FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: FXa pokazala su jednaku farmakokinetiku proporcionalnu dozi za ciljni terapijski raspon doza procijenjeno za Cmax i površinu ispod krivulje (AUC) s efektivnim poluvijekom djelovanja od otprilike jednog sata.
English: 345 andexanet alfa-treated healthy subjects were tested for antibodies cross reacting with andexanet alfa and antibodies to factor X and FXa.
Croatian: U 345 zdravih ispitanika koji su primali andeksanet alfa ispitana je prisutnost križno reagirajućih antitijela na andeksanet alfa i antitijela na FX i FXa.
English: Paediatric population The pharmacokinetics of andexanet alfa has not been studied in paediatric patients.
Croatian: Pedijatrijska populacija Farmakokinetika andeksaneta alfa nije ispitana u pedijatrijskih bolesnika.
English: After you have received Ondexxya, your doctor will decide when to restart your anticoagulant treatment.
Croatian: Nakon što ste primili Ondexxyu liječnik će odrediti kada ćete ponovno započeti s uzimanjem terapije protiv zgrušavanja krvi.
English: These levels of unbound FXa inhibitor provide little or no anticoagulant effect.
Croatian: FXa imaju mali ili uopće nemaju antikoagulantni učinak.
English: Andexanet alfa reverses the anticoagulant effect of direct factor Xa (FXa) inhibitor products (apixaban, rivaroxaban) only.
Croatian: Andeksanet alfa poništava antikoagulantni učinak samo onih lijekova koji su direktni inhibitori faktora Xa (FXa) (apiksaban, rivaroksaban).
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.
Croatian: Na temelju dostupnih farmakokinetičkih podataka, andeksanet alfa ima mali do nikakav bubrežni klirens, te stoga nije potrebno prilagođavanje doze za bolesnike s oštećenom funkcijom bubrega.
English: Annex IV Conclusions on the granting of the conditional marketing authorisation presented by the European Medicines Agency
Croatian: ZAKLJUČCI EUROPSKE AGENCIJE ZA LIJEKOVE O DAVANJU UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Restoration of thrombin generation to within normal ranges (defined as one standard deviation from baseline levels) within two minutes and maintained for 20 hours was achieved with bolus only and bolus plus infusion for low-dose andexanet alfa in subjects on apixaban.
Croatian: Oporavak stvaranja trombina do vrijednosti unutar normalnog raspona (definirana kao jedna standardna devijacija od početnih vrijednosti) unutar dvije minute i održana tijekom 20 sati postignuta je samo primjenom bolusa i primjenom bolusa i infuzije niske doze andeksaneta alfa u ispitanika koji su primali apiksaban.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva Svrbež često
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.
Croatian: 4. Iako je dopušteno kombinirati bolus i infuziju u jednoj vrećici za i.v. infuziju, preporučuje se bolus i infuziju podijeliti u dvije odvojene vrećice za infuziju, radi osiguranja ispravne brzine primjene.
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).
Croatian: 3. Zbog dodanog volumena, bolusi velikog volumena i infuzije moraju se odvojiti u dodatnim štrcaljkama (2 štrcaljke za bolus i 2 štrcaljke za infuziju).
English: This medicine is for hospital use only.
Croatian: Ovo je lijek samo za primjenu u bolnici.
English: Reconstitute each vial according to the following instructions: 1.
Croatian: Svaku bočicu rekonstituirajte prema sljedećim uputama:
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.
Croatian: Nakon što se rekonstituira odgovarajući broj bočica Ondexxye, rekonstituirana otopina (10 mg/ml) prenese se u odgovarajuću praznu vrećicu za intravensku primjenu lijekova načinjenu od poliolefina (PO) ili polivinilklorida (PVC) bez dodatnog razrjeđivanja (vidjeti dio 6.6) prije primjene intravenskom infuzijom pomoću sustava za infuziju s filtrom od polietersulfona (PES) s veličinom pora od 0,2 ili 0,22 mikrometra s niskim vezanjem proteina ili ekvivalentnim filtrom.
