FrancophonIA/ELRC3.0 huggingface dataset:
English: The HCP educational leaflet about Rixathon for non-oncology indications contains the following key elements: - The need for close supervision during administration in an environment where full resuscitation facilities are immediately available - The need to check, prior to Rixathon treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system, and recent history of, or planned, vaccination, and a history of infusion-related reaction - The need to monitor patients for infections, especially PML, during and after Rixathon treatment - Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML - 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: Undervisningsbrochuren til sundhedspersonalet om Rixathon mod ikke-onkologiske indikationer indeholder følgende nøgle-elementer: - Nødvendigheden af tæt overvågning under administration i omgivelser, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt - Nødvendigheden af at kontrollere for infektioner, for immunsuppression, for tidligere/nuværende medicinering, der påvirker immunsystemet, og for nylige og/eller planlagte vaccinationer samt tidligere infusionsrelaterede reaktioner før behandling med Rixathon påbegyndes - Nødvendigheden af at overvåge patienterne for infektioner, især PML, under og efter behandling med Rixathon - Detaljeret information om risikoen for PML, nødvendigheden af at diagnosticere PML i tide og egnede metoder til at diagnosticere PML - 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 - Nødvendigheden af at udlevere patientkortet ved hver infusion
English: FU: follow-up; NR: not reached at time of clinical cut off, TNCT: time to next chemotherapy treatment; TNLT: time to next anti lymphoma treatment.
Danish: KI: konfidensinterval; TNLT: Tid til næste anti-lymfom-behandling; TNCT: Tid til næste kemoterapibehandling; NR: Ikke opnået ved det kliniske skæringstidspunkt.
English: • The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections (see section 2).
Danish: • Øvrige indholdsstoffer: Natriumcitrat, polysorbat 80, natriumchlorid, natriumhydroxid, saltsyre og vand til injektionsvæsker (se punkt 2).
English: NR: not reached; a: only applicable to patients achieving a CR
Danish: NR NR: ikke opnået; a: kun gældende for patienter, der opnåede fuldstændigt respons
English: The Patient educational leaflet about Rixathon contains the following key elements: - Detailed information on the risk of infections and PML - Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any - The importance of sharing this information with their partner or caregiver - Information on the Patient Alert Card
Danish: Undervisningsbrochuren til patienten om Rixathon indeholder følgende nøgle-elementer: - Detaljeret information om risikoen for infektioner og PML - Information om symptomer på infektioner, især PML, og nødvendigheden af at kontakte deres læge straks, hvis de får nogle symptomer - Vigtigheden af at dele denne information med deres evt. partner eller omsorgsperson - Informationen på patientkortet
English: In case of such an event, with a suspected relationship to rituximab, treatment should be permanently discontinued.
Danish: Hvis en sådan bivirkning skulle opstå med formodet relation til rituximab, skal behandlingen seponeres permanent.
English: Contents of the pack and other information What Rixathon contains
Danish: Pakningsstørrelser og yderligere oplysninger Rixathon indeholder:
English: Rixathon 100 mg concentrate for solution for infusion EU/1/17/1185/001
Danish: Rixathon 100 mg koncentrat til infusionsvæske, opløsning EU/1/17/1185/001
English: Rituximab mean clearance and volume of distribution were 0.313 L/day (range, 0.116 - 0.726 L/day) and 4.50 L (range 2.25 - 7.39 L) respectively.
Danish: Gennemsnitlig clearance og fordelingsvolumen for rituximab var henholdsvis 0,313 l/dag (0,116-0,726 l/dag) og 4,50 l (2,25-7,39 l).
English: Subsequent doses of Rixathon 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 Rixathon-doser kan infunderes med 100 mg/time initialt og øges med 100 mg/time hvert 30. minut til højst 400 mg/time.
English: Placebo+MTX Rituximab+MTX 2 x 1,000 mg
Danish: Placebo+MTX Rituximab+MTX 2 × 1.000 mg
English: The Patient Alert Card for Rixathon contains the following key elements: - The need to carry the card at all times and to show the card to all treating health care professionals - Warning on the risk of infections and PML, including the symptoms - The need for patients to contact their health care professional if symptoms occur
Danish: Patientkortet for Rixathon indeholder følgende nøgle-elementer: - Nødvendigheden af altid at have kortet på sig og at vise kortet til alt behandlende sundhedspersonale - Advarsel om risikoen for infektioner og PML, inklusive alle symptomer - Nødvendigheden af, at patienterne kontakter deres læge, hvis de får symptomer
English: Chemical and physical stability of Rixathon diluted in 5% glucose solution has been demonstrated for 24 hours at 2°C - 8°C and subsequently 12 hours at room temperature (≤25°C).
Danish: Kemisk og fysisk stabilitet af Rixathon, der er fortyndet i 5 % glukoseopløsning, er blevet påvist i 24 timer ved 2 °C - 8 °C og efterfølgende 12 timer ved stuetemperatur (≤25 °C).
English: • If you are having Rixathon with chemotherapy
Danish: • Hvis du får Rixathon sammen med kemoterapi
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: A total of 117 patients (88 with GPA, 24 with MPA, and 5 with renal-limited ANCA-associated vasculitis) in disease remission were randomized 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: In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1,000 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: B lymphocytes are involved in the cause of some of the symptoms you have.
Danish: Blymfocytter er medvirkende til nogle af de symptomer, du har.
English: In a prospective, open label, international, multi-centre, phase III trial 1,193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
Danish: I et prospektivt, ublindet, internationalt, multicenter fase III-studie fik 1.193 patienter med tidligere ubehandlet, fremskredent follikulært lymfom induktionsbehandling med R-CHOP (n=881), R-CVP (n=268) eller R-FCM (n=44) efter investigators valg.
English: Significant reductions in disability index (HAQ-DI) and fatigue (FACIT-Fatigue) scores were observed in patients treated with rituximab compared to patients treated with methotrexate alone.
Danish: Signifikant reduktion i funktionsindeks (HAQ-DI) og træthedsscore (FACIT-Fatigue) blev observeret hos patienter, der blev behandlet med rituximab, sammenlignet med patienter behandlet med methotrexat alene.
English: Rixathon 500 mg concentrate for solution for infusion EU/1/17/1185/003
Danish: Rixathon 500 mg koncentrat til infusionsvæske, opløsning EU/1/17/1185/003
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time)
Danish: Tabel 8 Induktionsfase: Oversigt over effektdata for CHOP versus R-CHOP (31 måneders median observationstid)
English: Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1 x 109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1 x 109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with rituximab plus FC.
Danish: Studier af tidligere ubehandlet og relaps/refraktær CLL har fastslået, at hos op til 25 % af patienterne behandlet med R-FC var neutropeni forlænget (defineret som neutrofiltal, der forblev under 1 x 109/l mellem dag 24 og 42 efter sidste dosis) eller indtraf sent (defineret som neutrofiltal under 1 x 109/l senere end dag 42 efter sidste dosis hos patienter uden tidligere forlænget neutropeni eller hos patienter, som restituerede før dag 42) efter behandling med rituximab plus FC.
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group.
Danish: Forskellen i den samlede overlevelse viste en stærk klinisk forskel (p=0,029, log rank test stratificeret ved center): overlevelsesrater på 53 måneder var 80,9 % for patienter i R-CVP-gruppen i forhold til 71,1 % for patienter i CVP-gruppen.
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 rituximab-behandlede patienter med PV med en ≥ 2 % absolut forskel i forekomst mellem den rituximab-behandlede gruppe og standarddosis prednison-gruppen op til måned 24.
English: • Anxiety, depression
Danish: • angst, depression
English: In the induction of remission clinical trial, at 6 months, in the rituximab group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline, had low IgA, IgG and IgM levels, respectively compared to 25%, 50% and 46% in the cyclophosphamide group.
Danish: I det kliniske studie med induktion af remission havde henholdsvis 27 %, 58 % og 51 % af patienterne i rituximab-gruppen med normale immunglobulin-niveauer ved baseline lave IgA-, IgG- og IgMniveauer ved måned 6 sammenlignet med henholdsvis 25 %, 50 % og 46 % i cyclophosphamidgruppen.
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with Rixathon.
Danish: Det anbefales, at immunglobulinniveauer måles før initiering af Rixathon-behandling.
English: Chemical and physical stability of Rixathon diluted in 0.9% sodium chloride solution has been demonstrated for 30 days at 2°C - 8°C and subsequently 24 hours at room temperature (≤25°C).
