FrancophonIA/ELRC3.0 huggingface dataset:
English: The United Kingdom expressed concerns that the difference in withdrawal periods established across the European Union for the relevant products may present a potential serious risk to human health, and requested the Committee for Medicinal Products for Veterinary Use (CVMP) to give its opinion on the matter.
Slovenian: Združeno kraljestvo je izrazilo zadržek, da lahko razlike v karencah, ki veljajo v Evropski uniji za zadevna zdravila, predstavljajo potencialno resno tveganje za človeško zdravje, zato je zaprosilo Odbor za zdravila za uporabo v veterinarski medicini (CVMP), naj poda svoje mnenje glede omenjene zadeve.
English: From table 1 above, it is clear that for group 1, for which a number of studies was available, the range of calculated withdrawal periods varied considerably (from 21 to >49 days).
Slovenian: Iz preglednice 1 zgoraj je razvidno, da je za skupino 1, za katero je bilo na voljo več študij, razpon izračunanih karenc precej variiral (od 21 do >49 dni).
English: The studies were well-conducted and comprised a considerable number of slaughter time points.
Slovenian: Študije so bile dobro izvedene in so zajele precej časovnih točk.
English: PASTEUR - Filiala Filipeşti Str. Principală, nr. 944, Filipeştii de Pădure,
Slovenian: Romunija PASTEUR - Filiala Filipeşti Str. Principală, nr. 944, Filipeştii de Pădure, Jud.
English: Ivermectin is currently included in Annex I of Council Regulation (EEC) No 2377/90 with MRLs for all food producing species as follows:
Slovenian: Ivermektin je trenutno vključen v Dodatku I Uredbe Sveta (EGS) št. 2377/90, v katerem so določene MRL za vse živalske vrste za proizvodnjo živil, in sicer:
English: Ivermectin is a broad spectrum endectocide of the avermectin family.
Slovenian: Ivermektin je endektocid širokega spektra iz družine avermektinov.
English: Number of acceptable residue depletion studies
Slovenian: Število zdravil Število sprejemljivih študij o izločanju ostankov
English: No suitable data No suitable data No suitable data
Slovenian: Ni primernih podatkov Ni primernih podatkov Ni primernih podatkov
English: Formulation groups allocated for the 293 products that are the subject of this referral.
Slovenian: Formulacijske skupine za 293 zdravil, ki so vključena v ta napotitveni postopek.
English: Each group contained products considered to be essentially the same, in formulation terms.
Slovenian: Vsaka skupina je vsebovala zdravila, ki v okviru formulacije veljajo za bistveno enaka.
English: Based on these MRLs, the daily intake of total residues will represent about 15% of the ADI.
Slovenian: Na podlagi teh MRL bo dnevni vnos skupnih ostankov obsegal približno 15 % ADI.
English: 1 CVMP Note for guidance:
Slovenian: 1 Navodila CVMP:
English: These observations support the view that in the studies provided to the CVMP, sources of variation were present that were more important than formulation effects.
Slovenian: Takšna opažanja podpirajo mnenje, da so bili v študijah, predloženih CVMP, prisotni viri variacije, ki so pomembnejši od učinkov formulacije.
English: To address this question quality experts examined the qualitative and quantitative composition of all the 293 ivermectin containing products that are the subject of this referral, grouping products that can be considered to be the same or essentially the same.
Slovenian: Da bi odgovorili na to vprašanje, so strokovnjaki za kakovost pregledali kakovostno in količinsko sestavo vseh 293 zdravil, ki vsebujejo ivermektin in so vključena v ta napotitveni postopek, ter združili zdravila, ki jih lahko štejemo za enaka ali bistveno enaka.
English: Slovak Republic CEVA Animal Health Slovakia, spol.
Slovenian: CEVA Animal Health Slovakia, spol.
English: It was noted that some of the studies were identical but were submitted by different MAHs.
Slovenian: Ugotovili so, da so nekatere študije identične, vendar so jih predložili različni imetniki dovoljenj za promet z zdravilom.
English: It was not possible to use the statistical method for the analysis of these pooled data because a number of relevant statistical assumptions were not met.
Slovenian: Statistične metode za analizo teh združenih podatkov ni bilo mogoče uporabiti, ker ni bilo izpolnjenih več pomembnih statističnih predpostavk.
English: Ivermectin was previously evaluated by the CVMP in order to establish maximum residue limits (MRLs).
Slovenian: CVMP je ivermektin že ovrednotil, da bi določil najvišje mejne vrednosti zaostankov zdravila (MRL).
English: EMEA website publication,
Slovenian: Objavljeno na spletišču EMEA,
English: Veterina Polska Sp. Zo.o.
Slovenian: Madžarska Veterina Polska Sp. Zo.o.
English: Individual withdrawal periods (days) derived from the ivermectin residue studies
Slovenian: Posamezne karence (v dneh), izpeljane iz študij ostankov ivermektina
English: Marketing Authorisations for injectable veterinary medicinal products containing ivermectin for use in cattle have been granted in all Member States of the European Union via different authorisation procedures (mutual recognition procedures and national procedures) and under various legal bases (full, generic, bibliographic, informed consent).
Slovenian: Dovoljenja za promet z zdravili za injiciranje, ki vsebujejo ivermektin, za uporabo pri govedu so bila odobrena v vseh državah članicah Evropske unije po različnih postopkih odobritve (postopki medsebojnega priznavanja in nacionalni postopki) ter na različnih pravnih podlagah (popolna, generična, bibliografska, privoljenje po pojasnilu).
English: VETERINA Plus d.o.o.,Dunajska 1000 Ljubljana,
Slovenian: Slovenija VETERINA Plus d.o.o.,Dunajska 51, 1000 Ljubljana,
English: Overall, from the data examined, the presence of a formulation effect can neither be confirmed nor refuted.
Slovenian: Na splošno na podlagi pregledanih podatkov ni možno potrditi ali zavreči prisotnosti učinka formulacije.
English: INTERVET ROMANIA S.R.L.
Slovenian: Romunija INTERVET ROMANIA S.R.L.
English: The table below lists the 13 formulation groups along with the number of products in each group, the number of available studies for each group, and the individual withdrawal periods calculated for the various products for which adequate data were made available.
Slovenian: V spodnji preglednici je navedeno teh 13 formulacijskih skupin s številom zdravil v vsaki skupini, številom razpoložljivih študij za vsako skupino in posameznimi karencami, izračunanimi za različna zdravila, za katera so bili dostopni primerno kakovostni podatki.
English: On the other hand, there is no scientific rationale to explain why withdrawal periods for formulations that are the same or essentially the same, should be different.
Slovenian: Po drugi strani pa ni znanstvene razlage za razlike med karencami za formulacije, ki so enake ali bistveno enake.
English: All products containing ivermectin and clorsulon had similar formulations and a number of residue depletion studies were submitted for the clorsulon component of products in this group.
Slovenian: Vsa zdravila, ki vsebujejo ivermektin in klorsulon, so imela podobne formulacije in v tej skupini je bilo predloženih več študij izločanja ostankov za klorsulonsko komponento.
English: 3., 1093 Budapest Hungary
Slovenian: 3., 1093 Budapest
English: Merial Italia S.p.A. a Socio Unico, Via Vittor Pisani, 16
Slovenian: a Socio Unico, Via Vittor Pisani, 16
English: Av. Párroco Pablo Diez, 49 - 57 24010 - Leon
Slovenian: Romunija SYVA Av. Párroco Pablo Diez, 49 - 57 24010 - Leon
English: LIST OF THE NAMES, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: SEZNAM IMEN, JAKOSTI ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, NAČINOV UPORABE ZDRAVILA, PRIPOROČENIH ODMERKOV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: The high level of variation in residue concentrations and depletion profiles seen both within and between formulation groups could easily have masked a formulation effect.
Slovenian: Visoka raven variacije koncentracij ostankov ter profilov izločanja, ki je opazna znotraj formulacijskih skupin in med njimi, lahko enostavno zakrije učinek formulacije.
English: The procedure involved 293 authorised injectable veterinary medicinal products containing ivermectin (see Annex I).
Slovenian: Postopek je vključeval 293 odobrenih veterinarskih zdravil za injiciranje, ki vsebujejo ivermektin (glejte Dodatek I)
English: While the precise sources of variation remain unidentified, it is quite likely that the sampling procedure is one important factor; it is difficult to be sure that the area with the highest residue concentration is accurately sampled, in particular for subcutaneous injections.
Slovenian: Čeprav ostajajo točni viri variacije neznani, je verjetno pomemben faktor postopek vzorčenja; težko je zagotoviti, da se natančno odvzame vzorec iz področja z najvišjo koncentracijo zaostankov, zlasti pri podkožnem injiciranju.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF INJECTABLE VETERINARY MEDICINAL PRODUCTS CONTAINING IVERMECTIN
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA VETERINARSKIH ZDRAVIL ZA INJICIRANJE, KI VSEBUJEJO IVERMEKTIN
English: However, literature data indicate that the formulation can have an impact on the absorption rate of avermectins from the injection sites.
Slovenian: Vendar podatki iz literature kažejo, da lahko formulacija vpliva na hitrost absorpcije avermektinov z mest injiciranja.
English: BIOWET GORZOW PHARMACEUTICALS COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK
Slovenian: Romunija BIOWET GORZOW PHARMACEUTICALS COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK
English: Şoseaua de Centură, nr. 27-28, 077040 Chiajna, Ilfov Romania
Slovenian: Şoseaua de Centură, nr. 27-28, 077040 Chiajna, Ilfov
English: The Committee considered that based on the totality of the data, and based on the fact that at and beyond day 49 the intake calculation remains above the ADI for only two animals, a withdrawal period of 49 days would provide a degree of safety comparable to that provided using the statistical approach (and a withdrawal period based on the 95% tolerance limit).
Slovenian: Odbor je menil, da bi na podlagi celotnega nabora podatkov in dejstva, da na 49. dan in po njem izračun vnosa ostane nad ADI le pri dveh živalih, 49-dnevna karenca zagotovila raven varnosti, ki je primerljiva z ravnjo varnosti, izpeljano s statističnim pristopom (in karenco na podlagi 95-odstotne meje tolerance).
English: All mammalian food producing species
Slovenian: Vse vrste sesalcev za proizvodnjo živil
English: Since there is no muscle MRL for ivermectin, the ADI-based approach was used for evaluating the total daily intake of residues that may arise from the consumption of tissues of each animal (EMEA/CVMP/542/03-Final)2.
Slovenian: Ker za ivermektin ni MRL v mišičnem tkivu, so pristop na podlagi ADI uporabili za vrednotenje skupnega dnevnega vnosa zaostankov, ki lahko nastane zaradi uporabe tkiv posamezne živali (EMEA/CVMP/542/03-Final)2.
English: all intake data for ivermectin time (days)
Slovenian: vsi podatki o vnosu za ivermektin čas (v dneh)
English: United Kingdom Alstoe Ltd Sheriff Hutton Industrial Park Sheriff Hutton
Slovenian: Sheriff Hutton Industrial Park Sheriff Hutton
English: Wherever possible the CVMP used the statistical method for calculating the individual withdrawal periods based on single studies, but in line with the CVMP Note for Guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1, where the necessary parameters were not shown to be valid for the statistical analysis, the alternative approach was used for calculating withdrawal periods.
Slovenian: Kjer je bilo mogoče, je CVMP uporabil statistično metodo za izračun posameznih karenc na podlagi posameznih študij, vendar v skladu z Navodili CVMP: pristop k usklajevanju karenc (EMEA/CVMP/036/95)1; kjer se za potrebne parametre ni dokazala veljavnost za statistično analizo, so za izračun karenc uporabili alternativni pristop.
English: 040185 Bucureşti Romania
Slovenian: 040185 Bucureşti
English: Marketing Authorisation Holder and address
Slovenian: Imetnik dovoljenja za promet z zdravilom in naslov
English: FARMAVET S.A. Str. Petricani 198, Chişinău
Slovenian: Str. Petricani 198, Chişinău
English: On a log-scale, the total ivermectin residue intake (µg) for a consumer, calculated from data of each animal (data points), compared with the ADI (µg/person, horizontal line).
Slovenian: Logaritemska vrednost skupnega vnosa zaostankov ivermektina (µg) za potrošnika, izračunana iz podatkov za vsako žival (podatkovne točke), v primerjavi z ADI (µg/osebo, vodoravna črta).
English: In these studies, different formulations showed different absorption patterns of avermectins (including ivermectin), while all other parameters were the same (such as species, breed, weight, and place of injection).
Slovenian: V teh študijah so različne formulacije pokazale različne vzorce absorpcije avermektinov (vključno z ivermektinom), medtem ko so bili drugi parametri enaki (kot so živalska vrsta, pasma, telesna masa in mesto injiciranja).
English: From the data available no correlations were found that could explain the difference in depletion profiles or estimated withdrawal periods, and none of the parameters recorded could be identified as a large single source of variation.
Slovenian: V razpoložljivih podatkih niso našli korelacij, ki bi lahko pojasnile razlike v profilih izločanja ali ocenjenih karencah, hkrati pa se noben ugotovljen parameter ni pokazal kot velik in edini vir variacije.
English: From the overall data submitted by the MAHs and the National Competent Authorities of the Member States only 11 ivermectin residue depletion studies were considered of adequate quality for the purpose of calculating withdrawal periods, as only in these studies the relevant tissues including the injection sites were sampled and analysed.
Slovenian: Od vseh podatkov, ki so jih imetniki dovoljenj za promet z zdravilom predložili nacionalnim pristojnim organom držav članic, je le 11 študij o izločanju ostankov ivermektina bilo primerno kakovostnih za izračun karenc, ker so v teh študijah vzeli vzorce primernih tkiv, vključno z mesti injiciranja, ter jih analizirali.
English: Considering the totality of the data on clorsulon residue depletion, the statistical method could not be used for calculating the withdrawal periods as the relevant statistical assumptions were not met.
Slovenian: Če upoštevamo celoten nabor podatkov o izločanju zaostankov klorsulona, ni možno uporabiti statistične metode za izračun karenc, saj niso izpolnjene ustrezne statistične predpostavke.
English: Czech Republic Bioveta a.s., Komenského 212
Slovenian: Romunija Bioveta a.s., Komenského 212
English: 83 102 BRATISLAVA
Slovenian: 83 102 BRATISLAVA Slovak Republic
English: Using the alternative approach and applying safety span of 10% a withdrawal period of 66 days was derived.
Slovenian: Z alternativnim pristopom in uporabo varnostnega faktorja 10 % so izpeljali karenco 66 dni.
English: Divasa Farmavic Hungaria Ltd. H-6070 Izsák, Kossuth L. u. 60.
Slovenian: Madžarska Divasa Farmavic Hungaria Ltd. H-6070 Izsák, Kossuth L. u. 60.
English: As a matter of principle with regards to products that have been shown to be bioequivalent, it should be noted that the definition of bioequivalence does not guarantee equal levels of residues at the injection site far beyond the time points where plasma samples were taken.
Slovenian: Upoštevati je treba, da načelno pri zdravilih z dokazano bioekvivalenco definicija bioekvivalence ne zagotavlja enakih ravni zaostankov na mestu injiciranja na časovnih točkah dolgo po odvzemu vzorcev plazme.
English: • the CVMP assessed the original data provided during this referral and concluded that, based on these data, an impact of formulation on residue depletion could not be demonstrated and that the variability in the data was such that an effect of formulation on residue depletion could have been masked;
Slovenian: • CVMP je ovrednotil izvirne podatke, ki so bili predloženi v tem napotitvenem postopku, ter zaključil, da na podlagi teh podatkov ni možno dokazati vpliva formulacije na izločanje ostankov, ter da je variabilnost podatkov lahko zakrila učinek formulacije na izločanje ostankov;
English: Bremer Pharma GmbH.
Slovenian: Madžarska Bremer Pharma GmbH.
English: While the data examined by the CVMP did lead to the calculation of different withdrawal periods for products that are essentially the same, this variability is not considered to reflect product specific effects but is rather a feature of the way the products were used (i.e. the variation results from differences such as animal bodyweight, breed, sex, age, injection volume and sampling procedure).
Slovenian: Čeprav so podatki, ki jih je pregledal CVMP, dali izračune različnih karenc za zdravila, ki so bistveno enaka, velja, da ta variabilnost ne odraža za zdravilo specifičnih učinkov, ampak je posledica načina uporabe zdravil (tj. variacija je posledica razlik v telesni masi živali, pasmi, spolu, starosti, injiciranem volumnu in postopku vzorčenja).
English: Residue depletion data submitted for the formulation group containing ivermectin and closantel led to a withdrawal period of 36 days for closantel, calculated using the alternative approach and applying a safety span of 30%.
Slovenian: Iz podatkov o izločanju ostankov, predloženih za formulacijsko skupino z ivermektinom in klosantelom, so za klosantel z alternativnim pristopom in uporabo varnostnega faktorja 30 % izračunali karenco 36 dni.
English: The variability in calculated withdrawal periods reflects the variability in the depletion profiles and particularly the variability in depletion of residues from the injection site.
Slovenian: Variabilnost izračunanih karenc odraža variabilnost profilov izločanja in zlasti variabilnost izločanja zaostankov z mesta injiciranja.
English: • the CVMP considered that sources of variation linked to the subcutaneous use of ivermectin in cattle are present that lead to different depletion profiles in residue studies, and this variation is of much more importance than any variation that may be caused by formulation differences.
Slovenian: • CVMP je upošteval, da so prisotni viri variacij, povezani s podkožno uporabo ivermektina pri govedu, ki povzročajo različne profile izločanja v študijah ostankov, ter da je ta variacija veliko pomembnejša od vseh variacij, ki so morda posledica razlik v formulacijah.
English: 27540 Bremerhaven
Slovenian: 27540 Bremerhaven Germany
English: In cattle injectable veterinary medicinal products containing ivermectin, either as a single active ingredient or in combination with a second active substance, are used against infestations with endoparasites and ectoparasites by administering 200 μg ivermectin/kg bw subcutaneously.
Slovenian: Pri govedu se zdravila za injiciranje, ki vsebujejo ivermektin kot edino zdravilno učinkovino ali v kombinaciji z drugo, uporabljajo za infestacije z endoparaziti in ektoparaziti z dajanjem subkutano 200 μg ivermektina/kg TM.
English: A key question raised by this referral asks whether there is a formulation effect on residue depletion from tissues and particularly from the injection site.
Slovenian: Ključno vprašanje, zastavljeno v tem napotitvenem postopku, je, ali obstaja učinek formulacije na izločanje ostankov iz tkiv, zlasti iz mesta injiciranja.
English: Taking residue data from the studies into consideration, the first time point at which no values exceeded the MRL for clorsulon was 60 days.
Slovenian: Če upoštevamo podatke o izločanju ostankov iz študij, je 60 dni prva točka, pri kateri vrednosti ne presežejo ravni MRL za klorsulon.
English: For the purposes of this referral, that means that the withdrawal periods for all products in a single formulation group should be the same.
Slovenian: Za namene tega napotitvenega postopka to pomeni, da bi morale biti karence enake za vsa zdravila v posamezni formulacijski skupini.
English: Because the equivalence of local residue levels at the injection site cannot be predicted based on plasma bioequivalence, and because published data indicate that formulation can have an impact on residue depletion profiles for ivermectin, the CVMP considered that, in general, there is no basis for automatically extrapolating a withdrawal period established for one formulation to a second formulation, even if plasma bioequivalence has been shown.
Slovenian: Ker ekvivalence lokalnih ravni zaostankov na mestu injiciranja ni mogoče predvideti na podlagi plazemske bioekvivalence in ker objavljeni podatki kažejo, da ima lahko formulacija vpliv na profile izločanja ostankov ivermektina, je CVMP ugotovil, da na splošno kljub dokazani plazemski bioekvivalenci ni podlage za samodejno ekstrapolacijo karence, ki je ugotovljena pri eni formulaciji, na drugo formulacijo.
English: It should be noted that for many of the studies the scatter of the data was such that the harmonised statistical method for the establishment of withdrawal periods could not be used, and the withdrawal period that results from use of the alternative method is always highly dependent on the choice of time points.
Slovenian: Upoštevati je potrebno, da je bila za večino študij razpršenost podatkov tolikšna, da ni bilo mogoče uporabiti usklajene statistične metode za določitev karence ter da je karenca, ki se izračuna z alternativno metodo, vedno zelo odvisna od izbire časovnih točk.
English: ANTIBIOTICE IASI S.A. Str. Valea Lupului, nr. 1, Iaşi, jud.
Slovenian: Str. Valea Lupului, nr. 1, Iaşi, jud.
English: Additionally, for a further 11 products for which residue depletion data were provided, it was concluded that no individual withdrawal period could be calculated due to the inadequacy of the submitted product-specific data.
Slovenian: Poleg tega je za dodatnih 11 zdravil, za katera so bili predloženi podatki o izločanju ostankov, zaključil, da zaradi nezadostnosti predloženih podatkov, ki so specifični za to zdravilo, posameznih karenc ni mogoče izračunati.
English: When the alternative approach was used for individual residue study data the withdrawal period was derived from the first time point at which all calculated intakes were below the ADI, with the addition of a safety span.
Slovenian: Če se je uporabil alternativni pristop za podatke posameznih študij zaostankov, so karenco izpeljali iz prve časovne točke, v kateri so bili vsi izračunani vnosi pod ADI po dodatku varnostnega faktorja.
English: The CVMP considers that products that are essentially the same (in formulation terms) should have identical withdrawal periods.
Slovenian: CVMP ugotavlja, da bi morala imeti bistveno enaka zdravila (v smislu formulacije) enako karenco.
English: 949 01 Nitra
Slovenian: 949 01 Nitra Slovak Republic
English: In the figure below, all available data for the total intake of ivermectin residues is plotted and compared to the ADI.
Slovenian: Spodnja slika prikazuje vse razpoložljive podatke o skupnem vnosu ostankov ivermektina v primerjavi z ADI.
English: HEMOFARM - HEMOVET Beogradski Put BB Vrsac
Slovenian: Romunija HEMOFARM - HEMOVET Beogradski Put BB
English: Belgium MERIAL Belgium S.A. Bld Sylvain Dupuis 243
Slovenian: Luksemburg MERIAL Belgium S.A. Bld Sylvain Dupuis 243
English: Moreover, because of the fact that the variation in the residue profile due to sources of variation connected to the subcutaneous use of ivermectin is much greater than the formulation effect, the Committee concluded that it would be appropriate to consider the totality of ivermectin residue data from all formulation groups to derive a single harmonised withdrawal period.
Slovenian: Ker je variacija profilov ostankov zaradi virov variacije, ki so povezani s podkožno uporabo ivermektina, veliko večja od učinka formulacije, je Odbor zaključil, da bi bilo primerno upoštevati skupne podatke o ostankih ivermektina iz vseh formulacijskih skupin za izpeljavo enotne usklajene karence.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE LABELLING
Slovenian: DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA OZNAČEVANJA
English: VET4VET d.o.o.
Slovenian: Slovenija VET4VET d.o.o.