FrancophonIA/ELRC3.0 huggingface dataset:
English: • The need to monitor patients for infections, especially PML, during and after
Danish: • Nødvendigheden af at overvåge patienterne for infektioner, især PML, under og efter
English: Rituzena may be used for the treatment of several different conditions in adults.
Danish: Rituzena kan anvendes til behandling af flere forskellige tilstande hos voksne.
English: See the Rituzena package leaflet for more information.
Danish: Se indlægssedlen i Rituzena-pakken for mere information.
English: However, the possible risk for the development of solid tumours cannot be excluded at this time.
Danish: En potentiel risiko for udvikling af solide tumorer kan dog ikke
English: The risk of disease progression was reduced by 46 % and the risk of relapse by
Danish: Risikoen for sygdomsprogression blev reduceret med 46 % og risikoen for relaps med 51 %.
English: The safety and efficacy of Rituzena in children below 18 years has not been established.
Danish: Rituzenas sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Currently, there are limited data on possible medicinal product interactions with rituximab.
Danish: På nuværende tidspunkt er der begrænsede data om mulige lægemiddelinteraktioner med rituximab.
English: There was no cumulative toxicity in terms of infections reported over a 2 year treatment period.
Danish: Der blev ikke rapporteret om kumulativ toksicitet med hensyn til infektioner i en behandlingsperiode på 2 år.
English: When sticking to the surface of this cell, rituximab causes the cell to die.
Danish: Når det bindes til overfladen af denne celle, får rituximab cellen til at dø.
English: None of the 99 rituximab-treated patients were HACA positive at screening.
Danish: Ingen af de 99 rituximab-behandlede patienter var HACA-positive ved screening.
English: Do not have Rituzena if any of the above apply to you.
Danish: Du må ikke få Rituzena, hvis ét eller flere af ovenstående punkter gælder for dig.
English: Rituzena is indicated in adults for the following indications:
Danish: Rituzena er indiceret hos voksne til følgende indikationer:
English: Some vaccines should not be given at the same time as Rituzena or in the months after you receive Rituzena.
Danish: Nogle vaccinationer bør ikke gives på samme tid som Rituzena eller i månederne efter du har fået Rituzena.
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6)
Danish: • du er allergisk over for rituximab, andre proteiner, der ligner rituximab eller et af de øvrige indholdsstoffer i Rituzena (angivet i punkt 6).
English: The prepared infusion solution of rituximab is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
Danish: Den tilberedte rituximab infusionsopløsning er fysisk og kemisk stabil i 24 timer ved 2 °C - 8 °C og efterfølgende 12 timer ved stuetemperatur (ikke over 30 °C).
English: Your doctor will check if you should have any vaccines
Danish: Din læge vil undersøge, om du bør vaccineres inden du
English: During or within the first 2 hours of the first infusion you may develop fever, chills and shivering.
Danish: Under eller inden for de første 2 timer af den første infusion kan du få feber, kuldegysninger og rysten.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
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
English: Rituzena will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Danish: Du får Rituzena af en læge eller sygeplejerske med erfaring i denne behandling.
English: If you have heart disease or angina, these infusion reactions might get worse.
Danish: Hvis du har hjerteproblemer eller angina pectoris kan disse infusionsreaktioner forværres.
English: Occurred at various times up to several months after completion of rituximab
Danish: Forekom på forskellige tidspunkter op til flere måneder efter afslutningen af behandlingen med rituximab
English: Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing
Danish: Der blev observeret effekt både hos nyligt diagnosticerede patienter og hos patienter med
English: The clinical relevance of HACA formation in rituximab-treated patients is unclear.
Danish: Den kliniske relevans af HACA-dannelse hos rituximab-behandlede patienter er uklar.
English: The spread of these abnormal B-lymphocytes is the cause of symptoms you may have.
Danish: Det er spredningen af disse unormale B-lymfocytter, der er årsagen til de symptomer, du kan have.
English: You should also tell them about your Rituzena treatment.
Danish: Du skal også fortælle dem om din Rituzena-behandling.
English: A total of 23/99 (23%) rituximab-treated patients in the trial tested positive for HACA by 18 months.
Danish: I alt 23/99 (23 %) af de rituximab-behandlede patienter i studiet blev testet positive for HACA ved måned 18.
English: In most cases, the infusion can be resumed at a 50 % reduction in rate (e.g. from 100 mg/h to 50 mg/h) when symptoms have completely
Danish: I de fleste tilfælde kan infusionen genoptages med en 50 % reduktion i hastigheden (f.eks. fra 100 mg/time til 50 mg/time), når symptomerne er fuldstændigt forsvundet.
English: Rituzena should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see
Danish: Rituzena skal anvendes under tæt supervision af erfarent sundhedspersonale i omgivelser, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt (se pkt.
