FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the veterinarian must be aware of the correct temperature requirements of the respective reptile species and the hydration status of the individual patient.
Croatian: Stoga veterinar mora biti upoznat s pravilnim temperaturnim zahtjevima dotične vrste gmaza i hidratacijskim statusom pojedinog pacijenta.
English: Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
Croatian: Principala nr. 944 Filipestii de Padure Jud.
English: 21 Montee De La Garde 69340 Francheville France
Croatian: Francuska BIOLIS 21 Montee De La Garde 69340 Francheville Francuska
English: Thus, the indications in farm rabbits should be considered as an extrapolation from other data (oral route for farm rabbits and/or pet rabbits with the injectable route).
Croatian: Stoga indikacije u zečeva na farmama treba uzeti u obzir kao ekstrapolaciju drugih podataka (oralni put u zečeva s farma i/ili zečeva koji su kućni ljubimci s injektibilnim putem).
English: 05-651 Drwalew Poland
Croatian: 05-651 Drwalew Poljska
English: A 20% safety span was considered appropriate to compensate for the small number of animals used in the study.
Croatian: Sigurnosni raspon od 20% smatran je primjerenim za kompenziranje malog broja životinja korištenih u ispitivanju.
English: It is expected that the use of these products for this indication may not be high, as the product is to be administered parenterally to rabbits with a frequency of daily injection for a period of 5 to 10 days.
Croatian: Očekuje se da primjena tih proizvoda za ovu indikaciju neće biti česta, budući da se proizvod primjenjuje parenteralno u zečeva s učestalošću dnevne injekcije tijekom razdoblja od 5 do 10 dana.
English: In pigs, the injection should be made in the neck at the ear base.
Croatian: U svinja, injekcija se daje u vrat uz bazu uha.
English: In view of the lack of therapeutic alternatives, if this indication was not accepted, this product as well as many other antimicrobial products, could be used off-label (under the so-called cascade).
Croatian: U svjetlu nedostatka terapijskih alternativa, te za slučaj neprihvaćanja ove indikacije, ovaj proizvod kao i većina drugih antimikrobika mogli bi se koristiti mimo uputa (primjenom „kaskade“).
English: D-88326 Aulendorf Germany
Croatian: D-88326 Aulendorf Njemačka
English: LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
Croatian: Rumunjska LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
English: It is not clear whether quinolone resistant Campylobacter infection is associated with adverse human health consequences.
Croatian: Nije jasno je li infekcija Campylobacter otporna na kinolon povezana s neželjenim posljedicama po ljudsko zdravlje.
English: Moreover, the excessive volume of injection needed with the 50 mg/ml strength could lead to violation of allowed residues.
Croatian: Nadalje, prekomjeran volumen injekcije potreban za jačinu od 50 mg/ml može rezultirati povredom dozvoljenih razina rezidua.
English: Non-inferiority of the test product was demonstrated.
Croatian: Nije dokazana inferiornost u odnosu na testni proizvod.
English: Warning sentences have been included in sections 4.5 and 4.6 of the SPC regarding the potential articular cartilage damage in growing cattle and lambs, based on the available literature.
Croatian: Rečenice koje sadrže upozorenja uključene su u dijelove 4.5. i 4.6. SPC-a u vezi s potencijalnim oštećenjem zglobne hrskavice u stoke i janjadi u razvoju, na temelju dostupne literature.
English: The results of these trials demonstrated good clinical evolution of animals at the tested doses, but microbiological results were not provided or they indicated an incomplete elimination of the pathogen.
Croatian: Rezultati ovih ispitivanja pokazuju dobru kliničku evoluciju životinja u testiranim dozama, no mikrobiološki rezultati nisu dostavljeni ili ukazuju na nepotpunu eliminaciju patogena.
English: Antimicrobial resistance in target pathogens
Croatian: Antimikrobna rezistencija u ciljnih patogena
English: Prahova Romania
Croatian: Prahova Rumunjska
English: The results of the studies provided show that the variation in the residue profile due to sources of variation associated with the injectable use of these products (e.g. sampling procedure) was much higher than the variation due to formulation effect.
Croatian: Dostavljeni rezultati ispitivanja dokazuju da je razlika u profilu rezidua uslijed izvora varijacija povezanih s injektibilnom primjenom ovih proizvoda (primjerice postupkom uzorkovanja) bila mnogo veća nego varijacija uslijed djelovanja formulacije.
English: Germany Albrecht GmbH Hauptstr.
Croatian: Njemačka Albrecht GmbH Hauptstr.
English: Milk: 3 days.
Croatian: Mlijeko: 3 dana.
English: The 2012 RESAPATH annual report indicated that more than 90% of Pasteurella in goats are sensitive to enrofloxacin.
Croatian: Godišnje izvješće RESAPATH za 2012. godinu ukazao je da je više od 90% Pasteurella u koza bilo osjetljivo na enrofloksacin.
English: The provided data on efficacy are adequate to demonstrate efficacy against this bacteria.
Croatian: Podaci dostavljeni o djelotvornosti su primjereni i dokazuju učinkovitost protiv ove bakterije.
English: Off-label use, leaves the decision on the posology of use to the veterinary practitioner and bears a potential risk of misuse, thus it could increase the risk for developing antimicrobial resistance.
Croatian: Uporaba mimo uputa ostavlja donošenje odluke o doziranju veterinaru i predstavlja potencijalan rizik od zlouporabe, te bi stoga mogla povećati rizik od razvoja antimikrobne rezistencije.
English: Cure or improvement was observed in 85% to 90% of animals treated by enrofloxacin, the best results being obtained when parenteral administration is followed by oral administration.
Croatian: Izlječenje ili poboljšanje uočeno je u 85% do 90% životinja tretiranih enrofloksacinom, pri čemu su najbolji rezultati dobiveni u slučaju kada je nakon parenteralne primjene uslijedila oralna primjena.
English: The respiratory indications were extrapolated from the ones existing in cattle.
Croatian: Respiratorne indikacije za goveda su ekstrapolirane iz postojećih indikacija.
English: The overall benefit-risk balance of the products under this procedure was deemed positive subject to the recommended changes in the product information (see Annex III).
Croatian: Cjelokupan omjer koristi i rizika proizvoda obuhvaćenih ovim postupkom smatra se pozitivnim, i predmetom je preporučenih izmjena u informacijama o proizvodu (vidjeti Dodatak III.).
English: Regarding Histophilus somni, only susceptibility data originated in Canada, USA and Europe were provided, showing the high susceptibility of the bacterium to enrofloxacin.
Croatian: U vezi sa Histophilus somni, dostavljeni su samo podaci o osjetljivosti koji potječu iz Kanade, SAD-a i Europe, te dokazuju visoku osjetljivost bakterije na enrofloksacin.
English: Bayer SpA Viale Certosa, 130 20156 Milano Italy
Croatian: Bayer SpA Viale Certosa, 130 20156 Milano Italija
English: Therefore the CVMP considered that these indications can be accepted for dogs and cats, when taking into account that the PK/PD data shown are theoretically predictive of good clinical efficacy in the treatment of the bacterial infections for which the products are intended, and the efficacy of the products has been confirmed by field studies and good clinical experience since more than two decades.
Croatian: Stoga je CVMP zaključio da se ove indikacije mogu prihvatiti za pse i mačke, ako se uzme u obzir da su FK/FD podaci teoretski pretpostavljali dobru kliničku djelotvornost u liječenju bakterijskih infekcija za koje je proizvod namijenjen, te da je djelotvornost proizvoda potvrđena terenskim ispitivanjem i dobrim kliničkim iskustvom duljim od dva desetljeća.
English: No resistance was found in samples from sheep and goats.
Croatian: Rezistencija nije utvrđena u uzorcima ovaca i koza.
English: Mare de Déu de Montserrat, 221
Croatian: Montserrat, 221
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to consider what indications, dosage regimens, duration of treatments and withdrawal periods should be applied to the concerned products for each target species in order to ensure efficacious treatment, consumer safety as well as lower the risk of development of antimicrobial resistance to enrofloxacin taking into account the available data.
Croatian: Od Odbora za veterinarsko-medicinske proizvode (CVMP) zatraženo je da razmotri koje indikacije, režimi doziranja, trajanje liječenja i razdoblja karencije treba primijeniti na predmetni proizvod za svaku ciljnu vrstu kako bi se osiguralo učinkovito liječenje, sigurnost potrošača i smanjio rizik razvoja antimikrobne rezistencije na enrofloksacin, uzimajući u obzir dostupne podatke.
English: A systematic review and meta-analysis of more than 50 studies showed a high efficacy of enrofloxacin in treating porcine respiratory disease complex although the etiological agents were no detailed.
Croatian: Sistemski pregled i meta analiza više od 50 ispitivanja pokazali su visoku djelotvornost enrofloksacina u liječenju kompleksa svinjskih respiratornih bolesti, iako etiologijska sredstva nisu bila detaljno navedena.
English: However, the provided results do not allow assessing the efficacy of the products for each one of these agents individually because only data about M. haemolytica have been provided.
Croatian: No, dostavljeni rezultati ne dozvoljavaju ocjenu djelotvornosti proizvoda za svako od navedenih sredstava posebno, zato što su dostavljeni podaci samo za patogene M. haemolytica.
English: All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Croatian: Svi mehanizmi dovode do smanjene osjetljivosti bakterija prema flurokinolonima.
English: Further to the assessment of the available data several contraindications and warning sentences are recommended to ensure the safe use of the products.
Croatian: Daljnjom ocjenom dostupnih podataka nekoliko preporučeno je nekoliko kontraindikacija i rečenica o upozorenju kako bi se osigurala sigurna primjena proizvoda.
English: The withdrawal period was statistically calculated by means of the TTSC method (i.e. where residues in all animals fall below the level considered safe within the time span for which data are available) resulting in 5.6 milkings / 3 days.
Croatian: Razdoblje karencije izračunato je statistički primjenom TTSC metode (primjerice kada su rezidui u svih životinja pali ispod razine koja se smatra sigurnom u okviru vremenskog raspona za koji su podaci bili dostupni) što je rezultiralo s 5,6 mužnji / 3 dana.
English: The CVMP considered the target species and associated indications and dosages can be accepted because all species are considered as minor species, and no concern on safety or on efficacy has been reported in the Member States where these target species are authorised.
Croatian: Mišljenje je CVMP-a da se ciljne vrste i povezane indikacije kao i doziranja mogu prihvatiti budući da se sve vrste smatraju manjim vrstama, te nema prijava o zabrinutosti za sigurnu primjenu ili djelotvornost u državama članicama u kojima su ove ciljne vrste odobrene.
English: In complicated infections, higher dosages and longer treatment courses may be necessary.
Croatian: Kod kompliciranih infekcija, veće doze i duže trajanje liječenja mogu biti neophodne.
English: Not authorised for use in animals producing milk for human consumption.
Croatian: Nije odobren za primjenu u životinja od kojih se mlijeko koristi za hranu.
English: Thus, the indication should be removed from the product information for the 50 mg/ml strength.
Croatian: Stoga se indikacija mora ukloniti iz informacija o proizvodu za jačinu od 50 mg/ml.
English: • on the basis of the available residue depletion data in cattle, pigs, sheep, goats and rabbits chickens and turkeys, the CVMP considered that withdrawal periods should be aligned to provide assurance for consumer safety;
Croatian: • je na temelju dostupnih podataka o pražnjenju rezidua u stoke, svinja, ovca, koza i zečeva, pilića i purana, CVMP zaključio da karenciju treba uskladiti kako bi se osigurala sigurnost potrošača;
English: These terms will apply to all age ranges and physiological status, as well as for both meat and/or milk production animals.
Croatian: Ti se uvjeti primjenjuju na sve dobne skupine i fiziološke statuse kao i na životinje koje se koriste za proizvodnju mesa i/ili mlijeka.
English: The term ‘young stock' should be replaced with ‘Cattle (calves)'.
Croatian: Pojam „mlada goveda” treba zamijeniti pojmom „ Goveda (telad)”.
English: Add, to all products: CONTRAINDICATIONS
Croatian: Dodati za sve lijekove: KONTRAINDIKACIJE
English: 4.1 Target species
Croatian: 4.1. Ciljne vrste
English: In conclusion the Committee can accept this indication considering that it is an injectable formulation, and that necessary restrictions provided in the SPC, together with the withdrawal period, would be in favour of a more adequate use of the veterinary medicinal product in rabbits compared to the use under the cascade.
Croatian: Naposljetku, Odbor može prihvatiti ovu indikaciju uzimajući u obzir da je to injektibilna formulacija, te da će potrebna ograničenja navedena u SPC-u, zajedno s razdobljem karencije, biti u korist primjerenije uporabe veterinarsko-medicinskog proizvoda u zečeva u usporedbi s primjenom „kaskade“.
English: Rev Sci Tech Off Int Epiz 2009;28:1119-1128
Croatian: Rev Sci Tech Off Int Epiz 2009;28:1119-1128 5 Agnoletti et al.
English: Although the scientific justification for this indication is not as robust as desirable, a clinical cure (response to treatment) of 87.5% was obtained in infections involving Staph.
Croatian: Iako znanstveno opravdanje za ovu indikaciju nije robusno u mjeri u kojoj bi to bilo poželjno, dobiven je klinički lijek (odgovor na liječenje) od 87,5% u infekcijama koje su uključivale Staph. aureus, zajedno s bakteriološkim lijekom od 66,67%.
English: The mode of action of enrofloxacin is bactericidal and bactericidal activity is concentration dependent.
Croatian: Mehanizam djelovanja enrofloksacina je baktericidan, a baktericidna aktivnost ovisna je o koncentraciji.
English: The presence of bacteria including E. coli was determined.
Croatian: Utvrđena je prisutnost bakterija, uključujući i E. coli.
English: Lower isolation index of E. coli in treated animals was observed.
Croatian: Uočen je niži indeks izolacije E. coli u liječenih životinja.
English: Finally, resistance to ciprofloxacin in Enterococcus bacteria varied from 0 to 29% in cattle and from 0 to 33% in pigs.
Croatian: Naposljetku, rezistencija na ciprofloksacin u bakterije Enterococcus varirala je od 0 do 29% u stoke te od 0 do 33% u svinja.
English: However, the analysis of the results did not allow differentiating the efficacy data and attribute to a particular posology regimen.
Croatian: No, analiza rezultata nije omogućila razlikovanje podataka o djelotvornosti i pripisivanje posebnog režima doziranja.
English: Metabolism of substances and activity of the immune system are, thus, critically dependent on the body temperature.
Croatian: Metabolizam tvari i aktivnost imunološkog sustava su ovisni o temperaturi tijela.
English: Benefit-risk assessment
Croatian: Ocjena koristi i rizika
English: A safety span of 30% was used to compensate for the deficiencies in the studies.
Croatian: Sigurnosni raspon od 30% korišten je za potrebe kompenziranja nedostataka u ispitivanjima.
English: Milk: 4 days.
Croatian: Mlijeko: 4 dana.
English: The available data showed that enrofloxacin is one of the most commonly used antimicrobials in lagomorphs to manage many different bacterial diseases because of its efficacy and safety.
Croatian: Dostupni su podaci pokazali da je enrofloksacin jedan od najčešće korištenih antimikrobnih sredstava u lagomorfa za liječenje mnogih različitih bakterijskih bolesti zbog svoje djelotvornosti i sigurne primjene.
English: The terms ‘Sheep and Goats' should be used instead of ‘Dairy ewes / lambs' and ‘Dairy goats/kids'.
Croatian: Pojam „Ovce i koze” treba koristiti umjesto „Mliječne ovce/janjad” i „Mliječne koze/jarići”.
English: Add, to all products: ADVICE ON CORRECT ADMINISTRATION
Croatian: Dodati za sve lijekove: SAVJETI ZA ISPRAVNU PRIMJENU
English: A field study compared 2 different durations of treatments (5 mg/kg bw for 3 or 5 days), but it did not compare the efficacy against an authorised product with a recognised efficacy for this indication.
Croatian: Terensko je ispitivanje usporedilo 2 različita trajanja liječenja (5 mg/kg tjelesne težine tijekom 3 ili 5 dana), no nije usporedilo djelotvornost s odobrenim proizvodom s prepoznatom djelotvornošću za ovu indikaciju.
English: In the case of Actinobacillus pleuropneumoniae several references were reviewed with experimental and field studies conducted in piglets and pigs.
Croatian: U slučaju patogena Actinobacillus pleuropneumoniae pregledano je nekoliko referenci s eksperimentalnim i terenskim ispitivanjima provedenima u praščića i svinja.
English: All treated animals showed a rapid improvement in mammary gland functions, and no clinical differences were found between the two treatment schedules.
Croatian: Sve liječene životinje pokazale su brzo poboljšanje u funkciji mliječnih žlijezdi, te nisu utvrđene kliničke razlike između dva rasporeda liječenja.
English: Regarding Pasteurella multocida, no particular conclusion could be drawn from the documentation provided, in view of the lack of precise microbiological data and considering that extrapolation of data from other formulations is not justified in this case.
Croatian: U slučaju patogena Pasteurella multocida, posebni se zaključci nisu mogli donijeti na temelju dostavljene dokumentacije u pogledu nedostatka preciznih mikrobioloških podataka i uzimajući u obzir da u ovom slučaju nije opravdana ekstrapolacija podataka iz drugih formulacija.
English: The Committte considered that the differences in excipients, as well as the different concentrations of active substance in the products concerned by this referral, do not affect residue depletion from the administration site in such a manner as would require different withdrawal periods for each formulation.
Croatian: Odbor je zaključio da razlike u dodatnim tvarima, kao i različite koncentracije djelatne tvari u proizvodima obuhvaćenima ovim postupkom upućivanja ne utječu na pražnjenje rezidua iz mjesta primjene na način koji bi zahtijevao različita razdoblja karencije za svaku formulaciju.
English: Additionally, the efficacy was demonstrated in several studies conducted in the USA with an arginin formulation of enrofloxacin at a 7.5 mg/kg bw dose.
Croatian: Nadalje, djelotvornost je demonstrirana u nekoliko ispitivanja provedenih u SAD-u s argininskom formulacijom enrofloksacina u dozi od 7,5 mg/kg tjelesne težine.
English: The presence of the renal portal system in reptiles means it is prudent to administer substances in the front half of the body wherever possible.
Croatian: Zbog renalnoportalnog sustava kod gmazova razumno je primijeniti lijek u prednjoj polovici tijela kada god je to moguće.
English: The study results indicate that the pharmacokinetics of enrofloxacin did not differ significantly between sheep and goats.
Croatian: Rezultati ispitivanja ukazuju da se farmakokinetika enrofloksacina nije značajno razlikovala u ovaca i koza.
English: In conclusion, this indication in sows can be accepted for the 100 mg/ml strength, but not for the 50 mg/ml strength, as the administration of the lower strength product is not practicable in heavy animals.
Croatian: Zaključno, ova indikacija u krmača može se prihvatiti za jačinu od 100 mg/ml, no ne i za jačinu od 50 mg/ml, budući da primjena proizvoda slabije jačine nije praktična u težih životinja.
English: Data on the MIC of different isolates of M.haemolytica confirms the high susceptibility of this pathogen to enrofloxacin, as well as a very low resistance rate.
Croatian: Podaci o različitim MIC-ovima različitih izolata M.haemolytica potvrđuju visoki stupanj osjetljivosti ovog patogena na enrofloksacin kao i vrlo nisku stopu rezistencije.
English: In case of complicated infections higher doses may be necessary.
Croatian: U slučaju kompliciranih infekcija mogu biti nužne i veće doze.
English: A field study showed the efficacy of the proposed dose comparing it with a reference product containing cefquinome.
Croatian: Terensko je ispitivanje pokazalo djelotvornost predložene doze uspoređujući je s referentnim proizvodom koji sadrži cefkinom.
English: - In another referral for an enrofloxacin oral solution (Hipralona Enro-S (EMEA/V/A/79))3 the Committee concluded that the risk is likely to be minor, in rabbits, in comparison with the other species due to the size of rabbit's production and no measures have been deemed necessary to minimize the risk for spread of methicillin resistant Staphylococcus aureus (MRSA) from those.
Croatian: - u drugom postupku upućivanja za oralnu otopinu enrofloksacina (Hipralona Enro-S (EMEA/V/A/79))3, Odbor je zaključio kako je izgledno da će rizik u zečeva biti manji u usporedbi s rizikom u drugih vrsta uslijed veličine uzgoja zečeva, te se nikakve mjere ne smatraju potrebnima za smanjivanje rizika od širenja Staphylococcus aureus otpornog na meticilin (MRSA) s njih.
English: The documentation provided was exactly the same, and both strengths (50 mg/ml and 100 mg/ml) have the same withdrawal periods.
Croatian: Dostavljena dokumentacija bila je u potpunosti ista, a obje jačine (50 mg/ml i 100 mg/ml) imaju ista razdoblja karencije.
English: Neither was appropriate for analysis using the statistical method.
Croatian: Niti jedno ispitivanje nije primjereno za analizu primjenom statističke metode.
English: Enrofloxacin is also authorised for administration by oral route in farm rabbits all over Europe, and therefore CVMP considered that the use of an injectable solution could lead to a lesser exposure than the oral route as it can be individually administered to sick animals (with more precise dosage based on individual weights of animals) and can prevent the use in mass treatment.
Croatian: Enrofloksacin je također odobren za primjenu oralnim putem u zečeva na farmama diljem Europe, te je stoga CVMP zaključio da primjena injektibilne otopine može rezultirati manjim izlaganjem od one oralnim putem budući da se može individualno primijeniti u bolesnih životinja (s preciznijim doziranjem temeljenim na individualnoj težini životinja), a može spriječiti primjenu u masovnom liječenju.
English: Dose determination and dose confirmation studies demonstrated the efficacy of the recommended dose.
Croatian: Ispitivanja za utvrđivanje doze i potvrđivanje doze pokazuju djelotvornost preporučene doze.
English: aureus LAMRSA (ST398, spa types t034 and t5210) occurring in rabbits raised intensively for meat production and involving farm workers or their family members5.
Croatian: Aureus otpornog na metilicin povezanog sa stokom LAMRSA (ST398, spa tipovi t034 i t5210) koji je nastupio u zečeva uzgajanih intenzivno za potrebe mesa i uključivao radnike na farmi ili članove njihovih obitelji5.
English: The results from an experimental study and a field study were provided.
Croatian: Dostavljeni su podaci eksperimentalnog ispitivanja i terenskog ispitivanja.
English: The remaining indications i.e. mastitis, alimentary tract infections and septicaemia were extrapolated from sheep.
Croatian: Preostale indikacije, odnosno mastitis, infekcije probavnog trakta i septikemija su ekstrapolirane iz ovaca.
English: 220 Avenue de la Recherche 59120 LOOS
Croatian: Francuska Bayer Sante 220 Avenue de la Recherche 59120 LOOS
English: No field studies were submitted to support the indications in goats.
Croatian: Nisu dostavljena terenska ispitivanja u prilog indikacijama u koza.
English: In support of the efficacy data, published literature was provided, but, generally, lacking specific data and employing variable posology regimens.
Croatian: U prilog podataka o djelotvornosti dostavljena je objavljena literatura, no načelno nedostaju specifični podaci i primijenjeni varijabilni režimi doziranja.
English: All available clinical data referred to pet rabbits only.
Croatian: Svi dostupni klinički podaci odnose se samo na zečeve koji se drže kao kućni ljubimci.