FrancophonIA/ELRC3.0 huggingface dataset:
English: Manufacturer responsible for batch release: To be completed nationally
Danish: Fremstiller ansvarlig for batchfrigivelse: Færdiggøres nationalt
English: Tmax (h) Cmax (µg/ml)
Danish: Tmax (t) Cmax (µg/ml)
English: In countries where feeding of fallen stock to scavenger bird populations is permitted as a conservation measure (see Commission Decision 2003/322/EC), the possible risk to hatching success should be considered before feeding carcasses of livestock recently treated with this product.
Danish: I lande hvor fodring af populationen af ådselsædende fugle med døde dyr er tilladt af bevaringshensyn (se Kommissionens beslutning 2003/322/EF), skal den mulige risiko for ynglesucces overvejes før kadavere af produktionsdyr nyligt behandlet med dette præparat udfodres.
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/PDdata.
English: Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation.
Danish: Bør ikke anvendes til dyr med epilepsi eller som lider af kramper, idet enrofloxacin kan forårsage CNS-stimulation.
English: The overall evaluation of the submitted data (clinical, PK/PD and resistance data) show that the dose of 2.5 mg/kg bw/day may not allow for a complete elimination of bacteria and it could lead to an increased resistance development.
Danish: Den overordnede vurdering af de forelagte data (kliniske, farmakokinetiske/farmakodynamiske data samt resistensdata) viser, at dosen 2,5 mg/kg kropsvægt/dag muligvis ikke tillader fuldstændig elimination af bakterierne og kan medføre øget resistensudvikling.
English: Official and local antimicrobial policies should be taken into account when the product is used.
Danish: Officielle og lokale retningslinjer for brug af antibiotika bør overvejes ved brug af præparatet.
English: The latter also applies for alimentary tract infections and septicaemia caused by E. coli in pigs.
Danish: Sidstnævnte gælder også mave-tarm-infektioner og septikæmi forårsaget af E. coli hos svin.
English: African Grey Parrots serum ciprofloxacin concentrations were 3-78% of the enrofloxacin dose, with an increasing ciprofloxacin/enrofloxacin ratio with multiple doses.
Danish: I den afrikanske grå papegøje udgør serumkoncentrationen af ciprofloxacin 3-78% af enrofloxacin dosen, med et stigende ciprofloxacin/enrofloxacin forhold ved gentagen dosering.
English: Bioavailability is high (approximately 100% in pig and cattle) with a low to moderate plasma protein binding (approximately 20 to 50%).
Danish: Biotilgængeligheden er høj (ca.100% hos svin og kvæg) med en lav til moderat plasmaproteinbinding (ca. 20 til 50%).
English: The data provided are insufficient to justify two indications in cattle (i) ‘treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Histophilus somni' and (ii) ‘treatment of acute severe mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus'.
Danish: De forelagte data udgør ikke tilstrækkeligt grundlag for to indikationer hos kvæg, nemlig i) “behandling af luftvejsinfektioner forårsaget af enrofloxacin-følsomme stammer af Histophilus somni” og ii) “behandling af akut svær mastitis forårsaget af enrofloxacin-følsomme stammer af Staphylococcus aureus”.
English: Do not use concurrently with theophylline as the elimination of theophylline may be delayed.
Danish: Må ikke bruges samtidig med theophyllin, da udskillelsen af theophyllin kan blive forlænget.
English: Bioavailability is high (approximately 100% in pigs) with a low to moderate plasma protein binding (approximately from 20 to 50%).
Danish: Biotilgængeligheden er høj (ca.100% hos svin) med en lav til moderat plasmaproteinbinding (ca. 20 til 50%).
English: This section takes into account a possible hypersensitivity to fluoroquinolones or to any excipients of the product.
Danish: I dette afsnit tages der hensyn til mulig overfølsomhed for fluorquinoloner eller ethvert af produktets hjælpestoffer.
English: Pregnancy and lactation and lay:
Danish: Drægtighed, laktation og æglægning:
English: On 26 October 2012, France sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names.
