FrancophonIA/ELRC3.0 huggingface dataset:
English: Given the recent critical importance of colistin in human medicine, then veterinary use can only be justified under prudent use principles, which is not the case for colistin combinations products for non-gastrointestinal indications.
Croatian: S obzirom na nedavnu ključnu važnost kolistina u humanoj medicini, primjena u veterini može se opravdati samo u okviru načela o opreznoj uporabi, što nije slučaj za kombinirane proizvode koji sadržavaju kolistin za negastrointestinalne indikacije.
English: However, concerns were raised whether gastrointestinal indications for colistin combinations products are justified when it would be more prudent to use a monotherapy product.
Croatian: Međutim, postavljena su pitanja jesu li gastrointestinalne indikacije za kombinirane proizvode koji sadržavaju kolistin opravdane s obzirom na to da bi bilo opreznije bilo primijeniti proizvod za monoterapiju.
English: It is recognised that colistin combination products could be efficacious for the treatment and metaphylaxis of gastrointestinal diseases caused by E. coli susceptible to both active substances in piglets, poultry, neonatal calves and lambs, provided the dose and duration of treatment are adjusted according to those previously recommended by CVMP.
Croatian: Prihvaća se činjenica da kombinirani proizvodi koji sadržavaju kolistin mogu biti učinkoviti za liječenje i metafilaksu gastrointestinalnih bolesti prouzročenih bakterijom E. coli osjetljivom na obje djelatne tvari u prasadi, peradi, neonatalne teladi i janjadi, pod uvjetom da doza i trajanje liječenja budu prilagođeni u skladu s onima koje je prethodno preporučio CVMP.
English: No specific clinical studies were provided for invasive E. coli secondary to gastrointestinal disease.
Croatian: Nisu omogućena posebna klinička ispitivanja za invazivnu bakteriju E. coli, sekundarnu u odnosu na gastrointestinalnu bolest.
English: Gales AC et al. 2011 Contemporary activity of colistin and polymyxin B against a worldwide collection of Gram-negative pathogens: results from the SENTRY Antimicrobial Surveillance Program (2006-09).
Croatian: 2011 Contemporary activity of colistin and polymyxin B against a worldwide collection of Gram-negative pathogens: results from the SENTRY
English: This combined with the lack of quality clinical studies and of other credible evidence to confirm the added value of colistin combination products over monotherapy, combined with lack of compliance with prudent use principles and the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005), leads to the conclusion that there is no valid justification for the use of colistin combination products in veterinary medicine.
Croatian: Ta činjenica, u kombinaciji s nedostatkom kliničkih ispitivanja kakvoće i drugih vjerodostojnih dokaza za potvrdu dodane vrijednosti kombiniranih proizvoda koji sadržavaju kolistin u odnosu na monoterapiju, te u kombinaciji s nedostatkom usklađenosti s načelima oprezne uporabe i smjernicama CVMP-a o farmaceutskim fiksnim kombinacijama proizvoda (EMEA/CVMP/83804/2005) dovodi do zaključka da ne postoji valjano opravdanje za primjenu kombiniranih proizvoda koji sadržavaju kolistin u veterinarskoj medicini.
English: This was supported by a recent EU commissioned ad hoc expert group on antimicrobial resistance (AMEG) as well as a recent Article 35 referral procedure on veterinary medicinal products containing colistin as sole active substance to be administered orally.
Croatian: To je podržala nedavna ad hoc stručna skupina EU-a o antimikrobnoj rezistenciji (AMEG) te postupak upućivanja u skladu s člankom 35. o veterinarsko-medicinskim proizvodima koji sadržavaju kolistin kao jedinu djelatnu tvar za oralnu primjenu.
English: More virulent strains resulting in more severe disease can further lead to septicaemia and/or immunosuppression with the result of either multi-organ disease or polymicrobial infections.
Croatian: Zarazniji sojevi koji rezultiraju ozbiljnijom bolešću mogu dalje dovesti do sepse i/ili imunosupresije s posljedicom bolesti više organa ili polimikrobnih infekcija.
English: Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf European Medicines Agency, European Surveillance of Veterinary Antimicrobial Consumption.
Croatian: Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf projekta europskog nadzora potrošnje veterinarskih antimikrobnih sredstava EMA-e
English: As even a limited use of colistin combinations products is deemed to lead to unnecessary use of colistin and could potentially contribute to the development of antimicrobial resistance, the measures discussed above were not considered sufficient to mitigate the identified risk.
Croatian: Budući da bi čak i ograničena primjena kombiniranih proizvoda koji sadržavaju kolistin mogla dovesti do nepotrebne primjene kolistina te bi mogla pridonijeti razvoju antimikrobne rezistencije, prethodno navedene mjere nisu se smatrale dovoljnima za smanjenje utvrđenog rizika.
English: antimicrobials, the number of marketing authorisations per pharmaceutical form/route of administration and types of use, the products containing colistin only and administered orally (group treatment) were considered a priority.
Croatian: 2 o prodaji antimikrobnih sredstava, broju odobrenja za stavljanje lijeka u promet po farmaceutskom obliku / putu primjene i načinu primjene, proizvode koji sadržavaju samo kolistin i koji se primjenjuju oralnim putem (skupno liječenje) smatralo se prioritetnima.
English: Also, the previous Article 35 referral procedure confirmed a dose of 100,000 IU colistin per kg body weight daily for calves, lambs and pigs, and a dose of 75,000 IU colistin per kg body weight daily in poultry for 3-5 consecutive days.
Croatian: Prethodnim postupkom upućivanja u skladu s člankom 35. potvrđena je doza od 100 000 IU kolistina na kg tjelesne težine na dan za telad, janjad i svinje te doza od 75 000 IU kolistina na kg tjelesne težine na dan u peradi tijekom 3 - 5 uzastopnih dana.
English: Gastrointestinal infection caused by E. coli (colibacillosis) is not a recognised clinical disease in foals or adult horses.
Croatian: Gastrointestinalna infekcija prouzročena bakterijom E. coli (kolibaciloza) nije priznata klinička bolest u ždrebadi ili odraslih konja.
English: In the above mentioned Article 35 referral procedure (EMEA/V/A/106) for all veterinary medicinal products containing colistin as sole active substance for oral administration to food-producing species, the CVMP reached certain conclusions (described below) on some indications, dosages and target species, which would also apply to colistin combination products.
Croatian: U prethodno navedenom postupku upućivanja u skladu s člankom 35. (EMEA/V/A/106) za sve veterinarsko-medicinske proizvode koji sadržavaju kolistin kao jedinu djelatnu tvar za oralnu primjenu za vrste koje se upotrebljavaju za proizvodnju hrane CVMP je donio određene zaključke (opisane u nastavku) o nekim indikacijama, doziranjima i ciljanim vrstama, koji se također mogu primijeniti na kombinirane proizvode koji sadržavaju kolistin.
English: This is for the reason that colistin is not absorbed from the gastrointestinal tract after oral administration and thus does not contribute to the overall therapeutic efficacy for these indications.
Croatian: Razlog je tomu činjenica da se kolistin nakon oralne primjene ne apsorbira iz gastrointestinalnog trakta te stoga ne pridonosi cjelokupnoj terapeutskoj učinkovitosti za te indikacije.
English: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2015/10/WC500195687.pdf Magiorakos AP et al. 2012 Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance.
Croatian: 2012 Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance.
English: The same considerations taken for the colistin monotherapy products also apply to products containing colistin in combination with other antimicrobial substances.
Croatian: Ista razmatranja koja se uzimaju u obzir za monoterapijske proizvode također se primjenjuju na proizvode koji sadržavaju kolistin u kombinaciji s drugim antimikrobnim tvarima.
English: The current scientific literature does not support the use of colistin combination products in foals as its use could disrupt the gastrointestinal microflora balance, leading to a well-recognised fatal antimicrobial-associated colitis, typically associated with Clostridium difficile.
Croatian: Trenutačna znanstvena literatura ne podupire primjenu kombiniranih proizvoda koji sadržavaju kolistin u ždrebadi jer bi njihova primjena mogla poremetiti ravnotežu gastrointestinalne mikroflore, dovodeći do dobro poznatog smrtonosnog kolitisa povezanoga s antimikrobicima, koji se obično povezuje s bakterijom Clostridium difficile.
English: Some of the products included in the scope of this referral procedure are indicated for use in foals.
Croatian: Neki od proizvoda obuhvaćenih ovim postupkom upućivanja namijenjeni su za primjenu u ždrebadi.
English: This is especially a concern for certain colistin combination products (e.g. colistin and neomycin or colistin and oxytetracycline) where both active substances are not absorbed but yet the products are currently authorised with non-gastrointestinal tract indications.
Croatian: To osobito zabrinjava kad je riječ o određenim kombiniranim proizvodima koji sadržavaju kolistin (npr. kolistin i neomicin ili kolistin i oksitetraciklin) u kojima se djelatne tvari ne apsorbiraju, a proizvodi su trenutačno odobreni za indikacije negastrointestinalnog trakta.
English: Additionally, pharmacovigilance data have revealed no reports of lack of efficacy for colistin combination products.
Croatian: Osim toga, farmakovigilancijski podaci pokazali su da za kombinirane proizvode koji sadržavaju kolistin nema izvješća o nedostatku učinkovitosti.
English: However, no benefit could be demonstrated of using colistin combination products over monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even a limited use of colistin combination products was considered an unnecessary use of colistin.
Croatian: Međutim, nije dokazana korist primjene kombiniranih proizvoda u odnosu na monoterapiju i nisu utvrđene provedive mjere za smanjenje rizika kako bi se riješio utvrđeni potencijalni rizik za zdravlje ljudi jer se čak i ograničena primjena kombiniranih proizvoda koji sadržavaju kolistin smatra nepotrebnom primjenom kolistina.
English: Veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally to food-producing species represent commonly used antimicrobials in veterinary medicine.
Croatian: Veterinarsko-medicinski proizvodi koji sadržavaju kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu za vrste koje proizvode hranu predstavljaju antimikrobici koja se uobičajeno primjenjuju u veterinarskoj medicini.
English: Proprietary data, scientific references and expert reports were provided in this Article 35 referral procedure in support of some indications of some of the products included in the scope of the procedure.
Croatian: Podaci proizvođača, znanstveni referentni izvori i stručna izvješća dostavljena u ovome postupku upućivanja u skladu s člankom 35. idu u prilog određenim indikacijama nekih od proizvoda obuhvaćenih ovim postupkom.
English: Additionally, it was agreed that the suggested dose of 50,000 IU per kg body weight twice daily was reasonable.
Croatian: Nadalje, postignuta je suglasnost o opravdanosti preporučene doze od 50 000 IU na kg tjelesne težine na dan.
English: In the present Article 35 referral, several colistin combinations veterinary medicinal products were identified with colistin doses of below 50,000 IU per kg body weight.
Croatian: U ovom upućivanju u skladu s člankom 35. kod nekoliko veterinarsko-medicinskih kombiniranih proizvoda koji sadržavaju kolistin utvrđene su doze kolistina manje od 50 000 IU na kg tjelesne težine.
English: Via Caldera 21 20153 Milano Italy
Croatian: Virbac S.r.l. Via Caldera 21 20153 Milano Italy
English: Also, the clinical relevance of synergy with colistin combinations is highly doubtful for the reason that colonic concentrations of colistin alone are so much higher than the MIC (e.g. 20 times more than the MIC) for E. coli and other bacteria, as a monotherapy, hence there is no clinical added value for an in vitro synergy of colistin combinations.
Croatian: Nadalje, klinička važnost sinergije s kombinacijama kolistina vrlo je upitna jer su koncentracije samog kolistina u debelom crijevu mnogo više od MIK-a (npr. 20 pute više od MIK-a) za bakteriju E. coli i ostale bakterije, kao monoterapija, pa stoga nema klinički dodane vrijednosti za in vitro sinergiju kombinacija kolistina.
English: Colibacillosis is defined as an infection of the colon by Enterobacteriaceae, especially E. coli, resulting in a disease manifestation, typically diarrhoea and other manifestations in poultry.
Croatian: Kolibaciloza je definirana kao infekcija debelog crijeva prouzročena enterobakterijom, osobito bakterijom E. coli, koja rezultira manifestacijom bolesti, obično proljevom i ostalim manifestacijama u peradi.
English: The bactericidal effect of colistin (and polymyxin B) is the result of an interaction with divalent cations of the outer bacterial membrane, which causes a disruption of the cell structure, leakage of the cell contents and thereby cell lysis
Croatian: Bakterijsko djelovanje kolistina (i polimiksina B) posljedica je međudjelovanja s dvovalentnim kationima vanjske bakterijske membrane, što prouzročuje poremećaj stanične strukture, istjecanje staničnog sadržaja te staničnu lizu
English: • the CVMP considered that even a limited use of colistin combinations products is deemed to lead to unnecessary use of colistin and could potentially contribute to the development of antimicrobial resistance;
Croatian: • CVMP je smatrao da bi čak i ograničena primjena kombiniranih proizvoda koji sadržavaju kolistin mogla dovesti do nepotrebne primjene kolistina te bi mogla pridonijeti razvoju antimikrobne rezistencije;
English: Based on the information provided by MAHs, including proprietary data, scientific references and expert reports, a possible risk mitigation measure considered in this Article 35 referral was to further limit the use of colistin combination products to treatment of individual animals only and remove presentations of products intended for group treatment.
Croatian: Na temelju informacija koje su dostavili nositelji odobrenja za stavljanje lijeka u promet, uključujući podatke proizvođača, znanstvene referentne izvore i stručna izvješća, moguća mjera za smanjivanje rizika razmotrena u ovom postupku upućivanja u skladu s člankom 35. bila je daljnje ograničenje primjene kombiniranih proizvoda koji sadržavaju kolistin za liječenje samo pojedinih životinja te uklanjanje prezentacija proizvoda namijenjenih za skupno liječenje.
English: Premix for medicated feedingstuff in insoluble powder, to be administered orally properly mixed in solid feed.
Croatian: Premiks za ljekovitu hranu za životinje u obliku netopivog praška koji se primjenjuje oralno, pravilno pomiješan u krutoj hrani za životinje.
English: Colibacillosis is not a term used in equine medicine, but a term used for pigs, poultry and ruminants.
Croatian: Kolibaciloza nije izraz koji se upotrebljava u liječenju konja, nego izraz koji se upotrebljava u liječenju svinja, peradi i preživača.
English: Oral administration, after incorporation into the feed
Croatian: Oralna primjena, nakon dodavanja u hranu za životinje
English: ‘Sales of veterinary antimicrobial agents in 26 EU/EEA countries in 2013'.
Croatian: European Medicines Agency, European Surveillance of Veterinary Antimicrobial Consumption, 2015. ‘Sales of veterinary antimicrobial agents in 26 EU/EEA countries in 2013'.
English: Via Affarosa, 4 42010 - Rio Saliceto Italy
Croatian: 42010 - Rio Saliceto Italy
English: Centro Empresarial da Rainha, Lote 27 2050-501 Vila Nova da Rainha Portugal
Croatian: 2050-501 Vila Nova da Rainha
English: Quality, target animal safety, user safety, environmental risk and residues were not assessed in this referral procedure.
Croatian: U ovom postupku upućivanja nije provela procjena kakvoće, sigurnosti ciljanih životinja, sigurnosti za korisnike, rizika za okoliš i ostataka.
English: The risk to public health identified is that treatment of clinical or subclinical Salmonella infections with the objective to reduce the number of bacteria can interfere with EU control
Croatian: koji sadržavaju kolistin za indikacije za bakteriju Salmonella spp. Utvrđeni rizik za javno zdravlje jest da liječenje kliničkih ili subkliničkih infekcija bakterijom Salmonella radi smanjenja broja bakterija može ometati programe nadzora EU-a
English: Industria Italiana Integratori Trei S.P.A.
Croatian: Mađarska Industria Italiana Integratori Trei S.p.A.
English: However, these in vitro studies are unreliable because the major problem with using in vitro susceptibility methods for establishing efficacy of colistin combinations against bacteria is that the accuracy of the different techniques available such as broth microdilution, agar dilution, and Etest is questionable because of the cationic properties of colistin
Croatian: Međutim, ta ispitivanja in vitro nisu pouzdana jer glavni problem s primjenom metoda osjetljivosti za utvrđivanje učinkovitosti kombinacija kolistina u borbi protiv bakterija in vitro jest upitna točnost dostupnih različitih tehnika kao što su mikrodilucija u bujonu, dilucija u agaru i Etest, i to zbog kationskih
English: Biofilms are protective layers around bacteria that are formed, for example, in the
Croatian: Biofilmovi su zaštitni slojevi oko bakterija koji se, primjerice, stvaraju u probavnom traktu kao zajednice mukoznog biofilma
English: Polymicrobial gastrointestinal infections were not identified by the MAHs for the animal species and indications listed for their products.
Croatian: Nositelji odobrenja za stavljanje lijeka u promet nisu utvrdili polimikrobne gastrointestinalne infekcije za životinjske vrste i indikacije navedene za svoje lijekove.
English: Colamox 3200/640 Amoxicillin trihydrate Colistin sulphate
Croatian: Colamox 3200/640 amoksicilin trihidrat kolistin sulfat
English: Following the Article 35 referral procedure for veterinary medicinal products containing colistin as sole active substance (EMEA/V/A/106), colistin is no longer recommended for treatment of gastrointestinal infections caused by Salmonella spp.
Croatian: Nakon postupka upućivanja u skladu s člankom 35. za veterinarsko-medicinske proizvode koji sadržavaju kolistin kao jedinu djelatnu tvar (EMEA/V/A/106) kolistin se više ne preporučuje za liječenje gastrointestinalnih infekcija prouzročenih bakterijom Salmonella spp zbog negativne procjene koristi i rizika.
English: , polymyxins were the fifth most sold group of antimicrobials (6%), after tetracyclines (37%), penicillins (24%), sulfonamides (10%) and macrolides (7%).
Croatian: U vezi s ukupnom težinom životinja kod kojih je prisutan rizik liječenja diljem 26 zemalja EU-a/EGP-a, a za koje su bili dostupni podaci o prodaji veterinarskih proizvoda, polimiksini su bili peta po redu skupina najprodavanijih antimikrobika (6 %), nakon tetraciklina (37 %), penicilina (24 %), sulfonamida (10 %) i makrolida (7 %).
English: Most clinical studies provided in this Article 35 referral procedure demonstrated that monotherapy products shared the same efficacy as colistin combination products.
Croatian: Većina kliničkih ispitivanja dostupna u ovom postupku upućivanja u skladu s člankom 35. dokazala je da proizvodi za monoterapiju dijele jednaku učinkovitost kao i kombinirani proizvodi koji sadrže kolistin.
English: VETOQUINOL Magny Vernois 70200 Lure France
Croatian: Francuska VETOQUINOL Magny Vernois 70200 Lure
English: The same conclusion was reached in the recent Article 35 referral procedure on oral colistin monotherapy products.
Croatian: Isti je zaključak donesen u nedavnom postupku upućivanja u skladu s člankom 35. o proizvodima za oralnu monoterapiju kolistinom.
English: During a routine surveillance project on antimicrobial resistance in commensal E. coli from food animals in China, polymyxin resistance was shown to be singularly due to the plasmid-mediated mcr-1 gene Furthermore, this mcr-1 carriage in E. coli isolates was also found in 78 (15%) of 523 samples of raw meat products and 166 (21%) of 804 animals sampled during 2011-14.
Croatian: Nadalje, to prenošenje mcr-1 u izolate bakterije E. coli također je pronađeno u 78 (15 %) od 523 uzorka proizvoda od sirovog mesa te 166 (21 %) od 804 životinjska uzorka tijekom razdoblja 2011. - 2014.
English: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf as described in the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005).
Croatian: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf svojstava kolistina
English: Current European Committee on Antimicrobial Susceptibility Testing clinical breakpoints for Enterobacteriaceae are under revision because of these issues.
Croatian: Zbog tih se pitanja provodi pregled trenutačne kliničke točke prekida Europskog odbora za testiranje antimikrobne osjetljivosti za enterobakterije.
English: Pigs, chickens (except hens producing eggs for human consumption)
Croatian: Svinje, pilići (osim kokoši koje nesu jaja za prehranu ljudi)
English: Premix
Croatian: Premiks
English: In production animals, stresses in neonates and such related to weaning lead to dysbacteriosis and E. coli diarrhoea, which appear clinically similar.
Croatian: Naprezanja u novorođenčadi i naprezanja povezana s odbijanjem u životinja za proizvodnju dovode do disbakterioze i proljeva prouzročenog bakterijom E. coli, a to se dvoje klinički čini sličnim.
English: Grounds for withdrawal of the marketing authorisations
Croatian: Razlozi za povlačenje odobrenja za stavljanje lijeka u promet
English: CENAVISA, S.A. Camí Pedra Estela s/n. Reus (Tarragona)
Croatian: Španjolska CENAVISA, S.A. Camí Pedra Estela s/n.
English: • the CVMP concluded that the benefit-risk assessment for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally is negative and that the products could pose a potential risk to human health;
Croatian: • CVMP je zaključio da je procjena koristi i rizika za sve veterinarsko-medicinske proizvode koji sadržavaju kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu negativna te da bi proizvodi mogli predstavljati mogući rizik za zdravlje ljudi;
English: For non-gastrointestinal indications there are concerns of lack of justification for colistin combination products.
Croatian: Kad je riječ o negastrointestinalnim indikacijama, postoje zabrinutosti o nedostatku opravdanja za kombinirane proizvode koji sadržavaju kolistin.
English: Colistin sulphate mg/tablet mg/tablet
Croatian: oksitetraciklin hidroklorid kolistin sulfat mg/tablet mg/tablet