FrancophonIA/ELRC3.0 huggingface dataset:
English: As with all therapeutic proteins, there is the potential for an immune response in patients treated with emicizumab.
Danish: Som med alle terapeutiske proteiner er der risiko for immunrespons, hos patienter som behandles med emicizumab.
English: Before you start using Hemlibra, it is very important to talk to your doctor about using “bypassing agents” (medicines that help blood clot but which work in a different way from factor VIII).
Danish: Inden du begynder at bruge Hemlibra, er det meget vigtigt, at du taler med lægen om brug af lægemidler med ”bypassing” aktivitet (lægemidler som hjælper blodet med at størkne, men som virker på en anden måde end faktor VIII).
English: It is not known whether emicizumab can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Danish: Det vides ikke, om emicizumab kan skade fostret, hvis det gives til en gravid kvinde, eller om det påvirker reproduktionsevnen.
English: Includes all instances of aPCC treatment excluding those in the first 7 days and those that occurred 30 days after the discontinuation of Hemlibra.
Danish: Inkluderer alle tilfælde af aPCC-behandling undtagen dem i de første 7 dage og dem, der forekom 30 dage efter ophør af Hemlibra-behandling.
English: Hemlibra can be used in all age groups.
Danish: Hemlibra kan anvendes af alle aldersgrupper.
English: In healthy subjects, the absolute bioavailability following subcutaneous administration of 1 mg/kg was between 80.4% and 93.1% depending on the injection site.
Danish: Hos raske frivillige var den absolutte biotilgængelighed efter subkutan injektion af 1 mg/kg mellem 80,4 % og 93,1 % afhængigt af injektionssted.
English: Each pack of Hemlibra contains 1 glass vial.
Danish: Hver pakning med Hemlibra indeholder 1 hætteglas.
English: Tell your doctor if you are using Hemlibra before you have laboratory tests to measure how well your blood is clotting.
Danish: Fortæl lægen, at du bruger Hemlibra inden du får taget blodprøver, der måler hvor godt dit blod størkner.
English: Only the first five emicizumab doses had to be administered under supervision to ensure safety and injection technique proficiency.
Danish: Emicizumab-doser skulle kun administreres under opsyn de første fem gange for at sikre sikkerhed og injektionstekniske færdigheder.
English: In some cases, this can cause damage to the kidneys and other organs.
Danish: I nogle tilfælde, kan nyrerne og/eller andre organer blive beskadiget.
English: Be cautious if you are at high risk for this condition (have had this condition in the past, or a member of your family have suffered from it), or if you are taking medicines that can increase the risk of developing this condition, such as ciclosporin, quinine or tacrolimus.
Danish: Vær forsigtig, hvis du har høj risiko for denne sygdom (hvis du tidligere har haft denne sygdom eller hvis et familiemedlem har haft den) eller hvis du tager medicin, der kan øge risikoen for at udvikle denne sygdom, som f.eks. ciclosporin, quinin eller tacrolimus.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2018
Danish: Dato for første markedsføringstilladelse: 23. februar 2018
English: ● Collect all supplies listed below to prepare and give your injection.
Danish: ● Sørg for, at du har alle de hjælpemidler, der er listet nedenfor, parat til at forberede og give injektionen.
English: ● a reaction in the area where the injection is given (redness, itching, pain)
Danish: ● en reaktion i det område, hvor injektionen er givet (rødme, kløe eller smerter)
English: Animal reproduction studies have not been conducted with Hemlibra.
Danish: Der er heller ikke gennemført dyre-reproduktionsstudier med Hemlibra.
English: The medicine prevents bleeding or reduces bleeding episodes in people with this condition.
Danish: Medicinen forhindrer blødning eller mindsker antallet af blødninger hos mennesker med denne lidelse.
English: In children less than one year of age, the blood system is still developing.
Danish: Blodsystemet er stadig under udvikling hos børn under et år.
