FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, caution should be exercised when potent noradrenaline uptake inhibitors such as desipramine, maprotiline, or venlafaxine are administered to Parkinson's disease patients being treated with Tasmar and levodopa preparations.
Danish: Derfor bør der udvises forsigtighed, når potente noradrenalinuptakehæmmere som f.eks. desipramin, maprotilin eller venlafaxin administreres til parkinsonpatienter i behandling med Tasmar og levodopapræparater.
English: Hepatocellular injury
Danish: Hepato-cellulær skade
English: In about half the cases, transaminase levels returned spontaneously to baseline values whilst patients continued Tasmar treatment.
Danish: I ca. halvdelen af tilfældene faldt transaminaseværdierne spontant til udgangsværdierne, medens patienterne fortsat var i
English: Tasmar should be discontinued if substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment regardless of dose.
Danish: Tasmar skal seponeres, hvis der ikke ses væsentlig klinisk bedring senest 3 uger efter behandlingens påbegyndelse uanset dosis.
English: The prescriber should be observant of adverse reactions caused by putative increased plasma levels of these drugs when combined with Tasmar.
Danish: Lægen bør være opmærksom på bivirkninger forårsaget af formodede øgede plasmakoncentrationer af disse lægemidler, når de anvendes sammen med Tasmar.
English: MAO inhibitors: Tasmar should not be given in conjunction with non-selective monoamine oxidase (MAO) inhibitors (e.g. phenelzine and tranylcypromine).
Danish: MAO-hæmmere: Tasmar bør ikke gives samtidig med non-selektive monoaminooxidase (MAO) hæmmere (f.eks phenelzin og tranylcypromin).
English: Drugs that increase catecholamines: Since tolcapone interferes with the metabolism of catecholamines, interactions with other drugs affecting catecholamine levels are theoretically possible.
Danish: Lægemidler der øger catecholaminer: Eftersom tolcapon interfererer med catecholaminers metabolisme, er interaktioner med andre lægemidler med effekt på catecholaminers koncentrationer teoretisk mulige.
English: Patients receiving multiple medications with effects on different central nervous system (CNS) pathways (e.g. antidepressants, neuroleptics, anticholinergics) may be at greater risk of developing NMS.
Danish: Patienter som får flere lægemidler med virkninger på forskellige funktioner i centralnervesystemet (CNS) (f.eks. antidepressiva, neuroleptika og antikolinergika) kan have større risiko for at få malignt neuroleptikasyndrom.
English: In animal studies, tolcapone was excreted into maternal milk.
Danish: I dyreundersøgelser blev tolcapon udskilt i modermælk.
English: The active substance is tolcapone (100 mg in each film- coated tablet) The other ingredients are:
Danish: Aktivt stof: Tolcapon (100 mg i hver filmovertrukken tablet) Øvrige indholdsstoffer:
English: If you do not get better at the higher dose after a total of 3 weeks, your doctor should stop your treatment with Tasmar.
Danish: Hvis du ikke får det bedre på den højere dosis i løbet af højst 3 uger, bør din læge stoppe behandlingen med Tasmar.
English: Symptoms of overdose may include nausea, vomiting, dizziness and breathing difficulties.
Danish: Symptomer på overdosering kan omfatte kvalme, opkastning, svimmelhed og vejrtrækningsvanskeligheder.
English: Carcinogenesis, mutagenesis: 3 % and 5 % of rats in the mid- and high- dose groups, respectively, of the 24-month carcinogenicity study were shown to have renal epithelial tumours (adenomas or carcinomas).
Danish: Carcinogenese, mutagenese: I et 24-måneders carcinogenicitetsstudie havde hhv. 3 % og 5 % af rotter i middel- og højdosisgrupperne renale epitelcelletumorer (adenomer og carcinomer).
English: Furthermore a reduction of levodopa dose or termination of therapy may be considered (see section 4.7).
