Примери за използване на Resflor на Английски и техните преводи на Български
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This study demonstrated the efficacy of Resflor in the treatment of BRD associated with major pathogens.
No particular risk of decrease of M. bovis susceptibility to florfenicol is expected from the use of Resflor.
Overall summary of the scientific evaluation of Resflor solution injectable and associated names(see annex I).
Resflor is a solution for injection for use in cattle containing florfenicol and flunixin as active ingredients.
Bovis has been exposed to florfenicol at the exposure rate recommended for Resflor for nearly two decades.
Resflor is therefore considered superior to the saline treatment and non-inferior to the combination tulathromycin-flunixin.
The benefit-risk ratio for the addition of M. bovis as a fourth BRD pathogen to the indication of Resflor is considered favourable.
The tested product Resflor was compared to a negative control group(saline) to ensure the internal validity of the trial.
No particular risk of increase of M. bovis susceptibility to florfenicol is expected from the use of Resflor at the recommended dose.
The study confirmed the superiority of Resflor to placebo(saline) for the treatment of M. bovis-induced bovine respiratory disease(BRD).
From the data currently available, no particular risk of increase of M. bovis susceptibility to florfenicol is expected from the use of Resflor.
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%.
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).
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.
The CVMP concluded that the overall benefit-risk balance is positive andrecommended the granting of the variation to the terms of the marketing authorisation for Resflor solution injectable(see annex I).
Resflor solution injectable(thereafter called‘Resflor') is a solution for injection for use in cattle containing florfenicol and flunixin as active substances.
Therefore, the trial also showed the therapeutic benefit of using a fixed combination of 40 mg florfenicol and2.2 mg flunixin per kg bw(Resflor) compared to 40 mg florfenicol per kg bw alone.
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.
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.
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.
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).
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.
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 andthe 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.
The CVMP concluded that the clinical benefit of Resflor in the treatment of respiratory infections associated with M. bovis has been demonstrated and no specific risk of antimicrobial resistance has been identified with the use of this product.
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).