FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to Kymriah infusion, infection prophylaxis should follow standard guidelines based on the degree of preceding immunosuppression.
Danish: Infektionsprofylakse forud for infusion af Kymriah bør følge standardretningslinjer baseret på graden af forudgående immunsupprimering.
English: • An antihistamine such as diphenhydramine.
Danish: • Et antihistamin, fx diphenhydramin.
English: Of 165 patients enrolled, 111 patients received infusion with Kymriah (4 infusions were pending at the time of analysis); for 12 patients (7%) Kymriah could not be manufactured.
Danish: Af de 165 inkluderede patienter fik 111 patienter infusion med Kymriah (4 infusioner var forestående på analysetidspunktet); for 12 patienter (7 %) kunne Kymriah ikke fremstilles.
English: • You have had hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
Danish: • Du har haft hepatitis B, hepatitis C eller humant immundefektvirus (HIV) infektion.
English: In Studies B2202 and B2205J there were 79.8% Caucasian, 7.7% Asian and 12.5% other ethnic patients.
Danish: I studie B2202 og B2205J var der 79,8 % kaukasiere, 7,7 % asiater og 12,5 % patienter af anden etnisk oprindelse.
English: Not reached (10.0, NE4) Not reached (10.0, NE4)
Danish: Ikke nået (10,0, NE4)
English: • Low or raised blood pressure
Danish: • Lavt eller højt blodtryk
English: Pregnancy status for females of child-bearing age should be verified prior to starting treatment with Kymriah.
Danish: Graviditetsstatus hos kvinder i den fødedygtige alder bør verificeres, før behandling med Kymriah startes.
English: Dispersion for infusion 10 mL - 50 mL per bag.
Danish: Infusionsvæske, dispersion 10 ml - 50 ml pr. pose.
English: Limit to a maximum total of 4 tocilizumab doses.
Danish: Den maksimale dosis af tocilizumab er 4 doser.
English: The scatter plots of cellular kinetic parameters versus age (22-76 years) revealed no relevant relationship between cellular kinetic parameters (AUC0-28d and Cmax) with age.
Danish: Scatter-plot af cellekinetiske parametre versus alder (22-76 år) viste ingen relevant sammenhæng mellem cellekinetiske parametre (AUC0-28d og Cmax) og alder.
English: • Rapid breakdown of tumour cells causing release of their contents into the bloodstream.
Danish: • Hurtig nedbrydning af tumorceller, hvilket medfører frigivelse af deres indhold til blodet.
English: Due to the risks associated with Kymriah treatment, infusion should be delayed if a patient has any of the following conditions: - Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions or hypotension) from preceding chemotherapies.
Danish: På grund af de risici, som er forbundet med behandling med Kymriah, skal infusionen tilbageholdes, hvis patienten har nogle af de følgende tilstande: - Uafklarede alvorlige bivirkninger (særligt pulmonære reaktioner, kardielle reaktioner eller hypotension) fra foregående kemoterapier.
English: Haemodynamic instability despite intravenous fluids and vasopressor support
Danish: Hæmodynamisk instabilitet trods intravenøs væske og understøttende behandling med vasopressor
English: Geometric mean (CV%), n
Danish: Geometrisk middelværdi (CV%), n
English: Headache includes headache and migraine.
Danish: Hovedpine omfatter hovedpine og migræne.
English: In the event of febrile neutropenia, infection should be evaluated and managed appropriately with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated.
Danish: I tilfælde af febril neutropeni bør infektion evalueres og håndteres passende med bredspektrumantibiotika, væske og anden understøttende behandling, som medicinsk indiceret.
English: For storage conditions after thawing of the medicinal product, see section 6.3.
Danish: For opbevaringsforhold efter optøning af lægemidlet, se pkt.
English: • No formal studies have been performed in paediatric patients below 3 years of age in B-cell ALL.
Danish: • Der er ikke udført kontrollerede forsøg med pædiatriske patienter under 3 år for B-celle ALL.
