natgillin/translations-raw huggingface dataset:
There were no deaths in the caplacizumab group and 3 deaths in the placebo group during the study drug treatment period.
V skupini s kaplacizumabom ni umrl noben bolnik, v skupini s placebom pa so v času zdravljenja s študijskim zdravilom umrli 3 bolniki.
Injections into the area around the navel should be avoided and consecutive injections should not be administered in the same abdominal quadrant.
Injiciranju v predel okoli popka se je treba izogibati; v isto četrtino trebuha se ne sme injicirati zaporedoma.
9052 Zwijnaarde, Belgium
9052 Zwijnaarde, Belgija
Cablivi is for single use only.
Zdravilo Cablivi je samo za enkratno uporabo.
Vial (type I glass) with a stopper (butyl rubber), a seal (aluminium) and a cap (polypropylene), containing 10 mg of caplacizumab.
Viala (steklo tipa I) z zamaškom (butilna guma), tesnilom (aluminij) in zaporko (polipropilen), ki vsebuje 10 mg kaplacizumaba.
If more than 12 hours have passed since the dose should have been given, do not take the missed dose, but inject the next dose at the usual time.
Če je od časa, ko bi si morali dati odmerek, poteklo več kot 12 ur, izpuščenega odmerka ne nadomestite, temveč si naslednji odmerek injicirajte ob običajnem času.
• Turn the whole - vial, adapter and syringe - right-side up (with the syringe at the top).
• Vse - vialo, nastavek in injekcijsko brizgo - obrnite s pravo stranjo navzgor (z injekcijsko brizgo na vrhu).
• Clean the exposed rubber stopper using one of the alcohol pads provided and allow it to dry for a few seconds.
• Izpostavljen gumijast zamašek očistite z eno od priloženih alkoholnih blazinic in počakajte, nekaj sekund, da se osuši.
What you need to know before you use Cablivi
Kaj morate vedeti, preden boste vzeli zdravilo Cablivi
The first dose of Cablivi is to be administered as an intravenous injection.
Prvi odmerek zdravila Cablivi je treba dati v obliki intravenske injekcije.
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.
Zdravljenje s kaplacizumabom je zmanjšalo povprečno število dni izmenjave plazme, uporabljeno količino plazme, povprečno dolžino zdravljenja na oddelku za intenzivno nego in povprečno dolžino hospitalizacije v obdobju zdravljenja s študijskim zdravilom.
In this study, 145 patients experiencing an episode of aTTP were randomised (72 to caplacizumab and to 73 placebo).
V tej študiji je bilo randomiziranih 145 bolnikov, ki je doživelo epizodo aTTP (72 na prejemanje kaplacizumaba in 73 na prejemanje placeba).
Take care that the adapter does not come away from the vial.
Pazite, da se nastavek ne loči od viale.
There are no data on the use of caplacizumab in pregnant women.
Podatkov o uporabi kaplacizumaba pri nosečnicah ni.
Leave the adapter in its opened plastic packaging.
Nastavek pustite v odprti plastični ovojnini.
Content :
Vsebina:
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).
Skladno z načinom delovanja so toksikološke študije kaplacizumaba pokazale večjo tendenco h krvavitvam pri morskih prašičkih (hemoragično podkožno tkivo na mestu injiciranja) in opicah cynomolgus (hemoragično podkožno tkivo na mestu injiciranja, krvavitev iz nosu, pretirana menstrualna krvavitev, hematom na mestih prijemanja živali ali eksperimentalnih postopkih, podaljšana krvavitev na mestih injiciranja).
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.
Zdravniku povejte tudi, če uporabljate antikoagulante, kot so antagonisti vitamina K, rivaroksaban, apiksaban za zdravljenje krvnih strdkov ali protitrombocitna zdravila, kot sta acetilsalicilna kislina ali nizkomolekularni heparin, ki preprečujejo strjevanje krvi.
Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.
Zdravilo Cablivi je indicirano za zdravljenje odraslih, ki imajo epizode pridobljene trombotične trombocitopenične purpure (aTTP - acquired thrombotic thrombocytopenic purpura), skupaj z izmenjavo plazme in imunosupresivnim zdravljenjem.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Multipack: 7 packs of 1 single dose kit.
FARMACEVTSKA OBLIKA IN VSEBINA prašek in vehikel za raztopino za injiciranje Večodmerno pakiranje: 7 enoodmernih pakiranj
What Cablivi is and what it is used for
Kaj je zdravilo Cablivi in za kaj ga uporabljamo
As a precautionary measure, it is preferable to avoid the use of Cablivi during pregnancy.
Zaradi previdnosti se je uporabi zdravila Cablivi med nosečnostjo najbolje izogniti.
The results indicated exposure to caplacizumab in dams and, to a much lesser extent, foetuses, with no reported effects on foetal development.
Rezultati kažejo, da so samice matere izpostavljene kaplacizumabu, plodovi pa v veliko manjši meri; o vplivu na razvoj plodu niso poročali.
The patient should also notify the physician who supervises the treatment with Cablivi about the planned procedure.
Bolnik mora zdravnika, ki nadzira zdravljenje z zdravilom Cablivi, obvestiti o načrtovanem posegu.
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).
Noben od bolnikov, zdravljenih s kaplacizumabom (0/72), ni bil odporen na zdravljenje (opredeljeno kot odsotnost podvojitve števila trombocitov po 4 dneh standardnega zdravljenja in zvišanja LDH) v primerjavi s tremi bolniki v skupini s placebom (3/73).
Leave the adapter attached to the vial, still in its outer packaging.
Nastavek pustite priključen na vialo, še vedno v zunanji ovojnini.
Do not return Cablivi to refrigerated storage after storage at room temperature.
Zdravila Cablivi, ki ste ga shranjevali pri sobni temperaturi, ne vračajte v hladilnik za ponovno shranjevanje.
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).
Študij medsebojnega delovanja, v katerih bi ocenili uporabo kaplacizumaba s peroralnimi antikoagulanti (npr. antagonisti vitamina K, direktnimi peroralnimi antikoagulanti, kot so zaviralci trombina ali zaviralci faktorja Xa) ali velikimi odmerki heparina, niso izvedli (glejte poglavje 4.4 Pri sočasni uporabi peroralnih antikoagulantov ali velikih odmerkov heparina).
If you forget to use Cablivi
Če pozabite uporabiti zdravilo Cablivi
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).
Zdravljenje s kaplacizumabom je povzročilo 74-% zmanjšanje opazovanega dogodka, sestavljenega iz odstotka bolnikov, ki so umrli zaradi aTTP (0/72; placebo 3/73), imeli poslabšanje aTTP (3/72; placebo 28/73) ali vsaj en velik trombembolični dogodek v času zdravljenja s študijskim zdravilom (6/72; placebo 6/73) (p < 0,0001).
• Unpack the needle by tearing the paper cover off the needle packaging and removing the needle with protective cap.
• Iglo razpakirajte tako, da raztrgate papirnat ovoj s pakiranja igle in odstranite iglo z zaščitno zaporko.
The pharmacokinetics of caplacizumab have been investigated in healthy subjects after single intravenous infusions and after single and repeated subcutaneous injections.
Farmakokinetiko kaplacizumaba so preučili pri zdravih osebah po enkratnem intravenskem infundiranju in po enkratnem in ponavljajočem subkutanem injiciranju.
Place the tip of the syringe on the connector part of the vial adapter.
Konico brizge položite na priključni del nastavka viale.
Do not use solution exhibiting particulates.
Raztopine z delci ne uporabljajte.
Your doctor will decide if it can be postponed or if you should stop Cablivi before your surgery or dental treatment.
Zdravnik se bo odločil, ali ga je možno preložiti ali pa morate pred kirurškim ali zobozdravstvenim posegom prekiniti zdravljenje z zdravilom Cablivi.
• are using anticoagulants such as vitamin K antagonists , rivaroxaban, apixaban (which treat blood clots).
• uporabljate antikoagulante, kot so antagonosti vitamina K, rivaroksaban, apiksaban (za zdravljenje krvnih strdkov).
• subsequent doses: - 1 vial once daily as a subcutaneous injection (under the skin of the belly) - the subcutaneous injection will be given after each daily plasma exchange - after the daily plasma exchange finishes, your treatment with Cablivi will continue for at least 30 days with injection of 1 vial once daily.
• naslednji odmerki: - 1 viala enkrat na dan v obliki subkutane injekcije (pod kožo na trebuhu) - subkutane injekcije se da po vsaki dnevni izmenjavi plazme - po koncu dnevnih izmenjav plazme se zdravljenje z zdravilom Cablivi nadaljuje še vsaj 30 dni z injiciranjem 1 viale enkrat na dan. - zdravnik vam lahko naroči, naj z dnevnim zdravljenjem nadaljujete, dokler osnovni znaki bolezni ne minejo
• Gently pinch the cleaned skin between your thumb and forefinger to make a fold.
• Očiščeno kožo nežno stisnite med palec in kazalec, da naredite gubo.
Pharmacokinetics in patients with aTTP were investigated upon single intravenous and repeated subcutaneous injections.
Farmakokinetiko pri bolnikih s aTTP so preučili po enkratnem intravenskem in po ponavljajočem subkutanem injiciranju.
The t1/2 of caplacizumab is, therefore, concentrationand target level-dependent.
Zato je t1/2 kaplacizumaba odvisen od ravni njegove koncentracije in ravni tarčnega mesta.
If you miss a dose you should still take it if it is within 12 hours of the scheduled time.
Če izpustite odmerek, ga uporabite, če je od načrtovanega časa poteklo manj kot 12 ur.
If at the end of this treatment period there was evidence of persistent underlying disease activity (indicative of an imminent risk for recurrence), treatment could be extended weekly for a maximum of 4 weeks, together with optimisation of immunosuppression.
Če je bila po koncu tega obdobja zdravljenja še vedno prisotna aktivnost osnovne bolezni (kar je kazalo na grozeče tveganje za ponovitev), je bilo možno zdravljenje tedensko podaljševati za največ 4 tedne, skupaj z optimizacijo imunosupresije.
• multipacks each containing 7 single packs
• večodmernem pakiranju, ki vsako vsebuje 7 enoodmernih pakiranj
Driving and using machines Cablivi is not expected to influence the ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ne pričakuje se, da bi zdravilo Cablivi vplivalo na sposobnost upravljanja vozil in strojev.
• bleeding hemorrhoids
• krvavitev iz hemoroida
• Make sure the kit package is complete.
• Preverite, ali je pakiranje kompletno.
Adverse reactions are listed below by MedDRA system organ class and by frequency.
Neželeni učinki so spodaj našteti po organskih sistemih MedDRA in pogostnosti.
• Multipack containing 7 single packs.
• večodmerno pakiranje, ki vsebuje 7 enoodmernih pakiranj.
The pharmacokinetics of caplacizumab depend on the expression of the target von Willebrand factor.
Farmakokinetika kaplacizumaba je odvisna od izraženosti tarčnega von Willebrandovega faktorja.
• Allow the vial with connected syringe to stand on the surface for 5 minutes at room temperature to allow the solution to completely dissolve.
• Vialo s priključeno injekcijsko brizgo pustite stati na površini 5 minut na sobni temperaturi, da se raztopina povsem raztopi.
• black, tarry stools
• črno, katranasto blato
No formal study of the effect of hepatic or renal impairment on the pharmacokinetics of caplacizumab has been conducted.
Formalnih študij učinka okvare jeter ali ledvic na farmakokinetiko kaplacizumaba niso izvedli.
Tell your doctor if you are pregnant or plan to get pregnant.
Če ste noseči ali načrtujete zanositev, to povejte zdravniku.
Do not remove the syringe from the vial.
Injekcijske brizge ne odstranjujte od viale.
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).
Delež bolnikov s ponovitvijo aTTP (poslabšanje ali recidiv) v celotnem študijskem obdobju (vključno z 28-dnevnim spremljanjem po prenehanju zdravljenja s študijskim zdravilom) je bil 67 % manjši v skupini s kaplacizumabom (9/72; ponovitev: 6/72) v primerjavi s skupino s placebom (28/73; ponovitev 0/73) (p < 0,001).
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.
Zdravnik vam bo svetoval, ali naj prekinete dojenje ali uporabo zdravila Cablivi, po presoji koristi dojenja za otroka in koristi zdravljenja z zdravilom Cablivi za vas.
What Cablivi looks like and contents of the pack
Izgled zdravila Cablivi in vsebina pakiranja
• Hold this skin fold during the entire injection.
• Kožno gubo držite ves čas injiciranja.
If at the end of this treatment period there were was evidence of ongoing underlying disease, open-label treatment with caplacizumab could be extended weekly for a maximum of 4 weeks, together with optimisation of immunosuppression.
Če so bili na koncu tega obdobja zdravljenja še prisotni znaki osnovne bolezni, je bilo možno odprto zdravljenje s kaplacizumabom tedensko podaljševati za največ 4 tedne, skupaj z optimizacijo imunosupresije.
Treatment with Cablivi should be initiated and supervised by physicians experienced in the management of patients with thrombotic microangiopathies.
Zdravljenje z zdravilom Cablivi mora uvesti in nadzorovati zdravnik z izkušnjami v zdravljenju bolnikov s trombotičnimi mikroangiopatijami.
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.
V testih toksičnosti pri ponavljajočih odmerkih pri opicah cynomolgus niso opazili vpliva kaplacizumaba na parametre plodnosti pri samcih (velikost mod, funkcija sperme, histopatološke analize mod in obmodka) in samicah (histopatološke analize razmnoževalnih organov, periodična vaginalna citologija).
Do not use Cablivi if you notice any particulate matter or discolouration prior to administration.
Zdravila Cablivi ne uporabljajte, če pred dajanjem opazite trde delce ali obarvanje.
Cablivi prevents the formation of these blood clots by stopping platelets in the blood from clumping together.
Zdravilo Cablivi prepreči nastajanje teh krvnih strdkov tako, da prepreči združevanje trombocitov v krvi.
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.
10 mg subkutani odmerek pri bolnikih z aTTP je izzval popolno zaviranje agregacije trombocitov, pri kateri posreduje von Willebrandov faktor, kar dokazujejo ravni testa RICO < 20 % med celotnim časom zdravljenja.
• if you are allergic to caplacizumab or any of the other ingredients in this medicine (listed in section 6)
Ne uporabljajte zdravila Cablivi • če ste alergični na kaplacizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If you stop using Cablivi
Če prenehate uporabljati zdravilo Cablivi
• Slowly push the syringe's plunger down until the syringe is empty.
• Počasi potiskajte bat injekcijske brizge navzdol, dokler ni injekcijska brizga prazna.
• Immediately after the injection, move the needle safety shield over the needle, until it clicks into place.
• Takoj po injiciranju povlecite varnostni ščit igle čez iglo, da se zaskoči.
Use of Cablivi is not recommended during pregnancy.
Uporaba zdravila Cablivi med nosečnostjo ni priporočljiva.
• Pull back the needle safety shield.
• Varnostni ščit igle povlecite nazaj.
Treatment with Cablivi is started by a doctor experienced in blood disorders.
Zdravljenje z zdravilom Cablivi uvede zdravnik z izkušnjami v zdravljenju bolezni krvi.
A follow-up toxicokinetic study in pregnant guinea pigs assessed exposure of caplacizumab in the dams and foetuses.
Nadaljnja študija toksikokinetike pri brejih morskih prašičkih je ocenjevala izpostavljenost samic mater in plodov kaplacizumabu.
Other medicines and Cablivi Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
• 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.
• Z nastavka odstranite plastično ovojnino tako, da vialo držite v eni roki in z drugo roko pritiskate na strani ovojnine nastavka, nato pa ovojnino dvignete navzgor.
• Place all components of the kit on the clean flat surface.
• Vse komponente kompleta položite na čisto in ravno površino.
The pharmacokinetics of caplacizumab were determined using a population pharmacokinetic analysis on pooled pharmacokinetic data.
Farmakokinetika kaplacizumaba je bila določena na podlagi združenih farmakokinetičnih podatkov populacijske farmakokinetične analize kaplacizumaba.
• Keep the vial standing vertically on the surface with the syringe pointing downwards.
• Viala naj stoji vertikalno na površino z injekcijsko brizgo, ki gleda navzdol.
Patients received a single intravenous bolus injection of 10 mg caplacizumab or placebo prior to the first plasma exchange on study.
Bolniki so v študiji prejeli eno intravensko bolusno injekcijo z 10 mg kaplacizumaba ali placeba pred prvo izmenjavo plazme.
Dedicated animal studies assessing the effects of caplacizumab on male and female fertility have not been performed.
Namenskih študij na živalih, s katerimi bi ocenjevali učinek kaplacizumaba na plodnost samcev in samic, niso opravili.
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).
Farmakološki učinek kaplacizumaba na zaviranje tarčnega mesta so ocenili z dvema biomarkerjema aktivnosti von Willebrandovega faktorja: z agregacijo trombocitov z ristocetinom (RIPA - ristocetininduced platelet aggregation) in z ristocetinskim kofaktorjem (RICO - ristocetin cofactor).
• are using anti-platelet agents such as aspirin, or low molecular weight heparin (which prevent blood clots).
• uporabljate protitrombocitna zdravila, kot sta acetilsalicilna kislina ali nizkomolekularni heparin (ki preprečujejo strjevanje krvi).
Name and address of the manufacturer responsible for batch release Ablynx NV
Ime in naslov izdelovalca, odgovornega za sproščanje serij Ablynx NV
• Place the adapter over the vial, while keeping the adapter in its plastic packaging.
• Nastavek položite čez vialo, medtem pa naj nastavek ostane v plastični ovojnini.
If emergency surgery is needed, the use of von Willebrand Factor concentrate could be considered to correct hemostasis.
Če je potrebna nujna operacija, je treba za korekcijo hemostaze razmisliti o uporabi koncentrata von Willebrandovega faktorja.
It is used to treat an episode of acquired thrombotic thrombocytopenic purpura in adults.
Uporablja se za zdravljenje epizode pridobljene trombotične trombocitopenične purpure pri odraslih.
• Put the syringe with the needle in a disposal container.
• Injekcijsko brizgo z iglo zavrzite v vsebnik za odpadke.
Studies in guinea pigs showed no effect of caplacizumab on the dams or foetuses (see section 5.3).
Študije na morskih prašičkih niso pokazale nikakršnega učinka kaplacizumaba na samico mater ali plod (glejte poglavje 5.3).
Instructions for healthcare professionals on how to inject Cablivi into your vein are at the end of the leaflet.
Navodila za zdravstvene delavce o injiciranju zdravila Cablivi v veno so na koncu navodila.
Do not use this medicine after the expiry date stated on the label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
• Holding the syringe in your hand, break off the white cap with your other hand.
• Injekcijsko brizgo držite v roki in z drugo roko odlomite belo zaporko.
Cablivi is provided as:
Zdravilo Cablivi je na voljo kot:
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mL water for injections
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 ml vode za injekcije
• Carefully remove the needle protection cap from the needle and throw it away.
• Z igle nežno odstranite zaščitno zaporko in jo zavrzite.
• After cleaning, do not touch the rubber stopper or allow it to touch any surface.
• Po čiščenju se gumijastega zamaška več ne dotikajte in ne dovolite, da se dotakne kakšne druge površine.
If more than 12 hours have passed since the dose was to have been given, the missed dose should NOT be administered and the next dose should be administered per the usual dosing schedule.
Če mine več kot 12 ur od takrat, ko bi bilo treba odmerek dati, se izpuščenega odmerka NE sme dati; naslednji odmerek se da po običajnem urniku odmerjanja.
If needed, the use of von Willebrand Factor concentrate could be considered to correct hemostasis.
Po potrebi se lahko za korekcijo hemostaze razmisli o uporabi koncentrata von Willebrandovega faktorja.
This was followed by daily subcutaneous injections of 10 mg caplacizumab or placebo after completion of each plasma exchange for the duration of the daily plasma exchange period and for 30 days thereafter.
Temu je sledilo dnevno subkutano injiciranje 10 mg kaplacizumaba ali placeba vsakokrat po izvedeni izmenjavi plazme, kar se je nadaljevalo celotno obdobje dnevne izmenjave plazme in še 30 dni zatem.
• Put the vial and the attached adapter into the supplied disposal container.
• Vialo in priključen nastavek odložite v vsebnik za odpadke, ki so vam ga dali.
Do not shake it.
Ne stresajte je.
• While keeping it vertical, slowly pull the plunger to transfer all the solution into the syringe.
• Držite jo vertikalno in počasi vlecite za bat, da vso raztopino prenesete v injekcijsko brizgo.
First dose Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.
Prvi odmerek Intravenska injekcija 10 mg kaplacizumaba pred izmenjavo plazme.
The intravenous bolus injection of Cablivi given at the start of the treatment must be administered by a health care professional.
Intravensko bolusno injekcijo zdravila Cablivi na začetku zdravljenja mora dati zdravstveni delavec.
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.
Farmakološki učinek kaplacizumaba na razpoložljivost tarčnega mesta so izmerili z antigenom von Willebrandovega faktorja in aktivnostjo strjevanja faktorja VIII (faktor VIII:C) kot biomarkerjema.