FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/00/146/001 20 tablets EU/1/00/146/002 30 tablets EU/1/00/146/003 50 tablets EU/1/00/146/004 60 tablets EU/1/00/146/005 100 tablets EU/1/00/146/029 200 tablets (2 packs of 100) EU/1/00/146/034 100 x 1 tablets
Maltese: EU/1/00/146/001 20 pillola EU/1/00/146/002 30 pillola EU/1/00/146/003 50 pillola EU/1/00/146/004 60 pillola EU/1/00/146/005 100 pillola EU/1/00/146/029 200 pillola (2 pakketti ta' 100)
English: 150 mg (1.5 ml) twice daily 450 mg (4.5 ml) twice daily
Maltese: 150 mg (1.5 ml) darbtejn kuljum 450 mg (4.5 ml) darbtejn kuljum20 kg (1)
English: Keppra 100 mg/ml oral solution Levetiracetam
Maltese: Keppra 100 mg/ml soluzzjoni orali Levetiracetam
English: Serum Creatinine (mg/dl)
Maltese: 72 x livell ta' krejatinina fis-serum (mg/dl)
English: Keppra oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Maltese: Keppra soluzzjoni orali hija l-formulazzjoni preferita għall-użu fit-trabi u tfal taħt is-6 snin.
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 taċċitokromju P450 fil-fwied ( CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1 u 1A2), glucuronyl transferase (UGT1A1 u UGT1A6) u l-attivitajiet ta' l-epoxide hydroxylase . Levetiracetam m'għandu ebda effett ukoll fuq il-glukuronidazzjoni ta' valproic acid in vitro.
English: Keppra 750 mg film-coated tablets are orange, 18 mm oblong, scored and debossed with the code “ucb” and “750” on one side.
Maltese: Keppra 750 mg pilloli miksija b'rita huma orangjo, 18 mm tawwalin, maqtuha minn nofs u mnaqqxa bil-kodiċi “ucb” u “750” fuq naħa waħda.
English: 300 ml oral solution
Maltese: U KONTENUT 300 ml soluzzjoni orali.
English: If discontinuation is considered, please refer to section 4.2.
Maltese: Jekk it-twaqqif jiġi kkunsidrat, jekk jogħġbok irreferi għas-sezzjoni 4.2.
English: How to store Keppra
Maltese: Tieħux Keppra
English: Keppra 1000 mg film-coated tablets are white, 19 mm oblong, scored and debossed with the code “ucb” and“1000” on one side.
Maltese: Keppra 1000 mg pilloli miksija b'rita huma bojod, 19 mm tawwalin, maqtuha minn nofs u mnaqqxa bil-kodiċi “ucb” u “1000” fuq naħa waħda.
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 1000, 2000 or 3000 mg levetiracetam respectively and of 12.6 % for patients on placebo.
Maltese: F'analisi 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 1000, 2000, jew 3000 mg ta' levetiracetam rispettivament u ta' 12.6 % għal pazjenti fuq il-plaċebo.
English: UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Maltese: UCB Pharma SA Chemin du Foriest B-1420
English: Blue, 13mm oblong, scored and debossed with the code “ucb” and “250” on one side.
Maltese: Blu,13mm tawwalija, maqtuha minn nofs u mnaqqxa bil-kodiċi “ucb” u ”250” fuq naħa waħda.
English: Keppra oral solution is the preferred formulation for use in this population.
Maltese: Keppra soluzzjoni orali hija l-formulazzjoni preferita għall-użu f'din il-popolazzjoni.
English: Vial of 5 ml
Maltese: 5 ml darbtejn kuljum
English: Keppra 1000 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Keppra 1000 mg
English: EU/1/00/146/014 EU/1/00/146/015 EU/1/00/146/016 EU/1/00/146/017 EU/1/00/146/018 EU/1/00/146/019 EU/1/00/146/028 EU/1/00/146/036
Maltese: EU/1/00/146/015 EU/1/00/146/016 EU/1/00/146/017 EU/1/00/146/018 EU/1/00/146/019 EU/1/00/146/028 EU/1/00/146/036
English: 0.85 ml twice daily
Maltese: 0.85 ml darbtejn kuljum
English: Depression, hostility/ aggression, anxiety, insomnia, nervousness/ irritability
Maltese: Depressjoni, ostilita`/ aggressjoni, anzjeta`, insomnja, nervożita`/irritabilta`
English: • Separate the adaptor from the syringe (figure 2).
