FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 6 Study C2201: Efficacy results in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
Danish: Tabel 6 Studie C2201: Effektresultater hos voksne patienter med recidiverende eller refraktært diffust storcellet B-celle lymfom (DLBCL), efter to eller flere systemiske behandlingslinjer
English: Grade 3 and 4 adverse reactions were more often observed within the initial 8 weeks post-infusion (83% of patients) compared to after 8 weeks post-infusion (46% of patients).
Danish: Bivirkninger af grad 3 og 4 blev observeret oftere inden for de første 8 uger efter infusion (83 % af patienterne) sammenlignet med efter 8 uger efter infusion (46 % af patienterne).
English: A total of 72 out of 75 patients who received Kymriah infusion also received lymphodepleting chemotherapy after enrolment and prior to infusion of a single dose of Kymriah (see section 4.2 for condition of lymphodepleting chemotherapy).
Danish: I alt 72 ud af de 75 patienter, der fik infusion med Kymriah, fik også lymfodepleterende kemoterapi efter inklusion og forud for infusionen af en enkelt dosis Kymriah (se pkt.
English: Additional organ system adverse reactions, including transient cardiac insufficiency and arrhythmia, renal insufficiency, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT) and elevated bilirubin have been observed.
Danish: Yderligere organsystem-bivirkninger, fx forbigående hjerteinsufficiens og hjertearytmi, nyreinsufficiens, forhøjet aspartataminotransferase (ASAT), forhøjet alaninaminotransferase (ALAT) og forhøjet niveau af bilirubin, er blevet observeret.
English: - For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T cells (non-weight based).
Danish: - Til patienter, der vejer over 50 kg: 0,1 til 2,5 x 108 CAR-positive levende T-celler (ikke vægtbaseret).
English: Arrhythmia includes atrial fibrillation and supraventricular tachycardia.
Danish: Arytmi omfatter atrieflimmer og supraventrikulær takykardi.
English: • Thirst
Danish: • Tørst
English: Immunoglobulin levels should be assessed in newborns of mothers treated with Kymriah.
Danish: Immunoglobulin-niveauer bør vurderes hos nyfødte af mødre, der er blevet behandlet med Kymriah.
English: This medicine contains genetically-modified blood cells.
Danish: Dette lægemiddel indeholder genetisk modificerede blodceller.
English: Table 5 Study C2201: Baseline information across the enrolled and the infused patient populations
Danish: Tabel 5 Studie C2201: Baseline oplysninger på tværs af inkluderede og infunderede patientpopulationer
English: CRi (complete remission with incomplete blood count recovery) was defined as <5% of blasts in the bone marrow, circulating blasts in blood should be <1%, no evidence of extramedullary disease, and without full recovery of peripheral blood counts with or without blood transfusion.
Danish: CRi (komplet remission med ufuldstændig normalisering af blodtal) var defineret som <5 % blaster i knoglemarven, cirkulerende blaster i blodet skal være <1 %, ingen påvisning af ekstramedullær sygdom og uden fuldstændig normalisering af antallet af perifere blodceller med eller uden blodtransfusion.
English: Following administration of Kymriah, breast-feeding should be discussed with the treating physician.
Danish: Efter administration af Kymriah bør amning drøftes med den behandlende læge.
English: • Involuntary tremor
Danish: • Ufrivillige rystelser
English: When the full volume of Kymriah has been infused, the infusion bag should be rinsed with 10 to 30 mL sodium chloride 9 mg/mL (0.9%) solution for injection by back priming to ensure as many cells as possible are infused into the patient.
Danish: Når det fulde volumen af Kymriah er blevet infunderet, bør infusionsposen skylles med 10 til 30 ml natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion ved at tilbage-prime for at sikre, at så mange celler som muligt infunderes ind i patienten.
English: The safety and efficacy of Kymriah treatment in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who received ≥2 lines of chemotherapy, including rituximab and anthracycline, or relapsed following autologous haematopoietic stem cell transplantation (HSCT), was evaluated in an open-label, pivotal, single-arm study.
Danish: Sikkerheden og virkningen af behandling med Kymriah hos voksne patienter med recidiverende eller refraktært (r/r) diffust storcellet B-celle lymfom (DLBCL), som fik ≥2 linjer kemoterapi, inklusive rituximab og anthracyclin eller som recidiverede efter autolog hæmatopoietisk stamcelletransplantation (HSCT), blev vurderet i et ublindet, pivotalt studie med en enkelt arm.
English: • Dry mouth, sore mouth, bleeding in the mouth, inflammation in the gums
Danish: • Tør mund, ømhed i munden, blødning i munden, betændelse i tandkødet
English: Prior stem-cell transplantation - n (%)
Danish: Tidligere stamcelletransplantation - n (%)
English: If the infusion bag appears to have been damaged or to be leaking, it should not be infused and should be disposed of according to local biosafety procedures (see section 4.2.
Danish: Hvis infusionsposen ser ud til at være beskadiget eller lække, bør den ikke bruges og skal bortskaffes i henhold til lokale retningslinjer for biosikkerhed (se pkt.
English: Encephalopathy includes depressed level of consciousness, mental status changes, automatism, cognitive disorder, confusional state, disturbance in attention, encephalopathy, posterior reversible encephalopathy syndrome, somnolence, lethargy, memory impairment, metabolic encephalopathy and thinking abnormal.
Danish: Encefalopati omfatter nedsat bevidsthedsniveau, ændringer i mental status, automatisme, kognitive forstyrrelser, forvirringstilstand, opmærksomhedsforstyrrelser, encefalopati, posteriort reversibelt encefalopati-syndrom, somnolens, letargi, hukommelsesbesvær, metabolisk encefalopati og abnorme tanker.
English: Hypogammaglobulinaemia
Danish: Hypogammaglobulinæmi
English: • Pale skin, weakness, breathlessness
Danish: • Bleg hud, svaghed, åndenød
English: The infusion bag(s) should be examined for any breaks or cracks prior to thawing.
Danish: Infusionsposerne skal undersøges for eventuelle brud eller revner inden optøning.
English: In DLBCL patients severe infections (Grade 3 and higher), which can be life-threatening or fatal, occurred in 32% of patients.
Danish: Hos DLBCL-patienter forekom der svære infektioner (grad 3 og højere), som kan være livstruende eller have dødelig udgang, hos 32 % af patienterne.
English: Concomitant disease
Danish: Samtidig sygdom
English: Decreased appetite Hypokalaemia Hypophosphataemia Hypocalcaemia Hypomagnesaemia Hypoalbuminaemia Hyperuricaemia Hyperglycaemia
Danish: Nedsat appetit Hypokaliæmi Hypofosfatæmi Hypocalcæmi Hypomagnesiæmi Hypoalbuminæmi Hyperurikæmi Hyperglykæmi
English: Precautions to be taken before handling or administering the medicinal product This medicinal product contains genetically modified human blood cells.
Danish: Sikkerhedsforanstaltninger, der skal tages inden administration af lægemidlet Dette lægemiddel indeholder genetisk modificerede humane blodceller.
English: In B-cell ALL patients severe infections (Grade 3 and higher), which can be life-threatening or fatal, occurred in 44% of patients after Kymriah infusion.
Danish: Hos B-celle ALL-patienter forekom der svære infektioner (grad 3 og højere), som kan være livstruende eller have dødelig udgang, hos 44 % af patienterne efter infusion af Kymriah.
English: Pregnancy after Kymriah therapy should be discussed with the treating physician.
Danish: Graviditet efter behandling med Kymriah bør drøftes med den behandlende læge.
English: Post-authorisation efficacy study (PAES): In order to further evaluate the efficacy of Kymriah in patients with relapsed/refractory DLBCL, the applicant should conduct and submit a prospective, observational study in patients with r/r DLBCL based on data from registry with efficacy outcome measures in line with study C2201, including details of the manufacturing turnaround time (i.e. time from last relapse or confirmed refractory status, time from decision to treat, and time from leukapheresis to infusion).
