FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP considers that products that are essentially the same (in formulation terms) should have identical withdrawal periods.
Danish: CVMP vurderer, at produkter, der er ens i det væsentlige (med hensyn til formulering), bør have samme tilbageholdelsestider.
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.
Danish: I tabellen nedenfor vises de 13 formuleringsgrupper med antallet af produkter i hver gruppe, antallet af tilgængelige undersøgelser for hver gruppe samt individuelle tilbageholdelsestider beregnet for de produkter, hvor tilstrækkelige data var tilgængelige.
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.
Danish: Det var ikke muligt at anvende den statistiske metode til analysen af disse samlede data, fordi en række relevante statistiske forudsætninger ikke blev opfyldt.
English: The numbering of the formulation groups is arbitrary.
Danish: Formuleringsgrupperne er nummereret i vilkårlig rækkefølge.
English: The procedure involved 293 authorised injectable veterinary medicinal products containing ivermectin (see Annex I).
Danish: Proceduren omfattede 293 godkendte injicerbare veterinærlægemidler indeholdende ivermectin (se bilag I).
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.
Danish: Alle produkter indeholdende ivermectin og clorsulon havde ensartede formuleringer, og en række restkoncentrationsundersøgelser blev indgivet for clorsulondelen af produkterne i denne gruppe.
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.
Danish: For at besvare dette spørgsmål undersøgte fremtrædende eksperter den kvalitative og kvantitative sammensætning af alle 293 ivermectinindeholdende produkter, der er genstand for denne procedure, idet produkter, som anses for at være ens eller ens i det væsentlige, blev grupperet.
English: Individual withdrawal periods (days) derived from the ivermectin residue studies
Danish: Individuelle tilbageholdelsestider (dage) udledt af restkoncentrationsundersøgelserne af ivermectin
English: However, literature data indicate that the formulation can have an impact on the absorption rate of avermectins from the injection sites.
Danish: Litteraturdata angiver dog, at formuleringen kan have en indvirkning på absorptionshastigheden for avermectiner fra injektionsstederne.
English: SCHERING PLOUGH SA 65,Ag Dimitriou 17455, Athens Greece
Danish: SCHERING PLOUGH SA 65,Ag Dimitriou 17455, Athen Greece
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.
Danish: Tages der hensyn til restkoncentrationsdata fra undersøgelserne, var det første tidspunkt, hvor ingen værdier oversteg MRL for clorsulon, 60 dage.
English: Based on these MRLs, the daily intake of total residues will represent about 15% of the ADI.
Danish: Baseret på disse MRL-værdier repræsenterer den daglige indtagelse af restkoncentrationer ca. 15 % af ADI-værdien.
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%.
Danish: Restkoncentrationsdata indsendt for formuleringsgruppen indeholdende ivermectin og closantel førte til en tilbageholdelsestid på 36 dage for closantel beregnet ved hjælp af den alternative metode og med anvendelse af en sikkerhedsmargin på 30 %.
English: Ivermectin is a broad spectrum endectocide of the avermectin family.
Danish: Ivermectin er et bredspektret endektocid fra avermectingruppen.
English: The withdrawal period for the product will be the longer of the withdrawal periods derived for the individual components.
Danish: Tilbageholdelsestiden for produktet vil være længere end den udledte tilbageholdelsestid for de enkelte komponenter.
English: MERIAL LABORATORIOS S.A Tarragona, 161-Locales D/E 08014 Barcelona
Danish: Spanien MERIAL LABORATORIOS S.A Tarragona, 161-Locales D/E 08014 Barcelona
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
Danish: BILAG I LISTE OVER VETERINÆRLÆGEMIDLERNES NAVNE, STYRKER, DYREARTER, INDGIVELSESVEJ, ANBEFALET DOSIS OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
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.
Danish: For yderligere 11 produkter, for hvilke restkoncentrationsdata var blevet indgivet, blev det endvidere konkluderet, at der ikke kunne beregnes en individuel tilbageholdelsestid som følge af den utilstrækkelige kvalitet af de indgivne produktspecifikke data.
English: A toxicological Acceptable Daily Intake (ADI) of 10 µg/kg bw/day (600 µg/person per day) was established based on the NOEL of 0.5 mg/kg bw/day retained from a 14-week dog study, applying a safety factor of 50.
Danish: En toksikologisk acceptabel daglig indtagelse (ADI) på 10 µg/kg kropsvægt/dag (600 µg/person pr. dag) blev bestemt på grundlag af den dødelige dosis på 0,5 mg/kg kropsvægt/dag, som var opnået fra en 14 uger lang undersøgelse af hunde, og med anvendelse af en sikkerhedsfaktor på 50.
English: Discussion of specific issues raised in the referral notification
Danish: Drøftelse af specifikke spørgsmål i meddelelsen om indbringelsen af sagen
English: Based on the 11 ivermectin residue depletion studies of adequate quality provided, the CVMP calculated the withdrawal periods for 12 products.
Danish: Baseret på de 11 indgivne restkoncentrationsundersøgelser af ivermectin af tilstrækkelig kvalitet beregnede CVMP tilbageholdelsestiderne for 12 produkter.
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.
Danish: Disse undersøgelser understøtter det synspunkt, at der i de undersøgelser, som var indgivet til CVMP, forekom kilder til variation, som var vigtigere end virkningerne af formuleringen.
English: Via Emilia, 285
Danish: Italien Fatro Via Emilia, 285
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.
Danish: Da MRL-muskelværdier for ivermectin ikke forefindes, blev den ADI-baserede metode anvendt til evaluering af den samlede daglige indtagelse af restkoncentrationer som følge af indtagelse af væv fra hvert dyr (EMEA/CVMP/542/03-Final)2.
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.
Danish: Af de samlede data, som var indsendt af indehaverne af markedsføringstilladelserne og de nationale kompetente myndigheder i medlemsstaterne, blev kun 11 restkoncentrationsundersøgelser af ivermectin anset for at være af tilstrækkelig kvalitet til at understøtte en beregning af tilbageholdelsestider, da der kun i disse undersøgelser var blevet indsamlet og analyseret relevant væv, inklusive injektionssteder.
English: VETERINA Plus d.o.o.,Dunajska 1000 Ljubljana,
Danish: Slovenien VETERINA Plus d.o.o.,Dunajska 1000 Ljubljana
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).
Danish: I disse undersøgelser udviste forskellige formuleringer forskellige absorptionsmønstre for avermectiner (herunder ivermectin), mens andre parametre var de samme (f.eks. art, race, vægt og injektionssted).
English: A safety span of 30% was used in view of the large variation in the intake figures, which was primarily caused by the variation of residues found in injection sites.
Danish: Der blev anvendt en sikkerhedsmargen på 30 % på baggrund af den store variation i indtagelsestallene, som primært skyldes variationen i restkoncentrationer på injektionsstederne.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF INJECTABLE VETERINARY MEDICINAL PRODUCTS CONTAINING IVERMECTIN
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF INJICERBARE VETERINÆRLÆGEMIDLER INDEHOLDENDE IVERMECTIN
English: Of the formulation groups to which products were allocated in this procedure, two contained combination products; one with products containing the active substances ivermectin and clorsulon, and the second with products containing the active substances ivermectin and closantel.
Danish: Blandt de formuleringsgrupper, som produkterne blev inddelt i under denne procedure, indeholdt to kombinationsprodukter; en med produkter indeholdende de aktive stoffer ivermectin og clorsulon og en anden med produkter indeholdende de aktive stoffer ivermectin og closantel.
English: An attempt was made to find a correlation between the slopes or intercepts of the depletion curves and any of the following parameters: formulation group, bodyweight, breed, sex, age, and injection volume, using ANOVA or Pearson's methodology.
Danish: Det blev forsøgt at finde en sammenhæng mellem koncentrationskurvernes hældninger eller skæringspunkter og hver af følgende parametre: formuleringsgruppe, kropsvægt, race, køn, alder og injektionsvolumen ved hjælp af ANOVA- eller Pearson-metoden.
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.
Danish: Hvad angår produkter, som har vist sig at være bioækvivalente, skal det principielt bemærkes, at definitionen af bioækvivalens ikke garanterer ens niveauer af restkoncentrationer på injektionsstedet længe efter de tidspunkter, hvor plasmaprøverne blev taget.
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.
Danish: Ud fra de tilgængelige data blev der ikke fundet nogen sammenhænge, der kunne forklare forskellen i koncentrationsprofiler eller beregnede tilbageholdelsestider, og ingen af de registrerede parametre kunne identificeres som en stor enkelt kilde til variation.
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).
Danish: Af tabel 1 ovenfor fremgår det, at intervallet for beregnede tilbageholdelsestider for gruppe 1, hvor et antal undersøgelser var tilgængelige, varierede betydeligt (fra 21 til >49 dage).
English: No suitable data No suitable data No suitable data
Danish: Ingen egnede data Ingen egnede data Ingen egnede data
English: 01-048 Warsaw Poland
Danish: 01-048 Warsawa Poland
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.
Danish: Ser man på de samlede restkoncentrationsdata for clorsulon, kunne den statistiske metode ikke anvendes til beregning af tilbageholdelsestiden, da de relevante statistiske antagelser ikke var opfyldt.
English: Therefore, a withdrawal period of at least 49 days will apply for the combination products in all cases.
Danish: Derfor gælder der i alle tilfælde en tilbageholdelsestid på mindst 49 dage for kombinationsprodukter.
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.
Danish: Det højeste variationsniveau i restkoncentrationer og koncentrationsprofiler konstateret inden for og på tværs af formuleringsgrupperne, kan nemt have maskeret en virkning af formuleringen.
English: Slovak Republic CEVA Animal Health Slovakia, spol.
Danish: Slovakiet CEVA Animal Health Slovakia, spol.
English: Scanvet Eläinlääkkeet Oy PL 27
Danish: Finland Scanvet Eläinlääkkeet Oy PL 27
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).
Danish: De data, der blev undersøgt af CVMP, resulterede i beregning af forskellige tilbageholdelsestider for produkter, der er ens i det væsentlige, men denne variabilitet vurderes ikke at afspejle de produktspecifikke virkninger, men vurderes i stedet at være et resultat af den måde, hvorpå produkterne anvendes (dvs. at variationen opstår som følge af forskelle, som f.eks. dyrets kropsvægt, race, køn, injektionsvolumen og prøvetagningsprocedure).
English: Merial Italia S.p.A. a Socio Unico, Via Vittor Pisani, 16
Danish: a Socio Unico Via Vittor Pisani, 16
English: z.o.o., Dzierzoniwska street 21
Danish: Dzierzoniwska street 21
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.
Danish: Da ækvivalensen af lokale restkoncentrationer på injektionsstedet ikke kan forudsiges ud fra bioækvivalensen af plasma, og fordi offentliggjorte data viser, at formuleringen kan have en indvirkning på restkoncentrationsprofilerne for ivermectin, vurderede CVMP, at der generelt ikke er grundlag for automatisk at ekstrapolere en tilbageholdelsestid, som er fastlagt for én formulering, til en anden formulering, selv om bioækvivalens af plasma er blevet påvist.
English: Kosynierów Gdyńskich 13-14, 66-400 Gorzów Wlkp., Poland
Danish: Kosynierów Gdyńskich 13-14 66-400 Gorzów Wlkp.
English: Veterina Polska Sp. Zo.o.
Danish: Ungarn Veterina Polska Sp. Zo.o.
English: Bayer Hungária Ltd. H-1123 Budapest Alkotás u. 50.
Danish: Ungarn Bayer Hungária Ltd. H-1123 Budapest Alkotás u. 50.
English: United Kingdom Alstoe Ltd Sheriff Hutton Industrial Park Sheriff Hutton
Danish: Sheriff Hutton Industrial Park Sheriff Hutton
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.
Danish: Ved anvendelsen af den alternative metode i forbindelse med data fra de individuelle restkoncentrationsundersøgelser blev tilbageholdelsestiden beregnet fra det første tidspunkt, hvor alle beregnede indtagelser var under ADI-værdien, med tilføjelse af en sikkerhedsmargen.
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).
Danish: På baggrund af de samlede data og på baggrund af den kendsgerning, at den beregnede indtagelse på og efter dag 49 kun ligger over ADI-værdien for to dyr, vurderede udvalget, at en tilbageholdelsestid på 49 dage ville sikre en sikkerhedsgrad svarende til den, der blev beregnet ved hjælp af den statistiske metode (og en tilbageholdelsestid baseret på tolerancetærsklen på 95 %).
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.
Danish: Variabiliteten i beregnede tilbageholdelsestider afspejler variabiliteten i koncentrationsprofilerne og navnlig variabiliteten i restkoncentrationerne fra injektionsstedet.
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.
Danish: Et centralt spørgsmål i denne procedure er, om der forekommer en virkning af formuleringen i restkoncentrationer fra væv og navnlig fra injektionsstedet.
English: In the figure below, all available data for the total intake of ivermectin residues is plotted and compared to the ADI.
Danish: I figuren nedenfor afbildes alle tilgængelige data vedrørende den samlede indtagelse af ivermectinreststoffer sammenlignet med ADI-værdien.
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.
Danish: Det skal bemærkes, at spredningen af data for mange af undersøgelserne bevirkede, at den harmoniserede statistiske metode til beregning af tilbageholdelsestider ikke kunne anvendes, og den tilbageholdelsestid, der fås ved brug af den alternative metode, er stærkt afhængig af valget af tidspunkter.
English: Other sources of variation connected to the subcutaneous use of ivermectin were therefore considered to be of more importance than formulation with regard to residue depletion and withdrawal periods.
Danish: Andre kilder til variation i forbindelse med subkutan injektion af ivermectin blev derfor vurderet at være af større betydning end formuleringen, hvad angår restkoncentrationer og tilbageholdelsestider.
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;
Danish: • Udvalget vurderede de oprindelige data, der er indgivet i forbindelse med denne procedure, og konkluderede, at en virkning af formuleringen på restkoncentrationen på baggrund af disse data ikke kunne påvises, og at variabiliteten i dataene bevirkede, at en virkning af formuleringen på restkoncentrationen kunne have været maskeret.
English: 83 102 BRATISLAVA
Danish: 83 102 BRATISLAVA Slovak Republic
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: Belgium MERIAL Belgium S.A. Bld Sylvain Dupuis 243
Danish: Belgien MERIAL Belgium S.A. Bld Sylvain Dupuis 243
English: 08028 Barcelona,
Danish: 08028 Barcelona Spain
English: Divasa Farmavic Hungaria Ltd. H-6070 Izsák, Kossuth L. u. 60.
Danish: Ungarn Divasa Farmavic Hungaria Ltd. H-6070 Izsák, Kossuth L. u. 60.
English: 27540 Bremerhaven
Danish: 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.
Danish: Hos kvæg bruges injicerbare veterinærlægemidler indeholdende ivermectin enten som et enkelt aktivt stof eller i kombination med et andet aktivt stof mod angreb af endoparasitter og ectoparasitter ved subkutan indgivelse af 200 μg ivermectin/kg kropsvægt.
English: Bremer Pharma GmbH.
Danish: Ungarn Bremer Pharma GmbH.
English: Intervet International B.V. Wim de Korvrstraat 35, 5831 AA, Boxmeer, The Netherlands
Danish: Bulgarien Bulgarien Wim de Korvrstraat 35 5831 AA, Boxmeer The Netherlands
English: Since the withdrawal period calculated based on the clorsulon component for these product exceeds the 49 days derived for the ivermectin component, 66 days is recommended as the withdrawal period for the combination products containing ivermectin and clorsulon.
Danish: Da tilbageholdelsestiden bestemt på grundlag af clorsulonkomponenten for disse produkter overstiger de 49 dage udledt for ivermectinkomponenten, anbefales 66 dage som tilbageholdelsestid for kombinationsprodukter indeholdende ivermectin og clorsulon.
English: INTERVET PRODUCTIONS SRL Via Nettunense km 20, 300 04011 Aprilia
Danish: Via Nettunense km 20, 300 04011 Aprilia
English: Slovak Republic Pharmagal spol.s.r.o.
Danish: Slovakiet Pharmagal spol.s.r.o.
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).
Danish: Den samlede indtagelse af ivermectinreststoffer (µg) for en forbruger beregnet ud fra data for hvert dyr (datapunkter) sammenlignet med ADI-værdien (µg/person, vandret linje) på en logaritmisk skala.
English: If the withdrawal period determined on the basis of residue depletion data for the second active substance is less than 49 days, then a withdrawal period of 49 days is recommended for the product.
Danish: Hvis tilbageholdelsestiden bestemt på grundlag af restkoncentrationsdata for det andet aktive stof er mindre end 49 dage, anbefales tilbageholdelsestiden på 49 dage for produktet.
English: Overall, from the data examined, the presence of a formulation effect can neither be confirmed nor refuted.
Danish: En effekt af formuleringen kan samlet set hverken bekræftes eller afvises på baggrund af de undersøgte data.
English: The harmonised withdrawal period of 49 days is relevant only to the ivermectin component of injectable products containing ivermectin.
Danish: Den harmoniserede tilbageholdelsestid på 49 dage er kun relevant for ivermectinkomponenten af injicerbare produkter indeholdende ivermectin.
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.
Danish: Da variationen i restkoncentrationsprofiler som følge af kilder til variation i den subkutane injektion af ivermectin er meget større end virkningen af formuleringen, vurderede udvalget endvidere, at de samlede restkoncentrationsdata for ivermectin fra alle formuleringsgrupper skulle anvendes til at beregne én harmoniseret tilbageholdelsestid.
English: 2.1 Calculation of a harmonised withdrawal period for ivermectin containing injectable products for use in cattle
Danish: 2.1 Beregning af harmoniseret tilbageholdelsestid for injicerbare produkter indeholdende ivermectin til kvæg
English: Ivomec 10 mg/ml Injektionssuspensi on für Rinder, Schafe und Schweine
Danish: Ivomec 10 mg/ml Injektionssuspension für Rinder, Schafe und Schweine