English: Table 3 Characterisation of aPCC treatment* in the pooled phase III clinical studies
Danish: Tabel 3 Karakterisering af aPCC-behandling* i de poolede kliniske fase III-studier
English: No adequate or well-controlled drug-drug interaction studies have been conducted with emicizumab.
Danish: Der er ikke gennemført tilstrækkelige eller velkontrollerede lægemiddel-interaktionsstudier med emicizumab.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier indikerer ikke direkte eller indirekte skadelige virkninger i forhold til reproduktionstoksicitet (se pkt.
English: Includes data before up-titration only, for patients whose dose was up-titrated.
Danish: Inkluderer kun data før optitrering for patienter, hvis dosis blev optitreret.
English: Preclinical data reveal no special hazards for humans based on studies of acute and repeated dose toxicity, including safety pharmacology endpoints and endpoints for reproductive toxicity.
Danish: Prækliniske data har ikke vist særlig risiko for mennesker baseret på studier af akut toksicitet og toksicitet ved gentagne doser, inklusive farmakologiske sikkerheds-endepunkter og endepunkter for reproduktionstoksicitet.
English: The patient should then administer the next dose on the usual scheduled dosing day.
Danish: Den næste dosis skal patienten tage på den sædvanlige planlagte doseringsdag.
English: Effects of emicizumab on coagulation tests
Danish: Emicizumab´s virkninger på koagulationstest
English: The patient dose (in mg) and volume (in mL) should be calculated as follows:
Danish: Dosis (i mg) og volumen (i ml) skal beregnes på følgende måde:
English: You must read, understand and follow the Instructions for Use before injecting Hemlibra.
Danish: Du skal læse, forstå og følge brugsanvisningen, inden du bruger Hemlibra.
English: Dosage adjustments during treatment
Danish: Dosisændringer i løbet af behandlingen
English: Pharmacokinetic parameters derived from the population PK model.
Danish: Farmakokinetiske parametre stammer fra den farmakokinetiske populationsmodel.
English: Dose linearity
Danish: Dosis linearitet
English: ● Inspect the supplies for damage.
Danish: ● Tjek om hjælpemidlerne er beskadiget.
English: Less than 5 % of patients tested positive for anti-emicizumab antibodies and < 1 % of patients had anti-emicizumab antibodies with neutralizing potential (based on declining pharmacokinetics).
Danish: Færre end 5 % af patienterne blev testet positive for anti-emicizumab-antistoffer og < 1 % af patienterne havde anti-emicizumab-antistoffer med neutraliserende potentiale (baseret på faldende farmakokinetik).
English: The loading dose regimen is the same, irrespective of the maintenance dose regimen.
Danish: Opstartsdosis er den samme uanset vedligeholdelsesdosis.
English: Large air bubbles can reduce the dose you receive.
Danish: Store luftbobler kan reducere den dosis, du modtager.
English: The total aPCC dose should not exceed 100 U/kg in the first 24-hours of treatment.
Danish: Den totale dosis af aPCC må ikke overstige 100 E/kg i de første 24 timer af behandlingen.
English: Laboratory tests
Danish: Laboratorieundersøgelser
English: No studies have been conducted to assess the impact of emicizumab on milk production or its presence in breast milk.
Danish: Der er ikke gennemført studier med henblik på at vurdere emicizumabs betydning for mælkeproduktionen eller dets tilstedeværelse i modermælk.
English: It is not known whether emicizumab is excreted in human milk.
Danish: Det vides ikke om emicizumab udskilles i human mælk.
English: Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).
Danish: Det er vigtigt at klemme sammen om hudfolden for at sikre, at medicinen kommer ind under huden (i fedtvævet) og ikke dybere (i en muskel).
English: If bleeding does not stop, please contact your healthcare provider.
Danish: Hvis blødningen ikke stopper, skal du kontakte lægen.
English: You may need to use more than 1 vial to give yourself the correct dose.
