimja u ipertrigliċeridimja) kienet irrappurtata f'pazjenti li jieħdu Votubia.
English: Month 36 n=23
Maltese: 36 Xahar n=23
English: Anaemia, neutropenia, leucopenia, thrombocytopenia, lymphopenia Immune system disorders
Maltese: Anemija, newtropenija, lewkopenija, tromboċitopenija, limfopenija Disturbi fis-sistema immuni
English: Disturbed taste (dysgeusia)
Maltese: Sens ta' tegħim disturbat (diżgweżja)
English: The baseline data indicated mild to moderate mental retardation in patients 6-18 years of age (scores of 60-70 on the Adaptive Behavior Composite and Communication, Daily Living Skills, and Socialization Domain Scores).
Maltese: Iddejta fil-linja bażi wriet diffikultajiet mentali minn ħfief sa moderati f'pazjenti ta' bejn 6 u 18-il sena (punteġġi ta' 60-70 skont l-Adaptive Behavior Composite and Communication, Daily Living Skills, u Socialization Domain Scores).
English: mTORC1 activation leads to a downstream kinase signalling cascade, including activation of the S6 kinases.
Maltese: L-attivazzjoni ta' mTORC1 twassal għal tnaqqis tas-sinjali mill-kaskata tal-kinasi, inkluż lattivazzjoni tal-kinasi S6.
English: In patients with advanced solid tumours, Vd was 191 l for the apparent central compartment and 517 l for the apparent peripheral compartment.
Maltese: F'pazjenti b'tumuri solidi avanzati l-Vd kien ta' 191 l għal kompartament ċentrali li jidher u 517 l għal kompartament periferali li jidher.
English: Excipient with known effect Each tablet contains 297 mg lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 297 mg lactose.
English: If toxicity becomes intolerable, temporary dose interruption until recovery to Grade 1.
Maltese: Jekk it-tossiċità ssir intollerabbli, interrompi temporanjament id-doża sakemm jirkupra għal  Grad 1.
English: Non-infectious pneumonitis
Maltese: Pulmonite mhux infettiva
English: Responders - n (%) Response rate 95% CI
Maltese: Dawk li rrispondew- n (%) Rata ta'rispons 95% CI
English: Febrile neutropenia
Maltese: Newtropenija febrili
English: Similarly, the proportion of patients achieving at least 30% reductions in SEGA volume was 71.4% (70/98) and 77.3% (51/66) at weeks 96 and 192 after start of everolimus treatment.
Maltese: Bl-istess mod, il-proporzjon ta' pazjenti li kisbu tnaqqis ta' mill-inqas 30% fil-volum ta' SEGA kien ta' 71.4% (70/98) u 77.3% (51/66) fil-ġimgħat 96 u 192 wara l-bidu tat-trattament b'everolimus.
English: c p-values computed from the Cochran-Mantel-Haenszel test stratified by age subgroup d
Maltese: Il-valuri-p maħdumin skont it-test Cochran-Mantel-Haenszel stratifikat skont is-sottogruppi tal-età d
English: A total of 366 patients were randomised in a 1:1.09:1 ratio to Votubia (n=117) low trough (LT) range (3 to 7 ng/ml), Votubia (n=130) high trough (HT) range (9 to 15 ng/ml) or placebo (n=119).
Maltese: Total ta' 366 pazjent kienu randomizzati skont proporzjon ta' 1:1.09:1 għall-inqas medda (LT) ta' Votubia (n=117) (3 sa 7 ng/ml), għall-ogħla l-inqas medda (HT) ta' Votubia (n=130) (9 sa 15 ng/ml) jew plaċebo (n=119).
English: Two primary regulators of mTORC1 signalling are the oncogene suppressors tuberin-sclerosis complexes 1 & 2 (TSC1, TSC2).
Maltese: Żewġ regolaturi ewlenin tas-sinjali minn mTORC1 huma l-kumplessi sklerożi-tuberin 1 u 2 li jrażżnu l-onkoġenu (TSC1, TSC2).
English: • Moderate hepatic impairment (Child-Pugh B): The recommended dose is 5 mg daily.
