FrancophonIA/ELRC3.0 huggingface dataset:
English: YESCARTA will only be supplied to hospitals and associated centres that are qualified and only if the healthcare professionals involved in the treatment of a patient have completed the educational program.
Danish: YESCARTA må kun udleveres til kvalificerede hospitaler og tilknyttede klinikker og kun hvis sundhedspersonalet, der er involveret i behandlingen af en patient, har gennemført uddannelsesprogrammet.
English: YESCARTA is made from your own white blood cells and should only be given to you.
Danish: YESCARTA er fremstillet af dine egne hvide blodlegemer og må kun gives til dig.
English: There are no available data with YESCARTA use in pregnant women.
Danish: Der er ingen tilgængelige data vedrørende anvendelse af YESCARTA til gravide kvinder.
English: Generally, safety and efficacy were similar between patients ≥ 65 years and patients < 65 years of age treated with
Danish: Generelt var sikkerhed og virkning sammenlignelig mellem patienter ≥ 65 år og patienter < 65 år, der er i behandling med YESCARTA.
English: Sodium chloride Human albumin
Danish: Natriumchlorid Humant albumin
English: Verify patient ID.
Danish: Bekræft patient-ID.
English: Based on the mechanism of action, if the transduced cells cross the placenta, they may cause foetal toxicity, including B-cell lymphocytopenia.
Danish: Baseret på virkningsmekanismen kan de transducerede celler, hvis de krydser placenta, forårsage fostertoksicitet, inklusive B-celle lymfopeni.
English: YESCARTA must not be irradiated.
Danish: YESCARTA må ikke udsættes for stråling.
English: - Decrease in the number of cells that help clot the blood (thrombocytopenia).
Danish: Reduceret antal celler, som hjælper blodet med at størkne (trombocytopeni).
English: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion.
Danish: Patienter kan udvise cytopenier i flere uger efter lymfocytdepleterende kemoterapi og infusion af YESCARTA.
English: Analyses performed to identify associations between cytokine levels and incidence of CRS or neurologic events showed that higher levels (peak and AUC at 1 month) of IL-15, as well as IL-6, were associated with Grade 3 or higher neurologic adverse reactions and Grade 3 or higher CRS.
Danish: Analyser udført for at identificere forbindelser mellem cytokinniveauer og forekomst af CRS eller neurologiske hændelser viste, at højere niveauer (peakværdi og AUC ved 1 måned) af IL-15, såvel som IL-6, var forbundet med grad 3 eller højere neurologiske bivirkninger og grad 3 eller højere CRS.
English: Patients should be monitored for signs and symptoms of neurologic adverse reactions (Table 2).
Danish: Patienterne skal monitoreres for tegn og symptomer på neurologiske bivirkninger (Tabel 2).
English: - Signs and symptoms of blood clots.
Danish: Tegn og symptomer på blodpropper.
English: Dysphagia is a recognised symptom of encephalopathy which is currently listed in the product information; however, dysphagia can lead to serious complications and may require specific clinical measures.
Danish: Dysfagi er et velkendt symptom på encefalopati, som er anført i den nuværende produktinformation, men dysfagi kan medføre alvorlige komplikationer og kræve specifikke kliniske tiltag.
English: It will not be given to you again.
Danish: Du vil ikke få behandlingen igen.
English: See the prescribing information for lymphodepleting chemotherapy for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy.
Danish: Se ordinationsoplysningerne for lymfocytdepleterende kemoterapi for information om behovet for effektiv kontraception hos patienter, som modtager den lymfocytdepleterende kemoterapi.
English: The safety of immunisation with live viral vaccines during or following YESCARTA treatment has not been studied.
Danish: Sikkerheden af immunisering med levende virusvacciner under eller efter behandling med YESCARTA er ikke blevet undersøgt.
English: Assessment of immunoglobulin levels and B-cells in newborns of mothers treated with YESCARTA should be considered.
Danish: Det skal overvejes at vurdere immunglobulinniveauer og B-celler hos nyfødte af kvinder behandlet med YESCARTA.
English: The median duration of follow up was 27.4 months.
Danish: Den gennemsnitlige varighed af opfølgning var 27,4 måneder.
English: Signs and symptoms of TLS should be monitored and events managed according to standard guidelines.
Danish: Tegn og symptomer på TLS bør monitoreres, og bivirkninger behandles i overensstemmelse med standard retningslinjer.
