natgillin/translations-raw huggingface dataset:
The Committee noted that the quality of life of patients treated with Jakavi was improved but that the medicine’s effects had still to be evaluated in terms of extending the life of patients or delaying the progress of the disease or the onset of leukaemia.
Komitee märkis, et Jakaviga ravitud patsientide elukvaliteet paranes, ent tuleb veel uurida ravimi toimeid elulemuse suurendamise ning haiguse süvenemise või leukeemia tekke edasilükkamise aspektist.
The Committee noted that there were very few alternative treatments for those patients.
Inimravimite komitee märkis, et nendele patsientidele ei ole palju muid raviviise.
The Committee noted that this indication is based on studies in patients who have not received HIV treatment before, or whose HIV is already well controlled with antiviral medicines, and that there was no experience of Emtriva in patients whose previous treatment for HIV was not working.
Komitee märkis, et see näidustus põhineb uuringutel patsientidega, kes ei olnud varem HIV-ravi saanud või kelle HIV allub juba hästi viiruseravimitele, ning et Emtriva kasutamise kohta ei ole kogemusi patsientide korral, kellel varasem HIV-ravi ei ole toiminud.
The Committee noted that treatments such as MACI are already established in clinical practice and that the results from the main study were consistent with results in the scientific literature.
Komitee märkis, et MACI-sarnased raviviisid on juba kliinilises kasutuses ja põhiuuringu tulemused olid kooskõlas teaduskirjanduses avaldatud tulemustega.
The Committee noted that, although patients under five years of age were not included in the main study of Naglazyme, it is important that they are treated if they have a severe form of MPS VI.
Inimravimite komitee märkis, et kuigi alla viieaastased patsiendid Naglazyme põhiuuringus ei osalenud, on nende ravimine oluline, kui neil on raskekujuline MPS VI.
The Committee noted the potential risk for QTc interval prolongation, and measures were introduced to minimise this risk.
Inimravimite komitee märkis, et ravimi kasutamisel tekib potentsiaalne oht QTc- intervalli pikenemiseks, mistõttu selle riski minimeerimiseks võeti vastavad meetmed.
The Committee recommended that Abseamed be given marketing authorisation.
Komitee soovitas anda Abseamedi müügiloa.
The Committee recommended that Binocrit be given marketing authorisation.
Komitee soovitas anda Binocriti müügiloa.
The Committee recommended that Bortezomib Accord be approved for use in the EU.
Komitee soovitas Bortezomib Accordi kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Clopidogrel Krka be given marketing authorisation.
Komitee soovitas anda Clopidogrel Krkale müügiloa.
The Committee recommended that Clopidogrel Qualimed be given marketing authorisation.
Komitee soovitas anda Clopidogrel Qualimedi müügiloa.
The Committee recommended that Clopidogrel ratiopharm be approved for use in the EU.
Komitee soovitas Clopidogrel ratiopharmi kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Clopidogrel TAD be given marketing authorisation.
Komitee soovitas anda Clopidogrel TADile müügiloa.
The Committee recommended that Clopidogrel Teva Generics B.V. be given marketing authorisation.
Komitee soovitas anda Clopidogrel Teva Generics B.V. müügiloa.
The Committee recommended that Clopidogrel Teva Pharma B.V. be given marketing authorisation.
Komitee soovitas anda ravimi müügiloa.
The Committee recommended that Clopidogrel Teva Pharma be given marketing authorisation.
Komitee soovitas anda Clopidogrel Teva Pharma müügiloa.
The Committee recommended that Ebilfumin be approved for use in the EU.
Komitee soovitas Eblifumini kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Econor should be given a marketing authorisation.
Komitee soovitas anda Econori müügiloa.
The Committee recommended that Emtriva be given marketing authorisation.
Komitee soovitas anda Emtrivale müügiloa.
The Committee recommended that Epoetin Alfa Hexal be given marketing authorisation.
Komitee soovitas anda Epoetin Alfa Hexali müügiloa.
The Committee recommended that Evra be given marketing authorisation.
Komitee soovitas anda Evrale müügiloa.
The Committee recommended that Filgrastim ratiopharm be given marketing authorisation.
