FrancophonIA/ELRC3.0 huggingface dataset:
English: • The inclusion of information about resistance status and warnings about prudent use as regards resistance, in SPC sections 4.4 ‘Special warnings for each target species', 4.5 (i) ‘Special precautions for use in animals' and 5.1 ‘Pharmacodynamic properties'.
Slovenian: • vključitvijo informacij o stanju odpornosti in opozoril o preudarni rabi v zvezi z odpornostjo v poglavja 4.4 „Posebna opozorila za vsako ciljno živalsko vrsto“, 4.5 (i) „Posebni previdnostni ukrepi za uporabo pri živalih“ in 5.1 „Farmakodinamične lastnosti“ v povzetku glavnih značilnosti zdravila.
English: The slaughter times (0 hours after 3 days of medication and 0, 6, 12 and 24 hours after 21 days of medication) were well distributed to support the proposed zero-day withdrawal period.
Slovenian: Časi zakola (0 ur po 3 dneh zdravljenja in 0, 6, 12 in 24 ur po 21 dneh zdravljenja) so bili dobro razporejeni, da bi podprli predlagano karenco nič dni.
English: Risks for users were considered low and adequate information is included in the product information to ensure the safety for the user.
Slovenian: Tveganje za uporabnike je bilo ocenjeno kot nizko, informacije o zdravilu pa vsebujejo ustrezne informacije za zagotavljanje varnosti uporabnikov.
English: At 2 days after the end of treatment, residues in liver, kidney and muscle were all below the MRLs.
Slovenian: Po 2 dneh po koncu zdravljenja so bili vsi ostanki v jetrih, ledvicah in mišicah pod ravnijo MRL.
English: After the end of the medication period, the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Slovenian: Po končanem zdravljenju je treba vodovodni sistem ustrezno očistiti, da se prepreči vnos subterapevtskih količin zdravilne učinkovine.
English: The excreta contained mostly unmetabolised lincomycin (60-85%) during treatment.
Slovenian: Med zdravljenjem so izločki vsebovali večinoma ne-metaboliziran linkomicin (60-85%).
English: On 5 July 2016 the European Commission sent a referral notification under Article 34 of Directive 2001/82/EC to the European Medicines Agency for Lincocin and its associated names.
Slovenian: Evropska komisija je 5. julija 2016 Evropsko agencijo za zdravila obvestila o napotitvi na podlagi člena 34 Direktive 2001/82/ES za zdravilo Lincocin in povezana imena.
English: Allergic/hypersensitive reactions occur on rare occasions.
Slovenian: Alergične/preobčutljivostne reakcije so redke.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: Lincomycin and one unknown metabolite comprised >50% of the muscle residue at zero hours.
Slovenian: Linkomicin in en neznan metabolit sta predstavljala > 50% mišičnega ostanka v ničelnih urah.
English: It was calculated that a concentration of 16.9 mg/l was the minimal dose that would give the maximum effect; this corresponds with a calculated dose of 3.9 mg/kg body weight.
Slovenian: Izračunali so, da je koncentracija 16,9 mg/l minimalni odmerek, ki bi imel največji učinek; to ustreza izračunanemu odmerku 3,9 mg/kg telesne mase.
English: The harmonised warnings and precautions proposed in the product information were considered adequate to ensure safety to users of the product.
Slovenian: Usklajena opozorila in previdnostni ukrepi, predlagani v informacijah o zdravilu, so se šteli za primerne za zagotovitev varnosti uporabnikov zdravila.
English: Do not use in cases of hepatic dysfunction.
Slovenian: Ne uporabite v primeru jetrne disfunkcije.
English: For example, the results of the study conducted by the marketing authorisation holder in 2016 with 92 European isolates showed a MIC range of 0.5 μg/ml to >256 μg/ml and a tri-modal MIC distribution for lincomycin against C. perfringens (peaks at 1 μg/ml, 8 μg/ml and >256 μg/ml), with the majority of isolates falling outside the apparent wild-type population.
Slovenian: Na primer, rezultati študije, ki jo je leta 2016 opravil imetnik dovoljenja za promet na 92 evropskih izolatih, kažejo razpon vrednosti MIK od 0,5 μg/ml do > 256 μg/ml in trimodalno porazdelitev vrednosti MIK linkomicina proti C. perfringens (vrhovi pri 1 μg/ml, 8 μg/ml in > 256 μg/ml), pri čemer večina izolatov ne spada v navidezno populacijo sevov divjega tipa.
English: 02-676 Warsaw
Slovenian: Postępu 17B 02-676 Warsaw Poland
English: The minimum effective dose would appear to be approximately 4 mg/kg per kg of body weight and selection of this dose would result in a maximal therapeutic index.
Slovenian: Kaže, da je najmanjši učinkovit odmerek približno 4 mg/kg na kg telesne mase in izbira tega odmerka bi privedla do največjega terapevtskega indeksa.
English: Laboratory studies in rats have not produced any evidence of teratogenic effects, although foetotoxicity has been reported.
Slovenian: Z laboratorijskimi študijami na podganah niso bili dokazani teratogeni učinki, čeprav so poročali o fetotoksičnosti.
English: Indeed, there was evidence, albeit from a subclinical infection model, that MIC values above those for the apparent wild-type population do not necessarily correlate to a lack of clinical effectiveness of lincomycin (Lanckriet et al., 2010)2.
Slovenian: Prav nasprotno, obstajajo dokazi, čeprav iz modela subklinične okužbe, da vrednosti MIK, ki so višje od koncentracij za navidezno populacijo divjega tipa, niso nujno povezane z zmanjšano klinično učinkovitostjo linkomicina (Lanckriet et al., 2010)2.
English: Metabolites comprised more than 75% of total residues in the liver.
Slovenian: Presnovki so predstavljali več kot 75% vseh ostankov v jetrih.
English: Tissue residues levels were measured in composite samples from 4 birds at 0, 2 and 7 days after the end of treatment.
Slovenian: Raven ostankov v tkivu so izmerili v sestavljenih vzorcih iz 4 ptic, odvzetih 0, 2 in 7 dni po koncu zdravljenju.
English: Similar results were observed following single oral doses of 4.4 and 11.0 mg/kg body weight in pigs.
Slovenian: Podobne rezultate so opazili po enkratnih peroralnih odmerkih 4,4 in 11,0 mg / kg telesne mase pri prašičih.
English: This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the product Lincocin and its associated names.
Slovenian: To vrednotenje koristi in tveganja je bilo opravljeno v okviru člena 34 Direktive 2001/82/ES, ki je v tem postopku namenjen uskladitvi pogojev za izdajo dovoljenja za zdravilo Lincocin in z njim povezanih imen v EU.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe, imetnikov dovoljenja za promet v državah članicah
English: However, as the dosing regimens and indications have not been extended, there is no increase in the exposure of the environment to the active substance.
Slovenian: Ker se sheme odmerjanja in indikacije niso razširile, se izpostavljenost okolja zdravilni učinkovini ne poveča.
English: If respiratory symptoms develop following exposure, seek medical advice and show this warning to the physician.
Slovenian: Če se po izpostavitvi pojavijo dihalni simptomi, poiščite zdravniško pomoč in to opozorilo pokažite zdravniku.
English: Use of the veterinary medicinal product preferably should be based on identification of the target pathogen and susceptibility testing of the bacteria isolated from the animal.
Slovenian: Uporaba zdravila mora prednostno temeljiti na identifikaciji ciljnega patogena in občutljivostnih testih bakterij, izoliranih iz živali.
English: In case of accidental exposure to the skin, eyes or mucous membranes, wash the affected area thoroughly with plenty of water.
Slovenian: V primeru nenamernega kontakta s kožo, očmi ali sluznicami, temeljito sperite prizadeto območje z veliko vode.
English: Evaluation and conclusions on the benefit-risk balance
Slovenian: Vrednotenje in zaključki o razmerju med tveganji in koristmi
English: Resistance can be a direct concern when affecting zoonotic pathogens such as Campylobacter and Enterococcus, or can be transferred horizontally to human pathogens via mobile genetic elements.
Slovenian: Odpornost je lahko neposredno zaskrbljujoča, če se pojavi pri povzročiteljih zoonoz, kot sta Campylobacter in Enterococcus, ali če se je zmožna horizontalno prenesti na človeške bolezenske povzročitelje prek mobilnih genskih elementov.
English: • The revised harmonised SPC of Lincocin contains the necessary information to ensure the safe and effective use of the product.
Slovenian: • Usklajen in popravljen povzetek glavnih značilnosti zdravila Lincocin vsebuje potrebne informacije za zagotavljanje varne in učinkovite uporabe zdravila.
English: 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.
Slovenian: 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.
English: The dosage of 3.9 mg/kg body weight was investigated in another two trials with similar designs, under simulated natural conditions.
Slovenian: Odmerjanje 3,9 mg/kg telesne mase so proučili v dveh preskušanjih s podobno zasnovo v simuliranih naravnih pogojih.
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Slovenian: Pri uporabi zdravila za uporabo v veterinarski medicini je treba upoštevati uradne, nacionalne in regionalne protimikrobne smernice.
English: 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.
Slovenian: 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.
English: High concentrations of the active form are observed in the intestine.
Slovenian: V črevesju opazimo visoke koncentracije aktivne oblike.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Shelf life after dilution or reconstitution according to directions: 24 hours.
Slovenian: Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili: 24 ur.
English: Lincomycin may be either bactericidal or bacteriostatic.
Slovenian: Linkomcin lahko deluje baktericidno ali bakteriostatično.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: People with known hypersensitivity to lincomycin or any other lincosamide, or to lactose monohydrate, should avoid contact with the veterinary medicinal product.
Slovenian: Ljudje, pri katerih je znana preobčutljivost na linkomicin ali ostale linkozamide ali na laktozo monohidrat, se morajo izogibati stiku s tem zdravilom.
English: Wash hands and any exposed skin with soap and water immediately after use.
Slovenian: Takoj po uporabi si umijte roke in izpostavljeno kožo z milom in vodo.
English: Given the results from the provided residue depletion study and the calculations made by the CVMP, a withdrawal period of 1 day was recommended.
Slovenian: Glede na rezultate predložene študije o izločanju ostankov in izračune odbora CVMP je bila priporočena karenca en dan.
English: This product contains lincomycin and lactose monohydrate, either of which can cause allergic reactions in some people.
Slovenian: To zdravilo vsebuje linkomicin in laktozo monohidrat, ki lahko pri ljudeh povzročata alergične reakcije.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The bioavailability of lincomycin may decrease in the presence of gastric antacids or activated charcoal, pectin or kaolin.
Slovenian: Biološka razpoložljivost linkomicina se lahko zmanjša v prisotnosti želodčne kisline ali aktivnega oglja, pektina ali kaolina.
English: Shelf life after first opening the container: use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
English: Lincomycin can potentiate neuromuscular effects of anaesthetics and muscle relaxants.
Slovenian: Linkomicin lahko potencira nevromuskularne učinke anestetikov in mišičnih relaksansov.
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Piščancem so dajali linkomicinijev klorid v pitni vodi na ravni približno 34 mg / 1L (5,1-6,6 mg / kg telesne mase) sedem dni.
English: 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.
Slovenian: 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.
English: Do not mix with any other veterinary medicinal product
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Na podlagi predložene dokumentacije se je predlagana karenca pet dni za piščančje meso in drobovino štela za varno za potrošnike.
English: 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.
Slovenian: 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.
English: Approximately 50% of lincomycin is metabolised in the liver.
Slovenian: Približno 50% linkomicina se presnavlja v jetrih.
English: Satisfactory withdrawal periods have been set to provide assurance of consumer safety.
Slovenian: Določene so bile zadovoljive karence, ki zagotavljajo varnost potrošnikov.
English: 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.
Slovenian: 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.
English: A withdrawal period of 1 day was therefore recommended for pig meat and offal as this gives a sufficient margin of safety.
Slovenian: Za prašičje meso in drobovino je priporočljiva karenca 1 dan, saj zagotavlja zadostno raven varnosti.
English: 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.
Slovenian: 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.
English: For this reason the above study could be accepted for the determination of the chicken meat and offal withdrawal period for Lincocin.
Slovenian: Zaradi navedenega bi lahko študijo sprejeli za določitev obdobja karence za piščančje meso in drobovino za zdravilo Lincocin.
English: However, the most prevalent mechanism in mycoplasmas is the alteration of the binding site through mutational events (chromosomal resistance).
Slovenian: Vendar je najpogostnejši mehanizem v mikoplazmah sprememba mesta vezave z mutacijskimi dogodki (kromosomska odpornost).
English: 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.
Slovenian: 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.
English: In case of accidental overdose, the treatment must be stopped and restarted at the recommended dose level.
Slovenian: V primeru nenamernega prevelikega odmerjanja, prenehajte z zdravljenjem in ponovno začnite s priporočenim odmerkom.
English: The following indications for Lincocin and its associated names can be supported based on the data provided:
Slovenian: Na podlagi predloženih podatkov je mogoče podpreti naslednje indikacije za zdravilo Lincocin in z njim povezana imena:
English: Do not use in cases of known resistance to lincosamides.
Slovenian: Ne uporabite v primeru rezistence na linkozamide.
English: 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):
Slovenian: 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:
English: It might be the case that local intestinal concentrations of lincomycin exceed the MIC of non-wild-type isolates.
Slovenian: Morda je to posledica višjih lokalnih koncentracij linkomicina v črevesju, ki presegajo vrednosti MIK pri izolatih, ki niso divji tipi.
English: 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.
Slovenian: 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.