natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
The table below shows the volume of water to be used for dilution of 150 g of the veterinary medicinal product.
Spodnja tabela prikazuje volumen vode, ki se uporabi, da se raztopi 150 g zdravila za uporabo v veterinarski medicini.
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.
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.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substances:
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN Zdravilne učinkovine:
Chromosomal one-step mutation to high-level spectinomycin resistance develops in many enteric bacteria (such as E. coli).
Mutacija kromosoma v enem koraku, ki povzroči visoko stopnjo odpornosti na spektinomicin se razvije pri mnogih črevesnih bakterijah (kot je E. coli).
Pharmacovigilance reports have not reported a lack of efficacy of Linco-Spectin 100 in the recommended harmonised indications in pigs.
Farmakovigilančna poročila niso poročala o pomanjkanju učinkovitosti zdravila Linco-Spectin 100 pri priporočenih usklajenih indikacijah pri prašičih.
This reflects the ready acquisition of resistance determinants by the bacterium.
To kaže na pripravljenost bakterije za pridobitev determinant odpornosti.
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.
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.
Plasmid-mediated resistance is less common.
Odpornost, ki se prenese preko plazmidov je manj pogosta.
This is indicative of a significant rate of high-level resistance although no firm clinical breakpoint has been set.
To kaže na pomemben delež velike odpornosti, čeprav ni bila določena še nobena zanesljiva klinična mejna vrednost.
The recommended dosage rates are:
Priporočeni odmerki:
Lincomycin binds to the 50S sub-unit of the bacterial ribosome close to the peptidyl transfer centre and interferes with the peptide chain elongation process by inhibiting the formation of the 50S sub-unit and by stimulating ribosomal peptidyl-tRNA dissociation.
Linkomicin se veže na podenoto 50 S bakterijskega ribosoma, v bližino centra peptidil-transferaze in prepreči proces podaljševanja peptidne verige tako, da zavira nastajanje podenote 50 S in vzpodbudja odcepitev ribosomske peptidil-tRNA.
* A dose of 50 mg/kg bw is the most frequent recommendation for “treatment” among the concerned SPCs.
• odmerek 50 mg/kg telesne mase je najpogostejše priporočilo za »zdravljenje« v zadevnih povzetkih glavnih značilnosti zdravila.
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.
Če se po stiku z zdravilom pojavi kožni izpuščaj ali trajno draženje oči, takoj poiščite medicinsko pomoč in pokažite navodilo za uporabo ali ovojnino zdravniku.
It is speculated by the marketing authorisation holder that spectinomycin might have an effect on associated pathogens related to swine dysentery; however, such an effect has not been formally demonstrated in vivo on specific pathogens.
Imetnik dovoljenja za promet z zdravilom meni, da bi spektinomicin lahko imel učinek na sorodne patogene, povezane s prašičjo dizenterijo, vendar takega učinka niso uradno dokazali na specifičnih patogenih in vivo.
Taking into account all data, the CVMP considered that this indication can be accepted.
Upoštevajoč vse podatke je odbor CHMP menil, da je ta indikacija sprejemljiva.
Pringle et al. (2012)1 have proposed an epidemiological cut-off of >1 μg/ml for lincomycin, with which 90 to 100% of the isolates are classified as “resistant in vitro”.
(2012)1 so predlagali epidemiološko mejno vrednost > 1 μg/ml za linkomicin, pri kateri je od 90 do 100 % izolatov razvrščenih kot »odpornih in vitro«.
Lincomycin distributes well into tissues and is known to produce high intracellular concentrations.
Linkomicin se dobro porazdeli v tkivih in znano je, da tvori velike koncentracije v celicah.
“Product name (to be completed nationally)” is a combination of two antibiotics, lincomycin and spectinomycin, having a complementary spectrum of activity.
“Ime zdravila (podatke je treba dopolniti v posameznih državah)” je kombinacija dveh antibiotikov, linkomicina in spektinomicina, ki delujeta komplementarno.
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.
Čeprav redki razpoložljivi podatki kažejo, da je delovanje zdravilne učinkovine in vitro proti L. intracellularis slabo, je mogoče na podlagi dobro uveljavljene uporabe zdravila v EU in dejstva, da farmakovigilančna poročila ne kažejo pomanjkanja učinkovitosti, sklepati, da klinične okoliščine niso neposredno povezane s klinično učinkovitostjo zdravila.
Since the dosing regimens recommended by the CVMP have not been increased, and the indications have not been extended with regard to those approved in most SPCs, the assessment of the tolerance in the target species does not present new issues.
Ker odbor CVMP ni povečal priporočil za režime odmerjanja in se indikacije niso razširile glede na indikacije, odobrene v večini povzetkov glavnih značilnosti zdravila, se pri oceni tolerance pri ciljnih živalskih vrstah niso pojavile nove težave.
The results of the literature MIC data, which concern only a few isolates, overall indicate high MIC values for both lincomycin and spectinomycin.
Splošni rezultati pregleda podatkov o MIK iz literature, ki se nanašajo samo na nekaj izolatov, kažejo na velike vrednosti MIK za linkomicin in spektinomicin.
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.