FrancophonIA/ELRC3.0 huggingface dataset:
English: Contains sorbitol (E420), sodium methyl parahydroxybenzoate (E219), aspartame (E951), and sodium.
Maltese: Fih sorbitol (E420), sodium methyl parahydroxybenzoate (E219) u aspartame (E951) u sodju.
English: The percent reduction over placebo based on analysis of covariance was 31.72 % (95 % CI: 16.342,44.277).
Maltese: Il-perċentwali ta' tnaqqis fuq il-plaċebo bbażat fuq l-analiżi tal-kovarjanza kien ta' 31.72 % (95 % CI: 16.342,44.277).
English: 100 mg/day or 200 mg/day 100 mg/day
Maltese: 100 mg/jum jew 200 mg/jum 100 mg/jum
English: Lacosamide is rapidly and completely absorbed after oral administration.
Maltese: Lacosamide huwa assorbit rapidament u kompletament wara amministrazzjoni mill-ħalq.
English: The active substance is lacosamide.
Maltese: • Is-sustanza attiva hija lacosamide.
English: The body weight normalized difference is 26 and 23 %, respectively.
Maltese: Id-differenza normalizzata tal-piz tal-ġisem kienet ta' 26 u 23% rispettivament.
English: PHARMACEUTICAL FORM AND CONTENTS 200 mg/20 ml
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 200 mg/20 ml
English: Maximum recommended dose up to 600 mg/day up to 400 mg/day
Maltese: Doża massima rakkomandata sa 600 mg/jum sa 400 mg/jum
English: pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %).
Maltese: 7 %), rimettar (14.7 %), ħedla ta' ngħas (14.0 %), sturdament (13.5 %), deni (13.0 %), konvulżjoni (7.8 %), nuqqas ta' aptit (5.9 %), farinġite (4.7 %), letarġija (2.7 %) u mġiba anormali (1.7 %).
English: Statistically significant (p=0.0003) and clinically relevant reduction in partial-onset seizure frequency per 28 days from baseline to the maintenance period was observed between the lacosamide and the placebo group.
Maltese: Ġie osservat tnaqqis statistikament sinifikanti (p=0.0003) u klinikament rilevanti fil-feġġa parzjali talfrekwenza ta' aċċessjonijiet f'28 jum mil-linja bażi għall-perjodu ta' manteniment bejn il-grupp tallacosamide u tal-plaċebo.
English: Laboratory abnormalities
Maltese: Abnormalitajjiet fil-laboratorju
English: Drug reaction with eosinophilia and systemic symptoms (DRESS) (1,2)
Maltese: Reazzjoni talmediċina b'esinofilja u sintomi sistemiċi (DRESS) (1,2)
English: Component of a multipack, can't be sold separately.
Maltese: Parti minn pakkett multiplu, ma jistax jinbiegħ separatament.
English: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone (polyplasdone XL-10 Pharmaceutical Grade), magnesium stearate.
Maltese: Qalba tal-pilloli: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone (polyplasdone XL-10
English: Convulsion(3)
Maltese: Konvulsjoni (3)
English: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Maltese: UCB Pharma S.A., Chemin du Foriest, B-1420
English: Lacosamide UCB syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria.
Maltese: Lacosamide UCB mistura fiha aspartame (E951), sors ta' phenylalanine, li tista' tkun ta' ħsara għal nies bi phenylketonuria.
English: Fainting;
Maltese: • sturdament;
English: Itching, rash.
Maltese: • Ħakk, raxx.
English: Irritability Feeling drunk Injection site pain or discomfort (4) Irritation(4)
Maltese: Uġigħ fis-sit talinjezzjoni jew skonfort(4) irritazzjoni(4)
English: Hepatic enzyme increased (> 2x ULN) (1)
Maltese: Żieda fl-enżimi tal-fwied (> 2x ULN) (1)
English: The metabolism of lacosamide has not been completely characterised.
Maltese: Il-metaboliżmu ta' lacosamide ma kienx kompletament ikkaratterizzat.
