FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections - pathogen unspecified Viral infections
Danish: Infektioner - patogen uspecificeret Virusinfektioner
English: In vivo studies in immunocompromised mice did not show signs of abnormal cell growth or signs of clonal cell expansion for up to 7 months, which represents the longest meaningful observation period for immunocompromised mouse models.
Danish: In vivo-studier hos immunkompromitterede mus viste ingen tegn på abnorm cellevækst eller tegn på klonal celleekspansion i op til 7 måneder, hvilket er den længste relevante observationsperiode for immunkompromitterede musemodeller.
English: • If you become pregnant or think you may be pregnant after treatment with Kymriah, talk your doctor immediately.
Danish: • Hvis du bliver gravid eller tror, at du er gravid efter behandling med Kymriah, skal du kontakte lægen med det samme.
English: • You have any lung, heart or blood pressure (low or raised) problems.
Danish: • Du har lunge-, hjerte- eller blodtryksproblemer (lavt eller højt blodtryk).
English: Clinical assessment prior to infusion
Danish: Klinisk vurdering inden infusion
English: Contraindications of the lymphodepleting chemotherapy must be considered.
Danish: Kontraindikationer for den lymfodepleterende kemoterapi skal overvejes.
English: Patients treated with Kymriah should not donate blood, organs, tissues and cells for transplantation.
Danish: Patienter, der er blevet behandlet med Kymriah, bør ikke donere blod, organer, væv og celler til transplantation.
English: Abdominal compartment syndrome
Danish: Abdominalt kompartmentsyndrom
English: Health-related quality of life (HRQoL) was evaluated by PedsQL™ and EQ-5D questionnaires completed by patients aged 8 years and above (n=58).
Danish: Helbredsrelateret livskvalitet (HRQoL) blev evalueret med spørgeskemaundersøgelserne PedsQL™ og EQ-5D, som blev gennemført af patienter i alderen 8 år og derover (n=58).
English: • Confusion
Danish: • Forvirring
English: • Do not donate blood, organs, tissues or cells for transplants.
Danish: • Du må ikke donere blod, organer, væv eller celler til transplantationer.
English: - Significant clinical worsening of leukaemia burden or lymphoma following lymphodepleting chemotherapy.
Danish: - Signifikant klinisk forværring af leukæmibyrden eller lymfom efter lymfodepleterende kemoterapi.
English: • in the 6 weeks before you are given the short course of chemotherapy (called lymphodepleting chemotherapy) to prepare your body for the Kymriah cells.
Danish: • inden for 6 uger før du får det korte forløb med kemoterapi (kaldet lymfodepleterende kemoterapi), for at forberede din krop til Kymriah-cellerne.
English: Kymriah has major influence on the ability to drive and use machines.
Danish: Kymriah påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: ORR is the proportion of patients with best overall response (BOR) of CR or PR based on the Lugano response criteria (Cheson 2014); non-infused patients were assigned BOR=Unknown (i.e. non-responders).
Danish: ORR blev defineret som andelen af patienter med det bedste samlede respons (BOR) af CR eller PR, baseret på Lugano respons-kriterierne (Cheson 2014); ikke-infunderede patienter blev tildelt BOR=ukendt (dvs. ikke-responderende).
English: Each infusion bag is placed into an aluminum cassette, then put in a plastic overwrap bag with absorbent sheets and sealed in a protective envelope (Tyvek).
Danish: Hver infusionspose er placeret i en aluminiumskasette, herefter i en beskyttelsespose af plastic med absorberende materiale og forseglet i en beskyttende kuvert (Tyvek).
English: Intravenous use Do not use leukocyte depleting filter.
Danish: Intravenøs anvendelse Anvend ikke leukocytfilter.
English: • If no clinical improvement within 12 to 18 hours of the first tocilizumab dose, or worsening at any time, administer methylprednisolone 2 mg/kg as an initial dose, then 2 mg/kg per day until vasopressors and high-flow oxygen are no longer needed, then taper.
