FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of using Praxbind in patients with known hypersensitivity (e.g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such an emergency treatment.
Slovenian: Tveganje uporabe zdravila Praxbind pri bolnikih z znano preobčutljivostjo (npr. anafilaktoidno reakcijo) za idarucizumab ali katero koli pomožno snov je treba skrbno pretehtati glede na možne koristi tovrstnega nujnega zdravljenja.
English: The median peak dabigatran exposure in the investigated healthy subjects was in the range of a twice daily administration of 150 mg dabigatran etexilate in patients.
Slovenian: Mediana največje izpostavljenosti dabigatranu pri proučevanih zdravih preizkušancih je bila na ravni dvakrat dnevnega dajanja 150 mg dabigatran eteksilata bolnikom.
English: No treatmentrelated effects have been identified in reproductive tissues of either sex during repeat dose intravenous toxicity studies of up to four weeks in the rat and two weeks in monkeys.
Slovenian: Z zdravljenjem povezanih učinkov na reproduktivna tkiva katerega koli spola na osnovi študij intravenske toksičnosti pri ponavljajočih se odmerkih, ki so pri podganah trajale do štiri tedne in pri opicah do dva tedna, niso ugotovili.
English: • coagulation factor concentrates, such as prothrombin complex concentrates (PCCs, e.g. 3 factor and
Slovenian: • koncentrati koagulacijskih faktorjev, kot so koncentrati protrombinskega kompleksa (PCC-ji,
English: Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
Slovenian: Odsotnost antitrombotične terapije bolnika izpostavi tveganju za trombozo, povezano z osnovno boleznijo ali stanjem.
English: Studies to assess the potential reproductive effects of idarucizumab have not been performed.
Slovenian: Študij o možnih učinkih idarucizumaba na sposobnost razmnoževanja niso izvedli.
English: A value in the normal range after administration of idarucizumab indicates that a patient is no longer anticoagulated.
Slovenian: Vrednost v normalnem območju po dajanju idarucizumaba kaže, da bolnik ni več antikoaguliran.
English: No incompatibilities between Praxbind and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.
Slovenian: Inkompatibilnosti med zdravilom Praxbind in infuzijskimi kompleti iz polivinil klorida, polietilena ali poliuretana ali polipropilenskimi brizgami niso opazili.
English: Dosage and adminstration:
Slovenian: Odmerjanje in dajanje:
English: Idarucizumab treatment normalised both thrombin lag time ratio and time to peak ratio to baseline levels as determined 0.5 to 12 hours after the end of the idarucizumab infusion.
Slovenian: Zdravljenje z idarucizumabom je normaliziralo razmerje zakasnitvenega časa trombina in razmerje časa do največjega učinka na izhodiščne vrednosti, kar je bilo določeno 0,5 do 12 ur po koncu infundiranja idarucizumaba.
English: In a subset of patients, recurrence of plasma levels of unbound dabigatran and concomitant elevation of clotting tests was observed, possibly due to re-distribution of dabigatran from the periphery.
Slovenian: V podskupini bolnikov je prišlo do ponovnih plazemskih koncentracij nevezanega dabigatrana in sočasnega zvišanja testov strjevanja krvi, morda zaradi prerazporeditve dabigatrana iz periferije.
English: Therefore, in patients with hereditary fructose intolerance the risk of treatment with Praxbind must be weighed against the potential benefit of such an emergency treatment.
Slovenian: Zato je treba pri bolnikih z dedno intoleranco na fruktozo tveganje zdravljenja z zdravilom Praxbind pretehtati glede na možne koristi takega nujnega zdravljenja.
English: Praxbind solution for injection/infusion is a clear to slightly opalescent, colourless to slightly yellow solution supplied in a glass vial closed with a butyl rubber stopper and an aluminium cap.
Slovenian: Zdravilo Praxbind raztopina za injiciranje/infundiranje je bistra do rahlo opalescentna, brezbarvna do rumenkasta raztopina, na voljo v stekleni viali, zaprti z zamaškom iz butilne gume in aluminijasto zaporko.
English: What Praxbind is and what it is used for
Slovenian: Kaj je zdravilo Praxbind in za kaj ga uporabljamo
English: The idarucizumab formulation did not produce haemolysis of human whole blood in vitro.
Slovenian: Formulacija idarucizumaba v polni človeški krvi in vitro ni povzročila hemolize.
English: OTHER - Printing on inside of lid
Slovenian: DRUGO - Natis znotraj pokrova
English: Praxbind is a reversal agent specific for dabigatran (Pradaxa), a blood thinner medicine that blocks a substance in the body, which is involved in blood clot formation.
Slovenian: Zdravilo Praxbind je protiučinkovina, specifična za dabigatran (zdravilo Pradaxa), zdravilo za redčenje krvi, ki zavira snovi v telesu, ki sodelujejo pri nastajanju krvnih strdkov.
English: No impact on the pharmacokinetics or the reversal effect of idarucizumab or hypersensitivity reactions were observed.
Slovenian: Vpliva na farmakokinetiko ali učinka izničenja idarucizumaba ali preobčutljivostnih reakcij niso opazili.
English: Praxbind must not be mixed with other medicinal products.
Slovenian: Zdravila Praxbind ne smemo mešati z drugimi zdravili.
English: This medicinal product contains 50 mg sodium per dose, equivalent to 2.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 50 mg natrija na odmerek, kar je enakovredno 2,5 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO, in znaša 2 g.
English: No dose adjustment is required in elderly patients aged 65 years and above (see section 5.2).
Slovenian: Bolnikom, starim 65 let in več, odmerka ni treba prilagajati (glejte poglavje 5.2).
English: 6.1 List of excipients sodium acetate trihydrate acetic acid sorbitol polysorbate 20 water for injection
Slovenian: 6.1 Seznam pomožnih snovi natrijev acetat trihidrat ocetna kislina sorbitol polisorbat 20 voda za injekcije
English: Idarucizumab exhibited multiphasic disposition kinetics and limited extravascular distribution.
Slovenian: Idarucizumab ima večfazno dispozicijsko kinetiko in omejeno ekstravaskularno porazdelitev.
English: Until now, no side effects have been indentified.
Slovenian: Do sedaj niso opazili neželenih učinkov.
English: Praxbind contains sodium
Slovenian: Zdravilo Praxbind vsebuje natrij
English: Dabigatran prolongs the clotting time of coagulation markers such as diluted Thrombin Time (dTT), Thrombin Time (TT), activated Partial Thromboplastin Time (aPTT) and Ecarin Clotting Time (ECT), which provide an approximate indication of the anticoagulation intensity.
Slovenian: Dabigatran podaljša čas strjevanja koagulacijskih markerjev, kot so razredčitveni trombinski čas (dTT), trombinski čas (TT-Thrombin Time), aktivirani delni tromboplastinski čas (aPTČ) in ekarinski čas koagulacije (EKT), kar je približen pokazatelj jakosti antikoagulacije.
English: What Praxbind looks like and contents of the pack
Slovenian: Izgled zdravila Praxbind in vsebina pakiranja
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection/infusion contains 50 mg idarucizumab.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En mililiter raztopine za injiciranje/infundiranje vsebuje 50 mg idarucizumaba.
English: No dose adjustment is required in patients with hepatic injury (see section 5.2).
Slovenian: Bolnikom s poškodbo jeter odmerka ni treba prilagajati (glejte poglavje 5.2).
English: There are no data on the effect of Praxbind on fertility (see section 5.3).
Slovenian: Podatkov o vplivu zdravila Praxbind na plodnost ni (glejte poglavje 5.3).
English: It is unknown whether idarucizumab is excreted in human milk.
Slovenian: Ni znano, ali se idarucizumab izloča v materino mleko.
English: An impact of hepatic impairment, assessed by hepatic injury as determined by elevated liver function tests, on the pharmacokinetics of idarucizumab has not been observed.
Slovenian: Ni bilo opaženo, da bi jetrna okvara, ocenjena s poškodbo jeter, kot jo opredeljuje povišan test delovanja jeter, vplivala na farmakokinetiko idarucizumaba.
English: This medicine will only remove dabigatran from your body.
Slovenian: To zdravilo bo iz vaše krvi odstranilo samo dabigatran.
English: PHARMACEUTICAL FORM AND CONTENTS solution for injection/infusion 2 vials of 50 mL each
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje/infundiranje 2 viali po 50 ml
English: Pack size of 2 vials.
Slovenian: Velikost pakiranja sta 2 viali.
English: Patients being treated with dabigatran have underlying disease states that predispose them to thromboembolic events.
Slovenian: Bolniki, zdravljeni z dabigatranom, imajo osnovna bolezenska stanja, ki povečujejo nagnjenost za tromboembolične dogodke.
English: Effect of idarucizumab on the exposure and anticoagulant activity of dabigatran
Slovenian: Učinek idarucizumaba na izpostavljenost in antikoagulacijsko delovanje dabigatrana
English: The pharmacodynamics of idarucizumab after administration of dabigatran etexilate were investigated in 141 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Slovenian: Farmakodinamiko idarucizumaba po dajanju dabigatran eteksilata so proučili pri 141 preizkušancih študij I. faze, pri čemer so predstavljeni podatki reprezentativne podskupine 6 zdravih preizkušancev, starih od 45 do 64 let, ki so prejeli odmerek 5 g v obliki intravenske infuzije.
English: The recommended dose is 5 g (2 vials of 50 mL).
Slovenian: Priporočeni odmerek je 5 g (2 viali po 50 ml).
English: There is no clinical experience with overdoses of Praxbind.
Slovenian: Kliničnih izkušenj s prevelikim odmerjanjem zdravila Praxbind ni.
English: Praxbind causes transient proteinuria as a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously (see section 5.2).
Slovenian: Zdravilo Praxbind povzroča prehodno proteinurijo zaradi fiziološkega odziva na presežek beljakovin v ledvicah po bolusni/kratkotrajni intravenski uporabi idarucizumaba po 5 g (glejte poglavje 5.2).
English: A pre-existing intravenous line may be used for administration of Praxbind.
Slovenian: Za dajanje zdravila Praxbind lahko uporabimo obstoječa intravensko linijo.
English: - The other ingredients are sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20 and water for injection.
Slovenian: - Druge sestavine zdravila so natrijev acetat trihidrat, ocetna kislina, sorbitol, polisorbat 20 in voda za injekcije.
English: Compared to 272 patients without hepatic impairment, the median AUC of idarucizumab was changed by -6%, 37% and 10% in patients with AST/ALT elevations of 1 to <2x ULN (N=34), 2 to <3x ULN (N=3) and >3x ULN (N=21), respectively.
Slovenian: V primerjavi z 272 bolniki brez jetrne okvare se je mediana AUC idarucizumaba spremenila za -6 % pri bolnikih z vrednostmi AST/ALT, povišanimi za od 1- do < 2-kratnika zgornje meje normale (N = 34), za 37 % pri bolnikih z vrednostmi AST/ALT, povišanimi za od 2- do < 3-kratnik zgornje meje normale (N = 3), in za 10 % pri bolnikih z vrednostmi AST/ALT, povišanimi za > 3-kratnik zgornje meje normale (N = 21).
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Formalnih študij medsebojnega delovanja zdravila Praxbind z drugimi zdravili niso izvedli.
English: Pradaxa (dabigatran etexilate) treatment can be re-initiated 24 hours after administration of Praxbind, if the patient is clinically stable and adequate haemostasis has been achieved.
Slovenian: Zdravljenje z zdravilom Pradaxa (dabigatran eteksilat) lahko ponovno uvedemo 24 ur po dajanju zdravila Praxbind, če je bolnik klinično stabilen in je bila dosežena ustrezna hemostaza.
English: Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Parenteralna zdravila, kot je zdravilo Praxbind, je treba pred dajanjem pregledati s prostim očesom glede prisotnosti trdnih delcev in obarvanosti.
English: Preclinical investigations with idarucizumab have shown no interactions with
Slovenian: Predklinične raziskave z idarucizumabom niso pokazale medsebojnega delovanja z:
English: The solution should not be exposed to light for more than 6 hours (in unopened vial and/or inuse).
Slovenian: Raztopina (v neodprti viali in/ali med uporabo) ne sme biti izpostavljen svetlobi več kot 6 ur.
English: In patients with hereditary fructose intolerance there is a risk for serious adverse reactions, which must be weighed against the benefit of an emergency treatment with Praxbind.
Slovenian: Zato obstaja pri bolnikih z dedno intoleranco na fruktozo tveganje za resne neželene učinke, ki jih je treba pretehtati glede na možne koristi nujnega zdravljenja z zdravilom Praxbind.
English: The primary endpoint was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, based on central laboratory determination of dilute thrombin time (dTT) or ecarin clotting time (ECT).
Slovenian: Primarni opazovani dogodek je bil največji odstotek izničenja antikoagulacijskega učinka dabigatrana v 4 urah po uporabi idarucizumaba, ki je temeljil na določitvi razredčitvenega trombinskega časa (dTT) ali ekarinskega časa koagulacije (EKT) v centralnem laboratoriju.
English: The pharmacokinetics of idarucizumab were investigated in 224 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g as intravenous infusion are presented.
Slovenian: Farmakokinetiko idarucizumaba so proučili pri 224 preizkušancih v študijah I. faze, pri čemer so predstavljeni podatki reprezentativne podskupine 6 zdravih preizkušancev, starih od 45 do 64 let, ki so prejeli odmerek 5 g v obliki intravenske infuzije.
English: No anti-idarucizumab antibodies were detected in these subjects prior to the second administration.
Slovenian: Pred drugim dajanjem pri teh preizkušancih niso zaznali protiteles proti idarucizumabu.
English: A causal relationship to idarucizumab could not be established.
Slovenian: Vzročne povezave z idarucizumabom niso dokazali.
English: There are no data for the use of Praxbind in pregnant women.
Slovenian: Podatkov o uporabi zdravila Praxbind pri nosečnicah ni.
English: After administration of Praxbind, other antithrombotic therapy (e.g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved.
Slovenian: Po uporabi zdravila Praxbind lahko drugo antitrombotično terapijo (npr. nizkomolekularni heparin) uvedemo kadarkoli, če je bolnik klinično stabilen in je bila dosežena ustrezna hemostaza.
English: How to use Praxbind
Slovenian: Kako uporabljati zdravilo Praxbind
English: In a subgroup of 6 phase I subjects, idarucizumab was administered a second time, two months after the first administration.
Slovenian: Podskupini 6 oseb v preskušanju I. faze so idarucizumab dajali že drugič dva meseca po prvem dajanju.
English: Preclinical data reveal no special hazard for humans based on repeated dose toxicity studies of up to four weeks in rats and two weeks in monkeys.
Slovenian: Predklinični podatki na osnovi študij o toksičnosti pri ponavljajočih se odmerkih, ki so pri podganah trajale do štiri tedne in pri opicah do dva tedna, ne kažejo posebnega tveganja za človeka.
English: Tell your doctor or nurse - if you are allergic to idarucizumab or to any other of the substances listed in section 6.
Slovenian: Povejte zdravniku ali medicinski sestri: - če ste alergični na idarucizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate gensko bolezen, imenovano dedna intoleranca za fruktozo.
English: After treatment with idarucizumab proteinuria has been observed.
Slovenian: Po zdravljenju z idarucizumabom so opazili proteinurijo.
English: Praxbind (2x2.5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection.
Slovenian: Zdravilo Praxbind (2 x 2,5 g/50 ml) dajemo intravensko v obliki dveh zaporednih infuzij, ki trajata po 5 do 10 minut vsaka, ali kot bolusno injekcijo.
English: No adverse reactions have been identified.
Slovenian: Neželenih učinkov niso ugotovili.
English: LIST OF EXCIPIENTS Excipients: Sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20, water for injection.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: natrijev acetat trihidrat, ocetna kislina, sorbitol, polisorbat 20, voda za injekcije.
English: If Praxbind is administered in these patients, intensified medical care during Praxbind exposure and within 24 hours of exposure is required.
Slovenian: Če zdravilo Praxbind uporabimo pri teh bolnikih, jih moramo med dajanjem zdravila Praxbind in 24 ur po njem intenzivno spremljati.
English: Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see section 5.1).
Slovenian: Pomembni koagulacijski parametri so aktivirani delni tromboplastinski čas (aPTČ), razredčitveni trombinski čas (dTT-diluted Thrombin Time) ali ekarinski čas koagulacije (EKT) (glejte poglavje 5.1).
English: None of the patients re-dosed with idarucizumab tested positive for anti-idarucizumab antibodies.
Slovenian: Pri nobenem od bolnikov, ki so prejeli ponoven odmerek idarucizumaba, test protiteles proti idarucizumabu ni bil pozitiven.
English: In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation of clotting tests have occurred up to 24 hours after administration of idarucizumab (see section 5.1).
Slovenian: Pri podskupini bolnikov je v roku 24 ur po uporabi idarucizumaba prišlo do ponovnih plazemskih koncentracij nevezanega dabigatrana in sočasnega podaljšanja testov strjevanja krvi (glejte poglavje 5.1).
English: • The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL)
Slovenian: • Priporočeni odmerek zdravila Praxbind je 5 g (2 x 2,5 g/50 ml).
English: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
Slovenian: Izničenje terapije z dabigatranom bolnika izpostavi trombotičnemu tveganju, povezanemu z osnovno boleznijo.
English: Renal impairment did not impact the reversal effect of idarucizumab (see section 5.2).
Slovenian: Ledvična okvara ni vplivala na idarucizumabov učinek izničenja antikoagulacijskega učinka (glejte poglavje 5.2).
English: The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL).
Slovenian: Priporočeni odmerek zdravila Praxbind je 5 g (2 x 2,5 g/50 ml).
English: Pre-existing antibodies with cross-reactivity to idarucizumab were detected in approximately 12 % (33/283) of the phase I subjects and 3.8% (19/501) of the patients.
Slovenian: Pri približno 12 % (33/283) preizkušancev v preskušanju I. faze in 3,8 % (19/501) bolnikov so odkrili obstoječa protitelesa z navzkrižno reaktivnostjo na idarucizumab.
English: In one subject, treatment-emergent anti-idarucizumab antibodies were detected after the second administration.
Slovenian: Pri enem preizkušancu so po drugi uporabi opazili iz zdravljenja izvirajoča protitelesa proti idarucizumabu.
English: Idarucizumab is a specific reversal agent for dabigatran.
Slovenian: Idarucizumab je specifična protiučinkovina za dabigatran.
English: Figure 4 - Plasma-levels of unbound dabigatran in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Slovenian: Slika 4 - Ravni nevezanega dabigatrana v plazmi v reprezentativni skupini zdravih preizkušancev (dajanje idarucizumaba ali placeba pri 0 h)
English: Figure 5 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Slovenian: Slika 5 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določeno z dTT, v reprezentativni skupini zdravih preskušancev (dajanje idarucizumaba ali placeba pri 0 h)
English: Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT).
Slovenian: Pomembni koagulacijski parametri so aktivirani delni tromboplastinski čas (aPTČ), razredčitveni trombinski čas (dTT-diluted Thrombin Time) ali ekarinski čas koagulacije (EKT).
English: PHARMACEUTICAL FORM AND CONTENTS 2 vials of 50 mL solution for injection/infusion each
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 2 viali po 50 ml raztopine za injiciranje/infundiranje
English: • volume expanders.
Slovenian: • volumskimi ekspanderji,
English: Preclinical pharmacodynamics
Slovenian: Predklinična farmakodinamika
English: Pradaxa can be given again 24 hours after Praxbind administration.
Slovenian: Ponovna uporaba zdravila Pradaxa je mogoča 24 ur po dajanju zdravila Praxbind.
English: Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises their anticoagulant effect.
Slovenian: Idarucizumab se močno in specifično veže na dabigatran in njegove presnovke ter nevtralizira njihov antikoagulacijski učinek.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Vial label
Slovenian: PODATKI NA PRIMARNI OVOJNINI Nalepka viale
English: • other anticoagulants (e.g. thrombin inhibitors other than dabigatran, Factor Xa inhibitors including low-molecular weight heparin, vitamin K-antagonists, heparin).
Slovenian: vključno z nizkomolekularnim heparinom, antagonisti vitamina K, heparinom).
English: Praxbind is used to rapidly trap dabigatran in order to inactivate its effect.
Slovenian: Zdravilo Praxbind uporabljamo za hitro vezavo dabigatrana in s tem izničenje njegovega učinka.
English: Subjects with a creatinine clearance below 44 mL/min have not been studied in Phase I. Depending on the degree of renal impairment the total clearance was reduced compared to healthy subjects, leading to an increased exposure of idarucizumab.
Slovenian: Glede na stopnjo ledvične okvare se je skupni očistek v primerjavi z zdravimi preizkušanci zmanjšal, kar je povzročilo večjo izpostavljenost idarucizumabu.
English: Figure 1 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in patients from the RE-VERSE AD study (N=487)
Slovenian: Slika 1 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določenega z dTT, pri bolnikih iz študije RE-VERSE AD (N = 487)
English: Figure 3 - Reversal of dabigatran-induced clotting time prolongation determined by aPTT in patients from the RE-VERSE AD study (N=486)
Slovenian: Slika 3 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določenega z aPTČ, pri bolnikih iz študije RE-VERSE AD (N = 486)
English: No dose adjustment is required in renally impaired patients.
Slovenian: Bolnikom z ledvično okvaro odmerka ni treba prilagajati.
English: Figure 6 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Slovenian: Slika 6 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določeno z EKT, v reprezentativni skupini zdravih preizkušancev (dajanje idarucizumaba ali placeba pri 0 h)
English: What Praxbind contains - The active substance is idarucizumab.
Slovenian: Kaj vsebuje zdravilo Praxbind - Učinkovina je idarucizumab.
English: Figure 2 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in patients from the RE-VERSE AD study (N=487)
Slovenian: Slika 2 - Izničenje z dabigatranom povzročenega podaljšanja časa strjevanja, določenega z EKT, pri bolnikih iz študije RE-VERSE AD (N = 487)
English: NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion
Slovenian: IME ZDRAVILA Praxbind 2,5 g/50 ml raztopina za injiciranje/infundiranje
English: Praxbind binds specifically to dabigatran and reverses its anticoagulant effect.
Slovenian: Zdravilo Praxbind se veže specifično na dabigatran in izniči njegov antikoagulacijski učinek.