FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains 57.21 mg sodium per maximum single dose, equivalent to 2.86 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Din il-prodott mediċinali fih 57.21 mg sodium f'doża singola massima, ekwivalenti għal 2.86 % talammont massimu rakkomandat mill-WHO ta 2 g sodium li għandu jittieħed kuljum minn adult.
English: Date of first authorisation: 03 October 2011 Date of latest renewal: 29 June 2016
Maltese: DATA TAL -EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 03 Ottubru 2011
English: One tablet of Matever 1000 mg contains 1000 mg of levetiracetam.
Maltese: Pillola waħda ta' Matever 1000 mg fih 1000 mg levetiracetam.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galattożju, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: • rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase.
Maltese: • rabdomilożi (it-tkissir tat-tessut tal-muskoli) u żieda assoċjata fil-creatinine phosphokinase fiddemm.
English: Matever 1000 mg tablets contain lactose
Maltese: Matever 1000 mg pilloli fih lactose
English: Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Maltese: Stevens-Johnson), u forma iżjed severa li tikkawża ġilda li titqaxxar f'iżjed minn 30% tal-wiċċ tal-ġilda (nekroliżi tossiku epidermali);
English: • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Maltese: • Fit-trattament ta' aċċessjonijiet primarji u ġeneralizzati tat-tip tonic-clonic f'adulti u addoloxxenti minn 12 il-sena b'Epilessija Ġeneralizzata Idjopatika.
English: Matever 250 mg film-coated tablets Matever 500 mg film-coated tablets Matever 750 mg film-coated tablets Matever 1000 mg film-coated tablets levetiracetam
Maltese: Matever 250 mg pilloli miksija b'rita Matever 500 mg pilloli miksija b'rita Matever 750 mg pilloli miksija b'rita Matever 1000 mg pilloli miksija b'rita levetiracetam
English: Alopecia, eczema, pruritus,
Maltese: Alopacja, ekzema, ħakk,
English: Matever 100 mg/ml concentrate for solution for infusion levetiracetam
Maltese: Matever 100 mg/ml konċentrat għal soluzzjoni għall-infużjoni levetiracetam
English: Each ml contains 100 mg of levetiracetam.
Maltese: Kull ml fih 100 mg levetiracetam.
English: Peak plasma concentration (Cmax) observed in 17 subjects following a single intravenous dose of 1500 mg infused over 15 minutes was 51 ± 19 µg/ml (arithmetic average ± standard deviation).
Maltese: L-ogħla konċentrazzjoni fil-plażma (C max) osservati f' 17 il-pazjent wara doża waħda ta' 1500 mg li ittieħded b'infużjoni minn ġol-vina f' 15 il-minuta kienet ta' 51 ± 19 µg/ml (il-medja aritmatika ± standard deviation).
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: 4 % talpazjenti 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: 500 mg tablet: quinoline yellow aluminium lake (E104) 750 mg tablet: indigo carmine aluminum lake (E132), sunset yellow FCF aluminum lake (E110) 1000 mg tablet: (no additional colourant).
Maltese: *Is-sustanzi li jagħtu l-kulur huma: pllola 250 mg: indigo carmine aluminium lake (E132), , sunset yellow FCF aluminium lake (E110), quinoline yellow aluminium lake (E104) pllola 500 mg: quinoline yellow aluminium lake (E104), pllola 750 mg: indigo carmine aluminium lake (E132), sunset yellow FCF aluminium lake (E110) pillola 1000 mg: (no additional colourant).
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 ta' 6.0 sigħat.
English: Matever is used:
Maltese: Matever huwa wżat:
English: One tablet of Matever 750 mg contains 750 mg of levetiracetam.
Maltese: Pillola waħda ta' Matever 750 mg fih 750 mg levetiracetam.
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 ta' inqas minn sena b' aċċessjonijiet partial onset kienu esposti f studji kliniċi kkontrollati minn plaċebo li minnhom 13 biss kienu iżgħar minn 6 xhur.
English: Matever 250 mg film-coated tablets Matever 500 mg film-coated tablets Matever 750 mg film-coated tablets Matever 1000 mg film-coated tablets
Maltese: Matever 250 mg pilloli miksija b'rita Matever 500 mg pilloli miksija b'rita Matever 750 mg pilloli miksija b'rita Matever 1000 mg pilloli miksija b'rita
English: One tablet of Matever 250 mg contains 250 mg of levetiracetam.
Maltese: Pillola waħda ta' Matever 250 mg fih 250 mg levetiracetam.
English: After dilution the infusion is stable for 24 hours at 2 °C - 8 °C (in a refrigerator).
Maltese: Wara li jiġi dilwit is-soluzzjoni għall-infużjoni hija stabbli għal 24 siegħa f' 2 °C - 8 °C (fi friġġ).
