FrancophonIA/ELRC3.0 huggingface dataset:
English: Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam Actavis 1,000 mg film-coated tablets
Maltese: Levetiracetam Actavis 250 mg pilloli miksija b'rita Levetiracetam Actavis 500 mg pilloli miksija b'rita Levetiracetam Actavis 750 mg pilloli miksija b'rita Levetiracetam Actavis 1000mg pilloli miksija b'rita
English: Levetiracetam Actavis 250 mg, 500 mg and 1,000 mg film-coated tablets Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Maltese: Levetiracetam Actavis 250 mg, 500 mg u 1,000 mg pilloli miksija b'rita Folji: 20, 30, 50, 60, 100, 120 u 200 pillola miksija b'rita.
English: Aluminium/PVC blister packs.
Maltese: Pakketti ta' folji ta' l-aluminju/PVC.
English: Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Maltese: Reykjavikurvegur 76-78 220
English: With continued longterm treatment, 11.4 % of the patients were seizure-free for at least 6 months and 7.2 % were seizurefree for at least 1 year.
Maltese: Bi trattament li jikompla fit-tul, 11.4 % tal-pazjenti ma kellhomx aċċessjonijiet għal mill-inqas 6 xhur u 7.2 % ma kellhomx aċċessjonijiet għal mill-inqas sena.
English: confusion, panic attack, emotional instability/mood swings, agitation;
Maltese: konfużjoni, attakk ta' paniku, instabilta` emozzjonali/tibdil fil-burdati, agitazzjoni;
English: In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Maltese: Huwa wkoll jaqleb parzjalment it-tnaqqis f'kurrenti gated b' GABA u glycine indotti b' żingu u ß-carbolines.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to
Maltese: Reazzjonijiet avversi huma ippreżentati fl-ordni ta' inqas gravi u ilfrekwenza tagħhom ġiet mfissra b'dan il-mod: komuni hafna (≥1/10); komuni: (>1/100 sa ≤1/10);
English: Each film-coated tablet contains 0.156 mg sunset yellow E110.
Maltese: Kull pillola miksija b'rita fiha 0.156 mg sunset yellow E110.
English: The pharmacokinetic results indicated that half-life was shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/min/kg) than for adults (0.96 ml/min/kg).
Maltese: Ir-riżultati farmakokinetiċi wrew li l-half-life kien iqsar (5.3 h) minn dak fl-adulti (7.2 h) u l-clearance li deher kien iżjed mgħaġġel ( 1.5 ml/min/kg) minn dak fl adulti (0.96 ml/min/kg).
English: 750 mg tablet: Indigo carmine (E132), sunset yellow (E110), iron oxide red (E172).
Maltese: pllola 250 mg: Indigo carmine (E132) pillola 500 mg: Iron oxide yellow (E172), indigo carmine (E132). pillola 750 mg: Indigo carmine (E132), sunset yellow (E110), iron oxide red (E172).
English: Levetiracetam Actavis is used:
Maltese: Jekk tinsa tieħu Levetiracetam Actavis:
English: Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Maltese: Daqsijiet ta' pakketti Folji: 20, 30, 50, 60, 100, 120 u 200 pillola miksija b'rita.
English: Perforated unit dose blisters: 60 x 1 film-coated tablets.
Maltese: Folji perforati b'doża waħda: 60 x 1 pillola miksija b' rita.
English: basis) and 1,200 mg/kg/day for fetuses.
Maltese: 1,800 mg/kg/ġurnata.
English: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Maltese: Prodotti mediċinali ta' kontra l-epilessija Tagħrif minn studji kliniċi f'adulti li saru qabel ma ħareġ fis-suq, juri li levetiracetam ma kellu ebda effett fuq il-konċentrazzjonijiet ta' mediċini eżistenti kontra l-epilessija (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin u primidone), u li dawn il-prodotti ma kellhom ebda effett fuq il-profil farmakokinetiku ta' levetiracetam.
English: 220 Hafnarfjörður Iceland
Maltese: Hafnarfjörður Islanda
English: The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Maltese: levitiracetam huwa ġeneralment simili fil-gruppi kollha ta' l-etajjiet (adulti u pażjenti pedjatriċi) u fl indikazzjonijiet approvati ta' epilessija kollha.
English: Levetiracetam Actavis 750 mg film-coated tablets Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Maltese: Levetiracetam Actavis 750 mg pilloli miksija b'rita Folji: 20, 30, 50, 60, 100, 120 u 200 pillola miksija b'rita.
English: 43.6 % of the levetiracetam treated patients and 19.6 % of the patients on placebo were considered as responders.
Maltese: 43.6 % tal-pazjenti trattati b'levetiracetam u 19.6 % tal pazjenti fuq plaċebo kienu kkonsidratai bħala li rrispondew.
English: Dose in adults and adolescents (from 16 years of age):
Maltese: Doża fl-adulti u addoloxxenti (minn 16-il sena):
English: Six-month seizure freedom was achieved in 73.0 % of levetiracetam-treated patients and 72.8 % of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2 %
Maltese: Kien hemm 73.0 % tal-pazjenti li ġew trattati b' levetiracetam u 72.8 % ta' pazjenti li ġew trattati b'carbamazepine-CR li damu sitt xhur mingħajr aċċessjonijiet; id-differenza assoluta aġġustata bejn ittrattamenti kienet ta' 0.2 %(95 % CI:-7.8 8.2).
English: With continued long-term treatment, 47.4 % of the patients were free of tonic-clonic seizures for at least 6 months and 31.5 % were free of tonic-clonic seizures for at least 1 year.
Maltese: B'trattament li jitkompla fit-tul, 47.4 % tal pazjenti ma kellhomx aċċessjonijiet tat-tip tonic-clonic għal mill-inqas 6 xhur u 31.5 % ma kellhomx aċċessjonijiet tat-tip tonic-clonic għal mill-inqas sena.
English: Titanium dioxide (E171) Indigo carmine (E132)
Maltese: Indigo carmine (E132)
English: In paediatric patients (4 to 16 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 198 patients and had a treatment duration of 14 weeks.
Maltese: F'pazjenti pedjatriċi (4 sa 16 il-sena), l-effiċjenza ta' levetiracetam kiem muri f' studju double-blind ikkontrollat minn plaċebo li inkluda 198 pazjent b'trattament li dam 14 il-ġimgħa.
English: The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day for the foetuses (equal to the MRHD on a mg/m2 basis).
Maltese: In- NOAEL kien ta' <200 mg/kg/ġurnata fl-ommijiet u 200 mg/kg/ġurnata għal-feti (ugwali għal MRHD fuq bażi ta' mg/m2).
English: Levetiracetam Actavis 1,000 mg tablets Levetiracetam
Maltese: Levetiracetam Actavis 1,000 mg pilloli Levetiracetam
English: The dialyser extraction efficiency is 60% for levetiracetam and 74% for the primary metabolite.
Maltese: L-effiċjenza ta' l-estrazzjoni tad-dijaliżi hija ta' 60% għal levetiracetam u ta' 74% għall-prodott ewlieni tal-metaboliżmu.
English: Levetiracetam Actavis 750 mg tablets contain Sunset Yellow (E110)
Maltese: Levetiracetam Actavis 750 mg pilloli fihom Sunset Yellow FCF (E110).
English: A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six month and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 month to less than 4 years old, was used in this study.
Maltese: Doża ta' 20 mg/kg/ġurnata sa 40 mg/kg/ġurnata għal trabi ta' xahar sa inqas minn sitt xhur u doża ta' 25 mg/kg/ġurnata sa 50 mg/kg/ġurnata għal trabi u tfal minn 6 xhur sa inqas minn 4snin t'eta`, kienu wżati f'dan l-istudju.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (3) (5)
Maltese: 10 sa 20 mg/kg (0.10 sa 0.20 ml/kg) darba kuljum (3) (5)
English: • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Maltese: • waħdu f' adulti u addoloxxenti minn 16 il-sena b'epilessija li għadha kif ġiet iddijanjostikata, fit trattament ta' ċertu forma ta' epilessija.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: .1 Proprejatijiet farmakodinamiċi
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents, children and infants, using the following formula (Schwartz formula):
Maltese: Il-CLcr f' ml/min/1.73 m2 tista' tiġi kkalkulata mill-livell ta' krejatinina fis-serum (mg/dl), għal addoloxenti żgħar, tfal u trabi, billi tuża din il-formula (formula Schwartz):
English: Following single oral dose administration (20 mg/kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
Maltese: Wara li ngħatat doża orali waħda li tammonta għal 20 mg/kg lil tfal bl-epilessija (6 sa 12 -il sena), ilhalf life ta' levetiracetam kienet 6.0 sigħat.
English: Other unidentified components accounted only for 0.6 % of the dose.
