FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee considered that the evidence for clinically significant efficacy of modafinil-containing products in excessive sleepiness associated with obstructive sleep disorder, shift work sleep disorder and idiopathic hypersomnia is very limited, and therefore any potential benefit for patients is outweighed by the identified risks.
Danish: Udvalget var af den opfattelse, at dokumentationen for en klinisk signifikant virkning af lægemidler indeholdende modafinil ved overdreven søvnighed associeret med obstruktiv søvnforstyrrelse, søvnforstyrrelser på grund af skifteholdsarbejde og idiopatisk hypersomni er meget begrænset, og den potentielt gavnlige virkning for patienterne opvejes derfor af de identificerede risici.
English: • Migraine.
Danish: • Brystsmerter.
English: • The Committee considered that the evidence for clinically significant efficacy of modafinilcontaining products in excessive sleepiness associated with obstructive sleep disorder, shift work sleep disorder and idiopathic hypersomnia is very limited, and therefore any potential benefit for patients is outweighed by the identified risks.
Danish: • Udvalget var af den opfattelse, at dokumentationen for klinisk signifikant virkning af lægemidler indeholdende modafinil ved overdreven søvnighed associeret med obstruktiv søvnforstyrrelse, søvnforstyrrelser på grund af skifteholdsarbejde og idiopatisk hypersomni er meget begrænset, og den potentielt gavnlige virkning for patienterne opvejes derfor af de identificerede risici.
English: The usual dose is 200 mg a day.
Danish: Den sædvanlige dosis er 200 mg daglig.
English: Uncommon: dyskinesia, hypertonia, hyperkinesia, amnesia, migraine, tremor, vertigo, CNS stimulation, hypoaesthesia, incoordination, movement disorder, speech disorder, taste perversion
Danish: Ikke almindelig: dyskinesi, hypertoni, hyperkinesi, amnesi, migræne, tremor, vertigo, stimulering af CNS, hypæstesi, koordinationsbesvær, bevægelsessygdomme, talebesvær, smagsforvrængning
English: Take special care with Modafinil containing medicinal products if you
Danish: Vær ekstra forsigtig med at tage modafinil-holdig medicin, hvis du
English: Serious adverse reactions affecting the nervous system have been reported spontaneously in association with modafinil, including cerebrovascular disorders, convulsions and extrapyramidal symptoms.
Danish: Der er spontane indberetninger om alvorlige bivirkninger, som berører nervesystemet, i forbindelse med modafinil, herunder cerebrovaskulære sygdomme, konvulsioner og ekstrapyramidale symptomer.
English: There is inadequate information to determine safety and efficacy of dosing in patients with renal impairment (see section 5.2).
Danish: Der er utilstrækkelig information til at bedømme sikkerhed og virkning ved nedsat nyrefunktion (se pkt.
English: • Increased cough, asthma or shortness of breath.
Danish: • Forværring af hoste eller astma, stakåndethed.
English: Anticoagulants: Due to possible suppression of CYP2C9 by modafinil the clearance of warfarin may be decreased when modafinil is administered concomitantly.
Danish: Antikoagulantia: på grund af modafinils mulige suppression af CYP2C9 nedsættes warfarinclearance ved samtidig administration af modafinil.
English: • You have sudden difficulty breathing or wheeziness or your face, mouth or throat begins to swell.
Danish: • Du pludseligt får vejrtræningsbesvær, hvæsende vejrtrækning eller hævelse af dit ansigt, mund eller hals.
English: In clinical trials, with the exception of headache, dizziness and cataplexy, all other nervous system related terms occurred almost exclusively in the modafinil treated patients.
Danish: I kliniske undersøgelser forekom alle nervesystemrelaterede reaktioner, undtagen hovedpine, svimmelhed og katapleksi, næsten udelukkende hos patienter behandlet med modafinil.
English: There is inadequate information to determine safety and efficacy of dosing in patients with renal impairment.