Danish: • Hvis der ikke er klinisk forbedring inden for 12 til 18 timer efter første dosis af tocilizumab, eller hvis der er forværring på noget tidspunkt, administrer methylprednisolone 2 mg/kg som startdosis, herefter 2 mg/kg per dag indtil vasopressorer og high-flow oxygen ikke længere er nødvendigt, herefter aftrappes.
English: When Kymriah is infused into your blood, the modified T cells will find the cancer cells and destroy them.
Danish: Når Kymriah ved infusionen kommer ind i dit blod, vil de modificerede T-celler finde kræftcellerne og ødelægge dem.
English: DLBCL: The safety and efficacy of Kymriah in children and adolescents below 18 years of age have not yet been established.
Danish: DLBCL: Kymriahs sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Please refer to section 6.6 for details on inspection and thawing of the infusion bag.
Danish: 6.6 for detaljer omkring inspektion og optøning af infusionsposen.
English: Genotoxicity assays and carcinogenicity studies in rodents are not appropriate to assess the risk of insertional mutagenesis for genetically-modified cell therapy products.
Danish: Genotoksicitetsanalyser og karcinogenicitetsstudier hos gnavere er ikke hensigtsmæssige til vurdering af risikoen for insertionsmutagenese for behandlingsprodukter med genetisk modificerede celler.
English: Each of these excipients are known to possibly cause anaphylactic reaction following parenteral administration.
Danish: Begge disse indholdsstoffer kan muligvis forårsage anafylaktiske reaktioner efter parenteral administration.
English: Juvenile toxicity studies were not conducted.
Danish: Der blev ikke udført toksicitetsstudier hos unge dyr.
English: ** With reported sequelae of secondary cerebral oedema.
Danish: ** Med rapporterede følgetilstande af sekundært cerebralt ødem.
English: Patients with a history of active CNS disorder or inadequate renal, hepatic, pulmonary or cardiac function were excluded from the studies.
Danish: Patienter med en historik med aktiv CNS sygdom eller utilstrækkelig nyre-, lever-, lunge- eller hjertefunktion var ekskluderet fra studierne.
English: Store in the original protective envelope (Tyvek) containing the cassette protecting the infusion bag.
Danish: Opbevares i den originale beskyttende kuvert (Tyvek) der indeholder den kasette, der beskytter infusionsposen.
English: • Leakage of fluids from blood vessels into surrounding tissue.
Danish: • Udsivning af væske fra blodårer til omkringliggende væv.
English: Due to the potential for neurological events, including altered mental status or seizures, patients receiving Kymriah are at risk for altered or decreased consciousness or coordination in the 8 weeks following infusion.
Danish: Grundet potentialet for neurologiske hændelser, herunder ændret mental status eller krampeanfald, har patienter, der får Kymriah, risiko for ændret eller nedsat bevidsthedsniveau eller koordination i 8 uger efter infusionen.
English: In vitro expansion studies with CAR-positive T cells (Kymriah) from healthy donors and patients showed no evidence for transformation and/or immortalisation of T cells.
Danish: In vitro-ekspansionsstudier med CAR-positive T-celler (Kymriah) fra raske donorer og patienter viste ingen tegn på transformation og/eller immortalisation af T-celler.
English: The medicine can be used in adults (18 years of age or older) with this cancer.
Danish: Lægemidlet kan anvendes til voksne (18 år og derover) med denne kræftform.
English: Patients should be monitored for signs and symptoms of infection and treated appropriately.
Danish: Patienterne skal monitoreres for tegn og symptomer på infektion og have relevant behandling.
English: ORR was consistent across subgroups.
Danish: OOR var konsistent på tværs af undergrupper.
English: Due to limited short spans of identical genetic information between the lentiviral vector used to create Kymriah and HIV, some commercial HIV nucleic acid tests (NAT) may give a false positive result.
