natgillin/translations-raw huggingface dataset:
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). 
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).
Almene symptomer og reaktioner på administrationsstedet Almindelig: asteni, træthed, følelse af at være fuld, perifere ødemer 
General disorders and administration site conditions Common: asthenia, fatigue, feeling drunk, oedema peripheral
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. 
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.
Når låget er fjernet, sættes flasken i opret stilling på et bord. 
After removing the cap, set the bottle upright on a table-top.
Abstinenssymptomer er observeret uden for det terapeutiske interval. 
Events associated with withdrawal syndrome have been observed outside the therapeutic range.
Hvis De bemærker nogen form for bivirkninger, skal De omgående fortælle det til Deres læge. 
If you experience any of these, tell your doctor straight away.
+-forbundet enzym, GHB-dehydrogenase, som katalyserer omdannelsen af natriumoxybat til succinylsemialdehyd, som derefter biotransformeres til succinylsyre af enzymet succinylsemialdehyddehydrogenase. 
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.
Natriumoxybat var ikke-mutagent og ikke-klastogent i in vitro- og in vivo-studier. 
Sodium oxybate was non-mutagenic and non-clastogenic in in vitro and in vivo assays.
Ikke kendt: suicidale tanker, drabstanker, aggression, eufori, søvnrelateret spiseforstyrrelse, panikanfald, mani/bipolar lidelse, vrangforestillinger, bruksisme, irritabilitet og øget libido 
Not known: suicidal ideation, homicidal ideation, aggression, euphoric mood, sleep-related eating disorder, panic attack, mania / bipolar disorder, delusion, bruxism, irritability and increased libido
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. 
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.
Effekten ved ophør med natriumoxybat har ikke været systematisk evalueret i kontrollerede, kliniske studier (se pkt. 
The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials (see section 4.4).
Natriumoxybat bør ikke anvendes under amning. 
Sodium Oxybate should not be used during breastfeeding.
Patienter bør advares mod indtagelse af enhver form for alkoholisk drik i forbindelse med natriumoxybat. 
Patients should be warned against the use of any alcoholic beverages in conjunction with sodium oxybate.
(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. 
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.
Samtidig administration af omeprazol har ingen klinisk signifikant effekt på natriumoxybats farmakokinetik. 
The co-administration of omeprazole has no clinically significant effect on the pharmacokinetics of sodium oxybate.
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). 
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).
Hjerte Almindelig: palpitationer 
Cardiac disorders Common: palpitations
Xyrem leveres i en 240 ml brun plastflaske indholdende 180 ml oral opløsning, som er lukket med børnesikret låg. 
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.
Tabel 6 Sammenfatning af resultat i studie 4 
Table 6 Summary of outcome in Trial 4
Xyrem 500 mg/ml oral opløsning. 
Xyrem 500 mg/mL oral solution
Natriumoxybat bør ikke anvendes under graviditet. 
Sodium oxybate is not recommended during pregnancy.
Anbefaling om at reducere natriumindtag bør nøje overvejes ved behandling af patienter med hjertesvigt, hypertension eller nedsat nyrefunktion (se pkt. 
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).
Den anbefalede begyndelsesdosis er 4,5 g/dag givet som to lige store doser på hver 2,25 g/dosis. 
The recommended starting dose is 4.5 g/day, given as two equally divided doses of 2.25 g/dose.
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. 
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)
Derfor bør patienter advares mod at indtage alkohol sammen med natriumoxybat. 
Therefore, patients should be warned against the use of alcohol in conjunction with sodium oxybate.
Dosisgruppe 
Dose Group
Xyrem indeholder - Aktivt stof: natriumoxybat. 
What Xyrem contains - The active substance is sodium oxybate.
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 
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
Xyrem leveres med en målesprøjte med måleinddeling og to 90 ml doseringsbægre med børnesikret låg. 
Xyrem is provided for use with a graduated measuring syringe and two 90 mL dosing cups with child resistant caps.
Fækal elimination er minimal. 
Faecal excretion is negligible.
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. 
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).
4.2) bør den ordinerende læge være opmærksom på, at søvnapnø forekommer hos op til 50 % af patienter med narkolepsi. 
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.
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. 
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.
Den initiale dosis bør halveres til alle patienter med nedsat leverfunktion, og respons på dosisøgninger skal monitoreres nøje (se pkt. 
The starting dose should be halved in all patients with hepatic impairment, and response to dose increments monitored closely (see section 4.2).
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. 
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
Lægemiddelinteraktionsstudier hos raske voksne viste ingen farmakokinetiske interaktioner mellem natriumoxybat og ibuprofen. 
Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and ibuprofen.
Ældre patienter skal monitoreres nøje for hæmning af motoriske og/eller kognitive funktioner under behandling med natriumoxybat (se pkt. 
Elderly patients should be monitored closely for impaired motor and/or cognitive function when taking sodium oxybate (see section 4.4).
Spørg på apoteket, hvordan De skal aflevere medicinrester. 
Ask your pharmacist how to dispose of medicines you no longer use.
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. 
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).
Lægemiddelinteraktionsstudier hos raske voksne viste ingen farmakokinetiske interaktioner mellem natriumoxybat og diclofenac. 
Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and diclofenac.
Fjern låget fra det første doseringsbæger ved at trykke den børnesikre låsetap ned og drej låget mod uret (mod venstre). 
Remove the cap from the first dosing cup by pressing down on the childresistant locking tab and turning the cap anticlockwise (to the left).
Luftveje, thorax og mediastinum Almindelig: dyspnø, snorken, nasal kongestion Ikke kendt: respirationsdepression, søvnapnø 
Respiratory, thoracic and mediastinal disorders Common: dyspnoea, snoring, nasal congestion Not known: respiratory depression, sleep apnoea
Kombineret brug af alkohol og natriumoxybat kan resultere i forstærkning af natriumoxybats CNSdepressive virkning. 
The combined use of alcohol with sodium oxybate may result in potentiation of the central nervous system-depressant effects of sodium oxybate.
Knogler, led, muskler og bindevæv Almindelig: artralgi, muskelspasmer, rygsmerter 
Musculoskeletal and connective tissue disorders Common: arthralgia, muscle, spasms, back pain
Tag altid Xyrem nøjagtigt efter lægens eller apotekspersonalets anvisning. 
Always take this medicine exactly as your doctor or pharmacist has told you.
Derfor bør patienter advares mod at bruge topiramat sammen med natriumoxybat (se pkt. 
Therefore, patients should be warned against the use of topiramate in conjunction with sodium oxybate (section 4.5).
Som en hjælp indeholder Xyrem-æsken 1 flaske lægemiddel, en målesprøjte og to doseringsbægre med børnesikkert låg. 
To help you, the Xyrem carton contains 1 bottle of medicine, a measuring syringe and two dosing cups with child-resistant caps.
Apnø og respirationsdepression har været observeret hos fastende raske personer efter et enkelt indtag på 4,5 g (det dobbelte af den anbefalede startdosis) Patienter bør udspørges angående tegn på depression af centralnervesystemet (CNS) eller respirationsdepression. 
Apnoea and respiratory depression have been observed in a fasting healthy subject after a single intake of 4.5 g (twice the recommended starting dose).
Selv om erfaring fra kliniske studier med natrium oxybat til narkolepsi-/katapleksipatienter i terapeutiske doser ikke udviser klar evidens for abstinenssymptomer, er der i sjældne tilfælde observeret episoder med insomnia, hovedpine, angst, svimmelhed, søvnforstyrrelser, somnolens, hallucinationer og psykotiske lidelser efter ophør med GHB. 
Although the clinical trial experience with sodium oxybate in narcolepsy/cataplexy patients at therapeutic doses does not show clear evidence of a withdrawal syndrome, in rare cases, events such as insomnia, headache, anxiety, dizziness, sleep disorder, somnolence, hallucination, and psychotic disorders were observed after GHB discontinuation.
Er De i tvivl, så spørg lægen eller på apoteket. 
- If you have any further questions, ask your doctor or your pharmacist.
Ophør med Xyrem-behandlingen 
Discontinuation of Xyrem
Xyrem 500 mg/ml oral opløsning Natriumoxybat 
Xyrem 500 mg/mL oral solution Sodium oxybate
Flaskelåget fjernes ved at trykke det ned, mens det drejes mod uret (mod venstre). 
Remove the bottle cap by pushing down while turning the cap anticlockwise (to the left).
Der er rapporteret søvngængeri hos patienter, som i kliniske studier er behandlet med natriumoxybat. 
Sleepwalking has been reported in patients treated in clinical trials with sodium oxybate.
Lægemiddelinteraktionsstudier hos raske voksne viste ingen farmakokinetiske interaktioner mellem natriumoxybat (enkelt dosis på 2,25 g) og de 2 antidepressiva protriptylinhydrochlorid (enkelt dosis på 10 mg) og duloxetin (60 mg ved steady state). 
Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate (single dose of 2.25 g) and the antidepressants protriptyline hydrochloride (single dose of 10 mg) and duloxetine (60 mg at steady state).
Et interaktionsstudie hos raske voksne viste ingen farmakokinetisk interaktion mellem natriumoxybat (enkelt dosis på 4,5 g) og modafinil (enkelt dosis på 200 mg). 
A drug interaction study in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate (single dose of 4.5 g) and modafinil (single dose of 200 mg).
Kramper, nedsat vejrtrækningsdybde eller -hastighed, nældefeber, selvmordstanker, kortvarige vejrtrækningspauser under søvn, eufori, mundtørhed, hævet ansigt (angioødem), dehydrering, panikanfald, mani/bipolar lidelse, vrangforestilling, bruksisme (tænderskæren og knytten kæbe), pollakisuri/imperiøs vandladning (hyppig vandladning), nykturi (overdreven vandladning om natten), tinnitus (ringen og susen for ørerne), søvnrelateret spiseforstyrrelse, tab af bevidsthed, øget appetit, irritabilitet, aggression, dyskinesi (f.eks. unormale, ufrivillige bevægelser af lemmerne) og tanker om at begå voldelige handlinger (herunder at skade andre), skæl og øget seksualadfærd. 
Convulsion, decreased breathing depth or rate, hives, suicidal thoughts, short cessation of breathing during sleep, euphoric mood, dry mouth, swelling face (angioedema), dehydration, panic attack, mania / bipolar disorder, delusion, bruxism (teeth grinding and jaw clenching), pollakiuria / micturition urgency (increase need to urinate), nocturia (excessive urination at night), tinnitus (noise in the ears such as ringing or buzzing) sleep-related eating disorder, loss of consciousness, increased appetite, irritability, aggression, dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) and thoughts of committing violent acts (including harming others), dandruff and increased sexual desire
Natriumoxybats effektivitet til behandling af narkolepsisymptomer, blev dokumenteret i fire randomiserede, dobbeltblinde, placebokontrollerede multicenterstudier med parallelle grupper (studie 1, 2, 3 og 4) med patienter, der havde narkolepsi med katapleksi, en undtagelse var studie 2, hvor katapleksi ikke var et inklusionskrav. 
The effectiveness of sodium oxybate for the treatment of narcolepsy symptoms was established in four multicentre, randomised, double-blind, placebo-controlled, parallel-group trials (Trial 1, 2, 3 and 4) in patients with narcolepsy with cataplexy except for trial 2 where cataplexy was not required for enrolment Concomitant stimulant use was permitted in all trials (except for the active-treatment phase of Trial 2); antidepressants were withdrawn prior to active treatment in all trials with the exception of Trial 2.
CGIc - Clinical Global Impression of Change (klinisk global vurdering af ændring); FOSQ - Functional Outcomes of Sleep Questionnaire (funktionelle resultater fra spørgeskema om søvn) 
EDS - Excessive daytime sleepiness; ESS - Epworth Sleepiness Scale; MWT - Maintenance of Wakefulness Test; Naps - Number of inadvertent daytime naps; CGIc - Clinical Global Impression of Change; FOSQ - Functional Outcomes of Sleep Questionnaire
Krampeanfald er set hos patienter behandlet med natriumoxybat. 
Seizures have been observed in patients treated with sodium oxybate.
• Topiramat 
• Topiramate
Et interaktionsstudie hos raske voksne med natriumoxybat (enkelt dosis på 2,25 g) og tramadol (enkelt dosis på 100 mg) viste ingen farmakokinetisk/farmakodynamisk interaktion. 
A drug interaction study in healthy adults with sodium oxybate (single dose of 2.25 g) and tramadol (single dose of 100 mg) demonstrated no pharmacokinetic/pharmacodynamic interaction.
Hver ml indeholder 500 mg natriumoxybat. 
Each mL contains 500 mg of sodium oxybate.
Lægemiddelinteraktionsstudier hos raske voksne med natriumoxybat (enkelt dosis på 2,25 g) og lorazepam (enkelt dosis på 2 mg) og zolpidemtartrat (enkelt dosis på 5 mg) viste ingen farmakokinetiske interaktioner. 
Drug interaction studies in healthy adults with sodium oxybate (single dose of 2.25 g) and lorazepam (single dose of 2 mg) and zolpidem tartrate (single dose of 5 mg) demonstrated no pharmacokinetic interactions.
4.4) til en maksimal dosis på 9 g/dag fordelt på to lige store doser á 4,5 g ved op-eller nedjustering i intervaller på 1,5 g/dag (dvs. 0,75 g/dosis). 
The dose should be titrated to effect based on efficacy and tolerability (see section 4.4) up to a maximum of 9 g/day divided into two equal doses of 4.5 g/dose by adjusting up or down in dose increments of 1.5 g/day (i.e. 0.75 g/dose).
Efter fortynding i doseringsbægeret, skal opløsningen indtages inden for 24 timer. 
After dilution in the dosing cups, the preparation should be used within 24 hours.
Efter fortynding i doseringsbægrene skal opløsningen indtages inden for 24 timer. 
After dilution in the dosing cups the preparation should be used within 24 hours.
Psykose (en mental lidelse, som kan medføre hallucinationer, usammenhængende tale eller desorienteret og ophidset opførsel), paranoia, unormal tankevirksomhed, hallucinationer, ophidselse, 
Psychosis (a mental disorder that may involve hallucinations, incoherent speech, or disorganized and agitated behaviour), paranoia, abnormal thinking, hallucination, agitation, suicide attempt, difficulty in falling asleep, restless legs, forgetfulness, myoclonus (involuntary contractions of muscles), involuntary passage of faeces, hypersensitivity
• Alkohol og CNS-supprimerende lægemidler Kombineret brug af alkohol eller ethvert CNS-supprimerende lægemiddel og natriumoxybat kan resultere i potensering af natriumoxybats CNS-supprimerende virkning. 
The combined use of alcohol, or any CNS -depressant medicinal product, with sodium oxybate may result in potentiation of the CNS-depressant effects of sodium oxybate as well as increased risk of respiratory depression.
Hver ml opløsning indeholder 500 mg natriumoxybat. 
Each mL of solution contains 500 mg of sodium oxybate.
Hver ml opløsning indeholder 500 mg natriumoxybat 
Each mL of solution contains 500 mg sodium oxybate
Behandlingsgruppe 
Treatment Group Number of Subjects
Opbevaringsforhold efter fortynding af lægemidlet, se pkt. 
For storage conditions after first opening of the medicinal product, see section 6.3 For storage conditions after dilution of the medicinal product, see section 6.3.
Sekundær effekt 
Possible side effects
Brug af Xyrem er kontraindiceret til patienter med major depression (pkt. 
Major depression is contraindicated for use with Xyrem (section 4.3).
Da der har været klinisk(e) observation(er) af koma og forhøjet GBH-plasmakoncentration hos patienter efter samtidig administration af natriumoxybat og topiramat, kan mulige farmakodynamiske og farmakokinetiske interaktioner ikke udelukkes ved samtidig administration af natriumoxybat og topiramat (se pkt. 
Possible pharmacodynamic and pharmacokinetic interactions when sodium oxybate is used concomitantly with topiramate cannot be excluded as clinical observation(s) of coma, and increased plasma GHB concentration were reported in a patient(s) under concomitant use of sodium oxybate and topiramate (section 4.4).
Ventrikelskylning bør overvejes ved mistanke om samtidig indtagelse af andre stoffer. 
Gastric lavage may be considered if co-ingestants are suspected.
Ikke kendt: urticaria, angioødem, seborrhea 
Not known: pollakiuria / micturition urgency, nocturia
Almindelig: søvn paralyse, somnolens, tremor, balanceproblemer, opmærksomhedsforstyrrelser, hypæstesi, paræstesi, sedation, dysgeusi 
Common: sleep paralysis, somnolence, tremor, balance disorder, disturbance in attention, hypoesthesia, paraesthesia, sedation, dysgeusia Uncommon: myoclonus, amnesia, restless legs syndrome Not known: convulsion, loss of consciousness, dyskinesia