FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 70.4% of paediatric subjects who received ZNS in the controlled study or its open label extension had at least one treatment-emergent bicarbonate measurement below 22 mmol/L.
Danish: I alt 70,4 % af de pædiatriske patienter, som fik zonisamid i det kontrollerede studie eller dets åbne forlængelse, havde mindst én hydrogencarbonatmåling under 22 mmol/l, som opstod under behandlingen.
English: • liver problems, kidney failure, increased blood levels of creatinine (a waste product that your kidneys should normally remove).
Danish: • leverproblemer, nyresvigt, øget indhold af kreatinin i blodet (et affaldsprodukt, som nyrerne normalt burde fjerne).
English: Date of first authorisation: 10/03/2005 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: Dato for seneste fornyelse:
English: The safety and efficacy of Zonegran in children aged below 6 years or those below 20 kg have not yet been established.
Danish: Zonegrans sikkerhed og virkning hos børn under 6 år eller under 20 kg er endnu ikke klarlagt.
English: Prescribers should also take account of the safety profile of Zonegran (see section 4.8).
Danish: De ordinerende læger bør også tage hensyn til Zonegrans sikkerhedsprofil (se pkt.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om Zonegran, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: • The recommended daily dose is between 300 mg and 500 mg.
Danish: • Den anbefalede daglige dosis er på mellem 300 mg og 500 mg.
English: In adults, efficacy has been demonstrated with Zonegran in 4 double-blind, placebo-controlled studies of periods of up to 24 weeks with either once or twice daily dosing.
Danish: Hos voksne er effekten af Zonegran blevet påvist i 4 dobbeltblindede, placebo-kontrollerede studier i perioder på op til 24 uger med dosering enten én eller 2 gange dagligt.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.
Danish: Der er blevet rapporteret om selvmordstanker og -adfærd hos patienter, der er blevet behandlet med antiepileptika for forskellige indikationer.
English: Patients with an impaired liver function: The pharmacokinetics of zonisamide in patients with impaired liver function have not been adequately studied.
Danish: Patienter med nedsat leverfunktion: Zonisamids farmakokinetik hos patienter med nedsat leverfunktion er ikke undersøgt tilstrækkeligt.
English: Do not breast-feed whilst taking, or for one month after stopping Zonegran.
Danish: De må ikke amme, mens De tager, eller i en måned efter, De er holdt op med Zonegran.
English: The increase at steady state was slightly more than expected on the basis of dose, probably due to the saturable binding of zonisamide to erythrocytes.
Danish: Stigningen ved steady-state var en smule større end forventet på basis af doseringen, sandsynligvis på grund af bindingen af zonisamid til erytrocytterne, en binding med mætningskinetik.
English: The mechanism of action of zonisamide is not fully elucidated, but it appears to act on voltage-sensitive sodium and calcium channels, thereby disrupting synchronised neuronal firing, reducing the spread of seizure discharges and disrupting subsequent epileptic activity.
Danish: Zonisamids virkningsmekanisme er ikke fuldt ud klarlagt, men det synes at virke på spændingsfølsomme natrium- og calciumkanaler, hvorved det afbryder synkroniseret neuronfyring, reducerer spredningen af krampeudladninger og afbryder den efterfølgende epileptiske aktivitet.
English: Anhidrosis
Danish: Anhidrose
English: Specialist advice should be given to women who are of childbearing potential regarding the possible effects of Zonegran on the foetus and these risks should be discussed with the patient in relation to the benefits before starting treatment.
Danish: Kvinder i den fertile alder skal rådgives af en specialist vedrørende Zonegrans mulige bivirkninger på fosteret, og disse risici bør drøftes med patienten i forhold til fordelene inden behandlingsstart.
English: The anticonvulsant activity of zonisamide has been evaluated in a variety of models, in several species with induced or innate seizures, and zonisamide appears to act as a broad-spectrum anti-epileptic in these models.
Danish: Zonisamids antikonvulsive virkning er blevet vurderet i forskellige modeller,og hos flere arter med inducerede eller medfødte krampeanfald; zonisamid ser ud til at virke som et bredspektret antiepileptikum i disse modeller.
English: Steady-state dosing of either ketoconazole (400 mg/day) or cimetidine (1200 mg/day) had no clinically relevant effects on the single-dose pharmacokinetics of zonisamide given to healthy subjects.
Danish: Steady-state-dosering af enten ketoconazol (400 mg dagligt) eller cimetidin (1.200 mg dagligt) havde ingen kliniske relevante virkninger på enkeltdosisfarmakokinetikken for zonisamid givet til raske forsøgspersoner.
