FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the concerns above and in line with the aforementioned recommendations from the EMA/CVMP/CHMP scientific advice to the European Commission, as a second step, the Committee was requested to review the marketing authorisations of all veterinary medicinal products containing colistin in combination with other antimicrobial substances for oral administration to food-producing species in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Croatian: Prema prethodno navedenim zabrinjavajućim podacima te u skladu s preporukama sadržanima u znanstvenom savjetu EMA-e/CVMP-a/CHMP-a Europskoj komisiji, od Odbora je zatraženo da kao sljedeći korak preispita odobrenja za stavljanje na tržište svih veterinarsko-medicinskih proizvoda koji sadržavaju kolistin u kombinaciji s drugim antimikrobicima za oralnu primjenu za vrste koje se upotrebljavaju za proizvodnju hrane kako bi se osigurala odgovorna uporaba tvari u cilju zaštite zdravlja životinja i ograničavanja mogućnosti nastanka rizika za javno zdravlje u budućnosti.
English: with elevated MICs to colistin could constitute a risk to public health.
Croatian: Bakterija Salmonella spp. s povišenim MIK-ovima na kolistin može predstavljati rizik za javno zdravlje.
English: In vitro antimicrobial synergy was identified by several MAHs and backed up by scientific publications, based on both a reduction of the MIC for target pathogens in the presence of the colistin combination and a reduction in the fractional inhibitory concentration index.
Croatian: Nekoliko nositelja odobrenja za stavljanje lijeka u promet utvrdilo je antimikrobnu sinergiju in vitro, a znanstvena su je izdanja podržala na temelju smanjenja MIK-a za ciljane patogene u prisutnosti kombinacije kolistina te smanjenja indeksa za frakcijske inhibitorne koncentracije.
English: • the CVMP considered that no convincing data were provided by the MAHs, in terms of clinical trials or other scientifically acceptable studies, as to clinical scenarios where colistin combination products are essential for food-producing animals in the EU compared to monotherapy products;
Croatian: • CVMP je smatrao da nositelji odobrenja za stavljanje lijeka u promet nisu pružili uvjerljive podatke o kliničkim ispitivanjima ili drugim znanstveno prihvatljivim ispitivanjima, kao što su klinički scenariji u kojima su u usporedbi s monoterapijskim proizvodima kombinirani proizvodi koji sadržavaju kolistin ključni za životinje koje se upotrebljavaju za proizvodnju hrane u EU-u;
English: Thus, colistin has re-emerged as a last-resort therapeutic option to treat infections due to MDR, XDR and PDR, lactose-fermenting and non-fermenting Gram-negative bacilli, including Pseudomonas aeruginosa and Acinetobacter baumannii.
Croatian: Stoga se kolistin ponovno pojavio kao posljednje rješenje za terapijsku opciju u liječenju infekcija izazvanih MDR-om, XDR-om i PDR-om, gram-negativnim bacilima koji fermentiraju laktozu i koji ne fermentiraju laktozu, uključujući Pseudomonas aeruginosa i Acinetobacter baumannii.
English: 7 Saint Herblon 44153 ANCENIS Cedex
Croatian: COOPHAVET S.A.S. B.P. 7 Saint Herblon 44153 ANCENIS Cedex
English: Chicken, turkeys
Croatian: Pilići, purani
English: Gastrointestinal infection caused by E. coli (colibacillosis) is not a recognised clinical disease in foals or adult horses and no data were provided to support the use of colistin in foals, therefore this target species should be removed.
Croatian: valjana opravdanja u prilog indikacija za bakteriju Salmonella spp. Gastrointestinalna infekcija prouzročena bakterijom E. coli (kolibaciloza) nije priznata klinička bolest u ždrebadi ili odraslih konja i nisu dostavljeni podaci koji bi govorili u prilog primjeni kolistina u ždrebadi, stoga je potrebno ukloniti ovu ciljanu vrstu.
English: The broad-spectrum activity of colistin against Gram-negative bacteria involves binding to lipid A, the anchor for lipopolysaccharide and the main constituent of the outer membrane of many bacteria
Croatian: Širok spektar djelovanja kolistina u borbi protiv gram-negativnih bakterija uključuje vezanje na lipid A, uporište za lipopolisaharid te glavni sastojak vanjske membrane brojnih bakterija
English: Specifically, in EU countries with known higher consumptions of colistin products, minimum inhibitory concentration (MIC) distributions were higher for Salmonella spp.
Croatian: Naime, u zemljama EU-a s poznatim višim potrošnjama proizvoda koji sadržavaju kolistin distribucije minimalne inhibitorne koncentracije (MIK) bile su više za izolate bakterije Salmonella spp. iz svinja i pilića, pri čemu je njih 77 % bilo razvrstano kao rezistentno.
English: NUTRIVET TOTAL, pó para suspensão oral, para vitelos e cordeiros
Croatian: NUTRIVET TOTAL, pó para suspensão oral, para vitelos e cordeiros ampicilin trihidrat kolistin sulfat
English: Having considered all data submitted in writing, the CVMP concluded that the benefit-risk balance for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally to food-producing species is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance.
Croatian: Uzimajući u obzir sve dostavljene pisane podatke, CVMP je zaključio da je omjer koristi i rizika za sve veterinarsko-medicinske proizvode koji sadržavaju kolistin u kombinaciji s ostalim antimikrobicima za oralnu primjenu za vrste koje proizvode hranu negativan zbog nedostatka kliničke važnosti te s obzirom na pretjerano izlaganje kolistinu, koje bi moglo predstavljati mogući rizik za zdravlje životinja i ljudi zbog ubrzavanja rezistencije na kolistin.
English: NEOMIX COMPLEX Neomycin sulfate Colistin sulphate
Croatian: NEOMIX COMPLEX neomicin sulfat kolistin sulfat
English: Currently the status for relevant Gram-negative gastrointestinal pathogens (e.g. E. coli) in the EU is that MICs of colistin are very low and colistin colonic concentrations are very high (e.g. 20 times above the MIC) such that a monotherapy product will suffice for these indications.
Croatian: Trenutačno je status za odgovarajuće gram-negativne gastrointestinalne patogene (npr. E. coli) u EU-u da su MIK-ovi kolistina vrlo niski, a koncentracije kolistina u debelom crijevu vrlo visoke (npr. 20 puta veće od MIK-a), tako da će za ove indikacije biti dovoljan proizvod za monoterapiju.
English: In May 2014 the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin as sole active substance for oral administration to food-producing species (EMEA/V/A/106).
Croatian: Direktive 2001/82/EZ za sve veterinarsko-medicinske proizvode koji sadržavaju kolistin kao jedinu djelatnu tvar za oralnu primjenu za životinjske vrste koje se upotrebljavaju za proizvodnju hrane (EMEA/V/A/106).
English: On these points, no convincing data were provided by the MAHs, in terms of clinical trials or other scientifically acceptable studies, as to clinical scenarios where colistin combination products are essential for food-producing animals in the EU compared to monotherapy products.
Croatian: U vezi s time nositelji odobrenja za stavljanje lijeka u promet nisu pružili uvjerljive podatke u pogledu kliničkih ispitivanja ili drugih znanstveno prihvatljivih ispitivanja, kao što su klinički scenariji u kojima su u usporedbi s monoterapijskim proizvodima kombinirani proizvodi koji sadržavaju kolistin ključni za životinje koje se upotrebljavaju za proizvodnju hrane u EU-u.
English: the CVMP has recommended the withdrawal of the marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally as referred in Annex I.
Croatian: CVMP je preporučio povlačenje odobrenja za stavljanje lijeka u promet za sve veterinarsko-medicinske proizvode koji sadržavaju kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu kao što je navedeno u Prilogu I.
English: With the renewed use of colistin use in human medicine, particularly as a last-resort therapeutic option to treat infections due to multidrugresistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR), lactose-fermenting and non-fermenting Gram-negative bacilli, including Pseudomonas aeruginosa and Acinetobacter baumannii, then there are potential public health concerns with continued veterinary use of the substance.
Croatian: Uz obnovljenu primjenu kolistina u humanoj medicini, osobito kao posljednje rješenje u terapijskoj opciji za liječenje infekcija prouzročenih gram-negativnim bacilima koji fermentiraju laktozu i koji ne fermentiraju laktozu, a koji su rezistentni na više lijekova (MDR), prošireno rezistentni (XDR) i rezistentni na sve lijekove (PDR), uključujući bacile Pseudomonas aeruginosa i Acinetobacter baumannii, s nastavljanjem veterinarske primjene tvari moguće su zabrinutosti za javno zdravlje.
English: In this procedure the CVMP was requested to review the marketing authorisations of all veterinary medicinal products containing colistin in combination with other antimicrobial substances for oral administration to food-producing species in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Croatian: U ovom je postupku od CVMP-a zatraženo preispitivanje odobrenja za stavljanje na tržište svih veterinarsko-medicinskih proizvoda koji sadržavaju kolistin u kombinaciji s drugim antimikrobicima za oralnu primjenu za vrste koje se upotrebljavaju za proizvodnju hrane kako bi se osigurala odgovorna uporaba tvari u cilju zaštite zdravlja životinja i ograničenja mogućeg rizika za javno zdravlje u budućnosti.
English: Considering the significant number of products containing colistin authorised in the EU it was considered appropriate to follow a stepwise approach based on risk for the revision of summary of the product characteristics of products containing colistin.
Croatian: Uzimajući u obzir znatan broj proizvoda koji sadržavaju kolistin odobrenih u EU-u, smatralo se primjerenim pri procjeni sažetka opisa svojstava lijeka za lijekove koji sadržavaju kolistin slijediti postupni pristup temeljen na riziku.
English: Therefore, the CVMP recommended the withdrawal of the marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Croatian: Stoga je CVMP preporučio povlačenje odobrenja za stavljanje lijeka u promet za sve veterinarskomedicinske proizvode koji sadržavaju kolistin u kombinaciji s drugim antimikrobicima za oralnu primjenu.
English: Oral administration individually
Croatian: Pojedinačna oralna primjena
English: E. coli septicaemia is a recognised disease in neonatal foals that can be sometimes be expressed as diarrhoea, among other symptoms.
Croatian: Sepsa prouzročena bakterijom E. coli priznata je bolest u neonatalne ždrebadi koja katkad, između ostalih simptoma, može imati za posljedicu proljev.
English: 34 rue Jean Monnet ZI D'Etiché BP20341
Croatian: Francuska QALIAN 34 rue Jean Monnet ZI D'Etiché
English: Justification of colistin combination products
Croatian: Opravdanje kombiniranih proizvoda koji sadržavaju kolistin
English: Colistin sulphate mg/g mg/g
Croatian: amoksicilin trihidrat kolistin sulfat mg/g mg/g
English: Concurrent E. coli related gastrointestinal diseases (e.g. septicaemia) were identified by MAHs as occurring as complications from the original gastrointestinal disease through either direct systemic spread or immunosuppression.
Croatian: Nositelji odobrenja za stavljanje lijeka u promet utvrdili su da se istodobne gastrointestinalne bolesti koje se povezuju s bakterijom E. coli javljaju kao komplikacije izvorne gastrointestinalne bolesti putem izravnog sustavnog širenja ili imunosupresije.
English: For food-producing animals in the EU/EEA today, field studies have shown that it is used primarily for pigs including group treatments and prevention of diarrhoea caused by E. coli and Salmonella spp., as first-choice http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm Lim LM et al. 2010 Resurgence of colistin: a review of resistance, toxicity, pharmacodynamics, and dosing.
Croatian: Sales of veterinary antimicrobial agents in 26 EU/EEA countries in 2012. Fourth ESVAC report. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm Lim LM et al.
English: Overall summary of the scientific evaluation of all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally (see Annex I)
Croatian: Cjelokupan sažetak znanstvenog vrednovanja svih veterinarsko-medicinskih proizvoda koji sadržavaju kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu (vidjeti Prilog I.)
English: Pigs and chickens (except laying)
Croatian: Svinje i pilići (osim nesilica)
English: Historically, this instability of polymyxin resistance, and the absence of horizontal gene transfer of these mutations, was thought to reduce the risk of rapid spread of resistance to colistin
Croatian: Povijesno gledajući, smatralo se da ta nestabilnost rezistencije na polimiksin i izostanak horizontalnog prijenosa gena tih mutacija smanjuju rizik brzog širenja rezistencije na kolistin Međutim, važno je napomenuti da stabilna rezistencija na subkliničkoj razini (heterorezistencija) može ostati nezapažena konvencionalnim tehnikama kultura/osjetljivosti
English: It belongs to the polymyxin therapeutic class and is identical to polymyxin E. Colistin is used for the treatment and prevention of diseases caused by sensitive bacteria (e.g. Escherichia coli) in pigs, poultry, rabbits, cattle, sheep and goats.
Croatian: Kolistin se upotrebljava za liječenje i sprječavanje bolesti uzrokovanih osjetljivim bakterijama (npr. Escherichia coli) u svinja, peradi, zečeva, goveda, ovaca i koza.
English: For gastrointestinal indications, there are also concerns if colistin combinations products are necessary over monotherapy.
Croatian: Kad je riječ o indikacijama za gastrointestinalni trakt, također postoje zabrinutosti jesu li kombinirani proizvodi koji sadrže kolistin u prednosti pred monoterapijom.
English: 7 Saint Herblon 44153 ANCENIS
Croatian: Bugarska COOPHAVET S.A.S. B.P. 7 Saint Herblon 44153 ANCENIS
English: Commission Regulation (EC) No 1177/2006 of 1 August 2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry http://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:32006R1177&from=en de Jong A et al. 2012 Pan-European monitoring of susceptibility to human-use antimicrobial agents in enteric bacteria isolated from healthy food-producing animals.
Croatian: Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry http://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:32006R1177&from=en de Jong A et al.
English: Colistin sulphate Spiramycin adipate
Croatian: kolistin sulfat spiramicin adipat
English: Via Corassori, 62 41100 Modena Italy
Croatian: Industria Italiana Integratori Trei S.p.A. Via Corassori, 62 41100 Modena Italy
English: Oral, via drinking water
Croatian: Oralno, putem vode za piće
English: In a previous Article 35 referral procedure for all veterinary medicinal products containing colistin to be administered orally the Committee agreed a harmonised indication, a limitation of the duration of treatment up to 7 days and warning sentences on prudent use.
Croatian: Odbor je postigao suglasnost oko usklađene indikacije, ograničenja liječenja u trajanju do sedam dana i rečenica upozorenja o opreznoj uporabi.
English: Chicken, pigs Oral use
Croatian: Pilići, svinje Oralna primjena
English: Via Piana 265 47032 Bertinoro Italy
Croatian: 47032 Bertinoro Italy
English: Powder for oral suspension for administration in drinking water
Croatian: Prašak za oralnu suspenziju za primjenu u vodi za piće
English: BELCOSPIRA ORAL prášek pro přípravu perorálního roztoku
Croatian: BELCOSPIRA ORAL prášek pro přípravu perorálního roztoku kolistin sulfat spiramicin adipat
English: Colistin sulphate Erythromycin estolate
Croatian: kolistin sulfat eritromicin estolat
English: Netherlands Dopharma B.V. Zalmweg 24
Croatian: Nizozemska Dopharma B.V.
English: Oral paste
Croatian: Oralna pasta
English: Powder for administration in drinking water or milk
Croatian: Prašak za primjenu u vodi za piće ili u mlijeku
English: Powder for use in drinking water
Croatian: Prašak za primjenu u vodi za piće
English: Cattle, chickens, pigs
Croatian: Goveda, pilići, svinje
English: Powder for oral use via drinking water
Croatian: Prašak za oralnu primjenu putem vode za piće
English: Oral solution Chickens and pigs
Croatian: Oralna otopina Pilići i svinje Oralna primjena
English: In addition, the MAHs were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005).
Croatian: Za negastrointestinalne indikacije ne mogu se utvrditi valjana terapijska načela te stoga kombinacija ne nudi prednost pred svojim djelatnim tvarima kada se primjenjuju kao proizvodi s jednom tvari, kao što je opisano u smjernicama CVMP-a o farmaceutskim proizvodima s fiksnim kombinacijama (EMEA/CVMP/83804/2005).
English: Pigs, chickens In drinking water use
Croatian: Svinje za tov Primjena u vodi za piće
English: In view of the information available in the reports of the EMA European Surveillance of Veterinary Antimicrobial Consumption
Croatian: S obzirom na informacije dostupne u izvješćima u okviru EMA-inog
English: In drinking water use
Croatian: Primjena u vodi za piće
English: No proprietary data or valid justifications could be provided in support of prevention and prophylaxis claims.
Croatian: U prilog tvrdnjama o sprečavanju i profilaksi nisu pruženi podaci proizvođača niti valjana opravdanja.
English: Mixed in feeding stuffs
Croatian: Pomiješano s hranom za životinje
English: Pigs, rabbits Oral
Croatian: Svinje, zečevi
English: Via Emilia, 285 40064 Ozzano Emilia Italy
Croatian: 40064 Ozzano Emilia Italy
English: In feed use
Croatian: Primjena u hrani za životinje
English: Колитетравит / COLI - TETRAVIT
Croatian: Колитетравит / COLITETRAVIT
English: “However, severe nosocomial infections due to multidrug-resistant (MDR) Gram-negative bacteria now account for high morbidity and mortality in man. Colistin is therefore nowadays a last resort drug in human medicine in the context of treatment of infections caused by MDR Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae), for which mortality can be extremely high.”
Croatian: Stoga je danas kolistin posljednje moguće rješenje u humanoj medicini u kontekstu liječenja infekcija uzrokovanih bakterijama Pseudomonas aeruginosa, Acinetobacter baumannii i Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) rezistentnima na više lijekova, kod kojih mortalitet može biti iznimno visok.”
English: has forced clinicians to reintroduce toxic systemic colistin treatment in the form of its less toxic inactive prodrug, colistin methanesulfonate, as a last-resort antimicrobial for infections with such bacteria, which are frequently the cause of healthcare-associated infections
Croatian: Nedavni globalni porast gram-negativnih bakterija u humanoj medicini koje su rezistentne na više lijekova, prošireno rezistentne i rezistentne na sve lijekove prisilio je kliničare na ponovno uvođenje toksičnog sustavnog liječenja kolistinom u obliku manje toksičnog neaktivnog prolijeka, kolistina metan sulfonata, kao posljednjeg rješenja antimikrobika za infekcije takvim bakterijama koje su često uzrok infekcija povezanih sa zdravstvenom skrbi
English: Powder for oral use
Croatian: Prašak za oralnu primjenu
English: For example, the current status for relevant Gram-negative gastrointestinal pathogens (e.g. E. coli) in the EU is that MICs to colistin are very low and colistin colonic concentrations are very high (e.g. 20 times more than the MIC) such that a monotherapy product could suffice for these indications.
Croatian: Primjerice, trenutačni status za odgovarajuće gram-negativne gastrointestinalne patogene (npr. E. coli) u EU-u jest da su MIK-ovi na kolistin vrlo niski, a koncentracije kolistina u debelom crijevu vrlo visoke (npr.
English: Pigs, chicken (broilers)
Croatian: Svinje, pilići (tovni)
English: 35 referral procedure monotherapy products demonstrated the same efficacy as colistin combination products.
Croatian: U većini kliničkih ispitivanja dostupnih u ovom postupku upućivanja u skladu s člankom 35. proizvodi za monoterapiju pokazali su jednaku učinkovitost kao i kombinirani proizvodi koji sadržavaju kolistin.
English: COLISULTRIX, geriamieji milteliai
Croatian: COLISULTRIX, geriamieji milteliai trimetoprim kolistin sulfat
English: Pigs, calves Oral use
Croatian: Svinje, telad Oralna primjena
English: Lithuania Lavet Pharmaceuticals Ltd. Ottó u. 14.
Croatian: Lavet Pharmaceuticals Ltd.
English: Ampicillin trihydrate Colistin sulphate
Croatian: ampicilin trihidrat kolistin sulfat
English: BELCOSPIRA ORAL, geriamieji milteliai
Croatian: BELCOSPIRA ORAL, geriamieji milteliai spiramicin adipat kolistin sulfat
English: Oral powder, for use in drinking water or liquid feed
Croatian: Oralni prašak, za primjenu u vodi za piće ili tekućoj hrani za životinje
English: Dopharma B.V. Zalmweg 24
Croatian: Dopharma B.V.
English: indications for colistin combination products.
Croatian: Isto se primjenjuje na kombinirane proizvode
English: Calves, sheep and goats, pigs, ponies, chickens, turkeys (excluding hens)
Croatian: Telad, ovce i koze, svinje, poniji, pilići, purani (isključujući pure)
English: Polymyxins have no clinically useful activity against Gram-positive bacteria, Gram-negative cocci, anaerobes and Mollicutes including Mycoplasma spp.
Croatian: Polimiksini su aktivni osobito u borbi protiv širokog raspona gram-negativnih bacila (npr. E. coli, Salmonella spp. i P. aeruginosa), uključujući bacile koji pokazuju karbapenemsku rezistenciju, kao i određene bacile Mycobacterium spp. Polimiksini nemaju klinički korisno djelovanje u borbi protiv gram-pozitivnih bakterija, gram-negativnih koka, anaeroba i molikuta, uključujući Mycoplasma spp.
English: Calves, pigs, chickens (other than laying hens), turkeys
Croatian: Telad, svinje, pilići (osim kokoši nesilica), purani
English: Pig, calves, poultry (chicken)
Croatian: Svinje, telad, perad (pilići)
English: Pharmaceuticals Ltd. Ottó u.14
Croatian: Ottó u.14
English: Romania Industria Italiana Integratori Trei
Croatian: Rumunjska Industria Italiana Integratori Trei S.p.A Viale Corassori, 62
English: Pig, calves, poultry (chicken, turkey), pigeon
Croatian: Svinje, telad, perad (pilići, purani), golubovi
English: Neomycin sulfate
Croatian: kolistin sulfat neomicin sulfat
English: Oral powder for use in drinking water or liquid feed
Croatian: Oralni prašak za primjenu u vodi za piće ili tekućoj hrani za životinje
English: Calves and lambs
Croatian: Ždrebad, telad