FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare side effects (may affect up to 1 in 1,000 people) serious allergic reaction, which causes swelling of the face or throat.
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter) alvorlig allergisk reaktion, der giver hævelse i ansigt og svælg.
English: When provided, doses were most commonly between 7.5 to 30 g; however, ingestions up to 90 g have been reported.
Danish: I de tilfælde, hvor dosen er oplyst, var det hyppigst 7,5-30 g; der er imidlertid rapporteret om indtagelse af op til 90 g. I næsten halvdelen af tilfældene var der tale om indtagelse af flere forskellige lægemidler.
English: Kigabeq is to be given by mouth and may be taken before or after meals.
Danish: Kigabeq skal gives gennem munden og kan gives før eller efter et måltid.
English: Group I 1
Danish: Gruppe I1
English: Fill a drinking glass with one or two teaspoons of water (approximately 5 or 10 ml), according to the age of the child. Add the prescribed number of Kigabeq tablets or tablet halves to the water.
Danish: Fyld et glas med 1-2 teskefulde vand (ca. 5-10 ml) alt efter barnets alder. Kom det ordinerede antal hele eller halve Kigabeq-tabletter i vandet.
English: The solution should be administered immediately after preparation.
Danish: Opløsningen skal indgives umiddelbart efter klargøring.
English: Psychiatric reactions have been reported during vigabatrin therapy.
Danish: Psykiske reaktioner er rapporteret under behandlingen med vigabatrin.
English: Pooled data from prevalence surveys suggest that as many as 1/3 of patients receiving vigabatrin therapy have VFDs.
Danish: Puljede data fra prævalensundersøgelser peger på, at op til 1/3 af de patienter, der får vigabatrinbehandling, har synsfeltsdefekter.
English: Contact the doctor if your child has these effects suicide attempt other eye problems such as retinal disorder, causing, for example, poor vision at night and difficulty adjusting from bright to dim areas, sudden or unexplained loss of vision, sensitivity to light
Danish: Kontakt lægen, hvis dit barn får disse bivirkninger selvmordsforsøg andre øjenproblemer, herunder nethindelidelser, der f.eks. kan give dårligt nattesyn og problemer med at omstille sig fra lyse til mørke områder, pludseligt eller uventet synstab, lysfølsomhed
English: The solution in water is whitish and cloudy.
Danish: Opløsningen i vand er hvidlig og grumset.
English: Psychiatric events (e.g., agitation, depression, abnormal thinking, paranoid reactions) have been reported during vigabatrin treatment.
Danish: Psykiske bivirkninger (f.eks. uro, depression, unormal tankevirksomhed, paranoide reaktioner) er rapporteret under behandling med vigabatrin.
English: Visual field loss (loss of sight from the edges of your child's field of vision) may occur during treatment with vigabatrin.
Danish: Tab af synsfelt (indskrænkning af synsfeltet) kan opstå under behandling med vigabatrin.
English: The tube should be rinsed with 10 ml of water
Danish: Sonden bør skylles med 10 ml vand
English: This visual field defect can range from mild to severe.
Danish: Disse synsfeltsdefekter kan være milde til svære.
English: The adverse reactions listed below have been reported during pre- or post-approval use of vigabatrin worldwide.
Danish: De nedenfor anførte bivirkninger er indberettet før og efter godkendelse af vigabatrin verden over.
English: In the brain, microvacuolation due to intramyelinic oedema has been observed in white matter tracts of rat, mouse and dog at doses of 30-50 mg/kg/day.
Danish: Der er observeret mikrovakuolation som følge af intramyelint ødem i den hvide substans i hjernen hos rotter, mus og hunde ved doser på 30-50 mg/kg/dag.
English: Movement disorders either alone or in association with abnormalities in MRI have been reported in patients treated with vigabatrin for infantile spasms but their frequency is not known.
Danish: Bevægeforstyrrelser enten alene eller i forbindelse med anomalier på MR-billeder er rapporteret hos patienter i behandling med vigabatrin mod infantile spasmer, men hyppigheden kendes ikke.
English: Contact the doctor if your child has these psychological effects nausea (feeling sick), vomiting and abdominal pain blurred vision, double vision and uncontrolled movement of the eye, which may cause dizziness speech disorder decrease in the number of red blood cells (anaemia)
Danish: Kontakt lægen, hvis dit barn får disse psykiske bivirkninger kvalme, opkastning og mavesmerter sløret syn, dobbeltsyn og ukontrollerede øjenbevægelser, der kan give svimmelhed taleforstyrrelser nedsat antal røde blodlegemer (blodmangel)
English: Other less frequently reported symptoms included vertigo, headache, psychosis, respiratory depression or apnoea, bradycardia, hypotension, agitation, irritability, confusion, abnormal behaviour, and speech disorder.
Danish: Andre mindre hyppige symptomer omfatter vertigo, hovedpine, psykose, respirationsdepression eller apnø, bradykardi, hypotension, uro, irritabilitet, konfusion, unormal adfærd og taleforstyrrelser.
English: The effectiveness of haemodialysis in the treatment of vigabatrin overdose is unknown.
Danish: Virkningen af hæmodialyse til behandling af en overdosis vigabatrin kendes ikke.
English: The assessment must be continued 6 to 12 months after the discontinuation of therapy (see Visual Field Defects).
Danish: Undersøgelsen bør fortsættes 612 måneder efter behandlingsophør (se Synsfeltsdefekter).
English: Undesirable effects ranked under headings of frequency are listed below, using the following convention:
Danish: Hyppigheden af bivirkninger er anført i henhold til følgende konvention:
English: If your child has visual disturbances, contact your child's doctor or hospital immediately.
Danish: Hvis dit barn har synsforstyrrelser, skal du kontakte lægen eller hospitalet med det samme.
English: Group III Group I 3
Danish: Gruppe II2 Gruppe III Gruppe I3
English: Psychiatric disorders agitation, aggression, nervousness, depression, paranoid reaction hypomania, mania, psychotic disorder suicide attempt hallucination
Danish: Psykiske forstyrrelser uro, aggressiv adfærd, nervøsitet, depression, paranoid reaktion hypomani, mani, psykotisk forstyrrelse selvmord sforsøg hallucinationer
English: If your child takes too much Kigabeq
Danish: Hvis dit barn har fået for meget Kigabeq
English: A deterioration of VFD after the treatment is discontinued cannot be excluded.
Danish: En forværring af synsfeltsdefekter efter seponering af behandlingen kan ikke udelukkes.
English: Since vigabatrin is eliminated via the kidneys, caution should be exercised when administering the medicinal product to patients with creatinine clearance less than 60 ml/min.
Danish: Da vigabatrin elimineres via nyrerne, bør der udvises forsigtighed ved administration af lægemidlet hos patienter med en kreatinin-clearance under 60 ml/min.
English: Proposed doses for first titration step (75 mg/kg/day) (Day 3)
Danish: Foreslåede doser til første titreringstrin (75 mg/kg/dag) (dag 3)
English: One soluble tablet of Kigabeq 100 mg contains 100 mg vigabatrin One soluble tablet of Kigabeq 500 mg contains 500 mg vigabatrin - The other ingredients are: crospovidone type B, mannitol, sodium stearyl fumarate
Danish: - Aktivt stof: vigabatrin - Én opløselig tablet Kigabeq 100 mg indeholder 100 mg vigabatrin - Én opløselig tablet Kigabeq 500 mg indeholder 500 mg vigabatrin - Øvrige indholdsstoffer: crospovidon type B, mannitol, natriumstearylfumarat
English: Visual field defects (VFD) have been reported in patients receiving vigabatrin with a high prevalence (about 1/3 of patients).
Danish: Der er rapporteret om høj forekomst af synsfeltsdefekter hos patienter, der fik vigabatrin (ca. 1/3 af patienterne).
English: Abnormal Magnetic Resonance Imaging (MRI) signal changes characterised by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants treated with vigabatrin for infantile spasms.
Danish: Abnorme signalforandringer på MR-billeder karakteriseret ved øget T2-signal og begrænset diffusion i et symmetrisk mønster, der omfatter thalamus, basalganglier, hjernestamme og cerebellum, er observeret hos nogle spædbørn, der har fået vigabatrin mod infantile spasmer.
English: • Pour one or two teaspoonfuls (about 5 to 10 ml) of water into a drinking glass or beaker
Danish: • Kom 1-2 teskefulde vand (ca. 5-10 ml) i et glas eller et målebæger
English: Do not give Kigabeq: if your child is allergic to vigabatrin or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis dit barn er allergisk over for vigabatrin eller et af de øvrige indholdsstoffer i Kigabeq (angivet i punkt 6).
English: Since vigabatrin is eliminated via the kidneys, caution should be exercised in patients with a creatinine clearance of less than 60 ml/min.
Danish: Da vigabatrin elimineres via nyrerne, bør der udvises forsigtighed hos patienter med en kreatininclearance under 60 ml/min.
English: Some patients may have more seizures (fits) whilst taking Kigabeq.
Danish: Nogle patienter kan få flere anfald, mens de er i behandling med Kigabeq.
English: Very rare side effects (may affect up to 1 in 10,000 people) other eye problems such as pain in eyes (optic neuritis) and loss of vision, including colour vision (optic atrophy) hallucinations (feeling, seeing or hearing things that are not there) liver problems
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 patienter) andre øjenproblemer som f.eks. øjensmerter (optisk neuritis) og synstab, herunder tab af farvesynet (optisk atrofi) hallucinationer (hvor man føler, ser eller hører ting, der ikke er der) leverproblemer
English: Other medicines and Kigabeq
Danish: Brug af anden medicin sammen med Kigabeq
English: You should discuss this possibility with the doctor before your child begins treatment and the doctor will tell you how to detect this side effect.
Danish: Du bør tale med lægen om denne mulige bivirkning, før dit barn begynder på behandlingen.
English: The method of administration will be determined by a physician specialised in epileptology, neurology or paediatric neurology.
Danish: Administrationsmetoden afgøres af en læge, der er specialiseret i epileptologi, neurologi eller pædiatrisk neurologi.
English: Kigabeq is for oral or gastric use and may be taken before or after meals.
Danish: Kigabeq er til oral eller gastrisk anvendelse og kan tages før eller efter et måltid.
English: Vigabatrin is a water soluble compound and it is rapidly and completely absorbed from the gastrointestinal tract.
Danish: Vigabatrin er et vandopløseligt stof, der absorberes hurtigt og fuldstændigt fra mave-tarm-kanalen.
English: Tell your child's doctor if the child is taking, has recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis dit barn bruger anden medicin eller har gjort det for nylig.
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Danish: Hvis dit barn oplever bivirkninger, bør du tale med lægen eller apoteket.
English: For patients who cannot swallow, administration of Kigabeq using a gastric tube is possible.
Danish: Patienter, der ikke kan synke, kan få Kigabeq administreret via en gastrisk sonde.
English: Common Uncommon Rare Very rare Not known
Danish: Sjælden Meget sjælden
English: These events occurred in patients with and without a psychiatric history and were usually reversible when vigabatrin doses were reduced or gradually discontinued.
Danish: Disse tilfælde forekom hos patienter med og uden tidligere psykiske lidelser og var typisk reversible, når vigabatrin-doserne blev reduceret eller behandlingen gradvist seponeret.
English: Such reactions have been fully reversible following dose reduction or discontinuation of vigabatrin (see section 4.4).
Danish: Disse reaktioner har været fuldt reversible efter dosisreduktion eller seponering af vigabatrin (se pkt.
English: Activated charcoal has been shown to not significantly adsorb vigabatrin in an in vitro study.
Danish: Det er i et in vitro-studie påvist, at aktivt kul ikke i signifikant grad adsorberer vigabatrin.
English: Eye disorders visual field defect vision blurred, diplopia, nystagmus retinal disorder (such as peripheral retinal atrophy)
Danish: Øjne synsfeltsde fekter sløret syn, diplopi, nystagmus nethindeli delser (som f.eks. perifer nethindea trofi)
English: Abnormal Magnetic Resonance Imaging signals
Danish: Abnorme signaler på MR-billeder
English: Nervous system disorders somnolenc e speech disorder, headache, dizziness, paraesthesia, disturbance in attention and memory impairment, mental impairment (thought disturbance), tremor coordination abnormal (ataxia)
Danish: Nervesystem et somnolens taleforstyrrelse r, hovedpine, svimmelhed, paræstesi, opmærksomhe dsforstyrrelser og hukommelsest ab, mental svækkelse (forstyrrelse af tankevirksomh eden), tremor unormal koordinationse vne (ataksi)
English: Common side effects (may affect up to 1 in 10 people) headache weight gain shaking (tremor ) swelling (oedema) dizziness sensation of numbness or tingling (pins and needles) reduced concentration and memory psychological problems including agitation, aggression, nervousness, irritability, depression, thought disturbance and feeling suspicious without reason (paranoia).
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter) hovedpine vægtøgning rysten hævelser svimmelhed følelsesløshed, prikkende/stikkende fornemmelse nedsat koncentration og hukommelse psykiske problemer, herunder uro, aggressivitet, nervøsitet, irritabilitet, depression, tankeforstyrrelser og mistænksomhed uden grund (paranoia).
English: The gastric tube should be rinsed with 10 ml of water.
Danish: Den gastriske sonde bør skylles med 10 ml vand.
English: Very common side effects (may affect more than 1 in 10 people) excitation or restlessness tiredness and pronounced sleepiness joint pain
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter) ophidselse eller rastløshed træthed og udtalt søvnighed ledsmerter
English: Follow-up should be arranged under supervision of a specialist in epileptology, neurology or paediatric neurology.
Danish: Der bør planlægges opfølgning under overvågning af en speciallæge i epileptologi, neurologi eller pædiatrisk neurologi.
English: In view of the results of the animal safety studies (see section 5.3) it is recommended that patients treated with vigabatrin are closely observed for adverse reactions on neurological function.
Danish: 5.3) anbefales det, at patienter, der behandles med vigabatrin, monitoreres tæt for bivirkninger relateret til den neurologiske funktion.
English: Very common side effects (may affect more than 1 in 10 people) Visual field changes - About 33 out of 100 patients treated with vigabatrin may have changes in the visual field (narrow visual field).
Danish: Søg læge med det samme, hvis dit barn får følgende bivirkninger: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter) - Ændret synsfelt - ca. 33 ud af 100 patienter, der behandles med vigabatrin, kan opleve ændringer i synsfeltet (indsnævring af synsfeltet).
English: Some patients may experience an increase in seizure frequency or the onset of new types of seizures with vigabatrin (see section 4.8).
Danish: Nogle patienter kan opleve en stigning i hyppigheden af krampeanfald eller debut af nye typer krampeanfald ved behandling med vigabatrin (se pkt.
English: The most commonly reported adverse reaction related to vigabatrin are visual field defects (ranging from mild to severe and occurring usually after months to years of vigabatrin therapy), psychiatric disorders such as agitation, excitation, aggression, nervousness, depression, paranoid reaction, nervous system disorders such as marked sedation, stupor and confusion.
Danish: De hyppigst indberettede bivirkninger relateret til vigabatrin er synsfeltsdefekter (der er lette til svære, og som typisk opstår måneder til år efter påbegyndelse af vigabatrin-behandlingen), psykiske forstyrrelser som f.eks. uro, ophidselse, aggressiv adfærd, nervøsitet, depression, paranoid reaktion, påvirkning af nervesystemet som f.eks. udtalt sedation, stupor og konfusion.
English: This medicinal product is not intended for use in women who are breastfeeding.
Danish: Dette lægemiddel er ikke beregnet til anvendelse hos kvinder, der ammer.
English: If your child has these symptoms, you should tell his/her doctor immediately hives or nettle rash marked sedation (sleepiness), stupor and confusion (encephalopathy).
Danish: Hvis dit barn har disse symptomer, skal du sige det lægen med det samme nældefeber markant søvnighed, sløvhed og forvirring (encefalopati).
English: If you forget to give your child Kigabeq
Danish: Hvis du har glemt at give dit barn Kigabeq
English: Vigabatrin treatment may only be initiated by a specialist in epileptology, neurology or paediatric neurology.
Danish: Behandling med vigabatrin må kun iværksættes af en speciallæge i epileptologi, neurologi eller pædiatrisk neurologi.
English: Starting dose of 40 mg/kg/day
Danish: Startdosis på 40 mg/kg/dag
English: These reactions occurred in patients with and without a psychiatric history and were usually reversible when vigabatrin doses were reduced or gradually discontinued (see section 4.4).
Danish: Disse reaktioner forekom hos patienter med og uden tidligere psykiske lidelser og var typisk reversible, når vigabatrin-doserne blev reduceret eller behandlingen gradvist seponeret (se pkt.
English: Uncommon side effects (may affect up to 1 in 100 people) lack of coordination or fumbling more severe psychological problems such as feeling elated or over-excited, which causes unusual behaviour, and feeling detached from reality skin rash
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter) manglende koordination eller klodsethed alvorlige psykiske problemer som f.eks. opstemthed (mani), der kan medføre usædvanlig adfærd, følelse af manglende kontakt til virkeligheden hududslæt
English: Asymptomatic and transient Magnetic Resonance Imaging (MRI) abnormalities in the brain have been observed in some infants treated with vigabatrin for infantile spasms.
Danish: Asymptomatiske og forbigående anomalier på MR-billeder af hjernen er observeret hos nogle spædbørn, der fik vigabatrin mod infantile spasmer.
English: Table 1: Number of soluble tablets according to body weight, starting dose and dose increment in infantile spasms Body we ight (kg)
Danish: Tabel 1: Antal opløselige tabletter i henhold til legemsvægt, startdosis og dosistrin ved infantile spasmer
English: Patients should be evaluated for the presence of visual field defects (see also section 4.4).
Danish: Patienterne bør undersøges for synsfeltsdefekter (se også pkt.
English: Abrupt withdrawal may lead to rebound seizures.
Danish: Pludselig seponering kan medføre rebound-krampeanfald.
English: What you need to know before your child takes Kigabeq 3.
Danish: Det skal du vide, før du giver dit barn Kigabeq 3.
English: Fertility studies in rats have shown no effect on male and female fertility (see section 5.3).
Danish: Fertilitetsstudier hos han- og hunrotter har ikke påvist nogen effekt på reproduktionsevnen (se pkt.
English: Starting dose of 50 mg/kg/day
Danish: Startdosis på 50 mg/kg/dag
English: In resistant partial epilepsy (focal onset seizures), the recommended starting dose is 40 milligrams per kilogram daily.
Danish: Ved resistent partiel epilepsi (fokale anfald) er den anbefalede startdosis 40 mg pr. kg dagligt.
English: Visual field defects
Danish: Synsfeltsdefekter
English: If you have any further questions, ask your child's doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: After administration of a single 37-50 mg/kg dose of an oral solution vigabatrin tmax was approximately 2.5 hours in neonates and infants, and 1 hour in children.
Danish: Efter administration af en enkeltdosis vigabatrin på 37-50 mg/kg som oral opløsning var tmax ca.
English: The onset is usually after months to years of vigabatrin therapy.
Danish: Debut er typisk flere måneder til år efter påbegyndelse af vigabatrin-behandlingen.
English: These events have been reversible following dose reduction or discontinuation of vigabatrin (see section 4.8).
Danish: Disse tilfælde har været reversible efter dosisreduktion eller seponering af vigabatrin (se pkt.
English: Pack size: 50 soluble tablets.
Danish: Pakningsstørrelse: 50 opløselige tabletter.
English: Patients should be monitored for adverse reactions such as sedation or confusion (see sections 4.4 and 4.8).
Danish: Patienterne bør overvåges for bivirkninger som f.eks. sedation eller konfusion (se pkt.
English: 100 mg tablet size: 9.4 mm x 5.3 mm 500 mg tablet size: 16.0 mm x 9.0 mm
Danish: 100 mg-tablettens størrelse: 9,4 mm x 5,3 mm 500 mg-tablettens størrelse: 16,0 mm x 9,0 mm
English: If you stop giving Kigabeq to your child
Danish: Hvis du holder op med at give dit barn Kigabeq
English: However, the VFDs reported in patients receiving vigabatrin have ranged from mild to severe.
Danish: De indberettede synsfeltsdefekter hos patienter, der får vigabatrin, har været lette til svære.
English: In infantile spasms (West's Syndrome), the recommended starting dose is 50 milligrams per kilogram bodyweight daily.
Danish: Ved infantile spasmer (Wests syndrom) er den anbefalede startdosis 50 mg pr. kg legemsvægt dagligt.
English: Pack size: 100 soluble tablets.
Danish: Pakningsstørrelse: 100 opløselige tabletter.
English: Hepatobiliar y disorders hepatitis
Danish: Lever og galdeveje hepatitis
English: Each soluble tablet contains 100 mg vigabatrin.
Danish: Hver opløselig tablet indeholder 100 mg vigabatrin.
English: Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.
Danish: Kigabeq er indiceret til spædbørn og børn i alderen 1 måned til under 7 år til: enkeltstofbehandling af infantile spasmer (Wests syndrom) behandling i kombination med andre antiepileptika hos patienter med resistent partiel epilepsi (fokale anfald) med eller uden sekundær generalisering, når alle andre relevante lægemiddelkombinationer har vist sig utilstrækkelige eller ikke tolereres.
English: • If your child cannot drink from the glass or beaker then you can use an oral syringe to gently squirt the mixture into your child's mouth, taking care not to cause choking: sit just in front and below your child in order that he/she has the head leaning forward and administer the mixture against his cheek
Danish: For at han/hun ikke skal få blandingen galt i halsen, skal du sidde lige foran og lidt lavere nede end barnet, så han/hun læner hovedet lidt fremover, og sprøjte blandingen ind mod hans/hendes kind
English: The resulting solution is whitish and cloudy.
Danish: Opløsningen bliver herefter hvidlig og grumset.
English: Each soluble tablet contains 500 mg vigabatrin.
Danish: Hver opløselig tablet indeholder 500 mg vigabatrin.
English: Very common: excitation, agitation
Danish: Psykiske forstyrrelser Meget almindelige bivirkninger: ophidselse, uro.
English: Use immediately following preparation of the oral solution.
Danish: Den orale opløsning bør anvendes straks efter klargøring.
English: In isolated case reports in renal failure patients receiving therapeutic doses of vigabatrin, haemodialysis reduced vigabatrin plasma concentrations by 40% to
Danish: I enkeltstående tilfælde har hæmodialyse reduceret plasmakoncentrationen af vigabatrin med 40-60 % hos patienter med nyresvigt, der fik terapeutiske doser af vigabatrin.
English: This medicinal product is not intended for use in women of child-bearing potential.
Danish: Dette lægemiddel er ikke beregnet til anvendelse hos kvinder, der kan blive gravide.
English: General disorders and fatigue oedema, irritability administratio n site conditions
Danish: Almene symptomer og reaktioner på administratio nsstedet træthed ødem, irritation