FrancophonIA/ELRC3.0 huggingface dataset:
English: By the end of the study (Day 18), 61 of 87 cases (70.1%) were successfully treated with florfenicol compared to 68 out of 89 cases (76.4%) treated with tulathromycin.
Croatian: Do završetka ispitivanja (18. dana ), 61 od 87 slučajeva (70,1%) bilo je uspješno liječeno florfenikolom u usporedbi sa 68 od 89 slučajeva (76,4%) liječenih tulatromicinom.
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%.
Croatian: Neinferiornost u stopi uspješnosti VMP-a Resflor u odnosu na tulatromicin dokazana je 4. i 7. dana budući da su donje granice intervala pouzdanosti od 97,5% bile niže od 15%.
English: However, any use of antibiotic will lead to increase of resistance and therefore, prudent use should always be recommended.
Croatian: No, bilo koja uporaba antibiotika rezultirat će povećanjem rezistencije i stoga se uvijek preporuča razumna uporaba.
English: The antipyretic response to tulathromycin or florfenicol treatment was clinically similar with statistically significant differences in favour of florfenicol on Days 2 and 3.
Croatian: Antipiretijski odgovor na terapiju tulatromicinorom florfenikolom bio je klinički sličan statistički značajnim razlikama u korist florfenikolona 2. i 3. dana.
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.
Croatian: No, nije se mogao koristiti kao monoterapija u ovom ispitivanju jer bi to omogućilo prednost testiranom proizvodu koji je kombinirani proizvod florfenikola i fluniksina.
English: The final outcome and the risk for relapse was assessed when the antimicrobial effect of Resflor has ceased.
Croatian: Konačni ishod i rizik od relapsa ocijenjen je nakon što je antimikrobsko djelovanje VMP-a Resflor završeno.
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
Croatian: Djelotvornost VMP-a Resflor protiv infekcija dišnih putova uzrokovanih bakterijom M. bovis dokazana je u dva eksperimentalna modela (provedena 2008. i 2012.), te dva klinička terenska ispitivanja (provedena 2004. i 2005.).
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.
Croatian: Kako bi se riješila pitanja sigurne primjene koja su postavile Danska i Njemačka, od nositelja odobrenja zatraženo je da dostavi sve dostupne podatke o djelotvornosti za VMP Resflor, popraćene obrazloženjem za preporučenu terapijsku dozu i primjerenost dizajna ispitivanja za pivotalno ispitivanje testa provedeno 2012.
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.
Croatian: Tijekom postupka izmjene u Koordinacijskoj skupini za postupak međusobnog priznavanja i decentralizirani postupak za veterinarsko-medicinske proizvode (CMDv), Danska i Njemačka identificirale su potencijalno ozbiljan rizik za zdravlje životinja u vezi s demonstracijom djelovanja u kliničkim ispitivanjima i obrazloženjem preporučene terapijske doze za VMP Resflor za potrebe liječenja infekcija dišnih putova uzrokovanih bakterijom Mycoplasma bovis, što se može povezati s povećanim rizikom od razvoja rezistencije na antimikrobik.
English: No further risk management or mitigation measures are required as a consequence of this referral procedure.
Croatian: Daljnje upravljanje rizikom ili mjere za smanjivanje rizika potrebne su samo kao posljedica postupka upućivanja.
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.
Croatian: Bez obzira na to, na temelju podataka prikupljenih izvankliničkim ispitivanjima koje je dostavio nositelj odobrenja za stavljanje VMP-a u promet, MIK-ovi za florfenikol protiv sojeva M. bovis izoliranih u nekoliko država članica u razdoblju od 2007. do 2013. kretali su se u rasponu od 0,5 do >64 µg/ml.
English: It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia.
Croatian: Indiciran je za liječenje infekcija dišnih putova uzrokovanih bakterijama Mannheimiahaemolytica, Pasteurellamultocida i Histophilussomni povezanima s pireksijom.
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).
Croatian: Stopa uspješnosti 4. i 7. dana (primarne završne točke) bila je znatno viša u skupini koja je primala VMP Resflor nego u skupini koja je primala otopinu (4. dan: Resflor 96,9% u odnosu na fiziološku otopinu 61,9%; 7. dan: Resflor 92,2% u odnosu na fiziološku otopinu 47,6%; p<0.0001 - Fischerov test točnosti).
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.
Croatian: Na temelju aktualnih saznanja o infekcijama uzrokovanima bakterijom Mycoplasma, uporaba kombinacije florfenikola s fluniksinom poboljšat će kliničke stope uspješnosti u odnosu na primjenu samo antibiotika.
English: The marketing authorisation holder Intervet International BV, submitted an application for a type II variation to add Mycoplasma bovis as a target pathogen.
Croatian: Intervet International BV, nositelj odobrenja za stavljanje VMP-a u promet, dostavio je zahtjev za izmjenu tipa II kako bi se dodao Mycoplasma bovis kao ciljni patogen.
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.
Croatian: Stopa kliničkog izliječenja u skupini koja je primala florfenikol (88,5%) uspoređena je sa skupinom koja je primala tulatromicin (82%), te je potvrđena značajna neinferiornost 7. dana.
English: MIC data and evolution of resistance of M. bovis towards florfenicol
Croatian: MIK podaci i evolucija rezistencije bakterije M. bovis na florfenikol
English: Currently there is no standardised method to determine the minimum inhibitory concentration (MIC) of florfenicol against M. bovis.
Croatian: Trenutno ne postoji standardizirana metoda za utvrđivanje minimalne inhibitorne koncentracije (MIK-a) za florfenikol protiv bakterije M. bovis.
English: The pivotal challenge model performed in 2012 was randomised, blinded and GCP compliant.
Croatian: Pivotalni model testiranja proveden 2012. bio je randomiziran, slijep i sukladan s DKP-om.
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.
Croatian: Odobrenje za stavljanje u promet florfenikola za liječenje bolesti dišnih putova uzrokovane bakterijom M. bovis izbjeglo bi primjenu kritički važnih antimikrobika te bi posljedično moglo smanjiti pritisak selekcije za pojavu rezistentnih sojeva iz primjene drugih kategorija antibiotika poput makrolida i fluorokvinolona.
English: Soseua de Centura no. 13A Comuna Chiajna Judet Ilfov
Croatian: Comuna Chiajna Judet Ilfov
English: Enrolled calves had been sampled on Day 0 prior to treatment by deep, protected pharyngeal swabs.
Croatian: Upisana telad je uzorkovana 0. dana prije liječenja dubokim, zaštićenim brisom jednjaka.
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).
Croatian: Fluniksin je jedan od najjačih protuupalnih lijekova dostupnih na tržištu i ima važno djelovanje na patofiziologiju upale pluća uzrokovane bakterijom M. bovis, kao i kliničke parametre (brže smanjivanje rektalne temperature i rezultat ponašanja tijekom prvih 9 sati u usporedbi samo s florfenikolom).
English: There is little information on how pharmacokinetic and pharmacodynamic data should be applied in the treatment of M. bovis infections.
Croatian: Dostupno je malo informacija o načinu primjene farmakokinetičkih i farmakodinamičkih podataka u slučaju liječenja infekcija bakterijom M. bovis.
English: The marketing authorisation holder retrospectively re-analysed this study with the subset of cases that tested positive for M. bovis upon enrolment.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet retrospektivno je proveo ponovnu analizu ovog ispitivanja s podskupom slučajeva koji su pozitivno testirani na bakteriju M. bovis nakon upisa.
English: Intervet MSD Santé Animale 7 Rue Olivier de Serres Angers Technopole CS 17144
Croatian: 7 Rue Olivier de Serres Angers Technopole CS 17144
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.
Croatian: Čak i u slučaju da VMP koji sadrži samo florfenikol, a koristi se kao komparator, ne bude odobren za infekcije uzrokovane bakterijom M. bovis, u eksperimentalnom modelu za bakteriju M. bovis provedenom 2008. dokazano je da je djelotvoran.
English: Schering-Plough S.A. 63, Agiou Dimitriou street 17456 Alimos Greece
Croatian: Schering-Plough S.A. 63, Agiou Dimitriou street 17456 Alimos Grčka
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.
Croatian: Referentni VMP u pozitivnoj kontrolnoj skupini sadržavao je stulatromicin i odobren je za liječenje i prevenciju BRD-a povezanog s M. bovis.
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.
Croatian: Dokazano je da je Resflor značajno superiorniji u odnosu na monoterapiju florfenikolom s većom stopom redukcije u pireksiji, manjom incidencijom depresije i boljim respiratornim vrijednostima 6 sati nakon liječenja.
English: The tested product Resflor was compared to a negative control group (saline) to ensure the internal validity of the trial.
Croatian: Testirani VMP Resflor uspoređen je s negativnom kontrolnom skupinom (otopina) kako bi se osigurala interna valjanost ispitivanja.
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.
Croatian: Nadalje, nositelj odobrenja za stavljanje VMP-a u promet trebao je istražiti potencijalnu uporabu proizvoda protiv bakterije M. bovis koja doprinosi riziku ili povećava rizik pojave rezistencije na antimikrobik.
English: D-85716 Unterschleißheim Germany
Croatian: Feldstraße 1a D-85716 Unterschleißheim Njemačka
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).
Croatian: Rezultati su pokazali da stopa uspjeha u obje tretirane skupine ovog podskupa (84%) je bila blizu stope uspjeha cjelokupne populacije (83,5% za skupinu koja je primala VMP Resflor i 79,4% za skupinu koja je primala VMP koji sadrži samo florfenikol).
English: Intervet Hellas S.A. 63, Agiou Dimitriou street 17456 Alimos Greece
Croatian: Intervet Hellas S.A. 63, Agiou Dimitriou street 17456 Alimos Grčka
English: The study confirmed the superiority of Resflor to placebo (saline) for the treatment of M. bovis-induced bovine respiratory disease (BRD).
Croatian: Ispitivanje je potvrdilo superiornost VMP-a Resflor u odnosu na placebo (otopinu) za liječenje bolesti dišnih putova uzrokovanih bakterijom M.bovis u goveda (BRD).
English: The multicentre trial performed in 2005 compared the efficacy of the florfenicol monoproduct to tulathromycin in naturally occurring outbreaks of BRD.
Croatian: Multicentrično ispitivanje provedeno 2005. usporedilo je djelotvornost VMP-a koji sadrži samo florfenikol u odnosu na tulatromicin u slučaju izbijanja BRD-a koji se prirodno pojavljuju.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje VMP-a u promet
English: As only the florfenicol-monoproduct was tested, the antimicrobial effect of florfenicol could be compared with the one of tulathromycin only.
Croatian: Budući da je testiran samo VMP koji je sadržavao florfenikol, antimikrobijsko djelovanje florfenikola moglo se usporediti samo s onim tulatromicina.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Croatian: Valjani sažetak opisa svojstava VMP-a, etiketa i uputa za uporabu ostaju u skladu s konačnim verzijama usuglašenima tijekom postupka provedenog od strane Koordinacijske skupine.
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.
Croatian: Dokazana je klinička korist VMP-a Resflor u liječenju BRD-a povezanog s bakterijom M. bovis i niti jedan specifičan rizik antimikrobne rezistencije ili druge vrste nije utvrđen za ovaj VMP.
English: Resflor is therefore considered superior to the saline treatment and non-inferior to the combination tulathromycin-flunixin.
Croatian: Stoga se Resflor smatra superiornim u odnosu na liječenje fiziološkom otopinom i neinferioran u odnosu na kombinaciju tulatromicina i fluniksina.
English: Intervet Nederland B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands
Croatian: Wim de Koerverstraat 35 5831 AN Boxmeer Nizozemska
English: Resflor solution injectable (thereafter called ‘Resflor') is a solution for injection for use in cattle containing florfenicol and flunixin as active substances.
Croatian: Resflor injektibilna otopina (u daljnjem tekstu ‘Resflor') je otopina za injekciju koja sadrži fluorfenikol i fluniksin kao djelatne tvari za primjenu u goveda.
English: The field trial study performed in 2004 was a GCP study comparing a florfenicol monoproduct (40 mg/kg) and Resflor administered as a single subcutaneous dose for the treatment of bovine respiratory disease.
Croatian: Terensko ispitivanje provedeno 2004. bilo je ispitivanje DKP-a koje je usporedilo VMP koji sadrži samo florfenikol (40 mg/kg) i VMP Resflor primijenjen kao jedna potkožna doza za liječenje bolesti dišnih putova u goveda.
English: Therefore, the justification of the recommended treatment dose of a single injection of 40 mg florfenicol and 2.2 mg flunixin per kg bw for the treatment of BRD associated with M. bovis is based on the clinical data.
Croatian: Stoga se opravdanost preporučene doze za liječenje od jedne injekcije 40 mg florfenikola i 2,2 mg fluniksina po kg tt za liječenje BRD-a povezanog s bakterijom M. bovis temelji na kliničkim podacima.
English: Overall summary of the scientific evaluation of Resflor solution injectable and associated names (see annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene VMP-a Resflor injekcijsku otopinu i povezane nazive (vidjeti Dodatak I)
English: It cannot be concluded from the data available that the susceptibility of M. bovis has decreased during this period.
Croatian: Iz dostupnih podataka ne može se zaključiti da se osjetljivost bakterije M. bovis smanjila tijekom ovog razdoblja.
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).
Croatian: U kumulativnoj stopi uspjeha 4 do 10 dana nakon liječenja nije uočena značajna razlika (79,4% s monoterapijom florfenikol u odnosu na 83,5% s VMP-om Resflor).
English: A single subcutaneous injection of 40 mg florfenicol and 2.2 mg flunixin per kg body weight (bw) is recommended (2 ml/15 kg bw).
Croatian: Preporučena je jedna potkožna injekcija od 40 mg florfenikola i 2,2 mg fluniksina po kg tjelesne težine (tt) (2 ml/15 kg tt).
English: M. bovis has been exposed to florfenicol at the exposure rate recommended for Resflor for nearly two decades.
Croatian: M. bovis je izložen florfenikolu uz stopu izlaganja preporučenu za VMP Resflor tijekom razdoblja od gotovo dva desetljeća.
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.
Croatian: Nadalje, u teladi liječene VMP-om Resflor zabilježeno je brže smanjivanje vrućice i vrijednosti ponašanja tijekom prvih 9 sati u usporedbi s teladi liječenom monoterapijom florfenikolom.
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.
Croatian: Druga pozitivna kontrolna skupina tretirana je florfenikolom kao mono VMP-om, no potrebno je napomenuti da ovaj VMP nije odobren za liječenje infekcija dišnih putova uzrokovanih bakterijom M.bovis.
English: Mycoplasma bovis has been exposed to florfenicol at the exposure rate recommended for Resflor for nearly two decades.
Croatian: Mycoplasma bovis bio je izložen florfenikolu uz stopu izlaganja preporučenu za VMP Resflor tijekom razdoblja od gotovo dva desetljeća.
English: Based on the absence of standardised method to determine the MIC, it is difficult to follow resistance evolution of M. bovis toward florfenicol.
Croatian: Temeljem nepostojanja standardizirane metode za utvrđivanje MIK-a, teško je slijediti kretanje rezistencije bakterije M. bovis na florfenikol.
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.
Croatian: Temeljem činjenice da testiranje osjetljivosti za Mycoplasma u životinja nije trenutno standardizirano (“istiniti” MIC90 ne može se utvrditi sa sigurnošću), da nisu odobrene vrijednosti za točke promjene za MIK za Mycoplasma spp. od strane Instituta za kliničke i laboratorijske standarde (CLSI) te da nema dobro utvrđenog farmakokinetičkog/ farmakodinamičkog (FK/FD) odnosa, ne mogu se donijeti zaključci o predvidivoj djelotvornosti pristupa.
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;
Croatian: • na temelju kliničkih rezultata skupa podataka (dva eksperimentalna ispitivanja i dva terenska ispitivanja), CVMP je zaključio da su doza i trajanje liječenja VMP-om Resflor u liječenju BRD-a povezanog s M. bovis odgovarajući;
English: The benefit-risk ratio for the addition of M. bovis as a fourth BRD pathogen to the indication of Resflor is considered favourable.
Croatian: Omjer koristi i rizika za dodavanje bakterije M. bovis kao četvrtog patogena BRD-a uz indikaciju VMP-a Resflor smatra se povoljnim.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Croatian: Dopune relevantnih odjeljaka opisa sažetka svojstava, etikete i upute o lijeku
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
Croatian: Budući da referentna država članica i države članice u postupku nisu uspjele postići dogovor u vezi s izmjenom, dana 24. siječnja 2014.
English: This study demonstrated the efficacy of Resflor in the treatment of BRD associated with major pathogens.
Croatian: Ispitivanjem je dokazana djelotvornost VMP-a Resflor za liječenje BRD-a povezanog s glavnim patogenima.
English: Polígono Industrial El Montalvo I c/Zeppelín n° 6, parcela 38 37008 Carbajosa de la Sagrada - Salamanca Spain
Croatian: Polígono Industrial El Montalvo I c/Zeppelín n° 6, parcela
English: Therefore, the trial also showed the therapeutic benefit of using a fixed combination of 40 mg florfenicol and 2.2 mg flunixin per kg bw (Resflor) compared to 40 mg florfenicol per kg bw alone.
Croatian: Stoga, ispitivanjem su također utvrđene terapijske koristi primjene fiksne kombinacije 40 mg florfenikola i 2,2 mg fluniksina po kg tt (Resflor) u usporedbi s monoterapijom od 40 mg florfenikola po kg tt.
English: Therefore, a flunixin product was co-administered with the tulathromycin product to ensure comparability of treatment groups.
Croatian: Stoga je VMP koji sadrži fluniksin primijenjen zajedno sa VMP-om koji sadrži tulatromicin kako bi se osigurala usporedivost skupina za liječenje.
English: Grounds for the variation to the terms of the marketing authorisations
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje VMP-a u promet
English: From the data currently available, no particular risk of increase of M. bovis susceptibility to florfenicol is expected from the use of Resflor.
Croatian: U slučaju trenutno dostupnih podataka ne očekuje se poseban rizik od povećanja osjetljivosti bakterije M. bovis na florfenikol uslijed uporabe VMP-a Resflor.
English: No particular risk of increase of M. bovis susceptibility to florfenicol is expected from the use of Resflor at the recommended dose.
Croatian: Ne očekuje se poseban rizik od povećanja osjetljivosti bakterije M. bovis na florfenikol uslijed primjene VMP-a Resflor u preporučenoj dozi.
English: The two experimental studies and the retrospective analyses on field trials show that the recommended dose and duration of treatment of Resflor is adequate for the treatment of BRD associated with M. bovis.
Croatian: Dva eksperimentalna ispitivanja i retrospektivne analize terenskih istraživanja pokazali su da je preporučena doza i trajanje liječenja VMP-a Resflor primjereno za liječenje BRD-a povezanog s bakterijom M. bovis.
English: the CVMP concluded that the overall benefit-risk balance is positive and recommended the granting of the variation to the terms of the marketing authorisation for Resflor solution injectable (see annex I)
Croatian: CVMP je zaključio da je cjelokupan omjer koristi i rizika pozitivan i preporučio je odobravanje izmjena uvjeta odobrenja za stavljanje u promet VMP-a Resflor injektibilne otopine (vidjeti Dodatak I) za koje valjani sažetak opisa svojstava VMP-a, etiketa i uputa za uporabu ostaju u skladu s konačnim verzijama usuglašenima tijekom postupka provedenog od strane Koordinacijske skupine, kako je navedeno u Dodatku III.