FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains 37.3 mg sodium (main component of cooking/table salt) in each 20 mL vial.
Danish: Dette lægemiddel indeholder 37,3 mg natrium (hovedkomponenten i madlavnings-/bordsalt) i hvert hætteglas med 20 ml.
English: Eighteen percent (18%) of patients were refractory to a PI only, and 21% were refractory to bortezomib.
Danish: 18 % af patienterne var kun refraktære over for en PI; 21 % var refraktære over for bortezomib.
English: Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity (see section 4.4).
Danish: Det kan være nødvendigt at udsætte dosering for at give tid til gendannelse af blodlegemer i tilfælde af hæmatologisk toksicitet (se pkt.
English: Stringent complete response (sCR)
Danish: Stringent komplet respons (sCR)
English: When DARZALEX dosing was interrupted in the setting of ASCT (Study MMY3006) for a median of 3.75 (range: 2.4; 6.9) months, upon re-initiation of DARZALEX the incidence of IRRs was 11% at first infusion following ASCT.
Danish: Når dosering af DARZALEX blev afbrudt i forbindelse med ASCT (studie MMY3006) i et mediant antal måneder på 3,75 (interval: 2,4; 6,9), var forekomsten af infusionsrelaterede reaktioner efter genopstart af DARZALEX 11 % ved den første infusion efter ASCT.
English: • Grade 1-2 (mild to moderate): Once reaction symptoms resolve, the infusion should be resumed at no more than half the rate at which the IRR occurred.
Danish: • Grad 1-2 (let til moderat): Når symptomerne på reaktionen er forsvundet, skal infusionen genoptages ved en hastighed, der ikke må overstige halvdelen af den hastighed, ved hvilken IRR'en opstod.
English: Thirty-three percent (33%) of patients were refractory to an IMiD only, and 28% were refractory to lenalidomide.
Danish: 33 % af patienterne var kun refraktære over for et IMiD; 28 % var refraktære over for lenalidomid.
English: Patients should be typed and screened prior to starting daratumumab treatment.
Danish: Patienterne bør typebestemmes og screenes, før behandling med daratumumab indledes.
English: After each infusion of DARZALEX you will be given medicines (such as corticosteroids) to lower the chance of infusion-related reactions.
Danish: Efter hver infusion af DARZALEX vil du få lægemidler (f.eks. kortikosteroider) for at mindske risikoen for infusionsrelaterede reaktioner.
English: • If not used immediately, the diluted solution can be stored prior to administration for up to 24 hours at refrigerated conditions (2°C-8°C) and protected from light.
Danish: • Hvis infusionsvæsken ikke anvendes med det samme, kan den opbevares i op til 24 timer på køl (2 °C - 8 ºC) og beskyttet mod lys før administration.
English: 95% CI (%) Odds ratio with 95% CI MRD negativity in combination with CR or better c n(%)
Danish: 95 % CI (%) Oddsratio med 95 % CI MRD-negativitet i kombination med CR eller bedre c n (%)
English: The Guide for HCP and Blood Banks shall contain the following key elements:
Danish: Guiden til læger og blodbanker skal omfatte følgende nøgleelementer:
English: Dose adjustments for lenalidomide and dexamethasone were applied according to manufacturer's prescribing information.
Danish: Dosis af lenalidomid og dexamethason blev justeret i henhold til producentens ordineringsoplysninger.
English: The rates of engraftment and haematopoietic reconstitution was similar among the transplanted subjects in the D-VTd and VTd arms (D-VTd: 99.8%; VTd: 99.6%; as measured by the recovery of neutrophils > 0.5 x 10
Danish: Engraftment satser og hæmatopoietisk rekonstitution var sammenligneligt blandt transplanterede patienter i D-VTd-armen og VTd-armen (D-VTd: 99,8 %; VTd: 99,6 %, som målt ved restitution af neutrofiler > 0,5 x 10
English: Analysis 2 included 694 patients (n=326 for lenalidomide-dexamethasone; n=246 for bortezomib-dexamethasone; n=99 for pomalidomidedexamethasone; n=11 for bortezomib-melphalan-prednisone; and n=12 for bortezomib-thalidomidedexamethasone), Analysis 3 included 352 patients (bortezomib-melphalan-prednisone) and Analysis 4 included 355 patients (lenalidomide-dexamethasone).
