FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 24 weeks of treatment.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide osakaal, kelle ACR-skoorid (valusate, turses liigeste ja muude sümptomite mõõdikud) vähenesid pärast 24-nädalast ravi vähemalt 20%.
English: Benepali is not for use in children weighing less than 62.5 kg, as Benepali does not have low-dose formulations.
Estonian: Benepali ei ole ette nähtud kasutamiseks alla 62,5 kg kaaluvatel lastel ja noorukitel, sest Benepalil puuduvad väikese annusega ravimvormid.
English: Why is Benepali approved?
Estonian: Miks Benepali heaks kiideti?
English: It is not intended to provide practical advice on how to use Benepali.
Estonian: Hindamisaruandes ei anta Benepali kasutamise praktilisi nõuandeid.
English: Patients who take Benepali must be given the special alert card that summarises important safety information about the medicine so they can recognise any serious side effects and know when to seek urgent attention from their doctor.
Estonian: Benepalit võtvatele patsientidele tuleb anda spetsiaalne hoiatuskaart, millel on ravimi kokkuvõtlik ohutusteave, et nad tunneksid ära rasked kõrvalnähud ning teaksid, millal on vaja viivitamatult arsti poole pöörduda.
English: 78% of patients given Benepali (193 out of 247) achieved at least a 20% reduction in ACR scores after 24 weeks of treatment, compared with 80% of patients given Enbrel (188 out of 234).
Estonian: Uuringu tulemused näitasid, et Benepali vähendas reumatoidartriidi sümptomeid sama efektiivselt kui Enbrel: patsiente, kelle ACR-skoorid vähenesid pärast 24-nädalast ravi vähemalt 20%, oli Benepalit kasutanute seas 78% (193 patsienti 247st) ja Enbreli kasutanute seas 80% (188 patsienti 234st).
English: Because Benepali is a biosimilar medicine, all the studies on effectiveness and safety of etanercept carried out with Enbrel do not need to be repeated for Benepali.
Estonian: Et Benepali on bioloogiliselt sarnane ravim, ei pea Enbreliga tehtud etanertsepti efektiivsuse ja ohutuse uuringuid Benepali puhul kordama.
English: Benepali can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before;
Estonian: Benepalit tohib kasutada ka raske reumatoidartriidiga patsientidel, kes ei ole varem metotreksaati võtnud.
English: • psoriatic arthritis in adults who have not responded adequately to other treatments;
Estonian: • Psoriaatiline artriit täiskasvanutel, kellel ei ole muu raviga tekkinud piisavat ravivastust.
English: In addition, a study comparing Benepali to Enbrel in adults with rheumatoid arthritis showed that both medicines are similarly effective.
Estonian: Lisaks selgus reumatoidartriidiga täiskasvanutel tehtud Benepali ja Enbreli võrdlusuuringust, et mõlemad ravimid on ühtviisi efektiivsed.
English: The company that makes Benepali will provide educational material for doctors expected to prescribe the product (to teach patients how to use the pre-filled syringe/pen correctly).
Estonian: Benepali tootja annab ravimit eeldatavasti määravatele arstidele teabematerjali, et nad selgitaksid patsientidele, kuidas kasutada eeltäidetud süstlaid/pensüstlaid õigesti.
English: Benepali is used either in combination with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient.
Estonian: Benepalit kasutatakse koos metotreksaadiga (immuunsüsteemi mõjutav ravim) mõõduka või raske haigusega täiskasvanutel, kellel ei ole muu raviga tekkinud piisavat ravivastust, või ainsa ravimina, kui metotreksaat ei sobi.
English: Benepali is used in patients who have not responded to or cannot receive other treatments for this disease.
Estonian: Benepalit kasutatakse patsientidel, kellel ei ole selle haiguse muu raviga tekkinud ravivastust või kes muud ravi ei talu.
English: • certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of joints) in the following groups:
Estonian: • Lapseea idiopaatilise artriidi (haruldane lapseea haigus, mis põhjustab liigesepõletikku) teatud vormid järgmistel patsiendirühmadel:
English: Thus, all these data were considered sufficient to conclude that Benepali will behave in the same way in terms of effectiveness in adults as in children in Benepali's approved indications.
Estonian: Nende piisavate andmete põhjal tehti järeldus, et Benepali on heakskiidetud näidustustel nii täiskasvanutel kui ka lastel võrdselt efektiivne.
