FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with Exalief.
Danish: Derfor kan det være nødvendigt at øge dosis af lægemidler, der især metaboliseres af CYP3A4, når de anvendes samtidig med Exalief.
English: In a fertility study in mice, developmental effects were observed in embryos; however, effects could also result from lower corpora lutea count and thus show impairment of fertility.
Danish: I et fertilitetsstudie med mus observeredes påvirkning af udviklingen hos embryoer, men disse virkninger kunne også skyldes færre corpora lutea og dermed nedsat fertilitet.
English: Eslicarbazepine acetate 800 mg once daily and 1200 mg once daily were significantly more effective than placebo in reducing seizure frequency over a 12-week maintenance period.
Danish: Eslicarbazepinacetat 800 mg en gang dagligt og 1200 mg en gang dagligt var signifikant mere effektive end placebo til at nedsætte hyppigheden af anfald over en 12-ugers vedligeholdelsesperiode.
English: As with other anti-epileptic medicinal products, if Exalief is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency.
Danish: Ligesom det gælder for andre antiepileptika skal seponering af Exalief foregå gradvist for at mindske risikoen for øget anfaldshyppighed.
English: Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects.
Danish: De hyppigst rapporterede misdannelser er hareskår, kardiovaskulære misdannelser og neuralrørsdefekter.
English: • Feeling numb in any part of your body
Danish: • Følelsesløshed et eller flere steder i kroppen
English: Antiepileptic medicinal products may contribute to folic acid deficiency, a possible contributory cause of foetal abnormality.
Danish: Antiepileptiske lægemidler kan medvirke til folinsyremangel, som kan være en medvirkende årsag til fosterskader.
English: Nausea, vomiting, diarrhoea
Danish: Kvalme, opkastning, diarré
English: If you stop taking Exalief
Danish: Hvis De holder op med at tage Exalief
English: Minor metabolites in plasma are R-licarbazepine and oxcarbazepine, which were shown to be active, and the glucuronic acid conjugates of eslicarbazepine acetate, eslicarbazepine, R-licarbazepine and oxcarbazepine.
Danish: De mindre metabolitter, der ses i plasma, er R-licarbazepin og oxcarbazepin, som var aktive, samt glukuronsyrekonjugaterne af eslicarbazepinacetat eslicarbazepin, R-licarbazepin og oxcarbazepin.
English: The pharmacokinetics of eslicarbazepine is linear and dose-proportional in the range 400-1200 mg both in healthy subjects and patients.
Danish: Eslicarbazepins farmakokinetik er lineær og dosisafhængig i intervallet 400-1200 mg hos både raske forsøgspersoner og patienter.
English: If they happen to you stop taking Exalief and tell a doctor or go to a hospital immediately, as you may need urgent medical treatment:
Danish: Hvis De oplever nogle af nedenstående bivirkninger, skal De holde op med tage Exalief og straks kontakte en læge eller skadestuen, da De kan have behov for akut lægehjælp:
English: In patients with pre-existing renal disease leading to hyponatraemia, or in patients concomitantly treated with medicinal products which may themselves lead to hyponatraemia (e.g. diuretics, desmopressin), serum sodium levels should be examined before and during treatment with eslicarbazepine acetate.
Danish: Hos patienter med eksisterende nyresygdom, der medførte hyponatriæmi, eller patienter i samtidig behandling med lægemidler, der i sig selv kan føre til hyponatriæmi (fx diuretika, desmopressin), bør serumkoncentrationen af natrium undersøges før og under behandling med eslicarbazepinacetat.
English: The percentage of subjects with a 50% reduction in seizure frequency over all phase III studies was 19% for placebo, 21% for eslicarbazepine acetate 400 mg, 34% for eslicarbazepine acetate 800 mg and 36% for eslicarbazepine acetate 1200 mg daily.
Danish: Procentdelen af forsøgspersoner med 50 % reduktion i anfaldshyppighed i alle fase III-studier var 19 % for placebo, 21 % for eslicarbazepinacetat 400 mg, 34 % for eslicarbazepinacetat 800 mg og 36 % for eslicarbazepinacetat 1200 mg dagligt.
English: There are no data from the use of eslicarbazepine acetate in pregnant women.
Danish: Der er ingen data fra anvendelse af eslicarbazepinacetat til gravide kvinder.
English: The efficacy and safety of eslicarbazepine acetate has been demonstrated in three phase III double-blind placebo-controlled studies in 1,049 adult patients with partial epilepsy refractory to treatment with one to three concomitant anti-epileptic medicinal products.
