FrancophonIA/ELRC3.0 huggingface dataset:
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).
Danish: 89 patienter, som tidligere var behandlet episodisk (efter behov/on-demand) med FVIII, blev randomiseret i forholdet 2:2:1 til Hemlibra administreret enten én gang om ugen (arm A, N = 36), hver 2. uge (arm B, N = 35) eller ingen profylakse (arm C, N = 18) stratificeret efter antallet af tidligere blødningsepisoder inden for de seneste 24 uger (< 9 eller ≥ 9).
English: The effect of age on the pharmacokinetics of emicizumab was assessed in a population pharmacokinetic analysis which included 5 infants (≥ 1 month to < 2 years), 55 children (less than 12 years) and 50 adolescents (12 to < 18 years) with haemophilia A. Age did not affect the pharmacokinetics of emicizumab in paediatric patients.
Danish: Alderens betydning for emicizumabs farmakokinetik er undersøgt i en farmakokinetisk populationsanalyse, der inkluderede 5 spædbørn (≥ 1 måned til < 2 år), 55 børn (under 12 år) og 50 unge (12 til < 18 år) med hæmofili A.
English: Alternating the site of injection may help prevent or reduce injection site reactions (see section 4.8).
Danish: Man kan forebygge eller reducere injektionsrelaterede reaktioner på administrationsstedet ved at skifte injektionssted (se pkt.
English: Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability in the emicizumab setting and warning that these tests should not be used to monitor for emicizumab activity, determine need for factor replacement dosing, or measure FVIII inhibitors.
Danish: Information om emicizumabs interaktion med visse laboratoriekoagulationstest, som vil påvirke deres pålidelighed ved brug af emicizumab og advarsel om, at disse tests ikke skal bruges til at måle emicizumab aktivitet, bestemme behovet for ændring af dosis for faktorbehandling eller måle FVIII-inhibitorer
English: ● blood clot in a vein behind your eye (cavernous sinus thrombosis)
Danish: ● blodprop i en vene bag øjet (kavernøs sinustrombose)
English: In the intra-patient analysis, Hemlibra weekly prophylaxis resulted in a clinical meaningful reduction (98 %) in treated bleed rate in 18 paediatric patients who had at least 12 weeks of Hemlibra prophylaxis compared to their bleed rate collected in the NIS prior to enrolment (Table 12).
Danish: I intra-patient-analysen medførte ugentlig profylaktisk behandling med Hemlibra en klinisk relevant reduktion (98 %) i behandlede blødningsepisoder hos 18 pædiatriske patienter, som havde mindst 12 ugers Hemlibra-profylakse-behandling sammenlignet med antallet af blødninger i non-interventionsstudiet, inden inklusion (se tabel 12).
English: ● Patient alert card
Danish: ● Patientkort
English: The exposure (Cavg, ss) of multiple doses is comparable between 1.5 mg/kg every week, 3mg/kg every 2 weeks and 6mg/kg dose every 4 weeks.
Danish: Eksponeringen (Cmiddelværdi, ss) af flere doser er sammenlignelig mellem en dosis på 1,5 mg/kg hver uge, 3 mg/kg hver 2. uge og 6 mg/kg hver 4. uge.
English: Emicizumab is a monoclonal antibody and is cleared via catabolism rather than renal excretion and a change in dose is not expected to be required for patients with renal impairment.
Danish: Emicizumab er et monoklonalt antistof og elimineres via katabolisme frem for udskillelse fra nyrerne og en dosisjustering forventes ikke at være nødvendig for patienter med nedsat nyrefunktion.
English: DISPOSAL Step 16.
Danish: BORTSKAFFELSE Trin 16.
English: These instructions are for use with the Vial Adapter only.
Danish: Denne brugsanvisning er kun til brug af en hætteglasadapter.
English: Instead, a chromogenic Bethesda assay utilising a bovine based factor VIII chromogenic test that is insensitive to emicizumab may be used.
Danish: stedet kan en kromogen Bethesda test med bovinbaseret faktor VIII-kromogen test anvendes, da denne ikke er følsom over for emicizumab.
English: No dose adjustments are recommended in patients with mild , renal or hepatic impairment (see section 5.2).
Danish: Det anbefales ikke at ændre dosis til patienter med let nedsat nyre- eller leverfunktion (se pkt.
English: Common: may affect up to 1 in 10 people
Danish: Almindelig: kan påvirke op til 1 ud af 10 patienter
English: The laboratory professional educational material should contain:
Danish: Uddannelsesmaterialet for sundhedspersonalet skal indeholde:
English: % reduction (RR)
Danish: % reduktion (rate ratio)
English: Previous bypassing agent treatment* (N = 18)
Danish: Tidligere behandling med lægemidler med bypassing aktivitet* (N = 18)
English: The predicted mean (±SD) Ctrough ,and Cmax and ratios of Cmax/Ctrough at steady- state for the recommended maintenance doses of 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks are shown in Table 14 .
Danish: Den forventede middelværdi (± standardafvigelse) af Ctrough, Cmax og ratioen for Cmax/Ctrough ved steadystate for de anbefalede vedligeholdelsesdoser på 1,5 mg/kg en gang om ugen, 3 mg/kg hver 2. uge eller 6 mg/kg hver 4. uge er vist i tabel 14.
English: Each vial of Hemlibra contains 60 mg (0.4 mL at a concentration of 150 mg/mL), 105 mg (0.7 mL at a concentration of 150 mg/mL) or 150 mg (1 mL at a concentration of 150 mg/mL) of emicizumab.
Danish: Hvert hætteglas med Hemlibra indeholder 60 mg (0,4 ml i en koncentration på 150 mg/ml), 105 mg (0,7 ml i en koncentration på 150 mg/ml) eller 150 mg (1ml i en koncentration på 150 mg/ml) emicizumab.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelig: kan påvirke op til 1 ud af 100 patienter
English: The safety and efficacy of emicizumab have not been formally evaluated in the surgical setting.
Danish: Virkningen og sikkerheden af emicizumab er ikke blevet undersøgt ved kirurgisk behandling.
English: Step B. Remove used vial adapter
Danish: Trin B. Fjern den brugte hætteglasadapter
English: Once removed from the refrigerator, unopened vials may be kept at room temperature (below 30°C) for up to 7 days.
Danish: Når det uåbnede hætteglas tages ud af køleskabet, kan det opbevares ved stuetemperatur (under 30°C) i op til 7 dage.
English: Treatment (including routine prophylaxis) with bypassing agents (e.g. aPCC and rFVIIa) should be discontinued the day before starting Hemlibra therapy (see section 4.4).
Danish: Behandling (inklusive rutineprofylakse) med lægemidler med bypassing aktivitet (fx aktiveret protrombin-kompleks-koncentrat (aPCC) og aktiveret rekombinant humant faktor VII (rFVIIa)) skal seponeres dagen før behandling med Hemlibra startes (se pkt.
English: From a microbiological point of view, once transferred from the vial to the syringe, the medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt, skal lægemidlet anvendes straks det er overført fra hætteglasset til sprøjten.
English: Emicizumab restores the tenase cofactor activity of missing activated factor VIII (FVIIIa).
Danish: Hemlibra gendanner tenase co-faktoraktiviteten af manglende aktiveret faktor VIII (FVIIIa).
English: The injection should be restricted to the recommended injection sites: the abdomen, the upper outer arms and the thighs (see section 5.2).
Danish: Injektionen skal kun gives i følgende anbefalede områder: maven, ydersiden af overarmen eller i låret (se pkt.
English: Emicizumab is a monoclonal antibody and cleared via catabolism rather than hepatic metabolism and a change in dose is not expected to be required for patients with hepatic impairment.
Danish: Emicizumab er et monoklonalt antistof og udskilles via katabolisme frem for metabolisme i leveren og en dosisjustering forventes ikke at være nødvendig for patienter med nedsat leverfunktion.
English: ● Slowly pull back the plunger and draw some air into the syringe.
Danish: ● Træk forsigtigt stemplet tilbage og træk luft ind i sprøjten.
English: ● The other ingredients are L-arginine, L-histidine, L-aspartic acid, poloxamer 188 and water for injections.
