FrancophonIA/ELRC3.0 huggingface dataset:
English: You should not be given YESCARTA if you are allergic to any of the ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for nogen af indholdsstofferne i dette lægemiddel (angivet i punkt 6).
English: YESCARTA is a type of medicine called a “genetically modified cell therapy”.
Danish: YESCARTA er en type lægemiddel, som kaldes ”genetisk modificeret celleterapi”.
English: There is no clinical experience in patients with active HIV, HBV or HCV infection.
Danish: Der foreligger ingen klinisk erfaring hos patienter med aktiv hiv-, HBV- eller HCV-infektion.
English: Bacterial infections
Danish: Bakterielle infektioner
English: - have low blood cell levels (blood counts).
Danish: - Har lavt blodcelletal (blodtælling).
English: The safety data described in this section reflect exposure to YESCARTA in ZUMA-1, a Phase 1/2 study in which 108 patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) received CAR-positive T cells based on a recommended dose which was weightbased.
Danish: De sikkerhedsdata, der er beskrevet i dette afsnit, afspejler eksponering for YESCARTA i ZUMA-1, et fase 1/2 studie, hvor 108 patienter med recidiveret/refraktær B-celle non-Hodgkin lymfom (NHL) modtog CAR-positive T-celler baseret på en anbefalet dosis, der var vægtbaseret.
English: Peak levels of anti-CD19 CAR T cells occurred within the first 8 to 15 days after YESCARTA infusion.
Danish: Peakniveauer af anti-CD19 CAR T-celler forekom inden for de første 8 til 15 dage efter infusion af YESCARTA.
English: - have signs or symptoms of graft-versus-host disease.
Danish: - Har tegn eller symptomer på graft versus host-sygdom.
English: The availability of YESCARTA must be confirmed prior to starting the lymphodepleting regimen.
Danish: Tilgængeligheden af YESCARTA skal bekræftes inden start af det lymfocytdepleterende behandlingsregime.
English: Prior treatment with anti-CD19 therapy
Danish: Tidligere behandling med anti-CD19-behandling
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Danish: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til
English: • During YESCARTA treatment.
Danish: • Under behandlingen med YESCARTA.
English: The anti-CD19 CAR-positive viable T cells are expanded and infused back into the patient, where they can recognise and eliminate CD19-expressing target cells.
Danish: De anti-CD19 CAR-positive, levedygtige T-celler ekspanderes og infunderes tilbage i patienten igen, hvor de kan genkende og eliminere målceller, som udtrykker CD19.
English: See section 2 “YESCARTA contains sodium”.
Danish: 2 “YESCARTA indeholder natrium”.
English: - Difficulty sleeping.
Danish: Søvnproblemer.
English: Contraindications of the lymphodepleting chemotherapy must be considered.
Danish: Kontraindikationer for lymfocytdepleterende kemoterapi skal overvejes.
English: • Gently agitate the bag during YESCARTA infusion to prevent cell clumping.
Danish: • Omryst forsigtigt posen under infusion af YESCARTA for at forhindre, at cellerne klumper sammen.
English: If any of the above apply to you (or you are not sure), talk to your doctor before being given YESCARTA.
Danish: Hvis noget af det ovenstående gælder for dig (eller hvis du er i tvivl), skal du spørge lægen, før du får YESCARTA.
English: All treated (mITT) Cohort 1 + 2 (N = 101)
Danish: Alle behandlede (mITT) Kohorte 1 + 2 (N = 101)
English: Requirements for ventilator support or continuous veno-venous haemodialysis or Grade 4 organ toxicity (excluding transaminitis).
Danish: Krav om ventilatorstøtte eller kontinuerlig venovenøs hæmodialyse, eller Grad 4 organtoksicitet (med undtagelse af transaminitis).
English: YESCARTA is made specially for you as a single administration of your own modified white blood cells.
Danish: YESCARTA er fremstillet specielt til dig til en enkelt administration af dine egne modificerede leukocytter (hvide blodlegemer).
English: To minimise risk of TLS, patients with elevated uric acid or high tumour burden should receive allopurinol, or an alternative prophylaxis, prior to YESCARTA infusion.
Danish: For at mindske risikoen for TLS skal patienter med forhøjet urinsyre eller høj tumorbyrde gives allopurinol eller en alternativ profylakse, inden infusion af YESCARTA.
English: - Fluid in the lungs.
Danish: Væske i lungerne.
English: Excipients: Cryostor CS10, human albumin, sodium chloride.
Danish: Hjælpestoffer: Cryostor CS10, humant albumin, natriumchlorid.
English: • Extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells.
Danish: • Ekstrem træthed, svaghed og åndenød, som kan være symptomer på mangel på røde blodlegemer.
English: Patients who were refractory to chemotherapy or who relapsed after two or more lines of systemic therapy were generally ineligible for haematopoietic stem cell transplantation.
Danish: Patienter, som var refraktære over for kemoterapi, eller som recidiverede efter to eller flere systemiske behandlinger, var generelt uegnede til hæmatopoietisk stamcelletransplantation.
English: Do not irradiate.
Danish: Må ikke udsættes for stråling.
English: YESCARTA is not recommended if the patient has relapsed with CD19-negative disease after prior anti-CD19 therapy.
Danish: YESCARTA anbefales ikke, hvis patienten har recidiv af CD19-negativ sygdom efter tidligere anti-CD19-behandling.
English: Small clumps of cellular material should disperse with gentle manual mixing.
Danish: Små klumper af cellemateriale skal opløses ved forsigtig manuel omrystning.
English: Duration of Responsea, CR, median (range) in months
Danish: Varighed af responsa, CR, gennemsnit (tidsinterval) i måneder
English: Patients who experience Grade 2 or higher neurologic toxicities should be monitored with continuous cardiac telemetry and pulse oximetry.
Danish: Patienter, der oplever neurologiske toksiciteter af grad 2 eller højere skal monitoreres med kontinuerlig kardiel telemetri og pulsoximetri.
English: Anti-CD19 CAR T cell levels decreased toward background levels by Month 3 after infusion.
Danish: Anti-CD19 CAR T-celleniveauer aftog henimod baggrundsniveauer 3 måneder efter infusionen.
English: The initiation of B-cell recovery was first noted at Month 9, when 56% of patients had detectable B-cells.
Danish: Påbegyndelsen af B-celle restitution blev først observeret efter 9 måneder, hvor 56 % af patienterne havde påviselige B-celler.
English: Thus, the infused CAR T cells are expected to be cleared over time.
Danish: Det forventes således, at de infunderede CAR T-celler cleares med tiden.
English: • Bleeding or bruising more easily, which may be symptoms of low levels of cells in the blood known as platelets.
Danish: • Blødning eller lettere til at få blå mærker, som kan være symptomer på lave niveauer af celler i blodet kaldet blodplader.
English: YESCARTA should not be washed, spun down, and/or re-suspended in new media prior to infusion.
Danish: YESCARTA må ikke skylles, centrifugeres, og/eller genopløses i nyt medium inden infusion.
English: Other neurologic adverse reactions have been reported less frequently in clinical trials and included dysphagia (5%), myelitis (0.2%), and quadriplegia (0.2%).
Danish: Andre neurologiske bivirkninger er blevet rapporteret mindre hyppigt i kliniske forsøg og omfattede dysfagi (5 %), myelitis (0,2 %) og tetraplegi (0,2 %).
English: Symptoms require symptomatic treatment only (e.g., fever, nausea, fatigue, headache, myalgia, malaise).
Danish: Symptomer kræver kun symptomatisk behandling (f.eks. feber, kvalme, træthed, hovedpine, myalgi, utilpashed).
English: There are no data regarding the signs of overdose with YESCARTA.
Danish: Der foreligger ingen data vedrørende tegn på overdosering med YESCARTA.
