FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC considered that further minimisation measures of the known risk of infection related to the use of idelalisib were necessary.
Estonian: et vajalikud on edasised teadaoleva infektsiooniriski vähendamise meetmed seoses idelalisiibi kasutamisega.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Zydelig (idelalisib).
Estonian: Seetõttu soovitab inimravimite komitee muuta Zydeligi (idelalisiib) müügiloa tingimusi.
English: The PRAC considered that the benefit-risk balance in this indication remained positive provided the risk minimisation measures are implemented.
Estonian: Ravimiohutuse riskihindamise komitee leidis, et kasulikkuse ja riski tasakaal sellel näidustusel jäi positiivseks, kui rakendatakse riski vähendamise meetmeid.
English: The PRAC considered the new interim safety data and very limited efficacy data from three studies (-0123,0124, -0125), that have been terminated, evaluating the addition of idelalisib to standard therapies in first line CLL and relapsed indolent non-Hodgkin lymphoma (iNHL)/small lymphocytic lymphoma (SLL) as well as the results of all other relevant trials including those that supported the above listed indications.
Estonian: Ravimiohutuse riskihindamise komitee kaalus uusi vahepealseid ohutusandmeid ja väga piiratud efektiivsusandmeid kolmest lõpetatud uuringust (-0123, -0124, -0125), mis hindasid idelalisiibi lisamist standardravile esmavalikuna CLL-i korral ja retsidiveerunud indolentse mitte-Hodgkini lümfoomi (iNHL) / väikese lümfotsütaarse lümfoomi (SLL) korral, ning kõigi muude asjakohaste uuringute, sealhulgas ülaltoodud näidustusi toetavate uuringute tulemusi.
English: However as patients with 17p deletion or TP53 mutation have a poor prognosis, the extrapolation of the positive results observed in relapsed/refractory subjects with 17p deletion or TP53 mutation that supported the initial granting of the indication in patients unsuitable for chemoimmunotherapy is not questioned.
Estonian: Et 17p deletsiooni või TP53 mutatsiooniga patsientidel on halb prognoos, ei vaidlustata retsidiiviga/refraktaarsetel 17p deletsiooni või TP53 mutatsiooniga patsientidel täheldatud positiivsete tulemuste ekstrapoleerimist, mis toetasid algset näidustuse heakskiitmist keemia-immuunraviks sobimatutel patsientidel.
English: • The PRAC reviewed the preliminary data provided by the marketing authorisation holder on the interim results of studies GS-US-312-0123, GS-US-313-0124, GS-US-313-0125 that suggested an increased risk of death and serious infection with idelalisib.
Estonian: • ravimiohutuse riskihindamise komitee vaatas üle ravimi müügiloa hoidja esitatud uuringute GSUS-312-0123, GS-US-313-0124, GS-US-313-0125 vahetulemuste esialgsed andmed, mis viitasid idelalisiibi kasutamisel esinevale suurenenud surmariskile ning raskete infektsioonide tekkimise riskile.
English: The benefit-risk balance of idelalisib in combination with rituximab in treatment naïve and relapsed/refractory CLL is therefore considered to remain positive provided the recommended risk minimisation measures are applied.
Estonian: Idelalisiibi ja rituksimabi kombinatsiooni kasulikkuse ja riski tasakaalu peetakse seetõttu endiselt positiivseks varem mitteravitud ning retsidiveerunud/refraktaarse CLL-iga patsientidel, kui rakendatakse soovitatavaid riski vähendamise meetmeid.
English: The CHMP discussed the statement proposed to be added in section 4.4 of the SmPC that limited efficacy and safety data explain why idelalisib is to be used as a first line treatment only in those patients with the 17p deletion or TP53 mutation who are not eligible for any other therapies.
Estonian: Inimravimite komitee arutas ravimi omaduste kokkuvõtte lõiku 4.4 lisamiseks väljapakutud väidet, et piiratud efektiivsus- ja ohutusandmed selgitavad, miks tohib idelalisiibi kasutada esmavaliku ravina ainult neil 17p deletsiooni või TP53 mutatsiooniga patsientidel, kellele ükski muu ravi ei sobi.
English: The PRAC considered that these measures should be applied for the use of idelalisib in combination with ofatumumab in CLL patients.
Estonian: Ravimiohutuse riskihindamise komitee järeldas, et neid meetmeid tuleb rakendada idelalisiibi kasutamiseks kombinatsioonis ofatumumabiga CLL-iga patsientidel.
English: In particular, PRAC recommended that treatment should not be initiated in patients with evidence of ongoing systemic infection, that patients should be monitored for respiratory signs and symptoms throughout treatment and advised to report new respiratory symptoms promptly.
Estonian: Konkreetselt soovitas ravimiohutuse riskihindamise komitee mitte alustada ravi patsientidel, kellel on on tõendatud jätkuv süsteemne infektsioon, ning jälgida patsientide respiratoorseid nähtusid ja sümptome kogu ravi ajal.
English: Idelalisib is also indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
Estonian: Idelalisiib on ka näidustatud täiskasvanutel monoteraapiana follikulaarse lümfoomi (FL) korral, mis ei ole allunud kahele eelnevale ravivalikule.
English: Zydelig (idelalisib) is a centrally authorised product and is currently indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Estonian: Zydelig (idelalisiib) on tsentraalse müügiloaga ravim, mille praegune näidustus on kasutamine kombinatsioonis rituksimabiga kroonilise lümfotsütaarse leukeemia (CLL) ravis täiskasvanutel, keda on varem ravitud vähemalt ühe muu ravimiga, või esmavalikuna patsientidel, kellele on keemiaimmuunravi vastunäidustatud 17p deletsiooni või TP53 mutatsiooni tõttu.
English: The PRAC concluded that the benefit-risk balance in the authorised indications remained positive, provided that first line treatment with idelalisib is only used in patients with 17p deletion or TP53 mutation that are not eligible for any other therapies and that changes are implemented in the product information to minimise the risk of serious infections.
Estonian: Ravimiohutuse riskihindamise komitee järeldas, et kasulikkuse ja riski tasakaal heakskiidetud näidustustel jäi positiivseks, kui idelalisiibi kasutatakse ainult neil 17p deletsiooni või TP53 mutatsiooniga patsientidel, kellele ei sobi ükski muu ravi, ja kui ravimiteabesse viiakse muudatused raskete infektsioonide riski vähendamise kohta.
English: For the same reasons, the relevance of the results of study -0123 is considered limited for the benefit-risk balance of idelalisib in combination with ofatumumab in the same types of CLL
Estonian: Samadel põhjustel peetakse uuringu -0123 tulemuste asjakohasust idelalisiibi ja ofatumumabi kombinatsiooni kasulikkuse ja riski tasakaalu hindamisel sama tüüpi CLL-iga patsientidel piiratuks.
English: This review was initiated due to a reported increased risk of death and higher incidence of serious adverse events (SAE) among subjects receiving idelalisib compared to the control groups observed in three clinical trials (GS-US-312-0123, GS-US-313-0124, GS-US-313-01251).
Estonian: Seda on täheldatud kolmes kliinilises uuringus (GS-US-312-0123, GS-US-313-0124, GS-US-313-01251).
English: The CHMP, as a consequence, considers that the benefit-risk balance of Zydelig (idelalisib) remains favourable subject to the amendments to the product information.
Estonian: Inimravimite komitee leiab, et Zydeligi (idelalisiib) kasulikkuse ja riski tasakaal jääb positiivseks, kui ravimiteabesse tehakse muudatused.
English: In particular an increased incidence of PJP, carrying a high risk of morbidity and mortality, was observed in the idelalisib treatment arms compared to controls in all the studies, and appeared to be significantly lower in patients administered PJP prophylaxis.
Estonian: Eriti täheldati kõigis uuringutes idelalisiibi ravirühmades võrreldes kontrollrühmaga haigestumuse ja suremuse suurt riski põhjustava PJP (Pneumocystis Jirovecii pneumoonia) suurenenud esinemissagedust, mis oli oluliselt väiksem patsientidel, kes said PJP profülaktikat.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Zydelig.
Estonian: Seega soovitab ravimiohutuse riskihindamise komitee muuta Zydeligi müügiloa tingimusi.
English: The PRAC considered the results of these studies of limited relevance for the benefit-risk balance of idelalisib in its authorised indications and ongoing extension of indication in combination with ofatumumab for the treatment of CLL.
Estonian: Ravimiohutuse riskihindamise komitee kaalus nende uuringute tulemusi, mille asjakohasus idelalisiibi kasulikkuse ja riski tasakaalu jaoks heakskiidetud näidustustel ning kehtiva näidustuse laienduse jaoks kombinatsioonis ofatumumabiga CLL-i raviks oli piiratud.
English: Nevertheless, in view of the limited data available in this subset and considering availability of other options for first line treatment for CLL patients, the PRAC was of the view that as a precaution, idelalisib should only be used in patients with 17p deletion or TP53 mutation if they are not eligible for any other therapies.
Estonian: Arvestades selle alarühma kohta olemasolevaid piiratud andmeid ja kaaludes muude võimaluste olemasolu CLL-iga patsientide esmavaliku raviks, oli ravimiohutuse riskihindamise komitee siiski arvamusel, et ettevaatusabinõuna võib idelalisiibi kasutada 17p deletsiooni või TP53 mutatsiooniga patsientidel ainult siis, kui ükski muu ravi neile ei sobi.
English: In view of the above, the PRAC concluded that the benefit-risk balance of Zydelig is favourable subject to changes to the product information, as described above.
Estonian: Kõige eeltoodu põhjal järeldas ravimiohutuse riskihindamise komitee, et Zydeligi kasulikkuse ja riski tasakaal jääb soodsaks, kui ravimiteabesse tehakse ülalkirjeldatud muudatused.
English: The PRAC noted that in study -0123, idelalisib was administered in combination with rituximab and bendamustine (an unauthorised combination) in previously untreated CLL patients with and without 17p deletion/TP53 mutation, which is not the same population as the one in the current CLL indication in first line.
Estonian: Ravimiohutuse riskihindamise komitee märkis, et uuringus0123 manustati idelalisiibi kombinatsioonis rituksimabi ja bendamustiiniga (heakskiitmata kombinatsioon) varem ravimata CLL-iga patsientidele, kellel esines 17p deletsioon / TP53 mutatsioon või mitte.
English: Nevertheless, as a precaution and in view of the fact that limited data are available in treatment-naïve CLL patients with 17p deletion or TP53 mutation, the PRAC recommended that idelalisib should only be used in this group of patients if they are not eligible for any other therapies.
Estonian: Ettevaatusabinõuna ja arvestades fakti, et varem mitteravitud 17p deletsiooniga või TP53 mutatsiooniga CLL-iga patsientide kohta on andmed piiratud, soovitas ravimiohutuse riskihindamise komitee siiski, et idelalisiibi kasutataks selles patsientide rühmas ainult siis, kui neile ei sobi ükski muu ravi;
English: Following the same precautionary principle, in view of the limited data available in treatment naïve patients with 17p deletion or TP53 mutation it was also considered that idelalisib in combination with ofatumumab should be only be used first-line in CLL patients with 17p deletion or TP53 mutation who are not eligible for any other therapies.
Estonian: Arvestades varem mitteravitud 17p deletsiooni või TP53 mutatsiooniga patsientide kohta kättesaadavaid piiratud andmeid, leiti sama ettevaatusprintsiibi kohaselt, et idelalisiibi kombinatsioonis ofatumumabiga võib kasutada esmavaliku raviks 17p deletsiooni või TP53 mutatsiooniga CLL-iga patsientidel, kellele ei sobi ükski muu ravi.
English: The results of study -0123 are considered of limited relevance to the benefit-risk balance of idelalisib in the authorised CLL indication, due to the added toxicity of bendamustine.
Estonian: Bendamustiini lisandunud toksilisuse tõttu peetakse uuringu -0123 tulemusi heakskiidetud CLL-i näidustusel idelalisiibi kasulikkuse ja riski tasakaalu hindamisel piiratuks.
English: Therefore while the relevance of these results are also limited for the authorised use in patients refractory to two prior lines of follicular lymphoma treatment, where idelalisib has been demonstrated to be effective and no other effective treatment options exist, they highlight the importance of minimising the risk of serious infection.
Estonian: Seetõttu rõhutatakse raske infektsiooni riski vähendamise tähtsust, kuigi nende tulemuste asjakohasus on samuti piiratud heakskiidetud kasutamisega patsientidel, kellele ei ole mõjunud follikulaarse lümfoomi kaks eelmist ravivalikut ja kellel idelalisiib on efektiivne ja muud ravivõimalused puuduvad.
English: This summary was last updated in 09-2015.
Estonian: Kokkuvõtte viimane uuendus: 09-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Menveo on 15 March 2010.
Estonian: Euroopa Komisjon andis Menveo müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 15. märtsil
English: This helps to enhance the immune response.
Estonian: See aitab tugevdada immuunvastust.