English: Patients developing a serious infection should stop Benepali treatment.
Estonian: Raske infektsiooni tekkimisel tuleb ravi Benepaliga katkestada.
English: • severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray;
Estonian: • Radioloogilise tõendita raske aksiaalne spondüloartriit (lülisamba krooniline põletikuline haigus), kui esinevad objektiivsed põletikunähud, kuid röntgenuuring ei näita kõrvalekaldeid.
English: For practical information about using Benepali, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Benepali kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The active substance in Benepali, etanercept, is a protein designed to block the activity of a protein in the body called tumour necrosis factor (TNF).
Estonian: Benepali toimeaine etanertsept on valk, mis blokeerib organismis kasvaja nekroositeguriks (TNF) nimetatava valgu toime.
English: The reference medicine for Benepali is Enbrel.
Estonian: Benepali võrdlusravim on Enbrel.
English: How does Benepali work?
Estonian: Kuidas Benepali toimib?
English: Benepali is an anti-inflammatory medicine.
Estonian: Benepali on põletikuvastane ravim.
English: A study was carried out to show that Benepali produces similar levels of the active substance in the body to Enbrel.
Estonian: Viidi läbi uuring näitamaks, et Benepali põhjustab kehas samasuguse toimeaine sisalduse kui Enbrel.
English: How is Benepali used?
Estonian: Kuidas Benepalit kasutatakse?
English: Therefore, the CHMP's view was that, as for Enbrel, the benefits outweighs the identified risks.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu Enbreli korral, ületab ka ravimi Benepali kasulikkus sellega kaasnevad riskid.
English: − patients aged two to 17 years with disease that affects many joints (polyarthritis which is rheumatoid-factor-positive or -negative) and disease that starts in a few joints and then extends to many (oligoarthritis) and have not responded adequately to or cannot take methotrexate;
Estonian: − 2-17-aastased patsiendid, kellel on põletik mitmes liigeses (positiivse või negatiivse reumatoidfaktoriga polüartriit) või kellel oli põletik esialgu mõnes liigeses, aga levis seejärel mitmesse liigesesse (oligoartriit) ning kellel ei ole tekkinud metotreksaadiga piisavat ravivastust või kes ei talu metotreksaati;
English: For more information about treatment with Benepali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Benepaliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects reported with Benepali, see the package leaflet.
Estonian: Benepali kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What benefits of Benepali have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Benepali kasulikkus?
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) with moderate to severe disease in adults and in patients from the age of six years with long-term severe disease.
Estonian: • Naastuline psoriaas (punaseid ketendavaid nahalaike põhjustav haigus) täiskasvanutel mõõdukas kuni raskes vormis ja vähemalt 6-aastastel lastel kroonilises (pikaajalises) vormis.
English: Laboratory studies comparing Benepali with Enbrel have shown that the active substance in Benepali is highly similar to that in Enbrel in terms of structure, purity and biological activity.
Estonian: Benepalit võrreldi Enbreliga laboriuuringutes, mis tõendasid, et Benepali toimeaine sarnaneb struktuuri, puhtuse ja bioloogilise toime poolest Enbreli toimeainega.
English: Benepali contains the active substance etanercept and is a ‘biosimilar medicine'.
Estonian: Benepali sisaldab toimeainena etanertsepti ja on bioloogiliselt sarnane ravim.
English: − adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and who have not responded adequately to or cannot take methotrexate;
Estonian: − 12-17-aastased noorukid, kellel on psoriaatiline artriit (punaseid ketendavaid nahalaike ja liigesepõletikku põhjustav haigus) ning kellel ei ole tekkinud metotreksaadiga piisavat ravivastust või kes ei talu metotreksaati;
English: Benepali is available as pre-filled syringes or pens containing a solution for injecting under the skin.
Estonian: Benepalit turustatakse eeltäidetud süstaldes või pensüstaldes, mis sisaldavad naha alla süstitavat lahust.
English: − adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment;
Estonian: − 12-17-aastased noorukid, kellel on entesiidiga seotud artriit ning kellel ei ole tekkinud standardraviga piisavat ravivastust või kes ei talu standardravi.
English: Benepali treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Benepali is used to treat.
Estonian: Ravi Benepaliga tohib alustada üksnes eriarst, kes on kogenud nende haiguste diagnoosimises ja ravis, mille raviks Benepalit kasutatakse, ning ravi peab toimuma tema järelevalve all.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Benepali has a highly similar structure, purity and biological activity to Enbrel and is distributed in the body in the same way.
Estonian: Inimravimite komitee vaatas läbi andmed, millega tõendati, et Benepali sarnaneb struktuuri, puhtuse ja bioloogilise toime poolest Enbreliga ning jaotub organismis samamoodi kui Enbrel.
English: • moderate to severe rheumatoid arthritis (an immune-system disease causing inflammation of the joints) in adults (aged 18 years or over).
Estonian: • Täiskasvanute (vähemalt 18-aastaste) mõõdukas kuni raske reumatoidartriit (liigesepõletikku põhjustav immuunsüsteemi haigus).
English: • severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) who have not responded adequately to other treatments;
Estonian: • Raske anküloseeriv spondüliit (lülisamba liigeste põletikku põhjustav haigus) täiskasvanutel, kellel ei ole muu raviga tekkinud piisavat ravivastust.
English: The European Commission issued a decision on:
Estonian: Euroopa Komisjon tegi otsuse:
English: Outcome of four procedures under Article 20 of Regulation (EC) No 726/2004 and of one procedure under Article 31 of Directive 2001/83/EC as amended
Estonian: Määruse (EÜ) nr 726/2004 artikli 20 kohase nelja menetluse ja muudetud direktiivi 2001/83/EÜ artikli 31 kohase ühe menetluse tulemused
English: 20 February 2013 EMA/796016/2012 rev.1
Estonian: 20. veebruar 2013 EMA/796016/2012 rev.1
English: Hence, the results of the studies concerned could not be considered reliable.
Estonian: Selle tõttu ei saa asjaomaste uuringute tulemusi pidada usaldusväärseteks.
English: More information on these medicines can be found on the EMA website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Nende ravimite lisateave on EMA veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The CHMP confirmed its previous conclusions on these medicines.
Estonian: Inimravimite komitee kinnitas nende ravimite kohta oma varasemaid järeldusi.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Estonian: • Kui patsientidel tekib küsimusi, tuleb pöörduda arsti või apteekri poole.
English: Consequently, the European Commission asked the CHMP to assess whether the identified issues have an impact on the benefit-risk balance of the centrally authorised medicines concerned, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Estonian: Seetõttu küsis Euroopa Komisjon inimravimite komiteelt hinnangut, kas tuvastatud probleemid mõjutavad asjaomaste tsentraalse müügiloaga ravimite kasulikkuse ja riski suhet, ning arvamust, kas nende ravimite müügiload kogu Euroopa Liidus tuleks säilitada, muuta, peatada või tühistada.
English: • Fenofibrato Pensa and Fenofibrato Ranbaxy: 20 February 2013
Estonian: • Fenofibrato Pensa ja Fenofibrato Ranbaxy: 20. veebruar 2013
English: • Patients and prescribers should note that there are no safety concerns with any of these medicines currently on the market.
Estonian: • Patsiendid ja arstid peavad mõistma, et ühelgi nendest praegu turustatavatest ravimitest ei ole ohutusprobleeme.
English: The Committee considered the importance of the data from these studies in the context of the overall data submitted in the applications.
Estonian: Komitee analüüsis uuringuandmete tähtsust taotlustes esitatud koguandmete kontekstis.
English: • Patients who are taking any of the generic medicines that have been suspended should be aware that alternative treatments are available.
Estonian: • Patsiendid, kes võtavad mis tahes geneerilisi ravimeid, mille müügiluba on peatatud, peavad teadma, et on olemas ka samaväärseid muid ravimeid.
English: During a re-examination procedure for Fenofibrato Pensa and Fenofibrato Ranbaxy, the company submitted new data, which is not permitted in the context of a re-examination.
Estonian: Fenofibrato Pensa ja Fenofibrato Ranbaxy taasläbivaatamise menetluse ajal esitas ettevõte uusi andmeid, mis ei ole taasläbivaatamise kontekstis lubatud.
English: One of the studies is a ‘pharmacokinetic' study in children, whose results are included in the product information.
Estonian: Üks uuringuist on farmakokineetikauuring lastel, mille tulemused sisalduvad ravimiteabes.
English: At the request of the company that markets Fenofibrato Pensa and Fenofibrato Ranbaxy, the CHMP reexamined the initial opinion for these medicines, and confirmed its previous recommendation on 13 December 2012.
