FrancophonIA/ELRC3.0 huggingface dataset:
English: based on local site evaluations.
Danish: baseret på lokale evalueringer.
English: There are no data for children < 7 months of age.
Danish: Der er ingen data for børn < 7 måneder.
English: Some of these side effects may be serious.
Danish: Nogle af disse bivirkninger kan være alvorlige.
English: • if you have an active infection.
Danish: • Hvis du har en aktiv infektion.
English: b MedDRA high level group terms (MedDRA version 18.1).
Danish: MedDRA's high level group terms (MedDRA version 18.1).
English: Date of first authorisation: 23 November 2015 Date of last renewal: 19 April 2018
Danish: Dato for første markedsføringstilladelse: 23. november 2015 Dato for seneste fornyelse: 19. april 2018
English: Below lower limit of quantification Unknown
Danish: Under nedre grænse for kvantificering Ukendt
English: Do not try to restart your pump.
Danish: Du må ikke forsøge at genstarte pumpen.
English: Grade 3 is severe, and grade 4 is life-threatening.
Danish: Grad 3 er alvorlig, og grad 4 er livstruende.
English: * Based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Danish: * Baseret på NCI's Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
English: BLINCYTO may not be suitable for you:
Danish: BLINCYTO vil muligvis ikke være egnet til dig:
English: Kaplan-Meier curve of overall survival
Danish: Kaplan-Meier-kurve over samlet overlevelse
English: These changes reversed after cessation of treatment.
Danish: Disse ændringer forsvandt efter afbrydelse af behandlingen.
English: • Do not open the package.
Danish: • Du må ikke åbne pakningen.
English: • allergic reaction
Danish: • allergisk reaktion
English: You may also be given medicines to reduce fever.
Danish: Du vil muligvis også få lægemidler, der nedsætter feber.
English: Final interpretation of MRD results followed EuroMRD Consortium guidelines.
Danish: Den endelige fortolkning af MRD-resultater fulgte retningslinjerne fra EuroMRD Consortium.
English: Efficacy results from other key endpoints in the study are summarised in table 2.
Danish: Effektresultaterne fra andre vigtige endemål i studiet er opsummeret i tabel 2.
English: There is a possibility of a higher risk of neurologic events in this population.
Danish: Der er mulighed for forhøjet risiko for neurologiske hændelser i denne population.
English: BLINCYTO should not be used in children below 1 year of age.
Danish: BLINCYTO bør ikke anvendes til børn under 1 år.
English: Because the health-related quality of life results are based on a post-hoc sensitivity analysis, the results should be interpreted with caution.
Danish: Da resultaterne vedrørende helbredsrelateret livskvalitet er baseret på en post hoc-sensitivitetsanalyse, skal resultaterne fortolkes med forsigtighed.
English: The clinical significance of these imaging changes is unknown.
Danish: Den kliniske betydning af disse billeddiagnostiske ændringer er ukendt.
English: The primary endpoint was overall survival (OS).
Danish: Det primære endemål var den samlede overlevelse (OS).
English: These supplies are also required, but not included in the package
Danish: Disse materialer er også nødvendige, men følger ikke med i pakningen
English: BLINCYTO (cycle 1, day 1).
Danish: BLINCYTO (cyklus 1, dag 1).
English: Yes No
Danish: Ja Nej
English: Store at 2°C - 8°C if not used immediately.
Danish: Opbevares ved 2 °C - 8 °C, hvis det ikke bruges med det samme.
English: The infusion rate may be faster or slower depending on how often the bag is changed.
Danish: Infusionshastigheden kan være hurtigere eller langsommere, afhængigt af, hvor ofte posen skiftes.
English: You will then have a 2-week break where you will not be given the infusion.
Danish: Derefter får du en pause på 2 uger, hvor du ikke får nogen infusion.
English: Other instructions
Danish: Andre instruktioner
English: Extramedullary Disease at Baseline
Danish: Ekstramedullær sygdom ved baseline
English: Recommended daily dose by patient weight.
Danish: Anbefalet daglig dosis efter patientvægt.
English: Your doctor will discuss with you if you can continue treatment at home after your initial hospital stay.
Danish: Din læge vil tale med dig om, hvorvidt du kan fortsætte behandlingen derhjemme efter dit første ophold på hospitalet.
English: * Centrally assessed in an assay with minimum sensitivity of 10-4
Danish: * Centralt vurderet i analyse med en minimumssensitivitet på 10-4
English: If not diluted immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis den ikke fortyndes straks, er opbevaringstid og -betingelser på brugerens ansvar.
English: • confusion, disorientation
Danish: • forvirring, desorientering
English: Reconstituted BLINCYTO (number of packages)
Danish: Rekonstitueret BLINCYTO (antal pakninger)
English: This medicine works by enabling your immune system to attack and destroy these abnormal white blood cancer cells.
Danish: Dette lægemiddel virker ved at gøre dit immunsystem i stand til at angribe og ødelægge disse unormale hvide blodkræftceller.
English: The type and frequency of adverse events were similar across different paediatric sub-groups (gender, age, geographic region).
Danish: Typen og hyppigheden af bivirkninger var ens i de forskellige pædiatriske undergrupper (køn, alder, geografisk område).
English: In the event of overdose, the infusion should be temporarily interrupted and patients should be monitored.
Danish: I tilfælde af overdosering skal infusionen afbrydes midlertidigt, og patienten skal monitoreres.
English: d. n1: number of patients who achieved MRD response and the respective remission status; n2: number of patients who achieved the respective remission status.
Danish: d. n1: antallet af patienter, som opnåede MRD-respons og den tilhørende remissionsstatus; n2: antallet af patienter, som opnåede den tilhørende remissionsstatus.
English: 7 days if the toxicity does not recur.
Danish: 7 dage, hvis toksiciteten ikke vender tilbage.
English: Elastomeric pumps should not be used.
Danish: Der må ikke bruges elastomerpumper.
English: • if you have ever had an infusion reaction after previously using BLINCYTO.
Danish: • Hvis du tidligere har haft en infusionsreaktion efter at have brugt BLINCYTO.
English: • increased bilirubin in the blood
Danish: • forhøjet mængde bilirubin i blodet
English: Health related quality of life
Danish: Helbredsrelateret livskvalitet
English: Less than 45 kg (BSA-based dose)
Danish: Under 45 kg (BSA-baseret dosis)
English: (stabiliser).
Danish: (stabilisatoren).
English: • if the infusion pump stops unexpectedly.
Danish: • Infusionspumpen standser uventet.
English: Do not adjust the settings on the pump, even if there is a problem or the pump alarm sounds.
Danish: Du må ikke justere indstillingerne på pumpen - heller ikke selvom der opstår et problem, eller pumpens alarm går i gang.
English: Additionally, the side effects that happened more often in adolescents and children include:
Danish: Desuden forekom følgende bivirkninger oftere hos børn og unge:
English: ≥50% to <75%
Danish: ≥50% til <75%
English: Your doctor will discuss with you how long your treatment will last.
Danish: Din læge vil drøfte med dig, hvor længe behandlingen skal vare.
English: • 21-23 gauge needle(s) (recommended)
Danish: • 21-23 gauge kanyle(r) (anbefales).
English: Non-interventional post-authorisation safety study (PASS): Study 20150136: an observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices*
Danish: Ikke-interventionssikkerhedsstudie efter tilladelse til markedsføring (PASS): Studie 20150136: et observationsstudie af blinatumomabs sikkerhed og virkning, anvendelse og behandlingspraksisser*
English: The mean (SD) half-life was 2.11 (1.42) hours.
Danish: Den gennemsnitlige (SD) halveringstid var 2,11 (1,42) timer.
English: Your doctor will talk to you about precautions in using vaccinations for your baby.
Danish: Din læge vil tale med dig om forholdsregler for anvendelse af vaccinationer til dit barn.
English: *, 1 patient had progressive disease (OS 2.3 months) and 2 were non-responders (OS 1.1 months and 8.7 months, respectively).
Danish: *, 1 patient havde progredierende sygdom (OS 2,3 måneder) og 2 var non-respondere (OS henholdsvis 1,1 måned og 8,7 måneder).
English: The terms contributing to the relevant adverse reaction are indicated below:
Danish: De termer, der beskriver de relevante bivirkninger, er angivet nedenfor:
English: Any changes to the pump settings may result in a dose that is too high or too low.
Danish: Ændringer i pumpeindstillingerne kan betyde, at der gives en dosis, som er for høj eller for lav.
English: • chest pain or other pain
Danish: • brystsmerter eller andre smerter
English: Your doctor will check if you should have the vaccination.
Danish: Lægen vil finde ud af, om du bør få vaccinationen.
English: You should not use BLINCYTO during pregnancy, unless your doctor thinks that it is the best medicine for you.
Danish: Du må ikke bruge BLINCYTO under graviditet, medmindre din læge mener, at det er det bedst egnede lægemiddel til dig.
English: Clinical testing of MRD, regardless of the choice of technique, should be performed by a qualified laboratory familiar with the technique, following well established technical guidelines.
Danish: Klinisk test af MRD skal, uanset den valgte teknik, udføres af et kvalificeret laboratorie, som er bekendt med teknikken, og ifølge veletablerede tekniske retningslinjer.
English: Do not drive, use heavy machines, or engage in hazardous activities while you are being given BLINCYTO.
Danish: Lad være med at køre bil, bruge kraftige maskiner eller engagere dig i farlige aktiviteter, mens du får BLINCYTO.
English: Subsequent cycles
Danish: Efterfølgende cyklusser
English: Contact your doctor or nurse immediately if:
Danish: Kontakt straks din læge eller sundhedspersonalet, hvis:
English: From a microbiological point of view, the prepared infusion bags should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør de klargjorte infusionsposer anvendes straks.
English: There are no data from the use of blinatumomab in pregnant women.
Danish: Der er ingen data fra anvendelse af blinatumomab til gravide kvinder.
English: In this open-label study, Health related quality of life (HRQoL) reported by patients were measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30).
Danish: I dette åbne studie blev den helbredsrelaterede livskvalitet (HRQoL), som blev rapporteret af patienterne, målt ved hjælp af European Organization for Research and Treatment of Cancers Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30).
English: • Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: • Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Body surface area, gender and age
Danish: Legemsoverfladeareal, køn og alder
English: f. Only patients with HSCT in CR/CRh* remission (with no anti-leukemia agents used prior to HSCT) are included.
Danish: f. Kun patienter med HSCT i CR/CRh*-remission (uden anti-leukæmiske midler anvendt inden HSCT) er medtaget.
English: The demographics and baseline characteristics were well-balanced between the two arms (see table 1).
Danish: Demografi og baselinekarakteristika var velafbalancerede mellem de to behandlingsarme (se tabel 1).
English: • serious infection which can result in organ failure, shock or can be fatal (sepsis)
Danish: • alvorlig infektion, der kan medføre organsvigt eller shock eller kan være fatal (sepsis)
English: Complete remission (CR)
Danish: Komplet remission (CR)
English: 100-day mortality after alloHSCT
Danish: 100-dages mortalitet efter allo-HSCT
English: Sepsis Pneumonia
Danish: Sepsis Pneumoni
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: The dose of the concomitant medicinal product should be adjusted as needed.
Danish: Dosis af det samtidigt anvendte lægemiddel skal justeres efter behov.
English: Demographics and baseline characteristics in MRD study
Danish: Demografi og baseline-karakteristika i MRD-studie
English: Medicines given before each cycle of BLINCYTO
Danish: Lægemidler, der gives før hver cyklus af BLINCYTO
English: The potential benefits of treatment should be carefully weighed against the risk of neurologic events and heightened caution should be exercised when administering BLINCYTO to these patients.
Danish: De potentielle fordele ved behandlingen skal nøje opvejes mod risikoen for neurologiske hændelser, og der skal udvises øget forsigtighed ved administration af BLINCYTO til disse patienter.
English: For all subsequent cycle starts and reinitiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalisation is recommended.
Danish: I forbindelse med alle efterfølgende cyklusstarter og reinitiering (hvis for eksempel behandlingen afbrydes i 4 timer eller mere) anbefales opsyn af sundhedspersonale eller indlæggelse på hospitalet.
English: If you respond to this treatment, your doctor may decide to give you up to 3 additional cycles of treatment.
Danish: Hvis du reagerer på denne behandling, vil lægen muligvis beslutte, at du skal have op til yderligere 3 cyklusser.
English: Special instructions to support accurate preparation
Danish: Særlige instruktioner, der understøtter præcision i klargøringen
English: It is unknown whether blinatumomab or metabolites are excreted in human milk.
Danish: Det er ukendt, om blinatumomab/metabolitter udskilles i human mælk.
English: The median time to onset was 7.5 days.
Danish: Mediantiden indtil debut var 7,5 dage.
English: Caution should be exercised as cases of late occurrence of first neurological events have been observed.
Danish: Der skal udvises forsigtighed, da der er observeret tilfælde, hvor de første neurologiske hændelser er opstået sent.
English: Neurologic events including events with a fatal outcome have been observed.
Danish: Der er observeret neurologiske hændelser, herunder hændelser med fatalt udfald.
English: The median time to onset of a CRS event was 2 days.
Danish: Mediantiden indtil indtræden af CRS-hændelsen var 2 dage.
English: T-cell counts initially declined within 1 to 2 days and then returned to baseline levels within 7 to 14 days in the majority of patients.
Danish: Antal T-celler faldt indledningsvis inden for 1 til 2 dage og vendte derefter tilbage til niveauet ved baseline inden for 7 til 14 dage hos størstedelen af patienterne.
English: • Management of neurotoxicity (including dose adjustment and dose interruption)
Danish: • Behandling af neurotoksicitet (herunder dosisjustering og afbrydelse af dosering)
English: Six of those patients had anti-blinatumomab antibodies with in vitro neutralising activity.
Danish: Seks af disse patienter havde anti-blinatumomab-antistoffer med neutraliserende aktivitet in vitro.
English: If your leukaemia has spread to your brain and/or spinal cord, your doctor may have to treat this first before you can start treatment with BLINCYTO.
Danish: Hvis din leukæmi har spredt sig til din hjerne og/eller rygmarv, vil lægen muligvis være nødt til at behandle dette først, inden du kan starte i behandling med BLINCYTO.
English: Some vaccines must not be given within two weeks before, at the same time as or in the months after you receive treatment with BLINCYTO.
Danish: Nogle vacciner må ikke gives inden for 2 uger inden, samtidig med eller i månederne efter din behandling med BLINCYTO.
English: - The package will be opened by your nurse and the infusion bags will be stored in a refrigerator until infusion.
Danish: - Sygeplejersken vil åbne pakningen, og infusionsposerne vil blive opbevaret i et køleskab indtil infusionen.
English: Blinatumomab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Danish: Blinatumomab må ikke anvendes under graviditet, medmindre den potentielle fordel opvejer den potentielle risiko for fosteret.
English: - Do not freeze.
Danish: - Må ikke nedfryses.
English: This is particularly important when using an ambulatory infusion pump.
Danish: Dette er især vigtigt, hvis der bruges en transportabel infusionspumpe.
English: The number of treatment cycles and the dose which you will be given will depend on how you tolerate and respond to BLINCYTO.
Danish: Det antal behandlingscyklusser og den dosis, du vil få, afhænger af, hvor godt du tåler og reagerer på BLINCYTO.
English: * The study protocol needs to be developed and presented for PRAC review within 3 months after the EU Commission Decision.
Danish: * Studieprotokollen skal udarbejdes og præsenteres for PRAC til gennemgang inden for 3 måneder efter EuropaKommissionens beslutning.
English: The safety and efficacy of BLINCYTO in children < 1 year of age have not yet been established.
Danish: BLINCYTOs sikkerhed og virkning hos børn < 1 år er endnu ikke klarlagt.
English: There is limited experience with BLINCYTO in patients ≥ 75 years of age.
Danish: Der er begrænset erfaring med anvendelse af BLINCYTO til patienter på ≥ 75 år.
English: Headache Tremor
Danish: Hovedpine Tremor
English: Generally, safety was similar between elderly patients (≥ 65 years of age) and patients less than 65 years of age treated with BLINCYTO.
Danish: Generelt var sikkerheden ens hos ældre patienter (≥ 65 år) og patienter på under 65 år, der blev behandlet med BLINCYTO.
English: Due to the potential for progressive multifocal leukoencephalopathy (PML), patients should be monitored for signs and symptoms.
Danish: På grund af muligheden for progressiv multifokal leukoencefalopati (PML) skal patienterne monitoreres for tegn og symptomer.
English: Adverse reactions are presented below by system organ class and frequency category.
Danish: Bivirkningerne vises nedenfor, inddelt efter systemorganklasse og frekvens.
English: A central laboratory subsequently confirmed MRD levels by PCR.
Danish: Et centrallaboratorium bekræftede efterfølgende MRD-niveauer med PCR.
English: BLINCYTO powder (powder for concentrate): White to off-white powder.
Danish: BLINCYTO pulver (pulver til koncentrat): Hvidt til off-white pulver.
English: Recommended dose (for patients at least 45 kg in weight):
Danish: Anbefalet dosis (for patienter, der vejer mindst 45 kg):
English: 14-day treatment-free interval
Danish: 14 dages behandlingsfrit interval
English: Non-interventional post-authorisation safety study (PASS): The applicant should submit the final results of a follow-up observational study to further characterise the long-term safety of BLINCYTO including developmental aspects, HSCT and secondary malignancy in high-risk paediatric patients enrolled in Study 20120215*.
Danish: Ikke-interventionssikkerhedsstudie efter tilladelse til markedsføring (PASS): Ansøgeren skal indsende de endelige resultater af et opfølgende observationsstudie for yderligere at karakterisere den langsigtede sikkerhed af BLINCYTO, herunder udviklingsmæssige aspekter, HSCT og sekundær malignitet hos pædiatriske patienter med høj risiko, som deltager i studie 20120215*.
English: Specific reconstitution and dilution instructions are provided for each dose and infusion time.
Danish: Der er specifikke instruktioner til rekonstitution og fortynding for hver dosis og infusionstid.
English: ≥75% to <90%
Danish: ≥75 % til <90%
English: Forest plot of CR/CRh* rate during the first two cycles for study MT103-211 (primary analysis set)
Danish: Forest plot af CR/CRh*-rate i de første to cyklusser i studie MT103-211 (primært analysesæt)
English: Following continuous intravenous infusion, the steady state serum concentration (Css) was achieved within a day and remained stable over time.
Danish: Efter kontinuerlig intravenøs infusion blev serumkoncentrationen ved steady state (Css) nået inden for 1 døgn og forblev stabil over tid.
English: • The entire volume of the reconstituted and diluted BLINCYTO will be more than the volume to be administered to the patient (240 mL).
Danish: • Hele volumenen af rekonstitueret og fortyndet BLINCYTO vil være større end den volumen, der skal administreres til patienten (240 ml).
English: Neurologic events
Danish: Neurologiske hændelser
English: If an interruption due to an adverse event is longer than 7 days, start a new cycle.
Danish: Hvis en afbrydelse på grund af en bivirkning varer længere end 7 dage, startes en ny cyklus.
English: The median overall survival (OS) was 17.7 months (CI 3.1 - not estimable).
Danish: Den samlede medianoverlevelse (median-OS) var 17,7 måneder (CI 3,1 - kan ikke estimeres).
English: • high levels of some enzymes including blood enzymes
Danish: • høje niveauer af visse enzymer, blandt andet blodenzymer
English: In case of exposure during pregnancy, depletion of B-cells may be expected in newborns due to the pharmacological properties of the product.
Danish: I tilfælde af eksponering under graviditet kan der forventes depletering af B-celler hos nyfødte på grund af produktets farmakologiske egenskaber.
English: The majority of neurologic events (80.5 %) were clinically reversible and resolved following interruption of BLINCYTO.
Danish: Størstedelen af de neurologiske hændelser (80,5 %) var klinisk reversible og forsvandt efter afbrydelse af behandlingen med BLINCYTO.
English: The increase in mean Css values was approximately proportional to the dose in the range tested.
Danish: Stigningen i gennemsnitlige Css-værdier var omtrent proportionel med dosen inden for det afprøvede interval.
English: Tell your doctor immediately if you get any of the following or combination of the following side effects:
Danish: Fortæl det straks til lægen, hvis du får en eller flere af følgende bivirkninger eller en kombination af dem:
English: Results suggest that age (7 months to 80 years) and gender do not influence the pharmacokinetics of blinatumomab.
Danish: Resultaterne indikerer, at alder (7 måneder til 80 år) og køn ikke påvirker blinatumomabs farmakokinetik.
English: The infusion reactions were generally rapid, occurring within 48 hours after initiating infusion.
Danish: Infusionsreaktionerne opstod generelt hurtigt inden for 48 timer efter infusionens start.
English: Due to the potential for neurologic events, patients receiving blinatumomab should refrain from driving, engaging in hazardous occupations or activities such as driving or operating heavy or potentially dangerous machinery while blinatumomab is being administered.
Danish: På grund af muligheden for neurologiske hændelser skal patienter, der får blinatumomab, afstå fra at køre bil eller engagere sig i farlig beskæftigelse eller aktivitet, såsom at føre motorkøretøj eller betjene kraftige eller potentielt farlige maskiner, mens blinatumomab administreres.
English: Cytokines including IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α and IFN-γ were measured and, IL-6, IL-10 and IFN-γ were most elevated.
Danish: Der blev målt cytokiner, herunder IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α og IFN-γ, og IL-6, IL-10 og IFN-γ var mest forhøjede.
English: This should be followed by dexamethasone 5 mg/m orally or intravenously within 30 minutes prior to the start of
Danish: Dette bør efterfølges af dexamethason 5 mg/m oralt eller intravenøst inden for 30 minutter før påbegyndelse af
English: Prior to launch of BLINCYTO in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden lancering af BLINCYTO i hvert medlemsland skal indehaveren af markedsføringstilladelsen være enig med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: The effects of BLINCYTO in pregnant women are not known but based on its mechanism of action, BLINCYTO may harm your unborn baby.
Danish: Virkningerne af BLINCYTO på gravide kvinder kendes ikke, men baseret på BLINCYTOs virkningsmekanisme kan det skade det ufødte barn.