FrancophonIA/ELRC3.0 huggingface dataset:
English: Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep.
Estonian: Baariumselenaati on aeglaselt vabaneva süstitava veterinaarravimina kasutatud seleenivaeguse ennetamiseks ja raviks veistel ning lammastel.
English: It is administered as a subcutaneous injection at a dose of 1 mg selenium/kg body weight (bw).
Estonian: Veterinaarravimit manustatakse subkutaanse süstena annuses 1 mg seleeni kehamassi kg kohta (mg/kg).
English: • conclusions on bioavailability in sheep drawn from the Archer and Judson (1994)3 study cannot be readily extrapolated to humans;
Estonian: • Publikatsiooni Archer ja Judson (1994)3 uuringu järeldusi biosaadavuse kohta lammastel ei saa otseselt üle kanda inimestele.
English: 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.
Estonian: Uuringus leiti, et suukaudne baariumselenaat (annuses 100 mg või 250 mg looma kohta ehk süstekohas sisalduvaga sarnane kogus) imendus seedetraktist ja oli biosaadav.
English: The available residue data indicated that there is practically no depletion of barium selenate from the injection site.
Estonian: Olemasolevad jääkide andmed näitasid, et baariumselenaadi kogus süstekohas praktiliselt ei vähenenud.
English: Any health based reference value must be capable of reflecting non-serious adverse effects;
Estonian: Mis tahes tervisepõhine suunisväärtus peab arvestama ka mitteraskeid kõrvaltoimeid.
English: 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.
Estonian: Samas näitavad kõik süstekoha jääkide vähenemise uuringud ühtmoodi, et baariumselenaadi soovitatavate annustega toimuva ravi järel jäägid praktiliselt ei vähene, vaid püsivad süstekohas pikka aega.
English: • 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.
Estonian: • Annuse kaheks teine teisele poole kaela manustatavaks süsteks jagamise võimaluse suhtes järeldas komitee, et see ei lahenda biosaadavate seleenijääkide ohutu koguse küsimust.
English: Grounds for refusal of the granting of the marketing authorisation and for suspension of the existing marketing authorisations
Estonian: Müügiloa andmisest keeldumise ja kehtivate müügilubade peatamise alused
English: In the CVMP MRL summary report a figure of 0.6 mg selenium/person/day was at the time considered appropriate.
Estonian: Veterinaarravimite komitee pidas jääkide piirnormide kokkuvõttearuandes sobivaks väärtuseks 0,6 mg seleeni inimese kohta ööpäevas.
English: • the CVMP acknowledged that consumption of barium selenate injection sites is likely to be a rare event.
Estonian: • Komitee nõustus, et baariumselenaadi süstekohtade tarbimist toiduna esineb tõenäoliselt harva.
English: Data has been provided to estimate the oral bioavailability of selenium following ingestion of residues of barium selenate.
Estonian: On esitatud andmed, et hinnata seleeni suukaudset biosaadavust pärast baariumselenaadi jääke sisaldava toidu manustamist.
English: • long acting intraruminal devices containing sodium selenate, authorised for cattle only4;
Estonian: • naatriumselenaati sisaldavad pikatoimelised intraruminaalsed ravivahendid, mis on heaks kiidetud kasutamiseks üksnes veistel4;
English: 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.
Estonian: Seega ei ole veterinaarravimite komitee teada praegu müügiluba mitte ühelgi pikatoimelisel baariumselenaati sisaldaval veterinaarravimil, mis on ette nähtud kasutamiseks lammastel.
English: Proc. Aust.
Estonian: Aust.
English: 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).
Estonian: soovitab veterinaarravimite komitee keelduda kõigil toiduloomadel kasutatavate pikatoimeliste baariumselenaati sisaldavate süstitavate ravimvormide (vt I lisa) müügiloa andmisest ja peatada nende kehtivad müügiload.
English: As previous studies indicated, barium selenate remains at the injection site for a long time.
Estonian: Varasemate uuringute andmetel püsib baariumselenaat süstekohas kaua.
English: 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.
Estonian: Koostise tõttu on nende alternatiivsete seleenivaegusest tingitud haiguste ravi ja ennetamise toodete kasutamine mõningatel ravi vajavatel juhtudel ebamugavam, mille tõttu tekitaks baariumselenaadi pikatoimeliste süstitavate ravimvormide kadumine turult loomakasvatajatele probleeme.
English: Lithuania
Estonian: Läti
English: In addition residue depletion data generated with a product containing a colourant specifically aimed at marking the injection site (ferric oxide), injection sites were not clearly identifiable in all animals and could not be completely removed.
Estonian: Samuti ei olnud süstekohad kõigil loomadel selgelt näha ja neid ei saanud täielikult eemaldada ka uuringus, kus kasutati veterinaarravimit, millele süstekoha märkimiseks oli lisatud spetsiaalset värvainet (raud(III)oksiidi).
English: Germany
Estonian: Belgia
English: Co. Kerry
Estonian: I lisa
English: Killarney
Estonian: Tallaght,
English: 4 Products also contain cobalt and copper evaluation of consumer safety concerns is questionable and that a more appropriate value would be the calculated LD50;
Estonian: • Asjaolu, et baariumselenaadi süstekohtade tarbimist toiduna toimub harva, mistõttu lubatava ööpäevase tarbimise koguse (ADI) kasutamine asjakohase tervisepõhise suunisväärtusena tarbijate ohutuse hindamisel on küsitav, ja et kohasem näitaja oleks arvutuslik LD50.
English: The CVMP assessed the detailed grounds for the re-examination and the CVMP's conclusions in relation to each of the bullets above are summarised below:
Estonian: Komitee järeldused iga argumendi kohta on kokkuvõttes järgmised:
English: • risks could be further mitigated by dividing the dose into two injections given into opposite sides of the neck; in practice risks will also be mitigated as Official Veterinarians working at slaughterhouse will see blemishes resulting from barium selenate injections and ensure that the relevant areas of tissue are discarded;
Estonian: • Riske saab veelgi vähendada, kui jagada annus kaheks süsteks, mis manustatakse teine teisele poole kaela.
English: Romania Cross Vetpharm Group Limited
Estonian: Rumeenia Cross Vetpharm Group Limited
English: Slovakia Cross Vetpharm Group Limited
Estonian: Slovakkia Cross Vetpharm Group Limited
English: This study indicates that at least 5% to 10% of ingested selenium from barium selenate is bioavailable when present in a normal food matrix.
Estonian: baariumselenaadina manustatud seleenist on biosaadav, kui see sisaldub tavapärases toidus.
English: Dalmasel L.A. 50 mg/ml, suspensión inyectable para bovino
Estonian: 50 mg/ml, suspensión inyectable para bovino
English: France Cross Vetpharm Group Limited
Estonian: Prantsusmaa Cross Vetpharm Group Limited
English: • 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.
Estonian: Selliste juhtumite puudumine kinnitab järeldust, et baariumselenaadi süstekohad ei ohusta tarbijaohutust.
English: Spain Cross Vetpharm Group Limited
Estonian: Hispaania Cross Vetpharm Group Limited
English: INN Pharmaceutical form
Estonian: Manustamisviis Soovituslik annus
English: Oral bioavailability of selenium from barium selenate
Estonian: Seleeni suukaudne biosaadavus manustamisel baariumselenaadina
English: Inappropriate distance from the tissue surface
Estonian: Ebaõige kaugus koe pinnast
English: Benefit Risk balance
Estonian: Kasulikkuse ja riski suhe
English: Overall summary of the scientific evaluation of Quixil
Estonian: Quixili teadusliku hindamise üldkokkuvõte
English: The pressure range for Quixil is therefore higher (2.0-2.5 bar) compared with that of Evicel (1.0-1.7 bar).
Estonian: Nii on Quixili rõhuvahemik (2,0-2,5 bar) suurem kui Eviceli oma (1,0-1,7 bar).
English: Scientific Discussion
Estonian: Teaduslik arutelu
English: Annex II Scientific conclusions and grounds for variation to the terms of the Marketing Authorisations
Estonian: II lisa Teaduslikud järeldused ja müügiloa tingimuste muutmise alused
English: Based on the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 21 May 2012, requesting the CHMP to assess the above concerns and their impact on the benefit-risk for Evicel, to give its opinion on measures necessary to ensure the safe and effective use of Evicel and on whether the marketing authorisation for this product should be maintained, varied, suspended or withdrawn.
Estonian: Nendel põhjustel algatas Euroopa Komisjon 21. mail 2012 määruse (EÜ) nr 726/2004 artikli 20 kohase menetluse, küsides inimravimite komitee hinnangut ülalnimetatud probleemi ning selle mõju kohta Eviceli kasulikkuse ja riski suhtele ning arvamust Eviceli ohutu ja efektiivse kasutamise tagamiseks vajalike meetmete kohta ning kas ravimi müügiluba tuleb säilitada, muuta, peatada või tühistada.
English: Evicel was sprayed antero-laterally via pressure regulator with N2 (nitrogen) for a single two-second burst at approximately 2½ to 3 centimetres with reduced pressure of 8 (eight) PSI.
Estonian: Eviceli pihustati anterolateraalselt rõhuregulaatori kaudu N2-ga (lämmastik) ühe 2 s impulsina u 2,5-3 cm kauguselt väikesel rõhul 8 (kaheksa) psi.
English: The expert unanimously agreed that the risk of air embolism is not related to the medicinal product itself but to the device design and its misuse in practice.
Estonian: Eksperdid olid üksmeelsel arvamusel, et õhkemboolia risk ei ole seotud mitte ravimi enda, vaid pihusti ja selle ebaõige kasutamisega.
English: Spraying Quixil in endoscopic procedures should therefore be contra-indicated.
Estonian: Quixili pihustamine endoskoopiaprotseduuridel peab seetõttu olema vastunäidustatud.
English: The MAH confirmed that the shipment of Quixil in Europe had ceased in May 2012 and that only very few units of Quixil were available in France and Italy.
Estonian: Müügiloa hoidja kinnitas, et Quixili tarnimine Euroopas lõppes mais 2012 ning ainult väikesi Quixili koguseid turustati Prantsusmaal ja Itaalias.
English: The CHMP agreed that the DHPC should be circulated to all Quixil users in France and Italy, no later than 30 November 2012.
Estonian: Komitee leppis kokku, et tervishoiutöötajate teatis tuleb edastada kõigile Quixili kasutajatele Prantsusmaal ja Itaalias 30. novembriks 2012.
English: The CHMP revised the Quixil PI accordingly, to ensure the safe and effective use of Quixil (see Annex III).
Estonian: Inimravimite komitee muutis vastavalt Quixili ravimiteavet, et tagada Quixili ohutu ja efektiivne kasutamine (vt III lisa).
English: As a result, gas embolism may occur even with a reduced pressure.
Estonian: Nii võib gaasemboolia tekkida ka väikese rõhu kasutamisel.
English: Despite risk mitigation activities put in place between August 2010 and early 2011 for Quixil and Evicel, including: 1) a direct healthcare professional communication regarding a change in product labelling, 2) field safety notification for the pressure regulator including change in the instructions for use, and 3) updated customer training programs, two new cases of air embolism (and a third one during the referral procedure) have been reported following use of the spray application of Evicel (one non-fatal case in August 2011 and a fatal case in January 2012).
