FrancophonIA/ELRC3.0 huggingface dataset:
English: Several proprietary studies and numerous scientific publications, documenting the efficacy of enrofloxacin, either by injectable and/or oral route of administration, were provided to demonstrate the efficacy against the above specified bacteria for the intended indications in both dogs and cats The data provided consist of studies performed with several posology regimens where the more frequent dose of 5 mg/kg bw was used.
Danish: Der blev forelagt adskillelige ikke-publicerede undersøgelser og en lang række videnskabelige publikationer, der dokumenterer virkningen af enrofloxacin ved injektion og/eller oral administration som dokumentation for virkningen mod ovennævnte bakterier ved de ansøgte indikationer hos både hunde og katte
English: C. For products listed in Annex I containing 100 mg enrofloxacin per ml
Danish: C. For de i bilag I opførte produkter, der indeholder 100 mg enrofloxacin pr. ml
English: Germany Krka d.d.
Danish: Tyskland Krka d.d.
English: Belgium SP Veterinaria SA Ctra.
Danish: Belgien SP Veterinaria SA Ctra.
English: Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg bw during 14 days.
Danish: Forandringer i ledbrusken blev observeret hos kalve behandlet oralt med 30 mg enrofloxacin/kg kropsvægt i 14 dage.
English: Dose determination and dose confirmation studies demonstrated the efficacy of the recommended dose.
Danish: Virkningen af den anbefalede dosis blev dokumenteret med undersøgelser til dosisfastlæggelse og dosisbekræftelse.
English: A. For products listed in Annex I containing 25 mg enrofloxacin per ml
Danish: A. For de i bilag I opførte produkter, der indeholder 25 mg enrofloxacin pr. ml
English: However, taking into account the available PK/PD and resistance data it has been concluded that the dose for this indication can be accepted only at 5 mg of enrofloxacin per kg bw once daily for 3 days by intramuscular injection.
Danish: Ud fra de foreliggende PK/PD-data og resistensdata kan der imidlertid til denne indikation godtages en dosis på 5 mg enrofloxacin/kg kropsvægt intramuskulært én gang dagligt i 3 dage.
English: (100 mg/ml strength)
Danish: (styrken 100 mg/ml)
English: Cats, dogs
Danish: Katte, hunde
English: Thus, the indication should be removed from the product information for the 50 mg/ml strength.
Danish: For styrken 50 mg/ml bør denne indikation derfor slettes fra produktinformationen.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Subcutaneous or intramuscular use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ Til subkutan og intramuskulær anvendelse.
English: At the recommended dose residues in all tissues were below the MRLs at day 1 postadministration.
Danish: På dag ét efter administration af den anbefalede dosis var restkoncentrationerne i alle væv under maksimalgrænseværdierne.
English: Lower isolation index of E. coli in treated animals was observed.
Danish: Hos de behandlede dyr var der lavere forekomst af isolation af E. coli.
English: Agnoletti et al. First reporting of methicillin-resistant Staphylococcus aureus (MRSA) ST398 in an industrial rabbit holding and in farm-related people.
Danish: Rev Sci Tech Off Int Epiz 2009;28:1119-1128 5 Agnoletti et al. First reporting of methicillin-resistant Staphylococcus aureus (MRSA) ST398 in an industrial rabbit holding and in farm-related people.
English: Treatment of post-partum dysgalactiae syndrome (PDS), mastitis, metritis, agalactia (MMA syndrome) caused by enrofloxacin susceptible strains of Escherichia coli, Klebsiella spp.
Danish: Behandling af post partum-dysgalactisyndrom (PDS), mastitis, metritis, agalacti (MMA-syndrom) forårsaget af enrofloxacin-følsomme stammer af Escherichia coli og Klebsiella spp.
English: The first time point at which all residue values fell below the MRL was 9 days.
Danish: Det første tidspunkt, hvor alle restkoncentrationer var under maksimalgrænseværdien, var 9 dage.
English: It was considered appropriate to derive a single harmonised withdrawal period based on the combined data from the four studies.
