FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/741/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/741/001
English: Special populations
Maltese: Popolazzjonijiet specjali
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 December 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data l-ewwel awtorizzazzjoni: 14 Diċembru 2011
English: Metabolism and nutrition disorders
Maltese: Mard talmetaboliżmu u nutrizzjoni
English: Musculoskeletal and connective tissue disorders
Maltese: Mard muskoluskeletali u tat-tessut konnettiv
English: Oral contraceptives and other pharmacokinetics interactions 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: Levetiracetam 1,000 mg me kellu ebda effett fuq il-farmakokinetika ta' kontraċettivi orali (ethinylestradiol u levonorgestrel); parametric endokrinarji ( luteinizing hormone u progesterone).
English: confusion, panic attack, emotional instability/mood swings, agitation - amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia
Maltese: konfużjoni, attakk ta' paniku, instabilta` emozzjonali/tibdil fil-burdati, agitazzjoni; - amneżija (telf ta' memorja),impediment tal- memorja (tinsa), ko-ordinazzjoni abnormali/ataxja
English: • Risk management plan (RMP) Not applicable.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli.
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 <1/100); rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000).
Maltese: Ir-reazzjonijiet avversi kienu ppreżentati f'ordni ta' gravita` minn ħafna għal ftit u il-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) u rari:
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis)
Maltese: Reazzjoni għallmediċina b'esinofilja u sintomi sistemiċi (DRESS), ipersensittivita` (inkluż anġjoedima u anafillassi
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: • Periodic safety update reports (PSURs) The requirements for submission of PSURs 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: • Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs) Ir-rekwiżiti biex jiġu ppreżentati PSURsgħal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 500 mg/5 ml levetiracetam.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Vjala waħda fiha 500 mg /5 ml levitiracetam.
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: 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%), u telqa (komuni, 3.9%) kienu rappurtati iżjed frekwentament minn gruppi ta' etajjiet oħra jew mill-profil ta' sigurta` totali.
English: One vial of Levetiracetam SUN concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
Maltese: Vjala waħda ta' Levetiracetam SUN fiha 500 mg ta' levetiracetam (5 ml ta' konċentrat ta' 100 mg/ml ).
English: Diluents: - Sodium chloride 9 mg/ml (0.9%) solution for injection - Lactated Ringer's solution for injection - Dextrose 50 mg/ml (5%) solution for injection
Maltese: Dilwenti: - soluzzjoni għall-injezzjoni sodium chloride 9 mg/ml (0.9%) - soluzzjoni għall-injezzjoni Lactated Ringer - soluzzjoni għall-injezzjoni Dextrose 50 mg/ml (5%)
English: Maximum dose: 30 mg/kg twice daily
Maltese: Doża Massima: 30 mg/kg darbtejn kuljum
English: General dose: between 1,000 mg and 3,000 mg each day.
Maltese: Doża ġenerali: bejn 1,000 mg u 3,000 mg kuljum.
English: Sodium acetate trihydrate Glacial acetic acid Sodium chloride Water for injection
Maltese: Sodium acetate trihydrate Glacial acetic acid Sodium chloride Ilma għall-injezzjonijiet
English: A peri- and post-natal development study was performed in rats with levetiracetam doses of 70, 350 and 1800 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 1800 mg/kg/ġurnata.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (1) (2)
Maltese: 10 sa 20 mg/kg (0.10 sa 0.20 ml/kg) darba kuljum (1) (2)
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-iżvillup tal-embriju u l-fetu saru fil-fniek li koprew dożi ta' 200, 600, 800, 1200 u 1800 mg/kg/ġurnata.
English: This medicinal product contains 2.5 mmol (or 57 mg) sodium per maximum single dose (0.8 mmol (or 19 mg) per vial).
Maltese: Din il-mediċina fiha 2.5 mmol (jew 57 mg) ta' sodju f'doża singola massima (0.8 mmol (jew 19 mg) kull vjala).
English: The intravenous administration of doses up to 4000 mg diluted in 100 ml of 0.9% sodium chloride infused over 15 minutes and doses up to 2500 mg diluted in 100 ml of 0.9% sodium chloride infused over 5 minutes was evaluated.
Maltese: Kienu evalwati, it-teħid minn ġol-vina ta' dożi sa 4000 mg miżjudin b' 100 ml ta' 0.9 % sodium chloride b'infużjoni f' 15 il-minuta u dożi sa 2500 mg miżjudin b' 100 ml ta' 0.9 % sodium chloride b'infużjoni f' 5 minuti.
English: Pancytopenia neutropenia, agranulocytosis
Maltese: Pansitopenja,, newtropenja, agranuloċitiżi
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: Other unidentified components accounted only for 0.6 % of the dose.
