FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may gradually adjust your dose over a few weeks so that your seizures are better controlled, and side effects are kept to a minimum.
Danish: Lægen kan gradvist tilpasse din dosis over nogle få uger, så dine anfald bliver bedre kontrolleret, og bivirkningerne holdes på et minimum.
English: Trobalt can affect the results of some tests.
Danish: Trobalt kan påvirke resultaterne af enkelte undersøgelser.
English: Tell the person who orders the test that you are taking Trobalt.
Danish: Fortæl den person, der bestiller prøven, at du tager Trobalt.
English: Then leave at least 3 hours before your next dose.
Danish: Herefter skal der gå mindst 3 timer, før du tager den næste dosis.
English: The need for treatment with antiepileptic medicinal products should be reviewed when a woman is planning to become pregnant.
Danish: Behovet for behandling med antiepileptika bør vurderes, når en kvinde planlægger at blive gravid.
English: • feeling agitated, aggressive or irritable
Danish: • ophidselse, aggressivitet eller irritabilitet
English: You may need extra check-ups (including an electrocardiogram [ECG], which is a test which records the electrical activity of your heart) while
Danish: Det kan være, at det er nødvendigt for dig at komme til ekstra kontrol (herunder elektrokardiogram (ekg), som er en undersøgelse, der registrerer dit hjertes elektriske aktivitet) mens du tager
English: Trobalt is one of a group of medicines called antiepileptics.
Danish: Trobalt tilhører en gruppe af lægemidler, der kaldes antiepileptika.
English: Therefore, based upon the safety profile of Trobalt the CHMP concluded that the MAH should submit one additional renewal application in 5 years.
Danish: Baseret på sikkerhedsprofilen for Trobalt, konkluderer CHMP at MAH skal indsende en yderligere ansøgning om forlængelse om 5 år.
English: Your doctor may decide that Trobalt is not suitable for you.
Danish: Lægen kan beslutte, at Trobalt ikke er velegnet til dig.
English: • psychotic disorders (severe mental health problems)
Danish: • psykotiske tilstande (svære psykiske problemer)
English: Elderly If you are 65 years or older, you may be more likely than a younger adult to get the following symptoms:
Danish: Hvis du er 65 år eller ældre, kan du have større risiko end yngre personer for at få følgende symptomer:
English: A small number of people being treated with antiepileptics such as Trobalt have had thoughts of harming or killing themselves.
Danish: Et lille antal personer, der er blevet behandlet med antiepileptika, som f.eks. Trobalt, har haft tanker om at skade sig selv eller begå selvmord.
English: Non-clinical data reveal no special hazard for humans based on studies of genotoxicity or carcinogenic potential.
Danish: Nonkliniske data viser ingen særlig risiko for mennesker vurderet ud fra studier af genotoksicitets- og karcinogenicitetspotentiale.
English: The studies were not designed to evaluate specific combinations of antiepileptic medicinal products.
Danish: Studierne var ikke designet med det formål at vurdere specifikke kombinationer af antiepileptika.
English: If you have kidney or liver problems, your doctor may give you a reduced dose of Trobalt.
Danish: Hvis du har nyre- eller leverproblemer, kan lægen give dig en lavere dosis af Trobalt.
English: • if you have kidney or liver problems.
Danish: • hvis du har nyre- eller leverproblemer.
English: If you notice such changes while taking the medicine, tell your doctor.
Danish: Hvis du bemærker sådanne forandringer, mens du tager medicinen, skal du tale med lægen.
English: In some cases changes to the pigmentation in the eyes may improve after you stop taking Trobalt.
Danish: I nogle tilfælde kan ændringer i øjets pigment blive bedre, efter du stopper med at tage Trobalt.
English: This is more likely to affect you:
Danish: Der er større risiko for dette:
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Trobalt remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Danish: Baseret på data, der er blevet tilgængeligt efter godkendelse af den intiale markedsføringstilladelse, vurderer CHMP at benefit-risk balancen for Trobalt fortsat er positiv, men at sikkerhedsprofilen skal monitoreres nøje af følgende årsager:
English: Glaxo Wellcome, S.A, Avda.
Danish: Fremstiller Glaxo Wellcome, S.A, Avda.
English: If you are over 65 years you will usually be given a reduced starting dose and your doctor may limit the maximum dose to 900 mg a day.
Danish: Hvis du er over 65 år, vil du normalt blive givet en lavere startdosis og din læge kan sætte din maksimale dosis ned til 900 mg om dagen.