English: Agranulocytosis(1)
Maltese: Agranuloċitożi(1)
English: Potential for electro-clinical worsening in specific paediatric epilepsy syndromes
Maltese: Potenzjal għal aggravar elettro-kliniku f'sindromi ta' epilessija perdjatrika speċifiċi
English: Allée de la Recherche 60 B-1070 Bruxelles Belgium
Maltese: B-1070 Brussel Belġju
English: A total of 67.8 % of patients randomised to lacosamide and 58.1 % of patients randomised to placebo reported at least 1 adverse reaction.
Maltese: Total ta' 67.8 % tal-pazjenti randomizzati għal lacosamide u 58.1 % tal-pazjenti randomizzati għal plaċebo rrappurtaw mill-inqas reazzjoni avversa waħda.
English: Small amounts (0.5-2 %) of additional metabolites were found in the urine.
Maltese: Ammonti żgħar (0.5-2%) ta' prodotti tal-metaboliżmu addizjonali kienu misjuba fl-awrina.
English: For the full list of excipients, see section 6.1.
Maltese: Għall- lista sħiħa ta' eċċipjenti, ara s-sezzjoni 6.1.
English: Outer carton / bottle
Maltese: Pakkett ta' barra / flixkun
English: Bradycardia(1,2) Atrial Fibrillation Atrial Flutter (1,2)
Maltese: Bradikardja(1.2) Fibrillazzjoni atrijali(1,2) Taħbit atrijali rregolari(1,2)
English: 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 0.5 ml/kg Maximum recommended dose: 0.6 ml/kg
Maltese: 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 0.5 ml/kg Doża massima rakkomandata:
English: (2) See Description of selected adverse reactions.
Maltese: (2) Ara Deskrizzjoni ta' reazzjonijiet avversi magħżula.
English: In non-clinical experiments lacosamide in combination with levetiracetam, carbamazepine, phenytoin, valproate, lamotrigine, topiramate or gabapentin showed synergistic or additive anticonvulsant effects.
Maltese: F'esperimenti mhux kliniċi, lacosamide flimkien ma' levetiracetam, carbamazepine, phenytoin, valproate, lamotrigine, topiramide jew gabapentin wera effetti ta' kontra l-epilessija sinerġistiċi jew addittivi.
English: There was no clinically relevant interaction between lacosamide and metformin.
Maltese: Ma kienx hemm effett klinikament relevanti bejn lacosamide u metformin.
English: Lacosamide UCB 200 mg film-coated tablets: indigo carmine aluminium lake (E132) 6.2 Incompatibilities
Maltese: Lacosamide UCB 200 mg pilloli miksijin b'rita: indigo carmine aluminium lake (E132) 6.2 Inkompatibilitajiet
English: The packages are marked with ‘week 1 (2, 3 or 4)'.
Maltese: Il-pakketti huma mmarkati b' ‘ġimgħa 1(2, 3 jew 4)'.
English: Atrioventricular block(1,2)
Maltese: Blokk Atrijoventrikulari(1
English: Gait disturbance Asthenia
Maltese: Disturbi fil- qal
English: In treated patients who completed titration and started withdrawing antiepileptic medicinal products (284 and 99 respectively), monotherapy was maintained in 71.5 % and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation period of 70 days.
Maltese: Fil-pazjenti trattati li lestew it-titrazzjoni u bdew innaqqsu l-prodotti ta' kontra l-epilessija ( 284 u 99 rispettivament), monoterapija kienet mantenuta f' 71.5 % u 70.7 % tal-pazjenti rispettivament għal 57-105 ġurnata (medda ta' 71 ġurnata), fuq il-perjodu ta' osservazzjoni mmirrat ta' 70 ġurnata.
English: Lacosamide UCB is available in packs of 14, 28, 56, 14 x 1 and 56 x 1 film-coated tablets and in multipacks comprising 3 cartons, each containing 56 tablets.
Maltese: Lacosamide UCB issibu f'pakketti ta' 14, 28, 56, 14 x 1 u 56 x 1 pilloli miksija b'rita u f'pakketti multipli li jikkonsistu f'3 kaxxi, kull waħda fiha 56 pillola.
English: Maximum recommended dose: 0.4 ml/kg
Maltese: Doża massima rakkomandata: 0.4 ml/kg
English: The Kaplan-Meier estimates of 12-month seizure freedom rates were 77.8 % for lacosamide-treated patients and 82.7 % for carbamazepine CR treated patients.
Maltese: L-istimi Kaplan-Meier ta' estimates rati ta' tnax-il xahar ħielsa minn aċċessjonijiet kienu ta' 77.8% għal pazjenti ttrattati b' lacosamide u 82.7% għal pazjenti ttrattati b' carbamazepine CR.
English: Lacosamide did not affect the pharmacokinetics of omeprazole (metabolised by CYP2C19 and CYP3A4, lacosamide given 300 mg twice a day).
Maltese: Lacosamide ma kellux effett fuq il-farmakokinetika ta' omeprazole (immetabolizzat b' CYP2C19 u CYP3A4, lacosamide jingħata 300 mg darbtejn kuljum).
English: 150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Maltese: Pilloli 150 mg: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
English: Lacosamide UCB contains lacosamide.
Maltese: Lacosamide UCB fih lacosamide.
English: Abnormalities in liver function tests have been observed in placebo-controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic medicinal products.
Maltese: Abnormalitajjiet fit-testijiet tal-funzjoni tal-fwied kienu osservati f'provi kkontrollati bi plaċebo b'lacosamide f'pazjenti adulti b'aċċessjonijiet tat-tip partial-onset li kienu qegħdin jieħdu minn 1 sa 3 prodotti mediċinali ta' kontra l-epilessija f'daqqa.
English: The estimated 6-month seizure freedom rates were 89.8 % for lacosamide-treated patients and 91.1 % for carbamazepine CR treated patients using the Kaplan-Meier survival analysis method.
Maltese: Ir-rati ta' sitt xhur ħielsa minn aċċessjonijiet kienu smati għal 89.8% għal pazjenti ttrattati b' lacosamide u 91.1% għal pazjenti fuq carbamazepine CR treated patients billi intużat il-metodu ta' analiżi tas-sopravivenza Kaplan-Meier.
English: The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historicalcontrolled, multicentre, double-blind, randomised trial.
Maltese: L'effikaċja u s-sigurta` ta' lacosamide fil-bdil għal monotherapy kienet mkejjla f' prova randomizzata, double-blind, multiċentrali, u ikkontrollata bl-istorja.
English: Film-coat: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants*.
Maltese: Kisja ta-rita: polyvinyl alcohol, polyethylene glycol, terra, titanium dioxide (E171), sustanzi koloranti*.
English: Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
Maltese: • Sodium methyl parahydroxybenzoate (E219) jista' jikkawża reazzjonijiet allerġiċi (possibbilment imdewma).
English: Diluents: sodium chloride 9 mg/ml (0.9 %) solution for injection glucose 50 mg/ml (5 %) solution for injection lactated Ringer's solution for injection.
Maltese: Sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni Dextrose 50 mg/ml (5%) soluzzjoni għall-injezzjoni soluzzjoni għall-injezzjoni lactated Ringer's
English: Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
Maltese: • Movimenti tal-għajnejn mgħaġġla u inkontrollabli (nystagmus), vista mċajpra;
English: Take off the adaptor from the oral syringe (figure 2).
Maltese: • Neħħi l-adapter mis-siringa orali (figura 2).
English: As from the 1 ml graduation mark, each graduation corresponds to 0.25 ml which is 2.5 mg of lacosamide.
Maltese: Mill-marka ta' kejl ta' 1 ml, kull gradwazzjoni tikkorrespondi għal 0.25 ml li hija 2.5 mg ta' lacosamide.
