FrancophonIA/ELRC3.0 huggingface dataset:
English: If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time.
Danish: Hvis en dosis glemmes, skal patienten instrueres i at tage den glemte dosis med det samme og derefter tage den næste dosis lacosamid til det normale tidspunkt.
English: In juvenile dogs, transient and dose-related CNS clinical signs started to be observed at systemic exposure levels below the expected clinical exposure.
Danish: Hos unghunde begyndte forbigående og dosisrelaterede CNSkliniske tegn at blive observeret ved systemiske eksponeringsniveauer under den forventede kliniske eksponering.
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).
Danish: Egnede patienter på et stabilt dosisregimen på 1 til 3 antiepileptiske lægemidler, som stadig oplevede mindst 2 partielle anfald i løbet af de 4 uger, der gik forud for screening, med anfaldsfri fase på ikke mere end 21 dage i 8 ugers perioden før starten på baseline perioden, blev randomiseret til at få enten placebo (n=172) eller lacosamid (n=171).
English: 08039 Barcelona, Spain
Danish: 08040 Barcelona, Spanien eller
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).
Danish: I dette studie blev 425 patienter mellem 16 og 70 år med ukontrollerede anfald af partiel type, som tog stabile doser af 1 eller 2 markedsførte antiepileptiske lægemidler, randomiseret til konvertering til lacosamid-monoterapi (enten 400 mg/dag eller 300 mg/dag, i forholdet 3:1).
English: Lacosamide Accord is indicated as monotherapy and adjunctive therapy in the treatment of partialonset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Danish: Lacosamide Accord er indiceret som monoterapi og tillægsbehandling af fokale anfald med eller uden sekundær generalisering hos voksne, unge og børn fra 4 år med epilepsi.
English: The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in openlabel studies (n=408) in adjunctive therapy in children from 4 years of age was consistent with the safety profile observed in adults although the frequency of some adverse reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions (nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %).
Danish: Sikkerhedsprofilen af lacosamid i placebo-kontrollerede (se oplysninger om studiet i punkt 5.1) og i open-label studier (n=408) som tillægsbehandling hos børn fra 4 år var i overensstemmelse med sikkerhedsprofilen observeret hos voksne, selv om hyppigheden af nogle bivirkninger (somnolens, opkastning og kramper) var øget, og der er rapporteret yderligere bivirkninger (nasopharyngitis, pyreksi, pharyngitis, nedsat appetit, letargi og unormal adfærd) hos pædiatriske patienter: nasopharyngitis (15,7 %), opkastning (14,7 %), somnolens (14,0 %), svimmelhed (13,5 %), pyreksi (13,0 %), kramper (7,8 %), nedsat appetit (5,9 %), pharyngitis (4,7 %), letargi (2,7 %) og unormal adfærd (1,7 %).I alt rapporterede 67,8 % af patienter, randomiseret til lacosamid, og 58,1 % af patienter, randomiseret til placebo, mindst 1 bivirkning.
English: Titanium dioxide (E171) Lecithin (soya)
Danish: Titandioxid (E171) Lecithin (soja)
English: Nervous system side effects such as dizziness may be higher after a single “loading” dose.
Danish: Bivirkninger fra nervesystemet, såsom svimmelhed, kan være hyppigere efter en enkelt støddosis.
English: This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day.
Danish: Dette vil være indtil De når en vedligeholdelsesdosis mellem 100 mg og 300 mg to gange dagligt.
English: • Lacosamide Accord is used in adolescents and children aged 4 years and older weighing 50 kg or more and in adults.
Danish: • Lacosamid Accord bruges til unge og børn i alderen 4 år og ældre, der vejer 50 kg eller derover og til voksne.
English: The usual starting dose of Lacosamide Accord is 50 mg twice a day.
Danish: Den sædvanlige startdosis af Lacosamide Accord er 50 mg to gange dagligt.
English: 100 mg/day or 200 mg/day
Danish: 100 mg/dag eller 200 mg/dag 100 mg/dag
English: What you need to know before you take Lacosamide Accord
Danish: Det skal De vide, før De begynder at tage Lacosamide Accord
English: Tablet core: Microcrystalline cellulose, hydroxy propyl cellulose-L, hydroxy propyl cellulose (low substituted), silica colloidal anhydrous, crospovidone and magnesium stearate.