English: The antigen is expressed on >95 % of
Danish: Antigenet udtrykkes på > 95 % af alle B-celle non
English: Before you are given Rituzena, you will be given other medicines (pre-medication) to prevent or
Danish: Inden du får Rituzena, vil du få anden medicin (præmedicin), der forebygger eller mindsker mulige
English: Also please tell your doctor if you have had a lot of infections in the past or
Danish: Fortæl også lægen, hvis du tidligere har haft mange infektioner eller lider af alvorlige infektioner
English: Initial treatment, weekly for 4 doses
Danish: Genbehandling, 1 dosis ugentligt til i alt 4 doser
English: Very common side effects (may affect more than 1 in 10 people): • infections, such as chest infections, urinary tract infections (pain on passing water), colds
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter): • infektioner som f.eks. luftvejsinfektioner, urinvejsinfektion (smerter ved vandladning),
English: The proportions of patients experiencing cardiac reactions (all or serious) did not increase over multiple courses.
Danish: Andelen af patienter, som oplevede kardielle bivirkninger (alle eller alvorlige), steg ikke
English: Rituzena may also cause changes in laboratory tests carried out by your doctor.
Danish: Rituzena kan også ændre resultaterne af de blodprøver, som lægen har bestilt.
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 <
Danish: Den mediane responsvarighed var 37,7 måneder i R-CVP-gruppen, og den var 13,5 måneder i CVP-gruppen
English: The proportion of patients with IgG levels below the LLN was about 60% in the rituximab group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2
Danish: Andelen af patienter med IgG-niveauer under den nedre referenceramme var ca. 60 % i rituximab gruppen i hele behandlingsperioden på 2 år, hvorimod den faldt i observationsgruppen (36 % efter 2 år).
English: Table 7 Percentage of patients who achieved complete remission at 6 months Cyclophosphamide (n = 98)
Danish: Tabel 7 Procentdel af patienter, der opnåede fuldstændig remission ved måned 6 (ITTCyclophosphamid (n = 98)
English: A slight but not significant improvement in overall survival was reported in the R-FC
Danish: En lille men ikke signifikant forbedring for den samlede overlevelse blev rapporteret i R-FC-armen i forhold til FC-armen.
English: The incidence of thrombocytopenia was low (<1% , grade 3/4) and was not different between treatment arms.
Danish: Hyppigheden af trombocytopeni var lav (< 1 , grad 3/4), og der var ingen forskel mellem behandlingsarmene.
English: Tell your doctor immediately if you get signs of an infection including:
Danish: Kontakt straks lægen, hvis du får tegn på infektion, f.eks.:
English: The majority of patients (81%) showed signs of B cell return, with counts >10 cells/μL by month 12, increasing to 87% of patients by month 18.
Danish: Størstedelen af patienterne (81 %) viste tegn på B-celleregenerering med > 10 celler/mikroliter ved måned 12; dette steg til 87 % af patienterne ved måned 18.
English: Summary of the safety profile (rheumatoid arthritis)
Danish: Resumé af sikkerhedsprofilen (reumatoid artrit)
English: In contrast, three patients (1.5 %) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Danish: Derimod fik tre patienter (1,5 %) cerebrovaskulære hændelser i CHOP-armen, og alle forekom i follow-up-perioden.
English: Patients with a high tumour burden or with a high number (≥25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should only be treated with extreme caution.
Danish: Patienter med stor tumorbyrde eller med et højt antal (≥ 25 x 109/l) cirkulerende maligne celler, som f.eks. patienter med CLL, som kan have øget risiko for især svært cytokinfrigivelsessyndrom, bør kun behandles med yderste forsigtighed.
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials 2 Frequency category derived from post-marketing data.
Danish: 1 Hyppigheden stammer fra laboratorie-værdier, som var indsamlet som en del af rutinemæssig laboratorie-overvågning i 2 Hyppigheden stammer fra data efter markedsføring
English: • low number of white blood cells sometimes with fever, or low number of blood cells called
Danish: • lavt antal hvide blodlegemer, nogle gange med feber eller lavt antal blodplader
English: When you are treated with Rituzena in combination with chemotherapy, you will receive Rituzena every 28 days until you have received 6 doses.
Danish: Hvis du behandles med Rituzena i kombination med kemoterapi, vil du få Rituzena hver 28. dag, indtil du har fået 6 doser.
English: Ninety nine patients were treated with rituximab and 12% experienced at least one IRR.
Danish: 99 patienter blev behandlet med rituximab, og 12 % oplevede mindst én infusionsrelateret reaktion.
English: When remission with rituximab has been achieved, continued immunosuppressive therapy may be considered to prevent relapse.
Danish: Når remission med rituximab er opnået, kan fortsat immunsuppressiv behandling overvejes for at forhindre relaps.
English: This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need)
Danish: Dette bør efterfølges af prednison oralt, 1 mg/kg/dag (dog højst 80 mg/dag og nedtitreret så hurtigt som muligt afhængigt af det kliniske behov) under og efter behandling med
English: The cells that are affected by Rituzena help to fight infection and you should wait until the infection has passed before you are given Rituzena.
Danish: Cellerne, der påvirkes af Rituzena hjælper med at bekæmpe infektioner, og du bør vente med behandling med Rituzena, indtil infektionen er forsvundet.
English: If a patient develops PML the dosing of rituximab must be permanently discontinued.
Danish: Hvis en patient udvikler PML, skal behandlingen med rituximab seponeres permanent.
English: These are listed below under “Other side effects”.
Danish: Disse er angivet under ”Andre
English: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to rituximab therapy.
Danish: Vaccination Lægen bør gennemgå patientens vaccinationsstatus og følge gældende vaccinationsvejledninger inden igangsætning af rituximab behandling.
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Danish: Patientkortet indeholder vigtige oplysninger om sikkerhed for patienterne angående potentiel øget risiko for infektioner,
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: Frekvenserne er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til ≤ 1/100) og meget sjælden (< 1/10.000).
English: Rituzena contains the active substance “rituximab”.
Danish: Rituzena indeholder det aktive indholdsstof rituximab.
English: Cases of interstitial lung disease, some with fatal outcome, have been reported.
Danish: Tilfælde af interstitiel lungesygdom, hvoraf nogle med dødelig udgang, er blevet rapporteret.
English: Rituzena in combination with chemotherapy destroys these cells.
Danish: Rituzena anvendt sammen med kemoterapi ødelægger disse celler.
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Rituzena Alert Card for patients with non-oncology diseases
Danish: TEKST TIL PATIENTKORT FOR IKKE-ONKOLOGISKE INDIKATIONER Rituzena-patientkort for ikke-onkologiske indikationer
English: When Rituzena is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Danish: Når Rituzena gives i kombination med kemoterapi, bør standard dosisreduktioner for de kemoterapeutiske lægemidler anvendes.
English: 95.1%b CI (−3.2%, 24.3%) a a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
Danish: (−3,2 %; 24,3 %) a a Der blev vist non-inferioritet, idet den nedre grænse (−3,2 %) var højere end den forud fastsatte nonb Konfidensintervallet på 95,1 % afspejler et yderligere 0,001 alfa for at tage højde for en interimseffektanalyse
English: Continued immunosuppressive therapy may be especially appropriate in patients at risk for relapses (i.e. with history of earlier relapses and granulomatosis with polyangiitis, or patients with reconstitution of B-lymphocytes in addition to PR3-ANCA at monitoring).
Danish: Fortsat immunsuppressiv behandling kan være særlig hensigtsmæssig for patienter med risiko for relaps (dvs. med en anamnese med tidligere relaps og granulomatose med polyangiitis eller patienter med rekonstituering af B-lymfocytter i tillæg til PR3-ANCA ved monitorering).
English: Based upon investigator judgment, 15 patients received a second course of rituximab therapy for treatment of relapse of disease activity which occurred between 6 and 18 months after the first course of rituximab.
Danish: På baggrund af investigators skøn gennemgik 15 patienter endnu et forløb med rituximab til behandling af recidiverende sygdom opstået mellem 6 og 18 måneder efter første rituximab-forløb.
English: 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).
Danish: 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
English: • you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis or microscopic polyangiitis.
Danish: • du har svært nedsat hjertefunktion eller svær, ukontrolleret hjertesygdom og har, granulomatose med polyangiitis eller mikroskopisk polyangiitis.
English: Regular full blood counts, including neutrophil and platelet counts, should be performed during
Danish: Regelmæssige, fuldstændige blodtællinger, inklusive neutrofil-og trombocyttællinger, bør udføres
English: Date of most recent infusion:
Danish: Dato for seneste fornyelse:
English: CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
Danish: CD20 cirkulerer ikke i plasmaet som et frit antigen og konkurrerer
English: There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6 % vs. 15.4 %).
Danish: Patienter med udbredt sygdom havde en højere hyppighed af grad 3 og 4 bivirkninger end patienter uden udbredt sygdom (25,6 % versus 15,4 %).
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Rituzena.
Danish: Hvis du er i den fødedygtige alder, skal du og din partner bruge sikker prævention, mens du er i behandling med Rituzena.
English: This is because some people have a fall in their blood pressure while they are being given Rituzena.
Danish: Nogle har oplevet, at blodtrykket faldt, mens de fik Rituzena
English: Mean Cmax was 16 to 19% higher following second infusion compared to the first
Danish: Gennemsnittet for Cmax var 16 til 19 % højere efter anden infusion sammenlignet med den første infusion for begge doser.
English: Treatment difference (Rituximab --cyclophosphamide)
Danish: Behandlingsforskel (rituximabcyclophosphamid)
English: Patients treated with Rituzena must be given the patient alert card with each infusion.
Danish: Patienter behandlet med Rituzena skal have udleveret patientkortet ved hver infusion.
English: A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 5a and Table 5b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 6) were analysed for efficacy.
Danish: I alt blev 810 patienter (403 R-FC, 407 FC) i 1. linje studiet (tabel 5a og tabel 5b) og 552 patienter (276 R-FC, 276 FC) i relaps/refraktær studiet (tabel 6) analyseret for effekt.
English: There was no increased rate in overall infections or serious infections in
Danish: Der var ingen stigning i den samlede hyppighed af infektioner eller af alvorlige infektioner hos patienter med lavt
English: Patients with human anti-mouse antibody or human anti-chimeric antibody (HAMA/HACA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Danish: Patienter med humant anti-mus antistof eller humant anti-kimært antistof titere (HAMA/HACA) kan få allergiske eller overfølsomhedsreaktioner, når de behandles med andre diagnostiske eller terapeutiske monoklonale antistoffer.
English: What you need to know before you use Rituzena Do not take Rituzena if:
Danish: Det skal du vide, før du begynder at få Rituzena Du må ikke få Rituzena, hvis:
English: Rituzena should be used in combination with CHOP chemotherapy.
Danish: Rituzena bør anvendes i kombination med CHOP kemoterapi.
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 5a).
Danish: Analyse af samlet overlevelse viste fortsat en signifikant fordel ved R-FC-behandling i forhold til FCkemoterapi (p = 0,0319, log-rank test) (tabel 5a).
English: • The need to check, prior to Rituzena treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned,
Danish: • Nødvendigheden af at kontrollere for infektioner, for immunsuppression, for tidligere/nuværende medicinering, der påvirker immunsystemet, og for nylige og/eller planlagte vaccinationer før behandling med Rituzena påbegyndes
English: It is not known whether Rituzena has an effect on you being able to drive or use any tools or
Danish: Det vides ikke, om Rituzena påvirker din evne til at køre motorkøretøj eller arbejde med maskiner.
English: The efficacy and safety of rituximab in maintenance therapy has not been established.
Danish: Rituximabs effekt og sikkerhed i vedligeholdelsesbehandling er ikke fastslået.
English: The Physician information about Rituzena should contain the following key elements: Information that the product should be administered as IV only to avoid administration route errors.
Danish: Informationen til lægen om Rituzena skal indeholde følgende nøgle-elementer: • Information om, at præparatet kun må administreres intravenøst for at undgå forkerte
English: Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle and any subsequent cycles if the lymphocyte count is still >25 x 109/L.
Danish: Det bør overvejes at give disse patienter første infusion med nedsat infusionshastighed eller at fordele dosis over to dage i første serie og hver af de efterfølgende serier, hvis lymfocyttallet stadig er > 25 x
English: CLL affects B-lymphocytes, which originate in the bone marrow and develop in the lymph nodes.
Danish: CLL påvirker B-lymfocytter, som kommer fra knoglemarven og dannes i lymfeknuderne.
English: In the relapsed/refractory CLL study grade ¾ thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in
Danish: I relaps/refraktær CLL-studiet blev trombocytopeni af grad ¾ rapporteret hos 11 % af patienterne i R-FC-gruppen sammenlignet med 9 % af patienterne i FC
English: • you have ever had heart problems (such as angina, palpitations or heart failure) or breathing
Danish: • du nogensinde har haft hjerteproblemer (f.eks. angina, hjertebanken eller hjertesvigt) eller
English: You will always be given Rituzena as a drip (intravenous infusion).
Danish: Rituzena gives altid i et drop (intravenøs infusion).
English: During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles), four patients (2 %) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Danish: I behandlingsperioden (induktionsbehandlingsfasen bestående af R-CHOP i højst 8 behandlingsserier) fik fire patienter (2 %) i R-CHOP-armen, alle med kardiovaskulære risikofaktorer, tromboemboliske cerebrovaskulære hændelser i den første behandlingsserie.
English: Patients received 2 x 1,000 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: 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, der kan være relateret til frigivelse af cytokiner og/eller andre kemiske mediatorer.
English: • short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of
Danish: • kortvarig stigning i antallet af bestemte antistoffer kaldet immunglobuliner i blodet (IgM), kemiske forstyrrelser i blodet forårsaget af nedbrydningen af døende kræftceller
English: Talk to your doctor, pharmacist or nurse before you are given Rituzena if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, inden du får Rituzena, hvis: