FrancophonIA/ELRC3.0 huggingface dataset:
English: In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and bicuculline.
Danish: Hos dyremodeller antagoniserer stiripentol krampeanfald, der er induceret af elektrisk stød, pentetrazol og bicucullin.
English: - Valproate
Danish: - Valproat
English: In case stiripentol therapy is continued during breast-feeding, the breast-fed infant should be carefully observed for potential adverse effects.
Danish: Hvis behandlingen med stiripentol fortsættes under amning, bør det ammende spædbarn observeres nøje for eventuelle bivirkninger.
English: Paediatric population pharmacokinetic study
Danish: Pædiatrisk farmakokinetisk populationsundersøgelse
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke udført studier af virkninger på evnen til at føre motorkøretøj eller betjene maskiner.
English: Cmax of the sachet was slightly higher (23%) compared with the capsule and did not meet the criteria for bioequivalence.
Danish: Cmax i brevene var let forhøjet (23%) sammenlignet med kapslerne og opfyldte dermed ikke kriteriet for bioækvivalens.
English: Clearance and volume of distribution were related to body weight by an allometric model with exponents of 0.433 and 1, respectively: as body weight increased from 10 to 60 kg, apparent oral clearance increased from 2.60 to 5.65 L/hr and apparent volume of distribution increased from 32.0 to 191.8 L. As a result, elimination half-life increased from 8.5hr (for 10 kg) to 23.5 hr (for 60 kg).
Danish: Clearance og fordelingsvolumen var relateret til kropsvægten med en allometrisk model med eksponenter på henholdsvis 0,433 og 1: efterhånden som kropsvægten blev øget fra 10 til 60 kg, tydelig oral clearance øget fra 2,60 til 5,65 L/time og tydelig fordelingsvolumen øget fra 32,0 til 191,8 L. Som resultat heraf øges eliminationshalveringstiden fra 8,5 timer (for 10 kg) til 23.5 timer (for 60 kg).
English: The potential for metabolic interaction between stiripentol and valproate is considered modest and thus, no modification of valproate dosage should be needed when stiripentol is added, except for clinical safety reasons.
Danish: Muligheden for metabolisk interaktion mellem stiripentol og valproat anses for at være moderat, og der bør derfor ikke være behov for ændring af doseringen af valproat, når stiripentol tilføjes, medmindre det sker af hensyn til den kliniske sikkerhed.
English: 90 hard capsules
Danish: 90 hårde kapsler
English: These substances should not be used in conjunction with stiripentol in the management of Dravet's syndrome.
Danish: Disse stoffer bør ikke anvendes sammen med stiripentol i behandlingen af Dravets syndrom.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL ELLER AFFALD HERFRA
English: such as anorexia, loss of appetite, vomiting, your child's growth rate should be carefully monitored.
Danish: såsom anoreksi, manglende appetit eller opkastning, bør Deres barns vækstrate overvåges meget nøje.
English: Your child should take Diacomit with food, it should NOT be taken on an empty stomach.
Danish: Deres barn skal tage Diacomit sammen med mad og ikke på tom mave.
English: Talk to your child's doctor or pharmacist before taking Diacomit
Danish: Kontakt lægen eller apoteket, før Deres barn tager Diacomit
English: If your child experiences any problems when switching from taking the capsules to the powder for oral suspension or vice versa please inform your doctor.
Danish: Hvis Deres barn oplever problemer ved at skifte mellem kapsler og pulver til oral suspension eller omvendt, skal De kontakte Deres læge.
English: Risk related to stiripentol
Danish: Risici forbundet med stiripentol
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number} [product code]
Danish: UNIK IDENTIFIKATOR - DATA SOM KAN LÆSES AF ET MENNESKE PC: {number} [produktkode]
English: The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well established.
Danish: Andre antiepileptiske præparaters påvirkning af farmakokinetikken for stiripentol er ikke fastlagt nøje.
English: In that case carry on with the next dose as normal.
Danish: I det tilfælde skal barnet fortsætte den normale procedure og tage den næste dosis.
English: - Cisapride, halofantrine, pimozide, quinidine, bepridil Increased risk of cardiac arrhythmias and torsades de pointes/wave burst arrhythmia in particular.
Danish: - Cisaprid, halofantrin, pimozid, quinidin, bepridil Øget risiko for hjertearytmier og især Torsades de Pointes/wave burst-artymier.
