FrancophonIA/ELRC3.0 huggingface dataset:
English: 43.6% of the levetiracetam treated patients and 19.6% of the patients on placebo were considered as responders.
Maltese: 44.6% ta' pazjenti fuq levetiracetam u 19.6% ta' pazjenti fuq il-plaċebo kellhom tnaqqis ta' 50%
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam).
Maltese: Suwiċidju, attentat ta' suwiċidju, ħsibijiet u mġieba suwiċidali kienu rrappurtati f'pazjenti trattati b'mediċini ta' kontra l-epilessija (inkluż levetiracetam).
English: • a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Maltese: • forma aktar serja ta' raxx li jikkawża ġilda titqaxxar f'aktar minn 30% tal-ġisem (nekrolisi epidermali tossika);
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull ml, jiġifieri essenzjalment ‘ħieles mis-sodium'.
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: Glycerin
Maltese: Anzjani
English: The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Maltese: Il-profil tar-reazzjonijiet avversi ppreżentati hawn taħt huwa bbażat fuq l-analiżi ta' ġabra ta' provi kliniċi kkontrollati bil-plaċebo fejn ġew studjati l-indikazzjonijiet kollha, b'total ta' 3,416 pazjent trattati b'levetiracetam.
English: 300 ml oral solution with a 1 ml oral syringe and an adaptor.
Maltese: 300 ml Soluzzjoni orali b' siringa ta' 1 ml u adattur.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intoleranza għall-fructose m'għandhomx jieħdu din ilmediċina.
English: Excipients with known effect:
Maltese: Eċċipjenti b'effett maghruf:
English: - A 300 ml bottle with a 1 ml oral syringe (delivering up to 100 mg levetiracetam) graduated every 0.05 ml (corresponding to 5 mg).
Maltese: - Flixkun ta' 300 ml b'siringa orali ta' 1 ml (li jwassal sa 100 mg ta' levetiracetam) b'marka tal-kejl kull 0.05 ml (ekwivalenti għal 5 mg).
English: The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Maltese: Ilprofil ta' sigurta` ta' levitiracetam huwa ġeneralment simili fil-gruppi kollha ta' l-etajjiet (adulti u pażjenti pedjatriċi) u fl-indikazzjonijiet approvati ta' epilessija kollha.
English: Actavis Ltd. Tel: +35621693533
Maltese: Tel: +35621693533
English: Levetiracetam Actavis Group 100 mg/ml oral solution
Maltese: Levetiracetam Actavis Group 100 mg/ml soluzzjoni orali
English: • decreased number of all blood cell types;
Maltese: • tnaqqis fin-numru tat-tipi kollha ta' ċelloli tad-demm;
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: The major metabolic pathway (24% of the dose) is an enzymatic hydrolysis of the acetamide group.
Maltese: Il-mod prinċipali kif jiġi metabolizzat (24 % tad-doża) huwa permezz ta' idroliżi tal-grupp aċetamajd.
English: Instruction for use for 1 ml and 3 ml syringes with an adaptor
Maltese: Istruzzjonijiet għall-użu għal 1 ml u 3 ml siringi ma' adattur
English: - A 300 ml bottle with a 3 ml oral syringe (delivering up to 300 mg levetiracetam) graduated every 0.1 ml (corresponding to 10 mg).
Maltese: - Flixkun ta' 300 ml b'siringa orali ta' 3 ml(li jwassal sa 300 mg ta' levetiracetam) b'marka tal-kejl kull 0.1 ml (ekwivalenti għal 10 mg).
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 siegħat wara d-doża b'soluzzjoni orali).
English: 7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily
Maltese: 7 to 21 mg/kg (0.07 sa 10 to 30 mg/kg (0.10 sa 0.21 ml/kg) darbtejn kuljum
English: Add-on therapy for infants aged 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
English: For adults and children aged 4 years and older
Maltese: Għall-adulti tfal ta' eta 4 snin u iktar.
English: Age also had an influence on both parameters.
Maltese: L-eta` kellha wkoll effett fuq iż-żewġt parametri.
English: • nasopharyngitis;
Maltese: • infezzjonijiet;
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: 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: България Актавис ЕАД
Maltese: Актавис ЕАД Teл.:
English: For children aged 6 months to less than 4 years
Maltese: Għal tfal ta' eta minn 6 xhur sa inqas minn 4 snin
English: • suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
Maltese: • suwiċidju, mard tal-personalita` (problemi ta' mġieba), ħsibijiet abnormali (ħsieb bil-mod, ma tistax tikkonċentra);
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: carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin u primidone), u li dawn ilprodotti ma kellhom ebda effett fuq il-profil farmakokinetiku ta' levetiracetam.
English: • decreased blood sodium concentration;
Maltese: • tnaqqis fil-konċentrazzjoni ta' sodium fid-demm;
English: Only limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero.
Maltese: Hemm biss evidenza limitata disponibbli dwar l-iżvilupp newroloġiku tat-tfal esposti għal monoterapija b'levetiracetam fl-utru.
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
Maltese: 7 to 14 mg/kg (0.07 sa 0.14 ml/kg) darba kuljum
English: 1,500 mg twice daily (1) Children 25 kg or less should preferably start the treatment with Levetiracetam Actavis Group
Maltese: (1) Tfal ta' 25 kg jew inqas għandhom preferabilment jibdew it-trattament bi Levetiracetam Actavis
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 (t'eta` ta' xahar sa inqas minn 4 snin), l-effikaċja ta' levetiracetam kienet stabbilita f'studju kkontrollat mill-plaċebo u double-blind li inkludew 116-il pazjent u kellu tul ta' trattament ta' 5 tijiem.
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 basis) and 1,200 mg/kg/day for fetuses.
Maltese: In-NAOEL (Livell ta'Ebda Effett Avvers Osservat) kien ta' 3,600 mg/kg/ġurnata għal firien feminili tqal ( x12 il-MRHD fuq bażi ta' mg/m2) u
English: Use the 10 ml oral syringe included in the package
Maltese: Uża is-siringa orali ta' 10 ml inklużi fil-pakkett
English: In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.
Maltese: Esperimenti li saru in vitro u in vivo jgħatu x'nifhmu li levetiracetam ma jibdilx il-karatteristiċi taċ-ċelloli basiċi u n-newrotrasmissjoni normali.
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
Maltese: suwiċidju, ħsibijiet ta' suwiċidju, mard psikotiċi, mġieba abnormali, alluċinazzjonijiet, rabja, stat konfużjonali ,
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 addoloxxenti minn 12 -il sena b'epilessija ġeneralizzata idjopatika.
English: 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) twice daily
Maltese: 3.5 to 7 mg/kg (0.035 sa 5 to 10 mg/kg (0.05 sa 0.07 ml/kg) darbtejn kuljum
English: • symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function;
Maltese: • sintomi bħal volum baxx tal-awrina, għeja, dardir, rimettar, konfużjoni u nefħa fir-riġlejn, għekiesi jew saqajn, għax dan jista' jkun sinjal ta' tnaqqis f'daqqa tal-funzjoni tal-kliewi;
English: • diplopia (double vision), vision blurred;
Maltese: • diplopja (viżjoni dopplja), viżjoni mċajpra;
English: Use the 1 ml syringe and adaptor included in the package.
Maltese: Uża s-siringa ta' 1 ml u adattur inkluzi fil-pakkett.
English: The NOAEL was <200 mg/kg/day for the dams and 200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m2 basis).
Maltese: 200 mg/kg/ġurnata għal-feti (ugwali għal MRHD fuq bażi ta' mg/m2).
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 (0.15 ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: Levetiracetam Actavis Group is not indicated in children and adolescents below 16 years on its own (monotherapy).
Maltese: Levetiracetam Actavis Group mhux indikat fit-tfal u adoloxxenti ta' taħt 16-il sena waħedha (monoterapija).
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' bidliet mentali serji jew jekk xi ħadd madwarek ra fik sinjali ta' konfużjoni, ngħas (ngħas), amnesija (telf ta' memorja), indeboliment tal-memorja (tinsa), mġieba mhux normali jew sinjali newroloġiċi oħrajn inklużi movimenti mhux ikkontrollatiolontarji jew inv.
English: Add-on therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
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
English: The mechanism of this risk is not known.
Maltese: Il-mekkaniżmu ta' dan ir-riskju mhux magħruf.
English: In this study, levetiracetam dose was 3,000 mg/day for adults and adolescents or 60 mg/kg/day for children, given in 2 divided doses.
Maltese: levetiracetam kienet ta' 3,000 mg/ġurnata fl-adulti u l-addoloxxenti jew 60 mg/kg/ġurnata fit-tfal, li ingħataw f'2 dożi separati.
English: Antiepileptic medicinal products
Maltese: GĦAMLA FARMAĊEWTIKA
English: 300 ml oral solution with a 3 ml oral syringe and an adaptor.
Maltese: 300 ml Soluzzjoni orali b' siringa ta' 3 ml u adattur.
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 fetuses 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: Levetiracetam is not extensively metabolised in humans.
Maltese: Levetiracetam mhux metabolizzat estensivament fil-bniedem.
English: Other medicines and Levetiracetam Actavis Group
Maltese: Mediċini oħra u Levetiracetam Actavis Group
English: Repeat until there are no bubbles in the syringe (Figure 6).
Maltese: Irrepeti sakemm ma jkunx hemm bżieżaq fis-siringa (Figura 6).
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 3 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Maltese: Dan issibu ġo kaxxa tal-kartun li fiha wkoll siringa orali ta' 3 ml mmarkata bilkejl (polypropylene,polyethylene),u adattur għas-siringa (polyethylene).
English: A large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
Maltese: Ammont kbir ta' data ta' wara t-tqegħid fis-suq dwar nisa tqal esposti għal monoterapija b'levetiracetam ('il fuq minn 1800, li fosthom f'iktar minn 1500, l-esponiment seħħ matul l-ewwel trimestru tat-tqala) ma jissuġġerix żieda fir-riskju ta' malformazzjonijiet konġenitali maġġuri.
English: 5 to 15 mg/kg (0.05 to 0.15 ml/kg) twice daily
Maltese: 5 mg/kg (0.035 5 to 15 mg/kg (0.05 sa sa 0.105 ml/kg) darbtejn kuljum
English: Hyponatraemia
Maltese: Monoterapija
English: The 300 ml glass bottle of Levetiracetam Actavis Group (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.
Maltese: Il- flixkun tal-ħġieg ta' 300 ml ta' Levetiracetam Actavis Group (għal trabi ta' xahar sa inqas minn sitt xhur) huwa ppakkjat f'kaxxa tal-kartun li fiha siringa orali ta' 1 ml (b'marka tal-kejl kull 0.05 ml) u adattur għas-siringa.
English: Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults.
Maltese: Ir-riżultati ta' sigurta` f'pazjenti pedjatriċi f'studji kkontrollati bil-plaċebo kienu konsistenti mal-profil ta' sigurta` ta' levetiracetam fl-adulti ħlief għar-reazzjonijiet avversi ta' mġieba u psikjatriċi li kienu iżjed komuni fit-tfal milli fl-adulti.
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 ( x 6 - 17 ilMRHD fuq bażi ta' mg/m2).
English: How to take Levetiracetam Actavis Group
Maltese: Tieħux Levetiracetam Actavis Group
English: Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Maltese: Levetiracetam hija mediċina għal kontra l-epilessija (użata biex tittratta l-aċċessjonijiet fl-epilessija).
English: Dose in adults and adolescents (12 to 17 years):
Maltese: Terapija miżjuda Dożaġġ f'adulti u addoloxxenti (12 sa 17 il-sena):
English: • in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
Maltese: • fit-trattament ta' aċċessjonijiet tat-tip parzjali kemm meta jkun hemm, kif ukoll meta ma jkunx hemm ġeneralizzazzjoni sekondarja f' adulti, addoloxxenti, tfal u trabi minn eta` ta' xahar b'epilessija.
English: However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behavior were not worse than baseline.
Maltese: aggravament, u fil-medda, fil-funzjoni tal-imġieba u emozjonali; f'kejl partikolari ta' imġieba aggressiva, din ma kinitx agħar mill-linja bażi.
English: Levetiracetam Actavis Group 100 mg/ml oral solution contains maltitol liquid.
Maltese: Maltitol likwidu Levetiracetam Actavis Group 100 mg/ml soluzzjoni orali fih wkoll maltitol likwidu.
English: General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of the child. (see table below for dose examples).
Maltese: kull doża individwali għandu jitkejjel bejn 0.1 ml (10 mg) u 0.3 ml (30 mg), ma' kull kg tal-piż tal ġisem tat-tifel jew tifla (ara tabella t'hawn taħt ghal eżempji tad-dożi).
English: The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications.
Maltese: Il-profil ta' reazzjonijiet avversi ta' levitiracetam huwa ġeneralment simili fil-gruppi kollha ta' l etajjiet (adulti u pażjenti pedjatriċi) u fl-indikazzjonijiet approvati ta' epilessija kollha.
English: End-stage renal disease patients undergoing dialysis (1)
Maltese: Rata ta' tneħħija Doża u frekwenza (1)
English: 250 to 750 mg twice daily
Maltese: 250 to 750 mg darbtejn kuljum
English: • uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
Maltese: biex tikkontrolla l-movimenti, iperkineżja (iperattivita`);
English: The mean total body clearance was 0.96 ml/min/kg.
