FrancophonIA/ELRC3.0 huggingface dataset:
English: These omissions add to the uncertainties that also arise due to the variability in the results of the submitted studies.
Danish: Disse undladelser medvirker til de usikkerheder, der desuden opstår som følge af variabiliteten i resultaterne af de forelagte undersøgelser.
English: Consequently it is concluded that Salmonella as a target pathogen should be removed also from the SPCs of all products concerned by this referral procedure.
Danish: Heraf konkluderes, at Salmonella som målpatogen ligeledes bør slettes af produktresuméerne for alle produkter omfattet af denne indbringelsesprocedure.
English: Control programmes aim to eliminate infection from breeding stock.
Danish: Hensigten med kontrolprogrammer er at udrydde infektionen i avlsflokken.
English: Interchemie Werken De Adelaar BV
Danish: Bulgarien Interchemie Werken De Adelaar BV
English: In this regard, turkeys are recognised as being a minor species.
Danish: I denne sammenhæng anses kalkuner for en mindre betydningsfuld dyreart.
English: Amend where applicable: WITHDRAWAL PERIOD
Danish: Rettes, hvor det er relevant: TILBAGEHOLDELSESTID
English: The conditions of the Marketing Authorisations are described in annex IV.
Danish: Betingelserne for markedsføringstilladelserne fremgår af bilag IV.
English: The CVMP's conclusion on the benefit-risk balance will be revisited in line with the provisions in these conditions.
Danish: CVMP's konklusion om benefit/risk-forholdet vil blive underkastet en ny vurdering i overensstemmelse med bestemmelserne i disse betingelser.
English: The data submitted demonstrate that the Salmonella control programmes implemented over the last 20 years have reduced the prevalence of non-typhoidal Salmonella in poultry.
Danish: De forelagte data viser, at de Salmonella-kontrolprogrammer, der er indført i de seneste 20 år, har nedsat prævalensen af ikke-tyfoide Salmonella i fjerkræ.
English: Can Parellada Industrial 08228 Tarrassa Spain
Danish: Can Parellada Industrial 08228 Tarrassa Spanien
English: Novo mesto, Šmarjeska cesta 6 8501 Novo Mesto Slovenia
Danish: Novo mesto, Šmarjeska cesta 6 8501 Novo Mesto Slovenien
English: Not authorised for use in birds producing eggs for human consumption.
Danish: Ikke til anvendelse hos fugle, der producerer æg til menneskeføde.
English: Romania Pasteur - Filiala Filipesti SRL Str. Principala nr. 944
Danish: Rumænien Pasteur - Filiala Filipesti SRL Str. Principala nr. 944
English: The data were too variable to be analysed in this way because the studies were not sufficiently similar and the influence of some aspects of study design could not be taken into account when interpreting the findings.
Danish: Dataene var for variable til at kunne analyseres på denne måde, fordi undersøgelserne ikke var tilstrækkeligt ensartede, og visse aspekter af forsøgsdesign ikke kunne tages i betragtning ved fortolkning af resultaterne.
English: In addition, P.multocida causes acute, serious and highly contagious disease in poultry, therefore there is a justification for having a second line treatment available for this pathogen.
Danish: Desuden medfører P.multocida akut, alvorlig og stærkt smitsom sygdom hos fjerkræ, hvilket giver grund til at have rådighed over en andetvalgsbehandling mod denne patogen.
English: The studies were mainly conducted between 1985 and 1998 and did not conclusively show optimum efficacy with a dose rate of 10 mg/kg bw.
Danish: Undersøgelserne blev hovedsagelig udført mellem 1985 og 1998 og viste ikke konklusivt optimal virkning ved en dosering på 10 mg/kg kropsvægt.
English: Mazā Rāmavas 2, Valdlauči, Ķekavas novads, Latvia
Danish: Mazā Rāmavas 2, Valdlauči, Ķekavas novads, Letland
English: The evaluation of data generated in fulfilment of these conditions should be undertaken by CVMP in the interests of maintaining the harmonised EU approach achieved by this referral procedure, and given the EU-wide importance of achieving an optimal dose regimen for this range of products.
Danish: Data, der genereres til opfyldelse af disse betingelser, skal vurderes af CVMP for at videreføre den harmoniserede EU-tilgang ved denne indbringelsesprocedure og på baggrund af vigtigheden af at fastlægge et optimalt dosisregime for denne række produkter i hele EU.
English: P+P Kereskedőház 1046 Budapest, Hungary
Danish: P+P Kereskedőház 1046 Budapest, Ungarn
English: Romania DELOS IMPEX' 96 SRL Str. Horia, Cloşca şi Crişan, nr. 81, Otopeni, Jud.
Danish: Rumænien DELOS IMPEX' 96 SRL Str. Horia, Cloşca şi Crişan, nr. 81, Otopeni, Jud.
English: The data presented show that the MICs of E.coli have increased over the last 20 years and the approved dose regimen may no longer be optimal.
Danish: De forelagte data viser, at MIC-værdierne for E.coli er steget gennem de seneste tyve år, og at den godkendte dosering muligvis ikke længere er optimal.
English: 7100 Szekszárd, Hungary
Danish: 7100 Szekszárd, Ungarn
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsveje og ansøgere/indehavere af markedsføringstilladelse i medlemsstaterne
English: There has been much debate as to whether quinolone resistant Campylobacter infection is associated with adverse human health consequences.
Danish: Der har været megen debat om, hvorvidt infektion med quinolonresistente Campylobacter er forbundet med negative sundhedsvirkninger for mennesker.
English: Eleven references were submitted, two of which were dated after 2000, in support of the indication for Mycoplasma spp.
Danish: Der blev forelagt 11 referencer, hvoraf to var dateret efter 2000, til støtte for indikationen Mycoplasma spp.
English: Following a referral procedure (EMEA/V/A/067) under Article 34 of Directive 2001/82/EC, the full product information of the ‘pioneer' product ‘Baytril 10% Oral Solution' and it associated names was harmonised with a Commission Decision of 8 October 20121.
Danish: Efter en indbringelsesprocedure (EMEA/V/A/067) i medfør af artikel 34 i direktiv 2001/82/EF blev hele produktinformationen for “foregangsproduktet” “Baytril, oral opløsning, 10 % ”, og relaterede navne, harmoniseret ved en kommissionsbeslutning af 8. oktober 20121.
English: In a study from 2010 an experimental infection of E.coli did not acquire resistance from a preinoculated multi-resistant E.coli.
Danish: I en undersøgelse fra 2010 erhvervede en eksperimentel infektion med E.coli ikke resistens fra en præinokuleret multiresistent E.coli.
English: These data provide information regarding the possible implications of a change of dose regimen on target species safety.
Danish: Disse data giver viden om de mulige følger af et ændret dosisregime for måldyreartens sikkerhed.
English: The variability of the data leads to estimates of the withdrawal period for chickens ranging between 4 and 8 days and between 4 and 13 days for turkeys, depending on the individual study.
Danish: Variabiliteten af dataene fører til en beregnet tilbageholdelsestid for kyllinger på mellem 4 og 8 dage og for kalkuner mellem 4 og 13 dage, alt efter de enkelte undersøgelser.
English: • Size and weight of the birds used in the studies varied considerably, and did not correlate to the calculated length of the WP from each study;
Danish: • Størrelsen og vægten af de i undersøgelserne anvendte fugle, der varierede betydeligt og stemte ikke overens med den beregnede tilbageholdelsestid for hver undersøgelse.
English: In the strains that were isolated, resistance to ciprofloxacin was absent.
Danish: I de stammer, der blev isoleret, var der ingen resistens over for ciprofloxacin.
English: Other MAHs however, did supply these data, and as such, the studies provided by these companies provide more reliable information on which to base a conclusion on the length of the meat withdrawal periods.
Danish: Andre markedsføringstilladelsesindehavere leverede imidlertid disse data, og undersøgelserne fra disse virksomheder giver derfor et mere pålideligt grundlag for en konklusion om tilbageholdelsestider for kød.
English: Although both studies had been conducted approximately 25 years ago, there are sufficient data to support the indication for A.paragallinarium at the proposed dose rate.
Danish: Skønt begge undersøgelser blev udført for ca. 25 år siden, er der tilstrækkelige data til at støtte indikationen infektion med A.paragallinarium ved den foreslåede dosering.
English: Szkolna 17, 63-100 Śrem Poland
Danish: Szkolna 17, 63-100 Śrem Polen
English: Lithuania PPHU "INEX" Partnership, ul.
Danish: PPHU "INEX" Partnership, ul.
English: • Correction factors based on the determined accuracy of the analytical method have been used in some cases and not in others;
Danish: • I nogle tilfælde er anvendt korrektionsfaktorer for den beregnede nøjagtighed af analysemetoderne, i andre ikke.
English: INTERSIGN Pechačkova 5, 150 00 Prague 5 Czech Republic
Danish: INTERSIGN Pechačkova 5, 150 00 Prague 5 Tjekkiet
English: Toutain, 200612, advises that the optimal dosage regimen for antibiotics should be a “population dosage regimen” aimed to ensure appropriate exposure of most (90%) of the animals in a given population and, as far as possible, limit the under-exposure of some individuals to the drug and hence limit the risk of emergence of resistance.
Danish: Toutain, 200612, anbefaler et “populationsdosisregime” som det optimale dosisregime for antibiotika, dvs. et regime, der sikrer tilstrækkelig eksponering af størstedelen (90 %) af individerne og så vidt muligt begrænser undereksponeringen af nogle individer for lægemidlet og dermed risikoen for udvikling af resistens.
English: Add, to all products and delete the existing text:
Danish: For alle produkter indsættes følgende, og den eksisterende tekst slettes:
English: Do not use when resistance/ cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment.
Danish: Må ikke anvendes ved forekomst af resistens/krydsresistens over for (fluor)quinoloner i den flok, der påtænkes behandlet.
English: In order to recommend a dosage regimen, the population variability and the impact of disease on pharmacokinetic parameters needed to be investigated.
Danish: For at der kan anbefales et dosisregime, skal populationens variabilitet og sygdommens indvirkning på de farmakokinetiske parametre være undersøgt.
English: Although the studies provided are not considered to be of equal reliability, the CVMP attempted a ‘pooled' statistical analysis of all the data provided by all of the studies submitted and found that this method could not be applied, because the statistical parameters (defined by the Bartlett, Shapiro-Wilk and ANOVA (lack of fit) tests) showed a significant deviation from normality (p < 0.01), i.e. the data were not normally distributed and showed no homogeneity of variance.
Danish: Skønt de forelagte undersøgelser ikke alle anses for lige pålidelige, forsøgte CVMP at foretage en “poolet” statistisk analyse af alle data fra alle undersøgelserne, men konstaterede, at denne metode ikke kunne anvendes, da de statistiske parametre (defineret ved Bartlett-, Shapiro-Wilk- og ANOVAtest (manglende lighed)) viste væsentlig afvigelse fra normalitet (p < 0,01), dvs. dataene var ikke normalfordelt og udviste ikke homogen varians.
English: The recommendations were carried forward to the CVMP Strategy 2011-2015 and were addressed in the previous Article 35 referral for all veterinary medicinal products for food producing species containing quinolones and/or fluoroquinolones as active substances (EMEA/V/A/049)19 and in the current referral.
Danish: Disse anbefalinger blev overført til CVMP's strategi for 2011-2015 og anvendt i den foregående artikel 35-indbringelse vedrørende alle veterinærlægemidler, der er bestemt til fødevareproducerende arter, og som indeholder quinoloner og/eller fluorquinoloner som aktivt stof (EMEA/V/A/049)19, samt i nærværende indbringelse.
English: Clinical response is also affected by pharmacodynamic variability (host response, population distribution of MIC values for the target pathogen).
Danish: Den kliniske respons påvirkes desuden af den farmakodynamiske variabilitet (værtsrespons, fordeling i populationen af MIC-værdier for målpatogenet).
English: These showed that there is a gradual increase in MIC and resistance over the last 10 years.
Danish: Disse viste, at MIC-værdier og resistens er steget gradvis gennem de seneste 10 år.
English: All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Danish: Alle disse mekanismer medfører nedsat følsomhed af bakterierne over for fluorquinoloner.
English: Under field conditions, Mycoplasma is typically part of a mixed infection, therefore it can be difficult to demonstrate field efficacy for this indication.
Danish: Under feltbetingelser indgår Mycoplasma typisk i en blandet infektion, hvorfor det kan være vanskeligt at påvise virkning ved denne indikation i felten.
English: Tarragona Spain
Danish: Tarragona Spanien
English: It has to be borne in mind that this resistance rate is based on epidemiological cut-off values
Danish: Man må være opmærksom på, at denne resistensandel er baseret på epidemiologiske afskæringsværdier for ikke-patogene stammer.
English: Its bactericidal activity inhibits the bacterial DNA-gyrase.
Danish: Dets baktericide aktivitet medieres gennem den bakterielle DNA-gyrase.
English: Once infected, birds may remain carriers, and although antibiotics may alleviate clinical signs and lesions, they do not eliminate infection.
Danish: Når fuglene først er smittet, forbliver de bærere, og skønt antibiotika kan mindske de kliniske tegn og forandringer, udrydder de ikke infektionen.
English: Quantitative histopathological evaluation revealed no substantial changes in examined articular cartilages in birds treated with doses up to 100 mg/kg bw/day.
Danish: Kvantitativ histopatologisk vurdering viste ingen væsentlige ændringer i den undersøgte ledbrusk hos fugle behandlet med doser op til 100 mg/kg kropsvægt/dag.
English: The majority of studies used an experimental inoculation with M.gallisepticum.
Danish: I størstedelen af undersøgelserne var der anvendt eksperimentel inokulering med M.gallisepticum.
English: Romania S.C.MARAVET SRL 9 Europa,
Danish: Rumænien S.C.MARAVET SRL 9 Europa,
English: 28031 Madrid Spain
Danish: 28031 Madrid Spanien
English: • The marketing authorisation holders should also provide scientific justification/s that this new dosing regimen will be effective for the treatment of the remaining target pathogens in the SPC.
Danish: • Indehaverne af markedsføringstilladelse skal desuden fremlægge videnskabelig begrundelse for, at dette nye dosisregime vil være effektivt til behandling af infektioner med de øvrige målpatogener i produktresuméet.
English: Aerden L V.M.D Hoge Mauw 900 2370 Arendonk Belgium
Danish: Aerden L V.M.D Hoge Mauw 900 2370 Arendonk Belgien
English: For example, approximately 25-35% of enrofloxacin, at any given timepoint, is metabolized to ciprofloxcacin, resulting in subtherapeutic concentrations of ciprofloxacin, that could select for resistant strains, as well as cross-resistance.
Danish: F.eks. vil 25-35 % af enrofloxacin til hver en tid være metaboliseret til ciprofloxacin, hvilket resulterer i subterapeutiske koncentrationer af ciprofloxacin, som både kan medføre selektion af resistente stammer og krydsresistens.
English: Isolates were from cases of respiratory tract infections or septicaemia of poultry.
Danish: Isolaterne stammede fra tilfælde af luftvejsinfektioner eller septikæmi hos fjerkræ.
English: Romvac Co.S.A, 7 Soseaua Centurii, Voluntari, IF-077190 Romania
Danish: Romvac Co.S.A, 7 Soseaua Centurii, Voluntari, IF-077190 Rumænien
English: It has been shown that both MICs and resistance are increasing within the EU.
Danish: Både MIC-værdier og resistens er påvist at være tiltagende i EU.
English: The Committee agreed that the most conservative withdrawal periods, derived from the better conducted and reported studies, should be established i.e. 7 days for chickens and 13 days for turkeys.
Danish: I udvalget var der enighed om at fastsætte de mest forsigtige tilbageholdelsestider, der kunne udledes af de bedst udførte og beskrevne undersøgelser, altså 7 dage for kyllinger og 13 dage for kalkuner.
English: If the withdrawal period for turkeys is extrapolated from residues studies in chickens, then an additional safety factor should be added to take into account the evidence from previous residues studies that demonstrated that the depletion of enrofloxacin is slower in turkeys than chickens.
Danish: Hvis tilbageholdelsestiden for kalkuner er ekstrapoleret fra restkoncentrationsundersøgelser hos kyllinger, skal der anvendes en ekstra sikkerhedsfaktor, der tager de tidligere restkoncentrationsundersøgelser i betragtning, som viste, at depletionen af enrofloxacin er langsommere hos kalkuner end hos kyllinger.
English: Vétoquinol s.r.o., Zámečnická 411, 288 02 Nymburk Czech Republic
Danish: Vétoquinol s.r.o., Zámečnická 411, 288 02 Nymburk Tjekkiet
English: The susceptibility of E.coli isolated predominantly from Germany as part of the GermVet 20087 and 20098 and Germap 20109 resistance monitoring during 2004-2009 was provided.
Danish: Der blev oplyst følsomhed af E.coli hovedsagelig isoleret i Tyskland som led i resistensovervågningen GermVet 20087 og 20098 og Germap 20109 for perioden 2004-2009.
English: The United Kingdom also noted that the withdrawal periods for oral solutions containing enrofloxacin vary across Member States from 3-15 days for chickens and 3-13 days for turkeys, therefore on 18 October 2012, the United Kingdom presented to the European Medicines Agency a referral notification under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys.
Danish: Det Forenede Kongerige bemærkede endvidere, at tilbageholdelsestiderne for orale opløsninger indeholdende enrofloxacin i medlemsstaterne varierer fra 3 til 15 dage for kyllinger og fra 3 til 13 dage for kalkuner, og anmeldte derfor den 18. oktober 2012 til Det Europæiske Lægemiddelagentur en indbringelse i medfør af artikel 35 i direktiv 2001/82/EF for alle veterinærlægemidler indeholdende enrofloxacin til administration gennem drikkevandet til kyllinger og/eller kalkuner.
English: In addition, PK/PD concepts have recently been developed that use the hypothesis of the mutant selection window in order to elaborate a dosing regimen that can limit the emergence of resistant organisms (Drlica & Zhao, 2007)13.
Danish: Desuden er der nylig blevet udviklet farmakokinetiske/farmakodynamiske koncepter, ved hvilke der på grundlag af hypotesen om selektionsvinduet for mutationer fastlægges et dosisregime, der kan begrænse udviklingen af resistente organismer (Drlica & Zhao, 2007)13.
English: During the above mentioned Article 34 referral procedure for Baytril 10% oral solution and its associated names it became apparent that some of the indications for use in the target species chickens and turkeys were not consistent with the principles of responsible use of antimicrobial veterinary medicinal products and therefore such indications were removed from the harmonised product information.
Danish: Under den nævnte artikel 34-procedure for Baytril, oral opløsning, 10 %, og relaterede navne fremgik det, at nogle af indikationerne for anvendelse hos måldyrearterne kyllinger og kalkuner ikke fulgte principperne for ansvarlig anvendelse af antimikrobielle veterinærlægemidler, hvorfor de pågældende indikationer blev slettet i den harmoniserede produktinformation.
English: agreed with these conclusions, although the MIC90 remained low at 0.03 µg/ml, range 0.008 -2 µg/ml (Wallman et al, 2007)3.
Danish: udført i EU, var i overensstemmelse med disse konklusioner, skønt MIC90 forblev lav på 0,03 µg/ml med variationsbredde 0,008-2 µg/ml (Wallman et al, 2007)3.
English: A further warning in section 4.4 of the SPCs should be added also to advise that treatment of mycoplasma infections may not eradicate the organism.
Danish: I produktresuméets punkt 4.4 bør der tilføjes endnu en advarsel om, at behandling af infektioner med Mycoplasma ikke nødvendigvis udrydder organismen.
English: Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms.
Danish: Behandling i 3-5 på hinanden følgende dage; behandling i 5 på hinanden følgende dage ved blandede infektioner eller kronisk fremadskridende tilfælde.
English: They show that 10 mg/kg bw enrofloxacin was efficacious in reducing mortality and morbidity and that there was reduction in pathogen re-isolation for up to 4 weeks after inoculation.
Danish: De viser, at 10 mg/kg kropsvægt enrofloxacin var effektivt til at nedsætte mortalitet og morbiditet, og at reisolation af patogener var reduceret i op til fire uger efter inokulering.
English: 22603 Loudeac Cedex France
Danish: 22603 Loudeac Cedex Frankrig
English: • The method of administration; some studies used gavage administration (which improves the accuracy of the dose, but also (potentially) affects the metabolic profile of the substance, since this is in effect a bolus dose, rather than a continuous dose), some studies used drinking water administration, as specified in the SPCs (which could lead to more variable results due to some birds drinking more medicated water than others, but is more representative of what would happen ‘in the field');
Danish: • Administrationsmetoden: I nogle undersøgelser anvendtes gavage (som forbedrer doseringsnøjagtigheden, men også (potentielt) påvirker stoffets metaboliske profil, da der reelt er tale om en bolus og ikke-kontinuerlig dosering), og i andre undersøgelser anvendtes administration i drikkevandet som foreskrevet i produktresuméerne (hvilket kan give mere varierende resultater, fordi nogle fugle drikker mere medicineret vand end andre, men er mere repræsentativt for feltbetingelser).
English: Do not administer to layer replacement birds within 14 days of coming into lay.
Danish: Må ikke administreres til erstatningsfugle for æglæggere mindre end 14 dage inden æglægning.
English: Reduced susceptibility has been detected (11.349.4%) for years, based on a breakpoint of ≥4 µg/ml and a non-wild type MIC of ≥0.12 µg/ml.
Danish: Der er i årevis blevet konstateret nedsat følsomhed (11,3-49,4 %) ved et breakpoint på ≥4 µg/ml og en MIC for ikke-vildtype på ≥0,12 µg/ml.
English: • A new overall benefit-risk should be provided for the products for the treatment of respiratory disease in chickens and turkeys.
Danish: • Der skal forelægges en ny overordnet vurdering af benefit/risk-forholdet for produkterne til behandling af luftvejssygdom hos kyllinger og kalkuner.
English: One study also demonstrated that continuous administration of the product at 10 mg/kg bw was better than pulsed
Danish: Én undersøgelse viste desuden, at kontinuerlig administration af produktet i en dosis på 10 mg/kg kropsvægt var bedre end
English: In addition the CVMP concluded that there is insufficient data to optimise the dose regimen for treatment of Escherichia coli in chickens and/or turkeys.
Danish: Desuden konkluderede Udvalget for Veterinærlægemidler (CVMP), at der ikke er tilstrækkelige data til at optimere dosisregimet for behandling af Escherichia coli hos kyllinger og/eller kalkuner.
English: The data do not conclusively justify the proposed dose rate against the named mycoplasma species.
Danish: Dataene kan ikke konklusivt begrunde den foreslåede dosering ved infektion med nævnte Mycoplasma-arter.
English: HIPRALONA ENROS
Danish: HIPRALONA ENRO-S
English: Grójecka 6, 05-651 Drwalew, Poland
Danish: Grójecka 6, 05-651 Drwalew, Polen
English: The method of antimicrobial administration via the drinking water increases the resistance selection pressure due to variability in intake and therefore pharmacokinetics across the population.
Danish: Administration af antimikrobielle stoffer i drikkevandet øger selektionstrykket til fordel for resistens som følge af variabiliteten af indtaget og dermed af de farmakokinetiske forhold i populationen.
English: Gliniana 32, 20-616 Lublin, Poland
Danish: Gliniana 32, 20-616 Lublin, Polen