Danish: Der er utilstrækkelige data til at bestemme modafinils sikkerhed og virkning hos patienter med nedsat nyrefunktion.
English: • Have uncontrolled, moderate to severe high blood pressure (hypertension).
Danish: • har forhøjet blodtryk (hypertension) i moderat til alvorlig grad, og blodtrykket ikke er under kontrol.
English: • Loss of appetite, feeling sick, stomach pain, indigestion, diarrhoea or constipation
Danish: • Appetittab, kvalme, mavesmerter, fordøjelsesproblemer, diarré eller forstoppelse.
English: GENESIS PHARMA Kiffissias Avenue 274 Halandri Athens 152 32 Greece
Danish: Grækenland GENESIS PHARMA Kiffissias Avenue 274
English: Do not take Modafinil containing medicinal products if you:
Danish: Tag ikke modafinil-holdig medicin, hvis du
English: The signs may include: o mood swings or abnormal thinking, o aggression or hostility, o forgetfulness or confusion, o feeling of extreme happiness, o over-excitement or hyperactivity, o anxiety or nervousness, o depression, suicidal thoughts or behaviour, o agitation or psychosis (a loss of contact with reality which may include delusions or sensing things that are not real), feeling detached or numb, or personality disorder.
Danish: o overdreven opstemthed eller hyperaktivitet, o ængstelse eller nervøsitet, o depression, selvmordstanker eller selvmordsrelateret adfærd, o ophidselse eller psykose (realitetstab, som kan omfatte vrangforestillinger eller fornemmelse af ting, som ikke er virkelige), personlighedsforstyrrelse eller føle sig uengageret eller paralyseret.
English: If you are pregnant (or think that you may be), are planning to become pregnant, or are breast feeding, you should not take Modafinil containing medicinal products.
Danish: Du må ikke tage modafinil-holdig medicin, hvis du er gravid (eller tror du er), har planer om at blive gravid, eller hvis du ammer.
English: However, animal exposure on a mg/kg dose basis to modafinil in the general toxicology, reproductive and carcinogenicity studies was greater than the expected exposure, calculated on a similar basis, in humans.
Danish: I generelle toksikologi-, reproduktions- og karcinogenicitetstudier var modafinileksponeringen hos dyr, baseret på en mg/kg-dosis, imidlertid højere end den forventede eksponering hos mennesker, beregnet på samme måde.
English: ORCHID EUROPE LTD Building 3, Chiswick park
Danish: ORCHID EUROPE LTD
English: • Blurred vision.
Danish: • Rødmen/blussen.
English: Patients treated with modafinil should be carefully monitored for the appearance or worsening of psychotic or manic symptoms.
Danish: Patienter i modafinilbehandling skal følges tæt for forekomst eller forværring af psykotiske eller maniske symptomer.
English: The cardiovascular profile of modafinil remains the most relevant concern in the OSA population given the already elevated baseline risk.
Danish: Modafinils kardiovaskulære profil er stadig på grund af den allerede forhøjede baselinerisiko den mest relevante betænkelighed i OSA-populationen.
English: • Are allergic (hypersensitive) to modafinil, or to any of the other ingredients of these tablets (see section 6 ‘What Modafinil containing medicinal products contains').
Danish: • er overfølsom (allergisk) over for det aktive stof eller et af de øvrige indholdsstoffer (se pkt.
English: Patients treated with modafinil should be carefully monitored for the appearance or worsening of suicide-related behaviour.
Danish: Patienter i modafinilbehandling skal følges tæt under behandlingen for forekomst eller forværring af selvmordsrelateret adfærd.
English: General disorders and administration site conditions Common: asthenia, chest pain Uncommon: peripheral oedema, thirst
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig: asteni, brystsmerter Ikke almindelig: perifert ødem, tørst
English: Serious nervous system and psychiatric related events such as suicidal ideation, psychotic episodes, and depression have also been identified in association to modafinil.
Danish: Der er også identificeret alvorlige bivirkninger i nervesystemet og psykiatriske bivirkninger som selvmordstanker, psykotiske episoder og depression i forbindelse med modafinil.
