FrancophonIA/ELRC3.0 huggingface dataset:
English: > 45 min improvement in both nighttime and daytime sleep (%)(5)
Danish: > 45 minutters bedring i både nattesøvn og søvn om dagen (%)(5)
English: SET Study Clinical response (Entrainment + N24CRS
Danish: Klinisk respons (regulering + N24CRS
English: - This medicine has been prescribed for you only.
Danish: − Lægen har ordineret dette lægemiddel til dig personligt.
English: SET and RESET assessed entrainment of the master body clock as measured by aMT6s and cortisol.
Danish: SET og RESET vurderede reguleringen af kroppens biologiske ur, målt ved aMT6s og kortisol.
English: Tasimelteon exposure was increased by approximately 50% when co-administered with ketoconazole 400 mg (after 5 days of ketoconazole 400 mg per day).
Danish: Eksponeringen for tasimelteon blev øget med ca. 50 % ved koadministration med ketoconazol 400 mg (efter fem dage med ketoconazol 400 mg dagligt).
English: The pharmacokinetics of tasimelteon and its metabolites did not change with repeated daily dosing.
Danish: Farmakokinetikken af tasimelteon og dets metabolitter ændredes ikke ved gentagen daglig dosering.
English: In pregnant rats administered tasimelteon during the period of organogenesis, there were no effects on embryofoetal development.
Danish: Indgift af tasimelteon hos drægtige rotter i organogeneseperioden medførte ingen virkning af den embryoføtale udvikling.
English: Smoking (moderate CYP1A2 inducer)
Danish: Rygning (moderat CYP1A2-induktor)
English: Nightmare
Danish: Mareridt
English: The most common adverse reactions (>3%) during clinical trials were headache (10.4%), somnolence (8.6%), nausea (4.0%), and dizziness (3.1%).
Danish: De hyppigste bivirkninger (>3 %) i de kliniske forsøg var hovedpine (10,4 %), somnolens (8,6 %), kvalme (4,0 %) og svimmelhed (3,1 %).
English: The peak concentration (Tmax) of tasimelteon occurred approximately 0.5 hours after fasted oral administration.
Danish: Maksimal-koncentrationen (Tmax) af tasimelteon indtrådte ca. 0,5 timer efter fastende oral indgift.
English: Due to the overall inter-subject variability of tasimelteon, this increase is not clinically meaningful and dose adjustment is not recommended.
Danish: På grund af den generelle interindividuelle variabilitet af tasimelteon er denne forskel ikke klinisk betydningsfuld, og der anbefales ingen dosisjustering.
English: If you eat a high-fat meal close to the time you would normally take the medicine, it is best to wait 2 hours before taking HETLIOZ.
Danish: Hvis du spiser et fedtrigt måltid omkring det tidspunkt, hvor du plejer at tage lægemidlet, er det bedst at vente to timer med at tage HETLIOZ.
English: Tasimelteon may cause somnolence.
Danish: Tasimelteon kan bevirke somnolens.
English: If you accidentally take more HETLIOZ than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Danish: Hvis du er kommet til at tage mere HETLIOZ end lægen har anbefalet, skal du straks kontakte lægen eller nærmeste akutmodtagelse for at få rådgivning.
English: Metabolism of tasimelteon consists primarily of oxidation at multiple sites and oxidative dealkylation resulting in opening of the dihydrofuran ring followed by further oxidation to give a carboxylic acid.
Danish: Tasimelteon metaboliseres hovedsagelig ved oxidation flere steder i molekylet og oxidativ dealkylering, der medfører åbning af dihydrofuran-ringen efterfulgt af yderligere oxidation, der resulterer i en carboxylsyre.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tasimelteon therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med HETLIOZ skal ophøre/undlades, idet der tages højde for fordelene ved amning for barnet og den terapeutiske fordel for moderen.
English: When administered with a high-fat meal, the Cmax of tasimelteon was 44% lower than when administered in a fasted state, and the median Tmax was delayed by approximately 1.75 hours.
