FrancophonIA/ELRC3.0 huggingface dataset:
English: aureus LAMRSA (ST398, spa types t034 and t5210) occurring in rabbits raised intensively for meat production and involving farm workers or their family members5.
Danish: aureus LA-MRSA (ST398, spa type t034 og t5210) i en besætning af kaniner med intensivt opdræt til kødproduktion, hvor medarbejderne på bruget og disses familiemedlemmer var inddraget5.
English: In the 100 mg/ml strength, this indication should be restricted to cattle less than 2 years old.
Danish: For styrken 100 mg/ml bør indikationen begrænses til kalve under 2 år.
English: Do not use in growing horses because of possible deleterious damage on articular cartilage.
Danish: Bør ikke anvendes til heste under opvækst grundet mulig skadelig virkning på ledbrusk.
English: The results of these trials demonstrated good clinical evolution of animals at the tested doses, but microbiological results were not provided or they indicated an incomplete elimination of the pathogen.
Danish: Undersøgelserne viste et godt klinisk forløb ved de testede doser, men mikrobiologiske resultater blev enten ikke oplyst eller viste ufuldstændig elimination af patogenet.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to consider what indications, dosage regimens, duration of treatments and withdrawal periods should be applied to the concerned products for each target species in order to ensure efficacious treatment, consumer safety as well as lower the risk of development of antimicrobial resistance to enrofloxacin taking into account the available data.
Danish: Udvalget for Veterinærlægemidler (CVMP) blev anmodet om ud fra de foreliggende data at tage stilling til, hvilke indikationer, dosisregimer, behandlingsvarigheder og tilbageholdelsestider, der bør finde anvendelse for de berørte produkter for hver måldyreart for at sikre effektiv behandling og forbrugernes sikkerhed samt for at mindske risikoen for udvikling af antimikrobiel resistens over for enrofloxacin.
English: Off-label use, leaves the decision on the posology of use to the veterinary practitioner and bears a potential risk of misuse, thus it could increase the risk for developing antimicrobial resistance.
Danish: Ikke godkendt anvendelse overlader doseringen til den praktiserende dyrlæge og medfører potentiel risiko for forkert brug, hvilket kan øge risikoen for, at der opstår antimikrobiel resistens.
English: As stated in CVMP reflection paper on the use of fluoroquinolones in food producing animalsPrecautions for use in the SPC regarding prudent use guidance6, fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Danish: Som angivet i CVMP's oplæg om anvendelse af fluorquinoloner hos fødevareproducerende dyrForsigtighedsregler vedrørende brugen i produktresuméet vedrørende forsvarlig brug6 bør fluorquinoloner forbeholdes behandling af kliniske tilstande, hvor der har været eller forventes dårlig respons på andre klasser af antimikrobielle stoffer.
English: The CVMP position paper regarding availability of products for minor uses and minor species (EMEA/CVMP/477/03)1 establishes that cattle (dairy and meat animals) and sheep (meat animals) are considered as major food-producing species.
Danish: CVMP's oplæg vedrørende tilgængeligheden af produkter til mindre betydningsfulde anvendelser og mindre betydningsfulde arter (EMEA/CVMP/477/03)1 fastslår, at kvæg (malkekvæg og kødkvæg) og får (slagtedyr) skal betragtes som betydningsfulde fødevareproducerende arter.
English: The high efficacy of enrofloxacin in the MMA-syndrome therapy has been confirmed by meta-analysis and systematic review of 6 clinical and susceptibility studies on MMA/PDS and enrofloxacin from the period 1990 to 1998.
Danish: Enrofloxacins høje effektivitet til behandling af MMA-syndrom bekræftes af metaanalyse og systematisk gennemgang af seks kliniske undersøgelser og følsomhedsundersøgelser vedrørende MMA/PDS og enrofloxacin fra perioden 19901998.
English: Therefore, the veterinarian must be aware of the correct temperature requirements of the respective reptile species and the hydration status of the individual patient.
Danish: Derfor må dyrlægen kende til den korrekte temperatur for den aktuelle krybdyrart, samt til den enkelte patients hydreringsstatus.
English: Data regarding Pasteurella spp.
Danish: Der er sparsomme data vedrørende Pasteurella spp.
English: aureus multi-resistant to several types of antimicrobials are currently documented and (iii) that there can be a transfer of resistant bacteria from animals to humans, involving both consumers and handlers of rabbits.
Danish: aureus med multiresistens over for flere typer antimikrobielle stoffer, og iii) resistente bakterier kan overføres fra dyr til mennesker, både til forbrugere og personer i kontakt med kaniner.
