natgillin/translations-raw huggingface dataset:
These terms will apply to all age ranges and physiological status, as well as for both meat and/or milk production animals.
Ti pogoji bodo veljali za vse starostne razpone in fiziološka stanja ter za živali, namenjene proizvodnji mesa in/ali mleka.
Regarding the ‘septicaemia' indication, this was present in the experimental study only.
Indikacija »septikemije« je bila vključena samo v eksperimentalno študijo.
Smarjeska cesta 6
Šmarješka cesta 6
Furthermore, it has to be considered that large differences exist in the pharmacokinetic behaviour of enrofloxacin among different species, which additionally will influence the decision about the correct dosage of “product name (to be completed nationally)”.
Poleg tega je treba upoštevati, da med različnimi vrstami obstajajo velike razlike v farmakokinetiki enrofloksacina, ki bodo prav tako vplivale na odločitev glede ustreznega odmerka zdravila „ime zdravila (izpolni država)“.
The withdrawal periods should be amended as proposed to provide assurance for consumer safety.
Karence je treba spremeniti, kot je predlagano, da se zagotovi varnost potrošnikov.
However, clinical efficacy of the recommended dose for respiratory infection has not been demonstrated.
Vendar pa klinične učinkovitosti priporočenega odmerka proti okužbi dihal niso pokazali.
The highest success rate was observed in calves ≤ 2 years old (71.4%), but it decreased in older animals.
Največji delež uspešnosti so opazili pri teletih, starih ≤ 2 let (71,4 %), pri starejših živalih pa je bil ta delež manjši.
Burgos Spain
Burgos Španija
- A study, conducted in intensive rabbit farms in Spain, has demonstrated a high prevalence of Staph.
- Študija, izvedena na intenzivnih kunčjih farmah v Španiji, je pokazala veliko prevalenco sevov Staph.
Rabbits are raised in continuous systems where resistant bacteria might be persistent over time, however the overall risk would remain low due to the low consumption of rabbit meat.
Kunci so gojeni v neprekinjenih sistemih, v katerih lahko odporne bakterije sčasoma postanejo persistentne, vendar bi splošno tveganje ostalo majhno zaradi majhne potrošnje kunčjega mesa.
aureus strains were isolated from commercial rabbit farms in different Member States and tested for resistance.
aureus, izoliranih iz komercialnih kunčjih farm v različnih državah članicah, testirali glede odpornosti.
The indications assessed are considered to be aligned with the principles of responsible use of fluoroquinolones in animals.
Ocenjene indikacije so usklajene z načeli preudarne uporabe fluorokinolonov pri živalih.
The results of different well controlled studies with natural enteric infection were reviewed.
Pregledali so rezultate različnih, dobro nadzorovanih študij z naravno enterično okužbo.
Several controlled experimental studies were conducted with induced infection (all of them together with M. haemolytica).
Opravili so več nadzorovanih eksperimentalnih študij s sproženo okužbo (vse skupaj z M. haemolytica).
Further to the assessment of the available data several contraindications and warning sentences are recommended to ensure the safe use of the products.
Poleg ocene razpoložljivih podatkov so določili več kontraindikacij ter opozorilnih stavkov, s katerimi se bo zagotovila varna uporaba teh zdravil.
These extrapolations were considered acceptable as goats are considered as minor species.
Te ekstrapolacije so bile sprejemljive, saj so koze manj pomembna živalska vrsta.
At the European level, different actions and activities are constantly taken in order to maintain the efficacy of fluoroquinolone-containing veterinary medicinal products.
Na evropski ravni se nenehno izvajajo različni ukrepi in dejavnosti, s katerimi se vzdržuje učinkovitost zdravil za uporabo v veterinarski medicini, ki vsebujejo fluorokinolone.
Although limited data were available the percentage of resistance of Staph.
Čeprav so na voljo omejeni podatki, je bil delež odpornosti Staph.
As regards to Mycoplasma bovis, this microorganism is difficult to be identified and assessed since it is often involved in mixed infections.
Mikroorganizem Mycoplasma bovis je težko določiti in oceniti, saj je pogosto vključen pri mešanih okužbah.
Repeated injections should be made at different injection sites.
Pri večkratnem injiciranju je treba injekcije dati na različna mesta.
Fluoroquinolones represent a class of antimicrobials which is critically important in the treatment of severe and invasive infections in humans and animals and are therefore of special interest for public and animal health.
Fluorokinoloni spadajo v razred antibiotikov, ki so kritično pomembni za zdravljenje hudih in invazivnih okužb pri ljudeh ter živalih, zato imajo še posebej pomembno vlogo v javnem zdravju in zdravju živali.
Do not use in growing horses because of possible deleterious damage on articular cartilage.
Ne uporabljajte pri rastočih konjih, saj obstaja možnost škodljivih učinkov na sklepni hrustanec.
The withdrawal period was derived from the first study, but also bearing in mind the results of the second (confirmatory) study.
Karenco so izpeljali iz prve študije upoštevajoč tudi rezultate iz druge (potrditvene) študije.
In another study the efficacy against Staph.
V drugi študiji so proučevali učinkovitost proti Staph.
Clinical and bacteriological cure were obtained.
Prišlo je do klinične in bakteriološke ozdravitve.
in the last years: bovine: 45 to 86%; porcine: 4% to 27%.
proti ciprofloksacinu: govedo: 45 do 86 %, prašiči: 4 do 27 %.
Moreover, the excessive volume of injection needed with the 50 mg/ml strength could lead to violation of allowed residues.
Poleg tega bi lahko čezmerna prostornina injekcije, potrebne za jakost 50 mg/ml, povzročila preveliko vrednost dovoljenih ostankov.
Therefore, the veterinarian must be aware of the correct temperature requirements of the respective reptile species and the hydration status of the individual patient.
Veterinar mora zato poznati zahteve glede ustrezne temperature za zadevno vrsto plazilcev in stanje hidracije pri posamezni živali.
The respiratory indications were extrapolated from the ones existing in cattle.
Indikacije za dihala so bile ekstrapolirane na podlagi obstoječih indikacij za govedo.
949 01, Nitra Slovakia
949 01, Nitra Slovaška
For some serious animal indications, fluoroquinolones could be the only alternative available (EMEA/CVMP/SAGAM/184651/2005)7.
Pri nekaterih resnih indikacijah pri živalih so lahko fluorokinoloni edina razpoložljiva možnost (EMEA/CVMP/SAGAM/184651/2005)7.
Following intravenous injection:
Po intravenskem injiciranju:
48308 Senden-Bösensell Germany
48308 Senden-Bösensell Nemčija
and Actinobacillus pleuropneumoniae.
in Actinobacillus pleuropneumoniae.
Add, to all products: CONTRAINDICATIONS
Dodajte vsem zdravilom: KONTRAINDIKACIJE
The following information addressing the concern of the risk to public health (consumers and handlers) due to the potential for selection of antibiotic resistant strains of Staph.
Spodnje informacije obravnavajo zadržek glede tveganja za javno zdravje (za potrošnike in rejce) zaradi potenciala za selekcijo na antibiotike odpornih sevov Staph.
The Committee is aware that (i) the use of enrofloxacin in rabbit production could lead to an increase in Staph.
Odbor se zaveda, da (i) lahko uporaba enrofloksacina v proizvodnji kuncev povzroči povečano odpornost Staph.
In the 100 mg/ml strength, this indication should be restricted to cattle less than 2 years old.
Pri jakosti 100 mg/ml je treba to indikacijo omejiti na teleta, mlajša od 2 let.
LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
Romunija LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
Thus, it was considered that for consistency the target animal species for both strengths should harmonised to “Sheep” and “Goats”.
Posledično je odbor menil, naj se ciljne živalske vrste za obe jakosti uskladijo na »ovce« in »koze«.
D-59387 Ascheberg
D-59387 Ascheberg Nemčija
Metabolism of substances and activity of the immune system are, thus, critically dependent on the body temperature.
Presnova snovi in delovanje imunskega sistema sta tako močno odvisna od telesne temperature.
Antimicrobial resistance in target pathogens
Protimikrobna odpornost pri ciljnih patogenih
The success rate was 76% on day 3 and 50% on day 10 in the test group versus 14.3% and 9.5%, respectively, for the same days, for the reference product.
Delež uspešnosti v preiskovani skupini je bil 76-odstoten na 3. dan in 50-odstoten na 10. dan v primerjavi s 14,3- oziroma 9,5-odstotnim deležem na ista dneva pri referenčnem zdravilu.
Reptiles are ectothermic, relying on external heat sources to maintain their body temperature at the optimum level for correct function of all body systems.
Plazilci so ektotermne živali, ki potrebujejo zunanje vire toplote za vzdrževanje optimalne telesne temperature, ki zagotavlja pravilno delovanje vseh telesnih sistemov.
2065m 06516 Carros Cedex France
2065m 06516 Carros Cedex Francija
All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Vsi mehanizmi povzročajo zmanjšano občutljivost bakterij za fluorokinolone.
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.
Rezultati teh preskušanj so pokazali dobro klinično evolucijo živali pri preiskovanih odmerkih, vendar pa mikrobiološki rezultati niso bili predloženi oziroma so kazali na nepopolno izločanje patogena.
S.C. ROMVAC COMPANY S.A. Şos.
Romunija S.C. ROMVAC COMPANY S.A. Şos.
aureus strains, 17.2% of which were found to be methicillin-resistant4.
aureus, od katerih jih je bilo 17,2 % odpornih proti meticilinu4.
Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia
Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenija
It is not clear whether quinolone resistant Campylobacter infection is associated with adverse human health consequences.
Ni jasno, ali je okužba s Campylobacter, odporna na kinolone, povezana z neželenimi posledicami za zdravje ljudi.
Therefore the CVMP recommended the removal of the target pathogen Histophilus somni from the product information.
Odbor CVMP je zato priporočil izbris ciljnega patogena Histophilus somni iz informacij o zdravilu.
The results from the pharmacokinetic/pharmacodynamic (PK/PD) analysis with M. haemolytica were not fully predictive of clinical efficacy.
Rezultati farmakokinetične/farmakodinamične (FK/FD) analize za M. haemolytica niso popolnoma napovedni glede klinične učinkovitosti.
D-88326 Aulendorf Germany
D-88326 Aulendorf Nemčija
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.
Zaradi prisotnosti renalno-portalnega sistema pri plazilcih je primerno, da se zdravila dajejo v sprednjo polovico telesa, kadar je to mogoče.
Add, to all products: ADVICE ON CORRECT ADMINISTRATION
Dodajte vsem zdravilom: NASVET O PRAVILNI UPORABI ZDRAVILA
105b D-06406 Bernburg
105b D-06406 Bernburg Nemčija
Regarding Histophilus somni, only susceptibility data originated in Canada, USA and Europe were provided, showing the high susceptibility of the bacterium to enrofloxacin.
Za Histophilus somni so bili predloženi samo podatki o občutljivosti, ki so izvirali iz Kanade, ZDA in Evrope, pokazali pa so veliko občutljivost te bakterije za enrofloksacin.
An extension of the treatment interval to 48 hours may be necessary in individual cases.
V posameznih primerih je treba časovni presledek med odmerki podaljšati na 48 ur.
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.
Odbor je menil, da so ciljne vrste in z njimi povezane indikacije ter odmerjanje sprejemljivi, saj so vse te vrste manj pomembne vrste in v državah članicah, v katerih so te ciljne živalske vrste odobrene, niso poročali o nobenih težavah z varnostjo ali učinkovitostjo.
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.
Karenco so izračunali statistično s pomočjo metode TTSC (tj. ko vrednost ostankov pri vseh živalih pade pod varno mejo v časovnem razponu, za katerega so na voljo podatki), kar je pomenilo 5,6 molž/3 dni.
aureus LAMRSA (ST398, spa types t034 and t5210) occurring in rabbits raised intensively for meat production and involving farm workers or their family members5.
aureus LA-MRSA (ST398, vrsti t034 ter t5210), ki se pojavlja pri kuncih, intenzivno gojenih za proizvodnjo mesa, in vključuje delavce na farmi ali njihove družinske člane5.
aureus isolates originating from rabbits is relatively rare compared to resistance in Staph.
aureus, ki izvirajo iz kuncev, precej redka v primerjavi z odpornostjo izolatov Staph.
The bacteriological success was the first criteria of efficacy.
Prvo merilo učinkovitosti je bila bakteriološka uspešnost.
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.
Učinkovitost proti M. haemolytica in Mycoplasma bovis je bila dokazana v več eksperimentalnih študijah, v katerih so sprožili okužbo z M. haemolytica in M. bovis.
Data regarding Pasteurella spp.
Podatki o Pasteurella spp.
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.
Odbor CVMP je zato menil, da so te indikacije sprejemljive za pse in mačke, če se upošteva, da so predloženi FK/FD podatki teoretično napovedni za dobro klinično učinkovitost pri zdravljenju bakterijskih okužb, za katere so zdravila indicirana, in da je učinkovitost zdravil več kot dve desetletji potrjena s terenskimi študijami ter dobrimi kliničnimi izkušnjami.
In pigs, the injection should be made in the neck at the ear base.
Pri prašičih je treba injekcijo dati v vrat ob korenu ušesa.
In addition, a PK/PD analysis was conducted with this pathogen, obtaining values considered as predictive of clinical efficacy.
Poleg tega so opravili FK/FD analizo s tem patogenom, s katero so pridobili vrednosti, ki so napovedne za klinično učinkovitost.
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.
Na podlagi dobljenih rezultatov ni bilo mogoče potrditi, ali je manjši odmerek (2,5 mg/kg telesne mase) povzročil ozdravitev ali izboljšanje pri živalih.
Cattle (intravenous)
Govedo (intravensko)
Milk: 3 days.
Mleko: 3 dni.
In the case of Actinobacillus pleuropneumoniae several references were reviewed with experimental and field studies conducted in piglets and pigs.
Za Actinobacillus pleuropneumoniae so bile pregledane mnoge reference iz eksperimentalnih in terenskih študij, izvedenih na pujskih in prašičih.
Prahova Romania
Prahova Romunija
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.
Ozdravitev ali izboljšanje so opazili pri od 85 do 90 % živalih, zdravljenih z enrofloksacinom, rezultati pa so bili najboljši pri parenteralni uporabi, ki ji je sledila peroralna uporaba.
A positive control group treated with oxytetracyclin and an untreated group were included.
Vključili so pozitivno kontrolno skupino, zdravljeno z oksitetraciklinom, in nezdravljeno skupino.
The 2012 RESAPATH annual report indicated that more than 90% of Pasteurella in goats are sensitive to enrofloxacin.
Letno poročilo 2012 RESAPATH je pokazalo, da je več kot 90 % primerov okužbe s Pasteurella pri kozah občutljivih na enrofloksacin.
The study results indicate that the pharmacokinetics of enrofloxacin did not differ significantly between sheep and goats.
Rezultati študije kažejo, da se farmakokinetika enrofloksacina med ovcami in kozami ni pomembno razlikovala.
Dto 2775-696 Carcavelos Portugal
Dto 2775-696 Carcavelos Portugalska
2794-044 Carnaxide Portugal
2794-044 Carnaxide Portugalska
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).
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).
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.
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.
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.
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.
Romikim Farma SL Gran Via Carlos III, 98,6 8027 Barcelona Spain
Nizozemska Romikim Farma SL Gran Via Carlos III, 98,6 8027 Barcelona
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.
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.
Dose determination and dose confirmation studies demonstrated the efficacy of the recommended dose.
Študije za določanje in potrditev odmerka so pokazale učinkovitost priporočenega odmerka.
All residues were below the MRL on the 4th milking (48 hours).
Vse vrednosti so bile pod MVO ob 4. molži (po 48 urah).
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.
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.
In complicated infections, higher dosages and longer treatment courses may be necessary.
Pri zapletenih okužbah bodo morda potrebni večji odmerki in daljše zdravljenje.
Add, to all products:
Dodajte vsem zdravilom:
The remaining indications i.e. mastitis, alimentary tract infections and septicaemia were extrapolated from sheep.
Preostale indikacije, tj. mastitis, okužbe prebavil in septikemija, so bile ekstrapolirane iz podatkov za ovce.
Better clinical results were observed in 3-4 weeks old animals compared to 1-2 weeks old animals.
Pri živalih, starih od 3 do 4 tedne, so opazili boljše rezultate kot pri živalih, starih od 1 do 2 tedna.
A field study showed the efficacy of the proposed dose comparing it with a reference product containing cefquinome.
Terenska študija je pokazala učinkovitost predlaganega odmerka v primerjavi z referenčnim zdravilom, ki je vsebovalo cefkvinom.
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.
Poleg tega so učinkovitost dokazali v več študijah, izvedenih v ZDA z argininsko formulacijo enrofloksacina v odmerku 7,5 mg/kg telesne mase.
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.
Študijo so izvedli samo z 12 živalmi, zato statistične analize8 podatkov ni bilo mogoče opraviti in so karenco izpeljali z alternativnim pristopom.
The presence of bacteria including E. coli was determined.
Ugotovili so prisotnost bakterij, vključno z E. coli.
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.
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.
In support of the efficacy data, published literature was provided, but, generally, lacking specific data and employing variable posology regimens.
Kot podpora za podatke o učinkovitosti je bila predložena objavljena literatura, vendar je na splošno vsebovala pomanjkljive specifične podatke in spremenljive režime odmerjanja.
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.
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.
In the milk samples the pathogens Staph.
V vzorcih mleka so ugotovili patogena Staph.
GENERA Slovenia d.o.o.
Slovenija GENERA Slovenia d.o.o.
Milk: 4 days.
Mleko: 4 dni.
- 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.
- 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).
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.
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.
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.
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.
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.
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.