FrancophonIA/ELRC3.0 huggingface dataset:
English: Infusion-related adverse reactions of all kinds have been observed in 77% of patients treated with rituximab (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10% of patients) see section 4.8.
Danish: Infusionsrelaterede bivirkninger af enhver art er set hos 77 % af patienterne behandlet med rituximab (herunder cytokinfrigivelsessyndrom ledsaget af hypotension og bronkospasme er set hos 10 % af patienterne) se pkt.
English: Additional reactions reported in some cases were myocardial infarction, atrial fibrillation, pulmonary oedema and acute reversible thrombocytopenia.
Danish: Yderligere reaktioner, som blev rapporteret i nogle tilfælde, var myokardieinfarkt, atrieflimren, lungeødem og akut reversibel trombocytopeni.
English: Patients received 2 × 1000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Danish: Patienterne fik 2 x 1.000 mg rituximab med to ugers interval, derudover methotrexat (10-25 mg/uge).
English: The prepared Ritemvia solution should be administered as an intravenous infusion through a dedicated line.
Danish: Den tilberedte Ritemvia-opløsning skal gives som en intravenøs infusion gennem en separat anlagt intravenøs adgang.
English: The recommended dosage is 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP.
Danish: Den anbefalede dosis er 375 mg/m² legemsoverflade, administreret på dag 1 i hver kemoterapiserie i 8 serier efter intravenøs infusion af glukokortikoid-komponenten i CHOP.
English: The projected median time to progression (TTP) for responding patients was 13.0 months.
Danish: Den mediane tid indtil progression var 13,0 måneder for responderende patienter.
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 follicular lymphoma and chronic lymphocytic leukaemia.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med rituximab i alle undergrupper af den pædiatriske population med follikulært lymfom og CLL (se pkt.
English: Investigations decreased IgM levels4
Danish: Undersøgelser nedsat IgMniveauer4
English: Overall survival (median)
Danish: Hændelsesfri overlevelse (median)
English: Eye disorders lacrimation disorder, conjunctivitis severe vision loss5
Danish: Øjne forstyrrelse i tåreudskillelsen, konjunctivitis svært synstab5
English: Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with rituximab.
Danish: Alle patienter bør screenes for hepatitis B-virus (HBV) før påbegyndelse af behandling med rituximab.
English: • fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell
Danish: • feber, hoste, ondt i halsen, brændende smerte ved vandladning eller følelse af svaghed eller almen utilpashed
English: Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24 System Organ Class
Danish: Tabel 5 Bivirkninger opstået hos rituximab-behandlede patienter med pemfigus vulgaris i det kliniske studie op til måned 24 Systemorganklasse
English: 1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
Danish: Frekvens er baseret på R-FC regime ved relaps/refraktær CLL 2 se også afsnittet om infektioner herunder
English: Patients with a history of a serious infusion reaction to a biologic therapy for RA were excluded from entry.
Danish: Patienter med alvorlige infusionsreaktioner på en biologisk behandling for reumatoid artrit i anamnesen, blev ekskluderet fra deltagelse.
English: In CLL patients, co-administration with rituximab did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Danish: Hos CLL-patienter synes samtidig administration af rituximab ikke at påvirke farmakokinetikken af fludarabin eller cyclophosphamid.
English: Severe cytokine release syndrome is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema.
Danish: Alvorligt cytokinfrigivelsessyndrom er karakteriseret ved alvorlig dyspnø ofte sammen med bronkospasme og hypoxi, foruden feber, kulderystelser, rigor, urticaria og angioødem.
English: In the maintenance therapy clinical trial, 30/57 (53%) patients in the rituximab arm experienced infections.
Danish: I det kliniske studie med vedligeholdelsesbehandling oplevede 30 ud af 57 (53 %) patienter i rituximab-armen infektioner.
English: Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Danish: Toksisk epidermal nekrolyse (Lyells syndrom) og Stevens-Johnsons syndrom, nogle med dødelig udgang, har været rapporteret meget sjældent.
English: Of the 99 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: Rituximab + Prednisone N=38
Danish: Rituximab + Prednison N = 38
English: Maintenance and relapse infusions were administered no sooner than 16 weeks following the previous infusion.
Danish: Vedligeholdelses- og recidivinfusioner blev ikke administreret senere end 16 uger efter den tidligere infusion.
English: Vascular disorders hypertension, orthostatic hypotension, hypotension vasculitis (predominate ly cutaneous), leukocytoclas tic vasculitis
Danish: Vaskulære sygdomme hypertension, orthostatisk hypotension, hypotension vasculitis (fortrinsvis kutan), leukocytoklastisk vasculitis
English: Co-administration with methotrexate had no effect on the pharmacokinetics of rituximab in rheumatoid arthritis patients.
Danish: Samtidig administration med methotrexat påvirkede ikke farmakokinetikken af rituximab hos patienter med reumatoid artrit.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Ritemvia.
Danish: Hvis du er i tvivl, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden du får Ritemvia.
English: Rituximab is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Danish: Rituximab er forbundet med infusionsrelaterede reaktioner, som kan være relaterede til frigivelse af cytokiner og/eller andre kemiske mediatorer.
English: The most frequently observed adverse drug reactions (ADRs) in patients receiving rituximab were IRRs which occurred in the majority of patients during the first infusion.
Danish: De hyppigst observerede bivirkninger hos patienter, som fik rituximab var infusionsrelaterede reaktioner, som forekom hos de fleste patienter under første infusion.
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2 mg/kg/day) for 3-6 months or rituximab (375 mg/m2) once weekly for 4 weeks.
Danish: Patienterne blev randomiseret i forholdet 1:1 til daglig behandling med cyclophosphamid oralt (2 mg/kg/dag) i 3-6 måneder eller rituximab (375 mg/m2) én gang ugentligt i 4 uger.
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Danish: Baseret på den farmakokinetiske populationsanalyse af data fra 97 patienter med GPA eller MPA, der fik 375 mg/m2 rituximab én gang ugentligt i 4 uger, var den estimerede mediane terminale halveringstid 23 dage (9-49 dage).
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs. 0% FC.
Danish: Hos patienter med relaps/refraktær CLL var incidensen af hepatitis B-infektioner af grad 3/4 (reaktivering og primær infektion) 2 % for R-FC regimet versus 0 % for FC regimet.
English: Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the rituximab infusion.
Danish: Eftersom hypotension kan forekomme under administration af rituximab, bør det overvejes at afbryde behandling med antihypertensive lægemidler 12 timer før infusion med rituximab.
English: In a prospective, open label, international, multicentre, phase III trial 1193 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: Animal studies did not reveal deleterious effects of rituximab on reproductive organs.
Danish: Dyrestudier har ikke afsløret, at rituximab skulle have skadelig effekt på reproduktionsorganer.
English: The benefit in terms of PFS was observed in almost all patient subgroups analysed according to disease risk at baseline.
Danish: I forhold til sygdomsrisikoen ved baseline blev der observeret en fordel i form af PFS i næsten alle patientundergrupper, som blev analyseret.
English: Table 1 ADRs reported in clinical trials or during post-marketing surveillance in patients with NHL and CLL disease treated with rituximab monotherapy/maintenance or in combination with chemotherapy
Danish: Tabel 1 Sammenfatning af bivirkninger, som blev rapporteret i kliniske studier eller under post-marketing overvågning, hos patienter med NHL og CLL, som fik rituximab monoterapi eller vedligeholdelsesbehandling med rituximab, eller i kombination med kemoterapi
English: Patients randomised to the standard-dose prednisone group received an initial 1 mg/kg/day oral prednisone tapered off over 12 months if they had moderate disease or 1.5 mg/kg/day oral prednisone tapered off over 18 months if they had severe disease.
Danish: Patienter, der blev randomiseret til standarddosis prednison-gruppen, fik en initial dosis på 1 mg/kg/dag oral prednison nedtitreret over 12 måneder, hvis de havde moderat sygdom, eller 1,5 mg/kg/dag oral prednison nedtitreret over 18 måneder, hvis de havde svær sygdom.
English: • allergic reactions that are most likely to occur during an infusion, but can occur up to 24
Danish: • allergiske reaktioner, som normalt forekommer under infusionen, men kan forekomme i op til
English: • painful joints or back
Danish: • smerter i led eller ryg
English: Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Danish: Hvis en patient får en overdosis, skal infusionen straks afbrydes, og patienten monitoreres tæt.
English: • respiratory failure
Danish: • vejrtrækningsstop
English: The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab-arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
Danish: Følgende reaktioner blev indberettet som bivirkninger under de kliniske studier, men blev rapporteret med samme eller lavere hyppighed i rituximab-armen, sammenlignet med kontrolarmene: hæmatotoksicitet, infektioner hos neutropene patienter, urinvejsinfektioner, sensoriske forstyrrelser og pyreksi.