Danish: Tabletkerne: Mikrokrystallinsk cellulose, hydroxypropylcellulose-L, hydroxypropylcellulose (lavsubstitueret), kolloid vandfri silica, crospovidon og magnesiumstearat.
English: Lacosamide Accord contains lacosamide.
Danish: Lacosamide Accord indeholder lacosamid.
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.
Danish: De administrerede doser af lacosamid varierede fra 2 til 17,8 mg/kg /dag med indtag to gange dagligt, af højst 600 mg/dag for børn, der vejede 50 kg eller derover.
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.
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: Also, it is not known whether Lacosamide Accord passes into the breast milk.
Danish: Det vides heller ikke, om Lacosamide Accord går over i modermælken.
English: Hypersensitivity to the active substance, soya lecithin or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, sojalecitin eller over for et eller flere af hjælpestofferne anført i pkt.
English: Polyethylene glycol Talc
Danish: Polyethylenglycol talkum
English: The treatment initiation pack is only suitable in adolescents and children weighing 50 kg or more and in adults.
Danish: Behandlingsinitieringspakken er kun egnet til unge og børn, der vejer 50 kg eller derover og til voksne.
English: This will be until you reach a maintenance dose between 100 mg and 200 mg twice a day.
Danish: Dette vil være indtil De når en vedligeholdelsesdosis mellem 100 mg og 200 mg to gange dagligt.
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).
Danish: Hvis De tager Lacosamide Accord, og De oplever symptomer på unormal puls (såsom langsom, hurtig eller uregelmæssig puls, hjertebanken, åndenød, følelse af at være uklar, være ved at besvime), skal De straks søge læge (se pkt.
English: Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord twice a day.
Danish: Lægen kan også ordinere en startdosis på 100 mg Lacosamide Accord to gange dagligt.
English: • a herbal medicine used to treat mild anxiety and depression called St.John's wort.
Danish: • En urtemedicin, der anvendes til behandling af mild angst og depression kaldet perikum.
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.
Danish: Lacosamide Accord er indiceret som monoterapi og tillægsbehandling af fokale anfald med eller uden sekundær generalisering hos unge og børn fra 4 år, der vejer 50 kg eller derover og hos voksne med epilepsi.
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.
Danish: Baseret på en analyse af data fra et non-inferioritetsstudie med monoterapi, som sammenlignede lacosamid med carbamazepin depotformulering (CR), var de hyppigst rapporterede bivirkninger (≥10 %) for lacosamid, hovedpine og svimmelhed.
English: Therefore dosage supplementation following haemodialysis is recommended (see section 4.2).
Danish: Dosistilskud efter hæmodialyse anbefales derfor (se pkt.
English: • feeling sick (nausea) or being sick (vomiting);
Danish: • Sygdomsfornemmelse (kvalme) eller sygdom (opkastning);
English: Abnormal thinking or losing touch with reality;
Danish: • Unormale tanker eller manglende virkelighedsopfattelse
English: Polyvinyl alcohol Polyethylene glycol Talc
Danish: Tabletovertræk Polyvinylalkohol Polyethylenglycol Talkum
English: Elevations of ALT to ≥3x ULN occurred in 0.7 % (7/935) of Lacosamide patients and 0 % (0/356) of placebo patients.
Danish: ALATstigning til ≥ 3 x øvre normalgrænse forekom hos 0,7 % (7/935) af lacosamid-patienterne og hos 0 % (0/356) af placebopatienterne.
English: Adolescents and children weighing 50 kg or more and adults When you take Lacosamide Accord on its own
Danish: Unge og børn, der vejer 50 kg eller derover, samt voksne Hvis De kun tager Lacosamide Accord
English: In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the Odesmethyl metabolite.
Danish: In vitro-data viser, at CYP2C9, CYP2C19 og CYP3A4 kan katalysere dannelsen af O-desmethylmetabolitten.
