FrancophonIA/ELRC3.0 huggingface dataset:
English: Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
Danish: Dyskinesier (27%), kvalme (11%), diarré (8%), abdominal smerter (7%) og mundtørhed (4,2%) blev rapporteret signifikant hyppigere med entacapon end placebo i poolede data fra kliniske studier, hvor 406 patienter har fået den aktive medicin, og 296 patienter har fået placebo.
English: In animal studies entacapone was excreted in milk.
Danish: I dyrestudier udskilles entacapon i mælken.
English: If you forget to take Comtan
Danish: Hvis du har glemt at tage Comtan
English: Brownish-orange, oval, biconvex film-coated tablet with “Comtan” engraved on one side.
Danish: Brun-orange, oval, bikonveks, filmovertrukket tablet med ”Comtan” præget på den ene side.
English: Some of the adverse reactions, such as dyskinesia, nausea, and abdominal pain, may be more common with the higher doses (1,400 to 2,000 mg per day) than with the lower doses of entacapone.
Danish: Visse af disse bivirkninger, som dyskinesier, kvalme og abdominal smerter, kan være hyppigere ved højere doser (1.400-2.000 mg per dag) end ved lavere doser af entacapon.
English: Experience with Comtan in patients under 18 years is limited.
Danish: Der er begrænset erfaring med brug af Comtan til patienter under 18 år.
English: Suddenly stopping Comtan and other medicines to treat Parkinson's disease may result in unwanted side effects.
Danish: Pludselig stop med brug af Comtan og anden medicin til behandling af Parkinsons sygdom kan give uønskede bivirkninger.
English: Of the metabolites found in urine only about 1% have been formed through oxidation.
Danish: Af de metabolitter, der findes i urinen, er kun ca. 1%
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtan and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Danish: Malignt neuroleptika syndrom (MNS) er en alvorlig, men sjælden reaktion på visse lægemidler, som især kan forekomme, hvis behandling med Comtan og andre lægemidler til behandling af Parkinsons sygdom pludseligt stoppes, eller hvis dosis pludseligt nedsættes.
English: There are three different pack sizes (bottles containing 30, 60, or 100 tablets).
Danish: Der findes tre forskellige pakningsstørrelser (beholdere med 30, 60 eller 100 tabletter).
English: As Comtan tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Danish: Da Comtan-tabletter skal tages sammen med andre levodopa-lægemidler, skal du også læse indlægssedlen for disse lægemidler omhyggeligt.
English: Therefore, the use of Comtan in children or adolescents cannot be recommended.
Danish: Brug af Comtan frarådes derfor til børn eller unge.
English: Do not take Comtan
Danish: Tag ikke Comtan:
English: Your doctor may advise you to slowly discontinue the treatment with Comtan and other medicines to treat Parkinson's disease.
Danish: Din læge kan råde dig til langsomt at stoppe behandlingen med Comtan og andre lægemidler til behandling af Parkinsons sygdom.
English: If you forget to take the Comtan tablet with your levodopa dose, you should continue the treatment by taking the next Comtan tablet with your next levodopa dose.
Danish: Hvis du har glemt at tage din Comtan-tablet sammen med din levodopadosis, genoptager du behandlingen ved at tage den næste Comtan-tablet sammen med den næste levodopadosis.
English: hydrogenated vegetable oil, magnesium stearate.
Danish: hydrogeneret vegetabilsk olie og magnesiumstearat.
English: The safety and efficacy of Comtan in children below age 18 have not been established.
Danish: Comtans sikkerhed og virkning hos børn i alderen under 18 år er ikke klarlagt.
English: Comtan 200 mg [carton only]
Danish: Comtan 200 mg [kun karton]
English: Other medicines and Comtan
Danish: Brug af anden medicin sammen med Comtan
English: Comtan taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Danish: Comtan taget sammen med levodopa kan nedsætte dit blodtryk, hvilket kan få dig til at føle dig ør i hovedet eller svimmel.
English: What Comtan contains - The active substance is entacapone.
Danish: Comtan indeholder - Aktivt stof: Entacapon.
English: If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Danish: Hvis entacaponbehandlingen afbrydes, er det nødvendigt at justere doseringen af de andre antiparkinsonpræparater, specielt levodopa, for at opnå tilstrækkelig kontrol med symptomerne.
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 4 µM).
