natgillin/translations-raw huggingface dataset:
Hos patienter med moderat nedsat nyrefunktion og ældre patienter bør vælges en lavere dosis.
For patients with moderately reduced kidney failure and elderly patients, the dose should be reduced.
Derfor anmodede den franske lægemiddelstyrelse den 22. april 2011 CHMP om at afgive en udtalelse om risk/benefit-forholdet for lægemidler indeholdende trimetazidin og tage stilling til, om markedsføringstilladelserne for disse lægemidler bør opretholdes, ændres, suspenderes eller tilbagetrækkes i hele EU.
Consequently, on 22 April 2011 it asked the CHMP to issue an opinion on the benefit-risk balance of trimetzidine-containing medicines, and on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Desuden var der betænkeligheder vedrørende sikkerheden af lægemidler indeholdende trimetazidin som følge af indberetninger om Parkinsonisme (en gruppe symptomer bestående af rysten, langsomme bevægelser og muskelstivhed), og andre bevægelsesforstyrrelser såsom tremor (rysten), muskelstivhed og gangforstyrrelser samt “restless legs syndrome” (en tilstand, hvor patienten føler uimodståelig trang til at bevæge lemmerne for at standse ubehagelige, smertefulde eller mærkelige følelser i kroppen, sædvanligvis om natten).
In addition, there were concerns regarding the safety of trimetazidine-containing medicines following reports of Parkinson syndrome (a group of symptoms that include shaking, slow movement and muscle stiffness) and other motor disorders such as tremor (shaking), muscle rigidity and walking disorders, and restless legs syndrome (a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night).
CHMP vurderede data fra kliniske undersøgelser, den offentliggjorte faglitteratur, spontane indberetninger af bivirkninger og oplysninger indsendt af de virksomheder, der markedsfører lægemidler indeholdende trimetazidin.
The CHMP looked at data from clinical studies, the published literature, spontaneous reports of side effects and data submitted by the companies that market medicines containing trimetazidine.
• Behandlingen med trimetazidin bør permanent ophøre hos patienter, der udvikler bevægelsesforstyrrelser såsom parkinsonsymptomer.
• Trimetazidine should be discontinued permanently in patients who develop movement disorders such as parkinsonian symptoms.
Disse symptomer forekom hos nogle patienter, der ikke tidligere havde haft parkinsonisme, og i mange tilfælde forsvandt symptomerne, når patienterne holdt op med at tage trimetazidin.
These symptoms were seen in some patients with no previous history of Parkinson syndrome, and in many cases their symptoms resolved when they stopped taking trimetazidine.
Skønt advarslerne i ordineringsoplysningerne for disse lægemidler var blevet skærpet, var den franske lægemiddelstyrelse fortsat bekymret for, at fordelene ved trimetazidin ikke opvejede risiciene.
Despite strengthening the warnings in the prescribing information of these medicines, the French agency remained concerned that the benefits for trimetazidine did not outweigh its risks.
I april 2011 konkluderede den franske lægemiddelstyrelse efter en gennemgang af oplysningerne fra Frankrig, at risiciene ved lægemidler indeholdende trimetazidin er større end fordelene for alle de godkendte indikationer.
In April 2011, the French medicines regulatory agency concluded that, based on a review of the evidence in France, the risks of medicines containing trimetazidine were greater than the benefits for all the authorised indications.
Hvilke anbefalinger gives der til ordinerende læger?
What are the recommendations for prescribers?
De markedsføres bl.a. under særnavnet Vastarel.
They are marketed under the invented name Vastarel and other trade names.
Angina er almindeligvis forbundet med forsnævring af de blodkar, der forsyner hjertet (koronararterierne).
Angina is commonly associated with a narrowing of the blood vessels that supply the heart, called the coronary arteries.
Hvad konkluderede CHMP?
What are the conclusions of the CHMP?
• Der er ikke tvingende behov for at ændre behandlingen, men lægerne vil vurdere patienternes behandling ved næste planlagte besøg.
• There is no need for an urgent change in treatment, but doctors will review their patients' treatment at their next routine appointment.
Vedrørende anvendelse af trimetazidin til tinnitus, vertigo og synsfeltforstyrrelser var undersøgelserne af ringe kvalitet og viste ingen klinisk fordel ved trimetazidin ved sammenligning med placebo (virkningsløs behandling) eller med andre lægemidler.
Regarding the use of trimetazidine in tinnitus, vertigo and visual field disturbances, the studies had poor methodology and did not demonstrate a clinical benefit of trimetazidine when compared with placebo (a dummy treatment) or alternative medicines.
Trimetazidin er et “metabolisk stof”, dvs. et lægemiddel med virkning på stofskiftet.
Trimetazidine is a ‘metabolic agent', a medicine which has an effect on metabolism (the process by which substances are broken down in the body).
• Der er ikke tvingende behov for at ændre behandlingen, men lægerne bør vurdere patienternes behandling ved næste planlagte besøg.
• There is no need for an urgent change in treatment, but doctors should review their patients' treatment at their next routine appointment.
For symptomatisk behandling af tinnitus, vertigo og synsfeltforstyrrelser konkluderede CHMP, at fordelene ikke længere opvejer risiciene, og at disse anvendelser ikke længere bør være godkendt.
For the symptomatic treatment of tinnitus, vertigo and visual field disturbances, the CHMP concluded that the benefits no longer outweigh the risks and that these uses should no longer be authorised.
• Patienter, der aktuelt får trimetazidin mod angina pectoris, bør kontakte deres læge med henblik på at sikre, at det er den mest egnede behandling af deres sygdom, eller om nødvendigt skifte til en anden behandling.
• Patients currently receiving trimetazidine for angina pectoris should consult their doctor to ensure that it is the most appropriate treatment for their condition or to arrange alternative treatment if necessary.
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);