FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holders have not provided sufficient residues depletion data to allow a scientifically determined withdrawal period to be set for either turkeys or rabbits.
Danish: Indehaverne af markedsføringstilladelserne har ikke indsendt tilstrækkelige restkoncentrationsdata til at fastsætte en videnskabeligt begrundet tilbageholdelsesperiode for hverken kalkuner eller kaniner.
English: Concentrations in target tissues like lungs, liver, kidney, intestine and muscle tissue, exceed plasma concentrations by far.
Danish: Koncentrationer i væv som lunger, nyrer, tarm og muskelvæv overstiger langt koncentrationen i plasma.
English: There are not sufficient data available to set a scientifically-derived withdrawal period in rabbits, but the limited data available show that the first time point at which all residues were below the MRLs set by the CVMP was at 2 days after the final treatment.
Danish: Der foreligger ikke tilstrækkelige data til at fastsætte en videnskabeligt begrundet tilbageholdelsesperiode for kaniner, men de begrænsede foreliggende data viser, at det første givne tidspunkt, hvor alle restkoncentrationer lå under de maksimalgrænseværdier for restkoncentrationer, der var fastsat af CVMP, var to dage efter den afsluttende behandling.
English: The results of the additional studies submitted for turkeys generally supported the proposed dose rate of 10 mg/kg bodyweight.
Danish: Resultaterne af de yderligere undersøgelser, der blev forelagt for kalkuner, understøttede generelt den foreslåede dosering på 10 mg/kg legemsvægt.
English: 5, does cover the main risks associated with this product, and can be used to determine user safety warnings to appear on the product information.
Danish: 5 - omfatter alle de største risici ved dette lægemiddel og kan anvendes til at fastlægge de advarsler vedrørende brugen, der skal medtages i produktoplysningerne.
English: The marketing authorisation holders agreed to delete the following indications from the product information either due to paucity of supporting data and/or because the indications were not consistent with responsible use on fluoroquinolones: Salmonella, Streptococcus spp, Staphylococcus spp, Klebsiella, Erysipelothrix rhusiopathae.
Danish: Indehaverne af markedsføringstilladelserne indvilligede i at slette følgende indikationer i produktoplysningerne, enten fordi støttedataene var utilstrækkelige, og/eller fordi indikatorerne ikke var i overensstemmelse med en ansvarlig brug af fluoroquinoloner: Salmonella, Streptococcus spp, Staphylococcus spp, Klebsiella, Erysipelothrix rhusiopathae.
English: 1831 Diegem (Machelen) BELGIUM
Danish: Mommaertslaan 14 1831 Diegem (Machelen) BELGIEN
English: This study was also considered to be adequate to be used to set a 3-day withdrawal period for turkeys, by extrapolation from the chicken data.
Danish: Undersøgelsen blev ligeledes anset for at være tilstrækkelig til at fastsætte en tilbageholdelsesperiode på tre dage for kalkuner ved ekstrapolering af dataene vedrørende kyllinger.
English: Enrofloxacin is eliminated from the body with a total body clearance of 10.3 mL/min·kg.
Danish: Enrofloxacin udskilles fra kroppen med en total body clearance på 10,3 ml/min·kg.
English: The simultaneous application of substances containing aluminium or magnesium can impair the absorption of enrofloxacin.
Danish: Samtidig indtag af stoffer indeholdende aluminium eller magnesium kan påvirke absorptionen af enrofloxacin.
English: The first time point at which all residues were below their respective maximum residue limits in the slower-growing birds was at 3 days after final treatment, one day after the faster-growing birds.
Danish: Det første givne tidspunkt, hvor alle restkoncentrationer lå under deres respektive maksimalgrænseværdier for restkoncentrationer hos de langsommere voksende kyllinger, var tre dage efter den afsluttende behandling, en dag efter de hurtigere voksende kyllinger.
English: Because the data available was inconclusive, and furthermore because the CVMP agreed that the dose for this species should be increased, as a pragmatic approach it is proposed to retain the current 15-day withdrawal period as this will ensure consumer safety, considering the rapid depletion shown in poultry and rabbits.
Danish: Idet de foreliggende data var inkonklusive, og da CVMP derudover besluttede, at doseringen for denne art skulle forhøjes, foreslås det ud fra en pragmatisk synsvinkel at bibeholde den nuværende tilbageholdelsesperiode på 15 dage, da det vil sikre forbrugersikkerheden i lyset af det hurtige fald i restkoncentrationen hos fjerkræ og kaniner.
English: In addition, because of the concern that underdosing might encourage the development of antimicrobial resistance, the CVMP agreed to accept an increase in the dose to 10 mg/kg bodyweight during 5 days for this species in order to maintain this minor species in the product information.
Danish: På grund af bekymringen over, at en underdosering kunne fremme udviklingen af antimikrobiel resistens, gik CVMP desuden med til at godkende en forøgelse af dosis til 10 mg/kg legemsvægt i fem dage for denne art for at fastholde denne mindre art i produktoplysningerne.
English: • The marketing authorisation holders should substantiate the dosing regimen in rabbits taking into account the current MIC distribution for the target pathogens, the variability in pharmacokinetics resulting from administration of enrofloxacin via the drinking water to groups of rabbits under field conditions and with the goal to ensure sustainable effective treatment.
Danish: • Indehaverne af markedsføringstilladelserne skal begrunde doseringen for kaniner under hensyntagen til den nuværende MIC-fordeling for målpatogenerne og den forskellige farmakokinetik ved administration af enrofloxacin via drikkevandet til grupper af kaniner på feltbetingelser for at sikre en bæredygtig og effektiv behandling.
English: On 15 October 2010, the United Kingdom sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Baytril 10% oral solution and associated names.
Danish: Den 15. oktober 2010 indbragte Det Forenede Kongerige i henhold til artikel 34, stk. 1, i direktiv 2001/83/EF som ændret en sag vedrørende Baytril 10 % oral opløsning og relaterede navne til CVMP/Det Europæiske Lægemiddelagentur.
English: Belgium BAYER SA-NV J.E.
Danish: BAYER SA-NV J.E.
English: Enrofloxacin is active against many Gram-negative bacteria, against Gram-positive bacteria and Mycoplasma spp.
Danish: Enrofloxacin er aktiv mod et stort spektrum af Gram-negative bakterier, Gram-positive bakterier og Mycoplasma spp.
English: Benzyl alcohol
Danish: Hjælpestof: Benzylalkohol
English: However, it was acknowledged that the data supporting the increased dose regimen are weak, and therefore a condition should be imposed to the marketing authorisations requiring new data to substantiate the dose regimen for this species.
Danish: Det blev imidlertid anerkendt, at støttedataene for den øgede dosering var svage, og markedsføringstilladelserne skulle derfor gøres betinget af tilvejebringelsen af nye data, der dokumenterede doseringen for denne art.
English: <Manufacturer responsible for batch release:>
Danish: <Fremstiller af batchfrigivelse:>
English: To be completed nationally
Danish: Færdiggøres nationalt
English: Rates of decreased susceptibility of E. coli to ciprofloxacin based on an epidemiological cut-off of 0.06 mg/l were 19.3% in 1999-2000 and 33.5% in 2005-6.
Danish: E. coli-bakteriens lavere følsomhed over for ciprofloxacin baseret på en epidemiologisk tærskelværdi på 0,06 mg/l var 19,3 % i 1999-2000 og 33,5 % i 2005-2006.
English: If dosed as continuous drinking water medication (multiple dosing) steady-state concentrations of 0.5 mg (turkeys) to 0.8 mg (chicken) enrofloxacin per litre are achieved.
Danish: Doseres kontinuerligt via medicineret drikkevand (multipel dosering) opnås steady-state koncentrationer på 0,5 mg (kalkun) til 0,8 mg (kylling) enrofloxacin pr liter.
English: Enrofloxacin is eliminated from the body at a half-life of 6 hours.
Danish: Enrofloxacin udskilles fra organismen med en halveringstid på 6 timer.
English: The data provided to show the rate of residue depletion in chickens were also not to current standards, but they were considered to be adequate, for the purposes of this procedure, to set a 3-day meat withdrawal period for chickens.
Danish: De indsendte data vedrørende restkoncentrationen i kyllinger opfyldte heller ikke gældende standarder, men de blev anset for at være tilstrækkelige til at fastsætte en tilbageholdelsesperiode på tre dage for kyllingekød som led i denne procedure.
English: Baytril 10% oral solution and associated names are veterinary medicinal products authorised for use the target species chickens, turkeys and rabbits for treatment of the respiratory tract and of the digestive tract infections caused by identified bacteria susceptible to enrofloxacin.
Danish: Baytril 10 % oral opløsning og relaterede navne er veterinærlægemidler, som er godkendt til anvendelse i målarterne kyllinger, kalkuner og kaniner til behandling af infektioner i luftvejene og fordøjelseskanalen forårsaget af identificerede bakterier, der er følsomme over for enrofloxacin.
English: However, it has to be considered that as E coli from poultry are often resistant to first line antimicrobials, fluoroquinolones are recognised as veterinary critically important antimicrobials in the treatment of colibacillosis septicaemia and chronic respiratory disease in this species and it is important to maintain this indication on the SPC.
Danish: Det skal imidlertid understreges, at da E. coli i fjerkræ ofte er resistent over for antimikrobielle midler, der anvendes som førstelinjebehandling, er fluoroquinoloner til veterinær brug anerkendt som yderst vigtige antimikrobielle midler i behandlingen af septimæmisk colibacilliose og kroniske luftvejssygdomme hos denne art, og det er vigtigt, at denne indikation fortsat angives i produktresuméet.
English: According to the references submitted by the marketing authorisation holders, resistance rates in E. coli from chickens and turkeys are reported as low.
Danish: Ifølge de kildehenvisninger, der er blevet forelagt af indehaverne af markedsføringstilladelserne, er resistensen af E. coli i kyllinger og kalkuner lav.
English: Enrofloxacin administered via drinking water to poultry is rapidly and very well absorbed with a bioavailability of approx. 90 %.
Danish: Enrofloxacin administreret til fjerkræ via drikkevand absorberes hurtigt med en biotilgængelighed på ca. 90%.
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: Udvikling af resistens mod fluoroquinoloner er dokumenteret ved 5 mekanismer (i) punktmutation i genet der koder for DNA gyrase og/eller topoisomerase IV, hvilket forårsager forandringer i de respektive enzymer, (ii) ændring i lægemiddelpermeabiliteten hos Gram-negative bakterier, (iii) efflux mekanismer, (iv) plasmidmedieret resistens og (v) gyrasebeskyttende proteiner.
English: Turkeys: 8 days
Danish: Kalkuner: 8 døgn
English: Use only fresh pre-solutions, prepared every day before start of treatment.
Danish: Brug kun friske opblandinger, blandet dagligt før behandling.
English: The challenge studies suggested that a dose of 10 mg/kg bodyweight would be more effective than the proposed 5 mg/kg bodyweight, especially when treating acute cases.
Danish: Challenge-forsøgene viste, at en dosis på 10 mg/kg legemsvægt ville være mere effektiv end den foreslåede dosis på 5 mg/kg legemsvægt, navnlig ved behandling af akutte tilfælde.
English: However according to the EFSA/ECDC report (2012) resistance to ciprofloxacin in indicator E. coli isolates taken from chickens is described as moderate to high at a rate of 47%, although in this report, the resistance rate is based on epidemiological cut-off values for non-pathogenic strains.
Danish: (2012) beskrives resistensen over for ciprofloxacin i indikator E. coli-isolater udtaget fra kyllinger som moderat til høj (47 %), selv om resistensraten i denne rapport er baseret på epidemiologiske tærskelværdier for ikke-patogene stammer.
English: Do not use when resistance / cross-resistance to (fluoro)quinolones is known to occur.
Danish: Må ikke anvendes når det vides at resistens / krydsresistens overfor (fluoro)quinoloner kan opstå.
English: Target inhibition is caused by non-covalent binding of fluoroquinolone molecules to an intermediate state in this sequence of reactions, in which DNA is cleaved, but both strands are retained covalently attached to the enzymes.
Danish: Inhiberingen sker via en kovalent binding af flouroquinolonmolekyler til et intermediært stadie i denne reaktionssekvens, hvor DNA er spaltet, men begge strenge forbliver kovalent forbundet til enzymerne.
English: “Product name” (to be completed nationally)
Danish: ”Produkt navn” (færdiggøres nationalt)
English: For the treatment infectious diseases due to Pasteurella multocida and bacterial enteritis due to infection with E. coli.
Danish: Behandling af infektioner forårsaget af Pasteurella multocida og bakteriel enteritis forårsaget af E. coli.
English: 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: Fluoroquinoloner bør reserveres til behandling af tilfælde der har reageret dårligt eller forventes at reagere dårligt på andre antibiotika.
English: User safety warnings are included on the product information.
Danish: Advarsler vedrørende brugen er medtaget i produktoplysningerne.
English: The marketing authorisation holders confirmed that no marketing authorisation for the product relating to use in chickens or turkeys has been withdrawn, refused, revoked or suspended in any Member State.
Danish: Indehaverne af markedsføringstilladelserne bekræftede, at ingen markedsføringstilladelse for produktet vedrørende anvendelse i kyllinger eller kalkuner var blevet inddraget, afslået, tilbagekaldt eller suspenderet i nogen af medlemsstaterne.
English: The data package supports an in-use shelf life of 12 weeks and an in-use shelf life after dilution of 24 hours.
Danish: Datapakken støtter en opbevaringstid efter ibrugtagning på 12 uger og en holdbarhed efter opløsning på 24 timer.
English: Discard unused material.
Danish: Kasser ubrugt produkt.
English: The marketing authorisation holders confirmed that no marketing authorisation for the product relating to use in rabbits has been withdrawn, refused, revoked or suspended in any Member State.
Danish: Indehaverne af markedsføringstilladelserne bekræftede, at ingen markedsføringstilladelse for produktet vedrørende anvendelse i kaniner var blevet inddraget, afslået, tilbagekaldt eller suspenderet i nogen af medlemsstaterne.
English: Chicken, turkey and rabbit.
Danish: Kylling, kalkun og kanin
English: • User safety warnings;
Danish: • brugersikkerhedsadvarsler
English: 100 ml, 500 ml and 1,000 ml high density polyethylene (HDPE) bottles with an HDPE insert and a polypropylene screw closure.
Danish: 100 ml, 500 ml, og 1000 ml høj densitet polyethylen (HDPE) flasker med en HDPE indsats og et polypropylen skruelåg.
English: All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Danish: Alle mekanismer leder til en nedsat bakteriel følsomhed overfor fluoroquinoloner.
English: Although most Member States had a dose rate of 10 mg/kg for chickens and turkeys, it varied between from 2.5 mg/kg bodyweight to 10 mg/kg bodyweight for duration between 3 to 10 days.
Danish: Selv om de fleste medlemsstater havde angivet en dosering på 10 mg/kg for kyllinger og kalkuner, varierede doseringen fra 2,5 mg/kg legemsvægt til 10 mg/kg legemsvægt og varigheden fra 3 til 10 dage.
English: Baytril 10% oral solution and associated names contain 100 mg enrofloxacin per ml oral solution for use in drinking water.
Danish: Baytril 10 % oral opløsning og relaterede navne indeholder 100 mg enrofloxacin pr. ml oral opløsning til anvendelse i drikkevand.
English: No adverse clinical symptoms were observed in chickens and turkeys treated respectively with doses up to 10 and 6 times higher than the therapy dose.
Danish: Ingen negative kliniske symptomer blev observeret hos kyllinger og kalkuner behandlet med doser på respektivt 10 og 6 gange terapeutisk dosis.
English: In addition, data from the challenge studies provide evidence that a dose of 10 mg/kg bodyweight for 5 days will be tolerated in rabbits.
Danish: Data fra challenge-forsøgene dokumenterer desuden, at en dosis på 10 mg/kg legemsvægt i fem dage tolereres i kaniner.
English: coli but this was equivocally supportive of the 10 mg/kg bodyweight dose rate and also suggested that a higher dose might be preferable.
Danish: coli, men den støttede entydigt en dosering på 10 mg/kg legemsvægt, og det blev også anført, at dosis måske burde være højere.
English: Then, a distant segment of DNA is passed through this break before the strands are resealed.
Danish: Derefter passerer et fjerntliggende DNA segment gennem åbningen og strengene lukkes.
English: In doing this, CVMP recognises that an effective treatment should be kept available for E. coli, but at a future date new data will have to be generated to optimise the dose regimen for all enrofloxacin products administered orally to poultry.
Danish: CVMP anerkender således, at der bør være en effektiv behandling af E. coli, men at der på et senere tidspunkt skal tilvejebringes data for at optimere doseringen for alle enrofloxacinprodukter, der indgives oralt til fjerkræ.
English: Whenever possible fluoroquinolones should only be used based on susceptibility testing.
Danish: Hvis mulig, bør behandling med fluoroquinoloner udelukkende baseres på følsomhedstest.
English: Therefore, and considering the context of this Article 34 referral which is to harmonise the SPCs, CVMP proposed to harmonise to the highest dose rate of enrofloxacin of 10 mg/kg for 3-5 days in both chickens and turkeys, which is also that approved in the majority of Member States.
Danish: På denne baggrund og i lyset af formålet med denne indbringelsesprocedure i henhold til artikel 34, nemlig at harmonisere produktresuméerne, foreslog CVMP en harmonisering på det højeste dosisniveau, dvs. 10 mg/kg enrofloxacin i 3-5 dage, for både kyllinger og kalkuner, hvilket også er den godkendte dosis i de fleste medlemsstater.
English: User risk assessment
Danish: Vurdering af brugerrisikoen
English: 5,000 ml HDPE canister with an aluminium/HDPE seal and an HDPE screw closure.
Danish: 5000 ml HDPE beholder med aluminium/HDPE forsegling og et HDPE skruelåg.
English: Initially, both strands of the DNA double helix are cleaved.
Danish: Initialt spaltes de to strenge i DNA-dobbelthelixen.
English: They modulate the topological state of DNA through cleaving and resealing reactions.
Danish: De katalyserer DNA-replikation via spaltnings- og genlukningsreaktioner.
English: A recent paper by de Jong et al quotes data from the European Antimicrobial Susceptibility Surveillance in Animals (EASSA) collected from EU countries.
Danish: European Antimicrobial Susceptibility Surveillance in Animals (EASSA), der er indsamlet fra EUlandene.
English: Regarding the indications for P. multocida and E. coli for rabbits, it was agreed that with an increase to the dose, the benefit-risk for this minor species would remain positive, however a condition should be imposed to the marketing authorisations requiring new data to substantiate the dose regimen for this species.
Danish: Med hensyn til indikationerne for P. multocida og E. coli hos kaniner nåede udvalget til enighed om, at selv om dosis blev forhøjet, ville benefit/risk-forholdet for denne mindre art fortsat være positivt, men markedsføringstilladelserne skulle imidlertid gøres betinget af tilvejebringelsen af nye data, der dokumenterede doseringen for denne art.
English: Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of E. coli to fluoroquinolones and emergence of resistant organisms.
Danish: Siden enrofloxacin først blev godkendt til brug hos fjerkræ, har der været en udtalt reduktion i følsomheden af E.coli overfor fluoroquinoloner og fremkomst af resistente organismer.
English: Although some concern remains that the dose regimen may not be optimal for the treatment of E. coli, and with regard to limiting the risk for the development of antimicrobial resistance, it is recognised that enrofloxacin is critically important for the treatment of colibacillosis in poultry.
Danish: Selv om udvalget fortsat er betænkelig ved doseringen, der måske ikke er optimal for behandlingen af E. coli og for minimeringen af risikoen for udvikling af antimikrobiel resistens, anerkendes det, at enrofloxacin er et yderst vigtigt lægemiddel til behandling af colibacilliose i fjerkræ.
English: To be completed nationally {Name and address} <{Tel}> <{Fax}> <{E-mail}>
Danish: Færdiggøres nationalt {Navn og adresse} <{tfl.
English: In this situation, as the rabbit is a minor species, the assessment for broilers covers the use of the product in rabbits and the risk assessment can stop at Phase I.
Danish: I denne situation omfatter vurderingen af slagtekyllinger brugen af lægemidlet i kaniner, da kaniner er en mindre art, og risikovurderingen kan således indstilles i fase I.
English: <Marketing authorisation holder <and manufacturer responsible for batch release>:
Danish: <Indehaver af markedsføringstilladelsen <og fremstiller af batchfrigivelse>:
English: Enrofloxacin
Danish: Aktivt stof: Enrofloxacin
English: Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the active substance of choice.
Danish: Enrofloxacin bør anvendes når klinisk erfaring, hvor muligt støttet af følsomhedstest for den aktuelle organisme, tyder på at enrofloxacin er den bedste aktive substans.
English: Potassium hydroxide Purified water.
Danish: Benzylalkohol Kaliumhydroxid Vand renset
English: 10 mg enrofloxacin/kg bodyweight per day for 3-5 consecutive days.
Danish: 10 mg enrofloxacin/kg legemsvægt daglig i 3-5 på hinanden følgende dage.
English: • the CVMP considered the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet;
Danish: • CVMP var af den opfattelse, at formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen
English: Condition of the marketing authorisations
Danish: Betingelse for markedsføringstilladelserne
English: In vitro, an antagonism was shown, when combining fluoroquinolones with bacteriostatic antimicrobial agents such as macrolides or tetracyclines and phenicols.
Danish: Antagonisme er påvist in-vitro når fluoroquinoloner kombineres med bakteriostatiske antimikrobielle midler som macrolider, tetracykliner eller fenicoler.
English: Bottles of 100, 500 and 1,000 ml or canister of 5,000 ml.
Danish: Flasker af 100, 500, 1000 og 5000 ml
English: For chickens and turkeys, please refer to section 8.
Danish: For kyllinger og kalkuner, venligst se afsnittet Dosering for hver dyreart.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Danish: Videnskabelige konklusioner og begrundelser for ændring af produktresumé, etikettering og indlægsseddel
English: The risks for the environment have been assessed previously for a dose of 10 mg/kg bodyweight for 10 consecutive days in broiler chickens.
Danish: Miljørisiciene er blevet vurderet tidligere for indgivelse af en dosis på 10 mg/kg legemsvægt i 10 dage i træk i slagtekyllinger.
English: Those with known hypersensitivity to (fluoro)quinolones should avoid contact with this product.
Danish: Personer med kendt overfølsomhed overfor fluoroquinoloner, bør undgå kontakt med dette produkt.