Maltese: Komponenti oħrajn li ma ġewx identifikati jagħmlu biss 0.6 % mid-doża kollha.
English: Ks= 0.45 in Term infants to 1 year old; ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male.
Maltese: Ks= 0.45 f'Trabi li twieldu fiż-żmien sa eta` ta' sena; ks= 0.55 fi tfal sa inqas minn 13-il sena u fl addoloxxenti feminili; ks= 0.7 f' addoloxxenti maskili.
English: Rhabdomyolysis and blood creatine phosphokinase increased*
Maltese: Żieda fil rabdomijolisi u l- kreatina fiddemm, phosphokinase*
English: • If you suffer from kidney problems, follow your doctor's instructions.
Maltese: • Jekk int tbati minn problemi fil-kliewi, oqgħod fuq li jgħidlek it-tabib.
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 120 film-coated tablets 200 film-coated tablets 60 x 1 film-coated tablets
Maltese: 20 pilloli miksija b'rita 30 pilloli miksija b'rita 50 pilloli miksija b'rita 60 pilloli miksija b'rita 100 pilloli miksija b'rita 120 pilloli miksija b'rita 200 pilloli miksija b'rita 60 x 1 pilloli miksija b'rita
English: Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening).
Maltese: L-effikaċja ta' levetiracetam kienet stabbilita f'studju double-blind, ikkontrollat minn plaċebo ta' 24 ġimgħa, li inkludiet adulti, addoloxxenti u numru limitat ta' tfal b' epilessija tat-tip ġeneralizzata idjopatika b'aċċessjonijiet ġeneralizzati primarji tat-tip tonic-clonic (PGTC) f'sindromi (epilessija mijoklonika li tibda fiż-żgħożija, epilessija tat-tip absence li tibda fiż-żgħożija, epilessija tat-tip absence fit-tfal, jew epilessija b'aċċessjonijiet Grand Mal meta jqumu).
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Maltese: Is-sustanza attiva, levetiracetam hija derivattiva ta' pyrrolidone (S-enantiomer ta' α-ethyl-2-oxo-1
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
Maltese: Dożaġġ f'adulti u addoloxxenti (12 sa 17 -il sena) li jiżnu 50 kg jew iżjed:
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist).
Maltese: Riżultati li għandhom x'jaqsmu mal-funzjoni tal-imġieba u dik emozjonali juru aggravament fil-pazjenti trattati b' levetiracetam f'imġieba aggressive kif imkejjel b'mod standardizzat u sistematiku bl-użu ta' strument validat (CBCL - Achenbach Child Behavior Checklist).
English: • cough;
Maltese: sogħla;
English: The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness.
Maltese: L-effetti sekondarji rapportati l-aktar frekwentement huma nasofarinġite, sonnolenza (ngħas), uġigħ ta' ras, għeja u sturdament.
English: 7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily
Maltese: 7 sa 21 mg/kg (0.07 sa 0.21 ml/kg) darbtejn kuljum
English: • elevated/abnormal values in a liver function test;
Maltese: valuri elevati/anormali f'test tal-funzjoni tal-fwied abnormali;
English: Peak concentrations (Cmax) are typically 31 and 43 μg/ml following a single 1,000 mg dose and repeated 1,000 mg twice daily dose, respectively.
Maltese: Il-livelli massimi (Cmax) huma s-soltu 31μg/ml wara doża waħda ta' 1,000 mg u 43 μg/ml wara doża ripetuta ta' 1,000 mg darbtejn kuljum.
English: Levetiracetam Actavis 250 mg film-coated tablets Oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side.
Maltese: Levetiracetam Actavis 250 mg pilloli miksija b'rita huma ovali, blu ċar, 13.6 x 6.4 mm imnaqqxa b' “L” fuq naħa u “250” fuq naħa oħra.
English: 35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged < 6 months.
Maltese: 35 trabi b'età inqas minn sena b'aċċessjonijiet parzjali tal-bidu ġew esposti fi studji kliniċi kkontrollati bi plaċebo li minnhom 13 biss kienu ta' bejn <6 xhur.
English: 58.3 % of the levetiracetam treated patients and 23.3 % of the patients on placebo had at least a 50 % reduction in myoclonic seizure days per week.
Maltese: 58.3 % tal-pazjenti trattati b' levetiracetam u 23.3 % tal-pazjenti fuq plaċebo kellhom mill-inqas 50 % ta' tnaqqis fil-ġranet b'aċċessjonijiet mijokloniċi fil-ġimgħa.
