FrancophonIA/ELRC3.0 huggingface dataset:
English: Among 465 subjects in the paediatric safety database (including a further 67 subjects from the extension phase of the controlled clinical trial) there were 7 deaths (1.5%; 14.6/1000 person-years): 2 cases of status epilepticus, of which one was related to severe weight loss (10% within 3 months) in an underweight subject and subsequent failure to take medication; 1 case of head injury/haematoma, and 4 deaths in subjects with pre-existing functional neurological deficits for various causes (2 cases of pneumonia-induced sepsis/organ failure, 1 SUDEP and 1 head injury).
Danish: yderligere 67 patienter fra det kontrollerede kliniske studies forlængelsesfase) var der 7 dødsfald (1,5 %; 14,6/1.000 personår): 2 tilfælde af status epilepticus, hvoraf den ene var forbundet med kraftigt vægttab (10 % i løbet af 3 måneder) hos en undervægtig person og efterfølgende undladelse af at tage medicin, 1 tilfælde af hovedtraume/hæmatom og 4 dødsfald hos patienter med eksisterende svigt i neurologisk funktion af forskellige årsager (2 tilfælde af pneumoni-induceret sepsis/organsvigt, 1 tilfælde af pludselig og uventet død ved epilepsi og 1 hovedtraume).
English: Therefore use in patients with severe hepatic impairment is not recommended.
Danish: Derfor anbefales brugen ikke til patienter med svært nedsat leverfunktion.
English: 28 hard capsules 56 hard capsules 98 hard capsules 196 hard capsules
Danish: Blisterpakninger: 28 hårde kapsler 56 hårde kapsler 98 hårde kapsler 196 hårde kapsler
English: Caution should be used when treating patients with history of eye disorders with zonisamide.
Danish: Der skal udvises forsigtighed ved behandling af patienter, som har en historik med øjensygdomme, med zonisamid.
English: Changes in renal histopathology and clinical pathology parameters were considered to be related to carbonic anhydrase inhibition by zonisamide.
Danish: Det blev skønnet, at ændringer i renal histopatologi og kliniske patologiparametre var forbundet med zonisamids kulsyreanhydrasehæmning.
English: A pooled analysis of safety data on 420 paediatric subjects (183 subjects aged 6 to 11 years, and 237 subjects aged 12 to 16 years with a mean duration of exposure of approximately 12 months) has shown a relatively higher reporting frequency of pneumonia, dehydration, decreased sweating, abnormal liver function tests, otitis media, pharyngitis, sinusitis and upper respiratory tract infection, cough, epistaxis and rhinitis, abdominal pain, vomiting, rash and eczema, and fever compared to the adult population (particularly in subjects aged below 12 years) and, at a low incidence, amnesia, creatinine increased, lymphadenopathy, and thrombocytopenia.
Danish: En samlet analyse af sikkerhedsdata for 420 pædiatriske patienter (183 patienter i alderen 6 til 11 år og 237 patienter i alderen 12 til 16 år med en gennemsnitlig eksponeringsvarighed på ca. 12 måneder) har vist en forholdsvis højere indberetningshyppighed af pneumoni, dehydrering, nedsat svedproduktion, unormale leverfunktionsprøver, otitis media, faryngitis, sinuitis og infektion i de øvre luftveje, hoste, epistaxis og rhinitis, abdominalsmerter, opkastning, udslæt og eksem samt feber i forhold til den voksne population (navnlig hos patienter under 12 år) og en lav forekomst af amnesi, forhøjet kreatinin, lymfadenopati og trombocytopeni.
English: Prescribers should draw the attention of paediatric patients and their parent/carers to the advice in the Packaging Leaflet on preventing heat stroke and overheating in children as provided.
Danish: Ordinerende læger skal gøre pædiatriske patienter og deres forælder/omsorgsgivere opmærksomme på rådene i indlægssedlen om forebyggelse af hedeslag og overophedning hos børn.
English: Hypokalaemia Metabolic acidosis Renal tubular acidosis
Danish: Metabolisk acidose Renal tubulær acidose
English: The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in paediatric and adolescent patients.
Danish: Risikoen for zonisamidinduceret metabolisk acidose synes at være hyppigere og mere alvorlig hos pædiatriske og unge patienter.
English: Capsule contents Microcrystalline cellulose Sodium laurilsulfate Hydrogenated vegetable oil
Danish: Mikrokrystallinsk cellulose Natriumlaurilsulfat Hydrogeneret vegetabilsk olie
English: The warnings and precautions mentioned above are also applicable to adolescent and paediatric patients.
