FrancophonIA/ELRC3.0 huggingface dataset:
English: If a diagnosis of PML is suspected Arzerra should be discontinued and referral to a neurologist should be considered.
Danish: Hvis der er mistanke om PML, skal Arzerra seponeres, og henvisning af patienten til neurolog bør overvejes.
English: Cycle 1 61.4 3560
Danish: Cyklus 1 61,4 3.560
English: Table 2 Summary of secondary outcomes of Arzerra in combination with chlorambucil compared with chlorambucil in previously untreated CLL
Danish: Tabel 2 Sammenfatning af sekundære resultater af Arzerra i kombination med chlorambucil sammenlignet med chlorambucil hos tidligere ubehandlede CLL
English: Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL.
Danish: Arzerra er i kombination med fludarabin og cyclophosphamid indiceret til behandling af voksne patienter med recidiverende CLL.
English: The remaining infusions will then be given once a month for up to 11 months.
Danish: De resterende infusioner vil blive givet en gang om måneden i op til 11 måneder.
English: The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed doubling the rate every 30 minutes).
Danish: Infusionshastigheden kan fortsat øges i henhold til standardprocedurer, lægens skøn og patientens tolerance (dog må hastigheden ikke øges med mere end en fordobling hvert 30. minut).
English: When ofatumumab was administered in combination with chlorambucil in patients with previously untreated CLL, the median decreases in B-cell counts after the first cycle and prior to the sixth monthly cycle were 94% and >99%.
Danish: Når ofatumumab blev administreret i kombination med chlorambucil til patienter med tidligere ubehandlet CLL var det mediane fald i antallet af B-celler efter første cyklus og før den sjette månedlige cyklus 94 % og >99 %.
English: Table 1 Summary of PFS with Arzerra in combination with chlorambucil compared with chlorambucil in previously untreated CLL
Danish: Tabel 1 Sammenfatning af PFS med Arzerra i kombination med chlorambucil sammenlignet med chlorambucil i tidligere ubehandlet CLL
English: Arzerra in combination with chlorambucil showed a statistically significant (71%) improvement in median PFS compared with chlorambucil alone (HR: 0.57; 95% CI: 0.45, 0.72) (see Table 1 and Figure 1).
Danish: Azarra i kombination med chlorambucil viste en statistisk signifikant forbedring i gennemsnitlig PFS på (71 %) sammenlignet med chlorambucil alene (HR: 0,57; 95 % konfidensinterval: 0,45; 0,72) (se tabel 1 og figur 1).
English: Overall, the pharmacokinetics of ofatumumab were consistent across the indications, whether given as a single agent or in combination with fludarabine and cyclophosphamide or chlorambucil.
Danish: Ofatumumumabs farmakokinetik var overordnet i overensstemmelse på tværs af indikationer, og uanset om det administreret alene eller i kombination med fludarabine og cyclophosphamid eller chlorambucil.
English: Thirteen (7%) patients treated with ofatumumab in combination with fludarabine and cyclophosphamide, and 5 (3%) patients treated with fludarabine and cyclophosphamide had late-onset neutropenia.
Danish: 13 patienter (7 %) behandlet med ofatumumab i kombination med fludarabin og cyclophosphamid og 5 patienter (3 %) behandlet med fludarabin og cyclophosphamid havde sent indsættende neutropeni.
English: It is recommended that patients have electrolytes such as potassium and magnesium measured prior to and during the administration of ofatumumab.
Danish: Det anbefales, at patienterne får målt elektrolytter, såsom kalium og magnesium, før og under behandling med ofatumumab.
English: Of the 1,168 patients receiving ofatumumab in clinical trials for CLL, 682 patients (58%) experienced an infection.
Danish: Ud af de 1.168 patienter, der fik ofatumumab i de kliniske studier af CLL, fik 682 patienter (58 %) en infektion.
English: In addition, the binding of ofatumumab allows the recruitment of natural killer cells allowing the induction of cell death through antibody-dependent cell-mediated cytotoxicity.
