FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: • 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;
Slovenian: • 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;
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).
Slovenian: 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).
English: Data has been provided to estimate the oral bioavailability of selenium following ingestion of residues of barium selenate.
Slovenian: Predloženi so bili podatki za oceno peroralne biološke uporabnosti selena po zaužitju ostankov barijevega selenata.
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.
Slovenian: Po trenutnem vedenju odbora CVMP ne obstajajo nobena odobrena dolgo delujoča zdravila za injiciranje, ki vsebujejo barijev selenat, za uporabo pri ciljni vrsti ovac.
English: Oral bioavailability of selenium from barium selenate
Slovenian: Peroralna biološka uporabnost selena iz barijevega selenata
English: The available residue data indicated that there is practically no depletion of barium selenate from the injection site.
Slovenian: Razpoložljivi podatki o ostankih so pokazali, da se barijev selenat praktično ne izloča z mesta injiciranja.
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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: It is administered as a subcutaneous injection at a dose of 1 mg selenium/kg body weight (bw).
Slovenian: Daje se z injiciranjem pod kožo v odmerku 1 mg selena/kg telesne mase.
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.
Slovenian: Ta študija in vitro je pokazala, da je biološko uporabnih najmanj 5 % do 10 % zaužitega selena iz barijevega selenata v običajni mešanici hrane.
English: Risk characterisation
Slovenian: Opredelitev tveganja
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.
Slovenian: 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.
English: • injections containing sodium or potassium selenite, authorised for horses, cattle, sheep and pigs;
Slovenian: • zdravila za injiciranje, ki vsebujejo natrijev ali kalijev selenit in so odobrena za uporabo pri konjih,
English: Grounds for refusal of the granting of the marketing authorisation and for suspension of the existing marketing authorisations
Slovenian: Podlaga za zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom in začasen umik obstoječih dovoljenj
English: 1 mg Se/kg body weight corresponding to the following: Cattle (adult): 6-10 ml
Slovenian: 1 mg Se/kg telesne mase, kot sledi: govedo (odraslo govedo):
English: • 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
Slovenian: • 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;
English: 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.
Slovenian: 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.
English: Estonia Cross Vetpharm Group Limited
Slovenian: Estonija Cross Vetpharm Group Limited Broomhill Road Tallaght
English: In relation to the comments that barium selenate injection sites will be trimmed off and discarded at the slaughter house, the CVMP
Slovenian: 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.
English: Dalmasel L.A. 50 mg/ml, suspensión inyectable para bovino
Slovenian: 50 mg/ml, suspensión inyectable para bovino
English: Belgium Cross Vetpharm Group Limited
Slovenian: Belgija Cross Vetpharm Group Limited Broomhill Road Tallaght,
English: Romania Cross Vetpharm Group Limited
Slovenian: Romunija Cross Vetpharm Group Limited Broomhill Road Tallaght,
English: France Cross Vetpharm Group Limited
Slovenian: Francija Cross Vetpharm Group Limited Broomhill Road Tallaght,
English: Sweden Cross Vetpharm Group Limited
Slovenian: Švedska Cross Vetpharm Group Limited Broomhill Road Tallaght,
English: Latvia Cross Vetpharm Group Limited
Slovenian: Latvija Cross Vetpharm Group Limited Broomhill Road Tallaght,
English: Slovakia Cross Vetpharm Group Limited
Slovenian: Slovaška Cross Vetpharm Group Limited Broomhill Road Tallaght,
English: Spain Cross Vetpharm Group Limited
Slovenian: Španija Cross Vetpharm Group Limited Broomhill Road Tallaght,
English: Co. Kerry
Slovenian: Prod.
English: Poland Cross Vetpharm Group Limited
Slovenian: Poljska Cross Vetpharm Group Limited Broomhill Road Tallaght,
English: Denmark Cross Vetpharm Group Limited
Slovenian: Danska Cross Vetpharm Group Limited Broomhill Road Tallaght,
English: Minor formatting changes were also introduced.
Slovenian: Uvedene so bile tudi manjše spremembe v oblikovanju.
English: Overall summary of the scientific evaluation of Quixil
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Quixil
English: As a result, gas embolism may occur even with a reduced pressure.
Slovenian: Posledično lahko pride do plinske embolije tudi ob znižanem tlaku.
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.
Slovenian: Strokovnjaki so se soglasno strinjali, da tveganje za zračno embolijo ni povezano s samim zdravilom, pač pa z zasnovo pripomočka in njegovo napačno uporabo v praksi.
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;
Slovenian: • Odbor je pregledal vse podatke, ki jih je predložil imetnik dovoljenja za promet v pisni obliki in v obliki ustnega pojasnila, ter zaključke sestanka začasne strokovne svetovalne skupine.
English: Spraying Quixil in endoscopic procedures should therefore be contra-indicated.
Slovenian: Pršenje zdravila Quixil v endoskopskih postopkih mora biti zato kontraindicirano.
English: The fibrinogen component of Quixil also contains tranexamic acid.
Slovenian: Fibrinogenska sestavina zdravila Quixil vsebuje tudi traneksamično kislino.
English: In the same period, 4 cases (of which two had a fatal outcome) were reported following spray application of Evicel, a second generation fibrin sealant, approved via the centralised procedure in 2008.
Slovenian: V enakem obdobju so poročali o štirih primerih (od katerih sta dva imela smrtni izid) ob napršitvi zdravila Evicel, fibrinskega tesnilnega sredstva druge generacije, ki je bilo odobreno po centraliziranem postopku leta 2008.
English: Quixil is a first generation fibrin sealant containing two components, human clottable protein and human thrombin and was approved via the mutual recognition procedure with the UK as reference member state.
Slovenian: Zdravilo Quixil je fibrinsko tesnilno sredstvo prve generacije, ki vsebuje dve sestavini, humani protein, ki koagulira, in humani trombin, ter je bilo odobreno v postopku z medsebojnim priznavanjem, v katerem je bila referenčna država članica Združeno kraljestvo.
English: Finally, the CHMP agreed on a Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review.
Slovenian: Odbor CHMP se je dogovoril tudi o neposrednm obvestilu za zdravstvene delavce (DHPC - Direct Healthcare Professional Communication), da bi jim sporočil izid tega pregleda.
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.
Slovenian: Zdravilo Evicel se je napršilo anterolateralno z regulatorjem tlaka z N2 (dušik) v enkratnem dvosekundnem odmerku na površino, ki je obsegala približno 2½ do 3 centimetre, z znižanim tlakom 8 (osem) PSI.
English: The CHMP agreed that the DHPC should be circulated to all Quixil users in France and Italy, no later than 30 November 2012.
Slovenian: Odbor CHMP se je strinjal, da morajo neposredno obvestilo za zdravstvene delavce prejeti vsi uporabniki zdravila Quixil v Franciji in v Italiji najkasneje do 30. novembra 2012.
English: They also recommended that appropriate educational materials and training for healthcare professionals to administer the product correctly (at the recommended distance and pressure for spray application) is required.
Slovenian: Priporočili so tudi primerno gradivo za izobraževanje in usposabljanje zdravstvenih delavcev za pravilno uporabo zdravila (ob priporočeni razdalji in tlaku za napršitev).
English: It can be either dripped onto the tissue or sprayed onto the tissue in short bursts.
Slovenian: Zdravilo se bodisi nakapa ali naprši na tkivo v majhnih odmerkih.
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.
Slovenian: Glede na navedeno je Evropska komisija 21. maja 2012 začela postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, v katerem je Odbor za zdravila za uporabo v humani medicini (CHMP) pozvala, naj prouči zgornje pomisleke in njihov vpliv na razmerje med koristmi in tveganji za zdravilo Evicel ter predloži svoje mnenje o ukrepih, potrebnih za zagotavljanje varne in učinkovite uporabe zdravila Evicel in o tem, ali se lahko dovoljenje za promet za to zdravilo ohrani ali pa ga je treba spremeniti, začasno umakniti oziroma preklicati.
English: The pressure range for Quixil is therefore higher (2.0-2.5 bar) compared with that of Evicel (1.0-1.7 bar).
Slovenian: Območje tlaka je tako pri zdravilu Quixil višje (2,0−2,5 bara) kot območje tlaka pri zdravilu Evicel (1,0−1,7 bara).
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je potrdil, da je maja 2012 v Evropi prenehal dobavljati zdravilo Quixil in da je majhno število enot zdravila Quixil na voljo še v Franciji in Italiji.
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.
Slovenian: Menili so, da je treba kot varnostni ukrep za bistveno nižje tveganje plinske embolije namesto zraka uporabiti CO2, saj ima CO2 večjo topnost v krvi.
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).
Slovenian: Kljub ukrepom za zmanjšanje tveganja, ki so bili sprejeti med avgustom 2010 in začetkom leta 2011 za zdravili Quixil in Evicel, vključno z: 1) neposrednim obvestilom zdravstvenim delavcem glede sprememb v označevanju zdravila, 2) obvestilom o varnosti v praksi za regulator tlaka, vključno z navodili za uporabo in 3) posodobljenimi programi usposabljanja strank, so po napršitvi zdravila Evicel poročali o dveh novih primerih zračne embolije (en primer z nesmrtnim izidom avgusta 2011 in primer s smrtnim izidom januarja 2012) (med postopkom napotitve pa so poročali še o tretjem primeru).
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.
Slovenian: Potem je regulativna agencija Združenega kraljestva za zdravila 24. maja 2012 sprožila postopek v skladu s členom 31, s katerim je odbor CHMP zaprosila, naj opravi enako presojo za druga fibrinska tesnilna sredstva, ki so na voljo v EU, vključno z zdravilom Quixil.
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.
Slovenian: Zato je menil, da je pravilna uporaba fibrinskih tesnilnih sredstev nujna za zmanjšanje tega tveganja in svojo presojo usmerila na določanje ukrepov, potrebnih in zadostnih za zmanjšanje tega tveganja na najnižjo raven.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC fibrinogencontaining solutions for sealant authorised for administration by spray application, including Quixil;
Slovenian: • Odbor je upošteval postopek v skladu s členom 31 Direktive 2001/83/ES o tesnilnih raztopinah, ki vsebujejo fibrinogen, odobrenih za uporabo s pršenjem, vključno z zdravilom Quixil.
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.
Slovenian: Ne nazadnje se lahko zdravilo naprši le z ogljikovim dioksidom pod tlakom in z regulatorjem tlaka, ki omeji najvišji tlak na 2,5 bara.
English: Clear instructions to surgeons with regard to the distances and pressures recommended and the pressurised gas to be used should be provided and the use should be restricted to experienced surgeons who have been trained in the use of Quixil.
Slovenian: Kirurgom je treba dati jasna navodila glede priporočenih razdalj in tlakov ter plina pod tlakom, ki naj ga uporabljajo, uporaba zdravila pa mora biti omejena na izkušene kirurge, ki so bili usposobljeni za uporabo zdravila Quixil.
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.
Slovenian: Med postopkom v skladu s členom 31 je Odbor opozoril tudi na nov primer plinske embolije, o katerem so poročali pri zdravilu Evicel med lasersko prostatektomijo.
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.
Slovenian: Poleg tega je treba pripomoček zasnovati s posebnim krmilnikom plinskega tlaka, ki bi se uporabljal s pršilnikom in z omejitvijo, ki ne bi presegla najvišjega priporočenega optimalnega tlaka.
English: The CHMP revised the Quixil PI accordingly, to ensure the safe and effective use of Quixil (see Annex III).
Slovenian: Odbor CHMP je v skladu s tem pregledal informacije o zdravilu Quixil, da bi zagotovil varno in učinkovito uporabo zdravila Quixil (glejte Prilogo III).
English: • The CHMP agreed on a number of additional risk minimisation measures, including changes to the product information regarding the use of the product as well as educational materials and training to be provided to users of the product, which adequately addressed the identified risk of air embolism;
Slovenian: • CHMP je soglašal s številnimi dodatnimi ukrepi za zmanjšanje tveganja, vključno s spremembami informacij o zdravilu glede uporabe zdravila ter tudi z izobraževalnim gradivom in usposabljanjem, ki se morajo zagotoviti za uporabnike zdravila, v katerih bo ustrezno obravnavano ugotovljeno tveganje za zračno embolijo.
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.
Slovenian: Do tega primera je prišlo med kliničnim preskušanjem in izpostavlja težave ob uporabi fibrinskih tesnilnih sredstev v pršilu med endoskopskimi postopki, kadar ni vedno mogoče natančno oceniti razdalj (kot npr. 4 cm) med pršenjem.
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.
Slovenian: Glede varnosti je poudaril, da je glavno tveganje pri fibrinskih tesnilnih sredstvih v pršilu tveganje za zračno/plinsko embolijo zaradi zraka/plina, ki vstopi v ožilje.
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.
Slovenian: Na zahtevo odbora CHMP je bil v oktobru 2012 sklican sestanek začasne strokovne svetovalne skupine, na katerem so strokovnjaki razpravljali o koristih fibrinskih tesnilnih sredstev v pršilu ter o ukrepih za zmanjšanje možnih tveganj, še zlasti tveganja za zračno embolijo.
English: The CHMP therefore concluded that the available evidence supports the efficacy and use of Quixil in the approved indications.
Slovenian: Zato je sklenil, da razpoložljivi dokazi podpirajo učinkovitost in uporabo zdravila Quixil za odobrene indikacije.
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).
Slovenian: Odbor CHMP je izpostavil, da je treba kirurge in kirurško osebje seznaniti z ustreznimi načini doseganja čim bolj suhe površine tkiva (npr. z uporabo kompres, tamponov ali uporabo sesalnih naprav med postopkom).
English: Appropriate means of achieving a tissue surface that is as dry as possible should be used and changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored during application of Quixil by spray because of the possibility of occurrence of air or gas embolism.
Slovenian: Uporabiti je treba ustrezne načine za doseganje čim bolj suhe površine tkiva, med pršenjem zdravila Quixil pa je treba spremljati spremembe v krvnem tlaku, srčnem utripu, nasičenosti s kisikom ter CO2 v izdihanem zraku ob koncu izdiha zaradi možnega pojava zračne ali plinske embolije.
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.
Slovenian: Trombinska sestavina zdravila Evicel je identična trombinski sestavini zdravila Quixil, vendar se fibrinogenska sestavina zdravila Evicel od fibrinogenske v zdravilu Quixil razlikuje predvsem v tem, da ne vsebuje traneksamične kisline.
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.
Slovenian: Strokovnjaki so se strinjali, da je uporaba fibrinskih tesnilnih sredstev v pršilu priporočljiva pri kirurških krvavitvah velike površine z mezenjem krvi, kadar bi neuporaba fibrinskih tesnilnih sredstev v pršilu povzročila povečano uporabo drugih krvnih produktov, kar bi povečalo tveganje za zaplete.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil zlasti naprošen, naj pristojnim nacionalnim organom predloži strategijo obvladovanja tveganja na ravni EU, kar vključuje varnostni zadržek glede plinske embolije in zagotovi, da bodo vsi uporabniki zdravila v pršilu prejeli ustrezno izobraževalno gradivo o pravilni uporabi zdravila ter jim bo bo omogočen dostop do programa usposabljanja, v okviru katerega bodo poučeni o vsebini navedenega izobraževalnega gradiva.