FrancophonIA/ELRC3.0 huggingface dataset:
English: The exact nature of this interaction is presently not understood, however, in the majority of cases it is unlikely to be of therapeutic significance.
Danish: Den nøjagtige karakter af denne interaktion er ikke klarlagt, men det er i langt de fleste tilfælde usandsynligt, at den er af terapeutisk betydning.
English: Kigabeq has major influence on the ability to perform hazardous activities.
Danish: Kigabeq kan i væsentlig grad påvirke evnen til at udføre farlige aktiviteter.
English: How to give this medicine
Danish: Sådan skal du give dette lægemiddel
English: A possible association between the risk of visual field defects and the extent of vigabatrin exposure, both in terms of daily dose (from 1 gram to more than 3 grams) and in terms of duration of treatment (maximum during the first three years) has been shown in this study.
Danish: En mulig sammenhæng mellem risikoen for synsfeltsdefekter og omfanget af vigabatrin-eksponering, både hvad angår den daglige dosis (fra 1 g til mere end 3 g) og behandlingsvarighed (maksimal i løbet af de første tre år), er blevet påvist i dette studie.
English: Binding to plasma proteins is negligible.
Danish: Bindingen til plasmaproteiner er ubetydelig.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIGE IDENTIFIKATORER - MENNESKELIGT LÆSBARE DATA
English: In the monkey these lesions are minimal or equivocal.
Danish: Hos aber er disse læsioner minimale eller uklare.
English: The risks of treatment must be very carefully weighed against possible benefit in children.
Danish: Risiciene ved behandling af børn skal afvejes omhyggeligt op mod den mulige fordel.
English: Gastric administration
Danish: Gastrisk administration
English: The mechanism of this effect is not known and the available data do not exclude the possibility of an increased risk for vigabatrin.
Danish: Virkningsmekanismen bag dette er ikke kendt, og de tilgængelige data udelukker ikke muligheden for en øget risiko ved vigabatrin.
English: Approximately 70% of a single oral dose was recovered as unchanged drug in the urine in the first 24 hours post-dose.
Danish: Ca. 70 % af en oral enkeltdosis blev genfundet som uomdannet stof i urinen i løbet af de første 24 timer efter administration.
English: Based on available data, the usual pattern is a concentric constriction of the visual field of both eyes, which is generally more marked nasally than temporally.
Danish: Baseret på tilgængelige data er det sædvanlige mønster en koncentrisk konstriktion af synsfeltet på begge øjne, hvilket generelt er mere udtalt nasalt end temporalt.
English: Therefore, vigabatrin should only be used after careful benefit/ risk assessment compared with alternatives.
Danish: Derfor bør vigabatrin kun anvendes efter en omhyggelig vurdering af benefit/risk-forholdet sammenholdt med eventuelle alternativer.
English: Adolescents and adults (>12 years old)
Danish: Unge og voksne (over 12 år)
English: • Wait until the tablet has broken down completely.
Danish: • Vent, indtil tabletten/tabletterne er helt opløst.
English: Risk of medication error
Danish: Risiko for fejlmedicinering
English: Most of the patients with perimetry-confirmed defects have been asymptomatic.
Danish: De fleste patienter med perimetri-bekræftede defekter har været asymptomatiske.
English: New onset myoclonus and exacerbation of existing myoclonus may occur in rare cases.
Danish: Nye tilfælde af myoklonier og forværring af eksisterende myoklonier kan forekomme i sjældne tilfælde.
English: Neurologic and psychiatric conditions
Danish: Neurologiske og psykiske tilstande
English: Pharmacotherapeutic group: Antiepileptics, fatty acid derivatives, ATC code: N03AG04
Danish: Farmakoterapeutisk klassifikation: Antiepileptica, fedtsyre-derivater; ATC-kode: N03AG04
English: This is normal and the cloudiness is because the tablet contains some non-active ingredients that do not dissolve completely
Danish: Det er helt normalt, og det grumsede udseende skyldes, at tabletten indeholder nogle ikke-aktive ingredienser, som ikke opløses helt
English: Dose (mg per day)
Danish: Dosis (mg pr. dag)
English: Read all of this leaflet carefully before you give this medicine to your child because it contains important information.
Danish: Læs denne indlægsseddel grundigt, inden du giver dette lægemiddel dit barn, da den indeholder vigtige oplysninger.
English: This takes less than a minute but you can speed it up by stirring the mixture gently by hand
Danish: Det tager under et minut, men du kan fremskynde processen ved at omrøre blandingen forsigtigt
English: Patients were split in three treatment groups: patients currently treated with vigabatrin (group I), patients previously exposed to vigabatrin (group II) and patients never exposed to vigabatrin (group III).
Danish: Patienterne blev opdelt i tre behandlingsgrupper: patienter i aktuel behandling med vigabatrin (gruppe I), patienter, der tidligere har været eksponeret for vigabatrin (gruppe II), og patienter, der aldrig har været eksponeret for vigabatrin (gruppe III).
English: In the central visual field (within 30 degree of eccentricity), frequently an annular nasal defect is seen.
Danish: I det centrale synsfelt (inden for 30 graders excentricitet) ses der ofte en ringformet nasal defekt.
English: The changes in the visual field may be permanent, so it is important to detect them early to avoid progression .
Danish: Ændringerne i synsfeltet kan være varige, så det er vigtigt at opdage dem tidligt for at undgå, at de forværres.
English: Perimetry is seldom possible in children less than 9 years of developmental age.
Danish: Perimetri er sjældent mulig hos børn med en udviklingsalder under 9 år.
English: This medicine should be used within 100 days after first opening.
Danish: Dette lægemiddel skal bruges inden for 100 dage efter anbrud.
English: You must speak to your child's doctor if your child's condition does not improve within a month of starting vigabatrin.
Danish: Du skal tale med lægen, hvis dit barns tilstand ikke bedres inden for en måned efter påbegyndelse af vigabatrin-behandling.
English: No metabolites have been identified in plasma.
Danish: Der er ikke fundet metabolitter i plasma.
English: Hence, this undesirable effect can only be reliably detected by systematic perimetry which is usually possible only in patients with a developmental age of more than 9 years.
Danish: Denne bivirkning kan kun opdages på pålidelig vis ved hjælp af systematisk perimetri, der typisk kun er mulig hos patienter med en udviklingsalder på mere end 9 år.
English: If the decision to continue treatment is made, consideration should be given to more frequent follow-up (perimetry) in order to detect progression or sight threatening defects.
Danish: Hvis det besluttes at fortsætte behandlingen, bør hyppigere opfølgning (perimetri) overvejes med henblik på at opdage progression eller defekter, der truer synet.
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviour, and appropriate treatment should be considered.
Danish: Patienterne bør derfor overvåges for tegn på selvmordstanker og selvmordsadfærd, og relevant behandling bør overvejes.
English: Since no stability studies have been performed with other solvents than water, for preparing oral solution only water should be used.
Danish: Da der ikke er udført nogen stabilitetsstudier med andre solvenser end vand, bør en oral opløsning kun klargøres med vand.
English: Currently, there is no established method to diagnose or exclude visual field defects in children in whom a standardised perimetry cannot be performed.
Danish: Der er i øjeblikket ingen fastlagt metode til diagnosticering eller udelukkelse af synsfeltsdefekter hos børn, hvor en standardiseret perimetri ikke kan udføres.
English: These phenomena may also be the consequence of an overdose, a decrease in plasma concentrations of concomitant antiepileptic treatment, or a paradoxical effect.
Danish: Disse fænomener kan også være konsekvensen af en overdosis, et fald i plasmakoncentrationen af et samtidigt antiepileptisk lægemiddel eller en paradoksal effekt.
English: When the tablets are fully disintegrated, the whole content of solution should be administered straight away to the child directly from the drinking glass.
Danish: Når tabletterne er helt opløst, bør hele opløsningen med det samme administreres til barnet direkte fra drikkeglasset.
English: Most patients with perimetry-confirmed defects had not previously spontaneously noticed any symptoms, even in cases where a severe defect was observed in perimetry.
Danish: De fleste patienter med perimetri-bekræftede defekter har ikke tidligere spontant bemærket nogen symptomer, heller ikke i de tilfælde, hvor en svær defekt blev observeret ved perimetri.
English: Risk factors for the development of these reactions include higher than recommended starting dose, faster dose escalation at higher steps than recommended and renal failure.
Danish: Risikofaktorer for udvikling af disse reaktioner omfatter en højere dosis end den anbefalede startdosis, hurtigere dosiseskalering med højere dosistrin end anbefalet og nyresvigt.
English: The tablets are scored on one side and can be divided into equal doses.
Danish: Tabletterne har en delekærv på den ene side og kan deles i lige store doser.
English: Ask your child's doctor to show you how to give this medicine.
Danish: Bed lægen om at vise dig, hvordan du skal give dette lægemiddel.
English: Vigabatrin should be gradually withdrawn under close medical supervision.
Danish: Vigabatrin bør gradvist seponeres under nøje medicinsk overvågning.
English: Median treatment duration: 44.4 months, mean daily dose 1.48 g 2 Median treatment duration: 20.6 months, mean daily dose 1.39 g 3 Median treatment duration: 48.8 months, mean daily dose 2.10 g Median treatment duration: 23.0 months, mean daily dose 2.18 g
Danish: 1 Median behandlingsvarighed: 44,4 måneder, gennemsnitlig daglig dosis 1,48 g 2 Median behandlingsvarighed: 20,6 måneder, gennemsnitlig daglig dosis 1,39 g 3 Median behandlingsvarighed: 48,8 måneder, gennemsnitlig daglig dosis 2,10 g 4 Median behandlingsvarighed: 23,0 måneder, gennemsnitlig daglig dosis 2,18 g
English: Number of tablets (strength) Evening
Danish: Antal tabletter (styrke) Aften
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: In a few patients, the lesion resolved despite continued use.
Danish: Hos nogle få patienter fortog læsionen sig på trods af fortsat behandling.
English: If you forget to give your child a dose, give the dose as soon as you remember.
Danish: Hvis du har glemt at give dit barn en dosis, skal du give ham/hende den, så snart du kommer i tanker om det.
English: Special care should be taken with young patients cycling, climbing or performing any other hazardous activity.
Danish: Der bør udvises særlig forsigtighed ved behandling af unge patienter, der cykler, klatrer eller udfører andre farlige aktiviteter.
English: Vigabatrin should not be used concomitantly with other retinotoxic medicinal products.
Danish: Vigabatrin bør ikke anvendes samtidigt med andre retinotoksiske lægemidler.
English: Vigabatrin increases the concentration of GABA, the major inhibitory neurotransmitter in the brain.
Danish: Vigabatrin øger koncentrationen af GABA, der er den største inhibitoriske neurotransmitter i hjernen.
English: Investigation s weight increased
Danish: Undersøgels er vægtforøgelse
English: Kigabeq should not be used in combination with other medicines that may have side effects related to the eye.
Danish: Kigabeq må ikke anvendes i kombination med andre lægemidler, der kan have øjenrelaterede bivirkninger.
English: VFD may not be detected until it is severe and undetected moderate defects may affect child integrity.
Danish: En synsfeltsdefekt opdages måske ikke, før den er svær, og uopdagede moderate defekter kan påvirke barnets integritet.
English: If control of epilepsy is not clinically significantly improved after an adequate treatment course, vigabatrin treatment should be discontinued.
Danish: Hvis kontrollen med epilepsi ikke er klinisk signifikant forbedret efter et passende behandlingsforløb, bør vigabatrin-behandlingen seponeres.
English: In the study above, in post-marketing experience, and in published literature reports, these changes generally resolved with discontinuation of treatment.
Danish: Data fra det ovennævnte studie, erfaring efter markedsføring og publiceret litteratur viser, at disse forandringer generelt fortog sig, når behandlingen blev seponeret.
English: However, do not decrease the dose without first talking to your child's doctor.
Danish: Men du må ikke reducere dosen uden at tale med lægen først.
English: The doctor will adjust the dose during treatment as necessary.
Danish: Lægen vil om nødvendigt justere dosis under behandlingen.
English: In a retrospective epidemiologic study in infants with infantile spasms (N=205), the prevalence of these changes was 22% in vigabatrin treated patients versus 4% in patients treated with other therapies.
Danish: I et retrospektivt epidemiologisk studie hos børn med infantile spasmer (N = 205) var forekomsten af disse forandringer 22 % hos vigabatrin-behandlede patienter sammenholdt med 4 % hos patienter, der blev behandlet med andre lægemidler.
English: • The mixture will be whitish and cloudy.
Danish: • Blandingen vil være hvidlig og grumset.
English: If you see unusual movements in your child, tell your child's doctor who may change the treatment.
Danish: Hvis du bemærker usædvanlige bevægelser hos dit barn, skal du sige det til lægen, der så kan ændre behandlingen.
English: Do not stop suddenly as this may cause your child's seizures to occur again.
Danish: Du må ikke pludselig holde op med at give medicinen, da det kan få dit barns anfald til at komme igen.
English: Pharmacokinetic properties of vigabatrin have been investigated in groups of six neonates (age 1526 days), six infants (age 5-22 months) and six children (age 4.6-14.2 years) with refractory epilepsy.
Danish: Vigabatrins farmakokinetiske egenskaber er undersøgt i grupper med seks nyfødte (i alderen 1526 dage), seks spædbørn (i alderen 5-22 måneder) og seks børn (i alderen 4,6-14,2 år) med refraktær epilepsi.
English: As vigabatrin is neither metabolised, nor protein bound and is not an inducer of hepatic cytochrome P450 metabolising-enzymes, interactions with other medicinal products are unlikely.
Danish: Da vigabatrin hverken metaboliseres eller bindes til proteiner og ikke er en inducer af cytokrom P450metaboliserende leverenzymer, er interaktioner med andre lægemidler ikke sandsynlige.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.
Danish: Selvmordstanker og selvmordsadfærd er rapporteret hos patienter i behandling med antiepileptiske lægemidler i flere indikationer.
English: Mean terminal half-life of vigabatrin was about 7.5 hours in neonates, 5.7 hours in infants and 5.5 hours in children.
Danish: Den gennemsnitlige halveringstid af vigabatrin var ca. 7,5 timer hos nyfødte, 5,7 timer hos spædbørn og 5,5 timer hos børn.
English: Frequency and severity have only been indirectly characterised in this population on the presence of electroretinogram or visual evoked potential anomalies.
Danish: Hyppighed og sværhedsgrad er kun indirekte karakteriseret i denne population ved tilstedeværelse af elektroretinogram- eller VEP-anomalier (Visual Evoked Potential).
English: White oval tablets.
Danish: Opløselig tablet Hvide ovale tabletter.
English: to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Gastric administration should be used for children who cannot swallow, but can be fed by enteral route.
Danish: Gastrisk administration bør anvendes hos børn, der ikke kan synke, men som kan fodres via sonde.
English: For instructions on dissolution and handling of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om fortynding og håndtering af lægemidlet før administration, se pkt.
English: The doctor works out the dose individually for your child, taking account of the child's body weight.
Danish: Lægen beregner dosen til dit barn specifikt ud fra barnets legemsvægt.
English: The benefit/risk ratio of vigabatrin should be evaluated on an individual patient basis.
Danish: Vigabatrins benefit/risk-forhold bør evalueres individuelt for hver enkelt patient.
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Danish: En metaanalyse af randomiserede placebokontrollerede studier af antiepileptiske lægemidler har også vist en lille øget risiko for selvmordstanker og selvmordsadfærd.
English: Vigabatrin is widely distributed with an apparent volume of distribution slightly greater than total body water.
Danish: Vigabatrin fordeles bredt med et tilsyneladende fordelingsvolumen, der er lidt større end de samlede kropsvæsker.
English: Because both tablet strengths (100 mg and 500 mg) can be used concomitantly there may be confusion between the tablets or tablet halves administered with a risk of incorrect dosing.
Danish: Da begge tabletstyrker (100 mg og 500 mg) kan anvendes samtidigt, kan der opstå forvirring omkring de administrerede tabletter eller halverede tabletter med risiko for ukorrekt dosering.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Danish: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100),
English: 15 to 30 kg:
Danish: 15-30 kg:
English: The plasma concentrations of carbamazepine, phenobarbital, and sodium valproate have also been monitored during controlled clinical trials and no clinically significant interactions have been detected.
Danish: Plasmakoncentrationen af carbamazepin, phenobarbital og natriumvalproat er også blevet overvåget i kontrollerede kliniske studier, og der er ikke konstateret nogen klinisk signifikante interaktioner.
English: Electroretinography is recommended in infants and children who are unable to cooperate with perimetry.
Danish: Elektroretinografi anbefales hos spædbørn og børn, som ikke er i stand til at samarbejde om perimetri.
English: If there is a risk of regurgitation or if the child is not old enough to drink from a glass, the whole content of solution should be withdrawn with a syringe for oral use, the end of the syringe should be put in the mouth of the child and gently pushed on the plunger.
Danish: Hvis der er risiko for gylpen, eller hvis barnet ikke er gammel nok til at drikke af et glas, bør hele opløsningen trækkes op med en sprøjte til oral anvendelse, sprøjtens ende placeres i munden på barnet og stemplet skubbes forsigtigt i bund.
English: Available data suggests that visual field defects are irreversible.
Danish: Tilgængelige data tyder på, at synsfeltsdefekter er irreversible.
English: • Give the mixture straightway to your child direct from the drinking glass or beaker
Danish: • Giv blandingen til dit barn med det samme direkte fra glasset eller målebægeret
English: As routine MRI surveillance of this paediatric population is not recommended, the frequency of MRI abnormalities cannot be reliably estimated from the available data.
Danish: Da rutinemæssig MR-scanning af den pædiatriske population ikke anbefales, kan hyppigheden af anomalierne på MR-billeder ikke estimeres på pålidelig vis ud fra de tilgængelige data.
English: If your child accidentally takes too many Kigabeq tablets, tell the doctor immediately or go to your nearest hospital or poison information centre.
Danish: Hvis dit barn utilsigtet har fået for mange Kigabeq-tabletter, skal du straks sige det til lægen eller tage hen på det nærmeste hospital eller giftinformationscenter.
English: Oral clearance (Cl/F) of vigabatrin is approximately 7 l/h (i.e. 0.10 l/h/kg).
Danish: Den orale clearance (Cl/F) af vigabatrin er ca. 7 l/t (dvs. 0,1 l/t/kg).
English: Possible signs of overdose include drowsiness or reduced level of consciousness.
Danish: Tegn på overdosering kan omfatte døsighed eller nedsat bevidsthedsniveau.
English: 10 to 15 kg:
Danish: 10-15 kg:
English: • Add the right dose of Kigabeq tablets (as whole or half tablets) to the water
Danish: • Tilsæt den ønskede dosis Kigabeq-tabletter (som hele eller halve tabletter) i vandet
English: Tell your child's doctor if your child has had or is going to perform laboratory tests because this medicine may lead to abnormal results.
Danish: Sig det til lægen, hvis dit barn har fået taget eller skal have taget laboratorieprøver, da dette lægemiddel kan medføre unormale prøveresultater.
English: Look for symptoms suggestive of such thoughts: disturbed sleep, loss of appetite or weight, isolation, loss of interest for favorite activities.
Danish: Se efter symptomer på sådanne tanker: forstyrret søvn, appetitløshed eller vægttab, isolation, tab af interesse for yndlingsbeskæftigelser.
English: The duration of the effect of the medicinal product is dependent on the GABA transaminase re-synthesis rate.
Danish: Varigheden af lægemidlets virkning afhænger af hastigheden af resyntesen af GABA-transaminase.
English: Blood and lymphatic system disorders anaemia
Danish: Blod og lymfesystem anæmi
English: All patients should have ophthalmological consultation before or shortly after the initiation of vigabatrin treatment.
Danish: Alle patienter bør få en oftalmologisk konsultation før eller kort tid efter påbegyndelse af behandling med vigabatrin.
English: Vigabatrin is not metabolised by hepatic enzymes, hence there is no need of adjustment of dose or frequency of administration.
Danish: Vigabatrin metaboliseres ikke af leverenzymer, og det er derfor ikke nødvendigt at tilpasse dosis eller hyppigheden af administration.
English: Number of tablets (strength) Morning
Danish: Antal tabletter (styrke) Morgen
English: Worsening of visual field loss may continue after stopping treatment.
Danish: Tabet af synsfelt kan fortsætte med at forværres efter ophør med behandlingen.
English: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne France
Danish: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne Frankrig
English: Vigabatrin-associated retinotoxicity has been observed in 80-100% of albino rats at the dose of 300 mg/kg/day orally, but not in pigmented rats, dogs or monkeys.
Danish: Vigabatrin-associeret nethindetoksicitet er observeret hos 80-100 % af albinorotter ved en oral dosis på 300 mg/kg/dag, men ikke hos pigmenterede rotter, hunde eller aber.
English: Patients (and caregivers of patients) should be advised to seek medical advice immediately should signs of suicidal ideation or behaviour emerge.
Danish: Patienter (og omsorgspersoner) bør tilrådes at søge lægehjælp øjeblikkeligt ved tegn på selvmordstanker eller selvmordsadfærd.
English: Epidemiology of VFD in patients with refractory partial epilepsy was observed in an observational, open-label, multicentre, comparative, parallel group, Phase IV study, including 734 patients, at least 8 years old, with refractory partial epilepsy for at least one year.
Danish: Epidemiologien for synsfeltsdefekter hos patienter med refraktær partiel epilepsi blev observeret i et observationelt, åbent, komparativt parallelgruppe-studie i fase 3 på flere centre med deltagelse af 734 patienter i alderen 8 år og opefter, som havde haft refraktær partiel epilepsi i mindst et år.
English: The retinal changes in albino rats were characterised as focal or multifocal disorganisation of the outer nuclear layer while the other layers of retina were not affected.
Danish: Retinaforandringerne hos albinorotter blev beskrevet som fokal eller multifokal desorganisering af det ydre kernelag, mens de øvrige lag i retina ikke var berørt.