natgillin/translations-raw huggingface dataset:
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of EQUIOXX exceed the risks for the treatment of relief of pain and inflammation in horses and recommended that EQUIOXX be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila EQUIOXX pri lajšanju bolečin in vnetij pri konjih večje od z njim povezanih tveganj, in je priporočil, da se za zdravilo EQUIOXX odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ibaflin exceed the risks for the treatment of skin infections, and respiratory tract infections (upper tract) in dogs and cats, and acute, uncomplicated urinary tract infections in dogs, and recommended that Ibaflin be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Ibaflin pri zdravljenju okužb kože in okužb dihalnih poti (zgornjih dihalnih poti) pri psih in mačkah ter akutnih nezapletenih okužb sečil pri psih, večje od z njim povezanih tveganj, zato je priporočil, da se za zdravilo Ibaflin odobri dovoljenje za promet z zdravilom.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Improvac exceeded the risks for the reduction of boar taint caused by the key boar taint compound, androstenone, in entire male pigs following the onset of puberty.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Improvac pri zmanjšanju vonja po merjascu, ki ga povzroča ključna spojina slabega vonja, androstenon, pri vseh prašičih samcih po nastopu spolne zrelosti, večje od z njim povezanih tveganj.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ingelvac CircoFLEX exceed the risks for the active immunisation of pigs, over the age of two weeks, against PCV2, and recommended that Ingelvac CircoFLEX be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) meni, da so koristi zdravila Ingelvac CircoFLEX za aktivno imunizacijo prašičev, starejših od dveh tednov, proti PCV2 večji od z njim povezanih tveganj, in priporoča odobritev dovoljenja za promet z zdravilom Ingelvac CircoFLEX.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Leucofeligen FeLV/RCP exceed the risks for the active immunisation of cats from eight weeks of age against the diseases listed above.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva Leucofeligen FeLV/RCP za aktivno imunizacijo mačk, starejših od osem tednov, proti zgoraj navedenim boleznim večje od tveganj.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Leucogen exceed the risks for the active immunisation of cats from eight weeks of age against feline leukaemia, and recommended that Leucogen be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi cepiva Leucogen za aktivno imunizacijo mačk, starejših od osem tednov, proti mačji levkemiji večje od tveganj, in priporočil odobritev dovoljenja za promet z zdravilom Leucogen.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of NexGard exceed the risks for the approved indications and recommended that NexGard be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila NexGard večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Onsior exceed the risks for the treatment of dogs and cats in the approved indications and recommended that Onsior should be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Onsior pri zdravljenju psov in mačk pri odobrenih indikacijah večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Panacur AquaSol exceed its risks for the approved indications and recommended that Panacur AquaSol be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Panacur AquaSol večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Pexion exceed the risks for the approved indications and recommended that Pexion be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Pexion večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV M Hyo exceed the risks for the approved indication and recommended that Porcilis PCV M Hyo be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Porcilis PCV M Hyo večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Procox outweigh the risks when used for the approved indications and recommended that Procox be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Procox večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RC exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RC be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax RC za aktivno imunizacijo mačk, starejših od osem tednov, proti zgoraj navedenima boleznima večje od tveganj, in priporočil odobritev dovoljenja za promet z zdravilom Purevax RC.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCP exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCP be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax RCP za aktivno imunizacijo mačk, starejših od osem tednov, proti zgoraj navedenim boleznim večje od tveganj, in priporočil odobritev dovoljenja za promet z zdravilom Purevax RCP.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of RHINISENG exceed the risks for the treatment of piglets via colostrum from sows and gilts actively immunised with the vaccine to prevent the clinical signs and lesions of progressive and non- progressive atrophic rhinitis and recommended that RHINISENG be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila RHINISENG pri zdravljenju pujskov prek kolostruma po aktivni imunizaciji svinj in mladic za preprečevanje kliničnih znakov in lezij progresivnega in neprogresivnega atrofičnega rinitisa večje od z njim povezanih tveganj, zato je priporočil odobritev dovoljenja za promet z zdravilom RHINISENG.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Semintra exceed the risks for the approved indications and recommended that Semintra be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Semintra večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Trifexis exceed the risks for the approved indications and recommended that Trifexis be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Trifexis večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Vectra 3D exceed the risks for the approved indications and recommended that Vectra 3D be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Vectra 3D večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Vectra Felis exceed the risks for the approved indications and recommended that Vectra Felis be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Vectra Felis večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Melosus has been shown to be bioequivalent to Metacam.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da se je zdravilo Melosus v skladu z zahtevami Evropske unije izkazalo biološko enakovredno zdravilu Metacam.
