natgillin/translations-raw huggingface dataset:
Pharmacotherapeutic group: All other therapeutic products, antidotes. 
Farmakoterapijska skupina: Ostali terapijski pripravci, antidoti.
Your doctor or nurse will give you this medicine by injection or infusion into a vein. 
Liječnik ili medicinska sestra dat će Vam lijek u venu u obliku injekcije ili infuzije.
There is no information on the use of Ondexxya in children and adolescents. 
Nema podataka o primjeni Ondexxye u djece i adolescenata.
In case of mild or moderate infusion reactions, careful observation may be sufficient. 
U slučaju blage ili umjerene infuzijske reakcije, pažljivo nadziranje bolesnika može biti dovoljno.
In an updated interim analysis, data of 352 patients were evaluated. 
U ažuriranoj interim analizi podataka obrađena su 352 bolesnika.
Approximately half of the patients were male, and the mean age was 77.4 years. 
Otprilike polovica bolesnika bili su muškog spola i srednje vrijednosti dobi od 77,4 godine.
These antibodies were generally low titre, and no clinical consequences were observed. 
Njihov je titar općenito bio nizak i nisu primijećene nikakve kliničke posljedice.
Use aseptic technique during the reconstitution procedure. 
Koristite aseptičnu tehniku tijekom postupka rekonstiitucije.
Detailed instructions for your doctor or nurse on how to give Ondexxya are given at the end of this package leaflet (see ‘Handling instructions'). 
Detaljne upute za liječnika ili medicinsku sestru kako primjenjivati Ondexxyu nalaze se na kraju ove upute o lijeku (pogledati „Upute za rukovanje“).
Each vial is reconstituted according to the following instructions: 
Svaka se bočica rekonstituira prema sljedećim uputama:
8 mg/min for 120 minutes (960 mg) 
8 mg/min tijekom 120 minuta (960 mg)
The updated interim analysis demonstrated that the change in anti-FXa activity (surrogate) was not predictive for achievement of hemostatic efficacy in the overall patient population. 
Ažurirana interim analiza pokazala je da promjena u aktivnosti anti-FXa (surogata) nije bila prediktivna za postizanje hemostatske djelotvornosti u sveukupnoj populaciji bolesnika.
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. 
Kliničko značenje ove interakcije u smislu održavanja stvaranja trombina i mogućeg protrombotičkog učinka nije u potpunosti razjašnjeno.
Elderly patients (aged 65 years and over): No dose adjustment is required in elderly patients (see section 5.2). 
Bolesnici starije životne dobi (65 godina ili stariji): Prilagođavanje doze u bolesnika starije životne dobi nije potrebno (vidjeti dio 5.2).
Store in a refrigerator (2°C to 8°C). 
Čuvati u hladnjaku (2 °C - 8 °C).
Duration of this effect in bleeding patients is not known. 
Trajanje ovog učinka u bolesnika koji krvare nije poznato.
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. 
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i ispitivanja toksičnosti ponovljenih doza do dva tjedna, provedenih na štakorima i majmunima.
• Calculated number of vials (see section 4.2). 
• Izračunati broj potrebnih bočica (vidjeti dio 4.2).
Each pack contains four vials. 
Jedno pakiranje sadrži četiri bočice.
The study should be based on an agreed protocol. 
Ispitivanje se mora temeljiti na odobrenom planu ispitivanja.
Pharmacokinetics in special populations 
Farmakokinetika u posebnim populacijama bolesnika
Portola Netherlands B.V. Prins Bernhardplein 200 1097 JB Amsterdam Netherlands 
Prins Bernhardplein 200 1097 JB Amsterdam Nizozemska
Antithrombotic therapy can be re-initiated as soon as medically indicated following treatment if the patient is clinically stable and adequate haemostasis has been achieved. 
Antitrombotička terapija može se ponovno započeti čim je to medicinski indicirano nakon liječenja, a ako je bolesnik klinički stabilan i postignuta je odgovarajuća hemostaza.