Maltese: • Issepara l-edepter mis-siringa (figura 2).
English: Keppra concentrate for solution for infusion was found to be physically compatible and chemically stable for at least 24 hours when mixed with the following diluents and stored in PVC bags at controlled room temperature 15-25 °C.
Maltese: Il-konċentrat Keppra 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' l-ambjent kontrollata ta' 15-25°C.
English: Each ml contains 100 mg levetiracetam.
Maltese: U KWANTITATTIVA Kull ml fiha 100 mg levetiracetam.
English: White, 19 mm oblong, scored and debossed with the code “ucb” and “1000” on one side.
Maltese: Bajda, 19 mm tawwalija, maqtuha minn nofs u mnaqqxa bil-kodiċi “ucb” u ”1000” fuq naħa waħda.
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: Keppra contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol Keppra oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Maltese: Keppra fih parahydroxybenzoate, propylparahydroxybenzoate u maltitol Keppra soluzzjoni orali fih parahydroxybenzoate (E218) u propylparahydroxybenzoate (E216) li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jista' jkun jieħdu iż-żmien biex jidhru).
English: Lot 14.
Maltese: N03AX14.
English: Keppra 750 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Keppra 750 mg
English: One maximum single dose of Keppra concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial).
Maltese: Doża singola massima waħda ta' Keppra fiha 2.5 mmol (jew 57 mg) ta' sodju (0.8 mmol (jew 19 mg) ta' sodju f'kull vjala).
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 addoloxxenti feminil; ks= 0.7 f' addoloxenti maskili
English: 0.8 ml twice daily
Maltese: 0.8 ml darbtejn kuljum2.4
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins ( 10 %).
Maltese: La levetiracetam u lanqas il-prodott ewlieni tal-metaboliżmu ma jeħlu wisq mal-proteini tal-plażma (<10 %).
English: Maximum dose: 21 mg/kg twice daily
Maltese: Doża massima: 21 mg/kg darbtejn kuljum
English: • severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
Maltese: • reazzjonijiet allerġiċi serji (DRESS, reazzjoni anafillattika [reazzjoni severa u importanti],
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of -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: Choreoathetosis, dyskinesia, hyperkinesia, gait disturbance, encephalopathy
Maltese: Koreoatetożi, diskinesija, iperkinesja, diffikultà fil-mixi, enċefalopatija
English: Other medicines and Keppra
Maltese: Mediċini oħra u Keppra
English: UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium or
Maltese: SA, Chemin du Foriest, B-1420
English: • Lactated Ringer's solution for injection
Maltese: • soluzzjoni għall-injezzjoni ta' Lactated Ringer
English: Keppra 250 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Keppra 250 mg
English: One tablet of Keppra 250 mg contains 250 mg of levetiracetam.
Maltese: Pillola waħda ta' Keppra 250 mg fih 250 mg levetiracetam.
English: anger, confusion, panic attack, emotional instability/mood swings, agitation;
Maltese: konfużjoni, attakk ta' paniku, instabilta` emozzjonali/tibdil fil-burdati, agitazzjoni;
English: - A 150 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' 150 ml b'siringa orali ta' 1 ml (li tagħti sa 100 mg ta' levetiracetam) b'marka tal-kejl kull 0.05 ml (ekwivalenti għal 5 mg).
English: Keppra is used:
Maltese: Keppra huwa wżat:
English: EU/1/00/146/018 80 tablets
Maltese: EU/1/00/146/018 80 pillola
English: Only limited evidence is available on the neurodevelopment of children exposed to Keppra monotherapy in utero.
Maltese: Hemm biss evidenza limitata disponibbli dwar l-iżvilupp newroloġiku tat-tfal esposti għal monoterapija b'Keppra fl-utru.
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' prodotti mediċinali ta' kontra l-epilessija (inkluż levetiracetam).
English: UCB Pharma SA Allée de la Recherche 60 B-1070 Brussels Belgium
Maltese: UCB Pharma SA Allée de la Recherche 60
English: Keppra 500 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Keppra 500 mg
English: EU/1/00/146/015 30 tablets
Maltese: EU/1/00/146/015 30 pillola
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, jista' jkun li trid tieħu 2 pilloli ta' 250 mg filgħodu u 2 pilloli ta' 250 mg filgħaxija.
English: EU/1/00/146/019 100 tablets
Maltese: EU/1/00/146/019 100 pillola
English: All other packs are available in standard aluminium/PVC blisters.
Maltese: Ilpakketti l-oħra issibhom f'folji standard tal-aluminju/PVC.
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
Maltese: L-effikaċja ta' levetiracetam kienet stabbilita f'studju double-blind, ikkontrollat minn plaċebo ta' 24 ġimgħa, li inkludiet adulti, addoloxxenti u numru limitat ta' tfal b' epilessija tat-tip ġeneralizzata idjopatika b'aċċessjonijiet ġeneralizzati primarji tat-tip tonic-clonic (PGTC) f'sindromi ( epilessija mijoklonika li tibda fiż-żgħożija, epilessija tat-tip absence li tibda fiż-żgħożija, epilessija tat-tip absence fit-tfal, jew epilessija b'aċċessjonijiet Grand Mal meta jqumu).
English: EU/1/00/146/022 30 tablets
Maltese: EU/1/00/146/022 30 pillola
English: EU/1/00/146/017 60 tablets
Maltese: EU/1/00/146/017 60 pillola
English: The 100 x 1 tablet packs are available in aluminium/PVC perforated unit dose blisters.
Maltese: Il-pakkett tal-pilloli 100 x 1 issibu f'folji tal-aluminju/PVC li jistgħu jinqasmu f'dożi singoli.
English: EU/1/00/146/024 60 tablets
Maltese: EU/1/00/146/024 60 pillola
English: One vial contains 500 mg/5 ml levetiracetam.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Vjala waħda fiha 500 mg /5 ml levitiracetam.
English: EU/1/00/146/025 100 tablets
Maltese: EU/1/00/146/025 100 pillola
English: General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant.
Maltese: Keppra jittieħed darbtejn kuljum, f'żewġt dożi maqsuma indaqs, kull doża individwali mkejla bejn 0.07 ml (7 mg) u 0.21 ml (21 mg), kull kg ta' piz tal-ġisem tat-tarbija (ara t-tabella li jmiss għal eżempji fid-dożi).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljat fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti tal-RMP.
English: - A 150 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' 150 ml b'siringa orali ta' 3 ml(li tagħti sa 300 mg ta' levetiracetam) b'marka tal-kejl kull 0.1 ml (ekwivalenti għal 10 mg).
English: In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and carbolines.
Maltese: Huwa wkoll jaqleb parzjalment it-tnaqqis f'kurrenti gated b' GABA u glycine indotti b' żingu u ß-carbolines.
English: Multipack: 200 (2 packs of 100) film-coated tablets
Maltese: Pakkett multiplu:200 (2 pakketti ta' 100) pillola miksija b'rita
English: Only use the 3 ml syringe included in the package.
Maltese: Uża biss is-siringa ta' 3 ml inkluża fil-pakkett.
English: EU/1/00/146/023 50 tablets
Maltese: EU/1/00/146/023 50 pillola
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents and children 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: Results related to behavioural and emotional functioning indicated a worsening in levetiracetamtreated patients on aggressive behaviour as measured in a standardised 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' Keppra f'imġieba aggressive kif imkejjel b'mod standardizzat u sistematiku bl-użu ta' strument validat (CBCL - Achenbach Child Behavior Checklist).
English: See Table 1 for the recommended preparation and administration of Keppra concentrate for solution for infusion to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg in two divided doses.
