natgillin/translations-raw huggingface dataset:
The data were too variable to be analysed in this way because the studies were not sufficiently similar and the influence of some aspects of study design could not be taken into account when interpreting the findings.
Podatki so bili preveč variabilni, da bi omogočali tak način analize, saj si študije niso bile dovolj podobne, pri interpretaciji ugotovitev pa ni bilo mogoče upoštevati vpliva nekaterih vidikov načrta študije.
INTERSIGN Pechačkova 5, 150 00 Prague 5 Czech Republic
INTERSIGN Pechačkova 5, 150 00 Prague 5 Češka republika
Ilfov, Romania
Ilfov Romunija
Following a referral procedure (EMEA/V/A/067) under Article 34 of Directive 2001/82/EC, the full product information of the ‘pioneer' product ‘Baytril 10% Oral Solution' and it associated names was harmonised with a Commission Decision of 8 October 20121.
Skladno z napotitvenem postopkom (EMEA/V/A/067) iz člena 34 Direktive 2001/82/ES so se celotne informacije o „pionirskem“ zdravilu „Baytril 10% Oral Solution“ in povezanih imenih uskladile s sklepom Komisije z dne 8. oktobra 20121.
The data presented show that the MICs of E.coli have increased over the last 20 years and the approved dose regimen may no longer be optimal.
Predloženi podatki kažejo, da so se koncentracije MIK za E. coli v zadnjih 20 letih povečale, zato odobreni režim odmerjanja morda ne bo več optimalen.
Bayer Hungária Kft, Alkotás u. 50.
Madžarska Bayer Hungária Kft, Alkotás u. 50.
In both species, the available data are rather variable in both quality and outcome.
Pri obeh vrstah so podatki o kakovosti in izidu precej variabilni.
Novimed Kft., Kiss Ernő u. 3.
Madžarska Novimed Kft., Kiss Ernő u. 3.
Consequently it is concluded that Salmonella as a target pathogen should be removed also from the SPCs of all products concerned by this referral procedure.
Posledično je bilo sklenjeno, da je treba salmonelo kot ciljni patogen odstraniti tudi iz vseh povzetkov glavnih značilnosti zdravil, za katera velja ta napotitveni postopek.
These omissions add to the uncertainties that also arise due to the variability in the results of the submitted studies.
Manjkajoči podatki prispevajo k nejasnosti, ki je prav tako posledica variabilnosti rezultatov predloženih študij.
Target species safety
Varnost pri ciljnih vrstah
The majority of studies used an experimental inoculation with M.gallisepticum.
V večini študij so uporabili eksperimentalno inokulacijo z M.gallisepticum.
The Committee agreed that the most conservative withdrawal periods, derived from the better conducted and reported studies, should be established i.e. 7 days for chickens and 13 days for turkeys.
Odbor se je strinjal, da je treba določiti najbolj konzervativne karence, izpeljane iz bolje izvedenih študij z boljšim poročanjem, tj. 7 dni za piščance in 13 dni za purane.
In addition, P.multocida causes acute, serious and highly contagious disease in poultry, therefore there is a justification for having a second line treatment available for this pathogen.
Poleg tega P. multocida pri perutnini povzroča akutno, resno in zelo nalezljivo bolezen, zato je upravičeno, da je za ta patogen na voljo zdravljenje druge izbire.
In order to recommend a dosage regimen, the population variability and the impact of disease on pharmacokinetic parameters needed to be investigated.
Da bi lahko priporočili režim odmerjanja, je treba preučiti variabilnost v populaciji in vpliv bolezni na farmakokinetične parametre.
The following conditions should be fulfilled by all marketing authorisation holders (see annex I):
Vsi imetniki dovoljenj za promet z zdravilom (glejte Prilogo I) morajo izpolniti naslednje pogoje:
Although both studies had been conducted approximately 25 years ago, there are sufficient data to support the indication for A.paragallinarium at the proposed dose rate.
Čeprav sta se študiji opravili pred približno 25 leti, je na voljo dovolj podatkov, ki podpirajo indikacijo za A. paragallinarium ob predlaganem odmerku.
7100 Szekszárd, Hungary
7100 Szekszárd Madžarska
CEVA-Phylaxia Zrt.
Madžarska CEVA-Phylaxia Zrt.
Asklep Farma Lyulin 7, bl.
Bolgarija Asklep Farma Lyulin 7, bl.
It has been shown that both MICs and resistance are increasing within the EU.
Pokazali so, da se koncentracije MIK in odpornost v EU povečujejo.
Romvac Co.S.A, 7 Soseaua Centurii, Voluntari, IF-077190 Romania
Romvac Co.S.A, 7 Soseaua Centurii, Voluntari, IF-077190 Romunija
The field study replicated the situation that would be encountered - a mixed infection which included Mycoplasma spp.
V terenski študiji so ponovili primer, s katerim so se srečali - mešano okužbo, ki je vključevala bakterijo Mycoplasma spp.
Romania S.C.MARAVET SRL 9 Europa,
Romunija S.C.MARAVET SRL 9 Europa,
The paper by de Jong et al6, 2012, quotes data from the EASSA collected from EU countries.
Članek, ki so ga pripravili Jong in sod.6, 2012, navaja podatke EASSA, zbrane v državah EU.
• Size and weight of the birds used in the studies varied considerably, and did not correlate to the calculated length of the WP from each study;
• velikost in telesna masa ptic, uporabljenih v študijah, sta se precej razlikovali in nista bili soodnosni z izračunano dolžino karence v posameznih študijah;
Other MAHs however, did supply these data, and as such, the studies provided by these companies provide more reliable information on which to base a conclusion on the length of the meat withdrawal periods.
Drugi imetniki dovoljenj za promet z zdravilom pa so te podatke predložili, zato so študije, ki so jih predložile te družbe, omogočile zanesljivejše podatke, na osnovi katerih se lahko oblikuje zaključek glede dolžine karence za meso.
For example, approximately 25-35% of enrofloxacin, at any given timepoint, is metabolized to ciprofloxcacin, resulting in subtherapeutic concentrations of ciprofloxacin, that could select for resistant strains, as well as cross-resistance.
Na primer: približno 25-35 % enrofloksacina se na kateri koli časovni točki presnovi na ciprofloksacin, kar povzroči subterapevtske koncentracije ciprofloksacina, ki bi lahko opravile selekcijo za odporne seve, in navzkrižno odpornost.
The CVMP also considered the possibility that there were significant formulation differences between the products that might account for the variability in metabolism and depletion due to potential bioavailability differences; however, the formulations of all the products concerned are very similar, containing similar excipients.
Odbor CVMP je prav tako upošteval možnost, da so bile med zdravili velike razlike v formulaciji, kar lahko razloži variabilnost v presnovi in depleciji zaradi morebitnih razlik v biološki uporabnosti, vendar so formulacije za vsa zadevna zdravila zelo podobne, saj vsebujejo podobne sestavine.
11 Haritova, A., V. Urumova, M. Lutckanov, V. Petrov, and L. Lashev.
11 Haritova, A., V. Urumova, M. Lutckanov, V. Petrov, in L. Lashev.
Although the studies provided are not considered to be of equal reliability, the CVMP attempted a ‘pooled' statistical analysis of all the data provided by all of the studies submitted and found that this method could not be applied, because the statistical parameters (defined by the Bartlett, Shapiro-Wilk and ANOVA (lack of fit) tests) showed a significant deviation from normality (p < 0.01), i.e. the data were not normally distributed and showed no homogeneity of variance.
Čeprav zanesljivost predloženih študij ni enaka, je odbor CVMP poskusil opraviti „združeno“ statistično analizo vseh podatkov iz vseh predloženih študij in ugotovil, da te metode ni mogoče uporabiti, saj so statistični parametri (opredeljeni z (neprilagojenim) Bartlettovim testom, Shapiro-Wilkovim testom in testom ANOVA) pomembno odstopali od normalnosti (p < 0,01), tj. podatki niso bili normalno razporejeni, njihova varianca pa ni bila homogena.
• Most of the studies provided were not reported to current standards, omitting raw data, analytical method validation data and storage stability data.
• večina predloženih študij ni bila skladna s trenutnimi standardi, saj so izključile neobdelane podatke, podatke za validacijo analitične metode in podatke o stabilnosti med shranjevanjem.
Its bactericidal activity inhibits the bacterial DNA-gyrase.
Njegovo baktericidno delovanje zavira bakterijsko DNK-girazo.
The data are sparse but show that lung levels and plasma Cmax are similar, while AUC is greater in turkeys.
Podatki so redki, vendar kažejo, da so vrednosti ravni v pljučih in Cmax v plazmi podobne, medtem ko je vrednost AUC pri puranih večja.
5531 AE Bladel
5531 AE Bladel Nizozemska
28031 Madrid Spain
28031 Madrid Španija
The issue of E.coli is changing with evidence of poultry ESBL E. coli (CTX-M1) in processed meat products and increasing human prevalence of ESBL CTX-M1 infections.
Obravnavanje E.coli se spreminja z dokazi o perutninski bakteriji ESBL-E. coli (CTX-M1) v obdelanih mesnih izdelkih in vedno večji prevalenci okužb z ESBL CTX-M1 pri človeku.
Control programmes aim to eliminate infection from breeding stock.
Cilj kontrolnih programov je odprava okužbe v matični skupini živali.
If the withdrawal period for turkeys is extrapolated from residues studies in chickens, then an additional safety factor should be added to take into account the evidence from previous residues studies that demonstrated that the depletion of enrofloxacin is slower in turkeys than chickens.
Če se karenca za purane ekstrapolira iz študij ostankov pri piščancih, je treba dodati dodaten varnostni faktor, ki bo upošteval dokaze iz prejšnjih študij ostankov, ki so pokazale, da je deplecija enrofloksacina pri puranih počasnejša kot pri piščancih;
The recommendations were carried forward to the CVMP Strategy 2011-2015 and were addressed in the previous Article 35 referral for all veterinary medicinal products for food producing species containing quinolones and/or fluoroquinolones as active substances (EMEA/V/A/049)19 and in the current referral.
Priporočila so se prenesla v Strategijo odbora CVMP 2011-2015 in so se obravnavala v prejšnjem napotitvenem postopku iz člena 35 za vsa zdravila za uporabo v veterinarski medicini za živali, namenjene proizvodnji hrane, ki kot zdravilne učinkovine vsebujejo kinolone in/ali fluorokinolone(EMEA/V/A/049),19 ter trenutnem napotitvenem postopku.
• Where there is a change to the dose regimen for chickens and/or turkeys, then adequate withdrawal periods should be established, according to current guidelines; a revised environmental risk assessment should also be provided; furthermore any potential effects on user and target species safety should be reviewed.
• če se režim odmerjanja za piščance in/ali purane spremeni, je treba skladno s trenutnimi smernicami določiti ustrezne karence, predložiti ponovno oceno tveganja za okolje in pregledati kakršne koli morebitne učinke na varnost uporabnika ter ciljnih vrst.
Vétoquinol s.r.o., Zámečnická 411, 288 02 Nymburk Czech Republic
Vétoquinol s.r.o., Zámečnická 411, 288 02 Nymburk Češka republika
During the above mentioned Article 34 referral procedure for Baytril 10% oral solution and its associated names it became apparent that some of the indications for use in the target species chickens and turkeys were not consistent with the principles of responsible use of antimicrobial veterinary medicinal products and therefore such indications were removed from the harmonised product information.
Med zadevnim napotitvenim postopkom iz člena 34 za zdravilo Baytril 10% oral solution in povezana imena je postalo očitno, da nekatere indikacije za uporabo pri ciljnih živalskih vrstah, piščancih in puranih, niso skladne z načeli odgovorne uporabe protimikrobnih zdravil za uporabo v veterinarski medicini, zato so se te indikacije odstranile iz usklajenih informacij o zdravilu.
RepresentagroRepresentaçoes LDA Estrada da Lapa 1, 2665-540 Venda do Pinheiro,
Portugalska RepresentagroRepresentaçoes LDA Estrada da Lapa 1, 2665-540 Venda do Pinheiro
Quantitative histopathological evaluation revealed no substantial changes in examined articular cartilages in birds treated with doses up to 100 mg/kg bw/day.
Kvantitativna histopatološka ocena ni pokazala nobenih bistvenih sprememb v sklepnem hrustancu pri pticah, zdravljenih z odmerki do 100 mg/kg telesne mase/dan.
Clinical response is also affected by pharmacodynamic variability (host response, population distribution of MIC values for the target pathogen).
Na klinični odziv vpliva tudi farmakodinamična variabilnost (odziv gostitelja, porazdelitev vrednosti MIK za ciljni patogen v populaciji).
The variability of the data leads to estimates of the withdrawal period for chickens ranging between 4 and 8 days and between 4 and 13 days for turkeys, depending on the individual study.
Zaradi variabilnosti podatkov so bile ocene za karence pri piščancih med 4 in 8 dni, pri puranih pa od 4 do 13 dni, kar je bilo odvisno od posamezne študije.
Add, to all products and amend where applicable:
Dodajte vsem zdravilom in spremenite, kadar je primerno:
Novo mesto, Šmarjeska cesta 6 8501 Novo Mesto Slovenia
Krka d. d. Novo mesto, Šmarješka cesta 6 8501 Novo mesto Slovenija
This would indicate that suitable levels are not reached in lung tissue for efficacy against Mycoplasma spp with an MIC of ≥1 µg/ml.
To kaže, da ustrezne ravni v pljučnem tkivu, ki bi omogočale učinkovitost proti Mycoplasma spp, ≥ 1 µg/ml niso dosežene.
Apart from mutant selection windows, other features of enrofloxacin also promote the selection of resistant strains.
Poleg oken za selekcijo mutant druge lastnosti enrofloksacina prav tako spodbujajo selekcijo odpornih sevov.
1050-047 Lisboa Portugal
1050-047 Lizbona Portugalska
Dunavet-B Zrt.
Madžarska Dunavet-B Zrt.
These aspects include:
Med njimi so:
All but four studies were conducted with an experimental infection of E.coli.
Vse študije razen štirih so bile izvedene z eksperimentalno okužbo E. coli.
48308 Senden-Bosensell Germany
48308 Senden-Bosensell Nemčija
From the public health perspective, the main concern in regards to E.coli is the potential to transfer resistance genes from commensal E.coli in poultry to potentially pathogenic bacterial strains in man.
Z vidika javnega zdravja je glavna težava, povezana z E. coli, potencial za prenos genov za odpornost s komenzalne E. coli pri perutnini na morebitno patogene bakterijske seve pri človeku.
The study did show that one E.coli isolate acquired resistance from the commensal flora of the chicken.
Študija pa je pokazala, da je en izolat E. coli pridobil odpornost iz komenzalne flore piščanca.
Under field conditions, Mycoplasma is typically part of a mixed infection, therefore it can be difficult to demonstrate field efficacy for this indication.
Pri pogojih na terenu je mikoplazma navadno del mešane okužbe, zato je za to stanje težko dokazati učinkovitost na terenu.
It is currently unknown if enrofloxacin usage is associated with CTX-M1 selection and shedding, but ESBL E. coli can also be resistant to fluoroquinolones.
Trenutno ni znano, ali je uporaba enrofloksacina povezana s selekcijo in razsejanjem CTX-M1, vendar je lahko bakterija ESBL-E. coli odporna proti fluorokinolonom.
Resistance has also been reported in Mycoplasma synoviae in the EU.
V EU so poročali tudi o odpornosti pri Mycoplasma synoviae.
Romania S.C. Romvac Company S.A. Şos.
Romunija S.C. Romvac Company S.A. Şos.
CEVA SALUD ANIMAL, Carabela La Niña 12, 5ª 08017 Barcelona Spain
CEVA SALUD ANIMAL, Carabela La Niña 12, 5ª 08017 Barcelona Španija
Although there are some deficiencies in individual clinical studies, sufficient data have been presented to support the indications for M.synoviae and M.gallisepticum in chickens.
Čeprav so posamezne klinične študije nekoliko pomanjkljive, je bilo predloženo dovolj podatkov, ki so podprli indikacije za M. synoviae in M. gallisepticum pri piščancih.
Two studies were submitted to support the indication for A.paragallinarum, one using an experimental infection and one field study.
Predložili sta se dve študiji, ki podpirata indikacijo za A. paragallinarum, v eni je bila uporabljena eksperimentalna okužba, v drugi pa terenska študija.
Smith KE Besser JM Hedberg CW Leano FT Bender JB Wicklund JH Johnson BP Moore KA Osterholm MT and the investigation team (1999) Quinolone resistant Campylobacter jejuni infections in Minnesota 1992-1998.
Smith KE Besser JM Hedberg CW Leano FT Bender JB Wicklund JH Johnson BP Moore KA Osterholm MT in the investigation team (1999) Quinolone resistant Campylobacter jejuni infections in Minnesota 1992-1998.
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