natgillin/translations-raw huggingface dataset:
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.
Aprila 2011 je francoska regulativna agencija za zdravila ugotovila, da so na podlagi pregleda dokazov v Franciji tveganja v zvezi z zdravili, ki vsebujejo trimetazidin, večja od koristi za vse odobrene indikacije.
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.
Njen glavni pomislek je bil, da učinkovitost trimetazidina ni bila prepričljivo dokazana za nobeno od odobrenih indikacij, saj so imele študije za podporo dovoljeni uporabi več metodoloških slabosti in dokazale le majhno korist.
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.
Glede uporabe trimetazidina za zdravljenje angine pektoris je odbor ugotovil, da so študije, opravljene za prikaz njegovih učinkov, imele nekaj omejitev in da so bile pogosto kratkotrajne.
To address the lack of long-term data on trimetazidine, a study investigating the long-term effects of trimetazidine will be carried out.
Kot odziv na pomanjkanje dolgoročnih podatkov o trimetazidinu bo opravljena študija o dolgoročnih učinkih tega zdravila.
They are marketed under the invented name Vastarel and other trade names.
Tržijo se pod lastniškim imenom Vastarel in drugimi tržnimi imeni.
For patients with moderately reduced kidney failure and elderly patients, the dose should be reduced.
Bolnikom z zmerno zmanjšanim delovanjem ledvic in starejšim bolnikom je treba odmerek zmanjšati.
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.
21. junija 2012 je Evropska agencija za zdravila zaključila pregled varnosti in učinkovitosti trimetazidina po tem, ko so se pri uporabi zdravil s to učinkovino pojavili pomisleki glede njegove učinkovitosti in poročila o motnjah gibanja, kot so simptomi Parkinsonove bolezni.
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.
Zato je 22. aprila 2011 zaprosila odbor CHMP za izdajo mnenja o razmerju med tveganji in koristmi zdravil, ki vsebujejo trimetazidin, ter o tem, ali naj se dovoljenja za promet s temi zdravili v EU ohranijo, spremenijo, začasno prekličejo ali umaknejo.
If parkinsonian symptoms persist for more than four months after discontinuation, a neurologist's opinion should be sought.
Če simptomi Parkinsonove bolezni več kot štiri mesece po prenehanju uporabe zdravila ne izginejo, se je treba posvetovati z nevrologom.
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.
Domneva se, da ščiti pred miokardno ishemijo (zmanjšanim dotokom krvi v srčno mišico) tako, da poveča stopnjo razgradnje glukoze.
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.
Odbor CHMP je pregledal podatke iz kliničnih študij, objavljene literature in spontanih poročil o neželenih učinkih ter podatke, ki so jih predložile družbe, ki tržijo zdravila z vsebnostjo trimetazidina.
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.
Čeprav so v informacije o predpisovanju teh zdravil uvedli močnejša opozorila, je francosko agencijo še vedno skrbelo, da koristi trimetazidina ne odtehtajo njegovih tveganj.
• Trimetazidine should be discontinued permanently in patients who develop movement disorders such as parkinsonian symptoms.
• Trimetazidin je treba trajno ukiniti pri bolnikih, pri katerih se razvijejo motnje gibanja, kot so simptomi Parkinsonove bolezni.
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.
Kar zadeva uporabo trimetazidina pri tinitusu, vrtoglavici in motnjah vidnega polja, so imele študije slabo metodologijo in niso pokazale kliničnih koristi trimetazidina v primerjavi s placebom (zdravilom brez zdravilne učinkovine) ali alternativnimi zdravili.
Angina is commonly associated with a narrowing of the blood vessels that supply the heart, called the coronary arteries.
Angina pektoris je pogosto povezana z zoženjem krvnih žil, ki oskrbujejo srce in ki se imenujejo koronarne arterije.
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.
Analiza ustreznih podatkov o varnosti je pokazala, da pri uporabi trimetazidina ni mogoče izključiti motenj gibanja, vključno s parkinsonizmom, čeprav niso pogoste in po prenehanju zdravljenja izginejo.
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.
Te simptome so opazili pri nekaterih bolnikih, ki v anamnezi niso imeli Parkinsonovega sindroma, in so v številnih primerih izginili, ko so bolniki prenehali jemati trimetazidin.
