FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4 provides the list of adverse reactions from clinical studies of healthy subjects treated with andexanet alfa.
Estonian: Tabelis 4 on esitatud kõrvaltoimete loend, mis pärineb kliinilistest uuringutest tervete uuritavatega, keda raviti alfaandeksaneediga.
English: 345 andexanet alfa-treated healthy subjects were tested for antibodies cross reacting with andexanet alfa and antibodies to factor X and FXa.
Estonian: 345 tervet uuritavat, keda raviti alfaandeksaneediga, hinnati alfaandeksaneediga ristreageerivate antikehade ning X faktori ja FXa vastaste antikehade suhtes.
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.
Estonian: Pärast alfaandeksaneedi manustamist täheldati koagulatsioonimarkerite (F1+2, TAT ja D-dimeerid) hulga annussõltuvat suurenemist, kuid uuringusse ANNEXA-4 kaasatud patsientidel neid markereid ei hinnatud ja nende asjakohasus verejooksuga patsientidel ei ole teada.
English: Powder for solution for infusion White to off-white lyophilized powder
Estonian: Infusioonilahuse pulber Valge kuni valkjas lüofiliseeritud pulber
English: • if you are allergic to andexanet alfa or any of the other ingredients of this medicine (listed in section 6).
Estonian: - kui olete alfaandeksaneedi või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline; - kui olete hamstri valkude suhtes allergiline.
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.
Estonian: Alfaandeksaneedi toime hindamisel saab lähtuda nii farmakodünaamilistest markeritest, sh FXa-vastasest toimest ja saadaolevate FXa inhibiitorite vabast fraktsioonist, kui ka trombiini moodustumise taastumisest.
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.
Estonian: 30 päeva järelkontrolli kestel oli suremuse määr intrakraniaalse verejooksuga patsientidel 16,2% (37/229), seederakti verejooksuga patsientidel 12,8% (12/94) ja muud tüüpi verejooksuga patsientidel 17,9% (5/28).
English: Do not breast-feed your child while you are taking this medicine.
Estonian: Selle ravimi võtmise ajal ei tohi rinnaga toita.
English: Of the 209 patients who were re-anticoagulated prior to a thrombotic event, 10 (4.8%) patients experienced a thromboembolic event.
Estonian: 209-st patsiendist, kes said enne trombemboolilist tüsistust uuesti antikoagulantravi, tekkis trombembooliline tüsistus kümnel (4,8%).
English: Annex IV Conclusions on the granting of the conditional marketing authorisation presented by the European Medicines Agency
Estonian: IV LISA EUROOPA RAVIMIAMETI ESITATUD JÄRELDUSED TINGIMUSLIKU MÜÜGILOA ANDMISE KOHTA
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.
Estonian: Annus põhineb nii konkreetsel hüübimisvastasel ravimil, mida te kasutate, kui ka annusel ja hüübimisvastase ravimi viimase annuse võtmisest möödunud ajal.
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.
Estonian: Olemasolevate farmakokineetika andmete põhjal on alfaandeksaneedi neerudekaudne kliirens vähene või puudub, mistõttu ei ole neerukahjustusega patsientidel annuse kohandamine vajalik.
English: Fertility There are no data on the effects of andexanet alfa on human fertility.
Estonian: Fertiilsus Alfaandeksaneedi toime kohta inimeste fertiilsusele andmed puuduvad.
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.
Estonian: FXa-vastane toime saavutas platseebo taseme ning tugevnes üle selle ligikaudu kaks tundi pärast boolussüste või infusiooni lõpetamist, olenevalt annusest.
English: Andexanet alfa binds direct FXa inhibitors with high affinity, making them unavailable to exert their anticoagulant effects.
Estonian: Alfaandeksaneet seondub suure afiinsusega otseste FXa inhibiitoritega, takistades seega nende antikoaguleeriva toime avaldumist.
English: • Same number of 20 mL (or larger) solvent syringes equipped with a 20 gauge (or larger) needle.
Estonian: • Sama arv 20 ml (või suuremaid) süstlaid lahustiga, millele on kinnitatud vähemalt 20 G nõel.
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.
Estonian: Ehkki boolussüste lahuse ja infusioonilahuse kombineerimine ühte intravenoosse lahuse kotti on lubatud, on õiges manustamiskiiruses veendumiseks soovitatav panna boolussüste lahus ja infusioonilahus kahte eraldi kotti.
English: Hyperhidrosis common
Estonian: Hüperhidroos sage
English: Last dose
Estonian: Viimane annus
English: Restricted to hospital use only.
Estonian: Ainult haiglas kasutamiseks.
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.
Estonian: Täielikus 30-päevases järelkontrollis osalenud 36 patsiendil 352-st (10,3%) tekkisid tromboosid/embooliad, sh venoosne trombemboolia, müokardiinfarkt ja insult.
English: There are no data from the use of andexanet alfa in pregnant women.
Estonian: Alfaandeksaneedi kasutamise kohta rasedatel andmed puuduvad.
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.
Estonian: Vajaliku annuse efektiivseima manustamiskõlblikuks muutmise ja vigade minimeerimise tagamiseks süstige igasse vajaminevasse viaali kõigepealt 20 ml süstevett ning alles seejärel jätkake järgmise etapiga.
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%).
Estonian: Uuringus ANNEXA-4 tekkis 36 patsiendil (10,3%) kokku 43 trombemboolilist tüsistust: tserebrovaskulaarne häire (15/43; 35,7%), süvaveeni tromboos (14/43; 33,3%), äge müokardiinfarkt (8/43; 19,0%), kopsuarteri trombemboolia (5/43; 11,9%) ja transitoorne isheemiline atakk (1/43; 2,4%).
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).
Estonian: Kardiovaskulaarsed surma põhjused (n = 27) olid muu hulgas hemorraagiline insult (n = 6), isheemiline insult (n = 5), kardiaalne äkksurm (sh tunnistajateta juhud) (n = 5), südame mehaaniline häire / pumbafunktsiooni puudulikkus (n = 4), müokardiinfarkt (n = 2), verejooks, v.a hemorraagiline insult (n = 1), ja muud kardiovaskulaarsed põhjused (n = 4).
English: Studies to evaluate the mutagenic and carcinogenic potential of andexanet alfa have not been performed.
Estonian: Alfaandeksaneedi mutageensuse ja kartsinogeensuse hindamiseks ei ole uuringuid tehtud.
English: FXa inhibitors did not affect andexanet alfa pharmacokinetics at therapeutic levels.
Estonian: FXa inhibiitorid ei mõjutanud ravikontsentratsioonides alfaandeksaneedi farmakokineetikat.
English: The safety and efficacy have not been studied in patients with hepatic impairment (see section 5.2).
Estonian: Maksakahjustusega patsientidel ei ole ravimi ohutust ja efektiivsust uuritud (vt lõik 5.2).
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.
Estonian: Vabade FXa inhibiitorite kontsentratsiooni muutus nadiiris võrreldes algnäitajatega Apiksabaani ja rivaroksabaani keskmised seondumata kontsentratsioonid pärast alfaandeksaneedi boolussüstet olid vastavalt < 3,5 ng/ml ja 4 ng/ml ning need püsisid kogu püsiinfusiooni kestel.
English: Name and address of the manufacturer of the biological active substance Lonza Biologics Porrino, S.L.
Estonian: Lonza Biologics Porrino, S.L.
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).
Estonian: Lisamahu tõttu tuleb suured boolus- ja infusiooniannused jaotada mitme süstla vahel (mõlemale, nii boolussüstele kui ka infusioonile tuleb võtta kaks süstalt).
English: Administration using an intravenous bag 1.
Estonian: Intravenoosse lahuse infusioon 1.
English: For subjects on rivaroxaban, high-dose andexanet alfa (bolus plus infusion) resulted in increased thrombin generation above two standard deviations.
Estonian: Rivaroksabaaniga ravi saanud uuringus osalejatel andis alfaandeksaneedi suure annuse (boolussüste pluss infusioon) manustamine tulemuseks trombiini moodustumise suurenemise üle kahe standardhälbe.
English: After reconstitution, each mL of solution contains 10 mg of andexanet alfa.
Estonian: Pärast manustamiskõlblikuks muutmist sisaldab üks ml lahust 10 mg alfaandeksaneeti.
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%).
Estonian: Euroopa Liidus uuringusse kaasatud patsiendid olid Põhja-Ameerikas uuringusse kaasatud patsientidega võrreldes oluliselt vanemad (79,0-aastased vs.76,3-aastased), neil esines sagedamini surma põhjustanud intrakraniaalset verejooksu (72,9% vs.59,0%) ning neil esinenud intrakraniaalsed verejooksud olid sagedamini intraparenhümaalsed (54,9% vs. 34,4%).
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.
Estonian: Vajutage kolbi aeglaselt allapoole ja süstige 20 ml süstevett viaali; vahu tekke minimeerimiseks suunake veejuga vastu viaali seina.
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).
Estonian: Kliinilistes uuringutes on ohutust hinnatud nii 247 tervel uuritaval, kellele manustati FXa inhibiitorit, kui ka IIIb/IV faasi uuringus (ANNEXA-4) osalenud 352 patsiendil, kellel oli raske verejooks ja keda raviti FXa inhibiitoriga (peamiselt apiksabaani ja rivaroksabaaniga).
English: 800 mg at a target rate of 30 mg/min
Estonian: 800 mg optimaalse manustamiskiirusega 30 mg/min
English: Powder in a 20 mL vial (Type I glass) with a stopper (butyl rubber).
Estonian: Pulber punnkorgiga (butüülkummist) suletud 20 ml viaalis (I tüüpi klaasist).
English: 400 mg at a target rate of 30 mg/min
Estonian: 400 mg optimaalse manustamiskiirusega 30 mg/min
English: Each vial contains 200 mg of andexanet alfa*.
Estonian: Üks viaal sisaldab 200 mg alfaandeksaneeti*.
English: Based on the existing data on clearance, no dose adjustment is recommended.
Estonian: Olemasolevate kliirensiandmete põhjal ei ole annuse kohandamine soovitatav.
English: How Ondexxya is used
Estonian: Kuidas Ondexxyat kasutada
English: Diphenhydramine may be administered.
Estonian: Võib manustada difenhüdramiini.
English: What Ondexxya is and what it is used for
Estonian: Mis ravim on Ondexxya ja milleks seda kasutatakse
English: The reconstituted solution should be inspected for particulate matter and/or discolouration prior to administration.
Estonian: Manustamiskõlblikuks muudetud lahust tuleb enne manustamist kontrollida tahkete osakeste ja/või värvimuutuse osas.
English: Initial intravenous bolus
Estonian: Esialgne intravenoosne boolussüste
English: This medicine has been designed to reverse the effects of factor Xa inhibitor medicines only.
Estonian: See ravim on ette nähtud ainult Xa faktori inhibiitorite toime neutraliseerimiseks.
English: At the time of the event 10/36 (27.8%) patients were on antithrombotic therapy.
Estonian: Kümme patsienti 36-st (27,8%) said tüsistuse tekkimise ajal antitrombootilist ravi.
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).
Estonian: Biomarkeri (FXa-vastase toime) ja hemostaatilise efektiivsuse vahelise korrelatsiooni põhjendamiseks ning tromboosi ja trombemboolsete tüsistuste tekkeriski selgitamiseks peab müügiloa hoidja esitama globaalse randomiseeritud, kontrollrühmaga kliinilise uuringu andmed, kus võrreldakse andeksaneedi ja standardravi toimet intrakraniaalse verejooksuga patsientidel, kes võtavad apiksabaani, rivaroksabaani või edoksabaani (uuring 18-513).
English: It reverses the effects of certain anticoagulants called factor Xa inhibitors (apixaban or rivaroxaban).
Estonian: See neutraliseerib teatavate hüübimisvastaste ainete (Xa faktori inhibiitorid apiksabaan või rivaroksabaan) toime.
English: List of possible side effects
Estonian: Võimalike kõrvaltoimete loend
English: Attach ancillary equipment (i.e., extension tubing, air filters, IV pump) in preparation for administration.
Estonian: Manustamiseks ettevalmistamiseks kinnitage lisavarustus (st pikendusvoolikud, õhufiltrid, infusioonipump).
English: Reversing the effect of a factor Xa inhibitor with Ondexxya may increase the risk of blood clots.
Estonian: Xa faktori toime neutraliseerimine Ondexxya abil võib suurendada verehüüvete (trombide) tekkeriski.
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).
Estonian: Trombembooliliste tüsistuste esinemissagedus oli > 75-aastaste (11,0%; 24/219) ja ≤ 75-aastaste (9,1%; 12/132) võrdluses üldjuhul sarnane.
English: Total number of 200 mg vials needed
Estonian: Nõutav 200 mg viaalide koguarv
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.
Estonian: Trombiini moodustumise taastumine normaalvahemiku piiresse (määratletud kui üks standardhälve ravieelsetest näitajatest) kahe minuti jooksul ja selle püsimine 20 tunni jooksul saavutati apiksabaaniga ravi saanud uuringus osalejatel ainuüksi alfaandeksaneedi väikese annuse boolussüstega ning alfaandeksaneedi väikese annuse boolussüste ja infusiooni kombinatsiooniga.
English: Administration using a syringe pump 1.
Estonian: Perfuusoriga manustamine 1.
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.
Estonian: Tervetel vabatahtlikel täheldati pärast alfaandeksaneedi manustamist koagulatsioonimarkerite (F1+2, TAT ja D-dimeer) hulga annusest olenevat suurenemist, kuid trombemboolia juhtudest ei teatatud.
English: Hepatic impairment: Based on the existing data on clearance of andexanet alfa, no dose adjustment is recommended.
Estonian: Maksakahjustus: alfaandeksaneedi olemasolevate kliirensiandmete põhjal ei ole annuse kohandamine soovitatav.
English: Ondexxya 200 mg powder for solution for infusion
Estonian: Ondexxya 200 mg infusioonilahuse pulber
English: Andexanet alfa is a recombinant form of human FXa protein that has been modified to lack FXa enzymatic activity.
Estonian: Alfaandeksaneet on inimese FXa valgu rekombinantne ravimvorm, mille FXa ensümaatiline toime on modifitseerimise käigus kõrvaldatud.
English: • The other ingredients are Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose,
Estonian: - Teised koostisosad on Trometamool, Tris-vesinikkloriid, arginiinvesinikkloriid, sahharoos,
English: Clearance (L/hr) for andexanet alfa is 4.4 ± 1.2 L/hr with low renal elimination.
Estonian: Aeglase neerudekaudse eritumise korral on alfaandeksaneedi kliirens (l/h) 4,4 ± 1,2 l/h.
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.
Estonian: Mediaanne muutus FXa-vastases toimes ravi algusest kuni nadiirini oli apiksabaani korral -93,4% (95% CI -94,3%; 92,4%) ja rivaroksabaani korral -92,5% (95% CI -94,2%; -90,3%).
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.
Estonian: Xa faktori (FXa) otsese inhibiitoriga (apiksabaan või rivaroksabaan) ravi saavad täiskasvanud patsiendid, kui eluohtliku või ravile allumatu veritsuse tõttu on vaja nende ravimite antikoaguleeriv toime neutraliseerida.
English: Andexanet alfa reverses the anticoagulant effect of direct factor Xa (FXa) inhibitor products (apixaban, rivaroxaban) only.
Estonian: Alfaandeksaneet neutraliseerib ainult Xa faktorit (FXa) otseselt inhibeerivate ravimite (apiksabaan, rivaroksabaan) toime.
English: The clinical relevance of this interaction in terms of maintenance of thrombin generation and the potential for a prothrombotic effect has not been fully elucidated.
Estonian: Trombiini jätkuva moodustumise ja protrombootilise toime potentsiaali osas ei ole selle koostoime kliiniline olulisus lõpuni välja selgitatud.
English: These levels of unbound FXa inhibitor provide little or no anticoagulant effect.
Estonian: Sellistes kogustes on seondumata FXa inhibiitorite antikoaguleeriv toime vähene või puudub üldse.
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.
Estonian: Nii uuringu 14-503 (apiksabaan) kui ka uuringu 14-504 (rivaroksabaan) esmane tulemusnäitaja oli FXa-vastase toime protsentuaalne muutus alates ravieelsetest näitajatest kuni infusioonijärgse nadiirini.
English: Based on population pharmacokinetics analysis, gender does not have a clinically meaningful effect on the pharmacokinetics of andexanet alfa.
Estonian: Populatsiooni farmakokineetika andmeil ei avalda sugu kliiniliselt olulist toimet alfaandeksaneedi farmakokineetikale.
English: Plasma TFPI activity has been shown to be inhibited for 10 to 20 hours following andexanet alfa administration.
Estonian: Alfaandeksaneedi manustamise järgselt kestis TFPI aktiivsuse inhibeerimine plasmas 10...20 tundi.
English: • The active substance is andexanet alfa.
Estonian: - Toimeaine on alfaandeksaneet.
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.
Estonian: 30 päeva järelkontrolli kestel oli suremuse määr > 75-aastastel patsientidel 20,1% (44/219) ning ≤ 75-aastastel patsientidel 765% (10/132).
English: Ondexxya 200 mg powder for solution for infusion andexanet alfa
Estonian: Ondexxya 200 mg infusioonilahuse pulber alfaandeksaneet
English: Aseptic technique during the reconstitution procedure should be used.
Estonian: Manustamiskõlblikuks muutmisel tuleb kasutada aseptilist meetodit.
English: There is no clinical experience with overdose of andexanet alfa.
Estonian: Alfaandeksaneedi üleannustamise kliinilised kogemused puuduvad.
English: Attach ancillary equipment (i.e., extension tubing, air filters, syringe driver) in preparation for administration.
Estonian: Manustamiseks ettevalmistamiseks kinnitage lisavarustus (st pikendusvoolikud, õhufiltrid, perfuusor).
English: Each vial contains 200 mg of andexanet alfa.
Estonian: Üks viaal sisaldab 200 mg alfaandeksaneeti.
English: FXa inhibitor last dose
Estonian: FXa inhibiitori viimane annus
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.
Estonian: Uuringus 14-504 rivaroksabaanravi saanud uuritavatel oli FXa-vastase toime protsentuaalne muutus alfaandeksaneedi rühmas -96,72% (± 1,838%) ja platseeborühmas -44,75% (± 11,749%) (p < 0,0001), kusjuures viimane kajastas antikoagulandi loomuomast kliirensit.
English: Administration of andexanet alfa as a bolus followed by continuous infusion resulted in a sustained decrease in anti-FXa activity.
Estonian: Alfaandeksaneedi boolussüste ning sellele järgnenud püsiinfusiooni tulemusel jäi FXa-vastase toime langus kestma.
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.
Estonian: Tervetel uuritavatel tehtud prospektiivsetes randomiseeritud, platseebokontrolliga annuse leidmise uuringutes määrati kindlaks FXa-vastase toime neutraliseerimiseks ning FXa inhibiitorite (apiksabaan või rivaroksabaan) kasutamisel trombiini tootmise taastamiseks nõutav alfaandeksaneedi annus ja manustamisskeem.
English: In ANNEXA-4, intracranial haemorrhage (ICH) patients (GCS > 7 and haematoma volume < 60 mL) have been included.
Estonian: Uuringusse ANNEXA-4 kaasati ka intrakraniaalse verejooksuga (Glasgow kooma skaala (Glasgow Coma Scale, GCS) skoor > 7 ja hematoomi maht < 60 ml) patsiendid.
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.
Estonian: Esialgsete andmete põhjal võib eeldada, et suuremas annuses andeksaneeti saavatel patsientidel, varem väiksemas annuses FXavastast inhibiitorit saanutel ja rivaroksabaaniga ravitud patsientidel on tromboosi tekkerisk suurem.
English: Ondexxya contains the active ingredient andexanet alfa.
Estonian: Ondexxyas sisalduv toimeaine on alfaandeksaneet.
English: Thromboembolic events
Estonian: Trombemboolilised tüsistused
English: Table 4: List of adverse reactions in healthy subjects and bleeding patients System organ class/ Preferred term
Estonian: Tervetel uuritavatel ja verejooksuga patsientidel esinenud kõrvaltoimete loend Organsüsteemi klass / eelistermin
English: No dose-limiting toxicities have been observed during clinical trials.
Estonian: Kliinilistes uuringutes ei ole annust piiravat toksilisust täheldatud.
English: Reconstituted medicinal product
Estonian: Manustamiskõlblikuks muudetud ravimpreparaat
English: Dosage and administration
Estonian: Annus ja manustamine
English: Name and address of the manufacturer responsible for batch release Portola Netherlands B.V.
Estonian: Portola Netherlands B.V.
English: Clinical efficacy is based upon reversal of anti-FXa-activity in healthy volunteers dosed with apixaban or rivaroxaban.
Estonian: Kliiniline efektiivsus tugineb tervete vabatahtlike andmeile, kellel neutraliseeriti apiksabaani või rivaroksabaani manustamise järgselt ravimi FXa-vastane toime.