FrancophonIA/ELRC3.0 huggingface dataset:
English: • Add the reconstituted solution to an infusion container with sodium chloride 9 mg/mL (0.9%) solution for injection, to a total nominal volume of 50 mL.
Danish: • Kom den rekonstituerede opløsning i en infusionsbeholder med natriumchloridopløsning 9 mg/ml (0,9 %) til injektion, så det totale nominelle volumen er 50 ml.
English: Consider permanent discontinuation of BESPONSA.
Danish: Overvej permanent seponering af BESPONSA.
English: • are allergic to inotuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for inotuzumab ozogamicin eller et af de øvrige indholdsstoffer i BESPONSA (angivet i punkt 6).
English: All patients were required to have ≥ 5% bone marrow blasts and to have received 1 or 2 prior induction chemotherapy regimens for ALL.
Danish: Alle patienter skulle have ≥ 5% knoglemarvsblaster og tidligere have fået 1 eller 2 induktionskemoterapiregimer for ALL.
English: In patients with an inadequate bone marrow aspirate sample, a peripheral blood sample was tested.
Danish: Hos patienter med utilstrækkeligt knoglemarvaspirat blev der testet på en perifer blodprøve.
English: BESPONSA significantly increased the risk of VOD/SOS above that of standard chemotherapy regimens in this patient population.
Danish: BESPONSA øgede risikoen for VOD/SOS væsentligt i forhold til den risiko, der gælder for almindelige kemoterapiregimer hos denne patientgruppe.
English: VOD/SOS was reported up to 56 days after the last dose of inotuzumab ozogamicin without an intervening HSCT.
Danish: Der blev indberettet VOD/SOS op til 56 dage efter sidste dosis med inotuzumab ozogamicin uden intervenerende HSCT.
English: Based on non-clinical safety findings, inotuzumab ozogamicin can cause embryo-foetal harm when administered to a pregnant woman.
Danish: Baseret på ikkekliniske sikkerhedsfund kan inotuzumab ozogamicin forårsage embryoføtal skade, når det administreres til gravide kvinder.
English: Table 4 shows the dose modification guidelines depending on the duration of dosing interruptions due to toxicity.
Danish: Skema 4 viser retningslinjerne for dosisændring afhængigt af varigheden af doseringsafbrydelser, der skyldes toksicitet.
English: Inotuzumab ozogamicin (which has a density of 1.02 g/mL at 20 °C/68 °F) is light sensitive and should be protected from ultraviolet light during reconstitution, dilution, and administration.
Danish: Inotuzumab ozogamicin (som har en densitet på 1,02 g/ml ved 20 °C/68 °F) er lysfølsomt og skal beskyttes mod ultraviolet lys under rekonstituering, fortynding og administration.
English: Adverse reactions included treatment-emergent, all-causality events that commenced on, or after Cycle 1 Day 1 within 42 days after the last dose of BESPONSA, but prior to the start of a new anticancer treatment (including HSCT).
Danish: Bivirkninger inkluderede behandlingskrævende hændelser af alle årsager, der indtraf ved eller efter cyklus 1, dag 1, inden for 42 dage efter sidste dosis BESPONSA, men inden start på ny kræftbehandling (inklusive HSCT).
English: Table 8 shows the storage times and conditions for reconstitution, dilution, and administration of BESPONSA.
Danish: Skema 8 viser opbevaringstider og -forhold for rekonstituering, fortynding og administration af BESPONSA.
English: The table below shows the recommended dosing regimens.
Danish: Nedenstående skema viser de anbefalede doseringsregimer.
English: In animals, the primary target organs included the liver, bone marrow and lymphoid organs with associated haematological changes, kidney, and nervous system.
Danish: De primære målorganer hos dyr inkluderede leveren, knoglemarven og lymfoide organer med associerede hæmatologiske ændringer, nyrerne og nervesystemet.
English: Total bilirubin > 1.5 × ULN and AST/ALT > 2.5 × ULN
Danish: Total bilirubin > 1,5 × ULN og ASAT/ALAT > 2,5 × ULN
English: Treatment should be permanently discontinued if VOD/SOS occurs (see section 4.2).
Danish: Behandlingen skal seponeres permanent, hvis der forekommer VOD/SOS (se pkt.
English: Other observed changes included male and female reproductive organ effects (see below) and preneoplastic and neoplastic liver lesions
Danish: Andre observerede ændringer inkluderede påvirkning af reproduktionsorganerne hos hanner og hunner (se nedenfor) og præneoplastiske og neoplastiske leverlæsioner (se nedenfor).
English: Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agent, monoclonal antibodies, ATC code: L01XC26.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC26.
English: The relevance of these animal findings to humans is uncertain.
Danish: Relevansen for mennesker af disse fund hos dyr kendes ikke.
English: In humans, the total volume of distribution of inotuzumab ozogamicin was approximately 12 L.
Danish: Hos mennesker var det totale fordelingsvolumen af inotuzumab ozogamicin ca. 12 liter.
English: The maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) also resulted in foetal growth retardation, including decreased foetal weights and delayed skeletal ossification.
Danish: Den maternelle toksiske dosis (ca. 2,3 gange den kliniske eksponering hos mennesker baseret på AUC) resulterede også i væksthæmning hos fosteret, herunder lavere fostervægt og forsinket ossifikation af skelettet.
English: The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic product.
Danish: Det lille molekyle, N-acetyl-gamma-calicheamicin, er et cytotoksisk produkt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with BESPONSA in 1 or more subsets of the paediatric population for the treatment of relapsed or refractory ALL (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med BESPONSA i en eller flere undergrupper af den pædiatriske population i behandlingen af recidiverende eller refraktær ALL (se pkt.
English: - Protect from light.
Danish: - Beskyttes mod lys.
English: In patients who tested positive for anti-inotuzumab ozogamicin antibodies, no effect on clearance of BESPONSA was detected based on population-pharmacokinetic analysis.
Danish: Hos patienter, der blev testet positive for antistoffer mod inotuzumab ozogamicin, blev der ikke detekteret nogen indvirkning på clearance af BESPONSA baseret på populationsfarmakokinetisk analyse.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Headache (28%)
Danish: Hovedpine (28 %)
English: Infusion related reactions generally occurred in Cycle 1 and shortly after the end of the inotuzumab ozogamicin infusion and resolved spontaneously or with medical management.
Danish: Infusionsrelaterede reaktioner forekom generelt i cyklus 1 og kort efter endt infusion af inotuzumab ozogamicin, og de forsvandt spontant eller med medicinsk behandling.
English: The primary analysis of CR/CRi and MRD negativity was conducted in the initial 218 randomised patients and the analysis of OS, PFS, DoR, and HSCT rate was conducted in all 326 randomised patients.
Danish: Den primære analyse af CR/CRi og MRD-negativitet blev foretaget hos de første 218 randomiserede patienter, og analyse for OS, PFS, DoR, og HSCT-rate blev foretaget hos alle 326 randomiserede patienter.
English: Population pharmacokinetic/pharmacodynamic evaluation suggested a correlation between increasing inotuzumab ozogamicin serum concentrations and prolongation of QTc intervals in ALL and non-Hodgkin's lymphoma (NHL) patients.
Danish: Farmakokinetisk/farmakodynamisk populationsanalyse indikerede, at der var en korrelation mellem forøgede serumkoncentrationer af inotuzumab ozogamicin og forlængelse af QTc-intervaller hos patienter med ALL og patienter med non-Hodgkin lymfom (NHL).
English: In vitro, the binding of the N-acetyl-gamma-calicheamicin dimethylhydrazide to human plasma proteins is approximately 97%.
Danish: Bindingen in vitro af N-acetyl-gamma-calicheamicin dimethylhydrazid til humane plasmaproteiner er ca. 97 %.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket og kartonen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • 1 glass vial containing a white to off-white lyophilised cake or powder.
Danish: • 1 hætteglas indeholdende en hvid til råhvid frysetørret kage eller pulver.
English: • Reduced number of white blood cells which may result in general weakness and a tendency to develop infections
Danish: • Et lavere antal hvide blodlegemer, hvilket kan medføre generel svækkelse og en tendens til at udvikle infektion
English: HIDAC, FLAG, or MXN/Ara-C (N=109)
Danish: HIDAC, FLAG eller MXN/Ara-C (N = 109)
English: 2-sided p-value < 0.0001 BESPONSA (N=164)
Danish: 2-sidet p-værdi < 0,0001 BESPONSA (N = 164)
English: Five of the 18 VOD/SOS events that occurred post-HSCT were fatal (see section 5.1).
Danish: Fem ud af de 18 VOD/SOS-hændelser, der indtraf efter HSCT, var letale (se pkt.
English: Fatal infections, including pneumonia, neutropenic sepsis, sepsis, septic shock, and pseudomonal sepsis, were reported in 8 (5%) patients.
Danish: Der blev indberettet letale infektioner, herunder lungebetændelse, neutropenisk sepsis, sepsis, septisk shock og sepsis pseudomonas hos 8 (5 %) patienter.
English: Inotuzumab ozogamicin pharmacokinetics were well characterised by a 2-compartment model with linear and time-dependent clearance components.
Danish: Inotuzumab ozogamicins farmakokinetik er velkarakteriseret af en 2-kompartmentmodel med lineære og tidsbestemte clearance-komponenter.
English: Ask your doctor how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: In patients in whom the serum bilirubin is ≥ ULN prior to HSCT, HSCT post BESPONSA treatment should only be undertaken after careful consideration of the benefit/risk.
Danish: Hos patienter med serumbilirubin ≥ ULN inden HSCT må der kun fortsættes med HSCT efter behandling med BESPONSA efter nøje overvejelse af benefit/risk-forholdet.
English: Febrile neutropenia, which may be life-threatening, was reported in 43 (26%) patients.
Danish: Der blev indberettet febril neutropeni, som kan være livstruende, hos 43 (26 %) patienter.
English: Patients should be observed during, and for at least 1 hour after the end of infusion for symptoms of infusion related reactions (see section 4.4).
Danish: Patienter skal observeres under og i mindst 1 time efter endt infusion for symptomer på infusionsrelaterede reaktioner (se pkt.
English: • Protect the intravenous bag from light using an ultraviolet light-blocking cover (i.e., amber, dark brown, or green bags or aluminium foil) during infusion.
Danish: • Infusionsposen skal beskyttes mod lys ved hjælp af afskærmning, der beskytter mod ultraviolet lys (dvs. ravgule, mørkebrune eller grønne poser eller aluminiumsfolie) under infusion.
English: Inotuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody that specifically recognises human CD22.
Danish: Inotuzumab er et humaniseret immunoglobulin klasse G subtype 4 (IgG4) antistof, der specifikt genkender humant CD22.
English: HIDAC, FLAG, or MXN/Ara-C (N=162)
Danish: HIDAC, FLAG eller MXN/Ara-C (N = 162)
English: In 1 monkey, a focus of hepatocellular alteration was detected at approximately 3.1 times the human clinical exposure based on AUC at the end of the 26-week dosing period.
Danish: Hos 1 abe blev der detekteret ændring af et hepatocellulært focus ved ca. 3,1 gange den kliniske eksponering hos mennesker baseret på AUC ved afslutningen af den 26 uger lange doseringsperiode.
English: If particles or discolouration are observed, do not use.
Danish: Hvis der ses partikler eller misfarvning, må det ikke bruges.
English: Among the 79 patients who proceeded to a subsequent HSCT (8 of whom received additional salvage therapy after treatment with BESPONSA before proceeding to HSCT), VOD/SOS was reported in 18 (23%) patients.
Danish: Blandt de 79 patienter, som fortsatte med HSCT (hvoraf 8 fik yderligere behandling (salvage) efter behandling med BESPONSA inden fortsættelse med HSCT), blev der indberettet VOD/SOS hos 18 (23 %) patienter.
English: BESPONSA is for single use only.
Danish: BESPONSA er kun til engangsbrug.
English: • Gently invert the infusion container to mix the diluted solution.
Danish: • Vend forsigtigt infusionsbeholderen om for at blande den fortyndede opløsning.
English: Grade 3/4 TLS was reported in 3 (2%) patients.
Danish: Der blev indberettet grad 3/4 TLS hos 3 (2 %) patienter.
English: An increase in QTcF interval of > 450 msec was observed in 26/162 (16%) patients.
Danish: En stigning i QTcF intervallet på > 450 msek blev observeret hos 26/162 (16 %) patienter.
English: Based on a population pharmacokinetic analysis, age, race, and gender did not significantly affect inotuzumab ozogamicin disposition.
Danish: Baseret på populationsfarmakokinetisk analyse påvirker alder, race og køn ikke i betydelig grad fordelingen af inotuzumab ozogamicin.
English: Grade ≥ 2a non-haematological toxicity (BESPONSA-related)
Danish: a ikke-hæmatologisk toksicitet (BESPONSA-relateret)
English: Hyperbilirubinaemia (21%) Increased transaminases (26%) Increased GGT (21%)
Danish: Hyperbilirubinæmi (21 %) Forhøjede transaminaser (26 %) GGT-forhøjelse (21 %)
English: Based on a population pharmacokinetic analysis in 765 patients, body surface area was found to significantly affect inotuzumab ozogamicin disposition.
Danish: Populationsfarmakokinetisk analyse af 765 patienter indikerer, at legemsoverfladearealet påvirkede disposition af inotuzumab ozogamicin i betydelig grad.
English: The safety and efficacy of BESPONSA have not been studied in patients with end-stage renal disease.
Danish: BESPONSAs sikkerhed og virkning er ikke undersøgt hos patienter med nyresygdom i slutstadiet.
English: This included 70 and 18 patients in the BESPONSA and Investigator's choice of chemotherapy arm, respectively, who proceeded directly to HSCT.
Danish: Dette inkluderer 70 og 18 patienter i henholdsvis BESPONSA-armen og i behandlingsarmen med investigators valgs af kemoterapi som fortsatte direkte til HSCT.
English: No adjustment to the starting dose is required based on age (see section 5.2).
Danish: Det er ikke nødvendigt at justere startdosis ud fra alder (se pkt.
English: In all patients, liver tests should be monitored, including, ALT, AST, total bilirubin, and alkaline phosphatase, prior to and following each dose of BESPONSA.
Danish: Alle patienter skal have målt deres levertal, inklusive ALAT, ASAT, total bilirubin og alkalisk fosfatase inden og efter hver dosis BESPONSA.
English: In the event of an overdose, the infusion should be temporarily interrupted, and patients should be monitored for liver and haematological toxicities (see section 4.2).
Danish: I tilfælde af overdosering skal infusionen standses midlertidigt, og patienten skal kontrolleres for levertoksicitet og hæmatologisk toksicitet (se pkt.
English: - Patients who have experienced prior confirmed severe or ongoing venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS).
Danish: - Patienter, der tidligere har haft bekræftet svær eller aktiv veno-okklusiv leversygdom/sinusoidalt obstruktionssyndrom (VOD/SOS).
English: Your doctor will take an electrocardiogram (ECG) and blood tests to measure electrolytes (e.g., calcium, magnesium, potassium) before the first dose of BESPONSA and repeat these tests during treatment.
Danish: Lægen tager et EKG (elektrokardiogram) og blodprøver for at måle elektrolytterne i blodet (fx calcium, magnesium, kalium) inden den første dosis BESPONSA, og regelmæssigt under behandlingen.
English: CR/CRi and MRD negativity findings in the initial 218 randomised patients were consistent with those seen in all 326 randomised patients.
Danish: Fund vedrørende CR/CRi- og MRD-negativitet fra de første 218 randomiserede patienter stemte overens med de resultater, der sås hos alle 326 randomiserede patienter.
English: • have elevations in amylase or lipase enzymes that may be a sign of problems with your pancreas or liver and gallbladder or bile ducts.
Danish: • har forhøjet indhold af amylase eller lipaseenzymer, hvilket kan være et tegn på problemer med bugspytkirtlen eller leveren og galdeblæren eller galdegangene.
English: Management of severe infection, bleeding/haemorrhage and other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require a dosing interruption, dose reduction, or discontinuation of treatment (see section 4.2).
Danish: Behandling af svær infektion, blødning/hæmoragi og andre virkninger af myelosuppression, herunder svær neutropeni eller trombocytopeni, kan kræve midlertidig afbrydelse af behandlingen, nedsættelse af dosis eller seponering (se pkt.
English: Therefore, the concomitant use of inotuzumab ozogamicin with medicinal products known to prolong QT interval or to induce Torsades de Pointes should be carefully considered.
Danish: Derfor bør man nøje overveje samtidig brug af inotuzumab ozogamicin og lægemidler, der er kendt for at forlænge QT-intervallet eller fremkalde Torsades de Pointes.
English: In the pivotal clinical study (N=164), VOD/SOS was reported in 23 (14%) patients including 5 (3%) patients during study therapy or in follow-up without an intervening HSCT.
Danish: I det kliniske pivotalstudie (N = 164) blev der indberettet VOD/SOS hos 23 (14 %) patienter herunder 5 (3 %) patienter under studiebehandlingen eller under opfølgning uden intervenerende HSCT.
English: No formal clinical drug interaction studies have been performed (see section 5.2).
Danish: Der er ikke udført interaktionsundersøgelser (se pkt.
English: In toxicity studies, rats developed oval cell hyperplasia, altered hepatocellular foci, and hepatocellular adenomas in the liver at approximately 0.3 times the human clinical exposure based on AUC.
Danish: I toksicitetsstudier udviklede rotter ovalcellehyperplasi, ændrede hepatocellulære foci og hepatocellulære adenomer i leveren ved ca. 0,3 gange den kliniske eksponering hos mennesker baseret på AUC.
English: Table 2 and Table 3 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Danish: Skema 2 og Skema 3 viser retningslinjer for dosisændring ved hhv. hæmatologisk og ikkehæmatologisk toksicitet.
English: In the pivotal study (N=164), infusion related reactions were reported in 17 (10%) patients.
Danish: I pivotalstudiet (N = 164) blev der indberettet infusionsrelaterede reaktioner hos 17 (10 %) patienter.
English: BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22positive B cell precursor acute lymphoblastic leukaemia (ALL).
Danish: BESPONSA er indiceret som monoterapi til behandling af voksne med recidiverende eller refraktær CD22-positiv B-celle prækursor akut lymfoblastær leukæmi (ALL).
English: Dosing regimen for Cycle 1 and subsequent cycles depending on response to treatment
Danish: Doseringsregime for cyklus 1 og efterfølgende cyklusser afhængig af respons på behandlingen
English: Dose modification(s)
Danish: Dosisændring(er)
English: In patients who underwent a follow-up HSCT, the median OS was 11.9 months (95% CI: 9.2, 20.6) for BESPONSA versus 19.8 months (95% CI: 14.6, 26.7) for Investigator's choice of chemotherapy.
Danish: Hos patienter, som fik en opfølgende HSCTbehandling, var den mediane OS 11,9 måneder (95% CI: 9,2-20,6) for BESPONSA versus 19,8 måneder (95% CI: 14,6-26,7) for investigators valg af kemoterapi.
English: Use appropriate aseptic technique for the reconstitution and dilution procedures.
Danish: Anvend aseptisk teknik under rekonstituering og fortynding.
English: No patients tested positive for neutralising anti-inotuzumab ozogamicin antibodies.
Danish: Ingen patienter blev testet positiv for neutraliserende antistoffer mod inotuzumab ozogamicin.
English: There are no data in pregnant women using inotuzumab ozogamicin.
Danish: Der foreligger ingen data fra gravide kvinder, der bruger inotuzumab ozogamicin.
English: Do not use BESPONSA if you:
Danish: Brug ikke BESPONSA:
English: a, b, c, d, e, f For definition, see Table 6 (with the exception that CR/CRi was not per EAC for Study 2)
Danish: Se skema 6 for definitioner (med undtagelsen at CR/Cri ikke var per EAC i studie 2)
English: g Duration of remission was defined as the time since first response of CRa or CRib per Investigator's assessment to the date of a PFS event or censoring date if no PFS event was documented.
Danish: a- eller CRi b-respons ifølge investigators vurdering til datoen for en PFS-hændelse eller censureringsdatoen, hvis der ikke blev dokumenteret en PFShændelse.
English: In 234 patients with relapsed or refractory ALL, the clearance of inotuzumab ozogamicin at steady state was 0.0333 L/h, and the terminal elimination half-life (t½) at the end of Cycle 4 was approximately 12.3 days.
Danish: Clearance af inotuzumab ozogamicin ved steady state hos 234 patienter med recidiverende eller refraktær ALL var 0,0333 l/t, og den endelige halveringstid (t½) ved afslutningen af cyklus 4 var ca. 12,3 dage.
English: Among all 326 randomised patients, the survival probability at 24 months was 22.8% in the BESPONSA arm and 10% in the Investigator's choice of chemotherapy arm.
Danish: Blandt alle 326 randomiserede patienter var sandsynligheden for overlevelse efter 24 måneder 22,8 % i inotuzumab BESPONSA-armen og 10 % i behandlingsarmen med investigators valg af kemoterapi.
English: No Grade ≥ 3 QT interval prolongation or events of Torsades de Pointes were reported.
Danish: Der blev ikke indberettet forlænget QT-interval af grad ≥ 3 eller Torsades de Pointes.
English: Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Danish: Aktivering af N-acetyl-gamma-calicheamicin dimethylhydrazid inducerer dobbeltstrengede brud på DNA, hvorefter stop af cellecyklus og apoptotisk celledød induceres.
English: This medicine should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Dette lægemiddel skal efterses visuelt for partikler og misfarvning før det gives.
English: CD22 expression was assessed using flow cytometry based on bone marrow aspirate.
Danish: CD22-ekspression blev vurderet ved hjælp af flowcytometri baseret på knoglemarvsaspirat.
English: • Reconstitute each 1 mg vial with 4 mL of water for injection, to obtain a single-use solution of 0.25 mg/mL of BESPONSA.
Danish: • Rekonstituér hvert 1 mg hætteglas med 4 ml vand til injektionsvæske for at få en engangsopløsning på 0,25 mg/ml BESPONSA.
English: However, if the diluted solution is filtered, polyethersulphone (PES)-, polyvinylidene fluoride (PVDF)-, or hydrophilic polysulphone (HPS)-based filters are recommended.
Danish: Hvis den fortyndede opløsning imidlertid filtreres, anbefales det at anvende polyethersulfon (PES)-, polyvinylidenfluorid (PVDF)- eller hydrofile polysulfon (HPS)-baserede filtre.
English: a +/- 2 days (maintain minimum of 6 days between doses).
Danish: +/- 2 dage (oprethold minimum 6 dage mellem doser).
English: Depending on the severity of the infusion related reaction, consider discontinuation of the infusion or administration of steroids and antihistamines.
Danish: Afhængigt af hvor alvorlig den infusionsrelaterede reaktion er, bør det overvejes at stoppe infusionen eller at administrere steroider og antihistaminer.
English: 2-sided p-value = 0.0022
Danish: 2-sidet p-værdi = 0,0022