FrancophonIA/ELRC3.0 huggingface dataset:
English: Zonisamide can cause children to sweat less and overheat and if the child is not treated this can lead to brain damage and death.
Danish: Zonisamid kan få børn til at svede mindre og blive overophedet, og hvis barnet ikke behandles, kan det medføre hjerneskade og død.
English: Patients or their carers must be warned to take care to maintain hydration and avoid exposure to excessive temperatures and strenuous physical exercise depending on the condition of the patient.
Danish: Patienter eller deres omsorgsgivere skal gøres opmærksomme på at opretholde væskebalancen og undgå meget høje temperaturer og anstrengende fysisk udfoldelse, afhængigt af patientens tilstand.
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 substrat for P-gp (fx digoxin, kinidin).
English: Nephrolithiasis may lead to chronic kidney damage.
Danish: Nephrolithiasis kan medføre kroniske nyreskader.
English: In other cases, the overdose was followed by symptoms such as somnolence, nausea, gastritis, nystagmus, myoclonus, coma, bradycardia, reduced renal function, hypotension and respiratory depression.
Danish: I andre tilfælde blev overdoseringen efterfulgt af symptomer som døsighed, kvalme, gastritis, nystagmus, myoklonier, koma, bradycardi, nedsat nyrefunktion, hypotension og respirationsdepression.
English: Specialist advice should be given to women who are of childbearing potential regarding the possible effects of zonisamide 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 zonisamids mulige bivirkninger på fosteret, og disse risici bør drøftes med patienten i forhold til fordelene inden behandlingsstart.
English: In a zonisamide placebo-controlled study conducted in paediatric and adolescent patients, the proportion of patients with impaired cognition was numerically greater in the zonisamide group compared with the placebo group.
Danish: I et placebokontrolleret studie af zonisamid hos pædiatriske og unge patienter var andelen af patienter med nedsat kognition numerisk større i zonisamidgruppen end i placebogruppen.
English: Appropriate evaluation and monitoring of serum bicarbonate levels should be carried out in patients taking zonisamide who have underlying conditions which might increase the risk of acidosis, in patients who are at an increased risk of adverse consequences of metabolic acidosis and in patients with symptoms suggestive of metabolic acidosis.
Danish: Der skal foretages passende vurdering og monitorering af serum-hydrogencarbonat hos patienter, der tager zonisamid, og som har underliggende sygdomme, der vil kunne øge risikoen for acidose, hos patienter, der har øget risiko for skadelige følger af metabolisk acidose, og hos patienter med symptomer, der minder om metabolisk acidose.
English: Zonisamide 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: Zonisamid må ikke anvendes under graviditet, medmindre det er klart nødvendigt, og kun hvis den potentielle nytte anses for at berettige risikoen for fostret.
English: Weight loss leading to deterioration of general condition and failure to take anti-epilepsy medication has been related to a fatal outcome (see section 4.8).
Danish: Vægttab, der medfører forringelse af almentilstanden og undladelse af at tage antiepileptika har været forbundet med dødelig udgang (se pkt.
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: ≥ 1/100 to < 1/10
Danish: ≥ 1/100 til < 1/10
English: If co-administration is necessary, the patient should be closely monitored and the dose of zonisamide and other CYP3A4 substrates adjusted as needed.
Danish: Hvis samtidig indgift er nødvendig, skal patienten kontrolleres tæt og zonisamiddosis og andre CYP3A4-substrater justeres efter behov.
English: Potential for zonisamide to affect other medicinal products Anti-epileptic medicinal products
Danish: Zonisamids mulighed for at indvirke på andre lægemidler
English: Although not formally studied for the treatment of overdose, haemodialysis reduced plasma concentrations of zonisamide in a patient with reduced renal function, and may be considered as treatment of overdose if clinically indicated.
Danish: Selvom det ikke er undersøgt på formaliseret måde til behandling af overdosering, reducerede hæmodialyse plasmakoncentrationen af zonisamid hos en patient med nedsat nyrefunktion og det kan måske overvejes som behandling af overdosering, hvis det klinisk er indiceret.
English: The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in younger patients.
Danish: Risikoen for zonisamid-induceret metabolisk acidose synes at være hyppigere og mere alvorlig hos yngre patienter.
English: 100 mg / day*
Danish: 100 mg/dag*
English: Therefore children aged 6 years and above with a body weight of less than 20 kg should be treated with caution.
Danish: Derfor skal børn på 6 år og derover med legemsvægt under 20 kg behandles med forsigtighed.
English: In patients taking zonisamide 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 zonisamid og som udvikler kliniske tegn og symptomer på pancreatitis, anbefales det at kontrollere pancreaslipase og amylase.
English: Confusional state Acute psychosis Aggression Suicidal ideation Hallucination
Danish: Konfusion Akut psykose Aggression Suicidale tanker Hallucinationer
English: The most common adverse reactions in controlled adjunctive-therapy studies were somnolence, dizziness and anorexia.
Danish: De hyppigste bivirkninger i kontrollerede studier med supplerende behandlinger var døsighed, svimmelhed og anoreksi.
English: Since zonisamide and its metabolites are excreted renally, it should be discontinued in patients who develop acute renal failure or where a clinically significant sustained increase in serum creatinine is observed.
Danish: Da zonisamid og dets metabolitter udskilles renalt, bør det seponeres hos patienter, som udvikler akut nyreinsufficiens eller hvor der observeres en klinisk betydningsfuld vedvarende stigning i serumcreatinin.
English: Prescribers should also take account of the safety profile of zonisamide (see section 4.8).
Danish: De ordinerende læger bør også tage hensyn til zonisamid sikkerhedsprofil (se pkt.
English: • Take the child to a cool, shaded place
Danish: • Barnet skal flyttes til et køligt sted i skyggen
English: Specific safety issues that were encountered in the paediatric studies were: decreased appetite and weight loss, decreased bicarbonate levels, increased risk of kidney stones and dehydration.
Danish: Særlige sikkerhedsmæssige forhold, der forekom i de pædiatriske studier, var: Nedsat appetit og vægttab, lave hydrogencarbonatniveauer, øget risiko for nyresten og dehydrering.
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients.
Danish: Tilfælde med nedsat svedproduktion og forhøjet legemstemperatur er blevet rapporteret hovedsagelig hos pædiatriske patienter.
English: This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of zonisamide on carbonic anhydrase.
Danish: Denne metaboliske acidose er forårsaget af et renalt hydrogencarbonattab på grund af den hæmmende virkning af zonisamid på kulsyreanhydrasen.
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: Vedligeholdelsesdosering af enten ketoconazol (400 mg dagligt) eller cimetidin (1200 mg dagligt) havde ingen kliniske relevante virkninger på enkeltdosisfarmakokinetikken for zonisamid givet til raske forsøgspersoner.
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 two-fold 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: All patients who develop a rash while taking zonisamide 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 zonisamid, skal kontrolleres tæt med ekstra grad af forsigtighed over for de patienter, der får ledsagende antiepileptika, som uafhængigt kan fremkalde hududslæt.
English: A small number of people being treated with antiepileptics such as zonisamide have had thoughts of harming or killing themselves.
Danish: Et mindre antal patienter behandlet med antiepiliptika såsom zonisamid har haft suicidale tanker eller tanker om at gøre skade på sig selv.
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: 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 superciliær effusion, som kan medføre en forskydning af linsen og iris med sekundær glaucoma angulo clauso.
English: The most frequently reported are cleft lip, cardiovascular malformations and neural tube defect.
Danish: De hyppigst rapporterede er læbespalte, kardiovaskulære misdannelser og neuralrørsdefekt.
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 patienter med creatininclearance < 20 ml/min.
English: Aspartate aminotransferase increased
Danish: Forhøjet alaninaminotransferase Forhøjet aspartataminotransferase
English: Potential medicinal product interactions affecting zonisamide In clinical studies co-administration of lamotrigine had no apparent effect on zonisamide pharmacokinetics.
Danish: Mulige lægemiddelinteraktioner, der kan påvirke zonisamid I kliniske studier havde samtidig indgift af lamotrigin ingen åbenbar virkning på zonisamids farmakokinetik.
English: Recommended escalation and maintenance doses are given in Table 2.
Danish: Anbefalinger for dosisøgning og vedligeholdelsesdoser ses i Tabel 2.
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-gp substrater.
English: Aggression Suicidal ideation Suicide attempt
Danish: Aggression Suicidaltanker Selvmordsforsøg
English: Weight loss is potentially more serious in children (see section 4.4.
Danish: Vægttab kan være mere alvorligt hos børn (se pkt.
English: Recommended escalation and maintenance doses are given in Table 1.
Danish: Anbefalinger for dosisøgning og vedligeholdelsesdoser ses i Tabel 1.
English: Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation in adults
Danish: Supplerende terapi til behandling af partielle anfald med eller uden sekundær generalisering hos voksne
English: Respiratory disorder
Danish: Respirationsforstyrrelser
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 dosis er 6 til 8 mg pr. kg for et barn, som vejer op til 55 kg, eller 300 mg til
English: The incidence of a decrease in body weight of 10% or more was 10.7% (see section 4.4).
Danish: Vægttab på 10 % eller derover forekom hos 10,7 % (se pkt.
English: Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria.
Danish: Risikofaktorer for nephrolithiasis er bl.a. tidligere stendannelse, familieanamnese med nephrolithiasis og hyperkalcuri.
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 menneskets fertilitet.
English: In clinical studies in healthy subjects, steady-state dosing with zonisamide did not affect serum concentrations of ethinylestradiol or norethisterone in a combined oral contraceptive.
Danish: I kliniske studier af raske forsøgspersoner påvirkede ligevægtsdosering med Zonisamid ikke serumkoncentrationen af ethinylestradiol eller norethisteron i et kombineret oralt kontraceptivum.
English: Serious rashes occur in association with zonisamide therapy, including cases of Stevens-Johnson syndrome.
Danish: Der forekommer alvorlige udslæt i forbindelse med zonisamidbehandling, herunder tilfælde af Stevens-Johnsons syndrom.
English: ≥ 1/10,000 to < 1/1,000
Danish: ≥ 1/10.000 til < 1/1.000
English: In accordance with current clinical practice, discontinuation of zonisamide 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 zonisamid hos patienter med epilepsi ske ved gradvis dosisreduktion for at reducere risikoen for anfald i forbindelse med seponering.
English: If a higher dose is required: increase at two-weekly intervals in increments of 100 mg up to a maximum of 500 mg.
Danish: Hvis der er behov for en højere dosis: Dosis øges med 100 mg med 2 ugers intervaller op til maksimalt 500 mg.
English: Caution should be exercised at initiation of treatment in elderly patients as there is limited information on the use of zonisamide in these patients.
Danish: Der skal udvises forsigtighed i starten af behandlingen hos ældre patienter, da der foreligger begrænset information om brugen af zonisamid til disse patienter.
English: Zonisamide Mylan 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: Zonisamide Mylan anvendes til behandling af anfald, der starter i en afgrænset del af hjernen (partielle anfald), og som eventuelt kan brede sig til hele hjernen (sekundær generalisering).
English: It is an anti-epileptic medicine with weak carbonic anhydrase activity in-vitro.
Danish: Det er et antiepileptikum med en svag kulsyreanhydrasevirkning in-vitro.
English: Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric lamellar bodies in the cytoplasm and cytoplasmic vacuolation) associated with increased metabolism.
Danish: Fund, der ikke blev iagttaget i kliniske studier, men blev set hos hunde ved lignende eksponeringsniveauer svarende til klinisk anvendelse, var leverskader (forstørrelse, mørkebrun misfarvning, let hepatocytforstørrelse med koncentriske lamellære legemer i cytoplasmaet og cytoplasmatisk vakuolisering) forbundet med øget metabolisme.
English: Cholecystitis acute
Danish: Akut cholecystitis
English: Monotherapy in partial seizures, with or without secondary generalisation Efficacy of zonisamide as monotherapy was established in a double-blind, parallel group, non-inferiority comparison to carbamazepine prolonged release (PR) in 583 adult subjects with newly diagnosed partial seizures with or without secondary generalised tonic-clonic seizures.
Danish: Monoterapi til partielle anfald med eller uden sekundær generalisering 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: - Zonisamide Mylan should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide.
Danish: • Zonisamide Mylan skal anvendes med forsigtighed hos voksne, når det tages sammen med lægemidler, der kan give nyresten, som for eksempel topiramat eller acetazolamid.
English: If elevated, in the absence of another obvious cause such as trauma or grand mal seizures, it is recommended that zonisamide discontinuation be considered and appropriate treatment initiated.
Danish: Hvis de er forhøjet uden anden årsag som f.eks. traume eller grand mal anfald, anbefales det at overveje at seponere zonisamid og påbegynde passende behandling.
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 toksicitetsstudier 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: Rash Pruritus Alopecia
Danish: Udslæt Pruritus Alopeci
English: Pharmacodynamic effects 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: Cases of agranulocytosis, thrombocytopenia, leucopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Danish: Der er rapporteret tilfælde med agranulocytose, trombocytopeni, leukopeni, aplastisk anæmi, pancytopeni og leukocytose.
English: If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing zonisamide (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 zonisamid (ved gradvis dosisreduktion), da der kan udvikles osteopeni.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome
Danish: Grand mal anfald Myasthenisk syndrom Malignt neuroleptikumsyndrom Status epilepticus
English: Renal clearance of single doses of zonisamide was positively correlated with creatinine clearance.
Danish: Renal clearance af enkeltdoser af zonisamid var positivt korreleret med creatininclearance.
English: Zonisamide may cause weight loss.
Danish: Zonisamid kan forårsage vægttab.
English: If substantial undesirable weight loss occurs, discontinuation of zonisamide should be considered.
Danish: Hvis der opstår et betydeligt uønsket vægttab, bør seponering af zonisamid overvejes.
English: You might also feel sick, have a sore stomach, muscle twitches, eye movement, feel faint, have a slowed heartbeat, 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: Consideration must be given to discontinuing zonisamide in patients who develop an otherwise unexplained rash.
Danish: Seponering af zonisamid bør overvejes hos patienter, som udvikler et i øvrigt uforklarligt udslæt.
English: The adverse event profile of zonisamide in paediatric patients aged 6 to 17 years in placebo-controlled clinical studies was consistent with that of adults.
Danish: Zonisamids bivirkningsprofil hos pædiatriske patienter i alderen 6 til 17 år var i placebo-kontrollerede kliniske studier i overensstemmelse med bivirkningsprofilen hos voksne.
English: Adults - recommended dosage escalation and maintenance regimen
Danish: Voksne - anbefalinger for dosisøgning og vedligeholdelsesbehandling
English: • The child should stay cool especially in hot weather
Danish: • Barnet skal have det køligt, navnlig i varmt vejr
English: Mylan S.A.S 117 allee des Parcs, 69 800 Saint Priest, France
Danish: Mylan S.A.S 117 allee des Parcs, 69-800 Saint Priest Frankrig
English: 117 Allee des Parcs, 69 800 Saint Priest, France
Danish: 117 Allee des Parcs, 69-800 Saint Priest, Frankrig
English: It should be noted that zonisamide is a benzisoxazole derivative, which contains a sulfonamide group.
Danish: Det skal bemærkes, at zonisamid er et benzisoxazolderivat, som indeholder en sulfonamidgruppe.
English: There are insufficient data for the withdrawal of concomitant antiepileptic medicines once seizure control with zonisamide has been achieved in the add-on situation, in order to reach monotherapy with zonisamide.
Danish: Der er utilstrækkelige data vedrørende seponering af ledsagende antiepileptika, straks der er opnået kontrol over anfaldene med zonisamid i suppleringssituationen, for at nå frem til monoterapi med zonisamid.
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, især dem som er disponeret for nephrolithiasis, kan have en øget risiko for nyrestensdannelse og dermed forbundne tegn og symptomer såsom nyrekolik eller nyre- eller flankesmerter.