FrancophonIA/ELRC3.0 huggingface dataset:
English: Effects of Tasimelteon 20 mg Treatment on Clinical Response in Non-24 Tasimelteon 20 mg Placebo
Danish: Klinisk respons på behandling med 20 mg tasimelteon ved Non-24 Tasimelteon 20 mg Placebo % forskel pværdi
English: Patients treated with tasimelteon experienced an overall improvement in clinical global functioning (CGIC = 2.6) as compared to patients treated with placebo who showed no improvement status (CGI-C = 3.4) compared to the severity of Non-24 at baseline (LS mean difference = -0.8; p=0.0093) (Table 4).
Danish: Respons bestemt på parametre for global klinisk funktion De patienter, der blev behandlet med tasimelteon, opnåede en samlet bedring i global klinisk funktion (CGIC = 2,6), mens de placebobehandlede patienters status var ingen bedring (CGI-C = 3,4) fra baseline-sværhed af Non-24 (forskel i mindste kvadraters gennemsnit = -0,8; p=0,0093) (Tabel 4 ).
English: HETLIOZ has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing HETLIOZ to patients with severe hepatic impairment.
Danish: 5.2), HETLIOZ er ikke undersøgt hos patienter med svær leverfunktionsnedsættelse (Child-Pugh klasse C); forsigtighed anbefales derfor ved ordination af HETLIOZ til patienter med svært nedsat leverfunktion.
English: If you stop taking HETLIOZ
Danish: Hvis du holder op med at tage HETLIOZ
English: In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofoetal mortality, neurobehavioural impairment, and decreased growth and development in offspring) at doses greater than those used clinically.
Danish: I dyreforsøg medførte indgift af tasimelteon i drægtighedsperioden udviklingstoksicitet (embryoføtal mortalitet, neuroadfærdsmæssig funktionsnedsættelse og nedsat vækst og udvikling hos afkommet) ved doser over de kliniske doser.
English: Hard capsule core Lactose anhydrous Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium sterate
Danish: Kernen i hårde kapsler Lactose, vandfrii Mikrokrystallinsk cellulose Croscarmellosenatrium Silica, kolloid vandfri Magnesiumstearat
English: Strong CYP3A4 inducers (e.g. rifampin)
Danish: Stærke CYP3A4-induktorer (f.eks. rifampicin)
English: HETLIOZ hard capsules contain lactose.
Danish: HETLIOZ, hårde kapsler, indeholder lactose.
English: Clinical response in sleep-wake amount and timing measures SET and RESET evaluated the duration and timing of nighttime sleep and daytime naps via patient-recorded diaries.
Danish: Klinisk respons målt på varighed og tidspunkt af søvn-vågen tilstand SET og RESET fastlagde varighed og tidspunkt for søvn om natten og lur i dagtimerne via dagbog ført af patienten.
English: Renal impairment The pharmacokinetic profile of a 20 mg dose of tasimelteon was compared among 8 subjects with severe renal impairment (estimated glomerular filtration rate [eGFR] ≤ 29 mL/min/1.73m2), 8 subjects with end stage renal disease (ESRD) (GFR < 15 mL/min/1.73m2) requiring hemodialysis, and 16 healthy matched controls.
Danish: Den farmakokinetiske profil af en 20 mg dosis af tasimelteon blev sammenlignet mellem 8 personer med svært nedsat nyrefunktion (beregnet glomerulær filtrationshastighed [eGFR] ≤ 29 ml/min/1,73 m2), 8 personer med hæmodialysekrævende terminal nyresygdom (GFR < 15 ml/min/1,73 m2) og 16 matchede raske kontrolpersoner.
English: Entrainment plus a score ≥3 on this scale, called Non-24 Clinical Response Scale (N24CRS) was required to be classified as a clinical responder.
Danish: Patienterne blev klassificeret som kliniske respondere, når de blev reguleret og fik en score ≥3 på denne skala, der blev benævnt Non-24 Clinical Response Scale (N24CRS).
English: Other medicines and HETLIOZ
Danish: Brug af anden medicin sammen med HETLIOZ
English: Physicians should evaluate patient response to tasimelteon 3 months after treatment initiation utilising a clinician interview to assess their overall functioning with an emphasis on sleep-wake complaints.
Danish: 3 måneder efter påbegyndelse af behandlingen bør patientens respons på tasimelteon vurderes af lægen ved en klinisk samtale, hvor patientens almene funktion bedømmes med vægt på klager over søvn/vågen tilstand.
English: - Keep this leaflet.
Danish: − Gem indlægssedlen.
English: Nighttime sleep on 25% most symptomatic nights (minutes)(3)
Danish: Nattesøvn i de 25 % mest symptomprægede nætter (minutter)(3)
English: Hard capsule shell Gelatin
Danish: Skallen af hårde kapsler Gelatine
English: Dark blue opaque, hard capsule marked with “VANDA 20 mg” in white ink.
Danish: Mørkeblå, uigennemsigtige, hårde kapsler, mærket “VANDA 20 mg” med hvid trykfarve.
English: If you forget to take HETLIOZ
Danish: Hvis du har glemt at tage HETLIOZ
English: Daytime sleep on 25% most symptomatic days
Danish: Søvn i dagtimerne på de 25 % mest symptomprægede dage
English: One HDPE bottle per paperboard carton.
Danish: Hver karton indeholder én HDPE-flaske.
English: Push the cap down and turn counter-clockwise to open the bottle.
Danish: For at åbne flasken skal du trykke låget ned og skrue modsat urretningen.
English: Caution should be used when administering HETLIOZ in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy (see section
Danish: Forsigtighed bør udvises ved administration af HETLIOZ i kombination med rifampicin eller andre CYP3A4-induktorer på grund af den potentielt store mindskelse af eksponeringen for tasimelteon med nedsat virkning (se pkt.
English: - If you get any side effects, talk to your doctor or pharmacist.
Danish: − Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
English: HETLIOZ hard capsules contain the azo colouring agent Orange Yellow S (E110), which may cause allergic reactions.
Danish: HETLIOZ, hårde kapsler, indeholder azofarven Orange Yellow S (E110), der kan bevirke allergiske reaktioner.
English: No evidence of carcinogenic potential was observed in mice; the highest dose tested is approximately 75 times the RHD of 20 mg/day, on a mg/m2 basis.
Danish: Hos mus fandtes ingen evidens for karcinogent potentiale; den højeste testede dosis er ca. 75 gange den anbefalede dosis til mennesker (20 mg dagligt) på mg/m2-basis.
English: This includes: - medicines known to reduce the activity of an enzyme called ‘CYP1A2'.
Danish: Dette gælder således: - lægemidler, der nedsætter aktiviteten af enzymet CYP1A2.
English: Clinical Response in Non-24-Hour Sleep-Wake Disorder The effectiveness of tasimelteon in the treatment of clinical symptoms, including the circadian sleep-wake cycle and clinical global functioning in patients with Non-24 was established in SET and RESET (Table 3).
Danish: Klinisk respons ved Non-24-Hour Sleep-Wake Disorder SET og RESET viste, at tasimelteon er effektivt til behandling af kliniske symptomer, herunder søvn-vågen døgnrytme og global klinisk funktion, hos patienter med Non-24 (Tabel 3).
English: The most abundant metabolites of tasimelteon have less than onetenth of the binding affinity of the parent molecule for both the MT1 and MT2 receptors.
Danish: De fremherskende metabolitter af tasimelteon har under en tiendedel af modermolekylets bindingsaffinitet både til MT1- og MT2-receptorerne.
English: Tasimelteon exposure was increased less than two-fold in subjects with moderate hepatic impairment.
Danish: Eksponeringen for tasimelteon var mindre end dobbelt så stor hos personer med moderat nedsat leverfunktion.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: HETLIOZ bør ikke tages af patienter med de sjældne arvelige lidelser galaktoseintolerans eller Lapp laktasemangel (glukose-/galaktosemalabsorption).
English: No dose adjustment is necessary for patients with renal impairment.
Danish: Der behøves ingen dosisjustering for patienter med nedsat nyrefunktion.
English: Strong CYP3A4 inhibitors (e.g. ketoconazole)
Danish: Stærke CYP3A4-hæmmere (f.eks. ketoconazol)
English: Contains lactose and Orange Yellow S (E110).
Danish: Indeholder lactose og Orange Yellow S (E110).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR 30-COUNT BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL FLASKE MED 30 KAPSLER
English: Caution should be used when administering tasimelteon in combination with fluvoxamine or other strong CYP1A2 inhibitors such as ciprofloxacin and enoxacin because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions: the AUC0-inf and Cmax of tasimelteon increased by 7-fold and 2-fold, respectively, when co-administered with fluvoxamine 50 mg (after 6 days of fluvoxamine 50 mg per day).
Danish: Stærke CYP1A2-hæmmere (f.eks. fluvoxamin, ciprofloxacin og enoxacin) Forsigtighed bør udvises ved administration af HETLIOZ i kombination med fluvoxamin eller andre stærke CYP1A2-hæmmere såsom ciprofloxacin og enoxacin på grund af den potentielt stærkt øgede eksponering for tasimelteon og øget risiko for bivirkninger: AUC0-inf og Cmax af tasimelteon øges med henholdsvis en faktor 7 og 2 ved koadministration med fluvoxamin, 50 mg (efter 6 dage med fluvoxamin 50 mg dagligt).
English: - The other ingredients are lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.
Danish: − Øvrige indholdsstoffer: vandfri laktose, mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid silica og magnesiumstearat.
English: Analyses of entrainment at month 7 in a subset of patients demonstrated that 59% of tasimelteon-treated patients entrained by month 7 indicating that response to treatment may take weeks or months for some patients to respond.
Danish: Hos en undergruppe af patienter viste analyser af døgnrytmereguleringen i måned 7, at 59 % af dem, der blev behandlet med tasimelteon, var blevet reguleret i løbet af måned 7.
English: HETLIOZ hard capsules are opaque dark blue printed with “VANDA 20 mg” in white.
Danish: HETLIOZ, hårde kapsler, er uigennemsigtige mørkeblå kapsler påtrykt “VANDA 20 mg” med hvid farve.
English: - Do not throw away any medicines via wastewater or household waste.
Danish: - Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: HETLIOZ contains lactose
Danish: HETLIOZ indeholder lactose
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Hälsa Pharma GmbH
English: Caution should be used when administering HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors, particularly those which also inhibit other enzymes involved in the clearance of HETLIOZ because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions (see section 4.5).
Danish: Forsigtighed bør udvises ved administration af HETLIOZ i kombination med fluvoxamin eller andre stærke CYP1A2-hæmmere, især dem, der også hæmmer andre enzymer, som er involveret i clearance af HETLIOZ, på grund af potentielt stærkt øget eksponering for tasimelteon og øget risiko for bivirkninger (jf. pkt.
English: Tasimelteon exhibits a greater affinity for the MT2 as compared to the MT1 receptor.
Danish: Tasimelteon har større affinitet for MT2- end for MT1-receptoren.
English: Threshold of Response
Danish: Responstærskel
English: Reporting of side effects
Danish: Oversigt over bivirkninger
English: Therefore, tasimelteon should be taken without food; if patients eat a high-fat meal, it is recommended to wait at least 2 hours before taking tasimelteon.
Danish: Hvis patienten indtager et fedtrigt måltid, anbefales det at vente mindst 2 timer før indgift af tasimelteon.
English: Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Danish: Nedsat nyrefunktion Der anbefales ikke dosisjustering for patienter med nedsat nyrefunktion (se pkt.
English: HETLIOZ should be taken without food; if patients eat a high-fat meal, it is recommended to wait at least 2 hours before taking HETLIOZ (see section 5.2).