Danish: Analyse 2 omfattede 694 patienter (n = 326 for lenalidomid-dexamethason, n = 246 for bortezomib-dexamethason, n = 99 for pomalidomid-dexamethason, n = 11 for bortezomib-melphalan-prednison og n = 12 for bortezomib-thalidomid-dexamethason), analyse 3 omfattede 352 patienter (bortezomib-melphalanprednison), og analyse 4 omfattede 355 patienter (lenalidomid-dexamethason).
English: In Study MMY1001, patients receiving daratumumab combination treatment (n=97) were administered the first 16 mg/kg daratumumab dose at Week 1 split over two days i.e. 8 mg/kg on Day 1 and Day 2 respectively.
Danish: I studiet MMY1001 fik patienter, som fik kombinationsbehandling med daratumumab (n = 97), administreret den første 16 mg/kg dosis i uge 1 fordelt på to dage, dvs. 8 mg/kg på henholdsvis dag 1 og dag 2.
English: Dyspnoea Pulmonary oedema
Danish: Dyspnø Pulmonalt ødem
English: Hepatitis B virus reactivation, in some cases fatal, has been reported in patients treated with DARZALEX.
Danish: Der er rapporteret om reaktivering af hepatitis B-virus, herunder dødelige tilfælde, hos patienter i behandling med DARZALEX.
English: DARZALEX can cause serious infusion related reactions (IRRs), including anaphylactic reactions (see section 4.8).
Danish: DARZALEX kan medføre alvorlige infusionsrelaterede reaktioner (IRR'er), herunder anafylaktiske reaktioner (se pkt.
English: • Calculate the dose (mg), total volume (mL) of DARZALEX solution required and the number of DARZALEX vials needed based on patient weight.
Danish: • Beregn dosis (mg), samlet volumen (ml) af DARZALEX-koncentrat og det nødvendige antal DARZALEX-hætteglas ud fra patientens vægt.
English: Dexamethasone 20 mg (or equivalent), administered prior to every DARZALEX infusion.
Danish: 20 mg dexamethason (eller ækvivalent) administreret før hver infusion af DARZALEX.
English: This is equivalent to 0.46% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 0,46 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: The median duration of response had not been reached in the DRd group and was 34.7 months (95% CI: 30.8, not estimable) in the Rd group.
Danish: Den mediane varighed af respons blev ikke nået i DRd-gruppen og var 34,7 måneder (95 % CI: 30,8, kan ikke estimeres) i Rd-gruppen.
English: • nerve damage that may cause tingling, numbness, or pain
Danish: • nerveskader, som kan medføre en snurrende fornemmelse i huden, følelsesløshed eller smerter
English: Results of an updated PFS analysis approximately 9 months after the original clinical cutoff, continued to show an improvement in PFS for patients in the DRd arm compared with the Rd arm.
Danish: Resultaterne af en opdateret PFS-analyse ca. 9 måneder efter den originale kliniske skæringsdato viste fortsat en forbedring i PFS for patienter i DRd-armen sammenlignet med Rd-armen.
English: This corresponds to 0.46% and 1.86% of the WHO recommended maximum daily intake of 2 g sodium for an adult, respectively.
Danish: Dette svarer til henholdsvis 0,46 % og 1,86 % af den WHO-anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: Women of child-bearing potential should use effective contraception during, and for 3 months after cessation of daratumumab treatment.
Danish: Kvinder i den fertile alder skal anvende sikker antikonception under og i 3 måneder efter seponering af daratumumab.
English: Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness.
Danish: Hvor det er relevant, er bivirkningerne inden for hver hyppighedsgruppe opstillet efter, hvor alvorlige de er.
English: No dose reduction of DARZALEX is recommended.
