FrancophonIA/ELRC3.0 huggingface dataset:
English: Across all development studies the treatment benefit was similar in patients independent of age, gender, body surface area, race, number of prior treatments or disease status.
Danish: På tværs af alle udviklingsstudier var udbyttet af behandlingen sammenlignelig hos patienterne uafhængigt af alder, køn, legemsoverfladeareal, race, antal tidligere behandlinger eller sygdomsstatus.
English: Adverse reactions are listed in Table 2.
Danish: Bivirkningerne er angivet i tabel 2.
English: 40% of patients with bone marrow involvement responded compared to 59% of patients with no bone marrow involvement (p=0.0186).
Danish: 40 % af patienterne med involvering af knoglemarven responderede sammenlignet med 59 % af patienterne uden involvering af knoglemarven (p = 0,0186).
English: Primary analysis (median FU: 25 months)
Danish: Primær analyse (median opfølgning: 25 måneder)
English: The proportion of patients with IgG levels below the LLN was about 60% in the rituximab group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Danish: Andelen af patienter med IgG-niveauer under den nedre referenceramme var ca. 60 % i rituximab gruppen i hele behandlingsperioden på 2 år, hvorimod den faldt i observationsgruppen (36 % efter 2 år).
English: Rituximab was detectable in the serum of patients 3 - 6 months after completion of last treatment.
Danish: Rituximab kunne detekteres i patienternes serum i op til 3-6 måneder efter færdiggørelse af den sidste behandling.
English: Occurred at various times up to several months after completion of rituximab therapy
Danish: Forekom på forskellige tidspunkter op til flere måneder efter afslutningen af behandlingen med rituximab
English: Severe infusion-related reactions (such as bronchospasm, hypotension) occurred in up to 12% of the cases.
Danish: Der forekom svære infusionsrelaterede reaktioner (som f.eks. bronkospasmer eller hypotension) i op til 12 % af tilfældene.
English: Three of the patients had received two courses of rituximab before enrolment and thus were given a third course in the study.
Danish: Tre patienter havde fået 2 serier med rituximab før inklusion og fik således den tredje serie i studiet.
English: Sustained improvement in physical function as indicated by the HAQ-DI score and the proportion of patients achieving MCID for HAQ-DI were observed.
Danish: Der blev observeret vedvarende forbedring af fysisk funktion angivet ved HAQ-DI-score og andelen af patienter, som opnåede MCID for HAQ-DI.
English: If the same severe adverse reactions occur for a second time, the decision to stop the treatment should be seriously considered on a case by case basis.
Danish: Hvis de samme alvorlige bivirkninger forekommer igen, bør man i hvert enkelt tilfælde alvorligt overveje at tage beslutning om at stoppe behandlingen.
English: • pain in the muscles or in the hands or feet
Danish: • smerter i muskler eller hænder og fødder
English: Median TTF/PFS/ EFS mo
Danish: Median TTF/PFS/ EFS måneder
English: It is not known whether Ritemvia has an effect on you being able to drive or use any tools or machines.
Danish: Det vides ikke, om Ritemvia påvirker din evne til at køre motorkøretøj eller arbejde med maskiner.
English: • if you have ever taken medicines which affect your immune system - such as chemotherapy or immune-suppressive medicines.
Danish: • om du nogensinde har fået medicin, der påvirker immunforsvaret, f.eks. kemoterapi eller medicin, der nedsætter immunforsvaret.
English: PML, reactivation of hepatitis B
Danish: PML, reaktivering af hepatitis B
English: On the basis of standardised incidence ratios, the incidence of malignancies appears to be similar to that previously reported in patients with ANCA-associated vasculitis.
Danish: På baggrund af standardiserede incidensratioer synes malignitetshyppigheden at svare til den, der tidligere er indberettet hos patienter med ANCA-associeret vaskulitis.
English: Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Danish: Rituximab inducerede B-cellereduktion hos 70 % til 80 % af patienterne, men blev kun ledsaget af nedsat serum-immunglobulin hos en mindre del af patienterne.
English: For mixing the solution, gently invert the bag in order to avoid foaming.
Danish: Bland opløsningen ved at vende posen forsigtigt for at undgå skumdannelse.
