FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for topiramate.
Danish: Mekanismen bag dette er ikke kendt, og tilgængelige data udelukker ikke en øget risiko ved brug af topiramat.
English: It is important that you do not stop taking your medicine without first consulting your doctor.
Danish: Det er vigtigt, at du ikke stopper med at tage din medicin uden først at tale med din læge.
English: The efficacy of topiramate in reducing seizure frequency was consistent in all 6 studies in a large number of patients participating in these studies.
Danish: Topiramats evne til at reducere anfaldenes hyppighed var ensartet i alle 6 undersøgelser hos et stort antal patienter, der deltog i disse undersøgelser.
English: • Never store any medicine and food mixture for use at a later time.
Danish: • Opbevar aldrig medicin, opblandet med mad, til senere brug.
English: This was attributed to the higher percent body fat in female patients and is of no clinical consequence.
Danish: Dette blev tilskrevet den højere procentdel af kropsfedt hos kvindelige patienter, men har ingen klinisk betydning.
English: This dose may be benefit in some patients, nevertheless, caution is advised due to an increase incidence of side effects
Danish: Denne dosis kan være en fordel hos nogle patienter, ikke desto mindre anbefales det at udvise forsigtighed på grund af den øgede forekomst af bivirkninger.
English: Each metabolite represents less than 3% of the total radioactivity excreted following administration of 14C-topiramate.
Danish: Hver metabolit repræsenterer mindre end 3% af den totalt udskilte radioaktivitet efter administration af 14C-topiramat.
English: Generally, the decrease in bicarbonate occurs early in treatment although it can occur at any time during treatment.
Danish: Normalt opstår faldet i hydrogencarbonat tidligt i behandlingen, men kan forekomme på ethvert tidspunkt under behandlingen.
English: Patients therefore should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered.
Danish: Patienter skal derfor monitoreres for tegn på selvmordstanker og suicidal opførsel og passende behandling overvejes.
English: Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated.
Danish: Doser på op til 30 mg/kg/døgn er blevet undersøgt og blev generelt godt tolereret.
English: • are on a high fat diet (ketogenic diet)
Danish: • er på en diæt med højt fedtindhold (ketogen diæt)
English: Mood disturbances/depression
Danish: Humørsvingninger/depression:
English: Make sure you are very clear about the risks and the benefits of using Topamax for epilepsy during pregnancy.
Danish: Vær sikker på, at du er helt klar over risici og fordele ved at bruge Topimax for epilepsi under graviditet.
English: About 300 patients between the age of 6 and 16 years old have been included in the clinical development of topiramate as monotherapy.
Danish: Ca. 300 patienter i alderen 6-16 år blev medtaget i den kliniske udvikling af topiramat som monoterapi.
English: • Increased thirst and drinking abnormally large amounts of fluid
Danish: • Øget tørst og tendens til at drikke unormalt store mængder væske
English: Adjunctive therapy for epilepsy in children and adults The proposed indication of adjunctive therapy is approved in all of 29 countries involved in the Article 30 procedure.
Danish: Tillægsbehandling af epilepsi hos børn og voksne Den foreslåede indikation for tillægsbehandling er godkendt i alle de 29 lande, der er involveret i artikel 30-proceduren.
English: • Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson syndrome (see uncommon side effects).
Danish: • Toksisk epidermal nekrolyse, som er en mere alvorlig form for Stevens-Johnsons syndrom (se ikke almindelige bivirkninger).
English: Consequently, the plasma concentrations of topiramate for the same mg/kg dose may be lower in children compared to adults.
Danish: Derfor kan plasmakoncentrationer af topiramat for den samme mg/kg dosis være lavere hos børn sammenlignet med voksne.
English: Your doctor will decide if you can take Topamax.
Danish: Din læge vil beslutte, om du kan tage Topimax.
English: • Feeling of movement under the skin
Danish: • Følelse af bevægelse under huden
English: Its frequency was calculated based on clinical trial data.
Danish: Frekvens er beregnet ud fra kliniske forsøgsdata.
English: Taking Topamax with food and drink
Danish: Brug af Topimax sammen med mad og drikke
English: 4.5 - Interaction with other medicinal products and other forms of interaction Data supporting the proposed text on the potential interactions of topiramate with oral contraceptives and risperidone have been presented.
Danish: 4.5 - Interaktion med andre lægemidler og andre former for interaktion Der er fremlagt data til støtte for den foreslåede tekst med hensyn til topiramats potentielle interaktioner med oral kontraception og risperidon.