Paediatric population: The safety and efficacy of andexanet alfa in children and adolescents have not been established. 
Pedijatrijska populacija: Sigurnost i djelotvornost andeksaneta alfa u djece i adolescenata nisu ustanovljene.
The adverse reactions are classified by system organ class (SOC) and frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); or not known (cannot be estimated from available data). 
Nuspojave su klasificirane prema organskim sustavima i učestalosti pojavljivanja na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
Transient elevations of D-dimer and F1+2 fragments very common 
Pretrage Prolazni porast D-dimera i F1+2 fragmenata vrlo često
The reconstituted solution is a clear, colourless, or slightly yellow solution. 
Rekonstituirana otopina je bistra, bezbojna ili žućkasta otopina.
Initial intravenous bolus 
Početni intravenski bolus
Plasma TFPI activity has been shown to be inhibited for 10 to 20 hours following andexanet alfa administration. 
Pokazalo se da je aktivnost TFPI-ja u plazmi bila inhibirana 10 do 20 sati nakon primjene andeksaneta alfa.
Anti-FXa activity correlates poorly to clinical efficacy and safety, making it unsuitable for dosing guidance (see section 4.4 and 5.1) 
Anti-FXa aktivnost slabo korelira s kliničkom djelotvornosti i sigurnosti, što je čini neprikladnom da bude vodič pri doziranju (vidjeti dijelove 4.4 i 5.1).
Medical judgement should balance the benefits of anticoagulation with the risks of re-bleeding (see section 4.4). 
Medicinska procjena treba odvagnuti koristi primjene antikoagulacije i rizika od ponovnog krvarenja (vidjeti dio 4.4).
Dosage recommendation is based upon data-modelling in healthy volunteers. 
Preporuke za doziranje temelje se na podatkovim modelima dobivenima u zdravih dobrovoljaca.
In the ANNEXA-4 study, of the patients in the safety population completing 30-day follow up (N=351), 54 patients (15.4%) died. 
U ispitivanju ANNEXA-4 među populacijom bolesnika u kojoj se ispituje sigurnost primjene lijeka a dovršili su razdoblje 30-dnevnog praćenja (N = 351), 54 bolesnika (15,4%) je umrlo.
PK comparability with andexanet alfa in Ondexxya (Generation 2) has not yet been proven. 
Usporedivost s farmakokinetikom andeksaneta alfa u Ondexxyi (2. generacija) još nije dokazana.
Powder in a 20 mL vial (Type I glass) with a stopper (butyl rubber). 
Prašak u bočici od 20 ml (staklo tipa I) s čepom (butilna guma).
297/352 patients (84.4%) received the low-dose regimen of andexanet, while 55 patients (15.6%) received the high-dose regimen. 
297/352 bolesnika (84,4%) primalo je andeksanet režimom niskih doza, dok ga je 55 bolesnika (15,6%) primalo režimom visokih doza.
A total of 33.3% of patients with thromboembolic events (12/36) experienced the thromboembolic event during the first three days. 
Ukupno 33,3% bolesnika s tromboembolijskim događajem (12/36) imalo je tromboembolijski događaj tijekom prva tri dana.
Continuous intravenous infusion 
Kontinuirana intravenska infuzija
All used syringes, needles, and vials, including any unused portion of reconstituted solution, should be disposed of in accordance with local requirements. 
Sve upotrijebljene štrcaljke, igle i bočice, uključujući neiskorišteni dio rekonstituirane otopine potrebno je zbrinuti u skladu s nacionalnim propisima.
Restoration of thrombin generation 
Oporavak stvaranja trombina
These markers were not measured in patients enrolled in the ANNEXA-4 study, but thromboembolic events have been observed (see section 5.1). 
Ovi biljezi nisu mjereni u bolesnika uključenih u ispitivanje ANNEXA-4, ali su primijećeni tromboembolijski događaji (vidjeti dio 5.1).
This medicine is unlikely to affect your ability to drive and use machines. 
Nije vjerojatno da će ovaj lijek utjecati na sposobnost upravljanja vozilima i strojevima.
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). 
Na temelju onoga što se zna o dispozicijskoj kinetici nativnog FXa, andeksanet alfa se vjerojatno brzo cijepa u plazmi pomoću endogenih proteaza, u skladu s njegovim relativno kratkim efektivnim poluvijekom (jedan sat).
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. 
U ispitivanju koje je uspoređivalo farmakokinetiku andeksaneta alfa u starijih (65-69 godina) i mlađih (26-42 godina) zdravih ispitanika koji su primili apiksaban, farmakokinetika andeksaneta alfa u starijih ispitanika nije bila statistički drugačija od one u mlađih ispitanika.
Last dose 
Posljednja doza
Therefore, treatment monitoring should be based mainly on clinical parameters indicative of appropriate response (i.e., achievement of haemostasis), lack of efficacy (i.e., re-bleeding), and adverse events (i.e., thromboembolic events). 
Stoga se praćenje terapije mora prvenstveno temeljiti na kliničkim parametrima koji su pokazatelji odgovarajućeg odgovora (tj. postizanje hemostaze), nedostatku djelotvornosti (tj. ponovljenom krvarenju) i štetnim događajima (tj. tromboembolijskim događajima).
Thrombotic events have been reported following treatment with andexanet alfa (see sections 4.8 and 5.1). 
Zabilježeni su trombotički događaji nakon liječenja andeksanetom alfa (vidjeti dijelove 4.8 i 5.1).
Monitoring for signs and symptoms of thrombosis is, therefore, strongly recommended. 
Stoga se strogo preporučuje praćenje pojave znakova i simptoma tromboze.
• Alcohol swabs. 
• Alkoholni tupferi.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). 
Ispitivanja na životinjama su nedostatna za donošenje zaključka o reproduktivnoj toksičnosti (vidjeti dio 5.3).
Other medicines and Ondexxya 
Drugi lijekovi i Ondexxya
The time courses of anti-FXa activity before and after andexanet alfa administration are shown in Figure 1. 
Vremenski tijek anti-FXa aktivnosti prije i nakon primjene andeksaneta alfa prikazan je na slici 1.
There were no blood clots in these healthy people. 
U tih zdravih osoba nisu se stvarali krvni ugrušci.
To date, the occurrence of positive, non-neutralizing antibodies to andexanet alfa following treatment in patients in the ANNEXA-4 study (8.5% or 20/236 patients) has been similar to that observed in healthy subjects. 
Do danas, pojava pozitivnih neneutralizirajućih antitijela na andeksanet alfa nakon liječenja u bolesnika u ispitivanju ANNEXA-4 (8,5% ili 20/236 bolesnika) bila je slična onoj zapaženoj u zdravih ispitanika.
Table 1: Dosing regimens 
Tablica 1: Režim doziranja
Of the 209 patients who were re-anticoagulated prior to a thrombotic event, 10 (4.8%) patients experienced a thromboembolic event. 
Od 209 bolesnika kojima je ponovno uvedena antikoagulantna terapija prije trombotičkog događaja, 10 (4,8%) bolesnika imalo je tromboembolijski događaj.
At the time of the event 10/36 (27.8%) patients were on antithrombotic therapy. 
U vrijeme nastupa događaja 10/36 (27,8%) bolesnika primalo je antitrombotičku terapiju.
Reversing the effect of a factor Xa inhibitor with Ondexxya may increase the risk of blood clots. 
Poništavanje djelovanja inhibitora faktora Xa primjenom Ondexxye može povećati rizik za nastanak krvnih ugrušaka.
DO NOT SHAKE the vials, as this can lead to foaming. 
NEMOJTE MUĆKATI bočicu jer to može dovesti do nastanka pjene.
Although determination of anti-FXa-activity in emergency situations is increasingly recommended, no recommendation for adapted andexanet alfa dosage is available. 
Iako se u hitnim slučajevima sve više preporučuje utvrđivanje anti-FXa aktivnosti, nema dostupnih preporuka za prilagođavanje doze andeksaneta alfa.
For moderate symptoms, consideration may be given to a brief interruption or slowing of the infusion with resumption of the infusion after symptoms subside. 
Kod umjerenih simptoma može se uzeti u obzir kratkotrajni prekid ili usporavanje brzine infuzije, te nastavak infuzije nakon što se simptomi povuku.
Ondexxya is supplied in glass vials as a white to off-white powder for solution for infusion, which is reconstituted (dissolved) before use. 
Ondexxya se isporučuje u staklenim bočicama kao bijeli do gotovo bijeli prašak za otopinu za infuziju, koji se rekonstituira (otapa) prije uporabe.
Andexanet alfa has no or negligible influence on the ability to drive and use machines. 
Andeksanet alfa ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Chemical and physical in-use stability have been demonstrated for 16 hours at 2°C to 8°C in the primary packaging vial. 
Kemijska i fizikalna stabilnost rekonstituiranog lijeka utvrđena je za razdoblje od 16 sati pri temperaturi od 2 °C do 8 °C u bočici primarnog pakiranja.
* Andexanet alfa is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. 
*Andeksanet alfa proizvodi se tehnologijom rekombinantne DNK u stanicama jajnika kineskog hrčka
The maximal reversal of anti-FXa activity was achieved within two minutes of completing the bolus administration. 
Maksimalna reverzija anti-FXa aktivnosti postignuta je unutar dvije minute od završetka primjene bolusa.
Breast-feeding should be discontinued during treatment with andexanet alfa. 
Dojenje treba prekinuti za vrijeme liječenja andeksanetom alfa.
Andexanet alfa is a recombinant form of human FXa protein that has been modified to lack FXa enzymatic activity. 
Andeksanet alfa je rekombinantni oblik ljudskog proteina FXa koji je modificiran tako da mu nedostaje enzimatska aktivnost.
In ANNEXA-4, intracranial haemorrhage (ICH) patients (GCS > 7 and haematoma volume < 60 mL) have been included. 
U ispitivanje ANNEXA-4 uključeni su bolesnici s intrakranijalnim krvarenjem (GCS > 7 i volumen hematoma < 60 ml).
Andexanet alfa is not suitable for pre-treatment of urgent surgery. 
Andeksanet alfa nije prikladan kao pripremna terapija prije hitnih kirurških zahvata.
Ten of 36 (27.8%) patients had restarted antithrombotic therapy at the time of the event, and all 36 patients had been anticoagulated for a prior history of VTE and/or atrial fibrillation at the time of receiving andexanet alfa (see sections 4.4 and 5.1). 
Deset od 36 bolesnika (27,8 %) ponovno su započeli s primjenom antitrombotičke terapije u vrijeme događaja, i svih 36 bolesnika primali su antikoagulacijsku terapiju zbog ranije venske tromboembolije u anamnezi i/ili fibrilacije atrija u vrijeme kad su primili andeksanet alfa (vidjeti dijelove 4.4 i 5.1).
Andexanet alfa is not recommended during pregnancy or in women of childbearing potential not using contraception. 
Andeksanet alfa se ne preporučuje tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
Reversal of the effects of other FXa inhibitors (e.g., fondaparinux, unfractionated heparin) with andexanet alfa has not been studied in humans. 
Reverzija učinaka drugih inhibitora FXa (npr. fondaparinuksa, nefrakcioniranog heparina) pomoću andeksanata alfa nije ispitana u ljudi.
Reduction in anti-FXa activity correlates with restoration of thrombin generation. 
Smanjenje aktivnosti anti-FXa odgovara oporavku stvaranja trombina.
Hypersensitivity to the active substance or to any other ingredients listed in section 6.1. 
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Clearance (L/hr) for andexanet alfa is 4.4 ± 1.2 L/hr with low renal elimination. 
Klirens (l/h) andeksaneta alfa je 4,4 ± 1,2 l/h uz nisku eliminaciju putem bubrega.
Based on population pharmacokinetics analysis, gender does not have a clinically meaningful effect on the pharmacokinetics of andexanet alfa. 
Na temelju analize populacijske farmakokinetike, spol nema klinički značajnog učinka na farmakokinetiku andeksaneta alfa.
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). 
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja andeksaneta alfa u jednoj ili više podskupina pedijatrijske populacije za liječenje i prevenciju krvarenja povezanog s inhibicijom FXa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Feeling hot very common 
Osjećaj vrućine vrlo često
Ondexxya is not recommended during pregnancy or if you have the potential to become pregnant and are not using birth control. 
Primjena Ondexxye se ne preporučuje tijekom trudnoće ili ako postoji mogućnost da zatrudnite a ne koristite kontracepciju.
What you need to know before you receive Ondexxya 3. 
Što morate znati prije nego primite Ondexxyu
The interaction between andexanet alfa and TFPI has not been fully characterized. 
Interakcija andeksaneta alfa i TFPI-ja nije još u potpunosti razjašnjena.
Biliary and/or faeces elimination of protein therapeutics is not a known route of protein elimination. 
Eliminacija proteinskih lijekova putem žuči i/ili stolice nije poznata kao put eliminacije proteina.
Dry mouth common 
Suha usta često
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. 
Vaš liječnik može odlučiti dati Vam Ondexxyu radi brzog poništavanja učinka lijeka protiv zgrušavanja krvi u slučaju po život opasnog ili nekontroliranog krvarenja.
Change in anti-FXa activity (ng/mL) in healthy subjects anticoagulated with apixaban (A) and rivaroxaban (B) 
Promjena anti-FXa aktivnosti (ng/ml) u zdravih ispitanika koji su kao antikoagulans primili apiksaban (A) i rivaroksaban (B)
Use for edoxabanor enoxaparin-reversal is not recommended due to lack of data. 
Primjena za reverziju učinka edoksabana ili enoksaparina se ne preporučuje zbog nedostatka podataka.
What Ondexxya looks like and contents of the pack 
Kako Ondexxya izgleda i sadržaj pakiranja
Treatment-emergent, non-neutralizing antibodies to andexanet alfa were detected in approximately 10% (35/345). 
Neneutralizirajuća antitijela na andeksanet alfa nastala tijekom primjene utvrđena su u otprilike 10% ispitanika (35/345).
The antiFXa activity thresholds for normalization of thrombin generation (defined by mean ETP and standard deviations) were estimated to be 44.2 ng/mL (within one standard deviation of normal ETP) based on pooled data from Studies 14-503 and 14-504, as indicated in the figure. 
Prag anti-FXa aktivnosti za normalizaciju stvaranja trombina (određen srednjom vrijednosti ETP-a i standardnim devijacijama) procjenjuje se da iznosi 44,2 ng/ml (unutar jedne standardne devijacije normalnog ETP-a) a na temelju objedinjenih podataka iz ispitivanja 14-503 i 14-504, kako je prikazano na slici.
Pro-coagulant factor treatments (e.g., 3- or 4-factor prothrombin complex concentrate (PCC)/activated PCC, recombinant factor VIIa, fresh frozen plasma) and whole blood should be avoided unless absolutely required, due to lack of data in combination with these treatments. 
Liječenje prokoagulantnim faktorima (npr. koncentratom protrombinskog kompleksa (PCC) koji sadrži 3 ili 4 faktora / aktiviranim PCC-om, rekombinantnim faktorom VIIa, svježom smrznutom plazmom) i punu krv potrebno je izbjegavati osim ako to nije apsolutno neophodno, zbog nedostatka podataka o liječenju u kombinaciji s takvom terapijom.
Total number of 200 mg vials needed 
Ukupni broj potrebnih bočica od 200 mg
The safety of andexanet alfa has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood within seven days prior to the bleeding event, as they were excluded from clinical trials. 
Sigurnost andeksaneta alfa nije procjenjivana u bolesnika koji su primili koncentrate protrombinskog kompleksa, rekombinantni faktor VIIa ili punu krv unutar sedam dana prije krvarenja, jer su ti bolesnici bili isključeni iz kliničkih ispitivanja.
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. 
Glavobolja, kašalj ili nedostatak zraka (česte nuspojave koje se mogu javiti u do 1 na 10 osoba) koje su se javljale nekoliko minuta do nekoliko sati nakon infuzije.
What Ondexxya is and what it is used for 2. 
Što je Ondexxya i za što se koristi 2.
Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake "EXP".
> 5 mg/ Unknown 
> 5 mg/ nepoznato visoka doza
Data from bleeding patients are limited. 
Podaci dobiveni u bolesnika koji krvare ograničeni su.
System organ class/ Preferred term 
Klasifikacija organskih sustava / Preporučeni pojam
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”). 
Oporavak stvaranja trombina nakon primjene ovisio je o dozi i režimu doziranja i nije korelirao s antiFXa aktivnosti nakon otprilike četiri sata (vidjeti u nastavku, „oporavak stvaranja trombina“).
In addition, independent pro-thrombotic effect of andexanet alfa cannot be ruled out. 
Osim toga, samostalni protrombotički učinak samog andeksaneta alfa ne može se isključiti.
Andexanet alfa will not reverse the effects of non-FXa inhibitors (see section 5.1). 
Andeksanet alfa neće poništiti učinak inhibitora koji ne djeluju na FXa (vidjeti dio 5.1).
Studies to evaluate the mutagenic and carcinogenic potential of andexanet alfa have not been performed. 
Nisu provedena ispitivanja za procjenu mutagenog i kancerogenog potencijala andeksaneta alfa.
For subjects on rivaroxaban, high-dose andexanet alfa (bolus plus infusion) resulted in increased thrombin generation above two standard deviations. 
Za ispitanike koji su primali rivaroksaban, primjena visoke doza andeksaneta alfa (bolus i infuzija) dovela je do povećanog stvaranja trombina iznad dvije standardne devijacije.
Reconstituted medicinal product 
Rekonstituirani lijek
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 . 
Dvije koprimarne mjere ishoda bile su: a) postotna promjena anti-FXa aktivnosti od početnih vrijednosti do najniže vrijednosti za period između pet minuta nakon završetka bolusa i vremena završetka infuzije; i b) stopa dobre ili izvrsne (u usporedbi sa slabom ili nikakvom) hemostatske djelotvornosti unutar 12 sati nakon završetka infuzije, kako je to ocijenio neovisni odbor za prosudbu mjera ishoda.
For reconstituted solutions, chemical and physical in-use stability have been demonstrated for at least eight hours at 25°C. 
Kemijska i fizikalna stabilnost rekonstituirane otopine u primjeni utvrđena je za razdoblje od najmanje 8 sati pri temperaturi od 25 °C.
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. 
8. Za najučinkovitiji postupak rekonstitucije potrebne doze i minimiziranja greški, u svaku bočicu uštrcajte 20 ml otopine za injekciju prije prelaska na sljedeći korak.
Clinical efficacy is based upon reversal of anti-FXa-activity in healthy volunteers dosed with apixaban or rivaroxaban. 
Klinička djelotvornost temelji se na reverziji anti-FXa aktivnosti u zdravih dobrovoljaca koji su primili apiksaban ili rivaroksaban.