natgillin/translations-raw huggingface dataset:
In the CVMP MRL summary report a figure of 0.6 mg selenium/person/day was at the time considered appropriate.
V povzetku poročila MRL odbora CVMP so kot ustrezno vrednost sprejeli 0,6 mg selena/osebo/dan.
There is no ADI set for barium selenate but two different upper tolerable levels for selenium intake for chronic toxicity are available.
Za barijev selenat ni določen noben sprejemljiv dnevni vnos (ADI), vendar obstajata dve različni zgornji meji dopustnega vnosa selena za kronično toksičnost.
In another residue depletion study a product with a colourant specifically aimed at marking the injection site was used.
V drugi študiji izločanja ostankov so uporabili izdelek z barvilom, specifično usmerjenim na označevanje mesta injiciranja.
• the validity of the conclusion, based on the in vitro bioavailability study, that bioavailable residues of barium selenate would make up 5-10% of the total residues (the higher figure for lower concentrations);
• ustreznost zaključka, ki je temeljil na študiji biološke uporabnosti in vitro, da bi biološko uporabni ostanki barijevega selenata predstavljali 5-10 % vseh ostankov (višja številka za nižje koncentracije);
The risk mitigation measures used at present are not suitable to prevent consumer risk for the reasons described above.
Ukrepi za zmanjšanje tveganja, ki se trenutno uporabljajo, iz razlogov, opisanih zgoraj, niso primerni za preprečevanje tveganja za ljudi.
• pharmacovigilance systems would be expected to detect serious adverse events resulting from consumption of meat containing barium selenate residues; the fact that no such events have been detected supports the conclusion that barium selenate injection sites do not pose a threat to consumer safety.
• pričakovati je mogoče, da bodo sistemi farmakovigilance odkrili resne neželene dogodke, ki so posledica uživanja mesa z vsebnostjo ostankov barijevega selenata; dejstvo, da niso zabeležili nobenega tovrstnega dogodka, kaže na pravilnost ugotovitve, da mesta injiciranja barijevega selenata ne predstavljajo nevarnosti za varnost potrošnikov.
Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep.
Barijev selenat se uporablja v zdravilih za injiciranje s počasnim sproščanjem, ki se uporabljajo v veterinarski medicini in so namenjena za terapevtsko in profilaktično uporabo proti pomanjkanju selena pri govedu in ovcah.
The veterinary medicinal products concerned in the referral are given as single subcutaneous injections and contain 177.48 mg barium selenate/ml suspension for injection, equivalent to 50 mg selenium.
Zdravila za uporabo v veterinarski medicini, ki so predmet napotitve, se dajejo z enkratnim injiciranjem pod kožo in vsebujejo 177,48 mg barijevega selenata/ml suspenzije za injiciranje, kar je enakovredno 50 mg selena.
• the CVMP considered that the benefit-risk balance for the long-acting formulations for injection containing barium selenate for all food producing species is negative as the products could pose a significant threat to human health,
• odbor CVMP je menil, da je razmerje med tveganji in koristmi za dolgo delujoče formulacije za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil negativno, ker bi zdravila lahko predstavljala veliko nevarnost za zdravje ljudi,
This implies that the colourant has the same distribution behaviour and residence time as barium selenate.
To pomeni, da se barvilo porazdeli na enak način in je prisotno enak čas kot barijev selenat.
It should be noted that if staining of injection sites via use of a colourant is proposed, suitable data have to be provided confirming that the pigment persists visibly at the injection site for a justified period of time.
Če se predlaga obarvanje mest injiciranja z barvili, je treba upoštevati, da morajo biti predloženi ustrezni podatki, ki potrjujejo, da barvilo ostane vidno na mestu injiciranja primerno dolgo obdobje.
