FrancophonIA/ELRC3.0 huggingface dataset:
English: Use aseptic technique during the reconstitution procedure.
Slovenian: Med postopkom rekonstitucije uporabljajte aseptično tehniko.
English: Non-cardiovascular deaths (n=27) included: respiratory failure (n=5), infection/sepsis (n=5), accident/trauma (n=2), cancer (n=1), and other/non-vascular cause (n=14).
Slovenian: Ne-srčno-žilne smrti (n = 27) so zajemale: dihalno odpoved (n = 5), okužbo/sepso (n = 5), nesrečo/travmo (n = 2), raka (n = 1) in druge/nežilne vzroke (n = 14).
English: Restoration of thrombin generation following administration was dose- and dose-regimen-dependent and did not correlate with anti-FXa-activity beyond approximately four hours (see below, “restoration of thrombin generation”).
Slovenian: Obnova tvorbe trombina po dajanju je bila odvisna od odmerka in sheme odmerjanja in po preteku približno štirih ur ni več korelirala z aktivnostjo proti FXa (glejte v nadaljevanju: »Obnova tvorbe trombina«).
English: Submission of the final CSR by 30 June
Slovenian: Predložitev končnega poročila klinične študije do 30. junija 2021
English: In order to further confirm the posology of Ondexxya, the MAH should submit the results of a comparative PK study with Generation 1, process 3, and Generation 2 material (study 19-514).
Slovenian: Za nadaljnjo potrditev odmerjanja zdravila Ondexxya mora imetnik dovoljenja za promet z zdravilom predložiti rezultate študije primerjave farmakokinetike z materiali 1. generacije, 3. procesa, in materiali 2. generacije (študija 19-514).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with andexanet alfa in one or more subsets of the paediatric population in treatment and prevention of FXa inhibitor-associated haemorrhages (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z andeksanetom alfa pri zdravljenju in preprečevanju krvavitev, povezanih z zaviralci FXa, za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If a syringe driver is used for administration, multiple syringes should be used to contain the final volume of reconstituted product.
Slovenian: Če se za aplikacijo uporablja črpalka za brizgo, je treba uporabiti več injekcijskih brizg, ki bodo vsebovale končni volumen rekonstituiranega zdravila.
English: For subjects on rivaroxaban, high-dose andexanet alfa (bolus plus infusion) resulted in increased thrombin generation above two standard deviations.
Slovenian: Pri osebah, zdravljenih z rivaroksabanom, je velik odmerek andeksaneta alfa (bolus in infuzija) povzročil povečano tvorbo trombina nad dvema standardnima odklonoma.
English: Last dose
Slovenian: Zadnji odmerek
English: Detailed instructions for your doctor or nurse on how to give Ondexxya are given at the end of this package leaflet (see ‘Handling instructions').
Slovenian: Podrobne informacije o dajanju zdravila Ondexxya, namenjene zdravniku ali medicinski sestri, so na koncu tega navodila za uporabo (glejte »Navodila za ravnanje z zdravilom«).
English: Insert the syringe needle through the centre of the rubber stopper.
Slovenian: Vstavite iglo skozi center gumijastega zamaška.
English: Pack size of four vials.
Slovenian: Velikost pakiranja: štiri viale.
English: If needed, the reconstituted solution once transferred into the IV bag can be stored for an additional eight hours at room temperature.
Slovenian: Po potrebi je mogoče rekonstituirano raztopino, ki je bila prenesena v vrečko za infuzijo, pri sobni temperaturi hraniti še dodatnih osem ur.
English: Push the plunger down to slowly inject the 20 mL of water for injections into the vial, directing the stream toward the inside wall of the vial to minimise foaming.
Slovenian: Potisnite bat injekcijske brizge, tako da v vialo počasi injicirate 20 ml vode za injekcije, pri čemer curek usmerite proti notranji steni viale, da kar najbolj zmanjšate penjenje.
English: Name and address of the manufacturer responsible for batch release Portola Netherlands B.V.
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Portola Netherlands B.V.
English: In both, Study 14-503 and Study 14-504, treatment with andexanet alfa also resulted in a statistically significant increase in thrombin generation in healthy subjects anticoagulated with apixaban or rivaroxaban versus placebo (p < 0.0001).