Danish: Du kan have brug for mere end et hætteglas for at give dig selv den rigtige dosis.
English: Hemlibra should be used during pregnancy only if the potential benefit for the mother outweighs the potential risk to the fetus taking into account that, during pregnancy and after parturition, the risk for thrombosis is increased and that several pregnancy complications are linked to an increased risk for disseminated intravascular coagulation (DIC).
Danish: Hemlibra bør kun anvendes under graviditet, hvis den potentielle gavn for moderen opvejer den potentielle risiko for fostret og der skal tages højde for, at risikoen for trombose øges under graviditet og efter fødslen, og at flere graviditetskomplikationer er forbundet med en øget risiko for dissemineret intravaskulær koagulation (DIC).
English: ● Take the vial out of the refrigerator 15 minutes before use and allow it to reach room temperature (below 30°C) before preparing an injection.
Danish: ● Tag hætteglasset ud af køleskabet 15 minutter før brug, så medicinen kan opnå stuetemperatur (under 30°C) inden injektionen forberedes.
English: The vials should never be exposed to temperatures above 30 °C.
Danish: Hætteglassene må aldrig udsættes for temperaturer over 30°C.
English: Arm D patients could uptitrate after the second qualifying bleed.
Danish: Patienterne i arm D kunne optitrere efter den anden kvalificerende blødning.
English: ● If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for at least 10 seconds, until bleeding has stopped.
Danish: ● Hvis injektionsstedet bløder lidt, kan du presse en steril vatrondel eller et stykke gaze mod injektionsstedet i mindst 10 sekunder, indtil blødningen er stoppet.
English: The dose and duration of treatment with bypassing agents will depend on the location and extent of bleeding, and the patient's clinical condition.
Danish: Dosis og varighed af behandlingen med et lægemiddel med bypassing aktivitet vil afhænge af, hvor og hvor meget patienten bløder og af patientens kliniske tilstand.
English: Hemlibra can be used in adolescents and children of all ages.
Danish: Hemlibra kan bruges til unge og børn i alle aldre.
English: If you stop using Hemlibra
Danish: Hvis du holder op med at bruge Hemlibra
English: ● Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action.
Danish: ● Lav en hudfold på det valgte injektionssted, og stik nålen helt ind i hudfolden i en vinkel på 45° til 90° med en hurtig og fast bevægelse.
English: The patient should not take two doses on the same day to make up for a missed dose.
Danish: Patienten må ikke tage to doser på samme dag for at kompensere for en manglende dosis.
English: Following discontinuation of aPCC and interruption of Hemlibra, evidence of improvement or resolution was seen within one month (see section 4.8).
Danish: Efter seponering af aPCC og afbrydelse af Hemlibra var der tegn på bedring eller resolution inden for en måned (se pkt.
English: Chromogenic factor VIII activity tests may be manufactured with either human or bovine coagulation proteins.
Danish: Test til måling af kromogen faktor VIII aktivitet kan fremstilles med humane eller bovine koagulationsproteiner.
English: ● Once the syringe has been filled with the medicine, the injection must be given immediately.
Danish: ● Når sprøjten er fyldt med medicin, skal injektionen gives straks.
English: Parameters
Danish: Parametre
English: Of all instances of aPCC treatment, 68 % consisted of only one infusion < 100 U/kg.
Danish: 68 % af alle aPCC-behandlinger bestod af kun en infusion < 100 E/kg.
English: ● Your doctor or nurse will show you how to inject Hemlibra.
Danish: ● Lægen eller sygeplejersken vil vise dig hvordan du skal injicere Hemlibra.
English: Throw away any unused solution appropriately.
Danish: Ubrugt opløsning skal bortskaffes hensigtsmæssigt.
English: ● Once you have been trained, you should be able to inject this medicine at home, by yourself or with the help of a caregiver.
Danish: ● Når du er oplært i brugen af Hemlibra, kan du selv tage injektionen hjemme, eller med hjælp fra en omsorgsperson.
English: The median observation time for these patients was 29.6 weeks (range: 18.4 to 63.0 weeks).
Danish: Median observationstid for disse patienter var 29,6 uger (interval: 18,4 til 63,0 uger).
English: Average cumulative amount of aPCC over 24 hours (U/kg/24 hours)
Danish: Gennemsnitlig samlet mængde aPCC over 24 timer (E/kg/24 timer)
English: The mean exposure time (+SD) for all patients on study was 21.38 weeks (12.01).
Danish: Den gennemsnitlige eksponeringstid (+ standardafvigelse) for alle patienter i studiet var 21,38 uger (12,01).
English: b Efficacy data from treated patients aged < 12 years who had been on study HAVEN 2 for at least 12 weeks (N = 59), as the study aimed to primarily investigate treatment effect based on age.
Danish: Effektdata fra behandlede patienter i alderen < 12 år, som havde deltaget i HAVEN 2 i mindst 12 uger (N = 59), da studiet havde til formål primært at undersøge behandlingseffekt baseret på alder.
English: Do not inject two doses on the same day to make up for a forgotten dose.
Danish: Du må ikke tage to doser på samme dag, som erstatning for en glemt dosis.
English: There are limited data available on the use of Hemlibra in patients with moderate renal impairment (only 2 patients with CLcr of 30-59 mL/min) and no data in patients with severe renal impairment.
Danish: Der er begrænsede data tilgængelige om brug af Hemlibra til patienter med moderat nedsat nyrefunktion (kun 2 patienter med CLcr på 30-59 ml/min) og ingen data om patienter med svært nedsat nyrefunktion.
English: When people have this condition, the lining of the blood vessels can be damaged and blood clots may develop in small blood vessels.
Danish: Når man har denne tilstand, kan indersiden af blodårene blive beskadiget, og der kan udvikles blodpropper i de små blodkar.
English: Clinical studies in adults and adolescents
Danish: Kliniske studier hos voksne og unge
English: Do not use this medicine if it is cloudy, discoloured, or contains visible particles.
Danish: Brug ikke medicinen, hvis den er uklar, misfarvet eller indeholder synlige partikler.
English: ● or with severe haemophilia A who have not developed factor VIII inhibitors (the FVIII blood level is less than 1%).
Danish: ● eller med svær hæmofili A, som ikke har udviklet faktor VIII-inhibitorer (FVIII-blodniveauet er mindre end 1 %).
English: Emicizumab did not cause any changes in the reproductive organs of male or female cynomolgus monkeys up to the highest tested dose of 30 mg/kg/week (equivalent to 11 times the human exposure at the highest dose of 3 mg/kg/week, based on AUC).
Danish: Emicizumab har ikke forårsaget forandringer i han- og huncynomolgusabers reproduktive organer ved op til den højest testede dosis på 30 mg/kg/uge (svarende til 11 gange den humane eksponering ved den højeste dosis på 3 mg/kg/uge, baseret på AUC).
English: Pharmacotherapeutic group: antihemorrhagics, other systemic hemostatics; ATC code: B02BX06
Danish: Farmakoterapeutisk klassifikation: Hæmostatika, andre systemiske hæmostatika ATC-kode: B02BX06
English: ● Do not inject air into the medicine as this could create air bubbles in the medicine.
Danish: ● Sprøjt ikke luft ind i selve lægemidlet, da det kan give luftbobler i lægemidlet.
English: All patients were treated by hemophilia experts who confirmed that adequate FVIII propylaxis was administered to patients included in the intra-patient comparison, supporting equivalent usual prophylaxis care across sites and patients.
Danish: Alle patienter blev behandlet af hæmofili-eksperter, som bekræftede, at tilstrækkelig FVIII-profylakse blev administreret til patienter inkluderet i intra-patient-sammenligningen, og understøttede ækvivalent sædvanlig profylaksebehandling på tværs af behandlingssteder og patienter.
English: In this Study baseline Total Scores (mean = 41.14 and 44.58, respectively) and Physical Health scale scores (mean = 52.41 and 57.19, respectively) were similar for Hemlibra prophylaxis and no prophylaxis.
Danish: I dette studie var baseline totalscorer (henholdsvis gennemsnit = 41,14 og 44,58) og scoren for fysisk helbred (gennemsnit = 52,41 og 57,19) tilsvarende for Hemlibra-profylakse og uden profylakse.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl lægen eller apotekespersonalet, hvis du tager anden medicin, har gjort det for nylig eller planlægger at gøre det.
English: ● This medicine has been prescribed for you only.
Danish: ● Lægen har ordineret dette lægemiddel til dig personligt.
English: Injection site reactions (ISRs) were reported very commonly (20 %) from clinical trials.
Danish: Reaktioner på injektionsstedet er indberettet meget hyppigt (20 %) i de kliniske studier.
English: The dose of Hemlibra depends on your weight and your doctor will calculate the amount (in mg) and corresponding amount of Hemlibra solution (in mL) to be injected:
Danish: Din dosis af Hemlibra afhænger af din vægt og din læge vil beregne mængden (i mg) og den tilsvarende mængde Hemlibra opløsning (i ml), der skal injiceres:
English: Disposing of the medicine and supplies:
Danish: Bortskaffelse af medicin og hjælpemidler:
English: ● Repeat the steps above until you have removed the larger air bubbles.
Danish: ● Gentag ovenstående trin, indtil du har fjernet alle større luftbobler.
English: Treatment for the TMA events included supportive care with or without plasmapheresis and haemodialysis.
Danish: Behandlingen af disse tilfælde af TMA omfattede understøttende behandling med eller uden plasmaferese og hæmodialyse.
English: The median duration of exposure across the studies was 33 weeks (range: 0.1 to 94.3 weeks).
Danish: Median varighed af eksponering på tværs af studier var 33 uger (interval: 0,1 til 94,3 uger).
English: Annualized bleed rate and percent of patients with zero bleeds were calculated (see Table 11).
Danish: Den årlige blødningsrate og procent af patienter uden blødningsepisoder blev beregnet (se tabel 11).
English: ● Periodic safety update reports
Danish: ● Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: ● A child can self-inject the medicine provided the child's healthcare provider and the parent or caregiver agree.
Danish: ● Et barn kan selv injicere medicinen, hvis lægen og forældrene/barnets omsorgsperson er enige om, at det er hensigtsmæssigt.
English: The safety and efficacy of emicizumab in patients receiving ongoing immune tolerance induction have not yet been established.
Danish: Virkningen og sikkerheden af emicizumab hos patienter, der får vedvarende immuntolerance induktion, er endnu ikke blevet fastslagt.
English: The metabolism of emicizumab has not been studied.
Danish: Emicizumabs metabolisme er endnu ikke undersøgt.
English: ● fever
Danish: ● feber
English: Pediatric Health-Related Outcomes Results
Danish: Pædiatriske helbredsrelaterede resultater
English: ● Hemlibra is given by injection under the skin (subcutaneously).
Danish: ● Hemlibra gives som injektion under huden (subkutant).
English: ● Prepare and give the injection in clean and germ-free conditions using aseptic technique.
Danish: ● Klargør og giv injektionen under rene og bakteriefri forhold ved hjælp af en såkaldt aseptisk teknik.
English: No dosage adjustments of Hemlibra are recommended.
Danish: Det anbefales ikke at ændre dosis af Hemlibra.
English: Laboratory tests affected and unaffected by emicizumab are shown in Table 1 below.
Danish: Laboratorietest, som påvirkes og ikke påvirkes af emicizumab angives i tabel 1 nedenfor.
English: All ISRs observed in the Hemlibra clinical trials were reported as being non-serious and mild to moderate in intensity, and 95 % resolved without treatment.
Danish: Alle reaktioner på injektionsstedet, der er observeret i kliniske studier med Hemlibra, er indberettet som ikke-alvorlige og af let til moderat intensitet, og 95 % er svundet uden behandling.
English: Emicizumab is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure.
Danish: Emicizumab er et humaniseret monoklonalt modificeret immunglobulin G4 (IgG4) antistof med en bispecifik antistofstruktur.
English: If a patient misses a scheduled subcutaneous injection of Hemlibra, the patient should be instructed to take the missed dose as soon as possible, up to a day before the day of the next scheduled dose.
Danish: Hvis en patient har glemt en planlagt subkutan injektion af Hemlibra, skal patienten instrueres i at tage den manglende dosis så hurtigt som muligt og senest en dag før den næste planlagte dosis.
English: This medicine is not likely to affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at dette lægemiddel påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: To measure change in health status, the Index Utility Score (IUS) and the Visual Analog Scale (VAS) from the EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) was examined.
Danish: Til at måle ændring i helbredsstatus blev Index utility score (IUS) og Visual analogue scale (VAS) fra EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) undersøgt.
English: Patients with mild and moderate hepatic impairment were included in clinical trials.
Danish: Patienter med mild og moderat nedsat leverfunktion var inkluderet i kliniske studier.
English: No incompatibilities between Hemlibra and polypropylene or polycarbonate syringes , polycarbonate vial adapters and stainless steel needles have been observed.
Danish: Der er ikke observeret uforligeligheder mellem Hemlibra og polypropylen- eller polycarbonatsprøjter, polycarbonathætteglasadaptere og nåle af rustfrit stål.
English: Subcutaneous (under the skin) injection
Danish: Subkutan (under huden) injektion
English: If you inject Hemlibra yourself or if your caregiver injects it, you or your caregiver must carefully read and follow the instructions in section 7, “Instructions for use”.
Danish: Hvis du selv injicerer Hemlibra eller din omsorgsperson injicerer det, skal du eller din omsorgsperson omhyggeligt læse og følge vejledningen i afsnit 7, “Brugsanvisning”.
English: METHOD OF ADMINISTRATION Do not shake.
Danish: ADMINISTRATIONSMETODE Må ikke rystes
English: For each treatment arm, the mean exposure times (+SD) were 28.86 weeks (8.37) for Arm A, 8.79 (3.62) for Arm B, 21.56 (11.85) for Arm C and 7.08 (3.89) for Arm D. One patient in Arm A withdrew from study prior to initiation of Hemlibra.
Danish: For hver behandlingsarm var de gennemsnitlige eksponeringstider (+ standardafvigelse) 28,86 uger (8,37) for arm A, 8,79 (3,62) for arm B, 21,56 (11,85) for arm C og 7,08 (3,89) for arm D. En patient i arm A trak sig fra studiet før start af Hemlibra-behandling.
English: Do not throw the cap away.
Danish: Smid ikke nålehætten væk.
English: Reversible hemorrhage, perivascular mononuclear cell infiltration, degeneration/necrosis of subcutis and swelling of endothelium in the subcutis was noted in animals after subcutaneous injection.
Danish: Reversibel blødning, perivaskulær mononukleær celleinfiltration, degenerering/nekrose af underhuden og hævelse af endotel i underhuden blev registreret hos dyr efter subkutan injektion.
English: Thrombophlebitis superficial
Danish: Overfladisk tromboflebit
English: ● Monitoring using a FVIII chromogenic assay may guide the administration of coagulation factors, and testing for thrombophilic traits may be considered.
Danish: ● Monitorering ved brug af FVIII kromogent assay kan vejlede administrationen af koagulationsfaktorer og undersøgelse af trombofile karaktertræk kan overvejes.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler ved brug