FrancophonIA/ELRC3.0 huggingface dataset:
English: In all of these controlled studies, the discontinuation rate due to adverse reactions was 12.2 % for patients randomized to lacosamide and 1.6 % for patients randomized 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 ilplaċebo.
English: The patients were randomized 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: Risk related to epilepsy and antiepileptic medicinal products in general
Maltese: Ir-riskju ġeneralment relatat ma' l-epilessija u ma' prodotti mediċinali ta' kontra l-epilessija
English: Each pack of 56 film-coated tablets for a 4-week treatment schedule contains: 14 film-coated tablets of Lacosamide Accord 50 mg 14 film-coated tablets of Lacosamide Accord 100 mg 14 film-coated tablets of Lacosamide Accord 150 mg 14 film-coated tablets of Lacosamide Accord 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 Accord 50 mg 14 pilloli miksija b'rita ta' Lacosamide Accord 100 mg 14 pilloli miksija b'rita ta' Lacosamide Accord 150 mg 14 pilloli miksija b'rita ta' Lacosamide Accord 200 mg
English: Packs of 14 x 1 or 56 x 1 tablet in perforated unit dose blisters Not all pack sizes may be marketed.
Maltese: Pakketti ta 14 x 1 jew 56 x 1 pillola f'folji li jistgħu jinqasmu f'dożi singoli.
English: Lacosamide Accord contains soya lecithin.
Maltese: Lacosamide Accord fih il-leċitina tas-sojja.
English: Carton 14 tablets - week 2
Maltese: Pakkett 14-il pillola - ġimgħa 2
English: EU/1/17/1230/005 EU/1/17/1230/006 EU/1/17/1230/007 EU/1/17/1230/008 EU/1/17/1230/019 EU/1/17/1230/020
Maltese: EU/1/17/1230/006 EU/1/17/1230/007 EU/1/17/1230/008 EU/1/17/1230/019 EU/1/17/1230/020
English: Bradycardia(1,2) Atrial Fibrillation Atrial Flutter (1,2)
Maltese: Fibrillazzjoni atrijali(1,2)
English: This will be until you reach a maintenance dose 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: Lacosamide Accord 200 mg film coated tablets: EU/1/17/1230/013-016
Maltese: Lacosamide Accord 200 mg pilloli miksija b'rita EU/1/17/1230/013-016
English: Blister label - week 4
Maltese: Tfal iżgħar minn 4 snin
English: Lacosamide Accord may make you dizzy- this could increase the risk of accidental injury or a fall.
Maltese: Lacosamide Accord jista' jistordik - dan jista' jżid ir-riskju ta' korriment jew waqgħat.
English: One tablet of Lacosamide Accord 150 mg contains 150 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide Accord 150 mg fiha 150 mg lacosamide.
English: In a study in elderly men and women including 4 patients > 75 years of age, AUC was about 30 and 50 % increased compared to young men, respectively.
Maltese: F'studji fl-anzjani, irġiel u nisa inkluż 4 pazjenti > 75 sena, AUC kien rispettivament madwar 30 u 50% ogħla meta mqabbla ma' dak f'irġiel ta' eta żgħira.
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: The other ingredients are:
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq:
English: One tablet of Lacosamide Accord 50 mg contains 50 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide Accord 50 mg fiha 50 mg lacosamide.
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 randomized to be converted to lacosamide monotherapy (either 400mg/day or 300mg/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 400mg/ġurnata jew 300mg/ġurnata f' proporzjon ta' 3:1).
English: MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Accord Healthcare S.L.U.
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172) Indigo carmine aluminum lake (E132) Lecithin (soya)
Maltese: Iron oxide black (E172) Indigo carmine aluminum lake (E132) Leċitina (sojja)
English: One tablet of Lacosamide Accord 200 mg contains 200 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide Accord200 mg fiha 200 mg lacosamide.
English: Carton 14 tablets - week 3
Maltese: Pakkett 14-il pillola - ġimgħa 3
English: Lacosamide Accord 150 mg film coated tablets: EU/1/17/1230/009-012
Maltese: Lacosamide Accord 150 mg pilloli miksija b'rita EU/1/17/1230/009-012
English: Lacosamide Accord 100 mg film coated tablets: EU/1/17/1230/005-008
Maltese: Lacosamide Accord 100 mg pilloli miksija b'rita EU/1/17/1230/005-008
English: This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day.
Maltese: Dan ikun sakemm tilħaq id-doża ta' manteniment bejn 100 mg u 300 mg darbtejn kuljum.
