natgillin/translations-raw huggingface dataset:
This occurred 1-24 hours after administration of idarucizumab mainly at timepoints ≥12 hours.
To se javilo 1-24 sata nakon primjene idarucizumaba uglavnom na vremenskim točkama ≥ 12 sati.
There is no information on the effects of this medicine in pregnant or breast-feeding women.
Nema podataka o učincima ovog lijeka u trudnica ili dojilja.
The transient proteinuria is not indicative of renal damage, which should be taken into account for urine testing.
Prolazna proteinurija ne upućuje na oštećenje bubrega što treba uzeti u obzir pri pretrazi urina.
One prospective, open-label, non-randomized, uncontrolled study (RE-VERSE AD) was conducted to investigate the treatment of adult patients who presented with dabigatran-related life-threatening or uncontrolled bleeding (Group A) or who required emergency surgery or urgent procedures (Group B).
Provedeno je jedno prospektivno, otvoreno, nerandomizirano, nekontrolirano ispitivanje (RE-VERSE AD) kako bi se ispitalo liječenje odraslih bolesnika koji su imali po život opasno stanje ili nekontrolirano krvarenje, a vezano uz primjenu dabigatrana (skupina A) ili im je bio potreban hitni kirurški zahvat ili hitni postupci (skupina B).
This medicine has been designed to only bind to dabigatran.
Ovaj lijek je razvijen samo u svrhu vezanja za dabigatran.
Hereditary fructose intolerance
Nasljedna nepodnošljivost fruktoze
It is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity, approximately 300-fold more potent than the binding affinity of dabigatran for thrombin.
To je fragment humaniziranog monoklonskog antitijela (Fab) koji se za dabigatran veže vrlo visokim afinitetom, približno 300 puta potentnije od afiniteta vezivanja dabigatrana za trombin.
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To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate (see section 4.2).
Radi smanjenja ovog rizika, potrebno je razmotriti nastavljanje terapije antikoagulansom čim je to medicinski prikladno (vidjeti dio 4.2).
In these studies the doses of idarucizumab ranged from 20 mg to 8 g and the infusion times ranged from 5 minutes to 1 hour.
Doze idarucizumaba u ovim ispitivanjima varirale su od 20 mg do 8 g, a trajanje infuzije od 5 minuta do 1 sata.
Idarucizumab was rapidly eliminated with a total clearance of 47.0 mL/min (gCV 18.4 %), an initial half-life of 47 minutes (gCV 11.4 %) and a terminal half-life of 10.3 h (gCV 18.9 %).
Idarucizumab se brzo eliminirao uz ukupni klirens od 47,0 ml/min (gCV 18,4%), početni poluvijek od 47 minuta (gCV 11,4%) i terminalni poluvijek od 10,3 h (gCV 18,9%).
After intravenous administration of 5 g idarucizumab, 32.1 % (gCV 60.0 %) of the dose was recovered in urine within a collection period of 6 hours and less than 1 % in the following 18 hours.
Nakon intravenske primjene 5 g idarucizumaba, 32,1% (gCV 60,0%) doze se pojavilo (engl. recovered) u urinu unutar perioda prikupljanja od 6 sati, a manje od 1% u sljedećih 18 sati.
A trauma model in pigs was performed using a blunt liver injury after dosing with dabigatran to achieve supratherapeutic concentrations of about 10-fold of human plasma levels.
Model traume je izveden na svinjama primjenom tupe ozljede jetre nakon doziranja dabigatranom s ciljem postizanja supraterapijskih koncentracija od oko 10-puta viših od razina u humanoj plazmi.
Studies to assess the potential reproductive effects of idarucizumab have not been performed.
Ispitivanja u svrhu ocjene potencijalnih učinaka idarucizumaba na reprodukciju nisu provedena.
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Praxbind should be discontinued immediately and appropriate therapy initiated.
Ako se pojavi anafilaktička reakcija ili druga ozbiljna alergijska reakcija, potrebno je odmah prekinuti primjenu Praxbinda i započeti odgovarajuću terapiju.
50 mL solution in a glass vial (type I glass), with a butyl rubber stopper, an aluminium cap and a label with integrated hanger.
50 ml otopine u staklenoj bočici (staklo tipa I) sa čepom od butilne gume, aluminijskim zatvaračem i naljepnicom s integriranom vješalicom.
