FrancophonIA/ELRC3.0 huggingface dataset:
English: This is mostly accounted for by IRRs (most frequent during the first treatment course), RA exacerbation and infections all of which were more frequent in the first 6 months of treatment.
Danish: Dette kan hovedsageligt tilskrives infusionsrelaterede reaktioner (hyppigst under første behandlingsserie), reumatoid artrit-eksacerbation og infektioner, som alle var hyppigere i de første 6 måneder af behandlingen.
English: • allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
Danish: • allergiske reaktioner, som normalt forekommer under infusionen, men kan forekomme i op til 24 timer efter infusion
English: Event free survival Response rate (CR, nPR, or PR)
Danish: Hændelsesfri overlevelse Responsrate (CR, nPR eller PR)
English: Ritemvia should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Danish: Ritemvia bør gives på dag 1 i hver kemoterapiserie, efter intravenøs indgift af glukokortikoidkomponenten, hvis det anvendes.
English: Rituximab was administered as two IV infusions separated by an interval of 15 days.
Danish: Rituximab blev administreret som to i.v.-infusioner med et interval på 15 dage.
English: Rarely Ritemvia can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Danish: Ritemvia har i sjældne tilfælde forårsaget en alvorlig hjerneinfektion, som kaldes ”Progressiv multifokal leukoencefalopati” (PML).
English: Neutropenia can occur several months after the administration of rituximab (see section 4.4).
Danish: Neutropeni kan forekomme flere måneder efter indgivelse af rituximab (se pkt.
English: The highest intravenous dose of rituximab tested in humans to date is 5000 mg (2250 mg/m2), tested in a dose escalation study in patients with CLL.
Danish: Den højeste intravenøse rituximab-dosis, der til dato er testet hos mennesker, er 5.000 mg (2.250 mg/m2), som er testet i et dosis-eskaleringsstudie med patienter med kronisk lymfocytisk leukæmi.
English: Contraception in males and females
Danish: Prævention hos mænd og kvinder
English: Rituximab has shown to be highly specific to the CD20 antigen on B cells.
Danish: Rituximab er vist at være yderst specifikt overfor CD20 antigenet på B-celler.
English: Neutropenia was not associated with an observed increase in serious infection in rituximab-treated patients.
Danish: Neutropeni var ikke forbundet med en øget frekvens af alvorlige infektioner blandt rituximabbehandlede patienter.
English: Rituximab maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, ≥ 60 years), FLIPI score (≤1, 2 or ≥ 3), induction therapy (RCHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
Danish: Rituximab vedligeholdelsesbehandling gav konsekvent fordel i alle testede prædefinerede undergrupper: Køn (mand, kvinde), alder (< 60 år, ≥ 60 år), FLIPI-score (≤ 1, 2 eller ≥ 3), induktionsbehandling (R-CHOP, R-CVP eller R-FCM) og uanset kvaliteten af respons på induktionsbehandling (CR, CRu eller PR).
English: Infusion-related reactions*
Danish: Infusionsrelaterede reaktioner*
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: Dizziness Tremor
Danish: Svimmelhed Tremor
English: Rituximab maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p< 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Danish: Rituximab-vedligeholdelsesbehandling forlængede signifikant den mediane PFS hos patienter, der responderede på CHOP-induktionsbehandling (median PFS 37,5 måneder versus 11,6 måneder, p< 0,0001) såvel som hos dem, der responderede på R-CHOP induktionsbehandling (median PFS 51,9 måneder versus 22,1 måneder, p = 0,0071).
English: It sticks to the surface of a type of white blood cell called “B-Lymphocyte”.
Danish: Det binder sig til overfladen på de hvide blodlegemer, der kaldes B-lymfocytter.
English: • The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.
Danish: • Nødvendigheden af at advare patienterne om risikoen for infektioner og PML, inklusive symptomerne, så patienterne kender disse og er klar over, at de straks skal kontakte deres læge, hvis de oplever nogen symptomer
English: EULAR Response (%)
Danish: Antallet af respondenter (respons-rate (%))
English: In the maintenance therapy clinical trial, no clinically meaningful differences between the two treatment arms or decreases in total immunoglobulin, IgG, IgM or IgA levels were observed throughout the trial.
Danish: I det kliniske studie med vedligeholdelsesbehandling blev ingen klinisk relevante forskelle observeret mellem de to behandlingsarme eller i fald af total immunoglobulin, IgG-, IgM- eller IgA-niveauer under studiet.
English: Number of responders (response rate [%]) a p-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Danish: ap-værdi er fra Fisher's exact test med mid-p korrektion b95 % konfidensinterval er korrigeret Newcombe interval
English: Results from three other randomised trials using rituximab in combination with chemotherapy regimen other than CVP (CHOP, MCP, CHVP/Interferon-α) have also demonstrated significant improvements in response rates, time-dependent parameters as well as in overall survival.
Danish: Resultaterne fra tre andre randomiserede studier, hvor rituximab blev anvendt i kombination med andre kemoterapibehandlinger end CVP (CHOP, MCP, CHVP/Interferon-α), har også vist signifikante forbedringer i responsrater, tidsafhængige parametre samt samlet overlevelse.
English: Following induction of remission with Ritemvia, maintenance treatment should be initiated no sooner than 16 weeks after the last Ritemvia infusion.
Danish: Efter induktion af remission med Ritemvia skal vedligeholdelsesbehandling initieres tidligst 16 uger efter sidste Ritemvia infusion.
English: During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles), four patients (2%) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Danish: I behandlingsperioden (induktionsbehandlingsfasen bestående af R-CHOP i højst 8 behandlingsserier) fik fire patienter (2 %) i R-CHOP-armen, alle med kardiovaskulære risikofaktorer, tromboemboliske cerebrovaskulære hændelser i den første behandlingsserie.
English: The overall safety profile was consistent with the well-established safety profile of rituximab in RA and GPA/MPA and no new adverse drug reactions were reported.
Danish: Den overordnede sikkerhedsprofil var i overensstemmelse med den i forvejen fastlagte sikkerhedsprofil for rituximab i rheumatoid artrit og GPA/MPA, og ingen nye bivirkninger blev rapporteret.
English: Cytokine release syndrome may be clinically indistinguishable from acute hypersensitivity reactions.
Danish: Cytokinfrigivelsessyndrom kan klinisk være umuligt at skelne fra akutte overfølsomhedsreaktioner.
English: Table 18 Percentage of PV patients who achieved complete remission off corticosteroid therapy for two months or more at month 24 (Intent-to-Treat Population - PV)
Danish: Tabel 18 Procentdel af patienter med PV, som opnåede fuldstændig remission uden kortikoid-behandling i to eller flere måneder ved måned 24 (ITT-populationPV)
English: Risk reduction1)
Danish: Risikoreduktion1)
English: Haematological toxicities
Danish: Hæmatologisk toksicitet
English: If you are being treated for granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor.
Danish: Hvis du behandles for granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris vil du også finde denne information i patientkortet, som du har fået af lægen.
English: Persistent depressive disorder Major depression Irritability
Danish: Vedvarende depressiv lidelse Svær depression Irritabilitet
English: A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to rituximab maintenance therapy (n=167) or observation (n=167).
Danish: De i alt 334 patienter, der opnåede komplet eller partiel remission efter induktionsbehandlingen, blev efterfølgende randomiseret til rituximab-vedligeholdelsesbehandling (n = 167) eller observation (n = 167).
English: The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Danish: I de rapporterede tilfælde var der kendte risikofaktorer for PRES/RPLS, herunder patientens underliggende sygdom, hypertension, immunsuppressiv behandling og/eller kemoterapi.
English: IgG immunoglobulins are known to cross the placental barrier.
Danish: Det vides, at IgG-immunglobuliner kan passere placentabarrieren.
English: The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3-15).
Danish: Hyppigheden af alvorlige kardielle bivirkninger var 2,1 pr. 100 patientår (95 % konfidensinterval 3-15).
English: The most commonly reported serious infection in the rituximab group was mild or moderate bronchitis.
Danish: Den mest almindelige, alvorlige infektion rapporteret i rituximab-gruppen var let eller moderat bronkitis.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with autoimmune arthritis.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med rituximab i alle undergrupper af den pædiatriske population med autoimmun artrit (se pkt.
English: Maintenance infusions of rituximab 500 mg were administered at months 12 and 18.
Danish: En vedligeholdelsesinfusion af rituximab 500 mg blev administreret ved måned 12 og 18.
English: Tell your doctor or nurse if you are taking or have previously taken medicines which may affect your immune system this includes chemo-therapy.
Danish: Fortæl din læge eller sygeplejerske, hvis du får eller tidligere har fået medicin, som kan påvirke dit immunsystem.
English: The incidence, types and severity of IRRs were consistent with that observed historically.
Danish: Incidensen, typen og sværhedsgraden af infusionsrelaterede reaktioner var konsistent med, hvad der tidligere var observeret.
English: Patients in the rituximab group who relapsed could receive an additional infusion of rituximab 1000 mg in combination with reintroduced or escalated prednisone dose.
Danish: Patienter i rituximab-gruppen, som oplevede recidiv, kunne få en yderligere infusion med rituximab 1.000 mg i kombination med genindført eller optitreret prednison-dosis.
English: Median EFS: 36 Not reached p < 0.0001
Danish: Median EFS: 36 Ikke opnået p < 0,0001
English: Patient information
Danish: Information til patienten
English: After a median observation time of 31 months for patients randomised to the induction phase, R-CHOP significantly improved the outcome of patients with relapsed/refractory follicular lymphoma when compared to CHOP (see Table 8).
Danish: Efter en median observationstid på 31 måneder for patienter randomiseret til induktionsfasen forbedrede R-CHOP signifikant udfaldet af recidiveret/ refraktært follikulært lymfom i sammenligning med CHOP (se tabel 8).
English: Musculoskeletal pain
Danish: Muskuloskeletal smerte
English: A diagnosis of PRES/RPLS requires confirmation by brain imaging.
Danish: Diagnosen PRES / RPLS kræver bekræftelse ved en hjernescanning.
English: The overall rate of infection was approximately 94 per 100 patient years in rituximab treated patients.
Danish: Den samlede hyppighed af infektioner var ca. 94 pr. 100 patientår hos patienter behandlet med rituximab.
English: Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, UK
Danish: Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, Storbritannien
English: Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with rituximab.
Danish: Gennemsnittet af præterapeutiske antistoftitere for et udvalg af antigener (Streptococcus pneumoniae, influenza A, mæslinger, røde hunde, skoldkopper) blev bibeholdt i mindst 6 måneder efter behandling med rituximab.
English: Kaplan-Meier estimate of median time to event (months)
Danish: Kaplan-Meier estimat for den mediane tid til hændelsen (måneder)
English: What you need to know before you use Ritemvia Do not take Ritemvia if:
Danish: Det skal du vide, før du begynder at få Ritemvia Du må ikke få Ritemvia, hvis:
English: The Patient Alert Card for Ritemvia in non-oncology indications should contain the following key elements:
Danish: Patientkortet for Ritemvia for non-onkologiske indikationer skal indeholde følgende nøgle-elementer:
English: These symptoms mainly comprised fever, chills and rigors.
Danish: Bivirkningerne omfattede fortrinsvis feber, kulderystelser og rigor.
English: The most frequently reported events were tachycardia (4%) and atrial fibrillation (3%) (see section 4.4).
Danish: De hyppigst rapporterede bivirkninger var takykardi (4 %) og atrieflimren (3 %) (se pkt.
English: 4.04 years
Danish: 4,04 år
English: In a trial designed to evaluate the safety of a more rapid rituximab infusion in patients with rheumatoid arthritis, patients with moderate-to-severe active RA who did not experience a serious IRR during or within 24 hours of their first studied infusion were allowed to receive a 2-hour intravenous infusion of rituximab.
Danish: I et studie designet til at evaluere sikkerheden af en hurtigere rituximab-infusion hos patienter med reumatoid artrit kunne patienter med moderat til svær aktiv reumatoid artrit, som ikke havde oplevet en alvorlig infusionsrelateret reaktion under eller inden for 24 timer efter deres første infusion, få en 2 timers intravenøs rituximab-infusion.
English: Ritemvia is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Danish: Ritemvia er indiceret til behandling af tidligere ubehandlede patienter med stadium III-IV follikulært lymfom i kombination med kemoterapi.
English: Cyclophosphamide (n = 98)
Danish: Cyclophosphamid (n = 98)
English: Patients with a history of pulmonary insufficiency or those with pulmonary tumour infiltration may be at greater risk of poor outcome and should be treated with increased caution.
Danish: Patienter med tidligere lungesvigt eller patienter med pulmonal tumor infiltration kan have større risiko for ikke at tåle behandlingen og bør behandles med ekstra forsigtighed.
English: Measure blood neutrophils prior to each course of rituximab, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Danish: Neutrofiltælling bør foretages inden hver rituximab behandlingsserie og regelmæssigt op til 6 måneder efter afsluttet behandling, samt ved tegn på infektion (se pkt.
English: cranial neuropathy, loss of other senses5
Danish: kraniel neuropati, tab af andre sanser5
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p=0.0319, log-rank test) (Table 10a).
Danish: Analyse af samlet overlevelse viste fortsat en signifikant fordel ved R-FC-behandling i forhold til FCkemoterapi (p = 0,0319, log-rank test) (tabel 10a).
English: Median PFS: 28.8 Not reached p < 0.0001
Danish: Median PFS: 28,8 Ikke opnået p < 0,0001
English: The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest X-ray.
Danish: Det akutte respirationssvigt kan ledsages af f.eks. interstitiel lungeinfiltration eller lungeødem som kan ses på røntgen af thorax.
English: A total of 117 patients (88 with GPA, 24 with MPA, and 5 with renal-limited ANCA-associated vasculitis) in disease remission were randomised to receive azathioprine (59 patients) or rituximab (58 patients) in a prospective, multi-center, controlled, open-label study.
Danish: I alt 117 patienter (88 med GPA, 24 med MPA og 5 med nyre-begrænset antineutrofil cytoplasmisk antistof (ANCA)-associeret vaskulitis) i sygdomsremission blev randomiseret til at få henholdsvis azathioprin (59 patienter) eller rituximab (58 patienter) i et prospektiv, kontrolleret, åbent multicenterstudie.
English: Results from other supportive studies using rituximab in combination with other chemotherapy regimens (including CHOP, FCM, PC, PCM, bendamustine and cladribine) for the treatment of previously untreated and/or relapsed/refractory CLL patients have also demonstrated high overall response rates with benefit in terms of PFS rates, albeit with modestly higher toxicity (especially myelotoxicity).
Danish: Resultater fra andre støttende studier, som anvendte rituximab i kombination med andre kemoterapiregimer (herunder CHOP, FCM, PC og PCM, bendamustin og cladribin) til behandling af tidligere ubehandlede og/eller relaps/refraktære CLL-patienter, har også vist høje totale responsrater med fordele i form af PFS-rater om end med moderat højere toksicitet (specielt myelotoksicitet).
English: The proportions of rituximab treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of >0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Danish: Andelen af patienter behandlet med rituximab, som viste minimal klinisk relevant ændring (MCID) i HAQ-DI (defineret som et fald i individuel total score på > 0,22) var også højere end hos patienter, som fik methotrexat alene (tabel 14).
English: Patients should be closely monitored for the onset of cytokine release syndrome (see section 4.4).
Danish: Patienter skal nøje monitoreres for cytokinfrigivelsessyndrom (se pkt.
English: Subsequent infusions may be administered no sooner than 16 weeks following the previous infusion.
Danish: Efterfølgende infusioner skal ikke administreres senere end 16 uger efter den tidligere infusion.
English: The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients (< 65 years), with previously untreated or relapsed/refractory CLL.
Danish: Hyppigheden af grad 3/4 bivirkninger i blod og lymfesystemet var højere hos ældre patienter med tidligere ubehandlet eller relaps/refraktær CLL, sammenlignet med hos yngre patienter (< 65 år).
English: 4 see also section infusion-related reactions below.
Danish: 4 se også afsnittet om infusionsrelaterede reaktioner herunder.
English: This set of reactions which includes syndrome of cytokine release, tumour lysis syndrome and anaphylactic and hypersensitivity reactions are described below.
Danish: Det sæt af reaktioner, der omfatter cytokinfrigivelsessyndrom, tumorlysesyndrom samt anafylaktiske reaktioner og overfølsomhedsreaktioner beskrives nedenfor.
English: Developmental toxicity studies have been performed in cynomolgus monkeys at doses up to 100 mg/kg (treatment on gestation days 20-50) and have revealed no evidence of toxicity to the foetus due to rituximab.
Danish: Prækliniske toksicitetsstudier i forbindelse med reproduktion udført i cynomolgusaben i doser på op til 100 mg/kg (behandling på dagene 20-50 i graviditeten) og har ikke vist tegn på føtal toksicitet af rituximab.
English: In the induction of remission clinical trial, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Danish: I det kliniske forsøg med induktion af remission udviklede 24 % af patienterne i rituximab-gruppen (ét forløb) og 23 % af patienterne i cyclophosphamid-gruppen neutropeni af CTC-grad 3 eller derover.
English: In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC 71%).
Danish: I CLL 1. linjestudiet oplevede Binet C patienter i R-FC-armen flere bivirkninger sammenlignet med patienter i FC-armen (R-FC 83 % versus FC 71 %).
English: • you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
Danish: • du har svært nedsat hjertefunktion eller svær, ukontrolleret hjertesygdom og har granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris.
English: Subsequent doses of Ritemvia can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Danish: Efterfølgende Ritemvia-doser kan infunderes med 100 mg/time initialt og øges med 100 mg/time hvert 30. minut til højst 400 mg/time.
English: For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+" where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
Danish: Hyppigheden var baseret på alle bivirkninger, uanset sværhedsgrad (fra lette til alvorlige bivirkninger), bortset fra bivirkninger, som er markeret med “+”, hvor hyppigheden kun er baseret på alvorlige bivirkninger (NCI common toxicity criteria ≥ grad 3).
English: In clinical trials with rituximab monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
Danish: I de kliniske studier med rituximab-monoterapi givet i 4 uger forekom hæmatologiske bivirkninger hos en minoritet af patienterne; bivirkningerne var sædvanligvis lette og reversible.
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP
Danish: Tabel 8 Induktionsfase: Oversigt over effektdata for CHOP versus R-CHOP (31 måneders median observationstid) CHOP
English: How much and how often you will receive your treatment a)
Danish: Hvor meget medicin skal du have og hvor ofte?
English: The overall response rate (ORR) in the intent-to-treat (ITT) population was 48% (CI95% 41% - 56%) with a 6% complete response (CR) and a 42% partial response (PR) rate.
Danish: Den samlede responsrate i intent-to-treat populationen var 48 % (95 % konfidensinterval: 41 %56 %) med 6 % komplet respons (CR) og 42 % partielt respons (PR).
English: Your doctor may need to take special care of you during your treatment with Ritemvia.
Danish: Du kan have behov for ekstra overvågning under din behandling med Ritemvia.
English: In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg rituximab separated by a 14 day interval.
Danish: Hos patienter med reumatoid artrit sås øjeblikkelig B-celle depletering i perifert blod efter to infusioner af 1.000 mg rituximab med 14 dages interval.
English: Cases of hepatitis B reactivation, have been reported, the majority of which were in patients receiving rituximab in combination with cytotoxic chemotherapy.
Danish: Der er rapporteret om tilfælde af reaktivering af hepatitis B, hvoraf de fleste forekom hos patienter, som fik rituximab i kombination med cytotoksisk kemoterapi.
English: Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease (see section 4.4 regarding other cardiovascular diseases).
Danish: Alvorlig hjerteinsufficiens (New York Heart Association klasse IV) eller alvorlig, ukontrolleret hjertesygdom (se pkt.