Maltese: Ara iskeda 1 għall-preparazzjoni rikkmandata kif ukoll il-metodu rikmandat ta' kif jingħata l-konċentrat Keppra biex tilħaq doża totali ta' 500 mg, 1000 mg, 2000 mg, jew 3000 mg kuljum, f'żewġt dożi separati.
English: Keppra 500 mg film-coated tablets are yellow, 16 mm oblong, scored and debossed with the code “ucb” and “500” on one side.
Maltese: Keppra 500 mg pilloli miksija b'rita huma sofor, 16 mm tawwalin, maqtuha minn nofs u mnaqqxa bilkodiċi “ucb” u “500” fuq naħa waħda.
English: EU/1/00/146/016 50 tablets
Maltese: EU/1/00/146/016 50 pillola
English: Keppra 250 mg Justification for not including Braille accepted 100 x 1 tablets
Maltese: Il-ġustifikazzjoni biex ma jkunx inkluż Braille hija aċċettata 100 x 1 pillola
English: Three presentations are available: - A 300 ml bottle with a 10 ml oral syringe (delivering up to 1000 mg levetiracetam) graduated every 0.25 ml (corresponding to 25 mg).
Maltese: - Flixkun ta' 300 ml b'siringa orali ta' 10 ml (li tagħti sa 1000 mg ta' levetiracetam) b'marka tal kejl kull 0.25 ml (ekwivalenti għal 25 mg).
English: Creatinine clearance (ml/min/1.73 m
Maltese: Rata ta' tneħħija talkrejatinina (ml/min/1.73 m2)
English: Keppra tablets are packaged in blister packs supplied in cardboard boxes containing:
Maltese: Il-pilloli Keppra huma ppakkjati f'f'folji f'kaxxai tal-kartun li fihom:
English: Starting dose: 7 mg/kg twice daily
Maltese: Doża tal-bidu: 7 mg/kg darbtejn kuljum
English: Keppra 1000 mg film-coated tablets Levetiracetam
Maltese: Keppra 1000 mg pilloli miksija b' rita Levetiracetam
English: Yellow, 16 mm oblong, scored and debossed with the code “ucb” and “500” on one side.
Maltese: Safra, 16 mm tawwalija, maqtuha minn nofs u mnaqqxa bil-kodiċi “ucb” u ”500” fuq naħa waħda.
English: EU/1/00/146/020 10 tablets
Maltese: EU/1/00/146/020 10 pillola
English: What Keppra looks like and contents of the pack Keppra 250 mg film-coated tablets are blue, 13 mm oblong, scored and debossed with the code “ucb” and “250” on one side.
Maltese: Keppra 250 mg pilloli miksija b'rita huma blu, 13mm tawwalin, maqtuha minn nofs u mnaqqxa bilkodiċi “ucb” u “250” fuq naħa waħda.
English: Keppra 750 mg film-coated tablets Levetiracetam
Maltese: Keppra 750 mg pilloli miksija b' rita Levetiracetam
English: One tablet of Keppra 500 mg contains 500 mg of levetiracetam.
Maltese: Pillola waħda ta' Keppra 500 mg fih 500 mg levetiracetam.
English: Keppra concentrate for solution for infusion is packed in a cardboard box containing 10 vials of 5 ml.
Maltese: Il-konċentrat ta' soluzzjoni għall-infużjoni Keppra issibhom f'kaxxi tal-kartun li fiha 10 vjali ta' 5 ml.
