FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall benefit-risk balance for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I) is deemed positive subject to the recommended changes in the product information (see annex III) and, in view of the need to obtain further data in order fully to address the public health issues that have given rise to this referral procedure, subject to the imposition of conditions affecting the Marketing Authorisations (see annex IV).
Danish: Det overordnede benefit/risk-forhold for veterinærlægemidler indeholdende enrofloxacin til administration gennem drikkevandet til kyllinger og/eller kalkuner (se bilag I) anses for positivt under forudsætning af de anbefalede ændringer i produktinformationen (se bilag III) og - da der kræves flere data for fuldt at imødegå de folkesundhedsproblemer, som har udløst denne indbringelsesprocedure - under forudsætning af, at der fastsættes visse betingelser for markedsføringstilladelserne (se bilag IV).
English: There is a wide mutant selection window between 0.06 and 4 µg/ml which supports the fact that the pathogenic strain could not be eradicated after treatment with even a high dose of enrofloxacin.
Danish: 0,06 til 4 µg/ml er et bredt vindue for selektion af mutationer, hvilket kan forklare, at den patogene stamme ikke kunne udryddes, selv efter behandling med en høj dosis enrofloxacin.
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 anvendelse hos fjerkræ, har der været et udtalt fald i følsomheden af E.coli over for fluorquinoloner, og der er udviklet resistente organismer.
English: Field studies conducted in 1997-1998 showed that an inclusion rate of 50 ppm reduced clinical signs but the pathogen was not eliminated.
Danish: Fem undersøgelser, der blev udført i perioden 1997-1998, viste, at et iblandingsforhold på 50 ppm reducerede de kliniske symptomer, men at patogenet ikke blev udryddet.
English: In the more recent laboratory study (2007) which simulated field conditions, turkeys were administered enrofloxacin at 10 mg/kg bw for 5 days, but the re-isolation rate was not investigated.
Danish: I den nyere laboratorieundersøgelse (2007), der simulerede feltbetingelser, blev enrofloxacin administreret til kalkuner i en dosering på 10 mg/kg kropsvægt i fem dage, men andelen af reisolation blev ikke undersøgt.
English: Romania DIVASA - FARMAVIC, S.A. Ctra Sant Hipolit Km 71
Danish: Rumænien DIVASA - FARMAVIC, S.A. Ctra Sant Hipolit Km 71
English: Turkeys: Meat and offal: 13 days.
Danish: Kalkuner: Kød og indmad: 13 dage.
English: 5804 CG Venray The Netherlands
Danish: 5804 CG Venray
English: • Breed of bird used in the study; faster-growing or slower-growing; different metabolism;
Danish: • Den i undersøgelsen anvendte fuglerace, mere eller mindre hurtigvoksende, forskellig metabolisme.
English: Mommaertslaan 14 B-1831 Diegem (Machelen) Belgium
Danish: Mommaertslaan 14 B-1831 Diegem (Machelen) Belgien
English: The one reference conducted in the EU
Danish: Den ene undersøgelse, der var
English: The MIC50 and MIC90 values of the E coli isolates were 1 and 32 mg/L, respectively, which results in Cmax/MIC and AUC/MIC parameters considerably below the breakpoints for fluoroquinolones.
Danish: MIC50- og MIC90-værdierne for isolaterne af E.coli var hhv. 1 og 32 mg/l, hvilket betyder, at Cmax/MIC- og AUC/MIC-forholdene er væsentligt under de fastlagte breakpoints for fluorquinoloner.
English: This proposal would ensure the safety of consumers of meat and offal taken from chickens and turkeys treated with the veterinary medicinal products containing enrofloxacin for administration via drinking water to chickens and turkeys at the recommended dose of 10 mg/kg bw/day for 5 consecutive days.
Danish: Dette forslag vil garantere sikkerheden for forbrugerne af kød og indmad fra kyllinger og kalkuner, der er behandlet med veterinærlægemidler indeholdende enrofloxacin efter administration gennem drikkevandet til kyllinger og kalkuner i den anbefalede dosis på 10 mg/kg kropsvægt i 5 på hinanden følgende dage.
English: Tolerance data from 2009 show that at doses of 300 and 600 mg enrofloxacin /kg bw administered once or for 5 days to 21 day old broiler chickens, diarrhoea and abnormal behaviour such as reluctance to move, reduced motor activity and disturbed coordination of movement were seen.
Danish: Tolerancedata fra 2009 viser, at når enrofloxacin i doser på 300 og 600 mg/kg kropsvægt blev administreret som enkeltdosis eller i 5 dage til 21 dage gamle slagtekyllinger, iagttoges diarré og abnorm adfærd såsom utilbøjelighed til at bevæge sig, nedsat motorisk aktivitet og svækket koordination af bevægelser.
English: Fluoroquinolones are recognised as veterinary critically important antimicrobials in the treatment of colibacillosis septicaemia and chronic respiratory disease in poultry.
Danish: Fluorquinoloner er anerkendt som veterinære antibiotika af afgørende betydning for behandlingen af coli-septikæmi og kronisk luftvejssygdom hos fjerkræ.
English: It should be noted that levels of enrofloxacin in the lungs of chickens have been consistently reported as 0.88 µg/g after chickens have been dosed with enrofloxacin at 10 mg/kg bw.
Danish: Det bør bemærkes, at koncentrationerne af enrofloxacin i kyllingernes lunger vedvarende er blevet angivet til 0,88 µg/g efter dosering med enrofloxacin, 10 mg/kg kropsvægt.
English: Crta de Castellvell, 24 43206 Reus (Tarragona) Spain
Danish: Crta de Castellvell, 24 43206 Reus (Tarragona) Spanien
English: Laboratorios Maymo, S.A., Via Augusta 302, 08017 Barcelona Spain
Danish: Laboratorios Maymo, S.A., Via Augusta 302, 08017 Barcelona Spanien
English: Rue 13eme Rue 06511 Carros Cedex, France
Danish: Rue 13eme Rue 06511 Carros Cedex, Frankrig
English: s r.o., Murgašova 5, 949 01 Nitra, Slovakia
Danish: s r.o., Murgašova 5, 949 01 Nitra, Slovakiet
English: The withdrawal periods should be set 7 days for chickens and 13 days for turkeys to ensure consumer safety at the recommended dose of 10 mg/kg bw/day for 5 consecutive days
Danish: Tilbageholdelsestiden bør sættes til 7 dage for kyllinger og 13 dage for kalkuner for at sikre forbrugerne ved den anbefalede dosering på 10 mg /kg kropsvægt i 5 på hinanden følgende dage.
English: The CVMP also considered the possibility that there were significant formulation differences between the products that might account for the variability in metabolism and depletion due to potential bioavailability differences; however, the formulations of all the products concerned are very similar, containing similar excipients.
Danish: CVMP overvejede desuden, om der kunne være væsentlige formuleringsbetingede forskelle som årsag til variabiliteten i metabolisering og depletion betinget af potentielle forskelle i biotilgængelighed.
English: The study by Evans at al (2009)17 concluded that in the UK humans infected with fluoroquinoloneresistant Campylobacter did not suffer a more severe disease than those infected with susceptible Campylobacter even when use of antimicrobials is taken into account, however the authors did not state if there was any impact on specific vulnerable sub-groups.
Danish: Undersøgelsen udført af Evans at al (2009)17 konkluderede, at i Det Forenede Kongerige fik personer, der var smittet med fluorquinolon-resistente Campylobacter, ikke sværere sygdom end de, der var smittet med følsomme Campylobacter, selv når anvendelse af antibiotika tages i betragtning.
English: 08620 Sant Vicenc del Horts, Barcelona Spain
Danish: 08620 Sant Vicenc del Horts, Barcelona Spanien
English: 08041 Barcelona Spain
Danish: 08041 Barcelona Spanien
English: Bayer d.o.o., Bravničarjeva 13 Ljubljana Slovenia
Danish: Slovenien Bayer d.o.o., Bravničarjeva 13
English: All products are administered at the dose of 10 mg enrofloxacin per kg body weight (bw).
Danish: Alle produkterne administreres i en dosis af 10 mg enrofloxacin/kg kropsvægt.
English: CENAVISA, S.A., Cami Pedra Estela s/n, 43205 Reus (Tarragona) Spain
Danish: CENAVISA, S.A., Cami Pedra Estela s/n, 43205 Reus (Tarragona) Spanien
English: A further field study conducted in the EU demonstrated that dose rates up to 20.6 mg/kg bw again controlled signs but did not eliminate the pathogen.
Danish: En yderligere feltundersøgelse, der blev udført i EU, viste, at en dosering på op til 20,6 mg/kg kropsvægt kontrollerede symptomerne, men ikke eliminerede patogenet.
English: Another study demonstrated that a dose rate of 12.52 mg/kg bw administered for 3 days controlled signs of disease but did not eliminate the pathogen.
Danish: Endnu en yderligere undersøgelse viste, at en dosering på 12,52 mg/kg kropsvægt administreret i tre dage kontrollerede sygdomstegnene, men ikke udryddede patogenet.
English: Fluoroquinolones are recognised as veterinary critically important antimicrobials in the treatment of colibacillosis septicaemia and chronic respiratory disease in poultry with few effective alternatives, therefore the indication should be maintained.
Danish: Fluorquinoloner er anerkendt som veterinære antibiotika med kritisk betydning ved behandling af coliseptikæmi og kronisk luftvejssygdom hos fjerkræ, og da der er få effektive alternativer, bør indikationen opretholdes.
English: Chickens: Meat and offal: 7 days.
Danish: Kyllinger: Kød og indmad: 7 dage.
English: The 2009 experimental study (using a susceptible E.coli isolate) showed that a daily dose of 10 mg/kg bw for 5 days was more effective at controlling disease and reducing E.coli re-isolation compared to the total dose (50 mg/kg bw) administered over a 20 hours period when E.coli was detected in the trachea 4 days after the onset of treatment.
Danish: Den eksperimentelle undersøgelse fra 2009 (med et følsomt isolat af E.coli) viste, at en daglig dosis på 10 mg /kg kropsvægt i fem dage var mere effektiv til at kontrollere sygdommen og reducere reisolation af E.coli, end når den samlede dosis (50 mg/kg kropsvægt) blev administreret i løbet af 20 timer, når der blev påvist E.coli i trachea fire dage efter påbegyndelse af behandlingen.
English: Two studies conducted in 1997 and 2002 both demonstrated that when birds were infected with E.coli with reduced susceptibility, MIC=0.5 µg/ml, the efficacy of 10 mg/kg enrofloxacin was reducedclinical signs were less well controlled and in one study mortality was approximately 43%.
Danish: To undersøgelser fra 1997 og 2002 viste begge, at når fuglene blev inficeret med E.coli med nedsat følsomhed (MIC= 0,5 µg/ml) var virkningen af 10 mg/kg enrofloxacin forringet - de kliniske tegn var mindre velkontrollerede, og i den ene undersøgelse var dødeligheden ca. 43 %.
English: Belgium Bayer SA-NV J.E.
Danish: Bayer SA-NV J.E.
English: Apart from mutant selection windows, other features of enrofloxacin also promote the selection of resistant strains.
Danish: Foruden gennem vinduer for selektion af mutationer fremmes selektion af resistente stammer af andre egenskaber ved enrofloxacin.
English: • on the basis of the available data, the CVMP considered that the current dosing regimen for E. coli infections is not optimised in terms of efficacy or limiting the development of resistance in this target pathogen;
Danish: • på grundlag af de foreliggende data fandt CVMP, at det nuværende doseringsregime ved infektion med E. coli ikke er optimeret hvad angår virkning eller begrænsning af resistensudvikling hos denne målpatogen
English: 12 Population PK and PK/PD investigations and Monte Carlo simulations for a rational dose regimen.
Danish: Food and Chemical Toxicology 49:1530-1536 12 Population PK and PK/PD investigations and Monte Carlo simulations for a rational dose regimen.
English: DOX-AL Italia S.p.A. Largo Donegani 2 20121 Milano Italy
Danish: Largo Donegani 2 20121 Milano Italien
English: When site of infection lung levels of enrofloxacin of 0.84 µg/g are considered, against the same pathogen, Cmax/MIC is far below the clinically predictive value of 8.
Danish: Idet der regnes med en koncentration af enrofloxacin på infektionsstedet, lungerne, på 0,84 µg/g, er Cmax/MICforholdet for samme patogen langt under den klinisk prædiktive værdi på 8.
English: 06511 Carros cedex France
Danish: 06511 Carros cedex Frankrig
English: Ceva Santé Animale, 10 avenue de La Ballastière, 33500 Libourne France
Danish: Ceva Santé Animale, 10 avenue de La Ballastière, 33500 Libourne Frankrig
English: Available online at www.efsa.europa.eu/efsajournal for non-pathogenic strains.
Danish: Available online at www.efsa.europa.eu/efsajournal
English: Alternative therapies include amoxicillin, erythromycin, tetracyclines and sulphonamides, although resistance which may be plasmid-borne has been reported to aminoglycosides and macrolides in Asia.
Danish: Alternative behandlingsvalg er amoxicillin, erythromycin, tetracykliner og sulfonamider, skønt der i Asien er beskrevet resistens over for aminoglykosider og makrolider, som kan være plasmidmedieret.
English: s.r.o., Murgašova 5, 949 01 Nitra Slovak Republic
Danish: s.r.o., Murgašova 5, 949 01 Nitra Slovakiet
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I), subject to amendments in the product information and conditions on the marketing authorisations; the CVMP has recommended the variations of the marketing authorisations for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I of the opinion) in order to amend the summaries of product characteristics, labelling and package leaflets as set out in annex III.
Danish: • CVMP anså det overordnede benefit/risk-forhold for at være positivt for veterinærlægemidler indeholdende enrofloxacin til administration gennem drikkevandet til kyllinger og/eller kalkuner (se bilag I) under forudsætning af ændringer i produktinformationen og fastsættelse af visse betingelser for markedsføringstilladelserne anbefalede CVMP ændring af markedsføringstilladelserne for veterinærlægemidler indeholdende enrofloxacin til administration gennem drikkevandet til kyllinger og/eller kalkuner (se udtalelsens bilag I) med henblik på ændringer i produktresuméerne, etiketteringen og indlægssedlerne som angivet i bilag III.
English: In vitro susceptibility has been shown in strains of (i) Gram-negative species such as Escherichia coli, Pasteurella multocida and Avibacterium (Haemophilus) paragallinarum and (ii) Mycoplasma gallisepticum and Mycoplasma synoviae.
Danish: Der er påvist in vitro-følsomhed af stammer af i) Gramnegative arter såsom Escherichia coli, Pasteurella multocida og Avibacterium (Haemophilus) paragallinarum samt ii) Mycoplasma gallisepticum og Mycoplasma synoviae (se pkt.
English: Farma vet Ltd. 40 Otec Paisii Str. Shumen 9700
Danish: Bulgarien Farma vet Ltd. 40 Otec Paisii Str.
English: In total, approximately 2000 isolates from broilers, turkeys and layers showed that the overall MIC range was 0.015-≥32 µg/ml, with up to 8.7% resistance.
Danish: Samlet viste ca. 2 000 isolater fra slagtekyllinger, kalkuner og æglæggere MIC-værdier fra 0,015 til ≥32 µg/ml med en resistensandel på op til 8,7 %.
English: Lithuania Ceva Santé Animale, 10 avenue de La Ballastière, 33500 Libourne
Danish: Slovenien Ceva Santé Animale, 10 avenue de La Ballastière, 33500 Libourne
English: Ceva Animal Health Slovakia, spol s r.o., Račianska 77, 831 02 Bratislava, Slovakia
Danish: Ceva Animal Health Slovakia, spol s r.o., Račianska 77, 831 02 Bratislava, Slovakiet
English: Therefore, a warning in Section 4.5 of the Summaries of Products Characteristics (SPCs) that resistance has been identified in M.synoviae in the EU should be added to highlight the risk.
Danish: For at fremhæve risikoen bør der derfor tilføjes en advarsel i produktresuméets punkt 4.5 om, at der er fundet resistens af M.synoviae i EU.
English: Chickens and turkeys (broilers); pigeons not intended for human consumption
Danish: Kyllinger og kalkuner (slagtekyllinger); duer, som ikke er bestemt til konsum
English: 08520 Les Franqueses del Valles, Barcelona Spain
Danish: 08520 Les Franqueses del Valles, Barcelona Spanien
English: Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
Danish: Tyskland Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Tyskland
English: The study did show that one E.coli isolate acquired resistance from the commensal flora of the chicken.
Danish: Derimod erhvervede et isolat af E.coli resistens fra kyllingens kommensale flora.
English: MIC data were provided for enrofloxacin against target pathogens (E.coli, P. multocida, M. gallisepticum, M. synoviae) isolated from respiratory tract infections or septicaemia in poultry.
Danish: Der blev forelagt MIC-data for enrofloxacin over for målpatogener (E.coli, P. multocida, M. gallisepticum, M. synoviae) isoleret fra luftvejsinfektioner eller septikæmi hos fjerkræ.
English: A recent study from Russo et al (2012) used modern techniques of measuring plasma levels after pulsed administration of enrofloxacin in drinking water to turkeys at 10 mg/kg bw.
Danish: I en nylig undersøgelse anvendte Russo et al (2012) moderne teknikker til bestemmelse af plasmakoncentrationerne efter stødvis administration af 10 mg/kg kropsvægt enrofloxacin i drikkevandet til kalkuner.
English: Romania Lavet Pharmaceuticals Ltd., Ottó u. 14.,
Danish: Rumænien Lavet Pharmaceuticals Ltd., Ottó u. 14.,
English: In October 2012, following an Article 34 referral procedure for Baytril 10% Oral Solution (EMEA/V/A/067) the indication for treatment of salmonella infections has been removed from the SPC due to the lack of support for the dosing regimen, especially in regards to elimination of infection, and EU legislation in regards to national control programmes for the control of salmonella in poultry that state that antimicrobials should not be used except in exceptional circumstances (Regulation EC 1177/2006).
Danish: Efter en artikel 34-indbringelsesprocedure for Baytril, oral opløsning, 10 % (EMEA/V/A/067) blev indikationen behandling af infektioner med salmonella i oktober 2012 slettet af produktresuméet på grund af manglende dokumentation af dosisregimet, navnlig til udryddelse af infektion, og EU's lovgivning om nationale kontrolprogrammer for bekæmpelse af salmonella hos fjerkræ, der fastslår, at antimikrobielle stoffer kun må anvendes i ekstraordinære tilfælde (forordning (EF) nr. 1177/2006).
English: A comprehensive PK/PD analysis was provided.
Danish: Der blev forelagt en omfattende farmakokinetisk/farmakodynamisk analyse.
English: This showed that when enrofloxacin is dosed as a single oral dose of 10 mg/kg bw against a less susceptible E.coli isolate with MIC of 0.5 µg/ml, in chickens, AUC/MIC was 28.8 and in turkeys AUC/MIC was 32.2.
Danish: Undersøgelsen viste, at når enrofloxacin gives som en oral enkeltdosis på 10 mg/kg kropsvægt mod et mindre følsomt isolat af E.coli med en MIC på 0,5 µg/ml, var AUC/MIC 28,8 for kyllinger og 32,2 for kalkuner.
English: Ceva Animal Health Slovakia, spol s.r.o., Račianska 77, 831 02 Bratislava, Slovak Republic
Danish: Ceva Animal Health Slovakia, spol s.r.o., Račianska 77, 831 02 Bratislava, Slovakiet
English: Mycoplasma spp are rarely included in surveillance or monitoring schemes and evidence of widespread resistance in the EU or lack of efficacy of the dose in the treatment of mycoplasmosis is hard to find.
Danish: er sjældent omfattet af overvågningsordninger, og det er vanskeligt at finde evidens for udbredt resistens i EU eller manglende virkning af dosis ved behandling af infektion med mycoplasma.
English: 9 GERMAP (2010) Antibiotika-Resistenz und -Verbrauch Bericht über den Antibiotikaverbrauch und die Verbreitung von
Danish: GERMAP (2010) Antibiotika-Resistenz und -Verbrauch Bericht über den Antibiotikaverbrauch und die Verbreitung von Antibiotikaresistenzen in der Human- und Veterinärmedizin in Deutschland.
English: Taking account of the overall data, the indication for the treatment of P.multocida in chickens and turkeys is justified at a dose of 10 mg/kg bw for 3-5 days.
Danish: På grundlag af de samlede data er indikationen behandling af infektion med P.multocida hos kyllinger og kalkuner berettiget ved en dosis på 10 mg/kg kropsvægt i 3-5 dage.
English: Although the data provided are not sufficient to conclusively support the dosing regimen, taking into consideration the fact that colibacillosis is a very common disease in turkeys and the importance of fluoroquinolones in its treatment, it is agreed that the indication and dose regimen should remain in the SPCs of the products concerned.
Danish: Skønt de forelagte data ikke er tilstrækkelige til konklusivt at underbygge dosisregimet, bør indikationen og dosisregimet bibeholdes i produktresuméerne for de pågældende produkter i betragtning af, at coli-infektion er en meget almindelig sygdom hos kalkuner, og at fluorquinoloner er vigtige til at behandle den.
English: Broiler chicken, non-ruminating calves and pigs
Danish: Slagtekyllinger, ikkedrøvtyggende kalve, svin
English: Poultry (chicken)
Danish: Fjerkræ (kyllinger)
English: Germany Eurovet Animal Health BV Handelsweg 25
Danish: Tyskland Eurovet Animal Health BV Handelsweg 25
English: All products are aqueous solutions and contain a solubilising agent, such as potassium hydroxide or acetic acid, a preservative such as benzyl alcohol, and are made up to volume with water; thus there are no indications that formulation differences can account for the variability seen between the studies provided.
Danish: Alle produkter er vandige opløsninger og indeholder et opløselighedsfremmende middel, såsom kaliumhydroxid eller eddikesyre, og et konserveringsstof, såsom benzylalkohol, og er fyldt op til volumen med vand.
English: Belgium Eurovet Animal Health BV Handelsweg 25
Danish: Eurovet Animal Health BV Handelsweg 25
English: Two experimental studies and one field study were submitted to support the indication of Mycoplasma spp in turkeys.
Danish: Der blev forelagt to eksperimentelle undersøgelser og én feltundersøgelse til støtte for indikationen infektion med Mycoplasma spp.
English: 1093 Budapest Hungary
Danish: 1093 Budapest Ungarn
English: Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Danish: Krydsresistens er almindelig i klassen af fluorquinoloner.
English: VIRBAC SA, 13e Rue LID BP 27
Danish: Grækenland VIRBAC SA, 13e Rue LID
English: Blackthorn Road, Dublin 18
Danish: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18
English: However according to the EFSA/ECDC report (2012)5 resistance to ciprofloxacin in indicator E.coli isolates taken from chickens is described as moderate to high at a rate of 47%.
Danish: I EFSA/ECDC's rapport (2012)5 beskrives resistensen over for ciprofloxacin af indikatorisolater af E.coli fra kyllinger imidlertid som moderat til høj med en andel på
English: • Taking into account the decreases in the susceptibility profiles of E. coli observed in EU surveillance from the time enrofloxacin was first authorised in poultry species, a dosing regimen should be elaborated based on new studies that encompass the current susceptibility of E. coli and new PK/PD concepts aimed at limiting the development of resistance for the target pathogens.
Danish: • I betragtning af de fald, der er iagttaget i følsomhedsprofilerne af E. coli i EU's overvågning, siden enrofloxacin først blev godkendt til fjerkræ, bør der opstilles et dosisregime på grundlag af nye undersøgelser, der inddrager den nuværende følsomhed af E. coli, og nye farmakokinetiske/farmakodynamiske koncepter, der sigter mod at begrænse udviklingen i resistens over for målpatogenerne.
English: Romania Laboratorios Syva, s.a.u, Avenue Parroco Pablo Diez
Danish: Rumænien Laboratorios Syva, s.a.u, Avenue Parroco Pablo Diez
English: VET - PARTNERS Ltd. 25 Ivan Asen II Str. 4270 Parvomay Bulgaria
Danish: Bulgarien VET - PARTNERS Ltd. 25 Ivan Asen II Str.
English: Romania Hipra Laboratorios Avda.
Danish: Rumænien Hipra Laboratorios Avda.
English: Target species safety
Danish: Sikkerheden for måldyrearten