English: Patients treated with modafinil should be carefully monitored for the appearance or worsening of aggressive or hostile behaviour.
Danish: Patienter i modafinilbehandling skal følges tæt for forekomst eller forværring af aggressiv eller fjendtlig adfærd.
English: The cardiovascular profile of modafinil is of particular concern in the OSA population given the already elevated baseline risk.
Danish: Modafinils kardiovaskulære profil er på grund af den allerede forhøjede baselinerisiko især bekymrende i OSA-populationen.
English: Patients should be monitored for the development of de novo or exacerbation of pre-existing psychiatric disorders (see below and Section 4.8) at every adjustment of dose and then regularly during treatment.
Danish: Patienterne skal monitoreres ved hver dosisjustering og regelmæssigt under behandlingen for udvikling af de novo eller forværring af allerede eksisterende psykiske sygdomme (se nedenfor og pkt.
English: Shift Work Sleep Disorder
Danish: Søvnforstyrrelse på grund af skifteholdsarbejde
English: Uncommon: abnormal ECG, weight increase, weight decrease
Danish: Ikke almindelig: unormalt ekg, vægtøgning, vægttab
English: Common: abdominal pain, nausea, dry mouth, diarrhoea, dyspepsia, constipation Uncommon: flatulence, reflux, vomiting, dysphagia, glossitis, mouth ulcers
Danish: Almindelig: abdominalsmerter, kvalme, mundtørhed, diarré, dyspepsi, forstoppelse Ikke almindelig: flatulens, refluks, opkastning, dysfagi, glossit, mundsår
English: Bipolar disorders
Danish: Bipolar lidelse
English: Since the effectiveness of steroidal contraceptives may be reduced when used with modafinil, alternative or concomitant methods of contraception are recommended, and for two months after discontinuation of modafinil (also see 4.5 with respect to potential interaction with steroidal contraceptives).
Danish: Effektiviteten af hormonelle svangerskabsforebyggende midler kan reduceres ved samtidig brug af modafinil, derfor anbefales en anden eller en supplerende svangerskabsforebyggende metode under behandlingen og to måneder efter seponering af modafinil (se også pkt.
English: • Hayfever symptoms including itchy/runny nose or watery eyes.
Danish: • Høfebersymptomer herunder kløende/løbende næse eller tåreflåd.
English: What Modafinil containing medicinal products contains Each tablet contains modafinil (either 100 mg or 200 mg) as the active ingredient.
Danish: • Aktivt stof: Modafinil (enten 100 mg eller 200 mg)
English: Rare cases of serious or life-threatening rash, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience.
Danish: I forbindelse med global post-marketing erfaring er der rapporteret sjældne tilfælde af alvorlige eller livstruende hududslæt herunder Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) og medicinudslæt med eosinofili og systemiske symptomer (DRESS) hos voksne og børn.
English: The onset or worsening of aggressive or hostile behaviour can be caused by treatment with modafinil.
Danish: Behandling med modafinil kan forårsage eller forværre aggressiv eller fjendtlig adfærd.
English: HOW TO TAKE MODAFINIL CONTAINING MEDICINAL PRODUCTS Always take Modafinil containing medicinal products exactly as your doctor has told you.
Danish: Tag altid modafinil-holdig medicin nøjagtigt efter lægens anvisning.
English: • Statin medicines for lowering cholesterol (e.g. atorvastatin or simvastatin).
Danish: • Statiner, som bruges til at nedsætte kolesterol i blodet (f.eks. atorvastatin eller simvastatin).
English: Route of administration
Danish: Computerweg 10
English: Very common side effects (affecting more than 1 in 10 people): • Headache
Danish: Meget almindelig bivirkninger (påvirker mere end 1 ud af 10 brugere):
English: Common: dizziness, somnolence, paraesthesia
Danish: Almindelig: svimmelhed, døsighed, paræstesi
English: Modafinil is metabolized by the liver.
Danish: Modafinil metaboliseres i leveren.
English: Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea, increased cough, asthma, epistaxis, rhinitis
Danish: Luftveje, thorax og mediastinum Ikke almindelig: dyspnø, forværring af hoste, astma, næseblod, rinit
English: Uncommon: sleep disorder, emotional lability, decreased libido, hostility, depersonalisation, personality disorder, abnormal dreams, agitation, aggression, suicidal ideation.
Danish: Almindelig: nervøsitet, søvnløshed, angst, depression, unormale tanker, konfusion Ikke almindelig: søvnproblemer, emotionel labilitet, nedsat libido, fjendtlighed, depersonalisation, personlighedsforstyrrelse, unormale drømme, agitation, aggression, selvmordstanker Sjælden: hallucinationer, mani, psykose
English: The dose of modafinil should be reduced by half in patients with severe hepatic impairment (see section 5.2).
Danish: Patienter med nedsat leverfunktion Ved svært nedsat leverfunktion skal dosis af modafinil halveres (se pkt.
English: Cephalon Pharma GmbH Fraunhoferstr.
Danish: Cephalon Pharma GmbH
English: • Omeprazole (for acid reflux, indigestion or ulcers).
Danish: • Omeprazol (til behandling af sure opstød, fordøjelsesproblemer eller mavesår).
English: • Difficulty swallowing, swollen tongue or mouth ulcers.
Danish: • Synkebesvær, hævet tunge eller mundsår.
English: If symptoms occur, discontinuation of modafinil may be required.
Danish: Det kan være nødvendigt at seponere modafinil, hvis der opstår symptomer.
English: Psychiatric disorders
Danish: Psykiske sygdomme
English: Modafinil is a wakefulness promoting agent.
Danish: Modafinil er et stof, som fremmer vågenhed.
English: Uncommon side effects (affecting fewer than 1 in 100 people):
Danish: Ikke almindelige bivirkninger (påvirker mellem 1 og 10 ud af 1.000 brugere):
English: Modafinil "Teva" 100 mg tablets
Danish: Modafinil "Teva" 100 mg tabletter
English: • Skin rash, acne or itchy skin.
Danish: • Hududslæt, akne eller hudkløe.
English: Unknown: serious skin reactions, including erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Danish: Ikke almindelig: svedtendens, udslæt, akne, pruritus Ikke kendt: alvorlige hudreaktioner inklusive erythema multiforme, Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og medicinudslæt med eosinofili og systemiske symptomer (DRESS)
English: While modafinil is not a directacting dopamine receptor agonist, in vitro and in vivo data indicate that modafinil binds to the dopamine transporter and inhibits dopamine reuptake.
Danish: In vitro og in vivo data indikerer, at modafinil binder til dopamin-transporteren og hæmmer dopamin-reuptake, selvom modafinil ikke direkte virker som en dopaminreceptoragonist.
English: Alternative or concomitant methods of contraception are recommended for patients treated with modafinil.
Danish: Det anbefales, at patienter i modafinilbehandling bruger en anden eller en supplerende svangerskabsforebyggende metode.
English: • Back pain, neck pain, muscle pain, muscle weakness, leg cramps, joint pain, twitching or tremor.
Danish: • Rygsmerter, nakkesmerter, muskelsmerter, muskelsvaghed, kramper i benene, ledsmerter samt trækninger eller rysten.
English: Narcolepsy
Danish: Narkolepsi
English: If a multi-organ hypersensitivity reaction is suspected, modafinil should be discontinued.
Danish: Modafinil skal seponeres, hvis der er mistanke om en multiorganoverfølsomhedsreaktion.
English: Uncommon: minor allergic reaction (e.g., hayfever symptoms) Unknown: Angioedema, urticaria (hives).Hypersensitivity reactions (characterised by features such as fever, rash, lymphadenopathy and evidence of other concurrent organ involvement)
Danish: Ikke almindelig: lette allergiske reaktioner (f.eks. høfeberlignende symptomer) Ikke kendt: angioødem, urticaria.
English: 200mg tablets
Danish: 200mg tabletter
English: Modafinil Generis 100 mg tablets
Danish: Modafinil Generis 100 mg tabletter
English: Insomnia Because modafinil promotes wakefulness, caution should be paid to signs of insomnia.
Danish: Der skal udvises forsigtighed ved tegn på insomni, da modafinil fremmer vågen tilstand.
English: • Loss of sex drive.
Danish: • Nedsat sexlyst
English: Positive de-challenge and/or re-challenge was reported in some cases.
Danish: Der er i nogle tilfælde rapporteret om positivt ophør med eksponering og/eller geneksponering.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Modafinil containing medicinal products 100 mg Tablets Modafinil containing medicinal products 200 mg Tablets Modafinil
Danish: Modafinilholdig medicin tabletter 100 mg Modafinil-holdig medicin tabletter 200 mg Modafinil
English: The excretion of modafinil and its metabolites is chiefly renal, with a small proportion being eliminated unchanged (< 10% of the dose).
Danish: En lille del (<10% af dosis) udskilles uændret.
English: MODAFINIL 200 mg tablets
Danish: MODAFINIL 200 mg tabletter
English: If you are affected or you find that while using this medication you still feel very sleepy, do not attempt to drive or operate machinery.
Danish: Forsøg ikke at køre bil eller eller motorcykel eller arbejde med værktøj eller maskiner, hvis du føler dig påvirket af medicinen eller stadig føler dig meget træt.
English: What Modafinil containing medicinal products is and what it is used for Before you take Modafinil containing medicinal products How to take Modafinil containing medicinal products Possible side effects
Danish: Det skal du vide, før du begynder at tage modafinilholdig medicin Sådan skal du tage modafinil-holdig medicin Bivirkninger
English: 200 MG tablets
Danish: 200 MG tabletter
English: Serious rash, including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Drug Rash with Eosinophilia and Systemic Symptoms
Danish: Alvorlige tilfælde af hududslæt herunder Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og medicinudslæt med eosinofili og systemiske symptomer Der er set alvorlige tilfælde af hududslæt, som nødvendiggjorde hospitalsindlæggelse og seponering af modafinil.
English: Serious rash requiring hospitalisation and discontinuation of treatment has been reported with the use of modafinil occurring within 1 to 5 weeks after treatment initiation.
Danish: Udslættene opstod 1-5 uger efter behandlingens start.
English: Infections and infestations Uncommon: pharyngitis, sinusitis
Danish: Infektioner og parasitære sygdomme Ikke almindelig: faryngit, sinuit
English: BEFORE YOU TAKE MODAFINIL CONTAINING MEDICINAL PRODUCTS
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE MODAFINIL-HOLDIG MEDICIN
English: Musculoskeletal and connective tissue disorders Uncommon: back pain, neck pain, myalgia, myasthenia, leg cramps, arthralgia, twitch
Danish: Knogler, led, muskler og bindevæv Ikke almindelig; rygsmerter, nakkesmerter, myalgi, myasteni, kramper i benene, artralgi, trækninger
English: Anděl City
Danish: East Sussex
English: tablets
Danish: INDLÆGSSEDDEL
English: CEPHALON France 20, rue Charles Martigny 94701 Maisons-Alfort Cedex
Danish: 94701 Maisons-Alfort Cedex
English: Obstructive Sleep Apnoea
Danish: Obstruktiv søvnapnø
English: • Sweating.
Danish: • Svedtendens.
English: Contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.
Danish: Kontakt straks skadestue eller læge, hvis du har taget for meget modafinil-holdig medicin.
English: 100. mg tablets
Danish: 100. mg tabletter
English: Radlická 1c
Danish: Anděl City Radlická 1c 150 00 Praha 5
English: Modiodal® 100 mg tablets
Danish: Modiodal® 100 mg tabletter
English: MODIODAL 100MG tablets
Danish: MODIODAL 100MG tabletter
English: MODAFINIL 100 mg tablets
Danish: MODAFINIL 100 mg tabletter
English: Modafinil should be discontinued in patients who develop arrhythmia or moderate to severe hypertension and not restarted until the condition has been adequately evaluated and treated.
Danish: Modafinil skal seponeres, hvis patienterne får arytmi eller moderat til svær hypertension.
English: Product name Strength Pharmaceutical form
Danish: Lægemiddelform Indgivelsesvej
English: What Modafinil containing medicinal products looks like and the contents of the pack [To be completed nationally]
Danish: • Øvrige indholdsstoffer: [Udfyldes nationalt] Udseende og pakningsstørrelser [Udfyldes nationalt]
English: MODIODAL 100 mg tablets
Danish: MODIODAL 100 mg tabletter
English: • Flushing.
Danish: • Migræne.
English: Modafinil Teva 100 mg tablets
Danish: MODAFINIL TEVA 100 mg tabletter
English: 100mg tablets
Danish: 100mg tabletter
English: 100 mg tablets
Danish: 100 mg tabletter
English: If psychotic or manic symptoms occur, discontinuation of modafinil may be required.
Danish: Modafinil skal seponeres, hvis der opstår psykotiske eller maniske symptomer.
English: WHAT MODAFINIL CONTAINING MEDICINAL PRODUCTS IS AND WHAT IT IS USED FOR
Danish: Modafinil-holdig medicin indeholder indeholder:
English: Data will be presented in future modafinil PSURs.
Danish: Dataene fremlægges i fremtidige procedurer for fremsendelse af periodiske sikkerhedsopdateringer (PSUR'er).
English: Numbness or tingling of the hands or feet (‘pins and needles').
Danish: • Følelsesløshed eller prikkende fornemmelse i hænder og fødder.
English: If any of these side effects become troublesome or you experience any side effects not listed, please tell your doctor pharmacist or nurse.
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: • Chest pain
Danish: • Hovedpine
English: 1 CCID50: Cell Culture Infective Dose 50 %
Danish: CCID50: Cell Culture Infective Dosis 50 %
English: Pharmaceutical Form
Danish: Lægemiddelform Dyrearter
English: EU Number
Danish: EU Nummer Originalt navn
English: Content Package size Withdrawal period
Danish: Indhold Pakningsstør relse
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU) nummer (Særnavn) Navn
English: EMA/CHMP/816057/2012
Danish: EMA/CVMP/816057/2012
English: The company that applied for authorisation is Merz Pharmaceuticals GmbH, Germany.
Danish: Virksomheden, der har indgivet ansøgningen, er Merz Pharmaceuticals GmbH, Tyskland.
English: What is Balaxur?
Danish: Hvad er Balaxur?
English: The effects of Balaxur were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Balaxur blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Therefore, the CHMP was of the opinion that the benefits of Balaxur did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CHMP var derfor af den opfattelse, at fordelene ved Balaxur ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: The company informed the CHMP that there are no patients currently included in clinical trials with Balaxur in the European Union.
Danish: Virksomheden har til CHMP oplyst, at der på nuværende tidspunkt ikke deltager nogen patienter i kliniske undersøgelser med Balaxur i EU.
English: What was Balaxur expected to be used for?
Danish: Hvad forventedes Balaxur anvendt til?
English: How is Balaxur expected to work?
Danish: Hvordan forventes Balaxur at virke?
English: Balaxur is a combination treatment containing two active substances which are already authorised in the EU to treat the symptoms of Alzheimer's disease.
Danish: Balaxur er et lægemiddel, der består af en kombination af to aktive stoffer, som allerede er godkendt i EU til behandling af symptomerne på Alzheimers sygdom.
English: Balaxur is a medicine that contains two active substances, memantine hydrochloride and donepezil hydrochloride.
Danish: Balaxur er et lægemiddel, der indeholder de to aktive stoffer memantinhydrochlorid og donepezilhydrochlorid.