FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Ritemvia (the last dose of methylprednisolone may be given on the same day as the first infusion of Ritemvia).
Danish: Hos patienter med GPA eller MPA anbefales det at give methylprednisolon intravenøst i 1-3 dage i en dosis på 1000 mg pr. dag inden den første Ritemvia-infusion (sidste dosis methylprednisolon kan gives samme dag som første Ritemvia-infusion).
English: Maintenance doses of 500 mg IV were administered at months 12 and 18.
Danish: En vedligeholdelsesdosis på 500 mg intravenøst blev administreret ved måned 12 og 18.
English: Treatment with R-CVP significantly prolonged the time to disease progression or death compared to CVP, 33.6 months and 14.7 months, respectively (p < 0.0001, log-rank test).
Danish: Behandling med R-CVP forlængede signifikant tiden til sygdomsprogression eller død, sammenlignet med CVP; 33,6 måneder i forhold til 14,7 måneder (p < 0,0001, log-rank test).
English: The efficacy and safety of rituximab in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study.
Danish: Effekt og sikkerhed af rituximab i kombination med kortvarig lavdosis glukokortikoid (prednison) behandling blev evalueret hos nyligt diagnosticerede patienter med moderat til svær pemfigus (74 patienter med pemfigus vulgaris (PV) og 16 med pemfigus foliaceus (PF)) i et randomiseret, åbent, kontrolleret, multicenterstudie.
English: The PK parameters of rituximab in these patients appear similar to what has been observed in rheumatoid arthritis patients.
Danish: Rituximabs farmakokinetiske parametre hos disse patienter svarede til det, der blev set hos patienter med reumatoid artrit.
English: The overall safety profile of rituximab in rheumatoid arthritis is based on data from patients from clinical trials and from post-marketing surveillance.
Danish: Den samlede sikkerhedsprofil for rituximab til behandling af reumatoid artrit stammer fra data fra kliniske studier og fra post-marketing observationer.
English: Infusion-related reactions2 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility.
Danish: 1 Hændelser blev kun betragtet som bivirkninger efter grundig vurdering og hvor en årsagssammenhæng mellem lægemidlet og bivirkningen var en rimelig mulighed.
English: Ritemvia is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Danish: Ritemvia anvendes til behandling af patienter med moderat til svær pemfigus vulgaris.
English: During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with rituximab and observation.
Danish: Under vedligeholdelsesbehandlingen var hyppigheden af hjertesygdomme af grad 3/4/ sammenlignelig mellem patienter behandlet i rituximab-gruppen og i observationsgruppen.
English: The recommended dosage of Ritemvia for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Danish: Den anbefalede dosis af Ritemvia til behandling af PV er 1.000 mg administreret som en intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion 2 uger senere i kombination med nedtitrerende glukokortikoider.
English: Following induction of remission with other standard of care immunosuppressants, Ritemvia maintenance treatment should be initiated during the 4 week period that follows disease remission.
Danish: Efter induktion af remission med andre immunsuppresiva til standardbehandling skal Ritemvia Ritemvia vedligeholdelsesbehandling initieres i løbet af en 4 ugers periode efter opnåelse af sygdomsremission.
English: The rate of overall infections and serious infections was not increased after the development of low IgA, IgG or IgM.
Danish: Hyppigheden af alle infektioner og alvorlige infektioner var ikke øget efter udvikling af lave niveauer af IgA, IgG eller IgM.
English: Ritemvia is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Danish: Ritemvia leveres i sterile, pyrogenfri hætteglas uden konserveringsmiddel til engangsbrug.
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Ritemvia (Rituximab) Alert Card for patients with non-oncology diseases Why have I been given this card?
Danish: TEKST TIL PATIENTKORT FOR IKKE-ONKOLOGISKE INDIKATIONER Ritemvia (Rituximab)-patientkort for ikkeonkologiske indikationer
English: Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among rituximab-treated PV patients, with a ≥ 2% absolute difference in incidence between the rituximab-treated group and the standard-dose prednisone group up to month 24.
Danish: De bivirkninger, der opsummeres i tabel 5, forekom alle med en hyppighed ≥ 5% blandt rituximabbehandlede patienter med PV med en ≥ 2% absolut forskel i forekomst mellem den rituximabbehandlede-gruppe og standarddosis prednison-gruppen op til måned 24.
English: Ritemvia monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
Danish: Ritemvia monoterapi er indiceret til behandling af patienter med grad III-IV follikulært lymfom, som er resistente overfor kemoterapi eller som er i deres andet eller efterfølgende relaps efter kemoterapi.
English: In the maintenance therapy clinical trial, 7/57 (12%) patients in the rituximab arm experienced at least one infusion-related reaction.
Danish: I det kliniske studie med vedligeholdelsesbehandling oplevede 7 ud af 57 (12 %) patienter i rituximabarmen mindst én infusionsrelateret reaktion.
English: Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets.
Danish: Mindre hyppigt kan nogle patienter opleve smerte ved infusionsstedet, blærer, hudkløe, kvalme, træthed, hovedpine, vejrtrækningsbesvær, øget blodtryk, hvæsen, ubehag i halsen, hævelse af tunge eller hals, kløende eller løbende næse, opkastning, rødme eller hjertebanken, hjerteanfald eller lavt antal blodplader.
English: MCP, 96 R-MCP,
Danish: OSHO-39 MCP, 96 R-MCP, 105 47
English: In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of rituximab.
Danish: Desuden påvirkede fludarabin og cyclophosphamid tilsyneladende ikke farmakokinetikken af rituximab.
English: During rituximab maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Danish: Under vedligeholdelsesbehandling med rituximab i op til 2 år blev der rapporteret om højere hyppighed end i observationsgruppen af leukopeni (5 % versus 2 %, grad 3/4) og neutropeni (10 % versus 4 %, grad 3/4).
English: Table 16 Percentage of patients who achieved complete remission at 6 months (Intent-to-treat population*)
Danish: Tabel 16 Procentdel af patienter, der opnåede fuldstændig remission ved måned 6 (ITTpopulation*) Rituximab (n = 99)
English: In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p < 0.0001, log-rank test).
Danish: Efter en median observationstid på 48,1 måneder i 1. linje-studiet var medianen for progressionsfri overlevelse 55 måneder i R-FC-gruppen og 33 måneder i FC-gruppen (p < 0,0001, log-rank test).
English: 18-months p = 0.016
Danish: 18-måneder p = 0,016
English: Severe IRRs with fatal outcome have been reported in rheumatoid arthritis patients in the post-marketing setting.
Danish: Alvorlige infusionsrelaterede reaktioner med dødelig udgang er rapporteret hos patienter med reumatoid artrit efter markedsføring.
English: A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicentre, non-inferiority trial.
Danish: I alt 197 patienter i alderen 15 år og derover med svær, aktiv GPA (75 %) eller MPA (24 %) blev inkluderet og behandlet i et randomiseret, dobbeltblindet, placebokontrolleret, non-inferioritetsmulticenterstudie med aktiv kontrolgruppe.
English: The most common infections in the rituximab arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster.
Danish: De mest almindelige infektioner i rituximabarmen inkluderede øvre luftvejsinfektioner, gastroenteritis, urinvejsinfektioner og herpes zoster.
English: Mean change DAS28-ESR ‐1.97** Significance levels were defined as * p<0.05, **p<0.001, ***p<0.0001.
Danish: Signifikante niveauer var defineret som * p< 0,05 **p< 0,001, ***p< 0,0001.
English: Baseline CD19-positive cell counts and size of measurable tumour lesions contributed to some of the variability in CL2 of rituximab in data from 161 patients given 375 mg/m2 as an intravenous infusion for 4 weekly doses.
Danish: Baseline af antallet af CD-19 positive celletal og størrelsen af målte tumorbyrde, forklarer noget af variationen i CL2 af rituximab fra 161 patienter, som fik 375 mg/m2 ugentlig i 4 uger som intravenøs infusion.
English: • an increase in the amount of potassium in the blood
Danish: • forhøjet kalium i blodet
English: Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the rituximab infusion.
Danish: Da hypotension kan forekomme under infusion med rituximab, bør det overvejes at seponere antihypertensiva i 12 timer før rituximab-infusionen.
English: This is because Ritemvia can affect the way some other medicines work.
Danish: Det er vigtigt, da Ritemvia kan påvirke virkningen af anden medicin, og anden medicin kan påvirke virkningen af Ritemvia.
English: Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41%.
Danish: Et Kaplan-Meier estimat af den gennemsnitlige længde af den progressionsfrie overlevelse var 35 måneder for R-CHOP armen sammenlignet med 13 måneder for CHOP armen.
English: The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p=0.0001).
Danish: Den endelige analyse bekræftede, at R-CHOP behandlingen var forbundet med klinisk relevant og statistisk signifikant forbedring af længden af den progressionsfrie overlevelse (de primære effektparametre var død, relaps, forværring af lymfomet eller påbegyndelse af ny antilymfombehandling) (p = 0,0001).
English: The pharmacokinetics of rituximab were assessed following two IV doses of 500 mg and 1000 mg upon re-treatment in the second course.
Danish: Farmakokinetikken for rituximab blev vurderet efter to i.v.-doser på 500 mg og 1.000 mg efter genbehandling i den anden behandlingsserie.
English: Metabolism and nutritional disorders hypercholesterolemia
Danish: Metabolisme og ernæring hyperkolesterolæmi
English: • unusual feelings of the skin - such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch
Danish: • usædvanlig følelse i huden, f.eks. følelsesløshed, prikken, stikken, brænden, myrekryb, nedsat følesans
English: Similarly, in all studies a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12).
Danish: Ligeledes blev et godt til moderat European League Against Rheumatism (EULAR) respons i alle studier opnået af signifikant flere patienter behandlet med rituximab og methotrexat sammenlignet med patienter behandlet med methotrexat alene (tabel 12).
English: A total of 23/99 (23%) rituximab-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Danish: I alt 23/99 (23 %) af de rituximab-behandlede patienter i studiet med induktion af remission blev testet positive for ADA ved måned 18.
English: 48-months p = 0.0096
Danish: 48-måneder p = 0,0096
English: • bald spots on the scalp, chills, headache
Danish: • skaldede pletter i hårbunden, kulderystelser, hovedpine
English: Ritemvia is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Danish: Ritemvia er indiceret til behandling af patienter med moderat til svær pemfigus vulgaris (PV).
English: The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis.
Danish: Rituximabs Fab domæne bindes til CD20 antigenet på B-lymfocytter og Fc domainet kan rekruttere immuneffektor funktioner til at mediere B-celle lysis.
English: Contents of the pack and other information What Ritemvia contains
Danish: Pakningsstørrelse og yderligere oplysninger Ritemvia indeholder:
English: Excipients: This medicinal product contains 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Danish: Hjælpestoffer: Dette lægemiddel indeholder 11,5 mmol (eller 263,2 mg) natrium pr. 50 ml hætteglas.
English: The recommended initial rate for infusion is 50 mg/h; after the first 30 minutes, it can be escalated in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h.
Danish: Efter de første 30 minutter kan den øges med 50 mg/time hvert 30. minut til højst 400 mg/time.
English: Clinical laboratory findings
Danish: Kliniske laboratorieresultater
English: The Physician information about Ritemvia should contain the following key elements:
Danish: Informationen til lægen om Ritemvia skal indeholde følgende nøgle-elementer:
English: Patients randomised to the rituximab group received an initial intravenous infusion of 1000 mg rituximab on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15.
Danish: Patienter, der blev randomiseret til rituximab-gruppen, fik en initial intravenøs infusion på 1.000 mg rituximab på studiedag 1 i kombination med 0,5 mg/kg/dag oral prednison nedtitreret over 3 måneder, hvis de havde moderat sygdom, eller 1 mg/kg/dag oral prednison nedtitreret over 6 måneder, hvis de havde svær sygdom, og fik endnu en intravenøs infusion på 1.000 mg på studiedag 15.
English: Response rate and CR rates analysed using Chi-squared Test. NR: not reached; N/A: not applicable *: only applicable to patients achieving a CR, nPR, PR **: only applicable to patients achieving a CR
Danish: NR: ikke nået; n.a.: ikke relevant *: gælder kun for patienter, som opnåede CR, nPR eller PR **: gælder kun for patienter, som opnåede CR
English: Diarrhoea Dyspepsia Constipation
Danish: Diarré Dyspepsi Obstipation
English: Physicians should exercise caution when considering the use of rituximab in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection, e.g. hypogammaglobulinaemia (see section 4.8).
Danish: Læger bør udvise forsigtighed, når anvendelse af rituximab overvejes til patienter med recidiverende eller kroniske infektioner i anamnesen eller med underliggende sygdomme, som yderligere kan gøre patienterne disponerede for alvorlige infektioner, f.eks. hypogammaglobulinæmi (se pkt.
English: Figure 4: Number of patients who were off or minimal corticosteroid (≤ 10mg/day) therapy over time
Danish: Antallet af patienter uden kortikosteroid-behandling eller behandlet med minimalt kortikosteroid (≤ 10mg/dag) over tid
English: Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of rituximab for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis.
Danish: Dødelig progressiv multifokal leukoencefalopati (PML) er i meget sjældne tilfælde set efter behandling med rituximab for reumatoid artrit og autoimmune sygdomme, inklusive systemisk lupus erythematosus (SLE) og vaskulitis.
English: Clinical experience in rheumatoid arthritis
Danish: Kliniske erfaringer ved reumatoid artrit
English: The most common symptoms were allergic reactions like headache, pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia.
Danish: De mest almindelige symptomer var allergiske reaktioner, såsom hovedpine, pruritus, halsirritation, blussen, udslæt, urticaria, hypertension og pyreksi.
English: This is because Ritemvia can across the placenta and may affect your baby.
Danish: Ritemvia kan overføres til moderkagen og påvirke barnet.
English: Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.
Danish: Rødme, ofte forbundet med blærer, kan forekomme på hud og slimhinder såsom på indersiden af munden, kønsdele eller øjenlåg og kan være ledsaget af feber.
English: In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
Danish: Ved CLL var incidensen af sygdomme fra nervesystemet af grad 3 eller 4 lav både i 1. linje-studiet (4 % R-FC, 4 % FC) og i relaps/refraktær studiet (3 % R-FC, 3 % FC).
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and very rare (< 1/10000).
Danish: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til ≤ 1/100) og meget sjælden (< 1/10.000).
English: The percentage of patients reporting ADRs upon re-treatment with further courses of rituximab was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
Danish: Andelen af patienter, der rapporterede bivirkninger efter genbehandling med flere rituximab serier var sammenlignelig med andelen af patienter, der rapporterede bivirkninger efter induktionsbehandling (alle bivirkninger og bivirkninger af grad 3/4).
English: The majority of patients had received rituximab in combination with chemotherapy or as part of a haematopoietic stem cell transplant.
Danish: De fleste patienter fik rituximab i kombination med med kemoterapi eller som en del af en hæmatopoietisk stamcelletransplantation.
English: You might get infections more easily during your treatment with Ritemvia.
Danish: Risikoen for infektioner kan øges under behandling med Ritemvia.
English: Disease‐free survivala Subgroup analysis PFS
Danish: Varighed til ny lymfombehandling Sygdomsfri overlevelsea Analyse af undergrupper PFS
English: Primary efficacy
Danish: Primært effektmål
English: 53-months p=0.029
Danish: 53-måneder p = 0,029
English: Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied rituximab doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Danish: Baseret på en populationsfarmakokinetisk undersøgelse af 298 patienter med NHL, som fik enkelte eller flere infusioner af rituximab alene eller i kombination med CHOP-kemoterapi (anvendte rituximab-doser varierede fra 100 til 500 mg/m2), vurderedes den non-specifikke clearance (CL1), den specifikke clearance (CL2), hvor B-celler eller tumor sandsynligvis bidrager, og det centrale kompartments distributionsvolumen til (V1) til at være henholdsvis 0,14 l/dag, 0,59 l/dag og 2,7 l. Den estimerede mediane terminale eliminationshalveringstid af rituximab var 22 dage (spændvidde 6, 1-52 dage).
English: Median TTF: years Not reached p < 0.001
Danish: Median TTF: 2,6 år Ikke opnået p < 0,001
English: Exacerbations of pre-existing cardiac conditions such as angina pectoris or congestive heart failure or severe cardiac disorders (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
Danish: Eksacerbationer af hjertelidelser som angina pectoris, kongestiv hjertesygdom eller alvorlige kardielle sygdomme (hjerteinsufficiens, myokardieinfarkt og atrieflimren), lungeødem, multiorgansvigt, tumorlysesyndrom, cytokinfrigivelsessyndrom, nyresvigt og respirationssvigt blev rapporteret med lavere eller ukendt hyppighed.
English: The pharmacokinetics of rituximab were assessed following two intravenous (IV) doses of 500 mg and 1000 mg on Days 1 and 15 in four studies.
Danish: Farmakokinetikken for rituximab blev vurderet efter to i.v.-doser på 500 mg og 1.000 mg på dag 1 og 15 i fire studier.
English: Rituximab was administered on the first day of the treatment cycle.
Danish: Rituximab blev givet på den første dag i en behandlingsserie.
English: R-CVP led to a significant benefit over CVP for the primary endpoint, time to treatment failure (27 months vs. 6.6 months, p < 0.0001, log-rank test).
Danish: R-CVP var signifikant bedre end CVP mht. det primære endepunkt, tid til behandlingssvigt (27 måneder versus 6,6 måneder), p < 0,0001,log rank test).
English: The proportion of CTC Grade 3 events, and of IRRs leading to withdrawal decreased by course and were rare from course 3 onwards.
Danish: CTC og af IRR, som førte til seponering, faldt med antal behandlingsserier og var sjældne fra 3. behandlingsserie og frem.
English: Progression of Kaposi's sarcoma has been observed in rituximab-exposed patients with preexisting Kaposi's sarcoma.
Danish: Der er observeret progression af Kaposis sarkom hos rituximabeksponerede patienter med Kaposis sarkom.
English: Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial.
Danish: Hjælpestoffer: Dette lægemiddel indeholder 2,3 mmol (eller 52,6 mg) natrium pr. 10 ml hætteglas.
English: In rheumatoid arthritis most infusion-related events reported in clinical trials were mild to moderate in severity.
Danish: De fleste infusionsrelaterede hændelser rapporteret i kliniske studier med patienter med reumatoid artrit var lette til moderate i sværhedsgrad.
English: Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Danish: Hætteglas, af klart type I glas med butylgummiprop, indeholdende 500 mg rituximab i 50 ml.
English: Common side effects (may affect up to 1 in 10 people): infections such as herpes infections and eye infection mood disorders such as irritability and depression skin disorders such as itching, hives, and benign lumps feeling tired or dizzy fever headache pain in the tummy pain in the muscles heart beating faster than normal
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter): D. infektioner som f.eks. herpesudbrud og øjeninfektion E. humørsvingninger såsom irritabilitet og depression F. hudsygdomme såsom kløe, nældefeber og godartede knuder G. træthed og svimmelhed
English: Event free survival Response rate (CR, nPR, or PR) CR rates
Danish: Hændelsesfri overlevelse Responsrate (CR, nPR eller PR) CR-rater n.a. n.a.