FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Docetaxel Teva Generics outweigh its risks, and that the marketing authorisation can be granted in the Netherlands as well as in Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom and Norway.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Docetaxel Teva Generics odtehtajo z njim povezana tveganja ter da se lahko dovoljenje za promet z zdravilom odobri na Nizozemskem ter v Avstriji, Belgiji, Bolgariji, na Cipru, Češkem, Danskem, v Estoniji, na Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Latviji, Litvi, Luksemburgu, Malti, na Poljskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji, na Švedskem, v Združenem kraljestvu in na Norveškem.
English: However, the Member States were not able to reach an agreement and the Netherlands referred the matter to the CHMP on 29 July 2010 for arbitration.
Slovenian: Vendar se države članice niso mogle doseči soglasja, zato je Nizozemska dne 29. julija 2010 zadevo napotila na CHMP v arbitražo.
English: in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance all other EU Member States (except Portugal) and Norway).
Slovenian: To je postopek, v katerem ena država članica („referenčna država članica“, v tem primeru Nizozemska) oceni zdravilo z namenom odobritve dovoljenja za promet z zdravilom, ki bo veljavno v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru vse druge države članice EU (razen Portugalske) in Norveška).
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Docetaxel Teva Generics.
Slovenian: Evropska agencija za zdravila je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Docetaxel Teva Generics.
English: With the skeleton still in place, the cells cannot divide and they eventually die.
Slovenian: Ker ogrodje ostane nespremenjeno, se celice ne morejo deliti in sčasoma odmrejo.
English: Docetaxel Teva Generics is a generic medicine based on a ‘reference medicine', Taxotere, which has an EU-wide marketing authorisation since 1995.
Slovenian: Zdravilo Docetaxel Teva Generics je generično zdravilo, ki temelji na „referenčnem zdravilu“ Taxotere, ki ima dovoljenje za promet po vsej EU od leta 1995.
English: Docetaxel blocks the ability of cancer cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Slovenian: Docetaksel zavira sposobnost rakastih celic, da uničijo notranje „ogrodje“, ki jim omogoča, da se delijo in množijo.
English: It is available as a powder and solvent to be made up into a solution for infusion (drip into a vein).
Slovenian: Na voljo je v obliki praška in topila za pripravo raztopine za infundiranje (dajanje v veno).
English: Docetaxel Teva Generics is intended to treat the following types of cancer: breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer), and head and neck cancer.
Slovenian: Zdravilo Docetaxel Teva Generics je namenjeno zdravljenju naslednjih vrst raka: rak dojke, nedrobnocelični rak pljuč, rak prostate, želodčni adenokarcinom (vrsta raka na želodcu) ter rak glave in vratu.
English: Based on an evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that additional data was not needed because Docetaxel Teva Generics is expected to produce comparable levels of the active substance in the body as the reference medicine.
Slovenian: Na podlagi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP sklenil, da dodatni podatki niso potrebni, saj naj bi zdravilo Docetaxel Teva Generics proizvajalo primerljive ravni zdravilne učinkovine v telesu kot referenčno zdravilo.
English: The CHMP therefore concluded that the benefits of Docetaxel Teva Generics outweigh its risks and recommended that the marketing authorisation be granted in the Netherlands and the concerned Member States.
Slovenian: CHMP je tako zaključil, da koristi zdravila Docetaxel Teva Generics odtehtajo z njim povezana tveganja in priporočil, da se zanj odobri dovoljenje za promet na Nizozemskem in v zadevnih državah članicah.
English: Why was Docetaxel Teva Generics reviewed?
Slovenian: Zakaj je bilo zdravilo Docetaxel Teva Generics pregledano?
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Slovenian: Docetaksel učinkuje tudi na nerakave celice, kot so krvne celice, kar lahko povzroči neželene učinke.
English: Some Member States considered this needed since the form of Docetaxel Teva Generics (a powder and a solvent to be made into a solution) is different to the form of the reference medicine (a concentrated solution) and the two medicines contain different excipients (inactive ingredients).
Slovenian: Nekatere države članice so menile, da je študija potrebna, saj se oblika zdravila Docetaxel Teva Generics (prašek in topilo za pripravo raztopine) razlikuje od oblike referenčnega zdravila (koncentrirana raztopina) ter da zdravili vsebujeta različne pomožne snovi (sestavine brez zdravilnih učinkovin).
English: Questions and answers on Docetaxel Teva Generics (docetaxel, 20 mg and 80 mg powder and solvent for solution for infusion) EMA/125006/2011 rev. 1
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Docetaxel Teva Generics (docetaksel, 20 mg in 80 mg prašek in topilo za raztopino za infundiranje) EMA/125006/2011 rev. 1
English: Questions and answers on Docetaxel Teva Generics (docetaxel, 20 mg and 80 mg powder and solvent for solution for infusion)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Docetaxel Teva Generics (docetaksel, 20 mg in 80 mg prašek in topilo za raztopino za infundiranje)
English: What is Docetaxel Teva Generics?
Slovenian: Kaj je zdravilo Docetaxel Teva Generics?
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.
Slovenian: Podlaga za napotitev je bilo dejstvo, da ni bila izvedena študija „biološke enakovrednosti“ pri ljudeh, ki bi dokazala, da zdravilo Docetaxel Teva Generics proizvaja primerljive ravni zdravilne učinkovine v telesu kot zdravilo Taxotere.
English: The active substance in Docetaxel Teva Generics, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Slovenian: Zdravilna učinkovina v zdravilu Docetaxel Teva Generics, docetaksel, spada v skupino zdravil proti raku, imenovanih taksani.
English: Docetaxel Teva Generics is a medicine that contains the active substance docetaxel.
Slovenian: Zdravilo Docetaxel Teva Generics je zdravilo, ki vsebuje zdravilno učinkovino docetaksel.
English: Teva Generics BV submitted an application for Docetaxel Teva Generics to the Netherlands for a decentralised procedure.
Slovenian: Družba Teva Generics BV je Nizozemski predložila vlogo za decentraliziran postopek za zdravilo Docetaxel Teva Generics.
English: The European Commission issued a decision on this opinion on 3 September 2012.
Slovenian: Evropska komisija je izdala odločbo o tem mnenju 3. septembra 2012.
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Slovenian: Izid postopka v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena
English: What is trimetazidine?
Slovenian: Kaj je trimetazidin?
English: The full changes made to the information to doctors and patients are detailed here.
Slovenian: Celotne spremembe informacij za zdravnike in bolnike so na voljo tukaj.
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.
Slovenian: Zdravila, ki vsebujejo trimetazidin, so na voljo od 1970-ih let ter se trenutno tržijo v Bolgariji, na Cipru, Češkem, Danskem, v Estoniji, Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Latviji,
English: • Patients who have any questions should speak to their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo s svojim zdravnikom ali farmacevtom.
English: What are the recommendations for patients?
Slovenian: Kakšna so priporočila za bolnike?
English: Why was trimetazidine reviewed?
Slovenian: Zakaj je bil trimetazidin pregledan?
English: Questions and answers on the review of medicines containing trimetazidine (20 mg tablets, 35 mg modified release tablet and 20 mg/ml oral solution)
Slovenian: Vprašanja in odgovori v zvezi s pregledom zdravil, ki vsebujejo trimetazidin (20 mg tablete, 35 mg tablete s prirejenim sproščanjem in peroralna raztopina 20 mg/ml)
English: Which data has the CHMP reviewed?
Slovenian: Katere podatke je odbor CHMP pregledal?
English: Written communication will be distributed to doctors at national level to inform them of the changes to the approved uses of trimetazidine.
Slovenian: Informacije bodo pisno predložene zdravnikom na nacionalni ravni, tako da bodo obveščeni o spremembah odobrene uporabe trimetazidina.
English: What are the conclusions of the CHMP?
Slovenian: Kakšni so zaključki odbora CHMP?
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.
Slovenian: Poleg tega je odbor priporočil nove kontraindikacije ter opozorila za zmanjšanje in obvladovanje morebitnega tveganja za motnje gibanja, ki so povezane z uporabo tega zdravila.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: To address the lack of long-term data on trimetazidine, a study investigating the long-term effects of trimetazidine will be carried out.
Slovenian: Kot odziv na pomanjkanje dolgoročnih podatkov o trimetazidinu bo opravljena študija o dolgoročnih učinkih tega zdravila.
English: They are marketed under the invented name Vastarel and other trade names.
Slovenian: Tržijo se pod lastniškim imenom Vastarel in drugimi tržnimi imeni.
English: For patients with moderately reduced kidney failure and elderly patients, the dose should be reduced.
Slovenian: Bolnikom z zmerno zmanjšanim delovanjem ledvic in starejšim bolnikom je treba odmerek zmanjšati.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: If parkinsonian symptoms persist for more than four months after discontinuation, a neurologist's opinion should be sought.
Slovenian: Če simptomi Parkinsonove bolezni več kot štiri mesece po prenehanju uporabe zdravila ne izginejo, se je treba posvetovati z nevrologom.
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.
Slovenian: Domneva se, da ščiti pred miokardno ishemijo (zmanjšanim dotokom krvi v srčno mišico) tako, da poveča stopnjo razgradnje glukoze.
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.
Slovenian: 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.
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.
Slovenian: Čeprav so v informacije o predpisovanju teh zdravil uvedli močnejša opozorila, je francosko agencijo še vedno skrbelo, da koristi trimetazidina ne odtehtajo njegovih tveganj.
English: • Trimetazidine should be discontinued permanently in patients who develop movement disorders such as parkinsonian symptoms.
Slovenian: • Trimetazidin je treba trajno ukiniti pri bolnikih, pri katerih se razvijejo motnje gibanja, kot so simptomi Parkinsonove bolezni.
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.
Slovenian: 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.
English: Angina is commonly associated with a narrowing of the blood vessels that supply the heart, called the coronary arteries.
Slovenian: Angina pektoris je pogosto povezana z zoženjem krvnih žil, ki oskrbujejo srce in ki se imenujejo koronarne arterije.
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
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).
Slovenian: Trimetazidin je „presnovna učinkovina“, tj. zdravilo, ki vpliva na presnovo (postopek razgradnje snovi v telesu).
English: The CHMP therefore recommended that a warning should be included in the product information on trimetazidine-induced parkinsonism, its diagnosis and management.
Slovenian: 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.
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.
Slovenian: 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.
English: It also recommended contraindicating trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
Slovenian: Priporočil je tudi kontraindikacijo za trimetazidin pri bolnikih s Parkinsonovo boleznijo ali simptomi Parkinsonove bolezni ter pri bolnikih z zelo zmanjšanim delovanjem ledvic.
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.
Slovenian: 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.
English: • There is no need for an urgent change in treatment, but doctors will review their patients' treatment at their next routine appointment.
Slovenian: • Nujna sprememba zdravljenja ni potrebna, vendar bodo zdravniki pri naslednjem rutinskem pregledu znova ocenili zdravljenje svojih bolnikov.
English: • There is no need for an urgent change in treatment, but doctors should review their patients' treatment at their next routine appointment.
Slovenian: • Nujna sprememba zdravljenja ni potrebna, vendar morajo zdravniki pri naslednjem rutinskem pregledu svojih bolnikov zdravljenje znova oceniti.
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.
Slovenian: 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.
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.
Slovenian: • 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.
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).
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: • 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.
English: • Prescribers should no longer prescribe trimetazidine for treating tinnitus, vertigo and disturbances in vision and switch patients to appropriate alternative treatment.
Slovenian: • Zdravniki ne smejo več predpisovati trimetazidina za zdravljenje tinitusa, vrtoglavice in motenj vida, bolniki pa morajo preiti na ustrezno alternativno zdravljenje.
English: What are the recommendations for prescribers?
Slovenian: Kakšna so priporočila za zdravnike?
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.
Slovenian: 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.
English: • Prescribers must not prescribe trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
Slovenian: • Zdravniki ne smejo predpisovati trimetazidina bolnikom s Parkinsonovo boleznijo ali simptomi Parkinsonove bolezni ter bolnikom z zelo zmanjšanim delovanjem ledvic.