FrancophonIA/ELRC3.0 huggingface dataset:
English: o Use only polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
Danish: o Brug kun infusionsposer/pumpekasssetter af polyolefin, non-di(2ethylhexyl)ftalat (non-DEHP) til PVC eller ethylvinylacetat (EVA).
English: Tumour lysis syndrome (TLS), which may be life-threatening or fatal (grade ≥ 4) has been observed in patients receiving BLINCYTO.
Danish: Der er observeret tumorlysesyndrom (TLS), som kan være livstruende eller fatal (grad ≥ 4), hos patienter, der fik BLINCYTO.
English: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion blinatumomab
Danish: BLINCYTO 38,5 mikrogram pulver til koncentrat og opløsning til infusionsvæske, opløsning blinatumomab
English: Speech disorder
Danish: Taleforstyrrelser
English: (cranial nerve disorders)
Danish: (sygdom i kranienerverne)
English: Lymphopenia includes lymphocyte count decreased and lymphopenia.
Danish: 6 Lymfopeni omfatter fald i lymfocytter og lymfopeni.
English: One vial of powder contains 38.5 micrograms blinatumomab.
Danish: Et hætteglas med pulver indeholder 38,5 mikrogram blinatumomab.
English: Duration of haematological responseMedian time to event [95% CI] CR
Danish: Varighed af hæmatologisk respons Mediantid indtil hændelse [95 % CI] CR
English: Infusion pump and intravenous tubing
Danish: Infusionspumpe og intravenøs slange
English: For clinical management of infections, see section 4.4.
Danish: 4.4 vedrørende den kliniske behandling af infektioner.
English: Elderly
Danish: Alder
English: Preparation of BLINCYTO should be:
Danish: BLINCYTO indeholder:
English: 9 mcg/day
Danish: 9 mikrog/dag
English: Justification for not including Braille accepted.
Danish: Fritaget fra krav om brailleskrift.
English: Efficacy results in patients ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL)
Danish: Effektresultater hos patienter på ≥ 18 år med Philadelphia-kromosom-negativ recidiveret eller refraktær B-prækursor akut lymfoblast leukæmi (ALL)
English: 1 Anaemia includes anaemia and haemoglobin decreased.
Danish: Anæmi omfatter anæmi og fald i hæmoglobin.
English: Verify the prescribed dose and infusion time of BLINCYTO and identify the appropriate dosing preparation section listed below.
Danish: Kontrollér den ordinerede dosis og infusionstid for BLINCYTO og find det afsnit med klargøring af doseringen nedenfor.
English: No formal pharmacokinetic studies of blinatumomab have been conducted in patients with renal impairment.
Danish: Der er ikke udført formelle farmakokinetiske studier af blinatumomab hos patienter med nedsat leverfunktion.
English: Follow the steps for reconstituting BLINCYTO and preparing the infusion bag detailed below table 9.
Danish: Følg proceduren for rekonstituering af BLINCYTO og klargøring af infusionsposen, der er angivet under tabel 9.
English: BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
Danish: BLINCYTO er indiceret som monoterapi til behandling af pædiatriske patienter i alderen 1 år og derover med Philadelphia-kromosom-negativ CD19-positiv B-prækursor ALL, som er refraktær eller recidiveret efter mindst to tidligere behandlinger, eller recidiveret efter tidligere allogen hæmatopoietisk stamcelletransplantation.
English: In BLINCYTO-treated patients in the randomised phase III clinical study (N = 267) and the single arm phase II clinical study (N = 189), 22.4% of patients reported elevated liver enzymes and associated signs/symptoms.
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 stigninger i leverenzymer og tilhørende tegn/symptomer hos 22,4 % af patienterne.
English: • Nurse educational material
Danish: • Undervisningsmateriale til sygeplejersker
English: Each vial of powder contains 38.5 micrograms of blinatumomab.
Danish: Hvert hætteglas med pulver indeholder 38,5 mikrogram blinatumomab.
