FrancophonIA/ELRC3.0 huggingface dataset:
English: The doctor will check your child's visual field before your child starts taking vigabatrin and carry on checking it at regular intervals during the treatment.
Danish: Lægen vil tjekke dit barns synsfelt, før vigabatrinbehandlingen påbegyndes og med regelmæssige mellemrum under behandlingen.
English: Suicidal ideation and behaviour
Danish: Selvmordstanker og selvmordsadfærd
English: Patients with myoclonic seizures may be particularly susceptible to this effect.
Danish: Patienter med myokloniske krampeanfald kan være særligt følsomme over for denne bivirkning.
English: Maintenance recommendations in relation to bodyweight are: Bodyweight:
Danish: Anbefalet vedligeholdelsesdosis i henhold til legemsvægt er: Legemsvægt:
English: Kigabeq contains vigabatrin and it is used for treating infants and children aged from 1 month to less than 7 years.
Danish: Kigabeq indeholder vigabatrin og anvendes til behandling af spædbørn og børn i alderen 1 måned op til mindre end 7 år.
English: A small number of people being treated with epilepsy medicines such as vigabatrin have had thoughts of harming or killing themselves.
Danish: Et lille antal patienter, der har fået epilepsimedicin som f.eks. vigabatrin, har haft tanker om at gøre skade på sig selv eller begå selvmord.
English: Frequencies found in an open clinical study are presented in section 4.8.
Danish: De hyppigheder, der blev observeret i et åbent klinisk studie, er anført i pkt.
English: For children aged 1 month to less than 7 years
Danish: Til børn i alderen 1 måned op til mindre end 7 år
English: Plasma and cerebrospinal fluid concentrations are linearly related to dose over the recommended dose range.
Danish: Koncentrationen i plasma og cerebrospinalvæske er lineært relateret til dosis over det anbefalede dosisinterval.
English: Subsequent dosing can be titrated by 25 mg/kg/day increments every 3 days up to the maximum recommended dose of 150 mg/kg/day.
Danish: Efterfølgende kan doseringen titreres i trin af 25 mg/kg/dag hver 3. dag op til den maksimalt anbefalede dosis på 150 mg/kg/dag.
English: Your child should not ride a bicycle, climb or take part in hazardous activity if the child has symptoms like drowsiness or dizziness with Kigabeq.
Danish: Dit barn må ikke køre på cykel, klatre eller deltage i risikobetonede aktiviteter, hvis han/hun har symptomer som f.eks. døsighed eller svimmelhed under behandling med Kigabeq.
English: Visual disorders, which can affect the ability to cycle, climb or take part in hazardous activity, have occurred in some patients taking this medicine.
Danish: Synsforstyrrelser, der kan påvirke evnen til at cykle, klatre eller deltage i risikobetonede aktiviteter, er observeret hos nogle patienter under behandling med dette lægemiddel.
English: Vigabatrin is eliminated via renal excretion with a terminal half-life of 5-8 hours.
Danish: Vigabatrin elimineres via udskillelse gennem nyrerne med en terminal halveringstid på 5-8 timer.
English: Table 2: Number of soluble tablets according to body weight and starting dose in resistant partial epilepsy
Danish: Tabel 2: Antal opløselige tabletter i henhold til legemsvægt og startdosis ved resistent partiel epilepsi
English: The magnitude of suppression for ALT has been reported to vary between 30% and 100%.
Danish: Omfanget af supprimering af ALAT er ifølge rapporter 30-100 %.
English: If your child has kidney problems, the doctor may prescribe a smaller dose.
Danish: Hvis dit barn har nyreproblemer, vil lægen ordinere en mindre dosis.
English: Tablets are disintegrated in approximately 5 or 10 ml of water and the resulting solution is introduced into the tube using an adapted syringe.
Danish: Tabletterne opløses i ca. 5-10 ml vand, og opløsningen sprøjtes ind i sonden ved hjælp af en egnet sprøjte.
English: If a patient is to be withdrawn from vigabatrin treatment, it is recommended that this is done by gradual dose reduction over a 2- to 4-week period.
Danish: Hvis en patient skal have seponeret vigabatrin-behandling, anbefales det, at det gøres ved gradvis dosisreduktion over 2-4 uger.
