FrancophonIA/ELRC3.0 huggingface dataset:
English: Reproductive system and breast disorders Uncommon: menstrual disorder
Danish: Det reproduktive system og mammae Ikke almindelig: menstruationsforstyrrelser
English: The wake-promoting effects of modafinil are antagonised by D1/D2 receptor antagonists suggesting that it has indirect agonist activity.
Danish: Årvågenhedseffekten af modafinil antagoniseres af D1/D2-receptorantagonister, hvilket indikerer, at modafinil har en indirekte agonistaktivitet.
English: A total of 16 cases of Stevens Johnson Syndrome/Toxic Epidermal Necrolysis/Erythema Multiforme have been reported in a post-marketing setting.
Danish: Der er indberetninger om i alt 16 tilfælde af Stevens-Johnsons syndrom/toksisk epidermal nekrolyse/erythema multiforme efter markedsføring.
English: Caution should be exercised in administering modafinil to patients with history of alcohol, drug or illicit substance abuse.
Danish: Der skal udvises forsigtighed, når modafinil administreres til patienter, som tidligere har haft et misbrug af alkohol, lægemidler eller illegale stoffer.
English: Potential risk of abuse, misuse and diversion
Danish: Potentiel risiko for misbrug, forkert brug og diversion
English: In 2007, concerns relating to serious psychiatric disorders (suicidal thoughts/behaviour, symptoms of psychosis and mania) and serious skin and subcutaneous tissue disorders (including erythema multiforme and Stevens-Johnson syndrome) prompted a review of the available data from clinical trials and spontaneous adverse reaction reports by the Pharmacovigilance Working Party (PhVWP).
Danish: I 2007 gav betænkeligheder i forhold til alvorlige psykiatriske lidelser (selvmordstanker/-adfærd, symptomer på psykose og mani) og alvorlige lidelser i hud og subkutane væv (herunder erythema multiforme og Stevens-Johnsons syndrom) anledning til en gennemgang af de tilgængelige data fra kliniske undersøgelser og spontane indberetninger om bivirkninger i arbejdsgruppen vedrørende lægemiddelovervågning (Pharmacovigilance Working Party - PhVWP).
English: • Some people have reported having suicidal or aggressive thoughts or behaviour while taking this medicine.
Danish: • Nogen patienter har rapporteret selvmordstanker, aggressive tanker samt selvmordsrelateret adfærd under behandlingen med denne medicin.
English: • Medicines for epilepsy (e.g. carbamazepine, phenobarbital or phenytoin).
Danish: • Medicin mod epilepsi (f.eks. carbamezepin, phenobarbital eller phenytoin).
English: Modafinil tablets are not recommended in patients with a history of left ventricular hypertrophy or cor pulmonale and in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants.
Danish: Modafinil bør ikke anvendes til patienter, som har en anamnese med venstre ventrikelhypertrofi eller cor pulmonale, og til patienter med mitralprolaps, som har oplevet mitralprolaps-syndromet ved tidligere behandling med CNS-stimulerende stoffer.
English: In the placebo controlled studies, various cardiovascular events occurred almost exclusively in the modafinil treated group.
Danish: I de placebokontrollerede undersøgelser forekom forskellige kardiovaskulære bivirkninger næsten udelukkende i gruppen, der blev behandlet med modafinil.
English: Patients with abnormal levels of sleepiness who take modafinil should be advised that their level of wakefulness may not return to normal.
Danish: Patienter med et unormalt træthedsniveau, som anvender modafinil, skal gøres opmærksomme på, at deres niveau af vågen tilstand ikke nødvendigvis bliver normalt.
English: • Weakness.
Danish: • Svækkelse.
English: In the two phase 3 randomised, double blind, placebo-controlled, multicenter studies presented, results obtained with both objective efficacy measures used were consistent and demonstrated statistically significant benefits of modafinil when compared to placebo.
Danish: I de to fase 3-, randomiserede, dobbeltblindede, placebokontrollerede multicenterundersøgelser var de resultater, der blev opnået for begge de anvendte objektive effektmål, konsistente og viste statistisk signifikante fordele ved modafinil sammenlignet med placebo.
English: Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively,
Danish: Tegn og symptomer på denne bivirkning var forskellige; dog havde patienterne typisk, men ikke udelukkende, feber og udslæt i forbindelse med anden organpåvirkning.
English: In clinical trials, all the hypersensitivity related terms were reported more commonly in association to modafinil than to placebo.
Danish: I kliniske undersøgelser er alle overfølsomhedsrelaterede reaktioner rapporteret hyppigere i forbindelse med modafinil end med placebo.
English: Sexually active women of child-bearing potential should be established on a contraceptive programme before taking modafinil.
Danish: Seksuelt aktive kvinder i den fødedygtige alder skal have fastlagt en svangerskabsforebyggende metode før anvendelse af modafinil.
English: Uncommon: hypercholesterolaemia, hyperglycaemia, diabetes mellitus, increased appetite,
Danish: Ikke almindelig: hyperkolesterolæmi, hyperglykæmi, diabetes mellitus, øget appetit
English: While modafinil is not currently approved for paediatric use, a number of serious adverse reactions have been reported in children.
Danish: Selvom modafinil på nuværende tidspunkt ikke er godkendt til børn og unge, er der indberetninger om en række alvorlige bivirkninger hos børn.
English: An ECG is recommended in all patients before Modafinil treatment is initiated.
Danish: Det anbefales tage ekg på patienten, før behandling med modafinil startes.
English: • Ciclosporin (used to prevent organ transplant rejection, or for arthritis or psoriasis).
Danish: • Ciclosporin (til forebyggelse af afstødning af organer efter transplantation samt til behandling af leddegigt eller psoriasis).
English: The dosage of modafinil should be reduced by half in patients with severe hepatic impairment.
Danish: Dosis af modafinil skal halveres hos patienter med svært nedsat leverfunktion.
English: Czech Republic Torrex Chiesi CZ, s.r.o.
Danish: Torrex Chiesi CZ, s.r.o.
English: Modafinil is associated with the onset or worsening of anxiety.
Danish: Modafinil er forbundet med opståen eller forværring af angst.
English: Anticonvulsants: Co-administration of potent inducers of CYP activity, such as carbamazepine and phenobarbital, could reduce the plasma levels of modafinil.
Danish: Antikonvulsiva: samtidig administration af potente CYP-induktorer, såsom carbamazapin og phenobarbital, kan nedsætte plasmakoncentrationen af modafinil.
English: Other medicinal products: Substances that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol and omeprazole may have reduced clearance upon co-administration of modafinil and may thus require dosage reduction.
Danish: Andre lægemidler: stoffer, som hovedsageligt elimineres via CYP2C19-metabolisme, som diazepam, propanolol og omeprazol, kan have reduceret clearance ved samtidig administration af modafinil, hvorfor dosisreduktion kan være nødvendig.
English: • Antiviral medicines to treat HIV infection (protease inhibitors e.g. indinavir or ritonavir).
Danish: • Antiviral medicin til behandling af hiv-infektion (proteasehæmmere f.eks. indinavir eller ritonavir).
English: Talk to your doctor about the birth control methods that will be right for you while you are taking Modafinil containing medicinal products (and for two months after stopping) or if you have any other concerns.
Danish: Tal med lægen om velegnede præventionsmetoder, mens du tager modafinil-holdig medicin (og to måneder efter, behandlingen er ophørt), eller hvis du er i tvivl om noget.
English: • Calcium channel blockers or beta-blockers for high blood pressure or heart problems (e.g. amlodipine, verapamil or propranalol).
Danish: • Calciumantagonister eller betablokkere, som bruges til behandling af for højt blodtryk eller hjerteproblemer (f.eks. amlodipin, verapamil eller propranolol).
English: Adequate contraception will require continuation of these methods for two months after stopping modafinil.
Danish: For at opnå tilstrækkelig beskyttelse skal patienten fortsætte med disse metoder i to måneder efter seponering af modafinil.
English: Steroidal contraceptives: The effectiveness of steroidal contraceptives may be impaired due to induction of CYP3A4/5 by modafinil.
Danish: Hormonelle kontraceptiva: effektiviteten af hormonelle kontraceptiva kan være nedsat på grund af modafinils induktion af CYP3A4/5.
English: Examples include ciclosporin, HIV-protease inhibitors, buspirone, triazolam, midazolam and most of the calcium channel blockers and statins.
Danish: hiv-proteasehæmmere, buspiron, triazolam, midazolam samt de fleste calciumantagonister og statiner.
English: In non-clinical models, modafinil has weak to negligible interactions with receptors involved in the regulation of sleep/wake states (e.g., adenosine, benzodiazepine, dopamine, GABA, histamine, melatonin, norepinephrine, orexin, and serotonin).
Danish: I prækliniske modeller har modafinil svage til ubetydelige interaktioner med receptorer, der er involveret i regulering af den sovende/vågne tilstand (f.eks. adenosin, benzodiazepin, dopamin, GABA, histamin, melatonin, noradrenalin, orexin og serotonin).
English: It is therefore recommended that the Summary of Product Characteristics be updated to reflect the skin, hypersensitivity, neuropsychiatric and cardiovascular adverse reactions observed.
Danish: Det anbefales derfor, at produktresuméet opdateres for at afspejle de observerede hud- og overfølsomhedsbivirkninger samt neuropsykiatriske og kardiovaskulære bivirkninger.
English: Although modafinil-induced wakefulness can be attenuated by the 1-adrenoceptor antagonist, prazosin, in other assay systems (e.g. vas deferens) responsive to -adrenoceptor agonists, modafinil is inactive.
Danish: Selvom modafinil-induceret årvågenhed kan svækkes af α1-receptorantagonisten prazosin, er modafinil inaktiv i andre assay-systemer (f.eks. ductus deferens), som reagerer på α-receptoragonister.
English: This included serious cases of moderate chest pain linked to symptomatic mitral valve prolapse, increased heart rate, congestive heart failure, cardiomegaly, palpitations, syncope and bradycardia.
Danish: Dette omfattede alvorlige tilfælde af moderate brystsmerter knyttet til symptomatisk mitralklapproplas, øget hjertefrekvens, kongestiv hjerteinsufficiens, kardiomegali, palpitationer, synkope og bradykardi.
English: Caution should be exercised in giving modafinil to patients with a history of psychiatric disorders including psychosis, depression , mania, major anxiety, agitation, insomnia or substance abuse (see below).
Danish: Der skal udvises forsigtighed ved anvendelse af modafinil til patienter, der har en anamnese med psykiske sygdomme herunder psykoser, depression, mani, svær angst, agitation, insomni eller stofmisbrug (se nedenfor).
English: Severe chronic renal failure (creatinine clearance up to 20 mL/min) did not significantly affect the pharmacokinetics of modafinil administered at 200 mg, but exposure to modafinil acid was increased 9-fold.
Danish: Svær, kronisk nyrefunktionsnedsættelse (creatinin-clearance op til 20 ml/min) påvirkede ikke signifikant modafinils farmakokinetik ved en dosis på 200 mg.
English: Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht The Netherlands
Danish: Computerweg 10, 3542 DR Utrecht The Netherlands
English: Furthermore, it was noted that differences likely to be clinically significant in objective measures of sleepiness between modafinil and placebo were limited to a very small percentage of the patient population in the modafinil clinical trials.
Danish: Desuden blev det bemærket, at forskelle mellem modafinil og placebo, som med sandsynlighed ville være klinisk signifikante i objektive målinger af søvnighed, var begrænset til en meget lille procentdel af patientpopulationen i de kliniske modafinilundersøgelser.
English: • Have ever had depression, low mood, anxiety, psychosis (loss of contact with reality) or mania (over-excitement or feeling of extreme happiness) or bipolar disorder because Modafinil containing medicinal products may make your condition worse.
Danish: • har eller har haft depression, nedsat sindsstemning, angst, psykose (tab af virkelighedssans), mani (overdreven opstemthed eller ekstrem glædesfølelse) eller maniodepressivitet (bipolær sindslidelse), da modafinil kan forværre disse tilstande.
English: Isolated cases have also been reported after prolonged treatment (e.g., 3 months).
Danish: Der er ligeledes set enkelte tilfælde af hududslæt efter længerevarende behandling (fx 3 måneder).
English: As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required (see section 4.5).
Danish: Da modafinil kan nedsætte effektiviteten af orale kontraceptiva, er alternative, supplerende former for prævention nødvendig (se pkt.
English: The efficacy of modafinil in patients with obstructive sleep apnoea (OSA) exhibiting excessive day time sleepiness despite treatment with continuous positive airways pressure (CPAP) has been studied in short term randomised controlled clinical trials.
Danish: Modafinils virkning hos patienter med obstruktiv søvnapnø (OSA), som oplever overdreven søvnighed om dagen, selvom de behandles med kontinuerligt positivt sluteksspirationstryk (PEEP), er blevet undersøgt i korttids, randomiserede, kontrollerede kliniske forsøg.
English: In view of the potential for lower clearance and increased systemic exposure, it is recommended that patients over 65 years of age commence therapy at 100 mg daily.
Danish: Da ældre generelt har nedsat clearance og øget systemisk eksponering, bør behandling påbegyndes ved 100 mg dagligt hos patienter over 65 år.
English: This can be taken once daily (in the morning) or divided into two doses a day (50 mg in the morning and 50 mg at midday).
Danish: Denne dosis kan tages enten en gang daglig (morgen) eller fordelt på to daglige doser (50 mg morgen og 50 mg middag).
English: Blood and lymphatic system disorders Uncommon: eosinophilia, leucopenia
Danish: Blod og lymfesystem Ikke almindelig: eosinofili, leukopeni
English: • The Committee therefore considered that the benefit risk balance: Is positive under normal conditions of use for excessive sleepiness associated to narcolepsy Is not positive under normal conditions of use for excessive sleepiness associated to obstructive sleep apnoea
Danish: • Udvalget mente derfor, at risk/benefit-forholdet: er positivt under normale anvendelsesbetingelser for overdreven søvnighed associeret med narkolepsi ikke er positivt under normale anvendelsesbetingelser for overdreven søvnighed associeret med obstruktiv søvnapnø ikke er positivt under normale anvendelsesbetingelser for overdreven søvnighed associeret med søvnforstyrrelser i forbindelse med skifteholdsarbejde ikke er positivt under normale anvendelsesbetingelser for overdreven søvnighed associeret med idiopatisk hypersomni.
English: Important information about some of the ingredients of Modafinil containing medicinal products [To be completed nationally].
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i modafinil-holdig medicin [Udfyldes nationalt]
English: • Sleepiness, extreme tiredness or difficulty sleeping (insomnia)
Danish: • Søvnighed, ekstrem træthed eller søvnløshed.
English: • Medicines for thinning the blood (e.g. warfarin).
Danish: • Blodfortyndende medicin (f.eks. warfarin).
English: Modafinil should not be used during breast feeding.
Danish: Modafinil bør ikke anvendes under amning.
English: Symptoms most often accompanying modafinil overdose, alone or in combination with other drugs have included: insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhoea; and cardiovascular changes such as tachycardia, bradycardia, hypertension and chest pain.
Danish: De almindeligste symptomer set i forbindelse med overdosering af modafinil alene eller i kombination med andre lægemidler inkluderer: Søvnløshed, symptomer fra centralnervesystemet som rastløshed, desorientering, konfusion, eksitation og hallucinationer, fordøjelsesproblemer som kvalme og diarré samt kardiovaskulære ændringer som takykardi, bradykardi, hypertension og brystsmerter.
English: Common: tachycardia, palpitation Uncommon: extrasystoles, arrhythmia, bradycardia
Danish: Almindelig: takykardi, palpitationer Ikke almindelig: ekstrasystoler, arytmi, bradykardi
English: Updates on data from the registry will be presented in future modafinil PSURs.
Danish: Opdateringer af data fra registeret fremlægges i fremtidige PSUR'er for modafinil.
English: In humans, modafinil restores and/or improves the level and duration of wakefulness and daytime alertness in a dose-related manner.
Danish: Hos mennesker genopretter og/eller øger modafinil opmærksomhedsfunktionen og omfanget af normal vågentilstand i dagtimerne, afhængigt af den indgivne dosis.
English: Common: blurred vision Uncommon: abnormal vision, dry eye
Danish: Almindelig: sløret syn Ikke almindelig: unormalt syn, tørre øjne
English: • Medicines for depression (e.g. amitriptyline, citalopram or fluoxetine) or anxiety (e.g. diazepam).
Danish: • Medicin mod depression (f.eks. amitriptylin, citalopram eller fluoxetin) eller angst (f.eks. diazepam).
English: • Difficulty moving muscles smoothly or other movement problems, muscle tension, coordination problems.
Danish: • Problemer med at bevæge musklerne jævnt eller andre bevægelsesproblemer,
English: Updates on data from the study should be presented in future modafinil PSURs.
Danish: Opdateringer af data fra undersøgelsen skal fremlægges i fremtidige PSUR'er for modafinil.
English: Modafinil should be discontinued at the first sign of rash and not restarted (see section 4.8).
Danish: Modafinil bør seponeres ved det første tegn på udslæt, og behandlingen bør ikke genoptages (se pkt.
English: • Have had alcohol or drug problems in the past.
Danish: • har misbrugt alkohol eller lægemidler/stoffer
English: Common side effects (affecting fewer than 1 in 10 people):
Danish: Almindelige bivirkninger (påvirker mindre end 1 ud af 10 brugere):
English: If psychiatric symptoms develop in association with modafinil treatment, modafinil should be discontinued and not restarted.
Danish: Hvis psykiske symptomer opstår i forbindelse med modafinilbehandling, skal modafinil seponeres, og behandlingen bør ikke genoptages.
English: Common: vasodilatation Uncommon: hypertension, hypotension
Danish: Vaskulære sygdomme Almindelig: vasodilation Ikke almindelig: hypertension, hypotension
English: Renal and urinary disorders Uncommon: abnormal urine, urinary frequency
Danish: Nyrer og urinveje Ikke almindelig: unormal urin og urineringsfrekvens
English: Modafinil is moderately bound to plasma protein (approximately 60%), primarily to albumin, which indicates that there is a low risk of interaction with strongly bound drugs.
Danish: Modafinil er bundet moderat til plasmaprotein (ca. 60 %), især til albumin.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: 6.6 Regler for destruktion <og anden håndtering> Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Your doctor will need to check these regularly while you are taking Modafinil containing medicinal products.
Danish: Din læge vil jævnligt tjekke disse tilstande under behandlingen med modafinil-holdig medicin.
English: Care should be taken in using modafinil in patients with co-morbid bipolar disorder because of concern for possible precipitation of a mixed/manic episode in such patients.
Danish: Modafinil skal anvendes med forsigtighed til patienter med samtidig bipolar lidelse på grund af mulig fremprovokering af en blandet/manisk episode hos disse patienter.
English: Marketing Authorisation Holder and manufacturers [See Annex I - To be completed nationally]
Danish: Indehaver af markedsføringstilladelsen og fremstiller [Se bilag I - Udfyldes nationalt]
English: Cardiovascular adverse events such as hypertension and arrhytmias are documented in association with modafinil.
Danish: Der er dokumenteret kardiovaskulære bivirkninger som hypertension og arytmier i forbindelse med modafinil.
English: Food has no effect on overall modafinil bioavailability; however, absorption (tmax) may be delayed by approximately one hour if taken with food.
Danish: Absorptionen (tmax) kan dog blive forhalet med ca. en time, hvis modafinil tages i forbindelse med et måltid.
English: The higher rate of adverse events observed in the modafinil group during the OSA trials is of particular concern, given the known cardiovascular risks in this population.
Danish: Den højere forekomst af bivirkninger i modafinilgruppen i OSA-undersøgelsen er særligt bekymrende med de kendte kardiovaskulære risici i denne population.
English: The recommended starting daily dose is 200 mg.
Danish: Den anbefalede startdosis er 200 mg dagligt.
English: The usual dose is 100 mg a day.
Danish: Den sædvanlige dosis er 100 mg daglig.
English: Patients will abnormal findings should receive further specialist evaluation and treatment before Modafinil treatment is considered.
Danish: Patienter med unormale fund skal evalueres yderligere af en specialist, før behandling med modafinil kan overvejes.
English: Cardiovascular risks
Danish: Kardiovaskulær risiko
English: Common: abnormal liver function tests, dose related increases in alkaline phosphatase and gamma glutamyl transferase have been observed.
Danish: Almindelig: unormale leverfunktionstest, en dosisafhængig stigning af basisk fosfatase og gammaglutamyltransferase er set.
English: Abuse, misuse and diversion
Danish: Misbrug, forkert brug og diversion
English: • Hormonal contraceptives (including the contraceptive pill, implants, intrauterine devices (IUDs) and patches).
Danish: • Hormonelle præventionsmidler (inklusiv p-piller, implantater, spiraler og plastre).
English: Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Danish: Brug af anden medicin Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Other associated manifestations included myocarditis, hepatitis, liver function test abnormalities, haematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia.
Danish: Andre associerede symptomer inkluderede myokarditis, hepatitis, unormale leverfunktionsprøver, hæmatologiske abnormiteter (f.eks. eosinofili, leukopeni, trombocytopeni), pruritus og asteni.
English: You will need to consider other birth control methods while taking Modafinil containing medicinal products, and for two months after stopping treatment, because Modafinil containing medicinal products reduces their effectiveness.
Danish: Du skal overveje at bruge andre præventionsmetoder under behandlingen med modafinil-holdig medicin og i 2 måneder efter endt behandling, da modafinil nedsætter effektiviteten af hormonelle præventionsmidler.
English: In the two phase 3 randomised, double blind, placebo-controlled, multicenter studies presented, modest improvement was seen in the objective parameters measured.
Danish: I de to forelagte fase 3-, randomiserede, dobbeltblindede placebokontrollerede multicenterundersøgelser sås der en beskeden forbedring i de objektive målte parametre.
English: Due to a possible inhibition of CYP2C19 by modafinil and suppression of CYP2C9 the clearance of phenytoin may be decreased when modafinil is administered concomitantly.
Danish: På grund af modafinils mulige hæmning af CYP2C19 og suppression af CYP2C9 kan clearance af phenytoin nedsættes ved samtidig administration af modafinil.
English: • Excess wind, reflux (bringing back fluid from the stomach), increased appetite, weight changes, thirst or taste alteration.
Danish: • Luft i maven, sure opstød, øget appetit, vægtændringer, tørst eller smagsændringer.