FrancophonIA/ELRC3.0 huggingface dataset:
English: Nervous system disorders Peripheral sensory neuropathy
Danish: Perifer sensorisk neuropati
English: DARZALEX may be given alone or together with other medicines used to treat multiple myeloma.
Danish: DARZALEX kan gives enten alene eller sammen med andre lægemidler, som anvendes til at behandle myelomatose.
English: CD38 protein has multiple functions such as receptor mediated adhesion, signalling and enzymatic activity.
Danish: CD38-proteinet har flere funktioner som f.eks. receptormedieret adhæsion, signalering og enzymatisk aktivitet.
English: Therefore, body weight based dosing is an appropriate dosing strategy for the multiple myeloma patients.
Danish: Derfor er dosering baseret på legemsvægt en passende strategi for dosering til patienter med myelomatose.
English: Seventy-four percent of patients had received prior ASCT.
Danish: 74 % af patienterne havde tidligere fået ASCT.
English: DARZALEX has no or negligible influence on the ability to drive and use machines.
Danish: DARZALEX påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: • feeling short of breath or other breathing problems.
Danish: • kortåndethed eller andre vejrtrækningsproblemer.
English: It is given as a drip into a vein (“intravenous infusion”) over several hours.
Danish: Medicinen indgives som et drop i en vene (intravenøs infusion) over flere timer.
English: MRD negativity rate a,c n(%)
Danish: MRD-negativitetsrate a,c n(%)
English: However, baseline levels of NK cells did not show an association with clinical response.
Danish: Niveauet af NK-celler ved baseline viste dog ingen forbindelse med klinisk respons.
English: When given alone, DARZALEX is given as follows:
Danish: Når DARZALEX gives alene, gives det på følgende måde:
English: People with breathing problems
Danish: Patienter med vejrtrækningsproblemer
English: Your doctor may decide not to use DARZALEX if you have a strong infusion reaction.
Danish: Din læge kan beslutte, at du ikke skal have DARZALEX, hvis du reagerer kraftigt på infusionen.
English: Prophylaxis for herpes zoster virus reactivation Anti-viral prophylaxis should be considered for the prevention of herpes zoster virus reactivation.
Danish: Profylakse mod reaktivering af herpes zoster-virus Antiviral profylakse skal overvejes for at forebygge reaktivering af herpes zoster-virus.
English: It is not known whether daratumumab is excreted into human or animal milk.
Danish: Amning Det vides ikke, om daratumumab udskilles i human eller animalsk mælk.
English: The significance of these in vitro effects in a clinical setting, and the implications on tumour growth, are not well-understood.
Danish: Den kliniske betydning af disse in vitro virkninger og implikationerne for tumorvækst er ikke klarlagt til fulde.
English: Uncommon (may affect up to 1 in 100 people) • inflamed liver (hepatitis)
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter): • leverbetændelse (hepatitis)
English: DARZALEX should be administered by a healthcare professional, in an environment where resuscitation facilities are available.
Danish: DARZALEX skal administreres af sundhedspersonale på et sted, hvor der er adgang til genoplivningsudstyr.
English: If a planned dose of DARZALEX is missed, the dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly, maintaining the treatment interval.
Danish: Hvis en planlagt dosis af DARZALEX glemmes, skal den administreres snarest muligt, og doseringsskemaet skal justeres i henhold til dette, så behandlingsintervallet opretholdes.
English: Following the second infusion, the dose of corticosteroid may be reduced (oral or intravenous methylprednisolone 60 mg).
Danish: Efter den anden infusion kan dosis af kortikosteroid reduceres (60 mg methylprednisolon oralt eller intravenøst).
English: every two weeks (total of 4 doses) Stop for high dose chemotherapy and ASCT
Danish: hver anden uge (i alt 4 doser) Stop for højdosiskemoterapi og ASCT
English: No chronic toxicity testing has been conducted.
Danish: Der er ikke udført test for kronisk toksicitet.