Estonian: Fenofibrato Pensat ja Fenofibrato Ranbaxyt turustava ettevõtte palvel analüüsis inimravimite komitee uuesti nende ravimite kohta antud algset arvamust ja 13. detsembril 2012 kinnitas oma varasemat soovitust.
English: The CHMP also requested the companies to provide any additional relevant data, which had not been submitted as part of the initial applications.
Estonian: Komitee palus ka ettevõtetel esitada algsetes taotlustes esitamata asjakohaseid lisaandmeid.
English: For Temodal and Tygacil the findings have no impact on the benefit-risk balance of these medicines and no further action is needed.
Estonian: Temodali ja Tygacili korral ei mõjuta leiud ravimite kasulikkuse ja riski suhet ning meetmeid võtta ei ole vaja.
English: Nevertheless the CHMP requested the company to update the product information with revised data.
Estonian: Sellele vaatamata palus inimravimite komitee uuendada ravimiteavet läbivaadatud andmetega.
English: However, as Tygacil is not approved for use in this population, no specific action was considered necessary.
Estonian: Et Tygacil ei ole selles vanuserühmas näidustatud, ei peeta konkreetseid meetmeid vajalikuks.
English: • Ribavirin Teva and Ribavirin Teva Pharma B.V., generic medicines containing ribavirin, used for the treatment of hepatitis C (a disease of the liver due to an infection with the hepatitis C virus); 1 Procedure numbers: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
Estonian: 1 Menetluste numbrid: EMEA/H/C/001018/A-20/0008, EMEA/H/C/001064/A-20/0007, EMEA/H/C/000229/A-20/0060, EMEA/H/C/000644/A-20/0072, EMEA/H/A-31/001340.
English: In July 2012, the CHMP had already completed a similar review of three other medicines (Conbriza, PecFent and Torisel) and concluded that there is no impact on the benefit-risk balance of these medicines and that the marketing authorisation should be maintained.
Estonian: 2012. aasta juulis lõpetas inimravimite komitee kolme muu ravimi (Conbriza, PecFent ja Torisel) sarnase läbivaatamise ning järeldas, et mõju nende ravimite kasulikkuse ja riski suhtele puudub ning müügiload tuleb säilitada.
English: As the results of these studies could not be considered reliable, the CHMP concluded that the marketing authorisation of these medicines should be suspended until the companies provide adequate data.
Estonian: Et nende uuringute tulemusi ei peeta usaldusväärseteks, otsustas inimravimite komitee nende ravimite müügiloa peatada, kuni ettevõtted esitavad piisavad andmed.
English: On 20 September 2012, the European Medicines Agency completed a review of nine centrally and nationally authorised medicines2, following concerns over the conduct of laboratory analyses of certain studies submitted as part of their marketing authorisation applications.
Estonian: Euroopa Ravimiamet (EMA) lõpetas 20. septembril 2012 üheksa tsentraalse ja riikliku müügiloaga ravimi andmete läbivaatamise2 pärast probleemide tekkimist teatud uuringute laborianalüüsidega, mis esitati koos müügilubade taotlustega.
English: The studies concerned were all conducted at the Cetero Research facility in Houston, Texas, USA.
Estonian: Kõik asjaomased uuringud toimusid Cetero Researchi keskuses (USA, Texase osariik, Houston).
English: In addition, the UK Medicines Regulatory Agency requested the CHMP to carry out the same assessment for the concerned nationally authorised medicines.
Estonian: Samuti palus Ühendkuningriigi ravimiamet inimravimite komiteel hinnata samamoodi asjaomaseid riiklike müügilubadega ravimeid.
English: Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.
Estonian: Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva ja Ribavirin Teva Pharma B.V.
English: • Ribavirin Teva Pharma B.V: 06 December 2012
Estonian: • Ribavirin teva Pharma B.V: 06 detsember 2012
English: For more information, see: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf
Estonian: Lisateave: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/07/WC500130159.pdf bioekvivalentsusuuringud geneeriliste ravimite müügiloa taotluse kohustuslik osa.
English: In the absence of reliable data, the CHMP recommended that their marketing authorisation should be suspended until adequate data are provided.
Estonian: Usaldusväärsete andmete puudumisel soovitas inimravimite komitee nende ravimite müügiload peatada kuni piisavate andmete esitamiseni.
