FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Norvir on 26 August 1996.
Estonian: Euroopa Komisjon andis Norviri müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. augustil
English: What measures are being taken to ensure the safe and effective use of Norvir?
Estonian: Mis meetmed võetakse, et tagada Norviri ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Norvir is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Norviri võimalikult ohutu kasutamine.
English: The full EPAR for Norvir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Norviri kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Norvir
Estonian: Muu teave Norviri kohta
English: The standard dose for adults is 100 or 200 mg, once or twice a day.
Estonian: Täiskasvanute tavapärane annus on 100 või 200 mg üks või kaks korda ööpäevas.
English: It is available as an oral solution (80 mg/ml), as a powder for oral solution (100 mg sachets), as capsules (100 mg) and as tablets (100 mg).
Estonian: Seda turustatakse suukaudse lahusena (80 mg/ml), suukaudse lahuse pulbrina (100 mg kotikestes), kapslitena (100 mg) ja tablettidena (100 mg).
English: Norvir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Estonian: Norvir ei ravi HIV-nakkust ega AIDSi välja, kuid võib immuunsüsteemi kahjustumise ja AIDSiga seotud nakkuste ja haiguste tekke edasi lükata.
English: The recommended dose for adults (aged 18 years or over) is 600 mg twice a day.
Estonian: Täiskasvanute (vähemalt 18aastased) soovitatav annus on 600 mg kaks korda ööpäevas.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom sõltub kehapindalast (arvutatakse patsiendi pikkuse ja kaalu järgi).
English: The combination of Norvir and zidovudine was less effective than Norvir alone, although the reasons for this were unclear.
Estonian: Norviri kasutamine koos sidovudiiniga ei olnud nii efektiivne kui ainult Norviri kasutamine, kuigi selle põhjus oli ebaselge.
English: It should be taken with food.
Estonian: Norviri tuleb võtta koos toiduga.
English: The dose depends on which other protease inhibitor is being taken.
Estonian: Annus sõltub sellest, mis proteaasiinhibiitorit veel kasutatakse.
English: Norvir has been studied as an antiviral medicine in two main studies involving 1,446 patients.
Estonian: Norviri toimet viiruseravimina uuriti kahes põhiuuringus, milles osales 1446 patsienti.
English: When it is used as an HIV medicine, the most common side effects with Norvir (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), paraesthesia (unusual tingling sensations) around the mouth and in the limbs, headache, dizziness, peripheral neuropathy (damage to the nerves in the limbs), pharyngitis (sore throat), mouth and throat pain, cough, abdominal pain (stomach ache), nausea (feeling sick), diarrhoea, vomiting, dyspepsia (heartburn), pruritis (itching), rash, joint and back pain, tiredness, flushing and feeling hot.
Estonian: Kasutamisel HIV-ravimina on Norviri kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) düsgeusia (maitsehäired), paresteesia (ebatavaline kipitustunne) suu ümber ja jäsemetes, peavalu, peapööritus, perifeerne neuropaatia (jäsemete närvikahjustus), farüngiit (neelupõletik), suuja kurguvalu, köha, kõhuvalu, iiveldus, kõhulahtisus, oksendamine, düspepsia (kõrvetised), kihelus, lööve, liigese- ja seljavalu, väsimus, õhetus ja kuumatunne.
English: The CHMP decided that Norvir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Norviri kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: In the first study of Norvir as an antiviral medicine, 16% of the Norvir-treated patients (86 out of 543) experienced a worsening of disease or died, compared with 33% of the patients taking placebo (181 out of 547).
Estonian: Norviri kui viiruseravimi esimeses uuringus oli patsiente, kelle haigus süvenes või kes surid, Norviri uuringurühmas 16% (86 patsienti 543st) ja platseeborühmas 33% (181 patsienti 547st).
English: What is Norvir?
Estonian: Mis on Norvir?
English: Information on these studies can be found in the EPAR summaries for the other medicines.
Estonian: Nende uuringute teave on muude ravimite Euroopa avalike hindamisaruannete kokkuvõtetes.
English: Norvir is a medicine that contains the active substance ritonavir.
Estonian: Norvir on ravim, mis sisaldab toimeainena ritonaviiri.
English: For more information about treatment with Norvir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Norviriga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) and CD4 T cell levels in the blood (CD4 cell count).
Estonian: Efektiivsuse põhinäitaja oli HIV-sisalduse (viiruskoormus) ja CD4-T-rakkude sisalduse (CD4-rakkude sisaldus) muutus veres.
English: For the full list of all restrictions and side effects reported with Norvir, see the package leaflet.
Estonian: Norviri kohta teatatud piirangute ja kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Treatment with Norvir should be given by a doctor who has experience in the treatment of HIV infection.
Estonian: Ravi Norviriga peab läbi viima HIV-nakkuse ravis kogenud arst.
English: This is a summary of the European public assessment report (EPAR) for Norvir.
Estonian: See on ravimi Norvir Euroopa avaliku hindamisaruande kokkuvõte.
English: Norvir is used in combination with other HIV medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Estonian: Norviri kasutatakse koos teiste HI-viiruse ravimitega, et ravida üle 2-aastaseid patsiente, kellel on inimese I tüüpi immuunpuudulikkuse viiruse (HIV-1) nakkus.
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 Norvir.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: What is the risk associated with Norvir?
Estonian: Mis riskid Norviriga kaasnevad?
English: Why has Norvir been approved?
Estonian: Miks Norvir heaks kiideti?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Norvir, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Norviri omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Some medicines cannot be taken with Norvir when it is used in this way.
Estonian: Teatud ravimeid ei saa koos Norviriga kasutada.
English: Norvir must not be used in patients who have severe problems with their liver or patients who are taking St John's wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Norvir and are harmful at high levels in the blood.
Estonian: Ravimit ei tohi kasutada patsiendid, kellel on raske maksahaigus või kes kasutavad naistepuna (taimne depressiooniravim) või ravimeid, mis lagunevad organismis samalaadselt Norviriga ning mille liigne sisaldus veres on kahjulik.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down its rate of multiplication.
Estonian: Kui ensüüm on blokeeritud, ei paljune viirus normaalselt ning see aeglustab nakkuse levikut organismis.
English: At higher doses, ritonavir acts as a ‘protease inhibitor'.
Estonian: Suuremate annuste korral toimib ritonaviir proteaasiinhibiitorina.
English: This causes an increase of antiviral levels in the blood of such medicines and thus it boosts their antiviral activity.
Estonian: See suurendab nende viiruseravimite sisaldust veres ja ühtlasi ka nende viirusevastast toimet.
English: Norvir can be used as a ‘‘pharmacokinetic enhancer' (booster' to increase the blood levels of other antiviral medicines that belong to the same group as Norvir (protease inhibitors) called amprenavir, atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir and darunavir.
Estonian: Norviri tohib kasutada farmakokineetilise võimendina teiste Norviriga samasse rühma (proteaasiinhibiitorid) kuuluvate viiruseravimite, st amprenaviiri, atasanaviiri, fosamprenaviiri, lopinaviiri, sakvinaviiri, tipranaviiri ja darunaviiri sisalduse suurendamiseks veres.
English: In the second study, patients taking Norvir had greater reductions in viral load and increases in CD4 cell counts than those taking zidovudine alone.
Estonian: Teises uuringus vähenes Norviri kasutanud patsientidel viiruskoormus ja suurenes CD4-rakkude sisaldus rohkem kui ainult sidovudiini kasutanud patsientidel.
English: The second study compared Norvir taken alone, zidovudine (another antiviral medicine) taken alone and the combination of Norvir and zidovudine in 356 adults who had not taken treatment for HIV infection before.
Estonian: Teises uuringus võrreldi Norviri ja sidovuliini (samuti viiruseravim) kasutamist ainsa ravimina ning Norviri ja sidovudiini koos kasutamist 356 täiskasvanud patsiendil, kellel ei olnud HIV-nakkust varem ravitud.
English: Norvir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Estonian: Koos teiste viiruseravimitega manustatav Norvir vähendab HI-viiruse kogust veres ja hoiab selle sisalduse väikese.
English: How does Norvir work?
Estonian: Kuidas Norvir toimib?
English: When it is used as a booster, the side effects of Norvir depend on the other antiviral medicine being taken.
Estonian: Norviri kasutamisel võimendina sõltuvad Norviri kõrvalnähud teistest kasutatavatest viiruseravimitest.
English: What benefit has Norvir shown during the studies?
Estonian: Milles seisneb uuringute põhjal Norviri kasulikkus?
English: Norvir has been studied as a booster in clinical studies that were designed to assess the effects of the antiviral medicines that it is used to boost.
Estonian: Norviri toimet võimendina on uuritud toimet tugevdavate viiruseravimite toime hindamiseks kavandatud kliinilistes uuringutes.
English: Norvir can also be used as an HIV medicine, where it acts directly against the virus.
Estonian: Norviri tohib kasutada ka otsese viirusevastase toimega viiruseravimina.
English: Norvir, in combination with other antiviral medicines, also reduced viral loads in children.
Estonian: Norviri kasutamisel koos teiste viiruseravimitega vähenes viiruskoormus ka lastel.
English: When the active substance, ritonavir, acts as a ‘booster' it does so by slowing down the rate at which certain antiviral medicines given in combination with ritonavir are broken down in the body.
Estonian: Norviri toimeaine ritonaviir toimib võimendina, aeglustades koos ritonaviiriga manustatavate teatud viiruseravimite lagunemist organismis.
English: This means that it blocks a viral enzyme called protease, which is involved in the reproduction of HIV.
Estonian: Norvir blokeerib HI-viiruse paljunemisel osaleva viiruse ensüümi (proteaasi).
English: How is Norvir used?
Estonian: Kuidas Norviri kasutatakse?
English: How has Norvir been studied?
Estonian: Kuidas Norviri uuriti?
English: What is Norvir used for?
Estonian: Milleks Norviri kasutatakse?
English: See the package leaflet provided with the other medicine for full details.
Estonian: Üksikasjalik teave on teise ravimi pakendi infolehel.
English: The effects of Norvir as an antiviral medicine in combination with other antiviral medicines were also studied in four studies of children.
Estonian: Neljas laste uuringus uuriti ka Norviri kasutamist koos teiste viiruseravimitega.
English: The first compared Norvir with placebo (a dummy treatment) in 1,090 adults, as an add-on to the antiviral medicines the patients were already taking.
Estonian: Esimeses uuringus, milles osales 1090 täiskasvanud patsienti, võrreldi Norviri kasutamist lisaks teistele viiruseravimitele platseebo (näiva ravimi) kasutamisega.
English: EU/1/03/250/001 Ytracis
Estonian: EU/1/03/250/001
English: 1.850 GBq/ml Radiopharmaceutical precursor
Estonian: 1,850 GBq/ml Radiofarmatseutiline prekursor
English: Invented name Strength Pharmaceutical form
Estonian: Ravimpreparaadi nimetus
English: EU/1/18/1301/001
Estonian: EU/1/18/1301/001 Mepsevii
English: MA (EU) number (Invented)
Estonian: (Väljamõeldud) nimetus
English: The Board adopted the decision with two votes against.
Estonian: Haldusnõukogu võttis otsuse vastu kahe vastuhäälega.
English: The document should be agreed in two weeks' time.
Estonian: Kokkulepe dokumendi suhtes peaks saavutatama kahe nädala jooksul.
English: Therefore we cannot give our approval for current activities of Thomas Lönngren."
Estonian: Seetõttu ei saa me kiita heaks Thomas Lönngreni praegust tegevust.”
English: The reason for the delays will need to be clarified over time.
Estonian: Viivituste põhjus tuleb aja jooksul välja selgitada.
English: Meeting with Commissioner Dalli
Estonian: Kohtumine volinik Dalliga
English: Two new agencies joined the meeting.
Estonian: Koosolekutega liitus kaks uut asutust.
English: The report identified areas where some delays occurred.
Estonian: Aruandes loetleti valdkonnad, kus esines viivitusi.
English: The document follows the revised rules laid down by the European Commission.
Estonian: Dokumendis järgitakse Euroopa Komisjoni kehtestatud muudetud eeskirju.
English: The provisional draft budget (PDB) 2012 amounts to EUR 238.4 million, representing an increase of EUR 29.5 million over the 2011 budget.
Estonian: 2012. aasta esialgses eelarveprojekti järgi on eelarve 238,4 miljonit eurot, mis on 29,5 miljonit eurot rohkem kui 2011. aasta eelarves.
English: In the field of IT, a more strategic approach with clear prioritisation is called for.
Estonian: IT-valdkonnas nõutakse strateegilisemat ja selgete prioriteetidega lähenemisviisi.
English: The Acting Executive Director met with Commissioner Dalli on 11 March 2011.
Estonian: Tegevdirektori kohusetäitja kohtus volinik Dalliga 11. märtsil 2011.
English: The European Parliament Budget Control Committee received the proposal to postpone the discharge for the financial year 2009 for the Agency, although both the European Parliament Committee on the Environment, Public Health and Food Safety and the European Court of Auditors recommended the discharge.
Estonian: Euroopa Parlamendi eelarvekontrollikomisjonile laekus ettepanek lükata edasi heakskiidu andmine EMA 2009. aasta eelarve täitmisele, kuigi nii Euroopa Parlamendi keskkonna-, rahvatervise- ja toiduohutuse komisjon kui ka Euroopa Kontrollikoda soovitasid eelarve täitmise heaks kiita.
English: During the period from 25 November 2010 to 15 March 2011, the Board finalised eight written procedures.
Estonian: 25. novembrist 2010 15. märtsini 2011 valmis haldusnõukogul 8 kirjalikku menetlust.
English: [EMA/MB/19969/2011] The agenda was adopted.
Estonian: [EMA/MB/19969/2011] Päevakord võeti vastu.
English: The full annual report will be submitted to the Board in May 2011 for adoption at the June 2011 meeting.
Estonian: Täielik aastaaruanne esitatakse haldusnõukogule 2011. aasta mais ning see peaks vastu võetama 2011. aasta juuni koosolekul.
English: The European Commission drew the attention of the Board to the fact that the EU contribution is still under discussion in the Commission, and that any increase in budget or staff needs to be duly substantiated, particularly in crisis periods.
Estonian: Euroopa Komisjon juhtis haldusnõukogu tähelepanu asjaolule, et Euroopa Liidu toetus on komisjonis endiselt arutlusel ning et eelarve või töötajate arvu mis tahes suurendamine peab olema nõuetekohaselt põhjendatud, eriti kriisiperioodidel.
English: However, the Agency expects that the Budgetary Authority will grant some posts later this year.
Estonian: EMA loodab siiski, et eelarvepädev institutsioon lubab luua mõne ametikoha käesoleval aastal hiljem.
English: The Board was also informed that the Agency is reviewing the efficiency of its procedures and is introducing changes in other areas where savings can be made.
Estonian: Samuti teatati haldusnõukogule, et EMA vaatab läbi oma menetluste tõhususe ja teeb muudatusi muudes valdkondades, kus on võimalik saavutada kokkuhoidu.
English: This may be due to the decrease in the number of applications and to fluctuations in submission of applications during the year.
Estonian: Selle põhjuseks võib olla taotluste arvu vähenemine ja taotluste ebaühtlane esitamine aasta jooksul.
English: Information on the Agency's cooperation with the World Organisation for Animal Health (OIE) will also be added.
Estonian: Samuti lisatakse tööprogrammi teave EMA ja Maailma Loomatervishoiu Organisatsiooni (OIE) vahelise koostöö kohta.
English: Agenda for 17 March 2011 meeting
Estonian: 17. märtsi 2011 koosoleku päevakord
English: With regard to the structural problems of the budget, Commissioner Dalli was of the opinion that the Agency should be allowed to retain the surplus revenue from fees.
Estonian: Eelarve struktuursete probleemide küsimuses leidis volinik Dalli, et EMA peaks saama jätta endale lõivudest saadava tulu ülejäägi.
English: The Board noted that the number of new chemical entities and the number of opinions were lower than those received in the previous three years.
Estonian: Haldusnõukogu märkis, et uute keemiliste ühendite ja arvamuste arv oli eelmise kolme aastaga võrreldes väiksem.
English: There has been a significant increase in the numbers of paediatric procedures (around 20% higher than in 2009) and inspections (a 30% increase), and a very high increase in veterinary scientific advice applications (21 applications received, which is a 90% increase).
Estonian: Märkimisväärselt suurenes pediaatriliste menetluste arv (see oli ligikaudu 20% suurem kui 2009. aastal), samuti kontrollkäikude arv (30% rohkem) ning veterinaaria teadusliku nõustamise taotluste arv (laekus 21 avaldust ehk 90% rohkem).
English: • The meeting with the European Commission to discuss principles of a future fee regulation (including the issue of non-remunerated tasks).
Estonian: • kohtumine Euroopa Komisjoniga, et arutada tulevase lõivude määruse põhimõtteid (sh tasustamata ülesannete küsimust);
English: With regard to the staffing for 2011, the Commissioner indicated that the Agency may receive some of the posts requested for 2011.
Estonian: 2011. aasta personalivajaduste kohta märkis volinik, et EMA võib saada osa 2011. aastaks taotletud ametikohtadest.
English: Request of the former Executive Director for authorisation of external activities after leaving the service
Estonian: Endise tegevdirektori taotlus lubada tal tegelda pärast teenistusest lahkumist muu tegevusega
English: It was also agreed that chairs may ask for the possibility to sit as observers in the meetings of the boards of other agencies.
Estonian: Samuti lepiti kokku, et eesistujad võivad paluda luba osaleda vaatlejatena teiste asutuste haldusnõukogude koosolekutel.
English: 22 March 2011
Estonian: 22. märts 2011
English: • The task force on the availability of medicines, which has completed its mandate.
Estonian: • ravimite kättesaadavuse rakkerühm, mille volitused on lõppenud;
English: • The public consultation on the Transparency Directive (a proposal for the review of the Directive may be made by the end of 2011).
Estonian: • avalik arutelu läbipaistvusdirektiivi teemal (direktiivi läbivaatamise ettepanek võidakse teha 2011. aasta lõpuks).
English: The Board stressed its role in protecting the public interest and the reputation of the Agency.
Estonian: Haldusnõukogu rõhutas oma rolli avalike huvide ja EMA maine kaitsmisel.
English: Discharge
Estonian: Heakskiidu andmine
English: Any budgetary requirements concerning the implementation of the pharmacovigilance legislation were only provisionally adopted, and need to be made fully plausible in the following months.
Estonian: Ravimiohutuse järelevalve õigusaktide rakendamisega seotud eelarvenõuded võeti vastu üksnes ajutiselt ning need tuleb täielikult kinnitada lähikuudel.
English: The Agency has not received new posts for 2011 and has difficulty recruiting scientific staff as contract agents, due to the short term of the contracts and lower remuneration level.
Estonian: EMA ei ole saanud uusi ametikohti 2011. aastaks ja probleeme on teadustöötajate värbamisel lepinguliste töötajatena, sest lepingute tähtajad on lühikesed ja tasu väiksem.
English: The Board indicated that it expects the next Executive Director to inform it of their intentions before the end of their mandate.
Estonian: Haldusnõukogu märkis, et loodetavasti teatab järgmine tegevdirektor oma kavatsustest enne oma volituste lõppu.
English: Work programme and preliminary draft budget 2012
Estonian: Tööprogramm ja 2012. aasta esialgne eelarveprojekt
English: The two-day meeting of the Management Board of the European Medicines Agency (EMA) started on 16 March 2011 with presentations and an exchange of views on the following topics:
Estonian: Euroopa Ravimiameti (EMA) haldusnõukogu kahepäevane koosolek algas 16. märtsil 2011 esitlustega ja seisukohtade vahetamisega järgmistel teemadel:
English: The Agency will provide national competent authorities with individual line listings to enable them to review their own performance.
Estonian: EMA annab riikide pädevatele asutustele individuaalsed loetelud, millega need saavad kontrollida enda tulemuslikkust.
English: • The legislative proposal on information to patients (the discussions will restart at the Council level).
Estonian: • patsienditeabe õigusaktide vastuvõtmise ettepanek (arutelud algavad taas nõukogu tasandil);
English: The Board adopted the establishment plan of 612 posts, which represents an increase of 45 posts required for the preparation and implementation of the pharmacovigilance legislation.
Estonian: Haldusnõukogu võttis vastu 612 ametikohast koosneva ametikohtade loetelu - see tähendab 45 uut ametikohta, mida on vaja ravimiohutuse järelevalve õigusaktide ettevalmistamiseks ja rakendamiseks.
English: The Board concluded that none of the activities as communicated presented a conflict of interests.
Estonian: Haldusnõukogu leidis, et ühegi teatatud tegevusega ei kaasne huvide konflikti.
English: • The progress on the five calls within the process on corporate responsibility in the field of pharmaceuticals: coordinated access to orphan medicinal products, capacity building on contractual agreements for innovative medicines, market access for biosimilars, facilitating supply in small markets and promoting a good governance for non-prescription medicines.
Estonian: • farmaatsiatoodete valdkonna ettevõttevastutuse protsessi viie eesmärgi tegevus: kooskõlastatud juurdepääs harvikravimitele, suutlikkuse suurendamine innovatiivsete ravimite lepingute korral, bioloogiliselt sarnaste ravimite turulepääs, väikeste turgude tarne soodustamine ning hea juhtimistava edendamine käsimüügiravimite valdkonnas;
English: The revised procedure now foresees that unless five or more members expressed their reservations with regards to the nomination, the candidate is considered accepted and the procedure is closed.
Estonian: Muudetud menetlusega nähakse ette, et kui uue liikme suhtes ei väljenda kahtlusi vähemalt viis liiget, loetakse kandidaat heakskiidetuks ja menetlus lõpetatakse.