natgillin/translations-raw huggingface dataset:
SPECIAL STORAGE CONDITIONS Do not store above 25 °C. 
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 25 °C.
Laboratory studies in dogs and rats have not produced any evidence of reproductive, foetotoxic or teratogenic effects for lincomycin or spectinomycin. 
Z laboratorijskimi študijami na pseh in podganah niso bili dokazani učinki linkomicina ali spektinomicina na razmnoževanje, niti njuni fetotoksični ali teratogeni učinki.
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: 
Po splošni oceni v sklopu usklajenosti že odobrenega zdravila in na podlagi spodaj navedenih razlogov je odbor CVMP menil, da se lahko odmerjanje 50 mg/kg telesne mase 7 dni sprejme kot usklajeni odmerek pri piščancih:
Use of the veterinary medicinal product deviating from the instructions in the SPC may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with macrolides due to the potential for cross-resistance. 
Uporaba zdravila za uporabo v veterinarski medicini, ki ni v skladu z navodili v SmPC-ju lahko poveča tveganje za razvoj in selekcijo odpornih bakterij in zmanjša učinkovitost zdravljenja z makrolidi zaradi možnosti nastanka navzkrižne odpornosti.
It is known from the pharmacokinetic properties of spectinomycin that only negligible amounts are absorbed from the gut and that in any case, blood levels do not reach MIC concentrations within the respiratory tract of chickens after oral administration; in addition, spectinomycin is polar and does not readily cross membranes and distribute into the intracellular compartment. 
Na podlagi farmakokinetičnih lastnosti spektinomicina je znano, da se iz črevesa absorbirajo samo zanemarljive količine in da v kakršnem koli primeru ravni v krvi ne dosežejo koncentracij MIK v dihalih piščancev po peroralni uporabi; poleg tega je spektinomicin polaren in ne prehaja zlahka skozi membrane ter se ne porazdeli zlahka v notranjost celic.
The withdrawal time is supported by a study where chickens were treated at 500 mg/kg bw during their first week of life and at 60 mg/kg during their third week of life; depletion follow-up was conducted only after the second phase. 
Karenco podpira študija, v kateri so piščance zdravili z odmerki 500 mg/kg telesne mase v prvem tednu življenja in 60 mg/kg telesne mase v tretjem tednu življenja; sledenje izločanja je bilo izvedeno šele po drugi fazi.
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. 
Vendar natančna klinična mejna vrednost ni bila določena in na podlagi predloženih podatkov je videti, da občutljivost in vitro ni bila povezana s klinično učinkovitostjo.
LincoSpectin 100 prašek za peroralno raztopino za prašiče in perutnino 
Linco Spectin 100 prašek za peroralno raztopino za prašiče in perutnino
Furthermore, in addition to old experimental and field clinical efficacy studies, a recent proprietary challenge study was presented, where a total of 210 chickens were used to test efficacy of the product against induced E. coli and/or M. gallisepticum infection. 
Poleg starih eksperimentalnih študij in kliničnih študij učinkovitosti na terenu je bila predložena nedavna lastniška provokacijska študija, v kateri so uporabili 210 piščancev, da bi preverili učinkovitost zdravila proti sproženi okužbi z E. coli in/ali M. gallisepticum.
In addition efficacy might be influenced by the conditions established in the gut by various associated enteric bacteria. 
Poleg tega lahko na učinkovitost vplivajo pogoji, ki jih v črevesju vzpostavijo različne sorodne enterične bakterije.
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. 
V tej študiji je bil razpon MIK od 4 : 8 µg/ml do ≥ 256 : 512, z velikimi vrednostmi MIC90 > 256 µg/ml za spektinomicin in navidezno bimodalno porazdelitvijo.
In a GLP challenge study, pigs were treated with the recommended 10 mg/kg bw dose, but for 21 days instead of 7 days. 
V provokacijski študiji v skladu z DLP so prašiče zdravili s priporočenim odmerkom 10 mg/kg telesne mase, vendar je zdravljenje namesto 7 dni trajalo 21 dni.
People with known hypersensitivity to lincomycin, spectinomycin or soybean millfeed should avoid contact with the veterinary medicinal product. 
Osebe z znano preobčutljivostjo na linkomicin, spektinomicin ali sojina krmila se morajo izogibati stiku z zdravilom za uporabo v veterinarski medicini.
Do not use in case of hepatic dysfunction. 
Ne uporabite v primeru okvare jeter.
Thus, it is unclear as to the value of a combination product for this indication versus a monotherapy product (e.g. lincomycin). 
Posledično vrednost kombiniranega zdravila za to indikacijo v primerjavi z monoterapijo (npr. z linkomicinom) ni jasna.
In case of disease accompanied with significant decrease in water intake, parenteral treatment may have to be initiated. 
V primeru bolezni, pri kateri pride do izrazitega padca dnevno popite vode je treba uvesti parenteralno zdravljenje.
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. 
Vendar so bili uporabljeni režimi odmerjanja zelo nejasni, njihov razpon pa je bil verjetno od predlaganega odmerka 50 mg/kg telesne mase/dan do največjega odobrenega odmerka 150 mg/kg telesne mase.
Store in a dry place. 
Shranjujte na suhem mestu.
Lincomycin may lead to severe gastrointestinal disturbances in other animal species. 
Linkomicin lahko povzroči resne motnje v delovanju želodca in črevesja pri drugih živalskih vrstah.
The most frequent dosing recommendation for treatment is 50 mg/kg bw/day; few SPCs recommend 150 mg/kg bw and some other ones give only a concentration in water, which corresponds approximately to 50 mg/kg bw. 
Najpogostejše priporočilo za odmerjanje pri zdravljenju je 50 mg/kg telesne mase/dan; nekaj povzetkov glavnih značilnosti zdravila priporoča odmerek 150 mg/kg telesne mase, drugi pa navajajo samo koncentracijo v vodi, ki je enaka približno 50 mg/kg telesne mase.
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. 
V podporo indikaciji za proliferativno enteropatijo, ki jo povzroča Lawsonia intracellularis, so se predložili pregled literature s podatki o občutljivosti in vitro in dve starejši klinični študiji učinkovitosti.
Lincomycin pharmacokinetic studies in pigs show that lincomycin is bioavailable when given intravenously, intramuscularly or orally. 
Farmakokinetične študije kažejo, da je linkomicin pri prašičih biološko razpoložljiv po intravenskem, intramuskularnem ali peroralnem dajanju.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal. 
Dobra klinična praksa temelji na preskušanju občutljivosti bakterij, ki se jih izolira iz živali.
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, or on effects of metabolite(s). 
Mehanizem, s katerim spektinomicin ob peroralnem dajanju, kljub slabi absorbciji deluje na patogene mikrobe na sistemski ravni, ni povsem pojasnjen in je lahko deloma odvisen od neposrednih učinkov na črevesno floro ali od učinkov metabolita(ov).
Tolerance is still adequately reflected by the harmonised texts for SPC sections 4.5 (i) Special precautions for use in animals, 4.6 Adverse reactions (frequency and seriousness) and 4.10 Overdose. 
Usklajena besedila povzetka glavnih značilnosti zdravila v poglavjih 4.5 (i) Posebni previdnostni ukrepi za uporabo pri živalih, 4.6 Neželeni učinki (pogostost in resnost) in 4.10 Preveliko odmerjanje so še vedno zadostna glede tolerance.
Additionally, the long-term use of the product and the absence of reported lack of efficacy in the pharmacovigilance data have been noted. 
Poleg tega so v farmakovigilančnih podatkih ugotovili dolgotrajno uporabo zdravila in odsotnost poročanja o pomanjkanju učinkovitosti.
However, the most prevalent mechanism in B. hyodysenteriae and mycoplasmas is the alteration of the binding site through mutational events (chromosomal resistance). 
Najbolj razširjen mehanizem pri B. Hyodysenteriae in mikoplazmah je sprememba mesta vezave zaradi mutacij (kromosomska odpornost).
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. 
Klinično učinkovitost ob predlaganem režimu odmerjanja za prašičjo dizenterijo 10 mg/kg telesne mase 7 dni so podprli v dveh podvojenih preskušanjih pri laboratorijskih pogojih in dveh kliničnih študijah na terenu.
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. 
povezano z dejstvom, da lahko k patogenezi bolezni prispevajo različne črevesne bakterije, zato bi bilo treba učinkovitost dokazovati s sevi z relativno velikimi vrednostmi MIK zaradi velike lokalne koncentracije antibiotika v črevesu.
The indication for chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum and E. coli was supported by two recent MIC surveys and by older literature MIC data. 
Indikacija za kronično respiratorno bolezen (KRB), povezano z Mycoplasma gallisepticum in E. coli, je bila podprta z dvema nedavnima raziskavama MIK in podatki o MIK iz starejše literature.
Older field studies typically used a dose regimen of 150 mg/kg bw in a first phase followed by 50 mg/kg bw in a second phase; they were considered poorly relevant as they focus on systematic prophylaxis and zootechnical/economical endpoints. 
Starejše terenske študije so navadno v prvi fazi uporabile režim odmerjanja 150 mg/kg telesne mase, ki mu je v drugi fazi sledil režim odmerjanja 50 mg/kg telesne mase; te študije so malo pomembne, saj so se osredotočale na sistematsko profilakso in zootehnične/ekonomske opazovane dogodke.
Resistance against macrolides and lincosamides has emerged among animal pathogens and is common in some species. 
Pri živalskih patogenih se je pojavila odpornost proti makrolidom in linkozamidom, ki je pri nekaterih vrstah pogosta.
150 g of the veterinary medicinal product corresponds to the dose for 2,000 kg of body weight per day. 
150 g zdravila za uporabo v veterinarski medicini ustreza odmerku za 2000 kg telesne teže na dan.
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. 
Ker se spektinomicin slabo absorbira v prebavilih in ne prehaja zlahka skozi membrane, bi bila lahko njegova učinkovitost vsaj delno povezana z nespecifičnimi učinki na črevesno floro ali učinki presnovka.
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). 
Zdravilo Linco-Spectin 100 (in povezana imena) je prašek za dajanje v vodo za pitje, ki vsebuje zdravilni učinkovini linkomicin (222 mg/g) in spektinomicin (444,7 mg/g).
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali) - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
INDICATION(S) Read the package leaflet before use. 
INDIKACIJA(E) Pred uporabo preberite navodilo za uporabo.
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. 
Klinična učinkovitost proti proliferativni enteropatiji se je utemeljila z eno laboratorijsko študijo, skladno z DLP, in eno multicentrično terensko študijo, skladno z DKP, vendar so v laboratorijski študiji živali zdravili 21 dni.
Peak serum levels were observed at 4 hours after dosing. 
Najvišje vrednosti v serumu so opazili 4 ure po odmerjanju.
Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet 
Znanstveni zaključki in razlogi za spremembo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
MANUFACTURER'S BATCH NUMBER Lot: 
IZDELOVALČEVA ŠTEVILKA SERIJE
Despite the poor in vitro activity of the active substances against L. intracellularis, the combination might be effective due to combined intra- and extracellular action of lincomycin and spectinomycin, respectively. 
Kljub slabi učinkovitosti zdravilnih učinkovin in vitro proti L. intracellularis bi bila lahko kombinacija učinkovita zaradi kombiniranega znotraj- in zunajceličnega delovanja linkomicina oziroma spektinomicina.
Clinical efficacy in swine dysentery at a dosing regimen close to the recommended harmonised regimen of 10 mg/kg bw for 7 days is supported by older laboratory and field clinical studies, despite the fact that these are not GLP or GCP-compliant and that the clinical and bacteriological criteria for inclusion are not always precisely defined in the study reports. 
Klinično učinkovitost proti prašičji dizenteriji ob režimu odmerjanja, ki je blizu priporočenemu usklajenemu režimu 10 mg/kg telesne mase 7 dni, so podprle starejše laboratorijske in terenske klinične študije, čeprav niso bile skladne z DLP ter DKP in čeprav klinična in bakteriološka merila za vključevanje niso vedno natančno opredeljena v poročilih študij.
10 DATE OF REVISION OF THE TEXT To be completed nationally. 
DATUM REVIZIJE BESEDILA Podatke je treba dopolniti v posameznih državah.
The activity spectrum of spectinomycin includes mycoplasmas, aerobic gramnegative bacteria, and gram-positive cocci. 
Spekter učinkovitosti spektinomicina vključuje mikoplazme, aerobne gramnegativne bakterije in grampozitivne koke.
Spectinomycinum (ut Spectinomycini sulfas tetrahydricus) 
Spectinomycinum (ut Spectinomycini sulphas tetrahydricus)
The proposed withdrawal time of 5 days is considered sufficient by the CVMP when chickens are treated using the proposed harmonised dosing regimen 50 mg/kg bw/day for 7 days. 
Odbor CVMP je menil, da je predlagana karenca 5 dni zadostna, kadar se piščanci zdravijo s predlaganim usklajenim režimom odmerjanja 50 mg/kg telesne mase/dan 7 dni.
The indication for swine dysentery caused by Brachyspira hyodysenteriae and associated pathogens was substantiated trough a review of literature and old proprietary in vitro susceptibility data, a newly conducted B. hyodysenteriae MIC survey, and old clinical studies. 
Indikacija za prašičjo dizenterijo, ki jo povzroča Brachyspira hyodysenteriae in povezani patogeni, je bila utemeljena s pregledom literature ter starih lastniških podatkov o občutljivosti in vitro, novo raziskavo MIK za B. hyodysenteriae in starimi kliničnimi študijami.
In chickens treated with “product name (to be completed nationally)” in drinking water at the target dose of 50 mg/kg body weight of total activity (at a ratio of 1:2 lincomycin:spectinomycin) for seven consecutive days, Cmax after first offering of medicated water was calculated to be 0.0631 µg/ml. 
Pri piščancih, ki so jim “ime zdravila (podatke je treba dopolniti v posameznih državah)” dajali v odmerku 50 mg/kg telesne teže v vodo za pitje sedem dni zaporedoma (v razmerju 1:2, linkomicin:spektinomicin) je bila Cmax po prvem dajanju medicirane vode 0,0631 µg/ml.
Wash hands and any exposed skin with soap and water immediately after use. 
Takoj po uporabi si z milom in vodo umijte roke in izpostavljene dele kože.
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. 
Na podlagi preiskav in vitro je bila postavljena hipoteza, da se v črevesu tvori presnovek ali produkt razgradnje spektinomicina, ki doseže mesto okužbe in ovira priraščanje E. coli na sluznico dihal, vendar to ni bilo validirano (Goren in sod.
Shelf life of the veterinary medicinal product as packaged for sale: “to be completed nationally”. 
Rok uporabnosti zdravila v pakiranju za prodajo: “podatke je treba dopolniti v posameznih državah”.
The proposed withdrawal time of 0 days was well supported by a residue study where pigs were treated using the proposed harmonised dosing regimen 10 mg/kg bw/day for 7 days, and is considered acceptable by the CVMP. 
Predlagana karenca 0 dni je bila dobro podprta s študijami ostankov, v katerih so se prašiči zdravili s predlaganim usklajenim režimom odmerjanja 10 mg/kg telesne mase/dan 7 dni, kar je sprejemljivo za odbor CVMP.
The repeated or prolonged use should be avoided, by improving the farm management and disinfection practices. 
Z izboljšanim upravljanjem kmetije in z izboljšanjem navad glede dezinfekcije se je treba izogniti ponavljajoči in podaljšani uporabi zdravila.
A single oral administration of lincomycin hydrochloride, at dose levels of approximately 22, 55 and 100 mg/kg body weight in pigs, resulted in dose related lincomycin serum levels, detected for 24-36 hours after administration. 
Po enkratnem peroralnem dajanju linkomicinijevega klorida v odmerkih po približno 22, 55 in100 mg/kg/telesne teže prašičem, so v serumu še 24-36 ur po dajanju izmerili vrednosti linkomicina, ki so bile odvisne od velikosti odmerka.
In Brachyspira hyodysenteriae nearly all isolates are resistant at least regarding the wild-type in vitro susceptibility. 
Pri Brachyspira hyodysenteriae so bili skoraj vsi izolati odporni, predvsem glede občutljivosti divjih tipov in vitro.
Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp. 
Spektinomicin spada med aminociklitole in je proizvod bakterije Streptomyces spectabilis, deluje bakteriostatično, deluje proti Mycoplasma spp.
Use of the product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to lincomycin and spectinomycin and may decrease the effectiveness of treatment with other antimicrobials of the same or related classes, due to the potential for cross resistance. 
Uporaba zdravila, ki ni v skladu z navodili v povzetku glavnih značilnosti zdravila, lahko poveča tveganje za razvoj in selekcijo odpornih bakterij in zmanjša učinkovitost zdravljenja z drugimi protimikrobnimi zdravili iz istega ali sorodnega razreda zaradi možnosti nastanka navzkrižne odpornosti.
There is no established clinical breakpoint. 
Klinična mejna vrednost ni določena.
For those reasons, despite that the available data show no negative evolution over time, it could not be excluded that the results obtained in the old clinical studies conducted at the time of product development do not reflect clinical efficacy in modern outbreaks of swine dysentery. 
Čeprav razpoložljivi podatki ne kažejo negativne evolucije v času, pa zaradi zgornjih razlogov ni mogoče izključiti, da rezultati iz starih kliničnih študij, izvedenih v času razvoja zdravila, ne odražajo klinične učinkovitosti pri sodobnih izbruhih prašičje dizenterije.
Pigs: 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days. 
Prašiči: 3,33 mg linkomicina in 6,67 mg spektinomicina/kg telesne teže/dan, za čas zdravljenja 7 dni.
For E. coli, a newly conducted pan-European MIC survey, involving 67 chicken isolates and 33 turkey isolates, showed a wide MIC range (from 2:4 to ≥256:512 µg/ml), a high spectinomycin MIC90 (256 µg/ml) and a bimodal distribution. 
Nova panevropska raziskava MIK za E. coli, ki je vključila 67 izolatov iz piščancev in 33 izolatov iz puranov, je pokazala širok razpon MIK (od 2 : 4 do ≥ 256 : 512 µg/ml), veliko vrednost MIK90 za spektinomicin (256 µg/ml) in bimodalno porazdelitev.
In general mixture with other medicines should be avoided. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Mešanju z drugimi zdravili se je treba praviloma izogibati.
This could be due to combined intra- and extracellular action of lincomycin and spectinomycin, respectively. 
To je lahko posledica kombiniranega znotrajin zunajceličnega delovanja linkomicina oziroma spektinomicina.
Spectinomycin is classified as an aminocyclitol antibiotic, close to aminoglycosides; it inhibits protein synthesis by binding to the 30S ribosomal subunit. 
Spektinomicin je razvrščen kot aminociklitolni antibiotik, soroden aminoglikozidom; zavira sintezo beljakovin, tako da se veže na ribosomsko podenoto 30S.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Pigs and chickens. 
Prašiči in piščanci.
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. 
Zdravljenje z zdravilom Linco-Spectin 100, ki je trajalo 7 in 14 dni, je bilo učinkovito proti ileitisu pri prašičih; zdravljenje prašičev z ileitisom več kot 7 dni ni bilo koristno.
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 preskušati in vitro in podatki o odpornosti pri teh vrstah so pomanjkljivi.
Chicken 
Piščanci
Spectinomycin is poorly absorbed by the gastro-intestinal tract and does not easily cross membranes. 
Spektinomicin se slabo absorbira v prebavilih in slabo prehaja skozi membrane.
Do not use in birds in lay. 
Ne uporabite pri pticah v obdobju nesnosti.
In chickens, in order to reflect the fact that in the only study formally demonstrating efficacy of the 50 mg/kg dose against CRD clinical signs and lesions, the challenge was mild to moderate with no mortality recorded, it is proposed to amend the indication as follows: 
Ker je bila v edini študiji na piščancih, ki je uradno dokazala učinkovitost odmerka 50 mg/kg proti kliničnim znakom in lezijam KRB, provokacija blaga do zmerna in brez umrljivosti, je odbor predlagal naslednjo spremembo indikacije: