FrancophonIA/ELRC3.0 huggingface dataset:
English: Peripheral neuropathy includes paraesthesia, peripheral sensory neuropathy, neuropathy peripheral, hyperaesthesia and hypoaesthesia.
Danish: Perifær neuropati omfatter paræstesi, perifær sensorisk neuropati, perifær neuropati, hyperæstesi og hypæstesi.
English: Do not use this medicine after the expiry date which is stated on the infusion bag label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på infusionsposens etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There is currently no experience with manufacturing Kymriah for patients testing positive for HBV, HCV and HIV.
Danish: Der er på nuværende tidspunkt ingen erfaring med produktion af Kymriah til patienter som er testet positive for HBV, HCV og HIV.
English: The majority of neurological events occurred within 8 weeks following Kymriah infusion and were transient.
Danish: Størstedelen af de neurologiske hændelser forekom inden for 8 uger efter infusion af Kymriah og var forbigående.
English: Epistaxis Lung infiltration
Danish: Epistaxis Lungeinfiltration
English: OS was defined as time from date of Kymriah infusion to the date of death due to any cause for infused patients and from time of date of enrolment to the date of death due to any cause for enrolled patients.
Danish: OS blev defineret som tiden fra datoen for infusion af Kymriah til datoen for dødsfald uanset årsag for infunderede patienter, og fra tiden fra datoen for inklusion til datoen for dødsfald uanset årsag for inkluderede patienter.
English: Haemoglobin decreased* Lymphocyte count decreased* White blood cell count decreased* Neutrophil count decreased* Platelet count decreased* Aspartate aminotransferase increased Alanine aminotransferase increased Blood bilirubin increased International normalised ratio increased
Danish: Nedsat hæmoglobin* Nedsat antal lymfocytter* Nedsat antal hvide blodlegemer* Nedsat neutrofiltal* Nedsat trombocyttal* Forhøjet niveau af aspartataminotransferase Forhøjet niveau af alaninaminotransferase Forhøjet niveau af blodbilirubin Øget international normaliseret ratio Vægttab
English: Two deaths occurred within 30 days of Kymriah infusion: one patient died with cytokine release syndrome and progressive leukaemia and the second patient had resolving cytokine release syndrome with abdominal compartment syndrome, coagulopathy and renal failure when death occurred due to an intracranial haemorrhage.
Danish: Der forekom to dødsfald inden for 30 dage efter infusion af Kymriah; en patient døde med cytokinfrigivelsessyndrom og progressiv leukæmi, og den anden patient havde cytokinfrigivelsessyndrom i bedring med abdominalt kompartmentsyndrom, koagulopati og nyresvigt, da døden indtraf som følge af en intrakraniel blødning.
English: The overall incidence (all grades) was 54% (unspecified 44%, bacterial 10%, fungal 10% and viral 8%) (see section 4.4).
Danish: Den samlede incidens (alle grader) var 54 % (uspecificeret 44 %, bakteriel 10 %, fungal 10 % og viral 8 %) (se pkt.
English: If you have lymphoma, this might include unexplained fever, feeling weak, night sweats, sudden weight loss.
Danish: Hvis du har lymfom, kan det betyde uforklarlig feber, svaghed, nattesved, pludseligt vægttab.
English: Giving blood to make Kymriah Kymriah is made from your own white blood cells.
Danish: Blodgivning til fremstilling af Kymriah Kymriah fremstilles af dine egne hvide blodlegemer.
English: Febrile neutropenia and infections
Danish: Febril neutropeni og infektioner
English: 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 Kymriah.
Danish: Behandlingen bør initieres under anvisning og opsyn af sundhedspersonale, som har erfaring med behandling af hæmatologiske maligniteter og er trænet i administration og håndtering af patienter, der er blevet behandlet med Kymriah.
English: • Swollen ankles, limbs and face
Danish: • Hævede ankler, lemmer og ansigt
English: Before you are given Kymriah your doctor will:
Danish: Før du får behandling med Kymriah, vil lægen:
English: Dyspnoea includes dyspnoea, dyspnoea exertional, respiratory distress and respiratory failure.
