FrancophonIA/ELRC3.0 huggingface dataset:
English: They are used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Estonian: Neid kasutatakse skisofreeniaga patsientidel - skisofreenia on vaimuhaigus, millel on mitmeid sümptomeid, sealhulgas mõtlemis- ja kõnehäired, hallutsinatsioonid (ebareaalsete asjade nägemine või kuulmine), kahtlustamine ja luulud.
English: • treatment of schizophrenia;
Estonian: • skisofreenia ravi;
English: Since these neurotransmitters are involved in schizophrenia, bipolar disorder and major depression, quetiapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Estonian: Et need neurotransmitterid on seotud skisofreenia, bipolaarse häire ja raske depressiooniga, aitab kvetiapiin ajutalitlust normaliseerida ja nende haiguste sümptomeid leevendada.
English: Additionally, the data available show that newborns who were exposed to antipsychotics (including quetiapine) during late pregnancy (third trimester) are at risk of side effects including agitation, somnolence, breathing and feeding problems.
Estonian: Lisaks näitavad olemasolevad andmed, et vastsündinutel, kes puutusid raseduse hilises järgus (viimasel kolmandikul) kokku antipsühhootikumidega (sealhulgas kvetiapiiniga), on kõrvalnähtude, sealhulgas rahutuse, unisuse, hingamis- ja söötmisprobleemide tekke oht.
English: What are Seroquel and Seroquel XR?
Estonian: Mis on Seroquel ja Seroquel XR?
English: On 12 June 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Seroquel and Seroquel XR in the EU.
Estonian: 12. juunil 2013 tegi Euroopa Komisjon inimravimite komiteele esildise, et ühtlustada Seroqueli ja Seroquel XRi müügiload Euroopa Liidus.
English: • prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment.
Estonian: • maania- või depressiooniepisoodide kordumise ennetamine bipolaarse häirega patsientidel, kellel tekkis varem kvetiapiiniga ravivastus.
English: Seroquel and Seroquel XR are also marketed under other trade names.
Estonian: Seroqueli ja Seroquel XRi turustatakse ka teiste kaubanduslike nimetuste all.
English: Seroquel and Seroquel XR are authorised in the EU via national procedures.
Estonian: Seroquel ja Seroquel XR on ELis riiklike menetlustega heaks kiidetud.
English: Seroquel XR can also continue to be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.
Estonian: Seroquel XRi võib jätkuvalt kasutada ka lisaravimina raskete depressiooniepisoodide ravis depressiivhäirega patsientidel, kelle ravivastus teistele antidepressantidele ei ole piisav.
English: They are also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression.
Estonian: Neid kasutatakse ka bipolaarse meeleoluhäire ennetuses ja ravis - see on vaimuhaigus, mille korral patsientide maaniaepisoodid (meeleolu äärmuslik tõus) vahelduvad normaalse meeleolu perioodide ja depressiooniepisoodidega.
English: Seroquel and Seroquel XR are antipsychotic medicines that contain the active substance quetiapine.
Estonian: Seroquel ja Seroquel XR on antipsühhootikumid, mis sisaldavad toimeainena kvetiapiini.
English: This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Estonian: Seetõttu on ravimi näidustused, ravimi omaduste kokkuvõtted, märgistus ja pakendi infoleht ravimeid turustavates liikmesriikides erinevad.
English: On 22 May 2014, the European Medicines Agency completed a review of Seroquel and Seroquel XR.
Estonian: Euroopa Ravimiamet lõpetas 22. mail 2014 Seroqueli ja Seroquel XRi kohta tehtud taotluse läbivaatamise.
English: • treatment of moderate to severe manic episodes in bipolar disorder and major depressive episodes in bipolar disorder;
Estonian: • bipolaarse häire mõõdukate kuni raskete maaniaepisoodide ravi ja bipolaarse häire raskete depressiooniepisoodide ravi;
English: Seroquel XR can also be used as add-on treatment in major depression.
Estonian: Seroquel XRi võib kasutada ka täiendava ravimina raske depressiooni korral.
English: Why were Seroquel and Seroquel XR reviewed?
Estonian: Miks Seroqueli ja Seroquel XRi taotlus uuesti üle vaadati?
English: Questions and answers on Seroquel, Seroquel XR and associated names (quetiapine)
Estonian: Seroqueli, Seroquel XRi ja sarnaste nimetuste teave (kvetiapiin)
English: As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this affects signals transmitted between brain cells.