Danish: Kemisk og fysisk stabilitet af Rixathon, der er fortyndet i 0,9 % natriumchloridopløsning, er blevet påvist i 30 dage ved 2 °C - 8 °C og efterfølgende 24 timer ved stuetemperatur (≤25 °C).
English: Rixathon is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Danish: Rixathon er indiceret til behandling af tidligere ubehandlede patienter med stadium III-IV follikulært lymfom i kombination med kemoterapi.
English: Aseptically withdraw the necessary amount of Rixathon, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Danish: Under anvendelse af aseptiske procedurer trækkes den nødvendige mængde Rixathon op og fortyndes til en beregnet koncentration på 1 til 4 mg/ml rituximab i en infusionspose, der indeholder steril, pyrogenfri natriumchloridopløsning til injektion 9 mg/ml (0,9 %) eller 5 % D-glukose i vand.
English: Of the ninety nine patients treated with rituximab, 12 (12%) experienced at least one IRR.
Danish: Af de 99 patienter, der blev behandlet med rituximab, oplevede 12 (12 %) mindst én infusionsrelateret reaktion.
English: Lung infiltration
Danish: lungeinfiltrater
English: Placebo+MTX Rituximab+MTX (2 x 1,000 mg)
Danish: Placebo+MTX Rituximab+MTX (2 × 1.000 mg)
English: Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24
Danish: Tabel 5 Bivirkninger opstået hos rituximab-behandlede patienter med pemfigus vulgaris i det kliniske studie op til måned 24
English: A total of 19/34 (56%) patients with PV, who were treated with rituximab, tested positive for ADA antibodies by 18 months.
Danish: I alt 19 ud af 34 (56 %) patienter med PV, som blev behandlet med rituximab, blev testet positive for ADA antistoffer ved måned 18.
English: 4 Includes observations collected as part of routine laboratory monitoring.
Danish: 4 Herunder observationer, som var indsamlet som en del af rutinemæssig laboratorie-overvågning 5 Inklusive dødelige tilfælde
English: Rixathon should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Danish: Rixathon bør ikke administreres til patienter med en aktiv, alvorlig infektion (for eksempel tuberkulose, sepsis og opportunistiske infektioner, se pkt.
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: The number of rituximab plus low-dose prednisone patients off prednisone therapy or on minimal therapy (prednisone dose of 10 mg or less per day) compared to standard-dose prednisone patients over the 24-month treatment period shows a steroid-sparing effect of rituximab (Figure 4).
Danish: Antallet af patienter behandlet med rituximab plus lavdosis prednison uden prednison-behandling eller behandlet minimalt (prednison dosis på 10 mg eller mindre pr. dag) viser en steroidbesparende virkning af rituximab sammenlignet med patienter behandlet med standarddosis prednison over behandlingsperioden på 24 måneder (figur 4).
English: In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
Danish: I relaps/refraktær-studiet var medianen for progressionsfri overlevelse (det primære endepunkt) 30,6 måneder i R-FC-gruppen og 20,6 måneder i FC-gruppen (p=0,0002, log-rank test).
English: CR2) PR2)
Danish: PR2)
English: Rituximab may make you feel dizzy and may affect your ability to drive or use any tools or machines.
Danish: Rituximab kan føre til svimmelhed og kan påvirke din evne til at køre motorkøretøj eller arbejde med maskiner.
English: Similarly, 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: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.
Danish: Der er kun begrænsede effekt-og sikkerhedsdata tilgængelige for patienter, som tidligere er behandlet med monoklonale antistoffer inklusive rituximab, og for patienter, som er refraktære over for tidligere behandling med rituximab og kemoterapi.
English: Overall response rate* chi-squared test p value odds ratio (95% CI) Complete response (CR/CRu) 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: Table 10b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT)48.1 months median observation time
Danish: Tabel 10b Førstelinjebehandling af kronisk lymfatisk leukæmi Hazard ratioer for progressionsfri overlevelse efter Binet stadium (ITT) - median observationstid: 48,1 måneder
English: • Pain on passing water (urinary tract infection)
Danish: • smerte ved vandladning (urinvejsinfektion)
English: The efficacy and safety of rituximab in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicenter trial (Trial 1).
Danish: Effekt og sikkerhed af rituximab til lindring af symptomer og kliniske fund ved reumatoid artrit hos patienter med et utilstrækkelig respons på TNF-hæmmere blev vist i et pivotalt, randomiseret, kontrolleret, dobbeltblindet, multicenterstudie (studie 1).
English: Safety and efficacy of rituximab have not been established in combination with other chemotherapies in diffuse large B cell non- Hodgkin's lymphoma.
Danish: Sikkerhed og effekt af rituximab er ikke påvist i kombination med andre kemoterapiregimer til behandling af diffust storcellet B-celle non-Hodgkin-lymfom.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and very rare (< 1/10,000).
Danish: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til ≤ 1/100) og meget sjælden (< 1/10.000).
English: In the clinical trial on induction of remission, which included 99 rituximab-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
Danish: I det kliniske studie med induktion af remission, som inkluderede 99 rituximab-behandlede patienter var den samlede infektionshyppighed ca. 237 pr. 100 patientår (95 % konfidensinterval 197-285) ved det primære endepunkt ved måned 6.
English: This is because Rixathon can cross the placenta and may affect your baby.
Danish: Rixathon kan passere moderkagen og påvirke barnet.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen, apotekspersonalet eller sundhedspersonalet om al medicin, du tager i øjeblikket, har taget for nyligt eller planlægger at tage.
English: You will always be given Rixathon as a drip (intra-venous infusion).
Danish: Rixathon gives altid i et drop (intravenøs infusion).
English: In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58% vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
Danish: I en subgruppeanalyse var den samlede responsrate højere hos patienter med histologisk subtype IWF B, C og D sammenlignet med subtype IWF A (58 % versus 12 %), højere hos patienter hvis største læsions længste diameter var < 5 cm versus > 7 cm (53 % versus 38 %) og højere hos patienter med kemoterapifølsomt relaps sammenlignet med kemoterapiresistent relaps (defineret som en responsvarighed < 3 måneder) (50 % versus 22 %).
English: The overall safety profile of rituximab in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia is based on data from patients from clinical trials and from post-marketing surveillance.
Danish: Rituximabs sikkerhedsprofil ved non-Hodgkin-lymfom og CLL er baseret på data fra patienter fra kliniske studier og fra post-marketing overvågning.
English: Granulomatosis with polyangiitis and microscopic polyangiitis Rixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Danish: Granulomatose med polyangiitis og mikroskopisk polyangiitis Rixathon er i kombination med glukokortikoider indiceret til behandling af voksne patienter med svær, aktiv granulomatose med polyangiitis (Wegeners granulomatose) (GPA) eller mikroskopisk polyangiitis (MPA).
English: Rituximab binding to CD 20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.
Danish: Rituximabs binding til CD 20 antigenet på B-lymfocytter har vist også at inducere celledød via apoptose.
English: Medicines given before each Rixathon administration
Danish: Medicin, der gives inden hver behandling med Rixathon
English: Table 17 Complete remission at 6-months by disease status Rituximab Cyclophosphamide Difference (CI 95%)
Danish: Tabel 17 Fuldstændig remission ved måned 6 opgjort efter sygdomsstatus Rituximab Cyclophosphamid
English: Rixathon maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Danish: Rixathon vedligeholdelsesbehandling er indiceret til behandling af follikulært lymfom hos patienter, der responderer på induktionsbehandling.
English: The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test).
Danish: Den mediane responsvarighed var 37,7 måneder i R-CVP-gruppen, og den var 13,5 måneder i CVPgruppen (p < 0,0001), log rank test).
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of Rixathon and anti-rheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Danish: Samtidig/fortløbende anvendelse af andre DMARDs hos patienter med reumatoid artrit Samtidig anvendelse af Rixathon og andre antireumatiske behandlinger, end dem der er specificeret under reumatoid artrit-indikation og dosering, anbefales ikke.
English: The final analysis confirmed that R-CHOP 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: Therefore patients with a history of cardiac disease and/or cardiotoxic chemotherapy should be monitored closely.
Danish: Derfor bør patienter med hjertelidelse og/eller tidligere kardiotoksisk kemoterapi i anamnesen monitoreres nøje.