FrancophonIA/ELRC3.0 huggingface dataset:
English: Levetiracetam ratiopharm 1000 mg film-coated tablets EU/1/11/702/025
Maltese: Levetiracetam ratiopharm 1000 mg pilloli miksija b'rita EU/1/11/702/025
English: reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Maltese: ≥ 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: • suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger,
Maltese: • attentat ta' suwiċidju u ħsibijiet ta' suwiċidju, mġieba abnormali, alluċinazzjonijiet, rabja,
English: EU/1/11/702/004 EU/1/11/702/005 EU/1/11/702/006 EU/1/11/702/007 EU/1/11/702/008
Maltese: EU/1/11/702/005 EU/1/11/702/006 EU/1/11/702/007 EU/1/11/702/008
English: One film-coated tablet of Levetiracetam ratiopharm 1000 mg contains 1000 mg levetiracetam.
Maltese: Pillola miksija b'rita ta' Levetiracetam ratiopharm 1000 mg fiha 1000 mg levetiracetam.
English: Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1200 and 1800 mg/kg/day.
Maltese: Erba' studji dwar l-iżvilupp tal-embriju u l-fetusaru fil-fniek li koprew dożi ta' 200, 600, 800, 1200 u 1800 mg/kg/ġurnata.
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 adoloxxenti minn 12-il sena b'Epilessija Mijoklonika Ġovanili.
English: Levetiracetam
Maltese: OĦRAJN
English: Quincke's oedema [swelling of the face, lips, tongue and throat]);
Maltese: Quinke [nefħa fil-wiċċ, xofftejn u griżmejn]);
English: 49 mg (0.5 ml)twice daily 147 mg (1.5 ml) twice daily
Maltese: 147 mg (1.5 ml) darbtejn kuljum
English: Film-coated tablet Multipack: 200 (2 packs of 100) film-coated tablets
Maltese: Pillola miksija b'rita Multipack: 200 (2 pakketti ta' 100) pillola miksija b'rita
English: EU/1/11/702/025 EU/1/11/702/026 EU/1/11/702/027 EU/1/11/702/028 EU/1/11/702/029 EU/1/11/702/030
Maltese: EU/1/11/702/026 EU/1/11/702/027 EU/1/11/702/028 EU/1/11/702/029 EU/1/11/702/030
English: Contains methyl and propyl parahydroxybenzoate and potassium.
Maltese: Fih methyl u propyl parahydroxybenzoate u potassium
English: Choreoathetosis, dyskinesia, hyperkinesia, gait abnormal/ataxia, paraesthesia, disturbance in attention disturbance, encephalopathy
Maltese: sistema nervuża ta' ras bilanċ, sturdament, telqa, rogħda impediment talmemorja, koordinazzjoni abnormali/ataxja, paraestesija, disturbi fl' attenzjoni diskinesija, iperkinesja, diffikultà filmixi,
English: The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Maltese: Il-profil ta' sigurta` ta' levetiracetam huwa ġeneralment simili fil-gruppi kollha ta' l-etajjiet (adulti u pażjenti pedjatriċi) u fl-indikazzjonijiet approvati ta' epilessija kollha.
English: One film-coated tablet of Levetiracetam ratiopharm 750 mg contains 750 mg levetiracetam.
Maltese: Pillola miksija b'rita ta' Levetiracetam ratiopharm 750 mg fiha 750 mg levetiracetam.
English: Tablet core:
Maltese: Doża massima:
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 ma jistax jiġi kompletament eskluż.
English: One film-coated tablet of Levetiracetam ratiopharm 250 mg contains 250 mg levetiracetam.
Maltese: Pillola miksija b'rita ta' Levetiracetam ratiopharm 250 mg fiha 250 mg levetiracetam.
English: Levetiracetam ratiopharm 750 mg film-coated tablets Levetiracetam
Maltese: Levetiracetam ratiopharm 750 mg pilloli levetiracetam
English: Levetiracetam ratiopharm oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Maltese: Is-soluzzjoni orali ta' Levetiracetam ratiopharm tinkludi methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216) li jistgħu jikkawżaw reazzjonijiet allerġiċi (possibilment wara ftit żmien).
English: Levetiracetam ratiopharm 100 mg/ml oral solution
Maltese: Levetiracetam ratiopharm 100 mg/ml soluzzjoni orali
English: General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).
Maltese: Levetiracetam ratiopharm jittieħed darbtejn kuljum, f'żewġ dożi maqsumin indaqs, kull doża individwali titkejjel bejn 5 ml (500 mg) u 15-il ml (1500 mg).
