FrancophonIA/ELRC3.0 huggingface dataset:
English: Laboratory parameters (including, but not limited to white blood cell count and absolute neutrophil count) should be monitored routinely during BLINCYTO infusion, especially during the first 9 days of the first cycle, and treated appropriately.
Danish: Laboratorieparametre (herunder, men ikke begrænset til antal hvide blodlegemer og absolutte neutrofiler) bør kontrolleres regelmæssigt under infusionen af BLINCYTO, især i de første 9 dage af den første cyklus, og behandles om nødvendigt.
English: EFS time was calculated from the time of randomisation until the date of disease assessment indicating a relapse after achieving a CR/CRh*/CRi or death, whichever is earlier.
Danish: d. EFS-tid blev beregnet ud fra tidspunkt for randomisering indtil dato for sygdomsvurdering, der viste recidiv efter at have opnået CR/CRh*/CRi eller dødsfald (førstkommende af hændelserne).
English: The primary endpoint was the proportion of patients who achieved a complete MRD response within one cycle of BLINCYTO treatment.
Danish: Det primære endemål var andelen af patienter, som opnåede komplet MRD-respons inden for én cyklus af BLINCYTO-behandling.
English: Overdoses resulted in adverse reactions which were consistent with the reactions observed at the recommended therapeutic dose and included fever, tremors, and headache.
Danish: Overdoseringerne medførte bivirkninger, som svarede til dem, der observeres ved den anbefalede terapeutiske dosis, og omfattede feber, tremor og hovedpine.
English: During the continuous intravenous infusion over 4 weeks, the pharmacodynamic response was characterised by T-cell activation and initial redistribution, rapid peripheral B-cell depletion, and transient cytokine elevation.
Danish: I løbet af den kontinuerlige intravenøse infusion over 4 uger var den farmakodynamiske respons kendetegnet ved T-celle-aktivering og indledende redistribution, hurtig depletering af perifere B-celler samt en forbigående stigning i cytokiner.
English: Like other protein therapeutics, blinatumomab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Danish: Blinatumomab forventes på samme måde som andre terapeutiske proteiner at blive nedbrudt til små peptider og aminosyrer via katabolske veje.
English: Among these patients, the median time to the first neurologic event was within the first cycle of treatment.
Danish: Hos disse patienter var mediantiden til den første neurologiske hændelse inden for den første behandlingscyklus.
English: Before each infusion cycle of BLINCYTO, you will be given medicines which help reduce a potentially life-threatening complication known as tumour lysis syndrome, which is caused by chemical disturbances in the blood due to the breakdown of dying cancer cells.
Danish: Inden hver infusionscyklus af BLINCYTO vil du få lægemidler, der er med til at forebygge en potentielt livstruende komplikation, der hedder tumorlysesyndrom, og som skyldes kemiske forstyrrelser i blodet som følge af nedbrydningen af døende kræftceller.
English: Do not use if the solution is cloudy or has precipitated.
Danish: Må ikke bruges, hvis opløsningen er grumset eller har bundfældet sig.
English: The majority of the events were observed within the first week of treatment initiation and did not require interruption or discontinuation of BLINCYTO (see section 4.8).
Danish: Størstedelen af hændelserne blev observeret inden for den første uge efter behandlingens start og krævede ikke afbrydelse eller seponering af BLINCYTO (se pkt.
English: The nurse educational material should contain:
Danish: Undervisningsmaterialet til sygeplejersker skal indeholde:
English: • 1 glass vial containing a white to off-white powder.
Danish: • 1 hætteglas, der indeholder et hvidt til off-white pulver.
English: Eleven of the 20 patients (55%) who achieved CR/CRh* received an allogeneic HSCT.
Danish: Elleve af de 20 patienter (55 %), som opnåede CR/CRh*, fik en allogen HSCT.
English: BLINCYTO will be given to you through a vein (intravenous) continuously for 4 weeks using an infusion pump (this is 1 treatment cycle).