English: The dose regime is 6-8 mg/kg/day up to a maximum dose of 500 mg/day.
Danish: Dosis er 6-8 mg/kg/dag op til en dosis på maksimalt 500 mg/dag.
English: In patients taking Zonegran who develop the clinical signs and symptoms of pancreatitis, it is recommended that pancreatic lipase and amylase levels are monitored.
Danish: Hos patienter, der tager Zonegran og som udvikler kliniske tegn og symptomer på pancreatitis, anbefales det at kontrollere niveauerne af pancreaslipase og amylase.
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 forbundet med supraciliær effusion, der fører til anterior forskydning af linsen og iris, med sekundært lukket-vinkel glaukom.
English: Possible side effects).
Danish: 4 Bivirkninger).
English: • have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones.
Danish: • De tidligere har lidt af nyresten, fordi De kan have en forhøjet risiko for at udvikle flere nyresten.
English: There are no clinical data available on the effects of zonisamide on human fertility.
Danish: Der foreligger ingen kliniske data om zonisamids virkning på human fertilitet.
English: Confusional state Acute psychosis Aggression Suicidal ideation Hallucination
Danish: Konfusion Akut psykose Aggression Selvmordstanker Hallucinationer
English: PVC/PVDC/aluminium blisters, packs of 14, 28, 56 and 84 hard capsules.
Danish: PVC/PVDC/aluminium blisters, pakninger med 14, 28, 56 og 84 hårde kapsler.
English: Zonisamide AUC and Cmax values increased almost linearly after single dose over the dose range of 100-800 mg and after multiple doses over the dose range of 100-400 mg once daily.
Danish: Zonisamid AUC- og Cmax-værdierne steg næsten lineært efter en enkelt dosis i et doseringsområde på 100-800 mg én gang dagligt og efter multiple doser i et doseringsområde på 100 - 400 mg én gang dagligt.
English: • swollen glands, blood disorders (reduction in the number of blood cells, which can make infection more likely and can make you look pale, feel tired and feverish, and bruise more easily).
Danish: • hævede lymfekirtler, blodsygdomme (nedsat antal blodceller, der kan øge sandsynligheden for, at De får en infektion og få Dem til at se bleg ud, føle træthed og feberagtig og lettere få blå mærker).
English: Zonegran must not be used during pregnancy unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus.
Danish: Zonegran må ikke anvendes under graviditet, medmindre det er klart nødvendigt, og kun hvis den potentielle nytte anses for at berettige risikoen for fostret.
English: • have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction.
Danish: • har åndedrætsbesvær, får hævelser i ansigtet, af læber eller tunge eller et alvorligt hududslæt, da disse symptomer kan være tegn på, at De har en alvorlig allergisk reaktion.
English: A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in adult and paediatric patients receiving zonisamide.
Danish: Et syndrom bestående af akut myopi forbundet med sekundært lukket-vinkel glaukom er blevet rapporteret hos voksne og pædiatriske patienter, der får zonisamid.
English: • Zonegran should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide.
Danish: • Zonegran skal anvendes med forsigtighed hos voksne, når det tages sammen med lægemidler, der kan give nyresten, som for eksempel topiramat eller acetazolamid.
English: Effect of food
Danish: Virkning af fødeindtagelse
English: The warnings and precautions mentioned above are also applicable to adolescent and paediatric patients.
Danish: De advarsler og forsigtighedsregler, der er nævnt herover, gælder også for unge og pædiatriske patienter.
English: Such electrolyte imbalance has been observed with the use of Zonegran in placebo-controlled clinical trials and in the post-marketing period.
Danish: En sådan elektrolyt-ubalance er blevet observeret i forbindelse med anvendelse af Zonegran i placebo-kontrollerede kliniske studier og i perioden efter markedsføringen.
English: 28 hard capsules 56 hard capsules 84 hard capsules 98 hard capsules 196 hard capsules
Danish: 28 hårde kapsler 56 hårde kapsler 84 hårde kapsler 98 hårde kapsler 196 hårde kapsler
English: Efficacy of zonisamide as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine prolonged release (PR) in 583 adult subjects with newly diagnosed partial seizures with or without secondary generalised tonic-clonic seizures.
Danish: Virkningen af zonisamid som monoterapi blev klarlagt i en dobbeltblindet, parallelgruppe noninferioritets-sammenligning versus carbamazepin-depotformulering (PR) hos 583 nydiagnosticerede voksne personer med partielle anfald med eller uden sekundært generaliserede tonisk-kloniske kramper.
English: If co-administration is necessary, the patient should be closely monitored and the dose of Zonegran and other CYP3A4 substrates adjusted as needed.
Danish: Hvis samtidig indgift er nødvendig, skal patienten kontrolleres tæt og Zonegrandosis og andre CYP3A4-substrater justeres efter behov.
English: Increased levels of hepatobiliary parameters such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) and bilirubin have occurred in paediatric and adolescent patients, without any consistent pattern in the observations of values above the upper limit of normal.
Danish: Forhøjede lever/galde-tal, såsom ALAT (alaninaminotransferase), ASAT (aspartataminotransferease), GGT (gamma-glutamyltransferase) og bilirubin er forekommet hos pædiatriske og unge patienter uden noget ensartet mønster for forekomsten af værdier over øvre normalgrænse.
English: Marketing Authorisation Holder Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germanye-mail: medinfo_de@eisai.net
Danish: Indehaver af markedsføringstilladelsen Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Tyskland e-mail: medinfo_de@eisai.net
English: The most common adverse reactions in controlled adjunctive-therapy studies were somnolence, dizziness and anorexia.
Danish: De mest almindelige bivirkninger i kontrollerede studier med supplerende behandlinger var døsighed, svimmelhed og anoreksi.
English: All patients who develop a rash while taking Zonegran must be closely supervised, with additional levels of caution applied to those patients receiving concomitant antiepileptic agents that may independently induce skin rashes.
Danish: Alle patienter, som udvikler et udslæt, mens de tager Zonegran, skal kontrolleres tæt med ekstra grad af forsigtighed over for de patienter, der får ledsagende antiepileptika, som uafhængigt kan fremkalde hududslæt.
English: If elevated, in the absence of another obvious cause such as trauma or grand mal seizures, it is recommended that Zonegran discontinuation be considered and appropriate treatment initiated.
Danish: Hvis de er forhøjet uden anden åbenlys årsag som f.eks. traume eller grand mal-anfald, anbefales det at overveje at seponere Zonegran og påbegynde passende behandling.
English: In clinical studies co-administration of lamotrigine had no apparent effect on zonisamide pharmacokinetics.
Danish: I kliniske studier havde samtidig indgift af lamotrigin ingen åbenbar virkning på zonisamids farmakokinetik.
English: System Organ Class (MedDRA terminology†)
Danish: Systemorganklasser (MedDRA-terminologi†)
English: Serious rashes occur in association with Zonegran therapy, including cases of Stevens-Johnson syndrome.
Danish: Der forekommer alvorlige udslæt i forbindelse med Zonegranbehandling, herunder tilfælde af Stevens-Johnsons syndrom.
English: In accordance with current clinical practice, discontinuation of Zonegran in patients with epilepsy must be accomplished by gradual dose reduction, to reduce the possibility of seizures on withdrawal.
Danish: I overensstemmelse med gængs klinisk praksis skal seponering af Zonegran hos patienter med epilepsi ske ved gradvis dosisreduktion for at reducere risikoen for anfald i forbindelse med seponering.
English: 14 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules
Danish: 14 hårde kapsler 28 hårde kapsler 56 hårde kapsler 84 hårde kapsler
English: Zonegran contains soya oil.
Danish: Zonegran indeholder sojaolie.
English: Recommended escalation and maintenance doses are given in Table 1.
Danish: Anbefalinger for dosistitrering og vedligeholdelsesdoser ses i tabel 1.
English: In paediatric patients (aged 6 years and above), efficacy has been demonstrated with zonisamide in a double-blind, placebo-controlled study, which included 207 subjects and had a treatment duration of up to 24 weeks.
Danish: Hos pædiatriske patienter (på 6 år og derover) er der vist virkning af zonisamid i et dobbeltblindt, placebokontrolleret studie, der omfattede 207 personer og havde en behandlingsvarighed på op til 24 uger.
English: The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min.
Danish: Plasma-AUC for zonisamid blev øget med 35 % hos personer med creatininclearance < 20 ml/min.
English: In vitro studies using human liver microsomes show no or little (<25%) inhibition of cytochrome P450 isozymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A4 at zonisamide levels approximately twofold or greater than clinically relevant unbound serum concentrations.
Danish: In vitro-studier med anvendelse af humane levermikrosomer viser ingen eller lille (<25 %) hæmning af CYP-isozymerne 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 eller 3A4 ved koncentrationer af zonisamid, der er omkring 2 gange eller større end klinisk relevante ubundne serumkoncentrationer.
