FrancophonIA/ELRC3.0 huggingface dataset:
English: All MAHs expressed their agreement with the overall recommended amendments to the SPC on the understanding that changes related to the indication in bipolar disorder are relevant to those
Slovenian: Vsi imetniki dovoljenja za promet z zdravilom so se strinjali s splošno priporočenimi spremembami povzetka glavnih značilnosti zdravila ob upoštevanju, da so spremembe, ki se nanašajo na indikacijo bipolarne motnje, pomembne za tiste imetnike dovoljenja za promet z zdravilom, ki dajejo vlogo za novo ali spremenjeno indikacijo.
English: The application was submitted to France as reference Member State and to Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Slovenian: Predlagatelj je vlogo predložil Franciji kot referenčni državi članici ter zadevnim državam članicam Avstriji, Belgiji, Bolgariji, Cipru, Češki republiki, Danski, Estoniji, Finski, Nemčiji, Grčiji, Madžarski, Irski, Italiji, Latviji, Litvi, Luksemburgu, Nizozemski, Norveški, Poljski, Portugalski, Romuniji, Slovaški, Sloveniji, Španiji in Združenemu kraljestvu.
English: The submitted studies are considered to be well conducted.
Slovenian: Predložene študije so bile ocenjene kot dobro izvedene.
English: However, any use of antibiotic will lead to increase of resistance and therefore, prudent use should always be recommended.
Slovenian: Vendar pa vsaka uporaba antibiotikov povzroči povečanje odpornosti, zato mora biti vedno priporočena preudarna uporaba.
English: The warnings in the product information remain appropriate.
Slovenian: Opozorila v informacijah o zdravilu so ustrezna.
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 24 January 2014, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No
Slovenian: Ker referenčna in zadevne države članice niso mogle doseči soglasja v zvezi s spremembo, je Francija 24. januarja 2014 zadevo napotila na odbor CVMP v skladu s členom 13(2) Uredbe Komisije (ES) št. 1234/2008.
English: 49071 Beaucouzé France
Slovenian: 49071 Beaucouzé Francija
English: Walton Manor, Walton Milton Keynes MK7 7AJ United Kingdom
Slovenian: Walton Manor, Walton Milton Keynes MK7 7AJ Združeno kraljestvo
English: D-85716 Unterschleißheim Germany
Slovenian: D-85716 Unterschleißheim Nemčija
English: The follow up of animals was sufficiently long as to observe the same clinical disease progression in the control group as in the field.
Slovenian: Spremljanje živali je potekalo dovolj časa, da so opazili enako klinično napredovanje bolezni v kontrolni skupini in na terenu.
English: This issue remained unsolved and therefore a CMDv procedure under Article 13(1) of Commission Regulation (EC) No 1234/2008 has started on 6 November 2013.
Slovenian: To vprašanje je ostalo nerešeno, zato je skupina CMD(v) 6. novembra 2013 začela postopek v skladu s členom 13(1) Uredbe Komisije (ES) št. 1234/2008.
English: The final outcome and the risk for relapse was assessed when the antimicrobial effect of Resflor has ceased.
Slovenian: Končni izid in tveganje za ponovitev bolezni so ocenili, ko je protimikrobni učinek zdravila Resflor prenehal.
English: The MIC90 of the total population of M. bovis was 4 µg/ml.
Slovenian: MIK90 celotne populacije bakterij M. bovis je bila 4 µg/ml.
English: Polígono Industrial El Montalvo I c/Zeppelín n° 6, parcela 38 37008 Carbajosa de la Sagrada - Salamanca Spain
Slovenian: Polígono Industrial El Montalvo I c/Zeppelín n° 6, parcela 38 37008 Carbajosa de la Sagrada - Salamanca Španija
English: MSD Animal Health, Lda.
Slovenian: Portugalska MSD Animal Health, Lda.
English: for avoiding bias.
Slovenian: za preprečevanje pristranskosti.