English: If you forget to take Lacosamide Accord
Danish: Hvis De har glemt at tage Lacosamide Accord
English: Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Danish: • Opkastning, tør mund, forstoppelse, fordøjelsesbesvær, for megen luft i mave eller tarm, diarré
English: During the second week, the patient takes Lacosamide Accord 100 mg tablets twice a day.
Danish: Den anden uge tager patienten Lacosamide Accord 100 mg-tabletter to gange daglig.
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);
Danish: • Udbredt udslæt med blærer og skællende hud, især omkring munden, næsen, øjnene og kønsdelene (Stevens-Johnsons syndrom), og en mere alvorlig form, der forårsager hudafskalning på mere end 30 % af kropsoverfladen (toksisk epidermal nekrolyse);
English: On the first day of treatment the patient starts with Lacosamide Accord 50 mg tablets twice a day.
Danish: Den første behandlingsdag starter patienten med Lacosamide Accord 50 mg-tabletter to gange daglig.
English: Lacosamide Accord may make you dizzy -this could increase the risk of accidental injury or a fall.
Danish: Lacosamide Accord kan medføre svimmelhed, der vil kunne øge risikoen for tilskadekomst eller fald.
English: The 14 x 1 or 56 x 1 tablet pack is available as perforated unit dose PVC-PVDC/Aluminium blisters sealed with an aluminium foil, all other packs are available with standard PVC-PVDC/Aluminium blisters sealed with an aluminium foil.
Danish: Pakningen med 14 x 1 eller 56 x 1 fås som perforeret enhedsdosis PVC-PVDC/aluminiumsblister forseglet med en aluminiumsfolie.
English: In adolescents and adults weighing 50 kg or more, a loading dose of 200 mg may be considered, but further dose titration (> 200 mg daily) should be performed with caution.
Danish: Til unge og voksne, der vejer 50 kg eller derover kan en støddosis på 200 mg overvejes, dog bør yderligere dosistitrering (>200 mg/dag) ske med forsigtighed.
English: If you stop taking Lacosamide Accord
Danish: Hvis De holder op med at tage Lacosamide Accord
English: Flatulence Dyspepsia Dry mouth Diarrhoea
Danish: Opkastning Forstoppelse Flatulens Dyspepsi Mundtørhed Diarré
English: Liver function test abnormal (2)
Danish: Unormale leverfunktionsprøver(2)
English: • If your doctor decides to stop your treatment with Lacosamide Accord , they will tell you how to decrease the dose step by step.
Danish: • Hvis lægen beslutter at stoppe behandlingen med Lacosamide Accord, vil han eller hun fortælle
English: Paediatric population Adolescents and children weighing 50 kg or more
Danish: Pædiatrisk population Unge og børn på 50 kg eller derover
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
English: If you weigh 50 kg or more, your doctor may decide to start Lacosamide Accord treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.
Danish: Hvis De vejer 50 kg hver uge eller mere, kan lægen beslutte at starte behandlingen med Lacosamide Accord med en enkelt ”støddosis” på 200 mg.
English: What Lacosamide Accord is
Danish: Hvad Lacosamide Accord er
English: Allergic reaction to medicine intake, hives;
Danish: • Allergisk reaktion over for lægemidlet, nældefeber
English: The following table summarises the recommended posology in adjunctive therapy for children and adolescents weighing less than 50 kg.
Danish: Den følgende tabel opsummerer den anbefalede dosering ved tillægsbehandling til børn og unge, der vejer mindre end 50 kg.
English: Lacosamide Accord contains soya lecithin.
Danish: Lacosamide Accord indeholder sojalecithin.
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.
Danish: Der blev observeret nedsat atrial- og ventrikulær ledningsevne, atrioventrikulær blok og atrioventrikulær dissociation i bedøvede hunde og Cynomolgus-aber ved intravenøse doser på 15-60 mg/kg.
English: What Lacosamide Accord is used for
Danish: Hvad Lacosamide Accord bruges til
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
Danish: Hver pakning á 56 filmovertrukne tabletter til en 4 ugers behandlingsplan indeholder: 14 filmovertrukne Lacosamide Accord-tabletter 50 mg 14 filmovertrukne Lacosamide Accord-tabletter 100 mg 14 filmovertrukne Lacosamide Accord-tabletter 150 mg 14 filmovertrukne Lacosamide Accord-tabletter 200 mg
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.
Danish: Hos pædiatriske patienter, der vejer 50 kg eller derover og hos voksne patienter med alvorligt nedsat nyrefunktion (CLCR ≤30 ml/min) eller med nyresygdom i slutstadiet anbefales en maksimal dosis på 250 mg/dag og dosistitering bør foretages med forsigtighed.
English: Maximum recommended dose in patients ≥ 30 kg to < 50 kg up to 8 mg/kg/day
Danish: Maksimal anbefalet dosis hos patienter ≥ 30 kg til < 50 kg
English: If you take more Lacosamide Accord than you should If you have taken more Lacosamide Accord than you should, contact your doctor immediately.
Danish: Hvis De har taget for meget Lacosamide Accord Kontakt straks lægen, hvis De har taget for meget Lacosamide Accord.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide Accord.
Danish: Hvis noget af ovenstående gælder for Dem (eller De ikke er sikker), skal De tale med lægen eller apotekspersonalet før De tager Lacosamide Accord.
English: Adolescents and children weighing 50 kg or more, and adults
Danish: Unge og børn på 50 kg eller derover og voksne
English: Packs of 14 x 1 or 56 x 1 tablet in perforated unit dose blisters Not all pack sizes may be marketed.
Danish: Pakninger med 14 x 1 eller 56 x 1 tablet i perforeret enkeltdosisblister
English: In paediatric patients weighing 50 kg or more and in adult patients with mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose titration (> 200 mg daily) should be performed with caution.
Danish: Hos pædiatriske patienter, der vejer 50 kg eller derover og hos voksne patientpopulationer med let til moderat nedsat nyrefunktion kan en støddosis på 200 mg overvejes, dog bør yderligere dosistitrering (>200 mg/dag) ske med forsigtighed.
English: Titration (incremental steps)
Danish: Titrering (trinvise dosisjustering)
English: Sleepiness, tiredness, or weakness (asthenia);
Danish: • Søvnighed, træthed, svaghed (asteni)
English: What Lacosamide Accord is and what it is used for What you need to know before you take Lacosamide Accord How to take Lacosamide Accord Possible side effects
Danish: Det skal De vide, før De begynder at tage Lacosamide Accord Sådan skal De tage Lacosamide Accord Bivirkninger
English: The doctor will prescribe the formulation that is best suited to them.
Danish: Lægen vil ordinere det Lacosamide Accord produkt, der passer bedst til barnet.
English: Adolescents and children weighing 50 kg or more, and adults Monotherapy
Danish: Unge og børn på 50 kg eller derover og voksne Som monoterapi
English: The following table summarises the recommended posology in monotherapy for children and adolescents weighing less than 50 kg.
Danish: I nedenstående tabel opsummeres den anbefalede dosering ved monoterapi til børn og unge, der vejer mindre end 50 kg.
English: 50 mg tablet: Iron oxide red (E172), iron oxide black (E172), indigo carmine aluminum lake (E132) 100 mg tablet: Iron oxide yellow (E172)
Danish: 50 mg tablet: rød jernoxid (E172), sort jernoxid (E172), indigocarmin aluminium lake (E132) 100 mg tablet: gul jernoxid (E172)
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172) Indigo carmine aluminum lake (E132) Lecithin (soya)
Danish: Titandioxid (E171) Rød jernoxid (E172) Sort jernoxid (E172) Indigokarmin aluminium lake (E132) Lecithin (soja)
English: Lacosamide Accord 100 mg film coated tablets: EU/1/17/1230/005-008
Danish: Lacosamide Accord 100 mg filmovertrukne tabletter EU/1/17/1230/005-008
English: The discontinuation rate due to adverse reactions was 10.6 % for patients treated with lacosamide and 15.6 % for patients treated with carbamazepine CR.
