FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Neuraceq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Neuraceqi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: These data were further supported by the results from additional patients analysed after completion of the study.
Estonian: Neid andmeid toetasid ka lisapatsientide tulemused, mida hinnati pärast uuringu lõppu.
English: The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence that early diagnosis following PET scans with Neuraceq and early management of treatment will improve patient outcomes.
Estonian: Inimravimite komitee märkis siiski, et Alzheimeri tõve praegu olemasolevate ravimeetodite piiratud toimete tõttu puuduvad kindlad tõendid, et varane diagnoos pärast PET-uuringuid Neuraceqiga ja ravi varane algus parandavad patsientide lõpptulemusi.
English: When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity of 77.4% and a specificity of 94.2%.
Estonian: Lahangutulemuste võrdlemisel PET-uuringutega selgus, et uuringute tundlikkus oli 77,4% ja spetsiifilisus 94,2%.
English: There is however a risk of false positive results, and therefore Neuraceq should not be used as the sole diagnostic method for dementia, but in conjunction with clinical evaluation.
Estonian: Valepositiivsete tulemuste riski tõttu ei tohi aga Neuraceqi kasutada dementsuse ainukese diagnostilise meetodina, vaid seda tuleb kasutada koos kliinilise hindamisega.
English: Doctors will therefore need to use the scans together with clinical evaluation.
Estonian: Seetõttu peavad arstid kasutama PET-kujutisi koos kliinilise hindamisega.
English: β-amyloid plaques are deposits sometimes present in the brain of people with memory problems caused by dementia (such as Alzheimer's disease, Lewy-body dementia and Parkinson's disease dementia) and also in the brain of some elderly people with no symptoms.
Estonian: Beeta-amüloidnaastud on ladestused, mis esinevad mõnikord dementsuse (Alzheimeri tõbi, Lewy kehakeste dementsus ja Parkinsoni tõve dementsus) põhjustatud mäluprobleemidega inimeste ajus ja samuti mõne sümptomiteta eaka inimese ajus.
English: This is a summary of the European public assessment report (EPAR) for Neuraceq.
Estonian: See on ravimi Neuraceq Euroopa avaliku hindamisaruande kokkuvõte.
English: This is regarded as a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia.
Estonian: See parandab oluliselt selliste mäluprobleemidega patsientide diagnoosimist, keda hinnatakse seoses Alzheimeri tõve ja teiste dementsuse tüüpidega.
English: Patients should discuss the results of their PET scan with their doctor.
Estonian: Patsiendid peavad PET-uuringu tulemusi arutama oma arstiga.
English: Neuraceq delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.
Estonian: Neuraceqi kiirituse kogus on väga väike minimaalse vähi- või mis tahes pärilike kõrvalekallete riskiga.
English: Neuraceq is a solution for injection that contains the active substance florbetaben (18F); it is for diagnostic use only.
Estonian: Neuraceq on süstelahus, mis sisaldab toimeainet florbetabeeni (18F) ja on ette nähtud ainult diagnostiliseks kasutamiseks.
English: What is Neuraceq and what is it used for?
Estonian: Mis on Neuraceq ja milleks seda kasutatakse?
English: The medicine is given by injection into a vein about 90 minutes before obtaining an image from a PET scan.
Estonian: Ravimit manustatakse veenisüstina umbes 90 minutit enne PET-kujutise tegemist.
English: The type of scan used with Neuraceq is called positronemission tomography (PET).
Estonian: Uuringut Neuraceqiga nimetatakse positronemissioontomograafiaks (PET).
English: In addition, the usefulness of Neuraceq in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Estonian: Lisaks ei ole tuvastatud Neuraceqi kasulikkust mäluprobleemidega patsientide Alzheimeri tõve arengu prognoosimisel ja patsientide ravivastuse jälgimisel.
English: The most common side effects with Neuraceq (which may affect up to 1 in 10 people) are pain, irritation and reddening of the skin at the site of injection.
Estonian: Neuraceqi kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on süstekoha valulikkus, ärritus ja nahapunetus.
English: It is not intended to provide practical advice on how to use Neuraceq.
Estonian: Hindamisaruandes ei anta Neuraceqi kasutamise praktilisi nõuandeid.