Danish: Den 26. oktober 2012 foretog Frankrig i medfør af artikel 34, stk. 1, i direktiv 2001/83/EF, som ændret, en indbringelse for CVMP/Det Europæiske Lægemiddelagentur vedrørende Baytril 2,5 % til injektion, Baytril 5 % til injektion og Baytril 10 % til injektion og deres relaterede navne.
English: Accumulation in plasma does not occur following a treatment interval of 24 h.
Danish: Der sker ikke akkumulering i plasma med behandlingsinterval på 24 t.
English: Animal Health Division Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA
Danish: Strawberry Hill Newbury, Berkshire RG14 1JA
English: aureus following use of the product in food rabbits was considered:
Danish: aureus efter brug af produktet hos fødevareproducerende kaniner.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES One ml solution contains:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER 1 ml opløsning indeholder:
English: As enrofloxacin is known to cause CNS stimulation, the contraindications in epileptic animals or in animals that suffer from seizures are justified.
Danish: Da enrofloxacin vides at være CNS-stimulerende, findes det berettiget, at det er kontraindiceret hos epileptiske dyr eller dyr, der lider af krampeanfald.
English: These signs are generally mild and transient.
Danish: Disse tegn er sædvanligvis lette og forbigående.
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
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: Terminal half-life (h) Elimination half-life (h) F (%)
Danish: Terminal halveringstid (t) Eliminationshalveringstid (t) F (%)
English: • the CVMP considered the scope of the referral was the harmonisation of the summaries of product characteristics, labelling and package leaflets;
Danish: • CVMP behandlede indbringelsen med henblik på formålet om at harmonisere produktresuméerne, etiketteringen og indlægssedlerne
English: Overall summary of the scientific evaluation of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Baytril 2,5 % til injektion, Baytril 5 % til injektion og Baytril 10 % til injektion og deres relaterede navne (se bilag I)
English: Primary degenerative lesions were noted in stifle joints of all calves that were treated with 90 mg/kg bw and in one calf that was treated with 30 mg/kg bw.
Danish: Der blev fundet primære degenerative forandringer i knæleddene på alle kalve, der blev behandlet med 90 mg/kg kropsvægt, og på én kalv behandlet med 30 mg/kg kropsvægt.
English: The product can be used in pregnant cows during the 1st quarter of pregnancy.
Danish: Kan anvendes til drægtige køer under den første ¼-del af drægtigheden.
English: Intravenous, subcutaneous or intramuscular use.
Danish: Til intravenøs, subkutan og intramuskulær anvendelse.
English: Special caution should be taken when using enrofloxacin in animals with impaired renal function.
Danish: Særlig forsigtighed skal iagttages ved brug af enrofloxacin til dyr med nedsat nyrefunktion.
English: ADVICE ON CORRECT ADMINISTRATION To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE For at sikre korrekt dosering og undgå underdosering bør kropsvægten fastslås så nøjagtigt som muligt.
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/PDdata og resistensdata ved vurderingen af enrofloxacins virkning mod Mycoplasma spp.
English: In calves, transient local tissue reactions may occur in very rare cases and may be observed up to 14 days.
Danish: I meget sjældne tilfælde kan der hos kalve forekomme en forbigående lokal vævsreaktion, som kan vare i op til 14 dage.
English: Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names are solutions for injection containing enrofloxacin at 25 mg/ml, 50 mg/ml and 100 mg/ml respectively.
Danish: Baytril 2,5 % til injektion, Baytril 5 % til injektion og Baytril 10 % til injektion og deres relaterede navne er injektionsvæsker, opløsning, der indeholder enrofloxacin i en koncentration på hhv. 25 mg/ml, 50 mg/ml og 100 mg/ml.
English: Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols).
Danish: Enrofloxacin må ikke bruges samtidig med antimikrobielle stoffer, som har antagonistisk virkning over for quinoloner (f.eks. makrolider, tetracykliner eller fenikoler).
English: {Name and address} <{Tel.}> <{Fax}> <{E-mail}>
Danish: }> <{Fax}> <{E-mail}>
English: France referred the issue due to divergent national decisions having been taken by the Member States (EU/EEA) resulting in discrepancies in the product information for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names.
Danish: Frankrig indbragte sagen, fordi der som følge af divergerende nationale afgørelser i EU-/EØSmedlemsstaterne var uoverensstemmelser i produktinformationen for Baytril 2,5 % til injektion, Baytril 5 % til injektion og Baytril 10 % til injektion og deres relaterede navne.
English: Marketing authorisation holder: To be completed nationally
Danish: Indehaver af markedsføringstilladelsen: Færdiggøres nationalt
English: 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: The data provided consist of studies performed with several posology regimens where the more frequent dose of 5 mg/kg bw was used.
Danish: De forelagte data er undersøgelser med forskellige doseringsregimer, hvoraf den hyppigste var 5 mg/kg kropsvægt.
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
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: Enrofloxacin and ciprofloxacin distribute well into all target tissues, e.g. lung, kidney, skin and liver, reaching 2- to 3-fold higher concentrations than in plasma.
Danish: Enrofloxacin og ciprofloxacin distribueres godt til alle målorganer, f.eks. lunge, nyrer, hud og lever, hvor koncentrationen bliver 2 til 3 gange højere end i plasma.
English: 50 ml and 100 ml in a cardboard box.
Danish: 50 ml og 100 ml i papkarton.
English: The use of enrofloxacin in growing lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, not associated to clinical signs.
Danish: Anvendelse af enrofloxacin hos lam i opvækst ved den anbefalede dosis i 15 dage medførte histologiske forandringer i ledbrusken uden ledsagende kliniske tegn.
English: Bayer BV Energieweg 1
Danish: Energieweg 1
English: The specific properties of enrofloxacin regarding both its use in animals with renal disorders and retinal toxicity in cats are also stated.
Danish: Endvidere angives der særlige egenskaber af enrofloxacin, dels ved anvendelse hos dyr med nyrelidelser, dels retinal toksicitet hos katte.
English: In dogs, cattle, sheep and goats, overdose has not been documented.
Danish: Hos hunde, kvæg, får og geder er der ikke beskrevet overdosering.
English: Target inhibition is caused by noncovalent binding of fluoroquinolone molecules to these enzymes.
Danish: Inhiberingen af disse enzymer sker ved ikke-kovantent binding til fluoroquinolon molekyler.
English: Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects but have shown evidence of foetotoxic effects at maternotoxic doses.
Danish: Laboratorieundersøgelser af rotter og kaniner har ikke afsløret teratogene virkninger, men har vist føtal toksicitet ved doser, der gav maternel toksicitet.
English: 6.1 List of excipients n-Butyl alcohol
Danish: 6.1 Fortegnelse over hjælpestoffer n-butylalkohol
English: Whenever possible fluoroquinolones should only be used based on susceptibility testing.
Danish: Anvendelse af fluoroquinoloner bør så vidt muligt baseres på resistensbestemmelse.
English: Pack-sizes:
Danish: Pakningsstørrelser:
English: Wash any splashes from skin or eyes immediately with water.
Danish: I tilfælde af spild på hud og i øjne skylles straks med vand.
English: The warning regarding possible degenerative changes of articular cartilage in calves is supported by a study in which calves (2 weeks old) were orally administered with 0, 30 or 90 mg/kg bw of enrofloxacin per day for 14 days.
Danish: Advarsler om mulige degenerative forandringer i ledbrusken hos kalve er baseret på en undersøgelse, hvor kalve (i alderen 2 uger) fik oralt enrofloxacin i en dosis af 0, 30 eller 90 mg/kg kropsvægt dagligt i 14 dage.
English: For cats weighting less than 5 kg, the dosage of 25 mg/ml is more appropriate to avoid risk of overdosage (see section 4.10).
Danish: For at reducere risikoen for overdosering af katte, der vejer mindre end 5 kg, er brug af styrken på 25 mg/ml mere hensigtsmæssigen (se afsnit 4.10).
English: People with known hypersensitivity to fluoroquinolones should avoid any contact with the product.
Danish: Ved overfølsomhed over for fluoroquinoloner, bør kontakt med lægemidlet undgås.
English: Care should be taken to avoid accidental self-injection.
Danish: Selvinjektion ved hændeligt uheld bør undgås.
English: Documentation that describes the uses of the injectable veterinary medicinal product in the treatment of infections of both the alimentary and respiratory tract, as well as for the treatment of skin and wound infections was provided.
Danish: Der blev fremlagt dokumentation, der beskriver anvendelserne af det veterinære injektionspræparat til behandling af infektioner i både mave-tarm-kanalen og luftvejene samt hudog sårinfektioner.
English: Acute severe mastitis caused by Staphylococcus aureus (100 mg/ml strength)
Danish: Akut svær mastitis forårsaget af Staphylococcus aureus (styrken 100 mg/ml)
English: To ensure a correct dosage, body weight (bw) 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papkarton
English: Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg body weight during 14 days.
Danish: Degenerative forandringer i ledbrusken blev observeret hos kalve behandlet oralt med 30 mg enrofloxacin/kg kropsvægt i 14 dage.
English: Subcutaneous or intramuscular use.
Danish: Til subkutan og intramuskulær anvendelse.
English: For cats weighting less than 5 kg, the dosage of 25 mg/ml is more appropriate to avoid risk of overdosage (see Overdose).
Danish: For at reducere risikoen for overdosering af katte, der vejer mindre end 5 kg, er brug af styrken på 25 mg/ml mere hensigtsmæssigen (se Overdosering).
English: Use of the product including use deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to enrofloxacin and may decrease the effectiveness of treatment with all fluoroquinolones due to the potential for cross-resistance.
Danish: Hvis anvendelsen af dette lægemiddel til dyr afviger fra de instruktioner, der er angivet i produktresumeet, kan prævalensen af bakterie-resistens overfor fluoroquinoloner øges, med risiko for nedsat virkning af andre quinoloner som følge af mulig krydsresistens.
English: Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany
Danish: Tyskland Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Tyskland
English: Clear light-yellow solution.
Danish: Klar let gul opløsning.
English: Use in pregnancy and lactation
Danish: Anvendelse under drægtighed og diegivning
English: Cats have been shown to suffer ocular damage after receiving doses of more than 15 mg/kg once daily for 21 consecutive days.
Danish: Katte er påvist at få øjenbeskadigelse efter doser på over 15 mg/kg kropsvægt én gang dagligt i 21 på hinanden følgende dage.
English: In rabbits, reactions (from reddening to ulcerative lesions with deep loss of tissue), may occur.
Danish: Hos kaniner kan reaktioner ses (fra rødmen til ulcerative læsioner med dybtgående vævstab), som kan vare op til 17 dage efter injektionen.
English: In other species, the safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Hos andre arter er veterinærlægemidlets sikkerhed ikke fastlagt under drægtighed og diegivning.
English: A withdrawal period of 4 days following a subcutaneous injection at the recommended dose of 5 mg/kg bw is recommended based on extrapolation of the withdrawal period established for cattle milk.
Danish: Der anbefales en tilbageholdelsestid på 4 dage efter subkutan injektion af den anbefalede dosis på 5 mg/kg kropsvægt, baseret på ekstrapolation af tilbageholdelsestiden for mælk fra kvæg.
English: The safety of the veterinary medicinal product has been established in pregnant cows during the 1st quarter of pregnancy.
Danish: Lægemidlets sikkerhed under den første ¼-del af drægtigheden er fastlagt for drægtige køer.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Glass vials
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas
English: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Danish: Det bør kun anvendes i henhold til den ansvarlige dyrlæges benefit/risk-vurdering.
English: Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana))
Danish: Hunde, katte og andre eksotiske dyrearter (gnavere, kaniner, burfugle og krybdyr (slanger, skildpadder og iguanaer))
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally.
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Færdiggøres nationalt
English: Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones.
Danish: Farmakoterapeutisk gruppe: Antibakterica til systemisk brug, Fluoroquinoloner ATCvet-kode: QJ01MA90.
English: Dogs, cats, rabbits, rodents (excluded: guinea pigs, hamster), exotic animals (reptiles, avian species), pigs (piglet, pigs < 30 kg bw)
Danish: Hunde, katte, kaniner, gnavere (undtaget: marsvin, hamster), eksotiske dyr (krybdyr, fugle), svin (pattegrise, svin < 30 kg krobsvægt)
English: The product can be used in sows during lactation.
Danish: Kan anvendes under laktation.
English: Goat meat and offal (50 mg/ml and 100 mg/ml strengths) No residue depletion data were made available.
Danish: Kød og indmad fra geder (styrkerne 50 mg/ml og 100 mg/ml) Der blev ikke forelagt restkoncentrationsdata.
English: 7 CVMP public statement on the use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
Danish: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
English: Do not use in animals with known hypersensitivity to enrofloxacin or other fluoroquinolones or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af kendt overfølsomhed over for enrofloxacin, andre fluorokinoloner eller over for et eller flere af hjælpestofferne.
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af risk-benefit-forholdet.
English: Excipient: n-Butyl alcohol:
Danish: Hjælpestof (Hjælpestoffer): n-butylalkohol:
English: In cases of accidental overdoses digestive tract disorders (e.g. vomiting, diarrhoea) and neurological disorders may occur.
Danish: Ved utilsigtet overdosering kan der forekomme mave-tarm-lidelser (f.eks. opkastning, diarré) og neurologiske symptomer.
English: In reptiles and birds, muscle bruising may occur in very rare cases.
Danish: I meget sjældne tilfælde kan vævsblødninger ses hos krybdyr og fugle.
English: Special caution should be taken when using enrofloxacin in cats because higher doses than recommended can cause retinal damage and blindness (see section 4.10).
Danish: Særlig forsigtighed skal iagttages ved brug af enrofloxacin til katte, da højere dosis end anbefalet kan forårsage skade på retina og blindhed (se afsnit 4.10).
English: Birds and reptiles
Danish: Fugle og krybdyr
English: Based on the available data in sheep and with the addition of an uncertainty factor of 1.5 a goat meat and offal withdrawal period of 6 days is supported following a subcutaneous injection at the recommended dose of 5 mg/kg bw.
Danish: På grundlag af de foreliggende data hos får og med anvendelse af en usikkerhedsfaktor på 1,5 blev der fastsat en tilbageholdelsestid på 6 dage for kød og indmad fra geder efter en subkutan injektion af den anbefalede dosis på 5 mg/kg kropsvægt.
English: and Histophilus somni (50 mg/ml and 100 mg/ml strengths)
Danish: og Histophilus somni (styrkerne 50 mg/ml og
English: Bayer plc
Danish: Bayer BV
English: EXPIRY DATE
Danish: 10. UDLØBSDATO Anv.
English: In cases of accidental overdose digestive tract disorders (e.g. vomiting, diarrhoea) and neurological disorders may occur.
Danish: I tilfælde af overdosering ved hændeligt uheld, kan der forekomme symptomer fra fordøjelseskanalen (f.eks. opkast og diarré) og neurologiske reaktioner.
English: METHOD AND ROUTE(S) OF ADMINISTRATION IV, SC, IM
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) i.v, s.c., i.m.
English: In pigs, after intramuscular administration of the product, inflammatory reactions may occur.
Danish: Hos svin kan der efter intramuskulær indgift af præparatet forekomme inflammatoriske reaktioner, som kan vare op til 28 dage efter injektionen.
English: Mammals
Danish: Pattedyr
English: Pigs (25 mg/ml, 50 mg/ml and 100 mg/ml strengths) Residue depletion data were made available and supported a pig meat and offal withdrawal period of 13 days following an intramuscular administration at the recommended dose of 5 mg/kg bw.
Danish: Svin (styrkerne 25 mg/ml, 50 mg/ml og 100 mg/ml) Der blev forelagt restkoncentrationsdata, der underbyggede en tilbageholdelsestid på 13 dage for kød og indmad fra svin efter en intramuskulær administration af den anbefalede dosis på 5 mg/kg kropsvægt.