FrancophonIA/ELRC3.0 huggingface dataset:
English: Catry, B et al. 2015 Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health.
Croatian: 2015 Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health.
English: Fite A et al. 2013 Longitudinal analyses of gut mucosal microbiotas in ulcerative colitis in relation to patient age and disease severity and duration.
Croatian: 2013 Longitudinal analyses of gut mucosal microbiotas in ulcerative colitis in relation to patient age and disease severity and duration.
English: Liu YY et al. 2015 Emergence of plasmid-mediated colistin resistance mechanism MCR-1 in animals and human beings in China: a microbiological and molecular biological study.
Croatian: 2015 Emergence of plasmid-mediated colistin resistance mechanism MCR-1 in animals and human beings in China: a microbiological and molecular biological study.
English: A recent paper identified another risk of colistin products and Salmonella spp.
Croatian: Najnovijim je dokumentom utvrđen još jedan rizik proizvoda koji sadržavaju kolistina i bakterije Salmonella spp.
English: Human infections with such highly resistant bacteria are associated with higher patient morbidity and mortality, higher costs and longer length of hospital stay
Croatian: Humane infekcije takvim visoko rezistentnim bakterijama povezane su s većim morbiditetom i mortalitetom bolesnika, većim troškovima i duljim bolničkim liječenjem
English: COLIMIX (116 g/kg /40 g/kg), prémistura medicamentosa para alimento medicamentoso para suínos
Croatian: COLIMIX (116 g/kg /40 g/kg), pré-mistura medicamentosa para alimento medicamentoso para suínos
English: Farma vet Ltd. 40 Otec Paisii str. Shumen
Croatian: Bugarska Farma vet Ltd. 40 Otec Paisii str.
English: Specific control programmes for salmonellosis in food-producing animals have been implemented in EU countries.
Croatian: Posebni programi nadzora za salmonelozu u životinja koje se upotrebljavaju za proizvodnju hrane provedeni su u svim zemljama EU-a.
English: Previous CVMP conclusions applicable to colistin combination products
Croatian: Prethodni zaključci CVMP-a koji se primjenjuju na kombinirane proizvode kolistina
English: There are also products available for parenteral, intramammary and intrauterine administration, which are not within the scope of this referral.
Croatian: Također su dostupni proizvodi za parenteralnu, intramamarnu i intrauterinu primjenu, koji nisu unutar područja ovoga postupka upućivanja.
English: No published data is available that has identified the mechanism by which synergism could occur for colistin combinations.
Croatian: Nisu dostupni objavljeni podaci koji su utvrdili mehanizam kojim može doći do sinergizma za kombinacije kolistina.
English: Until recently, polymyxin resistance had involved only chromosomal mutations but had never been reported via horizontal gene transfer.
Croatian: Sve donedavno rezistencija na polimiksin uključivala je samo mutacije kromosoma, ali nikad nije zabilježena putem horizontalnog prijenosa gena.
English: This is a very different situation in Europe since colistin has traditionally only been used in veterinary medicine and not critically important for human health.
Croatian: Situacija u Europi se time uvelike promijenila jer se kolistin tradicionalno upotrebljavao samo u veterinarskoj medicini i nije bio od presudne važnosti za zdravlje ljudi.
English: Also, it is unclear whether at the time of systemic complications from colibacillosis the main clinical disease is still the gastrointestinal disease or the systemic complications.
Croatian: Također, nije jasno je li u vrijeme sustavnih komplikacija uzrokovanih kolibacilozom glavna klinička bolest i dalje gastrointestinalna bolest ili sustavne komplikacije.
English: In the light of the increase in bacterial resistance to antimicrobial substances, discussions are ongoing in the EU and on an international level on how to contain and minimise this phenomenon for the benefit of human and animal health.
Croatian: S obzirom na povećanje bakterijske rezistencije na antimikrobne tvari, trenutačno se na razini EU-a i na međunarodnoj razini vode rasprave o tome kako tu pojavu obuzdati i smanjiti na najmanju moguću mjeru radi dobrobiti zdravlja ljudi i životinja.
English: Pardon B et al. 2012 Prospective study on quantitative and qualitative antimicrobial and anti-inflammatory drug use in white veal calves.
Croatian: 2012 Prospective study on quantitative and qualitative antimicrobial and anti-inflammatory drug use in white veal calves.
English: Scientific conclusions and grounds for the withdrawal of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za povlačenje odobrenja za stavljanje lijeka u promet
English: In this context, colistin combination products are not utilised under prudent use principles nor fulfil the criteria outlined in the fixed combinations guideline for the approval of these products.
Croatian: U tom kontekstu, kombinirani proizvodi koji sadržavaju kolistin ne koriste se u skladu s načelima oprezne uporabe i ne ispunjavaju kriterije naznačene u smjernicama za fiksne kombinacije za odobrenje tih proizvoda.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, and marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, vrsta životinja, putova primjene i nositelja odobrenja za stavljanje lijeka u promet u državama članicama
English: Snitkin ES et al. 2013 Genomic insights into the fate of colistin resistance and Acinetobacter baumannii during patient treatment.
Croatian: 2013 Genomic insights into the fate of colistin resistance and Acinetobacter baumannii during patient treatment.
English: Callens B et al. 2012 Prophylactic and metaphylactic antimicrobial use in Belgian fattening pig herds.
Croatian: 2012 Prophylactic and metaphylactic antimicrobial use in Belgian fattening pig herds.
English: Several scientific reports and EU surveillance data have demonstrated continued very low level of resistance to colistin in food-producing animals, as well as reduced levels of resistance to several other antimicrobials used in colistin combination products, despite the wide use of these products in the EU for some years.
Croatian: Nekoliko znanstvenih izvješća i EU-ovi podaci o nadzoru pokazali su neprekidnu vrlo nisku razinu rezistencije na kolistin u životinja koje se upotrebljavaju za proizvodnju hrane, kao i smanjene razine rezistencije na nekoliko drugih antimikrobnih sredstava koji se primjenjuju u kombiniranim proizvodima koji sadržavaju kolistin, unatoč širokoj primjeni tih proizvoda nekoliko godina.
English: The disk diffusion test is applied routinely worldwide yet is seldom reliable due to the inability of colistin to regularly diffuse in the agar and produce a consistent concentration gradient.
Croatian: Ispitivanje difuzije diska rutinski se primjenjuje diljem svijeta, no rijetko je pouzdano zbog nemogućnosti redovite difuzije kolistina u agaru i proizvodnje dosljednog koncentracijskog gradijenta.
English: Colistin combination products are seen to serve a role for these more complex production-related diseases and clinical studies are available for some combinations, which demonstrated efficacy for some conditions.
Croatian: Smatra se da kombinirani proizvodi koji sadržavaju kolistin imaju ulogu u ovim složenijim bolestima povezanima s proizvodnjom, a za neke su kombinacije dostupna klinička ispitivanja koja su pokazala učinkovitost za neka stanja.
English: Regarding combinations of colistin with other antimicrobials the advice indicates that “The marketing authorisations for these products should be reviewed and unless sound justification can be provided that the combination is in line with responsible use principles, combination products should be withdrawn.”
Croatian: U pogledu kombinacija kolistina s drugim antimikrobicima, u savjetu se navodi da je „potrebno preispitati odobrenja za stavljanje na tržište za ove proizvode te da, ako se ne može pružiti ispravno opravdanje da je kombinacija u skladu s načelima odgovorne uporabe, kombinaciju proizvoda treba povući s tržišta.”
English: Romania Lavet Pharmecuticals LTD.
Croatian: Rumunjska Lavet Pharmecuticals LTD.
English: 3 restricting the indications, target species, and duration of treatment of the concerned products, as well as adding prudent use warnings to the product information.
Croatian: 3 kojom se ograničavaju indikacije, ciljane vrste i trajanje liječenja za dotične proizvode te kojom se informacijama o proizvodu dodaju upozorenja o opreznoj uporabi.
English: This means that with the lack of international standard techniques for colistin susceptibility testing no agreed standards exist for in vitro synergy evaluation for colistin combinations.
Croatian: To znači da uz nedostatak međunarodnih standardnih tehnika za ispitivanje osjetljivosti kolistina za kombinacije kolistina ne postoje dogovoreni standardi za in vitro sinergijsko ocjenjivanje.
English: The use of combination products represents a risk of unnecessary use of colistin in cases where no additional benefit has been shown over the use of one substance alone.
Croatian: Primjena kombiniranih proizvoda predstavlja rizik od nepotrebne primjene kolistina u slučajevima u kojima nije pokazana dodatna prednost pred primjenom samo jedne tvari.
English: Since the discovery in China, MCR-1 plasmid-mediated colistin resistance has been reported in a number of countries worldwide.
Croatian: Nakon otkrića u Kini MCR-1 rezistencija na kolistin posredovana plazmidima prijavljena je u brojnim zemljama diljem svijeta.
English: These additional clinical needs can include a broader spectrum of antimicrobial coverage in the body to either extend antimicrobial coverage to the rest of the body as well as the gastrointestinal tract (e.g. gastrointestinal infection plus septicaemia), or extra antimicrobial coverage within the gastrointestinal tract due to extenuating circumstances (e.g. antimicrobial resistance or polymicrobial infections).
Croatian: Te dodatne kliničke potrebe mogu uključivati širi spektar antimikrobne pokrivenosti u tijelu kako bi se antimikrobna pokrivenost proširila na ostatak tijela te na gastrointestinalni trakt (npr. gastrointestinalna infekcija plus sepsa) ili kako bi došlo do dodatne antimikrobne pokrivenosti unutar gastrointestinalnog trakta zbog olakšavajućih okolnosti (npr. antimikrobne rezistencije ili polimikrobnih infekcija).
English: Pogue JM et al. 2011 Revisiting ‘older' antimicrobials in the era of multidrug resistance.
Croatian: 2011 Revisiting ‘older' antimicrobials in the era of multidrug resistance.
English: In light of the renewed use of colistin use in human medicine and its critical importance for public health then it is essential to ensure prudent use of the substance in veterinary medicine in order to avoid an increase in the development of antimicrobial resistance.
Croatian: S obzirom na ponovne primjene kolistina u humanoj medicini i njegove važnosti za javno zdravlje, nužno je osigurati opreznu uporabu tvari u veterinarskoj medicini kako bi se izbjeglo povećanje antimikrobne rezistencije.
English: Thus, it is no longer the case that colistin-resistant bacteria in animals are unrelated to public health and the example found in China does demonstrate that transferable mcr-1 gene colistin resistance can occur in food animals and meat products and potentially constitute a public health risk.
Croatian: Stoga više nije slučaj da bakterije rezistentne na kolistin nisu povezane s javnim zdravljem, a primjer iz Kine pokazuje da se rezistencija gena mcr-1 na kolistin može pojaviti u životinja koje se upotrebljavaju za proizvodnju hrane i proizvodima od mesa te da potencijalno predstavljaju rizik za javno zdravlje.
English: This advice critically reviewed information on the use of colistin in food-producing animals in the EU, its effect on the development of resistance to this category of antimicrobial agents in bacterial species that are of importance for human and animal health, and the possible impact on human and animal health.
Croatian: U tom su savjetu kritički preispitane informacije o uporabi kolistina u životinja za proizvodnju hrane u EU-u, njegovim učincima na razvoj rezistencije na ovu kategoriju antimikrobnih agensa u bakterijskih vrsta koje su važne za zdravlje ljudi i životinja te mogućem utjecaju na zdravlje ljudi i životinja.
English: Treatment failures could compromise foal health in these cases.
Croatian: U tim slučajevima neuspješna liječenja mogu ugroziti zdravlje ždrebadi.
English: In veterinary medicine, it is used typically as the sulphate salt for oral preparations and as the methanesulphonate for parenteral administration.
Croatian: U veterinarskoj medicini obično se primjenjuje kao sulfatna sol za oralne pripravke te kao metansulfonat za parenteralnu primjenu.
English: Due to colistin's new status as critically important in human medicine, the public health impact of the current or future use of colistin products in animals needs to be re-assessed at this time.
Croatian: Zahvaljujući novom statusu kolistina kao presudnog proizvoda u humanoj medicini, potrebno je provesti ponovnu procjenu utjecaja koji na javno zdravlje ima trenutačna ili buduća uporaba proizvoda kolistina u životinja.
English: • the CVMP considered that the development of antimicrobial resistance to colistin is considered a risk for human health as colistin is also used as a last resort treatment in human medicine in the context of treatment of specific highly drug-resistant bacterial infections;
Croatian: • CVMP je smatrao da se razvoj antimikrobne rezistencije na kolistin smatra rizikom za zdravlje ljudi jer se kolistin također primjenjuje kao posljednje rješenje u liječenju u humanoj medicini u kontekstu liječenja specifičnih bakterijskih infekcija koje su vrlo rezistentne na lijekove;
English: A substantial change has occurred over the last five years regarding the importance of colistin in human and veterinary medicine - from a molecule used only in veterinary medicine, colistin has become a critically important molecule in human medicine.
Croatian: U proteklih pet godina došlo je do znatnije promjene u pogledu važnosti kolistina u humanoj i veterinarskoj medicini: kolistin je od molekule koja se primjenjuje samo u veterinarskoj medicini
English: On the status of colistin as a critically important antimicrobial in human medicine, the advice stated:
Croatian: U opisu kolistina kao presudnog antimikrobika u humanoj medicini u savjetu je naznačeno sljedeće:
English: While in cases involving other substances used in veterinary medicine there were still therapeutic options for human medicine, in this case any potential food-chain related contributions to colistin resistance in human medicine would lead to no therapeutic options for human infections against MDR, XDR and PDR bacteria.
Croatian: Iako u slučajevima koji obuhvaćaju primjenu ostalih tvari u veterinarskoj medicini i dalje postoje terapijske opcije za humanu medicinu, u ovom bi slučaju svi mogući doprinosi vezani uz prehrambeni lanac rezistenciji na kolistin u humanoj medicini doveli do izostanka terapijskih opcija za humane infekcije u borbi protiv MDR, XDR i PDR bakterija.
English: No specific reasons could be identified for the need of a colistin combination product for food-producing animals in the EU with either an improvement of activity (synergistic or additive activity), or broadening of the activity spectrum.
Croatian: Ne može se utvrditi poseban razlog za potrebom kombiniranog proizvoda koji sadržava kolistin za životinje koje se upotrebljavaju za proizvodnju hrane u EU-u, uz poboljšanje djelovanja (sinergijsko ili zbrojno djelovanje) ili širenje spektra djelovanja.
English: The end result is an unnecessary use of colistin.
Croatian: Krajnji je rezultat nepotrebna primjena kolistina.
English: Landman D et al. 2008 Polymyxins revisited.
Croatian: 2008 Polymyxins revisited.
English: Murgašova 5 949 01 Nitra Slovakia
Croatian: 949 01 Nitra Slovakia
English: In conclusion, colistin combination products are intended to address different clinical needs to monotherapy products.
Croatian: Zaključno, kombinirani proizvodi koji sadržavaju kolistin namijenjeni su za rješavanje različitih kliničkih potreba za monoterapijskim proizvodima.
English: Colistin is a cationic, multicomponent lipopeptide antibacterial agent produced by cultures of Bacillus polymyxa var. colistinus.
Croatian: Kolistin je kationski, višekomponentni lipopeptidni antibakterijski agens dobiven iz kultura Bacillus polymyxa var. colistinus.
English: Concepts of colistin combination synergy are more relevant in human medicine since low doses of colistin are injected parenterally with other antimicrobials in order to avoid toxicity.
Croatian: Koncepti sinergije kombinacije kolistina od veće su važnosti u humanoj medicini jer se male doze kolistina ubrizgavaju parenteralno s drugim antimikrobnim lijekovima kako bi se izbjegla toksičnost.
English: Combinations of colistin with other antimicrobials are available for group treatments of gastrointestinal and respiratory infections in food-producing animals in some European Member States.
Croatian: Kombinacije kolistina s drugim antimikrobnim lijekovima dostupne su za skupno liječenje gastrointestinalnih i respiratornih infekcija u životinja koje se koriste za proizvodnju hrane u nekim europskim državama članicama.
English: Vodovodna 20a 10000 Zagreb Croatia
Croatian: Arnika Veterina d.o.o. Vodovodna 20a 10000 Zagreb Croatia
English: The vast majority of consumption of polymyxins in food-producing animals is accounted for by colistin administered orally, in a variety of different formulations (e.g. premix, powder, oral solutions).
Croatian: Velika većina potrošnje polimiksina u životinja za proizvodnju hrane odnosi se na oralnu primjenu kolistina, u mnogim različitim oblicima (npr. premiks, prašak, oralna otopina).
English: In addition, colistin lacks therapeutic activity against inherently resistant species, including the genera Serratia, Stenotrophomonas and Proteus
Croatian: Osim toga, kolistinu nedostaje terapijsko djelovanje u borbi protiv rezistentnih vrsta, uključujući rodove Serratia, Stenotrophomonas i Proteus
English: Therefore, the CVMP concluded that no gastrointestinal indications could be supported for colistin combination products.
Croatian: Stoga je CVMP zaključio da se nijedna gastrointestinalna indikacija ne može podržati za kombinirane proizvode koji sadržavaju kolistin.
English: Thus, the use of colistin in foals is considered to present a serious risk in relation to target animal safety and foals cannot be supported as a target animal species for colistin combination products.
Croatian: Stoga se smatra da primjena kolistina u ždrebadi predstavlja ozbiljan rizik za sigurnost ciljanih životinja te se ždrebad ne može podržati kao ciljana životinjska vrsta za kombinirane proizvode koji sadržavaju kolistin.
English: Lo-Ten-Foe JR et al. 2007 Comparative evaluation of the VITEK 2, disk diffusion, Etest, broth microdilution,and agar dilution susceptibility testing methods for colistin in clinical isolates, including heteroresistant Enterobacter cloacae and Acinetobacter baumannii strains.
Croatian: 2007 Comparative evaluation of the VITEK 2, disk diffusion, Etest, broth microdilution,and agar dilution susceptibility testing methods for colistin in clinical isolates, including heteroresistant Enterobacter cloacae and Acinetobacter baumannii strains.
English: No clinical studies or justification was given for the under-dosing which could constitute a risk to public health by promoting colistin resistant bacteria.
Croatian: Nije pruženo nijedno kliničko ispitivanje ili opravdanje za doziranje manje od potrebnoga koje bi predstavljalo rizik za javno zdravlje promicanjem bakterija rezistentnih na kolistin.
English: The risk identified by maintaining this indication is that it promotes the treatment of an unknown clinical disease, leading to treatment failures because the true cause (e.g. viral, other bacteria, protozoans, parasites) is unaffected by colistin combination treatments.
Croatian: Rizik utvrđen zadržavanjem ove indikacije jest da promiče liječenje nepoznate kliničke bolesti, dovodeći do neuspješnog liječenja jer liječenje kombinacijom kolistina ne utječe na pravi uzrok (npr. virusni uzrok, druge bakterije, protozoi, paraziti).
English: Until recently it was felt the public health concerns were small due to the known characteristics of colistin resistance identified in veterinary medicine, including that these colistinresistant bacteria are rare, possess only non-transferable genetic elements to other bacteria and are unstable, meaning colistin-resistant bacteria do not persist.
Croatian: Sve donedavno smatralo se da su zabrinutosti za javno zdravlje male zbog poznatih karakteristika rezistencije na kolistin utvrđenih u veterinarskoj medicini, uključujući činjenicu da su te bakterije rezistentne na kolistin rijetke, da posjeduju samo neprenosive genetske elemente na druge bakterije i da su nestabilne, što znači da bakterije rezistentne na kolistin ne opstaju.
English: Luxembourg VETOQUINOL Magny Vernois 70200 Lure
Croatian: Luksemburg VETOQUINOL Magny Vernois 70200 Lure
English: As stated previously, this has no clinical relevance for colistin combination products, since colistin is not absorbed from the gastrointestinal tract and thus will never participate in combating polymicrobial infections in other target tissues.
Croatian: Kao što je prethodno navedeno, to ne predstavlja kliničku važnost za kombinirane proizvode koji sadrže kolistin jer se kolistin ne apsorbira iz gastrointestinalnog trakta i stoga nikada neće sudjelovati u borbi protiv polimikrobnih infekcija u ostalim ciljanim tkivima.
English: The CVMP considered that the end result of using colistin combination products instead of monotherapy is an unnecessary use of colistin.
Croatian: CVMP je smatrao da je krajnji rezultat primjene kombiniranih proizvoda koji sadržavaju kolistin umjesto monoterapije nepotrebna primjena kolistina.
English: Arguments for polymicrobial infections were mostly theoretical and only discussed by MAHs in relation to respiratory and skin indications.
Croatian: Argumenti za polimikrobne infekcije bili su uglavnom teorijski te su nositelji odobrenja za stavljanje lijeka u promet o njima raspravljali samo u odnosu na respiratorne i kožne indikacije.
English: Non-gastrointestinal indications are considered an unnecessary use of colistin as the substance does not contribute to any therapeutic effect of other organs infected with bacterial infections.
Croatian: Negastrointestinalne indikacije smatraju se nepotrebnom primjenom kolistina jer tvar ne pridonosi nijednom terapijskom učinku ostalih organa zaraženih bakterijskim infekcijama.
English: In the aforementioned Commission Decision it is stated that in line with the agreed stepwise approach “The combinations of colistin with another antimicrobial substance and the non-oral administration of products containing colistin may be addressed as a next step following the completion of this referral procedure.”
Croatian: U prethodno navedenoj Odluci Komisije navedeno je da u skladu s dogovorenim postupnim pristupom „kombinacije kolistina s drugim antimikrobicima te neoralna primjena proizvoda koji sadržavaju kolistin mogu biti sljedeće pitanje koje će se riješiti nakon dovršetka ovog postupka upućivanja.”
English: Thus, it is unknown if a combination product provides an added value over a monotherapy product for this indication.
Croatian: Stoga nije poznato ima li za ovu indikaciju kombinirani proizvod dodanu vrijednost pred proizvodom za monoterapiju.
English: This emergence of MCR-1 in animals and human-related bacteria heralds the breach of the last group of antibiotics, polymyxins, by plasmid-mediated transferable resistance.
Croatian: Ova pojava gena MCR-1 u životinja i bakterija koje se odnose na ljude najavljuje prodor posljednje skupine antibiotika, polimiksina, prenosivom rezistencijom posredovanom plazmidima.