Danish: De advarsler og sikkerhedsforskrifter, der er nævnt herover, gælder også for unge og børn.
English: - This may be increased by 1 mg per kg of body weight at intervals of one to two weeks.
Danish: • Denne dosis kan øges med 1 mg pr. kg legemsvægt med intervaller på 1 - 2 uger.
English: Zonisamide is a benzisoxazole derivative.
Danish: Zonisamid er et benzisoxazolderivat.
English: Therefore, modification of zonisamide dosing should not be necessary when co-administered with known CYP3A4 inhibitors.
Danish: Ændring af zonisamid-dosis skulle derfor ikke være nødvendig, når det gives samtidigt med kendte CYP3A4-hæmmere.
English: Zonisamide must not be used in women of childbearing potential not using effective contraception unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus.
Danish: Zonisamid må ikke bruges hos kvinder i den fertile alder, som ikke anvender sikker kontraception, medmindre det er klart nødvendigt, og kun hvis den potentielle fordel anses for at opveje risikoen for fosteret.
English: The pharmacokinetics of zonisamide in patients with impaired liver function have not been adequately studied.
Danish: Nedsat leverfunktion: Zonisamids farmakokinetik hos patienter med nedsat leverfunktion er ikke undersøgt tilstrækkeligt.
English: Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg: - The starting dose is 1 mg per kg of body weight taken once a day.
Danish: Brug til børn (i alderen 6 - 11 år) og unge (i alderen 12 - 17 år), som vejer mindst 20 kg:
English: Enzyme induction: Exposure to zonisamide is lower in epileptic patients receiving CYP3A4-inducing agents such as phenytoin, carbamazepine, and phenobarbitone.
Danish: - Enzyminduktion: Ekspositionen for zonisamid er mindre hos epilepsipatienter, der får CYP3A4induktorer så som phenytoin, carbamazepin og phenobarbital.
English: In the event of signs or symptoms of dehydration, oligohydrosis, or elevated body temperature, discontinuation of zonisamide should be considered.
Danish: Ved tegn og symptomer på dehydrering, nedsat svedtendens eller forhøjet legemstemperatur skal det overvejes at seponere zonisamid.
English: If pancreatitis is evident, in the absence of another obvious cause, it is recommended that discontinuation of zonisamide be considered and appropriate treatment initiated.
Danish: Hvis det er klart, at det drejer sig om pancreatitis uden anden nærliggende årsag, anbefales det at overveje at seponere zonisamid og påbegynde passende behandling.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om Zonisamide Mylan, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Caution must be exercised in treating patients with mild to moderate hepatic impairment, and a slower titration of Zonisamide Mylan may be required.
Danish: Der skal udvises forsigtighed ved behandling af patienter med let til moderat nedsat leverfunktion og det kan være nødvendigt med en langsommere titrering af Zonisamide Mylan.
English: In patients taking zonisamide, in whom severe muscle pain and/or weakness develop either in the presence or absence of a fever, it is recommended that markers of muscle damage be assessed, including serum creatine phosphokinase and aldolase levels.
Danish: Hos patienter, der tager zonisamid, hvor der udvikles alvorlige muskelsmerter/eller svaghed enten med eller uden feber, anbefales det, at kontrollere markører for muskelskade herunder creatinfosfokinase og aldolase koncentrationen i serum.
English: Most adverse effects observed in the juvenile rats were similar to those seen in the repeated-dose toxicity studies of zonisamide in adult rats, but renal tubular hyaline droplets and transitional hyperplasia were observed in the juvenile study only.
Danish: De fleste bivirkninger, der sås hos unge rotter, svarede til dem, der sås i toksicitetsstudier med gentagne zonisamiddoser til voksne rotter, men renale tubulære hyalindråber og forbigående hyperplasi blev kun set hos unge rotter.
English: - This may be increased by up to 100 mg at intervals of two weeks.
Danish: • Dette kan øges med op til 100 mg med to ugers intervaller.
English: Drug-induced hypersensitivity syndrome Drug rash with eosinophilia and systemic symptoms
Danish: Lægemiddelinduceret overfølsomhedssyndrom Lægemiddeludslæt med eosinofili og systemiske symptomer
English: Caution must be exercised in treating patients with renal impairment, as there is limited information on use in such patients and a slower titration of Zonisamide Mylan might be required.
Danish: Der skal udvises forsigtighed ved behandling af patienter med nedsat nyrefunktion, da der er begrænsede oplysninger om brugen til sådanne patienter og en langsommere titrering af Zonisamide Mylan kan være påkrævet.
English: Zonisamide caused developmental abnormalities in mice, rats, and dogs, and was embryolethal in monkeys, when administered during the period of organogenesis at zonisamide dosage and maternal plasma levels similar to or lower than therapeutic levels in humans.
Danish: Zonisamid medførte udviklingsabnormiteter hos mus, rotter og hunde og var dødeligt for fosteret hos aber ved zonisamiddosering og plasmakoncentrationer hos moderen svarende til eller lavere end den terapeutiske koncentration hos mennesker, når det blev indgivet i perioden, hvor organerne anlægges.
English: Therefore, zonisamide is not expected to affect the pharmacokinetics of other medicinal products via cytochrome P450-mediated mechanisms, as demonstrated for carbamazepine, phenytoin, ethinylestradiol and desipramine in vivo.
Danish: Det forventes derfor ikke, at zonisamid påvirker farmakokinetikken af andre lægemidler via CYPmediere mekanismer, som det er vist for carbamazepin, phenytoin, ethinylestradiol og desipramin in-vivo.
English: • monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy (see section 5.1);
Danish: • monoterapi til behandling af partielle anfald med eller uden sekundær generalisering hos voksne med nydiagnosticeret epilepsi (se pkt.
English: Studies in animals have shown changes in fertility parameters (see section 5.3).
Danish: Dyrestudier har påvist ændringer i visse fertilitetsparametre (se pkt.
English: Do not take Zonisamide Mylan - if you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for zonisamid eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).
Danish: Lægen holder øje med indholdet af hydrogencarbonat i barnets blod og med barnets nyrer (se også punkt 4).
English: The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min (see also section 4.2.
Danish: Plasma AUC for zonisamid blev øget med 35 % hos patienter med creatininclearance < 20 ml/min (se også pkt.
English: • The child must not take any of these medicines: carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
Danish: • Barnet må ikke tage nogen af følgende lægemidler: kulsyreanhydrasehæmmere (såsom topiramat og acetazolamid) og antikolinergika (såsom clomipramin, hydroxyzin, diphenhydramin, haloperidol, imipramin og oxybutynin).
English: Nevertheless, if a hepatic event is suspected, liver function should be evaluated and discontinuation of zonisamide should be considered.
Danish: Ved mistanke om en leverrelateret bivirkning skal leverfunktionen ikke desto mindre evalueres og seponering af zonisamid overvejes.
English: Treatment Regimen
Danish: Behandlingsprogram
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: 500 mg for et barn, som vejer mere end 55 kg (den laveste dosis).
English: Iron oxide Red (E172)
Danish: Rød jernoxid (E172)
English: • adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.
Danish: • supplerende terapi til behandling af partielle anfald med eller uden sekundær generalisering hos voksne, unge og børn på 6 år og derover.
English: Zonisamide Mylan can make you perspire less, which can cause your body temperature to increase.
Danish: Zonisamidee Mylan kan betyde, at De sveder mindre, så Deres legemstemperatur eventuelt kan stige.
English: The most common adverse reactions in a randomised, controlled monotherapy trial comparing zonisamide with carbamazepine prolonged release were decreased bicarbonate, decreased appetite, and decreased weight.
Danish: De hyppigste bivirkninger i et randomiseret, kontrolleret studie med monoterapi, der sammenlignede zonisamid med carbamazepin-depotformulering, var nedsat hydrogencarbonat, nedsat appetit og vægttab.
English: Physicians should draw the attention of paediatric patients and their parents/carers to the Patient Alert Box (in the package leaflet) on preventing heat stroke (see section 4.4: Paediatric Population).
Danish: Læger skal gøre pædiatriske patienter og deres forældre/omsorgsgivere opmærksom på boksen Patientadvarsel (i indlægssedlen) om forebyggelse af hedeslag (se pkt.
English: 300 to 500 mg per day (once a day or two divided doses).
Danish: 300 til 500 mg dagligt (én gang dagligt eller fordelt på 2 doser).
English: Use in patients with hepatic impairment has not been studied.
Danish: Anvendelse til patienter med nedsat leverfunktion er ikke undersøgt.
English: Cognition
Danish: Kognition
English: Bradyphrenia Disturbance in attention Nystagmus Paraesthesia Speech disorder Tremor
Danish: Bradyfreni Forstyrrelse af opmærksomhed Nystagmus Paræstesi Taleforstyrrelser Tremor
English: If the decision is made to continue patients on zonisamide in the face of persistent acidosis, alkali treatment should be considered.
Danish: Hvis det på trods af persisterende acidose besluttes at fortsætte behandlingen med zonisamid, skal alkaliserende behandling overvejes.
English: Renal ultrasound should be performed at the discretion of the physician.
Danish: Ultralydsskanning af nyrerne skal foretages efter lægens skøn.
English: Ophthalmologic findings can include myopia, anterior chamber shallowing, and ocular hyperaemia (redness) and increased intraocular pressure.
Danish: Oftalmologiske symptomer kan omfatte myopi, hulning af forreste øjenkammer, okulær hyperæmi (rødme) og øget tryk i øjet.
English: Subjects were titrated to the initial target dose of 600 mg carbamazepine or 300 mg of zonisamide.
Danish: Personerne blev titreret til den initiale måldosis på 600 mg carbamazepin eller 300 mg zonisamid.
English: Subjects who experienced a seizure were titrated to the next target dose i.e. 800 mg carbamazepine or 400 mg of zonisamide.
Danish: Personer, som fik et anfald, blev titreret til den næste måldosis, dvs. 800 mg carbamazepin eller 400 mg zonisamid.
English: Zonisamide is a benzisoxazole derivative, which contains a sulfonamide group.
Danish: Zonisamid er et benzisoxazolderivat, som indeholder en sulfonamid gruppe.
English: In epileptic patients, steady-state dosing with zonisamide resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Danish: Hos epilepsipatienter resulterede ligevægtsdosering med zonisamid ikke i klinisk relevante farmakokinetiske virkninger på carbamazepin, lamotrigin, phenytoin eller natriumvalproat.
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,
English: - Do not chew the capsules.
Danish: • Kapslerne må ikke tygges.
English: blurred vision or decreased vision may occur and can be signs of glaucoma.
Danish: Smerter i øjet, sløret syn eller nedsat syn kan opstå og kan være tegn på glaukom.
English: The other ingredients are: - capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate - capsule shell: gelatin and titanium dioxide (E171) - printing ink: shellac and iron oxide red (E172)
Danish: Øvrige indholdsstoffer: - indhold i kapslen: mikrokrystallinsk cellulose, hydrogeneret vegetabilsk olie og natriumlaurilsulfat - indhold kapselskallen: gelatine, titandioxid (E171) - prægeblæk indeholder: shellac og rød jernoxid (E172).
English: Paediatric population (aged 6 years and above) - recommended down-titration schedule Weight
Danish: Pædiatrisk population (på 6 år og derover) - anbefalet nedtitreringsskema
English: Paediatric population (aged 6 years and above) - recommended dosage escalation and maintenance regimen Treatment Regimen
Danish: Pædiatrisk population (6 år og derover) - anbefalet dosisøgning og vedligeholdelsesbehandling
English: The skin feels very hot with little or no sweating, or the child becomes confused or has muscle cramps, or the child's heartbeat or breathing become rapid.
Danish: Huden føles meget varm, og barnet ikke sveder eller kun sveder lidt, hvis barnet bliver forvirret, hvis barnet har muskelkramper, eller hvis barnet får hurtig puls eller hurtigt åndedræt.
English: Zonisamide Mylan is indicated as:
Danish: Zonisamide Mylan er indiceret som:
English: The warnings and precautions mentioned below are more relevant to paediatric and adolescent patients.
Danish: De advarsler og sikkerhedsforskrifter, der er nævnt herunder, er mest relevante for børn og unge.
English: Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulfamoylacetylphenol (SMAP) and also by N-acetylation.
Danish: Zonisamid metaboliseres primært af CYP3A4 via en reduktiv spaltning af benzisoxazolringen i moderstoffet, så der dannes 2-sulphamoylacetylphenol (SMAP) samt også ved N acetylering.
English: What Zonisamide Mylan contains:
Danish: Zonisamide Mylan indeholder:
English: Each hard capsule is approximately 15.8 mm in length.
Danish: Hver hård kapsel er ca. 15,8 mm lang.
English: Zonisamide Mylan may be used:
Danish: Zonisamide Mylan kan anvendes:
English: 14 hard capsules 28 hard capsules 56 hard capsules
Danish: Blisterpakninger: 14 hårde kapsler 28 hårde kapsler 56 hårde kapsler
English: Pneumonia aspiration Respiratory disorder Hypersensitivity-type Pneumonitis
Danish: Aspirationspneumoni Respirations-problemer Pneumonitis af overfølsomhedstypen
English: Urine analysis abnormal
Danish: Unormale urinanalyser
English: Hyperchloraemic, non-anion gap, metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with zonisamide treatment.