Thromboembolic Events
Tromboembolički događaji
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 4.9 Overdose
Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
Most patients in both Groups A and B, achieved complete reversal of the anticoagulant effect of dabigatran (dTT: 98.7%; ECT: 82.2%; aPTT: 92.5% of evaluable patients, respectively) in the first 4 hours after administration of 5 g idarucizumab.
Većina bolesnika, u obje skupine, A i B, postigli su potpuno poništenje antikoagulacijskog učinka dabigatrana (dTT: 98,7%; ECT 82,2%; aPTT: 92,5% bolesnika koji su se mogli procijeniti) u prva 4 sata nakon primjene 5 g idarucizumaba.
• if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or
• ako bi potencijalno ponovno krvarenje bilo po život opasno, a opažena su produljena vremena zgrušavanja ili
Based on pharmacokinetic data from 347 patients with different degrees of renal function (median creatinine clearance 21 - 99 mL/min) it is estimated that mean idarucizumab exposure (AUC0-24h) increases by 38% in patients with mild (CrCl 50-<80 mL/min), by 90% in moderate (30-<50 mL/min) and by 146% in severe (0-<30 mL/min) renal impairment.
Na temelju farmakokinetičkih podataka od 347 bolesnika s različitim stupnjevima bubrežne funkcije (medijan klirensa kreatinina 21-99 ml/min) procijenjeno je da se srednja izloženost idarucizumabu (AUC0-24 h) povećava za 38% u bolesnika s blagim (CrCl 50-<80 ml/min), za 90% u bolesnika s umjerenim (30-<50 ml/min) i za 146% u bolesnika s teškim (0-<30 ml/min) oštećenjem bubrega.
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.
Praxbind je antagonist specifičan za dabigatran (Pradaxu), lijek za razrjeđivanje krvi koji blokira tvar u tijelu uključenu u stvaranje krvnog ugruška.
After you have received Praxbind, your doctor will decide on the continuation of your treatment to prevent blood clot formation.
Nakon što ste primili Praxbind, Vaš će liječnik odlučiti o nastavljanju liječenja radi sprječavanja stvaranja krvnih ugrušaka.
A complete and sustained reversal of dabigatran-induced clotting time prolongation was observed immediately after the idarucizumab infusion, lasting over the entire observation period of at least 24 h.
Potpuno i održano poništenje produljenja vremena zgrušavanja induciranog dabigatranom zapaženo je odmah nakon infuzije idarucizumaba i trajalo je tijekom cijelog razdoblja praćenja od najmanje 24 h.
After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature.
Nakon otvaranja bočice, kemijska i fizikalna stabilnost idarucizumaba tijekom uporabe pokazana je za 6 sati na sobnoj temperaturi.
Idarucizumab exhibited multiphasic disposition kinetics and limited extravascular distribution.
Idarucizumab je pokazao kinetiku dispozicije u više faza i ograničenu ekstravaskularnu distribuciju.
No dose adjustment is required in elderly patients aged 65 years and above (see section 5.2).
Nije potrebna prilagodba doze u bolesnika starijih od 65 godina (vidjeti dio 5.2).
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Representative values for pharmacokinetic and pharmacodynamics parameters were established on the basis of healthy subjects aged 45-64 years receiving 5 g idarucizumab (see sections 5.1 and 5.2).
Reprezentativne vrijednosti za farmakokinetičke i farmakodinamičke parametre ustanovljene su na temelju zdravih dobrovoljaca u dobi od 45-64 godina koji su primili 5 g idarucizumaba (vidjeti dijelove 5.1 i 5.2).
• recurrence of clinically relevant bleeding together with prolonged clotting times, or
• ponovna pojava klinički značajnog krvarenja zajedno s produljenim vremenom zgrušavanja ili
PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SKLOPIVA KUTIJA
Immediately after the administration of idarucizumab, the plasma concentrations of unbound dabigatran were reduced by more than 99 %, resulting in levels with no anticoagulant activity.
Odmah nakon primjene idarucizumaba, koncentracije nevezanog dabigatrana u plazmi smanjile su se za više od 99%, što je rezultiralo razinama bez antikoagulacijske aktivnosti.
