FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP is of the view that the contraindication for the use of topiramate for the indication of migraine prophylaxis during pregnancy and in women of child bearing potential without adequate contraception is justified based on the demonstration of teratogenicity of topiramate in three animal species and the availability of alternative acute and prophylactic treatments for migraine during pregnancy that have not been shown to be teratogenic in three animal species.
Danish: CHMP er af den opfattelse, at kontraindikationen for brugen af topiramat til indikationen migræneprofylakse hos gravide og fertile kvinder uden passende kontraception er berettiget, eftersom topiramats teratogenicitet er påvist hos tre dyrearter, og eftersom der eksisterer alternative akutte behandlinger og profylaksebehandlinger af migræne under graviditeten, som ikke har vist sig at være teratogene hos tre dyrearter.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Topiramate is a sulfamate-substituted monosaccharide.
Danish: Topiramat er et sulfamatsubstitueret monosaccharid.
English: In those women who require prophylactic treatment for migraine, an agent not shown to be teratogenic in three animal species at low dose, is preferred.
Danish: Hos de kvinder, der kræver profylaksebehandling ved migræne, foretrækkes et stof, som ved lave doser har vist sig ikke at være teratogent hos tre dyrearter.
English: The MAH disagreed with this proposal stating that in all trials, patients were not required to have failed on prophylactic migraine medications.
Danish: Indehaveren af markedsføringstilladelsen var uenig i dette forslag og anførte, at det i alle undersøgelserne ikke forlangtes af patienterne, at de ikke havde responderet på migræneforebyggende lægemidler.
English: Some patients, especially those with a predisposition to nephrolithiasis, may be at increased risk for renal stone formation and associated signs and symptoms such as renal colic, renal pain or flank pain.
Danish: Nogle patienter, specielt de der er prædisponerede for nefrolithiasis, kan have en øget risiko for nyrestensdannelse og associerede symptomer som nyrekolik, nyresmerter eller flankesmerter.
English: While using Topamax, agents like these should be avoided since they may create a physiological environment that increases the risk of renal stone formation.
Danish: Under behandling med Topimax bør lægemidler som disse undgås, da de kan danne et fysiologisk miljø, der øger risikoen for dannelse af nyresten.
English: Topiramate overdose can result in severe metabolic acidosis (see section 4.4).
Danish: Overdosering med topiramat kan medføre alvorlig metabolisk acidose (se pkt.
English: An effective dose range of 200-400mg/day for adults was endorsed by the CHMP.
Danish: Et effektivt dosisinterval på 200-400 mg om dagen til voksne blev godkendt af CHMP.
English: The most frequently reported AE's when topiramate was added to risperidone treatment were: somnolence (27% and 12%), paraesthesia (22% and 0%) and nausea (18% and 9% respectively).
Danish: De hyppigst rapporterede bivirkninger, når topiramat blev føjet til risperidon behandling, var: døsighed (27% og 12%), paræstesier (22% og 0%) og kvalme (18% og 9% respektivt).
English: Action potentials elicited repetitively by a sustained depolarization of the neurons were blocked by topiramate in a time-dependent manner, suggestive of a state-dependent sodium channel blocking action.
Danish: Aktionspotentialer, som er fremkaldt af vedvarende depolarisering af neuroner, blokeres af topiramat på en tidsafhængig måde, hvilket indikerer en tilstandsafhængig blokade af natriumkanaler.
English: The hard capsule formulation is provided for those patients who cannot swallow tablets, e.g. paediatric and the elderly.
Danish: Den hårde kapsel er fremstillet til patienter, der ikke kan synke hele tabletter, fx børn og ældre.
English: Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhoea, surgery, ketogenic diet, or certain medicinal products) may be additive to the bicarbonate lowering effects of topiramate.
Danish: Tilstande eller behandlinger, der disponerer for acidose (som nyresygdom, alvorlige respiratoriske tilstande, status epilepticus, diaré, operation, ketogen diæt eller visse lægemidler) kan virke additivt til topiramats nedsættelse af hydrogencarbonatkoncentrationen.
English: Other medicinal product interactions
Danish: Interaktioner med andre lægemidler
English: • Increased acid levels in the blood
Danish: • Øget syreindhold i blodet
English: Topiramate should be used with caution in patients with conditions or treatments that represent a risk factor for the appearance of metabolic acidosis.
Danish: Topiramat skal gives med forsigtighed til patienter med tilstande eller behandlinger, der repræsenterer en risikofaktor for metabolisk acidose.
English: In rats, topiramate crosses the placental barrier.