English: • double vision when used in combination with the antiepileptic medicine carbamazepine;
Danish: • dobbeltsyn ved anvendelse i kombination med det antiepileptiske lægemiddel carbamazepin;
English: As a consequence, it is recommended that children between 6 months and 3 years of age are carefully monitored whilst on stiripentol therapy.
Danish: Det anbefales derfor, at børn mellem 6 måneder og 3 år overvåges nøje under behandling med stiripentol.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. kapsel, dvs. det er i det væsentlige natrium-frit.
English: The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards dose escalation to reach the recommended dose of 50 mg/kg/day administered in conjunction with clobazam and valproate.
Danish: Påbegyndelse af adjuverende behandling med stiripentol bør ske gradvist ved optitrering af dosis for at nå den anbefalede dosis på 50 mg/kg/dag, som indgives sammen med clobazam og valproat.
English: Please consult your child's doctor in the event of any side effects as the doctor may have to adjust the dose of this medicine and the other antiepileptic medicine(s).
Danish: Spørg barnets læge til råds i tilfælde af bivirkninger, da lægen muligvis vil være nødt til at justere dosisen af dette lægemiddel og det eller de andre antiepileptiske lægemidler.
English: Potential for stiripentol to interact with other medicinal products
Danish: Muligheden for, at stiripentol interagerer med andre lægemidler
English: PHARMACEUTICAL FORM Powder for oral suspension Pale pink crystalline powder
Danish: LÆGEMIDDELFORM Pulver til oral suspension Svagt lyserødt krystallinsk pulver
English: • ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia
Danish: • manglende evne til at koordinere muskelbevægelser (ataksi), lav muskelstyrke (hypotoni),
English: Plasma clearance decreases markedly at high doses; it falls from approximately 40 l/kg/day at the dose of 600 mg/day to about 8 l/kg/day at the dose of 2,400 mg. Clearance is decreased after repeated administration of stiripentol, probably due to inhibition of the cytochrome P450 isoenzymes responsible for its metabolism.
Danish: Plasmaclearancen falder markant ved høje doser; fra cirka 40 l/kg/dag ved dosis på 600 mg/dag til cirka 8 l/kg/dag ved dosis på 2.400 mg. Clearancen falder efter gentagen indgivelse af stiripentolsandsynligvis på grund af hæmningen af cytokrom P450's isoenzymer, der er ansvarlige for dets metabolisme.
English: In case of switch between capsule and powder formulations it should be done under the close supervision of the doctor.
Danish: Hvis der skiftes mellem kapsler og pulverformuleringer, skal det ske under nøje overvågning af lægen.
English: The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI.
Danish: Den pivotale kliniske evaluering af stiripentol blev foretaget med børn på 3 år og derover, som havde SMEI.
English: Your child must NOT take Diacomit
Danish: Deres barn må IKKE tage Diacomit
English: Given the frequency of gastrointestinal adverse reactions to treatment with stiripentol and valproate (anorexia, loss of appetite, nausea, vomiting), the growth rate of children under this combination of treatment should be carefully monitored.
Danish: I betragtning af hyppigheden af gastrointestinale bivirkninger ved behandlingen med stiripentol og valproat (anoreksi, appetitløshed, nausea, opkastning), bør vækstraten hos børn i denne behandlingskombination overvåges nøje.
English: - Topiramate
Danish: - Topiramat
English: In the event of an abnormal blood count or liver function test finding, the clinical decision for continuing use or adjusting the dose of stiripentol in conjunction with adjusting the doses of clobazam and valproate needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks (see section 4.4).
Danish: I tilfælde af unormale resultater af blodtællinger eller leverfunktionstest skal den kliniske beslutning om fortsat anvendelse eller justering af dosis af stiripentol sammen med justering af dosis af clobazam og valproat træffes på individuel patientbasis under hensyntagen til de potentielle kliniske fordele og risici (se pkt.
English: Clinical supervision is recommended if switching between the stiripentol capsule and powder for oral suspension in sachet formulations.
Danish: Klinisk supervision anbefales, hvis det er nødvendigt at skifte mellem stiripentol kapsler og pulverformulering til oral suspension i breve.
English: The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons.
Danish: De hårde kapsler leveres i plastbeholder, der indeholder 30, 60 eller 90 kapsler i papkartoner.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing severity.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: In the pivotal studies, when the use of stiripentol was initiated, the daily dose of clobazam was 0.5 mg/kg/day usually administered in divided doses, twice daily.
