FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with BLINCYTO can cause a decrease in the levels of certain white blood cells with or without fever (febrile neutropenia or neutropenia) or can lead to increased blood levels of potassium, uric acid, and phosphate and decreased blood levels of calcium (tumour lysis syndrome).
Danish: Behandling med BLINCYTO kan forårsage et fald i niveauerne af bestemte hvide blodlegemer med eller uden samtidig feber (febril neutropeni eller neutropeni) eller kan føre til forhøjede niveauer i blodet af kalium, urinsyre og fosfat og nedsatte niveauer i blodet af calcium (tumorlysesyndrom).
English: A total of 456 patients aged ≥ 18 years of age with relapsed or refractory B-precursor ALL were exposed to BLINCYTO during the phase II and phase III clinical studies described below.
Danish: I alt 456 patienter på ≥ 18 år med recidiveret eller refraktær B-prækursor ALL blev eksponeret for BLINCYTO i de kliniske fase II- og fase III-studier, der beskrives nedenfor.
English: The estimated mean (SD) systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 2.92 (2.83) L/hour.
Danish: Den estimerede gennemsnitlige (SD) systemiske clearance ved kontinuerlig intravenøs infusion til patienter, der fik blinatumomab i kliniske studier, var 2,92 (2,83) l/t.
English: If you have minimal residual disease acute lymphoblastic leukaemia, your dose of BLINCYTO will be 28 micrograms per day throughout the first cycle.
Danish: Hvis du har minimal residual sygdom i forbindelse med akut lymfoblastisk leukæmi, vil din dosis af BLINCYTO være 28 mikrogram pr. dag i den første cyklus.
English: One case of fatal encephalopathy has been reported in an earlier phase II clinical single-arm study.
Danish: Der er rapporteret et enkelt tilfælde af fatal encefalopati i et tidligere klinisk fase II-studie med én behandlingsarm.
English: It is very important that the instructions for preparation (including reconstitution and dilution) and administration are strictly followed to minimise medication errors (including underdose and overdose) (see section 4.2).
Danish: Det er meget vigtigt, at anvisningerne til klargøring (herunder rekonstitution og fortynding) og administration følges nøje for at minimere risikoen for medicineringsfejl (herunder underdosering og overdosering) (se pkt.
English: Leukoencephalopathy including progressive multifocal leukoencephalopathy
Danish: Leukoencefalopati, herunder progressiv multifokal leukoencefalopati
English: If the toxicity takes more than 14 days to resolve, discontinue BLINCYTO permanently, except if described differently in the table below.
Danish: Hvis det varer mere end 14 dage, før toksiciteten svinder, seponeres BLINCYTO permanent, medmindre andet er oplyst i nedenstående tabel.
English: Eighty-eight out of 113 (77.9%) evaluable patients achieved a complete MRD response after one cycle of treatment; see table 5.
Danish: Otteogfirs ud af 113 (77,9 %) evaluerbare patienter opnåede komplet MRD-respons efter én cyklus af behandling; se tabel 5.
English: No studies have been conducted to evaluate treatment-related effects on fertility.
Danish: Der er ikke udført studier med undersøgelse af de behandlingsrelaterede virkninger på fertiliteten.
English: Patients received BLINCYTO at a constant dose of 15 mcg/m2/day (equivalent to the recommended dosage of 28 mcg/day) for all treatment cycles.
Danish: Patienterne fik BLINCYTO med en konstant dosis på 15 mikrog/m2/dag (svarende til den anbefalede dosis på 28 mikrog/dag) i alle behandlingscyklusser.
English: Your doctor or nurse will monitor you for signs and symptoms of these reactions.
Danish: Lægen eller sundhedspersonalet vil holde øje med, om du får tegn og symptomer på disse reaktioner.
English: Additional information is provided in “Description of selected adverse reactions”.
Danish: Infusionsrelaterede reaktioner a Der er yderligere information under “Beskrivelse af udvalgte bivirkninger”.
English: BLINCYTO was also evaluated in an open-label, multicentre, single-arm phase II study of 189 patients.
Danish: BLINCYTO blev også undersøgt i et åbent fase II-multicenterstudie med en enkelt behandlingsarm med 189 patienter.
English: It is recommended that a neurological examination be performed in patients prior to starting BLINCYTO therapy and that patients be clinically monitored for signs and symptoms of neurologic events (e.g. writing test).
Danish: Det anbefales at gennemføre en neurologisk undersøgelse på patienterne, inden behandling med BLINCYTO starter, og at patienterne monitoreres klinisk for tegn og symptomer på neurologiske hændelser (fx en skrivetest).
English: • if you have severe and persistent stomach pain, with or without nausea and vomiting, as these may be symptoms of a serious and potentially fatal condition known as pancreatitis (inflammation of the pancreas).
Danish: • Hvis du får kraftig og vedvarende mavepine med eller uden kvalme og opkastning, da det kan være symptomer på en alvorlig og potentielt dødelig tilstand, der kaldes for pancreatitis (betændelse i bugspytkirtlen).
English: • Description on patient's monitoring and management of early signs and symptoms of neurological events
Danish: • Beskrivelse af monitoreringen af patienterne og håndtering af tidlige tegn og symptomer på neurologiske hændelser
English: In patients receiving blinatumomab, serious infections, including sepsis, pneumonia, bacteraemia, opportunistic infections and catheter site infections have been observed, some of which were lifethreatening or fatal.
Danish: Der er observeret alvorlige infektioner hos patienter, der fik blinatumomab, herunder sepsis, pneumoni, bakteriæmi, opportunistiske infektioner og infektioner på kateterstedet, hvoraf nogle var livstruende eller fatale.
English: Partial remission was defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.
Danish: 4 Delvis remission blev defineret som blastceller i knoglemarv på 6 % til 25 % med en reduktion på mindst 50 %
English: - performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Danish: Klargøringen af BLINCYTO skal: - udføres under aseptiske forhold af uddannet personale i overensstemmelse med reglerne for god praksis, især hvad angår aseptisk tilberedning af parenterale produkter.
English: The anti-tumour activity of blinatumomab immunotherapy is not dependent on T-cells bearing a specific TCR or on peptide antigens presented by cancer cells, but is polyclonal in nature and independent of human leukocyte antigen (HLA) molecules on target cells.
Danish: Antitumoraktiviteten i immunterapi med blinatumomab afhænger ikke af, at T-cellerne bærer en specifik TCR eller af peptidantigener, der er indeholdt i cancerceller, men er polyklonal i beskaffenhed og uafhængig af humane leukocytantigen-molekyler (HLA-molekyler) på målceller.
English: In adult patients, dexamethasone 20 mg intravenous should be administered 1 hour prior to initiation of each cycle of BLINCYTO therapy.
Danish: Hos voksne patienter bør intravenøs dexamethason 20 mg administreres 1 time inden initiering af hver cyklus med BLINCYTO-behandling.
English: Diluted solution (prepared infusion bag): If your infusion bag is changed at home: - Infusion bags containing BLINCYTO solution for infusion will arrive in special packaging containing cooling packs.
Danish: Fortyndet opløsning (klargjort infusionspose): Hvis din infusionspose skiftes hjemme hos dig selv: - Infusionsposerne med BLINCYTO infusionsvæske, opløsning, vil ankomme i en speciel pakning med køleelementer.
English: What you need to know before you use BLINCYTO
Danish: Det skal du vide, før du begynder at bruge BLINCYTO
English: The median time to onset to the first event was 4 days from the start of BLINCYTO treatment initiation.
Danish: Mediantiden indtil den første hændelses indtræden var 4 dage fra starten af behandling med BLINCYTO.
English: Confusion and disorientation, coordination and balance disorders, risk of seizures and disturbances in consciousness can occur (see section 4.4).
Danish: Der kan opstå konfusion og desorientering, koordinations- og balanceforstyrrelser, risiko for krampeanfald og bevidsthedsforstyrrelser (se pkt.
English: Based on pharmacokinetic analyses, no effect of baseline liver function on blinatumomab exposure is expected and adjustment of the initial dose is not necessary (see section 5.2).
Danish: På baggrund af farmakokinetiske analyser forventes der ingen virkning af leverfunktionen ved baseline på blinatumomabs eksponering, og justering af initialdosis er ikke nødvendig (se pkt.
English: Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/or clinical improvement after 1 treatment cycle should be assessed by the treating physician.
Danish: Derfor skal den behandlende læge vurdere de potentielle fordele og risici i forbindelse med fortsat behandling af patienter, som ikke viser hæmatologisk og/eller klinisk bedring efter 1 behandlingscyklus.
English: Women who are able to become pregnant have to use effective contraception during treatment and for at least 48 hours after your last treatment.
Danish: Kvinder, der kan blive gravide, skal bruge sikker prævention under behandlingen og i mindst 48 timer efter den sidste behandling.
English: Using a syringe, reconstitute each vial of BLINCYTO powder for concentrate using 3 mL of water for injections.
Danish: Brug en sprøjte, rekonstituér hvert hætteglas med BLINCYTO pulver til koncentrat med anvendelse af 3 ml vand til injektionsvæsker.
English: 48 hours
Danish: 48 timer
English: Repeat-dose toxicity studies conducted with blinatumomab and the murine surrogate revealed the expected pharmacologic effects (including release of cytokines, decreases in leukocyte counts, depletion of B-cells, decreases in T-cells, decreased cellularity in lymphoid tissues).
Danish: Studier af toksicitet efter gentagne doser, der blev gennemført med blinatumomab og det murine surrogat, viste de forventede farmakologiske virkninger (herunder frigivelse af cytokiner, fald i leukocyttal, depletering af B-celler, fald i T-celler, nedsat cellularitet i lymfoide væv).
English: BLINCYTO has been evaluated in paediatric patients with relapsed or refractory B-precursor ALL in a phase I/II dose escalation/evaluation study, in which 70 paediatric patients, aged 7 months to 17 years, were treated with the recommended dosage regimen.
Danish: BLINCYTO er blevet undersøgt på pædiatriske patienter med recidiveret eller refraktær B-prækursor ALL i et fase I/II-studie med dosiseskalering/-evaluering, hvor 70 pædiatriske patienter i alderen 7 måneder til 17 år blev behandlet med det anbefalede doseringsregime.
English: Patients who responded to BLINCYTO but later relapsed had the option to be retreated with BLINCYTO.
Danish: Patienter, der responderede på BLINCYTO, men senere fik tilbagefald, havde mulighed for at blive genbehandlet med BLINCYTO.
English: The expected depletions of B and T-cells were observed in the pregnant mice but haematological effects were not assessed in foetuses.
Danish: De forventede depleteringer af B- og T-celler blev observeret hos drægtige mus, men de hæmatologiske virkninger blev ikke undersøgt på fostre.
English: It is also used in patients with acute lymphoblastic leukaemia who still have a small number of cancer cells remaining after previous treatment (referred to as minimal residual disease).
Danish: BLINCYTO anvendes også til patienter med akut lymfoblastisk leukæmi, som stadig har et lille antal cancerceller tilbage efter tidligere behandling (det kaldes minimal residual sygdom).
English: In case of suspicious events consider consultation with a neurologist, brain MRI and examination of cerebral spinal fluid (CSF), see section 4.8.
Danish: I tilfælde af mistænkelige hændelser bør konsultation hos en neurolog, MRI af hjernen og undersøgelse af cerebrospinalvæsken (CSV) overvejes, se pkt.
English: Adverse reactions that were observed more frequently (≥ 10% difference) in the paediatric population compared to the adult population were anaemia, thrombocytopenia, leukopenia, pyrexia, infusion-related reactions, weight increase, and hypertension.
