FrancophonIA/ELRC3.0 huggingface dataset:
English: Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of lacosamide (approximately 50 % higher AUCnorm).
Maltese: Persuni b'indeboliment moderat tal-fwied (Child-Pugh B) wrew konċentrazzjoni ogħla ta' lacosamide fil-plażma (AUCnorm madwar 50 % ogħla).
English: Lacosamide is primarily eliminated from the systemic circulation by renal excretion and biotransformation.
Maltese: Lacosamide huwa eliminat primarjament miċ-ċirkulazzjoni sistemika b'eskrezzjoni renali u bijotrasformazzjoni.
English: Pruritus Rash(1)
Maltese: Ħakk Raxx(1)
English: 95 % of the dose is excreted in the urine as lacosamide and metabolites.
Maltese: 95% tad-doża hija mneħħija fl-awrina bħala lacosamide u prodott tal-metaboliżmu.
English: In children weighing less than 40 kg, a maximum dose of up to 12 mg/kg/day is recommended.
Maltese: Fi tfal li jiżnu inqas minn 40 kg, hija rrakkomandata doża massima sa 12 mg/kg/jum.
English: One tablet of Lacosamide UCB 150 mg contains 150 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide UCB 150 mg fiha 150 mg lacosamide.
English: Lacosamide is less than 15 % bound to plasma proteins.
Maltese: Lacosamide huwa marbut b' inqas minn 15 % malproteini fil-plażma.
English: Each ml of solution for infusion contains 2.99 mg sodium.
Maltese: Kull ml ta' soluzzjoni għall-infużjoni fih 2.99 mg sodju.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għal kondizzjonijiet għal-ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: 0.4 ml/kg (4 mg/kg) Maximum recommended dose
Maltese: 0.4 ml/kg (4 mg/kg) Doża massima rakkomandata
English: Stevens-Johnson syndrome(1) Toxic epidermal necrolysis(1)
Maltese: Sindromu ta' StevensJohnson(1)
English: In anesthetised dogs and Cynomolgus monkeys, at intravenous doses of 15-60 mg/kg, slowing of atrial and ventricular conductivity, atrioventricular block and atrioventricular dissociation were seen.
Maltese: F'dożi li jingħataw ġol-vina ta' 1560 mg/kg f'klieb anastetiżżati,u f'xadini Cynomolgus, kienu osservati kondittivita`atrijali u ventrikulari iżjed bil-mod, blokk atrijoventrikulari u dissoċjazzjoni.
English: An infusion duration of at least 30 minutes for administration > 200 mg per infusion (i.e. > 400 mg/day) is preferred.
Maltese: Tul talinfużjoni ta' mill-inqas 30 minuta għall-amministrazzjoni > 200 mg għal kull infużjoni (jiġifieri > 400 mg/jum) hija ppreferuta.
English: In children weighing from 20 to under 30 kg, a maximum dose of 10 mg/kg/day is recommended and in children weighing from 30 to under 50 kg, a maximum dose of 8 mg/kg/day is recommended, although in open-label studies (see sections 4.8 and 5.2), a dose up to 12 mg/kg/day has been used by a small number of these children.
Maltese: Fi tfal li jiżnu minn 20 sa inqas minn 30 kg, hija rrakkomandata doża massima ta' 10 mg/kg/jum u fi tfal li jiżnu minn 30 sa inqas minn 50 kg, hija rrakkomandata doża massima ta' 8 mg/kg/jum, għalkemm fi studji open-label (ara sezzjonijiet 4.8 u 5.2), intużat doża sa 12 mg/kg/jum minn numru żgħir ta' dawn it-tfal.
English: This was reported with lacosamide in 4.8 % (3/62) in elderly patients versus 1.6 % (6/382) in younger adult patients.
Maltese: Dan kien irrappurtat b'lacosamide f'4.8% (3/62) pazjenti anzjani versus 1.6% (6/382) f'pazjenti adulti iżgħar.
English: Although no pharmacokinetic data on the interaction of lacosamide with alcohol are available, a pharmacodynamic effect cannot be excluded.
Maltese: Għalkemm m'hemmx data farmakokinetika dwar l-interazzjoni ta'lacosamide flimkien ma' l'alkoħol, ma jistax jiġi eskluż effett farmakodinamiku.
English: • Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, seizures (generalised tonic-clonic seizures, status epilepticus).
Maltese: • Reazzjonijiet irrappurtati wara t-teħid ta' iżjed minn 800 mg kienu sturdament, dardir, rimettar, aċċessjonijiet ( aċċessjonijiet tat-tip tonic-clonic ġeneralizzat, staus epilepticus).
English: In post-marketing experience, AV block (including second degree or higher AV block) has been reported.
Maltese: Ġie rrappurtat AV blokk (inkluż tat-tieni grad jew AV blokk ogħla) fl-esperjenza ta' wara t-tqegħid fis-suq.
English: The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) was established in 3 multicenter, randomised, placebo-controlled clinical trials with a 12-week maintenance period.
Maltese: L-effikaċja ta' lacosamide bħala terapija aġġuntiva fid-dożi rrikkmandati (200 mg/ġurnata, 400 mg/ġurnata, 600 mg/ġurnata) kienet stabbilita fi tlett provi kliniċi, kontrollati mill-plaċebo, randomized u multiċentrali, b' perjodu ta' manteniment ta 12-il ġimgħa.
English: Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
Maltese: Sintomi osservati wara doża akbar aċċidentali jew intenzjonali kienu primarjament assoċjati massistemi tas-CNS u dik gastrointestinali.
English: In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of the maximum dose is recommended.
Maltese: F'pazjenti pedjatriċi li jiżnu inqas minn 50 kg b'indeboliment tal-kliewi sever (CLCR ≤ 30 ml/min) u f'dawk il-pazjenti b'marda renali tal-aħħar fażi, huwa rrakkomandat tnaqqis ta' 25 % tad-doża massima.
English: Adolescents and children weighing 50 kg or more and adults
Maltese: Adoloxxenti u tfal li jiżnu 50 kg jew aktar, u adulti
English: PHARMACEUTICAL FORM Solution for infusion.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-infużjoni.
English: Therefore, clinically relevant interactions with other medicinal products through competition for protein binding sites are considered unlikely.
Maltese: Għalhekk mhux probabli li jkun hemm effetti klinikament relevanti ma' prodotti mediċinali oħra permezz ta' kompetizzjoni għal postijiet fejn jeħlu l-protejini.
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR the extent of increase in PR interval was comparable between lacosamide and carbamazepine.
Maltese: F' prova klinika ta' monoterapija li tqabbel lacosamide ma' carbamazepine (CR), iż-żieda fl-interval PR kienet komparabbli bejn lacosamide u carbamazepine.
English: One tablet of Lacosamide UCB 200 mg contains 200 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide UCB 200 mg fiha 200 mg lacosamide.
English: In juvenile rats and dogs, the types of toxicity do not differ qualitatively from those observed in adult animals.
Maltese: F'firien ġuvenili u klieb, it-tipi ta' tossiċità m'humiex differenti mil-lat kwalitattiv minn dawk osservati f'annimali adulti.
English: The incidence rate for syncope reported in pooled adjunctive therapy clinical trials is uncommon and did not differ between lacosamide (n=944) treated epilepsy patients (0.1 %) and placebo (n=364) treated epilepsy patients (0.3 %).
Maltese: Ir-rata tal-inċidenza ta' sinkope rrappurtata f'provi kliniċi miġbura minn terapija aġġuntiva mhux komuni u ma kienitx differenti bejn pazjenti li jbagħtu b'epilessija (0.1%) trattati b'lacosamide (n=944) u dawk il-pazjenti b'epilessija (0.3%) trattati bil-plaċebo(n=364).
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 14-il pillola miksija
English: INFORMATION IN BRAILLE Lacosamide UCB 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lacosamide UCB 200 mg
English: 150 mg (1 tablet Lacosamide UCB 150 mg)
Maltese: 150 mg (pillola Lacosamide UCB 150 mg waħda)
English: Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment a reduction of 25% of the maximum dose should be applied.
Maltese: Abbażi ta' data fl-adulti, f'pazjenti pedjatriċi li jiżnu inqas minn 50 kg b'indeboliment tal-fwied moderat, għandu jiġi applikat tnaqqis ta' 25% tad-doża massima.
English: One full 10 ml oral syringe corresponds to 100 mg of lacosamide.
Maltese: Siringa orali waħda ta' 10 ml sħiħa tikkorrispondi għal 100 mg ta' lacosamide.
English: Lacosamide does not inhibit or induce CYP2C19 and CYP3A4 to a clinically relevant extent.
