FrancophonIA/ELRC3.0 huggingface dataset:
English: Diagnosis of CRS requires excluding alternate causes of systemic inflammatory response, including infection.
Danish: Diagnosticering af CRS kræver udelukkelse af andre årsager til systemisk inflammatorisk respons, herunder infektion.
English: If your temperature is high, see your doctor immediately.
Danish: Hvis du har høj temperatur, skal du straks søge læge.
English: • Check your blood for uric acid and for how many cancer cells there are in your blood.
Danish: • Kontrollere dit blod for urinsyre og for hvor mange kræftceller, der er i blodet.
English: 24-month analysis
Danish: 24-måneders analyse
English: In the phase 1 part of ZUMA-1, 7 patients were treated.
Danish: I fase 1-delen af ZUMA-1 blev 7 patienter behandlet.
English: Your doctor will recommend that you return to the hospital daily for at least 10 days and will consider whether you need to stay at the hospital as an in-patient for the first 10 days after infusion.
Danish: Din læge vil anbefale, at du vender tilbage til hospitalet dagligt i mindst 10 dage og vil overveje, om du skal indlægges på hospitalet og blive der i de første 10 dage efter infusionen.
English: CR rates were 75% and 56%, respectively.
Danish: CR-raten var henholdsvis 75 % og 56 %.
English: Too many of these abnormal white blood cells accumulate in your tissue and this is the cause of the symptoms you may have.
Danish: For mange af disse abnorme hvide blodlegemer akkumuleres i dit væv og er årsagen til de symptomer, du måske oplever.
English: The ORR was prespecified to be tested in the first 92 treated patients and was significantly higher than the prespecified rate of 20% (P < 0.0001).
Danish: ORR var præspecificeret til at blive testet hos de første 92 behandlede patienter og var signifikant højere end den præspecificerede rate på 20 % (P < 0,0001).
English: Symptoms require and respond to moderate intervention.
Danish: Symptomer kræver og reagerer på moderat indgriben.
English: The anticipated metabolic products are typical cellular degradation products resulting from normal cellular clearance mechanisms.
Danish: De forventede metaboliske produkter er typisk cellulære nedbrydningsprodukter, der er et resultat af normale cellulære clearance-mekanismer.
English: - High blood pressure.
Danish: Højt blodtryk.
English: 12-month analysis
Danish: 12-måneders analyse
English: This can lead to a weight gain and difficulty in breathing.
Danish: Dette kan medføre vægtstigning og vejrtrækningsbesvær.
English: - Decrease in the number of white blood cells, which are important for fighting infections.
Danish: Reduceret antal hvide blodlegemer, som er vigtige for at bekæmpe infektioner.
English: • An antihistamine such as diphenhydramine.
Danish: • Et antihistaminpræparat, såsom diphenhydramin.
English: However, YESCARTA infusion should begin within 30 minutes of thaw completion and the total YESCARTA infusion time should not exceed 30 minutes.
Danish: Infusion af YESCARTA skal dog begynde inden for 30 minutter efter fuld optøning, og den samlede infusionstid af YESCARTA må ikke overstige 30 minutter.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Danish: Denne indlægsseddel findes på alle EU/EØS-sprog på Det Europæiske Lægemiddelagenturs hjemmeside.
English: CRS occurred in 93% of patients.
Danish: CRS forekom hos 93 % af patienterne.
English: ORR (%) [95% CI] CR (%)
Danish: ORR (%) [95% KI] CR (%)
English: In the event that a secondary malignancy occurs, contact the company to obtain instructions on patient samples to collect for testing.
Danish: Hvis der opstår en sekundær malignitet, kontaktes virksomheden for at få instruktioner i hvilke patientprøver, der skal indsamles til testning.
