FrancophonIA/ELRC3.0 huggingface dataset:
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/12/750/001 Esmya
Estonian: Tugevus Ravimvorm Manustamistee Sisepakendi iseloomustus
English: 7 July 2011
Estonian: 7. juulil 2011
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Estonian: Muudetud direktiivi 2001/83/EÜ artikli 29 kohase esildismenetluse tulemus
English: The European Commission issued a decision on 7 July 2011.
Estonian: Euroopa Komisjon tegi otsuse x. juulil 2011.
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.
Estonian: Ameti inimravimite komitee otsustas, et ravimi Docetaxel Teva Generics kasulikkus on suurem kui sellega kaasnevad riskid ning ravimi müügiloa võib anda Madalmaades ning Austrias, Belgias, Bulgaarias, Eestis, Hispaanias, Iirimaal, Itaalias, Kreekas, Küprosel, Leedus, Lätis, Luksemburgis, Maltal, Poolas, Prantsusmaal, Rootsis, Rumeenias, Saksamaal, Slovakkias, Sloveenias, Soomes, Taanis, Tšehhi Vabariigis, Ungaris, Ühendkuningriigis ja Norras.
English: What are the conclusions of the CHMP?
Estonian: Mis on inimravimite komitee järeldused?
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).
Estonian: See on menetlus, mille käigus üks liikmesriik (viiteliikmesriik, käesoleval juhul Madalmaad) hindab ravimit, et otsustada, kas anda ravimile müügiluba, mis kehtib selles riigis ja ka teistes liikmesriikides (asjaomased liikmesriigid, käesoleval juhul kõik teised Euroopa Liidu liikmesriigid (välja arvatud Portugal) ja Norra).
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.
Estonian: Liikmesriigid ei jõudnud kokkuleppele ja Madalmaad tegid 29. juulil 2010 inimravimite komiteele esildise vahekohtumenetluse alustamiseks.
English: With the skeleton still in place, the cells cannot divide and they eventually die.
Estonian: Kui raku sisetoes püsib, ei saa rakk jaguneda ning lõpuks hävib.
English: What is Docetaxel Teva Generics?
Estonian: Mis on Docetaxel Teva Generics?
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.
Estonian: Docetaxel Teva Generics on välja töötatud järgmiste vähivormide ravimiseks: rinnavähk, mitteväikerakk-kopsuvähk, eesnäärmevähk, mao adenokartsinoom (maovähi vorm) ning pea ja kaela piirkonna vähk.
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.
Estonian: Seetõttu otsustas inimravimite komitee, et ravimi Docetaxel Teva Generics kasulikkus on suurem kui sellega kaasnevad riskid ja soovitas anda ravimi müügiloa Madalmaades ja asjaomastes liikmesriikides.
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).
Estonian: Mõned liikmesriigid pidasid seda uuringut vajalikuks, sest ravimi Docetaxel Teva Generics vorm (pulber ja lahusti, millest valmistatakse lahus) on teistsugune kui võrdlusravimil (kontsentreeritud lahus) ning need kaks ravimit sisaldavad erinevaid abiaineid (ravimi koostisaine, mis ei ole toimeaine).
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.
Estonian: Tuginedes praegu olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule, jõudis inimravimite komitee järeldusele, et täiendavaid andmeid ei ole vaja, sest eeldatavalt tekitab Docetaxel Teva Generics organismis sama toimeaine sisalduse kui võrdlusravim.
English: Docetaxel Teva Generics is a generic medicine based on a ‘reference medicine', Taxotere, which has an EU-wide marketing authorisation since 1995.
Estonian: Docetaxel Teva Generics on geneeriline ravim, mille võrdlusravimil Taxotere on müügiluba kogu Euroopa Liidus alates 1995. aastast.
English: Teva Generics BV submitted an application for Docetaxel Teva Generics to the Netherlands for a decentralised procedure.
Estonian: Teva Generics BV esitas Madalmaadele taotluse ravimi Docetaxel Teva Generics detsentraliseeritud menetluse teostamiseks.
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.
Estonian: Euroopa Ravimiamet on lõpetanud vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele ravimi Docetaxel Teva Generics heakskiitmises.
English: Docetaxel Teva Generics is a medicine that contains the active substance docetaxel.
Estonian: Docetaxel Teva Generics on ravim, mis sisaldab toimeainena dotsetakseeli.
English: It is available as a powder and solvent to be made up into a solution for infusion (drip into a vein).
Estonian: Seda turustatakse pulbri ja lahustina, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: Why was Docetaxel Teva Generics reviewed?
Estonian: Miks ravimi Docetaxel Teva Generics taotlus uuesti üle vaadati?
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Estonian: Dotsetakseel mõjutab peale vähirakkude ka muid rakke, näiteks vererakke, mis võib põhjustada kõrvalnähte.
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.
Estonian: Esildise tegemise aluseks oli asjaolu, et tegemata oli bioekvivalentsuse uuring inimestel, näitamaks, et Docetaxel Teva Generics tekitab organismis sama toimeaine sisalduse kui Taxotere.
English: Docetaxel blocks the ability of cancer cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Estonian: Dotsetakseel pärsib vähiraku võimet lagundada raku sisetoest, et rakk saaks jaguneda ja paljuneda.
English: The active substance in Docetaxel Teva Generics, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Estonian: Ravimi Docetaxel Teva Generics toimeaine dotsetakseel kuulub vähiravimite taksaanide rühma.
English: The European Commission issued a decision on this opinion on 3 September 2012.
Estonian: Euroopa Komisjon tegi sellel arvamusel põhineva otsuse 3. septembril 2012.
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended
Estonian: Muudetud direktiivi 2001/83/EÜ artikli 31 kohase menetluse tulemus
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.
Estonian: Trimetasidiini sisaldavaid ravimeid on turustatud alates 1970. aastatest ja on praegu müügil Bulgaarias, Küprosel, Tšehhi Vabariigis, Taanis, Eestis, Prantsusmaal, Saksamaal, Kreekas, Ungaris, Iirimaal, Itaalias, Lätis, Leedus, Luksemburgis, Maltal, Poolas, Portugalis, Rumeenias, Slovakkias, Sloveenias ning Hispaanias.
English: They are marketed under the invented name Vastarel and other trade names.
Estonian: Neid turustatakse väljamõeldud nimetuse Vastrel ja muude kaubanduslike nimetuste all.
English: What is trimetazidine?
Estonian: Mis on trimetasidiin?
English: Why was trimetazidine reviewed?
Estonian: Miks trimetasidiini taotlus uuesti üle vaadati?
English: The full changes made to the information to doctors and patients are detailed here.
Estonian: Arstidele ja patsientidele mõeldud muudetud teave on siin.
English: What are the recommendations for patients?
Estonian: Mis on soovitused patsientidele?
English: If parkinsonian symptoms persist for more than four months after discontinuation, a neurologist's opinion should be sought.
Estonian: Kui parkinsonismi sümptomid püsivad üle 4 kuu pärast ravi katkestamist, tuleb pöörduda neuroloogi poole.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Estonian: • Kui patsientidel tekib mingeid küsimusi, tuleb pöörduda oma arsti või apteekri poole.
English: Written communication will be distributed to doctors at national level to inform them of the changes to the approved uses of trimetazidine.
Estonian: Arstidele saadetakse riiklikul tasemel kirjalik teade, et teatada neile trimetasidiini lubatud kasutusnäidustuste muudatused.
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.
Estonian: Peamine probleem oli, et trimetasidiini efektiivsust ei olnud veenvalt näidatud ühegi lubatud näidustuse korral, sest lubatud näidustusi toetavatel uuringutel oli mitmeid metodoloogilisi nõrkusi ja need näitasid ainult väikest kasulikkust.
English: To address the lack of long-term data on trimetazidine, a study investigating the long-term effects of trimetazidine will be carried out.
Estonian: Trimetasidiini pikaajaliste andmete puuduse tõttu viiakse läbi trimetasidiini pikaajaliste toimete uuring.
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.
Estonian: 2011. aasta aprillis leidis Prantsusmaa ravimiamet Prantsusmaal kogutud tõendite ülevaatamise alusel, et trimetasidiini sisaldavate ravimite riskid on suuremad kui kasulikkus kõigi lubatud näidustuste puhul.
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).
Estonian: Veel tekkisid probleemid seoses trimetasidiini sisaldavate ravimite ohutusega pärast teateid Parkinsoni sündroomi (rühm sümptomeid, mille hulka kuuluvad värisemine, liigutuste aeglus ja lihasjäikus) ja muude motoorsete häirete kohta, nagu treemor (värisemine), lihasjäikus ja kõndimishäired ning rahutute jalgade sündroom (häire, mille puhul patsiendil on kontrollimatu vajadus liigutada jäsemeid, et peatada ebamugavad, valusad või imelikud aistingud kehas, tavaliselt öösiti).
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.
Estonian: Inimravimite komitee vaatas läbi kliiniliste uuringute andmed, avaldatud kirjanduse, spontaansed kõrvalnähtude teated ja trimetasidiini sisaldavaid ravimeid turustavate ettevõtete esitatud andmed.
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).
Estonian: Trimetasidiin on metaboolne aine, mis toimib ainevahetusele (protsess, millega ained organismis lõhustatakse).
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)
Estonian: Trimetasidiini sisaldavate ravimite (20 mg tabletid, 35 mg toimeainet modifitseeritult vabastavad tabletid ja 20 mg/ml suukaudne lahus) läbivaatamise teave
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.
Estonian: Asjakohase ohutusteabe analüüs näitas, et trimetasidiini puhul ei saa välistada liikumishäireid, sealhulgas parkinsonismi, kuigi need ei ole sagedad ja on pärast trimetasidiini kasutamise lõpetamist pöörduvad.
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.
Estonian: Veel soovitas inimravimite komitee uusi vastunäidustusi ja hoiatusi ravimiga seotud liikumishäirete võimaliku riski vähendamiseks ning juhtimiseks.
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.
Estonian: Arvatakse, et see kaitseb müokardi isheemia (vähenenud südamelihase verevarustus) eest glükoosi lõhustamiskiiruse suurendamise teel.
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.
Estonian: Seetõttu palus Prantsusmaa ravimiamet 22. aprillil 2011. aastal inimravimite komiteelt arvamust trimetasidiini sisaldavate ravimite kasulikkuse ja riski tasakaalu kohta ning ravimite müügilubade säilitamise, muutmise, peatamise või tühistamise kohta kogu ELis.
English: Which data has the CHMP reviewed?
Estonian: Mis andmed inimravimite komitee läbi vaatas?
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.
Estonian: Neid sümptomeid täheldati mõnedel patsientidel, kellel puudus varasem Parkinsoni sündroomi anamnees; paljudel juhtudel kadusid sümptomid siis, kui patsiendid lõpetasid trimetasidiini võtmise.
English: • There is no need for an urgent change in treatment, but doctors should review their patients' treatment at their next routine appointment.
Estonian: • Puudub vajadus ravi kiireks muutmiseks, kuid arstid peavad üle vaatama oma patsientide ravi järgmisel rutiinsel visiidil.
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.
Estonian: Euroopa Ravimiamet lõpetas 21. juunil 2012 trimetasidiini ohutuse ja efektiivsuse läbivaatamise pärast efektiivsusprobleemide tekkimist ning teateid liikumishäirete (parkinsonismi sümptomid) esinemise kohta ravimite manustamisel.
English: For patients with moderately reduced kidney failure and elderly patients, the dose should be reduced.
Estonian: Keskmise neerupuudulikkusega patsientidel ja eakatel patsientidel tuleb annust vähendada.
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.
Estonian: Hoolimata hoiatuste rõhutamisest ravimiteabes oli Prantsusmaa ravimiamet mures, et trimetasidiini kasulikkus ei kaalu üles selle riske.
English: • There is no need for an urgent change in treatment, but doctors will review their patients' treatment at their next routine appointment.
Estonian: • Puudub vajadus ravi kiireks muutmiseks, kuid arstid vaatavad üle patsientide ravi järgmisel rutiinsel visiidil.
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.
Estonian: Tuginedes olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule, järeldas inimravimite komitee, et trimetasidiini kasulikkus ületab endiselt selle riske kasutamisel lisaravimina stenokardiaga patsientidel, kuid ravimiteabesse tuleb teha muudatused ravimite ohutu kasutamise tagamiseks.
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.
Estonian: Seoses trimetasidiini kasutamisega stenokardia korral märkis inimravimite komitee, et toime näitamiseks läbi viidud uuringutel olid teatud puudused ja uuringud olid sageli lühiajalised.
English: • Trimetazidine should be discontinued permanently in patients who develop movement disorders such as parkinsonian symptoms.
Estonian: • Ravi trimetasidiiniga tuleb lõplikult katkestada patsientidel, kellel tekivad liikumishäired, näiteks parkinsonismi sümptomid.
English: The CHMP therefore recommended that a warning should be included in the product information on trimetazidine-induced parkinsonism, its diagnosis and management.
Estonian: Seetõttu soovitas inimravimite komitee lisada ravimiteabesse hoiatuse trimetasidiinist tingitud parkinsonismi, selle diagnoosimise ja ravi kohta.
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.
Estonian: • Patsiendid, kes praegu saavad trimetasidiini stenokardia raviks, peavad pidama nõu oma arstiga, et kontrollida, kas see on kõige optimaalsem ravi nende seisundi jaoks, ja minema vajaduse korral üle alternatiivsele ravile.
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.
Estonian: Uuringud, milles hinnati trimetasidiini kasutamist tinnituse, vertiigo ja nägemisvälja häirete korral, olid puuduliku metodoloogiaga ega näidanud trimetasidiini kliinilist kasulikkust võrreldes platseebo (näiv ravim) või alternatiivsete ravimitega.
English: • Prescribers should no longer prescribe trimetazidine for treating tinnitus, vertigo and disturbances in vision and switch patients to appropriate alternative treatment.
Estonian: • Arstid ei tohi enam määrata trimetasidiini tinnituse, vertiigo ja nägemishäirete raviks ning peavad patsiendid üle viima sobivale alternatiivsele ravile.
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.
Estonian: Veel märkis inimravimite komitee, et trimetasidiini kasutatakse sageli nende seisundite raviks eakamatel patsientidel pikema aja jooksul ja soovitatavatest suuremates annustes, mis suurendab kõrvalnähtude, näiteks kukkumiste riski.
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.
Estonian: • Patsiendid, kes praegu saavad trimetasidiini tinnituse, vertiigo ja nägemishäirete tõttu, peavad pidama nõu oma arstiga, et üle minna sobivale alternatiivsele ravile.
English: What are the recommendations for prescribers?
Estonian: Mis on soovitused arstidele?
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.
Estonian: Trimetasidiini kasutatakse samuti vertiigo (peapööritus) ja tinnituse (kohin kõrvus) sümptomite raviks ning veresooneprobleemide tõttu tekkinud nägemisvälja häirete (hägune või häiritud nägemine) raviks.
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.
Estonian: Kuigi uuringud ei näidanud, et trimetasidiini kasulikkus ületab riske kasutamisel esmavaliku ravimina, toetasid uuringud trimetasidiini kasutamist lisaravimina patsientidel, kelle sümptomeid ei saadud muude stenokardiaravimitega piisavalt kontrolli alla või kes ei talunud neid ravimeid.
English: • Prescribers must not prescribe trimetazidine in patients with Parkinson disease or parkinsonian symptoms and in patients with severely reduced kidney function.
Estonian: • Arstid ei tohi määrata trimetasidiini Parkinsoni tõvega või parkinsonismi sümptomitega patsientidele ja raske neerupuudulikkusega patsientidele.
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.
Estonian: Tinnituse, vertiigo ja nägemisvälja häirete sümptomaatiliseks raviks ei ületa kasulikkus enam riske ning inimravimite komitee soovituste alusel ei ole need kasutamisnäidustused enam lubatud.
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.
Estonian: Inimravimite komitee jõudis järeldusele, et tinnituse, vertiigo ja nägemisvälja häirete sümptomaatiliseks raviks ei ületa kasulikkus enam riske ning need kasutamisnäidustused ei ole enam lubatud.
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.
Estonian: • Trimetasidiini tohib kasutada ainult stenokardia sümptomaatiliseks raviks ja ainult olemasolevate ravimite lisaravimina patsientidel, kelle sümptomeid ei ole muude stenokardiaravimitega piisavalt kontrolli alla saadud või kes neid ravimeid ei talu.
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.
Estonian: Stenokardia on äkki tekkiv valu rindkeres, lõuas ja seljas verevoolu vähenemise tõttu südamesse, mille vallandab füüsiline pingutus.
English: Angina is commonly associated with a narrowing of the blood vessels that supply the heart, called the coronary arteries.
Estonian: Stenokardia on tavaliselt seotud südant varustavate veresoonte ehk pärgarterite ahenemisega.