Danish: Data fra in vitro studier, hvor der er anvendt humant levermikrosomal materiale, indikerer at entacapon hæmmer cytokrom P450 2C9 (IC50 ~ 4 M).
English: Uncommon (may affect up to 1 in 100 people): • Heart attack.
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 personer): • hjerteanfald.
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-Omethyldopa (3-OMD) via en inhibering af COMT-enzymet.
English: - The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium,
Danish: - Øvrige indholdsstoffer: Mikrokrystallinsk cellulose, mannitol, croscarmellosenatrium,
English: Hence, to reduce levodopa-related dopaminergic adverse reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment.
Danish: For at reducere de levodopa-relaterede bivirkninger, såsom dyskinesier, kvalme, opkastning og hallucinationer, er det ofte nødvendigt at justere levodopadoseringen inden for de første dage til uger efter start af entacaponbehandling.
English: Comtan in association with levodopa may have a major influence on the ability to drive and use machines.
Danish: Comtan sammen med levodopa kan i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtan.
Danish: Den højeste, anbefalede dosis er 10 tabletter pr. dag, dvs. 2.000 mg Comtan.
English: The acute symptoms and signs in these cases of overdose included confusion, decreased activity, somnolence, hypotonia, skin discolouration and urticaria.
Danish: De akutte symptomer og tegn i disse tilfælde af overdosering var konfusion, nedsat aktivitet, døsighed, hypotoni, misfarvet hud samt nældefeber.
English: Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors.
Danish: Entacapon tilhører en ny terapeutisk klasse, catechol-O-methyl-transferase (COMT)-hæmmere.
English: At therapeutic concentrations, entacapone does not displace other extensively bound substances (e.g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any significant extent by any of these substances at therapeutic or higher concentrations.
Danish: Ved terapeutiske koncentrationer displacerer entacapon ikke andre substanser med høj proteinbinding (f.eks. warfarin, salicylsyre, phenylbutazon eller diazepam), og entacapon bliver heller ikke (hverken i terapeutisk eller højere koncentration) i nogen signifikant grad displaceret af disse stoffer.
English: • discolouration of the skin, hair, beard and nails.
Danish: • misfarvning af hud, hår, skæg og negle.
English: The recommended dose of Comtan is one 200 mg tablet with each levodopa dose.
Danish: Den anbefalede dosis af Comtan er en 200 mg tablet sammen med hver levodopadosis.
English: - The film-coating contains hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171), magnesium stearate.
Danish: - Filmovertræk: Hypromellose, polysorbat 80, glycerol 85%, saccharose, gul jernoxid (E172), rød jernoxid (E172), titandioxid (E171) og magnesiumstearat.
English: Comtan tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Danish: Comtan-tabletter indeholder entacapon og bruges sammen med levodopa til behandling af Parkinsons sygdom.
English: Each tablet contains 1.82 mg sucrose.
Danish: Hver tablet indeholder 1,82 mg saccharose.
English: Regarding reproduction toxicity, decreased foetal weight and a slightly delayed bone development were noticed in rabbits at systemic exposure levels in the therapeutic range.
Danish: Mht. studier af reproduktionstoksicitet sås lavere fostervægt og let forsinket knogleudvikling hos kaniner ved systemiske eksponeringsniveauer i det terapeutiske område.
English: Insomnia, hallucinations, confusion, paroniria
Danish: Søvnmangel, hallucinationer, konfusion, paroniria (mareridt)
English: • rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa,
Danish: • rimiterol, isoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, methyldopa, apomorphin
English: Croscarmellose sodium Hydrogenated vegetable oil Magnesium stearate
Danish: Croscarmellosenatrium Hydrogeneret vegetabilsk olie Magnesiumstearat
English: • harmless reddish-brown discolouration of urine.
Danish: • harmløs farveændring af urinen.
English: Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/galactose-malabsorption og sucrase-isomaltase-mangel.
English: 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Danish: 30 filmovertrukne tabletter 60 filmovertrukne tabletter 100 filmovertrukne tabletter
English: What you need to know before you take Comtan
Danish: Det skal du vide, før du begynder at tage Comtan
English: When stopping, your doctor may need to re-adjust the dosage of your other medicines to treat Parkinson's disease.
Danish: Hvis du stopper kan det være nødvendigt for din læge at justere doseringen af din anden medicin til behandling af Parkinsons sygdom.