English: In clinical studies in healthy subjects, steady-state dosing with Zonegran did not affect serum concentrations of ethinylestradiol or norethisterone in a combined oral contraceptive.
Danish: I kliniske studier af raske forsøgspersoner påvirkede steady-state-dosering med Zonegran ikke serumkoncentrationen af ethinylestradiol eller norethisteron i et kombineret oralt kontraceptivum.
English: Aggression Suicidal ideation Suicide attempt
Danish: Aggression Selvmordstanker Selvmordsforsøg
English: In a repeated-dose oral toxicity study in juvenile rats, at exposure levels similar to those observed in paediatric patients at the maximum recommended dose, decreases in body weight and changes in renal histopathology and clinical pathology parameters and behavioural changes were observed.
Danish: I et oralt toksicitetsstudie med gentagne doser hos unge rotter ved eksponeringsniveauer svarende til dem, der ses hos pædiatriske patienter ved den maksimalt anbefalede dosis, sås der fald i legemsvægt, ændringer i renal histopatologi og kliniske patologiparametre samt adfærdsændringer.
English: Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of Zonegran in these patients.
Danish: Der skal udvises forsigtighed i starten af behandlingen hos ældre patienter, da der foreligger begrænset information om brugen af Zonegran til disse patienter.
English: If substantial undesirable weight loss occurs, discontinuation of Zonegran should be considered.
Danish: Hvis der opstår et betydeligt uønsket vægttab, bør seponering af Zonegran overvejes.
English: PVC/PVDC/aluminium blisters, packs of 28, 56, 84, 98 and 196 hard capsules.
Danish: PVC/PVDC/aluminium blisters, pakninger med 28, 56, 84, 98 og 196 hårde kapsler.
English: Reduce the risk of kidney stones by drinking sufficient water.
Danish: Nedsæt risikoen for nyresten ved at drikke rigeligt med vand.
English: All generalized Tonic-Clonic Secondary Tonic-Clonic Generalized Tonic-Clonic
Danish: Sekundære tonisk-kloniske Generaliserede tonisk-kloniske
English: Reduce the risk of overheating by drinking sufficient water and keeping cool.
Danish: Nedsæt risikoen for hedeslag ved at drikke rigeligt med vand og undgå, at De får det for varmt.
English: • The capsule shell contains: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Danish: • Kapselskallen indeholder: gelatine, titandioxid (E171), shellac, propylenglycol, kaliumhydroxid, sort jernoxid (E172).
English: An in vitro study shows that zonisamide is a weak inhibitor of P-gp (MDR1) with an IC50 of 267 µmol/l and there is the theoretical potential for zonisamide to affect the pharmacokinetics of substances which are P-gp substrates.
Danish: Et in vitro-studie viser, at zonisamid er en svag hæmmer af P-glykoprotein (P-gp) (MDR1) med en IC50 på 267 µmol/l, og zonisamid kan i teorien påvirke farmakokinetikken for stoffer, der er P-gpsubstrater.
English: When you take Zonegran on its own:
Danish: Når De tager Zonegran alene:
English: Zonegran may cause weight loss.
Danish: Zonegran kan forårsage vægttab.
English: • are underweight, or have lost a lot of weight as Zonegran can cause you to lose more weight.
Danish: • De er undervægtig eller har haft et stort vægttab, fordi Zonegran kan betyde, at De taber Dem yderligere.
English: • have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems.
Danish: • har muskelsmerter eller føler Dem svag, da dette kan være et tegn på unormal muskelnedbrydelse, der kan føre til nyreproblemer.
English: Elevated intraocular pressure of any aetiology, if left untreated, can lead to serious sequelae including permanent vision loss.
Danish: Øget intraokulært tryk uanset ætiologi kan, hvis ubehandlet, medføre alvorlige sequelae, herunder permanent synstab.
English: Recommended escalation and maintenance doses are given in Table 2.
Danish: Anbefalinger for dosistitrering og vedligeholdelsesdoser ses i tabel 2.
English: • have signs of overheating - high body temperature but little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.
Danish: • har tegn på overophedning: høj kropstemperatur, men kun lidt eller ingen svedproduktion, hurtig puls og åndedræt, muskelkramper og forvirring.
English: Zonegran can make you perspire less, which can cause your body temperature to increase.
Danish: Zonegran kan betyde, at De sveder mindre, så Deres legemstemperatur eventuelt kan stige.
English: blurred vision or decreased vision may occur and can be signs of glaucoma.
Danish: Øjensmerter, sløret syn eller nedsat syn kan forekomme og kan være tegn på glaukom.
English: It should be noted that Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Danish: Det skal bemærkes, at Zonegran er et benzisoxazolderivat, som indeholder en sulfonamidgruppe.
English: • The other ingredients that are present in the capsule contents are: microcrystalline cellulose, hydrogenated vegetable oil (from soyabean) and sodium laurilsulfate.
Danish: • Øvrige indholdsstoffer i kapslen: mikrokrystallinsk cellulose, hydrogeneret vegetabilsk olie (fra soja) og natriumlaurilsulfat.
English: You might also feel sick, have a sore stomach, muscle twitches, eye movement, feel faint, have a slowed heart beat, and reduced breathing and kidney function.
Danish: De kan også føle Dem dårlig, have ondt i maven, få muskeltrækninger, øjenbevægelser, være ved at besvime, have en langsommere hjerterytme (puls) og en nedsat åndedræts- eller nyrefunktion.
English: Age ( 12 years) and gender, after adjustment for body weight effects, have no apparent effect on zonisamide exposure in epileptic patients during steady-state dosing.
Danish: Efter justering for virkningerne af legemsvægt synes alder ( 12 år) og køn ikke at have nogen virkning på eksponeringen for zonisamid hos epileptiske patienter ved steady-state-dosering.
English: - Enzyme induction: Exposure to zonisamide is lower in epileptic patients receiving CYP3A4-inducing agents such as phenytoin, carbamazepine, and phenobarbitone.
Danish: - Enzyminduktion: Eksponeringen for zonisamid er mindre hos epilepsipatienter, der får CYP3A4-induktorer såsom phenytoin, carbamazepin og phenobarbiton.
English: • are elderly, as your dose of Zonegran may need adjusting, and you may be more likely to develop an allergic reaction, severe skin rash, swelling of the feet and legs, and itchiness when taking Zonegran (see section 4 Possible side effects).
Danish: • De er ældre, fordi det kan være nødvendigt at justere Deres dosis af Zonegran, og De kan have en større risiko for at udvikle en allergisk reaktion, alvorligt hududslæt, hævede fødder og ben samt kløe, når De tager Zonegran (se pkt.
English: If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Zonegran (by gradual discontinuation or reduction of a therapeutic dose) as osteopenia may develop.
Danish: Hvis der udvikles vedvarende metabolisk acidose, kan det overvejes at reducere dosis eller seponere Zonegran (ved gradvis dosisreduktion), da der kan udvikles osteopeni.
English: • On its own to treat seizures in adults.
Danish: • Som eneste lægemiddel til behandling af anfald hos voksne.
English: Therefore, modification of Zonegran dosing should not be necessary when co-administered with known CYP3A4 inhibitors.
Danish: Ændring af Zonegrandosis skulle derfor ikke være nødvendig, når det gives samtidigt med kendte CYP3A4hæmmere.
English: • get a sudden pain in your back or stomach, have pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones.
Danish: • De pludselig får smerter i ryggen eller maven, har smerter ved vandladning (når De tisser) eller bemærker blod i urinen, da dette kan være tegn på nyresten.
English: • feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder.
Danish: • føler Dem usædvanlig træt eller feberagtig, får ondt i halsen, hævede kirtler eller bemærker, at De lettere får blå mærker, da dette kan betyde, at De har en blodsygdom.
English: • abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems.
Danish: • unormal muskelnedbrydelse (De kan have muskelsmerter eller muskelsvaghed), der kan medføre nyreproblemer.
English: Zonegran with food and drink Zonegran can be taken with or without food.
Danish: Zonegran kan tages sammen med eller uden mad.
English: - 25 mg: 14, 28, 56 and 84 capsules - 50 mg: 14, 28, 56 and 84 capsules - 100 mg: 28, 56, 84, 98 and 196 capsules.
Danish: Zonegran kapsler er pakket i blisterpakninger og udleveres i æsker, der indeholder - 25 mg: 14, 28, 56 og 84 kapsler - 50 mg: 14, 28, 56 og 84 kapsler - 100 mg: 28, 56, 84, 98 og 196 kapsler
English: In the event of signs or symptoms of dehydration, oligohydrosis, or elevated body temperature, discontinuation of Zonegran should be considered.
Danish: Ved tegn og symptomer på dehydrering, nedsat svedtendens eller forhøjet legemstemperatur skal det overvejes at seponere Zonegran.