FrancophonIA/ELRC3.0 huggingface dataset:
English: No data from other European countries/regions have been submitted, so it could not been evaluated if this situation is representative of the whole EU.
Slovenian: Predloženi niso bili nobeni podatki iz drugih evropskih držav/območij, zato ni bilo mogoče oceniti, ali te okoliščine veljajo za celotno EU.
English: This might potentially lead to problems of animal welfare.
Slovenian: To lahko privede do težav z dobrobitjo živali.
English: Types and mechanisms of resistance
Slovenian: Vrste in mehanizmi odpornosti
English: are also appropriate for Grampositive infection in both species as well.
Slovenian: so prav tako primerna za grampozitivno okužbo pri obeh vrstah.
English: The clinical response rate was 92%.
Slovenian: Delež kliničnega odziva je bil 92-odstoten.
English: Data were available from two studies.
Slovenian: Na voljo so podatki iz dveh študij.
English: aureus isolates originating from other animals and humans.
Slovenian: aureus, ki izvirajo iz drugih živali ter ljudi.
English: These data come from different bibliographic publications as well as publicly available reports from European monitoring programs and cover the period between 1998 and 2009.
Slovenian: Ti podatki izhajajo iz različnih bibliografskih publikacij in javno dostopnih poročil iz evropskih programov spremljanja za obdobje med letoma 1998 ter 2009.
English: No mortality was observed in the treatment groups.
Slovenian: V zdravljenih skupinah niso opazili umrljivosti.
English: Several publications and proprietary studies were reviewed.
Slovenian: Pregledali so več publikacij in lastniških študij.
English: 1123 Budapest Hungary
Slovenian: 1123 Budapest
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.
Slovenian: Čeprav znanstvena utemeljitev za to indikacijo ni trdna, kot bi želeli, so klinično ozdravitev (odziv na zdravljenje) dosegli pri 87,5 % okužb, ki vključujejo Staph.
English: Neither was appropriate for analysis using the statistical method.
Slovenian: Nobena ni bila primerna za analizo s statistično metodo.
English: Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
Slovenian: Romunija PASTEUR Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
English: 21 Montee De La Garde 69340 Francheville France
Slovenian: 21 Montee De La Garde 69340 Francheville Francija
English: Do not use in birds intended for human consumption.
Slovenian: Ne uporabljajte pri pticah, namenjenih za prehrano ljudi.
English: Therefore, the recommendations made here can only be used as a starting point for individual dose setting.
Slovenian: Priporočila v tem povzetku lahko zato služijo zgolj kot izhodišče za določitev odmerka za posamezno žival.
English: The term ‘young stock' should be replaced with ‘Cattle (calves)'.
Slovenian: Izraz „mlada živina“ je treba nadomestiti z izrazom „govedo (teleta)“.
English: Add, to all products and delete the existing text: 5.1 Pharmacodynamic properties
Slovenian: Dodajte vsem zdravilom in izbrišite obstoječe besedilo: 5.1 Farmakodinamične lastnosti
English: ESTEVE FARMA, LDA Av. Do Forte, 3
Slovenian: Portugalska ESTEVE FARMA, LDA Av. Do Forte, 3
English: The risk on individual level might be increased for rabbit as compared to other species.
Slovenian: Tveganje na individualni stopnji je lahko pri kuncih povečano v primerjavi z drugimi vrstami.
English: Via Emilia, 285 Ozzano Emilia (BO) Italy
Slovenian: Via Emilia, 285 Ozzano Emilia (BO) Italija
English: In other cases, a combination of parenteral and oral administration or the parenteral route alone was used.
Slovenian: V drugih primerih so uporabili kombinacijo parenteralnega in peroralnega odmerjanja ali samo parenteralno odmerjanje.
English: Special warnings and precautions
Slovenian: Posebna opozorila in previdnostni ukrepi
English: The results from an experimental study and a field study were provided.
Slovenian: Predloženi so bili rezultati iz eksperimentalne študije in terenske študije.
English: 20037 Paderno Dugnano (MI) Italy
Slovenian: 20037 Paderno Dugnano (MI) Italija
English: Bayer Hungária Kft. Alkotás u. 50.
Slovenian: Madžarska Bayer Hungária Kft. Alkotás u. 50.
English: - In another study 56 Staph.
Slovenian: - V drugi študiji so 56 sevov Staph.
English: An untreated group was included.
Slovenian: Vključili so nezdravljeno skupino.
English: Antibacterial spectrum
Slovenian: Protibakterijski spekter
English: Friulchem via San Marco, 23 33099 Vivaro (PN) Italy
Slovenian: Friulchem via San Marco, 23 33099 Vivaro (PN) Italija
English: The provided data on efficacy are adequate to demonstrate efficacy against this bacteria.
Slovenian: Predloženi podatki o učinkovitosti so zadostni za potrditev učinkovitosti proti tej bakteriji.
English: 8501 Novo Mesto Slovenia
Slovenian: 8501 Novo mesto Slovenija
English: The percentage of bacteriological cure (Staph.
Slovenian: Odstotek bakteriološke ozdravitve (Staph.
English: The study also unveiled very high resistance to quinolones (around 38% for ciprofloxacin).
Slovenian: Študija je prav tako pokazala zelo veliko odpornost proti kinolonom (približno 38-odstotno proti ciprofloksacinu).
English: No field studies were submitted to support the indications in goats.
Slovenian: Predložene niso bile nobene terenske študije, ki bi podprle indikacije pri kozah.
English: 3641 RT Mijdrecht Netherlands
Slovenian: 3641 RT Mijdrecht Nizozemska
English: Using the alternative approach8 this represents an unusually high safety span in relation to the data generated with the recommended dose but a reasonable safety span (20%) in relation to the lower dose study.
Slovenian: Pri uporabi alternativnega pristopa8 to predstavlja nenavadno velik varnostni razpon glede na podatke, pridobljene s priporočenim odmerkom, toda razumen varnostni razpon (20 %) v povezavi s študijo z manjšim odmerkom.
English: These terms will apply to all age ranges and physiological status, as well as for both meat and/or milk production animals.
Slovenian: Ti pogoji bodo veljali za vse starostne razpone in fiziološka stanja ter za živali, namenjene proizvodnji mesa in/ali mleka.
English: Regarding the ‘septicaemia' indication, this was present in the experimental study only.
Slovenian: Indikacija »septikemije« je bila vključena samo v eksperimentalno študijo.
English: Smarjeska cesta 6
Slovenian: Šmarješka cesta 6
English: 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)”.
Slovenian: 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)“.
English: The withdrawal periods should be amended as proposed to provide assurance for consumer safety.
Slovenian: Karence je treba spremeniti, kot je predlagano, da se zagotovi varnost potrošnikov.
English: However, clinical efficacy of the recommended dose for respiratory infection has not been demonstrated.
Slovenian: Vendar pa klinične učinkovitosti priporočenega odmerka proti okužbi dihal niso pokazali.
English: The highest success rate was observed in calves ≤ 2 years old (71.4%), but it decreased in older animals.
Slovenian: Največji delež uspešnosti so opazili pri teletih, starih ≤ 2 let (71,4 %), pri starejših živalih pa je bil ta delež manjši.
English: Burgos Spain
Slovenian: Burgos Španija
English: - A study, conducted in intensive rabbit farms in Spain, has demonstrated a high prevalence of Staph.
Slovenian: - Študija, izvedena na intenzivnih kunčjih farmah v Španiji, je pokazala veliko prevalenco sevov Staph.
English: 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.
Slovenian: 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.
English: aureus strains were isolated from commercial rabbit farms in different Member States and tested for resistance.
Slovenian: aureus, izoliranih iz komercialnih kunčjih farm v različnih državah članicah, testirali glede odpornosti.
English: The indications assessed are considered to be aligned with the principles of responsible use of fluoroquinolones in animals.
Slovenian: Ocenjene indikacije so usklajene z načeli preudarne uporabe fluorokinolonov pri živalih.
English: The results of different well controlled studies with natural enteric infection were reviewed.
Slovenian: Pregledali so rezultate različnih, dobro nadzorovanih študij z naravno enterično okužbo.
English: Several controlled experimental studies were conducted with induced infection (all of them together with M. haemolytica).
Slovenian: Opravili so več nadzorovanih eksperimentalnih študij s sproženo okužbo (vse skupaj z M. haemolytica).
English: Further to the assessment of the available data several contraindications and warning sentences are recommended to ensure the safe use of the products.
Slovenian: Poleg ocene razpoložljivih podatkov so določili več kontraindikacij ter opozorilnih stavkov, s katerimi se bo zagotovila varna uporaba teh zdravil.
English: These extrapolations were considered acceptable as goats are considered as minor species.
Slovenian: Te ekstrapolacije so bile sprejemljive, saj so koze manj pomembna živalska vrsta.
English: At the European level, different actions and activities are constantly taken in order to maintain the efficacy of fluoroquinolone-containing veterinary medicinal products.
Slovenian: Na evropski ravni se nenehno izvajajo različni ukrepi in dejavnosti, s katerimi se vzdržuje učinkovitost zdravil za uporabo v veterinarski medicini, ki vsebujejo fluorokinolone.
English: Although limited data were available the percentage of resistance of Staph.
Slovenian: Čeprav so na voljo omejeni podatki, je bil delež odpornosti Staph.
English: As regards to Mycoplasma bovis, this microorganism is difficult to be identified and assessed since it is often involved in mixed infections.
Slovenian: Mikroorganizem Mycoplasma bovis je težko določiti in oceniti, saj je pogosto vključen pri mešanih okužbah.
English: Repeated injections should be made at different injection sites.
Slovenian: Pri večkratnem injiciranju je treba injekcije dati na različna mesta.
English: 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.
Slovenian: 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.
English: Do not use in growing horses because of possible deleterious damage on articular cartilage.
Slovenian: Ne uporabljajte pri rastočih konjih, saj obstaja možnost škodljivih učinkov na sklepni hrustanec.
English: The withdrawal period was derived from the first study, but also bearing in mind the results of the second (confirmatory) study.
Slovenian: Karenco so izpeljali iz prve študije upoštevajoč tudi rezultate iz druge (potrditvene) študije.
English: In another study the efficacy against Staph.
Slovenian: V drugi študiji so proučevali učinkovitost proti Staph.
English: Clinical and bacteriological cure were obtained.
Slovenian: Prišlo je do klinične in bakteriološke ozdravitve.
English: in the last years: bovine: 45 to 86%; porcine: 4% to 27%.
Slovenian: proti ciprofloksacinu: govedo: 45 do 86 %, prašiči: 4 do 27 %.
English: Moreover, the excessive volume of injection needed with the 50 mg/ml strength could lead to violation of allowed residues.
Slovenian: Poleg tega bi lahko čezmerna prostornina injekcije, potrebne za jakost 50 mg/ml, povzročila preveliko vrednost dovoljenih ostankov.
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.
Slovenian: Veterinar mora zato poznati zahteve glede ustrezne temperature za zadevno vrsto plazilcev in stanje hidracije pri posamezni živali.
English: The respiratory indications were extrapolated from the ones existing in cattle.
Slovenian: Indikacije za dihala so bile ekstrapolirane na podlagi obstoječih indikacij za govedo.
English: 949 01, Nitra Slovakia
Slovenian: 949 01, Nitra Slovaška
English: For some serious animal indications, fluoroquinolones could be the only alternative available (EMEA/CVMP/SAGAM/184651/2005)7.
Slovenian: Pri nekaterih resnih indikacijah pri živalih so lahko fluorokinoloni edina razpoložljiva možnost (EMEA/CVMP/SAGAM/184651/2005)7.
English: Following intravenous injection:
Slovenian: Po intravenskem injiciranju:
English: 48308 Senden-Bösensell Germany
Slovenian: 48308 Senden-Bösensell Nemčija
English: and Actinobacillus pleuropneumoniae.
Slovenian: in Actinobacillus pleuropneumoniae.
English: Add, to all products: CONTRAINDICATIONS
Slovenian: Dodajte vsem zdravilom: KONTRAINDIKACIJE
English: 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.
Slovenian: Spodnje informacije obravnavajo zadržek glede tveganja za javno zdravje (za potrošnike in rejce) zaradi potenciala za selekcijo na antibiotike odpornih sevov Staph.
English: The Committee is aware that (i) the use of enrofloxacin in rabbit production could lead to an increase in Staph.
Slovenian: Odbor se zaveda, da (i) lahko uporaba enrofloksacina v proizvodnji kuncev povzroči povečano odpornost Staph.
English: B-2322 Hoogstraaten Belgium
Slovenian: B-2322 Hoogstraaten Belgija
English: In the 100 mg/ml strength, this indication should be restricted to cattle less than 2 years old.
Slovenian: Pri jakosti 100 mg/ml je treba to indikacijo omejiti na teleta, mlajša od 2 let.
English: LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
Slovenian: Romunija LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
English: Thus, it was considered that for consistency the target animal species for both strengths should harmonised to “Sheep” and “Goats”.
Slovenian: Posledično je odbor menil, naj se ciljne živalske vrste za obe jakosti uskladijo na »ovce« in »koze«.
English: D-59387 Ascheberg
Slovenian: D-59387 Ascheberg Nemčija
English: Metabolism of substances and activity of the immune system are, thus, critically dependent on the body temperature.
Slovenian: Presnova snovi in delovanje imunskega sistema sta tako močno odvisna od telesne temperature.
English: Antimicrobial resistance in target pathogens
Slovenian: Protimikrobna odpornost pri ciljnih patogenih
English: 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.
Slovenian: 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.
English: Reptiles are ectothermic, relying on external heat sources to maintain their body temperature at the optimum level for correct function of all body systems.
Slovenian: Plazilci so ektotermne živali, ki potrebujejo zunanje vire toplote za vzdrževanje optimalne telesne temperature, ki zagotavlja pravilno delovanje vseh telesnih sistemov.
English: 2065m 06516 Carros Cedex France
Slovenian: 2065m 06516 Carros Cedex Francija
English: All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Slovenian: Vsi mehanizmi povzročajo zmanjšano občutljivost bakterij za fluorokinolone.
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.
Slovenian: 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.
English: S.C. ROMVAC COMPANY S.A. Şos.
Slovenian: Romunija S.C. ROMVAC COMPANY S.A. Şos.
English: aureus strains, 17.2% of which were found to be methicillin-resistant4.
Slovenian: aureus, od katerih jih je bilo 17,2 % odpornih proti meticilinu4.
English: Bayer SpA Viale Certosa, 130 20156 Milano Italy
Slovenian: Bayer SpA Viale Certosa, 130 20156 Milano Italija
English: Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia
Slovenian: Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenija
English: It is not clear whether quinolone resistant Campylobacter infection is associated with adverse human health consequences.
Slovenian: Ni jasno, ali je okužba s Campylobacter, odporna na kinolone, povezana z neželenimi posledicami za zdravje ljudi.
English: Therefore the CVMP recommended the removal of the target pathogen Histophilus somni from the product information.
Slovenian: Odbor CVMP je zato priporočil izbris ciljnega patogena Histophilus somni iz informacij o zdravilu.
English: The results from the pharmacokinetic/pharmacodynamic (PK/PD) analysis with M. haemolytica were not fully predictive of clinical efficacy.
Slovenian: Rezultati farmakokinetične/farmakodinamične (FK/FD) analize za M. haemolytica niso popolnoma napovedni glede klinične učinkovitosti.
English: D-88326 Aulendorf Germany
Slovenian: D-88326 Aulendorf Nemčija
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.
Slovenian: Zaradi prisotnosti renalno-portalnega sistema pri plazilcih je primerno, da se zdravila dajejo v sprednjo polovico telesa, kadar je to mogoče.
English: Add, to all products: ADVICE ON CORRECT ADMINISTRATION
Slovenian: Dodajte vsem zdravilom: NASVET O PRAVILNI UPORABI ZDRAVILA
English: 105b D-06406 Bernburg
Slovenian: 105b D-06406 Bernburg Nemčija
English: Regarding Histophilus somni, only susceptibility data originated in Canada, USA and Europe were provided, showing the high susceptibility of the bacterium to enrofloxacin.
Slovenian: 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.
English: An extension of the treatment interval to 48 hours may be necessary in individual cases.
Slovenian: V posameznih primerih je treba časovni presledek med odmerki podaljšati na 48 ur.
English: 05-651 Drwalew Poland
Slovenian: 05-651 Drwalew Poljska
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.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: aureus isolates originating from rabbits is relatively rare compared to resistance in Staph.
Slovenian: aureus, ki izvirajo iz kuncev, precej redka v primerjavi z odpornostjo izolatov Staph.
English: The bacteriological success was the first criteria of efficacy.
Slovenian: Prvo merilo učinkovitosti je bila bakteriološka uspešnost.
English: The efficacy against M. haemolytica and Mycoplasma bovis has been justified with several experimental studies in which induced infection with M. haemolytica and M. bovis was produced.
Slovenian: 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.
English: Data regarding Pasteurella spp.
Slovenian: Podatki o Pasteurella spp.
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.
Slovenian: 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.
English: In pigs, the injection should be made in the neck at the ear base.
Slovenian: Pri prašičih je treba injekcijo dati v vrat ob korenu ušesa.
English: In addition, a PK/PD analysis was conducted with this pathogen, obtaining values considered as predictive of clinical efficacy.
Slovenian: Poleg tega so opravili FK/FD analizo s tem patogenom, s katero so pridobili vrednosti, ki so napovedne za klinično učinkovitost.
English: From the results obtained, it was not possible to confirm whether the lower dose (2.5 mg/kg bw) produced cure or improvement in the animals.
Slovenian: Na podlagi dobljenih rezultatov ni bilo mogoče potrditi, ali je manjši odmerek (2,5 mg/kg telesne mase) povzročil ozdravitev ali izboljšanje pri živalih.
English: Cattle (intravenous)
Slovenian: Govedo (intravensko)
English: Milk: 3 days.
Slovenian: Mleko: 3 dni.
English: In the case of Actinobacillus pleuropneumoniae several references were reviewed with experimental and field studies conducted in piglets and pigs.
Slovenian: Za Actinobacillus pleuropneumoniae so bile pregledane mnoge reference iz eksperimentalnih in terenskih študij, izvedenih na pujskih in prašičih.
English: Prahova Romania
Slovenian: Prahova Romunija
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.
Slovenian: 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.
English: A positive control group treated with oxytetracyclin and an untreated group were included.
Slovenian: Vključili so pozitivno kontrolno skupino, zdravljeno z oksitetraciklinom, in nezdravljeno skupino.
English: The 2012 RESAPATH annual report indicated that more than 90% of Pasteurella in goats are sensitive to enrofloxacin.
Slovenian: Letno poročilo 2012 RESAPATH je pokazalo, da je več kot 90 % primerov okužbe s Pasteurella pri kozah občutljivih na enrofloksacin.
English: The study results indicate that the pharmacokinetics of enrofloxacin did not differ significantly between sheep and goats.
Slovenian: Rezultati študije kažejo, da se farmakokinetika enrofloksacina med ovcami in kozami ni pomembno razlikovala.
English: Dto 2775-696 Carcavelos Portugal
Slovenian: Dto 2775-696 Carcavelos Portugalska
English: 2794-044 Carnaxide Portugal
Slovenian: 2794-044 Carnaxide Portugalska