English: 1.25 ml twice daily
Maltese: 1.25 ml darbtejn kuljum
English: EU/1/00/146/021 20 tablets
Maltese: EU/1/00/146/021 20 pillola
English: Dose and frequency (1) Infants 1 to less than 6 months
Maltese: Doża u frekuenza (1) Trabi ta' bejn xahar sa inqas minn 6 xhur
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 17-il sena) li jiżnu inqas minn 50 kg
English: Starting dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily
Maltese: Doża massima: 0.3 ml/kg darbtejn kuljum
English: Keppra 100 mg/ml sterile concentrate Levetiracetam
Maltese: Keppra 100 mg/ml konċentrat għal soluzzjoni għall-infużjoni 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: EU/1/00/146/021 EU/1/00/146/022 EU/1/00/146/023 EU/1/00/146/024 EU/1/00/146/025 EU/1/00/146/026 EU/1/00/146/037
Maltese: EU/1/00/146/021 EU/1/00/146/022 EU/1/00/146/023 EU/1/00/146/024
English: 0.6 ml twice daily
Maltese: 0.6 ml darbtejn kuljum
English: Box of 10, 20, 30, 50, 60, 100, 100 (100 x 1), 120
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA ta' 10, 20, 30, 50, 60, 100, 100 (100 x 1), 120
English: Starting dose: 0.07 ml/kg twice daily Maximum dose: 0.21 ml/kg twice daily
Maltese: Doża massima: 0.21 ml/kg darbtejn kuljum
English: Keppra 1000 mg film-coated tablets
Maltese: Keppra 1000 mg pilloli miksija b'rita
English: Keppra 750 mg film-coated tablets
Maltese: Keppra 750 mg pilloli miksija b'rita
English: 0.35 ml twice daily
Maltese: 0.35 ml darbtejn kuljum
English: There is no specific antidote for levetiracetam.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni orali.
English: The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of foetuses with cardiovascular/skeletal anomalies.
Maltese: Il-livell tad-doża ta' 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: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child 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: Two embryo-foetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg/kg/day.
Maltese: Żewġt studji fuq l-iżvillup ta' l-embriju u l-fetu (EFD) saru fil-far b'400, 1200 u 3600 mg/kg/ġurnata.
English: − Keep this leaflet.
Maltese: Likwidu ċar.
English: The starting dose for a child or adolescent of 25kg should be 250mg twice daily with a maximum dose of 750mg 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: 0.45 ml twice daily
Maltese: 0.45 ml darbtejn kuljum
English: Keppra 250 mg film-coated tablets Levetiracetam
Maltese: Keppra 250 mg pilloli miksija b' rita Levetiracetam
English: 5 ml glass vial (type I) closed by a polytetrafluoroethylene grey chlorobutyl rubber stopper or an uncoated grey bromobutyl rubber stopper and sealed with an aluminium/polypropylene flip cap. Each carton contains 10 vials.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih vjala tal-ħġieġ (tip I) ta' 5 ml magħluqa b'għatu tal-gomma polytetrafluoroethylene chlorobutyl griż jew b'għatu tal-gomma bromobutyl griż li mhux miksi u ssiġillata b'tap li jinqala' tal-aluminjum /polypropylene.
English: The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness.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 lanaliżi ta' ġabra ta' provi kliniċi kkontrollati bil-plaċebo fejn ġew studjati l-indikazzjonijiet kollha, b'total ta' 3,416 pazjent trattati b'levetiracetam.
English: EU/1/00/146/001 EU/1/00/146/002 EU/1/00/146/003 EU/1/00/146/004 EU/1/00/146/005 EU/1/00/146/029 EU/1/00/146/034
Maltese: EU/1/00/146/001 EU/1/00/146/002 EU/1/00/146/003 EU/1/00/146/004
English: EU/1/00/146/014 20 tablets
Maltese: EU/1/00/146/014 20 pillola
English: Keppra concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Maltese: Il-konċentrat Keppra huwa għall-użu minn ġol-vina biss u d-doża rikkmandata trid tiġi dilwita f' millinqas 100 ml ta' dilwent kompattibli u tingħata b'infużjoni minn ġol-vina fuq medda ta' 15 il-minuta (ara sezzjoni 6.6).
English: Intermediate packaging containing 100 tablets for box of 200 (2 x 100) tablets without blue box
Maltese: U KONTENUT Pakkett multiplu, 200 (2 pakketti ta' 100) pilloli miksija b'rita
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: 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: The 150 ml glass bottle of Keppra (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' 150 ml ta' Keppra (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 edepter għas-siringa.