FrancophonIA/ELRC3.0 huggingface dataset:
English: Fertility There are no data on the effects of andexanet alfa on human fertility.
Slovenian: Podatkov o vplivu andeksaneta alfa na plodnost pri človeku ni.
English: While it is permissible to combine the bolus and infusion into a single IV bag, it is recommended that the bolus and infusion be split into two separate bags to ensure the correct administration rate.
Slovenian: Čeprav je dovoljeno bolus in infuzijo združiti v isti vrečki za infuzijo, se priporoča, da bolus in infuzijo ločite na dve vrečki, da zagotovite pravilno hitrost infundiranja.
English: After you have received Ondexxya, your doctor will decide when to restart your anticoagulant treatment.
Slovenian: Po tem, ko ste prejeli zdravilo Ondexxya, bo zdravnik odločil, kdaj ponovno začeti antikoagulacijsko zdravljenje.
English: Other medicines and Ondexxya
Slovenian: Druga zdravila in zdravilo Ondexxya
English: It will not reverse the effects of non-FXa inhibitors.
Slovenian: Ne odpravi učinkov zaviralcev, ki ne zavirajo FXa.
English: Vial (unopened) Two years stored at 2°C to 8°C.
Slovenian: Dve leti pri shranjevanju pri temperaturi od 2 °C do 8 °C.
English: Breast-feeding should be discontinued during treatment with andexanet alfa.
Slovenian: Med zdravljenjem z andeksanetom alfa je treba prenehati z dojenjem.
English: Dosage recommendations have been defined from the effects of andexanet alfa in healthy volunteers administered a direct FXa inhibitor and from the ability to reverse the levels of anti-FXa activity.
Slovenian: Priporočila za odmerjanje so bila oblikovana na podlagi učinkov andeksaneta alfa pri zdravih prostovoljcih, ki so prejeli neposredni zaviralec FXa, in zmožnosti odprave aktivnosti proti FXa.
English: mannitol, and polysorbate 80.
Slovenian: manitol, polisorbat 80
English: Administration of andexanet alfa as a bolus followed by continuous infusion resulted in a sustained decrease in anti-FXa activity.
Slovenian: Dajanje andeksaneta alfa v obliki bolusa, ki mu sledi kontinuirana infuzija, je povzročilo stabilno zmanjšanje aktivnosti proti FXa.
English: From a microbiological point of view, once reconstituted, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika velja, da je treba rekonstituirano zdravilo uporabiti takoj.
English: The safety has been evaluated in clinical trials including 247 healthy subjects administered an FXa inhibitor, as well as in 352 patients in a Phase IIIb/IV trial (ANNEXA-4), who had acute major bleeding and were under treatment with an FXa inhibitor (mostly apixaban and rivaroxaban).
Slovenian: Varnost so ocenili v kliničnih preskušanjih, v katera je bilo vključenih 247 zdravih prostovoljcev, ki so prejeli zaviralec FXa, ter pri 352 bolnikih, vključenih v preskušanje faze IIIb/IV (ANNEXA-4), ki so imeli večjo akutno krvavitev in so se zdravili z zaviralcem FXa (večinoma apiksabanom in rivaroksabanom).
English: Thrombotic events
Slovenian: Trombotični dogodki
English: Administration using an intravenous bag 1.
Slovenian: Dajanje z uporabo vrečke za infuzijo 1.
English: • feeling cold
Slovenian: • občutek hladu,
English: • The other ingredients are Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose,
Slovenian: • Druge sestavine so tris (hidroksimetil) aminometan, tris hidroklorid, L‑argininijev klorid,
English: • Large (60 mL or larger) sterile syringe.
Slovenian: • Veliko sterilno injekcijsko brizgo (60 ml ali večjo).
English: Due to the additional volume, the high dose bolus and infusion have to be further separated into additional syringes (two syringes apiece for bolus and infusion).
Slovenian: Zaradi dodatnega volumna je treba raztopino za bolus in za infundiranje z velikim odmerkom nadalje razdeliti v dodatne injekcijske brizge (po dve injekcijski brizgi za bolus in za infundiranje).
English: Each vial contains 200 mg of andexanet alfa*.
Slovenian: Ena viala vsebuje 200 mg andeksaneta alfa*.
English: Discard all used syringes, needles, and vials, including any unused portion of reconstituted solution.
