natgillin/translations-raw huggingface dataset:
CHMP anbefalede derfor, at der i produktoplysningerne medtages en advarsel om parkinsonisme forårsaget af trimetazidin samt oplysninger om, hvordan man stiller diagnosen og behandler sygdommen. 
The CHMP therefore recommended that a warning should be included in the product information on trimetazidine-induced parkinsonism, its diagnosis and management.
Udvalget anbefalede desuden at gøre trimetazidin kontraindiceret hos patienter med Parkinsons sygdom eller parkinsonsymptomer og hos patienter med svært nedsat nyrefunktion. 
It also recommended contraindicating trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
• Lægerne bør ikke længere ordinere trimetazidin til behandling af tinnitus, vertigo og synsforstyrrelser, men overføre patienterne til en egnet alternativ behandling. 
• Prescribers should no longer prescribe trimetazidine for treating tinnitus, vertigo and disturbances in vision and switch patients to appropriate alternative treatment.
• Patienter, der aktuelt får trimetazidin mod tinnitus, vertigo og synsforstyrrelser, bør kontakte deres læge med henblik på at skifte til en egnet alternativ behandling. 
• Patients currently receiving trimetazidine for tinnitus, vertigo and disturbances in vision should consult their doctor so they can switch to an appropriate alternative treatment.
Til anvendelse mod tinnitus, vertigo og synsfeltforstyrrelser opvejer fordelene ikke længere risiciene, og udvalget anbefalede, at disse anvendelser ikke længere bør være godkendt. 
For use in tinnitus, vertigo and visual field disturbances, the benefits no longer outweigh the risks and the CHMP recommended that these uses should no longer be authorised.
Trimetazidin anvendes desuden til behandling af symptomer på vertigo (svimmelhed) og tinnitus (ringen for ørerne) samt til behandling af nedsat synsskarphed og synsfeltforstyrrelser, som skyldes problemer, der påvirker blodkarrene. 
Trimetazidine is also used to treat the symptoms of vertigo (a spinning sensation) and tinnitus (ringing sensation in the ears), and to treat reduced vision and visual field disturbances (unclear or disturbed vision) due to problems affecting the blood vessels.
Desuden bemærkede CHMP, at trimetazidin ofte anvendes til behandling af disse sygdomme hos ældre patienter i længere tid og med højere doser end anbefalet. 
In addition the CHMP noted that trimetazidine is often used to treat these conditions in older patients for longer and at higher doses than recommended, increasing the risk of side effects such as falls which undermines the use of trimetazidine for these conditions.
• Lægerne må ikke ordinere trimetazidin til patienter med Parkinsons sygdom eller parkinsonsymptomer eller til patienter med svært nedsat nyrefunktion. 
• Prescribers must not prescribe trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
• Trimetazidin bør kun anvendes til symptomatisk behandling af angina pectoris og kun som tillægsbehandling til eksisterende behandlinger hos patienter, der ikke kan kontrolleres tilstrækkeligt med andre lægemidler mod angina pectoris eller ikke tåler disse. 
• Trimetazidine should only be used in the symptomatic treatment of angina pectoris, and only as add-on to existing treatments in patients who are not adequately controlled by or who are intolerant to other medicines for angina pectoris.
Efter at have vurderet de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende trimetazidin fortsat opvejer risiciene, når de anvendes som tillægsbehandling hos patienter med angina pectoris. 
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of trimetazidine continue to outweigh its risks when used as add-on treatment in patients with angina pectoris, but that changes should be made to the product information to ensure the safe use of these medicines.
En analyse af de pågældende sikkerhedsdata viste, at det ikke kan udelukkes, at der forekommer bevægelsesforstyrrelser med trimetazidin, herunder parkinsonisme. 
An analysis of relevant safety data showed that movement disorders, including Parkinsonism, cannot be excluded with trimetazidine, although these are not common and are reversible after discontinuing trimetazidine.
Undersøgelserne påviste ikke, at fordelene opvejede risiciene ved anvendelse af trimetazidin alene eller som førstevalgsbehandling, men de understøttede anvendelsen af trimetazidin som tillægsbehandling til eksisterende behandling af patienter, der ikke er kontrolleret tilstrækkeligt med andre lægemidler mod angina pectoris eller ikke tåler disse. 
Although the studies did not show that the benefits outweighed the risks for trimetazidine when used alone as first-line treatment, the studies supported the use of trimetazidine as add-on to existing treatments in patients who are not adequately controlled by or intolerant to other medicines for angina pectoris.
Anfaldene består i pludselige smerter i brystet, kæben og ryggen, som opstår ved fysisk anstrengelse og skyldes nedsat blodforsyning til hjertet. 
Trimetazidine is a medicine used to prevent angina attacks, which are sudden pains to the chest, jaw and back brought on by physical effort, due to reduced blood flow to the heart.
En af de vigtigste betænkeligheder var, at virkningen af trimetazidin ikke er påvist overbevisende for nogen af de godkendte indikationer. 
A main concern was that the effectiveness of trimetazidine had not been convincingly demonstrated in any of the authorised indications, since the studies supporting the authorised uses had several methodological weaknesses and only showed a small benefit.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene fortsat opvejer risiciene hos patienter med angina pectoris. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits continue to outweigh the risks in patients with angina pectoris but that treatment should be restricted to add-on to existing treatments in patients who are not adequately controlled by or who are intolerant to other medicines for angina pectoris.
Dette sammendrag blev sidst ajourført i 06-2014. 
This summary was last updated in 06-2014.
• svære bevægelsesvanskeligheder. 
• severe dyskinesia.
Det fås som tabletter (100 mg and 200 mg). 
It is available as tablets (100 mg and 200 mg).
Tabletterne skal synkes hele. 
The tablets should be swallowed whole.
Den fuldstændige EPAR for Tasmar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Tasmar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tasmar. 
This is a summary of the European public assessment report (EPAR) for Tasmar.
Den anbefalede dosis er 100 mg tre gange dagligt. 
The recommended dose is 100 mg three times a day.
De indledende undersøgelser viste, at Tasmar var mere effektivt end placebo. 
The initial studies showed that Tasmar was more effective than placebo.
Patienterne mister derved evnen til at styre deres bevægelser. 
The patients then lose their ability to control their movements reliably.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tasmar den 27. august 1997. 
The European Commission granted a marketing authorisation valid throughout the European Union for Tasmar on 27 August 1997.
Tasmar blev oprindelig undersøgt hos i alt 594 patienter i to 13-ugers undersøgelser og en 6-ugers undersøgelse. 
Tasmar was originally studied in a total of 594 patients, in two 13-week studies and one six-week study.
Der er udarbejdet en risikostyringsplan for at sikre, at Tasmar anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Tasmar is used as safely as possible.
Tasmar må ikke anvendes til patienter med: 
Tasmar must not be used in patients with:
Andre oplysninger om Tasmar 
Other information about Tasmar
Hvis der efter tre uger ikke kan ses nogen væsentlig fordel af behandlingen med Tasmar, bør behandlingen afbrydes. 
If after three weeks, no substantial benefit has been seen, treatment with Tasmar should be stopped.
Dosis af Tasmar kan øges til 200 mg tre gange dagligt, men kun, når den forventede fordel opvejer risikoen for beskadigelse af leveren. 
The dose of Tasmar may be increased to 200 mg three times a day but only when the benefit expected outweighs the risk of liver injury.
Tasmar tolcapon 
Tasmar tolcapone
Patienten skal derfor overvåges meget omhyggeligt af lægen under behandlingen. 
Doctors should monitor patients very carefully during treatment.
• tegn på leversygdom eller forhøjede leverenzymer, 
• signs of liver disease or increased liver enzymes;
I undersøgelsen af lægemiddelskift virkede Tasmar hos flere patienter (53 %, 40 ud af 75) end entacapon (43 %, 32 ud af 75). 
In the switch study, more patients responded to Tasmar (53%; 40 out of 75) than to entacapone (43%; 32 out of 75).
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Tasmar skal anvendes. 
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tasmar.
Tasmar er et lægemiddel, der indeholder det aktive stof tolcapon. 
Tasmar is a medicine that contains the active substance tolcapone.
Den første dosis daglige dosis af Tasmar skal gives sammen den første daglige dosis af levodopapræparatet, og efterfølgende doser af Tasmar skal gives ca. 6 og 12 timer senere. 
The first dose of the day of Tasmar should be taken together with the first daily dose of the levodopa preparation, and subsequent doses of Tasmar should be given approximately 6 and 12 hours later.
Disse patienter fik i forvejen en kombination af levodopa og entacapon (et andet lægemiddel, der blokerer COMT). 
These patients were already receiving a combination of levodopa and entacapone (another medicine that blocks COMT).
Tasmar blev desuden undersøgt i en undersøgelse med lægemiddelskift hos 150 patienter. 
Tasmar has also been studied in a ‘switch' study in 150 patients.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tasmar? 
What measures are being taken to ensure the safe and effective use of Tasmar?
Lægen skal kontrollere patientens lever forud for behandlingen med Tasmar og jævnligt i løbet af behandlingen. 
Doctors should check the patient's liver before starting treatment with Tasmar and then regularly during treatment.
Dette medvirker til at mindske tegnene og symptomerne på Parkinsons sygdom såsom stivhed og langsomme bevægelser. 
This helps to improve the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Tasmar. 
The Committee recommended that Tasmar be given marketing authorisation.
Behandling med Tasmar må kun ordineres og skal overvåges af en læge med erfaring i behandling af fremskreden Parkinsons sygdom. 
Tasmar treatment should only be prescribed and supervised by a doctor who has experience in the management of advanced Parkinson's disease.
Hvis du ønsker yderligere oplysninger om behandling med Tasmar, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Tasmar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
I undersøgelsen sammenlignedes virkningen af at fortsætte på entacapon eller at skifte til Tasmar. 
The study compared continuing to take entacapone with switching to Tasmar.
Tasmar anvendes kun, når lægemidler af samme type ikke virker eller ikke kan anvendes til patienten. 
Tasmar is only used when patients do not respond, or cannot take other medicines of the same type.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Tasmar, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tasmar, including the appropriate precautions to be followed by healthcare professionals and patients.
Det aktive stof i Tasmar, tolcapon, genopretter indholdet af dopamin i de dele af hjernen, der styrer bevægelser og koordination. 
The active substance in Tasmar, tolcapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination.
Det primære effektmål var, i hvor lang tid patienterne var i "on"- eller ”off”tilstand. 
The main measure of effectiveness was how long the patients spent in the ‘off' or in the ‘on' state.
Hos patienter med Parkinsons sygdom begynder de celler i hjernen, der producerer neurotransmitteren dopamin, at dø, og hjernens dopaminindhold falder. 
In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Hvilken risiko er der forbundet med Tasmar? 
What is the risk associated with Tasmar?
Tasmar må ikke anvendes til patienter, der behandles med lægemidler, der kaldes ikke-selektive monoaminoxidasehæmmere. 
Tasmar must also not be used in patients who are being treated with medicines known as nonselective monoamine oxidase (MAO) inhibitors.
Tasmar kan beskadige leveren, i sjældne tilfælde med døden til følge. 
Tasmar can cause liver injury, which can be fatal in rare cases.
Den fuldstændige liste over begrænsninger fremgår af indlægssedlen. 
For the full list of restrictions see the package leaflet.
Det primære effektmål var antallet af patienter, der opnåede en forlængelse af "on"-perioden på mindst en time i løbet af tre uger efter lægemiddelskiftet. 
The main measure of effectiveness was the number of patients with an increase in ‘on' time of one hour or more, during the three weeks following the switch.
Parkinsons sygdom er en fremadskridende hjernesygdom, der medfører rysten, langsomme bevægelser og muskelstivhed. 
Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
• tidligere malignt neuroleptikasyndrom (en farlig nervesygdom, der sædvanligvis skyldes antipsykotiske lægemidler), rhabdomyolyse (nedbrydning af muskelfibrene) eller hedeslag, 
• a history of neuroleptic malignant syndrome (a dangerous nervous disorder usually caused by antipsychotic medicines), rhabdomyolysis (breakdown of muscle fibres) or hyperthermia (heat stroke);
Tasmar anvendes sammen med andre standardlægemidler til behandling af Parkinsons sygdom (enten en kombination af levodopa og benserazid eller en kombination af levodopa og carbidopa), når patienterne får ”fluktuationer”' hen mod slutningen af perioden mellem to doser af standardkombinationen. 
Tasmar is used together with other standard treatments for Parkinson's disease (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patients have ‘fluctuations' towards the end of the period between two doses of their standard combination.
De hyppigste bivirkninger ved Tasmar (som optræder hos flere end 1 ud af 10 patienter) er kvalme, appetitløshed, diarré, bevægelsesvanskeligheder, muskeltrækninger, hovedpine, svimmelhed, søvnforstyrrelser, forstærket drømmetendens, søvnighed, forvirring, sansebedrag og svimmelhed i oprejst stilling. 
The most common side effects with Tasmar (seen in more than 1 patient in 10) are nausea (feeling sick), loss of appetite, diarrhoea, dyskinesia (uncontrollable movements), dystonia (muscle spasms), headache, dizziness, sleep disorders, excessive dreaming, somnolence (sleepiness), confusion, hallucination (seeing things that are not there) and orthostatic complaints (dizziness on standing).
Når Tasmar gives som tillægsbehandling til den Parkinson-behandling, patienterne får i forvejen, skal de gøres opmærksom på, at de kan få nogle af bivirkningerne ved levodopa, men at dette ofte kan afhjælpes ved at mindske levodopa-dosis. 
When patients add Tasmar to their existing anti Parkinson's disease medication, they need to be made aware that they may experience some of the side effects of levodopa, although these can often be reduced by lowering the dose of levodopa.
Tasmar anvendes til behandling af Parkinsons sygdom. 
Tasmar is used to treat patients with Parkinson's disease.
Tasmar anvendes altid i kombination med enten levodopa og benserazid eller med levodopa og carbidopa. 
Tasmar is always given with levodopa and benserazide or with levodopa and carbidopa.
Hvad er Tasmar? 
What is Tasmar?
Hvorfor blev Tasmar godkendt? 
Why has Tasmar been approved?
Den fuldstændige liste over alle de indberettede bivirkninger ved Tasmar fremgår af indlægssedlen. 
For the full list of all side effects reported with Tasmar, see the package leaflet.
I alle undersøgelserne sammenlignedes Tasmar med placebo (en virkningsløs behandling) som tillægsbehandling til den behandling, patienten fik i forvejen (levodopa og enten carbidopa eller benserazid). 
All of the studies compared Tasmar with placebo (a dummy treatment) when they were added to the patient's existing medication (levodopa and either carbidopa or benserazide).
Tolcapon blokerer et enzym catechol-O-methyltransferase (COMT), som medvirker ved nedbrydningen af levodopa i kroppen. 
Tolcapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catecholO-methyl transferase (COMT).
• fæokromocytom (en svulst i binyrerne), 
• phaeochromocytoma (a tumour of the adrenal gland);
CHMP konkluderede, at fordelene ved Tasmar opvejer risiciene som tillægsbehandling til levodopa/benserazid eller levodopa/carbidopa hos patienter med levodopa-følsom Parkinsons sygdom af ukendt årsag og motoriske fluktuationer og som ikke reagerer på eller tolerer andre COMT-hæmmere. 
The CHMP decided that Tasmar's benefits are greater than its risks in combination with levodopa/benserazide or levodopa/carbidopa 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.
Fluktuationer er forbundet med den aftagende virkning af levodopa, der for patienten medfører pludselige skift mellem "on-perioder", hvor patienten kan bevæge sig, og "off-perioder", hvor patienten er immobil. 
Fluctuations are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and immobile.
Levodopa svarer til neurotransmitteren dopamin, som kan tages gennem munden. 
It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Hvad anvendes Tasmar til? 
What is Tasmar used for?
Derved forlænges virkningen af levodopa. 
As a result, levodopa remains active for longer.
Hvordan blev Tasmar undersøgt? 
How has Tasmar been studied?
Hos patienter, som fik Tasmar, bevirkede det, at "off"-perioderne blev reduceret med 20 til 30 %. 
There was a reduction of about 20 to 30% in ‘off' time in patients taking Tasmar.
Hvilken fordel viser undersøgelserne, at der er ved Tasmar? 
What benefit has Tasmar shown during the studies?
Hvordan anvendes Tasmar? 
How is Tasmar used?
Hvis patienten får leverproblemer, skal behandlingen afbrydes. 
Treatment should be stopped in patients who develop liver problems.
Hvordan virker Tasmar? 
How does Tasmar work?
Medlemslandene skal sikre, at indehaveren af markedsføringstilladelsen (MAH) vil forsyne alle læger, som forventes at ordinere/anvende Leflunomide medac, med en undervisningspakke for læger indeholdende følgende: 
The Member States shall ensure that the Marketing Authorisation Holder (MAH) will provide physicians who are expected to prescribe/use Leflunomide medac with a physician educational pack containing the following:
Informationen i folderen bør oplyse om reduktion af dosis, afbrydelse af behandling samt udvaskningsprocedure. 
The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures.
Læger og patienter skal gøres opmærksomme på, at der findes en ad hocinformationsservice, som rådgiver i forbindelse med laboratorietests af leflunomid i plasma 
Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing
• At der er risiko for teratogen effekt og at svangerskab derfor skal undgås, indtil plasmaniveauet af leflunomid er passende. 
• That there is a risk of teratogenicity and so pregnancy must be avoided until leflunomide plasma levels are at an appropriate level.
Informationsfolderen til læger bør indeholde følgende nøgleinformation: 
The Physician Leaflet should contain the following key messages:
• Information om den identificerede risiko for synergistisk hepato- eller hæmatotoksicitet forbundet med kombinationsbehandling med andre DMARDs (Disease-Modifying Antirheumatic Drugs) (f.eks. methotrexat) 
• The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
• At der er risiko for alvorlig leverskade, og det derfor er vigtigt med regelmæssige målinger af ALAT (SGPT) for at overvåge leverfunktionen. 
• That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
• Behovet for rådgivning af patienter om vigtige risici i forbindelse med behandling med leflunomid og passende forholdsregler under behandlingen. 
• The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
• Produktresumé • Informationsfolder til læger 
• The Summary of Product Characteristics • Physician Leaflet
Udløbsdatoen refererer til den sidste dag i den pågældende måned. 
The expiry date refers to the last day of that month.
Ingen kendte. 
None known.
Genopretning sker normalt inden for 24-36 timer efter behandling. 
Recovery occurs normally within 24-36 hours after treatment.
Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/. 
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Disse bivirkninger vil sædvanligvis forsvinde uden behandling. 
These effects will usually resolve without treatment.
0,5 Minimum 15 Minimum 48 
0.5 Minimum of 15 Minimum of 48
Tørre hvide rester kan også ses. 
A dry white residue may also be observed.
ATCvet kode: QP53AC54. 
ATCvet code: QP53AC54.
Batch {nummer} 
Batch {number}
1 pipette 4 pipetter 6 pipetter 
1 pipette 4 pipettes 6 pipettes
Administrationsmetode: 
Method of administration:
Alle hunde i husstanden bør behandles med et egnet loppemiddel. 
All dogs in a household should be treated with a suitable flea product.
• administrer lægemidlet et sted, hvor der er god ventilation 
• administer the product in a well-ventilated area;
Kun til anvendelse på hundens hud. 
For application to the dog's skin only.
• brug beskyttelseshandsker ved håndtering eller administration af lægemidlet 
• wear protective gloves when handling or applying the product;
EXP {måned/år} 
EXP {month/year}
I tilfælde af utilsigtet eksponering hos katte: 
In case of accidental exposure of cats:
Imidlertid kan potentiel overførsel af smitsomme sygdomme fra sandfluer ikke udelukkes, hvis forholdene er ugunstige. 
However, potential transmission of infectious disease by sand flies cannot be excluded if conditions are unfavourable.