natgillin/translations-raw huggingface dataset:
Den farmakokinetiske profil af rituximab, når det blev givet som 6 infusioner af 375 mg/m2 i kombination med 6 serier af CHOP kemoterapi, var sammenlignelig med den for rituximab indgivet som monoterapibehandling.
The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
• Symptomer på en infektion
• What the signs of an infection are
• hævede hænder eller ankler
• swelling of the hands or ankles
• irritation i blodkarrene, der kan medføre hudsymptomer
• inflammation of blood vessels including those leading to skin symptoms
I studier, som evaluerede rituximab i kombination med kemoterapi var hyppigheden af arytmier af grad 3 og 4, fortrinsvis supraventrikulære arytmier, som f.eks. takykardi og atrieflagren/atrieflimren, højere i R-CHOP-gruppen (14 patienter, 6,9 %) sammenlignet med CHOP-gruppen (3 patienter, 1,5 %).
In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Studier med rituximab til patienter med tidlig reumatoid artrit (patienter, som ikke tidligere havde været behandlet med methotrexat, og patienter, som havde et utilstrækkeligt respons på methotrexat, men som endnu ikke var behandlet med TNF-alfa hæmmere) har nået deres primære endepunkt.
Studies of rituximab in patients with early arthritis (patients without prior methotrexate treatment and patients with an inadequate response to methotrexate, but not yet treated with TNF-alpha inhibitors) have met their primary endpoints.
Ritemvia er i kombination med glukokortikoider indiceret til behandling af voksne patienter med svær, aktiv granulomatose med polyangiitis (Wegeners granulomatose) (GPA) eller mikroskopisk polyangiitis (MPA).
Ritemvia, 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).
• Øvrige indholdsstoffer: Natriumchlorid, trinatriumcitratdihydrat, polysorbat 80 og vand til injektionsvæsker.
• The other ingredients are sodium chloride, tri-sodium citrate dihydrate, polysorbate 80 and water for injections.
Ved gentagen behandling af patienter med reumatoid artrit med rituximab gennem et år er den samlede erfaring, at andelen af patienter med positive antistoftitere over for S. pneumoniae, influenza, mæslinger, røde hunde, skoldkopper og tetanustoksoid generelt var sammenlignelige til andelen ved baseline.
In the overall experience of rituximab repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
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.
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．
I det kliniske studie med vedligeholdelsesbehandling var hyppigheden af alle grader neutropeni 0 % for rituximab-behandlede patienter vs 5% for azathioprin-behandlede patienter.
In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximab-treated patients vs. 5% for azathioprine treated patients.
Dette svarer til 2,6% af den anbefalede maximale daglige indtagelse af natrium for en voksen.
This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
• Generel følelse af utilpashed eller sløvhed
• Feeling generally unwell or listless.
• tåreflåd, problemer med tårekanaler, irriterede øjne (konjunktivitis)
• producing more tears, tear duct problems, inflamed eye (conjunctivitis)
• infektioner som f.eks. luftvejsinfektioner, urinvejsinfektion (smerter ved vandladning), forkølelse og herpesudbrud
• infections, such as chest infections, urinary tract infections (pain on passing water), colds and herpes infections
I et prospektivt, ublindet, internationalt, multicenter fase III-studie, blev 465 patienter med recidiveret/ refraktært follikulært lymfom i første omgang randomiseret til induktionsbehandling med enten CHOP (cyclophosphamid, doxorubicin, vincristin, prednisolon; n = 231) eller rituximab plus CHOP (R-CHOP, n = 234).
In a prospective, open label, international, multicentre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or rituximab plus CHOP (R-CHOP, n=234).
Hyppigheden defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Information til patienten om Ritemvia skal indeholde følgende nøgle-elementer:
The Patient information about Ritemvia should contain the following key elements:
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.
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.
Yderligere reaktioner, som blev rapporteret i nogle tilfælde, var myokardieinfarkt, atrieflimren, lungeødem og akut reversibel trombocytopeni.
Additional reactions reported in some cases were myocardial infarction, atrial fibrillation, pulmonary oedema and acute reversible thrombocytopenia.
