FrancophonIA/ELRC3.0 huggingface dataset:
English: NA No dose adjustment needed for abacavir or lamivudine when administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Slovenian: Prilagoditev odmerka abakavirja ali lamivudina ni potrebna, kadar se sočasno daje s kombinacijo dasabuvir + ombitasvir/paritap revir/ritonavir.
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir aprevir/ ritonavi r ombitasvir
Slovenian: Zavrtje CYP3A4 z ritonavirjem dasabuvir ombitasvir/ paritaprevi r/ritonavir
English: What you need to know before you take Exviera 3.
Slovenian: Kaj je zdravilo Exviera in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Exviera Kako jemati zdravilo Exviera
English: Mechanism: OATP1B/BC RP inhibition by paritaprevir.
Slovenian: OATP1B/BCRP s paritaprevirjem.
English: Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Slovenian: Zdravljeni preiskovanci (N = 305) so bili mediano stari 54 let (razpon: od 19 do 70); 65,2 % je bilo moških; 11,8 % je bilo črncev; 20,7 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 86,6 %
English: Rilpivirine exposure is substantially increased (3-fold) when rilpivirine is given in combination with dasabuvir with ombitasvir/paritaprevir/ritonavir, with a consequent potential for QT-prolongation.
Slovenian: se izpostavljenost rilpivirinu bistveno zveča (3-krat) in posledično se lahko pojavi podaljšanje QT.
English: Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir.
Slovenian: Zavrtje OATP1B s paritaprevirjem in zavrtje BCRP z dasabuvirjem, paritaprevirjem in ritonavirjem.
English: No dose adjustment needed for dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Slovenian: Prilagoditev odmerka ni potrebna za kombinacijo dasabuvir + ombitasvir/paritap revir/ritonavir.
English: Phenytoin
Slovenian: fenobarbital
English: ombitasvir/paritaprevir/ritonavir with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
Slovenian: randomizirano, globalno multicentrično, odprto Zdravljenje: ombitasvir/paritaprevir/ritonavir z ali brez dasabuvirja, z ali brez ribavirina, odmerjenega glede na telesno maso, 12 ali 24 tednov
English: 30 mg once daily single dose3
Slovenian: IMUNOSUPRESIVI ciklosporin Posamezen odmerek 30 mg enkrat na dan 3
English: ↑ levothyroxine
Slovenian: ↑ fluvastatin ↑ pitavastatin
English: Nevirapine etravirine dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Slovenian: ↑ paritaprevir darunavir dasabuvir ombitasvir/ paritaprevi r/ritonavir
English: Sulfamethoxazole, trimethoprim
Slovenian: AUC Ctrough Klinične opombe sulfametoksazol, trimetoprim
English: No dose adjustment needed for dolutegravir when administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Slovenian: Prilagoditev odmerka dolutegravirja ni potrebna, kadar se sočasno daje s kombinacijo dasabuvir + ombitasvir/paritap revir/ritonavir.
English: The dosing recommendations in Table 1 should be followed.
Slovenian: Sočasna okužba s HIV-1 Upoštevati je treba navodila za odmerjanje v preglednici 1.
English: dasabu vir + ombitas vir/parit aprevir/ ritonavi r everolimus
Slovenian: dasabuvir ombitasvir/ paritaprevi r/ritonavir everolimus
English: NA No dose adjustment required for carisoprodol; increase dose if clinically indicated.
Slovenian: NP Prilagoditev odmerka karisoprodola ni potrebna;
English: Without cirrhosis
Slovenian: Brez ciroze
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Slovenian: jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 15,4 % jih je imelo portalno fibrozo (F2) in 8,7 % jih je imelo fibrozo z mostiči (F3); 67,7 % jih je imelo okužbo s HCV genotipa 1a; 32,3 % jih je imelo okužbo s HCV genotipa 1b.
English: Diazepam2 mg single dose
Slovenian: Posamezen odmerek 2 mg
English: • Diarrhoea
Slovenian: • bruhanje.
English: The EC50 of dasabuvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 7.7 and 1.8 nM, respectively.
Slovenian: 7,7 nM in proti sevu genotipa 1b-Con1 1,8 nM.
English: Potential for other medicinal products to affect the pharmacokinetics of dasabuvir
Slovenian: Vpliv predhodnega zdravljenja z dasabuvirjem,
English: Fluvastatin
Slovenian: omeprazol
English: ombitas vir/parit aprevir/r itonavir
Slovenian: ombitasvir/ paritaprevi r/ritonavir
English: ↔ digoxin 1.15
Slovenian: ↔ R-metadon 1,04
English: Axumin fluciclovine (
Slovenian: Axumin fluciklovin (
English: The side effects seen with the product are mild and rare, and there are no serious safety risks.
Slovenian: Neželeni učinki, opaženi pri zdravilu, so redki in blagi, resnih varnostnih tveganj pa ni.
English: The full EPAR for Axumin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Axumin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Axumin?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Axumin?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Axumin's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Axumin večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Axumin.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Axumin.
English: Other information about Axumin
Slovenian: Druge informacije o zdravilu Axumin
English: The most common side effects with Axumin (seen in between 1 and 10 patients in 100) are taste disturbances, altered sense of smell, and pain or rash at the site of injection.
Slovenian: Najpogostejši neželeni učinki zdravila Axumin (opaženi pri 1 do 10 bolnikih od 100) so motnje v zaznavanju okusa, spremenjen čut za vonj in bolečina ali izpuščaj na mestu injiciranja.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Axumin have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Axumin upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Axumin is a ‘radiopharmaceutical': it contains the active substance fluciclovine (18F), which emits a small amount of radiation.
Slovenian: Zdravilo Axumin je „radiodiagnostično“: vsebuje zdravilno učinkovino fluciklovin (18F), ki oddaja majhno količino radioaktivnega sevanja.
English: For more information about treatment with Axumin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Axumin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The active substance in Axumin, fluciclovine (18F), works by entering prostate cancer cells via structures (LAT-1 and ASCT2) that are present in high numbers on the surface of these cells.
Slovenian: Zdravilna učinkovina v zdravilu Axumin, fluciklovin (18F), oddaja majhno količino radioaktivnega sevanja in deluje tako, da v celice raka prostate vstopi skozi strukture (LAT-1 in ASCT2), ki so na površini teh celic prisotne v velikem številu.
English: PET scans with Axumin are effective in detecting prostate cancer and can help exclude the presence of the cancer.
Slovenian: Slikanje s PET z zdravilom Axumin je učinkovito pri zaznavanju raka prostate in lahko pomaga pri izključevanju prisotnosti raka.
English: All men enrolled in this study had already shown some signs that the cancer might have returned, such as increases in blood levels of PSA, a protein produced in the prostate glands.
Slovenian: Vsi moški v tej študiji so imeli določene znake, ki so kazali, da se je rak morda ponovno pojavil, npr. zvišane krvne ravni prostatičnega specifičnega antigena (PSA), beljakovine, ki nastaja v prostati.
English: Axumin delivers a very low amount of radiation which could pose a very low risk of cancer and hereditary abnormalities.
Slovenian: Zdravilo Axumin oddaja zelo majhno količino radioaktivnega sevanja, ki lahko predstavlja zelo nizko tveganje za nastanek raka in razvoj dednih okvar.
English: What benefits of Axumin have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Axumin izkazalo v študijah?
English: It is not intended to provide practical advice on how to use Axumin.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For the full list of side effects and restrictions reported with Axumin, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Axumin, glejte navodilo za uporabo.
English: Axumin is available as a solution for injection, which is given as a single injection into a vein around 3 to 5 minutes before the patient is to undergo a PET scan.
Slovenian: Zdravilo Axumin je na voljo v obliki raztopine za injiciranje, ki se vbrizga v žilo od 3 do 5 minut pred slikanjem bolnika s PET.
English: What are the risks associated with Axumin?
Slovenian: Kakšna tveganja so povezana z zdravilom Axumin?
English: What is Axumin and what is it used for?
Slovenian: Kaj je zdravilo Axumin in za kaj se uporablja?
English: It is used specifically with the body scan known as positron-emission tomography (PET) in men whose blood test for prostate-specific antigen (PSA) indicate that the cancer may have returned.
Slovenian: Uporablja se izrecno pri slikanju telesa, imenovanem pozitronska emisijska tomografija (PET), pri moških, pri katerih krvna preiskava prostatičnega specifičnega antigena (PSA) pokaže možno prisotnost raka.
English: Why is Axumin approved?
Slovenian: Zakaj je bilo zdravilo Axumin odobreno?
English: For practical information about using Axumin, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Axumin naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Once inside the cancer cells, it emits radiation which is detected on the PET scan, enabling doctors to see where the cancer is located.
