FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no data available that would allow the Committee to estimate the risk for rabbits alone but it seems adequate to allow for the extrapolation of information from poultry and pigs.
Slovenian: Podatkov, ki bi odboru omogočili oceno tveganja samo za kunce, ni, vendar se zdi ustrezno dovoliti ekstrapolacijo podatkov za perutnino in prašiče.
English: It is very important that those antimicrobials are used in veterinary and human medicine according to responsible use principles to safeguard the efficacy of these substances and minimise the development of and dissemination of antimicrobial resistance.
Slovenian: Zelo pomembno je, da se navedena protimikrobna zdravila uporabljajo v veterinarski in humani medicini v skladu z načeli odgovorne uporabe za zaščito učinkovitosti teh snovi ter zmanjšanje razvoja in širjenja protimikrobne odpornosti.
English: In addition this process seems to be immediate which means that the overall time during which faeces of rabbits are exposed to enrofloxacin during treatment is not significantly higher than without the coprophagy practice.
Slovenian: Poleg tega se zdi, da je ta proces takojšen, kar pomeni, da skupni čas, v katerem so kunčji iztrebki med zdravljenjem izpostavljeni enrofloksacinu, ni bistveno daljši od časa izpostavljenosti brez prakse koprofagije.
English: Fluoroquinolones are also authorised for use in cattle, pigs and poultry.
Slovenian: Fluorokinoloni se lahko uporabljajo tudi pri govedu, prašičih in perutnini.
English: It should also be noted that coprophagy involves the ingestion of the own rabbit faeces and that there are no data to assess if this would have any impact on increase of resistance.
Slovenian: Opozoriti je treba tudi, da koprofagija vključuje zaužitje lastnih kunčjih iztrebkov in da niso na voljo nobeni podatki za oceno, ali to vpliva na povečanje odpornosti.
English: Taking into account the above reasoning the Committee considered that withdrawing or not authorising the use of these products in rabbit was considered not proportionate as this would create a negative impact on the availability of tools to treat respiratory diseases in this minor species, in cases when other antibiotics cannot be used or would not be sufficiently effective.
Slovenian: Odbor je ob upoštevanju zgornje utemeljitve menil, da bi bila ukinitev ali prepoved uporabe teh zdravil pri kuncih nesorazmerna, saj bi to negativno vplivalo na razpoložljivost orodij za zdravljenje bolezni dihal pri tej manj pomembni vrsti, kadar drugih antibiotikov ni mogoče uporabljati ali ti ne bi bili dovolj učinkoviti.
English: Restrictions on availability of antimicrobials for rabbits may cause animal health and welfare concerns.
Slovenian: Omejitev razpoložljivosti protimikrobnih zdravil pri kuncih lahko povzroči skrbi v zvezi z zdravjem živali in njihovim dobrim počutjem.
English: Grounds for maintaining the marketing authorisations
Slovenian: Razlogi za ohranitev dovoljenj za promet z zdravilom
English: The use of fluoroquinolones in rabbits may therefore have a higher risk on development of antimicrobial resistance, however this risk is theoretical.
Slovenian: Uporaba fluorokinolonov pri kuncih lahko zato pomeni večje tveganje za razvoj protimikrobne odpornosti, vendar je to tveganje teoretično.
English: However, data indicates that in the long run treatment could result in a decrease of efficacy of the treatment of the disease in rabbits and thus it is important that use is limited to cases where it is clearly needed and should be combined with good husbandry practices.
Slovenian: Vendar podatki kažejo, da bi lahko bila manjša učinkovitost zdravljenja bolezni pri kuncih dolgoročna posledica zdravljenja, zato ga je treba omejiti na primere, kjer je jasno potrebno, in ga izvajati skupaj z dobrimi živinorejskimi praksami.
English: Therefore, there are no data available to characterise the risk to public health specifically linked to intake of rabbit meat or contact with food producing rabbits.
Slovenian: Zato niso na voljo podatki za opredelitev tveganja za javno zdravje, ki je povezano zlasti z vnosom kunčjega mesa ali stikom s kunci za proizvodnjo živil.
English: Rabbits are raised in continuous systems where resistant bacteria might be persistent over time, however the overall risk would remain low due to the low consumption of rabbit meat.
Slovenian: Kunce vzrejajo v neprekinjenih sistemih, kjer so lahko ves čas prisotne odporne bakterije, vendar bi splošno tveganje zaradi nizke porabe kunčjega mesa ostalo nizko.
English: The evaluation of the risk related antimicrobial resistance has to consider both effects; on the target animal species and in humans.
Slovenian: V oceni protimikrobne odpornosti, povezane s tveganjem, je treba upoštevati oba učinka, in sicer na ciljno živalsko vrsto in na ljudi.
English: Enrofloxacin is for veterinary use only.
Slovenian: Enrofloksacin je namenjen samo uporabi v veterinarski medicini.
English: The practice of coprophagy (consumption of faeces) that is part of rabbits behaviour/physiology may hypothetically have an impact on development of antimicrobial resistance.
Slovenian: Koprofagija (uživanje iztrebkov), ki je del vedenja/fiziologije kuncev, lahko hipotetično vpliva na razvoj protimikrobne odpornosti.
English: Resistance transmission has not been studied specifically in rabbits.
Slovenian: Prenos odpornosti pri kuncih se ni posebej preučeval.
English: Data on susceptibility of enrofloxacin from a study conducted in Spain in 2005 showed a MIC90 of 0.06 µg/ml.
Slovenian: Podatki o občutljivosti za enrofloksacin iz študije, opravljene leta 2005 v Španiji, so pokazali, da je MIC90 0,06 µg/ml.
English: It is anticipated that the risk on individual level might be increased for rabbit as compared to other species.
Slovenian: Pričakuje se, da se bo lahko tveganje na individualni ravni pri kuncih povečalo v primerjavi z drugimi živalskimi vrstami.
English: The antimicrobial prudent use recommendations and warnings that are included in the product information are as follows:
Slovenian: Priporočila za preudarno uporabo protimikrobnih zdravil in opozorila o taki uporabi, ki so vključena v informacije o zdravilu, so:
English: Regarding the second risk, spread of resistant zoonotic bacteria and resistance genes via food, this is a well characterised risk for which CVMP in November 2006 recommended risk mitigation measures7.
Slovenian: Drugo navedeno tveganje, širitev odpornih zoonotskih bakterij in genov za odpornost s hrano, je dobro opredeljeno, zato je odbor CVMP novembra 2006 v zvezi z njim priporočil ukrepe za ublažitev tveganja7.
English: In another study carried out in Spain in 2011 to address the evolution of the level of resistances the MIC50 and the MIC90 of the P. multocida strains examined were 0.125 and 0.380 µg/ml, respectively.
Slovenian: V drugi študiji, ki je bila izvedena leta 2011 v Španiji za preučitev evolucije stopnje odpornosti, sta bila MIC50 in MIC90 preučevanih sevov P. multocida 0,125 oziroma 0,380 µg/ml.
English: In relation to the first risk, the use of fluoroquinolones is identified as a risk factor for spread of MRSA but this would be an issue mainly in case of high prevalence of MRSA in animals and/or close contact between animals and humans.
Slovenian: Glede na prvo tveganje je uporaba fluorokinolonov opredeljena kot dejavnik tveganja za širjenje MRSE, kar bi bilo problematično večinoma v primerih velike razširjenosti MRSE pri živalih ter/ali ob tesnem stiku med živalmi in ljudmi.
English: France considered that these resistances would possibly be directly or indirectly transmitted to humans and may represent a potential serious risk to public health as enrofloxacin belongs to the fluoroquinolones family which is considered a highly critical class of antimicrobials for human health.
Slovenian: Menila je tudi, da bi se lahko taka odpornost neposredno ali posredno prenesla na ljudi in bi lahko pomenila morebitno resno tveganje za javno zdravje, saj enrofloksacin spada v družino fluorokinolonov, ki je zelo pomemben razred protimikrobnih zdravil za človekovo zdravje.
