FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this it was estimated that the safe level in milk (16 µg/l) would occur when the plasma concentration of clorsulon is 53 µg/l.
Maltese: Abbażi ta' dan ġie stmat li l-livell sigur filħalib (16 µg/l) iseħħ meta l-konċentrazzjoni ta' Klorsulon fil-plażma tkun ta' 53 µg/l.
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.
Maltese: Bl-użu ta' dan il-valur, piż molekulari ta' 359.66, doża ta' 10 mg/kg tal-piż-tal-ġisem, u piż tal-ġisem ta' 50 kg, iż-żmien meħtieġ biex jiġi żgurat piż residwu totali ugwali għal numru sigur ta' molekuli f'1.5 l ta' ħalib kien ikkalkolat li kien ta' 359 jum.
English: Residue depletion study following a single subcutaneous administration of 10 mg/kg bw nitroxinil to 35 pregnant cows.
Maltese: Studju ta' tnaqqis tar-residwi wara l-għoti uniku ta' 10 mg/kg tal-piż tal-ġisem ta' nitroxinil taħt il-ġilda lil 35 baqra tqila.
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).
Maltese: stabbilit għax-xaħam tal-bovini, għall-ħalib peress li l-ħalib għandu kontenut għoli ta' xaħam u attività metabolika limitata (il-proporzjonijiet tal-markatur għar-residwi totali stabbiliti għall-fwied, il-kliewi u lmuskoli tal-bovini huma ta' 0.10, 0.80 u 1.00, rispettivament).
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.
Maltese: Minn dawn il-251 prodott mediċinali veterinarju, 96 fihom waħda missustanzi msemmija hawn fuq bħala l-unika sustanza attiva u l-155 li fadal huma prodotti ta' kombinazzjoni li fihom it-tieni sustanza attiva mhux flukicidal.
English: Flukicidal substances are anthelmintics which are active against parasites belonging to the class of trematodes.
Maltese: Sustanzi Flukicidal huma antelmintiċi li huma attivi kontra parassiti li jappartjenu għall-klassi ta' trematodes.
English: Closantel Mebendazole
Maltese: Klożantel Mebendazole
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).
Maltese: L-MRLs stabbiliti fil-muskoli, fix-xaħam, fil-fwied u fil-kliewi jwasslu għal konsum massimu teoretiku ta' kuljum ta' residwi ekwivalenti għal 70% tal-ADI (Rapport ta' Sinteżi tas-CVMP, 2001).
English: The longest half-life reported for marker residue was 25 days.
Maltese: L-itwal half-life irrapportata għar-residwu markatur kien ta' 25 jum.
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;
Maltese: • is-CVMP ikkunsidra li l-bilanċ ġenerali tal-benefiċċju-riskju huwa pożittiv għall-prodotti li fihom Klorsulon, Klożantel, nitroxinil, rafoxanide jew Triklabendażol bħala sustanzi attivi uniċi, u għallprodotti mediċinali veterinarji li fihom Triklabendażol u moxidectin li jingħataw bħala sustanza li titferra', soġġett għall-inklużjoni ta' struzzjonijiet adegwati u sentenzi ta' twissija dwar l-użu fuq ilbaqar tal-ħalib fl-informazzjoni dwar il-prodott;
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.
Maltese: Abbażi ta' dan ġie stmat li l-livell sigur fil-ħalib (6 µg/l) iseħħ meta lkonċentrazzjoni ta' rafoxanide fil-plażma tkun ta' 0.18 µg/ml.
English: To calculate the total number of molecules administered the following information is required: the total treatment dose given to the animal; the bodyweight of the animal; the molar weight of the drug substance; and Avogadro's number.
Maltese: Biex jiġi kkalkolat in-numru totali ta' molekuli mogħtija l-informazzjoni li ġejja hija meħtieġa: id-doża totali tal-kura mogħtija lill-annimal; il-piż tal-annimal; il-piż molari tas-sustanza mediċinali; u n-numru ta' Avogadro.
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).
Maltese: Għalhekk kien ikkunsidrat xieraq li jiġi applikat proporzjon tal-markatur għar-residwi totali ta' 0.4, stabbilit għall-muskoli tal-bovini, għall-ħalib peress li dan kien jirrappreżenta l-aktar proporzjon konservattiv tal-markatur għar-residwi totali stabbilit għal tessut talbovini (il-proporzjonijiet tal-markatur għar-residwi totali fil-fwied u fil-kliewi kienu ta' 0.55 u 0.75, rispettivament - ma ġie stabbilit l-ebda proporzjon tal-markatur għar-residwi totali għax-xaħam).
English: The time point at which the 95th percentile of the treated population would have plasma clorsulon concentrations below 53 μg/l with 95% confidence was calculated, using the Time-To-Safe-Concentration (TTSC) method, to be 12 days.
Maltese: Permezz tal-użu talmetodu taż-Żmien Għal Konċentrazzjoni Sigura (TTSC), il-punt fiż-żmien li fih il-95 perċentili talpopolazzjoni kkurata jkollha konċentrazzjonijiet ta' Klorsulon fil-plażma taħt it-53 µg/l b'kunfidenza ta' 95% ġie kkalkolat li kien ta' 12-il jum.
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.
Maltese: Madankollu, nitroxinil ġie stabbilit bħala l-markatur residwu fit-tessuti tal-baqar (Rapport ta' Sinteżi tas-CVMP, 1998), u huwa magħruf li huwa r-residwu ewlieni preżenti fix-xaħam, fil-muskoli, fil-kliewi u fil-plażma.
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).
Maltese: Dejta dwar residwi fil-ħalib u l-plażma tiġi evalwata permezz tal-approċċi deskritti fin-Nota tas-CVMP għall-gwida għad-determinazzjoni tal-perjodi ta' tiżmim għall-ħalib (EMEA/CVMP/473/98-FINALI), blużu tal-approċċ taż-żmien għal konċentrazzjoni sigura (TTSC) meta jkun possibbli (jiġifieri fejn irresidwi fl-annimali kollha jaqgħu taħt il-livell meqjus sigur fil-medda ta' żmien li għalih hemm dejta disponibbli), u bl-użu tal-approċċ tal-konċentrazzjoni sigura għal rigressjoni lineari (SCLR) fejn ilmetodu TTSC ma jkunx xieraq (jiġifieri fejn hemm il-ħtieġa li ssir estrapolazzjoni mid-dejta disponibbli sabiex jiġi ddeterminat il-punt fiż-żmien li fih ir-residwi jaqgħu taħt il-livell ikkunsidrat sigur).
English: Assuming consumption of 1.5 litre of milk per day and a marker to total residues ratio of 0.5, it is concluded that the concentration of nitroxinil in milk that can be considered safe is 20 µg/l.
Maltese: Jekk wieħed jassumi konsum ta' 1.5 litri ta' ħalib kuljum u proporzjon talmarkatur għar-residwi totali ta' 0.5, wieħed jikkonkludi li l-konċentrazzjoni ta' nitroxinil fil-ħalib li tista' titqies sigura hija ta' 20 µg/l.
English: Suspension zum Einggeben für Schafe und Lämmer
Maltese: 75 mg/ml Suspension zum Einggeben für Schafe und Lämmer
English: Based on the data from study 4, the ‘SCLR' (Safe concentrations based on linear regression) method was used to calculate the time point at which the 95th percentile of the treated population would have plasma closantel concentrations below 2250 μg/l with 95% confidence.
Maltese: Abbażi tad-dejta mill-istudju 4, il-metodu "SCLR" (Konċentrazzjonijiet siguri bbażati fuq rigressjoni lineari) intuża biex jiġi kkalkolat il-punt fiż-żmien li fih il-95 perċentili tal-popolazzjoni kkurata jkollha konċentrazzjonijiet ta' Klożantel fil-plażma taħt l-2250 µg/l b'kunfidenza ta' 95%.
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.
Maltese: Abbażi ta' dan ġie stmat li l-livell sigur filħalib (45 µg/l) iseħħ meta l-konċentrazzjoni ta' Klożantel fil-plażma tkun ta' 2250 µg/l.
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.
Maltese: L-eżaminazzjoni mill ġdid kienet tirrigwarda l-emendi rakkomandati tas-sezzjoni 4.11 Perjodu(i) ta' tiżmim tal-SPC għall-prodotti mediċinali veterinarji li fihom nitroxinil li jingħataw lill-baqar.
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.
Maltese: Bl-użu tal-itwal figura rrapportata ta' 24 jum, piż molekulari ta' 663, doża ta' 10 mg/kg tal-piż-tal-ġisem, u piż tal-ġisem ta' 50 kg, iż-żmien meħtieġ biex jiġi żgurat piż residwu totali ugwali għal numru sigur ta' molekuli f'1.5 l ta' ħalib kien ikkalkolat li kien ta' 299 jum.
English: Fasciola hepatica (common name: liver fluke), is the causative agent of fasciolosis, one of the most economically important helminth diseases of livestock worldwide.
Maltese: Fasciola hepatica (isem komuni: parassita tal-fwied), huwa l-aġent li jikkawża fasciolosis, waħda mill-aktar mard ekonomikament importanti tal-bhejjem madwar id-dinja kollha kkawżat minn helminths.
English: Closantel oral
Maltese: Soluzzjoni orali
English: • on the basis of the data provided it was considered that the risk associated with the absence of established MRLs in milk for clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole may present a risk to public health;
Maltese: • abbażi tad-dejta pprovduta kien ikkunsidrat li r-riskju assoċjat man-nuqqas ta' MRLs stabbiliti filħalib għal Klorsulon, Klożantel, nitroxinil, rafoxanide jew Triklabendażol jista' jippreżenta riskju għas-saħħa pubblika;
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).
Maltese: Konsegwentement, kien ikkunsidrat raġonevoli li jintuża proporzjon tal-markatur għar-residwi totali ta' 0.5 għal nitroxinil fil-ħalib (il-proporzjonijiet talmarkatur għar-residwi totali stabbiliti għall-fwied, għall-kliewi u għall-muskoli tal-bovini huma ta' 0.04, 0.34 u 1, rispettivament).
English: Fasinex 10% Triclabendazole 10 g/100ml
Maltese: Fasinex 10% Triklabendażol
English: Pharmacokinetic study in which 4 male and 4 female cattle were administered a single pouron dose of 20 mg/kg bw closantel.
Maltese: Studju farmakokinetiku li fih 4 baqar irġiel u 4 baqar nisa ngħataw doża unika ta' 20 mg/kg tal-piż tal-ġisem ta' Klożantel bħala sustanza li titferra'.
English: Endex 19.5% Triclabendazole Levamisole
Maltese: Endex 19.5% Triklabendażol Levamisole
English: Closamectin 5mg/ml+200 mg/ml Pour on solution for cattle
Maltese: Closamectin 5mg/ml+200 m g/ml Pour on solution for Cattle
English: Closamectin 5mg/ml+200 mg/ml Pour on solution for Cattle
Maltese: Closamectin 5mg/ml+200 m g/ml Pour on solution for cattle
English: 2 Estimated daily consumption according to standard food basket for the calculation of the theoretical maximum daily intake of residues and calculation of maximum residue limits
Maltese: 2 Stima tal-konsum ta' kuljum skont ikel standard għall-kalkolu tal-konsum massimu teoretiku ta' kuljum ta' residwi u l kalkolu ta' limiti massimi ta' residwi għandha l-limitazzjonijiet tagħha, l-approċċ użat għandu l-għan li jipprovdi użu pragmatiku ta' riżorsi limitati.
English: Intramuscular / subcutaneous
Maltese: Klożantel intramuskulari
English: Triclabendazole Ivermectin mg/tablet mg/tablet
Maltese: 500 mg/tab let mg/tablet
English: Flukiver Combi 50 und 75 mg/ml
Maltese: Flukiver Combi 50 und
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perjodu(i) ta' tiżmim
English: Cevamec D Clorsulon Ivermectin subcutaneous Cattle
Maltese: Cevamec D Klorsulon Ivermectin
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).
Maltese: L-MRLs stabbiliti għall-muskoli, għax-xaħam, għall-fwied u għall-kliewi jwasslu għal konsum massimu teoretiku ta' kuljum ta' residwi ekwivalenti għal 48% tal-ADI (CVMP, 2008).
English: However, veterinary medicinal products containing clorsulon administered subcutaneously authorised in the in the Member States (EU/EEA) are all combination products containing ivermectin as second active substance.
Maltese: Madankollu, prodotti mediċinali veterinarji li fihom Klożantel mogħtija permezz ta' sustanza li titferra' u awtorizzati fl-Istati Membri (UE/ŻEE) huma kollha prodotti ta' kombinazzjoni li fihom ivermectin bħala t-tieni sustanza attiva.
English: Ivermectin Clorsulon
Maltese: Ivermectin Klorsulon
English: Milk levels of closantel were measured for up to 84 days post treatment (GCP for animal phase and GLP for analytical phase).
Maltese: Il-livelli ta' Klożantel fil-ħalib ġew imkejla sa 84 jum wara l-kura (PKT għall-fażi tal-annimali u GLP għall-fażi analitika).
English: Fascoverm Closantel
Maltese: Fascoverm Klożantel
English: Pour-on pour-on use
Maltese: Nagħaġ, Mogħoż
English: Biotransformation and excretion study following single oral administration of rafoxanide 131I-rafoxanide to 2 cattle and 2 sheep.
Maltese: Studju ta' bijotrasformazzjoni u ta' eliminazzjoni wara l-għoti orali uniku ta' rafoxanide 131Irafoxanide lil 2 baqar u 2 nagħaġiet.
English: Fasinex 5% Triclabendazole 5 g/100ml
Maltese: Fasinex 5% Triklabendażol
English: It is noted that, in practice, the dry period is generally considerably shorter than 81 days or 12 weeks.
Maltese: Ġie nnotat li, fil-prattika, ġeneralment il-perjodu xott huwa konsiderevolment iqsar minn 81 jum jew 12-il ġimgħa.
English: 5 g/100 ml intramuscular / subcutaneous
Maltese: 5 g/100 ml intramuskulari / taħt il-ġilda
English: This can be done by using empirically derived milk to plasma ratios or, in principle, by using appropriate pharmacokinetic data (as described by Rasmussen, 19661).
Maltese: Dan jista' jsir bl-użu ta' proporzjonijiet derivati b'mod empiriku tal-ħalib għall-plażma jew, fil-prinċipju, bl-użu ta' dejta farmakokinetika xierqa (kif deskritt minn Rasmussen, 19661).
English: Closantel lvermectin
Maltese: Closamectin Klożantel lvermectin
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.
Maltese: Filwaqt li dan il-perjodu ta' sena huwa ferm itwal mill-perjodu ta' 12-il jum stabbilit għal Klorsulon mogħti taħt il-ġilda, għandu jiġi osservat li l-unika forma farmaċewtika identifikata għallgħoti orali li fiha Klorsulon bħala sustanza attiva unika hija bolus, li għaliha l-valur konservattiv awtomatiku huwa meqjus xieraq.
English: On 14 February 2011, the European Commission initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no MRL has been established in milk intended for use in all ruminants producing milk for human consumption.
Maltese: Fl-14 ta' Frar 2011, il-Kummissjoni Ewropea tat bidu għal riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE, kif emendata, għall-prodotti mediċinali veterinarji kollha li fihom sustanzi attivi li jappartjenu għall-klassi ta' flukicides li għalihom l-ebda MRL ma ġie stabbilit fil-ħalib maħsub għall-użu fl-annimali kollha li jixtarru li jipproduċu l-ħalib għall-konsum mill-bniedem.
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.
Maltese: Is-sustanzi flukicidal li għalihom l-MRL ma jkunx ġie stabbilit fil-ħalib u li huma nklużi bħala sustanzi attivi fi prodotti mediċinali veterinarji awtorizzati fl-Istati Membri (UE/ŻEE) huma Klorsulon, Klożantel, nitroxinil, rafoxanide u Triklabendażol.
English: Closantelum Ivermectinum
Maltese: Klożantelum Ivermectinum
English: Endofluke 10 Triclabendazole 100 mg/ml
Maltese: Endofluke 10 Triklabendażol
English: Closantel Ivermectin
Maltese: Klożantel Ivermectin
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.
Maltese: is-CVMP irrakkomanda varjazzjonijiet għall-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji li fihom Klorsulon, Klożantel, nitroxinil, rafoxanide jew Triklabendażol bħala sustanzi attivi uniċi, u għall-prodotti mediċinali veterinarji li fihom Triklabendażol li jingħataw bħala sustanza li titferra' (ara Anness I) sabiex jiġu emendati s-Sommarji tal-Karatteristiċi tal-Prodott u lfuljetti ta' tagħrif skont il-bidliet irrakkomandati fl-informazzjoni dwar il-prodott kif stabbilit flAnness
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).
Maltese: Madankollu, għal prodotti ta' kombinazzjoni li jingħataw bħala sustanza li titferra' li għalihom ilkonklużjoni fir-rigward tas-sustanza flukicidal Triklabendażol hija li ma jistgħux jintużaw fuq l-annimali tal-ħalib ta' kwalunkwe età, din il-konklużjoni, li hija l-agħar każ, tapplika għall-prodotti kollha ta' kombinazzjoni li jingħataw bħala sustanza li titferra' li fihom Triklabendażol (jiġifieri Triklabendażol u moxidectin).
English: Fascinex 100 Triclabendazole 100 mg/ml
Maltese: Fascinex 100 Triklabendażol
English: Ito, S., Lee, A. (2003) Drug excretion into breast milk- overview.
Maltese: Ito, S., Lee, A.
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.
Maltese: Peress li r-rata ta' eliminazzjoni hija ugwali għall-kompartimenti kollha tal-ġisem matul il-fażi terminali ta' eliminazzjoni, iż-żmien meħtieġ biex mediċina tiġi eliminata mill-ġisem jista' jiġi stmat billi tiġi applikata l-eliminazzjoni tal-half-life terminali għas-sustanza man-numru totali ta' molekuli mogħtija.
English: 5 g/100 ml intramuscular / subcutaneous /
Maltese: 5 g/100 ml intramuskulari / taħt il-ġilda /
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.
Maltese: Wara li kkunsidra l-pakkett globali ta' dejta sottomessa s-CVMP ikkonkluda li l-bilanċ tal-benefiċċjuriskju għall-prodotti mediċinali veterinarji li fihom Klorsulon, Klożantel, nitroxinil, rafoxanide jew Triklabendażol bħala sustanzi attivi uniċi (ara Anness I) kien pożittiv, sakemm l-istruzzjonijiet adegwati dwar l-użu fuq l-annimali tal-ħalib jiġu inklużi fis-sezzjoni 4.11 Perjodu(i) ta' tiżmim tal-SPC talprodotti rilevanti abbażi tal-meded ta' żmien li jidhru fit-tabella hawn fuq.
English: Plasma radioactivity and closantel levels were monitored for up to 42 days after administration (non GLP).
Maltese: Irradjuattività fil-plażma u l-livelli ta' Klożantel ġew immonitorjati sa 42 jum wara l-għoti (mhux GLP).
English: Pour-on pour-on
Maltese: Mogħoż
English: Virbamec super Clorsulon Ivermectin subcutaneous Cattle
Maltese: Virbamec super Klorsulon Ivermectin
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.
Maltese: Jekk wieħed jassumi konsum ta' 1.5 litri ta' ħalib kuljum u proporzjon tal-markatur għar-residwi totali ta' 0.4, jiġi konkluż li l-konċentrazzjoni ta' Klorsulon fil-ħalib li tista' titqies bħala sigura hija ta' 16 µg/l.
English: G. For products listed in Annex I containing rafoxanide as sole active substance and administered orally to cattle:
Maltese: Għall-prodotti elenkati fl-Anness 1 li fihom Klorsulon bħala l-unika sustanza attiva u li jingħataw b'mod orali lill-baqar:
English: However, as closantel was established as the marker residue in cattle tissues (CVMP Summary Report, 1996) and as the substance is known to undergo only limited metabolism in vivo, closantel was also considered to be an appropriate marker residue for use in milk.
Maltese: Madankollu, peress li Klożantel ġie stabbilit bħala r-residwu markatur fit-tessuti tal-baqar (Rapport ta' Sinteżi tas-CVMP, 1996) u peress li s-sustanza hija magħrufa li tgħaddi biss minn metaboliżmu limitat in vivo, Klożantel kien ikkunsidrat ukoll bħala residwu markatur adattat għall-użu fil-ħalib.
English: Assuming consumption of 1.5 litre of milk per day and a marker to total residues ratio of 0.7, it is concluded that the concentration of closantel in milk that can be considered safe is 45 µg/l.
Maltese: Jekk wieħed jassumi konsum ta' 1.5 litri ta' ħalib kuljum u proporzjon talmarkatur għar-residwi totali ta' 0.7, wieħed jikkonkludi li l-konċentrazzjoni ta' Klożantel fil-ħalib li tista' titqies sigura hija ta' 45 µg/l.
English: MRLs established in muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 80% of the ADI.
Maltese: L-MRLs stabbiliti fil-muskoli, fix-xaħam, fil-fwied u fil-kliewi jwasslu għal konsum massimu teoretiku ta' kuljum ta' residwi ekwivalenti għal 80% tal-ADI.