FrancophonIA/ELRC3.0 huggingface dataset:
English: High-dose steroid therapy may have contributed, in some cases, to the pancreatitis.
Danish: Behandling med højdosis-steroider kan i nogle tilfælde have været en del af årsagen til pancreatitis.
English: Action for patients less than 45 kg
Danish: Handling for patienter, der vejer under 45 kg
English: Results from an in vitro test in human hepatocytes suggest that blinatumomab did not affect CYP450 enzyme activities.
Danish: Resultaterne fra en test in vitro med humane hepatocytter tyder på, at blinatumomab ikke påvirker aktiviteterne af CYP450-enzymer.
English: The elevated cytokine levels returned to baseline within 24 to 48 hours during the infusion.
Danish: De forhøjede cytokinniveauer vendte tilbage til niveauet ved baseline inden for 24 til 48 timer under infusionen.
English: Demographics and baseline characteristics in phase III study
Danish: Demografi og baselinekarakteristika i fase III-studie
English: Patients were premedicated with a mandatory cerebrospinal fluid prophylaxis consisting of an intrathecal regimen according to institutional or national guidelines within 1 week prior to start of BLINCYTO treatment.
Danish: Patienterne blev præmedicineret med en obligatorisk profylakse af cerebrospinalvæsken bestående af et intratekalt regimen i henhold til institutionens eller de nationale retningslinjer inden for 1 uge inden start af behandling med BLINCYTO.
English: However the influence is negligible in adults and body surface area based dosing is recommended in the paediatric population.
Danish: Påvirkningen er dog ubetydelig hos voksne, og dosering på basis af legemsoverfladeareal anbefales i den pædiatriske population.
English: Your doctor will assess your nervous system and conduct tests before deciding if you should receive BLINCYTO.
Danish: Din læge vil vurdere dit nervesystem og udføre nogle test, inden det besluttes, om du skal have BLINCYTO.
English: * The study protocol needs to be developed and presented for PRAC review within 2 months after the EU Commission Decision.
Danish: * Studieprotokollen skal udarbejdes og præsenteres for PRAC til gennemgang inden for 2 måneder efter EuropaKommissionens beslutning
English: BLINCYTO was administered as a continuous intravenous infusion.
Danish: BLINCYTO blev administreret som en kontinuerlig intravenøs infusion.
English: Days 1-7
Danish: Dag 1-7
English: - When refrigerated, the infusion bags must be used within 10 days of preparation.
Danish: - Ved opbevaring i køleskab skal infusionsposerne bruges inden for 10 dage efter klargøring.
English: • there is a problem with the pump or the pump alarm sounds
Danish: • Der er et problem med pumpen, eller pumpens alarm går i gang.
English: Cycle 1
Danish: Cyklus 1
English: In paediatric patients, dexamethasone 10 mg/m
Danish: Hos pædiatriske patienter bør dexamethason 10 mg/m
English: This belongs to a group of medicines called antineoplastic agents which target cancer cells.
Danish: Det tilhører en gruppe lægemidler, der kaldes for antineoplastiske midler, som er rettede mod kræftceller.
English: Premedication, BLINCYTO dose per treatment cycle and route of administration were identical to those in the phase III study.
Danish: Præmedicinering, BLINCYTO-dosis pr. behandlingscyklus og administrationsvej var de samme som i fase III-studiet.
English: N = total number of patients in the specified subgroup.
Danish: N = antal patienter i alt i den viste delgruppe.
English: Berkshire, SL1 4DX UK
Danish: Berkshire, SL1 4DX Storbritannien
English: However some patients reported delayed onset of infusion reactions or in later cycles.
Danish: Nogle patienter har imidlertid rapporteret om infusionsreaktioner, der opstod forsinket eller i senere cyklusser.
English: • if you think you may need any vaccinations in the near future, including those needed to travel to other countries.
Danish: • Hvis du mener, du vil få brug for en eller flere vaccinationer inden for nærmeste fremtid.
English: • fever (pyrexia)
Danish: • feber (pyreksi)
English: Treatment should be initiated under the direction of and supervised by physicians experienced in the treatment of haematological malignancies.
Danish: Behandlingen bør initieres under ledelse og opsyn af læger med erfaring inden for behandling af hæmatologiske maligniteter.
English: • Information on treatment with BLINCYTO, administration and posology, duration of hospitalisation, interruption and / or permanent discontinuation of the treatment Medication errors (ME)
Danish: • Information om behandling med BLINCYTO, administration og dosering, varighed af hospitalsindlæggelse, afbrydelse og/eller permanent seponering af behandlingen Medicineringsfejl
English: BSA = body surface area
Danish: BSA = legemsoverfladeareal
English: One CR /CRh*responder with missing MRD data was considered as a MRDnonresponder.
Danish: En CR /CRh*-responder med manglende MRD-data blev anset som MRD-nonresponder.
English: Consistency in OS results was shown in subgroups by stratification factors.
Danish: Der blev observeret konsekvens i OSresultaterne i delgrupperne efter stratificeringsfaktorer.
English: • Use the specific volumes described in the reconstitution and dilution instructions below to minimise errors in calculation.
Danish: • Brug de specifikke volumener, der beskrives i nedenstående instruktioner til rekonstitution og fortynding, for at forebygge fejl i beregningen.
English: Pre-phase treatment for patients with high tumour burden
Danish: Forbehandling af patienter med stor tumorbyrde
English: • Description of the administration procedures of BLINCYTO
Danish: • Beskrivelse af administrationsprocedurerne for BLINCYTO
English: 250 mL (usual overfill volume of 265 to 275 mL)
Danish: 250 ml (sædvanlig ekstra volumen på 265 til 275 ml)
English: Neutropenia and febrile neutropenia
Danish: Neutropeni og febril neutropeni
English: Aseptic handling must be ensured when preparing the infusion.
Danish: Aseptisk håndtering skal sikres, når infusionen klargøres.
English: Reconstituted solution (BLINCYTO solution): - When refrigerated, the reconstituted solution must be used within 24 hours.
Danish: Rekonstitueret opløsning (BLINCYTO-opløsning): - Ved opbevaring i køleskab skal den rekonstituerede opløsning bruges inden for 24 timer.
English: Patients experiencing capillary leak syndrome should be managed promptly.
Danish: Patienter med kapillær lækage-syndrom skal behandles med det samme.
English: A population pharmacokinetic analysis was performed to evaluate the effects of demographic characteristics on blinatumomab pharmacokinetics.
Danish: Der blev udført en farmakokinetisk populationsanalyse for at evaluere virkningerne af demografiske karakteristika på blinatumomabs farmakokinetik.
English: Blinatumomab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Danish: Blinatumomab produceres i ovarieceller fra kinesisk hamster ved hjælp af rekombinant DNA-teknologi.
English: Although there is a potential for the development of progressive multifocal leukoencephalopathy (PML), no confirmed case of PML has been reported in the clinical studies.
Danish: Selvom der er mulighed for udvikling af progressiv multifokal leukoencefalopati (PML), er der ikke indberettet nogen bekræftede tilfælde i kliniske studier.
English: No recovery of peripheral B-cell counts was observed during the 2-week treatment-free period between treatment cycles.
Danish: Det blev ikke observeret, at antallet af perifere B-celler steg igen i den 2-ugers behandlingsfrie periode mellem behandlingscyklusserne.
English: Common (≥ 1/100 to < 1/10)
Danish: Almindelig (≥ 1/100 til < 1/10)
English: Your next cycles
Danish: Dine næste cyklusser
English: • decreased levels of certain white blood cells with or without fever ((febrile) neutropenia,
Danish: • nedsatte niveauer af bestemte hvide blodlegemer med eller uden feber ([febril] neutropeni,
English: Your first cycle
Danish: Din første cyklus
English: MRD response rates by age and MRD level at baseline subgroups were consistent with the results in the overall population.
Danish: MRD-responsraterne i undergrupper efter alder og MRD-niveau ved baseline svarede til resultaterne for den samlede population.
English: If the interruption of treatment after an adverse event is no longer than 7 days, continue the same cycle to a total of 28 days of infusion inclusive of days before and after the interruption in that cycle.
Danish: Hvis en afbrydelse af behandlingen efter en bivirkning ikke varer mere end 7 dage, fortsættes samme cyklus op til i alt 28 dages infusion, inklusive dagene før og efter afbrydelsen i den pågældende cyklus.
English: Before your treatment with BLINCYTO, you will be given other medicines (pre-medication) to help reduce infusion reactions and other possible side effects.
Danish: Du vil inden din behandling med BLINCYTO få andre lægemidler (præmedicinering), som skal forebygge infusionsreaktioner og andre mulige bivirkninger.
English: • Data from clinical trials, frequency and severity (grade 3 and 4 neurological toxicities were observed)
Danish: • Data fra kliniske forsøg, hyppighed og sværhedsgrad (der er observeret neurologiske toksiciteter grad 3 og 4)
English: Other special populations
Danish: Andre specielle populationer
English: For instructions on the handling and preparation of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om håndtering og klargøring af lægemidlet før administration, se pkt.
English: • low levels of antibodies called “immunoglobulins” which help the immune system fight infection (decreased immunoglobulins)
Danish: • lave niveauer af antistoffer, der kaldes for “immunglobuliner”, der hjælper immunsystemet med at bekæmpe infektioner
English: The safety of immunisation with live viral vaccines during or following BLINCYTO therapy has not been studied.
Danish: Sikkerheden af immunisering med levende virusvacciner under eller efter behandling med BLINCYTO er ikke undersøgt.
English: Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse reaction in the table above.
Danish: Bivirkningstermer, der repræsenterer samme medicinske begreb eller tilstand, er placeret i samme gruppe og rapporteret som en enkeltstående bivirkning i ovenstående tabel.
English: Patients should be observed closely for infusion reactions, especially during the initiation of the first and second treatment cycles and treated appropriately.
Danish: Patienterne skal observeres nøje for infusionsreaktioner, især i forbindelse med iværksættelse af første og anden behandlingscyklus, og behandles om nødvendigt.
English: Acute lymphoblastic leukaemia is a cancer of the blood in which a particular kind of white blood cell called “B-lymphocyte” is growing out of control.
Danish: Akut lymfoblastisk leukæmi er kræft i blodet, hvor en særlig type hvide blodlegemer, der kaldes for “B-lymfocytter”, vokser ukontrollerbart.
English: n = number of patients who achieved CR or CRh* in the first two cycles of treatment in the specified subgroup.
Danish: n = antal patienter, der opnåede CR eller CRh* i de første to behandlingscyklusser i den viste delgruppe.
English: If you are pregnant, are breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Danish: Hvis du er gravid, ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du tager dette lægemiddel.
English: To mitigate the risk of CRS, it is important to initiate BLINCYTO (cycle 1, days 1-7) at the recommended starting dose in section 4.2.
Danish: For at mindske risikoen for CRS er det vigtigt at initiere BLINCYTO (cyklus 1, dag 1-7) i den initialdosis, der anbefales under pkt.
English: Reinitiation of BLINCYTO at the correct therapeutic dose should be considered when all toxicities have resolved and no earlier than 12 hours after interruption of the infusion (see section 4.2).
Danish: Reinitiering af BLINCYTO ved den korrekte terapeutiske dosis skal overvejes, når alle toksiciteter er forsvundet og ikke tidligere end 12 timer efter afbrydelse af infusionen (se pkt.
English: Neurological toxicity
Danish: Neurologisk toksicitet
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis de ikke anvendes straks, er opbevaringstider og -betingelser efter åbning på brugerens ansvar og bør ikke være mere end 24 timer ved 2 °C - 8 °C, medmindre fortynding er sket under kontrollerede og validerede aseptiske betingelser.
English: The type of adverse events observed in infants were similar to those observed in the overall paediatric population.
Danish: Typen af bivirkninger, der blev observeret hos spædbørn, svarede til dem, der blev observeret i den generelle pædiatriske population.
English: The CR/CRh* for patients less than 2 years of age was 40% (4/10), for patients 2 to 6 years was 30.0% (6/20); and for patients aged 7 to 17 years was 25% (10/40).
Danish: CR/CRh* for patienter under 2 år var 40 % (4/10), for patienter i alderen 2 til 6 år var den 30,0 % (6/20), og for patienter i alderen 7 til 17 år var den 25 % (10/40).
English: Patients with prior allogeneic HSCT had similar response rates to those without prior HSCT, older patients had similar response rates to younger patients, and no substantial difference was observed in remission rates based on the number of lines of prior salvage treatment.
Danish: Patienter med tidligere allogen HSCT havde samme responsrater som patienter uden tidligere HSCT, ældre patienter havde samme responsrater som yngre patienter, og der blev ikke observeret nogen væsentlig forskel i remissionsraterne baseret på antal serier med tidligere livreddende behandling.
English: Add to the sodium chloride bag only.
Danish: Tilsættes kun i posen med natriumchlorid.
English: Your doctor may decide to then increase your dose for weeks 2, 3, and 4 of your treatment.
Danish: Derefter vil lægen muligvis beslutte at forhøje din dosis i uge 2, 3 og 4 af behandlingen.
English: BLINCYTO infusion bags should be prepared to infuse over 24 hours, 48 hours, 72 hours, or 96 hours.
Danish: Infusionsposerne med BLINCYTO skal klargøres til infusion i 24 timer, 48 timer, 72 timer eller 96 timer.
English: Overdoses have been observed including one patient who received 133-fold the recommended therapeutic dose of BLINCYTO delivered over a short duration.
Danish: Der er observeret overdosering, blandt andet hos en enkelt patient, der fik 133 gange den anbefalede terapeutiske dosis BLINCYTO, som blev tilført over kort tid.
English: Do not use this solution (stabiliser) for reconstitution of BLINCYTO powder for concentrate.
Danish: Brug ikke denne opløsning (stabilisator) til rekonstitution af BLINCYTO pulver til koncentrat.
English: 7.5 months [4.0 to 11.8 months]
Danish: 7,5 måneder [4,0 til 11,8 måneder]
English: BLINCYTO is used to treat children (≥ 1 year old), teenagers and young adults with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Danish: BLINCYTO anvendes til behandling af børn (≥ 1 år), teenagere og unge voksne med akut lymfoblastisk leukæmi (ALL), hvor tidligere behandlinger ikke har virket eller er holdt op med at virke.
English: This was a two-part study, a dose-finding part to determine the appropriate dosing regimen, followed by a single-arm efficacy part using this regimen.
Danish: Studiet var opdelt i to dele: en dosisfastlæggelsesdel til bestemmelse af et passende doseringsregime, efterfulgt af en effektdel med en enkelt behandlingsarm, som anvendte dette doseringsregime.
English: This is to account for intravenous infusion line loss and to assure that the patient will receive the full dose of BLINCYTO.
Danish: Dette er af hensyn til eventuelle tab i infusionsslangen og for at sikre, at patienten får hele dosen af BLINCYTO.
English: Patients should be closely monitored for signs or symptoms of TLS, including renal function and fluid balance in the first 48 hours after the first infusion.
Danish: Patienterne skal monitoreres nøje for tegn og symptomer på TLS, herunder kontrol af nyrefunktion og væskebalance, i de første 48 timer efter den første infusion.
English: If you have or had neurological problems, it is recommended that the first 14 days of treatment will be given to you in a hospital or clinic.
Danish: Hvis du har eller har haft neurologiske problemer, anbefales det, at du får de første 14 dages behandling på hospitalet eller en klinik.
English: The choice of the infusion duration should be made by the treating physician considering the frequency of the infusion bag changes.
Danish: Valget af infusionsvarighed skal træffes af den behandlende læge under hensyntagen til, hvor ofte infusionsposen skal skiftes.
English: It is very important that the instructions for preparation and administration provided in this section are strictly followed to minimise medication errors (including underdose and overdose).
Danish: Det er meget vigtigt, at instruktionerne til klargøring og administration, der findes i dette afsnit, følges nøje for at forebygge medicineringsfejl (inklusive underdosering og overdosering).
English: Rate and 95% Confidence Interval (CI)
Danish: Rate og 95 % konfidensinterval (CI)
English: No formal drug interaction studies have been performed.
Danish: Der er ikke udført formelle interaktionsstudier.
English: The active ingredient in BLINCYTO is blinatumomab.
Danish: Det aktive stof i BLINCYTO er blinatumomab.
English: In the second cycle, hospitalisation is recommended at a minimum for 2 days, and clinical judgment should be based on tolerance to BLINCYTO in the first cycle.
Danish: I den anden cyklus anbefales indlæggelse i mindst 2 dage, og den kliniske vurdering bør baseres på tolerancen over for BLINCYTO i den første cyklus.
English: • Obligation to complete post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: It is recommended that immunoglobulin levels are monitored in elderly patients during treatment with BLINCYTO.
Danish: Det anbefales at overvåge ældre patienters immunoglobulinniveauer under behandling med BLINCYTO.
English: In the dose-finding part of the study, doses of up to 30 mcg/m 2/day were evaluated.
Danish: I studiets dosisfastlæggelsesdel blev doser på op til 30 mikrog/m2/dag evalueret.
English: 12 Pyrexia includes body temperature increased and pyrexia.
Danish: 12 Pyreksi omfatter stigning i legemstemperatur og pyreksi.
English: Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof.
Danish: Skylning ved skift af pose eller ved afslutning af infusionen kan medføre en for stor dosis og deraf følgende komplikationer.
English: Transient elevation of cytokines was observed in the first two days following start of blinatumomab infusion.
Danish: Der blev observeret en forbigående stigning i cytokiner i de første to dage efter start af infusionen af blinatumomab.
English: Patients may receive 2 cycles of treatment.
Danish: Patienterne kan få 2 behandlingscyklusser.
English: Fifty percent (5/10) compared to 0% (0/5) achieved MRD response and 20% (2/10) compared to 40% (2/5) underwent allogeneic HSCT after treatment.
Danish: Halvtreds procent (5/10) sammenlignet med 0 % (0/5) opnåede MRD-respons, og 20 % (2/10) sammenlignet med 40 % (2/5) gennemgik allogen HSCT efter behandling.
English: Increase of T-cell counts above baseline (T-cell expansion) was observed in few patients.
Danish: En stigning i antal T-celler til niveauer over baseline (T-celle-ekspansion) blev observeret hos nogle få patienter.
English: The median OS was 15.6 months (CI 5.5 - not estimable) for the BLINCYTO group and 5.3 months (CI 1.1 - not estimable) for the SOC chemotherapy group.
Danish: Median OS var 15,6 måneder (CI 5,5 - kan ikke estimeres) for BLINCYTO-gruppen og 5,3 måneder (CI 1,1 - kan ikke estimeres) for SB kemoterapi-gruppen.
English: - prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Danish: - foregå i et aftræksskab med laminar strømning eller et biologisk sikkerhedsskab med anvendelse af standardforholdsreglerne for sikker håndtering af intravenøse midler.
English: In the first cycle, the initial dose was 9 mcg/day for week 1, then 28 mcg/day for the remaining 3 weeks.
Danish: I den første cyklus var initialdosen 9 mikrog/dag i uge 1 og derefter 28 mikrog/dag i de resterende 3 uger.
English: Your doctor may decide to then increase your dose to 28 micrograms per day for weeks 2, 3, and 4 of your treatment.
Danish: Derefter vil lægen muligvis beslutte at forhøje din dosis til 28 mikrogram om dagen i uge 2, 3 og 4 af behandlingen.
English: Days 29-42
Danish: Dag 29-42
English: o Ensure that the tubing is compatible with the infusion pump.
Danish: o Sørg for, at slangen er kompatibel med infusionspumpen.
English: These may include corticosteroids (e.g. dexamethasone).
Danish: Disse lægemidler kan blandt andet være kortikosteroider (fx dexamethason).
English: The starting volume (270 mL) is more than the volume administered to the patient (240 mL) to account for the priming of the intravenous tubing and to ensure that the patient will receive the full dose of BLINCYTO.
Danish: Startvolumen (270 ml) er mere end den volumen, der administreres til patienten (240 ml), for at tage højde for klargøringen af den intravenøse slange og for at sikre, at patienten får den fulde dosis af BLINCYTO.
English: The target dose of 28 mcg/day was administered in cycle 2 and subsequent cycles starting on day 1 of each cycle.
Danish: Måldosen på 28 mikrog/dag blev administreret i cyklus 2 og de efterfølgende cyklusser med start på dag 1 i hver cyklus.
English: If formation of anti-blinatumomab antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Danish: Hvis der er mistanke om dannelse af anti-blinatumomab-antistoffer med en klinisk signifikant virkning, skal indehaveren af markedsføringstilladelsen kontaktes for at drøfte eventuelle antistoftest.
English: Talk to your doctor or nurse about suitable methods of contraception.
Danish: Tal med lægen eller sundhedspersonalet om egnede præventionsformer.
English: Patients who have achieved complete remission (CR/CRh*) after 2 treatment cycles may receive up to 3 additional cycles of BLINCYTO consolidation treatment, based on an individual benefits-risks assessment.
Danish: Patienter, der har opnået komplet remission (CR/CRh*) efter 2 behandlingscyklusser, kan få op til yderligere 3 cyklusser med BLINCYTO konsolidationsbehandling, baseret på en individuel vurdering af fordele kontra risici.
English: • Pump specifications: The infusion pump to administer BLINCYTO solution for infusion should be programmable, lockable and have an alarm.
Danish: • Pumpespecifikationer: Infusionspumpen til administration af BLINCYTO infusionsvæske, opløsning, skal være programmerbar, låsbar og have en alarm.
English: In subsequent treatment cycles, cytokine elevation occurred in fewer patients with lesser intensity compared to the initial 48 hours of the first treatment cycle.
Danish: I de efterfølgende behandlingscyklusser forekom der stigninger i cytokiner hos færre patienter i mindre målestok sammenlignet med de første 48 timer i den første behandlingscyklus.
English: • infections in the blood including bacteria, fungi, viruses, or other types of infection
Danish: • infektioner i blodet, blandt andet bakterie-, svampe- eller virusinfektioner eller andre infektionstyper