Komitee soovitas anda Filgrastim ratiopharmile müügiloa.
The Committee recommended that Grastofil be approved for use in the EU.
Komitee soovitas Grastofili kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Imatinib Accord be approved for use in the EU.
Komitee soovitas ravimi Imatinib Accord kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Imatinib Actavis be approved for use in the EU.
Komitee soovitas ravimi Imatinib Actavis kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Inflacam be approved for use in the EU.
Komitee soovitas Inflacami kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Ixiaro be given marketing authorisation.
Komitee soovitas anda Ixiaro müügiloa.
The Committee recommended that Kineret be given marketing authorisation.
Komitee soovitas anda Kinereti müügiloa.
The Committee recommended that Lamivudine Teva Pharma B.V. be given marketing authorisation.
Komitee soovitas anda Lamivudine Teva Pharma B.V. müügiloa.
The Committee recommended that Leflunomide Teva be given marketing authorisation.
Komitee soovitas anda Leflunomide Teva müügiloa.
The Committee recommended that Leucofeligen FeLV/RCP be given a marketing authorisation.
Komitee soovitas anda Leucofeligen FeLV/RCP-le müügiloa.
The Committee recommended that Loxicom be given a marketing authorisation.
Komitee soovitas anda Loxicomi müügiloa.
The Committee recommended that Mimpara be given marketing authorisation.
Komitee soovitas anda Mimparale müügiloa.
The Committee recommended that Mozobil be given marketing authorisation.
Komitee soovitas anda Mozobilile müügiloa.
The Committee recommended that Nivestim be given marketing authorisation.
Komitee soovitas anda Nivestimi müügiloa.
The Committee recommended that Nordimet be approved for use in the EU.
Komitee soovitas Nordimeti kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that NovoSeven be given marketing authorisation.
Komitee soovitas anda NovoSeveni müügiloa.
The Committee recommended that Oprymea be given marketing authorisation.
Komitee soovitas anda Oprymea müügiloa.
The Committee recommended that Pioglitazone Accord be given marketing authorisation.
Komitee soovitas anda Pioglitazone Accordi müügiloa.
The Committee recommended that Pioglitazone Actavis be given marketing authorisation.
Komitee soovitas anda ravimi Pioglitazone Actavis Group müügiloa.
The Committee recommended that Remsima be approved for use in the EU.
Komitee soovitas Remsima kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Ribavirin Teva Pharma B.V. be given marketing authorisation.
Komitee soovitas anda ravimile Ribavirin Teva Pharma B.V. müügiloa.
The Committee recommended that Sevohale be approved for use in the EU.
Komitee soovitas Sevohalei kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Silapo be given marketing authorisation.
Komitee soovitas anda Silapo müügiloa.
The Committee recommended that Stocrin be given marketing authorisation.
Komitee soovitas anda Stocrini müügiloa.
The Committee recommended that Sustiva be given marketing authorisation.
Komitee soovitas anda Sustiva müügiloa.
The Committee recommended that Taxespira be approved for use in the EU.
Horizon, Honey Lane, Hurley, Maidenhead,
The Committee recommended that Trazec be given marketing authorisation.
Komitee soovitas anda Trazecile müügiloa.
The Committee recommended that Tritanrix HepB be given marketing authorisation.
Komitee soovitas anda Tritanrix HepB-le müügiloa.
The Committee recommended that Vedrop be given marketing authorisation.
Komitee soovitas anda Vedropile müügiloa.
The Committee recommended that Voriconazole Hospira be approved for use in the EU.
Komitee soovitas Voriconazole Hospira kasutamise Euroopa Liidus heaks kiita.
The Committee recommended that Xagrid be given marketing authorisation.
Komitee soovitas anda Xagridi müügiloa.
The Committee recommended that Zerene be given marketing authorisation.
Komitee soovitas anda Zerenele müügiloa.
The Committee recommended that Zoledronic acid Accord be approved for use in the EU.
Komitee soovitas ravimi Zoledronic Acid Accord kasutamise Euroopa Liidus heaks kiita.
