FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored for signs of phenytoin toxicity, and repeated measurements of phenytoin plasma levels may be appropriate upon initiation or discontinuation of treatment with modafinil.
Danish: Patienterne skal monitoreres for tegn på phenytointoksicitet, og gentagne målinger af plasmakoncentrationen af phenytoin kan være hensigtsmæssigt før påbegyndelse eller ved seponering af modafinilbehandling.
English: Modafinil should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of narcolepsy, has been made in accordance with ICSD diagnostic criteria.
Danish: Modafinil bør kun anvendes til patienter, som har fået en komplet evaluering af deres overdrevne træthed, og til patienter, hvor diagnosen narkolepsi er stillet i henhold til ICSD-diagnosekriterier.
English: Having considered the data presented, it is the Committee's view that modafinil is associated to a rare risk of serious, life-threatening skin reactions.
Danish: Efter at have vurderet de fremlagte data er det udvalgets opfattelse, at modafinil er associeret med en sjælden risiko for alvorlige livstruende hudreaktioner.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMA
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG INDLÆGSSEDDEL FREMLAGT AF EMA
English: Particularly for serious skin disorders, data is indicative of a higher incidence in the paediatric population.
Danish: Især med hensyn til alvorlige hudlidelser tyder dataene på en højere incidens i den pædiatriske population.
English: Like all medicines, Modafinil containing medicinal products can cause side effects, although not everybody gets them.
Danish: Modafinil-holdig medicin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Following the CHMP conclusion and recommendations for modafinil-containing medicinal products, one MAH submitted detailed grounds for the re-examination of the CHMP opinion.
Danish: Efter CHMP's konklusion og anbefalinger for lægemidler indeholdende modafinil indsendte en indehaver af markedsføringstilladelsen detaljerede begrundelser for revurdering af CHMP's udtalelse.
English: The frequency of adverse reactions considered at least possibly related to treatment, in clinical trials involving 1561 patients taking modafinil were as follows: very common (≥1/10), common (≥1/100 to ≤1/10), uncommon (≥1/1000 to ≤1/100), unknown (cannot be estimated from the available data).
Danish: Hyppigheden af bivirkninger, som er fundet i kliniske studier med 1.561 patienter, og som i det mindste kan have en mulig relation til behandlingen med modafinil, er defineret på følgende måde: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The effective elimination half-life of modafinil after multiple doses is about 15 hours.
Danish: Modafinils effektive eliminationshalveringstid efter gentagne doser er ca. 15 timer.
English: While small short-term improvements could be observed in objective sleep measurements, the more pronounced effects were seen in subjective measurements of sleepiness.
Danish: Mens der kunne observeres små kortvarige forbedringer i objektive søvnmålinger, sås der mere udtalte virkninger i subjektive målinger af søvnighed.
English: • Abnormal urine or more frequent urination.
Danish: • Unormal urin eller hyppigere vandladning.
English: Such an evaluation usually consists, in addition to the patient's history, sleep measurements testing in a laboratory setting and exclusion of other possible causes of the observed hypersomnia.
Danish: Ud over patientens sygehistorie består sådan en evaluering normalt af søvnmålinger foretaget i et laboratorium samt eksklusion af andre mulige årsager til hypersomni.
English: The development of skin and hypersensitivity reactions, as well as neuropsychiatric reactions seems to be closely correlated to the modafinil dose.
Danish: Udvikling af hud- og overfølsomhedsreaktioner samt neuropsykiatriske reaktioner synes at hænge nøje sammen med modafinildosen.
English: Because of the newly identified risks of psychiatric and skin reactions in conjunction with cardiovascular risks, but also evidence of significant off label use and concerns about potential abuse, misuse or diversion, a formal review of the full benefit-risk balance of modafinil was initiated by the CHMP through an article 31 referral procedure.
Danish: På grund af de nyidentificerede risici for psykiatriske lidelser og hudreaktioner sammen med kardiovaskulære risici, men også på grund af dokumentation for betydelig off label-anvendelse og betænkeligheder om potentielt forkert brug, misbrug eller diversion, indledte CHMP en formel vurdering af det fulde risk/benefit-forhold for modafinil via en indbringelsesprocedure i henhold til artikel 31.
English: No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil.
Danish: Der er ikke set alvorlige hududslæt i kliniske studier af modafinil hos voksne (0 pr. 4.264).
English: This syndrome may present with ischaemic ECG changes, chest pain or arrhythmia.
Danish: Syndromet kan vise sig ved iskæmiske ekgændringer, brystsmerter eller arytmi.