English: Kymriah is not recommended if the patient has relapsed with CD19-negative leukaemia after prior anti-CD19 therapy.
Danish: Kymriah anbefales ikke, hvis patienten har relaps af CD19-negativ leukæmi efter tidligere anti-CD19 terapi.
English: The availability of tocilizumab at all hospitals and associated centres must be ensured by the MAH until an authorised treatment for CRS is available in the EU.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at tocilizumab er tilgængelig på alle hospitaler og tilhørende centre indtil en godkendt behandling af CRS er tilgængelig i EU.
English: As appropriate, prophylactic antibiotics should be administered and surveillance testing should be employed prior to and during treatment with Kymriah.
Danish: Profylaktiske antibiotika bør administreres efter behov, og der bør foretages overvågningsanalyser før og under behandling med Kymriah.
English: Non-responding patients (NR) N=11
Danish: Ikke-responderende patienter (NR) N=11
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 produktresuméet for lymfodepleterende kemoterapi for oplysninger om behovet for sikker kontraception hos patienter, som får lymfodepleterende kemoterapi.
English: • Check for hepatitis B, hepatitis C or HIV infection.
Danish: • Undersøge for hepatitis B, hepatitis C eller HIV-infektion.
English: Disease status (%) Refractory to last line of therapy Relapse to last line of therapy
Danish: Sygdomsstatus (%) Refratær for sidste behandlingslinje Recidiverende for sidste behandlingslinje
English: This medicinal product contains 24.3 to 121.5 mg sodium per dose, equivalent to 1 to 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 24,3 til 121,5 mg natrium pr. dosis, svarende til 1 til 6 % af den WHO anbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: All material that has been in contact with Kymriah (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 Kymriah (fast og flydende affald), skal håndteres og bortskaffes som potentielt smittefarligt affald i henhold til lokale retningslinjer for biosikkerhed.
English: Age (years) Mean (standard deviation) Median (minimum - maximum) Age category (years) - n (%) <65 years ≥65 years Sex - n (%) Male Female Prior haematopoietic stem cell transplant (SCT) - n (%) No Yes Stage III/IV disease at study entry - n (%) No Yes Number of prior lines of antineoplastic therapy - n (%)
Danish: Alder (år) Middelværdi (standardafvigelse) Median (minimal - maksimal) Aldergruppe (år) - n (%) <65 år ≥65 år Køn - n (%) Mænd Kvinder Tidligere hæmatopoietisk stamcelletransplantation (SCT) - n (%) Nej Ja Stadie III/IV-sygdom ved inkludering i studiet - n (%) Nej Ja Antal tidligere antineoplastiske behandlingslinjer - n (%)
English: The type and duration of bridging therapy was left to the discretion of the physician.
Danish: Type og varighed af den brobyggende behandling var op til den behandlende læge.
English: Kymriah treatment should be delayed in some patient groups at risk (see section 4.4).
Danish: Kymriah behandling skal tilbageholdes hos visse risikopatienter (se pkt.
English: Sleep disorder includes sleep disorder, insomnia and nightmare.
Danish: Søvnproblemer omfatter søvnproblemer, insomni og mareridt.
English: The blood to bone marrow partitioning in bone marrow was nearly 70% of that present in blood at day 28 and 50% at month 3 in both responder and non-responder patients.
Danish: Blod/knoglemarvfordelingen i knoglemarven var næsten 70 % af det, der var til stede i blodet, ved dag 28 og 50 % ved måned 3 hos både responderende og ikke-responderende patienter.
English: The blood to bone marrow partitioning of tisagenlecleucel in bone marrow was 47.2% of that present in blood at day 28 while at months 3 and 6 it distributes at 68.3% and 69%, respectively (Studies B2202 and B2205J).
Danish: Blod/knoglemarv-fordelingen af tisagenlecleucel i knoglemarven var 47,2 % af det, der var til stede i blodet, ved dag 28, mens det ved måned 3 og 6 fordeler sig med henholdsvis 68,3 % og 69 % (Studierne B2202 og B2205J).
English: The median time to onset of neurological events was 7 days in B-cell ALL and DLBCL.
Danish: Mediantiden til fremkomst af neurologiske hændelser var 7 dage i B-celle ALL og DLBCL.
English: Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Danish: Patienter, der er serumpositive for hepatitis B-virus (HBV), hepatitis C-virus (HCV) eller humant immundefektvirus (HIV)
English: Hypogammaglobulinaemia was reported in 47% of patients treated with Kymriah for r/r ALL and 14% of patients with r/r DLBCL.
Danish: Hypogammaglobulinæmi blev rapporteret hos 47 % af patienterne, der blev behandlet med Kymriah mod r/r ALL og 14 % af patienterne med r/r DLBCL.
English: In clinical studies, humoral immunogenicity of tisagenlecleucel was measured by determination of anti-murine CAR19 antibodies (anti-mCAR19) in serum pre- and post-administration.
Danish: I kliniske studier blev tisagenlecleucels humorale immunogenicitet målt ved bestemmelse af anti-murine CAR19-antistoffer (anti-mCAR19) i serum før og efter administration.
English: • Low urine output, dark urine
Danish: • Nedsat vandladning, mørk urin
English: Blood, organ, tissue and cell donation
Danish: Blod-, organ-, vævs- og celledonation
English: Kymriah is prepared from autologous blood of the patient collected by leukapheresis.
Danish: Kymriah fremstilles ud fra patientens autologe blod, som indsamles ved leukaferese.
English: Neurological events, in particular encephalopathy, confusional state or delirium, occur frequently with Kymriah and can be severe or life-threatening (see section 4.8).
Danish: Neurologiske hændelser, særligt encefalopati, konfusion eller delirium, forekommer hyppigt med Kymriah og kan være svære eller livstruende (se pkt.
English: Kymriah should be thawed at 37°C using either a water bath or dry thaw method until there is no visible ice in the infusion bag.
Danish: Kymriah skal optøs ved 37 °C ved brug af enten et vandbad eller en tør optøningsmetode, indtil der ikke er synlig is i infusionsposen.
English: % relapse free probability at 6 months % relapse free probability at 12 months Other secondary endpoints
Danish: % recidivfri sandsynlighed efter 6 måneder % recidivfri sandsynlighed efter 12 måneder Andre sekundære endepunkter
English: Contains genetically-modified cells.
Danish: Indeholder genetisk modificerede celler.
English: Patient leukapheresis material and Kymriah may carry a risk of transmitting infectious viruses to healthcare professionals handling the product.
Danish: Leukaferesemateriale fra patienten og Kymriah kan medføre en risiko for overførsel af smittefarlige vira til læger og øvrigt sundhedspersonale, der håndterer produktet.
English: Responding patients (CR and PR) N=35
Danish: Responderende patienter (CR og PR) N=35
English: Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of cytokine release syndrome and/or neurological events.
Danish: Læger bør overveje indlæggelse i de første 10 dage efter infusion eller ved de første tegn/symptomer på cytokinfrigivelsessyndrom og/eller neurologiske hændelser.
English: Of four patients with active CNS leukaemia (i.e. CNS-3) included in study B2101J, three experienced cytokine release syndrome (Grade 2-4) and transient neurological abnormalities (Grade 1-3) that resolved within 1-3 months of infusion.
Danish: Ud af fire patienter med aktiv CNS-leukæmi (dvs. CNS-3) inkluderet i studiet B2101J, oplevede tre cytokinfrigivelsessyndrom (grad 2-4) og forbigående neurologiske abnormaliteter (grad 1-3), som forsvandt inden for 1-3 måneder efter infusionen.
English: Attention to signs and symptoms of infection should be implemented according to age and standard specific guidelines.
Danish: Der skal ydes hurtig opmærksomhed på tegn og symptomer på infektion, i henhold til alder og specifikke standardretningslinjer.
English: Store and transport below -120°C.
Danish: Opbevares og transporteres ved temperaturer under -120 °C.
English: 43% of the patients experienced an infection of any type within 8 weeks after Kymriah infusion.
Danish: 43 % af patienterne oplevede en infektion af nogen type inden for 8 uger efter infusion af Kymriah.
English: Administer antipyretics, oxygen, intravenous fluids and/or low-dose vasopressors as needed.
Danish: Administrer antipyretika, oxygen, intravenøs væske og/eller lav dosis af vasopressorer efter behov.
English: • Difficulty sleeping
Danish: • Søvnproblemer
English: Diffuse large B-cell lymphoma (DLBCL)
Danish: Diffust storcellet B-celle lymfom (DLBCL)
English: In adult DLBCL patients (Study C2201), tisagenlecleucel has been detected for up to 2 years in peripheral blood and up to month 9 in bone marrow for complete responder patients.
Danish: Hos voksne DLBCL-patienter (studie C2201) er tisagenlecleucel blevet påvist i op til 2 år i perifert blod og op til måned 9 i knoglemarven for patienter med komplet respons.
English: • feeling warm, fever, chills or shivering, sore throat or mouth ulcers may be signs of an infection.
Danish: • varmefølelse, feber, kuldegysninger, kulderystelser, ondt i halsen eller mundsår - kan være tegn på en infektion.
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 forårsager symptomer som udslæt, kvalme, opkastning, diarré og blodig afføring.
English: Cytokine release syndrome was graded with the Penn scale as follows: Grade 1: mild reactions, e.g. reactions requiring supportive care; Grade 2: moderate reactions, e.g. reactions requiring intravenous therapies; Grade 3: severe reactions, e.g. reactions requiring low-dose vasopressors or supplemental oxygen; Grade 4: life-threatening reactions, e.g. those requiring high-dose vasopressors or intubation; Grade 5: death.
Danish: Cytokinfrigivelsessyndrom blev klassificeret på baggrund af Penn-skalaen som følger: Grad 1: milde reaktioner, fx reaktioner, der kræver understøttende behandling; Grad 2: moderate reaktioner, fx reaktioner, der kræver intravenøs behandling; Grad 3: svære reaktioner, fx reaktioner, der kræver behandling med lav-dosis vasopressor eller supplerende oxygen; Grad 4: livstruende reaktioner, fx reaktioner, der kræver behandling med høj-dosis vasopressor eller intubering; Grad 5: død.
English: Store and transport below -120°C; do not thaw the product until use.
Danish: Opbevares og transporteres ved temperaturer under -120 °C; produktet må ikke optøs, før det skal anvendes.
English: The adverse reactions described in this section were identified in 111 patients infused with Kymriah in one global multicentre international study, i.e. the ongoing pivotal clinical study CCTL019C2201.
Danish: De bivirkninger, der er beskrevet i dette afsnit, blev identificeret hos 111 patienter, infunderet med Kymriah i ét globalt internationalt multicenterstudie, dvs. det igangværende pivotale kliniske studie CCTL019C2201.
English: • Bleeding or bruising more easily, which may be symptoms of low levels of cells in the blood known as platelets.
Danish: • Haft lettere ved at få blødninger og blå mærker, som kan være symptomer på lavt antal celler i blodet kaldet blodplader.
English: Observe in person; exclude infection; administer antibiotics per local guidelines if neutropenic; provide symptomatic support.
Danish: Observer personligt, udeluk infektion, administrer antibiotika i henhold til lokale retningslinjer, hvis netropeni forekommer, giv symptomatisk støtte.
English: Myeloid growth factors, particularly granulocyte macrophage-colony stimulating factor (GM-CSF), have the potential to worsen cytokine release syndrome symptoms and are not recommended during the first 3 weeks after Kymriah infusion or until cytokine release syndrome has resolved.
Danish: Myeloide vækstfaktorer, særligt granulocyt-makrofag-kolonistimulerende faktor (GM-CSF), har potentiale til at forværre cytokinfrigivelsessyndrom symptomer, og anbefales ikke i løbet af de første 3 uger efter infusion af Kymriah, eller før cytokinfrigivelsessyndrom er forsvundet.
English: Anti-IL-6 based therapy such as tocilizumab has been administered for moderate or severe cytokine release syndrome associated with Kymriah and a minimum of four doses of tocilizumab must be on site and available for administration prior to Kymriah infusion.
Danish: Anti-IL-6-baseret terapi som fx tocilizumab er blevet administreret ved moderat eller svært cytokinfrigivelsessyndrom forbundet med Kymriah, og mindst fire doser tocilizumab skal være på stedet og være tilgængelig til administration forud for infusion af Kymriah.
English: • Your doctor will check that the individual patient identifiers on the Kymriah infusion bag match up to you.
Danish: • Lægen vil kontrollere, at oplysningerne om din identitet på Kymriah-infusionsposen stemmer overens med, hvem du er.
English: This medicinal product contains 10 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL.
Danish: Dette lægemiddel indeholder 10 mg dextran 40 og 82,5 mg dimethylsulfoxid (DMSO) pr. ml.
English: Precautions to be taken before handling or administering Kymriah Kymriah contains genetically-modified human blood cells.
Danish: Forsigtighedshensyn, der skal tages før håndtering eller administrering af Kymriah Kymriah indeholder genetisk modificerede humane blodceller.
English: Infections and febrile neutropenia
Danish: Infektioner og febril neutropeni
English: The co-administration of agents known to stimulate T-cell function has not been investigated and the effects are unknown.
Danish: Samtidig administration af stoffer, der vides at stimulere T-celle funktionen er ikke blevet undersøgt og effekten er ikke kendt.
English: • Diffuse large B-cell lymphoma (DLBCL) - another form of cancer that affects some types of white blood cells, mostly in the lymph nodes.
Danish: • Diffust storcellet B-celle lymfom (DLBCL) - en anden form for kræft, der rammer visse typer hvide blodlegemer, for det meste i lymfeknuderne.
English: Delirium includes agitation, delirium, hallucination, hallucination visual, irritability and restlessness.
Danish: Delirium omfatter agitation, delirium, hallucinationer, synshallucinationer, irritabilitet og rastløshed.
English: • The active substance of Kymriah is called tisagenlecleucel.
Danish: • Aktivt stof: tisagenlecleucel.
English: Infused patients N=75
Danish: Infunderede patienter N=75
English: For autologous use only.
Danish: Udelukkende til autolog anvendelse.
English: The MAH shall ensure that in each Member State where KYMRIAH is marketed, all HCPs who are expected to prescribe, dispense annd administer KYMRIAH shall be provided with a guidance document to: - facilitate identification of CRS and serious neurological adverse reactions - facilitate management of the CRS and serious neurological adverse reactions - ensure adequate monitoring of CRS and serious neurological 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: I hvert medlemsland hvor Kymriah er markedsført, skal indehaveren af markedsføringstilladelsen sikre, at alle læger og sundhedspersonale som ordinerer, dispenserer og administrerer Kymriah modtager et vejledningsdokument til at: - lette identifikationen af CRS og alvorlige neurologiske bivirkninger - lette håndteringen af CRS og alvorlige neurologiske bivirkninger - sikre tilstrækkelig monitorering af CRS og alvorlige neurologiske bivirkninger - lette videregivelsen af alle relevante oplysninger til patienter - sikre, at bivirkninger bliver indberettet tilstrækkeligt og på passende vis - sikre, at detaljerede instruktioner om optøningsproceduren er givet - sikre, at stedet har 4 doser tocilizumab tilgængelig til hver patient før patienten behandles
English: • Excessive or prolonged bleeding or bruising
Danish: • Kraftig eller langtrukken blødning eller dannelse af blå mærker
English: Kymriah intravenous infusion should be administered by a healthcare professional experienced with immunosuppressed patients and prepared to manage anaphylaxis.
Danish: Intravenøs infusion af Kymriah skal administreres af sundhedspersonale med erfaring i immunsupprimerede patienter og forberedt på håndtering af anafylaksi.
English: Abdominal pain includes abdominal pain, abdominal pain upper and abdominal discomfort.
Danish: Abdominalsmerter omfatter abdominalsmerter, smerter i den øvre del af abdomen og abdominalt ubehag.
English: • Excessive sweating, night sweats
Danish: • Overdrevet svedtendens, nattesved
English: If the infusion bag appears to have been damaged or to be leaking, it should not be infused and should be disposed of according to local biosafety procedures.
Danish: Hvis infusionsposen synes at være blevet beskadiget eller at lække, må indholdet ikke infunderes og skal bortskaffes i henhold til lokale procedurer vedrørende biosikkerhed.
English: If there is a delay of more than 4 weeks between completing lymphodepleting chemotherapy and the infusion and the WBC count is >1,000 cells/μL, then the patient should be re-treated with lymphodepleting chemotherapy prior to receiving Kymriah.
Danish: Hvis der er en forsinkelse på mere end 4 uger mellem gennemførelse af lymfodepleterende kemoterapi og infusionen, og WBC er >1.000 celler/μl, bør patienten genbehandles med lymfodepleterende kemoterapi, før patienten får Kymriah.
English: Grade 3 and 4 adverse reactions were reported in 89% of patients.
Danish: Bivirkninger af grad 3 og 4 blev rapporteret hos 89 % af patienterne.
English: • Abnormal blood test results (high level of: uric acid, glucose; low level of: phosphorus, calcium,
Danish: • Unormale blodprøveresultater (højt niveau af: urinsyre, glukose; lavt niveau af: fosfor, calcium,
English: Confirm the infusion time in advance, and adjust the start time for thaw so that Kymriah is available for infusion when the recipient is ready.
Danish: Bekræft infusionstidspunktet på forhånd, og juster starttidspunktet for optøning, så Kymriah er tilgængeligt til infusion, når recipienten er klar.
English: Seizure includes seizure, generalised tonic-clonic seizures and status epilepticus.
Danish: Krampeanfald omfatter krampeanfald, generaliserede tonisk-kloniske anfald og status epilepticus.
English: Administration of low-dose steroids as per the cytokine release syndrome treatment algorithm does not impact the expansion and persistence of CAR-T cells.
Danish: Administration af lavdosis steroid i henhold til behandlingsalgoritmen for cytokinfrigivelsessyndrom påvirker ikke ekspansionen og overlevelsen af CAR-T cellerne.
English: To inform and explain to patients: - the risks of CRS and serious neurological adverse reactions associated with KYMRIAH - the need to report the symptoms to their treating doctor immediately - the need to remain in the proximity of the location where KYMRIAH was received for at least
Danish: Til at informere og forklare patienter om: - risikoen for CRS og alvorlige neurologiske bivirkninger, som er forbundet med Kymriah - behovet for straks at rapportere af symptomer til deres behandlende læge - behovet for at blive i nærheden af stedet, hvor Kymriah blev givet i mindst 4 uger efter infusion af Kymriah - behovet for altid at bære patientinformationskortet på sig
English: The adverse reactions described in this section were identified in 75 and 111 patients in the ongoing multicentre pivotal clinical studies (CCTL019B2202 and CCTL019C2201).
Danish: Bivirkningerne beskrevet i dette afsnit blev identificeret i 75 og 111 patienter i de igangværende multicenter pivotale klinisk studier (CCTL019B2202 og CCTL019C2201).