natgillin/translations-raw huggingface dataset:
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
No impact on the pharmacokinetics or the reversal effect of idarucizumab or hypersensitivity reactions were observed. 
Utjecaj na farmakokinetiku ili poništenje učinka idarucizumaba ili reakcije preosjetljivosti nisu zapažene.
The transient proteinuria is a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously. 
Prolazna proteinurija je fiziološka reakcija na pretjerani priljev (engl. overflow) proteina bubrezima nakon bolusa/kratkotrajne intravenske primjene 5 g idarucizumaba.
The idarucizumab-dabigatran complex is characterised by a rapid on-rate and extremely slow off-rate resulting in a very stable complex. 
Kompleks idarucizumaba i dabigatrana karakteriziran je brzim vezivanjem i izuzetno sporim otpuštanjem, što rezultira vrlo stabilnim kompleksom.
Dosage and adminstration: 
Doziranje i primjena:
Until now, no side effects have been indentified. 
Dosad još nisu utvrđene nuspojave.
None of the patients re-dosed with idarucizumab tested positive for anti-idarucizumab antibodies. 
Niti jedan od tih bolesnika koji su ponovno primili dozu idarucizumaba nije imao pozitivan nalaz antitijela na idarucizumab.
- The other ingredients are sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20 and water for injection. 
- Drugi sastojci su natrijev acetat trihidrat, acetatna kiselina, sorbitol, polisorbat 20 i voda za injekcije.
There are no data for the use of Praxbind in pregnant women. 
Nema podataka o primjeni Praxbinda u trudnica.
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. 
Farmakodinamika idarucizumaba nakon primjene dabigatraneteksilata ispitana je u 141 dobrovoljca u ispitivanjima faze I, od kojih su predstavljeni podaci za reprezentativnu podskupinu od 6 zdravih ispitanika u dobi od 45 do 64 godina koji su primili dozu od 5 g u obliku intravenske infuzije.
No dose adjustment is required in renally impaired patients. 
Nije potrebna prilagodba doze u bolesnika s oštećenjem bubrega.
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. 
Farmakokinetika idarucizumaba ispitivana je u 224 osoba u fazi I, od kojih su prikazani podaci za reprezentativnu podskupinu od 6 zdravih ispitanika u dobi od 45 do 64 godina, a koji su primili dozu od 5 g u obliku intravenske infuzije.
• Intravenous administration as two consecutive infusions over 5 to 10 min each or as bolus injections 
• Intravenska primjena u obliku dvije uzastopne infuzije tijekom 5 do 10 minuta svaka ili u obliku bolus injekcija.
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. 
Nakon primjene Praxbinda, u svakom trenutku se može početi s drugom antitrombotskom terapijom (npr. heparinom niske molekulske mase), ako je bolesnik klinički stabilan te je postignuta odgovarajuća hemostaza.
Renal impairment did not impact the reversal effect of idarucizumab (see section 5.2). 
Oštećenje bubrega nije utjecalo na antagonistički učinak idarucizumaba (vidjeti dio 5.2).
Praxbind (2x2.5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection. 
Praxbind (2 x 2,5 g/50 ml) se primjenjuje intravenski u obliku dvije konsekutivne infuzije tijekom 5 do 10 minuta svaka ili u obliku bolus injekcije.
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. 
Liječenje Pradaxom (dabigatraneteksilatom) može se ponovo započeti 24 sata nakon primjene Praxbinda, ako je bolesnik klinički stabilan te je postignuta odgovarajuća hemostaza.
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena formalna ispitivanja interakcija Praxbinda i drugih lijekova.
Clear to slightly opalescent, colourless to slightly yellow solution. 
Bistra do blago zamućena, bezbojna do blago žuta otopina.
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). 
Primarna mjera ishoda je bila maksimalni postotak poništenja antikoagulacijskog učinka dabigatrana unutar 4 sata nakon primjene idarucizumaba na temelju razrijeđenog trombinskog vremena (dTT) ili ekarinskog vremena zgrušavanja određenih u središnjem laboratoriju.
Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) (see section 5.1). 
Relevatni parametri koagulacije su aktivirano parcijalno tromboplastinsko vrijeme (aPTT), razrijeđeno trombinsko vrijeme (dTT) ili ekarinsko vrijeme zgrušavanja (ECT) (vidjeti dio 5.1).
PHARMACEUTICAL FORM AND CONTENTS solution for injection/infusion 2 vials of 50 mL each 
OBLIK I SADRŽAJ otopina za injekciju/infuziju 2 bočice od 50 ml svaka
Your doctor will continue treating you with medicines used to prevent the formation of blood clots as soon as your medical condition allows. 
Čim Vaše medicinsko stanje dopusti, liječnik će Vas nastaviti liječiti lijekovima koji se koriste za sprječavanje stvaranja krvnih ugrušaka.
• The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL) 
• Preporučena doza Praxbinda je 5 g (2 x 2,5 g/50 ml).
Praxbind binds specifically to dabigatran and reverses its anticoagulant effect. 
Praxbind se specifično veže za dabigatran i poništava njegov antikoagulacijski učinak.
LIST OF EXCIPIENTS Excipients: Sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20, water for injection. 
POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev acetat trihidrat, acetatna kiselina, sorbitol, polisorbat 20, voda za injekcije.
The recommended dose is 5 g (2 vials of 50 mL). 
Preporučena doza je 5 g (2 bočice od 50 ml).
PHARMACEUTICAL FORM AND CONTENTS 2 vials of 50 mL solution for injection/infusion each 
OBLIK I SADRŽAJ 2 bočice od 50 ml otopine za injekciju/infuziju svaka
After treatment with idarucizumab proteinuria has been observed. 
Nakon liječenja idarucizumabom uočena je proteinurija.
Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises their anticoagulant effect. 
Idarucizumab se potentno i specifično veže za dabigatran i njegove metabolite te neutralizira njihov antikoagulacijski učinak.
In one subject, treatment-emergent anti-idarucizumab antibodies were detected after the second administration. 
U jednog ispitanika nakon druge primjene otkrivena su antitijela na idarucizumab nastala tijekom liječenja.
Figure 4 - Plasma-levels of unbound dabigatran in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h) 
Slika 4 - plazmatske razine nevezanog dabigatrana u reprezentativnoj skupini zdravih ispitanika (primjena idarucizumaba ili placeba pri 0 h)
The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL). 
Preporučena doza Praxbinda je 5 g (2 x 2,5 g/50 ml).
They will take this into account before treating you with Praxbind. 
Oni će to uzeti u obzir prije no što Vas liječe Praxbindom.
It is unknown whether idarucizumab is excreted in human milk. 
Nije poznato izlučuje li se idarucizumab u majčino mlijeko u ljudi.
Relevant coagulation parameters are activated Partial Thromboplastin Time (aPTT), diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT). 
Relevatni parametri koagulacije su aktivirano parcijalno tromboplastinsko vrijeme (aPTT), razrijeđeno trombinsko vrijeme (dTT) ili ekarinsko vrijeme zgrušavanja (ECT).
Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration. 
Lijekove za parenteralnu primjenu poput Praxbinda potrebno je prije primjene vizualno pregledati na prisutnost čestičnih tvari i promjene boje.
Each vial contains 2.5 g idarucizumab in 50 mL. 
Jedna bočica sadrži 2,5 g idarucizumaba u 50 ml.
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) 
Slika 5 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog testom dTT u reprezentativnoj skupini zdravih ispitanika (primjena idarucizumaba ili placeba pri 0 h)
Figure 3 - Reversal of dabigatran-induced clotting time prolongation determined by aPTT in patients from the RE-VERSE AD study (N=486) 
Slika 3 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog testom aPTT u bolesnika iz ispitivanja RE-VERSE AD (N=486)
NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion 
NAZIV LIJEKA Praxbind 2,5 g/50 ml otopina za injekciju/infuziju
No local irritation of the blood vessel was observed after i.v. 
