FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the four population PK analyses (Analyses 1-4) body weight was identified as a statistically significant covariate for daratumumab clearance.
Danish: Baseret på de fire farmakokinetiske populationsanalyser (analyse 1-4) blev legemsvægt identificeret som en statistisk signifikant kovariat for daratumumab-clearance.
English: If you become pregnant while being treated with this medicine, tell your doctor or nurse straight away.
Danish: Hvis du bliver gravid, mens du er i behandling med dette lægemiddel, skal du fortælle det til lægen eller sundhedspersonalet med det samme.
English: (see Figure 4).
Danish: (angivet i afsnit 6).
English: Relapsed/Refractory multiple myeloma
Danish: Recidiverende/refraktær myelomatose
English: In patients with persistent very good partial response, where daratumumab interference is suspected, consider using a validated daratumumab-specific IFE assay to distinguish daratumumab from any remaining endogenous M protein in the patient's serum, to facilitate determination of a complete response.
Danish: Hos patienter med vedvarende meget godt partielt respons, og hvor der er mistanke om daratumumab-interferens, skal det overvejes at anvende en valideret, daratumumab-specifik IFE-analyse for at skelne daratumumab fra andre tilbageværende endogene M-proteiner i serum fra patienten for at lette bestemmelsen af et komplet respons.
English: This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria.
Danish: Dette kan medføre falsk positive SPE- og IFE-analyseresultater hos patienter med IgG kappamyelomprotein og påvirke den indledende vurdering af komplet respons i henhold til kriterierne fra International Myeloma Working Group (IMWG).
English: DARZALEX is given as an infusion (drip) into a vein.
Danish: DARZALEX gives som en infusion (et drop) i en vene.
English: Tell your doctor or nurse straight away if you get any of the infusion-related reactions listed at the top of section 4.
Danish: Fortæl det straks til lægen eller sundhedspersonalet, hvis du får en af de infusionsrelaterede reaktioner, der er nævnt øverst i afsnit 4.
English: All patients should be monitored throughout the infusion for IRRs.
Danish: Alle patienter skal overvåges for IRR'er under hele infusionen.
English: In the 1 to 24 mg/kg cohorts, peak serum concentrations (Cmax) after the first dose increased in approximate proportion to dose and volume of distribution was consistent with initial distribution into the plasma compartment.
Danish: I 1 til 24 mg/kg kohorterne steg de højeste serumkoncentrationer (Cmax) efter den første dosis omtrent proportionalt med dosis, og fordelingsvolumenet var i overensstemmelse med den indledende fordeling i plasmakompartmentet.
English: Table 5: Infusion rates for DARZALEX (16 mg/kg) administration
Danish: Tabel 5: Infusionshastigheder for administration af DARZALEX (16 mg/kg)
English: • medicines to lower swelling and irritation in your lungs (corticosteroids)
Danish: • lægemidler, der mindsker hævelse og irritation i dine lunger (kortikosteroider).
English: Median durations of infusions were 4.2 h for Week 1-Day 1, 4.2 h for Week 1-Day 2, and 3.4 hours for the subsequent infusions.
Danish: Den mediane varighed af infusionerne var 4,2 timer for uge 1, dag 1, 4,2 timer for uge 1, dag 2 og 3,4 timer for de efterfølgende infusioner.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and should be no more than 24 hours at refrigerated conditions (2°C-8°C) protected from light, followed by 15 hours (including infusion time) at room temperature (15°C-25°C) and room light.
Danish: Hvis præparatet ikke anvendes straks, er opbevaringstider og -forhold brugerens ansvar og må ikke være længere end 24 timer på køl (2 °C - 8 °C), beskyttet mod lys, efterfulgt af 15 timer (inklusive infusionstid) ved stuetemperatur (15 °C - 25 °C) og almindelig belysning.
English: Complete response (CR)
Danish: Komplet respons (CR)
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Maternal IgG is excreted in human milk, but does not enter the neonatal and infant circulations in substantial amounts as they are degraded in the gastrointestinal tract and not absorbed.
Danish: Maternelt IgG udskilles i human mælk, men det optages ikke i væsentlige mængder i blodbanen hos nyfødte og spædbørn, da det nedbrydes i mave-tarm-kanalen og ikke absorberes.
English: Thalidomide was administered orally at 100 mg daily during the six bortezomib cycles.
Danish: Thalidomid blev administreret oralt med en dosis på 100 mg dagligt i de seks serier med bortezomib.
English: The median duration of response was not reached (95% CI: 5.6 months, not estimable).
Danish: Den mediane responsvarighed blev ikke nået (95 % CI: 5,6 måneder; kan ikke estimeres).
English: In Study MMY3006, the number of CD34+ cell yield was numerically lower in the D-VTd arm compared with the VTd arm (Median: D-VTd: 6.3 x 10
Danish: I studie MMY3006 var udbyttet af CD34+ celler numerisk lavere i D-VTd-armen sammenlignet med VTd-armen (median: D-VTd: 6,3 x 10
English: In addition, daratumumab modulated CD38 enzymatic activity, inhibiting the cyclase enzyme activity and stimulating the hydrolase activity.
Danish: Desuden modulerede daratumumab den enzymatiske aktivitet af CD38 ved at hæmme cyklaseaktivitet og stimulere hydrolaseaktivitet.
English: Methylprednisolone 100 mg, or equivalent, administered intravenously.
Danish: 100 mg methylprednisolon eller ækvivalent hermed administreret intravenøst.
English: Newly diagnosed multiple myeloma
Danish: Nydiagnosticeret myelomatose
English: This includes medicines you can get without a prescription, and herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, og naturlægemidler.
English: Red blood cell genotyping is not impacted by daratumumab and may be performed at any time.
Danish: Genotypebestemmelse af erytrocytter påvirkes ikke af daratumumab og kan udføres når som helst.
English: • medicines to help the airways in your lungs stay open (bronchodilators)
Danish: • lægemidler, der hjælper dine luftveje med at holde sig åbne (bronkodilatorer)
English: The overall response rate was 90% in the D-VMP group and 74% in theVMP group (VGPR rate:29% in D-VMP group and 26% in VMP group; CR: 22% in D-VMP group and 18% in VMP group; sCR rate: 20% in D-VMP group and 7% in VMP group).
Danish: Den samlede responsrate var 90 % i D-VMP-gruppen og 74 % i VMP-gruppen (VGPRrate: 29 % i D-VMP-gruppen og 26 % i VMP-gruppen; CR: 22 % i D-VMP-gruppen og 18 % i VMPgruppen; sCR-rate: 20 % i D-VMP-gruppen og 7 % i VMP-gruppen).
English: If an emergency transfusion is required, non-cross-matched ABO/RhD-compatible RBCs can be given per local blood bank practices.
Danish: Hvis der bliver brug for transfusion i en nødsituation, kan der gives ikke-krydsmatchede ABO/RhD-forligelige erytrocytter i henhold til den lokale blodbanks procedurer.
English: Women who are being given DARZALEX should use effective contraception during treatment and for 3 months after treatment.
Danish: Kvinder, der får DARZALEX, skal bruge sikker prævention under behandlingen og i 3 måneder efter afsluttet behandling.
English: Simulation of daratumumab pharmacokinetics was conducted for all recommended dosing schedules in 1,309 patients with multiple myeloma.
Danish: Der blev udført simuleringer af daratumumabs farmakokinetik for alle anbefalede doseringsregimer hos 1.309 patienter med myelomatose.
English: Median Time to Response [months (range)]
Danish: Mediantid til respons [måneder (interval)]
English: Clinical pharmacokinetic assessments of daratumumab in combination with lenalidomide, pomalidomide, thalidomide, bortezomib and dexamethasone indicated no clinically-relevant drug-drug interaction between daratumumab and these small molecule medicinal products.
Danish: Kliniske farmakokinetiske vurderinger af daratumumab i kombination med lenalidomid, pomalidomid, thalidomid, bortezomib og dexamethason indikerede ikke klinisk relevante lægemiddelinteraktioner mellem daratumumab og disse småmolekylære lægemidler.
English: How the medicine is given
Danish: Sådan får du lægemidlet
English: IRRs occurring at re-initiation of DARZALEX following ASCT were consistent in terms of symptoms and severity (Grade 3/4: <1%) with those reported in previous studies at Week 2 or subsequent infusions.
Danish: De infusionsrelaterede reaktioner, der forekom ved genopstart af DARZALEX efter ASCT var konsistente med hensyn til symptomer og sværhedsgrader (grad 3/4: < 1 %) som blev rapporteret i tidligere studier ved infusioner i uge 2 eller senere.
English: CARTON (100 mg/400 mg) FOR 1 VIAL COMPONENT AS INTERMEDIATE PACK/COMPONENT OF AN INITIATION PACK (WITHOUT BLUE BOX)
Danish: ÆSKE (100 mg/400 mg) TIL 1 HÆTTEGLAS SOM MELLEMEMBALLAGE/DEL AF EN STARTPAKKE (UDEN BLÅ BOKS)
English: At baseline, 27% of patients were refractory to the last line of treatment.
Danish: Ved baseline var 27 % af patienterne refraktære over for den sidste behandlingslinje.
English: At baseline, 32% of patients were refractory to the last line of treatment.
Danish: Ved baseline var 32 % af patienterne refraktære over for den sidste behandlingslinje.
English: A subset of myeloid derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs) and B cells (CD38+Bregs) are decreased by daratumumab mediated cell lysis.
Danish: En undergruppe af myeloid-afledte suppressorceller (CD38+MDSCs), regulatoriske T-celler (CD38+Tregs) og B-celler (CD38+Bregs) mindskes på grund af daratumumab-medieret cellelyse.
English: For patients with evidence of positive HBV serology, monitor for clinical and laboratory signs of HBV reactivation during, and for at least six months following the end of DARZALEX treatment.
Danish: Patienter med positiv HBV-serologi skal monitoreres for kliniske og laboratoriemæssige tegn på reaktivering af HBV under behandlingen med DARZALEX og i mindst seks måneder efter seponering.
English: Prepare the solution for infusion using aseptic technique as follows:
Danish: Infusionsvæsken skal klargøres med aseptisk teknik på følgende måde:
English: All patients were ≤ 65 years: 43% were in the age group ≥ 60-65 years, 41% were in the age group ≥ 50-60 years and 16% below age of 50 years.
Danish: Alle patienter var ≤ 65 år: 43 % var i aldersgruppen ≥ 60-65 år, 41 % var i aldersgruppen ≥ 50-60 år, og 16 % var under 50 år.
English: DARZALEX is supplied as a carton pack containing 1 glass vial.
Danish: DARZALEX leveres i en karton, der indeholder 1 hætteglas af glas.
English: Sodium acetate trihydrate Sodium chloride Water for injections
Danish: Natriumacetattrihydrat Natriumchlorid Vand til injektionsvæsker
English: From a microbiological point of view, unless the method of opening/ dilution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra en mikrobiologisk betragtning skal præparatet anvendes med det samme, medmindre den anvendte metode til åbning/fortynding udelukker risiko for mikrobiel kontaminering.
English: Dexamethasone 20 mg was administered on Days 1, 2, 8, 9, 15, 16 in Cycles 5 and 6.
Danish: Dexamethason 20 mg blev administreret på dag 1, 2, 8, 9, 15, 16 i serie 5 og 6.
English: However, the employed assay has limitations in detecting anti-daratumumab antibodies in the presence of high concentrations of daratumumab.
Danish: Den anvendte analyse har dog begrænsninger med hensyn til påvisning af anti-daratumumabantistoffer ved tilstedeværelse af høje koncentrationer af daratumumab.
English: Consider administering low-dose oral methylprednisolone (≤ 20 mg) or equivalent the day after the DARZALEX infusion.
Danish: Overvej at administrere en lav oral dosis af methylprednisolon (≤ 20 mg) eller ækvivalent hermed dagen efter infusion af DARZALEX.
English: In the event of a planned transfusion blood transfusion centres should be notified of this interference with indirect antiglobulin tests (see section 4.5).
Danish: I tilfælde af en planlagt transfusion skal transfusionscentret oplyses om denne interferens med indirekte antiglobulintest (se pkt.
English: For patients that experience any Grade IRRs, continue monitoring post-infusion until symptoms resolve.
Danish: For patienter, der oplever en IRR uanset grad, skal overvågningen fortsættes efter infusionen, og indtil symptomerne har fortaget sig.
English: o The guide for HCPs and Blood Banks, to advice about the risk of interference for blood typing and how to minimise it; o The Patient Alert Card.
Danish: o Guiden til læger og blodbanker med råd om risikoen for interferens med blodtypebestemmelse, og hvordan denne minimeres.
English: A decision should be made whether to discontinue breast-feeding or to discontinue DARZALEX therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med DARZALEX seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: • Since DARZALEX does not contain a preservative, diluted solutions should be administered within 15 hours (including infusion time) at room temperature (15°C-25°C) and in room light.
Danish: • Da DARZALEX ikke indeholder konserveringsmiddel, skal den fremstillede infusionsvæske administreres inden for 15 timer (inklusive infusionstid), opbevaret ved stuetemperatur (15 °C - 25 °C) og almindelig belysning.
English: The majority of patients (86%) received a prior PI, 55% of patients had received a prior IMiD, including 18% of patients who had received prior lenalidomide; and 44% of patients had received both a prior PI and IMiD.
Danish: Størstedelen af patienterne (86 %) havde tidligere fået en PI, 55 % af patienterne havde tidligere fået et IMiD (18 % af patienterne havde tidligere fået lenalidomid), og 44 % af patienterne havde tidligere fået både en PI og et IMiD.
English: The European Medicines Agency has waived the obligation to submit the results of studies with DARZALEX in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med DARZALEX i alle undergrupper af den pædiatriske population ved myelomatose (se pkt.
English: Very good partial response (VGPR)
Danish: Meget godt delvist respons (VGPR)
English: Based on in vitro studies, daratumumab may utilise multiple effector functions, resulting in immune mediated tumour cell death.
Danish: På grundlag af in vitro-studier ser det ud til, at daratumumab gør brug af flere effektorfunktioner, hvilket medfører immunmedieret tumorcelledød.
English: Oral corticosteroid (20 mg methylprednisolone or equivalent dose of an intermediate-acting or long-acting corticosteroid in accordance with local standards) should be administered on each of the two days following all infusions (beginning the day after the infusion).
Danish: Der skal administreres oralt kortikosteroid (20 mg methylprednisolon eller en dosis ækvivalent hermed af et kortikosteroid med mellemlang eller lang virkningsvarighed i henhold til lokal standard) på hver af de to dage efter alle infusioner (startende dagen efter infusionen).
English: Elderly No dose adjustments are considered necessary (see section 5.2).
Danish: Ældre Dosisjustering anses ikke for at være nødvendig (se pkt.
English: DARZALEX treatment was continued until disease progression or unacceptable toxicity.
Danish: Behandlingen med DARZALEX blev fortsat indtil sygdomsprogression eller uacceptabel toksicitet.
English: The data reflects exposure to DARZALEX (16 mg/kg) in 2066 patients with multiple myeloma including 1910 patients who received DARZALEX in combination with background regimens and 156 patients who received DARZALEX as monotherapy.
Danish: Dataene afspejler eksponering for DARZALEX (16 mg/kg) hos 2.066 patienter med myelomatose, herunder 1.910 patienter, som fik DARZALEX i kombination med baggrundsbehandlinger, og 156 patienter, som fik DARZALEX som monoterapi.
English: Very good partial response (VGPR) Partial response (PR)
Danish: Meget godt partielt respons (VGPR) Partielt respons (PR)
English: Changes in hepatic function are unlikely to have any effect on the elimination of daratumumab since IgG1 molecules such as daratumumab are not metabolised through hepatic pathways.
Danish: Ændringer i leverfunktion har sandsynligvis ingen indvirkning på eliminationen af daratumumab, da IgG1-molekyler som f.eks. daratumumab ikke metaboliseres i leveren.
English: If the patient does not experience any further IRR symptoms, infusion rate escalation may be resumed at increments and intervals as clinically appropriate up to the maximum rate of 200 mL/hour (Table 5).
Danish: Hvis patienten ikke får andre IRR-symptomer, kan infusionshastigheden øges med klinisk passende trin og intervaller op til den maksimale hastighed på 200 ml/time (tabel 5).
English: Patients should be pre-medicated with antihistamines, antipyretics and corticosteroids to reduce the risk of IRRs prior to treatment with DARZALEX.
Danish: Patienterne skal præmedicineres med antihistaminer, antipyretika og kortikosteroider før behandling med DARZALEX for at reducere risikoen for IRR'er.
English: No animal studies have been performed to evaluate the potential effects of daratumumab on reproduction or development.
Danish: Der er ikke udført dyrestudier for at evaluere de potentielle virkninger af daratumumab på reproduktion eller udvikling.
English: If you get any of the infusion-related reactions above, tell your doctor or nurse straight away.
Danish: Hvis du får en af de infusionsrelaterede reaktioner, der er nævnt ovenfor, skal du straks fortælle det til lægen eller sundhedspersonalet.
English: Weeks 7 to 54
Danish: Uge 7 til 54
English: Before and after each infusion of DARZALEX, you will be given medicines which help to lower the chance of infusion-related reactions (see “Medicines given during treatment with DARZALEX” in section 3).
Danish: Før og efter hver infusion af DARZALEX vil du få lægemidler, som kan hjælpe med at mindske risikoen for reaktioner på infusionen (se ”Lægemidler, der gives under behandling med DARZALEX” i afsnit 3).
English: There are no human or animal data to assess the risk of daratumumab use during pregnancy.
Danish: Der foreligger ingen data fra mennesker eller dyr til risikovurdering af behandling med daratumumab under graviditet.
English: Daratumumab concentration-time profiles were similar following the monotherapy and combination therapies.
Danish: Koncentration/tid-profilerne for daratumumab var de samme efter monoterapi og kombinationsterapier.
English: Due to the high affinity to a unique epitope on CD38, daratumumab is not anticipated to alter drug-metabolising enzymes.
Danish: På grund af den høje affinitet til en unik epitop på CD38 forventes daratumumab ikke at ændre lægemiddelmetaboliserende enzymer.
English: DARZALEX is a concentrate for solution for infusion and is a colourless to yellow liquid.
Danish: DARZALEX er et koncentrat til infusionsvæske, opløsning og er en farveløs til gul væske.
English: These studies suggest that daratumumab can induce tumour cell lysis through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis in malignancies expressing CD38.
Danish: Disse studier antyder, at daratumumab kan inducere tumorcellelyse gennem komplement-afhængig cytotoksicitet, antistof-afhængig cellemedieret cytotoksicitet og antistof-afhængig cellulær fagocytose ved sygdomme, hvor CD38 udtrykkes.
English: See below “Recommended concomitant medications”, “Management of infusion-related reactions” and section 4.4.
Danish: Se ”Anbefalinger om samtidig administration af lægemidler” og ”Håndtering af infusionsrelaterede reaktioner” nedenfor samt pkt.
English: The mean (standard deviation [SD]) estimated terminal half-life of daratumumab following the first 16 mg/kg dose was 9 (4.3) days.
Danish: Den gennemsnitlige (standardafvigelse [SD]) estimerede terminale halveringstid for daratumumab efter den første dosis på 16 mg/kg var 9 (4,3) dage.
English: Week 55 onwards until disease progression b every four weeks
Danish: Uge 55 og frem, indtil sygdomsprogression hver fjerde uge
English: Patients had IgG/IgA/Light chain myeloma in 64%/22%/10% of instances, 19% had ISS Stage I, 42% had ISS Stage II, 38% had ISS Stage III disease and 84% had standard risk cytogenetics.
Danish: Patienterne havde IgG-/IgA/L-kædemyelom i 64 %/22 %/10 % af tilfældene, 19 % havde ISS stadie I, 42 % havde ISS stadie II, 38 % havde ISS stadie III og 84 % havde cytogenetik med standardrisiko.
English: You must not be given DARZALEX - if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få DARZALEX - hvis du er allergisk over for daratumumab eller et af de øvrige indholdsstoffer i DARZALEX
English: It is administered as an intravenous infusion following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Det administreres som en intravenøs infusion efter fortynding med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske.
English: This medicine contains 9.3 mg sodium (main component of cooking/table salt) in each 5 mL vial.
Danish: Dette lægemiddel indeholder 9,3 mg natrium (hovedkomponenten i madlavnings-/bordsalt) i hvert hætteglas med 5 ml.
English: DARZALEX will be stored at the hospital or clinic.
Danish: DARZALEX opbevares på hospitalet.
English: Linear mixed PK-PD analyses indicated no large increase in mean QTcF interval (i.e. greater than 20 ms) at daratumumab Cmax.
Danish: Lineær blandet farmakokinetisk/farmakodynamisk analyse indikerede ingen større stigning i gennemsnitligt QTcF-interval (dvs. større end 20 ms) ved Cmax for daratumumab.
English: • Gently invert the bag/container to mix the solution.
Danish: • Vend forsigtigt posen/beholderen på hovedet for at blande opløsningen.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E)
English: DARZALEX delay may be required to allow recovery of blood cell counts.
Danish: Det kan være nødvendigt at udskyde DARZALEX for at give mulighed for gendannelse af blodlegemer.
English: • Grade 3 (severe): Once reaction symptoms resolve, restarting of the infusion may be considered at no more than half the rate at which the reaction occurred.
Danish: • Grad 3 (svær): Når symptomerne på reaktionen er forsvundet, kan det overvejes at genstarte infusionen ved en hastighed, der ikke må overstige halvdelen af den hastighed, ved hvilken
English: An odds ratio > 1 indicates an advantage for DVd.
Danish: En oddsratio > 1 indikerer en fordel for DVd.
English: If the patient does not experience additional symptoms, infusion rate escalation may be resumed at increments and intervals as appropriate (Table 5).
Danish: Hvis patienten ikke får flere symptomer, kan infusionshastigheden øges med passende trin og intervaller (tabel 5).
English: This is equivalent to 1.86% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 1,86 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: Warnings and precautions Talk to your doctor or nurse before you are given DARZALEX:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sygeplejersken, før du får DARZALEX.
English: Dilution volume
Danish: Fortyndet volumen
English: Melphalan at 9 mg/m2, and prednisone at 60 mg/m2 were orally administered on Days 1 to 4 of the nine 6-week cycles (Cycles 1-9).
Danish: 9 mg/m melphalan og 60 mg/m2 prednison blev administreret oralt på dag 1 til 4 i de ni 6-ugers serier (serie 1-9).
English: Week 1 Day 2 (8 mg/kg)
Danish: Uge 1, dag 2 (8 mg/kg)