Danish: Det frarådes at reducere dosis af DARZALEX.
English: • sore throat, cough
Danish: • ondt i halsen, hoste
English: What you need to know before you are given DARZALEX
Danish: Det skal du vide, før du får DARZALEX
English: DARZALEX contains sodium
Danish: DARZALEX indeholder natrium
English: Forty percent had International Staging System (ISS) Stage I, 45% had ISS Stage II and 15% had ISS Stage III disease.
Danish: Fyrre procent havde International Staging System (ISS) stadie I, 45 % havde ISS stadie II, og 15 % havde ISS stadie III.
English: Incremental escalation of the infusion rate should be considered only in the absence of infusion reactions.
Danish: Infusionshastigheden bør kun overvejes at øges til næste trin ved fravær af infusionsrelaterede reaktioner.
English: The median duration of response had not been reached in the D-VMP group and was 21.3 months (range: 18.4, not estimable) in the VMP group.
Danish: Den mediane varighed af respons blev ikke nået i D-VMP-gruppen og var 21,3 måneder (interval:18,4, kan ikke estimeres) i VMP-gruppen.
English: The MAH shall ensure that in each MS where DARZALEX (daratumumab) is marketed, all HCPs and patients who are expected to prescribe, dispense and receive this product have access to/are provided with the below.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger og patienter i de enkelte medlemslande, hvor DARZALEX (daratumumab) markedsføres, som må forventes at ordinere, udlevere og modtage dette lægemiddel, har adgang til/får udleveret nedenstående.
English: Toxicology data have been derived from studies with daratumumab in chimpanzees and with a surrogate anti-CD38 antibody in cynomolgus monkeys.
Danish: Toksikologiske data er blevet udledt fra studier med daratumumab hos chimpanser og med et surrogat-anti-CD38-antistof hos cynomolgusaber.
English: Bortezomib is given twice weekly at Weeks 1, 2, 4 and 5 for the first 6-week cycle, followed by once weekly at Weeks 1, 2, 4 and 5 for eight more 6-week cycles.
Danish: Bortezomib gives hver anden uge i uge 1, 2, 4 og 5 i den første 6-ugers serie, efterfulgt af en gang om ugen i uge 1, 2, 4 og 5 i yderligere otte 6-ugers serier.
English: DARZALEX infusion should be interrupted for IRRs of any severity and medical management/supportive treatment for IRRs should be instituted as needed.
Danish: Infusion af DARZALEX skal afbrydes ved alle IRR'er uanset sværhedsgrad, og der skal iværksættes medicinsk behandling/understøttende behandling af alle IRR'er efter behov.
English: DARZALEX is also supplied as an initiation pack containing 11 vials: (6 x 5 mL vials + 5 x 20 mL vials).
Danish: DARZALEX leveres også som en startpakke, der indeholder 11 hætteglas (6 x 5 ml hætteglas + 5 x 20 ml hætteglas).
English: To reduce the risk of delayed IRRs, oral corticosteroids should be administered to all patients following DARZALEX infusions.
Danish: For at reducere risikoen for forsinkede IRR'er skal alle patienter have orale kortikosteroider efter infusion af DARZALEX.
English: There is no known specific antidote for daratumumab overdose.
Danish: Der findes ingen specifik antidot til daratumumab.
English: An odds ratio >1 indicates an advantage for DRd.
Danish: En oddsratio > 1 indikerer en fordel for DRd.
English: Decreased blood cell counts
Danish: Nedsat antal blodlegemer
English: Constipation Nausea Vomiting Pancreatitis
Danish: Forstoppelse Kvalme Opkastning Pancreatitis
English: Additionally, for patients with a history of chronic obstructive pulmonary disease, the use of post-infusion medications including short and long acting bronchodilators, and inhaled corticosteroids should be considered.
Danish: Desuden skal det overvejes at give patienter med kronisk obstruktiv lungesygdom i anamnesen lægemidler efter infusionen som f.eks. bronkodilatorer med kort og lang virkningstid samt inhalationskortikosteroider.
