natgillin/translations-raw huggingface dataset:
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.
Sledi zaključek, da se morajo zdravila z rafoksanidom dajati peroralno v prvem ali drugem trimesečju (ne v tretjem trimesečju) brejosti, da koncentracije ostankov v mleku ne privedejo do skupne izpostavljenosti ostankom, ki bi presegla vrednost ADI.
The remaining 5.6% of the ADI corresponds to 100 µg of closantel residues.
Preostalih 5,6 % vrednosti ADI ustreza 100 µg ostankov klozantela.
Fasinex 100 10%(w/v) Oral Suspension for Cattle and Sheep
Fasinex 100 10%(w/v) Oral Suspension for Cattle and Sheep triklabendazol govedo, ovce
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).
Zato je bilo primerno za mleko uporabiti razmerje označevalca proti skupnim ostankom 0,4, ki je določeno za mišice govedi, saj je to najbolj konservativno ugotovljeno razmerje označevalca proti skupnim ostankom pri govedi (razmerje označevalca proti skupnim ostankom v jetrih je 0,55, v ledvicah 0,75, za maščobo pa ni določenega razmerja).
Belgium Janssen Pharmaceutica N.V. 30 Turnhoutseweg
Nizozemska Janssen Pharmaceutica N.V.
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.
Izračun časa, potrebnega, da je skupno breme ostankov enako varnemu številu molekul v 1,5 l mleka, zahteva znano razpolovno dobo končnega izločanja.
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.
Odbor je ob upoštevanju vseh predloženih podatkov zaključil, da je razmerje med tveganji in koristmi za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo klorsulon, klozantel, nitroksinil, rafoksanid ali triklabendazol kot edino zdravilno učinkovino (glejte Prilogo I), pozitivno pod pogojem, da se v poglavje 4.11 Karenca v povzetku glavnih značilnosti zadevnih zdravil vključi primerno navodilo za uporabo pri molznicah glede na časovne presledke iz zgornje preglednice.
As the scope of the referral was restricted to flukicidal substances only, the second active substance in the combination products was not evaluated.
Ker je bil obseg napotitve omejen samo na snovi proti metljajem, druga zdravilna učinkovina v kombiniranih zdravilih ni bila ovrednotena.
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.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je bil naprošen za mnenje o potrebnosti ukrepov, s katerimi se zagotovi, da uporaba zdravil za uporabo v veterinarski medicini, ki vsebujejo zdravilne učinkovine proti metljajem, za katere ni bila določena mejna vrednost ostankov v mleku, zunaj obdobja laktacije ne povzroči ostankov v mleku, ki bi v kombinaciji z ostanki teh snovi proti metljajem iz drugih živil privedle do izpostavljenosti potrošnikov, ki presega vrednost ADI.
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.
Sledi zaključek, da se morajo peroralna zdravila s triklabendazolom dajati v prvem ali drugem trimesečju (ne v tretjem trimesečju) brejosti.
Belgium Merial Belgium S.A. Boulevard Sylvain Dupuis 243 B-1070 Bruxelles
Boulevard Sylvain Dupuis 243 B-1070 BruxellesBELGIJA
The Committee therefore calculated minimum time spans that should elapse between administration of these substances and calving or lambing/kidding for each substance, species and route of administration.
Odbor je zato za vsako snov, živalsko vrsto in pot uporabe izračunal najkrajši časovni presledek med uporabo snovi in kotitvijo.
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.
Poleg tega uporaba farmakokinetičnega difuzijskega modela na podlagi vrednosti pKa in vezave ostankov triklabendazola, ki predstavljajo označevalni ostanek, na beljakovine ni mogoča.
To determine whether residues in milk would result in overall exposure to residues over the ADI it is necessary to know what portion of the ADI is available to accommodate residues in milk (i.e., what portion of the ADI is not already accounted for by exposure to residues present in other food commodities), and the concentration of residues in milk at relevant time points.
Da se ugotovi, ali ostanki v mleku privedejo do skupne izpostavljenosti, ki presega vrednost ADI, je treba poznati delež vrednosti ADI, ki je razpoložljiv za ostanke v mleku (tj. kakšen delež vrednosti ADI
Flukiver 50 mg/ml solução injectável para bovinos e ovinos
Flukiver 50 mg/ml solução injectável para bovinos e ovinos klozantel govedo, ovce
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.
V študiji so bile opažene številne pomanjkljivosti, med drugim ni bila opravljena statistična analiza študije izločanja ostankov iz mleka z rezultati, v katerih ni bila upoštevana variabilnost med živalmi.
Residue depletion study in plasma following single oral administrations of one of two formulations of 7.5 mg/kg bw rafoxanide to 6 cattle and 6 sheep.
Študija izločanja ostankov iz plazme 6 krav in 6 ovac po enem peroralnem odmerku rafoksanida 7,5 mg/kg TM iz dveh formulacij.
Janssen Pharmaceutica N.V. 30 Turnhoutseweg B-2340 Beerse BELGIUM
30 Turnhoutseweg B-2340 Beerse BELGIJA
Plasma closantel concentrations were monitored for up to 1848 hours after administration (GLP study).
Plazemske ravni klozantela so spremljali do 1848 ur po odmerjanju (GLP študija).
Pfizer Hellas AE Mesogeion 243 N.Psichiko 15451 GREECE
Pfizer Hellas AE Mesogeion 243
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.
Zadevna poglavja navodil za uporabo zdravil, ki so vključena v napotitev, je treba spremeniti z upoštevanjem priporočil za poglavje 4.11 Karenca povzetka glavnih značilnosti zdravila.
Triclaben 100 mg/ml perorální suspenze pro skot
Triclaben 100 mg/ml perorální suspenze pro skot triklabendazol
The remaining 20% of the ADI corresponds to 60 µg of nitroxinil residues.
Preostalih 20 % vrednosti ADI ustreza 60 µg ostankov nitroksinila.
Triclabendazole Ivermectin mg/tablet mg/tablet
Distol triklabendazol ivermektin mg/tablet mg/tablet tablete govedo, ovce
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.
Z metodo „CLR“ (varne koncentracije na podlagi linearne regresije) je bila na podatkih iz 4. študije izračunana časovna točka, ko bi imel 95. percentil zdravljene populacije s 95-odstotnim zaupanjem koncentracijo klozantela v plazmi 2250 µg/l.
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.
Če uporabimo največjo objavljeno številko 24 dni, molekulsko maso 663, odmerek 10 mg/kg TM in telesno maso 50 kg, je izračunani čas, potreben, da je skupno breme ostankov enako varnemu številu molekul v 1,5 l mleka, 299 dni.
Calculating the time needed to ensure a total residue burden equal to a safe number of molecules in 1.5 l milk
Izračun časa, potrebnega, da je skupno breme ostankov enako varnemu številu molekul v 1,5 l mleka
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.
Študija izločanja ostankov na 18 brejih kravah po enem dajanju kožnega poliva triklabendazola 60 dni pred pričakovano telitvijo.
It is concluded that triclabendazole administered topically as pour-on should not be used in dairy animals.
Sledi zaključek, da se triklabendazol v obliki kožnega poliva ne sme uporabljati pri molznicah.
Duotech Oral Suspension for Sheep
Duotech Oral Suspension for Sheep klozantel oksfendazol
The remaining 52% of the ADI corresponds to 62 µg of clorsulon residues.
Preostalih 52 % vrednosti ADI ustreza 62 µg ostankov klorsulona.
The remaining 25% of the ADI corresponds to 30 µg rafoxanide residues.
Preostalih 25 % vrednosti ADI ustreza 30 µg ostankov rafoksanida.
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).
Zato je bilo primerno za nitroksinil v mleku uporabiti razmerje označevalca proti skupnim ostankom 0,5 (razmerje označevalca proti skupnim ostankom je pri govedu v jetrih 0,04, v ledvicah 0,34 in v mišicah pa 1).
Study 5.
5. študija.
Furthermore, the pharmacokinetic data (terminal elimination half-life) 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.
Poleg tega niso bili na voljo farmakokinetični podatki (razpolovna doba končnega izločanja) za izračun časa, potrebnega, da je skupno breme ostankov enako varnemu številu molekul v 1,5 l mleka.
Do not use for at least 1 year before the first lambing
Ne uporabite vsaj 1 leto pred prvo jagnjitvijo
Study 1.
1. študija.
As the scope of the current referral was restricted to the evaluation of flukicidal substances, the second active substances in combination products were not assessed.
Ker je bil obseg napotitve omejen samo na vrednotenje snovi proti metljajem, druga zdravilna učinkovina v kombiniranih zdravilih ni bila ovrednotena.
Residue study in milk following oral administration of triclabendazole to cows around the time of calving.
Študija ostankov v mleku po peroralnem dajanju triklabendazola kravam v času telitve.
Based on data from study 1 a ratio of marker to total residues of 0.6 for cattle milk was established at 21 days after oral administration of 14C-triclabendazole.
Na podlagi podatkov iz 1. študije je bilo 21 dni po peroralnem dajanju 14C-triklabendazola ugotovljeno razmerje označevalca proti skupnim ostankom 0,6.
Residues of nitroxinil in milk following subcutaneous administration to sheep and goats
Ostanki nitroksinila v mleku po subkutanem dajanju ovcam in kozam
Where adequate residue data in milk are available these are used to calculate the time required between drug administration and calving or lambing/kidding to ensure that residues in milk do not result in consumer total exposure to residues over the ADI.
Če so na voljo primerni podatki o ostankih v mleku, se lahko uporabijo za izračun časa, ki mora poteči od uporabe zdravila do kotitve, da se zagotovi, da ostanki v mleku ne privedejo do potrošnikove skupne izpostavljenosti ostankom, ki presega vrednost ADI.
Merial B.V.
Nizozemska Merial B.V.
Supaverm Closantel Mebendazole
Supaverm klozantel mebendazol
Plasma and milk levels of clorsulon were recorded.
Zapisovali so ravni klorsulona v plazmi in mleku.
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.
Na voljo ni podatkov o ostankih v mleku, ki bi omogočali izkustveno določanje označevalnega ostanka in razmerja označevalca proti skupnim ostankom v mleku.
Pharmacokinetic study in which 4 male and 4 female cattle were administered a single pouron dose of 20 mg/kg bw closantel.
Farmakokinetična študija na 4 bikih in 4 kravah, ki so prejeli en kožni poliv z odmerkom klozantela 20 mg/kg TM.
Parafend Plus Oral Suspension for Sheep
Parafend Plus Oral Suspension for Sheep klozantel oksfendazol
Amendments in the relevant sections of the package leaflet:
Dopolnila zadevnih poglavij navodila za uporabo:
Triclafas Drench 5% w/v Oral Suspension
Triclafas Drench 5% w/v Oral Suspension triklabendazol
5 g/100 ml intramuscular / subcutaneous /
5 g/100 ml intramuskularna /subkutana/
Do not use for at least 1 year before the first calving
Ne uporabite vsaj 1 leto pred prvo kotitvijo
A single study using a single product was available relating to the use of nitroxinil in milk producing cattle.
V zvezi z uporabo nitroksinila v govedu, namenjenemu pridelavi mleka, je bila na voljo ena študija z enim zdravilom.
The remaining 30% of the ADI corresponds to 27 µg triclabendazole residues.
Preostalih 30 % vrednosti ADI ustreza 27 µg ostankov triklabendazola.
Trodax 34% Nitroxinil
Trodax 34% nitroksinil govedo, ovce
Milk concentrations of triclabendazole and its metabolites were determined over time and the time between treatment and calving was recorded (non GLP study for which limited information on the animal phase of the study is available.
Zapisovali so čas od zdravljenja do telitve (študija brez GLP in z malo podatkov o živalski fazi študije).
08041 Barcelona SPAIN
08041 Barcelona ŠPANIJA
Triclabendazole
triklabendazol
Study 6.
6. študija.
Study 3.
3. študija.
It is concluded that closantel administered orally should not be used during the dry period.
Sledi zaključek, da se klozantel ne sme dajati peroralno med dobo presušitve.
Study 2.
2. študija.
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.
Vendar so vsa v državah članicah (EU/EGP) odobrena zdravila za uporabo v veterinarski medicini, ki vsebujejo klorsulon in se dajejo subkutano, kombinirana zdravila z ivermektinom kot drugo zdravilno učinkovino.
Study 4.
4. študija.
Due to the absence of a MRL in milk these products are not authorised for use in lactating animals.
Teh zdravil zaradi odsotnosti mejne vrednosti ostankov v mleku ni dovoljeno uporabljati pri živalih v obdobju laktacije.
Clorsulon Ivermectin
klorsulon ivermektin
Fascinex 240 Triclabendazole 240 mg/ml
Fascinex 240 triklabendazol
Plasma clorsulon levels were monitored for up to 35 days after administration (GLP compliant).
Do 35 dni po odmerjanju so spremljali plazemske ravni klorsulona (skladno z GLP).
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.
Z metodo časa do varne koncentracije (TTSC) je bila za obe formulaciji s podatki, predstavljenimi v 3. študiji, izračunana časovna točka, ko bi imel 95. percentil zdravljene populacije s 95-odstotnim zaupanjem koncentracijo klozantela v plazmi 2250 µg/l.
Supremadex Solution for Injection
Supremadex Solution for Injection klorsulon ivermektin
Parsifal Bovins Triclabendazole Levamisole
Parsifal Bovins triklabendazol levamizol
Residue depletion study following a single subcutaneous administration of 10 mg/kg bw nitroxinil to 35 pregnant cows.
Študija izločanja ostankov na 35 brejih kravah po enem subkutanem odmerku nitroksinila 10 mg/kg TM.
Virbamec D Solution Injectable
Virbamec D Solution Injectable klorsulon ivermektin
Seponver Plus Closantel Mebendazole
Seponver Plus klozantel mebendazol
Maximec Plus Clorsulon Ivermectin
Maximec Plus klorsulon ivermektin
Romania
ROMUNIJA
4.11 Withdrawal period(s)
= razpolovna doba končnega izločanja (h) in
MRLs established in muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 94.4% of the ADI.
Mejne vrednosti ostankov za mišice, maščobo, jetra in ledvice privedejo do teoretičnega največjega dnevnega vnosa ostankov, ki je enakovreden 94,4 % vrednosti ADI.
It is concluded that closantel administered subcutaneously should not be used during the dry period.
Sledi zaključek, da se klozantela ne sme dajati subkutano med dobo presušitve.
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.
Vendar so vsa v državah članicah (EU/EGP) odobrena zdravila za uporabo v veterinarski medicini, ki vsebujejo klozantel in se dajejo kot kožni poliv, kombinirana zdravila z ivermektinom kot drugo zdravilno učinkovino.
Fasinex 5% Ovino
Fasinex 5% Ovino triklabendazol
Nicosia
NicosiaCIPER
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.
Zaradi odsotnosti teh podatkov je bil izračunan čas, potreben, da je skupno breme ostankov enako varnemu številu molekul v 1,5 l mleka.
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).
Mejne vrednosti ostankov za mišice, maščobo, jetra in ledvice privedejo do teoretičnega največjega dnevnega vnosa ostankov, ki je enakovreden 70 % vrednosti ADI (Zbirno poročilo CVMP, 2001).
Animec Plus Solución inyectable para bovino
Animec Plus Solución inyectable para bovino klorsulon ivermektin
Information not available subcutaneous Information not available
Information not available podatki niso razpoložljivi
08014 Barcelona SPAIN
08014 Barcelona ŠPANIJA
Flukiver Combi Oral Suspension
Flukiver Combi Oral Suspension klozantel mebendazol
Ivomec Super Injection for Cattle
Ivomec Super Injection for Cattle klorsulon ivermektin
Endex 19,5%wässrige Suspension für Rinder
Endex 19,5%wässrige Suspension für Rinder triklabendazol levamizol
Nitroxinil subcutaneous Not possible to determine
Ne uporabite v zadnjem trimesečju brejosti nitroksinil ni mogoče določiti
Amendments in the relevant sections of the summary of product characteristics
Dopolnila zadevnih poglavij povzetka glavnih značilnosti zdravila
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.
Na voljo niso niti primerni podatki o ostankih v mleku ovac, zdravljenih v dobi presušitve niti podatki za določitev razmerja med koncentracijo v mleku in koncentracijo v plazmi pri ovcah.
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.
Sledi zaključek, da se morajo zdravila z nitroksinilom dajati subkutano pred zadnjim trimesečjem brejosti, da koncentracije ostankov v mleku ne privedejo do skupne izpostavljenosti ostankom, ki bi presegla vrednost ADI.
Flukiver combi orale suspensie voor schapen en lammeren
Flukiver combi orale suspensie voor schapen en lammeren klozantel mebendazol ovce, jagnjeta
MRLs established muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 48% of the ADI (CVMP, 2008).
Mejne vrednosti ostankov za mišice, maščobo, jetra in ledvice privedejo do teoretičnega največjega dnevnega vnosa ostankov, ki je enakovreden 48 % vrednosti ADI (CVMP, 2008).
Bimectin Plus 10/100 mg/ml
Bimectin Plus 10/100 mg/ml klorsulon ivermektin
No milk residue data are available following treatment of dairy animals with clorsulon in the dry period.
Podatki o ostankih v mleku po zdravljenju molznic s klorsulonom v dobi presušitve niso na voljo.
Parsifal Ovins Triclabendazole Levamisole
Parsifal Ovins triklabendazol levamizol
Ridafluke 3% Rafoxanide
Ridafluke 3% rafoksanid govedo ovce
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).
Kadar pa metoda TTSC ni primerna, s pristopom varne koncentracije v linearni regresiji (SCLR) (tj. kadar je treba iz razpoložljivih podatkov ekstrapolirati, da se določi časovna točka, pri kateri ostanki padejo pod raven, ki se šteje za varno).
Tribex 10% for cattle
Tribex 10% for cattle triklabendazol
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.
Pri določanju primernega označevalnega ostanka za mleko, ki bi se uporabil kot osnova za razmerje označevalcev glede na skupne ostanke, ni bilo na voljo podatkov o radioaktivnem označevanju.
Milk concentrations of triclabendazole were measured for up to 20 days after calving (GLP compliant)
Do 20 dni po telitvi so spremljali ravni triklabendazola v mleku (skladno z GLP).
08013 Barcelona SPAIN
08013 Barcelona ŠPANIJA
Combifluke Oral Suspension for Sheep
Combifluke Oral Suspension for Sheep klozantel oksfendazol
Tribex 5% orale suspensie voor schapen
Tribex 5% orale suspensie voor schapen triklabendazol
Belgium Novartis Consumer Health B.V. Claudius Prinsenlaan 142
Nizozemska Novartis Consumer Health B.V.
MRLs established in muscle, fat, liver and kidney lead to a theoretical maximum daily intake of residues equivalent to 80% of the ADI.
Mejne vrednosti ostankov za mišice, maščobo, jetra in ledvice privedejo do teoretičnega največjega dnevnega vnosa ostankov, ki je enakovreden 80 % vrednosti ADI.
Tribex 5% Solución Oral Para Ovino
Tribex 5% Solución Oral Para Ovino triklabendazol
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
Ocenjeni dnevni vnos glede na standardno košarico živil za izračun teoretičnega največjega dnevnega vnosa ostankov in izračun mejne vrednosti ostankov Ito, S., Lee, A. (2003) Drug excretion into breast milk- overview.
Tribex 5% for Sheep
Tribex 5% for Sheep triklabendazol
Closamectin FF, solução injectável para bovinos
Closamectin FF, solução injectável para bovinos klozantel ivermektin
Curafluke 10% Rafoxanide Fenbendazole
Curafluke 10% rafoksanid fenbendazol
Norofas Solution for Injection
Norofas Solution for Injection klozantel ivermektin
Bimectin Plus Clorsulon Ivermectin
Bimectin Plus klorsulon ivermektin
Do not use in cattle of any age intended to produce milk for human consumption.
Ne uporabite pri govedu brez omejitve starosti, katerega mleko je namenjeno prehrani ljudi.