Maltese: Lacosamide ma jinhibixxix u ma jindottax CYP2C19 u CYP3A4 sa punt li huwa klinikament relevanti.
English: This will be until you reach a maintenance dose.
Maltese: Dan se jkun sakemm tilħaq id-doża ta' manteniment.
English: Lacosamide UCB 50 mg film-coated tablets: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132)
Maltese: Lacosamide UCB 50 mg pilloli miksijin b'rita: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132)
English: 14 film-coated tablets 14 x 1 film-coated tablet 28 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablet 168 film-coated tablets
Maltese: 14 pilloli miksija b'rita 14 x 1 pillola miksija b'rita 28 pilloli miksija b'rita 56 pilloli miksija b'rita 56 x 1 pillola miksija b'rita 168 pilloli miksija b'rita
English: 200 mg (1 tablet Lacosamide UCB 200 mg)
Maltese: 200 mg (pillola Lacosamide UCB 200 mg waħda)
English: PHARMACEUTICAL FORM AND CONTENTS 200 ml syrup with measuring cup and oral syringe
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 200 ml mistura bit-tazza ta' kejl u siringa orali
English: The CYP2C19 inhibitor omeprazole (40 mg once daily) did not give rise to a clinically significant change in lacosamide exposure.
Maltese: L-inhibitur ta' CYP2C19 omeprazole (40 mg darba kuljum) ma kellux effett klinikament sinifikanti fuq it-tibdil fl-esponiment ta' lacosamide.
English: CLINICAL PARTICULARS
Maltese: Terapija aġġuntiva
English: Lacosamide UCB solution for infusion can be administered intravenously without further dilution or can be diluted with sodium chloride 9 mg/ml (0.9 %) solution for injection, glucose 50 mg/ml (5 %) solution for injection or lactated Ringer's solution for injection.
Maltese: Lacosamide UCB soluzzjoni għallinfużjoni tista' tingħata ġol-vini mingħajr dilwizzjoni ulterjuri jew tista' tiġi dilwita b'sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjonisodium, glucose 50 mg/ml (5 %) soluzzjoni għall-injezzjoni jew soluzzjoni għall-injezzjoni Ringer.
English: Carton of 56 film-coated tablets 150 mg (without Blue Box)
Maltese: Pakkett ta' 56 pilloli miksija b'rita 150mg (mingħajr blue box)
English: 100 mg (1 tablet Lacosamide UCB 100 mg)
Maltese: 100 mg (pillola Lacosamide UCB 100 mg waħda)
English: Carton 14 tablets - week 1
Maltese: Pakkett 14-il-pillola - ġimgħa 1
English: When you take Lacosamide UCB with other antiepileptic medicines The usual starting dose of Lacosamide UCB is 50 mg (5 ml) twice a day.
Maltese: Meta tieħu Lacosamide UCB ma' mediċini ta' kontra l-epilessija oħra Id-doża tal-bidu ta' Lacosamide UCB li normalment tingħata hija ta' 50 mg (5 ml) darbtejn kuljum.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose ma għandhomx jieħdu din il-mediċina.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Maltese: DATA TA L-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni:
English: Lacosamide UCB 150 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
Maltese: Lacosamide UCB 150 mg pilloli miksijin b'rita polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
English: Lacosamide syrup is provided with a measuring cup with graduation marks (for patients weighing 50 kg or more) and with an oral syringe with an adaptor (for patients weighing less than 50 kg).
Maltese: Lacosamide mistura hija pprovduta b'tazza ta' kejl b'marki tal-gradwazzjoni (għal pazjenti li jiżnu 50 kg jew aktar) u b'siringa orali b'adapter (għal pazjenti li jiżnu inqas minn 50 kg).
English: Using Lacosamide UCB
Maltese: Tieħux Lacosamide UCB
English: In juvenile rats, a reduced body weight was observed at systemic exposure levels similar to the expected clinical exposure.
Maltese: esponiment sistemiku simili għall-esponiment kliniku mistenni.
English: This medicinal product contains 2.6 mmol (or 59.8 mg) sodium per vial.
Maltese: Dan il-prodott mediċinali fih 2.6 mmol (jew 59.8 mg) ta' sodju f'kull fjala.
English: Sodium chloride
Maltese: Ilma għall-injezzjonijiet Sodium chloride
English: Population pharmacokinetic analyses in different age groups estimated that concomitant treatment with other antiepileptic medicinal products known to be enzyme inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic exposure of lacosamide by 25 % in adults and 17 % in paediatric patients.
Maltese: Analiżi farmakokinetika tal-popolazzjoni fi gruppi ta' età differenti ħarġet stima li trattament flimkien ma' prodotti mediċinali ta' kontra l-epilessija oħra magħrufa li jindottaw l-enżimi (carbamazepine, phenytoin, phenobarbital, f'dożi varji) naqset l-esponiment sistemiku totali ta' lacosamide b'25 % fl-adulti u b'17 % fil-pazjenti pedjatriċi.
English: 50 mg twice a day (100 mg/day) at weekly intervals
Maltese: 50 mg darbtejn kuljum (100 mg/jum) f'intervalli filġimgħa
English: Carton of 56 film-coated tablets 200 mg (without Blue Box)
Maltese: Pakkett ta' 56 pilloli miksija b'rita 200mg (mingħajr blue box)
English: Lacosamide UCB 200 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) indigo carmine aluminium lake (E132)
Maltese: Lacosamide UCB 200 mg pilloli miksijin b'rita polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) indigo carmine aluminium lake (E132)
English: Lacosamide UCB 10 mg/ml syrup lacosamide
Maltese: Lacosamide UCB 10 mg/ml mistura lacosamide
English: Lacosamide UCB 100 mg are dark yellow, oval film-coated tablets of approximately 13.2 mm x 6.1 mm with a debossed ‘SP' on one side and ‘100' on the other side.
Maltese: • Lacosamide UCB 100 mg huma sofor skuri, pilloli ovali miksija b'rita, b'dimensjonijiet ta' madwar 13.2 mm x 6.1 mm b'‘SP' imnaqqxa fuq naħa waħda u ‘100' fuq in-naħa l-oħra.
English: The solution for infusion is infused over a period of 15 to 60 minutes twice a day.
Maltese: Is-soluzzjoni għall-infużjoni tiġi infuża fuq perjodu ta' 15 sa 60 minuta darbtejn kuljum.
English: 1 vial contains 20 ml Lacosamide UCB solution for infusion equivalent to 200 mg lacosamide.
Maltese: Fjala waħda fiha 20 ml Lacosamide UCB soluzzjoni għall-infużjoni ekwivalenti għal 200 mg lacosamide.
English: The patients were randomised to carbamazepine CR or lacosamide, provided as tablets, in a 1:1 ratio.
Maltese: Il-pazjenti kienu randomizzati għal carbamazepine CR jew lacosamide, provduti bħala pilloli, b' proporzjoni ta' 1:1.
English: 0.1 ml/kg (1 mg/kg) Starting dose
Maltese: 0.1 ml/kg (1 mg/kg) Doża talbidu
English: The oral bioavailability of lacosamide tablets is approximately 100 %.
Maltese: Ilbiodisponibilta` orali ta' lacosamide hija madwar 100%.
English: Breastfeeding
Maltese: Treddiegħ
English: Lacosamide plasma concentrations were not affected by carbamazepine and by valproic acid.
Maltese: Il-konċentrazzjoni filplażma ta' lacosamide ma kienx affetwat b'carbamazepine u valproic acid.
English: • Runny nose (nasopharyngitis);
Maltese: • Imnieħer inixxi (nażofarinġite);
English: Monotherapy doses to be taken twice daily for children and adolescents from 4 years of age weighing 40 kg to under 50 kg(1) (2):
Maltese: Dożi ta' monoterapija li għandhom jittieħdu darbtejn kuljum għal tfal u adoloxxenti minn 4 snin ta' età li jiżnu 40 kg sa inqas minn 50 kg(1) (2):
English: Nausea Vomiting Constipation Flatulence
Maltese: Nystagmus Ipoestesja Disartrija Disturbi flattenzjoni
English: The exposure of the O-desmethyl metabolite was several-fold increased in patients with moderate and severe renal impairment.
Maltese: L-esponiment tal -prodott tal-metaboliżmu O-desmethyl kien miżjud b'diversi drabi f'pazjenti b'indeboliment moderat jew sever.
English: Packs of 14, 28, 56 and 168 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Maltese: Pakketti ta' 14, 28, 56 u 168 pillola miksija b'rita f'folja tal-PVC/PVDC issiġillata b'fojl tal-aluminju.