Patienterne fik 2 x 1.000 mg rituximab med to ugers interval, derudover methotrexat (10-25 mg/uge).
Patients received 2 × 1000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Den tilberedte Ritemvia-opløsning skal gives som en intravenøs infusion gennem en separat anlagt intravenøs adgang.
The prepared Ritemvia solution should be administered as an intravenous infusion through a dedicated line.
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.
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.
Den mediane tid indtil progression var 13,0 måneder for responderende patienter.
The projected median time to progression (TTP) for responding patients was 13.0 months.
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.
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.
Undersøgelser nedsat IgMniveauer4
Investigations decreased IgM levels4
Hændelsesfri overlevelse (median)
Overall survival (median)
Øjne forstyrrelse i tåreudskillelsen, konjunctivitis svært synstab5
Eye disorders lacrimation disorder, conjunctivitis severe vision loss5
Alle patienter bør screenes for hepatitis B-virus (HBV) før påbegyndelse af behandling med rituximab.
Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with rituximab.
• feber, hoste, ondt i halsen, brændende smerte ved vandladning eller følelse af svaghed eller almen utilpashed
• fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell
Tabel 5 Bivirkninger opstået hos rituximab-behandlede patienter med pemfigus vulgaris i det kliniske studie op til måned 24 Systemorganklasse
Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24 System Organ Class
Frekvens er baseret på R-FC regime ved relaps/refraktær CLL 2 se også afsnittet om infektioner herunder
1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
Patienter med alvorlige infusionsreaktioner på en biologisk behandling for reumatoid artrit i anamnesen, blev ekskluderet fra deltagelse.
Patients with a history of a serious infusion reaction to a biologic therapy for RA were excluded from entry.
Hos CLL-patienter synes samtidig administration af rituximab ikke at påvirke farmakokinetikken af fludarabin eller cyclophosphamid.
In CLL patients, co-administration with rituximab did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Alvorligt cytokinfrigivelsessyndrom er karakteriseret ved alvorlig dyspnø ofte sammen med bronkospasme og hypoxi, foruden feber, kulderystelser, rigor, urticaria og angioødem.
Severe cytokine release syndrome is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema.
I det kliniske studie med vedligeholdelsesbehandling oplevede 30 ud af 57 (53 %) patienter i rituximab-armen infektioner.
In the maintenance therapy clinical trial, 30/57 (53%) patients in the rituximab arm experienced infections.
Toksisk epidermal nekrolyse (Lyells syndrom) og Stevens-Johnsons syndrom, nogle med dødelig udgang, har været rapporteret meget sjældent.
Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Af de 99 patienter, der blev behandlet med rituximab, oplevede 12 (12%) mindst én infusionsrelateret reaktion.
Of the 99 patients treated with rituximab, 12 (12%) experienced at least one IRR.
Rituximab + Prednison N = 38
Rituximab + Prednisone N=38
Vedligeholdelses- og recidivinfusioner blev ikke administreret senere end 16 uger efter den tidligere infusion.
Maintenance and relapse infusions were administered no sooner than 16 weeks following the previous infusion.
Vaskulære sygdomme hypertension, orthostatisk hypotension, hypotension vasculitis (fortrinsvis kutan), leukocytoklastisk vasculitis
Vascular disorders hypertension, orthostatic hypotension, hypotension vasculitis (predominate ly cutaneous), leukocytoclas tic vasculitis
Samtidig administration med methotrexat påvirkede ikke farmakokinetikken af rituximab hos patienter med reumatoid artrit.
Co-administration with methotrexate had no effect on the pharmacokinetics of rituximab in rheumatoid arthritis patients.
Hvis du er i tvivl, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden du får Ritemvia.
If you are not sure, talk to your doctor, pharmacist or nurse before you are given Ritemvia.
Rituximab er forbundet med infusionsrelaterede reaktioner, som kan være relaterede til frigivelse af cytokiner og/eller andre kemiske mediatorer.
