FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no clinical study data to support the clinical safety of stiripentol administered at daily doses greater than 50 mg/kg/day.
Danish: Der er ingen kliniske studiedata, der understøtter den kliniske sikkerhed ved stiripentol administreret med daglige doser på over 50 mg/kg/dag.
English: • The capsule shell is made of gelatine, titanium dioxide (E171).
Danish: • Kapslens yderside er fremstillet af gelatine, titandioxid (E171).
English: You can also report side effects directly via the national reporting system listed in Appendix V.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.
English: Stiripentol is quickly absorbed, with a time to peak plasma concentration of about 1.5 hours.
Danish: Tiden indtil maksimal plasmakoncentration er cirka 1,5 timer.
English: Nausea, vomiting
Danish: Kvalme, opkastninger
English: When to take Diacomit
Danish: Hvornår Diacomit skal tages
English: Biocodex, 1 avenue Blaise Pascal - F-60000 Beauvais - France
Danish: 1 avenue Blaise Pascal - F-60000 Beauvais - Frankrig
English: Tel: +49 (0)40 59101 525 e-mail: epi.info@desitin.de
Danish: Tlf.: +49 (0)40 59101 525 e-mail: epi.info@desitin.de
English: • Your child's blood count should be assessed prior to starting Diacomit and checked every 6
Danish: • Deres barns blodtælling bør vurderes, før behandlingen med Diacomit påbegyndes, og kontrolleres hver 6. måned.
English: Blood counts should be assessed prior to starting treatment with stiripentol.
Danish: Der bør derfor foretages vurderinger af blodtællinger, inden behandlingen med stiripentol påbegyndes.
English: Your child should always take the contents of each sachet exactly as your child's doctor has told you.
Danish: Deres barn skal altid tage indholdet af hvert brev i nøje overensstemmelse med barnets læges anvisninger.
English: In the pivotal studies in the event of gastrointestinal adverse reactions such as loss of appetite, loss of weight, the daily dose of valproate was reduced by around 30% every week.
Danish: I de tilfælde, hvor der optrådte bivirkninger, såsom appetitløshed og vægttab, blev den daglige dosis valproat reduceret med cirka 30% hver uge i de pivotale forsøg.
English: Photosensitivity, rash, cutaneous allergy, urticaria
Danish: Fotosensibilitet , udslæt, hudallergi, urticaria
English: For food and drinks to be avoided, see the section “Diacomit with food and drink” above.
Danish: Se “Hvordan man tager Diacomit sammen med mad og drikkevarer” ovenfor vedrørende oplysninger om mad- og drikkevarer, der skal undgås.
English: At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for example, CYP2C19, CYP2D6 and CYP3A4.
Danish: I terapeutiske koncentrationer hæmmer stiripentol markant mindst to CYP450-isoenzymer: for eksempel CYP2C19, CYP2D6 og CYP3A4.
English: Clinical monitoring of plasma levels of other anticonvulsants when combined with stiripentol with possible dose adjustments is recommended.
Danish: Det anbefales at foretage en klinisk overvågning af plasmaniveauerne af andre antikonvulsiva og eventuelt at justere dosis, når disse kombineres med stiripentol.
English: Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.
Danish: Diacomit er indiceret til anvendelse sammen med clobazam og valproat som adjuverende behandling af refraktær generaliserede tonisk-kloniske kramper hos patienter med Dravet syndrome (Severe Myoclonic Epilepsy in Infancy; SMEI), hvis kramperne ikke kan kontrolleres tilstrækkeligt med clobazam og valproat.
English: PHARMACEUTICAL FORM Hard capsule
Danish: LÆGEMIDDELFORM Kapsel, hård
English: • The other ingredients of the capsule are povidone K29/32, sodium starch glycolate type A and magnesium stearate.
Danish: • De øvrige indholdsstoffer i kapslen er povidon K29/32, natriumstivelsesglycol type A og magnesiumstearat.
English: Each sachet contains 5 mg of aspartame, 1,000 mg of glucose liquid spray and 4.8 mg of sorbitol.
Danish: Hvert brev indeholder 5 mg aspartam, 1.000 mg spraytørret, flydende glucose og 4,8 mg sorbitol.
English: Excipient with known effect
Danish: Hjælpestoffer med kendt effekt:
English: Anorexia, loss of appetite, weight loss
Danish: Anoreksi, appetitløshed, vægttab
English: The daily dosage of clobazam and/or valproate should be reduced according to the onset of side effects whilst on stiripentol therapy (see section 4.2).
Danish: Den daglige dosis af clobazam og/eller valproat bør reduceres på baggrund af bivirkningers indtræden under behandlingen med stiripentol (se pkt.
English: Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.4).
Danish: Stiripentol anbefales ikke til anvendelse til patienter med svækket lever- og/eller nyrefunktion (se pkt.
English: The clinical decision for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks (see section 4.2).
Danish: Den kliniske beslutning om anvendelse af Diacomit til børn med SMEI på under 3 år skal træffes på individuel patientbasis under hensyntagen til de potentielle kliniske fordele og risici (se pkt 4.2).
English: You should check with your child's doctor or pharmacist if you are not sure.
Danish: De bør konsultere barnets læge eller apoteket, hvis der er noget, De er i tvivl om eller usikker på.
English: If you have the impression that the effect of this medicine is too strong or too weak, talk to your child's doctor or pharmacist.
Danish: Hvis De har indtryk af, at virkningerne af dette lægemiddel er for kraftige eller for svage, bør De tale med Deres barns læge eller apoteket om det. Dosisen vil blive justeret af lægen alt efter Deres barns tilstand.
English: The clinical decision for use of stiripentol in pregnancy needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks.
Danish: Den kliniske beslutning om anvendelse af stiripentol under graviditet skal træffes på individuel patientbasis under hensyntagen til de potentielle kliniske fordele og risici.
English: Your child must not stop taking this medicine unless the doctor tells you to.
Danish: Hvis Deres barn holder op med at tage Diacomit Deres barn må ikke holde op med at tage dette lægemiddel, medmindre det sker efter lægens anvisning.
English: LIST OF EXCIPIENTS Contains sodium.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder natrium.
English: Sodium starch glycolate (type A)
Danish: Natriumstivelsesglycolat (type A) Magnesiumstearat
English: What you need to know before your child takes Diacomit
Danish: Det skal De vide, før Deres barn begynder at tage Diacomit
English: Czech Republic Tel: 00420-2-222 45 375 e-mail: desitin@desitin.cz
Danish: Czech Republik Tel: 00420-2-222 45 375 e-mail: desitin@desitin.cz
English: How to store Diacomit
Danish: Hvordan De opbevarer Diacomit
English: • decrease of platelet level in the blood;
Danish: • Nedsat antal blodplader
English: Boxes of 30, 60 and 90 sachets.
Danish: Kasser med 30, 60 og 90 breve.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 250 mg
English: To eliminate these side effects, your child's doctor may have to change the dose of Diacomit or one of the other medicines prescribed for your child.
Danish: Deres barns læge vil muligvis være nødt til at ændre dosis af Diacomit eller af et af de andre lægemidler for at fjerne disse bivirkninger.
English: 0.32 mg sodium per capsule.
Danish: 0,32 mg natrium pr. kapsel.
English: 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: 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: MARKETING AUTHORISATION HOLDER Biocodex, 7 Avenue Gallieni, 94250 Gentilly, France.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Biocodex, 7 Avenue Gallieni, 94250 Gentilly, Frankrig.
English: Polypropylene bottle with tamper-evident seal and polyethylene screw cap.
Danish: Polypropylenflaske med berøringssikret forsegling og skruelåg af polyethylen.
English: There are no clinical study data to support the use of stiripentol as monotherapy in Dravet's syndrome.
Danish: Der er ingen kliniske studiedata, der understøtter brugen af stiripentol som monoterapi ved Dravets syndrom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET LABEL TEXT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREVETIKET-TEKST
English: • if your child is allergic to stiripentol or to any of the other ingredients of Diacomit.
Danish: • hvis barnet er allergisk (overfølsom) over for stiripentol eller et af de øvrige indholdsstoffer i
English: Titanium dioxide (E171) Erythrosine (E127) Indigotine (E132)
Danish: Titandioxid (E171) Erythrosin (E127) Indigotin (E132)
English: Diacomit is also available as 250 mg and 500 mg capsules for oral use
Danish: Diacomit fås også som 250 mg kapsler og 500 mg kapsler til oral anvendelse.
English: Stiripentol potentiates the efficacy of other anticonvulsants, such as carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result of pharmacokinetic interactions.
Danish: Som følge af farmakokinetiske interaktioner forstærker Stiripentol effekten af andre antikonvulsiva såsom carbamazepin, natriumvalproat, phenytoin, phenobarbital og mange benzodiazepiner.
English: • medicines containing: - cisapride (used to treat symptoms of night time heartburn); - pimozide (used to treat the symptoms of Tourette's syndrome e.g. vocal outbursts and uncontrolled, repeated movements of the body); - ergotamine (used to treat migraine); - dihydroergotamine (used to relieve the signs and symptoms of decreased mental capacity due to the aging process); - halofantrine (an antimalarial treatment); - quinidine (used to treat abnormal heart rhythms); - bepridil (used to control chest pain); - cyclosporine, tacrolimus, sirolimus (all three used to prevent rejections of liver, kidney and heart transplants); - statins (simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood).
Danish: • lægemidler, der indeholder: - cisaprid (bruges til behandling af symptomer på halsbrand om natten); - pimozid (bruges til behandling af symptomer på Tourettes sygdom, for eksempel udstøden af lyde og ukontrollerede, gentagne kropsbevægelser); - ergotamin (bruges til behandling af migræne); - dihydroergotamin (bruges til lindring af tegn og symptomer på nedsat mental kapacitet, som skyldes aldringsprocessen); - halofantrin (en behandling mod malaria); - quinidin (bruges til behandling af unormale hjerterytmer); - bepridil (bruges til behandling af brystsmerter); - ciclosporin, tacrolimus, sirolimus (alle tre midler anvendes til at forebygge, at lever-, nyre- og hjertetransplantater afvises); - statiner (simvastatin og atorvastatin, der begge bruges til at nedsætte indholdet af kolesterol i blodet).
English: 60 sachets
Danish: 60 breve
English: Powder for oral suspension in sachet 30 sachets
Danish: Pulver til oral suspension i brev 30 breve
English: For the interaction of stiripentol with food, see section 4.5.
Danish: 4.5 vedrørende stiripentols interaktion med mad.
English: The clinical decision for use of stiripentol in children with SMEI less than 3 years of age needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks.
Danish: Den kliniske beslutning om anvendelse af stiripentol til børn med SMEI på under 3 år skal træffes på individuel patientbasis under hensyntagen til de potentielle kliniske fordele og risici.
English: phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
Danish: - antiepileptiske lægemidler, der indeholder: phenobarbital, primidon, phenytoin, carbamazepin, diazepam.
English: Diacomit is also available as 250 mg and 500 mg powder for oral suspension in sachets.
Danish: Diacomit fås også som 250 mg og 500 mg pulver til oral suspension i breve.
English: Stiripentol was not teratogenic when tested in the rat and rabbit; in one study in the mouse, but not in several other similar studies, a low incidence of cleft palate formation was observed at a maternotoxic dose (800 mg/kg/day).
Danish: I en enkelt undersøgelse på mus (men ikke i adskillige andre lignende undersøgelser) blev en lav forekomst af ganespaltedannelse observeret ved en maternotoksisk dosis (800 mg/kg/dag).
English: The powder should be mixed in a glass of water and should be taken immediately after mixing.
Danish: Pulveret skal blandes i et glas vand og indtages umiddelbart efter opblanding.
English: Your child should always take these capsules exactly as your child's doctor has told you.
Danish: Deres barn skal altid tage disse kapsler i nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens eller apotekspersonalets anvisning.
English: tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.
Danish: (indeholder sorbitol), natriumcarboxymethylcellulose, hydroxyethylcellulose.
English: Each sachet contains 2.5 mg of aspartame, 500 mg of glucose liquid spray and 2.4 mg of sorbitol.
Danish: Hvert brev indeholder 2,5 mg aspartam, 500 mg spraytørret, flydende glucose, og 2,4 mg sorbitol.
English: Drowsiness, ataxia, hypotonia, dystonia
Danish: Døsighed, ataksi, hypotoni, dystoni
English: Unless otherwise clinically indicated, blood counts should be checked every 6 months.
Danish: Blodtællingerne bør kontrolleres hver 6. måned, medmindre andet er klinisk indiceret.
English: The impact of macrolides and azole antifungal medicinal products on stiripentol metabolism, that are known to be inhibitors of CYP3A4 and substrates of the same enzyme, is not known.
Danish: Det er ukendt, hvordan makrolider og azolantimykotiske lægemidler, som man ved er hæmmere af CYP3A4 og substrater af samme enzym, indvirker på stiripentols metabolisme.
English: Very common side effects (may affect more than one in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 personer):
English: Stiripentol is an inhibitor of the enzymes CYP2C19, CYP3A4 and CYP2D6 and may markedly increase the plasma concentrations of substances metabolised by these enzymes and increase the risk of adverse reactions (see section 4.5).
Danish: Stiripentol hæmmer enzymerne CYP2C19 og CYP3A4, CYP2D6 og kan medføre en markant stigning i plasmakoncentrationerne af stoffer, der metaboliseres af disse enzymer, og øge risikoen for uønskede hændelser (se pkt.
English: What Diacomit 250 mg contains
Danish: Diacomit 250 mg indeholder
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale pakning for at beskytte mod lys.
English: Approximately two to three-fold increases in clobazam and five-fold increases in norclobazam plasma levels respectively have been reported with co-administration of stiripentol in children with Dravet's syndrome.
Danish: I forbindelse med ledsagende indgivelse af stiripentol til børn med Dravets syndrom er der blevet indberettet cirka to- til tredobbelte stigninger i plasmaniveauerne af clobazam og femdobbelte stigninger i plasmaniveauerne af norclobazam.
English: What Diacomit 500 mg contains
Danish: Diacomit 500 mg indeholder
English: Unless otherwise clinically indicated, liver function should be checked every 6 months.
Danish: Leverfunktionen bør kontrolleres hver 6. måned, medmindre andet er klinisk indiceret.
English: Stiripentol should not be taken with milk or dairy products (yoghurt, soft cream cheese, etc.), carbonated drinks, fruit juice or food and drinks that contain caffeine or theophylline.
Danish: Stiripentol bør ikke tages sammen med mælk eller mælkeprodukter (youghurt, blød flødeost osv.), kulsyreholdige drikkevarer, frugtjuice eller mad eller drikke indeholdende koffein eller theophyllin.
English: Undesirable combinations (to be avoided unless strictly necessary) - Rye ergot alkaloids (ergotamine, dihydroergotamine) Ergotism with possibility of necrosis of the extremities (inhibition of hepatic elimination of rye ergot).
Danish: Uønskede kombinationer (skal undgås, medmindre det er strengt nødvendigt) - Sekalealkaloider(ergotamin, dihydroergotamin)
English: Diacomit 250 mg hard capsule Diacomit 500 mg hard capsule stiripentol
Danish: Diacomit 250 mg hårde kapsler Diacomit 500 mg hårde kapsler stiripentol
English: Size 2 pink capsule
Danish: Lyserød kapsel, størrelse 2
English: Size 0, white capsule
Danish: LÆGEMIDDELFORM Kapsel, hård Hvid kapsel, størrelse 0
English: The powder should be mixed in a glass of water and should be taken immediately after mixing during a meal.
Danish: Pulveret skal blandes i et glas vand og indtages umiddelbart efter opblanding og under måltidet.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL TEXT
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER FLASKEETIKET-TEKST
English: • abnormal liver function test
Danish: • Unormal leverfunktionstest
English: Glucose liquid spray dried Sodium
Danish: Spraytørret, flydende glucose Natrium
English: midazolam or triazolam (medicines used to reduce anxiety and sleeplessness - in combination with Diacomit they may make your child very sleepy);
Danish: - lægemidler, der indeholder: midazolam eller triazolam (lægemidler, der bruges til behandling af angst og søvnløshedkombineret med Diacomit gør de Deres barn meget søvnigt); chlorpromazin (bruges til psykisk sygdom såsom psykose).
English: LIST OF EXCIPIENTS Contains sodium
Danish: LISTE OVER HJÆLPESTOFFER Indeholder natrium
English: What Diacomit 500 mg looks like and contents of the pack This medicine is a pale pink powder supplied in sachets.
Danish: Udseende og pakningsstørrelser Diacomit 500 mg Dette lægemiddel er et svagt lyserødt pulver, der leveres i breve.
English: • Your child's liver function should be assessed prior to starting Diacomit and checked every 6
Danish: • Deres barns blodtælling bør evalueres, før behandlingen med Diacomit påbegyndes, og kontrolleres hver 6. måned.
English: 90 sachets
Danish: 90 breve
English: - medicines containing:
Danish: Oversigt over indlægssedlen:
English: • The capsule shell is made of gelatine, titanium dioxide (E171), erythrosine (E127), indigotin
Danish: Kapslens yderside er fremstillet af gelatine, titandioxid (E171), erythrosin (E127), indigotin (E132).
English: 21 patients on stiripentol had moderate side-effects (drowsiness, loss of appetite) compared with eight on placebo, but side-effects disappeared when the dose of comedication was decreased in 12 of the 21 cases (Chiron et al, Lancet, 2000).
Danish: 21 patienter på stiripentol havde moderate bivirkninger (døsighed, appetitløshed) sammenlignet med 8 på placebo.
English: Blood count
Danish: Blodtælling
English: What Diacomit 250 mg looks like and contents of the pack This medicine is a pale pink powder supplied in sachets.
Danish: Udseende og pakningsstørrelser Diacomit 250 mg Dette lægemiddel er et svagt lyserødt pulver, der leveres i breve.
English: 0.11 mg sodium per sachet.
Danish: 0,11 mg natrium pr. brev.
English: What Diacomit 500 mg looks like and contents of the pack Diacomit 500 mg hard capsules are white.
Danish: Udseende og pakningsstørrelser Diacomit 500 mg Diacomit 500 mg hårde kapsler er hvide.
English: Biocodex,7 avenue Gallieni - F-94250 Gentilly - France Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
Danish: 7 avenue Gallieni - F-94250 Gentilly - Frankrig Tlf.: + 33 1 41 24 30 00 - E-mail: webar@biocodex.fr
English: Inhibition of CYP450 isoenzyme CYP2C19 and CYP3A4 may provoke pharmacokinetic interactions (inhibition of their hepatic metabolism) with phenobarbital, primidone, phenytoin, carbamazepine, clobazam (see section 4.2), valproate (see section 4.2), diazepam (enhanced myorelaxation), ethosuximide, and tiagabine.
Danish: - Virkninger på andre antiepileptiske lægemidler (AED'er) Hæmning af CYP450-isoenzym CYP2C19 og CYP3A4 kan fremprovokere farmakokinetiske interaktioner (hæmning af deres levermetabolisme) sammen med phenobarbital, primidon, phenytoin, carbamazepin, clobazam (se pkt.
English: INFORMATION IN BRAILLE Diacomit 250 mg powder for oral suspension
Danish: INFORMATION I BRAILLE-SKRIFT Diacomit 250 mg pulver til oral suspension
English: INFORMATION IN BRAILLE Diacomit 500 mg powder for oral suspension
Danish: INFORMATION I BRAILLE-SKRIFT Diacomit 500 mg pulver til oral suspension
English: In the absence of specific clinical data in patients with impaired hepatic or renal function, Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.2).
Danish: Hvis specifikke kliniske data for patienter med svækket lever- eller nyrefunktion mangler, frarådes det at anvende stiripentol til patienter med svækket lever- og/eller nyrefunktion (se punkt 4.2).
English: Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).
Danish: Brug af Diacomit sammen med mad og alkohol sammen med mad og drikkevarer Diacomit må IKKE tages sammen med mælk eller andre mejeriprodukter (youghurt, smøreoste osv.), frugtjuice, kulsyreholdige drikkevarer eller mad og drikkevarer, der indeholder caffein eller theophyllin (for eksempel cola, chokolade, kaffe, te og energidrikke).
English: - If you have any further questions, ask your child's doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller på apoteket.
English: 0.22 mg sodium per sachet.
Danish: 0,22 mg natrium pr. brev.
English: Each hard capsule contains 250 mg of stiripentol.
Danish: Hver hård kapsel indeholder 250 mg stiripentol.
English: Most stiripentol is excreted via the kidney.
Danish: Det meste stiripentol udskilles via nyrerne.
English: Insomnia
Danish: Søvnbesvær
English: Tel: + 33 1 41 24 30 00 e-mail: webar@biocodex
Danish: Tlf.: + 33 1 41 24 30 00 E-mail: webar@biocodex
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC: SN:
English: Tel: + 33 1 41 24 30 00 e-mail: webar@biocodex.fr
Danish: Tlf.: + 33 1 41 24 30 00 E-mail: webar@biocodex.fr
English: Rare side effects (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer):
English: BIOCODEX 7 avenue Gallieni 94250 Gentilly France
Danish: BIOCODEX 7 avenue Gallieni 94250 Gentilly Frankrig