FrancophonIA/ELRC3.0 huggingface dataset:
English: If the doctor advises stopping treatment, follow their instructions concerning the gradual reduction of Inovelon in order to lower the risk of an increase in seizures.
Danish: Hvis lægen tilråder at holde op med behandlingen, skal du følge deres instrukser vedrørende den gradvise reduktion af Inovelon for at mindske risikoen for en øgning af anfald.
English: If the doctor prescribes or recommends an additional treatment for epilepsy (e.g., valproate) you must tell the doctor you are taking Inovelon as the dose may need adjusting.
Danish: Hvis lægen ordinerer eller anbefaler en yderligere behandling mod epilepsi (f.eks. valproat) skal du fortælle lægen, at du tager Inovelon, da der kan være behov for at justere dosis.
English: Oriented-polyethylene terephthalate (o-PET) bottle with a child-resistant polypropylene (PP) closure; each bottle contains 460 ml of suspension in an outer cardboard carton.
Danish: Oriented-polyethylenterephthalat (o-PET) flaske med en børnesikret polypropylen (PP) lukning, hver flaske indeholder 460 ml suspension i en yderæske af karton.
English: Therefore, it is recommended that you use an additional safe and effective contraceptive method (such as a barrier method, e.g., condoms) when taking Inovelon.
Danish: Det anbefales derfor, at du bruger en ekstra sikker og effektiv præventionsmetode (såsom en barrieremetode, f.eks. kondomer), når du bruger Inovelon.
English: Adults and children taking valproate at the same time as rufinamide will result in high levels of rufinamide in the blood.
Danish: Voksne og unge, der tager valproat samtidigt med rufinamid, vil få høje niveauer af rufinamid i blodet.
English: Marketing Authorisation Holder: Eisai GmbH
Danish: Indehaver af markedsføringstilladelsen: Eisai GmbH
English: - Inovelon is a white slightly viscous suspension.
Danish: - Inovelon er en hvid, let viskøs suspension.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
Danish: Hyppigheder defineres som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000).
English: EXPIRY DATE EXP (MM/YYYY)
Danish: UDLØBSDATO EXP (MM/ÅÅÅÅ)
English: Tell the doctor if you have any of the following:
Danish: Fortæl det til lægen, hvis du har nogle af følgende bivirkninger:
English: A dose adjustment of the concomitantly administered medicinal product may need to be considered.
Danish: Det kan være nødvendigt at overveje en dosisjustering af det samtidigt administrerede lægemiddel.
English: If patients develop new seizure types and/or experience an increased frequency of status epilepticus that is different from the patient's baseline condition, then the benefit-risk ratio of the therapy should be reassessed.
Danish: Hvis patienterne udvikler nye krampetyper og/eller oplever en øget hyppighed af status epilepticus, som er forskellig fra patientens baselinetilstand, bør forholdet mellem fordele og ulemper ved behandlingen revurderes.
English: Rufinamide should be withdrawn gradually to reduce the possibility of seizures on withdrawal.
Danish: Rufinamid bør seponeres gradvist for at reducere muligheden for anfald ved seponeringen.
English: A pharmacokinetic study in older healthy volunteers did not show a significant difference in pharmacokinetic parameters compared with younger adults.
Danish: Et farmakokinetisk studie hos ældre raske forsøgspersoner viste ingen signifikant forskel i farmakokinetiske parametre sammenlignet med yngre voksne.
English: If you are pregnant, or think you might be pregnant, or are planning to get pregnant, ask the doctor or pharmacist for advice before taking Inovelon.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager Inovelon.
English: Inovelon contains a medicine called rufinamide.
Danish: Inovelon indeholder et lægemiddel, der kaldes rufinamid.
English: In reproductive and developmental toxicity studies, there were reductions in foetal growth and survival, and some stillbirths secondary to maternal toxicity.
Danish: I reproduktions- og udviklingstoksicitetsstudier sås reduktion i føtal vækst og overlevelse og nogle dødfødsler sekundært til maternel toksicitet.
English: If you have difficulty swallowing, you can crush the tablet, then mix the powder in about half a glass (100 ml) of water and drink immediately.
Danish: Hvis du har svært ved at synke, kan du knuse tabletten og blande pulveret i et halvt glas vand (100 ml), der skal drikkes med det samme.
English: Use in children from 1 year to less than 4 years of age
Danish: Anvendelse hos børn fra 1 år til under 4 år
English: The dose will be calculated for you by the doctor and will depend on your age, weight and whether you are taking Inovelon with another medicine called valproate.