Danish: Dyspnø omfatter dyspnø, funktionsdyspnø, åndedrætsbesvær og respirationssvigt.
English: Following infusion of Kymriah into paediatric and young adult r/r B-cell ALL and r/r DLBCL patients, Kymriah typically exhibited an initial rapid expansion followed by a slower bi-exponential decline.
Danish: Efter infusion af Kymriah hos pædiatriske og unge voksne r/r B-celle ALL- og r/r DLBCL-patienter udviste Kymriah typisk en hurtig initial ekspansion efterfulgt af et langsommere bieksponentielt fald.
English: Immunoglobulin levels should be monitored after treatment with Kymriah.
Danish: Immunglobulinniveauerne skal monitoreres efter behandling med Kymriah.
English: Grade 3 and 4 adverse reactions were reported in 88% of patients.
Danish: Bivirkninger af grad 3 og 4 blev rapporteret hos 88 % af patienterne.
English: Dispose of as per local biosafety guideline.
Danish: Skal bortskaffes i henhold til lokal retningslinje vedrørende biosikkerhed.
English: Adverse drug reaction (MedDRA system organ class)
Danish: Bivirkning (MedDRAsystemorganklasse)
English: Table 8 Cellular kinetic parameters of tisagenlecleucel in r/r DLBCL patients by clinical response at month 3
Danish: Tabel 8 Cellekinetiske parametre for tisagenlecleucel hos r/r DLBCL-patienter efter klinisk respons ved måned 3
English: Reasons for discontinuation prior to Kymriah infusion included death (n=16; 10%), physician decision/primary disease progression (n=16; 10%), patient decision (n=3; 2%) or adverse events (n=2; 1%) while awaiting Kymriah manufacturing in the clinical study.
Danish: Årsager til udtrædelse før infusion af Kymriah omfattede dødsfald (n=16; 10 %), lægens beslutning/progression af den primære sygdom (n=16; 10 %), patientens beslutning (n=3; 2 %) eller bivirkninger (n=2; 1 %), mens man ventede på fremstilling af Kymriah i det kliniske studie.
English: Store and transport below -120°C, e.g. in a container for cryogenic storage (Dewar) in the vapour phase of liquid nitrogen.
Danish: Opbevares og transporteres ved temperaturer under -120 °C, fx i en beholder til kryogen opbevaring (Dewar) i dampfasen af flydende nitrogen.
English: cells dispersion for infusion tisagenlecleucel (CAR+ viable T cells)
Danish: celler infusionsvæske, dispersion tisagenlecleucel (CAR+ levende T-celler)
English: Risk factors for severe cytokine release syndrome in paediatric and young adult B-cell ALL patients are: high pre-infusion tumour burden, uncontrolled or accelerating tumour burden following lymphodepleting chemotherapy, active infection and early onset of fever or cytokine release syndrome following Kymriah infusion.
Danish: Risikofaktorer for svær cytokinfrigivelsessyndrom i pædiatriske og unge voksne B-celle ALL patienter er: høj præ-infusions tumorbyrde, ukontrolleret eller accelererende tumorbyrde efter lymfodepleterende kemoterapi, aktiv infektion eller tidlig fremkomst af feber eller cytokinfrigivelsessyndrom efter Kymriah infusion.
English: The infusion bag should be placed inside a second, sterile bag during thawing to protect ports from contamination and avoid spills in the unlikely event of the bag leaking.
Danish: Infusionsposen skal placeres inden i en anden steril pose under optøning for at beskytte portene fra kontaminering, og for at undgå spild, i det usandsynlige tilfælde at posen lækker.
English: Kymriah was given as a single-dose (0.6-6.0 x 108 CAR-positive viable T cells) intravenous infusion in a qualified Kymriah treatment centre in an inpatient and outpatient setting.
Danish: Kymriah blev givet som en enkeltdosis (0,6-6,0 x 108 CAR-positive levende T celler) via intravenøs infusion i et kvalificeret Kymriah behandlingscenter både som ambulant behandling og under indlæggelse.
English: There is no experience with manufacturing Kymriah for patients with a positive test for active HBV, HCV or HIV.
Danish: Der er ingen erfaring med fremstilling af Kymriah til patienter, som har en positiv test for aktiv HBV, HCV eller HIV.
English: All patients had leukapheresis products collected and cryopreserved prior to or during study entry.
Danish: Alle patienter fik leukaferese-produkter indsamlet og kryopræserveret forud for eller under indtrædelsen i studiet.
English: DOR was defined as time since onset of CR or CRi to relapse or death due to underlying indication, whichever is earlier (N=61).
Danish: DOR var defineret som tiden fra indtrædelse af CR eller CRi til recidiv eller dødsfald som følge af underliggende indikation, alt efter hvad der forekommer først (N=61).
English: Enrolled patients N=92
Danish: Inkluderede patienter N=92
English: Kymriah will always be given to you by a doctor.
Danish: Det vil altid være en læge, der giver dig Kymriah.
English: Kymriah contains human blood cells.
Danish: Kymriah indeholder humane blodceller.
English: The CAR is comprised of a murine single chain antibody fragment which recognises CD19 and is fused to intracellular signalling domains from 4-1BB (CD137) and CD3 zeta.
Danish: Den kimære antigenreceptor (CAR) består af et murint enkeltkædeantistof-fragment, der genkender CD19 og er fusioneret med intracellulære signaleringsdomæner fra 4-1BB (CD137) og CD3 zeta.
English: The majority of patients tested positive for pre-dose anti-mCAR19 antibodies in paediatric and young adult ALL (B2202 and B2205J, 84.6%) and adult DLBCL (C2201, 91.4%).
Danish: Størstedelen af patienterne blev testet positive for anti-mCAR19-antistoffer før dosering hos pædiatriske og unge voksne patienter med ALL (B2202 og B2205J, 84,6 %) og voksne DLBCL-patienter (C2201, 91,4 %).
English: Pre-treatment conditioning (lymphodepleting chemotherapy)
Danish: Konditionering før behandling (lymfodepleterende kemoterapi)
English: Neurological adverse reactions The majority of neurological events occurred within 8 weeks following infusion and were transient.
Danish: Neurologiske bivirkninger Størstedelen af de neurologiske hændelser forekom inden for 8 uger efter infusion og var forbigående.
English: Efficacy was established through the primary endpoint of overall remission rate (ORR) within 3 months post infusion, as determined by Independent Review Committee (IRC) assessment, duration of remission (DOR) and the proportion of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) with minimal residual disease (MRD) <0.01% by flow cytometry (MRD-negative).
Danish: Virkningen blev etableret gennem det primære endepunkt samlet remissionsrate (ORR) inden for 3 måneder efter infusion, vurderet af en uafhængig komite til gennemgang af data (IRC), varighed af remission (DOR) og andel af patienter, der opnåede komplet remission (CR) eller komplet remission med ufuldstændig normalisering af blodtal (CRi) med minimal residualsygdom (MRD) på <0,01 % bestemt ved flowcytometri (MRD-negativ).
English: Gender is not a significant characteristic influencing tisagenlecleucel expansion in B-cell ALL and DLBCL patients.
Danish: Køn er ikke et signifikant karakteristikum, der influerer på ekspansion af tisagenlecleucel hos B-celle ALL- og DLBCL-patienter.
English: Treatment-induced anti-mCAR19 antibodies were shown in 34.6% of paediatric and young adult ALL and 5% of adult DLBCL patients.
Danish: Behandlingsinduceret anti-mCAR19-antistoffer blev påvist hos 34,6 % af pædiatriske og unge voksne patienter med ALL og hos 5 % af voksne DLBCL-patienter.
English: Final CSR: August 2023
Danish: Endelig CSR: August
English: Inspection and thawing of the infusion bag(s)
Danish: Inspektion of optøning af infusionsposen('erne)
English: Before you are given Kymriah you should tell your doctor if:
Danish: Før du får behandling med Kymriah, skal du fortælle det til lægen, hvis:
English: Ischaemic cerebral infarction
Danish: Iskæmisk cerebral infarkt
English: The infusion start time should be confirmed in advance and adjusted for thaw so that Kymriah is available for infusion when the recipient is ready.
