FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, the comparison of the studies with Aagent 50 mg/ml solution for injection (MAH: Fatro) and Genta-ject 10% (MAH: Dopharma) shows that residue depletion is not slower in very young animals, since the withdrawal period is lower (103 days) for calves less than one month of age receiving a milk replacer and a solid supplement, than for older calves receiving solid food.
Slovenian: Nadalje primerjava študij, opravljenih z zdraviloma Aagent 50 mg/ml raztopina za injiciranje (imetnik dovoljenja za promet: Fatro) in Genta-ject 10% (imetnik dovoljenja za promet: Dopharma), kaže, da izločanje ostankov pri zelo mladih živalih ni počasnejše, saj je karenca pri teletih, mlajših od enega meseca, ki prejemajo mlečni nadomestek in dodatek v trdni obliki, krajša (103 dni) kot pri starejših teletih, ki prejemajo trdno hrano.
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.
Slovenian: To v določeni meri potrjuje tudi hitro izločanje zdravila Forticine Solution 1% (imetnik dovoljenja za promet: Vetoquinol), opaženo v študiji, opravljeni z mladimi teleti, hranjenimi z mlečnim nadomestkom.
English: In kidney, at the last time point i.e., 28 days after the last administration, all residue concentrations were below the current MRL value, although they remained relatively close to the MRL (680 and 700 µg/kg).
Slovenian: V ledvicah so bile v zadnji časovni točki, tj. 28 dni po zadnjem odmerku, vse koncentracije ostankov pod trenutno najvišjo mejno vrednostjo ostanka, vendar so ostajale sorazmerno blizu najvišji mejni vrednosti (680 oziroma 700 µg/kg).
English: KRKA, d.d.
Slovenian: Slovenija KRKA, d.d.
English: The intention is to address those products concerned by this procedure for which the maximum recommended dose is high and for which no withdrawal period can be set in a conventional manner based on residue data.
Slovenian: Namen tega postopka je obravnavati tista zadevna zdravila, za katera je največji priporočeni odmerek velik in za katera na podlagi podatkov o ostankih ni mogoče določiti karence na običajen način.
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.
Slovenian: Zato je treba volumen injiciranja omejiti na največ 1 ml na mesto injiciranja oziroma 50 mg gentamicina na mesto injiciranja za zdravila z jakostjo, ki presega 50 mg gentamicina na ml.
English: The overall benefit-risk balance of the products under this procedure was deemed positive subject to the recommended amendments in the product information (see Annex III).
Slovenian: Splošno razmerje med tveganji in koristmi za zdravila iz te napotitve je bilo ocenjeno kot pozitivno, pod pogojem, da se upoštevajo priporočene spremembe informacij o zdravilu (glejte Prilogo III).
English: The withdrawal periods are, respectively, 44, 66 and 146 days.
Slovenian: Karence so 44, 66 oziroma 146 dni.
English: That study in piglets is GLP-compliant; the design is in accordance with current standards.
Slovenian: Ta študija, opravljena pri prašičkih, je skladna z dobro laboratorijsko prakso, njena zasnova pa je v skladu s trenutnimi standardi.
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.
Slovenian: Tudi podatki, ki so v Belgiji na voljo za primerljiva zdravila, jasno kažejo, da so vrednosti ostankov po preteku predlagane karence lahko nad najvišjo mejno vrednostjo ostanka.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje za dajanje govedu in prašičem (glejte Prilogo I)
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).
Slovenian: Zato je Belgija menila, da varnost potrošnikov s karenco, določeno za referenčno zdravilo Genta 100 mg/ml (imetnik dovoljenja za promet z zdravilo (imetnik dovoljenja za promet: CPPharma), in torej tudi za generično zdravilo Emdogent 100 (predlagatelj: Emdoka), ni zagotovljena.
English: Germany Eurovet Animal Health B.V. Handelsweg 25
Slovenian: Eurovet Animal Health B.V.
English: It can be considered that this withdrawal period is sufficient to cover differences in product composition that could have an impact on the residue depletion pattern.
Slovenian: Lahko se šteje, da je omenjena karenca zadostna, da zajame razlike v sestavi zdravil, ki bi lahko imele vpliv na vzorec izločanja ostankov.
English: Due to the size of the animals no control surrounding injection site sample could be collected.
Slovenian: Zaradi velikosti živali ni bilo mogoče odvzeti vzorca iz okolice mesta injiciranja.
English: the CVMP has recommended variations of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs (see Annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Slovenian: odbor CVMP je priporočil spremembo dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje za dajanje govedu in prašičem (glejte Prilogo I), in sicer je treba popraviti povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.
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.
Slovenian: To se nanaša na shemo odmerjanja z odmerkom 4 mg/kg telesne mase na 12 ur v obdobju 3 dni in volumnom injiciranja 20 ml s koncentracijo 40 mg/ml.
English: IAPSA PORTUGUESA PECUÁRIA, LDA Avenida do Brasil nº 88 7º Esq
Slovenian: Avenida do Brasil nº 88 7º Esq
English: For products where the total dose exceeds that for which reliable residues data are available (i.e., for products administered at total doses of greater than 24 mg gentamicin base per kg bw in cattle) the CVMP agreed to extrapolate withdrawal periods based on pharmacokinetic principles.
Slovenian: Za zdravila, pri katerih skupni odmerek presega odmerek, za katerega so na voljo zanesljivi podatki o ostankih (tj. za zdravila, dana v skupnem odmerku več kot 24 mg gentamicinijeve baze na kg telesne mase pri govedu), se je odbor CVMP dogovoril, da se karenca ekstrapolira na podlagi farmakokinetičnih načel.
English: The same rationale used as a basis for the withdrawal periods for products containing gentamicin as the sole active substance may also be applied to gentamicin in combination with trimethoprim and sulfadimethoxine.
Slovenian: Enaka utemeljitev, uporabljena za karence za zdravila, ki vsebujejo gentamicin kot edino zdravilno učinkovino, se lahko uporabi tudi pri kombinacijah gentamicina s trimetoprimom in sulfadimetoksinom.
English: Therefore, the withdrawal periods cannot be extrapolated to higher injection volumes than those applied in the studies.
Slovenian: Zato karenc ni mogoče ekstrapolirati na volumne injiciranja, ki so večji od volumnov, uporabljenih v študijah.
English: Following a marketing authorisation application to the Belgian Federal Agency for Medicines and Health Product, under Article 13(1) of Directive 2001/82/EC as amended, i.e., a generic application, it appeared that no product-specific residue data were generated in support of the cattle and pigs' meat and offal withdrawal periods for the reference product Genta 100 mg/ml, as authorised in Germany.
Slovenian: Po vložitvi vloge za pridobitev dovoljenja za promet z zdravilom pri belgijski zvezni agenciji za zdravila in zdravstvene izdelke v skladu s členom 13(1) Direktive 2001/82/ES, kakor je bila spremenjena, tj. generične vloge, se je izkazalo, da v podporo karence za goveje in prašičje meso in organe za referenčno zdravilo Genta 100 mg/ml, ki ima dovoljenje za promet v Nemčiji, ni bilo pridobljenih nobenih za zdravilo specifičnih podatkov o ostankih.
English: The study for Genta-kel 5% (MAH: Kela) in piglets used a dose of 3 mg/kg bw twice daily; the treatment duration could not be identified.
Slovenian: V študiji z zdravilom Genta-kel 5% (imetnik dovoljenja za promet: Kela) pri prašičkih so uporabljali odmerek 3 mg/kg telesne mase dvakrat na dan; trajanja zdravljenja ni bilo mogoče ugotoviti.
English: However, the subcutaneous route should no longer be recommended for cattle and pigs since the depletion kinetics from the injection site remains unknown and may be limiting.
Slovenian: Vendar pa se subkutana uporaba ne sme več priporočati za govedo in prašiče, saj kinetika izločanja z mesta injiciranja še vedno ni znana in je morda omejujoča.
English: The products Forticine Solution 1% and 4% (MAH: Vetoquinol), were investigated in one main study focusing kidney, liver and muscle, and using the 1% solution, and one confirmatory study using the
Slovenian: Zdravili Forticine Solution 1 % in 4 % (imetnik dovoljenja za promet: Vetoquinol) so proučevali v glavni študiji, ki se je osredotočala na ledvice, jetra in mišice, z uporabo 1-odstotne raztopine.
English: A warning sentence should be added to the product information to advise that any repeated course of treatment during the withdrawal period must be avoided.
Slovenian: V informacije o zdravilu je treba dodati opozorilni stavek, ki navaja, da se je treba v času karence izogibati ponovljenemu zdravljenju.
English: It is considered that the withdrawal periods of 103, 192 and 139 days should be applied to the aforementioned specific products used in the corresponding studies, insofar as the recommended dosing regimen is identical to the one applied in the relevant study, or amounts to a lesser or equivalent dosing in terms of total exposure.
Slovenian: Velja, da je treba karence 103, 192 oziroma 139 dni uporabljati za specifična zgoraj navedena zdravila, ki so jih uporabljali v zadevnih študijah, če je priporočena shema odmerjanja enaka kot v zadevni študiji ali če je odmerek v smislu celotne izpostavljenosti manjši ali enak.
English: The SCPM (safe concentrations, based on data per time point, allowing for data below the limit of quantification) method resulted in a calculated withdrawal period of 72 hours, which corresponds to the first time points where all concentrations are below the MRL, although residues were below the MRL for 7 out of 8 animals at 48 hours after the last administration.
Slovenian: Z metodo SCPM (varne koncentracije na podlagi podatkov na časovno točko, ki omogočajo pridobitev podatkov pod mejo določljivosti) so izračunali karenco 72 ur, kar ustreza prvim časovnim točkam, ko so vse koncentracije pod najvišjo mejno vrednostjo ostanka, čeprav so bili ostanki pod najvišjo mejno vrednostjo ostanka pri 7 od 8 živali že po 48 urah po zadnjem odmerku.
English: Using the data available in the CVMP EPMAR for gentamicin (EMEA/MRL/803/01)
Slovenian: Z uporabo podatkov, ki so na voljo v evropskem javnem poročilu o najvišji mejni vrednosti ostankov (EPMAR) za gentamicin Odbora za zdravila za uporabo v veterinarski medicini (CVMP) (EMEA/MRL/803/01)
English: The pharmacokinetic approach uses the observed terminal depletion half-life in tissues, the withdrawal period established based on data, and the dose to be administered to allow derivation of withdrawal periods, according to the following formula:
Slovenian: Farmakokinetični pristop uporablja opaženo razpolovno dobo končnega izločanja iz tkiv, karenco, ugotovljeno na podlagi teh podatkov, in odmerek, ki ga je treba dati, da bi lahko izpeljali karence v skladu z naslednjo formulo:
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).
Slovenian: Ostanke gentamicina v užitnih tkivih in mleku so določali z mikrobiološkim testom z mejo določljivosti 50 μg/kg (1/2 najvišje mejne vrednosti ostanka).
English: Any such impact is likely to remain limited in view of the available product compositions, given the very long period over which depletion takes place, and given that all products concerned by this referral are aqueous solutions.
Slovenian: Glede na sestavo razpoložljivih zdravil je takšen vpliv verjetno omejen, saj izločanje poteka zelo počasi in vsa zdravila, na katera se nanaša ta napotitev, so vodne raztopine.
English: It is considered that the intravenous route is unlikely to lead to higher residue levels in comparison to the intramuscular route and consequently the withdrawal periods derived based on subcutaneous administration can also be recommended for intravenous administration.
Slovenian: Velja, da ni zelo verjetno, da bi intravenska uporaba povzročila višje ravni ostankov kot intramuskularna uporaba, zato se lahko karence, izpeljane na podlagi subkutanega dajanja, priporočijo tudi za intravensko dajanje.
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.
Slovenian: Npr. karenca za goveje meso in organe je od 28 dni do 210 dni, za kravje mleko od 2 dni do 7 dni, pri čemer je za nekatera zdravila navedeno „ne uporabljajte pri kravah, katerih mleko je namenjeno za prehrano ljudi“, za prašičje meso in organe pa od 28 dni do 150 dni.
English: Groups of cattle were slaughtered 60, 70, 80 and 90 days after the last administration.
Slovenian: Skupine goveda so zaklali 60, 70, 80 oziroma 90 dni po zadnjem odmerku.
English: For products for which the maximum recommended dose is below that used in the worst case residues studies (24 mg gentamicin base per kg bw), use of this extrapolation approach is not considered appropriate, as using the highest calculated withdrawal period has the effect of incorporating an overall safety margin to cover the lack of specific and adequate data.
Slovenian: Za zdravila, pri katerih je največji priporočeni odmerek manjši od odmerka, uporabljenega v študijah ostankov za najslabše primere (24 mg gentamicinijeve baze na kg telesne mase), uporaba tega pristopa z ekstrapolacijo ni ustrezna, saj z uporabo najdaljše izračunane karence vključimo celokupno varnostno mejo, ki nadomesti pomanjkanje specifičnih in ustreznih podatkov.
English: At the last time point i.e., day 89, residues above the MRL were still detected in the liver (2 in 5 samples).
Slovenian: V zadnji časovni točki, tj. 89. dan, so v jetrih še vedno zaznali ostanke nad najvišjo mejno vrednostjo ostanka (pri 2 od 5 vzorcev).
English: Dopharma B.V.
Slovenian: Dopharma Research B.V.
English: In veterinary medicine gentamicin is used mainly as a solution for injection for cattle, pigs, horses, cats and dogs.
Slovenian: V veterinarski medicini se gentamicin večinoma uporablja v obliki raztopine za injiciranje za govedo, prašiče, konje, pse in mačke.
English: Animals were slaughtered at 4, 11, 20, and 89 days after the last administration, in groups of 4 to 5.
Slovenian: Živali so zaklali 4, 11, 20 oziroma 89 dni po zadnjem odmerku, in sicer v skupinah po 4 do 5.
English: The dose received was 3 mg/kg bw every 8 hours for 3 days.
Slovenian: Prejeti odmerek je bil 3 mg/kg telesne mase na 8 ur v obdobju 3 dni.
English: In addition, for the injection site, one concentration was still slightly above the MRL at day 49.
Slovenian: Poleg tega je bila ena koncentracija na mestu injiciranja 49. dan še vedno nekoliko nad najvišjo mejno vrednostjo ostanka.
English: In addition the period over which depletion takes place is very long, and all products concerned by this referral are aqueous solutions.
Slovenian: Poleg tega izločanje poteka zelo počasi in vsa zdravila, na katera se nanaša ta napotitev, so vodne raztopine.
English: • a repeated course of treatment within a certain timescale is highly likely to lead to accumulation of gentamicin residues in liver, kidneys, and potentially injection sites of treated animals, the CVMP considered that a warning sentence should be added to the product information to advise that any repeated course of treatment during the withdrawal period must be avoided;
Slovenian: • ponovljeno zdravljenje v določenem časovnem okviru zelo verjetno povzroči kopičenje ostankov gentamicina v jetrih, ledvicah in morda na mestih injiciranja zdravljenih živali, zato je odbor CVMP presodil, da je treba v informacije o zdravilu dodati opozorilni stavek, ki navaja, da se je treba v času karence izogibati ponovljenemu zdravljenju;
English: Residue depletion data in cattle milk
Slovenian: Podatki o izločanju ostankov za kravje mleko
English: The study involves non ruminating calves of 8-11 weeks of age, which received 3 mg/kg bw gentamicin twice a day for 3 consecutive days.
Slovenian: Študija vključuje teleta pred začetkom prežvekovanja, stara 8-11 tednov, ki so prejemala gentamicin v odmerku 3 mg/kg telesne mase dvakrat na dan v obdobju 3 dni zaporedoma.
English: The subcutaneous route should no longer be recommended for cattle and pigs since the depletion kinetics from the injection site remains unknown and may be limiting.
Slovenian: Subkutana uporaba se za govedo in prašiče ne sme več priporočati, saj kinetika izločanja z mesta injiciranja še vedno ni znana in je morda omejujoča.
English: The 192 days withdrawal period was established in ruminating animals; however the Committee considers that it is applicable also to non-ruminating calves.
Slovenian: Karenca 192 dni je bila določena za prežvekovalne živali, vendar odbor CVMP meni, da velja tudi za teleta pred začetkom prežvekovanja.
English: Due to accumulation of gentamicin in liver, kidneys and injection site, any repeated course of treatment during the withdrawal period must be avoided.
Slovenian: Zaradi kopičenja gentamicina v jetrih, ledvicah in na mestu injiciranja se je treba ponovnemu zdravljenju v času karence izogibati.
English: • on the basis of the residue depletion data in cattle and pigs, the CVMP considered the withdrawal periods for cattle (meat and milk) and pigs should be amended to provide assurance for consumer safety;
Slovenian: • na podlagi podatkov o izločanju ostankov pri govedu in prašičih je odbor CVMP presodil, da je treba zaradi zagotavljanja varnosti potrošnikov karence za govedo (meso in mleko) in prašiče spremeniti;
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Slovenian: Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
English: It is concluded that the withdrawal periods of 44, 66 and 146 days should be applied to the aforementioned products used in the corresponding studies, insofar as the recommended dosing regimen is identical to the one applied in the relevant study, or amounts to a lesser or equivalent dosing in terms of total exposure.
Slovenian: Velja, da je treba karence 44, 66 oziroma 146 dni uporabljati za omenjena zdravila, ki so jih uporabljali v zadevnih študijah, če je priporočena shema odmerjanja enaka kot v zadevni študiji ali če je odmerek v smislu celotne izpostavljenosti manjši ali enak.
English: This calculation is applicable provided that the depletion kinetics are linear and that when residues deplete below the MRLs, the tissue distribution is complete.
Slovenian: Ta izračun velja pod pogojem, da je kinetika izločanja linearna in da je porazdelitev v tkivih zaključena, ko je vrednost izločenih ostankov pod najvišjo mejno vrednostjo ostanka.
English: No control surrounding sample was collected for the injection site, but 2 sites per animal were analysed and the sites were considered as sufficiently close to each other.
Slovenian: Iz okolice mesta injiciranja niso odvzeli vzorca, vendar so analizirali po 2 mesti na posamezno žival, ki sta bili dovolj blizu eno drugemu.
English: B-2370 Arendonk Belgium
Slovenian: Hoge Mauw 900 B-2370 Arendonk Belgium
English: In the confirmatory, injection site study no control surrounding sample was collected but 3 injection sites per animal were used, in 6 animals.
Slovenian: V potrditveni študiji mesta injiciranja niso odvzeli kontrolnega vzorca iz okolice, vendar so uporabili po 3 mesta injiciranja na posamezno žival, in sicer pri 6 živalih.
English: The study meets current standards, although fat and muscle (other than injection site) were not analysed.
Slovenian: Študija ustreza trenutnim standardom, čeprav niso analizirali maščobe in mišic (razen na mestu injiciranja).
English: Overall for the species cattle, three studies allow derivation of withdrawal periods of 103 days for Aagent 50 mg/ml (MAH: Fatro), 192 days for Gentacalier 40 mg/ml, Maycoli inyectable 40 mg/ml, Gentavall 40 mg/ml, Vetersan gentamicina 40 mg/ml, Gentamiciven 40 mg/ml and Purmicina 40 mg/ml (MAHs: Laboratorios Calier, Laboratorios Maymo, Super's Diana, Mevet, Laboratorios e Industrias Iven and Cenavisa), and 139 days for Genta-ject 10% (MAH: Dopharma).
Slovenian: Skupaj izpeljavo karence za govedo omogočajo tri študije, in sicer karenco 103 dni za zdravilo Aagent 50 mg/ml (imetnik dovoljenja za promet: Fatro), 192 dni za zdravila Gentacalier 40 mg/ml, Maycoli inyectable 40 mg/ml, Gentavall 40 mg/ml, Vetersan gentamicina 40 mg/ml, Gentamiciven 40 mg/ml in Purmicina 40 mg/ml (imetniki dovoljenj za promet: Laboratorios Calier, Laboratorios Maymo, Super's Diana, Mevet, Laboratorios e Industrias Iven in Cenavisa) ter 139 dni za zdravilo Genta-ject 10% (imetnik dovoljenja za promet: Dopharma).
English: In all residue depletion studies submitted, gentamicin was used as an injectable aqueous solution and was administered by the intramuscular route.
Slovenian: Pri vseh predloženih študijah izločanja ostankov se je gentamicin uporabljal v obliki vodne raztopine za injiciranje in se je dajal intramuskularno.
English: E. For Gentamicin Bremer Pharma listed in Annex I (Marketing Authorisation Holder: Bremer Pharma GmbH)
Slovenian: E. Za zdravilo Gentamicin Bremer Pharma, navedeno v Prilogi I (imetnik dovoljenja za promet z zdravilom: Bremer Pharma GmbH)
English: Gentaprim trimethoprim gentamicin sulfadimethoxin
Slovenian: Gentaprim trimetoprim gentamicin sulfadimetok sin
English: It is of note that the withdrawal period of 44 days in piglets based on the study with Gentavall 5 mg/ml (MAH: Mevet) corresponds to very particular conditions of use (one single 5 mg injection in neonates).
Slovenian: Poudariti je treba, da karenca 44 dni pri prašičkih na podlagi študije z zdravilom Gentavall 5 mg/ml (imetnik dovoljenja za promet: Mevet) ustreza le zelo posebnim pogojem uporabe (enkratna 5 mg injekcija pri novorojenih prašičkih).
English: A GLP compliant study conducted with Gentamicina 4% solucion inyectabile (applicable for Gentacalier 40 mg/ml, Maycoli inyectable 40 mg/ml, Gentavall 40 mg/ml, Vetersan gentamicina 40 mg/ml, Gentamiciven 40 mg/ml and Purmicina 40 mg/ml (MAHs: Laboratorios Calier, Laboratorios Maymo, Super's Diana, Mevet, Laboratorios e Industrias Iven and Cenavisa)) was provided.
Slovenian: Predložena je bila študija, opravljena v skladu z dobro laboratorijsko prakso, z zdravilom Gentamicina 4% solucion inyectabile (ki velja za zdravila Gentacalier 40 mg/ml, Maycoli inyectable 40 mg/ml, Gentavall 40 mg/ml, Vetersan gentamicina 40 mg/ml, Gentamiciven 40 mg/ml in Purmicina 40 mg/ml (imetniki dovoljenj za promet: Laboratorios Calier, Laboratorios Maymo, Super's Diana, Mevet, Laboratorios e Industrias Iven in Cenavisa)).