English: Pre-infusion medications should be administered to reduce the risk of IRRs to all patients 1-3 hours prior to every infusion of DARZALEX as follows:
Danish: For at reducere risikoen for IRR'er skal alle patienter præmedicineres 1-3 timer før hver infusion af DARZALEX på følgende måde:
English: • Corticosteroid (long-acting or intermediate-acting) - Monotherapy:
Danish: • Kortikosteroid (med lang eller mellemlang virkningsvarighed) Monoterapi:
English: Week 25 onwards until disease progression b every four weeks
Danish: Uge 25 og frem, indtil sygdomsprogression hver fjerde uge
English: The HCPs and Blood Banks educational materials, shall contain the following key elements:
Danish: Uddannelsesmaterialet til læger og blodbanker skal indeholde følgende nøgleelementer:
English: • Do not store any unused portion of the infusion solution for reuse.
Danish: • Ikke anvendt infusionsvæske må ikke gemmes til senere brug.
English: Pre- and post-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) with daratumumab.
Danish: Der skal administreres lægemidler før og efter infusion for at reducere risikoen for infusionsrelaterede reaktioner (IRR'er) med daratumumab.
English: The mean (SD) predose (trough) serum concentration at the end of weekly dosing was 573 (331.5) micrograms/mL.
Danish: Den gennemsnitlige (SD) serumkoncentration før dosering (dalværdi) efter afslutning af ugentlig dosering var 573 (331,5) mikrogram/ml.
English: At the end of weekly dosing for the recommended monotherapy schedule and dose of 16 mg/kg, the mean (SD) serum Cmax value was 915 (410.3) micrograms/mL, approximately 2.9-fold higher than following the first infusion.
Danish: Efter afslutning af ugentlig dosering i henhold til det anbefalede monoterapi-doseringsskema og den anbefalede dosis på 16 mg/kg var den gennemsnitlige (SD) Cmax i serum 915 (410,3) mikrogram/ml, hvilket var omtrent 2,9 gange højere end efter den første infusion.
English: You and your doctor will decide if the benefit of breastfeeding is greater than the risk to your baby.
Danish: Du og din læge skal beslutte, om fordelene for barnet ved amning er større end risikoen.
English: Three additional population PK analyses (Analysis 2, Analysis 3 and Analysis 4) were conducted in patients with multiple myeloma that received daratumumab combination therapies.
Danish: Der blev gennemført yderligere tre farmakokinetiske populationsanalyser (analyse 2, analyse 3 og analyse 4) hos patienter med myelomatose, som fik kombinationsbehandling med daratumumab.
English: 200 mL/hour
Danish: 200 ml/time
English: It should be recognised that daratumumab bound to RBCs may mask detection of antibodies to minor antigens in the patient's serum.
Danish: Det skal bemærkes, at daratumumab bundet til erytrocytter kan maskere påvisning af antistoffer mod minor antigener i patientens serum.
English: At a survival update with a median duration of follow-up of 14.7 months, median Overall Survival (OS) was 17.5 months (95% CI:13.7, not estimable).
Danish: Ved en opdatering vedrørende overlevelse efter en median opfølgningsvarighed på 14,7 måneder var den mediane samlede overlevelse (OS) 17,5 måneder (95 % CI: 13,7; kan ikke estimeres).
English: DARZALEX therapy should be discontinued immediately and permanently (see sections 4.2 and 4.3).
Danish: DARZALEX-behandling skal seponeres straks og permanent (se pkt.
English: In responders, the median time to response was 1.05 months (range: 0.2 to 12.1 months) in the DRd group and 1.05 months (range: 0.3 to 15.3 months) in the Rd group.
Danish: Hos patienter med respons var mediantiden til respons 1,05 måneder (interval: 0,2 til 12,1 måneder) i DRd-gruppen og 1,05 måneder (interval: 0,3 til 15,3 måneder) i Rd-gruppen.
English: Stringent complete response (sCR) Complete response (CR)
Danish: Stringent komplet respons (sCR) Komplet respons (CR)
English: • Using aseptic technique, remove a volume of 0.9% Sodium Chloride from the infusion bag/container that is equal to the required volume of DARZALEX solution.
Danish: • Ved hjælp af aseptisk teknik fjernes et volumen 0,9 % natriumchlorid fra infusionsposen/-beholderen svarende til det volumen DARZALEX-koncentrat, der skal bruges.
English: Prior therapies included bortezomib (99%), lenalidomide (99%), pomalidomide (63%) and carfilzomib (50%).
Danish: Tidligere behandlinger inkluderede bortezomib (99 %), lenalidomid (99 %), pomalidomid (63 %) og carfilzomib (50 %).
English: • The other ingredients are glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride and water for injections (see “DARZALEX contains sodium” in section 2).
Danish: • Øvrige indholdsstoffer: koncentreret eddikesyre, mannitol (E421), polysorbat 20, natriumacetattrihydrat, natriumchlorid og vand til injektionsvæsker (se ”DARZALEX indeholder natrium” i afsnit 2).
English: To facilitate administration, the first prescribed 16 mg/kg dose at Week 1 may be split over two consecutive days i.e. 8 mg/kg on Day 1 and Day 2 respectively, see Table 5 below.
Danish: For at lette administrationen kan den første ordinerede dosis på 16 mg/kg i uge 1 fordeles på to på hinanden følgende dage, dvs. 8 mg/kg på henholdsvis dag 1 og dag 2.
English: At baseline, 76% of patients were refractory to the last line of treatment, 64% were refractory to both a PI and IMiD, 60% were refractory to alkylating agents, 36% were refractory to pomalidomide and 17% were refractory to carfilzomib.
Danish: Ved baseline var 76 % af patienterne resistente over for den sidste behandlingslinje, 64 % var resistente over for både en PI og et IMiD, 60 % var resistente over for alkylerende midler, 36 % var resistente over for pomalidomid, og 17 % var resistente over for carfilzomib.
English: Daratumumab has been shown to potently inhibit the in vivo growth of CD38-expressing tumour cells.
Danish: Det er påvist, at daratumumab er en potent hæmmer af vækst in vivo af CD38-udtrykkende tumorceller.
English: At a survival update with a median duration of follow-up of 15.2 months, median OS was not reached (95% CI: 19.9 months, not estimable), with 74% of subjects still alive.
Danish: Ved en opdatering vedrørende overlevelse efter en median opfølgningsvarighed på 15,2 måneder blev den mediane OS ikke nået (95 % CI: 19,9 måneder; kan ikke estimeres), og 74 % af forsøgspersonerne var stadig i live.
English: Sixty-nine percent (69%) of patients had received a prior PI (66% received bortezomib) and 76% of patients received an IMiD (42% received lenalidomide).
Danish: 69 % af patienterne havde tidligere fået en PI (66 % havde fået bortezomib), og 76 % af patienterne havde fået et IMiD (42 % havde fået lenalidomid).
English: The median time to onset of a reaction was 1.5 hours (range: 0 to 72.8 hours).
Danish: Mediantiden til indtræden af en reaktion var 1,5 timer (interval: 0 til 72,8 timer).
English: • build up of fluid in the lungs making you short of breath
Danish: • ophobning af væske i lungerne, så du bliver kortåndet
English: Option 2 (Split dose infusion) Week 1 Day 1 (8 mg/kg)
Danish: Mulighed 2 (infusion af en opdelt dosis) Uge 1, dag 1 (8 mg/kg)
English: Excipients: glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride, water for injections.
Danish: Hjælpestoffer: koncentreret eddikesyre, mannitol (E421), polysorbat 20, natriumacetattrihydrat, natriumchlorid, vand til injektionsvæsker.
English: Following the start of daratumumab treatment, none of the monotherapy patients and 2 of the 1051 combination therapy patients tested positive for anti-daratumumab antibodies; 1 of the combination therapy patients developed transient neutralising antibodies against daratumumab.