Danish: Starttidspunktet for infusionen skal bekræftes på forhånd, og justeres for optøning, så Kymriah er tilgængeligt til infusion, når recipienten er klar.
English: Severe febrile neutropenia (Grade 3 or 4) was observed in 36% of paediatric and young adult B-cell ALL patients and 15% of DLBCL patients.
Danish: Der blev observeret svær febril neutropeni (grad 3 eller 4) hos 36 % af de pædiatriske og unge voksne B-celle ALL-patienter og hos 15 % af DLBCL-patienterne.
English: Dosage in paediatric and young adult B-cell ALL patients - For patients 50 kg and below: 0.2 to 5 x 106 CAR-positive viable T cells/kg body weight.
Danish: Dosering hos pædiatriske og unge voksne patienter med B-celle ALL - Til patienter, der vejer 50 kg og derunder: 0,2 til 5 x 106 CAR-positive levende T-celler/kg legemsvægt.
English: OS was defined as time from date of Kymriah infusion to the date of death due to any cause on FAS (N=111) and time from date of enrolment to the date of death due to any cause for enrolled patients (N=165).
Danish: OS var defineret som tiden fra datoen for infusion af Kymriah til datoen for dødsfald uanset årsag på FAS (N=111) og tiden fra datoen for inklusion til datoen for dødsfald uanset årsag for inkluderede patienter (N=165).
English: Leukapheresis for Kymriah manufacturing should be performed at least 12 weeks after allogeneic SCT.
Danish: Leukaferese til Kymriah produktion skal udføres mindst 12 uger efter allogen SCT. HBV reaktivering
English: To minimise risk of TLS, patients with elevated uric acid or high tumour burden should receive allopurinol, or an alternative prophylaxis, prior to Kymriah infusion.
Danish: For at minimere risikoen for TLS bør patienter med forhøjet niveau af urinsyre eller høj tumorbyrde få allopurinol, eller anden profylakse, forud for infusion af Kymriah.
English: In the ongoing clinical study in DLBCL (N=111), cytokine release syndrome was reported in 58% of patients, (22% with Grade 3 or 4).
Danish: I det igangværende kliniske studie hos DLBCL-patienter (N=111) blev der rapporteret cytokinfrigivelsessyndrom hos 58 % af patienterne (22 % med grad 3 eller 4).
English: Neurological events can be concurrent with cytokine release syndrome, following resolution of cytokine release syndrome or in the absence of cytokine release syndrome.
Danish: Neurologiske hændelser kan indtræde sideløbende med cytokinfrigivelsessyndrom, efter resolution af cytokinfrigivelsessyndrom eller ved fravær af cytokinfrigivelsessyndrom.
English: Ethylene vinyl acetate (EVA) infusion bag with polyvinyl chloride (PVC) tubing and a luer spike interconnector closed by a luer-lock cap containing either 10-30 mL (50 mL bags) or 30-50 mL (250 mL bags) cell dispersion.
Danish: Ethylenvinylacetat (EVA)-infusionsposer med polyvinylchlorid (PVC)-slanger og en luer-spidssammenkobler lukket med en luer-lock-hætte, der indeholder enten 10-30 ml (50 ml pose) eller 30-50 ml (250 ml pose) celledispersion.
English: Grade 3 and 4 adverse reactions were more often observed within the initial 8 weeks post-infusion (85%) compared to after 8 weeks post-infusion (49%).
Danish: Bivirkninger af grad 3 og 4 blev observeret oftere inden for de første 8 uger efter infusion (85 %) sammenlignet med efter 8 uger efter infusion (49 %).
English: Low-grade fever, fatigue, anorexia
Danish: Prodromalsyndrom: Lav feber, træthed, anoreksi
English: Other secondary endpoint
Danish: Andet sekundært endepunkt
English: Monitoring after infusion - Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities.
Danish: Monitorering efter infusion - Patienter bør monitoreres dagligt for tegn og symptomer på potentiel cytokinfrigivelsessyndrom, neurologiske hændelser og andre toksiciteter i de første 10 dage efter infusion.
English: All contents of the infusion bags should be infused.
Danish: Alt indhold i infusionsposen bør infunderes.
English: Management of cytokine release syndrome associated with Kymriah Cytokine release syndrome is managed solely based on clinical presentation and according to the cytokine release syndrome management algorithm provided in Table 1.
Danish: Håndtering af cytokinfrigivelsessyndrom forbundet med Kymriah Cytokinfrigivelsessyndrom håndteres udelukkende på baggrund af klinisk præsentation og i henhold til algoritmen til håndtering af cytokinfrigivelsessyndrom, som er vist i tabel 1.
English: Cardiac failure includes cardiac failure, left ventricular dysfunction, cardiac failure congestive and right ventricular dysfunction.
Danish: Hjertesvigt omfatter hjertesvigt, dysfunktion af venstre ventrikel, kongestivt hjertesvigt og dysfunktion af højre ventrikel.
English: Pruritus Erythema Night sweats Petechiae Hyperhidrosis
Danish: Pruritus Erytem Nattesved Petekkier Hyperhidrose
English: Patients with T-cell rich/histiocyte-rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), EBV-positive DLBCL of the elderly, Richter's transformation, and Burkitt lymphoma were not enrolled in study C2201.
Danish: Patienter med T-celle-rig/histiocytrig diffust storcellet B-celle lymfom (THRBCL), primært kutant storcellet B-celle lymfom, primært mediastinalt B-celle lymfom (PMBCL), EBV-positiv DLBCL hos ældre patienter, Richter's transformation og Burkitt lymfom blev ikke inkluderet i studie C2201.
English: Bacterial infections Fungal infections
Danish: Bakterieinfektioner Svampeinfektioner
English: Table 7 Cellular kinetic parameters of tisagenlecleucel in paediatric and young adult r/r B-cell ALL (Studies B2202 and B2205J)
Danish: Tabel 7 Cellekinetiske parametre for tisagenlecleucel hos pædiatriske og unge voksne r/r B-celle ALL-patienter (studie B2202 og B2205J)
English: Kymriah is intended for autologous use only (see section 4.4).
Danish: Kymriah er udelukkende beregnet til autolog anvendelse (se pkt.
English: Kymriah is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Kymriah bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: • Flu-like illness
Danish: • Influenza-lignende sygdom
English: Kymriah should not be used in children and adolescents below 18 years of age to treat DLBCL.
Danish: Kymriah bør ikke anvendes til børn og unge under 18 år til behandling af DLBCL, da Kymriah ikke er blevet undersøgt hos denne aldersgruppe.
English: There is limited experience with Kymriah in patients exposed to prior CD19-directed therapy.
Danish: Der er begrænset erfaring med Kymriah hos patienter, der tidligere har været eksponeret for behandling rettet mod CD19.
English: Upon binding to CD19-expressing cells, the CAR transmits a signal promoting T-cell expansion and persistence of tisagenlecleucel.
Danish: Ved binding til CD19-udtrykkende celler transmitterer den kimære antigenreceptor (CAR) et signal der faciliterer T-celle-ekspansion og persistens af tisagenlecleucel.
English: Patients with active, uncontrolled infection should not start Kymriah treatment until the infection is resolved.
Danish: Behandling med Kymriah bør ikke initieres hos patienter med aktiv ukontrolleret infektion, før infektionen er forsvundet.
English: • Shortness of breath, laboured breathing, rapid breathing, fluid in the lungs
Danish: • Stakåndethed, åndedrætsbesvær, hurtig vejrtrækning, væske i lungerne
English: Cellular kinetics in adult DLBCL patients
Danish: Cellekinetik hos voksne patienter med DLBCL
English: There is limited evidence that race/ethnicity impact the expansion of Kymriah in paediatric and young adult ALL and DLBCL patients.
Danish: Der er begrænset dokumentation vedrørende indvirkning af race/etnicitet på ekspansionen af Kymriah hos pædiatriske og unge voksne ALL-patienter og DLBCL-patienter.
English: Women who are breast-feeding should be advised of the potential risk to the breast-fed infant.
Danish: Kvinder der ammer skal informeres om den potentielle risiko for det ammende spædbarn.
English: The safety and efficacy of Kymriah treatment in paediatric and young adult patients with relapsed or refractory (r/r) B-cell ALL were evaluated in one pivotal (B2202) and two supportive (B2205J and B2101J) open-label, single-arm studies (160 patients in total, up to 25 years of age).
Danish: Sikkerheden og virkningen af behandling med Kymriah hos pædiatriske og unge voksne patienter med recidiverende eller refraktær (r/r) B-celle ALL blev vurderet i et pivotalt (B2202) og to supporterende (B2205J og B2101J) ublindede enkeltarm studier (160 patienter i alt, op til en alder på 25 år).
English: • Before you are given Kymriah, your doctor may give you a type of treatment called lymphodepleting chemotherapy for a few days to prepare your body.
Danish: • For at forberede din krop inden du får Kymriah, kan lægen i nogle få dage give dig en form for behandling, der kaldes lymfodepleterende kemoterapi.
English: In the ongoing clinical studies in paediatric and young adult B-cell ALL (N=75), cytokine release syndrome was reported in 77% of patients (47% with Grade 3 or 4).
Danish: I de igangværende kliniske studier hos pædiatriske og unge voksne B-celle ALL-patienter (N=75) blev der rapporteret cytokinfrigivelsessyndrom hos 77 % af patienterne (47 % med grad 3 eller 4).
English: • high fever and chills.
Danish: • høj feber og kuldegysninger.
English: Key baseline information for enrolled and infused patients is presented in Table 5.
Danish: Vigtige baseline oplysninger for inkluderede og infunderede patienter er vist i tabel 5.
English: Lymphodepleting chemotherapy may be omitted if a patient's white blood cell (WBC) count is ≤1,000 cells/µL within 1 week prior to Kymriah infusion.
Danish: Lymfodepleterende kemoterapi kan udelades, hvis antallet af hvide blodlegemer (WBC) hos patienten er ≤1.000 celler/µl inden for 1 uge før infusion af Kymriah.
English: • Abnormal blood test results (high level of: phosphorus, magnesium, an enzyme called alkaline phosphatase to help detect liver disease, fibrin d-dimer, serum ferritin; low level of: sodium)
Danish: • Unormale blodprøveresultater (højt niveau af: fosfor, magnesium, et enzym der kaldes basisk fosfatase der hjælper med at opdage leversygdomme, fibrin D-dimer, serumferritin; lavt niveau af: natrium)
English: Kymriah can cause problems such as altered or decreased consciousness, confusion and seizures (fits) in the 8 weeks following infusion.
Danish: Kymriah kan forårsage problemer, fx ændret eller nedsat bevidsthedsniveau, forvirring og krampeanfald (kramper) i 8 uger efter infusionen.
English: The overall incidence (all grades) was 65% (unspecified 49%, viral 32%, bacterial 24% and fungal 15%) (see section 4.4).
Danish: Den samlede incidens (alle grader) var 65 % (uspecificeret 49 %, viral 32 %, bakteriel 24 % og fungal 15 %) (se pkt.
English: Cytokine release syndrome Hypogammaglobulinaemiab)
Danish: Cytokinfrigivelsessyndrom Hypogammaglobulinæmib)
English: In DLBCL patients, manifestations of encephalopathy and/or delirium occurred in 21% of patients (12% were Grade 3 or 4) within 8 weeks after Kymriah infusion.
Danish: Hos DLBCL-patienter opstod der tegn på encefalopati og/eller delirium hos 21 % af patienterne (12 % var af grad 3 eller 4) inden for 8 uger efter infusion af Kymriah.
English: The bag should be removed immediately from the thawing device and kept at room temperature (20°C-25°C) until infusion.
Danish: Posen skal straks fjernes fra optøsningsudstyret og opbevares ved stuetemperatur (20 °C-25 °C) indtil infusion.
English: MRD (minimal residual disease) negative was defined as MRD by flow cytometry <0.01%.
Danish: MRD (minimal residualsygdom)-negativ var defineret som MRD bestemt ved flowcytometri på
English: This medicinal product contains 2.43 mg sodium per mL and 24.3 to 121.5 mg sodium per dose.
Danish: Dette lægemiddel indeholder 2,43 mg natrium pr. ml og 24,3 til 121,5 mg natrium pr dosis.