English: Levetiracetam ratiopharm 1000 mg film-coated tablets Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Titanium dioxide (E171)
Maltese: Levetiracetam ratiopharm 1000 mg pilloli miksija b'rita Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Titanium dioxide (E171)
English: Each ml oral solution contains 100 mg levetiracetam.
Maltese: Kull ml ta' soluzzjoni orali fiha 100 mg levetiracetam.
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
Maltese: Doża fl-adulti u fl-adolexxenti (12 sa 17-il sena) li jiżnu 50 kg jew aktar:
English: Levetiracetam ratiopharm 250 mg film-coated tablets Levetiracetam
Maltese: Levetiracetam ratiopharm 250 mg pilloli levetiracetam
English: For children aged 1 month to less than 6 months.
Maltese: Għal tfal ta' età minn xahar sa inqas minn 6 xhur.
English: Rare: may affect up to 1 in 1000 people
Maltese: Rari: jista' jaffettwa sa 1 f'1,000 persuna
English: Levetiracetam ratiopharm 500 mg film-coated tablets Levetiracetam
Maltese: Levetiracetam ratiopharm 500 mg pilloli levetiracetam
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: Maximum dose: 21 mg/kg twice daily
Maltese: 21 mg/kg darbtejn kuljum
English: How to take Levetiracetam ratiopharm
Maltese: Tiħux Levetiracetam ratiopharm
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 tal-awrina baxx, għajja, dardir, rimettar, konfużjoni u nefħa fir-riġlejn, għekiesi jew fis-saqajn, għax dan jista' jkun sinjal ta' tnaqqis f'daqqa fil-funzjoni tal-kliewi
English: One film-coated tablet of Levetiracetam ratiopharm 500 mg contains 500 mg levetiracetam.
Maltese: Pillola miksija b'rita ta' Levetiracetam ratiopharm 500 mg fiha 500 mg levetiracetam.
English: EU/1/11/702/010 EU/1/11/702/011 EU/1/11/702/012 EU/1/11/702/013 EU/1/11/702/014 EU/1/11/702/015
Maltese: EU/1/11/702/011 EU/1/11/702/012 EU/1/11/702/013 EU/1/11/702/014
English: Infants should start the treatment with Levetiracetam ratiopharm 100 mg/ml oral solution.
Maltese: Fil-każijiet kollha t'hawn fuq għandha tingħata soluzzjoni orali ta' 100 mg/ml ta' Levetiracetam ratiopharm.
English: Starting dose: 0.1 ml/kg twice daily
Maltese: 0.1 ml/kg darbtejn kuljum
English: Levetiracetam ratiopharm 750 mg film-coated tablets Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Anatase titanium dioxide (E171), Yellow Iron Oxide (E172), Red Iron Oxide (E172)
Maltese: Levetiracetam ratiopharm 750 mg pilloli miksija b'rita Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Anatase Titanium dioxide (E171), Yellow Iron Oxide (E172), Red Iron Oxide (E172)
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 ijiem.
English: General dose: Levetiracetam ratiopharm 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: Levetiracetam ratiopharm jittieħed darbtejn kuljum, f'żewġ dożi maqsumin indaqs, kull doża individwali li titkejjel bejn 0.07 ml (7 mg) u 0.21 (21 mg), għal kull kg ta' piż tal-ġisem tat tarbija.
English: 150 ml brown 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: Flixkun kannella tal-ħġieġ ta' 150 ml (tip III) b'għatu reżistenti għall-ftuħ mit-tfal (polypropylene) f'kaxxa tal-kartun li fiha siringa orali gradata ta' 3 ml (polypropylene, polyethylene( u b'adapter għas siringa (polyethylene).
English: Use the 3 ml syringe included in the package.
Maltese: Uża s-siringa ta' 3 ml inkluża fil-pakkett.
English: 7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily
Maltese: 7 sa 21 mg/kg darbtejn kuljum
English: • Remove the filled syringe from the bottle (figure ).
Maltese: • Neħħi s-siringa minn mal-flixkun (figura ).
English: 150 mg (1.5 ml) twice daily 450 mg (4.5 ml)twice daily
Maltese: 150 mg darbtejn kuljum 450 mg darbtejn kuljum20 kg (1)
English: Maximum dose: 30 mg/kg twice daily
Maltese: 30 mg/kg darbtejn kuljum
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: Other medicines and Levetiracetam ratiopharm
Maltese: Mediċini oħra u Levetiracetam ratiopharm
English: 0.8 ml twice daily
Maltese: 0.8 ml darbtejn kuljum 2.4 ml darbtejn kuljum
English: Levetiracetam ratiopharm 500 mg film-coated tablets Packs containing 10, 20, 30, 50, 60 or 100 film-coated tablets or multipacks containing 120 (2 packs of 60) or 200 (2 packs of 100) film-coated tablets.