Danish: Efter indledning af behandling med daratumumab blev ingen af patienterne på monoterapi og 2 af de 1.051 patienter på kombinationsterapi testet positive for anti-daratumumab-antistoffer; 1 patient på kombinationsterapi udviklede forbigående neutraliserende antistoffer mod daratumumab.
English: Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to the CD38 protein expressed at a high level on the surface of multiple myeloma tumour cells, as well as other cell types and tissues at various levels.
Danish: Daratumumab er et humant monoklonalt IgG1κ-antistof (mAb), som binder til CD38-proteinet, der er udtrykt på højt niveau på overfladen af myelomatose-tumorceller og på forskellige niveauer på andre celletyper og væv.
English: HBV screening should be performed in all patients before initiation of treatment with DARZALEX.
Danish: Alle patienter skal screenes for HBV, før der iværksættes behandling med DARZALEX.
English: Before each infusion of DARZALEX you will be given medicines which help to lower the chance of infusion-related reactions.
Danish: Før hver infusion af DARZALEX vil du få lægemidler, som kan hjælpe med at mindske risikoen for infusionsrelaterede reaktioner.
English: ) NK cells in peripheral whole blood and bone marrow were observed with daratumumab treatment.
Danish: ) i perifert fuldblod og knoglemarv ved behandling med daratumumab.
English: Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods.
Danish: Metoder til at mindske daratumumab-interferens omfatter behandling af reagens-erytrocytter med dithiothreitol (DTT) for at bryde daratumumab-bindingen eller andre lokalt validerede metoder.
English: The median age was 58 (range: 22 to 65) years.
Danish: Medianalderen var 58 år (interval: 22 til 65 år).
English: In the Phase III study MMY3007, which compared treatment with D-VMP to treatment with VMP in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, safety analysis of the subgroup of patients with an ECOG performance score of 2 (D-VMP: n=89, VMP: n=84), was consistent with the overall population (see section 5.1).
Danish: I fase III-studiet MMY3007, hvor behandling med D-VMP blev sammenlignet med behandling med VMP hos patienter med nydiagnosticeret myelomatose, som ikke er kandidater til autolog stamcelletransplantation, svarede sikkerhedsanalysen af undergruppen af patienter med en ECOGperformancescore på 2 (D-VMP: n = 89, VMP: n = 84) til den samlede population (se pkt.
English: Interference with Indirect Antiglobulin Test (Indirect Coombs Test) Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching (see section 4.4).
Danish: Interferens med indirekte antiglobulintest (indirekte Coombs test) Daratumumab bindes til CD38 på erytrocytter og interfererer med forligelighedstest, herunder screening for antistoffer og krydsmatching (se pkt.
English: What DARZALEX is used for
Danish: Hvad anvendes DARZALEX til
English: Prior therapies included bortezomib (100%), lenalidomide (95%), pomalidomide (36%) and carfilzomib (19%).
Danish: Tidligere behandlinger inkluderede bortezomib (100 %), lenalidomid (95 %), pomalidomid (36 %) og carfilzomib (19 %).
English: In clinical trials (monotherapy and combination treatments; N=2066) the incidence of any grade infusion-related reactions was 37% with the first (16 mg/kg, Week 1) infusion of DARZALEX, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions.
Danish: I kliniske forsøg (monoterapi og kombinationsbehandlinger; n = 2.066) var forekomsten af infusionsrelaterede reaktioner af enhver grad 37 % ved den første (16 mg/kg, uge 1) infusion af DARZALEX, 2 % ved infusionen i uge 2 og kumulativt 6 % ved efterfølgende infusioner.
English: The clinical efficacy and safety of DARZALEX monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who had demonstrated disease progression on the last therapy, was demonstrated in two open-label studies.
Danish: Den kliniske virkning og sikkerhed ved DARZALEX-monoterapi hos voksne patienter med recidiverende og refraktær myelomatose, hvor tidligere behandling omfattede en proteasomhæmmer og et immunmodulerende stof, og som havde vist sygdomsprogression med den seneste behandling, blev påvist i to åbne studier.