FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of foetuses with cardiovascular/skeletal anomalies.
Maltese: Il-livell tad-doża ta' 1800 mg/kg/ġurnata indotta tossiċità materna sostanzjali u tnaqqis fil-piż tal-fetu assoċjat ma' tnaqqis fl-inċidenza ta' feti b'anormalitajiet kardjovaskolari/skeltrali.
English: Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Maltese: Levetiracetam u sustanzi relatati oħra juru affinità li jeħlu mal-proteina tal-bużżieqa tas-sinapsi 2A b'rata li tikkorralata mal-qawwa tal-protezzjoni li jagħtu kontra l-aċċessjonijiet fil-mudell tal-epilessija awdjoġeniku fil-ġurdien.
English: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet that is to say essentially `sodium-free ´.
Maltese: Sodium Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola miksija b'rita, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Maltese: Terapija miżjuda fit-trattament ta' aċċessjonijiet ġeneraliżżati primarji tat-tip tonic-clonic f'adulti u adoloxxenti minn 12-il sena b'epilessija ġeneralizzata idjopatika.
English: Serum Creatinine (mg/dl)
Maltese: CLcr (ml/min)
English: Each film-coated tablet contains 1,000 mg levetiracetam.
Maltese: Kull pillola miksija b'rita fiha 1,000 mg levetiracetam.
English: More than half of the subjects remained seizure free for 12 months (56.6 % and 58.5 % of subjects on levetiracetam and on carbamazepine CR respectively).
Maltese: Iżjed min-nofs il-pazjenti baqaw mingħajr aċċessjonijet għal 12-il xahar ( 56.6 % u 58.5 % tal-pazjenti fuq levetiracetam u fuq carbamazepine CR rispettivament).
English: A significant correlation between saliva and plasma concentrations has been shown in adults and children (ratio of saliva/plasma concentrations ranged from 1 to 1.7 for oral tablet formulation and after 4 hours post-dose for oral solution formulation).
Maltese: (proporzjon ta' konċentrazzjonijiet fil-bżieq/plażma kienu f'medda ta' bejn 1 sa 1.7 b'pillola orali u wara 4 sigħat wara d-doża b'soluzzjoni orali).
English: Hypromellose 6 cp, Titanium dioxide (E171), Macrogol 3350, Indigotine (E132), Tartrazine (E102), Iron oxide yellow (E172)
Maltese: Hypromellose 6 cp, Titanium dioxide (E 171), Macrogol 3350, Brilliant blue FCF (E132), Tartrazine (E102), Iron oxide yellow (E172)
English: (4)Following dialysis, a 3.5 to 7 mg/kg supplemental dose is recommended.
Maltese: (4)Wara d-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 3.5 u 7 mg/kg.
English: In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 5 days.
Maltese: F'pazjenti pedjatriċi (ta' età ta' xahar sa inqas minn 4 snin), l-effikaċja ta' levetiracetam kienet stabbilita fi studju kkontrollat mill-plaċebo u double-blind li inkludew 116-il pazjent u kellu tul ta' trattament ta' 5 tijiem.
English: Levetiracetam Teva 750 mg film-coated tablets EU/1/11/701/015
Maltese: Levetiracetam Teva 750 mg pilloli miksija b'rita EU/1/11/701/015
English: Levetiracetam Teva 1000 mg film-coated tablets Each film-coated tablet contains 1000 mg levetiracetam.
Maltese: Levetiracetam Teva 1000 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 1000 mg levetiracetam.
English: 5 to 10 mg/kg twice daily
Maltese: 5 sa 10 mg/kg darbtejn kuljum
English: With continued long-term treatment, 8.6 % of the patients were seizurefree for at least 6 months and 7.8 % were seizure-free for at least 1 year.
Maltese: B'trattament kontinwu fit-tul, 8.6 % tal-pazjenti kienu mingħajr aċċessjonijiet għal mill-inqas 6 xhur u
English: Levetiracetam Teva 500 mg film-coated tablets EU/1/11/701/008
Maltese: Levetiracetam Teva 500 mg pilloli miksija b'rita EU/1/11/701/008
English: Antiepileptic medicinal products
Maltese: 3. GĦAMLA FARMAĊEWTIKA
English: Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms.
Maltese: fil-fwied ma jgħinux il-produzzjoni ta' ucb L057, li huwa l-prodott ewlieni tal-metaboliżmu.
English: • swelling of the face, lips, tongue and throat (Quincke's oedema)
Maltese: • Nefħa fil-wiċċ, xofftejn, ilsien u ġerżuma (edima ta' Quincke)
English: Each film-coated tablet contains 750 mg levetiracetam.
Maltese: Kull pillola miksija b'rita fiha 750 mg levetiracetam.
English: • Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Maltese: • Doża fit-trabi (xahar sa 23 xahar), fit-tfal (2 sa 11-il sena) u adoloxxenti (12 sa 17-il sena) li jiżnu inqas minn 50 kg:
English: Levetiracetam Teva 250 mg film-coated tablets EU/1/11/701/001
Maltese: Levetiracetam Teva 250 mg pilloli miksija b'rita EU/1/11/701/001
English: *The colourants are: 250 mg film-coated tablets: brilliant blue FCF (E133) and indigotine (E132).
Maltese: *Il-koloranti huma: 250 mg pilloli miksija b'rita: brilliant blue FCF (E133) u indigotine (E132). 500 mg pilloli miksija b'rita: indigotine (E132), tartrazine (E102) u iron oxide yellow (E172).
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/kg twice daily every two weeks).
Maltese: F'adulti u adoloxxenti li jiżnu iżjed minn 50 kg: tnaqqis ta' 500 mg darbtejn kuljum kull ġimagħtejn sa erba ġimgħat; f'trabi akbar minn 6 xhur, tfal u adoloxxenti li jiżni inqas minn 50 kg: it-tnaqqis fid-doża m'għandiex taċċedi 10 mg/kg darbtejn kuljum kull ġimagħtejn; f'trabi (ta' inqas minn 6 xhur): ittnaqqis fid-doża m'għandiex taċċedi 7 mg/kg darbtejn kuljum kull ġimagħtejn.
English: (5)Following dialysis, a 5 to 10 mg/kg supplemental dose is recommended.
Maltese: (5)Wara d-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 5 u 10 mg/kg.
English: Monotherapy for adults and adolescents from 16 years of age
Maltese: Monoterapija għal adulti u adoloxxenti minn 16-il sena 'l fuq
English: Levetiracetam Teva 500 mg film-coated tablets
Maltese: Levetiracetam Teva 500 mg fih Sodium
English: Debossed with "7286" on the other side of the tablet.
Maltese: Hemm imnaqqax “7286” fuq in-naħa l-oħra tal-pillola.
English: • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Maltese: • Jekk inti allerġiku għal levetiracetam, derivattivi ta' pyrrolidone jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Levetiracetam Teva 750 mg film-coated tablets levetiracetam
Maltese: Levetiracetam Teva 750 mg pilloli miksija b'rita levetiracetam
English: basis) and 1200 mg/kg/day for foetuses.
Maltese: fuq bażi ta' mg/m2) u 1200 mg/kg/ġurnata għal feti.
English: Dosing adjustment for adult and adolescent patients weighing more than 50 kg with impaired renal function:
Maltese: Regolar tad-doża f'pazjenti adulti u adoloxxenti li jiżnu iżjed minn 50kg b'indeboliment fil-kliewi:
English: An oral solution is the preferred formulation for use in this population.
Maltese: Soluzzjoni orali hija l-formulazzjoni preferuta għall-użu f'din il-popolazzjoni.
English: Excipient with known effect: Each film-coated tablet contains 0.06 mg colouring agent tartrazine (E102).
Maltese: Kull pillola miksija b'rita fiha 0.06 mg ta' sustanza koloranti tartrazine (E102).
English: Levetiracetam Teva contains Sodium
Maltese: Jekk tieħu Levetiracetam Teva aktar milli suppost
English: Rare: may affect up to 1 in 1,000 people • infection;
Maltese: Rari: jista' jaffettwa sa 1 f'1,000 persuna
English: • signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
Maltese: • Sinjali ta' tibdil serju mentali jew jekk xi ħadd madwarek jinnota sinjali ta' konfużjoni, nagħas,amneżija (telf ta' memorja), impediment tal-memorja (tinsa), aġir abnormali jew xi sinjali newroloġiċi oħrajn inkuż movimenti involontarji jew mhux ikkontrollati.
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 webportal.
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 kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Tartrazine
Maltese: Pożoloġija
English: Levetiracetam Teva 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam.
Maltese: Levetiracetam Teva 250 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 250 mg levetiracetam.
English: Levetiracetam Teva 1,000 mg film-coated tablets levetiracetam
Maltese: Levetiracetam Teva 1,000 mg pilloli miksija b'rita levetiracetam
English: What you need to know before you take Levetiracetam Teva Do not take Levetiracetam Teva
Maltese: F'każi ta' alopeċja, kien osservat irkupru meta twaqqaf levetiracetam.
English: Each film-coated tablet contains 250 mg levetiracetam.
Maltese: Kull pillola miksija b'rita fiha 250 mg levetiracetam.
English: In this study, levetiracetam dose was 3000 mg/day for adults and adolescents or 60 mg/kg/day for children, given in 2 divided doses.
Maltese: levetiracetam kienet ta' 3000 mg/ġurnata fl-adulti u l-adoloxxenti jew 60 mg/kg/ġurnata fit-tfal, li ingħataw f'2 dożi separati.
English: Debossed with "7287" on the other side of the tablet.
Maltese: Hemm imnaqqax “7287” fuq in-naħa l-oħra tal-pillola.
English: • a more severe form of rash causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis)
Maltese: • Raxx iżjed severa li tikkawża t-tqaxxir tal-ġilda f'iżjed minn 30% tal-wiċċ tal-ġilda (nekrożi tossika epidermali)
English: The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
Maltese: In-NOAEL kien ta' ≥ 1800 mg/kg/ġurnat għal firien feminili F0, u għassopravivenza, kobor u l-iżvilupp taż-żrameġ F1 sa kemm jibdew jieklu weħedhom ( x6 il-MRHD fuq bażi ta'mg/m2).
English: Debossed with "7285" on the other side of the tablet.
Maltese: Hemm imnaqqax“7285” fuq in-naħa l-oħra tal-pillola.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew derivattivi oħrajn ta' pyrrolidone, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Maltese: Reazzjoni għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS),
English: The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily.
Maltese: Id-doża tal-bidu għal tifel jew adoloxxenti ta' 25 kg għandha tkun 250 mg darbtejn kuljum b'doża massima ta' 750 mg darbtejn kuljum.
English: 5 to 15 mg/kg twice daily
Maltese: 5 sa 15 mg/kg (0.05 sa 0.15 ml/kg) darbtejn kuljum
English: Levetiracetam Teva 500 mg contains the colouring agent tartrazine (E102) that may cause allergic reactions.
Maltese: Levetiracetam Teva 500 mg fih Tartrazine (E102) sustanza li tgħati l-kulur tista' tikkawża reazzjonijiet allerġiċi.
English: (3)A 15 mg/kg loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: (3)Doża inizjali ta' 15 mg/kg hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: Treatment of an overdose will be symptomatic and may include haemodialysis.
Maltese: It-tabib tiegħek ser jiddeċiedi l-aħjar trattament possibbli għat-trattament tal-overdose.
English: Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Maltese: Terapija miżjuda fit-trattament ta' aċċessjonijiet mijokloniċi f'adulti u adoloxxenti min 12-il sena b'epilessija mijoklonika li tibda fiż-żgħożija.
English: Epilepsy is a condition where the patients have repeated fits (seizures).
Maltese: L-epilessija hija kundizzjoni fejn il-pazjent ikollu aċċessjonijiet ripetuti.
English: EU/1/11/701/022 30 film-coated tablets EU/1/11/701/023 50 film-coated tablets EU/1/11/701/024 50x1 film-coated tablet EU/1/11/701/025 60 film-coated tablets EU/1/11/701/026 100 film-coated tablets EU/1/11/701/027 120 film-coated tablets EU/1/11/701/028 200 film-coated tablets EU/1/11/701/032 20 film-coated tablets
Maltese: EU/1/11/701/022 30 pillola miksija b'rita EU/1/11/701/023 50 pillola miksija b'rita EU/1/11/701/024 50x1 pillola miksija b'rita EU/1/11/701/025 60 pillola miksija b'rita EU/1/11/701/026 100 pillola miksija b'rita EU/1/11/701/027 120 pillola miksija b'rita EU/1/11/701/028 200 pillola miksija b'rita EU/1/11/701/032 20 pillola miksija b'rita
English: Add-on therapy for infants aged from 1 month to less than 6 months
Maltese: Terapija miżjuda fi trabi minn età ta' xagħar sa inqas minn 6 xhur
English: Orange, oblong shaped, film-coated tablets, scored on one side and debossed with "9" on one side of the score and with "3" on the other side of the score.
Maltese: Pilloli f'għamla ta' oblong ta' lewn oranġjo, miksija b'rita b'xaqq imnaqqax fin-nofs b'naħa waħda hemm imnaqqax “9” u fuq in-naħa l-oħra “3”.
English: In both population pharmacokinetic analyses, there was about a 20 % increase of apparent clearance of levetiracetam when it was co-administered with an enzyme-inducing antiepileptic medicinal product.
Maltese: Fiż-żewġ analiżi tal-farmakokinetika fil-popolazzjoni, kien hemm żieda ta' madwar 20 % fil-tneħħija li tidher ta' levetiracetam meta ngħatat flimkien mal-prodott mediċinali ta' kontra l-epilessija li jindotta l-enżimi.
English: EU/1/11/701/001 30 film-coated tablets EU/1/11/701/002 50 film-coated tablets EU/1/11/701/003 50x1 film-coated tablet EU/1/11/701/004 60 film-coated tablets EU/1/11/701/005 100 film-coated tablets EU/1/11/701/006 120 film-coated tablets EU/1/11/701/007 200 film-coated tablets EU/1/11/701/029 20 film-coated tablets
Maltese: EU/1/11/701/001 30 pillola miksija b'rita EU/1/11/701/002 50 pillola miksija b'rita EU/1/11/701/003 50x1 pillola miksija b'rita EU/1/11/701/004 60 pillola miksija b'rita EU/1/11/701/005 100 pillola miksija b'rita EU/1/11/701/006 120 pillola miksija b'rita EU/1/11/701/007 200 pillola miksija b'rita EU/1/11/701/029 20 pillola miksija b'rita
English: The possible side effects of an overdose of Levetiracetam Teva are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Maltese: Wara dożi eċċessivi ta' levetiracetam, ġew osservati effetti ta' ħedla, aġitazzjoni, aggressjoni, tnaqqis fil-livell ta' kuxjenza, livell baxx tar-rifless respiratorju, u koma.
English: EU/1/11/701/008 30 film-coated tablets EU/1/11/701/009 50 film-coated tablets EU/1/11/701/010 50x1 film-coated tablet EU/1/11/701/011 60 film-coated tablets EU/1/11/701/012 100 film-coated tablets EU/1/11/701/013 120 film-coated tablets EU/1/11/701/014 200 film-coated tablets EU/1/11/701/030 20 film-coated tablets
Maltese: EU/1/11/701/008 30 pillola miksija b'rita EU/1/11/701/009 50 pillola miksija b'rita EU/1/11/701/010 50x1 pillola miksija b'rita EU/1/11/701/011 60 pillola miksija b'rita EU/1/11/701/012 100 pillola miksija b'rita EU/1/11/701/013 120 pillola miksija b'rita EU/1/11/701/014 200 pillola miksija b'rita EU/1/11/701/030 20 pillola miksija b'rita
English: • as an add-on to other antiepileptic medicines to treat: ■ partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age ■ myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy ■ primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Maltese: • fit-trattament ta' aċċessjonijiet tat-tip parzjali kemm meta jkun hemm, kif ukoll meta ma jkunx hemm ġeneralizzazzjoni sekondarja f'adulti, adoloxxenti, tfal u trabi minn età ta' xahar b'epilessija.
English: Do not use this medicine after the expiry date stated on the carton box and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kaxxa u l-folja, wara EXP.
English: EU/1/11/701/015 30 film-coated tablets EU/1/11/701/016 50 film-coated tablets EU/1/11/701/017 50x1 film-coated tablet EU/1/11/701/018 60 film-coated tablets EU/1/11/701/019 100 film-coated tablets EU/1/11/701/020 120 film-coated tablets EU/1/11/701/021 200 film-coated tablets EU/1/11/701/031 20 film-coated tablets
Maltese: EU/1/11/701/015 30 pillola miksija b'rita EU/1/11/701/016 50 pillola miksija b'rita EU/1/11/701/017 50x1 pillola miksija b'rita EU/1/11/701/018 60 pillola miksija b'rita EU/1/11/701/019 100 pillola miksija b'rita EU/1/11/701/020 120 pillola miksija b'rita EU/1/11/701/021 200 pillola miksija b'rita EU/1/11/701/031 20 pillola miksija b'rita
English: An oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Maltese: Soluzzjoni orali hija l-formulazzjoni preferuta għall-użu fi tfal li għadhom m'għalqux 6 snin.
English: Levetiracetam Teva 250 mg film-coated tablets
Maltese: Levetiracetam Teva 250 mg pilloli miksija b'rita
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
Maltese: • Raxx mifrux bil-bżieżaq u ġilda titqaxxar, partikularment madwar il-ħalq, imnieħer, għajnejn u ġenitali (sindromu Stevens-Johnson)
English: Blue, oblong shaped, film-coated tablets, scored on one side and debossed with "9" on one side of the score and with "3" on the other side of the score.
Maltese: Pilloli f'għamla ta' oblong ta' lewn blu, miksija b'rita b'xaqq imnaqqax fin-nofs b'naħa waħda hemm imnaqqax “9” u fuq in-naħa l-oħra “3”.
