FrancophonIA/ELRC3.0 huggingface dataset:
English: At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32%.
Danish: En efterfølgende analyse af længden af overlevelsen, udført med en median opfølgningsperiode på 60 måneder, bekræftede fordelene ved R-CHOP behandlingen i forhold til CHOP behandlingen (p = 0,0071), hvilket svarer til en risikoreduktion på 32 %.
English: Before giving a subsequent course of rituximab treatment, patients should be re-evaluated for any potential risk for infections.
Danish: Patienter bør evalueres for enhver potentiel risiko for infektioner, før der gives efterfølgende behandling med rituximab.
English: The most common IRRs included cytokine release syndrome, flushing, throat irritation, and tremor.
Danish: Blandt de hyppigst forekommende infusionsrelaterede reaktioner var cytokinfrigivelsessyndrom, ansigtsrødme, halsirritation og tremor.
English: For retreatment with Ritemvia monotherapy for patients who have responded to previous treatment with Ritemvia monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks (see section 5.1).
Danish: Til genbehandling med Ritemvia monoterapi til patienter, som har responderet på tidligere behandling med Ritemvia monoterapi for recidiveret/refraktært follikulært lymfom, er den anbefalede dosis: 375 mg/m2 legemsoverfladeareal, givet som en intravenøs infusion én gang ugentligt i 4 uger (se pkt.
English: 9.25 years log-rank p value hazard ratio (95% CI) risk reduction TNLT (median)
Danish: 9,25 år log-rank p-værdi hazard ratio (95% KI) risiko reduktion TNLT (median)
English: 3infusion-related reactions (generalised oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction)
Danish: infusions-relaterede reaktioner3 (generelt ødem, bronkospasme, hiven efter vejret, larynxødem angioødem, generaliseret kløe, anafylaksi, anafylaktoide reaktioner)
English: Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 × 500 mg dose and ranged from 21 to 22 days for the 2 × 1000 mg dose.
Danish: Efter anden infusion i den anden behandlingsserie var den gennemsnitlige terminale halveringstid for elimination 19 dage for doseringsgruppen 2 x 500 mg og varierede fra 21 til 22 dage for doseringsgruppen 2 x 1.000 mg.
English: Skin and Subcutaneous tissue disorders pruritus, rash, +alopecia urticaria, sweating, night sweats, +skin disorder severe bullous skin reactions, StevensJohnson syndrome toxic epidermal necrolysis (Lyell's syndrome)7
Danish: Hud og subkutane væv kløe, udslæt, +alopeci urticaria, svedtendens, nattesved, +hudsygdomme svære bulløse hud-reaktioner, StevensJohnsons syndrom, toksisk epidermal nekrolyse (Lyells syndrom)7
English: Skin and subcutaneous tissue disorders alopecia toxic epidermal necrolysis (Lyell's syndrome), StevensJohnson syndrome5
Danish: Toksisk epidermal nekrolyse (Lyells syndrom), StevensJohnsons syndrom5
English: Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped.
Danish: Fortæl det straks til den person, der giver dig infusionen, hvis du oplever nogle af disse symptomer,
English: Rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris
Danish: Reumatoid artrit, granulomatose med polyangiitis, mikroskopisk polyangiitis og pemfigus vulgaris
English: heart failure4
Danish: nedsat IgGniveauer4
English: Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of rituximab maintenance therapy in terms of PFS, EFS, TNLT and TNCT (Table 7).
Danish: Resultaterne af forlænget opfølgning af patienterne i studiet (median observationstid 9 år) bekræftede langtidseffekterne af rituximab vedligeholdelsesbehandling i forhold til progressionsfri overlevelse, hændelsesfri overlevelse, tid til næste anti-lymfom-behandling og tid til næste kemoterapibehandling (tabel 7).
English: Gastrointestinal disorders dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Danish: Mave-tarm-kanalen dyspepsi, diarré, gastroøsofageal refluks, ulceration i munden, smerter i øvre del af abdomen
English: Table 9 Maintenance phase: overview of efficacy results rituximab vs. observation (28 months median observation time)
Danish: Tabel 9 Vedligeholdelsesfase: Oversigt over effektdata for rituximab versus observation
English: The infusion rate may be increased upon improvement of symptoms.
Danish: Ved bedring af symptomerne kan infusionshastigheden øges.
English: Corticosteroids given by mouth may be started at any time by your doctor to treat your condition.
Danish: Lægen kan give dig binyrebarkhormon-tabletter på et hvilket som helst tidspunkt for at behandle din tilstand.
English: Experience from granulomatosis with polyangiitis and microscopic polyangiitis
Danish: Erfaring fra granulomatose med polyangiitis og mikroskopisk polyangiitis
English: 3infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
Danish: Immunsystemet infusions-relaterede reaktioner3 (hypertension, kvalme, udslæt, pyreksi, kløe, urticaria, halsirritation, hedeture, hypotension, rhinitis, kulderystelser, takykardi, træthed, orofaryngeale smerter, perifert ødem, erytem)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: A small number of spontaneous and literature cases of hypogammaglobulinaemia have been observed in paediatric patients treated with rituximab, in some cases severe and requiring long-term immunoglobulin substitution therapy.
Danish: Der er observeret et mindre antal spontane og kasuistiske tilfælde af hypogammaglobulinæmi hos pædiatriske patienter behandlet med rituximab.
English: Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in autoimmune conditions.
Danish: Tilfælde af posterior reversibel encefalopati syndrom (PRES)/reversibel posterior leukoencefalopati syndrom (RPLS) er blevet rapporteret ved autoimmune sygdomme.
English: log-rank p value hazard ratio (95% CI) risk reduction TNCT (median)
Danish: log-rank p-værdi hazard ratio (95% KI) risiko reduktion TNCT (median)
English: infusion site pain
Danish: smerter på infusionssted et
English: Therefore, in patients with a known cardiac history, and those who experienced prior cardiopulmonary adverse reactions the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with rituximab and patients closely monitored during administration.
Danish: Derfor bør risikoen for, at infusionen kan føre til kardiovaskulære komplikationer, overvejes før behandling med rituximab hos patienter med kendte hjerteproblemer i anamnesen og hos patienter, som tidligere har oplevet kardiopulmonære bivirkninger.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab.
Danish: Tilfælde af hepatitis B-reaktivering, herunder letale tilfælde, er rapporteret hos patienter med reumatoid artrit, GPA og MPA, som fik rituximab.
English: +myocardial infarction4 and 6, arrhythmia, +atrial fibrillation,
Danish: +myokardieinfarkt 4 og 6, arytmier, +atrieflimren, takykardi, +hjertesygdom
English: p-value a
Danish: p-værdi a konfidensinterval b
English: Rituximab +MTX 2 × 1000 mg
Danish: Placebo+MTX Rituximab +MTX 2 × 1.000 mg
English: There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following rituximab (see section 4.5).
Danish: Sikkerheden af sekventiel brug af andre DMARDs (inklusive TNF-inhibitorer og andre biologiske lægemidler) efter behandling med rituximab er kun undersøgt i begrænset omfang i kliniske studier og kan ikke vurderes fuldstændigt (se pkt.
English: Table 2 Summary of adverse drug reactions reported in clinical trials or during post-marketing surveillance occurring in patients with rheumatoid arthritis receiving rituximab
Danish: Tabel 2 Opsummering af bivirkningsreaktioner hos patienter med reumatoid artrit, som fik rituximab i kliniske studier eller i forbindelse med post-marketing overvågning.
English: Cytokine release syndrome
Danish: Cytokinfrigivelsessyndrom
English: Number of Subjects with Major Relapse
Danish: Antal af patienter med større recidiv
English: Cmax following second infusion, was 207 μg/mL for the 2 × 500 mg dose and ranged from 377 to 386 μg/mL for the 2 × 1000 mg dose.
Danish: Efter den anden infusion var gennemsnittet for Cmax 270 μg/ml for doseringen på 2 x 500 mg og varierede fra 377 til 386 μg/ml for doseringen på 2 x 1.000 mg.
English: General disorders and administratio n site conditions fever, chills, asthenia, headache tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering, +multi-organ failure4
Danish: Almene symptomer og reaktioner på administrationsste det feber, kulderystelser, asteni, hovedpine tumorsmerter, hedeture, utilpashed, kuldesyndrom, +træthed, +kulderystelser, +multiorgan-svigt4
English: 6 observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly associated with infusion-related reactions
Danish: 6 Fortrinsvis set hos patienter med tidligere hjertesygdom og/eller kardiotoksisk kemoterapi.
English: The recommended dose of Ritemvia monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks.
Danish: Den anbefalede dosis af Ritemvia monoterapi til induktionsbehandling hos voksne patienter med grad III-IV follikulært lymfom, som er resistente over for behandling med kemoterapi eller som er i deres anden eller efterfølgende recidiv efter kemoterapi, er 375 mg/m2 legemsoverfladeareal, givet som intravenøs infusion én gang ugentligt i 4 uger.
English: Mean change from baseline: Modified total sharp score Erosion score Joint space narrowing score Proportion of patients with no radiographic change
Danish: Gennemsnitsændring fra baseline: Modificeret Total Sharp Score
English: 3 see also section haematologic adverse reactions below
Danish: 3 se også afsnittet om hæmatologiske bivirkninger herunder
English: Worst case imputation is applied for patients with missing data
Danish: For de patienter, hvor der mangler data, ekstrapoleres ud fra det værst tænkelige scenarie.
English: The recommended dose of Ritemvia used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
Danish: • Recidiveret/ refraktært follikulært lymfom Den anbefalede dosis af Ritemvia til vedligeholdelsesbehandling hos patienter med recidiveret/ refraktært follikulært lymfom, som har responderet på induktionsbehandling, er 375 mg/m2 legemsoverfladeareal én gang hver 3. måned (startende 3 måneder efter den sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (8 infusioner i alt).
English: log-rank p value hazard ratio (95% CI) risk reduction
Danish: log-rank p-værdi hazard ratio (95% KI) risiko reduktion
English: late neutropenia3
Danish: sen neutropeni3
English: • blocked or runny nose
Danish: • stoppet eller løbende næse
English: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 μg/mL for 2 × 500 mg dose and ranged from 298 to 341 μg/mL for 2 × 1000 mg dose.
Danish: Efter første infusion varierede gennemsnittet for Cmax for serum-rituximab fra 157 til 171 μg/ml for doseringen på 2 x 500 mg og fra 298 til 341 μg/ml for doseringen på 2 x 1.000 mg.
English: • skin rashes, including acne or spots
Danish: • udslæt, inklusive akne eller uren hud
English: In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
Danish: I et åbent, randomiseret studie blev 322 tidligere ubehandlede patienter med follikulært lymfom randomiseret til enten CVP-kemoterapi (cyklophosphamid 750 mg/m2, vincristin 1,4 mg/m2 op til maksimalt 2 mg på dag 1 og prednisolon 40 mg/m2 på dag 1-5) hver 3. uge i 8 serier eller til rituximab 375 mg/m2 i kombination med CVP (R-CVP).
English: Clinical experience in non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Danish: Klinisk erfaring ved non-Hodgkin-lymfom og kronisk lymfatisk leukæmi
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 × 500 mg dose and 317 to 370 μg/mL for 2 × 1000 mg dose.
Danish: Efter første infusion varierede gennemsnittet for Cmax for serum-rituximab fra 170 til 175 μg/ml for doseringen på 2 x 500 mg og fra 317 til 370 μg/ml for doseringen på 2 x 1.000 mg.
English: • tight or painful muscles
Danish: • muskelkramper eller ømme muskler
English: Cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome.
Danish: Tilfælde af hepatitis B-reaktivering, herunder tilfælde af fulminant hepatitis med dødelig udgang, er blevet rapporteret hos patienter, der har fået rituximab.
English: • feeling tired or dizzy
Danish: • træthed og svimmelhed
English: - CI = confidence interval.
Danish: Forskel (konfidensinterval
English: Overall response rate* chi-squared test p value odds ratio (95% CI)
Danish: Samlet respons rate* chi-i-anden-test p-værdi odds ratio (95% KI) Komplet respons (CR/CRu) rate* chi-i-anden-test p-værdi odds ratio (95% KI)
English: IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with those seen for rheumatoid arthritis patients in clinical trials (see section 4.8).
Danish: Infusionsrelaterede reaktioner hos patienter med GPA, MPA og PV var i overensstemmelse med dem, der sås i kliniske studier med patienter med reumatoid artrit (se pkt.
English: However, a large component of inter-individual variability remained for CL2 after correction for CD19-positive cell counts and tumour lesion size.
Danish: Selvom der korrigeredes for CD-19 positive celletal og størrelsen af tumorbyrde, var der stadig store interindividuelle variationer i CL2 V1 varierede i forhold til kroppens overfladeareal og CHOP kemoterapi.
English: Physician information
Danish: Information til lægen
English: Pemphigus vulgaris
Danish: Pemfigus vulgaris
English: b) Granulomatosis with polyangiitis or microscopic polyangiitis
Danish: b) Granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: During this time, 81% of patients, from the original placebo group received rituximab between weeks 24 and 56, under an open label extension study protocol.
Danish: I løbet af perioden mellem uge 24 og uge 56 blev 81 % af de oprindelige placebopatienter behandlet med rituximab.
English: Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Danish: 4.3) eller til alvorligt immunkompromitterede patienter (for eksempel hvor CD4- eller CD8-niveauerne er meget lave).
English: These reactions are less likely to happen after the second infusion.
Danish: Ved de efterfølgende infusioner vil hyppigheden af disse reaktioner være mindre.
English: Your doctor may decide to stop your Ritemvia treatment if these reactions are serious.
Danish: Hvis disse reaktioner er alvorlige, kan lægen vælge at stoppe behandlingen med Ritemvia.
English: Granulomatosis with polyangiitis and microscopic polyangiitis
Danish: Granulomatose med polyangiitis og mikroskopisk polyangiitis
English: • memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare,
Danish: • hukommelsestab, koncentrationsbesvær, besvær med at gå eller synstab - dette kan skyldes en meget sjælden, alvorlig hjerneinfektion, der i nogle tilfælde har været dødelig (progressiv multifokal leukoencefalopati eller PML).
English: Rituximab N=505
Danish: N=505
English: • infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections,
Danish: • infektioner i blodet (sepsis), lungebetændelse, helvedesild, forkølelse, infektion i bronkierne, svampeinfektioner, infektioner af ukendt oprindelse, bihulebetændelse, leverbetændelse (hepatitis B)
English: Patient Alert card
Danish: Patientkort
English: Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171 - 1177 µg/mL) after the eighth infusion.
Danish: Efter hver infusion steg den gennemsnitlige Cmax, fra et gennemsnit på 243 µg/ml (spændvidde 16-582 µg/ml) efter den første infusion til 550 µg/ml (spændvidde 171-1177 µg/ml) efter den ottende infusion.
English: inflammation, irritation in the lungs, throat or sinuses, being short of breath, runny nose
Danish: (bronkospasme), inflammation (betændelseslignende reaktion), irritation i lungerne, halsen eller bihulerne, åndenød, løbende næse
English: In Trial 1, conducted in patients with inadequate response or intolerance to one or more TNF inhibitor therapies, receiving rituximab in combination with methotrexate demonstrated significantly less radiographic progression than patients originally receiving methotrexate alone at 56 weeks.
Danish: Patienter, som fik rituximab i kombination med methotrexat, udviste i uge 56 signifikant mindre radiologisk progression end patienter, der i starten udelukkende havde fået methotrexat.
English: Experience from non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
Danish: Erfaringer fra non-Hodgkin-lymfom og kronisk lymfatisk leukæmi
English: Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of patients in clinical trials, and were predominantly seen during the first infusion, usually in the first one to two hours.
Danish: Der blev beskrevet symptomer på infusionsrelateret reaktion hos mere end 50 % af patienterne i de kliniske studier.
English: Ritemvia 500 mg concentrate for solution for infusion Rituximab
Danish: Ritemvia 500 mg, koncentrat til infusionsvæske, opløsning Rituximab
English: Ritemvia 100 mg concentrate for solution for infusion Rituximab
Danish: Ritemvia 100 mg, koncentrat til infusionsvæske, opløsning Rituximab
English: Rituximab infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.
Danish: Rituximab-infusionen blev indgivet efter administration af en intravenøs infusion af 100 mg methylprednisolon.
English: Name:_______________________ Doctor's contact details:________________ Make sure you have a list of all your medicines when you see a health care professional.
Danish: Sørg for altid at have en liste over al din medicin med til ethvert besøg hos lægen eller andet sundhedspersonale.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Ritemvia infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Danish: Hos patienter med GPA eller MPA i sygdomsremission eller PV, bør præmedicinering i form af 100 mg methylprednisolon i.v.
English: Please see cytokine release syndrome above for severe reactions.
Danish: Ved alvorlige reaktioner se cytokinfrigivelsessyndrom ovenfor.
English: Rituximab was administered as an intravenous infusion at a first-cycle dose of 375 mg/m2 increased to 500 mg/m2 each cycle for 5 doses in combination with fludarabine and cyclophosphamide in CLL patients.
Danish: I kombination med fludarabin og cyclophosphamid blev rituximab givet til CLL-patienter som en intravenøs infusion i en dosis på 375 mg/m2 ved første behandlingsserie og øget til en dosis på 500 mg/m2 for hver af de 5 efterfølgende behandlingsserier.
English: Hypertension Flushing
Danish: Hypertension Ansigtsrødme
English: a) Non-Hodgkin's Lymphoma
Danish: a) Non-Hodgkin-lymfom
English: No patients were withdrawn due to ADRs.
Danish: Ingen patienter udgik af studiet på grund af bivirkninger.
English: All patients Newly diagnosed Relapsing n=99 n=48 n=51
Danish: Patienter med recidiv n = 51
English: In addition to adverse reactions seen in RA clinical trials for rituximab, progressive multifocal leukoencephalopathy (PML) (see section 4.4) and serum sickness-like reaction have been reported during post marketing experience.
Danish: Ud over de bivirkninger, som er set i kliniske studier af RA med rituximab, er progressiv multifokal leukoencefalopati (PML) (se pkt.
English: in the blood which help protect against infection
Danish: • lavt immunforsvar, fordi indholdet af antistoffer i blodet, som beskytter mod infektion,
English: ACR70 EULAR Response (Good/Moderate)
Danish: ACR20 (%) ACR50 (%) ACR70 (%) EULAR-respons (%) Gennemsnitsændring DAS28-ESR
English: On the basis of limited experience with rituximab in rheumatoid arthritis patients (see section 4.8) the present data do not seem to suggest any increased risk of malignancy.
Danish: 4.8) tyder de nuværende data ikke på nogen øget risiko for malignitet.
English: Ritemvia 500 mg concentrate for solution for infusion
Danish: Ritemvia 500 mg koncentrat til infusionsvæske, opløsning
English: Adverse drug reaction rituximab + low-dose prednisone (n=38)
Danish: Rituximab + lavdosis prednison (n = 38)
English: Severe skin reactions such as Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported (see section 4.8).
Danish: 4.8), såsom toksisk epidermal nekrolyse (Lyells syndrom) og Stevens-Johnsons syndrom, hvoraf nogle havde dødelig udgang.
English: • headache
Danish: • hårtab
English: Treatment of relapse
Danish: Behandling af recidiv
English: Cardiac disorders angina pectoris, atrial fibrillation, heart failure,
Danish: Eksacerbationer af hjertelidelser som angina pectoris, kongestiv hjertesygdom eller alvorlige kardielle sygdomme
English: • coughing or shortness of breath
Danish: • hoste eller kortåndethed