Danish: Ved indgift sammen med et fedtrigt måltid var Cmax af tasimelteon 44 % lavere end ved fastende indgift, og den mediane Tmax blev forsinket med ca. 1,75 timer.
English: It aligns body rhythms with the usual 24-hour day and night cycle and so improve sleep patterns.
Danish: Det retter kroppens rytmer ind efter den normale 24-timers dag-og-nat cyklus og giver derved et bedre søvnmønster.
English: RESET was a randomised withdrawal trial in 20 patients with Non-24 (median age 55 years) that was designed to evaluate the maintenance of efficacy of tasimelteon after 12-weeks.
Danish: RESET var et randomiseret seponeringsforsøg hos 20 patienter med Non-24 (medianalder 55 år) til vurdering af opretholdelsen af virkningen af tasimelteon efter 12 uger.
English: Patients in whom the calculated time of peak melatonin level (melatonin acrophase) occurred at approximately the same time of day (in contrast to the expected daily delay) during the run-in phase were randomised to receive placebo or continue daily treatment with tasimelteon 20 mg for 8 weeks.
Danish: De patienter, hos hvem den maksimale melatoninkoncentration (melatonin-akrofase) blev beregnet til at indtræde på omtrent samme klokkeslæt (modsat den forventede daglige forsinkelse) i indkøringsfasen, blev randomiseret til placebo eller fortsat daglig behandling med tasimelteon 20 mg i 8 uger.
English: Adverse reactions leading to discontinuation occurred in 2.3% of tasimelteon-treated patients.
Danish: Bivirkninger, der medførte seponering, forekom hos 2,3 % af de patienter, der blev behandlet med tasimelteon.
English: Tasimelteon is a circadian regulator that resets the master body clock in the suprachiasmatic nucleus (SCN).
Danish: Tasimelteon er en cirkadiansk regulator, der styrer det biologiske ur i nucleus suprachiasmaticus.
English: During SET, patient diaries were recorded for an average of 88 days during screening and 133 days during randomisation.
Danish: I SET blev patientdagbøgerne gennemsnitligt ført i 88 døgn under screeningen og 133 døgn under randomiseringen.
English: - To open the bottle, push the cap down and turn counter-clockwise.
Danish: - For at åbne flasken skal du trykke låget ned og skrue modsat urretningen.
English: The effectiveness of tasimelteon to improve clinical global functioning was evaluated in SET.
Danish: I SET vurderedes effektiviteten af tasimelteon til bedring af den globale kliniske funktion.
English: Propylene glycol Sodium hydroxide Povidone K17
Danish: Propylenglycol Natriumhydroxid Povidon K17
English: Each bottle also contains a 1.5-g silica gel desiccant canister and polyester dunnage.
Danish: Hver flaske indeholder en cylinder med 1,5 g silicagel tørremiddel og polyesterfyld.
English: - The shell of the capsule consists of gelatin, titanium dioxide, Brilliant Blue FCF, Erythrosine, and Orange Yellow S (E110).
Danish: − Kapslens skal består af gelatine, titaniumdioxid, Brilliant Blue FCF, erytrocin og Orange Yellow S (E110).
English: In a study of 28 healthy volunteers, a single dose of ethanol (0.6 g/kg for women and 0.7 g/kg for men) was co-administered with a 20 mg dose of tasimelteon.
Danish: I en undersøgelse med 28 raske forsøgspersoner blev en enkeltdosis af ethanol (0,6 g/kg for kvinder og 0,7 g/kg for mænd) koadministreret med en dosis på 20 mg tasimelteon.
English: The mean overall exposure of tasimelteon was approximately 1.6-fold greater in female than in male subjects.
Danish: Den gennemsnitlige samlede eksponering for tasimelteon var ca. 1,6 gange højere for kvinder end for mænd.