English: 800 mg at a target rate of 30 mg/min
Croatian: Visoka doza 800 mg s ciljnom brzinom primjene od 30 mg/min
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).
Croatian: Kardiovaskularni uzroci smrti (n = 27) uključivali su: hemoragijski moždani udar (n = 6), ishemijski moždani udar (n = 5), iznenadnu srčanu smrt (uključujući i onu koja je nastupila bez prisutnosti drugih osoba) (n = 5), kardiomehaničko zatajenje srca kao pumpe (n = 4), infarkt miokarda (n = 2), drugo krvarenje isključujući hemoragijski moždani udar (n = 1) i druge kardiovaskularne uzroke (n = 4).
English: Renal impairment: The effect of renal impairment on andexanet alfa exposure levels has not been evaluated.
Croatian: Oštećenje funkcije bubrega: Učinak oštećene funkcije bubrega na izloženost andeksanetu alfa nije ispitana.
English: It is unknown if andexanet alfa is excreted in human milk.
Croatian: Nije poznato izlučuje li se andeksanet alfa u majčino mlijeko.
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.
Croatian: Drugi stupac prikazuje popis nuspojava na temelju interim rezultata dobivenih tijekom faze IIIb/IV ispitivanja ANNEXA-4, koja je uključivala 352 bolesnika s velikim akutnim krvarenjem liječena andeksanetom alfa.
English: This medicine has been designed to reverse the effects of factor Xa inhibitor medicines only.
Croatian: Ovaj je lijek osmišljen samo za poništavanje djelovanja inhibitora faktora Xa.
English: Due to the additional volume, the high dose bolus and infusion will need to be further separated into additional syringes (two syringes apiece for bolus and infusion).
Croatian: 3. Zbog dodanog volumena, bolusi velikog volumena i infuzije morat će se odvojiti u dodatne štrcaljke (2 štrcaljke za bolus i 2 štrcaljke za infuziju).
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.
Croatian: 4. Iako je dopušteno kombinirati bolus i infuziju u jednoj vrećici za i.v. infuziju, radi osiguranja ispravne brzine primjene preporučuje se bolus i infuziju podijeliti u dvije odvojene vrećice za infuziju.
English: Restricted to hospital use only.
Croatian: Samo za primjenu u bolnici.
English: Dysgeusia common
Croatian: Disgeuzija često
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.
Croatian: FXa radi utvrđivanja doze potrebne za reverziju; 2) dva ispitivanja faze III, jedno s apiksabanom i drugo s rivaroksibanom radi potvrđivanja djelotvornosti režima doziranja visokih i niskih doza; i 3) globalno, multicentrično, prospektivno, otvoreno ispitivanje faze IIIb/IV (ANNEXA4) u bolesnika s epizodom velikog akutnog krvarenja koje zahtijeva hitnu reverziju antikoagulacije direktnim inhibitorima Fxa.
English: No interaction studies with andexanet alfa have been performed.
Croatian: Nisu provedena ispitivanja interakcija s andeksanetom alfa.
English: Reversal of apixaban
Croatian: Reverzija apiksabana
English: Pack size of four vials.
Croatian: Pakiranje s četiri bočice.
English: Attach ancillary equipment (i.e., extension tubing, air filters, syringe driver) in preparation for administration.
Croatian: 5. Spojite dodatni pribor (npr. produžne infuzijske linije, zračne filtre, pokretač štrcaljke) i pripremite za primjenu.
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.
Croatian: U zdravih dobrovoljaca nakon primjene andeksaneta alfa primijećen je o dozi ovisan porast biljega koagulacije F1+2, TAT i D-dimera, ali nije zabilježen tromboembolijski događaj.
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.
Croatian: Među ispitanicima koji su primali rivaroksaban u ispitivanju 14-504, postotna promjena anti-FXa aktivnosti bila je -96,72% (± 1,838%) za skupinu koja je primila andeksanet alfa i -44,75% (± 11,749%) za skupinu koja je primila placebo (p < 0,0001); potonja vrijednost odražava intrinzični klirens antikoagulansa.
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).
Croatian: U cilju daljnjeg utvrđivanja povezanosti biomarkera (anti-FXa aktivnosti) s hemostatskom djelotvornosti i pojašnjenja rizika za nastanak tromboze i tromboemboličkih događaja, nositelj odobrenja mora podnijeti rezultate globalnog randomiziranog kontroliranog kliničkog ispitivanja primjene andeksaneta u usporedbi sa terapijskim standardom u bolesnika s intrakranijalnim krvarenjem koji primaju apiksaban, rivaroksaban ili edoksaban (ispitivanje 18-513).
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.
Croatian: FXa bilo je brzo (unutar 2 minute od završetka bolusa) i održalo se tijekom trajanja infuzije te se zatim razina postupno s vremenom povisivala, dosežući svoj maksimum otprilike dva sata nakon završetka infuzije.
English: Transfer the reconstituted solution from the syringe into an appropriate IV bag.
Croatian: 2. Prebaciti rekonstituiranu otopinu iz štrcaljke u odgovarajuću vrećicu za intravensku infuziju.
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.
Croatian: Primarna mjera ishoda kako u ispitivanju 14-503 (apiksaban) tako i u ispitivanju 14-504 (rivaroksaban) bila je postotna promjena anti-FXa aktivnosti od početnih vrijednosti do najniže vrijednosti nakon infuzije.
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).
Croatian: • Vrećica od polivinilklorida ili poliolefina (150 ml ili veća) u koju može stati konačni volumen rekonstituiranog lijeka (ako se lijek primjenjuje u obliku i.v. infuzije pomoću vrećice).
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.
Croatian: U cilju daljnjeg utvrđivanja povezanosti biomarkera (anti-FXa aktivnosti) s hemostatskom djelotvornosti i pojašnjenja rizika za nastanak tromboze i tromboemboličkih događaja, nositelj odobrenja za stavljanje lijeka u promet mora podnijeti rezultate ispitivanja ANNEXA-4, intervencijskog nerandomiziranog, multicentričnog, prospektivnog, otvorenog ispitivanja jedne skupine koje se provodi u bolesnika s akutnim velikim krvarenjem.
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Rekonstitucija
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.
Croatian: Među ispitanicima koji su primali apiksaban u ispitivanju 14-503, postotna promjena anti-FXa aktivnosti bila je -92,34% (± 2,809%) za skupinu koja je primila andeksanet alfa i -32,70% (± 5,578%) za skupinu koja je primila placebo (p < 0,0001); potonja vrijednost odražava intrinzični klirens antikoagulansa.
English: Using a 20 mL (or larger) syringe and a 20 gauge (or larger) needle, withdraw 20 mL of water for injection.
Croatian: 3. Pomoću štrcaljke od 20 ml ili veće i igle od 20 G (ili veće) navucite 20 ml vode za injekciju.
English: Excipients: Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose, mannitol, polysorbate 80
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: tris baza, tris hidroklorid, L-arginin hidroklorid, saharoza, manitol, polisorbat 80
English: No thromboembolic events were observed in 223 healthy volunteers who received FXa inhibitors and were treated with andexanet alfa.
Croatian: Izostanak tromboembolijskog događaja zabilježen je u 223 zdrava dobrovoljca koja su primila inhibitore
English: > 10 mg/ Unknown
Croatian: > 10 mg/
English: Cardiac arrest uncommon
Croatian: Srčani arest manje često
English: Limitations of use
Croatian: Ograničenja u primjeni
English: If administration is done with a syringe driver, multiple syringes should be used to contain the final volume of reconstituted product.
Croatian: Ako se primjenjuje pomoću perfuzora, potrebno je koristiti više štrcaljki koje sveukupno sadrže konačni volumen rekonstituiranog lijeka.
English: Use andexanet alfa within eight hours after reconstitution when stored at room temperature.
Croatian: 9. Nakon rekonstitucije, upotrijebite andeksanet alfa unutar 8 sati ako se čuva na sobnoj temperaturi.
English: Ondexxya 200 mg powder for solution for infusion andexanet alfa
Croatian: Ondexxya 200 mg prašak za otopinu za infuziju andeksanet alfa
English: It reverses the effects of certain anticoagulants called factor Xa inhibitors (apixaban or rivaroxaban).
Croatian: Ona poništava djelovanje nekih lijekova protiv zgrušavanja krvi koji se nazivaju inhibitori faktora Xa (apiksaban ili rivaroksaban).
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.
Croatian: Ondexxya je indicirana u odraslih bolesnika liječenih direktnim inhibitorima koagulacijskog faktora Xa (FXa) kada je potrebna reverzija antikoagulacije zbog po život opasnog ili nekontroliranog krvarenja.
English: Hyperhidrosis common
Croatian: Hiperhidroza često
English: If a syringe driver is used for administration, multiple syringes should be used to contain the final volume of reconstituted product.
Croatian: Ako se za primjenu koristi perfuzor, potrebno je koristiti više štrcaljki koje sveukupno sadrže konačni volumen rekonstituiranog lijeka.
English: Handling instructions
Croatian: Upute o rukovanju
English: Andexanet alfa is to be reconstituted and the 10 mg/mL solution then transferred to a suitable IV bag comprised of polyolefin (PO) or polyvinyl chloride (PVC) material without further dilution prior to administration by IV infusion using a 0.2 or 0.22 micron in-line polyethersulfone (PES) or equivalent low protein-binding filter.
Croatian: Andeksanet alfa je potrebno rekonstituirati i potom otopinu u koncentraciji 10 mg/ml prenijeti u odgovarajuću vrećicu za primjenu i.v. infuzije načinjenu od poliolefina (PO) ili polivinilklorida (PVC) bez dodatnog razrjeđivanja prije intravenske primjene pomoću sustava za infuziju s filtrom od polietersulfona (PES) s veličinom pora od 0,2 ili 0,22 mikrometra s niskim vezanjem proteina ili ekvivalentnim filtrom.
English: No dose-limiting toxicities have been observed during clinical trials.
Croatian: Tijekom kliničkih ispitivanja nije primijećena toksičnost koja bi ograničavala dozu.
English: In a similar study, subjects with a median age of 57 years on rivaroxaban 20 mg daily received andexanet alfa (n=26) administered as an 800 mg IV bolus immediately followed by an 8 mg per minute IV infusion for 120 minutes (960 mg) or placebo (n=13).
Croatian: U sličnom ispitivanju ispitanicima s medijanom dobi od 57 godina koji su primali 20 mg rivaroksabana jedanput dnevno primijenjen je andeksanet alfa (n = 26) u obliku intravenskog bolusa od 800 mg nakon kojega je odmah uslijedila i.v. infuzija brzinom od 8 mg u minuti tijekom 120 minuta (960 mg) ili placebo (n = 13).
English: Headache common
Croatian: Glavobolja često
English: Table 4: List of adverse reactions in healthy subjects and bleeding patients System organ class/ Preferred term
Croatian: Tablica 4: Popis nuspojava u zdravih ispitanika i bolesnika s krvarenjem
English: Attach ancillary equipment (i.e., extension tubing, air filters, IV pump) in preparation for administration.
Croatian: 5. Spojite dodatni pribor (npr. produžne infuzijske linije, zračne filtre, infuzomat) i pripremite za primjenu.
English: • if you are allergic to andexanet alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Ondexxyu: - ako ste alergični na andeksanet alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste alergični na proteine hrčka
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.
Croatian: Nakon primjene bolusa andeksaneta alfa, srednja vrijednost koncentracije nevezanog apiksabana iznosila je < 3,5 ng/ml odnosno 4 ng/ml za rivaroksaban, a održana je sve vrijeme trajanja infuzije.
English: Patients being treated with FXa inhibitor therapy have underlying disease states that predispose them to thromboembolic events.
Croatian: Bolesnici koji primaju terapiju inhibitorima FXa boluju od osnovne bolesti koja predstavlja predispoziciju za nastanak tromboembolijskog događaja.
