FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in Arm C could switch to Hemlibra (3 mg/kg every two weeks) after completing at least 24 weeks without prophylaxis.
Danish: Patienterne i arm C kunne skifte til Hemlibra (3 mg/kg hver 2. uge) efter gennemførelse af mindst 24 uger uden profylakse.
English: Table 14 Mean (± SD) steady-state emicizumab concentrations
Danish: Tabel 14 Middelværdi (± standardafvigelse) af emicizumab koncentrationer ved steady-state
English: The following adverse drug reactions (ADRs) are based on pooled data from four phase III clinical trials (adult and adolescent studies [BH29884 - HAVEN 1, BH30071 - HAVEN 3, and BO39182HAVEN 4] and a paediatric study BH29992 - HAVEN 2]), in which a total of 373 male patients with haemophilia A received at least one dose of Hemlibra as routine prophylaxis.
Danish: Følgende bivirkninger er baseret på poolede data fra fire kliniske fase III-studier (studier med voksne og unge (BH29884 - HAVEN 1, BH30071 - HAVEN 3 og BO39182 - HAVEN 4) og et pædiatrisk studie (BH29992 - HAVEN 2)), hvor i alt 373 mandlige patienter med hæmofili A fik mindst én dosis Hemlibra som rutinemæssig profylakse.
English: The maintenance dose regimen should be selected based on physician and patient/caregiver dosing regimen preference to support adherence.
Danish: Vedligeholdelsesdosis skal vælges på baggrund af lægens samt patientens/omsorgspersonens doseringspræference for at supportere adhærens.
English: - properly labelled to warn of hazardous waste inside the container.
Danish: - er korrekt mærket med advarsel om, at beholderen indeholder farligt affald.
English: At the time of the primary analysis, two patients underwent up-titration of their maintenance dose to 3 mg/kg once weekly.
Danish: På tidspunktet for den primære analyse gennemgik to patienter optitrering af deres vedligeholdelsesdosis til 3 mg/kg en gang om ugen.
English: Mean (±95% CI) plasma emicizumab concentration versus time profiles for patients ≥ 12 years (studies HAVEN 1 and HAVEN 3) compared with patients < 12 years (study HAVEN 2)
Danish: Figur 1 Middelværdi (± 95 % konfidensinterval) af emicizumab plasmakoncentration versus tidsprofiler for patienter ≥ 12 år (HAVEN 1- og HAVEN 3-studier) sammenlignet med patienter < 12 år (HAVEN 2-studiet)
English: ● severe damage of the skin tissue (skin necrosis)
Danish: ● svær beskadigelse af huden (hudnekrose)
English: Treatment with bypassing agents should be discontinued the day before starting Hemlibra therapy.
Danish: Behandling med lægemidler med bypassing aktivitet skal seponeres dagen før behandling med Hemlibra påbegyndes.
English: Sixty three patients previously treated with prophylactic FVIII were enrolled into Arm D to receiveHemlibra (1.5 mg/kg once weekly).
Danish: 63 patienter, som tidligere var behandlet profylaktisk med FVIII, blev inkluderet i arm D til behandling med Hemlibra (1,5 mg/kg en gang om ugen).
English: If you forget to use Hemlibra
Danish: Hvis du har glemt at tage Hemlibra
English: ● either haemophilia A who have developed factor VIII inhibitors
Danish: ● enten hæmofili A, som har udviklet faktor VIII-inhibitorer
English: ● Check your dose, ensure the top rim of the plunger is in line with the mark on the syringe for your prescribed dose.
Danish: ● Kontrollér din dosis og sørg for, at den øverste kant på stemplet er på linje med det mærke på sprøjten, der passer til din ordinerede dosis.
English: Patients presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13 activity.
Danish: Patienter havde trombocytopeni, mikroangiopatisk hæmolytisk anæmi og akut nyreskade uden samtidig nedsat ADAMTS13 aktivitet.
