FrancophonIA/ELRC3.0 huggingface dataset:
English: No effects on the Cmax or AUC of cannabidiol were observed following administration of a single dose of cannabidiol 200 mg in subjects with mild, moderate, or severe renal impairment when compared to patients with normal renal function.
Danish: Der blev ikke observeret nogen virkninger på cannabidiols Cmax eller AUC efter administration af en enkelt dosis af cannabidiol 200 mg til forsøgspersoner med let, moderat eller svært nedsat nyrefunktion sammenlignet med patienter med normal nyrefunktion.
English: If the dose is more than 5 ml, repeat Steps 4 to 7 to give the remaining dose using the 5 ml oral syringe.
Danish: Hvis din dosis er på over 5 ml, skal du gentage trin 4 til 7 for at få resten af dosen med 5 ml-sprøjten.
English: As with other AEDs, a clinically relevant increase in seizure frequency may occur during treatment with cannabidiol, which may require adjustment in dose of cannabidiol and/or concomitant AEDs, or discontinuation of cannabidiol, should the benefit-risk be negative.
Danish: Som med andre antiepileptika kan der forekomme en klinisk relevant stigning i hyppigheden af krampeanfald under behandling med cannabidiol, som kan nødvendiggøre justering af cannabidiol-dosis og/eller samtidige antiepileptika eller seponering af cannabidiol, hvis benefit/risk-forholdet er negativt.
English: The primary endpoint was the change in convulsive seizure frequency during the treatment period (Day 1 to the end of the evaluable period) compared to baseline (GWPCARE2), and the percentage change from baseline in convulsive seizures per 28 days over the treatment period (GWPCARE1) for the cannabidiol groups compared to placebo.
Danish: Det primære endepunkt var ændringen i hyppigheden af krampeanfald i behandlingsperioden (dag 1 til afslutningen af den evaluerbare periode) sammenlignet med baseline (GWPCARE2) og den procentvise ændring i krampeanfald i forhold til baseline i løbet af 28 dage i behandlingsperioden (GWPCARE1) i cannabidiol-grupperne sammenlignet med placebo.
English: Hepatocellular injury
Danish: Hepatocellulær skade
English: A lower starting dose is recommended in patients with moderate or severe hepatic impairment.
Danish: Det anbefales at anvende en lavere startdosis hos patienter med moderat eller svært nedsat leverfunktion.
English: CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT1A9, and UGT2B7 Substrates In vitro data predict drug-drug interactions with CYP1A2 substrates (e.g., theophylline, caffeine), CYP2B6 substrates (e.g., bupropion, efavirenz), uridine 5' diphospho-glucuronosyltransferase 1A9 (UGT1A9) (e.g., diflunisal, propofol, fenofibrate), and UGT2B7 (e.g., gemfibrozil, morphine, lorazepam) when co-administered with cannabidiol.
Danish: CYP1A2-, CYP2B6-, CYP2C8-, CYP2C9-, CYP2C19-, UGT1A9- og UGT2B7-substrater Som følges af in vitro-data forventes der lægemiddelinteraktioner med CYP1A2-substrater (f.eks. teofyllin, koffein), CYP2B6-substrater (f.eks. bupropion, efavirenz), uridin 5' difosfo-glucuronosyltransferase 1A9 (UGT1A9) (f.eks. diflunisal, propofol, fenofibrat) og UGT2B7 (f.eks. gemfibrozil, morfin, lorazepam) ved administration samtidigt med cannabidiol.
English: After multiple dosing with cannabidiol, the 7-OH-CBD metabolite (active in a preclinical model of seizure) circulates in human plasma at lower concentrations than the parent drug cannabidiol (~ 40% of CBD exposure) based on AUC.
Danish: Efter flere doser cannabidiol cirkulerer 7-OH-CBD-metabolitten (aktiv i en præklinisk model af anfald) i humant plasma ved lavere koncentrationer end moderstoffet cannabidiol (~ 40 % af CBD-eksponering) på baggrund af AUC.
English: In patients with LGS, population pharmacokinetic pharmacodynamic (PK/PD) modelling indicated the presence of an exposure efficacy relationship for the likelihood of achieving a ≥ 50% reduction in drop seizure frequency across the cannabidiol dose range tested (0 [placebo], 10 and 20 mg/kg/day).
Danish: Hos patienter med LGS tydede farmakokinetisk/farmakodynamisk (PK/PD) populationsmodellering på tilstedeværelsen af et eksponeringsvirkningsforhold vedrørende sandsynligheden for at opnå en ≥ 50 % reduktion i hyppigheden af anfald, som forårsager fald, på tværs af det testede cannabidiol-dosisinterval (0 [placebo], 10 og 20 mg/kg/dag).
English: Serum transaminases and total bilirubin levels should be obtained at 1 month, 3 months, and 6 months after initiation of treatment with cannabidiol, and periodically thereafter or as clinically indicated.
Danish: Niveauerne af serumtransaminaser og total bilirubin skal fastlægges 1 måned, 3 måneder og 6 måneder efter påbegyndelse af behandling med cannabidiol og med jævne mellemrum derefter som klinisk indiceret.
English: In controlled studies for LGS and DS, the incidence of ALT elevations above 3 times the ULN was 13% in cannabidiol-treated patients compared with 1% in patients on placebo.
Danish: I kontrollerede studier af LGS og DS var forekomsten af forhøjet ALAT over 3 gange ULN 13 % hos patienter, der fik behandling med cannabidiol, sammenlignet med 1 % hos patienter, der fik placebo.
English: Table 1: Dose adjustments in patients with moderate or severe hepatic impairment
Danish: Tabel 1: Dosisjustering hos patienter med moderat eller svært nedsat leverfunktion
English: Any dose increases above 10 mg/kg/day, up to the maximum recommended dose of 20 mg/kg/day, should be made considering individual benefit and risk and with adherence to the full monitoring schedule (see section 4.4).
Danish: Enhver dosisøgning på over 10 mg/kg/dag op til den maksimalt anbefalede dosis på 20 mg/kg/dag skal foretages under hensyntagen til fordele og risici for den enkelte patient og under overholdelse af det fulde monitoreringsskema (se pkt.
English: Based on individual clinical response and tolerability, each dose can be further increased in weekly increments of 2.5 mg/kg administered twice daily (5 mg/kg/day) up to a maximum recommended dose of 10 mg/kg twice daily (20 mg/kg/day).
Danish: På baggrund af den enkelte patients kliniske respons og tolerabilitet kan den enkelte dosis øges yderligere hver uge i form af en stigning på 2,5 mg/kg administreret to gange dagligt (5 mg/kg/dag) op til en maksimal anbefalet dosis på 10 mg/kg to gange dagligt (20 mg/kg/dag).
English: Patients with elevated baseline transaminase levels above 3 times the ULN, or elevations in bilirubin above 2 times the ULN, should be evaluated prior to initiation of cannabidiol treatment.
Danish: Patienter med forhøjede transaminaseniveauer ved baseline på over 3 gange ULN, eller forhøjet bilirubin over 2 gange ULN, skal evalueres inden påbegyndelse af behandling med cannabidiol.
English: The frequency in patients receiving 10 mg/kg/day cannabidiol and taking clobazam was 36%.
Danish: Hyppigheden for patienter, som fik 10 mg/kg/dag cannabidiol og tog clobazam, var 36 %.
English: No effect on clobazam levels.
Danish: Ingen virkning på clobazam-niveauer.
English: Cannabidiol should be discontinued in any patients with elevations of transaminase levels greater than 3 times the ULN and bilirubin levels greater than 2 times the ULN.
Danish: Cannabidiol skal seponeres hos alle patienter med forhøjede transaminaseniveauer over 3 gange ULN og forhøjede bilirubinniveauer over 2 gange ULN.
English: Cannabidiol is not a substrate for or an inhibitor of the brain uptake transporters OATP1A2 and OATP2B1.
Danish: Cannabidiol er ikke et substrat for eller en hæmmer af hjerneoptagstransportørerne OATP1A2 og OATP2B1.
English: If you or your patient take more Epidyolex than you should If you may have taken more Epidyolex than you should, tell a doctor or pharmacist immediately, or contact your nearest hospital casualty department, and take the medicine with you.
Danish: Hvis du eller patienten har taget for meget Epidyolex Hvis du har taget for meget Epidyolex, skal du straks fortælle det til lægen eller apotekspersonalet eller tage på den nærmeste skadestue.
English: In LGS and DS patients, the mean decrease in haemoglobin from baseline to end of treatment was −0.37 g/dL in cannabidiol-treated patients.
Danish: Hos patienter med LGS og DS, var det gennemsnitlige fald i hæmoglobin fra baseline til afslutning af behandlingen -0,37 g/dl hos patienter, der fik cannabidiol.
English: Interaction resulting in a decrease (approximately 30%) in Cmax and AUC of the active metabolite 7-OH-CBD in HV* trials.
Danish: Interaktion resulterende i et fald (ca. 30 %) i Cmax og AUC for den aktive metabolit 7-OH-CBD i forsøg med raske frivillige.
English: Patients with transaminase elevations greater than 3 times the upper limit of normal (ULN) and bilirubin greater than 2 times the ULN (see section 4.4).
Danish: Patienter med transaminaseforhøjelser på over 3 gange den øvre grænse for normal (ULN) og bilirubin på over 2 gange ULN (se pkt.
English: Interaction resulting in approximately 3-fold increase in N-desmethylclobazam metabolite exposure.
Danish: Interaktion resulterende i en stigning på ca. 3 gange i eksponering for Ndesmethylclobazam-metabolit.
English: After one week, the dose should be increased to a maintenance dose of 5 mg/kg twice daily (10 mg/kg/day).
Danish: Efter en uge skal dosen øges til en vedligeholdelsesdosis på 5 mg/kg to gange dagligt (10 mg/kg/dag).
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apotekspersonalet.
English: Weight decreased a Grouped Terms: Pneumonia: Pneumonia, Pneumonia RSV, Pneumonia mycoplasmal, Pneumonia adenoviral, Pneumonia viral, Aspiration pneumonia; Somnolence: Somnolence, Sedation.
Danish: Almindelig Vægttab a Grupperede termer: Pneumoni: Pneumoni, pneumoni forårsaget af RSV, pneumoni forårsaget af mycoplasma, pneumoni forårsaget af adenovirus, viral pneumoni, aspirationspneumoni; Døsighed: Døsighed, sedation.
English: - you stop taking Epidyolex suddenly.
Danish: - du pludselig holder op med at tage Epidyolex.
English: The most commonly used cAEDs (> 25% of patients) in both trials were valproate, clobazam, lamotrigine, levetiracetam, and rufinamide.
Danish: De mest almindeligt anvendte samtidige antiepileptika (> 25 % af patienterne) i begge forsøg var valproat, clobazam, lamotrigin, levetiracetam og rufinamid.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release GW Pharma (International) B.V., Databankweg 26
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse GW Pharma (International) B.V., Databankweg 26
English: Amber glass bottle (type III) with a child-resistant and tamper-evident screw cap (polypropylene).
Danish: Brun glasflaske (type III) med børnesikret og forseglet skruelåg (polypropylen).
English: The most common adverse reactions are somnolence, decreased appetite, diarrhoea, pyrexia, fatigue, and vomiting.
Danish: De mest almindelige bivirkninger er døsighed, nedsat appetit, diarré, pyreksi, træthed og opkastning.
English: Exposure to phenytoin may be increased when it is co-administered with cannabidiol, as phenytoin is largely metabolised via CYP2C9, which is inhibited by cannabidiol in vitro.
Danish: Der kan forekomme en stigning i eksponeringen for fenytoin ved administration samtidigt med cannabidiol, da fenytoin i vidt omfang metaboliseres via CYP2C9, som hæmmes af cannabidiol in vitro.
English: Lamotrigine
Danish: Lamotrigin
English: Hypersensitivity to the active substance, to sesame oil, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, over for sesamolie eller over for et eller flere af hjælpestofferne anført i pkt.
English: The frequency in patients receiving 20 mg/kg/day cannabidiol and taking clobazam was 41%.
Danish: Hyppigheden hos patienter, som fik 20 mg/kg/dag cannabidiol og tog clobazam, var 41 %.
English: Cannabidiol should be used with caution in patients with moderate or severe hepatic impairment.
Danish: Der bør udvises forsigtighed ved anvendelse af cannabidiol til patienter med moderat eller svært nedsat leverfunktion.
English: Taking Epidyolex with food can increase the amount of medicine your body takes in. You should try, as far as possible, to take Epidyolex consistently either with or without food, and according to your daily routine, so you get the same effect each time.
Danish: Du skal så vidt muligt forsøge at tage Epidyolex på samme måde enten med eller uden mad og i forbindelse med dine daglige rutiner, så du får den samme virkning hver gang.
English: Mean age of the study population was 15 years and 94% were taking 2 or more concomitant AEDs (cAEDs) during the trial.
Danish: Studiepopulationens gennemsnitsalder var 15 år, og 94 % tog 2 eller flere samtidige antiepileptika under forsøget.
English: Reduction in dose of clobazam should be considered if somnolence or sedation are experienced when clobazam is co-administered with cannabidiol.
Danish: Det skal overvejes at reducere dosen af clobazam, hvis der forekommer døsighed eller sedation ved samtidig administration af clobazam og cannabidiol.
English: Do not push the plunger forcefully or direct the medicine to the back of the mouth or throat.
Danish: Skub ikke for hårdt på stemplet, og ret ikke sprøjten mod bagenden af munden eller svælget.
English: The NOAEL was associated with maternal plasma cannabidiol exposures approximately 9 times that in humans at 20 mg/kg/day.
Danish: NOAEL var forbundet med maternelle plasmaeksponeringer for cannabidiol på ca. 9 gange den for mennesker ved 20 mg/kg/dag.
English: In vitro assessment of interaction with UGT enzymes In vitro data suggest that cannabidiol is a reversible inhibitor of UGT1A9 and UGT2B7-mediated activity at clinically relevant concentrations.
Danish: In vitro-vurdering af interaktion med UGT-enzymer In vitro-data tyder på, at cannabidiol er en reversibel hæmmer af UGT1A9- og UGT2B7-medieret aktivitet ved klinisk relevante koncentrationer.
English: The metabolite 7-COOH-CBD is a P-gp/MDR1 substrate and has the potential to inhibit BCRP, OATP1B3, and OAT3.
Danish: Metabolitten 7-COOH-CBD er et P-gp/MDR1-substrat og kan potentielt hæmme BCRP, OATP1B3 og OAT3.
English: Patients with baseline transaminase levels above the ULN had higher rates of transaminase elevations when taking cannabidiol.
Danish: Patienter med transaminaseniveauer ved baseline over ULN havde højere forekomst af transaminaseforhøjelser ved behandling med cannabidiol.
English: Lamotrigine levels may be elevated when it is co-administered with cannabidiol.
Danish: Lamotrigin-niveauerne kan være forhøjede ved administration samtidigt med cannabidiol.
English: No effects on cannabidiol or metabolite exposures were observed following administration of a single dose of cannabidiol 200 mg in subjects with mild hepatic impairment.
Danish: Der blev ikke observeret nogen virkninger på cannabidiol- eller metaboliteksponeringer efter administration af en enkelt dosis af cannabidiol 200 mg til forsøgspersoner med let nedsat leverfunktion.
English: The most commonly used cAEDs (> 25% of patients) in both trials were valproate, clobazam, stiripentol, and levetiracetam.
Danish: De mest almindeligt anvendte samtidige antiepileptika (> 25 % af patienterne) i begge forsøg var valproat, clobazam, stiripentol og levetiracetam.
English: If clinically significant increases of transaminases occur, cannabidiol and/or concomitant valproate should be reduced or discontinued in all patients until a recovery of transaminase elevations are observed (see section 4.4).
Danish: Hvis der forekommer klinisk signifikante forhøjelser af transaminaser, skal dosis af cannabidiol og/eller samtidigt administreret valproat reduceres eller seponeres hos alle patienter, indtil transaminaseforhøjelsen er svundet (se pkt.
English: Patients with identified baseline elevations of ALT or AST and patients who are taking valproate should have serum transaminases and total bilirubin levels obtained at 2 weeks, 1 month, 2 months, 3 months, and 6 months after initiation of treatment with cannabidiol, and periodically thereafter or as clinically indicated.
Danish: Patienter med påviste forhøjelser ved baseline af ALAT eller ASAT og patienter, som tager valproat, skal have fastlagt deres niveauer af serumtransaminaser og total bilirubin 2 uger, 1 måned, 2 måneder, 3 måneder og 6 måneder efter påbegyndelse af behandling med cannabidiol og periodisk derefter eller som klinisk indiceret.
English: The recommended starting dose of cannabidiol is 2.5 mg/kg taken twice daily (5 mg/kg/day) for one week.
Danish: Den anbefalede startdosis af cannabidiol er 2,5 mg/kg to gange dagligt (5 mg/kg/dag) i en uge.
English: Do not throw away any medicine in the wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: No effect on reproductive ability of male or female rats was noted with an oral dose of up to 150 mg/kg/day cannabidiol (see section 5.3).
Danish: Der blev ikke set nogen virkning på han- eller hunrotters reproduktionsevne med en oral dosis på op til 150 mg/kg/dag cannabidiol (se pkt.
English: A pre- and post-natal development study was performed in rats at doses of 75, 150, or 250 mg/kg/day.
Danish: Et studie af præ- og postnatal udvikling blev udført med rotter med doser på 75, 150 eller 250 mg/kg/dag.
English: Dose adjustments of other medicinal products used in combination with cannabidiol A physician experienced in treating patients who are on concomitant antiepileptic drugs (AEDs) should evaluate the need for dose adjustments of cannabidiol or of the concomitant medicinal product(s) to manage potential drug interactions (see sections 4.4 and 4.5).
Danish: Dosisjustering af andre lægemidler, som bruges i kombination med cannabidiol En læge med erfaring i behandling af patienter, som får samtidig behandling med antiepileptika, skal evaluere behovet for dosisjusteringer af cannabidiol eller af det eller de samtidigt administrerede lægemidler med henblik på håndtering af potentielle lægemiddelinteraktioner (se pkt.
English: The lowest dose causing developmental toxicity in juvenile rats (15 mg/kg subcutaneous/100 mg/kg oral) was associated with Cmax cannabidiol exposures approximately 20 times that in paediatric subjects at 20 mg/kg/day.
Danish: Den laveste dosis, der medførte udviklingsmæssig toksicitet hos juvenile rotter (15 mg/kg subkutant/100 mg/kg oralt), var forbundet med Cmax-cannabidioleksponeringer på ca.
English: Table 2: Tabulated list of adverse reactions
Danish: Tabel 2: Tabel over bivirkninger Systemorganklasse
English: What Epidyolex looks like and contents of the pack Epidyolex is a clear, colourless to yellow oral solution.
Danish: Epidyolex er en klar, farveløs til gul oral opløsning.
English: Open the bag containing the correct oral syringe to measure your dose.
Danish: Åbn posen med den sprøjte, du skal bruge til at afmåle din dosis.
English: Data for the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Danish: Data for undergruppen med clobazam præsenteres som en procent reduktion i forhold til baseline anslået ud fra en negativ binomial regressionsanalyse.
English: No adverse reactions were observed on male or female fertility or reproduction performance in rats at doses up to 250 mg/kg/day (approximately 60-fold greater than the maximum recommended human dose (MRHD) at 20 mg/kg/day).
Danish: Der blev ikke observeret negativ påvirkning af han- eller hundyrs fertilitet eller reproduktionsevne hos rotter ved doser på op til 250 mg/kg/dag (ca. 60 gange højere end den maksimalt anbefalede dosis for mennesker (MRHD) på 20 mg/kg/dag).
English: Strawberry flavour (including benzyl alcohol)
Danish: Jordbærsmag (herunder benzylalkohol)
English: Table 3: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in LGS studies
Danish: Tabel 3: Primære og vigtige sekundære resultatmål for ≥ 50 % respondere samt undergruppeanalyse i LGS-studier
English: Because of potential inhibition of enzyme activity, dose reduction of substrates of UGT1A9, UGT2B7, CYP2C8, and CYP2C9 should be considered, as clinically appropriate, if adverse reactions are experienced when administered concomitantly with cannabidiol.
Danish: På grund af den potentielle hæmning af enzymaktivitet bør det overvejes at reducere dosis af substrater af UGT1A9, UGT2B7, CYP2C8 og CYP2C9 som klinisk relevant, hvis der opleves bivirkninger ved administration samtidigt med cannabidiol.
English: Do not use this medicine after the expiry date shown on the bottle.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Table 5: Drug interactions between cannabidiol and concomitant antiepileptic drugs Concomitant AED Influence of AED on cannabidiol Influence of cannabidiol on AED Clobazam
Danish: Tabel 5: Lægemiddelinteraktioner mellem cannabidiol og samtidige antiepileptika Samtidigt antiepileptikum
English: The dose titration should be performed as detailed in the table below.
Danish: Dosistitrering skal ske i henhold til tabellen nedenfor.
English: Concomitant use of cannabidiol and clobazam increases the incidence of somnolence and sedation compared with placebo (see sections 4.4 and 4.8).
Danish: Samtidig brug af cannabidiol og clobazam øger forekomsten af døsighed og sedation sammenlignet med placebo (se pkt.
English: Very common Pyrexia, Fatigue
Danish: Pyreksi, træthed
English: - High liver enzymes (transaminases elevations) seen in blood tests, which can be a sign of liver injury, have been reported in patients receiving Epidyolex - People taking this medicine can have thoughts of harming or killing themselves.
Danish: - Højt antal leverenzymer (forhøjede transaminaser) som påvist i blodprøver, hvilket kan være tegn på leverskade, er blevet indberettet for patienter, der tager Epidyolex.
English: In individual patients titration up to a maximum dose of 20 mg/kg/day may be considered, based on the benefit-risk (see Section 4.2).
Danish: Hos den enkelte patient kan det overvejes at optitrere til en maksimal dosis på 20 mg/kg/dag på baggrund af benefit/risk-forholdet (se pkt.
English: ALT elevations greater than 3 times the ULN were reported in 16% of patients taking cannabidiol 20 mg/kg/day compared with 3% in patients taking cannabidiol 10 mg/kg/day.
Danish: Forhøjet ALAT over 3 gange ULN blev rapporteret hos 16 % af de patienter, der tog cannabidiol 20 mg/kg/dag, sammenlignet med 3 % af de patienter, der tog cannabidiol 10 mg/kg/dag.
English: GWPCARE3 Placebo 10 mg/kg/day 20 mg/kg/day GWPCARE4 Placebo 20 mg/kg/day Difference or Percent Reduction Compared with Placebo (95% CI), p-valueb
Danish: GWPCARE3 Placebo 10 mg/kg/dag 20 mg/kg/dag GWPCARE4 Placebo 20 mg/kg/dag Forskel eller procent reduktion sammenlignet med placebo (95 % CI), p-værdib
English: In the subgroup of LGS patients treated with concomitant clobazam for 37 to 48 weeks (N=161), the median percentage reduction from baseline in drop seizure frequency was 71% during Week 1-12, which was maintained through to Week 37-48, with a median percentage reduction from baseline in drop seizure frequency of 63%.
Danish: I undergruppen af LGS-patienter, som fik samtidig behandling med clobazam i 37 til 48 uger (n = 161), var den mediane procent reduktion i hyppigheden af anfald, som forårsager fald, i forhold til baseline 71 % i løbet af uge 1-12, og dette blev opretholdt frem til uge 37-48, med en median procent reduktion i hyppigheden af anfald, som forårsager fald, i forhold til baseline på 63 %.
English: Dose reduction of cannabidiol and/or the inhibitor may be necessary when given in combination.
Danish: Det kan være nødvendigt at reducere dosis af cannabidiol og/eller hæmmeren ved kombineret administration.
English: INFORMATION IN BRAILLE epidyolex
Danish: INFORMATION I BRAILLESKRIFT epidyolex