Slovenian: V obeh študijah, študiji 14-503 in študiji 14-504, je zdravljenje z andeksanetom alfa povzročilo tudi statistično značilno povečanje tvorbe trombina pri zdravih osebah, ki so prejemale antikoagulacijsko zdravljenje z apiksabanom in rivaroksabanom v primerjavi s placebom (p < 0,0001).
English: Laboratory parameters as antiFXa activity, endogenous thrombotic potential (ETP), or markers of thrombosis might not be reliable for guidance.
Slovenian: Laboratorijski parametri, kot so aktivnost proti FXa, endogeni trombinski potencial (ETP) ali označevalci tromboze, niso vedno zanesljivo vodilo.
English: For moderate symptoms, consideration may be given to a brief interruption or slowing of the infusion with resumption of the infusion after symptoms subside.
Slovenian: Pri zmernih simptomih je treba razmisliti o kratkotrajni prekinitvi ali upočasnitvi infundiranja in nadaljnjem infundiranju po umiritvi simptomov.
English: The two co-primary endpoints are: a) percent change in anti-FXa activity from baseline to the nadir between five minutes after the end of the bolus until the end of the infusion, and; b) rate of good or excellent (compared to poor or none) haemostatic efficacy within 12 hours after infusion, as rated by an independent endpoint adjudication committee .
Slovenian: Soprimarna opazovana dogodka sta: a) odstotna sprememba aktivnosti proti FXa od izhodišča do nadirja od pet minut po koncu bolusa do konca infuzije in b) stopnja dobre ali odlične hemostatske učinkovitosti (v primerjavi s slabo ali nično) v 12 urah po infundiranju, ki jo je ocenila neodvisna komisija za presojo opazovanih dogodkov.
English: Contents of the pack and other information What Ondexxya contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ondexxya
English: Therefore, dose adjustment is not considered needed for patients with hepatic impairment.
Slovenian: Zato velja, da prilagoditev odmerka pri bolnikih z okvaro jeter ni potrebna.
English: Do not breast-feed your child while you are taking this medicine.
Slovenian: Med jemanjem tega zdravila ne smete dojiti.
English: What you need to know before you receive Ondexxya Do not use Ondexxya:
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Ondexxya Ne uporabite zdravila Ondexxya:
English: Following administration of Ondexxya and cessation of a major bleed, re-anticoagulation should be considered to prevent thrombotic events due to the patient's underlying medical condition.
Slovenian: Po dajanju zdravila Ondexxya in prenehanju večje krvavitve je treba razmisliti o ponovnem začetku antikoagulacijskega zdravljenja za preprečitev trombotičnih dogodkov zaradi bolnikove osnovne bolezni.
English: Headache, cough, or shortness of breath (common side effects which may affect up to 1 in 10 people) happened within a few minutes to a few hours of the infusion.
Slovenian: Glavobol, kašelj ali kratka sapa (pogosti neželeni učinki, ki se lahko pojavijo pri največ 1 bolniku od 10 bolnikov) so se pojavili od nekaj minut do nekaj ur po infundiranju.
English: Andexanet alfa is not suitable for pre-treatment of urgent surgery.
Slovenian: Andeksanet alfa ni primeren za predzdravljenje pri nujnih kirurških posegih.
English: Once reconstituted, Ondexxya is for immediate use.
Slovenian: Po rekonstituciji je zdravilo Ondexxya namenjeno za takojšnjo uporabo.
English: The volume of distribution at steady state (Vdss) and volume of distribution (Vd) at sub-therapeutic levels decreased with dose, consistent with the saturation of a high-affinity compartment, likely to reflect binding to endothelial cell bound TFPI, the only endogenous molecule known to bind andexanet alfa.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja (Vdss) in volumen porazdelitve (Vd) pri ravneh, nižjih od terapevtskih, se je zmanjševal z odmerkom, skladno z nasičenostjo predelka z veliko afiniteto, kar verjetno odraža vezavo na TFPI, vezan na celice endotelija, ki je edina endogena molekula, za katero je znano, da veže andeksanet alfa.
