natgillin/translations-raw huggingface dataset:
Da antallet af patienter med SMEI er lavt, betragtes sygdommen som ” sjælden ”, og Diacomit blev udpeget som lægemiddel til sjældne sygdomme den 5. december 2001.
Because the number of patients with SMEI is low, the disease is considered ‘ rare’, and Diacomit was designated as an ‘ orphan medicine ’ (a medicine used in rare diseases) on 5 December 2001.
Behandling med Diacomit må kun gives under overvågning af en læge med speciale i diagnosticering og behandling af epilepsi hos børn og spædbørn (en pædiater eller pædiatrisk neurolog).
Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in infants and children (a paediatrician or paediatric neurologist).
Den normale dosis er 50 mg/ kg kropsvægt, fordelt på to eller tre daglige doser.
The normal dose is 50 mg per kilogram body weight, divided into two or three doses during the day.
Behandlingen påbegyndes som regel med en lav dosis, som i løbet af tre dage gradvist øges til den anbefalede dosis.
Treatment usually starts with a low dose, which is gradually increased to the recommended dose over three days.
Efter påbegyndelsen af behandlingen med Diacomit skal dosen af clobazam muligvis reduceres.
After starting Diacomit, the dose of clobazam may need to be reduced.
Dosen af valproat kræver normalt ingen justering.
The dose of valproate does not normally need to be adjusted.
De primære undersøgelser med Diacomit omfattede børn over tre år.
The main studies of Diacomit were in children over three years of age.
Diacomit skal tages sammen med mad, dog ikke med mælkeprodukter, kulsyreholdige drikke, frugtjuice eller mad eller drikkevarer, der indeholder koffein eller teofyllin (et stof, der bl. a. findes i sort og grøn te).
Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).
Det vides ikke helt præcist, hvordan stiripentol, det aktive stof i Diacomit, virker som epilepsilægemiddel.
The exact way in which stiripentol, the active substance in Diacomit, acts as an anti-epileptic medicine is not fully understood.
Det virker muligvis ved at øge aktiviteten af andre epilepsilægemidler ved at 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
It may also increase the levels of a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Det øger muligvis også koncentrationerne af en ” neurotransmitter ” kaldet gammaaminosmørsyre (GABA) i mellemrummene mellem nervecellerne i hjernen.
Reproduction is authorised provided the source is acknowledged. ‘ neurotransmitter ’ called gamma-aminobutyric acid (GABA) in the gaps between nerve cells in the brain.
Neurotransmittere er stoffer i kroppen, som sender signaler fra en nervecelle til en anden.
Neurotransmitters are substances in the body that relay signals from a nerve cell to another cell.
Virkningerne af Diacomit blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Diacomit were first tested in experimental models before being studied in humans.
De to primære undersøgelser med Diacomit omfattede 65 børn i alderen 3 til 18 år.
The two main studies of Diacomit involved 65 children between three and 18 years of age.
Undersøgelserne havde til formål at sammenligne virkningen af Diacomit- kapsler eller - breve og et placebopræparat (en virkningsløs behandling), når disse blev givet som tillægsbehandling til den behandling, barnet i forvejen fik med clobazam og valproat.
The studies compared the effectiveness of Diacomit capsules or sachets and placebo (a dummy treatment), when they were added to the children ’ s existing treatment with clobazam and valproate.
Det primære mål for virkningen var antallet af patienter, som ” responderede ” på behandlingen.
The main measure of effectiveness was the number of patients who ‘ responded ’ to treatment.
En patient blev klassificeret som ” responderende ”, hvis antallet af anfald i løbet af anden behandlingsmåned var mindst 50% lavere end antallet i måneden før behandlingen blev indledt.
A patient was classified as a ‘ responder ’ if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.
Der var flere patienter, der responderede på behandlingen med Diacomit end med placebobehandlingen.
More patients responded to treatment with Diacomit than to placebo.