Danish: Zonisamidbehandling er forbundet med hyperkloræmisk, non-aniongap, metabolisk acidose (dvs. nedsat hydrogencarbonat under det normale referenceinterval i fravær af kronisk respiratorisk alkalose).
English: The incidence of decreased body weight is consistent across age groups (see section 4.8); however, given the potential seriousness of weight loss in children, weight should be monitored in this population.
Danish: 4.8), men i betragtning af hvor alvorligt vægttab kan være hos børn, bør vægten monitoreres hos denne population.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Zonisamide Mylan 100 mg are available in blister packs of 28, 56, 98 and 196 capsules and perforated unit dose blister packs of 56 x 1 capsules.
Danish: Zonisamide Mylan 100 mg fås i blisterpakninger med 28, 56, 98 eller 196 kapsler, og i perforerede blisterpakninger, der indeholder 56 × 1 kapsler.
English: A very high plasma concentration of 100.1 μg/ml zonisamide was recorded approximately 31 hours after a patient took an overdose of zonisamide and clonazepam; the patient became comatose and had respiratory depression, but recovered consciousness five days later and had no sequelae.
Danish: En meget høj plasmakoncentration på 100,1 µg/ml zonisamid blev registreret ca. 31 timer efter, at en patient tog en overdosis af zonisamid og clonazepam.
English: In children ages 6 - 17 years old, side effects were consistent with those described below with the following exceptions: pneumonia, dehydration, sweating decreased (common), abnormal liver enzymes (uncommon), middle ear infection, sore throat, sinus and chest infections, cough, nosebleeds, runny nose, stomach pain, vomiting, rash, eczema and fever.
Danish: Hos børn i alderen 6 - 17 år var bivirkningerne de samme som beskrevet herunder, dog med følgende undtagelser: lungebetændelse, væskemangel (dehydrering), nedsat svedproduktion (almindelig) og unormale prøver for leverfunktion (ikke almindelig), mellemørebetændelse, ondt i halsen, bihule- eller lungebetændelse, hose, næseblod, dryppende næse, mavepine, opkast, kløe, eksem og feber.
English: Nephrolithiasis Calculus urinary Hydronephrosis Renal failure
Danish: Nephrolithiasis Sten i urinvejene Hydronephrose Nyresvigt
English: If you are a woman of childbearing age you must use adequate contraception while taking, and for one month after stopping, Zonisamide Mylan.
Danish: Hvis De er kvinde i den fødedygtige alder, skal De anvende passende svangerskabsforebyggelse, mens De tager Zonisamide Mylan og i en måned efter, De er holdt op med Zonisamide Mylan.
English: MonotherapyNewly diagnosed adult patients
Danish: MonoterapiNydiagnosticerede voksne patienter
English: Zonisamide is excreted in human milk; the concentration in breast milk is similar to maternal plasma.
Danish: Koncentrationen i modermælk er den samme som i moderens plasma.
English: Nystagmus Speech disorder Tremor
Danish: Nystagmus Talebesvær Tremor Krampeanfald
English: Dosage escalation and maintenance
Danish: Dosistitrering og vedligeholdelsesdosis
English: The other ingredients are: - capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate - capsule shell: gelatin and titanium dioxide (E171) - printing ink: shellac, black iron oxide (E172) and potassium hydroxide.
Danish: Øvrige indholdsstoffer: - indhold i kapslen: mikrokrystallinsk cellulose, hydrogeneret vegetabilsk olie og natriumlaurilsulfat - indhold kapselskallen: gelatine, titandioxid (E171) - prægeblæk indeholder: shellac, sort jernoxid (E172) og kaliumhydroxid.
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients (see section 4.4 Paediatric Population for full warning).
Danish: Tilfælde med nedsat svedproduktion og forhøjet legemstemperatur er blevet rapporteret hovedsagelig hos pædiatriske patienter (se den fuldstændige advarsel i pkt.
English: Physicians should discuss with patients and their carers the potential seriousness of heat stroke, situations in which it might arise, as well as action to take in the event of any signs or symptoms.
Danish: Læger skal drøfte, hvor alvorligt hedeslag kan være, i hvilke situationer det kan forekomme, samt hvilke handlinger der skal træffes i tilfælde af tegn eller symptomer, med patienterne og deres omsorgsgivere.