FrancophonIA/ELRC3.0 huggingface dataset:
English: Nervous system side effects such as dizziness may be higher after a single “loading” dose.
Danish: Bivirkninger fra nervesystemet, såsom svimmelhed, kan være højere efter en enkelt støddosis.
English: Adolescents and children weighing 50 kg or more Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above).
Danish: Unge og børn på 50 kg eller derover Dosering hos unge og børn på 50 kg eller derover er den samme som hos voksne (se ovenfor).
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.
Danish: Lacosamide UCB fås i pakninger med 14, 28, 56, 14 x 1 og 56 x 1 filmovertrukne tabletter samt i multipakninger indeholdende 3 pakninger á 56 tabletter.
English: Lacosamide UCB is available in a bottle of 200 ml.
Danish: • Lacosamide UCB fås i en flaske med 200 ml.
English: Lacosamide UCB may make you dizzy - this could increase the risk of accidental injury or a fall.
Danish: Lacosamide UCB kan medføre svimmelhed, der vil kunne øge risikoen for tilskadekomst eller fald.
English: Lacosamide syrup must be taken orally.
Danish: Lacosamid syrup er til oral anvendelse.
English: The oral syringe is suitable for children and adolescents below 50 kg. One full 10 ml oral syringe corresponds to 100 mg of lacosamide.
Danish: • Den orale sprøjte er egnet til børn og unge under 50 kg. En fuld 10 ml oral sprøjte svarer til 100 mg lacosamid.
English: Sore throat (pharyngitis);
Danish: • Ondt i halsen (pharyngitis);
English: You will start your treatment with a low dose of Lacosamide UCB, usually 50 mg twice a day, and increase it week by week.
Danish: De starter behandlingen med en lav dosis Lacosamide UCB, almindeligvis 50 mg 2 gange dagligt, og dosis øges uge efter uge.
English: Thus, the 600 mg/day dose is not recommended.
Danish: Derfor bør en daglig dosis på 600 mg ikke anvendes.
English: Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Danish: • Problemer med at holde balancen, rysten (tremor), prikkende og stikkende fornemmelse i huden (paræstesi) eller muskelspasmer, falder let og får blå mærker;
English: Conversion to monotherapy
Danish: Konvertering til monoterapi
English: Dizziness Headache
Danish: Svimmelhed Hovedpine
English: Children (from 4 years of age) and adolescents weighing less than 50 kg The dose is determined based on body weight.
Danish: Børn (fra 4 år) og unge, der vejer mindre end 50 kg Dosis bestemmes ud fra kropsvægt.
English: Also, it is not known whether Lacosamide UCB passes into the breast milk.
Danish: Det vides heller ikke, om Lacosamide UCB går over i modermælken.
English: PHARMACEUTICAL FORM AND CONTENTS 200 ml syrup with measuring cup and oral syringe
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 200 ml syrup med målebæger og oral sprøjte
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: Dato for seneste fornyelse:
English: Subjects must have achieved the minimum target dose for their body weight category for the final 3 days of the titration period to be eligible for entry into the 10-week maintenance period.
Danish: Forsøgspersonerne skal have opnået minimums-måldosen for deres kropsvægtkategori for de sidste 3 dage i titreringsperioden for at være egnede til at gå videre til den 10 ugers vedligeholdelsesperiode.
English: Lacosamide UCB syrup contains sodium methyl parahydroxybenzoate (E219), which may cause allergic reactions (possibly delayed).
Danish: Lacosamide UCB-syrup indeholder natriummethylparahydroxybenzoat (E 219), der kan give allergiske reaktioner (kan optræde efter behandlingen).
English: In post-marketing experience, AV block (including second degree or higher AV block) has been reported.
Danish: AV-blok (herunder AV-blok af 2. grad eller højere) er blevet rapporteret efter markedsføring.
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 randomised to lacosamide and 35.2 % of patients randomised to placebo reported at least 1 adverse reaction.
Danish: Baseret på analysen af puljede placebo-kontrollerede kliniske studier med tillægsbehandling, omfattende 1.308 patienter med fokale anfald, fandt man, at i alt 61,9 % af patienterne, der blev randomiseret til behandling med lacosamid, og 35,2 % af patienterne, der blev randomiseret til behandling med placebo, rapporterede mindst 1 bivirkning.
English: Atrial fibrillation or flutter were not reported in short term clinical trials; however, both have been reported in open-label epilepsy trials and in post-marketing experience.
Danish: Der blev ikke rapporteret atrieflimren eller atrieflagren i kortvarige kliniske studier; begge dele er dog blevet rapporteret fra ikke-blindede epilepsistudier og efter markedsføring.
English: Lacosamide plasma concentrations were not affected by carbamazepine and by valproic acid.
Danish: Plasmakoncentrationen af lacosamid blev ikke påvirket af carbamazapin eller valproinsyre.
English: Lacosamide must be taken twice a day (usually once in the morning and once in the evening).
Danish: Lacosamid skal tages to gange daglig (sædvanligvis én gang om morgenen og én gang om aftenen).
English: Agranulocytosis(1)
Danish: Agranulocytose(1)
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.
Danish: I de placebokontrollerede studier med lacosamid til epilepsipatienter blev der ikke rapporteret om atrieflimren eller atrieflagren; begge dele er dog rapporteret fra ikke-blindede epilepsistudier og efter markedsføring.
English: The other ingredients are: sodium chloride, hydrochloric acid, water for injections.
Danish: • Øvrige indholdsstoffer: Natriumchlorid, saltsyre, vand til injektionsvæsker.
English: LIST OF EXCIPIENTS Contains sodium chloride, hydrochloric acid, water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder natriumchlorid, saltsyre, vand til injektionsvæsker.
English: Each ml of solution for infusion contains 2.99 mg sodium.
Danish: Hver ml infusionsvæske, opløsning indeholder 2,99 mg natrium.
English: The precise volume of syrup is to be calculated according to the exact body weight of the child.
Danish: Den præcise mængde syrup skal beregnes i overensstemmelse med barnets nøjagtige kropsvægt.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Danish: Hvis De ikke er sikker, skal De tale med Lægen eller apotekspersonalet før De tager dette lægemiddel.
English: Lacosamide does not inhibit or induce CYP2C19 and CYP3A4 to a clinically relevant extent.
Danish: Lacosamid hverken hæmmer eller inducerer CYP2C19 og CYP3A4 i klinisk relevant grad.
English: The AUC of lacosamide was increased by approximately 30 % in mildly and moderately and 60 % in severely renal impaired patients and patients with end-stage renal disease requiring haemodialysis compared to healthy subjects, whereas Cmax was unaffected.
Danish: I forhold til raske personer steg lacosamids AUC med ca. 30 % hos patienter med mild til moderat nedsat nyrefunktion og 60 % hos patienter med alvorligt nedsat nyrefunktion samt hæmodialysekrævende patienter med nyresygdom i slutstadiet, mens Cmax var upåvirket.
English: The active substance is lacosamide.
Danish: • Aktivt stof: Lacosamid.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for product mixed with these diluents and stored in glass or PVC bags.
Danish: Der er påvist kemisk og fysisk stabilitet under brug i 24 timer ved temperaturer på op til 25 °C for præparat blandet med disse fortyndere, og som opbevares i glas- eller PVC beholdere.
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.
Danish: In vitro-data viser, at CYP2C9, CYP2C19 og CYP3A4 kan katalysere dannelsen af O-desmethylmetabolitten, men det primært involverede isoenzym er ikke blevet fastlagt in vivo.
English: In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite.
Danish: In vitro-data viser, at CYP2C9, CYP2C19 og CYP3A4 kan katalysere dannelsen af O-desmethylmetabolitten.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister label
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blisteretikette
English: The carton boxes of Lacosamide UCB syrup contain a 30 ml measuring cup with graduation marks and a 10 ml oral syringe.
Danish: Pakkerne med Lacosamide UCB-syrup indeholder et 30 ml målebæger med målestreger og en 10 ml oral sprøjte.
English: Children and adolescents weighing less than 50 kg Use the oral syringe and the adaptor provided in this pack.
Danish: Børn og unge, der vejer mindre end 50 kg • Brug den orale sprøjte og adapteren i denne pakning.
English: Allergic reaction to medicine intake, hives;
Danish: • Allergisk reaktion over for lægemidlet, nældefeber;
English: Measuring cup (for adolescents and children weighing 50 kg or more, and adults) Each graduation mark (5 ml) of the measuring cup corresponds to 50 mg lacosamide.
Danish: Målebæger (til unge og børn, der vejer 50 kg eller derover og voksne) Hver målestreg (5 ml) på målebægeret svarer til 50 mg lacosamid.
English: Suicidal ideation Hallucination (1)
Danish: Selvmordstanker Hallucinationer(1)
English: Therefore, dosage supplementation following haemodialysis is recommended (see section 4.2).
Danish: Dosistilskud efter hæmodialyse anbefales derfor (se pkt.
English: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Danish: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgien eller
English: Contains sorbitol (E420), sodium methyl parahydroxybenzoate (E219), aspartame (E951), and sodium.
Danish: Indeholder sorbitol (E 420), natriummethylparahydroxybenzoat (E 219), aspartam (E 951) og natrium.
English: • The other ingredients are glycerol (E422), carmellose sodium, sorbitol liquid (crystallizing) (E420), polyethylene glycol 4000, sodium chloride, citric acid anhydrous, acesulfame potassium (E950), sodium methyl parahydroxybenzoate (E219), strawberry flavour (contains propylene glycol, maltol), masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water), purified water.
Danish: • Øvrige indholdsstoffer: glycerol (E 422), carmellosenatrium, flydende sorbitol (krystalliserende) (E 420), polyethylenglycol 4000, natriumchlorid, citronsyre (vandfri), acesulfamkalium (E 950), natriummethylparahydroxybenzoat (E 219), jordbærsmagsstof (indeholder propylenglycol, maltol), maskerende aroma (indeholder propylenglycol, aspartam (E 951), acesulfamkalium (E 950), maltol, demineraliseret vand), renset vand.
English: PHARMACEUTICAL FORM AND CONTENTS 1 x 20 ml solution for infusion 200 mg/20 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 1 x 20 ml infusionsvæske, opløsning 200 mg/20 ml
English: The precise volume of solution for infusion is to be calculated according to the exact body weight of the child.
Danish: Den præcise mængde infusionsvæske beregnes i overensstemmelse med barnets nøjagtige kropsvægt.
English: Use of a loading dose is not recommended in adolescents and children weighing less than 50 kg.
Danish: Brug af en støddosis anbefales ikke til unge og børn, der vejer under 50 kg.
English: Film-coat: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants*.
Danish: Filmovertræk: Polyvinylalkohol, polyethylenglycol, talcum, titandioxid (E171), farvestoffer*.
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
Danish: 14 filmovertrukne tabletter 14 x 1 filmovertrukket tablet 28 filmovertrukne tabletter 56 filmovertrukne tabletter 56 x 1 filmovertrukket tablet
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
Danish: 14 filmovertrukne tabletter 14 x 1 filmovertrukket tablet 28 filmovertrukne tabletter 56 filmovertrukne tabletter 56 x 1 filmovertrukket tablet 168 filmovertrukne tabletter
English: Carton of 56 film-coated tablets 200 mg (without Blue Box)
Danish: Pakning med 56 filmovertrukne tabletter 200 mg (uden Blå Boks)
English: During the titration period, lacosamide doses were adjusted in 1or 2 mg/kg/day increments in subjects weighing less than 50 kg or 50 or 100 mg/day in subjects weighing 50 kg or more at weekly intervals to achieve the target maintenance period dose range.
Danish: Under titreringsperioden blev lacosamid-doserne justeret i trin på 1 eller 2 mg/kg/dag hos forsøgspersoner, der vejede under 50 kg, eller 50 eller 100 mg/dag hos forsøgspersoner, der vejede 50 kg eller derover, med ugentlige intervaller, for at opnå målet for vedligeholdelsesperiodens dosisområde.
English: Lacosamide UCB contains lacosamide.
Danish: Lacosamide UCB indeholder lacosamid.
English: Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
Danish: • Natriummethylparhydroxybenzoat (E 219) kan forårsage allergiske reaktioner (kan optræde efter behandlingen).
English: NAME OF THE MARKETING AUTHORISATION HOLDER UCB Pharma S.A.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN UCB Pharma S.A.
English: During the second week, the patient takes Lacosamide UCB 100 mg tablets twice a day.
Danish: Den anden uge tager patienten Lacosamide UCB 100 mg-tabletter to gange daglig.
English: Uncommon: may affect up to 1 in 100 people Injection site redness.
Danish: Ikke-almindelige: kan påvirke op til 1 ud af 100 personer • Rødme på injektionsstedet.
English: If a loading dose is indicated, an initial dose of 100 mg followed by a 50 mg twice daily regimen for the first week should be used.
Danish: Hvis en støddosis er påkrævet, bør der anvendes en initialdosis på 100 mg efterfulgt af 50 mg to gange daglig i den første uge.
English: Strong enzyme inducers such as rifampicin or St. John's wort (Hypericum perforatum) may moderately reduce the systemic exposure of lacosamide.
Danish: Stærke enzym-inducere såsom rifampicin eller prikbladet perikon (Hypericum perforatum) kan reducere lacosamids systemiske indvirkning i moderat grad.
English: Lacosamide UCB solution for infusion can be administered without further dilution, or may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) or lactated Ringer's solution.
Danish: Lacosamide UCB-infusionsvæske, opløsning kan gives uden yderligere fortynding eller kan fortyndes med følgende opløsninger: natriumchlorid 9 mg/ml (0,9 %), glucose 50 mg/ml (5 %) eller Ringer's laktat opløsning.
English: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone (polyplasdone XL-10 Pharmaceutical Grade), magnesium stearate.
Danish: Tabletkerne: Mikrokrystallinsk cellulose, hydroxypropylcellulose, lavsubstitueret hydroxypropylcellulose, kolloid vandfri silica, crospovidon (polyplasdon XL-10), magnesiumstearat.
English: Abnormal thinking or losing of touch with reality;
Danish: • Unormale tanker eller manglende virkelighedsopfattelse;
English: PHARMACEUTICAL FORM AND CONTENTS 200 mg/20 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 200 mg/20 ml
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om blindskrift
English: If you are not sure, talk to your doctor or pharmacist before using this medicine.
Danish: Hvis De ikke er sikker, skal De tale med lægen eller apotekspersonalet før De tager dette lægemiddel.
English: It is not recommended to take Lacosamide UCB if you are pregnant or breast-feeding, as the effects of Lacosamide UCB on pregnancy and the unborn baby or the new-born child are not known.
Danish: Det frarådes at tage Lacosamide UCB, hvis De er gravid eller ammer, da Lacosamide UCBs virkning på graviditeten og det ufødte barn eller det nyfødte barn ikke er kendt.
English: Lacosamide UCB is used in adolescents and children aged 4 years and older weighing 50 kg or more and in adults.
Danish: • Lacosamide UCB bruges til unge og børn i alderen 4 år og ældre, der vejer 50 kg eller derover og til voksne.
English: Carton of 56 film-coated tablets 150 mg (without Blue Box)
Danish: Pakning med 56 filmovertrukne tabletter 150 mg (uden Blå Boks)
English: In interaction trials lacosamide did not significantly affect the plasma concentrations of carbamazepine and valproic acid.
Danish: I interaktionsstudier påvirkede lacosamid ikke signifikant plasmakoncentrationen af carbamazepin og valproinsyre.
English: The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment (see section 4.2).
Danish: Lacosamids farmakokinetik er ikke blevet undersøgt ved alvorligt nedsat leverfunktion (se pkt.
English: INFORMATION IN BRAILLE Lacosamide UCB 10 mg/ml (only for the outer carton)
Danish: INFORMATION I BRAILLESKRIFT Lacosamide UCB 10 mg/ml (kun for den ydre pakning)
English: If you weigh 50 kg or more, your doctor may decide to start Lacosamide UCB treatment with a single “loading” dose of 200 mg (20 ml).
Danish: Hvis De vejer 50 kg eller mere, kan lægen beslutte at starte behandlingen med Lacosamide UCB med en enkelt ”støddosis” på 200 mg (20 ml).
English: The usual starting dose of Lacosamide UCB is 50 mg (5 ml) twice a day.
Danish: Den sædvanlige startdosis af Lacosamide UCB er 50 mg (5 ml) to gange om dagen.
English: The treatment initiation pack is only suitable in adolescents and children weighing 50 kg or more and in adults.
Danish: Behandlingsstartpakken er kun egnet til unge og børn, der vejer 50 kg eller derover og til voksne.
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).
Danish: Der er begrænsede kliniske data tilgængelige fra ældre epilepsipatienter, særligt ved doser over 400 mg/dag (se pkt.
English: Instructions for use are provided in the package leaflet.
Danish: Brugsanvisning findes i indlægssedlen.
English: 2 mg/kg/day
Danish: 2 mg/kg/dag
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.
Danish: De estimerede rater for 6 måneders anfaldsfrihed, som blev beregnet ved brug af Kaplan-Meieranalysemetoden for overlevelse, var 89,8 % for patienter, behandlet med lacosamid, og 91,1 % for patienter, behandlet med carbamazapin CR.
English: Ventricular tachyarrhythmia (1)
Danish: Ventrikulær takyarytmi(1)
English: Strawberry flavour (contains propylene glycol, maltol) Masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water) purified water
Danish: Jordbærsmagsstof (indeholder propylenglycol, maltol) Maskerende aroma (indeholder propylenglycol, aspartam (E 951), acesulfamkalium (E 950), maltol, demineraliseret vand)
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.
Danish: En maksimal dosis på 250 mg/dag anbefales til pædiatriske patienter, der vejer 50 kg eller derover og for voksne patienter med alvorligt nedsat nyrefunktion (CLCR ≤30 ml/min) og til patienter med nyresygdom i slutstadiet.
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR, the extent of increase in PR interval was comparable between lacosamide and carbamazepine.
Danish: I et klinisk studie, som sammenlignede monoterapibehandling med lacosamid og carbamazepin CR, var forlængelsen af PR-intervallet sammenlignelig for lacosamid og carbamazepin.
English: Monitor closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (e.g. myocardial ischemia, heart failure) when lacosamide dose is higher than 400 mg/day (see Method of administration below and section 4.4).
Danish: Patienter med overledningsforstyrrelser, som samtidig får lægemidler, der forlænger PR-intervallet, eller patienter med alvorlig hjertesygdom (f.eks. myokardieiskæmi, hjertesvigt), skal overvåges nøje, når dosis af lacosamid er højere end 400 mg/dag (se Administration nedenfor og pkt.
English: Common: may affect up to 1 in 10 children
Danish: Almindelige: kan påvirke op til 1 ud af 10 børn
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TREATMENT INITIATION PACK ONLY Outer carton - treatment initiation pack containing 4 cartons of 14 film-coated tablets
Danish: Yderkarton - behandlingsstartpakke, der indeholder 4 kartoner á 14 filmovertrukne tabletter
English: Tablet core microcrystalline cellulose hydroxypropylcellulose hydroxypropylcellulose (low substituted) silica, colloidal, anhydrous crospovidone (polyplasdone XL-10 Pharmaceutical Grade) magnesium stearate
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose Hydroxypropylcellulose (lavsubstitueret) Silica, kolloid vandfri Crospovidon (polyplasdon XL-10) Magnesiumstearat
English: 200 mg tablet: indigo carmine aluminium lake (E132).
Danish: 200 mg tablet: Indigocarmin aluminium lake (E132).
English: Take off the adaptor from the oral syringe (figure 2).
Danish: • Tag adapteren ud af den orale sprøjte (figur 2).
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.
Danish: 21,0 % (13/62) af de ældre patienter seponerede lacosamid på grund af bivirkninger versus 9,2 % (35/382) af de yngre voksne patienter.
English: One full oral syringe (10 ml) corresponds to 100 mg of lacosamide.
Danish: En fuld oral sprøjte (10 ml) svarer til 100 mg lacosamid.
English: Laboratory abnormalities
Danish: Laboratorieanormaliteter
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.
Danish: Den typiske plasmaclearance var estimeret til 1,04 l/t, 1,32 l/t og 1,86 l/t for børn, der vejede henholdsvis 20 kg, 30 kg og 50 kg. Til sammenligning skønnedes plasmaclearance til 1,92 l/t hos voksne (70 kg kropsvægt).
English: The efficacy of lacosamide in children aged 4 years and older has been extrapolated from data of adolescents and adults with partial-onset seizures, for whom a similar response was expected provided the paediatric dose adaptations are established (see section 4.2) and safety has been demonstrated (see section 4.8).
Danish: Effekten af lacosamid hos børn i alderen 4 år og ældre er blevet ekstrapoleret ud fra data fra unge og voksne med anfald af partiel type, da et lignende respons hos den pædiatriske population er forventet, forudsat at pædiatriske dosistilpasninger er etableret (se pkt.
English: Lacosamide is effectively removed from plasma by haemodialysis.
Danish: Hæmodialyse fjerner effektivt lacosamid fra plasma.
English: The treatment with Lacosamide UCB may also start with a dose of 100 mg of Lacosamide UCB twice a day.
Danish: Behandlingen med Lacosamide UCB kan også opstartes med en dosis på 100 mg Lacosamide UCB to gange dagligt.
English: 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 0.5 ml/kg Maximum recommended dose: 0.6 ml/kg
Danish: 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 0.5 ml/kg 0,6 ml/kg Maksimal anbefalet dosis
English: Bradycardia(1,2) Atrial Fibrillation Atrial Flutter (1,2)
Danish: Bradykardi(1,2) Atrieflimren(1,2) Atrieflagren(1,2)
English: The measuring cup is suitable for adults, adolescents and children weighing 50 kg and above.
Danish: • Målebægeret er velegnet til voksne, unge og børn, der vejer 50 kg og derover.