English: Erectile dysfunction, sexual dysfunction
Danish: Erektil dysfunktion, seksuel dysfunktion
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Danish: Hyppigheden af bivirkninger angivet nedenfor er følgende: meget almindelig (forekommer hos mere end 1 ud af 10 brugere) almindelig (forekommer hos mellem 1 og 10 ud af 100 brugere) ikke almindelige (forekommer hos mellem 1 og 10 ud af 1.000 brugere) sjælden (forekommer hos mellem 1 og 10 ud af 10.000 brugere) meget sjælden (forekommer hos færre end 1 ud af 10.000 brugere) ikke kendt (hyppigheden kan ikke vurderes fra tilgængelige oplysninger)
English: Approximately 66% of a dose of 14C-topiramate was excreted unchanged in the urine within four days.
Danish: Ca. 66% af en dosis 14C-topiramat blev udskilt uomdannet i urinen inden for 4 dage.
English: • Problems with handwriting
Danish: • Problemer med håndskrift
English: No paediatric subjects have been investigated in any of the migraine studies and therefore no efficacy or safety claim has been made.
Danish: Ingen pædiatriske forsøgspersoner blev undersøgt i nogen af migræneundersøgelserne, og derfor er der ikke fremsat nogen virknings- eller sikkerhedspåstand.
English: This adverse reaction is not due to a pharmacokinetic interaction.
Danish: Denne bivirkning skyldes ikke en farmakokinetisk interaktion.
English: Overall, plasma clearance is approximately 20 to 30 ml/min in humans following oral administration.
Danish: Plasmaclearance er ca. 20-30 ml/min hos mennesker efter oral administration.
English: However, differences in AUC for the total active moiety between treatment with risperidone alone and combination treatment with topiramate were not statistically significant.
Danish: Forskelle i AUC for den totale mængde af aktivt stof mellem behandling med risperidon alene og kombinationsbehandling med topiramat var imidlertid ikke statistisk signifikante.
English: The justification put forward by the MAH that this shortcoming is due to the limited number of subjects and qualified study centres available was considered to be acceptable.
Danish: Den begrundelse, som indehaveren af markedsføringstilladelsen fremsatte, nemlig at denne mangel skyldes det begrænsede antal forsøgspersoner og kvalificerede undersøgelsescentre, der var til rådighed, blev anset for at være acceptabel.
English: Topamax and certain other medicines can affect each other.
Danish: Topimax og visse andre typer medicin kan påvirke hinanden.
English: There is currently no evidence that migraine prophylaxis during pregnancy reduces the risk of stroke.
Danish: Der er i øjeblikket ingen evidens for, at migræneprofylakse under graviditeten reducerer risikoen for slagtilfælde.
English: • Slow or diminished movements
Danish: • Langsomme eller mindre bevægelser
English: • Painful or burning sensations in the mouth
Danish: • Smerte- eller brændende følelse i munden
English: Where there is insufficient human data but evidence of risk from animal studies and the availability of safer alternative treatments a contraindication for the use in pregnancy is justified.
Danish: Såfremt der foreligger utilstrækkelige data om virkningen hos mennesker, men evidens for risiko fra dyreforsøg, og der eksisterer sikrere alternative behandlinger, er en kontraindikation for brugen hos gravide berettiget.
English: Do not drive or use any tools or machines without talking to your doctor first.
Danish: Du må heller ikke arbejde med værktøj eller maskiner uden at tale med lægen først.
English: Electrophysiological and biochemical studies on cultured neurons have identified three properties that may contribute to the antiepileptic efficacy of topiramate.
Danish: Elektrofysiologiske og biokemiske studier på neuronkulturer har identificeret tre egenskaber, som kan bidrage til topiramats antiepileptiske virkning.
English: Pizotifen Diltiazem25% decrease in AUC of diltiazem and 18% decrease in DEA, and ↔ for DEM*
Danish: Pizotifen Diltiazem25% fald i AUC af diltiazem og 18% fald i DEA og ↔ for DEM*
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TOPAMAX AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF TOPIMAX OG TILKNYTTEDE NAVNE (SE BILAG I)
English: The fact that this effect was reproducible and has been observed in three species, both rodent and non-rodent is suggestive of a potential risk to humans.
Danish: Den kendsgerning, at denne virkning var reproducerbar og er blevet observeret hos tre arter, både hos gnavere og andre arter, tyder på en potentiel risiko for mennesker.
English: The MAH has supplied the analysis of data by age group for each study.
Danish: Indehaveren af markedsføringstilladelsen har leveret en analyse af data pr. aldersgruppe for hver undersøgelse.
English: • Low blood pressure or decrease in blood pressure that occurs when you stand up
Danish: • Lavt blodtryk eller blodtryksfald, når man rejser sig op
English: As part of the initial application, the MAH submitted a full non-clinical package in support of product registration including a complete package of reproductive toxicology reports.
Danish: Som led i den indledende ansøgning indsendte indehaveren af markedsføringstilladelsen en fuldstændig ikkeklinisk pakke til støtte for lægemiddelregistreringen, herunder en komplet pakke af reproduktionstoksikologirapporter.
English: Increase in exposure may be attributed to accumulation during achievement of steady state.
Danish: Stigning i eksponering kan skyldes akkumulering under opnåelse af steady-state.
English: Rarely, patients have experienced decreases to values below 10 mmol/l.
Danish: I sjældne tilfælde er set fald til værdier under 10 mmol/l.
English: The film-coated tablet and hard capsule formulations are bioequivalent.
Danish: Den filmcoatede tablet og den hårde kapsel er bioækvivalente.
English: Patients with normal renal function may take 4 to 8 days to reach steady-state plasma concentrations.
Danish: Det kan tage patienter med normal nyrefunktion 4-8 dage at nå steady-state plasmakoncentrationer.
English: The clinical development in general fulfils the CHMP Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Epileptic Disorders, with respect to the key issues.
Danish: Den kliniske udvikling opfylder generelt CHMP's "Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Epileptic Disorders", hvad nøgleområderne angår.
English: Anorexia, decreased appetite
Danish: Anorexi, nedsat appetit
English: No evidence of tolerance has been demonstrated in man.
Danish: Der er ikke påvist tendens til toleranceudvikling hos mennesker.
English: Hydration can reduce the risk of nephrolithiasis (see below).
Danish: Dette kan reducere risikoen for nefrolithiasis (se nedenfor).
English: This indication is endorsed by the current recommendations of the European Federation of Neurological Societies (EFNS) task force (2006) where topiramate is considered an appropriate first-line prophylactic migraine medication based on scientific evidence from clinical trials and on expert consensus of the EFNS.
Danish: Denne indikation godkendes i de nuværende anbefalinger fra European Federation of Neurological Societies' (EFNS) arbejdsgruppe (2006), hvor topiramat anses for at være et hensigtsmæssigt førstevalgs migræneforebyggende lægemiddel baseret på videnskabelig evidens fra kliniske undersøgelser og på EFNS's ekspertkonsensus.
English: • Crystals in the urine
Danish: • Krystaller i urinen
English: Like all medicines, Topamax can cause side effects, although not everybody gets them.
Danish: Topimax kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The proposed SPC wording reflects the non-significant difference in concentration seen and appropriately concludes that the interaction is unlikely to be of clinical significance.
Danish: Den foreslåede ordlyd i produktresuméet afspejler den observerede ikkesignifikante forskel i koncentrationen, og det konkluderes helt korrekt, at det er usandsynligt, at interaktion er af klinisk relevans.
English: Key secondary outcomes (responder rate, migraine attack rate, use of rescue medication) demonstrated a consistent response.
Danish: Vigtige sekundære resultater (responsrate, migræneanfaldshyppighed, brug af redningsmedicin) viste en entydig respons.
English: • for migraine prevention if you are pregnant or you are able to become pregnant but you are not using effective contraception (see section ‘pregnancy and breastfeeding' for further information).
Danish: • til forebyggelse af migræne hvis du er gravid, eller du er i den fødedygtige alder og ikke bruger effektiv svangerskabsforebyggelse (se sektionen ”Graviditet og amning” for yderligere information).
English: These effects of topiramate were concentrationdependent over a range of 1 µM to 200 µM, with minimum activity observed at 1 µM to 10 µM.
Danish: Disse virkninger af topiramat var koncentrationsafhængige i et område fra 1 μM til 200 μM, med observeret minimumsaktivitet fra 1 μM til 10 μM.
English: “Adults
Danish: “Voksne
English: These phenomena may be the consequence of an overdose, a decrease in plasma concentrations of concomitantly used anti-epileptics, progress of the disease, or a paradoxical effect.
Danish: Disse fænomener kan være en konsekvens af overdosis, nedsat plasmakoncentration af andre antiepileptika brugt samtidig, progression af sygdommen eller en paradokseffekt.
English: The MAH provided a review of data collections from J&J PRD's own pharmacovigilance database and prospective pregnancy registries, which identified potential risks to the foetus of pregnant women treated with topiramate.
Danish: Indehaveren af markedsføringstilladelsen fremlagde en gennemgang af dataindsamlinger fra J&J PRD's egen lægemiddelovervågningsdatabase og prospektive graviditetsregistre, som identificerede potentielle risici for fosteret hos gravide kvinder, der behandles med topiramat.
English: Overdose can happen if you are taking other medicines together with Topamax.
Danish: Overdosering kan ske, hvis du tager anden medicin sammen med Topimax.
English: In addition the CHMP supported the deletion of any mention of the interchangeability of different products of topiramate in individual patients, in the product information.
Danish: Desuden støttede CHMP fjernelsen af enhver henvisning til forskellige topiramatprodukters substituerbarhed hos enkelte patienter i produktinformationen.
English: Topiramate is not extensively metabolized (~20%) in healthy volunteers.
Danish: Topiramat metaboliseres ikke i udstrakt grad (~20%) hos raske forsøgspersoner.
English: Based on the recovery of radioactivity from the urine the mean extent of absorption of a 100 mg oral dose of 14C-topiramate was at least 81%.
Danish: Baseret på måling af radioaktivitet i urinen var den gennemsnitlige absorption af en 100 mg oral dosis af 14C-topiramat mindst 81%.
English: Note: This SPC, labelling and package leaflet is the version valid at the time of Commission Decision.
Danish: Bemærk: Dette SPC, etikettering og indlægsseddel er gyldige på tidspunktet for Kommisionsbeslutningen.
English: Topiramate is not intended for acute treatment.”
Danish: Topiramat er ikke beregnet på akut behandling.”
English: Topiramate inhibits the enzyme CYP 2C19 and may interfere with other substances metabolized via this enzyme (e.g., diazepam, imipramin, moclobemide, proguanil, omeprazol).
Danish: Topiramat inhiberer enzymet CYP 2C19 og kan interferere med andre stoffer, der bliver metaboliseret via dette enzym (f.eks. diazepam, imipramin, moclobemid, proguanil, omeprazol).
English: Because the antiepileptic profile of topiramate differs markedly from that of the benzodiazepines, it may modulate a benzodiazepine-insensitive subtype of GABAA receptor.
Danish: Da topiramats antiepileptiske profil er markant forskellig fra benzodiazepinernes, kan det modulere en benzodiazepin-insensitiv undergruppe af GABAA-receptorer.
English: Toxic epidermal necrolysis*
Danish: Toksisk epidermal nekrolyse*
English: In humans, the major route of elimination of unchanged topiramate and its metabolites is via the kidney (at least 81% of the dose).
Danish: Hos mennesker er eliminationsvejen overvejende udskillelse af uomdannet topiramat og dets metabolitter via nyrerne (mindst 81% af dosis).
English: Activated charcoal has been shown to adsorb topiramate in vitro.
Danish: Aktivt kul er vist at adsorbere topiramat in vitro.
English: • Maculopathy is a disease of the macula, the small spot in the retina where vision is keenest.
Danish: • Maculopati, en sygdom i maculaen, der er den lille plet på nethinden, hvor synet er størst.
English: Janssen-Cilag Kft. - HU 2045 Törökbálint Tó park, Hungary
Danish: Janssen-Cilag Kft. - HU 2045 Törökbálint Tó park, Ungarn
English: During pregnancy, topiramate should be prescribed after fully informing the woman of the known risks of uncontrolled epilepsy to the pregnancy and the potential risks of the medicinal product to the foetus.
Danish: Under graviditet bør topiramat kun ordineres, efter kvinden er blevet fuldt informeret om den kendte risiko, ukontrolleret epilepsi udgør for graviditeten, og den potentielle risiko, lægemidlet udgør for fosteret.
English: There were no significant changes in the systemic exposure of the risperidone total active moiety or of topiramate.
Danish: Der var ingen signifikante ændringer i den systemiske eksponering af den totale aktive substans af risperidon eller af topiramat.
English: Similarly, the link between migraine and ischaemic stroke is not proven.
Danish: Forbindelsen mellem migræne og iskæmisk slagtilfælde er heller ikke bevist.
English: Mydriasis may or may not be present.
Danish: Mydriasis kan være til stede, men er det ikke i alle tilfælde.
English: This pharmacologic effect is much weaker than that of acetazolamide, a known carbonic anhydrase inhibitor, and is not thought to be a major component of topiramate's antiepileptic activity.
Danish: Denne farmakologiske effekt er meget svagere end acetazolamids, en kendt carbonanhydrasehæmmer, og anses ikke for at være en vigtig komponent i topiramats antiepileptiske aktivitet.
English: Talk to your doctor before using Topamax if you are pregnant, trying to become pregnant or breast-feeding.
Danish: Tal med din læge, før du tager Topimax, hvis du er gravid, prøver at blive gravid eller ammer.
English: The proposed wording in this section is considered to be acceptable by the CHMP.
Danish: CHMP betragter den foreslåede ordlyd i dette punkt som acceptabel.
English: The excretion of topiramate in human milk has not been evaluated in controlled studies.
Danish: Udskillelsen af topiramat i human modermælk er ikke evalueret i kontrollerede undersøgelser.
English: Treatment includes discontinuation of topiramate, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure.
Danish: Behandling indbefatter seponering af topiramat så hurtigt som muligt efter den behandlende læges vurdering og tiltag for at reducere det intraokulære tryk.
English: The changes in Cmax or AUC as a result of the interactions are summarized below.
Danish: Ændringerne i Cmax eller AUC er sammenfattet i tabellen nedenfor.
English: The harmonisation of topiramate marketed in the EU Member States, Norway and Iceland applies to two formulations: - tablets (25 mg, 50 mg, 100 mg, 200 mg) - capsules (15 mg, 25 mg, 50 mg)
Danish: Harmoniseringen af topiramat, som markedsføres i EU's medlemsstater, Norge og Island, gælder for to formuleringer: - tabletter (25 mg, 50 mg, 100 mg, 200 mg) - kapsler (15 mg, 25 mg, 50 mg)
English: Topiramate was teratogenic in mice, rats and rabbits.
Danish: Topiramat er vist at være teratogent i mus, rotter og kaniner.
English: • Decreased verbal communication
Danish: • Nedsat mundtlig kommunikation
English: The embryofetal studies show clear evidence of the teratogenic potential of topiramate.
Danish: De embryoføtale undersøgelser viser tydelig evidens for topiramats teratogene potentiale.
English: Neutropenia*
Danish: Neutropeni*
English: The MAH justifies this difference stating that the imbalance in baseline seizure rate, in seizure severity and selective discontinuation rate among the groups could have contributed to the underestimation of topiramate efficacy.
Danish: Indehaveren af markedsføringstilladelsen begrunder denne forskel med, at ubalancen i baselineanfaldshyppigheden og i anfaldenes sværhedsgrad samt den selektive seponeringsrate blandt grupperne kan have bidraget til undervurderingen af topiramats virkning.
English: Therefore the following harmonised indication for the treatment of seizures associated with Lennox-Gastaut syndrome was adopted by the CHMP.
Danish: Derfor blev følgende harmoniserede indikation for behandlingen af anfald i forbindelse med LennoxGastauts syndrom godkendt af CHMP.
English: You may loss weight if you use Topamax so your weight should be checked regularly when using this medicine.
Danish: Du kan muligvis tabe dig, når du tager Topimax, så din vægt skal kontrolleres regelmæssigt, så længe du får medicinen.
English: Given that an increase in the number of adverse events (as well as the AEs leading to study discontinuation) is observed when risperidone and topiramate are administered concomitantly, the wording of this subsection has been slightly amended.
Danish: Eftersom der observeres et øget antal bivirkninger (såvel som de bivirkninger, der fører til undersøgelsens afbrydelse), når risperidon og topiramat indgives samtidig, er ordlyden i dette underpunkt blevet ændret en smule.
English: • Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: In addition, data from these registries and other studies suggest that, compared with monotherapy, there may be an increased risk of teratogenic effects associated with the use of anti-epileptic drugs in combination therapy.
Danish: Data fra disse registre og data fra andre forsøg antyder også, at sammenlignet med monoterapi er der en øget risiko for teratogen effekt ved brug af antiepileptika i kombinationsterapi.
English: It is recommended that filmcoated tablets not be broken.
Danish: Det anbefales ikke at dele filmovertrukne tabletter.
English: Although a literature review presented by the MAH indicates that there is a potential benefit in using migraine prophylactic treatment in pregnant women suffering from migraine, it is fair to say that the vast majority of migraine improves during pregnancy, although the exact figures from studies vary.
Danish: Selv om en litteraturgennemgang, som indehaveren af markedsføringstilladelsen har fremlagt, indikerer, at der er en potentiel fordel ved at bruge migræneprofylaksebehandling hos gravide kvinder, der lider af migræne, skal det retfærdigvis siges, at langt de fleste migrænetilfælde forbedres under graviditeten, selv om de nøjagtige tal fra undersøgelserne varierer.