Additionally, no idarucizumab binding to human reproductive tissues was observed in a tissue cross-reactivity study.
Pored toga, vezanje idarucizumaba na humana reproduktivna tkiva nije zapaženo u ispitivanju tkivne križne reaktivnosti.
Each 50 mL vial contains 2 g sorbitol and 25 mg sodium (see section 4.4).
Jedna bočica od 50 ml sadrži 2 g sorbitola i 25 mg natrija (vidjeti dio 4.4).
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.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza u trajanju do četiri tjedna u štakora i dva tjedna u majmuna.
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.
Praxbind otopina za injekciju/infuziju je bistra do blago zamućena, bezbojna do blago žuta otopina dostupna u staklenoj bočici zatvorenoj čepom od butilne gume i aluminijskim zatvaračem.
These tests were used to assess the anticoagulant effect of dabigatran.
Ove su se pretrage koristile za procjenu antikoagulacijskog učinka dabigatrana.
In a phase III trial the safety of Praxbind has been evaluated in 503 patients, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with Pradaxa (dabigatran etexilate), as well as in 224 volunteers in phase I trials.
U ispitivanju faze III, sigurnost Praxbinda se procjenjivala u 503 bolesnika koji su nekontrolirano krvarili ili su trebali biti podvrgnuti hitnom kirurškom zahvatu ili postupcima, a bili su na terapiji Pradaxom (dabigatraneteksilatom), kao i u 224 dobrovoljca u ispitivanjima faze I.
Preclinical investigations with idarucizumab have shown no interactions with
Pretklinička istraživanja idarucizumaba nisu pokazala interakcije s
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.
Prethodno postojeća antitijela s križnom reaktivnošću na idarucizumab su otkrivena u približno 12% (33/283) ispitanika iz ispitivanja faze I i 3,8% (19/501) bolesnika.
Since dabigatran is also excreted primarily via the kidneys, increases in the exposure to dabigatran are also seen with worsening renal function.
Budući da se dabigatran također izlučuje primarno putem bubrega, povećanja u izloženosti dabigatranu zapažena su i u bolesnika s pogoršanom funkcijom bubrega.
What Praxbind is and what it is used for
Što je Praxbind i za što se koristi
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“.
Praxbind contains sodium
Praxbind sadrži natrij
The line must be flushed with sodium chloride 9 mg/ml (0.9 %) solution for injection prior to and at the end of infusion.
Linija se prije i nakon završetka infuzije mora isprati otopinom natrijeva klorida od 9 mg/ml (0,9%) za injekciju.
It will not reverse the effects of other anticoagulants.
On neće poništiti učinke drugih antikoagulanasa.
To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.
Radi smanjenja ovog rizika, potrebno je razmotriti nastavljanje terapije antikoagulansom čim je to medicinski prikladno.
Idarucizumab has been studied in 58 patients with varying degrees of hepatic impairment.
Idarucizumab je ispitan u 58 bolesnika s raznim stupnjevima oštećenja jetre.
Three randomised, double-blind, placebo-controlled Phase I studies in 283 subjects (224 treated with idarucizumab) were conducted to assess the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of idarucizumab, given alone or after administration of dabigatran etexilate.
Provedena su tri randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze I na 283 ispitanika (224 liječenih idarucizumabom) kako bi se ocijenila sigurnost, djelotvornost, podnošljivost, farmakokinetika i farmakodinamika idarucizumaba, primijenjenog u obliku monoterapije ili nakon primjene dabigatraneteksilata.
A value in the normal range after administration of idarucizumab indicates that a patient is no longer anticoagulated.
Vrijednost u normalnom rasponu nakon primjene idarucizumaba upućuje da bolesnik više nije antikoaguliran.
The transient proteinuria usually peaked about 4 h after idarucizumab administration and normalised within 12-24 hours.
Prolazna proteinurija je obično dosegnula vršne vrijednosti oko 4 sata nakon primjene idarucizumaba, a normalizirala se unutar 12-24 sata.
Thus idarucizumab will not reverse the effects of other anticoagulants.
idarucizumab neće poništiti učinke drugih antikoagulanasa.
Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required:
Praxbind je specifičan antagonist dabigatrana te je indiciran u odraslih bolesnika liječenih Pradaxom (dabigatraneteksilatom) kada je potrebno brzo poništenje njegovog antikoagulacijskog učinka:
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.
