FrancophonIA/ELRC3.0 huggingface dataset:
English: Minimum effective doses should be given, and monotherapy whenever possible should be preferred at least during the first three months of pregnancy.
Danish: Den mindste effektive dosis bør gives, og om muligt bør der vælges monoterapi - i hvert fald i de første tre måneder af graviditeten.
English: Hyponatraemia is asymptomatic in most cases, however, it may be accompanied by clinical symptoms like worsening of seizures, confusion, decreased consciousness.
Danish: Hyponatriæmi er asymptomatisk i det fleste tilfælde, men det kan dog være ledsaget af kliniske symptomer så som tiltagende anfald, konfusion, bevidsthedssvækkelse.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til human brug skal en opdateret RMP fremsendes samtidig med den efterfølgende periodiske sikkerhedsopdateringsrapport (PSUR).
English: • The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.
Danish: • Øvrige indholdsstoffer: Povidon K29/32, croscarmellosenatrium og magnesiumstearat.
English: POSSIBLE SIDE EFFECTS Like all medicines, Exalief can cause side effects, although not everybody gets them.
Danish: BIVIRKNINGER Exalief kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Therefore, whenever possible, subjects of Han Chinese and Thai origin should be screened for this allele before starting treatment with carbamazepine or chemically-related compounds.
Danish: Derfor bør personer af hankinesisk eller thailandsk oprindelse om muligt screenes for denne allel, før der indledes behandling med carbamazepin eller kemisk beslægtede stoffer.
English: Known second or third degree atrioventricular (AV) block.
Danish: Kendt 2. eller 3. grads atrioventrikulært blok (AV-blok).
English: 20 tablets 30 tablets 60 tablets 90 tablets
Danish: 20 tabletter 30 tabletter 60 tabletter 90 tabletter
English: Your doctor may need to adjust the dose.
Danish: Måske skal lægen justere dosis.
English: Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Danish: Undersøgelser har vist, at der er en øget risiko for misdannelser hos børn af kvinder, der tager medicin mod epilepsi.
English: 400 mg dose once daily for one or two weeks, before increasing to the maintenance dose.
Danish: 400 mg dosis en gang dagligt i en eller to uger, inden der øges til vedligeholdelsesdosen.
English: If women receiving eslicarbazepine acetate become pregnant or plan to become pregnant, the use of Exalief should be carefully re-evaluated.
Danish: Hvis en kvinde i behandling med eslicarbazepinacetat bliver gravid eller planlægger graviditet, skal brug af Exalief atter overvejes grundigt.
English: The usual maintenance dose is 800 mg once daily.
Danish: Den sædvanlige vedligeholdelsesdosis er 800 mg en gang dagligt.
English: Exalief may decrease the effectiveness of hormonal contraceptives.
Danish: Exalief kan nedsætte virkningen af hormonelle kontraceptiva.
English: • Burning sensation
Danish: • Brændende fornemmelse
English: • you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block)
Danish: • hvis De lider af en bestemt type rytmeforstyrrelser i hjertet (2. eller 3. grads atrioventrikulært blok (AV-blok).
English: A small number of people being treated with anti-epileptics have had thoughts of harming or killing themselves.
Danish: Et lille antal patienter, der får antiepileptika, har haft tanker om at skade sig selv eller begå selvmord.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelse (Modul 1.8.1), er på plads og fungerer, før og mens produktet markedsføres.
English: It is important that your treatment is completed as advised by your doctor or your symptoms may get worse.
Danish: Det er vigtigt at fuldføre den behandling, lægen har ordineret, da symptomerne ellers kan forværres.
English: Studies in animals have shown reproductive toxicity (see Fertility).
Danish: Reproduktionstoksicitet er set i dyrestudie (se Fertilitet).
English: • Do not take oxcarbazepine (a medicine used to treat epilepsy) with Exalief, as it is not known whether it is safe to take these medicines together.
Danish: • De må ikke tage oxcarbazepin (medicin mod epilepsi) sammen med Exalief, da det er uvist, om det er sikkert at tage de to lægemidler samtidig.
English: Menstruation irregular
Danish: Uregelmæssig menstruation
English: Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Danish: Risiko forbundet med epilepsi og antiepileptika generelt Det er påvist, at hos børn af kvindelige epileptikere fordobles eller tredobles prævalensen af misdannelser i forhold til forekomsten på ca. 3 % hos befolkningen generelt.
English: Patients should be counselled regarding the possibility of an increased risk of malformations and given the opportunity to antenatal screening.
Danish: Patienten bør rådgives om den øgede risiko for misdannelser og få tilbudt antenatal screening.
English: A study in patients with mild to severe renal impairment showed that clearance is dependent on renal function.
Danish: Et studie med patienter med let til alvorligt nedsat nyrefunktion viste, at clearance afhænger af nyrefunktionen.
English: Hypertension, hypotension, orthostatic hypotension
Danish: Hypertension, hypotension, ortostatisk hypotension
English: Hyponatraemia has been reported as an adverse reaction in less than 1% of patients treated with Exalief.
Danish: Hyponatriæmi er indberettet som en bivirkning hos færre end 1 % af de patienter, der fik Exalief.
English: Furthermore, serum sodium levels should be determined if clinical signs of hyponatraemia occur.
Danish: Endvidere bør serumnatrium bestemmes, hvis der opstår kliniske tegn på hyponatriæmi.
English: • Poor memory or forgetfulness
Danish: • Dårlig hukommelse eller glemsomhed
English: • Faster, slower or irregular heart beat
Danish: • Hurtigere, langsommere eller uregelmæssig puls
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Danish: Patienten (og patientens omsorgspersoner) bør rådgives om at søge lægehjælp, hvis der opstår tegn på selvmordstanker og -adfærd.
English: Taking Exalief with food and drink Exalief tablets may be taken with or without food.
Danish: Brug af Exalief sammen med mad og drikke Exalief tabletter kan tages alene eller i forbindelse med et måltid.
English: • you suffer from a heart disease such as heart failure or heart attack.
Danish: • hvis De har dårligt hjerte, f.eks. hjertesvigt eller hjerteanfald.
English: As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn.
Danish: Til forebyggelse af dette bør der for en sikkerheds skyld gives K1-vitamin til kvinder i de sidste uger af graviditeten og til nyfødte.
English: If you have kidney problems you will usually be given a lower dose of Exalief.
Danish: Hvis De har dårlige nyrer, vil De normalt få en lavere dosis Exalief.
English: Presence of HLA-B*1502 allele in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing Stevens-Johnson syndrome (SJS) when treated with carbamazepine.
Danish: Forekomst af HLA-B*1502-allel hos personer af hankinesisk eller thailandsk oprindelse har vist sig at være tæt forbundet med risikoen for at få Stevens-Johnsons syndrom (SJS) under behandling med carbamazepin.
English: • you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels
Danish: • hvis De lider af forvirring, tiltagende anfald eller bevidsthedssvækkelse, hvilket kan være tegn på et lavt saltindhold i blodet.
English: Bioavailability may be assumed as high because the amount of metabolites recovered in urine corresponded to more than 90% of an eslicarbazepine acetate dose.
Danish: Biotilgængeligheden formodes at være høj, da mængden af metabolitter, der blev genfundet i urin, svarede til over 90 % af dosen af eslicarbazepinacetat.
English: The binding of warfarin, diazepam, digoxin, phenytoin and tolbutamide was not significantly affected by the presence of eslicarbazepine.
Danish: Bindingen af warfarin, diazepam, digoxin, phenytoin og tolbutamid blev ikke påvirket i signifikant omfang af tilstedeværelsen af eslicarbazepin.
English: No effects on F1 fertility parameters were observed in rats and mice.
Danish: Der sås ingen påvirkning af F1-fertilitetsparametre hos rotter og mus.
English: In vitro studies have shown that plasma protein binding was not relevantly affected by the presence of warfarin, diazepam, digoxin, phenytoin and tolbutamide.
Danish: In vitro-studier har vist, at plasmaproteinbindingen ikke påvirkes i relevant omfang af tilstedeværelsen af warfarin, diazepam, digoxin, phenytoin og tolbutamid.
English: PVC/ALU blister
Danish: PVC/ALU-blisterkort
English: Folic acid supplementation is recommended before and during pregnancy.
Danish: Det anbefales at give folinsyretilskud før og under graviditet.
English: Should your doctor decide to stop your treatment with Exalief your dose will usually be reduced gradually.