Danish: Hvis patienten indtager et fedtrigt måltid, anbefales det at vente mindst to timer, før HETLIOZ tages (se pkt.
English: The pharmacokinetic profile of a 20 mg dose of tasimelteon was compared among 8 subjects with mild hepatic impairment (Child-Pugh Score ≥5 and ≤6 points), 8 subjects with moderate hepatic impairment
Danish: Nedsat leverfunktion Den farmakokinetiske profil af en 20 mg dosis af tasimelteon blev sammenlignet for 8 personer med let nedsat leverfunktion (Child-Pugh Score ≥5 og ≤6 point), 8 personer med moderat nedsat leverfunktion (Child-Pugh Score ≥7 og ≤9 point) og 13 raske matchede kontrolpersoner.
English: Uncommon: may affect up to 1 in 100 people - abnormal or change in taste - blood tests which show changes in the way the liver is working (aspartate aminotransferase and gamma-glutamyl transferase) - increase in daytime urination - nightmares - ringing in the ears - feeling foggy in the head
Danish: Ikke almindelig: forekommer hos op til 1 ud af 100 personer) - unormale eller ændrede smagsindtryk - ændring i blodprøver, der viser hvordan leveren fungerer (aspartataminotransferase og gammaglutamyltransferase)
English: HETLIOZ contains Orange Yellow S (E110)
Danish: HETLIOZ indeholder Orange Yellow S (E110)
English: Reproductive toxicology
Danish: Reproduktionstoksikologi:
English: In rats, the incidence of liver tumours was increased in males (adenoma and carcinoma) and females (adenoma) at 100 and 250 mg/kg/day; the incidence of tumours of the uterus (endometrial adenocarcinoma) and uterus and cervix (squamous cell carcinoma) were increased at 250 mg/kg/day.
Danish: Hos rotter var der øget forekomst af levertumorer hos hanner (adenomer og karcinomer) og hunner (adenomer) ved 100 og 250 mg/kg/dag.
English: Therefore, no dose adjustment is needed in patients with mild or moderate hepatic impairment.
Danish: Der behøves derfor ikke dosisjustering hos patienter med let til moderat nedsat leverfunktion.
English: The Clinical Global Impression of Change (CGI-C) is a reflection of the general social, occupational, and health functioning of the patient and is evaluated on a 7-point scale, centered at No Change (4), that investigators used to rate the patients' improvement from baseline in symptoms of global functioning.
Danish: Den vurderes på en 7-punkts skala, der er centreret om No Change (4) og af investigatorerne blev anvendt til at vurdere bedringen fra baseline i symptomer vedrørende global funktion.
English: HETLIOZ contains lactose.
Danish: HETLIOZ indeholder lactose.
English: How HETLIOZ works
Danish: Sådan virker HETLIOZ
English: Subjects with severe renal impairment had a 30% lower CL/F clearance than match controls; however, when variability is taken into account, the different was not significant.
Danish: Hos personer med svært nedsat nyrefunktion var clearance (CL/F) 30 % lavere end hos matchede kontrolpersoner.
English: Major metabolites had 13-fold or less activity at melatonin receptors compared to tasimelteon.
Danish: Aktiviteten af hovedmetabolitterne ved melatoninreceptorerne var mindst 13 gange lavere end af tasimelteon.
English: HETLIOZ 20 mg hard capsules tasimelteon
Danish: HETLIOZ, hårde kapsler, 20 mg tasimelteon
English: Both studies demonstrated the ability of tasimelteon to entrain the master body clock in patients with Non-24 and RESET demonstrated that continued daily dosing of tasimelteon is necessary to maintain entrainment.
Danish: Begge forsøg viste, at tasimelteon er i stand til at regulere det biologiske ur hos patienter med Non-24.
English: No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2).
Danish: Det er ikke nødvendigt med en dosisjustering for patienter med let til moderat nedsat leverfunktion (se pkt.
English: A composite scale of 4 measures of duration and timing of nighttime and daytime sleep and global functioning was used to evaluate clinical response in SET.
