FrancophonIA/ELRC3.0 huggingface dataset:
English: Life-threatening or fatal (grade ≥ 4) viral, bacterial and fungal infections have been reported in patients treated with BLINCYTO.
Danish: Der er indberettet livstruende eller fatale (grad ≥ 4) virale og bakterielle infektioner og svampeinfektioner hos patienter, der blev behandlet med BLINCYTO.
English: Efficacy results in patients ≥ 18 years of age with MRD positive B-precursor ALL
Danish: Effektresultater hos patienter ≥ 18 år med MRD-positiv B-prækursor ALL
English: If you have minimal residual disease acute lymphoblastic leukaemia, it is recommended that the first 3 days of treatment and the first 2 days of subsequent cycles will be given to you in a hospital or clinic under the supervision of a doctor or nurse experienced in the use of anti-cancer medicines.
Danish: Hvis du har minimal residual sygdom i forbindelse med akut lymfoblastisk leukæmi, anbefales det, at du er indlagt på hospitalet eller en klinik i de første 3 dage med behandling og i de første 2 dage af efterfølgende cyklusser under opsyn af en læge eller sygeplejerske, som har erfaring med anvendelse af kræftmedicin.
English: If you are still suffering from active neurological problems or conditions, tell your doctor.
Danish: Fortæl det til din læge, hvis du stadig har aktive neurologiske problemer eller tilstande.
English: Convulsion Discontinue BLINCYTO permanently if more than one convulsion occurs.
Danish: Krampeanfald Seponér BLINCYTO permanent, hvis der er mere end ét krampeanfald.
English: Back pain Pain in extremity
Danish: Rygsmerter Smerter i ekstremitet
English: Using a syringe, aseptically transfer reconstituted BLINCYTO into the infusion bag (refer to table 7 to table 9 for the specific volume of reconstituted BLINCYTO).
Danish: Overfør rekonstitueret BLINCYTO aseptisk til infusionsposen med anvendelse af en sprøjte (se tabel 7 til tabel 9 for den nøjagtige volumen af rekonstitueret BLINCYTO).
English: BLINCYTO solution for infusion is administered as a continuous intravenous infusion delivered at a constant flow rate using an infusion pump over a period of up to 96 hours.
Danish: BLINCYTO infusionsvæske, opløsning, administreres som en kontinuerlig intravenøs infusion, der tilføres med en konstant flow hastighed med anvendelse af en infusionspumpe i et tidsrum på op til 96 timer.
English: • 1 glass vial containing a colourless-to-slightly yellow, clear solution.
Danish: • 1 hætteglas, der indeholder en farveløs til lysegul, klar opløsning.
English: Uncommon (≥ 1/1,000 to < 1/100)
Danish: Ikke almindelig (≥ 1/1.000 til
English: • if you develop a reaction at any time during your infusion, which may include dizziness, feeling faint, nauseated, face swelling, difficulty breathing, wheezing, or rash.
Danish: • Hvis du får en reaktion når som helst under infusionen, som kan være i form af svimmelhed, ørhed, kvalme, ansigtshævelse, vejrtrækningsbesvær, hvæsende vejrtrækning eller udslæt.
English: Grade 3 and serious events were reported for 1.5% each of adult patients with MRD positive B-precursor ALL; no grade ≥ 4 events were reported.
Danish: Både grad 3 og alvorlige hændelser blev rapporteret for 1,5 % af voksne patienter med MRD-positiv B-prækursor ALL; der blev ikke rapporteret nogen grad ≥ 4-hændelser.
English: Gently swirl contents to avoid excess foaming.
Danish: Skvulp indholdet forsigtigt for at undgå dannelse af skum.
English: • chills, shivering, fever, rapid heart rate, decreased blood pressure, aching muscles, feeling tired, coughing, difficulty breathing, confusion, redness, swelling or discharge in the affected area or at the site of the infusion line - these may be signs of an infection.
Danish: • kulderystelser, kuldegysninger, feber, hurtig hjerterytme, nedsat blodtryk, muskelømhed, træthed, hoste, vejrtrækningsbesvær, forvirring, rødmen, hævelse eller udflåd på det berørte område eller på stedet, hvor infusionsslangen sidder.
English: IV after reconstitution and dilution
Danish: efter rekonstitution og fortynding
English: Other medicines and BLINCYTO
Danish: Brug af anden medicin sammen med BLINCYTO
English: Eighty-one of 189 (42.9%) patients achieved CR/CRh* within the first 2 treatment cycles with the majority of responses (64 of 81) occurring within 1 cycle of treatment.
Danish: Enogfirs ud af 189 (42,9 %) patienter opnåede CR/CRh* inden for de første to behandlingscyklusser, hvoraf størstedelen af responserne (64 ud af 81) opstod inden for den første behandlingscyklus.
English: • Reminder to counsel the patients on how to reduce the risk of ME while using the infusion pump.
Danish: • Påmindelse om at rådgive patienterne om, hvordan man reducerer risikoen for medicineringsfejl, når infusionspumpen anvendes Neurologiske hændelser
English: No adverse effects on male or female mouse reproductive organs in 13 week toxicity studies with the murine surrogate molecule (see section 5.3).
Danish: Der var ingen bivirkninger på forplantningsorganerne hos han- eller hunmus i 13-ugers toksicitetsstudier med det murine surrogat-molekyle (se pkt.
English: Reconstitution and preparation of BLINCYTO solution for infusion using an infusion bag pre-filled with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection
Danish: Rekonstitution og klargøring af BLINCYTO infusionsvæske, opløsning, med anvendelse af en infusionspose, der er fyldt med 250 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning
English: Decreased immunoglobulins includes blood immunoglobulin G decreased, globulins decreased, hypogammaglobulinaemia, hypoglobulinaemia and immunoglobulins decreased.
Danish: 16 Fald i immunglobuliner omfatter fald i immunglobulin G i blodet, fald i globuliner, hypogammaglobulinæmi,
English: For clinical management of neurologic events, see section 4.4.
Danish: 4.4 vedrørende den kliniske behandling af neurologiske hændelser.
English: In the randomised, open-label, multicentre, phase III study, 70% (7/10) of post-transplant patients in late first relapse treated with BLINCYTO compared to 20% (1/5) treated with SOC chemotherapy achieved CR/CRh* within the first 2 treatment cycles.
Danish: I det randomiserede, åbne fase III-multicenterstudie opnåede 70 % (7/10) af post-transplantationspatienter med sen første recidiv, som blev behandlet med BLINCYTO, CR/CRh* inden for de første 2 behandlingscyklusser sammenlignet med 20 % (1/5), der blev behandlet med SB kemoterapi.
English: 3.7 months (3.0, 5.3) (N = 65)
Danish: 3,7 måneder (3,0; 5,3) (N = 65)
English: Using a syringe, aseptically transfer reconstituted BLINCYTO into the infusion bag (refer to table 1 to table 3 for the specific volume of reconstituted BLINCYTO).
Danish: Overfør rekonstitueret BLINCYTO aseptisk til infusionsposen med anvendelse af en sprøjte (se tabel 1 til tabel 3 for den nøjagtige volumen af rekonstitueret BLINCYTO).
English: The mortality rate following alloHSCT among all responders who did not receive anti-leukemic therapy was 10/38 (26.3%; 95% CI: 13.4, 43.1) in the BLINCYTO group and 3/12 (25%; 95% CI: 5.5, 57.2) in the SOC group; such mortality rate at 100 days post alloHSCT was 4/38 (12.4%; 95% CI: 4.8%, 29.9%) in the BLINCYTO group and 0/12 (0%; 95% CI: not estimable) in the SOC group.
Danish: Mortalitetsraten efter allo-HSCT blandt alle respondenter, der ikke fik behandling mod leukæmi, var 10/38 (26,3 %; 95 % CI: 13,4; 43,1) i BLINCYTO-gruppen og 3/12 (25 %, 95 % CI: 5,5; 57,2) i SB-gruppen; en sådan mortalitetsrate 100 dage efter allo-HSCT var 4/38 (12,4 %; 95 % CI: 4,8 %; 29,9 %) i BLINCYTO-gruppen og 0/12 (0 %; 95 % CI: kan ikke estimeres) i SB-gruppen.
English: e. Relapse was defined as haematological relapse (blasts in bone marrow greater than 25% following CR) or an extramedullary relapse.
Danish: e. Recidiv blev defineret som et hæmatologisk recidiv (blastceller i knoglemarv på over 25 % efter CR) eller et ekstramedullært recidiv.
English: • A solution (stabiliser) is provided inside the BLINCYTO package and is used to coat the pre-filled infusion bag prior to addition of reconstituted BLINCYTO.
Danish: • En opløsning (stabilisator) leveres med (inde i) BLINCYTO-pakningen og bruges til overfladebehandling af den fyldte infusionspose inden tilsætning af det rekonstituerede BLINCYTO.
English: Twenty out of 70 (28.6%) patients achieved CR/CRh* within the first 2 treatment cycles with 17 out of 20 (85%) occurring within cycle 1 of treatment.
Danish: Tyve ud af 70 (28,6 %) patienter opnåede CR/CRh* inden for de første 2 behandlingscyklusser, og af disse forekom 17 ud af 20 (85 %) inden for den første behandlingscyklus.
English: Treatment with BLINCYTO was associated with transient elevations in liver enzymes.
Danish: Behandling med BLINCYTO var forbundet med forbigående stigninger i leverenzymer.
English: tumour lysis syndrome, neurological toxicity, elevated liver enzymes and any other clinically relevant toxicities.
Danish: 4.4): cytokinfrigivelsessyndrom, tumorlysesyndrom, neurologisk toksicitet, forhøjede leverenzymer og andre klinisk relevante toksiciteter.
English: CR Duration of complete MRD response [95% CI]
Danish: Varighed af komplet MRD-respons [95% CI]
English: Symptoms may include wheezing, flushing, face swelling, difficulty breathing, low or high blood pressure.
Danish: Symptomerne kan være hvæsende vejrtrækning, rødmen, ansigtshævelse, vejrtrækningsbesvær, nedsat eller forhøjet blodtryk.
English: However, elderly patients may be more susceptible to serious neurologic events such as cognitive disorder, encephalopathy and confusion.
Danish: Ældre patienter kan dog være mere modtagelige over for alvorlige neurologiske hændelser såsom kognitive lidelser, encefalopati og konfusion.
English: Cytokine release syndrome a
Danish: Cytokinfrigivelsessyndrom a
English: Talk to your doctor, pharmacist or nurse before using BLINCYTO if any of these apply to you.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger BLINCYTO, hvis en eller flere af advarslerne og forsigtighedsreglerne gør sig gældende for dig.
English: Elderly patients may be more susceptible to serious neurologic events such as cognitive disorder, encephalopathy, and confusion.
Danish: Ældre patienter kan være mere modtagelige over for alvorlige neurologiske hændelser såsom kognitive forstyrrelser, encefalopati og konfusion.
English: Dose adjustment was possible in case of adverse events.
Danish: Justering af dosis var muligt i tilfælde af bivirkninger.
English: • Infusion rate of 2.5 mL/h for a duration of 96 hours
Danish: • En infusionshastighed på 2,5 ml/t i 96 timer
English: Cytokine release syndrome was reported in 2.9% of adult patients with MRD positive B-precursor ALL (N = 137).
Danish: Cytokinfrigivelsessyndrom blev rapporteret hos 2,9 % af voksne patienter med MRD-positiv B-prækursor ALL (N = 137).
English: BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
Danish: BLINCYTO er indiceret som monoterapi til behandling af voksne med Philadelphia-kromosom-negativ, CD19-positiv B-prækursor ALL i første eller anden komplet remission med MRD-positiv (minimal residual sygdom) større end eller lig med 0,1 %.
English: • feeling sleepy (somnolence), numbness, dizziness
Danish: • søvnighed (somnolens), følelsesløshed, svimmelhed
English: If your doctor determines that you should be given more cycles of BLINCYTO and if your body weight is greater than or equal to 45 kilograms, your pump will be set to infuse a dose of 28 micrograms per day.
Danish: Hvis din læge beslutter, at du skal have flere cyklusser af BLINCYTO, og hvis du vejer 45 kg eller derover, vil din infusionspumpe blive indstillet til at give en dosis på 28 mikrogram om dagen.
English: Bacterial infections a, b
Danish: Bakterieinfektioner a, b
English: The physician educational material should contain: A link to the Summary of Product Characteristics (SmPC) The guide for physicians shall contain the following key elements:
Danish: Undervisningsmaterialet til læger skal indeholde: Et link til produktresuméet (SmPC) Vejledningen til læger skal indeholde følgende nøgleelementer:
English: Patients with brain MRI/CT findings consistent with leukoencephalopathy experienced concurrent serious adverse events including confusional state, tremor, cognitive disorder, encephalopathy, and convulsion.
Danish: Patienter med fund på hjerne-MRI/CT svarende til leukoencefalopati havde samtidige alvorlige bivirkninger, herunder konfusion, tremor, kognitiv lidelse, encefalopati og krampeanfald.
English: The treated population included 189 patients who received at least 1 infusion of BLINCYTO; the mean number of cycles per patient was 1.6.
Danish: Den behandlede population inkluderede 189 patienter, som fik mindst 1 infusion af BLINCYTO.
English: • Patient / caregivers educational material
Danish: • Undervisningsmateriale til patienter/omsorgspersoner
English: • BLINCYTO is compatible with polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
Danish: • BLINCYTO er kompatibelt med infusionsposer/pumpekassetter af polyolefin, non-di(2ethylhexyl)ftalat (non-DEHP) til PVC eller ethylvinylacetat (EVA).
English: In BLINCYTO-treated patients in the randomised phase III clinical study (N = 267) and the single arm phase II clinical study (N = 189), 66.0% of patients experienced one or more neurologic adverse reactions (including psychiatric disorders), primarily involving the central nervous system.
Danish: Blandt de BLINCYTO-behandlede patienter i det randomiserede, kliniske fase III-studie (N = 267) og i det kliniske fase II-studie med en enkelt behandlingsarm (N = 189) fik 66,0 % af patienterne en eller flere neurologiske bivirkninger (herunder psykiske forstyrrelser), der primært involverede centralnervesystemet.
English: 3.1 months (2.6, 4.3) (N = 32)
Danish: 3,1 måneder (2,6; 4.3) (N = 32)
English: For reinitiation, premedicate with a 24 mg dose of dexamethasone.
Danish: Ved reinitiering præmedicineres med en dosis dexamethason på 24 mg. Nedtrap derefter dexamethason trinvis over 4 dage.
English: Initiation of BLINCYTO treatment causes transient release of cytokines during the first days of treatment that may suppress CYP450 enzymes.
Danish: Initiering af behandling med BLINCYTO forårsager forbigående frigivelse af cytokiner i de første dage af behandlingen.
English: Grade ≥ 3 and grade ≥ 4 events, respectively, were reported for 8.0% and 4.4% of adult patients with MRD positive B-precursor ALL.
Danish: Der blev rapporteret om hændelser grad ≥ 3 og grad ≥ 4 for henholdsvis 8,0% og 4,4% af voksne patienter med MRD-positiv B-prækursor ALL.
English: • BLINCYTO treatment start date
Danish: • Dato for start af behandling med BLINCYTO
English: For clinical management of pancreatitis, see section 4.4.
Danish: 4.4 vedrørende den kliniske behandling af pancreatitis.
English: • Recommendation for patients not to drive while receiving BLINCYTO and to contact immediately the treating physician if they experience neurological symptoms
Danish: • Anbefaling til patienterne om ikke at køre bil, mens de får BLINCYTO, og om straks at kontakte den behandlende læge, hvis de udvikler neurologiske symptomer
English: • Contact details of the BLINCYTO prescriber
Danish: • Kontaktoplysninger om den læge, der har ordineret BLINCYTO
English: • Recommendation for patients not to drive while receiving BLINCYTO and to contact immediately the treating physician/nurse if they experience neurological symptoms
Danish: • Anbefaling til patienterne om ikke at køre bil, mens de får BLINCYTO, og om straks at kontakte den behandlende læge/sygeplejersken, hvis de udvikler neurologiske symptomer
English: Sodium chloride 9 mg/mL (0.9%) (starting volume)
Danish: Natriumchlorid 9 mg/ml (0,9 %) (startvolumen)
English: Relapse was defined as haematological relapse (blasts in bone marrow greater than 5% following CR) or an extramedullary relapse.
Danish: 5 Recidiv blev defineret som et hæmatologisk recidiv (blastceller i knoglemarv på over 5 % efter CR) eller et ekstramedullært recidiv.
English: Therefore once the CSF is cleared, treatment with BLINCYTO may be initiated.
Danish: Behandling med BLINCYTO kan derfor initieres, når CSV er renset.
English: Gently mix the contents of the bag to avoid foaming.
Danish: Bland posens indhold forsigtigt for at undgå dannelse af skum.
English: 28 mcg/day
Danish: 28 mikrog/dag
English: In BLINCYTO-treated patients in the randomised phase III clinical study (N = 267) and the single arm phase II clinical study (N = 189), serious CRS reactions were reported in 2.4% of patients with a median time to onset of 2 days.
Danish: Blandt de BLINCYTO-behandlede patienter i det randomiserede, kliniske fase III-studie (N = 267) og i det kliniske fase II-studie med en enkelt behandlingsarm (N = 189) blev der indberettet alvorlige CRS-reaktioner hos 2,4 % af patienterne med en mediantid indtil hændelsernes indtræden på 2 dage.
English: In the event of a seizure, secondary prophylaxis with appropriate anticonvulsant medicinal products (e.g. levetiracetam) is recommended.
Danish: Sekundær profylakse med passende antikonvulsiva (fx levetiracetam) anbefales i tilfælde af krampeanfald.
English: Time to alloHSCT among CR/CRh*/CRi responders Median time to event [95% CI] (KM estimate)
Danish: Tid indtil allo-HSCT blandt CR/CRh*/CRi-respondere Mediantid indtil hændelse [95 % CI] (KM-estimat)
English: After reconstitution with water for injections each vial contains 12.5 micrograms/mL of blinatumomab.
Danish: Efter rekonstitution med vand til injektionsvæsker indeholder hvert hætteglas 12,5 mikrogram/ml blinatumomab.
English: The BLINCYTO solution for infusion must be administered using intravenous tubing that contains a sterile, non-pyrogenic, low protein-binding 0.2 micrometre in-line filter.
Danish: BLINCYTO infusionsvæske, opløsning, skal administreres med anvendelse af en intravenøs slange med et sterilt, pyrogenfrit 0,2 mikrometer integreret filter med lav proteinbinding.
English: Neutropenia Thrombocytopenia Leukopenia
Danish: Trombocytopeni Leukopeni
English: BLINCYTO is a powder for concentrate and solution for solution for infusion.
Danish: BLINCYTO er et pulver til koncentrat og opløsning til infusionsvæske, opløsning.
English: Based on its pharmacological properties, a risk to the suckling child cannot be excluded.
Danish: En risiko for det diende barn kan ikke udelukkes på baggrund af stoffets farmakologiske egenskaber.
English: Consider discontinuing BLINCYTO permanently.
Danish: Overvej at seponere BLINCYTO permanent.
English: • Infusion rate of 3.3 mL/h for a duration of 72 hours
Danish: • En infusionshastighed på 3,3 ml/t i 72 timer
English: Solution (stabiliser).
Danish: Opløsning (stabilisator).
English: < 1 year old achieved a CR/CRh
Danish: Ingen af de 3 patienter < 1 år opnåede CR/CRh
English: 5-free survival (RFS) for CR/CRh*
Danish: Delvis remission Recidivfri overlevelse (RFS) for CR/CRh*
English: The pharmacist educational material should contain: A link to the Summary of Product Characteristics (SmPC) The guide for pharmacists, containing the following key elements:
Danish: Undervisningsmaterialet til apotekspersonale skal indeholde: Et link til produktresuméet (SmPC) Vejledningen til apotekspersonale, der indeholder følgende nøgleelementer:
English: Contact details are provided in section 6 of the package leaflet.
Danish: Indlægssedlens punkt 6 indeholder kontaktoplysninger.
English: Table 9.
Danish: Tabel 9.
English: Eligible patients were ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-precursor ALL (relapsed with first remission duration of ≤ 12 months in first salvage, or relapsed or refractory after first salvage therapy, or relapsed within 12 months of allogeneic HSCT, and had ≥ 10% blasts in bone marrow).
Danish: Egnede patienter var ≥ 18 år og havde Philadelphia-kromosom-negativ recidiveret eller refraktær B-prækursor ALL (recidiveret med en varighed af første remission på ≤ 12 måneder inden for første livreddende behandling eller recidiveret eller refraktær efter første livreddende behandling eller recidiveret inden for 12 måneder efter allogen hæmatopoietisk stamcelletransplantation [HSCT] og med ≥ 10 % blastceller i knoglemarv).
English: Grade ≥ 3 and grade ≥ 4 events, respectively, were reported for 16.1% and 2.2% of adult patients with MRD positive B-precursor ALL.
Danish: Der blev rapporteret om hændelser grad ≥ 3 og grad ≥ 4 for henholdsvis 16,1 % og 2,2 % af voksne patienter med MRD-positiv B-prækursor ALL.
English: • 38.5 micrograms blinatumomab powder in a vial (type I glass) with a stopper (elastomeric rubber), seal (aluminium) and a flip off cap and
Danish: • 38,5 mikrogram blinatumomab pulver i et hætteglas (type I-glas) med en prop (elastomer),
English: For instructions on administration, see Summary of Product Characteristics section 4.2.
Danish: 4.2 i produktresuméet for instruktion til administration.
English: Eligible patients were ≥ 18 years of age and ECOG status ≤ 2 with relapsed or refractory B-cell precursor ALL (had > 5% blasts in the bone marrow and either relapse at any time after allogeneic HSCT, untreated first relapse with first remission duration < 12 months, or refractory to last therapy).
Danish: Egnede patienter var ≥ 18 år og havde ECOG-status ≤ 2 med recidiveret eller refraktær B-prækursor ALL (havde > 5 % blastceller i knoglemarv og enten recidiv på et vilkårligt tidspunkt efter allogen HSCT, ubehandlet første recidiv med en varighed af første remission på < 12 måneder eller refraktær over for seneste behandling).
English: Store the vials in the original package in order to protect from light.
Danish: Hætteglassene skal opbevares i den originale pakning for at beskytte mod lys.
English: When administering via a multi-lumen venous catheter, BLINCYTO should be infused through a dedicated lumen.
Danish: Ved administration via et venekateter med flere lumener, skal BLINCYTO infunderes gennem en selvstændig åbning.
English: Unopened vials:
Danish: Uåbnede hætteglas:
English: • Infusion rate of 10 mL/h for a duration of 24 hours
Danish: • En infusionshastighed på 10 ml/t i 24 timer
English: SOC chemotherapy (N = 134)
Danish: SB kemoterapi (N = 134)
English: Hepatic enzyme increased a, 15
Danish: Stigning i leverenzymer a, 15
English: Subgroup
Danish: Delgruppe
English: Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL.
Danish: Rekonstitution med vand til injektionsvæsker giver en endelig koncentration af blinatumomab-koncentrat på 12,5 mikrogram/ml.
English: Cytokine release syndrome (CRS) which may be life-threatening or fatal (grade ≥ 4) has been reported in patients receiving BLINCYTO (see section 4.8).
Danish: Der er indberettet cytokinfrigivelsessyndrom (CRS), som kan være livstruende eller fatal (grad ≥ 4), hos patienter, der fik BLINCYTO (se pkt.
English: Reproductive toxicity studies have not been conducted with blinatumomab.
Danish: Der er ikke udført studier af reproduktionstoksiciteten af blinatumomab.
English: Verify the prescribed dose and infusion time of BLINCYTO and identify the appropriate dosing preparation in the relevant table below.
Danish: Kontrollér den ordinerede dosis og infusionstid for BLINCYTO og find det afsnit med klargøring af doseringen i den relevante tabel nedenfor.
English: 3.6 months (2.3, 7.2) (N = 33)
Danish: 3,6 måneder (2,3; 7,2) (N = 33)
English: SOC Chemo
Danish: SB kemo
English: Diluted solution (prepared infusion bag)
Danish: Fortyndet opløsning (klargjort infusionspose)
English: • Infusion rate of 5 mL/h for a duration of 48 hours
Danish: • En infusionshastighed på 5 ml/t i 48 timer
English: BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
Danish: BLINCYTO er indiceret som monoterapi til behandling af voksne med Philadelphia-kromosom-negativ CD19-positiv recidiveret eller refraktær B-prækursor akut lymfoblastisk leukæmi (ALL).