FrancophonIA/ELRC3.0 huggingface dataset:
English: - Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A and MAO-B)
Danish: - Samtidig brug af entacapon og nonselektive monoaminoxidase (MAO-A og MAO-B)-hæmmere
English: For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid potential excessive weight decrease.
Danish: Hvis patienten får diarré, anbefales det at kontrollere vægten regelmæssigt for at undgå et eventuelt uforholdsmæssigt stort vægttab.
English: Fatigue, sweating increased, fall
Danish: Træthed, øget svedtendens, fald
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: Hepatitis with mainly cholestatic features (see section 4.4.)
Danish: Leverbetændelse hovedsagelig kolestase (se pkt.4.4)
English: Isolated cases of rhabdomyolysis have been reported.
Danish: Enkeltstående tilfælde af rhabdomyolyse er indrapporteret.
English: Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Danish: Undersøgelse II: Daglig ON tid (%) Entacapon (n=103)
English: Do not use Entacapone Teva during pregnancy or if you are breast-feeding.
Danish: Du må ikke tage Entacapone Teva under graviditet, eller hvis du ammer.
English: The peak concentration (Cmax) in plasma is usually reached about one hour after ingestion of a 200 mg entacapone tablet.
Danish: Den maksimale plasmakoncentration (Cmax) opnås ca. 1 time efter indtagelse af en 200 mg entacapon tablet.
English: As Entacapone Teva tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Danish: Da Entacapone Teva-tabletter skal tages sammen med andre levodopa-lægemidler, skal du også læse indlægssedlen for disse lægemidler omhyggeligt.
English: For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
Danish: Hvis patienten oplever progressiv anoreksi, asteni og vægttab inden for relativt kort tid, bør det overvejes at udføre en generel medicinsk evaluering inklusive undersøgelse af leverfunktionen.
English: Entacapone therapy should be administered cautiously to patients with ischemic heart disease.
Danish: Entacaponbehandling bør administreres med forsigtighed til patienter med iskæmisk hjertesygdom.
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, misfarvning af hud samt nældefeber.
English: The doses of other antiparkinsonian medicinal products may need to be adjusted when entacapone treatment is initiated.
Danish: Doseringen af andre antiparkinson lægemidler må muligvis justeres, når der startes behandling med entacapon.
English: Entacapone decreases the metabolic loss of levodopa to 3O-methyldopa (3-OMD) by inhibiting the COMT enzyme.
Danish: Entacapon nedsætter det metaboliske tab af levodopa til 3-Ometyldopa (3-OMD) via en inhibering (hæmning) af COMT-enzymet.
English: 2031GA Haarlem The Netherlands
Danish: 2031GA Haarlem Nederlandene
English: When considered necessary, withdrawal of entacapone and other dopaminergic treatment should proceed slowly, and if signs and/or symptoms occur despite a slow withdrawal of entacapone, an increase in levodopa dosage may be necessary.
Danish: Når det skønnes nødvendigt, skal behandlingsafbrydelse af entacapon og anden dopaminerg behandling ske langsomt, og hvis der opstår tegn og/eller symptomer på MNS eller rhabdomyolyse på trods af en langsom nedtrapning af entacapon, kan en øgning i levodopadosis være nødvendigt.
English: These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings.
Danish: Denne form for opførsel kaldes sygelig vane- og impulshandlinger og kan omfatte sygelig spilletrang, overdreven spisning eller brug af penge, unormal stor sexlyst eller øget antal sexuelle tanker og følelser.
English: The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of the treatment.
Danish: De hyppigste bivirkninger forårsaget af entacapon er relateret til øget dopaminerg aktivitet og optræder hyppigst i begyndelsen af behandlingen.
English: In repeated dose toxicity studies, anaemia most likely due to iron chelating properties of entacapone was observed.
Danish: I toksicitetsforsøg med gentagen dosering er anæmi observeret, hvilket sandsynligvis skyldes entacapons jernchelaterende egenskaber.
English: If you forget to take the Entacapone Teva tablet with your levodopa dose, you should continue the treatment by taking the next Entacapone Teva tablet with your next levodopa dose.
Danish: Hvis du har glemt at tage din Entacapone Teva-tablet sammen med din levodopadosis, genoptager du behandlingen ved at tage den næste Entacapone Teva-tablet sammen med den næste levodopadosis.
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 til levodopa relaterede bivirkninger såsom dyskinesier, kvalme, opkastning og hallucinationer er det ofte nødvendigt at justere levodopa doseringen inden for de første dage til uger efter start af entacaponbehandling.
English: Entacapone inhibits the COMT enzyme mainly in peripheral tissues.
Danish: Entacapon inhiberer primært COMT-enzymet i de perifere væv.
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 dyskinesier eller malignt neuroleptikasyndrom (MNS) er i sjældne tilfælde set hos patienter med Parkinsons sygdom.
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 substanser.
English: Entacapone Teva may make it harder for you to digest iron.
Danish: Entacapone Teva kan gøre det sværere at optage jern.
English: In single-dose studies in healthy volunteers, no interactions were observed between entacapone and imipramine or between entacapone and moclobemide.
Danish: I enkeltdosis kliniske forsøg med raske frivillige fandtes ikke interaktion mellem entacapon og imipramin eller entacapon og meclobemid.
English: Entacapone may aggravate levodopa-induced orthostatic hypotension.
Danish: Entacapon kan forværre levodopa-induceret ortostatisk hypotension.
English: (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Danish: * Bivirkningerne er sat i rækkefølge under overskrifterne efter frekvens, den hyppigt forekomne først, ved anvendelse af følgende konventionelle regler: 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, da ingen valide estimater har kunnet opnås i kliniske og epidemiologiske studier).
English: • The other ingredients in the tablet core are cellulose microcrystalline, povidone, starch pregelatinised, magnesium stearate and in the film-coating are poly(vinyl alcohol), talc, titanium dioxide (E171), macrogol, iron oxide yellow (E172), lecithin (soya), iron oxide red (E172).
Danish: - Øvrige indholdsstoffer i tabletkernen: cellulose, mikrokrystallinsk; povidon, stivelse, prægelatineret, magnesiumstearat og i filmovertrækket poly(vinylalkohol); talcum; titandioxid (E171); macrogol; jernoxid-gul (E172); lecithin, soja og jernoxid-rød (E172).
English: Insomnia, hallucinations, confusion, paroniria
Danish: Insomni, hallucinationer, konfusion, paroniria (mareridt)
English: Experience with Entacapone Teva in patients under 18 years is limited.
Danish: Der er begrænset erfaring med brug af Entacapone Teva til patienter under 18 år.
English: In animal studies entacapone was excreted in milk.
Danish: I dyreforsøg udskilles entacapon i modermælken.
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 1,7%).
English: Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors.
Danish: Entacapon tilhører en ny terapeutisk klasse, catechol-O-metyl-transferase (COMT)-hæmmere.
English: Oral use.
Danish: Peroral anvendelse.
English: Hence, the precautions valid for levodopa treatment should also be taken into account for entacapone treatment.
Danish: Derfor bør forsigtighedsregler vedrørende levodopabehandling overvejes i forbindelse med entacaponbehandling.
English: Skin, hair, beard and nail discolorations
Danish: Misfarvning af hud, hår, skæg og negle
English: Entacapone Teva taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Danish: Entacapone Teva taget sammen med levodopa kan nedsætte dit blodtryk, hvilket kan få dig til at føle dig ør i hovedet eller svimmel.
English: Elderly patients No dosage adjustment of entacapone is required for elderly patients.
Danish: Ældre patienter: Det er ikke nødvendigt at justere dosis hos ældre patienter.
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 effekt i dyreforsøg, hvor entacapon blev administreret i betydeligt højere doser end de terapeutisk anbefalede doser.
English: - Neuroleptic Malignant Syndrome (NMS) is a rare severe reaction to medicines used to treat disorders of the nervous system.
Danish: • malignt neuroleptikasyndrom (NMS) er en sjælden, men alvorlig bivirkning til medicin, der anvendes til behandling af forstyrrelser i nervesystemet.
English: Consequently, adverse dopaminergic reactions may be more frequent when entacapone is added to levodopa/benserazide treatment (see also section 4.8).
Danish: Derfor kan dopaminerge bivirkningsreaktioner forekomme hyppigere, hvis entacapon føjes til levodopa/benserazidbehandlingen (se ligeledes pkt.
English: Swensweg 5, 2031 GA Haarlem The Netherlands
Danish: Swensweg 5, 2031 GA Haarlem Nederlandene
English: Entacapone Teva tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Danish: Entacapone Teva-tabletter indeholder entacapon og bruges sammen med levodopa til behandling af Parkinsons sygdom.
English: • The active substance is entacapone.
Danish: - Aktivt stof: Entacapon.
English: inhibitors (e.g. phenelzine, tranylcypromine).
Danish: (f.eks. phenelzin, tranylcypromin).
English: The recommended dose of Entacapone Teva is one 200 mg tablet with each levodopa dose.
Danish: Den anbefalede dosis af Entacapone Teva er en 200 mg tablet sammen med hver levodopadosis.
English: Thus, control of INR is recommended when entacapone treatment is initiated for patients receiving warfarin.
Danish: Derfor anbefales kontrol af INR, når entacapon gives til patienter, der samtidig er i behandling med warfarin.
English: Entacapone Teva in association with levodopa may have major influence on the ability to drive and use machines.
Danish: Entacapone Teva sammen med levodopa kan i væsentlig grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Entacapone Teva.
Danish: Den højeste anbefalede dosis er 10 tabletter pr. dag, dvs. 2.000 mg Entacapone Teva.
English: Entacapone may, together with levodopa, cause dizziness and symptomatic orthostatism.
Danish: Entacapon kan sammen med levodopa forårsage svimmelhed og symptomatisk ortostatisme.
English: Renal impairment does not affect the pharmacokinetics of entacapone.
Danish: Nyreinsufficiens påvirker ikke entacapons farmakokinetiske egenskaber.
English: Women should not breast-feed during treatment with entacapone.
Danish: Kvinder bør derfor ikke amme ved behandling med entacapon.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
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: - A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Danish: - Malignt neuroleptikasyndrom (MNS) og/eller ikke-traumatisk rhabdomyolyse i anamnesen.
English: The safety and efficacy of Entacapone Teva in children below age 18 have not been established.
Danish: Pædiatrisk population: Sikkerhed og virkning af Entacapone Teva hos børn under 18 år er ikke klarlagt.
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 hyperthermi er karakteriseret ved muskelsymptomer (stivhed, myocloni, rysten), ændring af mental status (fx. agitation, konfusion, koma), hyperthermi, autonomisk dysfunktion (tachycardi, labilt blodtryk) og forhøjet serumkreatinfosfokinase.
English: One 200 mg tablet is taken with each levodopa/dopa decarboxylase inhibitor dose.
Danish: En 200 mg tablet tages sammen med hver dosis af levodopa/dopa-decarboxylasehæmmer.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt
English: The substance is subject to extensive first-pass metabolism.
Danish: Entacapon har en betydelig first pass metabolisme.
English: What you need to know before you take Entacapone Teva Do NOT take Entacapone Teva
Danish: Det skal du vide, før du begynder at tage Entacapone Teva Tag ikke Entacapone Teva
English: Entacapone is always given as an adjunct to levodopa treatment.
Danish: Entacapon administreres altid som adjuvant til levodopabehandling.
English: Entacapone enhances the effects of levodopa.
Danish: Entacapon forøger virkningen af levodopa.
English: Urine may be discoloured reddish-brown by entacapone, but this is a harmless phenomenon.
Danish: Urinen kan blive misfarvet og blive farvet rødbrun af entacapon, men denne bivirkning er harmløs.
English: Österreich ratiopharm Arzneimittel VertriebsGmbHTel: +43/1/97007-0
Danish: Ratiopharm Arzneimittel Vertriebs - GmbH Tel: +43/1/97007-0
English: Package leaflet: information for the user Entacapone Teva 200 mg film-coated tablets entacapone
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Entacapone Teva 200 mg filmovertrukne tabletter entacapon
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 levodopa-relaterede 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: Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
Danish: Forværring af Parkinsons sygdom, svimmelhed, dystoni, hyperkinesi
English: Do not stop taking Entacapone Teva unless your doctor tells you to.
Danish: Du må kun ophøre med at tage Entacapone Teva, hvis din læge har sagt det.
English: Since the introduction into the market, isolated cases of NMS have been reported, especially following abrupt reduction or discontinuation of entacapone and other concomitant dopaminergic medicinal products.
Danish: Efter markedsføring er indrapporteret enkeltstående tilfælde af MNS, især efter pludselig nedsættelse eller afbrydelse af entacapon og andre samtidige dopaminerge lægemidler.
English: Light brown, biconvex, ellipse-shaped film-coated tablets with approximately 18 mm length and 10 mm width, embossed ‘E200' on one side, plain on the other side.