English: The Committee noted that the studies conducted at this facility do not support any indication or prescribing recommendation for Tygacil.
Estonian: Inimravimite komitee märkis, et keskuses toimunud uuringud ei toeta ühtki Tygacili näidustust ega määramissoovitust.
English: The Committee concluded that the data from these studies were confirmed by other studies conducted elsewhere, and therefore that there is no impact on the benefit-risk balance of Temodal and no further action is needed.
Estonian: Komitee järeldas, et uuringuandmeid kinnitasid teised, mujal korraldatud uuringud, ning seetõttu mõju Temodali kasulikkuse ja riski suhtele puudub.
English: For these generic medicines, the studies conducted at the Texas-based Cetero Research facility were bioequivalence studies, to demonstrate that they produce the same levels of the active substance in the body as their reference medicines.
Estonian: Nende geneeriliste ravimite bioekvivalentsusuuringud toimusid Texases Cetero Researchi keskuses ja nende eesmärk oli tõendada, et need tekitavad organismis sama toimeainesisalduse kui võrdlusravimid.
English: The EMA was made aware that recent inspections of the Texas-based Cetero Research facility by the US Food and Drug Administration had raised concerns over the way laboratory analyses of certain studies, called ‘bio-analytical' studies, were conducted at this facility in the period from April 2005 to June 2010.
Estonian: EMA-le teatati, et USA toidu- ja ravimiamet avastas Texase osariigis Houstoni Cetero Researchi keskuse hiljutisel kontrollimisel puudusi teatud bioanalüütilistes uuringutes, mis olid tehtud keskuses ajavahemikus aprill 2005 - juuni 2010.
English: In July 2012, the CHMP had concluded a similar review for three other concerned centrally authorised medicines: Conbriza, PecFent and Torisel.3
Estonian: 2012. aasta juulis lõpetas inimravimite komitee veel kolme tsentraalse müügiloaga ravimi - Conbriza, PecFent ja Torisel - sarnase läbivaatamise.
English: • Ribavirin Teva: 06 December 2012
Estonian: • Ribavirin Teva: 06 detsember 2012
English: This review was initiated by the European Commission for the centrally authorised medicines and by the UK Medicines Regulatory Agency for the nationally authorised medicines.
Estonian: Tsentraalse müügiloaga ravimite menetluse algatas Euroopa Komisjon ja riikliku müügiloaga ravimite menetluse Ühendkuningriigi ravimiamet.
English: The CHMP noted that the studies conducted at this facility were two studies submitted in support of the approval of Temodal solution for infusion.
Estonian: Inimravimite komitee märkis, et keskuses toimus kaks uuringut, mis esitati Temodali infusioonilahuse müügiloa toetuseks.
English: The CHMP reviewed the bio-analytical studies performed at Texas-based Cetero Research facility that had been submitted as part of the marketing authorisation applications of the medicines concerned.
Estonian: Inimravimite komitee vaatas läbi Texases Cetero Researchi keskuses toimunud bioanalüütilised uuringud, mis esitati asjaomaste ravimite müügiloa taotluste osana.
English: In total, seven centrally authorised medicines and five nationally authorised medicines were identified, whose marketing authorisation applications included data from studies conducted at this Cetero Research facility.
Estonian: Kokku tuvastati seitse tsentraalse müügiloaga ja viis riikliku müügiloaga ravimit, mille müügiloa taotlused sisaldasid Cetero Researchi keskuses korraldatud uuringute andmeid.
English: Which medicines are affected by the Agency's review?
Estonian: Mis ravimeid EMA menetlus käsitleb?
English: • Leflunomide Actavis and Leflunomide Apotex, generic medicines containing the active substance leflunomide, used for the treatment of rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
Estonian: • Leflunomide Actavis ja Leflunomide Apotex, leflunomiidi sisaldavad geneerilised ravimid, mida kasutatakse reumatoidartriidi (immuunsüsteemi haigus, mis põhjustab liigesekahjustusi ja
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that for seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.) some of the studies that supported their authorisation could not be considered reliable.
Estonian: EMA inimravimite komitee järeldas, et seitsme ravimi korral (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva ja Ribavirin Teva Pharma B.V.)
English: • Cilazapril Teva and associated names: 10 December 2012
Estonian: • Cilazapril Teva ja sarnased nimetused: 10. detsember 2012