FrancophonIA/ELRC3.0 huggingface dataset:
English: t may request a the opinion within 15 days of receipt of notification of this negative opinion.
Estonian: Taotleja taotles arvamuse läbivaatamist.
English: In November 2008, the CHMP gave a positive opinion on Zeftera, recomm marketing authorisatio study sites by the Food and Drug Administration (FDA) in the United States of A concerns over the way the main clinical studies were conducted.
Estonian: 2008. aasta novembris andis inimravimite komitee Zeftera kohta positiivse arvamuse, soovitades anda selle müügiloa.
English: ending that it be granted n. However, the Committee later received information about an inspection of merica that identified requested ile further compliance with sites.
Estonian: Hiljem sai komitee aga teavet USA Toidu- ja Ravimiameti (FDA) inspektsiooni kohta uuringukeskustes USAs, mille alusel komitee peatas ravimi müügiloa andmise protsessi.
English: Although the study results suggested that the medicine was ttee e medicine should
Estonian: Vaatamata sellele, et uuringutulemuste põhjal oli ravim patsientidele kasulik, väljendas inimravimite komitee kahtlust tulemuste usaldusväärsuse suhtes.
English: Zeftera was expected to be used to treat adults with complicated infections of th other conditions tha
Estonian: Enne inimuuringuid kontrolliti Zeftera toimet muude katsetega.
English: Zeftera is a powder that is made up into a solution f substance ceftobiprole.
Estonian: Zeftera sisaldab toimeainena tseftobiprooli.
English: The full EPAR for Levetiracetam ratiopharm 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 Levetiracetam ratiopharm kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as oblong tablets (250 mg, 500 mg, 750 mg and 1000 mg) and as an oral solution (100 mg/ml).
Estonian: Seda turustatakse piklike tablettidena (250 mg, 500 mg, 750 mg ja 1000 mg) ja suukaudse lahusena (100 mg/ml).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam ratiopharm on 26 August 2011.
Estonian: Euroopa Komisjon andis ravimi Levetiracetam ratiopharm müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 26. augustil 2011.
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Estonian: • primaarsed generaliseerunud toonilised-kloonilisied episoodid (rasked epilepsiaepisoodid, millega kaasneb ka teadvusekaotus) vähemalt 12-aastastel patsientidel, kellel on idiopaatiline generaliseerunud epilepsia (epilepsia liik, mille tekkepõhjust peetakse geneetiliseks).
English: The oral solution may be mixed in a glass of water before it is taken.
Estonian: Suukaudse lahuse võib segada enne manustamist klaasi veega.
English: For more information about treatment with Levetiracetam ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Levetiracetam ratiopharmi ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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 Levetiracetam ratiopharm.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The oral solution is recommended when starting treatment in children under six years old or weighing less than 25 kg.
Estonian: Suukaudset lahust soovitatakse kasutada alla 6aastaste või alla 25 kg kehamassiga laste ravi alustamisel.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam ratiopharm.
Estonian: Käesolev dokument on ravimi Levetiracetam ratiopharm Euroopa avaliku hindamisaruande kokkuvõte.
English: This helps Levetiracetam ratiopharm to stabilise electrical activity in the brain and prevent seizures.
Estonian: Sekkumine aitab ravimil stabiliseerida aju elektrilist talitlust ja ennetada krampe.
English: This can be increased up to 21 mg/kg twice a day.
Estonian: Annust tohib suurendada annuseni 21 mg/kg kohta kaks korda ööpäevas.
English: Because Levetiracetam ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Levetiracetam ratiopharm on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Levetiracetam ratiopharm can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Estonian: Ravimit Levetiracetam ratiopharm tohib kasutada ainsa ravimina vähemalt 16-aastastel patsientidel, kellel on äsja diagnoositud epilepsia, et ravida sekundaarse generalisatsiooniga või sekundaarse generalisatsioonita partsiaalseid episoode.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam ratiopharm has been shown to have comparable quality and to be bioequivalent to Keppra.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Levetiracetam ratiopharm võrdväärne kvaliteet ja bioekvivalentsus ravimiga Keppra.
English: This means that Levetiracetam ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Estonian: See tähendab, et Levetiracetam ratiopharm on sarnane võrdlusravimiga Keppra, millel juba on Euroopa Liidus müügiluba.
English: Levetiracetam ratiopharm can also be used as an add-on to other anti-epileptic medicines to treat:
Estonian: Ravimit Levetiracetam ratiopharm võib kasutada ka teiste epilepsiaravimite lisaravimina, et ravida järgmisi haigusseisundeid:
English: Other information about Levetiracetam ratiopharm
Estonian: Muu teave Levetiracetam ratiopharmi kohta
English: When Levetiracetam ratiopharm is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Estonian: Ravimi Levetiracetam ratiopharm lisamisel teisele epilepsiaravimile vähemalt 12-aastastel patsientidel kehamassiga üle 50 kg on algannus 500 mg kaks korda ööpäevas.
English: Levetiracetam ratiopharm tablets are swallowed with liquid.
Estonian: Levetiracetam ratiopharmi tabletid neelatakse alla koos vedelikuga.
English: Because Levetiracetam ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Estonian: Et Levetiracetam ratiopharm on geneeriline ravim, piirdusid uuringud katsetega, milles näidati ravimi Levetiracetam ratiopharm bioekvivalentsust võrdlusravimiga Keppra.
English: When Levetiracetam ratiopharm is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Estonian: Ravimi Levetiracetam ratiopharm kasutamisel ainsa ravimina on algannus 250 mg kaks korda ööpäevas, seda suurendatakse kahe nädala pärast 500 mg-ni kaks korda ööpäevas.
English: Levetiracetam ratiopharm is a medicine that contains the active substance levetiracetam.
Estonian: Levetiracetam ratiopharm on ravim, mis sisaldab toimeainena levetiratsetaami.
English: Why has Levetiracetam ratiopharm been approved?
Estonian: Miks Levetiracetam ratiopharm heaks kiideti?
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1500 mg twice a day.
Estonian: Olenevalt patsiendi ravivastusest võib annust kahenädalase intervalliga suurendada kuni maksimaalse annuseni 1500 mg kaks korda ööpäevas.
English: Levetiracetam ratiopharm is a ‘generic medicine'.
Estonian: Levetiracetam ratiopharm on geneeriline ravim.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Keppra korral ületab ravimi Levetiracetam ratiopharm kasulikkus sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: What is Levetiracetam ratiopharm?
Estonian: Mis on Levetiracetam ratiopharm?
English: The active substance in Levetiracetam ratiopharm, levetiracetam, is an anti-epileptic medicine.
Estonian: Ravimi Levetiracetam ratiopharm toimeaine levetiratsetaam on epilepsiaravim.
English: How is Levetiracetam ratiopharm used?
Estonian: Kuidas Levetiracetam ratiopharmi kasutatakse?
English: What are the benefits and risks of Levetiracetam ratiopharm?
Estonian: Milles seisneb Levetiracetam ratiopharmi kasulikkus ja mis riskid ravimiga kaasnevad?
English: What is Levetiracetam ratiopharm used for?
Estonian: Milleks Levetiracetam ratiopharmi kasutatakse?
English: How has Levetiracetam ratiopharm been studied?
Estonian: Kuidas Levetiracetam ratiopharmi uuriti?
English: How does Levetiracetam ratiopharm work?
Estonian: Kuidas Levetiracetam ratiopharm toimib?
English: This commitment is reflected in the Agency's work programme and budget.
Estonian: Seda kohustust kajastab ka ameti tööprogramm ja eelarve.
English: As a result, the Agency has grown into a complex organisation that is heavily dependent on effective and efficient information and communication technologies.
Estonian: Selle tulemusel on amet muutunud keeruliseks organisatsiooniks, olles suures sõltuvuses efektiivsest ja tõhusast info- ja sidetehnoloogiast.
English: This will constitute a significant part of the Agency's contribution to the new Community Animal Health Strategy, ‘Prevention is better than cure'.
Estonian: See moodustab märkimisväärse osa ameti panusest ühenduse uude loomatervise strateegiasse „Haiguste ennetamine on parem kui ravi”.
English: Safety-monitoring of medicines is an area that is continuously being scrutinised, developed and strengthened.
Estonian: Ravimiohutuse jälgimine on valdkond, mida pidevalt uuritakse, arendatakse ja tugevdatakse.
English: In addition, the year 2008 saw some quality issues with products whose active ingredients were manufactured outside the EU.
Estonian: 2008. aastal kogesime ka teatud kvaliteediprobleeme neil ravimitel, mille toimeained olid toodetud väljaspool Euroopa Liitu.
English: The Agency has been, and will continue to be, heavily involved in activities that support innovation and improve availability of medicines.