The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of Monensin in Kexxtone in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Odbor za zdravila za uporabo v veterinarski medicini je priporočil vključitev monenzina v zdravilu Kexxtone v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.
The Committee further noted that the overall safety profile of Adcetris was acceptable for these patients.
Odbor je nadalje zaključil, da je celokupni varnostni profil zdravila Adcetris za te bolnike sprejemljiv.
The Committee has nonetheless recommended that further studies be carried out to investigate this concern.
Odbor je priporočil, da se izvedejo nadaljnje študije za proučitev tega pomisleka.
The Committee has recommended that further studies be carried out to investigate this concern.
Odbor je priporočil, da se izvedejo nadaljnje študije za preučitev tega pomisleka.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Exelon’s benefits did not outweigh its risks.
Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Exelon ne odtehtajo njegovih tveganj.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Prometax’s benefits did not outweigh its risks.
Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Prometax ne odtehtajo njegovih tveganj.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Rivastigmine 1 A Pharma’s benefits did not outweigh its risks.
Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Rivastigmine 1 A Pharma ne odtehtajo njegovih tveganj.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Rivastigmine Hexal’s benefits did not outweigh its risks.
Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Rivastigmine Hexala ne odtehtajo njegovih tveganj.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Rivastigmine Sandoz’s benefits did not outweigh its risks.
Odbor je prvotno sklenil, da za zdravljenje demence, ki je posledica Parkinsonove bolezni, koristi zdravila Rivastigmine Sandoz ne odtehtajo njegovih tveganj.
The Committee noted however that long-term use of SERMs might be associated with risks such as endometrial hyperplasia, stroke and venous thromboembolism and requested that further studies be carried out to investigate these risks with Senshio.
Vendar pa je opozoril, da je lahko dolgotrajna uporaba selektivnih modulatorjev estrogenskih receptorjev povezana s tveganji za hiperplazijo endometrija, kap in vensko tromboembolijo, ter priporočil, naj se izvedejo nadaljnje študije, da bi preučili ta tveganja pri uporabi zdravila Senshio.
The Committee noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, including patients on maximum recommended doses of statins or those intolerant to them, Praluent showed an important reduction in LDL-cholesterol levels, which is a known risk factor for cardiovascular (affecting the heart and blood vessels) disease.
Odbor je ugotovil, da so v vseh študijah z zdravilom Praluent pri bolnikih s primarno hiperholesterolemijo in mešano dislipidemijo, vključno pri bolnikih, ki so uporabljali največji priporočeni odmerek statinov, in bolnikih, ki statinov niso prenašali, dokazali pomembno znižanje ravni holesterola LDL, ki je znani dejavnik tveganja za srčno-žilne bolezni (bolezni, ki prizadenejo srce in krvne žile).
The Committee noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, including patients on maximum recommended doses of statins or those intolerant to them, Repatha showed an important reduction in LDL-cholesterol levels, which is a known risk factor for cardiovascular disease.
Ugotovil je, da so v vseh študijah z zdravilom Repatha pri bolnikih s primarno hiperholesterolemijo in mešano dislipidemijo, vključno z bolniki, ki so jemali največji priporočeni odmerek statinov, ali tistimi, ki jih ne prenašajo, dokazali pomembno znižanje ravni holesterola LDL, ki je znani dejavnik tveganja za srčno-žilne bolezni.
The Committee noted that Blincyto is beneficial for high risk adults with Ph- B-precursor ALL who have few therapeutic options and who generally have a poor prognosis.
Menil je, da je zdravilo Blincyto koristno za odrasle bolnike z akutno limfoblastno levkemijo predhodniških celic B z negativnim kromosomom Philadelphia, pri katerih obstaja visoko tveganje ter ki imajo omejene terapevtske možnosti in na splošno slabo prognozo.
The committee noted that Cystadane is not a substitute for other treatments.
Odbor je ugotovil, da zdravilo Cystadane ne more nadomestiti drugih načinov zdravljenja.
The Committee noted that hypophosphatasia is a serious and life-threatening disease for which no treatment is authorised.
Odbor je upošteval, da je hipofosfatazija resna in smrtno nevarna bolezen, za katero ni odobreno nobeno zdravljenje.
The Committee noted that Imbruvica was also effective in patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, a group with poor prognosis and few other treatment options.
Odbor je prav tako izpostavil, da je bilo zdravilo Imbruvica učinkovito tudi pri bolnikih z limfomom plaščnih celic, ki se ni odzval na predhodno zdravljenje ali se je po njem ponovil, tj. v skupini s slabo prognozo in malo drugimi možnostmi zdravljenja.
The Committee noted that in colorectal cancer the benefits in terms of extending patient survival were modest, but considered that they outweighed the risks in patients for whom there are no other remaining treatment options.
Opozoril je, da so bile pri kolorektalnem raku koristi pri podaljšanju preživetja bolnikov skromne, vendar je menil, da odtehtajo tveganja pri bolnikih, za katere ni na voljo nobenih drugih možnosti zdravljenja.
The Committee noted that Nimenrix offered the benefits of conjugated vaccines over conventional vaccines, including producing a strong immune response in young children.
Poudaril je, da zdravilo Nimenrix kot konjugirano cepivo ponuja boljše koristi kot tradicionalna cepiva, vključno s spodbujanjem močnega imunskega odziva pri mlajših otrocih.
The Committee noted that no other medicine was currently approved to treat the symptoms of MS and that the serious side effects with Fampyra were rare.
Odbor je ugotovil, da trenutno ni odobreno nobeno drugo zdravilo za zdravljenje simptomov MS in da so hudi neželeni učinki zdravila Fampyra redki.
The Committee noted that preparing for a potential flu pandemic in children and adolescents meets an important medical need.
Odbor je ugotovil, da priprava na morebitno pandemijo gripe pri otrocih in mladostnikih izpolnjuje pomembno zdravstveno potrebo.
The Committee noted that Stocrin has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Ugotovil je, da zdravilo Stocrin ni bilo ustrezno raziskano pri bolnikih z napredovalo boleznijo (število celic CD4 pod 50 celic/mm3) ali po zdravljenju z zaviralci proteaze (drugo vrsto protivirusnega zdravila), ki ni bilo uspešno.
The Committee noted that Sustiva has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Ugotovil je, da zdravilo Sustiva ni bilo ustrezno raziskano pri bolnikih z napredovalo boleznijo (številom celic CD4 pod 50 celic/mm3) ali po zdravljenju z zaviralci proteaze (drugo vrsto protivirusnega zdravila), ki ni bilo uspešno.
The Committee noted that the dual combination with ribavirin was shown to be effective against long- term hepatitis C virus infection in adults and children.
Odbor je opozoril, da se je dvotirno zdravljenje z ribavirinom izkazalo za učinkovito pri dolgotrajni okužbi z virusom hepatitisa C pri odraslih in otrocih.
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.
Ugotovil je, da se je kakovost življenja bolnikov, zdravljenih z zdravilom Jakavi, izboljšala, vendar pa je treba učinke zdravila na podaljšanje življenja bolnikov ali upočasnitev napredovanja bolezni ali pojava levkemije še oceniti.
The Committee noted that there were very few alternative treatments for those patients.
Odbor je dodal, da za tovrstne bolnike ni na voljo veliko alternativnih zdravljenj.
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.
Odbor je ugotovil, da ta indikacija temelji na študijah, opravljenih z bolniki, ki pred tem niso prejemali zdravljenja zaradi okužbe s HIV ali katerih okužba je bila že prej dobro nadzorovana s protivirusnimi zdravili, medtem ko bolniki, ki se na prejšnje zdravljenje HIV niso odzivali, niso bili vključeni v študije zdravila Emtriva.
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.
Odbor je opozoril, da je za bolnike, mlajše od pet let, pomembno, da prejemajo zdravljenje, če imajo hudo obliko MPS VI, čeprav niso bili vključeni v glavno študijo z zdravilom Naglazyme.
The Committee noted the potential risk for QTc interval prolongation, and measures were introduced to minimise this risk.
Odbor je opozoril na možno tveganje podaljšanja intervala QTc in uvedel ukrepe za zmanjšanje tveganja.
The Committee recommended that Abseamed be given marketing authorisation.
Priporočil je, da se za zdravilo Abseamed izda dovoljenje za promet.
The Committee recommended that Binocrit be given marketing authorisation.
Priporočil je, da se za zdravilo Binocrit izda dovoljenje za promet.
The Committee recommended that Bortezomib Accord be approved for use in the EU.
Priporočil je, da se zdravilo Bortezomib Accord odobri za uporabo v EU.
The Committee recommended that Budesonide/Formoterol Teva Pharma B.V. be given marketing authorisation.
Priporočil je, da se za zdravilo Budesonide/Formoterol Teva Pharma B.V. izda dovoljenje za promet.
The Committee recommended that Clopidogrel Krka be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Clopidogrel Krka dobri dovoljenje za promet.
The Committee recommended that Clopidogrel Qualimed be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Clopidogrel Qualimed odobri dovoljenje za promet.
The Committee recommended that Clopidogrel ratiopharm be approved for use in the EU.
Priporočil je, da se zdravilo Clopidogrel ratiopharm odobri za uporabo v EU.
The Committee recommended that Clopidogrel TAD be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Clopidogrel TAD odobri dovoljenje za promet.
The Committee recommended that Clopidogrel Teva Pharma B.V. be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Clopidogrel Teva Pharma B.V. odobri dovoljenje za promet.
The Committee recommended that Clopidogrel Teva Pharma be given marketing authorisation.
Priporočil je, da se za zdravilo Clopidogrel Teva Pharma izda dovoljenje za promet.
The Committee recommended that Ebilfumin be approved for use in the EU.
Priporočil je, da se zdravilo Ebilfumin odobri za uporabo v EU.
The Committee recommended that Econor should be given a marketing authorisation.
Priporočil je, da se za zdravilo Econor odobri dovoljenje za promet.
The Committee recommended that Emtriva be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Emtriva.
The Committee recommended that Epoetin Alfa Hexal be given marketing authorisation.
Priporočil je, da se za zdravilo Epoetin Alfa Hexal izda dovoljenje za promet.
The Committee recommended that Evra be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Evra odobri dovoljenje za promet.
The Committee recommended that Filgrastim ratiopharm be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Filgrastim ratiopharm odobri dovoljenje za promet.
The Committee recommended that Grastofil be approved for use in the EU.
Priporočil je, da se zdravilo Grastofil odobri za uporabo v EU.
The Committee recommended that Imatinib Accord be approved for use in the EU.
Priporočil je, da se zdravilo Imatinib Accord odobri za uporabo v EU.
The Committee recommended that Imatinib Actavis be approved for use in the EU.
Priporočil je, da se zdravilo Imatinib Actavis odobri za uporabo v EU.
The Committee recommended that Inflacam be approved for use in the EU.
Priporočil je, da se zdravilo Inflacam odobri za uporabo v EU.
The Committee recommended that Ixiaro be given marketing authorisation.
Priporočil je, da se za cepivo Ixiaro izda dovoljenje za promet.
The Committee recommended that Kineret be given marketing authorisation.
Priporočil je, da se zanj izda dovoljenje za promet.
The Committee recommended that Lamivudine Teva Pharma B.V. be given marketing authorisation.
Priporočil je, da se za zdravilo Lamivudine Teva Pharma B.V. izda dovoljenje za promet.
The Committee recommended that Leflunomide Teva be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Leflunomide Teva odobri dovoljenje za promet.
The Committee recommended that Leucofeligen FeLV/RCP be given a marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Leucofeligen FeLV/RCP.