FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Only use the syringes, transfer needles, and injection needles that your healthcare provider prescribes.
Danish: ● Brug kun de sprøjter, overføringsnåle og injektionsnåle, som lægen eller sygeplejersken anbefaler.
English: Hemlibra 150 mg/mL solution for injection
Danish: Hemlibra 150 mg/ml injektionsvæske, opløsning
English: No dedicated studies of the effect of renal impairment on the pharmacokinetics of emicizumab have been conducted.
Danish: Der er ikke gennemført studier med henblik på at undersøge om nedsat nyrefunktion påvirker emicizumabs farmakokinetik.
English: The efficacy results of HEMLIBRA prophylaxis compared with no prophylaxis with respect to rate of treated bleeds, all bleeds, treated spontaneous bleeds, treated joint bleeds, and treated target joint bleeds are shown in Table 4.
Danish: Effektresultaterne af Hemlibra-profylakse sammenlignet med ingen profylakse med hensyn til raten af behandlede blødningsepisoder, alle blødningsepisoder, behandlede spontane blødningsepisoder, behandlede blødningsepisoder i led samt behandlede blødningsepisoder i target joints er vist i tabel 4.
English: Colourless to slightly yellow solution.
Danish: Farveløs til svagt gullig opløsning.
English: Each mL of solution contains 150 mg of emicizumab* Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL.
Danish: Hemlibra 150 mg/ml injektionsvæske, opløsning Hver ml opløsning indeholder 150 mg emicizumab* Hvert hætteglas med 0,4 ml indeholder 60 mg emicizumab i en koncentration på 150 mg/ml.
English: ● Vial containing the medicine
Danish: ● Hætteglas med medicin
English: No dedicated studies on the effect of hepatic impairment on the pharmacokinetics of emicizumab have been conducted.
Danish: Der er ikke gennemført studier med henblik på at undersøge om nedsat leverfunktion påvirker emicizumabs farmakokinetik.
English: NAME OF THE MEDICINAL PRODUCT Hemlibra 150 mg/mL solution for injection emicizumab
Danish: LÆGEMIDLETS NAVN Hemlibra 150 mg/ml injektionsvæske, opløsning emicizumab
English: Primary analysis efficacy results of Hemlibra prophylaxis every four weeks with respect to rate of treated bleeds, all bleeds, treated spontaneous bleeds, treated joint bleeds, and treated target joint bleeds are shown in Table 8.
Danish: Effektresultaterne af primæranalysen for Hemlibra-profylakse hver 4. uge mht. raten af behandlede blødningsepisoder, alle blødningsepisoder, behandlede spontane blødningsepisoder, behandlede blødningsepisoder i led samt behandlede blødningsepisoder i target joints er vist i tabel 8.
English: The efficacy results of Hemlibra prophylaxis compared with no prophylaxis with respect to rate of treated bleeds, all bleeds, treated spontaneous bleeds, treated joint bleeds, and treated target joint bleeds are shown in Table 6.
Danish: Effektresultaterne af Hemlibra-profylakse sammenlignet med ingen profylakse mht. raten af behandlede blødningsepisoder, alle blødningsepisoder, behandlede spontane blødningsepisoder, behandlede blødningsepisoder i led samt behandlede blødningsepisoder i target joints er vist i tabel 6.
English: ● Maintenance dose (from week 5 on) example: 16 kg x 1.5 mg/kg = 24 mg of emicizumab needed for the maintenance dose.
Danish: ● Vedligeholdelsesdosis (fra uge 5 og frem) eksempel: 16 kg x 1,5 mg/kg = 24 mg emicizumab, der skal bruges til vedligeholdelsesdosis.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hemlibra 150 mg/mL solution for injection emicizumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Hemlibra 150 mg/ml injektionsvæske, opløsning emicizumab
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mg/1 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 150 mg/ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hemlibra 30 mg/mL solution for injection emicizumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Hemlibra 30 mg/ml injektionsvæske, opløsning emicizumab
English: ● Physician educational material
Danish: ● Uddannelsesmateriale for sundhedspersonalet
English: ● Only use the syringes, vial adapters, and injection needles that your healthcare provider prescribes.
Danish: ● Brug kun de sprøjter, hætteglasadaptere og injektionsnåle, som lægen eller sygeplejersken anbefaler.
English: Remove transfer needle
Danish: Fjern overføringsnålen
English: Hemlibra solution for injection vials are for single-use only.
Danish: Hætteglas med Hemlibra, opløsning til injektion, er kun til éngangsbrug.
English: A doctor qualified to care for patients with haemophilia will start you on treatment with Hemlibra.
Danish: Din behandling med Hemlibra vil blive startet op af en læge med erfaring i behandling af hæmofili.
English: ● The patient alert card shall contain the following key messages: Instructions for patients to carry the card at any time, including in conditions of emergency and to present the card at visits to doctors, hospital clinics, carers, laboratory professionals or pharmacists to inform on emicizumab treatment and risks; Information on serious, life-threatening thromboembolic events or thrombotic microangiopathy events that have been observed with the concomitant use of emicizumab with activated prothrombin complex concentrate (aPCC) in patients on emicizumab prophylaxis;
Danish: Vejledning til patienten om at have patientkortet på sig altid, herunder i nødstilfælde, og at vise det ved besøg hos læger, hospitaler, omsorgspersoner, laboratoriepersonale eller apotekspersonale for at informere om emicizumab-behandlingen og risici
English: ● With the syringe pointing upwards, slowly pull back the plunger to fill the syringe with more than the amount of medicine needed for your prescribed dose.
Danish: ● Mens sprøjten peger opad, skal du forsigtigt trække stemplet tilbage for at fylde sprøjten, indtil du har lidt mere medicin i sprøjten end den mængde du skal bruge.
English: It is important to know the symptoms of thrombotic microangiopathy, in case you develop the condition (see section 4, “Possible side effects” for a list of symptoms).
Danish: Det er vigtigt at kende symptomerne på TMA, hvis du skulle udvikle sygdommen (se pkt.
English: Information that they should be given a Patient Alert Card and reminder to carry it at all times and to show it to any healthcare professionals who may treat them; Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and on the importance to show the patient alert card to any healthcare professionals who may treat them and to laboratory professionals that will perform their coagulation testing;
Danish: Advarsel om emicizumabs påvirkning af visse koagulationstests, som vil påvirke deres pålidelighed, samt information om vigtigheden af at vise patientkortet til alle sundhedspersoner som behandler dem samt til laboratoriepersonalet, som udfører koagulationstests
English: How to use Hemlibra
Danish: Sådan skal du bruge Hemlibra
English: Arm A: Hemlibra 1.5 mg/kg weekly (N = 36)
Danish: Arm A: Hemlibra 1,5 mg/kg en gang om ugen (N = 36)
English: ● Remove the transfer needle from the syringe by twisting anticlockwise and gently pulling.
Danish: ● Fjern overføringsnålen fra sprøjten ved at dreje hætten med nål mod uret og trække forsigtigt i den.
English: % patients with 0 bleeds (95% CI)
Danish: % patienter med 0 blødningepisoder (95 % konfidensinterval)
English: Treated bleeds = bleeds treated with bypassing agents.
Danish: Behandlede blødningsepisoder = blødningsepisoder behandlet med lægemidler med bypassing aktivitet.
English: Hemlibra 30 mg/mL solution for injection
Danish: Hemlibra 30 mg/ml injektionsvæske, opløsning
English: Vial Adapter
Danish: Mave-tarm-kanalen
English: Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL.
Danish: Kriterier: Transparent polypropylen- eller polycarbonatsprøjte med Luer lock spids, med 0,01 mlinddeling.
English: The bypassing agent dose required may therefore be lower than that used without Hemlibra prophylaxis.
Danish: Hemlibra øger patientens koagulationspotentiale, og derfor kan den nødvendige dosis af et lægemiddel med bypassing aktivitet være lavere end den, man ville anvende uden Hemlibra-profylakse.
English: Each mL of solution contains 30 mg of emicizumab* Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hemlibra 30 mg/ml injektionsvæske, opløsning Hver ml opløsning indeholder 30 mg emicizumab* Hvert hætteglas med 1 ml indeholder 30 mg emicizumab i en koncentration på 30 mg/ml.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mg/1mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 30 mg/ml
English: Get ready:
Danish: Klargøring:
English: ● To calculate the volume to be administered divide calculated dose 360 mg by 150 mg/mL: 360 mg of emicizumab ÷ 150 mg/mL = 2.4 mL of 150 mg/mL Hemlibra concentration to be injected every four weeks.
Danish: ● For at beregne den volumen, der skal gives, divideres den beregnede dosis på 360 mg med 150 mg/ml: 360 mg emicizumab ÷ 150 mg/ml = 2,4 ml Hemlibra i en koncentration på 150 mg/ml, der skal injiceres hver 4. uge.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert 0,4 ml hætteglas indeholder 60 mg emicizumab i en koncentration på 150 mg/ml
English: % patients with zero bleeds (95% CI)
Danish: % patienter med 0 blødningsepisoder (95 % konfidensinterval)
English: ● Carefully pull the injection needle cap straightaway from the syringe.
Danish: ● Træk forsigtigt nålehætten af injektionsnålen ved at trække den væk fra sprøjten.
English: % Zero Bleeds (95% CI) bN = 59
Danish: cMedian årlig blødningsrate (interkvartilt interval, 25. percentil til 75. percentil) bN = 59
English: Do not recycle your used sharps disposal container.
Danish: Affaldsbeholderen til skarpe genstande må ikke genbruges.
English: Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL.
Danish: Kriterier: Transparent polypropylen- eller polycarbonatsprøjte med Luer lock spids, med 0,1 mlinddeling.
English: ● Remove and throw away the plastic blister pack.
Danish: ● Fjern blisterpakningen og kassér den.
English: Reminder to report any adverse events to their treating doctor.
Danish: Påmindelse om at rapportere alle bivirkninger til deres læge Uddannelsesmaterialet for laboratoriepersonalet skal indeholde:
English: ● Loading dose (first 4 weeks) example: 16 kg x 3 mg/kg = 48 mg of emicizumab needed for the loading dose.
Danish: ● Opstartsdosis (første 4 uger) eksempel: 16 kg x 3 mg/kg = 48 mg emicizumab, der skal bruges til opstartsdosis.
English: ● Remove the needle and syringe from the injection site at the same angle as inserted.
Danish: ● Træk nålen og sprøjten ud i samme vinkel, som du stak den ind i huden .
English: Most of the patients with haemophilia A in the population pharmacokinetic analysis had normal hepatic function (bilirubin and AST ≤ ULN, N = 300) or mild hepatic impairment
Danish: De fleste af patienterne med hæmofili A i den farmakokinetiske populationsanalyse havde normal leverfunktion (bilirubin og ASAT ≤ øvre normalgrænse, N = 300) eller let nedsat leverfunktion (bilirubin ≤ øvre normalgrænse og ASAT > øvre normalgrænse eller bilirubin fra 1,0 til 1,5 × øvre normalgrænse og enhver ASAT, N = 51).
English: What Hemlibra looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: If you use more Hemlibra than you should
Danish: Hvis du har brugt for meget Hemlibra
English: Treated Bleeds
Danish: Behandlede blødningsepisoder
English: 1.5 mg/kg once weekly 3 mg/kg every two weeks
Danish: 1,5 mg/kg en gang om ugen
English: ● Maintenance dose (from week 5 on) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the maintenance dose.
Danish: ● Vedligeholdelsesdosis (fra uge 5 og frem) eksempel: 40 kg x 3 mg/kg = 120 mg emicizumab, der skal bruges til vedligeholdelsesdosis.
English: The physician should immediately discontinue aPCC and interrupt Hemlibra therapy if clinical symptoms and/or laboratory findings consistent with TMA occur, and manage as clinically indicated.
Danish: Opstår der kliniske symptomer og/eller laboratoriefund svarende til TMA, skal lægen straks seponere aPCC og afbryde behandlingen med Hemlibra og igangsætte klinisk indiceret behandling.
English: Arm A: Hemlibra 1.5 mg/kg weekly (N=29)
Danish: Arm A: Hemlibra 1,5 mg/kg en gang om ugen (N = 29)
English: Physicians and patients/caregivers should weigh the benefits and risks of resuming Hemlibra prophylaxis following complete resolution of thrombotic events on a case-by-case basis.
Danish: Når den trombotiske hændelse er helt forsvundet, skal læge og patient/omsorgsperson, i hvert enkelt tilfælde afveje fordele og risici ved at genoptage profylaktisk behandling med Hemlibra.
English: Hemlibra is intended for use under the guidance of a healthcare professional.
Danish: Hvis Hemlibra skal gives af patienten selv og/eller af en omsorgsperson Hemlibra er beregnet til brug under vejledning af sundhedspersonale.
English: ● Keep the needle in the vial and turn the vial upside down.
Danish: ● Hold nålen i hætteglasset og vend hætteglasset om.
English: ● Followed by a maintenance dose of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks, from week 5 on: Patient bodyweight (kg) x dose (1.5; 3 or 6 mg/kg) = total amount (mg) of emicizumab to be administered
Danish: ● Efterfulgt af vedligeholdelsesdosis på enten 1,5 mg/kg en gang om ugen, 3 mg/kg hver 2. uge eller 6 mg/kg hver 4. uge, fra uge 5:
English: Check with your healthcare provider if you are not sure.
Danish: Tal med din hæmofililæge eller sygeplejerske, hvis du er i tvivl.
English: ● Keep vials, vial adapters, needles and syringes out of the sight and reach of children.
Danish: ● Opbevar hætteglas, hætteglasadaptere, nåle og sprøjter utilgængeligt for børn.
English: Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility as applicable) of the following safety concerns associated with the use of Hemlibra: - thromboembolic events associated with the concomitant use of emicizumab and activated prothrombin complex concentrate (aPCC), - thrombotic microangiopathy associated with the concomitant use of emicizumab and aPCC - life-threatening bleeding due to misinterpretation of the standard coagulation tests
Danish: Relevant information (såsom alvorligheden, sværhedsgraden, hyppigheden, tiden til fremkomst, reversibiliteten; hvis relevant) af de følgende sikkerhedsmæssige aspekter, som er associeret til anvendelse af Hemlibra:
English: Arm A: Hemlibra 1.5 mg/kg weekly (N=25)
Danish: Arm A: Hemlibra 1,5 mg/kg en gang om ugen (N = 25)
English: ● HEMLIBRA Instructions for Use
Danish: ● Brugsanvisning for Hemlibra
English: There is a possibility for hypercoagulability with rFVIIa or FVIII with emicizumab based on preclinical experiments.
Danish: Ud fra prækliniske eksperimenter er der en mulig risiko for hyperkoagulabilitet ved samtidig administration af rFVIIa eller faktor VIII (FVIII) og emicizumab.
English: ● Push and twist the transfer needle clockwise on to the syringe until it is fully attached.
Danish: ● Skub og drej overføringsnålen med uret på sprøjten, indtil den sidder helt fast.
English: ● Throw away the used vial/vial adapter into a sharps disposal container.
Danish: ● Smid det brugte hætteglas/hætteglasadapteren i affaldsbeholderen til skarpe genstande.
English: Bleed definitions adapted based on ISTH criteria
Danish: Blødningsdefinitioner tilpasset baseret på International Society of Thrombosis and Haemostasis (ISTH)kriterier.
English: ● Keep the vial adapter, injection needle and syringe dry.
Danish: ● Hætteglasadaptere, injektionsnåle og sprøjter skal holdes tørre.
English: Visual Analogue Scale Adjusted mean
Danish: Visual analogue scale (VAS) Justeret gennemsnit Forskelle i justeret gennemsnit (95 % konfidensinterval)
English: How Hemlibra is given
Danish: Sådan tages Hemlibra
English: When monitoring a patients underlying hemostatic activity, please refer to section 4.4 for laboratory tests unaffected by emicizumab.
Danish: 4.4 for laboratorietests, som ikke er påvirket af emicizumab.
English: Read the package leaflet before use Do not shake
Danish: Læs indlægssedlen inden brug
English: Treating physicians must carefully weigh the risk of TMA and thromboembolism against the risk of bleeding when considering aPCC treatment beyond a maximum of 100 U/kg in the first 24-hours.
Danish: Overvejer man at give mere aPCC end højest 100 E/kg i de første 24 timer, skal den behandlende læge nøje veje risikoen for TMA og tromboembolisme op imod risikoen for blødning.
English: Results Unaffected by emicizumab
Danish: Resultater, der påvirkes af emicizumab Resultater, der ikke påvirkes af emicizumab
English: ● Throw away any used vial(s), needles, vial or injection needle caps and used syringes in a sharps or puncture-proof container.
Danish: ● Smid brugte hætteglas, nåle, hætter fra nåle og hætteglas, og brugte sprøjter i en affaldsbeholder til skarpe genstande.
English: ● Push and twist the injection needle clockwise onto the syringe until it is fully attached.
Danish: ● Skub og drej sprøjten med uret ned på hætteglasadapteren indtil den sidder helt fast.
English: ● Loading dose (first 4 weeks) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the loading dose.
Danish: ● Opstartsdosis (første 4 uger) eksempel: 40 kg x 3 mg/kg = 120 mg emicizumab, der skal bruges til opstartsdosis.
English: Attach injection needle to syringe
Danish: Sæt injektionsnålen på sprøjten
English: ● Loading dose (first 4 weeks) example: 60 kg x 3 mg/kg = 180 mg of emicizumab needed for the loading dose.
Danish: ● Opstartssdosis (første 4 uger) eksempel: 60 kg x 3 mg/kg = 180 mg emicizumab, der skal bruges til opstartssdosis.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration of 150 mg/mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 0,7 ml indeholder 105 mg emicizumab i en koncentration på 150 mg/ml
English: ● To calculate the volume to be administered divide calculated dose 48 mg by 150 mg/mL: 48 mg of emicizumab ÷ 150 mg/mL = 0.32 mL of 150 mg/mL Hemlibra concentration to be injected.
Danish: ● For at beregne den volumen, der skal gives, divideres den beregnede dosis på 48 mg med 150 mg/ml: 48 mg emicizumab ÷ 150 mg/ml = 0,32 ml Hemlibra i en koncentration på 150 mg/ml, der skal injiceres.
English: ● The guide for patients/carers shall contain the following key messages: - What is emicizumab, how emicizumab has been tested, and how to use emicizumab; - Warning on the risks associated with the concomitant use of bypassing agents and Hemlibra and to discuss with their doctor if they are receiving activated prothrombin complex concentrate (aPCC) when being prescribed or while receiving Hemlibra;
Danish: ● Vejledningen for patienter/omsorgspersoner skal indeholde følgende hovedbudskaber: Hvad er emicizumab, hvordan er emicizumab blevet testet og hvordan bruges emicizumab
English: Injection site reactions
Danish: Almene symptomer og reaktioner på injektionsstedet
English: Table 8 HAVEN 4: Annualized Bleed Rate with Hemlibra prophylaxis in Patients ≥12 Years of Age with or without Factor VIII Inhibitors Hemlibra 6mg/kg Q4W
Danish: Tabel 8 HAVEN 4: Årlig blødningsrate ved Hemlibra-profylakse hos patienter ≥ 12 år medeller uden faktor VIII-inhibitorer
English: ● Injection needle with safety shield (Used to inject medicine).
Danish: ● Injektionsnål med sikkerhedsskjold (bruges til at injicere medicinen) Injektionsnålen må ikke bruges til at trække medicinen op af hætteglasset
English: Treated Target Joint Bleeds ABR (95% CI) % reduction (RR), p-value
Danish: Behandlede blødningsepisoder i target joints Årlig blødingsrate (95 % konfidensinterval) % reduktion (rate ratio), p-værdi
English: The physician should immediately discontinue aPCC and interrupt Hemlibra therapy if clinical symptoms, imaging, and/or laboratory findings consistent with thrombotic events occur, and manage as clinically indicated.
Danish: Opstår der kliniske symptomer, laboratoriefund eller billeddiagnostiske tegn på trombotiske hændelser, skal lægen straks seponere aPCC og afbryde behandlingen med Hemlibra og behandle patienten som klinisk indiceret.
English: Endpoints aABR (95% CI)
Danish: Endepunkt aÅrlig blødningsrate (95 % konfidensinterval)
English: ● To calculate the volume to be administered divide calculated dose 120 mg by 150 mg/mL: 120 mg of emicizumab ÷ 150 mg/mL = 0.8 mL of 150 mg/mL Hemlibra concentration to be injected every two weeks.
Danish: ● For at beregne den volumen, der skal gives, divideres den beregnede dosis på 120 mg med 150 mg/ml: 120 mg emicizumab ÷ 150 mg/ml = 0,8 ml Hemlibra i en koncentration på 150 mg/ml, der skal injiceres hver 2. uge.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 1 mL contains 150 mg of emicizumab at a concentration of 150 mg/mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 1 ml opløsning indeholder 150 mg emicizumab i en koncentration på 150 mg/ml
English: ● Remove the used vial adapter from the syringe by twisting anticlockwise and gently pulling.
Danish: ● Fjern den brugte hætteglasadapter fra sprøjten ved at dreje den mod uret og hive forsigtigt i den.
English: What Hemlibra contains
Danish: Hemlibra indeholder:
English: Adjusted mean
Danish: Justeret gennemsnit
English: ● To calculate the volume to be administered divide calculated dose 180 mg by 150 mg/mL: 180 mg of emicizumab ÷ 150 mg/mL = 1.20 mL of 150 mg/mL Hemlibra concentration to be injected.
Danish: ● For at beregne den volumen, der skal gives, divideres den beregnede dosis på 180 mg med 150 mg/ml: 180 mg emicizumab ÷ 150 mg/ml = 1,20 ml Hemlibra i en koncentration på 150 mg/ml, der skal injiceres.
English: ● Do not rub the injection site after injection.
Danish: ● Gnid ikke på huden, dér hvor injektionen er givet.
English: ● Keep the vial on the flat working surface and insert the transfer needle and syringe straight down into the centre of the vial stopper.
Danish: ● Stik overføringsnålen og sprøjten direkte ned i midten af gummiproppen på hætteglasset, der er placeret på en plan overflade.
English: ● Throw away any used caps, vial(s), vial adapters, needles and syringes in a sharps or puncture-proof container.
Danish: ● Smid brugte hætter, hætteglas, hætteglasadaptere, nåle og spøjter i en affaldsbeholder til skarpe genstande.
English: Hemlibra increases the patient's coagulation potential.
Danish: - Emicizumab øger patientens koagulationspotentiale, og derfor kan det være nødvendigt at justere dosis og varighed af en bypassing aktivitet.
English: % Zero Bleeds (95%CI)
Danish: % 0 blødningsepisoder (95 % konfidensinterval)
English: ● The Summary of Product Characteristics
Danish: ● Produktresuméet
English: ABR=Annualized Bleed Rate, CI=confidence interval; IQR=interquartile range; 25th percentile to 75th percentile
Danish: bMedian årlig blødningsrate (interkvartilt interval, 25. percentil til 75. percentil)
English: Injection needle
Danish: Injektionsnål
English: ABR= Annualised Bleed Rate; CI= confidence interval; RR= rate ratio; IQR= interquartile range, 25th percentile to 75th percentile, NA=Not Applicable
Danish: Median årlig blødningsrate (interkvartilt interval, 25. percentil til 75. percentil) % reduktion (rate ratio), p-værdi
English: The safety and efficacy of emicizumab have not been specifically tested in patients with hepatic impairment.
Danish: Der er ikke gennmført studier med henblik på at undersøge sikkerhed og effekt af emicizumab hos patienter med nedsat leverfunktion.
English: PREPARATION
Danish: Behandling
English: Breast-feeding
Danish: L-arginin
English: Step A. Recap transfer needle
Danish: Trin A. Sæt hætten tilbage på overføringsnålen
English: ● Slide the tip of the needle down so that it is within the medicine.
Danish: ● Træk nu sprøjten med nålen på lidt nedad, så nålespidsen kommer ned under væskeoverfladen.