Estonian: Ravimiamet on ja jääb tihedalt kaasatuks tegevustesse, mis toetavad uuendusi ja parandavad ravimite kättesaadavust.
English: This work is being carried out both in internal fora and within the framework of the Innovative Medicines Initiative.
Estonian: Seda tööd tehakse nii sisefoorumite kaudu kui ka uuenduslike ravimite algatuse raames.
English: As can be seen from this work programme, activities in the field of recently implemented legislation on paediatric medicines remain complex and dynamic.
Estonian: Käesolevast tööprogrammist nähtub, et tegevus hiljuti kohaldatud pediaatriliste ravimite õigusaktide vallas jääb keeruliseks ja dünaamiliseks.
English: It is expected that the latter two pieces of legislation will come into effect during 2009.
Estonian: Viimati nimetatud kahe valdkonna õigusaktid jõustuvad arvatavasti 2009. aastal.
English: contributing to an environment that stimulates innovation.
Estonian: uuendust stimuleeriva keskkonna arendamine.
English: Preparatory work has been undertaken in 2008, and the Agency should be in a position to start commissioning pharmacoepidemiological studies in 2009.
Estonian: Ettevalmistustööd algasid 2008. aastal ning 2009. aastal peaks amet olema valmis tellima farmakoepidemioloogilisi uuringuid.
English: strengthening the European medicines network;
Estonian: Euroopa ravimivõrgustiku tugevdamine;
English: The European medicines network is vital to the Agency's ability to deliver on its public-health mission and objectives.
Estonian: Euroopa ravimivõrgustik on ülimalt tähtis ameti suutlikkuse jaoks täita oma rahvatervise missiooni ja ülesandeid.
English: The EMEA, together with its partners, has developed and is implementing the European risk-management strategy (ERMS).
Estonian: EMEA on koos oma partneritega töötanud välja ja rakendab Euroopa riskijuhtimisstrateegiat.
English: The Agency has been implementing various new parts of the pharmaceutical legislation over the course of a number of years.
Estonian: Amet on aastate jooksul kohaldanud uusi ravimeid käsitlevate õigusaktide mitmeid uusi osi.
English: fostering transparency, communication and provision of information;
Estonian: läbipaistvuse, suhtluse ja teabepakkumise edendamine;
English: Both initiatives attempt to improve medicinal product development processes and, therefore, are of importance to the Agency.
Estonian: Mõlema algatuse abil püütakse täiustada ravimite väljatöötamise protsesse, mistõttu on algatused ametile tähtsad.
English: At the same time, the EMEA has been allocating a significant part of its IT development and maintenance resources to the development and support of the EU Telematics systems.
Estonian: Samal ajal on EMEA pööranud palju tähelepanu oma IT-valdkonna arengu- ja hoolduse ressurssidele, et arendada ja toetada ELi telemaatikasüsteeme.
English: The Agency will continue to focus on further streamlining these activities, including the development of a paediatric research network.
Estonian: Amet keskendub edaspidigi nende tegevuste ühtlustamisele, sealhulgas pediaatriliste uuringute võrgustiku arendamisele.
English: The Agency's work programme is shaped by a number of trends, scientific, political and other developments that will dominate the Agency's environment in 2009.
Estonian: Ravimiameti tööprogrammi kujundavad mitmed suunad ning teaduslikud, poliitilised ja muud arengud, mis on 2009. aastal ameti olustikus tähtsal kohal.
English: Significant effort is being made in the areas of communication, transparency and provision of information.
Estonian: Suhtluse, läbipaistvuse ja teabepakkumise valdkondades tehakse märkimisväärseid jõupingutusi.
English: Some of these objectives include improving the planning of scientific resources, progressing initiatives in the field of training and competence development, and assuring effective communication within the network.
Estonian: Mõned neist eesmärkidest sisaldavad teadusressursside paremat planeerimist, koolituse ja pädevuse arendamise algatuste edendamist ning võrgusisese tõhusa suhtlemise tagamist.
English: The Agency operates in a global regulatory environment that is characterised, among other trends, by an increasing number of clinical trials conducted in countries where it is perceived that the application of good clinical practice does not yet have traditions as well established as those in the European Union, the US and other developed countries.
Estonian: Ravimiamet toimib globaalses regulatiivses keskkonnas, mida muude suundumuste hulgas iseloomustab üha kasvav hulk kliinilisi katseid, mida viiakse läbi riikides, kus hea kliiniline tava ei ole veel nii juurdunud kui Euroopa Liidus, Ameerika Ühendriikides ja teistes arenenud riikides.
English: This will have an effect on the workload in the field of inspections, both for the EMEA and for the national competent authorities, and will add a new dimension to the EMEA's international commitments.
Estonian: See omakorda mõjutab inspekteerimise töökoormust nii EMEAs kui ka liikmesriikide pädevates asutustes ning annab EMEA rahvusvahelistele kohustustele uue mõõtme.
English: The EMEA remains committed to improving the availability of veterinary medicines, and will focus its efforts in three major areas to achieve this.
Estonian: Euroopa Ravimiamet jätkab ka veterinaarravimite kättesaadavuse parandamist ning keskendab sel eesmärgil oma jõupingutused kolmele põhivaldkonnale.
English: further improving the effectiveness and efficiency of the Agency's core activities, including consolidation of the EMEA's international strategy in the light of global challenges;
Estonian: ameti põhitegevuse efektiivsuse ja tõhususe edasine täiustamine, sealhulgas ameti rahvusvahelise strateegia kindlustamine, pöörates tähelepanu üleilmsetele probleemidele;
English: The results of various process-improvement initiatives, process analyses and staff surveys show that it is now time for the Agency to refocus some of its IT resources on improving corporate information systems as a step towards a fully electronic working environment.
Estonian: Paljude protsessitäiustamise algatuste, protsessianalüüside ja personaliuuringute tulemused näitavad, et nüüd on vaja ametil hakata rohkem tähelepanu pöörama oma IT-ressurssidele, täiustades organisatsiooni infosüsteeme, mis on samm edasi täisdigitaalse töökeskkonna loomise suunas.
English: This will also facilitate the Agency's plans to provide access to safety and clinical trial-related information.
Estonian: See lihtsustab ka ameti plaane pakkuda juurdepääsu ohutusja kliiniliste katsete teabele.
English: The Agency's priorities have been set considering these and other factors affecting the Agency in 2009, and will centre around:
Estonian: Ameti prioriteete sõnastades on neid ja teisi 2009. aastal ametit mõjutavaid tegureid arvesse võetud ning esikohale asetuvad järgmised teemad:
English: An important part of the ERMS is the implementation of the European Network of Centres for Pharmacovigilance and Pharmacoepidemiology (ENCePP).
Estonian: Riskijuhtimisstrateegia tähtsa osa moodustab Euroopa ravimiohutuse järelevalve ja farmakoepidemioloogia Euroopa keskuste võrgustiku (ENCePP) rakendamine.
English: Third, the Agency will actively contribute to the work of the EU Commission, Community agencies and national competent authorities in relation to the assessment and, where appropriate, management of the potential risk to man arising from the use of antimicrobial agents as veterinary medicinal products.
Estonian: Kolmandaks võtab amet aktiivselt osa Euroopa Liidu Komisjoni, ühenduse ametite ja riiklike pädevate asutuste tööst, mis on seotud mikroobivastaste veterinaarravimite kasutamisest inimtervisele tekkida võiva riski hindamise ja vajaduse korral juhtimisega.
English: These developments include recently adopted and upcoming legislation vesting the Agency with new responsibilities, including legislation on advanced-therapy medicinal products, a revised regulation on variations to marketing authorisations and revised legislation on safe limits for residues of veterinary medicines in food.
Estonian: Nimetatud arengud hõlmavad ka hiljuti vastu võetud ja tulevasi õigusakte, milles antakse ametile uued kohustused, sealhulgas uudsete ravimeetodite ravimite õigusaktid, müügilubade muutmisi käsitlev muudetud määrus ja toidus sisalduvate veterinaarravimite jääkide piirnorme käsitlevad muudetud õigusaktid.
English: Another important project is the strengthening of the methodology for assessment of the benefit-risk balance of human and veterinary medicines throughout their lifespan.
Estonian: Teine tähtis projekt on tugevdada metodoloogiat, millega hinnatakse inim- ja veterinaarravimite kasulikkust ja riski ravimi kogu kasutustsükli kestel.
English: This year, the Agency will further support collaboration within the network and benchmarking activities (BEMA1), and will provide input into efforts aimed at strengthening the capacity of the network.
Estonian: Käesoleval aastal jätkab amet võrgustikusisese ja võrdlustegevuste1 toetamist, samuti tehakse jõupingutusi võrgustiku jõudluse tugevdamiseks.
English: Additionally, following internal preparatory work and consultation, the EMEA will adjust its organisational structure to enable the Agency to deliver on its mission in a more effective and efficient way.
Estonian: Peale selle kohaldab ravimiamet pärast asutusesisest ettevalmistamist ja nõupidamisi oma organisatsioonistruktuuri, et võimaldada ametil oma missiooni efektiivsemalt ja tõhusamalt ellu viia.
English: In the field of innovation, the EMEA will dedicate its efforts and resources to the work of the Innovative Medicines Initiative and the European Technology Platform for Global Animal Health.
Estonian: Uuenduste valdkonnas suunab Euroopa Ravimiamet oma jõupingutused ja ressursid uuenduslike ravimite algatusele ja üleilmse loomatervise Euroopa tehnoloogia platvormile.
English: As a result, the Agency will re-launch its website towards the end of 2009, and will begin work to ensure that all public-facing websites managed by the Agency are easy to use and access by external stakeholders.
Estonian: Seetõttu avaldab ravimiamet 2009. aasta lõpu poole uuendatud veebilehe ning asub tööle selles suunas, et ameti avalikud veebilehed oleksid välistele sidusrühmadele kergesti kasutatavad ja kättesaadavad.
English: As scientists from European and other countries work in the area of biomarkers, translational medicine and nanotechnologies, the EMEA will provide scientific input into these novel fields of medicinal product development.
Estonian: Euroopa ja teiste riikide teadlased teevad uurimusi biomarkerite, translatsioonimeditsiini ja nanotehnoloogia alal ning Euroopa Ravimiamet annab nendesse uudsetesse ravimiarenduse valdkondadesse oma teadusliku panuse.
English: implementing and operating the new legislation on advanced-therapy medicinal products for human use, as well as other new legislation;
Estonian: uudsete ravimeetodite inimravimeid käsitlevate ja ka muude uute õigusaktide kohaldamine ja rakendamine;
English: Having established the necessary procedures for the evaluation of applications and for the provision of other specific advice related to advanced-therapy medicinal products, the Agency will operate these procedures and will develop riskmanagement and pharmacovigilance activities in this new field of responsibility.
Estonian: Olles loonud vajalikud menetlused uudsete ravimeetodite ravimitega seotud taotluste hindamiseks ja muude erinõuannete pakkumiseks, hakkab ravimiamet neid menetlusi nüüd rakendama, aga ka arendama uues vastutusvaldkonnas riskijuhtimist ja ravimijärelevalvet.
English: First, the Agency will work with stakeholders to promote and facilitate authorisation through the centralised procedure of vaccines against major epizootic diseases of animals, particularly avian influenza, bluetongue and foot-and-mouth disease.
Estonian: Esiteks hakkab amet koos oma sidusrühmadega edendama ja lihtsustama loomade põhiliste episootiliste haiguste (eelkõige linnugripi, lammaste katarraalse palaviku ja suu- ja sõrataudi) vastaste vaktsiinide heakskiitmist tsentraliseeritud menetluse korras.
English: continuing to improve the safety-monitoring of medicines for human and veterinary use;
Estonian: inim- ja veterinaarravimite ohutuse jälgimise jätkuv täiustamine;
English: The Agency is experiencing continuing growth in the volume of work across various areas of its activities, including scientific advice, medicines for paediatric use, authorisation of vaccines against epidemic diseases of animals, transparency and international commitments, to name but a few.
Estonian: Jätkuvalt on kasvanud ameti töömaht mitmesugustes tegevusvaldkondades, sealhulgas teadusnõustamises, pediaatrilise kasutusega ravimite, epideemiliste loomahaiguste vastaste vaktsiinide ning läbipaistvuse ja rahvusvaheliste kohustuste valdkonnas, mis moodustavad vaid osa kogu tööst.
English: contributing to improved availability of medicines for human and veterinary use;
Estonian: inim- ja veterinaarravimite parema kättesaadavuse tagamine;
English: Second, the Agency will implement initiatives, in cooperation with the network, aimed at facilitating greater availability of veterinary medicines indicated for limited markets, including minor use/minor species, through the introduction of measures to assist companies at the time of authorisation.
Estonian: Teiseks rakendab amet koostöös oma võrgustikuga algatusi, mille eesmärk on muuta piiratud turuga, sealhulgas väiksemas mahus kasutatavad ja vähemlevinud liikide veterinaarravimid hõlpsamini kättesaadavaks.