English: Week 1 Package marked "Week 1"
Maltese: Ġimgħa 1 Pakkett immarkat "Ġimgħa 1"
English: Lacosamide UCB tablets and oral syrup are bioequivalent.
Maltese: Lacosamide UCB pilloli u mistura orali huma bio-ekwivalenti.
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilita`, tqala u treddigħ
English: Nystagmus Hypoesthesia Dysarthria Disturbance in attention
Maltese: Nystagmus Ipoestesja Disartrija Disturbi fl' attenzjoni Paraestezja
English: Overall the proportion of subjects with a 50 % reduction in seizure frequency was 23 %, 34 %, and 40 % for placebo, lacosamide 200 mg/day and lacosamide 400 mg/day.
Maltese: Il-proporzjon ta' persuni fuq kollox bi tnaqqis ta' 50% fil-frekwenza ta' aċċessjonijiet kien ta' 23%, 34%,u 40% għal-plaċebo, lacosamide 200 mg/ġurnata u lacosamide 400 mg/ġurnata.
English: Children from 4 years and adolescents under 50 kg: use the oral syringe.
Maltese: Tfal minn 4 snin u adoloxxenti inqas minn 50 kg: uża s-siringa orali.
English: These medicines are used to treat epilepsy.
Maltese: Prodotti mediċinali ta' kontra l-epilessija
English: This will be until you reach a maintenance dose of between 100 mg (10 ml) and 200 mg (20 ml) twice a day.
Maltese: Dan se jkun sakemm tilħaq id-doża ta' manteniment ta' bejn 100 mg (10 ml) u 200 mg (20 ml) darbtejn kuljum.
English: Film-coated tablet
Maltese: Diffikulta` filmixi
English: 1 ml Lacosamide UCB syrup contains 10 mg lacosamide.
Maltese: 1 ml mistura Lacosamide UCB fiha 10 mg lacosamide.
English: Excipients which may cause intolerance
Maltese: Eċċipjenti jistgħu jikkawżaw intolleranza
English: Listed below are the normal recommended doses of Lacosamide UCB for different age groups and weights.
Maltese: Hawn taħt hawn imniżżlin id-dożi rakkomandati normali ta' Lacosamide UCB għal gruppi ta' età u piżijiet differenti.
English: The discontinuation rate due to adverse events observed with lacosamide was 21.0 % (13/62) in elderly patients versus 9.2 % (35/382) in younger adult patients.
Maltese: Ir-rata ta' twaqqif minħabba ġrajjiet avversi osservata b' lacosamide kienet ta' 21.0% (13/62) f'pazjenti anzjani versus 9.2% (35/382) f'pazjenti adulti iżgħar.
English: Maximum recommended dose in patients ≥ 30 kg to < 50 kg up to 8 mg/kg/day
Maltese: Doża massima f'pazjenti ≥ 30 kg sa < 50 kg sa 8 mg/kg/jum
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 168 (3 packs of 56) film-coated tablets
Maltese: U KONTENUT Pakkett multiplu:168 (3 pakketti ta' 56) pilloli miksija b'rita
English: The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment (see section 4.2).
Maltese: Il-farmakokinetika ta' lacosamide ma ġiex studjat f' indeboliment sever tal-fwied (ara s-sezzjoni 4.2).
English: Each ml of Lacosamide UCB syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl parahydroxybenzoate (E219), 0.032 mg aspartame (E951), and 1.42 mg sodium.
Maltese: Kull ml ta' mistura Lacosamide UCB fiha 187 mg sorbitol (E420),2.60 mg sodium methylparahydroxybenzoate (E219),0.
English: Lacosamide UCB syrup contains sodium methyl parahydroxybenzoate (E219), which may cause allergic reactions (possibly delayed).
Maltese: Lacosamide UCB mistura fiha sodium methyl parahydroxybenzoate (E219), li jista' jikkawża reazzjonijiet allerġiċi (possibilment imdewmin).
English: The 6-month seizure freedom rates in elderly patients of 65 and above (62 patients in lacosamide, 57 patients in carbamazepine CR) were similar between both treatment groups.
Maltese: Ir-rati ta' sitt xhur ħielsa minn aċċessjonijiet f' pazjenti anzjani ta' 65 sena ‘l fuq (62 pazjent fuq lacosamide, 57 pazjent fuq carbamazepine CR) kienu simili fiż-żewġ gruppi tat-trattament.
English: In adjunctive clinical trials in epilepsy patients the incidence rate of reported first-degree AV Block is uncommon, 0.7 %, 0 %, 0.5 % and 0 % for lacosamide 200 mg, 400 mg, 600 mg or placebo, respectively.
Maltese: F'provi kliniċi aġġuntivi f'pazjenti epilettiċi r-rata ta'l-inċidenza ta' blokk AV tal-ewwel grad rappurtat mhuwiex komuni, 0.7%, 0%, 0.5% u 0% għal lacosamide 200 mg, 400 mg, 600 mg jew placebo, rispettivament.
English: The minimum extractable volume is 1 ml, which is 10 mg of lacosamide.
Maltese: Il-volum estratt minimu huwa ta' 1 ml, li huwa 10 mg ta' lacosamide.
English: No dose adjustment is necessary in mildly and moderately renally impaired adult and paediatric patients (CLCR > 30 ml/min).
Maltese: M'hemmx bżonn ta' aġġustament f'pazjenti adulti u pedjatriċi b'indeboliment ħafif jew moderat talkliewi (CLCR >30 ml/min).
English: Multipacks containing 168 (3 packs of 56 tablets) film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Maltese: Pakketti multipli li fihom 168 (3 pakketti ta' 56 pillola) pillola miksija b'rita f'folja tal-PVC/PVDC siġillata b'fojl tal-aluminju.
English: Cardiac rhythm and conduction
Maltese: Ritmu u konduzzjoni kardiaċi
English: Irritability, trouble sleeping, depression;
Maltese: • Irritibiltà, tbagħti biex torqod, depressjoni;
English: Week 4 Package marked "Week 4"
Maltese: Ġimgħa 4 Pakkett immarkat "Ġimgħa 4"
English: Week 2 Package marked "Week 2"
Maltese: Ġimgħa 2 Pakkett immarkat "Ġimgħa 2"
English: UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Somija)
Maltese: UCB Pharma Oy Finland Tel: + 358 9 2514
English: The typical plasma clearance was estimated to be 1.04 L/h, 1.32 L/h and 1.86 L/h for children weighing 20 kg, 30 kg and 50 kg respectively.
Maltese: 32 L/siegħa u 1.86 L/siegħa għal tfal li jiżnu 20 kg, 30 kg u 50 kg rispettivament.
English: Children (from 4 years of age) and adolescents weighing less than 50 kg
Maltese: Tfal (minn età ta' 4 snin) u adoloxxenti li jiżnu inqas minn 50 kg
English: Instructions for use: oral syringe
Maltese: Istruzzjonijet għall-użu: siringa orali
English: EU/1/19/1383/010 EU/1/19/1383/011 EU/1/19/1383/012 EU/1/19/1383/013 EU/1/19/1383/014 EU/1/19/1383/015 EU/1/19/1383/016 EU/1/19/1383/017 EU/1/19/1383/018 EU/1/19/1383/019 EU/1/19/1383/020 EU/1/19/1383/021 EU/1/19/1383/022 EU/1/19/1383/023 EU/1/19/1383/024 EU/1/19/1383/025 EU/1/19/1383/026 EU/1/19/1383/027
Maltese: EU/1/19/1383/015 EU/1/19/1383/016 EU/1/19/1383/017 EU/1/19/1383/018 EU/1/19/1383/019 EU/1/19/1383/020 EU/1/19/1383/021 EU/1/19/1383/022 EU/1/19/1383/023 EU/1/19/1383/024
English: 50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132).
Maltese: Pilloli 50 mg: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132).