English: Preliminary data suggest higher risk of thrombosis for patients receiving the higher dose of andexanet, previous lower dose of the anti-FXa inhibitor, and patients on rivaroxaban.
Slovenian: Predhodni podatki kažejo na večje tveganje za trombozo pri bolnikih, ki prejmejo večji odmerek andeksaneta ali predhoden manjši odmerek zaviralca FXa, in pri bolnikih, zdravljenih z rivaroksabanom.
English: Based on population pharmacokinetics analysis, gender does not have a clinically meaningful effect on the pharmacokinetics of andexanet alfa.
Slovenian: Spol Na podlagi analize populacijske farmakokinetike spol nima klinično pomembnega učinka na farmakokinetiko andeksaneta alfa.
English: To prevent the inadvertent transfer of air, be careful to hold the syringe needle up, and do not set the syringe down between multiple withdrawals from vials.
Slovenian: Da se prepreči nehoten prenos zraka, morate paziti, da boste injekcijsko brizgo držali obrnjeno z iglo navzgor, med posameznimi odvzemi raztopine iz vial pa je ne smete odložiti.
English: Andexanet alfa will not reverse the effects of non-FXa inhibitors (see section 5.1).
Slovenian: Andeksanet alfa ne odpravi učinkov zaviralcev, ki ne zavirajo FXa (glejte poglavje 5.1).
English: Diphenhydramine may be administered.
Slovenian: Lahko se aplicira difenhidramin.
English: Andexanet alfa has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Andeksanet alfa nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Ondexxya is not recommended during pregnancy or if you have the potential to become pregnant and are not using birth control.
Slovenian: Zdravilo Ondexxya se ne priporoča med nosečnostjo ali če pri vas obstaja možnost zanositve in ne uporabljate kontracepcije.
English: > 5 mg/ Unknown
Slovenian: > 5 mg/ neznano
English: • Intravenous PO or PVC bag (150 mL or larger) to contain the final volume of reconstituted product (if administration is performed with an IV bag).
Slovenian: • Vrečko za infuzijo iz PO ali PVC (150 ml ali večjo), ki bo vsebovala končni volumen rekonstituiranega zdravila (če se za infuzijo uporablja vrečka za intravensko infuzijo).
English: Most patients had previously received either apixaban (194/352; 55.1%) or rivaroxaban (128/352; 36.4%), and experienced either an ICH (230/352; 65.3%) or a gastrointestinal (GI) bleed (94/352; 26.7%).
Slovenian: Večina bolnikov je predhodno prejela apiksaban (194/352; 55,1 %) ali rivaroksaban (128/352; 36,4 %) in imela intrakranialno (230/352; 65,3 %) ali gastrointestinalno krvavitev (94/352; 26,7 %).
English: For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Slovenian: Za odrasle bolnike, zdravljene z neposrednimi zaviralci faktorja Xa (FXa) (apiksabanom ali rivaroksabanom), ko je potrebna odprava antikoagulacije zaradi smrtno nevarne ali neobvladane krvavitve.
English: Phase II studies of andexanet alfa in the presence of direct FXa inhibitors demonstrated the same dose proportional pharmacokinetics over the intended therapeutic dose range evaluated for both Cmax and area under the curve (AUC) with an effective half-life of approximately one hour.
Slovenian: faze z andeksanetom alfa v prisotnosti neposrednih zaviralcev FXa so pokazale enako z odmerkom sorazmerno farmakokinetiko v celotnem predvidenem terapevtskem razponu odmerkov, v katerem so ocenili Cmax in površino pod krivuljo (AUC), z efektivnim razpolovnim časom približno eno uro.
English: If you suffer side effects when you are being given Ondexxya by infusion (drip), your doctor may decide to slow down or pause your treatment.
Slovenian: Če imate kakršne koli neželene učinke, ko dobivate zdravilo Ondexxya prek (kapalne) infuzije, se bo zdravnik morda odločil za zmanjšanje hitrosti ali začasno prekinitev infundiranja.
English: The maximal reversal of anti-FXa activity was achieved within two minutes of completing the bolus administration.
Slovenian: Največja odprava aktivnosti proti FXa je bila dosežena v dveh minutah po koncu dajanja bolusa.
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate after completion of treatment.
Slovenian: Za zmanjšanje tega tveganja je treba razmisliti o ponovni uvedbi antikoagulacijskega zdravljenja, takoj ko je to po zaključku zdravljenja medicinsko primerno.
English: In the ANNEXA-4 study, 36 (10.3%) patients experienced a total of 42 thromboembolic events: cerebrovascular accident (CVA) (15/42; 35.7%), deep venous thrombosis (13/42; 33.1%), acute myocardial infarction (8/42; 19.0%), pulmonary embolism (5/42; 11.9%), and transient ischaemic attack (1/42; 2.4%).
Slovenian: V študiji ANNEXA-4 je 36 bolnikov (10,3 %) imelo skupno 42 trombemboličnih dogodkov: cerebrovaskularni inzult (CVA) (15/42; 35,7 %), globoko vensko trombozo (13/42; 33,1 %), akutni miokardni infarkt (8/42; 19,0 %), pljučno embolijo (5/42; 11,9 %) in prehodni ishemični napad (1/42; 2,4 %).
English: 345 andexanet alfa-treated healthy subjects were tested for antibodies cross reacting with andexanet alfa and antibodies to factor X and FXa.
Slovenian: Pri 345 zdravih osebah, zdravljenih z andeksanetom alfa, so testirali na navzkrižno reagiranje protiteles z andeksanetom alfa ter na protitelesa proti faktorju X in FXa.
English: Clinical efficacy is based upon reversal of anti-FXa-activity in healthy volunteers dosed with apixaban or rivaroxaban.
Slovenian: Podatki o klinični učinkovitosti temeljijo na odpravi aktivnosti proti FXa pri zdravih prostovoljcih, ki so prejeli apiksaban ali rivaroksaban.
English: Table 4 provides the list of adverse reactions from clinical studies of healthy subjects treated with andexanet alfa.
Slovenian: Preglednica 4 vsebuje seznam neželenih učinkov iz kliničnih študij pri zdravih osebah, ki so prejele andeksanet alfa.
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.
Slovenian: Za zmanjšanje tega tveganja je treba razmisliti o ponovni uvedbi antikoagulacijskega zdravljenja, takoj ko je to medicinsko primerno.
English: In the clinical trials in healthy subjects administered an FXa inhibitor and then receiving andexanet alfa, no serious or severe adverse reactions were reported.
Slovenian: V kliničnih preskušanjih, kjer so zdrave osebe prejele zaviralec FXa in nato andeksanet alfa, niso poročali o resnih ali hudih neželenih učinkih.
English: The following are needed before starting reconstitution:
Slovenian: Pred začetkom rekonstitucije je treba pripraviti naslednje:
English: Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Based on the existing data on clearance, no dose adjustment is recommended.
Slovenian: Na podlagi obstoječih podatkov o očistku prilagoditev odmerka ni potrebna.
English: Compared with patients recruited in North America, EU patients were significantly older (79.0 years vs. 76.3 years), more frequently had ICH as index event (72.9% vs. 59.0%) and more ICHs were intraparenchymal (54.9% vs. 34.4%).
Slovenian: V primerjavi z bolniki, vključenimi v Severni Ameriki, so bili bolniki v EU pomembno starejši (79,0 leta v primerjavi s 76,3 leta), pogosteje so imeli ICH kot začetni dogodek (72,9 % v primerjavi z 59,0 %) in več primerov ICH je bilo intraparenhimskih (54,9 % v primerjavi s 34,4 %).
English: Table 3: Summary of dosing for reversal of rivaroxaban
Slovenian: Preglednica 3: Povzetek odmerjanja za odpravo učinka rivaroksabana
English: The effects of andexanet alfa can be measured through pharmacodynamic markers, including anti-FXa activity, and free fraction of available FXa inhibitor as well as through restoration of thrombin generation.
Slovenian: Učinke andeksaneta alfa je mogoče meriti s farmakodinamičnimi označevalci, vključno z aktivnostjo proti FXa, prosto frakcijo razpoložljivega zaviralca FXa ter obnovo tvorbe trombina.
English: Based on the available PK data, andexanet alfa has little to no renal clearance, and thus would not require dose adjustment for patients with renal impairment.
Slovenian: Na podlagi razpoložljivih FK podatkov je ledvični očistek andeksaneta alfa majhen do ničen, kar bi pomenilo, da prilagoditev odmerka pri bolnikih z okvaro ledvic ni potrebna.
English: The predominant mechanism of action is the binding and sequestration of the FXa inhibitor, although there may be a minor contribution from the inhibition of tissue factor pathway inhibitor (TFPI) activity through binding to TFPI.
Slovenian: Prevladujoči mehanizem delovanja je vezava in sekvestracija zaviralca FXa, možno pa je, da v majhni meri prispeva tudi zaviranje delovanja zaviralca poti tkivnega faktorja (TFPI) z vezavo na TFPI.
English: Timing of FXa inhibitor last dose before andexanet alfa initiation
Slovenian: Čas zadnjega odmerka zaviralca FXa pred uvedbo andeksaneta alfa
English: Based on data from 352 patients from the Phase IIIb/IV ANNEXA-4 study treated with an FXa inhibitor and experiencing an acute major bleeding episode, one patient experienced a serious or severe infusion-related reaction.
Slovenian: Na podlagi podatkov 352 bolnikov iz študije faze IIIb/IV ANNEXA-4, zdravljenih z zaviralcem FXa, ki so imeli epizodo večje akutne krvavitve, je en bolnik imel resno ali hudo reakcijo, povezano z infuzijo.
English: Timing of last dose before Ondexxya initiation
Slovenian: Čas zadnjega odmerka pred uvedbo zdravila Ondexxya
English: Use andexanet alfa within eight hours after reconstitution when stored at room temperature.
Slovenian: Andeksanet alfa uporabite v osmih urah po rekonstituciji, če je rekonstituirana raztopina shranjena pri sobni temperaturi.
English: This is based on the specific anticoagulant medicine you take as well as on the dose and the time since your last dose of anticoagulant medicine.
Slovenian: Ta je odvisna od zdravila proti koagulaciji, ki ga jemljete, ter velikosti odmerka in časa, ko ste vzeli zadnji odmerek zdravila proti koagulaciji.
English: FXa inhibitor last dose
Slovenian: Zaviralec FXa Zadnji odmerek
English: After reconstitution, each mL of solution contains 10 mg of andexanet alfa.
Slovenian: Po rekonstituciji en ml raztopine vsebuje 10 mg andeksaneta alfa.
English: Reconstitute each vial according to the following instructions: 1.
Slovenian: Vsako vialo rekonstituirajte skladno z naslednjimi navodili:
English: Andexanet alfa is not recommended during pregnancy or in women of childbearing potential not using contraception.
Slovenian: Andeksaneta alfa ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: • Same number of 20 mL (or larger) solvent syringes equipped with a 20 gauge (or larger) needle.
Slovenian: • Enako število 20 ml (ali večjih) injekcijskih brizg s topilom, opremljenih z iglo velikosti 20 (ali večjo).
English: The primary endpoint for both Study 14-503 (apixaban) and Study 14-504 (rivaroxaban) was the percent change in anti-FXa activity from baseline to post-infusion nadir.
Slovenian: Primarni opazovani dogodek za študijo 14-503 (apiksaban) in študijo 14-504 (rivaroksaban) je bila odstotna sprememba aktivnosti proti FXa od izhodišča do nadirja po infundiranju.
English: The time courses of anti-FXa activity before and after andexanet alfa administration are shown in Figure 1.
Slovenian: Časovni poteki aktivnosti proti FXa pred dajanjem andeksaneta alfa in po njem so prikazani na sliki 1.
English: Dose-dependent increases in coagulation markers F1+2, TAT, and D-dimers after administration of andexanet alfa were observed, but these markers were not measured in patients enrolled in the ANNEXA-4 study, and their relevance in bleeding patients is not known.
Slovenian: Po dajanju andeksaneta alfa so opazili od odmerka odvisna povečanja ravni označevalcev koagulacije F1 + 2, TAT in D-dimera, vendar teh označevalcev niso izmerili pri bolnikih, vključenih v študijo ANNEXA-4, in njihov pomen za bolnike s krvavitvijo ni znan.
English: Use within eight hours after reconstitution when stored at room temperature.
Slovenian: Uporabite v osmih urah po rekonstituciji, če je rekonstituirana raztopina shranjena pri sobni temperaturi.
English: The 30-day mortality rates were 20.1% (44/219) in patients aged > 75 years old and 7.6% (10/132) in patients aged ≤ 75 years.
Slovenian: 30-dnevna stopnja smrtnosti je bila 20,1 % (44/219) pri bolnikih, starih > 75 let, in 7,6 % (10/132) pri bolnikih,
English: Administration using a syringe pump 1.
Slovenian: Dajanje z uporabo črpalke za brizgo 1.
English: The occurrence of thromboembolic events was generally comparable between patients > 75 years (11.0%; 24/219) and those ≤ 75 years of age (9.1%; 12/132).
Slovenian: Pojavljanje trombemboličnih dogodkov je bilo na splošno primerljivo pri bolnikih, starih > 75 let (11,0 %; 24/219), in bolnikih, starih ≤ 75 let (9,1 %; 12/132).
English: What Ondexxya is and what it is used for
Slovenian: Kaj je zdravilo Ondexxya in za kaj ga uporabljamo
English: It is unknown whether andexanet alfa is excreted in human milk.
Slovenian: Ni znano, ali se andeksanet alfa izloča v materino mleko.
English: Hepatic impairment: Based on the existing data on clearance of andexanet alfa, no dose adjustment is recommended.
Slovenian: Okvara jeter: Na podlagi obstoječih podatkov o očistku andeksaneta alfa prilagoditev odmerka ni potrebna.
English: Repeat steps 1 and 2 as necessary to transfer the complete volume of the bolus and the infusion into an IV bag.
Slovenian: Ponavljajte 1. in 2. korak, dokler ne prenesete celotnega volumna bolusa in infuzije v vrečko za infuzijo.
English: From a microbiological point of view, once opened, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika velja, da je treba zdravilo uporabiti takoj po odprtju.
English: Median change from baseline to nadir in anti-FXa activity was -93.4% (95% CI -94.3%, -92.4%) for apixaban, and -92.5% (95% CI -94.2%, -90.3%) for rivaroxaban.
Slovenian: Mediana sprememba aktivnosti proti FXa od izhodišča do nadirja je bila -93,4 % (95-% IZ -94,3 %, -92,4 %) pri apiksabanu in -92,5 % (95-% IZ -94,2 %, -90,3 %) pri rivaroksabanu.
English: There is no clinical experience with overdose of andexanet alfa.
Slovenian: Kliničnih izkušenj s prevelikim odmerjanjem andeksaneta alfa ni.
English: Powder for solution for infusion White to off-white lyophilized powder
Slovenian: FARMACEVTSKA OBLIKA Prašek za raztopino za infundiranje Bel do umazano bel liofiliziran prašek
English: Andexanet alfa reverses the anticoagulant effect of direct factor Xa (FXa) inhibitor products (apixaban, rivaroxaban) only.
Slovenian: Andeksanet alfa odpravi samo antikoagulacijski učinek zdravil za neposredno zaviranje faktorja Xa (FXa) (apiksabana, rivaroksabana).
English: 800 mg at a target rate of 30 mg/min
Slovenian: Velik odmerek 800 mg pri ciljni hitrosti 30 mg/min
English: Reversal of rivaroxaban
Slovenian: Odprava učinka rivaroksabana
English: Table 2: Summary of dosing for reversal of apixaban
Slovenian: Preglednica 2: Povzetek odmerjanja za odpravo učinka apiksabana
English: What you need to know before you receive Ondexxya 3.
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Ondexxya
English: 400 mg at a target rate of 30 mg/min
Slovenian: Majhen odmerek 400 mg pri ciljni hitrosti 30 mg/min
English: This medicine has been designed to reverse the effects of factor Xa inhibitor medicines only.
Slovenian: To zdravilo je bilo izdelano samo za odpravo učinkov zdravil za zaviranje faktorja Xa.