Danish: Lysebrune, bikonvekse, ellipseformede, filmovertrukne tabletter med en længde på ca. 18 mm og en bredde på ca. 10 mm, med ”E200” præget på den ene side og uden prægning på den anden side.
English: For the characteristics of NMS see Section 4 Possible side effects.
Danish: Se symptomer på NMS i punkt 4 Bivirkninger.
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 Teva 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 Comtessi kombination med levodopa.
English: Be particularly careful when you drive or when you use tools or machinery.
Danish: Du skal være meget forsigtig, når du kører bil eller betjener maskiner.
English: Usually side effects caused by Entacapone Teva are mild to moderate.
Danish: De hyppigste bivirkninger, der skyldes brug af Entacapone Teva, er milde til moderate.
English: In two phase III double-blind studies in a total of 376 patients with Parkinson's disease and end-ofdose motor fluctuations, entacapone or placebo was given with each levodopa/dopa decarboxylase inhibitor dose.
Danish: I to fase III dobbelt-blindede undersøgelser blev entacapon eller placebo givet med hver dosis af levodopa/dopa-decarboxylasehæmmere til i alt 376 patienter med Parkinsons sygdom og end-of-dose fluktuationer.
English: In clinical studies, adverse dopaminergic reactions, 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 forsøg 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: 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 2000 mg entacapon.
English: The prescribing information for these levodopa preparations is applicable to their concomitant use with entacapone.
Danish: Tilsvarende ordinationsinformation gælder for disse levodopapræparater med hensyn til ordination sammen med entacapon.
English: Entacapone Teva film-coated tablets are light brown, biconvex ellipse-shaped with approximately 18 mm length and 10 mm width, embossed with “E200” on one side and plain on the other side.
Danish: Entacapone Teva 200 mg filmovertrukne tabletter er lysebrune, bikonvekse, ellipseformede tabletter med en længde på ca. 18 mm og en bredde på ca. 10 mm, præget med ”E200” på den ene side og uden prægning på den anden side.
English: Ischemic 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
English: 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets 175 film-coated tablets
Danish: 30 filmovertrukne tabletter 60 filmovertrukne tabletter 100 filmovertrukne tabletter 175 filmovertrukne tabletter
English: 60 film-coated tablets 100 film-coated tablets 175 film-coated tablets
Danish: 60 filmovertrukne tabletter 100 filmovertrukne tabletter 175 filmovertrukne tabletter
English: Common (may affect up to 1 in 10 people): - Excessive movements (hyperkinesias), worsening of symptoms of Parkinson´s disease,
Danish: • overdrevne bevægelser (hyperkinesier), forværring af symptomer på Parkinsons sygdom,
English: Usually the adverse reactions caused by entacapone are mild to moderate.
Danish: Sædvanligvis er bivirkninger forårsaget af entacapon milde til moderate.
English: Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and 4.4).
Danish: Der bør udvises forsigtighed, når disse produkter anvendes samtidigt med entacapon (se pkt.
English: Entacapone Teva is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Danish: Entacapone Teva tages sammen med medicin, der indeholder levodopa (enten levodopa/carbidopapræparater eller levodopa/benserazid-præparater).
English: Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations 5-10% more than from standard levodopa/carbidopa preparations.
Danish: Entacapon øger biotilgængeligheden af levodopa for standardformuleringer af levodopa/benserazid 5-10% mere end for standardformuleringer af levodopa/carbidopa.
English: However, a longer dosing interval may be considered for patients who are receiving dialysis therapy.
Danish: Imidlertid bør forlænget doseringsinterval overvejes for patienter i dialysebehandling.
English: However, for patients who are receiving dialysis therapy, a longer dosing interval may be considered (see section 5.2).
Danish: Kun hos patienter i dialysebehandling bør det overvejes at forlænge doseringsintervallet (se pkt.
English: Food does not affect the absorption of entacapone to any significant extent.
Danish: Fødeindtagelse ændrer ikke signifikant absorptionen af entacapon.
English: Diarrhoea, abdominal pain, dry mouth, constipation, vomiting
Danish: Diarré, abdominalsmerter, mundtørhed, forstoppelse, opkastning
English: Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations slightly (5-10%) more than from standard levodopa/carbidopa preparations.
Danish: Entacapon øger biotilgængeligheden af levodopa for levodopa/benserazidstandardformuleringer en smule mere (5-10%) end for levodopa/carbidopastandardformuleringer.