U usporedbi s 272 bolesnika bez oštećenja jetre, medijan AUC-a idarucizumaba bio je promijenjen za -6%, 37% i 10% u bolesnika s povišenjem AST-a/ALT-a od 1 do <2x GGN (N=34), 2 do <3x GGN (N=3) odnosno >3x GGN (N=21).
Serum samples from 283 subjects in phase I trials (224 volunteers treated with idarucizumab) and 501 patients were tested for antibodies to idarucizumab before and after treatment.
Uzorci seruma 283 ispitanika u ispitivanjima faze I (224 dobrovoljca liječena idarucizumabom) i 501 bolesnika ispitani su na prisutnost antitijela na idarucizumab prije i nakon liječenja.
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.
Ovaj lijek sadrži 50 mg natrija po dozi, što odgovara 2,5% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO-a za odraslu osobu.
No incompatibilities between Praxbind and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.
Nisu zapažene inkompatibilnosti između Praxbinda i infuzijskih kompleta od polivinilklorida, polietilena ili poliuretana ili polipropilenskih štrcaljki.
Treatment-emergent possibly persistent anti-idarucizumab antibodies with low titers were observed in 4 % (10/224) of the phase I subjects and 1.6% (8/501) of the patients suggesting a low immunogenic potential of idarucizumab.
Antitijela na idarucizumab nastala tijekom liječenja, moguće perzistirajuća, zapažena su u niskom titru u 4% (10/224) ispitanika u ispitivanjima faze I i 1,6% (8/501) bolesnika, što ukazuje na nizak imunogeni potencijal idarucizumaba.
There are no data on the effect of Praxbind on fertility (see section 5.3).
Nema podataka o učinku Praxbinda na plodnost (vidjeti dio 5.3).
No anti-idarucizumab antibodies were detected in these subjects prior to the second administration.
U ovih ispitanika nisu otkrivena antitijela na idarucizumab prije druge primjene.
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.
Međutim u podskupini bolesnika, zamijećena je ponovna pojava plazmatskih razina nevezanog dabigatrana i prateće povišenje testova zgrušavanja, moguće uslijed redistribucije dabigatrana s periferije.
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.
Učinci povezani s liječenjem nisu utvrđeni na reproduktivnom tkivu niti jednog spola tijekom intravenskih ispitivanja toksičnosti ponovljenih doza u trajanju do četiri tjedna u štakora i dva tjedna u majmuna.
Pack size of 2 vials.
Veličina pakiranja od 2 bočice.
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
NAČIN I PUT(EVI) PRIMJENE LIJEKA Intravenska primjena
4 factor), activated PCCs (aPCCs) and recombinant factor VIIa.
faktor 3 i faktor 4), aktiviranim koncentratima protrombinskog kompleksa (aPPC-i) i rekombinantnim faktorom VIIa;
What Praxbind contains - The active substance is idarucizumab.
Što Praxbind sadrži - Djelatna tvar je idarucizumab.
There is no information on the use of Praxbind in children.
Nema informacija o primjeni Praxbinda u djece.
• coagulation factor concentrates, such as prothrombin complex concentrates (PCCs, e.g. 3 factor and
• koncentratima faktora koagulacije, poput koncentrata protrombinskog kompleksa (PCC-i, npr.
Effect of idarucizumab on the exposure and anticoagulant activity of dabigatran
Učinak idarucizumaba na izloženost i antikoagulacijsku aktivnost dabigatrana
Tell your doctor or nurse - if you are allergic to idarucizumab or to any other of the substances listed in section 6.
Obavijestite svog liječnika ili medicinsku sestru - ako ste alergični na idarucizumab ili neke druge tvari navedene u dijelu 6. - ako imate genetsku bolest koja se naziva nasljedna nepodnošljivost fruktoze.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection/infusion contains 50 mg idarucizumab.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine za injekciju/infuziju sadrži 50 mg idarucizumaba.
6.1 List of excipients sodium acetate trihydrate acetic acid sorbitol polysorbate 20 water for injection
6.1 Popis pomoćnih tvari natrijev acetat trihidrat acetatna kiselina sorbitol polisorbat 20 voda za injekcije
Patients being treated with dabigatran have underlying disease states that predispose them to thromboembolic events.
Bolesnici liječeni dabigatranom imaju stanja osnovnih bolesti koja ih predodređuju za tromboemboličke događaje.
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.
Medijan vršne izloženosti dabigatranu u zdravih ispitanika bio je u rasponu primjene 150 mg dabigatraneteksilata dvaput dnevno u bolesnika.
In a subgroup of 6 phase I subjects, idarucizumab was administered a second time, two months after the first administration.
U podskupini od 6 ispitanika u ispitivanjima faze I, idarucizumab je primijenjen drugi put, dva mjeseca nakon prve primjene.
Restricted to hospital use only.
Samo za bolničku primjenu.
The highest single dose of Praxbind studied in healthy subjects was 8 g. No safety signals have been identified in this group.
Najviša jednokratna doza Praxbinda ispitana u zdravih dobrovoljaca bila je 8 g.
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.
U bolesnika s nasljednom nepodnošljivošću fruktoze postoji rizik od ozbiljnih nuspojava koji se mora odvagnuti u odnosu na korist od hitnog liječenja Praxbindom.
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.
Nije opaženo da oštećenje jetre, procijenjeno prema oštećenju jetre utvrđenom po povišenim vrijednostima na testovima jetrene funkcije, utječe na farmakokinetiku idarucizumaba.
Reversal was only evaluable for those patients showing prolonged coagulation times prior to idarucizumab treatment.
Poništenje učinka moglo se procijeniti samo u onih bolesnika koji su prije liječenja idarucizumabom imali produljeno vrijeme koagulacije.
OTHER - Printing on inside of lid
DRUGO - ispis na unutarnjoj strani poklopca
What Praxbind is used for
Za što se Praxbind koristi
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).
Ponovna pojava plazmatskih koncentracija nevezanog dabigatrana i istodobno produljenje vrijednosti koagulacijskih testova pojavili su se u podskupini bolesnika do 24 sati nakon primjene idarucizumaba (vidjeti dio 5.1).
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.
Dabigatran produžuje vrijeme zgrušavanja koagulacijskih markera poput razrijeđenog trombinskog vremena (dTT), trombinskog vremena (TT), aktiviranog parcijalnog tromboplastinskog vremena (aPTT) i ekarinskog vremena zgrušavanja (ECT), što pruža približan uvid u intenzitet antikoagulacije.
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.
Stoga se u bolesnika s nasljednom nepodnošljivošću fruktoze mora odvagnuti rizik od liječenja Praxbindom naspram potencijalne koristi od ovakvog hitnog liječenja.
No dose adjustment is required in patients with hepatic injury (see section 5.2).
Nije potrebna prilagodba doze u bolesnika s oštećenjem jetre (vidjeti dio 5.2).
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.
Liječenje idarucizumabom normaliziralo je i omjer vremena kašnjenja početka stvaranja trombina te omjer vremena i vršne vrijednosti u odnosu na početne vrijednosti kao što se utvrdilo 0,5 i 12 sati nakon završetka infuzije idarucizumaba.
24 hours after the idarucizumab infusion, re-administration of dabigatran etexilate resulted in expected anticoagulant activity.
Ponovna primjena dabigatraneteksilata 24 sata nakon infuzije idarucizumaba rezultirala je očekivanom antikoagulantnom aktivnošću.
Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
Izostanak antitrombotske terapije izlaže bolesnike riziku od tromboze u njihovoj osnovnoj bolesti ili stanju.
Praxbind is used to rapidly trap dabigatran in order to inactivate its effect.
Praxbind se primjenjuje za brzo hvatanje dabigatrana kako bi se poništio njegov učinak.
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).
Praxbind uzrokuje prolaznu proteinuriju kao fiziološku reakciju na pretjerani priljev (engl. overflow) proteina bubrezima nakon bolusa/kratkotrajne intravenske primjene 5 g idarucizumaba (vidjeti dio 5.2).
How to store Praxbind
Kako čuvati Praxbind
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.
U bolesnika s poznatom preosjetljivošću (npr. anafilaktoidnom reakcijom) na idarucizumab ili neku od pomoćnih tvari, potrebno je oprezno odvagnuti rizik primjene Praxbinda naspram potencijalne koristi ovakvog hitnog liječenja.
What Praxbind is
Što je Praxbind