English: Although statistically significant improvements in sleepiness were noted, the magnitude of effect and response rate to modafinil was small when assessed by objective measurements and limited to a small sub-population of the treated patients.
Danish: Selvom en statistisk signifikant forbedring af søvnigheden blev set, var effekten og responsraten lille, når den blev vurderet ved objektive målinger, og den var begrænset til en lille sub-population af de behandlede patienter.
English: This includes 69 events of torsades de pointes/QT prolongation, 405 of cardiac arrhythmia, 74 of cardiac failure, 205 of hypertension, 462 of cardiomyopathy and 57 of ischemic heart disease.
Danish: Dette omfatter 69 hændelser med torsades de pointes/QT-forlængelse, 405 tilfælde af hjertearytmi, 74 tilfælde af hjertesvigt, 205 tilfælde af hypertension, 462 tilfælde af kardiomyopati og 57 tilfælde af iskæmisk hjertesygdom.
English: Patients with major anxiety should only receive treatment with modafinil in a specialist unit.
Danish: Patienter med svær angst må kun behandles med modafinil på en specialafdeling.
English: Despite the fact that the majority of the spontaneous reports seem to be poorly documented, many included information on de-challenge or re-challenge further supporting a causal role of modafinil in increasing cardiovascular risk.
Danish: Til trods for, at de fleste af de spontane indberetninger synes at være dårligt dokumenteret, indeholdt mange oplysninger om ophør af eksponering eller geneksponering, hvilket yderligere understøtter modafinils kausale rolle i at øge den kardiovaskulære risiko.
English: There are limited data available on the use of modafinil in elderly patients.
Danish: Der er begrænsede data tilgængelige for brug af modafinil hos ældre.
English: • The opinion did not accurately reflect the data supporting the efficacy of Modafinil in the indication excessive sleepiness associated with obstructive sleep apnoea.
Danish: • Udtalelsen afspejler ikke præcist de data, som understøtter modafinils virkning til indikationen overdreven søvnighed associeret med obstruktiv søvnapnø.
English: The MAHs will conduct a pharmacoepidemiological study using large-linked claims databases in the United States to further assess the incidence of Stevens-Johnson syndrome and toxic epidermal necrolysis.
Danish: Indehaverne af markedsføringstilladelserne gennemfører en farmakoepidemiologisk undersøgelse med kombinerede administrative databaser i USA for yderligere at vurdere incidensen af Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
English: While a significant improvement was seen in CGI-C and PVT scores for modafinil treated subjects, these are subjective measures and their validity for use in this specific type of sleep disorder is unclear.
Danish: Der sås en signifikant forbedring i CGI-C- og PVT-scoren for patienter behandlet med modafinil, men disse subjektive målinger og deres gyldighed i forbindelse med denne specifikke type søvnforstyrrelse er uklar.
English: Skin and hypersensitivity reactions
Danish: Hud- og overfølsomhedsreaktioner
English: Severe rashes may cause blistering or peeling of the skin, ulcers in your mouth, eyes, nose or genitals.
Danish: Alvorlige udslæt kan forårsage blæredannelse eller afskalning af huden samt sår i mund, øjne, næse eller kønsdele.
English: The majority of the spontaneous reports reviewed indicated that onset of events was within the first few months of initiating modafinil, and positive de-challenge or re-challenge was also reported.
Danish: De fleste af de spontane indberetninger, som er gennemgået, viste, at debut af bivirkninger skete inden for de første måneder efter initiering af modafinil, og positivt ophør af eksponering eller geneksponering blev også rapporteret.
English: If you take more Modafinil containing medicinal products than you should If you take too many tablets you may feel sick, restless, disorientated, confused or excited.
Danish: Hvis du har taget for meget modafinil-holdig medicin Hvis du tager for mange tabletter, kan du få kvalme eller blive rastløs, desorienteret, konfus eller opstemt.
English: The effects of modafinil on the subjective sleepiness should be interpreted with caution, due to possible unblinding of treatment during the trials because of the neuropsychiatric profile of modafinil.
Danish: Modafinils virkning på den subjektive søvnighed bør tolkes med forsigtighed på grund af mulig afblinding af behandlingen under undersøgelserne som følge af modafinils neuropsykiatriske profil.
English: It is especially important if you are taking any of the following medicines as well as Modafinil containing medicinal products:
Danish: Det er specielt vigtigt, hvis du tager nogle af nedenstående lægemidler samtidig med modafinil-holdig medicin.