Danish: Hvis lægen beslutter at stoppe behandlingen med Exalief, skal doseringen sædvanligvis nedtrappes.
English: The safety and efficacy of Exalief in children below 18 years has not yet been established.
Danish: Pædiatrisk population Exaliefs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: A meta-analysis of randomised placebo controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Danish: En metaanalyse af randomiserede placebokontrollerede studier med antiepileptika har også vist en svagt øget risiko for selvmordstanker og -adfærd.
English: • Nail or skin changes (e.g. red skin)
Danish: • Forandringer i negle eller hud (f.eks. rød hud)
English: • Blood tests showing that you have low levels of salts or sodium in your blood or a reduction in red blood cells
Danish: • Blodprøver, der viser et lavt indhold af salte eller natrium eller et fald i de røde blodlegemer
English: There was no effect on the R-warfarin pharmacokinetics or on coagulation.
Danish: Der sås ingen virkning på Rwarfarins farmakokinetik eller på koagulationen.
English: Risk Management plan
Danish: Risikostyringsprogram (RMP)
English: A population pharmacokinetics analysis of phase III studies in epileptic adult patients indicated that concomitant administration with valproate or levetiracetam did not affect the exposure to eslicarbazepine but this has not been verified by conventional interaction studies.
Danish: En populationsfarmakokinetisk analyse af fase III-studier med voksne epilepsipatienter indikerede, at samtidig administration af valproat eller levetiracetam ikke påvirkede eksponeringen for eslicarbazepin, men dette er ikke verificeret i konventionelle interaktionsundersøgelser.
English: Very common side effects are: • Feeling dizzy or sleepy
Danish: Meget almindelige bivirkninger: • Svimmelhed eller søvnighed
English: • Weight loss and general ill health (Cachexia)
Danish: • Vægttab og generelt dårligt helbred (kakeksi)
English: However, due to inter-individual variability in the interaction, special attention on monitoring of INR should be performed the first weeks after initiation or ending concomitant treatment of warfarin and eslicarbazepine acetate.
Danish: På grund af interindividuel variation i interaktionen skal INR dog monitoreres i de første uger efter indledning eller afslutning af samtidig behandling med warfarin og eslicarbazepinacetat.
English: Bleeding disorders in the newborn caused by antiepileptic medicinal products have been reported.
Danish: Der er indberettet blødningsforstyrrelser, der skyldes antiepileptika, hos nyfødte.
English: Eslicarbazepine acetate does not affect its own metabolism or clearance.
Danish: Eslicarbazepinacetat påvirker ikke sin egen metabolisme eller clearance.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic active substances in several indications.
Danish: Der er indberettet selvmordstanker og -adfærd hos patienter i behandling med antiepileptika på en række forskellige indikationer.
English: * In patients concomitantly treated with carbamazepine and eslicarbazepine acetate in placebo-controlled studies, diplopia, abnormal coordination and dizziness were reported more frequently.
Danish: * Hos patienter i samtidig behandling med carbamazepin og eslicarbazepinacetat i placebokontrollerede studier blev diplopi, abnorm koordination og svimmelhed indberettet hyppigere.
English: Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia (11.4% of subjects with concomitant carbamazepine, 2.4% of subjects without concomitant carbamazepine), abnormal coordination (6.7% with concomitant carbamazepine, 2.7% without concomitant carbamazepine), and dizziness (30.0% with concomitant carbamazepine, 11.5% without concomitant carbamazepine).
Danish: Resultater fra studier med patienter viste, at samtidig behandling øger risikoen for følgende bivirkninger: Diplopi (11,4 % hos forsøgspersoner, der samtidig fik carbamazepin, 2,4 % hos forsøgspersoner der ikke samtidig fik carbamazepin), koordinationsbesvær (6,7 % ved samtidig carbamazepin, 2,7 % uden samtidig carbamazepin) og svimmelhed (30,0 % ved samtidig carbamazepin, 11,5 % uden samtidig carbamazepin).
English: Adverse reactions associated with PR interval prolongation (e.g. AV block, syncope, bradycardia) may occur.
Danish: Der kan opstå bivirkninger, som forbindes med forlængelse af PR-intervallet (fx AV-blok, synkope, bradykardi).
English: Eslicarbazepine acetate was evaluated in rats and mice for potential adverse effects on fertility of the parental and F1 generation.
Danish: Eslicarbazepinacetat blev evalueret hos rotter og mus for potentiel negativ påvirkning af fertiliteten hos forældre- og F1-generationen.
English: No change in exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted.
Danish: Der sås ingen ændringer i eksponeringen for carbamazepin eller dets metabolit carbamazepinepoxid.
English: • Tell your doctor if you are taking tricyclic antidepressants e.g. amitriptyline.
Danish: • Fortæl det til lægen, hvis De tager medicin mod depression (tricykliske antidepressiva) som f.eks. amitriptylin.
English: • Numbness and tingling in hands and feet
Danish: • Følelsesløshed og snurren i hænder og fødder
English: Plasma levels of eslicarbazepine acetate usually remain below the limit of quantification, following oral administration.
Danish: Plasmaniveauet af eslicarbazepinacetat forbliver sædvanligvis under kvantificeringsgrænsen efter oral administration.
English: The recommended starting dose is 400 mg once daily which should be increased to 800 mg once daily after one or two weeks.
Danish: Den anbefalede initialdosis er 400 mg en gang dagligt, og den bør øges til 800 mg en gang dagligt efter en eller to uger.
English: In the table below all adverse reactions, which occurred at an incidence greater than placebo and numerically present in more than 1 patient are listed by System Organ Class and frequency: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1,000 to <1/100, rare ≥1/10,000 to <1/1,000.
Danish: Alle bivirkninger, som forekom med en højere incidens end for placebo og hos flere end 1 patient, er anført i nedenstående tabel ud fra systemorganklasse og hyppighed: meget almindelig ≥1/10, almindelig ≥1/100 til <1/10, ikke almindelig ≥1/1.000 til <1/100, sjælden ≥1/10.000 til <1/1.000.
English: On the other hand effective anti-epileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.
Danish: På den anden side må behandlingen med epilepsimedicin ikke afbrydes, da forværring af sygdommen kan skade både mor og barn.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til indtagelse gennem munden.
English: Exalief has been given to you by your doctor to reduce your number of seizures.
Danish: Lægen har ordineret Exalief til Dem for at nedsætte antallet af anfald.
English: Some patients might experience dizziness, somnolence or visual disorders, particularly on initiation of treatment.
Danish: Nogle patienter kan opleve svimmelhed, døsighed eller synsforstyrrelser, særligt ved indledning af behandlingen.
English: Exalief is used in adult patients who are already taking other anti-epileptic medicines and are still experiencing seizures that affect one part of the brain (partial seizure).
Danish: Exalief anvendes til voksne patienter, som allerede får anden medicin mod epilepsi, men stadig får anfald, der påvirker en del af hjernen (fokale anfald).
English: Concomitant use of Exalief with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites.
Danish: Samtidig brug af Exalief og oxcarbazepin frarådes, da dette kan føre til overeksponering for de aktive metabolitter.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage alle de undersøgelser og supplerende aktiviteter, som er beskrevet i pharmacovigilance-planen (ifølge aftalen i risikostyringsprogrammets (RMP) version 4.0, modul 1.8.2 i markedsføringsansøgningen), og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: However, in vitro electrophysiological studies indicate that both eslicarbazepine acetate and its metabolites stabilise the inactivated state of voltage-gated sodium channels, preventing their return to the activated state and thereby sustaining repetitive neuronal firing.
Danish: Imidlertid tyder in vitroelektrofysiologiske studier på, at både eslicarbazepinacetat og dets metabolitter stabiliserer de spændingsafhængige natriumkanalers inaktive tilstand og forhindrer dem i at blive reaktiveret med fortsat repetitiv neuronal fyring til følge.
English: In total, eslicarbazepine and its glucuronide correspond to more than 90% of total metabolites excreted in urine, approximately two thirds in the unchanged form and one third as glucuronide conjugate.
Danish: I alt svarer eslicarbazepin og dets glukuronid til over 90 % af den samlede mængde metabolitter, der udskilles i urinen, ca. 2/3 i uændret form og 1/3 som glukuronidkonjugat.
English: Depending on how you respond to Exalief, your dose may be increased to 1200 mg once daily.
Danish: Afhængig af Deres reaktion på Exalief kan dosis øges til 1200 mg en gang dagligt.
English: Adverse affects observed in animal studies occurred at exposure levels appreciably lower than the clinical exposure levels to eslicarbazepine (the principal and pharmacologically active metabolite of eslicarbazepine acetate).
Danish: De bivirkninger, der blev observeret i dyrestudier, indtraf ved eksponeringsniveau, der var betydeligt lavere end det kliniske eksponeringsniveau for eslicarbazepin (den primære og farmakologisk aktive metabolit af eslicarbazepinacetat).
English: Eslicarbazepine tmax is attained at 2 to 3 h post-dose.
Danish: Eslicarbazepin tmax opnås 2 til 3 timer efter administration.
English: As a risk to the breast-fed child cannot be excluded breastfeeding should be discontinued during treatment with Exalief.
Danish: Da det ikke kan udelukkes, at der foreligger en risiko for brystbarnet, bør amningen ophøre under behandling med Exalief.
English: Exalief belongs to a group of medicines called anti-epileptics used to treat epilepsy, a condition where someone has repeated seizures or fits.
Danish: Exalief hører til en gruppe medicin, der kaldes antiepileptika, som anvendes til behandling af epilepsi, en tilstand med gentagne anfald eller kramper.
English: Oxcarbazepine and felbamate were not allowed as concomitant medicinal products in these studies.
Danish: Oxcarbazepin og felbamat måtte ikke indgå i kombinationsbehandlingen i disse studier.
English: Valproate and levetiracetam
Danish: Valproat og levetiracetam
English: Do not take a double dose to make up for the one you have missed.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: This is so the doctor knows what you have taken.
Danish: Tag pakningen med, så lægen ved, hvad De har taget.
English: In placebo-controlled studies involving 1,192 adult patients with partial-onset seizures (856 patients treated with eslicarbazepine acetate and 336 treated with placebo), 45.3% of patients treated with eslicarbazepine acetate and 24.4% of patients treated with placebo experienced adverse reactions.
Danish: I placebokontrollerede studier omfattende 1.192 voksne patienter med fokale epileptiske anfald (856 patienter behandlet med eslicarbazepinacetat og 336 behandlet med placebo) forekom der bivirkninger hos 45,3 % af de patienter, der fik eslicarbazepinacetat, og hos 24,4 % af de patienter, der fik placebo.
English: Symptoms include cold intolerance, large tongue, thin and brittle fingernails or hair and low body temperature.
Danish: Symptomerne omfatter intolerance over for kulde, stor tunge, tynde og skøre fingernegle eller tyndt/skørt hår samt lav kropstemperatur
English: Do not use Exalief after the expiry date, which is stated on the blister package and the carton after EXP.
Danish: Brug ikke Exalief efter den udløbsdato, der står på blisterpakningen og æsken.
English: Method and route of administration Swallow the tablet with a glass of water.
Danish: Anvendelsesmåde og indgivelsesvej Tabletterne sluges hele med et glas vand.
English: No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures which could have serious consequences for both mother and child.
Danish: Brat seponering af antiepileptika må ikke finde sted, da det kan føre til anfaldsrecidiv, hvilket kunne have alvorlige konsekvenser for både mor og barn.
English: Eslicarbazepine acetate was tested at doses of 400 mg, 800 mg and 1200 mg, once daily.
Danish: Eslicarbazepinacetat blev undersøgt ved doser på 400 mg, 800 mg og 1200 mg en gang dagligt.
English: Genotoxicity studies with eslicarbazepine acetate indicate no special hazards for humans.
Danish: Genotoksicitetsundersøgelser med eslicarbazepinacetat viser ingen særlig risiko for mennesker.
English: Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
Danish: Exalief er indiceret som supplerende antiepileptisk behandling til voksne med fokale epileptiske anfald med eller uden sekundær generalisering.
English: Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible.
Danish: Behandling med flere antiepileptika kan være forbundet med en højere risiko for medfødte misdannelser end monoterapi, og derfor skal der vælges monoterapi, når det er muligt.
English: Prolongations in PR interval have been observed in clinical studies with eslicarbazepine acetate.
Danish: Der er observeret forlænget PR-interval i kliniske studier med eslicarbazepinacetat.
English: Your doctor will work out the correct dose for you.
Danish: Deres læge vil ordinere den dosis, der passer bedst til Dem.