English: Animal experiments have shown that vigabatrin has no negative influence on fertility or pup development.
Danish: Dyreforsøg har vist, at vigabatrin ikke har nogen negativ indflydelse på fertiliteten eller afkommets udvikling.
English: ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 PARIS France
Danish: ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 Paris
English: • If the child cannot swallow, the mixture can be given through a gastric tube, using a suitable syringe.
Danish: • Hvis dit barn ikke kan synke, kan blandingen indgives via en mavesonde med en egnet sprøjte.
English: Laboratory data indicate that vigabatrin treatment does not lead to renal toxicity.
Danish: Laboratoriedata indikerer, at vigabatrin-behandling ikke medfører renal toksicitet.
English: Always give this medicine to your child exactly as the doctor has told you.
Danish: Giv altid dette lægemiddel til dit barn nøjagtigt efter lægens anvisning.
English: Chronic treatment with vigabatrin may be associated with a slight decrease in haemoglobin which rarely attains significance.
Danish: Kronisk behandling med vigabatrin kan være forbundet med et lille fald i hæmoglobin, der sjældent er signifikant.
English: For younger patients electroretinography should be used (see Visual Field Defects).
Danish: Hos yngre patienter bør elektroretinografi anvendes (se Synsfeltsdefekter).
English: Dissolution of soluble tablet
Danish: Opløsning af den opløselige tablet
English: It is used to treat infantile spasms (West's syndrome) or, together with other epilepsy medicines to treat partial epilepsy that is not controlled well enough with current treatment.
Danish: Det anvendes til behandling af infantile spasmer (Wests syndrom) eller, sammen med andre lægemidler mod epilepsi, til behandling af partiel epilepsi, der ikke kontrolleres tilstrækkeligt med den gængse medicin.
English: Vigabatrin should be used with caution in patients with a history of psychosis, depression or behavioural problems.
Danish: Vigabatrin bør bruges med forsigtighed hos patienter med tidligere psykose, depression eller adfærdsproblemer.
English: Based on the available data the first oscillatory potential and 30 Hz flicker responses of the electroretinogram appear to be correlated with a vigabatrin associated VFD.
Danish: Baseret på tilgængelige data synes elektroretinogrammets første oscillatoriske potentiale og 30 Hzflickerresponser at være korreleret med en vigabatrin-associeret synsfeltsdefekt.
English: Patients should undergo systematic screening examination when starting vigabatrin and at regular intervals for detection of visual field defects.
Danish: Patienterne bør gennemgå en systematisk screeningsundersøgelse, når de starter på vigabatrin, og derefter med regelmæssige intervaller med henblik på opdagelse af synsfeltsdefekter.
English: If your child develops symptoms like sleepiness, reduced consciousness and movements (stupor) or confusion, tell your child's doctor who may reduce the dose or stop Kigabeq treatment.
Danish: Hvis dit barn udvikler symptomer som f.eks. søvnighed, nedsat bevidstheds- og bevægelsesniveau (sløvhed) eller forvirring, skal du sige det til lægen, der så kan nedsætte dosen eller standse Kigabeqbehandlingen.
English: Food administration does not alter the extent of vigabatrin absorption.
Danish: Indtagelse samtidig med mad ændrer ikke omfanget af vigabatrin-absorption.
English: The parents and/or caregivers must be given a thorough description of the frequency and implications of the development of VFD during vigabatrin treatment.
Danish: Forældrene og/eller omsorgspersonerne skal have en grundig beskrivelse af hyppigheden og følgerne af udvikling af synsfeltsdefekter under behandlingen med vigabatrin.
English: There is no relevant use of Kigabeq in neonates (below 27 days of age) in the indication “infantile spasms” and in children and adolescents above 7 years of age in the indication “resistant partial epilepsy” (focal onset seizures).
Danish: Der er ingen relevant brug af Kigabeq hos nyfødte (under 27 dage gamle) i indikationen infantile spasmer eller hos børn og unge i alderen 7 år og opefter i indikationen resistent partiel epilepsi (fokale anfald).
English: The clinical significance of these MRI abnormalities is unknown.
Danish: Den kliniske relevans af disse anomalier er ikke kendt.
