FrancophonIA/ELRC3.0 huggingface dataset:
English: In women being treated for epilepsy, sudden discontinuation of antiepileptic medicine therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Danish: Antiepileptika må ikke seponeres pludseligt hos kvinder, der behandles mod epilepsi, da dette kan føre til gennembrudsanfald, som kan få alvorlige konsekvenser for kvinden og det ufødte barn.
English: Tell the doctor that you are taking Trobalt, well in advance.
Danish: Fortæl det til lægen, at du tager Trobalt, og sig det i god tid i forvejen.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX21.
Danish: Farmakoterapeutisk klassifikation: Antiepileptika, andre antiepileptika, ATC-kode: N03AX21.
English: In the event of overdose, it is recommended that the patient is given appropriate supportive therapy as clinically indicated, including electrocardiogram (ECG) monitoring.
Danish: I tilfælde af overdosering anbefales det, at patienten får en passende understøttende behandling, som klinisk indiceret, herunder overvågning med ekg-optagelser.
English: Trobalt contains the active substance retigabine.
Danish: Trobalt indeholder det aktive stof retigabin.
English: • blood in the urine; abnormally coloured urine
Danish: • blod i urinen, urin med unormal farve
English: Your doctor will monitor you more closely if treatment with Trobalt is continued.
Danish: Lægen vil holde tættere øje med dig, hvis behandlingen med Trobalt fortsættes.
English: Patients (and caregivers of patients) should be advised to seek medical advice if signs of suicidal ideation or behaviour emerge.
Danish: Patienter (og pårørende samt plejepersonale) bør rådgives til at søge lægehjælp, hvis der opstår tegn på selvmordstanker og selvmordsadfærd.
English: Administration of retigabine with a high fat meal resulted in no change in the overall extent of retigabine absorption, but food reduced the between-subject variability in Cmax (23%) compared to the fasted state (41%), and led to an increase in Cmax (38%).
Danish: Administration af retigabin sammen med et måltid med et højt fedtindhold resulterede ikke i ændring i det samlede omfang af absorption af retigabin, men mad reducerede between-subject variability i Cmax (23 %) sammenlignet med fastende tilstand (41 %) og medførte en stigning i Cmax (38 %).
English: Risk related to Trobalt
Danish: Risici ved Trobalt
English: There are no adequate data from the use of retigabine in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data fra anvendelse af retigabin til gravide kvinder.
English: If you are going to have an operation under a general anaesthetic:
Danish: Hvis du skal opereres under fuld bedøvelse:
English: • if you have an existing heart problem • if you have low potassium (hypokalaemia) or low magnesium (hypomagnesaemia) in your
Danish: • hvis du har et lavt niveau af kalium (hypokaliæmi) eller magnesium (hypomagnesiæmi) i blodet
English: In a study of peri- and post-natal development in rats, retigabine was associated with increased perinatal mortality following administration during pregnancy.
Danish: I et studie, hvor den peri- og postnatale udvikling hos rotter blev undersøgt, blev retigabin forbundet med en øget perinatal mortalitet efter administration i drægtighedsperioden.
English: You must talk to your doctor about the effect of your epilepsy on driving and using machines.
Danish: Tal med lægen om, hvordan din epilepsi påvirker din evne til at føre motorkøretøj og arbejde med maskiner.
English: The gall bladder distension in the dog resulted in focal compression of the liver.
Danish: Udspilingen af galdeblæren hos hunden resulterede i fokal sammenpresning af leveren.
English: Therapy with multiple antiepileptic medicinal products is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be used whenever possible.
Danish: Behandling med flere antiepileptika er forbundet med en højere risiko for medfødte misdannelser end monoterapi, og derfor bør monoterapi altid benyttes, når det er muligt.
English: In a population pharmacokinetic analysis, retigabine clearance increased with increasing body surface area.
Danish: I en populationsfarmakokinetisk analyse steg clearance for retigabin med stigende kropsoverfladeareal.
English: It is recommended that patients are advised about the risk of such adverse reactions at treatment initiation and following each titration step, and that they are advised not to drive or operate machinery until they have established how Trobalt affects them.
Danish: Det anbefales, at patienter informeres om risikoen for sådanne bivirkninger i starten af behandlingsforløbet og efter hvert titreringstrin, samt at de instrueres i ikke at føre motorkøretøj og betjene maskiner, før de ved, hvordan Trobalt påvirker dem.
English: Trobalt is indicated as adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalization in patients aged 18 years or older with epilepsy, where other appropriate combinations with other medicinal products have proved inadequate or have not been tolerated.
