FrancophonIA/ELRC3.0 huggingface dataset:
English: Subcutaneous use vial (glass)
Danish: Fyldt injektionssprøjte (glas)
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn Styrke
English: Pharmaceutical Form
Danish: Lægemiddelform Administration Emballage Paknings-størrelse
English: This summary was last updated in 07-2015.
Danish: Dette sammendrag blev senest ajourført i 07-2015.
English: As a result, patients fall asleep and wake up at unusual times.
Danish: Patienten falder derfor i søvn og vågner på usædvanlige tidspunkter.
English: However, continued treatment would be necessary to maintain the beneficial effects.
Danish: Det kræver imidlertid vedvarende behandling at opretholde de gavnlige virkninger.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hetlioz on 3 July 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Hetlioz den 3. juli 2015.
English: The medicine should be taken without food.
Danish: Lægemidlet skal tages uden samtidig fødeindtagelse.
English: This is a summary of the European public assessment report (EPAR) for Hetlioz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Hetlioz.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hetlioz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Hetlioz opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: These are usually mild or moderate in severity and temporary.
Danish: Disse bivirkninger er sædvanligvis lette eller moderate og er forbigående.
English: Hetlioz is intended for long-term use.
Danish: Hetlioz er beregnet til langtidsbehandling.
English: Other information about Hetlioz
Danish: Andre oplysninger om Hetlioz
English: The recommended dose is one capsule per day, taken one hour before bedtime, at the same time every night.
Danish: Den anbefalede dosis er 1 kapsel dagligt, der tages én time før sengetid på samme klokkeslæt hver aften.
English: In the second study, 57 patients first received Hetlioz for around 11 weeks.
Danish: I den anden undersøgelse fik 57 patienter først Hetlioz i omkring 11 uger.
English: A risk management plan has been developed to ensure that Hetlioz is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Hetlioz anvendes så sikkert som muligt.
English: The most common side effects with Hetlioz (which may affect more than 3 in 100 people) are headache, somnolence, nausea (feeling sick) and dizziness.
Danish: De hyppigste bivirkninger ved Hetlioz (som kan forekomme hos mere end 3 ud af 100 personer), er hovedpine, søvnighed, kvalme og svimmelhed.
English: Regarding safety, Hetlioz was shown to be well tolerated, causing only few mild side effects.
Danish: Hvad sikkerheden angår, blev Hetlioz påvist at tåles godt og kun at medføre få lette bivirkninger.
English: Hetlioz contains the active substance tasimelteon.
Danish: Hetlioz indeholder det aktive stof tasimelteon.
English: What measures are being taken to ensure the safe and effective use of Hetlioz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Hetlioz?
English: The CHMP noted that only around 20% of patients would be able to benefit from treatment with Hetlioz, but in view of the lack of approved treatments for non-24-hour sleep-wake disorder, which is a debilitating condition, this modest response was still considered important.
Danish: CHMP bemærkede, at kun ca. 20 % af patienterne ville kunne få gavn af behandlingen med Hetlioz, men i betragtning af, at der ikke findes godkendte behandlinger af non-24-hour sleep-wake disorder, og at det er en invaliderende sygdom, blev dette beskedne resultat alligevel anset for vigtigt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hetlioz, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Hetlioz, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: What is Hetlioz and what is it used for?
Danish: Hvad er Hetlioz, og hvad anvendes det til?
English: The full EPAR and risk management plan summary for Hetlioz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Hetlioz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the number of patients with non-24-hour sleep-wake disorder is low, the disease is considered ‘rare', and Hetlioz was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 February 2011.
Danish: Da antallet af patienter med non-24-hour sleep-wake disorder er lavt, betragtes sygdommen som "sjælden", og Hetlioz blev udpeget som "lægemiddel til sjældne sygdomme" den 23. februar 2011.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Hetlioz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Hetlioz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The active substance in Hetlioz, tasimelteon, acts on the same receptors as melatonin to promote sleep and regulate sleep patterns.
Danish: Det aktive stof i Hetlioz, tasimelteon, virker på de samme receptorer som melatonin og fremkalder derved søvn, så søvnmønsteret reguleres.
English: Hetlioz is available as 20 mg capsules and can only be obtained with a prescription.
Danish: Hetlioz fås som kapsler (20 mg) og udleveres kun på recept.
English: It is not intended to provide practical advice on how to use Hetlioz.
Danish: Det er ikke en praktisk vejledning i, hvordan Hetlioz bør anvendes.
English: Why is Hetlioz approved?
Danish: Hvorfor blev Hetlioz godkendt?
English: For more information about treatment with Hetlioz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Hetlioz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For the full list of all side effects and restrictions with Hetlioz, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Hetlioz fremgår af indlægssedlen.
