FrancophonIA/ELRC3.0 huggingface dataset:
English: Since then it has spread to cattle worldwide and is known to cause severe economic losses in the herds affected.
Danish: Siden da har den bredt sig til kvæg over hele verden og er kendt for at medføre svære økonomiske tab i de berørte besætninger.
English: Affected milk may seem normal but it may also be purulent and/or have abnormal and discoloured secretions.
Danish: Den berørte mælk kan se normal ud, men kan også være purulent og/eller indeholde unormalt eller misfarvet sekret.
English: A negative cultivation result after treatment could, before, have been falsely interpreted as bacteriological cure although at present it is known merely to be a characteristic of the infection.
Danish: Et negativt dyrkningsresultat efter behandlingen kan tidligere være blevet fejlfortolket som bakteriologisk helbredelse, skønt det i dag vides blot at være et kendetegn ved infektionen.
English: The Committee concluded that indications for use should preferably be restricted to those for which efficacy has been proven and general indications without a solid clinical basis should be avoided.
Danish: Udvalget konkluderede, at indikationerne fortrinsvis bør begrænses til dem, der er påvist virkning for, og at generelle indikationer uden solidt klinisk grundlag bør undgås.
English: (see Annex I)
Danish: (se bilag I)
English: These veterinary medicinal products are also indicated for the treatment of several other diseases including respiratory and gastrointestinal infections, but these indications fall outside the scope of this referral procedure.
Danish: Disse veterinærlægemidler er desuden indiceret til behandling af flere andre sygdomme, herunder respiratoriske og gastrointestinale infektioner, men disse indikationer falder uden for denne indbringelsesprocedure.
English: (see Annex I) in order to amend the summary of product characteristics, labelling and package leaflet in line with recommended changes in the product information as set out in Annex III.
Danish: (se bilag I) med henblik på at ændre produktresuméet, etiketteringen og indlægssedlen i overensstemmelse med de anbefalede ændringer i produktinformationen som angivet i bilag III.
English: In 1977 Jasper 2 described natural resolution of the disease as unpredictable and recognised the danger of intermittently shedding cows.
Danish: I 1977 beskrev Jasper2 den naturlige forsvinden af sygdommen som uforudsigelig og nævnte faren ved, at køer udskiller intermitterende.
English: based solely on the pharmacovigilance data as it is highly likely that such adverse events for antimicrobials are very seldom reported.
Danish: udelukkende på grundlag af lægemiddelovervågningsdata, da sådanne uønskede virkninger af antimikrobielle stoffer højst sandsynligt meget sjældent indberettes.
English: He reported testing various antimicrobials, including tylosin.
Danish: Han beskrev afprøvning af forskellige antimikrobielle stoffer, herunder tylosin.
English: Instead several comprehensive review articles dealing with mycoplasma mastitis have been published (Pfützner and Sachse (1996)4, Nicholas and Ayling (2003)5, Gonzalez and Wilson (2003)6, Maunsell et al. (2011)7, Fox (2012)8, Nicholas et al. (2016)9).
Danish: I stedet er der offentliggjort flere omfattende oversigtsartikler om mycoplasma-mastitis (Pfützner og Sachse (1996)4, Nicholas og Ayling (2003)5, Gonzalez og Wilson (2003)6, Maunsell et al. (2011)7, Fox (2012)8, Nicholas et al. (2016)9).
English: It is a major problem for milk production and animal welfare in the herds affected, and causes severe economic losses.
Danish: Den er et stort problem for mælkeproduktionen og dyrevelfærden i de angrebne besætninger og medfører svære økonomiske tab.
English: It is active mostly against Gram-positive bacteria and mycoplasmas.
Danish: Det er aktivt hovedsagelig mod grampositive bakterier og Mycoplasma.
English: Mycoplasmas do not grow on conventional media; this hampers the diagnosis.
Danish: Mycoplasma vokser ikke på almindelige dyrkningsmedier, hvilket vanskeliggør diagnosen.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration and applicants/marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, dyrearter, indgivelsesvej og ansøgere/indehavere af markedsføringstilladelse i medlemsstaterne
English: The major pathogen among the genera is Mycoplasma bovis that was first isolated from bovine mastitis in the USA in the 1960s.
Danish: Den vigtigste af de patogene arter er Mycoplasma bovis, der første gang blev isoleret fra bovin mastitis i USA i 1960'erne.
English: Internationally agreed methodology on sensitivity testing was not available at the time when tylosin was first authorised for veterinary use and there is none to date.
Danish: Der fandtes ikke internationalt anerkendte metoder til følsomhedsbestemmelse, da tylosin første gang blev godkendt til veterinær anvendelse, og der er ikke hidtil fremkommet nogen.
English: The pathogen is highly contagious and causes severe economic losses.
Danish: Den patogene organisme er stærkt smitsom og er årsag til svære økonomiske tab.
English: In the study by Biddle et al., 20033, milk samples were collected daily for 28 days from 10 Mycoplasma spp.
Danish: I undersøgelsen foretaget af Biddle et al., 20033 blev der indsamlet mælkeprøver dagligt i 28 dage fra 10 malkekøer smittet med Mycoplasma spp.
English: The marketing authorisation holder for the reference medicinal product ‘Tylan 200 mg/ml', Elanco Animal Health, agreed with the concerns raised and concluded that there is a lack of reliable pre-clinical and clinical data in support of the respective indication.
Danish: Indehaveren af markedsføringstilladelsen for referencelægemidlet "Tylan 200 mg/ml", Elanco Animal Health, tilsluttede sig de rejste betænkeligheder og konkluderede, at der savnes pålidelige prækliniske og kliniske data til støtte for den pågældende indikation.
English: Jasper was also one of the first to question the efficacy of antimicrobials in the treatment of mycoplasma mastitis.
Danish: Jasper var også blandt de første, der rejste tvivl om virkningen af antimikrobielle stoffer til behandling af mycoplasma-mastitis.
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms.
Danish: Tylosin og dets fosfat- og tartratsalt anvendes i veterinærlægemidler til behandling af sygdomme forårsaget af tylosinfølsomme organismer.
English: In addition to the spread to other quarters, hematologic dissemination of mycoplasma to other parts of the body, e.g. joints, respiratory tract and ears, is possible.
Danish: Ud over spredning til andre kirtler er der mulighed for hæmatogen spredning af Mycoplasma til andre dele af kroppen, fx led, respirationsveje og ører.
English: Tylosin belongs to macrolides which have been classified as critically important antimicrobials both in veterinary and human medicine.
Danish: Tylosin tilhører makroliderne, der er klassificeret som kritisk vigtige antimikrobielle stoffer både i veterinær-og humanmedicinen.
English: Macrolides are categorised as critically important antimicrobials both in human and veterinary medicine however tylosin is not used in human medicine.
Danish: Makrolider er kategoriseret som kritisk vigtige antimikrobielle stoffer i både human- og veterinærmedicinen, dog anvendes tylosin ikke i humanmedicinen.
English: M. bovis is a highly contagious udder pathogen that is easily spread.
Danish: M. bovis er en stærkt smitsom yverpatogen, der let spredes.
English: The use of tylosin as a veterinary medicine has been discussed in the CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009)1.
Danish: Tylosins rolle som veterinærlægemiddel diskuteres i CVMP's oplæg om anvendelse af makrolider, lincosamider og streptograminer (MLS) hos fødevareproducerende dyr i EU: "development of resistance and impact on human and animal health" (resistensudvikling og virkningen heraf på menneskers og dyrs sundhed) (EMA/CVMP/SAGAM/741087/2009)1.
English: or ‘bovine mastitis caused by Mycoplasma bovis' are deleted from the indication of parenteral tylosin products, the Committee considered that the benefit-risk of these products could continue to be regarded as positive.
Danish: eller "bovin mastitis forårsaget af Mycoplasma bovis" slettes fra indikationen for parenterale tylosin-produkter, fandt udvalget, at benefit/risk-forholdet for disse produkter fortsat kunne anses for at være positivt.
English: causes respiratory infections, arthritis and otitis (media) both in young and old cattle.
Danish: årsag til luftvejsinfektioner, arthritis og otitis (media) hos både ungkvæg og gammelt kvæg.
English: As the aforementioned indications have been included in the product information of these veterinary medicinal products for many years, the Committee considered that information on the removal of the indication should be given, thus the following warning sentence should be added to the product information: ‘The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.
Danish: Da de nævnte indikationer har været indeholdt i produktinformationen for disse veterinærmedicinske produkter i mange år, fandt udvalget, at der bør gives oplysning om sletningen af indikationen ved tilføjelse af følgende advarsel i produktinformationen: "Dataene om virkning underbygger ikke anvendelsen af tylosin til behandling af bovin mastitis forårsaget af Mycoplasma spp."
English: Despite the improved diagnostic technologies, a major challenge in the diagnosis of mycoplasma mastitis (and in assessing success of antimicrobial treatment) remains that the pathogen may be shed intermittently in the milk of infected cows.
Danish: Trods den forbedrede diagnostiske teknik er det fortsat en stor udfordring ved diagnosen af mycoplasma-mastitis (og ved vurdering af virkningen af den antimikrobielle behandling), at den patogene organisme kan udskilles intermitterende i mælk fra inficerede køer.
English: 1 CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf
Danish: 1 CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf indikationerne gennemgås og revideres på grundlag af den nuværende videnskabelige viden, hvor det er hensigtsmæssigt.
English: Cattle Pigs Dogs
Danish: Kvæg Svin Hunde
English: causes a variety of infections including respiratory disease, otitis media, arthritis and mastitis in cattle worldwide.
Danish: er årsag til en række infektioner, herunder luftvejssygdom, otitis media, arthritis og mastitis, hos kvæg verden over.
English: The common view shared in these reviews is that mycoplasma mastitis is untreatable or unresponsive to antimicrobial treatment and that quick identification of infected animals is crucial to prevent the spread of the pathogen in the herd.
Danish: Det fælles synspunkt i disse oversigtsartikler er, at mycoplasma-mastitis ikke kan behandles eller ikke responderer på antimikrobiel behandling, og at hurtig identifikation af smittede dyr er afgørende for at forhindre spredning af den patogene organisme i besætningen.
English: or ‘bovine mastitis caused by Mycoplasma bovis' should be deleted from the product information for veterinary medicinal products containing tylosin that are administered parenterally.
Danish: eller "bovin mastitis forårsaget af Mycoplasma bovis" bør slettes fra produktinformationen for veterinærmedicinske produkter, der indeholder tylosin og administreres parenteralt.
English: 4.2 Indication(s) for use
Danish: 4.2 Indikation(er)
English: However, it is difficult, if not impossible, to assess the true level of lack of efficacy of tylosin in the treatment of ‘bovine mastitis caused by Mycoplasma spp.'
Danish: Det er imidlertid vanskeligt, om ikke umuligt, at vurdere den egentlige grad af manglende virkning af tylosin til behandling af "bovin mastitis forårsaget af Mycoplasma spp."
English: Therefore, on 22 June 2016, Finland initiated a referral procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Danish: Finland indledte derfor den 22. juni 2016 en indbringelsesprocedure i medfør af artikel 35 i direktiv 2001/82/EF for veterinærlægemidler, der indeholder tylosin, administreres parenteralt og er bestemt til behandling af bovin mastitis forårsaget af Mycoplasma spp.
English: or ‘bovine mastitis caused by Mycoplasma bovis' can no longer be maintained;
Danish: og "bovin mastitis forårsaget af Mycoplasma bovis" ikke længere kan opretholdes,
English: A thorough literature search to find new data on the efficacy of tylosin in the treatment of mycoplasma mastitis revealed no original studies.
Danish: En grundig litteratursøgning efter nye data om virkningen af tylosin til behandling af mycoplasmamastitis resulterede ikke i nogen originale undersøgelser.
English: The authors concluded that the risk of misdiagnosis is increased if multiple milk samples are not tested.
Danish: Forfatterne konkluderede, at risikoen for fejl øges, hvis der ikke
English: Route of administration
Danish: Dyrearter Administrationsvej
English: Mastitis caused by M. bovis differs in several ways from infections caused by the majority of the more common mastitis pathogens (e.g. Streptococcus spp., Staphylococcus spp.).
Danish: Mastitis forårsaget af M. bovis afviger på flere måder fra infektioner forårsaget af størstedelen af de mere almindelige mastitis-patogener (fx Streptococcus spp.
English: • in the absence of pre-clinical or clinical data and in light of the current scientific knowledge the CVMP considered that the treatment of bovine mastitis caused by Mycoplasma spp.
Danish: • i fravær af prækliniske og kliniske data og på baggrund af den nuværende videnskabelige viden fandt CVMP, at behandling af bovin mastitis forårsaget af Mycoplasma spp.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to consider the available data and the current scientific knowledge, and to provide its opinion on whether the indication 'bovine mastitis caused by Mycoplasma spp.'
Danish: Udvalget for Lægemidler til Dyr (CVMP) blev anmodet om at gennemgå de foreliggende data og den nuværende videnskabelige viden og fremsætte en udtalelse om, hvorvidt indikationen "bovin mastitis forårsaget af Mycoplasma spp."
English: with veterinary medicinal products containing tylosin that are administered parenterally is not effective;
Danish: med veterinærlægemidler indeholdende tylosin, der administreres parenteralt, ikke er effektiv,
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Danish: Videnskabelige konklusioner og begrundelser for ændringen af produktresuméet, etiketteringen og indlægssedlen
English: In cases where the indication for a particular product specifies the mastitis pathogen as Mycoplasma bovis, the indication should also be deleted.
Danish: I tilfælde, hvor indikationen for et bestemt produkt specificerer den mastitis-forårsagende patogene organisme som Mycoplasma bovis, skal indikationen ligeledes slettes.
English: with veterinary medicinal products containing tylosin that are administered parenterally is not effective.
Danish: med veterinærmedicinske produkter indeholdende tylosin, der administreres parenteralt, ikke er effektiv.
English: Finland noted that in the current scientific literature there is no support for the indication 'bovine mastitis caused by Mycoplasma bovis', but instead it is widely stated that there are no antimicrobial treatment options for bovine mastitis caused by mycoplasma.
Danish: Finland bemærkede, at indikationen "bovin mastitis forårsaget af Mycoplasma bovis" ikke understøttes i den nuværende videnskabelige litteratur, men at den generelle opfattelse er, at der ikke findes antimikrobielle behandlingsmuligheder for bovin mastitis forårsaget af Mycoplasma.
English: M. bovis is a highly contagious udder pathogen which typically causes mastitis that affects several quarters as it is capable of hematologic dissemination.
Danish: M. bovis er en stærkt smitsom yverpatogen, der typisk medfører mastitis i flere kirtler, da den kan sprede sig hæmatogent.
English: It is generally accepted that all use of antimicrobials increases the risk of antimicrobial resistance and thus to minimise the risk of transmission of those resistance to the public and animals all unnecessary use should be carefully avoided.
Danish: For at minimere risikoen for overførsel af resistens til offentligheden og til dyr bør al unødvendig anvendelse derfor omhyggeligt undgås.
English: In cases where the indication for a particular product specifies the mastitis pathogen as Mycoplasma bovis, the dosing instruction should also be deleted.
Danish: I tilfælde, hvor indikationen for et bestemt produkt specificerer den mastitisforårsagende patogene organisme som Mycoplasma bovis, skal doseringsanvisningen ligeledes slettes.
English: from the bovine mastitis indications for the concerned tylosin injectable products in the European Union.
Danish: slettes fra indikationerne vedrørende bovin mastitis for de pågældende tylosininjektionspræparater i EU.
English: United Kingdom Vetoquinol UK Ltd Vetoquinol House
Danish: Vetoquinol UK Ltd Vetoquinol House Great Slade
English: Evaluation and conclusions on the benefit-risk balance On the basis of the available information the Committee considered that the treatment of bovine mastitis caused by Mycoplasma spp.
Danish: Vurdering og konklusioner om benefit/risk-forholdet På grundlag af de foreliggende oplysninger fandt udvalget, at behandling af bovin mastitis forårsaget af Mycoplasma spp.
English: Hence, this marketing authorisation holder suggested a deletion of Mycoplasma spp.
Danish: Indehaveren af markedsføringstilladelsen foreslog derfor, at Mycoplasma spp.
English: 288 02 Nymburk
Danish: Zámečnická 411 288 02 Nymburk Czech Republic
English: The aim of the referral procedure was to consider the available data and current scientific knowledge regarding the efficacy of parenterally administered tylosin formulations authorised for the treatment of bovine mastitis caused by Mycoplasma spp..
Danish: Formålet med henvisningsproceduren var at vurdere de foreliggende data og den aktuelle videnskabelige viden om virkningen af parenteralt administrerede tylosin-formuleringer, der er godkendt til behandling af bovin mastitis forårsaget af Mycoplasma spp.
English: The proportion of cows that were found to be M. bovis positive after 5 days of tylosin treatment (3g/cow/day i.m.)
Danish: Den andel af køerne, der blev fundet positiv for M. bovis efter 5 dages behandling med tylosin, (3 g/ko/dag im) var så høj som 53 % (8/15) (Jasper (1977)).
English: Finland considered that ineffective treatment of mycoplasma mastitis with tylosin presents a serious concern to animal and human health as it delays the correct diagnosis, enables spread of the pathogen to other cows, impedes efficient/prudent control measures and increases risk for the development of antimicrobial resistance due to unnecessary use of antimicrobials.
Danish: Finland fandt, at ineffektiv behandling af mycoplasma-mastitis med tylosin frembyder et alvorligt problem for dyrs og menneskers sundhed, da det forsinker korrekt diagnose, giver mulighed for spredning af patogenet til andre køer, hindrer effektive/forsvarlige kontrolforanstaltninger og øger risikoen for udvikling af antimikrobiel resistens som følge af unødig brug af antimikrobielle stoffer.
English: In this procedure none of the concerned applicants/marketing authorisation holders provided data in support of the use of parenterally administered tylosin in the treatment of bovine mastitis caused by Mycoplasma spp.
Danish: Ved denne procedure har ingen af de pågældende ansøgere/markedsføringstilladelsesindehavere forelagt data til støtte for anvendelsen af parenteralt administreret tylosin til behandling af bovin mastitis forårsaget af Mycoplasma spp.
English: • the CVMP considered that inefficient antimicrobial treatment of bovine mastitis caused by Mycoplasma spp.
Danish: • CVMP fandt, at ineffektiv antimikrobiel behandling med tylosin af bovin mastitis forårsaget af Mycoplasma spp.
English: The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.
Danish: Dataene om virkning underbygger ikke anvendelse af tylosin til behandling af bovin mastitis forårsaget af Mycoplasma spp.
English: or Mycoplasma bovis'.
Danish: eller Mycoplasma bovis", hvor det er relevant.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Danish: Ændringer i de relevante punkter i produktresuméet, etiketteringen og indlægssedlen
English: No pre-clinical or clinical data in support of the indication were provided from the applicants/marketing authorisation holders and no benefits of the use on tylosin in treatment of mastitis caused by Mycoplasma spp.
Danish: Ansøgerne/markedsføringstilladelsesindehaverne har ikke forelagt prækliniske eller kliniske data til støtte for indikationen, og der er ikke påvist fordele ved brug af tylosin til behandling af mastitis forårsaget af Mycoplasma spp.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Delete, where applicable, any specific dosing recommendation related to ‘bovine mastitis caused by Mycoplasma spp.'.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ Slet enhver specifik doseringsangivelse vedrørende "bovin mastitis forårsaget af Mycoplasma spp.
English: Furthermore, the Committee concluded that inefficient antimicrobial treatment with tylosin delays the correct diagnosis, impedes efficient control measures and enables the spread of the pathogen thus risking animal welfare, causing severe economic losses and a risk of increased antimicrobial use and resistance.
Danish: Udvalget konkluderede desuden, at ineffektiv antimikrobiel behandling med tylosin sinker korrekt diagnose, hindrer effektive kontrolforanstaltninger og giver mulighed for spredning af den patogene organisme, hvilket medfører risiko for tab af dyrevelfærd, svære økonomiske tab og øget brug af antimikrobielle stoffer samt øget resistens.
English: 189 Lure Cedex
Danish: Magny-Vernois B.P. 189 Lure Cedex
English: Mycoplasma is also easily spread via infected milk or milking equipment; thus, undetected or inefficiently treated mastitis in a cow may eventually lead to multiple infections in animals of different ages.
Danish: Uopdaget eller utilstrækkeligt behandlet mastitis hos en ko kan således efterhånden medføre multiple infektioner hos dyr med forskellig alder.
English: In addition to mastitis Mycoplasma spp.
Danish: Ud over mastitis er Mycoplasma spp.
English: In case of old products where data are sparse indications should be reviewed and revised, based on the current scientific knowledge, where appropriate.
Danish: For gamle produkter, hvor der er sparsomme data, bør
English: Screening of bulk tank milk can be used to detect infection in the herd and by pooled and/or individual sampling the carrier animals and the new infections are further tracked down.
Danish: Assay-tiden er reduceret til timer i modsætning til de næsten to uger, der behøves til konventionel dyrkning Screening af mælketankprøver kan anvendes til at konstatere infektion i besætningen, og ved at tage poolede og/eller individuelle prøver kan smittebærende dyr og nye infektioner opspores nærmere.