FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination might have a synergistic effect in Mycoplasma, but the clinical significance of this was not investigated.
Croatian: Kombinacija može imati sinergijsko djelovanje u bakterija Mycoplasma, no klinički značaj nije istražen.
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.
Croatian: CVMP je preporučio izmjenu odobrenja za stavljanje VMP-a u promet za Linco-Spectin 100 i njegove povezane nazive kako je navedeno u Prilogu I., za koji VMP su sažetak opisa svojstava VMP-a, etiketa i uputa o VMP-u navedeni u Prilogu III.
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
Croatian: Perad: za primjenu putem vode za piće kao jedini izvor pitke vode dok se ne popije, nakon toga ako je potrebno do kraja dana davati vodu bez medicinskih dodataka.
English: - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: - vrlo rijetke (manje od 1 životinje na 10 000 životinja, uključujući izolirane slučajeve).
English: On the basis of in vitro tests, it has been hypothesised that a metabolite or degradation product of spectinomycin was produced in the gut and was able to reach the infection site and interfere with E. coli adherence to the respiratory mucosa, but this has not been validated (Goren et al., 1988)2.
Croatian: Na temelju in vitro testova postavljena je hipoteza da je metabolit ili proizvod razgradnje spektinomicina proizveden u crijevima, te da je dosegnuo mjesto infekcije i da interferira s prianjanjem bakterije E. coli na respiratornu sluznicu, no ova hipoteza nije potvrđena (Goren et al., 1988)2.
English: Direct benefits
Croatian: Izravne koristi
English: Indirect benefits
Croatian: Indirektne koristi
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.
Croatian: Proizvod se koristi u predloženim indikacijama (svinjska dizenterija i proliferativna enteropatija) tijekom nekoliko desetljeća u mnogim državama članicama EU-a, na temelju komplementarnog spektra djelovanja linkomicina i spektinomicin na primarne patogene B. hyodysenteriae i L. intracellularis, te potencijalno povezane crijevne patogene kao što je E. coli.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrijebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s propisima o zbrinjavanju otpada.
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.
Croatian: Stoga je CVMP zaključio da treba zadržati indikaciju u pilića, no potrebno ju je prilagoditi kako slijedi: „Za liječenje i prevenciju KRB-a uzrokovanog bakterijama Mycoplasma gallisepticum i E. coli, povezanima s niskom stopom smrtnosti.
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.
Croatian: U pilića je proizvod već indiciran u mnogim državama članicama za liječenje KRB-a kojeg uzrokuje Mycoplasma i/ili E. coli.
English: Taking into account all data, the CVMP considered that this indication can be maintained.
Croatian: Uzimajući u obzir sve podatke, CVMP smatra da se ova indikacija može zadržati.
English: Spectinomycin has no significant clinical effect on B. hyodysenteriae.
Croatian: Spektinomicin nema značajno kliničko djelovanje na B. hyodysenteriae.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Croatian: Neškodljivost VMP-a nije utvrđena za vrijeme graviditeta i laktacije.
English: In a GCP-compliant, multicentre field study, pigs were treated as recommended and medication with Linco-Spectin 100 for 7 and 14 days was efficacious for the treatment of ileitis in pigs; there was no benefit of treating pigs suffering from ileitis longer than 7 days.
Croatian: U slučaju multicentričnog terenskog ispitivanja sukladnog DLP-u, svinje su liječene na temelju preporuka, a liječenje VMP-om Linco-Spectin 100 tijekom 7 i 14 dana bilo je djelotvorno za liječenje ileitisa u svinja; nisu utvrđene koristi od liječenja svinja koje su bolovale od ileitisa dulje od 7 dana.
English: Thus, it is unclear as to the value of a combination product for this indication versus a monotherapy product (e.g. lincomycin).
Croatian: Stoga, nije jasna vrijednost kombiniranog VMP-a za ovu indikaciju u usporedbi s monoterapijskim VMP-om (primjerice linkomicinom).
English: Shelf life of the veterinary medicinal product as packaged for sale: “to be completed nationally”.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: “biti će dovršeno na nacionalnoj razini”
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.
Croatian: Literatura i stari vlasnički podaci o in vitro osjetljivosti potvrđuju da je raspon ukupne minimalne inhibitorske koncentracije linkomicina za B. hyodysenteriae vrlo širok, a populacijske vrijednosti za MIC50 i MIC90 vrlo su visoke.
English: Zoetis Hellas SA L. Mesogion 253- 255 15451, N. Psichico Athens
Croatian: Mesogion 253- 255 15451, N.
English: Overall and considering also the older literature data, a rate of clinical resistance of at least 10% was suggested.
Croatian: Općenito, i uzimajući u obzir starije podatke iz literature, predložena je stopa kliničke rezistencije od najmanje 10%, što može biti rezultat i djelomično prirodne otpornosti.
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;
Croatian: • čini se da su svi autori suglasni kako postoji raširena rezistencija bakterije B. hyodysenteriae na linkomicin, iako nema dostupne kliničke prijelomnice, te nije poznato u kojoj su mjeri sojevi s povišenim MIC-ovima klinički rezistentni;
English: The oral absorption of lincomycin was found to be 53% ± 19%.
Croatian: Resorpcija nakon primjene kroz usta bila je 53 ±19%.
English: Plasmid-mediated resistance is less common.
Croatian: Rezistencija posredovana plazmidima je manje česta.
English: Pregnancy and lactation:
Croatian: Graviditet i laktacija: Svinje:
English: It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal.
Croatian: U skladu s dobrom kliničkom praksom liječenje treba temeljiti na testu osjetljivosti bakterija izoliranih iz životinja.
English: Taking into account all data, the CVMP considered that this indication can be accepted.
Croatian: Uzimajući u obzir sve podatke, mišljenje je CVMP-a da se ova indikacija može prihvatiti.
English: Sick animals have a reduced appetite and an altered drinking pattern, and severely affected animals may therefore require parenteral treatment.
Croatian: Bolesne životinje imaju smanjeni apetit i promijenjenu potrebu za unosom vode, te stoga teško bolesne životinje treba liječiti parenteralno.
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.
Croatian: Također ciljni uvjet u jednom terenskom ispitivanju bila je kombinirana crijevna i respiratorna infekcija koja je obuhvaćala sojeve Salmonella i Mycoplasma, što nije značajno povezano s traženom indikacijom.
English: In Brachyspira hyodysenteriae nearly all isolates are resistant at least regarding the wild-type in vitro susceptibility.
Croatian: U Brachyspira hyodysenteriae gotovo su svi izolati rezistentni barem u vezi s divljim tipom in vitro osjetljivosti.
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.
Croatian: Provedena su starija ispitivanja u kontekstu sistemske profilakse i korišteni su dvofazni režimi doziranja; uvjeti ovih ispitivanja nisu poduprijeli predloženu dozu od 50 mg/kg tjelesne težine.
English: Excipients: For the full list of excipients, see section 6.1.
Croatian: Pomoćne tvari: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: The combination of lincosamides and macrolides is antagonistic, due to competitive binding to their target sites.
Croatian: Linkozamidi djeluju antagonistički na makrolide i obrnuto, zbog kompeticije prilikom vezanja na ciljna mjesta.
English: 1348 Louvain-la-Neuve Belgium
Croatian: 1348 Louvain-la-Neuve Belgija
English: PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally.
Croatian: ZABRANA PRODAJE, OPSKRBE I/ILI PRIMJENE
English: PACKAGE SIZE
Croatian: 4. VELIČINA PAKOVANJA
English: After an overall assessment in the context of the harmonisation of an already approved product, and for the reasons listed below, the CVMP considered that 50 mg/kg bw for 7 days can be accepted as the harmonised dose in chickens:
Croatian: Nakon cjelokupne ocjene u kontekstu usklađivanja već odobrenog proizvoda, te zbog razloga koji su navedeni niže u tekstu, CVMP smatra da se doza od 50 mg/kg tjelesne težine tijekom 7-dnevne primjene može prihvatiti kao usklađena doza u pilića:
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.
Croatian: Podaci o in vitro osjetljivosti za sojeve Escherichia coli i Salmonella nisu dovoljno iscrpni, no sadržavali su podatke iz novo provedene dobre laboratorijske prakse (DLP) koja je u skladu s paneuropskim MIC ispitivanjem koje je obuhvatilo 100 izolata E. coli i 100 izolata Salmonella iz kliničkih slučajeva.
English: Laboratory studies in dogs and rats have not produced any evidence of reproductive, foetotoxic or teratogenic effects for lincomycin or spectinomycin.
Croatian: Laboratorijskim pokusima na psima i štakorima nisu dokazani reproduktivni, fetotoksični ili teratogeni učinci likomicina ili spektinomicina.
English: Studies performed in various animal species have demonstrated that spectinomycin undergoes limited absorption from the intestine (less than 4-7%) after oral administration.
Croatian: Pokusi provedeni na različitim životinjskim vrstama su pokazali da je resorpcija spektinomicina iz crijeva, nakon primjene kroz usta, ograničena (manje od 4-7%).
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.
Croatian: Ova ispitivanja nisu bila u skladu s dobrim laboratorijskim praksama niti dobrim kliničkim praksama, a ciljni klinički i bakteriološki uvjeti nisu bili dobro definirani u izvješćima o ispitivanjima.
English: Similar results were observed following single oral doses of 4.4 and 11.0 mg/kg body weight in pigs.
Croatian: Slični rezultati su bili i nakon jednokratne primjene doze 4,4 i 11,0 mg/kg tjelesne mase svinjama kroz usta.
English: Although the scarce data available indicates that in vitro activity of the active substances against L. intracellularis is poor, considering the well-established use of the product in the EU and that the pharmacovigilance reports do not show any reports for lack of efficacy, it can be argued that the clinical situation is not directly correlated with the clinical efficacy of the product.
Croatian: Iako dostupni ograničeni podaci ukazuju da je in vitro djelovanje djelatne tvari protiv L. intracellularis slabo, uzimajući u obzir dobro utvrđenu primjenu proizvoda u EU-u te da farmakoviligancijska izvješća ne dokazuju da bilo kojem od izvješća nedostaje djelotvornosti, može se argumentirati da klinička situacija ne korelira izravno s kliničkom djelotvornošću proizvoda.
English: Pharmacovigilance reports have not reported a lack of efficacy of Linco-Spectin 100 in the recommended harmonised indications in pigs.
Croatian: Farmakovigilancijska izvješća nisu prijavila nedostatak djelotvornosti VMP-a Linco-Spectin 100 u slučaju preporučenih usklađenih indikacija u svinja.
English: Romania Pfizer Animal Health MA EEIG
Croatian: Rumunjska Pfizer Animal Health MA EEIG
English: Annex III
Croatian: DODATAK III
English: In addition efficacy might be influenced by the conditions established in the gut by various associated enteric bacteria.
Croatian: Nadalje, na djelotvornost mogu utjecati stanja utvrđena u crijevima drugih povezanih crijevnih bakterija.
English: If symptoms such as skin rash or persistent eye irritation appear after exposure, seek medical advice immediately and show the package leaflet or label to the physician.
Croatian: Ako se nakon izlaganja VMP-u pojave simptomi, kao što je osip ili dugotrajni nadražaj očiju, odmah treba potražiti pomoć liječnika i pokazati mu uputu o VMP-u ili etiketu.
English: Pharmacovigilance reports have not reported a lack of efficacy of Linco-Spectin 100 in the proposed harmonised indication in chicken.
Croatian: Farmakovigilancijska izvješća nisu prijavila nedostatak djelotvornosti VMP-a Linco-Spectin 100 u predloženoj usklađenoj indikaciji u pilića.
English: The activity spectrum of spectinomycin includes mycoplasmas, aerobic gramnegative bacteria, and gram-positive cocci.
Croatian: Spektar djelovanja spektinomicina uključuje mikoplazme, aerobne gram-negativne bakterije i gram-pozitivne koke.
English: Linco-Spectin 100 (and associated names) is a powder for use in drinking water containing the active substances lincomycin (222 mg/g) and spectinomycin (444.7 mg/g).
Croatian: Linco-Spectin 100 (i povezani nazivi) je prašak za primjenu u vodi za piće koji sadrži djelatne tvari linkomicin (222 mg/g) i spektinomicin (444.7 mg/g).
English: Peak serum levels were observed at 4 hours after dosing.
Croatian: Najveće koncentracije u serumu uočene su 4 sata nakon primjene.
English: In a GLP challenge study, pigs were treated with the recommended 10 mg/kg bw dose, but for 21 days instead of 7 days.
Croatian: U ispitivanju provokacije sukladno DLP-u, svinje su liječene preporučenom dozom od 10 mg/kg tjelesne težine, no tijekom 21 dana umjesto 7 dana.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottles containing 150 g or 1.5 kg and tub containing 4.5 kg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Boce s 150 g ili 1,5 kg i spremnik s 4,5 kg
English: Chromosomal one-step mutation to high-level spectinomycin resistance develops in many enteric bacteria (such as E. coli).
Croatian: Mutacija kromosoma u jednom koraku, koja dovodi do visokog stupnja rezistencije na spektinomicin, pojavljuje se u mnogih crijevnih bakterija (kao što je E. coli).
English: The medicated drinking water should be the sole source of drinking water for the treatment duration.
Croatian: Voda s otopljenim VMP-om treba biti jedini izvor pitke vode za vrijeme liječenja.
English: Cmax occurred at 4 hours after introduction of the medicated water.
Croatian: Cmax je utvrđena 4 sata nakon početka primjene vode s VMPom.
English: As spectinomycin is poorly absorbed by the gastro-intestinal tract and does not readily cross membranes, its efficacy might relate at least partly to non-specific effects on the gut flora or to the effects of a metabolite.
Croatian: Budući da se spektinomicin slabo apsorbira u gastrointestinalnom traktu i ne prolazi kroz membrane, njegova se djelotvornost može povezati s barem djelomičnim do nespecifičnim djelovanjem na crijevnu floru ili na djelovanje metabolita.
English: The discrepancy might be related to the fact that various enteric bacteria may contribute to the pathogenesis of the disease, and efficacy could be obtained in strains with relatively high MIC values due to high local antimicrobial concentration in the gut.
Croatian: različite crijevne bakterije mogu doprinijeti patogenezi bolesti, a djelotvornost se može dobiti u sojevima s relativno visokim MIC vrijednostima uslijed visoke lokalne antimikrobne koncentracije u crijevima.
English: The oral use of preparations containing lincomycin is only indicated in swine and chickens.
Croatian: Primjena kroz usta VMP-a koji sadržavaju linkomicin indicirana je samo u svinja i kokoši.
English: Risk assessment
Croatian: Ocjena rizika
English: However, no precise clinical breakpoint has been established and from the data provided it seems that in vitro susceptibility was not correlated to clinical efficacy.
Croatian: No, nije utvrđena precizna klinička prijelomnica, te se na temelju dostavljenih podataka čini da in vitro osjetljivost nije u korelaciji s kliničkom djelotvornošću.
English: In this study the MIC range was from 4:8 µg/ml up to ≥256:512, with high MIC90 values of >256 µg/ml for spectinomycin, and a seemingly bimodal distribution.
Croatian: U ovom ispitivanju raspon MIC-a bio je od 4:8 µg/ml do ≥256:512, s visokim vrijednostima MIC90 od >256 µg/ml za spektinomicin i naizgled bimodalnom distribucijom.
English: This powder is for use in drinking water only and should be dissolved before use.
Croatian: Ovaj prašak je namijenjen za primjenu u vodi za piće i prije primjene ga treba otopiti.
English: The presence of the disease in the flock must be established before the product is used.”
Croatian: Prisutnost bolesti u jatu mora se utvrditi prije primjene proizvoda.”
English: Lincomycin and spectinomycin were shown to be more effective than each individual substance.
Croatian: Dokazano je da su linkomicin i spektinomicin djelotvorniji od svake zasebne tvari.
English: Levels were detectable for 12 to 16 hours, with peak concentrations occurring at 4 hours.
Croatian: Linkomicin se mogao otkriti tijekom 12 do 16 sati, uz najveću koncentraciju 4 sata nakon primjene.
English: Wash hands and any exposed skin with soap and water immediately after use.
Croatian: Neposredno nakon rada s VMP-om ruke i izložene dijelove kože treba oprati vodom i sapunom.
English: However, the used dosing regimens were very unclear and possibly range from the proposed dose of 50 mg/kg bw/day to the highest approved dose of 150 mg/kg bw.
Croatian: No, primijenjeni režimi doziranja bili su vrlo nejasni te je raspon mogao biti od predložene doze od 50 mg/kg tjelesne težine/dan do naviše odobrene doze 150 mg/kg tjelesne težine.
English: Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria (such as Brachyspira hyodysenteriae) and mycoplasmas.
Croatian: Linkomicin je učinkovit protiv gram-pozitivnih bakterija, nekih gram-negativnih anaerobnih bakterija (kao što je Brachyspira hyodysenteriae) i mikoplazmi.
English: Overall summary of the scientific evaluation of LincoSpectin 100 and its associated names (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene VMP-a Linco-Spectin 100 i povezanih naziva (vidjeti Prilog I.)
English: Clinical efficacy at the proposed dosing regimen of 10 mg/kg body weight (bw) for 7 days in swine dysentery was supported by two duplicate trials in laboratory conditions, and by two field clinical studies.
Croatian: Klinička djelotvornost u predloženom režimu doziranja od 10 mg/kg tjelesne težine tijekom 7 dana u slučaju svinjske dizenterije podržana je dvama dupliciranim istraživanjima u laboratorijskim uvjetima, te dvama terenskim kliničkim ispitivanjima.
English: Linco-Spectin 100 is a powder for oral solution containing 33.3 g lincomycin (as lincomycin hydrochloride) and 66.7 g spectinomycin (as spectinomycin sulphate) per 150 g pack.
Croatian: Linco-Spectin 100 je prašak za oralnu otopinu koji sadrži 33,3 g linkomicina (kao linkomicin-hidroklorid) i 66,7 g spektinomicina (kao spektinomicin-sulfat) u pakiranjima po 150 g.
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.
Croatian: Iako se za linkozamide općenito smatra da djeluju bakteriostatski, njihovo djelovanje ovisi o osjetljivosti mikroorganizama i koncentraciji antibiotika.
English: Hungary Zoetis Hungary Kft. Alkotás u. 53.
Croatian: Mađarska Zoetis Hungary Kft.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Croatian: Ako se zamijeti bilo koja ozbiljna nuspojava ili druge nuspojave koje nisu opisane u uputi o VMP-u, treba obavijestiti veterinara.
English: Literature data indicate that decreased susceptibility in B. hyodysenteriae could be overcome to some extent by the high concentrations attained locally.
Croatian: Podaci dostupni u literaturi ukazuju da se smanjena osjetljivost u slučaju B. hyodysenteriae može prevladati u određenoj mjeri velikim koncentracijama koje se primjenjuju lokalno.
English: The table below shows the volume of water to be used for dilution of 150 g of the veterinary medicinal product.
Croatian: Sljedeća tablica pokazuje volumen vode u kojem treba otopiti 150 g VMP-a.
English: In support of the indication for proliferative enteropathy caused by Lawsonia intracellularis, a literature review on in vitro susceptibility data was provided, as well as two older clinical efficacy studies.
Croatian: U prilog indikacije za proliferativnu enteropatiju uzrokovanu bakterijom Lawsonia intracellularis, dostavljen je pregled literature o podacima in vitro osjetljivosti, kao i dva starija ispitivanja kliničke djelotvornosti.
English: Annex I
Croatian: Prilog I
English: The recommended dosage rates are:
Croatian: Propisane doze:
English: People with known hypersensitivity to lincomycin, spectinomycin or soybean millfeed should avoid contact with the veterinary medicinal product.
Croatian: Osobe kojima je poznato da su preosjetljive na linkomicin ili spektinomicin trebaju izbjegavati kontakt s VMP-om.
English: Clinical efficacy against proliferative enteropathy is substantiated through one GLP laboratory study and one GCP multicenter field study, except that in the laboratory study the animals were treated for 21 days.
Croatian: Klinička djelotvornost protiv proliferativne enteropatije poduprijeta je jednim laboratorijskim ispitivanjem provedenim u skladu s DLP-om i jednim multicentričnim terenskim ispitivanjem provedenim u skladu s DKP-om, izuzetak predstavlja laboratorijsko ispitivanje kada su životinje bile liječene 21 dan.
English: Czech Republic
Croatian: Češka republika
English: Pigs: 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days.
Croatian: Svinje: 3,33 mg linkomicina i 6,67 mg spektinomicina/kg tjelesne mase dnevno, tijekom 7 dana.