natgillin/translations-raw huggingface dataset:
It has been postulated that AUC0-24h/MIC and Cmax/MIC ratios of >100 and >8, respectively, are predictive of clinical outcome for fluoroquinolones. 
Predpostavili so, da sta razmerji AUC0-24h/MIK > 100 in Cmax/MIK > 8 prediktorja za klinični izid uporabe fluorokinolonov.
Tolerance data from 2009 show that at doses of 300 and 600 mg enrofloxacin /kg bw administered once or for 5 days to 21 day old broiler chickens, diarrhoea and abnormal behaviour such as reluctance to move, reduced motor activity and disturbed coordination of movement were seen. 
Podatki o toleranci iz leta 2009 kažejo, da so pri odmerkih 300 in 600 mg enrofloksacina/kg telesne mase, ki so se v obliki enkratnega odmerka ali 5 dni dajali pitovnim piščancem, starim 21 dni, opazili diarejo in nenormalno vedenje, kot so odpor do premikanja, zmanjšana motorična dejavnost ter motena koordinacija gibov.
In Europe, several antimicrobials are authorised for treatment of colibacillosis in chickens and turkeys (apramycin, chlortetracycline, colistin, difloxacin, doxycycline and sulphadiazine + trimethoprim), but the widespread multidrug resistance of pathogenic E.coli has led to the extensive use of enrofloxacin. 
V Evropi so za zdravljenje kolibaciloze pri piščancih in puranih odobrena mnoga protimikrobna zdravila (apramicin, klortetraciklin, kolistin, difloksacin, doksiciklin in kombinacija sulfadiazina ter trimetoprima), vendar je razširjena odpornost patogene E. coli proti več zdravilom povzročila obsežno uporabo enrofloksacina.
A report by Sellyei et al, 20094, advised that although P.multocida isolates are susceptible to most widely used antimicrobials, remarkable resistance was detected to sulphonamides, tetracyclines, first generation quinolones and aminoglycosides. 
20094 so v svojem poročilu navedli, da čeprav so izolati P. multocida občutljivi za večino splošno uporabljanih protimikrobnih zdravil, se je ugotovila znatna odpornost proti sulfonamidom, tetraciklinom, kinolonom prve generacije in aminoglikozidom.
In the more recent laboratory study (2007) which simulated field conditions, turkeys were administered enrofloxacin at 10 mg/kg bw for 5 days, but the re-isolation rate was not investigated. 
V novejši laboratorijski študiji (2007), ki je simulirala pogoje na terenu, so puranom 5 dni dajali enrofloksacin v odmerku 10 mg/kg telesne mase, vendar deleža ponovne izolacije niso preučevali.
• The marketing authorisation holders should also provide scientific justification/s that this new dosing regimen will be effective for the treatment of the remaining target pathogens in the SPC. 
• imetniki dovoljenj za promet z zdravilom morajo v povzetek glavnih značilnosti zdravila vključiti tudi znanstveno(e) utemeljitev(ve), da bo nov režim odmerjanja učinkovit pri zdravljenju preostalih ciljnih patogenov;
• due to the lack of support for the dosing regimen, especially in regards to elimination of infection, and EU legislation in regards to national control programmes for the control of salmonella in poultry that state that antimicrobials should not be used except in exceptional circumstances (Regulation EC 1177/2006), the CVMP considered that the indication for treatment of salmonella infections should be removed from the SPCs; 
• zaradi pomanjkljive podpore za režim odmerjanja, zlasti v povezavi z odpravo okužbe, in zakonodaje EU, povezane z nacionalnimi programi za nadzorovanje salmonele pri perutnini, ki navaja, da se smejo protimikrobna zdravila uporabljati samo v izjemnih okoliščinah (Uredba (ES) 1177/2006), je odbor CVMP menil, da je treba indikacijo za zdravljenje okužb s salmonelo odstraniti iz povzetkov glavnih značilnosti zdravila;
Two studies conducted in 1997 and 2002 both demonstrated that when birds were infected with E.coli with reduced susceptibility, MIC=0.5 µg/ml, the efficacy of 10 mg/kg enrofloxacin was reducedclinical signs were less well controlled and in one study mortality was approximately 43%. 
Študiji, opravljeni v letih 1997 in 2002, sta pokazali, da se je pri pticah z zmanjšano občutljivostjo (MIK = 0,5 g/ml), okuženih z E. coli, učinkovitost enrofloksacina v odmerku 10 mg/kg zmanjšalaklinični znaki so bili manj nadzorovani in v eni študiji je bila umrljivost približno 43-odstotna.
Available online at www.efsa.europa.eu/efsajournal for non-pathogenic strains. 
Na voljo na spletu na www.efsa.europa.eu/efsajournal
Ceva Animal Health Slovakia, spol s r.o., Račianska 77, 831 02 Bratislava, Slovakia 
Ceva Animal Health Slovakia, spol s.r.o., Račianska 77, 831 02 Bratislava, Slovaška
Calier Portugal, S.A Centro Empresarial Sintra Estoril II, Ed. C, R. Pé do Mouro Estrada de Albarraque 
Portugalska Calier Portugalska, S.A Centro Empresarial Sintra Estoril II, Ed. C,
When administered continuously in drinking water (based on a daily dose of 10 mg/kg bw), steadystate plasma concentrations (Css) for enrofloxacin were 0.33 ± 0.04 µg/ml in turkeys and 0.56 ± 0.13 µg/ml in chickens. 
Ko se je enrofloksacin neprekinjeno dajal v vodo za pitje (na podlagi dnevnega odmerka 10 mg/kg telesne mase), so bile koncentracije enrofloksacina v plazmi v stanju dinamičnega ravnovesja (Css) 0,33 ± 0,04 µg/ml pri puranih in 0,56 ± 0,13 µg/ml pri piščancih.
Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of E.coli to fluoroquinolones and emergence of resistant organisms. 
Ker je bil enrofloksacin najprej odobren pri perutnini, je prišlo do obsežnega zmanjšanja občutljivosti E. coli za fluorokinolone in pojava odpornih organizmov.
MIC90 was determined as 0.5 µg/ml in most references. 
V večini reference je bila koncentracija MIK90 določena pri 0,5 µg/ml.
06511 Carros cedex France 
06511 Carros cedex Francija
Farma vet Ltd. 40 Otec Paisii Str. Shumen 9700 
Bolgarija Farma vet Ltd. 40 Otec Paisii Str.
A further field study conducted in the EU demonstrated that dose rates up to 20.6 mg/kg bw again controlled signs but did not eliminate the pathogen. 
Druga študija, opravljena v EU, je prav tako pokazala, da so odmerki do 20,6 mg/kg telesne mase nadzorovali znake, vendar niso povzročili odprave patogena.
A comprehensive PK/PD analysis was provided. 
Preložena je bila izčrpna farmakokinetična/farmakodinamična analiza.
Ceva Santé Animale, 10 avenue de La Ballastière, 33500 Libourne France 
Ceva Santé Animale, 10 avenue de La Ballastière, 33500 Libourne Francija
Crta de Castellvell, 24 43206 Reus (Tarragona) Spain 
Crta de Castellvell, 24 43206 Reus (Tarragona) Španija
In vitro susceptibility has been shown in strains of (i) Gram-negative species such as Escherichia coli, Pasteurella multocida and Avibacterium (Haemophilus) paragallinarum and (ii) Mycoplasma gallisepticum and Mycoplasma synoviae. 
Občutljivost so in vitro pokazali pri sevih i) gramnegativnih vrst, kot so Escherichia coli, Pasteurella multocida ter Avibacterium (Haemophilus) paragallinarum, in (ii) Mycoplasma gallisepticum ter Mycoplasma synoviae.
One study also demonstrated that continuous administration of the product at 10 mg/kg bw was better than pulsed 
Ena študija je prav tako pokazala, da je bila neprekinjena uporaba zdravila v odmerku 10 mg/kg telesne mase boljša od impulzne uporabe v istem odmerku.
The MIC of the challenge strain was 0.06 µg/ml, where reported. 
Koncentracija MIK proti sevu, uporabljenem v provokacijskem testu, je bila 0,06 µg/ml, kadar so o njej poročali.
Pharmacotherapeutic group: quinolone and quinoxaline antibacterials, fluoroquinolones. 
Farmakoterapevtska skupina: kinoloni in kinoksalini; fluorokinoloni.
08620 Sant Vicenc del Horts, Barcelona Spain 
08620 Sant Vicenc del Horts, Barcelona Španija
s r.o., Murgašova 5, 949 01 Nitra, Slovakia 
s r.o., Murgašova 5, 949 01 Nitra Slovaška
Romania DIVASA - FARMAVIC, S.A. Ctra Sant Hipolit Km 71 
Romunija DIVASA - FARMAVIC, S.A. Ctra Sant Hipolit Km 71
Three references were provided to justify that the pharmacokinetics of enrofloxacin in turkeys is very similar to that of chickens. 
V podporo, da je farmakokinetika enrofloksacina pri puranih zelo podobna farmakokinetiki pri piščancih, so bile predložene tri reference.
There has been much debate as to whether quinolone resistant Campylobacter infection is associated with adverse human health consequences. 
Mnenja o tem, ali je okužba s Campylobacter, odporna proti kinolonom, povezana z neželenimi posledicami za zdravje ljudi, so protislovna.
However according to the EFSA/ECDC report (2012)5 resistance to ciprofloxacin in indicator E.coli isolates taken from chickens is described as moderate to high at a rate of 47%. 
V poročilu agencij EFSA/ECDC (2012)5 pa je odpornost proti ciprofloksacinu pri indikatorskih izolatih E.coli iz piščancev opisana kot zmerna do velika, s 47odstotnim deležem.
Rue 13eme Rue 06511 Carros Cedex, France 
Rue 13eme Rue 06511 Carros Cedex Francija
In October 2012, following an Article 34 referral procedure for Baytril 10% Oral Solution (EMEA/V/A/067) the indication for treatment of salmonella infections has been removed from the SPC due to the lack of support for the dosing regimen, especially in regards to elimination of infection, and EU legislation in regards to national control programmes for the control of salmonella in poultry that state that antimicrobials should not be used except in exceptional circumstances (Regulation EC 1177/2006). 
Oktobra 2012 je bila skladno z napotitvenim postopkom iz člena 34 za zdravilo Baytril 10% Oral Solution (EMEA/V/A/067) iz povzetka glavnih značilnosti zdravila odstranjena indikacija za zdravljenje okužb s salmonelo zaradi pomanjkanja podpornih podatkov za režim odmerjanja, zlasti v povezavi z odpravo okužbe, in zaradi zakonodaje EU, povezane z nacionalnimi programi za nadzorovanje salmonele pri perutnini, ki navaja, da se smejo protimikrobna zdravila uporabljati samo v izjemnih okoliščinah (Uredba (ES) 1177/2006).
s.r.o., Murgašova 5, 949 01 Nitra Slovak Republic 
s.r.o., Murgašova 5, 949 01 Nitra Slovaška
In a previous study, the Minimal Bactericidal Concentration (MBC) of 0.06 µg/ml and mutant prevention concentrations (MPC) of 4 µg/ml were determined for this O78/H12 pathogenic strain. 
V prejšnji študiji sta se za ta patogeni sev O78/H12 določili minimalna baktericidna koncentracija (MBC) 0,06 µg/ml in koncentracija za preprečevanje mutacij (MPC) 4 µg/ml.
• the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I), subject to amendments in the product information and conditions on the marketing authorisations; the CVMP has recommended the variations of the marketing authorisations for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I of the opinion) in order to amend the summaries of product characteristics, labelling and package leaflets as set out in annex III. 
• odbor CVMP je menil, da je splošno razmerje med tveganji in koristmi za zdravila za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in/ali puranom v vodo za pitje (glejte Prilogo I) pozitivno, če se upoštevajo spremembe informacij o zdravilu in pogoji dovoljenj za promet z zdravilom; je odbor CVMP priporočil spremembo dovoljenj za promet z zdravilom za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in/ali puranom v vodo za pitje (glejte Prilogo I k mnenju), tako da bodo spremembe, navedene v Prilogi III, uvedene v povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo.
Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets 
Znanstveni zaključki in podlaga za spremembo povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo
Bayer d.o.o., Bravničarjeva 13 Ljubljana Slovenia 
Slovenija Bayer d. o. o., Bravničarjeva 13
The indication for treatment of salmonella infections should be removed from the SPCs due to the lack of support for the dosing regimen, especially in regards to elimination of infection, and EU legislation in regards to national control programmes for the control of salmonella in poultry that state that antimicrobials should not be used except in exceptional circumstances (Regulation EC 1177/2006). 
Indikacijo za zdravljenje okužb s salmonelo je treba odstraniti iz povzetkov glavnih značilnosti zdravila zaradi pomanjkljive podpore za režim odmerjanja, zlasti v povezavi z odpravo okužbe, in zakonodaje EU, povezane z nacionalnimi programi za nadzorovanje salmonele pri perutnini, ki navaja, da se smejo protimikrobna zdravila uporabljati samo v izjemnih okoliščinah (Uredba (ES) 1177/2006).
This proposal would ensure the safety of consumers of meat and offal taken from chickens and turkeys treated with the veterinary medicinal products containing enrofloxacin for administration via drinking water to chickens and turkeys at the recommended dose of 10 mg/kg bw/day for 5 consecutive days. 
Ta predlog bo zagotovil varnost potrošnikov mesa in drobovine piščancev ter puranov, zdravljenih z zdravili za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se piščancem ter puranom 5 dni dajejo v vodo za pitje v priporočenem odmerku 10 mg/kg telesne mase/dan.
Fluoroquinolones are recognised as veterinary critically important antimicrobials in the treatment of colibacillosis septicaemia and chronic respiratory disease in poultry. 
Fluorokinoloni so izjemno pomembna protimikrobna zdravila v veterinarski medicini za zdravljenje koliseptikemije in kronične bolezni dihal pri perutnini.
There is a wide mutant selection window between 0.06 and 4 µg/ml which supports the fact that the pathogenic strain could not be eradicated after treatment with even a high dose of enrofloxacin. 
Ker je okno za selekcijo mutant med 0,06 in 4 µg/ml široko, tudi po zdravljenju z velikim odmerkom enrofloksacina ni prišlo do eradikacije patogenega seva.
10 mg enrofloxacin/kg bodyweight per day for 3-5 consecutive days. 
10 mg enrofloksacina/kg telesne mase na dan od 3 do 5 zaporednih dni
Taking account of the overall data, the indication for the treatment of P.multocida in chickens and turkeys is justified at a dose of 10 mg/kg bw for 3-5 days. 
Upoštevajoč splošne podatke je indikacija za zdravljenje P. multocida pri piščancih in puranih v odmerku 10 mg/kg telesne mase od 3 do 5 dni upravičena.
Another study demonstrated that a dose rate of 12.52 mg/kg bw administered for 3 days controlled signs of disease but did not eliminate the pathogen. 
Še ena študija je pokazala, da je odmerek 12,52 mg/kg telesne mase, ki se je dajal 3 dni, nadzoroval znake, ni pa odpravil patogena.
When site of infection lung levels of enrofloxacin of 0.84 µg/g are considered, against the same pathogen, Cmax/MIC is far below the clinically predictive value of 8. 
Tudi pri ravneh enrofloksacina 0,84 µg/g na mestu okužbe v pljučih je bilo razmerje Cmax/MIK proti istemu patogenu precej pod klinično napovedno vrednostjo 8.
The 2009 experimental study (using a susceptible E.coli isolate) showed that a daily dose of 10 mg/kg bw for 5 days was more effective at controlling disease and reducing E.coli re-isolation compared to the total dose (50 mg/kg bw) administered over a 20 hours period when E.coli was detected in the trachea 4 days after the onset of treatment. 
Eksperimentalna študija iz leta 2009 (v kateri so uporabili občutljiv izolat E. coli) je pokazala, da je bil dnevni odmerek 10 mg/kg telesne mase, ki se je dajal 5 dni, učinkovitejši pri nadzorovanju bolezni in zmanjševanju ponovne izolacije E. coli v primerjavi s skupnim odmerkom (50 mg/kg telesne mase), ki se je dajal v obdobju 20 ur, če se je E. coli 4 dni po začetku zdravljenja ugotovila v sapniku.
The overall benefit-risk balance for the veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys (see annex I) is deemed positive subject to the recommended changes in the product information (see annex III) and, in view of the need to obtain further data in order fully to address the public health issues that have given rise to this referral procedure, subject to the imposition of conditions affecting the Marketing Authorisations (see annex IV). 
Splošno razmerje med tveganji in koristmi pri zdravilih za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in/ali puranom v vodo za pitje (glejte Prilogo I), je pozitivno, če se v informacije o zdravilu uvedejo priporočene spremembe (glejte Prilogo III) in zaradi potrebe po pridobivanju dodatnih podatkov za optimalno obravnavo težav javnega zdravja uveljavijo pogoji, ki vplivajo na dovoljenja za promet z zdravilom (glejte Prilogo IV).
All products are administered at the dose of 10 mg enrofloxacin per kg body weight (bw). 
Vsa zdravila se dajejo v odmerku 10 mg enrofloksacina na kg telesne mase.
Alternative therapies include amoxicillin, erythromycin, tetracyclines and sulphonamides, although resistance which may be plasmid-borne has been reported to aminoglycosides and macrolides in Asia. 
Druge oblike zdravljenja vključujejo amoksicilin, eritromicin, tetracikline in sulfonamide, v Aziji pa so poročali o odpornosti proti aminoglikozidom in makrolidom, ki bi bila lahko posledica prenašanja s plazmidi.
Therefore, a warning in Section 4.5 of the Summaries of Products Characteristics (SPCs) that resistance has been identified in M.synoviae in the EU should be added to highlight the risk. 
Da bi izpostavili to tveganje, je treba v poglavje 4.5 povzetka glavnih značilnosti zdravila dodati, da so v EU ugotovili odpornost M. synoviae.
Romania Hipra Laboratorios Avda. 
Romunija Hipra Laboratorios Avda.
GENERA SI d.o.o., Dunajska 51, 1000 Ljubljana Slovenia 
Slovenija GENERA SI d. o. o., Dunajska 51,
Fluoroquinolones are recognised as veterinary critically important antimicrobials in the treatment of colibacillosis septicaemia and chronic respiratory disease in poultry with few effective alternatives, therefore the indication should be maintained. 
Fluorokinoloni so izjemno pomembna protimikrobna zdravila za uporabo v veterinarski medicini za zdravljenje koliseptikemije in kronične bolezni dihal pri perutnini, saj je na voljo le nekaj drugih učinkovitih oblik zdravljenja, zato je treba indikacijo ohraniti.
• on the basis of the available data, the CVMP considered that indications for M.gallisepticum, M.synoviae, A.paragallinarium, P.multocida and E.coli in chickens and M.gallisepticum, M.synoviae, P.multocida and E.coli in turkeys should be maintained; 
• na podlagi razpoložljivih podatkov je odbor CVMP menil, da je treba indikacije za M.gallisepticum, M.synoviae, A.paragallinarium, P.multocida in E.coli pri piščancih ter M.gallisepticum, M.synoviae, P.multocida in E.coli pri puranih ohraniti;
The withdrawal periods should be set 7 days for chickens and 13 days for turkeys to ensure consumer safety at the recommended dose of 10 mg/kg bw/day for 5 consecutive days 
Karenca mora biti 7 dni pri piščancih in 13 dni pri puranih, da se zagotovi varnost potrošnikov, če se zdravilo 5 zaporednih dni uporablja s priporočenim odmerkom 10 mg/kg telesne mase/dan.
• Taking into account the decreases in the susceptibility profiles of E. coli observed in EU surveillance from the time enrofloxacin was first authorised in poultry species, a dosing regimen should be elaborated based on new studies that encompass the current susceptibility of E. coli and new PK/PD concepts aimed at limiting the development of resistance for the target pathogens. 
• upoštevajoč zmanjšanja pri profilih občutljivosti E. coli, opažena v programih nadzorovanja v EU od prve odobritve enrofloksacina pri perutnini, je treba vzpostaviti režim odmerjanja, ki bo temeljil na novih študijah, ki upoštevajo trenutno občutljivost E. coli ter nove farmakokinetične/farmakodinamične koncepte, katerih cilj je omejitev razvoja odpornosti proti ciljnim patogenom.
Poultry (chicken) 
perutnina (pitovni piščanci)
It should be noted that levels of enrofloxacin in the lungs of chickens have been consistently reported as 0.88 µg/g after chickens have been dosed with enrofloxacin at 10 mg/kg bw. 
Omeniti je treba, da so po odmerjanju 10 mg enrofloksacina/kg telesne mase dosledno poročali o ravneh enrofloksacina v pljučih piščancev 0,88 µg/g.
According to the EFSA summary report, 2010, the level of resistance (defined by epidemiological cutoff values) to ciprofloxacin in Campylobacter jejuni isolates from broiler chickens was 47%, although there is variability between Member States. 
Glede na povzetek poročila agencije EFSA iz leta 2010 je bil delež odpornosti (opredeljene z epidemiološkimi mejnimi vrednostmi) proti ciprofloksacinu pri izolatih Campylobacter jejuni iz pitovnih piščancev 47-odstoten, čeprav se razlikuje med državami članicami.
The most recent report (Reinhardt et al 2005)2 demonstrated that, even with treatment with enrofloxacin at 10 mg/kg bw, the pathogen was not eradicated and when birds were stressed at up to 3 months after the initial inoculation, M.gallisepticum was reactivated. 
2005)2 je pokazalo, da kljub zdravljenju z enrofloksacinom v odmerku 10 mg/kg telesne mase ni prišlo do eradikacije patogena in da se je patogen M. gallisepticum ponovno aktiviral, če so bile ptice pod stresom do 3 mesece po prvotni inokulaciji.
4.11 Withdrawal period(s) Chickens: Meat and offal: 7 days. 
Spremenite, kadar je primerno: 4.11 Karenca Piščanci: meso in organi: 7 dni.
The data do not conclusively justify the proposed dose rate against the named mycoplasma species. 
Podatki predlaganega razporeda odmerjanja proti navedenim vrstam mikoplazme ne upravičijo prepričljivo.
ESTEVE FARMA, LDA Av. Do Forte 3 - Edifício Suécia II, Piso 4A 2794-044 Carnaxide Portugal 
Portugalska ESTEVE FARMA, LDA Av. Do Forte 3 - Edifício Suécia II, Piso 4A
The studies showed that a dose of 10 mg/kg bw for 5 days controlled clinical signs in the field but only reduced re 
Študije so pokazale, da so se z odmerkom 10 mg/kg telesne mase, ki se je dajal 5 dni, nadzorovali klinični znaki na terenu, delež ponovne izolacije pa je samo zmanjšal.
MIC data were provided for enrofloxacin against target pathogens (E.coli, P. multocida, M. gallisepticum, M. synoviae) isolated from respiratory tract infections or septicaemia in poultry. 
Za enrofloksacin so bili predloženi podatki o MIK proti ciljnim patogenom (E. coli, P. multocida, M. gallisepticum, M. synoviae), izoliranim iz okužb dihal ali septikemije pri perutnini.
Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany 
Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Nemčija
Resistance rates in E.coli from chickens and turkeys are reported as low in the study by Wallman 2007, where a clinical breakpoint of ≥ 2 mg/l was used and resistance was determined as up to 4.6% in isolates from 2004-2005. 
V študiji, ki jo je leta 2007 opravil Wallman, so poročali o majhnih deležih odpornosti proti E. coli pri piščancih in puranih, če se je uporabila klinična meja ≥ 2 mg/l, med letoma 2004 in 2005 pa je bila odpornost pri izolatih do 4,6-odstotna.
CENAVISA, S.A., Cami Pedra Estela s/n, 43205 Reus (Tarragona) Spain 
CENAVISA, S.A., Cami Pedra Estela s/n, 43205 Reus (Tarragona) Španija
Eleven references were submitted, two of which were dated after 2000, in support of the indication for Mycoplasma spp. 
Za podporo indikacije za patogene Mycoplasma spp se je predložilo enajst referenc, od katerih sta imeli dve datum po letu 2000.
Rákóczi u. 146. 
Madžarska TolnAgro Kft. Rákóczi u. 146.
Although the data provided are not sufficient to conclusively support the dosing regimen, taking into consideration the fact that colibacillosis is a very common disease in turkeys and the importance of fluoroquinolones in its treatment, it is agreed that the indication and dose regimen should remain in the SPCs of the products concerned. 
Čeprav predloženi podatki niso zadostni, da bi prepričljivo podprli režim odmerjanja, so kljub temu sklenili, da ta indikacija in režim odmerjanja ostaneta v povzetku glavnih značilnosti zadevnih zdravil, saj je kolibaciloza zelo pogosta bolezen pri puranih, njeno zdravljenje s fluorokinoloni pa zelo pomembno.