English: In all of these controlled studies, the discontinuation rate due to adverse reactions was 12.2 % for patients randomised to lacosamide and 1.6 % for patients randomised to placebo.
Maltese: F' dawn l-istudji kollha, ir-rata ta' twaqqif minħabba l-effetti mhux mixtieqa kienet ta' 12.2% għal pazjenti li kienu randomised fuq lacosamide u 1.6% għal pazjenti randomised fuq il-plaċebo.
English: Lacosamide UCB 50 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) red iron oxide (E172) black iron oxide (E172) indigo carmine aluminium lake (E132)
Maltese: Lacosamide UCB 50 mg pilloli miksijin b'rita polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) red iron oxide (E172) black iron oxide (E172) indigo carmine aluminium lake (E132)
English: In this study, 425 patients aged 16 to 70 years with uncontrolled partial-onset seizures taking stable doses of 1 or 2 marketed antiepileptic medicinal products were randomised to be converted to lacosamide monotherapy (either 400 mg/day or 300 mg/day in a 3:1 ratio).
Maltese: F'dan l-istudju, 425 patients ta' 16 sa 70 sena t'eta` b' aċċessjonijiet tat-tip partial-onset mhux ikkontrollati li jieħdu dożi stabbli ta' 1 jew 2 prodotti mediċinali ta' kontra l-epilessija mqegħda fis-suq kienu randomizzati li jinbidlu fuq monoterapija b' lacosamide (jew 400 mg/ġurnata jew 300 mg/ġurnata f' proporzjon ta' 3:1).
English: Allergic reaction to medicine intake, hives;
Maltese: • Reazzjoni allerġika għal mediċina, ħorriqijia;
English: INFORMATION IN BRAILLE Lacosamide UCB 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lacosamide UCB 150 mg
English: One full oral syringe (10 ml) corresponds to 100 mg of lacosamide.
Maltese: Siringa waħda sħiħa orali (10 ml) tikkorrespondi għal 100 mg ta' lacosamide.
English: Each pack of 56 film-coated tablets for a 4-week treatment schedule contains: 14 film-coated tablets of Lacosamide UCB 50 mg 14 film-coated tablets of Lacosamide UCB 100 mg 14 film-coated tablets of Lacosamide UCB 150 mg 14 film-coated tablets of Lacosamide UCB 200 mg
Maltese: Kull pakkett ta' 56 pillola miksija b'rita għal skeda ta' trattament ta' 4 ġimgħat fiħ: 14 pilloli miksija b'rita ta' Lacosamide UCB 50 mg 14 pilloli miksija b'rita ta' Lacosamide UCB 100 mg 14 pilloli miksija b'rita ta' Lacosamide UCB 150 mg 14 pilloli miksija b'rita ta' Lacosamide UCB 200 mg
English: 14 film-coated tablets 14 x 1 film-coated tablet 28 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablet
Maltese: 14 pilloli miksija b'rita 14 x 1 pillola miksija b'rita 28 pilloli miksija b'rita 56 pilloli miksija b'rita 56 x 1 pillola miksija b'rita
English: The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see section 5.2).
Maltese: Ilfarmakokinetika ta' lacosamide ma ġietx evalwata f'pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 5.2).
English: In the monotherapy study comparing lacosamide to carbamazepine CR, the types of adverse reactions related to lacosamide in elderly patients (≥ 65 years of age) appear to be similar to that observed in patients less than 65 years of age.
Maltese: Fi studju b'monoterapija li jqabbel lacosamide ma' carbamazepine CR, it-tipi ta' reazzjonijiet avversi relatati ma' lacosamide f'pazjenti anzjani (≥ 65 sena t'età) jidhru li huma simili għal dawk osservati f'pazjenti t'inqas minn 65 sena.
English: Strong enzyme inducers such as rifampicin or St John's wort (Hypericum perforatum) may moderately reduce the systemic exposure of lacosamide.
Maltese: Mediċini li jindottaw l-enzimi b'mod b'saħħtu bħal rifampicin u St John's Wort (Hypericum perforatum) jistgħu jnaqqsu moderatament l-esponiment sistemiku ta' lacosamide.
English: 50 mg (1tablet Lacosamide UCB 50 mg)
Maltese: 50 mg (pillola Lacosamide UCB 50 mg waħda)
English: Overall, the proportion of subjects with at least a 50 % reduction in partial-onset seizure frequency per 28 days from baseline to the maintenance period was 52.9 % in the lacosamide group compared with 33.3 % in the placebo group.