English: Common: may affect up to 1 in 10 people - change in sleeping pattern - difficulty in sleeping - dizziness - dry mouth - tiredness - indigestion - feeling sick in the stomach - blood tests which show changes in the way the liver is working (alanine aminotransferase) - unusual dreams - sleepiness
Danish: Almindelig: forekommer hos op til 1 ud af 10 personer) - ændret søvnmønster - søvnbesvær - svimmelhed - mundtørhed - træthed - fordøjelsesbesvær - kvalme - ændring i blodprøver, der viser hvordan leveren fungerer (alaninaminotransferase) - usædvanlige drømme - søvnighed
English: During RESET, patient diaries were recorded for an average of 57 days during the run-in phase and 59 days during the randomised-withdrawal phase.
Danish: I RESET blev patientdagbøgerne i gennemsnit ført i 57 døgn i indkøringsfasen og 59 døgn i den randomiserede seponeringsfase.
English: Non-24 Scale of Clinical Response
Danish: Skala for klinisk respons ved Non-24
English: There was no increase in tumours at the lowest dose tested in rats, which is approximately 10 times the recommended human doseon a mg/m2 basis.
Danish: Der var ikke øget forekomst af tumorer hos rotter ved den laveste testede dosis, som er ca. 10 gange den anbefalede humane dosis på mg/m2-basis.
English: - Store in the original container and keep tightly closed in order to protect from moisture and light.
Danish: - Opbevares i den originale emballage, som skal holdes tæt tillukket for at beskytte mod fugt og lys.
English: The following are adverse reactions that were reported in tasimelteon-treated adult patients, derived from patient trials in 1772 patients treated with tasimelteon.
Danish: Følgende bivirkninger blev indberettet hos voksne patienter ved behandling med tasimelteon og er udledt af kliniske forsøg med 1 772 patienter, der blev behandlet med tasimelteon.
English: The efficacy of tasimelteon may be reduced in patients with concomitant administration of beta adrenergic receptor antagonists.
Danish: Betablokkere Virkningen af tasimelteon kan være nedsat ved koadministration af beta-adrenerge receptorantagonister.
English: In sighted people, the change in light levels between day and night helps to synchronise internal body rhythms, including feeling sleepy at night and being active during the day.
Danish: Hos seende personer bevirker ændringen fra dagslys til nat, at kroppens indre døgnrytme bliver synkroniseret, så man er søvnig om natten og aktiv om dagen.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin, har gjort det for nylig eller påtænker at gøre det.
English: Dysguesia
Danish: Dysgeusi
English: Excipient(s) with known effect: Each hard capsule contains 183.25 mg of lactose (as anhydrous) and 0.03 mg of Orange Yellow S (E110).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver hård kapsel indeholder 183,25 mg lactose (som vandfri) og 0,03 mg Orange Yellow S (E110).
English: Elderly No dose adjustment is recommended for individuals older than 65 years of age (see section 5.2).
Danish: Ældre Der behøves ingen dosisjustering for personer over 65 år (se pkt.
English: This is deemed even more important for strong CYP1A2 inhibitors also inhibiting other enzymes involved in the clearance of HETLIOZ (e.g. fluvoxamine and ciprofloxacin).
Danish: Dette menes at være endnu mere relevant for stærke CYP1A2-hæmmere, der også hæmmer andre enzymer, som er involveret i clearance af HETLIOZ (f.eks. fluvoxamin og ciprofloxacin).
English: The master body clock regulates the circadian rhythms of hormones including melatonin and cortisol and aligns/synchronises the physiological processes of the sleep-wake cycle and metabolic and cardiovascular homeostasis.
Danish: Det biologiske ur regulerer døgnrytmen af hormoner, herunder melatonin og kortisol, og synkroniserer de fysiologiske processer søvn-vågencyklus og metabolisk og kardiovaskulær homøostase.
English: Tell your doctor if you have an allergy to Orange Yellow S (E110).
Danish: Sig det til lægen, hvis du er allergisk over for Orange Yellow S (E110).
English: What you need to know before you take HETLIOZ 3.
Danish: Det skal du vide, før du begynder at tage HETLIOZ 3.
English: High density polyethylene (HDPE) bottle containing 30 hard capsules with polypropylene child-resistant closures containing polypropylene resin induction seals.