Maltese: • Indeboliment moderat tal-fwied (Child-Pugh B): id-doża rrakkomandata hi ta' 5 mg kuljum.
English: The median duration of the double-blind period was 18 weeks.
Maltese: Id-dewmien medju tal-perjodu double-blind kien ta' 18-il ġimgħa.
English: • Mild hepatic impairment (Child-Pugh A): The recommended dose is 7.5 mg daily.
Maltese: • Indeboliment ħafif tal-fwied (Child-Pugh A): id-doża rrakkomandata hi ta' 7.5 mg kuljum.
English: Potent CYP3A4/PgP inhibitors Ketoconazole
Maltese: Impedituri qawwija ta' CYP3A4/PgP Ketoconazole
English: Name and address of the manufacturer responsible for batch release Novartis Pharma GmbH
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Novartis Pharma GmbH
English: • 1 small glass (maximum size 100 ml)
Maltese: • Tazza waħda żgħira (qies massimu ta' 100 ml)
English: Light fat meals reduced AUC by 29.5% and Cmax by 50.2%.
Maltese: Ikliet bi ftit xaħam naqqsu l-AUC b'29.5% u Cmax b'50.
English: The incidence of skeletal variations and malformations (e.g. sternal cleft) was increased at 0.3 and 0.9 mg/kg.
Maltese: L-inċidenza ta' varjazzjonijiet skeletrali u malformazzjonijiet (eż. sternu mixquq) żdiedet f'dożi ta' 0.3 u 0.9 mg/kg.
English: 12 to <18 years n=26
Maltese: 12 sa <18-il sena n=26
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of pneumocystis jirovecii (carinii) pneumonia (PJP, PCP), some with fatal outcome (see section 4.4).
Maltese: Fi studji kliniċi u rapporti spontanji ta' wara t-tqegħid fis-suq, everolimus kien assoċjat ma' każijiet ta' pulmonite kkawżata minn pneumocystis jirovecii (carinii) (PJP, PCP), uħud b'riżultat fatali (ara sezzjoni 4.4).
English: Hypertriglyceridaemia, hyperlipidaemia, hypophosphataemia, hyperglycaemia Psychiatric disorders
Maltese: Ipertrigliċeridemija, iperlipidemija, ipofosfatemija, ipergliċemija Disturbi psikjatriċi
English: Excipient with known effect Each dispersible tablet contains 1.96 mg lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola li tinxtered fiha 1.96 mg lactose.
English: There was evidence of reversibility.
Maltese: Kien hemm evidenza ta' riversibilità.
English: Figure 1 EXIST-3 - Distribution of reduction from baseline in seizure frequency
Maltese: Figura 1 EXIST-3 - Distribuzzjoni tat-tnaqqis mil-linja bażi fil-frekwenza tal-attakki epilettiċi
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.
Maltese: F'analiżi farmakokinetika ta' popolazzjoni ta' 170 pazjent b'tumuri solidi avanzati, l-ebda influwenza sinifikanti ta' tneħħija tal-kreatinina (25-178 ml/min) ma kienet osservata fuq is-CL/F ta' everolimus.
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).
Maltese: Fil-linja bażi 19.4% tal-pazjenti kellhom attakki epilettiċi fokali b'għarfien miżmum (sensorjali kkonfermati minn qabel permezz ta' EEG jew motorika), 45.1% kellhom attakki epilettiċi fokali b'għarfien indebbolit (predominament mhux motorika), 69.1% kellhom attakki epilettiċi motoriċi fokali (jiġifieri attakki epiletteiċi motoriċi fokali b'indeboliment fl-għarfien u/jew attakki epilettiċi ġeneralizzati sekondarji), u 1.6% kellhom bidu ta' attakki epilettiċi (ikkonfermata minn qabel b'ECG).
English: The other ingredients are butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and lactose anhydrous.
Maltese: Is-sustanzi l-oħra huma butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A u lactose anhydrous.
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.
Maltese: Total ta' 49 minn 137 pazjent (36%) b'età ta' <6 snin kellhom infezzjonijiet ta' Grad 3/4, meta mqabbla ma' 53 minn 272 pazjent (19%) b'età bejn 6 sa <18-il sena u 27 minn 203 pazjenti (13%) b'età ta' ≥18-il sena.