English: Primary efficacy endpoint (International Myeloma Working Group criteria) CI=confidence interval; NE=not estimable; MR=minimal response
Danish: Primært effektmål (kriterier fra International Myeloma Working Group) CI = konfidensinterval; NE = kan ikke estimeres; MR = minimalt respons
English: Monitor patients with neutropenia for signs of infection.
Danish: Patienter med neutropeni skal overvåges for tegn på infektion.
English: Combination treatment with lenalidomide:
Danish: Kombinationsbehandling med lenalidomid:
English: this is the terminal half-life that can be expected upon complete saturation of target mediated clearance and repeat dosing of daratumumab.
Danish: Dette er den terminale halveringstid, der kan forventes efter komplet mætning af målmedieret clearance og gentagen dosering af daratumumab.
English: The effect of daratumumab on newborns/infants is unknown.
Danish: Virkningen af daratumumab på nyfødte/spædbørn kendes ikke.
English: For patients with Grade 1, 2, or 3 IRRs, the infusion rate should be reduced when re-starting the infusion.
Danish: For patienter med IRR'er af grad 1, 2 eller 3 skal infusionshastigheden reduceres, når infusionen startes igen.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC24
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC24
English: If you forget your appointment to have DARZALEX It is very important to go to all your appointments to make sure your treatment works.
Danish: Hvis du glemmer en aftale, hvor du skal have DARZALEX Det er meget vigtigt, at du kommer til alle dine aftaler for at sikre, at behandlingen virker.
English: The mean (SD) central volume of distribution is 56.98 (18.07) mL/kg.
Danish: Det gennemsnitlige (SD) centrale fordelingsvolumen er 56,98 (18,07) ml/kg.
English: Hepatitis B virus (HBV) Reactivation
Danish: Reaktivering af hepatitis B-virus (HBV)
English: Daratumumab has been designed to attach to specific cancer cells in your body, so that your immune system can destroy the cancer cells.
Danish: Daratumumab er designet til at koble sig fast på bestemte kræftceller i din krop, så dit immunsystem kan ødelægge kræftcellerne.
English: Less than 1% of patients had a Grade 3/4 infusion-related reaction with the Week 2 or subsequent infusions.
Danish: Under 1 % af patienterne fik en grad 3/4 infusionsrelateret reaktion ved infusionen i uge 2 eller efterfølgende infusioner.
English: If you have breathing problems, such as asthma or Chronic Obstructive Pulmonary Disease (COPD), you will be given medicines to inhale which help your breathing problems:
Danish: Hvis du har vejrtrækningsproblemer som f.eks. astma eller KOL (kronisk obstruktiv lungesygdom), vil du få lægemidler til inhalation, som kan afhjælpe dine vejrtrækningsproblemer:
English: The usual starting dose of DARZALEX is 16 mg per kg of body weight.
Danish: Den sædvanlige startdosis af DARZALEX er 16 mg pr. kg legemsvægt.
English: Study MMY3006 is a 2 Part, open-label, randomized, active-controlled Phase 3 study.
Danish: Studie MMY3006, et åbent, randomiseret, aktivt kontrolleret fase 3-studie i 2 dele.
English: T cells (CD3+, CD4+, and CD8+) are also known to express CD38 depending on the stage of development and the level of activation.
Danish: T-celler (CD3+, CD4+ og CD8+) vides også at udtrykke CD38 afhængigt af udviklingsstadie og aktiveringsniveau.
English: DARZALEX is a cancer medicine that contains the active substance daratumumab.
Danish: DARZALEX er et lægemiddel mod kræft, som indeholder det aktive stof daratumumab.
English: Oedema peripheral Pyrexia
Danish: Perifert ødem Pyrexi
English: DARZALEX can decrease white blood cell counts which help fight infections, and blood cells called platelets which help to clot blood.
Danish: DARZALEX kan nedsætte antallet af hvide blodlegemer, som hjælper med at bekæmpe infektioner, og blodplader, som hjælper blodet med at størkne.
