FrancophonIA/ELRC3.0 huggingface dataset:
English: • Frequently Asked Questions (FAQ) Patient Information Sheet (to be given to the patient): to provide patients with responses to some questions they might have about taking Xyrem.
Danish: • Ofte stillede spørgsmål (spørgsmål og svar), patient-sikkerhedskort (skal udleves til patienten): for at give patienter svar på nogle af de spørgsmål, de måtte have vedrørende anvendelse af Xyrem.
English: The first dose each night was taken at bedtime and the second dose was taken 2.5 to 4 hours later.
Danish: Hver nat blev den første dosis indtaget ved sengetid og den anden dosis blev indtaget 2,5 til 4 timer senere.
English: The rate of adverse reactions has increased when sodium oxybate is co-administered with tricyclic antidepressants.
Danish: Bivirkningsfrekvensen øges, når natriumoxybat administreres sammen med tricykliske antidepressiva.
English: Bradycardia and hypothermia may accompany unconsciousness, as well as muscular hypotonia, but tendon reflexes remain intact.
Danish: Bradykardi og hypotermi kan forekomme i forbindelse med bevidstløshed, lige så vel som muskulær hypotoni, men med intakte senereflekser.
English: Table 4 Summary of MWT in Trial 2
Danish: Tabel 4 Sammenfatning af MWT i studie 2
English: Narcolepsy is a sleep disorder that may include attacks of sleep during normal waking hours, as well as cataplexy, sleep paralysis, hallucinations and poor sleep.
Danish: Narkolepsi er en søvnforstyrrelse, som kan omfatte søvnanfald i normalt vågne timer samt katapleksi, søvnlammelse, hallucinationer og dårlig søvn.
English: Approximately 80% of patients who received sodium oxybate during clinical trials maintained CNS stimulant use.
Danish: Ca. 80 % af patienterne, som blev behandlet med natriumoxybat i kliniske studier, fortsatte brugen af CNS-stimulantia.
English: Sodium oxybate also has the potential to induce respiratory depression.
Danish: Natriumoxybat har også potentiale til at fremkalde respirationsdepression.
English: All patients with impaired renal function should consider a recommendation to reduce sodium intake (see section 4.4).
Danish: Alle patienter med nedsat nyrefunktion bør overveje anbefaling om reducering af natriumindtag (se pkt.
English: The pharmacokinetics of sodium oxybate in paediatric patients under the age of 18 years have not been studied.
Danish: Pædiatrisk population Farmakokinetikken for natriumoxybat i patienter yngre end 18 år er ikke undersøgt
English: In rabbits, slight foetotoxicity was observed.
Danish: Hos kaniner observeredes en vis fostertoksicitet.
English: • Gamma hydroxybutyrate (GHB) dehydrogenase inhibitors Caution is required in patients who are treated concomitantly with valproate or other GHB dehydrogenase inhibitors as pharmacokinetic and pharmacodynamic interactions have been observed when sodium oxybate is co-administered with valproate (see section 4.5).
Danish: • Gamma-hydroxybutyrat (GHB)-dehydrogenase-hæmmere Der skal udvises forsigtighed hos patienter, som samtidig behandles med valproat eller andre GHB-dehydrogenase-hæmmere, da der er set farmakokinetiske og farmakodynamiske interaktioner, når natriumoxybat administreres samtidigt med valproat (se pkt.
English: When you first start taking Xyrem, until you know whether it makes you sleepy the next day, use extreme care while driving a car, operating heavy machinery or doing anything else that could be dangerous or needs you to be fully mentally alert.
Danish: Når De begynder at tage Xyrem første gang og indtil De ved, om lægemidlet gør Dem søvnig næste dag, må De være yderst forsigtig, når De kører bil, betjener tunge maskiner eller foretager Dem andet, der kan være farligt eller kræver fuld mental årvågenhed.
English: Therefore, elderly patients should be monitored closely for impaired motor and/or cognitive function when taking sodium oxybate.
Danish: Ældre patienter bør derfor monitoreres nøje for hæmmet motorisk og/eller kognitiv funktion under behandling med natriumoxybat.
English: Increased sleepiness was observed after concomitant administration of sodium oxybate (2.25 g) and lorazepam (2 mg).
Danish: Øget søvnighed blev observeret efter samtidig administration af natriumoxybat (2,25 g) og lorazepam (2 mg).
English: There is very limited experience with sodium oxybate in the elderly.
Danish: Der er meget begrænset erfaring med behandling med natriumoxybat hos ældre patienter.
English: The co-administration of sodium oxybate (6 g per day) with valproate (1250 mg per day) resulted in an increase in systemic exposure to sodium oxybate by approximately 25% and no significant change in Cmax.
Danish: Samtidig administration af natriumoxybat (6 g pr. dag) med valproat (1.250 mg pr. dag) resulterede i en stigning i den systemiske eksponering for natriumoxybat med ca. 25 %, men ingen signifikant ændring i Cmax.
English: The use of haemodialysis and other forms of extracorporeal medicinal product removal have not been studied in sodium oxybate overdose.
Danish: Brug af hæmodialyse og andre metoder til ekstrakorporal lægemiddelelimination har ikke været undersøgt i forbindelse med natriumoxybatoverdosis.
English: If concomitant use is warranted, dose adjustment is to be considered (see section 4.2).
Danish: Hvis der er behov for samtidig administration, skal dosisjustering overvejes (se pkt.
English: When patients first start taking sodium oxybate, until they know whether this medicinal product will still have some carryover effect on them the next day, they should use extreme care while driving a car, operating heavy machines, or performing any other task that could be dangerous or require full mental alertness.
Danish: Når patienter starter med at tage natriumoxybat og indtil de ved, om dette lægemiddel har en hangover-effekt til næste dag, bør de udvise særlig forsigtighed, når de kører bil og betjener maskiner eller udfører enhver anden opgave, som kan være farlig eller kræver fuld mental opmærksomhed.
English: The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials.
Danish: Effekten ved ophør med natriumoxybat har ikke været systematisk evalueret i kontrollerede, kliniske studier.
English: If you take two 2.25 g doses of sodium oxybate each night you will take 0.82 g of sodium, or if you take two 4.5 g doses of sodium oxybate each night you will take in 1.6 g sodium.
Danish: Hvis De indtager to doser natriumoxybat på 2,25 g hver nat, får De 0,82 g natrium, og hvis De indtager to doser natriumoxybat på 4,5 g hver nat, får De 1,6 g natrium.
English: There have been clinical observation(s) of coma and increased plasma GHB concentration after co-administration of sodium oxybate with topiramate.
Danish: Der har været kliniske observationer af koma og forhøjet GBH-plasmakoncentration efter samtidig administration af natriumoxybat og topiramat.
English: Epworth Sleepiness Scale (ESS; range 0-24) Dose Group [g/d (n)] Baseline
Danish: Epworth Sleepiness Scale (ESS; range 0-24)
English: GHB dehydrogenase inhibitors
Danish: GHB-dehydrogenase-hæmmere
English: Xyrem contains the active substance sodium oxybate.
Danish: Xyrem indeholder det aktive stof natriumoxybat.
English: Patients may become confused while being treated with sodium oxybate.
Danish: Patienter kan blive konfuse under behandling med natriumoxybat.
English: Table 5 Summary of outcomes in Trial 3
Danish: Tabel 5 Sammenfatning af resultat i studie 3
English: Race The effect of race on metabolism of sodium oxybate has not been evaluated.
Danish: Race Raceeffekt på metabolisering af natriumoxybat er ikke undersøgt.
English: Instructions on how to dilute Xyrem
Danish: Instruktion i, hvordan Xyrem fortyndes
English: Sodium oxybate is a central nervous system depressant which reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy and modifies sleep architecture reducing fragmented nighttime sleep.
Danish: Natriumoxybat er et CNS-depressivt lægemiddel, som nedsætter udtalt søvnighed og katapleksi i dagtimerne hos patienter med narkolepsi og modificerer søvnmønsteret, hvilket reducerer afbrudt nattesøvn.
English: Patients should be routinely monitored and in the case of suspected abuse, treatment with sodium oxybate should be discontinued.
Danish: Patienterne bør monitoreres rutinemæssigt, og ved mistanke om misbrug bør natriumoxybat seponeres.
English: No effect on the pharmacokinetics of valproate was observed.
Danish: Der blev ikke observeret påvirkning af valproats farmakokinetik.
English: Take the first dose upon getting into bed and the second dose 2.5 to 4 hours later.
Danish: Tag den første dosis, når De går i seng, og den anden dosis 2½ til 4 timer senere.
English: Eye disorders Common: blurred vision
Danish: Øjne Almindelig: sløret syn
English: Do not use this medicine after the expiry date stated on the bottle after (EXP).
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: You may find that your cataplexy attacks return if your medicine is stopped and you may experience insomnia, headache, anxiety, dizziness, sleeping problems, sleepiness, hallucination and abnormal thinking.
Danish: De kan muligvis opleve, at Deres katapleksianfald vender tilbage, hvis Deres lægemiddelbehandling ophører, og De kan opleve søvnløshed, hovedpine, angst, svimmelhed, problemer med at sove, søvnighed, hallucinationer og unormal tankevirksomhed.
English: Each carton contains one bottle, a press-in bottle adaptor, a graduated measuring device (polypropylene syringe), two polypropylene dosing cups and two HDPE child resistant screw closures.
Danish: Hver karton indeholder én flaske, en flaskeadapter, en doseringsanordning med måleinddeling (polypropylensprøjte), to polypropylendoseringsbægre og to HDPE børnesikrede skruelåg.
English: • Additional risk minimisation measures The Marketing Authorisation Holder (MAH) shall develop an educational programme for Xyrem to ensure that physicians who intend to prescribe Xyrem are aware about the posology of Xyrem and about the important risks.
Danish: Indehaveren af markedsføringstilladelsen skal udvikle et uddannelsesprogram for Xyrem for at sikre, at læger, som planlægger at ordinere Xyrem, er bekendt med doseringen af Xyrem samt de vigtige risici ved Xyrem.
English: Table 2 Summary of ESS in Trial 1
Danish: Tabel 2 Sammenfatning af ESS i studie 1
English: No reversal of the central depressant effects of sodium oxybate can be expected from flumazenil administration.
Danish: Der kan ikke forventes ophævelse af den CNS-depressive effekt af natriumoxybat ved administration af flumazenil.
English: Patients taking sodium oxybate will have an additional daily intake of sodium that ranges from 0.82 g (for a 4.5 g/day Xyrem dose) to 1.6 g (for a 9 g/day Xyrem dose).
Danish: Patienter i behandling med natriumoxybat har et ekstra dagligt natriumindtag, som strækker sig fra 0,82 g (ved en Xyrem-dosis på 4,5 g/dag) til 1,6 g (ved en Xyrem-dosis på 9 g/dag).
English: General disorders and administration site conditions Common: asthenia, fatigue, feeling drunk, oedema peripheral
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig: asteni, træthed, følelse af at være fuld, perifere ødemer
English: Symptoms of Xyrem overdose may include agitation, confusion, impaired movement, impaired breathing, blurred vision, profuse sweating, headache, vomiting, decreased consciousness leading to coma and seizures excessive thirst, muscle cramps and weakness.
Danish: Symptomerne ved overdosering af Xyrem kan omfatte ophidselse, forvirring, svækket bevægelighed, svækket vejrtrækning, sløret syn, voldsomme svedeture, hovedpine, opkastning, nedsat bevidsthed, der fører til koma og krampeanfald, overdreven tørst, muskelkramper og mathed.
English: After removing the cap, set the bottle upright on a table-top.
Danish: Når låget er fjernet, sættes flasken i opret stilling på et bord.
English: Events associated with withdrawal syndrome have been observed outside the therapeutic range.
Danish: Abstinenssymptomer er observeret uden for det terapeutiske interval.
English: If you experience any of these, tell your doctor straight away.
Danish: Hvis De bemærker nogen form for bivirkninger, skal De omgående fortælle det til Deres læge.
English: The primary pathway involves a cytosolic NADP+-linked enzyme, GHB dehydrogenase, that catalyses the conversion of sodium oxybate to succinic semialdehyde, which is then biotransformed to succinic acid by the enzyme succinic semialdehyde dehydrogenase.
Danish: +-forbundet enzym, GHB-dehydrogenase, som katalyserer omdannelsen af natriumoxybat til succinylsemialdehyd, som derefter biotransformeres til succinylsyre af enzymet succinylsemialdehyddehydrogenase.
English: Sodium oxybate was non-mutagenic and non-clastogenic in in vitro and in vivo assays.
Danish: Natriumoxybat var ikke-mutagent og ikke-klastogent i in vitro- og in vivo-studier.
English: Not known: suicidal ideation, homicidal ideation, aggression, euphoric mood, sleep-related eating disorder, panic attack, mania / bipolar disorder, delusion, bruxism, irritability and increased libido
Danish: Ikke kendt: suicidale tanker, drabstanker, aggression, eufori, søvnrelateret spiseforstyrrelse, panikanfald, mani/bipolar lidelse, vrangforestillinger, bruksisme, irritabilitet og øget libido
English: The safety and efficacy of sodium oxybate for the treatment of narcolepsy symptoms was established in four multicentre, randomised, double-blind, placebo-controlled, parallel-group trials in patients with narcolepsy with cataplexy except for one trial where cataplexy was not required for enrolment.
Danish: Natriumoxybats sikkerhed og virkning til behandling af narkolepsisymptomer blev dokumenteret i fire randomiserede, dobbeltblinde, placebokontrollerede multicenterstudier med parallelle grupper med patienter, der havde narkolepsi med katapleksi med undtagelse af ét studie, hvor katapleksi ikke var et inklusionskriterium.
English: The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials (see section 4.4).
Danish: Effekten ved ophør med natriumoxybat har ikke været systematisk evalueret i kontrollerede, kliniske studier (se pkt.
English: Sodium Oxybate should not be used during breastfeeding.
Danish: Natriumoxybat bør ikke anvendes under amning.
English: Patients should be warned against the use of any alcoholic beverages in conjunction with sodium oxybate.
Danish: Patienter bør advares mod indtagelse af enhver form for alkoholisk drik i forbindelse med natriumoxybat.
English: Do not take Xyrem - if you are allergic to sodium oxybate or any of the other ingredients of this medicine (listed in section 6); - if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder); - if you suffer from major depression; - if you are being treated with opioid or barbiturate medicines.
Danish: (angivet i afsnit 6), - hvis De lider af succin-semialdehyd-dehydrogenase-mangel (en sjælden stofskiftesygdom), - hvis De lider af svær depression, - hvis De er i behandling med opioider eller barbiturater.
English: The co-administration of omeprazole has no clinically significant effect on the pharmacokinetics of sodium oxybate.
Danish: Samtidig administration af omeprazol har ingen klinisk signifikant effekt på natriumoxybats farmakokinetik.
English: No additional effect on sleepiness was observed when comparing single doses of sodium oxybate alone (2.25 g) and sodium oxybate (2.25 g) in combination with duloxetine (60 mg at steady state).
Danish: Der sås ingen additiv effekt på søvnighed, når man sammenlignede enkeltdoser af natriumoxybat alene (2,25 g) og natriumoxybat (2,25 g) i kombination med duloxetin (60 mg ved steady state).
English: Cardiac disorders Common: palpitations
Danish: Hjerte Almindelig: palpitationer
English: What Xyrem looks like and contents of the pack Xyrem is supplied in a 240 mL amber plastic bottle containing 180 mL of oral solution and closed with a child-resistant cap.
Danish: Xyrem leveres i en 240 ml brun plastflaske indholdende 180 ml oral opløsning, som er lukket med børnesikret låg.
English: Table 6 Summary of outcome in Trial 4
Danish: Tabel 6 Sammenfatning af resultat i studie 4
English: Xyrem 500 mg/mL oral solution
Danish: Xyrem 500 mg/ml oral opløsning.
English: Sodium oxybate is not recommended during pregnancy.
Danish: Natriumoxybat bør ikke anvendes under graviditet.
English: A recommendation to reduce sodium intake should be carefully considered in the management of patients with heart failure, hypertension or compromised renal function (see sections 4.2 and 4.9).
Danish: Anbefaling om at reducere natriumindtag bør nøje overvejes ved behandling af patienter med hjertesvigt, hypertension eller nedsat nyrefunktion (se pkt.
English: The recommended starting dose is 4.5 g/day, given as two equally divided doses of 2.25 g/dose.
Danish: Den anbefalede begyndelsesdosis er 4,5 g/dag givet som to lige store doser på hver 2,25 g/dosis.
English: The recommended starting dose for sodium oxybate, when used concomitantly with valproate, is 3.6 g/day administered orally in two equal divided doses of approximately 1.8 g. If concomitant use is warranted, patient response and tolerability should be monitored and dose should be adapted accordingly (see section 4.4)
Danish: Når natriumoxybat og valproat administreres samtidigt, er den anbefalede startdosis 3,6 g natriumoxybat/dag, som administreres oralt fordelt på to lige store doser a ca. 1,8 g. Hvis der er behov for samtidig behandling med natriumoxybat og valproat, bør patientens respons og tolerabilitet monitoreres og dosis tilpasses i overensstemmelse hermed (se pkt.
English: Therefore, patients should be warned against the use of alcohol in conjunction with sodium oxybate.
Danish: Derfor bør patienter advares mod at indtage alkohol sammen med natriumoxybat.
English: Dose Group
Danish: Dosisgruppe
English: What Xyrem contains - The active substance is sodium oxybate.
Danish: Xyrem indeholder - Aktivt stof: natriumoxybat.
English: Common: depression, cataplexy, anxiety, abnormal dreams, confusional state, disorientation, nightmares, sleepwalking, sleep disorder, insomnia, middle insomnia, nervousness Uncommon: suicide attempt, psychosis, paranoia, hallucination, abnormal thinking, agitation, initial insomnia
Danish: Almindelig: depression, katapleksi, angst, unormale drømme, konfusionstilstand, desorientering, mareridt, søvngængeri, søvnproblemer, søvnløshed, middelsvær søvnløshed, nervøsitet Ikke almindelig: suicidalforsøg, psykose, paranoia, hallucinationer, abnorm tankegang, agitation, initial søvnløshed
English: Xyrem is provided for use with a graduated measuring syringe and two 90 mL dosing cups with child resistant caps.
Danish: Xyrem leveres med en målesprøjte med måleinddeling og to 90 ml doseringsbægre med børnesikret låg.
English: Faecal excretion is negligible.
Danish: Fækal elimination er minimal.
English: When higher doses up to 9 g/day of sodium oxybate are combined with higher doses of opioids (within the recommended dose range) pharmacodynamic interactions associated with symptoms of CNS depression and/or respiratory depression cannot be excluded (see sections 4.3).
Danish: Når højere doser på op til 9 g natriumoxybat/dag kombineres med højere doser opioider (inden for det anbefalede dosisinterval) kan farmakodynamiske interaktioner med symptomer på CNS-depression og/eller respirationsdepression ikke udelukkes (se pkt.
English: Before increasing the sodium oxybate dose (see section 4.2), prescribers should be aware that sleep apnoea occurs in up to 50% of patients with narcolepsy.
Danish: 4.2) bør den ordinerende læge være opmærksom på, at søvnapnø forekommer hos op til 50 % af patienter med narkolepsi.
English: The recommended starting dose for Xyrem, when used together with valproate, is 3.6 g/day, given as two equally divided doses of 1.8 g. Take the first dose upon getting into bed and the second dose 2.5 to 4 hours later.
Danish: Når Xyrem tages sammen med valproat, er den sædvanlige begyndelsesdosis af Xyrem 3,6 g/dag givet som to lige store doser på hver 1,8 g. Tag den første dosis ved sengetid og den anden dosis 2½ til 4 timer senere.
English: The starting dose should be halved in all patients with hepatic impairment, and response to dose increments monitored closely (see section 4.2).
Danish: Den initiale dosis bør halveres til alle patienter med nedsat leverfunktion, og respons på dosisøgninger skal monitoreres nøje (se pkt.
English: Sleeping problems including insomnia, blurred vision, feeling the heartbeat, vomiting, stomach pains, diarrhoea, anorexia, decreased appetite, weight loss, weakness, abnormal dreams, tiredness, feeling drunk, sleep paralysis, sleepiness, trembling, confusion/ disorientation, nightmares, sleep walking, bed wetting, sweating, depression, muscle cramps, swelling, fall, joint pain, back pain, excessive daytime sleepiness, balance disorder, disturbance in attention, decreased sensitivity particularly to touch, abnormal touch sensation, feeling of “pins and needles” (part of the body (typically a foot or hand) begins to tingle and becomes numb, or"falls asleep" sedation, abnormal taste, anxiety, difficulty in falling asleep in the middle of the night, nervousness, feeling of “spinning” (vertigo), urinary incontinence, shortness of breath, snoring, congestion of the nose, rash, inflammation of the sinuses, inflammation of nose and throat, increased blood pressure
Danish: Søvnproblemer herunder søvnløshed, sløret syn, hjertebanken, opkastning, mavesmerter, diarré, anoreksi, nedsat appetit, vægttab, mathed, unormale drømme, træthed, følelse af beruselse, søvnlammelse, søvnighed, rystelser, forvirring/desorientering, mareridt, søvngængeri, sengevædning, svedeture, depression, muskelkramper, hævelse, faldtendens, ledsmerter, rygsmerter, overdreven søvnighed i dagtimerne, balanceforstyrrelser, opmærksomhedsforstyrrelser, nedsat følsomhed over for berøring, unormal følsomhed ved berøring, følelse af "prikken og stikken" (en del af kroppen (typisk en fod eller en hånd) begynder at snurre og bliver følelsesløs eller "falder i søvn"), sløvhed, smagsforstyrrelser, angst, problemer med at falde i søvn midt om natten, nervøsitet, følelse af at ”snurre rundt” (svimmelhed), ufrivillig vandladning, åndenød, snorken, tilstoppet næse, udslæt, bihulebetændelse, betændelse i næse og svælg, forhøjet blodtryk.
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and ibuprofen.
Danish: Lægemiddelinteraktionsstudier hos raske voksne viste ingen farmakokinetiske interaktioner mellem natriumoxybat og ibuprofen.
English: Elderly patients should be monitored closely for impaired motor and/or cognitive function when taking sodium oxybate (see section 4.4).
Danish: Ældre patienter skal monitoreres nøje for hæmning af motoriske og/eller kognitive funktioner under behandling med natriumoxybat (se pkt.
English: Ask your pharmacist how to dispose of medicines you no longer use.
Danish: Spørg på apoteket, hvordan De skal aflevere medicinrester.
English: When higher doses up to 9 g/d of sodium oxybate are combined with higher doses of hypnotics (within the recommended dose range) pharmacodynamic interactions associated with symptoms of CNS depression and/or respiratory depression cannot be excluded (see section 4.3).
Danish: Når højere doser på op til 9 g natriumoxybat/dag kombineres med højere doser hypnotikum (inden for det anbefalede dosisinterval) kan farmakodynamiske interaktioner med symptomer på CNS-depression og/eller respirationsdepression ikke udelukkes (se pkt.
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and diclofenac.
Danish: Lægemiddelinteraktionsstudier hos raske voksne viste ingen farmakokinetiske interaktioner mellem natriumoxybat og diclofenac.
English: Remove the cap from the first dosing cup by pressing down on the childresistant locking tab and turning the cap anticlockwise (to the left).
Danish: Fjern låget fra det første doseringsbæger ved at trykke den børnesikre låsetap ned og drej låget mod uret (mod venstre).