FrancophonIA/ELRC3.0 huggingface dataset:
English: Qualitative and quantitative composition
Slovenian: Kakovostna in količinska sestava
English: Meat and offal: 107 days.
Slovenian: Meso in organi: 107 dni.
English: Finally, consideration has been given to the analytical methods that were used.
Slovenian: Končno sta bili obravnavani tudi uporabljeni analizni metodi.
English: Information was received regarding the composition of the affected products (n = 5).
Slovenian: Prejete so bile informacije o sestavi zadevnih zdravil (n = 5).
English: The reasoning being that:
Slovenian: Ob upoštevanju naslednjega:
English: In addition, different breeds of sheep were used in each of the studies provided.
Slovenian: Poleg tega so v vsaki od predloženih študij uporabili drugo pasmo ovac.
English: Quality, target animal safety, user safety, environmental risk and parasitic resistance for the concerned veterinary medicinal products have not been assessed in this referral procedure.
Slovenian: Kakovost, varnost za ciljno živalsko vrsto, varnost uporabnikov, tveganje za okolje in odpornost parazitov proti zadevnim zdravilom za veterinarsko uporabo v tem napotitvenem postopku niso bili ocenjeni.
English: Risk management or mitigation measures
Slovenian: Ukrepi za obvladovanje ali zmanjševanje tveganja
English: The two products used in the studies include almost the same excipients, but in different quantities.
Slovenian: Obe zdravili, uporabljeni v študijah, vsebujeta skoraj enake pomožne snovi, vendar v različnih količinah.
English: The differences between the two residues studies have been considered.
Slovenian: Obravnavana je bila razlika med obema študijama izločanja ostankov.
English: One of these products (‘Flukiver 5%') was used in the pivotal residues study, Study 1.
Slovenian: Eno od teh zdravil (Flukiver 5 %) so uporabili v ključni študiji ostankov, študiji 1.
English: Residues depletion data were submitted by two of the affected marketing authorisation holders.
Slovenian: Podatke o izločanju ostankov sta predložila dva zadevna imetnika dovoljenja za promet z zdravilom.
English: To ensure the safety of consumers of food and food products derived from animals treated with products containing closantel, the European Commission has set MRLs for closantel in the edible tissues of sheep.
Slovenian: Da bi zagotovili varnost potrošnikov živil in prehrambnih izdelkov, proizvedenih iz živali, zdravljenih z zdravili, ki vsebujejo klozantel, je Evropska komisija določila MRL za klozantel v tkivih ovac, namenjenih prehrani.
English: In order for closantel-derived residues to deplete below the MRLs, a sufficient time between treatment and slaughter must be allowed.
Slovenian: Da bi se lahko koncentracija ostankov klozantela znižala pod MRL, mora med zdravljenjem in zakolom miniti zadosten čas.
English: The main non-aqueous vehicle, propylene glycol, is present in both products in different quantities.
Slovenian: Glavni nevodni vehikel, propilenglikol, je v obeh zdravilih prisoten v različnih količinah.
English: It cannot be concluded from the data available whether these breed differences had any influence on the depletion patterns seen.
Slovenian: Iz razpoložljivih podatkov ni mogoče sklepati, ali so te razlike med pasmami kakorkoli vplivale na opažene vzorce izločanja.
English: It is slowly released from plasma and very slowly metabolised, and is therefore retained in the circulation for a long time; the plasma elimination half-life in sheep is 22.7 days.
Slovenian: Iz plazme se sprošča počasi in se zelo počasi presnavlja, zato dolgo ostane v obtoku; pri ovcah znaša razpolovni čas izločanja iz plazme 22,7 dneva.
English: While the efficacy of the concerned products in sheep has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and prevention of infestations with named parasites.
Slovenian: Čeprav učinkovitost zadevnih zdravil pri ovcah v okviru napotitve ni bila natančno ovrednotena, se šteje, da so ocenjevana zdravila učinkovita pri zdravljenju in obvladovanju infestacije z navedenimi paraziti.
English: The first timepoint where all residues are below the authorised MRL is at 89 days, and, with the addition of a safety span of 20% to take into account the variability of depletion between the animals used, a withdrawal period of 107 days is calculated.
Slovenian: Prva časovna točka, v kateri so vsi ostanki pod dovoljeno MRL, je 89 dni in ob dodatku 20-odstotnega varnostnega razpona za upoštevanje razlik v izločanju med uporabljenimi živalmi znaša izračunana karenca 107 dni;
English: The reference product is Flukiver 50 mg/ml Solution for Injection, which has been authorised in various Member States since 1989.
Slovenian: Referenčno zdravilo je zdravilo Flukiver 50 mg/ml raztopina za injiciranje, ki je bilo od leta 1989 odobreno v različnih državah članicah.
English: Both marketing authorisation holders provided reports detailing the validation of the analytical method used, and the performance characteristics were mostly described in accordance with current standards.
Slovenian: Oba imetnika dovoljenja za promet z zdravilom sta predložila poročilo, v katerem sta opisala uporabljeno analizno tehniko, zmogljivostne karakteristike pa so bile večinoma opisane v skladu z veljavnimi standardi.
English: Most (90%) of a dose of closantel is excreted unchanged in the bile/faeces after intramuscular administration, but only 10% within 48 hours, after which the rate slows further so that 1 - 2% of the dose is eliminated each day.
Slovenian: Večina (90 %) odmerka klozantela se po intramuskularnem dajanju izloči nespremenjenega z žolčem/blatom, vendar le 10 % v 48 urah, nato pa se hitrost izločanja nadalje zmanjša, tako da se vsak dan izloči od 1 do 2 % odmerka.
English: The last product is formulated with a large percentage of glycerol formal.
Slovenian: To zdravilo je bilo formulirano z velikim deležem glicerol formala.
English: This mitigation measure was thoroughly evaluated and discussed by the CVMP, and determined to be unnecessary.
Slovenian: Odbor CVMP je ta ublažitveni ukrep celovito ocenil in obravnaval ter sklenil, da ni potreben.
English: Closantel is a salicylanilide anthelmintic, a synthetic antiparasitic agent with efficacy against liver fluke, haematophagous nematodes and larval stages of some arthropods in sheep and cattle.
Slovenian: Klozantel je salicilanilidni antihelmintik, sintetična protiparazitska snov, ki učinkuje proti jetrnemu metljaju, hematofagnim nematodom in larvalnim fazam nekaterih členonožcev pri govedu in ovcah.
English: Two of the product formulations are very similar, being solutions with similar excipients, and using a similar proportion of water and propylene glycol as the vehicle.
Slovenian: Dve od formulacij sta si zelo podobni, in sicer gre za raztopini s podobnimi pomožnimi snovmi ter podobnim deležem vode in propilenglikola kot vehiklom.
English: This is considered to be an important parameter affecting the residues at the injection site.
Slovenian: To se je štelo za pomemben parameter, ki vpliva na koncentracijo ostankov na mestu injiciranja.
English: The residue depletion data for the marker tissue, liver, do not allow for a statistical determination of a withdrawal period (the assumption of normal distribution of the errors was not met).
Slovenian: Podatki o izločanju ostankov za ciljno tkivo, tj. jetra, ne omogočajo statistične določitve karence (predpostavka o normalni porazdelitvi napak ni bila izpolnjena).
English: The specified pH of the products used in studies 1 and 2 were in the same range; the effect of pH to explain any differences can thus be ruled out.
Slovenian: Določeni pH zdravil, uporabljenih v študijah 1 in 2, je bil v istem razponu; z vplivom pH torej ni mogoče razložiti razlik.
English: All edible tissues, including injection sites, were sampled on days 19, 40, 61, 89, and 103 after treatment and analysed using an SPE-LC-MS/MS method of analysis, validated in line with current requirements.
Slovenian: Vsa tkiva, namenjena prehrani, vključno z mesti injiciranja, so vzorčili 19., 40., 61., 89. in 103. dan po zdravljenju in analizirali z analizno metodo SPE-LC MS/MS, validirano v skladu z veljavnimi zahtevami.
English: The recommended doses are 2.5 mg or 5 mg closantel per kg body weight (bw) for cattle and sheep, depending on the parasitic species and/or parasitic life stage at the time of treatment.
Slovenian: Priporočena odmerka sta 2,5 mg in 5 mg klozantela na kilogram telesne mase pri govedu in ovcah, odvisno od parazitske vrste in/ali parazitske življenjske faze v času zdravljenja.
English: Both studies administered a dose of 5 mg/kg body weight; however, due to differences in the weights of the animals used in the two studies, the volume of product administered was different (6.7 - 8.4 ml administered in Study 1; 3.6 - 5.8 ml administered in Study 2).
Slovenian: Pri obeh študijah so uporabili odmerek 5 mg/kg telesne mase; vendar pa se je zaradi razlike v masah živali, uporabljenih pri obeh študijah, volumen danega zdravila razlikoval (6,7-8,4 ml, injiciran v študiji 1; 3,6-5,8 ml, injiciran v študiji 2).
English: Another product has propylene glycol as the main vehicle, and includes no water for injections.
Slovenian: Eno od zdravil ima propilenglikol kot glavni vehikel in ne vsebuje vode za injiciranje.
English: Consideration has been given to the absolute amounts injected at the subcutaneous injection site.
Slovenian: Obravnavana so bile tudi absolutne količine, injicirane na mestu subkutanega injiciranja.
English: An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e., a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product Santiola, containing 50 mg closantel per ml, with Ireland as Reference Member State (IE/V/0377/001/DC).
Slovenian: V skladu s členom 13(1) Direktive 2001/82/ES je bila predložena vloga, tj. generična vloga za izdajo dovoljenja za promet v skladu z decentraliziranim postopkom za veterinarsko zdravilo Santiola, ki vsebuje 50 mg klozantela na ml, z Irsko kot referenčno državo članico (IE/V/0377/001/DC).
English: The first study used Merino crosses, which are bred for meat production, whereas the second study used Ripollesa, which are bred for both meat and milk production.
Slovenian: V prvi študiji so uporabili križance s pasmo merino, ki jih vzrejajo za proizvodnjo mesa, v drugi študiji pa so uporabili pasmo Ripollesa, ki jo vzrejajo za proizvodnjo mesa in mleka.
English: When administered parenterally, closantel is absorbed relatively quickly into the systemic circulation (Tmax = 8 - 24 h) and is highly bound to albumin in the plasma.
Slovenian: Ob parenteralnem dajanju se klozantel razmeroma hitro absorbira v sistemski obtok (Tmax = 8-24 h) in se močno veže na albumin v plazmi.
English: The proposed sheep meat withdrawal period for the generic product, Santiola, was 77 days, in line with the Irish reference product (although the target species ‘sheep' was removed from the reference product during the application procedure for Santiola), but not in accordance with the data provided by France during the procedure.
Slovenian: Predlagana karenca za ovčje meso je bila pri generičnem zdravilu, zdravilu Santiola, 77 dni, kar je skladno z irskim referenčnim zdravilom (čeprav je bila ciljna vrsta „ovce“ med postopkom obravnave vloge za zdravilo Santiola odstranjena), ni pa skladno z referenčnimi podatki, ki jih je med postopkom predložila Francija.
English: However, considering the results of this pilot study, and the limited information that they provide, this conclusion might not be adequate, as the residue concentrations in the sampled tissues did not fall below the respective MRLs; therefore, it was not possible to know which would be the withdrawal period determining tissue from these data.
Slovenian: Rezultati te pilotske študije in omejene informacije, ki so jih predložili, pa za ta sklep morda ne zadoščajo, saj koncentracije ostankov v vzorčenih tkivih niso padle pod ustrezne MRL; zato iz teh podatkov ni bilo mogoče sklepati na to, kako dolga naj bo karenca.
English: Considering the relative proportions of these excipients, there was no reason to expect the viscosity of the product containing glycerol formal would be greater than that of some of the other products included in this referral.
Slovenian: Ob upoštevanju relativnih deležev teh pomožnih snovi ni bilo razloga, da bi pričakovali, da bo viskoznost zdravila, ki vsebuje glicerol formal, večja od viskoznosti nekaterih drugih zdravil, vključenih v to napotitev.
English: The study was conducted in 2016 with 20 treated animals (five mixed-sex groups of four animals) and a control group consisting of two untreated animals.
Slovenian: Študijo so opravili leta 2016 pri 20 zdravljenih živalih (pet skupin štirih živali mešanih spolov) in eni kontrolni skupini, ki je vključevala dve nezdravljeni živali.
English: The study was conducted in 2009, with 30 treated animals (5 mixed-sex groups of six animals) and a control group consisting of one untreated animal.
Slovenian: -Študijo so opravili leta 2009 pri 30 zdravljenih živalih (pet skupin šestih živali mešanih spolov) in kontrolni skupini, ki je vključevala eno nezdravljeno žival.
English: Therefore, the Committee considered that the proposed WP of 107 days derived from Study 1 can be extrapolated to all concerned products.
Slovenian: Odbor je zato ocenil, da se lahko predlagana karenca 107 dni, izpeljana iz študije 1, uporabi pri vseh zdravilih iz napotitve.
English: • from the data provided, it is concluded that the full residues depletion study provided for ‘Flukiver 5%' (Study 1) could be considered as the pivotal study, as it was well-reported, and conformed well to current requirements.
Slovenian: • na podlagi predloženih podatkov je mogoče zaključiti, da se celotna študija izločanja ostankov, predložena za zdravilo Flukiver 5 % (študija 1), lahko šteje za ključno študijo, saj je bilo poročanje dovolj natančno in je bila skladna tudi z veljavnimi zahtevami.
English: However, there are some significant differences between this and the other product formulations that are in the scope of this referral procedure.
Slovenian: Vendar pa so med to formulacijo in drugimi formulacijami zdravil, vključenih v ta napotitveni postopek, nekatere pomembne razlike.
English: • with regard to the need for a maximum injection volume to be recommended in case of any difference in depletion on injection site residues, the CVMP does not consider it necessary to restrict the use of these products in this way.
Slovenian: • kar zadeva predlog, da bi v primeru morebitnih razlik v izločanju ostankov z mesta injiciranja priporočili največji volumen injiciranja, odbor CVMP meni, da ni potrebno, da bi uporabo teh zdravil omejevali na tak način;
English: The CVMP considered whether it would be necessary to restrict the volume of injection, to mitigate any uncertainties around the effect of formulation differences at the injection sites.
Slovenian: Odbor CVMP je presojal, ali bi bilo treba omejiti injicirani volumen, da bi ublažili morebitne negotovosti glede učinka razlik v formulaciji na mestih injiciranja.
English: The UK therefore considered that it is necessary to refer the matter to the CVMP in the interests of protecting consumer safety in the Union and requested the Committee to review all available residue depletion data and recommend withdrawal periods for sheep (meat and offal).
Slovenian: Združeno kraljestvo je zato menilo, da je treba zadevo zaradi varstva potrošnikov v Uniji napotiti na Odbor za zdravila za uporabo v veterinarski medicini (CVMP), in zahtevalo, da Odbor pregleda vse razpoložljive podatke o izločanju ostankov in priporoči obdobja karence za ovce (meso in organe).
English: The product used in Study 2 ‘Endoex Solucion Injectable', has a level of propylene glycol that is not comparable to the product used in Study 1.
Slovenian: Zdravilo Endoex Solucion Injectable, uporabljeno v študiji 2, ima visoko raven propilenglikola, ki ni primerljiva z ravnijo propilenglikola v zdravilu, uporabljenem v študiji 1.
English: Two residues depletion studies were provided by the MAHs involved in the procedure, which were not comparable in terms of the reliability of the data, study design and reporting, and subsequently their outcomes.
Slovenian: Imetniki dovoljenja za promet z zdravilom, udeleženi v postopku, so predložili dve študiji izločanja ostankov, ki ju z vidika zanesljivosti podatkov, zasnove študije in poročanja ter posledično njunih izidov ni bilo mogoče primerjati.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in imetnikov dovoljenj za promet z zdravilom v državah članicah
English: Data were provided on the physicochemical properties of the different solvents used in these product formulations, particularly regarding their relative viscosities, and how this would affect absorption from the injection site.
Slovenian: Predloženi so bili podatki o fizikalno-kemičnih lastnostih različnih vehiklov, ki se uporabljajo pri teh formulacijah zdravil, zlasti o njihovi relativni viskoznosti, in podatki o tem, kako bi to vplivalo na absorpcijo z mesta injiciranja.
English: The viscosity of propylene glycol is greater than that of glycerol formal which is greater than the viscosity of water.
Slovenian: Viskoznost propilenglikola je večja od viskoznosti glicerol formala, ta pa je večja od viskoznosti vode.
English: The female sheep were not lactating during the conduct of the study.
Slovenian: Samice ovac med izvedbo študije niso bile v obdobju laktacije.
English: The analysis of the sheep tissues differed between the two studies, with study 1 using LC-MS/MS as their analytical method, and study two using HPLC-FD.
Slovenian: Analiza tkiva ovac se je med študijama razlikovala, pri čemer so v študiji 1 kot analizno metodo uporabili LC MS/MS, v študiji 2 pa so uporabili HPLC-FD.
English: However, it is not considered that the conduct of the two studies was sufficiently similar to allow this comparison, and therefore to conclude on the impact that formulation may have had on injection site depletion.
Slovenian: Vendar se ni štelo, da sta bili obe študiji izvedeni dovolj podobno, da bi bila takšna primerjava sprejemljiva in da bi zato lahko zaključili, da je na izločanje z mesta injiciranja vplivala formulacija zdravila.
English: As data were collected for injection sites, only, in Study 2, it could have been possible to combine or compare data from studies 1 and 2 for depletion from this tissue, only.
Slovenian: Ker so bili podatki v študiji 2 pridobljeni samo za mesta injiciranja, bi bilo mogoče združiti ali primerjati samo podatke iz študij 1 in 2 za to tkivo.
English: An additional risk mitigation measure of restricting the maximum injection volumes was considered by the CVMP, but ultimately it was decided that this was not required to ensure consumer safety.
Slovenian: Odbor CVMP je obravnaval uporabo dodatnega blažilnega ukrepa, tj. omejitve največjega injiciranega volumna, vendar je na koncu presodil, da ta za zagotovitev varnosti potrošnikov ni potreben.
English: The limit of detection for muscle was also lower in Study 1 (<2 µg/kg) than in Study 2 (492 µg/kg).
Slovenian: V študiji 1 (< 2 µg/kg) je bila meja določljivosti v mišičju nižja kot v študiji 2 (492 µg/kg).
English: • on the basis of the available data, the CVMP considered the withdrawal periods for meat and offal derived from treated sheep should be amended to provide assurance for consumer safety;
Slovenian: • na podlagi razpoložljivih podatkov je odbor CVMP menil, da je treba obdobja karence za meso in organe, pridobljene iz zdravljenih ovac, spremeniti zaradi zagotavljanja varnosti potrošnikov;
English: In addition, the data provided by Study 2 was not considered to be suitable to set withdrawal periods, even for the product used in that study, since residues depletion was investigated at the injection site only.
Slovenian: Poleg tega se podatki, predloženi iz študije 2, niso šteli za primerne za določitev obdobja karence niti za zdravilo, ki je bilo uporabljeno v študiji, saj so izločanje ostankov proučevali samo na mestu injiciranja;
English: Thus, it is considered that the rate of absorption from the injection site, which is measured in hours/days, will have a negligible influence on the rate of elimination from the edible tissues, which is measured in weeks.
Slovenian: Zato se ocenjuje, da bo hitrost absorpcije z mesta injiciranja, ki se meri v urah/dnevih, zanemarljivo vplivala na hitrost izločanja iz tkiv, namenjenih prehrani, ki se meri v tednih.
English: The concentrations of closantel residues were below the respective maximum residue limits (MRLs) at 19 days after administration in kidney, 40 days in muscle and fat, and 89 days in liver.
Slovenian: Koncentracije ostankov klozantela so bile nižje od ustreznih najvišjih mejnih vrednosti ostankov (MRLmaximum residue limits): v ledvicah 19 dni po dajanju, v mišičju in maščevju 40 dni po dajanju in v jetrih 89 dni po dajanju.
English: Formulation differences may make a difference to how the active substance is absorbed from the injection site, and also, therefore, the overall residues depletion pattern.
Slovenian: Razlike v formulacijah lahko povzročijo razlike pri tem, kako se učinkovina absorbira z mesta injiciranja, in s tem tudi na splošni vzorec izločanja ostankov.
English: The Committee considered that, due to the slow and limited metabolism of closantel, the high protein binding and retention in plasma, and the long elimination time from tissues, the differences seen in the product formulations, which may lead to different rates of absorption from the injection site, should not influence the final rate of elimination from the edible tissues, other than at the injection site itself.
Slovenian: Odbor je ocenil, da zaradi počasne in omejene presnove klozantela, visoke stopnje vezave in zadrževanja beljakovin v plazmi ter dolgega obdobja izločanja iz tkiv razlike v formulacijah zdravil, ki bi lahko privedle do različnih hitrosti absorpcije z mesta injiciranja, ne bi smele vplivati na končno hitrost izločanja iz tkiv, namenjenih prehrani, razen s samega mesta injiciranja.
English: In the GLP study, the injection sites were sampled on days 2, 7, 14, 24 and 29 days after treatment and analysed using an HPLC-FD method of analysis, validated in line with current requirements.
Slovenian: V študiji, skladni z dobro laboratorijsko prakso, so mesta injiciranja vzorčili 2., 7., 14., 24. in 29. dan po zdravljenju ter analizirali z analizno metodo, validirano v skladu z veljavnimi zahtevami.
English: Having considered the grounds for referral and the data available, the CVMP concluded that the withdrawal periods for meat and offal derived from treated sheep should be amended to 107 days to provide assurance for consumer safety.
Slovenian: Po proučitvi razlogov za napotitev in razpoložljivih podatkov je odbor CVMP zaključil, da je treba zaradi zagotovitve varnosti potrošnikov obdobja karence za meso in organe, pridobljene iz zdravljenih ovac, spremeniti na 107 dni, da se zagotovi varnost potrošnikov.
English: • as data have been provided that demonstrate that the impact of the formulation on the rate of absorption from the injection site is of minor significance compared to the very slow rate of elimination from the other edible tissues, the withdrawal period of 107 days derived in Study 1 can be extrapolated to all concerned products.
Slovenian: • ker so bili predloženi podatki, ki kažejo, da je vpliv formulacije na hitrost absorpcije z mesta injiciranja manjšega pomena glede na izjemno počasnost izločanja iz drugih tkiv, namenjenih prehrani, je karenco 107 dni, izračunano v študiji 1, mogoče ekstrapolirati na vsa zadevna zdravila;