Danish: Det blev anset for hensigtsmæssigt at udlede en enkelt harmoniseret tilbageholdelsestid baseret på de kombinerede data fra alle fire undersøgelser.
English: Rabbits: Meat and offal: 6 days.
Danish: Kaniner: Slagtning: 6 døgn
English: 4.2 Indications for use, specifying the target species Calves
Danish: 4.2 Terapeutiske indikationer, med angivelse af de dyrearter, som lægemidlet er beregnet til
English: Cattle (100 mg/ml strength)
Danish: Kvæg (styrken 100 mg/ml)
English: The study results indicate that the pharmacokinetics of enrofloxacin did not differ significantly between sheep and goats.
Danish: Resultaterne viser, at der ikke var væsentlige forskelle mellem får og geder i farmakokinetikken af enrofloxacin.
English: Two different enrofloxacin treatment schemes were investigated: 5 mg/kg bw for 3 days and 2.5 mg/kg for 5 days.
Danish: Undersøgelsen omfattede to forskellige behandlingsplaner med enrofloxacin: 5 mg/kg/kropsvægt i 3 dage og 2,5 mg/kg i 5 dage.
English: In this case, the withdrawal period following subcutaneous injection applies.
Danish: Den anden dosis kan gives via subkutan rute, hvorefter tilbageholdelsestiden efter subkutan injektion gælder.
English: Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible, supported by susceptibility testing of the causal organism, indicates enrofloxacin as the substance of choice.
Danish: Behandling af infektioner i fordøjelseskanalen og luftveje i tilfælde, hvor klinisk erfaring, hvis muligt understøttet af resistensbestemmelse på den kausale organisme, indikerer, at enrofloxacin er førstevalg.
English: B. For products listed in Annex I containing 50 mg enrofloxacin per ml
Danish: B. For de i bilag I opførte produkter, der indeholder 50 mg enrofloxacin pr. ml
English: Dogs, cats
Danish: Hunde, katte
English: Germany Vetpharma Animal Health, S.L.
Danish: Tyskland Vetpharma Animal Health, S.L.
English: Rabbits (25 mg/ml strength)
Danish: Kaniner (styrken 25 mg/ml)
English: Cage birds, cats, dogs, exotic animals, reptiles, small mammals
Danish: Burfugle, katte, hunde, eksotiske dyr, krybdyr, små pattedyr
English: CENAVISA SA LABORATORIOS Cami Pedra Estela s/n 43205 REUS
Danish: Rumænien CENAVISA SA LABORATORIOS Cami Pedra Estela s/n
English: Belgium Vetpharma Animal Health, S.L.
Danish: Belgien Vetpharma Animal Health, S.L.
English: Milk (50 mg/ml and 100 mg/ml strengths): One residue depletion studies was provided with animals treated at 5 mg/kg bw for 5 days.
Danish: Mælk (styrkerne 50 mg/ml og 100 mg/ml): Der blev forelagt én restkoncentrationsundersøgelse med dyr, der var behandlet med 5 mg/kg kropsvægt i 5 dage.
English: Consequently, based on the recommended withdrawal period of 4 days for sheep meat and offal and applying a safety span of 1.5, a withdrawal period of 6 days can be recommended for goat meat and offal when animals are treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strenghts by subcutaneous injection.
Danish: På grundlag af den anbefalede tilbageholdelsestid på 4 dage for kød og indmad fra får og med en sikkerhedsfaktor på 1,5 kan der anbefales en tilbageholdelsestid på 6 dage for kød og indmad fra geder, der er behandlet med den anbefalede dosis på 5 mg/kg kropsvægt subkutant med styrken 50 mg/ml eller 100 mg/ml.
English: Pigs, rabbits, dogs, cats, exotic animals (mammals, birds, reptiles)
Danish: Svin, kaniner, hunde, katte, eksotiske dyr (små pattedyr, fugle og krybdyr)
English: Calves (50 mg/ml strength)
Danish: Kalve (styrken 50 mg/ml)
English: The documentation provided was considered acceptable to support the efficacy of enrofloxacin against infections of the alimentary and respiratory tracts caused by Escherichia coli, Pasteurella multocida and Staphylococcus spp.
Danish: Den forelagte dokumentation blev godtaget for virkningen af enrofloxacin mod mave-tarm- og luftvejsinfektioner forårsaget af Escherichia coli, Pasteurella multocida and Staphylococcus spp.
English: Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by enrofloxacin susceptible strains of Escherichia coli and Klebsiella spp.
Danish: Behandling af post partum dysgalakti syndrom, PDS (MMA syndrom) forårsaget af enrofloxacinfølsomme stammer af Escherichia coli og Klebsiella spp.
English: A harmonised withdrawal period of 5 days can be accepted for cattle meat and offal when animals are treated at the recommended dose of 5 mg/kg bw with either the 50 mg/ml strength or the 100 mg/ml strengths administered intravenously.
Danish: En harmoniseret tilbageholdelsestid på 5 dage kan godtages for kød og indmad fra kvæg, når dyrene behandles med den anbefalede dosis på 5 mg/kg kropsvægt intravenøst enten med styrken 50 mg/ml eller 100 mg/ml.
English: Clinical outcome was demonstrated on sows with MMA/PDS treated with enrofloxacin.
Danish: Der blev påvist klinisk virkning af enrofloxacin til behandling af søer med MMA/PDS.
English: Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp.
Danish: I den anbefalede terapeutiske dosis er enrofloxacin aktivt over for mange gram-negative bakterier; som Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp.
English: The first time point at which all residue values fell below the MRL was 10 days.
Danish: Det første tidspunkt, hvor alle restkoncentrationer var under maksimalgrænseværdien, var 10 dage.
English: Thus a withdrawal period of 72 hours (3 days) is recommended for milk from cattle treated at the recommended dose of 5 mg/kg bw/day with the 100 mg/ml strength intravenously.
Danish: Der anbefales således en tilbageholdelsestid på 72 timer (3 dage) for mælk fra kvæg behandlet med den anbefalede dosis på 5 mg/kg kropsvægt/dag intravenøst med styrken 100 mg/ml.
English: Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp.
Danish: I den anbefalede terapeutiske dosis er enrofloxacin aktivt over for mange gram-negative bakterier; som Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp.
English: Taking into account all data, the CVMP considered that both indications can be accepted.
Danish: I betragtning af ovenstående kunne CVMP godtage begge disse indikationer.
English: Consequently, the recommended withdrawal period of 4 days for cattle milk can be directly extrapolated to goat's milk when animals are treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strengths by subcutaneous injection.
Danish: Den anbefalede tilbageholdelsestid på 4 dage for mælk fra kvæg kan derfor direkte ekstrapoleres til gedemælk, når dyrene er behandlet med den anbefalede dosis på 5 mg/kg kropsvægt/dag subkutant i 5 dage med styrken 50 mg/ml eller 100 mg/ml.
English: Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis.
Danish: Behandling af akut mycoplasma-arthritis forårsaget af enrofloxacinfølsomme stammer af Mycoplasma bovis.
English: Belgium FORTE Healthcare Limited Cougar Lane
Danish: Belgien FORTE Healthcare Limited Cougar Lane
English: Sheep and Goats (50 mg/ml and 100 mg/ml strengths) Both strengths share the same indications, but differences exist in terms of target animal species i.e. in the 50 mg/ml strength the species were stated as dairy ewes/lambs and dairy goats/kids whereas in the 100 mg/ml strength the species were sheep and goats.
Danish: Der gælder samme indikationer for begge styrker, men ikke samme måldyrearter: For 50 mg/ml var måldyrearterne angivet som malkefår/lam og malkegeder/kid, mens måldyrearten for 100 mg/ml var får og geder.
English: Bayer d.o.o.
Danish: Slovenien Bayer d.o.o.
English: Milk: 4 days.
Danish: Slagtning: 4 døgn Mælk: 3 døgn
English: Meat and offal (50 mg/ml and 100 mg/ml strengths): Two residue depletion studies were provided with sheep treated at 5 mg/kg bw for 5 days.
Danish: Kød og indmad (styrkerne 50 mg/ml og 100 mg/ml): Der blev forelagt to restkoncentrationsundersøgelser med får, der var behandlet med 5 mg/kg kropsvægt i 5 dage.
English: Germany SP Veterinaria SA Ctra.
Danish: Tyskland SP Veterinaria SA Ctra.
English: Not more than 10 ml should be administered at one subcutaneous injection site.
Danish: Der må ikke gives mere end 10 ml på hvert subkutane injektionssted.
English: It has been noted that the indications, posology and withdrawal periods approved by the Member States for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products authorised under Article 13 of Directive 2001/82/EC are disharmonised across the Member States (EU/EEA).
Danish: Det er konstateret afvigelser mellem de i EU-/EØS-medlemsstaterne godkendte indikationer, doseringer og tilbageholdelsestider for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable og relaterede navne samt beslægtede lægemidler, der er godkendt i henhold til artikel 13 i direktiv 2001/82/EF.
English: Following subcutaneous injection: Meat and offal: 12 days.
Danish: Efter subkutan injektion: 12 døgn
English: Dogs, pigs, calves
Danish: Hunde, svin, kalve
English: Not more than 3 ml should be administered at one intramuscular injection site.
Danish: Der må ikke gives mere end 3 ml på hvert intramuskulære injektionssted.
English: The Cmax/MIC and AUC/MIC ratios for Staphylococcus spp.
Danish: er forholdene Cmax/MIC og AUC/MIC passende mod infektion med grampositive organismer hos begge dyrearter.
English: Lithuania FORTE Healthcare Limited Cougar Lane
Danish: Litauen FORTE Healthcare Limited Cougar Lane
English: Dogs, cats, exotic animals (small mammals, reptiles and birds)
Danish: Hunde, katte, eksotiske dyr (små pattedyr, krybdyr og fugle)
English: aureus in commercial dairy herds was investigated.
Danish: aureus i besætninger af malkefår.
English: Belgium Industrial Veterinaria SA C/Esmeralda 19-21
Danish: Belgien Industrial Veterinaria SA C/Esmeralda 19-21
English: Not more than 6 ml should be administered at one subcutaneous injection site.
Danish: Der må ikke gives mere end 6 ml på hvert subkutane injektionssted.
English: Following intravenous injection: Meat and offal: 5 days.
Danish: Efter intravenøs injektion: 5 døgn
English: Calves, pigs
Danish: Kalve, svin
English: Germany Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
Danish: Tyskland Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
English: Dogs, cattle, poultry, cats, pigs
Danish: Hunde, kvæg, fjerkræ, katte, svin
English: • on the basis of the available residue depletion data in cattle, pigs, sheep, goats and rabbits chickens and turkeys, the CVMP considered that withdrawal periods should be aligned to provide assurance for consumer safety;
Danish: • CVMP fandt, at tilbageholdelsestiderne af hensyn til forbrugersikkerheden bør bringes i overensstemmelse ud fra de foreliggende restkoncentrationsdata hos kvæg, svin, får og geder samt kaniner, kyllinger og kalkuner
English: Belgium Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
Danish: Belgien Laboratorios Calier, S.A. c/ Barcelonès, 26 (Pla del Ramassà)
English: Germany Industrial Veterinaria SA C/Esmeralda 19-21
Danish: Tyskland Industrial Veterinaria SA C/Esmeralda 19-21
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma spp.
Danish: Behandling af luftvejsinfektioner forårsaget af enrofloxacin-følsomme stammer af Actinobacillus pleuropneumoniae, Pasteurella multocida og Mycoplasma spp.
English: - Dosage: 5 mg/kg body weight (bw), once daily for 3 to 5 days.
Danish: - Dosering: 5 mg/kg kropsvægt én gang dagligt i 3-5 dage.
English: Bravničarjeva 13 Ljubljana Slovenia
Danish: Bravničarjeva 13
English: aureus isolated from goat mastitis was also very low.
Danish: aureus fra mastitis hos geder.
English: This is recommended as the withdrawal period for milk from cattle treated at the recommended dose of 5 mg/kg bw with the 100 mg/ml strength subcutaneously.
Danish: Dette er den anbefalede tilbageholdelsestid for mælk fra kvæg behandlet med den anbefalede dosis på 5 mg/kg kropsvægt subkutant med styrken 100 mg/ml.
English: Dogs, cats, pigs, rabbits
Danish: Hunde, katte, svin, kaniner
English: Pigs, rabbits, dogs, cats
Danish: Svin, kaniner, hunde, katte
English: Enrofloxacin 25 mg/ml and 50 mg/ml
Danish: Enrofloxacin 25 mg/ml and
English: Treatment of infections of the alimentary and respiratory tracts caused by enrofloxacin susceptible strains of: Escherichia coli, Pasteurella multocida and Staphylococcus spp.
Danish: Behandling af infektioner i fordøjelseskanalen og luftveje forårsaget af enrofloxacinfølsomme stammer af: Escherichia coli, Pasteurella multocida og Staphylococcus spp.
English: This is recommended as the withdrawal period for pig meat and offal for animals treated at the recommended dose of 5 mg/kg bw/day for 3 days with either the 25 mg/ml, 50 mg/ml or 100 mg/ml strenghts administered by intramuscular injection.
Danish: Dette er den anbefalede tilbageholdelsestid for kød og indmad fra svin, der er behandlet med den anbefalede dosis på 5 mg/kg kropsvægt/dag intramuskulært i 3 dage enten med styrken 25 mg/ml, 50 mg/ml eller 100 mg/ml.
English: The MAH proposed a withdrawal period of
Danish: Indehaveren af markedsføringstilladelse foreslog en tilbageholdelsestid på 5 dage.
English: - Dosage for reptiles: 5-10 mg/kg bw, once daily by intramuscular injection for 5 consecutive days.
Danish: - Dosering til krybdyr: 5-10 mg/kg kropsvægt intramuskulært én gang dagligt i 5 på hinanden følgende dage.
English: Treatment of acute severe mastitis caused by enrofloxacin susceptible strains of Escherichia coli.
Danish: Behandling af alvorlig akut mastitis forårsaget af enrofloxacinfølsomme stammer af Escherichia coli.
English: Meat and offal: 5 days.
Danish: Slagtning: 5 døgn
English: Pigs (50 mg/ml and 100 mg/ml strengths)
Danish: Svin (styrkerne 50 mg/ml og 100 mg/ml)
English: Acute severe mastitis caused by Staphylococcus aureus (100 mg/ml strength) Taking into account the available data, the CVMP concluded that the poor bacteriological results obtained in vivo and the results from the PK/PD analysis do not sufficiently support this indication.
Danish: CVMP konkluderede, at der ikke var tilstrækkeligt grundlag for denne indikation efter gennemgang af de foreliggende data, herunder de dårlige bakteriologiske resultater in vivo og resultaterne af den farmakokinetiske/farmakodynamiske analyse.
English: Treatment of mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus, Escherichia coli.
Danish: Behandling af mastitis forårsaget af enrofloxacin-følsomme stammer af Staphylococcus aureus og Escherichia coli.
English: - Dosage for ornamental birds: 20 mg/kg bw, once daily by intramuscular injection for 5-10
Danish: - Dosering til prydfugle: 20 mg/kg kropsvægt intramuskulært én gang dagligt i 5-10 på hinanden følgende dage.
English: Treatment of Escherichia coli infections of the alimentary tract or septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
Danish: Behandling af mave-tarm-infektioner med Escherichia coli eller septikæmi forårsaget af enrofloxacinfølsomme stammer af Escherichia coli.
English: Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions.
Danish: For at undgå bivirkninger, skal særlig opmærksomhed udvises ved samtidig brug af flunixin og enrofloxacin til hunde.
English: - Dosage: 5 mg/kg bw, once daily by subcutaneous injection for up to 5 days.
Danish: - Dosering: 5 mg/kg kropsvægt subkutant én gang dagligt i op til 5 dage.
English: Belgium Chanelle Pharmaceuticals Manufacturing Ltd.
Danish: Belgien Chanelle Pharmaceuticals Manufacturing Ltd.
English: On the basis of the available data the CVMP considered that these indications can be accepted.
Danish: CVMP kunne godtage disse indikationer på grundlag af de foreliggende data.
English: Cattle, pigs, sheep
Danish: Kvæg, svin, får
English: Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old.
Danish: Behandling af akut mycoplasma-arthritis hos kvæg yngre end 2 år, forårsaget af enrofloxacinfølsomme stammer af Mycoplasma bovis.
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida and Mannheimia haemolytica.
Danish: Behandling af luftvejsinfektioner forårsaget af enrofloxacinfølsomme stammer af Pasteurella multocida og Mannheimia haemolytica.
English: A withdrawal period of 72 hours (3 days) is recommended for sheep milk for animals treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strengths by subcutaneous injection.
Danish: Der anbefales således en tilbageholdelsestid på 72 timer (3 dage) dage for mælk fra får, der er behandlet med den anbefalede dosis på 5 mg/kg kropsvægt/dag subkutant i 5 dage med styrken 50 mg/ml eller 100 mg/ml.
English: 20 mg/kg bw, corresponding to 0.8 ml/kg bw, once daily by intramuscular injection for 5 to 10 consecutive days.
Danish: 0,8 ml/kg kropsvægt en gang dagligt ved intramuskulær injektion 5-10 dage i træk.
English: 4.9 Amounts to be administered and administration route Intravenous, subcutaneous or intramuscular use.
Danish: Til intravenøs, subkutan og intramuskulær anvendelse.
English: Taking into account all data, the CVMP considered that this indication can be accepted.
Danish: CVMP kunne godtage denne indikation efter at have taget samtlige data i betragtning.
English: Cattle (calves), pigs, dog
Danish: Kvæg (kalve), svin, hunde
English: Germany Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Danish: Tyskland Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
English: Cats, dogs, sheep, cattle, pigs, goats
Danish: Katte, hunde, får, kvæg, svin, geder
English: Treatment of mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus and Escherichia coli.
Danish: Behandling af mastitis forårsaget af enrofloxacinfølsomme stammer af Staphylococcus aureus og Escherichia coli.
English: Sheep (50 mg/ml and 100 mg/ml strengths)
Danish: Får (styrkerne 50 mg/ml og 100 mg/ml)
English: Thus, a withdrawal period of 4 days is recommended for sheep meat and offal for animals treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strengths by subcutaneous injection.
Danish: Der anbefales således en tilbageholdelsestid på 4 dage for kød og indmad fra kvæg, der er behandlet med den anbefalede dosis på 5 mg/kg kropsvægt/dag subkutant i 5 dage med styrken 50 mg/ml eller 100 mg/ml.
English: Denmark Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Danish: Danmark Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
English: Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 5 days.
Danish: Akut mycoplasma-ledbetændelse hos kvæg yngre end 2 år forårsaget af enrofloxacin-følsomme stammer af Mycoplasma bovis: 5 mg enrofloxacin/kg kropsvægt, svt.
English: Taking into account all data available (clinical, PK/PD and antimicrobial resistance data), the CVMP considered that this indication can be accepted.
Danish: CVMP kunne godtage denne indikation efter at have taget samtlige data i betragtning (kliniske, farmakokinetiske/farmakodynamiske og antimikrobielle resistensdata).
English: Target species, indications and posology
Danish: Dyrearter, som lægemidlet er beregnet til, indikationer og dosering
English: - Dosage: 10 mg/kg bw, once daily for 5 to 10 consecutive days by subcutaneous administration.
Danish: - Dosering: 10 mg/kg kropsvægt subkutant én gang dagligt i 5-10 på hinanden følgende dage.
English: SC: Meat and offal: 12 days.
Danish: S.c.: 12 døgn
English: Germany Chanelle Pharmaceuticals Manufacturing Ltd.
Danish: Tyskland Chanelle Pharmaceuticals Manufacturing Ltd.