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.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v okviru odbora je odbor CHMP zaključil, da koristi trimetazidina še vedno odtehtajo tveganja, kadar se uporablja kot dodatek k zdravljenju bolnikov z angino pektoris, vendar pa so za zagotovitev varne uporabe potrebne spremembe informacij o teh zdravilih.
Trimetazidine is a ‘metabolic agent', a medicine which has an effect on metabolism (the process by which substances are broken down in the body).
Trimetazidin je „presnovna učinkovina“, tj. zdravilo, ki vpliva na presnovo (postopek razgradnje snovi v telesu).
The CHMP therefore recommended that a warning should be included in the product information on trimetazidine-induced parkinsonism, its diagnosis and management.
Odbor CHMP je zato priporočil, da je v informacije o zdravilu treba vključiti opozorilo o parkinsonizmu, ki ga lahko povzroči trimetazidin, ter informacije o njegovem diagnosticiranju in obvladovanju.
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.
Poleg tega je odbor CHMP ugotovil, da se trimetazidin za zdravljenje teh bolezni pri starejših bolnikih pogosto uporablja dlje in v večjih odmerkih, kot je priporočeno, kar povečuje tveganje za pojav neželenih učinkov, npr. padcev, to pa ogroža uporabo trimetazidina pri teh boleznih.
It also recommended contraindicating trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
Priporočil je tudi kontraindikacijo za trimetazidin pri bolnikih s Parkinsonovo boleznijo ali simptomi Parkinsonove bolezni ter pri bolnikih z zelo zmanjšanim delovanjem ledvic.
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.
Trimetazidin je zdravilo za preprečevanje napadov angine pektoris, tj. nenadnih bolečin v prsih, čeljusti in hrbtu, ki jih povzroči telesni napor in so povezani z zmanjšanim dotokom krvi do srca.
• There is no need for an urgent change in treatment, but doctors will review their patients' treatment at their next routine appointment.
• Nujna sprememba zdravljenja ni potrebna, vendar bodo zdravniki pri naslednjem rutinskem pregledu znova ocenili zdravljenje svojih bolnikov.
• There is no need for an urgent change in treatment, but doctors should review their patients' treatment at their next routine appointment.
• Nujna sprememba zdravljenja ni potrebna, vendar morajo zdravniki pri naslednjem rutinskem pregledu svojih bolnikov zdravljenje znova oceniti.
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.
Trimetazidin se uporablja tudi za zdravljenje simptomov vrtoglavice (občutek vrtenja) in tinitusa (občutek zvonjenja v ušesih) ter za zdravljenje poslabšanega vida in motenj vidnega polja (zamegljen ali moten vid) kot posledice težav, ki vplivajo na krvne žile.
• Patients currently receiving trimetazidine for tinnitus, vertigo and disturbances in vision should consult their doctor so they can switch to an appropriate alternative treatment.
• Bolniki, ki trenutno dobivajo trimetazidin za zdravljenje tinitusa, vrtoglavice in motenj vida, se morajo posvetovati s svojim zdravnikom, da bodo lahko prešli na ustrezno alternativno zdravljenje.
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).
Poleg tega so se po poročilih o Parkinsonovem sindromu (skupina simptomov, ki vključuje tresenje, počasno gibanje in togost mišic) in drugih motoričnih motnjah, kot so tremor (tresenje), okorelost mišic in motnje hoje ter sindrom nemirnih nog (motnja, pri kateri ima bolnik nenadzorovano potrebo po premikanju okončin, da bi se znebil neprijetnih, bolečih ali nenavadnih občutkov v telesu, navadno ponoči), pojavili pomisleki glede varnosti zdravil, ki vsebujejo trimetazidin.
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.
Glede simptomatskega zdravljenja tinitusa, vrtoglavice in motenj vidnega polja je odbor CHMP zaključil, da koristi ne odtehtajo več tveganj in da te vrste uporabe ne smejo ostati odobrene.
• 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.
• Bolniki, ki trenutno dobivajo trimetazidin za zdravljenje angine pektoris, se morajo posvetovati s svojim zdravnikom, ki bo potrdil, da je njihovo zdravljenje najustreznejše, oziroma po potrebi poskrbel za drugo zdravljenje.
• Prescribers should no longer prescribe trimetazidine for treating tinnitus, vertigo and disturbances in vision and switch patients to appropriate alternative treatment.
• Zdravniki ne smejo več predpisovati trimetazidina za zdravljenje tinitusa, vrtoglavice in motenj vida, bolniki pa morajo preiti na ustrezno alternativno zdravljenje.
What are the recommendations for prescribers?
Kakšna so priporočila za zdravnike?
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.
Čeprav študije niso pokazale, da koristi trimetazidina odtehtajo tveganja, kadar se uporablja samostojno kot zdravljenje prve izbire, so podprle uporabo trimetazidina kot dodatka k obstoječemu zdravljenju bolnikov, katerih bolezen ni pod zadostnim nadzorom ali ki ne prenašajo drugih zdravil proti angini pektoris.
• Prescribers must not prescribe trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
• Zdravniki ne smejo predpisovati trimetazidina bolnikom s Parkinsonovo boleznijo ali simptomi Parkinsonove bolezni ter bolnikom z zelo zmanjšanim delovanjem ledvic.
• 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.
• Trimetazidin se sme uporabljati samo za simptomatsko zdravljenje angine pektoris in samo kot dodatek k obstoječim vrstam zdravljenja bolnikov, katerih bolezen ni dovolj pod nadzorom ali ki ne prenašajo drugih zdravil za zdravljenje angine pektoris.
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.
Pri zdravljenju tinitusa, vrtoglavice in motenj vidnega polja koristi ne odtehtajo več tveganj in odbor CHMP je priporočil, da te vrste uporabe ne smejo ostati odobrene.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA je presodil, da koristi še naprej odtehtajo tveganja pri bolnikih z angino pektoris, vendar pa je treba zdravljenje omejiti na dodatek k že obstoječemu zdravljenju bolnikov, katerih angina pektoris ni pod ustreznim nadzorom ali ki ne prenašajo drugih zdravil proti tej bolezni.
This summary was last updated in 06-2014.
Povzetek je bil nazadnje posodobljen 06-2014.
As a result, levodopa remains active for longer.
Posledično ostane levodopa aktivna dlje časa.
It is available as tablets (100 mg and 200 mg).
Na voljo je v obliki tablet (100 mg in 200 mg).
If after three weeks, no substantial benefit has been seen, treatment with Tasmar should be stopped.
Če po treh tednih ni opaziti nobene bistvene koristi, je treba zdravljenje z zdravilom Tasmar prekiniti.
The tablets should be swallowed whole.
Tablete je treba pogoltniti cele.
Doctors should monitor patients very carefully during treatment.
Zdravniki morajo bolnike med zdravljenjem skrbno spremljati.
Tasmar was originally studied in a total of 594 patients, in two 13-week studies and one six-week study.
Zdravilo Tasmar so najprej proučili pri skupaj 594 bolnikih v dveh 13-tedenskih študijah in eni šesttedenski študiji.
The European Commission granted a marketing authorisation valid throughout the European Union for Tasmar on 27 August 1997.
Evropska komisija je dovoljenje za promet z zdravilom Tasmar, veljavno po vsej Evropski uniji, odobrila dne 27. avgusta 1997.
The full EPAR for Tasmar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tasmar je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The initial studies showed that Tasmar was more effective than placebo.
Prvotne študije so pokazale, da je bilo zdravilo Tasmar učinkovitejše od placeba.
What measures are being taken to ensure the safe and effective use of Tasmar?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tasmar?
In the switch study, more patients responded to Tasmar (53%; 40 out of 75) than to entacapone (43%; 32 out of 75).
V študiji „prehoda“ se je več bolnikov odzvalo na zdravilo Tasmar (53 %, 40 od 75) kot na entakapon (43 %, 32 od 75).
The patients then lose their ability to control their movements reliably.
Bolniki nato izgubijo zmožnost zanesljivega nadzora nad svojimi gibi.
• signs of liver disease or increased liver enzymes;
• z znaki okvare jeter ali povečano ravnjo jetrnih encimov;
Tasmar has also been studied in a ‘switch' study in 150 patients.
Zdravilo Tasmar so proučevali tudi v študiji „prehoda“ pri 150 bolnikih.
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.
Odmerek zdravila Tasmar se sme povečati na 200 mg trikrat na dan, vendar samo če pričakovana korist odtehta tveganje za okvaro jeter.
This is a summary of the European public assessment report (EPAR) for Tasmar.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tasmar.
Doctors should check the patient's liver before starting treatment with Tasmar and then regularly during treatment.
Zdravniki morajo pregledati bolnikova jetra pred začetkom zdravljenja z zdravilom Tasmar ter nato redno med samim zdravljenjem.
For the full list of restrictions see the package leaflet.
Za celoten seznam omejitev glejte navodilo za uporabo.
Other information about Tasmar
Druge informacije o zdravilu Tasmar
A risk management plan has been developed to ensure that Tasmar is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Tasmar je bil pripravljen načrt obvladovanja tveganj.
• severe dyskinesia.
• s hudo diskinezijo.
Tasmar is only used when patients do not respond, or cannot take other medicines of the same type.
Zdravilo Tasmar se uporablja samo, kadar se bolnik ne odziva na druga zdravila iste vrste ali jih ne more jemati.
The study compared continuing to take entacapone with switching to Tasmar.
V študiji so primerjali nadaljevanje jemanja entakapona s prehodom na zdravilo Tasmar.
Tasmar treatment should only be prescribed and supervised by a doctor who has experience in the management of advanced Parkinson's disease.
Zdravljenje z zdravilom Tasmar mora predpisati in nadzorovati samo zdravnik z izkušnjami z zdravljenjem napredovale Parkinsonove bolezni.
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.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Tasmar shown during the studies?
Kakšne koristi je zdravilo Tasmar izkazalo med študijami?
For more information about treatment with Tasmar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Tasmar preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The Committee recommended that Tasmar be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Tasmar odobri dovoljenje za promet.
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.
Ko bolniki dodajajo zdravilo Tasmar svojemu obstoječemu zdravljenju Parkinsonove bolezni, morajo biti opozorjeni, da bodo morda občutili nekatere neželene učinke levodope, ki pa jih je pogosto možno ublažiti z zmanjšanjem njenega odmerka.
Tasmar must not be used in patients with:
Zdravila Tasmar ne smejo uporabljati bolniki:
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.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je vključitveno obdobje podaljšalo za eno uro ali več v treh tednih, ki so sledili prehodu na drugo zdravilo.
Tasmar is a medicine that contains the active substance tolcapone.
Tasmar je zdravilo, ki vsebuje zdravilno učinkovino tolkapon.
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).
Najpogostejši neželeni učinki zdravila Tasmar (opaženi pri več kot 1 bolniku od 10) so navzeja (slabost), izguba teka, driska, diskinezija (nekontrolirani gibi), distonija (krči v mišicah), glavobol, omotica, motnje spanja, pretirano sanjanje, zaspanost, zmedenost, halucinacije (prividi) in ortostatične motnje (vrtoglavica v stoječem položaju).
Tasmar must also not be used in patients who are being treated with medicines known as nonselective monoamine oxidase (MAO) inhibitors.
Zdravila Tasmar prav tako ne smejo jemati bolniki, ki jemljejo zdravila, znana kot neselektivni zaviralci monoaminooksidaze (MAO).
Tasmar is used to treat patients with Parkinson's disease.
Zdravilo Tasmar se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo.
This helps to improve the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
To pomaga pri izboljšanju znakov in simptomov Parkinsonove bolezni, kot sta otrplost mišic in upočasnjeno izvajanje gibov.
What is the risk associated with Tasmar?
Kakšna tveganja so povezana z zdravilom Tasmar?
Tasmar can cause liver injury, which can be fatal in rare cases.
Zdravilo Tasmar lahko povzroči okvaro jeter, ki je v redkih primerih lahko usodna.
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.
Priporočeni odmerek je 100 mg trikrat na dan. Prvi dnevni odmerek zdravila Tasmar je treba vzeti skupaj s prvim dnevnim odmerkom pripravka z levodopo, nadaljnje odmerke zdravila Tasmar pa je treba dati približno 6 in 12 ur kasneje.
The active substance in Tasmar, tolcapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination.
Zdravilna učinkovina v zdravilu Tasmar, tolkapon, deluje tako, da ponovno vzpostavi ravni dopamina v delu možganov, ki nadzoruje gibanje in njihovo usklajenost.
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.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
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.
Pri bolnikih s Parkinsonovo boleznijo začnejo celice v možganih, ki proizvajajo živčni prenašalec dopamin, odmirati, zato se količina dopamina v možganih zmanjša.