English: However, a positive scan on its own is not sufficient to make a diagnosis in patients with memory problems, as plaques may be seen with several types of dementia and also in some elderly people with no symptoms.
Estonian: Siiski ei piisa positiivsest tulemusest mäluhäiretega patsiendi diagnoosimiseks, sest naaste võib esineda eri tüüpi dementsuse korral ja samuti mõnel sümptomita eakal inimesel.
English: The study looked at sensitivity and specificity of the PET scans (how well they identified volunteers with plaques in the brain and how accurate they were in distinguishing them from those who did not).
Estonian: Uuringus vaadeldi PET-uuringute tundlikkust ja spetsiifilisust (kui hästi need tuvastasid vabatahtlikke, kelle ajus olid naastud, uuritavatest, kelle ajus naaste ei olnud).
English: Why is Neuraceq approved?
Estonian: Miks Neuraceq heaks kiideti?
English: What are the risks associated with Neuraceq?
Estonian: Mis riskid Neuraceqiga kaasnevad?
English: After the image is obtained, it is read by physicians specially trained in interpreting PET scans with Neuraceq.
Estonian: Pärast kujutise tegemist vaatavad seda arstid, kes on saanud spetsiaalse väljaõppe Neuraceqiga tehtud PET-uuringute tulemuste tõlgendamises.
English: At the planned end of the study, 31 patients had died and had autopsies carried out on them to prove whether or not they had significant amounts of β-amyloid plaques in their brains.
Estonian: Uuringu plaanitud lõpuks oli 31 patsienti surnud ja neile tehti lahangud, et kindlaks teha, kas neil oli ajus olulisel määral beetaamüloidnaaste.
English: The active substance in Neuraceq, florbetaben (18F), is a type of medicine known as a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Estonian: Neuraceqi toimeaine florbetabeen (18F) on radiofarmatseutikumiks nimetatav ravim, mis emiteerib väikeses koguses kiirgust ja kinnitub beeta-amüloidnaastudele ajus.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neuraceq, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Neuraceqi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: After it attaches to the plaques, the radiation it emits can be detected by the PET scanner, enabling doctors to see whether or not significant amounts of plaques are present.
Estonian: Pärast naastudele kinnitumist saab ravimi emiteeritavat kiirgust tuvastada PET-skanneriga, mis võimaldab arstidel näha, kas ajus leidub olulisel arvul naaste või mitte.
English: For practical information about using Neuraceq, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Neuraceqi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: With regard to the safety profile of Neuraceq, this was considered reassuring, with the most common adverse events being related to injection site reactions.
Estonian: Neuraceqi ohutusprofiili puhul peeti positiivseks seda, et enamus kõrvalnähte olid seotud süstekoha reaktsioonidega.
English: Neuraceq is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β‑amyloid plaques in the brain.
Estonian: Neuraceqi kasutatakse mäluprobleemidega patsientide aju-uuringutel, et arstid saaksid tuvastada, kas patsientide ajus on olulisel määral beeta-amüloidnaaste.
English: Neuraceq can only be obtained with a prescription, and PET scans with Neuraceq should only be requested by doctors experienced in the management of patients with diseases such as Alzheimer's and other dementias.
Estonian: Neuraceq on retseptiravim ja PET-uuringule Neuraceqiga peab suunama arst, kes on kogenud selliste haigustega (Alzheimeri tõbi ja muud dementsused) patsientide ravis.
English: How does Neuraceq work?
Estonian: Kuidas Neuraceq toimib?
English: For more information about treatment with Neuraceq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Neuraceqiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: How is Neuraceq used?
Estonian: Kuidas Neuraceqi kasutatakse?
English: Results from the main study demonstrated that PET scans with Neuraceq have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Estonian: Põhiuuringu tulemused näitasid, et PETuuringutel Neuraceqiga on kõrge tundlikkus ja spetsiifilisus beeta-amüloidnaastude avastamisel ajus ja et uuringutulemused olid sarnased lahangutulemustega.
English: What benefits of Neuraceq have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Neuraceqi kasulikkus?
English: For the full list of all side effects and restrictions with Neuraceq, see the package leaflet.
Estonian: Neuraceqi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: PET scans with Neuraceq were shown to have high specificity and sensitivity when used for identifying patients with significant amounts of β-amyloid plaques in the brain.
Estonian: Selgus, et PET-uuringutel Neuraceqiga oli kõrge spetsiifilisus ja tundlikkus nende patsientide tuvastamisel, kelle ajus leidus olulisel arvul beeta-amüloidnaaste.
English: Xgeva has been authorised since July 2011.
Estonian: Xgeva sai müügiloa alates juulist 2011.
English: The full European Public Assessment Report for Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Xgeva kohta on ameti veebilehel ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Xgeva?
Estonian: Mis on Xgeva?
English: The company presented the results of a study involving 33 patients with hypercalcaemia.
Estonian: Ettevõte esitas tulemused uuringu kohta, milles osales 33 hüperkaltseemiaga patsienti.
English: It is used in patients who cannot be treated by surgery or in whom surgery would cause severe problems.
Estonian: Ravimit kasutatakse patsientidel, keda ei saa ravida kirurgiliselt või kellel kirurgiline ravi põhjustaks raskeid probleeme.
English: The main measure of effectiveness was based on the number of patients who had a response to treatment, defined as having their blood calcium levels reduced to 2.9 mmol/l or lower within 10 days of the first dose.
Estonian: Efektiivsuse põhinäitaja oli ravivastusega patsientide arv ning ravivastust määratleti vere kaltsiumisisalduse vähenemisena tasemele 2,9 mmol/l või alla selle 10 päeva jooksul alates esimese annuse manustamisest.
English: This reduces the loss of bone, making fractures and other serious bone complications less likely to happen, and also lowers calcium levels in the blood.
Estonian: See vähendab luukoe hävimist, vähendades luumurdude ja muude luukahjustuste riski, ning vähendab ka kaltsiumisisaldust veres.
English: On 13 January 2017, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Xgeva to be used to treat hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer).
Estonian: Amgen Europe BV teatas 13. jaanuaril 2017 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Xgeva taotlus Xgeva kasutamiseks pahaloomulisest kasvajast tingitud hüperkaltseemia (suur kaltsiumisisaldus veres) raviks.
English: High calcium levels are a serious complication that can affect cancer patients in the last stages of their disease.
Estonian: Kaltsiumisisalduse suurenemine on raske tüsistus, mis võib esineda viimastes haigusstaadiumites vähipatsientidel.
English: By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Estonian: RANKLiga seondumise ja selle blokeerimisega vähendab denosumaab osteoklastide teket ja aktiivsust.
English: How does Xgeva work?
Estonian: Kuidas Xgeva toimib?
English: Xgeva was not compared with any other treatment in this study.
Estonian: Uuringus ei võrreldud Xgevat ühegi muu ravimiga.
English: What is happening with Xgeva for the prevention and treatment of other diseases?
Estonian: Kuidas mõjutab taotluse tagasivõtmine Xgeva kasutamist teiste haiguste ennetamiseks/raviks?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not sufficient and concluded that the medicine could not have been approved based on the data presented by the company.
Estonian: Seetõttu oli inimravimite komitee taotluse tagasivõtmise ajal arvamusel, et uuringu tulemusi ei saa pidada piisavaks, ning otsustas, et ettevõtte esitatud andmete alusel ei saa ravimit heaks kiita.
English: These complications include fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications requiring radiotherapy (treatment with radiation) or surgery.
Estonian: Sellised luukahjustused on luumurrud, seljaaju kompressioon (seljaaju pitsumine luude vahel) või kiiritusravi või kirurgilist ravi vajavad kahjustused.
English: RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Estonian: RANKL osaleb osteoklastide ehk luukoe lagunemises osalevate organismirakkude aktiveerimises.
English: The company informed the CHMP that there are currently no ongoing clinical trials or compassionate use programmes with Xgeva.
Estonian: Ettevõte teatas inimravimite komiteele, et Xgeva kliinilisi uuringuid ega eriloaga kasutamise programme praegu ei toimu.
English: Additionally, since patients were being treated with other hypercalcaemia treatments or had recently stopped treatment with bisphosphonates, it was not possible to determine the scale of the effect or whether the benefits observed in the study were due to Xgeva or were the effects of these other treatments.
Estonian: Kuna patsiendid said ravi ka muude hüperkaltseemiaravimitega või olid hiljuti lõpetanud bisfosfonaatravi, ei olnud võimalik kindlaks määrata ravitoime määra ega seda, kas uuringus täheldatud kasulikkus oli seotud Xgeva või kõnealuste muude ravimitega.
English: The CHMP considered that there were several problems with the main study which did not allow the Committee to conclude on the effectiveness of Xgeva: the study did not compare Xgeva with any other treatments and only included a small number of patients; it was not certain whether the patients' condition had responded to bisphosphonates, as the patients' previous calcium levels were not available.
Estonian: Inimravimite komitee tegi seoses põhiuuringuga kindlaks mitu probleemi, mille tõttu ei olnud komiteel võimalik teha lõplikke järeldusi Xgeva efektiivsuse kohta: uuringus ei võrreldud Xgevat ühegi muu ravimiga ning patsiendipopulatsioon oli väike, ühtlasi ei olnud piisavat kindlust bisfosfonaatravi toime suhtes patsientidel, kuna nende ravieelne kaltsiumisisaldus ei olnud teada.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application because the CHMP considered the data provided insufficient to conclude that the benefits of Xgeva outweighed its risks in the treatment of hypercalcaemia caused by cancer.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et võtab taotluse tagasi, kuna inimravimite komitee arvates ei tõendanud esitatud andmed piisavalt, et Xgeva kasulikkus on vähist tingitud hüperkaltseemia ravis suurem kui sellega kaasnevad riskid.
English: What was Xgeva expected to be used for?
Estonian: Milleks kavatseti Xgevat kasutada?
English: Xgeva was also expected to be used to reduce hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer) that did not respond to previous treatment with medicines called bisphosphonates.
Estonian: Xgevat kavatseti kasutada ka pahaloomulisest kasvajast tingitud hüperkaltseemia (suur kaltsiumisisaldus veres) vähendamiseks, kui varasem ravi bisfosfonaatidega ei ole ravivastust andnud.
English: The active substance in Xgeva, denosumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called RANKL.
Estonian: Xgeva toimeaine denosumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära RANKLiks nimetatava valgu ja seondub sellega.
English: Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed.
Estonian: Xgevat kasutatakse ka hiidrakuliseks luukasvajaks nimetatava luuvähi raviks täiskasvanutel ja väljaarenenud luustikuga noorukitel.
English: There are no consequences for the use of Xgeva in its authorised indications.
Estonian: Taotluse tagasivõtmine ei avalda mõju Xgeva kasutamisele heakskiidetud näidustustel.
English: It contains the active substance denosumab and is available as a solution to be injected under the skin.
Estonian: Ravim sisaldab toimeainena denosumaabi ja seda turustatakse nahaaluseks süstimiseks ette nähtud lahusena.
English: Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Xgeva could not have been approved for the treatment of hypercalcaemia caused by cancer and which did not respond to treatment with bisphosphonates.
Estonian: Tuginedes esitatud andmete analüüsile, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Xgeva kasutamist vähist tingitud ja bisfosfonaatravile allumatu hüperkaltseemia raviks ei ole võimalik heaks kiita.
English: Xgeva is a medicine used to prevent bone complications in adults with a solid tumour that has spread to the bone.
Estonian: Xgevat kasutatakse luukahjustuste ennetamiseks luudesse levinud soliidtuumoriga täiskasvanutel.
English: There were also concerns over the quality of the medicine.
Estonian: Väljendati ettevaatlikkust ka ravimi kvaliteedi suhtes.
English: In addition, the Committee did not consider the main measure of effectiveness to be appropriate for this type of study.
Estonian: Peale selle ei pidanud komitee efektiivsuse peamist mõõtu seda liiki uuringule sobivaks.
English: International non-proprietary name (INN): fluocinolone acetonide
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): fluotsinoloonatsetoniid
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Estonian: Ettevõtte taotluse tagasivõtmise kiri, millega ettevõte EMEAt taotluse tagasivõtmisest teavitas, on kättesaadav siin.