English: In the elderly population, the maintenance lacosamide dose was 200 mg/day in 55 patients (88.7 %), 400 mg/day in 6 patients (9.7 %) and the dose was escalated to over 400 mg/day in 1 patient (1.6 %).
Maltese: Fil-popolazzjoni anzjana, iddoża ta' manteniment ta' lacosamide kienet ta' 200 mg/ġurnata f' 55 pazjent (88.7%), 400 mg/ġurnaf' 6 pazjenti (9.7%) u d-doża eskalat għal 400 mg/ġurnata f'pazjent 1 (1.6%).
English: Lacosamide UCB 100 mg film-coated tablets: yellow iron oxide (E172) Lacosamide UCB 150 mg film-coated tablets: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
Maltese: Lacosamide UCB 100 mg pilloli miksijin b'rita: yellow iron oxide (E172) Lacosamide UCB 150 mg pilloli miksijin b'rita: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
English: Co-administration of warfarin with lacosamide does not result in a clinically relevant change in the pharmacokinetics and pharmacodynamics of warfarin.
Maltese: It-teħid flimkien ta' warfarin ma' lacosamide ma jirriżultax f'bidla klinikament sinifikanti filfarmakokinetika u farmakodinamika ta' warfarin.
English: In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite.
Maltese: Data in vitro juri li CYP2C9, CYP2C19 u CYP3A4 jistgħu jikkatalizzaw il-formazzjoni tal-metabolit O-desmethyl.
English: This will be until you reach a maintenance dose of between 100 mg (10 ml) and 300 mg (30 ml) twice a day.
Maltese: Dan se jkun sakemm tilħaq id-doża ta' manteniment bejn 100 mg (10 ml) u 300 mg (30 ml) darbtejn kuljum.
English: Maximum recommended dose in patients < 40 kg up to 12 mg/kg/day Maximum recommended dose in patients ≥ 40 kg to < 50 kg up to 10 mg/kg/day
Maltese: Doża massima rakkomandata f'pazjenti < 40 kg sa 12 mg/kg/jum Doża massima rakkomandata f'pazjenti ≥ 40 kg sa < 50 kg sa 10 mg/kg/jum
English: 0.6 ml/kg (6 mg/kg) Maximum recommended dose
Maltese: 0.6 ml/kg (6 mg/kg) Doża massima rakkomandata
English: In juvenile dogs, transient and dose-related CNS clinical signs started to be observed at systemic exposure levels below the expected clinical exposure.
Maltese: CNS temporanji u relatati mad-doża bdew jiġu osservati f'livelli ta' esponiment sistemiku taħt lesponiment kliniku mistenni.
English: LIST OF EXCIPIENTS Contains sodium chloride, hydrochloric acid, water for injections.
Maltese: TA' EĊĊIPJENTI Fih sodium chloride, hydrochloric acid, ilma għall-injezzjoni.
English: • Fever (pyrexia);
Maltese: • Uġigħ fil-griżmejn (farinġite);
English: • The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 800 mg were not clinically different from those of patients administered recommended doses of lacosamide.
Maltese: • It-tipi ta' reazzjonijiet avversi esperjenzati minn pazjenti esposti għal dożi iżjed minn 400 mg sa 800 mg ma kienux klinikament differenti minn dawk f' pazjenti li ngħataw dożi rrikkmandati ta' lacosamide.
English: Week 3 Package marked "Week 3"
Maltese: Ġimgħa 3 Pakkett immarkat "Ġimgħa 3"
English: 0.5 ml/kg (5 mg/kg) Maximum recommended dose
Maltese: 0.5 ml/kg (5 mg/kg) Doża massima rakkomandata
English: Tablet coat polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171)
Maltese: Il-kisja tal-pillola polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171)
English: The pharmacokinetics and safety of a single loading dose of intravenous lacosamide were determined in a multicenter, open-label study designed to assess the safety and tolerability of rapid initiation of lacosamide using a single intravenous loading dose (including 200 mg) followed by twice daily oral dosing (equivalent to the intravenous dose) as adjunctive therapy in adult subjects 16 to 60 years of age with partial-onset seizures.