English: If you take more Comtan 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 Comtan, skal du straks henvende dig til din læge, på apoteket eller nærmeste hospital.
English: Microcrystalline cellulose Mannitol
Danish: Cellulose, mikrokrystallinsk Mannitol
English: White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60 or 100 tablets.
Danish: Hvid high-density polyethylen (HDPE) beholder med hvidt forseglet polypropylen (PP) låg indeholdende 30, 60 eller 100 tabletter.
English: Comtan is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Danish: Comtan tages sammen med medicin, der indeholder levodopa (enten levodopa/carbidopa præparater eller levodopa/benserazid præparater).
English: The maximum recommended dose is 200 mg ten times daily, i.e. 2,000 mg of entacapone.
Danish: Den maksimale anbefalede dosis er 200 mg 10 gange daglig, hvilket er 2.000 mg entacapon.
English: Comtan has no effect on relieving the symptoms of Parkinson's disease unless taken with levodopa.
Danish: Comtan har kun lindrende virkning på symptomerne fra Parkinsons sygdom, hvis det tages sammen med levodopa.
English: Table 1* Adverse drug reactions
Danish: Tabel 1* Bivirkninger
English: Usually side effects caused by Comtan are mild to moderate.
Danish: De hyppigste bivirkninger, der skyldes brug af Comtan, er milde til moderate.
English: Table 2 Daily ON time (Mean ± SD)
Danish: Daglig ON tid (middelværdi SD)
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 Comtan in association with levodopa.
Danish: Patienter og omsorgspersoner skal gøres opmærksomme på, at symptomer på patologiske vane- og impulshandlinger inklusive 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 Comtan i kombination med levodopa.
English: It is characterised by stiffness, muscle twitching, shaking, agitation, 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: To reduce levodopa-related dopaminergic adverse reactions, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment, according to the clinical condition of the patient (see sections 4.2 and 4.8).
Danish: For at nedsætte de levodoparelaterede bivirkninger vil det ofte være nødvendigt at justere levodopadoseringen inden for de første dage eller uger efter starten på entacaponbehandlingen afhængig af patientens kliniske tilstand (se pkt.
English: Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)
Danish: Glycerol 85% Saccharose Gul jernoxid (E172) Rød jernoxid (E172) Titandioxid (E171) Magnesiumstearat
English: Amber glass bottles (hydrolytic class III) with white tamper-resistant polypropylene closures containing 30, 60 or 100 tablets.
Danish: Gyldenbrune glasflasker (hydrolytisk class III) med hvide, forseglede låg af polypropylen indeholdende 30, 60 eller 100 tabletter.
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-methyl transferase (COMT), f.eks. rimiterol, isoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfamethyldopa og apomorphin (se pkt.
English: Comtan tablets contain sucrose.
Danish: Comtan-tabletterne indeholder saccharose.
English: • Comtan taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
Danish: • Comtan 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: Comtan aids levodopa in relieving the symptoms of Parkinson's disease.
Danish: Comtan understøtter levodopa og lindrer derved symptomerne på Parkinsons sygdom.
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 er kontraindiceret (se pkt.
English: Diarrhoea, abdominal pain, dry mouth, constipation, vomiting
Danish: Diarré, abdominal smerter, mundtørhed, forstoppelse, opkastning
English: See Section 4 Possible side effects for the characteristics of NMS;
Danish: Se symptomer på MNS i punkt 4 Bivirkninger;
English: What Comtan looks like and contents of the pack Comtan 200 mg film-coated tablets are brownish-orange, oval tablets with “Comtan” engraved on one side.
Danish: Comtan 200 mg filmovertrukne tabletter er brun-orange, ovale tabletter mærket med ”Comtan” på den ene side.
English: Label Orion Corporation
Danish: Orion Corporation
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 Comtan in association with levodopa (see section 4.4).
Danish: Patologiske vane- og impulshandlinger: 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 Comtan i kombination med levodopa (se pkt.
English: Marketing Authorisation Holder Orion Corporation Orionintie 1
Danish: Indehaver af markedsføringstilladelsen Orion Corporation
English: How to take Comtan
Danish: Sådan skal du tage Comtan
English: In addition, Comtan taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Danish: Comtan taget sammen med levodopa kan endvidere gøre dig meget søvnig eller af og til få dig til pludseligt at falde i søvn.