Danish: Sikkerhed og virkning af eslicarbazepinacetat er påvist i tre dobbeltblinde, placebokontrollerede fase III-studier omfattende 1.049 voksne patienter med fokal epilepsi, som var upåvirkelig af behandling med et til tre antiepileptika administreret samtidig.
English: Based on individual response, the dose of Exalief may need to be increased and the dose of phenytoin may need to be decreased.
Danish: Afhængigt af den enkelte patients respons kan det være nødvendigt at øge doseringen af Exalief og nedsætte doseringen af phenytoin.
English: Eslicarbazepine acetate and its active metabolites prevented the development of seizures in nonclinical models predictive of anticonvulsant efficacy in man.
Danish: Eslicarbazepinacetat og dets aktive metabolitter forebyggede forekomsten af anfald i ikke-kliniske prædiktive modeller af krampestillende virkning hos mennesker.
English: • Cold limbs
Danish: • Kolde lemmer
English: Evidence of nephrotoxicity was observed in repeated dose toxicity studies in the rat, but was not seen in studies in mice or dogs, and is consistent with an exacerbation of spontaneous chronic progressive nephropathy in this species.
Danish: Der blev påvist nefrotoksicitet i undersøgelser af toksicitet efter gentagne doser hos rotter, mens det ikke forekom i undersøgelser hos mus eller hunde, og dette svarer til forværring af spontan kronisk progredierende nefropati hos denne dyreart.
English: Frequency of hyponatraemia increased with increasing eslicarbazepine acetate dose.
Danish: Hyppigheden af hyponatriæmi steg med stigende doser eslicarbazepinacetat.
English: • Disturbances in the sense of smell and/or tasting
Danish: • Forandringer i lugtesansen og/eller smagssansen
English: • Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures.
Danish: • Bevægelsesforstyrrelser, der stammer fra nervesystemet, hvor musklerne trækker sig sammen, så der forekommer vridende og gentagne bevægelser eller unormale stillinger.
English: Based on individual response, the dose may be increased to 1200 mg once daily (see section 5.1).
Danish: Afhængig af den enkelte patients respons kan dosis øges til 1200 mg en gang dagligt (se pkt.
English: Exalief may make you feel dizzy and/or drowsy, particularly at the beginning of treatment.
Danish: Exalief kan give svimmelhed og/eller sløvhed særligt i begyndelsen af behandlingen.
English: There is no experience regarding the withdrawal of concomitant use of anti-epileptic medicinal products during treatment with Exalief (switch to monotherapy).
Danish: Der er ingen erfaring med seponering af andre antiepileptika, som gives samtidig med behandlingen med Exalief (skift til monoterapi).
English: Children Exalief is not to be given to children and adolescents.
Danish: Børn Exalief må ikke gives til børn under 18 år.
English: If you forget to take Exalief
Danish: Hvis De har glemt at tage Exalief
English: • Crying, feeling depressed, nervous or confused, lack of interest or emotion
Danish: • Gråd, nedtrykthed, nervøsitet eller forvirring, ligegyldighed eller manglende følelser
English: Women of childbearing potential/contraception
Danish: Fertile kvinder/kontraception
English: An increase of the simvastatin dose may be required when used concomitantly with eslicarbazepine acetate.
Danish: Det kan være nødvendigt at øge dosis af simvastatin, når det anvendes samtidig med eslicarbazepinacetat.
English: Rash developed as an adverse reaction in 1.1% of total population treated with Exalief in placebo-controlled add-on studies in epileptic patients.
Danish: Der forekom udslæt som en bivirkning hos 1,1 % af den samlede population, der blev behandlet med Exalief, i placebokontrollerede studier med tillægsbehandling til epilepsipatienter.
English: Based on a structural relationship of eslicarbazepine acetate to tricyclic antidepressants, an interaction between eslicarbazepine acetate and MAOIs is theoretically possible.
Danish: Da eslicarbazepinacetat er strukturelt beslægtet med tricykliske antidepressiva, er interaktion mellem eslicarbazepinacetat og MAO-hæmmere teoretisk mulig.
English: • Weight loss or extreme weight gain
Danish: • Vægttab eller voldsom vægtstigning
English: In the mouse, the overall incidence of major abnormalities and the incidence for major skeletal abnormalities were increased.
Danish: I mus sås en øget samlet incidens af større anomalier og en øget incidens af større skeletale misdannelser.
English: If clinically relevant hyponatraemia develops, Exalief should be discontinued.
Danish: I tilfælde af klinisk relevant hyponatriæmi skal Exalief seponeres.
English: Symptoms include chronic abdominal cramps and diarrhoea or constipation.
Danish: Symptomerne omfatter kroniske mavesmerter og diarré eller forstoppelse.
