FrancophonIA/ELRC3.0 huggingface dataset:
English: The EC50 based on the final exposure concentration can be estimated to be 4.9 µg/l when considering the EC50 of 49 µg/l based on the nominal start concentration (equal to 100% recovery) and an average recovery of 10% of the nominal concentration (mean of the range 0 to 20%).
Danish: EC50 baseret på den endelige eksponeringskoncentration kan estimeres til 4,9 µg/l, når man går ud fra en EC50 på 49 µg/l baseret på den nominelle startkoncentration (svarende til 100 % genfinding) og en indledende gennemsnitlig genfinding på 10 % af den nominelle koncentration (gennemsnit i området 0 til 20 %).
English: Although not following the recommended OECD guideline, the results are sufficient to demonstrate that enrofloxacin is not likely to pose any risk to fish.
Danish: Selvom resultaterne ikke følger den anbefalede OECD-retningslinje, er resultaterne tilstrækkelige til at påvise, at det ikke er sandsynligt, at enrofloxacin udgør nogen risiko for fisk.
English: A study taken from the open literature, Robinson et al. (2005)2, studied the toxicity of enrofloxacin to algae Microcystis aeruginosa (cyanobacteria or blue-green algae) and Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum, green alga).
Danish: En publiceret undersøgelse, Robinson et al. (2005)2, undersøgte enrofloxacins toksicitet for algerne Microcystis aeruginosa (cyanobakterier eller blågrønalger) og Pseudokirchneriella subcapitata (tidligere Selenastrum capricornutum, grønalger).
English: The effect of enrofloxacin on the emergence and growth of terrestrial plant seedlings was investigated.
Danish: Effekten af enrofloxacin på fremkomst og vækst af terrestriske kimplanter blev undersøgt.
English: An earthworm reproduction test according to OECD guideline 222 was performed.
Danish: Der blev foretaget en reproduktionstest for regnorme ifølge OECD-retningslinje 222.
English: However, it is the view of the CVMP, that a margin of more than 800 between the estimated PECsw (0.019 µg/l) and the EC50 calculated on the basis of the data in the Robinson et al paper (15.9 µg/l) indicates a very low exposure to cyanobacteria as a result of the use of this product, and gives reassurance that the actual risk to cyanobacteria is acceptable.
Danish: Det er imidlertid CVMP's synspunkt, at en margin på mere end 800 mellem den estimerede PECov (0,019 µg/l) og EC50 beregnet på basis af data i Robinson et alundersøgelsen (15,9 µg/l) tyder på en meget lav eksponering for cyanobakterier efter brug af dette produkt.
English: Higher tier modelling has furthermore revealed a negligible risk for ground water contamination.
Danish: Desuden har ”higher tier”-modeller også vist en forsvindende lille risiko for kontaminering af grundvand.
English: Enro-K 10% Oral Solution
Danish: Enro-K 10 % Oral Opløsning Oral opløsning 100 mg/ml
English: The test follows the recommended test guideline with no major deviation and was conducted in compliance with GLP.
Danish: Testen følger uden større afvigelser den anbefalede test-retningslinje og blev foretaget i overensstemmelse med GLP.
English: 2.1.3 Soil degradation
Danish: 2.1.3 Jordnedbrydning
English: There was no concentration dependent effect on seedling emergence due to enrofloxacin up to the highest concentration tested.
Danish: Enrofloxacin havde ingen koncentrationsafhængig virkning på kimplanternes fremkomst op til den højeste testede koncentration.
English: The plant test follows the recommended test guideline with no major deviation and was conducted in compliance with GLP.
Danish: Plantetesten følger uden større afvigelser den anbefalede test-retningslinje og blev foretaget i overensstemmelse med GLP.
English: The CVMP is of the opinion that the provided information on toxicity to cyanobacteria is insufficient for a full risk characterisation, as the information found in the peer reviewed paper by Robinson et al 2005, does not allow for a full assessment of e.g. the validity of data and the exposure concentration.
Danish: CVMP er af den opfattelse, at den fremlagte information om toksicitet for cyanobakterier ikke er tilstrækkelig til en fuld risikokarakterisering, da oplysningerne fra den peer review-bedømte Robinson et al 2005 undersøgelse ikke gør det muligt at foretage en fuld bedømmelse af f.eks. validiteten af data og eksponeringskoncentrationen.
English: Invented name Pharmaceutical form
Danish: Handelsnavn Lægemiddelform Styrke
English: Strength Animal species
Danish: Dyrearter
English: The CVMP concluded that the provided information on toxicity to cyanobacteria is insufficient for a full risk characterisation, as the information found in the peer reviewed paper by Robinson et al 2005 does not allow for a full assessment of e.g. the validity of data and the exposure concentration.
Danish: CVMP konkluderede, at den fremlagte information om toksicitet for cyanobakterier ikke er tilstrækkelig til en fuld risikokarakterisering, da oplysningerne fra undersøgelsen af Robinson et al 2005 med peer review ikke gør det muligt at foretage en fuld bedømmelse af f.eks. validiteten af data og eksponeringskoncentrationen.
English: Although not following the recommended OECD guideline, the results are sufficient to demonstrate that enrofloxacin is not likely to pose any risk to aquatic invertebrates.
Danish: Selvom resultaterne ikke følger den anbefalede OECD-retningslinje, er resultaterne tilstrækkelige til at påvise, at det ikke er sandsynligt, at enrofloxacin udgør nogen risiko for hvirvelløse vanddyr.
English: However, a margin of more than 800 between the estimated PECsw and the EC50 calculated on the basis of the data in the Robinson et al paper indicates a very low exposure to cyanobacteria as a result of the use of this product, and gives reassurance that the actual risk to cyanobacteria is acceptable.
Danish: En margin på mere end 800 mellem estimeret PECov og EC50 beregnet på basis af data i Robinson et al-undersøgelsen tyder på en meget lav eksponering for cyanobakterier efter brug af dette produkt.
English: Germany Laboratorios Karizoo S.A. Mas Pujades
Danish: Tyskland Laboratorios Karizoo S.A. Mas Pujades
English: 2.2.3 PECsurfacewater (PECsw)
Danish: 2.2.3 PECoverfladevand (PECov)
English: 2.3.3 Fish Robinson et al. (2005)2 studied the toxicity of enrofloxacin to Pimephales promelas (fathead minnow).
Danish: Robinson et al. (2005)2 undersøgte enrofloxacins toksicitet over for Pimephales promelas (elritse).
English: Some of the data are new studies conducted according to the recommended OECD guidelines and in compliance with GLP, those studies were performed following questions raised during the Decentralised Procedure.
Danish: Nogle af disse data er fra nye undersøgelser, som er udført i overensstemmelse med de anbefalede OECD-retningslinjer, og som overholder GLP.
English: Using this PNEC value and the PECsoil established above (542.9 µg/kg) a risk quotient of 0.44 can be established for plants.
Danish: Med denne PNEC-værdi og den ovenfor fastlagte PECjord (542,9 µg/kg) kan der fastlægges en risikokvotient på 0,44 for planter.
English: 4 Knapp CW, Cardoza LA, Hawes JN, Wellington EMH, Larive CK, Graham DW.
Danish: Knapp CW, Cardoza LA, Hawes JN, Wellington EMH, Larive CK, Graham DW. Fate and Effects of Enrofloxacin in Aquatic Systems under Different Light Conditions.
English: 2.3.2 Aquatic invertebrates (Daphnia magna) Robinson et al. (2005)2 studied the toxicity of enrofloxacin to Daphnia magna (waterflea).
Danish: Robinson et al. (2005)2 undersøgte enrofloxacins toksicitet over for Daphnia magna (dafnie).
English: 2.3.6 Earthworms
Danish: 2.3.6 Regnorme
English: Using this PNEC value and the PECsw established above (0.019 µg/l) a risk quotient of less than 0.01 can be established for fish.
Danish: Med denne PNEC-værdi og den ovenfor fastlagte PECov (0,019 µg/l) kan der fastlægges en risikokvotient på mindre end 0,01 for hvirvelløse fisk.
English: Using this PNEC value and the PECsoil established above (542.9 µg/kg) the risk quotient can be concluded to be far below 1 for earthworms.
Danish: Med denne PNEC-værdi og den ovenfor fastlagte PECjord (542,9 µg/kg) kan det konkluderes, at risikokvotienten er langt under 1 for regnorme.
English: Using this PNEC value and the PECsw established above (0.019 µg/l) a risk quotient of less than 0.01 can be established for aquatic invertebrates.
Danish: Med denne PNEC-værdi og den ovenfor fastlagte PECov (0,019 µg/l) kan der fastlægges en risikokvotient på mindre end 0,01 for hvirvelløse vanddyr.
English: These signs resolve within a few minutes.
Danish: Disse tegn forsvinder inden for få minutter.
English: ATCvet code: QJ01FA94.
Danish: ATCvet-kode: QJ01FA94.
English: The active substance in Draxxin is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substans i Draxxin er godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: MLSB resistance may be constitutive or inducible.
Danish: MLSB resistens kan være konstitutiv eller induktiv.
English: Antiinfectious agents/ Antibiotics'
Danish: Antismitstoffer/ Antibiotika
English: Date of first authorisation: 11/11/2003.
Danish: Dato for første markedsføringstilladelse: 11/11/2003.
English: To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre korrekt dosering skal legemsvægten bestemmes så præcist som muligt for at undgå underdosering.
English: Draxxin should only be used if pigs are expected to develop the disease within 2-3 days.
Danish: Draxxin må kun anvendes til svin, som forventes at udvikle sygdommen inden for 2-3 dage.
English: The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Danish: Den periodiske, opdaterede sikkerhedsindberetninger (PSUR) cyklus bør nulstilles før indsendelse af 6 månedlige rapporter (der dækker alle godkendte pakningsstørrelser af produktet) for de næste to år, efterfulgt af årlige rapporter for de efterfølgende to år og derefter med 3 års mellemrum.
English: Tulathromycin is irritating to eyes.
Danish: Tulathromycin er irriterende for øjnene.
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Danish: Den officielle nationale og regionale politik om antimikrobielle midler skal tages i betragtning ved brugen af veterinærlægemidlet.
English: Tulathromycin (2R, 3S, 4R, 5R, 8R, 10R,
Danish: Tulathromycin (2R, 3S, 4R, 5R, 8R, 10R, 11R,
English: Special warnings for sheep:
Danish: Særlige advarsler for får:
English: They act by stimulating the dissociation of peptidyl-tRNA from the ribosome during the translocation process.
Danish: De virker ved at stimulere spaltningen af peptidyl-tRNA fra ribosomerne under translokationsprocessen.
English: Date of last renewal: 19/09/2008.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 19/09/2008.
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Cross resistance occurs with other macrolides.
Danish: Krydsresistens med andre macrolider forekommer.
English: Antibiotic treatment of benign foot rot is not considered appropriate.
Danish: Antibiotikabehandling af godartet klovsyge anses ikke for hensigtsmæssigt.
English: If a hypersensitivity reaction occurs appropriate treatment should be administered without delay.
Danish: Hvis der forekommer en overfølsomhedsreaktion, skal der øjeblikkeligt gives passende behandling.
English: If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.
Danish: Hvis de kliniske tegn på luftvejsinfektion fortsætter eller forværres, eller hvis der er tilbagefald, så bør der behandles med et andet antibiotikum og fortsættes hermed indtil de kliniske tegn er forsvundet.
English: 29 route des Industries 37530 Pocé-sur-Cisse
Danish: 29 route des Industries 37530 Pocé-sur-Cisse FRANKRIG
English: Pharmacotherapeutic group: Antibacterials for systemic use, macrolides.
Danish: Farmakoterapeutisk gruppe: Antibakterica til systemisk brug, macrolider.
English: Resistance may be chromosomal or plasmid-encoded and may be transferable if associated with transposons or plasmids.
Danish: Resistens kan være kromosomal eller plasmidkodet og kan blive overført i forbindelse med transposomer eller plasmider.
English: Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment.
Danish: Behandling af klovsyge bør derfor foretages sammen med andre redskaber til besætningsstyring som f.eks. at sørge for tørre omgivelser.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Lameness was also observed when the hind leg was used as the injection site.
Danish: Halthed blev også observeret, når bagbenet var brugt som injektionssted.
English: Plasma protein binding was approximately 60-75%.
Danish: Plasmaproteinbindingen var ca. 60-75%.
English: It lowers the production of the pro-inflammatory mediators leukotriene B4 and CXCL-8 and induces the production of anti-inflammatory and pro-resolving lipid lipoxin A4.
Danish: Det nedsætter produktionen af de pro-inflammatoriske mediatorer leukotrien B4 og CXCL-8 og inducerer produktion af det antiinflammatoriske og pro-opløsende lipid lipoxin A4.
English: The efficacy of antimicrobial treatment of foot rot might be reduced by other factors, such as wet environmental conditions, as well as inappropriate farm management.
Danish: Virkningen af antimikrobiel behandling af klovsyge kan nedsættes af andre faktorer såsom våde omgivelser såvel som uhensigtsmæssig driftsledelse.
English: Cattle: For subcutaneous use.
Danish: Kvæg: Subkutan anvendelse.
English: Cattle, pigs and sheep
Danish: Kvæg, svin og får
English: Muscle Skin and fat in natural proportions Liver
Danish: Muskel Hud og fedt i naturligt forhold Lever Nyre
English: Pigs and sheep: For intramuscular use.
Danish: Svin og får: Intramuskulær anvendelse.
English: Plasma protein binding was low, approximately 40%.
Danish: Plasmaproteinbindingen var lav, omkring 40 %.
English: Use of the product should be based on susceptibility testing of the bacteria isolated from the animal.
Danish: Behandling skal baseres på følsomhedstest af bakterien isoleret fra dyret.
English: Manufacturers responsible for batch release: FAREVA AMBOISE
Danish: Fremstillere ansvarlig for batchfrigivelse: FAREVA AMBOISE Zone Industrielle,
English: It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection.
Danish: Det anbefales at behandle dyrene i den tidlige fase af sygdomsforløbet og at vurdere virkningen indenfor 48 timer efter injektionen.
English: There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages.
Danish: Der er en stærk evidens for en betydelig akkumulation af tulathromycin i neutrofile og alveolære makrofager.
English: Increased minimum inhibitory concentration (MIC) values have been found in some isolates of Histophilus somni and Actinobacillus pleuropneumoniae.
Danish: Forhøjede værdier af den mindste hæmmende koncentration (MIC) er fundet i nogle isolater af Histophilus somni og Actinobacillus pleuropneumoniae.
English: Draxxin 100 mg/ml: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANCE
Danish: Draxxin 100 mg/ml: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANKRIG
English: In addition to its antimicrobial properties, tulathromycin demonstrates immune-modulating and antiinflammatory actions in experimental studies.
Danish: Ud over de antimikrobielle egenskaber udviser tulathromycin immunmodulerende og antiinflammatoriske virkninger i eksperimentelle studier.
English: Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a fermentation product.
Danish: Tulathromycin er et semisyntetisk macrolidt antimikrobielt stof, som kommer fra et fermenterings produkt.
English: Tulathromycin may cause sensitisation by skin contact.
Danish: Tulathromycin kan give sensibilisering ved hudkontakt.
English: Pigs: 13 days.
Danish: Svin: 13 dage.
English: Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Danish: Laboratoriestudier med rotter og kaniner har ikke vist nogle teratogene, føtotoxiske eller maternotoxiske egneskaber.
English: Cattle: 22 days.
Danish: Kvæg: 22 dage.
English: Draxxin showed limited efficacy in sheep with severe clinical signs or chronic foot rot, and should therefore only be given at an early stage of foot rot.
Danish: Draxxin har vist begrænset virkning hos får med svære kliniske tegn eller kronisk klovsyge og bør derfor kun gives i tilfælde af tidlige faser af klovsyge.
English: Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA.
Danish: Macrolider er bakteriostatiske antibiotika og hæmmer vigtige protein biosynteser takket være den selektive binding til bakterielt ribosom RNA.
English: Vall de Bianya 17813 (Gerona) SPAIN
Danish: Vall de Bianya 17813 (Girona) SPANIEN
English: Sheep: 16 days.
Danish: Får: 16 dage.
English: However, the in vivo concentration of tulathromycin at the infection site of the lung is not known.
Danish: In vivo koncentrationen af tulathromycin på infektionsstedet i lungerne er ikke kendt.
English: Subcutaneous administration of Draxxin to cattle causes very commonly transient pain reactions and local swellings at the injection site that can persist for up to 30 days.
Danish: Subkutan applikation af Draxxin til kvæg forårsager ofte forbigående smertereaktion og lokal hævelse på injektionsstedet, som kan vedvare i op til 30 dage.
English: For any respiratory disease, it is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection.
Danish: Ved alle luftvejsinfektioner anbefales det at behandle dyrene i den tidlige fase af sygdomsforløbet og at vurdere virkningen indenfor 48 timer efter injektionen.
English: In case of accidental spillage onto skin, wash the skin immediately with soap and water.
Danish: I tilfælde af kontakt med huden ved hændeligt uheld, bør det berørte område vaskes omgående med sæbe og vand.
English: Draxxin 25 mg/ml: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM
Danish: Draxxin 25 mg/ml: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIEN
English: Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma.
Danish: Tulathromycin koncentrationer i lungehomogenat var betydeligt større end i plasma.
English: 500 ml vials must not be used for pigs and sheep.
Danish: 500 ml beholder må ikke bruges til svin og får.
English: Use only according 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: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLERE ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: No such reactions have been observed in pigs and sheep after intramuscular administration.
Danish: En sådan reaktion har ikke været observeret hos svin og får efter intramuskulær injektion.
English: Do not use simultaneously with other macrolides or lincosamides.
Danish: Bør ikke anvendes samtidigt med andre macrolider eller lincosamider.
English: Primary packaging: Type I glass vial with a fluoropolymer coated chlorobutyl stopper and an aluminium overseal.
Danish: Primær pakning: Type I hætteglas med en fluoropolymercoated chlorobutyl gummiprop og aluminiumsforsegling.
English: In both bovine and porcine polymorphonuclear cells (PMNs; neutrophils), tulathromycin promotes apoptosis (programmed cell death) and the clearance of apoptotic cells by macrophages.
Danish: I både bovine og porcine polymorfonukleære celler (PMN'er, neutrofiler) fremmer tulathromycin apoptose (programmeret celledød) og nedbrydning af apototiske celler af makrofager.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: The presence of the disease in the herd should be established before metaphylactic treatment.
Danish: Tilstedeværelse af sygdommen i besætningen skal være konstateret før metafylaktisk behandling.
English: The safety of tulathromycin during pregnancy and lactation has not been established in cattle and pigs.
Danish: Lægemidlets sikkerhed under drægtighed og laktation er ikke klarlagt for kvæg og svin.
English: Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Danish: Må ikke administreres samtidig med antimikrobielle midler med samme virkningsmekanisme såsom macrolider og lincosamider.
English: It differs from many other macrolides in that it has a long duration of action that is, in part, due to its three amine groups; therefore it has been given the chemical subclass designation of triamilide.
Danish: Det udskiller sig fra mange andre macrolider ved den lange virkningstid som delvis skyldes de tre aminogrupper.
English: Tulathromycin also possesses in vitro activity against Moraxella bovis, the bacterial pathogen most commonly associated with infectious bovine keratoconjunctivitis (IBK).
Danish: Tulathromycin er også aktivt in vitro mod Moraxella bovis, den patogene bakterie, som oftest forårsager Infektiøs Bovin Keratokonjunktivitis (IBK).
English: 14R)-2-ethyl tetrahydroxy hexamethyl trideoxy-3(dimethylamin o)-ß-Dxylohexopyranosyl]oxy]-1oxa-6azacyclopentde-can-15-one expressed as tulathromycin equivalents
Danish: (dimethylamino)ß-Dxylohexopyranosy l]oxy]-1-oxa-6azacyclopentadec an-15-one, udtrykt som tulathromycinækvivalenter
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på fremstillerene ansvarlig for batchfrigivelse