FrancophonIA/ELRC3.0 huggingface dataset:
English: CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73
Maltese: CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73 BSA pazjent (m2)
English: The elimination half-life was approximately 5 hours.
Maltese: Il-half-life ta' eliminazzjoni kien bejn wieħed u ieħor 5 siegħat.
English: Oral contraceptives and other pharmacokinetics interactions
Maltese: Kontraċettivi orali u interazzjonijiet farmakokinetiċi oħra
English: Contains E216, E218, maltitol liquid (E965) and propylene glycol (E1520).
Maltese: Fih E216, E218, maltitol likwidu (E965) u propylene glycol (E1520).
English: Specifar ABEE Τηλ: +30 210 5401500
Maltese: Τηλ: +30 210 5401500
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% (95 % CI: -7.8 8.2).
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 it-trattamenti kienet ta' 0.2%(95% CI:-7.8 8.2).
English: Moderate
Maltese: Moderata
English: Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritability
Maltese: Depressjoni, ostilita`/ aggressjoni, anzjeta`, insomnja, nervożita`/irritabilta`
English: CLcr (ml/min/1.73 m2) = -----------------------------------Serum Creatinine (mg/dl)
Maltese: CLcr (ml/min/1.73 m2) = -----------------------------------Kreatinina fis-serum (mg/dl)
English: Maltitol liquid (E965) Acesulfame potassium (E950) Grape flavour (contains propylene glycol) Purified water
Maltese: Maltitol liquid (E965) Acesulfame potassium (E950) Essenza ta' l-għeneb (fih propylene glycol) Ilma ppurifikat
English: • muscle weakness, myalgia (muscle pain);
Maltese: • debolezza fil-muskoli, mijalġja (uġigħ fil-muskoli);
English: 72.2% of the levetiracetam treated patients and 45.2% of the patients on placebo had a 50% or greater decrease in the frequency of PGTC seizures per week.
Maltese: 72.2% ta' pazjenti fuq levetiracetam u 45.2% tal-pazjenti fuq plaċebo kellhom tnaqqis ta' 50% jew aktar fil-frekwenza ta' aċċessjonijiet PGTC fil-ġimgħa.
English: The metabolite ucb L057 is pharmacologically inactive.
Maltese: Ucb L057 mhuwiex attiv farmakoloġikament.
English: More than half of the subjects remained seizure free for 12 months (56.6% and 58.5% of subjects on levetiracetam and on carbamazepine CR respectively).
Maltese: Iżjed minn nofs il-pazjenti baqaw mingħajr aċċessjonijet għal 12 -il xahar (56.6% u 58.5% tal-pazjenti fuq levetiracetam u fuq carbamazepine CR rispettivament).
English: Each ml contains 1.50 mg of methyl parahydroxybenzoate (E218), 0.15 mg of propyl parahydroxybenzoate (E216), 290 mg of maltitol liquid (E965), 3,26 mg propylene glycol (E 1520) and 0.25 mg of sodium.
Maltese: Kull ml fih 1.50 mg ta' methyl parahydroxybenzoate (E218), 0.15 mg ta' propyl parahydroxybenzoate (E216), 290 mg ta' maltitol likwidu (E965), 3,26 mg propylene glycol (E 1520) u 0.25 mg ta' sodju.
English: Choreoathetosis,
Maltese: Madanakollu,
English: Adults and adolescents
Maltese: Adulti u addoloxxenti Assorbiment
English: Levetiracetam Actavis Group 100 mg/ml oral solution contains 3,26 mg propylene glycol (E1520) in each ml.
Maltese: Levetiracetam Actavis Group 100 mg/ml soluzzjoni orali fih 3,26 mg propylene glycol (E1520) f'kull ml.
English: The active substance is called levetiracetam.
Maltese: Is-sustanza attiva hi levetiracetam.
English: Children (4 to 12 years)
Maltese: Tfal (4 sa 12 -il sena)
English: • elevated/abnormal values in a liver function test;
Maltese: • valuri elevati/anormali fi test tal-funzjoni tal-fwied;
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 rrappreżentati fil-severità tagħhom u tagħhom frekwenza giet mfissra b'dan il-mod: komuni hafna (≥1/10); komuni: (>1/100 sa ≤1/10); mhux komuni: (>1/1,000 sa ≤1/100); rari:
English: Each ml contains 100 mg levetiracetam.