English: Germany Intervet Deutschland GmbH Feldstraße 1a
Slovenian: Intervet Deutschland GmbH Feldstraße 1a
English: Overall summary of the scientific evaluation of Resflor solution injectable and associated names (see annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Resflor raztopina za injiciranje in povezanih imen (glejte Prilogo I)
English: Intervet GesmbH Siemensstrasse 107 1210 Wien Austria
Slovenian: Intervet GesmbH Siemensstrasse 107 1210 Wien Austrija
English: In order to address the concerns raised by Denmark and Germany, the marketing authorisation holder was requested to provide all available efficacy data for Resflor, together with a justification for the recommended treatment dose and the appropriateness of the study design for the pivotal challenge study performed in 2012.
Slovenian: Da bi odpravili zadržke, ki sta jih izpostavili Danska in Nemčija, so imetnika dovoljenja za promet z zdravilom zaprosili, naj predloži vse razpoložljive podatke o učinkovitosti zdravila Resflor, skupaj z utemeljitvijo priporočenega odmerka za zdravljenje in primernosti zasnove študije za ključno provokacijsko študijo, izvedeno leta 2012.
English: This is in line with the recommendations of the CVMP guideline on statistical principles (EMA/CVMP/EWP/81976/2010)
Slovenian: To je v skladu s priporočili smernic odbora CVMP o statističnih načelih (EMA/CVMP/EWP/81976/2010)
English: The efficacy of Resflor against respiratory infection caused by M. bovis was demonstrated in two experimental models (performed in 2008 and 2012) and two clinical field trials (performed in 2004 and
Slovenian: Učinkovitost zdravila Resflor proti okužbam dihal, ki jih povzroča bakterija M. bovis , so dokazali na dveh poskusnih modelih (leta 2008 in 2012) ter v dveh kliničnih terenskih preskušanjih (izvedenih leta 2004 in 2005).
English: • the CVMP considered that no specific risk of antimicrobial resistance has been identified with the use of this product at the recommended dose;
Slovenian: • odbor CVMP je menil, da ni bilo ugotovljeno posebno tveganje za protimikrobno odpornost ob uporabi zdravila v priporočenem odmerku;
English: Based on the absence of standardised method to determine MIC, it is difficult to follow resistance evolution in the different publications.
Slovenian: Glede na to, da ni standardizirane metode za določitev MIK, je težko spremljati razvoj odpornosti v različnih publikacijah.
English: Treatment failures between Day 8 and Day 18 were considered relapses.
Slovenian: Neuspešnost zdravljenja med 8. in 18. dnem je veljala za ponovitev bolezni.
English: An additional statistical analysis has been carried out to demonstrate non-inferiority of florfenicol in comparison to the positive control with regards to the clinical cure rate on Day 7.
Slovenian: Izvedena je bila tudi dodatna statistična analiza, ki naj bi dokazala, da je florfenikol najmanj enakovreden v primerjavi s pozitivno kontrolo pri stopnji klinične ozdravitve na 7. dan.
English: Intervet Romania s.r.l.
Slovenian: Romunija Intervet Romania s.r.l.
English: Soseua de Centura no. 13A Comuna Chiajna Judet Ilfov
Slovenian: Soseua de Centura no. 13A Comuna Chiajna
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti, ciljnih živalskih vrst, način uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: The differences in daily failure rates from Day 5 to Day 18 between the two treatment groups were not statistically significant at any of these days nor was the overall difference in cumulative failure rates from Day 5 to Day 18 (29.9% vs. 23.6%; p = 0.3682).
Slovenian: Razlike v dnevnih stopnjah neuspešnosti zdravljenja od 5. do 18. dneva med obema zdravljenima skupinama niso bile statistično značilne na nobenega od teh dni, tako kot ni bila niti skupna razlika v kumulativnih stopnjah neuspešnosti od 5. do 18. dneva (29,9 % v primerjavi s 23,6 %; p = 0,3682).
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljaven povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, ki so nastale med postopkom Usklajevalne skupine.
English: Nevertheless, based on the pre-clinical data provided by the marketing authorisation holder, MICs of florfenicol against M. bovis strains isolated in several EU Member States between 2007 and 2013 ranged between 0.5 and >64 µg/ml.
Slovenian: Vendar predklinični podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom, kažejo, da so minimalne inhibitorne koncentracije florfenikola proti sevom bakterije M. bovis, ki so jih izolirali v več državah članicah EU med letoma 2007 in 2013, znašale od 0,5 do > 64 µg/ml.
English: During the variation procedure at the veterinary coordination group for mutual recognition and decentralised procedure (CMDv) a potential serious risk to animal health was identified by Denmark and Germany regarding the demonstration of efficacy in the clinical trials and the justification of the recommended treatment dose of Resflor in the treatment of respiratory infections caused by Mycoplasma bovis, which may be associated with an increased risk of development of antimicrobial resistance.
Slovenian: Med postopkom za spremembo, ki ga je vodila Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)), sta Danska in Nemčija opozorili na možno resno tveganje za zdravje živali, povezano z dokazovanjem učinkovitosti v kliničnih preskušanjih in utemeljitvijo priporočenega odmerka zdravila Resflor za zdravljenje okužb dihal, ki jih povzroča bakterija Mycoplasma bovis, saj bi lahko obstajalo povečano tveganje za razvoj protimikrobne odpornosti.
English: Quality, target animal safety, user safety, environmental risk and residues were not assessed in this referral procedure.
Slovenian: V tem napotitvenem postopku kakovost, varnost zdravila za ciljno živalsko vrsto, varnost zdravila za uporabnika, okoljska tveganja in ostanki niso bili obravnavani.
English: There is little information on how pharmacokinetic and pharmacodynamic data should be applied in the treatment of M. bovis infections.
Slovenian: Na voljo je malo informacij o tem, kako naj se farmakokinetični in farmakodinamični podatki uporabijo pri zdravljenju okužb, ki jih povzroča bakterija M. bovis.
English: The experimental study performed in 2008 was blinded, randomised, and compliant with good clinical practice (GCP).
Slovenian: Eksperimentalna študija, izvedena leta 2008, je bila slepa, randomizirana in skladna z dobro klinično prakso.
English: The success rate on Day 4 and Day 7 (primary endpoints) were significantly higher in the Resflor than in the saline group (Day 4: Resflor 96.9% versus saline 61.9%; Day 7: Resflor 92.2% versus saline 47.6%; p<0.0001 - Fischer exact test).
Slovenian: Stopnja uspešnosti na 4. dan in 7. dan (primarni končni točki) je bila znatno višja v skupini z zdravilom Resflor kot v skupini s fiziološko raztopino (4. dan: zdravilo Resflor 96,9 % v primerjavi s fiziološko raztopino 61,9 %; 7. dan: zdravilo Resflor 92,2 % v primerjavi s fiziološko raztopino 47,6 %; p < 0,0001 - Fischerjev eksaktni test).
English: The authorisation of florfenicol for the treatment of respiratory disease caused by M. bovis would avoid the use of Critically Important Antimicrobials and consequently could decrease the selection pressure for emergence of resistant strains from the usage of other classes of antibiotics such as macrolides and fluoroquinolones.
Slovenian: Z odobritvijo florfenikola za zdravljenje bolezni dihal, ki jih povzroča bakterija M. bovis, bi se izognili uporabi kritično pomembnih antibiotikov, s čimer bi lahko zmanjšali selekcijski pritisk, ki omogoča razvoj odpornih sevov, zaradi uporabe drugih skupin antibiotikov, kot so makrolidi in fluorokinoloni.
English: Mannheimia haemolytica was the most prevalent pathogen pre-treatment (142 isolates).
Slovenian: Najpogostejši patogen pred zdravljenjem je bila bakterija Mannheimia haemolytica (142 izolatov).
English: The marketing authorisation holder Intervet International BV, submitted an application for a type II variation to add Mycoplasma bovis as a target pathogen.
Slovenian: Imetnik dovoljenja za promet z zdravilom, Intervet International BV, je predložil vlogo za spremembo tipa II, da bi dodali bakterijo Mycoplasma bovis med ciljne patogene.
English: Based on the fact that susceptibility testing for Mycoplasma in animals is not currently standardised (the “true” MIC90 cannot be determined with certainty), that no MIC breakpoint values for Mycoplasma spp.
Slovenian: Glede na dejstvo, da testiranje občutljivosti bakterije Mycoplasma pri živalih trenutno ni standardizirano („prave“ MIK90 ni mogoče zanesljivo določiti), da Inštitut za klinične in laboratorijske standarde (CLSI) ni odobril nobenih mejnih vrednosti MIK za bakterijo Mycoplasma spp.
English: Flunixin is one of the most potent anti-inflammatory substances on the market and exerts important effects on the pathophysiology of M. bovis pneumonia, as well as clinical parameters (quicker decrease in rectal temperature and demeanour score over the first 9 hours compared to florfenicol alone).
Slovenian: Fluniksin je ena najmočnejših protivnetnih učinkovin na trgu in ima pomembne učinke na patofiziologijo pljučnice, ki jo povzroča bakterija M. bovis, ter tudi na klinične parametre (hitrejše znižanje rektalne temperature in ocene sprememb v vedenju v prvih 9 urah v primerjavi s samim florfenikolom).
English: Even if the florfenicol monoproduct which was used as a comparator is not approved for M. bovis infections, it had been shown effective in the M. bovis experimental model performed in 2008.
Slovenian: Čeprav zdravilo, ki vsebuje samo florfenikol in je bilo uporabljeno kot primerjalno zdravilo, ni odobreno za okužbe, ki jih povzroča bakterija M. bovis, se je izkazalo za učinkovito v preskušanju na poskusnem modelu M. bovis, izvedenem leta 2008.
English: Based on the current knowledge on Mycoplasma infections the use of the combination of florfenicol with flunixin will improve the clinical success rate over an antibiotic alone.
Slovenian: Glede na trenutno znanje o okužbah z bakterijo Mycoplasma bo uporaba kombinacije florfenikola in fluniksina izboljšala stopnjo klinične uspešnosti v primerjavi s samim antibiotikom.
English: It cannot be concluded from the data available that the susceptibility of M. bovis has decreased during this period.
Slovenian: Iz razpoložljivih podatkov ni mogoče zaključiti, da se je občutljivost bakterije M. bovis v tem času zmanjšala.
English: It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia.
Slovenian: Zdravilo je indicirano za zdravljenje okužb dihal, ki jih povzročajo bakterije Mannheimia haemolytica, Pasteurella multocida ter Histophilus somni in ki so povezane z zvišano telesno temperaturo.
English: In addition, the marketing authorisation holder had to address the potential for the use of the product against M. bovis to contribute to, or increase the risk of, emergence of antimicrobial resistance.
Slovenian: Poleg tega je moral imetnik dovoljenja za promet z zdravilom odgovoriti tudi na vprašanje, ali bi uporaba zdravila proti bakteriji M. bovis lahko prispevala k tveganju oziroma povečala tveganje za razvoj protimikrobne odpornosti.
English: The tested group was compared to two control groups, one negative control (saline) and a positive control.
Slovenian: Preiskovano skupino so primerjali z dvema kontrolnima skupinama, od tega so v eni uporabili negativno kontrolo (fiziološko raztopino) in v drugi pozitivno kontrolo.
English: Mycoplasma bovis was next with 63 isolates followed by Pasteurella multocida (50 isolates).
Slovenian: Sledili sta bakterija Mycoplasma bovis s 63 izolati in bakterija Pasteurella multocida (50 izolatov).
English: Resflor was shown to be significantly superior over florfenicol alone with higher reduction in pyrexia, lower incidence of depression, and better respiratory score at 6 hours post-treatment.
Slovenian: Zdravilo Resflor se je izkazalo za znatno učinkovitejše od samega florfenikola, saj so zabeležili večje znižanje telesne temperature, manjšo incidenco depresije in boljšo respiratorno oceno 6 ur po zdravljenju.
English: The non-inferiority in success rate of Resflor to tulathromycin was demonstrated on Day 4 and Day 7 since the lower boundary of the 97.5% confidence interval was less than 15%.
Slovenian: Na 4. dan in 7. dan so dokazali tudi najmanj enakovredno stopnjo uspešnosti zdravila Resflor v primerjavi s tulatromicinom, saj je spodnja meja 97,5-odstotnega intervala zaupanja znašala manj kot 15 %.
English: Schering-Plough S.A. 63, Agiou Dimitriou street 17456 Alimos Greece
Slovenian: Schering-Plough S.A. 63, Agiou Dimitriou street 17456 Alimos Grčija
English: Enrolled calves had been sampled on Day 0 prior to treatment by deep, protected pharyngeal swabs.
Slovenian: Vključenim teletom so na 0. dan pred zdravljenjem odvzeli vzorce z globokimi, zaščitenimi brisi žrela.
English: No significant difference could be shown in the cumulative success rate 4 to 10 days after treatment (79.4% with florfenicol alone versus 83.5% with Resflor).
Slovenian: Pomembne razlike v kumulativni stopnji uspešnosti 4 do 10 dni po zdravljenju ni bilo mogoče dokazati (79,4 % pri uporabi samega florfenikola v primerjavi s 83,5 % pri uporabi zdravila Resflor).
English: Quinta da Fonte Edifício Vasco da Gama 19 2770-192 Paço de Arcos Portugal
Slovenian: 2770-192 Paço de Arcos Portugalska
English: The results show that the success rate in both treated groups of this subset (84%) was close to the success rate of the overall population (83.5% in the Resflor group and 79.4% in the florfenicol monoproduct group).
Slovenian: Rezultati kažejo, da je bila stopnja uspešnosti v obeh zdravljenih skupinah te podmnožice (84 %) zelo podobna stopnji uspešnosti pri celotni populaciji (83,5 % v skupini z zdravilom Resflor in 79,4 % v skupini z zdravilom, ki vsebuje samo florfenikol).
English: INN Pharmaceutical form Strength Animal species
Slovenian: INN Farmacevtska oblika Jakost
English: Additionally, calves treated with Resflor had a quicker decrease in fever and demeanour score over the first 9 hours when compared to calves treated with florfenicol alone.
Slovenian: Poleg tega sta se pri teletih, ki so jih zdravili z zdravilom Resflor, hitreje znižali telesna temperatura in ocena sprememb v vedenju v prvih 9 urah kot pri teletih, ki so jih zdravili samo s florfenikolom.
English: The marketing authorisation holder retrospectively re-analysed this study with the subset of cases that tested positive for M. bovis upon enrolment.
Slovenian: Imetnik dovoljenja za promet z zdravilom je izvedel retrospektivno ponovno analizo te študije s podmnožico primerov, pri katerih je bil test za odkrivanje bakterije M. bovis ob vključitvi v študijo pozitiven.
English: The clinical cure rate in the florfenicol group (88.5%) was compared to the tulathromycin group (82%) and significant non-inferiority on Day 7 was confirmed.
Slovenian: Stopnjo klinične ozdravitve v skupini s florfenikolom (88,5 %) so primerjali s skupino s tulatromicinom (82 %) in potrdili, da je bil florfenikol na 7. dan zagotovo najmanj enakovreden.
English: However, it could not be used alone in this study, as this would have given an advantage to the tested product which is a combined product of florfenicol and flunixin.
Slovenian: Vendar tega zdravila v študiji niso mogli uporabiti samega, saj bi v tem primeru preiskovano zdravilo, ki vsebuje kombinacijo florfenikola in fluniksina, imelo prednost.
English: The tested product Resflor was compared to a negative control group (saline) to ensure the internal validity of the trial.
Slovenian: Preiskovano zdravilo Resflor so primerjali s skupino z negativno kontrolo (fiziološko raztopino), da bi zagotovili notranjo veljavnost preskušanja.
English: Intervet Hellas S.A. 63, Agiou Dimitriou street 17456 Alimos Greece
Slovenian: Intervet Hellas S.A. 63, Agiou Dimitriou street 17456 Alimos Grčija
English: The benefit-risk ratio for the addition of M. bovis as a fourth BRD pathogen to the indication of Resflor is considered favourable.
Slovenian: Razmerje med tveganji in koristmi za vključitev bakterije M. bovis kot četrtega patogena, ki povzroča bolezni dihal pri govedu, v indikacijo zdravila Resflor je bilo ocenjeno kot ugodno.
English: MIC data and evolution of resistance of M. bovis towards florfenicol
Slovenian: Podatki o MIK in razvoj odpornosti bakterije M. bovis proti florfenikolu
English: Currently there is no standardised method to determine the minimum inhibitory concentration (MIC) of florfenicol against M. bovis.
Slovenian: Standardizirane metode za določitev minimalne inhibitorne koncentracije (MIK) florfenikola proti bakteriji M. bovis trenutno ni.
English: The clinical benefit of Resflor in the treatment of BRD associated with M. bovis has been demonstrated and no specific risk of antimicrobial resistance or any other kind have been identified with the use of this product.
Slovenian: Klinična korist zdravila Resflor pri zdravljenju bolezni dihal pri govedu, povezanih z bakterijo M. bovis, je bila dokazana, prav tako pa v povezavi z uporabo tega zdravila ni bilo ugotovljeno posebno tveganje za protimikrobno odpornost niti nobena druga vrsta tveganja.
English: The reference product in the positive control group contains tulathromycin and is approved for the treatment and prevention of BRD associated with M. bovis.
Slovenian: Referenčno zdravilo v skupini s pozitivno kontrolo je vsebovalo tulatromicin in je odobreno za zdravljenje in preprečevanje bolezni dihal pri govedu, povezanih z bakterijo M. bovis.
English: M. bovis has been exposed to florfenicol at the exposure rate recommended for Resflor for nearly two decades.
Slovenian: Bakterija M. bovis je bila izpostavljena florfenikolu v skladu s stopnjo izpostavljenosti, ki je za zdravilo Resflor priporočena, skoraj dve desetletji.
English: • the CVMP considered that based on clinical results of the data package (two experimental study and two field trials), the dose and duration of treatment of Resflor in the treatment of BRD associated with M. bovis are appropriate;
Slovenian: • odbor CVMP je menil, da sta glede na klinične rezultate iz dokumentacije (dve eksperimentalni študiji in dve klinični preskušanji) odmerek in trajanje zdravljenja, določena za zdravilo Resflor za zdravljenje bolezni dihal pri govedu, povezanih z bakterijo M. bovis, ustrezna;
English: Intervet Nederland B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: Wim de Koerverstraat 35 5831 AN Boxmeer Nizozemska
English: Another positive control group treated with a florfenicol monoproduct was used, however it should be noted that this product is not approved for the treatment of respiratory infections caused by M. bovis.
Slovenian: Uporabili so tudi skupino s pozitivno kontrolo, ki so jo zdravili z zdravilom, ki vsebuje samo florfenikol, vendar je treba upoštevati, da to zdravilo ni odobreno za zdravljenje okužb dihal, ki jih povzroča bakterija M. bovis.
English: There are too many uncertainties in the PK/PD analysis to justify the dose.
Slovenian: V analizi farmakokinetike/farmakodinamike je preveč nejasnosti, da bi lahko z njo utemeljili odmerek.
English: Mycoplasma bovis has been exposed to florfenicol at the exposure rate recommended for Resflor for nearly two decades.
Slovenian: Bakterija Mycoplasma bovis je bila izpostavljena florfenikolu v skladu s stopnjo izpostavljenosti, ki je za zdravilo Resflor priporočena skoraj dve desetletji.
English: Therefore, a flunixin product was co-administered with the tulathromycin product to ensure comparability of treatment groups.
Slovenian: Zato so skupaj z zdravilom, ki vsebuje tulatromicin, dajali tudi zdravilo, ki vsebuje fluniksin, da bi zagotovili primerljivost skupin, ki so prejemale zdravljenje.