Danish: Derudover muliggør bindingen af ofatumumab rekruttering af NK-celler (natural killer cells), hvorved celledød induceres via antistofafhængig, cellemedieret cytotoksicitet.
English: Of the 1,168 patients receiving ofatumumab in clinical trials, 420 patients (36%) experienced an adverse event associated with a decreased neutrophil count; 129 (11%) experienced a serious adverse event associated with a decreased neutrophil count.
Danish: Ud af de 1.168 patienter, der fik ofatumumab i de kliniske studier, fik 420 (36 %) en bivirkning forbundet med nedsat neutrofiltal; 129 (11 %) fik en alvorlig bivirkning forbundet med nedsat antal neutrofiler.
English: Ofatumumab has also been shown to induce cell lysis in both high and low CD20 expressing cells and in rituximabresistant cells.
Danish: Det har også vist sig, at ofatumumab både inducerer lysering af celler, der udtrykker høje og lave niveauer af CD20, og lysering af rituximab-resistente celler.
English: There were no fatal infusionrelated reactions (see section 4.4).
Danish: Der var ingen infusionsrelaterede reaktioner med dødelig udgang (se pkt.
English: What Arzerra looks like and contents of the pack Arzerra is a colourless to pale yellow concentrate for solution for infusion.
Danish: Udseende og pakningsstørrelser Arzerra er et farveløst til svagt gult koncentrat til infusionsvæske.
English: Infusion-related reactions occur predominantly during the first infusion and tend to decrease with subsequent infusions.
Danish: Der opstår hovedsagelig infusionsrelaterede reaktioner under den første infusion, og risikoen aftager som regel ved de efterfølgende infusioner.
English: Check with your doctor if you think any of these may apply to you.
Danish: Tal med lægen, hvis du mener, at noget af ovenstående gælder for dig.
English: Infections and Infestations
Danish: Infektioner og parasitære sygdomme
English: If the infusion rate had not been increased from the starting rate of 12 ml/hour prior to interrupting due to an ADR, the infusion should be restarted at 12 ml/hour, the standard starting infusion rate.
Danish: Hvis infusionshastigheden ikke blev øget fra den initiale hastighed på 12 ml/time, før infusionen blev afbrudt på grund af en bivirkning, bør infusionen genoptages med en hastighed på 12 ml/time, som er den initiale standardinfusionshastighed.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Udslæt*
English: When ofatumumab was administered in combination with fludarabine and cyclophosphamide in patients with relapsed CLL, the median decrease from baseline was 60% after the first infusion and complete depletion (100%) was reached after 4 cycles.
Danish: Når ofatumumab blev administreret i kombination med fludarabin og cyclophosphamid til patienter med recidiverende CLL, blev medianen reduceret med 60 % fra baseline efter første infusion og fuldstænding depletering (100 %) blev nået efter 4 cyklusser.
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 2-8 ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Opbevaringstiden er normalt ikke længere end 24 timer ved 2-8 ºC, medmindre rekonstitutionen/fortyndingen er sket under kontrollerede og godkendte aseptiske forhold.
English: For patients who show evidence of prior (HBsAg negative, anti-HBc positive) hepatitis B infection, physicians with expertise in managing hepatitis B should be consulted regarding monitoring and initiation of HBV antiviral therapy.
Danish: Hos patienter, der viser tegn på tidligere hepatitis B-infektion (HBsAgnegativ, anti-HBc-positiv), skal læger med erfaring inden for hepatitis B konsulteres angående monitorering og iværksættelse af antiviral behandling af HBV.
English: Refractory CLL:
Danish: Refraktær CLL:
English: • excessive sweating
Danish: • kraftig sveden
English: Of the 1,168 patients receiving ofatumumab in clinical trials for CLL, the most frequently observed ADRs were infusion-related reactions which occurred in 711 patients (61%) at any time during treatment.
Danish: Af de 1.168 patienter, der fik ofatumumab i kliniske studier af CLL, var infusionsreaktioner de hyppigst forekommende bivirkninger, og forekom hos 711 patienter (61%) på et eller andet tidspunkt i behandlingsforløbet.
English: One ml contains 20 mg ofatumumab.
Danish: Én ml indeholder 20 mg ofatumumab.
English: Agranulocytosis, coagulopathy, red cell aplasia, lymphopenia
Danish: Agranulocytose, koagulopati, erytrocytaplasi, lymfopeni
English: Nine patients (4%) treated with ofatumumab and chlorambucil, and three patients treated with chlorambucil alone had late-onset neutropenia (defined as Grade 3 or 4 neutropenia starting at least 42 days after the last treatment).
Danish: 9 patienter (4 %), der blev behandlet med ofatumumab og chlorambucil, og 3 patienter, som blev behandlet med chlorambucil alene, havde sen debut af neutropeni (defineret som netropeni af grad 3 eller 4 med debut tidligst 42 dage efter den sidste behandling).
English: Hypersensitivity to ofatumumab or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for ofatumumab eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Study OMB110913 (randomised, open-label, parallel-arm, multicentre trial) evaluated the efficacy of ofatumumab in combination with fludarabine and cyclophosphamide compared with fludarabine and cyclophosphamide in 365 patients with relapsed CLL (defined as a patient who has received at least one prior CLL therapy and previously achieved a complete or partial remission/response, but after a period of six or more months demonstrated evidence of disease progression).
Danish: Studie OMB110913 (et randomiseret, åbent multicenter-forsøg med parallelle arme) sammenlignede effekten af ofatumumab plus fludarabin og cyclophosphamid med fludarabin og cyclophosphamid hos 365 patienter med recidiverende CLL (defineret som en patient, der har fået mindst én tidligere behandling for CLL, og som tidligere har opnået komplet eller partiel remission/respons, men efter en periode på seks måneder eller mere viste tegn på sygdomsprogression).
English: Effects on male and female fertility have not been evaluated in animal studies.
Danish: Effekten på hanner og hunners fertilitet er ikke blevet undersøgt i dyreforsøg.
English: CL (ml/h)
Danish: CL (ml/t)
English: Study OMB110911 (randomised, open-label, parallel-arm, multicentre) evaluated the efficacy of Arzerra in combination with chlorambucil compared with chlorambucil alone in 447 patients with previously untreated CLL considered inappropriate for fludarabine-based treatment (e.g. due to advanced age or presence of co-morbidities), with active disease and indicated for treatment.
Danish: Studie OMB110911 (randomiseret, open-label, parallel-arm, multicenter) evaluerede effekten af Arzerra i kombination med chlorambucil sammenlignet med chlorambucil alene hos 447 patienter med tidligere ubehandlet CLL, som var vurderet uegnede til fludarabinbaseret behandling (f.eks. på grund af fremskreden alder eller forekomst af komorbiditet), med aktiv sygdom og indiceret til behandling.
English: Hazard Ratio=0.67 95% CI (0.51,0.88) p-value=0.0032
Danish: Hazard Ratio=0,67 95% CI (0,51, 0,88) p-værdi=0,0032
English: Arzerra is indicated for the treatment of CLL in adult patients who are refractory to fludarabine and alemtuzumab.
Danish: Arzerra er indiceret til behandling af voksne patienter med CLL, der er refraktære over for fludarabin og alemtuzumab.
English: Ofatumumab should be a colourless to pale yellow solution.
Danish: Ofatumumab bør være en farveløs til svagt gul opløsning.
English: Pulmonary oedema*, hypoxia*
Danish: Lungeødem*, hypoksi*
English: The overall response rate (ORR) was also assessed by an IRC using the 2008 NCI-WG guidelines.
Danish: Den overordnede responsrate (ORR) blev også vurderet af en IRC ved hjælp af 2008 NCI-WGguidelines.
English: What you need to know before you are given Arzerra
Danish: Det skal du vide, før du får din behandling med Arzerra
English: For relapsed CLL, the recommended dosage and schedule is:
Danish: Ved recidiverende CLL er den anbefalede dosis og doseringsskema:
English: Before diluting Arzerra
Danish: Inden fortynding af Arzerra
English: VIAL LABEL
Danish: HÆTTEGLAS ETIKET
English: An open-label, two arm, randomised study (OMB114242) was conducted in patients with bulky fludarabine refractory CLL who had failed at least 2 prior therapies (n=122) comparing Arzerra monotherapy (n=79) to physicians' choice (PC) of therapy (n=43).
Danish: Et åbent, to-armet, randomiseret studie (OMB114242) blev udført med fludarabin-refraktære CLLpatienter med stor tumorbyrde, hvor mindst 2 tidligere behandlingsregimer var mislykkedes (n=122); i studiet blev Arzerra-monoterapi (n=79) sammenlignet med lægens behandlingsvalg (n=43).
English: In the event of a severe infusion-related reaction, the infusion of Arzerra must be interrupted immediately and symptomatic treatment instituted (see section 4.2).
Danish: I tilfælde af en alvorlig infusionsrelaterede reaktion, skal infusionen af Arzerra omgående afbrydes og symptomatisk behandling iværksættes (se pkt.
English: Febrile neutropenia, thrombocytopenia,
Danish: Febril neutropeni, trombocytopeni, leukopeni
English: When ofatumumab was administered as single agent in patients with refractory CLL, the median decrease in B-cell counts was 22% after the first infusion and 92% at the eighth weekly infusion.
Danish: Når ofatumumab blev administreret alene til patienter med refraktær CLL var medianen af faldet i Bcelletallet 22 % efter den første infusion og 92 % ved den ottende ugentlige infusion.
English: • Cycle 1: 300 mg on day 1 followed 1 week later by 1000 mg on day 8
Danish: • Cyklus 1: 300 mg på dag 1 efterfulgt en uge senere af 1000 mg på dag 8.
English: • the bone marrow failing to produce enough red or white blood cells
Danish: • utilstrækkelig produktion af røde eller hvide blodlegemer i knoglemarven.
English: • blockage in the gut (intestine), which may feel like stomach pain.
Danish: • forstoppelse, hvilket kan føles som mavesmerter.
English: Resumption of Arzerra in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing hepatitis B.
Danish: Genoptagelse af Arzerra hos patienter, hvis HBV-reaktivering falder til ro, skal diskuteres med en læge med erfaring i behandling af hepatitis B.
English: Hazard Ratio=0.57 95% CI (0.45, 0.72) p-value<0.001
Danish: Hazard Ratio=0,57 95% CI (0,45, 0,72) p-værdi<0,001
English: However, patients with hepatic impairment are unlikely to require dose modification (see section 5.2).
Danish: Det er dog usandsynligt, at der kræves dosisjustering til patienter med nedsat leverfunktion (se pkt.
English: Cytopenias, including prolonged and late-onset neutropenia, have been reported during ofatumumab therapy.
Danish: Cytopenier, herunder forlænget og sen debut af neutropeni, er set under behandling med ofatumumab.
English: Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in those who are hepatitis B core antibody (anti-HBc) positive but HBsAg negative.
Danish: Der er rapporteret tilfælde hos patienter, der er hepatitis B-overfladeantigen (HBsAg)-positive og også hos patienter, der er hepatitis B-kerneantistof (anti-HBc)-positive, men HBsAg-negative.
English: For patients with missing baseline data, latest screening/unscheduled data was carried forward to baseline.
Danish: Hvis der ikke forelå data ved udgangsniveauet om patienterne, blev de nyeste data fra screeningen/uplanlagte undersøgelser overført til udgangsniveauet.
English: Discontinuation of HBV antiviral therapy should be discussed with physicians with expertise in managing hepatitis B.
Danish: Seponering af antiviral HBV-behandling skal diskuteres med en læge med erfaring i behandling af hepatitis B.
English: Breast-feeding is not recommended during treatment with Arzerra and for 12 months after the last dose.
Danish: Det frarådes at amme under behandlingen med Arzerra og i 12 måneder efter den sidste dosis.
English: The safe use of ofatumumab in humans during lactation has not been established.
Danish: Sikkerheden ved brug af ofatumumab under amning er ikke påvist.
English: They are more likely during the first treatment.
Danish: Det er mest sandsynligt, at de forekommer i forbindelse med den første infusion.
English: Administer using an intravenous infusion pump.
Danish: Lægemidlet administreres ved brug af en pumpe til intravenøs infusion.
English: The primary endpoint of progression-free survival (PFS), as assessed by a blinded independent review committee (IRC) using the updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008), was prolonged in the ofatumumab plus fludarabine-cyclophosphamide (OFA+FC) arm compared to the fludarabine-cyclophosphamide (FC) arm (28.9 months versus 18.8 months; HR: 0.67; 95% CI: 0.51-0.88, p=0.0032) resulting in a 10-month improvement in median PFS (see Figure 2).
Danish: Det primære endepunkt progressionsfri overlevelse (PFS), vurderet af en blindet, uafhængig vurderingskomité (IRC) ved brug af de opdaterede National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008), var forlænget i armen med ofatumumab plus fludarabin og cyclophosphamid (OFA+FC) sammenlignet med armen med fludarabin og cyclophosphamid (FC) (28,9 måneder versus 18,8 måneder; HR: 0,67; 95 % konfidensinterval: 0,51-0,88; p=0,0032), hvilket resulterede i en forbedring i median-PFS på 10 måneder (se figur 2).
English: • sore throat, feeling of pressure or pain in the cheeks and forehead, infections of the ear, nose or throat.
Danish: • ondt i halsen, følelsen af trykken eller smerte i kinder og panden, øre-, næse- eller
English: In the pivotal study (OMB110913, ofatumumab plus fludarabine and cyclophosphamide 181 patients; fludarabine and cyclophosphamide 178 patients) in relapsed CLL patients, prolonged neutropenia was reported in 38 (11%) patients (18 patients [10%] treated with ofatumumab in combination with fludarabine and cyclophosphamide compared to 20 patients [11%] in the fludarabine and cyclophosphamide arm).
Danish: I det pivotale studie (OMB110913, 181 patienter fik ofatumumab samt fludarabin og cyclophosphamid; 178 patienter fik fludarabin og cyclophosphamid) med patienter med recidiverende CLL blev der set forlænget neutropeni hos 38 patienter (11 %) (18 patienter [10 %] behandlet med ofatumumab i kombination med fludarabin og cyclophosphamid sammenlignet med 20 patienter [11 %] i armen med fludarabin og cyclophosphamid).
English: Also contains: arginine, sodium acetate (E262), sodium chloride, polysorbate 80 (E433), edetate disodium (E386), hydrochloric acid (E507), water for injections.
Danish: Indeholder også: arginin, natriumacetat (E262), natriumchlorid, polysorbat 80 (E433), dinatriumedetat (E386), saltsyre (E507), vand til injektionsvæsker.
English: Any unused solution remaining after this time should be discarded.
Danish: Eventuel ubrugt opløsning, der er tilovers efter dette tidspunkt, skal kasseres.
English: • difficulty in breathing, shortness of breath, chest tightness, cough
Danish: • vejrtrækningsbesvær, åndenød, trykkende fornemmelse i brystet, hoste
English: In the pivotal study for untreated CLL (OMB110911; ofatumumab plus chlorambucil 217 patients, chlorambucil alone 227 patients), prolonged neutropenia (defined as Grade 3 or 4 neutropenia not resolved between 24 and 42 days after last dose of study treatment) was reported in 41 patients (9%) (23 patients [11%] treated with ofatumumab and chlorambucil, 18 patients [8%] treated with chlorambucil alone).
Danish: I det pivotale studie med ubehandlede CLL-patienter (OMB110911; 217 patienter fik ofatumumab og chlorambucil, 227 patienter fik chlorambucil alene) blev der set forlænget neutropeni (defineret som neutropeni af grad 3 eller 4, som ikke blev korrigeret indenfor 24 og 42 dage efter sidste dosis af studiebehandlingen) hos 41 patienter (9 %) (23 patienter [11 %], der blev behandlet med ofatumumab og chlorambucil, 18 patienter [8 %], der blev behandlet med chlorambucil alene).
English: Arzerra 100 mg is available in a pack containing 3 vials.
Danish: Arzerra 100 mg fås i pakninger, der indeholder 3 hætteglas.
English: The median age was 69 years (range: 35 to 92 years), 27% patients were ≥75 years of age, 63% were male and 89% were white.
Danish: Gennemsnitsalderen var 69 år (interval: 35 til 92 år), 27 % af patienterne var ≥75 år, 63 % var mænd, og 89 % var hvide.
English: The remaining infusions will then be given once a month for four months.
Danish: De resterende infusioner gives efterfølgende én gang om måneden i fire måneder.
English: Reactivation has also occurred in patients who appear to have resolved hepatitis B infection (i.e. HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [antiHBs] positive).
Danish: Reaktivering er også set hos patienter, hvis hepatitis B-infektion tilsyneladende var faldet til ro (f.eks. HBsAg-negativ, anti-HBc-positiv og hepatitis B-overfladeantistof- [anti-HBs-] positiv).
English: Cycle 1 51.8 2620
Danish: Cyklus 1 51,8 2.620
English: Arzerra contains 34.8 mg sodium in each 300 mg dose, 116 mg sodium in each 1000 mg dose and 232 mg sodium in each 2000 mg dose.
Danish: Arzerra indeholder 34,8 mg natrium pr. 300 mg dosis, 116 mg natrium pr. 1000 mg dosis og 232 mg natrium pr. 2000 mg dosis.
English: ----OFA + FC (N=183) Median 28.94 months 95% CI (22.80, 35.88) ____FC (N=182) Median 18.83 months 95% CI (14.42,25.82)
Danish: ----OFA + FC (N=183) Median 28,94 måneder 95% CI (22,80, 35,88)
English: Arzerra must not be administered as an intravenous push or bolus.
Danish: Arzerra må ikke administreres som en intravenøs bolusinjektion.
English: (E433), edetate disodium (E386), hydrochloric acid (E507) (for pH-adjustment), water for injections (see “Arzerra contains sodium” under section 2).
Danish: dinatriumedetat (E386), saltsyre (E507) (til pH-justering), vand til injektionsvæsker (se “Arzerra indeholder natrium” under punkt 2)
English: Patient median age was 64 years (range: 41 to 87 years), and the majority were male (73%) and white (96%).
Danish: Patienternes medianalder var 64 år (interval: 41 til 87 år), og størstedelen var mænd (73 %) og hvide (96 %).
English: Treatment with Arzerra (when given as 4 once-weekly infusions), led to a 50% objective response rate in the highest dose group (1st dose: 500 mg; 2nd, 3rd and 4th dose: 2,000 mg) and included 12 partial remissions and one nodular partial remission.
Danish: Behandling med Arzerra (administreret i form af en infusion om ugen i 4 uger) resulterede i en objektiv responsrate på 50 % i den gruppe, der fik den højeste dosis (1. dosis: 500 mg, 2., 3. og 4. dosis: 2000 mg).
English: Any unused infusion solution should be discarded 24 hours after preparation.
Danish: Eventuel ubrugt infusionsvæske skal kasseres 24 timer efter fortyndingen.
English: Arzerra 1000 mg is available in a pack containing 1 vial.
Danish: Arzerra 1000 mg fås i pakninger, der indeholder 1 hætteglas.
English: The infusion must be completed within 24 hours after preparation.
Danish: Infusionen skal være gennemført inden for 24 timer efter klargøringen.
English: Patients received ofatumumab as intravenous infusions (cycle 1: 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days).
Danish: Patienterne fik ofatumumab som intravenøse infusioner (cyklus 1: 300 mg på dag 1 og 1000 mg på dag 8; efterfølgende cyklusser: 1000 mg på dag 1 hver 28. dag).
English: Even with premedication, severe reactions, including cytokine release syndrome, have been reported following use of ofatumumab.
Danish: Selv i forbindelse med præmedicinering er der indberettet alvorlige reaktioner ved brug af ofatumumab, herunder cytokinfrigivelsessyndrom.