Danish: Trobalt er indiceret som tillægsbehandling ved lægemiddelresistente partielle epileptiske anfald med eller uden sekundær generalisering hos voksne i alderen 18 år og derover, hvor andre passende kombinationer med andre lægemidler har vist sig utilstrækkelige eller ikke tåles.
English: Eye disorders have been observed with the use of Trobalt, including pigment changes in the retina.
Danish: Øjensygdomme er set ved brug af Trobalt, herunder pigmentændringer i retina.
English: Across all studies, patients had a mean duration of epilepsy of 22 years and a median baseline seizure frequency ranging from 8 to 12 per 28 days.
Danish: Patienterne havde på tværs af alle studierne haft epilepsi i gennemsnitligt 22 år og en medianfrekvens af anfald ved baseline på 8-12 pr. 28 dage.
English: Mutations in the KCNQ channels underlie several human inheritable disorders, including epilepsy (KCNQ2 and 3).
Danish: Mutationer i KCNQ-kanalerne ligger til grund for flere arvelige forstyrrelser hos mennesker, herunder epilepsi (KCNQ2 og KCNQ3).
English: Tell your doctor as soon as possible if you get any of these symptoms.
Danish: Fortæl det hurtigst muligt til lægen, hvis du får et eller flere af disse symptomer.
English: Data from an in vitro study showed that the N-acetyl metabolite of retigabine (NAMR) inhibited P-glycoprotein-mediated transport of digoxin in a concentration-dependent manner.
Danish: Data fra et in vitro-studie viste, at N-acetyl-metabolitten af retigabin (NAMR) hæmmede den Pglycoprotein-medierede transport af digoxin på en koncentrationsafhængig måde.
English: In pooled safety data from three multicentre, randomised, double-blind, placebo-controlled studies, adverse reactions were generally mild to moderate in intensity, and were most commonly reported in the first 8 weeks of treatment.
Danish: Sammenlagte sikkerhedsdata fra tre randomiserede, dobbeltblindede, placebokontrollerede multicenterstudier viste, at bivirkningerne generelt var milde til moderate i intensitet og hyppigst blev rapporteret i de første 8 uger af behandlingen.
English: 6.6 Special precautions for disposal No special requirements.
Danish: 6.6 Regler for destruktion Ingen særlige forholdsregler.
English: The effect of food on Cmax under usual clinical conditions is not expected to be clinically relevant.
Danish: Fødepåvirkning af Cmax under sædvanlige kliniske forhold anses ikke for at være klinisk relevant.
English: Absolute oral bioavailability of retigabine relative to an intravenous dose is approximately 60%.
Danish: Den absolutte biotilgængelighed af oralt administreret retigabin i forhold til intravenøs dosering er ca. 60 %.
English: Retigabine pharmacokinetics are essentially linear over the single-dose range of 25 to 600 mg in healthy volunteers and up to 1,200 mg daily in patients with epilepsy, with no unexpected accumulation following repeated administration.
Danish: Farmakokinetikken for retigabin er essentielt lineær over enkeltdosis-intervallet fra 25 til 600 mg hos raske frivillige forsøgspersoner og op til 1.200 mg daglig hos patienter med epilepsi, og der er ingen uventet akkumulation efter gentagen administration.
English: Vision abnormalities (field constriction, loss of central sensitivity, and reduced visual acuity) have been reported.
Danish: Synsabnormaliteter (begrænsning i synsfelt, tab af central følsomhed og nedsat synsskarphed) er rapporteret.
English: An open-label, multiple dose pharmacokinetic, safety and tolerability study in five subjects aged between 12 years to less than 18 years with partial onset seizures determined that the pharmacokinetics of retigabine in adolescents were consistent with the pharmacokinetics of retigabine in adults.
Danish: Et åbent, multidosis, farmakokinetisk sikkerheds- og tolerabilitetsstudie hos fem forsøgspersoner i alderen fra 12 år til under 18 år med partielle epileptiske anfald påviste, at retigabins farmakokinetik hos unge var sammenlignelig med farmakokinetikken hos voksne.
English: Retigabine was statistically significantly superior to placebo at 600 mg/day (one study), 900 mg/day (two studies) and 1,200 mg/day (two studies).
Danish: Retigabin var statistisk signifikant bedre end placebo, ved dosis på 600 mg/dag (ét studie), 900 mg/dag (to studier) og 1.200 mg/dag (to studier).
