FrancophonIA/ELRC3.0 huggingface dataset:
English: A French compassionate use program included children from 6 months of age because the diagnosis of Dravet's syndrome may be made with confidence at that age in some patients.
Danish: I et fransk compassionate use-program deltog børn fra 6 måneder, da diagnosen på Dravets syndrom kan stilles med sikkerhed i den alder hos nogle patienter.
English: Date of latest renewal: 08 January 2014
Danish: Fornyelse af tilladelsen: 8. januar 2014
English: No data on exposed pregnancies are available.
Danish: Der foreligger ingen data om eksponerede graviditeter.
English: Your child's doctor has prescribed this medicine to help treat your child's epilepsy.
Danish: Deres barns læge har ordineret dette lægemiddel til behandling af Deres barns epilepsi.
English: The half-life of elimination was in the range of 4.5 hours to 13 hours, increasing with dose.
Danish: Elimineringshalveringstiden var inden for området 4,5 timer til 13 timer, hvilket steg i takt med dosis.
English: • if your child has kidney or liver problems.
Danish: • hvis Deres barn har nyre- eller leverproblemer.
English: These capsules should be swallowed whole with water.
Danish: Disse kapsler skal sluges hele sammen med vand.
English: Children aged less than 3 years
Danish: Børn under 3 år
English: The population estimate for the absorption rate constant Ka was 2.08 hr-1 (standard deviation of random effect = 122%).
Danish: Populations estimeringen for absorberingsraten konstant Ka var på 2,08 time -1 (standard afvigelse af vilkårlig effekt = 122 %).
English: Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Danish: Risici forbundet med epilepsi og antiepileptiske præparater generelt Det er blevet påvist, at hos børn af kvinder med epilepsi er prævalensen af misdannelser to til tre gange højere end de cirka 3% for den almindelige population.
English: This could occur by inhibition of synaptosomal uptake of GABA and/or inhibition of GABA transaminase.
Danish: Dette kan ske ved hæmning af den synaptosomale optagelse af GABA og/eller hæmning af GABA-transaminasen.
English: • hyperkinesis (exaggerated movements);
Danish: • overdrevne bevægelser (hyperkinesis);
English: If your child forgets to take a dose, he or she should take it as soon as you remember unless it is time for the next dose.
Danish: Hvis Deres barn glemmer at tage en dosis, skal han/hun tage den, så snart De kommer i tanke om det, medmindre det er på tidspunktet for den næste dosis.
English: The recommended dose of 50 mg/kg/day is based on the available clinical study findings and was the only dose of Diacomit evaluated in the pivotal studies (see section 5.1).
Danish: Den anbefalede dosis på 50 mg/kg/dag er baseret på tilgængelige resultater fra kliniske studier og var den eneste Diacomitdosis, der blev evalueret i de pivotale forsøg (se punkt 5.1).
English: It should always be taken in combination with clobazam and valproate under the direction of a doctor.
Danish: Det skal altid tages sammen med clobazam og valproat efter en læges vejledning.
English: Aspartame is a source of phenylalanine.
Danish: Aspartam er en kilde til phenylalanin.
English: Urinary metabolites of stiripentol accounted collectively for the majority (73%) of an oral acute dose whereas a further 13-24% was recovered in faeces as unchanged substance.
Danish: Metabolitter af stiripentol i urinen udgjorde samlet størstedelen (73%) af en oral akut dosis, mens yderligere 13-24% blev konstateret i fæces som uændret stof.
English: A dose-adjustment may be necessary for substances metabolised by CYP2D6 and that are individually dose titrated.
Danish: En dosisjustering kan være nødvendig for stoffer, der metaboliseres af CYP2D6, og som dosistitreres individuelt.
English: Effect of stiripentol on cytochrome P450 enzymes
Danish: Virkningen af stiripentol på cytochrom P450-enzymer
English: Stiripentol binds extensively to circulating plasma proteins (about 99%).
Danish: Stiripentol binder i omfattende grad til cirkulerende plasmaproteiner (cirka 99%).
English: Tell your doctor if your child is taking any of the following medicines:
Danish: Fortæl det til Deres læge, hvis Deres barn tager et af følgende lægemidler:
English: The increase in steady state levels with the combined use of stiripentol, valproate, and clobazam is similar in adults and children, though inter-individual variability is marked.
Danish: Stigningen i steady state-niveauerne ved den kombinerede anvendelse af stiripentol, valproat og clobazam er ens hos voksne og børn, om end variationen fra person til person er udtalt.
English: Monitoring of plasma concentrations or adverse reactions is recommended.
Danish: Det anbefales at overvåge plasmakoncentrationer eller bivirkninger.
English: 15 (71%) patients were responders on stiripentol (including nine free of clonic or tonic-clonic seizures), whereas there was only one (5%) on placebo (none was seizure free; stiripentol 95% CI 52.1-90.7 vs. placebo 0-14.6).
Danish: 15 (71%) patienter reagerede på stiripentol (herunder 9, der var fri for kliniske eller tonisk-kloniske krampeanfald), mens der kun var 1 (5%), der reagerede på placebo (ingen var krampefri; stiripentol 95% CI 52,1-90,7 vs. placebo 0-14,6).
English: The capsule should be swallowed whole with a glass of water.
Danish: Kapslen skal sluges hel sammen med et glas vand.
English: Stopping treatment suddenly can lead to an outbreak of seizures.
Danish: Et pludseligt ophør i behandlingen kan føre til et udbrud af krampeanfald.
English: However, some patients may experience dizziness and ataxia that may affect ability to drive and use machines and patients should not drive or use machinery whilst on stiripentol therapy.
Danish: Nogle patienter kan imidlertid opleve døsighed og ataksi, som kan påvirke evnen til at føre motorkøretøj og betjene maskiner, og patienterne bør ikke føre motorkøretøj eller betjene maskiner, mens de er i behandling med stiripentol.
English: In the mouse there was only a small increase in the incidence of hepatic adenomas and carcinomas in animals treated with 200 or 600 mg/kg/day for 78 weeks but not in those given 60 mg/kg/day.
Danish: Hos mus var der kun en lille stigning i forekomsten af leveradenomer og -karcinomer hos dyr, der blev behandlet med 200 eller 600 mg/kg/dag i 78 uger, men ikke hos dem, der fik 60 mg/kg/dag.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis Deres læge har sagt, at De har intolerans over for visse sukkerarter, skal De kontakte lægen, før dette lægemiddel tages.
English: - Chlorpromazine Stiripentol enhances the central depressant effect of chlorpromazine.
Danish: - Chlorpromazin Stiripentol forstærker chlorpromazins sederende effekt.
English: Responders were defined as having more than 50% reduction in the frequency of clonic (or tonicclonic) seizures during the second month of the double-blind period compared with baseline.
Danish: Reagerende patienter blev defineret som dem, der havde mere end 50% reduktion i hyppigheden af kloniske (eller tonisk-kloniske) krampeanfald i den anden måned af den dobbeltblinde periode sammenlignet med baseline.
English: Systemic exposure to stiripentol increases markedly compared to dose proportionality.
Danish: Den systemiske eksponering for stiripentol stiger markant sammenlignet med dosisproportionaliteten.
English: Levetiracetam does not undergo hepatic metabolism to a major extent.
Danish: Levetiracetam gennemgår ikke levermetabolisme i større udstrækning.
English: Relative bioavailability between the capsules and powder for oral suspension in sachet formulations has been studied in healthy male volunteers after a 1,000 mg single oral administration.
Danish: Relativ biotilgængelighed mellem kapsler og pulverformulering til oral suspension i breve er blevet undersøgt hos raske, frivillige mænd efter indgift af en enkelt oral dosis på 1.000 mg.
English: The following pharmacokinetic properties of stiripentol have been reported from studies in adult healthy volunteers and adult patients.
Danish: Nedenstående farmakokinetiske egenskaber for stiripentol er blevet indberettet fra forsøg på raske, voksne frivillige samt på voksne patienter.
English: The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not bioequivalent.
Danish: Formuleringen i brevene har en lidt højere Cmax end kapslerne, og derfor har formuleringerne ikke den samme bioækvivalens.
English: The absolute bioavailability of stiripentol is not known since an intravenous formulation is not available for testing.
Danish: Den absolutte biotilgængelighed for stiripentol kendes ikke, da en intravenøs udformning ikke findes til forsøgsmæssige formål.
English: As the flavouring component contains small amount of sorbitol, patients with hereditary problems of fructose intolerance should not take this medicine.
Danish: Da smagsbestanddelen indeholder en lille mængde sorbitol, bør patienter med hereditære problemer med fructoseintolerans ikke tage dette lægemiddel.
English: • Because the frequency of gastrointestinal side effect with Diacomit, clobazam and valproate,
Danish: • På grund af hyppigheden af gastrointestinale bivirkninger med Diacomit, clobazam og valproat,
English: After a baseline period of 1 month, placebo (n=20) or stiripentol (n=21) was added to valproate and clobazam during a double-blind period of 2 months.
Danish: Efter en baselineperiode på 1 måned blev placebo (n=20) eller stiripentol (n=21) tilføjet til valproat og clobazam i en dobbeltblind periode på 2 måneder.
English: If your child has problems with certain ingredients of Diacomit (e.g. aspartame, glucose, sorbitol).
Danish: Hvis Deres barn har problemer med visse af indholdsstofferne i Diacomit (for eksempel aspartam, glucose, sorbitol).
English: Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 30mg/kg/day for 1 week.
Danish: Titrering af stiripentoldosis bør være gradvis, idet der startes med 20 mg/kg/dag i 1 uge efterfulgt af 30 mg/kg/dag i 1 uge.
English: Paediatric population The dose of stiripentol is calculated on a mg/kg body weight basis.
Danish: Dosis af stiripentol beregnes på basis af mg/kg legemsvægt.
English: Carbamazepine, phenytoin and phenobarbital
Danish: Carbamazepin, phenytoin og phenobarbital
English: • sleep disorders (abnormal sleeping);
Danish: • søvnforstyrrelser (unormal søvn);
English: These interactions may result in increased systemic levels of these active substances that may lead to enhanced pharmacological effects and to an increase in adverse reactions.
Danish: Disse interaktioner kan medføre forhøjede systemiske niveauer af disse aktive stoffer, som kan føre til forstærkede farmakologiske effekter og til en stigning i bivirkniger og uønskede hændelser.
English: * Thrombocytopenia data are derived from both clinical trials and post-marketing experience.
Danish: *Data vedrørende trombocytopeni stammer fra både kliniske forsøg og erfaring efter markedsføring.
English: Many of the above adverse reactions are often due to an increase in plasma levels of other anticonvulsant medicinal products (see sections 4.4 and 4.5) and may regress when the dose of these medicinal products is reduced.
Danish: Mange af ovenstående bivirkninger skyldes ofte en stigning i plasmaniveauerne hos andre antikonvulsiva (se pkt.4.4 og 4.5), og de kan forsvinde, når dosis af disse præparater reduceres.
English: Stiripentol is extensively metabolized, 13 different metabolites having been found in urine.
Danish: Stiripentol metaboliseres i omfattende grad. Der er konstateret 13 forskellige metabolitter i urin.
English: Caution is advised when combining stiripentol with other substances that inhibit or induce one or more of these enzymes.
Danish: Det tilrådes at udvise forsigtighed, når stiripentol kombineres med andre stoffer, som hæmmer eller inducerer en eller flere af disse enzymer.
English: The consequences are increased plasma levels of these anticonvulsants with potential risk of overdose.
Danish: Følgerne er øgede plasmaniveauer af disse antikonvulsiva med potentiel risiko for overdosis.
English: Diacomit should only be administered under the supervision of a paediatrician / paediatric neurologist experienced in the diagnosis and management of epilepsy in infants and children.
Danish: Diacomit må kun indgives under opsyn af en pædiater/pædiatrisk neurolog med erfaring i diagnosticering og behandling af epilepsi hos spædbørn og børn.
English: The median age was 7.3 years (range: 1 to 17.6 years) and the median daily dose of stiripentol was 45.4 mg/kg/day (range: 27.1 to 89.3 mg/kg/day) received in two or three divided doses.
Danish: Gennemsnitsalderen var 7,3 år (mellem: 1 til 17,6 år) og den gennemsnitlige daglige dosis stiripentol var 45,4 mg/kg/dag (mellem: 27,1 til 89,3 mg/kg/dag) indtaget i to eller tre dosis.
English: Data on clinical overdose are not available.
Danish: Der findes ingen data vedrørende klinisk overdosering.
English: Dose increases should be gradual, taking place over a few weeks while the dose(s) of the other antiepileptic medicine(s) is (are) reduced at the same time.
Danish: Dosisstigninger bør ske gradvist og finde sted i løbet af få uger, mens dosis af det eller de øvrige antiepileptiske lægemidler samtidigt reduceres.
English: In case of vomiting within the first few minutes of intake it is assumed that no medicine has been absorbed and a new dose should be given.
Danish: Hvis Deres barn kaster op få minutter efter indtagelse af medicinen, formodes det, at ingen medicin er blevet taget og der skal gives en ny dosis.
English: During pregnancy, effective antiepileptic treatment must NOT be stopped.
Danish: Effektiv antiepileptisk behandling må IKKE standses under graviditet.
English: The daily dosage may be administered in 2 or 3 divided doses.
Danish: Den daglige dosis kan indgives i 2 eller 3 inddelte doser.
English: Further dosage escalation is age dependent: - children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus achieving the recommended dose of 50 mg/kg/day in three weeks; - children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus achieving the recommended dose of 50 mg/kg/day in four weeks; - children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week until the optimum dose is reached based on clinical judgment.
Danish: En yderligere dosisstigning er aldersbetinget: - børn under 6 år bør have yderligere 20 mg/kg/dag i den tredje uge og således nå op på den anbefalede dosis på 50 mg/kg/dag i løbet af tre uger; - børn fra 6 til under 12 år bør have yderligere 10 mg/kg/dag hver uge og således nå op på den anbefalede dosis på 50 mg/kg/dag i løbet af fire uger; - børn og unge på 12 år og derover bør have yderligere 5 mg/kg/dag hver uge, indtil den optimale dosis ud fra en klinisk bedømmelse er nået.
English: As a result, pharmacokinetic interactions of metabolic origin with other medicines may be expected.
Danish: Farmakokinetiske interaktioner af metabolisk oprindelse med andre præparater må derfor forventes.
English: The dose is adjusted by the doctor according to your child's age, weight and condition, generally 50 mg per kg bodyweight and per day.
Danish: Lægen justerer dosis alt efter Deres barns alder, vægt og tilstand - normalt til 50 mg pr. kg legemsvægt pr. dag.
English: The pivotal clinical studies did not include children below 3 years old.
Danish: De pivotale kliniske forsøg omfattede ikke børn under 3 år.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Stiripentol has also been shown to enhance GABAA receptor-mediated transmission in the immature rat hippocampus and increase the mean open-duration (but not the frequency) of GABAA receptor chloride channels by a barbiturate-like mechanism.
Danish: Stiripentol har desuden vist sig at forstærke GABAA receptor-medieret transmission i den uudviklede rotte-hippocampus og øge den gennemsnitlige åben-varighed (men ikke hyppigheden) af GABAA-receptorens chloridkanaler ved en barbiturat-lignende mekanisme.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP.
Danish: Indhaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Percentage of change from baseline was higher on stiripentol (-69%) than on placebo (+7%), p<0.0001.
Danish: Procentdelen af ændringen fra baseline var højere for stiripentol (-69%) end placebo (+7%), p<0,0001.
English: 6.6 Special precautions for disposal No special requirements.
Danish: 6.6 Særlige forholdsregler ved bortskaffelse Ingen særlige forholdsregler.
English: - This medicine has been prescribed for your child only.
Danish: - Lægen har kun ordineret dette lægemiddel til Deres barn.
English: As a consequence, it is recommended that children between 6 months and 3 years of age are carefully monitored whilst on Diacomit therapy.
Danish: Det anbefales derfor, at børn mellem 6 måneder og 3 år overvåges nøje under behandling med Diacomit.
English: The combination with Diacomit should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia.
Danish: Kombination med Diacomit bør undgås, da det kan øge deres barns blodniveauer og føre til fordøjelsesproblemer, galoperende hjerte og søvnløshed.
English: A population pharmacokinetic study was conducted in 35 children with Dravet Syndrome treated with stiripentol and two substances not known to affect stiripentol pharmacokinetics, valproate and clobazam.
Danish: En farmakokinetisk populationsundersøgelse blev gennemført på 35 børn med dravet syndrom, de blev behandlet med stiripentol og to stoffer, der så vidt vides, ikke påvirker stiripentol farmakokinetik, valproate og clobazam.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, foetal development, parturition or postnatal development at non-maternotoxic doses (see section 5.3).
Danish: Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger for graviditet, fostrets udvikling, fødslen eller den postnatale udvikling i ikkematernotoksiske doser (se pkt.
English: Potential medicinal product interactions affecting stiripentol
Danish: Potentielle lægemiddelinteraktioner, der påvirker stiripentol
English: If your child is pregnant or breast-feeding, think she may be pregnant or is planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis Deres barn er gravid eller ammer, tror hun er gravid eller planlægger at få et barn, skal De spørge Deres læge til råds, før dette lægemiddel tages.
English: Neutropenia may be associated with the administration of stiripentol, clobazam and valproate.
Danish: Der kan opstå neutropeni i forbindelse med indgivelsen af stiripentol, clobazam og valproat.
English: It is recommended that if a switch of formulations is required this is done under clinical supervision, in case of problems with tolerability (see section 5.2).
Danish: Hvis det er nødvendigt at skifte mellem de to formuleringer, anbefales det at gøre det under klinisk supervision i tilfælde af toleranceproblemer (se pkt.
English: In the event of clinical signs of adverse reactions or overdose of clobazam (i.e., drowsiness, hypotonia, and irritability in young children), this daily dose was reduced by 25% every week.
Danish: I tilfælde af kliniske tegn på uønskede hændelser eller overdosering af clobazam (dvs. døsighed, hypotoni og irritabilitet hos små børn) blev denne daglige dosis reduceret med 25% hver uge.
English: In such a case, it is assumed that a significant fraction of the administered dose has been absorbed systemically from the digestive tract.
Danish: I så fald formodes det, at en betydelig del af den administrerede dosis er blevet absorberet i kroppen via fordøjelsessystemet.
English: Data are limited about the use of stiripentol under 12 months of age.
Danish: Data vedrørende anvendelse af stiripentol til børn under 12 måneder er begrænsede.
English: Dose adjustments of other antiepileptics used in combination with stiripentol
Danish: Dosisjusteringer af andre antiepileptika, der anvendes i kombination med stiripentol
English: Hyperkinesias
Danish: Hyperkinesi
English: • The active substance is stiripentol.
Danish: • Det aktive stof er stiripentol.
English: As a result, no pharmacokinetic metabolic drug interaction between stiripentol and levetiracetam is anticipated.
Danish: Ingen farmakokinetisk metabolisk lægemiddelinteraktion forventes derfor mellem stiripentol og levetiracetam.
English: Tell your child's doctor or pharmacist if your child is using, has recently used or might use any other medicines.
Danish: Fortæl det til Deres læge eller apotekspersonalet, hvis Deres barn bruger, for nyligt har brugt eller muligvis vil bruge andre lægemidler.
English: In a French compassionate use program for stiripentol, topiramate was added to stiripentol, clobazam and valproate in 41% of 230 cases.
Danish: I et fransk compassionate use-program for stiripentol blev topiramat tilføjet stiripentol, clobazam og valproat i 41% af 230 tilfælde.
English: In the absence of available clinical data, caution should be taken with the following clinically relevant interactions with stiripentol:
Danish: På grund af manglende tilgængelige kliniske data skal der udvises forsigtighed i forbindelse med nedenstående klinisk relevante interaktioner med stiripentol:
English: Stiripentol must always be taken with food as it degrades rapidly in an acidic environment (e.g. exposure to gastric acid in an empty stomach).
Danish: Stiripentol skal altid tages sammen med mad, da det hurtigt nedbrydes i et syreholdigt miljø (f.eks. eksponering for mavesyre i en tom mave).
English: In the absence of human studies on excretion in breast milk, and given that stiripentol passes freely from plasma into milk in the goat, breast-feeding is not recommended during treatment.
Danish: Da der ikke foreligger humane undersøgelser af udskillelsen i modermælk, og da stiripentol passerer frit fra plasma og ind i mælken hos geder, frarådes amning under behandling.
English: In rodent models, stiripentol appears to increase brain levels of gamma-aminobutyric acid (GABA) - the major inhibitory neurotransmitter in mammalian brain.
Danish: Hos gnavermodeller er der formodning om, at stiripentol øger niveauerne i hjernen af gamma amino butyric acid (GABA) - den største hæmmende neurotransmitter i pattedyrs hjerne.
English: - Immunosuppressants (tacrolimus, cyclosporine, sirolimus) Raised blood levels of immunosuppressants (decreased hepatic metabolism).
Danish: - Immunsupprimerende midler (tacrolimus, cyclosporin, sirolimus) Forhøjede blodniveauer af immunsupprimerende midler (nedsat levermetabolisme).
English: Co-administration with CYP3A4 substrates with a narrow therapeutic index should be avoided due to the markedly increased risk of severe adverse reactions.
Danish: Ledsagende behandling med CYP3A4-substrater med et smalt terapeutisk indeks bør undgås på grund af den markant øgede risiko for alvorlige bivirkninger.
English: Increased plasma benzodiazepine levels may occur via decreased hepatic metabolism leading to excessive sedation.
Danish: Øgede plasmaniveauer af benzodiazepin kan opstå på grund af nedsat levermetabolisme, hvilket fører til kraftig sedation.
English: Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.