Maltese: Il-farmakokinetika u s-sigurta` ta' doża singola kbira tal-bidu ta' lacosamide għal ġol-vini kienu ddeterminati f' studju multiċentrali, open-label iddisinjat sabiex jkejjel is-sigurta` u t-tolerabilta` talbidu mgħaġġel ta' lacosamide b'doża għal ġol-vini singola kbira tal-bidu (inkluż 200 mg) segwita minn doża orali darbtejn kuljum (ekwivalenti għad-doża għal ġol-vini) bħala terapija aġġuntiva f'pazjenti adulti ta' 16 sa 60 sena b' aċċessjonijiet partial-onset.
English: It should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8).
Maltese: Għandha tingħata taħt superviżżjoni medika b'konsiderazzjoni għall-potenzjal ta' żieda fl-inċidenza ta' arritmija kardijaka serja u reazzjonijiet mhux mixtieqa tas-sistema nervuża ċentrali (ara s-sezzjoni 4.8).
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX18
Maltese: Kategorija farmakoterapewtika: mediċini ta' kontra l-epilessija, mediċini ta' kontra l-epilessija oħra, Kodiċi ATC:
English: Lacosamide UCB 200 mg are blue, oval film-coated tablets of approximately 16.6 mm x 7.8 mm with a debossed ‘SP' on one side and ‘200' on the other side.
Maltese: • Lacosamide UCB 200 mg huma blu, pilloli ovali miksija b'rita b'dimensjonijiet ta' madwar 16.6 mm x 7.8 mm, b'‘SP' imnaqqax fuq naħa waħda u ‘200' fuq in-naħa l-oħra.
English: Taking Lacosamide UCB on its own - This is for information only.
Maltese: Meta tuża Lacosamide UCB waħdu - Din hija għal skopijiet ta' informazzjoni biss.
English: Dosing oral syringe (10 ml graduated every 0.25 ml) with an adaptor (for children and adolescents from 4 years of age weighing less than 50 kg)
Maltese: Siringa tad-dożaġġ orali (10 ml gradwata kull 0.25 ml) b'adapter (għal tfal u adoloxxenti minn 4 snin ta' età li jiżnu inqas minn 50 kg)
English: The plasma concentration increases proportionally with dose after oral (100-800 mg) and intravenous (50-300 mg) administration.
Maltese: Il-konċentrazzjoni tal-plażma tiżdied proporzjonalment mad-doża war li jittieħed mill-ħalq (100-800 mg) u minn ġol-vina (50-300 mg).
English: Contusion (1) Adverse reactions reported in post marketing experience.
Maltese: Kontuzjoni (1) Reazzjonijiet avversi li ġew rapportati f'esperjenza ta' wara t-tqegħid fis-suq.
English: No clinically relevant difference in lacosamide exposure was observed comparing its pharmacokinetics in extensive metabolisers (EMs, with a functional CYP2C19) and poor metabolisers (PMs, lacking a functional CYP2C19).
Maltese: Ma kinitx osservata differenza klinikament relevanti fl-esponiment ta' lacosamide meta tqabbel il-farmakokinetika tiegħu f'metabolizzanti estensivi (EMs, b' CYP2C19 funzjonali) u lmetabolizzanti deboli (PMs, li m'għandhomx CYP2C19 funzjonali).
English: EU/1/19/1383/004 EU/1/19/1383/005 EU/1/19/1383/006 EU/1/19/1383/007 EU/1/19/1383/008 EU/1/19/1383/009
Maltese: EU/1/19/1383/005 EU/1/19/1383/006 EU/1/19/1383/007 EU/1/19/1383/008 EU/1/19/1383/009 EU/1/19/1383/010 EU/1/19/1383/011 EU/1/19/1383/012 EU/1/19/1383/013 EU/1/19/1383/014
English: 2 mg/kg/day
Maltese: 2 mg/kg/jum