English: 72 x serum creatinine (mg/dl)
Maltese: Clcr (ml/min) = ------------------------------------------------ (x 0.85 għan-nisa) 72 x livell ta' kreatinina fis-serum (mg/dl)
English: The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme induction is expected in vivo.
Maltese: Tagħrif in vitro u tagħrif dwar l-interazzjoni in vivo fuq kontraċettivi orali, digoxin u warfarina jindika li mhux mistenni li jkun hemm induzzjoni sinifikanti tal-enżimi in vivo.
English: • convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
Maltese: • aċċessjonijiet, mard tal-bilanċ (mard tal-ekwilibru), sturdament (sensazzjoni ta' ċaqliq), telqa
English: Hyponatraemia
Maltese: epatite
English: Levetiracetam Teva 1,000 mg film-coated tablets
Maltese: Levetiracetam Teva 1,000 mg pilloli miksija b'rita
English: At 3600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Maltese: B'3600 mg/kg/ġurnata, fi studju wieħed miż-żewġ studji EFD,kien hemm tnaqqis żgħir fil-piż tal-fetu marbut ma' żieda marġinali f'varjazzjonijiet skeletali/ anormalitajiet minuri.
English: A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
Maltese: Studju retrospettiv ta' interazzjoni farmakokinetika fit-tfal u l-adoloxxenti b'epilessija (4 sa 17-il sena)
English: Levetiracetam Teva is indicated as adjunctive therapy
Maltese: Il-mod prinċipali kif jiġi metabolizzat
English: Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Maltese: 250 mg u 2 pilloli ta' 250 mg filgħaxija.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Tul (ċm) x ks
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Prodotti mediċinali ta' kontra l-epilessija
English: 250 to 750 mg twice daily
Maltese: 500 sa 1,000 mg darbtejn kuljum250 sa 750 mg darbtejn kuljum250 sa 500 mg darbtejn kuljum
English: Levetiracetam Teva 750 mg film-coated tablets
Maltese: Levetiracetam Teva 750 mg pilloli miksija b'rita
English: End-stage renal disease patients undergoing dialysis (1)
Maltese: Pazjenti fl-aħħar stadji tal-marda tal kliewi li jagħmlu d-dijaliżi(1)
English: The renal clearance of levetiracetam and ucb L057 is 0.6 and 4.2 ml/min/kg respectively indicating that levetiracetam is excreted by glomerular filtration with subsequent tubular reabsorption and that the primary metabolite is also excreted by active tubular secretion in addition to glomerular filtration.
Maltese: It-tneħħija ta' levetiracetam fit-tfal kienet 30 % iżjed minn dik f'adulti li jbatu mill-epilessija meta ġiet ikkonsidrata d-differenza fil-piż. Levetiracetam kien assorbit malajr fi tfal b'epilessija (4 sa 12-il sena) wara li ingħataw doża orali repetuta (20 sa 60 mg/kg/day).
English: Levetiracetam Teva 1000 mg film-coated tablets
Maltese: Levetiracetam Teva 1000 mg pilloli miksija b'rita
English: It is available as tablets (5, 10, 15 and 20 mg).
Maltese: Jiġi bħala pilloli (5, 10, 15 u 20 mg).
English: The full EPAR for Jakavi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Jakavi ruxolitinib
Maltese: Jakavi ruksolitinib
English: This summary was last updated in 03-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 03-2015.
English: Other information about Jakavi
Maltese: Informazzjoni oħra dwar Jakavi
English: Jakavi is a medicine that contains the active substance ruxolitinib.
Maltese: Jakavi huwa mediċina li fiha s-sustanza attiva r-ruksolitinib.
English: This is a summary of the European public assessment report (EPAR) for Jakavi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Jakavi.
English: In polycythaemia vera, 21% (23 out of 110) of patients given Jakavi showed an improvement after 8 months of treatment, compared with 1% (1 out of 112) of patients given the best available treatment.
Maltese: Fil-poliċitemija vera, 21% (23 minn 110) tal-pazjenti li ngħataw Jakavi wrew titjib wara 8 xhur ta' kura, meta mqabbla ma' 1% (1 minn 112) tal-pazjenti li ngħataw l-aħjar kura disponibbli.
English: In the first study, the target reduction in spleen size was achieved in 42% of patients treated with Jakavi (65 out of 155) compared with less than 1% of patients given placebo (1 out of 153).
Maltese: Fl-ewwel studju, it-tnaqqis fil-mira fid-daqs tal-milsa nkiseb fi 42% tal-pazjenti kkurati b'Jakavi (65 minn 155) meta mqabbla ma' inqas minn 1% tal-pazjenti li ngħataw il-plaċebo (1 minn 153).