Maltese: B'mod ġenerali, l-proporzjon ta' pazjenti li kellhom mill-inqas tnaqqis ta' 50 % fil-frekwenza ta' feġġa parzjali ta' aċċessjoni f'28 jum mill-linja bażi għall-perjodu ta' manteniment kien ta' 52.9 % filgrupp tal-lacosamide meta mqabbel għal 33.3 % fil-grupp tal-plaċebo.
English: An in vitro study indicated that lacosamide is not transported by P-glycoprotein in the intestine.
Maltese: Studju in-vitro jindika li lacosamide ma jiġiex trasportat minn P-glycoprotein fl-imsaren.
English: Clinical trials indicate that gender does not have a clinically significant influence on the plasma concentrations of lacosamide.
Maltese: Provi kliniċi juru li s-sess m'għandux influenza klinikament sinifikanti fuq konċentrazzjoni fil-plażma ta' lacosamide.
English: Lacosamide UCB 100 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172)
Maltese: Lacosamide UCB 100 mg pilloli miksijin b'rita polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172)
English: Packs of 14 x 1 and 56 x 1 film-coated tablet in PVC/PVDC perforated unit dose blisters sealed with an aluminium foil.
Maltese: Pakketti ta 14 x 1 u 56 x 1 pillola miksija b'rita f' folji tal-PVC/PVDC li jistgħu jinqasmu f'dożi singoli siġillata b'fojl tal-aluminju.
English: Lacosamide UCB with alcohol As a safety precaution do not take Lacosamide UCB with alcohol.
Maltese: Lacosamide UCB ma' ikel, xorb u alkoħol Bħala prekawzjoni ta' sigurtà tieħux Lacosamide UCB ma' l-alkoħol.
English: In the placebo-controlled trials of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however, both have been reported in open-label epilepsy trials and in post-marketing experience.
Maltese: Ma ġewx irrappurtati fibrillazzjoni jew taħbit atrijali rregolari fi provi kliniċi ta' medda qasira; iżda ttnejn ġew irrappurtati fi provi open-label tal-epilessija u fl-esperjenza ta' wara t-tqegħid fis-suq.
English: 1 vial of 20 ml contains 200 mg lacosamide.
Maltese: Fjala waħda ta' 20 ml fih 200 mg lacosamide.
English: Blue, oval film-coated tablets with approximate dimensions of 16.6 mm x 7.8 mm, and debossed with ‘SP' on one side and ‘200' on the other side.
Maltese: Pilloli miksija b'rita ovali, blu, b'dimensjonijiet ta' madwar 16.6 mm x 7.8 mm, u mnaqqxin b'‘SP' imnaqqax fuq naħa waħda u ‘200' fuq in-naħa l-oħra.
English: INFORMATION IN BRAILLE Lacosamide UCB 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lacosamide UCB 100 mg
English: One tablet of Lacosamide UCB 50 mg contains 50 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide UCB 50 mg fiha 50 mg lacosamide.
English: Swallow the Lacosamide UCB tablet with a glass of water.
Maltese: • Ibla' l-pillola Lacosamide UCB b'tazza ilma.
English: The 14 x 1 and 56 x 1 film-coated tablet packs are available as perforated unit dose PVC/PVDC blisters sealed with an aluminium foil, all other packs are available with standard PVC/PVDC blisters sealed with an aluminium foil.
Maltese: Il-pakkett ta' 14 x 1 u 56 x 1 pilloli miksija b'rita ssibhom f'folji tal PVC/PVDC li jistgħu jinqasmu f'dożi singoli siġillata b'fojl tal-aluminju, ilpakketti l-oħra kollha ssibhom f'folji standard tal-PVC/PVDC siġillata b'fojl tal-aluminju.
English: This will be until you reach a maintenance dose of between 100 mg and 200 mg twice a day.
Maltese: Dan se jkun sakemm tilħaq id-doża ta' manteniment ta' bejn 100 mg u 200 mg darbtejn kuljum.
English: The plasma concentration of O-desmethyl-lacosamide is approximately 15 % of the concentration of lacosamide in plasma.
Maltese: Ilkonċentrazzjoni tal-plażma ta' O-desmethyl-lacosamide huwa madwar 15% tal-konċentrazzjoni ta' lacosamide fil-plażma.