English: Use within eight hours after reconstitution when stored at room temperature.
Croatian: 9. Nakon rekonstitucije, upotrijebiti unutar 8 sati ako se čuva na sobnoj temperaturi.
English: Treatment of patients with more severe ICH with andexanet alfa has not been studied.
Croatian: Liječenje andeksanetom alfa u bolesnika s težim intrakranijalnim krvarenjem nije ispitano.
English: Animal reproductive and developmental studies have not been conducted with andexanet alfa.
Croatian: Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti andeksaneta alfa na životinjama.
English: C/ La Relba s/n
Croatian: Lonza Biologics Porrino, S.L. C/ La Relba s/n
English: Name and address of the manufacturer responsible for batch release Portola Netherlands B.V.
Croatian: Portola Netherlands B.V.
English: Wipe the rubber stopper of each vial with an alcohol swab.
Croatian: Obrisati gumeni čep bočice alkoholnim tupferom.
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - navale crvenila ili osjećaj vrućine
English: Reversal of anticoagulation in healthy subjects aged 50-75 (Studies 14-503 and 14-504) In a prospective, randomized, placebo-controlled study, healthy subjects with a median age of 56.5 years on apixaban 5 mg twice daily received andexanet alfa (n=24) administered as a 400 mg IV bolus immediately followed by a 4 mg per minute IV infusion for 120 minutes (480 mg) or placebo (n=8).
Croatian: U prospektivnom, randomiziranom, placebom kontroliranom ispitivanju u zdravih ispitanika s medijanom dobi od 56,5 godina koji su primali 5 mg apiksabana dva puta dnevno primijenjen je andeksanet alfa (n = 24) u obliku intravenskog bolusa od 400 mg nakon kojega je odmah uslijedila i.v. infuzija brzinom od 4 mg u minuti tijekom 120 minuta (480 mg) ili placebo (n = 8).
English: • Same number of 20 mL (or larger) solvent syringes equipped with a 20 gauge (or larger) needle.
Croatian: • Jednaki broj štrcaljki otapala od 20 ml ili većih s iglom od 20 G ili većom.
English: 4 mg/min for 120 minutes (480 mg)
Croatian: 4 mg/min tijekom 120 minuta
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.
Croatian: Stopa smrtnosti u 30-dnevnom razdoblju bila je 20,1% (44/219) u bolesnika u dobi
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.
Croatian: U ovim ispitivanjima nisu se radile kliničke procjene za ispitanike liječene apiksabanom koji su primili visoke doze andeksaneta alfa, kao ni bolesnika na rivaroksabanu koji su primili nisku dozu andeksaneta alfa.
English: • The other ingredients are Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose,
Croatian: - Drugi sastojci su: tris baza, tris hidroklorid, L-arginin hidroklorid, saharoza, manitol i polisorbat 80.
English: Gently swirl each vial, until all of the powder is completely dissolved.
Croatian: Nježno kružeći oko uzdužne osi bočice miješati sadržaj sve dok se prašak potpuno ne otopi.
English: Apixaban
Croatian: Doziranje
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.
Croatian: U ispitivanju 14-505 (ANNEXA-4), međunarodnom, prospektivnom, otvorenom ispitivanju faze IIIb/IV s jednom skupinom, lijek Ondexxya je primijenjen u 352 bolesnika koji primaju inhibitore FXa a kod kojih se pojavilo veliko akutno krvarenje.
English: Ondexxya 200 mg powder for solution for infusion
Croatian: NAZIV LIJEKA Ondexxya 200 mg prašak za otopinu za infuziju
English: Pyrexia common
Croatian: Pireksija često
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.
Croatian: (95% CI -94,3%; -92,4%) za apiksaban, odnosno -92,5% (95% CI -94,2%; -90,3%) za rivaroksaban.
English: FXa inhibitor last dose
Croatian: Posljednja doza inhibitora FXa
English: Timing of FXa inhibitor last dose before andexanet alfa initiation
Croatian: FXa prije početka primjene andeksaneta alfa
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Kašalj često