FrancophonIA/ELRC3.0 huggingface dataset:
English: A validated HPLC-MS/MS analytical method was used.
Croatian: Upotrijebljena je validirana HPLCMS/MS analitička metoda.
English: CEVA SANTE ANIMALE 10 Avenue de la Ballastiere 33500 Libourne France
Croatian: Francuska CEVA SANTE ANIMALE 10 Avenue de la Ballastiere 33500 Libourne
English: IAPSA PORTUGUESA PECUÁRIA, LDA Avenida do Brasil nº 88 7º Esq
Croatian: PECUÁRIA, LDA Avenida do Brasil nº 88 7º Esq
English: PASTEUR - Filiala Filipesti SRL
Croatian: Rumunjska PASTEUR - Filiala Filipesti SRL
English: The approved withdrawal period of 146 days was derived using the alternative method with a safety span of 30%, and can be considered as safe for the consumer.
Croatian: Odobreno razdoblje karencije od 146 dana izvedeno je pomoću alternativne metode sa sigurnosnim rasponom od 30 % i može se smatrati sigurnim za potrošače.
English: In that case an extrapolated withdrawal period of 228 days is recommended.
Croatian: U tom slučaju ekstrapolirano preporučeno razdoblje karencije iznosi 228 dana.
English: LABIANA LIFE SCIENCES, S.A.
Croatian: Španjolska LABIANA LIFE SCIENCES, S.A.
English: 1ere Avenue 2065 MLID 06516 Carros Cedex France
Croatian: Francuska VIRBAC 1ere Avenue 2065 MLID 06516 Carros Cedex France
English: PROPHARMA VET d.o.o.
Croatian: PROPHARMA VET d.o.o. Vijenac A.
English: For the target species pigs, three studies were identified from which a sufficiently reliable withdrawal period could be drawn.
Croatian: Za ciljnu vrstu svinje utvrđena su tri ispitivanja na temelju kojih se mogu izvesti dostatno pouzdana razdoblja karencije.
English: No antimicrobial active residues could be detected in any milk sample collected, which is indicative of an overall very rapid depletion.
Croatian: Antimikrobne aktivne rezidue nisu otkrivene ni u jednom od prikupljenih uzoraka mlijeka, što ukazuje na vrlo brzo ukupno izlučivanje.
English: The withdrawal periods are, respectively, 44, 66 and 146 days.
Croatian: Razdoblja karencije iznose 44, 66 i 146 dana.
English: IM, SC (only dogs)
Croatian: IM, SC (samo psi)
English: WPnew = WPold + {log2(Dnew/Dold) x T1/2(final phase)}
Croatian: RKnovo = RKstaro + {log2(Dnova/Dstara) x T1/2(završna faza)}
English: No complete validation data are available.
Croatian: Nisu dostupni potpuni podaci o validaciji.
English: Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections.
Croatian: Gentamicin je aminoglikozidni antibiotik indiciran za liječenje niza bakterijskih infekcija.
English: 19 300 Aspropyrgos mailbox 26
Croatian: Rumunjska Alapis SA 19 300 Aspropyrgos mailbox 26
English: The microbiological assay was adequately validated.
Croatian: Mikrobiološko ispitivanje bilo je primjereno validirano.
English: For that reason it is not possible to use the study to demonstrate a safe withdrawal period, despite the fact that no residues above the sensitivity limit of 100 µg/kg were detected.
Croatian: Iz tog razloga nije moguće upotrijebiti ispitivanje za dokazivanje sigurnog razdoblja karencije, unatoč činjenici da nisu otkrivene rezidue iznad granice detekcije od 100 µg/kg.
English: Moreover the residue depletion period is long for gentamicin, and will in most cases cover a period where animals will at least partly, be ruminating.
Croatian: Osim toga, razdoblje izlučivanja za gentamicin je dugo i u većini slučajeva će obuhvatiti razdoblje kada će životinje barem djelomično preživati.
English: Therefore, on 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs.
Croatian: Belgija je stoga 8. siječnja 2016. pokrenula postupak u skladu s člankom 35. Direktive 2001/82/EZ za veterinarsko-medicinske proizvode koji sadržavaju gentamicin dostupan kao otopine za injekciju za primjenu u goveda i svinja.
English: Can Parellada Industrial
Croatian: Venus, 26. Can Parellada Industrial
English: Indeed, it appears from the available product compositions that products have very similar compositions, including common preservatives and buffer systems which are not likely to influence the absorption rate, and which are present in very low relative amounts.
Croatian: Naime, dostupni sastavi proizvoda upućuju na to da proizvodi imaju vrlo sličan sastav, uključujući zajedničke konzervanse i puferske sustave, za koje je malo vjerojatno da će utjecati na brzinu apsorpcije i koji su prisutni u vrlo malim relativnim količinama.
English: H. For products listed in Annex I for which lactating cows have already been approved as target species
Croatian: Kod proizvoda navedenih u Prilogu I. koji su već dobili odobrenje za krave tijekom laktacije kao ciljnu vrstu
English: Only two animals per slaughter time were involved (14 hours, 7 days, 14 days, 28 days).
Croatian: Za svako predviđeno klanje bile su određene samo dvije životinje (14 sati, 7 dana, 14 dana, 28 dana).
English: Vetoquinol SA Magny-Vernois 70200 Lure France
Croatian: Francuska Vetoquinol SA Magny-Vernois 70200 Lure
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Croatian: Popis nazivâ, farmaceutskog oblika, jačina veterinarskomedicinskih proizvoda, vrsta životinja, putova primjene, podnositelja zahtjeva/nositelja odobrenja za stavljanje u promet u državama članicama
English: Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria
Croatian: Bugarska Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria
English: Overall the data from this study were not considered adequate for the purpose of deriving a milk withdrawal period.
Croatian: Ukupno gledajući, podaci iz ovog ispitivanja nisu smatrani prikladni za svrhu izvođenja razdoblja karencije za mlijeko.
English: The study is not provided as a full report but rather as a summary.
Croatian: Ispitivanje nije dostavljeno u obliku potpunog izvješća, nego kao sažetak.
English: However, in the context of this referral procedure, where products are already authorised and where limited residue depletion data are available, use of this pragmatic approach was considered to be an acceptable way to maintain the availability of medicinal products while ensuring consumer safety.
Croatian: Međutim, u kontekstu ovog postupka upućivanja, kod proizvoda za koje je već izdano odobrenje i ograničenih dostupnih podataka o izlučivanju rezidua smatralo se da je upotreba ovakvog praktičnog pristupa prihvatljiv način da se održi dostupnost veterinarsko-medicinskih proizvoda i istodobno zajamči sigurnost potrošača.
English: Based on the information made available to the CVMP it appears that there are several products for which unclear dosing instructions are given in the product information.
Croatian: Na temelju informacija dostupnih CVMP-u proizlazi da su u informacijama o VMP-u za nekoliko proizvoda navedene nejasne upute za doziranje.
English: The studies were either not GLP-compliant, or the status is unknown.
Croatian: Ispitivanja nisu bila usklađena sa zahtjevima DLP-a ili njihov status nije poznat.
English: Due to a LLOQ which is unclear and possibly higher than the respective MRLs no conclusion can be drawn as to residues in muscle and liver.
Croatian: Zbog LLOQ-a koji je nejasan i možda viši od odgovarajućih najvećih dopuštenih količina, ne mogu se izvesti zaključci o reziduama u mišiću i jetri.
English: Laboratorios e Industrias Iven, S.A.
Croatian: Španjolska Laboratorios e Industrias Iven, S.A.
English: Intramuscular or intravenous use:
Croatian: Intramuskularna ili intravenska primjena:
English: Belgium also noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pigs meat and offal from 28 days to 150 days.
Croatian: Belgija je također primijetila da su diljem Europske unije odobrena različita razdoblja karencije za goveda i svinje kod veterinarsko-medicinskih proizvoda koji sadrže gentamicin dostupan kao otopine za injekciju, npr. za meso i iznutrice goveda od 28 do 210 dana; za mlijeko goveda od 2 do 7 dana, s napomenom „nije za primjenu u krava od kojih se dobiva mlijeko za prehranu ljudi” kod nekih od proizvoda; te za meso i iznutrice svinja od 28 do 150 dana.
English: 4.11 Withdrawal period(s)
Croatian: 4.11 Razdoblje(a) karencije
English: Vijenac A. Cesarca 16 31000 Osijek Croatia
Croatian: Cesarca 16 31000 Osijek Croatia
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU VRSTU, PUT(EVI) i NAČIN PRIMJENE
English: It is not appropriate to pool the residue data in order to calculate an overall withdrawal period for all products as different dosing regimens were applied in the studies.
Croatian: Nije primjereno objedinjavanje podataka o reziduama kako bi se izračunalo ukupno razdoblje karencije za sve proizvode jer su u ispitivanjima primijenjeni različiti režimi doziranja.
English: Indeed, given the especially long persistence of gentamicin in tissues, which is not the case for the other substances in combination products, in view of the withdrawal periods generally approved for products containing trimethoprim and sulphonamides, there is no reason to expect any long-term effect on residues due to interaction.
Croatian: Naime, s obzirom na posebno dugo zadržavanje gentamicina u tkivima, za razliku od drugih tvari u proizvodima s kombinacijom tvari te s obzirom na razdoblja karencije koja su uglavnom odobrena za proizvode koji sadržavaju trimetoprim i sulfonamide, nema razloga očekivati da će zbog interakcije biti bilo kakvih dugotrajnih učinaka na rezidue.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to review all available residue depletion data and recommend withdrawal periods for cattle (meat and milk) and pigs.
Croatian: Zatraženo je da Odbor za veterinarsko-medicinske proizvode (CVMP) pregleda sve dostupne podatke o izlučivanju rezidua i preporuči razdoblja karencije za goveda (meso i mlijeko) i svinje.
English: 08017 Barcelona Spain
Croatian: 08017 Barcelona
English: This relates to a dosing regimen of 4 mg/kg bw each 12 hours for 3 days, and an injection volume of 20 ml for a concentration of 40 mg/ml.
Croatian: To se odnosi na režim doziranja od 4 mg/kg tjelesne težine svakih 12 sati tijekom tri dana i volumen injekcije od 20 ml za koncentraciju od 40 mg/ml.
English: Calves and piglets in the first month of life, horses declared as not intended for slaughter for human consumption
Croatian: Telad i prasad u prvom mjesecu života, konji koji nisu predviđeni za klanje za prehranu ljudi
English: Lithuania Interchemie werken "de Adelaar" B.V.
Croatian: Bugarska Interchemie werken "de Adelaar" B.V.
English: Taking a pragmatic approach intended to preserve product availability in lactating cows while ensuring consumer safety, it is considered appropriate to apply to the maximum milk withdrawal period currently authorised, i.e., 7 days, to all products that have lactating cows as an indicated species.
Croatian: Uz praktičan pristup kojem je cilj održati dostupnost VMP-a u krava tijekom laktacije i istodobno zajamčiti sigurnost potrošača, smatra se primjerenim primijeniti najdulje trenutačno odobreno razdoblje karencije, tj. sedam dana, na sve proizvode u kojima su kao vrsta navedene krave u razdoblju laktacije.
English: No full study report and analytical method validation report are available.
Croatian: Nije dostupno cjelovito izvješće o ispitivanju ni izvješće o validaciji analitičke metode.
English: Residue concentrations in milk were determined 12, 24, 36, 48, 60, 72, 84 and 96 hours after the last administration.
Croatian: Koncentracije rezidua u mlijeku utvrđene su 12, 24, 36, 48, 60, 72, 84 i 96 sati nakon posljednje primjene.
English: Calves and piglets up to one month old
Croatian: Telad i prasad do jednog mjeseca starosti
English: The analytical method used liquid-liquid chromatography with fluorometric detection but data demonstrating the validity of the method were not available; only 3 of the 4 recommended gentamicin marker residue components were monitored.
Croatian: U analitičkoj metodi korištena je tekućina - tekućinska kromatografija s fluorimetrijskim detektorom, ali nisu dostupni podaci koji dokazuju valjanost metode; praćene su samo tri od četiri preporučene komponente markera rezidua gentamicina.
English: Only one product (Gentamicin Bremer Pharma, authorised in Latvia, MAH: Bremer Pharma) recommends a higher total dose, of 80 mg gentamicin base per kg bw.
Croatian: Samo jedan VMP (Gentamicin Bremer Pharma, odobren u Latviji, nositelj odobrenja za stavljanje VMPa u promet: Bremer Pharma) preporučio je veću ukupnu dozu, od 80 mg gentamicina po kg tjelesne težine.
English: The GLP status of the study is not known.
Croatian: DLP status ispitivanja nije poznat.
English: On day 112 after the last injection, the last time point, all concentrations were below the MRL.
Croatian: Na posljednjoj vremenskoj točki, 112 dana nakon posljednje injekcije, sve koncentracije bile su ispod NDK-a.
English: Cattle (calves up to 250kg)
Croatian: Goveda (telad do 250 kg)
English: In addition the period over which depletion takes place is very long, and all products concerned by this referral are aqueous solutions.
Croatian: Osim toga, razdoblje tijekom kojeg dolazi do izlučivanja vrlo je dugo, a svi proizvodi na koje se ovo upućivanje odnosi jesu vodene otopine.
English: As expected in view of the dose administered, depletion appears rapid in all tissues and levels were below the MRL at the first time point, i.e. 40 days.
Croatian: Kako se i očekivalo, s obzirom na primijenjenu dozu, izlučivanje je bilo brzo u svim tkivima i razine su bile ispod NDK-a na prvoj vremenskoj točki, tj. 40. dana.
English: The study meets current standards, although the analytical method was microbiological and no control surrounding injection site sample was collected (on the other hand, two injection sites per animal, one on each side, were analysed).
Croatian: Ispitivanje zadovoljava postojeće standarde, iako je analitička metoda bila mikrobiološka i nisu uzeti kontrolni uzorci okolnog područja mjesta injiciranja (s druge strane, provedena je analiza dvaju mjesta injiciranja po životinji, svakog s
English: It is noted that the dose used in the relevant study (50 mg gentamicin base per kg bw) appears to cover all of the currently recommended dosing regimens.
Croatian: Napominje se da doza primijenjena u odgovarajućem ispitivanju (50 mg gentamicina po kg tjelesne težine) obuhvaća sve režime doziranja koji su trenutačno preporučeni.
English: VetProm JSC 26, Otets Paisii Str 2400 Radomir Bulgaria
Croatian: Bugarska VetProm JSC 26, Otets Paisii Str 2400 Radomir
English: The withdrawal period derived from those data, based on the alternative method with a 10% safety span, and relating to a single dose of 5 mg/animal, is 44 days for piglets.
Croatian: Razdoblje karencije za prasad izvedeno iz tih podataka na temelju alternativne metode s 10 % sigurnosnog raspona, pri jednokratnoj dozi od 5 mg po životinji, iznosi 44 dana.
English: Germany Eurovet Animal Health B.V. Handelsweg 25
Croatian: Njemačka Eurovet Animal Health B.V.
English: KRKA, d.d.
Croatian: Slovenija KRKA, d.d.
English: Where: WPnew is the withdrawal period for the product for which a withdrawal period is to be derived; WPold is the withdrawal period for the product from which extrapolation is proposed; Dnew is the dose of the product for which a withdrawal period is to be derived; Dold is the dose of the product from which extrapolation is proposed; T1/2(final phase) is the terminal half-life.
Croatian: Gdje je: RKnovo razdoblje karencije za proizvod koje treba izvesti; RKstaro je razdoblje karencije za proizvod na temelju kojeg je predložena ekstrapolacija; Dnova je doza proizvoda za kojeg treba izvesti razdoblje karencije; Dstara je doza proizvoda na temelju kojeg je predložena ekstrapolacija; T1/2 (završna faza) je terminalni poluvijek.
English: 4.9 Amounts to be administered and administration route
Croatian: 4.9 Količine koje je potrebno primijeniti i način primjene
English: In the case of pigs, all withdrawal periods determined relate to a maximum injected volume of 1 ml, for a concentration of 50 mg/ml, and cannot be directly extrapolated either to larger volumes or to larger doses per injection site.
Croatian: U slučaju svinja, sva utvrđena razdoblja karencije odnose se na najveći volumen injekcije od 1 ml za koncentraciju od 50 mg/ml i ne mogu se izravno ekstrapolirati na veće volumene injekcija ili veće doze po mjestu injiciranja.
English: The low number of animals and data points did not allow analysis of the results using the TTSC (time to safe concentration) or SCLR (safe concentrations, based on linear regression, and allowing for measurements below the limit of quantification) statistical methods, as per CVMP Note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98)
Croatian: Mali broj životinja i podatkovnih točaka onemogućio je analizu rezultata pomoću statističkih metoda, TTSC-a (metoda mjerenja do sigurne koncentracije) ili SCLR-a (sigurne koncentracije na temelju linearne regresije uz mjerenja ispod granice kvantifikacije), prema uputama CVMP-a za smjernice o određivanju razdoblja karencije za mlijeko (EMEA/CVMP/473/98)
English: Quality, target animals safety, user safety, environmental risk and efficacy have not been assessed in this referral procedure.
Croatian: U ovom postupku upućivanja nije provedena procjena kakvoće, sigurnosti ciljanih životinja, sigurnosti za korisnike, rizika za okoliš i djelotvornosti.
English: This is confirmed to some extent by the rapid depletion observed with Forticine Solution 1% (MAH: Vetoquinol), also conducted in young calves fed with milk replacer.
Croatian: To u određenoj mjeri potvrđuje brzo izlučivanje zabilježeno kod VMP-a Forticine Solution 1% (nositelj odobrenja za stavljanje VMP-a u promet: Vetoquinol), koji je također primijenjen u mlade teladi koja su dobivala mliječnu zamjenicu.
English: Therefore, the injection volume should be limited to a maximum of 1 ml per injection site, or to 50 mg gentamicin per injection site for products with a strength exceeding 50 mg gentamicin per ml.
Croatian: Stoga bi volumen injekcije trebao biti ograničen na najviše 1 ml po mjestu injiciranja ili na 50 mg gentamicina po mjestu injiciranja kod proizvoda čija jačina premašuje 50 mg gentamicina po ml.
English: Furthermore, data available in Belgium for comparable products clearly indicate that residue levels can be above the maximum residue limits (MRLs) at the proposed withdrawal periods.
Croatian: Nadalje, dostupni podaci za usporedive proizvode u Belgiji jasno ukazuju na to da razine rezidua kod predloženih razdoblja karencije mogu biti iznad najvećih dopuštenih količina rezidua (NDK).
English: However, in view of the residues above the MRL in liver at day 89, and given that no full study report is available and no analytical method validation report is available, it is not possible to derive a withdrawal period from the study.
Croatian: Međutim, s obzirom na to da su rezidue u jetri 89. dana bile iznad najveće dopuštene količine te da nije dostupno cjelovito izvješće o ispitivanju kao ni izvješće o validaciji analitičke metode, nije moguće izvesti razdoblje karencije iz ovog ispitivanja.
English: The analytical method was a bacteriological assay for which adequate validation data were not available, with a LLOQ of 100 µg/kg, i.e., twice the current applicable MRL (50 µg/kg for muscle).
Croatian: Analitička metoda bila je bakteriološko ispitivanje za koje nema odgovarajućih podataka o validaciji, a LLOQ je bio 100 µg/kg, tj. dvostruko veći od trenutačno primjenjive najveće dopuštene količine (50 µg/kg za mišić).
English: Residue depletion was only followed in kidney and liver; notably the injection site was not analysed.
Croatian: Izlučivanje rezidua praćeno je samo u bubrezima i jetri; nije provedena analiza mjesta injekcije.
English: Indeed, the concerned products are for parenteral injection and therefore the impact of digestive physiology is likely limited.
Croatian: Naime, dotični proizvodi namijenjeni su za parenteralnu primjenu (injiciranje) te je vjerojatno da probavna fiziologija ima ograničen utjecaj.
English: Therefore, the withdrawal periods cannot be extrapolated to higher injection volumes than those applied in the studies.
Croatian: Stoga se ne može provesti ekstrapolacija za razdoblja karencije kod većih volumena injekcije od onih primijenjenih u ispitivanjima.
English: The study involved calves of less than 1 month of age.
Croatian: Ispitivanje je obuhvaćalo telad u dobi manjoj od jednog mjeseca.
English: Calves (up to 13 weeks of age)
Croatian: Telad (do 13 tjedana starosti)
English: Therefore, Belgium considered that consumer safety is not ensured by the withdrawal periods set for the reference product Genta 100 mg/ml (marketing authorisation holder (MAH): CP-Pharma) and consequently, for its generic product Emdogent 100 (applicant: Emdoka).
Croatian: Stoga je Belgija zaključila da nije zajamčena sigurnost potrošača pri razdobljima karencija koja su određena za referentni VMP Genta 100 mg/ml (nositelj odobrenja za stavljanje VMP-a u promet: CP-Pharma) i slijedom toga, za generički VMP Emdogent 100 (podnositelj zahtjeva: Emdoka).
English: • the CVMP considered that the overall benefit-risk balance for the products under this procedure remains positive subject to amendments in the product information;
Croatian: • CVMP zaključio da ukupan omjer koristi i rizika proizvoda iz ovog postupka ostaje pozitivan, no predmetom je izmjena u informacijama o VMP-u;
English: However, it appears from all the data taken together that, at least for an injection volume of up to 20 ml in calves, the injection site is not the limiting tissue and therefore, it may be considered that the risk for the consumer in relation to higher injection volumes would remain low.
Croatian: Međutim, ukupni podaci upućuju na to da se, barem kad je riječ od volumenu injekcije do 20 ml u teladi, za mjesto injiciranja ne utvrđuje NDK te se stoga može zaključiti da bi rizik za potrošače s obzirom na veći volumen injekcije ostao nizak.
English: Huvepharma AD 33 James Boucher Blvd. Sofia 1407
Croatian: Huvepharma AD 33 James Boucher Blvd.
English: The statistical method could not be applied as, for all edible tissues, an insufficient number of data points were available.
Croatian: Nije bilo moguće primijeniti statističku metodu zbog nedostatnog broja dostupnih podatkovnih točaka za sva jestiva tkiva.
English: Gentamicin residues in edible tissues and milk were determined by a microbiological assay with a limit of quantification being 50 μg/kg (1/2 MRL).
Croatian: Rezidue gentamicina u jestivim tkivima i mlijeku utvrđene su mikrobiološkim ispitivanjem s granicom kvantifikacije od 50 μg/kg (1/2 NDK).
English: Some of the concerned products may be used in older animals than those used in the studies, leading to higher total injection volumes, which may entail a slowest depletion rate due to the decreased surface/volume ratio of the injection site bolus.
Croatian: Neki od dotičnih proizvoda mogli bi biti primijenjeni na životinjama starijim od onih na kojima je provedeno ispitivanje, što dovodi do većeg ukupnog volumena injekcije, te bi moglo rezultirati najsporijom stopom izlučivanja zbog smanjenog omjera površine i volumena bolusa na mjestu injiciranja.
English: The study was conducted in ruminating cattle (350-380 kg) and pigs of 35-40 kg.
Croatian: Ispitivanje je provedeno na govedima koja preživaju (350380 kg) i svinjama od 35 do 40 kg težine.
English: However in view of the overall data available on gentamicin residue depletion, it is known that fat and muscle (except injection site muscle) are not limiting tissues.
Croatian: Međutim, s obzirom na ukupne dostupne podatke o izlučivanju rezidua gentamicina, poznato je da se za masno tkivo i mišić (osim mišića na mjestu injiciranja) ne utvrđuje NDK.