FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro data: Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Danish: In-vitro data: Entacapon bindes til humant albumin - bindingssted II, der også binder flere andre lægemidler, inklusive diazepam og ibuprofen.
English: Unchanged carbidopa accounts for 30% of the total urinary excretion.
Danish: Uændret carbidopa udgør 30% af det, der totalt udskilles i urinen.
English: Correspondingly, the decrease in daily OFF time was 24% in the entacapone group and 0% in the placebo group.
Danish: Tilsvarende var reduktionen af daglig ”off-tid” 24% i entacapongruppen og 0% i placebogruppen.
English: In the second study, the mean proportion of daily ON time increased by 4.5% (CI95% 0.93%, 7.97%) from baseline.
Danish: I det andet studie sås en øgning i den gennemsnitlige andel af daglig ”on-tid” med 4,5% (CI95% 0,93%, 7,97%) fra baseline.
English: Weight decreased*, decreased appetite*
Danish: Vægttab*, nedsat appetit*
English: The adequacy of the respiratory, circulatory and renal systems should be carefully monitored and appropriate supportive measures employed.
Danish: Respiration, kredsløb og nyrefunktion bør omhyggeligt overvåges og understøttende tiltag iværksættes.
English: The CHMP recommends that the terms of the Marketing Authorisations should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-tilladelserne ændres.
English: No pharmacodynamic interactions were observed.
Danish: Der blev ikke observeret nogen farmakodynamiske interaktioner.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: 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 estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Danish: Bivirkningerne er opdelt efter hyppighed med de hyppigste først og efter følgende konvention: 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 incidence rates of myocardial infarction and other ischemic heart disease events (0.43% and 1.54%, respectively) are derived from an analysis of 13 double-blind studies involving 2082 patients with end-of-dose motor fluctuations receiving entacapone.
Danish: **Hyppigheden af myokardieinfarkt og andre iskæmiske hjertesygdomme (henholdsvis 0,43% og 1,54%) stammer fra en analyse af 13 dobbeltblinde studier med 2.082 patienter med end-of-dose motoriske fluktuationer, der fik entacapon.
English: The following side effects have also been reported: - hepatitis (inflammation of the liver) - itching
Danish: Følgende bivirkninger er også indberettet: - leverbetændelse (hepatitis) - kløe
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og æsken.
English: However, no interaction with carbidopa has been observed with the recommended treatment schedule (200 mg of entacapone up to 10 times daily).
Danish: Der er imidlertid ikke observeret interaktioner med carbidopa i det anbefalede doseringsskema (200 mg entacapon op til 10 gange dagligt).
English: Entacapone in high doses may affect the absorption of carbidopa.
Danish: Entacapon i høje doser kan påvirke absorptionen af carbidopa.
English: Entacapone is almost completely metabolized prior to excretion via urine (10 to 20%) and bile/faeces (80 to 90%).
Danish: Entacapon metaboliseres næsten fuldstændigt før udskillelse via urinen (10-20%) og via galde og fæces (80-90%).
English: 2D barcode carrying the unique identifier included [carton only]
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator [kun karton]
English: Entacapone is a reversible, specific and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa.
Danish: Entacapon er en reversibel,specifik og hovedsagelig perifert virkende COMT-hæmmer, beregnet til samtidig administrering med levodopa.
English: Neuroleptic malignant syndrome*
Danish: Malignt neuroleptikasyndrom*
English: Hospitalisation is advised and general supportive measures should be employed with immediate gastric lavage and repeated doses of charcoal over time.
Danish: Sygehusindlæggelse anbefales, og generel understøttende behandling bør igangsættes med umiddelbar mavetømning og gentagne doser med medicinsk kul over tid.
English: Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19); see section 4.5.
Danish: Entacapon udviser lav eller ingen hæmning af andre typer af P450 isoenzymer (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A og CYP2C19); se pkt.
English: Entacapone may in some cases cause also discolouration of e.g. skin, nail, hair and sweat.
Danish: Entacapon kan i nogle tilfælde også medføre misfarvning af f.eks. hud, negle, hår og sved.