Danish: Grundet begrænsede korte sekvenser med identisk genetisk information mellem HIV og den lentivirale vektor, der anvendes til at skabe Kymriah, kan nogle kommercielle HIV-nukleinsyretest (NAT) give et falsk positivt resultat.
English: To minimise potential acute infusion reactions, it is recommended that patients be pre-medicated with paracetamol and diphenhydramine or another H1 antihistamine within approximately 30 to 60 minutes prior to Kymriah infusion.
Danish: For at minimere potentielle akutte infusionsreaktioner, anbefales det, at patienterne præmedicineres med paracetamol og diphenhydramin, eller en anden H1-antihistamin, inden for ca. 30 til 60 minutter før infusion af Kymriah.
English: Final report: December 2023
Danish: Endelig rapport: December 2023
English: In Study C2201 there were 88% Caucasian, 5% Asian, 4% Black or African American patients, and 3 patients (3%) of unknown race.
Danish: I studie C2201 var der 88 % kaukasiere, 5 % asiater, 4 % sorte eller afroamerikanere og 3 patienter (3 %) af ukendt race.
English: The safety of immunisation with live viral vaccines during or following Kymriah treatment has not been studied.
Danish: Sikkerheden af immunisering med levende virus-vacciner under eller efter behandling med Kymriah er ikke blevet undersøgt.
English: Patients not previously exposed to dextran and DMSO should be observed closely during the first minutes of the infusion period.
Danish: Patienter, som ikke før har været udsat for dextran og DMSO, bør observeres tæt under de første minutter af infusionsperioden.
English: Local biosafety guidelines should be followed for disposal.
Danish: Lokale retningslinjer for biosikkerhed skal følges for bortskaffelse.
English: Cytokine release syndrome requiring mild intervention - one or more of the following: High fever Hypoxia Mild hypotension
Danish: Cytokinfrigivelsessyndrom der kræver mild intervention - en eller flere af følgende: Høj feber Hypoxi Mild hypotension
English: Prior transplantation
Danish: Tidligere transplantation
English: This can interfere with the workings of various body organs, especially the kidneys, heart and nervous system (tumour lysis syndrome).
Danish: Dette kan påvirke funktionen af forskellige organer i kroppen, særligt nyrer, hjerte og nervesystemet (tumorlysesyndrom).
English: Overall response rate (ORR) (CR+PR)1, n (%) 95% CI
Danish: Samlet responsrate (ORR) (CR+PR)1, n (%) 95 % CI
English: If you have not been previously exposed to dextran or DMSO you should be observed closely during the first minutes of the infusion period.
Danish: Hvis du ikke tidligere har fået dextran eller DMSO, skal du observeres tæt under de første minutter af infusionsperioden.
English: After you are given Kymriah
Danish: Efter at du har fået Kymriah
English: Prior to Kymriah infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the infusion bag(s).
Danish: Før infusion af Kymriah skal det bekræftes, at patientens identitet stemmer overens med de essentielle unikke patientoplysninger på infusionsposen('erne).
English: The concentration of CAR-positive viable T cells is dependent on indication and patient body weight (for B-cell acute lymphoblastic leukaemia [ALL]).
Danish: Koncentrationen af CAR-positive levende T-celler er afhængig af indikationen og patientens kropsvægt (for B-celle akut lymfoblastær leukemi [ALL]).
English: - Patient weight less than 30 kg: 12 mg/kg intravenously over 1 hour - Patient weight ≥30 kg: 8 mg/kg intravenously over 1 hour (maximum dose 800 mg)
Danish: - Patienter der vejer mindre end 30 kg: 12 mg/kg intravenøst over 1 time - Patienter der vejer ≥30 kg: 8 mg/kg intravenøst over 1 time (maximal dosis 800 mg)
English: Prior treatment with anti-CD19 therapy
Danish: Tidligere behandling med anti-CD19 terapi
English: Signs and symptoms of TLS should be monitored and events managed according to standard guidelines.
Danish: Tegn og symptomer på TLS skal monitoreres og hændelser håndteres i henhold til standardretningslinjer.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge lægen til råds, før du får behandling med dette lægemiddel.
English: 103/111 patients (93%) received lymphodepleting chemotherapy prior to Kymriah infusion.
Danish: 103/111 patienter (93 %) fik lymfodepleterende kemoterapi før infusion af Kymriah.
English: The CD3 zeta component is critical for initiating T-cell activation and antitumour activity, while 4-1BB enhances the expansion and persistence of tisagenlecleucel.
Danish: CD3 zeta-komponenten er afgørende for initiering af T-celle-aktivering og antitumoraktivitet, mens 4-1BB forstærker ekspansionen og persistensen af tisagenlecleucel.
English: It is supplied as an infusion bag containing a cloudy to clear, colourless to slightly yellow dispersion of cells.
Danish: Den bliver leveret som en infusionspose, der indeholder en uklar til klar, farveløs til svagt gul celledispersion.
English: Pre-existing and treatment-induced antibodies were not associated with an impact on clinical response nor did they have an impact on the expansion and persistence of tisagenlecleucel.
Danish: Allerede eksisterende og behandlingsinducerede antistoffer var ikke forbundet med nogen påvirkning af klinisk respons, og de havde heller ingen påvirkning af ekspansionen og persistensen af tisagenlecleucel.
English: Talk to your doctor or nurse before you are given Kymriah if you have a history of:
Danish: Tal med din læge eller sygeplejerske, før du får Kymriah, hvis du tidligere har:
English: Prolonged cytopenias Cytopenias are very common with Kymriah therapy.
Danish: Cytopenier af længere varighed Cytopenier er meget almindelige med Kymriah behandling.
English: In almost all cases, development of cytokine release syndrome occurred between 1 to 10 days (median onset 3 days) after Kymriah infusion.
Danish: I næsten alle tilfælde forekom udviklingen af cytokinfrigivelsessyndrom mellem 1 til 10 dage (mediantid til indtrædelse 3 dage) efter infusion af Kymriah.
English: The patient's identity should be matched with the patient identifiers on the infusion bag.
Danish: Patientens identitet skal stemme overens med patient-identifikatorerne på infusionsposen.
English: The quantitative information regarding CAR-positive viable T cells/mL and total cells in the product is presented in the batch-specific documentation accompanying Kymriah.
Danish: De kvantitative oplysninger vedrørende CAR-positive levende T-celler/ml og det totale antal celler i produktet er anført i den specifikke batchdokumentation, der medfølger Kymriah.
English: A colourless to slightly yellow dispersion.
Danish: En farveløs til svagt gul dispersion.
English: Overall remission rate (ORR)
Danish: Samlet remissionsrate (ORR)
English: If your temperature is high, see your doctor immediately.
Danish: Hvis din temperatur er forhøjet, skal du straks tale med din læge.
English: Kymriah, also known as tisagenlecleucel, is made from some of your own white blood cells called T cells.
Danish: Kymriah, der også kaldes tisagenlecleucel, er fremstillet af nogle af dine egne hvide blodlegemer, der kaldes T-celler.
English: CR or CRi with MRD negative bone marrow5,6, n (%) 95% CI
Danish: CR eller CRi med MRD-negativ knoglemarv5,6, n (%) 95 % CI
English: Efficacy analysis set (EAS) includes patients infused with Kymriah at least 3 months prior to data cutoff date.
Danish: Effektanalysedatasæt (EAS) inkluderer patienter infunderet med Kymriah i mindst 3 måneder før dataafskæringsdatoen.
English: If more than one infusion bag has been received for the treatment dose, the next bag should only be thawed after the contents of the preceding bag have been infused.
Danish: Hvis der er modtaget mere end én infusionspose som behandlingsdosis, bør den næste pose først optøs, efter at indholdet af den foregående pose er blevet infunderet.
English: DOR was defined as time from achievement of CR or PR, whichever occurs first, to relapse or death due to DLBCL.
Danish: DOR var defineret som tiden fra opnåelse af CR eller PR, alt efter hvad der forekommer først, til recidiv eller dødsfald som følge DLBCL.
English: Pregnant women who have received Kymriah may have hypogammaglobulinaemia.
Danish: Gravide kvinder, som har fået Kymriah, kan få hypogammaglobulinæmi.
English: In patients with low immunoglobulin levels pre-emptive measures such as infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be taken according to age and standard guidelines.
Danish: Hos patienter med lavt niveau af immunoglobuliner skal der ydes forebyggende tiltag, såsom forebyggelse af infektion, antibiotika profylakse og immunglobulinsubstitution i henhold til alder og standardretningslinjer.
English: Pregnant women should be advised on the potential risks to the foetus.
Danish: Gravide kvinder skal informeres om de potentielle risici for fosteret.
English: Non-responding patients (SD/PD/Unknown) N=58
Danish: Ikke-responderende patienter (SD/PD/ukendt) N=58
English: The timing of thaw of Kymriah and of infusion should be coordinated.
Danish: Tidspunktet for optøning af Kymriah og for infusion skal koordineres.
English: • B-cell acute lymphoblastic leukaemia (B-cell ALL) - a form of cancer that affects some other types of white blood cells.
Danish: • B-celle akut lymfoblastær leukæmi (B-celle ALL) - en form for kræft, der rammer visse andre typer hvide blodlegemer.
English: The elimination profile of Kymriah includes a bi-exponential decline in peripheral blood and bone marrow.
Danish: Kymriahs elimineringsprofil omfatter et bieksponentielt fald i perifert blod og knoglemarv.
English: Kymriah is recommended to be infused 2 to 14 days after completion of the lymphodepleting chemotherapy.
Danish: Det anbefales at infundere Kymriah 2 til 14 dage efter gennemførelse af den lymfodepleterende kemoterapi.
English: B-cell ALL: No formal studies have been performed in paediatric patients below 3 years of age.
Danish: B-celle ALL: Der er ikke udført kontrollerede studier med pædiatriske patienter under 3 år.
English: The maximal expansion (Cmax) was approximately 2-fold higher in CR/CRi patients (n=79) compared with non-responding (NR) patients (n=10) as measured by qPCR.
Danish: Den maksimale ekspansion (Cmax) var cirka 2 gange højere hos CR-/CRi-patienter (n=79) sammenlignet med ikke-responderende (NR) patienter (n=10) målt ved qPCR.
English: Infections and infestations presented reflect high-level group terms.
Danish: Infektioner og parasitære sygdomme er præsenteret som højniveaugruppetermer.
English: This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially “potassium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (39 mg) kalium pr. dosis, dvs. den er i det væsentlige kaliumfri.
English: • Extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red blood cells.
Danish: • Haft udtalt træthed, svaghed og stakåndethed, som kan være symptomer på mangel af røde blodlegemer.
English: Among patients responding (n=48), the mean (SD) change from baseline in the PedsQL total score was 13.5 (13.5) at month 3, 16.9 (17.6) at month 6 and 27.2 (21.7) at month 12, and the mean (SD) change from baseline in the EQ-5D VAS score was 16.5 (17.5) at month 3, 15.9 (20.1) at month 6 and 24.7 (18.6) at month 12, indicating overall clinically meaningful improvement in HRQoL following Kymriah infusion.
Danish: Blandt de patienter, der svarede (n=48), var den gennemsnitlige ændring (SD) fra baseline i den samlede PedsQL-score 13,5 (13,5) ved måned 3, 16,9 (17,6) ved måned 6 og 27,2 (21,7) ved måned 12, og den gennemsnitlige ændring (SD) fra baseline i EQ-5D VAS-scoren var 16,5 (17,5) ved måned 3, 15,9 (20,1) ved måned 6 og 24,7 (18,6) ved måned 12, hvilket indikerede en samlet klinisk relevant forbedring i HRQoL efter infusion af Kymriah.
English: • if you are allergic to any of the ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for et eller flere af indholdsstofferne i Kymriah (angivet i punkt 6).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kymriah in one or more subsets of the paediatric population in the following conditions: a) treatment of B-cell lymphoblastic lymphoma, and b) treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Kymriah i en eller flere undergrupper af den pædiatriske population ved følgende tilstande: a) behandling af B-celle lymfoblastær leukæmi, og b) behandling af modne B-celle neoplasmer (se pkt.
English: In case of neurological events, patients should be diagnostically worked up and managed depending on the underlying pathophysiology and in accordance with local standard of care.
Danish: I tilfælde af neurologiske hændelser bør patienter have foretaget diagnostiske undersøgelser og behandles afhængigt af den underliggende patofysiologi og i overensstemmelse med lokal standardbehandling.
English: These may be symptoms of a serious condition called cytokine release syndrome.
Danish: Disse kan være symptomer på en alvorlig tilstand, der hedder cytokinfrigivelsessyndrom.
English: Kymriah is for intravenous use only.
Danish: Kymriah er udelukkende til intravenøs brug.
English: Prior to the launch of KYMRIAH in each Member State, the MAH must agree about the content and format of the educational materials with the National Competent Authority.
Danish: Forud for lanceringen af Kymriah i hvert medlemsland, skal indehaveren af markedsføringstilladelsen blive enige med den nationale myndighed om indholdet og formatet af uddannelsesmaterialet.
English: The availability of Kymriah must be confirmed prior to starting the lymphodepleting regimen.
Danish: Tilgængeligheden af Kymriah skal bekræftes før opstart af lymfodepleterende behandlingsregime.
English: The efficacy of Kymriah was evaluated through the primary endpoint of best overall response rate (ORR), which includes complete response (CR) and partial response (PR) as determined by Independent Review Committee (IRC) assessment as well as secondary endpoints including duration of response (Table 6).
Danish: Virkningen af Kymriah blev evalueret gennem det primære endepunkt bedste samlede responsrate (ORR), som omfatter komplet respons (CR) og partielt respons (PR), vurderet af en uafhængig komite til gennemgang af data (IRC), såvel som sekundære endepunkter, herunder varighed af respons (tabel 6).
English: Non-clinical safety assessment of Kymriah addressed the safety concerns of potential uncontrolled cell growth of transduced T cells in vitro and in vivo as well as dose-related toxicity, biodistribution and persistence.
Danish: Præklinisk sikkerhedsvurdering af Kymriah omhandlede sikkerhedsspørgsmål vedrørende potentiel ukontrolleret cellevækst af transducerede T-celler in vitro og in vivo såvel som dosisrelateret toksicitet, biodistribution og persistens.
English: B-cell ALL: The safety and efficacy of Kymriah in this population have not been established.
Danish: B-celle ALL: Kymriahs sikkerhed og virkning hos denne population er ikke klarlagt.
English: Ensure that a minimum of four doses of tocilizumab and emergency equipment are available prior to infusion and during the recovery period.
Danish: Det skal sikres, at mindst fire doser af tocilizumab og nødudstyr er tilgængeligt forud for infusionen og i restitueringsperioden.
English: Hypogammaglobulinaemia and agammaglobulinaemia can occur in patients with a complete remission after Kymriah infusion.
Danish: Hypogammaglobulinæmi og agammaglobulinæmi kan forekomme hos patienter med komplet remission efter infusion af Kymriah.
English: • Administer high-dose or multiple vasopressors, oxygen, mechanical ventilation and/or other supportive care as needed.
Danish: • Administrer højdosis vasopressor eller flere vasopressorer, oxygen, mekanisk ventilation og/eller anden understøttende behandling efter behov.