FrancophonIA/ELRC3.0 huggingface dataset:
English: You may also have a high temperature (fever) and abnormal blood test results.
Danish: Du kan evt. også få feber og unormale blodprøve-resultater.
English: Psychotic or manic symptoms
Danish: Psykotiske eller maniske symptomer
English: A monitoring programme to assess the abuse and misuse potential of modafinil was conducted between 1999 and 2007, and consisted of online monitoring of modafinil references and messages.
Danish: Der blev mellem 1999 og 2007 gennemført et overvågningsprogram for at vurdere risikoen for misbrug og forkert brug af modafinil, og det bestod af onlineovervågning af modafinilhenvisninger og -meddelelser.
English: Almost half of all the adverse events reported for modafinil appear to be reported in use outside of the approved indications.
Danish: Næsten halvdelen af alle de bivirkninger, der er indberettet for modafinil, synes at være indberettet uden for de godkendte indikationer.
English: The mechanism of action is not entirely understood, but the most consistent findings of the various studies performed are the inhibitory effects on the dopamine and norepinephrine transporters.
Danish: Virkningsmekanismen er ikke fuldt klarlagt, men de mest konsistente resultater af de forskellige undersøgelser, som er udført, er den hæmmende virkning på dopamin- og noradrenalintransportørerne.
English: Toxicology studies by single and repeated dosing have revealed no particular toxic action in animals.
Danish: Toksikologiske studier ved enkelt og gentagen indgift har ikke afsløret nogen specielle, toksiske reaktioner hos dyr.
English: The other indications for modafinil are excessive sleepiness associated with:
Danish: De andre indikationer for modafinil er overdreven søvnighed associeret med:
English: In addition, a contraindication in patients with uncontrolled hypertension or cardiac arrhythmia is deemed necessary to prevent serious complications in patients with such co-morbidities.
Danish: Derudover anses en kontraindikation for patienter med ukontrolleret hypertension eller hjertearytmi for nødvendig for at forhindre alvorlige komplikationer hos patienter med sådanne co-morbiditeter.
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations, subject to the conditions set out in annex IV, for which the amendments to the Summary of Product Characteristics and Package Leaflet are set out in Annex III for modafinil-containing products (see Annex I).
Danish: Som følge heraf har CHMP anbefalet at opretholde markedsføringstilladelserne, forudsat at betingelserne i bilag IV overholdes, for hvilke ændringerne i produktresuméet og indlægssedlen fremgår af bilag III for lægemidler indeholdende modafinil (se bilag I).
English: Having considered the data presented, the CHMP recognises the existence of a consistent short-term effect of modafinil in all variables measured.
Danish: Efter at have behandlet de forelagte data anerkender CHMP, at der er en konsistent korttidsvirkning af modafinil ved alle målte variabler.
English: Physicians prescribing modafinil for an extended time should periodically re-evaluate the long-term use for the individual patients as the long-term efficacy of modafinil has not been evaluated (> 9 weeks).
Danish: Læger, som udskriver modafinil til en længerevarende periode, skal periodevis reevaluere langtidsbrugen hos patienterne, da langtidseffekten af modafinil ikke er evalueret (> 9 uger).
English: Reproduction toxicity studies revealed no effect on fertility, nor any teratogenic effect, nor any effect on viability, growth or development of the offspring.
Danish: Reproduktionstoksicitetsstudier viste hverken effekt på fertilitet eller teratogen effekt eller effekt på levedygtighed, vækst og udvikling hos afkommet.
English: Blood pressure and heart rate should be regularly monitored in patients receiving modafinil.
Danish: Blodtryk og hjertefrekvens skal monitoreres regelmæssigt hos patienter i modafinilbehandling.
English: The 400 mg dose in study 303 did not lead to higher MWT differences or improved ESS score than the 200 mg dose.
Danish: 400 mgdosen i undersøgelse 303 førte ikke til højere MWT-forskelle eller mere forbedret ESS-score end 200 mg-dosen.
English: Because this type of event is considered to be rare, to have observed cases in a clinical trial setting is unexpected and considered indicative of an incidence higher than previously thought.
Danish: Da denne type hændelse anses for sjælden, er det uventet at have observeret tilfælde i en klinisk undersøgelse, og det tyder på en højere incidens, end man hidtil har troet.
English: The most commonly reported adverse drug reaction is headache, affecting approximately 21% of patients.
Danish: Den almindeligste bivirkning er hovedpine, som er set hos ca. 21 % af patienterne.
English: The percentage of patients experiencing a psychiatric adverse event in clinical trials is also significant, particularly when compared to placebo.
