FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency in bleeding patients
Slovenian: Pogostnost pri bolnikih s krvavitvijo
English: Of 352 enrolled patients, 249 (70.7%) were included in the efficacy-analysis.
Slovenian: Od 352 vključenih bolnikov so v analizo učinkovitosti vključili 249 bolnikov (70,7 %).
English: All PK studies were conducted using a former drug substance generation.
Slovenian: Vse študije FK so bile izvedene s prejšnjo generacijo učinkovine zdravila.
English: • flushing or feeling hot
Slovenian: • pordevanje ali občutek vročine,
English: Chemical and physical in-use stability have been demonstrated for 16 hours at 2°C to 8°C in the primary packaging vial.
Slovenian: Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 16 ur pri temperaturi od 2 °C do 8 °C v viali primarne ovojnine.
English: This leaflet was last revised in Month YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano meseca LLLL.
English: The adverse reactions are classified by system organ class (SOC) and frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); or not known (cannot be estimated from available data).
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Aseptic technique during the reconstitution procedure should be used.
Slovenian: Med postopkom rekonstitucije je treba uporabljati aseptično tehniko.
English: Gently swirl each vial until all of the powder is completely dissolved.
Slovenian: Nežno vrtite vsako vialo, dokler se ves prašek popolnoma ne raztopi.
English: These antibodies were generally low titre, and no clinical consequences were observed.
Slovenian: Ta protitelesa so bila na splošno prisotna v majhnih titrih, kliničnih posledic pa niso opazili.
English: EU/1/18/1345/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/18/1345/001
English: Initial intravenous bolus
Slovenian: Začetni intravenski bolus
English: Antithrombotic therapy can be re-initiated as soon as medically indicated following treatment if the patient is clinically stable and adequate haemostasis has been achieved.
Slovenian: Antitrombotično zdravljenje je mogoče po zdravljenju s tem zdravilom ponovno uvesti, takoj ko je medicinsko indicirano, če je bolnik klinično stabilen in je bila dosežena zadostna hemostaza.
English: Distribution The Vd for andexanet alfa is 5.3 ± 2.6 L, approximately equivalent to the blood volume.
Slovenian: Vd andeksaneta alfa je 5,3 ± 2,6 l, kar približno ustreza volumnu krvi.
English: Restoration of thrombin generation
Slovenian: Obnova tvorbe trombina
English: Name and address of the manufacturer of the biological active substance Lonza Biologics Porrino, S.L.
Slovenian: Ime in naslov izdelovalca biološke učinkovine Lonza Biologics Porrino, S.L.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se ne uporabi takoj, je za čas shranjevanja med uporabo in pogoje pred uporabo odgovoren uporabnik.
English: Although determination of anti-FXa-activity in emergency situations is increasingly recommended, no recommendation for adapted andexanet alfa dosage is available.
Slovenian: Čeprav se vedno bolj priporoča ugotavljanje aktivnosti proti FXa v nujnih situacijah, priporočila za prilagojeno odmerjanje andeksaneta alfa niso na voljo.
English: Limitations of use
Slovenian: Omejitve uporabe
English: In case of mild or moderate infusion reactions, careful observation may be sufficient.
Slovenian: Reakcije, povezane z infuzijo V primeru blagih ali zmernih reakcij, povezanih z infuzijo, lahko zadošča natančno opazovanje.
English: • Alcohol swabs.
Slovenian: • Alkoholne robčke.
English: Paediatric population: The safety and efficacy of andexanet alfa in children and adolescents have not been established.
Slovenian: Pediatrična populacija: Varnost in učinkovitost andeksaneta alfa pri otrocih in mladostnikih nista bili dokazani.
English: For reconstituted solutions, chemical and physical in-use stability have been demonstrated for at least eight hours at 25°C.
Slovenian: Za rekonstituirane raztopine so kemično in fizikalno stabilnost med uporabo dokazali za najmanj osem ur pri temperaturi 25 °C.
English: • The active substance is andexanet alfa.
Slovenian: • Učinkovina je andeksanet alfa.
English: The interaction between andexanet alfa and TFPI has not been fully characterized.
