FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take the Entacapone Orion tablet with your levodopa dose, you should continue the treatment by taking the next Entacapone Orion tablet with your next levodopa dose.
Danish: Hvis du har glemt at tage din Entacapone Orion-tablet sammen med din levodopadosis, genoptager du behandlingen ved at tage den næste Entacapone Orion-tablet sammen med den næste levodopadosis.
English: Microcrystalline cellulose Croscarmellose sodium Povidone
Danish: Cellulose, mikrokrystallinsk Croscarmellosenatrium Povidon
English: Do not use Entacapone Orion during pregnancy or if you are breast-feeding.
Danish: Du må ikke tage Entacapone Orion under graviditet, eller hvis du ammer.
English: • rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa,
Danish: • rimiterol, isoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, metyldopa, apomorphin
English: • Neuroleptic Malignant Syndrome (NMS) is a rare severe reaction to medicines used to treat disorders of the nervous system.
Danish: • malignt neuroleptikasyndrom (MNS) er en sjælden, men alvorlig bivirkning til medicin, der anvendes til behandling af forstyrrelser i nervesystemet.
English: Study I: Daily On time (h) Entacapone (n=85) Placebo (n=86)
Danish: Undersøgelse I: Daglig ON tid (timer) Entacapon (n=85)
English: • a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems.
Danish: • en sjælden, men alvorlig muskelsygdom (rabdomyolyse), som medfører muskelsmerter, -ømhed og -svaghed, og som kan give nyreproblemer.
English: prolonged muscle cramps (dystonia);
Danish: langvarige muskelkramper (dystoni)
English: • harmless reddish-brown discolouration of urine.
Danish: • kvalme • harmløs farveændring af urinen.
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Entacapone Orion.
Danish: Den højeste anbefalede dosis er 10 tabletter pr. dag, dvs. 2.000 mg Entacapone Orion.
English: The recommended dose of Entacapone Orion is one 200 mg tablet with each levodopa dose.
Danish: Den anbefalede dosis af Entacapone Orion er en 200 mg tablet sammen med hver levodopadosis.
English: If you stop taking Entacapone Orion Do not stop taking Entacapone Orion unless your doctor tells you to.
Danish: Hvis du holder op med at tage Entacapone Orion Du må kun ophøre med at tage Entacapone Orion, hvis din læge har sagt det.
English: No overt teratogenic or primary foetotoxic effects were observed in animal studies in which the exposure levels of entacapone were markedly higher than the therapeutic exposure levels.
Danish: Der er ikke observeret nogen teratogen eller primær føtotoksisk virkning i dyrestudier, hvor entacapon blev administreret i betydeligt højere doser end de terapeutisk anbefalede doser.
English: Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
Danish: Hverken MNS eller rabdomyolyse er blevet rapporteret i forbindelse med entacaponbehandling i kontrollerede studier, hvor entacaponbehandling blev brat afsluttet.
English: Entacapone Orion taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Danish: Entacapone Orion taget sammen med levodopa kan nedsætte dit blodtryk, hvilket kan få dig til at føle dig ør i hovedet eller svimmel.
English: Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease.
Danish: Rabdomyolyse sekundært til svære dykinesier eller malignt neuroleptikasyndrom (MNS) er i sjældne tilfælde set hos patienter med Parkinsons sygdom.
English: The safety and efficacy of Entacapone Orion in children below age 18 have not been established.
Danish: Entacapone Orions sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Therefore, the use of Entacapone Orion in children or adolescents cannot be recommended.
Danish: Brug af Entacapone Orion frarådes derfor til børn eller unge.
English: Entacapone Orion in association with levodopa may have a major influence on the ability to drive and use machines.
Danish: Entacapone Orion sammen med levodopa kan i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Experience with Entacapone Orion in patients under 18 years is limited.
Danish: Der er begrænset erfaring med brug af Entacapone Orion til patienter under 18 år.
English: • antidepressants including desipramine, maprotiline, venlafaxine, paroxetine;
Danish: • lægemidler mod depression, herunder desipramin, maprotilin, venlafaxin, paroxetin
English: Women should not breast-feed during treatment with entacapone.
Danish: Kvinder bør derfor ikke amme under behandling med entacapon.
English: Entacapone Orion tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Danish: Entacapone Orion-tabletter indeholder entacapon og bruges sammen med levodopa til behandling af Parkinsons sygdom.
English: CARTON AND BOTTLE LABEL
Danish: ÆSKE OG ETIKET
English: NMS, including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (e.g. agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase.
Danish: MNS, inklusive rabdomyolyse og hypertermi, er karakteriseret ved muskelsymptomer (stivhed, myokloni, rysten), ændring af mental status (f.eks. agitation, konfusion, koma), hypertermi, autonomisk dysfunktion (takykardi, labilt blodtryk) og forhøjet serumkreatinfosfokinase.
English: • warfarin used to thin the blood;
Danish: • warfarin (blodfortyndende medicin)
English: Macrogol
Danish: Macrogoler
English: Yellow iron oxide (E 172) Red iron oxide (E 172) Titanium dioxide (E 171)
Danish: Gul jernoxid (E172) Rød jernoxid (E172) Titandioxid (E171).
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11-26%].
Danish: 5.2), kan entacapon potentielt interferere med lægemidler med metabolisme, der er afhængig af dette isoenzym, såsom S-warfarin.I et interaktionsstudie med raske forsøgspersoner sås ingen ændringer af S-warfarin på plasmaniveau, mens AUC for R-warfarin i gennemsnit øgedes med 18% [CI90 11-26%].
English: Entacapone Orion is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Danish: Entacapone Orion tages sammen med medicin, der indeholder levodopa (enten levodopa/carbidopapræparater eller levodopa/benserazid-præparater).
English: Renal insufficiency does not affect the pharmacokinetics of entacapone and there is no need for dose adjustment.
Danish: Nyreinsufficiens påvirker ikke entacapons farmakokinetik, og det er ikke nødvendigt at justere doseringen ved nyreinsufficiens.
English: What Entacapone Orion contains - The active substance is entacapone.
Danish: Entacapone Orion indeholder: - Aktivt stof: Entacapon.
English: Usually side effects caused by Entacapone Orion are mild to moderate.
Danish: De hyppigste bivirkninger, der skyldes brug af Entacapone Orion, er milde til moderate.
English: If you take more Entacapone Orion than you should In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.
Danish: Hvis du har taget for mange Entacapone Orion Hvis du har taget en overdosis af Entacapone Orion, skal du straks henvende dig til din læge, på apoteket eller nærmeste hospital.
English: - The other ingredients in the tablet core are microcrystalline cellulose, croscarmellose sodium,
Danish: - Øvrige indholdsstoffer i tabletkernen: cellulose, mikrokrystallinsk; croscarmellosenatrium;
English: Excipient with known effect Each film-coated tablet contains 0.53 mg soya lecithin.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 0,53 mg sojalecithin.
English: • dizziness, tiredness, increased sweating, fall;
Danish: • svimmelhed, træthed, øget svedtendens, fald
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Entacapone Orion in association with levodopa.
Danish: Patienter og omsorgspersoner skal gøres opmærksomme på, at symptomer på patologiske vane- og impulshandlinger inklusive patologisk spillelyst, forøget libido og hyperseksualitet, kompulsiv brug af penge og indkøb, spiseorgie og tvangsspisning kan opstå hos patienter, som får dopaminagonister og/eller anden dopaminerg terapi, såsom Entacapone Orion i kombination med levodopa.
English: In clinical studies, undesirable dopaminergic effects, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
Danish: I kliniske studier var dopaminerge bivirkninger f.eks. dyskinesier hyppigere hos de patienter, der behandledes med entacapon og dopaminerge agonister (som f.eks. bromocriptin), selegilin eller amantadin sammenlignet med de patienter, der fik placebo sammen med agonisterne.
English: It is characterised by stiffness, muscle twitching, shaking, agitation and confusion, coma, high body temperature, increased heart rate, and unstable blood pressure;
Danish: Det er karakteriseret ved stivhed, muskeltrækninger, rysten, uro og forvirring, bevidstløshed, høj feber, hurtig hjerterytme og ustabilt blodtryk.
English: Thus, entacapone should be administered cautiously to patients being treated with medicinal products metabolised by catechol-Omethyl transferase (COMT), e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
Danish: Entacapon bør derfor administreres med forsigtighed til patienter, der behandles med lægemidler, der metaboliseres af catechol-O-metyl transferase (COMT), f.eks. rimiterol, isoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfamethyldopa og apomorphin (se pkt.
English: - A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Danish: - Malignt neuroleptikasyndrom (MNS) og/eller ikke-traumatisk rabdomyolyse i anamnesen.
English: - Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof eller over for jordnødder eller soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E 171).
Danish: macrogol; sojalecithin; gul jernoxid (E172); rød jernoxid (E172) og titandioxid (E171).
English: Do not take Entacapone Orion
Danish: Tag ikke Entacapone Orion
English: However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catechol structured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine,alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Danish: Der er stadig begrænset erfaring med samtidig administration af entacapon og en række lægemidler som MAO-A-hæmmere, tricykliske antidepressiva, noradrenalin re-uptake-hæmmere (desipramin, maprotilin og venlafaxin) samt lægemidler, som metaboliseres af COMT (f.eks. katechol-strukturforbindelser: rimiterol, isoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metyldopa, apomorphin og paroxetin).
English: Adverse drug reactions*
Danish: Bivirkninger*
English: See section 4 Possible side effects for the characteristics of NMS;
Danish: Se symptomer på MNS i punkt 4 Bivirkninger;
English: The other major class of adverse reactions are gastrointestinal symptoms, including nausea, vomiting, abdominal pain, constipation and diarrhoea.
Danish: Den anden hyppige gruppe af bivirkninger er relateret til mave-tarmkanalen og inkluderer kvalme, opkastning, abdominalsmerter, forstoppelse og diarré.
English: Skin, hair, beard and nail discolourations
Danish: Misfarvning af hud, hår, skæg og negle
English: Entacapone Orion has no effect on relieving the symptoms of Parkinson's disease unless taken with levodopa.
Danish: Entacapone Orion har kun lindrende virkning på symptomerne fra Parkinsons sygdom, hvis det tages sammen med levodopa.
English: For the characteristics of NMS see Section 4 Possible side effects.
Danish: Se symptomer på MNS i punkt 4 Bivirkninger.
English: Entacapone thus prolongs the clinical response to levodopa.
Danish: Dermed forlænger entacapon den kliniske virkning af levodopa.
English: If you forget to take Entacapone Orion
Danish: Hvis du har glemt at tage Entacapone Orion
English: • if you experience diarrhoea, monitoring of your weight is recommended in order to avoid potentially excessive weight loss;
Danish: Regelmæssig kontrol af din vægt anbefales for at undgå et eventuelt meget stort vægttab;
English: Bottle label
Danish: Flaskeetiket
English: Entacapone Orion contains soya lecithin.
Danish: Entacapone Orion indeholder sojalecithin.
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Entacapone Orion in association with levodopa (see section 4.4).
Danish: Patologisk spillelyst, forøget libido, hyperseksualitet, kompulsiv brug af penge og indkøb, spiseorgie og tvangsspisning kan opstå hos patienter, som får dopaminagonister og/eller anden dopaminerg terapi, såsom Entacapone Orion i kombination med levodopa (se pkt.
English: • heart or artery disease events (e.g. chest pain).
Danish: • symptomer på hjerte- eller karsygdom (f.eks. brystsmerter).
English: Entacapone is administered orally and simultaneously with each levodopa/carbidopa or levodopa/benserazide dose.
Danish: Entacapon administreres oralt samtidig med hver dosering af levodopa/benserazid eller levodopa/carbidopa.
English: • decreased appetite, weight loss;
Danish: • nedsat appetit, vægttab
English: Entacapone Orion aids levodopa in relieving the symptoms of Parkinson's disease.
Danish: Entacapone Orion understøtter levodopa og lindrer derved symptomerne på Parkinsons sygdom.
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjælden (kan påvirke op til 1 ud af 10.000 personer)
English: What Entacapone Orion looks like and contents of the pack Entacapone Orion 200 mg film-coated tablets are brownish-orange, oval tablets with "COMT" engraved on one side.
Danish: Entacapone Orion 200 mg filmovertrukne tabletter er brun-orange, ovale tabletter mærket med ”COMT” på den ene side.
English: CI95% 45 min, 1 h 56 min Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Danish: Undersøgelse II: Daglig ON tid (%) Entacapon (n=103)
English: Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Danish: Lægen vil tale med dig om, hvordan du kan reducere og kontrollere disse symptomer.
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjælden (kan påvirke op til 1 ud af 1.000 personer)
English: Entacapone Orion contains soya lecithin
Danish: Entacapone Orion indeholder sojalecithin
English: What you need to know before you take Entacapone Orion
Danish: Det skal du vide, før du begynder at tage Entacapone Orion
English: Urine discoloration General disorders and administration site conditions Common:
Danish: Nyrer og urinveje Meget almindelig: Farveændring af urin Almene symptomer og reaktioner på administrationsstedet Almindelig:
English: Each tablet contains 200 mg of entacapone,
Danish: Hver tablet indeholder 200 mg entacapon,
English: In addition, Entacapone Orion taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Danish: Entacapone Orion taget sammen med levodopa kan endvidere gøre dig meget søvnig eller af og til få dig til pludseligt at falde i søvn.
English: • if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Entacapone Orion);
Danish: Kontakt din læge eller apotekspersonalet, som kan undersøge, om din medicin kan tages sammen med Entacapone Orion;
English: They are packed in bottles.
Danish: Tabletterne er pakket i en tabletbeholder.
English: entacapone orion 200 mg [carton only]
Danish: entacapone orion 200 mg [på æsken]
English: Each tablet contains 200 mg of entacapone.
Danish: Hver tablet indeholder 200 mg entacapon.
English: • if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time, a general medical evaluation including liver function should be considered.
Danish: • hvis du inden for relativt kort tid får tiltagende appetitløshed, føler dig svækket, udmattet og taber i vægt.
English: Soya lecithin
Danish: Sojalecithin
English: - The film-coating contains partly hydrolysed polyvinyl alcohol, talc, macrogol, soya lecithin,
Danish: - Øvrige indholdsstoffer i filmovertrækket: polyvinylalkohol, delvist hydrolyseret; talcum;
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan påvirke op til 1 ud af 10 personer)
English: If you are allergic to peanut or soya, do not use this medicine.
Danish: Du må ikke tage denne medicin, hvis du er allergisk over for jordnødder eller soja.
English: soya lecithin.
Danish: sojalecithin.
English: • abdominal pain.
Danish: • mavesmerter.
English: • abnormal results in liver function test.
Danish: • unormale leverfunktionsprøver.
English: • Entacapone Orion taken with levodopa may rarely make you feel very drowsy during the day,
Danish: • Entacapone Orion taget sammen med levodopa kan i sjældne tilfælde få dig til at føle dig meget døsig om dagen og medføre, at du pludseligt falder i søvn.
English: What Entacapone Orion is and what it is used for What you need to know before you take Entacapone Orion How to take Entacapone Orion Possible side effects
Danish: Det skal du vide, før du begynder at tage Entacapone Orion Sådan skal du tage Entacapone Orion Bivirkninger
English: Entacapone Orion taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Danish: Samtidig brug af Entacapone Orion og levodopa kan gøre dig mere sløv, og nogen gange kan du pludseligt falde i søvn.
English: Entacapone Orion 200 mg film-coated tablets entacapone
Danish: Entacapone Orion 200 mg filmovertrukne tabletter entacapon
English: • if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon;
Danish: Kontakt lægen, da det kan være tegn på betændelse i tyktarmen;
English: Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
Danish: På grund af affinitet til cytokrom P450 2C9 in vitro (se pkt.
English: • being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth;
Danish: • opkastning, diarré, mavesmerter, forstoppelse, mundtørhed
English: • Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias);
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 personer) • ukontrollerbare bevægelser med besvær med at udføre ønskede bevægelser (dyskinesier)
English: apomorphine;
Danish: • nældefeber.
English: Similarly, no interactions between entacapone and selegiline were observed in repeated-dose studies in parkinsonian patients.
Danish: I kliniske studier med gentagne doser hos Parkinsonpatienter fandtes ikke interaktion med selegilin.
English: Gastrointestinal disorders Very common:
Danish: Mave-tarm-kanalen Meget almindelig: Kvalme Almindelig:
English: How to take Entacapone Orion
Danish: Sådan skal du tage Entacapone Orion
English: Entacapone Orion 200 mg film-coated tablets
Danish: Entacapone Orion 200 mg filmovertrukne tabletter.
English: White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP)
Danish: Hvid high-density polyethylen (HDPE) beholder med hvidt forseglet polypropylen (PP) låg indeholdende 30, 60, 100 eller 175 tabletter.
English: Nervous system disorders Very common:
Danish: Meget almindelig: Dyskinesi Almindelig:
English: It is available as tablets (5 mg).
Danish: Det fås som tabletter (5 mg).
English: The full EPAR for Desloratadine Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Desloratadine Actavis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine Actavis on 13 January 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Desloratadine Actavis den 13. januar 2012.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Desloratadine Actavis.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Desloratadin Actavis.
English: This is a summary of the European public assessment report (EPAR) for Desloratadine Actavis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Desloratadine Actavis.
English: For more information about treatment with Desloratadine Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Desloratadine Actavis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Desloratadine Actavis is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Danish: Desloratadine Actavis anvendes til lindring af symptomer på allergisk rhinitis (betændelse i næsepassagerne, som forårsages af allergi, f.eks. høfeber eller allergi over for støvmider) eller urticaria (en hudlidelse forårsaget af allergi med symptomer, der omfatter kløe og nældefeber).
English: The CHMP concluded that, in accordance with EU requirements, Desloratadine Actavis has been shown to have comparable quality and to be bioequivalent to Aerius.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Desloratadine Actavis er af sammenlignelig kvalitet og er bioækvivalent med Aerius.
English: The Committee recommended that Desloratadine Actavis be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Desloratadine Actavis.
English: This means that Desloratadine Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
Danish: Det betyder, at Desloratadine Actavis er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, nemlig Aerius.
English: The active substance in Desloratadine Actavis, desloratadine, is an antihistamine.
Danish: Det aktive stof i Desloratadine Actavis, desloratadin, er et antihistamin.