Maltese: Kull ml fih 100 mg levetiracetam.
English: 100 mg/ml oral solution.
Maltese: Group 100 mg/ml soluzzjoni orali.
English: The apparent body clearance was 1.1 ml/min/kg.
Maltese: Il-clearance fil-ġisem deher li kien 1.1 ml/min/kg.
English: From 50 kg (2)
Maltese: Minn 50 kg (2)
English: Levetiracetam 1,000 mg daily did not influence the pharmacokinetics of oral contraceptives (ethinylestradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified.
Maltese: Levitiracetam 1,000 mg kuljum ma kellux effett fuq il-farmakokinetika ta' kontraċettivi orali (ethinylestradiol u levonorgestrel); il-parametri endokrinali (luteinizing hormone u progesterone) ma kienux mibdulin.
English: <1/100); rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000).
Maltese: (≥1/10,000 sa ≤1/1,000); rari ħafna: (≤1/10,000),
English: Frequency category
Maltese: Frekwenza tal-kategorija
English: In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 and UGT1A6) and epoxide hydroxylase activities.
Maltese: In vitro, kemm levetiracetam u kemm il-prodott ewlieni tal-metabolożmu ma fixklux l-iżoformi taċ-ċitokromju P450 fil-fwied ( CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 u 1A2), glucuronyl transferase
English: • delirium;
Maltese: • delirju;
English: Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified.
Maltese: Levitiracetam 2,000 mg kuljum ma kellux effett fuq il-farmakokinetika ta' digoxin u warfarin; il-prothrombin times ma kienux mibdulin.
English: • depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
Maltese: • depressjoni, ostilita` jew aggressjoni, anzjeta`, insomnja, nervożita` jew irritabilta`;
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jista' jaffettwa sa 1 f'1,000 persuna
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Aġenzija Ewropeja għall-Mediċini http://www.ema.europa.eu
English: Thrombocytopenia, leukopenia
Maltese: Trombositopinja, lukopinja
English: Peak plasma concentration was observed 0.5 to 1.0 hour after dosing.
Maltese: Il-konċentrazzjoni massima fil-plażma kienu osservati 0.5 sa 1.0 siegħa wara d-doża.
English: In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Maltese: Barra minn hekk, 101 tarbija b'età inqas minn 12-il xahar ġew esposti fi studju tas-sikurezza wara l awtorizzazzjoni.
English: • encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
Maltese: • enċefalopatija (ara sottosezzjoni “Għid lit-tabib tiegħek immedjatament” għal deskrizzjoni dettaljata tas-sintomi);
English: A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures.
Maltese: Studju ta' sigurta' fil-pedjatrija, ikkontrollat mill-plaċebo u double-blind b'disinn non-inferiority kejjel l-effetti kognittivi u newropsikoloġiċi ta' levetiracetam f'tfal ta' 4 sa 16-il sena t'eta` b' aċċessjonijiet tat-tip partial onset.
English: Four embryo-foetal development studies were performed in rabbits covering doses of 200, 600, 800, 1,200 and 1,800 mg/kg/day.
Maltese: Erba' studji dwar l-iżvillup tal-embriju u l-fetu saru fil-fniek li koprew dożi ta' 200, 600, 800, 1,200 u 1,800 mg/kg/ġurnata.
English: Date of first authorisation: 5 December 2011 Date of latest renewal: 08 August 2016
Maltese: Data tal-aħħar tiġdied: 8 ta' Awwissu 2016
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 kwalunkwe wieћed mill-eċċipjenti elenkati f'sezzjoni 6.1.
English: • infection;
Maltese: • nażofaringite;
English: A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1,800 mg/kg/day.
Maltese: Studju fuq l-iżvillup li sar waqt u wara t-tqala sar fil-firien b'dożi ta' levetiracetam ta' 70, 350 u 1,800 mg/kg/ġurnata.
English: In a pooled analysis, the percentage of patients who achieved 50% or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7%, 31.6% and 41.3% for patients on 1,000, 2,000 or 3,000 mg levetiracetam respectively and of 12.6% for patients on placebo.