Maltese: Levetiracetam ratiopharm 500 mg pilloli miksija b'rita Il-pakketti fihom 10, 20, 30, 50, 60 jew 100 pillola miksija b'rita u multipacks li fihom 120 (2 pakki ta' 60) jew 200 (2 pakki ta' 100) pillola miksija b'rita.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for bottles - 300 ml (10 ml syringe)
Maltese: Kartun għall-fliexken - 300 ml (siringa ta' 10 ml)
English: 750 mg twice daily
Maltese: 250 mg darbtejn kuljum 750 mg darbtejn kuljum
English: 60 mg (0.6 ml) twice daily 180 mg (1.8 ml) twice daily
Maltese: 60 mg darbtejn kuljum 180 mg darbtejn kuljum
English: The 150 ml glass bottle of Levetiracetam ratiopharm oral solution (for infants aged 6 months and above and children aged 2 to 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.
Maltese: Il-flixkun tal-ħġieġ għal soluzzjoni orali ta' Levetiraceptam ratiopharm ta' 150 ml (għat-trabi u tfal minn 6 xhur u aktar u tfal bejn is-sentejn u l-4 snin) jinsab f'kaxxa tal-kartun li fiha siringa orali gradata ta' 3 ml (gradata kull 0.1 ml) u b'adapter għas-siringa.
English: Levetiracetam ratiopharm 750 mg film-coated tablets Packs containing 20, 30, 50, 60, 80 or 100 film-coated tablets or multipacks containing 200 (2 packs of 100) film-coated tablets.
Maltese: Levetiracetam ratiopharm 750 mg pilloli miksija b'rita Il-pakketti fihom 20, 30, 50, 60, 80 jew 100 pillola miksija b'rita u multipacks li fihom 200 (2 pakki ta' 100) pillola miksija b'rita.
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2 basis) and 1200 mg/kg/day for fetuses.
Maltese: The NAOEL (Livell ta'Ebda Effett Avvers Osservat) kien ta' 3600 mg/kg/ġurnata għal firien feminili tqal ( x12 il-MRHD
English: Ísland ratiopharm Oy, Finnland
Maltese: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland
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' skadenza li tidher fuq il-kaxxa u l-folja, wara EXP.
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 80 film-coated tablets 100 film-coated tablets
Maltese: 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 60 pillola miksija b'rita 80 pillola miksija b'rita 100 pillola miksija b'rita
English: Instructions for use:
Maltese: Doża ġenerali:
English: Dosing adjustment for adult and adolescents 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: Starting dose: 7 mg/kg twice daily
Maltese: 7 mg/kg darbtejn kuljum
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) twice daily
Maltese: 10 sa 20 mg/kg darbtejn kuljum
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: • 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 (elenkati fis-sezzjoni 6).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for bottles - 150 ml (3 ml syringe)
Maltese: Kartun għall-fliexken - 150 ml (siringa ta' 3 ml)
English: Use the 1 ml syringe included in the package.
Maltese: Uża s-siringa ta' 1 ml inkluża fil-pakkett.
English: 300 ml brown 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) and an adaptor for the syringe (polyethylene).
Maltese: f'kaxxa tal-kartun li fiha siringa orali gradata ta' 10 ml (polypropylene, polyethylene( u b'adapter għas-siringa (polyethylene).
English: • convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
Maltese: • aċċessjonijiet, mard tal-bilanċ (mard tal-ekwilibru), sturdament (sensazzjoni ta' ċaqliq), telqa,
English: General dose: Levetiracetam ratiopharm 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: Levetiracetam ratiopharm jittieħed darbtejn kuljum, f'żewġ dożi maqsumin indaqs, kull doża individwali titkejjel bejn 0.1 ml (10 mg) u 0.3 ml (30 mg), għal kull kg ta' piż tal-ġisem tattifel/tifla (ara t-tabella hawn taħt għal eżempji tad-doża).
English: Monotherapy
Maltese: enċefalopatija
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
Maltese: 7 sa 14 mg/kg darbtejn kuljum
English: Rhabdomyolysis and blood creatine phosphokinase increased*
Maltese: Rabdomijolożi u żieda fil creatinine phosphokinase fid-demm*
English: Levetiracetam ratiopharm 1000 mg film-coated tablets Packs containing 10, 20, 30, 50, 60 or 100 film-coated tablets or multipacks containing 200 (2 packs of 100) film-coated tablets.
Maltese: Levetiracetam ratiopharm 1000 mg pilloli miksija b'rita Il-pakketti fihom 10, 20, 30, 50, 60 jew 100 pillola miksija b'rita u multipacks li fihom 200 (2 pakki ta' 100) pillola miksija b'rita.
English: For children 6 years and above, Levetiracetam ratiopharm 100 mg/ml oral solution should be used for doses under 125 mg, for doses not multiple of 125 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Maltese: 125 mg, għal dożi mhux multipli ta' 125 mg meta r-rikomandazzjoni tad-dożaġġ ma jistax jintlaħaq billi jittieħdu pilloli multipli u għal pazjenti li mhumiex kapaċi jibilgħu l-pilloli
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for bottles - 150 ml (1 ml syringe)
Maltese: Kartun għall-fliexken - 150 ml (siringa ta' 1 ml)
English: Excipients
Maltese: Iponatrimja
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: 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: EU/1/11/702/018 EU/1/11/702/019 EU/1/11/702/020 EU/1/11/702/021 EU/1/11/702/022 EU/1/11/702/023
Maltese: EU/1/11/702/021 EU/1/11/702/022 EU/1/11/702/023
English: Maximum dose: 0.3 ml/kg twice daily
Maltese: 0.3 ml/kg darbtejn kuljum
English: • Levetiracetam ratiopharm is used as a chronic treatment.
Maltese: • Levetiracetam ratiopharm huwa użat bħala trattament għal marda kronika.
English: Add-on therapy for infants aged from 1 month to less than 6 months
Maltese: Terapija miżjuda fi trabi minn età ta' xahar sa inqas minn 6 xhur
English: In several cases of alopecia, recovery was observed when levetiracetam was discontinued.
Maltese: alopeċja, kien osservat irkupru meta twaqqaf levetiracetam.
English: 10 to 30 mg/kg (0.10 to 0.30 ml/kg) twice daily
Maltese: 10 sa 30 mg/kg darbtejn kuljum
English: Starting dose: 10 mg/kg twice daily
Maltese: 10 mg/kg darbtejn kuljum
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: Jekk id-doża tiegħek hija 1,000 mg kuljum, tista' tieħu 2 pilloli ta' 250 mg filgħodu u 2
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 skont l-età.
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: muskoli) f'adulti u addoloxxenti minn 12-il sena 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 ta' 12-il sena b'epilessija idjopatika.ġeneralizzata
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - 300 ml (10 ml syringe)
Maltese: Tikketta tal-fliexken - 300 ml (siringa ta' 10 ml)
English: Clear liquid.
Maltese: Mhux applikabbli.
English: This leaflet was last revised in {month/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {XX/SSSS}
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 inizjali ta' 15 mg/kg hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Maltese: 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 60 pillola miksija b'rita 100 pillola miksija b'rita
English: 7.5 ml twice daily
Maltese: 2.5 ml darbtejn kuljum 7.5 ml darbtejn kuljum
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer wrapper label on multipacks wrapped in transparent foil - including the Blue Box
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Tikketta tat-tgeżwir ta' barra għal multipacks f'fojl trasparenti li jinkludi l-Kaxxa Blu
English: 1-6 months
Maltese: 1-6 xhur
English: Package Leaflet: Information for the patient
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Multipack Carton for blister packs- without the Blue Box
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa ta' Multipack għal pakketti ta' folji mingħajr il-Kaxxa Blu
English: Levetiracetam ratiopharm 1000 mg film-coated tablets Levetiracetam
Maltese: Levetiracetam ratiopharm 1,000 mg soluzzjoni orali levetiracetam
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: The possible side effects of an overdose of Levetiracetam ratiopharm 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: 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 talfetumarbut ma' żieda marġinali f'varjazzjonijiet skeletali/ anormalitajiet minuri.
English: Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
Maltese: Għalhekk huwa rrikkmandat li meta r-rata li biha titneħħa l-kreatinina tkun < 60 ml/min/1.73 m2, għandu jkun hemm tnaqqis ta' 50 % tad-doża ta' kuljum.
English: If stopping treatment, Levetiracetam ratiopharm should be discontinued gradually to avoid an increase of seizures.
Maltese: Jekk tkun ser twaqqaf it-trattament, għandek tnaqqas Levetiracetam ratiopharm bil-mod biex ma jkunx hemm żieda fl-aċċessjonijiet.
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Maltese: Ebda reazzjonijiet avversi fuq il-fertilità maskili jew femminili jew abbiltà riproduttiva ma kienu osservati fil-firien f'dożi sa 1800 mg/kg/day (x 6 l-MRHD fuq bażi ta' mg/m2 jew ta' esponiment)
English: The initial therapeutic dose is 7 mg/kg twice daily.
Maltese: Id-doża terapewtika inizjali hi ta' 7 mg/kg darbtejn kuljum.