English: Due to the risks associated with YESCARTA treatment, infusion should be delayed if a patient has any of the following conditions:
Danish: På grund af de risici, der er forbundet med behandling med YESCARTA, skal infusion udsættes, hvis en patient har en af følgende tilstande:
English: - Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it. - Always show the Patient Alert Card to the doctor or nurse when you see them or if you go to hospital.
Danish: Læs det grundigt og følg instruktionerne på det. - Vis altid patientinformationskortet til lægen eller sygeplejersken, når du ser dem, eller hvis du tager på hospitalet.
English: Age (range: 23 to 76 years) and sex had no significant impact on AUC and Cmax of YESCARTA.
Danish: Alder (interval 23 til 76 år) og køn havde ingen signifikant indvirkning på YESCARTA's AUC og Cmax.
English: Five patients responded, including 4 CRs.
Danish: Fem patienter udviste respons, inklusive 4 CR'er.
English: Repeat tocilizumab every 8 hours as needed if not responsive to intravenous fluids or increasing supplemental oxygen.
Danish: Gentag tocilizumab hver 8. time efter behov, hvis ikke responsiv over for intravenøse væsker eller øgning af supplerende ilt.
English: YESCARTA is intended solely for autologous use and must not be administered to other patients.
Danish: YESCARTA er udelukkende beregnet til autolog anvendelse og må ikke gives til andre patienter.
English: Ninety-eight percent (98%) of patients recovered from CRS.
Danish: Otteoghalvfems procent (98 %) af patienterne kom sig over CRS.
English: Symptoms require and respond to aggressive intervention.
Danish: Symptomer kræver og reagerer på aggressiv indgriben.
English: No studies have been conducted to evaluate the effects of YESCARTA on fertility, reproduction, and development.
Danish: Ingen undersøgelser er blevet udført for at evaluere effekterne af YESCARTA på fertilitet, reproduktion og udvikling.
English: Infections occurred in 39% of patients in ZUMA-1.
Danish: Infektioner forekom hos 39 % af patienterne i ZUMA-1.
English: YESCARTA is a clear to opaque, white to red dispersion for infusion, supplied in an infusion bag individually packed in a metal cassette.
Danish: YESCARTA er en klar til uigennemsigtig, hvid til rød dispersion til infusion, der leveres i en infusionspose individuelt emballeret i en metalkassette.
English: Do not use this medicine after the expiry date which is stated on the container label and infusion bag.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på beholderens etiket og infusionsposen.
English: • Your white blood cells are frozen and sent away to make YESCARTA.
Danish: • Dine hvide blodlegemer nedfryses og sendes væk til fremstilling af YESCARTA.
English: - Infections in the blood caused by bacteria, viruses or other types of infection.
Danish: Infektioner i blodet forårsaget af bakterier, virusser eller andre typer infektion.
English: Three patients tested positive for anti-FMC63 prior to being treated with YESCARTA.
Danish: Tre af patienterne blev testet positive for anti-FMC63, inden de blev behandlet med YESCARTA.
English: • Prophylactic use of systemic corticosteroids is not recommended as it may interfere with the activity of YESCARTA.
Danish: • Profylaktisk anvendelse af systemiske kortikosteroider anbefales ikke, da det kan påvirke aktiviteten af YESCARTA.
English: Serious adverse reactions occurred in 56% of patients.
Danish: Alvorlige bivirkninger forekom hos 56 % af patienterne.
English: NE= Not estimable (not reached) a Duration of response was censored at the time of SCT for subjects who received SCT while in response.
Danish: NE= Kan ikke estimeres (ikke nået) a Varigheden af responset blev undersøgt på tidspunktet for SCT for forsøgspersoner, som modtog SCT, mens de var i respons.
English: Additional Patient ID: Patient Name:
Danish: Andet patient-ID: Patientens navn:
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 før håndtering og administration af lægemidlet Dette lægemiddel indeholder genetisk modificerede humane blodceller.
English: Consider alternate immunosuppressants if no improvement or if condition worsens.
Danish: Overvej andre immunosupprimerende midler, hvis der ikke ses bedring, eller hvis tilstanden forværres.
English: Secondary endpoints included duration of response (DOR), overall survival (OS), and severity of adverse events.
Danish: Sekundære endepunkter inkluderede varighed af responset (DOR), samlet overlevelse (OS) og sværhedsgrad af bivirkninger.
English: This is the equivalent to 15% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Det svarer til 15 % af det maksimale anbefalede daglige indtag af natrium i kosten for en voksen.
English: If this happens to you, do not drive or use heavy machines until at least 8 weeks after infusion or until your doctor tells you that you have completely recovered.
Danish: Hvis dette sker for dig, må du ikke føre motorkøretøj eller betjene tunge maskiner, før mindst 8 uger efter infusion, eller før din læge fortæller dig, at du er kommet dig helt.
English: Summary of demographics for ZUMA-1 phase 2 (12 month analysis)
Danish: Tabel 4: Sammenfatning af demografi for ZUMA-1 fase 2 (12-måneders analyse)
English: This medicine contains 300 mg sodium (main component of cooking/table salt) in each infusion.
Danish: Dette lægemiddel indeholder 300 mg natrium (hovedkomponenten i køkkensalt) i hver infusion.
English: - Low levels of antibodies called immunoglobulins, which may lead to infections.
Danish: Lave niveauer af antistoffer kaldet immunglobuliner, hvilket kan medføre infektioner.
English: These events were considered as syndromes of neurologic toxicity, an important identified risk of axicabtagene ciloleucel use.
Danish: Disse hændelser blev betragtet som neurologiske toksicitetssyndromer, en vigtig identificeret risiko ved brug af axicabtagene ciloleucel.
English: Effects on male and female fertility have not been evaluated in animal studies.
Danish: Effekten på fertilitet hos hun- og handyr er ikke blevet undersøgt i dyreforsøg.
English: • Plan to stay within proximity from the hospital where you were treated for at least 4 weeks after you have been given YESCARTA.
Danish: • Planlæg at blive nær hospitalet, hvor du blev behandlet, i mindst 4 uger efter at du har fået YESCARTA.
English: Do NOT use a leukodepleting filter.
Danish: Anvend IKKE et lymfocytdepleterende filter.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: not yet assigned
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske midler, ATC-kode: endnu ikke tildelt.
English: Tests and checks Before you are given YESCARTA your doctor will:
Danish: Prøver og kontroller Inden du får indgivet YESCARTA, vil din læge:
English: Limit to a maximum of 3 doses in a 24 hour period; maximum total of 4 doses if no clinical improvement in the signs and symptoms of CRS.
Danish: Begræns til maksimum 3 doser inden for 24 timer; i alt maksimum 4 doser, hvis der ikke ses forbedring af tegn og symptomer på CRS.
English: Administer tocilizumab per Table 1 for management of Grade 2 CRS.
Danish: Administrér tocilizumab som anført i Tabel 1 til behandling af Grad 2 CRS.
English: Of the 111 patients in the ITT population, the ORR was 66% and the CR was 47%.
Danish: Blandt de 111 patienter i ITT-populationen var ORR 66 % og CR var 47 %.
English: 2132 NT Hoofddorp The Netherlands
Danish: 2132 NT Hoofddorp Nederlandene
English: - Dehydration.
Danish: Dehydrering.
English: 1098 XH Amsterdam The Netherlands
Danish: 1098 XH Amsterdam Nederlandene
English: The number of anti-CD19 CAR T cells in the blood was positively associated with objective response (CR or PR).
Danish: Antallet af anti-CD19 CAR T-celler i blodet var positivt forbundet med objektivt respons (CR eller PR).
English: YESCARTA should not be used in children and adolescents below 18 years of age.
Danish: YESCARTA må ikke bruges til børn og unge under 18 år.
English: The active substance is axicabtagene ciloleucel.
Danish: Aktivt stof: axicabtagene ciloleucel.
English: Prophylactic anti-microbials should be administered according to standard institutional guidelines.
Danish: Profylaktiske antimikrobielle lægemidler skal administreres i henhold til institutionens standard retningslinjer.
English: Talk to your doctor if you need to have any vaccinations.
Danish: Fortæl det til din læge, hvis du skal vaccineres.
English: Your doctor may need to take special care of you during your treatment with YESCARTA.
Danish: Din læge skal muligvis give dig særbehandling under din behandling med YESCARTA.
English: - have an infection.
Danish: - Har en infektion.
English: YESCARTA should not be administered to patients with active infections or inflammatory disease until these conditions have resolved.
Danish: YESCARTA må ikke administreres til patienter med aktive infektioner eller inflammatorisk sygdom, før disse tilstande er ophørt.
English: No dose adjustment is required in patients ≥ 65 years of age.
Danish: Det er ikke nødvendigt at justere dosis hos patienter i alderen ≥ 65 år.
English: Only cytopenias that resulted in (i) new or worsening clinical sequelae or (ii) that required therapy or (iii) adjustment in current therapy are included in Table 3.
Danish: Kun cytopenier, som resulterede i (i) nye eller forværrede kliniske sequelae, eller (ii) som krævede behandling eller (iii) justering af den aktuelle behandling, er medtaget i tabel 3.
English: Most patients recovered from neurologic adverse reactions, with the exception of 4 patients who had ongoing neurologic adverse reactions at the time of death; the deaths were due to other causes.
Danish: De fleste patienter kom sig over de neurologiske bivirkninger, med undtagelse af 4 patienter, som fortsat havde neurologiske bivirkninger på tidspunktet for deres død; dødsfaldene skyldtes andre årsager.
English: Note: The 12-month analysis had a median follow-up of 15.1 months.
Danish: Note: 12-måneders analysen havde en gennemsnitlig opfølgning på 15,1 måned.
English: - Sudden, unexpected stopping of the heart (cardiac arrest); this is serious and life-threatening.
Danish: Pludseligt, uventet hjertestop; dette er alvorligt og livstruende.
English: Forty-seven patients were evaluable for MYC, BCL-2, and BCL-6 status.
Danish: Syvogfyrre patienter var evaluerbare for MYC, BCL-2 og BCL-6 status.
English: One cryostorage bag is individually packed in a shipping cassette.
Danish: En fryse-opbevaringspose er pakket individuelt i en forsendelseskassette.
English: Patients treated with YESCARTA may develop secondary malignancies.
Danish: Patienter i behandling med YESCARTA kan udvikle sekundære maligniteter.
English: • If you are pregnant or think you may be pregnant after treatment with YESCARTA, talk to your doctor immediately.
Danish: • Hvis du er gravid eller tror, at du kan være gravid efter behandling med YESCARTA, skal du straks fortælle det til din læge.
English: Levels of cytokines and chemokines such as IL-6, IL-8, IL-10, IL-15, TNF-α, IFN-γ, and IL2Rα were analyzed.
Danish: Niveauer af cytokiner og kemokiner, såsom IL-6, IL-8, IL-10, IL-15, TNF-α, IFNγ og IL2Rα, blev analyseret.
English: • A leukodepleting filter must not be used.
Danish: • Et lymfocytdepleterende filter må ikke anvendes.
English: Therefore, the risk/benefit of YESCARTA has not been established in this population.
Danish: Benefit/risk-forholdet ved brug af YESCARTA er derfor ikke klarlagt hos denne population.
English: Your doctor may do blood tests to check for side effects.
Danish: Din læge vil muligvis tage blodprøver for at kontrollere for bivirkninger.
English: The primary endpoint was objective response rate (ORR).
Danish: Det primære endepunkt var samlet responsrate (ORR).
English: It usually takes about 3 to 4 weeks to receive your YESCARTA therapy but the time may vary.
Danish: Det tager sædvanligvis cirka 3 til 4 uger, inden du får din behandling med YESCARTA, men tidsrummet kan variere.
English: • Place the infusion bag inside a second sterile bag or per local guidelines.
Danish: • Anbring infusionsposen i en anden steril pose eller i henhold til lokale retningslinjer.
English: This is because the effects of YESCARTA in pregnant or breast-feeding women are not known, and it may harm your unborn baby or your breast-fed child.
Danish: Det er fordi, virkningerne af YESCARTA hos gravide eller ammende kvinder er ukendte, og det kan skade dit ufødte barn eller dit ammede barn.
English: You must receive YESCARTA infusion in a qualified clinical facility and be discharged only when your doctor thinks it is safe for you to go home.
Danish: Du skal have infusionen af YESCARTA på en kvalificeret klinik og vil først blive udskrevet, når din læge mener, at det er sikkert for dig at tage hjem.
English: Unspecified pathogen infections Viral infections
Danish: Uspecificerede patogene infektioner Virale infektioner
English: • In the 6 weeks before you are given the short course of chemotherapy (called lymphodepleting chemotherapy) to prepare your body for the YESCARTA cells.
Danish: • Inden for de 6 uger før du får det korte forløb af kemoterapi (kaldet lymfocytdepleterende kemoterapi) for at forberede din krop til YESCARTA-cellerne.
English: - Decrease in the number of red blood cells (cells that carry oxygen) which may cause you to feel extremely tired with a loss of energy.
Danish: - Reduktion i antallet af røde blodlegemer (celler som transporterer ilt), som kan medføre, at du føler dig ekstremt træt og ikke har nogen energi.
English: YESCARTA continues to expand and persist following administration of tocilizumab and corticosteroids.
Danish: YESCARTA fortsætter med at ekspandere og vedvare efter administration af tocilizumab og kortikosteroider.
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 din læge til råds, før du får dette lægemiddel.
English: Availability of tocilizumab and site qualification
Danish: Tocilizumabs tilgængelighed og kvalificering af klinik
English: Manage per Grade 3 if no improvement within 24 hours after starting tocilizumab.
Danish: Behandl som grad 3, hvis der ikke ses forbedring inden for 24 timer efter start af tocilizumab.
English: Do not donate blood, organs, tissues or cells for transplants.
Danish: Du må ikke donere blod, organer, væv eller celler til transplantater.
English: This medicinal product contains 300 mg sodium per infusion, equivalent to 15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 300 mg natrium pr. infusion, svarende til 15 % af den af WHO anbefalede maksimale daglige indtagelse på 2 g natrium for en voksen.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for axicabtagene ciloleucel, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for axicabtagene ciloleucel er CHMP nået frem til følgende videnskabelige konklusioner:
English: In ZUMA-1, hypogammaglobulinaemia occurred in 16% of patients.
Danish: I ZUMA-1 forekom hypogammaglobulinæmi hos 16 % af patienterne.
English: There is limited experience with YESCARTA in patients ≥ 75 years of age.
Danish: Der er begrænset erfaring med YESCARTA hos patienter i alderen ≥ 75 år.
English: No reproductive and developmental toxicity animal studies have been conducted with YESCARTA to assess whether it can cause foetal harm when administered to a pregnant woman (see section 5.3).
Danish: Der er ikke udført dyreforsøg for reproduktions- og udviklingstoksicitet med YESCARTA med henblik på at vurdere, om det kan forårsage fosterskade, hvis det administreres til en gravid kvinde (se pkt.
English: STOP confirm patient ID prior to infusion.
Danish: STOP, bekræft patient-ID inden infusion.
English: In phase 2 of ZUMA-1, after YESCARTA infusion, pharmacodynamic responses were evaluated over a 4-week interval by measuring transient elevation of cytokines, chemokines, and other molecules in blood.
Danish: I fase 2 af ZUMA-1, efter infusion af YESCARTA, blev det farmakodynamiske respons evalueret henover et 4-ugers interval ved at måle forbigående forhøjelse af cytokiner, kemokiner og andre molekyler i blodet.
English: Age (years) Median (min, max)
Danish: Alder (år) Gennemsnit (min, maks.)
English: Tell your doctor immediately if you get any of the side effects listed above.
Danish: Fortæl straks lægen, hvis du oplever nogen af de ovenstående bivirkninger.
English: The safety and efficacy of YESCARTA in children and adolescents below 18 years of age have not yet been established.
Danish: Sikkerhed og virkning af YESCARTA hos børn og unge under 18 år er endnu ikke klarlagt.
English: Screening for HBV, HCV, and HIV should be performed in accordance with clinical guidelines before collection of cells for manufacturing of YESCARTA.
Danish: Screening for HBV, HCV og hiv skal foretages i overensstemmelse med kliniske retningslinjer inden udtagning af celler til fremstilling af YESCARTA.
English: - If YESCARTA infusion is delayed for more than 2 weeks after you have received preparatory chemotherapy you may have to receive more preparative chemotherapy.
Danish: Hvis infusion af YESCARTA forsinkes med mere end 2 uger efter du har fået den forberedende kemoterapi, skal du muligvis have yderligere forberedende kemoterapi.
English: YESCARTA is to be administered via intravenous infusion.
Danish: YESCARTA skal administreres via intravenøs infusion.
English: The median duration of follow up was 27.1 months (still ongoing).
Danish: Den gennemsnitlige varighed af opfølgning var 27,1 måneder (stadig igangværende).
English: Hence, traditional toxicology studies used for drug development were not performed.
Danish: Derfor blev traditionelle toksikologiske undersøgelser som normalt anvendes ved lægemiddeludvikling ikke udført.
English: Before you are given YESCARTA tell your doctor or nurse if you are taking any medicines that weaken your immune system such as corticosteroids, since these medicines may interfere with the effect of YESCARTA.
Danish: Inden du får YESCARTA, skal du fortælle lægen eller sygeplejersken, hvis du tager anden medicin, som svækker dit immunsystem, såsom kortikosteroider, da denne medicin kan påvirke effekten af YESCARTA.
English: Annual safety reports and 5-yearly interim reports
Danish: •Opdatering af rapporter: Årlige sikkerhedsrapporter og interimrapporter hvert 5. år
English: • Fits, shaking, or difficulty speaking or slurred speech, loss of consciousness or decreased level of consciousness, confusion and disorientation, loss of balance or coordination.
Danish: • Anfald, rysten, eller talebesvær eller slørret tale, bevidsthedstab eller nedsat bevidsthedsniveau, forvirring og desorientering, tab af balance eller koordinationsevne.
English: Nine patients were not treated, primarily due to progressive disease or serious adverse events after enrolment and prior to cell delivery.
Danish: Ni patienter blev ikke behandlet, primært på grund af progressiv sygdom eller alvorlige bivirkninger efter inkludering og inden infusion af celler til patienten.
English: For patients experiencing severe CRS, consider performing an echocardiogram to assess cardiac function.
Danish: For patienter, der oplever svær CRS, skal det overvejes at foretage et ekkokardiogram for at vurdere hjertefunktionen.
English: There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with YESCARTA.
Danish: Der foreligger ikke tilstrækkelige eksponeringsdata til at give en anbefaling vedrørende varigheden af kontraception efter behandling med YESCARTA.
English: Provide intensive-care supportive therapy for severe or lifethreatening neurologic toxicities.
Danish: Giv intensiv understøttende behandling for alvorlige eller livstruende neurologiske toksiciteter.
English: The following side effects have been reported with YESCARTA.
Danish: Følgende bivirkninger er blevet rapporteret med YESCARTA.