Maltese: Komponenti oħrajn li ma ġewx identifikati jagħmlu biss 0.6 % middoża kollha.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibli fil-preżent huma deskritti f'sezzjonijiet 4.8, 5.1, u 5.2 iżda ma jistgħux isiru rakkomandazzjonijiet fuq pożoloġija.
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: 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 fuq bażi ta' mg/m2) u 1200 mg/kg/ġurnata għal feti.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Maltese: Is-sustanza attiva, levetiracetam hija derivattiva ta' pyrrolidone (S-enantiomer ta' α-ethyl-2-oxo-1pyrrolidine acetamide), u ma jixbaħx kimikament lil sustanzi attivi oħrajn li jintużaw kontra lepilessija.
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/m2).
English: The mechanism of this risk is not known.
Maltese: Il- mekkaniżmu ta' dan ir-riskju mhux magħruf.
English: Deutschland Sun Pharmaceuticals Germany GmbH
Maltese: Sun Pharmaceuticals Germany GmbH Hemmelrather Weg 201
English: Levetiracetam SUN is packed in colorless tubular glass vial (type I) with 20 mm grey bromobutyl rubber stopper sealed with white flip-top aluminum seal.
Maltese: Levetiracetam SUN hu ppakkjat fi vjali tal-ħġieġ (tip I) tubulari bla kulur b'tapp tal-lasktu griż ta' 20 mm tal-bromobutyl issiġillati b'siġill abjad flip-top tal-aluminju.
English: One maximum single dose of Levetiracetam SUN 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' Levetiracetam SUN fiha 2.5 mmol (jew 57 mg) ta' sodju (0.8 mmol (jew 19 mg) ta' sodju f'kull vjala).
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: 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: 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 ta' 6.0 sigħat.
English: In adults, levetiracetam efficacy has been demonstrated in 3 double-blind, placebo-controlled studies at 1000 mg, 2000 mg, or 3000 mg/day, given in 2 divided doses, with a treatment duration of up to 18 weeks.
Maltese: F'adulti, l-effiċjenza ta' levetiracetam kiem muri fi 3 studji double-blind ikkontrollati minn plaċebo f dożi ta' 1000 mg, 2000 mg, jew 3000 mg/ kuljum, mogħtija f' 2 dożi separati, b'trattament li dam sa 18 il-ġimgħa.
English: (1) A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: (1) Doża kbira ta' 15 mg/kg (0.15 ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
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 ġenerali: bejn 20 mg kull kg kg tal-piz tal-ġisem u 60 mg kull kg tal-piz tal-ġisem kuljum.
English: The CLcr in ml/min/1.73 m2 may be estimated from serum creatinine (mg/dl) determination using, 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: Add-on therapy for children aged 4 to 11 years and adolescents (12 to 17 years) weighing less than 50 kg
Maltese: Terapija miżjuda fit- tfal ta' 4 sa 11-il sena u addoloxxenti (12 sa 17-il sena) li jiżnu inqas minn 50 kg
English: Nervous system disorders
Maltese: Mard tas-sistema nervuża
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14.
Maltese: Kategorija farmakoterapewtika: mediċini għall-kontra l-epilessija, mediċini għall-kontra lepilessija oħra, Kodiċi ATC:
English: The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group.
Maltese: Il-mod prinċipali kif jiġi metabolizzat (24 % tad-doża) huwa permezz ta' idroliżi tal-grupp aċetamajd.
English: Creatinine clearance Dose and frequency (ml/min/1.73 m2)
Maltese: Rata ta' tneħħija talkrejatinina (ml/min/1.73 m2)
English: 1500 mg 15 ml (three 5 ml vials) 100 ml
Maltese: 1500 mg 15 ml (tlett vjali ta' 5ml) 100 ml 15 minuti Darbtejn kuljum
English: 1500 mg twice daily (1) Children 25 kg or less should preferably start the treatment with an oral solution.
Maltese: Tfal ta' 25 kg jew inqas għandhom preferabilment jibdew it-trattament b'soluzzjoni orali.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour 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 talimġieba 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: 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 fepilessija).
English: Creatinine clearance (ml/min/1.73 m2)
Maltese: Tneħħija talkrejatinina (ml/min/1.73 m2)
English: Common: may affect up to 1 in 10 people - anorexia (loss of appetite) - depression, hostility or aggression, anxiety, insomnia, nervousness or irritability - convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
Maltese: Komuni: jista'jaffettwa minn sa 1 f' 10 persuna - anoressija (telf t'aptit); - depressjoni, ostilita` jew aggressjoni, anzjeta`, insomnja, nervożita` jew irritabilta`; - aċċessjonijiet, mard tal-bilanċ (mard tal-ekwilibru), sturdament (sensazzjoni ta' ċaqliq), telqa
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam).
