FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Belgium BAYER SA-NV J.E.
Slovenian: BAYER SA-NV J.E.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: • User safety warnings;
Slovenian: • varnostne ukrepe za uporabnika,
English: Enrofloxacin administered via drinking water to poultry is rapidly and very well absorbed with a bioavailability of approx. 90 %.
Slovenian: Enrofloksacin, ki ga dajemo v pitno vodo perutnini, se v prebavilih hitro in zelo dobro absorbira, z biološko razpoložljivostjo približno 90 %.
English: • 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.
Slovenian: • 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.
English: 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).
Slovenian: 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).
English: Netherlands Bayer B.V.
Slovenian: Nizozemska Bayer B.V.
English: Total number of birds x Average body weight in kg x 0.1 = Total volume (ml) per day
Slovenian: Skupno število živali x povprečna telesna masa v kg x 0.1 = Skupna količina (v ml) na dan
English: • Avoid contact with skin and eyes.
Slovenian: • Izogibajte se stiku s kožo in očmi.
English: 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.
Slovenian: 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.
English: Turkeys: 8 days
Slovenian: Purani: 8 dni
English: Bottles of 100, 500 and 1,000 ml or canister of 5,000 ml.
Slovenian: Plastenke s 100, 500 in 1,000 ml ali kanister s 5,000 ml.
English: There are not sufficient data available to set a scientifically-derived withdrawal period in rabbits, but the limited data available show that the first time point at which all residues were below the MRLs set by the CVMP was at 2 days after the final treatment.
Slovenian: Podatkov za določitev karence pri kuncih na podlagi znanstvenih izsledkov ni dovolj, vendar pa razpoložljivi podatki kažejo, da je prva časovna točka, pri kateri so bili vsi ostanki pod največjimi dovoljenimi mejami, kot jih je določil odbor CVMP, 2 dni po zadnjem zdravljenju.
English: 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.
Slovenian: Poročali so, da odpornost na fluorokinolone izhaja iz petih virov: (i) točkovne mutacije genov za kodiranje DNK giraze in / ali topoizomeraze 4IV, ki vodi do sprememb posameznega encima, (ii) sprememb prepustnosti za zdravilo pri Gram-negativnih bakterijah, (iii) mehanizma efluksa, (iv) odpornosti, vezani na plazmide in (v) proteinov, ki zaščitijo girazo.
English: Solution for use in drinking water.
Slovenian: Peroralna raztopina za uporabo v pitni vodi.
English: In poultry enrofloxacin is poorly metabolized to its active metabolite ciprofloxacin (approximately 5 %).
Slovenian: Pri perutnini se enrofloksacin slabše presnovi v njegov metabolit ciprofloksacin (približno 5 %).
English: The risks for the environment have been assessed previously for a dose of 10 mg/kg bodyweight for 10 consecutive days in broiler chickens.
Slovenian: Tveganje za okolje so predhodno ocenili za uporabo odmerka 10 mg/kg telesne mase v 10 zaporednih dneh pri pitovnih piščancih.
English: The marketing authorisation holders provided a basic PK/PD analysis for enrofloxacin/E.
Slovenian: Imetniki dovoljenj za promet z zdravilom so predložili osnovno farmakokinetično in farmakodinamično analizo za enrofloksacin/E.
English: Enrofloxacin is eliminated from the body with a total body clearance of 10.3 mL/min·kg.
Slovenian: Enrofloksacin se izloča iz organizma s skupnim telesnim očistkom 10.3 mL/min·kg.
English: 51368 Leverkusen GERMANY
Slovenian: 51368 Leverkusen NEMČIJA
English: The results of the additional studies submitted for turkeys generally supported the proposed dose rate of 10 mg/kg bodyweight.
Slovenian: Rezultati dodatnih predloženih študij za purane večinoma podpirajo predlagani odmerek 10 mg/kg telesne mase.
English: The CVMP has proposed further amendments to the warnings regarding resistance in section 4.5 of the SPC (Special precautions for use).
Slovenian: Odbor CVMP je predlagal dodatne spremembe opozoril glede odpornosti v poglavju 4.5 povzetka glavnih značilnosti zdravila (Posebni previdnostni ukrepi).
English: In addition, because of the concern that underdosing might encourage the development of antimicrobial resistance, the CVMP agreed to accept an increase in the dose to 10 mg/kg bodyweight during 5 days for this species in order to maintain this minor species in the product information.
Slovenian: Odbor CVMP se je poleg tega zaradi skrbi, da bi premajhno odmerjanje lahko pospešilo razvoj protimikrobne odpornosti, strinjal, da pri tej vrsti sprejme povečanje odmerka na 10 mg/kg telesne mase za 5-dnevno zdravljenje, da se ta manj pomembna vrsta lahko ohrani v informacijah o zdravilu.
English: <Manufacturer responsible for batch release:>
Slovenian: <Izdelovalec, odgovoren za sprostitev serije:>
English: Enrofloxacin is active against many Gram-negative bacteria, against Gram-positive bacteria and Mycoplasma spp.
Slovenian: Enrofloksacin deluje na številne po Gramu negativne bakterije, po Gramu pozitivne bakterije in Mycoplasmo spp.
English: coli but this was equivocally supportive of the 10 mg/kg bodyweight dose rate and also suggested that a higher dose might be preferable.
Slovenian: coli, vendar je ta nezanesljivo podprla odmerek 10 mg/kg telesne mase in hkrati predlagala, da bi bil primernejši večji odmerek.
English: The exposure of the environment from the use of the product in chickens (PECsoil 887 µg/kg) is greater than the exposure from the treatment of rabbits at the new proposed dose rate of 10 mg/kg during 5 days (PECsoil 361 µg/kg).
Slovenian: uporabe zdravila pri piščancih (PECsoil 887 µg/kg) je večja kot izpostavljenost pri zdravljenju kuncev z novim predlaganim odmerkom 10 mg/kg, ki traja 5 dni (PECsoil 361 µg/kg).
English: Potassium hydroxide Purified water.
Slovenian: Benzilalkohol Kalijev hidroksid Prečiščena voda
English: According to the references submitted by the marketing authorisation holders, resistance rates in E. coli from chickens and turkeys are reported as low.
Slovenian: V skladu z viri, ki so jih predložili imetniki dovoljenj za promet z zdravilom, so poročane stopnje odpornosti E. coli pri piščancih in puranih nizke.
English: Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Slovenian: Flourokiolone uporabite le za zdravljenje kliničnih stanj, pri katerih je bil opažen ali se pričakuje slab odziv na zdravljenje z drugimi vrstami protimikrobnih zdravil.
English: The simultaneous application of substances containing aluminium or magnesium can impair the absorption of enrofloxacin.
Slovenian: Sočasno dajanje pripravkov, ki vsebujejo magnezijeve ali aluminijeve soli, lahko zmanjša absorpcijo enrofloksacina.
English: In this paper, clinical resistance was assessed against the Clinical Laboratory and Standards Institute (CLSI) breakpoint for ciprofloxacin of ≥ 4 mg/l.
Slovenian: V tem članku so klinično odpornost ovrednotili glede na mejno vrednost Kliničnega laboratorija in inštituta za standarde (Clinical Laboratory and Standards Institute, CLSI) za ciprofloksacin, ≥ 4 mg/l.
English: The challenge studies suggested that a dose of 10 mg/kg bodyweight would be more effective than the proposed 5 mg/kg bodyweight, especially when treating acute cases.
Slovenian: Provokacijske študije so nakazovale, da je odmerek 10 mg/kg telesne mase učinkovitejši od predlaganega odmerka 5 mg/kg telesne mase, zlasti za zdravljenje akutnih primerov.
English: If dosed as continuous drinking water medication (multiple dosing) steady-state concentrations of 0.5 mg (turkeys) to 0.8 mg (chicken) enrofloxacin per litre are achieved.
Slovenian: Če je odmerjanje kontinuirano dajanje zdravila v pitno vodo (večkratno odmerjanje) stalno, se doseže raven koncentracij od 0.5 mg (pri puranih) do 0.8 mg (pri piščancih) enrofloksacina na liter.
English: From the data submitted however, it is not possible to determine the optimal dose rate for treatment of Escherichia coli in either chickens or turkeys.
Slovenian: Vendar pa iz predloženih podatkov ni mogoče ugotoviti optimalnega odmerka za zdravljenje okužb z Escherichia coli niti za piščance niti za purane.
English: A warning in relation to the potential effects of overdosing of fluoroquinolones on cartilage during the growth phase is included in section 4.10 of the SPC (Overdose).
Slovenian: Opozorilo o možnih učinkih prevelikega odmerjanja fluorokinolonov na hrustanec med rastjo je vključeno v poglavje 4.10 povzetka glavnih značilnosti zdravila (Preveliko odmerjanje).
English: For the treatment infectious diseases due to Pasteurella multocida and bacterial enteritis due to infection with E. coli.
Slovenian: Za zdravljenje okužb, ki jih povzroča Pasteurella multocida in za zdravljenje bakterijskega enteritisa, ki ga povzroča E. coli.
English: Initially, both strands of the DNA double helix are cleaved.
Slovenian: Najprej se razcepi dvojna vijačnica DNK.
English: In doing this, CVMP recognises that an effective treatment should be kept available for E. coli, but at a future date new data will have to be generated to optimise the dose regimen for all enrofloxacin products administered orally to poultry.
Slovenian: S tem odbor CVMP priznava, da je treba ohraniti razpoložljivost učinkovitega zdravljenja okužb z E. coli, vendar bodo v prihodnje potrebni novi podatki za optimiranje režima odmerjanja vseh zdravil z enrofloksacinom, ki se perutnini dajejo peroralno.
English: Although some concern remains that the dose regimen may not be optimal for the treatment of E. coli, and with regard to limiting the risk for the development of antimicrobial resistance, it is recognised that enrofloxacin is critically important for the treatment of colibacillosis in poultry.
Slovenian: Kljub preostalim pomislekom, da morda režim odmerjanja ni optimalen za zdravljenje okužb z E. coli, in ob upoštevanju omejitve tveganja za razvoj protimikrobne odpornosti, se priznava kritičen pomen enrofloksacina za zdravljenje kolibaciloze pri perutnini.
English: The product is well tolerated by the target species, and presents a low risk for users and the environment when used in accordance with the harmonised warnings included in the SPC.
Slovenian: Ciljna živalska vrsta zdravilo dobro prenaša, za uporabnike in okolje pa predstavlja majhno tveganje, če se uporablja v skladu z usklajenimi opozorili, vključenimi v povzetek glavnih značilnosti zdravila.
English: This study was also considered to be adequate to be used to set a 3-day withdrawal period for turkeys, by extrapolation from the chicken data.
Slovenian: Ta študija je zadoščala za določitev 3-dnevne karence za purane z ekstrapolacijo podatkov za piščance.
English: The marketing authorisation holders confirmed that no marketing authorisation for the product relating to use in chickens or turkeys has been withdrawn, refused, revoked or suspended in any Member State.
Slovenian: Imetnik dovoljenja za promet z zdravilom je potrdil, da nobeno dovoljenje za promet z zdravilom v zvezi z uporabo pri piščancih ali puranih ni bilo odvzeto, zavrnjeno, preklicano ali začasno umaknjeno v nobeni od držav članic.
English: However, it has to be considered that as E coli from poultry are often resistant to first line antimicrobials, fluoroquinolones are recognised as veterinary critically important antimicrobials in the treatment of colibacillosis septicaemia and chronic respiratory disease in this species and it is important to maintain this indication on the SPC.
Slovenian: Vendar pa je treba upoštevati, da je bakterija E coli pri perutnini pogosto odporna na protimikrobna zdravila prve izbire, fluorokinoloni pa so v veterini kritično pomembna protimikrobna zdravila za zdravljenje septikemije zaradi kolibaciloze in kroničnih bolezni dihal pri tej vrsti, zato je pomembno, da se ta indikacija v povzetku glavnih značilnosti zdravila ohrani.
English: Discard unused material.
Slovenian: Neuporabljen material zavržemo.
English: However, as there are limited data available for treatment of E. coli in this minor species, and extrapolation is made from the data provided for chickens, some concerns still remain.
Slovenian: Vendar pa so za zdravljenje okužb z E. coli pri teh manj pomembnih vrstah podatki omejeni in ekstrapolirani iz podatkov, predloženih za piščance, zato ostaja nekaj pomislekov.
English: 5,000 ml HDPE canister with an aluminium/HDPE seal and an HDPE screw closure.
Slovenian: 5,000 ml HDPE kanister z aluminijevim/HDPE pečatom in HDPE navojno zaporko.
English: The marketing authorisation holders confirmed that no marketing authorisation for the product relating to use in rabbits has been withdrawn, refused, revoked or suspended in any Member State.
Slovenian: Imetniki dovoljenj za promet z zdravilom so potrdili, da nobeno dovoljenje za promet z zdravilom v zvezi z uporabo pri kuncih ni bilo odvzeto, zavrnjeno, preklicano ali začasno umaknjeno v nobeni od držav članic.
English: Do not use in the case of known hypersensitivity to the active substance, other (fluoro)quinolones or to any of the excipients.
Slovenian: Ne uporabite v primerih znane preobčutljivosti na zdravilno učinkovino, ostale (fluoro)kinolone ali na katerokoli pomožno snov.
English: In this situation, as the rabbit is a minor species, the assessment for broilers covers the use of the product in rabbits and the risk assessment can stop at Phase I.
Slovenian: Ker so kunci manj pomembna vrsta, krije v tem primeru ocena za pitovne piščance uporabo zdravila pri kuncih, vrednotenje tveganja pa se lahko ustavi v 1. fazi.
English: Replication forks and translational complexes cannot proceed beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and mRNA synthesis triggers events resulting in a rapid, drug concentration-dependent killing of pathogenic bacteria.
Slovenian: Replikacijske vilice in translacijski kompleksikompleksa ne morejo nadaljevati preko nastalega encimsko- DNK-fluorokinolonskega kompleksa; zaviranje sinteze DNK in mRNK sproži dogodke, katerih posledica je hitro, od koncentracije zdravila odvisno ubijanje patogenih bakterij.
English: The marketing authorisation holders have not provided sufficient residues depletion data to allow a scientifically determined withdrawal period to be set for either turkeys or rabbits.
Slovenian: Imetniki dovoljenj za promet z zdravilom niso predložili dovolj podatkov o izločanju ostankov, da bi omogočili znanstveno določitev karence za purane ali kunce.
English: The data package supports an in-use shelf life of 12 weeks and an in-use shelf life after dilution of 24 hours.
Slovenian: Razpoložljivi podatki podpirajo rok uporabnosti med uporabo 12 tednov in rok uporabnosti po razredčitvi 24 ur.
English: Baytril 10% oral solution and associated names are veterinary medicinal products authorised for use the target species chickens, turkeys and rabbits for treatment of the respiratory tract and of the digestive tract infections caused by identified bacteria susceptible to enrofloxacin.
Slovenian: Zdravilo Baytril 10 % peroralna raztopina in povezana zdravila so zdravilo za uporabo v veterinarski medicini, ki je odobreno za ciljne vrste piščance, purane in kunce za zdravljenje okužb dihal in prebavil, ki jih povzroča identificirana bakterija, občutljiva za enrofloksacin.
English: Target animal safety
Slovenian: Varnost ciljnih živalskih vrst
English: Baytril 10% oral solution at a dose rate of 100 ppm (approximately 10 mg/kg) for 6 days and repeating after a 3 day interval was shown to be safe to use in rabbits aged 30 days, in does at mating and 15 days after mating and when does were lactating.
Slovenian: Uporaba zdravila Baytril 10 % peroralna raztopina v odmerkih 100 ppm (približno 10 mg/kg), ki je trajala 6 dni, s ponovitvijo po 3-dnevnem premoru se je izkazala za varno pri kuncih, starih 30 dni, pri kunkah med paritvijo in 15 dni po paritvi ter med laktacijo.
English: However, it was acknowledged that the data supporting the increased dose regimen are weak, and therefore a condition should be imposed to the marketing authorisations requiring new data to substantiate the dose regimen for this species.
Slovenian: Vendar pa je bilo potrjeno tudi, da so podatki, ki podpirajo režim z večjim odmerkom, nezanesljivi, zato je treba dovoljenja za promet z zdravilom pogojevati s pridobitvijo novih podatkov za utemeljitev režima odmerjanja za to vrsto.
English: Therefore, and considering the context of this Article 34 referral which is to harmonise the SPCs, CVMP proposed to harmonise to the highest dose rate of enrofloxacin of 10 mg/kg for 3-5 days in both chickens and turkeys, which is also that approved in the majority of Member States.
Slovenian: Odbor CVMP je zaradi tega in ob upoštevanju okvira te napotitve v skladu s členom 34, tj. uskladitve povzetkov glavnih značilnosti zdravila, predlagal uskladitev največjega odmerka enrofloksacina na 10 mg/kg za 3-5 dni za piščance in purane, kar je odobreno tudi v večini držav članic.
English: Regarding the indications for P. multocida and E. coli for rabbits, it was agreed that with an increase to the dose, the benefit-risk for this minor species would remain positive, however a condition should be imposed to the marketing authorisations requiring new data to substantiate the dose regimen for this species.
Slovenian: V zvezi z indikacijo za P. multocida in E. coli pri kuncih je bilo dogovorjeno, da ostane z večjim odmerkom razmerje med koristmi in tveganji pri tej manj pomembni vrsti pozitivno, vendar je pogoj za dovoljenje za promet z zdravilom, da se pridobijo novi podatki, ki bodo podprli režim odmerjanja za to vrsto.
English: In chickens, the EU studies submitted are approximately 25 years old, involve experimental infections only and were conducted when the Minimum Inhibitory
Slovenian: Predložene študije EU pri piščancih so stare približno 25 let, vključujejo samo eksperimentalne okužbe in so bile izvedene, ko je bila minimalna inhibitorna koncentracija (MIK) E. coli bistveno nižja od današnje MIK za E. coli.
English: 100 ml, 500 ml and 1,000 ml high density polyethylene (HDPE) bottles with an HDPE insert and a polypropylene screw closure.
Slovenian: 100 ml, 500 ml in 1,000 ml plastenke iz polietilena visoke gostote (HDPE) s HDPE vložkom in s polipropilensko navojno zaporko.
English: BAYER HEALTH CARE AG 51368 Leverkusen GERMANY
Slovenian: BAYER HEALTH CARE AG 51368 Leverkusen NEMČIJA
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, withdrawal period, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, karenc, imetnikov dovoljenj za promet z zdravili
English: At doses ≥ 50 mg/kg bodyweight/day administered for 5 days there was histological evidence of a detrimental effect on articular cartilage in broilers, but leg lesions were only clinically apparent in chickens and turkeys at doses > 100 mg/kg administered for ≥ 5 days.
Slovenian: Pri odmerkih ≥ 50 mg/kg telesne mase/dan, dajanih 5 dni, so odkrili histološke dokaze o škodljivem učinku na sklepni hrustanec pitovnih piščancev, vendar so bile lezije nog pri piščancih in puranih klinično vidne samo pri odmerkih > 100 mg/kg, dajanih ≥ 5 dni.
English: Please read package leaflet carefully before use.
Slovenian: Pred uporabo natančno preberite navodilo za uporabo.
English: Target species, indications and posology
Slovenian: Ciljne vrste, indikacija in odmerjanje
English: Although most Member States had a dose rate of 10 mg/kg for chickens and turkeys, it varied between from 2.5 mg/kg bodyweight to 10 mg/kg bodyweight for duration between 3 to 10 days.
Slovenian: Čeprav je bil v večini držav članic priporočen odmerek 10 mg/kg za piščance in purane, je bil razpon odmerkov za trajanje zdravljenja od 3 do 10 dni od 2,5 mg/kg telesne mase do 10 mg/kg telesne mase.
English: <Marketing authorisation holder <and manufacturer responsible for batch release>:
Slovenian: <Imetnik dovoljenja za promet z zdravilom <in izdelovalec, odgovoren za sprostitev serije >>:
English: Shelf-life after first opening the immediate packaging: 12 weeks.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 12 tednov.
English: Bayer Vital GmbH 51368 Leverkusen GERMANY
Slovenian: Bayer Vital GmbH 51368 Leverkusen NEMČIJA
English: One ml of “Product name” (to be completed nationally) contains:
Slovenian: En ml “Ime zdravila” (se dopolni nacionalno) vsebuje:
English: • the CVMP considered the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet;
Slovenian: • Odbor CVMP je upošteval namen napotitve, tj. uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo,
English: Wash hands and exposed skin after use.
Slovenian: Po uporabi si umijte roke.
English: Baytril 10% oral solution and associated names contain 100 mg enrofloxacin per ml oral solution for use in drinking water.
Slovenian: Zdravilo Baytril 10 % peroralna raztopina in povezana imena vsebuje 100 mg enrofloksacina na mililiter peroralne raztopine za uporabo v pitni vodi.
English: To be completed nationally
Slovenian: Se dopolni nacionalno
English: Satisfactory withdrawal periods have been set to provide assurance of consumer safety.
Slovenian: Za zagotovitev varnosti uporabnikov so bile določene ustrezne karence.