FrancophonIA/ELRC3.0 huggingface dataset:
English: Each package contains a different dosage strength of Vimpat, so you will increase your dose gradually.
Danish: Hver æske indeholder en forskellig Vimpat-dosisstyrke, så Deres dosis vil stige gradvist.
English: Vimpat can be started by: - taking the medicine by mouth or - by being given as an intravenous infusion (sometimes called an “IV infusion”) where the medicine is given into your vein by a doctor or nurse.
Danish: • Vimpat kan opstartes ved: - At tage medicinen igennem munden eller - Ved at få den som en intravenøs infusion (også kaldet en "IV-infusion"), hvor lægemidlet indgives i Deres blodåre af en læge eller sygeplejerske.
English: The bottle containing Vimpat syrup should be shaken well before use.
Danish: Flasken med Vimpat syrup skal omrystes grundigt inden brug.
English: When you take Vimpat with other antiepileptic medicines - Start of the treatment (the first 4 weeks)
Danish: Hvis De tager Vimpat sammen med anden medicin mod epilepsi - Behandlingsstart (de første 4 uger)
English: Do not stop taking Vimpat without talking to your doctor, as your epilepsy may come back again or become worse.
Danish: • Stop ikke med at tage Vimpat uden først at tale med Deres læge, da Deres epilepsi kan komme tilbage igen eller blive værre.
English: (4) Local adverse reactions associated with intravenous administration.
Danish: Lokale bivirkninger associeret med intravenøs administration.
English: There is experience with twice daily infusions of Vimpat for up to 5 days.
Danish: Der er erfaring med infusioner af Vimpat to gange dagligt i op til 5 dage.
English: They will help you decide if you should take Vimpat or not.
Danish: Lægen vil hjælpe Dem med at beslutte, om De skal tage Vimpat eller ej.
English: If multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued.
Danish: Hvis der er mistanke om en multiorganoverfølsomhedsreaktion, bør lacosamid seponeres.
English: България Ю СИ БИ България ЕООД
Danish: Ю СИ БИ България ЕООД Teл.
English: Vimpat 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.
Danish: Vimpat-behandlingsstartpakken indeholder 4 forskellige pakninger (én til hver tabletstyrke) med 14 tabletter i hver til de første 2-4 ugers behandling afhængigt af virkningen og bivirkningsprofilen hos den enkelte patient.
English: Vimpat tablets and oral syrup are bioequivalent.
Danish: Vimpat-tabletter og oral syrup er bioækvivalente.
English: Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Vimpat patients and 0 % (0/356) of placebo patients.
Danish: ALATstigning til ≥ 3 x øvre normalgrænse forekom hos 0,7 % (7/935) af Vimpat-patienterne og hos 0 % (0/356) af placebopatienterne.
English: Syncope(2) Coordination abnormal
Danish: Synkope Abnorm koordination
English: Use the oral syringe and the adaptor provided in this pack.
Danish: • Brug den orale sprøjte og adapteren i denne pakning.
English: Each vial of Vimpat solution for infusion must be used only once (single use).
Danish: Hvert hætteglas med Vimpat-infusionsvæske, opløsning, må kun bruges én gang (engangsbrug).
English: 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: Sorbitol (a type of sugar): This medicine contains 187 mg sorbitol in each ml.
Danish: • Sorbitol (en sukkerart): Dette lægemiddel indeholder 187 mg sorbitol pr. ml.
English: This medicine contains 59.8 mg sodium (main component of cooking/table salt) in each vial.
Danish: Dette lægemiddel indeholder 59,8 mg natrium (hovedkomponenten af madlavnings-/bordsalt) pr. hætteglas.
English: Vimpat 10 mg/ml (only for the outer carton)
Danish: Vimpat 10 mg/ml (kun for den ydre pakning)
English: Listed below are the normal recommended doses of Vimpat for different age groups and weights.
Danish: Nedenfor er de normale anbefalede doser af Vimpat til forskellige aldersgrupper og vægte angivet.
English: Vimpat contains lacosamide.
Danish: Vimpat indeholder lacosamid.
English: This is equivalent to 3 % of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 3 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister label
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: Also, it is not known whether Vimpat passes into the breast milk.
Danish: Det vides heller ikke, om Vimpat går over i modermælken.
English: Vimpat syrup contains 1.42 mg sodium per ml, equivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Vimpat-syrup indeholder 1,42 mg natrium pr. ml svarende til 0,07 % af den WHO anbefalede maksimale daglige indtagelse på 2 g natrium for en voksen.
English: (2) See Description of selected adverse reactions.
Danish: Se Beskrivelse af udvalgte bivirkninger.
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).
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 lacosamidmonoterapi (enten 400 mg/dag eller 300 mg/dag, i forholdet 3:1).
English: Vimpat is used in adults, adolescents and children aged 4 years and older.
Danish: • Vimpat bruges til voksne, unge og børn i alderen 4 år og ældre.
English: The dose depends on their body weight.
Danish: Dosis afhænger af barnets kropsvægt.
English: Not known: frequency cannot be estimated from available data Changes in behaviour, not acting like themselves.
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data • Ændringer i adfærd, virker ikke som sig selv.
English: Vimpat contains sorbitol, sodium, sodium methyl parahydroxybenzoate, aspartame and propylene glycol
Danish: Vimpat indeholder sorbitol, natrium, natriummethylparahydroxybenzoat, aspartam og propylenglycol
English: If you forget to take Vimpat
Danish: Hvis De har glemt at tage Vimpat
English: This is equivalent to 0.07 % of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 0,07 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: Vimpat syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria.
Danish: Vimpat-syrup indeholder aspartam (E 951), en phenylalaninkilde, som kan være skadelig for patienter med fenylketonuri (PKU, Føllings sygdom).
English: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Danish: UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgien.
English: Vimpat is not recommended for children aged under 4 years.
Danish: Vimpat bør ikke anvendes til børn under 4 år.
English: Vimpat 10 mg/ml solution for infusion is an alternative for patients when oral administration is temporarily not feasible.
Danish: Vimpat 10 mg/ml infusionsvæske, opløsning er et alternativ til patienter, når oral administration midlertidigt ikke er muligt.
English: This medicinal product contains 59.8 mg sodium per vial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 59, 8 mg natrium pr. hætteglas, svarende til 3 % af den WHO anbefalede maksimale daglige indtagelse på 2 g natrium for en voksen.
English: Aspartame (E951): This medicine contains 0.032 mg aspartame in each ml.
Danish: • Aspartam (E 951): Dette lægemiddel indeholder 0,032 mg aspartam pr. ml.
English: UCB Magyarország Kft. Tel.: + 36-(1) 391 0060
Danish: Magyarország UCB Magyarország Kft. Tel.: + 36-(1) 391 0060
English: Vimpat contains sodium
Danish: Vimpat indeholder natrium
English: Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision; A spinning sensation (vertigo), feeling drunk;
Danish: • Hurtige og ukontrollerbare øjenbevægelser (nystagmus), sløret syn;
English: Sodium (salt): This medicine contains 1.42 mg sodium (main component of cooking/table salt) in each ml.
Danish: • Natrium (salt): Dette lægemiddel indeholder 1,42 mg natrium (hovedkomponenten af madlavnings-/bordsalt) pr. ml.
English: (2) Dosage in adolescents 50 kg or more is the same as in adults.
Danish: Dosering hos unge på 50 kg eller mere er den samme som hos voksne.
English: Vimpat may make you dizzy - this could increase the risk of accidental injury or a fall.
Danish: Vimpat kan medføre svimmelhed, der vil kunne øge risikoen for tilskadekomst eller fald.
English: System organ class Very common
Danish: Systemorganklasse
English: You will start your treatment with a low dose of Vimpat, usually 50 mg twice a day, and increase it week by week.
Danish: De starter behandlingen med en lav dosis Vimpat, almindeligvis 50 mg 2 gange dagligt, og dosis øges uge efter uge.
English: Treatment initiation pack
Danish: KUN BEHANDLINGSSTARTPAKKE
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: In treated patients who completed titration and started withdrawing antiepileptic medicinal products (284 and 99 respectively), monotherapy was maintained in 71.5 % and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation period of 70 days.
Danish: Hos behandlede patienter, som fuldførte titrering og påbegyndte seponering af antiepileptiske lægemidler (henholdsvis 284 og 99), blev monoterapi opretholdt i 57-105 dage (median 71 dage) hos henholdsvis 71,5 % og 70,7 % af patienterne i løbet af den forudbestemte 70-dages observationsperiode.
English: Other medicines and Vimpat
Danish: Brug af anden medicin sammen med Vimpat
English: Vimpat is available in a bottle of 200 ml.
Danish: • Vimpat fås i en flaske med 200 ml.
English: During the second week, the patient takes Vimpat 100 mg tablets twice a day.
Danish: Den anden uge tager patienten Vimpat 100 mg-tabletter to gange daglig.
English: Put the oral syringe into the adaptor opening (figure 4).
Danish: • Sæt den orale sprøjte i adapteråbningen (figur 4).
English: Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Vimpat 50 mg film-coated tablets
Danish: Behandlingsstartpakning (kun til unge og børn, der vejer 50 kg eller derover og til voksne) Vimpat 50 mg filmovertrukne tabletter
English: The treatment initiation pack contains 4 cartons, each carton with 14 Vimpat film-coated tablets of 50 mg, 100 mg, 150 mg and 200 mg.
Danish: Behandlingsstartpakken indeholder 4 pakninger, der hver indeholder 14 Vimpat filmovertrukne tabletter á 50 mg, 100 mg, 150 mg og 200 mg.
English: If you are taking Vimpat 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 Vimpat, 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: The most frequently reported adverse reactions (≥ 10 %) with lacosamide treatment were dizziness, headache, nausea and diplopia.
Danish: De mest almindeligt rapporterede bivirkninger (≥ 10 %) ved lacosamidbehandling var svimmelhed, hovedpine, kvalme og diplopi (dobbeltsyn).
English: Sorbitol liquid (crystallizing) (E420) Polyethylene glycol 4000
Danish: Flydende sorbitol (krystalliserende) (E 420) Polyethylenglycol 4000
English: Contains sodium chloride, hydrochloric acid, water for injections.
Danish: Indeholder natriumchlorid, saltsyre, vand til injektionsvæsker.
English: Depending on response and tolerability, Vimpat 150 mg tablets may be taken twice a day during the third week and Vimpat 200 mg tablets twice a day during the fourth week.
Danish: Afhængigt af respons og tolerabilitet kan Vimpat 150 mg-tabletter tages to gange daglig i tredje uge og Vimpat 200 mg-tabletter to gange daglig i fjerde uge.
English: Using Vimpat
Danish: Brug af Vimpat
English: As a safety precaution do not use Vimpat with alcohol.
Danish: Brug af Vimpat sammen med alkohol Som sikkerhedsforanstaltning bør Vimpat ikke tages sammen med alkohol.
English: Τηλ: + 357 22 05 63 00
Danish: Ltd Τηλ: + 357 22 05 63 00
English: • Vimpat is used in adolescents and children aged 4 years and older weighing 50 kg or more and in adults.
Danish: • Vimpat bruges til unge og børn i alderen 4 år og ældre, der vejer 50 kg eller derover og til voksne.
English: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany or
Danish: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Tyskland eller
English: The carton boxes of Vimpat syrup contain a 30 ml measuring cup with graduation marks and a 10 ml oral syringe.
Danish: Pakkerne med Vimpat-syrup indeholder et 30 ml målebæger med målestreger og en 10 ml oral sprøjte.
English: Each ml of Vimpat syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl parahydroxybenzoate (E219), 2.14 mg propylene glycol (E1520), 1.42 mg sodium, and 0.032 mg aspartame (E951).
Danish: Hver ml Vimpat syrup indeholder 187 mg sorbitol (E420), 2,60 mg natriummethylparahydroxybenzoat (E 219), 2,14 mg propylenglycol (E 1520), 1,42 mg natrium og 0,032 mg aspartam (E 951).
English: Packs of 60 film-coated tablets in HDPE bottle with a child-resistant closure.
Danish: Pakninger med 60 filmovertrukne tabletter i HDPD-beholder med børnesikret lukning.
English: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Danish: Indehaver af markedsføringstilladelsen UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgien.
English: If you stop using Vimpat
Danish: Hvis De holder op med at bruge Vimpat
English: 200 ml syrup with measuring cup and oral syringe
Danish: 200 ml syrup med målebæger og oral sprøjte
English: If you stop taking Vimpat
Danish: Hvis De holder op med at tage Vimpat
English: In children from 4 years of age with a body weight of under 20 kg:
Danish: Hos børn fra 4 år med en kropsvægt på under 20 kg:
English: Vimpat solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in glass or PVC bags at temperatures up to 25°C.
Danish: Vimpat-infusionsvæske, opløsning er fysisk kompatibelt og kemisk stabilt i mindst 24 timer, når den blandes med følgende fortyndere og opbevares i glas eller PVC-poser ved temperaturer op til 25 °C.
English: Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there; Allergic reaction to medicine intake, hives;
Danish: • Overdreven følelse af velvære, De ser og/eller hører ting, der ikke er der;
English: Vimpat syrup contains sodium methyl parahydroxybenzoate (E219), which may cause allergic reactions (possibly delayed).
Danish: Vimpat-syrup indeholder natriummethylparahydroxybenzoat (E 219), der kan give allergiske reaktioner (kan optræde efter behandlingen).
English: Vimpat 10 mg/ml solution for infusion is a clear, colourless solution.
Danish: • Vimpat 10 mg/ml infusionsvæske er en klar, farveløs opløsning.
English: Stevens-Johnson syndrome(1) Toxic epidermal necrolysis(1)
Danish: StevensJohnsons syndrom Toksisk epidermal nekrolyse
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: On the first day of treatment the patient starts with Vimpat 50 mg tablets twice a day.
Danish: Den første behandlingsdag starter patienten med Vimpat 50 mg-tabletter to gange daglig.
English: If your doctor decides to stop your treatment with Vimpat, they will decrease the dose step by step.
Danish: Hvis lægen beslutter, at De skal stoppe med Vimpatbehandlingen, vil lægen gradvist nedsætte dosis.
English: Propylene glycol (E1520): This medicine contains 2.14 mg propylene glycol in each ml.
Danish: • Propylenglycol (E 1520): Dette lægemiddel indeholder 2,14 mg propylenglycol pr. ml.
English: 1 x 20 ml solution for infusion 200 mg/20 ml
Danish: 1 x 20 ml infusionsvæske, opløsning 200 mg/20 ml
English: Table: Start of the treatment (the first 4 weeks)
Danish: Tabel: Behandlingsstart (de første 4 uger) Uge Æske, der skal bruges
English: The active substance is lacosamide.
Danish: • Aktivt stof: lacosamid.
English: Additional side effects when given as an intravenous infusion
Danish: Yderligere bivirkninger, når lægemidlet gives som en intravenøs infusion Der kan være lokale bivirkninger.
English: Vimpat 10 mg/ml syrup is a slightly viscous clear, colourless to yellow-brown liquid.
Danish: • Vimpat-syrup 10 mg/ml er en lidt tyktflydende, klar opløsning med svag gulbrun farve.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients water for injections sodium chloride hydrochloric acid (for pH adjustment)
Danish: Vand til injektionsvæsker Natriumchlorid Saltsyre (til justering af pH)
English: It is not recommended to take Vimpat if you are pregnant or breast-feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known.
Danish: Det frarådes at tage Vimpat, hvis De er gravid eller ammer, da Vimpats virkning på graviditeten og det ufødte barn eller det nyfødte barn ikke er kendt.
English: Vimpat 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: Vimpat-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: Masking flavour (contains propylene glycol (E1520), aspartame (E951), acesulfame potassium (E950), maltol, deionised water) purified water
Danish: Maskerende aroma (indeholder propylenglycol (E1520), aspartam (E 951), acesulfamkalium (E 950), maltol, demineraliseret vand)
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, the 14, 28, 56 and 168 packs are available with standard PVC/PVDC blisters sealed with an aluminium foil, the 60 packs are available in HDPE bottles with a child-resistant closure.
Danish: Pakningerne med 14 x 1 og 56 x 1 filmovertrukket tablet fås som PVC/PVDC perforeret enkeltdosisblister med aluminiumsfolie, pakningerne med 14, 28, 56 og 168 tabletter fås som standard PVC/PVDC blister med aluminiumsfolie, pakningerne med 60 tabletter fås i HDPEbeholder med børnesikret lukning.
English: Use Vimpat twice each day - once in the morning and once in the evening.
Danish: • Brug Vimpat to gange hver dag - en gang om morgenen og en gang om aftenen.
English: If you weigh 50 kg or more, your doctor may decide to start Vimpat 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 Vimpat med en enkelt ”støddosis” på 200 mg (20 ml).
English: The doctor will prescribe the formulation that is best suited to them.
Danish: Lægen vil ordinere det Vimpat produkt, der passer bedst til barnet.
English: Children and adolescents weighing less than 50 kg
Danish: Børn og unge, der vejer mindre end 50 kg
English: Vimpat 10 mg/ml syrup lacosamide
Danish: Vimpat 10 mg/ml syrup lacosamid
English: Use the measuring cup provided in the carton box.
Danish: • Brug målekoppen i æsken.
English: Use the oral syringe provided in the carton box.
Danish: • Brug den orale sprøjte i æsken.
English: Use the measuring cup provided in this pack.
Danish: • Brug målebægeret i denne pakning 1.
English: Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Danish: Vimpat 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 usual starting dose of Vimpat is 50 mg (5 ml) twice a day.
Danish: Den sædvanlige startdosis af Vimpat er 50 mg (5 ml) to gange om dagen.
English: The treatment with Vimpat may also start with a dose of 100 mg of Vimpat twice a day.
Danish: Behandlingen med Vimpat kan også opstartes med en dosis på 100 mg Vimpat to gange dagligt.
English: Vimpat syrup contains propylene glycol (E1520).
Danish: Vimpat-syrup indeholder propylenglycol (E 1520).
English: UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00
Danish: Luxembourg/Luxemburg UCB Pharma SA/NV Tél/Tel: + 32/(0)2 559 92 00
English: 14 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablet 14 x 1 film-coated tablet 28 film-coated tablets 60 film-coated tablets
Danish: 14 filmovertrukne tabletter 56 filmovertrukne tabletter 56 x 1 filmovertrukket tablet 14 x 1 filmovertrukket tablet 28 filmovertrukne tabletter 60 filmovertrukne tabletter
English: 14 film-coated tablets 56 film-coated tablets 168 film-coated tablets 56 x 1 film-coated tablet 14 x 1 film-coated tablet 28 film-coated tablets 60 film-coated tablets
Danish: 14 filmovertrukne tabletter 56 filmovertrukne tabletter 168 filmovertrukne tabletter 56 x 1 filmovertrukket tablet 14 x 1 filmovertrukket tablet 28 filmovertrukne tabletter 60 filmovertrukne tabletter
English: If you have taken more Vimpat than you should, contact your doctor immediately.
Danish: Hvis De har taget for meget Vimpat Kontakt straks lægen, hvis De har taget for meget Vimpat.
English: Your doctor may also prescribe a starting dose of 100 mg (10 ml) of Vimpat twice a day.
Danish: Lægen kan også ordinere en startdosis på 100 mg (10 ml) Vimpat to gange om dagen.
English: Multipack: 168 (3 packs of 56) film-coated tablets
Danish: Multipakning: 168 (3 pakninger á 56) filmovertrukne tabletter
English: Take Vimpat twice each day - once in the morning and once in the evening.
Danish: • Tag Vimpat to gange om dagen - en gang om morgenen og en gang om aftenen.
English: The usual starting dose of Vimpat is 50 mg twice a day.
Danish: Den sædvanlige startdosis af Vimpat er 50 mg to gange dagligt.
English: EU/1/08/470/005 EU/1/08/470/006 EU/1/08/470/007 EU/1/08/470/008 EU/1/08/470/009 EU/1/08/470/010 EU/1/08/470/011 EU/1/08/470/012 EU/1/08/470/020 EU/1/08/470/021 EU/1/08/470/022 EU/1/08/470/023 EU/1/08/470/024 EU/1/08/470/025 EU/1/08/470/026 EU/1/08/470/027 EU/1/08/470/028 EU/1/08/470/029 EU/1/08/470/030 EU/1/08/470/031 EU/1/08/470/032 EU/1/08/470/033 EU/1/08/470/034 EU/1/08/470/035
Danish: EU/1/08/470/001 EU/1/08/470/002 EU/1/08/470/003 EU/1/08/470/004 EU/1/08/470/005 EU/1/08/470/006 EU/1/08/470/007 EU/1/08/470/008 EU/1/08/470/009 EU/1/08/470/010 EU/1/08/470/011 EU/1/08/470/012 EU/1/08/470/020 EU/1/08/470/021 EU/1/08/470/022 EU/1/08/470/023 EU/1/08/470/024 EU/1/08/470/025 EU/1/08/470/026 EU/1/08/470/027 EU/1/08/470/028 EU/1/08/470/029 EU/1/08/470/030 EU/1/08/470/031 EU/1/08/470/032 EU/1/08/470/033 EU/1/08/470/034 EU/1/08/470/035
English: Multipack: 168 (3 packs of 56) film-coated tablets.
Danish: Multipakning: 168 (3 pakninger á 56) filmovertrukne tabletter.
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.