English: In the active controlled studies, discontinuations from treatment due to infections (1-4%) and fatal infections were generally infrequent and balanced between the DARZALEX containing regimens and active control arms.
Danish: I de aktivt kontrollerede studier var seponering af behandlingen som følge af infektioner (1-4 %) og infektion med dødelig udgang generelt sjældent forekommende og ligeligt fordelt blandt regimerne med DARZALEX og de aktive kontrolarme.
English: Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies.
Danish: Komplette blodtal skal monitoreres regelmæssigt under behandlingen i henhold til producenternes ordinationsoplysninger for baggrundsterapierne.
English: DARZALEX is indicated:
Danish: DARZALEX er indiceret:
English: In clinical trials IRRs were reported in approximately half of all patients treated with DARZALEX.
Danish: I kliniske forsøg er der indberettet IRR'er for omtrent halvdelen af alle patienter behandlet med DARZALEX.
English: If you get infusion-related reactions, you may need other medicines, or the infusion may need to be slowed down or stopped.
Danish: Hvis du får infusionsrelaterede reaktioner, kan du have brug for andre lægemidler, eller det kan være nødvendigt at give infusionen langsommere eller stoppe den.
English: Following the last weekly infusion, Cmax increased in a greater than dose-proportional manner, consistent with target mediated drug disposition.
Danish: Efter den sidste ugentlige infusion steg Cmax på en måde, der var mere end proportionalt med dosis, hvilket er i overensstemmelse med mål-medieret lægemiddelfordeling.
English: DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”.
Danish: DARZALEX anvendes til voksne på 18 år og derover, som har en type kræft, der hedder myelomatose.
English: Efficacy was evaluated by progression free survival (PFS) based on International Myeloma Working Group (IMWG) criteria.
Danish: Effekt blev vurderet som progressionsfri overlevelse (PFS) baseret på kriterier fra IMWG (International Myeloma Working Group).
English: A dilution volume of 500 mL for the 16 mg/kg dose should be used only if there were no IRRs the previous week.
Danish: Der bør kun anvendes et fortyndingsvolumen på 500 ml for 16 mg/kg dosen ved fravær af IRR'er i den foregående uge.
English: The mean estimated terminal half-life associated with linear clearance in combination therapy was approximately 15-23 days.
Danish: Den estimerede gennemsnitlige terminale halveringstid i forbindelse med kombinationsterapi (lineær clearance) var cirka 15-23 dage.
English: DARZALEX will be given to you by a doctor or nurse.
Danish: Du vil få DARZALEX af en læge eller sygeplejerske.
English: You and your doctor will decide if the benefit of having the medicine is greater than the risk to your baby.
Danish: Du og din læge vil beslutte, om fordelen for dig ved at få lægemidlet er større end risikoen for barnet.
English: 6/kg) and among those who completed mobilization, more patients in the D-VTd group received plerixafor compared to those in the VTd arm (D-VTd: 21.7%; VTd: 7.9%).
Danish: 6/kg), og blandt dem, som fuldførte mobilisering, fik flere patienter i D-VTd-gruppen plerixafor sammenlignet med dem i VTd-armen (D-VTd: 21,7 %; VTd: 7,9 %).
English: Tell your doctor right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes.
Danish: Kontakt omgående lægen, hvis du oplever tiltagende træthed eller gulfarvning af huden eller det hvide i øjnene.
English: Patients refractory to lenalidomide were excluded from the study.
Danish: Patienter, som var refraktære over for lenalidomid, blev ekskluderet fra studiet.
English: • Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 or 0.2 micrometre).
Danish: • Administrer infusionsvæsken via intravenøs infusion med et infusionssæt, hvor der er påsat en flow-regulator og et indlejret sterilt, ikke-pyrogent polyethersulfon-filter (PES) med lav proteinbinding (porestørrelse 0,22 eller 0,2 mikrometer).
English: This is a cancer of your bone marrow.
Danish: Det er kræft i knoglemarven.