Danish: ● Øvrige indholdsstoffer er: L-arginin, L-histidin, L-asparaginsyre, Poloxamer 188 og vand til injektionsvæsker.
English: EQ-5D-5L scores after 24 weeks
Danish: EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L)-scorer efter 24 uger
English: Following multiple subcutaneous administrations of 3 mg/kg once weekly for the first 4 weeks in haemophilia A patients, mean (±SD) trough plasma concentrations of emicizumab achieved 52.6±13.6 µg/mL at Week 5.
Danish: Efter gentagne subkutane injektioner af 3 mg/kg, én gang ugentlig i de første 4 uger til hæmofili Apatienter, var de gennemsnitlige (± standardafvigelse) dal-plasmakoncentrationer af emicizumab 52,6±13,6 µg/ml ved uge 5.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Hemlibra weekly prophylaxis was evaluated in a single-arm, multicentre, open-label clinical study in paediatric patients (age < 12 years old, or 12 to 17 years old weighing < 40 kg) with haemophilia A with factor VIII inhibitors.
Danish: Ugentlig profylakse med Hemlibra blev undersøgt i et enkeltarmet, åbent, multicenter studie med pædiatriske patienter (alder < 12 år eller 12-17 år, vægt < 40 kg) med hæmofili A og faktor VIIIinhibitorer.
English: ● Guide for healthcare professionals
Danish: ● Vejledning for sundhedspersonalet
English: Physicians and patients/caregivers should weigh the benefits and risks of resuming Hemlibra prophylaxis following complete resolution of TMA on a case-by-case basis.
Danish: Læge og patient/omsorgsperson skal i hvert enkelt tilfælde afveje fordele og risici ved at genoptage profylakse med Hemlibra, når TMA er fuldstændig svunden.
English: ● Peel off back to open the blister pack.
Danish: ● Fjern beskyttelsesfolien for at åbne blisterpakningen.
English: Table 9 HAVEN 1: Change in Haem-A-QoL Physical Health and Total score with Hemlibra prophylaxis versus no prophylaxis in patients ≥ 18 years with factor VIII inhibitors
Danish: Tabel 9 HAVEN 1: Ændring i Haem-A-QoL-score for fysisk helbred og totalscore ved Hemlibra-profylakse versus ingen profylakse hos patienter ≥ 18 år med faktor VIIIinhibitorer
English: A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution, whereas a 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL.
Danish: Der skal anvendes en 1 ml sprøjte til injektioner op til 1 ml Hemlibraopløsning, og en 2-3 ml sprøjte til injektioner over 1 ml og op til 2 ml.
English: 2.INJECTION Step 6.
Danish: INJEKTION Trin 6.
English: ● Clean the chosen injection site area using an alcohol wipe.
Danish: ● Rengør det valgte injektionssted med en spritserviet.
English: Do not use the transfer needle to inject medicine as this may cause pain and bleeding 2.
Danish: Brug ikke overføringsnålen til at injicere medicinen, da det kan give smerter og blødning i huden.
English: Hemlibra subcutaneous injection should not be administered into areas where the skin is red, bruised, tender or hard, or areas where there are moles or scars.
Danish: Hemlibra subkutan injektion skal ikke gives på steder, hvor huden er rød, læderet, øm eller hård, eller hvor der er skønhedspletter eller ar.
English: - Immuno-based assays (e.g. ELISA, turbidimetric methods) - Genetic tests of coagulation factors (e.g.
Danish: - Immunbaserede test (fx ELISA, turbidimetriske metoder) - Genetiske test af koagulationsfaktorer (fx Factor V Leiden, Prothrombin 20210)
English: ● Syringes, transfer needles, vial adapters and injection needles are not provided in this pack.
Danish: ● Sprøjter, overføringsnåle, hætteglasadaptere og injektionsnåle følger ikke med i pakken.
English: Patients receiving Hemlibra prophylaxis should be monitored for the development of TMA when administering aPCC.
Danish: Patienter i profylaktisk behandling med Hemlibra skal monitoreres for udvikling af TMA, hvis der samtidig gives aPCC.