English: The risk of congenital malformations is increased by a factor of 2 to 3 in the offspring of mothers treated with antiepileptic medicinal products compared with the expected incidence in the general population of approximately 3%.
Danish: Risikoen for medfødte misdannelser øges med en faktor 2 til 3 hos børn af mødre, der behandles med antiepileptika, i forhold til den forventede incidens på ca. 3 % hos den almene befolkning.
English: Trobalt is used to treat seizures that affect one part of the brain (partial seizure), which may or may not extend to larger areas on both sides of the brain (secondary generalisation).
Danish: Trobalt anvendes til behandling af anfald, der påvirker én del af hjernen (partielle anfald), der evt. kan udvides til større områder i begge sider af hjernen (sekundær generalisering).
English: The eye examination should be repeated at least every six months whilst taking Trobalt.
Danish: Øjenundersøgelsen skal gentages mindst hvert halve år, så længe du tager Trobalt.
English: A substantial fraction of the retigabine dose is converted to inactive N-glucuronides.
Danish: En væsentlig del af retigabin-dosis omdannes til inaktive N-glucuronider.
English: • if you are 65 years of age or above
Danish: • hvis du er 65 år eller derover
English: • memory problems
Danish: • hukommelsesproblemer
English: Date of latest renewal: 14 January 2016
Danish: Dato for første markedsføringstilladelse: 28. marts 2011 Dato for seneste fornyelse: 14. januar 2016
English: There are only limited data on the safety and efficacy of retigabine in patients aged 65 years and above.
Danish: Der foreligger kun begrænsede data for sikkerhed og virkning af retigabin hos patienter i alderen 65 år og derover.
English: The percentage decrease in plasma concentration during dialysis ranged from 34% to 60% except for one subject who had a 17% reduction.
Danish: Det procentvise fald i plasmakoncentrationen under dialyse var fra 34 % til 60 % med undtagelse af en person, der havde 17 % reduktion.
English: In open-label extensions of the three placebo-controlled studies, persistence of efficacy was maintained over an evaluation period of at least 12 months (365 patients).
Danish: I åbne forlængelser af de tre placebokontrollerede studier blev en vedvarende virkning bibeholdt over en evalueringsperiode på mindst 12 måneder (365 patienter).
English: NAMR has antiepileptic activity, but is less potent than retigabine in animal seizure models.
Danish: NAMR har antiepileptisk aktivitet, men er mindre potent end retigabin i dyremodeller af epilepsi.
English: What Trobalt contains
Danish: Trobalt indeholder
English: This is most likely to happen during the first few months of treatment with Trobalt.
Danish: Dette sker oftest i løbet af de første få måneders behandling med Trobalt.
English: This sometimes occur together with discolouration of parts of the eye.
Danish: Dette kan i nogle tilfælde forekomme sammen med misfarvning af dele af øjet.
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Patienter bør derfor monitoreres for tegn på selvmordstanker og selvmordsadfærd, og hensigtsmæssig behandling bør overvejes.
English: The long-term prognosis of these findings is currently unknown, but some of the reports have been associated with visual impairment.
Danish: Langtidsprognosen for disse fund er endnu ukendt, men i nogle rapporter har det været forbundet med nedsat syn.
English: You may become aware of blurring of your central vision and notice trouble with reading or recognizing faces.
Danish: Du kan blive opmærksom på sløret centralt syn og have problemer med at læse eller genkende ansigtet.
English: The clinical significance of this finding is not known.
Danish: Den kliniske signifikans af dette fund kendes ikke.
English: If breakthrough seizures occur towards the end of dialysis then an additional supplemental dose may be considered at the start of subsequent dialysis sessions.
Danish: Hvis der opstår gennembrudsanfald hen imod slutningen af dialysen, bør en yderligere supplerende dosis overvejes ved starten af efterfølgende dialyser.
English: You must look out for certain symptoms while you are taking Trobalt, to reduce the risk of any problems.
Danish: Du skal holde øje med bestemte symptomer, mens du tager Trobalt, for at nedsætte risikoen for problemer.
English: Interaction with alcohol
Danish: Interaktion med alkohol
English: phenobarbital, phenytoin, pregabalin, topiramate, valproate, zonisamide.
Danish: phenobarbital, phenytoin, pregabalin, topiramat, valproat og zonisamid.
English: It is recommended that patients are advised about the risk of these possible effects.
Danish: Det anbefales, at patienterne informeres om risikoen for disse mulige bivirkninger.
English: If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember.