Maltese: F'analiżi miġbur, il-perċentaġġ ta' pazjenti li laħqu tnaqqis ta' 50% jew iżjed mill-linja bażi fil-frekwenza fil-ġimgħa ta' aċċessjonijiet tat-tip parzjali b'doża stabli (12/14 ġimgħa), kien ta' 27.7%, 31.6% u 41.3% għal pazjenti fuq 1,000, 2,000, jew 3,000 mg ta'
English: Results related to behavioral 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: levetiracetam f'imġieba aggressive kif imkejjel b'mod standardizzat u sistematiku bl-użu ta' strument validat (CBCL - Achenbach Child Behavior Checklist).
English: Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) Levetiracetam Actavis Group 100 mg/ml oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Maltese: Methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216) Levetiracetam Actavis Group100mg/ml soluzzjoni orali fih methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216) li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jieħdu iżżmien biex jidhru).
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: 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: In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more frequently than in other age groups or in the overall safety profile.
Maltese: F'trabi u tfal t'eta` minn xahar sa inqas minn 4 snin, irritabilta` (komuni ħafna, 11.7%) u ko-ordinazzjoni abnormali (komuni, 3.3%) kienu rappurtati iżjed frekwentament minn fil-gruppi t'etajjiet oħra jew mill-profil ta' sigurta` totali.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14
Maltese: Kategorija farmakoterapewtika: mediċini għall-kontra l-epilessija, mediċini għall-kontra l-epilessija oħra, Kodiċi ATC:
English: In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1,000 mg, 2,000 mg, or 3,000 mg/day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
Maltese: F'adulti, l-effiċjenza ta' levetiracetam kien muri fi 3 studji double-blind ikkontrollati minn plaċebo f'dożi ta' 1,000 mg, 2,000 mg, jew 3,000 mg/ kuljum, mogħtija f' 2 dożi separati, b'trattament li dam sa 18 il- ġimgħa.
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 f'addoloxxenti feminili; ks= 0.7 f' addoloxenti maskili.
English: In patients aged 1 month to less than 4 years, a total of 190 patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
Maltese: F'pazjenti minn eta` ta' xahar sa inqas minn 4 snin, total ta' 190 pazjent kienu ttrattati b' levetiracetam f'studji ta' estenzjoni open label u kkontrollati bil-plaċebo.
English: With continued long-term treatment, 8.6% of the patients were seizure-free for at least 6 months and 7.8 % were seizure-free for at least 1 year.
Maltese: B'trattament kontinwu fit-tul, 8.6% tal-pazjenti kienu mingħajr aċċessjonijiet għal mill-inqas 6 xhur u 7.8% kienu mingħajr aċċessjonijiet għal mill-inqas sena.
English: The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerin, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour (contains propylene glycol), purified water.
Maltese: propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerin, glycerol (E422), maltitol likwidu (E965), acesulfame potassium (E950), essenza ta' l-għeneb (fih propylene glycol), ilma purifikat.
English: • liver failure, hepatitis;
Maltese: • insuffiċjenza tal-fwied, epatite;
English: Your doctor will establish the best possible treatment of overdose.
Maltese: It-tabib tiegħek ser jiddeċiedi l-aħjar trattament possibli għat-trattament tal-overdose.
English: With continued long-term treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for at least 1 year.
Maltese: Bi trattament li jitkompla 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: 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: Fit-tfal u addoloxxenti t'eta` ta' 4-16-il sena, ir-rimettar (komuni ħafna, 11.2%), aġitazzjoni (komuni, 3.4%), tibdil fil-burdati (komuni, 2.1%), tibdil spiss ta' emozzjonijiet (komuni, 1.7%), aggressjoni (komuni, 8.2%), mġieba abnormali (komuni, 5.6%),
English: As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam.
Maltese: Bħal fl-adulti, m'hemm ebda evidenza klinikament sinifikanti ta' effetti ta' mediċini oħra f' pazjenti pedjatriċi li jieħdu sa 60 mg/kg/ġurnata ta' levetiracetam.