Slovenian: Zavrzite vse uporabljene injekcijske brizge, igle in viale, vključno z vso neuporabljeno rekonstituirano raztopino.
English: The second column provides the list of adverse reactions from the interim results of the Phase IIIb/IV ANNEXA-4 study, including 352 patients with acute major bleeding treated with andexanet alfa.
Slovenian: V drugem stolpcu je seznam neželenih učinkov na podlagi vmesnih rezultatov študije faze IIIb/IV ANNEXA-4, v katero je vključenih 352 bolnikov z večjo akutno krvavitvijo, zdravljenih z andeksanetom alfa.
English: Change from baseline in free FXa inhibitor concentration at nadir The mean unbound concentrations of apixaban and rivaroxaban were < 3.5 ng/mL and 4 ng/mL, respectively, after bolus andexanet alfa administration and were maintained throughout the continuous infusion.
Slovenian: Sprememba koncentracije prostih zaviralcev FXa v nadirju glede na izhodišče Po dajanju bolusa andeksaneta alfa je bila povprečna koncentracija nevezanega apiksabana in rivaroksabana < 3,5 ng/ml oziroma 4 ng/ml, ki se je ohranila med celotno kontinuirano infuzijo.
English: Paediatric population The pharmacokinetics of andexanet alfa has not been studied in paediatric patients.
Slovenian: Pediatrična populacija Farmakokinetike andeksaneta alfa pri pediatričnih bolnikih niso proučili.
English: After treatment with Ondexxya, your doctor will decide when to restart anticoagulant therapy.
Slovenian: Po zdravljenju z zdravilom Ondexxya bo zdravnik odločil, kdaj ponovno začeti antikoagulacijsko zdravljenje.
English: In the healthy subject trials, elevations > 2 x ULN in D-dimer and prothrombin fragments F1+2 were frequently observed.
Slovenian: V preskušanjih z zdravimi osebami so pogosto opazili več kot dvakratno zvišanje nad zgornjo mejo normalne vrednosti D-dimera in protrombinskih fragmentov F1 + 2.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity studies up to two weeks in rats and monkeys.
Slovenian: Predklinični podatki na podlagi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih na podganah in opicah, ki so trajale do dva tedna, ne kažejo posebnega tveganja za človeka
English: Transfer the reconstituted solution from the syringe into an appropriate IV bag.
Slovenian: Rekonstituirano raztopino prenesite iz injekcijske brizge v primerno vrečko za infuzijo.
English: Prepare the bolus and infusion in separate large volume syringes.
Slovenian: Raztopino za bolus in za infuzijo pripravite v ločenih velikih injekcijskih brizgah.
English: The efficacy and safety of andexanet alfa have been evaluated in the following: 1) randomized, placebo-controlled, Phase II dose-ranging trials with healthy volunteers administered FXa inhibitors to establish doses required for reversal; 2) two Phase III studies, one with apixaban and the other with rivaroxaban, to confirm the efficacy of the high and low dose regimens; and 3) a global, multicentre, prospectively defined, open-label Phase IIIb/IV study (ANNEXA-4) in patients with an acute major bleeding episode requiring urgent reversal of FXa anticoagulation.
Slovenian: faze pri zdravih prostovoljcih, ki so prejeli zaviralce FXa za ugotovitev odmerkov, potrebnih za odpravo; 2) dveh študijah III. faze, eni z apiksabanom in drugi z rivaroksabanom, za potrditev učinkovitosti shem z velikimi in majhnimi odmerki; in 3) globalni multicentrični, prospektivno opredeljeni odprti študiji faze IIIb/IV (ANNEXA-4) pri bolnikih z epizodo večje akutne krvavitve, ki so potrebovali nujno odpravo antikoagulacije FXa.
English: No interaction studies with andexanet alfa have been performed.
Slovenian: Študij medsebojnega delovanja z andeksanetom alfa niso izvedli.
English: Animal reproductive and developmental studies have not been conducted with andexanet alfa.
Slovenian: Študij razmnoževanja in razvoja z andeksanetom alfa na živalih niso izvedli.
English: Reconstituted medicinal product
Slovenian: Rekonstituirano zdravilo
English: The bolus and infusion are prepared in separate large volume syringes.