Slovenian: Ko pride v notranjost rakavih celic, oddaja radioaktivno sevanje, ki ga slikanje s PET zazna, zato zdravniki lahko vidijo mesto, kjer je prisoten rak.
English: In a main study involving medical records from 115 men, PET scans with Axumin correctly detected cancers in 99% of all patients whose cancer had in fact returned (as confirmed by tissue sampling).
Slovenian: V glavni študiji, ki je vključevala zdravstvene kartoteke 115 moških, je slikanje s PET z zdravilom Axumin v 79 % pravilno pokazalo ponovno pojavitev raka, kar je bilo naknadno potrjeno z laboratorijskimi študijami tkiva.
English: Axumin is a diagnostic medicine used with a body scan to check whether or not prostate cancer has returned.
Slovenian: Zdravilo Axumin je diagnostično zdravilo, ki se uporablja pri slikanju telesa za odkrivanje ponovne pojavitve raka prostate.
English: Furthermore, the risk from radiation is very low.
Slovenian: Poleg tega je tveganje zaradi radioaktivnega sevanja zelo nizko, zdravnikom pa je svetovano, da uporabljajo najnižje potrebne odmerke.
English: How does Axumin work?
Slovenian: Kako zdravilo Axumin deluje?
English: How is Axumin used?
Slovenian: Kako se zdravilo Axumin uporablja?
English: The PET images must be read by nuclear medicine physicians trained in interpreting PET scan images with Axumin.
Slovenian: Rezultate mora prebrati zdravstveni delavec, usposobljen za razlago slik, nastalih pri slikanju s PET.
English: The company that markets Axumin will ensure that all healthcare professional expected to use this product have access to education material to reduce errors in interpreting PET scan images.
Slovenian: Za zmanjšanje napak pri razlagi slik, slikanih s PET, bo družba, ki trži zdravilo Axumin, poskrbela, da bodo vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali to zdravilo, prejeli izobraževalno gradivo.
English: Depending on the person reading the scans, only 17 to 54% of patients whose tissue samples did not show cancer had a negative scan result.
Slovenian: Poleg tega je slikanje s PET v 92 % pravilno pokazalo, da se rak pri bolniku ni ponovno pojavil.
English: However, because some scans with Axumin were falsely positive (showing that cancer had returned when tissue sampling was negative), a positive result on its own is not enough to make a diagnosis.
Slovenian: Študije so dokazale, da je pri slikanju z zdravilom Axumin velika verjetnost pravilnega določanja mesta raka prostate, če se je rak vrnil.
English: Axumin can only be obtained with a prescription.
Slovenian: Predpisovanje in izdja zdravila Axumin je le na recept, slikanje s PET pa mora izvesti ustrezno usposobljeni zdravstveni delavec.
English: Pharmaceutical form Route of administration
Slovenian: Farmacevtska oblika Pot uporabe Stična ovojnina
English: 1 pre-filled syringe with needle safety guard
Slovenian: (steklena) z varnostno zaščito za iglo
English: Immediate Packaging
Slovenian: 6 napolnjenih
English: Pack size
Slovenian: HEXAL
English: • Patients with any question should speak to their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo z zdravnikom ali farmacevtom.
English: What are the recommendations for patients and prescribers?
Slovenian: Kakšna so priporočila za bolnike in zdravnike?
English: Questions and answers on the suspension of aprotinin
Slovenian: 1 Vprašanja in odgovori v zvezi z začasnim umikom aprotinina
English: Prescribers will be sent information on how to use the registry.
Slovenian: Zdravniki bodo prejeli informacije o tem, kako uporabljati register.
English: What are antifibrinolytics?
Slovenian: Kaj so antifibrinolitiki?
English: Why were antifibrinolytics reviewed?
Slovenian: Zakaj so bili antifibrinolitiki pregledani?
English: The European Commission issued a decision for aprotinin on 18 September 2013.
Slovenian: Evropska komisija je sklep o aprotininu izdala 18. septembra 2013.
English: There were also problems with the way data from some patients were excluded from the initial analyses and with the lack of appropriate monitoring of blood-thinning medicines the patients were taking.
Slovenian: Problematična sta bila tudi način izločanja podatkov o nekaterih bolnikih iz uvodne analize in pomanjkanje ustreznega spremljanja zdravil za redčenje krvi, ki so jih jemali bolniki.
English: Aprotinin had been approved in several EU countries for patients undergoing heart bypass surgery but was suspended in the EU by the European Commission in February 2008.
Slovenian: Aprotinin je bil odobren v več državah EU za bolnike, ki so prestali obvodno operacijo na srcu, vendar ga je Evropska komisija februarja 2008 začasno umaknila s trgov EU.
English: The Committee also looked at data from other clinical studies, the published literature, spontaneous reports of side effects and data submitted by companies that market antifibrinolytics.
Slovenian: Odbor je prav tako proučil podatke iz drugih kliničnih študij, objavljeno literaturo in spontana poročila o neželenih učinkih ter podatke, ki so jih predložile družbe, ki tržijo antifibrinolitike.
English: During the review, the CHMP took advice from a scientific advisory group, consisting of experts in cardiovascular and bleeding disorders.
Slovenian: Med pregledom se je CHMP posvetoval z znanstveno svetovalno skupino, v kateri so bili strokovnjaki za srčno-žilne bolezni in motnje strjevanja krvi.
English: • When aprotinin becomes available again, prescribers are advised to note the revised indication and to adhere closely to the updated prescribing advice.
Slovenian: • Ko bo aprotinin ponovno na voljo, naj zdravniki upoštevajo spremenjeno indikacijo in se strogo držijo posodobljenih navodil za predpisovanje zdravil.
English: Antifibrinolytics are medicines used to prevent excessive blood loss.
Slovenian: Antifibrinolitiki so zdravila, ki se uporabljajo za preprečevanje prevelike izgube krvi.
English: The CHMP was informed of ongoing pharmacokinetic studies which are to be finalised and assessed by national authorities.
Slovenian: CHMP so namreč obvestili, da že potekajo farmakokinetične študije, ki jih bodo zaključili in ocenili nacionalni organi.
English: • A registry will be set up in EU monitor the pattern of use of aprotinin.
Slovenian: • V EU bo vzpostavljen register za spremljanje načina uporabe aprotinina.
English: They have been used for several decades in patients undergoing certain dental or surgical operations as well as other patients at risk of complications from bleeding.
Slovenian: Že več desetletij se uporabljajo pri bolnikih, ki so prestali določene stomatološke ali kirurške posege, in drugih bolnikih, pri katerih obstaja tveganje za zaplete zaradi krvavitev.
English: The Committee has agreed with the companies marketing these medicines on a letter to be sent out to relevant healthcare professionals in the EU explaining the changes to the prescribing information.
Slovenian: Odbor se je z družbami, ki tržijo ta zdravila, dogovoril, da bodo zadevni zdravstveni delavci v EU prejeli dopis, v katerem bodo pojasnjene spremembe informacij o predpisovanju.
English: A registry will be set up in the EU to monitor the use of aprotinin, and the CHMP has approved a risk management plan for aprotinin medicines.
Slovenian: V EU bo vzpostavljen register, namenjen spremljanju uporabe aprotinina, CHMP pa je za zdravila, ki vsebujejo aprotinin, odobril tudi načrt obvladovanja tveganj.
English: As these medicines have been authorised since the 1960s, the CHMP reviewed the available evidence on their benefits in various conditions and made recommendations to harmonise the conditions for which these medicines should be used in the EU.
Slovenian: Ker so ta zdravila odobrena od 60. let prejšnjega stoletja, je CHMP pregledal razpoložljive dokaze o njihovi koristi pri različnih boleznih in priporočil uskladitev seznama bolezni, za katere se lahko ta zdravila uporabljajo v EU.
English: The way additional blood-thinning treatments (such as heparin) were used in the study was inconsistent and sometimes inappropriate, and this could have contributed to higher than expected rates of deaths in patients on aprotinin.
Slovenian: Način uporabe dodatnih zdravil za redčenje krvi (na primer heparina) v študiji je bil nedosleden in včasih tudi neprimeren, kar bi lahko prispevalo k temu, da je bila smrtnost pri bolnikih, ki so dobivali aprotinin, večja od pričakovane.
English: On 5 November 2007, the German medicines regulatory authority (BfArM) suspended the marketing authorisations for aprotinin-containing medicines in Germany.
Slovenian: Nemški regulativni organ za zdravila (BfArM) je 5. novembra 2007 v Nemčiji začasno umaknil dovoljenja za promet z zdravili, ki vsebujejo aprotinin.
English: The results from the BART study were not replicated in other studies, and when data from several studies (excluding BART) were analysed together, the results did not show that aprotinin is linked to a higher risk of death compared with other antifibrinolytics.
Slovenian: Rezultati iz študije BART se niso ponovili v drugih študijah, in ko so skupaj analizirali podatke iz različnih študij (z izjemo podatkov iz študije BART), rezultati niso pokazali, da bi bil aprotinin povezan z večjim tveganjem za smrt kot drugi antifibrinolitiki.
English: On 19 June 2012, following a re-examination, the CHMP confirmed its initial conclusions but decided to remove a requirement for a pharmacokinetic study with tranexamic acid.
Slovenian: Po ponovnem pregledu je CHMP 19. junija 2012 potrdil prvotne zaključke, vendar je sklenil, da bo umaknil zahtevo po izvedbi farmakokinetične študije s traneksamično kislino.
English: Aminocaproic acid and tranexamic acid are the commonly used antifibrinolytics in the EU.
Slovenian: Aminokaprojska kislina in traneksamična kislina sta antifibrinolitika, ki se pogosto uporabljata v EU.
English: Questions and answers on the review of antifibrinolytic medicines (aprotinin, aminocaproic acid and tranexamic acid)
Slovenian: Vprašanja in odgovori v zvezi s pregledom antifibrinolitikov (aprotinin, aminokaprojska kislina in traneksamična kislina)
English: The CHMP's review of aminocaproic acid and tranexamic acid, which are currently on the market in the EU, did not reveal any new safety concerns.
Slovenian: Med pregledom aminokaprojske kisline in traneksamične kisline, ki sta trenutno na trgu v EU, CHMP ni odkril nobenih novih zadržkov glede varnosti.
English: The CHMP reviewed data from the BART study, including additional data and analyses that became available since 2007.
Slovenian: CHMP je pregledal podatke iz študije BART, vključno z dodatnimi podatki in analizami, ki so postali na voljo po letu 2007.
English: The CHMP also recommended important changes to the prescribing information for aprotinin medicines, including restricting their use to isolated heart bypass surgery in adults at high risk of major blood loss and the inclusion of a warning on the risk of giving patients too little heparin (‘under heparinisation').
Slovenian: Prav tako je CHMP priporočil pomembne spremembe navodil za predpisovanje zdravil, ki vsebujejo aprotinin, vključno z omejitvijo uporabe na uporabo pri izoliranih obvodnih operacijah na srcu pri odraslih, ki so v veliki nevarnosti za obsežno izgubo krvi, in vključitvijo opozorila o tveganju, povezanim z dajanjem premajhnih količin heparina („nezadostna heparinizacija“).
English: On 12 March 2010, the German medicines agency asked the CHMP to carry out a full assessment of the benefits and risks of aprotinin, as well as those of aminocaproic acid and tranexamic acid, and to issue an opinion on their authorisation in the EU.
Slovenian: Nemška agencija za zdravila je 12. marca 2010 zaprosila CHMP, naj natančno oceni koristi in tveganja, povezana z aprotininom ter tudi z aminokaprojsko kislino in traneksamično kislino, ter izda mnenje glede odobritve teh učinkovin v EU.
English: • Prescribers should follow the new harmonised recommendations for the use of aminocaproic acid and tranexamic acid.
Slovenian: • Zdravniki naj upoštevajo nova usklajena priporočila glede uporabe aminokaprojske kisline in traneksamične kisline.
English: In patients at risk of significant bleeding, antifibrinolytics ensure that blood clots are not broken down too rapidly, which helps to reduce blood loss.
Slovenian: Pri bolnikih, ki so v nevarnosti za večjo krvavitev, antifibrinolitiki preprečijo prehitro razgradnjo krvnih strdkov in tako pomagajo zmanjšati izgubo krvi.
English: This decision was triggered by the early results of a study (the BART study) that showed a higher number of deaths 30 days after heart surgery among patients given aprotinin compared with patients given other antifibrinolytic treatments (aminocaproic acid and tranexamic acid).
Slovenian: Odločitev je bila posledica zgodnjih rezultatov študije (študije BART), ki so pokazali, da je bilo 30 dni po operaciji na srcu med bolniki, ki so jim dajali aprotinin, večje število smrtnih primerov kot med bolniki, ki so jim dajali druge antifibrinolitike (aminokaprojsko kislino in traneksamično kislino).