FrancophonIA/ELRC3.0 huggingface dataset:
English: The transient proteinuria is not indicative of renal damage, which should be taken into account for urine testing.
Slovenian: Prehodna proteinurija ne nakazuje na okvaro ledvic, kar moramo upoštevati pri preiskavah urina.
English: For additional instructions for use and handling see section 6.6.
Slovenian: Za dodatna navodila o uporabi ali dajanju zdravila glejte poglavje 6.6.
English: • recurrence of clinically relevant bleeding together with prolonged clotting times, or
Slovenian: • ponovitev klinično pomembne krvavitve skupaj s podaljšanjem časa strjevanja krvi, ali
English: • if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or
Slovenian: • če bi bila potencialna ponovna krvavitev življenjsko ogrožujoča in je opažen podaljšan čas strjevanja krvi, ali
English: Based on its mechanism of action and the characteristics of proteins no carcinogenic or genotoxic effects are anticipated.
Slovenian: Glede na mehanizem delovanja in značilnosti beljakovin kancerogeni ali genotoksični učinki niso pričakovani.
English: Your doctor will continue treating you with medicines used to prevent the formation of blood clots as soon as your medical condition allows.
Slovenian: Vaš zdravnik bo nadaljeval zdravljenje z zdravili, ki se uporabljajo za preprečevanje krvnih strdkov, čim bo to dovoljevalo vaše zdravstveno stanje.
English: For storage conditions after opening of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po prvem odprtju zdravila glejte poglavje 6.3.
English: What Praxbind is and what it is used for 2.
Slovenian: Kaj je zdravilo Praxbind in za kaj ga uporabljamo 2.
English: What you need to know when you receive Praxbind 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Praxbind 3.
English: Restarting Antithrombotic Therapy
Slovenian: Ponovno uvajanje antitrombotične terapije
English: Idarucizumab effectively and rapidly reversed the life-threatening bleeding within 15 min after the injection.
Slovenian: Idarucizumab je učinkovito in hitro odpravil življenjsko nevarno krvavitev v 15 minutah po injiciranju.
English: Based on pharmacokinetic data from 12 patients with liver disease, the AUC of idarucizumab was increased by 10% as compared to patients without liver disease.
Slovenian: Na podlagi farmakokinetičnih podatkov 12 bolnikov z boleznijo jeter se je AUC idarucizumaba povišal za 10 % v primerjavi z bolniki brez bolezni jeter.
English: Studies to evaluate the mutagenic and carcinogenic potential of idarucizumab have not been performed.
Slovenian: Študije za ocenitev mutagenega in kancerogenega potenciala idarucizumaba niso bile opravljene.
English: Based on these data and the extent of reversal of the anticoagulant effect of dabigatran in patients, renal impairment does not impact the reversal effect of idarucizumab.
Slovenian: Na osnovi teh podatkov in obsegu izničenja antikoagulacijskega učinka dabigatrana pri bolnikih ledvična okvara nima vpliva na izničevalni učinek idarucizumaba.
English: Thrombin generation parameters
Slovenian: Parametri nastajanja trombina
English: Several pathways have been described that may contribute to the metabolism of antibodies.
Slovenian: Opisali so več poti, ki lahko prispevajo k presnovi protiteles.
English: This medicine contains 50 mg sodium (main component of cooking/table salt) per dose.
Slovenian: To zdravilo vsebuje 50 mg natrija (glavna sestavina kuhinjske soli) na odmerek.
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate (see section 4.2).
Slovenian: Da bi zmanjšali to tveganje, je treba razmisliti o ponovni antikoagulacijski terapiji takoj, ko je to zdravstveno ustrezno (glejte poglavje 4.2).
English: 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).
Slovenian: Izvedena je bila ena prospektivna, odprta, nerandomizirana, nenadzorovana študija (RE-VERSE AD) za proučitev zdravljenja odraslih bolnikov, ki imajo življenjsko nevarno ali nenadzorovano krvavitev, povezano z dabigatranom (skupina A), ali potrebujejo nujno operacijo ali nujni poseg (skupina B).
English: Praxbind is for single-use only and does not contain preservatives (see section 6.3).
