FrancophonIA/ELRC3.0 huggingface dataset:
English: Several residues depletion studies in the different target species were made available, which were variable in terms of reliability of the data, study design and reporting, and subsequently their outcomes.
Slovenian: Na voljo je bilo več študij o izločanju ostankov pri različnih ciljnih vrstah, ki so se med seboj razlikovale glede zanesljivosti podatkov, zasnove študije in poročanja ter posledično glede izidov.
English: Torre Ocidente Rua Galileu Galilei, N.º 2, Piso 7
Slovenian: Farmacêuticos, Lda Torre Ocidente Rua Galileu Galilei, N.º 2, Piso 7
English: These data are consistent with the information available in published literature.
Slovenian: Ti podatki so skladni z informacijami, na voljo v objavljeni literaturi.
English: According to Regulation (EC) No 1177/200610, antimicrobials should not be used as part of national control programs of Salmonella due to public health risks associated with development, selection and spread of resistance.
Slovenian: V skladu z Uredbo (ES) št. 1177/200610 se protimikrobna zdravila v okviru nacionalnih programov nadzora bakterije Salmonella ne smejo uporabljati, in sicer zaradi tveganj za javno zdravje, povezanih s pojavom, selekcijo in širjenjem odpornosti.
English: These studies involved male calves of approximately one week of age naturally infected by E. coli and/or Salmonella spp.
Slovenian: Te študije so vključevale samce telet, stare približno en teden, ki so se naravno okužili z bakterijama E. coli in/ali Salmonella spp.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion on this matter and to harmonise the product information for Girolan and its associated name Apralan (thereafter called Girolan).
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je bil zaprošen, naj poda mnenje o tej zadevi in naj uskladi informacije o zdravilu za zdravilo Girolan in povezano ime Apralan (v nadaljnjem besedilu: zdravilo Girolan).
English: The marketing authorisation holders' grounds for the re-examination were submitted on 18 December
Slovenian: Imetniki dovoljenj za promet z zdravilom so razloge za ponovni pregled predložili 18. decembra 2017.
English: Additional data provided from 2014 indicate that Salmonella Dublin was mostly susceptible to apramycin (96.5% of isolates susceptible to all antimicrobials in the panel, including apramycin).
Slovenian: Dodatni podatki iz leta 2014 kažejo, da je bakterija Salmonella Dublin večinoma občutljiva za apramicin (96,5% izolatov je občutljivih za vsa protimikrobna sredstva v panelu, vključno z apramicinom).
English: Light to medium brown granular powder.
Slovenian: Svetlo do srednje rjav zrnat prašek.
English: Additionally, in some Member States a measuring device was authorised for the administration of Girolan.
Slovenian: Poleg tega je bil v nekaterih državah članicah za dajanje zdravila Girolan odobren merilni pripomoček.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name>
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI <Izmišljeno ime>
English: No recent data about susceptibility of Salmonella Gallinarum or Salmonella Pullorum isolates obtained in clinical cases in Europe were available as salmonellosis caused by these serovars has not been detected in Europe since 2007.
Slovenian: Glede občutljivosti izolatov Salmonella Gallinarum in Salmonella Pullorum, pridobljenih iz kliničnih primerov v Evropi, ni na voljo novejših podatkov, saj salmoneloze, ki jo povzročata ta serovarja, v Evropi že od leta 2007 niso zaznali.
English: Whilst it is not clear if the stability data was generated under controlled conditions or not, given the lack of significant change in active substance content and the fact that the product historically had a shelf life of 3 years, the data is considered adequate to support a 2 year shelf life for the finished product as proposed by the MAH.
Slovenian: Ni jasno, ali so bili podatki o stabilnosti pridobljeni pod nadzorovanimi pogoji, vendar glede na odsotnost bistvenih sprememb vsebnosti zdravilne učinkovine in dejstvo, da je imelo zdravilo v preteklosti rok uporabnosti tri leta, veljajo podatki za zadostne, da podpirajo rok uporabnosti končnega zdravila dve leti, kot predlaga imetnik dovoljenja za promet z zdravilom.
English: Use personal protective equipment consisting of gloves, mask, goggles and protective clothing while handling the product.
Slovenian: Pri ravnanju z zdravilom uporabljajte osebno zaščitno opremo, ki sestoji iz rokavic, maske, zaščitnih očal in zaščitnih oblačil.
English: The presence of E. coli was demonstrated by previous bacteriological or clinical results and was confirmed in samples taken from rabbits sacrificed or found dead after inclusion.
Slovenian: Prisotnost E. coli so dokazali s predhodnimi bakteriološkimi ali kliničnimi dokazi ter potrdili z vzorci, odvzetimi kuncem, ki so bili žrtvovani ali so umrli po vključitvi.
English: With regard to the use of Girolan against Salmonella it was considered that in line with Regulation (EC) No. 1177/200610, antimicrobials should not be used for control and treatment of Salmonella in poultry except in exceptional circumstances.
Slovenian: Kar zadeva učinkovitost zdravila Girolan proti bakteriji Salmonella, je bilo ocenjeno, da se v skladu z Uredbo (EC) št. 1177/200610 protimikrobna zdravila ne smejo uporabljati za nadzor in zdravljenje bakterije Salmonella pri perutnini, razen v izjemnih okoliščinah.
English: Apramycin ……………………………552,000 IU* (as apramycin sulfate) * IU - international units
Slovenian: Apramicin ……………………………552.000 i.e.* (v obliki apramicinijevega sulfata) * i.e. - mednarodne enote
English: Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal.
Slovenian: Uporaba zdravila mora temeljiti na testiranju občutljivosti bakterij, izoliranih iz živali.
English: This is also supported by statistical analysis presented by the MAH which demonstrates that there is no change in assay over time.
Slovenian: To podpira tudi statistična analiza, ki jo je predložil imetnik dovoljenja za promet z zdravilom, ki kaže, da se test sčasoma ne spreminja.
English: In various European monitoring programs, E. coli isolate from chickens were susceptible to apramycin.
Slovenian: V različnih evropskih programih spremljanja so bili izolati E. coli iz piščancev občutljivi za apramicin.
English: The risks associated with use of Girolan are those generally attributed to antimicrobials which are used in food-producing animals, i.e. development of antimicrobial resistance in target bacteria, dissemination of resistant bacteria/resistance factors etc.
Slovenian: Tveganja, povezana z uporabo zdravila Girolan, so enaka kot pri običajnih protimikrobnih zdravilih, ki se uporabljajo pri živalih za proizvodnjo živil, tj. razvoj protimikrobne odpornosti pri ciljnih bakterijskih vrstah, razširjanje odpornih bakterij/dejavnikov odpornosti itd.
English: No data were presented for Salmonella Pullorum.
Slovenian: Podatkov za bakterijo Salmonella Pullorum niso predložili.
English: Since the dosing regimens recommended by the CVMP have not been increased, and the indications have not been extended with regard to those approved in most summaries of product characteristics, the assessment of target animal safety and user safety did not present new issues.
Slovenian: Ker odbor CVMP ni priporočil povečanja sheme odmerjanja in razširitve indikacij glede na večino odobrenih povzetkov glavnih značilnosti zdravila, se pri ocenjevanju varnosti pri ciljnih živalskih vrstah in varnosti uporabnikov niso pojavila nova vprašanja.
English: If irritation persists, seek medical advice.
Slovenian: Če draženje ne preneha, poiščite zdravniško pomoč.
English: In those studies, the animals were examined to confirm the diagnosis prior to the initiation of treatment, bacteriologically and with lesions in different organs; treatment decreased mortality and carcases showed absence of lesions.
Slovenian: V teh študijah so živali pred začetkom zdravljenja pregledali in potrdili diagnozo, bakteriološko in z lezijami v različnih organih; z zdravljenjem se je zmanjšala umrljivost, v truplih pa lezij niso zaznali.
English: In this respect, it was considered necessary to add the following sentence in section 4.5 of the summary of product characteristics (SPC) ‘Special precautions for use in animals': ‘Where a diagnosis of Salmonella Dublin is made on the farm, then control measures including on-going monitoring of disease status, vaccination, biosecurity and movement controls should be considered.
Slovenian: V zvezi s tem so presodili, da je v poglavje 4.5 povzetka glavnih značilnosti zdravila, „Posebni previdnostni ukrepi za uporabo pri živalih“, treba dodati naslednji stavek: „Kadar se na kmetiji diagnosticira Salmonella Dublin, je treba razmisliti o nadzornih ukrepih, vključno s stalnim spremljanjem stanja bolezni, cepljenjem, biološko varnostjo in nadzorom premikanja.
English: Apramycin sulfate 333 mg/ml equivalent to apramycin 230 mg/ml
Slovenian: Apramicinijev sulfat 333 mg/ml, kar ustreza apramicinu 230 mg/ml
English: Some strains of Salmonella Typhimurium DT104 in addition to resistance against betalactams, streptomycin, tetracyclines and sulphonamides carry a conjugative resistance plasmid against apramycin.
Slovenian: Nekateri sevi bakterije Salmonella Typhimurium DT104 poleg odpornosti proti beta-laktamom, streptomicinu, tetraciklinom in sulfonamidom vsebujejo tudi konjugativni plazmid, ki omogoča odpornost proti apramicinu.
English: The dosage, route and frequency of administration are those proposed in the product information.
Slovenian: Odmerek, pot in pogostnost dajanja so navedeni v informacijah o zdravilu.
English: This was not considered acceptable, as the active substance strength should be expressed in IU/g product, since the assay is determined by means of a microbiological method.
Slovenian: To ni bilo ocenjeno kot sprejemljivo, saj je treba jakost zdravilne učinkovine izražati v i.e./g zdravila, ker se test izvaja z mikrobiološko metodo.
English: The referral notification was based on concerns related to divergent national decisions having been taken by EU Member States resulting in discrepancies in the product information with respect to e.g. target species, indications for use, posology (dosage and duration) and withdrawal periods.
Slovenian: Obvestilo o napotitvi je temeljilo na pomislekih, povezanih z različnimi nacionalnimi odločitvami, ki so jih sprejele države članice EU, kar je privedlo do razlik med informacijami o zdravilu glede npr. ciljnih živalskih vrst, indikacij za uporabo, odmerjanja (odmerka in trajanja) in karence.
English: Do not use in animals suffering from kidney disorders.
Slovenian: Ne uporabite pri živalih z ledvičnimi boleznimi.
English: Again, no data for Salmonella Gallinarum was presented and in view of this it was not considered further for this indication.
Slovenian: Podatkov za bakterijo Salmonella Gallinarum niso predložili, zato je pri tej indikaciji niso nadalje presojali.
English: The marketing authorisation holder has provided twelve field trials in support of the efficacy for the indication against E. coli.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v podporo učinkovitosti pri indikaciji proti E. coli predložil 12 terenskih preskušanj.
English: The marketing authorisation holder provided one field trial including chickens artificially infected with Salmonella Pullorum.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil eno terensko preskušanje, ki je vključevalo piščance, umetno okužene z bakterijo Salmonella Pullorum.
English: Moreover, Regulation (EU) No 2016/429 (‘Animal Health Law')12, states that the Member States may take measures concerning the use of veterinary medicinal products for listed diseases to ensure the most efficient prevention or control of those diseases.
Slovenian: Poleg tega Uredba (EU) št. 2016/429 („pravila o zdravju živali“)12 določa, da lahko države članice izvedejo ukrepe glede uporabe zdravil za uporabo v veterinarski medicini za naštete bolezni, da zagotovijo najučinkovitejše preprečevanje ali nadzor teh bolezni.
English: enterica serovar Dublin (Salmonella Dublin) susceptible to apramycin.
Slovenian: enterica, serovar Dublin (Salmonella Dublin), občutljive za apramicin.
English: The CVMP accepted this deletion of Salmonella.
Slovenian: Odbor CVMP je sprejel izbris bakterije Salmonella.
English: 4-ply polyethylene terephthalate (PET)/polyethylene/aluminium foil/surlyn ionomer sachet, sealed by heat and pressure.
Slovenian: Štirislojna vrečka iz polietilen tereftalata (PET)/polietilena/aluminijaste folije/ionomera Surlyn, toplotno zavarjena pod pritiskom.
English: Section 6.4 of the agreed SPC for the product states that no specific storage precautions are required for the product.
Slovenian: Poglavje 6.4 dogovorjenega povzetka glavnih značilnosti zdravila za zdravilo navaja, da za zdravilo niso potrebni posebni pogoji shranjevanja.
English: Surviving calves in the untreated control group failed to gain weight in the twelve days period whereas the survivors in the treated groups showed significant increases in average daily weight gain.
Slovenian: Preživela teleta v nezdravljeni kontrolni skupini v 12-dnevnem obdobju niso pridobila telesne mase, preživela teleta v zdravljenih skupinah pa so na dan povprečno pridobila precej telesne mase.
English: Therefore, the CVMP concluded that the indication for the treatment of Salmonella in poultry could not be justified and should be deleted from the product information for Girolan.
Slovenian: Zato je odbor CVMP zaključil, da indikacija za zdravljenje bakterije Salmonella pri perutnini ni utemeljena in jo je treba izbrisati iz informacij o zdravilu za zdravilo Girolan.
English: • the CVMP reviewed the summary of product characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; the CVMP has recommended the amendment of the marketing authorisations for Girolan and its associated name Apralan as referred in Annex I for which the summary of product characteristics, labelling and package leaflet are set out in Annex III.
Slovenian: • odbor CVMP je pregledal povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenj za promet z zdravilom, in proučil vse predložene podatke, je odbor CVMP priporočil spremembo dovoljenj za promet z zdravilom za zdravilo Girolan in povezano ime Apralan, navedeno v Prilogi I, za katero so v Prilogi III navedeni povzetek glavnih
English: These enzymes confer different cross-resistance against other aminoglycosides.
Slovenian: Ti encimi omogočajo različne vrste navzkrižne odpornosti proti drugim aminoglikozidom.
English: The data provided also indicated that resistance to apramycin is increasing among E. coli isolates of pig origin, so the wording ‘susceptible to apramycin' was added to the indication.
Slovenian: Predloženi podatki so pokazali tudi, da se odpornost proti apramicinu med izolati bakterije E. coli prašičjega izvora povečuje, tako da je bilo k indikaciji dodano besedilo „občutljiva za apramicin“.
English: Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law') - link 13 EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare), 2017.
Slovenian: The EFSA Journal (2004) 115, 1-76 12 Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law') - link 13 EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare), 2017.
English: Apramycin has been shown to be efficacious in the treatment of Salmonella infections in calves where its use reduced mortality and may therefore be justified on animal welfare grounds.
Slovenian: Dokazali so, da je apramicin učinkovit pri zdravljenju okužb z bakterijo Salmonella pri teletih, pri čemer njegova uporaba zmanjšuje umrljivost in je zato lahko utemeljena zaradi dobrega počutja živali.
English: Apramycin resistance can be influenced by co-selection (resistance to apramycin has been described to be located in the same mobile genetic element that other resistant determinants in Enterobacteriaceae) and cross resistance (e. g. with gentamicin).
Slovenian: Na odpornost proti apramicinu lahko vplivata koselekcija (opisali so, da je v družini Enterobacteriaceae odpornost proti apramicinu vsebovana na istem mobilnem genetskem elementu kot druge determinante odpornosti) in navzkrižna odpornost (npr. z gentamicinom).
English: Furthermore, taking into account the data provided and in line with the ‘Note for guidance on start of shelf life of the finished dosage form (EMEA/CVMP/453/01)1', the shelf life period of the veterinary medicinal product as packaged for sale, which was 3 years, was reduced to 18 months.
Slovenian: Z upoštevanjem predloženih podatkov in v skladu s sporočilom glede priporočil za začetek roka uporabnosti končnih farmacevtskih oblik (EMEA/CVMP/453/01)1 je bil rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo, ki je bil prej tri leta, skrajšan na 18 mesecev.
English: The administration of aminoglycosides to animals suffering from renal impairment or in combination with substances that also affect renal function may therefore present a risk of intoxication.
Slovenian: Dajanje aminoglikozidov živalim, ki imajo ledvično okvaro, ali v kombinaciji z učinkovinami, ki tudi vplivajo na delovanje ledvic, zato pomeni tveganje za zastrupitev.
English: EFSA Journal 2017;15(8):4954, 50 pp. https://doi.org/10.2903/j.efsa.2017.4954
Slovenian: EFSA Journal 2017;15(8):4954, 50 pp. https://doi.org/10.2903/j.efsa.2017.4954 14 World Health Organization (2017).
English: Although these risks have not been unequivocally assessed, the possibility of impact on human health through cross-resistance to gantamicin and other substances of the aminoglycoside group is a reality.
Slovenian: Čeprav ta tveganja niso bila nedvoumno ovrednotena, obstaja realna možnost vpliva na zdravje ljudi zaradi navzkrižne odpornosti proti gentamicinu in drugim snovem iz skupine aminoglikozidov.
English: From this study, a withdrawal period of 28 days for calves meat and offal has been established, which is supported by the other references provided.
Slovenian: Iz te študije so izpeljali karenco 28 dni za telečje meso in organe, kar podpirajo tudi druge predložene reference.
English: The intake of medicated water depends on the clinical condition of the animals.
Slovenian: Vnos vode z dodanim zdravilom je odvisen od kliničnega stanja živali.
English: Dose (mg product per kg bodyweight per day)
Slovenian: Odmerek (mg zdravila na kg telesne mase na dan)
English: These studies involved one to three days old calves experimentally challenged with either Salmonella Dublin or Salmonella typhimurium, the most frequent serovars of Salmonella spp.
Slovenian: Te študije so vključevale teleta, stara od enega do tri dni, pri katerih so opravili provokacijski test z bakterijo Salmonella Dublin ali Salmonella typhimurium, tj. najpogostejšima serovarjema Salmonella spp.
English: • Should antimicrobial resistance be already present, develop or be acquired, then the use of antimicrobials for the treatment of clinically infected flocks, for the prevention of Salmonella infection, or for the treatment of infected flocks without clinical signs, will enhance the selection and spread of resistant bacterial strains throughout the production pyramid.
Slovenian: • Če je protimikrobna odpornost že prisotna, se pojavi ali je pridobljena, uporaba protimikrobnih zdravil za zdravljenje klinično okuženih jat, za preprečevanje okužbe z bakterijo Salmonella ali za zdravljenje okuženih jaz brez kliničnih znakov poveča selekcijo in širjenje odpornih bakterijskih sevov po proizvodni piramidi.“
English: Moreover, Regulation (EU) No 2016/429 (‘Animal Health Law')12, that lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans, in Article 46 it is stated that the Member States may take measures concerning the use of veterinary medicinal products for listed diseases to ensure the most efficient prevention or control of those diseases, provided that such measures are appropriate or necessary.
Slovenian: Poleg tega Uredba (EU) št. 2016/429 („pravila o zdravju živali“)12, ki določa pravila za preprečevanje in nadzor živalskih bolezni, ki se prenašajo z živali na ljudi, v členu 46 določa, da lahko države članice izvedejo ukrepe glede uporabe zdravil za uporabo v veterinarski medicini za naštete bolezni, da zagotovijo najučinkovitejše preprečevanje ali nadzor teh bolezni, pod pogojem, da so ti ukrepi primerni ali potrebni.
English: This product may cause irritation or sensitisation after skin or eye contact or inhalation.
Slovenian: To zdravilo lahko po stiku s kožo ali očmi ali po vdihavanju povzroča draženje ali preobčutljivost.
English: Pigs have been authorised as a target species for all products concerned by this referral procedure, as was the proposed indication, ‘Treatment of bacterial enteritis caused by Escherichia coli susceptible to apramycin.'
Slovenian: Prašiči so bili odobreni kot ciljna živalska vrsta za vsa zdravila, ki jih zadeva ta napotitveni postopek, enako kot predlagana indikacija „zdravljenje bakterijskega enteritisa, ki ga povzroča Escherichia coli, občutljiva za apramicin“.
English: Shelf life after dilution in drinking water/milk replacer according to directions: 24 hours.
Slovenian: Rok uporabnosti po razredčenju z vodo za pitje/mlečnim nadomestkom v skladu z navodili: 24 ur.
English: 100% w/w
Slovenian: 100% m/m
English: Some studies pointed out resistance percentages of 38% (MIC data) or even higher for disk diffusion (up to
Slovenian: V nekaterih študijah so določili delež odpornosti 38% (podatki o MIK), pri metodi difuzije z diski pa je bil delež celo višji (do 82,1%).
English: Aminoglycosides are listed by WHO (2017)14 as critically important for the treatment of certain zoonotic infections in humans (such as Enterococcus infections).
Slovenian: Svetovna zdravstvena organizacija (2017)14 navaja, da so aminoglikozidi ključnega pomena za zdravljenje določenih zoonotskih okužb pri ljudeh (kot so okužbe z bakterijami Enterococcus).
English: Do not use in case of hypersensitivity to apramycin.
Slovenian: Ne uporabite v primerih preobčutljivosti na apramicin.
English: Even host-adapted serovars (as Salmonella Dublin) might cause disease in humans (Evangelopoulou et al., 20142; Singh, 20133) so the use of antimicrobials in food producing animals should consider the zoonotic role of Salmonella and the consequences for public health (EFSA and ECDC, 20164).
Slovenian: Tudi serovarji, prilagojeni na gostitelja (kot je Salmonella Dublin), bi lahko pri človeku povzročili bolezen (Evangelopoulou in drugi, 20142; Singh, 20133), zato je treba pri uporabi protimikrobnih zdravil pri živalih za proizvodnjo živil upoštevati tudi zoonotsko vlogo bakterije Salmonella in posledice za javno zdravje (EFSA in ECDC, 20164).
English: The objectives were to evaluate the efficacy of apramycin sulfate, administered in the drinking water for five consecutive days, at dose levels of 75, 150 and 225 mg/litre as treatment for these infections.
Slovenian: Cilj je bil ovrednotiti učinkovitost apramicinijevega sulfata, ki so ga dajali v vodo za pitje pet dni zapored v odmerkih 75, 150 in 225 mg/liter, kot zdravila za te okužbe.
English: In case of eye contact, rinse the affected area with plenty of water.
Slovenian: V primeru stika z očmi prizadeti predel sperite z obilo vode.
English: Therefore, the CVMP considered it justified to retain the indication for Salmonella Dublin for Girolan.
Slovenian: Zato je odbor CVMP menil, da je upravičeno, da se za zdravilo Girolan ohrani indikacija za bakterijo Salmonella Dublin.
English: Chickens: Do not use in laying hens and within 4 weeks before the onset of the laying period.
Slovenian: Piščanci: Ne uporabite pri kokoših nesnicah in v obdobju štirih tednov pred začetkom obdobja nesnosti.