FrancophonIA/ELRC3.0 huggingface dataset:
English: Some patients with haemophilia A can develop factor VIII inhibitors (antibodies against factor VIII) which stop the replacement factor VIII from working.
Danish: Nogle patienter med hæmofili A kan udvikle faktor VIII-inhibitorer (antistoffer mod faktor VIII), som stopper virkningen af erstatnings faktor VIII.
English: Only patients from the NIS were included in this comparison, because bleed and treatment data were collected with the same level of granularity as used in HAVEN 3.
Danish: Kun patienter fra non-interventionsstudiet blev inkluderet i denne sammenligning, da blødnings- og behandlingsdata blev indsamlet på samme måde som i HAVEN 3-studiet.
English: This is because you may be at risk of developing side effects such as blood clots.
Danish: Det er vigtigt fordi du kan få bivirkninger som for eksempel blodpropper.
English: ● If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: ● Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du bruger dette Hemlibra.
English: ADRs from the phase III clinical trials in patients who received Hemlibra are listed by MedDRA system organ class (Table 2).
Danish: Bivirkninger fra de kliniske fase III-studier med patienter behandlet med Hemlibra er opstillet efter MedDRA-systemorganklasse (tabel 2).
English: Haem-A_QoL scales range from 0 to 100; lower scores are reflective of better HRQoL.
Danish: Haem-A-QoL-scorer går fra 0 til 100; lavere scorer afspejler bedre helbredsrelateret livskvalitet.
English: Clinically meaningful difference: VAS: 7 points, Index Utility Score: 0.07 points
Danish: Klinisk betydningsfuld forskel: VAS: 7 point; IUS: 0,07 point.
English: Prior to launch of Hemlibra in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Indehaveren af markedsføringstilladelse skal aftale med de nationale myndigheder om indholdet og formatet af uddannelsesmaterialet, herunder kommunikationsmedier, distributionsmetoder og alle andre aspekter for materialet, før lancering af Hemlibra i hvert medlemsland.
English: Weekly Hemlibra prophylaxis showed a statistically significant and clinically meaningful improvement compared with no prophylaxis in the pre-specified endpoints of Haem-A-QoL Physical Health Scale score at the Week 25 assessment.
Danish: Ugentlig Hemlibra-profylakse viste statistisk signifikant og klinisk relevant forbedring sammenlignet med ingen profylakse for de præspecificerede endepunkter for Haem-A-QoL scoren for fysisk helbred efter vurdering ved 25 uger.
English: The HAVEN adult and adolescent clinical studies evaluated patient-reported hemophilia-related quality of life outcomes with the Haemophilia-Specific Quality of Life (Haem-A-QoL) questionnaire for adults (> 18 years) and its adolescent version (Haemo-QoL-SF, for 8 to <18 years),the Physical Health Score (i.e., painful swellings, presence of joint pain, pain with movement, difficulty walking far and needing more time to get ready) and Total Score (summary of all scores) were protocol defined endpoints of interest.
Danish: De kliniske HAVEN-studier med voksne og unge undersøgte patientrapporteret hæmofilirelateret livskvalitet resultater med Haemophilia-Specific Quality of Life (Haem-A-QoL)-spørgeskemaet for voksne (> 18 år) og versionen for unge (Haemo-QoL-SF, for 8 til < 18 år), scoren for fysisk helbred (dvs. smertefulde hævelser, tilstedeværelse af ledsmerter, smerte ved bevægelse, svært ved at gå langt og har brug for mere tid til at gøre sig klar) og totalscoren (sammenfatning af alle scorer), som var protokoldefinerede endepunkter af interesse.
English: Hemlibra is for subcutaneous use only, and it should be administered using appropriate aseptic technique (see section 6.6).
Danish: Hemlibra er udelukkende beregnet til subkutan brug og skal gives med passende aseptisk teknik (se pkt.
English: Store the vial in the refrigerator.
Danish: Opbevar hætteglasset i køleskabet.
English: Relative bioavailability decreased with older age, but no clinically important differences were observed in the pharmacokinetics of emicizumab between subjects < 65 years and subjects ≥ 65 years.
Danish: Den relative biotilgængelighed faldt ved højere alder, men der sås ingen klinisk betydningsfuld forskel i emicizumabs farmakokinetik mellem forsøgspersoner < 65 år og forsøgspersoner ≥ 65 år.
English: Following single subcutaneous injection in healthy subjects, the elimination half-life was approximately 4 to 5 weeks.
Danish: Efter subkutan enkeltinjektion i raske frivillige, var eliminationshalveringstiden ca. 4-5 uger.
English: The pharmacokinetics of emicizumab was determined via non-compartmental analysis in healthy subjects and using a population pharmacokinetic analysis on a database composed of 389 patients with haemophilia A.
Danish: Emicizumabs farmakokinetik er bestemt ved non-kompartmental analyse hos raske frivillige ved hjælp af en farmakokinetisk populationsanalyse af en database bestående af 389 patienter med hæmofili A.
English: Administration of Hemlibra subcutaneous injection in the upper outer arm should be performed by a caregiver or healthcare professional.
Danish: Subkutan injektion af Hemlibra udvendigt på overarmen skal udføres af en omsorgsperson eller af sundhedspersonale.
English: Do not use if the expiry date has passed.
Danish: De må ikke bruges, hvis udløbsdatoen er overskredet.
English: Emicizumab increases coagulation potential, therefore the FVIIa or FVIII dose required to achieve hemostasis may be lower than when used without Hemlibra prophylaxis.
Danish: Emicizumab øger koagulationspotentialet, og derfor kan den dosis FVIIa eller FVIII, der kræves for at opnå hæmostase, være lavere end ved anvendelse uden Hemlibra-profylakse.
English: ● If you do not have a sharps disposal container, you may use a household container that is: - made of heavy-duty plastic.
Danish: ● Hvis du ikke har en affaldsbeholder til skarpe genstande, kan du bruge en almindelig beholder, der: - er lavet af tykt plastic.
English: Description of the signs and symptoms of the following safety concerns and reminder of the importance of immediately stopping using Hemlibra and aPCC and notifying their treating physician if symptoms occur : - Destruction of red blood cells (thrombotic microangiopathy) - Blood clots (thromboembolism)
Danish: Beskrivelse af tegn og symptomer på følgende alvorlige sikkerhedsaspekter og påmindelse om vigtigheden af øjeblikkeligt at stoppe brug af Hemlibra og aPCC samt underrette den behandlende læge, hvis følgende symptomer opstår: - Ødelæggelse af røde blodlegemer (Trombotisk mikroangiopati (TMA)) - Blodprop (tromboemboli)
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.
Danish: Behandling bør startes under vejledning af en læge, der har erfaring med behandling af hæmofili og/eller blødningsforstyrrelser.
English: The amount of Hemlibra solution given in each injection must not be more than 2 mL
Danish: Mængde af Hemlibra opløsning, der gives i hver injektion, må ikke være mere end 2 ml.
English: ● Only use the vial once.
Danish: ● Hætteglasset må kun bruges én gang.
English: Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with
Danish: Hemlibra er indiceret som rutineprofylakse mod blødningsepisoder hos patienter med
English: Following subcutaneous administration in haemophilia A patients, the absorption half-life was 1.6 days.
Danish: Efter subkutan administration til hæmofili A-patienter, var absorptionshalveringstiden 1,6 dage.
English: Ctrough, ss (µg/mL) Cmax/Ctrough ratio
Danish: Cmiddelværdi, ss (µg/ml) Ctrough, ss (µg/ml) Cmax/Ctrough ratio
English: No data are available with respect to potential side effects of emicizumab on embryo-foetal development.
Danish: Der er ingen tilgængelige data med hensyn til potentielle bivirkninger af emicizumab i forhold til embryo-føtal udvikling.
English: Your doctor will consider the benefit of you taking Hemlibra against the risk to your baby.
Danish: Lægen vil vurdere om den gavn du har af Hemlibra opvejer risikoen for barnet.
English: What Hemlibra is
Danish: Hvad er Hemlibra
English: What you need to know before you use Hemlibra
Danish: Det skal du vide, før du begynder at bruge Hemlibra
English: There are no data in patients less than 1 year of age.
Danish: Der foreligger ingen data for patienter under 1 år.
English: The total volume of Hemlibra to be injected subcutaneously is calculated as follows: Total amount (mg) of emicizumab to be administered ÷ vial concentration (mg/mL) = total volume of Hemlibra (mL) to be injected.
Danish: Det totale volumen af Hemlibra, der skal injiceres subkutant, beregnes på følgende måde: Samlet mængde (mg) emicizumab, der skal gives, ÷ hætteglaskoncentration (mg/ml) = totalvolumen af Hemlibra (ml), der skal injiceres.
English: ● You should use an effective method of birth control (contraception) during treatment with Hemlibra and for 6 months after your last injection of Hemlibra.
Danish: ● Du skal anvende sikker prævention mens du er i behandling med Hemlibra og i seks måneder efter din sidste injektion med Hemlibra.
English: It is important to know the symptoms of such internal blood clots, in case they develop (see section 4, “Possible side effects” for a list of symptoms).