English: AUC ↑4.4-fold (range 2.0-12.6) Cmax ↑2.0-fold (range 0.9-3.5)
Maltese: AUC ↑4.4 drabi (firxa 2.0-12.6) Cmax ↑2.0 drabi (firxa 0.9-3.5)
English: Interaction - Change in Everolimus AUC/Cmax Geometric mean ratio (observed range)
Maltese: Interazzjoni - Bidla flAUC/Cmax ta' Everolimus Proporzjon medju ġeometriku (firxa osservata)
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.
Maltese: Sar studju prospettiv u open-label, fuq grupp ta' pazjenti f'fażi II (Studju CRAD001C2485) sabiex jevalwa s-sigurtà u l-effikaċja ta' Votubia f'pazjenti b'SEGA.
English: In total, 28 patients received treatment with Votubia; median age was 11 years (range 3 to 34), 61% male, 86% Caucasian.
Maltese: B'kollox, 28 pazjent ingħataw trattament b'Votubia; l-età medja kienet ta' 11-il sena (firxa ta' 3-34), 61% rġiel, 86% Kawkażjatiċi.
English: In the oncology safety pooling, 37% of the patients treated with everolimus were ≥65 years of age.
Maltese: Fil-ġbir tas-sigurtà tal-onkoloġija, 37% tal-pazjenti kkurati b'everolimus kellhom età ta' ≥65 sena.
English: In clinical studies, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome.
Maltese: Fl-istudji kliniċi, everolimus ġie assoċjat ma' każi serji ta' attivazzjoni mill-ġdid tal-epatite B, inkluż b'riżultat fatali.
English: In the total population, 57.3% of patients were male and 93.2% were Caucasian.
Maltese: Fil-popolazzjoni totali, 57.3% tal-pazjenti kienu rġiel u 93.2% kienu Kawkasi.
English: Of the enrolled patients, 83.1% had angiomyolipomas ≥4 cm (28.8% ≥8 cm), 78.0% had bilateral angiomyolipomas, and 39.0% had undergone prior renal embolisation/nephrectomy; 96.6% had skin lesions at baseline and 44.1% had target SEGAs (at least one SEGA ≥1 cm in longest diameter).
Maltese: Mill-pazjenti msieħba, 83.1% kellhom anġjomijolipoma ≥4 ċm (28.8% ≥8 ċm), 78.0% kellhom lanġjomijolipoma bilaterali, u 39.0% kellhom emboliżazzjoni renali/nefrekotomija mgħoddija; 96.6% kellhom feriti fil-ġilda fil-linja bażi u 44.1% kellhom SEGAs maħsuba (mill-inqas ≥1 ċm fl-itwal dijametru).
English: Excipient with known effect Each dispersible tablet contains 0.98 mg lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola li tinxtered fiha 0.98 mg lactose.
English: Table 3 Effects of other active substances on everolimus
Maltese: Tabella 3 Effetti ta' sustanzi attivi oħrajn fuq everolimus
English: Pharmacokinetic/pharmacodynamic relationship(s)
Maltese: Relazzjoni(jiet) farmakokinetiċi/farmakodinamiċi
English: Everolimus is a substrate of CYP3A4 and PgP.
Maltese: Everolimus huwa substrat ta' CYP3A4
English: Proportion of patients (%)
Maltese: Proporzjon ta' pazjenti (%)
English: Votubia 10 mg tablets
Maltese: Votubia 10 mg pilloli
English: Insomnia, aggression, irritability Nervous system disorders Very common Headache Uncommon Dysgeusia Vascular disorders Very common Hypertension Common
Maltese: Nuqqas ta' rqad, aggressjoni, irritabbiltà Disturbi fis-sistema nervuża Komuni ħafna Uġigħ ta' ras Mhux komuni Disgweżja Disturbi vaskulari
English: In the pivotal phase III study in patients with TSC and refractory seizures, 299 of the 366 patients studied were below the age of 18 years.
Maltese: III f'pazjenti b'TSC u b'attakki epilettiċi refrattorji, 299 minn 366 pazjent studjati kellhom anqas minn 18-il sena.