English: However, there was no apparent gender difference in weight-normalized clearance, and since retigabine is titrated according to individual patient response and tolerability, dose-adjustments are not required on the basis of gender.
Danish: Der var dog ingen klar forskel i den vægt-normaliserede clearance mellem kønnene, og da retigabin titreres i henhold til den enkelte patients respons og tolerance, er det ikke nødvendigt at foretage dosisjusteringer på grundlag af kønnet.
English: In retigabine-treated patients in the pooled dataset, confusional state was reported in 9% of patients, hallucinations in 2% of patients and psychotic disorders in 1% of patients (see section 4.4).
Danish: I det samlede datasæt over patienter, der blev behandlet med retigabin, blev der rapporteret om konfusion hos 9 % af patienterne, hallucinationer hos 2 % af patienterne og psykotiske forstyrrelser hos 1 % af patienterne (se pkt.
English: Very common side effects These may affect more than 1 in 10 people:
Danish: Meget almindelige bivirkninger Disse kan forekomme hos flere end 1 ud af 10 personer:
English: A mean increase in Individual Corrected QT Interval (QTcI) of up to 6.7 ms (upper bound of 95% one-sided CI 12.6 ms) was observed within 3 hours of dosing.
Danish: En gennemsnitlig stigning af Individual Corrected QT Interval (QTcl) på op til 6,7 ms (øvre grænse for 95 % ensidet konfidensinterval var 12,6 ms) blev observeret inden for 3 timer efter dosering.
English: The safety and efficacy of retigabine in children below 18 years of age has not yet been established (see section 5.2).
Danish: Retigabins sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt (se pkt.
English: The safety and efficacy of doses higher than 1,200 mg/day have not been established.
Danish: Sikkerheden og virkningen af doser højere end 1.200 mg/dag er ikke fastlagt.
English: The total clearance of retigabine from plasma following intravenous dosing is typically 0.4 to 0.6 l/h/kg.
Danish: Den totale clearance af retigabin fra plasma efter intravenøs dosering er typisk 0,4-0,6 l/t./kg.
English: It is recommended that patients are advised about the possible effects on vision if they take Trobalt with alcohol.
Danish: Det anbefales, at patienter informeres om den mulige påvirkning af synet, hvis de drikker alkohol, mens de er i behandling med Trobalt.
English: Caution should be taken when Trobalt is prescribed with medicinal products known to increase QT interval and in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are 65 years of age and above.
Danish: Der bør udvises forsigtighed ved ordinering af Trobalt sammen med lægemidler, som er kendt for at forlænge QT-intervallet, og hos patienter med kendt langt QT-interval, kongestiv hjerteinsufficiens, ventrikelhypertrofi, hypokaliæmi eller hypomagnesiæmi samt hos patienter, der er 65 år eller ældre.
English: In patients who develop these changes, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
Danish: Hvis patienten, der udvikler disse forandringer, må behandling med Trobalt kun fortsættes efter en grundig reevaluering af fordele og risici.
English: Always take this medicine exactly as your doctor has told you to.
Danish: Tag altid lægemidlet nøjagtigt efter lægens anvisning.
English: Tell your doctor immediately if you get any of these symptoms.
Danish: Fortæl det straks til lægen, hvis du får et eller flere af disse symptomer.
English: In addition to adverse reactions seen at therapeutic doses, symptoms of retigabine overdose included agitation, aggressive behaviour and irritability.
Danish: Ud over de bivirkninger, der er set ved administration af terapeutiske doser, omfattede symptomerne på overdosering af retigabin agitation, aggressiv adfærd og irritabilitet.
English: Patients were randomized to placebo or retigabine at 600, 900 or 1,200 mg/day (see Table 1).
Danish: Patienterne blev randomiseret til placebo eller doser af retigabin på 600, 900 eller 1.200 mg/dag (se tabel 1).
English: Consequently, the efficacy and safety of retigabine when taken concomitantly with antiepileptic medicinal products that were less commonly used as background treatment in the clinical studies, including levetiracetam, has not been definitely shown.
Danish: Virkningen og sikkerheden af retigabin taget sammen med antiepileptika, som mindre ofte blev anvendt som baggrundsbehandling i de kliniske studier, herunder levetiracetam, er derfor ikke blevet påvist med sikkerhed.
English: There was no evidence of teratogenicity following administration of retigabine to pregnant animals during the period of organogenesis.
Danish: Der blev ikke observeret teratogenicitet efter administration af retigabin til drægtige dyr i perioden med organogenese.