English: Fungal infections a, b
Danish: Svampeinfektioner a, b
English: Do not prime with sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Må ikke primes med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: ≥ 65 years old Patients in 1
Danish: ≥ 65 år
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet.
English: Women of childbearing potential have to use effective contraception during and for at least 48 hours, after treatment with BLINCYTO (see section 4.6).
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i mindst 48 timer efter behandlingen med BLINCYTO (se pkt.
English: How to use BLINCYTO
Danish: Sådan skal du bruge BLINCYTO
English: Powder for concentrate and solution for solution for infusion 1 vial of powder.
Danish: Pulver til koncentrat og opløsning til infusionsvæske, opløsning 1 hætteglas med pulver.
English: Median, years (min, max) Mean, years (SD) ≥ 65 Years, n (%) Prior salvage therapy
Danish: Gennemsnit, år (SD) ≥ 65 år, n (%)
English: Refractory status - n (%)
Danish: Race, n (%)
English: Elevated liver enzyme events were reported for 12.4% of adult patients with MRD positive B-precursor ALL (N = 137).
Danish: Der blev rapporteret forhøjede leverenzymer hos 12,4 % af voksne patienter med MRD-positiv B-prækursor ALL (N = 137).
English: For clinical management of CRS, see section 4.4.
Danish: 4.4 vedrørende den kliniske behandling af CRS.
English: Management of these signs and symptoms to resolution may require either temporary interruption or permanent discontinuation of BLINCYTO (see section 4.2).
Danish: Behandling af disse tegn og symptomer, indtil de er forsvundet, kan nødvendiggøre enten midlertidig afbrydelse eller permanent seponering af BLINCYTO (se pkt.
English: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Danish: BLINCYTO 38,5 mikrogram pulver til koncentrat og opløsning til infusionsvæske, opløsning.
English: MRD (minimum residual disease) response was defined as MRD by PCR or flow cytometry < 1 x 10 f. Patients who achieved CR/CRh*/CRi and had an evaluable post baseline MRD assessment.
Danish: < 1 x 10 f. Patienter, der opnåede CR/CRh*/CRi og havde en evaluerbar MRD-vurdering efter baseline.
English: Blast free hypoplastic or aplastic bone marrow was defined as bone marrow blasts ≤ 5%, no evidence of disease, insufficient recovery of peripheral blood counts: platelets ≤ 50,000/microlitre and/or ANC ≤ 500/microlitre.
Danish: Blastcellefri hypoplastisk eller aplastisk knoglemarv blev defineret som blastceller i knoglemarv på ≤ 5 %, ingen tegn på sygdom, utilstrækkelig genoprettelse af perifere blodtal: trombocytter ≤ 50.000/mikroliter og/eller ANC ≤ 500/mikroliter.
English: Cytokine release syndrome, tumour lysis syndrome
Danish: Cytokinfrigivelsessyndrom, tumorlysesyndrom
English: Follow the steps for reconstituting BLINCYTO and preparing the infusion bag detailed below table 3.
Danish: Følg proceduren for rekonstituering af BLINCYTO og klargøring af infusionsposen, der er angivet under tabel 3.
English: • fever, swelling, chills, decreased or increased blood pressure and fluid in the lungs, which may be severe and can be fatal (cytokine storm)
Danish: • feber, hævelse, kulderystelser, nedsat eller forhøjet blodtryk og væske i lungerne, som kan blive alvorligt og være fatalt (cytokinstorm)
English: 10 mL/hour
Danish: 10 ml/time
English: • Pharmacist educational material
Danish: • Undervisningsmateriale til apotekspersonale
English: Bone Marrow Blast Infiltration (Central Lab)
Danish: Infiltration af knoglemarvsblastceller (centrallaboratoriet)
English: Under aseptic conditions, attach the intravenous tubing to the infusion bag with the sterile 0.2 micron in-line filter.
Danish: Sæt den intravenøse slange på infusionsposen med det sterile intregrerede 0,2 mikron filter under aseptiske betingelser.
English: BLINCYTO 38.5 mcg powder for concentrate blinatumomab
Danish: BLINCYTO 38,5 mikrog pulver til koncentrat blinatumomab i.v.
English: Currently available data in children are described in section 4.8 and 5.1.
Danish: De foreliggende data for børn er beskrevet i pkt.
English: 3.3 mL/hour
Danish: 3,3 ml/time
English: Postbaseline alloHSCT - n (%) Overall subjects Hematological responders (CR/CRh*/CRi) Time to alloHSCT among all transplanted patients Median time to event (Interquartile range)
Danish: Tid indtil allo-HSCT blandt alle transplanterede patienter Mediantid indtil hændelse (interkvartilt område)
English: • fever, swelling, chills, decreased or increased blood pressure and fluid in the lungs, which may become severe (cytokine release syndrome)
Danish: • feber, hævelse, kulderystelser, nedsat eller forhøjet blodtryk og væske i lungerne, som kan blive alvorligt (cytokinfrigivelsessyndrom)
English: Of the 267 patients who received BLINCYTO, the mean number of completed treatment cycles was 2.0; of the 109 patients who received SOC chemotherapy, the mean number of treatment cycles was 1.3.
Danish: Af de 267 patienter, der fik BLINCYTO, var det gennemsnitlige antal fuldførte behandlingscyklusser 2,0.
English: The safety of BLINCYTO has not been studied in patients with severe renal impairment.
Danish: BLINCYTOs sikkerhed er ikke blevet undersøgt hos patienter med alvorlig nyresvækkelse.
English: Infusion rate
Danish: Infusionskateter
English: Somnolence Hypoaesthesia Cranial nerve disorder b
Danish: Krampeanfald Kognitiv forstyrrelse Svækket hukommelse Svimmelhed Somnolens Hypoæstesi Sygdom i kranienerver b
English: Interrupt BLINCYTO until resolved, then restart BLINCYTO at 5 mcg/m2/day.
Danish: Afbryd BLINCYTO, indtil tilstanden er forsvundet, og genstart derefter BLINCYTO med 5 mikrog/m2/dag.
English: See table 6 for the efficacy results.
Danish: Effektresultaterne findes i tabel 6.
English: Contact your doctor or nurse if you have questions.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: 4817 ZK Breda The Netherlands
Danish: Minervum 7061 4817 ZK Breda Holland
English: Efficacy results in patients < 18 years of age with relapsed or refractory B-cell precursor ALL
Danish: Effektresultater hos patienter < 18 år med recidiveret eller refraktær B-prækursor ALL
English: The safety and efficacy of BLINCYTO have not been studied in patients with severe hepatic impairment.
Danish: BLINCYTOs sikkerhed og effekt er ikke blevet undersøgt hos patienter med alvorlig leversvækkelse.
English: 5 mL/hour
Danish: 5 ml/time
English: Oedema includes face oedema, generalised oedema, oedema and oedema peripheral.
Danish: Ødem omfatter ansigtsødem, generaliseret ødem, ødem og perifert ødem.
English: Duration of MRD responseMedian time to event [95% CI]
Danish: Varighed af MRD-respons Mediantid indtil hændelse [95 % CI]
English: Efficacy results in patients ≥ 18 years of age with Philadelphia chromosome negative relapsed or refractory B-cell precursor ALL
Danish: Effektresultater hos patienter ≥ 18 år med Philadelphia-kromosom-negativ recidiveret eller refraktær B-prækursor ALL
English: Women of childbearing potential have to use effective contraception during and for at least 48 hours after treatment with blinatumomab (see section 4.4).
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i mindst 48 timer efter behandlingen med blinatumomab (se pkt.
English: SOC Chemo (N=134)
Danish: SB kemo (N=134)
English: Sodium chloride 9 mg/mL (0.9%) solution for injection (starting volume)
Danish: Natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning (startvolumen)
English: 6-month estimate % [95% CI] 18-months estimate % [95% CI] HR [95% CI]
Danish: 's estimat % [95 % CI] HR [95 % CI]
English: Management of infections may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Danish: Behandlingen af infektioner kan nødvendiggøre enten midlertidig afbrydelse eller seponering af BLINCYTO (se pkt.
English: Grade 3 Interrupt BLINCYTO until resolved, then restart BLINCYTO at 9 mcg/day.
Danish: Afbryd BLINCYTO, indtil tilstanden er forsvundet, og genstart derefter BLINCYTO med 9 mikrog/dag.
English: If the toxicity occurred at 5 mcg/m2/day, or if the toxicity takes more than 7 days to resolve, discontinue BLINCYTO permanently
Danish: Seponér BLINCYTO permanent, hvis toksiciteten er opstået ved 5 mikrog/m2/dag, eller det tager mere end 7 dage, før toksiciteten forsvinder
English: Infusion duration
Danish: Infusionshastighed
English: • coughing with phlegm
Danish: • hoste med slim
English: The safety and efficacy of BLINCYTO have not been studied in patients with severe renal impairment.
Danish: BLINCYTOs sikkerhed og effekt er ikke blevet undersøgt hos patienter med alvorlig nyresvækkelse.
English: Cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO, especially in patients with prior treatment with cranial irradiation and anti-leukaemic chemotherapy (including systemic high dose methotrexate or intrathecal cytarabine).
Danish: Dette var især patienter, der havde fået tidligere behandling med bestråling af kraniet og antileukæmisk kemoterapi (herunder systemisk højdosismethotrexat eller intratekal cytarabin).
English: SOC Chemo 134
Danish: BLINCYTO 271 SB kemo 134
English: Management of these events may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Danish: Behandlingen af disse hændelser kan nødvendiggøre enten midlertidig afbrydelse eller seponering af BLINCYTO (se pkt.
English: If the toxicity occurred at 9 mcg/day, or if the toxicity takes more than 7 days to resolve, discontinue
Danish: Seponér BLINCYTO permanent, hvis toksiciteten er opstået ved 9 mikrog/dag, eller det tager mere end 7 dage, før toksiciteten forsvinder.
English: Infusion catheter
Danish: Infusionsvarighed
English: What BLINCYTO is and what it is used for What you need to know before you use BLINCYTO How to use BLINCYTO
Danish: Det skal du vide, før du begynder at bruge BLINCYTO Sådan skal du bruge BLINCYTO Bivirkninger
English: Psychiatric disorders a
Danish: Psykiske forstyrrelser a
English: Lymphadenopathy Histiocytosis haematophagic
Danish: Lymfadenopati Hæmatofagisk histiocytose
English: 1 vial of solution (stabiliser).
Danish: 1 hætteglas med opløsning (stabilisator).
English: c. CRi (complete remission with incomplete haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and incomplete recovery of peripheral blood counts (platelets > 100,000/microlitre or ANC > 1,000/microlitre).
Danish: CRi (komplet remission med ufuldstændig hæmatologisk genoprettelse) blev defineret som ≤ 5 % blastceller i knoglemarv, ingen tegn på sygdom og ufuldstændig genoprettelse af perifere blodtal (trombocytter > 100.000/mikroliter eller ANC > 1.000/mikroliter).
English: Pre-filled bag containing sodium chloride 9 mg/mL (0.9%) solution for injection
Danish: Fyldt pose med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning
English: Your treatment may also be interrupted depending on how you tolerate BLINCYTO.
Danish: Det afhænger af, hvor godt du tåler BLINCYTO.
English: b. CRh*was defined as M1 marrow (≤ 5% of blasts in the bone marrow), no evidence of circulating blasts or extramedullary disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre) and no relapse within 28 days.
Danish: b. CRh* blev defineret som M1-marv (≤ 5 % af blastcellerne i knoglemarv), ingen tegn på cirkulerende blastceller eller ekstramedullær sygdom og delvis genoprettelse af perifere blodtal (trombocytter > 50.000/mikroliter og ANC > 500/mikroliter) samt intet recidiv inden for 28 dage.
English: • complications occurring after cancer treatment leading to increased blood levels of potassium,
Danish: • komplikationer efter kræftbehandlingen, der fører til forhøjede niveauer af kalium, urinsyre og fosfat og nedsatte niveauer af calcium (tumorlysesyndrom)
English: Blast free hypoplastic or aplastic bone marrow Partial remission
Danish: Blastcellefri hypoplastisk eller aplastisk knoglemarv
English: Management of pancreatitis may require either temporary interruption or discontinuation of BLINCYTO (see section 4.2).
Danish: Behandlingen af pancreatitis kan nødvendiggøre enten midlertidig eller permanent seponering af BLINCYTO (se pkt.
English: Grade* Action for patients greater than or equal to 45 kg
Danish: Handling for patienter, der vejer 45 kg eller derover
English: Decreased immunoglobulins
Danish: Fald i immunglobuliner
English: CRh* was defined as ≤ 5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre).
Danish: CRh* blev defineret som ≤ 5 % af blastcellerne i knoglemarv, ingen tegn på sygdom og delvis genoprettelse af perifere blodtal (trombocytter > 50.000/mikroliter og ANC > 500/mikroliter).
English: Powder: citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80 and sodium hydroxide.
Danish: Pulver: citronsyremonohydrat (E330), trehalosedihydrat, lysinhydrochlorid, polysorbat 80 og natriumhydroxid.
English: Encephalopathy Aphasia
Danish: Vaskulære sygdomme
English: d.
Danish: c.
English: For patients weighing greater than or equal to 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag
Danish: For patienter, der vejer 45 kg eller derover: volumener af natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, opløsning (stabilisator) og rekonstitueret BLINCYTO, der skal tilsættes til infusionsposen
English: Citric acid monohydrate (E330) Lysine hydrochloride Polysorbate 80
Danish: Citronsyremonohydrat (E330) Lysinhydrochlorid
English: - The solution (stabiliser) contains citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
Danish: - Opløsningen (stabilisatoren) indeholder citronsyremonohydrat (E330), lysinhydrochlorid, polysorbat 80, natriumhydroxid og vand til injektionsvæsker.
English: - The other ingredients in the powder are citric acid monohydrate (E330), trehalose dihydrate, lysine hydrochloride, polysorbate 80, and sodium hydroxide.
Danish: - Øvrige indholdsstoffer i pulveret: citronsyremonohydrat (E330), trehalosedihydrat, lysinhydrochlorid, polysorbat 80 og natriumhydroxid.
English: Solution (stabiliser): citric acid monohydrate (E330), lysine hydrochloride, polysorbate 80, sodium hydroxide and water for injections.
Danish: Opløsning (stabilisator): citronsyremonohydrat (E330), lysinhydrochlorid, polysorbat 80, natriumhydroxid og vand til injektionsvæsker.
English: CRh* (complete remission with partial haematologic recovery) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets > 50,000/microlitre and ANC > 500/microlitre).
Danish: b. CRh* (komplet remission med delvis hæmatologisk genoprettelse) blev defineret som ≤ 5 % blastceller i knoglemarv, ingen tegn på sygdom og delvis genoprettelse af perifere blodtal (trombocytter > 50.000/mikroliter og ANC > 500/mikroliter).
English: • decreased levels of red blood cells (anaemia), decreased levels of platelets
Danish: • nedsat antal røde blodlegemer (anæmi), nedsat antal blodplader (trombocytopeni), nedsat antal af visse hvide blodlegemer (leukopeni)
English: 2.5 mL/hour
Danish: 2,5 ml/time
English: 5 mcg/m2/day via continuous infusion (not to exceed 9 mcg/day)
Danish: 5 mikrog/m2/ dag ved kontinuerlig infusion (må ikke overskride 9 mikrog/dag)
English: a. CR was defined as M1 marrow (≤ 5% of blasts in the bone marrow), no evidence of circulating blasts or extramedullary disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre) and no relapse within 28 days.
Danish: a. CR blev defineret som M1-marv (≤ 5 % blastceller i knoglemarv), ingen tegn på cirkulerende blastceller eller ekstramedullær sygdom og fuld genoprettelse af perifere blodtal (trombocytter > 100.000/mikroliter og absolutte neutrofiler [ANC] > 1.000/mikroliter) samt intet recidiv inden for 28 dage.
English: Primary refractory
Danish: • knoglesmerter
English: The treated population included 116 patients who received at least one infusion of BLINCYTO; the mean number of completed treatment cycles was 1.8 (range: 1 to 4).
Danish: Det gennemsnitlige antal gennemførte cyklusser var 1,8 (interval: 1 til 4).
English: Ataxia
Danish: Paræstesi
English: For clinical management of elevated liver enzymes, see section 4.4.
Danish: 4.4 vedrørende den kliniske behandling af forhøjede leverenzymer.
English: (%) [95% CI] CRh*, n1/n2d (%) [95% CI] Median relapse e-free survival (RFS)
Danish: (%) [95 % CI] CRh*, n1/n2
English: Leukopenia includes leukopenia and white blood cell count decreased.
Danish: 4 Leukopeni omfatter leukopeni og fald i hvide blodlegemer.
English: • When preparing an infusion bag, remove all air from infusion bag.
Danish: • Al luft skal fjernes fra infusionsposen, når den klargøres.
English: 15 mcg/m2/day via continuous infusion (not to exceed 28 mcg/day)
Danish: 15 mikrog/m2/ dag ved kontinuerlig infusion (må ikke overskride 28 mikrog/dag)
English: Grade 3 Interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at
Danish: Afbryd BLINCYTO indtil maksimalt grad 1 (mild).
English: Febrile neutropenia Anaemia
Danish: Blod og lymfesystem Febril neutropeni Anæmi
English: For patients weighing less than 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag for 15 mcg/m2/day dose
Danish: For patienter, der vejer under 45 kg: volumener af natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, stabilisator (opløsning) og rekonstitueret BLINCYTO, der skal tilsættes til infusionsposen for doser på 15 mikrog/m2/dag
English: For patients weighing less than 45 kg: volumes of sodium chloride 9 mg/mL (0.9%) solution for injection, solution (stabiliser), and reconstituted BLINCYTO to add to infusion bag for 5 mcg/m2/day dose
Danish: For patienter, der vejer under 45 kg: volumener af natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, stabilisator (opløsning) og rekonstitueret BLINCYTO, der skal tilsættes til infusionsposen for doser på 5 mikrog/m2/dag
English: CR was defined as ≤ 5% of blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre).
Danish: CR blev defineret som ≤ 5 % af blastcellerne i knoglemarv, ingen tegn på sygdom og komplet genoprettelse af perifere blodtal (trombocytter > 100.000/mikroliter og absolutte neutrofiltal [ANC] > 1.000/mikroliter).
English: CR MRD level at baseline* n (%) and < 1 ≥ 10-2 and < 10-1 and < 10
Danish: MRD-niveau ved baseline* n (%)
English: Your doctor will determine when your BLINCYTO infusion bag will be changed, which may range from every day to every 4 days.
Danish: Din læge vil bestemme, hvornår din infusionspose med BLINCYTO skal skiftes.
English: 5 mcg/m 2/day via continuous infusion (not to exceed 9 mcg/day)
Danish: 5 mikrog/m dag ved kontinuerlig infusion (må ikke overskride 9 mikrog/dag)
English: Unopened vials
Danish: Uåbnede hætteglas
English: Change of infusion bag
Danish: Udskiftning af infusionspose
English: Powder for concentrate and solution for solution for infusion.
Danish: Pulver til koncentrat og opløsning til infusionsvæske, opløsning.
English: Check with your doctor, pharmacist or nurse if you are not sure.
Danish: - Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.