Danish: Til vurdering af klinisk respons blev der i SET anvendt en skala sammensat af fire målinger af søvnvarighed og søvntidspunkt om natten og i dagtimerne samt global funktion.
English: Hard capsule.
Danish: Kapsler, hårde
English: An example is fluvoxamine, which is used to treat depression and obsessive compulsive disorder (OCD).
Danish: Et eksempel er fluvoxamin, der anvendes mod depression og mod tvangstanker og tvangshandlinger (obsessiv-kompulsiv lidelse (OCD)), - lægemidler, der nedsætter aktiviteten af enzymet CYP3A4.
English: RESET Study
Danish: SET-undersøgelsen
English: Because symptoms of nighttime sleep disruption and daytime sleepiness are cyclical in patients with Non-24, with severity varying according to the state of alignment of the individual patient's circadian rhythm with the 24-hour day (least severe when fully aligned, most severe when 12 hours out of alignment), efficacy endpoints for nighttime total sleep time and daytime nap duration were based on the 25% of nights with the least nighttime sleep, and the 25% of days with the most daytime nap time.
Danish: Endepunkterne for virkning (total søvntid om natten og varighed af lur i dagtimerne) blev derfor baseret på de 25 % nætter med mindst nattesøvn og de 25 % dage med længst tid med lur i dagtimerne.
English: Tasimelteon acts as a Dual Melatonin Receptor Agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors.
Danish: Tasimelteon er en dobbelt melatoninreceptoragonist med selektiv virkning på MT1- og MT2-receptorer.
English: Patients with Non-24 who are totally blind cannot see light, so their body rhythms shift out of alignment with the 24-hour world, resulting in periods of feeling sleepy during the day and the inability to sleep at night.
Danish: Patienter med Non-24 har cykliske symptomer bestående af afbrudt søvn om natten og søvnighed om dagen.
English: Tasimelteon has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing HETLIOZ to patients with severe hepatic impairment.
Danish: Tasimelteon er ikke undersøgt hos patienter med svær leverfunktionsnedsættelse (Child-Pugh klasse C).
English: Tasimelteon functions as a DMRA at the MT1 and MT2 receptors.
Danish: Tasimelteon virker som en dobbelt melatoninreceptoragonist på MT1- og MT2-receptorer.
English: An example is ketoconazole, which is used to treat fungal infections.
Danish: Et eksempel er ketoconazol, der anvendes til behandling af svampeinfektioner, - lægemidler, der øger aktiviteten af enzymet CYP3A4.
English: HETLIOZ 20 mg hard capsules
Danish: HETLIOZ, hårde kapsler, 20 mg
English: An example is rifampicin, which is used to treat tuberculosis (TB).
Danish: Et eksempel er rifampicin, der anvendes til behandling af tuberkulose, - lægemidler, der nedsætter aktiviteten af enzymet CYP2C19.
English: What HETLIOZ is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Check with your doctor or pharmacist if you are not sure.
Danish: − Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: - medicines called “beta blockers” used to treat high blood pressure and other heart problems.
Danish: Et eksempel er omeprazol, der anvendes til behandling af halsbrand og tilbageløb af maveindholdet (gastroøsofagealt reflukssygdom), - lægemidler af typen betablokkere, der anvendes mod højt blodtryk og andre hjerteproblemer.
English: How to take HETLIOZ
Danish: Sådan skal du tage HETLIOZ
English: Clinical Global Functioning in Non-24 Patients Tasimelteon 20 mg
Danish: Global klinisk funktion hos patienter med Non-24
English: Nighttime sleep on 25% most symptomatic nights >45 minutes increase in average nighttime sleep duration
Danish: Nattesøvn i de 25 % mest symptomprægede nætter
English: CGI-C (LS mean)
Danish: Global klinisk vurdering af ændring (CGI-C)
English: Excipients
Danish: Uforligeligheder
English: MA (EU) number (Invented) name
Danish: (Særnavn) Navn
English: Pack size
Danish: Pakningsstørrelse mg
English: Content (concentration)
Danish: Koncentrat til infusionsvæske, opløsning
English: Route of Administration
Danish: EMA's procedurenr.
English: A further report will be provided at the June meeting.
Danish: Der ville blive fremlagt endnu en rapport på mødet i juni.
English: The first centralised vaccine against bluetongue
Danish: Den første centraliserede vaccine mod bluetongue
English: This can be considered during the ongoing evaluation of the Agency.
Danish: Dette kunne overvejes under den løbende evaluering af agenturet.
English: Collaboration with the FDA
Danish: Samarbejde med FDA
English: The public consultation regarding the proposed policy is planned to start in mid June and finish at the end of September 2009.
Danish: Den offentlige høring om den foreslåede politik forventedes iværksat medio juni og afsluttet ultimo september 2009.
English: The adopted preliminary draft budget (PDB) for 2010 totals €211.8 million.
Danish: Det vedtagne foreløbige budgetforslag (FBF) for 2010 udgjorde i alt 211,8 mio. EUR.
English: The former was delayed due to some performance issues and stability problems.
Danish: Førstnævnte var blevet forsinket på grund af visse problemer med ydeevne og stabilitet.
English: Review of the remuneration system
Danish: Revision af lønsystemet
English: The first switch from prescription-only to non-prescription status of a centrally authorised product took place in 2008.
Danish: Det første skift fra receptpligtig til ikkereceptpligtig status for et centralt godkendt lægemiddel fandt sted i 2008.
English: The year 2010 is the final year covered by the current road map.
Danish: 2010 ville være det sidste år med den nugældende køreplan.
English: The Management Board welcomed the opinion of the Committee as it is of importance to many Member States.
Danish: Bestyrelsen bifaldt udvalgets udtalelse, da den var vigtig for mange medlemsstater.
English: Presentation ‘Building on a risk-intelligence framework'.
Danish: Præsentation af ”Building on a risk-intelligence framework” (at bygge på en risk-intelligenceramme).
English: The Agency adopted a record number of positive opinions in the area of initial evaluations.
Danish: Agenturet vedtog et rekordhøjt antal positive udtalelser i forbindelse med indledende vurderinger.
English: At present, the annual cost of support measures for these products is around €100,000.
Danish: For indeværende lå de årlige støtteudgifter til disse lægemidler på omkring 100 000 EUR.
English: This includes an estimated fee revenue of €158.3 million and a requested Community contribution of €46 million.
Danish: Dette omfattede anslåede gebyrindtægter på 158,3 mio. EUR og et bidrag fra Fællesskabet på 46 mio. EUR.
English: Planning for 2010:
Danish: Planlægning for 2010:
English: The pilot will commence in April 2009 and will run for three months.
Danish: Projektet ville blive iværksat i april 2009 og køre i tre måneder.
English: In 2008, the Agency launched a project to review its corporate identity.
Danish: I 2008 iværksatte agenturet et projekt om at revidere sin virksomhedsidentitet.
English: The Board will discuss this proposal at a future meeting.
Danish: Bestyrelsen ville drøfte dette forslag på et senere møde.
English: The Agency will also consider ways to promote use of its official name rather than the acronym ‘EMEA', which has limited recognition outside of the Agency's closest stakeholder groups.
Danish: Agenturet ville også overveje, hvordan man kunne fremme brugen af det officielle navn i stedet for akronymet "EMEA", som kun i begrænset omfang var kendt uden for agenturets tætteste interessentgrupper.
English: Point 16 on Governance of EU agencies was deferred to the June meeting.
Danish: Punkt 16 om styring af EU's agenturer blev udskudt til mødet i juni.
English: The PDB includes an increase in the establishment plan of 37 posts, with a maximum number of 567 temporary agents.
Danish: Det foreløbige budgetforslag omfattede en stigning i antallet af stillinger på 37 med et maksimalt antal midlertidigt ansatte på 567.