FrancophonIA/ELRC3.0 huggingface dataset:
English: The study showed that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients' lives: patients taking the three medicines together lived for around 6.1 months, compared with 4.2 months for patients taking 5-fluorouracil plus leucovorin, and 4.9 months for patients taking Onivyde alone.
Estonian: Uuring tõendas, et Onivyde lisamine 5fluorouratsiili ja leukovoriini sisaldavale raviskeemile pikendas patsientide elumust: kolme ravimit koos kasutanud patsiendid elasid ligikaudu 6,1 kuud, 5-fluorouratsiili ja leukovoriini kasutanud patsiendid 4,2 kuud ja ainult Onivydet kasutanud patsiendid 4,9 kuud.
English: Patients were given Onivyde or 5-fluorouracil plus leucovorin, or the three medicines in combination.
Estonian: Patsientidele manustati Onivydet või 5-fluorouratsiili ja leukovoriini või neid kolme ravimit koos.
English: Onivyde was investigated in one main study involving 417 patients with metastatic adenocarcinoma of the pancreas whose cancer got worse despite cancer treatment that contained gemcitabine.
Estonian: Onivydet uuriti ühes põhiuuringus, kus osales 417 kõhunäärme metastaatilise adenokartsinoomiga patsienti, kelle vähk oli süvenenud vaatamata gemtsitabiini sisaldavale vähiravile.
English: Pancreatic cancer is rare, and Onivyde was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 December 2011.
Estonian: Kõhunäärmevähk esineb harva ja Onivyde nimetati 9. detsembril 2011 harvikravimiks.
English: The most common serious side effects (which may affect more than 1 in 50 people) included diarrhoea, nausea and vomiting, neutropenia and fever, infections of blood or lungs (sepsis, pneumonia), shock, dehydration, kidney failure and thrombocytopenia (low levels of blood platelets).
Estonian: Kõige sagedamad rasked kõrvalnähud (võivad esineda enam kui 1 patsiendil 50st) on kõhulahtisus, iiveldus ja oksendamine, neutropeenia ja palavik, sepsis või kopsupõletik, šokk, dehüdratsioon, neerupuudulikkus ja trombotsütopeenia (trombotsüütide ehk vereliistakute vähesus).
English: How does Onivyde work?
Estonian: Kuidas Onivyde toimib?
English: How is Onivyde used?
Estonian: Kuidas Onivydet kasutatakse?
English: The most common side effects with Onivyde (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, weakness, anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth) and fever.
Estonian: Onivyde kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 5st) on kõhulahtisus, iiveldus, oksendamine, isutus, neutropeenia (neutrofiilide ehk teatud valgeliblede vähesus), väsimus, nõrkus, aneemia (erütrotsüütide ehk vere punaliblede vähesus), stomatiit (suulimaskesta põletik) ja palavik.
English: The active substance in Onivyde, irinotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Estonian: Onivyde toimeaine irinotekaan on topoisomeraasiinhibiitorite rühma kuuluv vähiravim.
English: Onivyde is used together with 5-fluorouracil and leucovorin (two other cancer medicines) in adults whose cancer has got worse despite treatment containing the cancer medicine gemcitabine.
Estonian: Onivydet kasutatakse koos 5-fluorouratsiiliga ja leukovoriiniga (samuti vähiravimid) täiskasvanud patsientidel, kellel vähk on süvenenud vaatamata gemtsitabiini (samuti vähiravim) sisaldavale ravile.
English: Onivyde is a cancer medicine that is used to treat a form of pancreatic cancer called metastatic adenocarcinoma of the pancreas.
Estonian: Onivyde on vähiravim, mida kasutatakse teatud liiki kõhunäärmevähi, kõhunäärme metastaatilise adenokartsinoomi raviks.
English: For the full list of side effects of Onivyde, see the package leaflet.
Estonian: Onivyde kõrvalnähtude täielik loetelu on pakendi infolehel.
English: An overview of Onivyde and why it is authorised in the EU
Estonian: Ülevaade ravimist Onivyde ja ELis müügiloa väljastamise põhjendus
English: In Onivyde, irinotecan is contained within tiny fat particles called ‘liposomes'.
Estonian: Onivydes sisaldub irinotekaan väikestes rasvaosakestes liposoomides.
English: What benefits of Onivyde have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Onivyde kasulikkus?
English: Onivyde is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Estonian: Onivydet turustatakse infusioonilahuse (veeni tilgutatava lahuse) kontsentraadina.
English: The Agency considered that the increase in survival seen when Onivyde was used together with 5-fluorouracil and leucovorin was meaningful in previously treated patients with metastatic adenocarcinoma of the pancreas, for whom limited treatment options are available; the safety profile of Onivyde is in line with that of standard irinotecan, and the side effects manageable.
Estonian: Amet leidis, et kui Onivydet kasutati koos 5-fluorouratsiili ja leukovoriiniga varem ravitud kõhunäärme metastaatilise adenokartsinoomiga patsientidel, kelle ravivõimalused on piiratud, suurenes nende patsientide elumus oluliselt.
English: The full EPAR for Imatinib Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Imatinib Accordi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Accord on 1 July 2013.
Estonian: Euroopa Komisjon andis Imatinib Accordi müügiloa, mis kehtib kogu Euroopa Liidus, 1. juulil 2013.
English: What measures are being taken to ensure the safe and effective use of Imatinib Accord?
Estonian: Mis meetmed võetakse, et tagada Imatinib Accordi ohutu ja efektiivne kasutamine?
English: Imatinib Accord is available as tablets (100 and 400 mg).
Estonian: Imatinib Accordi turustatakse tablettidena (100 ja 400 mg).
English: Imatinib Accord is a cancer medicine used to treat the following diseases:
Estonian: Imatinib Accord on ravim, mida kasutatakse järgmiste haiguste raviks:
English: What is Imatinib Accord and what is it used for?
Estonian: Mis on Imatinib Accord ja milleks seda kasutatakse?
English: By blocking these receptors, Imatinib Accord helps to control cell division.
Estonian: Nende retseptorite blokeerimisega aitab Imatinib Accord piirata rakkude jagunemist.
English: As for every medicine, the company provided studies on the quality of Imatinib Accord.
Estonian: Nagu iga ravimi korral, esitas ettevõte uuringud ravimi Imatinib Accord kvaliteedi kohta.
English: Imatinib Accord is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Estonian: Imatinib Accordi manustatakse suu kaudu söögi ajal koos suure klaasitäie veega, et vähendada mao ja soole ärrituse riski.
English: Imatinib Accord imatinib
Estonian: Imatinib Accord imatiniib
English: These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Estonian: Neid ensüüme leidub vähiraku pinna teatud retseptorites, sealhulgas retseptorites, mis osalevad rakkude vohamise stimuleerimises.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Imatinib Accord has been shown to have comparable quality and to be bioequivalent to Glivec.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Imatinib Accord võrdväärne kvaliteet ja bioekvivalentsus ravimiga Glivec.
English: Because Imatinib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Imatinib Accord on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alfa (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Estonian: Ravimit kasutatakse täiskasvanutel ja lastel ka haiguse kroonilises faasis, kui ei teki alfainterferoonile (samuti vähiravim) ravivastust või kui haigus on süvenenud (aktseleratsioonifaasis või blastses kriisis);
English: This means that Imatinib Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Estonian: See tähendab, et Imatinib Accord sisaldab sama toimeainet ja toimib samal viisil kui võrdlusravim Glivec, millel juba on Euroopa Liidus müügiluba.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine, Glivec.
Estonian: Ettevõte tegi ka uuringud, mis tõendasid ravimi bioekvivalentsust võrdlusravimiga Glivec.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Accord have been included in the summary of product characteristics and the package leaflet.
Estonian: Imatinib Accordi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Accord.
Estonian: Võrdlusravimiga Glivec on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Imatinib Accord korrata.
English: Why is Imatinib Accord approved?
Estonian: Miks Imatinib Accord heaks kiideti?
English: The Agency recommended that Imatinib Accord be approved for use in the EU.
Estonian: Ravimiamet soovitas Imatinib Accordi kasutamise Euroopa Liidus heaks kiita.
English: It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Estonian: Ravimit kasutatakse ainuravimina ka Ph+ ALL-i raviks täiskasvanutel, kelle haigus on pärast varasemat ravi taastunud või kellel ei teki muude ravimitega ravivastust;
English: Therefore, the Agency's view was that, as for Glivec, the benefit outweighs the identified risk.
Estonian: Seetõttu on ravimiamet arvamusel, et nagu ka Gliveci korral, ületab ravimi Imatinib Accord kasulikkus sellega kaasnevad riskid.
English: For practical information about using Imatinib Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Imatinib Accordi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Estonian: • müelodüsplastilised või müeloproliferatiivsed haigused (MD/MPD) - haiguste rühm, mille korral organismis tekib suurel hulgal ebanormaalseid vererakke.
English: Imatinib Accord is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Estonian: Imatinib Accordi kasutatakse Philadelphia-kromosoom-positiivsetel (Ph+) patsientidel.
English: For more information about treatment with Imatinib Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Imatinib Accordiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: It is not intended to provide practical advice on how to use Imatinib Accord.
Estonian: Hindamisaruandes ei anta Imatinib Accordi kasutamise praktilisi nõuandeid.
English: Imatinib Accord contains the active substance imatinib.
Estonian: Imatinib Accord sisaldab toimeainena imatiniibi.
English: Imatinib Accord is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Estonian: Imatinib Accordi kasutatakse protuberantse dermatofibrosarkoomiga täiskasvanute raviks, kui sarkoomi ei saa kirurgiliselt eemaldada, kui kasvaja on pärast ravi taastunud või on siiretega (levinud organismis mujale).
English: Imatinib Accord is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for bone marrow transplantation.
Estonian: Imatinib Accordi kasutatakse täiskasvanutel ja lastel, kellel on äsja diagnoositud Philadelphia kromosoomiga krooniline müeloidleukeemia (Ph+ CML) ja kellele ei saa siirata luuüdi.
English: • advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Estonian: • edasiarenenud hüpereosinofiilia sündroom (HES) või krooniline eosinofiilne leukeemia (CEL)haigused, mille korral eosinofiilid (teatud leukotsüüdid) hakkavad takistamatult vohama.
English: Other information about Imatinib Accord
Estonian: Muu teave Imatinib Accordi kohta
English: This is a summary of the European public assessment report (EPAR) for Imatinib Accord.
Estonian: See on ravimi Imatinib Accord Euroopa avaliku hindamisaruande kokkuvõte.
English: It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours.
Estonian: Imatinib Accord on retseptiravim ja ravi tohib alustada üksnes verevähi või soliidtuumoritega patsientide ravis kogenud arst.
English: • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Estonian: • protuberantne dermatofibrosarkoom (DFSP) - vähiliik (sarkoom), mille korral nahaaluskoe rakud vohavad.
English: How does Imatinib Accord work?
Estonian: Kuidas Imatinib Accord toimib?
English: Imatinib Accord is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Estonian: Imatinib Accordi kasutatakse kaugelearenenud hüpereosinofiilse sündroomi või kroonilise eosinofiilse leukeemiaga täiskasvanute ravimiseks, kellel on kaks geeni (FIP1L1 ja PDGFRα) teataval viisil muundunud;
English: Imatinib Accord is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Estonian: Imatinib Accordi kasutatakse müelodüsplastiliste või müeloproliferatiivsete haigustega täiskasvanute ravimiseks, kellel on trombotsüütide kasvuteguri retseptori (PDGFR) geen muundunud;
English: How has Imatinib Accord been studied?
Estonian: Kuidas Imatinib Accordi uuriti?
English: What are the benefits and risks of Imatinib Accord?
Estonian: Milles seisneb Imatinib Accordi kasulikkus ja mis riskid ravimiga kaasnevad?
English: Imatinib Accord is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Estonian: Imatinib Accordi kasutatakse koos teiste vähiravimitega täiskasvanute ja laste raviks, kellel on äsja diagnoositud Philadelphiakromosoom-positiivne akuutne lümfoblastne leukeemia (Ph+ ALL).
English: The active substance in Imatinib Accord, imatinib, is a protein-tyrosine kinase inhibitor.
Estonian: Imatinib Accordi toimeaine imatiniib on proteiintürosiinkinaasiinhibiitor.
English: How is Imatinib Accord used?
Estonian: Kuidas Imatinib Accordi kasutatakse?
English: It is a ‘generic medicine'.
Estonian: Imatinib Accord on geneeriline ravim.
English: In such a case, treatment must be stopped immediately.
Estonian: Sellisel juhul tuleb ravi kohe lõpetada.
English: Available at: https://www.aace.com/files/late-breaking-abstracts2014.pdf
Estonian: Vt: https://www.aace.com/files/late-breaking-abstracts2014.pdf
English: However, an in-depth review did not find any conclusive evidence that this was the case.
Estonian: Põhjaliku läbivaatamise käigus ei leitud aga sellekohaseid veenvaid tõendeid.
English: The review of testosterone was initiated on 27 March 2014 at the request of Estonia, under Article 31 of Directive 2001/83/EC.
Estonian: 27. märtsil 2014 algatati Eesti taotlusel testosterooni sisaldavate ravimite direktiivi 2001/83/EÜ artikli 31 kohane hindamine.
English: Information to patients
Estonian: Tervishoiutöötajate teave
English: Possible signs and symptoms include incomplete sexual development, decreased sexual function, infertility, fatigue, depressed mood, mild anaemia, reduced muscle bulk and strength and increased body fat.
Estonian: Võimalikud tunnused ja sümptomid on muu hulgas puudulik seksuaalne areng, vähenenud seksuaalfunktsioon, viljatus, väsimus, meeleolu langus, kerge aneemia, vähenenud lihasmass ja -jõud ning suurenenud keharasva hulk.
English: Taking all the data into account, the signal for an increased cardiovascular risk associated with the use of testosterone remains weak and inconclusive.
Estonian: Võttes arvesse kõiki andmeid, on signaal testosterooni kasutamisega seotud suurenenud kardiovaskulaarse riski kohta endiselt nõrk ja ebaselge.
English: • Relevant safety and efficacy data in patients with age-related hypogonadism and established physiological reference values in older patients are lacking, and further studies are needed.
Estonian: • Puuduvad asjakohased andmed ohutuse ja efektiivsuse kohta vanusega seotud hüpogonadismiga patsientidel ja kindlaks määratud füsioloogilised kontrollväärtused vanematel patsientidel ning vaja on täiendavaid uuringuid.
English: • Patients who have any concerns about their treatment should discuss them with their doctor or pharmacist.
Estonian: • Küsimuste korral peaksid patsiendid pidama nõu oma arsti või apteekriga.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 November 2014 EMA/706140/2014
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21.
English: 1 The Coordination Group for Mutual Recognition and Decentralised Procedures - Human
Estonian: 1 Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm.
English: • Patients who are prescribed testosterone should remind their doctors if they are being treated for high blood pressure, as testosterone can also increase blood pressure.
Estonian: • Patsiendid, kellele on testosteroon välja kirjutatud, peavad oma arstile meelde tuletama, kui nad saavad kõrge vererõhu vastast ravi, sest testosteroon võib samuti vererõhku tõsta.
English: It follows concerns over reports about side effects of these medicines on the heart.
Estonian: Selles käsitletakse probleeme seoses teadetega nende ravimite südamele avalduvate kõrvalnähtudega.
English: The PRAC considered these studies along with available data from other studies and analyses, and information on safety collected since marketing, and found that the evidence regarding the risk of heart problems was inconsistent: some studies suggested increased risk, while others did not, and some of the studies had problems with the design that limited the conclusions that could be drawn from them.
Estonian: Ravimiohutuse järelevalve riskihindamiskomitee arutas neid uuringuid koos teistest uuringutest ja analüüsidest kättesaadava teabega ja alates turustamisest kogutud ohutusandmetega, ning leidis, et südameprobleemide tekke riski tõendid ei ole järjepidevad: mõned uuringud näitasid suurenenud riski, teised aga mitte, ning mõnes uuringus oli probleeme ülesehitusega, mis seadis piirangud järeldustele, mida neist saaks tuletada.
English: Testosterone-containing medicines have been authorised in all EU Member States via national procedures under various trade names.
Estonian: Testosterooni sisaldavad ravimid on kõigis ELi liikmesriikides heaks kiidetud riikliku menetlusega eri kaubanduslike nimetuste all.
English: The review was started because of some recent studies suggesting an increase in heart problems in men using testosterone, compared with men not using it.
Estonian: Läbivaatamine algatati mõnede hiljutiste uuringute tõttu, milles osutatakse südameprobleemide esinemissageduse suurenemisele testosterooni kasutavatel meestel võrreldes meestega, kes seda ei kasuta.
English: The PRAC also noted that the lack of testosterone itself could increase the risk of heart problems.
Estonian: Ravimiohutuse järelevalve riskihindamiskomitee märkis ka, et testosteroonipuudus ise võib samuti südameprobleemide tekke riski suurendada.
English: • Testosterone replacement therapy should only be given when deficiency of the hormone has been confirmed by clinical features and biochemical tests.
Estonian: • Testosteroonasendusravi tuleks teha vaid juhul, kui hormooni puudust on kinnitanud kliinilised tunnused ja biokeemilised analüüsid.
English: A review of these data was first conducted by the PRAC, the EMA's Committee responsible for the evaluation of safety issues for human medicines.
Estonian: Need andmed vaatas kõigepealt läbi ravimiohutuse järelevalve riskihindamiskomitee, EMA inimravimite ohutusega seotud küsimuste hindamise eest vastutav komitee.
English: Haemoglobin, haematocrit, liver function and blood lipid profile should also be monitored regularly.
Estonian: Samuti tuleb regulaarselt jälgida hemoglobiini ja hematokriti sisaldust, maksatalitlust ja vere lipiidide profiili.
English: • Some recent studies have suggested that using testosterone may increase a man's risk of heart attacks or other serious effects on the heart and circulation.
Estonian: • Mõnes hiljutises uuringus on osutatud, et testosterooni kasutamine võib suurendada mehe südameinfarkti või südamele ja vereringele mõjuvate teiste raskete toimete riski.
English: • In patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.
Estonian: • Raske südame-, maksa- või neerupuudulikkusega või südame isheemiatõvega patsientidel võib testosteroonravi tekitada raskeid tüsistusi, millele on iseloomulik turse koos südame paispuudulikkusega või ilma.
English: • As a precaution, the product information for these medicines will be updated with the latest information on the risks together with some additional warnings for safe use, and the safety of the medicines will continue to be closely monitored.
Estonian: • Ettevaatusabinõuna ajakohastatakse ravimiteavet uusima riskiteabega ja mõnede lisahoiatustega ohutuks kasutamiseks ning ravimite ohutust jälgitakse jätkuvalt suure tähelepanuga.
English: • The cardiovascular safety of testosterone medicines will continue to be monitored and the findings of ongoing studies will be reflected in the next regular benefit-risk assessments when available.
Estonian: • Testosterooni sisaldavate ravimite kardiovaskulaarset ohutust jälgitakse edasi ja toimuvate uuringute kättesaadavaid tulemusi kajastatakse perioodilistes ohutusaruannetes.
English: The PRAC recommended updating the product information in line with the latest evidence and to provide warnings about those who might be at increased risk of heart problems.
Estonian: Ravimiohutuse järelevalve riskihindamiskomitee soovitas ajakohastada ravimiteavet kooskõlas uusimate tõenditega ja lisada hoiatused patsientidele, kellel võib olla südameprobleemide tekke suurenenud risk.
English: However, the product information is to be updated in line with the most current available evidence on safety, and with warnings that the lack of testosterone should be confirmed by signs and symptoms and laboratory tests before treating men with these medicines.
Estonian: Ravimiteavet tuleb siiski ajakohastada kooskõlas uusimate kättesaadavate ohutustõenditega ja lisada hoiatused, et enne meeste ravimist nende ravimitega peab testosteroonipuudus olema kinnitatud tunnuste, sümptomite ja laborianalüüsidega.