FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Do nedavnega je prevladovalo mnenje, da so pomisleki v zvezi z javnim zdravjem majhni zaradi znanih značilnosti odpornosti proti kolistinu, ugotovljenih v veterinarski medicini, vključno s tem, da so bakterije, odporne proti kolistinu, redke, da imajo samo genetske elemente, ki jih ne morejo prenašati na druge bakterije, in da so nestabilne, kar pomeni, da bakterije, odporne proti kolistinu, niso trajne.
English: Arguments for polymicrobial infections were mostly theoretical and only discussed by MAHs in relation to respiratory and skin indications.
Slovenian: Argumenti v zvezi s polimikrobnimi okužbami so bili večinoma teoretični in so jih imetniki dovoljenj za promet z zdravilom navajali v povezavi z respiratornimi in kožnimi indikacijami.
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).
Slovenian: Te dodatne klinične potrebe lahko vključujejo širši spekter protimikrobnega delovanja v telesu, ki bodisi širi protimikrobno delovanje na druge dele telesa in prebavni trakt (npr. okužba prebavil plus septikemija) ali dodatno protimikrobno delovanje znotraj prebavnega trakta zaradi olajševalnih okoliščin (npr. protimikrobne odpornosti ali polimikrobnih okužb).
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can be provided that the combination is in line with responsible use principles, combination products should be withdrawn.”
Slovenian: V zvezi s kombinacijami kolistina z drugimi protimikrobnimi sredstvi je v mnenju navedeno, da „je treba dovoljenja za promet s temi zdravili pregledati in kombinirana zdravila umakniti, razen v primeru primerne utemeljitve, da je kombinacija skladna z načeli odgovorne uporabe.“
English: Biofilms are protective layers around bacteria that are formed, for example, in the
Slovenian: Biofilmi so zaščitne plasti okrog bakterij, ki na primer nastajajo v prebavilih v obliki skupnosti sluzničnega biofilma
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.
Slovenian: Skupaj s pomanjkanjem kakovostnih kliničnih študij in drugih verodostojnih dokazov, ki bi potrjevali dodano vrednost kombiniranih zdravil s kolistinom v primerjavi z monoterapijo, ter pomanjkanjem skladnosti z načeli preudarne uporabe in smernico CVMP o farmacevtskih proizvodih s fiksno kombinacijo (EMEA/CVMP/83804/2005) to privede do zaključka, da za uporabo kombiniranih zdravil s kolistinom v veterinarski medicini ni veljavne utemeljitve.
English: Most clinical studies provided in this Article 35 referral procedure demonstrated that monotherapy products shared the same efficacy as colistin combination products.
Slovenian: V večini kliničnih študij, predloženih v okviru tega napotitvenega postopka v skladu s členom 35, so dokazali, da so zdravila za monoterapijo enako učinkovita kot kombinirana zdravila s kolistinom.
English: In veterinary medicine, it is used typically as the sulphate salt for oral preparations and as the methanesulphonate for parenteral administration.
Slovenian: V veterinarski medicini se praviloma uporablja v obliki sulfatne soli za peroralne pripravke in v obliki metansulfonata za parenteralno dajanje.
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.
Slovenian: Koncepti sinergije kombinacij s kolistinom so pomembnejši v humani medicini, ker se majhni odmerki kolistina injicirajo parenteralno skupaj z drugimi protimikrobnimi sredstvi, da se prepreči toksičnost.
English: Luxembourg VETOQUINOL Magny Vernois 70200 Lure
Slovenian: Luksemburg VETOQUINOL Magny Vernois 70200 Lure
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.
Slovenian: Ob upoštevanju precejšnjega števila zdravil, ki vsebujejo kolistin in so odobrena v EU, so menili, da je treba pri reviziji povzetka glavnih značilnosti zdravil, ki vsebujejo kolistin, uporabiti postopni pristop na podlagi tveganja.
English: Since the discovery in China, MCR-1 plasmid-mediated colistin resistance has been reported in a number of countries worldwide.
Slovenian: Od odkritja na Kitajskem so o odpornosti proti kolistinu, ki se prenaša s plazmidi in jo kodira gen mcr-1, poročali v številnih državah po svetu.
English: Therefore, the CVMP concluded that no gastrointestinal indications could be supported for colistin combination products.
Slovenian: Zato je odbor CVMP zaključil, da pri kombiniranih zdravilih s kolistinom ni mogoče podpreti nobene gastrointestinalne indikacije.
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.
Slovenian: Okužba prebavil, ki jo povzroča E. coli (kolibaciloza), ni priznana klinična bolezen pri žrebetih ali odraslih konjih, in podatki v podporo uporabi kolistina pri žrebetih niso bili predloženi, zato je treba to tarčno vrsto izločiti.
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.
Slovenian: Pojavili pa so se pomisleki, ali so gastrointestinalne indikacije kombiniranih zdravil s kolistinom utemeljene, kadar bi bilo preudarneje uporabiti zdravilo za monoterapijo.
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.
Slovenian: Glede na to, da je kolistin v humani medicini nedavno postal kritično pomemben, je uporabo v veterinarski medicini mogoče utemeljiti le z načeli preudarne uporabe, kar ne velja za kombinirana zdravila s kolistinom pri negastrointestinalnih indikacijah.
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.
Slovenian: Trenutna znanstvena literatura ne podpira uporabe kombiniranih zdravil s kolistinom pri žrebetih, saj lahko poruši ravnovesje prebavne mikroflore, kar privede do splošno priznanega smrtnega kolitisa, povezanega s protimikrobnim zdravljenjem, praviloma povezanega z bakterijo Clostridium difficile.
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.
Slovenian: Negastrointestinalne indikacije veljajo za nepotrebno uporabo kolistina, saj učinkovina ne prispeva k terapevtskemu učinku v drugih organih, okuženih z bakterijami.
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
Slovenian: Vendar so te študije in vitro nezanesljive, saj je glavna težava pri uporabi metod za določanje občutljivosti in vitro pri ugotavljanju učinkovitosti kombinacij s kolistinom proti bakterijam ta, da je natančnost različnih razpoložljivih tehnik, kot so mikro razredčevanje v bujonu, razredčevanje na agarju in Etest, zaradi kationskih lastnosti kolistina vprašljiva
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.
Slovenian: Kot je že bilo omenjeno, to za kombinirana zdravila s kolistinom ni klinično pomembno, saj se kolistin ne absorbira iz prebavnega trakta in torej nikoli ne sodeluje pri boju proti polimikrobnim okužbam v drugih ciljnih tkivih.
English: Colistin is a cationic, multicomponent lipopeptide antibacterial agent produced by cultures of Bacillus polymyxa var. colistinus.
Slovenian: Kolistin je kationsko, večkomponentno, lipopeptidno protibakterijsko sredstvo, ki ga proizvajajo kulture bakterij Bacillus polymyxa var. colistinus.
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.
Slovenian: številu dovoljenj za promet z zdravilom na farmacevtsko obliko/pot uporabe in vrstah uporabe so bila kot prednostna določena zdravila, ki vsebujejo samo kolistin in se dajejo peroralno (skupinsko zdravljenje).
English: Gastrointestinal infection caused by E. coli (colibacillosis) is not a recognised clinical disease in foals or adult horses.
Slovenian: Okužba prebavil, ki jo povzroča E. coli (kolibaciloza), ni priznana klinična bolezen pri žrebetih in odraslih konjih.
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).
Slovenian: Velika večina porabe polimiksinov pri živalih za proizvodnjo živil predstavlja kolistin za peroralno dajanje v raznolikih formulacijah (npr. v obliki predmešanice, praška, peroralnih raztopin).
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;
Slovenian: • odbor CVMP je menil, da tudi omejena uporaba kombiniranih zdravil s kolistinom pomeni nepotrebno uporabo kolistina in lahko potencialno prispeva k razvoju protimikrobne odpornosti;
English: Additionally, pharmacovigilance data have revealed no reports of lack of efficacy for colistin combination products.
Slovenian: Poleg tega v okviru farmakovigilančnih podatkov ni poročil o neučinkovitosti kombiniranih zdravil s kolistinom.
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.
Slovenian: V navedenem napotitvenem postopku v skladu s členom 35 (EMEA/V/A/106) za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin kot edino zdravilno učinkovino, za peroralno dajanje vrstam za proizvodnjo živil, je odbor CVMP prišel do določenih zaključkov (ki so opisani v nadaljevanju) o nekaterih indikacijah, odmerkih in ciljnih vrstah, ki bodo veljali tudi za kombinirana zdravila s kolistinom.
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.
Slovenian: Predložene niso bile nobene klinične študije ali utemeljitve za premajhno odmerjanje, ki zaradi spodbujanja bakterij, odpornih proti kolistinu, lahko pomeni tveganje za javno zdravje.
English: Sales of combination products with colistin represented less than 10% of the overall sales of colistin (ESVAC, unpublished data).
Slovenian: Prodaja kombiniranih zdravil s kolistinom je znašala manj kot 10 % skupne prodaje kolistina (evropski sistem za nadzor rabe protimikrobnih sredstev v veterinarski medicini (EVSAC), neobjavljeni podatki).
English: Gyógyszergyártó Kft. Ottó u. 14
Slovenian: Madžarska Lavet Gyógyszergyártó Kft. Ottó u. 14
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.
Slovenian: To še posebej zadeva določena kombinirana zdravila s kolistinom (npr. kolistin in neomicin ali kolistin in oksitetraciklin), pri katerih se nobena zdravilna učinkovina ne absorbira, zdravila pa so trenutno še vedno odobrena za indikacije zunaj prebavnega trakta.
English: with elevated MICs to colistin could constitute a risk to public health.
Slovenian: Vrste rodu Salmonella s povišanimi MIK za kolistin bi lahko pomenile tveganje za javno zdravje.
English: Doxal Italia S.p.a. largo Donegani 2 20121 - Milano Italy
Slovenian: largo Donegani 2 20121 - Milano Italy
English: Centro Empresarial da Rainha, Lote 27 2050-501 Vila Nova da Rainha Portugal
Slovenian: 2050-501 Vila Nova da Rainha
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
Slovenian: , je zdravnike prisilil v ponovno uvedbo toksičnega sistemskega zdravljenja s kolistinom v obliki manj toksičnega neaktivnega predzdravila, kolistinijevega metansulfonata, kot protimikrobnega sredstva zadnje možnosti pri okužbah z bakterijami, ki so pogosto vzrok bolnišničnih okužb
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.
Slovenian: Sočasne bolezni prebavil, povezane z E. coli (npr. septikemija), so imetniki dovoljenj za promet z zdravilom prepoznali kot zaplete prvotne bolezni prebavil bodisi zaradi neposrednega sistemskega širjenja bodisi zaradi imunosupresije.
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.”
Slovenian: V omenjenem sklepu Komisije je navedeno, da se bodo skladno z dogovorjenim postopnim pristopom „v naslednjem koraku po zaključku tega napotitvenega postopka lahko obravnavale kombinacije kolistina z drugim protimikrobnim sredstvom in neperoralno dajanje zdravil, ki vsebujejo kolistin.“
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.
Slovenian: V trenutnem napotitvenem postopku v skladu s členom 35 je bilo najdenih več kombiniranih zdravil za uporabo v veterinarski medicini s kolistinom, pri katerih je odmerek kolistina manjši od 50 000 i.e. na kg telesne mase.
English: In production animals, stresses in neonates and such related to weaning lead to dysbacteriosis and E. coli diarrhoea, which appear clinically similar.
Slovenian: Pri proizvodnih živalih stres pri novorojenih živalih in stres, povezan z odstavitvijo, povzroči disbakteriozo in drisko, ki jo povzroča E. coli, ki sta klinično podobni.
English: In conclusion, colistin combination products are intended to address different clinical needs to monotherapy products.
Slovenian: Kombinirana zdravila s kolistinom so torej namenjena obravnavi drugačnih kliničnih potreb kot zdravila za monoterapijo.
English: The same considerations taken for the colistin monotherapy products also apply to products containing colistin in combination with other antimicrobial substances.
Slovenian: Enaki premisleki kot za monoterapevtska zdravila s kolistinom veljajo tudi za zdravila, ki vsebujejo kolistin v kombinaciji z drugimi protimikrobnimi sredstvi.
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.
Slovenian: Kot posledica napotitvenega postopka v skladu s členom 35 za zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin kot edino zdravilno učinkovino (EMEA/V/A/106), kolistin zaradi negativne ocene razmerja med tveganji in koristmi ni več priporočen za zdravljenje okužb prebavil, ki jih povzročajo vrste rodu Salmonella.
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.
Slovenian: Zaradi obnovljene uporabe kolistina v humani medicini, zlasti kot zadnje terapevtske možnosti za zdravljenje okužb, ki jih povzročajo večkratno odporni (MDR), izredno odporni (XDR) in panrezistentni (PDR), laktozo fermentirajoči in nefermentirajoči po Gramu negativni bacili, vključno s Pseudomonas aeruginosa in Acinetobacter baumannii, pri nadaljnji veterinarski uporabi te učinkovine obstajajo morebitni pomisleki v zvezi z javnim zdravjem.
English: A recent paper identified another risk of colistin products and Salmonella spp.
Slovenian: V nedavno objavljenem članku so ugotovili še eno tveganje zdravil s kolistinom pri vrstah rodu Salmonella.
English: In addition, colistin lacks therapeutic activity against inherently resistant species, including the genera Serratia, Stenotrophomonas and Proteus
Slovenian: Poleg tega kolistin ni terapevtsko učinkovit proti inherentno odpornim vrstam, vključno z rodovi Serratia, Stenotrophomonas inProteus
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.
Slovenian: Ta pojav gena mcr-1 pri živalih in z ljudmi povezanih bakterijah napoveduje vdor s plazmidi prenosljive odpornosti v zadnjo skupino antibiotikov, polimiksine.
English: Thus, it is unknown if a combination product provides an added value over a monotherapy product for this indication.
Slovenian: Zato ni znano, ali imajo kombinirana zdravila pri tej indikaciji dodano vrednost v primerjavi z zdravili za monoterapijo.
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.
Slovenian: so dokazali stalno zelo nizko raven odpornosti proti kolistinu pri živalih za proizvodnjo živil in zmanjšano odpornost proti več drugim protimikrobnim sredstvom, ki se uporabljajo v kombiniranih zdravilih s kolistinom, kljub večletni široki uporabi teh zdravil v EU.
English: Colibacillosis is not a term used in equine medicine, but a term used for pigs, poultry and ruminants.
Slovenian: Izraz kolibaciloza se ne uporablja v medicini konj, pač pa pri prašičih, perutnini in prežvekovalcih.
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.
Slovenian: Kolibaciloza je opredeljena kot okužba debelega črevesa, ki jo povzročajo bakterije družine Enterobacteriaceae, zlasti E. coli, kaže pa se kot bolezen, praviloma v obliki driske in v drugih oblikah pri perutnini.
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;
Slovenian: • odbor CVMP je zaključil, da je ocena razmerja med tveganji in koristmi za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin v kombinaciji z drugimi protimikrobnimi sredstvi, za peroralno dajanje, negativna in da ta zdravila lahko pomenijo potencialno tveganje za zdravje ljudi;
English: E. coli septicaemia is a recognised disease in neonatal foals that can be sometimes be expressed as diarrhoea, among other symptoms.
Slovenian: Septikemija z E. coli je priznana bolezen pri novorojenih žrebetih, ki se včasih lahko kaže v obliki driske, ima pa tudi druge simptome.
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;
Slovenian: • odbor CVMP je menil, da imetniki dovoljenj za promet z zdravilom niso predložili prepričljivih podatkov v smislu kliničnih preskušanj ali drugih znanstveno sprejemljivih študij glede kliničnih scenarijev, pri katerih so kombinirana zdravila s kolistinom nujna za živali za proizvodnjo živil v EU v primerjavi z zdravili za monoterapijo;
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.
Slovenian: O teh vprašanjih imetniki dovoljenj za promet z zdravilom niso predložili prepričljivih podatkov v smislu kliničnih preskušanj ali drugih znanstveno sprejemljivih študij glede kliničnih scenarijev, pri katerih so kombinirana zdravila s kolistinom nujna za živali za proizvodnjo živil v EU v primerjavi z zdravili za monoterapijo.
English: Via Affarosa, 4 42010 - Rio Saliceto Italy
Slovenian: 42010 - Rio Saliceto Italy
English: Lithuania COOPHAVET S.A.S.
Slovenian: Bolgarija COOPHAVET S.A.S.