FrancophonIA/ELRC3.0 huggingface dataset:
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtess.
Danish: Den højeste anbefalede dosis er 10 tabletter pr. dag, dvs. 2.000 mg Comtess.
English: If you forget to take the Comtess tablet with your levodopa dose, you should continue the treatment by taking the next Comtess tablet with your next levodopa dose.
Danish: Hvis du har glemt at tage din Comtess-tablet sammen med din levodopadosis, genoptager du behandlingen ved at tage den næste Comtess-tablet sammen med den næste levodopadosis.
English: Therefore, the use of Comtess in children or adolescents cannot be recommended.
Danish: Brug af Comtess frarådes derfor til børn eller unge.
English: After taking one of them, wait at least 2 to 3
Danish: Vent mindst 2 til 3 timer efter, at du har taget det ene af dem, til du tager det andet.
English: Your doctor may advise you to slowly discontinue the treatment with Comtess and other medicines to treat Parkinson's disease.
Danish: Din læge kan råde dig til langsomt at stoppe behandlingen med Comtess og andre lægemidler til behandling af Parkinsons sygdom.
English: Entacapone decreases the metabolic loss of levodopa to 3-O-methyldopa (3-OMD) by inhibiting the COMT enzyme.
Danish: Entacapon nedsætter det metaboliske tab af levodopa til 3-O-metyldopa (3OMD) via en inhibering af COMT- enzymet.
English: Comtess taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Danish: Comtess taget sammen med levodopa kan nedsætte dit blodtryk, hvilket kan få dig til at føle dig ør i hovedet eller svimmel.
English: The recommended dose of Comtess is one 200 mg tablet with each levodopa dose.
Danish: Den anbefalede dosis af Comtess er en 200 mg tablet sammen med hver levodopadosis.
English: What Comtess contains - The active substance is entacapone.
Danish: Comtess indeholder: - Aktivt stof: Entacapon.
English: Comtess in association with levodopa may have a major influence on the ability to drive and use machines.
Danish: Comtess sammen med levodopa kan i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease.
Danish: Rhabdomyolyse sekundært til svære dykinesier eller malignt neuroleptikasyndrom (MNS) er i sjældne tilfælde set hos patienter med Parkinsons sygdom.
English: Comtess tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Danish: Comtess-tabletter indeholder entacapon og bruges sammen med levodopa til behandling af Parkinsons sygdom.
English: What you need to know before you take Comtess
Danish: Det skal du vide, før du begynder at tage Comtess
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 (rhabdomyolyse), som medfører muskelsmerter, -ømhed og -svaghed, og som kan give nyreproblemer.
English: The safety and efficacy of Comtess in children below age 18 have not been established.
Danish: Pædiatrisk population Comtess' sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
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 dyreforsøg, hvor entacapon blev administreret i betydeligt højere doser end de terapeutisk anbefalede doser.
English: Usually side effects caused by Comtess are mild to moderate.
Danish: De hyppigste bivirkninger, der skyldes brug af Comtess, er milde til moderate.
English: If you take more Comtess than you should In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.
Danish: Hvis du har taget en overdosis af Comtess, skal du straks henvende dig til din læge, på apoteket eller nærmeste hospital.
English: Comtess is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Danish: Comtess tages sammen med medicin, der indeholder levodopa (enten levodopa/carbidopa-præparater eller levodopa/benserazid-præparater).
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 rhabdomyolyse og hypertermi er karakteriseret ved muskelsymptomer (stivhed, myocloni, rysten), ændring af mental status (f.eks. agitation, konfusion, koma), hypertermi, autonomisk dysfunktion (tachycardi, labilt blodtryk) og forhøjet serumkreatinphosphokinase.
English: • Excessive movements (hyperkinesias), worsening of symptoms of Parkinson´s disease,
Danish: • overdrevne bevægelser (hyperkinesier), forværring af symptomer på Parkinsons sygdom, langvarige muskelkramper (dystoni)
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: 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 Comtess in association with levodopa.
Danish: Patienter og behandlere skal gøres opmærksomme på, at adfærdssymptomer på patologisk vane- og impulskontrol inklusiv patologisk spillelyst, forøget libido, hyperseksualitet, kompulsiv brug af penge og indkøb, spiseorgie og tvangsspisning kan opstå hos patienter, som bliver behandlede med dopaminagonister og/eller andre dopaminerge behandlinger, såsom Comtess i kombination med levodopa.
English: In clinical studies the most common adverse reactions leading to discontinuation of entacapone treatment have been gastrointestinal symptoms (e.g. diarrhoea, 2.5%) and increased dopaminergic adverse reactions of levodopa (e.g. dyskinesias, 1.7%).
