FrancophonIA/ELRC3.0 huggingface dataset:
English: In the majority of cases transfer of substances from blood plasma to milk (and vice versa) is governed by simple diffusion across the mammary gland epithelium (Rasmussen, 1966); active transport has been rarely reported (Ito and Lee, 2003)3.
Danish: I de fleste tilfælde styres stofoverførslen fra blodplasma til mælk (og omvendt) ved simpel diffusion hen over epitelet i kirtlerne i yveret (Rasmussen, 1966); aktiv transport er sjældent blevet rapporteret (Ito og Lee, 2003)3.
English: The available data relating to residues in milk following oral administration (study 3) showed a slow but clear depletion of residues in milk in the days after calving.
Danish: De foreliggende data om restkoncentrationer i mælk efter oral administration (undersøgelse 3) viste en langsom, men klar nedbrydelse af restkoncentrationer i mælk i dagene efter kælvning.
English: Data are available on plasma closantel levels following oral administration (study 2 above) at the recommended dose.
Danish: Der findes data for plasmakoncentrationen af closantel efter oral administration (undersøgelse 2 ovenfor) ved den anbefalede dosis.
English: Half-lives reported for closantel range between 10.8 and 24 days.
Danish: Halveringstiden for closantel er bestemt til mellem 10,8 og 24 dage.
English: in which T = time (days), dose = total dose (g/kg bw/day), duration = treatment duration (days), bw = bodyweight (kg), A = Avogadro's number = 6.0 * 1023, M = Molar mass (g/mol), t1/2 = terminal elimination half-life (h), and in which
Danish: hvor T = tid (dage), dose = totaldosis (g/kg kropsvægt/dag), duration = behandlingsvarighed (dage), bw = kropsvægt (kg), A = Avogadros tal = 6,0 * 1023, M = molarmasse (g/mol), t1/2 = terminal eliminationshalveringstid (h), og hvori
English: Fluken worm Rafoxanide Levamisole
Danish: Fluken worm Rafoxanid Levamisol
English: Intervet Ireland Ltd Magna Drive Magne Business Park Citywest Road Dublin 24
Danish: Intervet Irland Ltd Magna Drive Magne Business Park Citywest Road Dublin 24
English: Merial Italia S.p.A. via Vittorio Pisani, 16 20100 Milano ITALY
Danish: via Vittorio Pisani, 16 20100 Milano ITALIEN
English: The ‘SCLR' (Safe concentrations based on linear regression)4 method was used to extrapolate from the combined plasma depletion data available for the two formulations used in study 2.
Danish: Der blev anvendt SCLR (“Safe concentrations based on linear regression”)4 til ekstrapolering fra de kombinerede data fra nedbrydelse i plasma for de to formuleringer i undersøgelse 2.
English: For the purposes of this referral this can be equated to 1 year.
Danish: I denne indbringelse kan dette sættes lig et år.
English: The time required for plasma closantel levels to deplete to 2250 μg/l was calculated to be 1780 hours (approximately 75 days) for one formulation and 1931 hours (approximately 81 days) for the other formulation.
Danish: Tiden til nedbrydelse af plasmakoncentrationen af closantel til 2 250 μg/l blev beregnet til 1 780 timer (ca. 75 dage) for den ene formulering og 1 931 timer (ca. 81 dage) for den anden formulering.
English: It is acknowledged that the guidance relates to methods for establishing withdrawal periods for milk, however, because the type of data to be evaluated in this referral is similar to that typically evaluated for the establishment of withdrawal periods, the use of these approaches is considered appropriate here.
Danish: Det vedgås, at den nævnte vejledning omhandler metoder til fastlæggelse af tilbageholdelsestider for mælk, men da denne indbringelse vedrører data af samme type som dem, der typisk evalueres til fastsættelse af tilbageholdelsestider, anses det for hensigtsmæssigt at benytte disse metoder her.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants producing milk for human consumption (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af veterinærlægemidler, som indeholder aktive stoffer tilhørende klassen trematodemidler, for hvilke der ikke er fastsat maksimalgrænseværdier for restkoncentrationer i mælk, og som er bestemt til brug hos drøvtyggere, der producerer mælk til menneskeligt konsum (se bilag I)
English: The relevant sections of the package leaflets for all products concerned by this referral should be revised taking into account the recommendetions for section 4.11 Withdrawal period(s) of the SPC.
Danish: De pågældende afsnit af indlægssedlerne for alle lægemidler omfattet af denne indbringelse bør revideres under hensyntagen til anbefalingerne vedrørende produktresuméets afsnit 4.11 Tilbageholdelsestid.
English: Using linear regression to extrapolate from these data suggests that treatment would need to occur 136 days (i.e. 20 weeks) before calving (i.e. during the first half of the gestation period) in order to ensure that closantel levels in milk from the first milking would be below 45 μg/l.
Danish: Ekstrapolering fra disse data ved lineær regression viser, at behandlingen skal finde sted 136 dage (dvs. 20 uger) før kælvning (dvs. i første halvdel af drægtighedsperioden) for at sikre, at closantel-indholdet i mælk fra første malkning er under 45 µg/l.
English: It should be noted that many (155) of the clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole containing products are combination products containing other active substances.
Danish: Det bør bemærkes, at mange (155) af de lægemidler, der indeholder clorsulon, closantel, nitroxinil, rafoxanid eller triclabendazol, er kombinationslægemidler med andre aktive stoffer.
English: The re-examination related to the recommended amendments of section 4.11 Withdrawal period(s) of the SPC for the veterinary medicinal products containing nitroxinil that are administered to cattle.
Danish: Den fornyede overvejelse vedrørte de anbefalede ændringer af afsnit 4.11 Tilbageholdelsestid i produktresuméet for veterinærlægemidler indeholdende nitroxinil, der administreres til kvæg.
English: Half-lives reported for rafoxanide range between 7 and 16.6 days.
Danish: For rafoxanid er beskrevet halveringstider mellem 7 og 16,6 dage.
English: The results showed that the marker residue in milk at the first milking is below the safe concentration when a pre-calving period of 2 months is respected.
Danish: Resultaterne viste, at koncentrationen af restmarkør i mælk ved første malkning er under den sikre koncentration, når der overholdes en periode på 2 måneder før kælvning.
English: Laboratorios Cenavisa, s.a. Cami Pedro Estela, S/N 43205 Reus (Tarragona) SPAIN
Danish: Laboratorios Cenavisa, s.a. Cami Pedro Estela, S/N 43205 Reus (Tarragona) SPANIEN
English: Using this value and the plasma concentrations of clorsulon recorded in study 2 reported above, the time required for depletion of residues to a safe concentration was calculated.
Danish: Ved hjælp af denne værdi og plasmakoncentrationerne af clorsulon fra ovennævnte undersøgelse 2 beregnedes den tid, der er nødvendig til nedbrydelse af restkoncentrationerne til et risikofrit niveau.
English: Quinn's Chemist Bridge Street Crossmolina Co. Mayo IRELAND
Danish: Quinn's Chemist Bridge Street Crossmolina Co. Mayo IRLAND
English: Plasma and milk concentrations of closantel in cattle were reported following a single intramuscular dose.
Danish: Koncentrationerne af closantel i plasma og mælk hos kvæg blevet registreret efter en enkelt intramuskulær dosis.
English: Bomac Laboratories Limited Cnr Wiri Station Road & Hobill Ave
Danish: Rumænien Bomac Laboratories Limited Cnr Wiri Station Road & Hobill Ave
English: Flukicides play a critical role in the prevention and control of trematode infections.
Danish: Trematodemidler er kritisk vigtige til forebyggelse og kontrol af infektioner med trematoder.
English: With regard to veterinary medicinal products containing triclabendazole and moxidectin and administered as pour-on to cattle (see Annex I), the Committee concluded that any use in dairy animals might result in unacceptable residue levels in milk.
Danish: For pour-on veterinærlægemidler, der indeholder triclabendazol og moxidectin og anvendes til kvæg (se bilag I), konkluderede udvalget, at enhver anvendelse til mælkeproducerende dyr kan medføre uacceptable restkoncentrationer i mælk.
English: As the elimination rate is equal for all compartments of the body during the terminal phase of elimination, the time needed to eliminate a drug from the body can be estimated by applying the terminal elimination half-life for the substance to the total number of molecules administered.
Danish: Da udskillelseshastigheden i den terminale udskillelsesfase er den samme for alle kroppens kompartmenter, kan tiden til udskillelse af et lægemiddel af kroppen beregnes ved at anvende stoffets terminale eliminationshalveringstid på det totale antal administrerede molekyler.
English: In addition, as depletion of nitroxinil residues in milk will be affected by the time between treatment and calving and as, in practice, the calving date is difficult to predict, it is not considered appropriate to express the time period that needs to elapse following product administration in terms of a precise number of days to calving.
Danish: Desuden vil nedbrydelsen af restkoncentrationer af nitroxinil i mælk afhænge af tidsrummet mellem behandling og kælvning, og da kælvningsdatoen i praksis er vanskeligt at forudsige, anses det ikke for hensigtsmæssigt at angive det tidsrum, der skal gå efter administration af lægemidlet, som et nøjagtigt antal dage til kælvning.
English: It should be noted that while the recommended time spans reflect safe exposure levels for the consumer, residues (at safe levels) may still be found in milk upon control.
Danish: Det bør nævnes, at skønt de anbefalede tidsrum afspejler risikofrie eksponeringsniveauer af forbrugeren, vil der stadig kunne findes restkoncentrationer (af en risikofri størrelse) ved kontrol af mælk.
English: In particular, no statistical analysis of the available milk residue depletion study was available with the result that intersubject variability was not taken into account.
Danish: Specielt forelå der ingen statistisk analyse af den foreliggende restkoncentrationsundersøgelse i mælk, hvilket resulterer i, at den interindividuelle variabilitet ikke er taget i betragtning.
English: The data did not show a clear relationship between the length of the dry period and closantel levels in milk from the first milking, and consequently could not be used to determine a time point at which administration could be considered safe for the consumer.
Danish: Dataene viste ikke noget klart forhold mellem goldperiodens længde og koncentrationen af closantel i mælk fra første malkning; de kunne derfor ikke anvendes til bestemmelse af et tidspunkt, hvor administrationen kan anses for risikofri for forbrugeren.
English: The residue depletion study following pour-on administration (study 2) showed that residues were detectable in a small number of animals, sometimes in excess of 10 µg/l.
Danish: Restkoncentrationsundersøgelsen efter administration af pour-on (undersøgelse 2) viste påviselige restkoncentrationer i et lille antal dyr, undertiden over 10 µg/l.
English: 78 days
Danish: 78 dage
English: After reviewing the documentation submitted by the marketing authorisation holder and after considering the information provided during the oral explanation, the CVMP concluded that there were not sufficient scientific grounds to revise its conclusions of 8 March 2012 on the restrictions that should be applied to the use of nitroxinil in dairy cattle in order to avoid residues in milk occurring at levels that could compromise consumer safety.
Danish: Efter gennemgang af den af indehaveren af markedsføringstilladelsen forelagte dokumentation og de fremlagte oplysninger ved den mundtlige fremlæggelse konkluderede CVMP, at der ikke var tilstrækkeligt videnskabeligt grundlag for at revidere udvalgets konklusioner af 8. marts 2012 om begrænsninger, som brug af nitroxinil hos malkekøer bør underkastes for at undgå restkoncentrationer i mælk af en størrelse, der kan bringe forbrugernes sikkerhed i fare.
English: Pharmacokinetic study following oral administration of 14C-triclabendazole.
Danish: Farmakokinetisk undersøgelse efter oral administration af 14C-triclabendazol.
English: While this period of one year is markedly longer than the period of 12 days established for subcutaneously administered clorsulon, it is noteworthy that the only identified oral administration pharmaceutical form containing clorsulon as a single active substance is a bolus, for which the conservative default value is considered appropriate.
Danish: Et tidsrum på et år er markant længere end de 12 dage, der er fastsat for clorsulon efter subkutan administration, men det bør her bemærkes, at det eneste foreliggende orale præparat med clorsulon som eneste aktive stof er en bolus, for hvilken den restriktive standardværdi anses for passende.
English: Pol. Ind. De Vallecas Madrid
Danish: De Vallecas Madrid
English: However, it was noted that, in many cases, adequate residue depletion data in milk from dairy animals treated during the non-lactating period is not available.
Danish: Det blev imidlertid konstateret, at der i mange tilfælde ikke foreligger tilstrækkelige restkoncentrationsdata for mælk fra mælkeproducerende dyr, der er behandlet i den ikke-lakterende periode.
English: Interchem Ireland Ltd Road M
Danish: Interchem Irland Ltd Road M
English: Tablets oral
Danish: Tabletter oral
English: However, closantel depletion profiles have been shown to be similar in milk and plasma, with a milk to plasma ratio of 0.02 (study 5 above).
Danish: Nedbrydelsesprofilerne af closantel i mælk og plasma har imidlertid vist sig at svare til hinanden med et forhold mælk/plasma på 0,02 (undersøgelse 5 ovenfor).
English: If no such data are available, the milk to plasma ratio could, in principle, be calculated on the basis of the pKa, degree of lipid solubility (ie the relative concentrations of ionised and unionised free drug), the degree of protein binding in plasma and milk, and assuming standard pH values for plasma and milk (Rasmussen, 1966).
Danish: Foreligger der ikke sådanne data, kan forholdet mellem mælk og plasma i princippet beregnes på grundlag af pKa, fedtopløseligheden (dvs. at de relative koncentrationer af ioniseret og uioniseret frit lægemiddel), proteinbindingsgraden i plasma og mælk samt forudsætninger om normale pH-værdier i plasma og mælk (Rasmussen, 1966).
English: The marketing authorisation holder concluded that a period of 71 days between product administration and calving would be sufficient to ensure consumer safety and that such a time span would still allow use of nitroxinil in dry cattle, thus improving treatment options.
Danish: Indehaveren af markedsføringstilladelsen konkluderede, at en periode på 71 dage mellem administration af lægemidlet og kælvning er tilstrækkelig til at garantere forbrugernes sikkerhed, og at dette tidsrum vil give mulighed for anvendelse af nitroxinil hos goldkøer, hvorved behandlingsmulighederne bliver bedre.
English: D-48308 Senden-Bösensell GERMANY
Danish: D-48308 Senden-Bösensell TYSKLAND
English: While residues of nitroxinil in milk may be present largely as nitroxinil (as is the case in fat), there have also been reports of nitroxinil conjugates in milk (Whelan et al., 2011).
Danish: Restkoncentrationerne af nitroxinil i mælk kan tænkes hovedsagelig at foreligge som nitroxinil (ligesom i fedtvæv), men der er også beskrevet konjugater af nitroxinil i mælk (Whelan et al., 2011).
English: The milk to plasma ratio for a substance can be established based on empirical data (i.e. measured levels of the substance in plasma and milk at equal time points).
Danish: Mælk/plasma-forholdet for et stof kan fastlægges ud fra empiriske data (dvs. samtidige bestemmelser af stoffet i plasma og mælk).
English: Both the immature and mature flukes are harmful to the target species, and each flukicide has varying efficacy against different ages of fluke.
Danish: Både de umodne og modne trematoder er skadelige for måldyrearten, og de forskellige trematodemidler har forskellig virkning mod trematoder i forskellige aldre.
English: CT13 9NJ UNITED KINGDOM
Danish: CT13 9NJ
English: While no evidence was available to indicate that the pharmacokinetic and residue depletion behaviour following administration of the different nitroxinil containing products would be identical to that seen in the available study, the conservative approach adopted in the interpretation of the available data ensures that the resulting recommendation is valid for all nitroxinil containing products.
Danish: Der var ikke dokumentation for, at de farmakokinetiske forhold og restkoncentrationsnedbrydelsen efter administration af de forskellige lægemidler indeholdende nitroxinil vil være identiske med dem, der er fundet i den foreliggende undersøgelse, men ved restriktiv tolkning af de foreliggende data sikres, at den resulterende anbefaling er gyldig for alle lægemidler indeholdende nitroxinil.
English: Univet Limited Tullyvin Cootehill Co. Cavan IRELAND
Danish: Univet Limited Tullyvin Cootehill Co. Cavan IRLAND
English: Due to the absence of a MRL in milk these products are not authorised for use in lactating animals.
Danish: På grund af de manglende maksimalgrænseværdier for restkoncentrationer i mælk er disse lægemidler ikke godkendt til anvendelse hos lakterende dyr.
English: From these 251 veterinary medicinal products, 96 contain one of the substances mentioned above as a single active substance and the remaining 155 are combination products containing a second non-flukicidal active substance.
Danish: Af disse 251 veterinærlægemidler indeholder 96 et af ovennævnte stoffer som eneste aktive stof.
English: Outcome
Danish: Resultat
English: It should also be noted that since the commencement of this referral, MRLs have been recomended for clorsulon in bovine milk, for closantel and nitroxinil in bovine and ovine milk, and for triclabendazole in milk of all ruminants.
Danish: Det bør desuden nævnes, at der siden indledningen af denne indbringelse er fremsat anbefalinger for maksimalgrænseværdier for restkoncentrationer af clorsulon i komælk og for closantel og nitroxinil i komælk og fåremælk samt for triclabendazol i mælk fra alle drøvtyggere.
English: Available data
Danish: Foreliggende data
English: The Committee agreed that, in such cases, and where possible, milk concentrations could be estimated by extrapolation from plasma concentrations.
Danish: Udvalget fandt, at koncentrationerne i mælk i sådanne tilfælde må beregnes ved ekstrapolering fra plasmakoncentrationerne, når dette er muligt.
English: 15 Fleming Street Maroussi 15123 GREECE
Danish: Grækenland New Vet 15 Fleming Street Maroussi 15123
English: Oral solution Information not available
Danish: Oral opløsning Ingen oplysninger foreligger
English: In making recommendations for safe time spans to be applied between administration of a product and collection of milk for human consumption, consideration will also be given to ensuring compatibility with normal animal husbandry practices.
Danish: I anbefalingerne for de sikre tidsintervaller, der skal gå mellem administration af lægemiddel og malkning til menneskeligt konsum, vil det desuden blive taget i betragtning, om de er forenelige med normal praksis i husdyrbrug.
English: The data from this residue study in milk were not suitable for determination of a safe pre-calving interval.
Danish: Tallene fra denne restkoncentrationsundersøgelse i mælk var ikke egnede til fastsættelse af et sikkert tidsrum før kælvning.
English: The control of liver fluke is achieved primarily by treatment with veterinary medicinal products containing flukicidal substances and is also assisted by appropriate husbandry measures (e.g. not grazing low-lying pastures or wet pastures near ponds and streams).
Danish: Kontrol med leverikten opnås hovedsagelig ved behandling med iktedræbende veterinærlægemidler samt passende opdrætspraksis (f.eks. undgåelse af græsning på lavtliggende områder eller våde græsgange nær damme og vandløb).
English: A single study using a single product was available relating to the use of nitroxinil in milk producing cattle.
Danish: Der forelå en enkelt undersøgelse med et enkelt lægemiddel vedrørende brug af nitroxinil til malkekøer.
English: Triclabendazole Ivermectin mg/tablet mg/tablet
Danish: Triclabendazol Ivermectin mg/tablet mg/tablet
English: Novartis Tiergesundheit GmbH Zielstattstr.
Danish: Tyskland Novartis Tiergesundheit GmbH Zielstattstr.
English: 136 days
Danish: 136 dage
English: Other deficiencies in the study, including the fact that it was not GLP compliant and that only the draft study report was provided also reduce the robustness of the study.
Danish: Også andre mangler bidrog til at svække undersøgelsen, herunder, at den ikke var GLP-overensstemmende, og at der kun blev forelagt et udkast til undersøgelsesrapporten.
English: Pasteur - Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
Danish: Rumænien Pasteur - Filiala Filipesti SRL Str. Principala nr. 944
English: Flukex 9% Rafoxanide
Danish: Flukex 9 % Rafoxanid
English: 60 days
Danish: 60 dage
English: The flukicidal substances for which a MRL has not been established in milk and that are included as active substances in authorised veterinary medicinal products in the Member States (EU/EEA) are clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole.
Danish: De trematodemidler, for hvilke der ikke er fastsat maksimalgrænseværdier for restkoncentrationer i mælk, og som indgår som aktive stoffer i godkendte veterinærlægemidler i medlemsstaterne (EU/EØS), er clorsulon, closantel, nitroxinil, rafoxanid og triclabendazol.
English: However, nitroxinil was established as the marker residue in cattle tissues (CVMP Summary Report, 1998), and is known to be the major residue present in fat, muscle, kidney and plasma.
Danish: Nitroxinil blev imidlertid udpeget som restmarkør i væv fra kvæg (CVMP Summary Report, 1998) og vides at være den vigtigste rest i fedtvæv, muskel, nyre og plasma.
English: 272 days
Danish: 272 dage
English: This could result in consumer exposure to residues of closantel over the ADI.
Danish: Forbrugerne kan således blive eksponeret for restkoncentrationer af closantel, der overstiger ADI-værdien.
English: It is therefore concluded that use of oral triclabendazole-containing products should take place during the first or second trimesters (and not during the third trimester) of the gestation period.
Danish: Det konkluderes derfor, at oral anvendelse af triclabendazolholdige lægemidler bør finde sted i første eller andet trimester (men ikke i tredje trimester) af drægtighedsperioden.
English: However, based on the results of study 1 the milk/serum concentration ratio of rafoxanide (measured as radiolabelled Iodine in chloroform extract) was approximately 1/30.
Danish: Undersøgelse 1 viste imidlertid et koncentrationsforhold mælk/serum for rafoxanid (målt som radiomærket jod i kloroformekstrakt) på ca. 1/30.
English: The only available residue study (study 1) demonstrates that milk from animals whose dry period lasted at least 71 days did not contain nitroxinil at levels above 20 μg/l.
Danish: Den eneste foreliggende restkoncentrationsundersøgelse (undersøgelse 1) viser, at mælk fra dyr, hvis goldperiode varede mindst 71 dage, ikke indeholdt nitroxinil i koncentrationer over 20 μg/l.
English: The time required for closantel levels in plasma to deplete to 2250 μg/l following pour-on application to animals at the same time point was calculated to be 119 days.
Danish: Den tid, der gik, før plasma-closantel var depleteret til 2 250 μg/l efter samtidig påføring af pour-on på dyrene, beregnedes til 119 dage.
English: Do not use during last trimester of gestation period
Danish: Må ikke anvendes i sidste trimester af drægtighedsperioden