Danish: I rotter passerer topiramat placentabarrieren.
English: These adverse reactions could potentially be dangerous in patients driving a vehicle or operating machinery, particularly until such time as the individual patient's experience with the medicinal products established.
Danish: Disse bivirkninger kan potentielt medføre farlige situationer for patienter i trafikken eller under arbejde med maskiner, specielt indtil patienterne er bekendt med, hvordan lægemidlet virker på dem.
English: Although not achieving statistical significance in a given age group 2-5 yrs, 6-9 yrs, 10-15 yrs and ≥16 yrs, the general trend is toward numerical superiority to placebo in each age group.
Danish: Selv om der ikke opnås statistisk signifikans i en given aldersgruppe (2-5 år, 6-9 år, 10-15 år og ≥16 år), er den generelle tendens, at tallet for topiramat overstiger tallet for placebo i hver aldersgruppe.
English: It is not necessary to monitor topiramate plasma concentrations to optimize therapy with Topamax.
Danish: Det er ikke nødvendigt at monitorere plasmakoncentrationen af topiramat for at optimere behandlingen med Topimax.
English: As with other anti-epileptic drugs, some patients may experience an increase in seizure frequency or the onset of new types of seizures with topiramate.
Danish: Som for andre antiepileptika kan nogle patienter opleve en øget anfaldsfrekvens eller start af nye typer af anfald ved brug af topiramat.
English: The pharmacokinetic profile of topiramate compared to other antiepileptic drugs shows a long plasma halflife, linear pharmacokinetics, predominantly renal clearance, absence of significant protein binding, and lack of clinically relevant active metabolites.
Danish: Sammenligning af topiramats farmakokinetiske profil med andre antiepileptika viser en lang plasmahalveringstid, lineær farmakokinektik, overvejende renal clearance, ubetydelig proteinbinding samt fravær af klinisk relevante aktive metabolitter.
English: The evidence of the efficacy and safety of topiramate as monotherapy in the treatment of epilepsy has been presented from 4 randomised controlled studies.
Danish: Evidensen for topiramats virkning og sikkerhed som monoterapi ved behandling af epilepsi bygger på 4 randomiserede, kontrollerede undersøgelser.
English: However, if it is almost time for your next dose, skip the missed dose and continue as usual.
Danish: Hvis du snart skal tage den næste dosis, så spring den glemte dosis over og fortsæt blot med den sædvanlige dosis.
English: In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended (see section 4.2 for further details).
Danish: I situationer, hvor topiramat af medicinske grunde skal seponeres hurtigt, anbefales passende monitorering (se pkt.
English: • to prevent migraine headaches in adults
Danish: • til at forebygge migræneanfald hos voksne.
English: Studies in mice receiving concomitant administration of topiramate and carbamazepine or phenobarbital showed synergistic anticonvulsant activity, while combination with phenytoin showed additive anticonvulsant activity.
Danish: Studier med mus ved samtidig administration af topiramat og carbamazepin eller phenobarbital viste synergistisk antikonvulsiv aktivitet, hvorimod kombination med phenytoin viste additiv antikonvulsiv aktivitet.
English: Bradycardia, sinus bradycardia, palpitations
Danish: Bradykardi, sinusbradykardi, palpitationer
English: A low capacity binding site for topiramate in/on erythrocytes that is saturable above plasma concentrations of 4 µg/ml has been observed.
Danish: Der er blevet observeret en lav bindingskapacitet af topiramat i/på erytrocytter, som er mættet ved plasmakoncentrationer over 4 μg/ml.
English: Topiramate acts on the central nervous system and may produce drowsiness, dizziness or other related symptoms.
Danish: Topiramat virker på centralnervesystemet og kan medføre sløvhed, svimmelhed eller andre tilsvarende symptomer.
English: ADRs identified in clinical trials, and during post-marketing experience (as indicated by “*”) are listed by their incidence in clinical trials in Table 1.
Danish: Bivirkninger, der er set i kliniske forsøg og efter markedsføringen (indikeret med *) er i tabel 1 listet efter hyppighed i de kliniske forsøg.
English: Partial onset seizures (POS) with or without secondary generalization in Adults and Children The results of 6 controlled studies indicate that adjunctive therapy in adults with topiramate has significant therapeutic benefit in controlling partial onset seizures with or without secondary generalisation.
Danish: Partielle anfald med eller uden sekundær generalisering hos voksne og børn Resultaterne af 6 kontrollerede undersøgelser viser, at tillægsbehandling med topiramat hos voksne har betydelige terapeutiske fordele, når det gælder kontrollen af partielle anfald med eller uden sekundær generalisering.
English: Other medicines you should discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine
Danish: Andre lægemidler, som du bør tale med din læge eller apoteket om, er anden antiepileptisk medicin, risperidon, lithium, hydrochlorthiazid, metformin, pioglitazon, glibenclamid, amitriptylin, propranolol, diltiazem, venlafaxin og flunarizin.
English: Adequate hydration while using topiramate is very important.
Danish: Tilstrækkelig hydrering er meget vigtig ved topiramatbehandling.
English: Topamax (topiramate) is not recommended for treatment or prevention of migraine in children due to insufficient data on safety and efficacy.
Danish: Topimax (topiramat) bør ikke anvendes til forebyggelse af migræne hos børn pga. manglende dukumentation for sikkerhed og virkning.
English: The addition of Topamax to other antiepileptic drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, primidone) has no effect on their steady-state plasma concentrations, except in the occasional patient, where the addition of Topamax to phenytoin may result in an increase of plasma concentrations of phenytoin.
Danish: Tillæg af Topimax til andre antiepileptika (phenytoin, carbamazepin, valproat, phenobarbital, primidon) har ingen effekt på steady-state plasmakoncentrationer af disse undtagen i særlige tilfælde, hvor tillæg af Topimax til phenytoin kan resultere i en øget plasmakoncentration af phenytoin.
English: Here, the seizure types studies included both partial onset seizures (defined as partial, complex partial, or partial evolving into secondarily generalized seizures) and generalized seizures (defined as generalized tonic-clonic, tonic, or clonic seizures).
Danish: Her omfattede anfaldstypeundersøgelserne både partielle anfald (defineret som simple partielle anfald, komplekse partielle anfald eller partielle anfald med sekundær generalisering) og generaliserede anfald (defineret som generaliserede tonisk-kloniske anfald, toniske anfald eller kloniske anfald).
English: If your doctor decides to stop this medication, your dose may be decreased gradually over a few days.
Danish: Hvis lægen beslutter at stoppe behandlingen, vil lægen gradvist nedsætte din dosis i løbet af et par dage for at nedsætte risikoen for, at du får kramper.
English: The results of this study indicate that topiramate Cmax increased by 27% and AUC increased by 29% when HCTZ was added to topiramate.
Danish: Cmax for topiramat steg med 27%, og AUC steg med 29%, når hydrochlorthiazid blev givet i tillæg til topiramat.
English: You should avoid drinking alcohol when taking Topamax.
Danish: Du bør ikke drikke alkohol, så længe du tager Topimax.
English: Concomitant multiple-dose administration of topiramate, 100 to 400 mg twice a day, with phenytoin or carbamazepine shows dose proportional increases in plasma concentrations of topiramate.
Danish: Samtidig administration af topiramat, 100-400 mg 2 gange daglig med phenytoin eller carbamazepin viser dosisproportionale stigninger i plasmakoncentrationen af topiramat.
English: Always take Topamax exactly as your doctor has told you.
Danish: Tag altid Topimax nøjagtigt efter lægens anvisning.
English: As a result, higher steady-state topiramate plasma concentrations are expected for a given dose in renal-impaired patients as compared to those with normal renal function.
Danish: Derfor forventes højere steady-state plasmakoncentrationer af topiramat for en given dosis til patienter med nedsat nyrefunktion sammenlignet med patienter med normal nyrefunktion.
English: Paediatric population (pharmacokinetics, up to 12 years of age)
Danish: Pædiatrisk farmakokinetik op til 12-årsalderen:
English: It is recommended that women of child bearing potential use adequate contraception.
Danish: Kvinder i den fødedygtige alder bør anvende egnet kontraception.
English: Treatment of children over 6 years of age should begin at 0.5 to 1 mg/kg nightly for the first week.
Danish: Behandling af børn over 6 år bør initieres med 0,5-1 mg/kg til natten i en uge.
English: • Decrease or loss of appetite
Danish: • Nedsat eller mistet appetit
English: The clinical significance of the changes observed is not known.
Danish: Den kliniske betydning af de observerede ændringer er ikke kendt.
English: The evidence of the efficacy of topiramate as adjunctive therapy for partial onset seizures with or without secondarily generalised seizures in paediatric patients has been derived from a multicentre, placebocontrolled study (YP).
Danish: Evidensen for topiramats virkning som tillægsbehandling ved partielle anfald med eller uden sekundær generalisering hos pædiatriske patienter stammer fra en placebokontrolleret multicenterundersøgelse (YP).