English: No studies on the effects of rituximab on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that rituximab would have no or negligible influence on the ability to drive and use machines.
Danish: Der er ikke foretaget studier af rituximabs indflydelse på evnen til at føre bil og betjene maskiner, men den farmakologiske virkning og de indtil dato rapporterede bivirkninger tyder på, at rituximab ikke, eller kun i ubetydelig grad, påvirker evnen til at føre motorkøretøj og betjene maskiner.
English: This analysis suggests that dose adjustment of rituximab with any of the tested covariates is not expected to result in a meaningful reduction in its pharmacokinetic variability.
Danish: Denne analyse antyder, at doseringsjusteringer for rituximab baseret på de testede variable ikke forventes at give en relevant reduktion i den farmakokinetiske variation.
English: Patients with higher CD19-positive cell counts or tumour lesions had a higher CL2.
Danish: Patienter med højere CD-19 positive celletal og eller tumorbyrde havde en højere CL2.
English: Included patients were 21 to 75 years of age and had newly diagnosed or relapsing disease in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide.
Danish: Inkluderede patienter var 21 til 75 år og havde nyligt diagnosticeret eller recidiverende sygdom i fuldstændig remission efter kombineret behandling med glukokortikoider og pulsbehandling med cyclophosphamid.
English: Ritemvia contains sodium
Danish: Ritemvia indeholder natrium
English: • raised blood pressure
Danish: • forhøjet blodtryk
English: Treatment difference (Rituximabcyclophosphamide)
Danish: Behandlingsforskel (rituximabcyclophosphamid)
English: • recurrence of a previous Hepatitis B infection c) If you are being treated for pemphigus vulgaris
Danish: • genopblussen af tidligere hepatitis B-infektion c) Hvis du behandles for pemfigus vulgaris
English: • changes in the rhythm of the heart, or the heart beating faster than normal
Danish: • ændringer i hjerterytmen, eller hjertet slår hurtigere end normalt
English: These are often colds, but there have been cases of pneumonia or urinary infections.
Danish: Det vil ofte dreje sig om forkølelser, men der har været tilfælde af lungebetændelse og urinvejsinfektioner.
English: The cells that are affected by Ritemvia help to fight infection and you should wait until the infection has passed before you are given Ritemvia.
Danish: Cellerne, der påvirkes af Ritemvia hjælper med at bekæmpe infektioner, og du bør vente med behandling med Ritemvia, indtil infektionen er forsvundet.
English: These studies support the use of rituximab with any chemotherapy.
Danish: Disse studier understøtter anvendelse af rituximab sammen med enhver kemoterapi.
English: All IRRs were CTC Grade 1 or 2.
Danish: Alle infusionsrelaterede reaktioner var af CTC-grad 1 eller 2.
English: A maintenance infusion of 500 mg IV should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation.
Danish: En vedligeholdelsesinfusion på 500 mg intravenøst skal administreres ved måned 12 og 18, og derefter hver 6. måned efter behov, baseret på den kliniske vurdering.
English: Oncology indications:
Danish: Onkologi-indikationer:
English: Tell your doctor immediately if you have any of these symptoms.
Danish: Fortæl det øjeblikkeligt til lægen, hvis du oplever nogen af disse symptomer.
English: Respiratory system Cases of interstitial lung disease, some with fatal outcome, have been reported.
Danish: Det respiratoriske system Tilfælde af interstitiel lungesygdom, hvoraf nogle med dødelig udgang, er blevet rapporteret.
English: Population pharmacokinetic analysis of the same data gave similar mean values for systemic clearance and half-life, 0.26 L/day and 20.4 days, respectively.
Danish: Farmakokinetisk analyse af populationen af de samme data gav sammenlignelige gennemsnitlige værdier for systemisk clearance og halveringstid; henholdsvis 0,26 l/dag og 20,4 dage.
English: Rituximab maintenance treatment reduced the risk of death by 56% (95% CI; 22%-75%).
Danish: Rituximab vedligeholdelsesbehandling reducerede risikoen for død med 56 % (95 % konfidensinterval: 22 % - 75 %).
English: Whether rituximab is excreted in human milk is not known.
Danish: Det vides ikke om rituximab udskilles i humanmælk.
English: Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Danish: Patienter med positiv hepatitis B-serologi (enten HBsAg eller HBcAb) bør inden påbegyndelse af behandling konsultere en specialist i leversygdomme og bør overvåges og behandles i henhold til lokale kliniske standarder for at forebygge hepatitis B-reaktivering.
English: Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately.
Danish: Hos patienter, som udvikler tegn på alvorlige reaktioner, især alvorlig dyspnø, bronkospasme eller hypoxi, skal infusionen straks afbrydes.
English: Pneumocystis jirovecii pneumonia prophylaxis was required for all patients with CD4+ T-lymphocyte counts less than 250 per cubic millimeter.
Danish: Pneumocystis jirovecii pneumoni profylakse var påkrævet for alle patienter med CD4+ T-lymfocyttal lavere end 250 pr. kubikmillimeter.
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials 2 Frequency category derived from post-marketing data.
Danish: 1 Hyppigheden stammer fra laboratorie-værdier, som var indsamlet som en del af rutinemæssig laboratorie-overvågning i kliniske studier 2 Hyppigheden stammer fra data efter markedsføring
English: Patients in a severely immunocompromised state.
Danish: Svært immunkompromitterede patienter.
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue rituximab.
Danish: Afhængig af sværhedsgraden af de infusionsrelaterede reaktioner og de nødvendige indgreb, skal rituximab-behandlingen midlertidigt eller permanent afbrydes.
English: 3 Reactions occurring during or within 24 hours of infusion.
Danish: 3 Reaktioner, som forekommer inden for 24 timer efter infusion.
English: Patients reporting signs and symptoms of infection following rituximab therapy should be promptly evaluated and treated appropriately.
Danish: Patienter, der rapporterer signaler og symptomer på infektion efter behandling med rituximab bør straks undersøges og behandles som nødvendigt.
English: Active, severe infections (see section 4.4).
Danish: Aktive, alvorlige infektioner (se pkt.
English: Multiple courses of treatment are associated with a similar ADR profile to that observed following first exposure.
Danish: Gentagne behandlingsserier er forbundet med en bivirkningsprofil, som ligner den, som observeres efter første eksponering.
English: Keep this card with you for 2 years after your last dose of Ritemvia.
Danish: Opbevar dette kort på dig i 2 år efter, at du har fået den sidste Ritemvia-dosis.
English: The emergence of ADA was not associated with clinical deterioration or with an increased risk of reactions to subsequent infusions in the majority of patients.
Danish: Udviklingen af ADA var ikke forbundet med klinisk forværring eller øget risiko for reaktioner ved efterfølgende infusioner hos hovedparten af disse patienter.
English: Injury, poisoning and procedural complications
Danish: Skader, forgiftninger og proceduremæssige komplikationer
English: Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML.
Danish: Patienterne skal undersøges med regelmæssige intervaller for nye eller forværring af eksisterende neurologiske symptomer eller tegn, der kunne tyde på PML.
English: None of the 99 rituximab-treated patients were ADA positive at screening.
Danish: Ingen af de 99 rituximab-behandlede patienter var ADA-positive ved screening.
English: NR: not reached; a: only applicable to patients achieving a CR
Danish: NR: ikke opnået; a: kun gældende for patienter, der opnåede fuldstændigt respons
English: Efficacy outcomes in rituximab treated patients were analysed based on autoantibody status prior to commencing treatment.
Danish: Resultater for effekt hos patienter behandlet med rituximab, blev analyseret på basis af autoantistofstatus forud for påbegyndt behandling.
English: A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of rituximab.
Danish: En lille andel af patienterne havde forlænget perifer B-celle-depletion, der varede 2 år eller mere efter sidst rituximab-dosis.
English: No long-term animal studies have been performed to establish the carcinogenic potential of rituximab.
Danish: Der er ikke gennemført langtidsstudier på dyr med henblik på vurdering af rituximabs karcinogene potentiale.
English: This compares favourably with the TTP achieved after the prior course of rituximab (12.4 months).
Danish: Det svarer til, hvad der blev opnået efter den første serie med rituximab (12,4 måneder).
English: In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Danish: Derimod fik tre patienter (1,5 %) cerebrovaskulære hændelser i CHOP-armen, og alle forekom i follow-up-perioden.
English: The safety profile of rituximab in patients with moderate to severe rheumatoid arthritis (RA) is summarised in the sections below.
Danish: Sikkerhedsprofilen for rituximab hos patienter med svær reumatoid artrit (RA) er sammenfattet i afsnittene nedenfor.
English: In the event of relapse, patients may receive 1000 mg IV.
Danish: I tilfælde af recidiv kan patienter gives 1.000 mg intravenøst.
English: The incidence of infections that were serious or required IV antibiotics, was approximately 4 per 100 patient years.
Danish: Hyppigheden af infektioner, som var alvorlige eller krævede i.v.-antibiotika, var ca. 4 pr. 100 patientår.
English: • The need to check, prior to Ritemvia treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Danish: • Nødvendigheden af at kontrollere for infektioner, for immunsuppression, for tidligere/nuværende medicinering, der påvirker immunsystemet, og for nylige og/eller planlagte vaccinationer før behandling med Ritemvia påbegyndes
English: No patients in the rituximab arm had fatal adverse events.
Danish: Ingen patienter i rituximab-armen havde dødelige bivirkninger.
English: • The need for patients to contact their health care professional if symptoms occur
Danish: • Nødvendigheden af, at patienterne kontakter deres læge, hvis de får symptomer
English: Nearly all infusion-related reactions were mild to moderate.
Danish: Næsten alle infusionsrelaterede reaktioner var lette til moderate.
English: The final efficacy analysis included all randomised patients (197 CHOP, 202 R-CHOP), and had a median follow-up duration of approximately 31 months.
Danish: Denne endelige effektanalyse inkluderede alle randomiserede patienter (197 CHOP, 202 R-CHOP) og den mediane opfølgningsperiode var ca. 31 måneder.
English: Table 7 Overview of efficacy results for rituximab maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Danish: Tabel 7 Oversigt over effektdata for rituximab vedligeholdelsesbehandling versus observation ved den protokol definerede primær analyse og efter 9 års median opfølgningstid (final analyse)
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy (PML)) and hepatitis C virus.
Danish: Nogle eksempler på disse alvorlige virusinfektioner er infektioner forårsaget af herpesvira (cytomegalovirus, varicella zoster virus og herpes simplex virus), JC virus (progressiv multifokal leukoencefalopati (PML)) og hepatitis C virus.
English: B cell levels in human neonates following maternal exposure to rituximab have not been studied in clinical trials.
Danish: B-celle niveauer i spædbørn efter moderen havde været eksponeret for rituximab, er ikke undersøgt i kliniske studier.
English: When Ritemvia is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Danish: Når Ritemvia gives i kombination med kemoterapi, bør standard dosisreduktioner for de kemoterapeutiske lægemidler anvendes.
English: • multiple-organ failure.
Danish: • svigt af mange organer.
English: In all patients, the infusion should not be restarted until complete resolution of all symptoms, and normalisation of laboratory values and chest X-ray findings.
Danish: For alle patienter gælder, at infusionen ikke bør startes igen, før alle symptomer er forsvundet, og laboratorieværdier og røntgenfund er normaliserede.
English: Age, gender and WHO performance status had no effect on the pharmacokinetics of rituximab.
Danish: Alder, køn, race og WHO performance status havde ingen effekt på rituximabs farmakokinetik.
English: • you have ever had or might now have a hepatitis infection.
Danish: • du nogensinde har haft leverbetændelse eller måske har leverbetændelse nu.
English: Ritemvia should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Danish: Ritemvia skal anvendes under tæt supervision af erfarent sundhedspersonale i omgivelser, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt (se pkt.
English: Although rituximab is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
Danish: Selvom rituximab ikke er myelosuppressivt ved monoterapi, bør forsigtighed udvises, når det overvejes at behandle patienter med neutrofiltal på < 1,5 x 109/l og/eller trombocyttal på < 75 x 109/l, fordi de kliniske erfaringer hos denne population er begrænsede.
English: • taste problems - such as changes in the way things taste
Danish: • smagsforstyrrelser, f.eks. at ting smager anderledes, end de plejer
English: The presence of ADA may be associated with worsening of infusion or allergic reactions after the second infusion of subsequent courses.
Danish: Forekomst af ADA kan være forbundet med forværring af infusions-eller allergiske reaktioner efter den anden infusion ved efterfølgende behandlingsserier.
English: • becoming very red in the face and other areas of the skin as a consequence of dilation of the blood vessels
Danish: • udtalt rødme i ansigtet og andre områder af huden på grund af udvidede blodkar
English: In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
Danish: I modsætning til cytokinfrigivelsessyndromet optræder egentlige allergiske reaktioner typisk indenfor minutter efter påbegyndelse af infusionen.
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Danish: Hvis der er mistanke om PML, skal behandling seponeres, indtil PML-diagnosen er udelukket.
English: B cell counts returned to normal in these animals within 6 months of birth and did not compromise the reaction to immunisation.
Danish: B-celle niveauet normaliseredes hos disse dyr indenfor 6 måneder efter fødslen og påvirkede ikke vaccinationsreaktionen.
English: Units 2100, 2110, 2010, 2120, 2130 and 2500 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY, UK
Danish: Units 2100, 2110, 2010, 2120, 2130 and 2500 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY, Storbritannien
English: Premedication and prophylactic medications
Danish: Præmedicinering og profylaktiske lægemidler
English: There were no CTC Grade 4 IRRs and no deaths due to IRRs in the clinical trials.
Danish: CTC og ingen dødsfald, som skyldtes IRR i de kliniske studier.
English: Based on the mechanism of action of rituximab and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following rituximab therapy (see section 5.1).
Danish: Baseret på rituximabs virkningsmekanisme og viden om, at B-celler spiller en vigtig rolle i at vedligeholdelsen af det normale immunrespons, kan patienterne have en øget risiko for at få en infektion efter behandling med rituximab (se pkt.
English: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to rituximab therapy.
Danish: Lægen bør gennemgå patientens vaccinationsstatus og følge gældende vaccinationsvejledninger inden igangsætning af rituximab behandling.
English: The antigen is expressed on > 95% of all B cell non-Hodgkin's lymphomas.
Danish: Antigenet udtrykkes på > 95 % af alle B-celle nonHodgkin-lymfomer.
English: 7 includes fatal cases
Danish: 7 inklusive tilfælde med dødelig udgang
English: Figure 3:
Danish: Figur 3.
English: The primary outcome measure was achievement of complete remission at 6 months defined as a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 0, and off glucocorticoid therapy.
Danish: Det primære effektmål var opnåelse af fuldstændig remission ved måned 6, defineret som en BVAS/WG-score (Birmingham Vasculitis Activity Score for Wegener's Granulomatosis) på 0 og ophørt glukokortikoidbehandling.
English: Consultation with a neurologist should be considered as clinically indicated.
Danish: Henvisning til en neurolog skal overvejes, hvis det er klinisk relevant.
English: approximately 2,400 patients received two or more courses of treatment with over 1,000 having received 5 or more courses.
Danish: Ca. 2.400 patienter fik to eller flere behandlingsserier, heraf fik over 1.000 patienter fem eller flere behandlingsserier.
English: However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with rituximab and for 12 months following rituximab treatment.
Danish: Eftersom maternelt IgG imidlertid udskilles i humanmælk, og rituximab blev detekteret i mælk fra diegivende aber, bør kvinder ikke amme, når de behandles med rituximab og i 12 måneder efter afsluttet rituximab behandling.
English: No incompatibilities between rituximab and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
Danish: Der er ikke observeret uforligeligheder mellem rituximab og polyvinylchlorid eller polyethylen infusionsposer eller infusionssæt.
English: Of the patients originally receiving methotrexate alone, 81% received rituximab either as rescue between weeks 16-24 or in the extension trial, before week 56.
Danish: Af de patienter, der i starten udelukkende fik methotrexat, fik 81 % rituximab enten som rescue-behandling i ugerne 16-24 eller i forlængelsen af studiet inden uge 56.
English: However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted post natally and was accompanied by a decrease in IgG level in the newborn animals affected.
Danish: Dog blev der observeret dosisafhængigt farmakologisk B-celle depletion i fostrets lymfatiske organer, hvilket fortsatte efter fødslen og blev fulgt af et fald i IgG niveauet hos de påvirkede nyfødte dyr.