FrancophonIA/ELRC3.0 huggingface dataset:
English: • Body weight: You should monitor your child's weight every month and see your doctor as soon as possible if your child is not gaining enough weight.
Danish: • Legemsvægt: De skal kontrollere barnets vægt hver måned og kontakte lægens snarest muligt, hvis barnet ikke tager tilstrækkelig på.
English: Be especially careful while driving or operating machinery, if Zonegran affects you in this way.
Danish: Vær særlig forsigtig, når De fører motorkøretøj eller betjener maskiner, hvis Zonegran påvirker Dem på denne måde.
English: Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg:
Danish: Brug til børn (i alderen 6-11 år) og unge (i alderen 12-17 år), som vejer mindst 20 kg:
English: • Do not take double the dose to make up for the forgotten dose.
Danish: • De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • Zonegran can be taken once or twice daily, as instructed by your doctor.
Danish: • Zonegran kan tages én eller to gange dagligt efter lægens anvisning.
English: Elderly: No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
Danish: Ældre: Der blev ikke observeret klinisk signifikante forskelle i farmakokinetikken mellem unge (i alderen 21-40 år) og ældre (65-75 år).
English: If you are younger than 6 years old, Zonegran is not recommended for you.
Danish: Hvis De er yngre end 6 år, frarådes Zonegran til Dem.
English: Erythrocyte/plasma ratios are about 15 at low concentrations and about 3 at higher concentrations.
Danish: Erytrocyt/plasma-forholdet er omkring 15 ved lave koncentrationer og omkring 3 ved højere koncentrationer.
English: • are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility' for further information).
Danish: • De er gravid eller kan blive gravid (se punktet "Graviditet, amning og frugtbarhed" for at få yderligere oplysninger).
English: Your doctor may decide that you should stop using Zonegran.
Danish: Deres læge kan beslutte, at De skal holde op med at tage Zonegran.
English: • Some people respond to lower doses.
Danish: • Nogle personer kan reagere på lavere doser.
English: The first-pass metabolism is believed to be negligible.
Danish: First-pass metabolismen menes at være ubetydelig.
English: Note: a. To ensure a therapeutic dose is maintained the weight of a child should be monitored and the dose reviewed as weight changes occur up to a weight of 55kg.
Danish: Bemærk: a. For at sikre opretholdelse af en terapeutisk dosis skal barnets vægt monitoreres og dosis justeres i henhold til ændringer i vægten op til en vægt på 55 kg.
English: The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medicinal product.
Danish: Risikoen for medfødt misdannelse øges med faktor 2 til 3 for børn af mødre, der er behandlet med et antiepileptikum.
English: Zonegran may affect your concentration, ability to react/respond, and may make you feel sleepy, particularly at the beginning of your treatment or after your dose is increased.
Danish: Zonegran kan påvirke Deres koncentration og Deres evne til at reagere/respondere og kan få Dem til at blive søvnig, især i begyndelsen af behandlingen eller efter, at Deres dosis er øget.
English: • Sponge your child's skin with cool (not cold) water
Danish: • Dup barnets hud med køligt (ikke koldt) vand
English: • If your doctor advises you to stop taking Zonegran your dose will be reduced gradually to lower the risk of more seizures.
Danish: • Hvis Deres læge råder Dem til at ophøre med at tage Zonegran, vil Deres dosis gradvis blive reduceret for at mindske risikoen for flere anfald.
English: Make sure you are fully informed about the risks and the benefits of using zonisamide for epilepsy during pregnancy.
Danish: Sørg for, at du har fået alle oplysninger om risici og fordele ved brug af zonisamid mod epilepsi under graviditet.
English: • It you take Zonegran twice a day, take half the daily dose in the morning and half in the evening.
Danish: • Hvis De tager Zonegran to gange dagligt, skal De tage den ene halvdel af den daglige dosis om morgenen og den anden halvdel om aftenen.
English: Sulphonamide reactions
Danish: Sulfonamidreaktioner
English: You must only take Zonegran during your pregnancy if your doctor tells you to. Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Danish: De må kun tage Zonegran under Deres graviditet, hvis Deres læge siger, at De skal gøre det. Forskning har vist en øget risiko for medfødte misdannelser hos børn af kvinder, der tager medicin mod epilepsi.