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For at evaluere effekten af Kymriah hos patienter med recidiverende/refraktær DLBCL, skal ansøgeren gennemføre og indsende et prospektivt, observatorisk studie hos patienter med r/r DLBCL, baseret på data fra et register med effektmålsresultater på linje med studie C2201, inklusive detaljer om fremstillingens turnaround tid (dvs. tid fra sidste recidiv eller bekræftet refraktær status, tid fra beslutning til behandling, og tid fra leukaferese til infusion).
English: If you have any questions about how Kymriah works or why this medicine has been prescribed for you, ask your doctor.
Danish: Tal med lægen, hvis du har spørgsmål til, hvordan Kymriah virker, eller hvorfor dette lægemiddel er blevet ordineret til dig.
English: • You are pregnant, think you may be pregnant, or plan to become pregnant (see sections
Danish: • Du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid (se afsnittene “Graviditet og amning” og “Prævention for kvinder og mænd” nedenfor).
English: Non-interventional post-authorisation safety study (PASS): In order to further characterise the safety - including long-term safety - of Kymriah, the applicant should conduct and submit a study based on data from a disease registry in ALL and DLBCL patients.
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS): For en yderligere karakterisering af sikkerheden - inklusive langtidsdata for sikkerheden - for Kymriah, skal ansøgeren gennemføre og indsende et studie baseret på data fra et sygdomsregister hos ALL- og DLBCL-patienter.
English: In paediatric and young adult B-cell ALL patients, tisagenlecleucel has been shown to be present in the blood and bone marrow beyond 2 years (study B2101J).
Danish: Hos pædiatriske og unge voksne B-celle ALL-patienter har tisagenlecleucel vist sig at være til stede i blodet og knoglemarven i mere end 2 år (studie B2101J).
English: Dosage in adult DLBCL patients - 0.6 to 6 x 108 CAR-positive viable T cells (non-weight based).
Danish: Dosering hos voksne patienter med DLBCL - 0,6 til 6 x 108 CAR-positive levende T-celler (ikke vægtbaseret).
English: Blood fibrinogen decreased Serum ferritin increased Blood alkaline phosphatase increased Fibrin D dimer increased Prothrombin time prolonged a)
Danish: Forlænget aktiveret partiel tromboplastintid Nedsat fibrinogen i blodet Forhøjet serumferritin Forhøjet basisk fosfatase i blodet Forhøjet fibrin D-dimer Forlænget protrombintid a)
English: Overall survival (OS)8 % survival probability at 6 months % survival probability at 12 months Median (months) (95% CI)
Danish: Samlet overlevelse (OS)8 % overlevelsessandsynlighed efter 6 måneder % overlevelsessandsynlighed efter 12 måneder Median (måneder) (95 % CI)
English: Key baseline information for enrolled and infused patients is presented in Table 3.
Danish: Vigtige baseline-oplysninger hos inkluderede og infunderede patienter er vist i tabel 3.
English: Table 3 Study B2202: Baseline information across the enrolled and the infused patient population
Danish: Tabel 3 Studie B2202: Baseline-oplysninger på tværs af inkluderede og infunderede patientpopulationer
English: Hypogammaglobulinaemia includes immunoglobulins decreased, blood immunoglobulin A decreased, blood immunoglobulin G decreased, blood immunoglobulin M decreased, immunodeficiency common variable and hypogammaglobulinaemia.
Danish: Hypogammaglobulinæmi omfatter nedsatte immunglobulinniveauer, nedsat blodimmunglobulin A-niveau, nedsat blodimmunglobulin G-niveau, nedsat blodimmunglobulin M-niveau, almindelig variabel immundefekt og hypogammaglobulinæmi.
English: Other medicines and Kymriah
Danish: Brug af anden medicin sammen med Kymriah
English: In paediatric and young adult B-cell ALL patients, manifestations of encephalopathy and/or delirium occurred in 40% of patients (13% were Grade 3 or 4) within 8 weeks after Kymriah infusion.
Danish: Hos pædiatriske og unge voksne B-celle ALL-patienter opstod der tegn på encefalopati og/eller delirium hos 40 % af patienterne (13 % var af grad 3 eller 4) inden for 8 uger efter infusion af Kymriah.
English: Post-authorisation efficacy study (PAES): In order to further characterise the long-term efficacy and safety of Kymriah in relapsed/refractory DLBCL, the applicant should submit the 24 months follow-up for patients in the main Cohort and 24 months follow-up of all infused patients from study C2201.
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For en yderligere karakterisering af langtidsdata for effekten og sikkerheden af Kymriah hos recidiverende/refraktær DLBCL, skal ansøgeren indsende 24 måneders opfølgning for patienter i hovedkohorten og 24 måneders opfølgning på alle infunderede patienter fra studiet C2201.
English: Local biosafety guidelines should be followed for unused medicine or waste material.
Danish: Lokale retningslinjer for biosikkerhed skal følges for håndtering af overskydende lægemiddel eller affald heraf.
English: • Failure of multiple organs
Danish: • Multiorgansvigt
English: All patients had leukapheresis starting material collected and cryopreserved prior to or during study entry.
Danish: Alle patienter fik leukaferese-startmateriale indsamlet og kryopræserveret forud for eller under indtrædelsen i studiet.
English: Tachycardia includes sinus tachycardia and tachycardia.
Danish: Takykardi omfatter sinustakykardi og takykardi.
English: Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah.
Danish: Vaccination med levende virale vacciner anbefales ikke i mindst 6 uger før start af lymfodepleterende kemoterapi, under behandling med Kymriah og indtil immunsystemets effekt er genoprettet efter behandling med Kymriah.
English: Post-authorisation efficacy study (PAES): In order to further evaluate the efficacy and safety of Kymriah in ALL patients below the age of 3 years, the applicant should conduct and submit a study based on data from a disease registry in ALL patients.
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For at evaluere yderligere på effekten og sikkerheden af Kymriah hos ALL-patienter under 3 år, skal ansøgeren gennemføre og indsende et studie baseret på data fra et sygdomsregister hos ALL-patienter.
English: Test and checks
Danish: Undersøgelser og overvågning
English: • problems such as altered or decreased consciousness, delirium, confusion, agitation, seizures, difficulty speaking and understanding speech, loss of balance.
Danish: • problemer, som fx ændret eller nedsat bevidsthed, febervildelse, forvirring, ophidselse, krampeanfald, besvær med at tale og forstå tale, dårlig balance.
English: Influenza-like illness Multiple organ dysfunction syndrome
Danish: Influenzalignende sygdom Multiorgansvigt
English: Lymphodepleting chemotherapy is recommended to be administered before Kymriah infusion unless the white blood cell (WBC) count within one week prior to infusion is ≤1,000 cells/μL.
Danish: Det anbefales at administrere lymfodepleterende kemoterapi før infusion af Kymriah, medmindre antallet af hvide blodceller (WBC) er ≤1.000 celler/μl inden for én uge før infusionen.
English: Patients with active CNS leukaemia
Danish: Patienter med aktiv leukæmi i CNS
English: This will show if you are likely to develop a condition called tumour lysis syndrome.
Danish: om der er sandsynlighed for, at du udvikler en tilstand, som kaldes tumorlysesyndrom.
English: If the patient experienced a previous Grade 4 haemorrhagic cystitis with cyclophosphamide, or demonstrated a chemorefractory state to a cyclophosphamide-containing regimen administered shortly before lymphodepleting chemotherapy, then the following should be used: - Bendamustine (90 mg/m2 intravenous daily for 2 days).
Danish: Hvis patienten oplevede en forudgående hæmoragisk cystitis af grad 4 med cyclophosphamid eller udviste en kemorefraktær tilstand i forbindelse med et cyclophosphamid-indeholdende regime administreret kort tid før lymfodepleterende kemoterapi, bør følgende anvendes: - Bendamustin (90 mg/m2 intravenøst daglig i 2 dage).
English: Febrile neutropenia Leukopenia Lymphopenia Anaemia
Danish: Febril neutropeni Leukopeni Lymfopeni Anæmi
English: Tumour lysis syndrome (TLS)
Danish: Tumorlysesyndrom (TLS)
English: There is no apparent relationship between dose and AUC0-28d or Cmax.
Danish: AUC0-28d og Cmax hænger tilsyneladende ikke sammen med dosis.
English: Infections are known to complicate the course and management of concurrent cytokine release syndrome.
Danish: Infektioner vides at komplicere forløbet og håndteringen af sideløbende cytokinfrigivelsessyndrom.
English: Neurological adverse reactions
Danish: Neurologiske bivirkninger
English: In Study B2202, 43% female and 57% male patients and in Study C2201 39% female and 61% male patients received Kymriah.
Danish: Kønsfordelingen af patienter der fik Kymriah var 43 % kvindelige og 57 % mandlige patienter i studie C2201 og 39 % kvindelige og 61 % mandlige patienter i studie C2201.
English: Tisagenlecleucel is an autologous, immunocellular cancer therapy which involves reprogramming a patient's own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19 expressing cells.
Danish: Tisagenlecleucel er en autolog, cellulær cancerimmunterapi, som involverer omprogrammering af patientens egne T-celler med et transgen, der koder for en kimær antigenreceptor (CAR) til at identificere og eliminere CD19-udtrykkende celler.
English: T-cell immunogenicity responses were not observed in paediatric and young adult B-cell ALL and adult r/r DLBCL patients.
Danish: Der blev ikke observeret T-celle immunogenicitetsrespons hos pædiatriske og unge voksne patienter med B-celle ALL og voksne patienter r/r DLBCL.
English: Cytokine release syndrome, including fatal or life-threatening events, has been frequently observed after Kymriah infusion (see section 4.8).
Danish: Cytokinfrigivelsessyndrom, herunder livstruende hændelser og dødsfald, er hyppigt blevet observeret efter infusion af Kymriah (se pkt.
English: The pivotal study (C2201) is a multicentre, single-arm phase II study in adult patients with relapsed or refractory DLBCL.
Danish: Det pivotale studie (C2201) er et fase II-multicenterstudie med en enkelt arm hos voksne patienter med recidiverende eller refraktært DLBCL.
English: If you think you may be allergic, ask your doctor for advice.
Danish: Spørg lægen til råds, hvis du tror, at du kan være allergisk.
English: Table 4 Study B2202: Efficacy results in paediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukaemia (ALL)
Danish: Tabel 4 Studie B2202: Effektresultater hos pædiatriske og unge voksne patienter med recidiverende/refraktær B-celle akut lymfoblastær leukæmi (ALL)
English: See section 2, “Kymriah contains sodium, dimethylsulfoxide (DMSO) and dextran 40”.
Danish: Se afsnit 2 ”Kymriah indeholder natrium, dimethylsulfoxid (DMSO) og dextran 40”.
English: Assessment of immunoglobulin levels is indicated in newborns of mothers treated with Kymriah.
Danish: Bestemmelse af immunglobulinniveauer er indiceret hos nyfødte, hvis mødre er blevet behandlet med Kymriah.
English: Infused N=111 n (%)
Danish: Infunderede N=111 n (%)
English: Other manifestations included seizures, aphasia and speech disorder.
Danish: Andre manifestationer inkluderer krampeanfald, afasi og taleforstyrrelser.
English: Infections and infestationsa)
Danish: Infektioner og parasitære sygdommea)
English: Kymriah should be administered as an intravenous infusion through latex-free intravenous tubing without a leukocyte depleting filter, at approximately 10 to 20 mL per minute by gravity flow.
Danish: Kymriah bør administreres som en intravenøs infusion gennem latexfrie intravenøse-slanger uden et leukocytfilter ved en fri strømningshastighed på cirka 10 til 20 ml pr. minut, ved hjælp af tyngdekraftstrømmen.
English: Serious infections, including life-threatening or fatal infections, occurred frequently in patients after Kymriah infusion (see section 4.8).
Danish: Alvorlige infektioner, herunder livstruende infektioner eller infektioner med dødelig udgang, er hyppigt forekommet efter infusion af Kymriah (se pkt.
English: Kymriah was administered in a qualified Kymriah treatment centre in an inpatient and outpatient setting.
Danish: Kymriah blev administreret i et kvalificeret Kymriah behandlingscenter både som ambulant behandling og under indlæggelse.
English: • Abdominal pain, constipation, diarrhoea
Danish: • Mavesmerter, forstoppelse, diarré
English: Not estimable.
Danish: Kan ikke estimeres.
English: Post-authorisation efficacy study (PAES): In order to further characterise the long-term efficacy and safety of Kymriah in relapsed/refractory DLBCL, the applicant should submit the results of study CCTL019H2301 - open-label, Phase III study of Kymriah versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For en yderligere karakterisering af langtidsdata for effekten og sikkerheden af Kymriah hos recidiverende/refraktær DLBCL, skal ansøgeren indsende studieresultaterne af CCTL019H2301 - et åbent, fase III-studie med Kymriah versus standardbehandling hos voksne patienter med recidiverende eller refraktær, aggressiv B-celle non-Hodgkin-lymfom.
English: Symptoms of cytokine release syndrome may include high fever, rigors, myalgia, arthralgia, nausea, vomiting, diarrhoea, diaphoresis, rash, anorexia, fatigue, headache, hypotension, encephalopathy, dyspnoea, tachypnoea, and hypoxia.
Danish: Symptomer på cytokinfrigivelsessyndrom kan omfatte høj feber, kulderystelser, myalgi, artralgi, kvalme, opkastning, diarré, diaforese, udslæt, anoreksi, træthed, hovedpine, hypotension, encefalopati, dyspnø, takypnø og hypoksi.
English: % event free probability at 6 months Median (months) (95% CI)
Danish: % hændelsesfri sandsynlighed efter 6 måneder Median (måneder) (95 % CI)
English: If you have leukaemia this might include fever, feeling weak, bleeding gums, bruising.
Danish: Hvis du har leukæmi, kan det betyde feber, svaghed, blødende tandkød, blå mærker.
English: See Table 4 for efficacy results from this study.
Danish: Effektresultater fra dette studie er vist i tabel 4.
English: Kymriah is for autologous use only.
Danish: Kymriah er udelukkende til autolog anvendelse.
English: NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 x 106 - 6 x 108 cells dispersion for infusion
Danish: LÆGEMIDLETS NAVN Kymriah 1,2 x 106 - 6 x 108 celler infusionsvæske, dispersion
English: Prior transplantation did not impact the expansion/persistence of Kymriah in paediatric and young adult B-Cell ALL patients or DLBCL patients.
Danish: Tidligere transplantation havde ingen indvirkning på ekspansionen/persistensen af Kymriah hos hverken pædiatriske og unge voksne B-celle ALL-patienter eller DLBCL-patienter.
English: Other symptoms of cytokine release syndrome are difficulty breathing, nausea, vomiting, diarrhoea, muscle pain, joint pain, low blood pressure, or dizziness/light-headedness.
Danish: Andre symptomer på cytokinfrigivelsessyndrom er åndedrætsbesvær, kvalme, opkasning, diarré, muskelsmerter, ledsmerter, lavt blodtryk eller svimmelhed/ørhed.
English: The most common non-haematological adverse reactions were cytokine release syndrome (58%), infections (54%), pyrexia (35%), diarrhoea (32%), nausea (29%), hypotension (26%) and fatigue
Danish: De mest almindelige ikke-hæmatologiske bivirkninger var cytokinfrigivelsessyndrom (58 %), infektioner (54 %), pyreksi (35 %), diarré (32 %), kvalme (29 %), hypotension (26 %) og træthed
English: The most common Grade 3 and 4 non-haematological adverse reaction was cytokine release syndrome (47%).
Danish: Den mest almindelige ikke-hæmatologiske bivirkning af grad 3 og 4 var cytokinfrigivelsessyndrom (47 %).