Slovenian: Raztopina za bolus in za infuzijo se pripravi v ločenih velikih injekcijskih brizgah.
English: In healthy volunteers, dose-dependent increases in coagulation markers F1+2, TAT, and D-dimer after administration of andexanet alfa were observed, but no thromboembolic events were reported.
Slovenian: Pri zdravih prostovoljcih so po dajanju andeksaneta alfa opazili od odmerka odvisna zvišanja ravni označevalcev koagulacije F1 + 2, TAT in D-dimera, vendar niso poročali o trombemboličnih dogodkih.
English: The reconstituted solution should be inspected for particulate matter and/or discolouration prior to administration.
Slovenian: Rekonstituirano zdravilo je treba pred dajanjem vizualno pregledati glede prisotnosti delcev in/ali obarvanja.
English: Based on what is known about the disposition kinetics of native FXa, andexanet alfa is likely rapidly broken down in plasma by endogenous proteases, consistent with its relatively short effective half-life (one hour).
Slovenian: endogene proteaze verjetno hitro razgradijo andeksanet alfa v plazmi, kar se sklada z njegovim razmeroma kratkim efektivnim razpolovnim časom (ena ura).
English: In prospective, randomized, placebo-controlled, dose-ranging studies in healthy subjects, the dose and dose regimen of andexanet alfa required to reverse anti-FXa activity and restore thrombin generation for FXa inhibitors (apixaban or rivaroxaban) were determined.
Slovenian: V prospektivni, randomizirani, s placebom nadzorovani študiji razpona odmerkov pri zdravih prostovoljcih so določili odmerek in shemo odmerjanja andeksaneta alfa, potrebna za odpravo aktivnosti proti FXa in obnovo tvorbe trombina pri zaviralcih FXa (apiksaban ali rivaroksaban).
English: Reversal of FXa inhibitor anticoagulation in patients with acute major bleeding In Study 14-505 (ANNEXA-4), a Phase IIIb/IV multinational, prospective, single-arm, open-label study, Ondexxya was administered to 352 patients on FXa inhibitors who presented with acute major bleeding.
Slovenian: Odprava antikoagulacije zaradi zaviralca FXa pri bolnikih z večjo akutno krvavitvijo V večnacionalni, prospektivni odprti študiji 14-505 (ANNEXA-4) z enim krakom faze IIIb/IV so zdravilo Ondexxya dali 352 bolnikom, zdravljenim z zaviralci FXa, ki so imeli večjo akutno krvavitev.
English: Andexanet alfa is a specific reversal agent for FXa inhibitors.
Slovenian: Andeksanet alfa je specifično zdravilo za odpravo učinka zaviralcev FXa.
English: Table 1: Dosing regimens
Slovenian: Preglednica 1: Sheme odmerjanja
English: Very common (may affect more than 1 in 10 people)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 bolniku od 10 bolnikov):
English: Administration using an intravenous bag
Slovenian: Dajanje z uporabo vrečke za infuzijo
English: Cardiovascular causes of death (n=27) included: haemorrhagic stroke (n=6), ischaemic stroke (n=5), sudden cardiac death (including unwitnessed) (n=5), cardiomechanical/pump failure (n=4), myocardial infarction (n=2), bleeding other than haemorrhagic stroke (n=1), and other cardiovascular causes (n=4).
Slovenian: Srčno-žilni vzroki smrti (n = 27) so zajemali: hemoragično možgansko kap (n = 6), ishemično možgansko kap (n = 5), nenadno srčno smrt (vključno s smrtjo brez prič) (n = 5), kardiomehansko odpoved/odpoved črpalke (n = 4), miokardni infarkt (n = 2), krvavitev, ki ni bila hemoragična možganska kap (n = 1), in druge srčno-žilne vzroke (n = 4).
English: Treatment of patients with more severe ICH with andexanet alfa has not been studied.
Slovenian: Zdravljenja bolnikov s hujšo intrakranialno krvavitvijo z andeksanetom alfa niso proučevali.
English: In order to further substantiate correlation of the biomarker (antiFXa-activity) with haemostatic efficacy and clarify the risk of thromboses and thromboembolic events, the MAH should submit the results of ANNEXA-4, an interventional non-randomized, multicentre, prospective, open-label, single-group study in patients with acute major bleeding.
Slovenian: Za nadaljnjo utemeljitev korelacije med biološkim označevalcem (delovanjem proti FXa) in hemostatsko učinkovitostjo ter razjasnitev tveganja za tromboze in trombembolične dogodke mora imetnik dovoljenja za promet z zdravilom predložiti rezultate intervencijske nerandomizirane multicentrične prospektivne odprte študije z eno skupino ANNEXA-4 pri bolnikih z večjo akutno krvavitvijo.
English: In a study comparing andexanet alfa pharmacokinetics in elderly (65-69 years) and younger (26-42 years) healthy subjects who had received apixaban, the pharmacokinetics of andexanet alfa in the elderly subjects were not statistically different than those in the younger subjects.
Slovenian: (26-42 let) zdravih osebah, ki so prejele apiksaban, se farmakokinetika andeksaneta alfa pri starejših osebah ni statistično razlikovala od tiste pri mlajših osebah.
English: No clinical evaluation for apixabantreated subjects with high-dose andexanet alfa and no evaluation for rivaroxaban-treated subjects with low-dose andexanet alfa was performed in these studies.
Slovenian: Klinična ocena pri osebah, zdravljenih z apiksabanom, pri velikih odmerkih andeksaneta alfa, in ocena pri osebah, zdravljenih z rivaroksabanom, pri majhnih odmerkih andeksaneta alfa, v teh študijah nista bili izdelani.
English: Among the apixaban-treated subjects in Study 14-503, the percent change in anti-FXa activity was -92.34% (± 2.809%) for the andexanet alfa group and -32.70% (± 5.578%) for the placebo group (p < 0.0001), the latter reflecting the intrinsic clearance of the anticoagulant.
Slovenian: Med osebami, zdravljenimi z apiksabanom v študiji 14-503, je odstotna sprememba aktivnosti proti FXa znašala -92,34 % (± 2,809 %) v skupini, zdravljeni z andeksanetom alfa, in -32,70 % (± 5,578 %) v skupini, zdravljeni s placebom (p < 0,0001), pri čemer je zadnja odražala intrinzični očistek antikoagulanta.
English: Table 4: List of adverse reactions in healthy subjects and bleeding patients System organ class/ Preferred term
Slovenian: Preglednica 4: Seznam neželenih učinkov pri zdravih osebah in bolnikih s krvavitvijo
English: Once all required vials are reconstituted, the reconstituted solution is withdrawn from each vial, using the large volume (60 mL or larger) syringe equipped with a 20 gauge (or larger) needle.
Slovenian: Po rekonstituciji vseh potrebnih vial je treba iz vsake viale povleči rekonstituirano raztopino z veliko injekcijsko brizgo (60 ml ali večjo), opremljeno z iglo velikosti 20 (ali večjo).
English: Administration using a syringe pump
Slovenian: Dajanje z uporabo črpalke za brizgo
English: In order to substantiate correlation of the biomarker (antiFXa-activity) with haemostatic efficacy and clarify the risk of thromboses and thromboembolic events, the MAH should submit the results of a global randomised controlled clinical trial to investigate the use of andexanet versus standard of care treatment in patients with intracranial haemorrhage (ICH) taking apixaban, rivaroxaban, or edoxaban (study 18-513).
Slovenian: Za utemeljitev korelacije med biološkim označevalcem (delovanjem proti FXa) in hemostatsko učinkovitostjo ter razjasnitev tveganja za tromboze in trombembolične dogodke mora imetnik dovoljenja za promet z zdravilom predložiti rezultate globalnega randomiziranega nadzorovanega kliničnega preskušanja za raziskavo uporabe andeksaneta v primerjavi s standardnim zdravljenjem pri bolnikih z intrakranialno krvavitvijo (ICH), ki jemljejo apiksaban, rivaroksaban ali edoksaban
English: Reversing FXa inhibitor therapy exposes patients to the thrombotic risk of their underlying disease.
Slovenian: Odprava učinka zdravljenja z zaviralci FXa izpostavi bolnike tveganju za trombozo zaradi osnovne bolezni.
English: High dose
Slovenian: Velik odmerek
English: Once all required vials are reconstituted, withdraw the reconstituted solution from each vial, using the large volume (60 mL or larger) syringe equipped with a 20 gauge (or larger) needle.
Slovenian: Po rekonstituciji vseh potrebnih vial iz vsake viale povlecite rekonstituirano raztopino z veliko injekcijsko brizgo (60 ml ali večjo), opremljeno z iglo velikosti 20 G (ali večjo).
English: At the time of the event 10/36 (27.8%) patients were on antithrombotic therapy.
Slovenian: Ob času dogodka je 10 bolnikov od 36 bolnikov (27,8 %) prejemalo antikoagulacijsko zdravljenje.
English: Patients being treated with FXa inhibitor therapy have underlying disease states that predispose them to thromboembolic events.
Slovenian: Bolniki, zdravljeni z zaviralci FXa, imajo osnovna bolezenska stanja, zaradi katerih so nagnjeni k trombotičnim dogodkom.
English: Attach ancillary equipment (i.e., extension tubing, air filters, syringe driver) in preparation for administration.
Slovenian: Med pripravo na dajanje zdravila priključite pomožno opremo (npr. cevne podaljške, zračne filtre, črpalko za infuzijo).
English: Administer the reconstituted solution at the appropriate rate.
Slovenian: Z ustrezno hitrostjo aplicirajte rekonstituirano raztopino.
English: While it is permissible to combine the bolus and infusion into a single IV bag, to ensure the correct administration rate, it is recommended that the bolus and infusion are split into two separate bags.
Slovenian: Čeprav je dovoljeno bolus in infuzijo združiti v isti vrečki za infuzijo, se priporoča, da za zagotovitev pravilne hitrosti infundiranja bolus in infuzijo ločite v dve vrečki.
English: FXa inhibitors did not affect andexanet alfa pharmacokinetics at therapeutic levels.
Slovenian: Zaviralci FXa pri terapevtskih ravneh niso vplivali na farmakokinetiko andeksaneta alfa.
English: After an appropriate number of vials of Ondexxya has been reconstituted, the reconstituted solution (10 mg/mL) is transferred to a suitable empty intravenous bag comprised of polyolefin (PO) or polyvinyl chloride (PVC) material without further dilution (see section 6.6) prior to administration by IV infusion using a 0.2 or 0.22 micron in-line polyethersulfone (PES) or equivalent low proteinbinding filter.
Slovenian: Po rekonstituciji ustreznega števila vial zdravila Ondexxya se rekonstituirana raztopina (10 mg/ml) brez nadaljnjega redčenja prenese v primerno prazno vrečko za intravensko infuzijo, izdelano iz poliolefina (PO) ali polivinilklorida (PVC) (glejte poglavje 6.6), čemur sledi i.v.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.
Slovenian: Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji zdravila.
English: Ondexxya is supplied in glass vials as a white to off-white powder for solution for infusion, which is reconstituted (dissolved) before use.
Slovenian: Izgled zdravila Ondexxya in vsebina pakiranja Zdravilo Ondexxya je na voljo v steklenih vialah v obliki belega do umazano belega praška za raztopino za infundiranje, ki ga je treba pred uporabo rekonstituirati (raztopiti).
English: Using a 20 mL (or larger) syringe and a 20 gauge (or larger) needle, withdraw 20 mL of water for injections.
Slovenian: V 20-ml (ali večjo) injekcijsko brizgo z iglo velikosti 20 G (ali večjo) povlecite 20 ml vode za injekcije.
English: Bolus strengths of andexanet alfa being necessary to achieve mean unbound apixaban (400 mg bolus) and unbound rivaroxaban concentrations (800 mg bolus) below the anticipated respective threshold for no anticoagulant effect were twice as high for rivaroxaban (20 mg QD) compared to apixaban (5 mg BID), due to the differential PK characteristics and dose levels of respective FXa inhibitor.
Slovenian: Bolusni odmerki andeksaneta alfa, potrebni za znižanje povprečnih koncentracij nevezanega apiksabana (400-mg bolus) in nevezanega rivaroksabana (800-mg bolus) pod ustrezno pričakovano mejno vrednost za odsotnost antikoagulacijskega učinka, so bili pri rivaroksabanu dvakrat večji
English: Andexanet alfa binds direct FXa inhibitors with high affinity, making them unavailable to exert their anticoagulant effects.
Slovenian: Andeksanet alfa z veliko afiniteto veže neposredne zaviralce FXa in jim s tem prepreči antikoagulacijsko delovanje.
English: • disturbance of taste
Slovenian: • motnje okušanja,
English: Submission of the final CSR by 30
Slovenian: Predložitev končnega poročila klinične študije do
English: Among the rivaroxaban-treated subjects in Study 14-504, the percent change in anti-FXa activity was -96.72% (± 1.838%) for the andexanet alfa group and -44.75% (± 11.749%) for the placebo group (p < 0.0001 ), the latter reflecting the intrinsic clearance of the anticoagulant.
Slovenian: FXa znašala -96,72 % (± 1,838 %) v skupini, zdravljeni z andeksanetom alfa, in -44,75 % (± 11,749 %) v skupini, zdravljeni s placebom (p < 0,0001), pri čemer je zadnja odražala intrinzični očistek antikoagulanta.
English: Powder for solution for infusion 4 x 1 vial of 200 mg
Slovenian: 4 × 1 viala z 200 mg
English: No thromboembolic events were observed in 223 healthy volunteers who received FXa inhibitors and were treated with andexanet alfa.
Slovenian: Pri 223 zdravih prostovoljcih, ki so prejeli zaviralce FXa in zdravljenje z andeksanetom alfa, niso opazili trombemboličnih dogodkov.
English: The 30-day mortality rates were 16.2% (37/229) in patients presenting with ICH, 12.8% (12/94) with GI bleeding, and 17.9% (5/28) with other types of bleeding.
Slovenian: 12,8-odstotna (12/94) in pri bolnikih z drugimi vrstami krvavitev 17,9-odstotna (5/28).
English: Andexanet alfa is administered as an intravenous bolus at a target rate of approximately 30 mg/min over 15 minutes (low dose) or 30 minutes (high dose), followed by administration of a continuous infusion of 4 mg/min (low dose) or 8 mg/min (high dose) for 120 minutes (see table 1).
Slovenian: Andeksanet alfa se daje v obliki intravenskega bolusa s ciljno hitrostjo približno 30 mg/min v trajanju 15 minut (majhen odmerek) ali 30 minut (velik odmerek), ki mu sledi aplikacija kontinuirane infuzije 4 mg/min (majhen odmerek) ali 8 mg/min (velik odmerek) v trajanju 120 minut (glejte preglednico 1).
English: In clinical trials of patients with life-threatening bleeding, fever and stroke may affect up to 1 in 10 people; transient ischaemic attack (TIA), heart attack, and blood clots in the legs or lungs may affect up to 1 in 100 people (uncommon side effects).
Slovenian: Prehodni ishemični napad (TIA), srčni napad in krvni strdki v nogah ali pljučih se lahko pojavijo pri največ 1 bolniku od 100 bolnikov (občasni neželeni učinki).
English: No dose-limiting toxicities have been observed during clinical trials.
Slovenian: Med kliničnimi preskušanji niso opazili toksičnosti, ki bi omejevale odmerek.
English: Your doctor may decide to give you Ondexxya to rapidly reverse the effects of the anticoagulant in case of a life-threatening or uncontrolled bleeding situation.
Slovenian: Zdravnik se bo v primeru smrtno nevarne ali neobvladane krvavitve morda odločil, da vam da zdravilo Ondexxya za hitro odpravo učinkov antikoagulanta.
English: Portola Netherlands B.V. Prins Bernhardplein 200 1097 JB Amsterdam Netherlands
Slovenian: 1097 JB Amsterdam Nizozemska
English: Apixaban
Slovenian: Dojenje
English: Medical judgement should balance the benefits of anticoagulation with the risks of re-bleeding (see section 4.4).
Slovenian: Pri medicinski presoji je treba ustrezno upoštevati koristi antikoagulacije in tveganja ponovne krvavitve
English: How Ondexxya is used
Slovenian: Kako uporabljati zdravilo Ondexxya
English: Ondexxya 200 mg powder for solution for infusion
Slovenian: IME ZDRAVILA Ondexxya 200 mg prašek za raztopino za infundiranje
English: • nausea (feeling sick)
Slovenian: • siljenje na bruhanje (navzea),
English: FXa inhibitor
Slovenian: Zaviralec FXa
English: Ondexxya 200 mg powder for solution for infusion andexanet alfa
Slovenian: IME ZDRAVILA Ondexxya 200 mg prašek za raztopino za infundiranje andeksanet alfa