English: An updated RMP should be submitted: o At the request of the European Medicines Agency; o Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: o på anmodning fra det Europæiske Lægemiddelagentur o når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk -forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke udført studier af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: In addition there have been isolated cases of Sudden Unexplained Death in Epilepsy Patients (SUDEP) receiving Zonegran.
Danish: Desuden har der været isolerede tilfælde af pludselig uforklarlig død hos epilepsipatienter (SUDEP), der har fået Zonegran.
English: Generally, zonisamideinduced metabolic acidosis occurs early in treatment although cases can occur at any time during treatment.
Danish: Almindeligvis forekommer zonisamid-induceret metabolisk acidose tidligt i behandlingen, selv om der kan forekomme tilfælde på et hvilket som helst tidspunkt under behandlingen.
English: • swelling of the feet and legs.
Danish: • hævede fødder og ben.
English: Zonegran hard capsules are for oral use.
Danish: Zonegran kapsel, hård er til oral anvendelse.
English: It is not always possible to precisely achieve the calculated dose with the commercially available capsule strengths of Zonegran.
Danish: Det er ikke altid muligt at opnå den beregnede dosis præcist med de kommercielt tilgængelige kapselstyrker af Zonegran.
English: Contact your doctor as soon as possible if you:
Danish: De skal kontakte Deres læge snarest muligt, hvis De:
English: Zonegran has been administered to over 1,200 patients in clinical studies, more than 400 of whom received Zonegran for at least 1 year.
Danish: Zonegran er givet til 1.200 patienter i kliniske studier, hvoraf mere end 400 fik Zonegran i mindst 1 år.
English: Return the pack to your pharmacist.
Danish: Aflevér pakken på apoteket.
English: Zonegran is indicated as:
Danish: Zonegran er indiceret som:
English: Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Patienterne bør derfor kontrolleres for tegn på selvmordstanker og -adfærd, og passende behandling bør overvejes.
English: • glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye.
Danish: • glaukom, som er en blokering af væske i øjet, hvilket forårsager øget tryk i øjet.
English: In these cases it is therefore recommended that the Zonegran total dose should be rounded up or down to the nearest available dose that can be achieved with commercially available capsule strengths of Zonegran (25 mg, 50 mg and 100 mg).
Danish: I disse tilfælde anbefales det derfor, at den totale dosis Zonegran rundes op eller ned til den nærmest tilgængelige dosis, der kan opnås med de kommercielt tilgængelige kapselstyrker af Zonegran (25 mg, 50 mg og 100 mg).
English: • Zonegran is meant to be taken as a long-term medicine.
Danish: • Zonegran er beregnet til at blive taget som langtidsbehandling.
English: Parent drug and SMAP can additionally be glucuronidated.
Danish: Moderstof og SMAP kan yderligere blive glukuronideret.
English: Eisai Manufacturing Ltd European Knowledge Centre Mosquito Way
Danish: Eisai Manufacturing Ltd European Knowledge Centre Mosquito Way Hatfield
English: At a higher dose level (2-3-fold systemic exposure compared to therapeutic exposure) renal histopathological effects were more severe and only partially reversible.
Danish: Ved et højere dosisniveau (systemisk eksponering på 2-3 gange i forhold til den terapeutiske eksponering) var de renale histopatologiske virkninger alvorligere og kun delvist reversible.
English: If any of these applies to you, tell your doctor before you take Zonegran.
Danish: Hvis et af punkterne gælder for Dem, skal De fortælle det til Deres læge, før De tager Zonegran.
English: Cognitive impairment in patients affected by epilepsy has been associated with the underlying pathology and/ or the administration of anti-epileptic treatment.
Danish: Kognitiv svækkelse hos patienter med epilepsi har været forbundet med den underliggende patologi og/eller administration af antiepileptika.
English: General dosing recommendations for Zonegran in special patient populations
Danish: Generelle dosisanbefalinger for Zonegran hos specielle patientpopulationer
English: Zonisamide exposure increases with time until steady state is achieved by approximately 8 weeks.
Danish: Eksponeringen for zonisamid øges med tiden, indtil steady-state nås efter ca. 8 uger.
English: Suicide ideation and behaviour
Danish: Selvmordstanker og -adfærd
English: Do not use this medicine if you notice any damage to the capsules, blister or carton or any visible signs of deterioration in the medicine.