Danish: Hvis patienter undlader at tage en eller flere doser, anbefales det, at de tager en enkelt dosis, så snart de kommer i tanke om det.
English: When Cmax was normalized for weight, the values were approximately 30% higher in young females than in males and 40% higher in elderly females compared with males.
Danish: Når Cmax blev normaliseret for vægt, var værdierne ca. 30 % højere hos unge kvinder end hos mænd og 40 % højere hos ældre kvinder end hos mænd.
English: The increase did not appear to be dependent on retigabine dose and is not considered clinically relevant.
Danish: Stigningen syntes ikke at være afhængig af retigabindosis og anses ikke som klinisk relevant.
English: Don't drive or use machines until you know how Trobalt affects you.
Danish: Lad være med at føre motorkøretøj eller arbejde med maskiner, før du ved, hvordan Trobalt påvirker dig.
English: If you need a blood or urine test:
Danish: Hvis du skal have taget en blod- eller urinprøve:
English: Trobalt is not recommended for children and adolescents aged under 18.
Danish: Trobalt er ikke anbefalet til børn under 18 år.
English: Like all medicines, Trobalt can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: However, this effect is not considered clinically significant, therefore no adjustment of the Trobalt dose is recommended.
Danish: Denne virkning anses dog ikke for at være klinisk signifikant, og derfor anbefales der ingen dosisjustering af Trobalt.
English: Potassium channels are one of the voltage-gated ion channels found in neuronal cells and are important determinants of neuronal activity.
Danish: Kaliumkanaler er én af flere spændingsstyrede ionkanaler, der findes i neuronale celler, og de er vigtige determinanter af neuronal aktivitet.
English: Trobalt can cause serious side effects, including an inability to pass urine (urinary retention) and mental health problems.
Danish: Trobalt kan give alvorlige bivirkninger, herunder manglende evne til at lade vandet (urinretention) og psykiske problemer.
English: The tablets must be taken in three divided doses each day.
Danish: Tabletterne skal indtages fordelt på tre doser hver dag.
English: If you need a blood or urine test
Danish: Hvis du skal have taget en blod- eller urinprøve
English: However, steady-state data from a limited number of patients in smaller phase II studies indicated that: - phenytoin can reduce retigabine systemic exposure by 35% - carbamazepine can reduce retigabine systemic exposure by 33%
Danish: Steady state data fra et begrænset antal patienter i mindre fase II-studier indikerede dog at: - phenytoin kan reducere den systemiske eksposition for retigabin med 35 % - carbamazepin kan reducere den systemiske eksposition for retigabin med 33 %.
English: Do not take Trobalt • if you are allergic to retigabine or any of the other ingredients of Trobalt (listed in section 6).
Danish: Tag ikke Trobalt • hvis du er allergisk over for retigabin eller et af de øvrige indholdsstoffer i Trobalt (angivet i
English: If you take more Trobalt than you should If you take too many tablets of Trobalt, you may be more likely to have side effects, or any of these symptoms:
Danish: Hvis du har taget for meget Trobalt Hvis du har taget for mange Trobalt tabletter, kan du have større risiko for at opleve bivirkninger eller nogle af disse symptomer:
English: The rate of progression of vitelliform maculopathy and its impact on retinal and macular function and vision is unclear.
Danish: Hastigheden som vitelliform maculopati udvikler sig med og dets påvirkning af retinal og makulær funktion og syn er usikker.
English: There is no information about the safety of Trobalt in pregnant women.
Danish: Der er ingen information omkring sikkerheden af Trobalt hos gravide kvinder.
English: Take extra care until you know how Trobalt and alcohol affect you.
Danish: Vær ekstra forsigtig, indtil du ved, hvordan Trobalt sammen med indtagelse af alkohol påvirker dig.
English: In addition, a single supplemental dose is recommended immediately after haemodialysis.
Danish: En enkelt, supplerende dosis anbefales desuden umiddelbart efter hæmodialyse.
English: In vitro data indicated a low potential for interaction with other antiepileptic medicinal products (see section 5.2).
Danish: In vitro data indikerede et lavt potentiale for interaktion med andre antiepileptika (se pkt.
English: The requirements for submission of periodic safety updates reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR) Kravene for indsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel er fastsat på listen over EU-referencedatoer (EURD list) i artikel 107c, stk. 7, i direktiv 2001/83/EF og efterfølgende opdateringer, offentliggjort på den europæiske webportal for lægemidler.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glaxo Group Limited
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Glaxo Group Limited
English: Retigabine also displayed inhibitory properties in multiple kindling models, for example, in the fully kindled state and in some cases during the kindling development.
Danish: Retigabin viste også hæmmende egenskaber i flere kindling-modeller, for eksempel i den fuldt kindlede tilstand og i nogle tilfælde under udviklingen af kindling.
English: Heart conditions Trobalt can affect heart rhythm.
Danish: Hjertelidelser Trobalt kan påvirke hjerterytmen.
English: Your doctor should recommend that you have an eye examination before starting treatment.
Danish: Lægen vil anbefale, at du får lavet en øjenundersøgelse, før behandlingen startes.
English: A reduction in the initial and maintenance dose of Trobalt is recommended in elderly patients.
Danish: Det anbefales at reducere start- og vedligeholdelsesdosis af Trobalt hos ældre patienter.
English: GROUDS FOR ONE ADDITIONAL RENEWAL
Danish: BEGRUNDELSE FOR EN YDERLIGERE FORLÆNGELSE
English: Trobalt can make you feel dizzy or drowsy and cause double or blurred vision.
Danish: Trobalt kan gøre dig svimmel eller døsig og kan give dobbeltsyn eller sløret syn.
English: If you stop taking Trobalt
Danish: Hvis du holder op med at tage Trobalt
English: Retigabine is approximately 80% bound to plasma protein over the concentration range of 0.1 to 2 µg/ml.
Danish: Retigabin er ca. 80 % bundet til plasmaprotein over koncentrationsintervallet fra 0,1 til 2 µg/ml.
English: It is not known whether the active substance of Trobalt can pass into breast-milk.
Danish: Det vides ikke, om det aktive stof i Trobalt kan gå over i modermælken.
English: Trobalt must be used with caution in patients at risk of urinary retention, and it is recommended that patients are advised about the risk of these possible effects.
Danish: Trobalt skal anvendes med forsigtighed hos patienter, der har en risiko for at få urinretention, og det anbefales, at patienterne informeres om risikoen for disse mulige bivirkninger.
English: Talk to your doctor before taking Trobalt:
Danish: Kontakt lægen, før du tager Trobalt:
English: The tablets should be swallowed whole, and not chewed, crushed or divided.
Danish: Tabletterne skal synkes hele og må ikke tygges, knuses eller brækkes over.
English: Trobalt is for oral use.
Danish: Trobalt er til oral anvendelse.
English: * Statistically significant, p≤0.05 ~ Dose not studied
Danish: * Statistisk signifikant, p ≤ 0,05.
English: Tell your doctor if any of these applies to you.
Danish: Fortæl det til lægen, hvis noget af ovenstående gælder for dig.
English: In addition, there was a delay in auditory startle response development.
Danish: Derudover var der en forsinket udvikling af afkommets startle response.
English: C OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Retigabine has a plasma half-life of approximately 6 to 10 hours.
Danish: Retigabin har en plasmahalveringstid på ca. 6-10 timer.
English: If you forget to take Trobalt
Danish: Hvis du har glemt at tage Trobalt
English: Symptoms and signs There is limited experience of overdose with retigabine.
Danish: Symptomer og tegn Der er begrænset erfaring med overdosering af retigabin.
English: In addition, cases of acquired vitelliform-type maculopathy have been identified, both in clinical studies and as spontaneous reports.
Danish: Derudover er der identificeret tilfælde af erhvervet maculopati af vitelliformtypen, både i kliniske studier og som spontane indberetninger.
English: Oral contraceptives
Danish: Orale kontraceptiva
English: • not being able to pass urine (urinary retention).
Danish: • manglende evne til at lade vandet (urinretention).
English: Retigabine is also metabolised to an N-acetyl metabolite (NAMR) that is also subsequently glucuronidated.
Danish: Retigabin metaboliseres desuden til en N-acetyl-metabolit (NAMR), som også efterfølgende glucuroniseres.
English: After both single and multiple oral doses, retigabine is rapidly absorbed with median tmax values generally between 0.5 and 2 hours.
Danish: Efter både enkeltdoser og gentagne doser administreret oralt absorberes retigabin hurtigt med medianværdier af tmax generelt på mellem 0,5 og 2 timer.
English: Don't take any more Trobalt than your doctor has recommended.
Danish: Du må ikke tage mere Trobalt, end lægen har foreskrevet.
English: A total of approximately 84% of the dose is recovered in the urine, including the N-acetyl metabolite (18%), N-glucuronides of the parent active substance and of the N-acetyl metabolite (24%), or parent active substance (36%).
Danish: I alt ca. 84 % af dosis genfindes i urinen, herunder N-acetyl-metabolitten (18 %), N-glucuronider af det aktive stof og af N-acetyl-metabolitten (24 %) eller uomdannet aktivt stof (36 %).
English: Uncertainties about the impact of this risk on patients remain as there is a possibility of functional abnormalities associated with retinopathy including potentially severe visual impairment.
Danish: Usikkerheden omkring betydningen af denne risiko for patienterne vedbliver, da der er risiko for funktionelle abnormaliteter forbundet med retinopati, herunder mulig alvorlig synsnedsættelse.
English: • tingling or numbness of the hands or feet
Danish: • prikken eller følelsesløshed i hænderne eller fødderne
English: However, efficacy and safety of retigabine have not been determined in adolescents.
Danish: Retigabins virkning og sikkerhed er imidlertid ikke klarlagt hos unge.
English: Only 14% of retigabine is excreted in the faeces.
Danish: Kun 14 % af retigabindosis udskilles i fæces.
English: Trobalt is not recommended during pregnancy and in women of childbearing age, not using contraception.
Danish: Trobalt anbefales ikke under graviditet og til kvinder i den fødedygtige alder, der ikke anvender prævention.
English: It is used together with other anti-epileptic medicines to treat adults who continue to experience seizures and where other combinations of antiepileptic medicines have not worked well.
Danish: Det anvendes sammen med andre antiepileptiske lægemidler til behandling af voksne, der fortsat oplever anfald og hvor andre kombinationer af antiepileptisk medicin ikke har tilstrækkelig virkning.
English: There was no meaningful change in digoxin Cmax.
Danish: Der var ingen klinisk relevant ændring i digoxins Cmax.
English: Don't stop taking Trobalt without advice Take Trobalt for as long as your doctor recommends.
Danish: Du må ikke holde op med at tage Trobalt uden rådgivning Du skal tage Trobalt i så lang tid, som lægen foreskriver.
English: Very common: ≥1/10 Common:
Danish: Meget almindelig: ≥ 1/10
English: For patients with end-stage renal disease receiving haemodialysis, the three daily doses should be taken as usual on the dialysis day.
Danish: Hos patienter med terminal nyreinsufficiens i hæmodialyse skal de tre daglige doser tages som sædvanligt på dialysedagen.
English: Retigabine was effective in adjunctive treatment of adults with partial onset seizures in three clinical studies (Table 1).
Danish: Retigabin var effektiv som tillægsbehandling hos voksne med partielle anfald i tre kliniske studier (tabel 1).
English: Distension of the gall bladder was seen in studies with dogs, but there was no evidence of cholestasis or other signs of gall bladder dysfunction, and bile ejection volume was unchanged.
Danish: Der blev observeret udspiling af galdeblæren i studier af hunde, men der blev ikke set kolestase eller andre tegn på dysfunktion af galdeblæren, og udstrømningsvolumenet af galde var uændret.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Danish: Der er indberettet selvmordstanker og selvmordsadfærd hos patienter, som er blevet behandlet med antiepileptika ved flere indikationer.
English: The mechanism of action of retigabine on potassium channels has been well documented, however other mechanisms by which retigabine may assert an antiepileptic effect have yet to be fully elucidated.
Danish: Mekanismen for retigabins virkning på kaliumkanaler er veldokumenteret, mens andre af retigabins mekanismer, som eventuelt kan have en antiepileptisk effekt endnu ikke er fuldt belyst.
English: In addition, retigabine and NAMR did not induce CYP1A2 or CYP3A4/5 in human primary hepatocytes.
Danish: Derudover inducerede retigabin og NAMR ikke CYP 1A2 eller CYP 3A4/5 i humane primære hepatocytter.
English: After taking a missed dose, at least 3 hours should be allowed before the next dose and then the normal dosing schedule should be resumed.
Danish: Når en oversprungen dosis er taget, skal der gå mindst 3 timer, før den næste dosis tages, og herefter skal den sædvanlige doseringsplan igen følges.
English: Each tablet contains 50 mg, 100 mg, 200 mg, 300 mg or 400 mg retigabine.
Danish: Hver tablet indeholder 50 mg, 100 mg, 200 mg, 300 mg eller 400 mg retigabin.
English: Retigabine had no effect on fertility or general reproductive performance.
Danish: Retigabin havde ingen effekt på fertiliteten eller den generelle reproduktionsevne.