FrancophonIA/ELRC3.0 huggingface dataset:
English: • loss of appetite, decreased blood levels of bicarbonate (a substance that prevents your blood from becoming acidic)
Danish: • appetitløshed, nedsat indhold af hydrogencarbonat i blodet (et stof, der forhindrer at blodet bliver surt)
English: Cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Danish: Der er rapporteret tilfælde med agranulocytose, trombocytopeni, leukopeni, aplastisk anæmi, pancytopeni og leukocytose.
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) and abnormal liver enzymes (uncommon).
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).
English: When Zonegran treatment is to be discontinued, it should be withdrawn gradually (see section 4.4).
Danish: Når Zonegran seponeres, bør det ske gradvist (se pkt.
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: Consideration must be given to discontinuing Zonegran in patients who develop an otherwise unexplained rash.
Danish: Seponering af Zonegran bør overvejes hos patienter, som udvikler et i øvrigt uforklarligt udslæt.
English: In patients taking Zonegran, 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 Zonegran, hvor der udvikles alvorlige muskelsmerter/eller svaghed enten med eller uden feber, anbefales det, at kontrollere markører for muskelskade herunder niveauerne af creatinfosfokinase og aldolase i serum.
English: Week 1 + 2 Week 3 + 4 Week 5 + 6
Danish: Uge 1 + 2 Uge 3 + 4
English: The warnings and precautions mentioned below are more relevant to paediatric and adolescent patients.
Danish: De advarsler og forsigtighedsregler, der er nævnt herunder, er mest relevante for pædiatriske og unge patienter.
English: Zonegran contains the active substance zonisamide, and is used as an antiepileptic medicine.
Danish: Zonegran indeholder det aktive stof zonisamid og anvendes mod epilepsi (et antiepileptikum).
English: Zonegran contains Hydrogenated vegetable oil (from soyabean).
Danish: Zonegran indeholder hydrogeneret vegetabilsk olie (fra soja).
English: Monotherapy in partial seizures, with or without secondary generalisation
Danish: Monoterapi til partielle anfald med eller uden sekundær generalisering
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 uforklarlig død ved epilepsi og 1 hovedtraume).
English: If you stop taking Zonegran
Danish: Hvis De holder op med at tage Zonegran
English: Studies in animals have shown changes in fertility parameters (see section 5.3).
Danish: Dyrestudier har påvist ændringer i fertilitetsparametre (se pkt.
English: In epileptic patients, steady-state dosing with Zonegran resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Danish: Hos epilepsipatienter resulterede steady-state-dosering med Zonegran ikke i klinisk relevante farmakokinetiske virkninger på carbamazepin, lamotrigin, phenytoin eller natriumvalproat.
English: Therefore, Zonegran 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 Zonegran påvirker farmakokinetikken af andre lægemidler via CYPmedierede mekanismer, som det er vist for carbamazepin, phenytoin, ethinylestradiol og desipramin in vivo.
English: If pancreatitis is evident, in the absence of another obvious cause, it is recommended that discontinuation of Zonegran 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 Zonegran og påbegynde passende behandling.
English: Acute myopia and secondary angle closure glaucoma
Danish: Akut myopi og sekundært lukket-vinkel glaukom
English: Zonegran 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: Zonegran 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: Ataxia Dizziness Memory impairment Somnolence
Danish: Ataksi Svimmelhed Hukommelsesbesvær Døsighed
English: • vomiting.
Danish: • opkastning.
English: Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: Titanium dioxide (E171) Allura red AC (E129) Sunset yellow FCF (E110) Shellac
Danish: Titandioxid (E171) Allura red AC (E129) Sunset yellow FCF (E110) Shellac
English: Patients must not take this medicinal product if they are allergic to peanut or soya.
Danish: De må ikke bruge denne medicin, hvis De er allergisk over for jordnødder eller soja.
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 mest almindelige bivirkninger i et randomiseret, kontrolleret studie med monoterapi, der sammenlignede zonisamid med carbamazepin-depotformulering, var nedsat hydrogencarbonat, nedsat appetit og vægttab.
English: • The recommended dose is 300 mg once a day.
Danish: • Den anbefalede dosis er 300 mg én gang dagligt.
