FrancophonIA/ELRC3.0 huggingface dataset:
English: D-88326 Aulendorf Germany
Danish: D-88326 Aulendorf Tyskland
English: aureus isolates originating from other animals and humans.
Danish: aureus fra andre dyr eller mennesker.
English: The respiratory indications were extrapolated from the ones existing in cattle.
Danish: Luftvejsindikationerne blev ekstrapoleret fra de eksisterende indikationer hos kvæg.
English: The provided data on efficacy are adequate to demonstrate efficacy against this bacteria.
Danish: De forelagte data om virkning er tilstrækkelige til at godtgøre virkningen mod denne bakterie.
English: Fluoroquinolones represent a class of antimicrobials which is critically important in the treatment of severe and invasive infections in humans and animals and are therefore of special interest for public and animal health.
Danish: Fluorquinoloner er en klasse af antimikrobielle stoffer, der er kritisk vigtige til behandling af svære og invasive infektioner hos mennesker og dyr, og som derfor er af særlig interesse med hensyn til menneskers og dyrs sundhed.
English: Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia
Danish: Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenien
English: The 2012 RESAPATH annual report indicated that more than 90% of Pasteurella in goats are sensitive to enrofloxacin.
Danish: RESAPATH-årsberetningen for 2012 viste, at mere end 90 % af Pasteurella hos geder er følsomme for enrofloxacin.
English: Litvínovská 609/3 190 21 Praha 9
Danish: Litvínovská 609/3 190 21 Praha 9 Tjekkiet
English: Finally, resistance to ciprofloxacin in Enterococcus bacteria varied from 0 to 29% in cattle and from 0 to 33% in pigs.
Danish: Endelig varierede resistensen over for ciprofloxacin hos Enterococcus fra 0 til 29 % hos kvæg og fra 0 til 33 % hos svin.
English: The results from an experimental study and a field study were provided.
Danish: Der forelå resultater af en eksperimentel undersøgelse og en feltundersøgelse.
English: The withdrawal period was statistically calculated by means of the TTSC method (i.e. where residues in all animals fall below the level considered safe within the time span for which data are available) resulting in 5.6 milkings / 3 days.
Danish: Tilbageholdelsestiden blev beregnet statistisk ved hjælp af TTSC-metoden (hvor restkoncentrationerne for alle dyr kommer under det sikre niveau inden for den periode, der er omfattet af data), hvilket resulterede i 5,6 malkninger/3 dage.
English: Germany Serumwerk Bernburg AG Hallesche Landstr.
Danish: Tyskland Serumwerk Bernburg AG Hallesche Landstr.
English: At the European level, different actions and activities are constantly taken in order to maintain the efficacy of fluoroquinolone-containing veterinary medicinal products.
Danish: På europæisk plan bliver der løbende truffet en række tiltag og iværksat aktiviteter for at bevare virkningen af veterinærlægemidler indeholdende fluorquinoloner.
English: On the other hand, no resistance or very low resistance rates were observed for bacteria causing mastitis in ruminants (E. coli, Staph.
Danish: På den anden side sås der ingen eller kun meget lave resistensrater for bakterier, der er årsag til mastitis hos drøvtyggere (E. coli, Staph.
English: Cure or improvement was observed in 85% to 90% of animals treated by enrofloxacin, the best results being obtained when parenteral administration is followed by oral administration.
Danish: Der blev iagttaget helbredelse eller bedring hos 85-90 % af de dyr, der blev behandlet med enrofloxacin, idet de bedste resultater opnåedes med parenteral administration efterfulgt af oral administration.
English: Belgium EMDOKA bvba John Lijsenstraat 16
Danish: Belgien EMDOKA bvba John Lijsenstraat 16
English: Antibacterial spectrum
Danish: Antibakterielt spektrum
English: The results from the pharmacokinetic/pharmacodynamic (PK/PD) analysis with M. haemolytica were not fully predictive of clinical efficacy.
Danish: Resultaterne af den farmakokinetiske/farmakodynamiske (PK/PD) analyse med M. haemolytica var ikke fuldt ud prædiktive for den kliniske virkning.
English: For some serious animal indications, fluoroquinolones could be the only alternative available (EMEA/CVMP/SAGAM/184651/2005)7.
Danish: Til visse alvorlige indikationer hos dyr kan fluorquinoloner være det eneste tilgængelige alternativ (EMEA/CVMP/SAGAM/184651/2005)7.
English: The CVMP considered the target species and associated indications and dosages can be accepted because all species are considered as minor species, and no concern on safety or on efficacy has been reported in the Member States where these target species are authorised.
Danish: CVMP kunne godkende måldyrearterne og de tilknyttede indikationer og doseringer, da alle arterne betragtes som mindre betydningsfulde, og da der ikke er indberettet om problemer vedrørende sikkerhed eller virkning i de medlemsstater, hvor disse måldyrearter er godkendt.
English: Low to moderate (8% to 20%) resistance rates to ciprofloxacin have been observed in indicator isolates of E. coli for the different target species in different European countries.
Danish: Der er iagttaget lave til moderate (8 til 20 %) resistensrater over for ciprofloxacin hos indikatorisolater af E. coli for de forskellige måldyrearter i forskellige europæiske lande.
English: Therefore the CVMP recommended the removal of the target pathogen Histophilus somni from the product information.
Danish: CVMP anbefalede derfor at slette målpatogenet Histophilus somni fra produktinformationen.
English: and Actinobacillus pleuropneumoniae.
Danish: og Actinobacillus pleuropneumoniae.
English: aureus strains were isolated from commercial rabbit farms in different Member States and tested for resistance.
Danish: aureus fra kommercielle kaninbrug i forskellige medlemsstater isoleret og testet for resistens.
English: The results of different well controlled studies with natural enteric infection were reviewed.
Danish: Udvalget gennemgik resultaterne af forskellige velkontrollerede undersøgelser med naturlige enteroinfektioner.
English: 05-651 Drwalew Poland
Danish: 05-651 Drwalew Polen
English: Where the following target species have already been approved, the wording below relating to the relevant species should be used:
Danish: Når følgende måldyrearter allerede er godkendt, anvendes nedenstående ordlyd for de pågældende arter:
English: The critical PK parameters in milk were determined following intravenous administration of the 100 mg/ml strength and used to calculate the predictive PK/PD ratios together with MIC90 values for E. coli.
Danish: De kritiske PK-parametre i mælk blev bestemt efter forudgående intravenøs administration af styrken 100 mg/ml og anvendt til beregning af prædiktive PK/PD-forhold sammen med MIC90-værdier for E. coli.
English: It is expected that the use of these products for this indication may not be high, as the product is to be administered parenterally to rabbits with a frequency of daily injection for a period of 5 to 10 days.
Danish: Anvendelsen af disse produkter til denne indikation forventes ikke at blive omfattende, da produktet skal administreres parenteralt til kaniner dagligt i 5-10 dage.
English: Germany Albrecht GmbH Hauptstr.
Danish: Tyskland Albrecht GmbH Hauptstr.
English: Romikim Farma SL Gran Via Carlos III, 98,6 8027 Barcelona Spain
Danish: Romikim Farma SL Gran Via Carlos III, 98,6 8027 Barcelona Spanien
English: Warning sentences have been included in sections 4.5 and 4.6 of the SPC regarding the potential articular cartilage damage in growing cattle and lambs, based on the available literature.
Danish: Der er indsat advarselssætninger i produktresuméets punkt 4.5 og 4.6 om den potentielle skade på ledbrusken hos opvoksende kvæg og lam, baseret på den foreliggende litteratur.
English: Therefore the CVMP considered that these indications can be accepted for dogs and cats, when taking into account that the PK/PD data shown are theoretically predictive of good clinical efficacy in the treatment of the bacterial infections for which the products are intended, and the efficacy of the products has been confirmed by field studies and good clinical experience since more than two decades.
Danish: CVMP kunne derfor godtage disse indikationer for hunde og katte i betragtning af, at de forelagte PK/PD-data er teoretisk prædiktive for god klinisk virkning til behandling af de bakterielle infektioner, som produkterne er bestemt for, og produkternes virkning er bekræftet af feltundersøgelser og gode kliniske erfaringer gennem mere end to tiår.
English: The product can be administered by slow intravenous or subcutaneous administration.
Danish: Præparatet kan indgives ved langsom intravenøs eller subkutan administration.
English: 2065m 06516 Carros Cedex France
Danish: 2065m 06516 Carros Cedex Frankrig
English: All residues were below the MRL on the 4th milking (48 hours).
Danish: Alle restkoncentrationer var under maksimalgrænseværdien ved den 4. malkning (48 timer).
English: LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
Danish: Rumænien LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
English: The following information addressing the concern of the risk to public health (consumers and handlers) due to the potential for selection of antibiotic resistant strains of Staph.
Danish: Følgende oplysninger blev taget i betragtning i forbindelse med risikoen for den offentlige sundhed (forbrugere og personer i kontakt med dyrene) som følge af potentialet for selektion af antibiotikaresistente stammer af Staph.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, dyrearter, indgivelsesvej og ansøgere/indehavere af markedsføringstilladelse i medlemsstaterne
English: Regarding Pasteurella multocida, no particular conclusion could be drawn from the documentation provided, in view of the lack of precise microbiological data and considering that extrapolation of data from other formulations is not justified in this case.
Danish: For Pasteurella multocida kunne der ikke drages nogen særlig konklusion af den forelagte dokumentation på grund af de manglende præcise mikrobiologiske data og i betragtning af, at det i dette tilfælde ikke er berettiget at ekstrapolere fra data for andre formuleringer.
English: S.C. ROMVAC COMPANY S.A. Şos.
Danish: Rumænien S.C. ROMVAC COMPANY S.A. Şos.
English: The available data does fully demonstrate the efficacy of this veterinary medicinal product for the treatment of septicaemia.
Danish: De foreliggende data godtgør ikke fuldt ud virkningen af dette veterinærlægemiddel til behandling af septikæmi.
English: In complicated infections, higher dosages and longer treatment courses may be necessary.
Danish: Ved komplicerede infektioner kan højere dosering og længere behandlingsperiode være nødvendig.
English: Mare de Déu de Montserrat, 221
Danish: Montserrat, 221
English: Do not use in birds intended for human consumption.
Danish: Må ikke anvendes til fugle bestemt til menneskeføde.
English: Bayer SpA Viale Certosa, 130 20156 Milano Italy
Danish: Bayer SpA Viale Certosa, 130 20156 Milano Italien
English: Prahova Romania
Danish: Prahova Rumænien
English: no particular conclusion could be drawn from the documentation provided, in view of the lack of precise microbiological data (not allowing to assess the efficacy of the product against each of the isolated microorganisms specifically) or the lack of complete elimination of M. hyopneumoniae.
Danish: ikke drages en specifik konklusion af den forelagte dokumentation som følge af manglende præcise mikrobiologiske data (som ikke gav mulighed for at vurdere produktets specifikke virkning mod hver af de isolerede mikroorganismer) eller manglende fuldstændig elimination af M. hyopneumoniae.
English: In view of the lack of therapeutic alternatives, if this indication was not accepted, this product as well as many other antimicrobial products, could be used off-label (under the so-called cascade).
Danish: Da der ville mangle behandlingsalternativer, hvis denne indikation ikke var godkendt, kan både dette og andre antimikrobielle produkter tænkes at blive genstand for ikke-godkendt anvendelse (den såkaldte kaskadeeffekt).
English: In another study after five months at the end of the study, no enrofloxacin resistant bacteria could be isolated from the treated sows.
Danish: I en anden undersøgelse kunne der fem måneder efter undersøgelsens afslutning ikke isoleres enrofloxacin-resistente bakterier fra de behandlede søer.
English: This withdrawal period should be applied to all the concerned products.
Danish: Denne tilbageholdelsestid finder anvendelse på alle de berørte produkter.
English: All treated animals showed a rapid improvement in mammary gland functions, and no clinical differences were found between the two treatment schedules.
Danish: Alle behandlede dyr viste hurtig bedring i funktionen af mælkekirtlerne, og der blev ikke fundet forskelle mellem de to behandlingsplaner.
English: Different tolerance studies were conducted in calves with oral administration of enrofloxacin.
Danish: Der blev udført forskellige toleranceundersøgelser hos kalve med oral administration af enrofloxacin.
English: Furthermore, the veterinary practitioner will be left without an authorised product for the treatment of skin and wound infections caused by Staph.
Danish: Desuden vil den praktiserende dyrlæge stå uden et godkendt produkt til behandling af hudog sårinfektioner forårsaget af Staph.
English: The presence of bacteria including E. coli was determined.
Danish: Der blev bestemt tilstedeværelse af bakterier, herunder E. coli.
English: All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Danish: Alle mekanismer fører til, at bakterier får nedsat følsomhed over for fluoroquinoloner.
English: 21 Montee De La Garde 69340 Francheville France
Danish: Frankrig BIOLIS 21 Montee De La Garde 69340 Francheville Frankrig
English: Add, to all products: ADVICE ON CORRECT ADMINISTRATION
Danish: For alle produkter tilføjes: OPLYSNINGER OM KORREKT ANVENDELSE
English: In conclusion, this indication in sows can be accepted for the 100 mg/ml strength, but not for the 50 mg/ml strength, as the administration of the lower strength product is not practicable in heavy animals.
Danish: Som konklusion kan denne indikation til søer godtages for styrken 100 mg/ml, men ikke for 50 mg/ml, da den lavere styrke ikke er praktisk anvendelig til tunge dyr.
English: The Committee is aware that (i) the use of enrofloxacin in rabbit production could lead to an increase in Staph.
Danish: Udvalget er vidende om, at i) anvendelse af enrofloxacin i kaniner kan medføre øget resistens over for Staph.
English: B-2322 Hoogstraaten Belgium
Danish: B-2322 Hoogstraaten Belgien
English: In case of complicated infections higher doses may be necessary.
Danish: Ved komplicerede infektioner kan højere dosering være nødvendig.
English: The PK/PD analysis shows that the PK/PD ratios are largely exceeded for Gram-negative pathogens.
Danish: Analysen af PK/PD viser, at PK/PD-forholdene langt overgås for gramnegative patogener.
English: Germany Calluna Pharma bvba Treslong 34
Danish: Tyskland Calluna Pharma bvba Treslong 34
English: Cattle (intravenous)
Danish: Kvæg (intravenøst)
English: Regarding Histophilus somni, only susceptibility data originated in Canada, USA and Europe were provided, showing the high susceptibility of the bacterium to enrofloxacin.
Danish: For Histophilus somni blev der kun angivet følsomhedsdata fra Canada, USA og Europa, som viste høj følsomhed af bakterien over for enrofloxacin.
English: Germany Virbac S.A. 1ére Avenue L.I.D.
Danish: Tyskland Virbac S.A. 1ére Avenue L.I.D.
English: Enrofloxacin is also authorised for administration by oral route in farm rabbits all over Europe, and therefore CVMP considered that the use of an injectable solution could lead to a lesser exposure than the oral route as it can be individually administered to sick animals (with more precise dosage based on individual weights of animals) and can prevent the use in mass treatment.
Danish: Enrofloxacin er desuden godkendt til oral administration på kaninbrug i hele Europa, hvorfor CVMP fandt, at anvendelse af en injektionsvæske kunne føre til mindre eksponering end oral administration, da den kan administreres individuelt til syge dyr (med mere nøjagtig dosering baseret på dyrets vægt), så massebehandling kan undgås.
English: The results showed that all groups of medicated piglets increased in weight thus contrasting the control animals that were not treated with enrofloxacin.
Danish: Resultaterne viste, at alle grupper af medicinerede smågrise tog på i vægt i modsætning til kontroldyrene, der ikke blev behandlet med enrofloxacin.
English: 48308 Senden-Bösensell Germany
Danish: 48308 Senden-Bösensell Tyskland
English: No resistance was found in samples from sheep and goats.
Danish: Der blev ikke fundet resistens i prøver fra får eller geder.
English: Several publications and proprietary studies were reviewed.
Danish: Der blev gennemgået en række publikationer og ikke-publicerede undersøgelser.
English: In another study the efficacy against Staph.
Danish: En anden undersøgelse vedrørte virkningen mod Staph.
English: However, at the lower dose, residues were above the MRLs at day 1 but below the MRLs by the second time point (day 4 after administration).
Danish: Ved den lave dosis var restkoncentrationerne dog over maksimalgrænseværdierne på dag ét, men under maksimalgrænseværdierne på det næste tidspunkt (dag 4 efter administration).
English: The efficacy against M. haemolytica and Mycoplasma bovis has been justified with several experimental studies in which induced infection with M. haemolytica and M. bovis was produced.
Danish: Virkningen mod M. haemolytica og Mycoplasma bovis er godtgjort med flere eksperimentelle undersøgelser, hvor der blev fremkaldt infektion med M. haemolytica og M. bovis.
English: A 20% safety span was considered appropriate to compensate for the small number of animals used in the study.
Danish: Det fandtes passende med en sikkerhedsmargin på 20 % som kompensation for det lille antal dyr i undersøgelsen.
English: The withdrawal period should be applied to all the concerned products.
Danish: Tilbageholdelsestiden finder anvendelse på alle de berørte produkter.
English: The documentation provided was exactly the same, and both strengths (50 mg/ml and 100 mg/ml) have the same withdrawal periods.
Danish: Den forelagte dokumentation var nøjagtig den samme, og de to styrker (50 mg/ml og 100 mg/ml) har samme tilbageholdelsestid.
English: To compensate for deficiencies in the studies a safety span of 20% was considered appropriate, resulting in a withdrawal period of 96 hours (4 days).
Danish: For at kompensere for undersøgelsernes mangler ansås det for hensigtsmæssigt at tillægge en sikkerhedsmargin på 20 %, hvilket resulterede i en tilbageholdelsestid på 96 timer (4 dage).
English: - A study described the first case of livestock-associated methicillin-resistant Staph.
Danish: - En undersøgelse beskrev det første tilfælde af forekomst af meticillinresistente Staph.
English: - In another referral for an enrofloxacin oral solution (Hipralona Enro-S (EMEA/V/A/79))3 the Committee concluded that the risk is likely to be minor, in rabbits, in comparison with the other species due to the size of rabbit's production and no measures have been deemed necessary to minimize the risk for spread of methicillin resistant Staphylococcus aureus (MRSA) from those.
Danish: - I en anden indbringelsesprocedure vedrørende en oral opløsning af enrofloxacin (Hipralona Enro-S (EMEA/V/A/79))3 konkluderede udvalget, at risikoen må forventes at være ubetydelig hos kaniner i forhold til andre arter på grund af kaninproduktionens størrelse, og det er ikke fundet nødvendigt med foranstaltninger til minimering af risikoen for spredning af meticillinresistente Staphylococcus aureus (MRSA) derfra.
English: Data on the MIC of different isolates of M.haemolytica confirms the high susceptibility of this pathogen to enrofloxacin, as well as a very low resistance rate.
Danish: MIC-data for forskellige isolater af M.haemolytica bekræfter den høje følsomhed af denne patogen over for enrofloxacin samt en meget lav resistensandel.
English: The remaining indications i.e. mastitis, alimentary tract infections and septicaemia were extrapolated from sheep.
Danish: De øvrige indikationer, dvs. mastitis, mave-tarm-infektioner og septikæmi, blev ekstrapoleret fra får.
English: However, there are concerns regarding the moderate to high resistance rates observed in enteric E. coli isolated from cattle and pigs.
Danish: Der er imidlertid betænkelighed ved de moderate til høje resistensrater, der er konstateret hos enteriske E. coli isoleret fra kvæg og svin.
English: In pigs, the injection should be made in the neck at the ear base.
Danish: Injektionen bør gives i grisens nakke umiddelbart bag øret.
English: - In another study 56 Staph.
Danish: - I en anden undersøgelse blev 56 stammer af Staph.
English: Two enzymes essential in DNA replication and transcription, DNA gyrase and topoisomerase IV, have been identified as the molecular targets of fluoroquinolones.
Danish: To enzymer, der er essentielle for replikation og transkription af dna, dna-gyrase og topoisomerase IV, er identificerede som molekylære mål for fluoroquinloner.
English: Enrofloxacin showed better clinical results than oxytetracyclin at all dose levels, with a more rapid decrease of total clinical scores and faecal consistency scores.
Danish: Enrofloxacin medførte bedre kliniske resultater end oxytetracyclin på alle dosisniveauer, med hurtigere fald i total klinisk score og score for fæceskonsistens.
English: A systematic review and meta-analysis of more than 50 studies showed a high efficacy of enrofloxacin in treating porcine respiratory disease complex although the etiological agents were no detailed.
Danish: En systematisk gennemgang og metaanalyse af over 50 undersøgelser viste høj effektivitet af enrofloxacin til behandling af luftvejssygdomskompleks hos svin, men de ætiologiske agenser blev ikke angivet.
English: aureus isolates originating from rabbits is relatively rare compared to resistance in Staph.
Danish: aureus fra kaniner er forholdsvis sjælden i forhold til resistens af isolater af Staph.
English: Similarly, for Mycoplasma spp.
Danish: Tilsvarende kunne der for Mycoplasma spp.
English: Cattle (subcutaneous)
Danish: Kvæg (subkutant)
English: The results of the studies provided show that the variation in the residue profile due to sources of variation associated with the injectable use of these products (e.g. sampling procedure) was much higher than the variation due to formulation effect.
Danish: De forelagte undersøgelser viste, at der var kilder til variation i restkoncentrationsprofil (f.eks. prøvetagningsproceduren) efter injektion af de pågældende produkter, som medførte langt større variation end formuleringerne.
English: GENERA Slovenia d.o.o.
Danish: Slovenien GENERA Slovenien d.o.o.
English: Furthermore, it has to be considered that large differences exist in the pharmacokinetic behaviour of enrofloxacin among different species, which additionally will influence the decision about the correct dosage of “product name (to be completed nationally)”.
Danish: Endvidere bør det erindres, at der er en stor forskel i farmakokinetikken for enrofloxacin fra art til art, hvilket yderligere vil have indflydelse på fastsættelse af korrekt dosering af ”særnavn (færdiggøres nationalt”).
English: - A study, conducted in intensive rabbit farms in Spain, has demonstrated a high prevalence of Staph.
Danish: - En undersøgelse på kaninbrug i Spanien med intensivt opdræt har vist høj forekomst af stammer af Staph.
English: Moreover, the excessive volume of injection needed with the 50 mg/ml strength could lead to violation of allowed residues.
Danish: Det meget store injektionsvolumen, der er nødvendigt med styrken 50 mg/ml, vil desuden kunne medføre overskridelse af tærskelværdierne for restkoncentrationer.
English: The CVMP recommended the removal of the indication from the product information.
Danish: CVMP anbefalede derfor, at denne indikation slettes fra produktinformationen.