FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take this medicine after the expiry date which is stated on the blister strip and the outer pack after ‘Exp'.
Danish: Brug ikke denne medicin efter den udløbsdato, der står på blisterkortet og den ydre pakning efter ”Exp”.
English: Further consideration will be given to the use of databases in other EU countries, such as the Institute for Drug Outcomes Research (PHARMO) in the Netherlands and Cegedim in France.
Danish: Det vil blive overvejet yderligere at anvende databaser i andre EU-lande, f.eks. Institute for Drug Outcomes Research (PHARMO) i Holland og Cegedim i Frankrig.
English: • Speech problems.
Danish: • Taleproblemer.
English: The key messages have been agreed with CHMP and each Member State will ensure that the relevant information is included in the translation in their National Language, as applicable.
Danish: Nøglebudskaberne er aftalt med CHMP, og hver medlemsstat sørger for, at de relevante oplysninger medtages i oversættelsen til deres nationale sprog.
English: A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline.
Danish: Diagnosen narkolepsi bør stilles i henhold til guideline for International Klassifikation af Søvnlidelser (ICSD2).
English: Take this leaflet and any remaining tablets with you.
Danish: Tag denne indlægsseddel og resten af tabletterne med.
English: These differences, although statistically significant, are very small and therefore its clinical significance is questioned.
Danish: Disse forskelle er statistisk signifikante, men meget små, og derfor sættes der spørgsmålstegn ved den kliniske signifikans.
English: • Diabetes with increased blood sugar.
Danish: • Sukkersyge (diabetes) med forhøjet blodsukker.
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing modafinil.
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende modafinil.
English: This difference in clearance is partially offset by the younger patients' smaller size and lower weight which results in comparable exposure following administration of comparable doses.
Danish: Denne forskel i clearance kompenseres delvist af yngre patienters mindre størrelse og lavere vægt, hvilket resulterer i sammenlignelig eksponering efter administration af sammenlignelige doser.
English: Sleepiness associated with narcolepsy is the only indication approved in all Member States where the product is approved.
Danish: Søvnighed associeret med narkolepsi er den eneste indikation i alle medlemsstater, hvor lægemidlet er godkendt.
English: In study 402, MSLT increased from 7.6 minutes at baseline to 8.6 minutes.
Danish: I undersøgelse 402 steg MSLT fra 7,6 minutter ved baseline til 8,6 minutter.
English: National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De kompetente nationale myndigheder, koordineret af referencemedlemsstaten, hvor dette er relevant, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelserne:
English: Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis.
Danish: Monitorering af patienten og klinisk evaluering af behovet for behandling bør foretages regelmæssigt.
English: Note: This SPC and package leaflet is the version valid at the time of Commission Decision.
Danish: Note: Dette produktresumé og indlægsseddel er den gyldige version på tidspunktet for Kommissionens beslutning.
English: A later review performed by the MHRA revealed additional concerns regarding the benefit-risk balance of some of the indications for which very limited efficacy data exists.
Danish: En senere gennemgang af MHRA viste yderligere betænkeligheder vedrørende risk/benefit-forholdet for nogle af de indikationer, som der er meget begrænsede data for.
English: It is therefore appropriate that treatment with modafinil always starts with the lowest recommended dose (200 mg) and be increased up to 400 mg only in patients with insufficient response.
Danish: Det er derfor hensigtsmæssigt, at behandling med modafinil altid starter med den laveste anbefalede dosis (200 mg) og kun øges op til 400 mg hos patienter med utilstrækkelig respons.
English: As a result, the product information for modafinil was updated across Europe to include strengthened warnings.
Danish: Derfor blev produktinformationen til modafinil opdateret over hele Europa, så den indeholdt yderligere advarsler.
English: Tablets should be swallowed whole.
Danish: Tabletterne bør sluges hele.
English: Tablets should be swallowed whole with water.
Danish: Tabletterne skal sluges hele med vand.
English: This may seem a small absolute increase but in view of the cardiovascular risk associated to this population, and the fact that it is an asymptomatic consequence of treatment, it cannot be dismissed.
Danish: Det kan synes en lille absolut stigning, men i lyset af den kardiovaskulære risiko i denne population og af, at det er en asymptomatisk følge af behandlingen, kan den ikke ignoreres.
English: The benefit-risk balance in this indication is therefore considered to be positive under the normal conditions of use.
Danish: Risk/benefit-forholdet ved denne indikation anses derfor for positivt under normale anvendelsesbetingelser.
English: • Swollen hands and feet.
Danish: • Hævede hænder eller fødder.
English: It should be noted that none of the studies included an objective measurement of sleepiness in the inclusion criteria, which raises additional questions regarding the appropriateness of the population recruited.
Danish: Det skal bemærkes, at ingen af undersøgelserne omfattede en objektiv måling af søvnighed i inklusionskriterierne, og det rejser yderligere spørgsmål med hensyn til, om den korrekte population er rekrutteret.
English: As in the narcolepsy studies, no dose response effect was observed.
Danish: Ligesom i narkolepsiundersøgelsen blev der ikke observeret nogen dosis-respons-virkning.
English: However, there have been reports of modafinil being used as a performance enhancer.
Danish: Der har dog været indberetninger om, at modafinil anvendes som præstationsfremmende middel.
English: This is further illustrated by the fact that patients at the end of the trial were sufficiently sleepy to meet the entrance criteria for the study (MSLT<6 minutes).
Danish: Det illustreres yderligere af, at patienterne ved undersøgelsens afslutning var tilstrækkeligt søvnige til at opfylde inklusionskriterierne for undersøgelsen (MSLT<6 minutter).
English: Modafinil is not considered to be mutagenic or carcinogenic.
Danish: Modafinil anses ikke for at være mutagent eller karcinogent.
English: • Abnormal blood test results showing that the numbers of your white blood cells have changed.
Danish: • Unormale blodprøveresultater, som viser, at antallet af din hvide blodlegemer er forandret.
English: Despite the lack of a clear definition of multi-organ hypersensitivity, reports of allergic reactions involving multiple organs (including a well documented case with a fatal outcome) are of particular concern.
Danish: Til trods for, at der ikke foreligger en klar definition af multiorganoverfølsomhed, giver indberetninger om allergiske reaktioner, der involverer flere organer (herunder et veldokumenteret tilfælde med fatalt udfald) særligt anledning til bekymring.
English: For patients 6 to 7 years of age, the estimated half-life is approximately 7 hours and increases with increase in age until half-life values approach those in adults (approximately 15 hours).
Danish: Hos patienter i alderen 6-7 år er den estimerede halveringstid ca. 7 timer, men stiger med alderen, indtil den nærmer sig halveringstiden hos voksne (ca. 15 timer).
English: The active ingredient in the tablets is modafinil.
Danish: Det aktive stof i tabletterne er modafinil.
English: You may want to consider asking a family member or close friend to help you look out for signs of depression or other changes in your behaviour.
Danish: Du kan overveje at få et familiemedlem eller en nær ven til at hjælpe med at holde øje med faresignalerne for depression eller andre ændringer i din adfærd.
English: Patients should be advised that modafinil is not a replacement for sleep and good sleep hygiene should be maintained.
Danish: Patienterne skal informeres om, at modafinil ikke er en erstatning for søvn, og at god søvnhygiejne skal opretholdes.
English: Temporal association also contributes to the confirmation of causality.
Danish: En tidsmæssig forbindelse bidrager også til at bekræfte kausalitet.
English: In addition, there were reports of suicidal ideation, hostility/aggression and psychotic episodes.
Danish: Desuden var der indberetninger om selvmordstanker, fjendtlighed/aggression og psykotiske episoder.
English: However, in view of the safety concerns identified during this review, risk minimisation measures are considered necessary to ensure a safe and effective use of the product.
Danish: I lyset af de sikkerhedsproblemer, der er identificeret i denne gennemgang, anses risikominimerende foranstaltninger dog for at være nødvendige for sikker og effektiv anvendelse af lægemidlet.
English: After 4 weeks of treatment, subjects in study 402 still presented with MSLT values below the normal (i.e. 10 minutes).
Danish: Efter fire ugers behandling præsenterede personerne i undersøgelse 402 sig stadig med MSLT-værdier under det normale (dvs. 10 minutter).
English: • Have kidney or liver problems (because you will need to take a lower dose).
Danish: • har nyre- eller leverproblemer (du skal tage en lavere dosis).
English: Data presented in support of this indication includes a total of 6 patients, of which at least 2 actually presented with excessive sleepiness due to sleep apnoea.
Danish: De data, der er fremlagt til støtte for denne indikation, omfatter i alt seks patienter, hvoraf mindst to faktisk præsenterede sig med overdreven søvnighed på grund af søvnapnø.
English: Once the Commission Decision is issued, the MAHs must submit an updated version of the Risk Management Plan to the National Competent Authorities, taking into account all recommendations made by the CHMP during the procedure and including all the studies described as conditions of the marketing authorisation.
Danish: Når Kommissionens afgørelse er udstedt, skal indehaverne af markedsføringstilladelserne indsende en opdateret version af risikostyringsplanen til de kompetente nationale myndigheder, idet de tager højde for alle anbefalinger fra CHMP under proceduren og inkluderer alle undersøgelser, der er beskrevet som betingelser for markedsføringstilladelsen.
English: However, the clinical relevance of this increase is questionable as, at the end of the study, the patients would still be characterised as severely ill (severe illness according to ICSD-1 is usually associated to MSLT scores below 5).
Danish: Den kliniske relevans af denne forbedring er dog tvivlsom, da patienterne ved undersøgelsens afslutning stadig ville blive karakteriseret som alvorligt syge (alvorlig sygdom ifølge ICSD-1 associeres normalt med MSLTscorer under 5).
English: Therefore, this SPC and package leaflet may not necessarily represent the current text.
Danish: Dette produktresumé og indlægsseddel repræsenterer derfor ikke nødvendigvis den gældende tekst.
English: Once steady-state is reached, the pharmacokinetic properties of modafinil do not appear to change with continued administration for up to 1 year.
Danish: Når steady-state er nået, synes modafinils farmakokinetiske egenskaber ikke at ændre sig ved fortsat administration i op til et år.
English: Whilst studies with modafinil have demonstrated a potential for dependence, the possibility of dependence with long-term use cannot be entirely excluded.
Danish: Da studier med modafinil har vist en risiko for afhængighed, kan muligheden for afhængighed ved længerevarende brug ikke udelukkes.
English: The chief metabolite (40 - 50% of the dose), modafinil acid, has no pharmacological activity.
Danish: Hovedmetabolitten (40-50% af dosis), modafinilsyre, besidder ingen farmakologisk aktivitet.
English: Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening.
Danish: Selvom der har været et begrænset antal rapporter, kan multiorganoverfølsomhedsreaktioner medføre hospitalsindlæggelse eller være livstruende.
English: • The opinion adopted a Product Information which did not fully reflect the safety information for modafinil
Danish: • Med udtalelsen blev der vedtaget en produktinformation, som ikke fuldt ud afspejlede sikkerhedsoplysningerne for modafinil.
English: Existing long term data are not controlled, are based on a subjective parameter and have failed to demonstrate a significant effect of modafinil.
Danish: Eksisterende langsigtede data er ikke kontrolleret, er baseret på en subjektiv parameter og har ikke kunnet vise en signifikant virkning af modafinil.
English: There are 517 cases of hostility/aggression (4 of which with a fatal outcome), 331 cases of psychosis/psychotic disorders (of which 1 had a fatal outcome), 330 cases of depression and 118 cases of suicide/self-injury (15 with a fatal outcome).
Danish: Der er 517 tilfælde af fjendtlighed/aggression (heraf fire med fatalt udfald), 331 tilfælde af psykose/psykotiske lidelser (heraf ét med fatalt udfald), 330 tilfælde af depression og 118 tilfælde af selvmord/selvskade (15 med fatalt udfald).
English: Your doctor in some cases may decide to increase your daily dose up to 400 mg.
Danish: Din læge kan i nogle tilfælde beslutte at forhøje din dosis til højst 400 mg daglig.
English: • Have any heart problems or high blood pressure.
Danish: • har nogen form for hjerteproblemer eller forhøjet blodtryk.
English: Unknown: delusions
Danish: Ikke kendt: vrangforestillinger
English: Your doctor will only increase your dose (up to the maximum 400 mg a day) provided that you do not have any liver or kidney problems
Danish: Din læge vil kun øge din dosis (til højst 400 mg daglig), hvis du ikke har nogen nyre- eller leverproblemer.
English: The total daily dose may be taken as a single dose in the morning or as two doses in the morning and at noon, according to physician assessment of the patient and the patient's response.
Danish: Den daglige dosis kan tages som en enkelt dosis om morgenen eller som to doser om morgenen og midt på dagen afhængigt af lægens vurdering af patienten og patientens respons.
English: Significant safety issues identified during this review (skin and hypersensitivity reactions, cardiovascular events) require further study.
Danish: De signifikante sikkerhedsproblemer, som er identificeret under denne gennemgang (hud- og overfølsomhedsreaktioner, kardiovaskulære bivirkninger), kræver yderligere undersøgelse.
English: A review of the MAH's pharmacovigilance database identified 873 spontaneous reports of cardiovascular disorders, of which 171 were serious and 17 had a fatal outcome.
Danish: En gennemgang af indehaveren af markedsføringstilladelsens lægemiddelovervågningsdatabase identificerede 873 spontane indberetninger om kardiovaskulære sygdomme, hvoraf 171 var alvorlige, og 17 havde fatalt udfald.
English: Modafinil can be taken by adults who suffer from narcolepsy to help them to stay awake.
Danish: Modafinil kan tages af voksne, som lider af narkolepsi, for at hjælpe dem til at holde sig vågne.
English: Other things to talk to your doctor or pharmacist about
Danish: Andre ting du skal tale med din læge om
English: In fact, no statistically significant difference was noted between the two modafinil doses used (200 and 400 mg) in any of the measurements.
Danish: Faktisk blev der ikke bemærket nogen signifikant forskel mellem de to anvendte modafinildoser (200 og 400 mg) i nogen af målingerne.
English: Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns (see section 4.4).
Danish: Modafinil bør ikke anvendes til børn under 18 år på grund af problemstillinger vedrørende sikkerhed og virkning (se pkt.
English: Idiopathic Hypersomnia
Danish: Idiopatisk hypersomni
English: In the rat peri-post-natal study, modafinil concentration in milk was about 11.5 times higher than in plasma.
Danish: I et rotte peri-post-natalstudie var koncentrationen af modafinil i mælk omkring 11,5 gange højere end i plasma.
English: Hospitalisation and surveillance of psychomotor status; cardiovascular monitoring or surveillance until the patient's symptoms have resolved are recommended.
Danish: Hospitalisering og overvågning af psykomotorisk status; kardiovaskulær monitorering eller overvågning anbefales, indtil symptomerne er forsvundet.
English: - Moderate to severe chronic shift work sleep disorder (SWSD), approved in 10 Member States.
Danish: - Moderat til svær søvnforstyrrelse på grund af skifteholdsarbejde (SWSD), godkendt i 10 medlemsstater.
English: Following consultation with the SAG, the CHMP concluded that the effects on both subjective and objective measures did not provide clear evidence of overall beneficial effect.
Danish: Efter høring af SAG konkluderede CHMP, at virkningerne på både subjektive og objektive mål ikke gav klar dokumentation for den samlede gavnlige virkning.
English: The pharmacokinetic properties of modafinil are linear and time-independent.
Danish: Modafinils farmakokinetiske egenskaber er lineære og tidsafhængige.
English: This circumstance is the result of metabolic auto-induction noted in the pre-clinical studies.
Danish: Denne omstændighed skyldes metabolisk auto-induktion, som er set i de prækliniske studier.
English: The cardiovascular comorbidities in OSA lead to difficulties in interpreting this observation.
Danish: De kardiovaskulære co-morbiditeter i OSA betyder, at det er vanskeligt at tolke denne observation.
English: It is noted that in a number of cases leading to discontinuation there was a very tight temporal association between modafinil and the events, and that in many cases the patients were young and had no known risk factors.
Danish: Det skal bemærkes, at der i en række tilfælde, som førte til seponering, var en tæt tidsmæssig forbindelse mellem modafinil og hændelserne, og at patienterne i mange tilfælde var unge og ikke havde nogen kendte risikofaktorer.
English: Doses of up to 400mg in one or two divided doses can be used in patients with insufficient response to the initial 200mg modafinil dose.
Danish: Doser på op til 400 mg fordelt på én eller to doser kan anvendes hos patienter med utilstrækkeligt respons på den initiale 200 mg modafinildosis.
English: Maintenance of the efficacy in the long term has not been demonstrated, as the existing long term data is uncontrolled.
Danish: Vedligeholdelse af virkningen på langt sigt er ikke påvist, da de eksisterende langsigtede data ikke er kontrolleret.
English: GENESIS PHARMA (CYPRUS) LTD, 2 Amfipoleos, 1st floor, P.O.Box 23638, 2025 Strovolos, Lefkosia, Cyprus
Danish: GENESIS PHARMA (CYPRUS) LTD, 2 Amfipoleos, 1st floor, P.O.Box 23638, 2025 Strovolos, Lefkosia,
English: Tell your doctor straight away if you notice that you are becoming depressed, feel aggressive or hostile towards other people or have suicidal thoughts or other changes in your behaviour (see section 4).
Danish: Fortæl det straks til din læge, hvis du føler dig deprimeret, har aggressive eller fjendtlige tanker om andre mennesker eller oplever selvmordstanker eller andre ændringer i din adfærd (se pkt.
English: Overall, these studies provide proof of the short term efficacy of modafinil in treating excessive daytime sleepiness in patients with narcolepsy.
Danish: Overordnet set beviser disse undersøgelser korttidsvirkningen af modafinil til behandling af overdreven søvnighed om dagen hos patienter med narkolepsi.
English: In addition, the difference between modafinil and placebo was very small (6-10%) for robust differences in MWT.
Danish: Desuden var forskellen mellem modafinil og placebo meget lille (6-10 %) for dokumenterede forskelle i MWT.
English: Excessive sleepiness is defined as difficulty maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations.
Danish: Overdreven træthed er defineret som besvær med opretholdelse af årvågenhed og en øget tendens til at falde i søvn i uhensigtsmæssige situationer.
English: Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur.
Danish: Da multiorganoverfølsomhedhed er variabel i sin udtrykform, kan andre organsystemsymptomer og tegn forekomme.
English: This is usually mild or moderate, dose-dependent and disappears within a few days.
Danish: Hovedpinen opleves normalt som let eller moderat i sværhedsgrad, den er dosisafhængig og forsvinder i løbet af få dage.
English: The study should be started within 2 months of the Commission Decision, and the final report should be submitted within 6 months of study initiation.
Danish: Undersøgelsen skal påbegyndes senest to måneder efter Kommissionens afgørelse, og den endelige rapport skal indsendes senest seks måneder efter undersøgelsens start.
English: Even though the prevalence of idiopathic hypersomnia is thought to be very low (between 1/10 000 and 1/25 000 for IH with long sleep time and between 1/11 000 and 1/100 000 for IH without long sleep time) and the difficulties in conducting large scale trials are acknowledged, no conclusions can be drawn to support the efficacy of the product with such a limited dataset.
Danish: Selvom prævalensen af idiopatisk hypersomni menes at være meget lav (mellem 1/10 000 og 1/25 000 for IH med lang søvntid og mellem 1/11 000 og 1/100 000 for IH uden lang søvntid), og vanskelighederne ved at gennemføre undersøgelser i stor skala anerkendes, kan der ikke drages nogen konklusioner til støtte for lægemidlets virkning med et så begrænset datasæt.
English: - Idiopathic hypersomnia (IH), approved in 4 Member States;
Danish: - Idiopatisk hypersomni (IH), godkendt i fire medlemsstater.
English: • Disrupted sleep or abnormal dreams,
Danish: • Afbrudt søvn eller unormale drømme.
English: The Summary of Product Characteristics should also clearly mention that modafinil is not recommended for use in children and during pregnancy and lactation.
Danish: Produktresuméet skal også tydeligt nævne, at modafinil ikke anbefales til brug hos børn og under graviditet og amning.
English: The MAHs should inform healthcare professionals on the outcome of this review on modafinil via a Direct Healthcare Professional Communication (DHPC) to be distributed the Monday after 5 days have passed from the adoption of the European Commission Decision.
Danish: Indehaverne af markedsføringstilladelserne skal informere lægefaglige personer om resultatet af denne vurdering af modafinil via en direkte meddelelse til fagfolk i sundhedssektoren (Direct Healthcare Professional Communication - DHPC), som skal udsendes mandagen efter, at der er gået 5 dage efter vedtagelsen af Europa-Kommissionens afgørelse.
English: Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders (see section 4.1).
Danish: Behandling bør initieres af eller under supervision af en læge med relevant viden om sygdomme inden for indikationsområdet (se pkt.
English: However, after assessing a subgroup analysis of OSA patients based on possible prognostic factors, the CHMP concluded that it did not allow identification of any specific subgroup where modafinil would have the greatest chance of benefit.
Danish: Efter at have vurderet en undergruppeanalyse af OSA-patienter baseret på mulige prognostiske faktorer konkluderede CHMP imidlertid, at det ikke tillod identifikation af nogen specifik undergruppe, hvor modafinil ville have den største chance for gavnlig virkning.
English: Further information should also be collected on use in pregnancy and lactation, potential for abuse/misuse and diversion and off-label use.
Danish: Der skal også indsamles yderligere oplysninger om brug under graviditet og amning, risiko for misbrug/forkert brug samt diversion og off label-anvendelse.