FrancophonIA/ELRC3.0 huggingface dataset:
English: Parque Empresarial La Moraleja Alcobendas 28108 Spain
Slovenian: de Europa, 20B Parque Empresarial La Moraleja Alcobendas 28108 Spain
English: Add, to all products: 4.4 Special warnings for each target species
Slovenian: Vsem zdravilom dodajte: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto
English: Messogeion Ave 15451 Neo Psychiko Athens
Slovenian: 15451 Neo Psychiko Athens
English: 49377 Vechta
Slovenian: 49377 Vechta Germany
English: In those bacterial species there is no evidence of an important resistant population or of an evolving resistance status.
Slovenian: Pri teh vrstah bakterij ni dokazov o pomembni odporni populaciji ali o stanju razvijajoče se odpornosti.
English: Moreover, product use in such conditions is associated with a risk of further resistance selection or co-selection.
Slovenian: Poleg tega je uporaba zdravila v takih pogojih povezana s tveganjem za dodatno selekcijo ali koselekcijo odpornosti.
English: 3, although the two situations are not directly comparable since the MIC values for tylosin are, overall, higher, and the doses used and pharmacokinetics may also differ.
Slovenian: 3, čeprav položaja nista neposredno primerljiva, saj so vrednosti MIK za tilozin v splošnem višje, zato se lahko razlikujejo tudi uporabljeni odmerki in farmakokinetika.
English: In E. coli and Salmonella, based on in vitro data, spectinomycin resistance rates of about 30-50% can be expected.
Slovenian: Pri E. coli in Salmonella je glede na podatke in vitro mogoče pričakovati stopnje odpornosti spektinomicina, ki znašajo od 30 do 50 %.
English: Thus the overall benefit-risk balance for such product formulations is considered negative.
Slovenian: Zato splošno razmerje med tveganji in koristmi za take formulacije zdravil velja za negativno;
English: No firm clinical breakpoint could be proposed which would allow the prediction of clinical efficacy in the presence of poorly susceptible isolates, which currently represent the majority of isolates.
Slovenian: Ni bilo mogoče predlagati trdnih kliničnih mejnih vrednosti, ki bi omogočale napovedovanje klinične učinkovitosti v prisotnosti slabo občutljivih izolatov, ki trenutno predstavljajo večino izolatov.
English: Those data indicate that strains with some level of MIC increase might nevertheless be effectively treated, leading to a favourable clinical outcome.
Slovenian: Ti podatki kažejo, da so sevi, pri katerih je MIK nekoliko povečana, vseeno lahko učinkovito zdravljeni, kar privede do ugodnega kliničnega izida.
English: In addition, in the study the induced clinical signs can only be considered only as moderate, since no mortality occurred and clinical scores were rather low.
Slovenian: Poleg tega je mogoče sprožene klinične znake v študiji šteti le za zmerne, saj ni prišlo do umrljivosti, klinični rezultati pa so bili precej nizki.
English: Deletion of target species chickens from the concerned products could increase the use of antimicrobial substances currently considered as even more critical in terms of the consequences of selection of resistance and relevance for public health, such as fluoroquinolones.
Slovenian: Izbris piščancev ciljnih vrst iz zadevnih zdravil lahko poveča uporabo protimikrobnih snovi, ki trenutno veljajo za še bolj kritične v smislu posledic selekcije odpornosti in pomena za javno zdravje, kot so fluorokinoloni.
English: In addition, some mutations in that area can confer increased MICs to both pleuromutilins and lincosamides.
Slovenian: Poleg tega lahko nekatere mutacije na tem področju povzročijo povečane MIK pri plevromutilinih in linkozamidih.
English: The associated aetiology of B. hyodysenteriae and its role in pathogenesis is however not fully clear and no bacteriological follow-up has been performed in those studies.
Slovenian: Vendar sorodna etiologija B. hyodysenteriae in njena vloga pri patogenezi ni popolnoma jasna, v teh študijah pa ni bila opravljena nobena bakteriološka kontrola.
English: From the available information it appears that the resistance rates in the target bacteria are relatively low, and there is no indication of an evolving status.
Slovenian: Iz informacij, ki so na voljo, se zdi, da so stopnje odpornosti pri ciljnih bakterijah sorazmerno nizke, in ni znakov razvijajočega se stanja.
English: Animals must not be slaughtered for human consumption during treatment.
Slovenian: Živali se med zdravljenjem ne smejo zaklati za prehrano ljudi.
English: This major uncertainty cannot be addressed until new clinical studies are conducted, under well controlled conditions including proper diagnoses and follow-up of the bacterial pathogens involved and determination of their in vitro susceptibility.
Slovenian: Te glavne negotovosti ni mogoče obravnavati, dokler se ne izvedejo nove klinične študije v dobro nadzorovanih pogojih, vključno s pravilnimi diagnozami, kontrolo vpletenih bakterijskih patogenov in določanjem njihove občutljivosti in vitro.
English: It is possible that the substances are synergistic, act at different locations (intra- and extracellularly), or act by influencing the concurrent gut flora conditions.
Slovenian: Možno je, da sta snovi sinergijski, da delujeta na različnih lokacijah (znotraj in zunaj celice) ali pa tako, da vplivata na sočasne pogoje v črevesni flori.
English: Therefore, most available clinical data do not take into account the current status of in vitro susceptibility/resistance of the concerned bacterial species.
Slovenian: Zato večina razpoložljivih kliničnih podatkov ne upošteva trenutnega stanja občutljivosti/odpornosti zadevnih bakterijskih vrst in vitro.
English: Its added value above the single substances in that context has been demonstrated in old clinical studies, although with limitations at the level of bacteriological inclusion criteria and bacteriological follow-up.
Slovenian: Njena dodana vrednost v primerjavi s posameznimi snovmi v tem okviru je dokazana v starejših kliničnih študijah, čeprav z omejitvami glede meril za stopnjo bakteriološke vključenosti in bakteriološke kontrole.
English: Podružnica Zagreb za promidžbu Petra Hektorovića 2 10000 Zagreb Croatia
Slovenian: Petra Hektorovića 2 10000 Zagreb Croatia
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, and marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in imetnikov dovoljenj za promet z zdravilom v državah članicah
English: A series of old field studies, which investigated the impact of a systematic treatment on the zootechnical performances of flocks in comparison to a positive control, are also presented.
Slovenian: Predstavljen je bil tudi niz starejših študij, v katerih so preučevali vpliv sistematskega zdravljenja na zootehnične rezultate jat v primerjavi s pozitivno kontrolno skupino.
English: The indication against swine dysentery caused by B. hyodysenteriae, can no longer be maintained and should be removed.
Slovenian: Indikacije pri prašičji dizenteriji, ki jo povzroča B. hyodysenteriae, ni več mogoče navajati in mora biti odstranjena.
English: In Campylobacter, variable but possibly high resistance rates were shown against lincomycin; however the situation could be more complex because those bacteria are also considered susceptible to spectinomycin, for which few data are available.
Slovenian: Pri Campylobacter so bile dokazane spremenljive, a potencialno visoke stopnje odpornosti proti linkomicinu; položaj pa je morda bolj zapleten, saj te bakterije veljajo tudi za občutljive na spektinomicin, za katerega obstaja malo podatkov.
English: For similar reasons, i.e. because of high in vitro resistance rates, in 2014, in the context of a referral procedure (EMEA/V/A/100)
Slovenian: Zaradi podobnih razlogov, tj. zaradi visokih stopenj odpornosti in vitro, je odbor CVMP leta 2014 v okviru napotitvenega postopka (EMEA/V/A/100)
English: Nevertheless, the available in vitro susceptibility data suggest that the expected benefit is now considerably reduced due to a rapid and widespread MIC increase in B. hyodysenteriae.
Slovenian: Kljub temu razpoložljivi podatki o občutljivosti in vitro kažejo, da je pričakovana korist zdaj zelo zmanjšana zaradi hitrega in zelo razširjenega povečanja MIK pri B. hyodysenteriae.
English: Although doses are only expressed as levels in water, it can be estimated that the optimal doses range from 75 to 300 mg combined actives/kg bw.
Slovenian: Čeprav so odmerki izraženi le kot vrednosti v vodi, je mogoče oceniti, da optimalni odmerki znašajo od 75 mg do 300 mg kombiniranih zdravilnih učinkovin na kilogram telesne mase.
English: 2 Km Paiania-Spata Av
Slovenian: AVICO AE 2 Km Paiania-Spata Av
English: Data from a pilot challenge study suggest efficacy in case of proliferative enteropathy associated with a colibacillosis outbreak, although the study was not formally designed to investigate efficacy against E. coli.
Slovenian: Podatki iz pilotne provokacijske študije kažejo učinkovitost v primeru proliferativne enteropatije, povezane z izbruhom kolibaciloze, čeprav študija uradno ni bila zasnovana za preučevanje učinkovitosti proti E. coli.
English: SUPER´S DIANA, S.L
Slovenian: SUPER´S DIANA, S.L Ctra.
English: All indications and dosing instructions corresponding to systematic prevention in healthy animals or to fixed antimicrobial levels in the drinking water relate to variable and uncontrolled antimicrobial exposures, should be deleted from the product literature.
Slovenian: Vse indikacije in navodila za odmerjanje, ki ustrezajo sistematičnemu preprečevanju pri zdravih živalih ali nespremenljivim vrednostim protimikrobnih učinkovin v vodi za pitje, povezanimi z spremenljivimi in nenadzorovanimi izpostavljenostmi protimikrobnim učinkovinam, morajo biti izbrisani iz literature o zdravilu.
English: Delete, where applicable, any references to swine dysentery caused by Brachyspira hyodysenteriae, or to other bacterial species than those specified in the indications.
Slovenian: Kadar je ustrezno, izbrišite vse sklice na prašičjo dizenterijo, ki jo povzroča Brachyspira hyodysenteriae, ali na druge bakterijske vrste, ki niso navedene v indikacijah.
English: However this has not been validated and it has not been shown that spectinomycin undergoes any metabolism in any species and it appears from PK data that most of the therapeutic dose can be recovered from faeces and urine.
Slovenian: Vendar to ni bilo potrjeno in ni bilo dokazano, da je spektinomicin pri kateri koli vrsti na kakršen koli način presnovljen, iz farmakokinetičnih podatkov pa se zdi, da je mogoče večino terapevtskega odmerka najti v iztrebkih in urinu.
English: and against some gram-negative bacteria such as E. coli.
Slovenian: in po gramu negativnim bakterijam, kot je E. coli.
English: 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.
Slovenian: Verjetnejša razlaga mehanizma delovanja spektinomicina proti respiratorni E. coli je posredni učinek na črevesno floro, zaradi česar se zmanjša izločanje v okolje.
English: The risk for possible in vitro resistant strains should be included in the product information.
Slovenian: Tveganje za potencialne seve, odporne in vitro, mora biti vključeno v informacije o zdravilu.
English: 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.
Slovenian: 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.
English: Denmark Pfizer Oy Animal Health
Slovenian: Pfizer Oy Animal Health
English: Where the following target species have already been approved, the wording below relating to the relevant species should be used:
Slovenian: Kadar je bila uporaba pri naslednjih ciljnih živalskih vrstah že odobrena, je treba v zvezi z zadevnimi živalskimi vrstami uporabiti spodnje besedilo:
English: These include notably, Escherichia coli, Salmonella spp., and Campylobacter spp.
Slovenian: Med njimi so predvsem Escherichia coli, Salmonella spp.
English: Lincomycin-Spectinomycin 1,1% "Animed Service"Pulver zum Eingeben für Schweine
Slovenian: Lincomycin-Spectinomycin 1,1% "Animed Service"Pulver zum Eingeben für Schweine prašek za dajanje v krmo
English: 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.
Slovenian: Zaključeno je bilo, da večina izolatov Brachyspira kaže odpornost in vitro in da ni pričakovati zadostne učinkovitosti peroralnega tilozina pri zdravljenju prašičje dizenterije.
English: 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))
Slovenian: 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))
English: 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.
Slovenian: 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.
English: The macrolide tylosin is closely related to lincosamides and binds to an overlapping ribosomal site.
Slovenian: Makrolid tilozin je tesno povezan z linkozamidi in se veže na prekrivajoče se mesto ribosoma.
English: No further data have been presented in the framework of this referral to support any indications in poultry species other than chickens.
Slovenian: V okviru te napotitve niso bili predstavljeni dodatni podatki v podporo kakršnim koli indikacijam pri vrstah perutnine, ki niso piščanci.
English: 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))
Slovenian: 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))
English: Pigs: To be completed nationally.
Slovenian: Prašiči: Podatke je treba dopolniti v posameznih državah.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Germany Kon-Pharma GmbH Senator-Bauer-Str.
Slovenian: Kon-Pharma GmbH Senator-Bauer-Str.
English: In addition, spectinomycin is polar and does not readily cross membranes to distribute into the intracellular compartment.
Slovenian: Poleg tega je spektinomicin polaren in ne prehaja zlahka skozi membrane ter se ne porazdeli zlahka v notranjost celic.
English: The data available do not allow the establishment of a clear time pattern for the evolution of MICs.
Slovenian: Podatki, ki so na voljo, ne omogočajo določitve jasnega časovnega vzorca za razvoj minimalnih inhibicijskih koncentracij.
English: Spectinomycin is also active against Salmonella spp., and both compounds are active against Campylobacter spp.
Slovenian: Spektinomicin deluje tudi proti Salmonella spp., obe učinkovini pa delujeta proti Campylobacter spp.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The presence of the disease in the group must be established before the product is used.
Slovenian: Pred uporabo zdravila je treba ugotoviti prisotnost bolezni v skupini.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Spectinomycin is active against avian E. coli, with observed rates of in vitro resistance of less than 20%.
Slovenian: Spektinomicin deluje proti ptičji E. coli, pri čemer opažene stopnje odpornosti in vitro znašajo manj kot 20 %.
English: Some sparse literature data relating to in-feed administration of lincomycin alone, show a majority of treatment failures or relapses.
Slovenian: Nekateri redki podatki iz literature, ki se nanašajo na samostojno dajanje linkomicina v krmo, kažejo večino neuspešnih zdravljenj ali relapsov.