FrancophonIA/ELRC3.0 huggingface dataset:
English: Slowly push the plunger all the way down until the syringe is empty.
Danish: Tryk langsomt stemplet helt i bund, indtil injektionssprøjten er tom (se figur J).
English: Multipack: 3 (3 packs of 1) pre-filled syringes.
Danish: 3 (3 x 1) fyldte injektionssprøjter (multipakning) 3 (3 x 1) fyldte penne (multipakning)
English: Lymphadenitis
Danish: Lymfadenitis
English: What Zinbryta is and what it is used for What you need to know before you use Zinbryta How to use Zinbryta
Danish: Det skal du vide, før du begynder at bruge Zinbryta Sådan skal du bruge Zinbryta Bivirkninger
English: Caution - do not recap the Zinbryta pre-filled syringe.
Danish: Pas på − sæt ikke hætten på den fyldte Zinbryta injektionssprøjte igen.
English: Common side effects (These may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 patienter)
English: Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab
Danish: Zinbryta 150 mg injektionsvæske, opløsning, i fyldt injektionssprøjte Zinbryta 150 mg injektionsvæske, opløsning, i fyldt pen daclizumab
English: Preparing for your injection
Danish: Klargøring til injektionen
English: Skin exfoliation
Danish: Afskalning af huden
English: • alcohol wipe
Danish: • spritserviet
English: Step 5: Gently pinch your injection site Gently pinch the skin around the cleaned injection site using thumb and forefinger to create a slight bulge.
Danish: Klem forsigtigt om huden omkring det rengjorte injektionssted med tommelfingeren og pegefingeren for at lave en lille bule (se figur H).
English: • paleness
Danish: • bleghed
English: Supplies needed for your Zinbryta injection • Zinbryta pre-filled syringe
Danish: Nødvendigt udstyr til din injektion med Zinbryta
English: Lymphocyte count decreased
Danish: Nedsat antal lymfocytter
English: Gauze Pad Adhesive Bandage
Danish: Selvklæbe nde bandage eller plaster
English: Do not place Zinbryta pen back into the refrigerator after warming to room temperature.
Danish: Sæt ikke Zinbryta pennen i køleskabet igen efter opvarmning til stuetemperatur.
English: Discontinuation due to skin reactions was 4% in Zinbryta-treated patients.
Danish: 4% af de Zinbryta-behandlede patienter seponerede behandlingen på grund af hudreaktioner.
English: • Do not place Zinbryta back into the refrigerator after warming to room temperature.
Danish: • Sæt ikke Zinbryta tilbage i køleskab, efter det har opnået stuetemperatur.
English: Each pre-filled pen contains 150 mg of daclizumab in 1 mL solution for injection.
Danish: Hver fyldte pen indeholder 150 mg daclizumab i 1ml injektionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen
Danish: Zinbryta 150 mg injektionsvæske, opløsning, i fyldt injektionssprøjte Zinbryta 150 mg injektionsvæske, opløsning, i fyldt pen
English: Glass Barrel
Danish: Kanyleh ætte
English: Alcohol Wipe
Danish: Mave-tarm-kanalen
English: Eczema nummular
Danish: Nummulært eksem
English: Medicine Window
Danish: Medicinvindue
English: Step 7: Remove the pre-filled syringe from your injection site
Danish: Trin 7: Fjern den fyldte injektionssprøjte fra injektionsstedet Træk kanylen lige ud (se figur K).
English: Posology
Danish: Anamnese
English: Each pre-filled pen contains a pre-filled syringe, containing 150 mg of daclizumab in 1 mL solution for injection.
Danish: Hver fyldt pen indeholder en fyldt injektionssprøjte med 150 mg daclizumab i 1 ml injektionsvæske, opløsning.
English: Each pre-filled syringe contains 150 mg of daclizumab in 1 mL solution for injection.
Danish: Hver fyldte injektionssprøjte indeholder 150 mg daclizumab i 1 ml injektionsvæske, opløsning.
English: Respiratory tract infection
Danish: Luftvejsinfektion
English: Eczema†
Danish: Eksem†
English: External heat sources such as hot water must not be used to warm Zinbryta.
Danish: Zinbryta må ikke opvarmes med eksterne varmekilder såsom varmt vand.
English: • sore throat, tonsillitis (pharyngitis, laryngitis)
Danish: • ondt i halsen, betændelse i mandlerne (svælgkatar, strubekatar)
English: Excipient related considerations
Danish: Overvejelser relateret til hjælpestoffer
English: Do not place Zinbryta pre-filled syringe back into the refrigerator after warming to room temperature.