The Committee therefore concluded that Cholib’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Inimravimite komitee järeldas seetõttu, et Cholibi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The Committee therefore concluded that the benefits of Ameluz are greater than its risks and recommended that it be granted marketing authorisation.
Inimravimite komitee järeldas, et Ameluzi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee therefore concluded that the benefits of Daklinza outweigh its risks and recommended that it be approved for use in the EU.
Inimravimite komitee järeldas seetõttu, et Daklinza kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The Committee therefore concluded that the benefits of Dexdor are greater than its risks and recommended that it be granted marketing authorisation.
Seetõttu otsustas inimravimite komitee, et Dexdori kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee therefore concluded that the benefits of Exviera outweigh its risks and recommended that it be approved for use in the EU.
Inimravimite komitee järeldas seetõttu, et Exviera kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The Committee therefore concluded that the benefits of Komboglyze outweigh its risks and recommended that it be given marketing authorisation.
Seetõttu järeldas komitee, et Komboglyze kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimile müügiloa.
The Committee therefore concluded that the benefits of Viekirax outweigh its risks and recommended that it be approved for use in the EU.
Inimravimite komitee järeldas seetõttu, et Viekiraxi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The Committee therefore concluded that the medicine’s benefits are greater than its risk and recommended that it be approved for use in the EU.
Inimravimite komitee otsustas seetõttu, et ravimi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The Committee therefore concluded that Zydelig’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Inimravimite komitee järeldas seetõttu, et Zydeligi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The Committee therefore considered that Spedra’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Inimravimite komitee järeldas seetõttu, et Spedra kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The Committee therefore decided that Buccolam’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Seega otsustas komitee, et Buccolami kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee therefore decided that DuoPlavin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas seetõttu, et DuoPlavini kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee therefore decided that HyQvia’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Seetõttu otsustas inimravimite komitee, et HyQvia kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
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.
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.
The Committee therefore decided that Rasitrio’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Seetõttu otsustas komitee, et Rasitrio kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee therefore decided that the benefits of Colobreathe are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas, et Colobreathe’i kasulikkus on suurem kui sellega kaasnevad riskid ja soovitas anda ravimi müügiloa.
The Committee therefore decided that Trevicta’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Inimravimite komitee otsustas seepärast, et Trevicta kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The Committee therefore decided that Truberzi’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Seetõttu otsustas inimravimite komitee, et Truberzi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The Committee took the view that, although the proportion of patients with Cushing’s disease who responded and whose cortisol levels in the urine normalised was small, Signifor could be of benefit in patients who have failed surgery or where surgery is not an option.
Inimravimite komitee võttis seisukoha, et kuigi Cushingi tõvega patsiente, kes allusid ravile ja kelle uriini kortisoolisisaldus normaliseerus, oli vähe, võib patsientidele, kelle operatsioon ei õnnestunud või keda ei saa opereerida, olla Signifor kasulik.
The common adverse reactions seen up to day 16 of the field trials are listed in the following table and compared to placebo:
Sagedased kõrvaltoimed, mida täheldati väliuuringus 16. päevani, on võrrelduna platseeboga toodud välja allpool tabelis.
The common adverse reactions seen up to day 16 of the field trials are listed in the following table and compared to placebo:
Sagedasi kõrvaltoimeid, mida täheldati väliuuringus 16. päevani, võrreldi platseeboga ja need on välja toodud allolevas tabelis.
The common side effects (may affect up to 1 in 10 people) are: Feeling sick
Sagedased kõrvaltoimed (võib esineda kuni ühel inimesel kümnest): iiveldus
The common side effects may affect up to 1 in 10 people:
Sageli esinevad kõrvaltoimed võivad tekkida kuni 1 inimesel 10st:
The company also carried out studies looking at the absorption of the orodispersible tablets and oral solution by the body.
Ettevõte viis läbi ka uuringud suus dispergeeruvate tablettide ja suukaudse lahuse imendumise kohta organismis.
The company also compared the combination tablet to separate tablets of lamivudine and zidovudine in 75 patients over 12 years of age who had not taken treatment for HIV infection before.
