FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: One composite muscle sample out of three had residues slightly above the MRL (57 µg/kg versus 50 µg/kg).
Slovenian: 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).
English: The CVMP noted that a residue depletion study using Lincocin itself (or a bioequivalent product) would have been preferable.
Slovenian: Odbor CVMP je ugotovil, da bi bila bolj primerna študija izločanja ostankov, v kateri bi uporabili samo zdravilo Lincocin (ali biološko enakovredno zdravilo).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Unmetabolised lincomycin declined at a slightly faster half-life (t½ = 5.8 hours) than total residue.
Slovenian: Ne metaboliziran linkomicin se je zmanjšal pri nekoliko večji razpolovni dobi (t½ = 5,8 ure) kot skupni ostanek.
English: Pigs: Meat and offal: 1 day.
Slovenian: Prašiči: meso in organi: 1 dan.
English: 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.
Slovenian: Nekatere študije, v katerih so dajali linkomicin v krmi, so se štele za dokaz terapevtskega in/ali metafilaktičnega učinka linkomicina proti enzootski pljučnici.
English: Mean body weight (kg) of animals to be treated
Slovenian: Povprečna telesna masa ( v kg) zdravljenih živali
English: 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.
Slovenian: Klinični podatki v več študijah, ki jih je predložil imetnik dovoljenja za promet z zdravilom, so bili zbrani s formulacijo linkomicina v krmi.
English: 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.
Slovenian: 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.
English: To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Slovenian: Navodila za odmerjanje in priporočeni odmerki: Da bi zagotovili pravilen odmerek, je treba telesno težo določiti čim bolj natančno, da se izognemo nezadostnemu odmerjanju.
English: Lincomycin undergoes enterohepatic circulation.
Slovenian: Linkomicin gre skozi enterohepatično cirkulacijo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
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.
Slovenian: 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.
English: 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.
Slovenian: Uporabljeni odmerek (približno 10 mg linkomicina/kg telesne mase/dan, dajanje s pitno vodo) je bil reprezentativen za največjo količino linkomicina, priporočenega za zdravilo.
English: 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.
Slovenian: 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.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Slovenian: Glavne inkompatibilnosti Ne mešajte z nobenim drugim zdravilomza uporabo v veterinarski medicini.
English: 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.
Slovenian: Poleg tega je bilo besedilo poglavja 4.9 „Odmerjanje in pot uporabe“ v povzetku glavnih značilnosti zdravila obširno spremenjeno z glavnim ciljem povečanja jasnosti.
English: Lincomycin resistance mediated by efflux pumps, or by inactivating enzymes, has also been described.
Slovenian: Opisana je bila tudi odpornost na linkomicin s posredovanjem iztočne črpalke ali z inaktiviranjem encimov.
English: It is bacteriostatic and primarily active against Gram-positive bacteria (both aerobic and anaerobic), Gram-negative anaerobic bacteria and mycoplasma.
Slovenian: Je bakteriostatičen in v prvi vrsti deluje proti grampozitivnim bakterijam (aerobnim in anaerobnim), gramnegativnim anaerobnim bakterijam in mikoplazmam.
English: Section 4.9 ‘Amounts to be administered and route of administration' of the SPC was nevertheless modified, mainly for the purpose of increased clarity.
Slovenian: Poglavje 4.9 „Odmerjanje in pot uporabe“ v povzetku glavnih značilnosti zdravila je bilo kljub temu spremenjeno, predvsem zaradi večje jasnosti.
English: 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.
Slovenian: 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.
English: The dosing regimen for the indication was not changed and remained at 10 mg lincomycin/kg body weight daily for 21 consecutive days.
Slovenian: Režim odmerjanja za indikacijo se ni spremenil in je ostal 10 mg linkomicina/kg telesne mase na dan 21 dni zapored.
English: MANUFACTURER'S BATCH NUMBER Lot {number}:
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: There is often complete cross-resistance between lincomycin and clindamycin.
Slovenian: Pogosta je popolna navzkrižna odpornost med linkomicinom in klindamicinom.
English: With regard to the in vitro susceptibility data, although there is no standardised methodology for determination of the MIC for antibiotics against B. hyodysenteriae, it was evident that the majority of isolates fall outside the apparent wild-type population.
Slovenian: Podatki o občutljivosti in vitro kažejo, da čeprav ni standardizirane metodologije za določanje vrednosti MIK antibiotikov proti B. hyodysenteriae, večina izolatov ne sodi v populacijo sevov divjega tipa.
English: Despite the lack of standardised procedures for MIC testing of antimicrobial agents against mycoplasmas and clinical breakpoints, based on the MIC data provided it could be concluded that the susceptibility pattern of M. hyopneumoniae to lincomycin has not changed significantly over the last 20-25 years.
Slovenian: Kljub pomanjkanju standardiziranih postopkov za določanje MIK protimikrobnih zdravil proti mikoplazmam in kliničnih mejnih vrednosti, ki temeljijo na podatkih MIK, je mogoče sklepati, da se vzorec občutljivosti M. hyopneumoniae za linkomicin v zadnjih 20-25 letih ni bistveno spremenil.
English: Nevertheless, based on the MIC data provided including the study conducted by the marketing authorisation holder in 2016, it could be concluded that the susceptibility pattern of M. hyopneumoniae to lincomycin has not changed significantly over the last 20-25 years.
Slovenian: Kljub temu je bilo možno na podlagi predloženih podatkov o vrednostih MIK in študije, ki jo je imetnik dovoljenja za promet opravil leta 2016, zaključiti, da se vzorec občutljivosti M. hyopneumoniae za linkomicin v zadnjih 20-25 letih ni bistveno spremenil.
English: Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na učinkovino, na dodatek ali na katero koli pomožno snov.
English: preferable; based on the data available and taking into account the variability of water intake and hence the dose ingested by the treated animals, a dose rate of 5 mg lincomycin per kg of body weight for 7 days was proposed.
Slovenian: Prednost ima ena (optimalna) velikost odmerka; na podlagi razpoložljivih podatkov in ob upoštevanju spremenljivosti vnosa vode in posledično odmerka, ki ga zaužijejo zdravljene živali, je bil predlagan odmerek 5 mg linkomicina na kg telesne mase 7 dni zapored.
English: Dosage (mg product per kg body weight per day)
Slovenian: Odmerek (mg zdravila na kg telesne mase na dan)
English: In addition, there is a lack of clinical breakpoints for both M. hyopneumoniae and C. perfringens.
Slovenian: Poleg tega ni kliničnih mejnih vrednosti za M. hyopneumoniae in C. perfringens.
English: Where possible, therapy should be based on local (regional, farm level) epidemiological information concerning the response of enzootic pneumonia/necrotic enteritis to treatment with lincomycin.”
Slovenian: Če je mogoče, mora zdravljenje temeljiti na lokalnih (regionalnih, na ravni kmetije) epidemioloških informacijah glede odziva enzootske pljučnice/nekrotičnega enteritisa na zdravljenje s linkomicinom.“
English: White high density polyethylene (HDPE) bottle containing 150 g or 1.5 kg powder for use in drinking water with a tamper evident low density polyethylene (LDPE) lid.
Slovenian: Bela plastenka iz polietilena visoke gostote (HDPE), ki vsebuje 150 g ali 1,5 kg praška za uporabo v pitni vodi s pokrovčkom iz polietilena nizke gostote (LDPE).
English: Repeated dosing of pigs with daily oral doses of 22 mg lincomycin/kg body weight for 3 days indicated no accumulation of lincomycin in the species, with no detectable serum levels of antibiotic after 24 hours post administration.
Slovenian: Ponavljajoče se odmerjanje prašičem, z dnevnimi peroralnimi odmerki 22 mg linkomicina / kg telesne mase za 3 dni ni nakazovalo kopičenja lincomicina pri tej živalski vrsti, pri čemer se po 24 urah po dajanju ne zaznavajo serumske vrednosti antibiotika.
English: For chickens, the currently authorised dose and the harmonised proposal was to administer 3-6 mg lincomycin per kg of body weight daily for 7 consecutive days.
Slovenian: Za piščance je trenutno odobreni odmerek in usklajeni predlog odmerka 3-6 mg linkomicina na kg telesne mase na dan 7 dni zapored.
English: Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Slovenian: Linkomicin je antibiotik iz skupine linkozamidov in je proizvod bakterije Streptomyces lincolensis, ki inhibira sintezo beljakovin.
English: Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to the lincomycin and may decrease the effectiveness of treatment with other lincosamides, macrolides and streptogramin B due to the potential for cross-resistance.
Slovenian: Uporaba zdravila za uporabo v veterinarski medicini, ki odstopa od navodil, navedenih v povzetku glavnih značilnosti zdravila, lahko poveča razširjenost bakterij, odpornih na linkomicin, in lahko zmanjša učinkovitost zdravljenja z drugimi linkozamidi, makrolidi in streptogramini B zaradi možnosti navzkrižne odpornosti.
English: A dosage greater than 10 mg lincomycin per kg of body weight may cause diarrhoea and loose stools in pigs.
Slovenian: Večji odmerki od 10 mg linkomicina/kg telesne mase lahko povzročijo drisko in mehko blato pri prašičih.
English: 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.
Slovenian: Enkratna peroralna administracija linkomicinijevega klorida pri odmerkih približno 22, 55 in 100 mg / kg telesne mase pri prašičih omogoča vsebnost serumskega odmerka linkomicina, ugotovljeno 24 do 36 ur po dajanju.
English: Pigs, poultry (broilers)
Slovenian: Prašiči Perutnina (brojlerji)
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE
English: • Indications
Slovenian: • indikacije,
English: Lincomycin is active against some gram-positive bacteria (Clostridium perfringens) and mycoplasmas (Mycoplasma hyopneumoniae).
Slovenian: Lincomycin deluje proti nekaterim gram- pozitivnim bakterijam (Clostridium perfringens) in mikoplazmam (Mycoplasma hyopneumoniae).
English: Regarding the determination of the withdrawal period, no residue depletion studies have been conducted with Lincocin in chickens using a modern (HPLC) assay method.
Slovenian: Kar zadeva določitev karence, študije o izločanju ostankov linkomicina niso bile opravljene s sodobno analizno metodo (HPLC).
English: Pharmacotherapeutic group: Antibacterials for systemic use; Lincosamides.
Slovenian: Farmakoterapevtska skupina: Protimikrobne učinkovine za sistemsko zdravljenje, Linkozamidi
English: Meat and offal: 5 days.
Slovenian: Meso in organi : 5 dni.
English: • the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
Slovenian: • namen napotitve je bila uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
English: The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay in the target species.
Slovenian: Varnost zdravila v obdobju brejosti, laktacije ali nesnosti ni bila ugotovljena.
English: Based on the observed depletion pattern, a 5-day withdrawal period was shown to be appropriate for the combination product.
Slovenian: Na podlagi ugotovljenega vzorca izločanja je bilo dokazano, da je za kombinirano zdravilo primerna petdnevna karenca.
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1
Slovenian: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-laNeuve
English: The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints.
Slovenian: Občutljivost Mycoplasma hyopneumoniae na protimikrobno učinkovino je težko preskušati in vitro zaradi tehničnih omejitev.
English: Resistance to lincomycin is frequently conferred by plasmid-borne factors (erm genes) coding for methylases modifying the ribosomal binding site and frequently leading to cross-resistance to other antimicrobials of the macrolides, linconsamides and streptogramins group.
Slovenian: Odpornost na linkomicin pogosto povzročajo prenosljivi plazmidi (geni), ki kodirajo metilaze, ki spreminjajo mesto vezave ribosomov in pogosto vodijo do navzkrižne odpornosti proti drugim protimikrobnim zdravilom iz skupin makrolidov, linkozamidov in streptograminov.
English: The active substance lincomycin is a lincosamide antibiotic and is produced by Streptomyces lincolnensis.
Slovenian: Zdravilna učinkovina linkomicin je linkozamidni antibiotik, ki ga tvori Streptomyces lincolnensis.
English: CVMP opinion for a referral procedure (EMEA/V/A/110) under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry - link procedure, the CVMP concluded that this indication should also be deleted from the product information for Lincocin.
Slovenian: 1 CVMP opinion for a referral procedure (EMEA/V/A/110) under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry - link
English: Do not administer, and do not allow access to water containing lincomycin, to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result in severe gastro-intestinal disturbance.
Slovenian: Zdravila ne dajemo in ne dovolimo dostopa do pitne vode, ki vsebuje linkomicin kuncem, hrčkom, morskim prašičkom, činčilam, konjem ali prežvekovalcem, saj to lahko vodi v resnejše gastrointestinalne motnje.
English: Bottle of 150 g Bottle of 1.5 kg
Slovenian: Plastenka s 150 g ali 1,5 kg
English: Regarding laying hens, there are no data to support a withdrawal period in eggs; hence, the use of the product should not be authorised in laying birds producing eggs for human consumption.
Slovenian: Kar zadeva kokoši nesnice, ni podatkov, ki bi podprli karenco za jajca; zato se pri nesnicah, ki ležejo jajca za prehrano ljudi, ne sme dovoliti uporabe zdravila.
English: Lincocin is a powder for oral solution containing 400 mg lincomycin per gram product.
Slovenian: Zdravilo Lincocin je prašek za peroralno raztopino, ki vsebuje 400 mg linkomicina na gram zdravila.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
English: = ___ mg product per litre drinking water
Slovenian: = ___ mg zdravila na liter pitne vode
English: Medicated drinking water uptake can be affected by the severity of the disease.
Slovenian: Resnost bolezni lahko vpliva na vnos pitne vode.
English: Crossing the intestinal barrier, lincomycin is widely distributed to all tissues, especially the lungs and joint cavities; the volume of distribution is about 1 litre.
Slovenian: Pri prehajanju preko črevesne pregrade se linkomicin široko porazdeli v vsa tkiva, zlasti pljuča in sklepne votline; volumen porazdelitve je približno 1 L. Razpolovni čas izločanja linkomicina je večji od 3 ur.
English: Therefore, the high in vitro resistance level in B. hyodysenteriae constitutes a major uncertainty as to the clinical effectiveness of Lincocin.
Slovenian: Posledično veliko negotovost o klinični učinkovitosti zdravila Lincocin predstavlja visoka stopnja odpornosti in vitro pri B. hyodysenteriae.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Slovenian: Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
English: As there were no data to support a withdrawal period in laying hens, the use of the product should not be authorised in laying birds producing eggs for human consumption.
Slovenian: Ker ni bilo podatkov, ki bi podprli karenco pri kokoših nesnicah, se zdravilo ne sme odobriti za uporabo pri nesnicah, ki ležejo jajca za prehrano ljudi.
English: Special warnings for each target species:
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto
English: The CVMP acknowledged the difficulties in determining a single dose and agreed that although somewhat arbitrarily selected, the proposal for a dose rate of 5 mg lincomycin per kg of body weight for 7 days is acceptable.
Slovenian: Odbor CVMP je seznanjen s težavami pri določanju enega samega odmerka in se strinja, da je sprejemljiv predlog odmerka 5 mg linkomicina na kg telesne mase 7 dni zapored, čeprav je številka izbrana nekoliko arbitrarno.
English: Colloidal anhydrous silica Lactose monohydrate
Slovenian: Laktoza monohidrat
English: The in vitro data from published literature and from the marketing authorisation holder's own study indicated that the MICs for lincomycin had wide ranges and were not unimodal.
Slovenian: Podatki in vitro iz objavljene literature in iz lastne študije imetnika dovoljenja za promet so pokazali, da so vrednosti MIK linkomicina imele širok razpon in niso bile porazdeljene unimodalno.