Danish: I kliniske studier har den mest almindelige bivirkning, der har ført til afbrydning af behandlingen med entacapon, været symptomer fra mave-tarmkanalen (f.eks. diarré 2,5%) og øget dopaminerg bivirkning af levodopa (f.eks. dyskinesi
English: Comtess contains soya lecithin.
Danish: Comtess indeholder sojalecithin.
English: Comtess has no effect on relieving the symptoms of Parkinson's disease unless taken with levodopa.
Danish: Comtess har kun lindrende virkning på symptomerne fra Parkinsons sygdom, hvis det tages sammen med levodopa.
English: Talk to your doctor or pharmacist before taking Comtess:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet før du tager Comtess:
English: yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E 171).
Danish: sojalecithin; gul jernoxid (E172); rød jernoxid (E172) og titandioxid (E171).
English: - Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and entacapone (see section 4.5).
Danish: - Samtidig brug af en selektiv MAO-A-hæmmer plus en selektiv MAO-B-hæmmer og entacapon (se pkt.
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, alfa-metyl-dopa og apomorphin(se pkt.
English: • dizziness, tiredness, increased sweating, fall ;
Danish: • svimmelhed, træthed, øget svedtendens, fald
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 overfor jordnødder eller soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: Comtess aids levodopa in relieving the symptoms of Parkinson's disease.
Danish: Comtess understøtter levodopa og lindrer derved symptomerne på Parkinsons sygdom.
English: - The film-coating contains partly hydrolysed polyvinyl alcohol, talc, macrogol, soya lecithin,
Danish: - Øvrige indholdsstoffer i filmovertrækket: polyvinylalkohol, delvist hydrolyseret; talcum; macrogol;
English: What Comtess looks like and contents of the pack Comtess 200 mg film-coated tablets are brownish-orange, oval tablets with "COMT" engraved on one side.
Danish: Comtess 200 mg filmovertrukne tabletter er brun-orange, ovale tabletter mærket med ”COMT” på den ene side.
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 mavetarmkanalen og inkluderer kvalme, opkastning, abdominale smerter, forstoppelse og diarré.
English: • Comtess taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
Danish: • Comtess 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: 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. catecholstructured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine,
Danish: Der er stadig begrænset erfaring med samtidig administration af entacapon og en række lægemidler som MAO-A-hæmmere, tricykliske antidepressiva, noradrenalin reuptake-hæmmere (desipramin, maprotilin og venlafaxin) samt lægemidler, som metaboliseres af COMT (f.eks. katechol-strukturforbindelser: rimiterol, isoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-methyldopa, apomorphin og paroxetin).
English: Diarrhoea, abdominal pain, dry mouth, constipation, vomiting
Danish: Diarré, abdominale smerter, mundtørhed, forstoppelse, opkastning
English: 2D barcode carrying the unique identifier included [carton only]
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
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 Comtess 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 bliver behandlede med dopaminagonister og/eller andre dopaminerge behandlinger, såsom Comtess i kombination med levodopa (se pkt.
English: comtess 200 mg [carton only]
Danish: comtess 200 mg [på æsken]
English: Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Danish: Lægen vil diskutere måder at reducere og kontrollere disse symptomer.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 personer)
English: In addition, Comtess taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Danish: Comtess 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 Comtess);
Danish: Kontakt din læge eller apotekspersonalet, som kan undersøge, om din medicin kan tages sammen med Comtess;
English: - The other ingredients in the tablet core are microcrystalline cellulose, croscarmellose sodium,
Danish: - Øvrige indholdsstoffer i tabletkernen: cellulose, mikrokrystallinsk; croscarmellosenatrium; povidon og magnesiumstearat.
English: Comtess 200 mg film-coated tablets Entacapone
Danish: Comtess 200 mg filmovertrukne tabletter entacapon
English: Comtess 200 mg film-coated tablets entacapone
Danish: Comtess 200 mg filmovertrukne tabletter Entacapon
English: How to take Comtess
Danish: Sådan skal du tage Comtess
English: Comtess 200 mg film-coated tablets
Danish: Comtess 200 mg filmovertrukne tabletter.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Comtess Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Comtess taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Danish: Samtidig brug af Comtess og levodopa kan gøre dig mere sløv, og nogen gange kan du pludseligt falde i søvn.
English: What Comtess is and what it is used for What you need to know before you take Comtess How to take Comtess
Danish: Det skal du vide, før du begynder at tage Comtess Sådan skal du tage Comtess Bivirkninger
English: No special treatment is required.