English: HAVEN 2 paediatric Efficacy Results (Interim Analysis)
Danish: Pædiatriske effektresultater (interimanalyse) fra HAVEN 2
English: Table 10 provides a summary of the comparison between the Hemlibra prophylaxis arm (Arm A) and the no prophylaxis arm (Arm B) on the EQ-5D-5L index utility scale and visual analog scale after 24 weeks of treatment adjusting for baseline.
Danish: Tabel 10 giver et resumé af sammenligningen mellem Hemlibra-profylakse-armen (arm A) og armen uden profylakse (arm B) på EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) index utility scale og visual analogue scale (VAS) efter 24 ugers behandling, justeret for baseline.
English: Inject air into vial
Danish: Sprøjt luft ind i hætteglasset
English: DISPOSAL Step 14.
Danish: BORTSKAFFELSE Trin 14.
English: Patients (aged ≥ 12 years old) with haemophilia A with or without factor VIII inhibitors (Study BO39182 - HAVEN 4)
Danish: Patienter (i alderen ≥ 12 år) med hæmofili A med eller uden faktor VIII-inhibitorer (studie BO39182HAVEN 4)
English: Step A. Insert new vial adapter into new vial
Danish: Trin A. Indsæt en ny hætteglasadapter på et nyt hætteglas
English: The overly shortened intrinsic clotting time will then disturb all single factor assays based on aPTT, such as the one stage FVIII activity assay (see section 4.4, Table 1).
Danish: Den forkortede interne koagulationstid vil derfor påvirke alle enkelt-faktortest baseret på aPTT, fx one-stage faktor VIII aktivitetstest (se pkt.
English: Modelling shows that less frequent dosing in patients with hypoalbuminemia and low body weight for their age results in lower emicizumab exposures; simulations indicate that these patients would still benefit from clinically meaningful bleed control.
Danish: Modellering viser, at mindre hyppig dosering hos patienter med hypoalbuminæmi og lav kropsvægt i forhold til deres alder, resulterer i lavere eksponering af emicizumab.
English: - can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out.
Danish: - kan lukkes tæt med punkteringsresistent låg og ikke noget sted kan gennemtrænges af skarpe genstande.
English: One patient resumed Hemlibra following resolution of thrombotic event and continued to be treated safely.
Danish: En patient genoptog Hemlibra behandlingen efter resolution af trombotisk hændelse og blev fortsat behandlet sikkert.
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.
Danish: ● Spritservietter Bemærk: Hvis du har brug for mere end 1 hætteglas for at få hele dosis, skal du bruge en ny spritserviet til hvert hætteglas.
English: Hemlibra should be inspected visually to ensure there is no particulate matter or discolouration prior to administration.
Danish: Hemlibra skal inden injektionen efterses for at sikre, at der ikke er partikler eller misfarvning.
English: Each vial of Hemlibra contains 30 mg (1 mL at a concentration of 30 mg/mL) of emicizumab.
Danish: Hvert hætteglas med Hemlibra indeholder 30 mg (1 ml i en koncentration på 30 mg/ml) emicizumab.
English: Remove vial cap and clean top
Danish: Fjern beskyttelseshætten fra hætteglasset og rengør toppen
English: In clinical trials, no cases of TMA or thrombotic events were observed with use of activated recombinant human FVII (rFVIIa) alone in patients receiving Hemlibra prophylaxis.
Danish: I de kliniske studier så man ingen tilfælde af TMA eller trombotiske hændelser i forbindelse med brug af rFVIIa alene hos patienter i profylakse med Hemlibra.
English: Warning on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and information that single-factor assays utilizing chromogenic or immuno-based methods are not affected by emicizumab and may be used to monitor coagulation parameters during treatment, with specific consideration for factor VIII chromogenic activity assays;
Danish: Advarsel om emicizumabs påvirkning af visse koagulationstests, som vil påvirke deres pålidelighed, samt information om at enkeltfaktor-test, der anvender kromogene eller immunbaserede metoder ikke påvirkes af emicizumab og kan anvendes til at monitorere koagulationsparametre under behandlingen, under særlig hensyntagen til faktor VIII kromogen aktivitetstest
English: Patient's bodyweight of 16 kg, under a maintenance dose regimen of 1.5 mg/kg once weekly:
Danish: Legemsvægt på 16 kg, vedligeholdelsesdosis på 1,5 mg/kg en gang om ugen:
English: In the study, patients received weekly Hemlibra prophylaxis (Arms A, C, and D) - 3 mg/kg once weekly for four weeks followed by 1.5 mg/kg once weekly thereafter - or no prophylaxis (Arm B).
Danish: I studiet fik patienterne ugentlig Hemlibra-profylakse (arm A, C og D) - 3 mg/kgen gang om ugen i 4 uger og herefter 1,5 mg/kg en gang om ugen - eller ingen profylakse (arm B).
English: Slowly push the plunger to push the large air bubbles out of the syringe.
Danish: Tryk forsigtigt stemplet opad for at presse luftboblerne ud af sprøjten.
English: ● Laboratory professionals educational material
Danish: ● Uddannelsesmateriale for laboratoriepersonalet
English: ● The guide for healthcare professionals shall contain the following key elements: Brief introduction to emicizumab (chemical class, mode of action, pharmacodynamics and indication)
Danish: Kort introduktion af emicizumab (kemisk gruppe, virkningsmekanisme, farmakodynamik og indikation)
English: Arm C: Hemlibra 1.5 mg/kg weekly
Danish: Arm C: Hemlibra 1,5 mg/kg ugentligt
English: Adults and Adolescents Efficacy Results
Danish: Effektresultater hos voksne og unge
English: ● Carefully pull the transfer needle cap straight off and away from your body.
Danish: ● Træk forsigtigt overføringsnålens hætte af ved at trække den lige af, væk fra din krop.
English: One patient resumed Hemlibra following resolution of TMA and continued to be treated safely.
Danish: En patient genoptog behandlingen med Hemlibra efter resolution af TMA og blev derefter fortsat behandlet sikkert med Hemlibra.
English: Patients received subcutaneous Hemlibra, 3 mg/kg once weekly for the first four weeks followed by either 1.5 mg/kg once weekly (Arms A and D) or 3 mg/kg every two weeks (Arm B) thereafter, or no prophylaxis (Arm C).
Danish: Patienterne fik Hemlibra subkutant 3 mg/kg en gang om ugen i de første 4 uger efterfulgt af enten 1,5 mg/kg en gang om ugen (arm A og D) eller 3 mg/kg hver 2. uge (arm B), eller ingen profylakse (arm C).
English: Stop using Hemlibra and aPCC, and talk to a doctor immediately if you or your caregiver notices any symptoms of blood clots in blood vessels.
Danish: Hold op med at bruge Hemlibra og aPCC og kontakt straks lægen, hvis du eller din omsorgsperson bemærker et eller flere symptomer på blodpropper.
English: ● Move the safety shield away from the needle and towards the syringe barrel.
Danish: ● Flyt sikkerhedsskjoldet væk fra nålen, ned mod sprøjten.
English: ● Polycarbonate with Luer-lock connection, sterile, fitting 15 mm vial neck outer diameter, single-use, latex-free and non-pyrogenic.
Danish: ● Polycarbonat med Luer lock forbindelse, steril, passer 15 mm hætteglas hals ydre diameter, engangsbrug, latex-fri og ikke-pyrogen.
English: The most serious adverse drug reactions (ADRs) reported from the clinical trials with Hemlibra were thrombotic microangiopathy (TMA) and thrombotic events, including cavernous sinus thrombosis (CST) and superficial vein thrombosis contemporaneous with skin necrosis (see below and section 4.4).
Danish: De mest alvorlige bivirkninger indberettet i kliniske studier med Hemlibra var TMA og trombotiske hændelser, inklusive kavernøs sinustrombose og overfladisk venøs tromboflebit ledsaget af hudnekrose (se nedenfor samt pkt.
English: The study also evaluated the efficacy of weekly Hemlibra prophylaxis compared with previous episodic (on-demand) and prophylactic bypassing agents (separate comparisons) in patients who had participated in the NIS prior to enrolment (Arms A and C, respectively) (see Table 7).
Danish: Studiet undersøgte også effekten af ugentlig Hemlibra-profylakse sammenlignet med tidligere episodisk (efter behov/on-demand) og profylaktisk behandling med lægemidler med bypassing aktivitet (separate sammenligninger) hos patienter, der havde deltaget i non-interventionsstudiet før inkludering (henholdsvis arm A og C) (se tabel 7).
English: Step D. Transfer medicine into syringe
Danish: Trin D. Overfør medicin til sprøjten
English: Hemlibra is a colourless to slightly yellow solution.
Danish: Hemlibra er en farveløs til let gullig opløsning.
English: ● Keep the needle in the vial and check the syringe for larger air bubbles.
Danish: ● Lad nålen blive i hætteglasset, mens du kontrollerer, om der er større luftbobler i sprøjten.
English: ● Discard vials that have been kept at room temperature for more than 7 days or have been in temperatures above 30°C.
Danish: ● Kassér hætteglas, der er opbevaret ved stuetemperatur i mere end 7 dage eller været opbevaret ved temperaturer over 30°C.
English: Treated target joint bleeds
Danish: Behandlede blødningsepisoder i target joints
English: In total three patients (0.8 %) in the clinical trials receiving Hemlibra prophylaxis withdrew from treatment due to ADRs, which were TMA, skin necrosis contemporaneous with superficial thrombophlebitis, and headache.
Danish: I de kliniske studier med Hemlibra-profylakse fik i alt tre patienter (0,8 %) seponeret behandling på grund af bivirkninger i form af TMA, hudnekrose samtidig med overfladisk tromboflebit samt hovedpine.
English: Management in the perioperative setting
Danish: Perioperativ håndtering
English: Patients (aged ≥ 12 years old and > 40 kg) with hemophilia A without FVIII inhibitors (Study BH30071 - HAVEN 3)
Danish: Patienter (i alderen ≥ 12 år og > 40 kg) med hæmofili A uden factor VIII-inhibitorer (studie BH30071
English: The most common ADRs reported in ≥ 10% of patients treated with at least one dose of Hemlibra were: injection site reactions (20 %), arthralgia (15 %) and headache (14 %).
Danish: Hemlibra var: reaktioner ved injektionsstedet (20 %), artralgi (15 %) og hovedpine (14 %).
English: ● Maintenance dose regimen: Week 5 and onwards: The dose is either 1.5 milligrams for every 1 kilogram you weigh, injected once a week, 3 milligrams for every 1 kilogram you weigh, injected every 2 weeks, or 6 milligrams for every 1 kilogram you weigh, injected every 4 weeks.
Danish: ● Vedligeholdelsesdosis, uge 5 og herefter: Dosis er enten 1,5 mg for hvert kg du vejer, injiceres én gang om ugen, 3 mg for hvert kg du vejer, injiceres hver 2. uge, eller 6 mg for hvert kg du vejer, injiceres hver 4. uge.
English: In the HAVEN 1 intra-patient analysis, Hemlibra prophylaxis resulted in statistically significant (p = 0.0003) and clinically meaningful reduction (79 %) in bleed rate for treated bleeds compared with previous bypassing agent prophylaxis collected in the NIS prior to enrolment (see Table 7).
Danish: I HAVEN 1 intra-patientanalysen resulterede Hemlibra-profylakse i en statistisk signifikant (p = 0,0003) og klinisk relevant reduktion (79 %) i forekomst af behandlede blødningsepisoder, sammenlignet med tidligere profylaktisk behandling med lægemidler med bypassing aktivitet registreret i non-interventionsstudiet før inklusion (se tabel 7).
English: No dose adjustments are recommended in patients ≥ 65 years of age (see sections 5.1 and 5.2).
Danish: Det anbefales ikke at justere dosis i aldersgruppen ≥ 65 år (se pkt.
English: Mean baseline score (95% CI) (n = 54) Mean change from baseline (95% CI) (n = 43)
Danish: Gennemsnitlig baseline score (95 % konfidensinterval) (N = 54) Gennemsnitlig ændring fra baseline (95 % konfidensinterval) (N = 43)
English: If you use more Hemlibra than you are supposed to, tell your doctor immediately.
Danish: Hvis du er kommet til at give en for stor dosis Hemlibra, skal du straks kontakte lægen.