FrancophonIA/ELRC3.0 huggingface dataset:
English: With 200 mg tolcapone, maximum inhibition of erythrocyte COMT activity is, on average, greater than 80 %.
Danish: Med 200 mg tolcapon er den maksismale hæmning af erytrocyt-COMT-aktiviteten i gennemsnit større end 80 %.
English: Therefore, Tasmar should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Derfor bør Tasmar kun anvendes under graviditet, hvis de potentielle fordele vejer tungere end den potentielle risiko for fostret.
English: The safety of tolcapone in infants is unknown; therefore, women should not breast-feed during treatment with Tasmar.
Danish: Sikkerheden hos spædbørn kendes ikke; derfor bør kvinder ikke amme under behandling med Tasmar.
English: In general, the average peak levodopa plasma concentration (Cmax) and the time of its occurrence (tmax) were unaffected.
Danish: Almindeligvis påvirkes den gennemsnitlige maksimale levodopakoncentration (Cmax) og tidspunktet derfor (tmax) ikke.
English: The following preventive measures have to be considered.
Danish: Følgende forebyggende foranstaltninger skal overvejes:
English: Do not use after the expiry date on the pack.
Danish: Brug ikke Tasmar efter den udløbsdato, der står på pakningen.
English: Possible side effects Like all medicines, this medicine can have side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Your doctor will discuss the risks and benefits of taking Tasmar during pregnancy.
Danish: Din læge vil snakke med dig om risiko og fordele ved behandling med Tamar under graviditet.
English: The following doses of Tasmar should be taken 6 and 12 hours later.
Danish: Følgende doser Tasmar skal tages efter 6 og 12 timer:
English: Isolated cases of either accidental or intentional overdose with tolcapone tablets have been reported.
Danish: I enkeltstående tilfælde er der rapporteret om utilsigtet eller tilsigtet overdosering med tolcapontabletter.
English: Tasmar tablets are film-coated and should be swallowed whole because tolcapone has a bitter taste.
Danish: Tasmar tabletter er filmovertrukne og skal sluges hele, idet tolcapon har en bitter smag.
English: You should not start taking Tasmar until your doctor - has described the risks of treatment with Tasmar, - has explained the measures necessary to minimise those risks, - has answered any questions you may have.
Danish: Du må ikke begynde at tage Tasmar før din læge - har oplyst dig om risikoen ved behandling med Tasmar - har oplyst dig om de forholdsregler, som er nødvendige for at mindske denne risiko - har besvaret alle de spørgsmål, som du måtte have
English: Nausea, vomiting and dizziness were observed, particularly in combination with levodopa.
Danish: Der observeredes kvalme, opkastning og svimmelhed, især i kombination med levodopa.
English: 35-959 Rzeszów Poland
Danish: 35-959 Rzeszów Polen
English: Tolcapone markedly reduces the formation of 3-OMD.
Danish: Tolcapon reducerer dannelsen af 3-OMD betydeligt.
English: Urine discolouration: Tolcapone and its metabolites are yellow and can cause a harmless intensification in the colour of the patient's urine.
Danish: Misfarvning af urinen: Tolcapon og dets metabolitter er gule og kan medføre en uskadelig intensivering af farven af patientens urin.
English: Sleep disorder Dreaming excessive Somnolence Confusion Hallucination
Danish: Søvnforstyrrelser unormale drømme Søvnighed Konfusion Hallucinationer
English: The main metabolic pathway of tolcapone is conjugation to its inactive glucuronide.
Danish: Hovedomdannelsesvejen af tolcapon er konjugering til dets inaktive glucuronid.
English: Tasmar 100 mg (only applicable for the outer carton)
Danish: Tasmar 100 mg (er kun relevant for den ydre æske)
English: In addition, the compound is methylated by COMT to 3-O-methyl-tolcapone and metabolised by cytochromes P450 3A4 and P450 2A6 to a primary alcohol (hydroxylation of the methyl group), which is subsequently oxidised to the carboxylic acid.
Danish: Derudover methyleres stoffet af COMT til 3-Omethyltolcapon og metaboliseres af cytochrom P450 3A4 og P450 2A6 til en primær alkohol (hydroxylering af methylgruppen), som derefter oxideres til carboxylsyren.
English: Tasmar with food and drink and alcohol Tasmar can be taken with or without food.
Danish: Brug af Tasmar sammen med mad, drikke og alkohol Tasmar kan tages med og uden mad.
English: Talk to your doctor or pharmacist before taking Tasmar.
Danish: Tal med lægen eller apoteket inden du tager Tasmar.
English: Primary Outcome
Danish: Primært resultat
English: Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa.
Danish: Patienterne skal informeres om dette, og de bør rådes til at være forsigtige, hvis de fører motorkøretøj eller betjener maskiner, mens de er i behandling med levodopa.
English: The first tablet Tasmar is to be taken in the morning together with your other parkinsonian medicine ‘levodopa'.
Danish: Den første tablet tages om morgenen sammen med din anden parkinson-medicin ”levodopa”.
English: Do not reduce or stop taking your medicine unless your doctor tells you.
Danish: Du må ikke nedsætte dosis eller stoppe med at tage din medicin, medmindre du har fået besked på det af lægen.
English: Tasmar is used when all other alternative medicines cannot stabilise your Parkinson's disease.
Danish: Tasmar anvendes, når alle andre lægemidler ikke kan stabilisere din parkinsonisme.
English: However, a study in Parkinson's patients confirmed that after treatment discontinuation there was no significant change in levodopa pharmacokinetics or in patient response to levodopa compared to pretreatment levels.
Danish: En undersøgelse af parkinsonpatienter bekræftede imidlertid, at der efter seponering af behandlingen ikke forekom nogen signifikant ændring af levodopas farmakokinetik eller af patientens respons på levodopa sammenlignet med niveauerne før behandlingen.
English: Clinical Efficacy and Safety
Danish: Klinisk Virkning og Sikkerhed:
English: Biotransformation/Elimination: Tolcapone is almost completely metabolised prior to excretion, with only a very small amount (0.5 % of dose) found unchanged in urine.
Danish: Biotransformation/elimination: Tolcapon metaboliseres næsten fuldstændigt før udskillelse og kun en mindre del (0,5 % af dosis) genfindes uomdannet i urinen.
English: If you develop any symptoms as described above, that you think may be NMS, you should report them to your doctor immediately.
Danish: Hvis du får et hvilket som helst symptom beskrevet ovenfor, som, du tror, kan være MNS, skal du øjeblikkeligt kontakte en læge.
English: The first dose of the day of Tasmar should be taken together the first dose of the day of a levodopa preparation, and the subsequent doses should be given approximately 6 and 12 hours later.
Danish: Den første dagsdosis af Tasmar bør indtages sammen med den første dagsdosis af et levodopapræparat, og efterfølgende doser bør indtages ca. 6 og 12 timer senere.
English: Liver injury has occurred most often after 1 month and before 6 months.
Danish: Leverskader har oftest optrådt efter 1 måneds behandling og inden for 6 måneder.
English: For oral use The tablets should be swallowed whole.
Danish: Til oralt brug Tabletterne skal synkes hele.
English: The effect of tolcapone on the pharmacokinetics of other drugs metabolised by COMT such as -methyldopa, dobutamine, apomorphine, adrenaline and isoprenaline have not been evaluated.
Danish: Effekten af tolcapon på farmakokinetikken af andre lægemidler, som metaboliseres af COMT, som f.eks. α-methyldopa, dobutamin, apomorfin, adrenalin og isoprenalin, er ikke blevet undersøgt.
English: Przemysłowa 2 35-959 Rzeszów Poland
Danish: Przemysłowa 2 35-959 Rzeszów Polen
English: The highest dose of tolcapone administered to humans was 800 mg three times daily, with and without levodopa coadministration, in a one week study in healthy elderly volunteers.
Danish: Den højeste dosis tolcapon, der er blevet indgivet til mennesker er 800 mg tre gange daglig, med eller uden samtidig indgift af levodopa, i en 7 døgns undersøgelse på ældre, raske frivillige.
English: Tolcapone is an orally active, selective and reversible catechol-O-methyltransferase (COMT) inhibitor.
Danish: Tolcapon er en oral aktiv, selektiv og reversibel catechol-O-methyltransferase (COMT-hæmmer).
English: This could be explained by the fact that only a negligible amount of unchanged tolcapone is excreted in the urine, and the main metabolite, tolcapone-glucuronide, is excreted both in urine and in bile (faeces).
Danish: Dette kan forklares ved, at kun en ubetydelig del af uomdannet tolcapon udskilles i urinen og hovedmetabolitten, tolcapon-glucuronid, udskilles både i urin og i galde (fæces).
English: A double-blind trial compared Tasmar with entacapone in Parkinson's disease patients who had at least three hours of OFF time per day while receiving optimised levodopa therapy.
Danish: Et dobbelt-blindet studie sammenlignede Tasmar med entakapon hos patienter med Parkinsons sygdom, som havde mindst 3 timers OFF-time pr. dag, mens de fik optimeret behandling med levodopa.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studer af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: There is no evidence from clinical studies that Tasmar adversely influences a patient's ability to drive and use machines.
Danish: Der er intet fra kliniske undersøgelser som tyder på, at Tasmar har en negativ indflydelse på en patients evne til at føre bil eller betjene maskiner.
English: Swallow Tasmar with 1 glass of water.
Danish: Tag Tasmar med 1 glas vand.
English: Only in exceptional circumstances, when the anticipated incremental clinical benefit justifies the increased risk of hepatic reactions, should the dose be increased to 200 mg three times daily (see sections 4.4 and 4.8).
Danish: Kun i særlige tilfælde når den forventede øgede kliniske bedring retfærdiggør den øgede risiko for hepatiske reaktioner, kan dosis øges til 200 mg tre gange daglig (Se afsnit 4.4 og 4.8).
English: When Tasmar was given together with levodopa/carbidopa and desipramine, there was no significant change in blood pressure, pulse rate and plasma concentrations of desipramine.
Danish: Når Tasmar blev anvendt sammen med levodopa/carbidopa og desipramin, var der ingen signifikant ændring af blodtryk, puls og plasmakoncentrationer af desipramin.
English: The treatment with Tasmar may sometimes lead to disturbances in the way the liver works.
Danish: Behandling med Tasmar kan nogle gange medføre forstyrrelser i leverfunktionen.
English: Selective MAO-B inhibitors should not be used at higher than recommended doses (e.g. selegiline 10 mg/day) when coadministered with Tasmar.
Danish: Selektive MAO-B-hæmmere bør ikke anvendes i højere doser, end de anbefalede (f.eks. selegilin 10 mg/dag), når de administreres sammen med Tasmar.
English: Increase of alanine aminotransferase
Danish: Øget alaninaminotransferase
English: This is due to a decrease in clearance in L-dopa resulting in a prolongation of the terminal elimination half-life (t1/2) of levodopa.
Danish: Dette skyldes en nedsættelse af clearance af L-dopa, som medfører en forlængelse af levodopas terminale eliminationshalveringstid (t½).
English: There were no similar renal findings in the mouse or dogs carcinogenicity studies.
Danish: Der var ingen tilsvarende renale fund i carcinogenicitetsundersøgelserne på mus og hunde.
English: High levels of plasma 3-OMD have been associated with poor response to levodopa in Parkinson's disease patients.
Danish: Høje 3-OMD-plasmakoncentrationer er sat i forbindelse med dårligt respons på levodopa hos parkinsonpatienter.
English: Before starting treatment: If liver function tests are abnormal or there are signs of impaired liver function, Tasmar should not be prescribed.
Danish: Før behandlingen påbegyndes: Hvis leverfunktionstestene er abnorme, eller hvis der er tegn på nedsat leverfunktion, må der ikke ordineres Tasmar.
English: Effect of tolcapone on the metabolism of other drugs: Due to its affinity for cytochrome CYP2C9 in vitro, tolcapone may interfere with drugs whose clearance is dependent on this metabolic pathway, such as tolbutamide and warfarin.
Danish: Effekt af tolcapon på metabolismen af andre lægemidler: På grund af dets affinitet til cytochrom CYP2C9 in vitro, kan tolcapon muligvis interferere med lægemidler, hvis clearance er afhængig af denne metaboliske omdannelsesvej, som f.eks. tolbutamid og warfarin.
English: Studies in healthy volunteers have shown that tolcapone reversibly inhibits human erythrocyte COMT activity after oral administration.
Danish: Undersøgelse med raske frivillige har vist, at tolcapon reversibelt hæmmer erytrocyt-COMT-aktivitet efter oral administration.
English: Date of first authorisation: 27 August 1997 Renewal of the authorisation: 31 August 2004 Date of latest renewal: 21 July 2014
Danish: Dato for første markedsføringstilladelse: 27. august 1997 Dato for fornyelse af tilladelsen: 31. august 2004
English: Do not take a double dose to make up for forgotten individual doses.
Danish: Tag aldrig dobbelt dosis som erstatning for den glemte dosis.
English: The inhibition is closely related to plasma tolcapone concentration.
Danish: Hæmningen er tæt knyttet til plasmakoncentrationen af tolcapon.
English: Soon after beginning and during your treatment with Tasmar, you may have symptoms caused by levodopa such as involuntary movement and nausea.
Danish: Kort efter start med Tasmar og under behandlingen kan du få symptomer forårsaget af levodopa som f.eks. ufrivillige bevægelser og kvalme.
English: Tasmar blocks this enzyme and thus slows the breakdown of levodopa.
Danish: Tasmar blokerer dette enzym og nedsætter derfor nedbrydningen af levodopa.
English: *: Adverse reactions for which no frequency could be derived from clinical studies (i.e. where a specific adverse reaction was not observed in clinical trials but was reported post-marketing only) are indicated by an asterisk (*), and the frequency category has been calculated according to EU Guideline.
Danish: *: Bivirkninger, som der ikke kunne beregnes frekvens for ud fra kliniske studier (f.eks. bivirkninger, som ikke er set i kliniske studier, men som er rapporteret post-marketing) er markeret med asterisk(*), og frekvensen er beregnet i følge EU retningsliner.
English: The reduction to a putative amine, as well as the subsequent N-acetylation, occurs to a minor extent.
Danish: I mindre udstrækning forekommer reduktion, formentlig til en amin, og efterfølgende N-acetylering.
English: However, the relationship of renal function and tolcapone pharmacokinetics has been investigated using population pharmacokinetics during clinical trials.
Danish: Imidlertid er forholdet mellem nyrefunktion og tolcapons farmakokinetik blevet undersøgt ved anvendelse af populationsfarmakokinetik i kliniske undersøgelser.
English: Toxicity to reproduction: Tolcapone, when administered alone, was shown to be neither teratogenic nor to have any relevant effects on fertility.
Danish: Reproduktionstoksicitet: Det blev påvist, at tolcapon, indgivet alene, hverken er teratogent eller har nogen relevant indflydelse på fertilitet.
English: No effects were seen on the pharmacokinetics of the COMT substrate carbidopa.
Danish: Der observeredes ingen effekt på farmakokinetikken af COMT-substratet carbidopa.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om Tasmar findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In rats and rabbits, embryo-foetal toxicity was observed after tolcapone administration (see section 5.3).
Danish: Der er observeret embryoføtal toksicitet hos rotter og kaniner efter indgift af tolcapon (se afsnit 5.3).
English: Tell your doctor if you or your family/ carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: Fortæl det til lægen, hvis du, din familie eller dine plejere bemærker, at du udvikler trang eller hunger efter at udføre handlinger, som er usædvanlige for dig, eller hvis du ikke kan modstå impulser, drifter eller fristelser til at udføre bestemte aktiviteter, som kan skade dig selv eller andre.
English: 1 Primary and Secondary Outcome of double-blind Trial Entacapone
Danish: Tabel 1 Primært og sekundært resultat af dobbelt-blindet studie Entakapon
English: Contact your doctor, pharmacist or hospital immediately as you may need urgent medical attention.
Danish: Kontakt omgående din læge, et apotek eller et sygehus da du måske har brug for omgående hjælp.
English: However patients should be advised that their ability to drive and operate machines may be compromised due to their Parkinson's disease symptoms.
Danish: Imidlertid bør patienterne gøres opmærksom på, at deres evne til at føre bil eller betjene maskiner kan være forringet på grund af symptomerne af deres Parkinsons sygdom.
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: Dette kaldes manglende impulskontrol og kan omfatte afhængighed af spil, overspisning eller overforbrug, en unormal høj seksualdrift eller en øget interesse for seksuelle tanker eller følelser.
English: No studies on the effects of Tasmar on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser om Tasmars indflydelse på evnen til at føre bil eller betjene maskiner.
English: Dyskinesia, nausea and other levodopa-associated adverse reactions: Patients may experience an increase in levodopa-associated adverse reactions.
Danish: Dyskinesier, kvalme og andre levodopa-relaterede bivirkninger: Patienter kan komme ud for en øgning af levodopa-relaterede bivirkninger.
English: If Tasmar is to be prescribed, the patient should be informed about the signs and symptoms which may indicate liver injury, and to contact the physician immediately.
Danish: Hvis der ordineres Tasmar, skal patienten informeres om tegn og symptomerne på leverskade, og om at kontakte lægen øjeblikkelig.
English: Diarrhoea associated with Tasmar usually began 2 to 4 months after initiation of therapy.
Danish: Diarré, som var relateret til Tasmar, forekom almindeligvis 2 til 4 måneder efter påbegyndelse af behandlingen.
English: Levodopa adjustments during Tasmar treatment:
Danish: Justering af levodopa under Tasmar-behandlingen:
English: If another person accidentally takes your medicine, contact a doctor or hospital immediately as he or she may need urgent medical attention.
Danish: Hvis en anden person ved et uheld kommer til at tage din medicin, skal du omgående kontakte en læge, et apotek eller et sygehus, da vedkommende måske har brug for omgående hjælp.
English: Catechols and other drugs metabolised by catechol-O-methyltransferase (COMT): Tolcapone may influence the pharmacokinetics of drugs metabolised by COMT.
Danish: Catecholer eller andre lægemidler, som metaboliseres af catechol-O-methyltransferase (COMT): Tolcapon kan influere på farmakokinetikken af lægemidler, der metaboliseres af COMT.
English: During dosing with Tasmar 200 mg three times daily, erythrocyte COMT inhibition at trough is 30 % to 45 %, with no development of tolerance.
Danish: Ved anvendelse af 200 mg tolcapon tre gange daglig er erytrocyt-COMT-hæmningen ved laveste niveau 30 % til 45 %, uden udvikling af tolerance.
English: Benserazide interaction: Due to the interaction between high dose benserazide and tolcapone (resulting in increased levels of benserazide), the prescriber should, until more experience has been gained, be observant of dose-related adverse reactions (see section 4.5).
Danish: Interaktion med benserazid: På grund af interaktionen mellem en høj benseraziddosis og tolcapondosis (som medfører øgede koncentrationer af benserazid), bør lægen, indtil der er opnået flere erfaringer, være opmærksom på dosis-relaterede bivirkninger (se afsnit 4.5).
English: Do not stop Tasmar or any other Parkinson's medications without telling your doctor as this may increase the risk of NMS.
Danish: Du må ikke holde op med at tage Tasmar eller anden medicin mod Parkinsons sygdom uden aftale med din læge, da det øger risikoen for MNS.
English: If you go to hospital or if you are prescribed a new medicine, you must tell your doctor that you are taking Tasmar.
Danish: Hvis du bliver indlagt på sygehus, eller hvis du får ordineret en ny medicin, skal du fortælle lægen, at du tager Tasmar.
English: Liver injury has most often occurred between 1 month and 6 months after starting treatment with Tasmar.
Danish: Leverskader er for det meste indtruffet fra 1 til 6 måneder efter, at behandlingen med Tasmar er påbegyndt.
English: As Tasmar decreases the breakdown of levodopa in the body, side effects due to increased levodopa concentrations may occur when beginning Tasmar treatment.
Danish: Da Tasmar nedsætter nedbrydningen af levodopa i kroppen, kan der komme bivirkninger på grund af øgede levodopakoncentrationer, når behandlingen med Tasmar påbegyndes.
English: The combination of MAO-A and MAO-B inhibitors is equivalent to non-selective MAO-inhibition, therefore they should not both be given concomitantly with Tasmar and levodopa preparations (see also section 4.5).
Danish: Kombinationen af MAO-A- og MAO-B-hæmmere er ækvivalent til non-selektiv MAO-hæmning, og derfor bør de ikke gives samtidig med Tasmar og levodopa præparater (se også afsnit 4.5).
English: If you stop taking Tasmar
Danish: Hvis du holder op med at tage Tasmar
English: Double blind placebo controlled clinical studies have shown a significant reduction of approximately 20 % to 30 % in OFF time and a similar increase in ON time, accompanied by reduced severity of symptoms in fluctuating patients receiving Tasmar.
Danish: I dobbelt-blindede, placebokontrollerede kliniske undersøgelser er der vist en signifikant reduktion på ca. 20 % til 30 % i OFF-tid og en tilsvarende forlængelse af ON-tid efterfulgt af nedsat symptomsværhedsgrad hos fluktuerende patienter, der fik Tasmar.
English: Levodopa dose should not be decreased when Tasmar therapy is being discontinued due to side effects related to too much levodopa.
Danish: Levodopadosis skal ikke nedsættes, hvis behandlingen med Tasmar seponeres på grund af bivirkninger, som skyldes for meget levodopa.
English: See leaflet for further information
Danish: Læs indlægssedlen for mere information
English: In addition, your doctor will stop Tasmar treatment if after 3 weeks you do not improve enough to justify the risks of continuing treatment.
Danish: Din læge vil stoppe behandlingen med Tasmar efter 3 uger, hvis din sygdom ikke bedres så meget, at det opvejer risikoen ved fortsat behandling.
English: When Tasmar is administered together with levodopa, it increases the relative bioavailability (AUC) of levodopa approximately twofold.
Danish: Når Tasmar administreres sammen med levodopa, øger det den relative biotilgængelighed (AUC) af levodopa til omkring det dobbelte.
English: Neuroleptic Malignant Syndrome Symptom Complex (see section 4.4)
Danish: Malignt neuroleptikasyndrom symptom kompleks (se pkt 4.4)
English: Based on the physicochemical properties of the compound, hemodialysis is unlikely to be of benefit.
Danish: På grund af stoffets fysisk-kemiske egenskaber kan hæmodialyse ikke forventes at være af værdi.
English: Vomiting Constipation Xerostomia Abdominal pain Dyspepsia
Danish: Opkastning Obstipation Xerostomi Abdominalsmerter Dyspepsi