English: PK parameters for rituximab were comparable over the two treatment courses.
Danish: De farmakokinetiske parametre var sammenlignelige for de to behandlingsserier.
English: Most adverse events in the rituximab arm were mild or moderate in intensity.
Danish: De fleste bivirkninger i rituximab-armen var lette til moderate i intensitet.
English: • swelling of the stomach.
Danish: • opsvulmet mave.
English: In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the rituximab groups.
Danish: I kliniske studier med rituximab som vedligeholdelsesbehandling af recidiveret/ refraktært follikulært lymfom var de mediane IgG-niveauer under nedre referencegrænse (< 7 g/l) i både observationsgruppen og rituximab-gruppen efter induktionsbehandlingen.
English: The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p< 0.0001 Chi-Square test) in the R-CVP group (80.9%) than the CVP group (57.2%).
Danish: Andelen af patienter med tumorrespons (CR, Cru, PR) var signifikant højere (p < 0,0001 chi square test) i R-CVP-gruppen (80,9 %) end i CVP-gruppen (57,2 %).
English: How to store Ritemvia
Danish: Sådan får du Ritemvia
English: Long-term efficacy with multiple course therapy
Danish: Langvarig effekt ved gentagne behandlingsserier
English: This can be fatal.
Danish: Denne infektion kan være dødelig.
English: Significant reductions in disability index (HAQ-DI) and fatigue (FACIT-Fatigue) 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: • general discomfort or feeling uneasy or tired, shaking, signs of flu
Danish: • almen utilpashed og træthed, rystelser, tegn på influenza
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of rituximab 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 rituximab og andre antireumatiske behandlinger, end dem der er specificeret under reumatoid artrit-indikation og dosering, anbefales ikke.
English: Rituximab was administered at a dosage of 375 mg/m2 during the first cycle one day prior to chemotherapy and at a dosage of 500 mg/m2 on day 1 of each subsequent treatment cycle.
Danish: Rituximab blev givet i en dosis på 375 mg/m2 i første serie en dag før kemoterapi og i en dosis på 500 mg/m2 på dag 1 i hver af de efterfølgende behandlingsserier.
English: Significant benefit from maintenance treatment with rituximab was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 7).
Danish: Signifikant fordel af vedligeholdelsesbehandling med rituximab blev også set for de sekundære effektmål; hændelsesfri overlevelse (EFS), tid til næste anti-lymfom-behandling (TNLT), tid til næste kemoterapibehandling (TNCT) og samlet responsrate (ORR) i den primære analyse (tabel 7).
English: Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p< 0.0001 log-rank test).
Danish: Vedligeholdelsesbehandling med rituximab gav en klinisk relevant og statistisk signifikant forbedring af det primære endpoint, PFS (tiden fra vedligeholdelsesrandomiseringen til relaps, sygdomsprogression eller død) sammenlignet med observation alene (p< 0,0001 log rank test).
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to < 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Danish: Hos patienter med granulomatose med polyangiitis eller mikroskopisk polyangiitis faldt antallet af B-celler i perifert blod til < 10 celler/mikroliter efter 2 ugentlige infusioner af rituximab 375 mg/m2 og forblev på dette niveau hos de fleste patienter til måned 6.
English: Other medicines and Ritemvia
Danish: Brug af anden medicin sammen med Ritemvia
English: Re-treatment, weekly for 4 doses
Danish: Genbehandling, 1 dosis ugentligt til i alt 4 doser
English: In the majority of these cases, rituximab was administered with chemotherapy.
Danish: I de fleste tilfælde blev rituximab givet sammen med kemoterapi.
English: Package leaflet: Information for the patient Ritemvia 100 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Ritemvia 100 mg koncentrat til infusionsvæske, opløsning rituximab Dette lægemiddel er underlagt supplerende overvågning.
English: ORR in patients previously treated with autologous bone marrow transplant (ABMT) was 78% versus 43% in patients with no ABMT.
Danish: Den samlede responsrate hos patienter, som tidligere var behandlet med autolog knoglemarvstransplantation var 78 % versus 43 % hos patienter uden autolog knoglemarvstransplantation.
English: Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
English: The safety profile of rituximab in patients with PV was consistent with that observed in RA and GPA/MPA patients.
Danish: Sikkerhedsprofilen for rituximab hos patienter med PV var sammenlignelig med den observeret hos patienter med reumatoid artrit og GPA/MPA.