Danish: Det er vigtigt at kende symptomerne på blodpropper, hvis de skulle opstå (se afsnit 4, “Bivirkninger” for en liste over symptomer).
English: Storing Hemlibra vials, vial adapters, needles and syringes: ● Keep the vial in the original box to protect the medicine from light.
Danish: Opbevaring af Hemlibra hætteglas, hætteglasadaptere, nåle og sprøjter: ● Opbevar hætteglasset i den originale æske for at beskytte medicinen mod lys.
English: In the event of breakthrough bleeding, patients receiving emicizumab prophylaxis should be managed with available therapies.
Danish: I tilfælde af gennembrudsblødningsepisode skal patienter, der bliver behandlet med emicizumabprofylakse, behandles med tilgængelige behandlingsformer.
English: Once completed, keep the vial adapter onto the vial and return to Step 5 “Remove air bubbles”.
Danish: Når det er klaret, skal du lade hætteglasadapteren sidde på hætteglasset og vende tilbage til trin 5 ”Fjern luftbobler”.
English: The most commonly reported ISR symptoms were injection site erythema (11 %), injection site pain (4 %) and injection site pruritus (3 %).
Danish: De hyppigst indberettede symptomer ved injektionsstedet er erythem ved injektionsstedet (11 %), smerter ved injektionsstedet (4 %) og pruritus ved injektionsstedet (3 %).
English: What Hemlibra is used for
Danish: Hvad anvendes Hemlibra til
English: Assays containing human coagulation factors are responsive to emicizumab but may overestimate the clinical haemostatic potential of emicizumab.
Danish: Test der indeholder humane koagulationsfaktorer responderer på emicizumab, men kan overvurdere emicizumabs kliniske hæmostatiske potentiale.
English: ● Do not inject into areas that could be irritated by a belt or waistband.
Danish: ● Injektionen må ikke gives i områder, der kan være generet af et bælte eller lignende.
English: If FVIII is required in the perioperative period, please refer to section 4.5.
Danish: Hvis FVIII er påkrævet i den perioperative fase, henvises der til pkt.
English: This is because treatment with bypassing agents may need to change while receiving Hemlibra.
Danish: Dette skyldes at behandling med bypassing aktivitet kan kræve ændring, når du er i behandling med Hemlibra.
English: ● Do not inject yourself or someone else unless you have been shown how to by your healthcare provider.
Danish: ● Du skal ikke give dig selv eller andre injektionen, med mindre lægen eller sygeplejersken har vist dig, hvordan det gøres korrekt.
English: The primary objective of the study was to evaluate the efficacy of Hemlibra prophylaxis given every four weeks in maintaining adequate bleed control, based on treated bleeds.
Danish: Det primære formål med studiet var at undersøge effekten af Hemlibra-profylakse givet hver 4. uge til vedligeholdelse af tilstrækkelig kontrol af blødninger baseret på behandlede blødningsepisoder.
English: Intra-patient comparator data from the NIS.
Danish: Intra-patient-sammenligningsdata fra non-interventionsstudiet.
English: Table 11 HAVEN 2: Overview of efficacy (interim analysis)
Danish: HAVEN 2: Oversigt over effektresultater (interimanalyse)
English: For further information refer to the section “Disposing of the medicine and supplies”.
Danish: Hvis du vil vide mere, kan du læse afsnittet “Bortskaffelse af medicin og hjælpemidler”.
English: No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.
Danish: Ingen trombotiske mikroangiopati-hændelser eller trombotiske hændelser var forbundet med de resterende tilfælde af aPCC-behandling.
English: For injection, you can use your:
Danish: Til injektion kan du vælge:
English: ● Remove syringe cap (if required).
Danish: ● Fjern hætten på sprøjten (hvis nødvendigt).
English: If you cannot remove all medicine, turn the vial upright to reach the remaining amount
Danish: Hvis du ikke kan trække al medicinen op, kan du vende hætteglasset om for at få det sidste med
English: Hemlibra has no influence on the ability to drive and use machines.
Danish: Hemlibra påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: ● Do not throw away any used sharps disposal container in your household waste unless your local guidelines permit this.
Danish: ● Du må ikke smide affaldsbeholdere til skarpe genstande i skraldespanden med mindre det er tilladt ifølge de lokale retningslinjer.
English: Caution should be taken if intrinsic pathway clotting based laboratory tests are used, as misinterpretation of their results may lead to under-treatment of patients experiencing bleeding episodes, which can potentially result in severe or life-threatening bleeds.
Danish: Der skal udvises forsigtighed, hvis der anvendes koagulationstests baseret på intern koagulations aktivering, da fejlfortolkning af deres resultater kan føre til underbehandling af patienter, der oplever blødningshændelser, hvilket potentielt kan resultere i alvorlige eller livstruende blødninger.
English: Emicizumab can be administered interchangeably at these anatomical sites (see section 4.2).
Danish: Emicizumab kan injeceres ved alle disse anatomiske steder (se pkt.
English: ● Before opening the vial, read the vial label to make sure you have the correct medicine strength(s) to give the dose prescribed for you.
Danish: ● Inden du åbner hætteglasset skal du tjekke etiketten, så du er sikker på, at du har fået den rigtige medicinstyrke(er) til at give dig den dosis, der er ordineret til dig.
English: ● For each injection, use a different area of the body to the one you used last time.
Danish: ● For hver injektion, skal der vælges et andet sted, end det du brugte sidste gang.
English: There are no clinical studies of emicizumab use in pregnant women.
Danish: Der er ikke gennemført kliniske studier med emicizumab hos gravide kvinder.
English: In rare cases, a blood clot can form inside blood vessels and block them, which may be life-threatening.
Danish: I sjældne tilfælde kan en blodprop dannes i blodkar og blokere dette, hvilket kan være livstruende.
English: Physical health score (range 0 to 100)a
Danish: Score for fysisk helbred (interval 0 til 100)a
English: Similar to FVIII prophylaxis, self administration at home was allowed for all subsequent emicizumab doses.
Danish: I lighed med FVIII-profylakse, blev selvadministration derhjemme tilladt for alle efterfølgende emicizumab-doser.
English: ● Do not try to warm the vial by any other way.
Danish: ● Hætteglasset må ikke opvarmes på andre måder.
English: Due to its long half-life, these effects on coagulation assays may persist for up to 6 months after the last dose (see section 5.2).
Danish: På grund af emicizumabs lange halveringstid, kan disse påvirkninger af koagulationstest fortsætte i op til 6 måneder efter sidste dosis (se pkt.
English: ● You must inject Hemlibra only under the skin.
Danish: ● Du skal kun injicere Hemlibra under huden.
English: ● Make sure that you use a new injection needle for each injection and dispose of it after a single use.
Danish: ● Det er vigtigt, at du bruger en ny injektionsnål til hver injektion og smider den ud efter brug.
English: Haemophilia A is an inherited condition caused by a lack of factor VIII, an essential substance required for blood to clot and stop any bleeding.
Danish: Hæmofili A er en arvelig sygdom forårsaget af manglende faktor VIII, som er et essentielt stof, der kræves for at blodet kan størkne og stoppe en blødning.
English: Patients randomized to Arm B could switch to Hemlibra prophylaxis after completing at least 24 weeks without prophylaxis.
Danish: Patienterne, der blev randomiseret til arm B, kunne skifte til Hemlibra-profylakse efter gennemførelse af mindst 24 uger uden profylakse.
English: If you are not sure, talk to your doctor, pharmacist or nurse before using Hemlibra.
Danish: Hvis du er usikker, skal du kontakte lægen, apotekspersonalet eller sygeplejersken inden du bruger Hemlibra.
English: The MAH shall ensure that in each Member State where Hemlibra is marketed, all healthcare professionals, patients/carers who are expected to prescribe, dispense or use Hemlibra, and laboratory professionals, have access to/are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle sundhedspersoner og patienter/omsorgspersoner, som forventes at udskrive, give eller anvende Hemlibra samt laboratoriepersonale, har adgang til eller modtager følgende uddannelsesmateriale:
English: Do not remove the vial adapter from the clear plastic blister pack.
Danish: Tag ikke hætteglasadapteren ud af den klare blisterpakning.
English: ● Keep your fingers behind the safety shield and away from the needle at all times.
Danish: ● Hold altid dine fingre bag sikkerhedsskjoldet, væk fra nålen.
English: Bypassing agent or FVIII use during surgeries and procedures was determined by the investigator.
Danish: Brug af lægemidler med bypassing aktivitet eller FVIII under kirurgiske indgreb blev fastlagt af investigator.
English: The effect of age on the pharmacokinetics of emicizumab was assessed in a population pharmacokinetic analysis which included thirteen subjects aged 65 years and older (no subjects were older than 77 years of age).
Danish: Alderens betydning for emicizumabs farmakokinetik er undersøgt i en farmakokinetisk populationsanalyse, der inkluderede 13 forsøgspersoner i aldersgruppen 65 år og derover (ingen personer var ældre end 77 år).
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.
Danish: Cmiddelværdi, ss = middelværdi af koncentration ved steady-state; Cmax, ss = maksimale plasmakoncentration ved steady-state; Ctrough, ss = dal-koncentration ved steady-state.
English: At the time of the interim analysis, efficacy was evaluated in 59 patients who were < 12 years old and had been receiving weekly Hemlibra prophylaxis for at least 12 weeks, including four patients aged < 2 years old, 17 patients aged 2 to < 6 years, 38 patients aged 6 to < 12 years old.
Danish: Ved interimanalysen blev effekten undersøgt hos 59 patienter, som var < 12 år og var blevet behandlet med ugentlig Hemlibra-profylakse i mindst 12 uger, inklusive 4 patienter i alderen < 2 år, 17 patienter i alderen 2 til < 6 år og 38 patienter i alderen 6 til < 12 år.
English: Cmax, ss (µg/mL) Cavg, ss (µg/mL)
Danish: Cmax, ss (µg/ml)
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Hemlibra therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det bør besluttes, om patienten skal stoppe med at amme eller seponere/fravælge behandling med Hemlibra baseret på en vurdering af barnets gavn af amningen og moderens gavn af behandlingen.
English: The Haemo-QoL-SF is a valid and reliable measure of HRQoL.
Danish: Haemo-QoL-SF er en valid og pålidelig måling af helbredsrelateret livskvalitet.
English: The physician and the caregiver should determine the appropriateness of the child self-injecting Hemlibra.
Danish: Læge og omsorgsperson bør afgøre, om det er hensigtsmæssigt, at et barn selv foretager injektion af Hemlibra.
English: If bleeding is not controlled with the initial dose of aPCC up to 50 U/kg, additional aPCC doses should be administered under medical guidance or supervision with consideration made to laboratory monitoring for the diagnosis of TMA or thromboembolism and verification of bleeds prior to repeated dosing.
Danish: Kan blødningen ikke kontrolleres med en startdosis af aPCC på op til 50 E/kg, skal yderligere aPCC-doser gives under lægelig vejledning eller supervision, under hensynstagen til laboratorieovervågning til diagnosticering af TMA eller tromboembolisme og verificering af blødninger forud for gentagen dosering.
English: Preparing the syringe for injection:
Danish: Gør sprøjten klar til injektion:
English: Therefore, the dose of bypassing agent required may be lower than the dose you used before starting Hemlibra.
Danish: Derfor kan den dosis af lægemidler med bypassing aktivitet, du har brug for, være lavere, end den dosis du fik, før du begyndte behandling med Hemlibra.
English: Table 13 HAVEN 2: Change from baseline to week 25 in the Physical Health score of patients (< 12 years of age) following treatment with Hemlibra prophylaxis as reported by patients and caregivers
Danish: Tabel 13 HAVEN 2: Ændring fra baseline til uge 25 i scoren for fysisk helbred for patienter (i alderen < 12 år) efter behandling med Hemlibra-profylakse, som rapporteret af patienter og omsorgspersoner
English: - Treating physicians must carefully weigh the risk of TMA and thromboembolism against the risk of bleeding when considering aPCC treatment.
Danish: - Den behandlende læge skal nøje veje risikoen for TMA og tromboembolisme op imod risikoen for blødning hvis det overvejes at give aPCC
English: Treated spontaneous bleeds
Danish: Behandlede spontane blødningsepisoder
English: Similar pharmacokinetic profiles were observed following subcutaneous administration in the abdomen, upper arm, and thigh.
Danish: Tilsvarende farmakokinetiske profiler er observeret efter subkutan injektion i abdomen, overarm og lår.
English: Forty-nine patients previously treated with prophylactic bypassing agents were enrolled in Arm C to receive Hemlibra prophylaxis.
Danish: 49 patienter som tidligere var behandlet profylaktisk med lægemidler med bypassing aktivitet blev inkluderet i arm C for at få Hemlibra-profylakse.
English: INJECTION Step 7.
Danish: INJEKTION Trin 7.
English: Patients have had surgical procedures without discontinuing emicizumab prophylaxis in clinical trials.
Danish: Patienter har fået foretaget kirurgiske indgreb uden seponering af emicizumab-profylakse i kliniske forsøg.
English: ● If your prescribed dose is more than 2 mL, you will need to have more than one subcutaneous injection of Hemlibra; contact your healthcare provider for the injection instructions.
Danish: ● Hvis din ordinerede dosis er mere end 2 ml, er du nødt til at tage mere end én subkutan injektion med Hemlibra; spørg lægen eller sygeplejersken, hvordan du gør det.
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.
Danish: Efter gentagne subkutane injektioner i hæmofili A-patienter var den tilsyneladende clearance 0,272 l/dag og den tilsyneladende eliminationshalveringstid 26,8 dage.