English: When applicable, a cover letter highlighting the main changes should also be included as part of the educational materials.
Danish: Når det er relevant, skal uddannelsesmaterialet inkludere et følgebrev, der fremhæver de vigtigste ændringer.
English: Croscarmellose sodium Hypromellose Magnesium stearate Microcrystalline cellulose.
Danish: Croscarmellosenatrium Hypromellose Magnesiumstearat Mikrokrystallinsk cellulose.
English: Based on a study conducted in healthy volunteers, therapeutic doses of retigabine (600-1,200 mg/day) resulted in a minor (8-18%) increase in digoxin AUC following a single oral dose of digoxin.
Danish: Baseret på et studie med raske frivillige resulterede terapeutiske doser af retigabin (600-1.200 mg/dag) i en mindre (8-18%) stigning i digoxin-AUC efter en enkelt oral digoxindosis.
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 desuden vist, at der er en let forøget risiko for selvmordstanker og selvmordsadfærd.
English: Do not use this medicine after the expiry date which is stated on the pack.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • tremors; sudden jerking of muscles (myoclonus)
Danish: • rystelser/tremor, pludselige muskelsammentrækninger (myoclonus)
English: Thereafter, the total daily dose is increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
Danish: Herefter øges den totale daglige dosis med maksimalt 150 mg hver uge alt efter den enkelte patients respons og tolerance.
English: The most frequently reported defects are cleft lip, cardiovascular malformations and neural tube defects.
Danish: De hyppigst indberettede misdannelser er læbespalte, kardiovaskulære misdannelser og neuralrørsdefekter.
English: An effective maintenance dose is expected to be between 600 mg/day and 1,200 mg/day.
Danish: En effektiv vedligeholdelsesdosis forventes at ligge mellem 600 mg/dag og 1.200 mg/dag.
English: In vitro studies using human liver microsomes showed little or no potential for retigabine to inhibit the major cytochrome P450 isoenzymes (including CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5).
Danish: In vitro-studier, hvor der blev anvendt humane levermikrosomer, viste, at retigabin havde et lille eller intet potentiale til at hæmme de primære cytochrom P450-isoenzymer (herunder CYP 1A2, CYP 2A6, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 og CYP 3A4/5).
English: These findings were apparent at exposure levels lower than those obtained with clinically recommended doses and were accompanied by maternal toxicities (including ataxia, hypokinesia, tremor and reduced body weight gain).
Danish: Disse fund blev åbenlyse ved lavere eksponeringsniveau end dem, der blev opnået ved de anbefalede kliniske doser og var forbundet med maternal toksicitet (herunder ataksi, hypokinesi, tremor og reduceret øgning af kropsvægten).
English: In rats, retigabine and/or its metabolites crossed the placenta resulting in tissue concentrations that were similar in dams and foetuses.
Danish: Hos rotter passerede retigabin og/eller dets metabolitter placenta, hvilket resulterede i vævskoncentrationer, der var af samme størrelsesorden hos moderdyrene og i fostrene.
English: In addition, retigabine was effective in preventing status epilepticus seizures in rodents with cobalt-induced epileptogenic lesions, and inhibiting tonic extensor seizures in genetically susceptible mice.
Danish: Derudover forhindrede retigabin effektivt status epilepticusanfald hos gnavere med cobolt-inducerede epileptogene læsioner og hæmmede toniske anfald i ekstensorer hos genetisk disponerede mus.
English: These effects generally occurred within the first 8 weeks of treatment, and frequently led to treatment withdrawal in affected patients.
Danish: Disse bivirkninger forekom generelt inden for de første 8 uger af behandlingen og førte hyppigt til seponering af behandlingen hos de pågældende patienter.
English: Animal studies have shown excretion of retagabine and/or its metabolites in breast milk.
Danish: Dyrestudier har vist, at retigabin og/eller dets metabolitter udskilles i modermælken.
English: Approximately 30-40% of clinical trial subjects who were being treated with retigabine and underwent a skin and/or ophthalmological examination had findings of discolouration of nails, lips, skin and/or mucosa or non-retinal ocular pigmentation, and approximately 15-30% of clinical trial subjects who were being treated with retigabine and underwent an ophthalmological examination had retinal pigmentation findings.
Danish: Omkring 30-40 % af de personer i de kliniske forsøg, som blev behandlet med retigabin, og som fik foretaget hudundersøgelse og/eller oftamologisk undersøgelse, havde misfarvning af negle, læber, hud og/eller slimhinder eller ikke-retinale pigmentforandringer i øjnene, og ca. 15-30 % af de personer i de kliniske forsøg, som blev behandlet med retigabin, og som fik foretaget en oftamologisk undersøgelse, havde retinale pigmentforandringer.