English: What Zonegran contains The active substance in Zonegran is zonisamide.
Danish: Zonegran indeholder: Aktivt stof i Zonegran: zonisamid.
English: Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Danish: Zonegran er et benzisoxazolderivat, som indeholder en sulfonamidgruppe.
English: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany
Danish: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Tyskland
English: Physicians should draw the attention of paediatric patients and their parents/carers to the Patient Alert Box (in the package leaflet) on preventing heatstroke (see section 4.4: Paediatric population).
Danish: Læger skal gøre pædiatriske patienter og deres forældre/omsorgsgivere opmærksomme på boksen med patientadvarsler (i indlægssedlen) om forebyggelse af hedeslag (se pkt.
English: Nevertheless, if a hepatic event is suspected, liver function should be evaluated and discontinuation of Zonegran should be considered.
Danish: Ved mistanke om en leverrelateret bivirkning skal leverfunktionen ikke desto mindre evalueres og seponering af Zonegran overvejes.
English: If you forget to take Zonegran
Danish: Hvis De har glemt at tage Zonegran
English: Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome
Danish: Grand mal-anfald Myasthenisk syndrom
English: • skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss.
Danish: • hududslæt, kløe, allergiske reaktioner, feber, træthed, influenzalignende symptomer, hårtab.
English: In subjects with renal impairment, renal clearance of single doses of zonisamide was positively correlated with creatinine clearance.
Danish: Hos patienter med nedsat nyrefunktion var den renale clearance af enkeltdoser af zonisamid positivt korreleret med creatininclearance.
English: When your child is taking Zonegran:
Danish: Når barnet tager Zonegran:
English: Caution should be used when treating patients with history of eye disorders with zonisamide.
Danish: Der bør udvises forsigtighed, når patienter med tidligere øjensygdomme behandles med zonisamid.
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 Zonegran 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 Zonegran kan være påkrævet.
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 Zonegran treatment.
Danish: Zonegranbehandling er forbundet med hyperkloræmisk, non-aniongap, metabolisk acidose (dvs. nedsat hydrogencarbonat i serum under det normale referenceinterval i fravær af kronisk respiratorisk alkalose).
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 personer under 12 år) og en lav forekomst af amnesi, forhøjet kreatinin, lymfadenopati og trombocytopeni.
English: There are insufficient data for the withdrawal of concomitant antiepileptic medicines once seizure control with Zonegran has been achieved in the add-on situation, in order to reach monotherapy with Zonegran.
Danish: Der er utilstrækkelige data vedrørende seponering af ledsagende antiepileptika, efter der er opnået kontrol over anfaldene med Zonegran i suppleringssituationen, for at nå frem til monoterapi med Zonegran.
English: Women planning a pregnancy should meet with their specialists to reassess treatment with Zonegran and to consider other therapeutic options.
Danish: Kvinder, der planlægger at blive gravide, skal konsultere deres specialister med henblik på genvurdering af behandlingen med Zonegran og for at overveje andre behandlingsmuligheder.
English: Caution must be exercised in treating patients with mild to moderate hepatic impairment, and a slower titration of Zonegran 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 Zonegran.
English: • With other antiepileptic medicines to treat seizures in adults, adolescents, and children aged
Danish: • Sammen med andre antiepileptika til behandling af anfald hos voksne, unge og børn på 6 år og derover.
English: • The starting dose is 1 mg per kg of body weight taken once a day.
Danish: • Startdosis er 1 mg pr. kg legemsvægt én gang dagligt.
English: Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population) Six months seizure freedom
Danish: Tabel 6 Resultater for virkning i monoterapistudie 310 Zonisamid Carbamazepin n (ITT-population) Seks måneder uden anfald
English: Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulphamoylacetylphenol (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: • 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 lægemidler med antikolinerg virkning (såsom clomipramin, hydroxyzin, diphenhydramin, haloperidol, imipramin og oxybutynin).
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: If you are a woman of childbearing age you must use adequate contraception while taking and for one month after stopping Zonegran.
Danish: Hvis De er kvinde i den fødedygtige alder, skal De anvende tilstrækkelig svangerskabsforebyggelse, mens De tager Zonegran og i en måned efter, De er holdt op med Zonegran.
English: Ophthalmologic findings can include myopia, anterior chamber shallowing, and ocular hyperaemia (redness) and increased intraocular pressure.
Danish: Oftalmologiske fund kan omfatte myopi, forsnævring af øjets forkammer og okulær hyperæmi (rødme) og øget intraokulært tryk.
English: Propylene glycol Potassium hydroxide Black iron oxide (E172)
Danish: Propylenglycol Kaliumhydroxid Sort jernoxid (E172)
English: Vision blurred Visual acuity reduced
Danish: Sløret syn Nedsat synsskarphed
English: What you need to know before you take Zonegran
Danish: Det skal De vide, før De begynder at tage Zonegran
English: • Give your child cold water to drink
Danish: • Giv barnet koldt vand at drikke
English: Examples include: sulphonamide antibiotics,
Danish: Eksempler herpå er: sulfonamid antibiotika, thiaziddiuretika og sulfonylurinstof-antidiabetika.
English: • lung infection / inflammation, urinary tract infections.
Danish: • infektion i lungerne/lungebetændelse, urinvejsinfektioner.
English: A very high plasma concentration of 100.1 μg/ml zonisamide was recorded approximately 31 hours after a patient took an overdose of Zonegran 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 Zonegran og clonazepam.
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: Agitation Irritability Confusional state
Danish: Agitation Irritabilitet Konfusionstilstande Depression
English: • have signs of increased acid level in the blood- headaches, drowsiness, shortness of breath and loss of appetite.
Danish: • har tegn på forhøjet syreniveau i blodet: hovedpine, døsighed, kortåndethed og appetitløshed.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zonegran therapy.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Zonegran seponeres.
English: Specialist medical advice should be given to women treated with zonisamide who are of childbearing potential.
Danish: Der bør gives medicinsk specialistrådgivning til kvinder i den fertile alder, der behandles med zonisamid.
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 sveder ikke eller sveder kun lidt, hvis barnet bliver forvirret, hvis barnet har muskelkramper, eller hvis barnet får hurtig puls eller hurtigt åndedræt.
English: • Take your child to a cool, shaded place
Danish: • Barnet skal flyttes til et køligt sted i skyggen
English: If the decision is made to continue patients on Zonegran in the face of persistent acidosis, alkali treatment should be considered.
Danish: Hvis det på trods af persisterende acidose besluttes at fortsætte behandlingen med Zonegran, skal alkaliserende behandling overvejes.
English: If your child's skin feels very hot with little or no sweating, becomes confused, has muscle cramps, or your child's heartbeat or breathing becomes rapid:
Danish: Hvis barnets hud føles meget varm, og barnet ikke sveder eller kun sveder lidt, bliver forvirret, har muskelkramper, får hurtig puls eller hurtigt åndedræt:
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: • are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumonia and liver problems.
Danish: • De er yngre end 12 år, da De kan have en større risiko for nedsat svedproduktion, hedeslag,
English: • slowed thoughts, loss of concentration, speech abnormalities, abnormal skin sensation (pins and needles), tremor, involuntary movement of the eyes.
Danish: • langsomme tanker, tab af koncentrationsevne, taleforstyrrelser, unormal følelse i huden (sovende fornemmelse), rystelser, ufrivillige øjenbevægelser.
English: Paediatric population (aged 6 years and above) - recommended dosage escalation and maintenance regimen
Danish: Tabel 2 Pædiatrisk population (6 år og derover) - anbefalet dosistitrering og vedligeholdelsesbehandling Behandlingsprogram Titreringsfase
English: Hydrogenated vegetable oil (from soyabean)
Danish: Hydrogeneret vegetabilsk olie (fra soja)
English: Excipients: 0.002 mg of sunset yellow FCF (E110) and 0.147 mg of allura red AC (E129).
Danish: Hjælpestoffer: 0,002 mg sunset yellow FCF (E110) og 0,147 mg allura red AC (E129).
English: Do not take Zonegran: • if you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section
Danish: • hvis De er allergisk over for zonisamid eller et af de øvrige indholdsstoffer i Zonegran (angivet i punkt 6).
English: These effects are unlikely to be of clinical significance when Zonegran is added to existing therapy; however, changes in zonisamide concentrations may occur if concomitant CYP3A4-inducing anti-epileptic or other medicinal products are withdrawn, dose adjusted or introduced, an adjustment of the Zonegran dose may be required.
Danish: Ændringer i zonisamidkoncentrationen kan dog forekomme, hvis samtidig behandling med et CYP3A4-inducerende antiepileptikum eller andre lægemidler seponeres, hvor dosis justeres eller påbegyndes og justering af Zonegrandosis kan blive nødvendig.
English: Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescent and paediatric patients (aged 6 years and above)
Danish: Supplerende terapi til behandling af partielle anfald med eller uden sekundær generalisering hos unge og pædiatriske patienter (6 år og derover)
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: Adverse reactions in a randomised, controlled monotherapy trial comparing zonisamide with carbamazepine prolonged release System Organ Class (MedDRA terminology†)
Danish: Tabel 5 Bivirkninger i et randomiseret, kontrolleret studie med monoterapi, der sammenlignede zonisamid med carbamazepin-depotformulering Systemorganklasser (MedDRA-terminologi†)
English: • suffer from liver problems, as your dose of Zonegran may need adjusting.
Danish: • De har leverproblemer, fordi det kan være nødvendigt at justere Deres dosis af Zonegran.
English: Drug-induced hypersensitivity syndrome Drug rash with eosinophilia and systemic symptoms
Danish: Lægemiddeludslæt med eosinofili og systemiske symptomer
English: Erythema multiforme Stevens-Johnson syndrome Toxic epidermal necrolysis
Danish: Erythema multiforme Stevens-Johnsons syndrom
English: Adults - recommended dosage escalation and maintenance regimen
Danish: Tabel 1 Voksne - anbefalinger for dosisøgning og vedligeholdelsesbehandling Behandlingsprogram
English: Other medicines and Zonegran
Danish: Brug af anden medicin sammen med Zonegran
English: Zonegran should be used with caution in adult patients treated concomitantly with carbonic anhydrase inhibitors such as topiramate and acetazolamide, as there are insufficient data to rule out a possible pharmacodynamic interaction (see section 4.4).
Danish: Zonegran bør anvendes med forsigtighed hos voksne patienter, der samtidig behandles med kulsyreanhydrasehæmmere såsom topiramat og acetazolamid, da der foreligger utilstrækkelige data til at udelukke en mulig farmakodynamisk interaktion (se pkt.
English: Microcrystalline cellulose Hydrogenated vegetable oil (from soyabean) Sodium laurilsulfate
Danish: Mikrokrystallinsk cellulose Hydrogeneret vegetabilsk olie (fra soja) Natriumlaurilsulfat
English: • loss of weight, nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation.
Danish: • vægttab, kvalme, fordøjelsesbesvær, mavesmerter, diaré (løs afføring), forstoppelse.
English: Adverse reactions associated with Zonegran obtained from clinical studies and post-marketing surveillance are tabulated below.
Danish: Bivirkninger forbundet med Zonegran registreret fra kliniske studier og overvågning efter markedsføring er anført i nedenstående tabel.
English: Adjunctive therapy - with CYP3A4inducing agents (see section 4.5)
Danish: Supplerende behandling - med CYP3A4induktorer (se pkt.
English: The combination of Zonegran with other medicinal products that may lead to urolithiasis may enhance the risk of developing kidney stones; therefore the concomitant administration of such medicinal products should be avoided.
Danish: Kombinationen af Zonegran med andre lægemidler, som kan medføre urolithiasis kan øge risikoen for udvikling af nyresten.
English: Increase at two-weekly intervals in increments of 1 mg/kg
Danish: Øges med 2-ugers intervaller i trin af 1 mg/kg
English: Adjunctive therapy - with CYP3A4inducing agents
Danish: Supplerende behandling - med CYP3A4induktorer
English: Paediatric population (aged 6 years and above) - recommended down-titration schedule
Danish: Tabel 3 Pædiatrisk population (på 6 år og derover) - anbefalet nedtitreringsskema Vægt