English: Due to the short half-life of FVIII, no carryover effect is assumed after it's discontinuation.
Danish: På grund af FVIIIs korte halveringstid, kan ingen overførelseseffekt antages efter seponering.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelig: kan påvirke mere end 1 ud af 10 patienter
English: ● Guide for patients/carers
Danish: ● Vejledning for patienter/omsorgspersoner
English: However, the possibility of thrombotic events should be considered when systemic anti-fibrinolytics are used in combination with aPCC or rFVIIa in patients receiving emicizumab.
Danish: Imidlertid bør risikoen for trombotiske hændelser overvejes, når systemiske anti-fibrinolytika anvendes i kombination med aPCC eller rFVIIa hos patienter, der får emicizumab.
English: - Activated partial thromboplastin time (aPTT) - Bethesda assays (clotting-based) for FVIII inhibitor titers - One-stage, aPTT-based, single-factor assays - aPTT-based activated protein C resistance (APC-R) - Activated clotting time (ACT)
Danish: - Aktiveret partiel thromboplastintid (aPTT) - Bethesda test (koagulationsbaseret) for FVIII inhibitor titer - One-stage, aPTT-baseret, enkelt-faktor tests - aPTT-baseret aktiveret protein C resistens (APC-R) - Aktiveret koagulationstid (ACT)
English: Each carton contains one vial.
Danish: Hver æske indeholder ét hætteglas.
English: This rapid improvement is distinct from the usual clinical course observed in atypical hemolytic uremic syndrome and classic TMAs, such as thrombotic thrombocytopenic purpura (see section 4.8).
Danish: Denne hastige forbedring er anderledes end det kliniske forløb for atypisk hæmolytisk uræmisk syndrom, og klassiske tilfælde af TMA, som f.eks. trombotisk trombocytopenisk purpura (se pkt.
English: The solution should be discarded if particulate matter is visible or product is discoloured.
Danish: Opløsningen skal smides ud, hvis der kan ses urenheder eller misfarvning af produktet.
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).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Helimbra i en eller flere undergrupper af den pædiatriske population ved behandling af den arvelige faktor VIII-mangel.
English: *Vascular disorders is a secondary SOC for cavernous sinus thrombosis.
Danish: *Vaskulære sygdomme er en sekundær systemorganklasse for kavernøs sinustrombose.
English: After you inject your dose, throw away any unused Hemlibra left in the vial.
Danish: Når du har fået injektionen, skal eventuelle rester af ubrugt Hemlibra i hætteglasset smides ud.
English: In HAVEN 2, HRQoL for patients aged ≥ 8 to < 12 years was evaluated at week 25 based on the Haemo-QoL-SF questionnaire for children(see Table 13).
Danish: I HAVEN 2 blev helbredsrelateret livskvalitet for patienter i alderen ≥ 8 til < 12 år undersøgt ved uge 25 baseret på Haem-QoL-SF-spørgeskemaet for børn (se tabel 13).
English: Coagulation laboratory tests based on intrinsic clotting, including the activated clotting time (ACT), activated partial thromboplastin time (e.g. aPTT), measure the total clotting time including time needed for activation of FVIII to FVIIIa by thrombin.
Danish: Koagulationstest baseret på intern koagulationsaktivering, inklusive aktiveret koagulationstid (ACT), aktiveret partiel thromboplastintid (fx aPTT), måler den totale koagulationstid, inklusive den tid, det kræves for at aktivere faktor VIII (FVIII) til faktor VIIIa (FVIIIa) ved hjælp af trombin.
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:
Danish: Hvis du har brug for mere end 1 hætteglas for at få din dosis medicin, skal du gøre følgende efter du har trukket medicinen op fra det første hætteglas:
English: ● If you forget your scheduled injection, inject the forgotten dose as soon as possible before the day of the next scheduled dose.
Danish: ● Hvis du glemmer din injektion med Hemlibra, skal du tage den manglende injektion så hurtigt som muligt, og senest dagen før den næste planlagte dosis.
English: Use of Hemlibra in patients aged 65 and over with haemophilia A is supported by adult and adolescent studies HAVEN 1, HAVEN 3, and HAVEN 4.
Danish: Brug af Hemlibra til patienter i alderen 65 år og derover med hæmofili A er understøttet af studierne HAVEN 1, HAVEN 3 og HAVEN 4 med voksne og unge.
English: ● To correctly insert the needle under the skin, pinch a fold of loose skin at the clean injection site with your free hand.
Danish: ● For korrekt placering af nålen under huden, kan du, på det rengjorte sted, tage fat om en hudfold med din frie hånd.
English: 1 mL syringe
Danish: 1 ml sprøjte
English: Your healthcare provider should show you how to prepare, measure, and inject Hemlibra properly before you use it for the first time.
Danish: Lægen eller sygeplejersken vil vise dig, hvordan du forbereder Hemlibra, får opmålt den rigtige dosis og hvordan injektionen gives korrekt, inden du selv skal gøre det første gang.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Note: Used for withdrawing medicine from the vial to the syringe.
Danish: Bemærk: Anvendes til at overføre medicin fra hætteglasset til sprøjten.
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).
Danish: Lignende farmakokinetiske profiler blev observeret efter dosering en gang om ugen (3 mg/kg/uge i 4 uger efterfulgt af 1,5 mg/kg/uge) hos voksne/unge (≥ 12 år) og børn (< 12 år) (se figur 1).
English: The Adapted InhibQoL is a valid and reliable measure of HRQoL.
Danish: Adapted InhibQoL er en valid og pålidelig måling af helbredsrelateret livskvalitet.
English: In case of thrombotic complication, the physician should consider discontinuing rFVIIa or FVIII and interrupt Hemlibra prophylaxis as clinically indicated.
Danish: I tilfælde af trombotiske komplikationer skal lægen overveje at seponere behandling med rFVIIa eller FVIII og afbryde Hemlibra-profylakse, som klinisk indiceret.
English: Before using the medicine, check the solution for particles or discoloration.
Danish: Inden du bruger Hemlibra, skal du undersøge opløsningen for partikler og misfarvning.
English: Forty one patients ≥ 12 years old were evaluated for efficacy with a median observation time of 25.6 weeks (range 24.1-29.4).
Danish: Effekten blev undersøgt hos 41 patienter ≥ 12 år med en median observationstid på 25,6 uger (interval 24,1
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
Danish: Det tilsyneladende fordelingsvolumen (V/F), estimeret ud fra den farmakokinetiske populationsanalyse hos hæmofili A-patienter efter gentagne, subkutane injektioner af emicizumab var 10,4 l.
English: Prophylactic therapy with Hemlibra shortens the aPTT and increases the reported factor VIII activity (using a chromogenic assay with human coagulation factors).
Danish: Profylaktisk behandling med Hemlibra forkorter aPTT og øger faktor VIII-aktiviteten (målt ved kromogen test med humane koagulationsfaktorer).
English: Thus, the effect of emicizumab on male and female fertility is unknown.
Danish: Det vides derfor ikke om emicizumab påvirker den mandlige og kvindelige fertilitet.
English: Emicizumab remains active in the presence of inhibitors against factor VIII and so will produce a false negative result in clotting based Bethesda assays for functional inhibition of factor VIII.
Danish: Emicizumab forbliver aktiv ved tilstedeværelse af faktor VIII-inhibitorer og vil derfor give et falsk-negativt resultat i koagulations-baserede Bethesda tests for funktionel hæmning af faktor VIII.
English: Only 6 patients had moderate hepatic impairment (1.5 × ULN < bilirubin ≤ 3 × ULN and any AST).
Danish: Kun 6 patienter havde moderat nedsat leverfunktion (1,5 × øvre normalgrænse < bilirubin ≤ 3 × øvre normalgrænse og enhver ASAT).