English: Preparation of YESCARTA
Danish: Klargøring af YESCARTA
English: Evaluation for haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) should be considered in patients with severe or unresponsive CRS.
Danish: Evaluering for hæmofagocytisk lymfohistiocytose/makrofag aktiveringssyndrom (HLH/MAS) skal overvejes hos patienter med alvorlig CRS, eller CRS der ikke reagerer på behandling.
English: - Decreased appetite, weight loss.
Danish: Nedsat appetit, vægttab.
English: YESCARTA therapy should be initiated under the direction of and supervised by a healthcare professional experienced in the treatment of haematological malignancies and trained for administration and management of patients treated with YESCARTA.
Danish: Behandling med YESCARTA skal indledes efter anvisning fra og under opsyn af sundhedspersonale med erfaring i behandling af hæmatologiske maligniteter og uddannet i administration og behandling af patienter, der behandles med YESCARTA.
English: Muscular weakness and leukoencephalopathy are listed in the axicabtagene ciloleucel product information.
Danish: Muskelsvækkelse og leukoencefalopati er angivet i produktinformationen for axicabtagene ciloleucel.
English: It is used to treat aggressive conditions in adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) affecting your lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes and other organs in your body.
Danish: Det anvendes til at behandle aggressive sygdomme hos voksne med diffust storcellet B-celle lymfom (DLBCL) og primært mediastinalt storcellet B-celle lymfom (PMBCL), der påvirker dit lymfesysten (en del af immunsystemet) og som påvirker en type hvide blodlegemer kaldet B-lymfocytter og andre organer i din krop.
English: A single infusion bag contains approximately 68 mL of cell dispersion.
Danish: En enkelt infusionspose indeholder cirka 68 ml celledispersion.
English: The DOR was longer in patients who achieved CR, as compared to patients with a best response of partial response (PR).
Danish: DOR var længere hos patienter, som opnåede CR sammenlignet med patienter, hvis bedste respons var et delvist respons (PR).
English: Patients with refractory disease to ≥ 2 prior lines of therapy
Danish: Patienter med refraktær sygdom over for ≥ 2 tidligere behandlinger
English: - Fever or chills.
Danish: Feber eller kulderystelser.
English: In the 24-month follow-up analysis, based on the mITT population (results from an independent review committee), the ORR and the CR rate were 74% and 54%, respectively.
Danish: I 24-måneders opfølgningsanalysen, der var baseret på mITT-populationen (resultater fra en uafhængig bedømmelseskomité), var ORR og CR-raten på henholdsvis 74 % og 54 %.
English: Severe CRS, including life-threatening and fatal reactions, was very commonly observed with YESCARTA with a time to onset of 1 to 12 days (see section 4.8).
Danish: Alvorlig CRS, herunder livstruende og dødelige reaktioner, blev observeret til at være meget almindeligt med YESCARTA med start 1 til 12 dage efter infusion (se pkt.
English: - Leakage of fluids from blood vessels into surrounding tissue.
Danish: Lækage af væske fra blodkar til omgivende væv.
English: Patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection
Danish: Patienter, som har infektion med human immundefekt virus (hiv), hepatitis B-virus (HBV) og hepatitis C-virus (HCV)
English: Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted.
Danish: Overlappende kemoterapi mellem leukaferese og lymfocytdepleterende kemoterapi var ikke tilladt.
English: - Infections in the blood caused by fungi.
Danish: Infektioner i blodet forårsaget af svampe.
English: Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.
Danish: Overvej ikke-sederende antiepileptisk medicin (f.eks. levetiracetam) som anfaldsprofylakse.
English: No carcinogenicity or genotoxicity studies have been conducted with YESCARTA.
Danish: Ingen karcinogenicitets- eller genotoksicitetsundersøgelser er blevet udført med YESCARTA.
English: The infection will be treated before the YESCARTA infusion.
Danish: Infektionen vil blive behandlet inden infusion med YESCARTA.
English: Following YESCARTA treatment, the proportion of patients with detectable B-cells decreased: 20% had detectable B-cells at Month 3, and 22% had detectable B-cells at Month 6.
Danish: Efter behandling med YESCARTA blev andelen af patienter med påviselige B-celler reduceret: 20 % havde påviselige B-celler efter 3 måneder, og 22 % havde påviselige B-celler efter 6 måneder.
English: Monitor patients daily for signs and symptoms of CRS for at least 10 days following infusion at the qualified clinical facility.
Danish: Monitorér patienterne dagligt for tegn og symptomer på CRS i mindst 10 dage efter infusion på en kvalificeret klinik.
English: Due to the on-target, off-tumour effect of YESCARTA, a period of B-cell aplasia is expected following treatment.
Danish: Som følge af YESCARTA's virkning på målcellerne uden for tumoren forventes en periode med Bcelle aplasi efter behandling.
English: Grade 3 or higher (severe, life-threatening, or fatal) infections occurred in 26% of patients.
Danish: Infektioner af grad 3 eller højere (alvorlig, livstruende eller dødelig) forekom hos 26 % af patienterne.
English: A causal relationship between dysphagia and axicabtagene ciloleucel was confirmed, based on the evidence from 15 post-marketing cases and 4 clinical trial cases of dysphagia.
Danish: En årsagssammenhæng mellem dysfagi og axicabtagene ciloleucel blev bekræftet på baggrund af evidensen fra 15 tilfælde af dysfagi efter markedsføringen og 4 tilfælde i kliniske studier.
English: * Dysphagia has been reported in the setting of neurologic toxicity and encephalopathy
Danish: *Dysfagi er blevet rapporteret i forbindelse med neurologisk toksicitet og encefalopati.
English: - Confusion.
Danish: Forvirring.
English: Of the 52 patients who achieved CR, 7 patients had SD and 9 had PR at their initial tumour assessment and converted to CR as late as 6.5 months.
Danish: Af de 52 patienter, som opnåede CR, havde 7 patienter SD og 9 havde PR ved deres første tumorvurdering og konverterede til CR så sent som efter 6,5 måneder.
English: Patients with a history of CNS disorders (such as seizures or cerebrovascular ischemia), cardiac ejection fraction of less than 50% or room air oxygen saturation of less than 92%, or autoimmune disease requiring systemic immunosuppression were ineligible.
Danish: Patienter med en anamnese med sygdom i centralnervesystemet (som f.eks. krampeanfald eller cerebrovaskulær iskæmi), en kardiel ejection fraction på under 50 % eller iltmætning på under 92 % i almindelig luft, eller som har autoimmun sygdom, der kræver systemisk immunsuppression, var uegnede.
English: Patients with a history of CNS disorders such as seizures or cerebrovascular ischaemia may be at increased risk.
Danish: Patienter med en anamnese med sygdom i centralnervesystemet, såsom krampeanfald eller cerebrovaskulær iskæmi, kan have øget risiko.
English: YESCARTA is intended for autologous use only (see section 4.4).
Danish: YESCARTA er udelukkende beregnet til autolog anvendelse (se pkt.
English: The MAH must ensure on-site, immediate access to 4 doses of tocilizumab for each patient as CRS management medication prior to treating patients.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at der er umiddelbar adgang på stedet til 4 doser tocilizumab for hver patient som CRS-behandlingsmedicin, inden patienter tages i behandling.
English: The median time from leukapheresis to product delivery was 17 days (range: 14 to 51 days), and the median time from leukapheresis to infusion was 24 days (range: 16 to 73 days).
Danish: Den gennemsnitlige tid fra leukaferese til levering af lægemidlet var 17 dage (tidsinterval: 14 til 51 dage), og den gennemsnitlige tid fra leukaferese til infusion var 24 dage (tidsinterval: 16 til 73 dage).
English: Immunoglobulin levels should be monitored after treatment with YESCARTA and managed using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.
Danish: Immunglobulinniveauer efter behandling med YESCARTA bør monitoreres og behandles ved at følge infektionsforholdsregler, anvende antibiotikum-profylakse og immunglobulinsubstitution.
English: For storage conditions after thawing of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter optøning af lægemidlet, se pkt.
English: Pre-treatment (lymphodepleting chemotherapy)
Danish: Forbehandling (lymfocytdepleterende kemoterapi)
English: If visible cell clumps remain, continue to gently mix the contents of the bag.
Danish: Hvis der stadig er synlige celleklumper, skal posens indhold forsigtigt omrystes yderligere.
English: No clinical data on the effect of YESCARTA on fertility are available.
Danish: Der foreligger ingen kliniske data vedrørende effekten af YESCARTA på fertilitet.
English: Severe neurologic adverse reactions have been very commonly observed in patients treated with YESCARTA, which could be life-threatening or fatal (see section 4.8).
Danish: Alvorlige neurologiske bivirkninger er blevet observeret til at være meget almindelige hos patienter behandlet med YESCARTA, og disse kan være livstruende eller dødelige (se pkt.
English: Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs or symptoms of CRS and/or neurologic events.
Danish: Læger skal overveje hospitalsindlæggelse i de første 10 dage efter infusion eller ved de første tegn eller symptomer på CRS og/eller neurologiske hændelser.
English: Patients with CNS lymphoma, a history of allogeneic stem cell transplantation (SCT) or prior anti-CD19 CAR or other genetically modified T-cell therapy were excluded.
Danish: Patienter med lymfom i CNS, en anamnese med allogen stamcelletransplantation (SCT) eller tidligere anti-CD19 CAR eller anden genetisk modificeret T-celle-behandling blev ekskluderet.
English: This trend of B-cell recovery continued over time, as 64% of patients had detectable B-cells at Month 18, and 77% of patients had detectable B-cells at Month 24.
Danish: Denne tendens til B-celle restitution fortsatte over tid, idet 64 % af patienterne havde påviselige B-celler efter 18 måneder, og 77 % af patienterne havde påviselige B-celler efter 24 måneder.
English: In the 12-month follow-up analysis (Table 5), the ORR was 72% and the CR rate was 51%.
Danish: I 12-måneders opfølgningsanalysen (Tabel 5) var ORR 72 %, og CR var 51 %.
English: DLBCL in ZUMA-1 included patients with DLBCL NOS, other DLBCL subtypes, and high-grade B-cell lymphoma (HGBCL) based on the 2016 WHO-classification.
Danish: DLBCL i ZUMA-1 inkluderede-patienter med DLBCL NOS, andre DLBCL undertyper og high-grade B-cellelymfom (HGBCL) baseret på WHO-klassifikationen fra 2016.
English: Grade 3 or higher prolonged cytopenias following YESCARTA infusion occurred very commonly and included thrombocytopenia, neutropenia, and anaemia.
Danish: Vedvarende cytopenier af grad 3 eller højere efter infusion af YESCARTA forekom meget almindeligt og inkluderede trombocytopeni, neutropeni og anæmi.
English: Fatal and serious cases of cerebral oedema have been reported in patients treated with YESCARTA.
Danish: Dødelige og alvorlige tilfælde af hjerneødem er blevet rapporteret hos patienter behandlet med YESCARTA.
English: Before infusion, the patient's identity must match the patient identifiers on the YESCARTA infusion bag and cassette.
Danish: Inden infusion skal patientens identitet matche patientidentifikationerne på YESCARTAinfusionsposen og kassetten.
English: Patients who experience Grade 2 or higher CRS (e.g. hypotension, not responsive to fluids, or hypoxia requiring supplemental oxygenation) should be monitored with continuous cardiac telemetry and pulse oximetry.
Danish: Patienter, der oplever CSR af grad 2 eller højere (f.eks. hypotension, reagerer ikke på væsker, eller hypoksi, der kræver supplerende oxygenering), skal monitoreres med kontinuerlig kardiel telemetri og pulsoximetri.
English: Efficacy was based on 101 patients in phase 2, including histologically confirmed DLBCL (N = 77), PMBCL (N = 8), or DLBCL arising from follicular lymphoma, (N = 16) based on the 2008 WHO-classification.
Danish: Virkning var baseret på 101 patienter i fase 2, som inkluderede patienter med histologisk bekræftet DLBCL (n = 77), PMBCL (n = 8) eller DLBCL transformeret fra follikulært lymfom (n = 16) baseret på WHO-klassifikationen fra 2008.
English: • Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential CRS, neurologic events and other toxicities.
Danish: • Patienterne skal monitoreres dagligt i de første 10 dage efter infusion for tegn og symptomer på potentielt CRS, neurologiske bivirkninger og andre toksiciteter.
English: Contents of the pack and other information What YESCARTA contains
Danish: Pakningsstørrelser og yderligere oplysninger YESCARTA indeholder
English: Eleven percent (11%) of patients experienced Grade 3 or higher (severe, life-threatening, and fatal) CRS.
Danish: Elleve procent (11 %) af patienterne oplevede grad 3 eller højere (alvorlig, livstruende og dødelig) CRS.
English: Medicines given before YESCARTA treatment
Danish: Medicin der gives inden behandling med YESCARTA
English: • Check for hepatitis B, hepatitis C or HIV infection.
Danish: • Kontrollere for hepatitis B-, hepatitis C- eller hiv-infektion.
English: Thirty-two percent (32%) of patients experienced Grade 3 or higher (severe or life-threatening) adverse reactions.
Danish: Toogtredive procent (32 %) af patienterne oplevede grad 3 eller højere (alvorlige eller livstruende) bivirkninger.
English: The immunogenicity of YESCARTA has been evaluated using an enzyme-linked immunosorbent assay (ELISA) for the detection of binding antibodies against FMC63, the originating antibody of the anti-CD19 CAR.
Danish: Immunogeniciteten af YESCARTA er blevet undersøgt ved hjælp af Enzyme Linked ImmunoSorbent Assay (ELISA) til detektion af antistoffer mod FMC63, som er det oprindelige antistof af anti-CD19 CAR.
English: The median duration was 13 days (range: 1 to 191 days).
Danish: Den gennemsnitlige varighed var 13 dage (interval: 1 til 191 dage).
English: YESCARTA is stable at room temperature for up to 3 hours after thaw.
Danish: YESCARTA er stabil ved stuetemperatur i op til 3 timer efter optøning.
English: YESCARTA comprises engineered human T cells, therefore there are no representative in vitro assays, ex vivo models, or in vivo models that can accurately address the toxicological characteristics of the human product.
Danish: Der er derfor ingen repræsentative in vitro assays, ex vivo modeller eller in vivo modeller, som nøjagtigt kan undersøge de toksikologiske karakteristika af det humane lægemiddel.
English: All leukapheresed (ITT) Cohort 1 + 2 (N = 111)
Danish: Alle leukafereserede (ITT) Kohorte 1 + 2 (N = 111)
English: Administer methylprednisolone 1 mg/kg intravenously twice daily or equivalent dexamethasone (e.g., 10 mg intravenously every 6 hours).
Danish: Administrér methylprednisolon 1 mg/kg intravenøst to gange dagligt eller tilsvarende dexamethason (f.eks. 10 mg intravenøst hver 6. time).
English: No interaction studies have been performed with YESCARTA.
Danish: Der er ikke udført interaktionsstudier med YESCARTA.
English: YESCARTA is stable for 1 year when stored frozen in the vapour phase of liquid nitrogen (≤ -150 ˚C).
Danish: YESCARTA er stabilt i 1 år ved opbevaring nedfrosset i dampformen af flydende kvælstof (≤150 °C).
English: B-cell aplasia leading to hypogammaglobulinaemia can occur in patients receiving treatment with YESCARTA.
Danish: B-celle aplasi, som forårsager hypogammaglobulinæmi, kan forekomme hos patienter, som modtager behandling med YESCARTA.