English: CI95% 45 min, 1 h 56 Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Danish: Undersøgelse II: Daglig ON tid (%) Entacapon (n=103)
English: Urticaria
Danish: Vægttab
English: • if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtan);
Danish: Kontakt din læge eller apotekspersonalet, som kan undersøge, om din medicin kan tages sammen med Comtan;
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 via det nationale rapporteringssystem anført i Appendiks V.
English: 1 tablet contains 200 mg of entacapone.
Danish: 1 tablet indeholder 200 mg entacapon.
English: Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Danish: Entacapon i forbindelse med levodopa er i isolerede tilfælde, blevet sat i forbindelse med udtalt træthed (somnolens) i dagtimerne og episoder, hvor patienten pludselig falder i søvn.
English: SN:
Danish: PC:
English: Comtan 200 mg film-coated tablets
Danish: Comtan 200 mg filmovertrukne tabletter
English: Comtan 200 mg film-coated tablets entacapone
Danish: Comtan 200 mg filmovertrukne tabletter entacapon
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: Ischaemic heart disease events other than myocardial infarction (e.g. angina pectoris)
Danish: Andre tilfælde af iskæmisk hjertesygdom end myokardieinfarkt (f.eks. angina pectoris) Ikke almindelig Myokardieinfarkt Mave-tarm-kanalen Meget almindelig: Kvalme Almindelig:
English: Renal and urinary disorders Very common:
Danish: Nyrer og urinveje Meget almindelig: Farveændring af urin Almene symptomer og reaktioner på administrationsstedet Almindelig:
English: Comtan taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Danish: Samtidig brug af Comtan og levodopa kan gøre dig mere sløv, og nogen gange kan du pludseligt falde i søvn.
English: maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterol, 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, herunder MAO-A-hæmmere, tricykliske antidepressiva, noradrenalin re-uptake hæmmere såsom 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: Comtan contains sucrose Comtan tablets contain a sugar called sucrose.
Danish: Comtan-tabletter indeholder sukkerstoffet saccharose.
English: What Comtan is and what it is used for What you need to know before you take Comtan How to take Comtan
Danish: Det skal du vide, før du begynder at tage Comtan Sådan skal du tage Comtan Bivirkninger
English: Hepatitis with mainly cholestatic features (see section 4.4) Skin and subcutaneous tissue disorders Rare:
Danish: Leverbetændelse hovedsagelig kolestase (se pkt.4.4)
English: Urine discolouration
Danish: • hududslæt
English: Isolated cases of rhabdomyolysis have been reported.
Danish: Enkeltstående tilfælde af rabdomyolyse er indrapporteret.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom alder og helbred.
English: This is a summary of the European public assessment report (EPAR) for Alprolix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Alprolix.
English: A risk management plan has been developed to ensure that Alprolix is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Alprolix anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Alprolix's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Alprolix opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Other information about Alprolix
Danish: Andre oplysninger om Alprolix
English: It can be used in patients of all ages.
Danish: Alprolix kan anvendes til patienter i alle aldre.
English: What measures are being taken to ensure the safe and effective use of Alprolix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Alprolix?
English: Patients or their carers may be able to inject Alprolix themselves at home once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsgiver har mulighed for selv at give Alprolix i hjemmet efter at have fået passende instruktion.
English: The active substance in Alprolix, eftrenonacog alfa, works in the body in the same way as human factor IX.
Danish: Det aktive stof i Alprolix, eftrenonacog alfa, virker på samme måde i kroppen som kroppens egen faktor IX.
English: Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Alprolix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2007.
Danish: Da antallet af patienter med hæmofili B er lavt, betragtes sygdommen som "sjælden", og Alprolix blev udpeget som "lægemiddel til sjældne sygdomme" den 8. juni 2007.
English: Hypersensitivity (allergic) reactions are seen rarely with Alprolix and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Danish: Allergiske reaktioner ses sjældent med Alprolix, og de omfatter: hævelse, brændende og stikkende fornemmelse på injektionsstedet, kulderystelser, hedeture, kløende udslæt, hovedpine, nældefeber, lavt blodtryk, sløvhed, kvalme og opkastning, rastløshed, hurtig hjerterytme, trykken for brystet og hvæsende vejrtrækning.
English: The full EPAR for Alprolix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Alprolix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Alprolix and what is it used for?
Danish: Hvad er Alprolix, og hvad anvendes det til?
English: Why is Alprolix approved?
Danish: Hvorfor blev Alprolix godkendt?