Danish: Der kræves ingen speciel behandling.
English: Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Danish: Andre farmaceutiske former/styrker kan være mere passende til administration hos denne population.
English: Patients were re-randomised at 3 weeks.
Danish: Patienter blev randomiseret igen efter 3 uger.
English: Terminal half life (t½) is 3.5-4 hours.
Danish: Terminal halveringstid (t½) er 3,5-4 timer.
English: This dosage may be continued for up to thirteen weeks.
Danish: Denne dosis kan fortsættes i op til tretten uger.
English: - If you have been told you suffer from an autoimmune disease (where the body is ‘attacked' by its own immune system).
Danish: - Hvis du har fået at vide, at du lider af en autoimmun sygdom (hvor kroppen 'angribes' af sit eget immunsystem).
English: Most were mild to moderate in severity.
Danish: De fleste var milde til moderate i sværhedsgrad.
English: There are no known harmful effects if treatment is interrupted or ended early.
Danish: Der er ingen kendte skadelige virkninger, hvis behandlingen afbrydes eller afsluttes før tiden.
English: Taking more than the recommended daily dose may make you feel drowsy.
Danish: Hvis du tager mere end den anbefalede daglige dosis, kan du føle dig døsig.
English: System Organ Class
Danish: Systemorgan klasser
English: • Presence of red blood cells in the urine
Danish: • Tilstedeværelse af røde blodceller i urinen
English: The study showed that the benefit observed after 3 weeks is maintained for up to 3 months but failed the primary analysis set at 6 months.
Danish: Forsøget viste, at den fordel, der blev observeret efter 3 uger, blev bevaret i op til 3 måneder, men ikke ved den primære analyse efter de fastlagte 6 måneder.
English: Several cases of overdose have been reported post-marketing.
Danish: Adskillige tilfælde af overdosering er blevet rapporteret efter markedsføring.
English: There is a significant first pass effect with an estimated first pass metabolism of 85%.
Danish: Der er en signifikant førstepassage (first pass)effekt med en skønnet first pass-metabolisme på 85 %.
English: - If you suffer from liver or kidney problems.
Danish: - Hvis du lider af lever- eller nyreproblemer.
English: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be established from the available data).
Danish: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not give this medicine to children between the ages of 0 to 18 years as it has not been tested and its effects are unknown.
Danish: Denne medicin må ikke gives til børn og teenagere mellem 0 og 18 år, da det ikke er testet på dem, og dets virkninger på dem ikke er kendt.
English: • Loss of consciousness or fainting
Danish: • Tab af bevidsthed eller besvimelse
English: Older People
Danish: Ældre mennesker
English: Another medicine containing melatonin may be more appropriate for administration to children between the ages of 2 to 18 - please ask your doctor or pharmacist for advice.
Danish: E andet lægemiddel indeholdende melatonin kan være mere passende til indgift hos børn i alderen 2 til 18 år - søg rådgivning hos din læge eller apotekespersonalet.
English: ‘Primary' means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.
Danish: ”Primær” vil sige, at søvnløsheden ikke har nogen identificeret årsag, hverken medicinsk, psykisk eller miljømæssig årsag.
English: If you are affected, you should not drive or operate machinery.
Danish: Hvis du er døsig, bør du ikke køre bil eller betjene maskiner.
English: If induction occurs, this can give rise to reduced plasma concentrations of concomitantly administered medicinal products.
Danish: Hvis en sådan induktion forekommer, kan det medføre nedsatte plasmakoncentrationer af samtidigt administrerede medicinske produkter.
English: At 3 months, about an extra 10% of responders were seen in the Circadin treated group.
Danish: Efter 3 måneder blev der set ca. 10 % ekstra respondenter i den gruppe, der blev behandlet med Circadin.
English: The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly.
Danish: Absorptionen af oralt indtaget melatonin er fuldstændig hos voksne og kan være nedsat med op til 50 % hos ældre.
English: The safety and efficacy of Circadin in children aged 0 to 18 years has not yet been established.
Danish: Circadins sikkerhed og virkning hos børn i alderen 0-18 år er endnu ikke klarlagt.
English: You should swallow the tablet whole.
Danish: Du skal synke tabletterne hele.
English: Frequency not known: (cannot be established from the available data)
Danish: Hyppighed ikke kendt: (kan ikke fastsættes ud fra de tilgængelige data)
English: Angina pectoris, palpitations
Danish: Angina pectoris, palpitationer
English: Hypersensitivity reaction
Danish: Hypersensitiv reaktion
English: Lancashire BB10 2HW UK
Danish: Lancashire BB10 2HW Storbritannien
English: Not known: (Cannot be established from the available data)
Danish: Ukendt (Kan ikke fastsættes ud fra de tilgængelige data)
English: Date of latest renewal: 20 April 2012
Danish: Dato for første markedsføringstilladelse: 29. juni 2007 Dato for seneste fornyelse: 20. april 2012
English: Rationale for use
Danish: Rationale for brug
English: The clinical relevance of the finding is unknown.
Danish: Den kliniske relevans af dette kendes ikke.
English: The in vitro plasma protein binding of melatonin is approximately 60%.
Danish: In vitro plasmaproteinbindingen af melatonin er cirka 60 %.
English: Whether or not these active substances interfere with the dynamic or kinetic effects of Circadin or vice versa has not been studied.
Danish: Hvorvidt disse aktive stoffer forstyrrer de dynamiske eller kinetiske virkninger af Circadin eller omvendt er ikke undersøgt.
English: Somnolence was the most reported adverse event.
Danish: Somnolens var den oftest rapporterede bivirkning.
English: Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls.
Danish: Patienterne havde en signifikant nedsat total udskillelse af 6-sulfatoxymelatonin sammenlignet med kontrolpersonerne.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden ved dette lægemiddel.
English: If you forget to take your tablet, take another as soon as you remember, before going to sleep, or wait until it is time to take your next dose, then go on as before.
Danish: Hvis du glemmer at tage din tablet, skal du tage én, så snart du kommer i tanker om det, før du går i seng, eller vente til det er tid for næste dosis.
English: • Reduced number of white blood cells in the blood
Danish: • Nedsat antal hvide blodlegemer i blodet
English: • Reduced blood platelets, which increases risk of bleeding or bruising
Danish: • Nedsat antal blodplader, hvilket øger risikoen for blødning eller blå mærker
English: Tablets should be swallowed whole to maintain prolonged release properties.
Danish: Tabletterne skal sluges hele for at bevare egenskaberne, der medfører længerevarende frigivelse.
English: • Disorientation
Danish: • Desorientering
English: Do not drink alcohol before, during or after taking Circadin, because it reduces the effectiveness of Circadin.
Danish: Drik ikke alkohol før, under eller efter, du har taget Circadin, da det mindsker virkningen af Circadin.
English: • Vertigo (a feeling of dizziness or “spinning”)
Danish: • Vertigo (en følelse af svimmelhed, ”det hele snurrer rundt”)
English: The activity of melatonin at the MT1, MT2 and MT3 receptors is believed to contribute to its sleep-promoting properties, as these receptors (mainly MT1 and MT2) are involved in the regulation of circadian rhythms and sleep regulation.
Danish: Melatonins virkning på MT1, MT2- og MT3-receptorer menes at bidrage til dens søvnfremmende egenskaber, da disse receptorer (hovedsageligt MT1 og MT2) er involveret i reguleringen af døgnrytmen og søvnen.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal derefter fremsende PSUR'er i overensstemmelse med kravene på listen over EU- referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Frosst Ibérica, S.A. Vía Complutense, 140 Alcalá de Henares 28805 Madrid Spain
Danish: Frosst Ibérica, S.A. Vía Complutense, 140 Alcalá de Henares 28805 Madrid Spanien
English: Do not use this medicine after the expiry date which is stated on the carton (EXP).
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: EU/1/07/392/001 21 tablets EU/1/07/392/002 20 tablets EU/1/07/392/003 30 tablets EU/1/07/392/004 7 tablets
Danish: EU/1/07/392/001 21 tabletter EU/1/07/392/002 20 tabletter EU/1/07/392/003 30 tabletter EU/1/07/392/004 7 tabletter
English: In a clinical trial, there was clear evidence for a transitory pharmacodynamic interaction between Circadin and zolpidem one hour following co-dosing.
Danish: I et klinisk forsøg var der tydelige tegn på en forbigående dynamisk interaktion mellem Circadin og zolpidem én time efter dosering.
English: Currently available data are described in section 5.1.
Danish: Aktuelt tilgængelige data er beskrevet i pkt.
English: In addition, there were fewer dropouts in the active treatment group (9 patients; 15.0%) compared to the placebo group (21 patients; 32.3%).
Danish: Derudover var der færre frafaldne i gruppen med aktiv behandling (9 patienter; 15,0 %) sammenlignet med placebogruppen (21 patienter; 32,3 %).
English: Clearance of the active substance is expected within 12 hours after ingestion.
Danish: Clearance af det aktive stof forventes inden for 12 timer efter indtagelse.