English: Therefore, any abrupt dose reduction or withdrawal of levodopa should be carefully observed, particularly in patients who are also receiving neuroleptics.
Danish: Pludselig dosisreduktion eller seponering af levodopa bør derfor følges nøje, specielt hos patienter som desuden får neuroleptika.
English: Carbidopa is metabolized to two main metabolites which are excreted in the urine as glucuronides and unconjugated compounds.
Danish: Carbidopa metaboliseres til to hovedmetabolitter, der udskilles i urinen som glukoronider og ikkekonjugerede komponenter.
English: Consequently the clinical response to each dose of levodopa is enhanced and prolonged.
Danish: Som et resultat af dette forstærkes og forlænges den kliniske respons af hver levodopadosis.
English: Label Orion Corporation
Danish: Etiket Orion Corporation
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: In case of an overdose you may feel confused or agitated, your heart rate may be slower or faster than normal or the colour of your skin, tongue, eyes or urine may change.
Danish: I tilfælde af en overdosis kan du blive forvirret eller urolig, din puls kan blive hurtigere eller langsommere end normalt eller farven på din hud, din tunge, i dine øjne eller din urin kan ændres.
English: This is translated to a mean increase of 35 min in the daily ON time.
Danish: Dette svarer til en gennemsnitlig øgning i daglig ”on-tid” på 35 minutter.
English: Dopamine dysregulation syndrome was included in five adverse drug reaction reports during this PSUR reporting period.
Danish: Dopaminergt dysreguleringssyndrom blev inkluderet i fem bivirkningsrapporteringer i løbet af denne PSUR-periode.
English: This may hasten the elimination of entacapone in particular by decreasing its absorption/reabsorption from the GI tract.
Danish: Dette kan specielt øge eliminationen af entacapon ved at reducere absorptionen/reabsorptionen fra mave-tarmkanalen.
English: - Concomitant administration of antipsychotics with dopamine receptor-blocking properties, particularly D2 receptor antagonists should be carried out with caution, and the patient carefully observed for loss of antiparkinsonian effect or worsening of parkinsonian symptoms.
Danish: - Samtidig indgift af antipsykotiske lægemidler med dopaminreceptor-blokkerende egenskaber, specielt D2-receptorantagonister bør ske med forsigtighed, og patienten bør følges omhyggeligt for aftagende antiparkinson-virkning eller forværring af parkinson-symptomer.
English: These include: - medicines used to treat depression such as moclobemide, amitriptyline, desipramine,
Danish: Disse er: - medicin, der bruges til behandling af depressioner, f.eks. moclobemid, amitriptylin, desipramin,
English: time with and without entacapone was recorded in home-diaries by patients.
Danish: Daglig ”on-tid” (timer) med eller uden entacapon blev registreret i dagbøger af patienterne.
English: Interactions between entacapone and imipramine and between entacapone and moclobemide have been investigated in single dose studies in healthy volunteers.
Danish: Interaktioner mellem entacapon og imipramin og mellem entacapon og moclobemid har været undersøgt i enkeltdosisstudier hos raske frivillige.
English: The daily dose of levodopa can be reduced by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Danish: Den daglige dosis af levodopa kan reduceres ved at øge dosisintervallerne og/eller ved at reducere levodopamængden pr. dosis, afhængigt af patientens kliniske tilstand.
English: Regarding reproduction toxicity of entacapone, decreased foetal weight and a slightly delayed bone development were noticed in rabbits treated at systemic exposure levels in the therapeutic range.
Danish: Med hensyn til reproduktionstoksicitet for entacapon er der observeret lavere fostervægt og en let forsinket knogleudvikling hos kaniner ved systemiske eksponeringsniveauer i det terapeutiske område.
English: Therefore, caution should be exercised when driving or using machines.
Danish: Derfor skal der udvises forsigtighed ved bilkørsel samt betjening af maskiner.
English: Dose adjustment of the antihypertensive agent may be required.
Danish: Dosisjustering af antihypersentivt lægemiddel kan være nødvendigt.
English: Due to short elimination half-lives, no true accumulation of levodopa or entacapone occurs on repeated administration.
Danish: Pga. kort halveringstid ved elimination opstår der reelt ingen akkumulering af levodopa eller entacapon ved gentagen indgift.
English: Correspondingly, the daily OFF time decreased by 18% on entacapone and by 5% on placebo.
Danish: Tilsvarende blev den daglige ”off-tid” reduceret med 18% med entacapon og 5% med placebo.
English: General characteristics of the active substances
Danish: De aktive indholdsstoffers generelle egenskaber
English: - Severe hepatic impairment.
Danish: - har en alvorlig leversygdom.
English: No pharmacodynamic interactions have been observed.
Danish: Der er ikke set farmakodynamiske interaktioner.
English: In the first study, entacapone increased the mean daily ON time by 1 h 20 min (CI 95% 45 min, 1 h 56 min) from baseline.
Danish: I det første studie øgede entacapon gennemsnitligt ”on-tiden” med 1 time og 20 minutter (CI95% 45 minutter, 1 time 56 minutter) fra baseline.
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 lever mikrosomale præparationer, indikerer, at entacapon hæmmer cytokrom P450 2C9 (IC50 ~ 4 M).
English: Each tablet is to be taken orally either with or without food (see section 5.2).
Danish: Hver tablet skal indtages peroralt, med eller uden føde (se pkt.
English: Carbidopa is absorbed and eliminated slightly slower compared with levodopa.
Danish: Carbidopa absorberes og elimineres noget langsommere end levodopa.
English: Taking into account the PRAC Assessment Report on the PSUR for carbidopa/entacapone/levodopa, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en for carbidopa/entacapon/levodopa er CHMP nået frem til følgende videnskabelige konklusioner:
English: Ischemic heart disease events other than myocardial infarction (e.g. angina pectoris)**, irregular heart rhythm
Danish: Iskæmisk hjertesygdom undtagen myokardieinfarkt (f.eks. angina pectoris)**, uregelmæssig hjerterytme
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Carbidopa and entacapone were excreted in milk in animals but is not known whether they are excreted in human breast milk.
Danish: Carbidopa og entacapon udskilles i mælken hos dyr, men det vides ikke om stofferne udskilles i human mælk.
English: Preclinical data of levodopa, carbidopa and entacapone, tested alone or in combination, revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Danish: Prækliniske data for levodopa, carbidopa og entacapon testet alene eller i kombination viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: According to the current understanding, the symptoms of Parkinson's disease are related to depletion of dopamine in the corpus striatum.
Danish: I henhold til gældende opfattelse er symptomer ved Parkinsons sygdom knyttet til manglen på dopamin i corpus striatum.
English: Consult your doctor if you are currently taking: - antipsychotics (medicines used to treat psychosis) - a medicine which may cause low blood pressure when rising from a chair or bed.
Danish: Tal med din læge, hvis du tager: - medicin mod psykoser (antipsykotika) - medicin, der kan bevirke, at du får lavt blodtryk, når du rejser dig fra en stol eller seng.
English: For severe hepatic impairment see section 4.3.
Danish: Ved alvorligt nedsat leverfunktion se pkt 4.3.
English: Elderly: When given without carbidopa and entacapone, the absorption of levodopa is greater and elimination is slower in elderly than in young people.
Danish: Ældre: Absorptionen af levodopa, indgivet uden carbidopa og entacapon, er større og elimineringen langsommere hos ældre end hos yngre personer.
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: If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel fully awake again before driving or doing anything else that requires you to be alert.
Danish: Hvis du føler dig meget søvnig, eller hvis du mærker, at du pludselig falder i søvn, skal du vente med at køre bil, til du er helt vågen.
English: Since the introduction of entacapone 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 at entacapon er kommet på markedet, er der rapporteret om enkeltstående tilfælde af MNS, især i forbindelse med pludselig reducering eller afbrydelse af behandlingen med entacapon og anden samtidig behandling med dopaminerge lægemidler.
English: Absorption/distribution: There are substantial inter- and intra-individual variations in the absorption of levodopa, carbidopa and entacapone.
Danish: Absorption/fordeling: Der er betydelig inter- og intraindividuelle variationer med hensyn til absorption af levodopa, carbidopa og entacapon.
English: Dopamine dysregulation syndrome is mentioned in the product information of other dopaminergic medication used in Parkinson's disease such as levodopa/carbidopa, apomorphine, levodopa/benserazide, rotigotine and ropinirole.
Danish: Dopaminergt dysreguleringssyndrom er nævnt i produktinformationen for andre dopaminerge lægemidler, der anvendes til Parkinsons sygdom, såsom levodopa/carbidopa, apomorphin, levodopa/benserazid, rotigotin og ropinirol.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
English: Other active substances: Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa.
Danish: Andre lægemidler: Dopaminreceptor-antagonister (f.eks. nogle antipsykotika og antiemetika), phenytoin og papaverin kan reducere levodopas terapeutiske virkning.
English: Caution should be exercised when the following active substances are administered concomitantly with levodopa therapy.
Danish: Forsigtighed bør udvises ved samtidig brug af følgende aktive stoffer og levodopabehandling.
English: A syndrome resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, mental changes and increased serum creatine phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents.
Danish: Et syndrom, der ligner malignt neuroleptikasyndrom og omfatter muskelstivhed, forhøjet kropstemperatur, mentale forandringer og øget serum kreatinfosfokinase, er rapporteret ved pludselig seponering af antiparkinsonmidler.
English: Levodopa is excreted in human breast milk.
Danish: Levodopa udskilles i human mælk.
English: Carbidopa and benserazide are peripheral DDC inhibitors which reduce the peripheral metabolism of levodopa to dopamine, and thus, more levodopa is available to the brain.
Danish: Carbidopa og benserazid er perifere DDC-hæmmere, der reducerer den perifere metabolisme af levodopa til dopamin ved at gøre mere levodopa tilgængelig for hjernen.
English: Levodopa/Carbidopa/Entacapone Orion should not be used during pregnancy unless the benefits for the mother outweigh the possible risks to the foetus.
Danish: Levodopa/Carbidopa/Entacapone Orion bør ikke anvendes under graviditet, med mindre fordelene for moderen opvejer mulige risici for fosteret.
English: Studies in animals have shown reproductive toxicity of the separate compounds (see section 5.3).
Danish: Dyrestudier har vist reproduktionstoksicitet for hvert af de enkelte stoffer (se pkt.
English: Fertility studies in animals have not been conducted with the combination of entacapone, levodopa and carbidopa.
Danish: Fertilitetsundersøgelser med dyr er ikke udført med kombinationen af entacapon, levodopa og carbidopa.
English: Total clearance for levodopa is in the range of 0.55-1.38 l/kg/h and for entacapone is in the range of 0.70 l/kg/h.
Danish: Total clearance for levodopa ligger i området 0,55-1,38 l/kg/time og for entacapon i området 0,70 l/kg/time.
English: In the pharmacokinetic studies with Levodopa/Carbidopa/Entacapone Orion the bioavailability of levodopa is higher in women than in men, primarily due to the difference in body weight, while there is no gender difference with carbidopa and entacapone.
Danish: I farmakokinetiske studier med Levodopa/Carbidopa/Entacapone Orion var biotilgængeligheden af levodopa højere for kvinder end for mænd, hovedsageligt pga. forskellen i kropsvægt, mens der ikke sås kønsforskelle med carbidopa og entacapon.
English: If any of this happens, contact your doctor immediately - feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour - find yourself suddenly falling asleep, or if you feel very drowsy.
Danish: Hvis det er tilfældet, skal du kontakte din læge øjeblikkeligt - føler dig deprimeret, har selvmordstanker eller oplever andre unormale forandringer i din adfærd - pludselig falder i søvn, eller hvis du føler dig meget søvnig.
English: The starting dose of Levodopa/Carbidopa/Entacapone Orion should provide either the same amount of levodopa or slightly (5-10%) more.
Danish: Startdosis af Levodopa/Carbidopa/Entacapone Orion bør indeholde enten den samme mængde af levodopa eller en anelse (5-10%) mere.
English: There are no adequate data from the use of the combination of levodopa/carbidopa/entacapone in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data fra brug af kombinationen levodopa/carbidopa/entacapon hos gravide kvinder.
English: Dopamine dysregulation syndrome is a well-recognised risk for dopaminergic medication used in Parkinson's disease.
Danish: Dopaminergt dysreguleringssyndrom er en velkendt risiko ved dopaminerge lægemidler, der anvendes til Parkinsons sygdom.
English: - Levodopa/carbidopa may cause false positive result when a dipstick is used to test for urinary ketone and this reaction is not altered by boiling the urine sample.
Danish: - Levodopa/carbidopa kan medføre falsk positive resultater, når der anvendes sticks til urinprøver for ketonstoffer, og denne reaktion ændres ikke ved at koge urinprøven.
English: Hepatic impairment: The metabolism of entacapone is slowed in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) leading to an increased plasma concentration of entacapone both in the absorption and elimination phases (see sections 4.2 and 4.3).
Danish: Nedsat leverfunktion: Metaboliseringen af entacapon er reduceret hos patienter med mild til moderat nedsat leverfunktion (”Child-Pugh” klasse A og B), hvilket medfører øget plasmakoncentration af entacapon både i absorptions- og eliminationsfasen (se pkt.
English: Biotransformation and elimination: Levodopa is extensively metabolised to various metabolites: decarboxylation by dopa decarboxylase (DDC) and O-methylation by catechol-O-methyltransferase (COMT) being the most important pathways.
Danish: Biotransformation og elimination: Levodopa metaboliseres i høj grad til forskellige metabolitter: Decarboxylering via dopadecarboxylase (DDC) og O-methylering via catechol-O-methyltransferase (COMT) er de vigtigste metaboliseringsveje.
English: In repeated dose toxicity studies with entacapone, anaemia most likely due to iron chelating properties of entacapone was observed.
Danish: I toksicitetsstudier med gentagne doser med entacapon er anæmi observeret, hvilket sandsynligvis skyldes entacapons evne til chelatbinding med jern.
English: - All patients treated with Levodopa/Carbidopa/Entacapone Orion should be monitored carefully for the development of mental changes, depression with suicidal tendencies, and other serious antisocial behaviour.
Danish: - Alle patienter, der behandles med Levodopa/Carbidopa/Entacapone Orion, bør overvåges omhyggeligt med hensyn til udvikling af mentale forandringer, depression med suicidale tendenser og anden alvorligt ændret social adfærd.
English: On the basis of the scientific conclusions for carbidopa/entacapone/levodopa the CHMP is of the opinion that the benefit-risk balance of the medicinal products containing carbidopa/entacapone/levodopa is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for carbidopa/entacapon/levodopa er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder carbidopa/entacapon/levodopa, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: The most frequently reported adverse reactions with Levodopa/Carbidopa/Entacapone Orion are dyskinesias occurring in approximately 19% of patients; gastrointestinal symptoms including nausea and diarrhoea occurring in approximately 15% and 12% of patients, respectively; muscle, musculoskeletal and connective tissue pain occurring in approximately 12% of patients; and harmless reddish-brown discolouration of urine (chromaturia) occurring in approximately 10% of patients.
Danish: De hyppigst rapporterede bivirkninger i forbindelse med Levodopa/Carbidopa/Entacapone Orion er dyskinesier, som forekommer hos cirka 19% af patienterne; gastrointestinale symptomer, herunder kvalme og diarré forekommer hos henholdsvis cirka 15% og 12% af patienterne, smerter i muskler, knogler og bindevæv forekommer hos cirka 12% af patienterne, og harmløs rødbrun misfarvning af urinen (kromaturi) forekommer hos cirka 10% af patienterne.