FrancophonIA/ELRC3.0 huggingface dataset:
English: Both mycosis fungoides and Sezary syndrome belong to a group of rare cancers (cutaneous T-cell lymphomas), and Poteligeo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 October 2016.
Estonian: Fungoidmükoos ja Sezary sündroom kuuluvad harvaesineva vähivormi, naha T-rakuliste lümfoomide rühma ja Poteligeo nimetati 14. oktoobril 2016 harvikravimiks.
English: How does Poteligeo work?
Estonian: Kuidas Poteligeo toimib?
English: The medicine is given as an infusion (drip) into a vein lasting at least 1 hour.
Estonian: Poteligeot manustatakse vähemalt 1 tund kestva veeniinfusioonina.
English: Poteligeo can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the treatment of cancer and in a place where equipment for resuscitation is available in case of rare and severe allergic reaction to the medicine.
Estonian: Ravi peab toimuma vähiravis kogenud arsti järelevalve all tingimustes, kus on olemas elustamisseadmed harvaesineva ja raske allergilise ravimireaktsiooni raviks.
English: What are the risks associated with Poteligeo?
Estonian: Mis riskid Poteligeoga kaasnevad?
English: How is Poteligeo used?
Estonian: Kuidas Poteligeot kasutatakse?
English: The active substance in Poteligeo, mogamulizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to a receptor (target) called CCR4.
Estonian: Poteligeo toimeaine mogamulisumaab on monoklonaalne antikeha (teatud valk), mis seondub sihtmärgi CCR4 retseptoriga.
English: What benefits of Poteligeo have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Poteligeo kasulikkus?
English: An overview of Poteligeo and why it is authorised in the EU
Estonian: Ülevaade ravimist Poteligeo ja ELis müügiloa väljastamise põhjendus
English: The doctor may interrupt or stop treatment, or reduce the dose, if the patient develops certain serious side effects.
Estonian: Kui patsiendil tekivad teatud rasked kõrvalnähud, võib arst ravi katkestada või lõpetada või annust vähendada.
English: Poteligeo is effective at prolonging the time patients with mycosis fungoides or Sezary syndrome live without their disease getting worse.
Estonian: Poteligeo on efektiivne fungoidmükoosi või Sezary sündroomiga patsientide progresseerumiseta elumuse pikendamisel.
English: To reduce this risk, patients may be given other medicines such as an antipyretic (medicine that reduces fever) and an antihistamine (for treating allergic reactions) before or during treatment with Poteligeo.
Estonian: Enne ravi Poteligeoga ja selle ajal võib anda patsiendile kõrvalnähtude riski vähendamiseks muid ravimeid, näiteks palavikuvastast ja allergiavastast ravimit.
English: CCR4 is found on the surface of white blood cells, including the cancerous cells in mycosis fungoides or Sezary syndrome.
Estonian: CCR4 esineb leukotsüütide, sealhulgas fungoidmükoosi ja Sezary sündroomiga patsientide vähirakkude pinnal.
English: Poteligeo contains the active substance mogamulizumab.
Estonian: Poteligeo sisaldab toimeainena mogamulisumaabi.
English: Why is Poteligeo authorised in the EU?
Estonian: Poteligeo Euroopa Liidus heakskiitmise põhjused
English: This may take up to 5 weeks.
Estonian: Selleks võib kuluda kuni 5 nädalat.
English: This summary was last updated in 03-2017.
Estonian: Kokkuvõtte viimane uuendus: 03-2017.
English: Pergoveris must not be used in women who have:
Estonian: Pergoverist ei tohi kasutada naistel, kellel on:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pergoveris on 25 June 2007.
Estonian: Euroopa Komisjon andis Pergoverise müügiloa, mis kehtib kogu Euroopa Liidus, 25. juunil 2007.
English: What measures are being taken to ensure the safe and effective use of Pergoveris?
Estonian: Mis meetmed võetakse, et tagada Pergoverise ohutu ja efektiivne kasutamine?
English: The full EPAR for Pergoveris can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Pergoverise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Pergoveris
Estonian: Muu teave Pergoverise kohta
English: • cancer of the ovary, womb or breast.
Estonian: • munasarja-, emaka- või rinnavähk.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Pergoveris's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Pergoverise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: The first injection must be given under direct supervision of a doctor who has experience in the treatment of fertility problems, but the patient can inject herself if she wants to, provided she has been properly trained and has access to expert advice.
Estonian: Esimene süst tuleb teha viljakusravis kogenud arsti järelevalve all, kuid patsient tohib end soovi korral süstida ka ise, kui ta on saanud asjakohase ettevalmistuse ja tal on juurdepääs spetsialisti nõuannetele.
English: This may help these women to become pregnant.
Estonian: See võib aidata rasestuda.
English: If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
Estonian: Vajaduse korral võib alfafollitropiini annuse suurendamiseks lisada seda eraldi ravimina, suurendades annust 7-14 päeva tagant.
English: The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection).
Estonian: Pergoverise kohta teatatud kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on peavalu, munasarja tsüstid ja süstekoha reaktsioonid (nt süstekoha valu, sügelus, punetus, verevalum, turse või ärritus).
English: What is Pergoveris and what is it used for?
Estonian: Mis on Pergoveris ja milleks seda kasutatakse?
English: Therefore, the company presented information from studies carried out during the development of Luveris to support the use of Pergoveris.
Estonian: Seepärast esitas ettevõte Pergoverise kasutamise toetamiseks Luverise väljatöötamisel korraldatud uuringutega saadud teavet.
English: • enlarged ovaries or a cyst on the ovary that is not due to polycystic ovarian disease and is of unknown origin,
Estonian: • munasarjade suurenemine või munasarjatsüst, mida ei ole põhjustanud munasarjade polütsüstiline haigus ja mille päritolu ei ole teada;
English: Why is Pergoveris approved?
Estonian: Miks Pergoveris heaks kiideti?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pergoveris have been included in the summary of product characteristics and the package leaflet.
Estonian: Pergoverise ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Pergoveris is injected under the skin once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels.
Estonian: Pergoverist süstitakse naha alla üks kord ööpäevas, kuni patsiendil areneb sobiv folliikul, mida hinnatakse folliikuli suuruse mõõtmisega ultraheliuuringul ja vere östrogeenisisalduse mõõtmisega.
English: This is a summary of the European public assessment report (EPAR) for Pergoveris.
Estonian: See on ravimi Pergoveris Euroopa avaliku hindamisaruande kokkuvõte.
English: Pergoveris must not be used when a benefit cannot be obtained, such as in women with primary ovarian failure (when the ovaries stop working before the menopause).
Estonian: Pergoverist ei tohi kasutada, kui see ei ole kasulik, nt munasarja primaarse puudulikkusega naistel (kui munasarjade talitlus lõpeb enne menopausi).
English: The company also carried out bioequivalence studies to establish whether the combined injection produced the same levels of the active substances in the body as the two medicines given separately.
Estonian: Ettevõte tegi täiendavad bioekvivalentsusuuringud, et kontrollida, kas ravimite koos süstimisel tekib organismis toimeaine sama sisaldus kui kummagi ravimi kasutamisel eraldi.
English: It is not intended to provide practical advice on how to use Pergoveris.
Estonian: Hindamisaruandes ei anta Pergoverise kasutamise praktilisi nõuandeid.
English: • bleeding from the genital region whose cause is unknown,
Estonian: • tundmatu põhjusega verejooks suguelundite piirkonnas;
English: What are the risks associated with Pergoveris?
Estonian: Mis riskid Pergoverisega kaasnevad?
English: Using less than the recommended starting dose may not be sufficient to stimulate development of a follicle.
Estonian: Ööpäevane annus alla soovitatud annuse võib olla folliikuli arengu stimuleerimiseks liiga väike.
English: Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems.
Estonian: Ravi võib tekitada munasarjade ülestimuleerimist (munasarja hüperstimulatsiooni sündroom), millest võivad tekkida rasked terviseprobleemid.
English: The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient's response.
Estonian: Soovitatav algannus on alfafollitropiini 150 IU ja alfalutropiini 75 IU üks kord ööpäevas, kohandatud patsiendi ravivastusega.
English: For more information about treatment with Pergoveris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Pergoverisega toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For practical information about using Pergoveris, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Pergoverise kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: EPAR summary for the public follitropin alfa / lutropin alfa
Estonian: Kokkuvõte üldsusele alfafollitropiin/alfalutropiin
English: For further information see the package leaflet.
Estonian: Üksikasjalik teave on pakendi infolehel.
English: For the full list of all side effects and restrictions with Pergoveris, see the package leaflet.
Estonian: Pergoverise kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS.
Estonian: Trombemboolia (veresoonte ummistumine trombidega) esineb väga harva ja on tavaliselt seotud munasarja raske hüperstimulatsiooni sündroomiga.
English: How is Pergoveris used?
Estonian: Kuidas Pergoverist kasutatakse?
English: By replacing the missing hormones, Pergoveris allows women with FSH and LH deficiency to develop a follicle, which will release an egg after an injection of the hormone human chorionic gonadotrophin (hCG).
Estonian: Pergoveris asendab FSH- ja LH-vaegusega naistel puuduvad hormoonid, et areneks folliikul, millest vabaneb pärast inim-kooriongonadotropiini (hCG) hormoonisüsti munarakk.
English: These studies confirmed that Pergoveris produced similar blood levels of follitropin alfa and lutropin alfa as when the two medicines are given separately.
Estonian: Uuringud kinnitasid, et Pergoveris tekitas veres alfafollitropiini ja alfalutropiini sarnase sisalduse nagu kummagi ravimi manustamisel eraldi.
English: Both active substances have already been authorised in the European Union (EU), follitropin alfa as GONAL-f and lutropin alfa as Luveris.
Estonian: Mõlemal toimeainel juba on Euroopa Liidus müügiluba: alfafollitropiinil ravimina GONAL-f ja alfalutropiinil ravimina Luveris.
English: Pergoveris is for adult women who have low levels of two hormones that stimulate the ovariesfollicle-stimulating hormone (FSH) and luteinising hormone (LH).
Estonian: Pergoveris on näidustatud täiskasvanud naistele, kellel on kahe munasarju stimuleeriva hormoonifolliikuleid stimuleeriva hormooni (FSH) ja luteiniseeriva hormooni (LH) - sisaldus väike.
English: In these studies, the combination of follitropin alfa and lutropin alfa at the same doses as in Pergoveris produced active follicles.
Estonian: Neis uuringutes tekitasid koos kasutatud alfafollitropiin ja alfalutropiin, samades annustes kui Pergoverises, aktiivseid folliikuleid.
English: In the body, FSH stimulates the production of eggs, and LH stimulates their release.
Estonian: Follitropiin stimuleerib munarakkude arengut ja lutropiin stimuleerib nende vabanemist.
English: What benefits of Pergoveris have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Pergoverise kasulikkus?
English: It must also not be used in women who have malformations of the sexual organs or fibroid tumours of the womb that would stop them from becoming pregnant.
Estonian: Pergoverist ei tohi kasutada ka naised, kellel on suguelundite väärareng või emaka leiomüoomid (teatud healoomulised kasvajad), mille tõttu nad ei rasestu.
English: Pergoveris is available as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection.
Estonian: Pergoverist turustatakse süstelahusena eeltäidetud pensüstlas või süstelahuse pulbri ja lahustina.
English: The medicine contains the active substances follitropin alfa and lutropin alfa.
Estonian: Ravim sisaldab toimeainetena alfafollitropiini ja alfalutropiini.
English: The active substances in Pergoveris, follitropin alfa and lutropin alfa, are copies of the natural hormones FSH and LH.
Estonian: Pergoverises toimeainetena sisalduvad alfafollitropiin ja alfalutropiin on looduslike hormoonide follitropiini (FSH) ja lutropiini (LH) tehisteisendid.
English: Mild or moderate OHSS is common, while severe OHSS is uncommon.
Estonian: Munasarja hüperstimulatsiooni sündroomi kerge või mõõdukas vorm on sage ja raske vorm esineb aeg-ajalt.
English: • tumours of the hypothalamus or pituitary gland,
Estonian: • hüpotalamuse või hüpofüüsi (ajuripatsi) kasvaja;
English: How does Pergoveris work?
Estonian: Kuidas Pergoveris toimib?
English: Pergoveris is a fertility medicine used in women to stimulate the development of follicles, the structures inside the ovaries that contain an egg.
Estonian: Pergoveris on viljakusravim, mida kasutatakse naistel, et stimuleerida folliikulite arengut.
English: The medicine can only be obtained with a prescription.
Estonian: Pergoveris on retseptiravim.
English: Ref.: EMEA/644240/2009 EMEA/H/C/396
Estonian: Viide: EMEA/644240/2009 EMEA/H/C/396
English: After five years, the marketing authorisation was renewed for a further five years.
Estonian: Viis aastat hiljem pikendati müügiluba veel viieks aastaks.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Estonian: Euroopa Ravimiamet vaatab kõik võimalikud uued andmed igal aastal läbi ja vajaduse korral uuendab käesolevat kokkuvõtet.
English: This means that it has not been possible to obtain complete information about Xigris.
Estonian: See tähendab, et Xigrise kohta ei ole olnud võimalik hankida täielikku teavet.
English: All the studies looked at the number of patients who had died after 28 days.
Estonian: Kõikides uuringutes registreeriti 28 päeva jooksul surnud patsientide arv.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xigris to Eli Lilly Nederland B.V. on 22 August 2002.
Estonian: Euroopa Komisjon andis Xigrise müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Eli Lilly Nederland B.V.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Xigris's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Xigrise kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: Doc.
Estonian: Xigris
English: The recommended dose of Xigris is 24 micrograms per kilogram body weight per hour, given as a continuous infusion for 96 hours.
Estonian: Soovitatav Xigrise annus on 24 mikrogrammi kehamassi kilogrammi kohta tunnis, mida tuleb manustada pideva infusioonina 96 tunni jooksul.
English: Sepsis is a condition when bacteria get into the bloodstream and produce harmful substances (toxins).
Estonian: Sepsis on seisund, kui bakterid satuvad vereringesse ja tekitavad kahjulikke aineid (toksiine).
English: As with other anticoagulants, the most common side effect with Xigris is bleeding.
Estonian: Nagu muudegi antikoagulantide korral, on Xigrise kõige tavalisem kõrvalnäht veritsus.
English: The toxins cause the patient's organs to fail, such as the heart, lungs and kidneys.
Estonian: Toksiinid põhjustavad patsiendi elundite (süda, kopsud, neerud jt) puudulikkust.
English: The active substance in Xigris, drotrecogin alfa (activated), is very similar to a natural anticoagulant found in the body called activated protein C. Drotrecogin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce drotrecogin alfa.
Estonian: Xigrise toimeaine aktiveeritud alfadrotrekogiin on väga sarnane organismis sisalduvale looduslikule antikoagulandile aktiveeritud proteiinile C. Alfadrotrekogiini valmistatakse rekombinant-DNA-tehnika abil: seda toodab rakk, millele on lisatud alfadrotrekogiini teket võimaldav geen (DNA).
English: Xigris has been studied in three studies in severe sepsis:
Estonian: Xigrist uuriti kolmes raske sepsise uuringus:
English: • in the ADDRESS study, Xigris was compared with placebo in almost 3,000 patients who were at a lower risk of death than in the first two studies.
Estonian: • uuringus ADDRESS võrreldi Xigrist platseeboga ligi 3000 patsiendil, kelle surmarisk oli väiksem kui esimeses kahes uuringus.
English: What is Xigris?
Estonian: Mis on Xigris?
English: What information is still awaited for Xigris?
Estonian: Mis teavet Xigrise kohta veel oodatakse?
English: In the body, drotrecogin alfa limits how much thrombin (one of the factors involved in blood clotting) is produced, and also reduces the inflammation caused by the infection.
Estonian: Alfadrotrekogiin piirab trombiini (üks vere hüübimisteguritest) tekkimist organismis ja samuti vähendab infektsioonist põhjustatud põletikku.
English: For the full list of restrictions, see the Package Leaflet.
Estonian: Piirangute täieliku loetelu leiate pakendi infolehelt.
English: Xigris is an anticoagulant, which means that it stops the blood coagulating (clotting).
Estonian: Xigris on antikoagulant, mis takistab vere koagulatsiooni (hüübimist).
English: • in the ENHANCE study, over 2,000 patients received Xigris;
Estonian: • uuringus ENHANCE manustati Xigrist üle 2000 patsiendile;
English: The company that makes Xigris will conduct an additional study looking at the safety and effectiveness of Xigris in patients with severe sepsis.
Estonian: Xigrise tootja teeb lisauuringu, milles vaatleb Xigrise ohutust ja efektiivsust raske sepsisega patsientidel.
English: Why has Xigris been approved?
Estonian: Miks Xigris heaks kiideti?
English: It must not be used in patients below 18 years of age, in patients who have long-term liver disease, a brain tumour or pressure on the brain, in patients also receiving high-dose heparin (another medicine used to prevent blood clots) or in patients who currently have internal bleeding or are at risk of bleeding.
Estonian: Xigrist ei tohi kasutada patsientidel, kes on alla 18 aasta vanad, kellel on krooniline maksahaigus, ajukasvaja või suurenenud koljusisene rõhk, kes saavad suures annuses hepariini (samuti antikoagulant) või kellel on seesmine verejooks või verejooksu risk.
English: Xigris should be used mainly when it can be started within 24 hours of the organ failure.
Estonian: Xigrist tuleb kasutada peamiselt siis, kui ravi saab alustada 24 tunni jooksul alates elundi puudulikkuse tekkest.
English: Excessive blood clotting is a problem during severe sepsis, because blood clots can block the blood supply to important parts of the body such as the kidneys and lungs.
Estonian: Raske sepsise korral on probleemiks vere liigne hüübimine, kui trombid (soonesisesed verehüübed) võivad takistada oluliste elundite, näiteks neerude ja kopsude verevarustust.
English: Xigris has been authorised under ‘Exceptional Circumstances'.
Estonian: Xigris on heaks kiidetud erandkorras.
English: • in the PROWESS study, Xigris was compared with placebo (dummy treatment) in 1,690 patients;
Estonian: • uuringus PROWESS võrreldi 1690 patsiendil Xigrist platseeeboga (näiv ravim);
English: Xigris drotrecogin alfa (activated) EPAR summary for the public
Estonian: Alfadrotrekogiin (aktiveeritud) Kokkuvõte üldsusele
English: The effect of Xigris was more marked when it was given within 24 hours of the start of organ failure, and in patients who had more than one organ failing.
Estonian: Xigrise mõju oli suurem, kui Xigrist manustati 24 tunni jooksul alates elundi puudulikkuse algusest ja kui patsiendil oli mitme elundi puudulikkus.
English: Xigris should be started within 48 hours, and preferably within 24 hours, after the start of organ failure.
Estonian: Xigrise manustamist tuleb alustada 48 tunni jooksul, soovitatavalt 24 tunni jooksul pärast elundipuudulikkuse algust.
English: Other information about Xigris:
Estonian: Muu teave Xigrise kohta
English: Fewer patients treated with Xigris had died at 28 days than patients treated with placebo.
Estonian: 28 päeva järel oli Xigrise-rühma patsiente surnud vähem kui platseeborühma patsiente.
English: Xigris is used when the patient has two or more organs failing, in addition to best standard care such as antibiotics, medicines to support the organs and treatment in a specialised unit.
Estonian: Xigrist kasutatakse lisaks parimale tavaravile (antibiootikumid, elundeid toetavad ravimid, ravi eriosakonnas jms), kui patsiendil on välja kujunenud kahe või enama elundi puudulikkus.
English: Xigris is a powder that is made up into a solution for infusion (drip into a vein).
Estonian: Xigris on pulber, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: It is intended for short-term use.
Estonian: Xigris on ette nähtud lühiajaliseks kasutamiseks.
English: For the full list of all side effects reported with Xigris, see the Package Leaflet.
Estonian: Xigrise kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: Giving Xigris using an infusion pump is the recommended way to ensure that infusion rates are well controlled.
Estonian: Xigrise manustamiseks soovitatakse kasutada infusioonipumpa, et tagada infusiooni kiiruse täpne reguleeritavus.
English: Xigris should not be used in people who may be hypersensitive (allergic) to drotrecogin alfa (activated), any of the other ingredients or bovine thrombin (a cow protein).
Estonian: Xigrist ei tohi kasutada patsiendid, kes võivad olla aktiveeritud alfadrotrekogiini, selle ravimi mis tahes muu koostisaine või veise trombiini (veise teatud verevalk) suhtes ülitundlikud (allergilised).
English: What is the risk associated with Xigris?
Estonian: Mis riskid kaasnevad Xigrisega?
English: Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis.
Estonian: Xigrist tohib kasutada üksnes kogenud arst asutuses, mis on spetsialiseerunud raske sepsisega patsientide raviks.
English: Xigris is used in adult patients with severe sepsis.
Estonian: Xigrist kasutatakse raske sepsisega täiskasvanud patsientide ravimiseks.
English: How does Xigris work?
Estonian: Kuidas Xigris toimib?
English: The full EPAR for Xigris is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Xigrise kohta leiate siit.