English: Following two intravenous infusions of rituximab at a dose of 1000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 L (range, 1.7 to 7.51 L).
Danish: Efter to intravenøse infusioner af rituximab i en dosis på 1.000 mg med to ugers interval, var den gennemsnitlige halveringstid 20,8 dage (i intervallet 8,58 dage til 35,9 dage), den gennemsnitlige systemiske clearance var 0,23 l/dag (i intervallet 0,091 til 0,67 l/dag) og det gennemsnitlige steadystate fordelingsvolumen var 4,6 l (i intervallet 1,7 til 7,51 l).
English: There was no increased rate in overall infections or serious infections after the development of low IgG or IgM (see section 4.4).
Danish: Der var ikke stigning i den samlede hyppighed af infektioner eller alvorlige infektioner efter udvikling af lavt IgG eller IgM (se pkt.
English: • heart problems - such as heart attack, uneven or fast heart rate
Danish: • hjerteproblemer, f.eks. hjerteanfald, uregelmæssig eller hurtig hjerteaktion (puls)
English: Excipients: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections.
Danish: Hjælpestoffer: natriumchlorid, trinatriumcitratdihydrat, polysorbat 80, vand til injektionsvæsker.
English: Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab-arms compared to control arms.
Danish: Under kliniske studier har infektioner i de nedre luftveje (inklusive pneumoni) været rapporteret med en forekomst i rituximab-armene svarende til forekomsten i kontrolarmene.
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 1x109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1x109/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 1x109/l mellem dag 24 og 42 efter sidste dosis) eller indtraf sent (defineret som neutrofiltal under 1x109/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: During the treatment course in studies with rituximab in combination with chemotherapy, grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Danish: I studier blev der under behandlingsforløbet sædvanligvis rapporteret hyppigere om leukopeni grad 3/4 (R-CHOP 88 % versus CHOP 79 %, R-FC 23 % versus FC 12 %), neutropeni (R-CVP 24 % versus CVP 14 %; R-CHOP 97 % versus CHOP 88 %, R-FC 30 % versus FC 19 % ved tidligere ubehandlet CLL), pancytopeni (R-FC 3 % versus FC 1 % ved tidligere ubehandlet CLL) ved rituximab i kombination med kemoterapi end ved kemoterapi alene.
English: Initial treatment, weekly for 4 doses
Danish: Induktionsbehandling, 1 dosis ugentligt til i alt 4 doser
English: p‐value
Danish: p-værdi
English: Package leaflet: Information for the patient Ritemvia 500 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Ritemvia 500 mg koncentrat til infusionsvæske, opløsning rituximab Dette lægemiddel er underlagt supplerende overvågning.
English: The most common infections in the rituximab group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Danish: De mest almindelige infektioner i rituximab-gruppen var herpes simplex og zoster infektioner, bronkitis, urinvejsinfektion, svampeinfektion og konjunktivitis.
English: If you are being treated for pemphigus vulgaris
Danish: c) Hvis du behandles for pemfigus vulgaris
English: Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Danish: Populationer med reumatoid artrit, som ikke tidligere har været behandlet med methotrexat (MTX) Anvendelse af rituximab hos patienter, som ikke tidligere har været behandlet med MTX, anbefales ikke, da et favorabelt risk/benefit-forhold ikke er blevet fastlagt.
English: Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001 MCID HAQ-DI ≥0.22, MCID SF-36 PHS >5.42, MCID SF-36 MHS >6.33
Danish: Gennemsnitsændring i SF-36 PHS % SF-36 PHS MCID Gennemsnitsændring i SF-36 MHS % SF-36 MHS MCID † Resultat ved uge 24 Signifikant forskel fra placebo ved det primære tidspunkt: * p < 0,05, **p < 0,001 ***p ≤ 0,0001 MCID HAQDI ≥ 0,22, MCID SF-36 PHS > 5,42, MCID SF-36 MHS > 6,33
English: 3 patients (8%) in the rituximab group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Danish: 3 patienter (8 %) i rituximab-gruppen oplevede et samlet antal på 5 alvorlige infektioner (Pneumocystis jiroveci-pneumoni, infektiøs trombose, intervertebral diskitis, lungeinfektion, Staphylococcal-sepsis) og 1 patient (3 %) i standarddosis prednison-gruppen oplevede 1 alvorlig infektion (Pneumocystis jiroveci-pneumoni).