FrancophonIA/ELRC3.0 huggingface dataset:
English: Gamma Butyrolactone (GBL), a pro-drug of GHB tested at exposures similar to the expected in man (1.21-1.64 times) has been classified by NTP as non-carcinogenic in rats and equivocal carcinogen in mice, due to slight increase of pheochromocytomas which was difficult to interpret due to high mortality in the high dose group.
Danish: Gamma Butyrolacton (GBL), en pro-drug til GHB, som testedes ved eksponering svarende til den, som forventedes i mennesker (1,21-1,64 gange), er klassifiseret ved NTP som ikke-karcinogent hos rotter og muligvis karcinogent hos mus, på grund af en lille stigning i fæokromocytom, som var vanskelig at tyde på grund af høj dødelighed i højdosisgruppen.
English: Cases of dependency have occurred after the illicit use of sodium oxybate.
Danish: Der er konstateret tilfælde af afhængighed efter ulovlig brug af natriumoxybat.
English: Infections and infestations Common: nasopharyngitis, sinusitis
Danish: Infektioner og parasitære sygdomme Almindelig: nasopharyngitis, sinusitis
English: The clearance of sodium oxybate is almost entirely by biotransformation to carbon dioxide, which is then eliminated by expiration.
Danish: Udskillelse af natriumoxybat foregår næsten udelukkende ved biotransformation til kuldioxid, som derefter elimineres ved ekspiration.
English: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine l'Alleud, Belgium Or
Danish: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine l'Alleud, Belgien Eller
English: Xyrem should be taken orally upon getting into bed and again between 2.5 to 4 hours later.
Danish: Xyrem bør indtages oralt ved sengetid og igen 2,5 til 4 timer senere.
English: Table 3 Summary of CGI-c in Trial 1
Danish: Tabel 3 Sammenfatning af CGI-c i studie 1
English: Epileptic patients
Danish: Epilepsipatienter
English: Other neuropsychiatric events include anxiety, psychosis, paranoia, hallucinations, and agitation.
Danish: Andre neuropsykiatriske forhold inkluderer angst, psykose, paranoia, hallucinationer og agitation.
English: Patients taking Xyrem should not breast feed since it is known that Xyrem passes into breast milk.
Danish: Patienter, der tager Xyrem, bør ikke amme, da man ved, at Xyrem udskilles i modermælken.
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium
Danish: Indehaver af markedsføringstilladelsen UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgien
English: One bottle of 180 mL oral solution
Danish: En 180 ml flaske oral opløsning
English: Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away.
Danish: Drik hele den første dosis, mens De sidder i sengen, sæt låget på igen, og læg Dem straks ned.
English: The MAH has established a controlled distribution program that enhances existing controls for Xyrem to allow reaching the intended population of narcolepsy patients while minimizing the risk of Xyrem being diverted by those seeking to misuse it.
Danish: Indehaveren af markedsføringstilladelsen har etableret et kontrolleret distributionsprogram, der forbedrer de eksisterende kontroller for Xyrem, og som gør det muligt at nå målgruppen af narkolepsipatienter og samtidig minimerer risikoen for, at Xyrem når personer, som søger at misbruge det.
English: Median Change from Baseline
Danish: Median af afvigelse fra baseline
English: The sodium oxybate or placebo equivalent dose was 6 g/day for the first 4 weeks and was increased to 9 g/day for the remaining 4 weeks.
Danish: Natriumoxybatdosis og den ækvivalerende placebodosis var på 6 g/dag de første 4 uger og blev øget til 9 g/dag i de resterende 4 uger.
English: Changes in sleep patterns have been observed in breastfed infants from exposed mothers, which may be consistent with the effects of sodium oxybate on the nervous system.
Danish: Ændringer i søvnmønster er observeret hos ammede spædbørn fra eksponerede mødre, som kan være konsistent med natriumoxybats påvirkninger af nervesystemet.
English: Two Phase 3 and one Phase 2 double-blind, parallel-group, placebo-controlled studies were performed to assess the indication of sodium oxybate for fibromyalgia.
Danish: Der blev også udført to fase 3 og et fase 2 dobbeltblinde, placebokontrollerede studier med parallelle grupper for at vurdere natriumoxybat til indikationen fibromyalgi.
English: If you have kidney problems, you should consider a dietary recommendation to reduce sodium intake.
Danish: Hvis De har nyreproblemer, skal De overveje en diæt med henblik på at nedsætte Deres indtagelse af natrium.
English: - The other ingredients are purified water, malic acid and sodium hydroxyde.
Danish: - Øvrige indholdsstoffer: renset vand, æblesyre og natriumhydroxid.
English: Each measured dose of Xyrem must be dispensed into the dosing cup and diluted with 60 mL of water prior to ingestion.
Danish: Hver afmålt dosis Xyrem skal hældes i doseringsbægret og fortyndes med 60 ml vand før indtagelsen.
English: Sedative hypnotics
Danish: Sedativa og hypnotika
English: While holding the bottle in its upright position, insert the press-in-bottle-adaptor into the neck of the bottle.
Danish: Mens flasken holdes i opret stilling, indsættes flaskeadapteren i flaskehalsen.
English: Sodium oxybate administered before nocturnal sleep increases Stages 3 and 4 sleep and increases sleep latency, whilst reducing the frequency of sleep onset REM periods (SOREMPs).
Danish: Natriumoxybat, administreret før nattesøvnen, øger søvnstadie 3 og 4 og øger søvnlatens, mens det reducerer frekvensen af sleep onset REM-perioder (SOREMPs).
English: If a patient experiences urinary or faecal incontinence during sodium oxybate therapy, the prescriber should consider pursuing investigations to rule out underlying aetiologies.
Danish: Hvis en patient oplever inkontinens for urin eller afføring under natriumoxybatbehandling, bør den ordinerende læge tilstræbe, at der foretages undersøgelser for at udelukke underliggende ætiologi.
English: Animal studies have shown no evidence of teratogenicity but embryolethality was seen in both rat and rabbit studies (see section 5.3).
Danish: Dyrestudier har ikke påvist teratogenicitet, men embryonaldød er set i studier med både rotter og kaniner (se pkt.
English: What you need to know before you take Xyrem
Danish: Det skal De vide, før De begynder at tage Xyrem
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
English: The dose of sodium oxybate therefore does not require adjustment when given concomitantly with proton pump inhibitors.
Danish: Dosis af natriumoxybat kræver derfor ingen justering, når det gives sammen med proton-pumpe-hæmmere.
English: Trial 1 enrolled 246 patients with narcolepsy and incorporated a 1 week up-titration period.
Danish: Studie 1 inkluderede 246 patienter med narkolepsi og omfattede en uges optitreringsfase.
English: Patients were randomised to continued treatment with sodium oxybate at their stable dose or to placebo.
Danish: Patienterne randomiseredes til fortsat behandling med natriumoxybat i deres fastsatte doser eller til placebo.
English: Sodium oxybate has major influence on the ability to drive and use machines.
Danish: Natriumoxybat påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Vascular disorders Common: hypertension
Danish: Vaskulære sygdomme Almindelig: hypertension
English: Patients with a previous history of a depressive illness and/or suicide attempt should be monitored especially carefully for the emergence of depressive symptoms while taking sodium oxybate.
Danish: Patienter med tidligere depressiv sygdom og/eller suicidalforsøg bør monitoreres særligt omhyggeligt med hensyn til udvikling af depressive symptomer under behandling med natriumoxybat.
English: If you have the impression that the effect of Xyrem is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis De mener, at virkningen af Xyrem er for kraftig eller for svag, bør De tale med Deres læge eller henvende Dem på apoteket herom.
English: Ear and labyrinth disorders Common: vertigo Not known tinnitus
Danish: Øre og labyrint Almindelig: vertigo Ikke kendt: tinnitus
English: Metabolism and nutrition disorders Common: anorexia, decreased appetite Not known: Dehydration, increased appetite
Danish: Metabolisme og ernæring Almindelig: anoreksi, nedsat appetit Ikke kendt: dehydrering, øget appetit
English: Take doses within 24 hours after preparation.
Danish: Indtag doserne inden for 24 timer efter klargøringen.
English: The average peak plasma concentrations (1st and 2nd peak) following administration of a 9 g daily dose divided into two equivalent doses given four hours apart were 78 and 142 µg/mL, respectively.
Danish: Gennemsnitlige, maksimale plasmakoncentrationer (1. og 2. maksimum) efter administration af en daglig dosis på 9 g fordelt på to lige store doser givet med 4 timers mellemrum var henholdsvis 78 og 142 g/ml.
English: Xyrem contains sodium
Danish: Xyrem indeholder natrium
English: Place the caps provided on the dosing cups and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position (See Figure 4).
Danish: Sæt de medfølgende låg på doseringsbægrene, og drej hvert låg med uret (mod højre), til det klikker og låser i den børnesikre stilling (se figur 4).
English: Just before going to sleep, place your second dose near your bed.
Danish: 6 Lige før de går i seng anbringes den anden dosis i nærheden af sengen.
English: In some patients, cataplexy may return at a higher frequency on cessation of sodium oxybate therapy, however this may be due to the normal variability of the disease.
Danish: Hos nogle patienter kan katapleksi vende tilbage med en hyppigere frekvens, når natriumoxybat behandling ophører, men dette kan være på grund af den naturlige variabilitet af sygdommen.
English: In a rat carcinogenicity study with oxybate no compound-related tumours were identified.
Danish: I et karcinogenicitetsstudie med rotter med oxybat identificeredes ingen substansrelaterede tumorer.
English: An alternate pathway of biotransformation involves -oxidation via 3,4-dihydroxybutyrate to Acetyl CoA, which also enters the citric acid cycle to result in the formation of carbon dioxide and water.
Danish: En alternativ biotransformationsvej involverer -oxidation via 3,4-dihydroxybutyrat til Acetyl CoA, som derefter indgår i citronsyrecyklus, hvilket resulterer i dannelsen af kuldioxid og vand.
English: Animal studies indicate that metabolism is the major elimination pathway for sodium oxybate, producing carbon dioxide and water via the tricarboxylic acid (Krebs) cycle and secondarily by oxidation.
Danish: Dyrestudier tyder på, at metabolisme er den mest betydningsfulde udskillelsesvej for natriumoxybat ved produktion af kuldioxid og vand via Krebs' cyklus og sekundært ved -oxidation.
English: The dose of 9 g/day should not be exceeded due to the possible occurrence of severe symptoms at doses of 18 g/day or above (see section 4.4).
Danish: Den daglige dosis på 9 g bør ikke overskrides på grund af muligheden for svære symptomer ved doser på 18 g eller mere/dag (se pkt.
English: Prior to treatment physicians should evaluate patients for a history of or susceptibility to drug abuse.
Danish: Før behandlingen bør lægen evaluere patienter med tidligere stofmisbrug eller disposition for udvikling af stofmisbrug.
English: Pharmacokinetics is nonlinear with the area under the plasma concentration curve (AUC) versus time curve increasing 3.8-fold as dose is doubled from 4.5 g to 9 g. The pharmacokinetics is not altered with repeat dosing.
Danish: Farmakokinetikken er ikke-lineær med øgning af arealet under plasmakoncentrationskurven (AUC) vs. tidskurven på 3,8 gange, når dosis fordobles fra 4,5 g til 9 g. Farmakokinetikken ændres ikke med gentagne doser.
English: Treatment of narcolepsy with cataplexy in adult patients.
Danish: Behandling af narkolepsi med katapleksi hos voksne patienter.
English: The precise mechanism by which sodium oxybate produces an effect is unknown, however sodium oxybate is thought to act by promoting slow (delta) wave sleep and consolidating night-time sleep.
Danish: Den præcise mekanisme for natriumoxybats effekt er ukendt, men det antages, at natriumoxybat virker ved at promovere slow (delta) wave-søvn og konsolidere nattesøvnen.
English: The most serious adverse reactions are suicidal attempt, psychosis, respiratory depression and convulsion.
Danish: De mest alvorlige bivirkninger er suicidalforsøg, psykose, respirationsdepression og kramper.
English: Xyrem will affect you if you drive or operate tools or machines.
Danish: Xyrem påvirker evnen til at køre bil og arbejde med værktøj eller maskiner.
English: Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes (see section 5.2).
Danish: In vitro-studier med poolede, humane levermikrosomer indikerer, at natriumoxybat ikke signifikant hæmmer aktiviteten af de humane isoenzymer (se pkt.
English: Patients with succinic semialdehyde dehydrogenase deficiency.
Danish: Patienter med succinylsemialdehyddehydrogenasemangel.
English: Empty the medicine from the syringe into one of the dosing cups provided by pushing on the plunger (See Figure 3).
Danish: Tøm lægemidlet fra sprøjten ned i et af de medfølgende doseringsbægre ved at trykke på stemplet (se figur 3).
English: Because the kidney does not have a significant role in the excretion of sodium oxybate, no pharmacokinetic study in patients with renal dysfunction has been conducted; no effect of renal function on sodium oxybate pharmacokinetics would be expected.
Danish: Fordi nyrerne ikke har en signifikant rolle i udskillelsen af natriumoxybat, er der ikke foretaget farmakokinetiske studier med patienter med nedsat nyrefunktion; ingen effekt af nyrefunktionen på natriumoxybats farmakokinetik er forventelig.
English: There is no clinical data available on the effect of sodium oxybate on fertility.
Danish: Der foreligger ingen kliniske data vedrørende natriumoxybats virkning på fertilitet.
English: Since sodium oxybate is metabolised by GHB dehydrogenase there is a potential risk of an interaction with medicinal products that stimulate or inhibit this enzyme (e.g. valproate, phenytoin or ethosuximide) (see section 4.4).
Danish: Da natriumoxybat metaboliseres af GHB-dehydrogenase, er der en potentiel risiko for interaktion med lægemidler, som stimulerer eller hæmmer dette enzym (f.eks. valproat, phenytoin og ethosuximid) (se pkt.
English: Trial 4 enrolled 55 narcoleptic patients who had been taking open-label sodium oxybate for 7 to 44 months.
Danish: Studie 4 involverede 55 narkolepsipatienter, som ikke-blindet havde taget natriumoxybat i 7 til 44 måneder.
English: 180 mL solution in an amber oval 240 mL PET bottle which is delivered with a plastic/foil seal and closed with a child resistant closure composed of HDPE/polypropylene with a pulpboard inner liner.
Danish: 180 ml opløsning i en brun, oval 240 ml PET-flaske, som leveres med en plastik/folieforsegling og er lukket med en børnesikret lukning af HDPE/polypropylen med et indlæg af træpap.
English: Additionally, randomised, double-blind, placebo-controlled, crossover drug-drug interaction studies with ibuprofen, diclofenac and valproate were performed in healthy subjects and are summarised in section 4.5.
Danish: Derudover blev der udført randomiserede, dobbeltblinde, placebokontrollerede, crossover lægemiddelinteraktionsstudier med ibuprofen, diclofenac og valproat med raske personer, og disse er opsummeret i pkt.
English: Co-administration of sodium oxybate and diclofenac in healthy volunteers reduced the attention deficit caused by the administration of Xyrem alone as measured by psychometric tests.
Danish: Samtidig administration af natriumoxybat og diclofenac hos raske frivillige reducerede den nedsatte opmærksomhed forårsaget af administration af natriumoxybat alene målt ved psykometriske tests.
English: You may need to set an alarm so you wake up to take your second dose no earlier than 2.5 hours and no later than 4 hours after your first dose.
Danish: Det kan være nødvendigt at stille vækkeuret, så De er sikker på at vågne, når De skal tage den anden dosis tidligst 2½ time og senest 4 timer efter første dosis.
English: Table 1 Summary of clinical trials performed using sodium oxybate for the treatment of narcolepsy
Danish: Tabel 1 Sammenfatning af kliniske studier ved anvendelse af natriumoxybat til behandling af narkolepsi
English: Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise.
Danish: Katapleksi er indtræden af pludselig muskelsvækkelse eller lammelse uden tab af bevidsthed, der opstår som følge af en pludselig følelsesmæssig reaktion såsom vrede, frygt, glæde, latter eller overraskelse.
English: • How to Take Xyrem brochure (to be given to the patient): to provide patients with information related to the use of Xyrem.
Danish: • Brochure omhandlende hvordan man skal tage Xyrem (skal udleveres til patienten): for at give patienter oplysninger om brugen af Xyrem.
English: Immune system disorders Uncommon: hypersensitivity
Danish: Immunsystemet Ikke almindelig: overfølsomhed
English: Tabulated summary of adverse reactions Undesirable effects are listed according to MedDRA System Organ Class.
Danish: Skematisk oversigt over bivirkninger Bivirkningerne er anført i henhold til MedDRA-systemorganklasser.
English: Trial 2 compared the effects of orally administered sodium oxybate, modafinil and sodium oxybate + modafinil, with placebo in the treatment of daytime sleepiness in narcolepsy.
Danish: Studie 2 sammenlignede effekten af oralt administreret natriumoxybat, modafinil og natriumoxybat + modafinil, med placebo til behandling af søvnighed i dagtimerne ved narkolepsi.
English: Because emesis may occur in the presence of impaired consciousness, appropriate posture (left lateral recumbent position) and protection of the airway by intubation may be warranted.
Danish: Da emese kan opstå i tilfælde af bevidsthedssløring, skal passende lejring (aflåst sideleje) og beskyttelse af luftvejene ved intubation sikres.
English: Sodium oxybate has been administered concomitantly with CNS stimulant agents in approximately 80% of patients in clinical studies in narcolepsy.
Danish: Natriumoxybat har været administreret sammen med CNS-stimulerende lægemidler hos ca. 80 % af patienterne i kliniske studier med narkolepsi.
English: 246 MWT/Sleep Architecture/ Cataplexy/Naps/FOSQ
Danish: MWT/Sleep Architechure/ Katapleksi/Naps/FOSQ
English: Limited data from pregnant patients during second and third trimester indicate no malformative or foeto/neonatal toxicity of sodium oxybate.
Danish: Begrænsede data fra anvendelse af natriumoxybat hos gravide kvinder i 2. og 3. trimester indikerer ingen misdannelser eller føtal/neonatal toksicitet af natriumoxybat.
English: Xyrem is a clear to slightly opalescent solution.
Danish: Xyrem er en klar til let opaliserende opløsning.
English: Your doctor may gradually increase your dose up to a maximum of 9 g/day given as two equally divided doses of 4.5 g/dose.
Danish: Deres læge kan gradvist forøge Deres dosis op til højst 9 g/dag givet som to lige store doser på 4,5 g/dosis.
English: Not known: dry mouth
Danish: Ikke kendt: mundtørhed
English: Neuropsychiatric events
Danish: Neuropsykiatriske forhold
English: The primary measures of efficacy were changes in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), and the change in the overall severity of the patient's narcolepsy symptoms as assessed by the investigator using the Clinical Global Impressions of Change (CGI-c) measure.
Danish: Epworth Sleepiness Scale (ESS), samt ændringen i den overordnede alvorlighed af patientens narkolepsisymptomer, vurderet af den ansvarlige læge for undersøgelsen ved brug af Clinical Global Impressions of Change (CGI-c)-målingen.
English: Next, insert the tip of the measuring syringe into the centre opening of the bottle and press down firmly (See Figure 1).
Danish: Sæt derefter spidsen af målesprøjten ind midt i flaskens åbning, og tryk hårdt nedad (se figur 1).
English: Xyrem is used to treat narcolepsy with cataplexy in adults.
Danish: Xyrem anvendes til at behandle narkolepsi med katapleksi hos voksne.
English: Talk to your doctor or pharmacist before taking Xyrem: - if you have breathing or lung problems (and especially if you are obese), because Xyrem has the potential to cause difficulty in breathing; - if you have or have previously had depressive illness; - if you have heart failure, hypertension (high blood pressure), liver or kidney problems as your dose may need to be adjusted; - if you have previously abused drugs; - if you suffer from epilepsy as the use of Xyrem is not recommended in this condition; - if you have porphyria (an uncommon metabolic disorder).
Danish: Kontakt lægen eller apotekspersonalet, før De tager Xyrem: - hvis De har vejrtræknings- eller lungeproblemer (og især hvis De er overvægtig), fordi Xyrem kan forårsage åndedrætsbesvær, - hvis De lider eller tidligere har lidt af depressiv sygdom, - hvis De har hjertesvigt, hypertension (forhøjet blodtryk), lever- eller nyreproblemer, idet det kan være nødvendigt at justere Deres dosis, - hvis De tidligere har haft et stofmisbrug, - hvis De lider af epilepsi, da brug af Xyrem ikke kan anbefales ved denne sygdom, - hvis De har porfyri (en sjælden stofskiftesygdom).
English: Very common: nausea (the frequency of nausea is higher in women than men) Common: vomiting, diarrhoea, abdominal pain upper, Uncommon: faecal incontinence
Danish: Meget almindelig: kvalme (hyppigheden af kvalme er højere hos kvinder end hos mænd) Almindelig: opkastning, diaré, smerter i øvre abdomen Ikke almindelig: fækal inkontinens
English: If concomitant use is warranted, patient response and tolerability should be monitored and dose adjustments made if required (see section 4.2).
Danish: Hvis der er behov for samtidig administration, bør patientrespons og tolerabilitet monitoreres og dosis om nødvendigt justeres (se pkt.
English: While you are taking Xyrem, if you experience bed wetting and incontinence (both urine and faeces), confusion, hallucinations, episodes of sleepwalking or abnormal thinking you should tell your doctor straight away.
Danish: Hvis De, mens De tager Xyrem, oplever sengevædning og inkontinens (både urin og afføring), forvirring, hallucinationer, episoder med at gå i søvne eller unormal tankevirksomhed, bør De straks kontakte Deres læge.
English: Administration of sodium oxybate immediately after a high fat meal resulted in delayed absorption (average Tmax increased from 0.75 hr to 2.0 hr) and a reduction in peak plasma level (Cmax) by a mean of 58 and of systemic exposure (AUC) by 37.
Danish: Administration af natriumoxybat umiddelbart efter et måltid med højt fedtindhold resulterede i forsinket absorption (gennemsnitlig Tmax steg fra 0,75 timer til 2,0 timer) og en reduktion i peak-plasmaniveau (Cmax) med gennemsnitligt 58  og systemisk tilgængelighed (AUC) med 37 .
English: Rebound effects and withdrawal syndrome
Danish: Rebound-effekt og abstinenssymptomer
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekensinddeling er bivirkningerne opført efter faldende sværhedsgrad.
English: The oral solution is clear to slightly opalescent.
Danish: Den orale opløsning er klar til let opaliserende.
English: Other medicines and Xyrem
Danish: Brug af anden medicin sammen med Xyrem
English: A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyses the conversion to succinic semialdehyde in the presence of -ketoglutarate.
Danish: Et andet mitochondrielt oxidoreduktase-enzym, en transhydrogenase, katalyserer også omdannelsen til succinylsemialdehyd i tilstedeværelse af ketoglutarat.