natgillin/translations-raw huggingface dataset:
Thus, the indication should be removed from the product information for the 50 mg/ml strength.
Posledično je treba to indikacijo odstraniti iz informacij o zdravilu za jakost 50 mg/ml.
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.
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.
The latter also applies for alimentary tract infections and septicaemia caused by E. coli in pigs.
Slednje velja tudi za okužbe prebavil in septikemijo, ki jo povzroča E. coli, pri prašičih.
However, the analysis of the results did not allow differentiating the efficacy data and attribute to a particular posology regimen.
Vendar analiza rezultatov ni omogočila razlikovanja med podatki o učinkovitosti in posameznimi režimi odmerjanja.
In case of complicated infections higher doses may be necessary.
Pri zapletenih okužbah bodo morda potrebni večji odmerki.
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).
Odbor je menil, da je za kompenzacijo za pomanjkljivosti študij, ustrezen 20odstotni varnostni razpon, kar pomeni karenco 96 ur (4 dni).
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.
Podatki o vrednosti MIK različnih izolatov M.haemolytica potrjujejo veliko občutljivost tega patogena za enrofloksacin in zelo majhen delež odpornosti.
Ornamental birds
Okrasne ptice
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.
Podatki kažejo, da se na splošno velika občutljivost za enrofloksacin opaža pri večini sevov govejih ter prašičjih respiratornih patogenov in pri neenterični E. coli.
A safety span of 30% was used to compensate for the deficiencies in the studies.
Odbor je menil, da je za kompenzacijo za pomanjkljivosti študij ustrezen 30-odstotni varnostni razpon.
Furthermore, the veterinary practitioner will be left without an authorised product for the treatment of skin and wound infections caused by Staph.
Poleg tega veterinar ne bo imel na voljo nobenega odobrenega zdravila za zdravljenje okužb kože in ran pri kuncih, ki jih povzroča Staph.
Finally, resistance to ciprofloxacin in Enterococcus bacteria varied from 0 to 29% in cattle and from 0 to 33% in pigs.
Odpornost bakterije Enterococcus proti ciprofloksacinu je bila od 0- do 29-odstotna pri govedu in od 0do 33-odstotna pri prašičih.
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.
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.
All available clinical data referred to pet rabbits only.
Vsi razpoložljivi podatki so se nanašali samo na hišne kunce.
In the case of dermatitis caused by Staph.
Za indikacijo dermatitisa pri kuncih, ki ga povzroča Staph.
Cattle (subcutaneous)
Govedo (subkutano)
Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Navzkrižna odpornost znotraj razreda fluorokinolonov je pogosta.
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.
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.
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.
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.
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).
Posledično je treba indikacije pri rejnih kuncih obravnavati kot ekstrapolacijo iz drugih podatkov (peroralne uporabe pri rejnih kuncih in/ali injiciranja pri hišnih kuncih).
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.
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.
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.
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.
A multi-centric comparative field trial in sows has been provided.
Predložilo se je multicentrično primerjalno terensko preskušanje pri svinjah.
If necessary, depending on the severity of clinical signs, this dosage can be doubled.
Odmerek se lahko podvoji, če je to potrebno glede na resnost kliničnih znakov.
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.
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.
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.
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.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Da bi zagotovili uporabo ustreznega odmerka, je treba čim natančneje določiti telesno maso, saj se s tem prepreči premajhno odmerjanje.
Where the following target species have already been approved, the wording below relating to the relevant species should be used:
Če so bile spodaj navedene ciljne živalske vrste že odobrene, je treba uporabiti spodnja besedila, ki se nanašajo na zadevne živalske vrste:
The CVMP recommended the removal of the indication from the product information.
Odbor CVMP je priporočil izbris te indikacije iz informacij o zdravilu.
However, there are concerns regarding the moderate to high resistance rates observed in enteric E. coli isolated from cattle and pigs.
Vendar pa obstajajo zadržki, povezani z zmernimi do velikimi deleži odpornosti, ki so jih opazili pri enterični E. coli, izolirani iz goveda in prašičev.
Similarly, for Mycoplasma spp.
Tudi pri Mycoplasma spp.
Treatment may be initiated with injectable product and maintained with enrofloxacin tablets.
Zdravljenje se lahko uvede z zdravilom za injiciranje in nadaljuje s tabletami enrofloksacina.
- A study described the first case of livestock-associated methicillin-resistant Staph.
- Študija je opisala prvi primer z živino povezanega, proti meticilinu odpornega Staph.
Intramuscular administration of enrofloxacin showed to be effective especially in cases of enterotoxaemia.
Pokazali so, da je intramuskularna uporaba enrofloksacina učinkovita, predvsem pri primerih enterotoksemije.
All treated animals showed a rapid improvement in mammary gland functions, and no clinical differences were found between the two treatment schedules.
Pri vseh zdravljenih živalih je prišlo do hitrega izboljšanja delovanja mlečnih žlez, med shemama zdravljenja pa niso ugotovili nobenih kliničnih razlik.
Treatment with enrofloxacin significantly reduced the incidence and severity of diarrhoea.
Zdravljenje z enrofloksacinom je pomembno zmanjšalo incidenco in resnost driske.
The mode of action of enrofloxacin is bactericidal and bactericidal activity is concentration dependent.
Enrofloksacin deluje baktericidno, pri čemer je njegovo baktericidno delovanje odvisno od koncentracije.
No resistance was found in samples from sheep and goats.
Pri vzorcih iz ovc in koz niso ugotovili nobene odpornosti.
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.
Razpoložljivi podatki so pokazali, da je enrofloksacin zaradi svoje učinkovitosti in varnosti eden najpogosteje uporabljenih antibiotikov pri lagomorfih za obravnavo mnogih različnih bakterijskih bolezni.
aureus isolated from goat mastitis was also very low.
aureus, izoliran pri kozah z mastitisom, prav tako zelo majhen.
The Cmax/MIC and AUC/MIC ratios for Staphylococcus spp.
Razmerja Cmax/MIK in AUC/MIK za Staphylococcus spp.
aureus resistance, (ii) isolates of Staph.
aureus, (ii) so trenutno dokumentirani izolati Staph.
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.
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.
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.
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.
Enrofloxacin showed better clinical results than oxytetracyclin at all dose levels, with a more rapid decrease of total clinical scores and faecal consistency scores.
Enrofloksacin je pokazal boljše klinične rezultate kot oksitetraciklin pri vseh odmerkih, saj je prišlo do hitrejšega zmanjšanja skupnih kliničnih rezultatov in rezultatov gostote blata.
The documentation provided was exactly the same, and both strengths (50 mg/ml and 100 mg/ml) have the same withdrawal periods.
Priložena dokumentacija je bila popolnoma ista in obe jakosti (50 mg/ml in 100 mg/ml) imata enake karence.
The results showed that all groups of medicated piglets increased in weight thus contrasting the control animals that were not treated with enrofloxacin.
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.
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.
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.
In another study after five months at the end of the study, no enrofloxacin resistant bacteria could be isolated from the treated sows.
Pet mesecev po koncu druge študije niso izolirali nobene na enrofloksacin odporne bakterije pri zdravljenih svinjah.
The results of different field studies in piglets with enteritis were summarised.
Pripravili so povzetek rezultatov različnih terenskih študij na pujskih z enteritisom.
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.
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.
Clinical outcome was demonstrated on sows with MMA/PDS treated with enrofloxacin.
Klinični izid so pokazali na svinjah z MMA/PDS, zdravljenih z enrofloksacinom.
Duration of treatment should be based on the duration of treatment approved for the appropriate indication in the product information of the tablet product.
Trajanje zdravljenja mora temeljiti na trajanju zdravljenja, ki je za ustrezno indikacijo odobreno v informacijah o zdravilu za zdravilo v obliki tablet.
A 20% safety span was considered appropriate to compensate for the small number of animals used in the study.
Odbor je menil, da je za kompenzacijo za majhno število živali, vključenih v študijo, ustrezen 20-odstotni varnostni razpon.
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.
Sočasna uporaba enrofloksacina in fluniksina je zato pri psih povečala AUC in podaljšala razpolovni čas izločanja fluniksina ter podaljšala razpolovni čas izločanja in zmanjšala Cmax enrofloksacina.
Confirmatory field trials showed clinical efficacy of the dose of 5 mg/kg bw/day rather than the lower dose.
Potrditvena terenska preskušanja so pokazala klinično učinkovitost odmerka 5 mg/kg telesne mase/dan in ne manjšega odmerka.
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.
Mleko (jakosti 50 mg/ml in 100 mg/ml): Ker zadevna zdravila ne puščajo lokalnih ostankov v mleku, se lahko karenca, določena za pomembnejše vrste, neposredno ekstrapolira na manj pomembne vrste brez uporabe varnostnega razpona.
The efficacy of enrofloxacin for the treatment of acute mastitis was investigated in a field trial in sheep with clinical signs of acute mastitis.
Učinkovitost enrofloksacina pri zdravljenju akutnega mastitisa so preučevali v terenskem preskušanju na ovcah s kliničnimi znaki akutnega mastitisa.
aureus in rabbits, no other veterinary medicinal products are authorised for this indication in this animal species in the EU.
aureus, v EU ni odobreno nobeno drugo zdravilo za uporabo v veterinarski medicini.
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.
Vendar pa predloženi rezultati niso omogočili ocene učinkovitosti zdravil za posamezne povzročitelje, saj so bili predloženi samo podatki za
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.
Predložena je bila dokumentacija, ki opisuje uporabo zdravil za injiciranje za uporabo v veterinarski medicini pri zdravljenju okužb prebavil ter dihal in zdravljenju okužb kože in ran.
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The decrease in drug clearances as a result of co-administration of flunixin and enrofloxacin indicates that these substances interact during the elimination phase.
Zmanjšanje očistkov zdravil, ki je posledica sočasne uporabe fluniksina in enrofloksacina, kaže na medsebojno delovanje teh dveh zdravil med procesom izločanja.
A second dose-titration trial was conducted in Japan with natural infection caused by E. coli in suckling piglets.
Drugo preskušanje za titracijo odmerka so izvedli na Japonskem z naravno okužbo, ki jo pri sesnih pujskih povzroča E. coli.
The PK/PD analysis shows that the PK/PD ratios are largely exceeded for Gram-negative pathogens.
Analiza FK/FD podatkov je pokazala, da so razmerja FK/FD za gramnegativne patogene izjemno presežena.
• 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;
• odbor CVMP je menil, da je treba na podlagi razpoložljivih podatkov odmerjanje 2,5 mg/kg telesne mase/dan izbrisati pri indikacijah za okužbe prebavil in septikemije zaradi E. coli pri prašičih;
Enrofloxacin is reported to have deleterious effect on articular cartilage in growing horses.
Poročali so, da ima enrofloksacin škodljiv učinek na sklepni hrustanec pri rastočih konjih.
It is therefore appropriate to derive a single harmonised withdrawal period based on the totality of residue data from all formulation groups.
Zato je primerno, da se na podlagi skupnih podatkov o ostankih iz vseh skupin formulacij izpelje ena usklajena karenca.
Therefore only the dose of 5 mg/kg bw for 3-5 days is supported.
Zato je bil podprt samo odmerek 5 mg/kg telesne mase od 3 do 5 dni.
Milk (100 mg/ml strength): Only one residue depletion study in cattle milk was considered adequate for the purpose of setting a withdrawal period in milk.
Mleko (jakost 100 mg/ml): Samo ena študija izločanja ostankov iz kravjega mleka se je štela za zadostno za namene ugotavljanja karence za mleko.
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.
Replikacijske vilice in kompleksi za translacijo ne morejo preko kompleksov, ki jih tvorijo encim, DNA in fluorokinolon, zaviranje sinteze DNA in mRNA pa sproži dogodke, ki privedejo do hitrega, od koncentracije odvisnega uničenja patogenih bakterij.
aureus and E. coli were identified.
aureus in E. coli.
The authors concluded that resistance to antimicrobial agents in Staph.
Avtorji so zaključili, da je odpornost na antibiotike pri izolatih Staph.
A dose-confirmation study and a field study showed clinical efficacy of the dose of 5 mg/kg bw/day against enzootic pneumonia caused by M. haemolytica and P. multocida.
Študija za potrditev odmerka in terenska študija sta pokazali klinično učinkovitost odmerka 5 mg/kg telesne mase/dan proti enzootični pljučnici, ki jo povzročata M. haemolytica in
The terms ‘Sheep and Goats' should be used instead of ‘Dairy ewes / lambs' and ‘Dairy goats/kids'.
Namesto izrazov „ovce molznice/jagnjeta“ in „koze molznice/kozlički“ je treba uporabiti izraza „ovce in koze“.
Injectable enrofloxacin decreased diarrhoea incidence up to 70% in suckling piglets.
Injicirani enrofloksacin je incidenco driske pri sesnih pujskih zmanjšal za do 70 %.
4.8 Interaction with other medicinal products and other forms of interaction Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions.
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pri sočasni uporabi fluniksina in enrofloksacina pri psih je potrebna previdnost, da se prepreči neželene učinke zdravila.
Intestinal bacterial counts were significantly reduced by treatment with 2.5 mg/kg bw/day.
Število črevesnih bakterij se je pomembno zmanjšalo pri zdravljenju z odmerkom 2,5 mg/kg telesne mase/dan.
aureus) was 39.5% in the 2.5 mg/kg group and 82% in the 5 mg/kg group.
aureus) v skupini 2,5 mg/kg telesne mase je bil 39,5 %, v skupini s 5 mg/kg telesne mase pa
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Different tolerance studies were conducted in calves with oral administration of enrofloxacin.
Pri teletih so izvedli različne študije tolerance s peroralnim enrofloksacinom.
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.
Rezultati predloženih študij kažejo, da je bila spremenljivost profila ostankov zaradi virov spremenljivosti, povezanih z injiciranjem teh zdravil (npr.
Target species, indications and posology
Ciljne vrste, indikacije in odmerjanje
In a study the pharmacokinetics of enrofloxacin were compared in Desert sheep and Nubian goats after intravenous and intramuscular administration at 5 mg/kg bw dose.
V študiji so primerjali farmakokinetiko enrofloksacina pri puščavskih ovcah ter nubijskih kozah po intravenski in intramuskularni uporabi odmerka 5 mg/kg telesne mase.
• on the basis of the available data, the CVMP considered that indications as provided in Annex III
• odbor CVMP je na podlagi razpoložljivih podatkov menil, da so te indikacije, kot so navedene v Prilogi III, utemeljene;
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.
Meso in organi (jakosti 50 mg/ml in 100 mg/ml): Skladno s smernico CVMP o zahtevah za podatke o varnosti in ostankih za zdravila za uporabo v veterinarski medicini, ki so namenjena manjši uporabi ali uporabi pri manj pomembnih vrstah (EMEA/CVMP/SWP/66781/2005)9, in v povezavi z identičnimi zdravili se lahko karenca, določena za pomembnejše prežvekovalce, ekstrapolira na manj pomembne prežvekovalce, pri čemer se uporabi varnostni razpon 1,5, če obstaja možnost lokalnih ostankov.
Lower isolation index of E. coli in treated animals was observed.
Pri zdravljenih živalih so opazili manjši indeks izolacije E. coli.
The first time point where all residues were below the MRLs, in both studies, was 3 days post-treatment.
Prva časovna točka, ko so bile vse vrednosti ostankov pod MVO v obeh študijah, je bila 3 dni po zdravljenju.
In both studies the first time point at which residues in milk from all animals were below the MRL was 72 hours.
V obeh študijah je bila prva časovna točka, ko so bile vse vrednosti ostankov v mleku pod MVO, 72 ur.