FrancophonIA/ELRC3.0 huggingface dataset:
English: HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations
Danish: HLA-B*1502-allel - personer af hankinesisk, thailandsk og anden asiatisk oprindelse
English: Seizure-free rates during the entire 10-week monotherapy period were 7.6% (1,600 mg) and 8.3 % (1,200 mg) in one study and 10.0% (1,600 mg) and 7.4 % (1,200 mg) in the other study, respectively.
Danish: Frekvensen for anfaldsfrihed i den 10 uger lange periode med monoterapi var henholdsvis 7,6 % (1.600 mg) og 8,3 % (1.200 mg) i det ene studie og 10,0 % (1.600 mg) og 7,4 % (1.200 mg) i det andet studie.
English: Not known (frequency cannot be estimated from available data) side effects are:
Danish: Ikke kendte bivirkninger (hyppigheden kan ikke vurderesud fra tilgængelige data):
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Patienten skal derfor monitoreres for tegn på selvmordstanker og -adfærd, og passende behandling bør overvejes.
English: Contact a doctor or go to a hospital immediately if you experience any of the above symptoms.
Danish: Kontakt straks en læge, eller tag på skadestuen med det samme, hvis De får et eller flere af ovennævnte symptomer.
English: If patients of these ethnic origins are tested positive for HLA- B*1502 allele, the use of eslicarbazepine acetate may be considered if the benefits are thought to exceed risks.
Danish: Hvis patienter af disse etniske oprindelser testes positive for HLA-B*1502-allelen, bør anvendelse af eslicarbazepinacetat kun overvejes, hvis fordelene forventes at opveje risikoen.
English: • Swelling in your legs and arms;
Danish: • hævelser i arme og ben
English: • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
Danish: • monoterapi til behandling af fokale epileptiske anfald med eller uden sekundær generalisering hos voksne med nyligt diagnosticeret epilepsi;
English: Adverse reactions 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: • Low blood pressure or a fall in blood pressure on standing up;
Danish: • lavt blodtryk eller blodtryksfald, når man rejser sig
English: Step 5: Hold the oral syringe in place and turn the bottle upside down.
Danish: Trin 5: Hold mundsprøjten på plads, og vend flasken om med bunden i vejret.
English: The following convention has been used for the classification of adverse reactions 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: Der er benyttet følgende konvention til klassificering af bivirkningerne: meget almindelige ≥1/10, almindelige ≥1/100 til <1/10, ikke almindelige ≥1/1.000 til <1/100 og ikke kendte (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Danish: Delekærven er kun beregnet til, at De kan dele tabletten, hvis De har svært ved at sluge den hel.
English: • Severe pain in the back and stomach (caused by inflamation of the pancreas);
Danish: • voldsomme ryg- og mavesmerter (på grund af betændelse i bugspytkirtlen)
English: Based on this outcome, update of section 4.9 to reflect new information from overdose cases is recommended.
Danish: 4.9, så det afspejler den nye information fra tilfælde af overdosis.
English: Eslicarbazepine acetate 800 mg once daily and 1,200 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 1.200 mg en gang dagligt var signifikant mere effektive end placebo til at nedsætte hyppigheden af anfald over en 12-ugers vedligeholdelsesperiode.
English: • if you have liver problems.
Danish: • hvis De har dårlig lever.
English: • Eye movement changes, fuzzy vision or red eye;
Danish: • forandrede øjenbevægelser, sløret syn eller røde øjne
English: The recommended starting dose is 10 mg/kg/day once daily.
Danish: Den anbefalede initialdosis er 10 mg/kg/dag én gang dagligt.
English: (≥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: almindelige ≥1/100 til <1/10, ikke almindelige ≥1/1.000 til <1/100 og ikke kendte (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: HLA-B* 1502 in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing the severe cutaneous reactions known as Stevens Johnson syndrome (SJS) when treated with carbamazepine.
Danish: Forekomst af HLA-B*1502 hos personer af hankinesisk eller thailandsk oprindelse er vist at være stærkt forbundet med risikoen for at udvikle de alvorlige hudreaktioner, der er kendt som StevensJohnsons syndrom (SJS), når disse personer behandles med carbamazepin.
English: 400 mg once daily for one or two weeks, before increasing to the maintenance dose.
Danish: 400 mg en gang dagligt i en eller to uger, inden der øges til vedligeholdelsesdosen.
English: • Tingling and/or feeling numb in any part of your body;
Danish: • snurrende fornemmelse og/eller følelsesløshed et eller flere steder i kroppen
English: Concomitant use of eslicarbazepine acetate with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites.
Danish: Eslicarbazepinacetat anbefales ikke sammen med oxcarbazepin, da dette kan forårsage overeksponering for de aktive metabolitter.
English: Electrolyte imbalance, dehydration, hypochloraemia
Danish: Forstyrrelser i elektrolytbalancen, dehydrering, hypokloræmi
English: No dose adjustment is needed in the elderly population provided that the renal function is not disturbed.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter, så længe nyrefunktionen ikke er påvirket.
English: • High blood pressure or severe increase in blood pressure;
Danish: • højt blodtryk eller stort blodtryksfald
English: This will create pressure inside the bottle that will help the dosing of the suspension, forcing it to leave from the bottle to the oral syringe.
Danish: Dette vil frembringe et tryk inde i flasken, som vil være en hjælp ved doseringen af opløsningen, idet den presses ud af flasken ind i mundsprøjten.
English: Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment, have a history of osteoporosis, or take steroids.
Danish: Tal med lægen eller apotekspersonalet, hvis De er i langvarig behandling med epilepsimedicin, lider af knogleskørhed eller tager steroider.
English: The total median standardised seizure frequency was 6.1 (decreasing from 7.0 (weeks 1-4) to 4.0 (weeks > 40), resulting in a median relative change compared to the baseline period of -46.7%).
Danish: Total median standardiseret anfaldsfrekvens var 6,1 (faldende fra 7,0 (uge 1-4) til 4,0 (uge > 40), hvilket resulterede i en median relativ forskel på -46,7 % i forhold til baseline-perioden).
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskompli kationer
English: Insert the bottle adapter in the bottle neck opening.
Danish: Sæt flaskeadapteren i åbningen på flaskehalsen.
English: The information currently provided in section 4.9 of the SmPC is limited and does not reflect a potential cardiac risk of eslicarbazepine acetate overdose or the risk of seizure induction.
Danish: 4.9 i SmPC'et er begrænset og afspejler ikke den potentielle kardielle risiko ved overdosis af eslicarbazepinacetat eller risikoen for at inducere anfald.
English: Eslicarbazepine acetate
Danish: Eslicarbazepinacetat
English: HLA-A*3101 allele- European descent and Japanese populations
Danish: HLA-A*3101-allel - personer af europæisk og japansk oprindelse
English: From the 815 randomized patients, 401 patients were treated with eslicarbazepine acetate once-daily [271 patients (67.6%) remained at dose of 800 mg, 70 patients (17.5%) remained at dose of 1,200 mg and 60 patients (15.0%) were treated with 1,600 mg].
Danish: Ud af de 815 randomiserede patienter blev 401 patienter behandlet med eslicarbazepinacetat en gang dagligt [271 patienter (67,6 %) forblev på en dosis på 800 mg, 70 patienter (17,5 %) forblev på en dosis på 1.200 mg, og 60 patienter (15,0 %) blev behandlet med 1.600 mg].
English: In the 10-month study decreases in bone mineral content, bone area and/or bone mineral density in lumbar vertebrae and/or femur were observed in high-dose female animals at exposure levels lower than the clinical exposure levels to eslicarbazepine in children.
Danish: I det 10 måneder lange studie observeredes fald i knoglemineralindhold, knogleareal og/eller knoglemineraldensitet i lumbale vertebrae og/eller femur hos højdosis-hundyr ved eksponeringsniveauer, der var lavere end de kliniske eksponeringsniveauer for eslicarbazepin hos børn.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Danish: Patienterne skal ved ordination informeres om tegnene og symptomerne og monitoreres nøje for hudreaktioner.
English: Caution should be exercised in the treatment of patients, adult and children above 6 years of age, with renal impairment and the dose should be adjusted according to creatinine clearance (CLCR) as follows: - CLCR >60 ml/min: no dose adjustment required.
Danish: Der skal udvises forsigtighed ved behandling af patienter, voksne og børn over 6 år, med nedsat nyrefunktion, og dosis skal justeres i henhold til kreatininclearance (CLCR) som følger: - CLCR >60 ml/min: Dosisjustering ikke nødvendig.
English: On the basis of the scientific conclusions for eslicarbazepine acetate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing eslicarbazepine acetate is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for eslicarbazepinacetat er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder eslicarbazepinacetat, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Store the bottle and the oral syringe together in the carton until next use.
Danish: Opbevar flasken og mundsprøjten sammen i æsken til næste anvendelse.
English: If signs or symptoms of hypersensitivity develop, eslicarbazepine acetate must be discontinued immediately and alternative treatment should be initiated.
Danish: Hvis der opstår symptomer på overfølsomhed, skal eslicarbazepinacetat straks seponeres, og alternativ behandling indledes.
English: • hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less effective;
Danish: • hormonal prævention (som for eksempel p-piller), da Zebinix kan nedsætte dens virkning.
English: There are no data on the effects of eslicarbazepine acetate on human fertility.
Danish: Der er ingen data om virkningen af eslicarbazepinacetat på human fertilitet.
English: In the analysis of treatment failure (seizure risk) based on time to event analysis (Kaplan-Meier analysis and Cox regression), the Kaplan-Meier estimates of seizure risk at the end of the evaluation period was 0.06 with carbamazepine and 0.12 with eslicarbazepine acetate and by the end of 1 year with an additional increased risk to 0.11 with carbamazepine and 0.19 with eslicarbazepine acetate (p=0.0002).
Danish: I analysen af behandlingssvigt (risiko for krampeanfald) baseret på tid-til-hændelse-analyse (Kaplan-Meier-analyse og Cox-regressionsanalyse) var Kaplan-Meier-estimatet af risiko for krampeanfald 0,06 med carbamazepin og 0,12 med eslicarbazepinacetat i slutningen af evalueringsperioden, og i slutningen af år 1 var risikoen steget til 0,11 med carbamazepin og 0,19 med eslicarbazepinacetat (p=0,0002).
English: • Decrease of appetite;
Danish: • nedsat appetit
English: Because of the prevalence of this allele in other Asian populations (e.g, above 15% in the Philippines and Malaysia), testing genetically at risk populations for the presence of HLA- B*1502 may be considered.
Danish: På grund af hyppigheden af HLA-B*1502-allelen i andre asiatiske befolkningsgrupper (fx over 15 % i Filippinerne og Malaysia) bør gen test for tilstedeværelsen af denne allel overvejes hos risiko populationer.
English: The efficacy and safety of eslicarbazepine acetate as adjunctive therapy for partial-onset seizures in children was evaluated in one phase II study in children aged from 6 to 16 years (N=123) and one phase III study in children aged from 2 to 18 years (N=304).
Danish: Sikkerhed og virkning af eslicarbazepinacetat som tillægsbehandling til børn med fokale epileptiske anfald blev evalueret i ét fase II-studie hos børn i alderen fra 6 til 16 år (N = 123) og ét fase III-studie hos børn i alderen fra 2 til 18 år (N = 304).
English: Do not breast-feed while you are taking Zebinix.
Danish: De må ikke amme, mens De tager Zebinix.
English: Each ml of oral suspension contains 2.0 mg of methyl parahydroxybenzoate (E218) and approximately 0.00001 mg of sulphites.
Danish: Hver ml oral suspension indeholder 2,0 mg methylparahydroxybenzoat (E218) og ca. 0,00001 mg sulfitter.
English: Plasma levels of eslicarbazepine acetate usually remain below the limit of quantification, following oral administration.
Danish: Plasmaniveauerne af eslicarbazepinacetat forbliver sædvanligvis under kvantificeringsgrænsen efter oral administration.
English: Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily (see section 5.1).
Danish: Nogle patienter i monoterapiregime kan have gavn af en dosis på 1.600 mg en gang dagligt (se pkt.
English: • if 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: Two clusters of ADRs were identified in context of overdose cases - epilepsy/seizures/status epilepticus and cardiac events, mainly arrhythmias.
Danish: To grupper af bivirkninger er blevet identificeret i sammenhæng med overdosissagerepilepsi/anfald/status epilepticus og hjerte-relaterede hændelser, hovedsageligt arytmier.
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: • 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: The safety and efficacy of eslicarbazepine acetate in children aged 6 years and below has not yet been established.
Danish: Eslicarbazepinacetats sikkerhed og virkning hos børn i alderen 6 år og derunder er endnu ikke klarlagt.
English: However, in vitro electrophysiological studies indicate that both eslicarbazepine acetate and its metabolites stabilise the inactivated state of voltage-gated sodium channels, precluding their return to the activated state and thereby preventing 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, hvorved fortsat repetitiv neuronal affyring umuliggøres.
English: - CLCR 30-60 ml/min: initial dose of 200 mg (or 5 mg/kg in children above 6 years) once daily or
Danish: - CLCR 30-60 ml/min: Initialdosis på 200 mg (eller 5 mg/kg hos børn over 6 år) én gang dagligt eller
English: Impairment of fertility was observed in female rats; decreases in implantations and live embryos seen in the mouse fertility study may also indicate effects on female fertility, however, corpora lutea counts were not evaluated.
Danish: De fald i implantationer og levende embryoer, der sås i musefertilitetsstudiet, kan også være tegn på indvirkning på hunlig fertilitet, corpora lutea-antallene blev dog ikke vurderet.
English: Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients.
Danish: Udslæt forekom som bivirkning hos 1,2 % af den samlede population, der blev behandlet med Zebinix, i kliniske studier med epilepsipatienter.
English: Common (may affect up to 1 in 10 people) side effects are:
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 personer):
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, carbamazepine), 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, carbamazepin), bør serumkoncentrationen af natrium undersøges før og under behandling med eslicarbazepinacetat.
English: As a risk to the breast-fed child cannot be excluded breastfeeding should be discontinued during treatment with eslicarbazepine acetate.
Danish: Da det ikke kan udelukkes, at der foreligger en risiko for brystbarnet, bør amningen ophøre under behandling med eslicarbazepinacetat.
English: There is limited data on monotherapy regimen available in the erldely population.
Danish: Der foreligger kun begrænsede data for monoterapi hos den ældre population.
English: • if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients of this medicine (listed in section 6);
Danish: • hvis De er allergisk over for eslicarbazepinacetat, andre carboxamidderivater (f.eks. carbamazepin eller oxcarbazepin, som er medicin til behandling af epilepsi) eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Masking flavour (contains propylene glycol, water and natural and artificial flavouring) Purified water
Danish: Maskerende smagsstof (indeholder propylenglycol, vand og naturlig og kunstig smagstilsætning) Renset vand
English: Zebinix oral suspension contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed) and sulphites which may rarely cause severe hypersensitivity reactions and bronchospasm.
Danish: Zebinix oral suspension indeholder methylparahydroxybenzoat (E218), der kan forårsage allergiske reaktioner (muligvis forsinket), og sulfitter, der i sjældne tilfælde kan forårsage svære overfølsomhedsreaktioner og bronkospasme.
English: Symptoms include decreased level of thyroid hormone levels (seen in blood tests), cold intolerance, large tongue, thin and brittle fingernails or hair and low body temperature;
Danish: Symptomerne omfatter nedsat koncentration af skjoldbruskkirtelhormon (målt i blodprøver) intolerance over for kulde, stor tunge, tynde og skøre fingernegle eller tyndt/skørt hår samt lav kropstemperatur
English: Eslicarbazepine acetate was not teratogenic in the rat or rabbit, but did induce skeletal abnormalities in the mouse.
Danish: Eslicarbazepinacetat var ikke teratogent hos rotten eller kaninen, men det inducerede knogleanormaliteter hos musen.
English: • carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the following side effects of Zebinix may occur in higher frequency: seeing double, abnormal coordination and dizziness;
Danish: • carbamazepin (medicin mod epilepsi), da dosis måske skal justeres, og da hyppigheden af visse bivirkninger ved Zebinix (dobbeltsyn, koordinationsbesvær og svimmelhed) kan øges.
English: Zebinix may make you feel dizzy and/or drowsy, particularly at the beginning of treatment.
Danish: Zebinix kan give svimmelhed og/eller sløvhed særligt i begyndelsen af behandlingen.
English: The pharmacokinetics of eslicarbazepine acetate is linear and dose-proportional in the range 400-1,200 mg both in healthy subjects and patients.
Danish: Eslicarbazepinacetats farmakokinetik er lineær og dosisafhængig i intervallet 400-1.200 mg hos både raske forsøgspersoner og patienter.
English: • phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;
Danish: • phenytoin (medicin mod epilepsi), da dosis muligvis skal justeres.
English: A total of 50 of the 72 subjects starting the study completed the 26-week treatment period that corresponds to a retention rate of 69.4% (see section 4.2 for information on elderly use).
Danish: I alt 50 ud af de 72 forsøgspersoner, som indgik i studiet, gennemførte den 26 ugers behandlingsperiode, hvilket svarer til en retentionsrate på 69,4 % (se pkt.
English: Hyponatraemia has been reported as an adverse reaction in 1.5% of patients treated with Zebinix.
Danish: Hyponatriæmi er indberettet som en bivirkning hos 1,5 % af de patienter, der fik Zebinix.
English: After first opening, oral suspension may be used for up to 2 months Open date: ---/---/--
Danish: Efter den første åbning kan den orale suspension anvendes i 2 måneder.
English: At 1 year, the probability for subjects to withdraw due to either adverse reactions or lack of efficacy was 0.26 for eslicarbazepine acetate and 0.21 for carbamazepine controlled release.
Danish: Ved år 1 var sandsynligheden for, at forsøgspersonerne afbrød behandlingen på grund af enten bivirkninger eller manglende virkning, 0,26 for eslicarbazepinacetat og 0,21 for carbamazepin-depotformulering.
English: Hypertension (including hypertensive crisis), hypotension, orthostatic hypotension, flushing, peripheral coldness
Danish: Hypertension (inklusive hypertensiv krise), hypotension, ortostatisk hypotension, flushing, kolde ekstremiteter
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 Zebinix til patienter med alvorligt nedsat nyrefunktion frarådes pga. utilstrækkelig dokumentation.
English: If they happen to you stop taking Zebinix 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 Zebinix og straks kontakte en læge eller skadestuen, da De kan have behov for akut lægehjælp:
English: The use of Zebinix is associated with an abnormality in ECG (electrocardiogram) called increase in PR interval.
Danish: Brug af Zebinix sættes i forbindelse med en uregelmæssighed på hjertediagrammet (EKG'et), der kaldes forlænget PR-interval.
English: • tricyclic antidepressants e.g. amitriptyline;
Danish: • medicin mod depression (tricykliske antidepressiva) som f.eks. amitriptylin.
English: Symptoms include tremors, pain, cramping;
Danish: Symptomerne omfatter skælven, smerter og kramper
English: • Allergy;
Danish: • allergi
English: Minor metabolites in plasma are Rlicarbazepine 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.