English: Patients should be monitored for signs and symptoms of infection before, during, and after YESCARTA infusion and treated appropriately.
Danish: Patienterne skal monitoreres for tegn og symptomer på infektion før, under og efter infusion af YESCARTA og behandles derefter.
English: YESCARTA has major influence on the ability to drive and use machines.
Danish: YESCARTA påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Work surfaces and material which have potentially been in contact with YESCARTA must be decontaminated with appropriate disinfectant.
Danish: Arbejdsflader og materiale, som kan have været i kontakt med YESCARTA, skal dekontamineres med et hensigtsmæssigt desinfektionsmiddel.
English: YESCARTA can cause side effects to your immune system that may be serious or life-threatening, and can lead to death.
Danish: YESCARTA kan forårsage bivirkninger for dit immunsystem, som kan være alvorlige eller livstruende, og som kan være dødelige.
English: Eligible patients were ≥ 18 years of age with refractory disease defined as progressive disease (PD) or stable disease (SD) as best response to last line of therapy, or disease progression within 12 months after autologous stem cell transplant (ASCT).
Danish: Egnede patienter var ≥ 18 år med refraktær sygdom defineret som progressiv sygdom (PD) eller stabil sygdom (SD) som bedste respons på sidstevalgsbehandling eller sygdomsprogression inden for 12 måneder efter autolog stamcelletransplantation (ASCT).
English: Patients treated with YESCARTA should not donate blood, organs, tissues, and cells for transplantation.
Danish: Patienter i behandling med YESCARTA må ikke donere blod, organer, væv og celler til transplantation.
English: To minimise the risks associated with the treatment of YESCARTA, the MAH must ensure that hospitals and their associated centres that dispense YESCARTA are specially qualified in accordance with the agreed control distribution program.
Danish: Med henblik på at mindske risiciene forbundet med behandlingen med YESCARTA skal indehaveren af markedsføringstilladelsen sikre, at hospitaler og tilknyttede klinikker, som dispenserer YESCARTA, er specielt kvalificerede i overensstemmelse med det aftalte kontroldistributionsprogram.
English: YESCARTA must be administered in a qualified clinical setting.
Danish: YESCARTA skal administreres i et kvalificeret klinisk behandlingscenter.
English: Neurologic adverse reactions occurred in 67% of patients.
Danish: Neurologiske bivirkninger forekom hos 67 % af patienterne.
English: - Changes in the rhythm or rate of the heartbeat.
Danish: Ændringer i hjerterytme eller hjertefrekvens.
English: Administer tocilizumab (c) 8 mg/kg intravenously over 1 hour (not to exceed 800 mg).
Danish: Administrér tocilizumab (c) 8 mg/kg intravenøst over 1 time (højst 800 mg).
English: Of 111 patients who underwent leukapheresis, 101 received YESCARTA.
Danish: Ud af de 111 patienter, som gennemgik leukaferese, modtog 101 YESCARTA.
English: Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered.
Danish: Patienter med signifikant kardiel dysfunktion skal behandles med standarder for kritisk behandling, og foranstaltninger som f.eks. ekkokardiografi skal overvejes.
English: YESCARTA will always be given to you by a healthcare professional.
Danish: Du vil altid få YESCARTA af sundhedspersonale.
English: Prior to receiving YESCARTA, you will be given other medicines such as preparative chemotherapy, which will allow your modified white blood cells in YESCARTA to multiply in your body when the medicine is given to you.
Danish: Inden du får YESCARTA, vil du få andre lægemidler, såsom forberedende kemoterapi, som vil give dine modificerede hvide blodlegemer i YESCARTA mulighed for at formere sig i kroppen, når du får medicinen.
English: Patient Educational program
Danish: Uddannelsesprogram til patienter
English: If you have lymphoma this might include fever, feeling weak, night sweats, sudden weight loss.
Danish: Hvis du har lymfom, kan det inkludere feber, svaghed, nattesved, pludseligt vægttab.
English: This will show if you are likely to develop a condition called tumour lysis syndrome.
Danish: Det vil vise, om du har sandsynlighed for at udvikle en tilstand kaldet tumorlysesyndrom.
English: The analysis included patients who had not responded (SD or PD) to their last line of therapy, or had relapsed within 12 months after ASCT.
Danish: Analysen inkluderede patienter, som ikke havde udvist respons (SD eller PD) på deres sidste behandling, eller som havde recidiveret inden for 12 måneder efter ASCT.
English: The ORR results within PMBCL and DLBCL arising from follicular lymphoma were both 88%.
Danish: ORR-resultaterne i PMBCL og DLBCL transformeret fra follikulært lymfom var begge 88 %.
English: - Difficulty understanding numbers, memory loss, fits, loss of control of body movements.
Danish: Besvær med at forstå tal, hukommelsestab, krampeanfald, tab af kontrol over kropsbevægelser.
English: After you have been given YESCARTA Tell your doctor or nurse immediately if you have any of the following:
Danish: Efter du har fået indgivet YESCARTA Fortæl straks lægen eller sygeplejersken, hvis du oplever noget af følgende:
English: A retrospective, patient-level, pooled analysis of outcomes in refractory aggressive NHL (N = 636) was conducted (Crump et al., 2017) to provide confirmation of the prespecified control response rate of 20% and historical context for interpreting the ZUMA-1 results.
Danish: En retrospektiv, samlet analyse af resultater på patientniveau ved refraktær aggressiv NHL (N = 636) blev udført (Crump et al., 2017) for at bekræfte den forud specificerede kontrolresponsrate på 20 % og historisk kontekst for fortolkning af ZUMA-1 resultaterne.
English: Cumulatively, 33 (31%) of 108 subjects received intravenous immunoglobulin therapy at the time of the 24-month analysis.
Danish: 33 (31 %) af 108 forsøgspersoner modtog kumulativt intravenøs immunglobulinterapi på tidspunktet for 24-måneders analysen.
English: Allergic reactions may occur with the infusion of YESCARTA.
Danish: Allergiske reaktioner kan forekomme ved infusion af YESCARTA.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CONTAINER (CASSETTE)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE BEHOLDER (KASSETTE)
English: • Infuse the entire content of the YESCARTA bag within 30 minutes by either gravity or a peristaltic pump.
Danish: • Indgiv hele indholdet af posen med YESCARTA inden for 30 minutter enten via almindeligt drop eller ved brug af en peristaltisk pumpe.
English: Due to the potential for neurologic events, including altered mental status or seizures, patients should refrain from driving or operating heavy or potentially dangerous machines until at least 8 weeks after infusion or until resolution of neurologic adverse reactions.
Danish: På grund af muligheden for neurologiske bivirkninger, inklusive ændret mentaltilstand eller krampeanfald, skal patienterne undgå at føre motorkøretøj eller betjene tunge eller potentielt farlige maskiner mindst 8 uger efter infusionen, eller indtil de neurologiske bivirkninger er gået væk.
English: YESCARTA bags must be stored in the vapour phase of liquid nitrogen (≤ -150 ˚C) and YESCARTA must remain frozen until the patient is ready for treatment to ensure viable live autologous cells are administered to the patient.
Danish: Poser med YESCARTA skal opbevares i dampformen af flydende kvælstof (≤ -150 °C), og YESCARTA skal forblive nedfrosset, indtil patienten er klar til behandling for at sikre, at levedygtige levende autologe celler administreres til patienten.
English: YESCARTA contains sodium
Danish: YESCARTA indeholder natrium
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: - have problems with your nervous system (such as fits, stroke, or memory loss).
Danish: - Har problemer med nervesystemet (f.eks. anfald, slagtilfælde eller hukommelsestab).
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering vises bivirkningerne efter aftagende sværhedsgrad.
English: • Thaw YESCARTA at approximately 37 °C using either a water bath or dry thaw method until there is no visible ice in the infusion bag.
Danish: • Optø YESCARTA ved cirka 37 °C enten i et vandbad eller ved brug af en metode til tør optøning, indtil der ikke er mere synligt is i infusionsposen.
English: The ORR was 26% [95% CI (21, 31)] and the CR rate was 7% [95% CI (3, 15)], with a median OS of 6.3 months.
Danish: ORR var 26 % [95 % KI (21, 31)], og CR-raten var 7 % [95 % KI (3, 15)], med en gennemsnitlig OS på 6,3 måneder.
English: If no improvement within 24 hours after starting tocilizumab, administer dexamethasone 10 mg intravenously every 6 hours if not already taking other corticosteroids.
