natgillin/translations-raw huggingface dataset:
Upon comparison to more recent EU isolates (2011-2016), the MIC distributions are similar, being tri-modal with peaks differing by one doubling dilution at the most.
V primerjavi z novejšimi izolati v EU (2011-2016) so porazdelitve vrednosti MIK podobne in so trimodalne, pri čemer so vrhovi med seboj oddaljeni za največ dvakratno redčino.
The dosage of 3.9 mg/kg body weight was investigated in another two trials with similar designs, under simulated natural conditions.
Odmerjanje 3,9 mg/kg telesne mase so proučili v dveh preskušanjih s podobno zasnovo v simuliranih naravnih pogojih.
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Pri uporabi zdravila za uporabo v veterinarski medicini je treba upoštevati uradne, nacionalne in regionalne protimikrobne smernice.
However, in light of the fact that the lincomycin dose given in the study provided was several times higher than the recommended dose for Lincocin, and the duration of treatment was similar, it was considered that the available study provides a rather conservative result, even though the possibility of pharmacokinetic interactions between lincomycin and spectinomycin were not addressed.
Vendar je bilo glede na dejstvo, da je bil odmerek linkomicina, uporabljen v študiji, večkrat večji od priporočenega odmerka za zdravilo Lincocin ob podobnem trajanju zdravljenja, se je štelo, da razpoložljiva študija zagotavlja precej konzervativen rezultat, čeprav ni bila obravnavana možnost farmakokinetičnih interakcij med linkomicinom in spektinomicinom.
High concentrations of the active form are observed in the intestine.
V črevesju opazimo visoke koncentracije aktivne oblike.
Older studies, using microbiological methods, are available and indicate that a zero-day withdrawal period could be appropriate; however, these studies are not considered to have been conducted to current standards.
Na voljo so starejše študije z mikrobiološkimi metodami, ki kažejo, da bi lahko bila ustrezna karenca nič dni; vendar se šteje, da te študije niso bile izvedene v skladu s sedanjimi standardi.
In addition, older studies conducted with Lincocin in chickens, and in which a microbiological method was used to measure residues, provide further reassurance that a withdrawal period of 5 days is safe for consumers.
Poleg tega starejše raziskave, opravljene z zdravilom Lincocin pri piščancih, v katerih je bila uporabljena mikrobiološka metoda določanja ostankov, predstavljajo dodatno zagotovilo, da je petdnevna karenca varna za potrošnike.
Shelf life after dilution or reconstitution according to directions: 24 hours.
Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili: 24 ur.
Lincomycin may be either bactericidal or bacteriostatic.
Linkomcin lahko deluje baktericidno ali bakteriostatično.
Personal protective equipment consisting of approved dust masks (either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN140 with a filter EN143), gloves and safety glasses should be worn when handling and mixing the product.
Osebna zaščitna oprema mora vsebovati odobrene protiprašne maske (bodisi respirator za enkratno uporabo, ki ustreza evropskemu standardu EN149 ali respirator za enkratno uporabo, ki je skladen z evropskim standardom EN140 s filtrom EN143), rokavice in zaščitna očala med rokovanjem in mešanjem zdravila.
The risks associated with use of Lincocin and its associated names are those generally attributed to antimicrobials which are used in food-producing animals, i.e. development of antimicrobial resistance in target bacteria, dissemination of resistant bacteria/resistance factors etc.
Tveganja, povezana z uporabo zdravila Lincocin in z njimi povezanih imen, so enaka kot pri običajnih protimikrobnih zdravilih, ki se uporabljajo pri živalih za prehrano ljudi, tj. razvoj protimikrobne odpornosti pri ciljnih bakterijskih vrstah, razširjanje odpornih bakterij/dejavnikov odpornosti itd.
People with known hypersensitivity to lincomycin or any other lincosamide, or to lactose monohydrate, should avoid contact with the veterinary medicinal product.
Ljudje, pri katerih je znana preobčutljivost na linkomicin ali ostale linkozamide ali na laktozo monohidrat, se morajo izogibati stiku s tem zdravilom.
Wash hands and any exposed skin with soap and water immediately after use.
Takoj po uporabi si umijte roke in izpostavljeno kožo z milom in vodo.
Given the results from the provided residue depletion study and the calculations made by the CVMP, a withdrawal period of 1 day was recommended.
Glede na rezultate predložene študije o izločanju ostankov in izračune odbora CVMP je bila priporočena karenca en dan.
This product contains lincomycin and lactose monohydrate, either of which can cause allergic reactions in some people.
To zdravilo vsebuje linkomicin in laktozo monohidrat, ki lahko pri ljudeh povzročata alergične reakcije.
It should be noted that no standardised procedures for MIC testing of antimicrobial agents against mycoplasmas and no clinical breakpoints exist, which has made the comparison of results of different studies difficult.
Opozoriti je treba, da ni standardiziranih postopkov za določanje vrednosti MIK protimikrobnih zdravil proti mikoplazmam niti kliničnih mejnih vrednosti, kar je otežilo primerjavo rezultatov različnih študij.
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 causing premature peptidyl-tRNA dissociation from the ribosome.
Linkomicin se veže na podenoto bakterijskega ribosoma 50 S, ki je blizu centra za prenos peptidov, in moti proces elongacije peptidne verige, tako da povzroči prezgodnjo disociacijo peptidil-tRNA iz ribosomov.
The bioavailability of lincomycin may decrease in the presence of gastric antacids or activated charcoal, pectin or kaolin.
Biološka razpoložljivost linkomicina se lahko zmanjša v prisotnosti želodčne kisline ali aktivnega oglja, pektina ali kaolina.
Shelf life after first opening the container: use immediately.
Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
Lincomycin can potentiate neuromuscular effects of anaesthetics and muscle relaxants.
Linkomicin lahko potencira nevromuskularne učinke anestetikov in mišičnih relaksansov.
Based on the results from the study and the calculations made by the CVMP, it was concluded that a zero-day withdrawal period for pig meat and offal may not be safe for the consumers as the first time point at which all samples were below their respective maximum residue limits (MRLs) was 12
Na podlagi rezultatov študije in izračunov odbora CVMP je bilo sklenjeno, da obdobje karence nič dni za prašičje meso in drobovino morda ni varno za potrošnike, saj je bila koncentracija zdravila v vseh vzorcih pod najvišjo mejno vrednostjo ostankov (MRL, maximum residue limits) po 12 urah.
Having considered the grounds for referral and the data provided by the marketing authorisation holder, the CVMP concluded that the benefit-risk balance of the product remains positive for use in pigs and chickens subject to the recommended changes in the product information.
Po proučitvi razlogov za napotitev in podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, je odbor CVMP ugotovil, da je razmerje med koristmi in tveganjem zdravila še naprej pozitivno za uporabo pri prašičih in piščancih, če se upoštevajo priporočene spremembe informacij o zdravilu.
Chickens were administered lincomycin hydrochloride in the drinking water at a level of approximately 34 mg/litre (5.1-6.6 mg/kg body weight) for seven days.
Piščancem so dajali linkomicinijev klorid v pitni vodi na ravni približno 34 mg / 1L (5,1-6,6 mg / kg telesne mase) sedem dni.
Although the studies were conducted in the USA in the 1980s and MICs of the isolates responsible for necrotic enteritis in two of the studies are not known, the marketing authorisation holder has determined the MICs of C. perfringens isolates obtained from chickens in the USA in the 1990s.
Čeprav sta bili študiji izvedeni v ZDA v 1980-ih in vrednosti MIK pri izolatih, ki so v študijah povzročili nekrotični enteritis, niso znane, je imetnik dovoljenja za promet določil vrednosti MIK pri izolatih C. perfringens, osamljenih iz piščancev v ZDA v 1990-ih.
Do not mix with any other veterinary medicinal product
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
An up-to-date residue depletion study was provided with a soluble powder containing a combination of lincomycin and spectinomycin, and the dose of lincomycin that was administered was approximately 3 to 5 times higher than the recommended dose for Lincocin.
Najnovejša študija izločanja ostankov je bila opravljena s topnim praškom, ki je vseboval kombinacijo linkomicina in spektinomicina, uporabljeni odmerek linkomicina pa je bil približno 3 do 5-krat večji od priporočenega odmerka za zdravilo Lincocin.
Based on the documentation provided, the proposed withdrawal period of 5 days for chicken meat and offal was considered to be safe for the consumers.
Na podlagi predložene dokumentacije se je predlagana karenca pet dni za piščančje meso in drobovino štela za varno za potrošnike.
In addition, in a recent referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs or chickens (EMEA/V/A/110)1, the CVMP concluded that indications relating to swine dysentery caused by B. hyodysenteriae were not sufficiently supported and should be deleted from the product information.
Poleg tega je odbor CVMP v nedavnem napotitvenem postopku v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kombinacijo linkomicina in spektinomicina, ki se dajejo peroralno prašičem ali piščancem (EMEA/V/A/110)1, zaključil, da indikacije v zvezi s prašičjo dizenterijo, ki jo povzroča B. hyodysenteriae, niso bile zadostno podprte in jih je treba črtati iz informacij o zdravilu.
Approximately 50% of lincomycin is metabolised in the liver.
Približno 50% linkomicina se presnavlja v jetrih.
Satisfactory withdrawal periods have been set to provide assurance of consumer safety.
Določene so bile zadovoljive karence, ki zagotavljajo varnost potrošnikov.
However, given the variability in active substance intake that can result from dosing via drinking water and the good safety profile for lincomycin, a dose greater than the minimum effective dose was considered to be justifiable.
Če se upošteva spremenljivost vnosa zdravilne učinkovine, ki je posledica odmerjanja v pitno vodo, in dober varnostni profil linkomicina, odmerek, ki je večji od najmanjšega učinkovitega odmerka, velja za upravičenega.
A withdrawal period of 1 day was therefore recommended for pig meat and offal as this gives a sufficient margin of safety.
Za prašičje meso in drobovino je priporočljiva karenca 1 dan, saj zagotavlja zadostno raven varnosti.
The clinical data provided indicated that Lincocin was effective for the treatment of swine dysentery caused by B. hyodysenteriae; however, the studies in question were conducted in the period 1977-1993 and the MICs of isolates were not determined in the majority of clinical studies submitted.
Predloženi klinični podatki so pokazali, da je zdravilo Lincocin učinkovito za zdravljenje prašičje dizenterije, ki jo povzroča B. hyodysenteriae, vendar so bile zadevne študije izvedene v obdobju 1977-1993 in v večini predloženih kliničnih študij vrednosti MIK pri izolatih niso bile določene.
For this reason the above study could be accepted for the determination of the chicken meat and offal withdrawal period for Lincocin.
Zaradi navedenega bi lahko študijo sprejeli za določitev obdobja karence za piščančje meso in drobovino za zdravilo Lincocin.
However, the most prevalent mechanism in mycoplasmas is the alteration of the binding site through mutational events (chromosomal resistance).
Vendar je najpogostnejši mehanizem v mikoplazmah sprememba mesta vezave z mutacijskimi dogodki (kromosomska odpornost).
Overall, considering the scope of procedure the CVMP was of the opinion that the indication ‘Treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae' was adequately justified.
Na splošno je odbor CVMP v okviru postopka menil, da je bila indikacija „Zdravljenje in metafilaksa enzootske pljučnice, ki jo povzroča Mycoplasma hyopneumoniae“, zadostno utemeljena.
In case of accidental overdose, the treatment must be stopped and restarted at the recommended dose level.
V primeru nenamernega prevelikega odmerjanja, prenehajte z zdravljenjem in ponovno začnite s priporočenim odmerkom.
The following indications for Lincocin and its associated names can be supported based on the data provided:
Na podlagi predloženih podatkov je mogoče podpreti naslednje indikacije za zdravilo Lincocin in z njim povezana imena:
Do not use in cases of known resistance to lincosamides.
Ne uporabite v primeru rezistence na linkozamide.
Additionally, the CVMP considered that the following warning needed to be added to section 4.4 ‘Special warnings for each target species' of the summary of product characteristics (SPC):
Poleg tega je odbor CVMP menil, da je treba v poglavje 4.4 „Posebna opozorila za vsako ciljno živalsko vrsto“ v povzetku glavnih značilnosti zdravila dodati naslednje opozorilo:
It might be the case that local intestinal concentrations of lincomycin exceed the MIC of non-wild-type isolates.
Morda je to posledica višjih lokalnih koncentracij linkomicina v črevesju, ki presegajo vrednosti MIK pri izolatih, ki niso divji tipi.
It seemed to be in line with the posology assessed in the studies provided; however, the two-fold dose range with no clear guidance for the end-user as to when to administer the product at either the higher or lower limit of the range was considered to be ambiguous.
Zdi se, da je to v skladu z odmerjanjem v predloženih študijah, vendar je največji odobreni odmerek dvakratnik najmanjšega, hkrati pa ni jasnih smernic za končnega uporabnika glede izbire večjega oz. manjšega odmerka, kar se šteje za nejasno.
This exceeded the minimum effective dose rate (3.9 mg/kg) established in the dose evaluation study and was within the range tested in the dose confirmation and target animal safety studies.
učinkoviti odmerek (3,9 mg/kg), ki je bil določen v študiji vrednotenja odmerka, vendar je znotraj območja preskušenih odmerkov v študijah potrditve odmerjanja in študijah o varnosti pri ciljnih živalskih vrstah.
In conclusion, considering that the susceptibility pattern of C. perfringens to lincomycin has not changed significantly over the last 25 years and the lack of a definite correlation between MICs and clinical efficacy and in the context of the procedure, the CVMP considered that the indication is adequately justified and hence chickens can be retained as a target species.
Odbor CVMP je ob upoštevanju, da se vzorec občutljivosti C. perfringens za linkomicin v zadnjih 25 letih ni bistveno spremenil, odsotnosti prepričljive korelacije med vrednostmi MIK in klinično učinkovitostjo ter konteksta postopka, menil, da je indikacija zadostno utemeljena, zato se piščanci lahko ohranijo kot ciljna živalska vrsta.
One composite muscle sample out of three had residues slightly above the MRL (57 µg/kg versus 50 µg/kg).
En sestavljen vzorec mišic od treh je imel koncentracijo ostankov nekoliko nad najvišjo mejno vrednostjo (57 μg/kg glede na mejno vrednost 50 μg/kg).
The CVMP noted that a residue depletion study using Lincocin itself (or a bioequivalent product) would have been preferable.
Odbor CVMP je ugotovil, da bi bila bolj primerna študija izločanja ostankov, v kateri bi uporabili samo zdravilo Lincocin (ali biološko enakovredno zdravilo).
However, as the pharmacokinetic parameters were greater upon administration of the soluble powder, and it is generally recognised that soluble powders are likely to result in a better bioavailability of the active substance in comparison to in-feed formulations, the CVMP accepted that clinical results relating to the premix formulation could be extrapolated to the soluble powder.
Ker so bili farmakokinetični parametri večji pri dajanju topnega praška in ker na splošno velja, da imajo topni praški verjetno večjo biološko uporabnost zdravilne učinkovine v primerjavi s formulacijami v krmi, je odbor CVMP sklenil, da se lahko klinične rezultate, ki se nanašajo na formulacijo predmešanice, ekstrapolira na topni prašek.
Antagonism may exist between lincomycin and macrolides such as erythromycin and other bactericidal antibiotics; concurrent use is therefore not recommended due to competitive binding at the 50S ribosomal subunit of the bacterial cell.
Med linkomicinom in makrolidi kot je eritromicin ali drugimi baktericidnimi antibiotiki lahko pride do antagonizma, zato hkratna uporaba ni priporočljiva zaradi kompetitivne vezave na 50S ribosomalno podenoto bakterijske celice.
Unmetabolised lincomycin declined at a slightly faster half-life (t½ = 5.8 hours) than total residue.
Ne metaboliziran linkomicin se je zmanjšal pri nekoliko večji razpolovni dobi (t½ = 5,8 ure) kot skupni ostanek.
Pigs: Meat and offal: 1 day.
Prašiči: meso in organi: 1 dan.
Some of the studies in which lincomycin was administered in feed were considered to demonstrate a therapeutic and/or metaphylactic effect of lincomycin against enzootic pneumonia.
Nekatere študije, v katerih so dajali linkomicin v krmi, so se štele za dokaz terapevtskega in/ali metafilaktičnega učinka linkomicina proti enzootski pljučnici.
Mean body weight (kg) of animals to be treated
Povprečna telesna masa ( v kg) zdravljenih živali
With regard to the clinical data, several of the studies submitted by the marketing authorisation holder were conducted with an in-feed formulation of lincomycin.
Klinični podatki v več študijah, ki jih je predložil imetnik dovoljenja za promet z zdravilom, so bili zbrani s formulacijo linkomicina v krmi.
Although these risks have 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 group is a reality.
Čeprav ta tveganja niso bila nedvoumno ovrednotena, obstaja realna možnost vpliva na zdravje ljudi zaradi navzkrižne odpornosti proti klindamicinu in drugim snovem iz skupine makrolidov, linkozamidov in streptograminov.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Navodila za odmerjanje in priporočeni odmerki: Da bi zagotovili pravilen odmerek, je treba telesno težo določiti čim bolj natančno, da se izognemo nezadostnemu odmerjanju.
Lincomycin undergoes enterohepatic circulation.
Linkomicin gre skozi enterohepatično cirkulacijo.
Therefore, it was considered that the proposed withdrawal period of 5 days can be regarded as safe for the recommended dosing regimen of 5 mg of lincomycin per kg of body weight per day for 7 days.
Zato je bilo ocenjeno, da se predlagana karenca pet dni lahko šteje za varno pri priporočeni shemi odmerjanja 5 mg linkomicina na kilogram telesne mase na dan 7 dni zapored.
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 target animal safety and user safety did not present new issues.
Ker odbor CVMP ni priporočil povečanja sheme odmerjanja in razširitve indikacij glede na večino odobrenih povzetkov glavnih značilnosti zdravila, se pri ocenjevanju varnosti pri ciljnih živalskih vrstah in varnosti uporabnikov niso pojavila nova vprašanja.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
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 izpostavitvi pojavijo simptomi, kot so kožni izpuščaj ali vztrajno draženje oči, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali etiketo.
The dosage used (approximately 10 mg lincomycin/kg body weight/day administered in drinking water) was considered to be representative of the maximum amount of lincomycin recommended for the product.
Uporabljeni odmerek (približno 10 mg linkomicina/kg telesne mase/dan, dajanje s pitno vodo) je bil reprezentativen za največjo količino linkomicina, priporočenega za zdravilo.
The benefit-risk balance in relation to the use of Lincocin against swine dysentery caused by B. hyodysenteriae is considered to be negative due to development of acquired resistance and high uncertainty about its impact in terms of in vivo efficacy.
Razmerje med koristmi in tveganjem v zvezi z uporabo zdravila Lincocin proti prašičji dizenteriji, ki jo povzroča B. hyodysenteriae, je negativno zaradi razvoja pridobljene odpornosti in velike negotovosti glede njenega vpliva na učinkovitost zdravila in vivo.
Incompatibilities: Do not mix with any other veterinary medicinal product.
Glavne inkompatibilnosti Ne mešajte z nobenim drugim zdravilomza uporabo v veterinarski medicini.
Additionally the wording of section 4.9 ‘Amounts to be administered and route of administration' of the SPC was extensively modified, with the main aim of increasing clarity.
Poleg tega je bilo besedilo poglavja 4.9 „Odmerjanje in pot uporabe“ v povzetku glavnih značilnosti zdravila obširno spremenjeno z glavnim ciljem povečanja jasnosti.
Lincomycin resistance mediated by efflux pumps, or by inactivating enzymes, has also been described.
Opisana je bila tudi odpornost na linkomicin s posredovanjem iztočne črpalke ali z inaktiviranjem encimov.
It is bacteriostatic and primarily active against Gram-positive bacteria (both aerobic and anaerobic), Gram-negative anaerobic bacteria and mycoplasma.
Je bakteriostatičen in v prvi vrsti deluje proti grampozitivnim bakterijam (aerobnim in anaerobnim), gramnegativnim anaerobnim bakterijam in mikoplazmam.
Section 4.9 ‘Amounts to be administered and route of administration' of the SPC was nevertheless modified, mainly for the purpose of increased clarity.
Poglavje 4.9 „Odmerjanje in pot uporabe“ v povzetku glavnih značilnosti zdravila je bilo kljub temu spremenjeno, predvsem zaradi večje jasnosti.
The marketing authorisation holder also provided additional data from one study which investigated the efficacy of lincomycin as the soluble powder, administered in drinking water to pigs on a farm with known problems with enzootic pneumonia.
Imetnik dovoljenja za promet z zdravilom je predložil tudi dodatne podatke iz študije, v kateri so raziskali učinkovitost linkomicina v obliki topnega praška, ki se daje v pitno vodo, za prašiče na kmetiji s težavami z enzootsko pljučnico v preteklosti.
The dosing regimen for the indication was not changed and remained at 10 mg lincomycin/kg body weight daily for 21 consecutive days.
Režim odmerjanja za indikacijo se ni spremenil in je ostal 10 mg linkomicina/kg telesne mase na dan 21 dni zapored.
MANUFACTURER'S BATCH NUMBER Lot {number}:
IZDELOVALČEVA ŠTEVILKA SERIJE
Macrolides, lincosamides and streptogramins antimicrobials are listed by WHO (2017)3 as critically important for the treatment of certain zoonotic infections in humans (such as Campylobacter infections).
Svetovna zdravstvena organizacija (2017)3 navaja, da so makrolidi, linkozamidi in streptogramini, protimikrobna zdravila ključnega pomena za zdravljenje določenih zoonotskih okužb pri ljudeh (kot je kampilobakterioza).
A dose titration study investigated the therapeutic effect of various levels of lincomycin administered via drinking water on necrotic enteritis in broilers under simulated natural conditions.
V študiji titracije odmerka so raziskali terapevtski učinek različnih ravni linkomicina, ki so ga dajali s pitno vodo, na nekrotični enteritis pri pitovnih piščancih v simuliranih naravnih pogojih.
There is often complete cross-resistance between lincomycin and clindamycin.
Pogosta je popolna navzkrižna odpornost med linkomicinom in klindamicinom.