natgillin/translations-raw huggingface dataset:
Data collected from EU surveillance programmes showed that levels of resistance in E.coli to enrofloxacin varied from 0-47% depending on the EU Member State from which the isolates were sourced. 
Podatki, zbrani v programih nadzorovanja v EU, so pokazali, da je bil delež odpornosti E. coli proti enrofloksacinu od 0- do 47-odstoten, kar je bilo odvisno od države članice, iz katere so izolati izvirali.
Although there is some evidence of resistance development in Mycoplasma, these organisms are rarely included in surveillance schemes and evidence of widespread resistance in the EU or lack of efficacy of the dose is hard to find. 
Čeprav obstaja nekaj dokazov o razvoju odpornosti proti mikoplazmi, so ti organizmi redko vključeni v sheme nadzorovanja, dokaze o razširjeni odpornosti v EU ali odsotnosti učinkovitosti odmerjanja pa je težko najti.
Based on the Clinical Laboratory and Standards Institute (CLSI) resistance breakpoint of ≥2 µg/ml, one report shows that the upper range of MICs of M.synoviae increased further to 2/4 µg/ml in 2008 in The Netherlands with an 11.7% resistance noted. 
Upoštevajoč mejo odpornosti Inštituta za klinične in laboratorijske standarde (CLSI) ≥ 2 µg/ml je eno poročilo na Nizozemskem pokazalo, da se je zgornja meja MIK proti M. synoviae leta 2008 nadalje povečala na 2/4 µg/ml, pri čemer so opazili 11,7-odstotno odpornost.
However, from the data submitted it is not possible to determine an optimum dose rate to treat E.coli infection in chickens. 
Vendar iz predloženih podatkov ni mogoče določiti optimalnega odmerka za zdravljenje okužbe z E. coli pri piščancih.
5 European Food Safety Authority and European Centre for Disease Prevention and Control; The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010. 
5 Evropska agencija za varnost hrane in Evropski center za preprečevanje in obvladovanje bolezni; The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010.
In addition the CVMP concluded that there is insufficient data to optimise the dose regimen for treatment of Escherichia coli in chickens and/or turkeys. 
Poleg tega je odbor CVMP sklenil, da ni zadostnih podatkov, da bi lahko optimizirali režim odmerjanja za zdravljenje okužbe z bakterijo Escherichia coli pri piščancih in/ali puranih.
The method of antimicrobial administration via the drinking water increases the resistance selection pressure due to variability in intake and therefore pharmacokinetics across the population. 
Način uporabe protimikrobnih zdravil v vodi za pitje poveča selekcijski pritisk, povezan z odpornostjo, saj je vnos variabilen, kar povzroči raznoliko farmakokinetiko v populaciji.
Mycoplasma spp are rarely included in surveillance or monitoring schemes and evidence of widespread resistance in the EU or lack of efficacy of the dose in the treatment of mycoplasmosis is hard to find. 
Patogeni Mycoplasma spp so redko vključeni v sheme nadzorovanja ali spremljanja, dokaze o razširjeni odpornosti v EU ali pomanjkljivi učinkovitosti odmerka pri zdravljenju mikoplazmoze pa je težko najti.
Arciucha 2, 24-100 Puławy Poland 
Arciucha 2, 24-100 Puławy Poljska
Enrofloxacin is associated with a concentration-dependent bactericidal action and therefore AUC0-24h/MIC and Cmax/MIC ratios are considered indicators of efficacy. 
Enrofloksacin je povezan z od koncentracije odvisnim baktericidnim delovanjem, zato sta razmerji AUC0-24h/MIK in Cmax/MIK pokazatelja učinkovitosti.
Les Corts 23, 08028 Barcelona Spain 
Les Corts 23, 08028 Barcelona Španija
The United Kingdom also noted that the withdrawal periods for oral solutions containing enrofloxacin vary across Member States from 3-15 days for chickens and 3-13 days for turkeys, therefore on 18 October 2012, the United Kingdom presented to the European Medicines Agency a referral notification under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys. 
V Združenem kraljestvu so prav tako ugotovili, da so karence za peroralne raztopine, ki vsebujejo enrofloksacin, v državah članicah različne, od 3 do 15 dni pri piščancih in od 3 do 13 dni pri puranih, zato je Združeno kraljestvo 18. oktobra 2012 Evropski agenciji za zdravila predložilo priglasitev napotitvenega postopka iz člena 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in/ali puranom v vodo za pitje.
Isolates were from cases of respiratory tract infections or septicaemia of poultry. 
Izolate so pridobili iz primerov okužb dihal ali septikemije pri perutnini.
In a study from 2010 an experimental infection of E.coli did not acquire resistance from a preinoculated multi-resistant E.coli. 
V študiji iz leta 2010 eksperimentalna okužba z E. coli ni prevzela odpornosti predhodno inokulirane multirezistentne E. coli.
Do not use when resistance/ cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment. 
Ne uporabite, če je znano, da se v jati, ki jo nameravate zdraviti, pojavi odpornost/navzkrižna odpornost proti (fluoro)kinolonom.
The CLSI breakpoint of ≥2 mg/l was used. 
Uporabili so mejo CLSI ≥2 mg/l.
All products are aqueous solutions and contain a solubilising agent, such as potassium hydroxide or acetic acid, a preservative such as benzyl alcohol, and are made up to volume with water; thus there are no indications that formulation differences can account for the variability seen between the studies provided. 
Vsa zdravila so vodne raztopine in vsebujejo topila, kot je kalijev hidroksid ali ocetna kislina, konzervanse, kot je benzilalkohol, ter so do končne prostornine zapolnjena z vodo, zato ni nobenih znakov, da bi lahko razlike v formulacijah povzročile variabilnost, ki so jo opazili med predloženimi študijami.
The active metabolite of enrofloxacin, ciprofloxacin, is categorised as a critically important antibiotic for use in human medicine. 
Aktivni presnovek enrofloksacina, ciprofloksacin, je razvrščen kot izjemno pomemben antibiotik za uporabo v humani medicini.
22603 Loudeac Cedex France 
22603 Loudeac Cedex Francija
Many of the studies submitted did not conform to current guidance, in that some MAHs provided only summaries of the data that they hold, and did not provide the details of the analytical method(s) used, the method validation data, nor data to demonstrate the stability of the analytes in the various matrices during storage between sampling and analysis, or during sample processing. 
Mnoge predložene študije niso bile skladne s trenutnimi smernicami, saj so imetniki dovoljenj za promet z zdravilom predložili samo povzetke svojih podatkov, niso pa vključili podrobnosti glede uporabljene(ih) analitične(ih) metode (metod), podatkov za validacijo metode (metod) in podatkov, s katerimi bi pokazali stabilnost analitov v različnih matriksih med shranjevanjem od vzorčenja do analize ali med obdelavo vzorcev.
They show that 10 mg/kg bw enrofloxacin was efficacious in reducing mortality and morbidity and that there was reduction in pathogen re-isolation for up to 4 weeks after inoculation. 
Pokazali so, da je bil odmerek enrofloksacina 10 mg/kg telesne mase učinkovit pri zmanjševanju umrljivosti ter obolevnosti in da je prišlo do zmanjšanja ponovne izolacije patogena do 4 tedne po inokulaciji.
Applicant/marketing authorisation holder 
Predlagatelj/imetnik dovoljenja za promet z zdravilom
1ere Avenue 2065 M L I D 06516 Carros Cedex Spain 
1ere Avenue 2065 M L I D 06516 Carros Cedex Španija
• The method of administration; some studies used gavage administration (which improves the accuracy of the dose, but also (potentially) affects the metabolic profile of the substance, since this is in effect a bolus dose, rather than a continuous dose), some studies used drinking water administration, as specified in the SPCs (which could lead to more variable results due to some birds drinking more medicated water than others, but is more representative of what would happen ‘in the field'); 
• način uporabe; nekatere študije so uporabile gavažo (ki izboljša natančnost odmerjanja, vendar prav tako (morda) vpliva na presnovni profil učinkovine, saj omogoča učinek bolusnega odmerjanja in ne neprekinjenega odmerjanja), nekatere študije so uporabile dajanje zdravila v vodo za pitje, kot je navedeno v povzetkih glavnih značilnosti zdravila (kar lahko povzroči bolj variabilne rezultate, saj nekatere ptice popijejo več vode z zdravilom kot druge, vendar pa bolje prikažejo, kaj bi se zgodilo „na terenu“);
Dose rates less than 8.3 mg/kg bw were highly effective and the MIC study indicated that A.paragallinarium is highly susceptible to enrofloxacin. 
Odmerki, manjši od 8,3 mg/kg telesne mase, so bili zelo učinkoviti, študija MIK pa je pokazala, da je A. paragallinarium zelo občutljiv za enrofloksacin.
• Breed of bird used in the study; faster-growing or slower-growing; different metabolism; 
• vrsta ptic, uporabljenih v študiji; hitro- ali počasi rastoče živali, različna presnova;
Gliniana 32, 20-616 Lublin, Poland 
Gliniana 32, 20-616 Lublin Poljska
These showed that there is a gradual increase in MIC and resistance over the last 10 years. 
Te so pokazale, da se MIK in odpornost v zadnjih 10 letih postopoma večata.
Rates of decreased susceptibility of E. coli to ciprofloxacin (based on an epidemiological cut-off of 0.06 mg/l) were 19.3% in 1999-2000 and 33.5% in 2005-2006. 
Deleži zmanjšane občutljivosti E. coli za ciprofloksacin (na podlagi epidemiološke mejne vrednosti 0,06 mg/l) so bili 19,3 % v letih 1999-2000 in 33,5 % v letih 2005-2006.
The study by Evans at al (2009)17 concluded that in the UK humans infected with fluoroquinoloneresistant Campylobacter did not suffer a more severe disease than those infected with susceptible Campylobacter even when use of antimicrobials is taken into account, however the authors did not state if there was any impact on specific vulnerable sub-groups. 
(2009)17 zaključili, da se pri ljudeh v Združenem kraljestvu, okuženih s proti fluorokinolonom odporno bakterijo Campylobacter, ni razvila hujša bolezen kot pri ljudeh, okuženih z občutljivo bakterijo Campylobacter, tudi če se upošteva uporaba protimikrobnih zdravil, vendar avtorji niso navedli, ali je bil prisoten vpliv na posebne ranljive podskupine.
24010 Leon, Spain 
24010 Leon, Španija
Given the inter-individual variability surrounding Css values and the fact that several studies quoted MIC90 values for enrofloxacin against E. coli of 0.5-1 µg/ml, it seems that plasma concentrations greater than the MIC would not be achieved in all individuals against all isolates. 
Glede na variabilnost vrednosti Css med posameznimi živalmi in na podlagi več študij, ki so navedle vrednosti MIK90 za enrofloksacin proti E. coli od 0,5 do 1 µg/ml, je videti, da koncentracije v plazmi, večje od MIK, ne bodo dosežene pri vseh živalih in proti vsem izolatom.
Luxembourg Bayer Belgium J.E. 
Luksemburg Bayer Belgium J.E.
Turkeys: Meat and offal: 13 days. 
Purani: meso in organi: 13 dni.
Clinical resistance of E.coli in chickens to ciprofloxacin was 1.9% in 1999-2000 and increased through 2002-2003 to 5.9% in 2005-2006. 
Klinična odpornost E. coli proti ciprofloksacinu pri piščancih je bila v letih 19992000 1,9 %, v letih 2002-2003 pa se je večala, tako da je v letih 2005-2006 dosegla 5,9 %.
A comprehensive review of data regarding resistance in E.coli, Salmonella sp and Campylobacter spp (bacteria of concern to human health) from poultry from EU Member States isolated during 2002-2009 was provided. 
Predložen je bil izčrpen pregled podatkov o odpornosti bakterij E. coli, Salmonella sp in Campylobacter spp (bakterij, nevarnih za zdravje človeka), izoliranih med letoma 2002 in 2009, pri perutnini iz držav članic EU.
The susceptibility of E.coli isolated predominantly from Germany as part of the GermVet 20087 and 20098 and Germap 20109 resistance monitoring during 2004-2009 was provided. 
Predložili so se podatki za obdobje med letoma 2004 in 2009 o občutljivosti E. coli, izolirani predvsem v Nemčiji v sklopu spremljanja odpornosti GermVet 20087 ter 20098 in Germap 20109.
Romania INVESA C/ Esmeralda 19-21 08950 Esplugues de Llobregat, Barcelona Spain 
Romunija INVESA C/ Esmeralda 19-21 08950 Esplugues de Llobregat, Barcelona Španija
A further study by the same authors determined that treatment with a therapeutic dose of enrofloxacin for a prolonged duration (up to 35 days) to 21 day old broiler chickens did not cause arthropathy in growing chickens and toxicity is not caused by cumulative effects. 
Nadaljnja študija istih avtorjev je pokazala, da dolgotrajno (do 35 dni) zdravljenje pitovnih piščancev, starih 21 dni, s terapevtskim odmerkom enrofloksacina, ni povzročilo artropatije pri rastočih piščancih in da kumulativni učinki niso povzročili toksičnosti.
The evaluation of data generated in fulfilment of these conditions should be undertaken by CVMP in the interests of maintaining the harmonised EU approach achieved by this referral procedure, and given the EU-wide importance of achieving an optimal dose regimen for this range of products. 
Odbor CVMP mora oceniti podatke, zbrane za namene izpolnjevanja teh pogojev, kar bo omogočalo vzdrževanje usklajenega pristopa v EU, ki se bo vzpostavil s tem napotitvenim postopkom, in določitev optimalnega režima odmerjanja za ta nabor zdravil, ki so v EU zelo pomembna.
Usually resistance to fluoroquinolones arises spontaneously because of point mutations that result in amino acid substitutions within the topoisomeerase subunits gyrA, gyrB, parC or parE, a decreased expression of outer membrane porins, or an overexpression of multidrug efflux pumps. 
Navadno se odpornost proti fluorokinolonom pojavi spontano zaradi točkastih mutacij, ki povzročajo substitucije aminokislin znotraj podenot topoizomeraze gyrA, gyrB, parC ali parE, zmanjšanega izražanja porinov zunanje membrane ali čezmernega izražanja črpalk za prehajanje več zdravil.
The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to consider the indications, dosage regimens and withdrawal periods for chickens and turkeys in order to ensure consumer safety, efficacious treatment in chickens and turkeys, as well as lower the risk of development of antimicrobial resistance to enrofloxacin. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) so prosili, naj preveri indikacije, režime odmerjanja in karence za piščance in purane, da bi zagotovili varnost potrošnikov, učinkovito zdravljenje piščancev in puranov ter zmanjšali tveganje razvoja odpornosti mikroorganizmov proti enrofloksacinu.
Reus - Vinyols Km 4,1 Riudoms 43330 (Tarragona) Spain 
Reus - Vinyols Km 4,1 Riudoms 43330 (Tarragona) Španija
Overall summary of the scientific evaluation of all veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see Annex I) 
Splošni povzetek znanstvenega vrednotenja vseh zdravil za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in/ali puranom v vodo za pitje (glejte Prilogo I)
Field studies conducted in 1997-1998 showed that an inclusion rate of 50 ppm reduced clinical signs but the pathogen was not eliminated. 
Terenske študije, opravljene med letoma 1997 in 1998, so pokazale, da je vsebnost 50 ppm zmanjšala klinične znake, vendar do odprave patogena ni prišlo.
Amend where applicable: 
Spremenite, kadar je primerno:
Alternative treatments include amoxicillin, tetracyclines, macrolides and sulphonamides. 
Druge oblike zdravljenja vključujejo amoksicilin, tetracikline, makrolide in sulfonamide.
This review states that multiple studies have demonstrated the rapid development of fluoroquinolone resistant mutants in chickens originally infected with fluoroquinolone-susceptible C.jejuni, but treated with enrofloxacin. 
Poročilo navaja, da je več študij pokazalo hiter razvoj proti fluorokinolonom odpornih mutant pri piščancih, izvirno okuženih z za fluorokinolone občutljivo C.jejuni in zdravljenih z enrofloksacinom.
There are adequate data to support the indication of Mycoplasma spp in turkeys, based on the fact that they are considered a minor species and extrapolation can be made from the data in chickens. 
Podatki za podporo indikacije za Mycoplasma spp pri puranih so zadostni, saj so purani manj pomembne vrste, zato se lahko podatki ekstrapolirajo iz podatkov pri piščancih.
• on the basis of the available residue depletion data in chickens and turkeys, the CVMP considered that withdrawal periods of 7 days for chicken meat and offal and 13 days for turkeys meat and offal were safe; 
• na podlagi razpoložljivih podatkov o črpanju ostankov pri piščancih in puranih je odbor CVMP menil, da je varna karenca za meso in drobovje piščancev 7 dni, za meso in drobovje puranov pa 13 dni;
The Joint ECDC/EFSA/EMA scientific opinion15 identified resistance to fluoroquinolones in salmonella of major concern for public health as ciprofloxacin is the antimicrobial of choice for treatment of severe or invasive Salmonella infections in humans. 
Z združeno strokovno presojo agencij ECDC/EFSA/EMA15 je bila ugotovljena odpornost salmonele proti fluorokinolonom, kar je zelo nevarno za javno zdravje, saj je ciprofloksacin antibiotik prve izbire za zdravljenje hude ali invazivne okužbe s salmonelo pri človeku.
The MIC50 and MIC90 values of the E coli isolates were 1 and 32 mg/L, respectively, which results in Cmax/MIC and AUC/MIC parameters considerably below the breakpoints for fluoroquinolones. 
Vrednosti MIK50 in MIK90 za izolate E. coli sta bili 1 oziroma 32 mg/l, kar je povzročilo, da so bili parametri Cmax/MIK in AUC/MIK precej po mejo za fluorokinolone.
Grójecka 6, 05-651 Drwalew, Poland 
Grójecka 6, 05-651 Drwalew Poljska
Treatment of infections caused by the following bacteria susceptible to enrofloxacin: Chickens 
Zdravljenje okužb, ki jih povzročajo naslednje bakterije, občutljive za enrofloksacin: Piščanci
The mutant population continues to persist even after removal of the selection pressure as fluoroquinolone resistance mediated by gyrA mutations can be stably maintained in Campylobacter and possess an enhanced fitness. 
Populacija mutant vztraja tudi po odstranitvi selekcijskega pritiska, saj se lahko odpornost proti fluorokinolonom, ki jo pri bakteriji Campylobacter povzročajo mutacije gyrA, stabilno vzdržuje in ima okrepljeno prilagodljivost.
In the strains that were isolated, resistance to ciprofloxacin was absent. 
V izoliranih sevih niso ugotovili odpornosti proti ciprofloksacinu.
Dose rates up to 35.4 mg/kg in young broilers showed optimum reduction in mortality and reduction in E.coli reisolation rate. 
Odmerki do 35,4 mg/kg so pri mladih pitovnih piščancih povzročili optimalno zmanjšanje umrljivosti in zmanjšan delež ponovne izolacije E. coli.
In addition, PK/PD concepts have recently been developed that use the hypothesis of the mutant selection window in order to elaborate a dosing regimen that can limit the emergence of resistant organisms (Drlica & Zhao, 2007)13. 
Poleg tega so se nedavno razvili farmakokinetični/farmakodinamični koncepti, ki za izboljšanje režima odmerjanja, ki lahko omeji pojavnost odpornih organizmov, uporablja hipotezo okna za selekcijo mutant (Drlica in Zhao 2007)13.
Cmax was determined as approximately 0.67 µg/ml in healthy birds and 0.54 µg/ml in sick birds infected with APEC, and AUC0-24 as 7.4 mg/h/l in healthy birds and 7.7 mg/h/l in sick birds. 
Pri zdravih pticah je bila vrednost Cmax 0,67 µg/ml in 0,54 µg/ml pri bolnih pticah, okuženih z APEC, vrednost AUC0-24 pa je bila 7,4 mg/h/l pri zdravih pticah in 7,7 mg/h/l pri obolelih pticah.
Two references were provided showing that in 1993, the Minimum Inhibitory Concentration (MIC) of enrofloxacin to M.gallisepticum isolates was 0.0125-0.1 µg/ml and for M.synoviae it was 0.01250.8 µg/ml, and in 1997, MIC for M.gallisepticum isolates was 0.025-1.0 µg/ml and for M.synoviae it was 0.05-0.5 µg/ml. 
Dve predloženi referenci sta pokazali, da je bila leta 1993 minimalna inhibitorna koncentracija (MIK) enrofloksacina proti izolatom M. gallisepticum 0,0125-0,1 µg/ml in proti M. synoviae 0,01250,8 µg/ml, leta 1997 pa 0,025-1,0 µg/ml proti M. gallisepticum in 0,05-0,5 µg/ml proti M. synoviae.
• on the basis of the available data, the CVMP considered that the current dosing regimen for E. coli infections is not optimised in terms of efficacy or limiting the development of resistance in this target pathogen; 
• na podlagi razpoložljivih podatkov je odbor CVMP menil, da trenutni režim odmerjanja proti okužbam z E. coli ni optimiziran glede učinkovitosti ali omejevanja razvoja odpornosti pri tem ciljnem patogenu;
ACROLIN 10 solução oral para frangos de carne 
ACROLIN 10 solução oral para frangos de carne pitovni piščanci
The current dosing regimen for E. coli infections is not considered to be optimised in terms of efficacy or limiting the development of resistance in this target pathogen. 
Trenutni režim odmerjanja proti E. coli ni optimiziran glede učinkovitosti ali omejevanja razvoja odpornosti pri tem ciljnem patogenu.
Enrofloxacin is active against many Gram-negative bacteria, against Gram-positive bacteria and Mycoplasma spp. 
Enrofloksacin je učinkovit proti mnogim gramnegativnim bakterijam, grampozitivnim bakterijam in proti Mycoplasma spp.
Chickens: Meat and offal: 7 days. 
Piščanci: meso in organi: 7 dni.
In this regard, turkeys are recognised as being a minor species. 
Pri tem so purani manj pomembna vrsta;
Do not administer to layer replacement birds within 14 days of coming into lay. 
Ne uporabite pri nadomestnih kokoših nesnicah v obdobju 14 dni, preden začnejo nesti jajca.
Veterinary medicinal products as oral solutions contain 50 mg, 100 mg or 200 mg enrofloxacin per ml for use in drinking water. 
Zdravila za uporabo v veterinarski medicini v obliki peroralnih raztopin vsebujejo 50 mg, 100 mg ali 200 mg enrofloksacina na ml za dajanje v vodo za pitje.
4.2 Indications for use, specifying the target species Treatment of infections caused by the following bacteria susceptible to enrofloxacin: Chickens 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje okužb, ki jih povzročajo naslednje bakterije, občutljive za enrofloksacin: Piščanci
Czysta 4, 96-100 Skierniewice, Poland 
Czysta 4, 96-100 Skierniewice Poljska
Ireland HCS bvba, H. Kennisstraat 53, 2650 Edegem, Belgium 
HCS bvba, H. Kennisstraat 53, 2650 Edegem Belgija
24010 Leon Spain 
24010 Leon Španija
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 DNK-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.
A further warning in section 4.4 of the SPCs should be added also to advise that treatment of mycoplasma infections may not eradicate the organism. 
Prav tako je treba dodati opozorilo v poglavje 4.4 povzetka glavnih značilnosti zdravila, ki navaja, da pri zdravljenju okužb z mikoplazmo morda ne bo prišlo do eradikacije organizma.
In total, approximately 2000 isolates from broilers, turkeys and layers showed that the overall MIC range was 0.015-≥32 µg/ml, with up to 8.7% resistance. 
Skupno približno 2 000 izolatov iz pitovnih piščancev, puranov in nesnic je pokazalo, da je bil splošni razpon MIK od 0,015 do ≥ 32 µg/ml, odpornost pa 8,7-odstotna.
A considerable number of studies and references have been submitted to support the indication of E.coli. 
V podporo indikaciji za E. coli je bilo predloženih veliko študij in referenc.
Laboratorios Maymo, S.A., Via Augusta 302, 08017 Barcelona Spain 
Laboratorios Maymo, S.A., Via Augusta 302, 08017 Barcelona Španija