FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX04.
Danish: Farmakoterapeutisk klassifikation: Andre midler med virkning på centralnervesystemet, ATC-kode: N07XX04.
English: If any of these apply to you, tell your doctor before you take Xyrem.
Danish: Hvis noget af dette gælder for Dem, skal De kontakte Deres læge, før De begynder at tage Xyrem.
English: Injury, poisoning and procedural complications Common: fall
Danish: Traumer, forgiftninger og behandlingskomplikationer Almindelig: fald
English: Patients being treated with opioids or barbiturates.
Danish: Patienter i behandling med opioider eller barbiturater.
English: If the patient stops taking the medicinal product for more than 14 consecutive days, titration should be restarted from the lowest dose.
Danish: Hvis patienten ophører med at tage lægemidlet i mere end 14 dage i træk, bør titrering genoptages fra laveste dosis.
English: You may need to moderate your intake of salt.
Danish: Det kan være nødvendigt at nedsætte forbruget af salt.
English: In the clinical trial database, greater than 80 % of patients maintained concomitant stimulant use.
Danish: I den kliniske forsøgsdatabase fortsatte mere end 80 % af patienterne med samtidig anvendelse af stimulerende midler.
English: Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or that requires mental alertness for at least 6 hours after taking Xyrem.
Danish: Lad være med at køre bil, betjene tunge maskiner eller udføre nogen form for aktivitet, som er farlig, eller som kræver mental årvågenhed, i mindst 6 timer, efter De har taget Xyrem.
English: You should have received a Xyrem Information Pack from your physician, which includes a booklet on how to take the medicine, a Frequently Asked Questions patient information sheet and a patient alert card.
Danish: De skulle fra Deres læge have modtaget en Xyrem-informationspakke, som omfatter et hæfte med information om, hvordan De skal tage lægemidlet, patientinformation omhandlende Ofte Stillede Spørgsmål samt et patient-sikkerhedskort.
English: Therefore, episodes of sleepwalking should be fully evaluated and appropriate interventions considered.
Danish: Derfor skal episoder med søvngængeri evalueres grundigt, og passende foranstaltninger skal overvejes.
English: Sodium oxybate is rapidly and almost completely absorbed after oral administration; absorption is delayed and decreased by a high fat meal.
Danish: Natriumoxybat absorberes hurtigt og næsten fuldstændigt efter oral administration; absorptionen forsinkes og nedsættes ved indtagelse af måltider med højt fedtindhold.
English: In particular Xyrem should not be taken together with sleep inducing medicines and medicines that reduce central nervous system activity (the central nervous system is the part of the body related to the brain and spinal cord).
Danish: Xyrem bør navnlig ikke tages sammen med sovemedicin og medicin, som hæmmer aktiviteten i centralnervesystemet, (centralnervesystemet er den del af kroppen, som omfatter hjernen og rygmarven).
English: These are usually mild to moderate.
Danish: Bivirkningerne er sædvanligvis lette til moderate.
English: Xyrem works by consolidating night-time sleep, though its exact mechanism of action is unknown.
Danish: Xyrem virker ved at forbedre nattesøvnen, men den nøjagtige virkningsmekanisme er ikke kendt.
English: Primary Efficacy
Danish: Primær effekt
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.
English: The primary measure of efficacy was excessive daytime sleepiness as measured by objective response in MWT.
Danish: Den primære måling af virkning var udtalt søvnighed i dagtimerne, målt ved objektiv respons i MWT.
English: In patients with epilepsy, the safety and efficacy of sodium oxybate has not been established, therefore use is not recommended.
Danish: Hos patienter med epilepsi, er sikkerhed og virkning af natriumoxybat ikke blevet klarlagt; derfor kan brug heraf ikke anbefales.
English: NOTE: Medicine will not flow into the syringe unless you keep the bottle in its upright position (See Figure 2).
Danish: BEMÆRK: Der vil ikke strømme lægemiddel ind i sprøjten, medmindre flasken holdes i opret stilling (se figur 2).
English: Blurred vision has been reported.
Danish: Sløret syn har været rapporteret.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR MENNESKELIGT LÆSBARE DATA
English: Xyrem has the potential to induce respiratory depression
Danish: Xyrem har potentiale til at fremkalde respirationsdepression
English: Information about signs and symptoms associated with overdose with sodium oxybate is limited.
Danish: Information om tegn og symptomer forbundet med overdosering med natriumoxybat er begrænset.
English: The pharmacodynamic interaction with zolpidem has not been assessed.
Danish: Farmakodynamisk interaktion med zolpidem er ikke blevet vurderet.
English: Patients with porphyria
Danish: Patienter med porfyri
English: Sodium oxybate is a hydrophilic compound with an apparent volume of distribution averaging 190384 mL/kg.
Danish: Natriumoxybat er et hydrofilt stof med et tilsyneladende fordelingsvolumen på gennemsnitlig 190384 ml/kg.
English: When you wake up 2.5 to 4 hours later, remove the cap from the second dosing cup.
Danish: Når De vågner 2½ til 4 timer senere, fjernes låget fra det andet doseringsbæger.
English: Because food significantly reduces the bioavailability of sodium oxybate, patients should eat at least several (2-3) hours before taking the first dose of Xyrem at bedtime.
Danish: Da mad signifikant nedsætter biotilgængeligheden af Xyrem, bør patienterne spise senest flere (2-3) timer før indtagelse af den første dosis Xyrem ved sengetid.
English: Investigations Common: blood pressure increased, weight decreased
Danish: Undersøgelser Almindelig: blodtryksforhøjelse, vægttab
English: Then add about 60 ml of water to each dosing cup (60 mL is about 4 tablespoons).
Danish: Hæld derefter ca. 60 ml vand i hvert doseringsbæger (60 ml er ca. 4 spiseskefulde).
English: Perinatal mortality was increased and mean pup weight was decreased during the lactation period in high-dose F1 animals.
Danish: Perinatal mortalitet steg og gennemsnitsvægten for unger blev nedsat i amningsperioden hos F1-dyr ved høje doser.
English: In a limited number of patients greater than the age of 65 years the pharmacokinetics of sodium oxybate was not different compared to patients younger than 65 years of age.
Danish: Hos et begrænset antal patienter over 65 år var natriumoxybats farmakokinetik ikke forskellig sammenlignet med patienter under 65 år.
English: Sodium oxybate p <0.001
Danish: Natriumoxybat p <0,001
English: For at least 6 hours after taking sodium oxybate, patients must not undertake activities requiring complete mental alertness or motor co-ordination, such as operating machinery or driving.
Danish: I mindst 6 timer efter indtagelse af natriumoxybat må patienter ikke deltage i aktiviteter, som kræver fuld mental opmærksomhed eller motorisk koordination, såsom at betjene maskiner og køre bil.
English: Elimination half-life was significantly longer in Class C and Class A patients than in control subjects (mean t1/2 of 59 and 32 versus 22 minutes).
Danish: Eliminationshalveringstiden var signifikant længere i klasse C- og klasse A-patienter end i kontrolgruppen (mean t1/2 på 59 og 32 vs. 22 minutter).
English: Treatmentrelated clinical signs were mainly related to sedation, reduced food consumption and secondary changes in body weight, body weight gain and organ weights.
Danish: Behandlingsrelaterede kliniske tegn var hovedsagelig relateret til sedation, nedsat fødeindtagelse og sekundære forandringer i legemsvægt, vægtøgning og organvægt.
English: Placebo (56) Sodium Oxybate (55) Modafinil (63) Sodium Oxybate + Modafinil (57)
Danish: Placebo (56) Natriumoxybat (55) Modafinil (63) Natriumoxybat + Modafinil (57)
English: Special caution should be observed in patients with an underlying respiratory disorder.
Danish: Særlig forsigtighed bør udvises over for patienter med en underliggende respirationslidelse.
English: A possible additive effect of antidepressants and sodium oxybate cannot be excluded.
Danish: En mulig additiv effekt af antidepressiva og natriumoxybat kan ikke udelukkes.
English: While holding the bottle and syringe with one hand, draw up the prescribed dose with the other hand by pulling on the plunger.
Danish: Mens flasken og sprøjten holdes med den ene hånd, trækkes den foreskrevne dosis op med den anden hånd ved at trække i stemplet.
English: However, due to the rapid metabolism of sodium oxybate, these measures are not warranted.
Danish: På grund af den hurtige metabolisme af natriumoxybat kan disse tiltag imidlertid ikke betale sig.
English: Repeat this step for the second dosing cup.
Danish: Gentag dette for det andet doseringsbæger.
English: Once you open a bottle of Xyrem, any contents that you have not used with 40 days of opening should be disposed of.
Danish: Når De har åbnet en flaske Xyrem, skal det, der ikke er anvendt inden for 40 dage, kasseres.
English: Prepare both doses before bedtime.
Danish: Gør begge doser klar inden sengetid.
English: The safety and efficacy of sodium oxybate in children and adolescents aged 0-18 years has not been established.
Danish: Natriumoxybats sikkerhed og virkning hos børn og unge i alderen 0-18 år er ikke klarlagt.
English: Trial 3 enrolled 136 narcoleptic patients with moderate to severe cataplexy (median of 21 cataplexy attacks per week) at baseline.
Danish: Studie 3 involverede 136 narkolepsipatienter med moderat til alvorlig katapleksi (median på 21 katapleksianfald pr. uge) ved baseline.
English: Very common (may affect more than 1 in 10 people): Nausea, dizziness, headache
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter): Kvalme, svimmelhed, hovedpine.
English: There is a plastic covered foil seal on the top of the bottle, which must be removed before using the bottle for the first time.
Danish: Toppen af flasken er forseglet med plastikfolie, som skal fjernes, før flasken tages i brug første gang.
English: • Patient Alert Card (to be given to the patient): to remind patients, physicians and/or pharmacists of the important safety information related to the use of Xyrem.
Danish: • Patientsikkerhedskort (skal udleveres til patienten): for at minde patienterne, lægerne og/eller apotekspersonalet om den vigtige sikkerhedsinformation i forbindelse med brug af Xyrem.
English: Trial 2 EDS (MWT)
Danish: Studie 2 EDS (MWT)
English: Changes in sleep patterns have been observed in breastfed infants from exposed mothers.
Danish: Ændringer i søvnmønster er observeret hos ammede spædbørn fra eksponerede mødre.
English: The emergence of thought disorders including thoughts of committing violent acts (including harming others) and/or behavioural abnormalities when patients are treated with sodium oxybate requires careful and immediate evaluation.
Danish: Udvikling af tankeforstyrrelser, herunder tanker om at begå voldelige handlinger (herunder at skade andre) og/eller adfærdsmæssige abnormiteter, når patienter er i behandling med natriumoxybat, kræver omhyggelig og omgående evaluering.
English: Antidepressants have been used in the treatment of cataplexy.
Danish: Antidepressiva har været anvendt til behandling af katapleksi.
English: Remove the syringe from the centre opening of the bottle.
Danish: Fjern sprøjten fra flaskens åbning.
English: Selfadministration studies in rats, mice and monkeys have produced conflicting results, whereas tolerance to GHB as well as cross-tolerance to alcohol and baclofen has been clearly demonstrated in rodents.
Danish: Selvadministrationsstudier med rotter, mus og aber har vist modstridende resultater, mens tolerance over for GHB samt krydstolerance med alkohol og baclofen tydeligt er demonstreret hos gnavere.
English: Sodium oxybate and/or its metabolites are excreted into breast milk.
Danish: Natriumoxybat og/eller dets metabolitter udskilles i human mælk.
English: Malic acid for pH adjustment Sodium hydroxide for pH adjustment
Danish: Æblesyre til pH justering Natriumhydroxid til pH justering
English: Because of the higher risk of sleep apnoea, patients with a BMI ≥40 kg/m should be monitored closely when taking sodium oxybate.
Danish: På grund af øget risiko for søvnapnø bør patienter med et BMI ≥40 kg/m monitoreres nøje, mens de tager natriumoxybat.
English: While sitting in bed, drink all of the second dose right before lying down to continue sleeping.
Danish: Mens De sidder i sengen, drikkes hele den anden dosis, lige før De lægger Dem ned for at sove videre.
English: Sodium oxybate is the sodium salt of GHB.
Danish: Natriumoxybat er natriumsaltet af GHB.
English: There have been case reports of dependence after illicit use of GHB at frequent repeated doses (18 to 250 g/day) in excess of the therapeutic dose range.
Danish: Der har været rapporteret tilfælde af afhængighed efter ulovlig brug af GHB ved hyppigt gentagne doser (18 til 250 g/dag) ud over det terapeutiske dosisinterval.
English: If you stop taking Xyrem for more than 14 consecutive days you should consult your doctor as you should restart taking Xyrem at a reduced dose.
Danish: Hvis De holder op med at tage Xyrem i mere end 14 dage i træk, bør De kontakte Deres læge, da De skal genoptage behandlingen med Xyrem på en nedsat dosis.
English: If you are taking valproate together with Xyrem, the dose of Xyrem will be adapted by your doctor.
Danish: Hvis De tager valproat sammen med Xyrem, vil Deres læge tilpasse dosis af Xyrem.
English: If you stop taking Xyrem
Danish: Hvis De holder op med at tage Xyrem
English: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom.
Danish: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, Storbritannien
English: Xyrem 500 mg/mL (applies to carton only)
Danish: Xyrem 500 mg/ml (gælder kun karton)
English: The average time to peak plasma concentration (Tmax) ranged from 0.5 to 2 hours in eight pharmacokinetic studies.
Danish: Den gennemsnitlige tid til peakplasmakoncentrationer (Tmax) strakte sig fra 0,5 til 2 timer i otte farmakokinetiske studier.
English: Although gag reflex may be absent in deeply comatose patients, even unconscious patients may become combative to intubation, and rapid sequence induction (without the use of sedative) should be considered.
Danish: Selv om brækrefleksen kan forsvinde hos dybt komatøse patienter, kan selv bevidstløse patienter modarbejde intubation, og rapid sequence induction (uden brug af sedativa) bør overvejes.
English: It is recommended that both doses of Xyrem should be made up at the same time upon retiring to bed.
Danish: Det anbefales, at begge doser Xyrem klargøres samtidigt før sengetid.
English: In addition to the adverse reactions reported during clinical studies, adverse reactions have been reported in post-marketing experience.
Danish: Ud over de bivirkninger, der blev rapporteret i kliniske studier, er der også rapporteret bivirkninger efter markedsføring.
English: The primary efficacy measure in this trial was the frequency of cataplexy attacks.
Danish: Den primære måling af virkning i dette studie omfattede hyppigheden af katapleksianfald.
English: Patients should always observe the same timing of dosing in relation to meals.
Danish: Patienterne bør altid overholde samme tidsinterval mellem dosering og måltider.
English: There are reports of compromise in the rate and depth of respiration and of life-threatening respiratory depression, necessitating intubation and ventilation.
Danish: Der er rapporteret tilfælde med kompromitteret respirationsfrekvens og -dybde og tilfælde med livstruende respirationsdepression, som gjorde intubation og ventilation nødvendig.
English: Emesis (even with impaired consciousness), diaphoresis, headache, and impaired psychomotor skills may be observed.
Danish: Emesis (selv ved bevidsthedssløring), diaphorese, hovedpine, og hæmmede psykomotoriske færdigheder kan ses.
English: The emergence of depression when patients are treated with sodium oxybate requires careful and immediate evaluation.
Danish: Udvikling af depression, mens patienter er i behandling med natriumoxybat, kræver omhyggelig og omgående evaluering.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Endpoint Compared to Placebo
Danish: Slutværdi sammenlignet med placebo
English: • medicines that may be processed in a similar way by the body (e.g., valproate, phenytoin or ethosuximide which are used for the treatment of fits)
Danish: • medicin, som kroppen optager og bearbejder på samme måde (f.eks. valproat, phenytoin eller ethosuximid, som anvendes til behandling af kramper)
English: Sodium oxybate should not be used in combination with sedative hypnotics or other CNS depressants.
Danish: Natriumoxybat bør ikke anvendes i kombination med sedative hypnotika eller andre CNS-depressive lægemidler.
English: Repeat administration of sodium oxybate to rats (90 days and 26 weeks) and dogs (52 weeks) did not result in any significant findings in clinical chemistry and micro- and macro pathology.
Danish: Gentagen administration af natriumoxybat til rotter (90 dage og 26 uger) og til hunde (52 uger) resulterede ikke i nogen signifikante fund i den kliniske kemi og mikro- og makropatologi.
English: Following oral administration, the plasma levels of sodium oxybate increase more than proportionally with increasing dose.
Danish: Efter oral administration øges plasmaniveauer af natriumoxybat mere end proportionalt for hver dosisøgning.
English: Sodium oxybate, which is as the sodium salt of GHB, is a CNS depressant active substance with wellknown abuse potential.
Danish: Natriumoxybat, som er et natriumsalt af GHB, er et CNS-depressivt aktivt stof med velkendt misbrugspotentiale.
English: If you forget to take Xyrem
Danish: Hvis De har glemt at tage Xyrem
English: Very common: dizziness, headache
Danish: Meget almindelig: svimmelhed, hovedpine
English: Given the possibility of increasing the risk of respiratory depression, the concomitant use of benzodiazepines and sodium oxybate should be avoided.
Danish: På grund af muligheden for øget risiko for respirationsdepression bør samtidig brug af benzodiazepiner og natriumoxybat undgås.
English: Succinic acid enters the Krebs cycle where it is metabolised to carbon dioxide and water.
Danish: Succinylsyre indgår i Krebs' cyklus, hvor det metaboliseres til kuldioxid og vand.
English: Sodium oxybate is considered to be unsafe in patients with porphyria because it has been shown to be porphyrogenic in animals or in vitro systems.
Danish: Natriumoxybat anses ikke for sikkert til patienter med porfyri, da det har vist sig at føre til porfyri hos dyr og i in vitro-systemer.
English: During the 8 week double-blind period, patients took modafinil at their established dose or placebo equivalent.
Danish: I den 8 ugers dobbeltblinde periode tog patienterne enten modafinil som fast dosis eller tilsvarende placebo.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: The resulting pharmacodynamic effects, including increased impairment in cognitive function and sleepiness, were greater with co-administration than those observed with either drug alone.
Danish: De farmakodynamiske virkninger, herunder øget forringelse af den kognitive funktion og søvnighed, var større ved samtidig administration end ved administration af stofferne alene.
English: Events of hypernatremia with metabolic alkalosis have been reported in the context of concomitant use of NaCl infusion.
Danish: Der er rapporteret tilfælde af hypernatriæmi med metabolisk alkalose i forbindelse med samtidig brug af NaCl-infusion.
English: The medicinal product should be used within 40 days after the first opening.
Danish: Lægemidlet bør anvendes inden 40 dage efter anbrud.
English: After a single oral dose of 25 mg/kg, AUC values were double in cirrhotic patients, with apparent oral clearance reduced from 9.1 in healthy adults to 4.5 and 4.1 mL/min/kg in Class A (without ascites) and Class C (with ascites) patients, respectively.
Danish: Efter en enkel oral dosis på 25 mg/kg fordobles AUC-værdier hos cirrotiske patienter med en tilsyneladende oral clearance-reduktion fra 9,1 hos raske voksne til 4,5 og 4,1 ml/min/kg henholdsvis i klasse A (uden ascites) og klasse C (med ascites).
English: • Healthcare Professional Checklist (i.e. treatment initiation forms): to remind physicians to check the contraindications, warnings, and precautions in the SmPC and specifically highlighting that Xyrem can cause CNS and respiratory depression, that alcohol may result in the potentiation of CNS depression and that Xyrem has an abuse potential.
Danish: • Tjekliste til sundhedspersonalet (dvs. formularer til initiering af behandlingen): for at minde læger om at kontrollere kontraindikationer, advarsler og forsigtighedsregler i produktresumeét og for specifikt at fremhæve, at Xyrem kan forårsage CNS-depression og respirationsdepression, at alkohol kan potensere CNS-depression, og at Xyrem har et misbrugspotentiale.
English: If you have liver problems, the starting dose should be halved.
Danish: Hvis De har leverproblemer, bør begyndelsesdosis af Xyrem halveres.
English: Trial 1 EDS (ESS); CGIc
Danish: Studie 1 EDS (ESS); CGIc
English: • If you are taking valproate, your daily dose of Xyrem will need to be adjusted (see section 3) as it may lead to interactions
Danish: • hvis De tager valproat, er det nødvendigt at justere Deres daglige dosis af Xyrem (se afsnit 3), da valproat kan påvirke den måde, hvorpå Xyrem virker.
English: GHB had no effect on mating, general fertility or sperm parameters and did not produce embryofoetal toxicity in rats exposed to up 1000 mg/kg/day GHB (1.64 times the human exposure calculated in nonpregnant animals).
Danish: GHB havde ingen effekt på parring, almen fertilitet eller spermparametre og forårsagede ikke embryoføtal toksicitet hos rotter, som blev eksponeret for op til 1.000 mg/kg/dag GHB (1,64 gange den humane eksponering udregnet i ikke-gravide dyr).
English: Whilst there is no clear evidence of emergence of dependence in patients taking sodium oxybate at therapeutic doses, this possibility cannot be excluded.
Danish: Selv om der ikke er klar evidens for, at patienter i behandling med natriumoxybat i terapeutiske doser skulle kunne blive afhængige, kan dette ikke udelukkes.
English: Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes: CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 µg/mL).
Danish: In vitro studier med poolede, humane levermicrosomer indikerer, at natriumoxybat ikke signifikant hæmmer aktiviteten af de humane isoenzymer: CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, eller CYP3A op til en koncentration på 3 mM (378 g/ml).