FrancophonIA/ELRC3.0 huggingface dataset:
English: Intramuscular administration of enrofloxacin showed to be effective especially in cases of enterotoxaemia.
Croatian: Intramuskularna primjena enrofloksacina pokazala se učinkovitom, posebice u slučajevima enterotoksemije.
English: The critical PK parameters in milk were determined following intravenous administration of the 100 mg/ml strength and used to calculate the predictive PK/PD ratios together with MIC90 values for E. coli.
Croatian: Kritični FK parametri u mlijeku utvrđeni su nakon intravenozne primjene doze jačine od 100 mg/ml i koristili su se za izračun predviđenih FK/FD omjera zajedno s MIC90 vrijednostima za E. coli.
English: From the overall data provided by the MAHs (efficacy data, PK/PD and target pathogens resistance), it can be concluded that the dose of 2.5 mg/kg bw/day (even showing a relatively good clinical response in some cases) may not allow complete elimination of bacteria and it could lead to resistance development against E. coli.
Croatian: Iz cjelokupnih podataka koje je dostavio nositelj odobrenja (podaci o djelotvornosti, FK/FD podaci i rezistencija ciljnih patogena), može se zaključiti da doza od 2,5 mg/kg tjelesne težine/dan (koja pokazuje čak i relativno dobar klinički odgovor u pojedinim slučajevima) ne mora u potpunosti eliminirati bakteriju, te može rezultirati razvojem rezistencije na E. coli.
English: From the results obtained, it was not possible to confirm whether the lower dose (2.5 mg/kg bw) produced cure or improvement in the animals.
Croatian: Na temelju zaprimljenih rezultata nije bilo moguće potvrditi je li slabija doza (2.5 mg/kg tjelesne težine) rezultirala izlječenjem ili poboljšanjem u životinja.
English: Cattle (intravenous)
Croatian: Goveda (intravenozno)
English: The high efficacy of enrofloxacin in the MMA-syndrome therapy has been confirmed by meta-analysis and systematic review of 6 clinical and susceptibility studies on MMA/PDS and enrofloxacin from the period 1990 to 1998.
Croatian: Visoka razina djelotvornosti enrofloksacina u terapiji sindroma MMA potvrđena je meta analizom i sistemskim pregledom 6 kliničkih ispitivanja i ispitivanja osjetljivosti na sindrom MMA/PDS i enrofloksacin u razdoblju od 1990. do 1998.
English: Add, to all products:
Croatian: Dodati za sve lijekove:
English: The results from the pharmacokinetic/pharmacodynamic (PK/PD) analysis with M. haemolytica were not fully predictive of clinical efficacy.
Croatian: farmakodinamičke (FK/FD) analize provedene s M. haemolytica nisu u potpunosti pretpostavljali kliničku djelotvornost.
English: The CVMP position paper regarding availability of products for minor uses and minor species (EMEA/CVMP/477/03)1 establishes that cattle (dairy and meat animals) and sheep (meat animals) are considered as major food-producing species.
Croatian: Dokumentom o stavu CVMP-a u vezi s dostupnošću proizvoda za manju uporabu i manje vrste (EMEA/CVMP/477/03)1 utvrđeno je da se goveda (životinje za proizvodnju mlijeka i mesa) i ovce (životinje za proizvodnju mesa) smatraju većim vrstama za proizvodnju hrane.
English: In another study after five months at the end of the study, no enrofloxacin resistant bacteria could be isolated from the treated sows.
Croatian: U drugom ispitivanju nakon pet mjeseci na kraju ispitivanja nisu mogle biti izolirane bakterije otporne na enrofloksacin iz liječenih krmača.
English: 2065m 06516 Carros Cedex France
Croatian: 2065m 06516 Carros Cedex Francuska
English: The withdrawal periods should be amended as proposed to provide assurance for consumer safety.
Croatian: Razdoblja karencije treba izmijeniti u skladu s prijedlozima kako bi se osigurala sigurnost potrošača.
English: Agnoletti et al. First reporting of methicillin-resistant Staphylococcus aureus (MRSA) ST398 in an industrial rabbit holding and in farm-related people.
Croatian: First reporting of methicillin-resistant Staphylococcus aureus (MRSA) ST398 in an industrial rabbit holding and in farm-related people.
English: Although horses are not authorised as target species the Committee considered that a contraindication for use in growing horses should be included in the product information for the 50 mg/ml and 100 mg/ml strengths.
Croatian: Iako konji nisu odobrena ciljna vrsta, Odbor smatra da u informacije o proizvodu treba uvrstiti kontraindikaciju za jačine od 50 mg/ml i 100 mg/ml.
English: The efficacy against M. haemolytica and Mycoplasma bovis has been justified with several experimental studies in which induced infection with M. haemolytica and M. bovis was produced.
Croatian: Djelotvornost protiv M. haemolytica i Mycoplasma bovis opravdana je s nekoliko eksperimentalnih ispitivanja, u kojima su proizvedene inducirane infekcije patogenima M. haemolytica i M. bovis.
English: However, several experimental controlled studies were conducted employing both 2.5 and 5 mg/kg body weight (bw) parenteral doses, but more consistent data on the higher dose were presented.
Croatian: Provedeno je nekoliko eksperimentalnih kontroliranih ispitivanja u kojima su korištene obje parenteralne doze od 2,5 i 5 mg/kg tjelesne težine, no dostavljeni su konzistentniji podaci o većim dozama.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, životinjskih vrsta, putova primjene i nositelja odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet u državama članicama
English: Germany Medistar Arzneimittel-Vertrieb GmbH
Croatian: Njemačka Medistar Arzneimittel-Vertrieb GmbH
English: The results showed that all groups of medicated piglets increased in weight thus contrasting the control animals that were not treated with enrofloxacin.
Croatian: Rezultati su pokazali da je u svim grupama praščića došlo do povećanja u težini te su stoga predstavljali razliku u odnosu na kontrolne životinje koje nisu bile tretirane enrofloksacinom.
English: In addition, a PK/PD analysis was conducted with this pathogen, obtaining values considered as predictive of clinical efficacy.
Croatian: Nadalje, provedene su FK/FD analize s ovim patogenom, a zaključeno je da su dobivene vrijednosti predvidive za kliničku djelotvornost.
English: The PK/PD analysis shows that the PK/PD ratios are largely exceeded for Gram-negative pathogens.
Croatian: FK/FD analiza pokazuje da je omjer FK/FD uvelike premašen za gram-negativne patogene.
English: Via G. Puecher, 8
Croatian: Puecher, 8
English: In both studies the first time point at which residues in milk from all animals were below the MRL was 72 hours.
Croatian: U oba ispitivanja prva vremenska točka u kojoj su rezidui u mlijeku iz svih životinja bili niži od MRL-a iznosila je 72 sata.
English: A multi-centric comparative field trial in sows has been provided.
Croatian: Dostavljeno je multicentrično komparativno ispitivanje u krmača.
English: All residues were below the MRL on the 4th milking (48 hours).
Croatian: Svi rezidui bili su niži od MRL-a 4. dana mužnje (48 sati).
English: aureus strains were isolated from commercial rabbit farms in different Member States and tested for resistance.
Croatian: - u drugom ispitivanju, 56 sojeva Staph. aureus bilo je izolirano s komercijalnih farma zečeva u različitim državama članicama i testirano na rezistenciju.
English: Germany Calluna Pharma bvba Treslong 34
Croatian: Njemačka Calluna Pharma bvba Treslong 34
English: However, there are concerns regarding the moderate to high resistance rates observed in enteric E. coli isolated from cattle and pigs.
Croatian: No, postoje zabrinutosti u vezi s umjerenim stopama rezistencije uočenima u crijevnoj E. coli izoliranoj iz stoke i svinja.
English: Where the following target species have already been approved, the following withdrawal periods apply:
Croatian: Ako već postoji odobrenje za ciljne životinjske vrste navedene u nastavku, primjenjuju se sljedeća razdoblja karencije:
English: Enrofloxacin showed better clinical results than oxytetracyclin at all dose levels, with a more rapid decrease of total clinical scores and faecal consistency scores.
Croatian: Enrofloksacin je pokazao bolje kliničke rezultate od rezultata dobivenih oksitetraciklinom na svim razinama, s bržim smanjivanjem ukupnih kliničkih rezultata i rezultata fekalne konzistencije.
English: A second dose-titration trial was conducted in Japan with natural infection caused by E. coli in suckling piglets.
Croatian: Ispitivanje titranja druge doze provedeno je u Japanu s prirodnom infekcijom koju uzrokuje E. coli u praščića koji sisaju.
English: In order to optimise the dosage and to avoid development of resistance it has been concluded that the dose rate of 2.5 mg/kg bw/day should be deleted for all the indications in cattle.
Croatian: Kako bi se optimiziralo doziranje i s ciljem izbjegavanja razvoja rezistencije, može se zaključiti da se doza od 2,5 mg/kg tjelesne težine/dan treba izbrisati za sve indikacije u goveda.
English: However, at the lower dose, residues were above the MRLs at day 1 but below the MRLs by the second time point (day 4 after administration).
Croatian: No, u slučaju manjih doza, rezidui su bili veći od MRL-ova u 1. danu, no manji od MRL-ova do druge vremenske točke (4. dana nakon primjene).
English: Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins.
Croatian: Zabilježeno je da rezistencija na fluorokinolone može nastati na pet načina: (i) točkaste mutacije u genima koji kodiraju DNK-girazu i/ili topoizomerazu IV, a što dovodi do promjena navedenih enzima, (ii) promjene propusnosti stjenke gram-negativnih bakterija za lijek, (iii) mehanizmi efluksa, (iv) plazmidima posredovana rezistencija i (v) zaštitni proteini giraze.
English: The study was conducted with only 12 animals and therefore a statistical analysis8 of the data could not be performed and consequently a withdrawal period was derived using the alternative approach.
Croatian: Ispitivanje je provedeno na samo 12 životinja, te stoga nije bilo moguće provesti statističku analizu8 podataka te je posljedično izvedeno razdoblje karencije primjenom alternativnog pristupa.
English: Milk (50 mg/ml and 100 mg/ml strengths): As the relevant products will not leave local residues in milk, the withdrawal period established for the major species can be directly extrapolated to the minor species without the need to apply a safety span.
Croatian: Mlijeko (jačine 50 mg/ml i 100 mg/ml): Budući da relevantni proizvodi neće ostaviti lokalne rezidue u mlijeku, karencija utvrđena za veće vrste može se izravno ekstrapolirati na manje vrste bez potrebe primjene sigurnosnog raspona.
English: It is therefore appropriate to derive a single harmonised withdrawal period based on the totality of residue data from all formulation groups.
Croatian: Stoga je primjereno izvesti jedinstveno usklađeno razdoblje karencije na temelju ukupnosti podataka o reziduima iz svih grupa formulacije.
English: Target species, indications and posology
Croatian: Ciljne vrste, indikacije i doziranje
English: Laboratorios Dr. Esteve, S.A. Avda.
Croatian: Španjolska Laboratorios Dr. Esteve, S.A. Avda.
English: Litvínovská 609/3 190 21 Praha 9
Croatian: 190 21 Praha 9
English: An enrofloxacin intramuscular injection at 2.5 mg/kg bw, administered once daily until the clinical signs of respiratory disease decreased, resulted in a 94.5% success rate.
Croatian: Intramuskularna injekcija enrofloksacina jačine od 2,5 mg/kg tjelesne težine, primijenjena je jednom dnevno sve dok se klinički znakovi respiratorne bolesti nisu smanjili, što je rezultiralo stopom uspješnosti od 94,5%.
English: The data show that, in general, high susceptibility to enrofloxacin is observed among the majority of strains of bovine and porcine respiratory pathogens as well as non-enteric E. coli.
Croatian: Podaci pokazuju da je općenito visoka razina osjetljivosti na enrofloksacin uočena u većini sojeva goveđih i svinjskih respiratornih patogena kao i u necrijevne E. coli.
English: In the field study, calves (from 15 kg to 150 kg bw) with naturally occurring gastrointestinal infections due to E.coli, were treated every day with enrofloxacin either orally, by a parenteral (intramuscular, subcutaneous or intravenous) route followed by oral, or only parenteral route.
Croatian: U terenskom ispitivanju, telad (od 15 kg do 150 kg tjelesne težine) s prirodnom pojavom gastrointestinalnih infekcija uslijed E.coli, tretirana su svaki dan enrofloksacinom bilo oralno ili parenteralno (intramuskularno, supkutano ili intravenozno) nakon čega je slijedio oralni, ili samo parenteralni način primjene.
English: In these studies different doses were administered (overall range 1-6 mg/kg bw/day) and the study design did not allow evaluating the efficacy of each dose individually.
Croatian: U tim su ispitivanjima primijenjene različite doze (cjelokupni raspon od 1 do 6 mg/kg tjelesne težine/dan), a način ispitivanja nije omogućio ocjenu djelotvornosti svake doze posebno.
English: aureus in rabbits, no other veterinary medicinal products are authorised for this indication in this animal species in the EU.
Croatian: U slučajevima dermatitisa kojeg uzrokuje Staph. aureus u zečeva, drugi veterinarsko-medicinski proizvodi nisu odobreni za ovu indikaciju za te životinjske vrste u EU-u.
English: Belgium Vandenbussche Farma Service Brusselsesteenweg 396
Croatian: Vandenbussche Farma Service Brusselsesteenweg 396 1980 Eppegem
English: Luxembourg Bayer SA-NV J.E.
Croatian: Luksemburg Bayer SA-NV J.E.
English: Sheep and goats
Croatian: Ovce i koze
English: Cattle, pigs weighing more than 25 kg
Croatian: Goveda, svinje teže od 25 kg
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Croatian: Enrofloksacin je sintetska kemoterapijska tvar iz klase derivata fluorkinolon-karboksilne kiseline.
English: Duration of treatment should be based on the duration of treatment approved for the appropriate indication in the SPC of the tablet product.
Croatian: Trajanje liječenja trebalo bi temeljiti na odobrenom trajanju liječenja za indikaciju navedenu u uputi za tablete.
English: Ornamental birds
Croatian: Ukrasne ptice
English: Taking into account all the documentation provided, the CVMP considered that this indication can be accepted, but in the 50 mg/ml strength it should be stated as “Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of
Croatian: Uzimajući u obzir cjelokupnu dostavljenu dokumentaciju, CVMP smatra da se ova indikacija može prihvatiti, no u jačini od 50 mg/ml mora biti navedeno „Liječenje akutnog artritisa povezanog s mikoplazmom zbog sojeva patogena Mycoplasma bovis podložnih enrofloksacinu”.
English: The efficacy of enrofloxacin for the treatment of acute mastitis was investigated in a field trial in sheep with clinical signs of acute mastitis.
Croatian: Djelotvornost enrofloksacina za liječenje akutnog mastitisa istražena je u terenskom ispitivanju u ovaca s kritičnim znakovima akutnog mastitisa.
English: • on the basis of the available data, the CVMP considered that the dose rate of 2.5 mg/kg bw/day should be deleted for alimentary tract infections and septicaemia due to E. coli in pigs;
Croatian: • je na temelju dostupnih podataka CVMP zaključio da dozu od 2,5 mg/kg tjelesne težine/dan treba obrisati za infekcije probavnog trakta i septikemiju zbog E. coli u svinja;
English: Following intravenous injection:
Croatian: Nakon primjene u venu:
English: Bielawa Poland
Croatian: Bielawa Poljska
English: Enrofloxacin is for veterinary use only.
Croatian: Enrofloksacin je predviđen samo za veterinarsku primjenu.
English: Where the following target species have already been approved, the wording below relating to the relevant species should be used:
Croatian: Ako već postoji odobrenje za ciljne životinjske vrste navedene u nastavku, za pojedine vrste koriste se sljedeće formulacije:
English: Documentation that describes the uses of the injectable veterinary medicinal product in the treatment of infections of both the alimentary and respiratory tract, as well as for the treatment of skin and wound infections was provided.
Croatian: Dostavljena je dokumentacija koja opisuje primjenu injektibilnog veterinarsko-medicinskog proizvoda u liječenju infekcija probavnog i respiratornog trakta, kao i za liječenje kožnih infekcija i infekcija rana.
English: Two field studies were provided to demonstrate the efficacy of enrofloxacin in the treatment of infections of the alimentary tract caused by E.coli and septicaemia caused by E.coli.
Croatian: Dostavljena su dva terenska ispitivanja kako bi se dokazala djelotvornost enrofloksacina u liječenju infekcija probavnog trakta koje uzrokuje E.coli i septikemije koju uzrokuje E.coli.
English: Lublin Poland
Croatian: Lublin Poljska
English: Replication forks and translational complexes cannot proceed beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and mRNA synthesis triggers events resulting in a rapid, drug concentration-dependent killing of pathogenic bacteria.
Croatian: Replikacijske rašlje i translacijski kompleksi ne mogu se nastaviti uslijed stvaranja kompleksa enzim-DNK-fluorokinolon, te je inhibicija sinteze DNK i mRNK je okidač koji dovodi do brzog i o koncentraciji ovisnog uništavanja patogenih bakterija.
English: no particular conclusion could be drawn from the documentation provided, in view of the lack of precise microbiological data (not allowing to assess the efficacy of the product against each of the isolated microorganisms specifically) or the lack of complete elimination of M. hyopneumoniae.
Croatian: Slično tome, i u slučaju patogena Mycoplasma spp. nisu mogli biti donijeti nikakvi posebni zaključci na temelju dostavljene dokumentacije u pogledu nedostatka preciznih mikrobioloških podataka (čime se ne dozvoljava međusobna procjena djelotvornosti proizvoda u odnosu na svaki izolat izoliranih mikroorganizama posebice) ili manjak potpune eliminacije patogena M. hyopneumoniae.
English: In order to compensate for the biological uncertainties and the variability of the data, a safety span of 30% was used, resulting in a withdrawal period of 12 days.
Croatian: Kako bi se kompenzirale biološke nesigurnosti i dostupnost podataka, primijenjen je sigurnosni raspon od 30%, što rezultira karencijom od 12 dana.
English: Therefore for the justification of the posology, a PK/PD were taken into account.
Croatian: Stoga je za potrebe opravdanja doziranja u obzir uzet FK/FD.
English: Regarding the indication for treatment of skin and wound infections caused by Staphylococcus aureus, the available data were suggestive of a non-complete bacteriological cure, and no PK/PD data were available.
Croatian: Vezano uz indikaciju za liječenje kožnih infekcija i infekcija rana koje uzrokuje Staphylococcus aureus, dostupni podaci su sugestivni za nepotpuno bakteriološko liječenje, te nema dostupnih FK/FD podataka.
English: The results of different field studies in piglets with enteritis were summarised.
Croatian: Sažeti su rezultati različitih terenskih ispitivanja u praščića s enteritisom.
English: This withdrawal period should be applied to all the concerned products.
Croatian: Ovo razdoblje karencije treba primijeniti na sve predmetne proizvode.
English: Puławy Poland
Croatian: Puławy Poljska
English: PK/PD and antimicrobial resistance data have been taken into account to justify this indication.
Croatian: FK/FD podaci i podaci o antimikrobnoj rezistenciji uzeti su u obzir kako bi se opravdala ova indikacija.
English: Injectable enrofloxacin decreased diarrhoea incidence up to 70% in suckling piglets.
Croatian: Injektibilan enrofloksacin smanjio je incidenciju proljeva do 70% u praščića koji sisaju.
English: On the other hand, no resistance or very low resistance rates were observed for bacteria causing mastitis in ruminants (E. coli, Staph.
Croatian: S druge strane, rezistencija nije uočena ili su uočene vrlo niske razine rezistencije za bakterije koje uzrokuju mastitis u glodavaca (E. coli, Staph. aureus, koagulas-negativni stafilokoki).
English: Thus, in dogs, the co-administration of enrofloxacin and flunixin increased the AUC and the elimination half-life of flunixin and increased the elimination half-life and reduced the Cmax of enrofloxacin.
Croatian: Stoga je u pasa istovremena primjena enrofloksacina i fluniksina povećala AUC i vrijeme polueliminacije fluniksina te je povećala vrijeme polueliminacije enrofloksacina, a umanjila njegovu vršnu koncentraciju (Cmax).
English: aureus) was 39.5% in the 2.5 mg/kg group and 82% in the 5 mg/kg group.
Croatian: Postotak bakteriološkog lijeka (Staph. aureus) iznosio je 39,5% u grupi koja je primila 2,5 mg/kg, te 82% u grupi koja je primila 5 mg/kg.
English: Supporting literature for use of enrofloxacin was provided in rodents (e.g. hamsters, gerbils, guinea pigs), in reptiles (snakes, lizards and chelonia) and in ornamental birds.
Croatian: Dostavljena je literatura u prilog primjene enrofloksacina za glodavce (primjerice hrčke, skakače, zamorce), u reptila (zmija, guštera i kornjača), te u ukrasnih ptica.
English: Romikim Farma SL Gran Via Carlos III, 98,6 8027 Barcelona Spain
Croatian: Nizozemska Romikim Farma SL Gran Via Carlos III, 98,6
English: S/vet_referral_000067.jsp&mid=WC0b01ac05805c5170 4 Ortega et al. Characterisation and public health risks of antimicrobial resistance in Staphylococcus aureus in intensive rabbit breeding.
Croatian: S/vet_referral_000067.jsp&mid=WC0b01ac05805c5170 4 Ortega et al.
English: Only few data have been submitted by the MAHs regarding resistance in food borne bacteria.
Croatian: Nositelji odobrenja dostavili su samo ograničene podatke u vezi s rezistencijom na bakterije koje se prenose hranom.
English: Meat and offal (50 mg/ml and 100 mg/ml strengths): In line with the CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)9, in relation to identical products the withdrawal period established for a major ruminant species may be extrapolated to a minor ruminant species applying a safety span of 1.5 where there is the potential for local residues.
Croatian: Meso i iznutrice (jačine 50 mg/ml i 100 mg/ml): U skladu sa smjernicama CVMP-a o zahtjevima za podatke o sigurnoj primjeni i reziduima za veterinarsko-medicinske proizvode predviđene za manju uporabu ili manje vrste (EMEA/CVMP/SWP/66781/2005)9 u vezi s identičnim proizvodima, karencija utvrđena za veće vrste preživača može se ekstrapolirati na manje vrste preživača uz primjenu sigurnosnog raspona od 1,5 u slučaju kada postoji potencijal za lokalne rezidue.
English: Intestinal bacterial counts were significantly reduced by treatment with 2.5 mg/kg bw/day.
Croatian: Broj crijevnih bakterija značajno se smanjio terapijom s dozom od 2.5 mg/kg tjelesne težine/dan.
English: The decrease in drug clearances as a result of co-administration of flunixin and enrofloxacin indicates that these substances interact during the elimination phase.
Croatian: Smanjenje klirensa kao posljedica istodobne primjene fluniksina i enrofloksacina ukazuje na njihovu interakciju u fazi eliminacije.
English: Dogs, cats, exotic animals
Croatian: Psi, mačke, egzotične životinje
English: Enrofloxacin is reported to have deleterious effect on articular cartilage in growing horses.
Croatian: Prijavljeno je da enrofloksacin ima štetno djelovanje na zglobnu hrskavicu u konja u razvoju.
English: PFO "Vetos-Farma" Sp. z o.o.
Croatian: PFO "Vetos-Farma" Sp. z o.o. 21 Dzierżoniowska Str.
English: Different tolerance studies were conducted in calves with oral administration of enrofloxacin.
Croatian: U teladi su provedena različita ispitivanja tolerancije s oralnom primjenom enrofloksacina.
English: Treatment with enrofloxacin significantly reduced the incidence and severity of diarrhoea.
Croatian: Liječenje enrofloksacinom značajno je smanjilo incidenciju i ozbiljnost proljeva.