FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Celotno razmerje med tveganji in koristmi za zdravila, vključena v ta postopek, je bilo ocenjeno kot ugodno pod pogojem, da se upoštevajo priporočene spremembe v informacijah o zdravilu (glejte Prilogo III).
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.
Slovenian: Pričakuje se, da uporaba teh zdravil za to indikacijo ne bo velika, saj je treba zdravilo kuncem parenteralno dajati z vsakodnevnim injiciranjem, ki traja od 5 do 10 dni.
English: aureus multi-resistant to several types of antimicrobials are currently documented and (iii) that there can be a transfer of resistant bacteria from animals to humans, involving both consumers and handlers of rabbits.
Slovenian: aureus, ki so multirezistentni proti več vrstam antibiotikov, in (iii) lahko pride do prenosa odpornih bakterij z živali na ljudi, vključno s potrošniki in rejci kuncev.
English: Romikim Farma SL Gran Via Carlos III, 98,6 8027 Barcelona Spain
Slovenian: Nizozemska Romikim Farma SL Gran Via Carlos III, 98,6 8027 Barcelona
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.
Slovenian: Kritični FK parametri v mleku so bili določeni po intravenski uporabi jakosti 100 mg/ml in so bili uporabljeni za izračun napovednega FK/FD razmerja skupaj z vrednostmi MIK90 za E. coli.
English: Dose determination and dose confirmation studies demonstrated the efficacy of the recommended dose.
Slovenian: Študije za določanje in potrditev odmerka so pokazale učinkovitost priporočenega odmerka.
English: All residues were below the MRL on the 4th milking (48 hours).
Slovenian: Vse vrednosti so bile pod MVO ob 4. molži (po 48 urah).
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.
Slovenian: Enrofloksacin je v celotni Evropi odobren tudi za peroralno uporabo pri rejnih kuncih, zato je odbor CVMP menil, da bi lahko uporaba raztopine za injiciranje povzročila manjšo izpostavljenost kot peroralna uporaba, saj se lahko daje posameznim bolnim živalim (z natančnejšim odmerjanjem na podlagi mase posamezne živali), in preprečila uporabo masovnega zdravljenja.
English: In complicated infections, higher dosages and longer treatment courses may be necessary.
Slovenian: Pri zapletenih okužbah bodo morda potrebni večji odmerki in daljše zdravljenje.
English: Add, to all products:
Slovenian: Dodajte vsem zdravilom:
English: The remaining indications i.e. mastitis, alimentary tract infections and septicaemia were extrapolated from sheep.
Slovenian: Preostale indikacije, tj. mastitis, okužbe prebavil in septikemija, so bile ekstrapolirane iz podatkov za ovce.
English: Better clinical results were observed in 3-4 weeks old animals compared to 1-2 weeks old animals.
Slovenian: Pri živalih, starih od 3 do 4 tedne, so opazili boljše rezultate kot pri živalih, starih od 1 do 2 tedna.
English: A field study showed the efficacy of the proposed dose comparing it with a reference product containing cefquinome.
Slovenian: Terenska študija je pokazala učinkovitost predlaganega odmerka v primerjavi z referenčnim zdravilom, ki je vsebovalo cefkvinom.
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.
Slovenian: Poleg tega so učinkovitost dokazali v več študijah, izvedenih v ZDA z argininsko formulacijo enrofloksacina v odmerku 7,5 mg/kg telesne mase.
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.
Slovenian: Študijo so izvedli samo z 12 živalmi, zato statistične analize8 podatkov ni bilo mogoče opraviti in so karenco izpeljali z alternativnim pristopom.
English: Germany Calluna Pharma bvba Treslong 34
Slovenian: Calluna Pharma bvba Treslong 34
English: The presence of bacteria including E. coli was determined.
Slovenian: Ugotovili so prisotnost bakterij, vključno z E. coli.
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.
Slovenian: Velika učinkovitost enrofloksacina pri zdravljenju sindroma MMA je bila potrjena z metaanalizo in sistematičnim pregledom 6 kliničnih študij in študij občutljivosti pri MMA/PDS in enrofloksacinu v obdobju med letoma 1990 in 1998.
English: In support of the efficacy data, published literature was provided, but, generally, lacking specific data and employing variable posology regimens.
Slovenian: Kot podpora za podatke o učinkovitosti je bila predložena objavljena literatura, vendar je na splošno vsebovala pomanjkljive specifične podatke in spremenljive režime odmerjanja.
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.
Slovenian: Čeprav konji niso odobrena ciljna živalska vrsta, je odbor menil, da mora biti kontraindikacija za uporabo pri rastočih konjih vključena v informacije o zdravilu, in sicer za jakosti 50 mg/ml in 100 mg/ml.
English: In the milk samples the pathogens Staph.
Slovenian: V vzorcih mleka so ugotovili patogena Staph.
English: GENERA Slovenia d.o.o.
Slovenian: Slovenija GENERA Slovenia d.o.o.
English: Milk: 4 days.
Slovenian: Mleko: 4 dni.
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.
Slovenian: - V drugem napotitvenem postopku za peroralno raztopino enrofloksacina (Hipralona Enro-S (EMEA/V/A/79))3 je odbor sklenil, da je verjetnost za tveganje pri kuncih majhna v primerjavi z drugimi vrstami zaradi velikosti proizvodnje kuncev, in ni določil nobenih ukrepov, potrebnih za zmanjševanje tveganja širjenja proti meticilinu odpornega Staphylococcus aureus (MRSA).
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.
Slovenian: na podlagi predložene dokumentacije niso mogoči posebni sklepi, saj so natančni mikrobiološki podatki pomanjkljivi (ne omogočajo ocene učinkovitosti zdravila proti posameznim izoliranim mikroorganizmom) in ker ne pride do popolnega izločanja M. hyopneumoniae.
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.
Slovenian: Uporaba, neskladna z informacijami o zdravilu, prepusti odločanje glede odmerjanja veterinarju in predstavlja morebitno tveganje napačne uporabe, kar bi lahko povečalo tveganje razvoja antimikrobne odpornosti.
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.
Slovenian: Sistematski pregled in metaanaliza več kot 50 študij sta pokazala veliko učinkovitost enrofloksacina pri zdravljenju prašičje bolezni dihal, čeprav ni bilo podrobnih podatkov o povzročiteljih.
English: Thus, the indication should be removed from the product information for the 50 mg/ml strength.
Slovenian: Posledično je treba to indikacijo odstraniti iz informacij o zdravilu za jakost 50 mg/ml.
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.
Slovenian: Odbor je menil, da razlike v pomožnih snoveh in različne koncentracije zdravilne učinkovine v zdravilih, vključenih v ta napotitveni postopek, ne vplivajo na izločanje ostankov iz mesta uporabe na način, ki bi zahteval različne karence za posamezne formulacije.
English: The latter also applies for alimentary tract infections and septicaemia caused by E. coli in pigs.
Slovenian: Slednje velja tudi za okužbe prebavil in septikemijo, ki jo povzroča E. coli, pri prašičih.
English: However, the analysis of the results did not allow differentiating the efficacy data and attribute to a particular posology regimen.
Slovenian: Vendar analiza rezultatov ni omogočila razlikovanja med podatki o učinkovitosti in posameznimi režimi odmerjanja.
English: In case of complicated infections higher doses may be necessary.
Slovenian: Pri zapletenih okužbah bodo morda potrebni večji odmerki.
English: To compensate for deficiencies in the studies a safety span of 20% was considered appropriate, resulting in a withdrawal period of 96 hours (4 days).
Slovenian: Odbor je menil, da je za kompenzacijo za pomanjkljivosti študij, ustrezen 20odstotni varnostni razpon, kar pomeni karenco 96 ur (4 dni).
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.
Slovenian: Podatki o vrednosti MIK različnih izolatov M.haemolytica potrjujejo veliko občutljivost tega patogena za enrofloksacin in zelo majhen delež odpornosti.
English: Ornamental birds
Slovenian: Okrasne ptice
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.
Slovenian: Podatki kažejo, da se na splošno velika občutljivost za enrofloksacin opaža pri večini sevov govejih ter prašičjih respiratornih patogenov in pri neenterični E. coli.
English: A safety span of 30% was used to compensate for the deficiencies in the studies.
Slovenian: Odbor je menil, da je za kompenzacijo za pomanjkljivosti študij ustrezen 30-odstotni varnostni razpon.
English: Furthermore, the veterinary practitioner will be left without an authorised product for the treatment of skin and wound infections caused by Staph.
Slovenian: Poleg tega veterinar ne bo imel na voljo nobenega odobrenega zdravila za zdravljenje okužb kože in ran pri kuncih, ki jih povzroča Staph.
English: Finally, resistance to ciprofloxacin in Enterococcus bacteria varied from 0 to 29% in cattle and from 0 to 33% in pigs.
Slovenian: Odpornost bakterije Enterococcus proti ciprofloksacinu je bila od 0- do 29-odstotna pri govedu in od 0do 33-odstotna pri prašičih.
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.
Slovenian: Na podlagi splošnih podatkov, ki so jih predložili imetniki dovoljenj za promet z zdravilom (podatkov o učinkovitosti, FK/FD in podatkov o odpornosti ciljnih patogenov), je mogoče sklepati, da odmerek 2,5 mg/kg telesne mase/dan (čeprav je v nekaterih primerih pokazal relativno dobro učinkovitost) morda ne bo zadostoval za popolno eliminacijo bakterije in lahko povzroči razvoj odpornosti E. coli.
English: All available clinical data referred to pet rabbits only.
Slovenian: Vsi razpoložljivi podatki so se nanašali samo na hišne kunce.
English: In the case of dermatitis caused by Staph.
Slovenian: Za indikacijo dermatitisa pri kuncih, ki ga povzroča Staph.
English: Cattle (subcutaneous)
Slovenian: Govedo (subkutano)
English: Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Slovenian: Navzkrižna odpornost znotraj razreda fluorokinolonov je pogosta.
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.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) so prosili, naj na podlagi razpoložljivih podatkov preveri katere indikacije, režimi odmerjanja, trajanja zdravljenja in karence naj se uporabijo za zadevna zdravila pri posameznih ciljnih živalskih vrstah, da bi zagotovili učinkovito zdravljenje, varnost potrošnikov ter zmanjšali tveganje razvoja odpornosti mikroorganizmov na enrofloksacin.
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.
Slovenian: Terenska študija je primerjala 2 različni trajanji zdravljenja (5 mg/kg telesne mase 3 ali 5 dni), vendar ni primerjala učinkovitosti glede na odobreno zdravilo s potrjeno učinkovitostjo za to indikacijo.
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).
Slovenian: Posledično je treba indikacije pri rejnih kuncih obravnavati kot ekstrapolacijo iz drugih podatkov (peroralne uporabe pri rejnih kuncih in/ali injiciranja pri hišnih kuncih).
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.
Slovenian: Posledično se lahko ta indikacija pri svinjah sprejme za jakost 100 mg/ml, vendar ne za jakost 50 mg/ml, saj uporaba manjše jakosti pri težkih živalih ni mogoča.
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.
Slovenian: Za optimizacijo odmerka in preprečevanje razvoja odpornosti so sklenili, da je treba odmerjanje 2,5 mg/kg telesne mase/dan izbrisati iz vseh indikacij pri govedu.
English: A multi-centric comparative field trial in sows has been provided.
Slovenian: Predložilo se je multicentrično primerjalno terensko preskušanje pri svinjah.
English: If necessary, depending on the severity of clinical signs, this dosage can be doubled.
Slovenian: Odmerek se lahko podvoji, če je to potrebno glede na resnost kliničnih znakov.
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.
Slovenian: Na podlagi predložene dokumentacije niso mogoči posebni sklepi glede Pasteurella multocida, saj so natančni mikrobiološki podatki pomanjkljivi, ekstrapolacija podatkov na podlagi drugih formulacij pa v tem primeru ni upravičena.
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.
Slovenian: V teh študijah so uporabili različne odmerke (splošen razpon od 1 do 6 mg/kg telesne mase/dan), načrt študij pa ni omogočal ocene učinkovitosti posameznih odmerkov.
English: To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Slovenian: Da bi zagotovili uporabo ustreznega odmerka, je treba čim natančneje določiti telesno maso, saj se s tem prepreči premajhno odmerjanje.
English: Where the following target species have already been approved, the wording below relating to the relevant species should be used:
Slovenian: Če so bile spodaj navedene ciljne živalske vrste že odobrene, je treba uporabiti spodnja besedila, ki se nanašajo na zadevne živalske vrste:
English: The CVMP recommended the removal of the indication from the product information.
Slovenian: Odbor CVMP je priporočil izbris te indikacije iz informacij o zdravilu.
English: However, there are concerns regarding the moderate to high resistance rates observed in enteric E. coli isolated from cattle and pigs.
Slovenian: Vendar pa obstajajo zadržki, povezani z zmernimi do velikimi deleži odpornosti, ki so jih opazili pri enterični E. coli, izolirani iz goveda in prašičev.
English: Similarly, for Mycoplasma spp.
Slovenian: Tudi pri Mycoplasma spp.
English: Treatment may be initiated with injectable product and maintained with enrofloxacin tablets.
Slovenian: Zdravljenje se lahko uvede z zdravilom za injiciranje in nadaljuje s tabletami enrofloksacina.
English: - A study described the first case of livestock-associated methicillin-resistant Staph.
Slovenian: - Študija je opisala prvi primer z živino povezanega, proti meticilinu odpornega Staph.
English: Intramuscular administration of enrofloxacin showed to be effective especially in cases of enterotoxaemia.
Slovenian: Pokazali so, da je intramuskularna uporaba enrofloksacina učinkovita, predvsem pri primerih enterotoksemije.
English: All treated animals showed a rapid improvement in mammary gland functions, and no clinical differences were found between the two treatment schedules.
Slovenian: Pri vseh zdravljenih živalih je prišlo do hitrega izboljšanja delovanja mlečnih žlez, med shemama zdravljenja pa niso ugotovili nobenih kliničnih razlik.
English: Treatment with enrofloxacin significantly reduced the incidence and severity of diarrhoea.
Slovenian: Zdravljenje z enrofloksacinom je pomembno zmanjšalo incidenco in resnost driske.
English: The mode of action of enrofloxacin is bactericidal and bactericidal activity is concentration dependent.
Slovenian: Enrofloksacin deluje baktericidno, pri čemer je njegovo baktericidno delovanje odvisno od koncentracije.
English: No resistance was found in samples from sheep and goats.
Slovenian: Pri vzorcih iz ovc in koz niso ugotovili nobene odpornosti.
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.
Slovenian: Razpoložljivi podatki so pokazali, da je enrofloksacin zaradi svoje učinkovitosti in varnosti eden najpogosteje uporabljenih antibiotikov pri lagomorfih za obravnavo mnogih različnih bakterijskih bolezni.
English: Belgium Vandenbussche Farma Service Brusselsesteenweg 396
Slovenian: Vandenbussche Farma Service Brusselsesteenweg 396 1980 Eppegem
English: aureus isolated from goat mastitis was also very low.
Slovenian: aureus, izoliran pri kozah z mastitisom, prav tako zelo majhen.
English: The Cmax/MIC and AUC/MIC ratios for Staphylococcus spp.
Slovenian: Razmerja Cmax/MIK in AUC/MIK za Staphylococcus spp.
English: Sheep and goats
Slovenian: Ovce in koze
English: aureus resistance, (ii) isolates of Staph.
Slovenian: aureus, (ii) so trenutno dokumentirani izolati Staph.
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.
Slovenian: Odbor CVMP je v dokumentu s stališčem glede razpoložljivosti zdravil za manj pomembno uporabo in manj pomembne živalske vrste (EMEA/CVMP/477/03)1 ugotovil, da so govedo (živali za proizvodnjo mleka in mesa) in ovce (živali za proizvodnjo mesa) pomembnejše živalske vrste za proizvodnjo hrane.
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.
Slovenian: Intramuskularno injiciranje enrofloksacina v odmerku 2,5 mg/kg telesne mase enkrat na dan, ki je trajalo, dokler se niso klinični znaki bolezni dihal zmanjšali, je povzročilo 94,5-odstotno uspešnost.
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.
Slovenian: Enrofloksacin je pokazal boljše klinične rezultate kot oksitetraciklin pri vseh odmerkih, saj je prišlo do hitrejšega zmanjšanja skupnih kliničnih rezultatov in rezultatov gostote blata.
English: The documentation provided was exactly the same, and both strengths (50 mg/ml and 100 mg/ml) have the same withdrawal periods.
Slovenian: Priložena dokumentacija je bila popolnoma ista in obe jakosti (50 mg/ml in 100 mg/ml) imata enake karence.
English: The results showed that all groups of medicated piglets increased in weight thus contrasting the control animals that were not treated with enrofloxacin.
Slovenian: Rezultati so pokazali, da se je v vseh skupinah pri zdravljenih pujskih povečala telesna masa, kar se ni zgodilo pri kontrolnih živalih, ki niso bile zdravljene z enrofloksacinom.
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.
Slovenian: Poročali so, da je odpornost proti fluorokinolonom posledica petih virov: i) točkastih mutacij v genih, ki kodirajo DNA-girazo in/ali topoizomerazo IV, kar privede do sprememb zadevnega encima, ii) sprememb pri permeabilnosti zdravila pri gramnegativnih bakterijah, iii) mehanizmov prehajanja zdravila skozi membrano, iv) odpornosti, ki jo povzročajo plazmidi, in v) beljakovin, ki ščitijo girazo.
English: In another study after five months at the end of the study, no enrofloxacin resistant bacteria could be isolated from the treated sows.
Slovenian: Pet mesecev po koncu druge študije niso izolirali nobene na enrofloksacin odporne bakterije pri zdravljenih svinjah.
English: The results of different field studies in piglets with enteritis were summarised.
Slovenian: Pripravili so povzetek rezultatov različnih terenskih študij na pujskih z enteritisom.
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.
Slovenian: Pri indikaciji za zdravljenje okužb kože in ran, ki jih povzroča Staphylococcus aureus, so razpoložljivi podatki kazali na nepopolno bakteriološko ozdravitev, FK/FD podatki pa niso bili na voljo.
English: Clinical outcome was demonstrated on sows with MMA/PDS treated with enrofloxacin.
Slovenian: Klinični izid so pokazali na svinjah z MMA/PDS, zdravljenih z enrofloksacinom.
English: Duration of treatment should be based on the duration of treatment approved for the appropriate indication in the product information of the tablet product.
Slovenian: Trajanje zdravljenja mora temeljiti na trajanju zdravljenja, ki je za ustrezno indikacijo odobreno v informacijah o zdravilu za zdravilo v obliki tablet.