FrancophonIA/ELRC3.0 huggingface dataset:
English: The remaining 30% of the ADI corresponds to 27 µg triclabendazole residues.
Danish: De resterende 30 % af ADI-værdien svarer til en restkoncentration af triclabendazol på 27 µg.
English: Based on this it was estimated that the safe level in milk (6 µg/l) would occur when the plasma concentration of rafoxanide is 0.18 µg/ml.
Danish: Herudfra kan man beregne, at det risikofri indhold i mælk (6 µg/l) indtræder ved en plasmakoncentration af rafoxanid på 0,18 µg/ml.
English: Intramuscular / subcutaneous
Danish: Closantel intramuskulær/ subkutan
English: M. For products listed in Annex I containing triclabendazole and moxidectin as active substances and administered as pour-on to cattle:
Danish: M. For de i bilag I opførte lægemidler, der indeholder triclabendazol og moxidectin som de aktive stoffer og administreres som pour-on til kvæg:
English: Grounds for amendment of the summaries of product characteristics and package leaflets
Danish: Begrundelse for ændringen af produktresuméerne og indlægssedlerne
English: Triclabendazole Levamisole
Danish: Triclabendazol Levamisol
English: Calculating the time needed to ensure a total residue burden equal to a safe number of molecules in 1.5 l milk
Danish: Beregning af den nødvendige tid til sikring af en total restkoncentrationsbelastning svarende til et risikofrit antal molekyler i 1,5 l mælk
English: Do not use during 2nd half of gestation period
Danish: Må ikke anvendes i sidste halvdel af drægtighedsperioden
English: It is concluded that use of nitroxinil-containing products administered by the subcutaneous route should take place before the last 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 subkutan anvendelse af nitroxinilholdige lægemidler bør ske før det sidste trimester af drægtighedsperioden for at sikre, at restkoncentrationerne i mælk ikke medfører en større eksponering for restkoncentrationer end svarende til ADI-værdien.
English: Using the longest reported figure of 24 days, a molecular weight of 663, 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 299 days.
Danish: Når den længste angivne tid på 24 dage lægges til grund, en molekylvægt på 663, en dosis på 10 mg/kg kropsvægt og en kropsvægt på 50 kg, kan tiden til opnåelse af en total restkoncentrationsbelastning svarende til et risikofrit antal molekyler i 1,5 l mælk beregnes til 299 dage.
English: Study 5.
Danish: Undersøgelse 5.
English: Furthermore, the pharmacokinetic data (terminal elimination halflife) required to calculate the time needed to ensure a total residue burden equal to a safe number of molecules in 1.5 l milk was not available.
Danish: Endvidere forelå der ikke de nødvendige farmakokinetiske data (terminal eliminationshalveringstid) til beregning af tiden til opnåelse af en total restkoncentrationsbelastning, der svarer til et risikofrit antal molekyler i 1,5 l mælk.
English: MRLs established in muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 70% of the ADI (CVMP Summary Report, 2001).
Danish: De fastlagte maksimalgrænseværdier for restkoncentrationer i muskel, fedtvæv, lever og nyre fører til en teoretisk maksimal daglig indtagelse af restkoncentrationer svarende til 70 % af ADI-værdien (CVMP Summary Report, 2001).
English: Belgium Janssen Pharmaceutica N.V. 30 Turnhoutseweg
Danish: Grækenland Janssen Pharmaceutica N.V.
English: Supaverm Closantel Mebendazole
Danish: Supaverm Closantel Mebendazol
English: No suitable residue data in milk from ewes treated in the dry period are available, no information that would allow the establishment of a ratio of marker to total residues are available and data that would allow the establishment of a milk to plasma ratio in sheep are not available.
Danish: Der foreligger ingen passende restkoncentrationsdata for får behandlet i goldperioden, ingen oplysninger til fastlæggelse af koncentrationsforholdet mellem restmarkør og totale restkoncentrationer, og ingen data til bestemmelse af mælk/plasma koncentrationsforholdet hos får.
English: Fenafluke 5% Rafoxanide Fenbendazole
Danish: Fenafluke 5 % Rafoxanid Fenbendazol
English: The remaining 25% of the ADI corresponds to 30 µg rafoxanide residues.
Danish: De resterende 25 % af ADI-værdierne svarer til en restkoncentration af rafoxanid på 30 µg.
English: Austria
Danish: ØSTRIG
English: AUSTRIA
Danish: Østrig
English: Pharmacokinetic study in which 4 male and 4 female cattle were administered a single pouron dose of 20 mg/kg bw closantel.
Danish: Farmakokinetisk undersøgelse, hvor fire stykker hankvæg og fire stykker hunkvæg fik en enkeltdosis af closantel pour-on på 20 mg/kg kropsvægt.
English: Study 2.
Danish: Undersøgelse 2.
English: 08041 Barcelona SPAIN
Danish: 08041 Barcelona SPANIEN
English: The equation can be converted to find the time needed to ensure a total residue burden in the body equivalent to the part of the ADI available to accommodate residues in 1.5 l milk (taking into account the maximum theoretical exposure to residues calculated from the existing tissue MRLs):
Danish: Ligningen kan omformes for at udlede den tid, det kræver at sikre, at den totale belastning med restkoncentrationer i kroppen svarer til den del af ADI-værdien, der er til rådighed til restkoncentrationer i 1,5 l mælk.
English: Fasinex 100 10%(w/v) Oral Suspension for Cattle and Sheep
Danish: 10 %(w/v) Oral Suspension for Cattle and Sheep
English: Minimum safe time span
Danish: Intet sikkert tidsinterval
English: Study 4.
Danish: Undersøgelse 4.
English: No suitable residue data in milk from ewes treated in the dry period are available, and data that would allow the establishment of a milk to plasma ratio in sheep are not available.
Danish: Der foreligger ikke egnede restkoncentrationsdata for får behandlet i goldperioden, og ingen oplysninger til fastlæggelse af koncentrationsforholdet mellem mælk og plasma hos får.
English: In the absence of these data, the time needed to ensure a total residue burden equal to a safe number of molecules in 1.5 l milk was calculated.
Danish: I mangel af sådanne data beregnedes tiden til opnåelse af en total restkoncentrationsbelastning svarende til et risikofrit antal molekyler i 1,5 l mælk.
English: In those cases where appropriate information on residue levels in milk or plasma are not available, a more stringent pharmacokinetic approach can be employed to calculate the time needed to allow elimination of a sufficient amount of residues to ensure that the quantity of residues remaining in the animal's body is such that if all remaining residues were present in 1.5 l milk2, the consumer's overall exposure to residues (including residues present in other food commodities) would not be above the ADI.
Danish: Herved beregnes den tid, der kræves til udskillelse af en mængde restkoncentrationer, der sikrer, at hvis alle de tilbageværende restkoncentrationer i dyrets krop var til stede i 1,5 l mælk2, ville den samlede eksponering af forbrugeren (herunder restkoncentrationer i andre fødevarer) ikke overstige ADI-værdien.
English: Study 6.
Danish: Undersøgelse 6.
English: MRLs established muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 48% of the ADI (CVMP, 2008).
Danish: De fastsatte maksimalgrænseværdier for restkoncentrationer i muskel, fedtvæv, lever og nyrer fører til en teoretisk maksimal daglig indtagelse af restkoncentrationer svarende til 48 % af ADI-værdien (CVMP, 2008).
English: Norofas Pour on Closantel Ivermectine
Danish: Norofas Pour on Closantel Ivermectin
English: The amount and quality of available data are not comparable with that which would normally form the basis for the establishment of MRLs or withdrawal periods and as a result, the recommendations made are general and conservative, and are not product specific - no distinction is made to account for formulation or strength differences, or for dosage differences.