English: Opaque PVC-PVDC-aluminium foil blisters.
Danish: Uigennemsigtig PVC-PVDC-aluminiumsfolieblister.
English: The steady state volume of distribution of retigabine is 2 to 3 l/kg following intravenous dosing.
Danish: Retigabins fordelingsvolumen ved steady state er 2 til 3 l/kg efter intravenøs dosering.
English: No dose adjustment of digoxin is needed.
Danish: Justering af digoxindosis er ikke nødvendig.
English: This stabilises the resting membrane potential and controls the sub-threshold electrical excitability in neurons, thus preventing the initiation of epileptiform action potential bursts.
Danish: Dette stabiliserer membranens hvilepotentiale, og kontrollerer neuronets sub-threshold excitabilitet, så initiering af epileptiforme aktionspotentialer forhindres.
English: • A physician's guide to prescribing.
Danish: • Ordineringsvejledning til lægen.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Do not stop treatment without discussing it with your doctor.
Danish: Du må ikke stoppe behandlingen uden først at have talt med lægen.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Trobalt should be made taking into account the benefit of breast-feeding to the child and the benefit of Trobalt therapy to the woman.
Danish: Ved beslutning om, hvorvidt amningen skal fortsætte eller ophøre, eller behandling med Trobalt skal fortsætte eller ophøre, bør der tages højde for barnets fordel ved at blive ammet og moderens fordel ved behandling med Trobalt.
English: When withdrawing Trobalt, the dose must be gradually reduced over a period of at least 3 weeks (see section 4.4).
Danish: Når Trobalt seponeres, skal doseringen gradvist reduceres over en periode på mindst 3 uger (se pkt.
English: Elimination of retigabine occurs via a combination of hepatic metabolism and renal excretion.
Danish: Retigabin elimineres gennem en kombination af hepatisk metabolisering og renal udskillelse.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for retigabine.
Danish: Mekanismen for denne risiko kendes ikke, og muligheden for en forøget risiko ved behandling med retigabin kan ikke udelukkes ud fra de foreliggende data.
English: If you miss any doses, just take one dose as soon as you remember.
Danish: Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det.
English: In vitro studies indicate that retigabine acts primarily through opening neuronal potassium channels (KCNQ2 [Kv7.2] and KCNQ3 [Kv7.3]).
Danish: In vitro-studier indikerer, at retigabin primært virker ved at åbne neuronale kaliumkanaler af typen KCNQ2 [Kv7.2] og KCNQ3 [Kv7.3].
English: Tell your doctor if you experience any changes in vision whilst you are being treated with Trobalt.
Danish: Fortæl lægen, hvis du oplever synsforandringer, mens du er i behandling med Trobalt.
English: The maximum total maintenance dose is 1,200 mg/day.
Danish: Den maksimale totale vedligeholdelsesdosis er 1.200 mg/dag.
English: Co-administration of ethanol (1.0 g/kg) with retigabine (200 mg) resulted in an increase in visual blurring in healthy volunteers.
Danish: Samtidig administration af ethanol (1,0 g/kg) og retigabin (200 mg) resulterede i en øget forekomst af tågesyn hos raske frivillige forsøgspersoner.
English: Maximum doses in repeat dose toxicity studies were limited by the exaggerated pharmacologic effects of retigabine (including ataxia, hypokinesia and tremor).
Danish: Maksimumsdoser i toksicitetsstudier med gentagne doser var begrænsede af retigabins udtalte farmakologiske virkninger (herunder ataksi, hypokinesi og tremor).
English: This analysis also showed no clinically significant effect of the inducers (phenytoin, carbamazepine and phenobarbital) on retigabine clearance.
Danish: Yderligere viste denne analyse ingen klinisk signifikant påvirkning af induktorer (phenytoin, carbamazepin og phenobarbital) på retigabins clearance.
English: Hypokinesia
Danish: Hypokinesi
English: Confusional state Psychotic disorders Hallucinations Disorientation Anxiety
Danish: Psykotiske forstyrrelser Hallucinationer Desorientering
English: Retigabine has been shown to interfere with clinical laboratory assays of both serum and urine bilirubin, which can result in falsely elevated readings.
Danish: Det er vist, at retigabin interagerer med laboratorieanalyser af både serum- og urinbilirubin, hvilket kan resultere i falsk forhøjede værdier.