FrancophonIA/ELRC3.0 huggingface dataset:
English: However, several experimental controlled studies were conducted employing both 2.5 and 5 mg/kg body weight (bw) parenteral doses, but more consistent data on the higher dose were presented.
Slovenian: Opravili so več eksperimentalnih nadzorovanih študij z obema parenteralnima odmerkoma 2,5 in 5 mg/kg telesne mase, vendar so bili predloženi doslednejši podatki za večji odmerek.
English: As enrofloxacin is known to cause CNS stimulation, the contraindications in epileptic animals or in animals that suffer from seizures are justified.
Slovenian: Ker je znano, da enrofloksacin stimulira osrednje živčevje, so kontraindikacije pri epileptičnih živalih ali živalih z epileptičnimi napadi upravičene.
English: Both strengths share the same indications, but differences exist in terms of target animal species i.e. in the 50 mg/ml strength the species were stated as dairy ewes/lambs and dairy goats/kids whereas in the 100 mg/ml strength the species were sheep and goats.
Slovenian: Obe jakosti imata enake indikacije, vendar obstaja razlika pri ciljnih živalskih vrstah, tj. pri jakosti 50 mg/ml so kot ciljne živalske vrste navedene ovce molznice/jagnjeta in koze molznice/kozlički, pri jakosti 100 mg/ml pa ovce in koze.
English: aureus) was 39.5% in the 2.5 mg/kg group and 82% in the 5 mg/kg group.
Slovenian: aureus) v skupini 2,5 mg/kg telesne mase je bil 39,5 %, v skupini s 5 mg/kg telesne mase pa 82 %.
English: Further to the concerns expressed by the CVMP regarding the aforementioned two indications CVMP recommended the removal of these from the product information.
Slovenian: Poleg pomislekov, ki jih je odbor CVMP izrazil glede zgornjih indikacij, je priporočil tudi njun izbris iz informacij o zdravilu.
English: As stated in CVMP reflection paper on the use of fluoroquinolones in food producing animalsPrecautions for use in the SPC regarding prudent use guidance6, 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: Kot je navedeno v dokumentu s presojo CVMP o uporabi fluorokinolonov pri živalih za proizvodnjo mesa - Previdnostni ukrepi za uporabo v povzetku glavnih značilnosti zdravila, povezani s smernico o preudarni uporabi6, je treba uporabo fluorokinolonov omejiti na zdravljenje kliničnih stanj, ki se slabo odzivajo ali za katere je pričakovati, da se bodo slabo odzivala na druge razrede antibiotikov.
English: A dose-confirmation study and a field study showed clinical efficacy of the dose of 5 mg/kg bw/day against enzootic pneumonia caused by M. haemolytica and
Slovenian: Študija za potrditev odmerka in terenska študija sta pokazali klinično učinkovitost odmerka 5 mg/kg telesne mase/dan proti enzootični pljučnici, ki jo povzročata M. haemolytica in
English: 30 mg. For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Do not use in birds intended for human consumption.
Slovenian: Ni dovoljena uporaba pri pticah ki so namenjene prehrani ljudi
English: Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation.
Slovenian: Ne uporabite pri živalih z epileptičnimi napadi, saj enrofloksacin povzroča stimulacijo CŽS.
English: (e.g. Staphylococcus aureus) and against Mycoplasma spp.
Slovenian: (npr. Staphylococcus aureus) in proti Mycoplasma spp.
English: Shelf life of the veterinary product as packaged for sale: 4 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 4 leta
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 IV, ki vodi do sprememb posameznega encima, (ii) sprememb prepustnosti za zdravilo pri Gram-negativnih bakterijah, (iii) mehanizma efluksa, (iv)
English: Warning sentences are sufficient to ensure the safe use of the product by the person who administers the product.
Slovenian: Opozorilni stavki so zadostni za zagotavljanje varne uporabe zdravila v zvezi z osebami, ki živalim dajejo zdravilo.
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 kompleksi kompleksa 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 use of enrofloxacin in growing lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, not associated to clinical signs.
Slovenian: Uporaba enrofloksacina pri rastočih jagnjetih, v priporočenem odmerku, v obdobju 15 dni, je povzročila histološke spremembe sklepnega hrustanca, ki niso bile povezane s kliničnimi znaki.
English: In pigs, the injection should be made in the neck at the ear base.
Slovenian: Pri prašičih je mesto aplikacije je v vrat na bazi ušesa.
English: To ensure a correct dosage, body weight (bw) should be determined as accurately as possible to avoid underdosing.
Slovenian: Da bi zagotovili natančno odmerjanje, je potrebno določiti telesno težo kar se da natančno.
English: Milk: 4 days.
Slovenian: 4 dni mleko
English: The safety of the veterinary medicinal product has been established in pregnant cows during the 1st quarter of pregnancy.
Slovenian: Varnost zdravila je bila ugotovljena pri brejih kravah v prvi četrtini brejosti.
English: Bioavailability is high (approximately 100% in pigs) with a low to moderate plasma protein binding (approximately from 20 to 50%).
Slovenian: 100% pri prašičih) z nizko do zmerno vezavo na plazemske proteine (približno 20 do 50%).
English: The data provided are insufficient to justify two indications in cattle (i) ‘treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Histophilus somni' and (ii) ‘treatment of acute severe mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus'.
Slovenian: Razpoložljivi podatki za upravičenost dveh indikacij pri govedu i) „zdravljenje okužb dihal, ki jih povzročajo za enrofloksacin občutljivi sevi Histophilus somni,“ in ii) „zdravljenje akutnega hudega mastitisa, ki ga povzročajo za enrofloksacin občutljivi sevi Staphylococcus aureus,“ so nezadostni.
English: Target inhibition is caused by noncovalent binding of fluoroquinolone molecules to these enzymes.
Slovenian: Ciljna inhibicija nastane zaradi nekonvalentne vezave molekul fluorokinolonov na ta encima.
English: The use of the product in cows during the 3 last quarters of pregnancy should be based on a benefit/risk assessment by the responsible veterinarian.
Slovenian: Uporaba zdravila v zadnjih treh četrtinah brejosti naj temelji na oceni razmerja korist/tveganje odgovornega veterinarja.
English: This section takes into account a possible hypersensitivity to fluoroquinolones or to any excipients of the product.
Slovenian: To poglavje obravnava morebitno preobčutljivost za fluorokinolone ali katero koli drugo sestavino zdravila.
English: Use of the product including use deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to enrofloxacin and may decrease the effectiveness of treatment with all fluoroquinolones due to the potential for cross-resistance.
Slovenian: Uporaba zdravila vključno z uporabo, ki ni v skladu z navodili, navedenimi v povzetku glavnih značilnosti zdravila, lahko poveča razširjenost bakterij, odpornih na enrofloksacin in lahko zmanjša učinkovitost zdravljenja z drugimi fluorokinoloni zaradi možnosti navzkrižne odpornosti.
English: Bioavailability is high (approximately 100% in pig and cattle) with a low to moderate plasma protein binding (approximately 20 to 50%).
Slovenian: 100% pri prašičih in govedu) z nizko do zmerno vezavo na plazemske proteine (približno 20 do 50%).
English: Treatment may be initiated with injectable product and maintained with enrofloxacin tablets.
Slovenian: Zdravljenje lako začnemo z injekcijsko obliko in nadaljujemo z enrofloksacin tabletami.
English: In rabbits, reactions (from reddening to ulcerative lesions with deep loss of tissue), may occur.
Slovenian: Pri kuncih se lahko pojavijo reakcije (od rdečine do razjed kože z izgubo globinskega tkiva).
English: Enrofloxacin is reported to have deleterious effect on articular cartilage in growing horses.
Slovenian: Poročali so, da ima enrofloksacin škodljiv učinek na sklepni hrustanec pri odraščajočih konjih.
English: Depending on species, the safety of the veterinary medicinal product has been established through specific studies in pregnant and/or lactating animals (cows, sows).
Slovenian: Varnost zdravila za uporabo v veterinarski medicini so potrdili s specifičnimi študijami na nekaterih živalih v obdobju brejosti in/ali laktacije (kravah, svinjah).
English: Not more than 3 ml should be administered at one intramuscular injection site.
Slovenian: Apliciramo lahko ne več kot 3 ml na eno mesto vboda intramuskularno.
English: • the CVMP considered the scope of the referral was the harmonisation of the summaries of product characteristics, labelling and package leaflets;
Slovenian: • CVMP je menil, da je bil namen napotitve uskladitev povzetkov glavnih značilnosti zdravila,
English: Special caution should be taken when using enrofloxacin in cats because higher doses than recommended can cause retinal damage and blindness (see section 4.10).
Slovenian: Posebna previdnost je potrebna pri uporabi enrofloksacina pri mačkah, saj odmerki, višji od priporočenih, lahko povzročijo poškodbe mrežnice in slepoto (glej poglavje 4.10).
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Slovenian: Zaradi odsotnosti študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
English: Overall summary of the scientific evaluation of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil Baytril 2,5 % raztopina za injiciranje, Baytril 5 % raztopina za injiciranje ter Baytril 10 % raztopina za injiciranje in povezanih imen (glejte Prilogo I)
English: In reptiles and birds, muscle bruising may occur in very rare cases.
Slovenian: V zelo redkih primerih se pri plazilcih in pticah lahko pojavijo modrice mišic.
English: aureus following use of the product in food rabbits was considered:
Slovenian: aureus po uporabi zdravila pri kuncih za prehrano ljudi:
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: Flourokinolone uporabite le za zdravljenje kliničnih stanj, pri katerih je bil opažen ali se pričakuje slab odziv na zdravljenje z drugimi vrstami protimikrobnih zdravil.
English: Subcutaneous or intramuscular use.
Slovenian: Uporablja se subkutano ali intramuskularno.
English: The product can be used in cows during lactation.
Slovenian: Lahko se uporablja pri kravah v obdobju laktacije.
English: African Grey Parrots serum ciprofloxacin concentrations were 3-78% of the enrofloxacin dose, with an increasing ciprofloxacin/enrofloxacin ratio with multiple doses.
Slovenian: Koncentracije ciprofloksacina v serumu afriške sive papige so bile 3-78% od odmerka enrofloksacina,
English: <Date of first authorisation:> <{DD/MM/YYYY}><{DD month YYYY}.>
Slovenian: <{DD/MM/LLLL}> <{DD mesec LLLL}>…
English: The discard date should be recorded on the label of the glass vial after the vial was broached for the first time.
Slovenian: Datum uničenja zdravila po prvem odprtju viale mora biti označen na stekleni viali.
English: Intravenous, subcutaneous or intramuscular use.
Slovenian: Uporablja se intravenozno, subkutano ali intramuskularno.
English: Duration of treatment should be based on the duration of treatment approved for the appropriate indication in the product information of the tablet product.
Slovenian: Trajanje zdravljenja poteka v skladu z odobrenimi navodili za uporabo tablet.
English: France referred the issue due to divergent national decisions having been taken by the Member States (EU/EEA) resulting in discrepancies in the product information for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names.
Slovenian: Francija je sprožila napotitev zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice EU/EGP, kar je povzročilo odstopanja v informacijah o zdravilu za zdravila Baytril 2,5 % raztopina za injiciranje, Baytril 5 % raztopina za injiciranje ter Baytril 10 % raztopina za injiciranje in povezana imena.
English: In pigs, after intramuscular administration of the product, inflammatory reactions may occur.
Slovenian: Pri prašičih se lahko po intramuskularnem dajanju na mestu vboda pojavijo vnetne reakcije.
English: 6 CVMP reflection paper on the use of fluoroquinolones in food producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf
Slovenian: CVMP reflection paper on the use of fluoroquinolones in food producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf 7 CVMP public statement on the use of (fluoro)quinolones in food-producing animals in the European Union:
English: They may persist at least up to 17 days after the injection.
Slovenian: Te lahko vztrajajo do 17 dni po dajanju.
English: To be completed nationally.
Slovenian: Izpolni država članica
English: Not all pack sizes may be marketed.
Slovenian: Ni nujno da so v prometu vsa navedena pakiranja.
English: In dogs, rabbits, small rodents, reptiles and birds, overdose has not been documented.
Slovenian: Pri psih, kuncih, malih glodavcih, plazilcih in pticah niso poročali o prekomernem odmerjanju.
English: The specific properties of enrofloxacin regarding both its use in animals with renal disorders and retinal toxicity in cats are also stated.
Slovenian: Navedene so tudi posebne značilnosti enrofloksacina, povezane z uporabo pri živalih z motnjami delovanja ledvic in toksičnostjo za očesno mrežnico pri mačkah.
English: Special caution should be taken when using enrofloxacin in cats because higher doses than recommended can cause retinal damage and blindness.
Slovenian: Posebna previdnost je potrebna pri uporabi enrofloksacina pri mačkah, saj odmerki, višji od priporočenih, lahko povzročijo poškodbe mrežnice in slepoto.
English: Repeated injections should be made at different injection sites.
Slovenian: Za ponavljanje injiciranja, uporabimo vedno drugo mesto vboda.
English: Cmax (µg/ml) AUC (µg∙h/ml) Terminal half-life (h) Elimination half-life (h) F (%)
Slovenian: AUC (µg∙h/ml) Končni razpolovni čas (h) Razpolovna doba izločanja
English: Special precautions for use in animals: Official and local antimicrobial policies should be taken into account when the product is used.
Slovenian: POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih Upoštevajte uradno in lokalno doktrino uporabe protimikrobnih zdravil.
English: Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg body weight during 14 days.
Slovenian: Degenerativne spremembe sklepnega hrustanca so opazili pri teletih, po peroralnem dajanju 30 mg enrofloksacina/kg telesne teže v obdobju 14 dni.
English: They may persist up to 28 days after the injection.
Slovenian: Te lahko vztrajajo do 28 dni po aplikaciji.
English: For cats weighting less than 5 kg, the dosage of 25 mg/ml is more appropriate to avoid risk of overdosage (see section 4.10).
Slovenian: 25mg/ml, da se izognemo prekomernemu odmerjanju (glej poglavje 4.10).
English: Enrofloxacin is rapidly absorbed after parenteral injection.
Slovenian: Enrofloksacin se po paranteralni aplikaciji hitro absorbira.
English: Rodents, reptiles and ornamental birds (25 mg/ml strength)
Slovenian: Glodavci, plazilci in okrasne ptice (jakost 25 mg/ml)
English: Milk: 3 days.
Slovenian: 6 dni mleko:
English: (e.g. Pasteurella multocida), Bordetella spp., Proteus spp., Pseudomonas spp., against Gram-positive bacteria such as Staphylococcus spp.
Slovenian: (npr. Pasteurella multocida), Bordetella spp., Proteus spp., Pseudomonas spp., proti Gram-pozitivnim bakterijam kot so Staphylococcus spp.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: Najpogostejši neželeni učinek je v skupini naveden prvi, po naslednjem dogovoru: - Zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali) - Pogosti (pojavijo se pri 1 od 10 živali od 100 živali)
English: 4.2 Indications for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Psi
English: The product can be used in pregnant cows during the 1st quarter of pregnancy.
Slovenian: Zdravilo se lahko uporablja pri brejih kravah v prvi četrtini brejosti.
English: They may persist up to 28 days after the injection
Slovenian: Te lahko vztrajajo do 28 dni po dajanju.
English: However, taking into account the available PK/PD and resistance data it has been concluded that the dose for this indication can be accepted only at 5 mg of enrofloxacin per kg bw once daily for 3 days by intramuscular injection.
Slovenian: Vendar je odbor na podlagi razpoložljivih FK/FD podatkov in podatkov o odpornosti sklenil, da je za to indikacijo mogoče sprejeti samo odmerek enrofloksacina 5 mg na kg telesne mase enkrat na dan 3 dni, ki se daje z intramuskularnim injiciranjem.
English: In cases of accidental overdoses digestive tract disorders (e.g. vomiting, diarrhoea) and neurological disorders may occur.
Slovenian: V primeru nenamernega prevelikega odmerjanja se lahko pojavijo prebavne motnje (npr. bruhanje, driska) in nevrološke motnje.
English: Do not use in animals with known hypersensitivity to enrofloxacin or other fluoroquinolones or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti na enrofloksacin ali drug fluorokinolon ali katerokoli pomožno snov.
English: Enrofloxacin is metabolized to the active substance ciprofloxacin at approximately 40% in dogs and less than 10% in cats and pigs.
Slovenian: Enrofloksacin se presnovi v aktivni ciprofloksacin v približno 40% pri psihin v manj kot 10% pri mačkah in prašičih.
English: Birds and reptiles
Slovenian: Ptice in plazilci
English: Use in pregnancy and lactation
Slovenian: Uporaba v obdobju brejosti in laktacije
English: Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany
Slovenian: Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Nemčija
English: Summaries of product characteristics, labelling and package leaflets
Slovenian: Povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo
English: The second dose may be administered by the subcutaneous route.
Slovenian: Drug odmerek se lahko aplicira subkutano.
English: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Slovenian: Zdravilo uporabite samo na podlagi ocene razmerja korist/tveganje odgovornega veterinarja.
English: Pack-sizes:
Slovenian: Velikosti pakiranja:
English: 3 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Hipralona_Enro
Slovenian: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Hipralona_EnroS/vet_referral_000067.jsp&mid=WC0b01ac05805c5170
English: 7 CVMP public statement on the use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
Slovenian: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
English: Based on the available data in sheep and with the addition of an uncertainty factor of 1.5 a goat meat and offal withdrawal period of 6 days is supported following a subcutaneous injection at the recommended dose of 5 mg/kg bw.
Slovenian: Na podlagi razpoložljivih podatkov za ovce in ob upoštevanju faktorja negotovosti 1,5 je bila določena 6-dnevna karenca za kozje meso in organe po subkutanem injiciranju pri priporočenem odmerku 5 mg/kg telesne mase.
English: Several proprietary studies and numerous scientific publications, documenting the efficacy of enrofloxacin, either by injectable and/or oral route of administration, were provided to demonstrate the efficacy against the above specified bacteria for the intended indications in both dogs and cats
Slovenian: Za dokazovanje učinkovitosti proti zgoraj navedenim bakterijam pri predvidenih indikacijah za pse in mačke se je predložilo več lastniških študij in veliko znanstvenih publikacij, ki so dokumentirale učinkovitost injiciranega in/ali peroralnega enrofloksacina.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the vial after {abbreviation used for expiry date}.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini .
English: Special caution should be taken when using enrofloxacin in animals with impaired renal function.
Slovenian: Posebna previdnost je potrebna pri živalih z oslabljeno ledvično funkcijo.
English: Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana))
Slovenian: Psi, mačke in ostale eksotične vrste (glodavci, kunci, ptice v kletkah in plazilci (kače, želve in iguane)
English: - In a study 4.2% of 71 isolates of Staph.
Slovenian: - V nemški študiji, v kateri so med letoma 2006 in 2007 zbrali 71 izolatov Staph.
English: In cattle, sheep and goat, overdose has not been documented.
Slovenian: Pri govedu, ovcah in kozah ni bila dokumentirana aplikacija prevelikega odmerka.
English: The use should be done only accordingly to the benefit-risk assessment by the responsible veterinarian.
Slovenian: Uporabljati se sme samo v skladu z oceno razmerja med tveganji in koristmi, ki jo opravi odgovorni veterinar.
English: Bayer Portugal S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Slovenian: Portugalska Bayer Portugal S.A. Rua Quinta do Pinheiro, 5
English: Cats have been shown to suffer ocular damage after receiving doses of more than 15 mg/kg once daily for 21 consecutive days.
Slovenian: Pri mačkah so se pojavile poškodbe oči, pri odmerkih večjih od 15 mg/kg enkrat dnevno, 21 zaporednih dni.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the vial after {abbreviation used for expiry date}
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.