Danish: Reduktion af dosis eller seponering af behandlingen bør desuden overvejes (se afsnit 4.7).
English: Increase of alanine aminotransferase (ALT)
Danish: Øget alaninaminotransferase (ALAT)
English: If you forget to take Tasmar
Danish: Hvis du har glemt at tage Tasmar
English: Summary of potentially Tasmar-related adverse reactions, with crude incidence rates for the phase III placebo-controlled studies:
Danish: Oversigt over hyppigheden af potentielle bivirkninger ved Tasmar fra fase III placebokontrollerede undersøgelser:
English: Symptoms have usually onset during Tasmar treatment or shortly after Tasmar has been discontinued.
Danish: Symptomerne er normalt startet under behandlingen med Tasmar eller kort efter, at behandlingen er seponeret.
English: Experience with Tasmar obtained in parallel placebo-controlled randomised studies in patients with Parkinson's disease is shown in the following table, which lists adverse reactions with a potential relationship to Tasmar.
Danish: Erfaringer fra parallelle, placebo-kontrollerede, randomiserede studier af behandling med Tasmar hos patienter med Parkinsons sygdom er vist i den nedenstående tabel, som angiver bivirkninger med en potentiel forbindelse med Tasmar.
English: Furthermore a reduction of levodopa dose or termination of therapy may be considered.
Danish: Reduktion af dosis eller seponering af behandlingen bør desuden overvejes.
English: A study in patients with hepatic impairment has shown that moderate non-cirrhotic liver disease had no impact on the pharmacokinetics of tolcapone.
Danish: En undersøgelse på patienter med nedsat leverfunktion viste, at moderat non-cirrhotisk leverlidelse ingen indflydelse havde på tolcapons farmakokinetik.
English: To improve efficacy your doctor should only increase the dose to 3 times daily 2 tablets (200 mg three times a day) if the increase in how your Parkinson´s disease symptoms are controlled outweighs the expected increase in side effects.The side effects at the higher dose can often be severe and affect your liver.
Danish: For at forbedre effekten bør din læge kun øge dosis til 2 tabletter (200 mg) 3 gange dagligt, hvis bedringen i dine parkinsonsymptomer opvejer den forventede stigning i bivirkninger Bivirkningerne af den højere dosis kan tit være alvorlige og kan påvirke leveren.
English: When beginning Tasmar, all patients should be informed of the symptoms of excessive levodopa dose and what to do if it occurs.
Danish: Når behandlingen med Tasmar påbegyndes, skal alle patienter informeres om symptomerne på for høj levodopadosis og om, hvad de i så fald skal gøre.
English: If treatment is discontinued: Patients who show evidence of acute liver injury while on Tasmar and are withdrawn from the medicinal product may be at increased risk for liver injury if Tasmar is reintroduced.
Danish: Hvis behandlingen seponeres: Patienter, som viser tegn på akut leverskade, mens de får Tasmar, og som stopper med Tasmarbehandlingen, kan være udsat for øget risiko for leverskade, hvis behandlingen med Tasmar genoptages.
English: While receiving treatment:
Danish: Under behandlingen:
English: Because of the risk of rare but potentially fatal acute liver injury, Tasmar is only indicated for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors.
Danish: På grund af risikoen for sjælden men potentiel akut, fatal leverskade, er Tasmar kun indiceret til patienter med idiopatisk levodoparesponderende Parkinsons sygdom og motoriske fluktuationer, som ikke responderer eller som ikke tolererer andre COMT-hæmmere.
English: Therefore, if symptoms occur after discontinuing Tasmar, physicians should consider increasing the patient's levodopa dose (see section 4.2).
Danish: Hvis der kommer symptomer ved reduktion af dosis eller ved seponering af Tasmar, skal lægen derfor overveje at øge patienternes levodopadosis (se afsnit 4.2).
English: Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a firstline adjunct therapy to levodopa/benserazide or levodopa/carbidopa (see sections 4.4 and 4.8).