Danish: Brug ikke lægemidlet, hvis kapsler, blisters eller karton er beskadiget, eller hvis der er synlige tegn på forringelse af medicinen.
English: Eisai Manufacturing Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.
Danish: Eisai Manufacturing Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, Storbritannien.
English: Decrease at weekly intervals in increments of: 20 - 28 kg 25 to 50 mg / day* 29 - 41 kg 50 to 75 mg / day* 42 - 55 kg 100 mg / day* >55 kg
Danish: Nedsæt med ugentlige intervaller i trin af: 20-28 kg 25-50 mg/dag* 29-41 kg 50-75 mg/dag* 42-55 kg 100 mg/dag* > 55 kg
English: No specific antidotes for Zonegran overdose are available.
Danish: Der findes ingen specifikke antidoter til Zonegranoverdosering.
English: A small number of people being treated with antiepileptics such as Zonegran have had thoughts of harming or killing themselves.
Danish: Nogle få mennesker, der er blevet behandlet med medicin mod epilepsi som f.eks. Zonegran, har haft tanker om at skade sig selv eller begå selvmord.
English: Zonegran is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg.
Danish: Zonegran frarådes til børn, som er undervægtige eller har lille appetit, og skal bruges med forsigtighed til børn, som vejer under 20 kg.
English: There are limited data from the use of Zonegran in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af Zonegran til gravide kvinder.
English: Treatment includes discontinuation of zonisamide, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure.
Danish: Behandlingen omfatter seponering af zonisamid, så hurtigt som muligt efter den behandlende læges bedømmelse, og passende foranstaltninger for at nedsætte det intraokulære tryk.
English: • have eye problems such as glaucoma.
Danish: • De har øjenproblemer, såsom glaukom.
English: • agitation, irritability, confusion, depression
Danish: • uro, irritabilitet, forvirring, depression
English: These studies show that the median reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
Danish: Disse studier viser, at den mediane reduktion i partiel krampefrekvens er relateret til Zonegrandosis med vedvarende effekt i doser på 300-500 mg dagligt.
English: Fluctuation in serum or plasma concentrations over a dosing interval is low (< 30 %).
Danish: Svingninger i serum- eller plasmakoncentrationer i løbet af et dosisinterval er små (< 30 %).
English: Zonisamide was not genotoxic and has no carcinogenic potential.
Danish: Zonisamid var ikke genotoksisk og er ikke karcinogent.
English: When you take Zonegran with other antiepileptic medicines:
Danish: Når De tager Zonegran sammen med andre antiepileptika:
English: Important information about some of the ingredients of Zonegran
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Zonegran
English: When comparing the same dose level, subjects of higher total body weight appear to have lower steady-state serum concentrations, but this effect appears to be relatively modest.
Danish: Ved sammenligning af samme dosisniveau synes patienter med højere total legemsvægt at have lavere serumkoncentrationer ved steady-state, men denne virkning synes at være forholdsvis beskeden.
English: Zonegran may be used:
Danish: Zonegran kan anvendes:
English: Zonisamide also has a modulatory effect on GABA-mediated neuronal inhibition.
Danish: Zonisamid har også en modulerende virkning på GABA-medieret neuronhæmning.
English: Zonegran is not recommended for paediatric patients who are underweight (definition in accordance with the WHO age adjusted BMI categories) or have a decreased appetite.
Danish: Zonegran frarådes til pædiatriske patienter, som er undervægtige (defineret i henhold til WHOs aldersjusterende BMI-kategorier) eller har nedsat appetit.
English: • severe rashes or skin peeling (at the same time you may feel unwell or develop a fever).
Danish: • alvorlige udslæt eller afskalning af huden (samtidig kan De føle utilpashed eller udvikle feber).
English: If you may have taken more Zonegran than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you.
Danish: Hvis De har taget for meget Zonegran, skal De omgående fortælle det til den, der tager sig af Dem (slægtning eller ven), Deres læge eller apotekspersonalet, eller De skal kontakte den nærmeste skadestue og tage Deres medicin med Dem.
English: • difficulty sleeping, strange or unusual thoughts, feeling anxious or emotional.
Danish: • søvnproblemer, mærkelige eller usædvanlige tanker, angst eller følelsesmæssige problemer.
English: Children and adolescents Talk to your doctor about the following risks:
Danish: Tal med lægen om følgende risici:
English: If Zonegran is prescribed during pregnancy, patients should be fully informed of the potential harm to the foetus and use of the minimal effective dose is advised along with careful monitoring.
