FrancophonIA/ELRC3.0 huggingface dataset:
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Slovenian: Če to ni mogoče, naj zdravljenje temelji na lokalni (regionalni, nivoju kmetije) epidemiološki informaciji glede občutljivosti ciljnih bakterij.
English: Do not use in laying hens.
Slovenian: Ne uporabite pri kokoših nesnicah.
English: Possible resistance generated by lincomycin use in animals may impact animal health, including through cross-resistance with macrolides.
Slovenian: Morebitna odpornost, ki jo lahko povzroči uporaba linkomicina pri živalih, lahko vpliva na zdravje živali, vključno prek navzkrižne odpornosti z makrolidi.
English: Several old challenge laboratory studies showed efficacy of the combination against experimental inoculations with Mycoplasma spp.
Slovenian: Več starih provokacijskih laboratorijskih študij je pokazalo učinkovitost kombinacije proti eksperimentalnim inokulacijam z Mycoplasma spp.
English: The potential risk of resistance development which might impact product efficacy, and overall animal and human health, is limited through:
Slovenian: Morebitno tveganje razvoja odpornosti, ki lahko vpliva na učinkovitost zdravila, in morebitno tveganje za splošno zdravje živali ter ljudi sta omejena z:
English: The combination showed beneficial effects as regards lesion reduction and zootechnical endpoints, and bacterial shedding was completely stopped.
Slovenian: Kombinacija je pokazala koristne učinke glede zmanjšanja lezij in zootehničnih opazovanih dogodkov, bakterijsko razsejanje pa je bilo popolnoma ustavljeno.
English: Although in those studies doses were expressed as concentrations in drinking water so that actual doses in terms of mg/kg bw could only be estimated, the estimations were deemed sufficiently close to the recommended regimen.
Slovenian: Čeprav so bili v teh študijah odmerki izraženi kot koncentracije v pitni vodi, tako da je bilo dejanske odmerke v mg/kg telesne mase mogoče samo oceniti, so bile ocene zadostni približki priporočenemu režimu.
English: and against some gram-negative bacteria such as E. coli.
Slovenian: in proti nekaterim gramnegativnim bakterijam kot je E. Coli.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe, imetnikov dovoljenja za promet v državah članicah
English: Resistance can be a direct concern when affecting zoonotic pathogens such as Campylobacter and Enterococcus, or can be transferred horizontally to human pathogens via mobile genetic elements.
Slovenian: Odpornost bi bila lahko neposredna težava, kadar prizadene zoonotske patogene, kot sta Campylobacter in Enterococcus, in bi se lahko na človeške patogene prenašala horizontalno prek prenosnih genskih elementov.
English: The overall benefit-risk balance of the product for use in pigs and chickens was deemed positive subject to the recommended changes in the product information (see Annex III).
Slovenian: Celotno razmerje med tveganji in koristmi za zdravilo za uporabo pri prašičih in piščancih je bilo ocenjeno kot ugodno pod pogojem, da se upoštevajo priporočene spremembe v informacijah o zdravilu (glejte Prilogo III).
English: Indirect benefits
Slovenian: Posredne koristi
English: Belgium referred the issue due to divergent national decisions having been taken by the EU Member States resulting in discrepancies in the product information for Linco-Spectin 100 and its associated names.
Slovenian: Belgija je sprožila napotitev zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice EU, kar je povzročilo odstopanja v informacijah o zdravilu za zdravilo Linco-Spectin 100 in z njim povezana imena.
English: Rare cases of irritability/excitation, skin rash/pruritus were also observed.
Slovenian: V redkih primerih so opazili tudi razdražljivost/vznemirjenost, kožni izpuščaj/pruritus.
English: Not authorised for use in birds producing or intended to produce eggs for human consumption.
Slovenian: Ni dovoljena uporaba pri pticah, ki proizvajajo ali bodo proizvajala jajca so namenjena prehrani ljudi.
English: The oral use of preparations containing lincomycin is only indicated in swine and chickens.
Slovenian: Oralna uporaba pripravkov, ki vsebujejo linkomicin je indicirana samo pri prašičih in piščancih.
English: * There are no new clinical trials, field trials or publications demonstrating the effectiveness of the lincomycin-spectinomycin combination against modern outbreaks of swine dysentery, and based on current approved dosing regimens.
Slovenian: • ni novih kliničnih preskušanj, preskušanj na terenu ali publikacij, ki bi dokazovali učinkovitost kombinacije linkomicina in spektinomicina proti sodobnim izbruhom prašičje dizenterije na podlagi trenutno odobrenih režimov odmerjanja.
English: In chicken the product is already indicated in many EU Member States for the treatment of CRD, associated to Mycoplasma and/or E. coli.
Slovenian: Pri piščancih je zdravilo v mnogih državah članicah EU že indicirano za zdravljenje KRB, povezane z Mycoplasma in/ali E. coli.
English: Diagnosis should be reconsidered if improvement is not seen after 5 days.
Slovenian: Če po 5 dneh ne pride do izboljšanja, je treba ponovno razmisliti o pravilnosti diagnoze.
English: * The inclusion of information about resistance status and warnings about prudent use as regards resistance, in SPC sections 4.4 Special warnings for each target species, 4.5 (i) Special precautions for use in animals and 5.1 Pharmacodynamic properties.
Slovenian: • vključitvijo informacij o stanju odpornosti in opozoril o preudarni uporabi zaradi odpornosti v povzetek glavnih značilnosti zdravila, poglavja 4.4 Posebna opozorila za vsako ciljno živalsko vrsto, 4.5 (i) Posebni previdnostni ukrepi za uporabo pri živalih in 5.1 Farmakodinamične lastnosti.
English: Similar results were observed following single oral doses of 4.4 and 11.0 mg/kg body weight in pigs.
Slovenian: Podobne rezultate so opazili po dajanju enkratnih odmerkov 4,4 in 11,0 mg/kg/telesne teže prašičem.
English: Lincomycin may be either bactericidal or bacteriostatic.
Slovenian: Linkomicin lahko deluje baktericidno ali bakteriostatično.
English: the CVMP has recommended the amendment of the marketing authorisations for Linco-Spectin 100 and its associated names as referred in Annex I for which the summary of product characteristics, labelling and package leaflet are set out in Annex III.
Slovenian: je odbor CHMP priporočil spremembo dovoljenj za promet z zdravilom Linco-Spectin 100 in z njim povezanimi imeni, kot je navedeno v Prilogi I in za katera so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo opredeljeni v Prilogi III.
English: the MIC distribution appears to be bimodal, with a significant number of strains showing high values; this could partly correspond to natural (intrinsic) resistance.
Slovenian: bimodalna, s precejšnjim številom sevov, ki kažejo visoke vrednosti; to bi lahko deloma ustrezalo naravni (intrinzični) odpornosti.
English: Animals must not be slaughtered for human consumption during treatment.
Slovenian: Živali se med zdravljenjem ne sme zaklati za prehrano ljudi.
English: There is often complete cross-resistance between lincomycin and clindamycin.
Slovenian: Pogosto pride do popolne navzkrižne odpornosti med linkomicinom in klindamicinom.
English: Use the following indications as a basis for the precise calculation of incorporation rate of the veterinary medicinal product in drinking water.
Slovenian: Naslednje indikacije uporabite kot osnovo za natančen izračun količine zdravila za uporabo v veterinarski medicini, ki ga je treba dodati v vodo za pitje.
English: Poultry: for administration as the sole daily source of drinking water until consumed, followed by non-medicated water for the rest of the day, if necessary
Slovenian: Perutnina: za dajanje v vodo za pitje kot edini dnevni vir vode za pitje dokler se je ne konzumira, nato pa se v preostanku dneva, če je treba, živalim doda še vodo brez zdravila.
English: Rivium Westlaan 74, 2909 LD Capelle a/d Ijssel The Netherlands
Slovenian: Nizozemska Zoetis BV Rivium Westlaan 74, 2909 LD Capelle a/d Ijssel Nizozemska
English: * In the newly provided clinical efficacy study the product clearly induced improvement of clinical signs of CRD and reduced the extent of bacterial invasion.
Slovenian: • v novo predloženi klinični študiji učinkovitosti je zdravilo jasno izboljšalo klinične znake KRB in zmanjšalo obseg vdora bakterij.
English: Not authorised for use in birds producing eggs for human consumption, including replacement chicks which are intended to produce eggs for human consumption.
Slovenian: Ni dovoljena uporaba pri pticah, katerih jajca so namenjena prehrani ljudi, vključno z nadomestnimi kokošmi nesnicami, katerih jajca so namenjena prehrani ljudi.
English: MLS antimicrobials are listed by WHO (AGISAR, 2009)3 as critically important for the treatment of certain zoonotic infections in humans (such as Campylobacter infections).
Slovenian: Svetovna zdravstvena organizacija (AGISAR, 2009)3 antibiotike MLS razvršča kot kritično pomembne za zdravljenje določenih zoonoz pri ljudeh (kot so okužbe s Campylobacter).
English: Studies performed in various animal species have demonstrated that spectinomycin undergoes limited absorption from the intestine (less than 4-7%) after oral administration.
Slovenian: Študije pri različnih živalskih vrstah so pokazale, da se spektinomicin po peroralnem dajanju le delno absorbira v črevesju (manj kot 4-7 %).
English: The possible impact on clinical efficacy of the high in vitro resistance rate evidenced in B. hyodysenteriae was not assessed in recent clinical studies; however, in the context of this Article 34 referral procedure, aiming at harmonising the conditions of authorisation of an already approved product, it was considered that the indication should not be removed on that basis.
Slovenian: Morebitnega vpliva visoke stopnje odpornosti, dokazane in vitro pri B. hyodysenteriae, na klinično učinkovitost niso ocenili v nedavnih kliničnih študijah, vendar so v sklopu tega napotitvenega postopka v skladu s členom 34, katerega cilj je bil uskladitev pogojev dovoljenja za promet z že odobrenim zdravilom, menili, da te indikacije na podlagi tega ni treba ukiniti.
English: * Resistance to the concerned compounds in the target bacteria shows no unfavourable evolution over time and no greater concern than for other compounds used similarly;
Slovenian: • Odpornost ciljnih bakterij na zadevni učinkovini ne kaže neželenega razvoja v času in prisotni zadržki niso nič večji kot pri drugih učinkovinah, ki se uporabljajo na podoben način.
English: These were not GLP or good clinical practice (GCP)-compliant and the target clinical and bacteriological condition was not well defined in the study reports.
Slovenian: Te študije niso bile skladne z DLP ali dobro klinično prakso (DKP) in ciljni klinični ter bakteriološki pogoji niso bili dobro opredeljeni v poročilih iz študij.
English: Therefore it was considered by the CVMP that the indication in chickens should be maintained, however it should be adapted as follows: “For the treatment and prevention of CRD caused by Mycoplasma gallisepticum and E. coli, associated with a low mortality rate.
Slovenian: Odbor CVMP je zato menil, da je treba indikacijo pri piščancih ohraniti, vendar jo je treba prilagoditi na naslednji način: »Za zdravljenje in preprečevanje KRB, ki jo povzročata Mycoplasma gallisepticum in E. coli, povezana z nizko stopnjo umrljivosti.
English: Overall, considering also older literature data, the relatively narrow MIC ranges and low MIC50 and MIC90 values, together with a monomodal distribution are indicative of a low resistance level which seems not to be evolving.
Slovenian: Upoštevajoč tudi starejše podatke iz literature relativno ozki razponi MIK in majhne vrednosti MIK50 ter MIK90 skupaj z monomodalno porazdelitvijo na splošno kažejo na majhno stopnjo odpornosti, za katero je videti, da se ne razvija naprej.
English: Spectinomycin has no significant clinical effect on B. hyodysenteriae.
Slovenian: Spektinomicin nima nobenega pomembnega kliničnega učinka na B. hyodysenteriae.
English: Do not use in case of hypersensitivity to the active substances or any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti na zdravilni učinkovini, ali na katero koli pomožno snov.
English: In vitro studies as well as clinical efficacy data show that the lincomycin-spectinomycin combination is active against Lawsonia intracellularis.
Slovenian: In vitro študije kot tudi klinični podatki o učinkovitosti kažejo, da kombinacija linkomicin spektinomicin deluje proti Lawsonia intracellularis.
English: Do not administer with kaolin or pectine as they impair lincomycin absorption.
Slovenian: Ne dajajte skupaj s kaolinom ali pektinom, ker lahko vplivata na absorpcijo linkomicina.
English: For the preparation of drinking water, the incorporation rate of the veterinary medicinal product in water will depend on the body weight of the animals and their actual daily intake of water.
Slovenian: Pri pripravi pitne vode je delež dodanega zdravila za uporabo v veterinarski medicini odvisen od telesne teže živali in dejanske količine popite vode na dan.
English: The harmonised dose of 50 mg/kg bw is overall the lowest approved one among the national authorisations and the most frequent recommendation for treatment only.
Slovenian: Usklajeni odmerek 50 mg/kg telesne mase je na splošno najmanjši nacionalno odobreni odmerek in najpogostejše priporočeni odmerek samo za zdravljenje.
English: * All modern authors appear to agree that there is widespread resistance of B. hyodysenteriae to lincomycin, although there is no clinical breakpoint available and it is not known to which extent strains with increased MICs are clinically resistant;
Slovenian: • videti je, da se vsi sodobni avtorji strinjajo, da je odpornost B. hyodysenteriae na linkomicin zelo razširjena, čeprav klinične mejne vrednosti niso na voljo in ni znano, v kolikšni meri so sevi s povečanimi MIK klinično odporni;
English: and other atypical gut organisms, is probably dependent on conditions established in the gut by other bacteria.
Slovenian: in drugi atipični črevesni organizmi verjetno odvisna od pogojev, ki jih v črevesu ustvarijo druge bakterije.
English: 1 Pringle, M. et al - Antimicrobial susceptibility of porcine Brachyspira hyodysenteriae and Brachyspira pilosicoli isolated in Sweden between 1990 and 2010.
Slovenian: Antimicrobial susceptibility of porcine Brachyspira hyodysenteriae and Brachyspira pilosicoli isolated in Sweden between 1990 and 2010.
English: Do not allow rabbits, rodents (e.g. chinchillas, hamsters, guinea pigs), horses or ruminants access to water or feeds containing lincomycin.
Slovenian: Ne dovolite, da imajo kunci, glodalci (npr. činčile, hrčki, morski prašički), konji ali prežvekovalci dostop do vode ali krme, ki vsebuje linkomicin.
English: Lincomycin resistance mediated by efflux pumps, or by inactivating enzymes, has also been described.
Slovenian: Prav tako je bila opisana tudi odpornost linkomicina, ki je posredovana z izlivnimi črpalkami ali z inaktiviranjem encimov.
English: Although this risk has not been unequivocally assessed, the possibility of impact on human health through cross-resistance to clindamycin and other substances of the macrolides, lincosamides and streptogramins (MLS) group is a reality.
Slovenian: Čeprav tveganja niso jasno ocenjena, je prisotna možnost vpliva na zdravje človeka zaradi navzkrižne odpornosti proti klindamicinu in drugim učinkovinam iz skupine makrolidov, linkozamidov ter streptograminom (MLS).
English: Taking into account all data, the CVMP considered that this indication can be maintained.
Slovenian: Upoštevajoč vse podatke je odbor CHMP menil, da se lahko ta indikacija ohrani.
English: Literature data indicate that decreased susceptibility in B. hyodysenteriae could be overcome to some extent by the high concentrations attained locally.
Slovenian: Podatki iz literature kažejo, da je mogoče zmanjšano občutljivost pri B. hyodysenteriae do neke mere premagati z velikimi lokalnimi koncentracijami.
English: While the lincosamides are generally considered to be bacteriostatic agents, the activity is depending on the sensitivity of the organism and concentration of the antibiotic.
Slovenian: Linkozamidi spadajo na splošno med bakteriostatike, njihovo delovanje je odvisno od občutljivosti organizma in koncentracije antibiotika.
English: Strains with chromosomal resistance do not show cross-resistance with aminoglycosides.
Slovenian: Sevi s kromosomsko odpornostjo ne kažejo navzkrižne odpornosti z aminoglikozidi.
English: The referral leads to full harmonisation of the product information.
Slovenian: S tem napotitvenim postopkom so se informacije o zdravilu popolnoma uskladile.
English: The efficacy appeared better than with lincomycin alone, and slightly better than with spectinomycin alone.
Slovenian: Učinkovitost je bila videti boljša kot pri samostojnem linkomicinu in nekoliko boljša kot pri samostojnem spektinomicinu.
English: In several other SPCs, the dose is expressed as a drinking water concentration which amounts to about 50 mg/kg bw in a significant part of the animals;
Slovenian: V več drugih povzetkih glavnih značilnosti zdravila je odmerek izražen kot koncentracija v pitni vodi, kar je enako približno 50 mg/kg telesne mase pri pomembnem deležu živali;
English: Any medicated water which is not consumed within 24 hours should be discarded.
Slovenian: Medicirano vodo, ki jo živali ne popijejo v 24 urah, je treba odstraniti.
English: Also in one of the field studies the target condition was a mixed enteric and respiratory infection involving Salmonella and Mycoplasma, which is only poorly relevant to the claimed indication.
Slovenian: Poleg tega je bil v eni od študij na terenu ciljni pogoj mešana enterična in respiratorna okužba z mikroorganizmoma Salmonella in Mycoplasma, kar je samo malo pomembno za navedeno indikacijo.
English: Literature and the proprietary old in vitro susceptibility data show that the overall lincomycin minimum inhibitory concentration (MIC) range for B. hyodysenteriae is very wide and the population MIC50 and MIC90 values are high.
Slovenian: Literatura in stari lastniški podatki o občutljivosti in vitro kažejo, da je splošni razpon minimalne inhibitorne koncentracije (MIK) linkomicina za B. hyodysenteriae zelo širok in da so vrednosti MIK50 ter MIK90 v populaciji velike.
English: Pharmacovigilance reports have not reported a lack of efficacy of Linco-Spectin 100 in the proposed harmonised indication in chicken.
Slovenian: Farmakovigilančna poročila niso poročala o pomanjkanju učinkovitosti zdravila Linco-Spectin 100 pri predlagani usklajeni indikaciji pri piščancih.
English: This powder is for use in drinking water only and should be dissolved before use.
Slovenian: Ta prašek je samo za uporabo v pitni vodi in ga je treba pred uporabo raztopiti.
English: clinical data were provided to substantiate this claim.
Slovenian: Za utemeljitev te trditve niso bili predloženi nobeni sodobni klinični podatki.
English: Levels were detectable for 12 to 16 hours, with peak concentrations occurring at 4 hours.
Slovenian: Vrednosti koncentracij v serumu se je dalo izmeriti 12 do 16 ur, vrh koncentracij pa je bil dosežen po 4 urah.
English: Resistance to lincomycin is frequently conferred by plasmid-borne factors (erm genes) coding for methylases modifying the ribosomal binding site and frequently leading to cross-resistance to other antimicrobials of the MLSb group.
Slovenian: Odpornost na linkomicin je pogosto določena s faktorji prenosa preko plazmidov (erm geni), ki kodirajo metilazo in tako spremenijo mesto vezave na ribosomih in pogosto privedejo do navzkrižne odpornosti na druga protimikrobna zdravila iz MLSb skupine.
English: Particularly in chicken respiratory diseases, the availability of Linco-Spectin 100 could limit the use of other antimicrobials considered as more critical for animal and human health, e.g. fluoroquinolones.
Slovenian: Razpoložljivost zdravila Linco-Spectin 100 bi lahko predvsem pri respiratornih boleznih piščancev omejila uporabo drugih antibiotikov, ki so bolj kritični za zdravje živali in človeka, npr. fluorokinoloni.
English: The in vitro susceptibility data for Escherichia coli and Salmonella were not extensive but among them there were data from a newly conducted good laboratory practice (GLP)-compliant pan-European MIC survey involving 100 E. coli and 100 Salmonella isolates from clinical cases.
Slovenian: Podatki o občutljivosti in vitro za Escherichia coli in Salmonella niso bili obsežni, vendar so bili med njimi podatki iz nove panevropske raziskave MIK, izvedene skladno z dobro laboratorijsko prakso (DLP), ki je vključila 100 izolatov E. coli in 100 izolatov Salmonella iz kliničnih primerov.
English: The table below shows the volume of water to be used for dilution of 150 g of the veterinary medicinal product.
Slovenian: Spodnja tabela prikazuje volumen vode, ki se uporabi, da se raztopi 150 g zdravila za uporabo v veterinarski medicini.
English: The product is used in the proposed indications (swine dysentery and proliferative enteropathy) for several decades in many EU Member States, on the basis of the complementary activity spectra of lincomycin and spectinomycin on the primary pathogens B. hyodysenteriae and L. intracellularis and the potentially associated enteric pathogens such as E. coli.
Slovenian: Zdravilo se za predlagani indikaciji (prašičja dizenterija in proliferativna enteropatija) v mnogih državah članicah EU uporablja že več desetletij, kar temelji na dopolnjujočih se spektrih delovanja linkomicina in spektinomicina na primarna patogena B. hyodysenteriae ter L. intracellularis in na morda sorodne enterične patogene, kot je E. coli.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substances:
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN Zdravilne učinkovine:
English: Chromosomal one-step mutation to high-level spectinomycin resistance develops in many enteric bacteria (such as E. coli).
Slovenian: Mutacija kromosoma v enem koraku, ki povzroči visoko stopnjo odpornosti na spektinomicin se razvije pri mnogih črevesnih bakterijah (kot je E. coli).
English: Pharmacovigilance reports have not reported a lack of efficacy of Linco-Spectin 100 in the recommended harmonised indications in pigs.
Slovenian: Farmakovigilančna poročila niso poročala o pomanjkanju učinkovitosti zdravila Linco-Spectin 100 pri priporočenih usklajenih indikacijah pri prašičih.
English: This reflects the ready acquisition of resistance determinants by the bacterium.
Slovenian: To kaže na pripravljenost bakterije za pridobitev determinant odpornosti.
English: The older field studies were conducted in a context of systematic prophylaxis and used two-phase dosing regimens; the conditions of those studies do not provide support for the proposed 50 mg/kg bw dose.
Slovenian: Starejše terenske študije so izvedli v sklopu sistematične profilakse, pri čemer so uporabili dvofazne režime odmerjanja; pogoji teh študij ne podpirajo predlaganega odmerka 50 mg/kg telesne mase.
English: Plasmid-mediated resistance is less common.
Slovenian: Odpornost, ki se prenese preko plazmidov je manj pogosta.
English: This is indicative of a significant rate of high-level resistance although no firm clinical breakpoint has been set.
Slovenian: To kaže na pomemben delež velike odpornosti, čeprav ni bila določena še nobena zanesljiva klinična mejna vrednost.
English: The recommended dosage rates are:
Slovenian: Priporočeni odmerki: