FrancophonIA/ELRC3.0 huggingface dataset:
English: Name and address of the manufacturer of the biological active substance Richter-Helm BioLogics GmbH & Co. KG Dengelsberg
Croatian: Naziv i adresa proizvođača biološke djelatne tvari Richter-Helm BioLogics GmbH & Co.
English: • Clean the exposed rubber stopper using one of the alcohol pads provided and allow it to dry for a few seconds.
Croatian: • Očistite izloženi gumeni čep jednim od jastučića natopljenog alkoholom priloženim u pakiranju i pustite da se osuši par sekundi.
English: The first dose of Cablivi is to be administered as an intravenous injection.
Croatian: Prvu dozu lijeka Cablivi potrebno je primijeniti intravenskom injekcijom.
English: Instructions for healthcare professionals on how to inject Cablivi into your vein are at the end of the leaflet.
Croatian: Upute za zdravstvene radnike o tome kako injektirati Cablivi u venu nalaze se na kraju ovih uputa.
English: • multipacks each containing 7 single packs
Croatian: • višestrukim pakiranjima od kojih svaki sadrži 7 pojedinačnih pakiranja
English: Use of Cablivi in this population requires a benefit/risk assessment and close clinical monitoring.
Croatian: Primjena lijeka Cablivi kod ove populacije zahtijeva procjenu omjera koristi i rizika i strogo kliničko praćenje.
English: Take care that the adapter does not come away from the vial.
Croatian: Pazite da nastavak ne izađe iz bočice.
English: Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.
Croatian: Cablivi je indiciran za liječenje odraslih koji su doživjeli epizodu stečene trombotične trombocitopenične purpure (engl. acquired thrombotic thrombocytopenic purpura, aTTP), u kombinaciji s izmjenom plazme i imunosupresijom.
English: It must be visually inspected for particulate matter.
Croatian: Mora se vizualno pregledati kako bi se isključila prisutnost vidljivih čestica.
English: No interaction studies evaluating use of caplacizumab with oral anticoagulants (e.g. vitamin K antagonists, direct oral anticoagulants [DOAC] such as thrombin inhibitors or factor Xa inhibitors) or high dose heparin have been performed (See section 4.4 In the setting of concomitant use of oral anticoagulants or high dose heparin).
Croatian: Nisu provedena ispitivanja interakcija u kojima se procjenjuje primjena kaplacizumaba s oralnim antikoagulansima (npr. antagonisti vitamina K, izravnim oralnim antikoagulansima kao što su inhibitori trombina ili inhibitori faktora Xa) ili visokim dozama heparina (Vidjeti dio 4.4 Istodobna primjena oralnih antikoagulansa ili visoke doze heparina).
English: Subsequent doses
Croatian: Sljedeće doze
English: It is used to treat an episode of acquired thrombotic thrombocytopenic purpura in adults.
Croatian: Upotrebljava se za liječenje epizode stečene trombotične trombocitopenične purpure u odraslih.
English: • Make sure you have a disposal container at hand.
Croatian: • Imajte spremnik za odlaganje pri ruci.
English: Caplacizumab
Croatian: Placebo Kaplacizumab
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mL water for injections
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 ml vode za injekcije
English: Caplacizumab is a humanised bivalent Nanobody that consists of two identical humanised building blocks (PMP12A2hum1), genetically linked by a three-alanine linker, targeting the A1-domain of von Willebrand factor and inhibiting the interaction between von Willebrand factor and platelets.
Croatian: Kaplacizumab je humanizirano bivalentno nanotijelo koje se sastoji od dvije identične humanizirane gradivne sastavnice (PMP12A2hum1) genetski povezane trialaninskom vezom, a koje cilja domenu A1 von Willebrandovog faktora i inhibira interakciju između von Willebrandovog faktora i trombocita.
English: In this study, 145 patients experiencing an episode of aTTP were randomised (72 to caplacizumab and to 73 placebo).
Croatian: U ovom je ispitivanju randomizirano 145 bolesnika koji su doživjeli epizodu aTTP-a (72 za kaplacizumab i 73 za placebo).
English: Do not return Cablivi to refrigerated storage after storage at room temperature.