English: This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma.
Danish: Dette syndrom kan være associeret med supraciliær effusion, og kan resultere i anterior forskydning af linsen og iris med sekundært snævervinklet glaukom.
English: Drink plenty of fluids during the day to prevent kidney stones while taking Topamax.
Danish: Drik rigeligt med væske i løbet af dagen for at undgå nyresten, mens du tager Topimax.
English: In well-controlled add-on trials, no correlation has been demonstrated between trough plasma concentrations of topiramate and its clinical efficacy.
Danish: I velkontrollerede add-on forsøg blev der ikke påvist korrelation mellem trough plasmakoncentrationer af topiramat og dets kliniske effekt.
English: Concomitant administration of Topamax and alcohol or other CNS depressant medicinal products has not been evaluated in clinical studies.
Danish: Samtidig indtagelse af Topimax og alkohol eller andre CNS-supprimerende lægemidler er ikke blevet evalueret i kliniske undersøgelser.
English: Paediatric population (children over 6 years of age)
Danish: Børn (over 6 år)
English: Patients have received a total daily dose up to 200 mg/day.
Danish: Patienter har fået en total daglig dosis på op til 200 mg.
English: Janssen-Cilag S.A. - ES Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain
Danish: Janssen-Cilag S.A. - ES Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanien
English: 20 film-coated tablets with desiccant 28 film-coated tablets with desiccant 50 film-coated tablets with desiccant 56 film-coated tablets with desiccant 60 film-coated tablets with desiccant 100 film-coated tablets with desiccant
Danish: 20 filmovertrukne tabletter med tørremiddel 28 filmovertrukne tabletter med tørremiddel 50 filmovertrukne tabletter med tørremiddel 56 filmovertrukne tabletter med tørremiddel 60 filmovertrukne tabletter med tørremiddel 100 filmovertrukne tabletter med tørremiddel
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.
Danish: Selvmordstanker og suicidal opførsel er rapporteret i flere tilfælde hos patienter, der var i behandling med antiepileptisk medicin.
English: The investigation of topiramate as monotherapy in the paediatric population related to a minority (~20%) of the patients evaluated in the randomized controlled studies of topiramate monotherapy who were children (≤16 years of age).
Danish: Undersøgelsen af topiramat som monoterapi hos den pædiatriske population vedrørte et mindretal (~20 %), som var børn (≤16 år), ud af de patienter, der blev evalueret i de randomiserede, kontrollerede undersøgelser af topiramat som monoterapi.
English: A number of areas of disharmony in the product information for topirmate have been evaluated by the CHMP and the revised Product Information (PI) was adopted.
Danish: CHMP har vurderet en række områder, hvor der fandtes uoverensstemmelser i produktinformationen for topiramat, og en revideret produktinformation blev vedtaget.
English: Indication Epilepsy
Danish: Indikation epilepsi
English: The maximum weekly incremental dose titration has been amended to 50mg/day, as opposed to the 100mg/day.
Danish: Den maksimale ugentlige stigende dosistitrering blev ændret til 50 mg om dagen i stedet for 100 mg om dagen.
English: ≥1/100 to <1/10
Danish: ≥1/100 til <1/10
English: Limited observations in patients suggest an extensive excretion of topiramate into breast milk.
Danish: Begrænsede data fra patienter tyder på, at der er en ekstensiv udskillelse af topiramat i modermælk.
English: These dosing recommendations apply to all adults including the elderly in the absence of underlying renal disease.
Danish: Disse doseringsanbefalinger gælder for alle voksne, inklusive ældre uden nyresygdomme.
English: Seizures associated with Lennox-Gastaut syndrome (LGS) The use of topiramate as add-on therapy in patients (adults and paediatrics) with LGS treated with up to 2 AEDs was supported by only one, controlled, rather short study.
Danish: Anfald i forbindelse med Lennox-Gastauts syndrom (LGS) Brugen af topiramat som tillægsbehandling hos (voksne og pædiatriske) patienter med LGS, der behandles med op til to AED'er, blev udelukkende underbygget af én kontrolleret og relativt kort undersøgelse.
English: Some patients may experience weight loss whilst on treatment with topiramate.
Danish: Nogle patienter kan opleve vægttab, mens de er i behandling med topiramat.
English: Topamax can be taken without regard to meals.
Danish: Topimax kan tages uafhængigt af måltider.
English: A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate.
Danish: Et symptom bestående af akut myopi associeret med sekundært nævervinklet glaukom er blevet rapporteret hos patienter i behandling med topiramat.