Danish: I de pivotale forsøg var den daglige dosis clobazam, da behandlingen med stiripentol blev iværksat, 0,5 mg/kg/dag, hvilket normalt blev indgivet i inddelte doser to gange dagligt.
English: If your child takes more Diacomit than he or she should Contact your child's doctor if you know or think your child has taken more medicine than he or she should have.
Danish: Hvis Deres barn har taget for menget Diacomit Kontakt barnets læge, hvis De ved eller tror, at Deres barn har taget mere medicin, end han/hun burde.
English: Your child's doctor will tell you the new dose of the other antiepileptic medicine(s).
Danish: Deres barns læge vil informere Dem om den nye dosis af det eller de andre antiepileptiske lægemidler.
English: Thrombocytopenia *
Danish: Trombocytopeni*
English: • loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate);
Danish: • appetitløshed, vægttab (især ved kombination med det antiepileptiske lægemiddel natriumvalproat);
English: • aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable);
Danish: • aggressivitet, irritabilititet, uro, usædvanlig pirrelighed (hyperexcitabilitet);
English: BIOCODEX 1 avenue Blaise Pascal, 60000 Beauvais FRANCE
Danish: BIOCODEX 1 avenue Blaise Pascal, 60000 Beauvais FRANKRIG
English: Capsule core
Danish: Udvendig kapsel
English: Tutti frutti flavour (contains sorbitol) Carmellose sodium Hydroxyethylcellulose
Danish: Tutti frutti-smag (indeholder sorbitol) Natriumcarboxymethylcellulose Hydroxyethylcellulose
English: In this case, please see below: “Diacomit contains aspartame, glucose, sorbitol and sodium”.
Danish: Se nedenstående :“ Diacomit indeholder aspartam, glukose, sorbitol og natrium ”, hvis det er tilfældet.
English: Caffeine (this substance helps restore mental alertness) or theophylline (this substance is used in case of asthma).
Danish: Caffein (dette stof er med til at skærpe opmærksomheden) eller theophyllin (dette stof bruges i tilfælde af astma).
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, eller apoteket.
English: The most common side effects with stiripentol are anorexia, weight loss, insomnia, drowsiness, ataxia, hypotonia and dystonia.
Danish: De mest almindelige bivirkninger med stiripentol er anoreksi, vægttab, søvnbesvær, døsighed, ataksi, hypotoni og dystoni.
English: For these children the use of stiripentol will be done under the close supervision of the doctor.
Danish: Anvendelsen af stiripentol til disse børn skal ske under nøje opsyn af lægen.
English: With regard to topiramate, it is considered that potential competition of inhibition on CYP2C19 should not occur because it probably requires plasma concentrations 5-15 times higher than plasma concentrations obtained with the standard recommended topiramate dose and dosage schedules.
Danish: For så vidt angår topiramat mener man ikke, at det er sandsynligt, at potentiel kompetition af hæmningen af CYP2C19 vil opstå, da det sandsynligvis kræver plasmakoncentrationer, som er 5-15 gange højere end de plasmakoncentrationer, der opnås ved den almindelige anbefalede dosis af topiramat og doseringsskemaerne for topiramat.
English: In this younger group of patients, adjunctive therapy with stiripentol should only be started when the diagnosis of SMEI has been clinically confirmed (see section 5.1).
Danish: Hos denne gruppe af yngre patienter bør der kun iværksættes adjuverende behandling med stiripentol, når diagnosen på SMEI er blevet klinisk bekræftet (se pkt.
English: Increased risk of dose-dependent adverse reactions such as rhabdomyolysis (decreased hepatic metabolism of cholesterol-lowering medicinal product).
Danish: Øget risiko for dosisafhængige bivirkninger, såsom rhabdomyolyse (nedsat levermetabolisme af kolesterolsænkende lægemiddel).
English: Studies in the rat on fertility and general reproductive performance and on pre- and postnatal development were uneventful except for a minor reduction in the survival of pups nursed by mothers exhibiting toxic responses to stiripentol at a dose of 800 mg/kg/day (see section 4.6).
Danish: Resultaterne af undersøgelser på rotter af fertiliteten og den generelle reproduktionsevne og på den præ- og postnatale udvikling var ganske normale, bortset fra et mindre fald i overlevelsen af unger, der diede hos mødre, som udviste toksiske reaktioner på stiripentol ved en dosis på 800 mg/kg/dag (se pkt.
English: Stiripentol powder for oral suspension in sachet contains aspartame, a source of phenylalanine.
Danish: Stiripentol pulver til oral suspension i breve indeholder aspartam, som er en kilde til phenylalanin.
English: Abnormal laboratory findings
Danish: Unormale laboratoriefund
English: PHARMACEUTICAL FORM AND CONTENTS 30 hard capsules
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 30 hårde kapsler
English: The second effect of stiripentol is mainly based on metabolic inhibition of several isoenzymes, in particular CYP450 3A4 and 2C19, involved in the hepatic metabolism of other anti-epileptic medicines.
Danish: Den anden virkning af stiripentol er hovedsageligt baseret på metabolisk hæmning af adskillige isoenzymer, især CYP450 3A4 og 2C19, der er involveret i levermetabolismen af andre antiepileptiske lægemidler.
English: Based on the clinical observations in this group of patients, there is no evidence to suggest that a change in topiramate dose and dosage schedules is needed if coadministered with stiripentol.
Danish: På baggrund af de kliniske observationer i denne gruppe patienter er der intet, der tyder på, at en ændring i dosis af topiramat eller i doseringsskemaerne er nødvendig i forbindelse med samtidig indgivelse af stiripentol.
English: Your child should take this medicine two or three times a day at regular intervals as directed by your child's doctor: for example morning - noon - bed-time to cover the night-and-day period.
Danish: Deres barn skal tage dette lægemiddel to til tre gange om dagen med regelmæssige intervaller og efter Deres barns læges anvisninger: for eksempel morgen, middag og sengetid for at dække hele døgnet.
English: Aspartame (E951) Sorbitol
Danish: Aspartam (E951)
English: There are slight differences between the Diacomit capsules and powder for oral suspension.
Danish: Der er en lille forskel mellem Diacomit som kapsler og som breve med pulver til oral suspension.
English: How to take the Diacomit capsules
Danish: Hvordan Diacomit kapsler skal tages
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
English: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17
Danish: Farmakoterapeutisk klassifikation: Antiepileptika, øvrige antiepileptika, ATC-kode N03AX17
English: In view of the lack of genotoxicity of stiripentol and the well-known, special susceptibility of the mouse liver to tumour formation in the presence of hepatic enzyme induction, this finding is not considered to indicate a risk of tumorigenicity in patients.
Danish: I betragtning af den manglende genotoksicitet ved stiripentol og museleverens velkendte specielle disponering for tumordannelse i forbindelse med induktion af leverenzymer anses dette fund ikke for at være en indikation på risiko for tumorgenicitet for patienterne.
English: Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with theophylline and caffeine cannot be excluded because of increased plasma levels of theophylline and caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity.
Danish: Data vedrørende muligheden for hæmning af CYP1A2 er begrænsede, og interaktioner med theophyllin og caffein kan derfor ikke udelukkes på grund af øgede plasmaniveauer af theophyllin og caffein, som kan opstå via hæmning af deres levermetabolisme, hvilket potentielt kan føre til toksicitet.
English: Your child should take this medicine two or three times a day at regular intervals as directed by your child's doctor, for example morning - noon - bed-time to cover the night-and-day period.
Danish: Deres barn skal tage dette lægemiddel to til tre gange om dagen med regelmæssige intervaller og efter Deres barns læges anvisninger, for eksempel morgen, middag og sengetid for at dække hele døgnet.
English: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antiepileptika, øvrige antiepileptika, ATC-kode N03AX17 Handlingsmekanisme
English: Toxicity studies in animals (rat, monkey, mouse) have not revealed any consistent pattern of toxicity apart from liver enlargement associated with hepatocellular hypertrophy, which occurred when high doses of stiripentol were administered to both rodents and nonrodents.
Danish: Toksicitetsundersøgelser på dyr (rotte, abe, mus) har ikke afsløret noget vedvarende toksicitetsmønster bortset fra leverforstørrelse, der var forbundet med hepatocellulær hypertrofi, som opstod, da høje doser stiripentol blev indgivet til både gnavere og ikke-gnavere.
English: • nausea, vomiting;
Danish: • kvalme, opkastning;
English: • insomnia (sleeplessness), drowsiness;
Danish: • søvnløshed (insomni), døsighed;
English: No impact on fertility was detected in animal studies (see section 5.3).
Danish: Dyreforsøg viser ingen indvirkning på fertilitet (se pkt.
English: If your child forgets to take Diacomit
Danish: Hvis Deres barn har glemt at tage Diacomit
English: Aggressiveness, irritability, behaviour disorders, opposing behaviour, hyperexcitability, sleep disorders
Danish: Aggressivitet, irritabilitet, adfærdsforstyrrelser , stædighed, hyperirritabilitet, søvnforstyrrelser
English: In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes.
Danish: In vitro studier har vækket formodning om, at stiripentol fase 1 metabolisme katalyseres af CYP1A2, CYP2C19 og CYP3A4 og muligvis andre enzymer.
English: Raised γ-GT
Danish: Forhøjet γGT
English: It should be assessed prior to starting treatment with stiripentol.
Danish: Den bør vurderes, inden behandlingen med stiripentol påbegyndes.
English: Diacomit contains aspartame, glucose, sorbitol and sodium This medicine contains 2.5 mg aspartame in each 250mg-sachet and 5 mg each 500mg-sachet.
Danish: Diacomit indeholder aspartam, glukose, sorbitol og natrium Dette lægemiddel indeholder 2,5 mg aspartam i hvert 250 mg brev og 5 mg i hvert 500 mg brev.
English: Dose adjustments of other antiepileptics used in combination with stiripentol Despite the absence of comprehensive pharmacology data on potential drug interactions, the following advice regarding modification of the dose and dosage schedules of other anti-epileptic medicinal products administered in conjunction with stiripentol is provided based on clinical experience.
Danish: Dosisjusteringer af andre antiepileptika, der anvendes i kombination med stiripentol På trods af manglen på omfattende farmakologiske data for potentielle lægemiddelinteraktioner kan vi på baggrund af den kliniske erfaring give følgende vejledning vedrørende ændring af dosis og doseringsskemaer for andre antiepileptiske præparater, der indgives samtidig med stiripentol.
English: Your child should not use any tools, machines, ride or drive if affected in this way.
Danish: Hvis barnet påvirkes på denne måde, må barnet ikke bruge værktøj, maskiner, ride eller køre bil. Spørg barnets læge til råds.
English: (involuntary muscle contractions).
Danish: ufrivillige muskelsammentrækninger (dystoni).
English: This medicine contains sorbitol: 2.4 mg in each 250mg-sachet and 4.8 mg in each 500mg-sachet.
Danish: Dette lægemiddel indeholder sorbitol: 2,4 mg i hvert 250 mg brev og 4,8 mg i hvert 500 mg brev.
English: It is used in conjunction with clobazam and valproate (other antiepileptic medicines) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet's syndrome), which affects children.
Danish: Det anvendes sammen med clobazam og valproat (andre antiepileptiske lægemidler) til behandling af en bestemt form for epilepsi, der kaldes for Dravet syndrom (Severe Myoclonic Epilepsy in Infancy), som rammer børn.
English: Cartons contain either 30, 60 or 90 sachets.
Danish: Kartonerne indeholder enten 30, 60 eller 90 breve.
English: Bottles of 30, 60 and 90 capsules in cardboard cartons.
Danish: Flasker med 30, 60 og 90 kapsler i papkartoner.
English: In view of the indication, administration of stiripentol during pregnancy and in women of childbearing potential would not be expected.
Danish: På grund af indikationen kan det ikke forventes, at stiripentol vil blive anvendt under graviditet eller til fertile kvinder.
English: • raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate;
Danish: • forhøjede niveauer af leverenzymer, især ved indgivelse sammen med de antiepileptiske lægemidler carbamazepin og natriumvalproat;
English: How to take the Diacomit powder for oral suspension The powder should be mixed in a glass of water and should be taken immediately after mixing during the meal.
Danish: Hvordan Diacomit pulver til oral suspension skal tages Pulveret skal blandes i et glas vand og indtages umiddelbart efter opblanding og under måltidet.
English: Other medicines and Diacomit
Danish: Brug af anden medicin sammen med Diacomit
English: This warning is not only restricted to medicinal products but also to a considerable number of foods and nutritional products aimed at children: Patient should not drink cola drinks, which contain significant quantities of caffeine or chocolate, which contains trace amounts of theophylline (see section 4.2).
Danish: Denne advarsel er ikke kun begrænset til lægemidler, men gælder også et betydeligt antal fødevarer og næringsprodukter, som er rettet mod børn: Patienterne bør ikke drikke coladrikke, der indeholder betydelige mængder caffein, og chokolade, som indeholder spormængder af theophyllin (se pkt.
English: Driving and using machines This medicine may make your child feel sleepy.
Danish: Dette lægemiddel kan medføre, at Deres barn bliver søvnig.