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 kien muri f' studju double-blind ikkontrollat minn plaċebo li inkluda 198 pazjent b'trattament li dam 14 il-ġimgħa.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (3) (5)
Maltese: 10 to 20 mg/kg (0.10 sa 0.20 ml/kg) darba kuljum (3) (5)
English: Alopecia, eczema, pruritus,
Maltese: Alopacja, ekzema,
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% 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: Levetiracetam Actavis Group 100 mg/ml oral solution Levetiracetam
Maltese: Levetiracetam Actavis Group 100 mg/ml soluzzjoni orali Levetiracetam
English: Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Maltese: Terapija miżjuda għal adulti (≥18 sena ) u addoloxxenti (12 sa 17 il-sena) li jiżnu iżjed minn 50 kg jew iżjed.
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: (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: Muscular weakness, myalgia
Maltese: Debbulezza muskolari, mijalġja
English: It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Maltese: Kien konkluż li levetiracetam ma kienx differenti (mhux inferjuri) mill-plaċebo fejn jidħol il-bidla mill-linja bażi tal- Leiter-R Attention and Memory, Memory Screen Composite score fil-popolazzjoni skond il-protokol.
English: With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0% were free of myoclonic seizures for at least 1 year.
Maltese: B'trattament li jitkompla fit-tul, 28.6% tal-pazjenti ma kellhomx aċċessjonjiet mijokloniċi għal mill-inqas 6 xhur u 21.0% ma kellhomx aċċessjonjiet mijokloniċi għal mill-inqas sena.
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: 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' α-ethyl-2-oxo-1
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: • rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase.
Maltese: • rabdomajoliżi (tkissir ta' tessut tal-muskoli) u żieda assoċjata mal-krejatina phosphokinase fiddemm.
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: Elderly (65 years and older)
Maltese: Anzjani (65 sena u fuqhom)
English: (2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Maltese: (2) Wara id-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 250 u 500 mg.
English: Infection
Maltese: Infezzjoni
English: Hepatic failure, hepatitis
Maltese: Insuffiċjenza epatika, epatite
English: A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six months and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 months to less than 4 years old, was use 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: 300 ml oral solution with a 10 ml oral syringe.
Maltese: 300 ml Soluzzjoni orali b' siringa ta' 10 ml.
English: Nervous system Somnolence,
Maltese: Disturbi fis sistema nervuża
English: Dose in adults and adolescents from 16 years of age:
Maltese: Doża fl-adulti u addoloxxenti minn 16-il sena:
English: • vertigo (sensation of rotation);
Maltese: • vertigo (sensazzjoni li kollox idur bik);
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: Pancytopenia, neutropenia, agranulocytosis
Maltese: Diplopja, viżjoni mċajpra
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: 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: 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 trabija b'età inqas minn sena b'aċċessjonijiet parzjali tal-bidu ġew esposti fl-istudji kliniċi kkontrollati bi plaċebo li minnhom 13 biss kienu ta' bejn <6 xhur.
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 għandhu jitwaqqaf huwa rakkomandat li tirtirah gradwalment (e.ż. f'adulti u addoloxxenti li jiżnu iżjed minn 50 kg: tnaqqis ta' 500 mg darbtejn kuljum kull ħmistax 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 ħmistax; fi trabi (ta' inqas minn 6 xhur): tnaqqis fid-doża m'għandiex taqbeż 7 mg/kg darbtejn kuljum kull ħmistax).
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), il-half life ta' levetiracetam kienet 6.0 sigħat.
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination using, for young adolescents, children and infants, using the following formula (Schwartz formula):
Maltese: Il-CLcr f' ml/min/1.73 m2 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: Use the 10 ml syringe included in the package.
Maltese: Uża s-siringa ta' 10 ml inkluża fil-pakkett.
English: Use the 3 ml oral syringe and adaptor included in the package
Maltese: Uża is-siringa orali ta' 3 ml u adattur inklużi fil-pakkett
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: 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 taddati 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: • abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
Maltese: • uġigħ fl-addomenu, dijareja, dispepsja (indigistjoni), rimettar, dardir;
English: Rare disorders headache disorder, dizziness, lethargy, tremor impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention dyskinesia, hyperkinesia, gait disturbance, encephalopathy
Maltese: Amneżija, impediment talmemorja, koordinazzjoni abnormali/ataxja, paraestesija, disturbi fl' attenzjoni
English: General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1,500 mg).
Maltese: kull doża individwali għandu jitkejjel bejn 5 ml (500 mg) u 15 ml (1,500 mg).