Danish: Dosen vil blive beregnet til dig af lægen og vil afhænge af din alder, vægt og hvorvidt du tager Inovelon sammen med et andet lægemiddel, der hedder valproat.
English: Status epilepticus cases have been observed during treatment with rufinamide in clinical development studies, whereas no such cases were observed with placebo.
Danish: Tilfælde af status epilepticus har været observeret under behandling med rufinamid i kliniske udviklingsstudier, mens der ikke blev observeret sådanne tilfælde med placebo.
English: Inovelon has been given to you by your doctor to reduce the number of your seizures or fits.
Danish: Din læge har givet dig Inovelon for at reducere antallet af anfald eller kramper.
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 metaanalyse af randomiserede placebokontrollerede forsøg med antiepileptika har også vist en lille forhøjet risiko for selvmordstanker og -adfærd.
English: Rufinamide was evenly distributed between erythrocytes and plasma.
Danish: Rufinamid blev distribueret ensartet mellem erytrocytter og plasma.
English: Such evaluations indicate that sex does not affect the pharmacokinetics of rufinamide to a clinically relevant extent.
Danish: Disse vurderinger tyder på, at køn ikke påvirker rufinamids farmakokinetik i klinisk relevant omfang.
English: In a thorough QT study, rufinamide produced a decrease in QTc interval proportional to concentration.
Danish: I et grundigt QT-studie bevirkede rufinamid en reduktion af QTc-intervallet, der var proportionalt med koncentrationen.
English: However, no effects on morphology and function, including learning or memory, were observed in the offspring.
Danish: Imidlertid blev der hos afkommet ikke observeret virkninger på morfologi og funktion, herunder indlæring eller hukommelse.
English: Multiple dosing of 7,200 mg/day was associated with no major signs or symptoms.
Danish: Gentagne doser på 7.200 mg/dag var ikke forbundet med større tegn eller symptomer.
English: For patients on Inovelon treatment who have administration of valproate initiated, significant increases in rufinamide plasma concentrations may occur.
Danish: Hos patienter, der behandles med Inovelon, og som påbegynder behandling med valproat, kan der forekomme signifikante stigninger i plasmakoncentrationerne af rufinamid.
English: Inovelon should be administered with food (see section 5.2).
Danish: Inovelon bør administreres sammen med mad (se pkt.
English: Inovelon oral suspension also contains sorbitol and, therefore, should not be administered to patients with rare hereditary problems of fructose intolerance.
Danish: Inovelon oral suspension indeholder også sorbitol og bør derfor ikke administreres til patienter med hereditær fructoseintolerans.
English: Antiepileptic medicines and Inovelon
Danish: Antiepileptika og Inovelon
English: The doctor may need to adjust the dose.
Danish: Lægen skal eventuelt justere dosis.
English: Serious antiepileptic medicinal product hypersensitivity syndrome including DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome have occurred in association with rufinamide therapy.
Danish: Alvorligt antiepileptikum-overfølsomhedssyndrom, herunder DRESS (lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer) og Stevens-Johnsons syndrom, er forekommet i forbindelse med rufinamidbehandling.
English: Population pharmacokinetic modelling has been used to evaluate the influence of sex on the pharmacokinetics of rufinamide.
Danish: Populationsfarmakokinetisk modellering har været brugt til at vurdere indflydelsen af køn på rufinamids farmakokinetik.
English: Benign bone neoplasms (osteomas) and hyperostosis seen in mice were considered a result of the activation of a mouse specific virus by fluoride ions released during the oxidative metabolism of rufinamide.
Danish: Benigne knogleneoplasmer (osteomer) og hyperostose, som blev set hos mus, blev vurderet til at være et resultat af aktiveringen af en musespecifik virus som følge af udløste fluorioner under den oxidative metabolisering af rufinamid.
English: It is not known if rufinamide is excreted in human breast milk.
Danish: Det er ukendt, om rufinamid udskilles i human mælk.
English: Psychomotor hyperactivity
Danish: Psykomotorisk hyperaktivitet
English: The addition or withdrawal of these medicinal products or adjusting of the dose of these medicinal products during rufinamide therapy may require an adjustment in dosage of rufinamide (see section 4.2).
Danish: Tilføjelse eller seponering af disse lægemidler eller dosisjustering af disse lægemidler under behandling med rufinamid kan kræve en dosisjustering af rufinamid (se pkt.
