FrancophonIA/ELRC3.0 huggingface dataset:
English: Only 6 patients had moderate hepatic impairment (1.5 × ULN < bilirubin ≤ 3 × ULN and any AST).
Croatian: Samo 6 bolesnika imalo je umjereno oštećenje jetrene funkfije (bilirubin > 1,5 x GGN i ≤ 3 x GGN i bilo koja vrijednost AST-a).
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: ● prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Do not use these instructions when using a transfer needle to withdraw Hemlibra from vial.
Croatian: Nemojte slijediti ove upute kada za izvlačenje lijeka Hemlibra iz bočice koristite iglu za prijenos.
English: ● If you are not sure what to do, ask your doctor, pharmacist or nurse.
Croatian: Ako niste sigurni što učiniti, pitajte svog liječnika, ljekarnika ili medicinsku sestru.
English: Arm C: includes no prophylaxis period only.
Croatian: Skupina C: uključuje samo razdoblje bez profilakse.
English: Bleed definitions adapted based on ISTH criteria.
Croatian: Definicije krvarenja prilagođene na temelju ISTH kriterija.
English: No data are available with respect to potential side effects of emicizumab on embryo-foetal development.
Croatian: Nisu dostupni podaci o mogućim štetnim učincima emicizumaba na embriofetalni razvoj.
English: There are no data in patients less than 1 year of age.
Croatian: Nema podataka o primjeni u bolesnika mlađih od 1 godine.
English: If you need to use more than 1 vial to get to your prescribed dose, follow these steps after you have drawn up the medicine from the first vial:
Croatian: Ako morate upotrijebiti više od 1 bočice da biste dobili cijelu propisanu dozu, slijedite ove korake nakon što u štrcaljku uvučete lijek iz prve bočice:
English: The NIS is an observational study with the main objective of capturing detailed clinical data on the bleeding episodes and haemophilia medication use of patients with haemophilia A outside of an interventional trial setting.
Croatian: Neintervencijsko ispitivanje je opservacijsko ispitivanje u kojem je glavni cilj prikupiti detaljne kliničke podatke o epizodama krvarenja i primjeni lijekova za hemofiliju među bolesnicima s hemofilijom A izvan intervencijskog ispitivanja.
English: Vials that have been kept at room temperature for more than 7 days or exposed to temperatures above 30 °C should be discarded.
Croatian: Bočice koje su se čuvale na sobnoj temperaturi dulje od 7 dana ili koje su bile izložene temperaturama iznad 30°C treba baciti.
English: Assays containing human coagulation factors are responsive to emicizumab but may overestimate the clinical haemostatic potential of emicizumab.
Croatian: Testovi koji sadrže ljudske faktore koagulacije reagiraju na emicizumab, ali mogu precijeniti njegov klinički hemostatski potencijal.
English: Slowly push the plunger to push the large air bubbles out of the syringe.
Croatian: Polako potisnite klip kako biste istisnuli velike mjehuriće zraka iz štrcaljke.
English: Similar PK profiles were observed following once weekly dosing (3 mg/kg/week for 4 weeks followed by 1.5 mg/kg/week) in adults/adolescents (≥ 12 years) and children (< 12 years) (see Figure 1).
Croatian: Opaženi su slični farmakokinetički profili kod doziranja jedanput na tjedan (3 mg/kg na tjedan tijekom 4 tjedna, a zatim 1,5 mg/kg na tjedan) u odraslih/adolescenata (≥ 12 godina) i djece (< 12 godina) (vidjeti Sliku 1).
English: ● blood clot in a vein near the surface of the skin (superficial thrombophlebitis)
Croatian: ● krvni ugrušak u veni blizu površine kože (površinski tromboflebitis) Prijavljivanje nuspojava
English: You will need to recap the transfer needle after transferring the medicine.
Croatian: Morat ćete ga vratiti na iglu za prijenos nakon što prenesete lijek.
English: Throw away any used syringes and needles.
Croatian: Bacite sve upotrijebljene štrcaljke i igle.
English: Sixty three patients previously treated with prophylactic FVIII were enrolled into Arm D to receiveHemlibra (1.5 mg/kg once weekly).
Croatian: Šezdeset i tri bolesnika koja su prethodno primala profilaksu faktorom VIII bila su uključena u skupinu D, koja je primala lijek Hemlibra (1,5 mg/kg jedanput na tjedan).
English: Where to inject Hemlibra
Croatian: Gdje injicirati lijek Hemlibra
English: Physical health score (range 0 to 100)a
Croatian: Rezultat za tjelesno zdravlje (raspon: 0 - 100)a
English: No data are available on the use of Hemlibra in patients with severe hepatic impairment.
Croatian: Nema dostupnih podataka o primjeni lijeka Hemlibra u bolesnika s teškim oštećenjem jetrene funkcije.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Hemlibra in one or more subsets of the paediatric population in the treatment of hereditary factor VIII deficiency (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Hemlibra u jednoj ili više podskupina pedijatrijske populacije za liječenje nasljednog nedostatka faktora VIII
English: ● blood clot in a vein behind your eye (cavernous sinus thrombosis)
Croatian: ● krvni ugrušak u veni iza oka (tromboza kavernoznog sinusa)
English: Warning that these tests should not be used to monitor for emicizumab activity, determine need for factor replacement dosing, or measure FVIII inhibitors;
Croatian: Upozorenje da se ti testovi ne smiju koristiti za praćenje aktivnosti emicizumaba, utvrđivanje potrebe za primjenom nadomjestaka faktora ili određivanje inhibitora FVIII.
English: Reminder to report any adverse events to their treating doctor.
Croatian: Naputak da prijave sve nuspojave nadležnom liječniku
English: Administration of Hemlibra subcutaneous injection in the upper outer arm should be performed by a caregiver or healthcare professional.
Croatian: Supkutanu injekciju lijeka Hemlibra u vanjski dio nadlaktice treba dati njegovatelj ili zdravstveni radnik.
English: There is limited experience with overdose of Hemlibra.
Croatian: Iskustvo s predoziranjem lijekom Hemlibra je ograničeno.
English: 2.INJECTION
Croatian: 2. INJICIRANJE
English: The total aPCC dose should not exceed 100 U/kg in the first 24-hours of treatment.
Croatian: Ukupna doza aPCC-a u prva 24 sata liječenja ne smije premašiti 100 jedinica/kg.
English: ● For each injection, use a different area of the body to the one you used last time.
Croatian: Za svaku injekciju odaberite drugo područje, različito od prethodne injekcije.
English: Hemlibra solution for injection vials are for single-use only.
Croatian: Bočice lijeka Hemlibra otopina za injekciju namijenjene su samo za jednokratnu uporabu.
English: There were 82 instances of aPCC treatment* in patients receiving Hemlibra prophylaxis, of which eight instances (10%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; two of the eight instances were associated with thrombotic events and three of the eight instances were associated with TMA (Table 3).
Croatian: Među bolesnicima koji su primali profilaksu lijekom Hemlibra zabilježene su 82 epizode liječenja aPCC-om*, od kojih je u njih osam (10%) primijenjena prosječna ukupna količina aPCC-a > 100 jedinica/kg/24 sata tijekom razdoblja od 24 sata ili dulje; dvije od tih osam epizoda bile su povezane s trombotskim događajima, a tri od njih osam s TMA (Tablica 3).
English: Physical health score (range 0 to 100)
Croatian: Rezultat za tjelesno zdravlje (raspon: 0 - 100)
English: ● Once the syringe has been filled with the medicine, the injection must be given immediately.
Croatian: Nakon uvlačenja lijeka u štrcaljku, injekcija se mora odmah primijeniti.
English: Emicizumab restores the tenase cofactor activity of missing activated factor VIII (FVIIIa).
Croatian: Emicizumab ponovno uspostavlja kofaktorsku aktivnost nedostajućeg aktiviranog faktora VIII (FVIIIa) u kompleksu tenaze.
English: ● Laboratory professionals educational material
Croatian: ● Edukacijski materijal za laboratorijske zdravstvene radnike
English: Arm B: includes no prophylaxis period only.
Croatian: Skupina B: uključuje samo razdoblje bez profilakse.
English: Do not save unused medicine in the vial for later use.
Croatian: Nemojte ga čuvati u bočici za kasniju upotrebu.
English: Caution should be used when treating patients who are at high risk for TMA (e.g. have a previous medical history or family history of TMA), or those who are receiving concomitant medications known to be a risk factor for the development of TMA (e.g. ciclosporin, quinine, tacrolimus).
Croatian: Potreban je oprez prilikom liječenja bolesnika s visokim rizikom za TMA (npr. onih koji imaju TMA u osobnoj ili obiteljskoj povijesti bolesti) ili onih koji istodobno primaju lijekove za koje se zna da predstavljaju faktor rizika za razvoj TMA (npr. ciklosporin, kinin, takrolimus).
English: Once completed, keep the transfer needle inserted in the vial and return to Step 6.
Croatian: Nakon toga, držeći iglu za prijenos u bočici, vratite se na 6. korak.
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Croatian: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen
English: Reversible hemorrhage, perivascular mononuclear cell infiltration, degeneration/necrosis of subcutis and swelling of endothelium in the subcutis was noted in animals after subcutaneous injection.
Croatian: U životinja su nakon supkutane injekcije opaženi reverzibilno krvarenje, perivaskularna infiltracija mononuklearnih stanica, degeneracija/nekroza supkutisa i oticanje endotela u supkutisu.
English: ● The other ingredients are L-arginine, L-histidine, L-aspartic acid, poloxamer 188 and water for injections.
Croatian: Drugi sastojci su L-arginin, L-histidin, L-aspartatna kiselina, poloksamer 188 i voda za injekcije.
English: Hemlibra prophylaxis (N = 18)
Croatian: Profilaksa lijekom Hemlibra (N = 18)
English: In contrast, assays containing bovine coagulation factors are insensitive to emicizumab (no activity measured) and can be used to monitor endogenous or infused factor VIII activity, or to measure anti FVIII inhibitors.
Croatian: Nasuprot tome, testovi koji sadrže goveđe faktore koagulacije nisu osjetljivi na emicizumab (ne mjere njegovu aktivnost), pa se mogu koristiti za praćenje aktivnosti endogenog ili infundiranog faktora VIII ili za određivanje inhibitora FVIII.
English: Do not use this medicine if it is cloudy, discoloured, or contains visible particles.
Croatian: Nemojte primijeniti lijek ako primijetite da je mutan, da je promijenio boju ili da sadrži vidljive čestice.
English: For each treatment arm, the mean exposure times (+SD) were 28.86 weeks (8.37) for Arm A, 8.79 (3.62) for Arm B, 21.56 (11.85) for Arm C and 7.08 (3.89) for Arm D. One patient in Arm A withdrew from study prior to initiation of Hemlibra.
Croatian: (+ standardno odstupanje) za svaku liječenu skupinu pojedinačno iznosila je 28,86 tjedana (8,37) za skupinu A; 8,79 (3,62) za skupinu B; 21,56 (11,85) za skupinu C te 7,08 (3,89) za skupinu D.
English: Note: Do not use 3 mL LDS syringe for doses up to 1 mL.
Croatian: Napomena: Nemojte koristiti LDS štrcaljke volumena 3 ml za injiciranje doza do 1 ml.
English: Note: Ensure you have enough medicine in the syringe to complete your dose before moving onto the next step.
Croatian: Napomena: Uvjerite se da je u štrcaljki dovoljno lijeka za primjenu cijele doze prije nego što krenete na sljedeći korak.
English: ● Select and clean your injection site with an alcohol wipe.
Croatian: Odaberite i očistite mjesto injiciranja maramicom natopljenom alkoholom.
English: Refer to the Hemlibra “Instructions for Use” for handling instructions when combining vials in a syringe.
Croatian: Vidjeti ‘Upute za uporabu' lijeka Hemlibra za upute za rukovanje pri kombiniranju sadržaja više bočica u jednoj štrcaljki.
English: Cavg, ss = average concentration at steady state; Cmax, ss = maximum plasma concentration at steady state; Ctrough, ss = trough concentration at steady state; QW = once weekly; Q2W = every two weeks; Q4W = every four weeks.
Croatian: Cavg, ss = prosječna koncentracija u stanju dinamičke ravnoteže; Cmax, ss = maksimalna plazmatska koncentracija u stanju dinamičke ravnoteže; Ctrough, ss = najniža koncentracija u stanju dinamičke ravnoteže.
English: ● Remove the needle and syringe from the injection site at the same angle as inserted.
Croatian: Izvadite iglu i štrcaljku iz mjesta injiciranja pod istim kutom pod kojim ste ih uveli.
English: The amount of Hemlibra solution given in each injection must not be more than 2 mL
Croatian: Volumen otopine lijeka Hemlibra koji se primjenjuje u jednoj injekciji ne smije biti veći od 2 ml.
English: * Emicizumab is a humanised monoclonal modified immunoglobulin G4 (IgG4) antibody produced using recombinant DNA technology in mammalian Chinese Hamster Ovary (CHO) cells For the full list of excipients, see section 6.1
Croatian: *Emicizumab je humanizirano monoklonsko modificirano imunoglobulinsko (IgG4) protutijelo koje se proizvodi tehnologijom rekombinantne DNK na stanicama jajnika kineskog hrčka (CHO).
English: ● Injection needle with safety shield (Used to inject medicine).
Croatian: Igla za injiciranje sa sigurnosnim pokrovom (namijenjena za injiciranje lijeka).
English: These instructions are for use with the Vial Adapter only.
Croatian: Ove se upute odnose samo na uporabu nastavka za bočicu.
English: ● Choose appropriate dosage and volume from vial strengths available.
Croatian: Odaberite odgovarajuću dozu i volumen među dostupnim jačinama lijeka u bočicama.
English: Following intravenous administration of 0.25 mg/kg in healthy subjects, the total clearance of emicizumab was 3.26 mL/kg/day (i.e. 0.228 L/d for a 70-kg adult) and the mean terminal half-life was 26.7 days.
Croatian: Ukupni klirens emicizumaba nakon intravenske primjene doze od 0,25 mg/kg u zdravih ispitanika iznosio je 3,26 ml/kg na dan (tj. 0,228 l na dan za odraslu osobu od 70 kg), dok je srednja vrijednost terminalnog poluvijeka iznosila 26,7 dana.
English: Important: If your prescribed dose is more than the amount of medicine in the vial, withdraw all of the medicine and go to the “Combining Vials” section now.
Croatian: Važno: Ako je propisana doza veća od količine lijeka u bočici, izvucite sav lijek i sada prijeđite na dio ‘Kombiniranje bočica'.
English: These two pharmacodynamic markers do not reflect the true haemostatic effect of emicizumab in vivo (aPTT is overly shortened and reported factor VIII activity may be overestimated) but provide a relative indication of the procoagulant effect of emicizumab.
Croatian: Ta dva farmakodinamička biljega ne odražavaju stvaran hemostatski učinak emicizumaba in vivo (aPTV je previše skraćen, a prikazana aktivnost faktora VIII može biti precijenjena), ali služe kao relativan pokazatelj prokoagulacijskog učinka emicizumaba.
English: ● The recommended places to give an injection are: the front of the waist (lower abdomen), upper outer arms, or the front of the thighs.
Croatian: Preporučena mjesta za injiciranje su donji dio trbuha (abdomena), vanjski dio nadlaktice ili prednji dio bedara.
English: Do not recycle your used sharps disposal container.
Croatian: Nemojte reciklirati upotrijebljen spremnik za zbrinjavanje oštrih predmeta.
English: - properly labelled to warn of hazardous waste inside the container.
Croatian: - koja ima odgovarajuću naljepnicu s upozorenjem da sadrži opasan otpad
English: The decision, to use either the 1.5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks maintenance dose, should be made in consultation with your doctor and, where applicable, with your caregiver.
Croatian: Odluku o tome hoće li se primjenjivati doza održavanja od 1,5 mg/kg jedanput na tjedan, 3 mg/kg svaka dva tjedna ili 6 mg/kg svaka četiri tjedna treba donijeti u dogovoru s liječnikom i, kada je to primjenjivo, Vašim njegovateljem.
English: ● The guide for healthcare professionals shall contain the following key elements: Brief introduction to emicizumab (chemical class, mode of action, pharmacodynamics and indication)
Croatian: - Kratak uvod o emicizumabu (kemijska skupina, mehanizam djelovanja, farmakodinamika i indikacija)
English: Skin and subcutaneous tissue disorders Skin necrosis
Croatian: Poremećaji kože i potkožnog tkiva nekroza kože manje često
English: ● When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to throw away of your sharps disposal container.
Croatian: Kada spremnik za zbrinjavanje oštrih predmeta bude gotovo pun, morat ćete slijediti lokalne smjernice za pravilno zbrinjavanje spremnika za odlaganje oštrih predmeta.
English: The safety and efficacy of emicizumab have not been specifically tested in patients with hepatic impairment.
Croatian: Sigurnost i djelotvornost emicizumaba nisu se posebno ispitivale u bolesnika s oštećenjem jetrene funkcije.
English: Blood and lymphatic system disorders Thrombotic microangiopathy Uncommon Nervous system disorders
Croatian: Poremećaji krvi i limfnog sustava trombotska mikroangiopatija manje često
English: The study evaluated the pharmacokinetics, safety, and efficacy including the efficacy of weekly Hemlibra prophylaxis compared with previous episodic and prophylactic bypassing agent treatment in patients who had participated in the NIS prior to enrolment (intra-patient comparison).
Croatian: U ispitivanju su se ocjenjivale farmakokinetika, sigurnost i djelotvornost, uključujući djelotvornost tjedne profilakse lijekom Hemlibra u usporedbi s prethodnom primjenom lijekova koji zaobilaze akivnost faktora VIII za liječenje epizoda krvarenja i profilaksu u bolesnika koji su prije uključivanja sudjelovali u neintervencijskom ispitivanju (intraindividualna usporedba).
English: ● Alcohol wipes Note: If you need to use more than 1 vial to inject your prescribed dose, you must use a new alcohol wipe for each vial.
Croatian: ● Maramice natopljene alkoholom Napomena: Ako morate upotrijebiti više od 1 bočice da biste injicirali propisanu dozu, za svaku bočicu morate upotrijebiti novu maramicu natopljenu alkoholom.
English: Inject air into vial
Croatian: Ubrizgajte zrak u bočicu
English: ● Hemlibra is given by injection under the skin (subcutaneously).
Croatian: Hemlibra se primjenjuje injekcijom pod kožu (supkutano).
English: Forty-nine patients previously treated with prophylactic bypassing agents were enrolled in Arm C to receive Hemlibra prophylaxis.
Croatian: Četrdeset i devet bolesnika koji su prethodno primali lijekove koji zaobilaze akivnost faktora VIII za profilaksu bili su uključeni u skupinu C i primali su profilaksu lijekom Hemlibra.
English: Following multiple subcutaneous injections in haemophilia A patients, the apparent clearance was 0.272 L/day and the elimination apparent half-life was 26.8 days.
Croatian: Prividni klirens nakon višekratnih supkutanih injekcija u bolesnika s hemofilijom A iznosio je 0,272 l na dan, dok je prividno poluvrijeme eliminacije iznosilo 26,8 dana.
English: ● Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action.
Croatian: Uhvatite nabor kože na odabranom mjestu injiciranja te brzim i čvrstim pokretom ubodite iglu punom duljinom u nabor kože pod kutom od 45° do 90°.
English: ● Patient alert card
Croatian: ● Karticu s upozorenjima za bolesnika
English: Therefore, the dose of bypassing agent required may be lower than the dose you used before starting Hemlibra.
Croatian: Stoga će potrebna doza lijeka koji zaobilazi akivnost faktora VIII možda biti manja nego doza koju ste primjenjivali prije nego što ste započeli liječenje lijekom Hemlibra.
English: ● Keep the vials, needles and syringes out of the sight and reach of children.
Croatian: ● Bočice, igle i štrcaljke čuvajte izvan pogleda i dohvata djece.
English: For further information refer to the section “Disposing of the medicine and supplies”.
Croatian: Za više informacija pogledajte dio ‘Odlaganje lijeka i pribora za primjenu'
English: Important: If your prescribed dose is more than the amount of Hemlibra in the vial, withdraw all medicine and go to the “Combining Vials” section now
Croatian: Važno: Ako je propisana doza veća od količine lijeka Hemlibra u bočici, izvucite sav lijek i sada prijeđite na dio “Kombiniranje bočica”.
English: There are no clinical studies of emicizumab use in pregnant women.
Croatian: Trudnoća Nisu provedena klinička ispitivanja emicizumaba u trudnica.
English: ● Holding the syringe with one hand, press the safety shield down against a flat surface with a firm, quick motion until you hear a “click”.
Croatian: Držeći štrcaljku jednom rukom, čvrstim i brzim pokretom pritisnite sigurnosni pokrov o ravnu površinu dok ne čujete “klik”.
English: Do not use if the expiry date has passed.
Croatian: Nemojte ih upotrijebiti ako im je istekao rok valjanosti.
English: Please see section 4.2 and package leaflet (section 7 Instructions for Use), for additional information on administration.
Croatian: Vidjeti dio 4.2 i uputu o lijeku (dio 7.
English: Criteria: Stainless steel with Luer-lock connection, gauge 26 G (acceptable range: 25-27 gauge), length preferably 9 mm (3/8″) or maximally 13mm (½″), preferably including needle safety feature.
Croatian: Kriteriji: Nehrđajući čelik i Luer-Lock priključak, veličina 26 G (prihvatljiv raspon: 25 - 27 G), duljina po mogućnosti 9 mm ili najviše 13 mm, po mogućnosti sa sigurnosnim pokrovom za iglu.
English: ● Check the expiry date on the box, on the vial label and on the supplies listed below.
Croatian: Provjerite rok valjanosti na kutiji, naljepnici bočice i dolje navedenom priboru.
English: ● Do not try to remove the used injection needle from the used syringe.
Croatian: Nemojte pokušavati skinuti iglu za injiciranje s upotrijebljene štrcaljke.
English: The apparent volume of distribution (V/F), estimated from the population PK analysis, in haemophilia A patients following multiple subcutaneous doses of emicizumab was 10.4 L. Metabolism
Croatian: Prividni volumen distribucije (V/F) u bolesnika s hemofilijom A nakon višekratnih supkutanih doza emicizumaba, procijenjen na temelju populacijske farmakokinetičke analize, iznosio je 10,4 l.
English: ● destruction of red blood cells (thrombotic microangiopathy)
Croatian: ● propadanje crvenih krvnih stanica (trombotska mikroangiopatija)
English: Hemlibra is provided in single-use vials as ready to use solution which does not need to be diluted.
Croatian: Hemlibra dolazi u bočicama za jednokratnu uporabu u obliku otopine spremne za primjenu koju nije potrebno razrjeđivati.
English: In pooled phase III clinical trials, serious thrombotic events were reported in less than 1 % of patients (2/373) and in 6.5 % of patients (2/31) who received at least one dose of aPCC while being treated with emicizumab.
Croatian: Na temelju objedinjenih podataka iz kliničkih ispitivanja faze III, ozbiljni trombotski događaji prijavljeni su u manje od 1% bolesnika (2/373) te u 6,5% bolesnika (2/31) koji su tijekom liječenja emicizumabom primili najmanje jednu dozu aPCC-a.
English: Eighty-nine patients previously treated with episodic (“on demand”) FVIII were randomized in a 2:2:1 ratio to receive Hemlibra either once weekly (Arm A; N = 36), every two weeks (Arm B; N = 35) or no prophylaxis (Arm C; N = 18), with stratification by prior 24-week bleed rate (< 9 or ≥ 9).
Croatian: Osamdeset i devet bolesnika koji su prethodno primali FVIII za liječenje epizoda krvarenja („po potrebi“) bilo je randomizirano u omjeru 2:2:1 za primjenu lijeka Hemlibra jedanput na tjedan (skupina A; N = 36) ili svaka dva tjedna (skupina B; N = 35) ili za liječenje bez profilakse (skupina C; N = 18), uz stratifikaciju prema stopi krvarenja u prethodna 24 tjedna (< 9 ili ≥ 9).
English: How Hemlibra works
Croatian: Kako Hemlibra djeluje