Danish: Du vil få BLINCYTO gennem en vene (intravenøst) kontinuerligt i 4 uger med anvendelse af en infusionspumpe (dette udgør 1 behandlingscyklus).
English: c. Complete MRD response No detectable signal for leukemic cells either by PCR or flow cytometry.
Danish: c. Komplet MRD-respons: intet påviseligt signal for leukæmiske celler med enten PCR-metode eller flowcytometri.
English: Consistent immune-pharmacodynamic responses were observed in patients studied.
Danish: Der blev observeret konsekvente immunologiske farmakodynamiske responser hos de undersøgte patienter.
English: Elderly patients with MRD-positive ALL treated with BLINCYTO may have an increased risk of hypogammaglobulinaemia compared to younger patients.
Danish: Ældre patienter med MRD-positiv ALL, som behandles med BLINCYTO, kan have forhøjet risiko for hypogammaglobulinæmi sammenlignet med yngre patienter.
English: Tell your doctor, pharmacist or nurse immediately if you experience any of the following reactions whilst receiving BLINCYTO as these may need to be treated and your dose adjusted:
Danish: Fortæl det straks til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får en eller flere af nedenstående reaktioner, mens du behandles med BLINCYTO, da sådanne reaktioner muligvis skal behandles, og din dosis justeres:
English: Consolidation Cycles 2-4 Days 1-28
Danish: Konsolideringscyklusser 2-4 Dag 1-28
English: Peripheral lymphocytes were not measured in paediatric subjects.
Danish: Perifere lymfocytter blev ikke målt hos pædiatriske patienter.
English: The median time to the first event was within the first two weeks of treatment.
Danish: Mediantiden indtil første bivirkning var inden for de første to uger af behandlingen.
English: • high blood pressure (hypertension)
Danish: • forhøjet blodtryk (hypertension)
English: RFS at 18 months not censored at HSCT or postBLINCYTO chemotherapy was 53% (44%, 62%).
Danish: RFS ved 18 måneder ikkecensureret ved HSCT eller post-BLINCYTO kemoterapi var 53 % (44 %, 62 %).
English: Four patients achieved M1 bone marrow but did not meet the peripheral blood count recovery criteria for CR or CRh*.
Danish: Fire patienter opnåede M1-knoglemarv, men opfyldt ikke kriterierne for genoprettelse af perifere blodtal for CR eller CRh*.
English: MRD positive B-precursor ALL
Danish: MRD-positiv B-prækursor ALL
English: • Description of the main signs and / or symptoms of neurologic events and the importance of notifying the treating physician or nurse immediately if symptoms occur
Danish: • Beskrivelse af de vigtigste tegn og/eller symptomer på neurologiske hændelser og af betydningen af, at den behandlende læge/sygeplejersken straks informeres, hvis der opstår symptomer
English: Your infusion catheter will be attached to you at all times during each cycle of your treatment.
Danish: Dit infusionskateter vil være påsat hele tiden under forløbet af hver cyklus i behandlingen.
English: Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agents, ATC code: L01XC19.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler - andre antineoplastiske midler, ATC-kode: L01XC19
English: Median OS, mo
Danish: Median-OS, mdr.
English: Each pack of BLINCYTO contains:
Danish: Hver BLINCYTO-pakning indeholder:
English: (not to exceed 20 mg) should be administered orally or intravenously 6 to 12 hours prior to the start of BLINCYTO (cycle 1, day 1).
Danish: (må ikke overskride 20 mg) administreres oralt eller intravenøst 6 til 12 timer inden påbegyndelse af BLINCYTO (cyklus 1, dag 1).
English: Infusion rate (mL/hour)
Danish: Infusionshastighed (ml/time)
English: • Detailed description of the reconstitution and preparation procedures of BLINCYTO infusion solution for intravenous administration under aseptic conditions, using aseptic techniques.
Danish: • Detaljeret beskrivelse af procedurerne for rekonstitution og klargøring af BLINCYTO infusionsvæske til intravenøs administration under aseptiske betingelser og med anvendelse af aseptiske teknikker
English: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO treatment, during treatment, and until recovery of B-lymphocytes to normal ranges following last treatment cycle.