Maltese: Suwiċidju, attentat ta' suwiċidju, ħsibijiet u mġieba suwiċidali kienu rrappurtati f'pazjenti trattati b' mediċini ta' kontra l-epilessija (inkluż levetiracetam).
English: Levetiracetam SUN concentrate for solution for infusion 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 Levetiracetam SUN 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: Serum Creatinine (mg/dl) ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male Dosing adjustment for children and adolescents patients weighing less than 50 kg with impaired renal function
Maltese: ks= 0.55 f' Tfal sa inqas minn 13-il sena u f'addoloxxenti feminili; ks= 0.7 f' addoloxenti maskili
English: Rare: may affect up to 1 in 1,000 people - infection - decreased number of all blood cell types - severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat])) - decreased blood sodium concentration - suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate) - delirium - encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms) - uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity) - pancreatitis - liver failure, hepatitis - sudden decrease in kidney function - 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) rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase.
Maltese: • delirju; - enċefalopatija (ara sottosezzjoni “Għid lit-tabib tiegħek immedjatament” għal deskrizzjoni dettaljata tas-sintomi); - spażmi fil-muskoli inkontrollablili jaffetwaw ir-ras, it-torso u d-dirgħajn u r-riġlejn, diffikulta` biex tikkontrolla l-movimenti, iperkineżja (iperattività); - pankreatite; - insuffiċjenza tal-fwied, epatite; - tnaqqis f'daqqa fil-funzjoni tal-kliewi; - 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); - rabdomilożi (it-tkissir tat-tessut tal-muskoli) u żieda assoċjata fil-creatinine phosphokinase fiddemm.
English: (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration) - diplopia (double vision), vision blurred - elevated/abnormal values in a liver function test - hair loss, eczema, pruritus - muscle weakness, myalgia (muscle pain) - injury
Maltese: (impediment fil-movimenti ko-ordinati), paraesteżja (tingiż), disturbi fl-attenzjoni (telf ta'konċentrazzjoni); - diplopja (viżjoni dopplja), viżjoni mċajpra; - valuri għolja/abnormali fit-test tal-funzjoni tal-fwied; - telf ta' xahar, ekżema, ħakk; - debolezza fil-muskoli, mijalġja (uġigħ fil-muskoli); - korriment.
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, panic attack, affectlability/mood swings, agitation
Maltese: Attenta ta' suwiċidju, ħsibijiet ta' suwiċidju, mard psikotiċi, mġieba abnormali, alluċinazzjonijiet, rabja, stat konfużjonali, attakk ta' paniku, tibdil fl-emozzjonijiet/tibdil fil-burdati, agitazzjoni
English: Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms.
Maltese: L-iżoformi taċ-ċitokromju P450 filfwied ma jgħinux il-produzzjoni ta' ucb L057, li huwa l-prodott ewlieni tal-metaboliżmu.
English: - The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injection.
Maltese: - Sustanzi oħra jinkludu: sodium acetate trihydrate, glacial acetic acid, sodium chloride, ilma għall-injezzjoni
English: A single dose of 1500 mg levetiracetam diluted in 100 ml of a compatible diluent and infused intravenously over 15 minutes is bioequivalent to 1500 mg levetiracetam oral intake, given as three 500 mg tablets.
Maltese: Doża waħda ta' 1500 mg ta' levetiracetam miżjud b' 100 ml ta' dilwent kompattibli u li jittieħed b'infużjoni minn ġol-vina f' 15 il-minuta hija bijoekwivalenti għal 1500 mg ta' levetiracetam li tittieħed mill-ħalq, u li tingħata bħala tlett pilloli ta' 500 mg.
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: Rhabdomyolysis and blood creatine phosphokinase increased*
Maltese: Rabdomijolożi u żieda filcreatinine phosphokinase fid-demm*
English: Each carton contains 10 vials.
Maltese: Kull kaxxa tal-kartun fiha 10 vjali.
English: (2) Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Maltese: (2) Wara id-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 5 u 10 mg/kg (0.05 sa 0.10 ml/kg).
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 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: See Table 1 for the recommended preparation and administration of Levetiracetam SUN concentrate for solution for infusion 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 Levetiracetam SUN biex tilħaq doża totali ta' 500 mg, 1000 mg, 2000 mg, jew 3000 mg kuljum, f'żewġt dożi separati.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Mard respiratorju toraċiku u medjastinali
English: Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening).
Maltese: 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: Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Maltese: Terapija miżjuda fit-trattament ta' aċċessjonijiet ġeneraliżżati primarji tat-tip tonic-clonic f' adulti u addoloxxenti minn 12 il-sena b'epilessija ġeneralizzata idjopatika.
English: Other medicines and Levetiracetam SUN
Maltese: Mediċini oħra u Levetiracetam SUN
English: 750 mg twice daily
Maltese: 750 mg darbtejn kuljum