FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of everolimus for up to 2 years did not indicate any oncogenic potential in mice and rats up to the highest doses, corresponding respectively to 4.3 and 0.2 times the estimated clinical exposure.
Maltese: L-għoti ta' everolimus sa sentejn ma indikax potenzjal onkoġeniku fil-ġrieden u l-firien sal-ogħla dożi, li jikkorrispondi rispettivament għal 4.3 u 0.2 drabi l-esponiment kliniku stmat.
English: Consistent treatment effects on angiomyolipoma response rate were observed across all subgroups evaluated (i.e. enzyme-inducing antiepileptic use versus enzyme-inducing antiepileptic non-use, sex, age and race) at the primary efficacy analysis.
Maltese: Kienu osservati effetti konsistenti fuq ir-rata ta' rispons tal-anġjomijolipoma b'rabta mat-trattament fost is-sottogruppi evalwati (i.e. użu ta' antiepilettiċi li jinduċu l-enzimi kontra n-nuqqas ta' użu ta' antiepilettiċi li jinduċu l-enzimi, sess, età u razza) waqt l-analiżi tal-effikaċja finali.
English: Women of childbearing potential must use a highly effective method of contraception (e.g. oral, injected, or implanted non-oestrogen-containing hormonal method of birth control, progesterone-based contraceptives, hysterectomy, tubal ligation, complete abstinence, barrier methods, intrauterine device [IUD], and/or female/male sterilisation) while receiving everolimus, and for up to 8 weeks after ending treatment.
Maltese: Nisa li jistgħu joħorġu tqal għandhom jużaw metodu mill-aktar effettiv ta' kontraċezzjoni (eż. orali, injezzjoni, metodu ppjantat ta' ta' kontroll tat-twelid ormonali li ma fihiex estroġenu, kontraċettivi li fihom il-proġesteronu, isteroktomija, irbit tat-tubi, astinenza totali, metodi ta' barriera, apparat intrauterali
English: High level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides) Low level of phosphate in the blood (hypophosphataemia) High level of sugar in the blood (hyperglycaemia) Tiredness, breathlessness, dizziness, pale skin (signs of low level of red blood cells, also known as anaemia)
Maltese: Livell għoli ta' lipidi (xaħmijiet) fid-demm (iperlipidimja, żieda fit-trigliċeridi) Livell baxx ta' fosfat fid-demm (ipofosfatemija) Livell għoli ta' zokkor fid-demm (ipergliċemija) Għeja, qtugħ ta' nifs, sturdament, ġilda pallida (sinjali ta' livell baxx ta' ċelluli ħomor taddemm, magħrufa wkoll bħala anemija)
English: The p-values for superiority versus placebo were 0.003 (LT) and <0.001 (HT).
Maltese: Il-valuri p għas-superjorità meta mqabbel mal-plaċebo kienu ta' 0.003 (LT) u <0.
English: Further dose reduction may be required to manage adverse reactions (see sections 4.2 and 4.4).
Maltese: Jista' jkun hemm bżonn li titnaqqas aktar id-doża sabiex wieħed jikkontrolla rreazzjonijiet avversi (ara sezzjonijiet 4.2 u 4.4).
English: The potential for everolimus to cause infertility in male and female patients is unknown, however secondary amenorrhoea and associated luteinising hormone (LH)/follicle stimulating hormone (FSH) imbalance has been observed in female patients (see also section 5.3 for preclinical observations on the male and female reproductive systems).
Maltese: Il-potenzjalità għal everolilmus li jikkawża infertilità f'pazjenti rġiel u nisa mhijiex magħrufa, madanakollu kien osservat żbilanċ fl-amenorrea sekondarja u fl-ormon luteinizzanti assoċjat (LH)/ormon li jistimula l-follikulu f'pazjenti nisa (ara wkoll sezzjoni 5.3 għal osservazzjonijiet ta' qabel l-użu kliniku fuq is-sistema riproduttiva tal-irġiel u n-nisa).
English: Concomitant treatment with potent CYP3A4 inhibitors result in dramatically increased blood concentrations of everolimus (see section 4.5).
Maltese: Meta l-kura tingħata flimkien ma' impedituri potenti ta' CYP3A4 din twassal għal żieda kbira filkonċentrazzjonijiet ta' everolimus fid-demm (ara sezzjoni 4.5).
English: higher starting dose of 7 mg/m is recommended for patients 1 to less than 3 years of age based on pharmacokinetic simulations (see section 5.2).
Maltese: Hi rrakkomandata doża ogħla li tibda minn 7 mg/m għal pazjenti li għandhom minn sena sa anqas minn 3 snin skont is-simulazzjonijiet farmakokinetiċi (ara sezzjoni 5.2).
English: Based on analysis of population pharmacokinetics, oral clearance (CL/F) is on average 20% higher in black transplant patients.
Maltese: Fuq bażi ta' analiżi farmakokinetika tal-popolazzjoni, tneħħija orali (CL/F) hija ta' madwar 20% ogħla f'pazjenti suwed bi trapjant.
English: The everolimus trough concentration should be assessed at least 1 week later (see sections 4.2 and 4.4).
Maltese: L-inqas konċentrazzjoni ta' everolimus għandha tkun evalwata mill-inqas ġimgħa wara (ara sezzjonijiet 4.2 u 4.4).
English: Estimated progression-free rates at 6 months were 98.4% for the everolimus arm and 83.4% for the placebo arm. At the final analysis, median time to angiomyolipoma progression was not reached.
Maltese: Rati stmati liberi mill-progressjoni fis-6 xahar kienu 98.4% għall-grupp mogħti everolimus u ta' 83.4% għall-grupp mogħti l-plaċebo.
English: Includes (very common) rash; (common) rash erythematous, erythema and (uncommon) rash generalised, rash maculo-papular, rash macular d
Maltese: Jinkludi (komuni ħafna) raxx; (komuni) raxx b'eritema, eritema u (mhux komuni) raxx ġeneralizzat, raxx makulo-papulari, raxx makulari d
English: Seizure-free
Maltese: Żid l-ilma
English: Key secondary endpoints in hierarchal order of testing included the absolute change in frequency of total seizure events per 24-hour EEG from baseline to week 24, time to SEGA progression, and skin lesion response rate.
Maltese: L-endpoints sekondarji ewlenin skont ordni ġerarkika ta' valutazzjoni kienu jinkludu l-bidla assoluta fil-frekwenza totali ta' episodji ta' attakki għal kull 24 siegħa ta' EEC mil-linja bażi sal-24 ġimgħa, żmien sal-progressjoni ta' SEGA, u rata ta' rispons ta' feriti fil-ġilda.
English: Use caution when co-administration of moderate CYP3A4 inhibitors or PgP inhibitors cannot be avoided.
Maltese: Madanakollu, mhuwiex eskluż li jkun hemm impediment ta' CYP3A4 u ta' PgP fl-imsaren.
English: Phase II study in patients with SEGA
Maltese: III fost pazjenti b'SEGA
English: Range
Maltese: Rimi
English: Packs containing 30 x 1 dispersible tablets.
Maltese: Pakketti li fihom 30 x 1 pillola li tinxtered.
English: Grade 3 & 4 (<50x10
Maltese: Grad 3 & 4 (<1, ≥0.
English: The median duration of blinded study treatment was 9.6 months (range: 5.5 to 18.1) for patients receiving Votubia and 8.3 months (range: 3.2 to 18.3) for those receiving placebo.
Maltese: Id-dewmien medjan tat-trattament waqt l-istudju blinded kien ta' 9.6 xhur (medda: bejn 5.5 u 18.1) fost pazjenti mogħtija Votubia u ta' 8.3 xhur (medja: bejn 3.2 u 18.3) fost dawk mogħtija plaċebo.
English: In the everolimus treated population (N=111) of the study, including patients who crossed over from the placebo group, tumour response, starting as early as after 12 weeks on everolimus, was sustained at later time points.
Maltese: Fil-popolazzjoni kkurata b'everolimus (N=111) tal-istudju, inklużi pazjenti li qalbu mill-grupp talplaċebo, ir-rispons għal tumur, li beda sa minn kmieni wara 12-il ġimgħa fuq everolimus, kien sostnut f'mumenti aktar tard.
English: Interrupt Votubia until symptoms resolve to Grade 1.
Maltese: Waqqaf Votubia sakemm is-sintomi jitjiebu għal ≤ Grad 1.
English: There was a significant correlation between AUC0-τ and pre-dose trough concentration at steady-state.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl u millumdità.
English: The mean elimination half-life of everolimus is approximately 30 hours.
Maltese: Il-half-life medja ta' eliminazzjoni hija ta' madwar 30 siegħa.
English: This outcome was consistent with the results of a linear regression model predicting the log of absolute seizure frequency during the maintenance period of the core phase, which indicated that for a 2-fold increase in TN-Cmin there was a statistically significant 28% reduction (95% CI: 12%, 42%) in absolute seizure frequency.
Maltese: Dan l-eżitu kien konsistenti marriżultati tal-mudell ta' rigressjoni lineari li jbassru r-reġistru tal-frekwenza tal-attakki epilettiċi assolutra matul il-perjodu ta' manutenzjoni tal-fażi ewlenija, li wriet li għal kull żieda doppja fit-TNCmin kien hemm tnaqqis sinjifikanti statistikament ta' 28% (95% CI: 12%, 42%) fil-frekwenza talattakki epilettiċi assoluti.
English: Starting dose without co-administration of CYP3A4/PgP inducer
Maltese: Doza inizjali mal-għoti flimkien tal-induttur CYP3A4/PgP
English: Respiratory, thoracic and mediastinal disorders Very common Cough
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna Sogħla Komuni
English: Each Votubia 10 mg tablet contains 10 mg of everolimus.
Maltese: Kull pillola ta' Votubia 10 mg fiha 10 mg ta' everolimus.
English: Each dispersible tablet contains 1 mg everolimus.
Maltese: Kull pillola li tinxtered fiha 1 mg everolimus.
English: You will have blood tests during treatment with Votubia.
Maltese: Isirulek testijiet tad-demm waqt it-trattament b'Votubia.
English: Reactivation of infection is an expected reaction during periods of immunosuppression.
Maltese: Attivazzjoni mill-ġdid tal-infezzjonijiet hija reazzjoni mistennija matul perijodi ta' immunosuppressjoni.
English: Temporary dose interruption until recovery to Grade 2 (≥1x10
Maltese: Interrompi d-doża temporanjament sakemm ikun hemm titjib f' Grad 2 (≥1x10
English: • Severe hepatic impairment (Child-Pugh C): Votubia is only recommended if the desired benefit outweighs the risk.
Maltese: • Indeboliment qawwi tal-fwied (Child-Pugh C): Votubia huwa rakkomandat biss jekk il benefiċċju mixtieq huwa akbar mir-riskju.
English: Genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of clastogenic or mutagenic activity.
Maltese: Studji ta' tossiċità tal-ġeni li inkludew punti aħħarin ta' tossiċità tal-ġeni rilevanti ma wrew l-ebda evidenza ta' attività klastoġenika jew mutaġenika.
English: White to slightly yellow, elongated tablets of approximately 12.1 x 4.9 mm, with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other.
Maltese: Pilloli minn bojod sa kemxejn sofor, tawwalin ta' madwar 12.1 x 4.9 mm, b'ġenb tasturat u bl-ebda sinjal dritt, imnaqqxin b'“5” fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: • ≥18 years of age and concomitant severe hepatic impairment (Child-Pugh C) unless the potential benefit outweighs the risk (see sections 4.2 and 5.2).
Maltese: • ta' ≥18-il sena u fl-istess ħin indeboliment qawwi tal-fwied (Child-Pugh Ċ) sakemm il benefiċċju potenzjali ma jkunx akbar mir-riskju (ara sezzjonijiet 4.2 u 5.2).
English: Votubia 5 mg tablets are white to slightly yellowish, elongated tablets.
Maltese: Votubia 5 mg pilloli huma minn bojod sa kemxejn sofor, tawwalin.
English: Each Votubia 2.5 mg tablet contains 2.5 mg of everolimus.
Maltese: Kull pillola ta' Votubia 2.5 mg fiha 2.5 mg ta' everolimus.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Instructions for caregivers preparing the suspension using an oral syringe:
Maltese: Istruzzjonijiet għall-persuni li qed jieħdu ħsieb il-pazjent dwar il-preparazzjoni tas-suspensjoni bl-użu ta' siringa orali:
English: At the time of the primary analysis, Votubia demonstrated clinically meaningful improvements in skin lesion response (p=0.0004), with response rates of 41.7% (95% CI: 30.2, 53.9) for the Votubia arm and 10.5% (95% CI: 2.9, 24.8) for the placebo arm. At the final analysis, the skin lesion response rate increased to 58.1% (95% CI: 48.1, 67.7).
Maltese: Fil-mument tal-analiżi primarja, Votuba wera titjib sinjifikanti klinikament fir-rispons ta' feriti talġilda (p=0.0004) b'rati ta' rispons ta' 41.7% (95% CI: 30.2, 53.9) għall-grupp mogħti Votubia u ta' 10.
English: If co-administration of a moderate CYP3A4 and/or PgP inhibitor or inducer cannot be avoided, dose adjustments of Votubia may be required (see section 4.5).
Maltese: Jekk ma jistax jiġi evitat li CYP3A4 moderat u/jew limpeditur jew l-induttur PgP jingħataw flimkien, jista' jkun hemm bżonn li tkun aġġustata d-doża ta' Votubia (ara sezzjoni 4.5).
English: Infections and infestations Very common Nasopharyngitis, upper respiratory tract infection, pneumonia a, urinary tract infection, sinusitis, pharyngitis
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna Nażofarinġite, infezzjoni fl-apparat respiratorju ta' fuq, pulmonite a, infezzjoni fl apparat tal-awrina, sinożite, farinġite
English: Votubia 1 mg dispersible tablets Votubia 2 mg dispersible tablets Votubia 3 mg dispersible tablets Votubia 5 mg dispersible tablets
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
English: Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 x 1 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Aluminju/poliamide/aluminju/folja mtaqqba ta' doża waħda tal-PVC li fiha 10 x 1 pilloli.
English: Month 6 n=27
Maltese: Xahar n=27
English: Table 8 Change in primary SEGA volume over time
Maltese: Tabella 8 Bidla fil-volum primarju ta' SEGA matul iż-żmien
English: They are engraved with “D5” on one side and “NVR” on the other.
Maltese: Huma mnaqqxin b'“D5” fuq naħa waħda u b'“NVR” fuq in-naħa l-oħra.
English: Each dispersible tablet contains 2 mg everolimus.
Maltese: Kull pillola li tinxtered fiha 2 mg everolimus.
English: Potent and moderate CYP3A4 inducers Rifampicin
Maltese: Impedituri moderati ta' CYP3A4/PgP Erythromycin
English: In an exploratory analysis of patients with TSC with angiomyolipoma who also had SEGA, the SEGA response rate (proportion of patients with ≥50% reduction from baseline in target lesion volumes in the absence of progression) was 10.3% in the everolimus arm in the primary analysis (versus no responses reported in the 13 patients randomised to placebo with a SEGA lesion at baseline) and increased to 48.0% in the final analysis.
Maltese: 3% fil-fergħa tal-everolimus fil-analiżi primarja (apparagun mal-fatt li l-ebda rispons ma ġie rrappurtat fit-13-il pazjent magħżula b'mod arbitrarju għall-plaċebo b'leżjoni tas-SEGA fil-linja bażi) u żdied għal 48.0% fl-analiżi finali.
English: Patients with SEGA associated with TSC:
Maltese: Pazjenti b'SEGA assoċjata ma' TSC:
English: Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 x 1 dispersible tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Aluminju/poliamide/aluminju/folja mtaqqba ta' doża waħda tal-PVC li fiha 10 x 1 pilloli li jinxterdu.
English: Steady-state pharmacokinetics
Maltese: Qlib mill-forom farmaċewtiċi
English: Estimated progression-free rates at 6 months were 100% for the Votubia arm and 85.7% for the placebo arm.
Maltese: Irrati stmati ħielas mill-progressjoni fis-6 xahar kienu 100% għall-grupp mogħti Votubia u ta' 85.7% għall-grupp mogħti l-plaċebo.
English: Uncommon side effects (may affect up to 1 in 100 people) Rash of small fluid-filled blisters, appearing on reddened skin (signs of viral infection that can be potentially severe, also known as herpes zoster) Fever, chills, rapid breathing and heart rate, rash, and possibly confusion and disorientation (signs of serious infection, also known as sepsis)
Maltese: Raxx ta' nfafet żgħar mimlija b'likwidu, li jidhru fuq ġilda ħamra (sinjali ta' infezzjoni kkawżata minn virus li potenzjalment tista' tkun severa, magħruf ukoll bħala herpes zoster) Deni, tertir, nifs u rata tat-taħbit tal-qalb mgħaġġla, raxx, u possibbilment konfużjoni u diżorjentament (sinjali ta' infezzjoni serja, magħrufa wkoll bħala sepsi)
English: Renal angiomyolipoma associated with TSC
Maltese: • Imqass biex tiftaħ il-folja
English: No change >-25 to <25
Maltese: L-ebda bidla >-25 sa <25
English: Patients with renal angiomyolipoma associated with TSC:
Maltese: Il-pilloli Votubia jintużaw biex jittrattaw:
English: Hence everolimus may affect the bioavailability of orally co-administered CYP3A4 substrates.
Maltese: Għaldaqstant, everolimus jista' jaffettwa il-bijodisponibbiltà ta' sustanzi mogħtija flimkien mill-ħalq li huma substrati ta' CYP3A4.
English: Votubia 5 mg tablets are available in packs containing 30 x 1 or 100 x 1 tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Maltese: Il-pilloli Votubia 5 mg huma disponibbli f'pakketti li fihom 30 x 1 jew 100 x 1 pillola f'folji mtaqqbin ta' doża waħda ta' 10 x 1 pillola kull waħda.
English: Each dispersible tablet contains 3 mg everolimus.
Maltese: Kull pillola li tinxtered fiha 3 mg everolimus.
English: • The blister with Votubia dispersible tablets
Maltese: • Folja bil-pilloli li jinxterdu Votubia
English: Votubia 3 mg and Votubia 5 mg dispersible tablets are available in packs containing 30 x 1 or 100 x1 dispersible tablets in perforated unit-dose blisters of 10 x 1 tablets each.
Maltese: Il-pilloli li jinxterdu Votubia ta' 3 mg u ta' 5 mg huma disponibbli f'pakketti li fihom 30 x 1 jew 100 x 1 pillola li jinxterdu f'folji mtaqqbin ta' doża waħda ta' 10 x 1 pillola kull waħda.
English: Following the administration of a single dose of radiolabelled everolimus in conjunction with ciclosporin, 80% of the radioactivity was recovered from the faeces, while 5% was excreted in the urine.
Maltese: Wara l-għoti ta' doża waħda ta' everolimus immarkat bir-raġġi flimkien ma' ciclosporin 80% tar-radjuattività kienet irkuprata mill-ippurgar, filwaqt li 5% kienet imneħħija mal-awrina.
English: They are engraved with “D3” on one side and “NVR” on the other.
Maltese: Huma mnaqqxin b'“D3” fuq naħa waħda u b'“NVR” fuq in-naħa l-oħra.
English: Menstruation disorders such as heavy periods (menorrhagia) or vaginal bleeding Trouble sleeping (insomnia)
Maltese: Disturbi fil-mestrwazzjoni bħal periods qawwija (menorraġija), jew fsada vaġinali Diffikultà biex torqod (insomnja)
English: Primary SEGA volume was reduced at month 6 compared to baseline (p<0.001 [see Table 7]).
Maltese: 001 [ara Tabella 7]).
English: Votubia 1 mg dispersible tablets everolimus
Maltese: Votubia 1 mg pilloli li jinxterdu everolimus
English: Table 1 Votubia dose adjustment recommendations
Maltese: Tabella 1 Rakkomandazzjonijiet dwar aġġustament tad-doża b'Votubia
English: Packs containing 10 x 1, 30 x 1 or 100 x 1 dispersible tablets.
Maltese: Pakketti li fihom 10 x 1, 30 x 1 jew 100 x 1 pillola li tinxtered.
English: Gently stir the contents of the glass with a spoon and then proceed immediately to step 8.
Maltese: Ħawwad bil-mod il-kontenuti fit-tazza b'magħrfa u wara ipproċedi minnufih għal pass 8.
English: Concomitant antiepileptic therapy may affect the metabolism of everolimus and may contribute to this variance (see section 4.5).
Maltese: Terapija antiepilettika konkomitanti tista' taffettwa l-metaboliżmu ta' everolimus u tista' twassal għal din il-varjanza (ara sezzjoni 4.5).
English: It contains an active substance called everolimus which may reduce the size of kidney tumours called renal angiomyolipomas and brain tumours called subependymal giant cell astrocytomas (SEGA).
Maltese: Tiħux Votubia jekk inti allerġiku għal everolimus, għal sustanzi relatati miegħu bħal sirolimus jew temsirolimus, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
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.
Maltese: Madankollu, dożi orali ta' everolimus f'firien femminili ta' ≥0.1 mg/kg (madwar 4% tal-AUC0-24siegħa f'pazjenti li jirċievu d-doża ta' 10 mg kuljum) wasslu għal żidiet fit-telf tal-fetu qabel l-impjantazzjoni.
English: Other non-haematological toxicities (excluding metabolic events)
Maltese: Tossiċitajiet oħrajn mhux ematoloġiċi (esklużi episodji metaboliċi)
English: • EXIST-1 (CRAD001M2301): This was a randomised, double-blind, controlled, phase III trial of everolimus (n=78) versus placebo (n=39) in patients with TSC who have SEGA, irrespective of age.
Maltese: III ta' everolimus (n=78) kontra plaċebo (n=39) f'pazjenti b'TSC li għandhom SEGA, irrispettivament mill-età.
English: Votubia 5 mg dispersible tablets, abbreviated form accepted, if required for technical reasons
Maltese: Votubia 5 mg pilloli li jinxterdu, forma mqassra [pilloli disp] aċċettata, jekk meħtieġa minħabba raġunijiet tekniċi
English: Therapeutic drug monitoring
Maltese: IL-PRODOTT MEDIĊINALI
English: Votubia 3 mg dispersible tablets everolimus
Maltese: Votubia 3 mg pilloli li jinxterdu everolimus
English: Loss of either TSC1 or TSC2 leads to elevated rheb-GTP levels, a ras family GTPase, which interacts with the mTORC1 complex to cause its activation.
Maltese: It-telf ta' TSC1 jew ta' TSC2 iwassal għal żieda fil-livelli rheb-GTP, parti mill-familja ta' ras GTPase, li jinterixxi mal-kumpless mTORC1 biex jikkawża l-attivazzjoni tiegħu.
English: Votubia 5 mg dispersible tablets are white to slightly yellowish, round, flat tablets with a bevelled edge and no score.
Maltese: Votubia 5 mg pilloli li jinxterdu huma minn bojod sa kemxejn sofor, pilloli tondi u ċari b'ġenb tasturat u bl-ebda sinjal dritt.
English: The most common adverse reactions leading to discontinuation were pneumonitis (including interstitial lung disease), fatigue, dyspnoea, and stomatitis.
Maltese: L-aktar reazzjonijiet avversi komuni li wasslu għall-waqfien kienu pulmonite (inkluż marda tal-interstizju tal-pulmun), għeja, qtugħ ta' nifs, u stomatite.
English: Each Votubia 5 mg tablet contains 5 mg of everolimus.
Maltese: Kull pillola ta' Votubia 5 mg fiha 5 mg ta' everolimus.
English: cause mouth sores (oral ulcerations).
Maltese: Infjammazzjoni fil-ġilda (ċellulite)
English: Packs containing 30 x 1 or 100 x 1 tablets.
Maltese: Pakketti li fihom 30 x 1 jew 100 x 1 pillola.
English: White to slightly yellow, elongated tablets of approximately 10.1 x 4.1 mm, with a bevelled edge and no score, engraved with “LCL” on one side and “NVR” on the other.
Maltese: 1 x 4.1 mm, b'ġenb tasturat u bl-ebda sinjal dritt, imnaqqxin b'“LCL” fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (see section 4.4).
Maltese: Il-pazjenti li qed jieħdu fl-istess ħin terapija b'inibitur ta' ACE (eż. ramipril) jistgħu jkunu f'riskju akbar ta' anġjoedima (ara sezzjoni 4.4).
English: The analysis was stratified by use of enzyme-inducing antiepileptics at randomisation (yes/no).
Maltese: L-analiżi kienet stratifikata permezz ta' mediċini antipilettiċi li jinduċu l-enzima waqt irradomizzazzjoni (iva/le).
English: Therefore it is assumed that steady-state could be reached earlier in patients <3 years of age (see section 4.2 for dosing recommendations).
Maltese: Għaldaqstant wieħed jassumi li l-pazjenti li għandhom <3 snin jistgħu jilħqu qagħda stabbli aktar malajr (ara s-sezzjoni 4.2 dwar id-dożi rrakkomandati).
English: Take the 10 ml oral syringe and pull out the plunger, removing it completely from the barrel of the syringe.
Maltese: Ħu s-seringa orali tal-10 ml u iġbed il-planġer, oħorġu kollu minn maċ-ċilindru tas-seringa.
English: Monitoring for and treatment of fungal infection is recommended, especially in patients being treated with steroid-based medicinal products.
Maltese: Hu rrakkomandat monitoraġġ u trattament għal infezzjoni bil-fungu, b'mod speċjali f'pazjenti li qegħdin jiġu ttrattati bi prodotti mediċinali abbażi ta' sterojdi.
English: Constipation, nausea, abdominal pain, flatulence, oral pain, gastritis
Maltese: Telithromycin, clarithromycin Nefazodone Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir