FrancophonIA/ELRC3.0 huggingface dataset:
English: Residue depletion study following a single oral administration of 10 mg/kg bw closantel to 11 pregnant cows 40 to 45 days before expected calving.
Danish: Restkoncentrationsundersøgelse efter oral enkeltindgift af 10 mg/kg kropsvægt closantel til 11 drægtige køer 40-45 dage før forventet kælvning.
English: Closantel Invermectine
Danish: Closantel Invermectin
English: Based on these data it was concluded that triclabendazole residues in milk from animals treated 2 to 15 days before calving could be sufficiently high to result in total exposure of residues (in the foodbasket) over the ADI.
Danish: Heraf konkluderedes, at restkoncentrationerne af triclabendazol i mælk fra dyr, der er behandlet 2-15 dage før kælvning, kan være så høje, at den totale eksponering for restkoncentrationer (i kurven med fødevarer) overstiger ADI-værdien.
English: Parsifal Bovins Triclabendazole Levamisole
Danish: Parsifal Bovins Triclabendazol Levamisol
English: Plasma and milk levels of clorsulon were recorded.
Danish: Koncentrationen af clorsulon i plasma og mælk blev bestemt.
English: Although 119 days was considered sufficient to allow for the depletion of residues of closantel to a safe concentration, as ivermectin was not within the scope of this referral and was therefore not evaluated, it was not possible to conclude whether 119 days would also allow residues of ivermectin to deplete to safe levels.
Danish: 119 dage blev anset for tilstrækkeligt til nedbrydelse af restkoncentrationerne af closantel til et risikofrit niveau, men det kunne ikke konkluderes, om 119 dage er tilstrækkeligt til nedbrydelse af restkoncentrationerne af ivermectin, da ivermectin ikke er omfattet af denne indbringelse og derfor ikke blev evalueret.
English: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss GERMANY
Danish: Tyskland Janssen-Cilag GmbH Johnson & Johnson Platz 1
English: Pharmacokinetic study in which 5 heifers and 4 steers were administered a single (oral) dose 10 mg/kg bw 14C-labelled closantel by intubation into the rumen.
Danish: Farmakokinetisk undersøgelse, hvor fem kvier og fire tyrekalve fik en enkelt (oral) dosis på 10 mg/kg kropsvægt 14C-mærket closantel ved intubation i vommen.
English: Furthermore, use of the pharmacokinetic diffusion model based on pKa and protein binding is not possible in this case because information on the level of protein binding is sheep milk is not available (it is known that the binding to sheep milk proteins can deviate significantly from that to cattle milk proteins).
Danish: Desuden kan man her ikke anvende den farmakokinetiske diffusionsmodel baseret på pKa og proteinbinding, da der ikke foreligger oplysninger om omfanget af proteinbindingen i fåremælk (det vides, at proteinbindingen i fåremælk afviger betydeligt fra proteinbindingen i komælk).
English: It is concluded that use of rafoxanide containing products administered orally should take place during the first or second trimesters (and not during the third trimester) of the gestation period in order to ensure that residues in milk would not be at a level that could result in total exposure to residues over the ADI.
Danish: Det kan konkluderes, at oral anvendelse af lægemidler indeholdende rafoxanid bør ske i første eller andet trimester (men ikke i tredje trimester) af drægtighedsperioden for at sikre, at restkoncentrationerne i mælk ikke medfører en samlet eksponering, som overstiger ADI-værdien.
English: Novartis Consumer Health B.V. Claudius Prinsenlaan 142 4818 CP Breda
Danish: Claudius Prinsenlaan 142 4818 CP Breda
English: Seponver Plus Closantel Mebendazole
Danish: Seponver Plus Closantel Mebendazol
English: However, data are available on plasma closantel levels following subcutaneous administration (study 3) and, as indicated above, the level of closantel in milk can be considered to be safe when the level in plasma is below 2250 μg/l.
Danish: Derimod foreligger der data om plasmakoncentrationen af closantel efter subkutan indgift (undersøgelse 3), og som nævnt kan koncentrationen af closantel i mælk anses for risikofri, når plasmaniveauet er under 2 250 μg/l.
English: Schippers Europe B.V. Rond Deel 12
Danish: Nederlandene Schippers Europe B.V.
English: Residue depletion study in milk following a single pour-on application of 20 mg/kg bw triclabendazole to 18 pregnant cows 60 days prior to expected calving.
Danish: Restkoncentrationsundersøgelse efter en enkelt påføring af 20 mg /kg kropsvægt triclabendazol pour-on til 18 drægtige køer 60 dage før forventet kælvning.
English: Plasma clorsulon levels were monitored for up to 35 days after administration (GLP compliant).
Danish: Plasmaindholdet af clorsulon blev fulgt i op til 35 dage efter administrationen (GLP-overensstemmende undersøgelse).
English: Furthermore, use of the pharmacokinetic diffusion model was not possible as information on the pKa and protein binding for triclabendazole residues that make up the marker residue are not available.
Danish: Desuden kunne den farmakokinetiske diffusionsmodel ikke anvendes, da der ikke foreligger oplysninger om pKa eller proteinbinding for triclabendazol, som er restmarkøren.
English: Based on this it was estimated that the safe level in milk (45 µg/l) would occur when the plasma concentration of closantel is 2250 µg/l.
Danish: Heraf kunne det beregnes, at det risikofri niveau i mælk (45 µg/l) indtræder, når plasmakoncentrationen af closantel er 2 250 µg/l.
English: Based on the data from study 1 the ratio of rafoxanide to total residues in milk of cattle was approximately 0.25 to 0.35.
Danish: I henhold til undersøgelse 1 var forholdet mellem rafoxanid og de totale restkoncentrationer i komælk ca. 0,25-0,35.
English: Maagdenburgstraat 38 7421 ZE Deventer THE NETHERLANDS
Danish: 7421 ZE Deventer NEDERLANDENE
English: It is concluded that closantel administered subcutaneously should not be used during the dry period.
Danish: Det konkluderes, at subkutant indgivet closantel ikke bør anvendes i goldperioden.
English: Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM
Danish: 30 Turnhoutseweg B-2340 Beerse BELGIEN
English: Using the Time-To-Safe-Concentration (TTSC) method, the time point at which the 95th percentile of the treated population would have plasma closantel concentrations below 2250 μg/l with 95% confidence was calculated for each of the two formulations for which data were presented in study 3.
Danish: Ved hjælp af "Time-To-Safe-Concentration (TTSC)"metoden beregnedes det tidspunkt, på hvilket 95-percentilen at den behandlede population med 95 % sikkerhed har plasma-closantel under 2 250 μg/l for hver af de to formuleringer, som blev anvendt i undersøgelse 3.
English: Flukiver 50 mg/ml solução injectável para bovinos e ovinos
Danish: 50 mg/ml solução injectável para bovinos e ovinos
English: Having considered all the overall package of data submitted the CVMP concluded that the benefit-risk balance for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as single active substances (see Annex I) was positive provided that adequate instructions concerning use in dairy animals are included in section 4.11 Withdrawal period(s) of the SPC of the relevant products based on the time spans shown in the above table.
Danish: Efter gennemgang af samtlige forelagte data konkluderede CVMP, at risk/benefit-forholdet for veterinærlægemidler indeholdende clorsulon, closantel, nitroxinil, rafoxanid eller triclabendazol som eneste aktive stof (se bilag I) er positivt, forudsat at afsnit 4.11 Tilbageholdelsestid i produktresuméet for det pågældende lægemiddel indeholder passende anvisninger for anvendelse til mælkeproducerende dyr, baseret på tidsintervallerne i ovenstående tabel.
English: It was therefore considered appropriate to apply the marker to total residues ratio of 0.7, established for bovine fat, to milk as milk has a high fat content and limited metabolic activity (marker to total residues ratios established for bovine liver, kidney and muscle are 0.10, 0.80 and 1.00, respectively).
Danish: Det blev derfor anset for hensigtsmæssigt, at det forhold mellem restmarkør og totale restkoncentrationer på 0,7, der er fastlagt for fedtvæv fra køer, anvendes på mælk, da mælk har højt fedtindhold og begrænset metabolisk aktivitet (for lever, nyrer og muskel fra kvæg er forholdet mellem restmarkør og totale restkoncentrationer bestemt til henholdsvis 0,10, 0,80 og 1,00).
English: This referral sought to determine whether this use of these substances would result in residues in milk that, when combined with residues of these substances in other food commodities, could result in consumer exposure over the ADI.
Danish: I denne indbringelse er det søgt fastslået, om denne anvendelse af disse stoffer medfører restkoncentrationer i mælk, som sammen med restkoncentrationer af stofferne i andre fødevarer kan medføre en eksponering af forbrugerne, der overstiger ADI-værdien.
English: While this approach was acknowledged to be conservative, in the absence of alternative relevant data, it does provide a means for estimating a time point at which residues in milk can be concluded to be safe.
Danish: Skønt det må erkendes, at denne metode er restriktiv, kan den i mangel af andre relevante data anvendes til beregning af det tidspunkt, hvor restkoncentrationerne i mælk kan fastslås at være risikofrie.
English: Parsifal Ovins Triclabendazole Levamisole
Danish: Parsifal Ovins Triclabendazol Levamisol
English: Residue study in milk following oral administration of triclabendazole to cows around the time of calving.
Danish: Restkoncentrationsundersøgelse i mælk efter oral administration af triclabendazol til køer omkring kælvningstidspunktet.
English: In the absence of data in milk, any estimation of a marker to total residues ratio should be suitably conservative.
Danish: Da der ikke findes data for mælk, bør ethvert skøn over forholdet mellem en restmarkør og de totale restkoncentrationer være tilstrækkelig restriktivt.
English: Furthermore, use of the pharmacokinetic diffusion model based on pKa and protein binding is not possible in this case because information on the level of protein binding is sheep milk is not available.
Danish: Desuden kan man i dette tilfælde ikke anvende den farmakokinetiske diffusionsmodel baseret på pKa og proteinbinding, da der ikke foreligger oplysninger om graden af proteinbinding i fåremælk.
English: Triclabendazole Abamectin
Danish: Triclabendazol Abamectin
English: The CVMP was therefore requested to give its opinion as to whether measures are necessary to ensure that the use, during the non-lactating period, of veterinary medicinal products containing flukicidal substances for which a MRL has not been established in milk, would not lead to residues in milk that, combined with residues of these flukicidal substances from other foodstuffs, would result in consumer exposure exceeding the ADI.
Danish: CVMP blev derfor anmodet om at fremsætte en udtalelse om, hvorvidt der er behov for foranstaltninger til at sikre, at anvendelse uden for laktationsperioden af veterinærlægemidler indeholdende trematodemidler, for hvilke der ikke er fastsat maksimalgrænseværdier for restkoncentrationer i mælk, ikke medfører restkoncentrationer i mælk, som sammen med restkoncentrationer af sådanne trematodemidler fra andre levnedsmidler udsætter forbrugerne for større eksponering end svarende til ADI-værdien.
English: • the CVMP considered that the overall benefit-risk balance is positive for the products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as single active substances, and for the veterinary medicinal products administered as pour-on containing triclabendazole and moxidectin, subject to inclusion of adequate instructions and warning sentences concerning the use in dairy cattle in the product information;
Danish: • CVMP fandt det overordnede benefit/risk-forhold positivt for lægemidler indeholdende clorsulon, closantel, nitroxinil, rafoxanid eller triclabendazol som eneste aktive stof og for pour-on veterinærlægemidler indeholdende triclabendazol og moxidectin, forudsat at produktinformationen omfatter passende anvisninger og advarsler om anvendelse hos malkekvæg,
English: Slovenia
Danish: SLOVENIEN
English: As the scope of the referral was restricted to flukicidal substances only, the second active substance in the combination products was not evaluated.
Danish: Da denne indbringelse er begrænset til trematodemidler, blev det andet aktive stof i kombinationslægemidlerne ikke vurderet.
English: In the remainder of this opinion this is referred to as ‘the time needed to ensure a total residue burden equal to a safe number of molecules in 1.5 l milk'.
Danish: Dette betegnes i denne udtalelse efterfølgende som “den nødvendige tid til opnåelse af en total restkoncentrationsbelastning svarende til et sikkert antal molekyler i 1,5 l mælk”.
English: However, veterinary medicinal products containing closantel administered as pour-on and authorised in the Member States (EU/EEA) are all combination products containing ivermectin as second active substance.
Danish: De closantelholdige pour-on-lægemidler, der er godkendt i medlemsstaterne (EU/EØS), er imidlertid alle kombinationslægemidler med ivermectin som det andet aktive stof.
English: Residue depletion study following a single subcutaneous administration of 10 mg/kg bw nitroxinil to 35 pregnant cows.
Danish: Restkoncentrationsundersøgelse efter en subkutan enkeltdosis på 10 mg/kg kropsvægt nitroxinil til 35 drægtige køer.
English: The evaluation concludes that use of these substances during the non-lactating period could lead to residue levels in milk that are sufficient to result in consumer exposure over the ADI.
Danish: Vurderingen konkluderer, at anvendelse af disse stoffer i goldperioden kan medføre restkoncentrationer i mælk, der kan eksponere forbrugeren for mængder, der overstiger ADI-værdien.
English: Plasma radioactivity and closantel levels were monitored for up to 42 days after administration (non GLP).
Danish: Indholdet af radioaktivitet og closantel i plasma blev fulgt i op til 42 dage efter administrationen (ikke GLPoverensstemmende undersøgelse).
English: Merial B.V.
Danish: Nederlandene Merial B.V.
English: The remaining 5.6% of the ADI corresponds to 100 µg of closantel residues.
Danish: De resterende 5,6 % af ADI-værdien svarer til en restkoncentration af closantel på 100 µg.
English: Rafoxanide
Danish: Rafoxanid
English: A tissue residue depletion including data on plasma clorsulon levels was provided, in which forty cattle were administered single subcutaneous injections of 2 mg/kg bw clorsulon.
Danish: En restkoncentrationsundersøgelse i væv med plasmabestemmelse af clorsulon, hvor 40 stykker kvæg fik en enkelt subkutan injektion af clorsulon på 2 mg/kg kropsvægt.
English: BELGIUM
Danish: Belgien
English: Pharmacokinetic study in which 16 male cattle were administered single subcutaneous injections of one of two closantel formulations, at doses of 5 mg/kg bw.
Danish: Farmakokinetisk undersøgelse, hvor 16 stykker hankvæg fik en enkelt subkutan injektion af en af to formuleringer af closantel i en dosering på 5 mg/kg kropsvægt.
English: Using this value, a molecular weight of 359.66, a dose of 10 mg/kg bw, and a body weight of 50 kg, the time needed to ensure a total residue burden equal to a safe number of molecules in 1.5 l milk was calculated to be 359 days.
Danish: Når denne værdi lægges til grund, en molekylvægt på 359,66, en dosis på 10 mg/kg kropsvægt og en kropsvægt på 50 kg, kan den nødvendige tid til opnåelse af en total restkoncentrationsbelastning svarende til et sikkert antal molekyler i 1,5 l mælk beregnes til 359 dage.
English: Plasma closantel concentrations were monitored for up to 1848 hours after administration (GLP study).
Danish: Plasmakoncentrationerne af closantel blev fulgt i op til 1848 timer efter administrationen (GLP-overensstemmende undersøgelse).
English: Residue study in milk following oral administration of triclabendazole to cows around two months before calving.
Danish: Restkoncentrationsundersøgelse i mælk efter oral administration af triclabendazol til køer 2 måneder før kælvning.
English: The remaining 52% of the ADI corresponds to 62 µg of clorsulon residues.
Danish: De resterende 52 % af ADI-værdien svarer til en restkoncentration af clorsulon på 62 µg.
English: Using the longest reported figure of 16.6 days, a molecular weight of 626, a dose of 7.5 mg/kg bw, and a body weight of 50kg, the time needed to ensure a total residue burden equal to a safe number of molecules in 1.5 l milk was calculated to be 272 days which, for the purposes of this referral, can be rounded up to 1 year.
Danish: Hvis den længste angivne tid på 16,6 dage lægges til grund, en molekylvægt på 626, en dosis på 7,5 mg/kg kropsvægt og en kropsvægt på 50 kg, kan den nødvendige tid til opnåelse af en total restkoncentrationsbelastning svarende til et risikofrit antal molekyler i 1,5 l mælk beregnes til 272 dage, som i denne indbringelse rundes op til et år.
English: the CVMP has recommended variations of the marketing authorisations for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as single active substances, and for the triclabendazole-containing veterinary medicinal products administered as pouron (see Annex I) in order to amend the Summaries of Product Characteristics and package leaflets in line with recommended changes in the product information as set out in Annex III.
Danish: anbefalede CVMP ændring af markedsføringstilladelserne for veterinærlægemidler indeholdende clorsulon, closantel, nitroxinil, rafoxanid eller triclabendazol som eneste aktive stof og for pour-on veterinærlægemidler (se bilag I) indeholdende triclabendazol og moxidectin med henblik på, at produktresuméerne og indlægssedlerne ændres i henhold til de anbefalede ændringer i produktinformationen, som fremgår af bilag III.
English: Vanelli S.R.L.
Danish: Rumænien Vanelli S.R.L.
English: The remaining 20% of the ADI corresponds to 60 µg of nitroxinil residues.
Danish: De resterende 20 % af ADI-værdien svarer til en restkoncentration af nitroxinil på 60 µg.
English: It is concluded that closantel administered orally should not be used during the dry period.
Danish: Det konkluderes, at oralt indgivet closantel ikke bør anvendes i goldperioden.
English: • The scope of the referral was to determine whether measures are necessary to ensure that the use during the non-lactating period, of veterinary medicinal products containing flukicidal substances for which maximum residue limits have not been established in milk would not lead to residues in milk that, combined with residues of these flukicidal substances from other foodstuffs, would result in consumer exposure exceeding the exceeding the acceptable daily intake;
Danish: • indbringelsen havde til formål at fastslå, om der er behov for foranstaltninger til undgåelse af, at anvendelse uden for laktationsperioden af veterinærlægemidler indeholdende trematodemidler, som ikke er omfattet af maksimalgrænseværdier for restkoncentrationer i mælk, medfører restkoncentrationer i mælk, som i kombination med restkoncentrationer af sådanne trematodemidler fra andre fødemidler eksponerer forbrugerne for mængder, der overskrider ADIværdien,
English: Indeed, it should be noted that the derivation of a withdrawal period uses established MRLs as the starting point.
Danish: Der gøres opmærksom på, at udgangspunktet for fastsættelse af en tilbageholdelsestid er maksimalgrænseværdier for restkoncentrationer.
English: Pfizer Ltd Ramsgate Road Sandwich Kent
Danish: Ramsgate Road Sandwich
English: It was therefore considered appropriate to apply the marker to total residues ratio of 0.4, established for bovine muscle, to milk as this represented the most conservative marker to total residues ratio established for bovine tissues (marker to total residues ratios in liver and kidney were 0.55 and 0.75, respectively - no marker to total residues ratio was established for fat).
Danish: Det blev derfor anset for hensigtsmæssigt, at forholdet mellem restmarkør og totale restkoncentrationer i muskelvæv fra køer - der er bestemt til 0,4 - anvendes på mælk, da dette udgjorde det mest restriktive skøn over forholdet mellem restmarkør og totale restkoncentrationer i væv fra køer (idet forholdet mellem restmarkør og totale restkoncentrationer i lever og nyrer var henholdsvis 0,55 og 0,75, men ikke var bestemt for fedtvæv).
English: Plasma closantel levels were monitored for up to 1488 hours after administration (GLP study).
Danish: Indholdet af closantel i plasma blev fulgt i op til 1488 timer efter administrationen (GLP-overensstemmende undersøgelse).
English: Calculation of the time needed to ensure a total residue burden equal to a safe number of molecules in 1.5 l milk requires the terminal half-life for the substance to be known.
Danish: Til beregning af den nødvendige tid til opnåelse af en total restkoncentrationsbelastning svarende til et risikofrit antal molekyler i 1,5 l mælk må stoffets terminale halveringstid kendes.
English: Study 1.
Danish: Undersøgelse 1.
English: No radiolabelled data were available for use in determining an appropriate marker residue for use in milk and on which to base a ratio of marker to total residues.
Danish: Der forelå ingen data med radioaktivt mærket stof, som kunne bruges til at vælge en hensigtsmæssig restmarkør i mælk og fastlægge forholdet mellem restmarkøren og de totale restkoncentrationer.
English: Endex Suspensie Triclabendazole Levamisole
Danish: Endex Suspensie Triclabendazol Levamisol
English: Triclabendazole
Danish: Triclabendazol
English: Romania
Danish: RUMÆNIEN
English: No milk residue data are available that would allow empirical determination of a marker residue and a ratio of marker to total residues in milk.
Danish: Der foreligger ingen restkoncentrationsdata for mælk til empirisk bestemmelse af en restmarkør og forholdet mellem koncentrationen af restmarkøren og de totale restkoncentrationer i mælk.
English: Milk concentrations of triclabendazole were measured for up to 20 days after calving (GLP compliant)
Danish: Indholdet af triclabendazol i mælk blev fulgt i op til 20 dage efter kælvning (GLP-overensstemmende undersøgelse).
English: Amendments in the relevant sections of the summary of product characteristics
Danish: Ændringer i de relevante afsnit af produktresuméet
English: Finally, the test for residues of nitroxinil in milk, which the marketing authorisation holder suggested could be used to ensure that residue levels remain below the safe level even following early calvings, has not been taken into account in this evaluation due to the lack of detailed information on the test in question.
Danish: Endelig er der i denne vurdering ikke taget hensyn til den prøve for restkoncentrationer af nitroxinil i mælk, som indehaveren af markedsføringstilladelsen foreslår anvendt til at sikre, at restkoncentrationerne er under det risikofri niveau selv efter tidlig kælvning.
English: Belgium Merial Belgium S.A. Boulevard Sylvain Dupuis 243 B-1070 Bruxelles
Danish: Boulevard Sylvain Dupuis 243 B-1070 Bruxelles BELGIEN
English: Residues of triclabendazole in goats' milk
Danish: Restkoncentrationer af triclabendazol i gedemælk
English: M g in amount safe µ equation 3 in which M = Molar mass (g/mol), A = Avogadro's number = 6.0 * 1023
Danish: M = molarmasse (g/mol), A = Avogadros tal = 6,0 * 1023 Resultatet af ligning 2 afrundes altid til et helt antal dage.
English: Pfizer Hellas AE Mesogeion 243 N.Psichiko 15451 GREECE
Danish: Grækenland Pfizer Hellas AE Mesogeion 243
English: CYPRUS
Danish: Cypern
English: Cyprus
Danish: CYPERN
English: Consequently, it was considered reasonable to use a ratio of marker to total residues of 0.5 for nitroxinil in milk (marker to total residues ratios established for bovine liver, kidney and muscle are 0.04, 0.34 and 1, respectively).
Danish: Det blev derfor fundet rimeligt at anvende et forhold mellem koncentrationerne af restmarkøren og de totale restkoncentrationer på 0,5 for nitroxinil i mælk (i bovin lever, nyre og muskel er forholdet mellem restmarkøren og de totale restkoncentrationer henholdsvis 0,04, 0,34 og