FrancophonIA/ELRC3.0 huggingface dataset:
English: Of these 223 patients, 95 patients were refractory to fludarabine and alemtuzumab therapy (defined as failure to achieve at least a partial response with fludarabine or alemtuzumab treatment or disease progression within 6 months of the last dose of fludarabine or alemtuzumab).
Danish: Af disse 223 patienter var 95 refraktære over for behandling med fludarabin og alemtuzumab (defineret som en behandling, hvor det ikke var muligt at opnå mindst et partielt respons med fludarabin eller alemtuzumab, eller hvor der sås sygdomsprogression indenfor 6 måneder efter den sidste dosis fludarabin eller alemtuzumab).
English: Relapsed CLL (ofatumumab + FC)
Danish: Recidiverende CLL (ofatumumab + FC)
English: Refractory CLL (ofatumumab)
Danish: Refraktær CLL (ofatumumab)
English: Abbreviations: CI = confidence interval, CLL = chronic lymphocytic leukaemia, CR = complete response, IRC = Independent Review Committee, MRD = minimal residue disease, N = number, ORR = overall response rate
Danish: Forkortelser: CLL= kronisk, lymfatisk leukæmi, CR= komplet respons, IRC= Independent Review Committee, MRD= Minimal Residue Disease, N= antal, ORR= overordnet responsrate.
English: No clinically relevant pharmacokinetic interactions were observed between ofatumumab and fludarabine, cyclophosphamide,bendamustine, chlorambucil, or its active metabolite, phenylacetic acid mustard.
Danish: Der blev ikke observeret nogen klinisk relevante farmakokinetiske interaktioner mellem ofatumumab og fludarabin, cyclophosphamid, bendamustin, chlorambucil eller dets aktive metabolit, phenyleddikesyre-kvælstofsennepsgas.
English: Intravenous and subcutaneous administration to monkeys resulted in the expected depletion of peripheral and lymphoid tissue B-cell counts with no associated toxicological findings.
Danish: Intravenøs og subkutan administration til aber resulterede i den forventede depletion af B-celler i perifert og lymfoidt væv uden relaterede toksikologiske fund.
English: Progressive multifocal leukoencephalopathy (PML) Progressive multifocal leukoencephalopathy (PML), a serious and life-threatening brain condition, has been reported with medicines like Arzerra.
Danish: Progressiv multifokal leukoencefalopati (PML), der er en alvorlig og livstruende tilstand i hjernen, er rapporteret ved brug af medicin som Arzerra.
English: There was no statistically significant difference in the primary endpoint of IRC assessed PFS (5.4 vs. 3.6 months, HR=0.79, p=0.27).
Danish: Der var ingen statistisk signifikant forskel i det primære endepunkt af IRC-vurderet PFS (5,4 vs. 3,6 måneder, HR=0,79; p=0,27).
English: • throat pain or irritation
Danish: • ondt i halsen eller irritation i halsen
English: Ofatumumab is a human monoclonal antibody produced in a recombinant murine cell line (NS0).
Danish: Ofatumumab er et humant, monoklonalt antistof, som produceres i en rekombinant murin cellelinje (NS0).
English: The ORR was higher for OFA+FC versus FC (84% versus 68%, p=0.0003).
Danish: ORR var højere for OFA+FC versus FC (84 % versus 68 %; p=0,0003).
English: Increases above 5 msec were observed in the median/mean QT/QTc intervals in the pooled analysis.
Danish: Der blev set stigninger over 5 ms i median/gennemsnits- QT/QTc-intervallerne i den samlede analyse.
English: The median progression-free survival was 5.5 months (95% CI: 4.6, 6.4) and the median overall survival was 17.4 months (95% CI: 15.0, 24.0).
Danish: Medianen af den progressionsfrie overlevelse var 5,5 måneder (95 % konfidensinterval: 4,6, 6,4), og medianen af den samlede overlevelse var 17,4 måneder (95 % konfidensinterval: 15,0, 24,0).
English: The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complementdependent cytotoxicity and resultant lysis of tumour cells.
Danish: Binding af ofatumumab til den membran-proksimale del af epitopet på CD20-molekylet, inducerer rekruttering og aktivering af komplementsystemet på celleoverfladen, hvilket fører til komplementafhængig cytotoksicitet og dermed lysering af tumorcellerne.
English: No teratogenicity or maternal toxicity were observed in an animal reproduction study with administration of ofatumumab to pregnant monkeys (see section 5.3).
Danish: Ingen teratogenicitet eller maternel toksicitet blev observeret i et reproduktionsstudie i dyr, hvor gravide aber fik administreret ofatumumab (se pkt.
English: Figure 2 Kaplan-Meier estimates of PFS in relapsed CLL
Danish: Figur 2 Kaplan-Meier-estimater for PFS ved recidiverende CLL
English: Abbreviations: β2M = beta-2-microglobulin, CI = confidence interval; CIRS-G = Cumulative Illness Rating Scale for Geriatrics, CLL = chronic lymphocytic leukaemia, CrCl = creatinine clearance, ECOG = Eastern Cooperative Oncology Group, IGHV = Immunoglobulin Heavy Chain Variable Region, IRC = Independent Review Committee, N = number, NR = not reached, PFS = progression-free survival, ZAP-70 = zeta-chain-associated protein kinase 70.
Danish: Forkortelser: β2M= beta-2-microglobulin, CIRS-G= Cumulative Illness Rating Scale for Geriatrics, CLL= kronisk, lymfatisk leukæmi, CrCl= kreatininclearance, ECOG= Eastern Cooperative Oncology Group, IGHV= Immunoglobulin Heavy Chain Variable Region, IRC= Independent Review Committee, N= antal, IN= ikke nået, PFS= progressionsfri overlevelse, ZAP-70= zeta-kæde-associeret proteinkinase 70.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Arzerra in all subsets of the paediatric population in chronic lymphocytic leukaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Arzerra i alle undergrupper af den pædiatriske population med kronisk, lymfatisk leukæmi (se pkt.
English: Laboratory monitoring
Danish: Laboratorieanalyser
English: At the end of organogenesis (day 48 of gestation), the ofatumumab exposure (AUCinf) corresponded to 0.46 to 3.6 times the human exposure after the eighth infusion of the maximum recommended human dose (MRHD) of 2000 mg. At day 100 of gestation, depletion of B-cells relating to the pharmacological activity of ofatumumab were observed in foetal cord blood and foetal splenic tissues.
Danish: Ved afslutningen af organogenesen (dag 48 af svangerskabet) svarede ofatumumab-eksponeringen (AUCinf) til 0,46 til 3,6 gange den menneskelige eksponering efter den ottende infusion af den maksimale anbefalede humane dosis (MRHD) på 2000 mg. På dag 100 i drægtighedsperioden blev der observeret depletion af B-celler i fosterets navlestrengsblod og miltvæv på grund af ofatumumabs farmakologiske aktivitet.
English: *Up to 13 infusions in previously untreated CLL; up to 7 infusions in relapsed CLL **Corticosteroid may be either reduced or omitted for subsequent infusions at the discretion of the physician, if a severe infusion-related adverse drug reaction (ADR) did not occur with the preceding infusion(s).
Danish: *Op til 13 infusioner for tidligere ubehandlet CLL; op til 7 infusioner for recidiverende CLL **Lægen kan vurdere enten at reducere eller udelade kortikosteroid for den efterfølgende infusion, hvis der ikke forekom en alvorlig infusionsrelateret bivirkning ved den/de tidligere infusion(er).
English: The primary endpoint was ORR assessed by the investigator according to the 2008 IWCLL guidelines.
Danish: Det primære endepunkt var ORR vurderet af investigator efter 2008 IWCLL guidelines.
English: There are limited pharmacokinetic data in patients with severe renal impairment (creatinine clearance <30 ml/min).
Danish: Der er begrænsede farmakokinetiske data fra patienter med svært nedsat nyrefunktion (kreatininclearance på <30 ml/minut).
