natgillin/translations-raw huggingface dataset:
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.
Za izračun skupnega števila vnesenih molekul so potrebni naslednji podatki: celotni terapevtski odmerek, ki ga prejme žival; telesna masa živali; molska masa zdravilne učinkovine in Avogadrovo število.
If no such data are available, the milk to plasma ratio could, in principle, be calculated on the basis of the pKa, degree of lipid solubility (ie the relative concentrations of ionised and unionised free drug), the degree of protein binding in plasma and milk, and assuming standard pH values for plasma and milk (Rasmussen, 1966).
Če taki podatki niso na voljo, je razmerje med mlekom in plazmo načeloma mogoče izračunati na podlagi vrednosti pKa, stopnje topnosti v maščobah (tj. relativnih koncentracij ioniziranega in neioniziranega prostega zdravila), stopnje vezave na beljakovine v plazmi in mleku ter predpostavke standardnih vrednosti pH v plazmi in mleku (Rasmussen, 1966).
78 days
78 dni
The conclusions of this referral will remain appropriate even if the recommended milk MRLs are established for the above substances, unless product specific data are submitted to the national competent authorities for the establishment of milk withdrawal periods.
Zaključki te napotitve ostajajo ustrezni tudi, če se potrdijo priporočene mejne vrednosti ostankov za navedene snovi, razen če se nacionalnim pristojnim organom predložijo specifični podatki za določitev karence za mleko.
300 mg/tab Tablets oral
300 mg/tab tablete
The ‘SCLR' (Safe concentrations based on linear regression)4 method was used to extrapolate from the combined plasma depletion data available for the two formulations used in study 2.
Z metodo „SCLR“ (varne koncentracije na podlagi linearne regresije)4 je izvedena ekstrapolacija kombiniranih podatkov izločanja iz plazme za obe formulaciji iz 2. študije.
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.
Količina in kakovost razpoložljivih podatkov nista primerljivi s količino in kakovostjo podatkov, ki se navadno zberejo kot osnova za določanje mejne vrednosti ostankov ali karenc, zato so priporočila splošna in konservativna ter niso specifična za zdravilo - brez upoštevanja razlik v formulaciji, jakosti in odmerjanju.
Helmizol Plus Clorsulon mg/bolus
Helmizol Plus klorsulon mg/bolus bolus
Romavermectina B1 1% Plus
Romavermectina B1 1% Plus klorsulon ivermektin
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.
Na podlagi podatkov 1. študije je razmerje rafoksanida proti skupnim ostankom v mleku govedi približno od 0,25 do 0,35.
The data from this residue study in milk were not suitable for determination of a safe pre-calving interval.
Podatki iz te študije ostankov v mleku niso primerni za določanje varnega presledka pred telitvijo.
However, based on the results of study 1 the milk/serum concentration ratio of rafoxanide (measured as radiolabelled Iodine in chloroform extract) was approximately 1/30.
Vendar rezultati 1. študije kažejo, da je razmerje koncentracije rafoksanida v mleku in koncentracije v serumu (izmerjeno z radioaktivnim jodom v ekstraktu s kloroformom) približno 1/30.
It is acknowledged that the guidance relates to methods for establishing withdrawal periods for milk, however, because the type of data to be evaluated in this referral is similar to that typically evaluated for the establishment of withdrawal periods, the use of these approaches is considered appropriate here.
Priznava se, da se navodilo nanaša na metode za določanje karenc za mleko, vendar je vrsta podatkov, vrednotenih v tej napotitvi, podobna tistim, ki se navadno vrednotijo pri določanju karenc, zato se uporaba teh pristopov šteje za primerno.
el equation 1
el enačba 1,
Quinn's Chemist Bridge Street Crossmolina Co. Mayo IRELAND
Quinn's Chemist Bridge Street Crossmolina Co. MayoIRSKA
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.
Čeprav se priznava, da je ta pristop konservativen, v odsotnosti drugih pomembnih podatkov zagotavlja oceno časovne točke, ko se ostanki v mleku lahko štejejo za varne.
The results showed that the marker residue in milk at the first milking is below the safe concentration when a pre-calving period of 2 months is respected.
Rezultati so pokazali, da je raven označevalnega ostanka v mleku prve molže pod varno koncentracijo, če se uporabi 2-mesečni presledek pred telitvijo.
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.
Kot zadnje, test za ostanke nitroksinila v mleku, ki ga je imetnik dovoljenja za promet predlagal za zagotovitev ohranjanja ravni ostankov pod ravnijo varnosti tudi v primeru prezgodnjih telitev, v tej napotitvi ni bil upoštevan zaradi pomanjkanja podrobnih podatkov o testu samem.
Plasma levels of rafoxanide were measured for up to 672 hours post treatment (GCP for animal phase and GLP for analytical phase)Bloomfield, 1991
Merili so ravni rafoksanida v plazmi do 672 ur po zdravljenju (GCP za fazo na živalih in GLP za analitično fazo) - Bloomfield, 1991
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.
Ker je hitrost izločanja med končno fazo izločanja za vse telesne kompartmente enaka, lahko čas, potreben za izločitev zdravila iz telesa, ocenimo z uporabo končne razpolovne dobe snovi na številu vnesenih molekul.
The data did not show a clear relationship between the length of the dry period and closantel levels in milk from the first milking, and consequently could not be used to determine a time point at which administration could be considered safe for the consumer.
Podatki ne kažejo jasne odvisnosti med dolžino dobe presušitve in ravnmi klozantela v mleku prve molže, zato jih ne moremo uporabiti za določevanje časovne točke po odmerjanju, ki se šteje varno za potrošnika.
It is a recommendation relating to an approximate, and necessarily conservative, time period that should be allowed to elapse between product administration and calving in order to ensure that nitroxinil residues in milk deplete to safe levels.
Gre za priporočilo glede približnega in neizogibno konservativnega časovnega presledka med uporabo zdravila in telitvijo, da se zagotovi upad ravni ostankov nitroksinila v mleku na varne ravni.
Both the immature and mature flukes are harmful to the target species, and each flukicide has varying efficacy against different ages of fluke.
Za ciljne vrste so nevarne nezrele in zrele oblike metljaja, sredstva proti metljajem pa imajo različno učinkovitost proti različno starim metljajem.
Although data were not available that would allow empirical derivation of a marker to total residues ratio in sheep milk, the ratio of 0.3 was considered to be sufficiently conservative to apply ovine milk as well as to bovine milk.
Čeprav niso bili razpoložljivi podatki, ki bi omogočili izkustveno izpeljavo razmerja označevalca proti skupnim ostankom v ovčjem mleku, se razmerje 0,3 šteje za dovolj konservativnega, da velja za ovčje in kravje mleko.
In making recommendations for safe time spans to be applied between administration of a product and collection of milk for human consumption, consideration will also be given to ensuring compatibility with normal animal husbandry practices.
Upoštevanje realističnih varnih časovnih presledkov Pri priporočilih za varne časovne presledke med uporabo zdravila in zbiranjem mleka za prehrano ljudi se bo upoštevala tudi združljivost z običajnimi živinorejskimi praksami.
Use of the same marker residue was considered appropriate for milk.
Za mleko se je kot primeren upošteval isti označevalni ostanek.
This implies that in general, the ratio between the concentration of a drug in plasma and the concentration in milk will remain constant over time.
To pomeni, da splošno gledano razmerje med koncentracijo zdravila v plazmi in koncentracijo zdravila v
Univet Limited Tullyvin Cootehill Co. Cavan IRELAND
Univet Limited Tullyvin Cootehill Co. Cavan IRSKA
Table - Safe time spans between treatment and calving or lambing/kidding for five flukicidal substances
Preglednica - Varni časovni presledki med zdravljenjem in kotitvijo za pet snovi proti metljajem
The Committee emphasised that while such an approach may provide a useful tool for estimating residue levels in milk in the absence of milk data, the approach would not be acceptable for the establishment of MRL values.
Odbor je poudaril, da je lahko tak pristop uporabno orodje za oceno ravni ostankov v mleku, če podatkov za mleko ni, a ni sprejemljiv za določanje mejnih vrednosti ostankov.
It should be noted that many (155) of the clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole containing products are combination products containing other active substances.
Treba je izpostaviti, da je veliko zdravil (155), ki vsebujejo klorsulon, klozantel, nitroksinil, rafoksanid ali triklabendazol, kombiniranih z drugimi zdravilnimi učinkovinami.
Minimum safe time span
Pot uporabe Najkrajši varni časovni presledek
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):
Enačbo lahko preoblikujemo tako, da dobimo čas, potreben, da je skupno breme ostankov v telesu enako razpoložljivemu deležu vrednosti ADI, ki predstavlja ostanke v 1,5 l mleka (ob upoštevanju največje teoretične izpostavljenosti ostankom, izračunane iz obstoječih mejnih vrednosti ostankov za tkiva):
Wirtz Farma B.V.
Nizozemska Wirtz Farma B.V.
Loughrea, Co. Galway IRELAND
Loughrea, Co. Galway IRSKA
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer THE NETHERLANDS
Wim de Körverstraat 35 5831 AN Boxmeer NIZOZEMSKA
Belgium Norbrook Laboratories Ltd Station Works
Portugalska Norbrook Laboratories Ltd Station Works
Laboratorios Cenavisa, s.a. Cami Pedro Estela, S/N 43205 Reus (Tarragona) SPAIN
Laboratorios Cenavisa, s.a. Cami Pedro Estela, S/N 43205 Reus (Tarragona) ŠPANIJA
After reviewing the documentation submitted by the marketing authorisation holder and after considering the information provided during the oral explanation, the CVMP concluded that there were not sufficient scientific grounds to revise its conclusions of 8 March 2012 on the restrictions that should be applied to the use of nitroxinil in dairy cattle in order to avoid residues in milk occurring at levels that could compromise consumer safety.
Odbor je po pregledu dokumentacije, ki jo je predložil imetnik dovoljenja za promet z zdravilom, in po obravnavi podatkov, ki so bili predloženi med ustno razlago, zaključil, da ni dovolj znanstvenih podlag za spremembo zaključka Odbora z dne 8. marca 2012 glede omejitev pri uporabi nitroksinila pri kravah molznicah, da se preprečijo ravni ostankov v mleku, ki bi ogrozile varnost potrošnikov.
With regard to veterinary medicinal products containing triclabendazole and moxidectin and administered as pour-on to cattle (see Annex I), the Committee concluded that any use in dairy animals might result in unacceptable residue levels in milk.
Za zdravila za uporabo v veterinarski medicini, ki vsebujejo triklabendazol in moksidentin ter se dajejo govedu kot kožni poliv (glejte Prilogo I), Odbor meni, da vsaka uporaba pri molznicah lahko privede do nesprejemljivih ravni ostankov v mleku.
The only available residue study (study 1) demonstrates that milk from animals whose dry period lasted at least 71 days did not contain nitroxinil at levels above 20 μg/l.
V edini razpoložljivi študiji ostankov (1. študiji) so dokazali, da mleko živali, katerih doba presušitve traja vsaj 71 dni, ne vsebuje nitroksinila nad 20 μg/l.
The control of liver fluke is achieved primarily by treatment with veterinary medicinal products containing flukicidal substances and is also assisted by appropriate husbandry measures (e.g. not grazing low-lying pastures or wet pastures near ponds and streams).
Obvladovanje velikega metljaja dosežemo predvsem z zdravljenjem z zdravili za uporabo v veterinarski medicini, ki vsebujejo snovi proti metljajem, skupaj z ustreznimi živinorejskimi ukrepi (npr. preprečevanje paše na nizkoležečih pašnikih ali mokrih pašnikih blizu jezer in potokov).
136 days
136 dni
However, it is noteworthy that for all substances and routes for which data were made available for this referral, residue levels in milk are always considered to have deplete to a safe level by one year after administration of the substance.
Kljub temu je treba izpostaviti, da se za vse snovi in poti uporabe, za katere so bili predloženi podatki v tej napotitvi, šteje, da se ravni ostankov v mleku vedno izločijo na varno raven po enem letu po uporabi snovi.
As the scope of the current referral concerns flukicidal substances for which MRLs have not been established in milk, formal withdrawal periods could be not recommended as part of this evaluation.
Ker obseg te napotitve zadeva snovi proti metljajem, za katere mejne vrednosti ostankov v mleku niso določene, uradne karence ni mogoče priporočiti kot del tega vrednotenja.
In addition, as depletion of nitroxinil residues in milk will be affected by the time between treatment and calving and as, in practice, the calving date is difficult to predict, it is not considered appropriate to express the time period that needs to elapse following product administration in terms of a precise number of days to calving.
Poleg tega na izločanje ostankov nitroksinila v mleku vpliva časovni presledek med zdravljenjem in telitvijo ter ker je v praksi datum telitve težko napovedati, ni primerno izražati časovnega presledka po uporabi zdravila v točnem številu dni do telitve.
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.
Snovi proti metljajem, za katere ni bila določena mejna vrednost ostankov v mleku in ki so vključene kot zdravilne učinkovine v zdravila za uporabo v veterinarski medicini, odobrena v državah članicah (EU/EGP), so klorsulon, klozantel, nitroksinil, rafoksanid in triklabendazol.
Rafoxanide/Prov et
Rafoxanide/Prov et rafoksanid
However, closantel depletion profiles have been shown to be similar in milk and plasma, with a milk to plasma ratio of 0.02 (study 5 above).
Vendar je dokazano, da so profili izločanja klozantela podobni v mleku in plazmi, pri čemer razmerje med mlekom in plazmo znaša 0,02 (zgoraj omenjena 5. študija).
272 days
272 dni
However, the treatment of heifers with closantel administered orally can be regarded as safe as long as it occurs within the first half of the gestation period.
Zdravljenje telic s peroralnim dajanjem klozantela se lahko šteje za varno, če se opravi v prvi polovici brejosti.
359 days
359 dni
Flukex 9% Rafoxanide
Flukex 9% rafoksanid
5531 AH Bladel THE NETHERLANDS
5531 AH BladelNIZOZEMSKA
Based on this, the marketing authorisation holder considered that the CVMP recommendation that nitroxinil containing products should not be used during the last trimester of gestation was unnecessarily conservative for the product in question.
Imetnik dovoljenja za promet na podlagi tega meni, da je priporočilo Odbora, da se zdravila, ki vsebujejo nitroksinil, ne smejo uporabljati v zadnjem trimesečju brejosti, nepotrebno konservativno za zadevno zdravilo.
However, these substances are administered during the dry period for the prevention and treatment of trematode infections in dairy animals.
Vendar se te snovi dajejo med dobo presušitve za preprečevanje in zdravljenje okužb z metljaji pri molznicah.
in which T = time (days), dose = total dose (g/kg bw/day), duration = treatment duration (days), bw = bodyweight (kg), A = Avogadro's number = 6.0 * 1023, M = Molar mass (g/mol), t1/2 = terminal elimination half-life (h), and in which
bw duration enačba 2, v kateri je T = čas (dnevi), dose = celotni odmerek (g/kg TM/dan), duration = trajanje zdravljenja (dnevi), bw = telesna masa (kg), A = Avogadrovo število = 6,0 * 1023, M = molska masa (g/mol), t1/2
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.
Vendar je bil nitroksinil določen kot označevalni ostanek v tkivih goveda (Zbirno poročilo CVMP, 1998), za spojino pa je znano, da je poglavitni ostanek v maščobi, mišicah, ledvicah in plazmi.
However, it was noted that, in many cases, adequate residue depletion data in milk from dairy animals treated during the non-lactating period is not available.
Vendar je bilo ugotovljeno, da v veliko primerih primerni podatki o izločanju ostankov v mleku, pridobljenih pri molznicah, zdravljenih zunaj obdobja laktacije, niso na voljo.
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.
V primerih, ko ustrezni podatki o ravneh ostankov v mleku ali plazmi niso razpoložljivi, se lahko uporabi strožji farmakokinetični pristop za izračun časa, potrebnega za izločitev zadostne količine ostankov, tako da je količina preostanka ostankov v telesu živali tolikšna, da ob prisotnosti celotnega preostanka ostankov v 1,5 l mleka2 potrošnikova skupna izpostavljenost ostankom (vključno z ostanki v drugih živilih) ne preseže vrednosti ADI.
Flukicidal substances are anthelmintics which are active against parasites belonging to the class of trematodes.
Zdravila proti metljajem so antihelmintiki, ki so učinkoviti proti parazitom iz skupine metljajev.
Not relevant as used in combination products only
Ni relevantno, ker se uporablja samo v kombiniranih zdravilih klozantel
Therefore, the Committee recommended the amendment of section 4.11 Withdrawal period(s) of the SPC of the relevant products to indicate that the products should not be used in dairy animals of any age.
Zato je Odbor priporočil spremembo poglavja 4.11 Karenca v povzetku glavnih značilnosti zadevnih zdravil, ki bo odražala, da se zdravila ne smejo uporabljati pri molznicah vseh starosti.
The residue depletion study following pour-on administration (study 2) showed that residues were detectable in a small number of animals, sometimes in excess of 10 µg/l.
Študija izločanja ostankov po dajanju kožnega poliva (2. študija) je pokazala, da so ostanki še vedno zaznavni pri majhnem številu živali in so v določenih primerih presegali 10 µg/l.
Flukicides play a critical role in the prevention and control of trematode infections.
Snovi proti metljajem imajo odločilno vlogo pri preprečevanju in obvladovanju okužb z metljaji.
Consequently, a safe time span for the pour-on use of triclabendazole before calving cannot be established.
Zato varnega časovnega obdobja za uporabo triklabendazola v obliki kožnega poliva pred telitvijo ni mogoče določiti.
Based on this study, the parent compound, rafoxanide, was concluded to be the appropriate marker residue in milk, and a ratio of marker to total residues of 0.3 was established.
Na podlagi te študije se je izvorna spojina, rafoksanid, štela za primeren označevalni ostanek za mleko in določilo se je razmerje med označevalcem in skupnimi ostanki, ki znaša 0,3.
However, the treatment of heifers with closantel administered subcutaneously can be regarded as safe as long as it occurs only during the first or second trimesters (and not during the third trimester) of the gestation period.
Zdravljenje telic s subkutanim dajanjem klozantela se lahko šteje za varno le, če se opravi v prvem ali drugem trimesečju (ne pa v tretjem trimesečju) brejosti.
For all combination products other than those that cannot be used in dairy animals at any time, the national competent authorities will need to determine whether the recommendations concerning the substances evaluated in this referral are sufficient to ensure that residues in milk of the non-flukicidal active substance will not occur at unsafe levels.
Za vsa kombinirana zdravila, razen tistih, ki se ne smejo nikoli uporabiti pri molznicah, bodo morali nacionalni pristojni organi odločiti, ali so priporočila v zvezi s snovmi, obravnavanimi v tej napotitvi, zadostna, da se zagotovi, da so ostanki zdravilne učinkovine, ki ne deluje proti metljajem, v mleku prisotni v še varnih koncentracijah.
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).
Za kombinirana zdravila, ki se dajejo kot kožni poliv, velja zaključek za snov proti metljajem triklabendazol, da se ne smejo uporabljati pri molznicah vseh starosti, kar je scenarij najslabšega primera in velja za vse kombinirane kožne polive s triklabendazolom (tj. triklabendazolom in moksidektinom).
Plasma and milk concentrations of closantel in cattle were reported following a single intramuscular dose.
Koncentracije klozantela v plazmi in mleku so ugotavljali po enem intramuskularnem odmerku.
C & H Generics Ltd c/o Michael McEvoy Seville House New Dock Street Galway
C & H Generics Ltd c/o Michael McEvoy Seville House New Dock Street GalwayIRSKA
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.
Ponovni pregled se je nanašal na priporočene spremembe poglavja 4.11 Karenca v povzetku glavnih značilnosti zdravil za uporabo v veterinarski medicini, ki vsebujejo nitroksinil in se dajejo govedu.
Therefore no conclusion could be drawn on the instructions to be included in the product information of combination products, with the exception of veterinary medicinal products in Annex I containing triclabendazole and moxidectin and administered as pour-on, for which the conclusion on the flukicidal substance is that it cannot be used in dairy animals at any time.
Zato niso mogoči zaključki o navodilih, ki bi se vključila v informacije o zdravilih za kombinirana zdravila, razen za zdravila za uporabo v veterinarski medicini iz Priloge I, ki vsebujejo triklabendazol in moksidektin ter se dajejo kot kožni poliv, saj zanje velja zaključek glede snovi proti metljajem, da se ne smejo nikoli uporabiti pri molznicah.
It should also be noted that since the commencement of this referral, MRLs have been recomended for clorsulon in bovine milk, for closantel and nitroxinil in bovine and ovine milk, and for triclabendazole in milk of all ruminants.
Poleg tega so bila po začetku te napotitve izdana priporočila mejnih vrednosti ostankov za klorsulon v kravjem mleku, klozantel in nitroksinil v kravjem in ovčjem mleku ter za triklabendazol v mleku vseh prežvekovalcev.