English: Inovelon with food and drink
Danish: Brug af Inovelon sammen med mad og drikke
English: Therefore, consideration should be given to a dose reduction of Inovelon in patients who are initiated on valproate therapy (see section 4.2).
Danish: Derfor bør det overvejes at reducere dosis af Inovelon hos patienter, som påbegynder behandling med valproat (se pkt.
English: Leave the adaptor in place and replace cap on bottle.
Danish: Lad adapteren blive på plads, og sæt igen låget på flasken.
English: Inovelon oral suspension contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
Danish: Inovelon oral suspension indeholder parahydroxybenzoater, som kan give allergiske reaktioner (kan optræde efter behandlingen).
English: - if you take this medicine and have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away (see section 4).
Danish: - hvis du tager dette lægemiddel, og på et eller andet tidspunkt tænker på at skade dig selv eller begå selvmord, skal du straks kontakte lægen eller tage på hospitalet (se punkt 4).
English: Turn upside down and withdraw the prescribed amount of Inovelon from the bottle.
Danish: Vend på hovedet, og træk den ordinerede dosis Inovelon ud af flasken.
English: It may not be excluded that rufinamide may also decrease the exposure of substances metabolised by other enzymes, or transported by transport proteins such as P-glycoprotein.
Danish: Det kan ikke udelukkes, at rufinamid ligeledes kan nedsætte eksponeringen af stoffer, som metaboliseres af andre enzymer, eller som transporteres af transportproteiner så som P-glykoprotein.
English: The frequency, type and severity of these adverse reactions were similar to that in children 4 years of age and older, adolescents and adults.
Danish: Hyppigheden, typen og sværhedsgraden for disse bivirkninger svarede til dem for børn i alderen 4 år og ældre, unge samt voksne.
English: If women treated with rufinamide plan to become pregnant, the continued use of this product should be carefully weighed.
Danish: Hvis kvinder, der behandles med rufinamid planlægger at blive gravide, bør en fortsat anvendelse af dette produkt vurderes nøje.
English: Population pharmacokinetic/pharmacodynamic modelling demonstrated that the reduction of total and tonic-atonic seizure frequencies, the improvement of the global evaluation of seizure severity and the increase in probability of reduction of seizure frequency were dependent on rufinamide concentrations.
Danish: Populationsfarmakokinetisk/farmakodynamisk modellering viste, at reduktionen af total og tonisk-atonisk anfaldsfrekvens, forbedringen af den samlede evaluering af sværhedsgraden af anfald og øgningen af sandsynligheden for reduktion af anfaldsfrekvensen var afhængig af rufinamidkoncentrationerne.
English: Adults, adolescents and children weighing 30 kg or over The recommended starting dose is 400 mg a day.
Danish: Voksne, unge og børn, der vejer 30 kg eller derover Den anbefalede startdosis er 400 mg dagligt.
English: Sorbitol (E420), liquid (non-crystallising)
Danish: Sorbitol (E420), flydende (ikke-krystalliserende)
English: - you have Congenital Short QT Syndrome or a family history of such a syndrome (electrical disturbance of the heart), as taking rufinamide could make it worse.
Danish: - hvis du har medfødt kort QT-syndrom eller har haft sådan et syndrom i familien (elektriske forstyrrelser af hjertet), da indtagelse af rufinamid kan forværre dette.
English: In in -vitro studies, only a small fraction of rufinamide (34%) was bound to human serum proteins with albumin accounting for approximately 80% of this binding.
Danish: I in -vitro studier var kun en lille fraktion af rufinamid (34 %) bundet til humane serumproteiner med albumin, som var ansvarlig for ca. 80 % af denne binding.
English: If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest whole 100 mg tablet.
Danish: Hvis den anbefalede beregnede dosis Inovelon ikke er mulig, skal dosis gives med den nærmeste hele 100 mg tablet.
English: The pharmacokinetic interactions between rufinamide and other antiepileptic medicinal products have been evaluated in patients with epilepsy, using population pharmacokinetic modelling.
Danish: De farmakokinetiske interaktioner mellem rufinamid og andre antiepileptika er blevet evalueret hos patienter med epilepsi ved hjælp af populationsfarmakokinetisk modellering.
English: Cytochrome P450-mediated metabolism is very minor.
Danish: Cytokrom P450-medieret metabolisme er meget lille.
English: Maximum plasma levels are reached approximately 6 hours after administration.
Danish: De maksimale plasmakoncentrationer nås ca. 6 timer efter indgivelse.
English: No data on the interaction of rufinamide with alcohol are available.
Danish: Der foreligger ingen data vedrørende rufinamids interaktion med alkohol.
English: - The active substance is rufinamide.
Danish: - Aktivt stof: rufinamid.
English: Patients must be advised to exercise caution during activities requiring a high degree of alertness, e.g., driving or operating machinery.
Danish: Patienter bør rådes til at udvise forsigtighed under aktiviteter, som kræver høj koncentration, f.eks. at føre motorkøretøj eller betjene maskiner.
English: If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest 0.5 ml of rufinamide.
Danish: Hvis den anbefalede beregnede dosis Inovelon ikke er mulig, skal dosen gives med den nærmeste 0,5 ml rufinamid.
English: Studies in animals revealed no teratogenic effect, but foetotoxicity in the presence of maternal toxicity was observed (see section 5.3).
Danish: Dyrestudier afslørede ingen teratogen virkning, men føtotoksicitet ved maternel toksicitet blev observeret (se pkt.
English: Inovelon oral suspension and Inovelon film-coated tablets have been demonstrated to be bioequivalent.
Danish: Inovelon oral suspension og Inovelon filmovertrukne tabletter har vist sig at være bioækvivalente.
English: These recommendations should also be considered when rufinamide is used concomitantly with substances with a narrow therapeutic window such as warfarin and digoxin.
Danish: Disse anbefalinger bør ligeledes overvejes, når rufinamid anvendes samtidigt med stoffer med et snævert terapeutisk indeks som f.eks. warfarin og digoxin.
English: Eating disorder Decreased appetite Anxiety
Danish: Spiseforstyrrelser Nedsat appetit
English: The toxicity profile of rufinamide in juvenile animals was similar to that in adult animals.
Danish: Toksicitetsprofilen for rufinamid hos unge dyr svarede til profilen for voksne dyr.
English: AED treatment during pregnancy should be carefully discussed with the treating physician.
Danish: Behandling med antiepileptika under graviditeten skal diskuteres nøje med den behandlende læge.
English: If you are taking the following medicines: phenobarbital, fosphenytoin, phenytoin or primidone, you may need to be carefully monitored for two weeks at the start of, or after the end of treatment with rufinamide, or after any marked change in the dose.
Danish: Hvis du tager følgende lægemidler: phenobarbital, fosphenytoin, phenytoin eller primidon, kan det være nødvendigt at overvåge dig nøje i to uger ved begyndelsen af behandlingen eller efter endt behandling med rufinamid, eller efter alle markante dosisændringer.
English: Ask the doctor or pharmacist for advice before taking any medicine at the same time as Inovelon.
Danish: Spørg lægen eller apoteket til råds, inden du tager nogen form for medicin samtidigt med Inovelon.
English: This indicates minimal risk of drug-drug interactions by displacement from binding sites during concomitant administration of other substances.
Danish: Dette tyder på en minimal risiko for lægemiddel-lægemiddel interaktioner gennem fortrængning fra bindingsstederne ved samtidig indgift af andre stoffer.
English: - you experience difficulty walking, abnormal movement, dizziness or sleepiness inform the doctor, if any of these happen.
Danish: - hvis du oplever gangbesvær, unormale bevægelser, svimmelhed eller søvnighed, skal du informere lægen, hvis noget af dette sker.
English: The plasma elimination half-life is approximately 6-10 hours in healthy subjects and patients with epilepsy.
Danish: Eliminationshalveringstiden i plasma er ca. 6-10 timer hos raske forsøgspersoner og patienter med epilepsi.
English: Central Nervous System reactions
Danish: Reaktioner i centralnervesystemet
English: Inovelon is used with other medicines to treat seizures associated with Lennox-Gastaut syndrome in adults, adolescents and children from 1 year of age.
Danish: Inovelon bruges sammen med andre lægemidler til at behandle anfald i forbindelse med Lennox-Gastaut-syndrom hos voksne, unge og børn fra 1 år.
English: Children aged between 1 and 4 years of age
Danish: Børn mellem 1 og 4 år
English: No data are available on the effects on fertility following treatment with rufinamide.
Danish: Der foreligger ingen data for virkningen på fertilitet efter behandling med rufinamid.
English: Tell your doctor if you are taking valproate as the dose of Inovelon may need to be reduced by your doctor.
Danish: Fortæl det til lægen, hvis du tager valproat, da det kan være nødvendigt, at lægen reducerer din dosis af Inovelon.
English: Caution and careful dose titration is recommended when treating patients with mild to moderate hepatic impairment.
Danish: Forsigtighed og omhyggelig dosistitrering anbefales ved behandling af patienter med let til moderat nedsat leverfunktion.
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 ºC.
English: The cap should be replaced after each use.
Danish: Låget skal sættes på efter hver brug.
English: The discontinuation rate in Lennox-Gastaut syndrome due to adverse reactions was 8.2% for patients receiving rufinamide and 0% for patients receiving placebo.
Danish: Seponeringshyppigheden ved Lennox-Gastaut-syndrom på grund af bivirkninger var 8,2 % for patienter, der fik rufinamid, og 0 % for patienter, der fik placebo.
English: If they happen to you tell your doctor or go to a hospital immediately:
Danish: Hvis det sker, skal du fortælle det til lægen eller straks tage på hospitalet.
English: Push down and turn cap to open bottle
Danish: Tryk låget ned, og drej det for at åbne flasken.
English: Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.
Danish: Behandling med rufinamid bør initieres af en læge med speciale i pædiatri eller neurologi med erfaring i behandling af epilepsi.
English: When rufinamide treatment is to be discontinued, it should be withdrawn gradually.
Danish: Når behandlingen med rufinamid skal seponeres, bør det ske gradvist.
English: Although the underlying mechanism and safety relevance of this finding is not known, clinicians should use clinical judgment when assessing whether to prescribe rufinamide to patients at risk from further shortening their QTc duration (e.g., Congenital Short QT Syndrome or patients with a family history of such a syndrome).
Danish: Selvom den underliggende mekanisme og betydning for sikkerheden ikke kendes, bør klinikere anvende et klinisk skøn, når der skal tages stilling til, om der skal ordineres rufinamid til patienter med risiko for yderligere afkortning af QTc-varigheden (f.eks. medfødt kort QTc-syndrom eller patienter med en familieanamnese med et sådant syndrom).
English: Inovelon oral suspension and Inovelon film-coated tablets may be interchanged at equal doses.
Danish: Inovelon oral suspension og Inovelon filmovertrukne tabletter kan udskiftes med hinanden ved lige store doser.
English: Inovelon may cause dizziness, somnolence and blurred vision.
Danish: Inovelon kan medføre svimmelhed, døsighed og sløret syn.
English: Adverse reactions were usually mild to moderate in severity.
Danish: Bivirkningerne var sædvanligvis lette til moderate i sværhedsgrad.
English: PHARMACEUTICAL FORM AND CONTENTS Oral suspension 460 ml.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Oral suspension 460 ml.
English: Children generally have lower clearance of rufinamide than adults, and this difference is related to body size with rufinamide clearance increasing with body weight.
Danish: Børn har almindeligvis lavere rufinamidclearance end voksne, og denne forskel er relateret til kropsstørrelsen, da rufinamidclearance øges med legemsvægten.
English: There is no specific antidote for rufinamide.
Danish: Der findes ingen specifik antidot til rufinamid.
English: Rufinamide treatment has been associated with dizziness, somnolence, ataxia and gait disturbances, which could increase the occurrence of accidental falls in this population (see section 4.8).
Danish: Rufinamidbehandling har været forbundet med svimmelhed, døsighed, ataksi og gangforstyrrelser, som kunne øge forekomsten af utilsigtede fald i denne population (se pkt.
English: - you suffer an increase in the number or severity or duration of your seizures, you should contact the doctor immediately if this happens.
Danish: - hvis hyppigheden, sværhedsgraden eller varigheden af dine anfald øges, skal du kontakte lægen omgående, hvis det sker.
English: Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement.
Danish: Imidlertid fik patienterne typisk, skønt ikke udelukkende, feber og udslæt associeret med inddragelse af andre organsystemer.
English: Inovelon oral suspension must be taken twice every day, once in the morning and once in the evening.
Danish: Inovelon oral suspension skal tages to gange dagligt, om morgenen og om aftenen.
English: Each carton contains 1 bottle, 2 syringes and 1 press-in-bottle adapter (PIBA).
Danish: Hver karton indeholder 1 flaske, 2 sprøjter og 1 press-in-bottle adapter (PIBA).
English: Mild toxicity in the liver was observed in juvenile as well as in adult animals at exposure levels lower than or similar to those reached in patients.
Danish: Der blev observeret let levertoksicitet hos unge og voksne dyr ved eksponeringsniveauer, der enten var lavere end eller svarede til de opnåede niveauer hos patienterne.
English: Inovelon contains sorbitol
Danish: Inovelon indeholder sorbitol
English: Weight decrease Head injury
Danish: Vægttab Beskadigelse af hoved