FrancophonIA/ELRC3.0 huggingface dataset:
English: Study 208 included 2 additional subsequent long-term, open-label extensions (1 year in part II and 2 years in part III) and Study 305 included 4 subsequent long-term, open-label extension periods (1 year in Parts II, III and IV and 2 years in Part V).
Danish: Studie 208 omfattede yderligere 2 efterfølgende åbne forlængelsesstudier (1 år i del II og 2 år i del III), og studie 305 omfattede 4 efterfølgende åbne forlængelsesstudier (1 år i del II, III og IV og 2 år i del V).
English: • if 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: Hyponatraemia, decreased appetite
Danish: Hyponatriæmi, nedsat appetit
English: • Blood tests showing that you have low levels of salts (including chloride) in your blood or a reduction in red blood cells;
Danish: • blodprøver, der viser et lavt indhold af salte (inklusive chlorid) eller et fald i de røde blodlegemer
English: Please tell your doctor:
Danish: Fortæl det til lægen:
English: Second or third degree atrioventricular (AV) block.
Danish: Anden eller 3. grads atrioventrikulært blok (AV-blok).
English: During the reporting period, the MAH detected a signal of overdose.
Danish: I rapporteringsperioden detekterede markedsføringstilladelsesindehaveren et signal for overdosis.
English: HLA-A*3101 allele has a prevalence of 2 to 5% in European populations and about 10% in Japanese population.
Danish: HLA-A*3101-allelen har en prævalens på 2 til 5 % i den europæiske befolkning og på omkring 10 % i den japanske befolkning.
English: • if 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: • Attention deficit/ hyperactivity disorder;
Danish: • nedsat opmærksomhed/hyperaktivitet
English: Both studies were double-blind and placebo controlled with a duration of maintenance of 8 weeks (study 208) and 12 weeks (study 305), respectively.
Danish: Begge studier var dobbeltblinde og placebokontrollerede med en varighed på henholdsvis 8 uger (studie 208) og 12 uger (studie 305).
English: • Slower or irregular heart beat;
Danish: • langsommere eller uregelmæssig puls
English: Taking into consideration the limitations of open label uncontrolled data, the long-term response to eslicarbazepine acetate in the open-label parts of the study was overall maintained.
Danish: I betragtning af begrænsningerne ved åbne ukontrollerede data blev langtidsrespons over for eslicarbazepinacetat opretholdt i de åbne dele af studiet.
English: The target dose was 30 mg/kg/day in study 208 and 20 mg/kg/day in study 305.
Danish: Måldosis var 30 mg/kg/dag i studie 208 og 20 mg/kg/dag i studie 305.
English: This time delay must be taken into account when Zebinix is being used just prior to or in combination with other medicinal products that require dose adjustment when co-administered with Zebinix.
Danish: Der skal tages højde for denne forhaling, når Zebinix anvendes umiddelbart før eller i kombination med andre lægemidler, der kræver dosisjustering, når de gives sammen med Zebinix.
English: The data shows that the incidence of adverse reactions in this population (65.3 %) is similar to the general population enrolled in the double-blind epilepsy studies (66.8%).
Danish: Dataene viser, at forekomsten af bivirkninger i denne population (65,3 %) svarer til forekomsten i den generelle population, som er inkluderet i de dobbeltblinde epilepsistudier (66,8 %).
English: A small number of people being treated with antiepileptics 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: Research has shown an increased risk of birth defects in children of women taking antiepileptic medicines.
Danish: Undersøgelser har vist, at der er en øget risiko for misdannelser hos børn af kvinder, der tager medicin mod epilepsi.
English: NN: (only for outer packaging)
Danish: NN: (kun på den ydre emballage)
English: The steady state plasma concentrations are attained after 4 to 5 days of once daily dosing, consistent with an effective half-life in the order of 20-24 hours.
Danish: Steady state-plasmakoncentration opnås efter 4 til 5 dages daglig indgift, svarende til en effektiv halveringstid på 20 til 24 timer.
English: Therefore, patients should be advised that their physical and/or mental abilities needed for operating machinery or driving may be impaired and they are recommended not to do so until it has been established that their ability to perform such activities is not affected.
Danish: Patienterne skal derfor orienteres om, at deres fysiske og/eller mentale evne til at betjene maskiner eller færdes i trafikken kan være svækket, og at det bør undgås, indtil det er fastslået, at deres evne til at udføre disse aktiviteter ikke er påvirket.
English: To ease the process you should mark the desired volume in the syringe by moving the plunger.
Danish: For at gøre processen lettere kan det ønskede volumen markeres i sprøjten ved at flytte stemplet.
English: There are insufficient data supporting a recommendation for HLA-A*3101 screening before starting carbamazepine or chemically-related compounds treatment.
Danish: Der er utilstrækkelige data til at understøtte en anbefaling af HLA-A*3101-screening før behandling med carbamazepin eller kemisk beslægtede lægemidler.
English: Swallow the tablet with a glass of water.
Danish: Tabletterne sluges hele med et glas vand.
English: If you have kidney problems you will usually be given a lower dose of Zebinix.
Danish: Hvis De har nyreproblemer, vil De sædvanligvis få en lavere dosis af Zebinix.
English: • Ringing in the ears;
Danish: • ringen for ørerne
English: If you forget to take a dose, take it as soon as you remember and carry on as usual.
Danish: Hvis De har glemt at tage en dosis, skal De tage den, så snart De kommer i tanke om det og derefter fortsætte som vanligt.
English: Press the plugger down slowly to release Zebinix into the mouth.
Danish: Tryk langsomt stemplet ned, så Zebinix sprøjtes ind i munden.
English: If you develop a serious rash or another skin symptoms (see section 4), stop taking Zebinix and contact your doctor or seek medical attention immediately.
Danish: Hvis De udvikler et alvorligt udslæt eller andre hudsymptomer (se pkt 4), skal De stoppe med at tage Zebinix og kontakte Deres læge eller søge akut lægehjælp.
English: Urticaria and angioedema cases have been reported in patients taking Zebinix.
Danish: Tilfælde af urticaria og angioødem er blevet rapporteret hos patienter, der tager Zebinix.
English: If Zebinix is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency.
Danish: Hvis Zebinix skal seponeres, anbefales det at gøre det gradvist for at mindske risikoen for øget anfaldshyppighed.
English: Switching preparations
Danish: Skift mellem præparater
English: When initiating or discontinuing treatment with Zebinix or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity.
Danish: Ved indledning eller seponering af behandling med Zebinix eller ændring af dosis kan det tage 2-3 uger atter at opnå enzymaktivitet.
English: Since the relationship between exposure and drug activity is unclear, the monitoring of response to therapy (e.g., cholesterol levels) is recommended.
Danish: Da forholdet mellem eksponering og lægemiddelaktivitet er uklart, anbefales det at monitorere behandlingsresponset (fx kolesteroltal).
English: Place the oral syringe into the mouth against the inside of the cheek.
Danish: Anbring mundsprøjten i munden mod indersiden af kinden.
English: Zebinix belongs to a group of medicines called antiepileptics used to treat epilepsy, a condition where someone has repeated seizures or fits.
Danish: Zebinix hører til en gruppe medicin, der kaldes antiepileptika, som anvendes til behandling af epilepsi, en tilstand med gentagne anfald eller kramper.
English: Ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet.
English: Multipack: 180 (2 packs of 90) tablets
Danish: Multipakning: 180 (2 pakninger a 90) tabletter.
English: A study in adult patients with mild to severe renal impairment showed that clearance is dependent on renal function.
Danish: Et studie med voksne patienter med let til svært nedsat nyrefunktion viste, at clearance afhænger af nyrefunktionen.
English: Zebinix has minor to moderate influence on the ability to drive and use machines.
Danish: Zebinix påvirker i mindre til moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Step 6: If you see any air bubbles in the oral syringe, push the plunger upwards just far enough to completely push out any large air bubbles.
Danish: Trin 6: Hvis der observeres luftbobler i mundsprøjten, skal stemplet presses opad så langt, at store luftbobler presses ud.
English: Your doctor will work out the correct dose for you.
Danish: Deres læge vil finde ud af hvilken dosis, der er den korrekte til Dem.
English: Considering that changes in body weight can influence the treatment decision and are of particular importance in epilepsy which itself may be associated with overweight/obesity this information should adequately be reflected in SmPC and PIL.
Danish: Eftersom ændringer i kropsvægt kan påvirke behandlingsbeslutningen og er særlig vigtig ved epilepsi, som i sig selv kan være forbundet med overvægt/fedme, bør denne oplysning afspejles i tilstrækkelig grad i produktresume (SmPC) og indlægsseddel (PIL).
English: Gently pull the plunger back downwards to the dose prescribed by your doctor.
Danish: Træk forsigtigt stempel tilbage nedad til den dosis, som lægen har ordineret.
English: Your doctor should be able to advise if a blood test is necessary before taking Zebinix.
Danish: Deres læge vil rådgive Dem om, hvorvidt en blodprøve er nødvendig, før De tager Zebinix.
English: Your doctor will decide how long you should take Zebinix.
Danish: Deres læge afgør, hvor længe De skal tage Zebinix.
English: The mechanism by which bone metabolism is affected has not been identified.
Danish: Den mekanisme, der påvirker knoglemetabolismen, er ikke identificeret.
English: The chemical structure of eslicarbazepine acetate is similar to that of carbamazepine, and it is possible that patients who are positive for HLA-B*1502 may also be at risk for SJS after treatment with eslicarbazepine acetate.
Danish: Den kemiske struktur af eslicarbazepinacetat ligner carbamazepins, og det er muligt, at patienter, der er positive for HLA-B*1502, også kan være i risiko for at udvikle SJS efter behandling med eslicarbazepinacetat.
English: Interactions with other antiepileptic medicinal products
Danish: Interaktion med andre antiepileptika
English: There was no effect on the Rwarfarin pharmacokinetics or on coagulation.
Danish: Der sås ingen virkning på Rwarfarins farmakokinetik eller på koagulationen.
English: Only a few subjects (N=27) aged above 65 years were treated with eslicarbazepine acetate in monotherapy study.
Danish: Kun få forsøgspersoner (N=27) over 65 år blev behandlet med eslicarbazepinacetat i monoterapistudiet.
English: If women receiving eslicarbazepine acetate become pregnant or plan to become pregnant, the use of Zebinix should be carefully re-evaluated.
Danish: Hvis en kvinde i behandling med eslicarbazepinacetat bliver gravid eller planlægger graviditet, skal brug af Zebinix atter overvejes grundigt.
English: • Skin changes (e.g. red skin);
Danish: • forandringer i hud (f.eks. rød hud)
English: • Burning sensation;
Danish: • brændende fornemmelse
English: All subjects were randomized to the lowest dose level and only if a seizure occurred subjects were to be escalated to the next dose level.
Danish: Alle forsøgspersoner blev randomiseret til laveste dosisniveau, og dosis blev kun øget til næste dosisniveau, hvis forsøgspersonen fik et anfald.
English: • do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, 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 Zebinix, da det er uvist, om det er sikkert at tage de to lægemidler samtidig.
English: • Weight increase.
Danish: • vægtstigning.
English: • Poor memory or forgetfulness;
Danish: • dårlig hukommelse eller glemsomhed
English: Taking into account the PRAC Assessment Report on the PSUR(s) for eslicarbazepine acetate, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for eslicarbazepinacetat er CHMP nået frem til følgende videnskabelige konklusioner:
English: Furthermore, serum sodium levels should be determined if clinical signs of hyponatraemia occur.
Danish: Endvidere bør serumnatrium måles, hvis der opstår kliniske tegn på hyponatriæmi.
English: Zebinix is not to be given to children aged 6 years and below.
Danish: Zebinix må ikke gives til børn på 6 år og derunder.
English: • if you suffer from a heart disease such as heart failure or heart attack, or have any heart rhytm disorder.
Danish: • hvis De har dårligt hjerte, f.eks. hjertesvigt eller hjerteanfald eller har nogen form for hjerterytmeforstyrrelse.
English: The safety profile of eslicarbazepine acetate was generally similar between adult and paediatric patients, except for agitation (common, 1.3%) and abdominal pain (common, 2.1%) which were more common in children than in adults.
Danish: Sikkerhedsprofilen for eslicarbazepinacetat var generelt ens mellem voksne og pædiatriske patienter, bortset fra agitation (almindelig, 1,3 %) og abdominalsmerter (almindelig, 2,1 %), der var mere almindelig hos børn end hos voksne.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications.
Danish: Der er indberettet selvmordstanker og -adfærd hos patienter i behandling med antiepileptika på en række forskellige indikationer.
English: Eye and nervous system disorders
Danish: Øjne og nervesystemet
English: Other form of this medicine, like oral suspension, maybe more suitable for children.
Danish: En anden form af dette lægemiddel, en opløsning til indtagelse gennem munden, er muligvis mere egnet til børn.
English: Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe vises bivirkningerne med faldende alvorlighed.
English: Be careful, do not push the plunger down when removing the oral syringe from the bottle.
Danish: Vær forsigtig med ikke at presse stemplet ned, når du fjerner mundsprøjten fra flasken.
English: Zebinix is indicated as:
Danish: Zebinix er indiceret som:
English: Eslicarbazepine Cmax is attained at 2 to 3 hours post-dose (tmax).
Danish: Eslicarbazepin Cmax opnås 2 til 3 timer efter administration (tmax).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zebinix in one or more subsets of the paediatric population in the treatment of epilepsy with partial onset seizures (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Zebinix i en eller flere undergrupper af den pædiatriske population til behandling af epilepsi med partielle anfald (se pkt.
English: In addition, there are six post-marketing cases of ‘weight increase' for which the causality was assessed as possibly related to eslicarbazepine acetate by the MAH.
Danish: Derudover foreligger seks postmarketing tilfælde af ‘vægtstigning', hvor markedsføringstilladelsesindehaveren vurderede kausaliteten som muligvis relateret til eslicarbazepinacetat.
English: Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing eslicarbazepine acetate were warranted.
Danish: I betragtning af de fremlagte data i den gennemgåede PSUR vurderede PRAC derfor, at det er påkrævet at indføre ændringer i produktinformationen for lægemidler, der indeholder eslicarbazepinacetat.
English: Talk to your doctor or pharmacist before taking Zebinix.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Zebinix.
English: Very common (may affect more than 1 in 10 people) side effects are: • Feeling dizzy or sleepy.
Danish: Meget almindelige bivirkninger (forekommer hos mere end 1 ud af 10 personer): • svimmelhed eller søvnighed
English: In studies in healthy subjects and epileptic adult patients, the apparent half-life of eslicarbazepine was 10-20 hours and 13-20 hours, respectively.
Danish: I studier med raske forsøgspersoner og voksne epilepsipatienter sås en halveringstid for eslicarbazepin på henholdsvis 10-20 timer og 13-20 timer.
English: The presence of HLA-A*3101 allele may increase the risk for carbamazepine induced cutaneous reactions (mostly less severe) from 5.0% in general population to 26.0% among subjects of European ancestry, whereas its absence may reduce the risk from 5.0% to 3.8%.
Danish: Tilstedeværelse af HLA-A*3101-allelen kan øge risikoen for carbamazepin-inducerede hudreaktioner (for det meste mindre alvorlige) fra 5 % i den samlede befolkning til 26 % blandt personer af europæisk oprindelse, hvorimod dens fravær reducerer risikoen fra 5 % til 3,8 %.
English: Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia, abnormal coordination and dizziness.
Danish: Resultater fra studier med patienter viste, at samtidig behandling øger risikoen for følgende bivirkninger: Diplopi, koordinationsbesvær og svimmelhed.
English: The bottle can be closed with the closure with the bottle adapter still in place.
Danish: Flasken kan lukkes med låget, selvom flaskeadapteren stadig sidder i.
English: • Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or lower legs;
Danish: • alvorlig allergisk reaktion, der forårsager hævelse af ansigt, hals, hånd, fødder, ankler eller underben
English: In patients of Han Chinese or Thai origin the risk of serious skin reactions associated with carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these patients.
Danish: Hos patienter af hankinesisk eller thailandsk oprindelse kan risikoen for alvorlige hudreaktioner i forbindelse med carbamazepin eller kemisk beslægtede lægemidler forudsiges ved at tage en blodprøve fra disse patienter.
English: 14 patients (9.2%) completed open-label treatment with ESL through Part V. The most common reason for withdrawal during any part of the study was sponsor request (30 patients in part III [19.7% of the patients who entered part III], 9 in part IV [9.6% of the patients who entered part IV], and 43 in part V [64.2% of the patients who entered Part V]).
Danish: 14 patienter (9,2 %) fuldførte åben behandling med ESL i del V. Den hyppigste årsag til seponering i alle dele af studiet skete efter anmodning af sponsor (30 patienter i del III [19,7 % af patienterne, som deltog i del III], 9 i del IV [9,6 % af patienterne, som deltog i del IV] og 43 i del V [64,2 % af patienterne, som deltog i del V]).
English: The overall median relative decrease in Part I was greater in patients treated with ESL (-25.8%) than in patients treated with placebo (-16.4%).
Danish: Den samlede mediane relative reduktion i del I var større hos patienter, der blev behandlet med ESL (-25,8 %) end hos patienter, der blev behandlet med placebo (-16,4 %).
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic 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: • Increased bone proteins;
Danish: • øget niveau af knogleproteiner
English: Should your doctor decide to stop your treatment with Zebinix your dose will usually be reduced gradually.
Danish: Hvis lægen beslutter at stoppe behandlingen med Zebinix, skal doseringen sædvanligvis nedtrappes.
English: If you accidently take more Zebinix than you should, you are potentially at risk of having more seizures; or you may feel like your heart beat is irregular or faster.
Danish: Hvis De er kommet til at tage for meget Zebinix, har De muligvis risiko for at få flere anfald; eller det kan føles som om Deres hjerterytme er uregelmæssig eller hurtige.
English: In the subsequent 1-year open-label extension (Part II) of the phase III study (ITT set N=225) the total responder rate was 46.7% (steadily increasing from 44.9% (weeks 1-4) to 57.5% (weeks > 40)).
Danish: I det efterfølgende åbne forlængelsesstudie af 1 års varighed (del II) i fase III-studiet (ITT set N=225) var den totale responsrate 46,7 % (støt stigende fra 44,9 % (uge 1-4) til 57,5 % (uge > 40)).
English: Based on this outcome, update of section 4.8 of the SmPC to add ‘weight increased' with the frequency common (calculation based on clinical trial data) is recommended.
Danish: 4.8 i SmPC'et, så “vægtstigning” tilføjes med hyppigheden almindelig (beregning baseret på data fra kliniske studier).
English: Population pharmacokinetics indicate that in the subgroup of children aged from 2 to 6 years, doses of 27.5 mg/kg/day and 40 mg/kg/day are required in order to achieve exposures that are equivalent to the therapeutic doses of 20 and 30 mg/kg/day in children above 6 years of age.
Danish: Populationsfarmakokinetikken viser, at det i undergruppen med børn i alderen fra 2 til 6 år er nødvendigt med doser på 27,5 mg/kg/dag og 40 mg/kg/dag for at opnå eksponeringer, der svarer til de terapeutiske doser på 20 og 30 mg/kg/dag hos børn over 6 år.
English: (only for outer packaging)
Danish: (kun på den ydre emballage)
English: If patients of European descent or Japanese origin are known to be positive for HLA-A*3101 allele, the use of carbamazepine or chemically-related compounds may be considered if the benefits are thought to exceed risks.
Danish: Hvis patienter af europæisk eller japansk oprindelse vides at være positive for HLA-A*3101-allellen, bør anvendelse af carbamazepin eller kemisk beslægtede lægemidler kun overvejes, hvis fordelene forventes at overstige risikoen.
English: Zebinix 50 mg/ml is an off-white to white oral suspension.
Danish: Zebinix 50 mg/ml er en off-white til hvid oral suspension.
English: Angioedema in the context of hypersensitivity/anaphylactic reaction associated with laryngeal oedema can be fatal.
Danish: Angioødem i forbindelse med overfølsomhed/anafylaktisk reaktion forbundet med laryngeal ødem kan være letalt.
English: Ossification delays, reduced foetal weights, an increase in minor skeletal and visceral anomalies were observed at maternal toxic doses in embryotoxicity studies in mice, rats and rabbits.
Danish: Forsinkede ossifikationer, reducerede fostervægte, en stigning i mindre knogle- og viscera-anomalier blev observeredet ved maternale toksiske doser i embryotoksicitetsstudier med mus, rotter og kaniner.
English: In the subsequent 3 open-label extensions (ITT set N=148), the overall responder rate was 26.6% when compared to baseline Parts III-V (i.e. the last 4 weeks in part II).
Danish: I de efterfølgende 3 åbne forlængelsesstudier (ITT set N=148) var den samlede responsrate 26,6 % sammenlignet med del III-V ved baseline (dvs. de sidste 4 uger af del II).
English: 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: 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: Zebinix may be taken as monotherapy or added to existing anticonvulsant therapy.
Danish: Zebinix kan tages som monoterapi eller gives som tillægsbehandling til eksisterende antiepileptisk behandling.