natgillin/translations-raw huggingface dataset:
To be determined by Member States following EC decision 
Rok določijo države članice na podlagi sklepa Evropske komisije.
The MAHs should circulate a DHPC in accordance with the agreed key messages. 
Imetniki dovoljenja za promet z zdravilom bodo razposlali obvestilo za zdravstvene delavce (DHPC) v skladu z dogovorjenimi ključnimi sporočili.
0.5ml (1mg/ml) 14 Vials 
Subkutana uporaba Viala (steklena) 0,5ml (1mg/ml)
Route of administration 
14 Vial
These findings have since been verified. 
Te ugotovitve so bile od takrat preverjene.
The assay time has been reduced to hours as opposed to almost two weeks needed for the conventional culture. 
Čas poskusov se je skrajšal na nekaj ur v primerjavi s skoraj dvema tednoma, ki so potrebni za konvencionalne kulture.
Special media and atmosphere are required and the incubation period is long (7-10 days). 
Potrebni so posebni mediji in okolje, inkubacijska doba pa je dolga (7-10 dni).
was as high as 53% (8/15) (Jasper (1977)). 
), je znašal 53 % (8/15) (Jasper (1977)).
Monitoring the lack of efficacy is a part of the veterinary pharmacovigilance system. 
Spremljanje pomanjkanja učinkovitosti je del sistema veterinarske farmakovigilance.
(or Mycoplasma bovis) which are currently authorised or pending authorisations in the European Union. 
(ali Mycoplasma bovis), ki so trenutno odobrena ali čakajo na odobritev v Evropski uniji.
It may be administered by oral or parenteral routes. 
Lahko se daje po peroralni ali parenteralni poti.
29% of the composite samples (81/280) and 43% of the quarter milk samples (433/1008) did not yield growth of Mycoplasma. 
29 % sestavljenih vzorcev (81/280) in 43 % vzorcev mleka iz vimenske četrti (433/1008) ni povzročilo rasti mikoplazme.
Details of the treatment experiments are scarce, but altogether he described the results as unrewarding. 
Podrobnosti o poskusih zdravljenja so redki, vendar je rezultate opisal kot v celoti nezadovoljive.
The clinical signs vary but the milk loss is usually significant. 
Klinični znaki so različni, vendar je izguba mleka običajno precejšnja.
The authors concluded that the risk of misdiagnosis is increased if multiple milk samples are not tested. 
Avtorji so ugotovili, da se tveganje za napačno diagnozo poveča, če se ne testira več vzorcev mleka.
Infected cows may remain externally normal with few clinical signs, even in severe cases. 
Okužene krave lahko ostanejo navzven normalne z nekaj kliničnimi znaki, tudi v hudih primerih.
Mycoplasmas do not grow on conventional media; this hampers the diagnosis. 
Mikoplazme ne rastejo na konvencionalnih medijih, kar ovira diagnozo.
Since then it has spread to cattle worldwide and is known to cause severe economic losses in the herds affected. 
Od takrat se je razširila na govedo po vsem svetu in znano je, da povzroča hude gospodarske izgube v prizadetih čredah.
4.2 Indication(s) for use 
4.2 Indikacija(e) za uporabo
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. 
Negativni rezultat kultivacije po zdravljenju se je v preteklosti lahko zmotno razlagal kot bakteriološka ozdravitev, čeprav je trenutno znano le, da je to značilnost okužbe.
is difficult. 
težavno.
Furthermore, this indication should not be granted for the pending marketing authorisation applications (see Annex I). 
Poleg tega ta indikacija ne sme biti odobrena za vloge v postopku pridobivanja dovoljenja za promet (glejte Prilogo I).
Affected milk may seem normal but it may also be purulent and/or have abnormal and discoloured secretions. 
Prizadeto mleko se lahko zdi normalno, vendar je lahko tudi gnojno in/ali ima nenormalne in razbarvane izločke.
Current technologies such as Polymerase Chain Reaction (PCR) have enabled significantly quicker identification of M. bovis. 
Sodobne tehnologije, kot je polimerazna verižna reakcija (PCR), so omogočile bistveno hitrejše prepoznavanje bakterije M. bovis.
It is a major problem for milk production and animal welfare in the herds affected, and causes severe economic losses. 
Predstavlja veliko težavo za proizvodnjo mleka in dobro počutje živali v prizadetih čredah in povzroča hude gospodarske izgube.
He reported testing various antimicrobials, including tylosin. 
Poročal je o testiranju različnih protimikrobnih zdravil, vključno z tilozinom.
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. 
Odbor je sklenil, da je treba indikacije za uporabo prednostno omejiti na tiste, za katere je bila dokazana učinkovitost, in da se je treba izogibati splošnim indikacijam
The dose 3 g/cow/day is within the dose range widely authorised in Europe i.e. 4-10 mg/kg/day i.m. 
Odmerek 3 g/kravo/dan je v razponu, splošno odobrenem v Evropi, tj. 4-10 mg/kg/dan i.m.
The pathogen is highly contagious and causes severe economic losses. 
Patogen je zelo nalezljiv in povzroča velike gospodarske izgube.
It is active mostly against Gram-positive bacteria and mycoplasmas. 
Deluje predvsem proti po Gramu pozitivnim bakterijam in mikoplazmam.
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. 
Ta zdravila za uporabo v veterinarski medicini so navedena tudi za zdravljenje nekaterih drugih bolezni, vključno z dihalnimi in gastrointestinalnimi okužbami, vendar te indikacije ne sodijo na področje uporabe tega napotitvenega postopka.
Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms. 
Tilozin in njegove fosfatne in tartratne soli se uporabljajo v veterinarski medicini za zdravljenje stanj, ki jih povzročajo občutljivi organizmi.
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). 
Namesto tega je bilo objavljenih več obsežnih preglednih člankov, ki obravnavajo mikoplazmatski mastitis (Pfützner in Sachse (1996)4, Nicholas in Ayling (2003)5, Gonzalez in Wilson (2003)6, Maunsell et al. (2011)7, Fox (2012)8, Nicholas et al. (2016)9).
(see Annex I) 
(glejte Prilogo I)
Jasper was also one of the first to question the efficacy of antimicrobials in the treatment of mycoplasma mastitis. 
Jasper je bil tudi eden izmed prvih, ki je dvomil o učinkovitosti protimikrobnih zdravil pri zdravljenju mikoplazmatskega mastitisa.
(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. 
(glejte Prilogo I), in sicer je treba popraviti povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.
In 1977 Jasper 2 described natural resolution of the disease as unpredictable and recognised the danger of intermittently shedding cows. 
Leta 1977 je Jasper2 opisal naravni potek bolezni kot nepredvidljiv in prepoznal nevarnost pri kravah, pri katerih se patogen izloča občasno.
In case of old products where data are sparse indications should be reviewed and revised, based on the current scientific knowledge, where appropriate. 
Pri starih zdravilih, kjer so podatki skopi, je treba, kjer je to potrebno, indikacije pregledati in spremeniti na podlagi obstoječega strokovnega znanja.
The major pathogen among the genera is Mycoplasma bovis that was first isolated from bovine mastitis in the USA in the 1960s. 
Glavni patogen iz rodu je bakterija Mycoplasma bovis, ki je bila prvič izolirana iz mastitisa pri govedu v ZDA v 60. letih 20. stoletja.
For the same reasons sensitivity testing of Mycoplasma spp. 
Iz istih razlogov je preizkušanje občutljivosti Mycoplasma spp.
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. 
Poleg širjenja na druge vimenske četrti je mogoče hematološko širjenje mikoplazme na druge dele telesa, npr. sklepe, dihala in ušesa.
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. 
Imetnik dovoljenja za promet za referenčno zdravilo „Tylan 200 mg/ml“ Elanco Animal Health se je strinjal s pomisleki in ugotovil, da je premalo zanesljivih predkliničnih in kliničnih podatkov v podporo ustrezni indikaciji.
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 
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 brez trdne klinične osnove.
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. 
Na splošno velja, da vsaka uporaba protimikrobnih zdravil povečuje nevarnost za protimikrobno odpornost, zato se je treba za zmanjšanje tveganja za prenos te odpornosti na ljudi in živali skrbno izogibati vsem nepotrebnim uporabam.
Tylosin belongs to macrolides which have been classified as critically important antimicrobials both in veterinary and human medicine. 
Tilozin pripada makrolidom, ki so razvrščeni kot kritično pomembna protimikrobna zdravila tako v veterinarski kot v humani medicini.
Macrolides are categorised as critically important antimicrobials both in human and veterinary medicine however tylosin is not used in human medicine. 
Makrolidi so kategorizirani kot kritično pomembne protimikrobne učinkovine tako v humani kot veterinarski medicini, vendar pa se tilozin ne uporablja v humani medicini.
Often more than one quarter is affected and there is a marked drop in milk production. 
Pogosto je prizadetih več vimenskih četrti in zaradi tega je občutno zmanjšana proizvodnja mleka.
or Mycoplasma bovis'. 
ali Mycoplasma bovis“.
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 
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in predlagateljev/imetnikov dovoljenj za promet z zdravilom v državah članicah
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. 
Uporaba tilozina kot zdravila za uporabo v veterinarski medicini je bila obravnavana v dokumentu o presoji odbora CVMP glede uporabe makrolidov, linkozamidov in streptograminov (MLS) pri živalih za proizvodnjo živil v Evropski uniji: razvoj odpornosti in vpliv na zdravje ljudi in živali (EMA/CVMP/SAGAM/741087/2009)1.
The proportion of cows that were found to be M. bovis positive after 5 days of tylosin treatment (3g/cow/day i.m.) 
Delež krav, ki so bile pozitivne na bakterijo M. bovispo 5-dnevnem zdravljenju s tilozinom (3 g/kravo/dan i.m.
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. 
Skupno stališče teh preglednih člankov je, da je mikoplazmatski mastitis neozdravljiv ali neodziven na protimikrobno zdravljenje in da je za preprečevanje širjenja patogena v čredi ključnega pomena hitra opredelitev okuženih živali.
M. bovis is a highly contagious udder pathogen that is easily spread. 
Bakterija M. bovis je zelo nalezljiv patogen vimena, ki se zlahka širi.
Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae. 
Tilozin je makrolidni antibiotik, ki ga proizvajajo bakterije družine Streptomyces fradiae.
M. bovis is a highly contagious udder pathogen which typically causes mastitis that affects several quarters as it is capable of hematologic dissemination. 
M. bovis je zelo nalezljiv patogen vimena, ki običajno povzroča mastitis, ki prizadene več vimenskih četrti, saj se lahko širi po hematološki poti.
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. 
Zato je Finska 22. junija 2016 začela napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin, ki se dajejo parenteralno in so namenjena zdravljenju mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.
It is ineffective against Enterobacteriaceae. 
Ne deluje proti bakterijam družine Enterobacteriaceae.
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. 
Ker so bile zgoraj navedene indikacije več let vključene v informacije o teh zdravilih za uporabo v veterinarski medicini, je Odbor ocenil, da bi bilo treba zagotoviti informacije o odpravi indikacije in informacijam o zdravilu dodati naslednji opozorilni stavek: „Podatki o učinkovitosti ne podpirajo uporabe tilozina za zdravljenje mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.“.
from the bovine mastitis indications for the concerned tylosin injectable products in the European Union. 
iz indikacij za mastitis pri govedu za zadevna zdravila za injiciranje, ki vsebujejo tilozin, v Evropski uniji.
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. 
Presajanje večjega rezervoarja mleka se lahko uporablja za odkrivanje okužbe v čredi, nadaljnja izsleditev živali prenašalk in novih okužb pa je mogoča z združenim in/ali individualnim vzorčenjem.
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. 
Finska je opozorila, da v obstoječi znanstveni literaturi ni navedena indikacija „mastitis pri govedu, ki ga povzroča bakterija Mycoplasma bovis“, ampak da se splošno navaja, da ni nobenih možnosti protimikrobnega zdravljenja mastitisa pri govedu, ki ga povzroča mikoplazma.
A thorough literature search to find new data on the efficacy of tylosin in the treatment of mycoplasma mastitis revealed no original studies. 
Pri temeljitem pregledu literature, da bi našli nove podatke o učinkovitosti tilozina pri zdravljenju mikoplazmatskega mastitisa, ni bilo mogoče najti izvirnih študij.
In cases where the indication for a particular product specifies the mastitis pathogen as Mycoplasma bovis, the dosing instruction should also be deleted. 
V primerih, kjer indikacija za določeno zdravilo določa patogen mastitisa kot Mycoplasma bovis, je treba izbrisati tudi navodila za odmerjanje.
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. 
V času, ko je bil tilozin prvič odobren za uporabo v veterinarski medicini, ni bila na voljo mednarodno dogovorjena metodologija za preizkušanje občutljivosti in taka metodologija še vedno ne obstaja.
Hence, this marketing authorisation holder suggested a deletion of Mycoplasma spp. 
S tem je ta imetnik dovoljenja za promet predlagal brisanje bakterije Mycoplasma spp.
In the study by Biddle et al., 20033, milk samples were collected daily for 28 days from 10 Mycoplasma spp. 
V študiji Biddle et al. 20033 so 28 dni vsak dan zbirali vzorce mleka 10 krav molznic, okuženih z bakterijo Mycoplasma spp., in jih nanesli neposredno na mikoplazmatski agar za oceno vzorcev izločanja.
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.). 
Mastitis, ki ga povzroča M. bovis, se na več načinov razlikuje od okužb z večino najpogostejših povzročiteljev mastitisa (npr. Streptococcus spp., Staphylococcus 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.. 
Namen napotitvenega postopka je bil proučiti razpoložljive podatke in sedanja znanstvena spoznanja o učinkovitosti parenteralnega dajanja formulacij tilozina, odobrenih za zdravljenje mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.
causes a variety of infections including respiratory disease, otitis media, arthritis and mastitis in cattle worldwide. 
po vsem svetu povzroča različne okužbe, vključno z boleznijo dihal, vnetjem srednjega ušesa, artritisom in mastitisom pri govedu.
causes respiratory infections, arthritis and otitis (media) both in young and old cattle. 
poleg mastitisa povzroča dihalne okužbe, artritis in otitis, tako pri mladem kot pri starem govedu.
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. 
V tem postopku nobeden od zadevnih prosilcev/imetnikov dovoljenja za promet ni predložil podatkov v podporo uporabi tilozina, ki se daje parenteralno, za zdravljenje mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.
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. 
Kljub izboljšanim diagnostičnim tehnologijam dejstvo, da se ta patogen lahko občasno izloča v mleko okuženih krav, še vedno pomeni velik izziv pri diagnozi mikoplazmatskega mastitisa (in pri ocenjevanju uspešnosti protimikrobnega zdravljenja).
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. 
Finska je menila, da neučinkovito zdravljenje mikoplazmatskega mastitisa s tilozinom predstavlja resno zaskrbljenost za zdravje živali in ljudi, povzroča zamude pri postavljanju pravilne diagnoze, omogoča širjenje patogena na druge krave, ovira učinkovite/preudarne ukrepe za nadzor in povečuje tveganje za razvoj protimikrobne odpornosti zaradi nepotrebne uporabe protimikrobnih zdravil.
The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp. 
Podatki o učinkovitosti ne podpirajo uporabe tilozina za zdravljenje mastitisa pri govedu, ki ga povzroča bakterija 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. 
Predlagatelji/imetniki dovoljenja za promet niso predložili nobenih predkliničnih ali kliničnih podatkov v podporo indikaciji, prav tako pa niso bile ugotovljene prednosti uporabe tilozina pri zdravljenju mastitisa, ki ga povzroča bakterija Mycoplasma spp.
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. 
Poleg tega je zaključil, da neučinkovito zdravljenje s protimikrobnimi zdravili s tilozinom upočasni pravilno diagnozo, ovira učinkovite ukrepe za nadzor in omogoča širjenje patogena, s čimer ogroža dobro počutje živali, povzroča hude gospodarske izgube in tveganje povečane rabe protimikrobnih zdravil in odpornosti.
• 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. 
• v odsotnosti predkliničnih ali kliničnih podatkov in na podlagi sedanjih znanstvenih dognanj je odbor CVMP presodil, da zdravljenje mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp., z zdravili za uporabo v veterinarski medicini, ki vsebujejo tilozin in se dajejo parenteralno, ni učinkovito;
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. 
Odbor je ocenil, da bi se lahko v primeru, če bi se indikacija „mastitis pri govedu, ki ga povzroča bakterija Mycoplasma spp.“ ali „mastitis pri govedu, ki ga povzroča bakterija Mycoplasma bovis“ izbrisala iz indikacij parenteralnih zdravil s tilozinom, razmerje med koristmi in tveganji teh zdravil še naprej obravnavalo kot pozitivno.
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. 
Finska je opozorila, da obstajajo zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin in ki se dajejo parenteralno ter so namenjena zdravljenju mastitisa pri govedu, ki ga povzroča bakterija družine 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. 
odbor CVMP je priporočil spremembo dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo tilozin, ki se daje parenteralno, in so namenjena zdravljenju mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.
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. 
Tako lahko neodkrit ali neučinkovito zdravljen mastitis pri kravi sčasoma vodi do več okužb pri živalih različnih starosti.
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. 
Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo tilozin, za parenteralno dajanje, ki so namenjena zdravljenju mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.
SPECIAL WARNING(S) 
Vsem zdravilom dodajte: POSEBNO(A) OPOZORILO(A)