Danish: Hvis der ikke ses forbedring inden for 24 timer efter start af tocilizumab, administreres dexamethason 10 mg intravenøst hver 6. time, hvis patienten ikke allerede tager andre kortikosteroider.
English: If you miss any appointments, call your doctor or the qualified clinical facility as soon as possible to reschedule your appointment.
Danish: Hvis du ikke kommer til et aftalt besøg, skal du ringe til lægen eller den kvalificerede klinik hurtigst muligt for at aftale en ny tid.
English: Before you are given YESCARTA you should tell your doctor if you:
Danish: Inden du får YESCARTA skal du fortælle din læge hvis du:
English: Educational program - Prior to the launch of YESCARTA in each Member State the MAH must agree the content and format of the educational materials with the National Competent Authority.
Danish: Uddannelsesprogram - Inden lancering af YESCARTA i hvert medlemsland, skal indehaveren af markedsføringstilladelsen blive enig med den nationale kompetente myndighed om indholdet og formatet af uddannelsesmaterialet.
English: All material that has been in contact with YESCARTA (solid and liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local biosafety guidelines.
Danish: Alt materiale, der har været i kontakt med YESCARTA (fast og flydende affald), skal håndteres og bortskaffes som potentielt smittefarligt affald i overensstemmelse med lokale retningslinjer vedrørende biosikkerhed.
English: Serious hypersensitivity reactions including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA.
Danish: Alvorlige overfølsomhedsreaktioner inkluderer anafylaksi, som kan skyldes dimethylsulfoxid (DMSO) eller residuel gentamicin i YESCARTA.
English: The MAH shall ensure that in each Member State where YESCARTA is marketed, all HCPs who are expected to prescribe, dispense, and administer YESCARTA shall be provided with a guidance document to: - facilitate identification of CRS and serious neurologic adverse reactions - facilitate management of the CRS and serious neurologic adverse reactions - ensure adequate monitoring of CRS and serious neurologic adverse reactions - facilitate provision of all relevant information to patients - ensure that adverse reactions are adequately and appropriately reported - ensure that detailed instructions about the thawing procedure are provided - before treating a patient, ensure that 4 doses of tocilizumab for each patient are available on site
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale som forventes at ordinere, dispensere og administrere YESCARTA i alle medlemslande, hvor YESCARTA markedsføres, får udleveret et vejledende dokument med henblik på at: gøre det lettere at identificere CRS og alvorlige neurologiske bivirkninger gøre det lettere at behandle CRS og alvorlige neurologiske bivirkninger sikre tilstrækkelig monitorering af CRS og alvorlige neurologiske bivirkninger gøre det lettere at udlevere al relevant information til patienter sikre at bivirkninger rapporteres tilstrækkeligt og hensigtsmæssigt sikre at der gives detaljerede instruktioner om optøningsproceduren sikre inden behandling af en patient, at der er 4 doser med tocilizumab tilgængelig på stedet til hver patient
English: Some people may feel tired, dizzy or have some shaking after being given YESCARTA.
Danish: Nogle patienter kan være trætte, svimle eller opleve rysten, efter de får YESCARTA.
English: Discuss pregnancy with your doctor if you have received YESCARTA.
Danish: Tal med din læge om graviditet, hvis du har fået YESCARTA.
English: HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells.
Danish: Reaktivering af HBV, der i visse tilfælde kan medføre fulminant hepatitis, leversvigt og død, kan forekomme hos patienter behandlet med lægemidler, der er rettet mod B-celler.
English: Non-sedating, anti-seizure medicines should be considered as clinically indicated for Grade 2 or higher adverse reactions.
Danish: Ikke-sederende antiepileptisk medicin skal overvejes som klinisk indiceret for bivirkninger af grad 2 eller højere.
English: • Since YESCARTA is made from your own white blood cells, your cells will be collected from you to prepare your medicine.
Danish: • Da YESCARTA er fremstillet af dine egne hvide blodlegemer, vil dine celler blive udtaget fra dig til fremstilling af din medicin.
English: Patients must have received at least prior anti-CD20 antibody therapy and an anthracycline containing regimen.
Danish: Patienter skal have modtaget mindst en tidligere anti-CD20 antistof-behandling og et behandlingsregime, som indeholdt antracyklin.
English: Febrile neutropenia was observed in 36% of patients after YESCARTA infusion.
Danish: Febril neutropeni blev observeret hos 36 % af patienterne efter infusion af YESCARTA.
English: • Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.
Danish: • Patienterne skal instrueres om at forblive nær en kvalificeret klinik i mindst 4 uger efter infusion.
English: The requirements for submission of PSUR for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på det europæiske lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Cytokine release syndrome
Danish: Cytokin release syndrom
English: Patients with active CNS disorder or inadequate renal, hepatic, pulmonary, or cardiac function are likely to be more vulnerable to the consequences of the adverse reactions described below and require special attention.
Danish: Patienter med aktiv CNS-sygdom eller utilstrækkelig nyre-, lever-, lunge- eller hjertefunktion er sandsynligvis mere følsomme over for konsekvenserne af de bivirkninger, der er beskrevet nedenfor, og disse patienter kræver særlig opmærksomhed.
English: This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhoea and bloody stools.
Danish: Dette sker, når transplanterede celler angriber din krop, og giver symptomer som f.eks. udslæt, kvalme, opkastning, diarré og blod i afføringen.
English: On the basis of the scientific conclusions for axicabtagene ciloleucel the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing axicabtagene ciloleucel is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for axicabtagene ciloleucel er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder axicabtagene ciloleucel, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: All patients were hospitalized for observation for a minimum of 7 days after YESCARTA infusion.
Danish: Alle patienter var indlagt til observation i mindst 7 dage efter infusion af YESCARTA.
English: These include the use of tocilizumab or tocilizumab and corticosteroids for moderate, severe, or life-threatening CRS as summarised in Table 1.
Danish: Disse inkluderer anvendelse af tocilizumab eller tocilizumab og kortikosteroider til behandling af moderat, alvorlig eller livstruende CRS, som opsummeret i Tabel 1.
English: Overall Survival, median (months) [95% CI]
Danish: Samlet overlevelse, gennemsnit (måneder) [95% KI]
English: - Inflammation and swelling of spinal cord which may cause partial or total paralysis of limbs and torso.
Danish: Betændelse og hævelse i rygmarven, hvilket kan forårsage delvis eller total lammelse af lemmer og overkrop.
English: See section 4.4 for monitoring and management guidance.
Danish: 4.4 for vejledning vedrørende monitorering og behandling.
English: • Central venous access is recommended for the administration of YESCARTA.
Danish: • Det anbefales at bruge et centralt venekateter til administration af YESCARTA.
English: Contents: approximately 68 mL of cell dispersion.
Danish: Indhold: cirka 68 ml celledispersion.
English: - Swelling in the limbs, fluid around the lungs (pleural effusion).
Danish: Hævelse i lemmerne, væske omkring lungerne (pleuraekssudat).
English: Therefore, YESCARTA is not recommended for women who are pregnant, or for women of childbearing potential not using contraception.
Danish: YESCARTA anbefales derfor ikke til gravide kvinder, eller til fertile kvinder, som ikke anvender kontraception.
English: Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment with YESCARTA.
Danish: Vaccination med levende virusvacciner anbefales ikke i mindst 6 uger inden start af lymfocytdepleterende kemoterapi, under behandling med YESCARTA og før genetablering af immunfunktion efter behandling med YESCARTA.
English: Ensure that a minimum of 4 doses of tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, are available for each patient prior to infusion of YESCARTA.
Danish: Sørg for, at mindst 4 doser af tocilizumab, en interleukin-6 (IL-6) receptorhæmmer, er tilgængelige for hver patient inden infusion af YESCARTA.
English: - Low oxygen level in blood.
Danish: Lavt iltniveau i blodet.
English: • YESCARTA is the genetically modified version of your white blood cells.
Danish: • YESCARTA er den genetisk modificerede form af dine hvide blodlegemer.
English: - have any lung, heart or blood pressure (low or raised) problems.
Danish: - Har problemer med lunge, hjerte eller blodtryk (lavt eller højt).
English: For severe or life-threatening CRS, consider intensive-care supportive therapy.
Danish: Ved svær eller livstruende CRS skal intensiv understøttende behandling overvejes.
English: - Low blood pressure, dizziness.
Danish: Lavt blodtryk, svimmelhed.
English: Adverse reactions reported from clinical trials and post-marketing setting are presented below.
Danish: Rapporterede bivirkninger i kliniske forsøg og efter markedsføringen vises nedenfor.