FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Ova procjena koristi i rizika provedena je u kontekstu članka 34.Direktive 2001/82/EZ koji u sadašnjem postupku ima svrhu postići usklađenost uvjeta odobrenja za VMP Lincocin i pridružena imena unutar EU-a.
English: While the lincosamides are generally considered to be bacteriostatic agents, the activity depends on the sensitivity of the organism and concentration of the antibiotic.
Croatian: I dok se linkozamidi općenito smatraju bakteriostatskim tvarima, djelotvornost ovisi o osjetljivosti organizama i koncentraciji antibiotika.
English: 02-676 Warsaw
Croatian: Postępu 17B 02-676 Warsaw Poljska
English: Repeated or prolonged use should be avoided by improving the farm management and hygiene practices.
Croatian: ponovnu ili produženu primjenu treba izbjegavati poboljšanjem upravljanja farmom i higijenskom praksom.
English: Peak serum levels were observed at 4 hours after dosing.
Croatian: Vršne razine u serumu uočene su 4 sata nakon doziranja.
English: At 2 days after the end of treatment, residues in liver, kidney and muscle were all below the MRLs.
Croatian: Dva dana nakon završetka liječenja, svi rezidui u jetri, bubregu i mišićima bili su ispod NDK-a.
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.
Croatian: Prilikom usporedbe s novijim EU izolatima (2011.2016.), distribucije MIK-ova su slične, tromodalne s vrhovima koji su se razlikovali za najviše jedno dvostruko razrjeđivanje.
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.
Croatian: S obzirom na rezultate dostavljene za ispitivanje deplecije rezidua i izračune koje je proveo CVMP, preporučuje se karencija od 1 dana.
English: Risks for users were considered low and adequate information is included in the product information to ensure the safety for the user.
Croatian: Rizici za korisnike smatraju se malim, a u informacije o VMP-u uključene su odgovarajuće informacije kako bi se zajamčila sigurnost primjene za korisnike.
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.
Croatian: To je premašilo minimalnu učinkovitu dozu (3,9 mg/kg) koja je utvrđena u ispitivanju procjene doze i bilo je unutar ispitanog raspona u ispitivanjima potvrde doze i sigurnosnim ispitivanjima primjene u ciljnih životinja.
English: However, there was no definitive evidence that strains of C. perfringens with high MICs for lincomycin may be clinically resistant.
Croatian: Međutim, nije bilo definitivnog dokaza da sojevi C. perfringens s visokim MIK-ovima za linkomicin mogu biti klinički rezistentni.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu ili nuspojave koje nisu već opisane u uputi o VMP, ili mislite da veterinarsko medicinski proizvod nije djelovao, molimo obavijestite svog veterinara.
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.
Croatian: Na temelju dostavljene dokumentacije, predloženo razdoblje karencije od 5 dana za meso i iznutrice pilića smatra se sigurnim za potrošače.
English: The description and validation of the GC/MS analytical method was considered acceptable.
Croatian: Opis i validacija pomoću analitičke metode plinske kromatografije / masene spektrometrije (GC/MS) smatrala se prihvatljivom.
English: The excreta contained mostly unmetabolised lincomycin (60-85%) during treatment.
Croatian: Ekskreti su tijekom liječenja uglavnom sadržavali nemetabolizirani linkomicin (60-85%).
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.
Croatian: Rizici povezani s primjenom Lincocina i pridruženim imenima jesu oni koji se općenito pripisuju antimikrobnim lijekovima koji se primjenjuju u životinja namijenjenih za proizvodnju hrane, tj. razvoj antimikrobne rezistencije u ciljnoj bakteriji, širenje rezistentne bakterije / faktori rezistencije itd.
English: On rare occasions some pigs may show reddening of the skin and mild irritable behaviour.
Croatian: U rijetkim slučajevima neke svinje mogu imati crvenilo kože i blago razdražljivo ponašanje.
English: Lincomycin is eliminated unchanged or in the form of various metabolites in bile and urine.
Croatian: Linkomicin se izlučuje nepromijenjen ili u obliku različitih metabolita u žući i mokraći.
English: 470,6 mg lincomycin HCl/g (corresponding to 400 mg lincomycin/g)
Croatian: 470,6 mg linkomicin HCl/g (odgovara 400 mg linkomicina/g)
English: In pigs, lincomycin is rapidly absorbed following oral administration.
Croatian: U svinja, linkomicin se brzo resorbira nakon oralne primjene.
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.
Croatian: Osim toga, starija ispitivanja provedena s Lincocinom u pilića, a u kojima se mjerenje rezidua provodilo mikrobiološkom metodom, daju dodatnu sigurnost da je karencija od 5 dana sigurna za potrošače.
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.
Croatian: 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 sadašnji postupak, CVMP je zaključio da tu indikaciju treba izbrisati i iz informacija o VMP-u za Lincocin.
English: Do not mix with any other veterinary medicinal product
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: Wash hands and any exposed skin with soap and water immediately after use.
Croatian: Odmah nakon primjene operite ruke i bilo koji dio izložene kože sapunom i vodom.
English: Laboratory studies in rats have not produced any evidence of teratogenic effects, although foetotoxicity has been reported.
Croatian: Laboratorijski pokusi na štakorima nisu pružili nikakav dokaz teratogenih učinaka, iako je zabilježena fetotoksičnost.
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).
Croatian: Makrolidni, linkozamidni i streptograminski antimikrobni lijekovi na popisu su Svjetske zdravstvene organizacije (2017.)3 kao kritično važni za liječenje određenih zoonotskih infekcija u ljudi (kao što su infekcije prouzročene bakterijom Campylobacter).
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.
Croatian: Postoje starija ispitivanja koja su provedena primjenom mikrobioloških metoda i pokazuju da razdoblje karencije od nula dana može biti odgovarajuće; međutim, za ta se ispitivanja ne smatra da su provedena po sadašnjim standardima.
English: In case of accidental exposure to the skin, eyes or mucous membranes, wash the affected area thoroughly with plenty of water.
Croatian: U slučaju nehotičnog izlaganja kože, očiju ili sluznica, zahvaćena područja temeljito isperite većom količinom vode.
English: It might be the case that local intestinal concentrations of lincomycin exceed the MIC of non-wild-type isolates.
Croatian: Možda se radi o tome da lokalne crijevne koncentracije linkomicina premašuju MIK izolata koji nisu divljeg tipa.
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.
Croatian: Međutim, u svjetlu činjenice da je u opisanom ispitivanju doza linkomicina bila nekoliko puta viša od preporučene doze Lincocina, a trajanje liječenja bilo je slično, smatralo se da to ispitivanje pruža prilično konzervativan rezultat iako mogućnost farmakokinetičkih interakcija između linkomicina i spektinomicina nije bila opisana.
English: The dosage of 3.9 mg/kg body weight was investigated in another two trials with similar designs, under simulated natural conditions.
Croatian: Doza od 3,9 mg/kg tjelesne težine ispitivana je u dva druga slično ustrojena ispitivanja u simuliranim prirodnim uvjetima.
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.
Croatian: Valja napomenuti da ne postoje nikakvi standardizirani postupci za testiranje MIK-a antimikrobnih agensa protiv mikoplazmi i nikakve kliničke prijelomne točke, što je otežalo usporedbu rezultata dobivenih u različitim ispitivanjima.
English: The use of suitably calibrated weighing equipment is recommended if part packs are used.
Croatian: Ako se koristi dio pakiranja preporučuje se korištenje odgovarajuće kalibrirane opreme za vaganje.
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.
Croatian: Upotrijebljena doza (približno 10 mg linkomicina/kg tjelesne težine na dan primijenjeno u vodi za piće) smatrala se reprezentativnom za najveću količinu linkomicina preporučenu za VMP.
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.
Croatian: Budući da CVMP nije predložio veće režime doziranja, a indikacije nisu proširene u odnosu na one odobrene u većini sažetaka opisa svojstava VMP-a, procjena sigurnosti ciljnih vrsta životinja i sigurnost potrošača nisu predstavljale nova sigurnosna pitanja.
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.
Croatian: Linkomicin se veže na 50S podjedinicu bakterijskog ribosoma blizu centra peptidil transferaze i ometa proces produživanja peptidnog lanca tako što uzrokuje preuranjeno odvajanje peptidil-tRNA od ribosoma.
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.
Croatian: Međutim, uzimajući u obzir varijabilnost unosa djelatne tvari koja može biti posljedica doziranja putem vode za piće te dobar sigurnosni profil linkomicina, doza veća od minimalne učinkovite doze smatrala se opravdanom.
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.
Croatian: Nakon prolaska crijevne barijere, linkomicin se na široko raspoređuje u sva tkiva, posebno u pluća i zglobne šupljine; volumen raspodjele je otprilike 1 L.
English: Satisfactory withdrawal periods have been set to provide assurance of consumer safety.
Croatian: Određena su zadovoljavajuća razdoblja karencije kako bi se osigurala sigurnost potrošača.
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.
Croatian: S obzirom na podatke o osjetljivosti in vitro, iako nema standardizirane metodologije kojom bi se odredio MIK za antibiotike protiv B. hyodysenteriae, bilo je očito da je većina izolata izvan populacije prividno divljeg tipa.
English: • Indications
Croatian: • indikacije
English: Bottle of 150 g Bottle of 1.5 kg
Croatian: Bočica od 150 g Boca od 1,5 kg
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
Croatian: Na temelju rezultata ispitivanja i izračuna koje je proveo CVMP, zaključeno je da razdoblje karencije od nula dana za meso i iznutrice svinja možda nije sigurno za potrošače jer je prva vremenska točka na kojoj su svi uzorci bili ispod najveće dopuštene količine rezidua (NDK) iznosila
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.
Croatian: Suvremeno ispitivanje deplecije rezidua provedeno je s topljivim praškom koji sadrži kombinaciju linkomicina i spektinomicina, a doza linkomicina koja je primijenjena bila je otprilike 3 do 5 puta viša od preporučene doze Lincocina.
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.
Croatian: Razmotrivši razloge arbitražnog postupka i podatke koje je dostavio nositelj odobrenja, CVMP je zaključio da omjer koristi i rizika ostaje pozitivan za primjenu u svinja i pilića uz predložene promjene u informacijama o VMP-u.
English: One composite muscle sample out of three had residues slightly above the MRL (57 µg/kg versus 50 µg/kg).
Croatian: Jedan od tri kompozitna uzorka mišića imao je rezidue neznatno iznad NDK-a (57 µg/kg naspram 50 µg/kg).
English: Administration conditions: Administration under the control or direct responsibility of a veterinary surgeon.
Croatian: Uvjeti primjene: primjena pod kontrolom ili izravnom odgovornošću veterinara.
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):
Croatian: Osim toga, CVMP je smatrao da u dio 4.4 „Posebna upozorenja za svaku od ciljnih vrsta životinja” sažetka opisa svojstava VMP-a (SPC) treba dodati sljedeće upozorenje:
English: Therefore, the high in vitro resistance level in B. hyodysenteriae constitutes a major uncertainty as to the clinical effectiveness of Lincocin.
Croatian: Zbog toga, visoka in vitro otpornost bakterije B. hyodysenteriae predstavlja najveću nesigurnost u pogledu kliničke učinkovitosti lijeka Lincocin.
English: For this reason the above study could be accepted for the determination of the chicken meat and offal withdrawal period for Lincocin.
Croatian: Zbog toga se prethodno spomenuto ispitivanje može prihvatiti za određivanje razdoblja karencije za meso i iznutrica pilića prilikom primjene Lincocina.
English: Lincomycin undergoes enterohepatic circulation.
Croatian: Linkomicin prolazi enterohepatičnu cirkulaciju.
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.
Croatian: Iako su ispitivanja provedena u SAD-u tijekom 1980.-ih, a ni za jedno od dva ispitivanja nisu poznati MIK-ovi izolata odgovornih za nekrotični enteritis, nositelj odobrenja odredio je MIK-ove za izolate C. perfringens dobivene iz pilića u SAD-u tijekom 1990.-ih.
English: Tissue residues levels were measured in composite samples from 4 birds at 0, 2 and 7 days after the end of treatment.
Croatian: Rezidui u tkivima izmjereni su u kompozitnim uzorcima uzetim od 4 pilića 0, 2 i 7 dana nakon završenog liječenja.
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.
Croatian: Kao zaključak, uzevši u obzir da se obrazac osjetljivosti C. perfringens na linkomicin nije značajno promijenio u proteklih 25 godina, da nema definitivne korelacije između MIK-ova i kliničke djelotvornosti te u kontekstu ovog postupka, CVMP je smatrao da je indikacija odgovarajuće opravdana i da stoga pilići mogu ostati ciljna vrsta.
English: Pharmacotherapeutic group: Antibacterials for systemic use; Lincosamides.
Croatian: Farmakoterapijska grupa: antibiotici za sustavnu primjenu; linkozamidi.
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.
Croatian: Sveukupno gledano, uzimajući u obzir opseg postupka mišljenje CVMP-a bilo je da je indikacija „liječenje i metafilaksa enzootske pneumonije prouzročene bakterijom Mycoplasma hyopneumoniae” odgovarajuće opravdana.
English: The indication against swine dysentery caused by B. hyodysenteriae could no longer be maintained and was removed.
Croatian: Indikacija protiv dizenterije u svinja prouzročene bakterijom B. hyodysenteriae nije se mogla zadržati te je uklonjena.
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.
Croatian: Europska komisija poslala je 5. srpnja 2016. godine Europskoj agenciji za lijekove obavijest o arbitražnom postupku za Lincocin i pridružena imena prema članku 34.
English: • the CVMP reviewed the summary of product characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data;
Croatian: • CVMP je ocijenio sažetak opisa svojstava, označivanje i uputu o VMP-u koje predlaže nositelj odobrenja i razmotrio sve dostavljene podatke;
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.
Croatian: Može postojati antagonizam između linkomicina i makrolida kao što je eritromicin i ostalih baktericidnih antibiotika; istodobna primjena se stoga ne preporučuje zbog konkurentnog vezanja na 50S ribosomalnu podjedinicu bakterijske stanice.
English: Use only according to the benefitrisk assessment by the responsible veterinarian.
Croatian: Primijeniti samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara.
English: Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Croatian: Ne primjenjivati u slučaju poznate preosjetljivosti na djelatnu tvar ili na bilo koju od pomoćnih tvari.
English: On rare occasions, pigs given lincomycin-medicated water may develop diarrhoea/soft stools and/or mild swelling of the anus within the first 2 days after onset of treatment.
Croatian: U rijetkim slučajevima svinje kojima je dana voda s linkomicinom mogu dobiti proljev/mekani izmet i/ili blago oticanje anusa unutar prva 2 dana od početka liječenja.
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.
Croatian: Stoga, smatralo se da se predloženo razdoblje karencije od 5 dana može uzeti kao razdoblje sigurno za preporučeni režim doziranja od 5 mg linkomicina po kg tjelesne težine na dan tijekom 7 dana.
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.
Croatian: U pogledu kliničkih podataka, nekoliko ispitivanja koje je dostavio nositelj odobrenja provedeno je s formulacijom linkomicina u hrani.
English: The harmonised warnings and precautions proposed in the product information were considered adequate to ensure safety to users of the product.
Croatian: Usklađena upozorenja i mjere opreza predloženi u informacijama o VMP-u, smatrali su se odgovarajućim jamstvom sigurnosti korisnika VMP-a.
English: = ___ mg product per litre drinking water
Croatian: = mg proizvoda po litri vode za piće
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.
Croatian: Kokošima je primijenjen linkomicin hidroklorid u vodi za piće u razini od približno 34 mg/litri (5,16,6 mg/kg tjelesne mase) kroz sedam dana.
English: Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Croatian: Linkomicin je linkozamidni antibiotik dobiven od Streptomyces lincolnensis koji inhibira sintezu proteina.
English: A withdrawal period of 1 day was therefore recommended for pig meat and offal as this gives a sufficient margin of safety.
Croatian: Stoga je za meso i iznutrice svinja preporučeno razdoblje karencije od 1 dana jer je time dosegnuta dovoljna granica sigurnosti.
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.
Croatian: Omjer koristi i rizika prilikom primjene Lincocina protiv dizenterije u svinja prouzročene B. hyodysenteriae smatra se negativnim zbog razvoje stečene rezistencije i visoke nesigurnosti o njezinom utjecaju u smislu djelotvornosti in vivo.
English: Hungary Zoetis Hungary Kft. Budapest, Alkotás u.
Croatian: Budapest, Alkotás u.
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Croatian: Kad se primjenjuje veterinarsko medicinski proizvod u obzir treba uzeti službene, nacionalne i regionalne antimikrobne smjernice.
English: Shelf life after dilution or reconstitution according to directions: 24 hours.
Croatian: Rok valjanosti poslije razrjeđenja ili rekonstitucije prema uputi: 24 sata.
English: Unmetabolised lincomycin declined at a slightly faster half-life (t½ = 5.8 hours) than total residue.
Croatian: Nemetabolizirani linkomicin opada pri malo bržem poluživotu (t½ = 5,8 sati) u odnosu na ukupne rezidue.