Danish: De foreliggende data kan i omfang og kvalitet ikke sidestilles med, hvad der normalt er grundlag for fastsættelse af maksimalgrænseværdier for restkoncentrationer eller tilbageholdelsestider.
English: MRLs established in muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 75 % of the ADI (CVMP, 2001).
Danish: Maksimalgrænseværdier for restkoncentrationer i muskel, fedtvæv, lever og nyre fører til en teoretisk maksimal daglig indtagelse af restkoncentrationer svarende til 75 % af ADI-værdien (CVMP, 2001).
English: Study 3.
Danish: Undersøgelse 3.
English: Defining a safe concentration for clorsulon in milk - cattle
Danish: Fastlæggelse af en sikker koncentration af clorsulon i mælk - kvæg
English: Amendments in the relevant sections of the summary of product characteristics and package leaflet
Danish: Ændringer i de relevante afsnit af produktresuméet og indlægssedlen
English: No milk residue data are available following treatment of dairy animals with clorsulon in the dry period.
Danish: Der foreligger ingen restkoncentrationsdata for mælkeproducerende dyr efter behandling med clorsulon i goldperioden.
English: 08013 Barcelona SPAIN
Danish: 08013 Barcelona SPANIEN
English: Residues of nitroxinil in milk following subcutaneous administration to sheep and goats
Danish: Restkoncentrationer af nitroxinil i mælk efter subkutan administration - får og geder
English: Cattle, Sheep, Goats
Danish: Kvæg, får, geder
English: Endex 8,57% Triclabendazole Levamisole
Danish: Endex 8,57 % Triclabendazol Levamisol
English: Triclabendazole Goats oral
Danish: Triclabendazol oral
English: 5 g/100ml intramuscular / subcutaneous
Danish: 5 g/100 ml intramuskulær/ subkutan
English: Curafluke 10% Rafoxanide Fenbendazole
Danish: Curafluke 10 % Rafoxanid Fenbendazol
English: Amendments in the relevant sections of the package leaflet:
Danish: Ændringer i de relevante afsnit af indlægssedlen
English: Target species
Danish: Måldyreart er
English: Belgium Novartis Consumer Health B.V. Claudius Prinsenlaan 142
Danish: Nederlandene Novartis Consumer Health B.V.
English: Residue data in milk and plasma are evaluated using the approaches described in the CVMP Note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98-FINAL), using the time to safe concentration (TTSC) approach where possible (i.e. where residues in all animals fall below the level considered safe within the time span for which data are available), and using the safe concentration for linear regression (SCLR) approach where the TTSC method is not appropriate (i.e. where it is necessary to extrapolate from the available data in order to determine the time point at which residues fall below the level considered safe).
Danish: Når TTSC-metoden ikke er egnet (dvs. når der må ekstrapoleres fra de foreliggende data for at fastlægge det tidspunkt, hvor restkoncentrationerne er under det niveau, der anses for risikofrit), benyttes “safe concentration for linear regression (SCLR)"-metoden (risikofri koncentration ved lineær regression).
English: No data on residues in milk following oral administration were available and no data that would allow extrapolation of residue concentrations from plasma concentrations following oral use were available.
Danish: Der forelå ingen data om restkoncentrationer i mælk efter oral administration, og ingen data, der tillod at ekstrapolere restkoncentrationerne fra plasmakoncentrationerne efter oral brug.
English: Defining a safe concentration for closantel in milk - cattle
Danish: Fastlæggelse af en sikker koncentration af closantel i mælk - kvæg
English: Fascinex 240 Triclabendazole 240 mg/ml
Danish: Fascinex 240 Triclabendazol
English: Oral solution oral
Danish: Oral opløsning oral
English: Endex 19.5% Triclabendazole Levamisole
Danish: Endex 19.5 % Triclabendazol Levamisol
English: However for combination products administered as pour-on for which the conclusion with regard to the flukicidal substance triclabendazole is that it cannot be used in dairy animals of any age, this conclusion, being the worst case scenario, applies to all pour-on combination products containing triclabendazole (i.e. triclabendazole and moxidectin).
Danish: Denne konklusion svarer til værste tilfælde og gælder for alle pour-on kombinationslægemidler indeholdende triclabendazol (dvs. triclabendazol og moxidectin).
English: No milk residue data are available following treatment of dairy animals with rafoxanide in the dry period.
Danish: Der foreligger ingen restkoncentrationsdata for mælkeproducerende dyr efter behandling med rafoxanid i goldperioden.
English: Curafluke 5% Rafoxanide Fenbendazole
Danish: Curafluke 5 % Rafoxanid Fenbendazol
English: No data on residues in milk following subcutaneous administration in these species were available and no data that would allow extrapolation of residue concentrations from plasma concentrations following use in these species were available.
Danish: Der forelå ingen data om restkoncentrationer i mælk efter subkutan administration til disse arter, og ingen data til ekstrapolering af restkoncentrationerne fra plasmakoncentrationerne efter anvendelse hos disse arter.
English: No data on residues in goats' milk were available and no data that would allow extrapolation of residue concentrations from plasma concentrations were available.
Danish: Der forelå ingen data om restkoncentrationer i gedemælk, og ingen data til ekstrapolering af restkoncentrationerne fra plasmakoncentrationerne.
English: Defining a safe concentration for triclabendazole in milk - sheep
Danish: Bestemmelse af en sikker koncentration af triclabendazol i mælk - får
English: Do not use during the last trimester of pregnancy in heifers which are intended to produce milk for human consumption.
Danish: Må ikke anvendes i sidste trimester af drægtighedsperioden hos kvier, der er bestemt til mælkeproduktion til menneskeligt konsum.
English: Endex 8.75% Triclabendazole Levamisole
Danish: Endex 8.75 % Triclabendazol Levamisol
English: A. For products listed in Annex I containing clorsulon as sole active substance and administered orally to cattle:
Danish: A. For de i bilag I opførte lægemidler, der indeholder clorsulon som eneste aktive stof og administreres oralt til kvæg:
English: Triclabendazole 5 g/100 ml
Danish: Triclabendazol Levamisol g/100 ml 7,5 g/100 ml
English: Defining a safe concentration for rafoxanide in milk - cattle
Danish: Bestemmelse af en sikker koncentration af rafoxanid i mælk - kvæg
English: F. For products listed in Annex I containing nitoxinil as sole active substance and administered subcutaneously to sheep and goats:
Danish: F. For de i bilag I opførte lægemidler, der indeholder nitroxinil som eneste aktive stof og administreres subkutant til får og geder:
English: Suspension zum Einggeben für Schafe und Lämmer
Danish: 75 mg/ml Suspension zum Einggeben für Schafe und Lämmer
English: Fasinex 24% Triclabendazole 240 mg/ml
Danish: Fasinex 24 % Triclabendazol
English: Do not use in cattle of any age intended to produce milk for human consumption.
Danish: Må ikke anvendes hos kvæg, der er bestemt til mælkeproduktion til menneskeligt konsum, uanset dyrets alder.
English: Defining a safe concentration for nitroxinil in milk - cattle
Danish: Fastlæggelse af en risikofri koncentration af nitroxinil i mælk - kvæg
English: D. For products listed in Annex I containing closantel as sole active substance and administered subcutaneously or orally to sheep:
Danish: D. For de i bilag I opførte lægemidler, der indeholder closantel som eneste aktive stof og administreres subkutant eller oralt til får:
English: Defining a safe concentration for rafoxanide in milk - sheep
Danish: Bestemmelse af en sikker koncentration af rafoxanid i mælk - får
English: Assuming consumption of 1.5 litre of milk per day and a marker to total residues ratio of 0.4, it is concluded that the concentration of clorsulon in milk that can be considered safe is 16 µg/l.
Danish: Under forudsætning af en daglig indtagelse af mælk på 1,5 l og et forhold mellem restmarkør og totale restkoncentrationer på 0,4 kan det konkluderes, at den koncentration af clorsulon i mælk, der kan anses for risikofri, er 16 µg/l.
English: Bimectin Fluke Clorsulon Ivermectin subcutaneous Cattle
Danish: Bimectin Fluke Clorsulon Ivermectin
English: No data on residues in milk following subcutaneous administration were available and no data that would allow extrapolation of residue concentrations from plasma concentrations following subcutaneous use.
Danish: Der forelå ingen data om restkoncentrationer i mælk efter subkutan administration, og ingen data til ekstrapolering af restkoncentrationerne fra plasmakoncentrationerne efter subkutan brug.
English: Do not use during the second half of pregnancy in heifers which are intended to produce milk for human consumption.
Danish: Må ikke anvendes i anden halvdel af drægtighedsperioden hos kvier, der er bestemt til mælkeproduktion til menneskeligt konsum.
English: Closamectin 5mg/ml+200 mg/ml Pour on solution for cattle
Danish: Closamectin 5mg/ml+200 m g/ml Pour on solution for Cattle
English: Closamectin 5mg/ml+200 mg/ml Pour on solution for Cattle
Danish: Closamectin 5mg/ml+200 m g/ml Pour on solution for cattle
English: Belgium Virbac de Portugal Laboratórios LDA
Danish: Nederlandene Virbac de Portugal Laboratorios LDA
English: Chanectin Super Clorsulon Ivermectin subcutaneous Cattle
Danish: Chanectin Super Clorsulon Ivermectin
English: Although 12 days was considered sufficient to allow for the depletion of residues of clorsulon 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 12 days would also allow residues of ivermectin to deplete to safe levels.
Danish: For ivermectin kunne det imidlertid ikke konkluderes, om 12 dage er tilstrækkeligt til nedbrydelse af restkoncentrationerne til et risikofrit niveau, da ivermectin ikke er omfattet af indbringelsen.
English: I. For products listed in Annex I containing rafoxanide as sole active substance and administered orally to sheep:
Danish: I. For de i bilag I opførte lægemidler, der indeholder rafoxanid som eneste aktive stof og administreres oralt til får:
English: Assuming consumption of 1.5 l of milk per day and a marker to total residues ratio of 0.6, it is concluded that the concentration of triclabendazole in milk that can be considered safe is 10 µg/l.
Danish: Under forudsætning af en daglig indtagelse af mælk på 1,5 l og et forhold mellem restmarkøren og de totale restkoncentrationer på 0,6 kan det konkluderes, at den koncentration af triclabendazol i mælk, der kan anses for risikofri, er 10 µg/l.
English: Residues of closantel in milk following oral administration - cattle
Danish: Restkoncentrationer af closantel i mælk efter oral administration - kvæg
English: Residues of clorsulon in milk following oral administration - cattle
Danish: Restkoncentrationer af clorsulon i mælk efter oral administration - kvæg
English: Residues of triclabendazole in milk following oral administration - cattle
Danish: Restkoncentrationer af triclabendazol i mælk efter oral administration - kvæg
English: E. For products listed in Annex I containing nitoxinil as sole active substance and administered subcutaneously to cattle:
Danish: E. For de i bilag I opførte lægemidler, der indeholder nitroxinil som eneste aktive stof og administreres subkutant til kvæg:
English: MRLs established in muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 94.4% of the ADI.
Danish: På grundlag af maksimalgrænseværdierne for restkoncentrationer i muskel, lever og nyre kan den teoretiske maksimale daglige indtagelse af restkoncentrationer beregnes til at udgøre 94,4 % af ADIværdien.
English: Flukiver Combi 50 und 75 mg/ml
Danish: Flukiver Combi 50 und
English: Not authorised for use in animals producing milk for human consumption including during the dry period.
Danish: Ikke godkendt til anvendelse hos dyr, der producerer mælk til menneskeligt konsum, herunder i goldperioden.
English: Orafluke 10% Rafoxanide Fenbendazole
Danish: Orafluke 10 % Rafoxanid Fenbendazol
English: Sheep, Goats
Danish: Får, Geder
English: Residues of clorsulon in milk following subcutaneous administration - cattle
Danish: Restkoncentrationer af clorsulon i mælk efter subkutan administration - kvæg
English: It is therefore considered that the only acceptable use of nitroxinil in sheep and goats intended for production of milk for human consumption would involve administration to young animals before the first pregnancy and at least 1 year before the first lambing/kidding.
Danish: Udvalget finder derfor, at den eneste acceptable anvendelse af nitroxinil til får og geder, der producerer mælk til menneskeligt konsum, er anvendelse til unge dyr før første drægtighedsperiode og mindst et år før første læmning.
English: Assuming consumption of 1.5 l of milk per day and a marker to total residues ratio of 0.3, it is concluded that the concentration of rafoxanide in milk that can be considered safe is 6 µg/l.
Danish: Under forudsætning af en daglig indtagelse af mælk på 1,5 l og et forhold mellem koncentrationerne af restmarkøren og de totale restkoncentrationer på 0,3 kan det konkluderes, at den koncentration af rafoxanid i mælk, der kan anses for risikofri, er 6 µg/l.
English: Residues of triclabendazole in milk following pour-on administration - cattle
Danish: Restkoncentrationer af triclabendazol i mælk efter administration af pour-on - kvæg
English: Residues of closantel in milk following subcutaneous administration - cattle
Danish: Restkoncentrationer af closantel i mælk efter subkutan administration - kvæg
English: H. For products listed in Annex I containing rafoxanide as sole active substance and administered subcutaneously to cattle:
Danish: H. For de i bilag I opførte lægemidler, der indeholder rafoxanid som eneste aktive stof og administreres subkutant til kvæg:
English: C. For products listed in Annex I containing closantel as sole active substance and administered subcutaneously to cattle:
Danish: C. For de i bilag I opførte lægemidler, der indeholder closantel som eneste aktive stof og administreres subkutant til kvæg:
English: Fasinex 10% Triclabendazole 10 g/100ml
Danish: Fasinex 10 % Triclabendazol
English: (study 4), and as indicated above, the closantel concentration in milk can be considered safe when the level in plasma is below 2250 μg/l.
Danish: Derimod foreligger der data om plasmakoncentrationerne af closantel efter administration af pour-on (undersøgelse 4), og som nævnt kan koncentrationen af closantel i mælk anses for risikofri, når koncentrationen i plasma er under 2 250 μg/l.
English: G. For products listed in Annex I containing rafoxanide as sole active substance and administered orally to cattle:
Danish: G. For de i bilag I opførte lægemidler, der indeholder rafoxanid som eneste aktive stof og administreres oralt til kvæg:
English: J. For products listed in Annex I containing triclabendazole as sole active and administered orally to cattle:
Danish: J. For de i bilag I opførte lægemidler, der indeholder triclabendazol som eneste aktive stof og administreres oralt til kvæg:
English: Residues of rafoxanide in milk following subcutaneous administration - cattle
Danish: Restkoncentrationer af rafoxanid i mælk efter subkutan administration - kvæg
English: Residues of rafoxanide in milk following oral administration - cattle
Danish: Restkoncentrationer af rafoxanid i mælk efter oral administration - kvæg
English: Residues of nitroxinil in milk following subcutaneous administration to cattle
Danish: Restkoncentrationer af nitroxinil i mælk efter subkutan administration - kvæg
English: B. For products listed in Annex I containing closantel as sole active substance and administered orally to cattle:
Danish: B. For de i bilag I opførte lægemidler, der indeholder closantel som eneste aktive stof og administreres oralt til kvæg: