FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.2 Indications for use, specifying the target species
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Får
English: For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Danish: Aktiv immunisering af får fra 2,5-månedersalderen til forebyggelse af viræmi* og til reduktion af kliniske symptomer forårsaget af bluetonguevirus serotype 8.
English: For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.
Danish: Aktiv immunisering af kvæg fra 2,5-månedsalderen til forebyggelse af viræmi* forårsaget af bluetonguevirus serotype 8.
English: Pregnancy and lactation:
Danish: Drægtighed og diegivning
English: There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
Danish: Anvendelse af vaccinen hos diegivende får og køer har ingen negativ indvirkning på mælkeudbyttet.
English: Duration of immunity: 1 year after the second dose.
Danish: Revaccination: 1 dosis om året.
English: WITHDRAWAL PERIOD(S)
Danish: 10. TILBAGEHOLDELSESTID
English: Then drink some water.
Danish: Drik derefter lidt vand.
English: Eating less than usual.
Danish: • Spiser mindre end normalt.
English: Do not try to drive.
Danish: Forsøg ikke at køre bil.
English: This is because we do not yet know whether it will work and whether it is safe for children in this age group.
Danish: Dette skyldes, at vi endnu ikke ved, om det virker og om det er sikkert for børn i denne aldersgruppe.
English: Make sure it is fixed well in place.
Danish: Sørg for at den er ordentligt fastgjort.
English: The duration of the treatment was up to 121 weeks depending on the response.
Danish: Behandlingsvarigheden var op til 121 uger, afhængigt af responset.
English: It is given over 15 to 60 minutes.
Danish: Den gives over 15 til 60 minutter.
English: However, these may then spread to larger areas on both sides of your brain.
Danish: Anfaldene kan dog spredes til større områder i begge sider af hjernen.
English: A worsening of your disease can also harm your baby.
Danish: En forværring af Deres sygdom kan også skade Deres barn.
English: You do not need to remove the adaptor after use.
Danish: De behøver ikke at fjerne adapteren efter brug.
English: Elderly (over 65 years of age)
Danish: Ældre (over 65 år)
English: Your doctor will tell you whether you need all 4 packages.
Danish: Lægen vil informere Dem, om De har brug for alle 4 æsker.
English: you are often dizzy or fall over.
Danish: • De ofte bliver svimmel eller falder.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør præparatet anvendes straks.
English: The rates were also similar to those observed in the overall population.
Danish: Raterne svarede også til dem, som blev set i den totale population.
English: Food does not affect the rate and extent of absorption.
Danish: Fødevarer har ingen effekt på graden og omfanget af absorption.
English: Your doctor will decide for how many days you will have infusions.
Danish: • Lægen vil beslutte, hvor mange dage De skal have infusioner.
English: The potential risk for humans is unknown.
Danish: Risikoen for mennesker kendes ikke.
English: How much to take
Danish: Hvor meget De skal tage
English: The study consisted of an 8-week baseline period followed by a 6-week titration period.
Danish: Studiet bestod af en 8 ugers baselineperiode, efterfulgt af en 6 ugers titreringsperiode.
English: TOTAL daily dose
Danish: TOTAL daglig dosis
English: An increased variability in exposure was also observed.
Danish: Der blev også observeret forøget foranderlighed i eksponering.
English: These medicines are used to treat epilepsy.
Danish: Disse lægemidler bruges til behandling af epilepsi.
English: 3 years After first opening: 2 months.
Danish: Efter åbning: 2 måneder.
English: If women decide to become pregnant, the use of this product should be carefully re-evaluated.
Danish: Hvis kvinder beslutter sig for at blive gravide, bør anvendelsen af dette præparat nøje genovervejes.
English: The packages are marked with ‘week 1 (2, 3 or 4)'.
Danish: Pakningerne er mærket med ‘uge 1 (2, 3 eller 4)'.
English: Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant.
Danish: Søg omgående råd fra Deres læge, hvis De bliver gravid eller planlægger at blive gravid.
English: Therefore, starting or ending treatment with these enzyme inducers should be done with caution.
Danish: Derfor bør opstart eller afslutning af behandlingen med disse enzym-inducere udføres med forsigtighed.
English: The body weight normalized difference is 26 and 23 %, respectively.