I den første undersøgelse responderede 71% af de patienter, der fik Diacomit, på behandlingen (15 ud af 21), sammenlignet med 5% i placebogruppen (1 ud af 20).
In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20).
Der blev observeret lignende resultater i den anden undersøgelse, hvor 67% responderede på Diacomit (8 ud af 12) sammenlignet med 9% i placebogruppen (1 ud af 9).
Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).
Det er dog uklart, om denne virkning skyldes Diacomit i sig selv eller de øgede koncentrationer af de andre epilepsilægemidler.
However, it is not clear whether this effect is due to Diacomit itself or to increased levels of the other anti-epileptic medicines.
De mest almindelige bivirkninger ved Diacomit (der ses hos mere end 1 ud af 10 patienter) er anoreksi (appetitløshed), vægttab, søvnbesvær, døsighed, ataksi (manglende evne til at koordinere muskelbevægelser), hypotoni (lav muskelstyrke) og dystoni (muskellidelser).
The most common side effects with Diacomit (seen in more than 1 in 10 patients) are anorexia (loss of appetite), weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co-ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders).
Den fuldstændige liste over alle de indberettede bivirkninger ved Diacomit fremgår af indlægssedlen.
For the full list of all side effects reported with Diacomit, see the Package Leaflet.
Diacomit bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for stiripentol eller andre af indholdsstofferne.
Diacomit should not be used in people who may be hypersensitive (allergic) to stiripentol or to any of the other ingredients.
Det må ikke anvendes til patienter, der har haft psykoser (en alvorlig psykisk tilstand med forvrænget virkelighedsopfattelse), der involverede delirium (en psykisk tilstand med forvirring, opstemthed, rastløshed og hallucinationer).
It must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Diacomit har vist sig effektivt til behandling af SMEI, dog kun i undersøgelser, der var begrænsede og ikke varede så længe, som udvalget havde forventet.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Diacomit had shown its effectiveness in SMEI, albeit in studies that were limited and did not last as long as the Committee expected.
Udvalget vurderede, at fordelene ved Diacomit opvejer risiciene ved at anvende det i kombination med clobazam og valproat som tillægsbehandling mod refraktoriske, generaliserede tonisk- kloniske anfald hos patienter med SMEI (eller Dravets syndrom), hvis anfald ikke kan kontrolleres tilstrækkeligt med clobazam og valproat.
It decided that Diacomit’ s benefits are greater than its risks for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with SMEI (or Dravet’ s syndrome) whose seizures are not adequately controlled with clobazam and valproate.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Diacomit.
The Committee recommended that Diacomit be given marketing authorisation.
Der er udstedt ” betinget godkendelse ” for Diacomit.
Diacomit has been given ‘ Conditional Approval’.
Det betyder, at der afventes yderligere dokumentation om lægemidlet.
This means that there is more evidence to come about the medicine.
Hvilke oplysninger afventes der stadig for Diacomit?
What information is still awaited for Diacomit?
Den virksomhed, som fremstiller Diacomit, vil gennemføre en undersøgelse, der skal sammenligne Diacomit og clobazam som tillægsbehandling til børn, hvis symptomer ikke kan kontrolleres tilstrækkeligt med clobazam og valproat.
The company that makes Diacomit will carry out a study comparing Diacomit and clobazam, as an add-on to existing treatment in children whose symptoms are not adequately controlled with clobazam and valproate.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Diacomit?
Which measures are being taken to ensure the safe use of Diacomit?
Virksomheden vil
The company that makes Diacomit will monitor the effects of the medicine on problems with the stomach and gut and on growth rate, particularly when combined with valproate.
2/ 3 også kontrollere, hvilken virkning kombinationen af Diacomit med andre lægemidler har på risikoen for langsigtede problemer i hjernen og nervesystemet.
It will also monitor the effects of combining Diacomit with other medicines on the risk of long-term problems affecting the brain and nervous system.
Andre oplysninger om Diacomit:
Other information about Diacomit:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Diacomit til Biocodex den 4. januar 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Diacomit to Biocodex on 4 January 2007.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme vedrørende Diacomit findes her.
2/ 3 The summary of opinion of the Committee for Orphan Medicinal Products for Diacomit is available here.
Den fuldstændige EPAR for Diacomit findes her.
The full EPAR for Diacomit can be found here.
Lægemiddelform
administration
Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Pulver til oral suspension Pulver til oral suspension Pulver til oral suspension Pulver til oral suspension Pulver til oral suspension Pulver til oral suspension
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Powder for oral suspension Powder for oral suspension Powder for oral suspension Powder for oral suspension Powder for oral suspension Powder for oral suspension
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Flaske (PP) Flaske (PP) Flaske (PP) Flaske (PP) Flaske (PP) Flaske (PP) Brev (papir/ Al/ PE) Brev (papir/ Al/ PE) Brev (papir/ Al/ PE) Brev (papir/ Al/ PE) Brev (papir/ Al/ PE) Brev (papir/ Al/ PE)
Bottle (PP) Bottle (PP) Bottle (PP) Bottle (PP) Bottle (PP) Bottle (PP) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE) Sachet (paper/ Al/ PE)
30 kapsler 60 kapsler 90 kapsler 30 kapsler 60 kapsler 90 kapsler 30 breve 60 breve 90 breve 30 breve 60 breve 90 breve
30 capsules 60 capsules 90 capsules 30 capsules 60 capsules 90 capsules 30 sachets 60 sachets 90 sachets 30 sachets 60 sachets 90 sachets
Hver kapsel indeholder 250 mg stiripentol
Each capsule contains 250 mg of stiripentol
0, 16 mg natrium pr. kapsel
0.16 mg sodium per capsule.
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 kramper ikke behandles tilstrækkeligt med clobazam og valproat.
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.
Diacomit må kun indgives under opsyn af en pædiater/ pædiatrisk neurolog med erfaring i diagnosticering og behandling af epilepsi hos spædbørn og børn.
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.
Kapslen skal sluges hel med et glas vand under måltidet
The capsule should be swallowed whole with a glass of water during a meal.
Dosis af Diacomit beregnes på basis af mg/ kg legemsvægt.
The dose of Diacomit is calculated on a mg/ kg body weight basis.
Påbegyndelsen af adjuverende behandling med Diacomit bør ske over 3 dage med anvendelse af en dosisstigning, så man opnår den anbefalede dosis på 50 mg/ kg/ dag, som indgives sammen med clobazam og valproat.
The initiation of adjunctive therapy with Diacomit should be undertaken over 3 days using upwards dose escalation to reach the recommended dose of 50 mg/ kg/ day administered in conjunction with clobazam and valproate.
Denne anbefalede dosis er baseret på de tilgængelige fund fra kliniske forsøg og var den eneste dosis Diacomit, der blev evalueret i de pivotale forsøg.
This recommended dose is based on the available clinical study findings and was the only dose of Diacomit evaluated in the pivotal studies.
5. 1)
(See, section 5.1)
Der findes ingen kliniske forsøgsdata, der understøtter den kliniske sikkerhed ved Diacomit indgivet i daglige doser over 50 mg/ kg/ dag.
There are no clinical study data to support the clinical safety of Diacomit administered at daily doses greater than 50mg/ kg/ day.
Der findes ingen kliniske forsøgsdata, der understøtter anvendelse af Diacomit som monoterapi til Dravets syndrom.
There are no clinical study data to support the use of Diacomit as monotherapy in Dravet’ s syndrome.
2 Dosisjusteringer af andre antiepileptika, der anvendes i kombination med Diacomit 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 Diacomit.
Dose adjustments of other antiepileptics used in combination with Diacomit 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 Diacomit is provided based on clinical experience.
- Clobazam
- Clobazam
I de pivotale forsøg var den daglige dosis clobazam, da behandlingen med Diacomit blev iværksat, 0, 5 mg/ kg/ dag, hvilket normalt blev indgivet i inddelte doser to gange dagligt.
In the pivotal studies, when the use of Diacomit was initiated, the daily dose of clobazam was 0.5 mg/ kg/ day usually administered in divided doses, twice daily.
I tilfælde af kliniske tegn på bivirkninger eller overdosering af clobazam (dvs. døsighed, hypotoni og irritabilitet hos små børn) blev denne daglige dosis reduceret med 25% hver uge.
In the event of clinical signs of side effects or overdosage of clobazam (i. e., drowsiness, hypotonia, and irritability in young children), this daily dose was reduced by 25% every week.
I forbindelse med ledsagende indgivelse af Diacomit 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.
Approximately two to three fold increases in clobazam and five fold increases in norclobazam plasma levels respectively have been reported with co- administration of Diacomit in children with Dravet’ s syndrome.
Muligheden for metabolisk interaktion mellem Diacomit og valproat anses for at være moderat, og der bør derfor ikke være behov for ændring af doseringen af valproat, når Diacomit tilføjes, medmindre det sker af hensyn til den kliniske sikkerhed.
The potential for metabolic interaction between Diacomit and valproate is considered modest and thus, no modification of valproate dosage should be needed when Diacomit is added, except for clinical safety reasons.
4. 4).
Abnormal Laboratory Findings In the event of an abnormal blood count or liver function test finding, the clinical decision for continuing use or adjusting the dose of Diacomit 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).
Virkninger af madvarer Diacomit skal altid tages sammen med mad, da det nedbrydes hurtigt i et syreholdigt miljø (fx eksponering for mavesyre på tom mave).
Effects of food Diacomit must always be taken with food as it degrades rapidly in an acidic environment (e. g. exposure to gastric acid in an empty stomach).
Diacomit må ikke tages sammen med mælk eller andre mejeriprodukter (youghurt, smøreoste osv.), kulsyreholdige drikkevarer, frugtjuice eller mad eller drikkevarer, der indeholder koffein eller theophyllin.
Diacomit 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.
Virkninger af formuleringen Formuleringen i brevene har en lidt højere Cmax end kapslerne, og derfor har formuleringerne ikke den samme bioækvivalens.
Effect of formulation The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not bioequivalent.
Hvis det er nødvendigt at skifte mellem de to formuleringer, anbefales det at gøre det under klinisk supervision i tilfælde af toleranceproblemer (se afsnit 5. 2).
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).
Børn under 3 år:
Children aged less than 3 years:
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.
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.
5. 1).
In this younger group of patients, adjunctive therapy with Diacomit should only be started when the diagnosis of SMEI has been clinically confirmed (See, section 5.1).
Data vedrørende anvendelse af Diacomit til børn under 12 måneder er begrænsede.
Data are limited about the use of Diacomit under 12 months of age.
4. 4).
Patients with renal and hepatic impairment Diacomit is not recommended for use in patients with impaired hepatic and/ or renal function (See, section 4.4)
Carbamazepin, phenytoin og phenobarbital bør ikke anvendes sammen med Diacomit i behandlingen af Dravets syndrom.
Carbamazepine, iphenytoin and phenobarbital should not be used in conjunction with Diacomit in the management of Dravet’ s syndrome.
4. 2).
The daily dosage of clobazam and/ or valproate should be reduced according to the onset of side effects whilst on Diacomit therapy (See, section 4.2).
I betragtning af hyppigheden af gastrointestinale bivirkninger ved behandlingen med Diacomit og valproat (anoreksi, appetitløshed, nausea, opkastning), bør vækstraten hos børn i denne behandlingskombination overvåges nøje.
Given the frequency of gastrointestinal adverse reactions to treatment with Diacomit and valproate (anorexia, loss of appetite, nausea, vomiting), the growth rate of children under this combination of treatment should be carefully monitored.
Der kan opstå neutropeni i forbindelse med indgivelsen af Diacomit, clobazam og valproat.
Neutropenia may be associated with the administration of Diacomit, clobazam and valproate.
Der bør derfor foretages vurderinger af blodtællinger, inden behandlingen med Diacomit påbegyndes.
Blood counts should be assessed prior to starting treatment with Diacomit.
Blodtællingerne bør kontrolleres hver 6. måned, medmindre andet er klinisk indiceret.
Unless otherwise clinically indicated, blood counts should be checked every 6 months..
Leverfunktionen bør vurderes, inden behandlingen med Diacomit påbegyndes.
Liver function should be assessed prior to starting treatment with Diacomit.
Hvis specifikke kliniske data for patienter med svækket lever - eller nyrefunktion mangler, frarådes det at anvende Diacomit til patienter med svækket lever - og/ eller nyrefunktion.
In the absence of specific clinical data in patients with impaired hepatic or renal function, Diacomit is not recommended for use in patients with impaired hepatic and/ or renal function.
4. 5.).
Stiripentol is an inhibitor of the enzymes CYP2C19, CYP3A4 and CYP2D6 and may markedly increase the plasma concentrations of drugs metabolised by these enzymes and increase the risk of adverse effects (See, section 4.5.).
Det tilrådes at udvise forsigtighed, når stiripentol kombineres med andre lægemidler, som hæmmer eller inducerer en eller flere af disse enzymer.
Caution is advised when combining stiripentol with other drugs that inhibit or induce one or more of these enzymes..
Potentielle lægemiddelinteraktioner, der påvirker stiripentol Andre antiepileptiske præparaters påvirkning af farmakokinetikken for stiripentol er ikke fastlagt nøje.
Potential medicinal product interactions affecting stiripentol The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well established.
Det tilrådes at udvise forsigtighed, når stiripentol kombineres med andre lægemidler, som hæmmer eller inducerer en eller flere af disse enzymer.
Caution is advised when combining stiripentol with other drugs that inhibit or induce one or more of these enzymes
Virkningen af stiripentol på cytochrom P450- enzymer.
Effect of stiripentol on cytochrome P450 enzymes.
Stigningen i steady state- niveauerne ved den kombinerede anvendelse af Diacomit, valproat og clobazam er ens hos voksne og børn, om end variationen fra person til person er udtalt.
The increase in steady state levels with the combined use of Diacomit, valproate, and clobazam is similar in adults and children, though inter-individual variability is marked.
I terapeutiske koncentrationer hæmmer stiripentol markant mindst to CYP450- isoenzymer: for eksempel CYP2C19, CYP2D6 og CYP3A4.
At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for example, CYP2C19, CYP2D6 and CYP3A4.
Disse interaktioner kan medføre forhøjede systemiske
These interactions may result in increased systemic levels of these active substances that may lead to enhanced pharmacological effects and to an increase in side effects and adverse reactions.
4 niveauer af disse aktive stoffer, som kan føre til forstærkede farmakologiske effekter og til en stigning i bivirkniger og uønskede hændelser.
Caution must be exercised if clinical circumstances require combining stiripentol with drugs metabolised by CYP2C19 (e. g. citalopram, omeprazole) or CYP3A4 (e. g.
På grund af den øgede risiko for bivirkninger (se yderligere i dette afsnit vedrørende antiepileptiske midler) skal udvises forsigtighed, hvis de kliniske omstændigheder kræver, at stiripentol kombineres med præparater, der metaboliseres af CYP2C19 (fx citalopram, omeprazol) eller CYP3A4 (fx HIV - proteasehæmmere, antihistaminer såsom astemizol, chlorpheniramin, calciumkanalblokkere, statiner, orale antikonceptionsmidler, codein).
HIV protease inhibitors, antinistamines such as astemizole, chlorpheniramine, calcium channel blockers, statins, oral 4 contraceptives, codeine) due to the increased risk of adverse events (see further in this section for antiepileptic drugs).
Det anbefales at overvåge plasmakoncentrationerne eller bivirkningerne.
Monitoring of plasma concentrations or adverse effects is recommended.