FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Osim toga, tekst dijela 4.9 „Količine koje se primjenjuju i put primjene” sažetka opisa svojstava VMP-a bio je opsežno modificiran, s glavnim ciljem da se postigne veća jasnoća.
English: the CVMP has recommended the amendment of the marketing authorisations for Lincocin and its associated names as referred in Annex I for which the summary of product characteristics, labelling and package leaflet are set out in Annex III.
Croatian: CVMP preporučuje izmjenu i dopunu odobrenja za stavljanje lijeka u promet za Lincocin i pridružene nazive kao što je navedeno u Prilogu I., za koji su sažetak opisa svojstava, označivanje i uputa o VMP-u navedeni u Prilogu III.
English: The CVMP noted that a residue depletion study using Lincocin itself (or a bioequivalent product) would have been preferable.
Croatian: CVMP je napomenuo da bi bilo poželjno provesti ispitivanje deplecije rezidua primjenjujući samo Lincocin (ili bioekvivalentan lijek).
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.
Croatian: Međutim, kako su farmakokinetički parametri bili veći kod primjene topljivog praška, a i općenito se smatra da će topljivi prašak rezultirati boljom biološkom raspoloživošću djelatne tvari u usporedbi s formulacijom u hrani, CVMP je prihvatio da se klinički rezultati koji se odnose na formulacije u smjesi mogu proširiti i na topljivi prašak.
English: Lincomycin resistance mediated by efflux pumps, or by inactivating enzymes, has also been described.
Croatian: Također je opisana rezistencija na linkomicin posredovana efluksnim pumpama, ili inaktivacijskim enzimima.
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.
Croatian: Bijela bočica od polietilena visoke gustoće (HDPE) koja sadrži 150 g ili 1,5 kg praška za upotrebu u vodi za piće s poklopcem od polietilena niske gustoće (LDPE).
English: MANUFACTURER'S BATCH NUMBER Lot {number}:
Croatian: 17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: Do not use in cases of hepatic dysfunction.
Croatian: Ne primjenjivati u slučajevima jetrene disfunkcije.
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.
Croatian: Dostavljeni klinički podatci pokazali su da je Lincocin učinkovit za liječenje dizenterije u svinja prouzročene bakterijom B. hyodysenteriae; međutim, ispitivanja o kojima je riječ provedena su u razdoblju od 1977. do 1993., a vrijednosti MIK-a nisu bile određene u većini dostavljenih kliničkih ispitivanja.
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.
Croatian: Za neka ispitivanja u kojima je linkomicin primjenjivan u hrani smatralo se da dokazuju terapijski i/ili metafilaktički učinak linkomicina protiv enzootske pneumonije.
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.
Croatian: Primjena veterinarsko - medicinskog proizvoda trebala bi se prije svega temeljiti na identifikaciji ciljnog patogena i testu osjetljivosti bakterije izolirane kod životinja.
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.
Croatian: Ponovno doziranje kod svinja s dnevnim oralnim dozama od 22 mg linkomicina/kg tjelesne mase kroz 3 dana ne ukazuje na nakupljanje linkomicina u ove vrste, bez detektibilnih razina antibiotika u serumu 24 sata nakon primjene.
English: Do not use in cases of known resistance to lincosamides.
Croatian: Ne primjenjivati u slučajevima poznate rezistencije na linkozamide.
English: The following indications for Lincocin and its associated names can be supported based on the data provided:
Croatian: Na temelju dostavljenih podataka, moguće je potkrijepiti sljedeće indikacije za Lincocin i pridružena imena:
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.
Croatian: Jednokratna oralna primjena linkomicin hidroklorida, u razinama doze od približno 22, 55 i 100 mg/kg tjelesne mase u svinja, rezultirala je razinama linkomicina u serumu ovisnim o dozi, detektiranim 24-36 sati nakon primjene.
English: None.
Croatian: Nema
English: It was concluded that the susceptibility pattern of C. perfringens to lincomycin has not changed significantly over the last 25 years.
Croatian: Zaključeno je da se obrazac osjetljivosti C. perfringens na linkomicin nije značajno promijenio u proteklih 25 godina.
English: Overall summary of the scientific evaluation of Lincocin and its associated names (see Annex I)
Croatian: Cjelokupni sažetak znanstvene ocjene veterinarskomedicinskog proizvoda Lincocin i pridruženih imena (vidjeti Dodatak I)
English: It is bacteriostatic and primarily active against Gram-positive bacteria (both aerobic and anaerobic), Gram-negative anaerobic bacteria and mycoplasma.
Croatian: To je bakteriostatik, a djeluje prvenstveno protiv gram-pozitivnih bakterija (aerobnih i anaerobnih), gram-negativnih anaerobnih bakterija i mikoplazmi.
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.
Croatian: To se činilo u skladu s doziranjem procijenjenim u dostavljenim ispitivanjima, međutim, dvostruki raspon doza bez jasnih uputa korisniku o tome kada primijeniti lijek u višem ili nižem rasponu, smatrao se zbunjujućim.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottles containing 150 g or 1.5 kg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Boce koje sadrže 150 g ili 1.5 kg
English: Dosage (mg product per kg body weight per day)
Croatian: Doziranje (mg proizvoda po kg tjelesne mase na dan)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 liječenih životinja pokazuje nuspojave) - česte (više od 1, ali manje od 10 životinja na 100 liječenih životinja) - manje česte (više od 1, ali manje od 10 životinja na 1.000 liječenih životinja) - rijetke (više od 1, ali manje od 10 životinja na 10.000 liječenih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
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.
Croatian: Ako se nakon izlaganja pojave simptomi poput kožnog osipa ili trajnog nadražaja očiju, odmah zatražite savjet liječnika i pokažite mu upute o VMP-u ili etiketu.
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.
Croatian: S obzirom na određivanje razdoblja karencije, s Lincocinom nisu u pilića provedena ispitivanja deplecije rezidua upotrebom suvremene (HPLC) metode testiranja.
English: A single oral dose of 10 mg/kg body weight was administered to pigs to determine the bioavailability.
Croatian: Jednokratna oralna doza od 10 mg/kg tjelesne težine primijenjena je svinjama kako bi se odredila bioraspoloživost.
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.
Croatian: Nositelj odobrenja dostavio je također dodatne podatke iz jednog ispitivanja u kojem se djelotvornost linkomicina, u obliku topljivog praška primjenjivanog u vodi za piće svinjama, istraživala na farmi za koju su bili poznati problemi s enzootskom pneumonijom.
English: The oral absorption of lincomycin was found to be 53% ± 19%.
Croatian: Utvrđeno je da je oralna resorpcija linkomicina 53%
English: Pigs, poultry (broilers)
Croatian: Svinje, perad (brojleri)
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.
Croatian: Iako ti rizici nisu bili nedvosmisleno procijenjeni, postoji stvarna mogućnost utjecaja na ljudsko zdravlje zbog križne rezistencije na klindamicin i druge tvari iz skupine makrolida, linkozamida i streptogramina.
English: Mean body weight (kg) of animals to be treated
Croatian: prosječna tjelesna masa (kg) životinja koje će se liječiti
English: Evaluation and conclusions on the benefit-risk balance
Croatian: Procjena i zaključci o omjeru koristi i rizika
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.
Croatian: Ipak, na temelju dostavljenih podataka za MIK, uključujući ispitivanje koje je proveo nositelj odobrenja 2016., može se zaključiti da se u posljednjih 20 - 25 godina obrazac osjetljivosti bakterije M. hyopneumoniae na linkomicin nije značajno promijenio.
English: Medicated drinking water should be freshly prepared every 24 hours.
Croatian: Svaka 24 sata treba pripremati svježu vodu za piće s veterinarsko medicinskim proizvodom.
English: There is often complete cross-resistance between lincomycin and clindamycin.
Croatian: Česta je kompletna križna rezistencija između linkomicina i klindamicina.
English: Cherrywood Business Park
Croatian: Cherrywood Business Park Loughlinstown Co.
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.
Croatian: Unatoč tome što ne postoje standardizirani postupci za testiranje vrijednosti MIK-a antimikrobnih agensa protiv mikoplazmi i kliničke prijelomne točke, na temelju dostavljenih podataka za MIK može se zaključiti da se u proteklih 20 - 25 godina obrazac osjetljivosti bakterije M. hyopneumoniae na linkomicin nije značajno promijenio.
English: Based on the observed depletion pattern, a 5-day withdrawal period was shown to be appropriate for the combination product.
Croatian: Na temelju opaženog obrasca deplecije pokazalo se da je petodnevno razdoblje karencije odgovarajuće za kombinirani lijek.
English: Lincocin is a powder for oral solution containing 400 mg lincomycin per gram product.
Croatian: Lincocin je prašak za oralnu otopinu koji sadrži 400 mg linkomicina po gramu lijeka.
English: Shelf life after first opening the container: use immediately.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: odmah upotrijebiti.
English: The dosing regimen for the indication was not changed and remained at 10 mg lincomycin/kg body weight daily for 21 consecutive days.
Croatian: Režim doziranja za indikaciju nije izmijenjen i ostao je 10 mg linkomicina/kg tjelesne težine dnevno, uzastopno tijekom 21 dana.
English: The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay in the target species.
Croatian: Sigurnost veterinarsko medicinskog proizvoda nije utvrđena tijekom graviditeta,
English: Lincomycin can potentiate neuromuscular effects of anaesthetics and muscle relaxants.
Croatian: Linkomicin može potencirati neuromuskularni učinak anestetika i miorelaksansa.
English: Lincocin 40% Lincomycin (as lincomycin hydrochloride)
Croatian: Lincocin 40% Linkomicin (u obliku linkomicin hidroklorida)
English: A dosage greater than 10 mg lincomycin per kg of body weight may cause diarrhoea and loose stools in pigs.
Croatian: Doze veće od 10 mg linkomicina na kilogra mtjelesne težine mogu uzrokovati proljev i mekani izmet kod svinja.
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.
Croatian: Dio 4.9 „Količine koje treba primijeniti i put primjene” sažetka opisa svojstava VMP-a ipak je izmijenjen, uglavnom radi bolje jasnoće.
English: Lincomycin is active against some gram-positive bacteria (Clostridium perfringens) and mycoplasmas (Mycoplasma hyopneumoniae).
Croatian: Linkomicin djeluje protiv nekih gram-pozitivnih bakterija (Clostridium perfringens) i mikoplazmi (Mycoplasma hyopneumoniae).
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.
Croatian: U ispitivanju titracije doza istraživao se terapijski učinak različitih razina linkomicina primijenjenog u vodi za piće protiv nekrotičnog enteritisa u tovnih pilića u simuliranim prirodnim uvjetima.
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1
Croatian: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-laNeuve
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.
Croatian: Direktive 2001/82/EZ provedenom za sve veterinarsko-medicinske proizvode koji sadrže kombinaciju linkomicina i spektinomicina za peroralnu primjenu u svinja ili pilića (EMEA/V/A/110)1, CVMP je zaključio da indikacije koje se odnose na dizenteriju u svinja prouzročenu bakterijom B. hyodysenteriae nisu bile dovoljno potkrijepljene te ih je potrebno izbrisati iz informacija o VMP-u.
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.
Croatian: Za piliće, postojeća odobrena doza i doza prema usklađenom prijedlogu iznosi 3 - 6 mg linkomicina po kg tjelesne težine dnevno tijekom 7 uzastopnih dana.
English: The active substance lincomycin is a lincosamide antibiotic and is produced by Streptomyces lincolnensis.
Croatian: Djelatna tvar linkomicin je linkozamidni antibiotik, a proizvodi ga Streptomyces lincolnensis.
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.”
Croatian: Gdje je moguće, terapija se treba temeljiti na lokalnim (regionalnim, na razini uzgoja) epidemiološkim informacijamao odgovoru enzootske pneumonije / nekrotičnog enteritisa na liječenje linkomicinom.“
English: However, the most prevalent mechanism in mycoplasmas is the alteration of the binding site through mutational events (chromosomal resistance).
Croatian: Međutim, najčešći mehanizam u mikoplazmama je izmjena mjesta vezanja putem mutacija (kromosomalna rezistencija).
English: TARGET SPECIES Pigs and chickens.
Croatian: CILJNE VRSTE ŽIVOTINJA Svinje i kokoši.
English: • the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
Croatian: • opseg arbitražnog postupka odnosi se na usklađivanje sažetaka opisa svojstava, označivanje i upute o VMP-u;
English: Medicated drinking water uptake can be affected by the severity of the disease.
Croatian: Na unos vode za piće s veterinarsko medicinskim proizvodom može utjecati težina bolesti.
English: Oral use (via drinking water)
Croatian: Oralna primjena (putem vode za piće)
English: Colloidal anhydrous silica Lactose monohydrate
Croatian: Laktoza monohidrat
English: “The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints.
Croatian: „Osjetljivost bakterije Mycoplasma hyopneumoniae na antimikrobne agense teško je testirati in vitro zbog tehničkih ograničenja.
English: Lincocin Soluble Powder 400 mg/g Powder for Oral Solution
Croatian: Lincocin Soluble Powder 400 mg/g Prašak za oralnu primjenu
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.
Croatian: CVMP je priznao teškoće s određivanjem jedinstvene doze i složio se da je prijedlog doze od 5 mg linkomicina po kg tjelesne težine tijekom 7 dana prihvatljiv, iako je donekle proizvoljno izabran.
English: In addition, there is a the lack of clinical breakpoints for both M. hyopneumoniae and C. perfringens.
Croatian: Dodatno, postoji nedostatak kliničkih graničnih vrijednosti za M. hyopneumoniae i C. perfringens.
English: • Target species
Croatian: • ciljne vrste životinja
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.
Croatian: Ne primjenjujte i onemogućite pristup vodi koja sadrži linkomicin, kunićima, hrčcima, zamorčadi, činčilama, konjima ili preživačima, jer to može rezultirati teškim gastrointestinalnim poremećajem.
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.
Croatian: Za kokoši nesilice nema podataka koji bi potkrijepili razdoblje karencije za jaja; stoga upotreba lijeka ne smije biti odobrena u peradi čija su jaja namijenjena za konzumaciju.
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.
Croatian: Primjena veterinarsko medicinskog proizvoda koja odstupa od uputa danih u sažetku opisa svojstava može povećati prevalenciju bakterijske rezistencije na linkomicin te može smanjiti učinkovitost liječenja s ostalim linkozamidima, makrolidima i streptograminom B zbog moguće križne rezistencije.
English: Pigs were already authorised as a target species for all products concerned by this referral procedure.
Croatian: Svi lijekovi na koje se odnosi ovaj arbitražni postupak već su bili odobreni za svinje kao ciljnu vrstu životinja.
English: The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints.
Croatian: Osjetljivost Mycoplasma hyopneumoniae na antimikrobne tvari teško je testirati in vitro zbog tehničkih ograničenja.
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.
Croatian: Kod rukovanja i miješanja proizvoda treba nositi osobnu zaštitnu opremu koja se sastoji od odobrenih maski protiv prašine (ili jednokratni respirator polumaska, sukladan europskoj normi EN149 ili višekratni respirator EN 140 s filterom EN 143), rukavica i zaštitnih naočala.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Croatian: Znanstveni zaključci i razlozi za izmjenu sažetka opisa svojstava, označivanja i uputa o VMP-u
English: The bioavailability of lincomycin may decrease in the presence of gastric antacids or activated charcoal, pectin or kaolin.
Croatian: Bioraspoloživost linkomicina može se smanjiti u prisustvu želučanih antacida ili aktivnog ugljena,
English: farm level) epidemiological information concerning the response of enzootic pneumonia/necrotic enteritis to treatment with lincomycin.
Croatian: na razini farme) epidemiološkim informacijama koje se odnose na odgovor enzootske pneumonije/nekrotičnog enteritisa na liječenje s linkomicinom.
English: Pigs and chickens
Croatian: Svinje i kokoši
English: Pigs: Meat and offal: 1 day.
Croatian: Svinje: Meso i jestive iznutrice: 1 dan.
English: The provided clinical data demonstrated that Lincocin was effective in the treatment and metaphylaxis of necrotic enteritis caused by C. perfringens at a dose rate of 5 mg lincomycin per kg of body weight for 7 consecutive days.
Croatian: Dostavljeni klinički podaci dokazali su da je Lincocin učinkovit u liječenju i metafilaksi nekrotičnog enteritisa prouzročenog bakterijom C. perfringens pri dozi od 5 mg linkomicina po kg tjelesne težine tijekom 7 uzastopnih dana.
English: Enzootic pneumonia: 10 mg lincomycin per kg of body weight (corresponding to 25 mg product per kg bodyweight) for 21 consecutive days.
Croatian: Enzootska pneumonija: 10 mg linkomicina po kg tjelesne mase (što odgovara 25 mg proizvoda po kg tjelesne mase) kroz 21 uzastopni dan.
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.
Croatian: Budući da nema podataka koji bi potkrijepili razdoblje karencije u kokoši nesilica, upotreba lijeka ne smije biti odobrena u peradi čija su jaja namijenjena za konzumaciju.
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.
Croatian: Rezistencija na linkomicin se često prenosi plazmidima nošenim faktorima (erm geni) za kodiranje izmjena mjesta vezanja na ribosomima pomoću metilaze i često dovodi do križne rezistencije na druge antimikrobne tvari iz skupine makrolida, linkozamida i streptogramina.
English: Oral
Croatian: Oralno