natgillin/translations-raw huggingface dataset:
Always make sure that the entire dose offered has been consumed.
Vedno se prepričajte, da je bil porabljen ves ponujen odmerek.
The results of those studies should be provided to the relevant Authorities for assessment not later than 18 months after the Commission Decision on this referral procedure.
Rezultate teh študij je treba predložiti v oceno ustrezni organom najpozneje 18 mesecev po sklepu Komisije o tem napotitvenem postopku.
Do not use for prophylaxis.
Ne uporabite za profilakso.
Le Carrou et al., 2006.
Le Carrou in drugi, 2006.
Bravničarjeva 13 Ljubljana SLOVENIA
Bravničarjeva 13 Ljubljana SLOVENIJA
The paper states that the high values for 2005-6 were due to the high level of resistance in Spain (24%), which was not included in 1999-2000.
Članek navaja, da so bile visoke vrednosti v letih 2005-2006 posledica visoke stopnje odpornosti v Španiji (24 %), ki ni bila vključena v letih 1999-2000.
This study was conducted using two breeds of chickens, one fast growing and one slower growing, which together cover the range of chickens used for food in Europe.
Ta študija je bila opravljena z dvema pasmama piščancev, eno hitro rastočo in eno počasneje rastočo, ki skupaj pokrivata vrste piščancev, ki se v Evropi uporabljajo za hrano.
Viale Certosa 130 I-20156 Milan ITALY
Viale Certosa 130 I-20156 Milan ITALIJA
3641 RT Mijdrecht THE NETHERLANDS
3641 RT Mijdrecht NIZOZEMSKA
The National Competent Authorities shall ensure that the following condition is fulfilled by the marketing authorisation holders:
Pristojne nacionalne agencije bodo zagotovile, da bodo imetniki dovoljenj za promet izpolnili naslednji pogoj:
Not all indications were included in the product information for all Member States.
V informacije o zdravilu za vse države članice niso vključene vse indikacije.
If no clinical improvement is achieved within 2-3 days, alternative antimicrobial therapy should be considered based on susceptibility testing.
Če v 2 do 3 dneh ni kliničnega izboljšanja, je potrebno izbrati alternativno protimikrobno zdravljenje na podlagi testa občutljivosti.
Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms.
Zdravljenje traja 3-5 zaporednih dni; 5 zaporednih dni pri mešanih okužbah in pri kronično progresivnih oblikah.
However evidence of widespread resistance in the European Union or lack of efficacy of the dose in the treatment of mycoplasmosis is difficult to find.
Vendar je dokaze o razširjeni odpornosti v Evropski uniji ali pomanjkljivi učinkovitosti odmerka pri zdravljenju mikoplazmoze težko najti.
Use only fresh pre-solutions, prepared every day before start of treatment.
Uporabite le sveže pripravljene raztopine, pripravljene vsak dan pred začetkom zdravljenja.
The hazards associated with use of the product are developmental reactions which will not become apparent at the low accidental exposure levels assumed.
Nevarnosti, povezane z uporabo zdravila, so razvojne reakcije, ki niso očitne pri nizkih ravneh nezgodne izpostavljenosti.
This is consistent with the withdrawal period that has been in force in the majority of Member States, in which the product has been authorised for many years.
To je v skladu s karenco, ki je v veljavi v večini držav članic, kjer je zdravilo odobreno že vrsto let.
• Residue depletion studies should be provided for any proposed new dosage regimen.
• Za vsak nov predlagani režim odmerjanja je treba predložiti študije izločanja ostankov.
Resistance has also been reported in Mycoplasma synoviae in the EU.
O odpornosti so poročali tudi pri Mycoplasma synoviae v EU.
Pumping systems should be checked constantly to assure proper medication.
Črpalni sistem je potrebno nenehno preverjati, da se omogoči zadostna medikacija.
For chickens and turkeys, please refer to section 8.
Za piščance in purane glejte poglavje 8.
The product shows good physical and chemical stability over a 48 month storage period, and the data support the proposed shelf life of 48 months without any special storage precautions
Zdravilo ostane v 48 mesecih shranjevanja fizično in kemično stabilno, podatki pa podpirajo predlagani rok uporabnosti 48 mesecev brez posebnih opozoril za shranjevanje.
Calculations in broiler chickens produce the highest exposure of the environment (PECsoil 887 µg/kg).
Izračuni pri pitovnih piščancih dajejo najvišjo izpostavljenost okolja (PECsoil 887 µg/kg).
5, does cover the main risks associated with this product, and can be used to determine user safety warnings to appear on the product information.
5, vendar pokriva glavna tveganja, povezana s tem zdravilom, in se lahko uporabi za določitev opozoril o varnosti uporabnika, ki so del informacij o zdravilu.
Regarding the indications for P. multocida and E. coli, the marketing authorisation holders submitted challenge studies and minimal field data from studies conducted 20 years ago.
V zvezi z indikacijami za P. multocida in E. coli so imetniki dovoljenj za promet z zdravilom predložili provokacijske študije in minimalne podatke s terena iz študij, opravljenih pred 20 leti.
Risks of use of this product have been illustrated in chickens and turkeys by two comprehensive and recent references.
Opis tveganja pri uporabi tega zdravila pri piščancih in puranih je najti v dveh izčrpnih, nedavnih virih.
On 15 October 2010, the United Kingdom sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Baytril 10% oral solution and associated names.
Dne 15. oktobra 2010 je Velika Britanija poslala obvestilo o napotitvi v skladu s členom 34(1) Direktive 2001/82/ES, kakor je bila nazadnje spremenjena, odboru CVMP/Evropski agenciji za zdravila za zdravilo Baytril 10 % peroralna raztopina in povezana imena.
Bayer Sante 220 Avenue De La Recherche 59120 Loos FRANCE
Bayer Sante 220 Avenue De La Recherche 59120 Loos FRANCIJA
The marketing authorisation holders have provided a user risk assessment which, although not fully compliant with the current guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)
Imetniki dovoljenj za promet z zdravilom so predložili oceno tveganja za uporabnika, ki sicer ni povsem v skladu s trenutnimi smernicami o varnosti uporabnika pri farmacevtskih izdelkih za veterinarsko medicino (EMA/CVMP/543/03-Rev.1)
By limiting the use of the product, these warnings are intended to minimise the potential impact on human and animal health from antimicrobial resistance.
Namen teh opozoril je omejiti uporabo zdravila in tako zmanjšati možni učinek na zdravje ljudi in živali zaradi protimikrobne odpornosti.
Available online at www.efsa.europa.eu/efsajournal de Jong A, Stephan B, Silley P.(2012).Fluoroquinolone resistance in E coli and Salmonella from healthy livestock and poultry in the EU.
Na voljo na spletnem naslovu www.efsa.europa.eu/efsajournal de Jong A, Stephan B, Silley P.(2012).Fluoroquinolone resistance in E coli and Salmonella from healthy livestock and poultry in the EU.
Since only MIC and minimal field data relating to a mixed infection are provided for the indication of Bordetella, this indication should not be included on the product information.
Ker so za indikacijo Bordetella predloženi samo MIK in minimalni podatki s terena v zvezi z mešano okužbo, se ta indikacija ne sme vključiti v informacije o zdravilu.
BAYER PORTUGAL, SA Rua Quinta do Pinheiro, 5 2794-003 Carnaxide PORTUGAL
BAYER PORTUGAL, SA Rua Quinta do Pinheiro, 5 2794-003 Carnaxide PORTUGALSKA
User safety warnings are included on the product information.
V informacije o zdravilu so vključena opozorila o varnosti uporabnika.
Any medicated water remaining after 24 hours after preparation must be discarded.
Vsi ostanki medicirane vode, starejši od 24 ur po pripravi, se morajo zavreči.
<Date of last renewal:> <{DD/MM/YYYY}><{DD month YYYY}>.
<Datum zadnjega podaljšanja dovoljenja za promet :> <{DD/MM/YYYY}><{DD month YYYY}>.
Empty the water system and fill it with medicated water before starting the treatment.
Pred začetkom zdravljenja izpraznite vodni sistem in ga napolnite z medicirano vodo.
CVMP guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/03/WC500077971.pdf
Smernice CVMP o varnosti uporabnikov pri farmacevtskih izdelkih za veterinarsko medicino (EMA/CVMP/543/03-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/03/WC500077971.pdf
A high mean volume of distribution (5 L/kg) indicates good tissue penetration of enrofloxacin.
Visok povprečni volumen porazdelitve (5 L/kg) kaže na dobro penetracijo enroflokacina v tkiva.
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.
Evropska agencija za varnost hrane in Evropski center za preprečevanje in obvladovanje bolezni; Zbirno poročilo Evropske unije o odpornosti zoonoz in indikatorskih bakterij proti antibiotikom pri ljudeh, živalih in v hrani v letu 2010 (European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010).
• Do not eat, drink or smoke whilst using the product.
• Med dajanjem zdravila ne jejte, pijte ali kadite.
The containers are provided with a graduated polypropylene measuring cup.
Vsebniki so opremljeni z merilno polipropilensko čašo.
Medicated water should be made up on a daily basis.
Medicirano vodo pripravljamo dnevno.
The drinking water must be medicated throughout the treatment period, and no other water source should be available.
Pitna voda mora biti medicirana ves čas zdravljenja, na voljo ne sme biti noben drug vir pitne vode .
Environmental Risk Assessment
Ocena tveganja za okolje
There are not enough data to either determine the optimum dose rate for treatment or to propose an alternative dose rate for poultry, and new studies are required.
Podatkov ni dovolj, da bi lahko ugotovili optimalni odmerek za zdravljenje ali predlagali alternativni odmerek za perutnino, zato so potrebne nove študije.
All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Vsi mehanizmi vodijo do zmanjšane občutljivosti bakterij na fluorokinolone.
The date of the first withdrawal should be recorded on the label.
Datum prvega umika mora biti onačen na ovojnini.
Card box (100 ml bottle)
Kartonska škatla (100 ml plastenka)
This is also consistent with the dose for this species/indication stated in the SPC for other comparable EU authorised products.
To je tudi v skladu z odmerkom za to vrsto/indikacijo, navedeno v povzetku glavnih značilnosti zdravila za druga primerljiva zdravila, odobrena v EU.
Concerns were raised by CVMP regarding references highlighting emergence of resistant strains of M. synoviae both under experimental conditions (Le Carrou et al
Odbor CVMP je izrazil zaskrbljenost glede virov, ki izpostavljajo pojav odpornih sevov M. synoviae v eksperimentalnih pogojih (Le Carrou in drugi
Protein binding in poultry is approximately 25 %.
Vezava na proteine je pri peutnini približno 25%.
Provided this PECsoil is not exceeded, exposure of the environment to enrofloxacin will not increase and the product is not expected to pose a risk for the environment.
Če vrednost PECsoil ni prekoračena, se izpostavljenost okolja enrofloksacinu ne poveča in ni pričakovati, da bi zdravilo predstavljalo tveganje za okolje.
The veterinary medicinal product has been appropriately formulated and the harmonised shelf life is appropriate to ensure that quality is maintained during use.
Zdravilo za uporabo v veterinarski medicini je ustrezno formulirano, usklajen rok uporabnosti pa je ustrezen za ohranjanje kakovosti med uporabo.
Lot: {number}
Lot: {številka}
The first time point at which all residues were below their respective maximum residue limits in the slower-growing birds was at 3 days after final treatment, one day after the faster-growing birds.
Prva časovna točka, pri kateri so bili pri počasi rastočih pticah vsi ostanki pod največjimi dovoljenimi mejami, je bila 3 dni po zadnjem zdravljenju, kar je en dan več kot pri hitro rastočih pticah.
Therefore, and taking account of the scope of this Article 34 referral, the indication can be retained in the harmonised SPC.
Zaradi tega in ob upoštevanju obsega te napotitve v skladu s členom 34 se lahko indikacija ohrani v usklajenem povzetku glavnih značilnosti zdravila.
Rabbits were included as a target species in the product information for Italy, only.
Kunci so bili v informacije o zdravilu kot ciljna vrsta vključeni samo v Italiji.
“Product name” (to be completed nationally) may be put directly into the header tank or introduced via a water proportioner pump.
“Ime zdravila” (se dopolni nacionalno) se lahko daje neposredno v rezervoar za vodo ali preko vodne odmerne črpalke.
To be completed nationally <Date of first authorisation:> <{DD/MM/YYYY}><{DD month YYYY}>.
Se dopolni l-nacionalno <Datum prvega dovoljenja za promet:> <{DD/MM/YYYY}><{DD month YYYY}>.
The data provided to show the rate of residue depletion in chickens were also not to current standards, but they were considered to be adequate, for the purposes of this procedure, to set a 3-day meat withdrawal period for chickens.
Predloženi podatki kažejo, da stopnje izločanja ostankov pri piščancih tudi niso v skladu s trenutnimi standardi, vendar za namene tega postopka zadoščajo za določitev 3-dnevne karence za piščančje meso.
1, 2006) and from commercial poultry in the Netherlands (Landman
1, 2006) in iz komercialne vzreje perutnine na
Avoid contact with skin and eyes.
Izogibajte se stiku s kožo in očmi.
User risk assessment
Ocena tveganja za uporabnika
Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Navzkrižna odpornost v skupini fluorokinolonskih protimikrobnih sredstev je pogosta.
Concentrations in target tissues like lungs, liver, kidney, intestine and muscle tissue, exceed plasma concentrations by far.
Koncentracije v ciljnih organih kot so pljuča, jetra, ledvice, črevesno in mišično tkivo, močno presegajo plazemsko koncentracijo.
1831 Diegem (Machelen) BELGIUM
Mommaertslaan 14 1831 Diegem (Machelen) BELGIJA
However according to the EFSA/ECDC report (2012) resistance to ciprofloxacin in indicator E. coli isolates taken from chickens is described as moderate to high at a rate of 47%, although in this report, the resistance rate is based on epidemiological cut-off values for non-pathogenic strains.
Vendar pa je v skladu s poročilom EFSA/ECDC (2012) odpornost proti ciprofloksacinu pri indikatorskih izolatih E. coli iz piščancev opisana kot zmerna do visoka s stopnjo 47 %, čeprav v tem poročilu stopnja odpornosti temelji na epidemioloških mejnih vrednostih za nepatogene seve.
Some concerns remain in relation to the dosing regimens for all species, and whether they are optimal in terms of minimising the risk for development of antimicrobial resistance.
V zvezi z režimi odmerjanja ostaja nekaj pomislekov za vse vrste, poleg vprašanj, ali so optimalni v smislu zmanjšanja tveganja za razvoj protimikrobne odpornosti.
The marketing authorisation holders agreed to delete the following indications from the product information either due to paucity of supporting data and/or because the indications were not consistent with responsible use on fluoroquinolones: Salmonella, Streptococcus spp, Staphylococcus spp, Klebsiella, Erysipelothrix rhusiopathae.
Imetniki dovoljenj za promet z zdravilom so se strinjali glede črtanja naslednjih indikacij iz informacij o zdravilu zaradi nezadostnih podpornih podatkov in/ali zato, ker indikacije niso bile v skladu z odgovorno uporabo fluorokinolonov: Salmonella, Streptococcus spp, Staphylococcus spp, Klebsiella, Erysipelothrix rhusiopathae.
Do not use this veterinary medicinal product after the expiry date which is stated on the packaging.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
The United Kingdom referred the issue due to divergent national decisions having been taken by EU countries resulting in discrepancies in the product information for Baytril 10% oral solution and associated names.
Velika Britanija je zadevo napotila zaradi različnih nacionalnih odločitev v državah EU, ki so povzročile neskladnosti v informacijah o zdravilu Baytril 10 % peroralna raztopina in povezanih imenih.
• the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holders and considered all the overall submitted data;
• odbor CVMP je pregledal povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih predlagajo imetniki dovoljenj za promet, in upošteval vse predložene podatke;
Whenever possible fluoroquinolones should only be used based on susceptibility testing.
Če je možno, flourokinolone uporabite le na osnovi preskusa občutljivosti.
Overall summary of the scientific evaluation of Baytril 10% oral solution and associated names (see annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Baytril 10 % peroralna raztopina in povezanih imen (glejte Prilogo I)
The medicated water should be made up fresh each day just before it is offered to the animals.
Medicirana voda mora biti pripravljena sveže vsak dan, preden je na voljo živalim.
Official and local antimicrobial policies should be taken into account when the product is used.
Upoštevajte uradno in lokalno doktrino uporabe protimikrobnih zdravil.
Clinical resistance of E. coli in chickens to ciprofloxacin was 1.9% in 1999-2000 and increased through 2002-3 to 5.9% in 2005-6.
Klinična odpornost E. coli proti ciprofloksacinu pri piščancih je bila v letih 1999-2000 1,9 %, v letih 2002-2003 pa se je večala, tako da je v letih 2005-2006 dosegla 5,9 %.
Bottle or canister
Plastenka ali kanister
Determine the bodyweight of the birds as accurately as possible in order to avoid underdosing.
Telesno maso živali določite kar se da natančno, da preprečite premajhno odmerjanje.
Do not eat, drink or smoke whilst using the product.
Med dajanjem zdravila ne jejte, pijte ali kadite.
The proposed SPC contains the warnings regarding prudent use of fluoroquinolones in food producing animals in line with the CVMP reflection paper 2006
Predlagani povzetek glavnih značilnosti zdravila vsebuje opozorila glede preudarne uporabe fluorokinolonov pri živalih za proizvodnjo hrane, v skladu s študijo odbora CVMP iz leta 2006
The references concluded that administration of the proposed dose rate was safe for the proposed dose duration.
V virih je navedeno, da je uporaba predlaganega odmerka pri predlaganem trajanju odmerjanja varna.
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 2005-6.
Stopnje zmanjšane občutljivosti E. coli za ciprofloksacin na podlagi epidemiološke mejne vrednosti 0,06 mg/l so bile 19,3 % v letih 1999-2000 in 33,5 % v letih 2005-2006.
Because the data available was inconclusive, and furthermore because the CVMP agreed that the dose for this species should be increased, as a pragmatic approach it is proposed to retain the current 15-day withdrawal period as this will ensure consumer safety, considering the rapid depletion shown in poultry and rabbits.
Ker so bili razpoložljivi podatki nedokončni in ker se je odbor CVMP strinjal s povečanjem odmerka za to vrsto, je kot pragmatični pristop predlagano, da se za zagotovitev varnosti uporabnikov ohrani trenutna 15dnevna karenca, ob upoštevanju hitrega izločanja pri perutnini in kuncih.
Via the drinking water.
Dajanje v pitno vodo.
Enrofloxacin is eliminated from the body at a half-life of 6 hours.
Enrofloksacin se izloča iz organizma z razpolovno dobo 6 ur.
A shorter or lower dose regimen than the current 10 mg/kg for 5 days needs to be substantiated by new clinical data.
Režim odmerjanja, ki je krajši ali uporablja manjši odmerek od trenutnega režima 10 mg/kg v trajanju 5 dni, je treba podpreti z novimi kliničnimi podatki.
Maximum plasma concentrations of 2 mg/L are reached within 1.5 hours after a single bolus dose rate of 10 mg/kg body weight with a total systemic availability of 14.4 mg·hr/L.
Največje koncentracije v serumu v vrednosti 2 mg/L dosežemo v 1,5 uri po dajanju enkratnega odmerka 10 mg enrofloksacina na kg telesne mase, s celotno sistemsko razpoložljivostjo 14,4 mg hr/L.
In studies where the dose could be calculated in mg/kg, although a dose of approximately 10 mg/kg bodyweight was effective as metaphylaxis it appeared that a higher dose was more effective for treatment of E. coli.
V študijah, kjer je bilo mogoče odmerek izračunati v mg/kg, čeprav je bil odmerek približno 10 mg/kg telesne mase učinkovit kot metafilaksa, je kazalo, da je večji odmerek učinkovitejši za zdravljenje okužb z E. coli.
The overall benefit-risk balance for this product is deemed positive subject to the recommended changes in the product information (see annex III) and subject to condition affecting the marketing authorisations (see annex IV).
Splošno razmerje med koristmi in tveganji tega zdravila tako velja za pozitivno, ob upoštevanju predlaganih sprememb informacij o zdravilu (glejte poglavje III) in pogojev, ki zadevajo dovoljenje za promet z zdravilom (glejte Prilogo IV).
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 za uporabo pri perutnini, se je pojavilo široko razširjeno zmanjšanje odpornosti E. coli na fluorokinolone in pojav odpornih mikroorganizmov.
• User safety warnings;
• varnostne ukrepe za uporabnika,
Enrofloxacin administered via drinking water to poultry is rapidly and very well absorbed with a bioavailability of approx. 90 %.
Enrofloksacin, ki ga dajemo v pitno vodo perutnini, se v prebavilih hitro in zelo dobro absorbira, z biološko razpoložljivostjo približno 90 %.
• The marketing authorisation holders should substantiate the dosing regimen in rabbits taking into account the current MIC distribution for the target pathogens, the variability in pharmacokinetics resulting from administration of enrofloxacin via the drinking water to groups of rabbits under field conditions and with the goal to ensure sustainable effective treatment.
• Imetniki dovoljenj za promet z zdravilom morajo utemeljiti režim odmerjanja pri kuncih, ob upoštevanju trenutne porazdelitve MIK za ciljne povzročitelje bolezni in razlik v farmakokinetiki zaradi dajanja enrofloksacina v pitni vodi skupinam kuncev pod pogoji na terenu ter z namenom zagotovitve trajnostno učinkovitega zdravljenja.
The marketing authorisation holders have conducted a basic PK/PD analysis regarding E. coli, but no consideration has been given to an antimutant dosing strategy or to the potential to select for resistant food-borne organisms of significance to public health (Campylobacter, Salmonella).
Imetniki dovoljenj za promet z zdravilom so izvedli osnovno farmakokinetično in farmakodinamično analizo za E. coli, vendar niso upoštevali strategije odmerjanja proti mutacijam ali možnosti izbire odpornega organizma, ki se prenaša s hrano, pomembnega za zdravje ljudi (Campylobacter, Salmonella).
Total number of birds x Average body weight in kg x 0.1 = Total volume (ml) per day
Skupno število živali x povprečna telesna masa v kg x 0.1 = Skupna količina (v ml) na dan
• Avoid contact with skin and eyes.
• Izogibajte se stiku s kožo in očmi.
Enrofloxacin does not have a maximum residue limit for eggs, and therefore birds laying eggs for human consumption must not be treated with Baytril 10% oral solution and its associated names.
Za enrofloksacin ni največjih dovoljenih mej za jajca, zato ptic, ki nesejo jajca za prehrano ljudi, ni dovoljeno zdraviti z zdravilom Baytril 10 % peroralna raztopina in povezanimi imeni.
Turkeys: 8 days
Purani: 8 dni
Bottles of 100, 500 and 1,000 ml or canister of 5,000 ml.
Plastenke s 100, 500 in 1,000 ml ali kanister s 5,000 ml.