English: Rare adverse reactions such as bone marrow depression, anaphylactic reactions, severe cutaneous reactions (e.g. Stevens-Johnson Syndrome), systemic lupus erythematosus or serious cardiac arrhythmias did not occur during the placebo-controlled studies of the epilepsy program with eslicarbazepine acetate.
Danish: Der blev ikke observeret sjældne bivirkninger så som knoglemarvsdepression, anafylaktiske reaktioner, svære hudreaktioner (fx Stevens-Johnsons syndrom), systemisk lupus erythematosus eller alvorlig arytmi under placebo-kontrollerede studier som led i epilepsiprogrammet med eslicarbazepinacetat.
English: Central nervous symptoms such as vertigo, walking instability and hemi-paresis have been observed with accidental Exalief overdose.
Danish: Der er observeret symptomer i centralnervesystemet såsom vertigo, usikker gang og hemiparese i forbindelse med en utilsigtet overdosis af Exalief.
English: • Seeing double or blurred vision
Danish: • Dobbeltsyn eller uklart syn
English: The pharmacokinetic profile of eslicarbazepine acetate is unaffected in the elderly patients with creatinine clearance >60 ml/min (see section 4.2).
Danish: Eslicarbazepinacetats farmakokinetiske profil påvirkes ikke hos ældre patienter med kreatininclearance >60 ml/min (se pkt.
English: Adverse reactions were usually mild to moderate in intensity and occurred predominantly during the first weeks of treatment with eslicarbazepine acetate.
Danish: Bivirkningernes styrke var sædvanligvis let til moderat, og de forekom hovedsagelig i løbet af de første ugers behandling med eslicarbazepinacetat.
English: Thus, interactions can arise when coadministering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19.
Danish: Der kan derfor opstå interaktion ved samtidig administration af høje doser eslicarbazepinacetat og lægemidler, der hovedsageligt metaboliseres af CYP2C19.
English: • Eye movement changes, fuzzy vision, red eye or eye pain
Danish: • Forandrede øjenbevægelser, sløret syn, røde øjne eller øjensmerter
English: • you are allergic (hypersensitive) to the active substance (eslicarbazepine acetate), to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients
Danish: • hvis De er overfølsom (allergisk) over for eslicarbazepinacetat, andre carboxamidderivater (f.eks. carbamazepin eller oxcarbazepin, som er medicin til behandling af epilepsi) eller et af de øvrige indholdsstoffer
English: It is unknown whether eslicarbazepine acetate is excreted in human breast milk.
Danish: Det vides ikke, om eslicarbazepinacetat udskilles i human modermælk.
English: If signs or symptoms of hypersensitivity develop, Exalief must be discontinued.
Danish: Hvis der opstår symptomer på overfølsomhed, skal Exalief seponeres.
English: • The active substance is eslicarbazepine acetate.
Danish: • Aktivt stof: Eslicarbazepinacetat.
English: Caution should be exercised in patients with medical conditions (e.g. low levels of thyroxine, cardiac conduction abnormalities), or when taking concomitant medicinal products known to be associated with PR prolongation.
Danish: Der bør udvises forsigtighed hos patienter med medicinske tilstande (fx lavt thyroxinniveau, kardiale ledningsforstyrrelser), eller ved samtidig brug af lægemidler, der normalt forbindes med PRforlængelse.
English: Exalief may be taken with or without food.
Danish: Exalief kan tages alene eller i forbindelse med et måltid.
English: The use of eslicarbazepine acetate is associated with increase in the PR interval.
Danish: Brug af eslicarbazepinacetat er sat i forbindelse med et forlænget PR-interval.
English: Symptoms include tremors, pain, cramping.
Danish: Symptomerne omfatter skælven, smerter og kramper
English: • Reduction in white blood cells which makes infections more likely
Danish: • Nedsat antal hvide blodlegemer og dermed øget risiko for infektion
English: As the efficacy of this supplementation is not proven, a specific antenatal diagnosis can be offered even for women with a supplementary treatment of folic acid.
Danish: Effekten af dette tilskud er ikke dokumenteret, og gravide kvinder kan derfor få tilbudt en særlig antenatal udredning, også selv om de får tilskud af folinsyre.
English: • Difficulty in concentration
Danish: • Nedsat koncentration
English: Rare side effects are:
Danish: Sjældne bivirkninger:
English: Exalief may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment.
Danish: Exalief kan give svimmelhed og sløvhed og påvirke synet, særligt i begyndelsen af behandlingen.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Danish: Hvis De vil have yderligere oplysninger om Exalief, skal De henvende Dem til indehaveren af markedsføringstilladelsen.
English: • you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval.
Danish: • hvis De tager medicin, der kan give forstyrrelser i hjertediagrammet (EKG) i form af et øget PR-interval.
English: • Sweating or having dry skin
Danish: • Svedtendens eller tør hud
English: • Swelling in your legs and arms
Danish: • Hævelser i arme og ben
English: • Tell your doctor if you are taking carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the following side effects of Exalief may occur in higher frequency: seeing double, abnormal coordination and dizziness.
Danish: • Fortæl det til lægen, hvis De tager carbamazepin (medicin mod epilepsi), da dosis måske skal justeres, og da hyppigheden af visse bivirkninger ved Exalief (dobbeltsyn, koordinationsbesvær og svimmelhed) kan øges.
English: Caution should be exercised in the treatment of patients with renal impairment and the dose should be adjusted according to creatinine clearance (see section 4.2).
Danish: Der bør udvises forsigtighed ved behandling af patienter med nedsat nyrefunktion, og dosis skal justeres i henhold til kreatininclearance (se pkt.
English: Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighed er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Co-administration of eslicarbazepine acetate 1,200 mg once daily with warfarin showed a small (23%) but statistically significant decrease in exposure to S-warfarin.
Danish: Samtidig administration af eslicarbazepinacetat 1200 mg en gang dagligt og warfarin viste et lille (23 %), men statistisk signifikant fald i eksponeringen for S-warfarin.
English: The frequency of possible side effects listed below is defined as using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000)
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter): Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 patienter) Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 patienter) Sjældne bivirkninger (forekommer hos mellem 1 og 10 ud af 10.000 patienter) Meget sjældne bivirkninger (forekommer hos færre end 1 ud af 10.000 patienter)
English: In vitro eslicarbazepine is a weak inducer of CYP3A4 and UDP-glucuronyl transferases.
Danish: I in vitro-undersøgelser har eslicarbazepin vist sig som en svag induktor af CYP3A4 og UDP-glukuronyltransferaser.
English: The use of Exalief is associated with an abnormality in ECG (electrocardiogram) called increase in PR interval.
Danish: Brug af Exalief sættes i forbindelse med en uregelmæssighed på hjertediagrammet (EKG'et), der kaldes forlænget PR-interval.
English: • Worsening of seizures
Danish: • Forværring af anfald
English: • Ear pain or ringing in the ears
Danish: • Ørepine eller ringen for ørerne
English: - CLCR <30 ml/min: use is not recommended in patients with severe renal impairment due to insufficient data
Danish: - CLCR <30 ml/min: Brug af Exalief til patienter med alvorligt nedsat nyrefunktion frarådes pga.
English: Fatigue, gait disturbance
Danish: Træthed, gangforstyrre lser
English: Based on individual response, the dose of Exalief may need to be increased if used concomitantly with carbamazepine.
Danish: Afhængigt af den enkelte patients respons skal dosis af Exalief muligvis øges, hvis det anvendes sammen med carbamazepin.
English: • Reduction in blood platelets which increases risk of bleeding or bruising
Danish: • Nedsat antal blodplader og dermed øget risiko for blødninger og blå mærker
English: The precise mechanisms of action of eslicarbazepine acetate are unknown.
Danish: Eslicarbazepinacetats nøjagtige virkningsmekanisme kendes ikke.
English: HPDE bottles carton and HPDE bottles of 90 tablets
Danish: Æske med HDPE-flasker og HDPE-flasker med 90 tabletter
English: BIAL - Portela & Cª , S.A. À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Danish: Indehaver af markedsføringstilladelsen og fremstiller BIAL - Portela & Cª, S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
English: • When new information is received that may impact on the current Safety Specification,
Danish: • når der modtages ny information, der kan have indflydelse på den pågældende sikkerhedsspecifikation, pharmacovigilance-plan eller på risikominimeringsaktiviteter
English: Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.
Danish: Der kan opstå bivirkninger i forbindelse med denne uregelmæssighed (f.eks. besvimelse og langsommere puls).
English: In studies with eslicarbazepine in fresh human hepatocytes a mild activation of UGT1A1 mediated glucuronidation was observed.
Danish: I studier med eslicarbazepin i friske humane hepatocytter observeredes en svag glukuronidering, som skyldtes UGT1A1.
English: Increased appetite, decreased appetite, hyponatraemia, electrolyte imbalance, cachexia, dehydration, obesity
Danish: Øget appetit, nedsat appetit, hyponatriæmi, forstyrrelser i elektrolytbalancen, kakeksi, dehydrering, adipøsitet
English: In humans, the pharmacological activity of eslicarbazepine acetate is primarily exerted through the active metabolite eslicarbazepine.
Danish: Hos mennesker udøves eslicarbazepinacetats farmakologiske aktivitet primært gennem den aktive metabolit eslicarbazepin.
English: Moderate hepatic impairment did not affect the pharmacokinetics of eslicarbazepine acetate.
Danish: Moderat nedsat leverfunktion påvirkede ikke eslicarbazepinacetats farmakokinetik.
English: • Increased levels of circulating fats in your blood
Danish: • Forhøjet indhold af fedt (triglycerider) i blodet
English: Exalief must be added to existing anticonvulsant therapy.
Danish: Exalief gives som tillægsbehandling til eksisterende behandling.
English: The pharmacokinetics and metabolism of eslicarbazepine acetate were evaluated in healthy subjects and moderately liver-impaired patients after multiple oral doses.
Danish: Eslicarbazepinacetats farmakokinetik og metabolisme blev undersøgt hos raske forsøgspersoner og patienter med moderat nedsat leverfunktion efter gentagne orale doser.
English: The tablets are packaged in blisters in cardboard boxes containing 7, 14 or 28 tablets.
Danish: Tabletterne er pakket i blisterkort i æsker med 7, 14 eller 28 tabletter.
English: In patients with CLCR <30 ml/min use is not recommended due to insufficient data.
Danish: Exalief bør ikke anvendes til patienter med CLCR <30 ml/min pga. manglende dokumentation.
English: The risk of increase of other specific adverse reactions caused by co-administration of carbamazepine and eslicarbazepine acetate cannot be excluded.
Danish: Det kan ikke udelukkes, at der er risiko for en øget forekomst af andre specifikke bivirkninger ved samtidig administration af carbamazepin og eslicarbazepinacetat.
English: Eslicarbazepine acetate metabolites can effectively be cleared by haemodialysis, if necessary (see section 5.2).
Danish: Eslicarbazepinacetats metabolitter kan om nødvendigt fjernes effektivt med hæmodialyse (se pkt.
English: Blood pressure decreased, weight decreased, blood pressure diastolic decreased, blood pressure increased, blood pressure systolic decreased, blood sodium decreased, haematocrit decreased, haemoglobin decreased, heart rate increased, transaminases increased, triglycerides increased, triiodothyronine (T3) free decreased, thyroxine (T4) free decreased
Danish: Blodtryksfald, vægttab, fald i diastolisk blodtryk, forhøjet blodtryk, fald i systolisk blodtryk, fald i serumnatrium, fald i hæmatokritværdier, fald i hæmoglobinværdier, øget hjertefrekvens, forhøjede aminotransferaser, forhøjede triglycerider, fald i frit triiodthyronin (T3), fald i frit thyroxin (T4)
English: Eslicarbazepine acetate is rapidly and extensively biotransformed to its major active metabolite eslicarbazepine by hydrolytic first-pass metabolism.
Danish: Eslicarbazepinacetat omdannes hurtigt og i omfattende grad til den aktive hovedmetabolit eslicarbazepin ved hydrolytisk første-passagemetabolisme.
English: The presence of HLA-B*1502 allele in other ethnicities is negligible.
Danish: Hos andre etniske grupper forekommer HLA-B*1502 kun yderst sjældent.
English: Glucuronidation is the major metabolic pathway for both eslicarbazepine and lamotrigine and therefore an interaction could be expected.
Danish: Metabolismen for både eslicarbazepin og lamotrigin finder især sted ved glukuronidering, hvorfor interaktion kunne forventes.
English: Exalief has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury.
Danish: Exalief er sat i forbindelse med visse bivirkninger i centralnervesystemet, fx svimmelhed og døsighed, som kan øge forekomsten af tilskadekomst.
English: The pharmacokinetics of eslicarbazepine has not been evaluated in patients with severe hepatic impairment.
Danish: Eslicarbazepins farmakokinetik er ikke undersøgt hos patienter med alvorligt nedsat leverfunktion.
English: Exalief 400 mg tablets are white, circular and biconvex.
Danish: Exalief 400 mg tabletter er hvide, runde og bikonvekse.
English: No cases of serious cutaneous reactions have been reported with eslicarbazepine acetate.
Danish: Der er ikke indberettet tilfælde af alvorlige hudreaktioner i forbindelse med eslicarbazepinacetat.
English: • Tell your doctor if you are taking the blood thinner - warfarin.
Danish: • Fortæl det til lægen, hvis De tager den blodfortyndende medicin warfarin.
English: Do not breast-feed while you are taking Exalief.
Danish: De må ikke amme, mens De tager Exalief.