English: Post-infusion medications should be administered to reduce the risk of delayed infusion-related reactions as follows:
Danish: Der skal administreres lægemidler efter infusion for at reducere risikoen for forsinkede infusionsrelaterede reaktioner på følgende måde:
English: In patients receiving DARZALEX combination therapy, Grade 3 or 4 infections were reported as follows:
Danish: Hos patienter, som fik DARZALEX som kombinationsterapi, blev der rapporteret infektioner af grad 3 eller 4 som følger:
English: Pre-planned interim analysis showed that treatment with daratumumab at 16 mg/kg led to a 36% ORR with 5% CR and 5% VGPR.
Danish: En på forhånd planlagt interimanalyse viste, at behandling med daratumumab ved en dosis på 16 mg/kg førte til en ORR på 36 % med CR på 5 % og VGPR på 5 %.
English: The determination of a patient's ABO and Rh blood type are not impacted.
Danish: o Bestemmelse af patientens ABO- og Rh-blodtype påvirkes ikke.
English: Patients in the study had received a median of 4 prior lines of therapy.
Danish: Patienterne i studiet havde i gennemsnit fået 4 tidligere behandlingslinjer.
English: • low number of white blood cells which help fight infections (neutropenia, lymphopenia,
Danish: • lavt antal hvide blodlegemer, som er med til at bekæmpe infektioner (neutropeni, lymfopeni,
English: Carcinogenicity and mutagenicity No animal studies have been performed to establish the carcinogenic potential of daratumumab.
Danish: Karcinogenicitet og mutagenicitet Der er ikke udført dyrestudier for at fastlægge den potentielle karcinogenicitet af daratumumab.
English: Alternatively, phenotyping or genotyping may also be considered (see section 4.4).
Danish: Som alternativ kan fæno- eller genotypebestemmelse også overvejes (se pkt.
English: Women of child-bearing potential/Contraception
Danish: Kvinder i den fertile alder/antikonception
English: • Check that the DARZALEX solution is colourless to yellow.
Danish: • Kontroller, at DARZALEX-koncentratet er farveløst til gult.
English: In Part 2, subjects with at least a partial response (PR) by Day 100 post-transplant were re-randomized in a 1:1 ratio to daratumumab maintenance or observation only.
Danish: I del 2 blev forsøgspersoner med mindst et delvist respons (PR) på dag 100 efter transplantationen re-randomiseret 1:1 til daratumumab vedligeholdelse eller kun observation.
English: IgG1 monoclonal antibodies are known to cross the placenta after the first trimester of pregnancy.
Danish: Monoklonale IgG1-antistoffer vides at passere placenta efter første trimester.
English: An odds ratio > 1 indicates an advantage for D-VMP. p-value from Fisher's exact test.
Danish: En oddsratio > 1 indikerer en fordel for D-VMP. p-værdi fra Fishers eksakte test.
English: Permanently discontinue DARZALEX upon the third occurrence of a Grade 3 or greater infusion reaction.
Danish: DARZALEX skal seponeres permanent ved den tredje forekomst af en infusionsreaktion af grad 3 eller højere.
English: When DARZALEX is given together with other medicines your doctor may change the time between doses as well as how many treatments you will receive.
Danish: Når DARZALEX gives sammen med andre lægemidler, kan din læge ændre perioderne mellem doser og antallet af behandlinger.
English: A modified initial rate (100 mL/hour) for subsequent infusions (i.e. Week 3 onwards) should only be used only if there were no IRRs during the previous infusion.
Danish: Der bør kun anvendes en modificeret initialhastighed (100 ml/time) ved efterfølgende infusioner (dvs. uge 3 og derefter) ved fravær af IRR'er ved de foregående infusioner.
English: Consider consulting a hepatitis disease expert as clinically indicated.
Danish: Det skal overvejes at konsultere en hepatitisekspert, hvis dette er klinisk relevant.
English: Gender did not affect exposure of daratumumab to a clinically relevant degree in the population PK analyses.
Danish: Køn påvirkede ikke eksponeringen for daratumumab i klinisk relevant grad i de farmakokinetiske populationsanalyser.
English: Patients had received a median of 5 prior lines of therapy.
Danish: Patienterne havde i gennemsnit fået 5 tidligere behandlingslinjer.
English: Tell your doctor or nurse straight away if you get any of the following signs of an infusion-related reaction during or in the 3 days after the infusion.
Danish: Fortæl det straks til lægen eller sundhedspersonalet, hvis du får et af følgende tegn på en infusionsrelateret reaktion under infusionen eller i løbet af de 3 efterfølgende dage.
English: Decreases in absolute counts and percentages of total NK cells (CD16+CD56+) and activated (CD16+CD56
Danish: Der blev observeret fald i absolutte tal og procentdele af det samlede antal NK-celler (CD16+CD56+) og aktiverede NK-celler (CD16+CD56
English: • Antihistamine (oral or intravenous diphenhydramine 25 to 50 mg or equivalent).
Danish: • Antihistamin (diphenhydramin 25 til 50 mg oralt eller intravenøst eller ækvivalent hermed).
English: Infusion bags/containers must be made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE).
Danish: Infusionsposer/-beholdere skal være fremstillet af polyvinylchlorid (PVC), polypropylen (PP), polyethylen (PE) eller en polyolefinblanding (PP+PE).
English: Prior to the launch of DARZALEX (daratumumab) in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, aiming at increasing awareness about the Important Identified Risk of “Interference for blood typing (minor antigen) (Positive Indirect Coombs' test)” and providing guidance on how to manage it.
Danish: Forud for lanceringen af DARZALEX (daratumumab) i de enkelte medlemslande skal indehaveren af markedsføringstilladelsen og den nationale sundhedsmyndighed blive enige om indholdet og formatet af uddannelsesmaterialet, der har til formål at øge opmærksomheden omkring den vigtige identificerede risiko for “Interferens i forbindelse med blodtypebestemmelse (minor antigener) (positiv indirekte Coombs test)” og give vejledning i håndteringen af denne risiko.
English: These observations suggest CD38 may become saturated at higher doses, after which the impact of target binding clearance is minimised and the clearance of daratumumab approximates the linear clearance of endogenous IgG1.
Danish: Disse observationer tyder på, at CD38 kan blive mættet ved højere doser, hvorefter virkningen af målbindende clearance minimeres, og clearance af daratumumab nærmer sig den lineære clearance af endogent IgG1.
English: Glacial acetic acid Mannitol (E421) Polysorbate 20
Danish: Koncentreret eddikesyre Mannitol (E421) Polysorbat 20
English: Recommended concomitant medications
Danish: Lægemidler, der anbefales til samtidig indgivelse
English: Furthermore, safety analysis of the subgroup of patients with an ECOG performance score of 2 (D-VMP: n=89, VMP: n=84), was also consistent with the overall population.
Danish: Desuden svarede sikkerhedsanalysen af undergruppen af patienter med en ECOG-performancescore på 2 (D-VMP: n = 89, VMP: n = 84) også til den samlede population.
English: In addition, T-cell receptor DNA sequencing verified that T-cell clonality was increased with daratumumab treatment, indicating immune modulatory effects that may contribute to clinical response.
Danish: Desuden bekræftede DNA-sekventering af T-cellereceptorer, at T-cellernes klonalitet blev øget ved behandling med daratumumab, hvilket tyder på immunmodulerende virkninger, som kan bidrage til det kliniske respons.
English: A subgroup analysis was performed on patients at least 70 years old, or those 65-69 years old with ECOG performance score of 2, or aged less than 65 years of age with significant comorbidity or ECOG performance score of 2 (D-VMP: n=273, VMP: n=270).
Danish: Der blev udført en undergruppeanalyse med patienter, som var mindst 70 år, eller som var 65-69 år og havde en ECOG-performancescore på 2, eller som var under 65 år og havde signifikant komorbiditet eller en ECOG-performancescore på 2 (D-VMP: n = 273, VMP: n = 270).
English: Dexamethasone is given intravenously prior to the first DARZALEX infusion and oral administration may be considered prior to subsequent infusions.
Danish: Dexamethason indgives intravenøst før den første infusion af DARZALEX, og oral administration kan overvejes før efterfølgende infusioner.
English: The simulation results confirmed that the split and single dosing for the first dose provide similar PK, with the exception of the PK profile in the first day of the treatment.
Danish: Resultaterne af disse simuleringer bekræftede, at opdelt og enkelt dosering af første dosis giver samme farmakokinetik, med undtagelse af den farmakokinetiske profil på første dag af behandlingen.
English: As such, variations in drug-metabolising enzymes are not expected to affect the elimination of daratumumab.
Danish: Som sådan forventes variationer i lægemiddelmetaboliserende enzymer ikke at påvirke eliminationen af daratumumab.
English: You may need other medicines, or the infusion may need to be slowed down or stopped.
Danish: Du kan have brug for andre lægemidler, eller infusionshastigheden skal muligvis nedsættes eller infusionen stoppes.
English: Patients refractory to bortezomib were excluded from the study.
Danish: Patienter, som var refraktære over for bortezomib, blev ekskluderet fra studiet.
English: If you are not sure, talk to your doctor or nurse before you are given DARZALEX.
Danish: Hvis du ikke er sikker, så tal med lægen eller sundhedspersonalet, før du får DARZALEX.
English: • Grade 4 (life-threatening): Permanently discontinue DARZALEX treatment.
Danish: • Grad 4 (livstruende): DARZALEX seponeres permanent.
English: Daratumumab as a large protein has a low likelihood of direct ion channel interactions.
Danish: Daratumumab har som et stort protein lav sandsynlighed for direkte ionkanalinteraktioner.
English: • infections of the airways - such as nose, sinuses or throat
Danish: • luftvejsinfektioner, f.eks. i næse, bihuler eller hals
English: • low number of red blood cells which carry oxygen in the blood (anaemia)
Danish: • lavt antal røde blodlegemer, som transporterer ilt rundt i blodet (anæmi)
English: The diluted solution may develop very small, translucent to white proteinaceous particles, as daratumumab is a protein.
Danish: Der kan dannes meget små, gennemsigtige til hvide proteinagtige partikler i den fortyndede opløsning, da daratumumab er et protein.
English: Daratumumab induced apoptosis in vitro after Fc mediated cross-linking.
Danish: Daratumumab inducerede apoptose in vitro efter Fc-medieret krydsbinding.
English: The majority of IRRs occurred at the first infusion and were Grade 1-2 (see section 4.8).
Danish: Størstedelen af IRR'erne forekom ved den første infusion og var af grad 1-2 (se pkt.
English: Infusion rate/dilution volume used upon re-initiation was that used for the last DARZALEX infusion prior to interruption due to ASCT.
Danish: Infusionshastigheden/fortyndingsvolumen anvendt ved genopstart, var den samme, som blev anvendt ved den sidste infusion af DARZALEX inden afbrydelse på grund af ASCT.
English: CARTON (100 mg/400 mg) (WITH BLUE BOX)
Danish: ÆSKE (100 mg/400 mg) (MED BLÅ BOKS)
English: Neutropenia/Thrombocytopenia
Danish: Neutropeni/trombocytopeni
English: Based on population PK analysis, the mean (SD) half-life associated with non-specific linear elimination was approximately 18 (9) days;
Danish: Ud fra den farmakokinetiske populationsanalyse var den gennemsnitlige (SD) halveringstid, forbundet med ikke-specifik lineær elimination, cirka 18 (9) dage.
English: • medicines for inflammation (corticosteroids)
Danish: • lægemidler mod inflammation (kortikosteroider)
English: Polyurethane (PU), polybutadiene (PBD), PVC, PP or PE administration sets must be used.
Danish: Der skal anvendes et administrationssæt af polyurethan (PU), polybutadien (PBD), PVC, PP eller PE.