English: Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg: General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Maltese: Dożaġġ fit-tfal (4 sa 11 il-sena) u addoloxxenti (12 sa 17 il-sena) li jiżnu inqas minn 50 kg Doża normali: bejn 20 mg kull kg kg tal-piz tal-ġisem u 60 mg kull kg tal-piz tal-ġisem kuljum.
English: The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50 % reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Maltese: Il-kejl primarju ta' effettivita` kienet ir-rata ta' pazjenti li rrispondew (persentaġġ tal-pazjenti b' ≥ 50 % tnaqqis mill-linja bażi fil-frekwenza tal-medda ta' aċċessjonijiet tat-tip partial onset f'ġurnata) mkejla b' blinded central reader bl'użu ta' vidjo EEG ta' 48 siegħa.
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: General dose: between 1,000 mg and 3,000 mg each day.
Maltese: Dożaġġ f'adulti u addoloxxenti (12 sa 17 il-sena) li jiżnu 50 kg jew iżjed Doża normali: bejn 1,000 mg u 3,000 mg kuljum.
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: • Biex jiżdied ma' mediċini oħra ta' kontra l-epilessija fit-trattament aċċessjonijiet tat-tip parzjali kemm bil, kif ukoll mingħajr ġeneralizazzjoni f'adulti, addoloxxenti, tfal u trabi minn eta` ta' xahar. aċċessjonijiet tat-tip mijokloniċi (skossi qosra, bħal xokk f muskolu jew grupp ta' muskoli) f' adulti u addoloxxenti minn 12 snin b'epilessija tat-tip mijoklonika li tibda fiż-żgħożija aċċessjonijiet primarji u ġeneralizzati tat-tip tonic-clonic (aċċessjonijiet maġġuri, inkluż telf ta' koxjenza) f'adulti u addoloxxenti 12 il-sena b'epilessija idjopatika.ġeneralizzata (it-tip ta' epilessija li hi maħsuba li għandha kawża ġenetika).
English: Matever concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15-25 °C.
Maltese: Il-konċentrat Matever instab li kien fiżikament kompattibli u kimikament stabli meta mħallat ma' dawn id-dilwenti għal mill-inqas 24 siegħa u meta maħżun f' basktijiet tal-PVC f'temperatura ta' lambjent kontrollata ta' 15-25°C.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behavior as measured in a standardized and systematic way using a validated instrument (CBCL - Achenbach Child Behavior 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: EU/1/11/711/001 EU/1/11/711/002 EU/1/11/711/003 EU/1/11/711/004 EU/1/11/711/005 EU/1/11/711/006
Maltese: EU/1/11/711/001 EU/1/11/711/002 EU/1/11/711/003 EU/1/11/711/004
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 f' Tfal sa inqas minn 13-il sena u fl'addoloxxenti feminili; ks= 0.7 f' addoloxxenti maskili
English: • uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
Maltese: • spażmi fil-muskoli inkontrollablili jaffetwaw ir-ras, it-torso u d-dirgħajn u r-riġlejn, diffikulta` biex tikkontrolla l-movimenti, iperkineżja (iperattivita`);
English: A risk of birth defects for your unborn child cannot be completely excluded.
Maltese: Riskju li jista' jkun hemm difetti għat-tarbija ġol-guf mhux ma jistax jiġi kompletament eskluż.
English: PHARMACEUTICALPARTICULARS
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Suicide attempt, suicidal ideation,psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, panic attack, affect lability/mood swings, agitation
Maltese: Attenta ta' suwiċidju, ħsibijiet ta' suwiċidju,mard psikotiċi, mġieba abnormali, alluċinazzjonijiet, rabja, stat konfużjonali, , attakk ta' paniku, tibdil flemozzjonijiet/tibdil fil-burdati, agitazzjoni
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 f-epilessija).
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: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, panic attack, affect lability/mood swings, agitation
Maltese: Attenta ta' suwiċidju, ħsibijiet ta' suwiċidju,mard psikotiċi, mġieba abnormali, alluċinazzjonijiet, rabja, stat konfużjonali, attakk ta' paniku, tibdil flemozzjonijiet/tibdil fil-burdati, agitazzjoni
English: Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Maltese: Wara id-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 250 u 500 mg.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Maltese: • raxx fil-ġilda, li jista' jifforma bżieżaq u li jidher qisu targi żgħar (tikek ċentrali skuri mdawwra b'erja iżjed pallida, b'ċirku skur mat-tarf) (erythema multiforme), raxx diffuz bil-bżieżaq u ġilda li titqaxxar, partikolarrment madwar il-ħalq, mnieħer, għajnejn u l-ġenitali (sindrome ta' Stevens-Johnson), u forma iżjed severa li tikkawża ġilda li titqaxxar f'iżjed minn 30% tal-wiċċ tal-ġilda (nekroliżi tossiku epidermali);
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: Intwera korrelazzjoni sinifikanti bejn il-konċentrazzjonijiet fil-bżieq u fil-plażma fl-adulti u fit-tfal ( 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: Contains glacial acetic acid, water for injections, sodium acetate trihydrate, sodium chloride - see leaflet for further information.
Maltese: Fih glacial acetic acid, ilma għall-injezzjonijiet, sodium acetate trihydrate, sodium chloride.
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: In- NOAEL kien ta' <200 mg/kg/ġurnata fl-ommijiet u 200 mg/kg/ġurnata għal-feti (ugwali għal MRHD fuq bażi ta' mg/m
English: Each film-coated tablet contains 0.08 mg sunset yellow FCF aluminum lake (E110).
Maltese: Kull pillola miksija b'rita fiha 0.08 mg sunset yellow FCF aluminium lake (E110).
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: Jekk levetiracetam għandu jitwaqqaf hu rrikkmandat li jitwaqqaf gradwalment (ez. 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 jiżnu 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: The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections.
Maltese: Sustanzi oħra jinkludu: sodium acetate trihydrate, glacial acetic acid, sodium chloride, ilma għallinjezzjoni
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 ssoltu 31g/ml wara doża waħda ta' 1,000 mg u 43 g/ml wara doża ripetuta ta' 1,000 mg darbtejn kuljum.
English: quinoline yellow aluminium lake (E104)
Maltese: Propylene glycol (E1520) Quinoline Yellow Aluminium lake (E104)
English: Pallini Attiki
Maltese: Sustanzi mhux attivi
English: EU/1/11/711/015 EU/1/11/711/016 EU/1/11/711/017 EU/1/11/711/018 EU/1/11/711/019 EU/1/11/711/020
Maltese: EU/1/11/711/016 EU/1/11/711/017 EU/1/11/711/018 EU/1/11/711/019 EU/1/11/711/020
English: This is equivalent to 2.86 % of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 2.86 % tal-ammont massimu rakkomandat ta' sodium li ghandu jittieħed kuljum mad-dieta minn adult.
English: Nasopharyngit is
Maltese: TA' EĊĊIPJENTI
English: Film-coating: hypromellose (E464), titanium dioxide (E171), talc, propylene glycol (E1520) colourants*.
Maltese: Il-kisja tar-rita: hypromellose (E464), titanium dioxide (E171), talc, propylene glycol (E1520), , , sustanza li jagħtu l-kulur*.
English: One tablet of Matever 500 mg contains 500 mg of levetiracetam.
Maltese: Pillola waħda ta' Matever 500 mg fih 500 mg levetiracetam.
English: Other medicines and Matever
Maltese: Mediċini oħra u Matever
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Maltese: Is-sustanza attiva, levetiracetam hija derivattiva ta' pyrrolidone (S-enantiomer ta' -ethyl-2-oxo-1pyrrolidine acetamide), u ma jixbahx kimikament lil sustanzi attivi oħrajn li jintużaw kontra lepilessija.
English: The CLcr in ml/min/1.73 m 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 m tista' tigi kkalkulata mill-livell ta' krejatinina fis-serum (mg/dl), għal addoloxenti żgħar, tfal u trabi, billi tuża din il-formula (formula Schwartz):
English: Example: if your daily dose is 1,000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Maltese: Jekk id-doża tiegħek hija 1,000 mg kuljum, jista' jkun li trid tieħu 2 pilloli ta' 250 mg filgħodu u 2 pilloli ta' 250 mg filgħaxija.
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) (0.105 ml/kg)darbtejn kuljum
English: Each film-coated tablet contains 0.0025 mg sunset yellow FCF aluminum lake (E110).
Maltese: Kull pillola miksija b'rita fiha 0.0025 mg sunset yellow FCF aluminium lake (E110).
English: See Table 1 for the recommended preparation and administration of Matever concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg in two divided doses.
Maltese: Ara iskeda 1 għall-preparazzjoni rikkmandata kif ukoll il-metodu rikmandat ta' kif jingħata l-konċentrat Matever biex tilħaq doża totali ta' 500 mg, 1000 mg, 2000 mg, jew 3000 mg kuljum, f'żewġt dożi separati.
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 pillola miksija b'rita.
English: • 750 mg: 20, 30, 50, 60, 80, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.
Maltese: • 750 mg: 20, 30, 50, 60, 80, 100, 120 u pakkett b'ħafna ta' 200 (2 pakketti b'100) pillola miksija b'rita.
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
Maltese: 7 sa 14 mg/kg (0.07 sa 0.14 ml/kg) darbtejn kuljum
English: The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in fetal weight associated with increased incidence of fetuses with cardiovascular/skeletal anomalies.
Maltese: Il-livell tad-doża ta' 1800 mg/kg/ġurnata indotta tossiċita` maternal sostanzjali u tnaqqis fil-piz tal-fetu assoċjat ma' tnaqqis fl-inċidenza ta' feti b'abnormalitajiet cardjovaskolari/skeltrali.
English: How to store Matever
Maltese: X'fih Matever
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-addoloxxenti b'epilessija (4 sa 17 ilsena) ikkonferma li terapija miżjuda b' levetitacetam li jittieħed mill-ħalq ma kellux effett fuq konċentrazzjonijiet tas-serum fi stat fiss ta' carbamazepine u valproate li jingħataw fl-istess ħin.
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 lepilessija li jindotta l-enżimi.
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' 25kg għandha tkun 250 mg darbtejn kuljum b'doża massima ta' 750 mg darbtejn kuljum.
English: Propylene glycol (E1520) Indigo carmine aluminum lake (E132) Sunset yellow FCF aluminum lake (E110)
Maltese: Indigo carmine aluminium lake (E132) Sunset yellow FCF aluminium lake (E110) Quinoline Yellow Aluminium lake (E104).
English: Fax: +30 210 66 66 749
Maltese: Tel.: +30 210 66 04 300 Fax: +30 210 66 66 749
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) darba kuljum
English: Matever concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 1525°C.
Maltese: Il-konċentrat Matever instab li kien fiżikament kompattibli u kimikament stabli meta mħallat ma' dawn id-dilwenti għal mill-inqas 24 siegħa u meta maħżuna f' basktijiet tal-PVC f'temperatura ta' lambjent kontrollata ta' 15- 25 °C.
English: Matever 750 mg film-coated tablets
Maltese: Matever 750 mg pilloli miksija b'rita
English: • 500 mg: 10, 20, 30, 50, 60, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.
Maltese: • 500 mg: 10, 20, 30, 50, 60, 100, 120 u pakkett b'ħafna ta' 200 (2 pakketti b'100) pillola miksija b'rita.
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jista' jaffettwa sa 1 f' 1,000 persuni
English: Each ml contains 3.81 mg sodium.
Maltese: Eċċipjent(i) b'effett magħruf Kull ml fih 3.81 mg ta' sodium.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily
Maltese: 10 sa 20 mg/kg (0.10 sa 0.20 ml/kg) darba kuljum
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: 500 to 1,500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily (2)
Maltese: Doża totali ta' kuljum250 mg 2.5 ml (nofs vjala ta' 5 ml) 100 ml 15 minuti Darbtejn kuljum 500 mg/ġurnata 500 mg 5 ml (vjala waħda ta' 5 ml) 100 ml 15 minuti Darbtejn kuljum 1000 mg/ ġurnata 1000 mg 10 ml (żewġt vjali ta' 5 ml) 100 ml 15 minuti Darbtejn kuljum 2000 mg/ ġurnata 1500 mg 15 ml (tlett vjali ta' 5 ml) 100 ml 15 minuti Darbtejn kuljum 3000 mg/ ġurnata
English: Levetiracetam 100mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets don't allow accurate dose.
Maltese: Levetiracetam 100mg / ml soluzzjoni orali hija formulazzjoni aktar xieraq għat-trabi u t-tfal taħt l-età ta ' 6 snin u lit-tfal u l-adolexxenti (minn 6 sa 17-il sena) li jiżnu inqas minn 50 kg u meta lpilloli ma jippermettux dożaġġ preċiż.
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.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: B'trattament kontinwu fit-tul, 8.6 % tal-pazjenti kienu mingħajr aċċessjonijiet għal mill-inqas 6 xhur u 7.8 % kienu mingħajr aċċessjonijiet għal mill-inqas sena.
English: Epilepsy is a condition where the patients have repeated fits (seizures).
Maltese: L-epilessija hija kondizzjoni fejn il-pazjent ikollu aċċessjonijiet ripetuti.
English: 80 film-coated tablets
Maltese: 80 pillola miksija b'rita
English: 250 mg tablet: indigo carmine aluminum lake (E132), sunset yellow FCF aluminum lake (E110),
Maltese: Indigo carmine aluminium lake (E132) Sunset yellow FCF aluminium lake (E110) Iron oxide red (E172)
English: • convulsion, balance disorder (equilibrium disorder),dizziness (sensation of unsteadiness),
Maltese: • aċċessjonijiet, mard tal-bilanċ (mard tal-ekwilibru), sturdament (sensazzjoni ta' ċaqliq),