natgillin/translations-raw huggingface dataset:
and against some gram-negative bacteria such as E. coli.
in po gramu negativnim bakterijam, kot je E. coli.
A likely explanation to the mechanism of action of spectinomycin against respiratory E. coli is rather an indirect effect on the gut flora, leading to a reduction of the shedding into the environment.
Verjetnejša razlaga mehanizma delovanja spektinomicina proti respiratorni E. coli je posredni učinek na črevesno floro, zaradi česar se zmanjša izločanje v okolje.
The risk for possible in vitro resistant strains should be included in the product information.
Tveganje za potencialne seve, odporne in vitro, mora biti vključeno v informacije o zdravilu.
In E. coli the MIC distribution appears to be bimodal, with a significant number of strains showing high MIC values; this could partly correspond to natural (intrinsic) resistance.
Pri E. coli se porazdelitev MIK zdi bimodalna, z znatnim številom sevov, ki kažejo visoke vrednosti MIK; to bi lahko deloma ustrezalo naravni (intrinzični) odpornosti.
Where the following target species have already been approved, the wording below relating to the relevant species should be used:
Kadar je bila uporaba pri naslednjih ciljnih živalskih vrstah že odobrena, je treba v zvezi z zadevnimi živalskimi vrstami uporabiti spodnje besedilo:
These include notably, Escherichia coli, Salmonella spp., and Campylobacter spp.
Med njimi so predvsem Escherichia coli, Salmonella spp.
Lincomycin-Spectinomycin 1,1% "Animed Service"Pulver zum Eingeben für Schweine
Lincomycin-Spectinomycin 1,1% "Animed Service"Pulver zum Eingeben für Schweine prašek za dajanje v krmo
It was concluded that most Brachyspira isolates demonstrated in vitro resistance and that it could not be expected that oral tylosin would be sufficiently efficacious for the treatment of swine dysentery.
Zaključeno je bilo, da večina izolatov Brachyspira kaže odpornost in vitro in da ni pričakovati zadostne učinkovitosti peroralnega tilozina pri zdravljenju prašičje dizenterije.
It is generally considered that the resistance status against tylosin closely follows that for lincomycin because of cross-resistance (see e.g. the CVMP reflection paper (EMA/CVMP/SAGAM/741087/2009))
V splošnem velja, da je zaradi navzkrižne odpornosti stanje odpornosti proti tilozinu precej podobno stanju odpornosti proti linkomicinu (glejte npr. dokument o presoji odbora CVMP (EMA/CVMP/SAGAM/741087/2009))
It appears however that this represents a minority of strains; also, this is based on sparse data and on several estimations, and no firm clinical breakpoint has been established up until now.
Vendar se zdi, da so ti sevi v manjšini; poleg tega ti poskusi temeljijo na pomanjkljivih podatkih in več ocenah, do zdaj pa še niso bile določene trdne klinične mejne vrednosti.
The macrolide tylosin is closely related to lincosamides and binds to an overlapping ribosomal site.
Makrolid tilozin je tesno povezan z linkozamidi in se veže na prekrivajoče se mesto ribosoma.
No further data have been presented in the framework of this referral to support any indications in poultry species other than chickens.
V okviru te napotitve niso bili predstavljeni dodatni podatki v podporo kakršnim koli indikacijam pri vrstah perutnine, ki niso piščanci.
It appears that currently pleuromutilins still constitute an effective alternative for the treatment of the disease, although MIC increases, deemed as alarming, have been detected in several surveys (see CVMP reflection paper (EMA/CVMP/AWP/119489/2012))
Zdi se, da plevromutilini trenutno še vedno predstavljajo učinkovito alternativo za zdravljenje bolezni, čeprav so bila v več raziskavah (glejte dokument o presoji odbora CVMP (EMA/CVMP/AWP/119489/2012))
Pigs: To be completed nationally.
Prašiči: Podatke je treba dopolniti v posameznih državah.
Pleuromutilins also share with lincosamides overlapping binding sites at the ribosomal peptidyl transferase center, and multi-resistant strains (to pleuromutilins, macrolides and lincosamides) have arisen.
Plevromutilini si z linkozamidi delijo tudi prekrivajoča se mesta vezave na ribosomskem centru za peptidiltransferazo, pojavili pa so se tudi multirezistentni sevi (proti plevromutilinom, makrolidom in linkozamidom).
Subsequent to the outcome of the aforementioned Article 34 referral procedure for Linco-Spectin 100, Belgium considered that it is in the interest of the Union to promote effective and rational use of the lincomycin-spectinomycin combination in orally administered veterinary medicinal products, and thereby limit the risk of resistance development.
Belgija je po izidu omenjenega napotitvenega postopka v skladu s členom 34 za zdravilo Linco-Spectin 100 upoštevala, da je spodbujanje učinkovite in razumne rabe kombinacije linkomicina in spektinomicina pri zdravilih za peroralno dajanje v veterinarski medicini in s tem omejevanje tveganja za razvoj odpornosti v interesu Unije.
SPC warnings informing the user about that resistance status are not considered sufficient to mitigate that risk, notably because of the absence of interpretive criteria and standardised methods for susceptibility testing.
Opozorila v povzetku glavnih značilnosti zdravila, s katerimi je uporabnik obveščen o tem stanju odpornosti, pri zmanjšanju tega tveganja ne veljajo za zadostna, še posebej zaradi odsotnosti razlagalnih meril in standardiziranih metod za testiranje občutljivosti.
The mechanism by which spectinomycin administered orally acts on pathogens at the systemic level despite a poor absorption is not fully elucidated, and might rely partly on indirect effects on the gut flora.
Mehanizem, prek katerega peroralno dani spektinomicin kljub slabi absorpciji deluje na patogene na sistemski ravni, ni v celoti pojasnjen, deloma pa morda temelji na posrednih učinkih na črevesno floro.
In addition, spectinomycin is polar and does not readily cross membranes to distribute into the intracellular compartment.
Poleg tega je spektinomicin polaren in ne prehaja zlahka skozi membrane ter se ne porazdeli zlahka v notranjost celic.
The data available do not allow the establishment of a clear time pattern for the evolution of MICs.
Podatki, ki so na voljo, ne omogočajo določitve jasnega časovnega vzorca za razvoj minimalnih inhibicijskih koncentracij.
Spectinomycin is also active against Salmonella spp., and both compounds are active against Campylobacter spp.
Spektinomicin deluje tudi proti Salmonella spp., obe učinkovini pa delujeta proti Campylobacter spp.
It is known from the PK properties of spectinomycin that only negligible amounts are absorbed from the gut and that in any case, blood levels do not reach MIC levels.
Na podlagi farmakokinetičnih lastnosti spektinomicina je znano, da se iz črevesa absorbirajo samo zanemarljive količine in da ravni v krvi v nobenem primeru ne dosežejo koncentracij MIK.
CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf CVMP reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/AWP/119489/2012)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154734.pdf
CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf CVMP reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/AWP/119489/2012)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154734.pdf spektinomicina na kilogram telesne mase na dan s časom zdravljenja sedem dni v vodi za pitje, ki je bila odobrena v okviru napotitvenega postopka v skladu s členom 34 (EMEA/V/A/088) za zdravilo Linco-Spectin 100, upravičena.
Therefore, when considering the high in vitro resistance rate in B. hyodysenteriae, and to a lesser extent in possible associated pathogens, together with the limitations of the available clinical data, it appears that in the current situation the combination may remain effective only in a minority of field situations, and no well-established interpretive criterion or standardised test method exists which allows the user to predict efficacy against B. hyodysenteriae.
Ob upoštevanju visoke stopnje odpornosti in vitro pri B. hyodysenteriae in v manjšem obsegu pri potencialnih sorodnih patogenih ter ob hkratnem upoštevanju omejitev razpoložljivih kliničnih podatkov se zato zdi, da lahko v trenutnem položaju kombinacija ostane učinkovita le pri manjšem številu stanj na terenu in da ni dobro uveljavljenega razlagalnega merila ali standardizirane testne metode, ki bi uporabniku omogočala napovedovanje učinkovitosti proti B. hyodysenteriae.
The presence of the disease in the group must be established before the product is used.
Pred uporabo zdravila je treba ugotoviti prisotnost bolezni v skupini.
The CVMP considers that the obvious increase in MIC values in European B. hyodysenteriae isolates with regard to wild-type strains, impacts the benefit-risk assessment for the group of products under assessment since this is not taken into account in most available clinical efficacy studies which were conducted at the time of product development.
Odbor CVMP meni, da očitno povečanje vrednosti MIK v evropskih izolatih B. hyodysenteriae v zvezi s sevi divje vrste vpliva na oceno razmerja med tveganji in koristmi za skupino ocenjevanih zdravil, ker to v večini razpoložljivih študij o klinični učinkovitosti, ki so bile izvedene v času razvoja zdravila, ni bilo upoštevano.
Although that some disease outbreaks would still be treated with sufficient efficacy in the current field situation, the risks of treatment failure and delay of effective therapy by pleuromutilins, due to the high in vitro resistance rates and high uncertainty regarding the associated clinical outcome, are considered to outweigh the clinical benefit in a minority of field outbreaks.
Čeprav bodo pri trenutnem stanju na terenu nekateri izbruhi bolezni še vedno dovolj učinkovito zdravljeni, velja, da tveganja za neuspešno zdravljenje in zakasnitev učinkovitega zdravljenja s plevromutilini zaradi visokih stopenj odpornosti in vitro in negotovosti glede s tem povezanega kliničnega izida odtehtajo klinične koristi le pri manjšem številu izbruhov na terenu.
One monocentric study concerning in-feed use is presented, which shows a beneficial effect in case of porcine proliferative enteropathy, but this uses lincomycin alone at a high dose in comparison to those used in the combination.
Predstavljena je bila ena monocentrična študija v zvezi z uporabo v krmi, ki v primeru prašičje proliferativne enteropatije kaže koristen učinek, vendar je v njej, v primerjavi z odmerki, uporabljenimi v kombinaciji, uporabljen samo visok odmerek linkomicina.
It is considered that indications relating to swine dysentery caused by B. hyodyenteriae, and associated pathogens, are not sufficiently supported and that the use of the products in such conditions entails a risk of treatment failure, which, in addition, is linked to a risk of further resistance selection and co-selection.
Velja, da indikacije v zvezi s prašičjo dizenterijo, ki jo povzročajo B. hyodysenteriae in sorodni patogeni, niso dovolj podprte in da pri uporabi zdravil v takih pogojih obstaja tveganje za neuspešno zdravljenje, ki je poleg tega povezano s tveganjem za dodatno selekcijo in koselekcijo odpornosti.
Spectinomycin is active against avian E. coli, with observed rates of in vitro resistance of less than 20%.
Spektinomicin deluje proti ptičji E. coli, pri čemer opažene stopnje odpornosti in vitro znašajo manj kot 20 %.
Some sparse literature data relating to in-feed administration of lincomycin alone, show a majority of treatment failures or relapses.
Nekateri redki podatki iz literature, ki se nanašajo na samostojno dajanje linkomicina v krmo, kažejo večino neuspešnih zdravljenj ali relapsov.
There is only weak evidence that the effect on L. intracellularis infection would be superior to the single substances, and the respective roles of lincomycin and spectinomycin in the context of pig ileitis have not been well established.
Obstajajo le šibki dokazi, da bi bil učinek kombinacije na okužbo z L. intracellularis boljši od učinka posameznih snovi, ustrezni vlogi linkomicina in spektinomicina v okviru prašičjega ileitisa pa nista dobro raziskani.
Such use has not been associated with substantial evidence of efficacy of treatment or associated metaphylaxis; therefore, this also entails a high risk of resistance selection and treatment failure.
Taka uporaba ni povezana s trdnimi dokazi o učinkovitosti zdravljenja ali povezano metafilakso, zato sta njeni posledici visoko tveganje za selekcijo odpornosti in visoko tveganje za neuspešno zdravljenje.
In those studies the superiority of the combination over spectinomycin alone is not clearly established.
V teh študijah ni jasno dokazano, da je uporaba kombinacije boljša od uporabe spektinomicina samega.
Therefore, the Committee considers that there is no need to amend the currently approved withdrawal periods for pigs meat and offal for the products concerned by the procedure.
Zato odbor meni, da za zdravila, ki jih postopek zadeva, ni potrebe po spreminjanju trenutno odobrenih karenc za prašičje meso in organe.
A series of old studies using challenge models show efficacy of the combination, administered in the drinking water, in chickens infected by M. gallisepticum and/or E. coli, or by M. synoviae.
Niz starejših študij, ki uporabljajo provokacijske modele, kaže učinkovitost kombinacije, dane v vodo za pitje, pri piščancih, okuženih z M. gallisepticum in/ali E. coli ali M. synoviae.
In vitro studies as well as clinical efficacy data show that the lincomycin-spectinomycin combination is active against Lawsonia intracellularis.
In vitro študije in klinični podatki o učinkovitosti kažejo, da kombinacija linkomicina in spektinomicina deluje proti Lawsonia intracellularis.
Nonetheless, there are indications (from laboratory clinical studies) of clinical efficacy against E. coli located in and acquired via the respiratory tract, and against mycoplasmas, which are intracellular infections.
Kljub temu (na podlagi laboratorijskih kliničnih študij) obstajajo znaki klinične učinkovitosti proti E. coli, ki je v respiratornem traktu in je prek njega tudi pridobljena, ter proti mikoplazmam, pri katerih gre za okužbe znotraj celice.
1 under Article 34 of Directive 2001/82/EC, the product information was harmonised for Linco-Spectin 100, powder for use in drinking water for pigs and chickens, containing 222 mg lincomycin/g and 444.7 mg spectinomycin/g.
1 v skladu s členom 34 Direktive 2001/82/ES so bile informacije o zdravilu usklajene za zdravilo Linco-Spectin 100, prašek za uporabo v vodi za pitje za prašiče in piščance, ki vsebuje 222 mg linkomicina/g in 444,7 mg spektinomicina/g.
Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro, and data about the resistance status in that species are lacking.
Zaradi tehničnih omejitev je občutljivost Lawsonia intracellularis težko preskusiti in vitro, podatkov o stanju odpornosti pri tej vrsti pa ni dovolj.
Chickens: To be completed nationally.
Piščanci: Podatke je treba dopolniti v posameznih državah.
It follows that, while concerns could be expressed if pleuromutilins would remain the sole antimicrobial class indicated in swine dysentery, on the other hand the use of lincomycin against strains of intermediate susceptibility, might possibly contribute to pleuromutilin resistance development through co-selection.
Čeprav bi bilo mogoče izraziti pomisleke, če bi plevromutilini ostali edini razred protimikrobnih učinkovin, indiciran pri prašičji dizenteriji, iz tega sledi, da lahko po drugi strani uporaba linkomicina proti sevom z vmesno občutljivostjo prek koselekcije prispeva k razvoju odpornosti proti plevromutilinu.
Several pig enteric pathogens can be associated with B. hyodysenteriae infections and constitute possible targets for spectinomycin.
Z okužbami z B. hyodysenteriae je mogoče povezati več prašičjih enteričnih patogenov in ti patogeni predstavljajo možne tarče za spektinomicin.
Therefore, although overall the combination of lincomycin and spectinomycin showed to be clinically effective against E. coli in chickens, appropriate sentence should be included in SPC section 5.1 Pharmacodynamic properties to reflect the lack of absorption of spectinomycin in the gut.
Čeprav je v splošnem dokazano, da je kombinacija linkomicina in spektinomicina pri piščancih klinično učinkovita proti E. coli, je zato v poglavje 5.1 povzetka glavnih značilnosti zdravila Farmakodinamične lastnosti treba vključiti primeren stavek o odsotnosti absorpcije spektinomicina v črevesu.
During the Article 34 referral procedure (EMA/V/A/088) for Linco-Spectin 100, the limited efficacy data that were provided and the lack of residue data did not lead to the approval of any harmonised indications in poultry species other than chickens.
Na podlagi omejenih podatkov o učinkovitosti, predloženih med napotitvenim postopkom v skladu s členom 34 (EMA/V/A/088) za zdravilo Linco-Spectin 100, in pomanjkanja podatkov o ostankih niso bile odobrene nobene usklajene indikacije pri vrstah perutnine, ki niso piščanci.
The available in vitro susceptibility data indicate that spectinomycin and lincomycin can act synergistically in avian mycoplasmas such as M. gallisepticum.
Razpoložljivi podatki o občutljivosti in vitro kažejo, da spektinomicin in linkomicin lahko pri ptičjih mikoplazmah, kot je M. gallisepticum, delujeta sinergijsko.
Considering that formulations for administration in the drinking water are available, which are recommended for shorter treatment courses based on sufficient efficacy data, it is considered that the overall benefit-risk balance for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin is negative and consequently the marketing authorisations for these products should be withdrawn.
Ker so na voljo formulacije za dajanje v vodo za pitje, ki so na podlagi zadostnih podatkov o učinkovitosti priporočene za krajša zdravljenja, velja, da je splošno razmerje med tveganji in koristmi za predmešanice za zdravilno krmno mešanico in praške za dajanje v krmo, ki vsebujejo kombinacijo linkomicina in spektinomicina, negativno in da je treba zato umakniti dovoljenja za promet s temi zdravili.
In E. coli, a significant part of the strains show high MIC values (minimum inhibitory concentrations) against the lincomycin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined.
Pri E. coli znaten del sevov kaže visoke vrednosti MIK (minimalne inhibicijske koncentracije) pri kombinaciji linkomicina in spektinomicina ter je lahko klinično odporen, čeprav mejna vrednost ni določena.
The administration of the lincomycin and spectinomycin combination with the animal feed is currently recommended at relatively low doses and for prolonged periods (approximately 1 to 2.5 mg combined actives per kg bw (which is between 10% and 25% of the daily dose for powders for use in drinking water) for a relatively long period of 21 days).
Dajanje linkomicina in spektinomicina v kombinaciji z živalsko krmo je trenutno priporočena v sorazmerno nizkih odmerkih in v podaljšanih časovnih obdobjih (približno od 1 mg do 2,5 mg kombiniranih zdravilnih učinkovin na kilogram telesne mase (kar predstavlja od 10 % do 25 % dnevnega odmerka praškov za dajanje v vodo za pitje) v sorazmerno dolgem časovnem obdobju 21 dni).
This low dose for a long period entails a high risk of antimicrobial resistance selection in pathogenic and commensal bacteria and treatment failure.
Posledica tega nizkega odmerka v dolgem časovnem obdobju sta visoko tveganje za selekcijo odpornosti patogenih in komenzalnih bakterij proti protimikrobnim zdravilom ter visoko tveganje za neuspešno zdravljenje.
Therefore, the benefit-risk balance in relation to the use of the concerned class of products against swine dysentery caused by B. hyodysenteriae, is considered to be negative due to development of acquired resistance and high uncertainty about its impact in terms of in vivo efficacy.
Razmerje med tveganji in koristmi v zvezi z uporabo zadevnega razreda zdravil proti prašičji dizenteriji, ki jo povzroča B. hyodysenteriae, zaradi razvoja pridobljene odpornosti in visoke negotovosti glede njenega vpliva v smislu učinkovitosti in vivo zato velja za negativno.
No data were provided to support the use of a premix for medicated feeding stuff in chickens.
V podporo uporabi predmešanice za zdravilno krmno mešanico pri piščancih niso bili predloženi podatki.
Indications, dosages and residue data in pigs
Indikacije, odmerki in podatki o ostankih pri prašičih
25/28 North Wall Quay
Zoetis Ireland Limited 25/28 North Wall Quay
Delete, where applicable, any references to any poultry species other than chickens.
Kadar je ustrezno, izbrišite vse sklice na vse vrste perutnine, ki niso piščanci.
For the treatment and metaphylaxis of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli susceptible to lincomycin and spectinomycin, and associated with a low mortality rate.
Za zdravljenje in metafilakso kronične respiratorne bolezni (KRB), ki jo povzročata Mycoplasma gallisepticum in Escherichia coli, občutljivi na linkomicin in spektinomicin, ter je povezana z nizko stopnjo umrljivosti.
• the CVMP considered that on the basis of the available data for powders for use in drinking water containing a combination of lincomycin and spectinomycin, the overall benefit-risk balance is positive and the product information should be amended as provided in Annex III.
• odbor CVMP je menil, da je na podlagi razpoložljivih podatkov za praške za dajanje v vodo za pitje, ki vsebujejo kombinacijo linkomicina in spektinomicina, splošno razmerje med tveganji in koristmi pozitivno in da je treba informacije o zdravilih spremeniti, kot je določeno v Prilogi III.
Overall there is no significant evidence of a synergistic interaction in vitro between lincomycin and spectinomycin in B. hyodysenteriae, and most authors consider that the benefit of the combination with spectinomycin in the treatment of swine dysentery lies rather in the extension of the spectrum to a broader range of organisms, i.e. spectinomycin would act against concurrent pathogens or on enteric bacteria establishing conditions in the gut favourable to the development of swine dysentery.
V splošnem ni pomembnih dokazov medsebojnega sinergijskega delovanja linkomicina in spektinomicina in vitro pri B. hyodysenteriae, pri čemer večina avtorjev meni, da kombinacija s spektinomicinom pri zdravljenju prašičje dizenterije koristi predvsem zato, ker razširja spekter na večji nabor organizmov, tj. spektinomicin deluje proti sočasnim patogenom ali na enterične bakterije, ki v črevesu vzpostavljajo ugodne pogoje za razvoj prašičje dizenterije.
When considering lincomycin in vitro susceptibility data against B. hyodysenteriae, even if differences occur between geographical areas, and variability arises from the absence of standardised testing methodology, it appears clearly that the minimum inhibitory concentration (MIC) range is broad and http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/LincoSpectin_100_and_associated_names/vet_referral_000097.jsp&mid=WC0b01ac05805c5170
Tudi če pri preučevanju podatkov o občutljivosti linkomicina in vitro za B. hyodysenteriae med geografskimi območji prihaja do razlik in se zaradi odsotnosti standardizirane metodologije testiranja http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/LincoSpectin_100_and_associated_names/vet_referral_000097.jsp&mid=WC0b01ac05805c5170