natgillin/translations-raw huggingface dataset:
Den vigtigste af de patogene arter er Mycoplasma bovis, der første gang blev isoleret fra bovin mastitis i USA i 1960'erne. 
The major pathogen among the genera is Mycoplasma bovis that was first isolated from bovine mastitis in the USA in the 1960s.
Der fandtes ikke internationalt anerkendte metoder til følsomhedsbestemmelse, da tylosin første gang blev godkendt til veterinær anvendelse, og der er ikke hidtil fremkommet nogen. 
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.
Den patogene organisme er stærkt smitsom og er årsag til svære økonomiske tab. 
The pathogen is highly contagious and causes severe economic losses.
I undersøgelsen foretaget af Biddle et al., 20033 blev der indsamlet mælkeprøver dagligt i 28 dage fra 10 malkekøer smittet med Mycoplasma spp. 
In the study by Biddle et al., 20033, milk samples were collected daily for 28 days from 10 Mycoplasma spp.
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. 
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.
Jasper var også blandt de første, der rejste tvivl om virkningen af antimikrobielle stoffer til behandling af mycoplasma-mastitis. 
Jasper was also one of the first to question the efficacy of antimicrobials in the treatment of mycoplasma mastitis.
Tylosin og dets fosfat- og tartratsalt anvendes i veterinærlægemidler til behandling af sygdomme forårsaget af tylosinfølsomme organismer. 
Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms.
Ud over spredning til andre kirtler er der mulighed for hæmatogen spredning af Mycoplasma til andre dele af kroppen, fx led, respirationsveje og ører. 
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.
Tylosin tilhører makroliderne, der er klassificeret som kritisk vigtige antimikrobielle stoffer både i veterinær-og humanmedicinen. 
Tylosin belongs to macrolides which have been classified as critically important antimicrobials both in veterinary and human medicine.
Makrolider er kategoriseret som kritisk vigtige antimikrobielle stoffer i både human- og veterinærmedicinen, dog anvendes tylosin ikke i humanmedicinen. 
Macrolides are categorised as critically important antimicrobials both in human and veterinary medicine however tylosin is not used in human medicine.
M. bovis er en stærkt smitsom yverpatogen, der let spredes. 
M. bovis is a highly contagious udder pathogen that is easily spread.
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. 
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.
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. 
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.
årsag til luftvejsinfektioner, arthritis og otitis (media) hos både ungkvæg og gammelt kvæg. 
causes respiratory infections, arthritis and otitis (media) both in young and old cattle.
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." 
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.
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. 
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.
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. 
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
Kvæg Svin Hunde 
Cattle Pigs Dogs
er årsag til en række infektioner, herunder luftvejssygdom, otitis media, arthritis og mastitis, hos kvæg verden over. 
causes a variety of infections including respiratory disease, otitis media, arthritis and mastitis in cattle worldwide.
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. 
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.
eller "bovin mastitis forårsaget af Mycoplasma bovis" bør slettes fra produktinformationen for veterinærmedicinske produkter, der indeholder tylosin og administreres parenteralt. 
or ‘bovine mastitis caused by Mycoplasma bovis' should be deleted from the product information for veterinary medicinal products containing tylosin that are administered parenterally.
4.2 Indikation(er) 
4.2 Indication(s) for use
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." 
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.'
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. 
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.
og "bovin mastitis forårsaget af Mycoplasma bovis" ikke længere kan opretholdes, 
or ‘bovine mastitis caused by Mycoplasma bovis' can no longer be maintained;
En grundig litteratursøgning efter nye data om virkningen af tylosin til behandling af mycoplasmamastitis resulterede ikke i nogen originale undersøgelser. 
A thorough literature search to find new data on the efficacy of tylosin in the treatment of mycoplasma mastitis revealed no original studies.
Forfatterne konkluderede, at risikoen for fejl øges, hvis der ikke 
The authors concluded that the risk of misdiagnosis is increased if multiple milk samples are not tested.
Dyrearter Administrationsvej 
Route of administration
Mastitis forårsaget af M. bovis afviger på flere måder fra infektioner forårsaget af størstedelen af de mere almindelige mastitis-patogener (fx Streptococcus spp. 
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.).
• 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. 
• 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.
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." 
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.'
med veterinærlægemidler indeholdende tylosin, der administreres parenteralt, ikke er effektiv, 
with veterinary medicinal products containing tylosin that are administered parenterally is not effective;
Videnskabelige konklusioner og begrundelser for ændringen af produktresuméet, etiketteringen og indlægssedlen 
Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
I tilfælde, hvor indikationen for et bestemt produkt specificerer den mastitis-forårsagende patogene organisme som Mycoplasma bovis, skal indikationen ligeledes slettes. 
In cases where the indication for a particular product specifies the mastitis pathogen as Mycoplasma bovis, the indication should also be deleted.
med veterinærmedicinske produkter indeholdende tylosin, der administreres parenteralt, ikke er effektiv. 
with veterinary medicinal products containing tylosin that are administered parenterally is not effective.
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. 
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.
M. bovis er en stærkt smitsom yverpatogen, der typisk medfører mastitis i flere kirtler, da den kan sprede sig hæmatogent. 
M. bovis is a highly contagious udder pathogen which typically causes mastitis that affects several quarters as it is capable of hematologic dissemination.
For at minimere risikoen for overførsel af resistens til offentligheden og til dyr bør al unødvendig anvendelse derfor omhyggeligt undgås. 
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.
I tilfælde, hvor indikationen for et bestemt produkt specificerer den mastitisforårsagende patogene organisme som Mycoplasma bovis, skal doseringsanvisningen ligeledes slettes. 
In cases where the indication for a particular product specifies the mastitis pathogen as Mycoplasma bovis, the dosing instruction should also be deleted.
slettes fra indikationerne vedrørende bovin mastitis for de pågældende tylosininjektionspræparater i EU. 
from the bovine mastitis indications for the concerned tylosin injectable products in the European Union.
Vurdering og konklusioner om benefit/risk-forholdet På grundlag af de foreliggende oplysninger fandt udvalget, at behandling af bovin mastitis forårsaget af Mycoplasma spp. 
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.
Indehaveren af markedsføringstilladelsen foreslog derfor, at Mycoplasma spp. 
Hence, this marketing authorisation holder suggested a deletion of Mycoplasma spp.
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. 
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..
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)). 
The proportion of cows that were found to be M. bovis positive after 5 days of tylosin treatment (3g/cow/day i.m.)
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. 
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.
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. 
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.
• CVMP fandt, at ineffektiv antimikrobiel behandling med tylosin af bovin mastitis forårsaget af Mycoplasma spp. 
• the CVMP considered that inefficient antimicrobial treatment of bovine mastitis caused by Mycoplasma spp.
Dataene om virkning underbygger ikke anvendelse af tylosin til behandling af bovin mastitis forårsaget af Mycoplasma spp. 
The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.
eller Mycoplasma bovis", hvor det er relevant. 
or Mycoplasma bovis'.
Ændringer i de relevante punkter i produktresuméet, etiketteringen og indlægssedlen 
Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
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. 
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.
DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ Slet enhver specifik doseringsangivelse vedrørende "bovin mastitis forårsaget af Mycoplasma spp. 
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.'.
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. 
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.
Magny-Vernois B.P. 189 Lure Cedex 
189 Lure Cedex
Uopdaget eller utilstrækkeligt behandlet mastitis hos en ko kan således efterhånden medføre multiple infektioner hos dyr med forskellig alder. 
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.
Ud over mastitis er Mycoplasma spp. 
In addition to mastitis Mycoplasma spp.
For gamle produkter, hvor der er sparsomme data, bør 
In case of old products where data are sparse indications should be reviewed and revised, based on the current scientific knowledge, where appropriate.
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. 
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.
Samlet resumé af den videnskabelige vurdering af veterinærlægemidler, der indeholder tylosin, administreres parenteralt og er bestemt til behandling af bovin mastitis forårsaget af Mycoplasma spp. 
Overall summary of the scientific evaluation of veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
anbefalede CVMP ændring af markedsføringstilladelserne for veterinærlægemidler indeholdende tylosin, der administreres parenteralt og er bestemt til behandling af bovin mastitis forårsaget af Mycoplasma spp. 
the CVMP has recommended the variation of the marketing authorisations for veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Finland bemærkede, at der findes veterinærmedicinske produkter, der indeholder tylosin, administreres parenteralt, er bestemt til behandling af bovin mastitis forårsaget af Mycoplasma spp. 
Finland noted that there are veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Dette vanskeliggør følsomhedsbestemmelse af Mycoplasma spp. 
For the same reasons sensitivity testing of Mycoplasma spp.
CVMP konkluderede følgelig, at indikationerne "bovin mastitis forårsaget af Mycoplasma spp." 
Consequently the CVMP concluded that the indications 'bovine mastitis caused by Mycoplasma spp.'
Prøverne blev podet direkte på mycoplasma-agar for at vurdere udskillelsesmønstret. 
infected dairy cows and directly plated on mycoplasma agar to evaluate shedding patterns.
Kvæg Får Geder Svin 
Cattle Calves Sheep Goats Pigs Dogs
Forudsat at indikationerne "bovin mastitis forårsaget af Mycoplasma spp." 
Provided that the indications 'bovine mastitis caused by Mycoplasma spp.'
forsinker korrekt diagnose, hindrer effektive kontrolforanstaltninger og giver mulighed for spredning af den patogene organisme, hvilket sætter dyrs sundhed og velfærd på spil, medfører alvorlige økonomiske tab og øger risikoen for antimikrobiel resistens som følge af øget behov for antimikrobiel behandling. 
with tylosin delays the correct diagnosis, impedes efficient control measures and enables the spread of the pathogen thus risking animal health and welfare, causing severe economic loss and increasing the risk of antimicrobial resistance due to increased need for antimicrobial treatment.
Ineffektiv behandling med tylosin af mastitis forårsaget af Mycoplasma 
Inefficient treatment of mastitis caused by Mycoplasma spp.
forsinker korrekt diagnose, hindrer effektive kontrolforanstaltninger, giver mulighed for spredning af den patogene organisme til andre dyr i besætningen med deraf følgende risiko for dyrenes sundhed og velfærd, øger behovet for antimikrobiel behandling og øger udviklingen af antimikrobiel resistens. 
with tylosin delays the correct diagnosis, impedes efficient control measures and enables the spread of the pathogen to other animals of the herd thus risking animal health and welfare along with increasing the need for antimicrobial treatment and development of antimicrobial resistance.
Grækenland Biovet JSC 39 Petar Rakov Str. 
Slovak Republic Biovet JSC 39 Petar Rakov Str.
Rumænien Cross Vetpharm Group Ltd. Broomhill Road, Tallaght Dublin 24 
United Kingdom Cross Vetpharm Group Ltd. Broomhill Road, Tallaght Dublin 24
Begrundelse for ændringen af produktresuméet, etiketteringen og indlægssedlen ud fra følgende betragtninger: 
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Slet enhver specifik doseringsangivelse vedrørende "bovin mastitis forårsaget af Mycoplasma spp. 
Delete, where applicable, any references to ‘bovine mastitis caused by Mycoplasma spp.
Foranstaltninger til risikohåndtering eller -begrænsning Udvalget fandt, at al omtale af indikationerne "bovin mastitis forårsaget af Mycoplasma spp." 
The Committee considered that all references to indications ‘bovine mastitis caused by Mycoplasma spp.'
Kvæg får 
Animal species
Den 10. april 2014 (skæringstidspunkt: 22. januar 2012) 
10 April 2014 (DLP:22 January 2012)
Skitse til informationsmateriale senest tre måneder efter Kommissionens afgørelse 
Outline of the education materials within 3 months after the EC decision
Betingelser for markedsføringstilladelsen 
Conditions to the marketing authorisations
Dette skal indgå i risikostyringsplanen og skal fremhæve risici, advarsler og overvågning i forbindelse med hepatotoksicitet 
This will be included in the risk management plan, highlighting the risks, warnings and monitoring of hepatotoxicity
De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaten sikrer, at indehaverne af markedsføringstilladelse opfylder følgende vilkår: 
National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):