Maltese: hija ta' 4.2 ml/min/kg.
English: 28 mg (0.3 ml) twice daily 84 mg (0.85 ml) twice daily
Maltese: 84 mg (0.85 ml) darbtejn kuljum
English: Mild
Maltese: Tqala
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jista' jaffettwa sa 1 f'100 persuna
English: Following single dose administration (20 mg/kg) of a 100 mg/ml oral solution to epileptic children (1 month to 4 years), levetiracetam was rapidly absorbed and peak plasma concentrations were observed approximately 1 hour after dosing.
Maltese: Wara li ngħatat doża waħda (20 mg/kg) ta' 100 mg/ml soluzzjoni orali lil tfal epilettiċi (xahar sa 4 snin), levetiracetam kien assorbit malajr u l-konċentrazzjonijiet massimi fil-plażma kienu osservati bejn wieħed u ieħor siegħa wara d-doża.
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: General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of the infant.
Maltese: kull doża individwali għandu jitkejjel bejn 0.07 ml (7 mg) u 0.21ml (21 mg), ma' kull kg tal-piż tal ġisem tarbija (ara tabella t'hawn taħt għal eżempji tad-dożi).
English: Nasopharyngitis
Maltese: agranuloċitożi
English: Cough
Maltese: UŻU
English: The 300 ml glass bottle of Levetiracetam Actavis Group (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml).
Maltese: Il- flixkun tal-ħġieg ta' 300 ml ta' Levetiracetam Actavis Group (għal tfal minn eta ta' erba' snin u ‘l fuq, addoloxxenti u adulti) huwa ppakkjat f'kaxxa tal-kartun li fiha siringa orali ta' 10 ml (b'marka talkejl kull 0.25 ml) u adattur għas-siringa.
English: Epilepsy is a condition where the patients have repeated fits (seizures).
Maltese: Epilessija hija kundizzjoni fejn il-pazjenti jkollhom aċċessjonijiet ripetuti (attakki ta' puplesija).
English: Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea
Maltese: Koreoatetożi, diskinesija, iperkinesja, diffikultà filmixi,
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene).
Maltese: Dan issibu ġo kaxxa tal-kartun li fiha wkoll siringa orali ta' 10 ml mmarkata bilkejl (polypropylene,polyethylene).
English: For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
Maltese: Indeboliment tal-kliewi Id-doża li tingħata kuljum tiddependi mill-funzjoni tal-kliewi ta' kull pazjent individwali.
English: In this study, patients were prescribed 20 mg/kg, 25 mg/kg, 40 mg/kg or 50 mg/kg daily dose of oral solution based on their age titration schedule.
Maltese: F'dan l-istudju, il-pazjenti ġew mogħtija dożi ta' kuljum ta' 20 mg/kg, 25 mg/kg, 40 mg/kg jew 50 mg/kg ta' soluzzjoni orali bbażati fuq l-iskeda tat-titrazzjoni skond l eta`.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 3 ml syringe
Maltese: Tiketta tal-flixkun ta' 300ml bis-siringa ta' 3 ml
English: 500 to 1,500 mg twice daily
Maltese: 500 to 1,500 mg darbtejn kuljum
English: As with all antiepileptic medicines, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicines AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Maltese: Għandha tingħata preferenza lil monoterapija kull meta dan huwa possibbli għaliex terapija b'diversi mediċini kontra l-epilessija tista' tkun assoċjata ma' riskju ogħla ta' malformazzjonijiet konġenitali minn monoterapija, skont liema mediċini kontra l epilessija jingħataw flimkien.
English: Monotherapy for adults and adolescents from 16 years of age
Maltese: Monoterapija għal adulti u adoloxxenti minn 16-il sena ‘l fuq.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 1 ml syringe
Maltese: Tiketta tal-flixkun ta' 300ml bis-siringa ta' 1 ml
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 addoloxxenti min 12 -il sena b'epilessija mijoklonika li tibda fiż-żgħożija.
English: • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Maltese: • fit-trattament ta' aċċessjonijiet tat-tip mijokloniċi f'adulti u addoloxxenti minn 12 snin b'epilessija tat-tip Mijoklonika li tibda fiż-żgħożija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 10 ml syringe
Maltese: Tiketta tal-flixkun ta' 300ml bis-siringa ta' 10 ml