English: Using syringes and needles
Danish: Brug af sprøjter og nåle
English: A volume greater than 2 mL per injection should not be administered.
Danish: Der må ikke gives et volumen på mere end 2 ml pr. injektion.
English: Emicizumab bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective haemostasis.
Danish: Emicizumab danner bro mellem aktiveret faktor IX og faktor X og genopretter funktionen af den manglende aktiverede faktor VIII, der er nødvendig for effektiv hæmostase.
English: Emicizumab exhibited dose-proportional pharmacokinetics in patients with haemophilia A after the first dose of Hemlibra over a dose range from 0.3 to 6 mg/kg .
Danish: Emicizumab udviste, efter den første dosis af Hemlibra hos patienter med hæmofili A, dosis-proportionel farmakokinetik over et dosisinterval fra 0,3 til 6 mg/kg.
English: The impact of moderate and severe renal impairment on the pharmacokinetics of emicizumab cannot be concluded.
Danish: Påvirkningen af moderat og svært nedsat nyrefunktion på farmakokinetikken af emicizumab kan ikke konkluderes.
English: - Bethesda assays (bovine chromogenic) for FVIII inhibitor titers - Thrombin time (TT) - One-stage, prothrombin time (PT)-based, single-factor assays - Chromogenic-based single-factor assays other than FVIII1
Danish: - Bethesda test (bovine kromogenisk) for FVIII inhibitor titer - Trombintid (TT) - One-stage, protrombin tid (PT)-baseret, enkeltfaktor tests - Kromogen-baseret enkelt-faktor tests andre end FVIII1
English: ● Vial adapter (To be added on top of vial).
Danish: ● Hætteglasadapter (skal sættes på toppen af hætteglasset)
English: If aPCC is indicated in a patient receiving Hemlibra prophylaxis, the initial dose should not exceed 50 U/kg and laboratory monitoring is recommended (including but not restricted to renal monitoring, platelet testing, and evaluation of thrombosis).
Danish: Hvis aPCC er indiceret hos en patient i profylaktisk behandling med Hemlibra, bør startdosis ikke overstige 50 E/kg og laboratoriemonitorering anbefales (inklusive men ikke begrænset til nyrerne, blodplader og evaluering af trombose).
English: Option (For transfer of medicine from vial to syringe)
Danish: Valgmulighed (til overførsel af medicin fra hætteglas til sprøjte)
English: After proper training in subcutaneous injection technique, a patient may self-inject Hemlibra, or the patient's caregiver may administer it, if their physician determines that it is appropriate.
Danish: Patienten selv eller patientens omsorgsperson kan dog efter passende oplæring i subkutan injektionsteknik selv tage eller administrere Hemlibra, hvis lægen vurderer, at det er hensigtsmæssigt.
English: HRQoL for patients ages < 12 years was also evaluated at week 25 based on the Adapted InhibQoL with Aspects of Caregiver Burden questionnaire completed by caregivers (see Table 13).
Danish: Helbredsrelateret livskvalitet for patienter i alderen < 12 år blev også undersøgt ved uge 25 baseret på Adapted InhibQoL with Aspects of Caregiver Burden-spørgeskemaet, som er udfyldt af omsorgspersoner (se tabel 13).
English: If stored out of and then returned to refrigeration, the total combined time out of refrigeration should not exceed 7 days.
Danish: Hvis Hemlibra opbevares udenfor og derefter stilles tilbage i køleskabet, må den samlede tid uden for køleskabet ikke overskride 7 dage.
English: ● Keep the vial in the original box to protect the medicine from light.
Danish: ● Opbevar hætteglasset i den originale æske for at beskytte medicinen mod lys.
English: The patient/carer educational material should contain:
Danish: Uddannelsesmaterialet for patienter/omsorgspersoner skal indeholde:
English: Bleeds a Calculated with negative binomial regression (NBR) model b
Danish: Beregnet med negativ binomialregressions (NBR)-model b
English: Inspecting the medicine and your supplies:
Danish: Tjek medicinen og hjælpemidlerne:
English: ● destruction of red blood cells (thrombotic microangiopathy)
Danish: ● Ødelæggelse af røde blodlegemer (trombotisk mikroangiopati (TMA)
English: Despite limited experience with concomitant administration of anti-fibrinolytics with aPCC or rFVIIa in patients treated with Hemlibra, you should know that there may be a possibility of thrombotic events using anti-fibrinolytics administered intravenously in combination with aPCC or rFVIIa.
Danish: - På trods af begrænset erfaring med samtidig brug af anti-fibrinolytika med aPCC eller rekombinant faktor VIIa (rFVIIa) hos patienter som er i behandling med Hemlibra, bør du vide, at der kan være risiko for trombotiske hændelser ved anvendelse af anti-fibrinolytika givet intravenøst i kombination med aPCC eller rFVIIa.
English: The efficacy of Hemlibra for routine prophylaxis in patients with hemophilia A with or without FVIII inhibitors was evaluated in four clinical studies (three adult and adolescent studies [HAVEN 3, HAVEN 1, and HAVEN 4] and a paediatric study [HAVEN 2]).
Danish: Hemlibras virkning til rutinemæssig profylakse hos patienter med hæmofili A med eller uden FVIIIinhibitorer er undersøgt i fire kliniske studier (tre studier med voksne og unge (HAVEN 3, HAVEN 1 og HAVEN 4) og et pædiatrisk studie (HAVEN 2)).
English: This is because Hemlibra in the blood may interfere with some laboratory tests, leading to inaccurate results.
Danish: Når du har Hemlibra i blodet, kan det påvirke nogle af blodprøverne og give upræcise resultater.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: The paediatric population studied comprises a total of 107 patients, of which 5 (5 %) were infants and toddlers (1 month to less than 2 years of age), 55 (51 %) were children (from 2 to less than 12 years of age) and 47 (44 %) were adolescents (from 12 to less than 18 years old).
Danish: Den undersøgte pædiatriske population omfatter i alt 107 patienter, hvoraf 5 (5 %) var spædbørn og småbørn (aldersgruppen fra 1 måned til under 2 år), 55 (51 %) var børn (aldersgruppen fra 2 år til under 12 år) og 47 (44 %) var unge (aldersgruppen fra 12 år til under 18 år).
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
Danish: * Emicizumab er et humaniseret monoklonalt modificeret immunglobulin G4 (IgG4) antistof fremstillet ved brug af rekombinant DNA-teknologi i ovarieceller fra kinesisk hamster (CHO).
English: ● Stomach area (abdomen), except for 5 cm around the navel (belly button).
Danish: ● Maven, bortset fra et område på 5 cm rundt om navlen.
English: Table 1 Coagulation test results affected and unaffected by emicizumab
Danish: Tabel 1 Koagulationstestresultater, der påvirkes og ikke påvirkes af emicizumab
English: ● Blood clots (thromboembolism): swelling, warmth, pain or redness - these symptoms may be signs of a blood clot in a vein near the surface of the skin.
Danish: ● Blodpropper (tromboemboli): hævelser, varme, smerter eller rødme på huden - disse symptomer kan være tegn på en blodprop i en vene tæt på hudens overflade.
English: Physical health score (range 0 to 100)
Danish: Score for fysisk helbred (interval 0 til 100)
English: Such intrinsic pathway based tests will yield overly shortened clotting times with emicizumab, which does not require activation by thrombin.
Danish: Sådanne koagulationstests baseret på den interne koagulationsaktivering vil resultere i forkortede koagulationstider med emicizumab, som ikke kræver aktivering af trombin.
English: Most of the patients with hemophilia A in the population pharmacokinetic analysis had normal renal function (N = 332; creatinine clearance [CLcr] ≥ 90 mL/min) or mild renal impairment (N = 27; CLcr of 60-89 mL/min).