Danish: Forskellen i kropsvægt er henholdsvis 26 og 23 %.
English: Moreover, effective antiepileptic therapy must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.
Danish: Endvidere må effektiv antiepileptisk behandling ikke afbrydes, da en forværring af sygdommen er skadelig for både moderen og fostret.
English: Children under 4 years
Danish: Børn under 4 år
English: Your doctor will show you how to use the oral syringe, before you use it for the first time.
Danish: Lægen vil vise Dem, hvordan De bruger den orale sprøjte, inden den bruges for første gang.
English: This belongs to a group of medicines called “antiepileptic medicines”.
Danish: Dette tilhører en gruppe lægemidler kaldet "antiepileptiske lægemidler".
English: More details are provided in the table below.
Danish: Flere detaljer er angivet i tabellen nedenfor.
English: Syncope(2) Coordination abnormal
Danish: Synkope(2) Abnorm koordination
English: Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
Danish: • Hold flasken på hovedet i den ene hånd, og brug den anden hånd til at fylde den orale sprøjte.
English: You will usually start by taking a low dose each day and your doctor will slowly increase this over a number of weeks.
Danish: De starter som regel ved at tage en lav dosis hver dag, og lægen vil langsomt øge dette i løbet af et par uger.
English: Patients should not take a double dose.
Danish: Patienter må ikke tage en dobbelt dosis.
English: Subsequent dose adjustments should be performed according to individual response and tolerability as described above.
Danish: Efterfølgende dosisjusteringer skal ske i henhold til individuelt respons og tolerabilitet som anført ovenfor.
English: This is partly related to lower body weight.
Danish: Dette skyldes delvist lavere kropsvægt.
English: After intravenous administration, Cmax is reached at the end of infusion.
Danish: Efter intravenøs administration nås Cmax ved slutningen af infusionen.
English: In this type of epilepsy, fits first affect only one side of your brain.
Danish: • I denne type epilepsi påvirker anfaldene i begyndelsen kun den ene side af hjernen.
English: Excipients which may cause intolerance
Danish: Hjælpestoffer, der kan forårsage intolerance
English: This is to prevent your epilepsy from coming back again or becoming worse.
Danish: Formålet er at forhindre, at Deres epilepsi vender tilbage eller bliver værre.
English: It is therefore recommended to initiate treatment with the syrup and switch to tablets, if desired.
Danish: Det anbefales derfor at indlede behandling med syrup og skifte til tabletter, hvis det ønskes.
English: Component of a multipack, can't be sold separately.
Danish: Del af multipakning, må ikke sælges separat.
English: Conversion to or from oral and intravenous administration can be done directly without titration.
Danish: Omstilling til eller fra oral og intravenøs administration kan ske direkte uden titrering.
English: Apart from the hypertrophy of hepatocytes, no other histopathologic changes were observed.
Danish: Bortset fra hypertrofi af hepatocytter blev der ikke observeret andre histopatologiske forandringer.
English: Lacosamide should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Danish: Lacosamid bør ikke anvendes under graviditet, medmindre det er strengt nødvendigt (hvis fordelene for moderen klart opvejer de mulige risici for fosteret).
English: Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Danish: • Overdreven følelse af velvære, De ser og/eller hører ting, der ikke er der;
English: The total daily dose and twice daily administration should be maintained.
Danish: Den totale daglige dosis og administration to gange daglig bør fastholdes.
English: The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be estimated from available data).
Danish: Hyppigheden er defineret som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) og ikke kendt (kan ikke estimeres ud fra forhåndværende data).
English: Try to use it at about the same time each day.
Danish: • Prøv at bruge det på omtrent samme tid hver dag.
English: First dose (in the morning)
Danish: Første dosis (om morgenen)
English: Instead take Lacosamide UCB at the next time that you would normally take it.
Danish: I stedet skal De tage Lacosamide UCB næste gang, at De normalt ville tage den.
English: The IV infusion is usually used for a short time when you cannot take the medicine by mouth.
Danish: • IV-infusionen bruges normalt i en kort periode, når De ikke kan tage medicinen igennem munden.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lacosamide.
Danish: Mekanismen bag denne risiko er ikke kendt og de forhåndenværende data udelukker ikke muligheden for en forøget risiko for lacosamid.
English: No second- or higher degree AV Block was seen in these studies.
Danish: Der blev ikke observeret nogen AV-blok af anden grad eller højere i disse studier.
English: When prescribing the syrup the dose should be expressed in volume (ml) rather than weight (mg).
Danish: Ved ordination af syrup bør dosis udtrykkes i volumen (ml) snarere end vægt (mg).
English: After first opening, bottle may be used for up to 2 months.
Danish: Efter åbning kan flaskens indhold bruges i op til 2 måneder.
English: Not recommended
Danish: Ikke anbefalet
English: If you have any of these thoughts at any time, tell your doctor straight away.
Danish: Hvis De på noget tidspunkt får nogen af disse tanker, skal De straks fortælle det til lægen.
English: Some were dose-related and could be alleviated by reducing the dose.
Danish: Nogle var dosisrelaterede og kunne lindres ved at nedsætte dosis.
English: Small amounts (0.5-2 %) of additional metabolites were found in the urine.
Danish: Små mængder (0,5-2 %) af øvrige metabolitter blev fundet i urinen.
English: A sore throat, high temperature and getting more infections than usual.
Danish: • Øm hals, høj temperatur og får flere infektioner end normalt.
English: Second dose (in the evening)
Danish: Anden dosis (om aftenen)
English: Clinical efficacy and safety Adult population
Danish: Klinisk virkning og sikkerhed Voksne
English: How much to use
Danish: Hvor meget De skal bruge
English: Outer carton / bottle
Danish: Yderkarton / flaske
English: (3) Reported in open-label studies.
Danish: (3) Rapporteret i open-label (ikke-blindede) studier.
English: Irritability Feeling drunk
Danish: Irritabilitet Følelse af at være beruset
English: Any unused solution should be discarded (see section 3).
Danish: Al ubrugt opløsning skal kasseres (se punkt 3).
English: (4) Local adverse reactions associated with intravenous administration.
Danish: (4) Lokale bivirkninger associeret med intravenøs administration.
English: Known second- or third-degree atrioventricular (AV) block.
Danish: Kendt anden eller tredje grads atrioventrikulær (AV) blok.
English: Risk related to lacosamide
Danish: Risiko relateret til lacosamid
English: In rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying proarrhythmic conditions.
Danish: I sjældne tilfælde førte disse hændelser til asystoli, hjertestop og død hos patienter med underliggende proarytmiske tilstande.
English: Try to take it at about the same time each day.
Danish: • Prøv at tage det på omtrent samme tidspunkt hver dag.
English: In the treated population, an increase in malformations has been noted with polytherapy, however, the extent to which the treatment and/or the illness is responsible has not been elucidated.
Danish: Hos den behandlede befolkning er en stigning i misdannelser set ved polyterapi, men i hvilket omfang behandlingen og/eller sygdommen er ansvarlig er ikke blevet belyst.
English: Data generally suggest that lacosamide has a low interaction potential.
Danish: Data tyder generelt på, at lacosamid har lavt potentiale for interaktion.
English: 40789 Monheim am Rhein GERMANY
Danish: 40789 Monheim am Rhein TYSKLAND
English: This major metabolite has no known pharmacological activity.
Danish: Denne hovedmetabolit har ingen kendt farmakologisk aktivitet.
English: Multiorgan hypersensitivity reactions
Danish: Multiorgan-overfølsomhedsreaktioner
English: Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.
Danish: Lægen kan ordinere en anden dosis, hvis De har problemer med Deres nyrer eller lever.
English: Opening date (only for the outer carton)
Danish: Åbningsdato (kun for den ydre pakning)
English: PHARMACEUTICAL FORM Syrup.
Danish: LÆGEMIDDELFORM Syrup.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be fully elucidated.
Danish: Den præcise mekanisme, hvormed lacosamid udøver en antiepileptisk effekt hos mennesker, mangler stadig at blive fuldt ud belyst.
English: The plasma concentration increases with an accumulation factor of approximately 2.
Danish: Plasmakoncentrationen stiger med en akkumulationsfaktor på ca. 2.
English: The usual dose that may be taken per day for each of the first 4 weeks of treatment is shown in the following table.
Danish: Den sædvanlige dosis, som kan tages dagligt i hver af de første 4 behandlingsuger, fremgår af nedenstående tabel.