English: What Lacosamide Accord contains The active substance is lacosamide.
Maltese: • Is-sustanza attiva hi lacosamide.
English: Pink, oval, approximately 10.3 x 4.8 mm, coated tablets, debossed “L” on one side and “50” on other side.
Maltese: Pilloli miksija b'rita roża, ovali, madwar 10.3 x 4.8 mm, b'“L” imnaqqxa fuq naħa waħda u “50” fuq in-naħa l-oħra.
English: The paediatric pharmacokinetic profile of lacosamide was determined in a population pharmacokinetic analysis using sparse plasma concentration data obtained in one placebo-controlled randomised study and three open-label studies in 414 children with epilepsy aged 6 months to 17 years.
Maltese: Il-profil farmakokinetiku pedjatriku ta' lacosamide ġie stabbilit f'analiżi farmakokinetika talpopolazzjoni permezz ta' dejta dwar il-konċentrazzjoni tal-plasma miksuba fi studju randomizzat ikkontrollat bil-plaċebo u tliet studji open-label f'414 tifel/tifla b'epilessija ta' bejn 6 xhur u 17-il sena.
English: Lacosamide Accord 100 mg are dark yellow, oval, approximately 13.0 x 6.0 mm, coated tablets, debossed “L” on one side and “100” on other side.
Maltese: Lacosamide Accord 100 mg huma pilloli miksija b'rita sofor skuri, ovali, madwar 13.0 x 6.0 mm, b'“L” imnaqqxa fuq naħa waħda u “100” fuq in-naħa l-oħra.
English: Lacosamide Accord is indicated as monotherapy and adjunctive therapy in the treatment of partialonset seizures with or without secondary generalisation in adolescents and children from 4 years of age weighing 50 kg or more and in adults with epilepsy.
Maltese: Lacosamide Accord huwa indikat bħala monoterapija u terapija miżjuda fit-trattament ta' aċċessjonijiet tat-tip ‘partial-onset' kemm b'ġeneralizzazzjoni sekondarja kif ukoll mingħajr, f'adulti, adoloxxenti u tfal mill-età ta' 4 snin b'epilessija.
English: One tablet of Lacosamide Accord 100 mg contains 100 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide Accord 100 mg fiha 100 mg lacosamide.
English: Nystagmus
Maltese: Sturdament
English: • medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
Maltese: • mediċini li jistgħu jżidu l-“intervall PR” fuq skan tal-qalb (ECG jew elektrokardjogramma) bħal mediċini għall-epilessija jew l-uġigħ li jissejħu carbamazepine, lamotrigine jew pregabalin;
English: The administered lacosamide doses ranged from 2 to 17.8 mg/kg/day in twice daily intake, with a maximum of 600 mg/day for children weighing 50 kg or more.
Maltese: Id-dożi amministrati ta' lacosamide varjaw minn 2 sa 17.8 mg/kg/jum f'teħid darbtejn kuljum, b'massimu ta' 600 mg/jum għal tfal li jiżnu aktar minn 50 kg.
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: F'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: Lacosamide Accord 50 mg film coated tablets: EU/1/17/1230/001-004
Maltese: Lacosamide Accord 50 mg pilloli miksija b'rita EU/1/17/1230/001-004
English: Hypersensitivity to the active substance, soya lecithin or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal-leċitina tas-sojja jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Other medicines and Lacosamide Accord
Maltese: Kif tieħu Lacosamide Accord
English: Liver function test abnormal (2)
Maltese: Testijiet talfunzjoni tal-fwied mhux normali(2)
English: Taking Lacosamide Accord
Maltese: X'inhu Lacosamide Accord
English: In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but an increase in numbers of stillborn pups and pup deaths in the peripartum period, and slightly reduced live litter sizes and pup body weights were observed at maternal toxic doses in rats corresponding to systemic exposure levels similar to the expected clinical exposure.
Maltese: F'studji dwar l-effett tossiku fuq is-sistema riproduttiva u l-iżvillup f' annimali gerriema u ġrieden, ma kienux osservati effetti teratoġeniċi imma kien hemm żieda fin-numru ta' frieħ li twieldu mejta u mwiet ta' frieħ fil-perjodu ta' wara t-twelid u tnaqqis żgħir ħafna fid-daqs tal-boton u fil-piz tal-frieħ b'dożi tossiċi fl-omm fil-firien li jikkorrespondu għal livelli ta' esponiment sistemiċi simili għal esponiment kliniku mistenni.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lacosamide.
Maltese: Il-mekkaniżmu ta' dan ir-riskju mhux magħruf u d-dejta preżenti ma teskludix il-possibilta` ta' żieda fir-riskju b' lacosamide.
English: Based on the analysis of data from a non-inferiority monotherapy clinical trial comparing lacosamide to carbamazepine controlled release (CR), the most frequently reported adverse reactions (≥10 %) for lacosamide were headache and dizziness.
Maltese: Ibbażat fuq l-analiżi ta' dejta minn prova klinika ta' monoterapija mhux inferjuri li tqabbel lacosamide ma' carbamazepine relaxx ikkontrollat (CR), l-iżjed reazzjonijiet avversi rapportati frekwentament (≥10%) għal lacosamide kienu uġiegħ ta' ras u sturdament.
English: Eligible patients on a stable dose regimen of 1 to ≤ 3 antiepileptic medicinal products, who still experienced at least 2 partial-onset seizures during the 4 weeks prior to screening with seizure-free phase no longer than 21 days in the 8-week period prior to entry into the baseline period, were randomised to receive either placebo (n=172) or lacosamide (n=171).
Maltese: Il-pazjenti eliġibbli fuq reġim ta' dożaġġ stabbli ta' bejn 1 u ≤ 3 prodotti mediċinali antiepilettiċi, li esperjenzaw mill-inqas żewġ aċċessjonijiet b'feġġa parzjali matul 1-4 ġimgħat ta' qabel l-eżami b'fażi mingħajr aċċessjonijiet mhux itwal minn 21 jum fil-perjodu ta' 8 ġimgħat qabel id-dħul fil-perjodu ta' linja bażi, ġew randomizzati biex jirċievu jew plaċebo (n=172) jew lacosamide (n=171).
English: Blue, oval, approximately 16.4 x 7.6 mm, coated tablets, debossed “L” on one side and “200” on other side.
Maltese: x 7.6 mm, b'“L” imnaqqxa fuq naħa waħda u “200” fuq in-naħa l-oħra.
English: Flatulence Dyspepsia Dry mouth Diarrhoea
Maltese: Nystagmus Ipoestesja Disartrija Disturbi flattenzjoni Paraestesja
English: In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite but the main contributing isoenzyme has not been confirmed in vivo.
Maltese: Dejta in vitro juri li CYP2C9,CYP2C19 u CYP3A4 jistgħu jikkatalizzaw il-formazzjoni tal-prodott tal-metaboliżmu O- desmethyl iżda l-isoenzyme li prinċiparjament jieħu sehem ma ġiex ikkonfermat in vivo.
English: EU/1/17/1230/009 EU/1/17/1230/010 EU/1/17/1230/011 EU/1/17/1230/012 EU/1/17/1230/021 EU/1/17/1230/022
Maltese: EU/1/17/1230/011 EU/1/17/1230/012 EU/1/17/1230/021 EU/1/17/1230/022
English: Lacosamide Accord 50 mg Lacosamide Accord 100 mg Lacosamide Accord 150 mg Lacosamide Accord 200 mg film-coated tablets lacosamide
Maltese: Lacosamide Accord 50 mg Lacosamide Accord 100 mg Lacosamide Accord 150 mg Lacosamide Accord 200 mg pilloli miksija b'rita lacosamide
English: In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes.
Maltese: Studji in vitro elettrofiżjoloġiċi wrew li lacosamide jinkoraġġixxi selettivament l-inattivazzjoni bilmod tal-kanali voltage-gated tas-sodju, li jirrisulta fl-istabilta` tal-membrani newronali ipereċċitabbli.
English: Based on the analysis of pooled placebo-controlled clinical trials in adjunctive therapy in 1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomized to lacosamide and 35.2 % of patients randomized to placebo reported at least 1 adverse reaction.
Maltese: Skond l-analiżi ta' provi kliniċi ikkontrollati bil-plaċebo dwar terapija aġġuntiva miġbura minn 1,308 pazjent b' aċċessjonijiet tat-tip partial-onset, total ta' 61.9% tal-pazjenti magħżula bl-addoċċ biex jieħdu lacosamide u 35.2% tal-pazjenti magħżula bl-addoċċ biex jieħdu l-plaċebo irrappurtaw millinqas reazzjoni mhux mixtieq wieħed.
English: Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day).
Maltese: Skond ir-rispons u t-tolerabbilta¦, id-doża ta' manteniment tista' tiżdied aktar f'intervalli ta' ġimgħa b' 50 mg darbtejn kuljum (100 mg/ġurnata), sa doża massima rikkmandata ta' 300 mg darbtejn kuljum (600 mg/kuljum).
English: After oral and intravenous administration of radiolabeled lacosamide, approximately 95% of radioactivity administered was recovered in the urine and less than 0.5% in the faeces.
Maltese: Wara t-teħid orali u minn ġol-vina ta' lacosamide radjutikkettat, madwar 95% tarradju-attivita` li ngħatat kienet misjuba fl-awrina u inqas minn 0.5% fl-ippurgar.
English: There is limited clinical data in the elderly patients with epilepsy, particularly at doses greater than 400 mg/day (see sections 4.4, 4.8, and 5.1).
Maltese: Hemm dejta klinika limitata f' anzjani partikolarment f'dożi akbar minn 400 mg/ġurnata (ara sezzjonijiet 4,4.
English: A maximum dose of 250 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease.
Maltese: Doża massima ta' 250 mg/ġurnata hija rrakkomandata għal pazjenti pedjatriċi li jiżnu 50 kg jew aktar u f'pazjenti adulti b'indeboliment sever tal-kliewi (CLCR ≤30 ml/min) jew b'mard tal-kliewi fl-aħħar fażi u trid tittieħed attenzjoni meta tiġi titrata d-doża.
English: The plasma concentration of O-desmethyl-lacosamide is approximately 15 % of the concentration of lacosamide in plasma.
Maltese: Il-konċentrazzjoni tal-plażma ta' O-desmethyl-lacosamide huwa madwar 15% tal-konċentrazzjoni ta' lacosamide fil-plażma.
English: In anesthetized 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: Dawn it-tibdiliet li jgħaddu bdew fl-istess medda ta' konċentrazzjoni wara d-dożaġġ massimu kliniku rrikkmandat .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: Lacosamide Accord treatment initiation pack contains 4 different packages (one for each tablet strength) with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient´s response and tolerability.
Maltese: Il-pakkett tal-bidu tat-trattament Lacosamide Accord fih 4 pakketti differenti ( wieħed għal kull pillola ta' saħħa differenti) b'14 il-pillola kull wieħed, għall-ewwel 2 sa 4 ġimgħat ta' terapija skond irrispons u t-tollerabbilta` tal-pazjent.
English: Tablet core
Maltese: LABORATORI FUNDACIÓ
English: Lacosamide Accord 150 mg film-coated tablets lacosamide
Maltese: Lacosamide Accord 150 mg pilloli miksija b'rita lacosamide
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products.
Maltese: Sensittivita' eċċessiva f' organi multipli (bħal Reazzjoni tal-mediċina b'Esinofilja u Sintomi sistemiċi, DRESS) kienu rrapportati f'pazjenti trattati b'xi prodotti mediċinali ta' kontra l-epilessija.
English: Salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed “L” on one side and “150” on other side.
Maltese: x 6.9 mm, b' “L” imnaqqxa fuq naħa waħda u “150” fuq in-naħa l-oħra.
English: (2) See Description of selected adverse reactions.
Maltese: (1) Reazzjonijiet avversi li ġew rapportati f'esperjenza ta' wara t-tqegħid fis-suq.
English: Dark yellow, oval, approximately 13.0 x 6.0 mm, coated tablets, debossed “L” on one side and “100” on other side.
Maltese: Pilloli miksija b'rita sofor skuri, ovali, madwar 13.0 x 6.0 mm, b' “L” imnaqqxa fuq naħa waħda u “100” fuq in-naħa l-oħra.
English: In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported.
Maltese: Dan il-prodott mediċinali fih il-leċitina (sojja).
English: EU/1/17/1230/013 EU/1/17/1230/014 EU/1/17/1230/015 EU/1/17/1230/016 EU/1/17/1230/023 EU/1/17/1230/024
Maltese: EU/1/17/1230/016 EU/1/17/1230/023 EU/1/17/1230/024
English: EU/1/17/1230/001 EU/1/17/1230/002 EU/1/17/1230/003 EU/1/17/1230/004 EU/1/17/1230/017 EU/1/17/1230/018
Maltese: EU/1/17/1230/001 EU/1/17/1230/002 EU/1/17/1230/003 EU/1/17/1230/004
English: No adverse reactions on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the maximum recommended human dose (MRHD).
Maltese: L-ebda effetti avversi fuq il-fertilit à `maskili jew feminili jew ir-riproduzzjoni fil-firien ġew osservati b'dożi li jipproduċu espożizzjonijiet fil-plażma (AUC) sa madwar darbtejn l-AUC tal-plażma filbniedem bid-doża massima rrikkmandata fil-bniedem (MRHD).
English: If you are taking Lacosamide Accord and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).
Maltese: Jekk qed tieħu Lacosamide Accord u qed tesperjenza sintomi ta' taħbit tal-qalb mhux normali (bħal taħbit tal-qalb bil-mod, mgħaġġel jew irregolari, palpitazzjonijiet, qtugħ ta' nifs, tħossok sturdut/a, ħass ħażin) fittex parir mediku immedjatament (ara sezzjoni 4).
English: Lacosamide Accord 200 mg film-coated tablets lacosamide
Maltese: Lacosamide Accord 200 mg pilloli miksija b'rita lacosamide
English: Lacosamide Accord 200 mg 1 film-coated tablet contains 200 mg lacosamide.
Maltese: Pillola waħda ta' Lacosamide Accord 200 mg fiha 200 mg lacosamide.
English: Lacosamide Accord 50 mg film-coated tablets lacosamide
Maltese: Lacosamide Accord 50 mg pilloli miksija b'rita Lacosamide
English: Week 3
Maltese: Ġimgħa 3
English: NAME OF THE MEDICINAL PRODUCT Lacosamide Accord 150 mg film-coated tablets lacosamide
Maltese: IL-PRODOTT MEDIĊINALI Lacosamide Accord 150 mg pilloli miksija b'rita lacosamide
English: Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia); A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Maltese: Raxx estiż bi bżieżaq u b'ġilda li titqaxxar, partikolarment madwar il-ħalq, imnieħer, għajnejn u ġenitali (Sindromu ta' Stevens-Johnson) u forma aktar severa ta'tqaxxir tal-ġilda f'iżjed minn 30% tal-wiċċ tal-ġilda (nekroliżi tossiku epidermali);
English: NAME OF THE MEDICINAL PRODUCT Lacosamide Accord 50 mg film-coated tablets lacosamide
Maltese: IL-PRODOTT MEDIĊINALI Lacosamide Accord 50 mg pilloli miksija b'rita lacosamide
English: In paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤30 ml/min) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed with caution.
Maltese: F'pazjenti pedjatriċi li jiżnu 50 kg jew iktar u għal pazjenti adulti b'indeboliment sever tal-kliewi (CLCR ≤30 ml/min) jew b'marda renali tal-aħħar fażi, hija rrakkomandata doża massima ta' 250 mg/kuljum.
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' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The most frequently reported adverse reactions (≥10 %) with lacosamide treatment were dizziness, headache, nausea and diplopia.
Maltese: L-iżjed effett mhux mixtieq li ġie rappurtat (≥10%) b'lacosamide kienu sturdament, uġigħ ta' ras, dardir u diplowpja.
English: When you take Lacosamide Accord with other antiepileptic medicines The usual starting dose of Lacosamide Accord is 50 mg twice a day.
Maltese: Meta tieħu Lacosamide Accord ma' mediċini ta' kontra l-epilessija oħra Id-doża tal-bidu ta' Lacosamide Accord li normalment tingħata hija ta' 50 mg darbtejn kuljum.
English: Paediatric population Adolescents and children weighing 50 kg or more
Maltese: Popolazzjoni pedjatrika Adoloxxenti u tfal li jiżnu 50 kg jew aktar
English: The exposure of the O-desmethyl metabolite was several-fold increased in patients with moderate and severe renal impairment.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Drug hypersensitivity(1)
Maltese: Nekroliżi tossika epidermali(1)
English: In an interaction trial there was no clinically relevant interaction between lacosamide and the oral contraceptives ethinylestradiol and levonorgestrel.
Maltese: Provi dwar l-effett ta' mediċini fuq l-effett farmaċewtiku tal-prodott wrew li ma kien hemm ebda effett klinikament rilevanti bejn lacosamide u l-kontraċettivi orali ethinylestradiol u levonorgestrel.
English: Fainting.
Maltese: Immaniġjar
English: However, a higher incidence (≥5 % difference) of fall, diarrhoea and tremor has been reported in elderly patients compared to younger adult patients.
Maltese: Madanakollu, inċidenza akbar (≥5% differenza) ta' waqgħa, dijarea u rogħda kien rappurtat f'pazjenti anzjani meta mqabbla ma' pazjenti adulti iżgħar.
English: Lacosamide Accord 100 mg film-coated tablets lacosamide
Maltese: Lacosamide Accord 100 mg pilloli miksija b'rita lacosamide
English: Muscle spasms
Maltese: Microcrystalline cellulose
English: Lacosamide Accord 50 mg film-coated tablets
Maltese: Lacosamide Accord 50 mg pilloli miksija b'rita