Rituximab is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
De hyppigst observerede bivirkninger hos patienter, som fik rituximab var infusionsrelaterede reaktioner, som forekom hos de fleste patienter under første infusion.
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.
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.
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.
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).
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).
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.
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.
Eftersom hypotension kan forekomme under administration af rituximab, bør det overvejes at afbryde behandling med antihypertensive lægemidler 12 timer før infusion med rituximab.
Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the rituximab infusion.
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.
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.
Dyrestudier har ikke afsløret, at rituximab skulle have skadelig effekt på reproduktionsorganer.
Animal studies did not reveal deleterious effects of rituximab on reproductive organs.
I forhold til sygdomsrisikoen ved baseline blev der observeret en fordel i form af PFS i næsten alle patientundergrupper, som blev analyseret.
The benefit in terms of PFS was observed in almost all patient subgroups analysed according to disease risk at baseline.
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
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
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.
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.
• allergiske reaktioner, som normalt forekommer under infusionen, men kan forekomme i op til
• allergic reactions that are most likely to occur during an infusion, but can occur up to 24
• smerter i led eller ryg
• painful joints or back
Hvis en patient får en overdosis, skal infusionen straks afbrydes, og patienten monitoreres tæt.
Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
• vejrtrækningsstop
• respiratory failure
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.
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.
De farmakokinetiske parametre var sammenlignelige for de to behandlingsserier.
PK parameters for rituximab were comparable over the two treatment courses.
De fleste bivirkninger i rituximab-armen var lette til moderate i intensitet.
Most adverse events in the rituximab arm were mild or moderate in intensity.
• opsvulmet mave.
• swelling of the stomach.
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.
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.
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 %).
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%).
Sådan får du Ritemvia
How to store Ritemvia
Langvarig effekt ved gentagne behandlingsserier
Long-term efficacy with multiple course therapy
Denne infektion kan være dødelig.
This can be fatal.
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.
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.
• almen utilpashed og træthed, rystelser, tegn på influenza
• general discomfort or feeling uneasy or tired, shaking, signs of flu
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
Brug af anden medicin sammen med Ritemvia
Other medicines and Ritemvia
Genbehandling, 1 dosis ugentligt til i alt 4 doser
Re-treatment, weekly for 4 doses
I de fleste tilfælde blev rituximab givet sammen med kemoterapi.
In the majority of these cases, rituximab was administered with chemotherapy.
Indlægsseddel: Information til brugeren Ritemvia 100 mg koncentrat til infusionsvæske, opløsning rituximab Dette lægemiddel er underlagt supplerende overvågning.
Package leaflet: Information for the patient Ritemvia 100 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Den samlede responsrate hos patienter, som tidligere var behandlet med autolog knoglemarvstransplantation var 78 % versus 43 % hos patienter uden autolog knoglemarvstransplantation.
ORR in patients previously treated with autologous bone marrow transplant (ABMT) was 78% versus 43% in patients with no ABMT.
Overfølsomhed over for det aktive stof, murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Sikkerhedsprofilen for rituximab hos patienter med PV var sammenlignelig med den observeret hos patienter med reumatoid artrit og GPA/MPA.
The safety profile of rituximab in patients with PV was consistent with that observed in RA and GPA/MPA patients.
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).
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).
Der var ikke stigning i den samlede hyppighed af infektioner eller alvorlige infektioner efter udvikling af lavt IgG eller IgM (se pkt.
There was no increased rate in overall infections or serious infections after the development of low IgG or IgM (see section 4.4).
• hjerteproblemer, f.eks. hjerteanfald, uregelmæssig eller hurtig hjerteaktion (puls)
• heart problems - such as heart attack, uneven or fast heart rate
Hjælpestoffer: natriumchlorid, trinatriumcitratdihydrat, polysorbat 80, vand til injektionsvæsker.
Excipients: sodium chloride, tri-sodium citrate dihydrate, polysorbate 80, water for injections.
Under kliniske studier har infektioner i de nedre luftveje (inklusive pneumoni) været rapporteret med en forekomst i rituximab-armene svarende til forekomsten i kontrolarmene.
Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab-arms compared to control arms.