English: • no additional risk management or mitigation measures nor prohibition of enrofloxacin in rabbits was considered proportionate;
Slovenian: • se je štelo, da sprejetje dodatnih ukrepov za obvladovanje ali zmanjšanje tveganja in prepoved uporabe enrofloksacina pri kuncih nista sorazmerni;
English: Risk to public health due to spread of resistant bacteria from treated animals Data from the RESAPATH 2009 and 2010 annual reports (French surveillance network for antimicrobial resistance in pathogenic bacteria of animal origin) were provided.
Slovenian: Tveganje za javno zdravje zaradi širjenja odpornih bakterij z zdravljenih živali Predloženi so bili podatki letnih poročil mreže RESAPATH (francoske mreže za spremljanje odpornosti patogenih bakterij živalskega izvora na protimikrobna zdravila) za leti 2009 in 2010.
English: In the absence of specific data concerning transmission of resistant bacteria from rabbits to humans, the risk analysis from other animal species where enrofloxacin is used (poultry and pigs) is extrapolated to rabbits.
Slovenian: Ker ni posebnih podatkov glede prenosa odpornih bakterij s kuncev na človeka, je analiza tveganja za druge živalske vrste, pri katerih se uporablja enrofloksacin (perutnina in prašiči), ekstrapolirana za kunce.
English: This observed decrease of susceptibility could either be explained by methodological factors, or it could reflect a true emergence of decreased susceptibility, that could be related to the use of enrofloxacin in rabbits or other animal species.
Slovenian: To opaženo zmanjšanje občutljivosti je mogoče razložiti z metodološkimi dejavniki, lahko pa je tudi posledica dejanskega pojava zmanjšane občutljivosti, ki je morda povezana z uporabo enrofloksacina pri kuncih ali drugih živalskih vrstah.
English: The transfer of resistant bacteria from animals to humans may occur via consumption of meat carrying enteric zoonotic bacteria e.g. E. coli or by direct contact with animals, e.g. Staph.
Slovenian: Prenos odpornih bakterij z živali na ljudi se lahko zgodi z zaužitjem mesa, ki vsebuje enterične zoonotske bakterije, na primer E. Coli, ali z neposrednim stikom z živalmi, na primer Staph.
English: The prudent use recommendations and warnings that are listed in the product information for these products should be strictly followed and the products should not be used as a first line treatment.
Slovenian: Priporočila za preudarno uporabo in opozorila o taki uporabi, ki so navedena v informacijah o zdravilu za zadevna zdravila, je treba strogo upoštevati, saj se ta zdravila ne smejo uporabljati za začetno zdravljenje.
English: SP VETERINARIA Ctra.Reus-Vinyols, Km, 43330 Ruidoms SPAIN
Slovenian: SP VETERINARIA Ctra.Reus-Vinyols, Km, 43330 Ruidoms ŠPANIJA
English: On 30 September 2011, France initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for the veterinary medicinal product HIPRALONA ENRO-S and its generics indicated for use in rabbits.
Slovenian: Francija je 30. septembra 2011 skladno s členom 35 Direktive 2001/82/ES, kakor je bila spremenjena, sprožila postopek napotitve za zdravilo HIPRALONA ENRO-S za uporabo v veterinarski medicini in njegova generična zdravila za uporabo pri kuncih.
English: The enrofloxacin is an antimicrobial belonging to the class of fluoroquinolones, which are listed by the WHO as a critically important class of antimicrobials for human health (Critically important antimicrobials for human medicine, WHO/AGISAR, Copenhagen, 2009).
Slovenian: Enrofloksacin je protimikrobno zdravilo iz razreda fluorokinolonov, ki jih SZO uvršča v zelo pomemben razred protimikrobnih zdravil za človekovo zdravje (protimikrobna sredstva, ki so bistvenega pomena za humano medicino, SZO/AGISAR, København, 2009).
English: There are two risks for public health identified with the use of enrofloxacin in rabbits: (i) the risk for spread of methicillin resistant Staphylococcus aureus (MRSA) from rabbits to people in contact with these animals and (ii) the risk of spread of resistant zoonotic bacteria and transmissible resistance genes via food, e.g. Salmonella and E. coli.
Slovenian: Pri uporabi enrofloksacina pri kuncih sta bili opredeljeni dve tveganji za javno zdravje: (i) tveganje za širjenje proti meticilinu odpornega Staphylococcus aureus (MRSA) s kuncev na ljudi ob stiku z živalmi in (ii) tveganje za širjenje odpornih zoonotskih bakterij in prenosljivih genov za odpornost s hrano, na primer salmonele in E. coli.
English: From the route of administration it can be concluded that the risk of rabbit treatment would be similar to that of poultry.
Slovenian: Na podlagi načina uporabe zdravila je mogoče sklepati, da bo tveganje pri zdravljenju kuncev podobno tveganju pri zdravljenju perutnine.
English: The safety and efficacy of the product have been demonstrated in a well conducted GCP compliant trial that fulfils the requirements of Directive 2001/82/EC and the relevant guidelines using a dose of 10 mg/kg bw for 5 consecutive days.
Slovenian: Varnost in učinkovitost zdravila sta bili dokazani v preskušanju, ustrezno izvedenem v skladu z dobro klinično prakso, zahtevami Direktive 2001/82/ES in ustreznimi smernicami, pri čemer je bil uporabljen odmerek 10 mg/kg telesne mase 5 zaporednih dni.
English: • on the basis of the available data on antimicrobial resistance, and taking into account the very limited data on resistance that are available in rabbit production, the CVMP considered that the use of the concerned products in rabbits would not represent a higher risk for public health when compared with use in other animals species;
Slovenian: • je odbor CVMP na podlagi razpoložljivih podatkov o protimikrobni odpornosti in ob upoštevanju zelo omejenih podatkov o odpornosti, ki so na voljo za rejo kuncev, menil, da uporaba zadevnih zdravil pri kuncih ne pomeni večjega tveganja za javno zdravje v primerjavi z uporabo pri drugih živalskih vrstah;
English: The products are authorised for use in the target species chickens, turkeys and rabbits.
Slovenian: Zdravila se lahko uporabljajo pri ciljnih vrstah piščancev, puranov in kuncev.
English: • Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Slovenian: • fluorokinolone je treba uporabljati le za zdravljenje kliničnih stanj, pri katerih je bil odziv na druge razrede protimikrobnih zdravil slab ali se v zvezi z njimi pričakuje, da bo slab;
English: A less well characterised and possibly slightly higher risk as compared to other species could be acceptable in case of a minor species.
Slovenian: Za manj pomembne vrste bi lahko bilo v primerjavi z drugimi živalskimi vrstami sprejemljivo slabše opredeljeno in nekoliko večje tveganje.
English: The development of antimicrobial resistance is a risk for target animal species resulting in lack of efficacious treatment and for humans by transferring resistant bacteria from animals to humans.
Slovenian: Razvoj protimikrobne odpornosti je tveganje za ciljno živalsko vrsto, kar povzroči nezadostno učinkovito zdravljenje, in ljudi, saj se odporne bakterije z živali prenašajo na ljudi.
English: Regarding S. aureus, 89% (2009) and 82% (2010) of the bacterial isolates were susceptible to enrofloxacin.
Slovenian: Pri S. aureus je bilo za enrofloksacin občutljivih 89 % (2009) in 82 % (2010) bakterijskih izolatov.
English: Furthermore, several studies were presented in order to address the susceptibility of different field strains of P. multocida to enrofloxacin.
Slovenian: Poleg tega je bilo predloženih več študij, ki so obravnavale občutljivost različnih sevov P. multocida za enrofloksacin.
English: Risk to animals health
Slovenian: Tveganje za zdravje živali
English: Taking into account all available data it was considered that the use of HIPRALONA ENRO-S and its generics in rabbits would represent a comparable or lower risk for public health compared to the use of enrofloxacin in other animal species (e.g. poultry or pigs).
Slovenian: Na podlagi vseh razpoložljivih podatkov se je štelo, da uporaba zdravila HIPRALONA ENRO-S in njegovih generičnih zdravil pri kuncih ne pomeni primerljivega ali manjšega tveganja za javno zdravje v primerjavi z uporabo enrofloksacina pri drugih živalskih vrstah (npr. perutnini ali prašičih).
English: The efficacy of the product has been demonstrated in a well conducted GCP compliant trial.
Slovenian: Učinkovitost zdravila je bila dokazana v preskušanju, ki je bilo ustrezno izvedeno v skladu z dobro klinično prakso.
English: The pharmaceutical form is an oral solution administered via the drinking water.
Slovenian: Farmacevtska oblika je peroralna raztopina, ki se daje s pitno vodo.
English: The data from published literature (RESAPATH annual reports) show that the sensitivity of P. multocida strains to enrofloxacin in rabbits was high (100% and 99% in 2009 and 2010, respectively).
Slovenian: Podatki iz objavljene literature (letna poročila mreže RESAPATH) kažejo, da je občutljivost sevov P. multocida za enrofloksacin pri kuncih velika (100 % leta 2009 in 99 % leta 2010).
English: With regard to intensively reared rabbits, the risk is likely to be minor in comparison with the other species due to the size of rabbits production and no measures have been deemed necessary to minimise the risk for spread of MRSA from those.
Slovenian: Pri kuncih iz intenzivne reje je tveganje zaradi obsega reje kuncev verjetno majhno v primerjavi z drugimi vrstami, zato se je štelo, da niso potrebni nobeni ukrepi za zmanjševanje tveganja za širjenje MRSE pri teh živalih.
English: 1 CVMP Public statement on the use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
Slovenian: 1 CVMP - Javno sporočilo o uporabi (fluoro)kinolonov pri živalih za proizvodnjo živil v Evropski uniji: razvoj odpornosti in vpliv na zdravje ljudi in živali (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
English: It is acknowledged that the limited availability of authorised veterinary medicinal products containing first line antimicrobials as active substance make it difficult to comply with the responsible use recommendations for fluoroquinolones and the recommendation that it is desirable that antimicrobials
Slovenian: Znano je, da je zaradi omejene razpoložljivosti odobrenih zdravil za uporabo v veterinarski medicini, ki kot zdravilno učinkovino vsebujejo protimikrobne učinkovine prve izbire, težavno delovati skladno s priporočili za odgovorno uporabo fluorokinolonov in priporočilom, naj se namesto fluorokinolonov kot zdravljenje
English: Nutrição e Comércio de Produtos Químicos
Slovenian: Portugalska Prodivet-Zn, Nutrição e Comércio de Produtos Químicos
English: HIPRALONA ENRO-S and its generics were involved in the referral under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species (EMEA/V/A/049) and the adequate prudent use warnings were recommended for these products.
Slovenian: Zdravilo HIPRALONA ENRO-S in njegova generična zdravila so bila predmet postopka napotitve iz člena 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, namenjena uporabi pri živalskih vrstah za proizvodnjo živil (EMEA/V/A/049), in priporočena so bila ustrezna opozorila za preudarno uporabo teh zdravil.
English: 08028 - BARCELONA SPAIN
Slovenian: 08028 - BARCELONA ŠPANIJA
English: In intensive reared rabbits the treatment will be of the flock and not individual animals which may increase the risk of development of resistant bacteria, this is similar to poultry production where flocks of animals are treated.
Slovenian: Pri kuncih iz intenzivne reje se zdravi cela kletka in ne posamezne živali, kar lahko poveča tveganje za razvoj odpornih bakterij; podobno je pri reji perutnine, kjer se zdravijo jate živali.
English: From the RESAPATH annual reports, the highest susceptibility levels to enrofloxacin in E. coli in rabbits were 90% (2009) and 85% (2010).
Slovenian: V letnih poročilih mreže RESAPATH sta najvišji ravni občutljivosti E. coli za enrofloksacin pri kuncih znašali 90 % (2009) in 85 % (2010).
English: The concerns raised by France were that the use of HIPRALONA ENRO-S and its generics in rabbit production would increase Escherichia coli and Staphylococcus aureus resistance to enrofloxacin.
Slovenian: Francija je izrazila zaskrbljenost, da bi lahko uporaba zdravila HIPRALONA ENRO-S in njegovih generičnih zdravil pri kunčjereji povečala odpornost Escherichia coli in Staphylococcus aureus na enrofloksacin.
English: • Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Slovenian: • uporaba zdravila, ki ni v skladu z navodili iz povzetka glavnih značilnosti zdravila, lahko poveča razširjenost bakterij, ki so odporne na fluorokinolone, in lahko zaradi možnosti navzkrižne odpornosti zmanjša učinkovitost zdravljenja z drugimi kinoloni.
English: • prudent use warnings for fluoroquinolones were recommended by the CVMP for the products concerned and should be strictly followed;
Slovenian: • je odbor CVMP za vsa zadevna zdravila priporočil opozorila o preudarni uporabi fluorokinolonov, ki jih je treba strogo upoštevati;
English: The dosage is 10 mg enrofloxacin per kg bodyweight (bw) during 5 days.
Slovenian: Odmerek je 10 mg enrofloksacina na kilogram telesne mase v 5 dneh.
English: The conclusion of a comparative study of plasma levels of enrofloxacin and its metabolite ciprofloxacin during treatment with the product at doses equivalent to 5 and 10 mg/kg bw of enrofloxacin administered in drinking water for 5 consecutive days was that the effective dose regimen of enrofloxacin for the treatment of respiratory infections caused by P. multocida in rabbits is 10 mg/kg bw.
Slovenian: Ugotovitev primerjalne študije ravni enrofloksacina in njegovega metabolita ciprofloksacina v plazmi med zdravljenjem z zdravilom v odmerkih 5 in 10 mg enrofloksacina/kg telesne mase, ki so se 5 zaporednih dni dajali s pitno vodo, je bila, da je učinkoviti odmerek enrofloksacina za zdravljenje okužb dihal pri kuncih, ki jih povzroča P. multocida, 10 mg/kg telesne mase.
English: The CVMP was requested to give its opinion as to whether the benefit-risk ratio for HIPRALONA ENRO-S and its generics is positive when the products are administered to rabbits and whether the introduction of such highly critical antibiotics in a food production species, used via oral route, is in line with the current recommendations to implement prudent use of antimicrobials (EMEA/CVMP/SAGAM/184651/2005)1.
Slovenian: CVMP je bil zaprošen za mnenje o tem, ali je razmerje med koristmi in tveganji zdravila HIPRALONA ENRO-S in njegovih generičnih zdravil pozitivno, kadar se ta dajejo kuncem, ter ali je uvajanje takih bistveno pomembnih antibiotikov pri živalskih vrstah za proizvodnjo živil po peroralni poti skladno s trenutnimi priporočili za preudarno uporabo protimikrobnih zdravil (EMEA/CVMP/SAGAM/184651/2005)1.
English: Overall benefit-risk
Slovenian: Splošno razmerje med koristmi in tveganji
English: Overall summary of the scientific evaluation of HIPRALONA ENRO-S and its generics intended for use in rabbits (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila HIPRALONA ENRO-S in njegovih generičnih zdravil, namenjenih uporabi pri kuncih (glejte Prilogo I)
English: HIPRALONA ENRO-S and its generics contain 100 mg enrofloxacin per ml oral solution for use in drinking water.
Slovenian: Zdravilo HIPRALONA ENRO-S in njegova generična zdravila vsebujejo 100 mg enrofloksacina na ml peroralne raztopine za uporabo v pitni vodi.