Estonian: See häirib neurotransmitterite vahendatavaid närvisignaale.
English: Seroquel and Seroquel XR were identified by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) as needing harmonisation.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm nimetas Seroqueli ja Seroquel XRi ühtlustamist vajavateks ravimiteks.
English: EMA/206629/2016 EMEA/H/C/000609
Estonian: EU/1/05/314/001
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kepivance on 25 October 2005.
Estonian: Müügiloa esmase väljastamise kuupäev: 25. oktoober 2005
English: How does Kepivance work?
Estonian: Kuidas Kepivance'i kasutada
English: The use of Kepivance should be supervised by a doctor who has experience in anticancer therapy.
Estonian: Kepivance'i manustab teile arst või õde, kellel on vähivastase ravi alal kogemusi.
English: It contains the active substance
Estonian: Infolehe sisukord
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Estonian: 5550 Airport Boulevard Boulder, Colorado 80301 Ameerika Ühendriigid
English: Palifermin is very similar to a natural growth factor found in the body called keratinocyte growth factor (KGF).
Estonian: Palifermiin toimib samamoodi kui keratinotsüütide kasvufaktor (KGF), mida tekib kehas väikestes kogustes loomulikul teel.
English: Kepivance stimulates the growth of the epithelial cells, helping to reduce the incidence, severity and duration of oral mucositis in cancer patients undergoing intensive therapy.
Estonian: Kepivance'i kasutatakse oraalse mukosiidi sümptomite esinemissageduse, kestuse ja raskusastme vähendamiseks.
English: Patients receiving Kepivance also reported less mouth and throat soreness with improved swallowing, drinking, eating and talking.
Estonian: See 3. faasi kliiniline uuring näitas olulist kasu palifermiiniga ravitud patsientidel, mis patsientide hinnangu põhjal seisnes suu ja kurgu valulikkuse vähenemises ja selle mõjus neelamisele, joomisele, söömisele ja rääkimisele.
English: Three doses are given on three consecutive days before myeloablative therapy, finishing 24 to 48 hours before the therapy.
Estonian: Kolmest doosist viimane tuleb manustada vähemalt 24-48 tundi enne kemoteraapia ja radioteraapia algust.
English: Kepivance is a powder that is made up into a solution for injection.
Estonian: Kepivance on steriilne säilitusaineteta ravim, mis on mõeldud ühekordseks kasutamiseks.
English: Other information about Kepivance:
Estonian: Väga sage: Sage:
English: Palifermin is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce palifermin.
Estonian: Palifermiin on inimese keratinotsüütide kasvufaktor (KGF), mis on toodetud rekombinantse DNA tehnoloogia abil Esherichia coli tüvest.
English: The most common side effects with Kepivance (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), increased levels of lipase and amylase (enzymes used in digestion), hypertrophy (increase in the number or size of cells) or discoloration of the mouth and tongue, rash, pruritus (itching), erythema (redness), arthralgia (joint pain), oedema (swelling), pain and pyrexia (fever).
Estonian: Sagedaseimad kõrvaltoimed (enam kui ühel patsiendil kümnest) olid Kepivance'i farmakoloogilisele toimele vastavad reaktsioonid naha ja suu epiteelil, nt tursed (sh perifeersed tursed) ja suu struktuuride hüpertroofia).
English: The main measure of effectiveness was the number of days during which patients experienced severe oral
Estonian: Uuringu peamine tulemusnäitaja oli päevade arv, mil patsiendil esines raskekujuline oraalne mukosiit (raskusaste 3/4 Maailma Tervishoiuorganisatsiooni (WHO) skaala järgi).
English: The active substance in Kepivance, palifermin, is a growth factor that stimulates the ‘epithelial' cells that line the mouth and gastrointestinal tract to grow and develop.
Estonian: Palifermiin stimuleerib spetsiifiliste rakkude kasvu, mida nimetatakse epiteelrakkudeks ja mis vooderdavad suud ja seedekulglat nagu ka teisi kudesid, nt nahka.
English: Kepivance is used in adults who are likely to develop severe mucositis because they have blood cancer, and are being treated with myeloablative chemotherapy (medicines to destroy the bone marrow) in combination with radiotherapy (treatment with radiation) and an autologous haematopoietic stem-cell transplant (a transplant of their own blood-producing cells).
Estonian: Teie verevähki võidakse ravida kemoteraapia, radioteraapia ja autoloogsete hematopoeetiliste tüvirakkude siirdamisega (teie kehast pärinevad rakud, mis toodavad vererakke).
English: However, in the study of patients receiving chemotherapy without radiation, there was no difference in the severity of mucositis between the patients receiving placebo and those receiving either schedule of Kepivance.
Estonian: Hematopoeetilise taastumise aeglustumist palifermiini rühma patsientidel, võrreldes platseebot saanud patsientidega ei täheldatud.
English: Kepivance should not be used in people who may be hypersensitive (allergic) to palifermin, proteins produced by Escherichia coli (a bacterium) or any of the other ingredients.
Estonian: - kui te olete palifermiini, selle ravimi mis tahes koostisosade (loetletud lõigus 6) või Escherichia coli'st pärinevate valkude suhtes allergiline.
English: The study involved 281 adults who were receiving chemotherapy to treat multiple myeloma (a type of blood cancer), but without any radiotherapy.
Estonian: Selles uuringus said hulgimüeloomiga patsiendid (n = 281) enne autoloogset vereloome tüvirakkude siirdamist eelravi melfalaaniga (200 mg/m2).
English: This summary was last updated in 03-2016.
Estonian: Infoleht on viimati uuendatud
English: Epithelial cells in the mouth are normally replaced by the body every few days.
Estonian: Kepivance'i tavaline annus on 60 mikrogrammi Kepivance'i kilogrammi kehakaalu kohta päevas.
English: Kepivance has been compared with placebo (a dummy treatment) in one main study in 212 adults receiving chemotherapy and radiotherapy for a blood cancer (mostly non-Hodgkin's lymphoma).
Estonian: Palifermiini kliiniline programm hõlmas 3 randomiseeritud platseebo-kontrollitud kliinilist uuringut ja farmakokineetilist uuringut, milles osales kokku 650 vereloomekasvajaga patsienti, kes said müelotoksilist ravi koos vajaliku vereloome tüvirakkude (HSC) toetamisega.
English: At the request of the CHMP, the company carried out a further study comparing two schedules of Kepivance with placebo.
Estonian: Uuringus oli kolm ravirühma ning uuringu eesmärk oli võrrelda kahte palifermiini rühma (pre- ja pre/post-) platseeboga.
English: For the full list of all side effects reported with Kepivance, see the package leaflet.
Estonian: Pakendi sisu ja muu teave Mida Kepivance sisaldab
English: The remaining three doses are given on three consecutive days after myeloablative therapy, with the first dose given on the day of the stem-cell transplant.
Estonian: Palifermiini manustati intravenoosse süstena 60 mikrogrammi/kg päevas 3 järjestikusel päeval enne tsütotoksilise ravi algust ja 3 järjestikusel päeval pärast perifeerse vere tüvirakkude infusiooni, nii et viimase ravieelse annuse ja esimese ravijärgse annuse vahele jäi üheksa päeva.
English: This document is a summary of the European Public Assessment Report (EPAR) for Kepivance.
Estonian: Täpne teave selle ravimi kohta on Euroopa Ravimiameti kodulehel http://www.ema.europa.eu
English: In the main study, the patients receiving chemotherapy and radiotherapy had severe oral mucositis for a shorter time if they received Kepivance (3.7 days, on average) than if they received placebo (10.4 days, on average).
Estonian: Peale selle esines rohkem infektsioone patsientidel, kellele manustati enne ja pärast kemoteraapiat palifermiini (49,5%), võrreldes platseebot saanud patsientidega (24,6%).
English: Kepivance is used to decrease the frequency, duration and severity of oral mucositis (inflammation of the lining of the mouth, ranging from soreness and redness to severe ulceration).
Estonian: Kepivance'i kasutatakse oraalse mukosiidi (suu valulikkus, kuivus ja paistetus) raviks, mis tekib verevähi ravi kõrvaltoimena.
English: The replacement palifermin acts in the same way as naturally produced KGF.
Estonian: Vereloomekasvajatel ei ole KGF-retseptoreid.
English: The medicine can only be obtained with a prescription.
Estonian: Palifermiini ei tohi kasutada ainult müeloablatiivset keemiaravi hõlmavas ravis.
English: It is given as an injection into a vein for a total of six doses.
Estonian: Iga pakend sisaldab 6 viaali.
English: For more information about treatment with Kepivance, read the package leaflet (also part of the EPAR).
Estonian: Ainult ühekordseks kasutamiseks Enne ravimi kasutamist lugege pakendi infolehte Intravenoosne
English: What benefit has Kepivance shown during the studies?
Estonian: Kliinilistest uuringutest ja spontaansete teadete põhjal saadud kõrvaltoimed.
English: The full EPAR for Kepivance can be found here.
Estonian: Hepariini ja Kepivance'i koos kasutamine võib põhjustada koostoimeid.
English: The studies will include children below 2 years of age, for whom there are currently no data.
Estonian: Uuringutesse kaasatakse alla 2-aastased lapsed, kelle kohta praegu andmed puuduvad.
English: This study is still ongoing.
Estonian: Uuring veel kestab.
English: A patient's final score was the sum of the two scores.
Estonian: Patsiendi lõplik skoor oli kummagi skoori summa.
English: The treatment can continue for as long as the patient benefits from it.
Estonian: Ravi tohib jätkata seni, kuni see on patsiendile kasulik.
English: With regard to its safety, the data do not reveal any unacceptable concerns.
Estonian: Andmetest ei nähtu vastuvõetamatuid ohutusprobleeme.
English: What measures are being taken to ensure the safe and effective use of Brineura?
Estonian: Mis meetmed võetakse, et tagada Brineura ohutu ja efektiivne kasutamine?
English: In a study in which 23 children (average age of 4 years) were treated with Brineura for almost a year, 20 of them (87%) did not experience the 2-point decline in movement and language skills seen historically in patients not receiving treatment.
Estonian: Ühes uuringus said 23 last (keskmine vanus 4 aastat) Brineura-ravi peaaegu aasta vältel, neist 20 lapsel (87%) ei esinenud motoorse ja kõnefunktsiooni skoori 2-punktilist langust, mida on varem täheldatud ravimata patsientidel.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Brineura's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee järeldas seetõttu, et Brineura kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Other information about Brineura
Estonian: Muu teave Brineura kohta
English: Since Brineura has been approved under exceptional circumstances, the company that markets it will provide further data from studies on the safety of Brineura, including the risk of allergic reactions when used long-term, and on its long-term effectiveness in delaying or stopping worsening of movement and language skills.
Estonian: Et Brineura on saanud müügiloa erandkorras, esitab ravimi turustaja täiendavad andmed Brineura ohutuse uuringutest, sealhulgas allergiliste reaktsioonide riski kohta pikaajalisel kasutamisel ning pikaajalise efektiivsuse kohta motoorsete ja kõneoskuste halvenemise edasilükkamisel või peatamisel.
English: This is a summary of the European public assessment report (EPAR) for Brineura.
Estonian: See on ravimi Brineura Euroopa avaliku hindamisaruande kokkuvõte.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Brineura can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Brineura kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Brineura or the infusion may be slowed down.
Estonian: Infusioonireaktsioonide riski vähendamiseks võidakse patsientidele anda Brineuraga toimuva ravi eel või ajal muid ravimeid, samuti võidakse infusiooni aeglustada.
English: The full EPAR for Brineura can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Brineura kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Brineura is a medicine for treating neuronal ceroid lipofuscinosis type 2 (CLN2 disease), an inherited condition in children that leads to progressive brain damage.
Estonian: Brineura on ravim, mida kasutatakse II tüüpi neuronaalse tseroidse lipofustsinoosi (CLN2) raviks; see on lastel esinev pärilik haigus, mis põhjustab progresseeruvat ajukahjustust.
English: The most common side effects with Brineura (which may affect more than 1 in 5 people) are fever, low levels of protein in CSF (the fluid in the brain and spinal cord), abnormalities in ECG (a test of the heart's activity), vomiting, upper respiratory tract infections (nose and throat infections), and hypersensitivity (allergic) reactions.
Estonian: Brineura kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 5st) on palavik, tserebrospinaalvedeliku (pea- ja seljaajuvedelik) väike valgusisaldus, EKG (südame elektritalitluse teatud uuringu) ebanormaalsed tulemused, oksendamine, ülemiste hingamisteede (nina- ja kõri) infektsioonid ja allergilised (ülitundlikkus-) reaktsioonid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Brineura have also been included in the summary of product characteristics and the package leaflet.
Estonian: Brineura ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The company that markets Brineura will ensure that all healthcare professionals expected to use this medicine are provided with training material on how to use it and how to avoid problems with the device such as infection or blockage.
Estonian: Brineura turustaja varustab kõik ravimit eeldatavalt kasutavad tervishoiutöötajad teabematerjaliga, kuidas ravimit kasutada ja vältida seadmega kaasnevaid probleeme, näiteks infektsioone või ummistumist.
English: The active substance in Brineura, cerliponase alfa, is a copy of TPP1 and is used as a replacement for the missing enzyme.
Estonian: Brineura toimeaine alfatserliponaas on TPP1 koopia, mis asendab puuduva ensüümi asendamiseks.
English: This is because it has not been possible to obtain complete information about Brineura due to the rarity of the disease.
Estonian: See tähendab, et harvaesineva haiguse tõttu ei olnud võimalik saada Brineura kohta täielikku teavet.
English: In a follow-up study the benefits of Brineura lasted for another year, with the results showing the disease could be delayed in the majority of patients.
Estonian: Järeluuringus täheldati Brineura kasuliku toime püsimist veel ühe aasta vältel ning tulemused tõendasid, et enamikul patsientidel on võimalik haiguse progresseerumist edasi lükata.
English: Brineura contains the active substance cerliponase alfa.
Estonian: Brineura sisaldab toimeainena alfatserliponaasi.
English: What is Brineura and what is it used for?
Estonian: Mis on Brineura ja milleks seda kasutatakse?
English: The medicine is infused directly into the brain in order to bypass the blood-brain barrier, a protective barrier that separates the blood stream from the brain, and prevents substances such as medicines, from entering brain tissue.
Estonian: Ravimit manustatakse infusioonina otse ajju, et mitte kahjustada hematoentsefaalbarjäärikaitsebarjääri, mis eraldab vereringet ajust ning takistab ainete, näiteks ravimite sattumist ajukoesse.
English: Why is Brineura approved?
Estonian: Miks Brineura heaks kiideti?
English: Brineura cerliponase alfa
Estonian: Brineura alfatserliponaas
English: The infusions are given once every two weeks by a healthcare professional knowledgeable about giving medicines into the brain.
Estonian: Ravimit manustab infusioonina iga kahe nädala järel ravimite ajusisese manustamise eriteadmistega tervishoiutöötaja.
English: Patients with CLN2 lack an enzyme required for normal brain development called tripeptidyl-peptidase1 (TPP1).
Estonian: II tüüpi neuronaalse tseroidse lipofustsinoosiga patsientidel puudub aju normaalseks arenguks vajalik ensüüm tripeptidüül-peptidaas-1 (TPP1).
English: What are the risks associated with Brineura?
Estonian: Mis riskid Brineuraga kaasnevad?
English: What information is still awaited for Brineura?
Estonian: Mis teavet Brineura kohta veel oodatakse?
English: For more information about treatment with Brineura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Brineuraga 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 Brineura used?
Estonian: Kuidas Brineurat kasutatakse?
English: Brineura must not be given to patients who have experienced life-threatening hypersensitivity (allergic) reactions with Brineura and whose symptoms re-occurred when Brineura was given again.
Estonian: Brineurat ei tohi kasutada patsiendid, kellel on esinenud eluohtlik allergiline reaktsioon Brineura suhtes ja kelle sümptomid Brineuraga toimuva ravi taasalustamisel taastusid.
English: The rating was done by doctors who gave patients individual scores for movement and language skills (where 0 means most severe and 3 is normal).
Estonian: Uuringus hindasid arstid iga patsiendi motoorset ja kõnefunktsiooni (skoor 0 tähendas tugevalt vähenenud funktsiooni ja 3 normaalset).
English: Because the number of patients with CLN2 is low, the disease is considered ‘rare', and Brineura was designated an ‘orphan medicine' (a medicine used in rare diseases) on 13 March 2013.
Estonian: Et II tüüpi neuronaalse tseroidse lipofustsinoosiga patsientide arv on väike ja see haigus esineb harva, nimetati Brineura 13. märtsil 2013 harvikravimiks.
English: Brineura has been shown in early studies to reduce the rate at which the disease worsens as measured with standard rating scale.
Estonian: Brineura on esimestes uuringutes osutunud standardse hindamisskaala alusel efektiivseks haiguse progresseerumise aeglustamisel.
English: For the full list of all side effects reported with Brineura, see the package leaflet.
Estonian: Brineura kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.