FrancophonIA/ELRC3.0 huggingface dataset:
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 %).
Croatian: Nakon intravenske infuzije doze od 5 g, geometrijski srednji volumen distribucije pri stanju dinamičke ravnoteže (Vss) bio je 8,9 l (geometrijski koeficijent varijacije (gCV) 24,8%).
English: Administration of a second 5 g dose of Praxbind may be considered in the following situations:
Croatian: Primjena druge doze Praxbinda od 5 g može se razmotriti u sljedećim situacijama:
English: This medicine is for hospital use only.
Croatian: Ovaj lijek je samo za bolničku primjenu.
English: 61.5% of patients in Group A and 62.4% of patients in Group B had been treated with dabigatran 110 mg twice daily.
Croatian: 61,5% bolesnika u skupini A te 62,4% bolesnika u skupini B liječeno je dabigatranom 110 mg dvaput dnevno.
English: The idarucizumab formulation did not produce haemolysis of human whole blood in vitro.
Croatian: Formulacija idarucizumaba nije dovela do hemolize humane pune krvi in vitro.
English: Praxbind must not be mixed with other medicinal products.
Croatian: Praxbind se ne smije miješati s drugim lijekovima.
English: Idarucizumab is produced by recombinant DNA technology in Chinese Hamster Ovary cells.
Croatian: Idarucizumab je proizveden tehnologijom rekombinantne DNK u stanicama jajnika kineskog hrčka.
English: This medicine contains 50 mg sodium (main component of cooking/table salt) per dose.
Croatian: Ovaj lijek sadrži 50 mg natrija (glavnog sastojka kuhinjske soli) po dozi.
English: In Phase I studies Praxbind has been investigated in subjects with a creatinine clearance ranging from 44 to 213 mL/min.
Croatian: U ispitivanjima faze I Praxbind se ispitivao u osoba s klirensom kreatinina u rasponu od 44 do 213 ml/min.
English: For storage conditions after opening of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon prvog otvaranja lijeka vidjeti u dijelu 6.3.
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.
Croatian: Na temelju ovih podataka i opsega antikoagulacijskog učinka dabigatrana u bolesnika, oštećenje bubrega ne utječe na antagonistički učinak idarucizumaba.
English: Pradaxa can be given again 24 hours after Praxbind administration.
Croatian: Pradaxa se može ponovo dati 24 sata nakon primjene Praxbinda.
English: Praxbind is for single-use only and does not contain preservatives.
Croatian: Praxbind je namijenjen samo za jednokratnu uporabu i ne sadrži konzervanse.
English: This medicine will only remove dabigatran from your body.
Croatian: Ovaj lijek će iz Vašeg tijela ukloniti samo dabigatran.
English: Tell your doctor, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
English: Based on population pharmacokinetic analyses, sex, age, and race do not have a clinically meaningful effect on the pharmacokinetics of idarucizumab.
Croatian: Na osnovi farmakokinetičkih analiza populacije, spol, dob i rasa nemaju klinički značajan učinak na farmakokinetiku idarucizumaba.
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.
Croatian: U bolesnika s nasljednom nepodnošljivošću fruktoze parenteralna primjena sorbitola je povezana s prijavljenim slučajevima hipoglikemije, hipofosfatemije, metaboličke acidoze, povećanja mokraćne kiseline, akutnog zatajenja jetre s prekidom ekskretorne i sintetske funkcije, kao i smrti.
English: This occurred 1-24 hours after administration of idarucizumab mainly at timepoints ≥12 hours.
Croatian: To se javilo 1-24 sata nakon primjene idarucizumaba uglavnom na vremenskim točkama ≥ 12 sati.
English: There is no information on the effects of this medicine in pregnant or breast-feeding women.
Croatian: Nema podataka o učincima ovog lijeka u trudnica ili dojilja.
English: The transient proteinuria is not indicative of renal damage, which should be taken into account for urine testing.
Croatian: Prolazna proteinurija ne upućuje na oštećenje bubrega što treba uzeti u obzir pri pretrazi urina.
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).
Croatian: 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).
English: This medicine has been designed to only bind to dabigatran.
Croatian: Ovaj lijek je razvijen samo u svrhu vezanja za dabigatran.
English: Hereditary fructose intolerance
Croatian: Nasljedna nepodnošljivost fruktoze
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.
Croatian: 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.
English: 88397 Biberach an der Riss GERMANY
Croatian: 88397 Biberach an der Riss NJEMAČKA
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate (see section 4.2).
Croatian: Radi smanjenja ovog rizika, potrebno je razmotriti nastavljanje terapije antikoagulansom čim je to medicinski prikladno (vidjeti dio 4.2).
English: 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.
Croatian: Doze idarucizumaba u ovim ispitivanjima varirale su od 20 mg do 8 g, a trajanje infuzije od 5 minuta do 1 sata.
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 %).
Croatian: 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%).
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.
Croatian: 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.
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.
Croatian: 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.
English: Studies to assess the potential reproductive effects of idarucizumab have not been performed.
Croatian: Ispitivanja u svrhu ocjene potencijalnih učinaka idarucizumaba na reprodukciju nisu provedena.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Praxbind should be discontinued immediately and appropriate therapy initiated.
Croatian: Ako se pojavi anafilaktička reakcija ili druga ozbiljna alergijska reakcija, potrebno je odmah prekinuti primjenu Praxbinda i započeti odgovarajuću terapiju.
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.
Croatian: 50 ml otopine u staklenoj bočici (staklo tipa I) sa čepom od butilne gume, aluminijskim zatvaračem i naljepnicom s integriranom vješalicom.
English: Thromboembolic Events
Croatian: Tromboembolički događaji
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 4.9 Overdose
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
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.
Croatian: 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.
English: • if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or
Croatian: • ako bi potencijalno ponovno krvarenje bilo po život opasno, a opažena su produljena vremena zgrušavanja ili
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.
Croatian: 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.
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.
Croatian: Praxbind je antagonist specifičan za dabigatran (Pradaxu), lijek za razrjeđivanje krvi koji blokira tvar u tijelu uključenu u stvaranje krvnog ugruška.
English: After you have received Praxbind, your doctor will decide on the continuation of your treatment to prevent blood clot formation.
Croatian: Nakon što ste primili Praxbind, Vaš će liječnik odlučiti o nastavljanju liječenja radi sprječavanja stvaranja krvnih ugrušaka.
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.
Croatian: 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.
English: After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature.
Croatian: Nakon otvaranja bočice, kemijska i fizikalna stabilnost idarucizumaba tijekom uporabe pokazana je za 6 sati na sobnoj temperaturi.
English: Idarucizumab exhibited multiphasic disposition kinetics and limited extravascular distribution.
Croatian: Idarucizumab je pokazao kinetiku dispozicije u više faza i ograničenu ekstravaskularnu distribuciju.
English: No dose adjustment is required in elderly patients aged 65 years and above (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika starijih od 65 godina (vidjeti dio 5.2).
English: D-88397 Biberach an der Riss Germany
Croatian: D-88397 Biberach an der Riss Njemačka
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).
Croatian: 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).
English: • recurrence of clinically relevant bleeding together with prolonged clotting times, or
Croatian: • ponovna pojava klinički značajnog krvarenja zajedno s produljenim vremenom zgrušavanja ili
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SKLOPIVA KUTIJA
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.
Croatian: Odmah nakon primjene idarucizumaba, koncentracije nevezanog dabigatrana u plazmi smanjile su se za više od 99%, što je rezultiralo razinama bez antikoagulacijske aktivnosti.
English: Additionally, no idarucizumab binding to human reproductive tissues was observed in a tissue cross-reactivity study.
Croatian: Pored toga, vezanje idarucizumaba na humana reproduktivna tkiva nije zapaženo u ispitivanju tkivne križne reaktivnosti.
English: Each 50 mL vial contains 2 g sorbitol and 25 mg sodium (see section 4.4).
Croatian: Jedna bočica od 50 ml sadrži 2 g sorbitola i 25 mg natrija (vidjeti dio 4.4).
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.
Croatian: 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.
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.
Croatian: 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.
English: These tests were used to assess the anticoagulant effect of dabigatran.
Croatian: Ove su se pretrage koristile za procjenu antikoagulacijskog učinka dabigatrana.
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.
Croatian: 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.
English: Preclinical investigations with idarucizumab have shown no interactions with
Croatian: Pretklinička istraživanja idarucizumaba nisu pokazala interakcije s
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.
Croatian: 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.
English: Since dabigatran is also excreted primarily via the kidneys, increases in the exposure to dabigatran are also seen with worsening renal function.
Croatian: Budući da se dabigatran također izlučuje primarno putem bubrega, povećanja u izloženosti dabigatranu zapažena su i u bolesnika s pogoršanom funkcijom bubrega.
English: What Praxbind is and what it is used for
Croatian: Što je Praxbind i za što se koristi
English: Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „EXP“.
English: Praxbind contains sodium
Croatian: Praxbind sadrži natrij
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.
Croatian: Linija se prije i nakon završetka infuzije mora isprati otopinom natrijeva klorida od 9 mg/ml (0,9%) za injekciju.
English: It will not reverse the effects of other anticoagulants.
Croatian: On neće poništiti učinke drugih antikoagulanasa.
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.
Croatian: Radi smanjenja ovog rizika, potrebno je razmotriti nastavljanje terapije antikoagulansom čim je to medicinski prikladno.
English: Idarucizumab has been studied in 58 patients with varying degrees of hepatic impairment.
Croatian: Idarucizumab je ispitan u 58 bolesnika s raznim stupnjevima oštećenja jetre.
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.
Croatian: 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.
English: A value in the normal range after administration of idarucizumab indicates that a patient is no longer anticoagulated.
Croatian: Vrijednost u normalnom rasponu nakon primjene idarucizumaba upućuje da bolesnik više nije antikoaguliran.
English: The transient proteinuria usually peaked about 4 h after idarucizumab administration and normalised within 12-24 hours.
Croatian: Prolazna proteinurija je obično dosegnula vršne vrijednosti oko 4 sata nakon primjene idarucizumaba, a normalizirala se unutar 12-24 sata.
English: Thus idarucizumab will not reverse the effects of other anticoagulants.
Croatian: idarucizumab neće poništiti učinke drugih antikoagulanasa.
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:
Croatian: Praxbind je specifičan antagonist dabigatrana te je indiciran u odraslih bolesnika liječenih Pradaxom (dabigatraneteksilatom) kada je potrebno brzo poništenje njegovog antikoagulacijskog učinka:
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.
Croatian: 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).
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.
Croatian: 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.
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.
Croatian: 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.
English: No incompatibilities between Praxbind and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.
Croatian: Nisu zapažene inkompatibilnosti između Praxbinda i infuzijskih kompleta od polivinilklorida, polietilena ili poliuretana ili polipropilenskih štrcaljki.
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.
Croatian: 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.
English: There are no data on the effect of Praxbind on fertility (see section 5.3).
Croatian: Nema podataka o učinku Praxbinda na plodnost (vidjeti dio 5.3).
English: No anti-idarucizumab antibodies were detected in these subjects prior to the second administration.
Croatian: U ovih ispitanika nisu otkrivena antitijela na idarucizumab prije druge primjene.
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.
Croatian: Međutim u podskupini bolesnika, zamijećena je ponovna pojava plazmatskih razina nevezanog dabigatrana i prateće povišenje testova zgrušavanja, moguće uslijed redistribucije dabigatrana s periferije.
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.
Croatian: 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.
English: Pack size of 2 vials.
Croatian: Veličina pakiranja od 2 bočice.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Intravenska primjena
English: 4 factor), activated PCCs (aPCCs) and recombinant factor VIIa.
Croatian: faktor 3 i faktor 4), aktiviranim koncentratima protrombinskog kompleksa (aPPC-i) i rekombinantnim faktorom VIIa;
English: What Praxbind contains - The active substance is idarucizumab.
Croatian: Što Praxbind sadrži - Djelatna tvar je idarucizumab.
English: There is no information on the use of Praxbind in children.
Croatian: Nema informacija o primjeni Praxbinda u djece.
English: • coagulation factor concentrates, such as prothrombin complex concentrates (PCCs, e.g. 3 factor and
Croatian: • koncentratima faktora koagulacije, poput koncentrata protrombinskog kompleksa (PCC-i, npr.
English: Effect of idarucizumab on the exposure and anticoagulant activity of dabigatran
Croatian: Učinak idarucizumaba na izloženost i antikoagulacijsku aktivnost dabigatrana
English: Tell your doctor or nurse - if you are allergic to idarucizumab or to any other of the substances listed in section 6.
Croatian: 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.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection/infusion contains 50 mg idarucizumab.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine za injekciju/infuziju sadrži 50 mg idarucizumaba.
English: 6.1 List of excipients sodium acetate trihydrate acetic acid sorbitol polysorbate 20 water for injection
Croatian: 6.1 Popis pomoćnih tvari natrijev acetat trihidrat acetatna kiselina sorbitol polisorbat 20 voda za injekcije
English: Patients being treated with dabigatran have underlying disease states that predispose them to thromboembolic events.
Croatian: Bolesnici liječeni dabigatranom imaju stanja osnovnih bolesti koja ih predodređuju za tromboemboličke događaje.