English: This efficacy is particularly marked in patients with seizures of partial origin.
Danish: Denne virkning er særlig udtalt hos patienter med krampeanfald af partiel karakter.
English: When reported, the most common symptoms included drowsiness or coma.
Danish: I de tilfælde, hvor det er oplyst, var de hyppigste symptomer døsighed eller koma.
English: Controlled and long-term clinical trials have shown that vigabatrin is an effective anticonvulsant agent when given as first line treatment in patients with infantile spasms and as add-on therapy in patients with epilepsy not controlled satisfactorily by conventional therapy.
Danish: Kontrollerede og længerevarende kliniske studier har vist, at vigabatrin er et effektivt krampestillende stof, når det gives som førstelinjebehandling hos patienter med infantile spasmer og som tillægsbehandling hos patienter med epilepsi, der ikke er tilstrækkeligt kontrolleret med konventionel behandling.
English: Vigabatrin may increase the amount of amino acids in the urine possibly leading to a false positive test for certain rare genetic metabolic disorders (e.g., alpha aminoadipic aciduria).
Danish: Vigabatrin kan øge mængden af aminosyrer i urinen, hvilket kan medføre en falsk-positiv test for visse sjældne genetiske stofskiftesygdomme (f.eks. alpha aminoadipic aciduria).
English: - Observed at inclusion - Observed at first conclusive evaluation - Observed at last conclusive evaluation
Danish: Synsfeltsdefekt med ikkeidentificeret ætiologi: - Observeret ved inklusion - Observeret ved første konklusive vurdering - Observeret ved sidste konklusive vurdering
English: Not known (frequency cannot be estimated from the available data) movement disorders and abnormalities in magnetic resonance imaging (MRI) brain scans in young infants treated for infantile spasms
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data) bevægeforstyrrelser og unormale resultater ved MR-scanning (magnetisk resonans) af hjernen hos små spædbørn, der behandles for infantile spasmer
English: Studies with vigabatrin revealed no evidence of mutagenic or carcinogenic effects.
Danish: Forsøg med vigabatrin har ikke vist tegn på mutagene eller karcinogene virkninger.
English: Do not stop giving this medicine without talking to your child's doctor.
Danish: Du må ikke holde op med at give dette lægemiddel til dit barn uden at tale med lægen.
English: The following table gives the number of Kigabeq tablets to give to your child according to the dose prescribed by your child's doctor.
Danish: Nedenstående tabel angiver det antal Kigabeq-tabletter, som du skal give dit barn i overensstemmelse med den lægeordinerede dosis.
English: Decreases in ALT and AST, which are considered to be a result of inhibition of these aminotransferases by vigabatrin, have been observed.
Danish: Fald i ALAT og ASAT, der menes at være et resultat af vigabatrins hæmning af disse aminotransferaser, er observeret.
English: If at any time your child has had these symptoms, immediately contact child's doctor.
Danish: Hvis dit barn på noget tidspunkt har haft disse symptomer, skal du straks kontakte lægen.
English: Visual field defects which can significantly affect the ability to perform hazardous activities have been frequently reported in association with vigabatrin.
Danish: Synsfeltsdefekter, der i væsentlig grad kan påvirke evnen til at udføre farlige aktiviteter, er hyppigt rapporteret i forbindelse med vigabatrin-behandling.
English: Depression was a common psychiatric reaction in clinical trials but seldom required discontinuation of vigabatrin.
Danish: Depression var en almindelig psykisk reaktion i kliniske studier, men krævede kun i sjældne tilfælde seponering af behandlingen.
English: Vigabatrin may lead to a decrease in measured plasma activity of alanine aminotransferase (ALT) and to a lesser extent, aspartate aminotransferase (AST).
Danish: Vigabatrin kan medføre et fald i den målte plasmaaktivitet af alaninaminotransferase (ALAT) og i mindre grad af aspartataminotransferase (ASAT).
English: Rare reports of encephalopathic symptoms such as marked sedation, stupor and confusion in association with non-specific slow wave activity on electroencephalogram have been described soon after the initiation of vigabatrin treatment.
Danish: Sjældne tilfælde af encefalopatiske symptomer som f.eks. udtalt sedation, stupor og konfusion i forbindelse med non-specifik langsom bølgeaktivitet på elektroencefalogram er rapporteret kort efter påbegyndelse af behandling med vigabatrin.
English: Movement disorders can occur in young infants treated for infantile spasms (West's syndrome).
Danish: Der kan ses bevægeforstyrrelser hos små spædbørn, der behandles for infantile spasmer (Wests syndrom).
English: Therefore, these liver tests may be quantitatively unreliable in patients taking vigabatrin (see section 4.8).
Danish: Derfor kan disse levertest være kvantitativt upålidelige hos patienter, der tager vigabatrin (se pkt.
English: 0.5 x 100 mg tablet morning 0.5 x 100 mg tablet evening 0.5 x 100 mg tablet morning 1 x 100 mg tablet evening 1 x 100 mg tablet morning 1 x 100 mg tablet evening 1 x 100 mg tablet morning 1.5 x 100 mg tablet evening 1.5 x 100 mg tablet morning 1.5 x 100 mg tablet evening 1.5 x 100 mg tablet morning 2 x 100 mg tablet evening 2 x 100 mg tablet morning 2 x 100 mg tablet evening 2.5 x 100 mg tablet morning 2.5 x 100 mg tablet evening 3 x 100 mg tablet morning 3 x 100 mg tablet evening 3.5 x 100 mg tablet morning 3.5 x 100 mg tablet evening 3.5 x 100 mg tablet morning 4 x 100 mg tablet evening 4.5 x 100 mg tablet morning 4.5 x 100 mg tablet evening 1 x 500 mg tablet morning 1 x 500 mg tablet evening 1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening 30 1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
Danish: 0,5 x 100 mg-tablet (morgen) 0,5 x 100 mg-tablet (aften) 0,5 x 100 mg-tablet (morgen) 1 x 100 mg-tablet (aften) 1 x 100 mg-tablet (morgen) 1 x 100 mg-tablet (aften) 1 x 100 mg-tablet (morgen) 1,5 x 100 mg-tablet (aften) 1,5 x 100 mg-tablet (morgen) 1,5 x 100 mg-tablet (aften) 1,5 x 100 mg-tablet (morgen) 2 x 100 mg-tablet (aften) 2 x 100 mg-tablet (morgen) 2 x 100 mg-tablet (aften) 2,5 x 100 mg-tablet (morgen) 2,5 x 100 mg-tablet (aften) 3 x 100 mg-tablet (morgen) 3 x 100 mg-tablet (aften) 3,5 x 100 mg-tablet (morgen) 3,5 x 100 mg-tablet (aften) 3,5 x 100 mg-tablet (morgen) 4 x 100 mg-tablet (aften) 4,5 x 100 mg-tablet (morgen) 4,5 x 100 mg-tablet (aften) 1 x 500 mg-tablet (morgen) 1 x 500 mg-tablet (aften) 1 x 500 mg-tablet (morgen) 1 x 500 mg- og 1 x 100 mg-tablet (aften) 30 1 x 500 mg- og 1 x 100 mg-tablet (morgen) 1 x 500 mg- og 1 x 100 mg-tablet (aften)
English: Rarely seen events include suicide attempts, encephalopathy and retinal disorders.
Danish: Sjældne bivirkninger omfatter selvmordsforsøg, encefalopati og nethindesygdomme.
English: This is normal and due to presence of water-insoluble excipients.
Danish: Dette er normalt og skyldes tilstedeværelsen af hjælpestoffer, der ikke opløses i vand.
English: No teratogenicity was seen in rats in doses up to 150 mg/kg (3 times the human dose) or in rabbits in doses up to 100 mg/kg.
Danish: Det er ikke teratogent hos rotter ved doser op til 150 mg/kg (3 gange human dosis) eller hos kaniner ved doser op til 100 mg/kg.
English: If a visual field constriction is observed during follow-up, consideration should be given to gradual discontinuation of vigabatrin.
Danish: Hvis en synsfeltskonstriktion observeres under opfølgningen, bør en gradvis seponering af vigabatrin overvejes.
English: Vigabatrin can cause permanent vision loss.
Danish: Vigabatrin kan medføre permanent synstab.
English: Such changes have not been seen in vigabatrin treated patients without a VFD.
Danish: Sådanne ændringer er ikke set hos vigabatrinbehandlede patienter uden en synsfeltsdefekt.
English: Skin and subcutaneou s tissue disorders rash angioede ma, urticaria
Danish: Hud og subkutane væv udslæt angioøde m, urticaria
English: The assessment must be continued 6 to 12 months after the discontinuation of therapy.
Danish: Vurderingen bør fortsættes 6-12 måneder efter behandlingsophør.
English: If the doctor decides to stop the treatment you will be advised to gradually reduce the dose.
Danish: Hvis lægen vurderer, at behandlingen skal standses, vil du blive bedt om at reducere dosen gradvist.
English: However, during controlled clinical studies, a gradual reduction of 16-33% in the plasma concentration of phenytoin has been observed.
Danish: Der er imidlertid observeret en gradvis reduktion på 16-33 % i plasmakoncentrationen af phenytoin i kontrollerede kliniske studier.
English: Wait until the tablet(s) fully disintegrate; tablets generally disintegrate in less than one minute but disintegration can be fastened by gently hand stirring the oral solution.
Danish: Vent, indtil tabletten/tabletterne er fuldt opløst; tabletterne opløses typisk på mindre end et minut, men processen kan fremskyndes ved at omrøre forsigtigt.
English: In view of the fact that drowsiness has been observed in clinical trials with vigabatrin, patients should be warned of this possibility at the start of treatment.
Danish: I lyset af, at der i kliniske studier af vigabatrin er observeret døsighed, bør patienterne advares om denne bivirkning ved påbegyndelse af behandlingen.
English: Kigabeq is available as 100 mg or 500 mg tablets which can be given together to make up the right dose for your child.
Danish: Kigabeq fås som 100 mg- eller 500 mg-tabletter, der kan kombineres for at opnå den rette dosis til dit barn.
English: If this happens, contact your child's doctor immediately.
Danish: Hvis det sker, skal du kontakte lægen med det samme.
English: It is usually detected after months or years of treatment with vigabatrin.
Danish: Det opdages typisk efter måneders eller års behandling med vigabatrin.
English: This visual field loss may be severe and permanent, so it must be detected early to avoid progression.
Danish: Der kan være tale om et alvorligt og varigt tab af synsfelt, så det skal opdages hurtigt for at undgå, at det forværres.
English: Available data suggests that visual field defects are irreversible even after discontinuation of vigabatrin.
Danish: Tilgængelige data peger på, at synsfeltsdefekter er irreversible, selv efter seponering af vigabatrin.
English: Vigabatrin is a selective irreversible inhibitor of GABA transaminase, the enzyme responsible for the breakdown of GABA (gamma aminobutyric acid).
Danish: Vigabatrin er en selektiv irreversibel hæmmer af GABA-transaminase, der er det enzym, som står for nedbrydningen af GABA (gammaaminosmørsyre).
English: N=150 N=151 N=97
Danish: Gruppe II4 Gruppe III N = 38 N = 47 N = 41 N = 150 N = 151 N = 97
English: 0.5 to 1 g/day
Danish: 0,5-1 g/dag
English: Some patients may experience an increase in seizure frequency, including status epilepticus with vigabatrin.
Danish: Nogle patienter kan opleve en stigning i hyppigheden af krampeanfald, herunder status epilepticus, ved behandling med vigabatrin.
English: Vigabatrin is not recommended for use in patients with any pre-existing clinically significant visual field defect.
Danish: Vigabatrin anbefales ikke hos patienter med eksisterende, klinisk signifikante synsfeltsdefekter.
English: These side effects usually stop when doses are reduced or the medicine is gradually discontinued.
Danish: Disse bivirkninger fortager sig normalt, når doserne reduceres eller lægemidlet gradvist udtrappes.
English: Movement disorders including dystonia, dyskinesia and hypertonia, have been reported in patients treated with vigabatrin for infantile spasms.
Danish: Bevægeforstyrrelser, herunder dystoni, dyskinesi og hypertoni, er rapporteret hos patienter, der er blevet behandlet med vigabatrin mod infantile spasmer.
English: The mean Cl/F of active S-enantiomer of vigabatrin in infants and children was 0.591 l/h/kg and 0.446 l/h/kg respectively.
Danish: Den gennemsnitlige clearance (Cl/F) af aktiv S-enantiomer af vigabatrin hos spædbørn og børn var hhv. 0,591 l/t/kg og 0,446 l/t/kg.
English: In both rat and dog they were reversible on stopping vigabatrin treatment and even regressed with continued treatment.
Danish: Hos både rotter og hunde var de reversible ved seponering af vigabatrin-behandling og blev desuden mindre ved fortsat behandling.
English: Talk to your child's doctor before you give Kigabeq if your child: has or has had depression or any other psychiatric illness in the past has had any kidney problems as he/she could develop symptoms like sedation or confusion has had any eye problems.
Danish: Kontakt lægen eller apotekspersonalet, før du giver dit barn Kigabeq, hvis dit barn: - har eller tidligere har haft en depression eller anden psykisk lidelse - har haft nyreproblemer (da dit barn kan udvikle symptomer som søvnighed eller forvirring) - har haft problemer med øjnene.
English: If new movement disorders occur during treatment with vigabatrin, consideration should be given to dose reduction or a gradual discontinuation of treatment.
Danish: Hvis nye bevægeforstyrrelser kommer til under behandlingen med vigabatrin, bør det overvejes at reducere dosis eller gradvist seponere behandlingen.
English: Vigabatrin overdose has been reported.
Danish: Der er rapporteret om overdosering af vigabatrin.
English: Animal safety studies carried out in the rat, mouse, dog and monkey have indicated that vigabatrin has no significant adverse reactions on the liver, kidney, lung, heart or gastrointestinal tract.
Danish: De sikkerhedsmæssige dyrestudier, der er gennemført hos rotter, mus, hunde og aber, har vist, at vigabatrin ikke medfører nogen signifikante bivirkninger relateret til lever, nyrer, lunger, hjerte eller mave-tarm-kanalen.
English: However, in rabbits, a slight increase in the incidence of cleft palate at doses of 150-200 mg/kg was seen.
Danish: Derimod er der set en svag stigning i forekomsten af ganespalte hos kaniner ved doser på 150-200 mg/kg.
English: The tablet can be cut into equal halves.
Danish: Tabletten kan deles i to lige store dele.
English: 1 to 1.5 g/day
Danish: 1-1,5 g/dag
English: • Rinse the glass or beaker with one or two teaspoonfuls (about 5 to 10 ml) of water and give this to your child to make sure that the child receives all the medicine
Danish: • Skyl glasset eller målebægeret med 1-2 teskefulde vand (ca. 5-10 ml), og giv det til dit barn, så det sikres, at han/hun får al medicinen
English: Vigabatrin is not significantly metabolised.
Danish: Biotransformation Vigabatrin bliver ikke i signifikant grad metaboliseret.
English: 10, rue Bouché Thomas ZAC d'Orgemont F-49000 Angers France
Danish: 10, rue Bouché Thomas ZAC d'Orgemont F-49000 Angers 49000 Angers Frankrig
English: Once the child has entirely drunk the medicine solution, the drinking glass should be rinsed with one or two teaspoons of water (approximately 5 or 10 ml) and dispensed to the child by the same way.
Danish: Når barnet har drukket hele opløsningen, bør glasset skylles med 1-2 teskefulde vand (ca. 5-10 ml), som derefter gives til barnet på samme måde.
English: Childre n Do not give this medicine to children less than 1 month of age or more than 7 years of age.
Danish: Giv ikke dette lægemiddel til børn i alderen under 1 måned eller over 7 år.
English: Proposed doses for second titration step (100 mg/kg/day) (Day 6)
Danish: Foreslåede doser til andet titreringstrin (100 mg/kg/dag) (dag 6)
English: These patients should be monitored closely for undesirable effects such as sedation and confusion (see section 4.2).
Danish: Disse patienter bør overvåges nøje for bivirkninger som f.eks. sedation og konfusion (se pkt.
English: Kigabeq is for oral or gastric administration twice daily and may be taken before or after meals.
Danish: Kigabeq er til oral eller gastrisk administration to gange dagligt og kan tages før eller efter et måltid.