Danish: Sæt ikke den fyldte Zinbryta injektionssprøjte tilbage i køleskab, efter den har opnået stuetemperatur.
English: and C. If your blood test shows that you have some liver problems, your doctor will decide whether to start Zinbryta - at least monthly blood tests during treatment, as close as possible before each dose of
Danish: - mindst månedlige blodprøver under behandlingen, så tæt på hver dosis af Zinbryta som muligt, og hyppigere, hvis lægen beslutter, at det er nødvendigt.
English: psoriasis)
Danish: Pyreksi*
English: Clinical endpoints Number of patients Annualised relapse rate Rate ratio [95% CI]
Danish: Kliniske endepunkter Antal patienter Årlig attakrate
English: • Rare (≥1/10, 000 to <1/1,000)
Danish: • Meget sjælden (<1/10.000)
English: This means that symptoms will come back.
Danish: Det vil få symptomerne til at komme igen.
English: Keep the bottle with you so that you can easily describe what you have taken.
Danish: Tag flasken med dig, så du let kan beskrive, hvad du har taget.
English: - Take the medicine by mouth.
Danish: - Tag lægemidlet gennem munden.
English: • At the request of the European Medicines Agency;
Danish: • - på anmodning fra Det Europæiske Lægemiddelagentur
English: Do not take a double dose.
Danish: Du skal ikke tage en dobbelt dosis.
English: 48155 Münster Germany
Danish: 48155 Münster
English: Take your next dose at the usual time the next day.
Danish: Tag næste dosis til sædvanlig tid næste dag.
English: 3 years After first opening of the bottle: 30 days
Danish: 3 år Efter anbrud af flasken: 30 dage
English: Very common: may affect more than 1 in 10 people - headache
Danish: Meget almindelig: forekommer hos mere end 1 ud af 10 personer - hovedpine
English: <2.0 from the average of Day 112 and Day 183 compared to baseline
Danish: <2,0 fra gennemsnittet for dag 112 og dag 183 i forhold til baseline
English: - Do not use this medicine after the expiry date which is stated on the botttle and the carton.
Danish: - Brug ikke dette lægemiddel efter den udløbsdato, der står på etiketten og på kartonen.
English: This is because HETLIOZ has not been tested in people under 18 years of age and the effects are unknown.
Danish: Dette skyldes, at HETLIOZ ikke er testet hos personer under 18 år, og virkningerne kendes ikke.
English: Timing of sleep
Danish: Tidspunkt for søvn
English: Respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures employed.
Danish: Respiration, puls, blodtryk og andre relevante vitale tegn overvåges, og der iværksættes generel støttende behandling.
English: A risk to the breast-fed child cannot be excluded.
Danish: Risiko for brystbarnet kan ikke udelukkes.
English: Try to take the medicine at the same time every night.
Danish: Prøv at tage lægemidlet på samme klokkeslæt hver aften.
English: Alanine aminotransferase increased
Danish: Alaninaminotransferase forhøjet
English: Potential effect of alcohol on tasimelteon
Danish: Potentiel virkning af alkohol på tasimelteon
English: Placebo p-value
Danish: Placebo p-værdi
English: Do not give HETLIOZ to children under the age of 18 years.
Danish: Giv ikke HETLIOZ til børn under 18 år.
English: Do not stop taking HETLIOZ without talking to your doctor.
Danish: Du må ikke holde op med at tage HETLIOZ uden at have talt med lægen.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen indsender den første periodiske opdaterede sikkerhedsindberetning for dette lægemiddel senest seks måneder efter godkendelsen.
English: EXP Use within 30 days after first opening.
Danish: EXP Anvendes senest 30 dage efter anbrud.
English: - Swallow the capsule whole.
Danish: - Synk kapslen hel.
English: Timing of sleep (minutes)(1),(3)
Danish: Tidspunkt for søvn (minutter)(1),(3)
English: Less than 1% of the dose was excreted in urine as the parent compound.
Danish: Under 1 % af dosis blev udskilt i urinen som moderstoffet.
English: As a precautionary measure, it is preferable to avoid the use of tasimelteon during pregnancy.
Danish: Som forsigtighedsregel må det foretrækkes at undgå anvendelse af tasimelteon under graviditet.
English: The size of the capsule is ‘size 1' (dimensions 19.4 x 6.9 mm).
Danish: Kapslerne er af størrelse 1 (19,4 x 6,9 mm).
