FrancophonIA/ELRC3.0 huggingface dataset:
English: The assay results are presented as % of a target value of 552,000 IU/g.
Croatian: Rezultati ispitivanja prikazani su kao postotak ciljane vrijednosti od 552 000 IU/g.
English: Cattle: The use is not intended during pregnancy or lactation.
Croatian: Goveda: Proizvod nije namijenjen za upotrebu tijekom graviditeta ili laktacije.
English: The referral notification was based on concerns related to divergent national decisions having been taken by EU Member States resulting in discrepancies in the product information with respect to e.g. target species, indications for use, posology (dosage and duration) and withdrawal periods.
Croatian: Obavijest o upućivanju temeljila se na zabrinutosti zbog različitih nacionalnih odluka država članica EU-a koje su rezultirale razlikama u informacijama o VMP-u u pogledu, na primjer, ciljanih vrsta, indikacija za primjenu, doziranja (doza i trajanja liječenja) i razdoblja karencije.
English: Aminoglycosides are listed by WHO (2017)14 as critically important for the treatment of certain zoonotic infections in humans (such as Enterococcus infections).
Croatian: Aminoglikozidi su na uvršteni na popis Svjetske zdravstvene organizacije (2017.)14 kao lijekovi od ključne važnosti za liječenje određenih zoonotskih infekcija u ljudi (kao što su infekcije prouzročene bakterijom Enterococcus).
English: The presence of E. coli was demonstrated by previous bacteriological or clinical results and was confirmed in samples taken from rabbits sacrificed or found dead after inclusion.
Croatian: Prisutnost bakterije E. coli dokazana je na osnovi prethodnih bakterioloških ili kliničkih rezultata te je potvrđena u uzorcima uzetima iz kunića koji su žrtvovani ili pronađeni mrtvi nakon uključivanja u ispitivanje.
English: This is also supported by statistical analysis presented by the MAH which demonstrates that there is no change in assay over time.
Croatian: To je ujedno potkrijepljeno statističkom analizom koju je dostavio nositelj odobrenja, koja pokazuje da s vremenom ne dolazi do promjene u ispitivanju.
English: Pigs have been authorised as a target species for all products concerned by this referral procedure, as was the proposed indication, ‘Treatment of bacterial enteritis caused by Escherichia coli susceptible to apramycin.'
Croatian: Svinje su odobrene kao ciljana vrsta za sve proizvode obuhvaćene ovim postupkom upućivanja, kao i za predloženu indikaciju „liječenje bakterijskog enteritisa prouzročenog bakterijom Escherichia coli osjetljivom na apramicin”.
English: de la Industria, nº 30 Polígono Industrial de Alcobendas 28108 Alcobendas (Madrid)
Croatian: 28108 Alcobendas (Madrid)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kartonskoj kutiji nakon EXP.
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, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svojeg veterinara.
English: Even host-adapted serovars (as Salmonella Dublin) might cause disease in humans (Evangelopoulou et al., 20142; Singh, 20133) so the use of antimicrobials in food producing animals should consider the zoonotic role of Salmonella and the consequences for public health (EFSA and ECDC, 20164).
Croatian: Čak bi i serovari prilagođeni domaćinu (kao što je bakterija Salmonella Dublin) mogli prouzročiti bolest u ljudi (Evangelopoulou i dr., 2014.2; Singh, 2013.3) i stoga bi u pogledu primjene antimikrobnih lijekova u životinja namijenjenih za proizvodnju hrane trebalo razmotriti zoonotsku ulogu bakterije Salmonella te posljedice za javno zdravlje (EFSA i ECDC, 2016.4).
English: In this sense, it should be taken into account that the efficacy of the product was supported by various studies, where the veterinary medicinal product was administered for treatment and not for prevention.
Croatian: U tom je pogledu potrebno uzeti u obzir činjenicu da je djelotvornost proizvoda potkrijepljena raznim studijama u okviru kojih se VMP primjenjivao za liječenje, a ne za prevenciju.
English: • Any use of antimicrobials in poultry will increase the risk of emergence and spread of resistance in zoonotic bacteria such as Salmonella spp.
Croatian: • Svaka primjena antimikrobnih lijekova u peradi povećat će rizik od pojave i širenja otpornosti na zoonotske bakterije kao što je Salmonella spp.
English: Avoid contact with the eyes, skin and mucous membranes and inhalation of dust while preparing the medicated water/milk.
Croatian: Izbjegavajte kontakt s očima, kožom i sluznicom te inhalaciju prašine tijekom pripremanja vode/mlijeka koji sadržavaju VMP.
English: With regard to the use of Girolan against Salmonella it was considered that in line with Regulation (EC) No. 1177/200610, antimicrobials should not be used for control and treatment of Salmonella in poultry except in exceptional circumstances.
Croatian: U pogledu primjene VMP-a Girolan protiv bakterije Salmonella smatralo se, u skladu s Uredbom (EZ) br. 1177/200610, da se antimikrobni lijekovi ne bi trebali primjenjivati za kontrolu i liječenje bakterije Salmonella u peradi, osim u iznimnim okolnostima.
English: The oral administration of apramycin is intended for antimicrobial activity within the gut; apramycin is poorly absorbed, but absorption may be increased in young animals and in animals with disrupted intestinal barrier.
Croatian: Oralna primjena apramicina namijenjena je za antimikrobnu aktivnost unutar crijeva; apramicin se slabo apsorbira, ali se apsorpcija može povećati kod mladih životinja i kod životinja s poremećajem u crijevnoj barijeri.
English: In case of eye contact, rinse the affected area with plenty of water.
Croatian: U slučaju kontakta s očima zahvaćeno područje isperite većom količinom vode.
English: The marketing authorisation holder has provided twelve field trials in support of the efficacy for the indication against E. coli.
Croatian: Nositelj odobrenja dostavio je podatke o 12 terenskih ispitivanja kako bi potkrijepio tvrdnje o djelotvornosti za indikaciju protiv bakterije E. coli.
English: Regarding the indication in Salmonella, recent data were provided indicating good susceptibility to apramycin for Salmonella spp., however the only data specific to Salmonella Gallinarum was from Nigeria (Agbaje et al., 20107) and Korea (Kang et al., 20108) and the epidemiological situation in Europe might be different.
Croatian: U pogledu indikacije za bakteriju Salmonella dostavljeni su najnoviji podatci koji pokazuju dobru osjetljivost na apramicin za bakteriju Salmonella spp. Međutim, jedini konkretni podatci za bakteriju Salmonella Gallinarum bili su iz Nigerije (Agbaje i dr., 2010.7) i Koreje (Kang i dr., 2010.8), dok bi epidemiološka situacija u Europi mogla biti drugačija.
English: Moreover, Regulation (EU) No 2016/429 (‘Animal Health Law')12, states that the Member States may take measures concerning the use of veterinary medicinal products for listed diseases to ensure the most efficient prevention or control of those diseases.
Croatian: Štoviše, u Uredbi (EU) br. 2016/429 („Zakon o zdravlju životinja”')12 navodi se da države članice mogu poduzeti mjere u pogledu primjene veterinarsko-medicinskih proizvoda za bolesti s popisa radi jamčenja najdjelotvornije prevencije ili kontrole tih bolesti.
English: The CVMP noted that throughout the product information of Girolan the active substance was expressed as ‘g of apramycin activity'.
Croatian: CVMP je napomenuo da se u informacijama o VMP-u Girolan djelatna tvar izražava kao „g djelovanja apramicina”.
English: • No specific advantages were identified for the use of antimicrobials in the case of meat-producing flocks.
Croatian: • U slučaju jata za proizvodnju mesa nisu utvrđene nikakve posebne prednosti primjene antimikrobnih lijekova.
English: Apramycin resistance can be influenced by co-selection (resistance to apramycin has been described to be located in the same mobile genetic element that other resistant determinants in Enterobacteriaceae) and cross resistance (e. g. with gentamicin).
Croatian: Otpornost na apramicin može biti pod utjecajem koselekcije (otpornost na apramicin u istom je mobilnom genetskom elementu kao druge rezistentne determinante u organizmima Enterobacteriaceae) i križne rezistencije (npr. kod gentamicina).
English: The administration of aminoglycosides to animals suffering from renal impairment or in combination with substances that also affect renal function may therefore present a risk of intoxication.
Croatian: Primjena aminoglikozida kod životinja koje pate od oštećenja bubrega ili u kombinaciji s tvarima koje također utječu na funkciju bubrega može predstavljati rizik od trovanja.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, životinjskih vrsta, puteva primjene, nositelja odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet u državama članicama
English: With regard to the withdrawal period, of all the residue depletion studies provided, only one was considered adequate to be statistically analysed.
Croatian: U pogledu razdoblja karencije, samo se jedna od dostavljenih studija o izlučivanju rezidua smatrala prikladnom za statističku analizu.
English: arizonae Infection in Humans' J. Clin.
Croatian: Humans' J. Clin.
English: Rabbits have been previously authorised in France, Italy and Spain.
Croatian: Primjena na kunićima prethodno je odobrena u Francuskoj, Italiji i Španjolskoj.
English: 'Pork Meat as a Potential Source of Salmonella enterica subsp.
Croatian: 2014. 'Pork Meat as a Potential Source of Salmonella enterica subsp. arizonae Infection in
English: EXPIRY DATE EXP {month/year} Once diluted, use within 24 hours.
Croatian: EXP {mjesec/godina}> Jednom razrijeđen, upotrijebiti unutar 24 sata.
English: Again, no data for Salmonella Gallinarum was presented and in view of this it was not considered further for this indication.
Croatian: Međutim, za bakteriju Salmonella Gallinarum nisu predočeni nikakvi podatci te se u tom pogledu ona više nije razmatrala za tu indikaciju.
English: Do not use in case of hypersensitivity to apramycin.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na apramicin.
English: The CVMP considered that the use of antimicrobials in Salmonella would increase selective pressure and potentially promote antimicrobial resistance dissemination.
Croatian: CVMP je smatrao da bi se primjenom antimikrobnih lijekova za bakteriju Salmonella povećao pritisak u pogledu odabira i potencijalno poticalo širenje antimikrobne otpornosti.
English: Section 6.4 of the agreed SPC for the product states that no specific storage precautions are required for the product.
Croatian: U odjeljku 6.4. usuglašenog sažetka opisa svojstava za VMP navodi se da za taj proizvod nisu potrebne nikakve posebne mjere u pogledu čuvanja.
English: The dosages of apramycin base or apramycin sulfate used were 0, 5.5, 11, 22 and/or 44 mg/kg bw/day during 5 or 10 consecutive days.
Croatian: Primijenjena doza apramicin baze ili apramicin sulfata iznosila je 0, 5,5, 11, 22 i/ili 44 mg/kg tm/dan tijekom 5 ili 10 uzastopnih dana.
English: The marketing authorisation holders' grounds for the re-examination were submitted on 18 December
Croatian: Razlozi nositelja odobrenja za ponovnu procjenu podneseni su 18. prosinca 2017.
English: The objectives were to evaluate the efficacy of apramycin sulfate, administered in the drinking water for five consecutive days, at dose levels of 75, 150 and 225 mg/litre as treatment for these infections.
Croatian: Cilj je bio ocijeniti djelotvornost apramicin sulfata primijenjenog u vodi za piće tijekom pet uzastopnih dana pri dozama od 75, 150 i 225 mg/litra kao terapije za te infekcije.
English: • The use of antimicrobials is never totally effective for the control of Salmonella spp.
Croatian: • Primjena antimikrobnih lijekova nikada nije u cijelosti djelotvorna za kontrolu bakterije
English: X mean body weight (kg) of animals to be treated =
Croatian: X prosječna tjelesna masa (kg) životinja koje će biti liječene =
English: Some strains of Salmonella Typhimurium DT104 in addition to resistance against betalactams, streptomycin, tetracyclines and sulphonamides carry a conjugative resistance plasmid against apramycin.
Croatian: Neki sojevi Salmonella Typhimurium DT104, uz otpornost na beta-laktame, streptomicin, tetracikline i sulfonamide, nose i konjugativne plazmide koji daju rezistenciju na apramicin.
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: These trials were conducted in Greece, Italy, Spain, the United Kingdom, USA and Canada.
Croatian: Ta su ispitivanja provedena u Grčkoj, Italiji, Španjolskoj, Ujedinjenoj Kraljevini, SAD-u i Kanadi.
English: The report states that in developed countries antimicrobials are rarely used in commercial flocks for treatment of Salmonella Pullorum and Salmonella Gallinarum as they do not eliminate the infection from flocks and other control measures such as high level biosecurity, movement restrictions and depopulation are used instead.
Croatian: U izvješću se navodi da se u razvijenim zemljama antimikrobni lijekovi rijetko upotrebljavaju za liječenje bakterija Salmonella Pullorum i Salmonella Gallinarum u komercijalnih jata jer ne otklanjaju infekciju iz jata te da se umjesto njih primjenjuju druge kontrolne mjere kao što su biološka sigurnost visoke razine, ograničenja kretanja i depopulacija.
English: Do not use in laying hens and within 4 weeks before the onset of the laying period.
Croatian: Ne upotrebljavajte kod nesilica ili unutar četiri tjedna prije početka razdoblja nesenja.
English: In the case of calves it can be administered in milk or milk replacer.
Croatian: U slučaju teladi, VMP se može primijeniti u mlijeku ili zamjenskom mlijeku.
English: Additionally, in some Member States a measuring device was authorised for the administration of Girolan.
Croatian: Osim toga, u nekim je državama članicama za primjenu VMP-a Girolan odobren uređaj za mjerenje.
English: Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal.
Croatian: Upotreba veterinarsko-medicinskog lijeka treba se temeljiti na ispitivanju osjetljivosti bakterija izoliranih iz životinje.
English: Apramycin is a broad-spectrum bactericidal aminoglycoside antibiotic whose action results from the binding to the 30S subunit of the ribosome, preventing protein synthesis and disrupting the membrane permeability of bacteria.
Croatian: Apramicin je baktericidni aminoglikozidni antibiotik širokog spektra čije djelovanje proizlazi iz vezanja na 30S podjedinicu ribosoma, sprječavajući sintezu proteina i narušavajući propusnost membrane bakterija.
English: Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programs for the control of salmonella in poultry - link 10 Regulation (EC) No 1177/2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the
Croatian: Regulation (EC) No 1177/2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the
English: 6 Henderson, K. and Mason, C. 2017.
Croatian: Vet Ireland J 4:642-3 6 Henderson, K. and Mason, C. 2017.
English: The marketing authorisation holder provided one field trial including chickens artificially infected with Salmonella Pullorum.
Croatian: Nositelj odobrenja dostavio je jedno terensko ispitivanje kojim su bili obuhvaćeni pilići umjetno zaraženi bakterijom Salmonella Pullorum.
English: Where a diagnosis of Salmonella Dublin is made on the farm, then control measures including on-going monitoring of disease status, vaccination, biosecurity and movement controls should be considered.
Croatian: Kada je Salmonella Dublin dijagnosticirana na farmi, potrebno je razmotriti mjere kontrole koje uključuju kontinuirano praćenje stanja bolesti, cijepljenja i biosigurnosti, a u obzir bi trebalo uzeti i kontrolu kretanja.
English: Apramycin has been shown to be efficacious in the treatment of Salmonella infections in calves where its use reduced mortality and may therefore be justified on animal welfare grounds.
Croatian: Apramicin se pokazao djelotvornim u liječenju infekcija bakterijom Salmonella u teladi, pri čemu se njegovom primjenom smanjila smrtnost i stoga se primjena apramicina može opravdati na osnovi dobrobiti životinja.
English: Abt. Elanco Animal Health
Croatian: Elanco Animal Health
English: PACKAGE SIZE 50 x 106 IU (bottle) 1,000 x 10
Croatian: 50 x 106 IU (boca) 1000 x 106 IU (vreća)
English: Apramycin is effective against Gram-negative bacteria (Salmonella and Escherichia coli).
Croatian: Apramicin je učinkovit protiv gram-negativnih bakterija (Salmonella i Escherichia coli).
English: Moreover, Regulation (EU) No 2016/429 (‘Animal Health Law')12, that lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans, in Article 46 it is stated that the Member States may take measures concerning the use of veterinary medicinal products for listed diseases to ensure the most efficient prevention or control of those diseases, provided that such measures are appropriate or necessary.
Croatian: Uredbe (EU) br. 2016/429 („Zakon o zdravlju životinja”)12, kojom se utvrđuju pravila za prevenciju i kontrolu bolesti životinja koje su prenosive na životinje ili ljude, navodi se da države članice mogu poduzeti mjere u pogledu primjene veterinarsko-medicinskih proizvoda za bolesti s popisa kako bi se zajamčila najdjelotvornija prevencija ili kontrola tih bolesti, pod uvjetom da su takve mjere primjerene ili potrebne.
English: In this respect, it was considered necessary to add the following sentence in section 4.5 of the summary of product characteristics (SPC) ‘Special precautions for use in animals': ‘Where a diagnosis of Salmonella Dublin is made on the farm, then control measures including on-going monitoring of disease status, vaccination, biosecurity and movement controls should be considered.
Croatian: U tom se pogledu smatralo da je u odjeljak 4.5. sažetka opisa svojstava VMP-a „Posebne mjere opreza prilikom primjene na životinjama” potrebno dodati sljedeću rečenicu: „Ako je na stočarskom gospodarstvu dijagnosticirana infekcija bakterijom Salmonella Dublin, potrebno je razmotriti kontrolne mjere, uključujući stalno praćenje stanja bolesti, cijepljenje, biološku sigurnost i kontrole kretanja.
English: Amounts to be administered:
Croatian: Količine koje se primjenjuju:
English: The data provided also indicated that resistance to apramycin is not very common among E. coli isolates of cattle origin.
Croatian: Dostavljeni podatci pokazali su i da otpornost na apramicin nije vrlo česta među izolatima bakterije E. coli koja potječe od goveda.
English: • If antimicrobials are used in breeding flocks or their immediate descendants there is a risk that any resistant bacteria which are selected may be disseminated to multiple flocks via contamination of hatching eggs and the hatchery environment.
Croatian: • Kada se antimikrobni lijekovi primjenjuju u rasplodnih jata ili u njihovih izravnih potomaka, postoji rizik da bi se svaka otporna odabrana bakterija mogla proširiti na više jata kontaminacijom jaja za nasad i mjesta za izlijeganje.
English: Apramycin ……………………………552,000 IU* (as apramycin sulfate) * IU - international units
Croatian: Djelatnu tvar: apramicin ……………………………552 000 IU* (u obliku apramicin-sulfata).
English: The referral leads to full harmonisation of the product information.
Croatian: Upućivanje rezultira potpunom usklađenošću informacija o VMP-u.
English: DK-2730 Herlev Denmark
Croatian: Lyskær 3E, 2 tv. DK-2730 Herlev Denmark
English: The data provided also indicated that resistance to apramycin is increasing among E. coli isolates of pig origin, so the wording ‘susceptible to apramycin' was added to the indication.
Croatian: Dostavljeni podatci pokazali su i da se otpornost na apramicin među izolatima bakterije E. coli koji potječu od svinja povećava te je stoga u indikaciju dodan tekst „osjetljiva na apramicin”.
English: In various European monitoring programs, E. coli isolate from chickens were susceptible to apramycin.
Croatian: U raznim europskim programima praćenja ustanovljeno je da je izolat bakterije E. coli iz pilića bio osjetljiv na apramicin.
English: Treatment resulted in an almost linear dose/response in percent survival for apramycin dosages up to 22 mg/kg bw.
Croatian: Ishod liječenja pokazao je gotovo linearan odnos doze i odgovora u postotku preživljavanja za doze apramicina do 22 mg/kg tm.
English: 1 g powder contains 500 mg apramycin as apramycin sulfate in 2.2 ml equivalent to 1 g powder
Croatian: 1 g praška sadržava 500 mg apramicina u obliku apramicinsulfata u 2,2 ml ekvivalentno 1 g praška
English: These studies involved one to three days old calves experimentally challenged with either Salmonella Dublin or Salmonella typhimurium, the most frequent serovars of Salmonella spp.
Croatian: Tim je ispitivanjima bila obuhvaćena telad u dobi od jednog do tri dana na kojoj su provedeni pokusi s bakterijom Salmonella Dublin ili s bakterijom Salmonella typhimurium, najčešćim serovarima bakterije Salmonella spp. u goveda.
English: Apramycin was shown to be effective as measured by increased weight gain, improved feed efficiency, reduction of mortality rate, and the reduction in severity of diarrhoea and clinical signs.
Croatian: Apramicin se pokazao djelotvornim prema sljedećim mjerilima: povećanje tjelesne mase, bolja učinkovitost ishrane, smanjenje stope smrtnosti i smanjenje ozbiljnih oblika proljeva i kliničkih znakova.
English: In case of onset of symptoms after exposure such as skin rash, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju pojave simptoma nakon izlaganja, poput osipa na koži, odmah potražite pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
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 subject to the recommended changes in the product information.
Croatian: Nakon razmatranja razloga za postupak upućivanja i podataka koje je dostavio nositelj odobrenja, CVMP je zaključio da omjer koristi i rizika ostaje pozitivan uz predložene promjene informacija o VMP-u.
English: No data were presented for Salmonella Pullorum.
Croatian: Za bakteriju Salmonella Pullorum nisu dostavljeni nikakvi podatci.
English: Based on historical batch data, a target potency of 552,000 IU/g apramycin was established and all references to ‘g of apramycin activity' in the product information were replaced with the equivalent in IU/g product.
Croatian: Na temelju skupa povijesnih podataka utvrđena je ciljana jačina za apramicin koja iznosi 552 000 IU/g te su sva upućivanja na „g djelovanja apramicina” u informacijama o VMP-u zamijenjena ekvivalentima izraženima u IU/g proizvoda.
English: With regard to the withdrawal period, the residue depletion data indicated that apramycin is generally not well-absorbed from the gut after oral administration, which is consistent with the information available in published literature.
Croatian: U pogledu razdoblja karencije, podatci o izlučivanju rezidua pokazali su da se apramicin uglavnom ne apsorbira dobro iz crijeva nakon oralne primjene, što je u skladu s informacijama koje su dostupne u objavljenoj literaturi.