Estonian: Kuigi Quixili ja Eviceli korral võeti augustist 2010 kuni 2011. aasta alguseni riskivähendusmeetmed, sealhulgas 1) tervishoiutöötajate teatis ravimiteabe muudatuste kohta, 2) ohuteade rõhuregulaatori kohta koos kasutusjuhendi muudatustega ja 3) ajakohastatud koolitusprogramm toodete kasutajatele, teatati 2 uuest õhkemboolia juhust (kolmandast teatati esildismenetluse ajal) pärast Eviceli pihustamist (1 mittefataalne juht augustis 2011 ja 1 fataalne juht jaanuaris 2012).
English: Following this, the UK's Medicines and Healthcare products Regulatory Agency triggered a procedure under Article 31 on 24 May 2012, requesting the CHMP to carry out the same assessment for the other fibrin sealants available in the EU, including Quixil.
Estonian: Selle järel algatas Ühendkuningriigi ravimiamet 24. mail 2012 artikli 31 kohase menetluse, küsides inimravimite komiteelt samasugune hinnangut ka teiste Euroopa Liidus turustatavate fibriinliimide, sealhulgas Quixili kohta.
English: The fibrinogen component of Quixil also contains tranexamic acid.
Estonian: Quixili fibrinogeenkomponent sisaldab ka traneksaamhapet.
English: Minor formatting changes were also introduced.
Estonian: Samuti muudeti veidi ravimiteabe vormingut.
English: With regard to safety, the CHMP noted that the main risk with sprayable fibrin sealants is the risk of air/gas embolism, due to air/gas entering the vasculature.
Estonian: Ohutuse osas märkis inimravimite komitee, et pihustatavate fibriinliimide peamine risk on õhk/gaasemboolia tekkerisk õhu/gaasi tungimise tõttu veresoontesse.
English: The CHMP therefore concluded that the available evidence supports the efficacy and use of Quixil in the approved indications.
Estonian: Komitee järeldas seepärast, et olemasolevad andmed toetavad Quixili efektiivsust ja kasutamist heakskiidetud näidustustel.
English: • The Committee reviewed all the data provided by the MAH in writing and in the oral explanation and the outcome of the ad-hoc expert advisory group meeting;
Estonian: • komitee tutvus müügiloa hoidja esitatud kirjalike andmete ja suuliste selgituste ning ajutise nõuandva eksperdirühma järeldustega;
English: An ad-hoc expert advisory group meeting was convened in October 2012 at the request of the CHMP, during which the experts discussed the benefits of sprayable fibrin sealants as well as potential risk minimisation measures, in particular with regard to the risk of air embolism.
Estonian: Inimravimite komitee taotlusel toimus 2012. aasta oktoobris ajutise nõuandva eksperdirühma kohtumine, kus eksperdid arutasid pihustatavate fibriinliimide kasulikkust ja võimalikke riskivähendusmeetmeid, eelkõige seoses õhkemboolia riskiga.
English: This case occurred during a clinical trial and highlights the problems with the application of sprayable fibrin sealants during endoscopic procedures, where it is not always feasible to judge distances (such as 4cm) accurately when spraying.
Estonian: Juhtum toimus kliinilisel uuringul ja rõhutab probleemi, mis on seotud pihustatavate fibriinliimide kasutamisega endoskoopiaprotseduuridel, kui alati ei saa hinnata õiget kaugust (nt 4 cm).
English: The CHMP also noted that there appears to be evidence for the need to use the combination spray sealants in situations where there is significant blood loss from a wide surface area and the survival of the patient is threatened.
Estonian: Komitee märkis ka, et näib olevat tõendatud vajadus kasutada kombineeritud pihustatavaid liime olukordades, kus esineb oluline ja patsiendile eluohtlik verejooks suurelt koepinnalt.
English: Therefore the CHMP recommended the variation to the terms of the Marketing Authorisations for the medicinal products referred to in Annex I, in accordance to the amendments to the Summary of Product Characteristics and Package Leaflet set out in Annex III and subject to the conditions set out in Annex IV.
Estonian: Seetõttu soovitas inimravimite komitee muuta I lisas nimetatud ravimite müügilubade tingimusi vastavalt III lisas esitatud ravimi omaduste kokkuvõtte ja pakendi infolehe muudatustele ning IV lisas esitatud müügilubade tingimustele.
English: During the Article 31 procedure, the CHMP also noted a new case of gas embolism reported with the use of Evicel during laser prostatectomy.
Estonian: Artikli 31 kohases menetluses võttis inimravimite komitee teadmiseks ka gaasemboolia uue teatatud juhu, mis oli toimunud Eviceli kasutamisel laserprostatektoomia ajal.
English: With regard to the efficacy of sprayable fibrin sealants, the CHMP assessed the available information, including data submitted by the MAH.
Estonian: Pihustatavate fibriinliimide efektiivsuse osas hindas inimravimite komitee olemasolevat teavet, sh müügiloa hoidjate esitatud andmeid.
English: They were of the opinion that CO2 should be used instead of air as a safety precaution because of the markedly lower risk of gas embolism due to the high solubility of CO2 in the blood.
Estonian: Eksperdid olid arvamusel, et ettevaatusmeetmena tuleks õhu asemel kasutada süsinikdioksiidi (CO2), sest tänu CO2 heale lahustuvusele veres on gaasemboolia risk oluliselt väiksem.
English: In particular, the MAH was requested to submit an EU risk management plan to the national competent authorities which includes the safety concern of gas embolism and to ensure that all users of the spray application are provided with adequate educational material on the correct use of the product and are offered an educational program which teaches the content of the mentioned educational material.
Estonian: Eelkõige nõuti, et müügiloa hoidja esitab riiklikele pädevatele asutustele gaasemboolia ohutusriski Euroopa Liidu riskijuhtimiskava ja tagab, et kõik pihuseid kasutavad arstid saaksid ravimi nõuetekohase kasutamise teabematerjali ja et neile pakutaks võimalust osaleda sellel teabematerjalil põhinevas koolitusprogrammis.
English: The CHMP therefore considered that correct administration of sprayable fibrin sealants is essential to reduce this risk and focused its assessment on the identification of measures that would be necessary and adequate to minimise this risk.
Estonian: Komitee järeldas seepärast, et selle riski vähendamisel on pihustatavaid fibriinliime tingimata vaja manustada nõuetekohaselt, ja keskendus hindamisel eelkõige selle riski minimeerimiseks vajalike ja adekvaatsete meetmete leidmisele.
English: The thrombin component of Evicel is identical to the thrombin component of Quixil but the fibrinogen component of Evicel differs mainly from that of Quixil in the fact that it does not contain tranexamic acid.
Estonian: Eviceli trombiinkomponent on identne Quixili omaga, kuid erineb Quixili omast peamiselt seetõttu, et ei sisalda traneksaamhapet.
English: • The Committee considered all the cases of air embolism associated with the use of Quixil by spray application that have been reported and concluded that the risk minimisation measures previously implemented were insufficient to mitigate the identified risk of air embolism associated with the use of the Quixil spray application;
Estonian: • komitee tutvus kõigi õhkemboolia juhtudega, millest on teatatud seoses Quixili pihustamisega, ja järeldas, et varasematest riskivähendusmeetmetest ei piisanud, et vähendada Quixili pihustamisega seotud tuvastatud õhkembooliariski;
English: The experts agreed that sprayable fibrin sealants are recommended when there is a large surface area of surgical bleeding, generally oozing, and that not using sprayable fibrin sealants in these cases would lead to an increased use of other blood products, which would lead to a higher risk of complications.
Estonian: Eksperdid leidsid, et pihustatavate fibriinliimide kasutamine on soovitatav olukordades, kus esineb kirurgiline (enamasti immitsev) verejooks suurelt koepinnalt ja kus pihustatavatest fibriinliimidest loobumine võib suurendada teiste veretoodete kasutamist koos sellest tuleneva suurema tüsistusriskiga.
English: Finally, the product should only be sprayed using pressurised carbon dioxide gas and with a pressure regulator that caps the maximum pressure at 2.5 bars.
Estonian: Ravimit tohib pihustada ainult survestatud CO2 ja rõhuregulaatori abil, mille maksimaalne rõhk on 2,5 bar.
English: The CHMP pointed out that surgeons and surgical staff should be advised on the appropriate means of achieving a tissue surface that is as dry as possible (e.g. intermittent application of compresses, swabs, use of suction devices).
Estonian: Komitee rõhutas, et kirurgidele ja operatsioonipersonalile tuleb soovitada asjakohaseid meetodeid, millega saavutada enne fibriinliimi kasutamist võimalikult kuiv koepind (nt kompresside, tampoonide vahelduv kasutamine, aspiratsioonivahendid).
English: The CHMP noted that the difference in composition between Quixil and Evicel results in a higher viscosity for Quixil, which in turn has the consequence that more force is required to deliver spray application of Quixil.
Estonian: Inimravimite komitee märkis, et Quixili ja Eviceli koostise erinevus tekitab Quixili suurema viskoossuse, mis omakorda tähendab, et Quixili pihustamisel on vaja suuremat rõhku.
English: The analysis of the case reports showed that symptomatic air/gas embolism had occurred only when the instructions for use were not followed; in each of the other cases there was a failure to follow at least one of the current guidelines on administration of spray application of Quixil using pressurised gas: 1.
Estonian: Juhtude analüüs näitas, et sümptomaatiline õhk- või gaasemboolia tekkis üksnes fibriinliimi kasutusjuhendi eiramisel; kõigil ülejäänud juhtudel ei järgitud Quixili surugaasi abil pihustamisel vähemalt üht nõuet järgmistest:
English: Having considered all the available data, including the MAH responses provided in writing and during oral explanations and the conclusions of the Ad-hoc Expert meeting, the CHMP agreed that the benefitrisk balance of Quixil as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis, remains positive under normal conditions of use, subject to the changes to the product information, (see Annex III), together with the agreed risk minimisation measures (see Annex IV) and the agreed Direct Healthcare Professionals Communication.
Estonian: Pärast tutvumist kõigi olemasolevate andmetega, sealhulgas müügiloa hoidja kirjalike ja suuliste selgituste ning ajutise nõuandva eksperdirühma järeldustega, leidis inimravimite komitee, et Quixili kasulikkuse ja riski suhe kasutamisel täiendava vahendina operatsiooni ajal hemostaasi parandamiseks, kui kirurgilised standardtehnikad ei ole piisavad, on normaalsetel kasutustingimustel endiselt positiivne, kui ravimiteavet muudetakse (vt III lisa), võetakse kokkulepitud riskivähendusmeetmed (vt IV lisa) ja arstidele saadetakse tervishoiutöötajate teatis.
English: The CHMP noted that despite the different recommended pressure regulator settings fibrin sealant spray systems may have similar gas velocity.
Estonian: Komitee märkis, et kuigi rõhuregulaatori soovitatavad seadistused on erinevad, võib gaasi liikumiskiirus pihustussüsteemides olla sarnane.
English: Furthermore, the device design should have a specific gas pressure governor to be used with the spray applicator and with a limit not above the maximal optimal pressure recommended.
Estonian: Peale selle peaks pihustil olema spetsiaalne gaasirõhu regulaator, mida kasutatakse koos pihustusotsakuga, ja rõhupiirik, et ei ületataks maksimaalset soovitatavat gaasirõhku.
English: Use on open vessels or within a highly vascular cavity e.g. bone marrow.
Estonian: Kasutamine avatud veresoontel või suure vaskulariseeritusega õõntes, näiteks luuüdil