English: Diagnosis of sleep disorders
Danish: Diagnosen søvnproblemer
English: However, a higher incidence of cardiovascular adverse events when compared to placebo was observed in the modafinil clinical trials, seems to be consistent across the indications and is not seen exclusively in OSA patients.
Danish: En højere incidens af kardiovaskulære bivirkninger sammenlignet med placebo, som blev observeret i de kliniske undersøgelser med modafinil, synes dog at være konsistent for alle indikationer og ses ikke udelukkende hos OSApatienter.
English: Because safety and effectiveness in controlled studies in children have not been established and because of the risk of serious cutaneous hypersensitivity and psychiatric adverse reactions, the use of modafinil is not recommended
Danish: Da sikkerhed og virkning hos børn ikke er klarlagt i kontrollerede studier, og da der er risiko for alvorlige kutane overfølsomhedsreaktioner og psykiske bivirkninger, bør modafinil ikke anvendes.
English: Steps to ensure good sleep hygiene may include a review of caffeine intake.
Danish: En god søvnhygiejne kan bl.a. sikres ved at evaluere indtaget af koffein.
English: NL-5349 AB Oss
Danish: NL-5349 AB Oss The Netherlands
English: In placebo controlled studies in this indication, 6 patients withdrew from the modafinil group due to a cardiovascular adverse event while only one patient withdrew in the placebo group.
Danish: I placebokontrollerede undersøgelser med denne indikation trådte seks patienter ud af modafinilgruppen på grund af en kardiovaskulær bivirkning, mens kun én patient trådte ud af placebogruppen.
English: Your doctor will monitor your blood clotting times during treatment.
Danish: Din læge vil kontrollere blodets evne til at størkne under behandlingen.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of Modafinil/metabolites in milk (for details see 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at modafinil/metabolitter udskilles i mælk (se pkt.
English: Modafinil may increase its own metabolism via induction of CYP3A4/5 activity but the effect is modest and unlikely to have significant clinical consequences.
Danish: Modafinils metabolisme kan øges via induktion af CYP3A4/5-aktivitet, men effekten er beskeden, og det er ikke sandsynligt, at den har en signifikant klinisk betydning.
English: The SAG considered that amongst OSA patients fully optimised on disease modifying treatment (such as CPAP) and in which all other causes of sleepiness have been treated, only a small subpopulation of patients could potentially benefit from modafinil treatment.
Danish: SAG vurderede, at der blandt de OSA-patienter, som er fuldt optimeret på sygdomsmodificerende behandling (f.eks. CPAP), og hvor alle andre årsager til søvnighed er behandlet, kun er en lille underpopulation af patienter, som kan have gavn af behandling med modafinil.
English: Patients with excessive sleepiness, including those taking modafinil should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.
Danish: Patienter, der lider af overdreven træthed, inklusive de patienter, som tager modafinil, skal have revurderet deres grad af træthed ofte, og hvis det er relevant, skal de rådes til ikke at føre motorkøretøj eller udøve anden farlig aktivitet.
English: Patients using steroidal contraceptives
Danish: Patienter, der bruger hormonelle kontraceptiva
English: • Abnormal periods.
Danish: • Uregelmæssige menstruationer.
English: Prothrombin times should be monitored regularly during the first 2 months of modafinil use and after changes in modafinil dosage.
Danish: Protombintid skal monitoreres regelmæssigt de første to måneder efter initiering af modafinilbehandling og ved efterfølgende ændringer af modafinildosis.
English: In addition, in vitro induction of CYP1A2, CYP2B6 and CYP3A4/5 activities has been observed in human hepatocytes, which were it to occur in vivo, could decrease the blood levels of drugs metabolised by these enzymes, thereby possibly decreasing their therapeutic effectiveness.
Danish: Desuden er in vitro induktion af CYP1A2-, CYP2B6- og CYP3A4/5-aktivitet observeret i humane hepatocytter, som hvis det forekom in vivo kunne nedsætte plasmakoncentrationen af lægemidler, der metaboliseres af disse enzymer, og dermed muligvis nedsætte den terapeutiske effekt.
English: The precise mechanism(s) through which modafinil promotes wakefulness is unknown.
Danish: Den præcise mekanisme, hvormed modafinil fremmer vågen tilstand, er ukendt.
English: A significant number of adverse reactions relating to psychiatric disorders have been reported spontaneously.
Danish: Der er spontant indberettet et signifikant antal bivirkninger med psykiske forstyrrelser.
English: Modafinil- containing medicinal products is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy.
Danish: Lægemidler, som indeholder modafinil, er indiceret til voksne til behandling af overdreven træthed ved narkolepsi med eller uden katapleksi.
English: Modafinil is associated with the onset or worsening of psychotic symptoms or manic symptoms (including hallucinations, delusions, agitation or mania).
Danish: Modafinil er forbundet med opståen eller forværring af psykotiske eller maniske symptomer (inklusive hallucinationer, vrangforestillinger, agitation og mani).
English: Modafinil also does not inhibit the activities of adenylyl cyclase, catechol-O-methyltransferase, glutamic acid decarboxylase MAO-A or B, nitric oxide synthetase, phosphodiesterases II-VI, or tyrosine hydroxylase.
Danish: Modafinil hæmmer heller ikke aktiviteten af adenylylcyklase, catechol-O-metyltransferase, glutaminsyredecarboxylase MAO-A eller B, nitrogenoxid-syntetase, fosfodiesterase II-VI eller tyrosinhydroxylase.
English: The fact that all 3 serious SCARs observed in the modafinil clinical trials have occurred in children is indicative of a higher incidence of these reactions in the paediatric population.
Danish: Alle tre alvorlige SCARs, som er observeret i kliniske undersøgelser af modafinil, er forekommet hos børn, og det tyder på en højere incidens af disse reaktioner i den pædiatriske population.
English: This can be taken once daily (in the morning) or divided into two doses a day (100 mg in the morning and 100 mg at midday).
Danish: Du kan enten tage denne dosis en gang daglig (om morgenen) eller fordelt på to daglige doser (100 mg om morgenen og 100 mg midt på dagen).
English: One MAH has implemented a pregnancy registry in the United States to systematically collect data on the effect of modafinil exposure in women of childbearing potential during pregnancy, labour and delivery.
Danish: En indehaver af markedsføringstilladelse har indført et graviditetsregister i USA for systematisk at indsamle data vedrørende virkningen af modafinileksponering hos kvinder i den fertile alder under graviditet, fødselsveer og fødsel.
English: NAME OF THE MEDICINAL PRODUCT Modafinil - containing medicinal products (see Annex I) products 100 mg tablets Modafinil - containing medicinal products (see Annex I) products 200 mg tablets See Annex I - To be completed nationally.
Danish: Modafinilholdige lægemidler (se bilag I) lægemiddel 100 mg tabletter Modafinilholdige lægemidler (se bilag I) lægemiddel 200 mg tabletter Se bilag 1 - udfyldes nationalt
English: A fatal outcome was reported in 3 cases (cardiomyopathy, cardiac failure and syncope).
Danish: Der er indberetninger om fatalt udfald i tre tilfælde (kardiomyopati, hjertesvigt og synkope).
English: Higher concentrations of one of the circulating metabolites, modafinil sulfone, are present in children and adolescents as compared to adults.
Danish: En af de cirkulerende metabolitter, modafinilsulfon, findes i højere koncentrationer hos børn og unge end hos voksne.
English: In clinical trials, the most commonly reported events leading to study discontinuation were insomnia, anxiety, depression and agitation.
Danish: I kliniske undersøgelser var de hyppigst indberettede bivirkninger, som førte til udtræden af undersøgelsen, insomni, angst, depression og agitation.
English: Induced emesis or gastric lavage should be considered.
Danish: Provokeret opkastning eller ventrikelskylning skal overvejes.
English: In non-clinical models, equal wakefulness-promoting doses of methylphenidate and amphetamine increase neuronal activation throughout the brain, whereas modafinil unlike classical psychomotor stimulants, predominantly affects brain regions implicated in regulating arousal, sleep, wake and vigilance.
Danish: I prækliniske modeller øger ækvivalente årvågenhedsfremmende doser af methylphenidat og amphetamin den neuronale aktivitet i hele hjernen, mens modafinil derimod i modsætning til de klassiske psykomotoriske stimulanter hovedsageligt påvirker hjerneområder, der er involveret i regulering af ophidselse, søvn, årvågenhed og søvnløshed.
English: This type of events was also observed in clinical trials, and frequently time to onset was suggestive of a temporal association with the product.
Danish: Denne type bivirkning er også observeret i kliniske undersøgelser, og ofte tydede tiden til symptomdebut på en tidsmæssig forbindelse med lægemidlet.
English: • High blood cholesterol.
Danish: • Forhøjet kolesterolniveau i blodet.
English: The MAHs will continue to perform surveillance of severe skin reactions in the German Severe Cutaneous Adverse Reactions (SCAR) registry.
Danish: Indehaverne af markedsføringstilladelserne udfører fortsat overvågning af alvorlige hudreaktioner i det tyske register for alvorlige hudreaktioner (SCAR).
English: In this assessment of the benefit-risk profile of modafinil in its different indications, the CHMP reviewed available data from pre-clinical and clinical studies, spontaneous reports, published literature and other data submitted by the MAHs as relevant.
Danish: I denne vurdering af modafinils risk/benefit-profil ved de forskellige indikationer gennemgik CHMP de tilgængelige data fra prækliniske og kliniske undersøgelser, spontane rapporter, publiceret litteratur og andre relevante data, som indehaveren af markedsføringstilladelsen havde indsendt.
English: Reproductive toxicity studies conducted in rats and rabbits showed an increased incidence in skeletal variations (changes in the numbers of ribs and delayed ossification), embryo-fetal lethality (periimplantation loss and resorptions) and some evidence of an increase in stillbirths (rats only), in the absence of maternal toxicity, at clinically relevant exposures.
Danish: Reproduktionstoksicitetsstudier udført i rotter og kaniner viste en øget forekomst af skeletale forandringer (ændringer i antallet af ribben og forsinket ossifikation), embryo-føtal dødelighed (periimplantationstab og resorption) og en vis evidens for et øget antal dødfødsler (kun rotter) uden maternel toksicitet ved en klinisk relevant eksponering.
English: In study 305 (a phase 3 randomised, double-blind, placebo-controlled study), a modest but statistically significant improvement was observed in the MSLT score.
Danish: I undersøgelse 305 (fase 3-, randomiseret, dobbeltblindet placebokontrolleret undersøgelse) sås der en beskeden, men statistisk signifikant, forbedring i MSLT-scoren.
English: As modafinil may inhibit CYP2C19, lower doses of antidepressants may be required in such patients.
Danish: Da modafinil kan hæmme CYP2C19, kan det være nødvendigt at nedsætte dosis af antidepressivum hos disse patienter.
English: - Obstructive Sleep Apnoea (OSA), approved in 11 Member States;
Danish: - Obstruktiv søvnapnø (OSA), godkendt i 11 medlemsstater.
English: Modafinil does not appear to be a direct 1-adrenoceptor agonist.
Danish: Modafinil er ikke en direkte α1-receptoragonist.
English: • The Committee considered that there are significant risks associated to modafinil use, including risk of serious cardiovascular disorders, neuropsychiatric disorders and skin and hypersensitivity disorders.
Danish: • Udvalget vurderede, at der er signifikante risici forbundet med anvendelse af modafinil, herunder risiko for alvorlige kardiovaskulære sygdomme, neuropsykiatriske sygdomme og hud- og overfølsomhedslidelser.
English: Pregnancy There is limited data on the use of modafinil in pregnant women.
Danish: Graviditet Der er utilstrækkelige data fra anvendelse af modafinil til gravide kvinder.
English: • Abnormal vision or dry eyes.
Danish: • Synsforstyrrelser eller tørre øjne.
English: Multi-organ hypersensitivity reaction
Danish: Multiorganoverfølsomhedsreaktion
English: Animal exposure to modafinil, based on actual plasma levels in the general toxicology, reproductive and carcinogenicity studies, was less than or similar to that expected in humans.
Danish: Modafinileksponering hos dyr, baseret på aktuelle plasmaniveauer i generelle toksikologi-, reproduktions- og karcinogenicitetstudier, var mindre eller tilsvarende den, der forventes hos mennesker.
English: Results from clinical interaction studies suggest that the largest effects may be on substrates of CYP3A4/5 that undergo significant presystemic elimination, particularly via CYP3A enzymes in the gastrointestinal tract.
Danish: Resultater fra kliniske interaktionsstudier antyder, at den største effekt kan være på CYP3A4/5-substrater, som undergår en signifikant præsystemisk elimination, især via CYP3A4-enzymer i mavetarmkanalen.
English: In particular, the MAH discussed in their detailed grounds: o the clinical relevance of the differences observed on objective measures of wakefulness o whether the entry criteria of the studies were appropriate o the lack of supportive evidence of possible unblinding o the benefit for a specific subpopulation of patients
Danish: Indehaveren af markedsføringstilladelsen diskuterede især i sine detaljerede begrundelser: o den kliniske relevans af de observerede forskelle i objektive mål for vågenhed o om inklusionskriterierne for disse undersøgelser var korrekte o manglen på støttende dokumentation for mulig afblinding o den gavnlige virkning for en specifik underpopulation af patienter