Danish: HD-polyethylen (HDPE) flaske indeholdende 30 hårde kapsler med børnesikret låg af polypropylen og induktionsforsegling med polypropylenharpiks.
English: Smokers (smoking is a moderate CYP1A2 inducer) Tasimelteon exposure decreased by approximately 40% in smokers, compared to non-smokers (see section
Danish: Rygere (rygning er en moderat CYP1A2-induktor) Eksponeringen for tasimelteon var ca. 40 % lavere hos rygere end hos ikke-rygere (jf. pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Xtandi findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Somnolence, dizziness
Danish: Somnolens, svimmelhed
English: Treatment with tasimelteon resulted in a significant improvement, compared with placebo, for all of these endpoints in SET and RESET (see Table 3).
Danish: Tasimelteon forbedrede væsentligt alle disse endepunkter i forhold til placebo i SET og RESET (jf.
English: HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Danish: HETLIOZ er indiceret til behandling af Non-24-Hour Sleep-Wake Disorder (Non-24) hos totalt blinde voksne.
English: While haemodialysis was effective at clearing tasimelteon and the majority of its major metabolites in patients with renal impairment, it is not known if hemodialysis will effectively reduce exposure in the case of overdose.
Danish: Hæmodialyse var effektiv til at fjerne tasimelteon og størstedelen af dets hovedmetabolitter hos patienter med nyrefunktionsnedsættelse, men det vides ikke, om hæmodialyse effektivt nedsætter eksponeringen ved overdosis.
English: How to take HETLIOZ 4.
Danish: Sådan skal du tage HETLIOZ 4.
English: It is unknown whether tasimelteon/metabolites are excreted in human milk.
Danish: Det vides ikke, om tasimelteon eller dets metabolitter udskilles i modermælk.
English: - The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone K17 and titanium dioxide.
Danish: − Den hvide trykfarve indeholder shellac, propylenglycol, natriumhydroxid, povidon K17 og titaniumdioxid.
English: In elderly subjects, tasimelteon exposure increased by approximately two-fold compared to non-elderly adults.
Danish: Hos ældre var eksponeringen for tasimelteon ca. dobbelt så høj som hos ikke-ældre voksne.
English: - If HETLIOZ is not taken every night, the body rhythms will lose alignment with the usual 24-hour day and night cycle again.
Danish: - Hvis du ikke tager HETLIOZ hver aften, vil din krop igen komme ud af trit med den normale 24timers døgnrytme.
English: The observed mean elimination half-life for tasimelteon is 1.3 ± 0.4 hours.
Danish: Plasmaeliminationshalveringstiden af tasimelteon er 1,3 ± 0,4 timer.
English: Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
Danish: Følgende betegnelser og hyppigheder finder anvendelse efter MedDRA systemorganklasse: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1 000 til ≤1/100); sjælden (≥1/10 000 til ≤1/1 000); meget sjælden (≤1/10 000).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 30-COUNT BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 30-STYKS FLASKE
English: After taking HETLIOZ, patients should limit their activity to preparing for going to bed.
Danish: Efter at have taget HETLIOZ bør patienten ikke foretage sig andet end at gøre sig klar til at gå i seng.
English: Assessment
Danish: Vurdering
English: Tasimelteon exposure decreased by approximately 40% in smokers compared to non-smokers (see section 5.2).
Danish: Eksponeringen for tasimelteon var ca. 40 % lavere hos rygere end hos ikke-rygere (se pkt.
English: Aspartate aminotransferase increased, gamma-glutamyl transferase increased
Danish: Aspartataminotransferase forhøjet, gammaglutamyltransferase forhøjet
English: The effectiveness of tasimelteon in the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) was established in two randomised, double-masked, placebo-controlled, multicentre, parallel-group studies (SET and RESET) in totally blind patients with Non-24.
Danish: Effektiviteten af tasimelteon til behandling af Non-24-Hour Sleep-Wake Disorder (Non-24) blev fastslået i SET og RESET, der var to randomiserede, dobbeltblindede, placebokontrollerede multicenterforsøg med parallelle grupper hos totalt blinde patienter med Non-24.
English: Each hard capsule contains 20 mg tasimelteon.
Danish: Hver hård kapsel indeholder 20 mg tasimelteon.
English: HETLIOZ contains the active substance tasimelteon.
Danish: HETLIOZ indeholder det aktive stof tasimelteon.
English: The no effect dose (50 mg/kg/day) is approximately 25 times the RHD on a mg/m2 basis.
Danish: Dosis uden effekt (50 mg/kg/dag) er ca. 25 gange den anbefalede dosis til mennesker på mg/m2-basis.
English: In SET, 84 patients with Non-24 (median age 54 years) were randomised to receive tasimelteon 20 mg or placebo, one hour prior to bedtime, at the same time every night for up to 6 months.
Danish: SET omfattede 84 patienter med Non-24 (medianalder 54 år), som blev randomiseret til tasimelteon 20 mg eller placebo, indgivet en time før sengetid på samme klokkeslæt hver aften i indtil seks måneder.
English: Reproductive and developmental toxicity studies showed that oestrous cycles were prolonged in rats treated with high doses of tasimelteon, with no effect on mating performance or male fertility, and only a marginal effect on female fertility.
Danish: Undersøgelser af reproduktionstoksicitet og udviklingstoksicitet viste forlænget østruscyklus hos rotter ved høje doser tasimelteon, men uden virkning på parringsevnen hos hanrotter og med kun marginal virkning på fertiliteten af hunrotter.
English: Because of individual differences in each person's body rhythms, it could take weeks or up to 3 months for an improvement in symptoms to be noticed.
Danish: Der er forskelle i kropsrytme hos forskellige personer, og det kan således tage flere uger eller op til 3 måneder, før der mærkes bedring i symptomerne.
English: Potential for other medicinal products to affect tasimelteon CYP1A2 and CYP3A4 are enzymes identified to play a role in the metabolism of tasimelteon, with a minor role for CYP2C9/C19.
Danish: Andre lægemidlers potentiale for at påvirke virkningen af tasimelteon CYP1A2 og CYP3A4 er enzymer, der er påvist at spille en rolle i metaboliseringen af tasimelteon, idet CYP2C9/C19 spiller en mindre rolle.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: I de prækliniske studier blev der kun iagttaget virkninger ved doser, der anses for at overstige den maksimale humane eksponering i væsentlig grad.
English: CYP1A2 (35.4%) and CYP3A4 (24.3%) are the major enzymes identified to play a role in the metabolism of tasimelteon.
Danish: CYP1A2 (35,4%) og CYP3A4 (24,3%) er enzymer, der er påvist at spille en rolle i metaboliseringen af tasimelteon.
English: RESET demonstrated the maintenance of entrainment with tasimelteon treatment compared to placebo withdrawal (aMT6s: 90% vs. 20% and cortisol: 80% vs. 20%).
Danish: RESET viste, at døgnrytmereguleringen blev opretholdt ved seponering af tasimelteon sammenholdt med seponering af placebo (aMT6s: 90 % sammenholdt med 20 %, og kortisol: 80 % sammenholdt med 20 %).
English: HETLIOZ contains Orange Yellow S (E110) which may cause allergic reactions.
Danish: HETLIOZ indeholder Orange Yellow S (E110), som kan forårsage allergiske reaktioner.
English: The recommended dosage of HETLIOZ is 20 mg (1 capsule) per day taken one hour before bedtime, at the same time every night.
Danish: Den anbefalede dosis af HETLIOZ er 20 mg (1 kapsel) dagligt, der tages én time før sengetid på samme klokkeslæt hver aften.
English: Oral administration of tasimelteon to rats throughout organogenesis and lactation resulted in persistent reductions in body weight, delayed sexual maturation and physical development, neurobehavioural impairment in offspring at the highest dose tested, andreduced body weight in offspring at the mid-dose tested.
Danish: Oral administration af tasimelteon til rotter i hele organogenese- og laktationsperioden medførte vedholdende reduktion i kropsvægt, forsinket kønsmodning og fysisk udvikling og neuroadfærdsmæssig funktionsnedsættelse hos afkommet ved den højeste dosis og nedsat kropsvægt af afkommet ved den mellemste dosis.
English: Use of tasimelteon should be avoided in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy: the exposure of tasimelteon decreased by approximately 90% when co-administered with rifampin 600 mg (after 11 days of rifampin 600 mg per day).
Danish: Anvendelse af tasimelteon bør undgås i kombination med rifampicin og andre CYP3A4-induktorer på grund af potentielt stor mindskelse af eksponeringen for tasimelteon med nedsat virkning: Eksponeringen for tasimelteon blev mindsket med ca. 90 % ved koadministration med rifampicin 600 mg (efter 11 dage med rifampicin 600 mg dagligt).
English: Medicinal products that inhibit CYP1A2 and CYP3A4 have been shown to alter the metabolism of tasimelteon in vivo.
Danish: Lægemidler, der hæmmer CYP1A2 og CYP3A4, er påvist at ændre metaboliseringen af tasimelteon in vivo.
English: Contents of the pack and other information What HETLIOZ contains
Danish: Pakningsstørrelser og yderligere oplysninger HETLIOZ indeholder:
English: In SET, tasimelteon entrained circadian rhythms at month 1 at a significantly higher rate than placebo as measured by aMT6s and cortisol (20% vs. 2.6 % and 17.5% vs 2.6% respectively).
Danish: I SET regulerede tasimelteon døgnrytmen i måned 1 væsentligt mere end placebo, målt ved aMT6s og kortisol (henholdsvis 20 % sammenholdt med 2,6 %, og 17,5 % sammenholdt med 2,6 %).
English: Patients were treated for approximately 12 weeks with tasimelteon 20 mg one hour prior to bedtime, at the same time every night.
Danish: Patienterne blev i ca. 12 uger behandlet med tasimelteon 20 mg én time før sengetid på samme klokkeslæt hver aften.
English: Because of individual differences in each person's body rhythms, it could take weeks or months for you to notice an improvement in your symptoms.
Danish: På grund af individuelle forskelle i kropsrytme kan det tage uger eller op til tre måneder, før du mærker bedring i dine symptomer.
English: Dyspepsia, nausea, dry mouth
Danish: Dyspepsi, kvalme, mundtørhed
English: White printing ink Shellac
Danish: Hvid trykfarve Shellac
English: What you need to know before you take HETLIOZ Do not take HETLIOZ if
Danish: Det skal du vide, før du begynder at tage HETLIOZ Tag ikke HETLIOZ:
English: - The active substance is tasimelteon.
Danish: − Aktivt stof: tasimelteon.
English: Package leaflet: Information for the patient HETLIOZ 20 mg hard capsules
Danish: Indlægsseddel: Information til patienten HETLIOZ, hårde kapsler, 20 mg
English: In pregnant rabbits administered tasimelteon during the period of organogenesis, embryolethality and embryofoetal toxicity (reduced foetal body weight and delayed ossification) were observed at the highest dose tested (200 mg/kg/day).
Danish: Ved indgift af tasimelteon til drægtige kaniner i organogeneseperioden iagttoges embryoletalitet og embryoføtal toksicitet (nedsat føtal kropsvægt og forsinket ossifikation) ved den højeste testede dosis (200 mg/kg/dag).
English: Tasimelteon is extensively metabolised.
Danish: Tasimelteon metaboliseres vidtgående.
English: Store in the original container and keep the bottle tightly closed in order to protect from moisture and light.
Danish: Opbevares i den originale emballage, som holdes tæt tillukket for at beskytte mod fugt og lys.
English: Daytime sleep time on 25% most symptomatic days (minutes)(3),(4)
Danish: Søvntid om dagen på de 25 % mest symptomprægede dage (minutter)(3),(4)
English: It is used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults who are totally blind.
Danish: Det anvendes til behandling af søvnforstyrrelsen Non-24-Hour Sleep-Wake Disorder (Non-24) hos voksne, der er totalt blinde.