Danish: Hvis Zonegran ordineres under graviditet, skal patienterne informeres grundigt om den potentielle skade på fosteret, og brugen af minimal effektiv dosis anbefales sammen med omhyggelig kontrol.
English: 300 to 500 mg for a child with a body weight more than 55 kg (which ever dose is lower) taken once a day.
Danish: 300-500 mg til et barn med en legemsvægt på over 55 kg (hvis den dosis er lavere) én gang dagligt.
English: If you feel that the effect of Zonegran is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis De mener, at virkningen af Zonegran er for kraftig eller for svag, bør De tale med Deres læge eller apotekspersonalet herom.
English: Children and adolescents (5-18 years): Limited data indicate that pharmacokinetics in children and adolescents dosed to steady state at 1, 7 or 12 mg/kg daily, in divided doses, are similar to those observed in adults, after adjustment for bodyweight.
Danish: Børn og unge (5-18 år): Begrænsede data tyder på, at farmakokinetikken hos børn og unge, som doseres til steady-state med 1, 7 eller 12 mg/kg dagligt i delte doser, er den samme, som blev observeret hos voksne efter korrektion for legemsvægt.
English: Zonegran is used to treat seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation).
Danish: Zonegran anvendes til behandling af anfald, der påvirker en del af hjernen (partielle anfald), og som eventuelt kan efterfølges af et anfald, der påvirker hele hjernen (sekundær generalisering).
English: • Seek urgent medical assistance.
Danish: • Søg straks læge.
English: Week 3 to 5
Danish: Uge 3 til 5
English: • inflammations of the pancreas (severe pain in the stomach or back)
Danish: • betændelse i bugspytkirtlen (stærke smerter i mave eller ryg).
English: • anger, aggression, thoughts of suicide, suicide attempt.
Danish: • vrede, aggressivitet, selvmordstanker, selvmordsforsøg.
English: Potential for Zonegran to affect other medicinal products
Danish: Zonegrans mulighed for at indvirke på andre lægemidler
English: Rifampicin is a potent CYP3A4 inducer.
Danish: Rifampicin er en potent CYP3A4-induktor.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Danish: Patienterne (og patienternes behandlere) skal tilrådes at søge lægelig rådgivning, hvis der skulle opstå tegn på selvmordstanker og -adfærd.
English: Potential medicinal product interactions affecting Zonegran
Danish: Mulige lægemiddelinteraktioner, der kan påvirke Zonegran
English: • Zonegran could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
Danish: • Zonegran kan øge koncentrationen i blodet af lægemidler som digoxin og quinidin, og det kan være nødvendigt at nedsætte dosis heraf.
English: • Do not chew the capsules.
Danish: • Kapslerne må ikke tygges.
English: Paediatric population).
Danish: Pædiatrisk population).
English: Zonegran may be taken as monotherapy or added to existing therapy in adults.
Danish: Zonegran kan tages som monoterapi eller lægges til eksisterende behandling hos voksne.
English: Contact your doctor immediately if you:
Danish: Tag omgående kontakt til Deres læge, hvis De:
English: Symptoms include acute onset of decreased visual acuity and/or ocular pain.
Danish: Symptomerne omfatter akut opstået nedsat synsskarphed og/eller okulære smerter.
English: • The recommended daily dose is 6 to 8 mg per kg for a child with a body weight of up to 55 kg or
Danish: • Den anbefalede daglige dosis er 6-8 mg pr. kg for et barn med en legemsvægt på op til 55 kg og
English: Titanium dioxide (E171) Shellac
Danish: Titandioxid (E171) Shellac
English: A meta-analysis of randomised placebo-controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Danish: En meta-analyse af randomiserede placebo-kontrollerede studier af antiepileptika har også vist en let øget risiko for selvmordstanker og -adfærd.
English: Posology - Adults
Danish: Dosering - voksne
English: • develop visual problems such as eye pain or blurred vision while taking Zonegran
Danish: • udvikler synsproblemer, såsom øjensmerter eller sløret syn, når De tager Zonegran.
English: • The starting dose is 50 mg daily taken in two equal doses of 25 mg.
Danish: • Startdosis er 50 mg dagligt indtaget i to lige store doser på 25 mg.
