FrancophonIA/ELRC3.0 huggingface dataset:
English: It is already used in combination with other medicines to treat cancer of the colon or rectum (large intestine), breast cancer, non-small cell lung cancer and kidney cancer.
Estonian: Avastini kasutatakse koos teiste ravimitega käär- või pärasoole-, rinna-, mitteväikerakk-kopsuvähi ja neeruvähi ravis.
English: Avastin is a concentrate that is made up into a solution for infusion (drip into a vein).
Estonian: Avastin on kontsentraat, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Estonian: Avastini toimeaine bevatsisumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära teatud antigeeni (organismis leiduva spetsiifilise aine) ning seondub sellega.
English: Bevacizumab has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Estonian: Bevatsisumaab seondub endoteeli kasvuteguriga (VEGF), mis on vereringes leiduv valk, mis soodustab veresoonte kasvu.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Avastin for glioblastoma.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu Avastini glioblastoomi kliinilistes uuringutes osalevatele patsientidele tagasivõtmine mõju ei avalda.
English: Avastin was to be used in on its own or in combination with irinotecan (another anticancer medicine).
Estonian: Avastini kavatseti kasutada ainsa ravimina või koos irinotekaaniga (samuti vähiravim).
English: What are the consequences of the refusal for patients in clinical trials using Avastin?
Estonian: Kuidas mõjutab tagasivõtmine praegu Avastini kliinilistes uuringutes osalevaid patsiente?
English: It was to be used when the disease had relapsed (come back after previous treatment).
Estonian: Seda kavatseti kasutada glioblastoomiga patsientide ravis pärast relapsi (vähk on pärast varasemat ravi taastunud).
English: In glioblastoma, Avastin is expected to work in the same way as it does in its existing indications.
Estonian: Avastini eeldatav toime glioblastoomi ravis on samalaadne toimega näidustuste raviks, mille kohta on müügiluba juba antud.
English: It contains the active substance bevacizumab.
Estonian: Selle toimeaine on bevatsisumaab.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lixiana on 19 June 2015.
Estonian: Euroopa Komisjon andis Lixiana müügiloa, mis kehtib kogu Euroopa Liidus, 19. juunil 2015.
English: The full EPAR for Lixiana can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Lixiana kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Lixiana?
Estonian: Mis meetmed võetakse, et tagada Lixiana ohutu ja efektiivne kasutamine?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lixiana's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Lixiana kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: What is Lixiana and what is it used for?
Estonian: Mis on Lixiana ja milleks seda kasutatakse?
English: Why is Lixiana approved?
Estonian: Miks Lixiana heaks kiideti?
English: Lixiana edoxaban
Estonian: Lixiana edoksabaan
English: With respect to safety, overall the risk of serious bleeding such as bleeding into the brain was reduced compared with warfarin, although there may be less difference where warfarin treatment is well managed.
Estonian: Ohutuse seisukohalt vähenes varfariiniga võrreldes üldiselt raske verejooksu, nt ajuverejooksu risk, kuigi erinevus võib olla väiksem, kui varfariinravi on hästi juhitud.
English: What are the risks associated with Lixiana?
Estonian: Mis riskid Lixianaga kaasnevad?
English: Although there was greater a risk of bleeding from the mucosa (tissues lining body cavities such as the nose, gut and vagina), the Committee considered that the risk could be managed with appropriate measures.
Estonian: Kuigi limaskestade (kehaõõnsusi, nt nina, soolt ja tuppe katvad koed) verejooksu risk oli suurem, oli komitee seisukohal, et riski saab sobivate meetmetega vähendada.
English: Lixiana is available as tablets (15, 30 and 60 mg) and can only be obtained with a prescription.
Estonian: Lixianat turustatakse tablettidena (15, 30 ja 60 mg).
English: It must also not be used in pregnant or breastfeeding women or in patients also being treated with another anticoagulant.
Estonian: Samuti ei tohi seda kasutada rasedad ja rinnaga toitvad naised ega patsiendid, keda ravitakse ka teise hüübimisvastase ravimiga.
English: It is not intended to provide practical advice on how to use Lixiana.
Estonian: Hindamisaruandes ei anta Lixiana kasutamise praktilisi nõuandeid.
English: This is a summary of the European public assessment report (EPAR) for Lixiana.
Estonian: See on ravimi Lixiana Euroopa avaliku hindamisaruande kokkuvõte.
English: Lixiana must not be used in patients who are actively bleeding, have liver diseases that affect blood clotting, have severe uncontrolled high blood pressure or who have a condition putting them at significant risk of major bleeding.
Estonian: Lixianat ei tohi kasutada patsiendid, kellel on aktiivne verejooks, vere hüübimist mõjutavad maksahaigused, ohjamata väga kõrge vererõhk või haigus, mis põhjustab olulist suure verejooksu riski.
English: A first systemic embolism or stroke occurred in 182 patients given standard doses of Lixiana and in 232 of those given warfarin, corresponding to annual rates for these events of around 1.2% and 1.5% respectively.
Estonian: Esimene süsteemne emboolia või insult tekkis 182 Lixiana tavaannust saanud patsiendil ja 232 varfariini saanud patsiendil ning vastavad aastased määrad olid ligikaudu 1,2% ja 1,5%.
English: Lixiana contains the active substance edoxaban.
Estonian: Lixiana sisaldab toimeainena edoksabaani.
English: The company that markets Lixiana will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them.
Estonian: Lixianat turustav ettevõte varustab ravimit määravad arstid teabematerjalidega ja patsiendid hoiatuskaardiga, milles selgitatakse ravimi kasutamisega kaasneva verejooksu riski ja kuidas seda ohjata.
English: When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 143 patients given Lixiana (0.9%) and 157 given warfarin (1%).
Estonian: Kui kasutati teist insuldiliigi soovitatud määratlust, täheldati trombidest põhjustatud embooliat või insulti 143 Lixianat saanud patsiendil (0,9%) ja 157 varfariini saanud patsiendil (1%).
English: Dose adjustments may also need to be made in patients who are switched between Lixiana and other anticoagulant medicines.
Estonian: Annust võib olla vaja kohandada ka patsientidel, kes vahetavad Lixiana muude hüübimisvastaste ravimite vastu või vastupidi.
English: The most common side effects with Lixiana (which may affect up to 1 in 10 people) are bleeding from skin and soft tissues, nose bleeds (epistaxis) and the vagina.
Estonian: Lixiana kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on naha ja pehmete kudede veritsemine, ninaverejooks (epistaksis) ja tupeverejooks.
English: It will also carry out a study of the effects of the medicine in patients with atrial fibrillation and good kidney function.
Estonian: Samuti viib ettevõte läbi uuringu ravimi toime kohta kodade virvenduse ja hea neerufunktsiooniga patsientidel.
English: For more information about treatment with Lixiana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Lixianaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects reported with Lixiana, see the package leaflet.
Estonian: Lixiana kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lixiana have also been included in the summary of product characteristics and the package leaflet.Other information about Lixiana
Estonian: Lixiana ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Other common side effects are anaemia (low levels of red blood cells), rash, itching, headache, dizziness, belly pain and abnormal results in tests of liver function.
Estonian: Muud sagedad kõrvalnähud on aneemia (vere punaliblede vähesus), lööve, kihelus, peavalu, peapööritus, kõhuvalu ja maksatalitluse analüüside tulemuste kõrvalekalded.
English: There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.
Estonian: Tulemused olid paremad neerupuudulikkusega patsientidel võrreldes normaalse neerufunktsiooniga patsientidega.
English: For practical information about using Lixiana, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Lixiana kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How does Lixiana work?
Estonian: Kuidas Lixiana toimib?
English: What benefits of Lixiana have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Lixiana kasulikkus?
English: • to prevent stroke (caused by blood clots in the brain) and systemic embolism (blood clots in other organs) in patients with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
Estonian: • ajutrombist põhjustatud insuldi ja süsteemse emboolia (trombid muudes organites) ennetamiseks, kui neil on mittevalvulaarne kodade virvendusarütmia (südamekodade korrapäratu kiire kokkutõmbumine).
English: How is Lixiana used?
Estonian: Kuidas Lixianat kasutatakse?
English: The main measure of effectiveness was the number of patients who had another episode of DVT or pulmonary embolism during the study period.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel taastekkis uuringu kestel süvaveenitromboos või kopsuemboolia.
English: Lixiana has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation.
Estonian: On tõestatud, et Lixiana on kodade virvendusarütmiaga patsientidel insuldi ja süsteemse emboolia ennetamisel sama efektiivne kui tavapärane hüübimisvastane ravim varfariin.
English: However, the trend for its benefits in preventing stroke in atrial fibrillation to be less clear in those patients with high creatinine clearance (good kidney function) was considered to require further study.
Estonian: Siiski leiti, et täiendavalt tuleb uurida asjaolu, miks ei ole ravimi kasulikkus kodade virvendusega patsientidel insuldi ennetamisel sama selge patsientidel, kel on kiire kreatiniini kliirens (hea neerufunktsioon).
English: Lixiana is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:
Estonian: Lixiana on hüübimisvastane ravim, mida kasutatakse täiskasvanud patsientidel
English: This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin.
Estonian: Lixiana toimeaine edoksabaan on Xa-hüübimisfaktori inhibiitor, mis pärsib trombiini moodustumises osalevat Xa-hüübimisfaktoriks nimetatavat ensüümi.
English: In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Lixiana was also found to be as effective as warfarin, in a study involving over 8,200 patients.
Estonian: Rohkem kui 8200 patsienti hõlmanud uuringus oli Lixiana süvaveenitromboosi või kopsuembooliaga patsientide trombivastases ravis ja ennetamises sama efektiivne kui varfariin.
English: Ref.: EMEA/487740/2009 EMEA/H/C/1059
Estonian: Viide: EMEA/487724/2009 EMEA/H/C/1059
English: The European Commission granted a marketing authorisation valid throughout the EU for Grepid to Pharmathen S.A. on 28 July 2009.
Estonian: Euroopa Komisjon andis Grepidi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Pharmathen S.A. 28. juulil 2009.
English: Grepid can be given to the following groups of patients:
Estonian: Grepidit saab kasutada järgmiste patsiendirühmade korral:
English: The standard dose of Grepid is one 75 mg tablet once a day, taken with or without food.
Estonian: Grepidi tavaannus on üks 75 mg tablett üks kord ööpäevas koos toiduga või ilma.
English: Grepid can be started between seven days and six months after the stroke;
Estonian: Grepidi manustamist saab alustada seitsme päeva kuni kuue kuu jooksul pärast insulti;
English: Grepid clopidogrel EPAR summary for the public
Estonian: Grepid klopidogreel Kokkuvõte üldsusele
English: The Committee recommended that Grepid be given marketing authorisation.
Estonian: Komitee soovitas anda Grepidile müügiloa.
English: Other information about Grepid:
Estonian: Muu teave Grepidi kohta
English: Why has Grepid been approved?
Estonian: Miks Grepid heaks kiideti?
English: Grepid is a ‘generic medicine'.
Estonian: Grepid on geneeriline ravim.
English: Because Grepid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Estonian: Et Grepid on geneeriline ravim ja võrdlusravimiga bioekvivalentne, loetakse selle kasulikkust ja sellega kaasnevaid riske samasugusteks kui võrdlusravimil.
English: What is Grepid?
Estonian: Mis on Grepid?
English: This means that Grepid is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Estonian: See tähendab, et Grepid on sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
English: What are the benefit and risk of Grepid?
Estonian: Milles seisneb Grepidi kasulikkus ja mis riskid ravimiga kaasnevad?
English: The full EPAR for Grepid can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Grepidi kohta leiate siit.
English: Grepid is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Estonian: Grepidit kasutatakse aterotrombootiliste nähtude (trombide ehk soonesiseste verehüüvete moodustumisest ja arterite lubjastumisest põhjustatud probleemide) ennetamiseks täiskasvanutel.
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Plavixi puhul, ületab Grepidi kasulikkus sellega kaasnevad riskid.
English: Grepid is a medicine that contains the active substance clopidogrel.
Estonian: Grepid on ravim, mis sisaldab toimeainena klopidogreeli.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Grepid has been shown to have comparable quality and to be bioequivalent to Plavix.
Estonian: Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Grepidi võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
English: Because Grepid is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Estonian: Et Grepid on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Grepidi bioekvivalentsust võrdlusravimiga Plavix.
English: How is Grepid used?
Estonian: Kuidas Grepidit kasutatakse?
English: This means that it helps to prevent blood clots from forming.
Estonian: See aitab ennetada organismis trombide tekkimist.
English: How has Grepid been studied?
Estonian: Kuidas Grepidit uuriti?
English: Grepid can be started between a few days and 35 days after the attack;
Estonian: Grepidi manustamist saab alustada mõne kuni 35
English: The active substance in Grepid, clopidogrel, is an inhibitor of platelet aggregation.
Estonian: Grepidi toimeaine klopidogreel on trombotsüütide agregatsiooni inhibiitor.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries).
Estonian: • perifeersete arterite haigusega (arteriverevoolu probleemiga) patsiendid; Seda ravimit saab üksnes retsepti alusel.
English: What is Grepid used for?
Estonian: Milleks Grepidit kasutatakse?
English: How does Grepid work?
Estonian: Kuidas Grepid toimib?
English: It is given 21 to 49 days after transplantation, but only if the transplant has not already restored the patient's immune system and if the patient has not developed graft-versus-host disease (when transplanted cells attack the body).
Estonian: Seda manustatakse 21-49 päeva pärast siirdamist, kuid ainult juhul, kui siirik ei ole juba taastanud patsiendi immuunsüsteemi ja kui patsiendil ei ole tekkinud siiriku äratõukereaktsiooni (kui siiratud rakud ründavad organismi).
English: What measures are being taken to ensure the safe and effective use of Zalmoxis?
Estonian: Mis meetmed võetakse, et tagada Zalmoxise ohutu ja efektiivne kasutamine?
English: Although more data are needed to determine the size of the benefit, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zalmoxis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Kuigi ravimi kasulikkuse täpsustamiseks on vaja rohkem andmeid, otsustas inimravimite komitee, et Zalmoxise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: In this study, Zalmoxis was not compared with any other treatment.
Estonian: Uuringus ei võrreldud Zalmoxist ühegi muu ravimeetodiga.
English: The main measure of effectiveness was restoration of the immune system as measured by blood levels of T cells.
Estonian: Efektiivsuse põhinäitaja oli immuunsüsteemi taastumine, mida mõõdeti T-rakkude sisaldusega veres.
English: The safety profile of Zalmoxis is considered acceptable.
Estonian: Zalmoxise ohutusprofiili peetakse vastuvõetavaks.
English: The company will also collect data from all patients treated with Zalmoxis through a registry and will monitor their progress after treatment to study long-term safety and effectiveness of the medicine.
Estonian: Ettevõte peab ka kõigi Zalmoxisega ravitud patsientide registrit ning jälgib nende paranemist pärast ravi, et uurida ravimi pikaajalist ohutust ja efektiivsust.
English: Zalmoxis is prepared for use in a specific patient.
Estonian: Zalmoxis valmistatakse kasutamiseks konkreetsel patsiendil.
English: The most common side effect with Zalmoxis (which may affect more than 1 in 10 people) is acute graft-versus-host disease (where the condition develops within approximately 100 days of the transplant).
Estonian: Zalmoxise kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10-st) on äge siiriku äratõukereaktsioon (seisund tekib ligikaudu 100 päeva jooksul pärast siirdamist).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Zalmoxis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Zalmoxise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is Zalmoxis and what is it used for?
Estonian: Mis on Zalmoxis ja milleks seda kasutatakse?
English: The company that markets Zalmoxis will provide educational material for healthcare professionals with detailed information on the risks, including graft-versus-host disease, and how to use the medicine correctly.
Estonian: Zalmoxist turustav ettevõte annab tervishoiutöötajatele õppematerjalid, mis sisaldavad üksikasjalikku teavet riskide, sealhulgas siiriku äratõukereaktsiooni, ja ravimi õige kasutamise kohta.
English: This is a summary of the European public assessment report (EPAR) for Zalmoxis.
Estonian: See on ravimi Zalmoxis Euroopa avaliku hindamisaruande kokkuvõte.
English: The full EPAR for Zalmoxis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Zalmoxise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The number of patients who survived after one year was 51% for patients who received Zalmoxis compared with 34 to 40% for patients who did not receive Zalmoxis.
Estonian: Ühe aasta pärast oli elus 51% Zalmoxist kasutanud patsientidest, ja 34-40% patsientidest, kes ei kasutanud Zalmoxist.
English: Zalmoxis is given as an infusion (drip) into a vein lasting 20 to 60 minutes, every month for up to four months until the circulating T cells reach a certain level.
Estonian: Zalmoxist manustatakse 20-60 minutit kestva intravenoosse (veeni tilgutatava) infusioonina kord kuus kuni nelja kuu jooksul, kuni veres ringlevad T-rakud saavutavad teatud sisalduse.
English: All 10 patients recovered from graft-versus-host disease.
Estonian: Kõik kümme patsienti paranesid siiriku äratõukereaktsioonist.
English: It must also not be used in patients who have already developed graft-versus-host disease that requires treatment.
Estonian: Samuti ei tohi seda anda patsientidele, kellel on tekkinud ravi vajav siiriku äratõukereaktsioon.
English: 77% of the patients receiving Zalmoxis (23 out of 30) had their immune systems restored.
Estonian: 77%-l Zalmoxist saanud patsientidest (23 patsienti 30st) taastus immuunsüsteem.
English: These T cells are then genetically modified to include a ‘suicide gene'.
Estonian: Seejärel modifitseeritakse T-rakke nii, et need sisaldaksid „enesetapugeeni”.
English: However the T cells in Zalmoxis can sometimes attack the patient's body, causing graft-versus-host disease.
Estonian: Siiski võivad Zalmoxises sisalduvad T-rakud mõnikord patsiendi organismi rünnata, põhjustades siiriku äratõukereaktsiooni.
English: Why is Zalmoxis approved?
Estonian: Miks Zalmoxis heaks kiideti?
English: Other information about Zalmoxis
Estonian: Muu teave Zalmoxise kohta
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zalmoxis have also been included in the summary of product characteristics and the package leaflet.
Estonian: Zalmoxise ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ning patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Zalmoxis must not be used in patients whose immune system has been restored.
Estonian: Zalmoxist ei tohi anda patsientidele, kelle immuunsüsteem on juba taastunud.
English: Graftversus-host disease occurred in 10 patients who were then given ganciclovir or valganciclovir, either alone or in combination with other medicines.
Estonian: Siiriku äratõukereaktsioon tekkis kümnel patsiendil, kellele manustati gantsikloviiri või valgantsikloviiri kas üksi või koos teiste ravimitega.
English: Zalmoxis contains T cells (a type of white blood cell) that have been genetically modified1.
Estonian: Zalmoxis sisaldab T-rakke (teatud tüüpi vere valgelibled), mida on geneetiliselt modifitseeritud1.
English: The main risk is graft-versus-host disease, however this can be successfully treated with ganciclovir or valganciclovir, which kill the T cells in Zalmoxis.
Estonian: Peamine risk on siiriku äratõukereaktsioon, mida saab siiski edukalt ravida gantsikloviiri või valgantsikloviiriga, mis hävitavad Zalmoxises sisalduvad T-rakud.