English: What measures are being taken to ensure the safe and effective use of Menveo?
Estonian: Mis meetmed võetakse, et tagada Menveo ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Menveo is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Menveo võimalikult ohutu kasutamine.
English: The full EPAR for Menveo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports .
Estonian: Euroopa avaliku hindamisaruande täistekst Menveo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports .
English: Other information about Menveo
Estonian: Muu teave Menveo kohta
English: Vaccination should be postponed in people who have a high fever.
Estonian: Vaktsineerimine tuleb edasi lükata patsientidel, kellel on kõrge palavik.
English: Menveo is a vaccine.
Estonian: Menveo on vaktsiin.
English: Menveo must not be given into a blood vessel or into or under the skin.
Estonian: Menveot ei tohi manustada veresoonde ega naha alla.
English: Why has Menveo been approved?
Estonian: Miks Menveo heaks kiideti?
English: The ability of Menveo to trigger the production of antibodies (immunogenicity) was assessed in a main study involving almost 4,000 participants aged 11 years and above and in a second main study involving almost 3,000 children between two and 10 years old.
Estonian: Menveo omadust tekitada antikehi (immunogeensust) uuriti ühes põhiuuringus, milles osales ligi 4000 vähemalt 11-aastast patsienti, ja teises põhiuuringus, milles osales ligi 3000 last vanuses 2-10 aastat.
English: What is the risk associated with Menveo?
Estonian: Mis riskid Menveoga kaasnevad?
English: What is Menveo?
Estonian: Mis on Menveo?
English: It contains parts of the bacterium Neisseria meningitidis (N. meningitidis).
Estonian: See sisaldab bakteri Neisseria meningitidis (N. meningitidis) osi.
English: In children between two and 10 years old, the most common side effects were similar and also included sleepiness and irritability.
Estonian: Kõige sagedamad kõrvalnähud 2-10-aastastel lastel olid sarnased, lisaks unisus ja ärrituvus.
English: Menveo is used in people who are at risk of exposure to the bacterium.
Estonian: Menveot kasutatakse inimestel, kellel on selle bakteriga kokkupuute risk.
English: For more information about treatment with Menveo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Menveoga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This document is a summary of the European Public Assessment Report (EPAR) for Menveo.
Estonian: See on vaktsiini Menveo Euroopa avaliku hindamisaruande kokkuvõte.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Menveo, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Menveo omaduste kokkuvõttesse ja pakendi infolehele vaktsiini ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Menveo meningococcal group A, C, W135 and Y conjugate vaccine
Estonian: Menveo meningokokkbakterite rühmade A, C, W135 ja Y konjugeeritud vaktsiin
English: For the full list of all side effects reported with Menveo, see the package leaflet.
Estonian: Menveo kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).
Estonian: Invasiivne haigus tekib, kui bakterid levivad kogu organismis, põhjustades raskeid infektsioone (nakkusi), näiteks meningiiti (ajukelmepõletik) ja sepsist (nakkusveresus).
English: The Committee therefore decided that Menveo's benefits are greater than its risks in people who are at risk of exposure to N. meningitidis bacterium, and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas seetõttu, et inimestel, kellel on bakteriga N. meningitidis kokkupuute risk, on Menveo kasulikkus suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
English: When the person is exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.
Estonian: Kui inimene puutub bakteriga kokku, hävitavad antikehad ja immuunsüsteemi teised osad bakteri ning aitavad kaitsta haiguse eest.
English: The vaccine must not be given to anyone who has had a life-threatening reaction to a vaccine that contains similar components in the past.
Estonian: Vaktsiini ei tohi manustada patsiendid, kellel on olnud eluohtlik reaktsioon sarnase koostisega vaktsiinile.
English: Menveo must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, including diphtheria toxoid.
Estonian: Menveot ei tohi kasutada patsiendid, kes on toimeaine või selle vaktsiini mis tahes muu koostisaine, sealhulgas difteeria toksoidi suhtes ülitundlikud (allergilised).
English: The CHMP noted that five N. meningitidis bacterial groups (A, B, C, W135 and Y) are responsible for invasive disease, and that Menveo provides broader protection than other available vaccines.
Estonian: Inimravimite komitee märkis, et bakteri N. meningitidis viis rühma (A, B, C, W135 ja Y) põhjustavad invasiivset haigust ning Menveo pakub suuremat kaitset kui muud turustatavad vaktsiinid.
English: Menveo is given as a single injection preferably into the shoulder muscle.
Estonian: Menveot manustatakse ühe süstena soovitatavalt õlalihasesse.
English: The most common side effects with Menveo in adults and children from the age of 11 (seen in more than 1 patient in 10) are headache, nausea (feeling sick), malaise (feeling unwell), myalgia (muscle pain), as well as pain, erythema (reddening of the skin) and induration (hardening) at the site of injection.
Estonian: Menveo kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) täiskasvanutel ja vähemalt 11-aastastel noorukitel on peavalu, iiveldus, halb enesetunne ja lihasevalu ning süstekoha valu, nahapunetus ja kõvenemine.
English: What benefit has Menveo shown during the studies?
Estonian: Milles seisneb uuringute põhjal Menveo kasulikkus?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Menveo.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas vaktsiini ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas vaktsiini kasutada.
English: The Committee noted that Menveo offers the benefits of conjugated vaccines, including producing a stronger immune response in young children.
Estonian: Inimravimite komitee märkis, et Menveol on konjugaatvaktsiinina eeliseid, näiteks tugevama immuunvastuse tekitamine väikelastel.
English: Menveo was compared with a similar conjugated vaccine against N. meningitidis.
Estonian: Menveot võrreldi bakteri N. meningitidis vastase sarnase konjugeeritud vaktsiiniga.
English: Menveo is used to protect adults and children from the age of two against invasive disease caused by four groups of the bacterium N. meningitidis (A, C, W135, and Y).
Estonian: Menveot kasutatakse täiskasvanute, noorukite ja vähemalt 2-aastaste laste kaitsmiseks bakteri N. meningitidis nelja rühma (A, C, W-135, ja Y) põhjustatud invasiivse haiguse eest.
English: How does Menveo work?
Estonian: Kuidas Menveo toimib?
English: How has Menveo been studied?
Estonian: Kuidas Menveot uuriti?
English: What is Menveo used for?
Estonian: Milleks Menveot kasutatakse?
English: How is Menveo used?
Estonian: Kuidas Menveot kasutatakse?
English: The number of people who had an immune response against the oligosaccharides was similar for the two vaccines.
Estonian: Mõlema vaktsiini korral tekkis immuunvastus oligosahhariidide vastu sarnasel arvul inimestel.
English: It is available as a powder and solution that are mixed together to make a solution for injection.
Estonian: Menveo on pulber ja lahus, millest segatakse kokku süstelahus.
English: The results of the main studies showed that Menveo was as effective as the comparator vaccine in stimulating an immune response against all four types of N. meningitidis oligosaccharides in adults and children from the age of two.
Estonian: Põhiuuringute tulemuste järgi tekitas Menveo täiskasvanutel ja vähemalt 2-aastastel lastel bakteri N. meningitidis kõigi nelja rühma oligosahhariidide vastu sama efektiivse immuunvastuse kui võrdlusvaktsiin.
English: The main measure of effectiveness was whether Menveo was as good as the comparator vaccine at stimulating immune response against the four types of N. meningitidis oligosaccharides.
Estonian: Efektiivsuse põhinäitaja oli Menveo omadus tekitada bakteri N. meningitidis nelja rühma oligosahhariidide vastu sama hea immuunvastus kui võrdlusvaktsiin.
English: Menveo contains small amounts of oligosaccharides (a type of sugar) extracted from four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified, then ‘conjugated' (attached) to a protein from the bacterium Corynebacterium diphtheriae.
Estonian: Menveo sisaldab vähesel hulgal oligosahhariide (suhkruliik), mis on eraldatud bakteri N. meningitidis neljast rühmast (A, C, W135 ja Y).
English: The vaccine can only be obtained with a prescription.
Estonian: Menveo on retseptivaktsiin.
English: The full EPAR for Lacosamide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ravimi Lacosamide Accord kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If treatment with Lacosamide Accord has to be stopped, the dose should be gradually reduced.
Estonian: Kui ravi ravimiga Lacosamide Accord tuleb katkestada, peab annust järk-järgult vähendama.
English: The usual starting dose is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines.
Estonian: Tavapärane algannus on 50 mg kaks korda ööpäevas, mida võidakse igal nädalal suurendada kuni suurima annuseni 300 mg kaks korda ööpäevas (kasutamisel ainsa ravimina) või 200 mg kaks korda ööpäevas (kasutamisel koos teiste epilepsiaravimitega).