FrancophonIA/ELRC3.0 huggingface dataset:
English: The grounds for the referral were that a ‘bioequivalence' study in humans, to show that Docetaxel Teva Generics produces comparable levels of the active substance in the body as Taxotere, had not been performed.
Danish: Begrundelsen for indbringelsen var, at der ikke var blevet foretaget en bioækvivalensundersøgelse hos mennesker med henblik på at påvise, at Docetaxel Teva Generics danner de samme mængder af det aktive stof i kroppen som Taxotere.
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Danish: Resultat af en procedure i henhold til artikel 31 i direktiv 2001/83/EF, som ændret
English: The European Commission issued a decision on this opinion on 3 September 2012.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 3. september 2012.
English: Medicines containing trimetazidine have been available since the 1970s and are currently marketed in Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Danish: Lægemidler indeholdende trimetazidin har været godkendt siden 1970'erne og markedsføres på nuværende tidspunkt i Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Spanien.
English: EMA/608974/2012 Rev 1 EMEA/H/A-31/1305
Danish: Den 3. september 2012 EMA/412151/2012 rev 1 EMEA/H/A-31/1305
English: What is trimetazidine?
Danish: Hvad er trimetazidin?
English: What are the recommendations for patients?
Danish: Hvilke anbefalinger gives der til patienterne?
English: Why was trimetazidine reviewed?
Danish: Hvorfor blev trimetazidin vurderet igen?
English: Which data has the CHMP reviewed?
Danish: Hvilke data vurderede CHMP?
English: To address the lack of long-term data on trimetazidine, a study investigating the long-term effects of trimetazidine will be carried out.
Danish: For at afhjælpe de manglende langsigtede oplysninger om trimetazidin vil der blive udført en undersøgelse af langtidsvirkningerne af trimetazidin.
English: The full changes made to the information to doctors and patients are detailed here.
Danish: Yderligere oplysninger om den ændrede produktinformation til læger og patienter findes her.
English: In addition, the Committee recommended new contraindications and warnings to reduce and manage the possible risk of movement disorders, associated with the use of this medicine.
Danish: Desuden anbefalede udvalget nye kontraindikationer og advarsler for at mindske og håndtere risikoen for bevægelsesforstyrrelser ved anvendelse af dette lægemiddel.
English: Regarding the use of trimetazidine in angina pectoris, the Committee noted that the studies carried out to show its effects had some limitations and were often of short duration.
Danish: Vedrørende anvendelse af trimetazidin til behandling af angina pectoris bemærkede udvalget, at de undersøgelser, der er udført til påvisning af dets virkninger, havde visse begrænsninger og ofte var af kort varighed.
English: If parkinsonian symptoms persist for more than four months after discontinuation, a neurologist's opinion should be sought.
Danish: Hvis parkinsonsymptomerne vedvarer længere end fire måneder efter ophør af behandlingen, bør patienten henvises til en neurolog.
English: Written communication will be distributed to doctors at national level to inform them of the changes to the approved uses of trimetazidine.
Danish: Læger underrettes skriftligt på nationalt plan om ændringerne i de godkendte anvendelser af trimetazidin.
English: It is believed to protect against myocardial ischaemia (reduced blood supply to the heart muscle) by increasing the rate at which glucose is broken down.
Danish: Det menes at beskytte mod myokardieiskæmi (nedsat blodforsyning til hjertemusklen) ved at øge nedbrydningshastigheden af glukose.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Danish: • Patienter, der ønsker yderligere oplysninger, bør kontakte deres læge eller apotek.
English: On 21 June 2012, the European Medicines Agency completed a review of the safety and effectiveness of trimetazidine following concerns over its effectiveness and reports of movement disorders such as parkinsonian symptoms with these medicines.
Danish: Den 21. juni 2012 afsluttede Det Europæiske Lægemiddelagentur en vurdering af sikkerheden og virkningen af trimetazidin som følge af betænkeligheder med hensyn til dets virkning og indberetninger om bevægelsesforstyrrelser såsom parkinsonsymptomer i forbindelse med disse lægemidler.
English: For patients with moderately reduced kidney failure and elderly patients, the dose should be reduced.
Danish: Hos patienter med moderat nedsat nyrefunktion og ældre patienter bør vælges en lavere dosis.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: CHMP vurderede data fra kliniske undersøgelser, den offentliggjorte faglitteratur, spontane indberetninger af bivirkninger og oplysninger indsendt af de virksomheder, der markedsfører lægemidler indeholdende trimetazidin.
English: • Trimetazidine should be discontinued permanently in patients who develop movement disorders such as parkinsonian symptoms.
Danish: • Behandlingen med trimetazidin bør permanent ophøre hos patienter, der udvikler bevægelsesforstyrrelser såsom parkinsonsymptomer.
English: 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.
Danish: 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.
English: 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.
Danish: Skønt advarslerne i ordineringsoplysningerne for disse lægemidler var blevet skærpet, var den franske lægemiddelstyrelse fortsat bekymret for, at fordelene ved trimetazidin ikke opvejede risiciene.
English: 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.
Danish: 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.
English: What are the recommendations for prescribers?
Danish: Hvilke anbefalinger gives der til ordinerende læger?
English: They are marketed under the invented name Vastarel and other trade names.
Danish: De markedsføres bl.a. under særnavnet Vastarel.
English: Angina is commonly associated with a narrowing of the blood vessels that supply the heart, called the coronary arteries.
Danish: Angina er almindeligvis forbundet med forsnævring af de blodkar, der forsyner hjertet (koronararterierne).
English: What are the conclusions of the CHMP?
Danish: Hvad konkluderede CHMP?
English: • There is no need for an urgent change in treatment, but doctors will review their patients' treatment at their next routine appointment.
Danish: • Der er ikke tvingende behov for at ændre behandlingen, men lægerne vil vurdere patienternes behandling ved næste planlagte besøg.
English: 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.
Danish: 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.
English: Trimetazidine is a ‘metabolic agent', a medicine which has an effect on metabolism (the process by which substances are broken down in the body).
Danish: Trimetazidin er et “metabolisk stof”, dvs. et lægemiddel med virkning på stofskiftet.
English: • There is no need for an urgent change in treatment, but doctors should review their patients' treatment at their next routine appointment.
Danish: • Der er ikke tvingende behov for at ændre behandlingen, men lægerne bør vurdere patienternes behandling ved næste planlagte besøg.
English: 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.
Danish: 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.
English: • 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.
Danish: • 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.
English: The CHMP therefore recommended that a warning should be included in the product information on trimetazidine-induced parkinsonism, its diagnosis and management.
Danish: 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.
English: It also recommended contraindicating trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
Danish: Udvalget anbefalede desuden at gøre trimetazidin kontraindiceret hos patienter med Parkinsons sygdom eller parkinsonsymptomer og hos patienter med svært nedsat nyrefunktion.
English: • Prescribers should no longer prescribe trimetazidine for treating tinnitus, vertigo and disturbances in vision and switch patients to appropriate alternative treatment.
Danish: • Lægerne bør ikke længere ordinere trimetazidin til behandling af tinnitus, vertigo og synsforstyrrelser, men overføre patienterne til en egnet alternativ behandling.
English: • Patients currently receiving trimetazidine for tinnitus, vertigo and disturbances in vision should consult their doctor so they can switch to an appropriate alternative treatment.
Danish: • Patienter, der aktuelt får trimetazidin mod tinnitus, vertigo og synsforstyrrelser, bør kontakte deres læge med henblik på at skifte til en egnet alternativ behandling.
English: 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.
Danish: Til anvendelse mod tinnitus, vertigo og synsfeltforstyrrelser opvejer fordelene ikke længere risiciene, og udvalget anbefalede, at disse anvendelser ikke længere bør være godkendt.
English: 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.
Danish: 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.
English: 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.
Danish: Desuden bemærkede CHMP, at trimetazidin ofte anvendes til behandling af disse sygdomme hos ældre patienter i længere tid og med højere doser end anbefalet.
English: • Prescribers must not prescribe trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
Danish: • Lægerne må ikke ordinere trimetazidin til patienter med Parkinsons sygdom eller parkinsonsymptomer eller til patienter med svært nedsat nyrefunktion.
English: • 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.
Danish: • 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.
English: 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.
Danish: 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.
English: 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.
Danish: En analyse af de pågældende sikkerhedsdata viste, at det ikke kan udelukkes, at der forekommer bevægelsesforstyrrelser med trimetazidin, herunder parkinsonisme.
English: 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.
Danish: 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.
English: 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.
Danish: Anfaldene består i pludselige smerter i brystet, kæben og ryggen, som opstår ved fysisk anstrengelse og skyldes nedsat blodforsyning til hjertet.
English: 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.
Danish: En af de vigtigste betænkeligheder var, at virkningen af trimetazidin ikke er påvist overbevisende for nogen af de godkendte indikationer.
English: 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.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene fortsat opvejer risiciene hos patienter med angina pectoris.
English: This summary was last updated in 06-2014.
Danish: Dette sammendrag blev sidst ajourført i 06-2014.
English: • severe dyskinesia.
Danish: • svære bevægelsesvanskeligheder.
English: It is available as tablets (100 mg and 200 mg).
Danish: Det fås som tabletter (100 mg and 200 mg).
English: The tablets should be swallowed whole.
Danish: Tabletterne skal synkes hele.
English: The full EPAR for Tasmar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tasmar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Tasmar.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tasmar.
English: The recommended dose is 100 mg three times a day.
Danish: Den anbefalede dosis er 100 mg tre gange dagligt.
English: The initial studies showed that Tasmar was more effective than placebo.
Danish: De indledende undersøgelser viste, at Tasmar var mere effektivt end placebo.
English: The patients then lose their ability to control their movements reliably.
Danish: Patienterne mister derved evnen til at styre deres bevægelser.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tasmar on 27 August 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tasmar den 27. august 1997.
English: Tasmar was originally studied in a total of 594 patients, in two 13-week studies and one six-week study.
Danish: Tasmar blev oprindelig undersøgt hos i alt 594 patienter i to 13-ugers undersøgelser og en 6-ugers undersøgelse.
English: A risk management plan has been developed to ensure that Tasmar is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Tasmar anvendes så sikkert som muligt.
English: Tasmar must not be used in patients with:
Danish: Tasmar må ikke anvendes til patienter med:
English: Other information about Tasmar
Danish: Andre oplysninger om Tasmar
English: If after three weeks, no substantial benefit has been seen, treatment with Tasmar should be stopped.
Danish: Hvis der efter tre uger ikke kan ses nogen væsentlig fordel af behandlingen med Tasmar, bør behandlingen afbrydes.
English: 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.
Danish: Dosis af Tasmar kan øges til 200 mg tre gange dagligt, men kun, når den forventede fordel opvejer risikoen for beskadigelse af leveren.
English: Tasmar tolcapone
Danish: Tasmar tolcapon
English: Doctors should monitor patients very carefully during treatment.
Danish: Patienten skal derfor overvåges meget omhyggeligt af lægen under behandlingen.
English: • signs of liver disease or increased liver enzymes;
Danish: • tegn på leversygdom eller forhøjede leverenzymer,
English: In the switch study, more patients responded to Tasmar (53%; 40 out of 75) than to entacapone (43%; 32 out of 75).
Danish: I undersøgelsen af lægemiddelskift virkede Tasmar hos flere patienter (53 %, 40 ud af 75) end entacapon (43 %, 32 ud af 75).
English: 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.
Danish: 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.
English: Tasmar is a medicine that contains the active substance tolcapone.
Danish: Tasmar er et lægemiddel, der indeholder det aktive stof tolcapon.
English: 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.
Danish: 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.
English: These patients were already receiving a combination of levodopa and entacapone (another medicine that blocks COMT).
Danish: Disse patienter fik i forvejen en kombination af levodopa og entacapon (et andet lægemiddel, der blokerer COMT).
English: Tasmar has also been studied in a ‘switch' study in 150 patients.
Danish: Tasmar blev desuden undersøgt i en undersøgelse med lægemiddelskift hos 150 patienter.
English: What measures are being taken to ensure the safe and effective use of Tasmar?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tasmar?
English: Doctors should check the patient's liver before starting treatment with Tasmar and then regularly during treatment.
Danish: Lægen skal kontrollere patientens lever forud for behandlingen med Tasmar og jævnligt i løbet af behandlingen.
English: This helps to improve the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Danish: Dette medvirker til at mindske tegnene og symptomerne på Parkinsons sygdom såsom stivhed og langsomme bevægelser.
English: The Committee recommended that Tasmar be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Tasmar.
English: Tasmar treatment should only be prescribed and supervised by a doctor who has experience in the management of advanced Parkinson's disease.
Danish: Behandling med Tasmar må kun ordineres og skal overvåges af en læge med erfaring i behandling af fremskreden Parkinsons sygdom.
English: For more information about treatment with Tasmar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: 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.
English: The study compared continuing to take entacapone with switching to Tasmar.
Danish: I undersøgelsen sammenlignedes virkningen af at fortsætte på entacapon eller at skifte til Tasmar.
English: Tasmar is only used when patients do not respond, or cannot take other medicines of the same type.
Danish: Tasmar anvendes kun, når lægemidler af samme type ikke virker eller ikke kan anvendes til patienten.