English: • Tissue calcification (calcinosis).
Danish: • Aflejring af kalk i vævene (calcinosis)
English: There have been no new toxicology data produced by the MAH in support of topiramate, other than an oral toxicity study in juvenile rats.
Danish: Indehaveren af markedsføringstilladelsen har ikke fremlagt nogen nye toksikologidata til støtte for topiramat bortset fra en undersøgelse af oral toksicitet hos unge rotter.
English: Effects on growth were also indicated by lower weights at birth and during lactation for pups from female rats treated with 20 or 100 mg/kg/day during gestation and lactation.
Danish: Effekt på væksten blev også indikeret ved lavere fødselsvægt og under amningen af afkom fra hunrotter behandlet med 20 eller 100 mg/kg/døgn under drægtighed og amning.
English: The mean apparent volume of distribution was 0.80 to 0.55 l/kg for a single dose range of 100 to 1200 mg. An effect of gender on the volume of distribution was detected, with values for females circa 50% of those for males.
Danish: Det tilsyneladende fordelingsvolumen var gennemsnitligt 0,80-0,55 l/kg for en enkeltdosis mellem 100-1.200 mg. Fordelingsvolumenet er afhængigt af kønnet, idet værdier for kvinder er ca. 50 % af mændenes.
English: If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topamax.
Danish: Hvis du ikke er sikker på om ovenstående gælder for dig, så tal med din læge eller apoteket, før du bruger Topimax.
English: You should not take Topamax for migraine prevention if you are pregnant or you are able to become pregnant and you are not using effective contraception.
Danish: Du må ikke tage Topimax til forebyggelse af migræne, hvis du er gravid, eller du er i den fødedygtige alder og ikke bruger effektiv svangerskabsforebyggelse.
English: The suggested dose titration of 25mg/day for one week with 25mg weekly increments was endorsed by the CHMP.
Danish: Den foreslåede dosistitrering på 25 mg om dagen i en uge med en forøgelse på 25 mg om ugen blev godkendt af CHMP.
English: Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria.
Danish: Risikofaktorer for nefrolithiasis omfatter tidligere stendannelse, en familieanamnese med nefrolithiasis og hyperkalciuri.
English: In most cases, symptoms and signs abated with discontinuation of either medicinal product.
Danish: I de fleste tilfælde er symptomerne aftaget ved seponering af et af lægemidlerne.
English: In addition, topiramate inhibits some isoenzymes of carbonic anhydrase.
Danish: Derudover hæmmer topiramat nogle isoenzymer af carbonanhydrase.
English: The clinical relevance of this observation has not been established.
Danish: Den kliniske relevans af denne observation er ikke klarlagt.
English: The effect of topiramate on bonerelated sequelae has not been systematically investigated in paediatric or adult populations.
Danish: Effekten af topiramat på knoglerelaterede følgesygdomme er ikke systematisk undersøgt hos børn eller voksne.
English: There was a 25% reduction in glyburide AUC24 during topiramate administration.
Danish: Der sås en 25% reduktion i glibenclamid AUC24 ved samtidig indgift af topiramat.
English: When topiramate was added to existing risperidone (1-6 mg/day) treatment, adverse events were reported more frequently than prior to topiramate (250-400 mg/day) introduction (90% and 54 % respectively).
Danish: Når topiramat blev tilføjet til eksisterende risperidonbehandling (1-6 mg/døgn), blev bivirkninger rapporteret hyppigere end før tillæg af topiramat (250-400 mg/døgn) (henholdsvis 90% and 54%).
English: Topiramate antagonized the ability of kainate to activate the kainate/AMPA (α -amino-3-hydroxy-5-methylisoxazole-4-propionic acid) subtype of excitatory amino acid (glutamate) receptor, but had no apparent effect on the activity of N-methyl-Daspartate (NMDA) at the NMDA receptor subtype.
Danish: Topiramat antagoniserede kainats evne til at aktivere kainat/AMPA (α-amino-3-hydroxy-5-methylisoxazol-4-propionsyre) subgruppen af excitatorisk aminosyre (glutamat)-receptoren, men havde tilsyneladende ingen effekt på aktiviteten af N-methyl-D-aspartat (NMDA) på NMDA-receptor.subgruppen.
English: Effects of other antiepileptic medicinal products on Topamax
Danish: Effekt af andre antiepileptika på Topimax
English: • if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topamax (listed in section 6).
Danish: • hvis du er overfølsom (allergisk) over for topiramat eller et af de øvrige indholdsstoffer (se pkt.