FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common symptoms of PML are progressive weakness, speech and communication difficulties, vision changes, and sometimes changes in mood or behaviour.
Estonian: PML-i sagedaimad sümptomid on progresseeruv nõrkus, kõne- ja suhtlemishäired, nägemishäired ning mõnikord meeleolu või käitumise muutused.
English: • have tested positive for JC virus, and
Estonian: • on JC-viiruse suhtes positiivsed,
English: New recommendations have been issued which may help early detection of PML and improve patients' outcomes.
Estonian: Välja on antud uued soovitused, mis aitavad PML-i varakult tuvastada ja parandada patsientide prognoosi.
English: By attaching to the integrin, natalizumab stops the leucocytes from going from the blood into the brain, thereby reducing the inflammation and nerve damage caused by MS.
Estonian: Integriiniga seondudes peatab natalisumaab leukotsüütide liikumise verest peaajju, vähendades seega hulgiskleroosi põhjustatud põletikku ja närvikahjustust.
English: 2 PML risk estimates were derived using the life table method based on the pooled cohort of 21,696 patients who participated in the STRATIFY-2, TOP, TYGRIS, and STRATA clinical studies.
Estonian: PML-riski hinnangud arvutati elutabeli meetodil, mis põhines kliinilistes uuringutes STRATIFY-2, TOP, TYGRIS ja STRATA osalenud 21 696 patsiendi koondandmetel.
English: • More information about the risk of PML with Tysabri is included in the Patient Alert Card you have been given by your doctor.
Estonian: • Tysabriga kaasneva PML-i riski lisateave on patsiendikaardil, mille annab teile arst.
English: On 25 February 2016, EMA completed its review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab), and confirmed initial recommendations1 aimed at minimising this risk.
Estonian: Euroopa Ravimiamet (EMA) lõpetas 25. veebruaril 2016 hulgiskleroosi ravimi Tysabri (natalisumaab) teadaoleva progresseeruva multifokaalse leukoentsefalopaatia (PML) riski andmete läbivaatamise ja kinnitas esialgsed riski vähendamise soovitused1.
English: • Symptoms of PML may be similar to those of a multiple sclerosis attack, and include progressive weakness, speech and communication difficulties, vision problems, and sometimes changes in mood or behaviour.
Estonian: • PML-i sümptomid võivad sarnaneda hulgiskleroosi ägenemise sümptomitega, näiteks progresseeruv nõrkus, kõne- ja suhtlemishäired, nägemishäired ning mõnikord meeleolu või käitumise muutused.
English: Considering these factors, your doctor will be able to advise you about your risk of developing PML.
Estonian: Neid neid tegureid arvestades selgitab teie arst teile PML-i tekkeriski.
English: • PML should be considered in the differential diagnosis of any patient presenting with neurological symptoms and/or new brain lesions on MRI.
Estonian: • PML on diferentsiaaldiagnostiliselt oluline igal patsiendil, kellel esinevad neuroloogilised sümptomid ja/või uued ajukolded MRT-uuringul.
English: All patients taking Tysabri should undergo full MRI scans at least once a year, but on the basis of the new data EMA recommended that for patients at higher risk of PML more frequent MRI scans (e.g. every 3 to 6 months) performed using simplified protocols should be considered.
Estonian: Kõigile Tysabrit kasutavatele patsientidele tuleb vähemalt üks kord aastas teha MRTuuring, kuid uute andmete alusel soovitab EMA PML-i suurema riskiga patsientidele teha MRT-uuringuid sagedamini (nt iga 3-6 kuu järel), võimaluse korral lihtsustatud uuringuprotokollide järgi.
English: This protein is found on the surface of most leucocytes (the white cells in the blood that are involved in the inflammation process).
Estonian: α4β1-integriini leidub enamiku leukotsüütide pinnal (vere valgelibled, mis osalevad põletikuprotsessis).
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted its final opinion.
Estonian: Riskihindamiskomitee soovitused saadeti seejärel inimravimite komiteele, kes kinnitas need ja võttis vastu lõpliku arvamuse.
English: • After 2 years of treatment, patients should be informed again about the risk of PML with Tysabri.
Estonian: • Pärast 2-aastast ravi tuleb patsientidele uuesti selgitada Tysabriga kaasnevat PML-riski.
English: More detailed information on the risk stratification, diagnosis and treatment of PML will be included in the updated Physician Information and Management Guidelines for Tysabri.
Estonian: Riski stratifitseerimise, PML-i diagnostika ja ravi lisateave lisatakse Tysabri ravimiteabe jaotisesse „Teave arstile” ja ravisuunistesse.
English: • Before starting treatment with Tysabri, and then regularly during treatment, your doctor will do blood tests to measure the level of antibodies for JC virus and MRI scans to monitor your condition.
Estonian: • Enne Tysabri-ravi alustamist ja regulaarselt ravi ajal teeb arst teile JC-viiruse vastaste antikehade taseme määramiseks vereanalüüse ja teie seisundi jälgimiseks MRT-uuringuid.
English: It is used when the disease has failed to respond to treatment with a beta-interferon or glatiramer acetate (other types of medicines used in MS), or is severe and getting worse rapidly.
Estonian: Tysabrit kasutatakse, kui ravi beetainterferooni või glatirameeratsetaadiga (samuti hulgiskleroosi ravimid) on jäänud ravivastuseta või kui hulgiskleroos on raske ja süveneb kiiresti.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific part of a protein called ‘α4β1 integrin'.
Estonian: Tysabri toimeaine natalisumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära valgu α4β1integriini teatud osa ja seondub sellega.
English: • During treatment with Tysabri, patients should be monitored at regular intervals for signs and symptoms of new neurological dysfunction, and a full brain MRI should be performed at least once a year for the duration of treatment.
Estonian: • Tysabri-ravi ajal tuleb patsiente regulaarsete ajavahemike tagant jälgida uute neuroloogiliste häirete nähtude ja sümptomite suhtes ning ravi ajal teha vähemalt üks kord aastas peaaju MRTuuring.
English: • Progressive multifocal leukoencephalopathy (PML, a serious brain infection) is known to be an uncommon risk with the multiple sclerosis medicine Tysabri.
Estonian: • Progresseeruv multifokaalne leukoentsefalopaatia (PML, raske ajuinfektsioon) on hulgiskleroosi ravimiga Tysabri kaasnev teadaolev aeg-ajalt esinev risk.
English: • either have used an immunosuppressant before starting Tysabri, or have not used immunosuppressants and have a high JC virus antibody index.
Estonian: • on enne Tysabri-ravi algust kasutanud immunosupressante või kes ei ole kasutanud immunosupressante ja kelle JC-viiruse vastaste antikehade indeks on suur.
English: months *from Tysabri Physician Information and Management Guidelines
Estonian: * Tysabri ravimiteabe jaotisest „Teave arstile” ja ravisuunistest
English: • Anti-JC virus antibody testing should be done every 6 months in antibody-negative patients.
Estonian: • Kõigil JC-viiruse vastaste antikehade suhtes negatiivsetel patsientidel tuleb iga 6 kuu tagant teha JC-viiruse vastaste antikehade uuring.
English: In patients who tested negative for JC virus antibodies, the PML risk estimate remains unchanged at 0.1 per 1,000 patients.
Estonian: JC-viiruse vastaste antikehade suhtes negatiivsetel patsientidel on hinnanguline PML-risk muutumatu, 0,1 juhtu 1000 patsiendi kohta.
English: Prior use of immunosuppressants
Estonian: On varem kasutanud immunosupressante
English: • Patients and carers should be advised to continue to be vigilant about the risk of PML for up to 6 months following discontinuation of Tysabri.
Estonian: • Patsientidele ja nende hooldajatele tuleb soovitada pöörata PML-riskile tähelepanu 6 kuu jooksul pärast Tysabri-ravi lõppu.
English: • If PML is suspected, your doctor will stop treatment with Tysabri until PML can be ruled out.
Estonian: • Kui teil kahtlustatakse PML-i, katkestab teie arst Tysabri-ravi, kuni PML on välistatud.
English: • Your risk of PML depends on several factors, such as whether you have antibodies against JC virus in your blood (a sign that you have been exposed to the virus that causes PML) and what their level is, how long you have been treated with Tysabri, and whether or not you were treated with medicines that suppress your immune system before starting Tysabri.
Estonian: • PML-risk sõltub mitmest tegurist, näiteks JC-viiruse vastaste antikehade olemasolust veres (mis viitab kokkupuutele PML-i põhjustava viirusega) ja nende sisaldusest, Tysabri-ravi kestusest ja sellest, kas patsienti on enne Tysabri-ravi alustamist ravitud immunosupressantidega (immuunsüsteemi pärssivate ravimitega).
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Estonian: Kõigepealt vaatas teabe läbi inimravimite ohutusprobleemide hindamise eest vastutav ravimiohutuse riskihindamise komitee, kes koostas soovitused.
English: No prior use of immunosuppressants
Estonian: Ei ole varem kasutanud immunosupressante
English: • Before starting treatment, a baseline MRI should be available (usually within 3 months) as a reference, and a baseline anti-JCV antibody test should be performed to support PML risk stratification.
Estonian: • Enne ravi alustamist tuleb teha esialgne MRT-uuring (tavaliselt 3 kuu jooksul) ja esialgne JCviiruse vastaste antikehade uuring, et toetada PML-riski stratifitseerimist.
English: Known risk factors for the development of PML in patients treated with Tysabri are the presence of antibodies against JC virus, treatment with Tysabri for more than two years, and previous use of immunosuppressants.
Estonian: Tysabriga ravitavate patsientide PML-i tekkimise teadaolevad riskitegurid on JC-viiruse vastaste antikehade olemasolu, Tysabri-ravi kestus üle kahe aasta ja varasem immunosupressantide kasutamine.
English: More frequent MRI scans should be considered for patients at higher risk
Estonian: Suurema riskiga patsientidel tuleb teha MRT-uuringuid sagedamini
English: Asymptomatic cases of PML can be detected on MRI scans, and experts in the field of MRI and multiple sclerosis agree that simplified MRI protocols (which allow for shorter procedures, and also limit the burden for patients undergoing the scans) permit the identification of PML lesions.
Estonian: PML-i sümptomiteta juhte saab tuvastada MRTuuringuga ning MRT- ja hulgiskleroosi spetsialistid nõustuvad, et PML-i koldeid saab tuvastada lihtsustatud MRT-protokolle kasutades (lühemad protseduurid, vähem koormust uuritavatele patsientidele).
English: The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Estonian: Riskihindamiskomitee soovitused saadeti seejärel inimravimite komiteele, kes vastutab kõigi inimravimitega seotud probleemide eest ja kes võttis vastu EMA lõpliku arvamuse.
English: • Before starting treatment with Tysabri, patients and carers should be advised about the risk of PML.
Estonian: • Enne Tysabri-ravi algust tuleb selgitada patsientidele ja nende hooldajatele PML-riski.
English: Further stratification of PML risk by anti-JC virus antibody index interval for patients with no prior use of immunosuppressants were derived from combining the overall yearly risk with the antibody index distribution.
Estonian: PML-riski stratifitseeriti edasi JC-vastaste antikehade indeksi intervalli järgi patsientidel, kes ei olnud varem kasutanud immunosupressante, kombineerides üldist aastariski antikehaindeksi jaotusega.
English: In light of the new evidence, patients are considered at higher risk of developing PML if they:
Estonian: Nende uute andmete järgi peetakse PML-i tekkeriski suuremaks patsientidel, kes
English: These tests may be done more often if you are considered at higher risk for PML.
Estonian: Kui teil on suurem PML-risk, võidakse neid uuringuid teha sagedamini.
English: New data from large clinical studies also suggest that, in patients who have not been treated with immunosuppressants (medicines that reduce the activity of the immune system) before starting Tysabri, the blood level of antibodies against JC virus (‘antibody index') relates to the level of risk for PML.
Estonian: Suurte kliiniliste uuringute uued andmed viitavad ka, et patsientidel, keda enne Tysabri-ravi algust ei ole ravitud immunosupressantidega, on JC-viiruse vastaste antikehade sisaldus veres (antikehaindeks) seotud PML-riskiga.
English: The CHMP's opinion was then sent to the European Commission, which issued a legally-binding decision valid throughout the EU.
Estonian: Inimravimite komitee arvamus edastati Euroopa Komisjonile ja komisjon tegi kogu Euroopa Liidus kehtiva lõpliku otsuse.
English: Based on these data, updated risk estimates for PML2 in JC virus antibody-positive patients treated with Tysabri are available, as shown in Table 1 below:
Estonian: Nende andmete alusel on alljärgnevas tabelis 1 esitatud PML-riski2 uuendatud hinnangud JC-viiruse vastaste antikehade suhtes positiivsetel Tysabriga ravitavatel patsientidel:
English: Patients who have low index values and no history of prior immunosuppressant use should also be retested every 6 months once they reach the 2-year treatment point.
Estonian: Kui ravi on kestnud 2 aastat, tuleb iga 6 kuu tagant uuesti kontrollida ka patsiente, kelle indeksi väärtus on väike ja kes ei ole varem kasutanud immunosupressante.
English: The updated risk estimates above show that the risk of developing PML is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with Tysabri for longer than 2 years.
Estonian: Need uuendatud riskihinnangud tõendavad, et PML-i tekkerisk on antikehaindeksiga kuni 0,9 patsientidel väike ja varem hinnatust väiksem.
English: Tysabri is a medicine used to treat adults with highly active multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Estonian: Hulgiskleroos on närvihaigus, mille korral põletik hävitab närvirakke ümbritseva kaitsekesta.
English: • If PML is suspected, the MRI protocol should be extended to include contrast-enhanced T1weighted imaging and testing of CSF for the presence of JC virus DNA using ultrasensitive PCR should be considered.
Estonian: • PML-kahtluse korral tuleb MRT-protokolli laiendada, et lisada uuringusse kontrastainega T1kaalutud MRT-uuring ja kontrollida ülitundlikku PCR-iiga võimaluse korral, kas seljaajuvedelikus esineb JC-viiruse DNA-d.
English: Table 1: PML risk estimates per 1,000 patients in anti-JC virus antibody positive patients* Duration of Tysabri use
Estonian: Hinnanguline PML-risk JC-viiruse vastaste antikehade suhtes positiivsel 1000 patsiendil*
English: If lesions suggestive of PML are discovered, the MRI protocol should be extended to include ‘contrast-enhanced T1-weighted MRI', and testing the spinal fluid for the presence of JC virus should be considered.
Estonian: Kui leitakse PML-le viitav kolle, tuleb MRT-protokolli laiendada, lisades uuringusse kontrastainega T1-kaalutud MRT-uuringu ja võimaluse korral kontrollida, kas seljaajuvedelikus esineb JC-viirust.
English: Recent studies suggest that early detection and treatment of PML when the disease is asymptomatic (is still in the initial stages and shows no symptoms) may improve patients' outcomes.
Estonian: Hiljutiste uuringute andmeil võib PML-i varane tuvastamine ja ravi haiguse varajastes sümptomiteta staadiumides patsientide prognoosi parandada.
English: Pooled data from large clinical studies suggest that, in patients with no prior immunosuppressant use, the level of anti-JC virus antibody response (index) relates to the level of risk for PML.
Estonian: Suurte kliiniliste uuringute koondandmete järgi on patsientidel, kes ei ole varem kasutanud immunosupressante, JC-viiruse vastaste antikehade reaktsioon (antikehaindeks) seotud PML-riskiga.
English: Cases of asymptomatic PML based on MRI and positive JC virus DNA in the CSF have been reported.
Estonian: Teatatud on sümptomiteta PML-juhtudest, mis diagnoositi MRT-uuringu ja seljaajuvedelikus leidunud JC-viiruse DNA järgi.
English: EMA confirms recommendations to minimise risk of brain infection PML with Tysabri
Estonian: Euroopa Ravimiamet kinnitab Tysabriga kaasneva teatud ajuinfektsiooni (progresseeruva multifokaalse leukoentsefalopaatia) riski vähendamise soovitused
English: Index 0.9 to
Estonian: Indeks kuni
English: • For patients at higher risk of PML, more frequent MRIs (e.g. every 3-6 months) using an abbreviated protocol (e.g.
Estonian: • Suurema PML-riskiga patsientidel tuleb võimaluse korral teha MRT-uuringuid sagedamini (nt iga 36 kuu tagant) ja lühendatud protokolli alusel (nt FLAIR, T2-kaalutud ja DW-MRT), sest PML-i varane diagnoosimine sümptomiteta patsientidel on seotud PML-i parema prognoosiga.
English: This is expected to help to prevent organ damage.
Estonian: Sel viisil loodetakse ennetada elundi kahjustumist.
English: International non-proprietary name (INN): eprodisate sodium
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): naatriumeprodisaat
English: What is Kiacta?
Estonian: Mis on Kiacta?
English: The main measure of effectiveness was the number of patients whose kidney function got significantly worse or who died over two years of treatment.
Estonian: Ravimi tõhususe põhinäitajaks oli patsientide arv, kelle neerude talitlus märkimisväärselt halvenes või kes pärast kaheaastast ravi surid.
English: The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Estonian: Ettevõte oli taotlenud negatiivse arvamuse ülevaatamist, ning see ei olnud taotluse tagasivõtmise ajal veel lõppenud.
English: Ref. EMEA/136938/2008
Estonian: London, 13. märts 2008 Viitedokument: EMEA/180132/2008
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Estonian: Ettevõtte kiri, milles ta teavitab Euroopa Ravimiametit oma taotluse tagasivõtmisest, on avaldatud siin.
English: Kiacta was designated an orphan medicinal product on 31 July 2001.
Estonian: Kiacta nimetati harvikravimiks 31. juulil 2001.
English: On 13 March 2008, Neurochem Luxco II SARL officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kiacta for the treatment of amyloid A amyloidosis.
Estonian: 13. märtsil 2008 teatas ettevõte Neurochem Luxco II SARL ametlikult inimravimikomiteele, et soovib tagasi võtta A-amüloidi tekitatava amüloidoosi raviks ette nähtud ravimi Kiacta müügiloa taotluse.
English: What are the consequences of the withdrawal for patients in clinical trials with Kiacta?
Estonian: Millised on taotluse tagasivõtmise tagajärjed praegu Kiacta kliinilistes uuringutes osalevatele patsientidele?
English: It was to be available as capsules.
Estonian: See oli ette nähtud kapslitena turustamiseks.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Kiacta had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Estonian: Seepärast oli inimravimikomitee tagasivõtmise ajal seisukohal, et Kiacta kasulikkust ei olnud piisavalt tõendatud ning et see ei olnud suurem väljaselgitatud riskidest.
English: The effectiveness of Kiacta was studied in one main study involving 183 patients with AA amyloidosis, in which Kiacta was compared with placebo (a dummy treatment).
Estonian: Kiacta tõhusust uuriti ühes põhiuuringus, milles osales 183 patsienti, kellel oli AA-amüloidoos; uuringus võrreldi Kiactat patseeboga (näiv ravim).
English: The company informed the CHMP that the ongoing clinical trial with Kiacta is being stopped, so that it can carry out a second study to compare Kiacta with placebo.
Estonian: Ettevõte teatas inimravimikomiteele, et Kiacta kliinilised uuringud on peatatud, et ta saaks läbi viia teise uuringu, milles võrreldakse Kiactat platseeboga.
English: Kiacta is a medicine containing the active substance eprodisate disodium.
Estonian: Kiacta on ravim, mis sisaldab toimeainena naatriumeprodisaati.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Kiacta for the treatment of AA amyloidosis.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimikomitee esitatud küsimustele, oli komitee andnud taotluse tagasivõtmise ajal negatiivse arvamuse ega soovitanud anda Kiactale AAamüloidoosi ravis kasutamiseks müügiluba.
English: In addition, following an inspection of the site where the data from the study were analysed, the CHMP had concerns over the reliability of the study's findings because of the way the analysis was carried out.
Estonian: Pärast uuringu andmete analüüsikoha kontrollimist tekitas analüüsi viis inimravimikomiteel ka kahtlusi uuringu tulemuste usaldusväärsuse suhtes.
English: The most serious symptoms of the disease are caused by AA deposits building up in the kidneys and damaging them.
Estonian: Haiguse kõige raskemaid sümptomeid tekitavad neerudes moodustuvad ja neid kahjustavad A-amüloidi ladestused.
English: What were the main concerns of the CHMP?
Estonian: Mis oli inimravimikomitee ettevaatlikkuse peamiseks põhjuseks?
English: The active substance in Kiacta, eprodisate disodium, is expected to work by interfering with the formation of fibrils of AA, preventing the deposits from building up in the organs.
Estonian: Kiacta toimeaine naatriumeprodisaat eeldatavasti sekkub A-amüloidi fibriilide moodustumisse, takistades nende ladestumist elundites.
English: How is Kiacta expected to work?
Estonian: Mis on Kiacta eeldatav toime?
English: Although there was a suggestion that Kiacta may be active, the Committee concluded that another study would be needed to demonstrate the medicine's effectiveness.
Estonian: Kuigi Kiacta näis toimivat, arvas komitee, et ravimi tõhusust tuleks tõendada veel ühe uuringu alusel.
English: This is a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.
Estonian: A-amüloidi tekitatav amüloidoos on haruldane eluohtlik haigus, mis esineb patsientidel, kellel on pikaajaline, enamasti reumatoidartriidist põhjustatud põletik.
English: The effects of Kiacta were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Kiacta toimet muude katsetega.
English: The CHMP was concerned that the effectiveness of Kiacta in treating AA amyloidosis had not been demonstrated sufficiently in the single main study.
Estonian: Inimravimikomitee arvates ei tõendanud ainus põhiuuring Kiacta tõhusust AA-amüloidoosi raviks piisaval määral.
English: What was Kiacta expected to be used for?
Estonian: Milleks kavatseti Kiactat kasutada?
English: Amyloid A amyloidosis is caused by the build-up of insoluble ‘fibrils' (fine threads) of a protein called ‘amyloid A' (AA) in the organs of the body.
Estonian: AA-amüloidoosi põhjustab valk A-amüloidi (amyloid associated, AA) lahustamatute fibriilide (peente kiudude) moodustumine organismi elundites.
English: Kiacta was expected to be used to treat amyloid A amyloidosis.
Estonian: Kiacta oli ette nähtud A-amüloidi tekitatava amüloidoosi (AA-amüloidoos) raviks.
English: AA is produced in the body from a protein called ‘serum amyloid A', which is released by liver cells in response to inflammation.
Estonian: A-amüloidi toodab organismis seerumamüloid-A-eellasvalk, mida põletiku korral sünteesitakse maksas.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for KIACTA
Estonian: TEAVE MÜÜGILOA TAOTLUSE TAGASIVÕTMISE KOHTA
English: Pilisborosjenő 2097 Hungary
Estonian: Pilisborosjenő 2097 Ungari