Slovenian: Zdravilo Praxbind je namenjeno samo za enkratno uporabo in ne vsebuje konzervansov (glejte poglavje 6.3).
English: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product shall be used immediately after opening.
Slovenian: Z mikrobiološkega vidika je treba zdravilo porabiti takoj po odprtju, razen če uporabljena metoda odpiranja izključuje tveganje za mikrobno kontaminacijo.
English: Reversal was only evaluable for those patients showing prolonged coagulation times prior to idarucizumab treatment.
Slovenian: Izničenje je bilo mogoče oceniti samo pri tistih bolnikih, ki so pred zdravljenjem z idarucizumabom izkazali podaljšane čase koagulacije.
English: The recommended dose of Praxbind contains 4 g sorbitol as an excipient.
Slovenian: Priporočeni odmerek zdravila Praxbind vsebuje 4 g sorbitola kot pomožno snov.
English: Based on the pharmacokinetic properties and the high specificity in binding to dabigatran, clinically relevant interactions with other medicinal products are considered unlikely.
Slovenian: Na podlagi farmakokinetičnih lastnosti in velike specifičnosti vezave na dabigatran klinično pomembne interakcije z drugimi zdravili niso verjetne.
English: Tell your doctor, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
English: Praxbind is used in adults in emergency situations where your doctor decides that rapid inactivation of the effect of Pradaxa is required - For emergency surgery/urgent procedures - In life-threatening or uncontrolled bleeding.
Slovenian: Zdravilo Praxbind uporabljamo pri odraslih v nujnih primerih, v katerih zdravnik odloči, ali je potrebno hitro izničenje učinka zdravila Pradaxa: - za nujne operacije/nujne posege, - pri življenjsko nevarnih ali nenadzorovanih krvavitvah.
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Podatek ni potreben.
English: Idarucizumab alone has shown no procoagulant effect measured as ETP.
Slovenian: Sam idarucizumab ni pokazal prokoagulacijskega učinka, izmerjenega z ETP.
English: This suggests that idarucizumab has no prothrombotic effect.
Slovenian: To kaže na dejstvo, da idarucizumab nima protrombotičnega učinka.
English: In patients with hereditary fructose intolerance, parenteral administration of sorbitol has been associated with reports of hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death.
Slovenian: Pri bolnikih z dedno intoleranco na fruktozo je bilo parenteralno dajanje sorbitola povezano s poročili o hipoglikemiji, hipofosfatemiji, metabolični acidozi, zvišanjem ravni sečne kisline, akutni jetrni odpovedi z odpovedjo izločevalne in sintetične funkcije ter smrti.
English: This medicine has been designed to only bind to dabigatran.
Slovenian: To zdravilo je bilo zasnovano samo za vezavo na dabigatran.
English: Idarucizumab is produced by recombinant DNA technology in Chinese Hamster Ovary cells.
Slovenian: Idarucizumab je pridobljen s tehnologijo rekombinantne DNA v celicah jajčnika kitajske hrčice.
English: In Phase I studies Praxbind has been investigated in subjects with a creatinine clearance ranging from 44 to 213 mL/min.
Slovenian: V študijah I. faze so zdravilo Praxbind proučili pri preizkušancih s kreatininskim očistkom od 44 do 213 ml/min.
English: 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.
Slovenian: Popolno in trajno izničenje z dabigatranom povzročenega podaljšanja časa strjevanja so opazili takoj po infundiranju idarucizumaba in je trajalo ves čas najmanj 24-urnega opazovanega obdobja.
English: The majority of the patients showed sustained reversal of dabigatran plasma concentrations up to 12 hours (≥90%).
Slovenian: Pri večini bolnikov je bilo zaznati do 12 ur trajajoče izničenje plazemskih koncentracij dabigatrana (≥ 90%).
English: Administration of a second 5 g dose of Praxbind may be considered in the following situations:
Slovenian: Za ponovno dajanje 5 g odmerka zdravila Praxbind se lahko odločimo v naslednjih primerih:
English: Hereditary fructose intolerance
Slovenian: Dedna intoleranca na fruktozo
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.
Slovenian: Da bi zmanjšali to tveganje, je treba razmisliti o ponovni antikoagulacijski terapiji takoj, ko je to zdravstveno ustrezno.
English: Following the intravenous infusion of a 5 g dose, the geometric mean volume of distribution at steady state (Vss) was 8.9 L (geometric coefficient of variation (gCV) 24.8 %).
Slovenian: Po intravenskem infundiranju odmerka 5 g je bila geometrična sredina volumna porazdelitve v stanju dinamičnega ravnovesja (Vss) 8,9 l (geometrični koeficient variacije (gCV) 24,8 %).
English: 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.
Slovenian: Po intravenskem dajanju 5 g idarucizumaba je bilo 32,1 % (gCV 60,0 %) odmerka prestreženega v urinu v 6-urnem zbiranju in manj kot 1 % v naslednjih 18 urah.
English: It will not remove other medicines used to prevent the formation of blood clots.
Slovenian: Drugih zdravil, ki se uporabljajo za preprečevanje krvnih strdkov, ne bo odstranilo.
English: After dabigatran has been removed from your body, you are not protected from the formation of blood clots.
Slovenian: Ko je dabigatran odstranjen iz vašega telesa, niste več zaščiteni pred nastankom krvnih strdkov.
English: After you have received Praxbind, your doctor will decide on the continuation of your treatment to prevent blood clot formation.
Slovenian: Ko boste zdravilo Praxbind prejeli, se bo zdravnik odločil o nadaljevanju zdravljenja za preprečevanje nastajanja krvnih strdkov.
English: It will not reverse the effects of other anticoagulants (see section 5.1).
Slovenian: Ne izniči učinkov drugih antikoagulantov (glejte poglavje 5.1).
English: Detailed instructions for your doctor or nurse on how to administer Praxbind can be found at the end of this package leaflet (see 'Handling instructions').
Slovenian: Podrobna navodila za dajanje zdravila Praxbind za zdravnika ali medicinsko sestro se nahajajo na koncu tega navodila za uporabo (glejte 'Navodila za ravnanje z zdravilom').
English: 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.
Slovenian: Takoj po dajanju idarucizumaba so se koncentracije nevezanega dabigatrana v plazmi zmanjšale za več kot 99%, kar je povzročilo ravni brez antikoagulacijskega delovanja.
English: There is no information on the effects of this medicine in pregnant or breast-feeding women.
Slovenian: Ni informacij o učinku tega zdravila pri nosečnicah ali ženskah, ki dojijo.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Praxbind should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi anafilaktična reakcija ali druga resna alergijska reakcija, je treba dajanje zdravila Praxbind takoj prekiniti in uvesti ustrezno zdravljenje.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Praxbind in one or more subsets of the paediatric population in the prevention and treatment of dabigatran associated haemorrhage (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Praxbind za eno ali več podskupin pediatrične populacije za preprečevanje in zdravljenje krvavitve, povezane z dabigatranom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Additionally, no idarucizumab binding to human reproductive tissues was observed in a tissue cross-reactivity study.
Slovenian: Poleg tega niso opazili vezave idarucizumaba na reproduktivna tkiva pri ljudeh v študiji navzkrižne reaktivnosti.
English: Since dabigatran is also excreted primarily via the kidneys, increases in the exposure to dabigatran are also seen with worsening renal function.
Slovenian: Ker se tudi dabigatran izloča predvsem preko ledvic, je pri slabšanju ledvične funkcije opaženo tudi povečanje izpostavljenosti dabigatranu.
English: 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 %).
Slovenian: Idarucizumab se je hitro izločil s skupnim očistkom 47,0 ml/min (gCV 18,4 %), začetno razpolovno dobo 47 minut (gCV 11,4 %) in končno razpolovno dobo 10,3 h (gCV 18,9 %).
English: Restricted to hospital use only.
Slovenian: Samo za bolnišnično uporabo.
English: Based on population pharmacokinetic analyses, sex, age, and race do not have a clinically meaningful effect on the pharmacokinetics of idarucizumab.
Slovenian: Na podlagi populacijske farmakokinetične analize spol, starost in rasa niso imeli klinično pomembnega vpliva na farmakokinetiko idarucizumaba.
English: This occurred 1-24 hours after administration of idarucizumab mainly at timepoints ≥12 hours.
Slovenian: Do tega je prišlo 1 do 24 ur po dajanju idarucizumaba zlasti ob času ≥ 12 ur.
English: Mild symptoms of potential hypersensitivity (pyrexia, bronchospasm, hyperventilation, rash or pruritus) were reported.
Slovenian: Poročali so o blagih znakih morebitne preobčutljivosti (pireksiji, bronhospazmu, hiperventilaciji, izpuščaju ali srbežu).
English: 24 hours after the idarucizumab infusion, re-administration of dabigatran etexilate resulted in expected anticoagulant activity.
Slovenian: 24 ur po infundiranju idarucizumaba je ponovnemu dajanju dabigatran eteksilata sledila pričakovana antikoagulacijska aktivnost.
English: Each 50 mL vial contains 2 g sorbitol and 25 mg sodium (see section 4.4).
Slovenian: Ena viala po 50 ml vsebuje 2 g sorbitola in 25 mg natrija (glejte poglavje 4.4).
English: 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.
Slovenian: Je fragment humaniziranega monoklonskega protitelesa (Fab), ki se veže na dabigatran z zelo veliko afiniteto, približno 300-krat močnejšo od vezavne afinitete dabigatrana za trombin.
English: Please note this medicine is mainly used in emergency situations and the doctor will have decided that you needed it. - Keep this leaflet.
Slovenian: To zdravilo se največkrat uporablja v nujnih primerih, v katerih bo zdravnik odločil, ali ga potrebujete.
English: Other medicines and Praxbind
Slovenian: Druga zdravila in zdravilo Praxbind
English: Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate.
Slovenian: Zdravljenje z zdravilom Praxbind lahko uporabljamo sočasno z drugimi standardnimi podpornimi ukrepi, ki jih je treba izvajati zdravstveno ustrezno.
English: 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.
Slovenian: Varnost zdravila Praxbind so ocenili v preskušanju III. faze pri 503 bolnikih, ki so imeli nenadzorovano krvavitev ali pri katerih je bila potrebna nujna operacija ali poseg in so se zdravili z zdravilom Pradaxa (dabigatran eteksilat), ter pri 224 prostovoljcih v preskušanjih I. faze.
English: Thus idarucizumab will not reverse the effects of other anticoagulants.
Slovenian: Zato idarucizumab ne izniči učinkov drugih antikoagulantov.
English: 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:
Slovenian: Zdravilo Praxbind je specifična protiučinkovina za dabigatran in je indicirano pri odraslih bolnikih, zdravljenih z zdravilom Pradaxa (dabigatran eteksilat), ko je potrebno hitro izničenje njegovega antikoagulacijskega učinka:
English: These tests were used to assess the anticoagulant effect of dabigatran.
Slovenian: Ti testi so bili uporabljeni za ocenitev antikoagulacijskega učinka dabigatrana.
English: D-88397 Biberach an der Riss Germany
Slovenian: D-88397 Biberach an der Riss Nemčija
English: 4 factor), activated PCCs (aPCCs) and recombinant factor VIIa.
Slovenian: npr. 3-faktorski in 4-faktorski), aktivirani PCC-ji (aPCC-ji) in rekombinantni faktor VIIa;
English: The line must be flushed with sodium chloride 9 mg/ml (0.9 %) solution for injection prior to and at the end of infusion.
Slovenian: Linijo je treba pred začetkom in po koncu infundiranja izprati z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje.
English: 50 mL solution in a glass vial (type I glass), with a butyl rubber stopper, an aluminium cap and a label with integrated hanger.
Slovenian: 50 ml raztopine v stekleni viali (s steklom tipa I), z zamaškom iz butilne gume, aluminijasto zaporko in nalepko z vgrajenim obešalnikom.
English: Idarucizumab has been studied in 58 patients with varying degrees of hepatic impairment.
Slovenian: Idarucizumab je bil preučevan pri 58 bolnikih z različnimi stopnjami jetrne okvare.
English: 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.
Slovenian: Pri prašičih so izvedli travmatski model in sicer s topo poškodbo jeter po odmerjanju dabigatrana, da bi dosegli supraterapevtske koncentracije, približno 10-krat večje od ravni v človeški plazmi.
English: 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.
Slovenian: Na podlagi farmakokinetičnih podatkov 347 bolnikov z različnimi stopnjami ledvične okvare (mediana kreatininskega očistka 21-99 ml/min) so ocenili, da se povprečna izpostavljenost idarucizumabu (AUC0-24 h) poveča za 38 % pri bolnikih z blago ledvično okvaro (CrCl 50-< 80 ml/min), za 90 % pri bolnikih z zmerno ledvično okvaro (30-< 50 ml/min) in za 146 % pri bolnikih s hudo ledvično okvaro (0-< 30 ml/min).
English: Thromboembolic Events
Slovenian: Tromboembolični dogodki
English: Praxbind is for single-use only and does not contain preservatives.
Slovenian: Zdravilo Praxbind je namenjeno samo za enkratno uporabo in ne vsebuje konzervansov.
English: • patients require a second emergency surgery/urgent procedure and have prolonged clotting times.
Slovenian: • če bolniki ponovno potrebujejo nujno operacijo/nujni poseg in imajo podaljšan čas strjevanja krvi.
English: Once opened, Praxbind is intended for immediate use.
Slovenian: Odprto zdravilo Praxbind je za takojšnjo uporabo.
English: 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).
Slovenian: Reprezentativne vrednosti za farmakokinetične in farmakodinamične parametre so določili na podlagi zdravih preizkušancev, starih od 45 do 64 let, ki so dobili 5 g idarucizumaba (glejte poglavji 5.1 in 5.2).
English: Prior to use, the unopened vial may be kept at room temperature (up to 30°C) for up to 48 hours, if stored in the original package in order to protect from light.
Slovenian: Pred uporabo lahko neodprto vialo hranite pri sobni temperaturi (do 30 °C) do 48 ur, če jo shranjujete v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature.
Slovenian: Kemična in fizikalna stabilnost idarucizumaba po odprtju viale sta bili dokazani za 6 ur pri sobni temperaturi.
English: No other infusion should be administered in parallel via the same intravenous access.
Slovenian: Skozi isti intravenski dostop sočasno ni dovoljeno dajati drugih infuzij.
English: The idarucizumab-dabigatran complex is characterised by a rapid on-rate and extremely slow off-rate resulting in a very stable complex.
Slovenian: Za kompleks idarucizumab-dabigatran sta značilna hiter nastanek in izjemno počasen razpad, zaradi česar je zelo stabilen.
English: 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.
Slovenian: Izvedli so tri randomizirane, dvojno slepe, s placebom nadzorovane študije I. faze z 283 osebami (224 zdravljenimi z idarucizumabom), da bi ocenili varnost, učinkovitost, prenašanje, farmakokinetiko in farmakodinamiko idarucizumaba, bodisi uporabljenega samega ali po dajanju dabigatran eteksilata.
English: There is no information on the use of Praxbind in children.
Slovenian: Ni podatkov o uporabi zdravila Praxbind pri otrocih.
English: 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.
Slovenian: Iz zdravljenja izvirajoča možna perzistentna protitelesa proti idarucizumabu z majhnimi titri so opazili pri 4 % (10/224) preizkušancev v preskušanju I. faze in 1,6 % (8/501) bolnikov, kar kaže na majhen imunogeni potencial idarucizumaba.
English: What you need to know when you receive Praxbind
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Praxbind
English: 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.
Slovenian: Pri večini bolnikov, tako v skupini A kot B, je prišlo do popolnega izničenja antikoagulacijskega učinka dabigatrana (dTT: 98,7 %, EKT: 82,2 %, aPTČ: 92,5 % bolnikov, ki jih je bilo mogoče oceniti) v prvih 4 urah po dajanju idarucizumaba po 5 g. Učinek izničenja je bil zaznaven takoj po uporabi.
English: It will not reverse the effects of other anticoagulants.
Slovenian: Ne izniči učinkov drugih antikoagulantov.
English: 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.
Slovenian: Serumske vzorce 283 preizkušancev v preskušanjih I. faze (224 prostovoljcev, zdravljenih z idarucizumabom) in 501 bolnika so testirali za protitelesa na idarucizumab pred zdravljenjem in po njem.