English: What is RETISERT?
Estonian: Mis on RETISERT?
English: The main measure of effectiveness was the time taken until the disease came back.
Estonian: Efektiivsust mõõdeti põhiliselt aja järgi, mis kulus haiguse tagasitulekuks.
English: RETISERT was studied in one main study involving 146 patients who had had non-infectious uveitis affecting the posterior part of one or both eyes for at least a year, and had been treated with corticosteroids or immunosuppressant medicines for at least a month.
Estonian: RETISERTi uuriti ühes põhiuuringus, milles osales 146 patsienti, kellel oli olnud vähemalt ühe aasta jooksul ühe või mõlema silma posterioorne mittenakkuslik uveiit ja keda oli ravitud vähemalt ühe kuu jooksul kortikosteroidide või immunosupressantidega.
English: On 16 July 2007, Bausch & Lomb Ireland officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for RETISERT, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. RETISERT was designated an orphan medicinal product on 7 March 2005.
Estonian: 16. juulil 2007 teatas Bausch & Lomb Ireland ametlikult inimtervishoius kasutatavate ravimite komiteele oma otsusest võtta tagasi ravimi RETISERT müügiloa taotlus kroonilise mittenakkusliku posterioorse uveiidi raviks.
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to the questions.
Estonian: Inimtervishoius kasutatavate ravimite komitee oli koostanud ettevõttele vastamiseks küsimuste loetelu, kuid ettevõte ei olnud neile vastanud.
English: The use of RETISERT was also linked to side effects, including eye pain, increased pressure within the eyeball and cataracts, which led to vision problems in some patients.
Estonian: RETISERTi kasutamisega kaasnes ka kõrvalnähte, sealhulgas silmavalu, silmarõhu suurenemine silmamunas ja kae, mis põhjustas teatud patsientidel probleeme.
English: The study was still ongoing at the time of assessment, but was designed to last a total of three years.
Estonian: Ravimi hindamise ajal ei olnud uuring lõppenud, sest selle kavandatud kestus oli kokku kolm aastat.
English: It acts like corticosteroids (a family of naturally occurring hormones) by dampening down the activity of the immune system and reducing inflammation.
Estonian: See toimib nagu kortikosteroidid (rühm looduslikke hormoone), pärssides immuunsüsteemi aktiivsust ja vähendades põletikku.
English: The company informed the CHMP that there are no clinical trials with RETISERT ongoing in Europe.
Estonian: Ettevõte teatas inimtervishoius kasutatavate ravimite komiteele, et Euroopas ei toimu praegu RETISERTi kliinilisi uuringuid.
English: It contains the active substance fluocinolone acetonide, which is released slowly by the implant over a period of around three years.
Estonian: Ravim sisaldab toimeainena fluotsinoloonatsetoniidi, mida implantaat vabastab aeglaselt ligikaudu kolme aasta jooksul.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of RETISERT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Estonian: Seetõttu oli inimtervishoius kasutatavate ravimite komitee taotluse tagasivõtmise ajal seisukohal, et RETISERTi kasulikkust ei olnud piisavalt tõendatud ning et selle võimalik kasulikkus ei ole suurem väljaselgitatud ohtudest.
English: Ref. EMEA/342023/2007
Estonian: London, 16. august 2007 Viitedokument EMEA/482589/2007
English: The effects of RETISERT, implanted into the more severely affected eye, were compared to those of standard care (the use of corticosteroids or immunosuppressant medicines affecting the whole body).
Estonian: Võrreldi raskemini kahjustatud silma implanteeritud RETISERTi toimet tavapärase raviga (kogu organismile mõju avaldavate kortikosteroidide või immunosupressantide kasutamisega).
English: This is inflammation within the eye, which is not caused by an infection, but which affects areas including the retina (the light-sensitive layer at the back of the eye), and the choroid (the layer below the retina that contains blood vessels).
Estonian: See on silmapõletik, mis ei ole põhjustatud nakkusest, vaid kahjustab muude piirkondade hulgas võrkkesta (valgustundlik kiht silma tagaosas) ja soonkesta (võrkkesta all olev veresoonterikas kiht).