English: The angiomyolipoma best overall response rate had increased to 58.0% (95% CI: 48.3, 67.3), with a rate of stable disease of 30.4% (Table 4).
Maltese: L-aħjar rata ta' rispons totali għall-anġjomijolipoma kien żdied għal 58.0% (95% CI: 48.3, 67.3), b'rata ta' mard stabbli ta' 30.4 % (Tabella 4).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Menstruation disorders such as absence of periods (amenorrhoea) or irregular periods Sore throat (pharyngitis)
Maltese: Disturbi fil-mestrwazzjoni bħal nuqqas ta' periods (amenorrea) jew periods irregolari Uġigħ fil-griżmejn (farinġite)
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.
Maltese: Kien osservat trattament konsistenti fost is-sottogruppi kollha analizzati (i.e. l-użu ta' antiepilettiċi li jinduċu l-enzimi kontra n-nuqqas ta' użu ta' antiepilettiċi li jinduċu l-enzimi, is-sess u l-età) fl-analiżi primarja.
English: Baseline seizure frequency and TN-Cmin were both significant factors (α=0.05) in predicting the absolute seizure frequency in the linear regression model.
Maltese: Il-frekwenza tal-attakki epilettiċi fil-linja bażi u t-TN-Cmin kienu t-tnejn fatturi sinjifikanti (α=0.05) fit-tbassir tal-frekwenza tal-attakki epilettiċi assoluti skont il-mudell ta' rigressjoni lineari.
English: Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets everolimus
Maltese: Votubia 2.5 mg pilloli Votubia 5 mg pilloli Votubia 10 mg pilloli everolimus
English: Limited data in patients <3 years of age (n=13) indicate that BSA-normalised clearance is about two-fold higher in patients with low BSA (BSA of 0.556 m2) than in adults.
Maltese: Dejta limitata minn pazjenti li għandhom <3 snin (n=13) turi li t-tneħħija normalizzata tal-BSA hi madwar darbtejn iktar f'pazjenti b'BSA baxx (BSA ta' 0.556 m2) milli fladulti.
English: Table 2 Effects of other active substances on everolimus
Maltese: Tabella 2 Effetti ta' sustanzi attivi oħrajn fuq everolimus
English: No data are available (see sections 5.1 and
Maltese: M'hemm l-ebda dejta disponibbli (ara sezzjonijiet 5.1 u
English: Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)
Maltese: Astroċitoma subependimali b'ċellula ġganta (SEGA) assoċjata mal-kumpless sklerożi tuberoża (TSC)
English: LT target of 3-7 ng/ml
Maltese: Il-mira tal-LT ta' 3-7 ng/ml
English: Median age was 31 years (range: 18 to 61 years; 46.6% were <30 years at enrolment), 33.9% were male, and 89.0% were Caucasian.
Maltese: L-età medjana kienet ta' 31 sena (medda: 18 sa 61 sena; 46.6% kienu <30 sena mas-sħubija), 33.9% kienu rġiel, u 89.0% kineu Kawkażjatiċi.
English: • <18 years of age with SEGA or refractory seizures and concomitant hepatic impairment (Child-Pugh A, B and C) (see sections 4.2 and 5.2).
Maltese: • ta' <18-il sena b'SEGA u fl-istess ħin indeboliment tal-fwied (Child-Pugh A, B u Ċ) (ara sezzjonijiet 4.2 u 5.2).
English: Grade 3 (<1, ≥0.5x10
Maltese: (<1, ≥0.5x10
English: The median duration of exposure was 67.8 months (range 4.7 to
Maltese: Id-dewmien medjan tal-esponiment kien ta' 67.8 xhur (firxa 4.7 sa 83.2).
English: AUC ↑2.7-fold (range 1.5-4.7) Cmax ↑1.8-fold (range 1.3-2.6)
Maltese: AUC ↑2.7 drabi (firxa 1.5-4.7) Cmax ↑1.8 drabi (firxa 1.3-2.6)
English: According to independent central radiology review Angiomyolipoma responses were confirmed with a repeat scan.
Maltese: Skont konsulta radjoloġika ċentrali indipendenti Ir-risponsi tal-anġjomijolipoma kienu kkonferamti permezz ta' scan ripetuti.
English: The most frequent adverse reactions (incidence ≥1/10) from the pooled safety data are (in decreasing order): stomatitis, pyrexia, nasopharyngitis, diarrhoea, upper respiratory tract infection, vomiting, cough, rash, headache, amenorrhoea, acne, pneumonia, urinary tract infection, sinusitis, menstruation irregular, pharyngitis, decreased appetite, fatigue, hypercholesterolaemia, and hypertension.
Maltese: L-aktar reazzjonijiet avversi frekwenti (inċidenza ≥1/10) minn dejta dwar is-sigurtà miġbura huma (blaktar frekwenti mniżżla l-ewwel): stomatite, deni, nażofarinġite, dijarrea, infezzjoni fl-apparat respiratorju ta' fuq, rimettar, sogħla, raxx, uġigħ ta' ras, amenorrea, akne, pulmonite, infezzjoni flapparat tal-awrina, sinożite, mestrwazzjoni irregolari, farinġite, nuqqas ta' aptit, għeja, iperkolesterolimja u pressjoni għolja.
English: Median time to angiomyolipoma progression was 11.4 months in the placebo arm and was not reached in the everolimus arm (HR 0.08; 95% CI: 0.02, 0.37; p<0.0001).
Maltese: Iż-żmien medju tal-progressjoni tal-anġjomijolipoma kien ta' 11.4 xhur fil-grupp mogħti l-plaċebo u ma ntlaħaqx fil-grupp mogħti everolimus (HR 0.08; 95% CI: 0.02, 0.37; p<0.0001).
English: Higher proportions of responders were evident for all response categories in the Votubia LT and HT arms relative to placebo (Figure 1).
Maltese: Proporzjonijiet ogħla ta' dawk li rrispondew kienu evidenti fil-kategoriji kollha ta' risposti fost ilgruppi mogħtija Votubia LT u HT relattiv għall-plaċebo (Figura 1).
English: In a population pharmacokinetic evaluation in cancer patients, no significant influence of age (27-85 years) on oral clearance of everolimus was detected.
Maltese: Fi stima farmakokinetika ta' popolazzjoni f'pazjenti morda bil-kanċer, ma kienet osservata l-ebda influwenza sinifikanti tal-età (27-85 sena) fuq it-tneħħija orali ta' everolimus.
English: Opportunistic infections such as pneumocystis jirovecii (carinii) pneumonia (PJP, PCP) should be ruled out in the differential diagnosis of non-infectious pneumonitis (see section “Infections” below).
Maltese: Infezzjonijiet opportunistiċi bħal pulmonite kkawżata minn pneumocystis jirovecii (carinii) (PJP, PCP - pneumocystis jirovecii (carinii) pneumonia) għandhom jiġu esklużi fiddijanjosi differenzjali ta' pulmonite mhux infettiva (ara s-sezzjoni “Infezzjonijiet” hawn taħt).
English: Frequency based upon number of women from 10 to 55 years of age while on treatment in the pooled data
Maltese: Frekwenza bbażata fuq numru ta' nisa b'età minn 10 sa 55 sena li kienu qed jieħdu ttrattament fid-dejta miġbura
English: 10 x 1 tablets 30 x 1 tablets 100 x 1 tablets
Maltese: 10 x 1 pillola 30 x 1 pillola 100 x 1 pillola
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.
Maltese: Infezzjonijiet lokalizzati u sistemiċi, inkluż pulmonite, u infezzjonijiet oħrajn bilbatteriji, infezzjonijiet invażivi bil-fungu bħal asperġillożi, kandidjasi jew pulmonite kkawżata minn pneumocystis jirovecii (carinii) (PJP, PCP) u infezzjonijiet bil-viruses, inklużi attivazzjoni mill-ġdid tal-virus tal-epatite B, kienu deskritti f'pazjenti li qed jieħdu everolimus.
English: AUC ↑3.5-fold (range 2.2-6.3) Cmax ↑2.3-fold (range1.3-3.8)
Maltese: AUC ↑3.5 drabi (firxa 2.2-6.3) Cmax ↑2.3 drabi (firxa 1.3-3.8)
English: SEGA associated with TSC
Maltese: SEGA assoċjata ma' TSC
English: Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets
Maltese: IL-PRODOTT MEDIĊINALI Votubia 2.5 mg pilloli Votubia 5 mg pilloli Votubia 10 mg pilloli
English: ANNEX II
Maltese: Tabella 4
English: Stable disease Progression
Maltese: Marda stabbli Progressjoni
English: Consistent results were found for the supportive analysis of the median percentage reduction from baseline in seizure frequency (other primary endpoint): 29.3% (95% CI: 18.8, 41.9) in the Votubia LT arm, 39.6% (95% CI: 35.0, 48.7) in the Votubia HT arm and 14.9% (95% CI: 0.1, 21.7) in the placebo arm.
Maltese: Instabu riżultati konsistenti għall-analiżi ta' appoġġ tat-tnaqqis fil-perċentwal medjan mil-linja bażi fil-frekwenza ta' attakki epilettiċi (endpoint primarju ieħor): 29.3% (95% CI: 18.8, 41.9) fil-grupp mogħti Votubia LT, 39.6% (95% CI: 35.0, 48.7) fil-grupp mogħti Votubia HT u 14.9% (95% CI: 0.1, 21.7) fil-grupp mogħti plaċebo.
English: Votubia 2.5 mg tablets
Maltese: Votubia 2.5 mg pilloli
English: 10 x 1 tablets
Maltese: 10 x 1 pilloli
English: Consider interruption of therapy until symptoms improve to Grade 1.
Maltese: Ikkunsidra t-twaqqif tat-terapija sa ma jitjiebu s-sintomi għal  Grad 1.
English: In a relative bioavailability study, AUC0-inf of 5 x 1 mg everolimus tablets when administered as suspension in water was equivalent to 5 x 1 mg everolimus tablets administered as intact tablets, and Cmax of 5 x 1 mg everolimus tablets in suspension was 72% of 5 x 1 mg intact everolimus tablets.
Maltese: Fi studju dwar il-bijodisponibbiltà relattiva, l-AUC 0--inf ta' pilloli b'5 x 1 mg everolimus meta mogħtija bħala sospensjoni fl-ilma kienet ekwivalenti għal pilloli b'5 x 1 mg everolimus mogħtija bħala pilloli sħaħ, u s-Cmax ta' pilloli everolimus 5 x 1 mg f'sospensjoni kien ta' 72% tal-pilloli sħaħ b'5 x 1 mg everolimus.
English: The incidence of Grade ≥2 stomatitis at 8 weeks was 2.4% (n=2/85 evaluable patients) which was lower than historically reported.
Maltese: L-inċidenza ta' stomatite fi Grad ≥2 fit-8 ġimgħat kienet ta' 2.4% (n=2/85 pazjenti evalwabbli) li kienet inqas minn dik irrappurtata storikament.
English: Excipient with known effect Each tablet contains 149 mg lactose.
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 149 mg lactose.
English: Votubia 2.5 mg tablets everolimus
Maltese: Votubia 2.5 mg pilloli everolimus
English: Studies in animals have shown reproductive toxicity effects including embryotoxicity and foetotoxicity (see section 5.3).
Maltese: Studji fuq l-annimali wrew effetti tossiċi fuq is-sistema riproduttiva inkluż tossiċità tal-embrijun u tossiċità tal-fetu (ara sezzjoni 5.3).
English: Everolimus has immunosuppressive properties and may predispose patients to bacterial, fungal, viral or protozoal infections, including infections with opportunistic pathogens (see section 4.8).
Maltese: Everolimus għandu effetti immunosoppressivi u jista' jippredisponi l-pazjenti għal infezzjonijiet bilbatterji, bil-fungu, bil-viruses jew bil-protozoan, inklużi infezzjonijiet b'patoġeni opportunistiċi (ara sezzjoni 4.8).
English: Mean (standard deviation) Median
Maltese: Medja (devjazzjoni standard) Medjan
English: Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported in patients treated with Votubia (see section 4.8).
Maltese: Emoglobina, limfoċiti, newtrofili u plejtlits imnaqqsa ġew irrappurtati f'pazjenti kkurati b'Votubia (ara sezzjoni 4.8).