Danish: På grund af risikoen for potentiel akut, fatal leverskade, må Tasmar ikke anvendes som førstevalgs-adjuvans til behandling med levodopa/benserazid eller levodopa/carbidopa (se afsnit 4.4 og 4.8).
English: Neuroleptic Malignant Syndrome Symptom Complex
Danish: Malignt neuroleptikasyndrom symptom kompleks
English: Adjustments in levodopa are most likely to be required within 1-2 days of Tasmar discontinuation.
Danish: Justering af levodopa er for det meste nødvendigt 1-2 dage efter seponering af Tasmar.
English: Administered concomitantly with levodopa and an aromatic amino acid decarboxylase inhibitor (AADC-I), it leads to more stable plasma levels of levodopa by reducing metabolism of levodopa to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).
Danish: Når det administreres samtidig med levodopa og en aromatisk decarboxylasehæmmer (AADC-I) medfører det mere stabile plasmaniveauer af levodopa, idet metaboliseringen af levodopa til 3-methoxy-4hydroxy-l-phenylalanin (3-OMD) reduceres.
English: Pharmaco-therapeutic group: Anti-Parkinson drugs, other dopaminergic agents, ATC code: NO4BX01
Danish: Farmakoterapeutisk klassifikation: Antiparkinsonmidler, ATC-kode: N04BX01
English: To reduce the risk of NMS you should not use Tasmar if your doctor says you have severe involuntary movement (dyskinesia) or a previous illness that may have been NMS.
Danish: For at nedsætte risikoen for MNS må du ikke tage Tasmar, hvis du har svære ufrivillige bevægelser (dyskinesi) eller tidligere har haft en sygdom, som kan have været MNS.
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines (see section 4.7).
Danish: Patienter som har oplevet somnolens og/eller en episode, hvor de pludselig falder i søvn, skal undlade at føre motorkøretøj eller betjene maskiner (se afsnit 4.7).
English: If you have been already treated with Tasmar and developed acute liver injury during treatment, Tasmar should not be re-introduced again.
Danish: Hvis du tidligere har taget Tasmar og fået akut leverskade under behandlingen, må du ikke få Tasmar igen.
English: The effects of Tasmar have not been studied in infants.
Danish: Effekten af Tasmar her ikke undersøgt hos spædbørn.
English: Renal impairment: The pharmacokinetics of tolcapone have not been investigated in patients with renal impairment.
Danish: Nedsat nyrefunktion: Tolcapons farmakokinetik er ikke blevet undersøgt på patienter med nedsat nyrefunktion.
English: An increased incidence of uterine adenocarcinomas was seen in the high-dose group of the rat carcinogenicity study.
Danish: Der observeredes en øget forekomst af livmoderadenocarcinomer i højdosisgruppen i carcinogenicitetsundersøgelsen på rotte.
English: You should not breast-feed your infant during treatment with Tasmar.
Danish: Du må ikke amme dit spædbarn under behandling med Tasmar.
English: Sodium lauril sulfate
Danish: Natriumlaurilsulfat
English: In addition, rhabdomyolysis, secondary to NMS or severe dyskinesia, has been observed.
Danish: Desuden er der observeret rhabdomyolyse, som var sekundær til malignt neuroleptikasyndrom, eller svære dyskinesier.
English: Tasmar may cause rare but potentially fatal liver injury.
Danish: Tasmar kan i sjældne tilfælde forårsage leverskader, der kan være dødelige.
English: In an interaction study, tolcapone did not change the pharmacokinetics of tolbutamide.
Danish: I en interaktionsundersøgelse ændrede tolcapon ikke tolbutamids farmakokinetik.
English: When beginning and during treatment with Tasmar, your dose of Levodopa may need to be changed.
Danish: Når du begynder og under behandlingen med Tasmar kan det være nødvendigt at ændre din levodopadosis.
English: Since Tasmar should be used only in combination with levodopa/benserazide and levodopa/carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.
Danish: Eftersom Tasmar skal anvendes udelukkende i kombination med levodopa/benserazid og levodopa/carbidopa er produktinformationerne for disse levodopapræparater også gældende for deres samtidige anvendelse med Tasmar.
English: Uncommon: liver injury, in rare cases with fatal outcome
Danish: Ikke almindelige bivirkninger: - leverskade, i nogle tilfælde med fatale følger
English: Hepatocellular injury, in rare cases with fatal outcome* (see section 4.4)
Danish: Hepato-cellulær skade, i sjældne tilfælde med fatalt udfald* (se pkt.
English: 1 film-coated tablet Tasmar
Danish: 1 filmovertrukken tablet Tasmar
English: If you feel unwell, you should contact your doctor because you may need to take less levodopa.
Danish: Hvis du føler dig utilpas, skal du kontakte din læge, da du måske skal tage mindre levodopa.
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Danish: Patienter som har oplevet somnolens og/eller en episode, hvor de pludselig falder i søvn, skal undlade at føre motorkøretøj eller betjene maskiner.
English: Hepatic impairment: Because of the risk of liver injury observed during post-marketing use, Tasmar is contraindicated in patients with liver disease or increased liver enzymes.
Danish: Nedsat leverfunktion: På grund af risikoen for leverskade, som er observeret under anvendelse efter markedsføringen, er Tasmar kontraindiceret til patienter med leversygdom eller forhøjede leverenzymer.
English: Other Medicines and Tasmar
Danish: Brug af anden medicin sammen med Tasmar
English: The NMS consists of some or all of the following: severe muscle stiffness, jerking movements of muscles, arms or legs, and soreness of muscles.
Danish: MNS omfatter nogle af eller alle følgende symptomer: - svær muskelstivhed, rykvise bevægelser i muskler, arme eller ben og ømhed i musklerne.
English: The most commonly observed adverse reactions associated with the use of Tasmar, occurring more frequently than in placebo-treated patients are listed in the table below.
Danish: De mest almindeligt observerede bivirkninger relateret til anvendelsen af Tasmar, som forekommer hyppigere end hos placebobehandlede patienter fremgår af nedenstående tabel.
English: if you are hypersensitive (allergic) to the active substance tolcapone or to any of the other ingredients of Tasmar.
Danish: - hvis du er allergisk overfor det aktive stof tolcapon eller et af de øvrige indholdsstoffer i Tasmar (angivet i punkt 6).
English: Isolated cases of patients with symptoms suggestive of Neuroleptic Malignant Syndrome Symptom Complex (see section 4.4) have been reported following reduction or discontinuation of Tasmar and following introduction of Tasmar when this was accompanied by a significant reduction in other concomitant dopaminergic medications.
Danish: Der er i isolerede tilfælde rapporteret om patienter med symptomer på malignt neuroleptikasyndrom (se afsnit 4.4) efter reduktion eller seponering af Tasmar og efter påbegyndelse af Tasmar efter signifikant reduktion af andre samtidige dopaminerge lægemidler.
English: If substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment (regardless of dose) Tasmar should be discontinued.
Danish: Hvis betydelig klinisk bedring ikke er set 3 uger efter behandlingens påbegyndelse (uanset dosis), skal Tasmar seponeres.
English: In Parkinson`s patients, NMS tends to occur when discontinuing or stopping dopaminergic-enhancing medications.
Danish: Hos parkinsonpatienter har malignt neuroleptikasyndrom tendens til at indtræffe, når behandling med dopaminerg-forstærkende medicin afbrydes eller stoppes.
English: Tasmar treatment should also be discontinued if ALT (alanine amino transferase) and/or AST (aspartate amino transferase) exceed the upper limit of normal or symptoms or signs suggest the onset of hepatic failure (see section 4.4).
Danish: Tasmar behandlingen bør seponeres, hvis ALAT (alaninaminotransferase) og/eller ASAT (aspartataminotransferase) overskrider den øvre referencegrænse, eller hvis der kommer symptomer eller tegn på start af leversvigt (Se afsnit 4.4).
English: dreaming excessive.
Danish: Unormale drømme
English: Before starting treatment: To reduce the risk of NMS, Tasmar should not be prescribed for patients with severe dyskinesia or a previous history of NMS including rhabdomyolysis or hyperthermia (see section 4.3).
Danish: Før behandlingen påbegyndes: For at nedsætte risikoen for malignt neuroleptikasyndrom bør Tasmar ikke ordineres til patienter med svære dyskinesier eller tidligere malignt neuroleptikasyndrom, inklusive rhabdomyolyse og hypertermi (se afsnit 4.3).
English: Patients with hepatic impairment (see section 4.3) Tasmar is contraindicated for patients with liver disease or increased liver enzymes.
Danish: Patienter med nedsat leverfunktion (se afsnit 4.3) Tasmar er kontraindiceret til patienter med leversygdom eller forhøjede leverenzymer.
English: Very rare (<1/10,000), not known (cannot be estimated from the available data)
Danish: Meget almindelig (>1/10) almindelig (>1/100, <1/10) ikke almindelig (>1/1000, <1/100) sjælden (>1/10.000, <1/1000) meget sjælden (<1/10.000) ikke kendt (kan ikke estimeres ud fra tilgængelige data)
English: Warfarin: Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these drugs are co-administered.
Danish: Warfarin: Idet klinisk information er begrænset vedrørende kombinationen af warfarin og tolcapon, bør koagulationsparametre kontrolleres, når disse lægemidler administreres samtidig.
English: The only adverse reaction commonly leading to discontinuation of Tasmar in clinical trials was diarrhoea (see section 4.4).
Danish: Den eneste bivirkning, der ofte medførte seponering af Tasmar i kliniske undersøgelser, var diarré (se afsnit 4.4).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for blister packs [ 30 and 60 film-coated tablets]
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske for blisterpakninger,[ 30 og 60 filmovertrukne tabletter]
English: The peak plasma concentrations of tolcapone at this dose were on average 30 µg/ml (compared to 3 and 6 µg/ml with 100 mg tid and 200 mg tid of tolcapone respectively).
Danish: De maksimale plasmakoncentrationer af tolcapon ved denne dosis var i gennemsnit 30 μg/ml (sammenlignet med 3 μg/ml og 6 μg/ml ved hhv. 100 mg og 200 mg tolcapon tre gange daglig).
English: Neuroleptic Malignant Syndrome (NMS):
Danish: Malignt neuroleptikasyndrom (MNS):
English: Tasmar used with your other Parkinson medicines can cause excessive drowsiness (somnolence ) and sudden sleep onset episodes (you may suddenly fall asleep).
Danish: Tasmar kan, sammen med din anden medicin mod Parkinsons sygdom, medføre ekstrem træthed (somnolens) og episoder, hvor du pludseligt falder i søvn.
English: The data of more than 400 patients have confirmed that over a wide range of creatinine clearance values (30-130 mL/min) the pharmacokinetics of tolcapone are unaffected by renal function.
Danish: Data fra flere end 400 patienter har bekræftet, at tolcapons farmakokinetik er upåvirket af nyrefunktionen over et bredt område af kreatininclearance (30 - 130 ml/min).
English: You should only receive Tasmar if your Parkinson's disease is not adequately controlled by the use of other therapies.
Danish: Du skal kun behandles med Tasmar, hvis din parkinsonisme ikke kan kontrolleres tilstrækkeligt med anden behandling.
English: What Tasmar contains
Danish: Tasmar indeholder:
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 Tasmar in association with levodopa.
Danish: Patienter og plejepersonale skal gøres opmærksomme på, at adfærdsmæssige symptomer på manglende impulskontrol, herunder ludomani, øget libido, hyperseksualitet, overdrevent forbrug eller overdrevne indkøb samt overspisning eller tvangs-spisning kan forekomme hos patienter i behandling med dopaminagonister og/eller andre dopaminerge lægemidler som Tasmar i kombination med levodopa.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige lidelser med lactoseintolerans, Lapp lactase mangel eller glucosegalactose-malabsorption bør ikke indtage dette lægemiddel.
English: Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these drugs are co-administered.
Danish: Eftersom der er begrænsede kliniske oplysninger om kombinationen af warfarin og tolcapon, bør koagulationsparametrene kontrolleres, når disse lægemidler anvendes sammen.
English: Your doctor should always begin your treatment with the standard dose of 3 times daily 1 tablet (100 mg (1 tablet)).
Danish: Lægen vil normalt starte med standarddosis på 1 tablet (100 mg) 3 gange dagligt.
English: Diarrhoea led to withdrawal of 5% and 6% of patients receiving Tasmar 100 mg tid and 200 mg tid respectively, compared to 1 % of patients receiving placebo.
Danish: Diarré medførte seponering hos hhv. 5 % og 6 % af patienterne, der fik 100 mg og 200 mg Tasmar, sammenlignet med 1 % af patienterne på placebo.
English: NMS is characterised by motor symptoms (rigidity, myoclonus and tremor), mental status changes (agitation, confusion, stupor and coma), elevated temperature, autonomic dysfunction (labile blood pressure, tachycardia) and elevated serum creatine phosphokinase (CPK) which may be a consequence of myolysis.
Danish: Malignt neuroleptikasyndrom er karakteriseret ved motoriske symptomer (rigiditet, myoclonus og tremor), mentale ændringer (uro, konfusion, stupor og koma), temperaturstigning, autonom dysfunktion (ustabilt blodtryk, takykardi) og forhøjet serumkreatininphosphokinase (CPK), som kan skyldes myolyse.
English: You must tell your doctor if you are pregnant or intend to become pregnant.
Danish: - har besvaret alle de spørgsmål, som du måtte have - Hvis du er gravid eller planlægger at blive gravid.
English: Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige lidelser med lactoseintolerans, Lapp lactase mangel eller glucosegalactose-malabsorption bør ikke indtage dette lægemiddel
English: The t1/2 of tolcapone is approximately 2 hours.
Danish: Tolcapons t½ er ca. 2 timer.
English: However, when Tasmar therapy is being discontinued for reasons other than too much levodopa, levodopa dose may have to be increased to levels equal to or greater than before initiation of Tasmar therapy, especially if the patient had large decreases in levodopa when starting Tasmar.
Danish: Hvis behandlingen med Tasmar imidlertid seponeres af andre årsager end for meget levodopa, skal levodopadosis måske øges til samme niveau, som før behandlingen med Tasmar påbegyndtes eller højere, specielt hos patienter med store levodopareduktioner ved påbegyndelsen af behandlingen med Tasmar.
English: Tasmar can be combined with all pharmaceutical formulations of levodopa/benserazide and levodopa/carbidopa (see also section 4.5).
Danish: Tasmar kan kombineres med alle lægemiddelformer af levodopa/benserazid og levodopa/carbidopa (se også afsnit 4.5)
English: Always follow the instructions of your doctor about the duration of the treatment with Tasmar.
Danish: Følg altid lægens råd om, hvor længe du skal tage Tasmar.
English: Inform your doctor also: - if you have any illnesses other than Parkinson's disease, - if you are allergic to other medicines, food and dyes, - if soon after beginning and during treatment with Tasmar you have symptoms which may be caused by levodopa such as involuntary movement (dyskinesia) and nausea.
Danish: Fortæl også din læge: - hvis du har andre sygdomme end Parkinsons sygdom - hvis du er allergisk overfor anden medicin, mad eller farvestoffer - hvis du kort efter behandlingsstart med Tasmar får symptomer, som kan skyldes levodopa som f.eks. ufrivillige bevægelser (dyskinesi) eller kvalme.