English: Add-on therapy for infants aged from 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Maltese: Terapija miżjuda fit-trabi minn eta` ta' 6 sa 23 xahar, tfal (2 sa 11-il sena) u addoloxxenti (12 sa 17-il sena) li jiżnu inqas minn 50 kg
English: In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2%), agitation (common, 3.4%), mood swings (common, 2.1%), affect lability (common, 1.7%), aggression (common, 8.2%), abnormal behaviour (common, 5.6%), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile.
Maltese: 8.2%), mġieba abnormali (komuni, 5.6%), u telqa (komuni, 3.9%) kienu rappurtati iżjed frekwentament minn gruppi ta' etajjiet oħra jew mill-profil ta' sigurta` totali.
English: • delirium;
Maltese: delirju;
English: (3) A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: (3) Doża kbira ta' 15 mg/kg (0.15ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: The NOAEL (No Observed Adverse Effect Level) was 3,600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2
Maltese: In-NAOEL (Livell ta'Ebda Effett Avvers Osservat) kien ta' 3,600 mg/kg/ġurnata għal firien feminili tqal ( x12 il-MRHD
English: The fractional removal of levetiracetam was 51 % during a typical 4-hour dialysis session.
Maltese: It-tneħħija frazzjonali kienet ta'51 % ta' levetiracetam waqt sezzjoni tad-dijaliżi tipika li damet 4 sigħat.
English: Perforated unit dose blisters: 60 x 1 film-coated tablets (only available for 250 mg, 500 mg and 1,000 mg tablets).
Maltese: Folji perforati b' doża waħda: 60 x 1 pillola miksija b' rita (disponibbli biss għal pilloli ta' 250 mg,
English: Sunset Yellow (E110) colouring agent may cause allergic reactions.
Maltese: Sunset Yellow FCF (E110) sustanza li tgħati l-kulur tista' tikkawża reazzjonijiet allerġiċi.
English: 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) twice daily
Maltese: 3.5 sa 7 mg/kg (0.035 sa 0.07 ml/kg) darbtejn kuljum
English: Creatinine clearance (ml/min/1.73 m2)
Maltese: Rata ta' tneħħija tal-krejatinina (ml/min/1.73 m2)
English: Talk to your doctor before taking Levetiracetam Actavis
Maltese: Mediċini oħra u Levetiracetam Actavis
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-żewġt analiżi tal-farmakokinetika fil-popolazzjoni, kien hemm żieda ta' madwar 20 % filclearance li tidher ta' levetiracetam meta ngħatat flimkien mal-prodott mediċinali ta' kontra l epilessija li jindotta l-enżimi.
English: 44.6 % of the levetiracetam treated patients and 19.6 % of the patients on placebo had a 50 % or greater reduction from baseline in the partial onset seizure frequency per week.
Maltese: 44.6 % ta' pazjenti fuq levetiracetam u 19.6 % ta' pazjenti fuq il-plaċebo kellhom tnaqqis ta' 50 % jew iżjed mill-linja bażi fil-frekwenza fil-ġimgħa ta' aċċessjonijiet tat-tip parzjali.
English: 10 to 30 mg/kg (0.10 to 0.30 ml/kg) twice daily
Maltese: 10 sa 30 mg/kg (0.10 sa 0.30ml/kg) darbtejn kuljum
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more The initial therapeutic dose is 500 mg twice daily.
Maltese: Terapija miżjuda għal adulti (≥18 sena ) u addoloxxenti (12 sa 17 il-sena) li jiżnu iżjed minn 50 kg jew iżjed.
English: • 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: • aċċessjonijiet primarji u ġeneralizzati tat-tip tonic-clonic (aċċessjonijiet kbar, inkluż it-telf tas sensi) f' adulti u addoloxxenti 12 il-sena b'epilessija idjopatika ġeneralizzata (it-tip ta
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 wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1.
English: The requirements for submission of periodic safety update report 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: • Rapport Perjodiku ta' Aġġornament dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: • vertigo (sensation of rotation);
Maltese: vertigo (sensazzjoni li kollox idur bik);
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: Twaqqif Jekk levetiracetam għandu jitwaqqaf huwa rakkomandat li jiġi irtirat gradwalment (e.ż. f'adulti u addoloxxenti li jiżnu iżjed minn 50 kg: tnaqqis ta' 500 mg darbtejn kuljum kull ġimagħtejn sa erba' ġimgħat; fi trabi akbar minn 6 xhur, tfal u addoloxxenti li jiżnu inqas minn 50 kg: tnaqqis fid-doża m'għandux jaqbeż 10 mg/kg darbtejn kuljum kull ġimagħtejn; fit-trabi (ta' inqas minn 6 xhur): tnaqqis fid-doża m'għandux jaqbeż 7 mg/kg darbtejn kuljum kull ġimagħtejn).
English: Levetiracetam Actavis 750 mg tablets Levetiracetam
Maltese: Levetiracetam Actavis 750 mg pilloli Levetiracetam
English: Tablet containers: 30, 100 and 200 film-coated tablets.
Maltese: Kontenituri: 30, 100 u 200 pillola miksija b'rita.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) twice daily
Maltese: 10 sa 20 mg/kg (0.10 sa 0.20 ml/kg) darbtejn kuljum kuljum
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1,800 mg/kg/day (x 6 - 17 the MRHD on a mg/m2 basis).
Maltese: Studji fl-annimali tat-twelid u ġovanili fil-firien u l-klieb wrew li ma kienx hemm effetti avversi fil punti tat-tmiem standard tal-iżvillup jew maturazzjoni b'dożi sa 1,800 mg/kg/ġurnata ( x6 - 17 ilMRHD fuq bażi ta' mg/m2).
English: Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms.
Maltese: L-iżoformi taċ-ċitokromju P450 fil fwied ma jgħinux il-produzzjoni ta' ucb L057, li huwa l-prodott ewlieni tal-metaboliżmu.
English: Two embryo-foetal development (EFD) studies were performed in rats at 400, 1,200 and 3,600 mg/kg/day.
Maltese: Żewġt studji fuq l-iżvillup ta' l-embriju u l-fetu (EFD) saru fil-far b'400, 1,200 u 3,600 mg/kg/ġurnata.
English: Levetiracetam Actavis 250 mg tablets Levetiracetam
Maltese: Levetiracetam Actavis 250 mg pilloli Levetiracetam
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
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis)
Maltese: (DRESS), ipersensitivita` (li tinkludi anġjoedima u anafillassi)
English: Levetiracetam Actavis 500 mg tablets Levetiracetam
Maltese: Levetiracetam Actavis 500 mg pilloli Levetiracetam
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily
Maltese: 7 sa 14 mg/kg (0.07 sa 0.14 ml/kg) darbtejn
English: • muscle weakness, myalgia (muscle pain);
Maltese: telf ta' xagħar, ekżema, ħakk; debolezza fil-muskoli, mijalġja (uġigħ fil-muskoli);
English: EU/1/11/713/018 30 tablets EU/1/11/713/019 100 tablets EU/1/11/713/020 200 tablets
Maltese: EU/1/11/713/018 30 pilloli EU/1/11/713/019 100 pilloli EU/1/11/713/020 200 pilloli
English: The dose level of 1,800 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' 1,800 mg/kg/ġurnata indotta tossiċita` materna sostanzjali u tnaqqis fil-piz tal-fetu assoċjat ma' tnaqqis fl-inċidenza ta' feti b'abnormalitajiet kardjovaskolari/skeltrali.
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 120 film-coated tablets 200 film-coated tablets
Maltese: 20 pilloli miksija b'rita 30 pilloli miksija b'rita 50 pilloli miksija b'rita 60 pilloli miksija b'rita 100 pilloli miksija b'rita 120 pilloli miksija b'rita 200 pilloli miksija b'rita
English: The elimination half-life was approximately 5 hours.
Maltese: trattament ta' 5 tijiem.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilmediċini http://www.ema.europa.eu
English: Levetiracetam Actavis 750 mg contains colouring agent sunset yellow (E110) which may cause allergic reactions.
Maltese: Levetiracetam Actavis 750 mg fih sustanza li tagħti l-kulur sunset yellow (E110) li tikkawża reazzjonijiet allerġiċi.
English: Levetiracetam Actavis 500 mg tablets are oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side.
Maltese: Levetiracetam Actavis 500 mg pilloli miksija b'rita huma ovali, sofor, 17.1 x 8.1 mm imnaqqxa b' “L”
English: • liver failure, hepatitis;
Maltese: insuffiċjenza tal-fwied, epatite;
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine (E132)
Maltese: Iron oxide yellow (E172)
English: Suicide
Maltese: Attentat ta'
English: How to store Levetiracetam Actavis Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra