FrancophonIA/ELRC3.0 huggingface dataset:
English: In the CVMP MRL summary report a figure of 0.6 mg selenium/person/day was at the time considered appropriate.
Maltese: Fir-rapport tas-sommarju tal-MRL tas-CVMP il-figura ta' 0.6 mg ta' selenju/persuna/kuljum dak iż-żmien kienet meqjusa adegwata.
English: Soc. Anim.
Maltese: Mnejn għandu jingħata
English: Poland Cross Vetpharm Group Limited
Maltese: Il-Polonja Cross Vetpharm Group Limited
English: The risk mitigation measures used at present are not suitable to prevent consumer risk for the reasons described above.
Maltese: Il-miżuri ta' mitigazzjoni tar-riskju attwalment użati mhumiex adatti biex jiġi evitat ir-riskju għall-konsumatur għar-raġunijiet deskritti hawn fuq.
English: 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.
Maltese: Meta wieħed iqis il-benefiċċju għas-saħħa tal-annimal fil-prevenzjoni u l-kura ta' defiċjenzi ta' selenju kontra r-riskju għas-saħħa pubblika permezz ta' residwi fl-ikel, il-bilanċ tal-benefiċċju-riskju għal prodotti mediċinali veterinarji injettabbli li jaġixxu fit-tul li fihom selenat tal-barju huwa meqjus negattiv.
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.
Maltese: • is-sistemi ta' farmakoviġilanza se jkunu mistennija jiskopru avvenimenti avversi serji b'riżultat talkonsum ta' laħam li fih residwi ta' selenat tal-barju; il-fatt li l-ebda avveniment bħal dan ma ġie skopert jappoġġja l-konklużjoni li s-siti tal-injezzjoni ta' selenat tal-barju mhumiex ta' periklu għassigurtà tal-konsumatur.
English: Latvia Cross Vetpharm Group Limited
Maltese: Il-Latvja Cross Vetpharm Group Limited
English: 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.
Maltese: Wara li rreveda d-dokumentazzjoni kollha sottomessa mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, is-CVMP ikkonkluda li ma kienx hemm biżżejjed raġunijiet xjentifiċi biex ibiddel ilkonklużjonijiet ġenerali tal-10 ta' April 2013, li kkonkludew li l-bilanċ tal-benefiċċju-riskju għall-prodotti kkonċernati huwa negattiv u li dawn il-prodotti mediċinali veterinarji jistgħu joħolqu theddida sinifikanti għas-saħħa tal-bniedem minħabba residwi persistenti ta' selenju fis-sit tal-injezzjoni.
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;
Maltese: • is-CVMP qies li attwalment ma hemm l-ebda miżura għall-ġestjoni tar-riskju fis-seħħ biex jiġu evitati residwi fis-sit tal-injezzjoni u ma setgħux jiġu identifikati f'din il-proċedura minħabba nuqqas ta' informazzjoni u tagħrif biżżejjed biex miżuri bħal dawn jiġu vvalutati;
English: Suitable risk mitigation measures have to be proposed and supported by appropriate scientific data which demonstrate that selenium residues in edible tissues from treated animals, including the injection site, exceeding the upper tolerable intake value of 0.3 mg/person/day do not enter the food chain.
Maltese: Miżuri adegwati għall-mitigazzjoni tar-riskju għandhom jiġu proposti u appoġġati minn dejta xjentifika adegwata li turi li r-residwi ta' selenju f'tessuti li jistgħu jittieklu li ġew minn annimali li rċevew kura, inkluż is-sit tal-injezzjoni, li jaqbżu l-valur massimu tollerabbli ta' konsum ta' 0.3 mg/persuna/kuljum ma jidħlux fil-katina tal-ikel.
English: Belgium Cross Vetpharm Group Limited
Maltese: Il-Belġju Cross Vetpharm Group Limited
English: Furthermore, while it is the case that the ADI is based on repeated exposure, the alternative threshold proposed by the marketing authorisation holders (i.e. the LD50) is not appropriate as this represents the value at which 50% mortality is expected.
Maltese: Barra minn hekk, filwaqt li huwa l-każ li l-ADI huwa bbażat fuq esponiment ripetut, il-limitu alternattiv propost mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (jiġifieri l-LD50) mhijiex adegwata peress li din tirrappreżenta l-valur li bih hija mistennija mortalità ta' 50%.
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.
Maltese: Għalhekk, is-CVMP irrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq eżistenti tal-prodotti mediċinali veterinarji injettabbli kollha li jaġixxu fit-tul li fihom selenat tal-barju sakemm tiġi pprovduta dejta li tiżgura s-sigurtà għall-konsumatur wara l-użu tal-prodotti.
English: 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.
Maltese: Barra minn hekk, il-bażi tad-dejta għall-valutazzjoni talbijodisponibilità orali ta' selenju minn selenat tal-barju u t-teħid u l-passaġġi ta' tossiċità possibbli tiegħu wara inġestjoni orali saret aktar kompluta u dejta addizzjonali dwar tossiċità akuta b'selenju, speċjalment fil-bnedmin, saret disponibbli.
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).
Maltese: is-CVMP irrakkomanda r-rifjut tal-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq u għas-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq eżistenti għall-formulazzjonijiet li jaġixxu fit-tul għallinjezzjonijiet li fihom selenat tal-barju għall-ispeċi kollha li jipproduċu l-ikel (ara anness I).
English: Scientific Discussion
Maltese: Diskussjoni xjentifika
English: The CHMP agreed that the DHPC should be circulated to all Quixil users in France and Italy, no later than 30 November 2012.
Maltese: Is-CHMP qabel li d-DHPC għandha tiġi ċċirkolata lill-utenti kollha ta' Quixil fi Franza u fl-Italja, sa mhux aktar tard mit-30 ta' Novembru 2012.
English: The pressure range for Quixil is therefore higher (2.0-2.5 bar) compared with that of Evicel (1.0-1.7 bar).
Maltese: Il-firxa tal-pressjoni għal Quixil hija għalhekk ogħla (2.0-2.5 bar) apparagun ma' dik ta' Evicel (1.01.7 bar).
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).
Maltese: Minkejja attivitajiet ta' mitigazzjoni tar-riskji stabbiliti bejn Awwissu 2010 u kmieni fl-2011 għal Quixil u Evicel, inklużi: 1) komunikazzjoni diretta lill-professjonisti tal-kura tas-saħħa dwar tibdil fittikketti tal-prodott, 2) notifika ta' sikurezza fuq il-post għar-regolatur tal-pressjoni inkluż tibdil flistruzzjonijiet għall-użu, u 3) programmi aġġornati ta' taħriġ għall-klijenti, żewġ każi ġodda ta' emboliżmu tal-arja (u t-tielet każ matul il-proċedura ta' riferiment) ġew irrapportati wara l-użu talapplikazzjoni ta' Evicel bħala sprej (każ wieħed mhux fatali f'Awwissu 2011 u każ fatali f'Jannar 2012).
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;
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal soluzzjonijiet li fihom fibrinogen għal siġillanti awtorizzati għall-għoti b'applikazzjoni bħala sprej, inkluż Quixil;
English: The CHMP noted that despite the different recommended pressure regulator settings fibrin sealant spray systems may have similar gas velocity.
Maltese: Is-CHMP innota li minkejja s-settings differenti rakkomandati għar-regolatur tal-pressjoni, sistemi ta' siġillanti tal-fibrina bħala sprej jista' jkollhom veloċità simili tal-gass.
English: Overall summary of the scientific evaluation of Quixil
Maltese: Konklużjonijiet xjentifiċi
English: The fibrinogen component of Quixil also contains tranexamic acid.
Maltese: Il-komponent ta' fibrinogen ta' Quixil fih ukoll l-aċidu traneksamiku.
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.
Maltese: Il-komponent ta' trombina ta' Evicel huwa identiku għall-komponent ta' trombina ta' Quixil imma l-komponent ta' fibrinogen ta' Evicel prinċipalment ivarja minn dak ta' Quixil fil-fatt li ma fihx aċidu traneksamiku.
English: Quixil is indicated as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.
Maltese: Quixil huwa indikat bħala kura ta' appoġġ f'kirurġija fejn tekniki kirurġiċi standard ma jkunux biżżejjed, għat-titjib tal-emostażi.
English: Benefit Risk balance
Maltese: Bilanċ tal-Benefiċċju u tar-Riskju
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.
Maltese: Matul il-proċedura skont l-Artikolu 31, is-CHMP innota wkoll każ ġdid ta' emboliżmu tal-gass irrapportat bl-użu ta' Evicel matul prostatektomija bil-lejżer.
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.
Maltese: Wara li kkunsidra d-dejta kollha disponibbli, inkluż it-tweġibiet tad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovduti bil-miktub u waqt spjegazzjonijiet orali u l-konklużjonijiet tal-laqgħa tal-Esperti Ad-hoc, is-CHMP qabel li l-bilanċ tal-benefiċċju-riskju ta' Quixil bħala kura ta' appoġġ f'kirurġija fejn tekniċi kirurġiċi standard mhumiex biżżejjed, għat-titjib tal-emostasi, jibqa' pożittiv taħt kundizzjonijiet normali ta' użu, soġġett għat-tibdil għall-informazzjoni dwar il-prodott, (ara Anness III), flimkien mal-miżuri ta' minimizzazzjoni tar-riskju miftiehma (ara Anness IV) u lKomunikazzjoni Diretta lill-Professjonali tal-Kura tas-Saħħa miftiehma.
English: The CHMP revised the Quixil PI accordingly, to ensure the safe and effective use of Quixil (see Annex III).
Maltese: Is-CHMP irreveda linformazzjoni dwar il-prodott ta' Quixil kif xieraq, biex jiġi żgurat l-użu sigur u effettiv ta' Quixil (ara Anness III).
English: In addition, the MAH should ensure that all users of the spray application of this product are provided with labels for the pressure regulator that inform about the correct pressure and distance in open surgery, a warning card that informs about the correct pressure and distance for the spray application for open surgery and a yellow tag, to be placed on the device air hose, which provides instructions for use.
Maltese: Barra minn hekk, id-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li l-utenti kollha tal-applikazzjoni ta' dan ilprodott bħala sprej jiġu pprovduti b'tikketti għar-regolatur tal-pressjoni li jinformaw dwar il-pressjoni u d-distanza korretta f'kirurġija miftuħa, tabella ta' twissija li tinforma dwar il-pressjoni u d-distanza korretta għall-applikazzjoni bħala sprej għal kirurġija miftuħa u tikketta safra, li għandha titqiegħed fuq il-pajp tal-arja tal-apparat, li tipprovdi istruzzjonijiet għall-użu.
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;
Maltese: • Il-Kumitat irreveda d-dejta kollha pprovduta mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq bil-miktub u fl-ispjegazzjoni orali u r-riżultat tal-laqgħa tal-grupp konsultattiv espert ad-hoc;
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.
Maltese: Fl-aħħarnett, il-prodott għandu jiġi sprejjat biss b'dijossidu tal-karbonju taħt pressjoni u b'regolatur tal-pressjoni li jillimita lpressjoni massima f'2.5 bars.
English: Finally, the CHMP agreed on a Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review.
Maltese: Fl-aħħarnett, is-CHMP qabel fuq Komunikazzjoni Diretta lill-Professjonisti tal-Kura tas-Saħħa (DHPC), biex jikkomunika r-riżultat tar-reviżjoni attwali.
English: In conclusion, having considered the available data, the MAH's responses and taking into account the ad-hoc advisory group recommendations, the CHMP identified and agreed upon a number of risk minimisation measures to be implemented by the MAH to reduce the risk of air/gas embolism associated with sprayable fibrin sealants.
Maltese: Bħala konklużjoni, wara li kkunsidra d-dejta kollha disponibbli, it-tweġibiet tad-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq u b'kunsiderazzjoni tar-rakkomandazzjonijiet tal-grupp konsultattiv ad-hoc, is-CHMP identifika u qabel dwar għadd ta' miżuri ta' minimizzazzjoni tar-riskju biex jiġu implimentati mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq biex jitnaqqas ir-riskju ta' emboliżmu tal-gass/arja assoċjat mal-użu ta' siġillanti tal-fibrina li jistgħu jiġi sprejjati.
English: With regard to the efficacy of sprayable fibrin sealants, the CHMP assessed the available information, including data submitted by the MAH.
Maltese: Fir-rigward tal-effikaċja ta' siġillanti tal-fibrina li jistgħu jiġi sprejjati, is-CHMP evalwa l-informazzjoni disponibbli, inkluż dejta sottomessa mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH).
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.
Maltese: Fl-istess perjodu, kienu rrapportati 4 każi (li minnhom tnejn kellhom riżultat fatali) wara l-applikazzjoni bħala sprej ta' Evicel, siġillant tal-fibrina tat-tieni ġenerazzjoni, approvat permezz tal-proċedura ċentralizzata fl-2008.
English: The CHMP reviewed all cases of gas embolism reported with the use of sprayable fibrin sealants.
Maltese: Is-CHMP irreveda l-każi kollha ta' emboliżmu tal-gass irrapportati bl-użu ta' siġillanti tal-fibrina li jistgħu jiġi sprejjati.
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.
Maltese: Fir-rigward tas-sigurtà s-CHMP innota li r-riskju ewlieni b'siġillanti tal-fibrina li jistgħu jiġi sprejjati huwa r-riskju ta' emboliżmu tal-arja/gass, minħabba l-arja/gass li jidħol fil-vaskulatura.
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;
Maltese: • Il-Kumitat ikkunsidra l-każijiet kollha ta' emboliżmu tal-arja assoċjati mal-użu ta' Quixil permezz ta' applikazzjoni bħala sprej li ġew irrapportati u kkonkluda li l-miżuri ta' minimizzazzjoni tarriskju implimentati qabel ma kinux biżżejjed biex itaffu r-riskju identifikat ta' emboliżmu tal-arja assoċjat mal-użu tal-applikazzjoni ta' Quixil bħala sprej;
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.
Maltese: Quixil huwa siġillant tal-fibrina tal-ewwel ġenerazzjoni li fih żewġ komponenti, proteina umana li tgħaqqad u trombina umana.
English: Moreover, the CHMP concluded that there was insufficient evidence to substantiate a higher risk of air embolus for Quixil (relative to Evicel) because of the different pressure range required for Quixil.
Maltese: Barra dan, is-CHMP ikkonkluda li ma kienx hemm biżżejjed evidenza biex tissostanzja riskju ogħla ta' embolu tal-arja għal Quixil (relattiv għal Evicel) minħabba l-firxa differenti tal-pressjoni meħtieġa għal Quixil.
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.
Maltese: Wara dan l-Aġenzija Regolatorja tal-Mediċini u tal-prodotti għall-Kura tas-Saħħa tar-Renju Unit nediet proċedura skont l-Artikolu 31 fl-24 ta' Mejju 2012, fejn talbet lis-CHMP jagħmel l-istess valutazzjoni għas-siġillanti l-oħra tal-fibrina disponibbli fl-UE, inkluż Quixil.
English: If spraying is required, a pressure regulator has to be used with pressurized CO2 or compressed air. From 2008 until May 2012, four cases of life-threatening air embolism were reported for the spray application of Quixil (of which one had a fatal outcome but without any product being administered).
Maltese: Mill-2008 sa Mejju 2012 ġew irrapportati erba' każi ta' emboliżmu tal-arja ta' periklu għall-ħajja blapplikazzjoni ta' Quixil bħala sprej (li wieħed minnhom kellu riżultat fatali imma bla ma kien ingħata l-ebda prodott).
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.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ikkonforma li t-trasbord ta' Quixil fl-Ewropa kien waqaf f'Mejju 2012 u li kien hemm biss ftit unitajiet ta' Quixil disponibbli fi Franza u fl-Italja.
English: • The Committee, as a consequence, concluded that the benefit-risk balance of Quixil as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis, is positive under normal conditions of use, subject to the agreed risk minimisation measures, including changes to the product information.
Maltese: • Il-Kumitat, bħala konsegwenza, ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' Quixil bħala kura ta' appoġġ f'kirurġija fejn tekniċi kirurġiċi standard mhumiex biżżejjed, għat-titjib tal-emostasi, huwa pożittiv taħt kundizzjonijiet normali ta' użu, soġġett għall-miżuri ta' minimizzazzjoni tarriskju miftiehma, inkluż tibdil fl-informazzjoni dwar il-prodott.
English: As a result, gas embolism may occur even with a reduced pressure.
Maltese: Bħala riżultat emboliżmu tal-gass jista' jseħħ anke bi pressjoni mnaqqsa.
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.
Maltese: F'Ottubru 2012, fuq talba tas-CHMP, tlaqqgħet laqgħa tal-grupp konsultattiv espert ad-hoc, li matulha l-esperti ddiskutew il-benefiċċji ta' siġillanti tal-fibrina li jistgħu jiġu sprejjati kif ukoll miżuri potenzjali ta' minimizzazzjoni tar-riskju, b'mod partikulari fir-rigward tar-riskju ta' emboliżmu talarja.
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.
Maltese: Għandhom jintużaw mezzi xierqa biex jinkiseb wiċċ tat-tessut xott kemm jista' jkun u tibdil fil-pressjoni tad-demm, il-polz, is-saturazzjoni talossiġenu u l-end tidal CO2 għandhom jiġu mmonitorjati matul l-applikazzjoni ta' Quixil permezz ta' sprej minħabba l-possibbiltà tal-okkorrenza ta' emboliżmu tal-arja jew tal-gass.
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.
Maltese: B'mod partikolari, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq intalab jissottometti pjan għallġestjoni tar-riskju tal-UE lill-awtoritajiet nazzjonali kompetenti li jinkludi t-tħassib dwar is-sigurtà ta' emboliżmu tal-gass u biex jiżgura li l-utenti kollha tal-applikazzjoni bħala sprej jiġu pprovduti b'materjal edukattiv adegwat dwar l-użu korrett tal-prodott u jiġu offruti programm edukattiv li jgħallem il-kontenut tal-materjal edukattiv imsemmi.
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;
Maltese: • Il-Kumitat qabel fuq għadd ta' miżuri addizzjonali ta' minimizzazzjoni tar-riskju, inkluż tibdil flinformazzjoni dwar il-prodott dwar l-użu tal-prodott kif ukoll materjal edukattiv u taħriġ li għandu jiġu pprovdut lill-utenti tal-prodott, li b'mod adegwat jindirizzaw ir-riskju identifikat ta' emboliżmu tal-arja;
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.
Maltese: Dan il-każ seħħ waqt prova klinika u jenfasizza l-problemi bl-applikazzjoni ta' siġillanti tal-fibrina li jistgħu jiġu sprejjati matul proċeduri endoskopiċi, fejn ma jkunx dejjem possibbli li d-distanzi jiġu ġġudikati (eż 4ċm) b'mod preċiż waqt lisprejjar.
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.
Maltese: L-esperti qablu li siġillanti tal-fibrina li jistgħu jiġu sprejjati huma rakkomandati meta jkun hemm superfiċje kbira ta' fsada kirurġika, li ġeneralment tkun qed tnixxi, u li jekk f'dawn il-każijiet ma jintużawx siġillanti tal-fibrina li jistgħu jiġu sprejjati dan iwassal għal żieda fl-użu ta' prodotti oħra tad-demm, li jwassal għal riskju ogħla ta' komplikazzjonijiet.