Danish: 10,6 % af patienterne i lacosamid-armen seponerede behandlingen på grund af bivirkninger mod 15,6 % af patienterne i carbamazepin CRarmen.
English: Lacosamide Accord 50 mg film coated tablets: EU/1/17/1230/001-004
Danish: Lacosamide Accord 50 mg filmovertrukne tabletter EU/1/17/1230/001-004
English: Lacosamide Accord 150 mg film coated tablets: EU/1/17/1230/009-012
Danish: Lacosamide Accord 150 mg filmovertrukne tabletter EU/1/17/1230/009-012
English: Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention; Noise in the ear such as buzzing, ringing or whistling;
Danish: • Nedsat følelse eller følsomhed, svært ved at formulere ord, opmærksomhedsforstyrrelser
English: TREATMENT INITIATION PACK ONLY Intermediate Carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KUN BEHANDLINGSSTARTPAKKE Indre karton
English: the package marked ‘Week 3' contains 14 tablets of 150 mg, the package marked ‘Week 4' contains 14 tablets of 200 mg .
Danish: • æsken mærket ‘Uge 4' indeholder 14 tabletter á 200 mg.
English: 150 mg tablet: Iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172) 200 mg tablet: Indigo carmine aluminum lake (E132)
Danish: 150 mg tablet: rød jernoxid (E172), sort jernoxid (E172), gul jernoxid (E172) 200 mg tablet: indigocarmin aluminium lake (E132)
English: Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis); A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes).
Danish: • En alvorlig hudreaktion, som kan omfatte høj temperatur og andre influenzalignende symptomer, udslæt i ansigtet, udbredt udslæt, hævede kirtler (forstørrede lymfeknuder).
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.
Danish: Hos pædiatriske patienter med alvorlig nedsat nyrefunktion (CLCR ≤ 30 ml/min), der vejer mindre end 50 kg og hos patienter med nyresygdom i slutstadiet, anbefales en reduktion på 25 % af den maksimale dosis.
English: Aggression Agitation(1) Euphoric mood(1) Psychotic disorder(1) Suicide attempt (1)
Danish: Psykotiske forstyrrelser(1) Selvmordsforsøg(1)
English: Do not take Lacosamide Accord if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for lacosamid eller et af de øvrige indholdsstoffer i Lacosamide
English: Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Graviditet og amning Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid,
English: Uncommon: may affect up to 1 in 100 children
Danish: Ikke almindelige: kan påvirke op til 1 ud af 100 børn
English: 200 mg (1 tablet Lacosamide Accord 200 mg)
Danish: 200 mg (1 Lacosamide Accordtablet 200 mg)
English: Lacosamide Accord 200 mg are blue, oval, approximately 16.4 x 7.6 mm, coated tablets, debossed “L” on one side and “200” on other side.
Danish: Lacosamide Accord 200 mg er blå, ovale filmovertrukne tabletter, ca. 16,4 x 7,6 mm, præget med ‘L' på den ene side og ‘200' på den anden.
English: 150 mg (1 tablet Lacosamide Accord 150 mg)
Danish: 150 mg (1 Lacosamide Accordtablet 150 mg)
English: 50 mg (1 tablet Lacosamide Accord 50 mg)
Danish: 50 mg (1 Lacosamide Accordtablet 50 mg)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TREATMENT INITIATION PACK ONLY Blister label - week 2
Danish: KUN BEHANDLINGSSTARTPAKKE MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blisteretikette - uge 2
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.
Danish: Lacosamide Accord 100 mg er mørkegule, ovale filmovertrukne tabletter, ca. 13,0 x 6,0 mm, præget med ‘L' på den ene side og ‘100' på den anden.
English: 100 mg (1 tablet Lacosamide Accord 100 mg)
Danish: 100 mg (1 Lacosamide Accordtablet 100 mg)
English: Lacosamide Accord 150 mg are salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed “L” on one side and “150” on other side.
Danish: Lacosamide Accord 150 mg laksefarvede, ovale filmovertrukne tabletter, ca. 15,0 x 6,9 mm, præget med ‘L' på den ene side og ‘150' på den anden.
English: Symptoms
Danish: Bivirkninger