English: Non-24hour sleep-wake disorder is a condition that occurs almost exclusively in people who are completely blind, where patients have sleep patterns that are not synchronised with day and night and often follow a cycle that is longer than the standard 24-hour clock.
Danish: Sygdommen non-24-hour sleep-wake disorder optræder næsten udelukkende hos helt blinde personer, idet patientens søvnmønster ikke er synkroniseret med dag og nat, men ofte følger en rytme, der er længere end den normale 24-timers døgnrytme.
English: By taking it at a suitable time each day it can help to reset the sleep-wake cycle to more standard timing.
Danish: Når lægemidlet tages på et passende klokkeslæt hver dag, kan det medvirke til at omstille kroppens søvnrytme til et mere normalt mønster.
English: What are the risks associated with Hetlioz?
Danish: Hvilke risici er der forbundet med Hetlioz?
English: Of the 10 patients who remained on Hetlioz, 9 people remained adjusted to 24-hour clock at the end of the study, compared with 2 of the 10 patients who were switched to placebo.
Danish: Af de 10 patienter, der stadig fik Hetlioz, var 9 stadig tilpasset til 24-timers klokkeslættet i slutningen af undersøgelsen, sammenholdt med 2 ud af de 10 patienter, der skiftede til placebo.
English: A hormone called melatonin plays a key role in co-ordinating the body's sleep-wake cycle.
Danish: Hormonet melatonin spiller en vigtig rolle i reguleringen af kroppens søvnrytme.
English: For practical information about using Hetlioz, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Hetlioz, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Hetlioz used?
Danish: Hvordan anvendes Hetlioz?
English: 20% of patients who received Hetlioz (8 out of 40) were able to adjust to the 24-hour clock after 1 months of treatment, compared with around 3% of patients on placebo (1 out of 38).
Danish: Efter en måneds behandling var 20 % af de patienter, der fik Hetlioz (8 ud af 40) i stand til at tilpasse sig 24-timers klokkeslættet, sammenholdt med ca. 3 % af dem, der fik placebo (1 ud af 38).
English: Hetlioz has been shown to be effective at helping patients adjust to the standard 24-hour clock in 2 main studies.
Danish: To hovedundersøgelser har vist, Hetlioz er effektivt til at hjælpe patienten med at omstille sig til den normale 24-timers døgnrytme.
English: Hetlioz is a medicine used to treat totally blind adults with non-24-hour sleep-wake disorder.
Danish: Hetlioz er et lægemiddel til behandling af søvnforstyrrelsen "non-24-hour sleep-wake disorder" hos voksne, der er totalt blinde.
English: What benefits of Hetlioz have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Hetlioz?
English: In people with normal perception of light and dark, melatonin is produced in hours of darkness and promotes sleep by acting on melatonin receptors in specific areas of the brain.
Danish: Personer med normal opfattelse af lys og mørke danner melatonin, når det er mørkt.
English: Those patients who were able to adjust to the 24-hour clock (20 patients in total) were then given Hetlioz or placebo for a further 8 weeks to study how well the effect of Hetlioz was maintained.
Danish: De patienter, der kunne omstille sig til 24-timers klokkeslættet (i alt 20 patienter), fik derefter i yderligere otte uger enten Hetlioz eller placebo.
English: The main measure of effectiveness was the percentage of patients who were able to adjust to the 24-hour clock, which was calculated by looking at how the amount of melatonin breakdown products changed in the patient's urine over time.
Danish: Det vigtigste mål for virkningen var den procentdel af patienterne, der var i stand til at tilpasse sig til 24-timers døgnrytmen.
English: The first study, which involved a total of 84 totally blind patients with non-24-hour sleep-wake disorder, compared Hetlioz with placebo (a dummy treatment).
Danish: I den første undersøgelse deltog i alt 84 totalt blinde patienter med non-24-hour sleep-wake disorder.
English: Improved results were seen in a subset of patients after 7 months of treatment, which indicate that patients may take weeks or months to respond.
Danish: Efter syv måneders behandling var resultaterne bedre hos en undergruppe af patienterne.
English: How does Hetlioz work?
Danish: Hvordan virker Hetlioz?
English: It must also not be used in the following groups:
Danish: Det må heller ikke anvendes til følgende grupper:
English: This summary was last updated in 01-2012.
Danish: Dette sammendrag blev sidst ajourført i 01-2012.
English: The main measure of effectiveness was how long the patients lived.
Danish: Det primære effektmål var, hvor længe patienterne levede.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Teysuno on 14 March 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Teysuno den 14 marts 2011.
English: The recommended dose for one cycle of treatment is 25 mg/m2 twice a day (in the morning and evening) for three weeks, followed by a one-week rest period.
Danish: Den anbefalede dosis for et behandlingsforløb er 25 mg/m2 to gange om dagen (om morgenen og om aftenen) i tre uger, efterfulgt af en hvileperiode på en uge.