English: Close the bottle with the plastic screw cap (you do not need to remove the adaptor).
Danish: • Luk flasken ved at skrue plastik hætten på (det er ikke nødvendigt at fjerne adapteren).
English: When you change from the infusion to taking the medicine by mouth (or the other way around) the total amount you take each day and how often you take it stays the same.
Danish: Når De skifter fra infusionen til at tage medicinen gennem munden (eller omvendt), forbliver den dosis, De tager hver dag, og hvor ofte De tager den,uændret.
English: These differences between elderly and younger adult patients were similar to those observed in the active comparator group.
Danish: Disse forskelle mellem ældre og yngre voksne patienter svarede til dem, der blev observeret i armen med aktiv komparator.
English: Pharmacokinetics in special patient groups
Danish: Farmakokinetikken i særlige patientgrupper
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Derfor bør patienterne overvåges for, om de får tegn på selvmordstanker og -adfærd, og passende behandling bør overvejes.
English: In juvenile rats and dogs, the types of toxicity do not differ qualitatively from those observed in adult animals.
Danish: Hos unge rotter og hunde afviger typerne af toksicitet ikke kvalitativt fra dem hos voksne dyr.
English: These transient changes started in the same concentration range as after maximum recommended clinical dosing.
Danish: Disse kortvarige ændringer begyndte i samme koncentrationsområde som efter den maksimale anbefalede kliniske dosering.
English: • Fever (pyrexia);
Danish: • Feber (pyreksi);
English: No dose reduction is necessary in elderly patients.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter.
English: Additional side effects when given as an intravenous infusion There may be local side effects.
Danish: Yderligere bivirkninger, når lægemidlet gives som en intravenøs infusion Der kan være lokale bivirkninger.
English: Since higher exposure levels could not be tested in animals due to maternal toxicity, data are insufficient to fully characterise the embryofetotoxic and teratogenic potential of lacosamide.
Danish: Eftersom højere eksponeringsniveauer ikke kan testes i dyr på grund af maternel toksicitet, er data for utilstrækkelige til fuldstændigt at beskrive lacosamids embryoføtotoksiske og teratogene potentiale.
English: 95 % of the dose is excreted in the urine as lacosamide and metabolites.
Danish: 95 % af dosis udskilles i urinen som lacosamid og metabolitter.
English: Irritability, trouble sleeping, depression;
Danish: • Irritabilitet, søvnbesvær, depression;
English: They usually start treatment with the syrup and only change to tablets if they are able to take tablets and get the correct dose with the different tablet strengths.
Danish: Børn starter normalt behandling med syruppen og skifter kun til tabletter, hvis de kan sluge tabletter og få den korrekte dosis med de forskellige tabletstyrker.
English: (2) See Description of selected adverse reactions.
Danish: (2) Se Beskrivelse af udvalgte bivirkninger.
English: The plasma concentration increases proportionally with dose after oral (100-800 mg) and intravenous (50-300 mg) administration.
Danish: Plasmakoncentrationen stiger proportionalt med dosis efter oral (100-800 mg) og intravenøs (50-300 mg) administration.
English: There is no specific antidote for overdose with lacosamide.
Danish: Der findes ingen specifik antidot mod overdosering med lacosamid.
English: If multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued.
Danish: Hvis der er mistanke om en multiorgan-overfølsomhedsreaktion, bør lacosamid seponeres.
English: Lacosamide therapy can be initiated with either oral or intravenous administration.
Danish: Behandling med lacosamid kan initieres med enten oral eller intravenøs administration.
English: However, a higher incidence (≥ 5 % difference) of fall, diarrhoea and tremor has been reported in elderly patients compared to younger adult patients.
Danish: Dog blev der rapporteret en højere incidens (≥ 5 % forskel) af fald, diarré og tremor hos ældre patienter sammenlignet med yngre voksne patienter.
English: The most frequent cardiac-related adverse reaction reported in elderly compared to the younger adult population was first-degree AV block.
Danish: Den hyppigst forekommende hjerterelaterede bivirkning, som blev rapporteret hos den ældre population sammenlignet med den yngre voksen population, var første grads AV-blok.
English: Each package has 14 tablets, corresponding to 2 tablets per day for 7 days.
Danish: Hver æske indeholder 14 tabletter, hvilket svarer til 2 tabletter dagligt i 7 dage.
English: They were usually mild to moderate in intensity.
Danish: De var som regel milde til moderate.
English: The dose should be gradually increased until the optimum response is obtained.
Danish: Dosis bør gradvist øges, indtil det optimale respons opnås.
English: The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient.
Danish: Det kan være nødvendigt at justere dosis under nøje overvågning af sygdomsaktiviteten samt potentielle bivirkninger hos patienten.
English: Administration of a loading dose has not been studied in children.
Danish: Administration af en støddosis er ikke undersøgt hos børn.
English: Difficulties in coordinating your movements or walking.
Danish: • Vanskeligheder ved at koordinere Deres bevægelser eller gang.
English: The elimination half-life of lacosamide is approximately 13 hours.
Danish: Halveringstiden for elimination af lacosamid er ca. 13 timer.
English: Shake the bottle well before use.
Danish: Ryst flasken godt før brug.
English: The quality of life assessed by the Pediatric Quality of Life Inventory indicated that subjects in both lacosamide and placebo groups had a similar and stable health-related quality of life during the entire treatment period.
Danish: Den livskvalitet, der blev bedømt af Pediatric Quality of Life Inventory, indikerede, at forsøgspersoner i både lacosamid- og placebo-gruppen havde en lignende og stabil helbredsrelateret livskvalitet i løbet af hele behandlingsperioden.
English: Do not stop taking Lacosamide UCB without talking to your doctor, as your epilepsy may come back again or become worse.
Danish: • Stop ikke med at tage Lacosamide UCB uden først at tale med Deres læge, da Deres epilepsi kan komme tilbage igen eller blive værre.
English: You should continue to take Lacosamide UCB until your doctor tells you to stop.
Danish: De skal fortsætte med at tage Lacosamide UCB, indtil lægen beder Dem om at stoppe.
English: Progesterone concentrations were not affected when the medicinal products were co-administered.
Danish: Progesteronkoncentrationerne blev ikke påvirket, når lægemidlerne blev administreret samtidigt.
English: The renal clearance of lacosamide was only slightly reduced in elderly subjects in this study.
Danish: Lacosamids renale clearance blev kun reduceret i mindre grad hos ældre i dette studie.
English: Such interactions have not been established in vivo but are possible based on in vitro data.
Danish: Sådanne interaktioner er ikke blevet påvist in vivo, men kan, baseret på in vitro-data, forventes.
English: The adjusted absolute difference between treatments was -1.3 % (95 % CI: -5.5, 2.8).
Danish: Den justerede absolutte forskel mellem behandlingerne var -1,3 % (95 % CI: -5,5; 2,8).
English: Therefore, clinically relevant interactions with other medicinal products through competition for protein binding sites are considered unlikely.
Danish: Det anses derfor for usandsynligt, at der er klinisk relevante interaktioner med anden medicin ved konkurrence om proteinbindingssteder.
English: The following information is intended for medical or healthcare professionals only.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale:
English: This dose is called a maintenance dose and will depend on how you respond to Lacosamide UCB.
Danish: Denne dosis kaldes vedligeholdelsesdosis og vil afhænge af, hvordan De reagerer på Lacosamide UCB.
English: The decrease in non-renal clearance in the patients of the study was estimated to give a 20 % increase in the AUC of lacosamide.
Danish: Det blev vurderet, at den nedsatte ikke-renale clearance hos patienterne, der indgik i undersøgelsen, ville give en stigning på 20 % i lacosamids AUC.
English: The pharmacokinetics is dose-proportional and constant over time, with low intra- and inter-subject variability.
Danish: Farmakokinetikken er proportional med dosis og konstant over tid med lav intra- og interindividuel variation.
English: You have been given this medicine to lower the number of fits (seizures) you have.
Danish: • De har fået dette lægemiddel for at nedbringe antallet af anfald (krampeanfald) De oplever.
English: Patients should be counselled to seek immediate medical advice if these symptoms occur.
Danish: Patienterne bør rådes til straks at søge lægehjælp, hvis nogen af disse symptomer opstår.
English: Double vision (diplopia).
Danish: • Dobbeltsyn (diplopi).
English: This will be until you reach a maintenance dose.
Danish: Dette gøres indtil De når en vedligeholdelsesdosis.