Slovenian: Interakcija med andeksanetom alfa in TFPI še ni v celoti karakterizirana.
English: Data from bleeding patients are limited.
Slovenian: Podatki o krvavečih bolnikih so omejeni.
English: Use of andexanet alfa in conjunction with other supportive measures Andexanet alfa can be used in conjunction with standard haemostatic supportive measures, which should be considered as medically appropriate.
Slovenian: Uporaba andeksaneta alfa v povezavi z drugimi podpornimi ukrepi Andeksanet alfa se lahko uporablja v povezavi s standardnimi hemostatskimi podpornimi ukrepi, o katerih je treba razmisliti, kot je medicinsko primerno.
English: PK comparability with andexanet alfa in Ondexxya (Generation 2) has not yet been proven.
Slovenian: Primerljivost FK z andeksanetom alfa v zdravilu Ondexxya (2. generacija) še ni bila dokazana.
English: Hypersensitivity to the active substance or to any other ingredients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Continuous intravenous infusion
Slovenian: Kontinuirana intravenska infuzija
English: Powder in a 20 mL vial (Type I glass) with a stopper (butyl rubber).
Slovenian: Prašek v 20-ml viali (steklo tipa I) z zamaškom (butilna guma).
English: * Andexanet alfa is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
Slovenian: * Andeksanet alfa se izdeluje s tehnologijo rekombinantne DNA v ovarijskih celicah kitajskega hrčka
English: Among the healthy subjects studied, women experienced more adverse reactions (mainly infusion-related reactions) than men.
Slovenian: Med zdravimi osebami se je pri ženskah pojavilo več neželenih učinkov (večinoma reakcij, povezanih z infuzijo) kot pri moških.
English: Therefore, treatment monitoring should be based mainly on clinical parameters indicative of appropriate response (i.e., achievement of haemostasis), lack of efficacy (i.e., re-bleeding), and adverse events (i.e., thromboembolic events).
Slovenian: Zato mora spremljanje med zdravljenjem v glavnem temeljiti na kliničnih parametrih, ki kažejo na ustreznost odziva (npr. doseganje hemostaze), pomanjkanje učinkovitosti (npr. ponovna krvavitev) in neželene dogodke (npr. trombembolične dogodke).
English: Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, to povejte zdravniku.
English: Known allergic reaction to hamster proteins.
Slovenian: Znana alergijska reakcija na beljakovine hrčka.
English: To date, the occurrence of positive, non-neutralizing antibodies to andexanet alfa following treatment in patients in the ANNEXA-4 study (8.5% or 20/236 patients) has been similar to that observed in healthy subjects.
Slovenian: Do zdaj je bilo pojavljanje pozitivnih, ne-nevtralizirajočih protiteles proti andeksanetu alfa po zdravljenju pri bolnikih v študiji ANNEXA-4 (8,5 % bolnikov oziroma 20/236 bolnikov) podobno tistemu, ki so ga opazili pri zdravih osebah.
English: These markers were not measured in patients enrolled in the ANNEXA-4 study, but thromboembolic events have been observed (see section 5.1).
Slovenian: Teh označevalcev pri bolnikih, vključenih v študijo ANNEXA-4, niso merili, so pa opazili trombembolične dogodke (glejte poglavje 5.1).
English: Reduction in anti-FXa activity
Slovenian: Zmanjšanje aktivnosti proti FXa
English: Transient elevations of D-dimer and F1+2 fragments very common
Slovenian: Prehodno zvišanje vrednosti D-dimera in fragmentov F1 + 2
English: Your doctor may give you an antihistamine medicine to help with any side effects (see section 4).
Slovenian: Zdravnik vam bo morda dal antihistaminike za pomoč pri morebitnih neželenih učinkih (glejte poglavje 4).
English: A total of 33.3% of patients with thromboembolic events (12/36) experienced the thromboembolic event during the first three days.
Slovenian: Skupno 33,3 % bolnikov s trombemboličnim dogodkom (12/36 bolnikov) je imelo trombembolični dogodek v prvih treh dneh.
English: Anti-FXa activity correlates poorly to clinical efficacy and safety, making it unsuitable for dosing guidance (see section 4.4 and 5.1)
Slovenian: Aktivnost proti FXa šibko korelira s klinično učinkovitostjo in varnostjo, zaradi česar ni primerna smernica za odmerjanje (glejte poglavji 4.4 in 5.1).
English: The posology was confirmed in a study in patients with acute major bleeding.
Slovenian: Odmerjanje so potrdili v študiji pri bolnikih z večjo akutno krvavitvijo.
English: Use for edoxabanor enoxaparin-reversal is not recommended due to lack of data.
Slovenian: Uporaba za odpravo učinka edoksabana ali enoksaparina se zaradi pomanjkanja podatkov ne priporoča.
English: Andexanet alfa does not need to be brought to room temperature before reconstitution or administration to the patient.
Slovenian: Andeksaneta alfa ni treba ogreti na sobno temperaturo pred rekonstitucijo oziroma dajanjem bolniku.
English: It is unlikely that Ondexxya will influence the effect of other medicines or that other medicines will influence Ondexxya.
Slovenian: Ni verjetno, da bi zdravilo Ondexxya vplivalo na učinek drugih zdravil ali da bi druga zdravila vplivala na zdravilo
English: Store in a refrigerator.
Slovenian: DRUGI PODATKI Shranjujte v hladilniku.
English: Clinical relevance in the target population (patients with uncontrolled or life-threatening bleeding who are anticoagulated due to high to very high risk of thrombosis) is unknown.
Slovenian: Klinični pomen za ciljno populacijo (bolnike z neobvladano ali smrtno nevarno krvavitvijo, ki prejemajo antikoagulantno terapijo zaradi velikega do zelo velikega tveganja za trombozo) ni znan.
English: In ANNEXA-4, intracranial haemorrhage (ICH) patients (GCS > 7 and haematoma volume < 60 mL) have been included.
Slovenian: V študijo ANNEXA-4 so bili vključeni bolniki z intrakranialno krvavitvijo (GCS > 7 in volumen hematoma < 60 ml).
English: The safety of andexanet alfa has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood within seven days prior to the bleeding event, as they were excluded from clinical trials.
Slovenian: Varnost andeksaneta alfa ni bila ocenjena pri bolnikih, ki so prejeli koncentrate protrombinskega kompleksa, rekombinantni faktor VIIa ali polno kri v času sedmih dni pred krvavitvijo, saj so bili izključeni iz kliničnih preskušanj.
English: Reduction in anti-FXa activity correlates with restoration of thrombin generation.
Slovenian: Zmanjšanje aktivnosti proti FXa korelira z obnovo tvorbe trombina.
English: The anti-FXa activity returned to the placebo levels and above approximately two hours after the end of a bolus or infusion dependent on dosage.
Slovenian: Aktivnost proti FXa se je vrnila na raven placeba in višje približno dve uri po koncu dajanja bolusa ali infundiranja, odvisno od odmerka.
English: The most common side effects associated with Ondexxya in clinical trials of healthy people were infusion-related reactions with usually mild symptoms such as flushing or feeling hot (very common side effects which may affect more than 1 in 10 people).
Slovenian: Najpogostejši neželeni učinki, ki so bili povezani z zdravilom Ondexxya v kliničnih preskušanjih pri zdravih ljudeh, so bile z infuzijo povezane reakcije, ki so ponavadi imele blage simptome, kot so pordevanje ali občutek vročine (zelo pogosta neželena učinka, ki se lahko pojavita pri več kot 1 bolniku od 10 bolnikov).
English: Reversing the effect of a factor Xa inhibitor with Ondexxya may increase the risk of blood clots.
Slovenian: Odprava učinkov zaviralca faktorja Xa z zdravilom Ondexxya lahko poveča tveganje za krvne strdke.
English: The reconstituted solution is a clear, colourless, or slightly yellow solution.
Slovenian: Rekonstituirana tekočina je bistra, brezbarvna ali bledo rumena raztopina.
English: All used syringes, needles, and vials, including any unused portion of reconstituted solution, should be disposed of in accordance with local requirements.