English: Teysuno capsules are taken with water at least one hour before or after a meal.
Danish: Teysuno-kapsler indtages sammen med vand mindst en time før eller efter et måltid.
English: As a result, it prevents the growth of cancer cells and eventually kills them.
Danish: Derved forhindrer det væksten af cancercellerne, der til sidst dør.
English: Both medicines were given with cisplatin.
Danish: Begge lægemidler blev givet med cisplatin.
English: • pregnant or breast-feeding women;
Danish: • gravide eller ammende kvinder
English: • patients who should not be receiving cisplatin.
Danish: • patienter, der ikke må modtage cisplatin.
English: The full EPAR for Teysuno can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Teysuno findes på EMA's websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Teysuno.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Teysuno.
English: Other information about Teysuno
Danish: Andre oplysninger om Teysuno
English: The cycle is repeated every four weeks, including once cisplatin administration is stopped after six cycles.
Danish: Forløbet gentages hver fjerde uge, også når cisplatinbehandlingen stoppes efter seks forløb.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Teysuno.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Teysuno.
English: • patients with a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) as well as patients who, within the previous four weeks, have been treated with a medicine that inhibits this enzyme;
Danish: • patienter med mangel på enzymet dihydropyrimidin dehydrogenase (DPD) og patienter, der inden for de seneste fire uger er blevet behandlet med et lægemiddel, som hæmmer dette enzym
English: It is used in combination with cisplatin (another anticancer medicine).
Danish: Det anvendes i kombination med cisplatin (et andet lægemiddel mod cancer).
English: Teysuno must not be used in people who are hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Danish: Teysuno må ikke anvendes til personer, som er overfølsomme (allergiske) over for nogen af de aktive stoffer eller et eller flere af de øvrige indholdsstoffer.
English: The dose to be taken is calculated based on the active substance tegafur and the patient's body surface area (calculated using the patient's height and weight).
Danish: Dosen, der skal tages, beregnes på basis af det aktive stof tegafur og patientens legemsoverfladeareal (beregnet ved hjælp af patientens højde og vægt).
English: The CHMP decided that Teysuno's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Teysuno er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Teysuno.
English: Tegafur is a ‘prodrug' that is converted in the body to a chemical called 5-fluorouracil (5-FU).
Danish: Tegafur er et ”prodrug”, der omdannes i kroppen til et kemikalie, som hedder 5-fluorouracil (5-FU).
English: It is available as capsules containing 15 mg tegafur with 4.35 mg gimeracil and 11.8 mg oteracil, and as capsules containing 20 mg tegafur with 5.8 mg gimeracil and 15.8 mg oteracil.
Danish: Det findes som kapsler, der indeholder 15 mg tegafur med 4,35 mg gimeracil og 11,8 mg oteracil, og som kapsler, der indeholder 20 mg tegafur med 5,8 mg gimeracil og 15,8 mg oteracil.
English: Teysuno is a medicine that contains the active substances tegafur, gimeracil and oteracil.
Danish: Teysuno er et lægemiddel, der indeholder de aktive stoffer tegafur, gimeracil og oteracil.
English: Treatment with Teysuno capsules was as effective as treatment with 5-FU infusions.
Danish: Behandling med Teysuno-kapsler var lige så effektiv som behandling med 5-FU-infusioner.
English: Patients receiving Teysuno with cisplatin lived for an average of 8.6 months compared with 7.9 months for patients receiving 5-FU with cisplatin.
Danish: De patienter, der modtog Teysuno med cisplatin, overlevede i gennemsnit i 8,6 måneder sammenlignet med 7,9 måneder for de patienter, der modtog 5-FU med cisplatin.
English: Teysuno should only be prescribed by a qualified doctor experienced in treating cancer patients with anticancer medicines.
Danish: Teysuno må kun ordineres af en kvalificeret læge med erfaring i behandling af cancerpatienter med lægemidler mod cancer.
English: 5-FU is similar to pyrimidine, a substance found in the genetic material of cells (DNA and RNA).
Danish: 5-FU ligner pyrimidin, et stof, der findes i cellernes genetiske materiale (dna og rna).
English: • patients with severe kidney problems requiring dialysis;
Danish: • patienter med alvorlige nyreproblemer, der kræver dialyse
English: For more information about treatment with Teysuno, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Teysuno, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Teysuno is used together with cisplatin, in a 4-week cycle starting on the day of the cisplatin administration.
Danish: Teysuno bruges sammen med cisplatin i et 4-ugers forløb, der starter den dag, hvor der gives cisplatin.
English: The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the ‘anti-metabolites' group.
Danish: Det primære aktive stof i Teysuno, tegafur, er et cytotoksisk lægemiddel (et lægemiddel, der dræber celler, som deler sig, såsom cancerceller), som hører til gruppen af antimetabolitter.
English: In the main study, Teysuno was compared with the anticancer medicine 5-FU given as an infusion in 1,053 adults with advanced gastric cancer.
Danish: I hovedundersøgelsen blev Teysuno sammenlignet med lægemidlet 5-FU mod cancer, som blev givet som infusion til 1 053 voksne med fremskreden ventrikelcancer.
English: In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Danish: I kroppen indtager 5-FU pyrimidins plads og forstyrrer de enzymer, der er med til at danne ny dna.
English: What is the risk associated with Teysuno?
Danish: Hvilken risiko er der forbundet med Teysuno?
English: The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU and oteracil by reducing the activity of 5FU in normal, non-cancerous tissue in the gut.
Danish: De to andre aktive stoffer i Teysuno får tegafur til at virke ved lavere doser og med færre bivirkninger: gimeracil hæmmer nedbrydningen af 5-FU, og oteracil nedsætter 5-FU's aktivitet i normalt, ikkekræftramt væv i maven.
English: • patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);
Danish: • patienter med alvorlig leukopeni, neutropeni eller trombocytopeni (for lavt antal hvide blodlegemer eller blodplader i blodet)
English: For the full list of all side effects reported with Teysuno, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Teysuno fremgår af indlægssedlen.
English: In patients treated with Teysuno in combination with cisplatin, the most common severe side effects (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts) and fatigue (tiredness).
Danish: Hos patienter, der behandles med Teysuno kombineret med cisplatin, er de hyppigste alvorlige bivirkninger (som optræder hos flere end 1 ud af 10 patienter) neutropeni (for lavt antal neutrofiler, en type hvide blodlegemer), anæmi (lavt antal røde blodlegemer) og energiløshed (træthed).
English: Teysuno is used to treat adults with advanced gastric (stomach) cancer.
Danish: Teysuno anvendes til behandling af voksne med fremskreden mavekræft (ventrikelcancer).
English: For more information on the use of Teysuno, including how to use it with cisplatin, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Teysuno, herunder hvordan det anvendes sammen med cisplatin, fremgår af produktresuméet (der ligeledes er en del af denne EPAR).
English: Why has Teysuno been approved?
Danish: Hvorfor blev Teysuno godkendt?
English: What is Teysuno?
Danish: Hvad er Teysuno?
English: What is Teysuno used for?
Danish: Hvad anvendes Teysuno til?
English: • patients currently receiving another fluoropyrimidine (a group of anticancer medicines that includes
Danish: • patienter, der modtager et andet fluoropyrimidin-middel (en gruppe lægemidler mod cancer, der omfatter Teysuno), eller som har haft alvorlige, uventede reaktioner over for fluoropyrimidiner
English: How has Teysuno been studied?
Danish: Hvordan blev Teysuno undersøgt?
English: What benefit has Teysuno shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Teysuno?
English: How is Teysuno used?
Danish: Hvordan anvendes Teysuno?
English: How does Teysuno work?
Danish: Hvordan virker Teysuno?
English: ITALY
Danish: ITALIEN
English: To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre korrekt dosering, bør legemsvægten bestemmes så præcist som muligt for at undgå underdosering.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af denne markedsføringstilladelse må informere den Europæiske Kommission om markedsføringsplaner for lægemidlet godkendt ved denne beslutning.
English: Do not use in dogs and cats less than 8 weeks old.
Danish: Bør ikke anvendes til hunde og katte yngre end 8 uger.
English: In the event of contact, wash skin with soap and water.
Danish: Ved hudkontakt, vask med sæbe og vand.
English: Allergic reactions to these substances may occasionally be serious.
Danish: Allergiske reaktioner over for disse stoffer kan undertiden være alvorlige.
English: (e.g. S. xylosus, S. schleiferi, S. epidermidis) is 9.5 %.
Danish: (f.eks. S. xylosus, S. schleiferi, S. epidermidis) er 9,5 %.
English: Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Danish: Brug af præparatet bør baseres på følsomhedstest og tage hensyn til officiel og lokal antibiotikapolitik.
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Danish: Hævelse af ansigt, læber eller øjne eller besvær med at trække vejret er mere alvorlige symptomer og kræver øjeblikkelig lægehjælp.
English: ATCvet code: QJ01DD91.
Danish: ATCvet-kode: QJ01DD91
English: 1348 Louvain-la-Neuve BELGIUM
Danish: 1348 Louvain-la-Neuve BELGIEN
English: Elimination half-life is long - approximately 5.5 days.
Danish: Eliminationshalveringstiden er lang - omkring 5,5 dage.
English: In very rare cases neurological signs and injection site reactions have been reported after the use of the product.
Danish: I meget sjældne tilfælde er neurologiske symptomer og reaktioner på injektionsstedet blevet rapporteret efter anvendelse af produktet.