FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaphylactic reaction Uncommon
Danish: Anafylaktisk reaktion Ikke almindelig
English: Table 1: Reconstitution instructions
Danish: Tabel 1: Vejledning i rekonstitution
English: The rate of infusion reactions was much higher in patients who were not premedicated.
Danish: Infusionsreaktioner var meget hyppigere hos patienter, der ikke var præmedicinerede.
English: If there is no recurrence of the infusion reaction, the escalation can be resumed (see Tables 3 and 4).
Danish: Hvis infusionsreaktionen ikke opstår igen, kan optrapning af infusionshastigheden fortsætte (se tabel 3 og 4).
English: Empliciti contains sodium
Danish: Empliciti indeholder natrium
English: Empliciti may be detected in the serum protein electrophoresis (SPEP) and serum immunofixation assays of myeloma patients and could interfere with correct response classification.
Danish: Empliciti kan detekteres i serumprotein elektroforese (SPEP)-analyser og serum immunfikseringsanalyser hos patienter med myelom og kan muligvis påvirke korrekt responsklassificering.
English: The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in treatment of 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 i alle undergrupper af den pædiatriske population ved behandling af myelomatose (se pkt.
English: If not used immediately, the solution for infusion may be stored in the refrigerator (2 °C - 8 °C) for up to 24 hours.
Danish: Hvis Empliciti ikke anvendes straks, kan infusionsvæsken opbevares i køleskab (2 °C - 8 °C) i op til 24 timer.
English: Thus, the effect of elotuzumab on male and female fertility is unknown.
Danish: Derfor er elotuzumabs indvirkning på hunlig og hanlig fertilitet ukendt.
English: Patients in the E-Ld arm had an 18% reduction in the risk of death compared with those in the Ld arm (HR = 0.82; 95.4% CI: 0.68, 1.00; p-value = 0.0408).
Danish: Patienterne i E-Ld-armen havde en reduktion på 18% i risikoen for dødsfald sammenlignet med patienterne i Ld-armen (HR = 0,82; 95,4% CI: 0,68, 1,00; p-værdi = 0,0408).
English: Medicines given before each infusion You must receive the following medicines before each infusion of Empliciti to help reduce possible infusion reactions: medicine to reduce an allergic reaction (an anti-histamine) medicine to reduce inflammation (dexamethasone) medicine to reduce pain and fever (paracetamol)
Danish: Medicin, du får før hver infusion Du skal have følgende medicin før hver infusion af Empliciti for at forebygge eventuelle infusionsreaktioner: medicin til forebyggelse af en allergisk reaktion (et antihistamin) medicin mod betændelseslignende tilstande (dexamethason) medicin mod smerter og feber (paracetamol)
English: In cycles 3 and beyond, once every 4 weeks on day 1.
Danish: I cyklus 3 og derefter, en gang hver fjerde uge på dag 1.
English: The median number of prior therapies was 2.
Danish: Det mediane antal tidligere behandlinger var 2.
English: The median number of treatment cycles was 9 for the E-Pd arm and 5 for the Pd arm.
Danish: Det mediane antal behandlingscyklusser var 9 i E-Pd-armen og 5 i Pd-armen.
English: Withdraw the necessary volume for the calculated dose from each vial, up to a maximum of 16 mL from 400 mg vial and 12 mL from 300 mg vial.
Danish: Udtag det nødvendige volumen til den beregnede dosis fra hvert hætteglas, op til højst 16 ml fra 400 mg hætteglasset og 12 ml fra 300 mg hætteglasset.
English: Empliciti is used to treat multiple myeloma (a cancer of the bone marrow) in adults.
Danish: Empliciti anvendes til behandling af myelomatose (kræft i knoglemarven) hos voksne.
English: Median PFS (months) [95% CI]
Danish: Median PFS (måneder) [95% CI]
English: The International Staging System (ISS) Stage was I in 50%, II in 38% and III in 12% of patients.
Danish: ISS-stadiet (The International Staging System) var I hos 50%, II hos 38% og III hos 12% af patienterne.
English: Herpes zosterd 51 10.0 Oropharyngeal pain
Danish: Herpes zosterd 51 10,0 Orofaryngeale smerter
English: 20 ml Type I glass vial, closed with a grey butyl stopper and sealed with aluminium crimp seal with a polypropylene flip off button, containing either 300 mg or 400 mg elotuzumab.
Danish: 20 ml hætteglas (type I-glas), lukket med en grå butylprop og forseglet med en aluminiumkrave med et flip-off-låg af polypropylen, med enten 300 mg eller 400 mg elotuzumab.
English: The median number of prior therapies was 3.
Danish: Det mediane antal tidligere behandlinger var 3.
English: No clinically important differences in the clearance of Empliciti were found between patients with mild hepatic impairment and patients with normal hepatic function.
Danish: Der blev ikke fundet klinisk signifikante forskelle i Empliciti-clearance mellem patienter med let nedsat leverfunktion og patienter med normal leverfunktion.
English: What Empliciti contains
Danish: Empliciti indeholder
English: SLAMF7 is also expressed on natural killer cells (NK), normal plasma cells, and other immune cells including some T cell subsets, monocytes, B cells, macrophages, and pDCs (plasmacytoid dendritic cells), but is not detected on normal solid tissues or haematopoietic stem cells.
Danish: SLAMF7 er også udtrykt på naturlige dræberceller (NK-celler), normale plasmaceller og andre immunceller, inklusive nogle undergrupper af T-celler, monocytter, B-celler, makrofager og pDC'er (plasmacytoide dendritceller), men er ikke set på normale solide væv eller hæmatopoietiske stamceller.
English: Transfer the withdrawn volumes of all vials needed according to the calculated dose for this patient into one single infusion bag made of polyvinyl chloride or polyolefin containing the calculated volume of diluent.
Danish: Overfør de udtagne voluminer fra alle hætteglas der er nødvendige ifølge den beregnede dosis for denne patient, til en enkelt infusionspose lavet af polyvinylchlorid eller polyolefin, der indeholder den beregnede volumen fortyndingsvæske.
English: H2 blocker: ranitidine (50 mg intravenous or 150 mg orally) or equivalent H2 blocker.
Danish: H2-blokker: ranitidin (50 mg intravenøst eller 150 mg oralt) eller anden H2-blokker ækvivalent hermed.
English: The 1-, 2-, 3-, 4- and 5-year rates of overall survival for Empliciti in combination with lenalidomide and dexamethasone treatment were 91%, 73%, 60%, 50% and 40% respectively, compared with 83%, 69%, 53%, 43% and 33% respectively, for lenalidomide and dexamethasone treatment (See Figure 2).
Danish: Samlet overlevelse ved år 1, 2, 3, 4 og 5 for Empliciti kombineret med lenalidomid og dexamethason var henholdsvis 91%, 73%, 60%, 50% og 40% sammenlignet med henholdsvis 83%, 69%, 53%, 43% og 33% ved lenalidomid og dexamethason (se figur 2).
English: Common (may affect up to 1 in 10 people) Chest pain
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer) Brystsmerter
English: For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsbetingelser efter rekonstitution eller fortynding af lægemidlet, se pkt.
English: On the basis of reported adverse reactions, Empliciti is not expected to influence the ability to drive or use machines.
Danish: På baggrund af de rapporterede bivirkninger forventes Empliciti ikke at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: PFS ITT assessment per investigator was evaluated in several subgroups including age (< 65 versus ≥ 65), race, ISS stage, prior therapies, transplant, risk category, ECOG status, creatinine clearance, and cytogenic abnormalities.
Danish: PFS ITT-vurdering ifølge investigator blev evalueret i adskillige undergrupper inklusive alder (< 65 versus ≥ 65), race, ISS-stadie, tidligere behandlinger, transplantation, risikokategori, ECOG-status, kreatinin-clearance og cytogenetiske abnormiteter.
English: Premedication consisting of dexamethasone, H1 blocker, H2 blocker, and paracetamol must be administered prior to Empliciti infusion (see section 4.2 Premedication).
Danish: Præmedicinering bestående af dexamethason, H1-blokker, H2-blokker og paracetamol skal administreres forud for infusion af Empliciti (se pkt.
English: Final volume of reconstituted Empliciti in the vial (including volume displaced by the solid cake)
Danish: Endeligt volumen af rekonstitueret Empliciti i hætteglasset (inklusive den faste bloks volumen)
English: The metabolic pathway of elotuzumab has not been characterized.
Danish: Elotuzumabs metaboliseringsvej er ikke klarlagt.
English: However, if oral or intravenous dexamethasone is delayed or discontinued, the administration of Empliciti should be based on clinical judgment (e.g. risk of hypersensitivity) (see section 4.4).
Danish: Hvis oralt eller intravenøst administreret dexamethason udskydes, eller dexamethason seponeres, skal administration af Empliciti baseres på en klinisk vurdering (f.eks. risiko for overfølsomhed) (se pkt.
English: Tell your doctor or nurse straight away if you get any of the infusion reactions listed at the top of section 4.
Danish: Fortæl det straks til lægen eller sundhedspersonalet, hvis du får en eller flere af de infusionsreaktioner, der er beskrevet i starten af afsnit 4.
English: The International Staging System (ISS) Stage was I in 43%, II in 32% and III in 21% of patients.
Danish: ISS-stadiet (The International Staging System) var I hos 43%, II hos 32% og III hos 21% af patienterne.
English: Your doctor may consider slowing the Empliciti infusion or interrupting it to manage these symptoms.
Danish: Lægen vil muligvis overveje at nedsætte infusionshastigheden for Empliciti eller afbryde infusionen for at behandle symptomerne.
English: SLAMF7 is highly expressed on multiple myeloma cells independent of cytogenetic abnormalities.
Danish: SLAMF7 er overudtrykt på myelomceller uafhængigt af cytogenetiske abnormiteter.
English: Woman of childbearing potential/Contraception in the males and females Empliciti should not be used in women of childbearing potential, unless the clinical condition of the woman requires treatment with elotuzumab.
Danish: Kvinder i den fertile alder/Kontraception hos mænd og kvinder Empliciti bør ikke anvendes til kvinder i den fertile alder, medmindre kvindens kliniske tilstand nødvendiggør behandling med elotuzumab.
English: Empliciti is used in combination with other medicines for multiple myeloma.
Danish: Empliciti anvendes sammen med anden medicin mod myelomatose.
English: SLAMF7 is found in large amounts on the surface of multiple myeloma cells and on certain cells of your immune system (natural killer cells).
Danish: SLAMF7 findes i store mængder på overfladen af myelomatoseceller og på bestemte celler i immunsystemet (naturlige dræberceller).
English: Subset description
Danish: Beskrivelse af undergrupper
English: When elotuzumab binds to SLAMF7 on the multiple myeloma or natural killer cells, it stimulates your immune system to attack and destroy the multiple myeloma cells.
Danish: Når elotuzumab binder sig til SLAMF7 på myelomatoseceller eller naturlige dræberceller, stimulerer det immunsystemet til at angribe og ødelægge myelomatosecellerne.
English: Hold the vial upright and swirl the solution by rotating the vial to dissolve the lyophilised cake.
Danish: Hold hætteglasset lodret og bland koncentratet ved at rotere hætteglasset for at opløse den lyofiliserede blok.
English: Adverse reactions reported in 682 patients with multiple myeloma who were treated with elotuzumab in 8 clinical trials are presented in Table 5.
Danish: Bivirkninger, der blev rapporteret hos 682 patienter med myelomatose, som blev behandlet med elotuzumab i 8 kliniske forsøg, er vist i tabel 5.
English: Empliciti is an IgG1 monoclonal antibody, which is principally cleared by catabolism.
Danish: Empliciti er et IgG1-monoklonalt antistof, som primært elimineres via katabolisme.
English: Women of childbearing potential should use effective contraception.
Danish: Kvinder i den fertile alder skal anvende sikker prævention.
English: Upon discontinuation of elotuzumab in combination with lenalidomide and dexamethasone or in combination with pomalidomide and dexamethasone, concentrations of elotuzumab will decrease to approximately 3% (approximately 97% washout as estimated by 5 half-lives) of the population predicted steady-state maximal serum concentration by 3 months.
Danish: Efter seponering af elotuzumab i kombination med lenalidomid og dexamethason eller i kombination med pomalidomid og dexamethason, vil koncentrationen af elotuzumab efter 3 måneder være faldet til ca. 3% (udvaskning på ca. 97% estimeret efter 5 halveringstider) af den populationsestimerede maksimale serumkoncentration ved steady-state.
English: From a microbiological point of view, the solution for infusion should be used immediately.
Danish: Ud fra en mikrobiologisk betragtning bør infusionsvæsken anvendes straks.
English: Patients with mild or moderate infusion reactions may receive Empliciti with a reduced infusion rate and close monitoring (see section 4.2 Method of administration).
Danish: Patienter med lette eller moderate infusionsreaktioner kan få Empliciti ved en reduceret infusionshastighed og under tæt monitoring (se pkt.
English: Elotuzumab is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets the SLAMF7 (signaling lymphocyte activation molecule family member 7) protein.
Danish: Elotuzumab er et immunstimulerende humaniseret IgG1-monoklonalt antistof specifikt rettet imod SLAMF7-proteinet (nummer 7 i familien af signalerende lymfocytaktiverende molekyler).
English: Demographics and baseline characteristics were well balanced between treatment arms.
Danish: Demografiske data og karakteristika ved baseline var velafbalanceret de to behandlingsarme imellem.
English: Figure 3: CA204125 Progression free survival per investigator
Danish: Figur 3: CA204125 Progressionsfri overlevelse ifølge investigator
English: Blood clots in the veins (thrombosis) Painful skin rash with blisters (shingles, zona) Night sweats
Danish: Blodpropper i venerne (trombose) Smertefuldt hududslæt med blærer (helvedesild, zoster) Nattesved
English: Empliciti is for single use only.
Danish: Empliciti er kun til engangsbrug.
English: Demographics and baseline characteristics were balanced between treatment arms.
Danish: Demografiske data og karakteristika ved baseline var afbalanceret mellem de to behandlingsarme.
English: Elotuzumab directly activates natural killer cells through both the SLAMF7 pathway and Fc receptors enhancing anti-myeloma activity in vitro.
Danish: Elotuzumab aktiverer naturlige dræberceller direkte via både SLAMF7 og Fc-receptorer og øger derved anti-myelom-aktiviteten in vitro.
English: After reconstitution, each mL of concentrate contains 25 mg elotuzumab.
Danish: Efter rekonstitution indeholder en ml koncentrat 25 mg elotuzumab.
English: Patients were refractory if they had progressed on or within 60 days of treatment with lenalidomide and a PI and on or within 60 days of their last treatment, or relapsed and refractory if they had achieved at least a partial response to previous treatment with lenalidomide and a PI but progressed within 6 months and had developed progressive disease on or within 60 days after completing their last treatment.
Danish: Patienter var refraktære hvis de havde oplevet progression indenfor 60 dages behandling med lenalidomid og en PI og indenfor 60 dage før, eller på, den sidste behandlingsdag, eller recidiveret og refraktær hvis de som minumum havde opnået et partielt respons på tidligere behandling med lenalidomid og en PI men oplevede progression indenfor 6 måneder og havde udviklet sygdom indenfor 60 dage før, eller på, den sidste behandlingsdag.
English: If the infusion reaction recurs, the Empliciti infusion must be stopped and not restarted on that day (see section 4.4).
Danish: Hvis der igen opstår infusionsreaktioner, skal infusionen afbrydes og må ikke genoptages samme dag (se pkt.
English: The flip-off seal button colour is ivory for the 300 mg presentation and blue for the 400 mg presentation.
Danish: Farven på flip-off-låget er elfenbensfarve for 300 mg styrken og blå for 400 mg styrken.
English: The geometric mean total clearance of elotuzumab at 10 mg/kg (in combination with lenalidomide and dexamethasone) at steady state is 0.194 L/day (CV: 62.9%).
Danish: Elotuzumabs geometriske, gennemsnitlige totale clearance ved 10 mg/kg (i kombination med lenalidomid og dexamethason) ved steady state er 0,194 l/dag (CV: 62,9%).
English: Table 10: CA204125 Efficacy results
Danish: Tabel 10: CA204125 Effektresultater
English: As an IgG monoclonal antibody, elotuzumab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Danish: Da elotuzumab er et IgG-monoklonalt antistof, forventes det at blive nedbrudt til små peptider og aminosyrer via katabolisme.
English: Population PK analysis suggested that the following factors had no clinically important effect on the clearance of elotuzumab: age, gender, race, baseline LDH, albumin, renal impairment, mild hepatic impairment, and coadministration with lenalidomide/dexamethasone or pomalidomide/dexamethasone.
Danish: Populationsfarmakokinetisk analyse tyder på, at følgende faktorer ikke havde nogen klinisk signifikant effekt på elotuzumab-clearance: alder, køn, race, baseline LDH, albumin, nedsat nyrefunktion, let nedsat leverfunktion og samtidig administration med lenalidomid/dexamethason eller pomalidomid/dexamethason.
English: Very severe infusion reactions (≥ Grade 3) may require permanent discontinuation of Empliciti therapy and emergency treatment.
Danish: Meget alvorlige infusionsreaktioner (≥ grad 3) kan kræve permanent seponering af Empliciti og akut behandling.
English: The median PFS per ITT was 10.25 months (95% CI: 5.59, NE) in the E-Pd arm and 4.67 months (95% CI: 2.83, 7.16) in the Pd arm. PFS and ORR were also assessed by the IRC.
Danish: Median PFS pr. ITT var 10,25 måneder (95% CI: 5,59; NE [ikke estimerbar]) i E-Pd-armen og 4,67 måneder (95% CI: 2,83; 7,16) i Pd-armen.
English: Stratified log-rank test p-valuea 1-Year PFS rate (%) [95% CI] 2-Year PFS rate (%) [95% CI] 3-Year PFS rateb(%) [95% CI] Median PFS in months [95% CI]
Danish: p værdi for stratificeret log-rank testa PFS-rate ved år 1 (%) [95% CI] PFS-rate ved år 2 (%) [95% CI] PFS-rate ved år 3b (%) [95% CI] Median PFS i måneder [95% CI]
English: Infusion reaction Infusion reactions have been reported in patients receiving elotuzumab (see section 4.8).
Danish: Der er rapporteret om infusionsreaktioner hos patienter, der har fået elotuzumab (se pkt.
English: Then invert the vial a few times in order to dissolve any powder that may be present on top of the vial or the stopper.
Danish: Vend herefter hætteglasset på hovedet et par gange for at opløse eventuelt pulver i toppen af hætteglasset eller i proppen.
English: Treatment was administered in 4-week cycles (28-day cycle) until disease progression or unacceptable toxicity.
Danish: Behandlingen blev administreret i 4-ugers cyklusser (28-dages cyklus) indtil sygdomsprogression eller uacceptabel toksicitet.
English: Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity.
Danish: Behandlingen blev administreret i 4-ugers cyklusser indtil sygdomsprogression eller uacceptabel toksicitet.
English: The most common adverse reactions (occurring in > 10% of patients) with elotuzumab treatment were infusion related reactions, diarrhoea, herpes zoster, nasopharyngitis, cough, pneumonia, upper respiratory tract infection, lymphopenia and weight decreased.
Danish: De hyppigste bivirkninger (hos > 10% af patienterne) ved elotuzumab-behandling var infusionsrelaterede reaktioner, diarre, herpes zoster, nasofaryngitis, hoste, pneumoni, infektion i de øvre luftveje, lymfopeni og vægttab.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Nattesved
English: Complete response rates in Empliciti group may be underestimated due to interference of elotuzumab monoclonal antibody with immunofixation assay and serum protein electrophoresis assay.
Danish: Rater for komplet respons i Empliciti-gruppen kan være undervurderet på grund af interferens mellem det monoklonale antistof elotozumab og immunfikseringsanalyse og serumprotein elektroforeseanalyse.
English: Of the 53 patients in CA204125 treated with Empliciti and evaluable for the presence of anti-product antibodies, 19 patients (36%) tested positive, of whom 1 patient tested persistent positive, for treatment-emergent anti-product antibodies by an ECL assay.
Danish: Af de 53 patienter i CA204125 som blev behandlet med Empliciti og analyseret for forekomst af antistoffer mod lægemidlet, blev 19 patienter (36%) testet positive, hvoraf 1 patient blev testet persisterende positiv, for antistoffer mod lægemidlet dannet i forbindelse med behandlingen ved hjælp af en elektrokemiluminescensanalyse (ECL).
English: Investigator Assessed
Danish: Investigatorvurderet
English: Elotuzumab exhibits nonlinear PK with decrease in clearance with increase in dose from 0.5-20 mg/kg.
Danish: Elotuzumab udviser non-lineær farmakokinetik med fald i clearance ved stigende doser fra 0,5-20 mg/kg.
English: Elotuzumab also targets SLAMF7 on myeloma cells and through interactions with Fc receptors on specific immune cells, promotes the killing of myeloma cells through NK cell-mediated antibody-dependent cellular cytotoxicity (ADCC) and macrophage-mediated antibody-dependant cellular phagocytosis (ADCP).
Danish: Elotuzumab er også specifikt rettet mod SLAMF7 på myelomceller og gennem interaktioner med Fc-receptorer på specifikke immunceller, fremmer drab af myelomceller via NK-celle-medieret antistofafhængig cellulær cytotoksicitet (ADCC) og makrofag-medieret antistofafhængig cellulær fagocytose (ADCP).
English: Time interval
Danish: Tidsinterval
English: Once the reaction has resolved (symptoms ≤ Grade 1), Empliciti can be restarted at the initial infusion rate of 0.5 mL/min.
Danish: Når reaktionen er aftaget (symptomer ≤ grad 1), kan Emplicitiinfusionen genoptages med en initial infusionshastighed på 0,5 ml/min.
English: Elotuzumab therapy should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.
Danish: Behandling med elotuzumab skal initieres og superviseres af speciallæger med erfaring i behandling af myelomatose.
English: If you miss a dose of Empliciti
Danish: Hvis du har glemt at få en dosis Empliciti
English: The rate of haematologic malignancies was the same between the two treatment arms.
Danish: Forekomsten af hæmatologiske maligniteter var den samme i de to behandlingsarme.
English: Nasopharyngitis 151 29.5 Upper respiratory tract infection
Danish: Nasofaryngitis 151 29,5 Øvre luftvejsinfektio n
English: Very severe infusion reactions may require permanent discontinuation of Empliciti therapy and emergency treatment.
Danish: Meget alvorlige infusionsreaktioner kan nødvendiggøre permanent seponering af Empliciti og akut behandling.
English: In clinical trials of patients with multiple myeloma, the incidence of all infections, including pneumonia, were higher in patients treated with Empliciti (see section 4.8).
Danish: I kliniske forsøg med patienter med myelomatose var forekomsten af alle infektioner, inklusive pneumoni, højere hos patienter, der blev behandlet med Empliciti (se pkt.
English: [5.59, NE]
Danish: [5,59; NE (ikke estimerbar)]
English: Calculate the dose (mg) and determine the number of vials needed for the dose (10 mg/kg or 20 mg/kg) based on patient weight.
Danish: Beregn dosis (mg) og fastlæg antallet af hætteglas, der er nødvendigt til en dosis (10 mg/kg eller 20 mg/kg), baseret på patientens kropsvægt.
English: If you stop using Empliciti
Danish: Hvis du holder op med at få Empliciti
English: Other medicines and Empliciti Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Danish: Brug af anden medicin sammen med Empliciti Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.