Nije zapažena lokalna iritacija krvne žile nakon intravenske ili paravenske primjene idarucizumaba.
Package leaflet: Information for the patient and user Praxbind 2.5 g/50 mL solution for injection/infusion idarucizumab 
Uputa o lijeku: Informacije za bolesnika Praxbind 2,5 g/50 ml otopina za injekciju/infuziju idarucizumab
Figure 1 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in patients from the RE-VERSE AD study (N=487) 
Slika 1 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog testom dTT u bolesnika iz ispitivanja RE-VERSE AD (N=487)
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. 
Ovisno o stupnju oštećenja bubrega ukupni klirens se smanjio u usporedbi sa zdravim ispitanicima, što je dovelo do povećane izloženosti idarucizumabu.
Preclinical pharmacodynamics 
Pretklinička farmakodinamika
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) 
Slika 6 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog testom ECT u reprezentativnoj skupini zdravih ispitanika (primjena idarucizumaba ili placeba pri 0 h)
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 50 mL contains 2.5 g idarucizumab. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 50 ml sadrži 2,5 g idarucizumaba.
Idarucizumab alone has shown no procoagulant effect measured as ETP. 
Idarucizumab u obliku monoterapije nije pokazao prokoagulantni učinak mjeren kao ETP, što ukazuje da idarucizumab nema protrombotski učinak.
Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. 
Poništenje terapije dabigatranom izlaže bolesnike riziku od tromboze u njihovoj osnovnoj bolesti ili stanju.
All pigs survived at idarucizumab doses of approximately 2.5 and 5 g. Without idarucizumab, the mortality in the anticoagulated group was 100 %. 
Sve svinje su preživjele pri dozama idarucizumaba od približno 2,5 i 5 g.
NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion Idarucizumab 
Praxbind 2,5 g/50 ml otopine za injekciju/infuziju idarucizumab
Figure 2 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in patients from the RE-VERSE AD study (N=487) 
Slika 2 - poništenje produljenja vremena zgrušavanja induciranog dabigatranom utvrđenog ekarinskim vremenom zgrušavanja u bolesnika iz ispitivanja RE-VERSE AD (N=487)
Idarucizumab is a specific reversal agent for dabigatran. 
Idarucizumab je specifičan antagonist dabigatrana.
Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect. 
Idarucizumab se specifično veže za dabigatran i poništava njegov antikoagulacijski učinak.
Nine patients were re-dosed with idarucizumab. 
Devet bolesnika ponovno je primilo dozu idarucizumaba.
-1 Porcine circovirus type 2 ORF2 subunit antigen: ≥ 1,436 AU* per 0.2 ml * Antigenic units as determined in the in vitro potency test (antigenic mass assay). 
--1 Porcin cirkovirus tip 2 ORF2 subjedinica antigena ≥ 1,436 AU* za 0,2 ml * Jedinice antigena određene in vitro testom potencije ( test mase antigena ).
Content Package size 
Način primjene Pakovanje Sadržaj Veličina pakovanja
The subgroups in these studies were too small to draw reliable conclusions. 
Podskupine u tim ispitivanjima bile su premale da bi se izvukli pouzdani zaključci.
Then take the next capsule at the usual time. 
Zatim uzmite sljedeću kapsulu u uobičajeno vrijeme.
• Take the capsule once in the morning and once in the evening. 
• Uzmite jednu kapsulu ujutro i jednu navečer.
Effect on other transport proteins 
Učinak na druge transportne proteine
• Take the capsules at about the same time each day. 
• Uzimajte kapsule svakoga dana približno u isto vrijeme.
Body Weight and Gender 
Tjelesna težina i spol
They may be taken with or without food. 
Mogu se uzimati s hranom ili bez nje.
Fifty percent of objective tumour responses were achieved during the first 8 weeks of treatment. 
Pedeset posto objektivnih tumorskih odgovora postignuto je tijekom prvih 8 tjedana liječenja.