However, the CVMP highlighted that conclusions based on this value should be considered with care as there can be no certainty in relation the accuracy of the derived bioavailability figure for predicting bioavailability in vivo;
Vendar pa je poudaril, da je treba zaključke na podlagi te vrednosti obravnavati previdno, saj ni mogoče z gotovostjo trditi, da je izračunani odstotek biološke uporabnosti za oceno biološke uporabnosti in vivo, pravilen;
• long acting intraruminal devices containing sodium selenate, authorised for cattle only4;
• dolgo delujoče intraruminalne naprave, ki vsebujejo natrijev selenat in so odobrene samo za govedo4;
Scientific conclusions and grounds for refusal of the granting of the marketing authorisation and for suspension of the existing marketing authorisations
Znanstveni zaključki in podlaga za zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom in začasen umik obstoječih dovoljenj
Ireland Tairgi Tread-Lia Baile na Sceilge Teo
Tairgi Tread-Lia Baile na Sceilge Teo Ballinskelligs Killarney Co. Kerry Irska
However, in line with the CVMP guideline on injection site residues (EMEA/CVMP/542/03)5, for substances for which there is no MRL for muscle, the reference value used in the assessment of injection site residues is normally the ADI.
Vendar pa se v skladu s smernicami odbora CVMP o ostankih na mestu injiciranja (EMEA/CVMP/542/03)5 za snovi brez določene MRL za mišice kot referenčna vrednost pri oceni ostankov na mestu injiciranja običajno uporablja sprejemljiv dnevni vnos.
In addition, the data base for the assessment of the oral bioavailability of selenium from barium selenate and its likely uptake and toxicity pathways following oral ingestion has become more complete and additional data on acute selenium toxicity, especially in humans, have become available.
Poleg tega so podatki, ki so osnova za oceno peroralne biološke uporabnosti selena iz barijevega selenata in njegovega verjetnega privzema ter poti absorpcije toksičnih snovi po peroralnem zaužitju, sedaj popolnejši, na voljo pa so postali tudi dodatni podatki o akutni toksičnosti selena, zlasti pri ljudeh.
Cattle are treated at a dose of 1 mg selenium/kg bw, resulting in doses of 2 ml for calves (i.e. 355 mg barium selenate corresponding to 100 mg selenium) and up to 10 ml for adult cattle (i.e. 1,775 mg barium selenate corresponding to 500 mg selenium).
Za zdravljenje goveda se uporablja odmerek 1 mg selena/kg telesne mase, kar pomeni, da je odmerek za teleta 2 ml (tj. 355 mg barijevega selenata, kar je enakovredno 100 mg selena), za odraslo govedo pa do 10 ml (1,775 mg barijevega selenata, kar je enakovredno 500 mg selena).
Due to their formulations, these alternative products for the treatment and prevention of disease relating to selenium deficiency are less convenient for some cases requiring treatment.
Ta alternativna zdravila za zdravljenje in preprečevanje bolezni, povezanih s pomanjkanjem selena, zaradi svojih sestav v nekaterih primerih, ko je potrebno zdravljenje, niso praktična.
Adequate risk mitigation measures to avoid injection site residues entering the food chain are not currently in place.
Trenutno ne obstajajo nobeni ustrezni ukrepi za zmanjšanje tveganja, ki bi pomagali preprečiti vstop ostankov na mestu injiciranja v prehranjevalno verigo.
Using the upper tolerable level established by EFSA of 0.3 mg selenium/person/day it is concluded that the bioavailable fraction of 5% (25 mg) of one injection site would exceed the reference value more than 80 times.
Ob uporabi zgornje meje dopustnega vnosa, ki jo je EFSA določila na 0,3 mg selena/osebo/dan, lahko zaključimo, da bi biološka uporabnost frakcije 5 % (25 mg) enega mesta injiciranja presegla referenčno vrednost za več kot osemdesetkrat.
The EFSA subsequently set a tolerable upper level at 0.3 mg selenium/person/day based on a no observed effect level (NOEL) of 850 µg/day for clinical selenosis in a human study.
Posledično je EFSA določila dopustno zgornjo mejo 0,3 mg selena/osebo/dan na osnovi ravni brez opaznega učinka (NOEL) 850 µg/dan za klinično selenozo v študiji na ljudeh.
The findings of the in vitro study are supported by theoretical considerations based on physicochemical properties of barium selenate, indicating that relevant amounts of selenium could be bioavailable from orally ingested barium selenate i.e. the intake of residues from an injection site would, by simple theoretical estimation based on the solubility product constant, lead to a bioavailable exposure of approximately 15 mg selenium (i.e. 3% of the selenium dose at the injection site) in each litre of water in the intestinal tract.
Ugotovitve študije in vitro potrjujejo teoretične predpostavke na podlagi fizikalno-kemijskih lastnosti barijevega selenata, ki kažejo na biološko uporabnost znatnih količin selena iz peroralno zaužitega barijevega selenata, tj. zaužitje ostankov z mesta injiciranja bi po poenostavljeni teoretični oceni na podlagi konstante topnostnega produkta snovi povzročilo biološko uporabno izpostavljenost približno 15 mg selena (tj. 3 % odmerka selena na mestu injiciranja) v vsakem litru vode v črevesju.
After reviewing all the documentation submitted by the marketing authorisation holders, the CVMP concluded that there were not sufficient scientific grounds to change the overall conclusions of 10 April 2013, which concluded that the benefit-risk balance for the products concerned is negative and that such veterinary medicinal products could pose a significant threat to human health due to persistent selenium residues at the injection site.
Po pregledu celotne dokumentacije, ki sta jo predložila imetnika dovoljenj za promet z zdravili, je odbor CVMP zaključil, da zahteva za spremembo splošnih zaključkov z dne 10. aprila 2013, v katerih je navedeno, da je razmerje med tveganji in koristmi za zadevna zdravila negativno in da bi lahko tovrstna zdravila za uporabo v veterinarski medicini predstavljala veliko nevarnost za zdravje ljudi zaradi obstojnih ostankov selena na mestu injiciranja, ni bila zadovoljivo znanstveno utemeljena.
• the fact that injections are administered subcutaneously limits the risk and furthermore accidental intramuscular injection is very unlikely;
• dejstvo, da se zdravilo injicira pod kožo, zmanjšuje tveganje, zelo malo pa je tudi možnosti za nenamerno intramuskularno injiciranje;
• the CVMP acknowledged that consumption of barium selenate injection sites is likely to be a rare event.
• odbor CVMP se je strinjal, da je zaužitje barijevega selenata z mest injiciranja redek dogodek.
Condition for lifting the suspension of the marketing authorisations
Pogoj za preklic začasnega umika dovoljenj za promet z zdravili
Following injection of barium selenate, residues of selenium in tissues other than the injection site are low, not detectable or at least far below any level of toxicological concern.
Po injiciranju barijevega selenata je ostankov selena v tkivih, ki niso tkiva na mestu injiciranja, malo, jih ni mogoče zaznati ali so daleč pod vsakršno ravnjo toksikoloških zadržkov.
The scientific rational for this withdrawal period is not known as no product specific residue depletion data for the above-mentioned veterinary medicinal were provided in this referral procedure.
Znanstvena utemeljitev za to karenco ni znana, saj v tem napotitvenem postopku za zgoraj omenjena zdravila za uporabo v veterinarski medicini niso bili priloženi nobeni podatki o izločanju ostankov.
This assessment was based on an estimated tolerable upper daily intake in humans corresponding to 0.6 mg selenium/person/day (10 µg/kg bw) and the assumption that oral bioavailability of selenium from barium selenate would be very low (although no quantitative estimate was performed).
Ocena je temeljila na ocenjeni zgornji meji dopustnega dnevnega vnosa pri ljudeh, ki znaša 0,6 mg selena/osebo/dan (10 µg/kg telesne mase), in na predpostavki, da je peroralna biološka uporabnost selena iz barijevega selenata majhna (čeprav kvantitativne ocene niso izvedli).
The upper tolerable level for selenium intake was established in the EU by the Scientific Committee on Food (in 2000) at a lower level of 0.3 mg selenium/person/day (5 µg/kg bw) and was in 2006 confirmed by the Scientific Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority (EFSA).
Znanstveni odbor za prehrano (SCF) je (leta 2000) v EU znižal zgornjo mejo dopustnega vnosa selena na 0,3 mg selena/osebo/dan (5 µg/kg telesne mase), ki jo je leta 2006 odobril Znanstveni svet EFSA za dietetične izdelke, prehrano in alergije (NDA).
This study showed that orally ingested barium selenate (doses of 100 mg or 250 mg per animal similar to those present at injection sites) was absorbed/bioavailable in the gastrointestinal tract.
Študija je pokazala, da se peroralno zaužit barijev selenat (odmerki 100 mg ali 250 mg na žival, ki so podobni količinam na mestih injiciranja) absorbira v črevesju oziroma postane biološko uporaben.
Comparisons of estimated bioavailable doses of selenium following ingestion of an injection site show that the amounts of selenium heavily exceed the toxicological thresholds.
Primerjave ocenjenih biološko uporabnih odmerkov selena po zaužitju mesta injiciranja so pokazale, da so količine selena močno presegle toksikološke mejne vrednosti.
Risk mitigation measures currently in place are not suitable to ensure consumer safety of food derived from animals treated with long acting injectable products containing barium selenate.
Trenutni ukrepi za zmanjšanje tveganja niso primerni za zagotovitev varnosti hrane, ki je bila pridobljena iz živali, zdravljenimi z dolgo delujočimi zdravili za injiciranje, ki vsebujejo barijev selenat, za potrošnika.
However, the available information indicates that the use of veterinary medicinal products containing barium selenate administered subcutaneously pose a significant threat to human health due to persistent selenium residues at the injection site.
Vendar pa razpoložljivi podatki kažejo, da uporaba zdravil za uporabo v veterinarski medicini, ki vsebujejo barijev selenat in se injicirajo pod kožo, predstavlja veliko nevarnost za zdravje ljudi zaradi obstojnih ostankov selena na mestu injiciranja.
Killarney
Karenca
Therefore the CVMP has recommended to suspend the existing marketing authorisations of all longacting injectable veterinary medicinal products containing barium selenate until data ensuring consumer safety following use of the products are provided.
Odbor CVMP je zato priporočil začasno umaknitev obstoječih dovoljenj za promet za vsa dolgo delujoča zdravila za injiciranje, ki vsebujejo barijev selenat in se uporabljajo v veterinarski medicini, dokler ne bodo predloženi podatki, ki bodo zagotovili varnost potrošnikov pri uporabi zdravil.
When weighing the benefit for animal health in prevention and treatment of selenium deficiencies against the risk to public health via residues in food, the benefit-risk balance for long-acting injectable veterinary medicinal products containing barium selenate is considered to be negative.
Če primerjamo koristi za zdravje živali pri preprečevanju in zdravljenju pomanjkanja selena s tveganji za javno zdravje preko ostankov v hrani, je razmerje med tveganji in koristmi za dolgo delujoča zdravila za injiciranje, ki vsebujejo barijev selenat in se uporabljajo v veterinarski medicini, negativno.
Therefore, from an animal husbandry perspective it is therefore unfortunate if the long acting injectables containing barium selenate are not available.
Zato je z vidika živinoreje negativno, če dolgo delujoča zdravila za injiciranje, ki vsebujejo barijev selenat, niso na voljo.
• the CVMP considered that based on the new information from an in vitro study simulating conditions in the human gastrointestinal tract, at least 5% of ingested selenium from barium selenate is bioavailable when present in a normal food matrix;
• odbor CVMP je menil, da je na podlagi novih podatkov iz študije in vitro, v kateri so simulirali pogoje v človeškem črevesju, biološko uporabnih najmanj 5 % zaužitega selena iz barijevega selenata v običajni mešanici hrane;
Germany referred the matter to the CVMP due to serious human health concerns related to exposure to injection site residues from use of long-acting barium selenate containing injectable veterinary medicinal products.
Nemčija je zadevo napotila na odbor CVMP zaradi resnih tveganj za zdravje ljudi, povezanih z izpostavljenostjo ostankom na mestu injiciranja pri uporabi dolgo delujočih zdravil za injiciranje, ki vsebujejo barijev selenat in se uporabljajo v veterinarski medicini.
• the CVMP considered that all residue depletion studies consistently show that, following treatment at recommended doses, barium selenate remains at injection sites for long time periods after treatment and virtually no depletion of residues from the injection site occurs, resulting in high levels of barium selenate at injection site;
• odbor CVMP je menil, da vse študije o izločanju ostankov dosledno kažejo, da po zdravljenju s priporočenimi odmerki barijev selenat ostane na mestih injiciranja še dolgo časa in da se ostanki praktično ne izločajo z mesta injiciranja, kar privede do visokih ravni barijevega selenata na mestu injiciranja;
the CVMP has recommended the refusal of the granting of the marketing authorisation and for suspension of the existing marketing authorisations for long-acting formulations for injection containing barium selenate for all food producing species (see annex I).
je odbor CVMP priporočil zavrnitev vloge za izdajo dovoljenja za promet z zdravilom in začasen umik obstoječih dovoljenj za promet za zdravila z dolgo delujočimi formulacijami za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil (glejte Prilogo I).
Data has been provided to estimate the oral bioavailability of selenium following ingestion of residues of barium selenate.
Predloženi so bili podatki za oceno peroralne biološke uporabnosti selena po zaužitju ostankov barijevega selenata.
Thus, to the CVMP's knowledge, at present there are no authorised long acting injectable products containing barium selenate for use in target species sheep.
Po trenutnem vedenju odbora CVMP ne obstajajo nobena odobrena dolgo delujoča zdravila za injiciranje, ki vsebujejo barijev selenat, za uporabo pri ciljni vrsti ovac.
Oral bioavailability of selenium from barium selenate
Peroralna biološka uporabnost selena iz barijevega selenata
The available residue data indicated that there is practically no depletion of barium selenate from the injection site.
Razpoložljivi podatki o ostankih so pokazali, da se barijev selenat praktično ne izloča z mesta injiciranja.
• in relation to the possibility of dividing the dose into two injections and administering one into each side of the neck, the CVMP considered that the issues related to safe levels of bioavailable selenium residues are not resolved by dividing into two injections.
• v zvezi z možnostjo, da bi odmerek razdelili in ga dali z dvema injekcijama v nasprotna predela vratu, je odbor CVMP menil, da s tem ne bi odpravili tveganj, povezanih z varnimi ravnmi biološko uporabnih ostankov selena.
The withdrawal period of 31 days does not guarantee depletion of residues from the injection site to safe levels as barium selenate residues remain at injection sites for long periods and if ingested, would provide orally bioavailable selenium.
Karenca 31 dni ne zagotavlja zmanjšanja količine ostankov na mestu injiciranja na varno raven, saj ostanki barijevega selenata na mestu injiciranja ostanejo še dolgo časa in bi v primeru zaužitja omogočili peroralno biološko uporabnost selena.
It is administered as a subcutaneous injection at a dose of 1 mg selenium/kg body weight (bw).
Daje se z injiciranjem pod kožo v odmerku 1 mg selena/kg telesne mase.
This study indicates that at least 5% to 10% of ingested selenium from barium selenate is bioavailable when present in a normal food matrix.
Ta študija in vitro je pokazala, da je biološko uporabnih najmanj 5 % do 10 % zaužitega selena iz barijevega selenata v običajni mešanici hrane.
Risk characterisation
Opredelitev tveganja
For the injection site however, all residue depletion studies consistently show that following treatment at recommended doses of barium selenate there is virtually no depletion of residues, which remain at the injection site for a prolonged period of time.
Vendar za mesto injiciranja vse študije o izločanju ostankov dosledno kažejo, da po zdravljenju s priporočenimi odmerki barijev selenat ostane na mestu injiciranja še dolgo časa in da se ostanki praktično ne izločajo z mesta injiciranja.
• injections containing sodium or potassium selenite, authorised for horses, cattle, sheep and pigs;
• zdravila za injiciranje, ki vsebujejo natrijev ali kalijev selenit in so odobrena za uporabo pri konjih,
Grounds for refusal of the granting of the marketing authorisation and for suspension of the existing marketing authorisations
Podlaga za zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom in začasen umik obstoječih dovoljenj
1 mg Se/kg body weight corresponding to the following: Cattle (adult): 6-10 ml
1 mg Se/kg telesne mase, kot sledi: govedo (odraslo govedo):
• the fact that ingestion of barium selenate injection sites will be a rare event and consequently the use of the acceptable daily intake (ADI) as the relevant health based guidance value in the
• dejstvo, da bi bilo zaužitje barijevega selenata z mest injiciranja redek dogodek, kar pomeni, da je uporaba sprejemljivega dnevnega vnosa (ADI) kot orientacijske vrednosti, ob upoštevanju katere naj ne bi bilo tveganja za zdravje, pri oceni tveganj za potrošnike vprašljiva in da bi bilo primerneje uporabiti izračunano vrednost LD50;
5 CVMP guideline on injection site residues (EMEA/CVMP/542/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004429.pdf considered that this would indeed happen in those cases where the injection sites are still detectable, i.e. at early timepoints.
5 Navodila odbora CVMP o ostankih na mestu injiciranja (EMEA/CVMP/542/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004429.pdf presegla ocenjene varne ravni 0,3 mg/osebo/dan, bi moral biti največji sprejemljiv volumen za odraslo govedo 0,12 ml in za celotni odmerek bi morali izvesti več kot 80 injiciranj.
Estonia Cross Vetpharm Group Limited
Estonija Cross Vetpharm Group Limited Broomhill Road Tallaght
In relation to the comments that barium selenate injection sites will be trimmed off and discarded at the slaughter house, the CVMP
V zvezi s trditvijo, da bodo mesta injiciranja barijevega selenata izrezali in odstranili v klavnici, je odbor CVMP menil, da bi se to res zgodilo, a samo v primerih, kjer je mogoče mesta injiciranja še odkriti, tj. v zgodnjih časovnih točkah.
Belgium Cross Vetpharm Group Limited
Belgija Cross Vetpharm Group Limited Broomhill Road Tallaght,
Romania Cross Vetpharm Group Limited
Romunija Cross Vetpharm Group Limited Broomhill Road Tallaght,
France Cross Vetpharm Group Limited
Francija Cross Vetpharm Group Limited Broomhill Road Tallaght,
Sweden Cross Vetpharm Group Limited
Švedska Cross Vetpharm Group Limited Broomhill Road Tallaght,
Latvia Cross Vetpharm Group Limited
Latvija Cross Vetpharm Group Limited Broomhill Road Tallaght,
Slovakia Cross Vetpharm Group Limited
Slovaška Cross Vetpharm Group Limited Broomhill Road Tallaght,
Spain Cross Vetpharm Group Limited
Španija Cross Vetpharm Group Limited Broomhill Road Tallaght,
Poland Cross Vetpharm Group Limited
Poljska Cross Vetpharm Group Limited Broomhill Road Tallaght,
Denmark Cross Vetpharm Group Limited
Danska Cross Vetpharm Group Limited Broomhill Road Tallaght,
Minor formatting changes were also introduced.
Uvedene so bile tudi manjše spremembe v oblikovanju.
Overall summary of the scientific evaluation of Quixil
Splošni povzetek znanstvenega vrednotenja zdravila Quixil
As a result, gas embolism may occur even with a reduced pressure.
Posledično lahko pride do plinske embolije tudi ob znižanem tlaku.