English: The components of the scale can be found in Table 2.
Danish: Skalaens komponenter er angivet i Tabel 2
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • - når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The mean absolute oral bioavailability of tasimelteon is 38%.
Danish: Den gennemsnitlige absolutte orale biotilgængelighed af tasimelteon er 38 %.
English: It was rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse.
Danish: Der var følgende skalatrin: 1 = meget stærkt forbedret; 2 = stærkt forbedret; 3 = minimalt forbedret; 4 = ingen ændring; 5 = minimalt forværret; 6 = stærkt forværret; eller 7 = meget stærkt forværret.
English: Do not pass it on to others.
Danish: Lad derfor være med at give lægemidlet til andre.
English: HETLIOZ is intended for chronic use.
Danish: HETLIOZ er til kronisk anvendelse.
English: See section 4.8 for safety information.
Danish: 4.8 vedrørende sikkerhedsoplysninger.
English: Each bottle has a child-resistant cap and contains 30 hard capsules.
Danish: Hver flaske har børnesikret låg og indeholder 30 hårde kapsler.
English: Entrainment in Non-24-Hour Sleep-Wake Disorder
Danish: Regulering ved Non-24-Hour Sleep-Wake Disorder
English: The European Medicines Agency has deferred the obligation to submit the results of studies with HETLIOZ in one or more subsets of the paediatric population who are totally blind with Non-24.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med HETLIOZ i en eller flere undergrupper af den pædiatriske population, som er totalt blinde og har Non-24.
English: The safety and efficacy of tasimelteon in children and adolescents aged 0 to 18 years have not been established.
Danish: HETLIOZs sikkerhed og virkning hos børn og unge fra 0 til 18 år er ikke fastlagt.
English: Sleep disorder, insomnia, abnormal dreams
Danish: Søvnforstyrrelser, søvnløshed, abnorme drømme
English: Phenolic glucuronidation is the major phase II metabolic route.
Danish: Phenol-glukuronidering er den vigtigste fase II-metaboliseringsvej.
English: - Skip the missed dose.
Danish: - Overspring den glemte dosis.
English: You are allergic to tasimelteon or any of the other ingredients of this medicine (listed in section 6).
Danish: hvis du er allergisk over for tasimelteon eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: >30 minutes increase and a standard deviation <2 hours during double-masked phase
Danish: Forøgelse >30 minutter og standardafvigelse <2 timer i den dobbeltblinde fase
English: Therefore, your doctor may ask you to take HETLIOZ for up to 3 months before checking if it is working for you.
Danish: Derfor vil lægen måske bede dig tage HETLIOZ i op til tre måneder og vil først derefter kontrollere, om det virker på dig.
English: There is limited clinical experience with the effects of an overdose of tasimelteon.
Danish: Der foreligger kun begrænsede kliniske erfaringer med virkningerne af en overdosis af tasimelteon.
English: Hard capsules should be swallowed whole.
Danish: De hårde kapsler skal synkes hele.
English: Tasimelteon clearance does not appear to be affected by polymorphisms in these enzymes.
Danish: Tasimelteon-clearance synes ikke påvirket af polymorfismer i disse enzymer.
English: Tasimelteon This medicine is subject to additional monitoring.
Danish: Tasimelteon Dette lægemiddel er underlagt supplerende overvågning.
English: - It is best to take HETLIOZ on an empty stomach as food can reduce the amount of the medicine that is absorbed into your body.
Danish: - Tag helst HETLIOZ på tom mave, da føde kan nedsætte den mængde af lægemidlet, der optages i kroppen.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om dette lægemiddels sikkerhed.
English: The body controls these rhythms through many pathways including increases and decreases in the production of the hormone melatonin.
Danish: Kroppen regulerer disse rytmer ad en lang række veje, herunder gennem tiltagende og aftagende produktion af hormonet melatonin.
English: Table 1: Summary of Adverse Drug Reactions System Organ Class
Danish: Tabel 1: Oversigt over bivirkninger Systemorganklasse Meget almindelig
English: Race Race does not affect apparent clearance of tasimelteon.
Danish: Race Race har ingen betydning for den tilsyneladende clearance af tasimelteon.
English: B. CONDITIONS OR RESTRICTIONS
Danish: BETINGELSER ELLER BEGRÆNSNINGER
English: After taking tasimelteon, patients should limit their activity to preparing to go to bed and not use machines because tasimelteon can impair performance of activities requiring complete mental alertness.
Danish: Efter at have taget tasimelteon bør patienten begrænse sin aktivitet til at gøre sig klar til at gå i seng og undgå at anvende maskiner, da tasimelteon kan forringe præstationerne ved aktiviteter, der kræver fuld årvågenhed.
English: (1) Higher numbers indicates improvement (2) Sensitivity Analysis (3) P-value was based on analysis of covariance model, units are LS mean minutes (4) Lower numbers indicates improvement (5) Post-hoc analysis
Danish: (1)Højere tal svarer til forbedring (2) Følsomhedsanalyse (3) P-værdien var baseret på kovariansanalyse; enhederne er mindste kvadraters gennemsnit, minutter (4) Lavere tal svarer til forbedring (5) Post hoc-analyse
English: As with the management of any overdose, general symptomatic and supportive measures should be used, along with immediate gastric lavage, where appropriate.
Danish: Som ved enhver anden overdosis anvendes generelle symptomatiske og støttende foranstaltninger samt øjeblikkelig maveskylning, når dette er hensigtsmæssigt.
English: This type of medicine is called a “melatonin agonist” that acts as a regulator of daily body rhythms.
Danish: Denne type lægemiddel kaldes en “melatoninagonist” og virker som en regulator af kroppens døgnrytme.
English: The active substance in HETLIOZ, tasimelteon, is able to act as a time-keeper for the body rhythms and resets them each day.
Danish: Det aktive stof i HETLIOZ, tasimelteon, kan virke som en tidstager for kroppens rytmer og regulere dem hvert døgn.
English: The recommended dose is one capsule every night, taken one hour before you go to bed.
Danish: Den anbefalede dosis er én kapsel hver aften, som tages en time før sengetid.
English: There are no data on the effects of tasimelteon on human fertility.
Danish: Der foreligger ingen data om virkningerne af tasimelteon på menneskers fertilitet.
English: Some examples include atenolol, metoprolol, and propanolol.
Danish: Som eksempel kan nævnes atenolol, metoprolol og propranolol.
English: This reduction in exposure is not considered clinically relevant and therefore no dose adjustment is necessary.
Danish: Denne lavere eksponering anses ikke for klinisk relevant, og der behøves ikke dosisjustering.
English: This includes the GABA receptor complex, the binding site for sedative hypnotics, and receptors that bind neuropeptides, cytokines, serotonin, noradrenaline, acetylcholine, and opiates.
Danish: Dette gælder således GABA-receptorkomplekset, bindingsstedet for sedative hypnotika samt receptorer, der binder neuropeptider, cytokiner, serotonin, noradrenalin, acetylkolin og opiater.
English: Titanium dioxide Brilliant Blue FCF Erythrosine
Danish: Titaniumdioxid Brilliant Blue FCF Erythrosin
English: In SET, patients in the tasimelteon group had, at baseline, an average 195 minutes of nighttime sleep and 137 minutes of daytime nap time on the 25% of most symptomatic nights and days, respectively.
Danish: I SET havde patienterne i tasimelteon-gruppen ved baseline i gennemsnit henholdsvis 195 minutters nattesøvn og 137 minutters lur i dagtimerne på de 25 % mest symptomprægede nætter og dage.
English: Patients should be instructed to initiate HETLIOZ treatment without regard to circadian phase.
Danish: Patienten bør instrueres i at påbegynde behandlingen med HETLIOZ uden hensyn til fasen i døgnrytmen.
English: Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH03
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, melatoninreceptoragonister, ATC-kode: N05CH03:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner bedes indberette alle formodede bivirkninger ved hjælp af det nationale indberetningssystem, der er anført i bilag V.
English: CYP2C9 (18.8%) and CYP2C19 (15.1%) also contribute to the metabolism of tasimelteon.
Danish: CYP2C9 (18,8 %) og CYP2C19 (15,1 %) bidrager også til tasimelteons metabolisering.
English: If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking HETLIOZ.
Danish: Hvis ét eller flere af ovenstående punkter passer på dig (eller du ikke er sikker), skal du tale med lægen eller apotekspersonalet, inden du tager HETLIOZ.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har en formodning om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktionsog udviklingstoksicitet.
English: If you become pregnant while taking HETLIOZ, consult your doctor immediately as it is recommended not to take HETLIOZ while you are pregnant or breast feeding.
Danish: Hvis du bliver gravid, mens du tager HETLIOZ, skal du straks kontakte lægen, da det anbefales ikke at bruge HETLIOZ, når man er gravid eller ammer.
English: There was no apparent relationship between tasimelteon CL/F and renal function, as measured by either estimated creatinine clearance or eGFR.
Danish: Der var ingen åbenbar sammenhæng mellem CL/F af tasimelteon og nyrefunktionen målt enten som den beregnede kreatininclearance eller eGFR.
English: The mean terminal elimination half-life ± standard deviation of the main metabolites ranges from 1.3 ± 0.5 to 3.7 ± 2.2.
Danish: Den terminale gennemsnitlige eliminationshalveringstid ± standardafvigelse for hovedmetabolitterne spænder fra 1,3 ± 0,5 til 3,7 ± 2,2.
English: The average timing of sleep relative to an individual's desired period for consolidated sleep over at least one circadian period was assessed.
Danish: Det gennemsnitlige søvntidspunkt blev bestemt i forhold til patientens ønskede periode med samlet søvn i løbet af mindst én cirkadiansk periode.
English: Intravenous fluids should be administered as needed.
Danish: Intravenøs væske gives efter behov.
English: >45 minutes increase in average nighttime sleep duration
Danish: >45 minutters forøgelse af gennemsnitlig søvnvarighed om natten
English: The most frequently reported adverse reactions were mostly mild to moderate in severity and transient in nature.
Danish: De hyppigst indberettede bivirkninger var hovedsagelig af lette til moderate og af forbigående art.
English: There are no or limited amount of data from the use of tasimelteon in pregnant women.
Danish: Der foreligger ingen eller kun begrænsede oplysninger om anvendelse af tasimelteon hos gravide kvinder.
English: After taking HETLIOZ, you should get ready to go to bed and only carry out activities that you would normally do before going to bed.
Danish: Når du har taget HETLIOZ, skal du gøre dig klar til at gå i seng og kun gøre, hvad du plejer at gøre, før du går i seng.
English: Tasimelteon and its most abundant metabolites have no appreciable affinity for more than 160 other pharmacologically relevant receptors.
Danish: Hverken tasimelteon eller dets fremherskende metabolitter har nævneværdig affinitet til mere end 160 andre farmakologisk relevante receptorer.
English: Repeated once daily dosing with tasimelteon does not result in changes in pharmacokinetic parameters or significant accumulation of tasimelteon.
Danish: Gentagen dosering med tasimelteon én gang dagligt medfører ingen ændringer i farmakokinetiske parametre eller nævneværdig akkumulering af tasimelteon.
English: The pharmacokinetics of tasimelteon is linear over doses ranging from 3 to 300 mg (0.15 to 15 times the recommended daily dosage).
Danish: Farmakokinetikken af tasimelteon er lineær i dosisområdet 3 til 300 mg (0,15 til 15 gange den anbefalede daglige dosis).
English: Dose and timing
Danish: Dosis og tidsplan
English: The apparent oral volume of distribution at steady state of tasimelteon in young healthy subjects is approximately 59 - 126 L. At therapeutic concentrations, tasimelteon is about 88.6 - 90.1% bound to proteins.
Danish: Det tilsyneladende steady state fordelingsvolumen ved oral indgift af tasimelteon til unge raske forsøgspersoner er ca. 59-126 l. Ved terapeutiske koncentrationer er tasimelteon ca. 88,6-90,1 % proteinbundet.
English: On some psychomotor test measures (intoxication, drunk, alertness/drowsiness, balance platform test), there was a trend towards greater effects of tasimelteon plus ethanol versus ethanol alone, but the effects were not deemed significant.
Danish: For visse psykomotoriske testparametre (intoksikation, vågenhed/døsighed, platformtest af balanceevne) var der tendens til større virkning af tasimelteon plus ethanol end af ethanol alene, men virkningerne blev ikke anset for væsentlige.
English: The most frequent adverse reactions leading to discontinuation were: somnolence (0.23%), nightmare (0.23%), and headache (0.17%).
Danish: De hyppigste bivirkninger, der medførte seponering, var følgende: Somnolens (0,23 %), mareridt (0,23 %) og hovedpine (0,17 %).
English: Following oral administration of radiolabeled tasimelteon, 80% of total radioactivity was excreted in urine and approximately 4% in feces, resulting in a mean recovery of 84%.
Danish: Efter oral administration af radioaktivt mærket tasimelteon blev 80 % af den totale radioaktivitet udskilt i urinen og ca. 4 % cent i fæces, svarende til en gennemsnitlig genfinding på 84 %.
English: These receptors are thought to be involved in the control of circadian rhythms.
Danish: Disse receptorer menes at være involveret i reguleringen af døgnrytmen.