Danish: Bivirkninger, der blev observeret hyppigere (≥ 10 % forskel) i den pædiatriske population sammenlignet med den voksne population, var anæmi, trombocytopeni, leukopeni, pyreksi, infusionsrelaterede reaktioner, vægtstigning og hypertension.
English: • Remarks on the importance of reporting ADRs
Danish: • Bemærkninger om vigtigheden af at indberette lægemiddelbivirkninger
English: 1/Complete remission with partial haematological recovery (CRh*) CR
Danish: 1/komplet remission med delvis hæmatologisk genoprettelse (CRh*) CR
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan ramme mere end 1 ud af 10 personer):
English: Monitoring of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and total blood bilirubin prior to the start of and during BLINCYTO treatment especially during the first 48 hours of the first 2 cycles should be performed.
Danish: Alaninaminotransferase (ALAT), aspartataminotransferase (ASAT), gammaglutamyltransferase (GGT) og total bilirubin i blodet bør monitoreres inden behandlingens start og under behandling med BLINCYTO, især i de første 48 timer af de første to cyklusser.
English: Cytokine storm
Danish: Cytokinstorm
English: No dose adjustment is necessary in elderly patients (≥ 65 years of age), see section 5.1.
Danish: Der er ikke behov for justering af dosis til ældre patienter (≥ 65 år), se pkt.
English: Patients receiving BLINCYTO should be clinically monitored for signs and symptoms of infection and treated appropriately.
Danish: Patienter, der får BLINCYTO, skal monitoreres klinisk for tegn og symptomer på infektion og behandles om nødvendigt.
English: Four patients achieved CR during consolidation cycles, resulting in a cumulative CR rate of 35.4% (67/189; 95% CI: 28.6% - 42.7%).
Danish: Fire patienter opnåede CR i cyklusser med konsolidationsbehandling, hvilket gav en kumulativ CR-rate på 35,4 % (67/189; 95 % CI: 28,6 % - 42,7 %).
English: Adult patients with Eastern Cooperative Oncology Group (ECOG) performance status at baseline of 2 experienced a higher incidence of serious infections compared to patients with ECOG performance status of < 2.
Danish: Voksne patienter med ECOG-status 2 (præstationsstatus ifølge Eastern Cooperative Oncology Group) ved baseline havde øget forekomst af alvorlige infektioner sammenlignet med patienter med ECOG-status < 2.
English: AlloHSCT = allogeneic haematopoietic stem cell transplantation SOC = standard of care
Danish: Allo-HSCT = allogen hæmatopoietisk stamcelletransplantation SB = standardbehandling
English: A single cycle of treatment is 28 days (4 weeks) of continuous infusion.
Danish: En enkelt behandlingscyklus består af 28 dages (4 ugers) kontinuerlig infusion.
English: The patient (including caregivers) educational material should contain: The patient information guide, including the following key elements:
Danish: Undervisningsmaterialet til patienten (inklusive omsorgspersoner) skal indeholde: Patientvejledningen, der indeholder følgende nøgleelementer:
English: Escalate to 15 mcg/m2/day after
Danish: Optrap til 15 mikrog/m2/dag efter
English: The adverse reactions described in this section were identified in clinical studies of patients with B-precursor ALL (N = 843).
Danish: De bivirkninger, der er beskrevet i dette afsnit, er identificeret i kliniske studier hos patienter med B-prækursor ALL (N = 843).
English: In clinical studies, patients with moderate renal impairment showed an increased incidence of TLS compared with patients with mild renal impairment or normal renal function.
Danish: I kliniske studier udviste patienter med moderat nyresvækkelse øget forekomst af TLS sammenlignet med patienter med mild nyresvækkelse eller normal nyrefunktion.
English: This medicinal product provides less than 1 mmol (23 mg) sodium over a 24 hour infusion i.e. “essentially sodium-free”.
Danish: Dette lægemiddel giver mindre end 1 mmol natrium (23 mg) i løbet af en 24 timers infusion, dvs. at det stort set er ”natriumfrit”.
English: Blinatumomab mediates the formation of a cytolytic synapse between the T-cell and the tumour cell, releasing proteolytic enzymes to kill both proliferating and resting target cells.
Danish: Blinatumomab formidler dannelsen af en cytolytisk synapse mellem T-cellen og tumorcellen og frigiver derved proteolytiske enzymer, der dræber både prolifererende og hvilende målceller.
English: Two subjects achieved a complete MRD response with 1 additional cycle of BLINCYTO.
Danish: To patienter opnåede komplet MRD-respons med 1 yderligere cyklus af BLINCYTO.
English: 3 patients < 1 year of age refractory to prior treatment and without prior alloHSCT received one cycle of Blincyto at a dose of 5-15 µg/m2/day.
Danish: 3 patienter < 1 år, som var refraktære over for tidligere behandling og ikke havde fået allo-HSCT, fik én cyklus med Blincyto med en dosis på 5-15 mikrog/m2/dag.
English: Thirty-two of 189 (17%) patients underwent allogeneic HSCT in CR/CRh* induced with BLINCYTO (see table 3).
Danish: Toogtredive ud af 189 (17 %) patienter gennemgik allogen HSCT med CR/CRh* induceret med BLINCYTO (se tabel 3).
English: Store and transport refrigerated (2°C - 8°C).
Danish: Opbevares og transporteres i køleskab (2 °C - 8 °C).
English: b/CRi c, n (%) [95% CI] Treatment difference [95% CI] p-value CR, n (%) [95% CI] Treatment difference [95% CI] p-value Event-free survival d
Danish: b/CRi c, n (%) [95 % CI] Behandlingsforskel [95 % CI] p-værdi CR, n (%) [95 % CI] Behandlingsforskel [95 % CI] p-værdi Hændelsesfri overlevelse d
English: Neutropenia and febrile neutropenia, including life-threatening cases, have been observed in patients receiving BLINCYTO.
Danish: Der er observeret neutropeni og febril neutropeni, herunder livstruende tilfælde, hos patienter, der fik BLINCYTO.
English: BLINCYTO can cause neurological problems such as dizziness, seizures, confusion, coordination and balance disorders.
Danish: BLINCYTO kan forårsage neurologiske problemer såsom svimmelhed, krampeanfald og forvirring samt koordinations- og balanceforstyrrelser.
English: The MAH shall ensure that in each Member State where BLINCYTO is marketed, all healthcare professionals (HCP) and patients / caregivers who are expected to prescribe, dispense and use BLINCYTO are provided with the following educational packages:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at nedenstående undervisningsmaterialer udleveres til alt sundhedspersonale og alle patienter/omsorgspersoner, der forventes at ordinere, udlevere og anvende BLINCYTO, i hvert medlemsland, hvor BLINCYTO markedsføres:
English: Leukoencephalopathy has been reported.
Danish: Der er indberettet tilfælde af leukoencefalopati.
English: In an embryo-foetal developmental toxicity study performed in mice, the murine surrogate crossed the placenta to a limited extent (foetal-to-maternal serum concentration ratio < 1%) and did not induce embryo-foetal toxicity or teratogenicity.
Danish: I et studie af den embryoføtale udviklingstoksicitet, der blev gennemført på mus, krydsede det murine surrogat placenta i begrænset udstrækning (føtal-til-maternel serumkoncentrationsratio < 1 %) og forårsagede ikke embryo-føtal toksicitet eller teratogenicitet.
English: Table 7 provides instructions for patients weighing greater than or equal to 45 kg, whereas table 8 and table 9 provide instructions for patients weighing less than 45 kg.
Danish: Tabel 7 indeholder instruktioner for patienter, der vejer 45 kg eller derover, og tabel 8 og tabel 9 indeholder instruktioner for patienter, der vejer under 45 kg.
English: The adverse reactions in BLINCYTO-treated paediatric patients were similar in type to those seen in adult patients.
Danish: Bivirkningerne hos pædiatriske patienter behandlet med BLINCYTO svarede til dem, der blev set hos voksne patienter.
English: Blinatumomab is associated with transient upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T-cells, and results in elimination of CD19+ cells.
Danish: Blinatumomab er forbundet med forbigående opregulering af celleadhæsionsmolekyler, produktion af cytolytiske proteiner, frigivelse af inflammatoriske cytokiner og proliferation af T-celler og medfører eliminering af CD19+-celler.
English: The estimated mean (SD) volume of distribution (Vz), clearance (CL) and terminal half-life (t1/2,z) were 3.91 (3.36) L/m2, 1.88 (1.90) L/hr/m and 2.19 (1.53) hours, respectively.
Danish: Estimeret gennemsnitlig (SD) distributionsvolumen (Vz), clearance (CL) og terminal halveringstid (t1/2,z) var henholdsvis 3,91 (3,36) l/m2, 1,88 (1,90 )l/t/m og 2,19 (1,53) timer.
English: Chemical and physical in-use stability has been demonstrated for 10 days at 2°C - 8°C or 96 hours at or below 27°C.
Danish: Den kemiske og fysiske stabilitet efter åbning er påvist i 10 dage ved 2 °C - 8 °C eller 96 timer ved maksimalt 27 °C.
English: Medication errors have been observed with BLINCYTO treatment.
Danish: Der er set medicineringsfejl i forbindelse med behandling med BLINCYTO.
English: RFS in patients with Philadelphia chromosome negative B-precursor ALL at 18 months censored at HSCT or postBLINCYTO chemotherapy was 54% (33%, 70%).
Danish: RFS hos patienter med Philadelphia-kromosom-negativ B-prækursor ALL ved 18 måneder censureret ved HSCT eller post-BLINCYTO kemoterapi var 54 % (33 %, 70 %).
English: Visually inspect the reconstituted solution for particulate matter and discolouration during reconstitution and prior to infusion.
Danish: Kontrollér den rekonstituerede opløsning visuelt for partikler og misfarvning under rekonstitution og inden infusion.
English: Patients should be closely monitored for signs and symptoms of pancreatitis.
Danish: Patienterne skal monitoreres nøje for tegn og symptomer på pancreatitis.
English: GRH0358 v1
Danish: GRH0508DA v1
English: You must not breast-feed during and for at least 48 hours after your last treatment.
Danish: Du må ikke amme under behandlingen og i mindst 48 timer efter din sidste behandling.
English: Days 8-28 Days 29-42 Days 1-28 Days 29-42
Danish: Dag 8-28 Dag 29-42 Dag 1-28 Dag 29-42
English: From a microbiological point of view, unless the method of reconstituting precludes the risks of microbial contamination, the reconstituted solution should be diluted immediately.
Danish: Fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning bruges med det samme, medmindre den metode, der er anvendt til rekonstituering, udelukker risikoen for mikrobiel kontaminering.
English: Hyperbilirubinaemia a,
Danish: Hyperbilirubinæmi a, 10
English: Cytokine release syndrome (CRS)
Danish: Cytokinfrigivelsessyndrom (CRS)
English: No anti-blinatumomab antibodies were detected in clinical studies of paediatric patients with relapsed or refractory ALL treated with blinatumomab.
Danish: Der blev ikke påvist nogen anti-blinatumomab-antistoffer i kliniske studier af pædiatriske patienter med recidiveret eller refraktær ALL, som fik behandling med blinatumomab.
English: • reactions related to infusion may include face swelling, low blood pressure, high blood pressure (infusion-related reaction)
Danish: • reaktioner i forbindelse med infusionen, som kan omfatte ansigtshævelse, lavt blodtryk, forhøjet blodtryk (infusionsrelateret reaktion)
English: (see section 5.1).
Danish: (angivet i afsnit 6).