English: Zonegran must be added to existing therapy for paediatric patients aged 6 years and above.
Danish: Zonegran skal lægges til eksisterende behandling hos pædiatriske patienter på 6 år og derover.
English: • poor muscle coordination, dizziness, poor memory, sleepiness, double vision
Danish: • dårlig muskelkoordinering, svimmelhed, dårlig hukommelse, søvnighed, dobbeltsyn
English: Talk to your doctor or pharmacist before taking Zonegran if you:
Danish: Kontakt lægen eller apotekspersonalet, før De tager Zonegran, hvis
English: - CYP3A4 inhibition: Based upon clinical data, known specific and non-specific CYP3A4 inhibitors appear to have no clinically relevant effect on zonisamide pharmacokinetic exposure parameters.
Danish: - CYP3A4-hæmning: Baseret på kliniske data synes kendte og ukendte uspecifikke CYP3A4hæmmere ikke at have klinisk relevant virkning på zonisamids farmakokinetiske eksponeringsparametre.
English: Zonegran may be taken with or without food (see section 5.2).
Danish: Zonegran kan indtages sammen med eller uden mad (se pkt.
English: Hatfield, Hertfordshire, AL10 9SN United Kingdom
Danish: Hertfordshire AL10 9SN Storbritannien
English: Caution is advised when starting or stopping zonisamide treatment or changing the zonisamide dose in patients who are also receiving medicinal products which are P-gp substrates (e.g. digoxin, quinidine).
Danish: Det tilrådes at udvise forsigtighed, når zonisamid-behandling iværksættes eller standses, eller når zonisamid-dosis ændres hos patienter, som også får lægemidler, der er substrater for P-gp (f.eks. digoxin, kinidin).
English: • Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood levels of Zonegran, which may require an adjustment of your dose of Zonegran.
Danish: • Andre lægemidler såsom phenytoin, carbamazepin, phenobarbital og rifampicin kan nedsætte koncentrationen af Zonegran i blodet, hvilket kan kræve en justering af Deres Zonegrandosis.
English: Capsule shells Gelatin
Danish: Kapselskal Gelatine
English: Physicians treating patients with Zonegran should ensure that patients are fully informed about the need to use appropriate effective contraception, and should use clinical judgement when assessing whether oral contraceptives (OCs), or the doses of the OC components, are adequate based on the individual patient's clinical situation.
Danish: Læger, der behandler patienter med Zonegran, skal sikre, at patienterne er grundigt informeret om behovet for brug af passende, sikker kontraception og bør anvende klinisk skøn ved vurderingen af, hvorvidt orale kontraceptiva eller doseringen af bestanddelene i orale kontraceptiva er passende, baseret på den enkelte patients kliniske situation.
English: PP-population* ITT-population < 4 seizures during 3 month baseline period > 4 seizures during 3 month baseline period
Danish: PP-population* ITT-population < 4 anfald i løbet af 3måneders-baselineperioden > 4 anfald i løbet af 3måneders-baselineperioden
English: • ecchymosis (a small bruise caused by blood leaking from broken blood vessels in the skin).
Danish: • ekkymose (blodudtræden, der skyldes blødning fra ødelagte blodkar i huden).
English: • have an unexplained skin rash, as this could develop into a more severe skin rash or skin peeling.
Danish: • får et uforklarligt hududslæt, da dette kan udvikle sig til et mere alvorligt hududslæt eller afskalning af huden.
English: • Increased acid level in the blood and kidney stones: Reduce these risks by ensuring that your child drinks enough water and is not taking any other medicine which could cause kidney stones (see Other medicines).
Danish: • Forhøjet syreniveau i blodet samt nyresten: Disse risici skal reduceres ved at sikre, at barnet drikker tilstrækkeligt vand og ikke tager anden medicin, der kan forårsage nyresten (se Brug af anden medicin).
English: Due to the long retention time of zonisamide in the body, breast-feeding must not be resumed until one month after Zonegran therapy is completed.
Danish: På grund af lang retentionstid for zonisamid i organismen bør amning ikke genoptages før en måned efter, at behandlingen med Zonegran er afsluttet.
English: In children, this combination is not recommended
Danish: Denne kombination frarådes til børn.
English: The most common side effects of Zonegran are mild.
Danish: De hyppigste bivirkninger ved Zonegran er lette.