English: In conclusion the Committee can accept this indication considering that it is an injectable formulation, and that necessary restrictions provided in the SPC, together with the withdrawal period, would be in favour of a more adequate use of the veterinary medicinal product in rabbits compared to the use under the cascade.
Danish: Som konklusion kan udvalget godtage denne indikation, eftersom det forhold, at der er tale om et injektionspræparat, og at produktresuméet indeholder de nødvendige begrænsninger samt tilbageholdelsestid, vil fremme en mere hensigtsmæssig anvendelse af dette veterinærlægemiddel hos kaniner end anvendelse med kaskadevirkning.
English: A multi-centric comparative field trial in sows has been provided.
Danish: Der er forelagt en sammenlignende multicenter-feltundersøgelse hos søer.
English: The Committte considered that the differences in excipients, as well as the different concentrations of active substance in the products concerned by this referral, do not affect residue depletion from the administration site in such a manner as would require different withdrawal periods for each formulation.
Danish: Udvalget anså ikke forskellene i hjælpestoffer og koncentration af aktivt stof i produkterne under denne indbringelse for at have en sådan betydning for depletionen af restkoncentrationer fra administrationsstedet, at det er nødvendigt med forskellig tilbageholdelsestid for hver formulering.
English: A field study compared 2 different durations of treatments (5 mg/kg bw for 3 or 5 days), but it did not compare the efficacy against an authorised product with a recognised efficacy for this indication.
Danish: I en feltundersøgelse sammenlignedes to forskellige behandlingsvarigheder (5 mg/kg kropsvægt i 3 eller 5 dage), men virkningen blev ikke sammenlignet med et godkendt produkt med anerkendt virkning ved denne indikation.
English: The presence of the renal portal system in reptiles means it is prudent to administer substances in the front half of the body wherever possible.
Danish: Pga. krybdyrenes portåresystem, er det hensigtsmæssigt at administrere stoffer i den forreste halvdel af kroppen, hvis muligt.
English: Thus, the indications in farm rabbits should be considered as an extrapolation from other data (oral route for farm rabbits and/or pet rabbits with the injectable route).
Danish: Indikationerne til kaninbrug bør derfor betragtes som en ekstrapolation af andre data (oral administration til kaniner i kaninbrug og/eller parenteral administration til kaniner som selskabsdyr).
English: Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Danish: Krydsresistens inden for gruppen af fluoroquinoloner er almindelig.
English: Therefore for the justification of the posology, a PK/PD were taken into account.
Danish: Til begrundelse af doseringen blev der derfor taget hensyn til PK/PD.
English: 220 Avenue de la Recherche 59120 LOOS
Danish: Frankrig Bayer Sante 220 Avenue de la Recherche 59120 LOOS
English: No field studies were submitted to support the indications in goats.
Danish: Der blev ikke forelagt feltundersøgelser til underbygning af indikationerne hos geder.
English: Reptiles are ectothermic, relying on external heat sources to maintain their body temperature at the optimum level for correct function of all body systems.
Danish: Krybdyr er vekselvarmere og afhænger af ydre varmekilder for at opretholde en kropstemperatur, der er optimal for korrekt funktion af alle kroppens organer.
English: In support of the efficacy data, published literature was provided, but, generally, lacking specific data and employing variable posology regimens.
Danish: Til støtte for dataene vedrørende virkning blev der forelagt publiceret litteratur, men hovedsagelig uden specifikke data og med anvendelse af forskellige doseringsregimer.
English: The results of different field studies in piglets with enteritis were summarised.
Danish: Der blev foretaget en sammenfatning af resultaterne af forskellige feltundersøgelser hos smågrise med enteritis.
English: From the results obtained, it was not possible to confirm whether the lower dose (2.5 mg/kg bw) produced cure or improvement in the animals.
Danish: Resultaterne viste ikke, hvorvidt den lave dosis (2,5 mg/kg kropsvægt) frembragte helbredelse eller bedring hos dyrene.
English: Intramuscular administration of enrofloxacin showed to be effective especially in cases of enterotoxaemia.
Danish: Intramuskulær administration af enrofloxacin var effektiv, navnlig i tilfælde med enterotoksæmi.
English: Additionally, the efficacy was demonstrated in several studies conducted in the USA with an arginin formulation of enrofloxacin at a 7.5 mg/kg bw dose.
Danish: Derudover blev virkningen dokumenteret i flere undersøgelser i USA med en arginin-formulering af enrofloxacin i en dosis på 7,5 mg/kg kropsvægt.
English: In addition, a PK/PD analysis was conducted with this pathogen, obtaining values considered as predictive of clinical efficacy.
Danish: Derudover blev der med denne patogen udført en PK/PDanalyse, og de opnåede værdier fandtes at være prædiktive for klinisk virkning.
English: Sheep and goats
Danish: Får og geder
English: All available clinical data referred to pet rabbits only.
Danish: De foreliggende kliniske data vedrørte udelukkende kaniner som selskabsdyr.
English: Taking into account all the documentation provided, the CVMP considered that this indication can be accepted, but in the 50 mg/ml strength it should be stated as “Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of
Danish: I betragtning af al den forelagte dokumentation fandt CVMP, at denne indikation kan godtages, men for styrkerne 50 mg/ml bør den anføres som “behandling af akut mycoplasma-associeret artritis forårsaget af enrofloxacin-følsomme stammer af Mycoplasma bovis”.
English: Thus, it was considered that for consistency the target animal species for both strengths should harmonised to “Sheep” and “Goats”.
Danish: Derfor fandtes måldyrearten for de to styrker at burde harmoniseres til “får” og “geder”.
English: Regarding the indication for treatment of skin and wound infections caused by Staphylococcus aureus, the available data were suggestive of a non-complete bacteriological cure, and no PK/PD data were available.
Danish: For indikationen behandling af hud- og sårinfektioner forårsaget af Staphylococcus aureus tydede de foreliggende data på ikke-fuldstændig bakteriologisk helbredelse, og der forelå ingen PK/PD-data.
English: In order to optimise the dosage and to avoid development of resistance it has been concluded that the dose rate of 2.5 mg/kg bw/day should be deleted for all the indications in cattle.
Danish: For at optimere doseringen og undgå resistensudvikling bør doseringen 2,5 mg/kg kropsvægt/dag slettes fra alle indikationer hos kvæg.
English: (e.g. Staphylococcus aureus) and against Mycoplasma spp.
Danish: (f.eks. Staphylococcus aureus) og over for Mycoplasma spp.
English: In the case of Actinobacillus pleuropneumoniae several references were reviewed with experimental and field studies conducted in piglets and pigs.
Danish: For Actinobacillus pleuropneumoniae blev der gennemgået en række kilder til eksperimentelle undersøgelser og feltundersøgelser hos smågrise og grise.
English: Antimicrobial resistance in target pathogens
Danish: Antimikrobiel resistens af målpatogenerne
English: If necessary, depending on the severity of clinical signs, this dosage can be doubled.
Danish: Afhængig af de kliniske symptomer, kan dosis om nødvendigt fordobles.
English: A dose-confirmation study and a field study showed clinical efficacy of the dose of 5 mg/kg bw/day against enzootic pneumonia caused by M. haemolytica and P. multocida.
Danish: En undersøgelse til dosisfastlæggelse og en feltundersøgelse viste klinisk virkning af dosen 5 mg/kg kropsvægt/dag mod enzootisk pneumoni forårsaget af M. haemolytica og P. multocida.
English: Regarding target species dog and cat, data submitted show an increase in resistance rates of non enteric E. coli and Staphylococcus spp.
Danish: For måldyrearterne hund og kat viser de forelagte data fra isolater, der er testet i Tyskland, en stigning i resistensraterne af ikke-enteriske E. coli og Staphylococcus spp.
English: A second dose-titration trial was conducted in Japan with natural infection caused by E. coli in suckling piglets.
Danish: Der blev foretaget endnu en dosistitreringsundersøgelse i Japan med naturlig infektion forårsaget af E. coli hos spædgrise.
English: Intestinal bacterial counts were significantly reduced by treatment with 2.5 mg/kg bw/day.
Danish: Det intestinale bakterietal blev reduceret væsentligt ved behandling med 2,5 mg/kg kropsvægt/dag.
English: Laboratorios Dr. Esteve, S.A. Avda.
Danish: Spanien Laboratorios Dr. Esteve, S.A. Avda.
English: In the field study, calves (from 15 kg to 150 kg bw) with naturally occurring gastrointestinal infections due to E.coli, were treated every day with enrofloxacin either orally, by a parenteral (intramuscular, subcutaneous or intravenous) route followed by oral, or only parenteral route.
Danish: I feltundersøgelsen blev kalve (15-150 kg kropsvægt) med naturligt forekommende mave-tarm-infektion forårsaget af E.coli behandlet dagligt med enrofloxacin, der enten blev givet oralt, parenteralt (intramuskulært, subkutant eller intravenøst) efterfulgt af oralt eller parenteralt alene.
English: However, several experimental controlled studies were conducted employing both 2.5 and 5 mg/kg body weight (bw) parenteral doses, but more consistent data on the higher dose were presented.
Danish: Der blev imidlertid foretaget en række kontrollerede undersøgelser, hvor de to parenterale doser 2,5 og 5 mg/kg kropsvægt blev anvendt, men data for den højere dosis var mere samstemmende.
English: The latter also applies for alimentary tract infections and septicaemia caused by E. coli in pigs.
Danish: Dette gælder også mave-tarm-infektioner og septikæmi forårsaget af E. coli hos svin.
English: The authors concluded that resistance to antimicrobial agents in Staph.
Danish: Forfatterne konkluderede, at antibiotikaresistens hos isolater af Staph.
English: Treatment may be initiated with injectable product and maintained with enrofloxacin tablets.
Danish: Behandlingen kan indledes med injektionspræparatet og fortsætte med enrofloxacin-tabletter.
English: Enrofloxacin is reported to have deleterious effect on articular cartilage in growing horses.
Danish: Enrofloxacin beskrives at have ødelæggende virkning på ledbrusken hos heste i opvækst.
English: To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre korrekt dosering og undgå underdosering bør kropsvægten fastslås så nøjagtigt som muligt.
English: A field study showed the efficacy of the proposed dose comparing it with a reference product containing cefquinome.
Danish: Virkningen af den ansøgte dosis blev påvist i en feltundersøgelse ved sammenligning med et referenceprodukt indeholdende cefquinom.
English: Duration of treatment should be based on the duration of treatment approved for the appropriate indication in the product information of the tablet product.
Danish: Behandlingsperioden bør baseres på den behandlingsperiode, som er godkendt for tabletpræparatet og den aktuelle indikation angivet i produktinformationen.
English: The data show that, in general, high susceptibility to enrofloxacin is observed among the majority of strains of bovine and porcine respiratory pathogens as well as non-enteric E. coli.
Danish: De viser, at der generelt ses høj følsomhed over for enrofloxacin i størstedelen af de luftvejspatogene stammer hos kvæg og svin samt i ikke-enteriske E. coli.
English: It is therefore appropriate to derive a single harmonised withdrawal period based on the totality of residue data from all formulation groups.
Danish: Det er derfor hensigtsmæssigt at udlede en enkelt harmoniseret tilbageholdelsestid baseret på samtlige restkoncentrationsdata fra alle grupper af formuleringer.
English: From the overall data provided by the MAHs (efficacy data, PK/PD and target pathogens resistance), it can be concluded that the dose of 2.5 mg/kg bw/day (even showing a relatively good clinical response in some cases) may not allow complete elimination of bacteria and it could lead to resistance development against E. coli.
Danish: De data, der er forelagt af indehaverne af markedsføringstilladelse (kliniske, farmakokinetiske/farmakodynamiske data samt resistensdata hos målpatogener), viser samlet, at dosen 2,5 mg/kg kropsvægt/dag (selv om den i visse tilfælde viser god klinisk respons) muligvis ikke tillader fuldstændig elimination af bakterierne og kan tænkes at medføre øget resistensudvikling over for E. coli.
English: Treatment with enrofloxacin significantly reduced the incidence and severity of diarrhoea.
Danish: Behandling med enrofloxacin nedsætter væsentligt forekomst og sværhed af diarré.
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Danish: Enrofloxacin er et syntetisk kemoterapeutikum i klassen carboxylsyrederivater af fluorquinolon.
English: • on the basis of the available data, the CVMP considered that indications as provided in Annex III
Danish: • CVMP fandt indikationerne i henhold til bilag i III velbegrundede ud fra de foreliggende data
English: All residues were below the MRLs at 5 days.
Danish: Alle restkoncentrationer var under maksimalgrænseværdierne ved 5 dage.
English: In another study piglets were challenged with E. coli and displayed signs of diarrhoea and enterotoxaemia.
Danish: I en anden undersøgelse blev smågrise belastet med E. coli og viste tegn på diarré og enterotoksæmi.
English: in the last years: bovine: 45 to 86%; porcine: 4% to 27%.
Danish: I de seneste år er der fundet moderate til høje resistensrater af Campylobacter spp., nemlig 45 til 86 % hos kvæg og 4 til 27 % hos svin.
English: An enrofloxacin intramuscular injection at 2.5 mg/kg bw, administered once daily until the clinical signs of respiratory disease decreased, resulted in a 94.5% success rate.
Danish: Enrofloxacin, 2,5 mg/kg kropsvægt intramuskulært én gang dagligt indtil aftagen af kliniske tegn på luftvejssygdom, medførte en succesrate på 94,5 %.
English: Meat and offal (50 mg/ml and 100 mg/ml strengths): In line with the CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)9, in relation to identical products the withdrawal period established for a major ruminant species may be extrapolated to a minor ruminant species applying a safety span of 1.5 where there is the potential for local residues.
Danish: Kød og indmad (styrkerne 50 mg/ml og 100 mg/ml): I overensstemmelse med CVMP's retningslinjer om sikkerhedskrav og restkoncentrationsdata for veterinærlægemidler bestemt til mindre betydningsfuld anvendelse eller mindre betydningsfulde arter (EMEA/CVMP/SWP/66781/2005)9 kan der for identiske produkter anvendes ekstrapolation af en tilbageholdelsestid for en mere betydningsfuld til en mindre betydningsfuld drøvtyggerart, idet der anvendes en sikkerhedsmargin på 1,5, når der er potentiale for lokale rester.
English: Belgium Bayer SA-NV J.E.
Danish: Belgien Bayer SA-NV J.E.
English: Milk (100 mg/ml strength): Only one residue depletion study in cattle milk was considered adequate for the purpose of setting a withdrawal period in milk.
Danish: Mælk (styrken 100 mg/ml): Kun én restkoncentrationsundersøgelse i komælk blev anset for egnet til fastsættelse af en tilbageholdelsestid for mælk.
English: Replication forks and translational complexes cannot proceed beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and mRNA synthesis triggers events resulting in a rapid, drug concentration-dependent killing of pathogenic bacteria.
Danish: Kløvning af dna-streng under replikation samt translationskomplekser kan ikke passere sådanne enzym-dna-fluoroquinolon-komplekser og inhibering af dna- og mrna-syntesen udløser et forløb, som resulterer i et hurtig, dosisafhængigt drab af patogene bakterier.
English: Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins.
Danish: Resistens over for fluoroquinoloner er rapporteret at have fem årsager, (i) punktmutationer i gener, der koder for dna-gyrase og/eller topoisimerase IV, hvilket fører til ændring af det respektive enzym, (ii) ændringer i permabiliteten for lægemidlet i gram-negative bakterier, (iii) efflux-mekanismer, (iv) plasmid båren resistens og (v) proteiner der beskytter gyrase.
English: Confirmatory field trials showed clinical efficacy of the dose of 5 mg/kg bw/day rather than the lower dose.
Danish: Bekræftende feltundersøgelser viste i højere grad klinisk virkning af dosen 5 mg/kg kropsvægt/dag end af den lavere dosis.
English: Lublin Poland
Danish: Lublin Polen
English: Bielawa Poland
Danish: Bielawa Polen
English: In order to compensate for the biological uncertainties and the variability of the data, a safety span of 30% was used, resulting in a withdrawal period of 13 days.
Danish: For at kompensere for biologiske usikkerheder og datavariabilitet blev der tillagt en sikkerhedsmargin på 30 %, hvilket resulterede i en tilbageholdelsestid på 13 dage.
English: Antimicrobial resistance in food borne bacteria
Danish: Antimikrobiel resistens af fødevarebårne bakterier
English: The first time point where all residues were below the MRLs, in both studies, was 3 days post-treatment.
Danish: Det første tidspunkt, hvor alle restkoncentrationer var under maksimalgrænseværdien i begge undersøgelser, var 3 dage efter behandlingen.
English: A dose of 2.5 mg/kg bw/day intramuscularly for 1 or 3 days was tested comparing with oral administration.
Danish: 2,5 mg/kg kropsvægt/dag intramuskulært i 1-3 dage blev sammenlignet med oral administration.
English: Therefore PK/PD and resistance data were taken into account when considering the efficacy of enrofloxacin against Mycoplasma spp.
Danish: Der blev derfor taget hensyn til PK/PD-data og resistensdata ved vurderingen af enrofloxacins virkning mod Mycoplasma spp.
English: In these studies different doses were administered (overall range 1-6 mg/kg bw/day) and the study design did not allow evaluating the efficacy of each dose individually.
Danish: I undersøgelserne anvendtes forskellige doser (samlet område 1-6 mg/kg kropsvægt/dag), men virkningen af hver dosis kunne ikke vurderes hver for sig på grund af undersøgelsens design.
English: In order to compensate for the biological uncertainties and the variability of the data, a safety span of 30% was used, resulting in a withdrawal period of 12 days.
Danish: For at kompensere for biologiske usikkerheder og datavariabilitet blev der tillagt en sikkerhedsmargin på 30 %, hvilket resulterede i en tilbageholdelsestid på 12 dage.
English: Only few data have been submitted by the MAHs regarding resistance in food borne bacteria.
Danish: Indehaverne af markedsføringstilladelse har kun forelagt få data om resistens af fødevarebårne bakterier.