Croatian: Cablivi na čuvanje u hladnjaku nakon čuvanja na sobnoj temperaturi.
English: Epistaxis*
Croatian: Epistaksa*
English: If a recurrence occurred while on study drug treatment, patients were switched to open-label caplacizumab.
Croatian: Ako se bolest ponovila tijekom razdoblja liječenja ispitivanim lijekom, bolesnici su prebačeni u otvoreno liječenje kaplacizumabom.
English: In this double-blind, placebo-controlled study, patients with an episode of aTTP were randomised 1:1 to receive either caplacizumab or placebo in addition to daily plasma exchange and immunosuppression.
Croatian: U ovom dvostruko slijepom, placebom kontroliranom ispitivanju, bolesnici s epizodama aTTP-a randomizirani su 1:1 za primanje kaplacizumaba ili placeba nastavno na dnevnu izmjenu plazme i imunosupresiju.
English: • Select a suitable place (‘injection site') on your belly for injection under your skin.Avoid the area around the belly button.
Croatian: • Odaberite odgovarajuće mjesto („mjesto injekcije“) na trbuhu za primjenu potkožne injekcije.
English: • After cleaning, do not touch the rubber stopper or allow it to touch any surface.
Croatian: • Nakon čišćenja nemojte dodirivati gumeni čep niti dodirivati s njim druge površine.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Multipack: 7 packs of 1 single dose kit.
Croatian: OBLIK I SADRŽAJ Prašak i otapalo za otopinu za injekciju Višestruko pakiranje: 7 jednodoznih setova u pojedinačnom pakiranju
English: If needed, the use of von Willebrand Factor concentrate could be considered to correct hemostasis.
Croatian: Ako je potrebno, može se razmotriti primjena koncentrata von Willebrandovog faktora radi korekcije hemostaze.
English: The pharmacokinetics of caplacizumab have been investigated in healthy subjects after single intravenous infusions and after single and repeated subcutaneous injections.
Croatian: Farmakokinetika kaplacizumaba ispitivana je u zdravih ispitanika nakon jedne intravenske infuzije i nakon jedne i ponovljenih supkutanih injekcija.
English: Also tell your doctor if you are using an anticoagulant medicine such as vitamin K antagonists, rivaroxaban, or apixaban which treat blood clots or anti-platelet agents, such as aspirin, or low molecular weight heparin which prevent blood clots.
Croatian: Također recite svom liječniku ako uzimate antikoagulanse kao što su antagonisti vitamina K, rivaroksaban ili apiksaban koji se koriste za liječenje krvnih ugrušaka ili antitrombocitne lijekove kao što su acetilsalicilatna kiselina ili niskomolekularni heparin za sprječavanje stvaranja krvnih ugrušaka.
English: Your doctor will advise you whether to discontinue breastfeeding or not use Cablivi, considering the benefit of breastfeeding to the baby and the benefit of Cablivi to you.
Croatian: Vaš liječnik će vas savjetovati trebate li prekinuti dojenje ili prestati primjenjivati Cablivi, uzevši pritom u obzir korist dojenja za dijete i korist liječenja lijekom Cablivi za vas.
English: • Multipack containing 7 single packs.
Croatian: • Višestruko pakiranje sadrži 7 pojedinačnih pakiranja.
English: Menorrhagia*, vaginal haemorrhage*
Croatian: Menoragija*, vaginalno krvarenje*
English: The pharmacokinetics of caplacizumab were determined using a population pharmacokinetic analysis on pooled pharmacokinetic data.
Croatian: Farmakokinetika kaplacizumaba je određena pomoću populacijske farmakokinetičke analize na objedinjenim farmakokinetičkim podacima.
English: The effects of caplacizumab on fertility in humans are unknown.
Croatian: Utjecaj kaplacizumaba na plodnost kod ljudi nije poznat.
English: • Turn the whole - vial, adapter and syringe - right-side up (with the syringe at the top).
Croatian: • Okrenite sve zajedno - bočicu s nastavkom i štrcaljkom - ravno prema gore (sa štrcaljkom na vrhu).
English: Your doctor may decide to keep you under closer observation or change your treatment.
Croatian: Vas pod strogim nadzorom ili Vam promijeniti liječenje.