Danish: Vaccination med levende virusvacciner anbefales ikke i mindst 2 uger, inden behandling med BLINCYTO starter, under behandlingen, og indtil B-lymfocytterne er vendt tilbage til de normale værdier efter den sidste behandlingscyklus.
English: • Store the package at room temperature (up to 27°C).
Danish: • Du skal opbevare pakningen ved stuetemperatur (op til 27 °C).
English: There is limited experience with BLINCYTO in patients with an active uncontrolled infection.
Danish: Der er begrænset erfaring med anvendelse af BLINCYTO til patienter med en aktiv, ukontrolleret infektion.
English: Each cycle of treatment is separated by a 14 day (2 week) treatment-free interval.
Danish: Hver behandlingscyklus er adskilt af et 14 dages (2 ugers) behandlingsfrit interval.
English: Alternatively the vials can be stored at room temperature (up to 27°C) for up to 4 hours.
Danish: Alternativt kan hætteglassene opbevares ved stuetemperatur (op til 27 °C) i op til 4 timer.
English: Among patients that experienced a neurologic event, the median time to the first event was within the first two weeks of treatment and the majority of events resolved after treatment interruption and infrequently led to BLINCYTO treatment discontinuation.
Danish: Blandt patienter, der havde en neurologisk hændelse, var mediantiden indtil første hændelse inden for to ugers behandling, og størstedelen af hændelserne forsvandt efter afbrydelse af behandlingen og førte sjældent til seponering af behandlingen med BLINCYTO.
English: Your doctor may need to take special care of you during your treatment with BLINCYTO.
Danish: Lægen vil muligvis skulle tage sig særligt af dig under din behandling med BLINCYTO.
English: a Complete MRD response was defined as the absence of detectable MRD confirmed in an assay with minimum sensitivity of 10-4 b One hundred thirteen patients (97.4%; 113/116) were included in the primary endpoint full analysis set
Danish: a Komplet MRD-respons blev defineret som fravær af påviselig MRD bekræftet i en analyse med minimumssensitivitet på 10-4 b Et hundrede og tretten patienter (97,4 %; 113/116) blev inkluderet i det fulde analysesæt for det primære endemål
English: Insomnia
Danish: Insomni
English: - The active substance is blinatumomab.
Danish: - Aktivt stof: blinatumomab.
English: Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures.
Danish: En evaluering af patienterne kan omfatte en objektiv undersøgelse, laboratorieprøver til serumamylase og serumlipase samt abdominal billeddiagnostik, for eksempel ultralyd og andre egnede diagnostiske tiltag.
English: Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet efter, hvor alvorlige de er.
English: It is not known whether BLINCYTO is excreted in breast milk but a risk for suckling baby cannot be excluded.
Danish: Det er ukendt, om BLINCYTO udskilles i human mælk, men en risiko for det diende barn kan ikke udelukkes.
English: Subjects who fail to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation are considered treatment failures and assigned an EFS duration of 1 day.
Danish: For patienter, der ikke opnår CR/CRh*/CRi inden for 12 uger efter initiering af behandlingen, anses behandlingen for at have fejlet, og disse patienter tildeles en EFS-varighed på 1 dag.
English: The patient alert card should contain:
Danish: Patientkortet skal indeholde:
English: • lung infection (pneumonia)
Danish: • lungebetændelse (pneumoni)
English: BLINCYTO contains sodium
Danish: BLINCYTO indeholder natrium
English: Hypotension includes blood pressure decreased and hypotension.
Danish: Hypotension omfatter nedsat blodtryk og hypotension.
English: Patients received up to 4 cycles of treatment.
Danish: Patienterne fik op til 4 behandlingscyklusser.
English: Treatment cycle(s)
Danish: Behandlingscyklus(ser)
English: • a condition which causes fluid to leak from the small blood vessels into your body (capillary leak syndrome)
Danish: • en tilstand, der får væske fra de små blodkar til at sive ind i kroppen (kapillær lækage-syndrom)
English: Body surface area (0.37 to 2.70 m2) influences the pharmacokinetics of blinatumomab.
Danish: Legemsoverfladeareal (0,37 til 2,70 m2) påvirker blinatumomabs farmakokinetik.
English: Weight increased Blood alkaline phosphatase increased
Danish: Vægtstigning Forhøjet alkalisk phosphatase i blodet
English: Store and transport refrigerated.
Danish: Opbevares og transporteres i køleskab.
English: Randomisation was stratified by age (< 35 years versus ≥ 35 years of age), prior salvage therapy (yes versus no), and prior allogeneic HSCT (yes versus no) as assessed at the time of consent.
Danish: Randomiseringen var stratificeret efter alder (< 35 år vs. ≥ 35 år), tidligere livreddende behandling (ja vs. nej) og tidligere allogen HSCT (ja vs. nej), vurderet på tidspunktet for samtykke.
English: 9 Hypertension includes blood pressure increased and hypertension.
Danish: 9 Hypertension omfatter stigning i blodtryk og hypertension.
English: Most patients had a high tumour burden (≥ 50% leukaemic blasts in bone marrow) at baseline with a median of 75.5% bone marrow blasts.
Danish: De fleste patienter havde en høj tumorbyrde (≥ 50 % leukæmiske blastceller i knoglemarv) ved baseline, med en median på 75,5 % knoglemarvsblastceller.
English: • headache, shaking (or tremor)
Danish: • hovedpine, rysten (tremor)
English: Patients may receive 1 cycle of induction treatment followed by up to 3 additional cycles of BLINCYTO consolidation treatment.
Danish: Patienterne kan få 1 cyklus som induktionsbehandling efterfulgt af op til 3 yderligere cyklusser af BLINCYTO som konsolideringsbehandling.
English: Infuse BLINCYTO solution according to the instructions on the pharmacy label on the prepared bag at one of the following constant infusion rates:
Danish: Infunder BLINCYTO-opløsningen i henhold til instruktionerne på apoteksetiketten på den klargjorte pose med en af følgende konstante infusionshastigheder:
English: The estimated mean (SD) volume of distribution based on terminal phase (Vz) was 4.52 (2.89) L with the continuous intravenous infusion of blinatumomab.
Danish: Den estimerede gennemsnitlige (SD) distributionsvolumen, baseret på terminal fase (Vz), var 4,52 (2,89) l ved kontinuerlig intravenøs infusion af blinatumomab.
English: Patients must be advised that they may experience neurologic events.
Danish: Patienterne skal informeres om, at de kan få neurologiske bivirkninger.
English: • Recommendation to monitor patients for signs and symptoms of neurotoxicity
Danish: • Anbefaling af at monitorere patienterne for tegn og symptomer på neurotoksicitet
English: In clinical studies of adult ALL patients treated with BLINCYTO, less than 3% tested positive for anti-blinatumomab antibodies.
Danish: I kliniske studier med voksne ALL-patienter, der blev behandlet med BLINCYTO, blev under 3 % testet positive for anti-blinatumomab-antistoffer.
English: HR (BLINCYTO/SOC Chemo) (95% CI) p-value (2-sided)
Danish: HR (BLINCYTO/SB kemo) (95 % CI) p-værdi (2-sidet)
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. at det stort set er ”natriumfrit”.
English: Population pharmacokinetic analysis suggested that there was no association between ALT or AST levels and the clearance of blinatumomab.
Danish: En farmakokinetisk populationsanalyse tydede på, at der ikke er nogen forbindelse mellem ALAT- eller ASAT-niveauerne og blinatumomabs clearance.
English: • Water for injections
Danish: • Vand til injektionsvæsker.
English: Medication errors
Danish: Medicineringsfejl
English: • increased levels of liver enzymes (ALT, AST, GGT)
Danish: • forhøjede niveauer af leverenzymer (ALAT, ASAT, GGT)
English: Patients who are receiving medicinal products that are CYP450 and transporter substrates with a narrow therapeutic index should be monitored for adverse effects (e.g. warfarin) or drug concentrations (e.g. cyclosporine) during this time.
Danish: Patienter, der får lægemidler, som er CYP450- og transportsubstrater med et smalt terapeutisk indeks, bør monitoreres for bivirkninger (fx warfarin) eller lægemiddelkoncentrationer (fx cyclosporin) i dette tidsrum.
English: Appropriate prophylactic measures including aggressive hydration and anti-hyperuricaemic therapy (such as allopurinol or rasburicase) should be used for the prevention and treatment of TLS during BLINCYTO treatment, especially in patients with higher leukocytosis or a high tumour burden.
Danish: Der bør træffes passende profylaktiske foranstaltninger, herunder intensiv hydrering og antihyperurikæmisk behandling (såsom allopurinol eller rasburicase), til forebyggelse og behandling af TLS under behandling med BLINCYTO - især hos patienter med højere leukocytose eller stor tumorbyrde.
English: Intrathecal chemotherapy prophylaxis is recommended before and during BLINCYTO therapy to prevent central nervous system ALL relapse.
Danish: Intratekal kemoterapeutisk profylakse anbefales inden og under behandling med BLINCYTO for at forebygge ALL-recidiv i centralnervesystemet.
English: Negligible amounts of blinatumomab were excreted in the urine at the tested clinical doses.
Danish: Ubetydelige mængder blinatumomab blev udskilt i urin ved de afprøvede kliniske doser.
English: - Once at room temperature (up to 27°C) the solution will be infused within 96 hours.
Danish: - Når opløsningen har opnået stuetemperatur (op til 27 °C), vil den blive givet som infusion inden for 96 timer.
English: BLINCYTO is used to treat adults with acute lymphoblastic leukaemia.
Danish: BLINCYTO bruges til behandling af voksne med akut lymfoblastisk leukæmi.
English: Peripheral T-cell redistribution (i.e. T-cell adhesion to blood vessel endothelium and/or transmigration into tissue) occurred after start of blinatumomab infusion or dose escalation.
Danish: Redistributionen af perifere T-celler (dvs. T-cellers adhæsion til blodkars endotel og/eller transmigration til væv) opstod efter start af infusionen af blinatumomab eller dosiseskalering.
English: Premedication and additional medication recommendations
Danish: Præmedicinering og anbefalinger til anden medicinering
English: Serious and grade ≥ 3 neurologic adverse reactions were observed in 11.6% and 12.1% of patients respectively, of which the most common serious adverse reactions were encephalopathy, tremor, aphasia, and confusional state.
Danish: Der blev observeret alvorlige og grad ≥ 3 neurologiske bivirkninger hos henholdsvis 11,6 % og 12,1 % af patienterne, hvoraf de fleste alvorlige bivirkninger var encefalopati, tremor, afasi og konfusion.
English: 0/12, 0.0% (0.0, NE)
Danish: 0/12; 0,0 % (0,0; kan ikke estimeres)
English: • nerve problems affecting the head and neck such as visual disturbances, drooping eyelid and/or sagging muscles on one side of the face, difficulty hearing or trouble swallowing
Danish: • nerveproblemer, der rammer hoved og nakke, såsom synsforstyrrelser, hængende øjenlåg og/eller hængende muskler i den ene side af ansigtet, problemer med at høre eller synke
English: It activates endogenous T-cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B-cells.
Danish: Det aktiverer endogene T-celler ved at forbinde CD3 i T-celle-receptorkomplekset (TCR-komplekset) med CD19 på benigne og maligne B-celler.
English: 96 hours
Danish: 96 timer
English: The duration of hepatic adverse reactions has generally been brief and with rapid resolution, often when continuing uninterrupted treatment with BLINCYTO.
Danish: Varigheden af leverbivirkningerne har generelt været kort, og de er forsvundet hurtigt - ofte efter fortsat behandling med BLINCYTO uden afbrydelser.
English: Escalate to 28 mcg/day after 7 days if the toxicity does not recur.
Danish: Optrap til 28 mikrog/dag efter 7 dage, hvis toksiciteten ikke vender tilbage.
English: Median overall survival [95% CI]
Danish: Median samlet overlevelse [95 % CI]
English: There is limited experience with blinatumomab in patients with documented active ALL in the CNS or cerebrospinal fluid (CSF).
Danish: Der er begrænset erfaring med anvendelse af blinatumomab til patienter med dokumenteret aktiv ALL i CNS eller cerebrospinalvæske (CSV).
English: The recommended dose of BLINCYTO throughout each 4-week treatment cycle is 28 mcg/day.
Danish: Den anbefalede dosis af BLINCYTO i hver 4-ugers behandlingscyklus er 28 mikrog/dag.
English: Greater than or equal to 45 kg (fixed-dose)
Danish: Over eller lig med 45 kg (fast dosis)
English: • Data from clinical trials, causes of ME, frequency, severity and outcomes.
Danish: • Data fra kliniske forsøg, årsager til medicineringsfejl, hyppighed, sværhedsgrad og udfald
English: The primary endpoint was the complete remission/complete remission with partial haematological recovery (CR/CRh*) rate within 2 cycles of treatment with BLINCYTO.
Danish: Det primære endemål var raten for komplet remission/komplet remission med delvis hæmatologisk genoprettelse (CR/CRh*-raten) inden for 2 cyklusser med behandling med BLINCYTO.
English: Sodium hydroxide (for pH-adjustment) Water for injections
Danish: Natriumhydroxid (til justering af pH) Vand til injektionsvæsker
English: Your doctor or nurse will show you how to care for your catheter site.
Danish: Lægen eller sygeplejersken vil vise dig, hvordan du skal passe og pleje området omkring kateteret.
English: [4.8 to 8.3 months]
Danish: [4,8 til 8,3 mdr.]
English: 3.8 months (1.9, 19.0)
Danish: 3,8 måneder (1,9; 19,0)
English: There is limited data in patients with late first relapse of B-precursor ALL defined as a relapse occurring more than 12 months after first remission or more than 12 months after HSCT in the first remission.
Danish: Der findes kun begrænsede data fra patienter med sent første recidiv af B-prækursor ALL, defineret som et recidiv, der forekommer mere end 12 måneder efter første remission eller mere end 12 måneder efter HSCT i den første remission.
English: In a prespecified exploratory analysis, 60 of 73 MRD evaluable patients with CR/CRh* (82.2%) also had a MRD response (defined as MRD by PCR < 1 x 10
Danish: I en præspecificeret eksploratorisk analyse havde 60 ud af 73 MRD-evaluerbare patienter med CR/CRh* (82,2 %) også MRD-respons (defineret som MRD ved PCR-metode på < 1 x 10
English: [4.2 to 7.5 months]
Danish: [4,2 til 7,5 mdr.]
English: Blinatumomab has major influence on the ability to drive and use machines.
Danish: Blinatumomab påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Treatment may include a bag change by a nurse.
Danish: Behandlingen kan omfatte, at en sygeplejerske skal skifte infusionsposen.
English: If your body weight is less than 45 kilograms, the recommended initial dose in your first cycle will be based on your weight and height.
Danish: Hvis du vejer under 45 kg, vil den anbefalede startdosis i din første cyklus være baseret på din vægt og højde.
English: Patients greater than or equal to 45 kg receive a fixed-dose and for patients less than 45 kg, the dose is calculated using the patient's body surface area (BSA).
Danish: Patienter, der vejer 45 kg eller derover, får en fast dosis, og for patienter, der vejer under 45 kg, udregnes dosis efter patientens legemsoverfladeareal (BSA).
English: The majority of patients who respond to blinatumomab achieve a response after 1 cycle (see section 5.1).
Danish: Størstedelen af de patienter, som reagerer på blinatumomab, opnår respons efter 1 cyklus (se pkt.
English: • excessive activation of white blood cells associated with inflammation (hemophagocytic histiocytosis)
Danish: • kraftig aktivering af hvide blodlegemer, der er forbundet med betændelse (hæmofagocytisk histiocytose)