Slovenian: Vse uporabljene injekcijske brizge, igle in viale, vključno z vso neuporabljeno rekonstituirano raztopino, zavrzite v skladu z lokalnimi predpisi.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: 6.2 Inkompatibilnosti Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: 8 mg/min for 120 minutes (960 mg)
Slovenian: 8 mg/min v trajanju 120 minut (960 mg)
English: In addition, independent pro-thrombotic effect of andexanet alfa cannot be ruled out.
Slovenian: Poleg tega ni mogoče izključiti neodvisnega protrombotičnega učinka andeksaneta alfa.
English: 297/352 patients (84.4%) received the low-dose regimen of andexanet, while 55 patients (15.6%) received the high-dose regimen.
Slovenian: 297/352 bolnikov (84,4 %) je prejelo shemo z majhnim odmerkom andeksaneta, 55 bolnikov (15,6 %) pa je prejelo shemo z velikim odmerkom andeksaneta.
English: Restarting antithrombotic therapy
Slovenian: Ponoven začetek antitrombotičnega zdravljenja
English: Biliary and/or faeces elimination of protein therapeutics is not a known route of protein elimination.
Slovenian: Izločanje beljakovinskih zdravil v žolč in/ali blato ni znana pot izločanja beljakovin.
English: Andexanet alfa is a recombinant form of human FXa protein that has been modified to lack FXa enzymatic activity.
Slovenian: Andeksanet alfa je rekombinantna oblika humane beljakovine FXa, ki je bila spremenjena tako, da nima encimske aktivnosti FXa.
English: 4 mg/min for 120 minutes (480 mg)
Slovenian: 4 mg/min v trajanju 120 minut (480 mg)
English: For the most efficient reconstitution of the needed dose, and to minimise errors, inject each vial needed with 20 mL of water for injections before proceeding to the next step.
Slovenian: Da bo rekonstitucija potrebnega odmerka najučinkovitejša, možnost napak pa najmanjša, v vsako potrebno vialo vbrizgajte 20 ml vode za injekcije, preden nadaljujete z naslednjim korakom.
English: In the ANNEXA-4 study, of the patients in the safety population completing 30-day follow up (N=351), 54 patients (15.4%) died.
Slovenian: V študiji ANNEXA-4 je od bolnikov v populaciji za oceno varnosti, ki so dokončali 30-dnevno spremljanje (N = 351), umrlo 54 bolnikov (15,4 %).
English: Treatment-emergent, non-neutralizing antibodies to andexanet alfa were detected in approximately 10% (35/345).
Slovenian: Nenevtralizirajoča protitelesa proti andeksanetu alfa, ki so se pojavila v povezavi z zdravljenjem, so zaznali pri približno 10 % bolnikov (35/345).
English: The antiFXa activity thresholds for normalization of thrombin generation (defined by mean ETP and standard deviations) were estimated to be 44.2 ng/mL (within one standard deviation of normal ETP) based on pooled data from Studies 14-503 and 14-504, as indicated in the figure.
Slovenian: FXa za normalizacijo tvorbe trombina (opredeljene s povprečnim ETP in standardnimi odkloni) so bile ocenjene na 44,2 ng/ml (znotraj enega standardnega odklona od normalnega ETP) na podlagi združenih podatkov iz študij 14-503 in 14-504, kar je prikazano na sliki.
English: • if you are allergic to hamster proteins
Slovenian: • če ste alergični na beljakovine hrčka.
English: Plasma TFPI activity has been shown to be inhibited for 10 to 20 hours following andexanet alfa administration.
Slovenian: Za aktivnost plazemskega TFPI so dokazali, da je bila zavrta 10 ur do 20 ur po dajanju andeksaneta alfa.
English: Total number of 200 mg vials needed
Slovenian: Skupno število potrebnih 200-mg vial
English: • stomach pain or discomfort
Slovenian: • bolečina ali neugodje v želodcu,
English: Thrombotic events have been reported following treatment with andexanet alfa (see sections 4.8 and 5.1).
Slovenian: Po zdravljenju z andeksanetom alfa so poročali o trombotičnih dogodkih (glejte poglavji 4.8 in 5.1).
English: In order to further confirm the efficacy and safety, the MAH should submit an updated PK/PD model using all previously incorporated data (from studies 11-501, 12-502, 14503, 14-504, and 14-506) as well as newly incorporated data from study 16-512 (PKPD study of Generation 2 andexanet versus Generation 1), study 16-508 (PK-PD study of andexanet in individuals of Japanese ethnicity), and study 14-505 (ANNEXA-4).
Slovenian: Za nadaljnjo potrditev učinkovitosti in varnosti mora imetnik dovoljenja za promet predložiti posodobljen model FK/FD, v katerem bodo uporabljeni vsi predhodno vključeni podatki (iz študij 11-501, 12-502, 14-503, 14-504 in 14-506) ter novo vključeni podatki iz študije 16-512 (študija FK-FD andeksaneta 2. generacije v primerjavi s 1. generacijo), študije 16-508 (študija FK-FD andeksaneta pri osebah japonske narodnosti) in študije 14-505 (ANNEXA-4).
English: This medicine is for hospital use only.
Slovenian: To zdravilo je namenjeno samo za uporabo v bolnišnici.
English: Studies to evaluate the mutagenic and carcinogenic potential of andexanet alfa have not been performed.
Slovenian: Študij za oceno mutagenega in karcinogenega potenciala andeksaneta alfa niso izvedli.
English: > 10 mg/ Unknown
Slovenian: > 10 mg/neznano
English: This medicine is unlikely to affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi to zdravilo vplivalo na vašo sposobnost vožnje in upravljanja strojev.
English: When andexanet alfa was administered as a bolus followed by a continuous infusion, the maximum decrease in unbound FXa inhibitors was rapid (within two minutes of the end of the bolus) and was sustained over the course of the infusion then gradually increased over time, reaching a maximum at approximately two hours following the end of infusion.
Slovenian: Ko so andeksanet alfa dali v obliki bolusa, ki mu je sledila kontinuirana infuzija, je bilo največje zmanjšanje nevezanih zaviralcev FXa zelo hitro doseženo (v dveh minutah po koncu bolusa) in se je ohranilo v celotnem času infuzije, nato pa sčasoma postopno zvišalo, pri čemer je bila največja vrednost dosežena približno dve uri po koncu infundiranja.
English: Of the 209 patients who were re-anticoagulated prior to a thrombotic event, 10 (4.8%) patients experienced a thromboembolic event.
Slovenian: Od 209 bolnikov, ki so pred trombotičnim dogodkom prejemali antikoagulacijsko zdravljenje, je 10 bolnikov (4,8 %) imelo trombembolični dogodek.
English: Reversal of the effects of other FXa inhibitors (e.g., fondaparinux, unfractionated heparin) with andexanet alfa has not been studied in humans.
Slovenian: Odprave učinkov drugih zaviralcev FXa (npr. fondaparinuksa, nefrakcioniranega heparina) z andeksanetom alfa pri ljudeh niso proučili.
English: Change in anti-FXa activity (ng/mL) in healthy subjects anticoagulated with apixaban (A) and rivaroxaban (B)
Slovenian: Sprememba aktivnosti proti FXa (ng/ml) pri zdravih osebah, ki so prejemale antikoagulacijsko zdravljenje z apiksabanom (A) in rivaroksabanom (B)
English: Clearance (L/hr) for andexanet alfa is 4.4 ± 1.2 L/hr with low renal elimination.
Slovenian: Očistek (l/uro) andeksaneta alfa je 4,4 ± 1,2 l/uro, z majhnim ledvičnim izločanjem.
English: The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin, and the gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the ability of the protein to assemble into the prothrombinase complex, thus removing any anti-coagulant effects.
Slovenian: Serin aktivnega mesta je bil zamenjan z alaninom, zaradi česar molekula ne more cepiti in aktivirati protrombina, domena gama-karboksiglutaminske kisline (Gla) pa je bila odstranjena, da se odstrani sposobnost beljakovine za sestavljanje v kompleks protrombinaze in s tem tudi vsako antikoagulacijsko delovanje.
English: The most frequently observed adverse reactions were mild or moderate infusion-related reactions (see table 4) comprising symptoms such as flushing, feeling hot, cough, dysgeusia, and dyspnoea occurring within a few minutes to a few hours of the infusion.
Slovenian: Najpogosteje opaženi neželeni učinki so bile blage ali zmerne reakcije, povezane z infuzijo (glejte preglednico 4), ki so zajemale simptome, kot so pordevanje, občutek vročine, kašelj, disgevzija in dispneja, ki so se pojavili od nekaj minut do nekaj ur po infundiranju.
English: For these patients, median anti-FXa activity at baseline was 149.7 ng/mL for patients taking apixaban, and 211.8 ng/mL for patients taking rivaroxaban.
Slovenian: Pri teh bolnikih je bila mediana aktivnost proti FXa ob izhodišču149,7 ng/ml pri bolnikih, ki so prejemali apiksaban, in 211,8 ng/ml pri bolnikih, ki so prejemali rivaroksaban.
English: Pro-coagulant factor treatments (e.g., 3- or 4-factor prothrombin complex concentrate (PCC)/activated PCC, recombinant factor VIIa, fresh frozen plasma) and whole blood should be avoided unless absolutely required, due to lack of data in combination with these treatments.
Slovenian: Zdravljenju s prokoagulacijskimi faktorji (npr. s koncentratom protrombinskega kompleksa s 3 ali 4 faktorji (PCC)/aktiviranim PCC, rekombinantnim faktorjem VIIa, sveže zmrznjeno plazmo) in polno krvjo se je treba zaradi pomanjkanja podatkov o tovrstnih kombinacijah izogniti, če ni nujno potrebno.
English: The safety and efficacy have not been studied in patients with hepatic impairment (see section 5.2).
Slovenian: Varnosti in učinkovitosti pri bolnikih z okvaro jeter niso proučili (glejte poglavje 5.2).
English: Renal impairment: The effect of renal impairment on andexanet alfa exposure levels has not been evaluated.
Slovenian: Okvara ledvic: Učinka okvare ledvic na ravni izpostavljenosti andeksanetu alfa niso ocenili.
English: No neutralising antibodies or antibodies to factor X or FXa were detected.
Slovenian: Nevtralizirajočih protiteles ali protiteles proti faktorju X ali FXa niso zaznali.
English: According to region, death rates were 22.1% (31/140) in patients recruited in the European Union and 10.9% (23/211) in patients recruited in North America.
Slovenian: Glede na regijo je bila stopnja smrtnosti za bolnike, vključene v Evropski uniji, 22,1 % (31/140) ter 10,9 % (23/211) za bolnike, vključene v Severni Ameriki.
English: Wipe the rubber stopper of each vial with an alcohol swab.
Slovenian: Gumijasti zamašek vsake viale obrišite z alkoholnim robčkom.
English: Factor Xa inhibitors are given to prevent clots in your blood vessels.
Slovenian: Zaviralci faktorja Xa se uporabljajo za preprečevanje strdkov v vaših krvnih žilah.
English: Thirty-six of 352 patients with complete 30-day safety follow up (10.3%) had thrombotic events, including venous thromboembolism (VTE), myocardial infarction (MI), and stroke.
Slovenian: Šestintrideset bolnikov od 352 bolnikov z zaključenim 30-dnevnim spremljanjem varnosti (10,3 %) je imelo trombotične dogodke, vključno z vensko trombembolijo (VTE), miokardnim infarktom (MI) in možgansko kapjo.
English: Ten of 36 (27.8%) patients had restarted antithrombotic therapy at the time of the event, and all 36 patients had been anticoagulated for a prior history of VTE and/or atrial fibrillation at the time of receiving andexanet alfa (see sections 4.4 and 5.1).
Slovenian: Deset bolnikov od 36 bolnikov (27,8 %) je v času dogodka že ponovno začelo prejemati antitrombotično zdravljenje, vseh 36 bolnikov pa je v času, ko so prejeli zdravljenje z andeksanetom alfa, že prejemalo antikoagulantno terapijo zaradi anamneze venske trombembolije in/ali atrijske fibrilacije (glejte poglavji 4.4 in 5.1).