FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Antibacterials for systemic use, gentamicin.
Croatian: Farmakoterapijska grupa: Antibakterik za sistemsku primjenu, gentamicin.
English: However, no target animal safety studies using a substantiated scientific study design, as recommended in the VICH guideline 431 on target animal safety have been conducted covering the authorised dosing regimens and routes of administration in adult horses and foals, in particular in regard to gentamicin-induced nephrotoxicity.
Croatian: No, nisu provedena ispitivanja sigurne uporabe u ciljnih životinja primjenom dizajna znanstvenog ispitivanja potkrijepljenog dokumentima, kako je preporučeno u VICH smjernici 431 o sigurnoj primjeni u ciljnih životinja, a koja bi obuhvatila odobrene režime doziranja i načine primjene u odraslih konja i ždrjebadi, posebice u vezi s nefrotosičnošću induciranom gentamicinom.
English: There are three types of aminoglycoside modifying enzymes:
Croatian: Postoje tri tipa enzima koji modificiraju aminoglikozide:
English: Use only based on the benefit-risk assessment by the responsible veterinarian.
Croatian: Uporaba se mora temeljiti na ocjeni omjera koristi i rizika od strane odgovornog veterinara.
English: Therapeutic blood monitoring of gentamicin concentration is also recommended because of known individual animal variations in peak and trough gentamicin plasma concentrations.
Croatian: Također se preporuča terapijsko praćenje koncentracije gentamicina u krvi zbog poznatih individualnih varijacija u vršnim i najnižim koncentracijama gentamicina u plazmi.
English: The safety in pregnant horses is unknown.
Croatian: Nije utvrđena sigurnost u gravidnih kobila.
English: The genes encoding for aminoglycoside modifying enzymes are usually found on plasmids and transposons.
Croatian: Kodiranje gena za enzime koji modificiraju aminoglikozide najčešće je prisutno u plazmidima i transpozonima.
English: IAPSA PORTUGUESA PECUÁRIA, LDA Avenida do Brasil nº 88 7º Esq 1700-073 Lisboa Portugal
Croatian: PECUÁRIA, LDA Avenida do Brasil nº 88 7º Esq
English: Currently injectable veterinary medicinal products containing gentamicin for use in horses are authorised in the EU for the treatment of a variety of indications, including broad ones such as infections of the respiratory tract, gastrointestinal, and genito-urinary tract, caused by various target pathogens.
Croatian: Trenutni injektibilni veterinarsko-medicinski proizvodi koji sadrže gentamicin za primjenu u konja odobreni su u EU za liječenje niza indikacija, uključujući indikacije širokog spektra poput infekcija respiratornog trakta, gastrointestinalnog trakta i genitourinarnog trakta uzrokovanih različitim ciljnim patogenima.
English: Pharmacokinetics of gentamicin change considerably in the first 2 weeks of a foal's life - plasma concentrations of gentamicin are more difficult to achieve in neonatal foals and gentamicin is retained longer in the body, especially kidneys, compared to adults leading to a higher likelihood of gentamicin-induced nephrotoxicity.
Croatian: Farmakokinetika gentamicina mijenja se značajno u prva dva tjedna života ždrjebeta - koncentracije gentamicina u plazmi teže se postižu u neonatalne ždrjebadi, a gentamicin se dulje zadržava u tijeku, posebice u bubrezima, u usporedbi s odraslim konjima što rezultira povećanim izgledima za nefotoksičnost induciranu gentamicinom.
English: 4.11 Withdrawal period(s) Not authorised for use in horses producing meat or milk for human consumption.
Croatian: 4.11. Karencija(e) Nije odobrena primjena na konjima koji se koriste u proizvodnji mesa ili mlijeka za ljudsku upotrebu.
English: 4.9 Amounts to be administered and administration route Horses:
Croatian: Količine koje se primjenjuju i put primjene Konji:
English: This is primarily due to its fast bacteriocidal effect against Gram-negative bacteria, its chemical stability and synergy with beta-lactam antibiotics.
Croatian: Razlog tomu je prvenstveno njegovo brzo bakteriološko djelovanje protiv gram-negativnih bakterija, njegova kemijska stabilnost i sinergija s beta-laktam antibioticima.
English: 4.7 Use during pregnancy, lactation or lay The safety in pregnant horses is unknown.
Croatian: Primjena tijekom graviditeta, laktacije ili nesenja Nije utvrđena sigurnost u gravidnih kobila.
English: Spain LABORATORIOS CALIER, S.A. C/ Barcelonés, 26
Croatian: Španjolska LABORATORIOS CALIER, S.A. C/ Barcelonés, 26
English: The relatively low approved dose and the target pathogens indicated for Gentaject 10% solution for injection gave grounds for Denmark to be concerned as to whether the proposed indications and dosage regimen for this product are supported by adequate data, given evidence from recent scientific publications.
Croatian: Relativno mala odobrena doza i ciljni patogeni indicirani za Gentaject 10% otopinu za injekciju poslužili su kao osnova Danskoj za zabrinutost vezanu uz predložene indikacije i režime doziranja, te jesu li isti pokrijepljeni primjerenim podacima, uzimajući u obzir dokaze iz najnovijih znanstvenih publikacija.
English: It was questioned whether the product is effective for these indications and if the low approved doses may in turn increase resistance rates among equine bacteria towards gentamicin.
Croatian: Postavljeno je pitanje je li proizvod djelotvoran u ovim indikacijama, te mogu li male odobrene doze povećati stope rezistencije među konjskim bakterijama na gentamicin.
English: Based on all available evidence, the CVMP considered that a single daily dose of 6.6 mg gentamicin/kg bw, administered intravenously, would provide an efficacious dose, taking into account the desired PK/PD characteristics for a concentration-dependent antibiotic, i.e. optimal maximum serum concentration (Cmax) to MIC ratio of 8-10, and assuming a bacterial MIC ≤2 µg/ml.
Croatian: Na temelju dostupnih dokaza, CVMP je zaključio da bi jedna dnevna doza od 6,6 mg gentamicina/kg po tt, primijenjena intravenozno, osigurala učinkovitu dozu, uzimajući u obzir željene FK/FD značajke za antibiotika ovisnih o koncentraciji, odnosno omjer optimalne maksimalne koncentracije seruma (Cmax) u odnosu na MIC od 8-10, te pretpostavljajući bakterijski MIC od ≤2 µg/ml.
English: Particular caution should be taken when administering gentamicin with other potential nephrotoxic medicinal products (containing e.g. NSAIDs, furosemide, and other aminoglycosides).
Croatian: Posebnu pozornost treba primijeniti u slučaju primjene gentamicina s drugim potencijalnim lijekovima koji su nefrotoksični (koji sadrže primjerice NSAID-ove, furosemid kao i druge aminoglikozide).
English: WITHDRAWAL PERIOD Not authorised for use in horses producing meat or milk for human consumption.
Croatian: Nije odobrena primjena na konjima koji se koriste u proizvodnji mesa ili mlijeka za ljudsku upotrebu.
English: Gentamicin is best considered as a narrow-spectrum Gram-negative bactericidal antimicrobial (e.g. E. coli, Proteus, Pseudomonas).
Croatian: Najbolje je promatrati gentamicin kao gram-negativan baktericidni antimikrobidal uskog spektra (primjerice E. coli, Proteus, Pseudomonas).
English: The Committee therefore concluded that a single dose of 6.6 mg gentamicin/kg bw given intravenously once daily for 3-5 consecutive days would provide an efficacious dose for adult horses, when used according to the SPC.
Croatian: Stoga je Odbor zaključio da bi jedna doza od 6,6 mg gentamicin/kg po tt koja se primjenjuje intravenozno jednom dnevno tijekom 3-5 uzastopnih dana osigurala djelotvornu dozu za odrasle koje, ako se primjenjuje u skladu sa SPC-om.
English: Their rate of killing increases as the gentamicin concentration increases above the minimum concentration (MIC) for a given Gram-negative pathogen, with optimal maximum serum concentration (Cmax) to MIC ratio of 8
Croatian: StoPa ubijanja bakterija povećava se povećavanjem koncentracije gentamicina iznad minimalne koncentracije (MIC) za dani gram-negativan patogen, s omjerom optimalne maksimalne koncentracije seruma (Cmax) u odnosu na MIC od 8-10.
English: Only very limited data are available to support the range of indications and dose regimens and the CVMP was asked to review the data available and to recommend scientifcally justified indications and a safe and efficacious dosing regimen in horses.
Croatian: Budući da su dostupni samo vrlo ograničeni podaci koji podržavaju raspon indikacija i režima doziranja, od CVMP-a zatraženo je da pregleda dostupne podatke te da preporuči znanstveno opravdane indikacije i učinkovite režime doziranja u konja.
English: The Committee considered that for any other indications for horses for injectable products contaning gentamicin, applicants/marketing authorisation holders (MAHs) would need to submit appropriate data, following up-to-date requirements.
Croatian: Odbor je zaključio kako za bilo koju drugu indikaciju za konje za injektabilne VMP-ove koji sadrže gentamicin, podnositelji zahtjeva/nositelj odobrenja za stavljanje lijeka u promet (MAH) treba dostaviti odgovarajuće podatke u skladu s ažuriranim zahtjevima.
English: Pregnancy:
Croatian: Gravidnost:
English: Lithuania Dopharma Research B.V. Zalmweg 24m 4941 VX Raamsdonksveer the Netherlands
Croatian: Zalmweg 24m 4941 VX Raamsdonksveer Nizozemska
English: Nephrotoxicity is the main risk to the target animal from gentamicin that could occur within therapeutic doses.
Croatian: Nefrotoksičnost je glavni rizik u ciljnih životinja uslijed primjene gentamicina, a može nastupiti u okviru terapijskih doza.
English: The use of gentamicin in foals and neonates is not recommended.
Croatian: Primjena gentamicina u ždrjebadi i neonatalnih životinja nije preporučena.
English: Horse
Croatian: Konj
English: Gentamicin is de-activated in the presence of inflammatory debris, low oxygen environments and low pH.
Croatian: Gentamicin se deaktivira u prisutnosti upalnog debrija, okruženja male koncentracije kisika i niskog pH.
English: An application for the product Genta Equine 10% solution for injection for horses, containing gentamicin as the active substance was submitted to Denmark as a concerned Member State in a mutual recognition procedure (MRP) under the legal basis of Article 13(1) of Directive 2001/82/EC, i.e. a generic application.
Croatian: Danska kao država članica u postupku podnijela je zahtjev za VMP Genta Equine 10% otopina za injekciju za konje, koji sadrži gentamicin kao djelatnu tvar, postupku međusobnog priznavanja (MRPu) po pravnoj osnovi članka 13. stavka 1. Direktive 2001/82/EZ, odnosno za generičku primjenu.
English: Croatia Krka - Farma d.o.o.
Croatian: Hrvatska Krka - Farma d.o.o. Radnička cesta 48
English: Nephrotoxicity is especially a concern in foals.
Croatian: Nefrotoksičnost je razlog za posebnu zabrinutost u ždrjebadi.
English: Latvia Huvepharma AD 33 James Boucher Blvd. Sofia 1407
Croatian: Huvepharma AD 33 James Boucher Blvd.
English: • on the basis of the available data, the CVMP considered that the dosage regimen should be amended as described in Annex III;
Croatian: • na osnovu dostupnih podataka, CVMP zaključio da se režim doziranja treba dopuniti kako je opisano u Prilogu III.;
English: Vijenac A. Cesarca 16
Croatian: Cesarca 16
English: Gentamicin does not have effects on anaerobe bacteria and mycoplasmas.
Croatian: Gentamicin ne djeluje na anaerobne bakterije i mikoplazme.
English: Close monitoring of horses being treated with gentamicin is strongly advised.
Croatian: Izričito se preporuča pažljivo praćenje konja koji se liječe gentamicin.
English: The CVMP notes that pursuant to Article 36 of the Directive, its obligation is to consider the matter concerned and issue a reasoned opinion within the appropriate time limit.
Croatian: Direktive, njegova obveza razmotriti predmetno pitanje te izdati pojašnjeno mišljenje unutar primjerenog vremenskog razdoblja.
English: Spain Laboratorios e Industrias IVEN, S.A
Croatian: Španjolska Laboratorios e Industrias IVEN, S.A
English: Another mechanism predominates at low concentrations in which amino acid codons are misread by tRNA and proof-reading is impaired.
Croatian: Drugi mehanizam predominira u malim koncentracijama u kojima tRNA pogrešno iščitava kodone amnino kiseline, te nastupa pogrešno čitanje dokaza.
English: Annex III
Croatian: Prilogu III.;
English: This is primarily due to its fast bacteriocidal effect against Gram-negative bacteria for which there are only limited treatment choices available, its chemical stability and synergy with betalactam antibiotics.
Croatian: Ovo je prvenstveno uzrokovano brzim baktericidnim djelovanjem protiv gram-negativnih bakterija za koje su dostupne samo ograničene mogućnosti terapije, kemijskom stabilnošću i sinergijom s beta-laktam antibioticima.
English: Since the reference product is only authorised in Ireland, the concept of the European reference product has been applied in this MRP.
Croatian: U irskoj, koncept europskog referentnog VMP-a primijenjen je u ovom MRP-u.
English: Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Croatian: Znanstveni zaključci i razlozi za dopunu sažetaka opisa svojstava proizvoda, etiketa i uputa za uporabu
English: Latvia Bela-pharm GmbH & Co.KG Lohner Str. 19
Croatian: Bela-pharm GmbH & Co.KG Lohner Str. 19
English: Overall summary of the scientific evaluation of veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene veterinarskomedicinskih lijekova koji sadrže gentamicin dostupan kao otopine za injekciju predviđene za primjenu u konja (vidjeti Prilog I.)
English: The CVMP also considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive when the posology for adult horses (with appropriate warnings and advice on dosing) is changed to: “Single dose of 6.6 mg/kg bw given intravenously once daily for 3-5 consecutive days.
Croatian: CVMP je, također, zaključio da je omjer koristi i rizika za injektibilne veterinarsko-medicinske proizvode koji sadrže gentamicin za konje pozitivan ukoliko se doziranje u odraslih konja (popraćeno odgovarajućim upozorenjima i savjetima o doziranju) promjeni u: „Jedna doza od 6,6 mg/kg tt primijenjena intravenozno jednom dnevno tijekom 3-5 uzastopnih dana.
English: As such, no margin of safety has been established in neonatal foals.
Croatian: Stoga, nije utvrđeno ograničenje sigurne primjene u neonatalne ždrjebadi.
English: Gentamicin sulphate exerts concentration-dependent bacterial killing characteristics.
Croatian: Gentamicin sulfat odlikuje se svojstvima koja ubijaju bakterije ovisno o koncentraciji.
English: The use of the products has been limited to an indication for which gentamicin is considered efficacious on the basis of the data and information available.
Croatian: Mjere za upravljanje rizikom ili smanjivanje rizika Uporaba VMP-ova ograničena je na indikaciju za koju se gentamicin smatra djelotvornim na dostupnih osnovu podataka i informacija.
English: Spain Laboratorios e Industrias IVEN, S.A.
Croatian: Španjolska Laboratorios e Industrias IVEN, S.A.
English: It was understood that the indications would not be unique to these two products and other injectable veterinary medicinal products containing gentamicin for use in horses authorised in the EU have approved different doses, and the concers and considerations would apply equally to these.
Croatian: Mišljenje je da indikacije ne bi bile jedinstvene za ova dva VMP-a i druge injektibilne VMP-ove, koji sadrže gentamicin za primjenu u konja, a odobreni su za stavljanje u promet u EU, te su odobreni za primjenu u različitim dozama.
English: Latvia KELA N.V. St. Lenaartseweg 48 2320 Hoogstraten Belgium
Croatian: Lenaartseweg 48 2320 Hoogstraten Belgija
English: Thus only the scientific questions posed to the CVMP in the referral notification have been considered and are reported below.
Croatian: Stoga se su u obavijesti o upućivanju razmotrena samo znanstvena pitanja upućena CVMP-u, te je o istima izvješteno.
English: Applicant/Marketing Authorisation Holder
Croatian: Podnositelj zahtjeva/ nositelj odobrenja za stavljanje lijeka u promet
English: O-Adenyltransferases (ANT) - catalyses ATP-dependent adenylation of hydroxyl group
Croatian: O-adeniltransferaze (ANT) - katalizira adenilaciju ovisnu o ATP-u hidroksil grupe
English: Gentamicin is a narrow-spectrum Gram-negative bactericidal antimicrobial, without effects on anaerobe bacteria and mycoplasmas.
Croatian: Gentamicin je gram-negativan baktericidni antimikrobik uskog spektra, bez djelovanja na anaerobne bakterije i mikroplazme.
English: Gentamicin is used for first or second choice treatments in a variety of clinical situations in horses.
Croatian: Gentamicin se koristi kao terapija prve ili druge linije u različitim kliničkim situacijama u konja. va kemijska stabilnost ne indikacije.
English: 31303 Burgdorf Germany
Croatian: 31303 Burgdorf Njemačka
English: • on the basis of the available data, the CVMP considered that the indication as provided in Annex III
Croatian: • na osnovu dostupnih podataka, CVMP zaključio da su opravdane indikacije koje su navedene u
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
Croatian: (vidjeti Prilog I.) pozitivan, što je predmetom izmjena informacija o proizvodu; CVMP je preporučio izmjene odobrenja za stavljanje lijeka u promet za veterinarsko-medicinske proizvode koji sadrže gentamicin, a primjenjuju se kao otopine za injekciju za primjenu u konja, sa ciljem izmjene sažetka opisa svojstava VMP-a, etikete i upute o VMP-u kako je navedeno u Prilogu III.
English: Gentamicin does not penetrate intracellularly, or into abscesses.
Croatian: Gentamicin ne penetrira intrastanično ili u apcese.
English: Bovine (calves up to 250 kg), porcine (suckling pigs), equine not intended for human consumption, dogs and cats
Croatian: Goveda (telad do 250 kg), praščići (svinje koje sisaju), konji koji se ne koriste u prehrani ljudi, psi i mačke
English: Gentamicin is deactivated in the presence of inflammatory debris, low oxygen environments and low pH. Gentamicin is eliminated unchanged by the kidney via glomerular filtration, including 85-95% of the dose.
Croatian: Bubrezi eliminiraju nepromijenjen gentamicin putem glomerularne filtracije, uključujući 85-95% doze.
English: 31303 Burgdorf,
Croatian: 31303 Burgdorf, Njemačka
English: Therefore, the CVMP considers that no dosing regimen should be specified for foals, and currently approved dosing regimens for foals should be deleted from the product information, due to lack of target animal safety data especially concerning nephrotoxicity.
Croatian: Stoga je CVMP zaključio da se trebaju obrisati iz informacija o proizvodu, uslijed nedostatka podataka o sigurnoj primjeni u ciljnih životinja, posebice vezano uz nefrotoksičnost.
English: The target animal safety of injectable gentamicin products for horses is considered not proven for use in foals.
Croatian: Zaključeno je kako sigurna primjena u ciljnih životinja injektibilnih VMP-ova koji sadrže gentamicin za konje nije dokazana u ždrjebadi.
English: The CVMP considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive for the following indication: “For the treatment of infections of the lower respiratory tract in horses caused by Gram-negative bacteria susceptible to gentamicin.”
Croatian: CVMP je zaključio da je omjer koristi i rizika za injektibilne veterinarsko-medicinske proizvode koji sadrže gentamicin za konje pozitivan za sljedeću indikaciju: „Za liječenje infekcija donjeg respiratornog trakta u konja uzrokovano aerobnim gram-negativnim bakterijama podložnima gentamicinu.”
English: N-Acetyltransferases (AAC) - catalyses acetyl CoA-dependent acetylation of an amino group
Croatian: N-acetiltransferaze (AAC) - katalizira acetilaciju ovisnu o acetil CoA amino grupe
English: For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin.
Croatian: Za liječenje infekcija nižeg respiratornog trakta u konja uzrokovano aerobnim gram-negativnim bakterijama osjetljivima na gentamicin.
English: The CVMP considered that the lack of data and limited scientific evidence would only support a narrow indication, i.e. “For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin.”
Croatian: Odbor je stoga zaključio kako bi nedostatak podataka i ograničeni znanstveni dokazi podržavali samo uski spektar indikacija, odnosno „Za liječenje infekcija donjeg respiratornog trakta u konja uzrokovano aerobnim gram-negativnim bakterijama podložnima gentamicinu.”
English: It is therefore not recommended to use the product in foals.
Croatian: Stoga, primjena se ne preporučuje primjena proizvoda u ždrjebadi.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Croatian: Izmjene relevantnih dijelova sažetka opisa svojstava, etiketa i uputa o VMP-u
English: Cattle, horses (non-food producing), pigs, dogs and cats
Croatian: Goveda, konji (koji se ne koriste u prehrani ljudi), svinje, psi i mačke
English: Horses declared as not being intended for slaughter for human consumption.
Croatian: Konji koji nisu predviđeni za klanje za prehranu ljudi
English: Two other mechanisms of resistance include ribosomal mutations of the binding site of aminoglycosides, the 30S subunit, and the bacteria decreasing the permeability of aminoglycosides.
Croatian: O-fosfotransferaze (APH) - katalizira fosforilaciju ovisnu o ATP-u hidroksil grupe Druga dva mehanizma rezistencije uključuju ribosomalne mutacije u mjestu vezivanja aminoglikozida, 30S podjedinice i bakterija koje smanjuju permeabilnost aminoglikozida.
English: Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog
Croatian: Goveda, svinje, konji koji nisu predviđeni za klanje za prehranu ljudi, mačke, psi
English: Only one proprietary study in support of the approved dosing regimen for a product included in the scope of this referral was provided.The CVMP considered this study was of limited value to their assessment.
Croatian: Dostavljeno je samo jedno vlasničko ispitivanje u prilog odobrenom režimu doziranja za proizvod uključen u predmet ovog postupka upućivanja.
English: Cattle, horse, swine
Croatian: Goveda, konji, svinje
English: Spain LABORATORIOS MAYMO, S.A.
Croatian: Španjolska LABORATORIOS MAYMO, S.A. Via Augusta, 302
English: Safety of gentamicin has not been established in foals and there is a lack of knowledge of the extra effects of gentamicin on foal kidneys, especially neonates.
Croatian: Još uvijek nije utvrđena sigurna primjena gentamicina u ždrjebadi, te postoji nedostatak znanja dodatnog djelovanja gentamicina na bubrege ždrjebadi, posebice tek neonatalne ždrjebadi. d, posebice neonatalna ždrjebad, izložena većem riziku od nefrotoksičnosti inducirane gentamicinom u usporedbi s odraslim životinjama.
English: The dosing regimen must not be exceeded.” The CVMP considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses negative for use in foals.
Croatian: CVMP je zaključio da je omjer koristi i rizika za injektibilne veterinarsko-medicinske proizvode koji sadrže gentamicin za konje negativan za primjenu u ždrjebadi.