English: Hepatitis B infection and reactivation, progressive multifocal leukoencephalopathy
Danish: Hepatitis Binfektion ogreaktivering, progressiv multifokal leukoencefalopati
English: You should be tested for hepatitis B (a liver disease) before starting Arzerra treatment.
Danish: Du bør testes for hepatitis B-infektion (en leversygdom), før du begynder på behandling med Arzerra.
English: Patients with benefit/patients with abnormality at baseline (%) Patients refractory to fludarabine and alemtuzumab
Danish: Patienter, der opnår en gavnlig effekt/patienter med abnormitet ved udgangsniveauet (%) Fludarabin- og alemtuzumab-refraktære patienter
English: Limited data are available in the heterogeneous non-white population and in patients with an ECOG performance status of 2.
Danish: Der er begrænsede data tilgængelig fra den heterogene ikke-hvide population samt fra patienter med ECOG-performancestatus 2.
English: 0 to 100 mg**
Danish: 0 til 100 mg**
English: • If you have persistent stomach pain, see your doctor as soon as possible.
Danish: Hvis du har vedvarende mavesmerter, skal du hurtigst muligt gå til lægen.
English: No data comparing Arzerra in combination with bendamustine or with chlorambucil versus a rituximab based regimen such as rituximab with chlorambucil is available.
Danish: Der er ingen tilgængelige data, der sammenligner Arzerra i kombination med bendamustin eller med chlorambucil versus en rituximabbaseret behandling, som f.eks. rituximab sammen med chlorambucil.
English: Arzerra is used to treat chronic lymphocytic leukaemia (CLL).
Danish: Arzerra anvendes til behandling af kronisk lymfatisk leukæmi (CLL).
English: • Subsequent cycles (until best response or a maximum of 12 cycles): 1000 mg on day 1 every
Danish: • Efterfølgende cyklusser (indtil bedste respons er opnået eller maksimalt 12 cyklusser): 1000 mg på dag 1 (hver 28. dag).
English: Table 5 Ofatumumab pharmacokinetic parameters (geometric mean)
Danish: Tabel 5 Ofatumumabs farmakokinetiske værdier (geometrisk gennemsnit)
English: Arzerra contains ofatumumab, which belongs to a group of medicines called monoclonal antibodies.
Danish: Arzerra indeholder ofatumumab, der tilhører en gruppe af lægemidler, som kaldes monoklonale antistoffer.
English: Glaxo Operations UK Ltd. Harmire Road Barnard Castle Durham, DL12 8DT United Kingdom
Danish: Glaxo Operations UK Ltd. Harmire Road Barnard Castle Durham, DL12 8DT Storbritannien
English: Your doctor will weigh up the benefit to you against the risk to your baby of taking Arzerra while you're pregnant.
Danish: Lægen vil vurdere fordelene for dig ved behandling med Arzerra under graviditeten i forhold til risikoen for dit ufødte barn.
English: Premedication schedule for Arzerra
Danish: Præmedicineringsskema for Arzerra
English: Progressive multifocal leukoencephalopathy
Danish: Progressiv, multifokal leukoencefalopati
English: Possible side effects
Danish: Mulige bivirkninger
English: Hepatitis B virus (HBV) infection and reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has occurred in patients treated with medicinal products classified as CD20directed cytolytic antibodies, including Arzerra.
Danish: Der er set hepatitis B virus (HBV)-infektion og reaktivering af hepatitis B virus, som i nogle tilfælde kan udvikles til fulminant hepatitis, leversvigt og død, hos patienter behandlet med lægemidler, der er klassificeret som cytolytiske antistoffer rettet mod CD20-antigenet, herunder Arzerra.
English: Breast-feeding should be discontinued during treatment with Arzerra and for 12 months following treatment.
Danish: Amning skal ophøre under behandling med Arzerra og i 12 måneder efter behandlingen.
English: Baseline calculated creatinine clearance was not found to be a significant factor on ofatumumab pharmacokinetics in a cross-study population analysis in patients with calculated creatinine clearance values ranging from 26 to 287 ml/min.
Danish: Den beregnede kreatininclearance ved udgangsniveauet viste sig ikke at være en signifikant faktor for farmakokinetikken af ofatumumab i en cross-study-populationsanalyse hos patienter med kreatininclearance-værdier i intervallet fra 26 til 287 ml/minut.
English: Time after start of infusion
Danish: Tid efter infusionsstart
English: • frequent infections, fever, chills, sore throat or mouth ulcers due to infections
Danish: • hyppige infektioner, feber, kulderystelser, ondt i halsen eller mundsår på grund af infektioner
English: Subsequent infusions
Danish: Efterfølgende infusioner
English: These may include anti-histamines, steroids and pain relievers.
Danish: Det kan være antihistaminer, steroider og smertestillende medicin.
English: Overall response rate Responders, n (%) 95.3% CI (%) Response rate in patients with prior rituximab therapy Responders, n (%) 95% CI (%) Response rate in patients with chromosomal abnormality 17p deletion Responders, n (%) 95% CI (%) 11q deletion Responders, n (%) 95% CI (%) Median overall survival Months 95% CI Progression-free survival Months 95% CI Median duration of response Months 95% CI Median time to next CLL therapy Months 95% CI The overall response was assessed by an Independent Response Committee using the 1996 NCI-WG guidelines for CLL.
Danish: Samlet responsrate Respondenter, n (%) 95,3 % konfidensinterval (%) Responsrate hos patienter, der har fået forudgående behandling med rituximab Respondenter, n (%) 95 % konfidensinterval (%) Responsrate hos patienter med kromosomabnormitet 17p-deletion Respondenter, n (%) 95 % konfidensinterval (%) 11q-deletion Respondenter, n (%) 95 % konfidensinterval (%) Median af samlet overlevelse Måneder 95 % konfidensinterval Progressionsfri overlevelse Måneder 95 % konfidensinterval Medianvarighed af respons Måneder 95 % konfidensinterval Mediantid til næste CLL-behandling Måneder 95 % konfidensinterval Det samlede respons blev bestemt af en uafhængig responskomite, som benyttede retningslinjerne vedrørende CLL fra NCI-WG fra 1996.
English: • yellow skin and eyes, nausea, loss of appetite, dark urine (possible symptoms of an infection or reactivation of hepatitis B virus)
Danish: • gulfarvning af hud og øjne, kvalme, appetitløshed, mørk urin (mulige symptomer på infektion eller reaktivering af hepatitis B-virus)
English: Clear to opalescent, colourless to pale yellow liquid.
Danish: Klar til opaliserende, farveløs til svagt gul væske.
English: The overall response rate in this group was 63% (95.3% CI: 35, 85).
Danish: Den samlede responsrate i denne gruppe var 63 % (95,3 % konfidensinterval: 35, 85).
English: This includes 643 patients treated with ofatumumab as monotherapy (in patients with relapsed or refractory CLL) and 525 patients treated with ofatumumab in combination with chemotherapy (chlorambucil or bendamustine or fludarabine and cyclophosphamide).
Danish: Den inkluderer 643 patienter, som blev behandlet med ofatumumab som monoterapi (patienter med remitterende eller refraktær CLL), og 525 patienter, der blev behandlet med ofatumumab i kombination med kemoterapi (chlorambucil eller bendamustin eller fludarabin og cyclophosphamid).
English: • Subsequent cycles (up to a maximum of 6 cycles in total): 1000 mg on day 1 every 28 days.
Danish: • Efterfølgende cyklusser (i op til maksimalt 6 cyklusser i alt): 1000 mg på dag 1 hver 28 dag.
English: Formation of anti-ofatumumab antibodies was observed for less than 0.5% of patients with CLL after treatment with ofatumumab.
Danish: Der blev observeret mindre end 0,5 % dannelse af anti-ofatumumab-antistoffer hos <1 % af patienterne med CLL efter behandling med ofatumumab.
English: A diagnosis of PML should be considered in any Arzerra patient who reports the new onset of or changes in pre-existing neurological signs and symptoms.
Danish: Diagnosen PML skal overvejes hos patienter, der får Arzerra, hvor der opstår eller sker ændringer i eksisterende neurologiske fund og symptomer.
English: It is not known whether the ingredients in Arzerra pass into human milk.
Danish: Det vides ikke, om indholdsstofferne i Arzerra går over i modermælken.
English: Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of complement defence molecules.
Danish: Det har vist sig, at ofatumumab inducerer betydelig lysering af celler med høje ekspressionsniveauer af komplementmolekyler.
English: • fever or, alternatively, a very low body temperature, chest pain, shortness of breath or rapid breathing, shaking, chills, confusion, dizziness, decreased urination and rapid pulse, (possible symptoms of blood infection)
Danish: • feber eller alternativt en meget lav kropstemperatur, brystsmerter, åndenød eller hurtig vejrtrækning, rystelser, kulderystelser, forvirring, svimmelhed, nedsat vandladning og hurtig puls (mulige symptomer på blodinfektion)
English: How Arzerra is given
Danish: Sådan gives Arzerra
English: Previously untreated CLL
Danish: Tidligere ubehandlet CLL
English: Anaphylactic reactions (including anaphylactic shock)*
Danish: Overfølsomhed* Anafylaktiske reaktioner (inklusive anafylaktisk shock)*
English: 1) Before diluting Arzerra
Danish: 1) Inden fortynding af Arzerra
English: Do not shake the ofatumumab vial for this inspection.
Danish: Hætteglasset med ofatumumab må ikke rystes i forbindelse med denne inspektion.
English: Administration of live vaccines to neonates and infants exposed to ofatumumab in utero should be avoided until B-cell recovery occurs (see sections 4.4 and 4.5).
Danish: Neonater og spædbørn, som har været eksponeret for ofatumumab in utero, skal undgå behandling med levende vacciner indtil B-celleniveauet er normaliseret (se pkt 4.4 og 4.5).
English: In patients who develop reactivation of HBV while receiving Arzerra, Arzerra and any concomitant chemotherapy should be interrupted immediately, and appropriate treatment instituted.
Danish: Hos patienter, hvor HBV reaktiveres, mens de får Arzerra, skal Arzerra og enhver anden samtidig kemoterapi straks seponeres og passende behandling iværksættes.
English: • Use a reliable method of contraception to avoid becoming pregnant while you are being treated with Arzerra, and for 12 months after your last dose of Arzerra.
Danish: • Du skal bruge sikker prævention for at undgå at blive gravid, så længe du får Arzerra og i mindst 12 måneder efter den sidste dosis af Arzerra.
English: Driving and using machines Arzerra is unlikely to affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Arzerra påvirker sandsynligvis ikke din evne til at føre motorkøretøj eller betjene maskiner.
English: First infusion
Danish: Første infusion
English: No studies on the effects of Arzerra on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: If you have been previously treated for CLL you will usually have a course of 12 infusions.
Danish: Hvis du tidligere er blevet behandlet for CLL, gives der normalt 12 infusioner i behandlingsforløbet.
English: Cmax = maximum ofatumumab concentration at the end of infusion, AUC = exposure to ofatumumab over a dosing period, CL = ofatumumab clearance after multiple doses, T½ = terminal half-life Numbers rounded to three significant digits
Danish: Cmax: maksimal ofatumumabkoncentration ved afslutningen af infusionen, AUC: eksponering for ofatumumab i en doseringsperiode, CL: clearance af ofatumumab efter flere doser, T½: terminal halveringstid
English: • problems with blood clotting
Danish: • problemer med blodets størkningsevne
English: Uncommon side effects that may show up in your blood tests:
Danish: Ikke almindelige bivirkninger, der kan ses i dine blodprøver:
English: Lower respiratory tract infection (including pneumonia), upper
Danish: Infektion i de nedre luftveje (herunder pneumoni), infektion i de øvre luftveje
English: The overall response rate (ORR) including complete response (CR) was also assessed by an IRC using the 2008 IWCLL guidelines.
Danish: Den overordnede responsrate (ORR), inklusive komplet respons (CR), blev også vurderet af en IRC ved brug af 2008 IWCLL-guidelines.
English: If the coadministration is judged unavoidable, the risks and benefits of vaccinating patients during therapy with ofatumumab should be considered (see section 4.4).
Danish: Hvis samtidig administration ikke kan undgås, skal risiciene og fordelene ved vaccination af patienter under behandlingen med ofatumumab overvejes (se pkt.
English: Cases of progressive multifocal leukoencephalopathy (PML) resulting in death have been reported in CLL patients receiving cytotoxic pharmacotherapy, including ofatumumab.
Danish: Der har været indberettet tilfælde af progressiv multifokal leukoencefalopati (PML), der har resulteret i dødsfald hos CLL-patienter, som fik cytotoksisk farmakoterapi, herunder ofatumumab.
English: For previously untreated CLL, the recommended dosage and schedule is:
Danish: Ved tidligere ubehandlet CLL er den anbefalede dosis og doseringsskema:
English: This medicinal product contains 34.8 mg sodium per 300 mg dose, 116 mg sodium per 1000 mg dose and 232 mg sodium per 2000 mg dose.
Danish: Dette lægemiddel 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: The initial rate of the first and second infusion of Arzerra should be 12 ml/hour.
Danish: Den indledende infusionshastighed ved den første og anden infusion af Arzerra bør være 12 ml/time.
English: • fluid in the lungs (pulmonary oedema) causing breathlessness
Danish: • væske i lungerne (lungeødem), som giver vejrtrækningsbesvær
English: Contact your doctor immediately if you experience constipation, a swollen abdomen or abdominal pain.
Danish: Kontakt straks lægen, hvis du oplever forstoppelse, oppustet mave eller mavesmerter.
English: As ofatumumab is a monoclonal antibody, genotoxicity and carcinogenicity studies have not been conducted with ofatumumab.
Danish: Da ofatumumab er et monoklonalt antistof, er der ikke udført forsøg til vurdering af ofatumumabs genotoksicitet og karcinogenicitet.
English: Do not use this medicine after the expiry date shown on the carton and vial label.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og på etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: No formal studies were conducted to examine the effect of hepatic impairment.
Danish: Der er ikke udført formelle studier for at undersøge effekten af nedsat leverfunktion.
English: 3) How to administer the diluted solution
Danish: 3) Administration af den fortyndede opløsning
English: cells available for the antibody to bind at subsequent infusions.
Danish: +-celler tilbage, som antistoffet kunne binde sig til ved de efterfølgende infusioner.
English: The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed increasing the rate every 30 minutes).
Danish: Infusionshastigheden kan fortsat øges i henhold til standardprocedurer, lægens skøn og patientens tolerance (dog må hastigheden ikke øges oftere end hvert 30. minut).
English: Cycle 1 61.4
Danish: Cyklus 1 61.4
English: Infusion-related reactions may include, but are not limited to, anaphylactoid events, bronchospasm, cardiac events (e.g. myocardial ischaemia/infarction, bradycardia), chills/rigors, cough, cytokine release syndrome, diarrhoea, dyspnoea, fatigue, flushing, hypertension, hypotension, nausea, pain, pulmonary oedema, pruritus, pyrexia, rash, and urticaria.
Danish: Infusionsrelaterede reaktioner kan omfatte, men er ikke begrænset til, anafylaktoide reaktioner, bronkospasme, kardielle hændelser (f.eks. iskæmisk hjertesygdom/myokardieinfarkt, bradykardi), kuldegysninger/kulderystelser, hoste, cytokinfrigivelsessyndrom, diarré, dyspnø, træthed, rødmen, hypertension, hypotension, kvalme, smerter, lungeødem, pruritus, feber, udslæt og urticaria.
English: Patients with a history of cardiac disease should be monitored closely.
Danish: Patienter, som tidligere har haft en hjertesygdom skal overvåges nøje.
English: For the highest dose group, the median time to progression was 15.6 weeks (95% CI: 15,22.6) in the full analysis population, and 23 weeks (CI: 20,31) in responders.
Danish: I den gruppe, der fik den højeste dosis, var mediantiden til progression 15,6 uger (95 % konfidensinterval: 15, 22,6) i den fulde analysepopulation og 23 uger (konfidensinterval: 20, 31 uger) hos respondenterne.