Danish: I den farmakokinetiske populationsanalyse havde de fleste patienter med hæmofili A normal nyrefunktion (N = 332, kreatinin-clearance (CLcr) ≥ 90 ml/min) eller let nedsat nyrefunktion (N = 27, CLcr på 60-89 ml/min).
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).
Danish: Studiet undersøgte farmakokinetik, sikkerhed og virkning, inklusive virkningen af ugentlig Hemlibraprofylakse sammenlignet med tidligere episodisk og profylaktisk behandling med lægemidler med bypassing aktivitet til patienter, der havde deltaget i non-interventionsstudiet inden inklusion (intra-patient-sammenligning).
English: Note: Ensure you have enough medicine in the syringe to complete your dose before moving on to the next step.
Danish: Bemærk: Du skal sikre dig, at du har nok medicin i sprøjten til at fuldføre din dosis inden du går videre til næste trin.
English: There is limited experience with bypassing agent or FVIII use during surgeries and procedures.
Danish: Der er begrænset erfaring med brug af lægemidler med bypassing aktivitet eller FVIII under kirurgiske og medicinske procedurer.
English: Seven patients previously treated with episodic (“on-demand”) bypassing agents who had participated in the NIS prior to enrolment but were unable to enroll in HAVEN 1 prior to the closure of Arms A and B were enrolled in Arm D to receive Hemlibra prophylaxis.
Danish: 7 patienter, som tidligere var behandlet episodisk (efter behov/on-demand) med lægemidler med bypassing aktivitet, og som havde deltaget i non-interventionsstudiet før inkludering, men ikke kunne inkluderes i HAVEN 1-studiet inden lukningen af arm A og B, blev inkluderet i arm D og fik Hemlibra-profylakse.
English: Adjust plunger to prescribed dose
Danish: Tilpas stemplet til den ordinerede dosis
English: Arm B) on the number of bleeds requiring treatment with coagulation factors over time (minimum of 24 weeks or date of discontinuation) (see Table 6).
Danish: Det primære endepunkt var antallet af blødningsepisoder med behov for behandling med lægemidler med bypassing aktivitet, over tid (mindst 24 uger eller dato for seponering) (se tabel 6).
English: Step E. Inject air into vial
Danish: Trin E. Sprøjt luft ind i hætteglasset
English: ● Your doctor will show you which areas of the body are suitable for injecting Hemlibra.
Danish: ● Lægen eller sygeplejersken vil vise dig hvilke steder på kroppen, der er egnede til at injicere Hemlibra.
English: Roche Austria GmbH Engelhorngasse 3 1211 Wien Austria
Danish: Roche Austria GmbH Engelhorngasse 3 1211 Wien Østrig
English: Do not use these instructions when using a transfer needle to withdraw Hemlibra from vial.
Danish: Du skal ikke bruge denne vejledning, hvis du bruger en overføringsnål til at trække Hemlibra op fra hætteglasset.
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.
Danish: I modsætning hertil er test, der indeholder bovine koagulationsfaktorer ikke følsomme over for emicizumab (ingen aktivitet målt) og kan anvendes til at monitorere endogen eller infunderet faktor VIII-aktivitet eller til at måle anti faktor VIII-inhibitorer.
English: Option (For transfer of HEMLIBRA from vial to syringe)
Danish: Valgmulighed (til overførsel af Hemlibra fra hætteglas til sprøjte)
English: Reminder to report any adverse events associated with the use of emicizumab.
Danish: Påmindelse om at rapportere eventuelle bivirkninger forbundet med brug af emicizumab
English: Population pharmacokinetics analyses in patients with haemophilia A showed that race did not affect the pharmacokinetics of emicizumab.
Danish: Farmakokinetiske populationsanalyser af patienter med hæmofili A har vist, at race ikke påvirker emicizumabs farmakokinetik.