English: • Remove the plastic packaging from the adapter by holding the vial with one hand, pressing the sides of the adapter packaging with your other hand, and then lifting the packaging upwards.
Croatian: • Uklonite plastično pakiranje s nastavka tako da držite bočicu jednom rukom, a drugom rukom pritisnete s obje strane pakiranja nastavka a zatim povučete pakiranje prema gore.
English: No formal study with caplacizumab has been conducted in patients with severe acute or chronic hepatic impairment and no data regarding the use of caplacizumab in these populations are available.
Croatian: Nisu provedena službena ispitivanja s lijekom kaplacizumab kod bolesnika s teškim akutnim ili kroničnim oštećenjem jetre i nema dostupnih podataka o primjeni kaplacizumaba kod tih bolesnika.
English: The intravenous bolus injection of Cablivi given at the start of the treatment must be administered by a health care professional.
Croatian: Intravensku bolus injekciju lijeka Cablivi na početku liječenja mora primijeniti zdravstveni radnik.
English: In repeat-dose toxicity tests in cynomolgus monkeys, no impact of caplacizumab on fertility parameters in male (testicular size, sperm function, histopathological analysis of testis and epididymis) and female (histopathological analysis of reproductive organs, periodic vaginal cytology) animals was observed.
Croatian: U ispitivanjima toksičnosti ponovljenih doza kod makaki majmuna nije uočen utjecaj kaplacizumaba na parametre plodnosti u mužjaka (veličina testisa, funkcija spermija, histopatološka analiza testisa i epididimisa) i ženki (histopatološka analiza reproduktivnih organa, periodična vaginalna citologija).
English: Upon repeated administration of caplacizumab, a decrease of 30-50% in von Willebrand factor antigen levels was observed in clinical studies, reaching a maximum within 1-2 days of treatment.
Croatian: Nakon ponovljene primjene kaplacizumaba, u ispitivanjima je uočeno smanjenje razina antigena von Willebrandovog faktora za 30-50%, a maksimum je dosegnut unutar 1-2 dana liječenja.
English: No data on re-treatment with caplacizumab are available.
Croatian: Nema dostupnih podataka o ponovnom liječenju kaplacizumabom.
English: • water for injections in a pre-filled syringe to dissolve the powder After dissolving the powder in the solvent, the solution is clear, colourless or slightly yellowish.
Croatian: • voda za injekcije u napunjenoj štrcaljki za otapanje praška Nakon otapanja praška u otapalu, otopina je prozirna, bezbojna ili blago žućkaste boje.
English: Do not shake it.
Croatian: Nemojte tresti.
English: Baseline disease characteristics were typical of aTTP.
Croatian: Karakteristike bolesti na početku ispitivanja bile su tipične za aTTP.
English: Due to a potential increased risk of bleeding, use of Cablivi in patients with underlying coagulopathies (e.g. hemophilia, other coagulation factor deficiencies) is to be accompanied by close clinical monitoring.
Croatian: Zbog potencijalno povećanog rizika od krvarenja, primjena lijeka Cablivi kod bolesnika s podležećim koagulopatijama (npr. hemofilija, drugi nedostaci faktora koagulacije) mora se provoditi pod strogim kliničkim praćenjem.
English: Treatment with caplacizumab resulted in a 74% reduction in the composite endpoint of the percentage of patients with aTTP-related death (0/72; placebo 3/73), exacerbation of aTTP (3/72; placebo 28/73), or at least one major thromboembolic event during study drug treatment (6/72; placebo 6/73) (p<0.0001).
Croatian: Liječenje kaplacizumabom rezultiralo je 74%-tnim smanjenjem kompozitne mjere ishoda koja se sastoji od postotka bolesnika sa smrtnim ishodom povezanim s aTTP-om (0/72; placebo 3/73), pogoršanjem aTTP-a (3/72; placebo 28/73) ili barem jednim velikim tromboembolijskim događajem tijekom liječenja ispitivanim lijekom (6/72; placebo 6/73) (p<0,0001).
English: Treatment with caplacizumab reduced the mean number of days of plasma exchange, the volume of plasma used, the mean length of Intensive Care Unit stay and the mean length of hospitalization during the study drug treatment period.
Croatian: Liječenje kaplacizumabom rezultiralo je smanjenjem prosječnog broja dana primjene izmjene plazme, korištenog volumena plazme, prosječnog trajanja boravka na odjelu za intenzivnu njegu i prosječnog trajanja hospitalizacije tijekom razdoblja liječenja ispitivanim lijekom.
English: • Pull back the needle safety shield.
Croatian: • Povucite prema natrag sigurnosnu zaštitu igle.
English: What Cablivi looks like and contents of the pack
Croatian: Kako Cablivi izgleda i sadržaj pakiranja Cablivi sadrži:
English: • Take the packed vial adapter and remove the paper cover.
Croatian: • Uzmite pakiranje nastavka za bočicu i uklonite papirni pokrov.
English: • Remove any air bubbles by tapping the side of the syringe with your finger to make the bubbles rise towards the tip.
Croatian: • Uklonite mjehuriće zraka tako što ćete prstom kucnuti štrcaljku sa strane kako bi se mjehurići popeli na vrh.
English: By doing so, Cablivi reduces the risk of experiencing another episode of aTTP soon after the first.
Croatian: Cablivi smanjuje rizik da se druga epizoda trombotične trombocitopenične purpure (aTTP)-a pojavi ubrzo nakon prve.
English: Do not use Cablivi if you notice any particulate matter or discolouration prior to administration.
Croatian: Nemojte primijeniti Cablivi ako uočite vidljive čestice ili promjenu boje prije primjene.
English: No patients treated with caplacizumab (0/72) were refractory to treatment (defined as absence of platelet count doubling after 4 days of standard treatment and elevated LDH) compared to three patients treated with placebo (3/73).
Croatian: Niti jedan bolesnik liječen kaplacizumabom (0/72) nije bio rezistentan na liječenje (definirano kao odsustvo udvostručenja broja trombocita nakon 4 dana standardnog liječenja i povišenog LDH) u usporedbi s tri bolesnika liječena placebom (3/73).
English: Consistent with its mode of action, toxicology studies of caplacizumab have shown an increased bleeding tendency in guinea pigs (haemorrhagic subcutaneous tissue at the injection sites) and cynomolgus monkeys (haemorrhagic subcutaneous tissue at the injection sites, nose bleed, exaggerated menstrual bleeding, haematoma at sites of animal handling or experimental procedures, prolonged bleeding at injection sites).
Croatian: Sukladno mehanizmu djelovanja, u toksikološkim ispitivanjima kaplacizumaba zamijećena je povećana sklonost krvarenju kod zamoraca (hemoragično supkutano tkivo na mjestima primjene) i makaki majmuna (hemoragično supkutano tkivo na mjestima primjene, krvarenje iz nosa, pretjerano menstrualno krvarenje, hematom na mjestu hvata kod životinja ili eksperimentalnih postupaka, produljeno krvarenje na mjestima primjene).
English: Vial (type I glass) with a stopper (butyl rubber), a seal (aluminium) and a cap (polypropylene), containing 10 mg of caplacizumab.
Croatian: Bočica (staklo tip I) s čepom (butil guma), prstenom (aluminij) i kapicom (polipropilen) koja sadrži 10 mg kaplacizumaba.
English: • Allow the vial with connected syringe to stand on the surface for 5 minutes at room temperature to allow the solution to completely dissolve.
Croatian: • Ostavite bočicu s pričvršćenom štrcaljkom 5 minuta na sobnoj temperaturi kako bi omogućili potpuno otapanje lijeka.
English: Pyrexia, Fatigue
Croatian: Pireksija, umor
English: • if you are allergic to caplacizumab or any of the other ingredients in this medicine (listed in section 6)
Croatian: Nemojte primjenjivati Cablivi • ako ste alergični na kaplacizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • are using anticoagulants such as vitamin K antagonists , rivaroxaban, apixaban (which treat blood clots).
Croatian: • uzimatete antikoagulanse kao što su antagonisti vitamina K, rivaroksaban, apiksaban (za liječenje ugrušaka).
English: Pharmacokinetics in patients with aTTP were investigated upon single intravenous and repeated subcutaneous injections.
Croatian: Farmakokinetika u bolesnika s aTTP-om ispitivana je nakon jedne intravenske injekcije i ponovljenih supkutanih injekcija.
English: Allow the vial with connected syringe to stand on a surface for 5 minutes at room temperature.
Croatian: Ostavite bočicu s postavljenom štrcaljkom da odstoji 5 minuta na sobnoj temperaturi.
English: • Slowly push the syringe's plunger down until the syringe is empty.
Croatian: • Lagano gurnite klip štrcaljke prema dolje sve dok se štrcaljka ne isprazni.
English: There are no data on the use of caplacizumab in pregnant women.
Croatian: Nema dostupnih podataka o primjeni kaplacizumaba kod trudnica.
English: • Unpack the needle by tearing the paper cover off the needle packaging and removing the needle with protective cap.
Croatian: • Odvojite papirni pokrov s pakiranja igle i izvaditi iglu sa zaštitnom kapicom.
English: While no increased risk of bleeding was observed in clinical trials, concomitant treatment with antiplatelet agents and / or LMWH requires a benefit/risk assessment and close clinical monitoring.
Croatian: Iako nije uočen povećani rizik od krvarenja u kliničkim ispitivanjima, istodobno liječenje antitrombocitnim lijekovima i/ili s LMWH zahtijeva procjenu omjera koristi i rizika i strogo kliničko praćenje.
English: If you forget to use Cablivi
Croatian: Ako ste zaboravili primijeniti Cablivi
English: If emergency surgery is needed, the use of von Willebrand Factor concentrate could be considered to correct hemostasis.
Croatian: Ako je potreban hitan operativni zahvat, može se razmotriti primjena koncentrata von Willebrandovog faktora radi korekcije hemostaze.
English: • bleeding hemorrhoids
Croatian: • krvarenje iz hemeroida
English: The pharmacologic effect of caplacizumab on target inhibition was assessed using two biomarkers for von Willebrand factor activity; ristocetin-induced platelet aggregation (RIPA) and ristocetin cofactor (RICO).
Croatian: Farmakološki učinak kaplacizumaba na inhibiciju ciljnog proteina procijenjen je pomoću dva biomarkera za aktivnost von Willebrandovog faktora; nakupljanje trombocita inducirano ristocetinom (RIPA) i kofaktorom ristocetina (RICO).
English: If you stop using Cablivi
Croatian: Ako prestanete primjenjivati Cablivi
English: Contact your doctor or nurse if this happens.
Croatian: U takvim slučajevima kontaktirajte svog liječnika ili medicinsku sestru.
English: • Hold the syringe at eye level with the needle pointing upwards.
Croatian: • Držite štrcaljku u razini očiju s iglom usmjerenom prema gore.
English: Patients received a single intravenous bolus injection of 10 mg caplacizumab or placebo prior to the first plasma exchange on study.
Croatian: Bolesnici su primili jednu intravensku bolus injekciju 10 mg kaplacizumaba ili placeba prije prve izmjene plazme u ispitivanju.
English: Step 11 - Prepare injection site for injection under the skin
Croatian: Korak 11 - Pripremanje mjesta primjene potkožne injekcije
English: The 10 mg subcutaneous dose in patients with aTTP elicited full inhibition of von Willebrand factor-mediated platelet aggregation, as evidenced by RICO levels of < 20% throughout the treatment period.
Croatian: Supkutane doze od 10 mg u bolesnika s aTTP potakle su potpunu inhibiciju nakupljanja trombocita posredovanog von Willebrandovim faktorom, kao što je to dokazano razinama RICO od < 20% tijekom cijelog trajanja liječenja.
English: Cerebral infarction
Croatian: Moždani infarkt
English: There were no deaths in the caplacizumab group and 3 deaths in the placebo group during the study drug treatment period.
Croatian: Nije bilo smrtnih ishoda u skupini liječenoj kaplacizumabom, dok su u skupini koja je primala placebo bila 3 smrtna ishoda.
English: Do not use solution exhibiting particulates.
Croatian: Nemojte koristiti otopinu koja sadrži čestice.
English: • Prepare a clean flat surface for placing the kit package.
Croatian: • Pripremite čistu ravnu podlogu na koju ćete staviti pakiranje sa setom.
English: The proportion of patients with a recurrence of aTTP (exacerbation or relapse) in the overall study period (including the 28 day follow-up after discontinuation of study drug treatment) was 67% lower in the caplacizumab group (9/72; relapse : 6/72) compared to the placebo group (28/73; relapse 0/73) (p<0.001).
Croatian: Omjer bolesnika s ponavljanjem aTTP-a (pogoršanjem ili recidivom) u ukupnom razdoblju ispitivanja (uključujući razdoblje praćenja u trajanju od 28 dana nakon prestanka uzimanja ispitivanog lijeka) bio je 67 % manji u skupini liječenoj kaplacizumabom (9/72; recidiv : 6/72) u odnosu na skupinu koja je primala placebo (28/73; recidiv 0/73) (p<0,001).
English: Driving and using machines Cablivi is not expected to influence the ability to drive or use machines.
Croatian: Ne očekuje se da Cablivi utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: An embryo-foetal development study was conducted in guinea pigs, with no reported signs of toxicity.
Croatian: Ispitivanje embriofetalnog razvoja provedeno je na zamorcima i nisu prijavljeni znaci toksičnosti.
English: Dedicated animal studies assessing the effects of caplacizumab on male and female fertility have not been performed.
Croatian: Ciljana ispitivanja na životinjama za procjenu učinaka kaplacizumaba na mušku i žensku plodnost još nisu provedena.
English: The pharmacokinetics of caplacizumab depend on the expression of the target von Willebrand factor.
Croatian: Farmakokinetika kaplacizumaba ovisi o ekspresiji ciljanog von Willebrandovog faktora.
English: In animal toxicology studies, no impact of caplacizumab on male and female fertility parameters was observed (see section 5.3).
Croatian: U ispitivanjima toksičnosti na životinjama nije uočen utjecaj kaplacizumaba na parametre muške i ženske plodnosti (vidjeti dio 5.3).
English: If you miss a dose you should still take it if it is within 12 hours of the scheduled time.
Croatian: Ako ste propustili dozu, možete je još uvijek primijeniti unutar 12 sati nakon predviđenog vremena primjene.
English: Name and address of the manufacturer responsible for batch release Ablynx NV
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Ablynx NV
English: Treatment with Cablivi should be initiated and supervised by physicians experienced in the management of patients with thrombotic microangiopathies.
Croatian: Liječenje lijekom Cablivi mora započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s trombotičnom mikroangiopatijom.
English: Citric acid anhydrous Trisodium citrate dihydrate Polysorbate 80
Croatian: Citratna kiselina, bezvodna Trinatrij citrat dihidrat Polisorbat 80
English: No formal study of the effect of hepatic or renal impairment on the pharmacokinetics of caplacizumab has been conducted.
Croatian: Nisu provedena službena ispitivanja utjecaja oštećenja funkcije bubrega ili jetre na farmakokinetiku kaplacizumaba.
English: Cablivi prevents the formation of these blood clots by stopping platelets in the blood from clumping together.
Croatian: Cablivi sprječava stvaranje tih ugrušaka tako što zaustavlja nakupljanje trombocita.
English: Cablivi should only be restarted upon the advice of a physician experienced in the management of thrombotic microangiopathies.
Croatian: Cablivi se smije ponovno primijeniti samo nakon konzultacije s liječnikom s iskustvom u liječenju trombotične mikroangiopatije.
English: • While keeping it vertical, slowly pull the plunger to transfer all the solution into the syringe.
Croatian: • Dok sve držite u okomitom položaju, lagano povucite klip kako bi prebacili svu otopinu u štrcaljku.
English: • Put the syringe with the needle in a disposal container.
Croatian: • Odložite štrcaljku s iglom u spremnik za odlaganje.
English: The pharmacologic effect of caplacizumab on target disposition was measured using von Willebrand factor antigen and factor VIII clotting activity (factor VIII:C) as biomarkers.
Croatian: Farmakološki učinak kaplacizumaba na raspoloživost ciljnog proteina mjerena je pomoću antigena von Willebrandovog faktora i aktivnosti faktora VIII (faktor VIII:C) kao biomarkera.