Danish: Procentdelen af patienter, som oplever en psykiatrisk bivirkning i kliniske undersøgelser, er også signifikant, især sammenlignet med placebo.
English: In patients with cirrhosis, the oral clearance of modafinil was decreased by approximately 60%, and the steady-state concentration doubled, compared with values in healthy subjects.
Danish: Hos patienter med cirrose er modafinils orale clearance nedsat med ca. 60 %, og steady-state koncentrationen er fordoblet sammenlignet med værdierne hos raske personer.
English: If the feasibility analysis shows that a scientifically valid, well-designed and suitable powered study is viable, then the MAHs commit to submit a detailed protocol within 2 months and to present the final study report within 6 months of completion of the study.
Danish: Hvis analysen af muligheden for at gennemføre undersøgelsen viser, at en videnskabeligt gyldig, veldesignet undersøgelse med tilstrækkelig statistisk styrke er gennemførlig, har indehaverne af markedsføringstilladelserne påtaget sig at indsende en detaljeret protokol inden for to måneder og fremlægge den endelige undersøgelsesrapport inden seks måneder efter undersøgelsens afslutning.
English: Modafinil promotes wakefulness in a variety of species, including man.
Danish: Modafinil fremmer vågen tilstand hos en række forskellige arter, inklusive mennesket.
English: A search of the MAH's pharmacovigilance database revealed a total of 485 reports related to abuse, misuse, dependency and tolerance associated to modafinil use.
Danish: En søgning i indehaveren af markedsføringstilladelsens lægemiddelovervågningsdatabase viste i alt 485 indberetninger vedrørende misbrug, forkert brug, afhængighed og tolerance i forbindelse med modafinilbrug.
English: In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in paediatric patients (age <17 years); this includes serious rash.
Danish: I kliniske forsøg med modafinil var forekomsten af hududslæt med seponering til følge cirka 0,8% (13 pr. 1.585) hos pædiatriske patienter (alder <17 år); dette inkluderer alvorlige udslæt.
English: In addition modafinil does not address the underlying cause of the obstruction and, in a clinical setting where treatments are expected to be long lasting, the lack of controlled long-term efficacy data is a cause for concern.
Danish: Desuden behandler modafinil ikke den underliggende årsag til obstruktionen, og i en klinisk sammenhæng, hvor behandlinger forventes at være langvarige, giver den manglende kontrol af dataene for langtidsvirkning anledning til betænkeligheder.
English: Fertility No data on fertility are available.
Danish: Fertilitet Der er ingen tilgængelige data om fertilitet.
English: In narcoplesy, however, the benefits of modafinil have been clearly and significantly demonstrated in double blind controlled clinical trials, both in objective and subjective measurements.
Danish: Ved narkolepsi er fordelene ved modafinil dog klart og signifikant påvist i dobbeltblindede kontrollerede kliniske undersøgelser, både i objektive og subjektive målinger.
English: The MAHs will access and submit data on the study on recreational use and diversion among university students in the UK, being developed by the Centre for Public Health, School of Pharmacy and Biomolecular Sciences - Liverpool John Moores University.
Danish: Indehaverne af markedsføringstilladelserne får adgang til og indsender data vedrørende undersøgelsen af fritidsbrug og diversion blandt universitetsstuderende i Storbritannien, som udvikles af Centre for Public Health, School of Pharmacy and Biomolecular Sciences - Liverpool John Moores University.
English: In study 303, 200 mg and 400 mg of Modafinil resulted in increases of MWT of 1.6 and 1.4 minutes, respectively, when compared to baseline.
Danish: I undersøgelse 303 resulterede 200 mg og 400 mg modafinil i stigninger i MWT på henholdsvis 1,6 og 1,4 minutter sammenlignet med baseline.
English: Modafinil containing medicinal products and certain other medicines can affect each other and your doctor may need to adjust the doses that you are taking.
Danish: Modafinil-holdig medicin og visse andre former for medicin kan påvirke hinanden, og det kan derfor være nødvendigt, at din læge justerer doserne.
English: While some of the pre-clinical studies have shown reproductive toxicity, the available human data are insufficient to establish whether toxicity occurs in humans during pregnancy and lactation.
Danish: Nogle af de prækliniske undersøgelser har vist reproduktionstoksicitet, men de tilgængelige humane data er utilstrækkelige til at fastslå, om der forekommer toksicitet hos mennesker under graviditet og amning.
English: Administration of modafinil results in electrophysiological changes indicative of increased alertness and improvements in objective measures of ability to sustain wakefulness.
Danish: Administration af modafinil resulterer i elektrofysiologiske ændringer, som indikerer øget opmærksomhed og forbedringer i objektive mål for evnen til at opretholde årvågenhed.
English: SCIENTIFIC CONCLUSIONS Overall summary of the scientific evaluation of modafinil-containing products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler indeholdende modafinil (se bilag I)
English: • The Committee considered all the available data submitted on the safety and the efficacy of modafinil-containing products.
Danish: • Udvalget vurderede alle de tilgængelige indsendte data om sikkerheden og virkningen af lægemidler indeholdende modafinil.
English: Antidepressants: A number of tricyclic antidepressants and selective serotonin reuptake inhibitors are largely metabolised by CYP2D6.
Danish: Antidepressiva: flere tricykliske antidepressiva og selektive serotonin-reuptake-hæmmere bliver hovedsageligt metaboliseret af CYP2D6.
English: Pharmacotherapeutic group: Psychoanaleptic, centrally acting sympathomimetic, ATC code: N06BA
Danish: Farmakoterapeutisk klassifikation: Psykoanaleptikum, centralt virkende sympatomimetikum, ATCkode: N06BA
English: • Abnormal blood test results showing how your liver is working (increased liver enzymes).
Danish: • Unormale resultater af blodprøver, der viser, hvordan din lever fungerer (øget niveau af leverenzymer).
English: The efficacy in the long term has also not been demonstrated, as the existing long term data is uncontrolled and only subjective parameters were measured.
Danish: Virkningen på langt sigt er heller ikke påvist, da de eksisterende langsigtede data ikke er kontrolleret, og kun subjektive parametre blev målt.
English: While improvement was reported on the number of accidents or near accidents during the commute, no account was taken for the type or duration of the commute and no baseline values were collected.
Danish: Der blev rapporteret om forbedringer i antallet af ulykker eller næsten-ulykker under pendling, men der blev ikke taget højde for typen eller varigheden af pendlingen, og der blev ikke indsamlet baselineværdier.
English: If you forget to take Modafinil containing medicinal products If you forget to take your medicine take the next dose at the usual time, do not take a double dose to make up for the forgotten one.
Danish: Hvis du har glemt at tage modafinil-holdig medicin Hvis du har glemt at tage din medicin, så tag den næste dosis til sædvanlig tid.
English: If you need to take it for a long time your doctor will check regularly that it is still the best medicine for you.
Danish: Hvis du har brug for at tage medicinen i en længere periode, vil din læge jævnligt tjekke, om dette er den bedste medicin for dig,
English: The following adverse reactions have been reported in clinical trials and/or post-marketing experience.
Danish: Nedenstående bivirkninger er rapporteret fra kliniske studier og/eller fra post-marketing erfaring.
English: In a case report, a 50% reduction in ciclosporin concentration was observed in a patient receiving ciclosporin in whom concurrent treatment with modafinil was initiated.
Danish: I et tilfælde blev en reduktion på 50 % af ciclosporin-koncentrationen observeret hos en patient i ciclosporinbehandling, hvor modafinilbehandling blev opstartet.
English: Modafinil containing medicinal products can cause blurred vision or dizziness in up to 1 in 10 people.
Danish: Modafinil-holdig medicin kan forårsage sløret syn eller svimmelhed hos op til 1 ud af 10 personer.
English: Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil.
Danish: Multiorganoverfølsomhedsreaktioner, herunder mindst ét letalt tilfælde efter markedsføring, har optrådt i tæt tidsmæssig relation til påbegyndelse af modafinilbehandling.
English: Modafinil may improve your narcolepsy and reduce the likelihood that you will have sleep attacks but there may still be other ways that you can improve your condition and your doctor will advise you.
Danish: Modafinil kan forbedre din narkolepsi og nedsætte sandsynligheden for, at du vil få søvnanfald, men der kan også være andre måder, hvorpå du kan forbedre din tilstand.
English: In light of this, and because of its known safety profile, the demonstrated benefit is outweighed by the risks.
Danish: I lyset heraf og på grund af modafinils kendte sikkerhedsprofil, vejer risikoen tungere end den påviste fordel.
English: There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil.
Danish: Der er ingen kendte faktorer, som kan forudsige risikoen for eller sværhedsgraden af multiorganoverfølsomhedsreaktioner forbundet med modafinil.
English: Modafinil is well-absorbed with peak plasma concentration reached approximately two to four hours after administration.
Danish: Modafinil absorberes godt, og den maksimale plasmakoncentration nås ca. to til fire timer efter administration.
English: The data from clinical trials in particular raised concerns about the risk of serious skin disorders requiring hospitalization in association with the use of modafinil in children.
Danish: Især dataene fra kliniske undersøgelser gav anledning til betænkeligheder vedrørende risikoen for alvorlige hudlidelser, som krævede hospitalsindlæggelse, i forbindelse med brug af modafinil til børn.
English: • You notice a skin rash or itching (especially if it affects your whole body).
Danish: • Du får hududslæt eller kløe (især hvis det er over hele kroppen).
English: Systemic exposure increases in a dose proportional manner over the range of 200-600 mg.
Danish: Den systemiske eksposition stiger proportionelt med den indgivne dosis i intervallet 200-600 mg.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret medicinen til dig personligt.
English: In addition, following repeat-dose administration of modafinil to children and adolescents, a time-dependent reduction in systemic exposure, which plateaus by approximately week 6 is observed.
Danish: Efter gentagen administration af modafinil til børn og unge ses endvidere en tidsafhængig reduktion i den systemiske eksponering, som når ligevægt efter ca. 6 uger.
English: Your doctor will review your treatment regularly to check that it is right for you.
Danish: Din læge vil jævnligt kontrollere din behandling for at sikre, at den passer til dig.
English: • Have an irregular heartbeat.
Danish: • har uregelmæssig hjerterytme.
English: The outcomes of this study should be: first occurrence of myocardial infarction, cardiovascular death, cardiovascular hospitalisation and all cause mortality.
Danish: Udfaldene af denne undersøgelse skal være: første forekomst af myokardieinfarkt, kardiovaskulært dødsfald, kardiovaskulær hospitalsindlæggelse og generel dødelighed.
English: The MAHs will provide, within 3 months of the Commission Decision, a feasibility analysis of an epidemiological cardiovascular safety study.
Danish: Indehaverne af markedsføringstilladelserne fremsender senest tre måneder efter EuropaKommissionens afgørelse en analyse af muligheden for en epidemiologisk kardiovaskulær sikkerhedsundersøgelse.
English: It is noted during the discussion with the MAH that, in the clinical trials, there was an average blood pressure increase of 2-3 mmHg of systolic blood pressure during the long term extension of pivotal studies.
Danish: Det bemærkes under drøftelse med indehaveren af markedsføringstilladelsen, at der i de kliniske undersøgelser var en gennemsnitlig blodtryksøgning på 2-3 mmHg i det systoliske blodtryk under den langsigtede forlængelse af pivotale undersøgelser.
English: Undesirable effects such as blurred vision or dizziness might also affect ability to drive (see section 4.8).
Danish: Bivirkninger som sløret syn eller svimmelhed kan også påvirke evnen til at føre motorkøretøj (se pkt.
English: Following a request from the MAH, the CHMP convened a Scientific Advisory Group (SAG) CNS during the re-examination procedure.
Danish: Efter en anmodning fra indehaveren af markedsføringstilladelsen indkaldte CHMP en videnskabelig rådgivende gruppe (SAG) CNS under revurderingsproceduren.
English: Adults with severe kidney and liver problems The usual dose is 100 mg a day.
Danish: Voksne med alvorlige nyre- og leverproblemer Den sædvanlige dosis er 100 mg daglig.
English: In addition, there was no significant difference between placebo and modafinil in the percentage of patients who normalise their MSLT scores, which is indicative that a clinically relevant effect has not been established.
Danish: Desuden var der ikke nogen signifikant forskel mellem placebo og modafinil i den procentdel af patienter, som normaliserer deres MSLT-score, hvilket viser, at der ikke er fastslået nogen klinisk signifikant virkning.
English: Positive re-challenge or de-challenge is also reported on a number of cases.
Danish: Positiv geneksponering eller ophør med eksponering er også rapporteret i en række tilfælde.
English: The MAHs will conduct a retrospective drug utilisation study of the use of modafinil in the primary care setting, with data retrieved and analysed at least from the UK General Practice Research Database (GPRD).
Danish: Indehaverne af markedsføringstilladelserne gennemfører en retrospektiv undersøgelse af lægemiddelbrug i primærsektoren med data, der som minimum er indhentet og analyseret fra den britiske General Practice Research Database (GPRD).
English: Detailed grounds for re-examination submitted by the Marketing Authorisation Holder One MAH expressed its disagreement with the CHMP opinion, focusing its grounds for reexamination on the following points:
Danish: De detaljerede begrundelser for revurdering indsendt af indehaveren af markedsføringstilladelsen En indehaver af markedsføringstilladelse udtrykte sin uenighed med CHMP's udtalelse og fokuserede i sine begrundelser for revurdering på følgende punkter:
English: Belgium N.V. Organon Kloosterstraat 6, 5349 AB Oss
Danish: Organon Kloosterstraat 6, 5349 AB Oss
English: Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks).
Danish: Narkolepsi er en sygdom, som medfører usædvanlig stor søvnighed i dagtimerne samt en tendens til pludseligt at falde i søvn i upassende situationer (søvnanfald).
English: In patients deficient in CYP2D6 (approximately 10% of a Caucasian population) a normally ancillary metabolic pathway involving CYP2C19 becomes more important.
Danish: Hos patienter, som mangler CYP2D6 (omkring 10 % af den hvide population), bliver en supplerende metaboliseringsvej, hvor CYP2C19 er involveret, vigtigere.
English: Suicide-related behaviour (including suicide attempts and suicidal ideation) has been reported in patients treated with modafinil.
Danish: Selvmordsrelateret adfærd (inklusive selvmordsforsøg og selvmordstanker) er rapporteret hos patienter i modafinilbehandling.
English: Modafinil is a racemic compound, and the enantiomers have different pharmacokinetics where the elimination t1/2 of the R-isomer is three times that of the S-isomer in adult humans.
Danish: Modafinil er et racemisk blanding, og enantiomererne har forskellig farmakokinetik, hvor eliminationshalveringstiden af R-isomeren er tre gange større end af S-isomeren hos voksne.
English: • This medicine has the potential for you to become reliant (dependent) on it after long-term use.
Danish: • Du kan blive afhængig af denne medicin ved langtidsbrug.
English: You may also have difficulty sleeping, diarrhoea, hallucinations (sensing things that are not real), chest pain, a change in the speed of your heart beat or an increase in blood pressure.
Danish: Du kan også få søvnbesvær, diarré, hallucinationer (fornemme ting, som ikke er virkelige), brystsmerter, ændringer i hjertefrekvensen eller blodtryksforhøjelse.
English: While the data presented by the MAH on abuse, misuse and diversion does not allow a conclusion on the abuse/misuse potential of the product, these results may have been influenced by the fact that relevant populations (such as students) have not have been included.
Danish: De data, som indehaveren af markedsføringstilladelsen har fremlagt vedrørende misbrug, forkert brug og diversion, gør det ikke muligt at drage nogen konklusioner vedrørende potentielt misbrug/forkert brug af lægemidlet, men resultaterne kan have været påvirket af, at de relevante populationer (f.eks. studerende) ikke er inkluderet.
English: Uncontrolled moderate to severe hypertension and in patients with cardiac arrhythmias.
Danish: Ukontrolleret moderat til svær hypertension og hos patienter med hjertearytmi.
English: However, modafinil binds to the norepinephrine transporter and inhibits norepinephrine uptake, but these interactions are weaker than those observed with the dopamine transporter.
Danish: Modafinil binder imidlertid til noradrenalintransporteren og hæmmer noradrenalin-uptake, men disse interaktioner er dog svagere end dem, der er observeret for dopamin- transporteren.
English: In clinical trials, another 3 cases of Serious Cutaneous Adverse Reactions (SCARs) have been observed, which is of particular concern given the rare background incidence rate of such events.
Danish: I kliniske undersøgelser er der observeret yderligere tre tilfælde af alvorlige kutane reaktioner (SCARs), og det er især bekymrende, da baggrundsincidensen for sådanne hændelser er sjælden.
English: Appropriate data on the cardiovascular safety of modafinil in OSA patients continues to be considered necessary to assess the magnitude of the concern.
Danish: Relevante data vedrørende modafinils kardiovaskulære sikkerhed hos OSA-patienter anses fortsat for nødvendige for at vurdere, hvor stor denne betænkelighed er.
English: A causal association between hypersensitivity reactions and modafinil is supported both by postmarketing data and data from clinical trials.
Danish: En kausal forbindelse mellem overfølsomhedsreaktioner og modafinil understøttes både af data efter markedsføring og data fra kliniske undersøgelser.
English: • Changes in blood pressure (high or low), abnormal heart trace (ECG), and irregular or unusually slow heart beat.
Danish: • Ændringer i blodtryk (forhøjet eller nedsat), unormalt ekg (måling af hjertets elektriske aktivitet) og uregelmæssig eller usædvanlig langsom hjerterytme.
English: Maintenance of sleep hygiene
Danish: Vedligeholdelse af god søvnhygiejne