Ettevõte võrdles ka kombineeritud tabletti lamivudiini ja sidovudiini eraldi tablettide kasutamisega 75 vähemalt 12-aastasel noorukil ja täiskasvanul (kellel ei olnud HIV-nakkust varem ravitud).
The company also distributes information packs to provide healthcare workers, patients, and the male partners of female patients with information on the medicine’s side effects and the need to avoid pregnancy.
Ettevõte on koostanud ka teabepakmed, milles selgitab tervishoiutöötajatele, patsientidele ja naispatsientide meespartneritele ravimi kõrvalnähte ja vajadust rasestumist vältida.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate medicines.
Ettevõte uuris ka kombineeritud tableti imendumist organismis, võrreldes eraldi ravimite imendumisega.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate tablets.
Ettevõte uuris ka kombineeritud tableti imendumist organismis, võrreldes eraldi tablettide imendumisega.
The company also presented information from studies in 641 adults carried out using an earlier version of Humenza, containing a ‘bird flu’ strain H5N1.
Ettevõte esitas ka uuringu (641 patsienti) andmed, milles kasutati Humenza varasemat, linnugripiviiruse tüve H5N1 sisaldavat varianti.
The company also presented information on the use of Dukoral for the prevention of a severe type of traveller’s diarrhoea caused by a bacterium called ‘enterotoxigenic Escherichia coli’.
Ettevõte esitas ka andmeid Dukorali kasutamise kohta enterotoksigeense bakteri Escherichia coli põhjustatud reisil esineva raskekujulise kõhulahtisuse ennetamisel.
The company also presented results from a series of studies conducted with vaccines of similar composition but including different serotypes from the ones in BTVPUR to provide supportive information that could be used to calculate the effectiveness of the vaccine.
Samuti esitas ettevõte vaktsiini efektiivsuse arvutamise toetuseks tulemusi mitmest katsest, milles kasutati vaktsiiniga BTVPUR sarnase koostisega, kuid muid serotüüpe sisaldavaid vaktsiine.
The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant).
Ettevõte esitas ka täiendava uuringu tulemused, milles Thymanaxi võrreldi sertraliiniga (samuti antidepressant).
The company also presented the results of a further study comparing Valdoxan with sertraline (another antidepressant).
Ettevõte esitas ka täiendava uuringu tulemused, milles Valdoxani võrreldi sertraliiniga (samuti antidepressant).
The company also presented the results of a published study involving 1,002 patients, which compared the effects of Xeloda and 5-FU, taken in combination with platinum-containing medicines and epirubicin (another cancer medicine).
Ettevõte esitas ka 1002 patsiendiga läbiviidud avaldatud uuringu tulemused, milles võrreldi Xeloda ja 5-FU toimet nende manustamisel koos plaatinat sisaldavate ravimite ja epirubitsiiniga (samuti vähiravim).
The company also presented the results of a study comparing the effects of Abseamed injected under the skin with those of Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Ettevõte esitas ka uuringu tulemused, milles võrreldi naha alla süstitud Abseamedi toimet Eprex/Erypo toimega keemiaravi saanud 114 vähipatsiendil.
The company also presented the results of a study comparing the effects of Binocrit injected under the skin with those of Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Ettevõte esitas ka uuringu tulemused, milles võrreldi naha alla süstitud Binocriti toimet Eprex/Erypo toimega keemiaravi saanud 114 vähipatsiendil.
The company also presented the results of a study comparing the effects of Epoetin Alfa Hexal injected under the skin with those of Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Ettevõte esitas ka uuringu tulemused, milles võrreldi naha alla süstitud Epoetin Alfa Hexali toimet Eprex/Erypo toimega keemiaravi saanud 114 vähipatsiendil.
The company also presented the results of a study in 32 healthy people looking at the levels of saxagliptin in the blood when saxagliptin is taken at 2.5 mg twice daily compared with when it is taken at 5 mg once daily.
Ettevõte esitas ka tulemused 32 tervel inimesel tehtud uuringust, kus vaadeldi saksagliptiini sisaldust veres, kui saksagliptiini võeti kas 2,5 mg kaks korda ööpäevas või 5 mg üks kord ööpäevas.
The company also presented the results of a study looking at the combination of Thalidomide Celgene and dexamethasone as ‘induction’ treatment for multiple myeloma for use before high-dose chemotherapy.
Ettevõte esitas ka uuringu tulemused, milles vaadeldi Thalidomide Celgene ja deksametasooni kombinatsiooni toimet hulgimüeloomi induktsioonravina enne suureannuselist keemiaravi.
The company also presented the results of a study showing that the oral suspension produced the same levels of the active substance in the blood as the tablets.
Ettevõte esitas ka uuringu tulemused, mis näitasid, et suukaudse suspensiooniga ja tablettidega saavutati toimeaine sama sisaldus veres.
The company also presented the results of studies from the published literature looking at Thyrogen’s effect when it was used with a thyroglobulin test, but without a radioactive iodine scan.
Ettevõte esitas teaduskirjandusest ka selliste uuringute andmed, kus jälgiti Thyrogeni toimet, kui seda kasutati koos türeoglobuliini analüüsiga, kuid ilma radioaktiivse joodiga toimuva piltdiagnostikauuringuta.
The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an ‘allergen challenge’.
Ettevõte esitas ka tulemusi uuringutest, kus patsientidele manustati enne sihilikku kokkupuudet allergeeniga Emadinet, levokabastiini või platseebot (näiv ravim).
The company also provided data on the use of Cinryze in 91 patients to prevent attacks in patients undergoing a medical, surgical or dental procedure.
Ettevõte esitas samuti andmed Cinryze kasutamise kohta 91 patsiendil meditsiiniliste, hambaravi või kirurgiliste protseduuridega seotud episoodide profülaktikaks.
The company also used data from the scientific literature.
Ettevõte kasutas ka teaduskirjandusest pärit andmeid.
The company applied for an authorisation to use Increlex in these children, but withdrew its application after the end of the medicine’s assessment, as this disease is not listed in the medicine’s ‘orphan’ designation.
Ettevõte taotles müügiluba Increlexi kasutamiseks ka nende laste raviks, kuid võttis oma taotluse pärast ravimi hindamist tagasi, sest seda haigust ei sisaldu ravimi harvikravimiks nimetamise märkes.
The company carried out a ‘bioequivalence’ study to show that 500 mg Capecitabine Medac produces the same levels of capecitabine in the blood as 500 mg Xeloda.
Ettevõte korraldas bioekvivalentsuse uuringu, millega tõendas, et 500 mg ravimit Capecitabine Medac tekitab veres sama kapetsitabiinisisalduse kui 500 mg Xelodat.
The company carried out a ‘bioequivalence’ study to show that 500 mg Ecansya produces the same levels of capecitabine in the blood as 500 mg of the reference medicine.
Ettevõte korraldas bioekvivalentsuse uuringu, millega tõendas, et 500 mg ravimit Ecansya tekitab veres sama kapetsitabiinisisalduse kui 500 mg võrdlusravimit.
The company carried out ‘bioequivalence’ studies to show that Aripiprazole Sandoz is bioequivalent to the reference medicine, Abilify.
Ettevõte korraldas bioekvivalentsuse uuringud, et tõendada ravimi Aripiprazole Sandoz bioekvivalentsust võrdlusravimiga Abilify.
The company carried out ‘bioequivalence’ studies to show that taking Corbilta produces the same levels of levodopa, carbidopa and entacapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Ettevõte viis läbi bioekvivalentsuse uuringud, millega tõendas, et ravimi Corbilta kasutamisel on levodopa, karbidopa ja entakapooni sisaldus veres samasugune kui toimeainete võtmisel eraldi entakapooni tablettidena ning kombineeritud levodopa ja karbidopa tablettidena.
The company carried out ‘bioequivalence’ studies to show that taking Levodopa/Carbidopa/Entacapone Orion produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Ettevõte viis läbi bioekvivalentsuse uuringud, millega tõendas, et Stalevo kasutamisel on levodopa, karbidopa ja entakapooni sisaldus veres samasugune kui toimeainete võtmisel eraldi entakapooni tablettidena ning kombineeritud levodopa ja karbidopa tablettidena.