FrancophonIA/ELRC3.0 huggingface dataset:
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Rixathon.
Danish: • Vis dette kort til enhver læge, sygeplejerske eller tandlæge, som er involveret i din behandling - og ikke kun til den læge, der udskriver Rixathon til dig
English: Risk reduction
Danish: Risikoreduktion
English: A Patient Alert Card will be included in the carton.
Danish: Et patientkort medfølger i æsken.
English: The need for further courses should be evaluated 24 weeks following the previous course.
Danish: Behovet for flere behandlingsserier skal evalueres 24 uger efter den foregående behandlingsserie.
English: The most frequent reported or observed serious adverse drug reactions (ADRs) were:
Danish: De hyppigst beskrevne eller observerede alvorlige bivirkninger var:
English: Neither age, sex, lymphoma grade, initial diagnosis, presence or absence of bulky disease, normal or high LDH nor presence of extranodal disease had a statistically significant effect (Fisher's exact test) on response to rituximab.
Danish: Hverken alder, køn, lymfomgrad, initial diagnose, tilstedeværelse eller fravær af udbredt sygdom, normal eller høj LD, eller tilstedeværelse af ekstranodal sygdom havde statistisk signifikant effekt (Fisher's exact test) på responset på rituximab.
English: • changes in the rhythm of the heart, or the heart beating faster than normal
Danish: • ændringer i hjerterytmen, eller hjertet slår hurtigere end normalt.
English: Figure 2: ACR responses for 4 treatment courses (24 weeks after each course (within patient, within visit) in patients with an inadequate response to TNF-inhibitors (n=146)
Danish: Figur 2: ACR-respons for fire behandlingsserier (24 uger efter hver behandlingsserie (inden for patient og besøg) hos patienter med et utilstrækkeligt respons over for TNFhæmmere (n=146)
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including progressive multifocal leukoencephalopathy (PML).
Danish: Patientkortet indeholder vigtige oplysninger om sikkerhed for patienterne angående potentiel øget risiko for infektioner, herunder progressiv multifokal leukoencefalopati (PML).
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials
Danish: 1 Hyppigheden stammer fra laboratorie-værdier, som var indsamlet som en del af rutinemæssig laboratorie-overvågning i kliniske studier
English: Alternative subsequent, faster, infusion schedule
Danish: Alternativ hurtigere infusionstid efterfølgende
English: Cumulative incidence over time of first major relapse
Danish: Kumulativ hyppighed over tid til første større recidiv
English: Rixathon will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Danish: Du får Rixathon af en læge eller sygeplejerske med erfaring i denne behandling.
English: The primary objective for the study was complete remission (complete epithelialisation and absence of new and/or established lesions) at month 24 without the use of prednisone therapy for two months or more (CRoff for ≥2 months).
Danish: Studiets primære formål var fuldstændig remission (fuldstændig epitelisering og fravær af nye og/eller etablerede læsioner) ved måned 24 uden brug af prednison-behandling i to eller flere måneder (CRoff ≥ 2 måneder).
English: Number of responders (response rate [%]) ap-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Danish: Antallet af respondenter (respons-rate (%)) ap-værdi er fra Fisher's exact test med mid-p korrektion b95 % konfidensinterval er korrigeret Newcombe interval
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue Rixathon.
Danish: Afhængig af sværhedsgraden af de infusionsrelaterede reaktioner og de nødvendige indgreb, skal Rixathon-behandlingen midlertidigt eller permanent afbrydes.
English: The safety and efficacy of rituximab in children below 18 years have not been established.
Danish: Pædiatrisk population Rituximabs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: EULAR response (%)
Danish: EULAR-respons (%)
English: Table 16 Percentage of patients who achieved complete remission at 6 months (intent-to-treat population*)
Danish: Tabel 16 Procentdel af patienter, der opnåede fuldstændig remission ved måned 6 (ITTpopulation*)
English: Skin papilloma * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
Danish: Hudpapillom * Infusionsrelaterede reaktioner inkluderede symptomer indsamlet ved næste planlagte besøg efter hver infusion samt bivirkninger, der forekom på dagen eller dagen efter infusionen.
English: A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of rituximab.
Danish: En lille andel af patienterne havde forlænget perifer B-celle-depletion, der varede 2 år eller mere efter sidste rituximab-dosis.
English: • If you are having Rixathon alone
Danish: • Hvis du får Rixathon alene
English: 40% of patients with bone marrow involvement responded compared to 59% of patients with no bone marrow involvement (p=0.0186).
Danish: 40 % af patienterne med involvering af knoglemarven responderede sammenlignet med 59 % af patienterne uden involvering af knoglemarven (p=0,0186).
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: • After aseptic dilution in glucose solution:
Danish: • Efter aseptisk fortynding i glukoseopløsning:
English: All patients in the cyclophosphamide arm received azathioprine maintenance therapy in during follow-up.
Danish: Alle patienter i cyclophosphamid-armen fik vedligeholdelsesbehandling med azathioprin under opfølgningen.
English: Make sure you have a list of all your medicines when you see a health care professional.
Danish: Sørg for altid at have en liste over al din medicin med til ethvert besøg hos lægen eller andet sundhedspersonale.
English: Rixathon is usually taken together with another medicine called methotrexate.
Danish: Rixathon bruges som regel sammen med et andet lægemiddel, kaldet methotrexat.
English: Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection.
Danish: Patienter, som en gang har haft leverbetændelse, vil blive omhyggeligt undersøgt af lægen for tegn på denne infektion.
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) during and after the 4 week induction course of Rixathon treatment.
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 de 4 ugers induktionsbehandling med Rixathon.
English: Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood.
Danish: Patienter med CLL har for mange unormale lymfocytter, som hovedsageligt ophobes i knoglemarven og blodet.
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: The antigen is expressed on > 95% of all B cell non-Hodgkin's lymphomas.
Danish: Antigenet udtrykkes på > 95 % af alle B-celle non-Hodgkin-lymfomer.
English: Your doctor may prescribe Rixathon for the treatment of:
Danish: Din læge kan ordinere Rixathon til behandling for:
English: Log-rank p value
Danish: Log-rank p værdi
English: Mean change from baseline: Modified total sharp score Erosion score Joint space narrowing score Proportion of patients with no radiographic change
Danish: Gennemsnitsændring fra baseline: Modificeret Total Sharp Score Erosionsscore Score for ledspalteforsnævring Andel af patienter uden radiologisk forandring
English: No incompatibilities between Rixathon and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
Danish: Der er ikke observeret uforligeligheder mellem Rixathon og polyvinylchlorid eller polyethylen infusionsposer eller infusionssæt.
English: These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection.
Danish: Disse ændringer inkluderer nedsat indhold af nogle specifikke proteiner i blodet (immunglobuliner), som hjælper med at beskytte mod infektioner.
English: Initiate at a rate of 250 mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes.
Danish: Begynd med en hastighed på 250 mg/time i de første 30 minutter og derefter 600 mg/time i de næste 90 minutter.
English: The consequences of long term B cell depletion in paediatric patients are unknown.
Danish: Konsekvenserne af B-celle-depletion over lang tid hos pædiatriske patienter kendes ikke.
English: † Outcome at 24 weeks Significant difference from placebo + MTX at the primary timepoint: ***p ≤ 0.0001
Danish: † resultat ved uge 24 Signifikant forskel fra placebo + MTX ved det primære tidspunkt: ***p ≤ 0,0001
English: Your doctor will check if you should have any vaccines before you receive Rixathon.
Danish: Din læge vil undersøge, om du bør vaccineres inden du får Rixathon.
English: Injury, Poisoning and Procedural Complications
Danish: Skader, forgiftninger og proceduremæssige komplikationer
English: There are no adequate and well-controlled data from studies in pregnant women, however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy.
Danish: Der foreligger ingen adækvate og velkontrollerede data fra studier hos gravide kvinder, men der er dog beskrevet forbigående B-celle depletion og lymfocytopeni hos børn af mødre, som har været eksponeret for rituximab under graviditeten.
English: The HCP Alert card addressing the correct use of Rixathon contains the following key elements: - The advice that Rixathon is for intravenous use only and recommendations how to ensure this route of administration
Danish: Sundhedspersonalekortet vedrørende korrekt anvendelse af Rixathon indeholder følgende nøgleelementer: - Rådet om, at Rixathon kun er til intravenøs anvendelse, og anbefalinger om, hvordan administrationsvejen sikres
English: Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL.
Danish: Der forekom infektioner (fortrinsvis bakterielle og virale) hos ca. 30-55 % af patienterne i de kliniske studier hos patienter med NHL samt hos 30-50 % af patienterne i de kliniske studier med CLL.
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy [PML]) and hepatitis C virus.
Danish: Nogle eksempler på disse alvorlige virusinfektioner er infektioner forårsaget af herpesvira (cytomegalovirus, varicella zoster virus og herpes simplex virus), JC virus (progressiv multifokal leukoencefalopati (PML)) og hepatitis C virus.
English: However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted postnatally and was accompanied by a decrease in IgG level in the newborn animals affected.
Danish: Dog blev der observeret dosisafhængigt farmakologisk B-celle depletion i fostrets lymfatiske organer, hvilket fortsatte efter fødslen og blev fulgt af et fald i IgG niveauet hos de påvirkede nyfødte dyr.
English: This analysis suggests that dose adjustment of rituximab with any of the tested covariates is not expected to result in a meaningful reduction in its pharmacokinetic variability.
Danish: Denne analyse antyder, at doseringsjusteringer baseret på de testede variable ikke forventes at give en relevant reduktion i den farmakokinetiske variation.
English: Prednisone dose tapering and the decision to stop prednisone treatment after month 18 were left at the investigator's discretion.
Danish: Prednison-dosisnedtitrering og beslutningen om at stoppe prednison-behandling efter måned 18 var op til investigators skøn.
English: Patients reporting signs and symptoms of infection following Rixathon therapy should be promptly evaluated and treated appropriately.
Danish: Patienter, der rapporterer signaler og symptomer på infektion efter behandling med Rixathon bør straks undersøges og behandles som nødvendigt.
English: Rixathon should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Danish: Rixathon skal anvendes under tæt supervision af erfarent sundhedspersonale i omgivelser, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt (se pkt.
English: Rixathon contains sodium
Danish: Rixathon indeholder natrium
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-upperioden.
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 < 1/1,000) and 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) og meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: When Rixathon is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Danish: Når Rixathon gives i kombination med kemoterapi, bør standard dosisreduktioner for de kemoterapeutiske lægemidler anvendes.
English: The incidence of infections that were serious or required intravenous antibiotics was approximately 4 per 100 patient years.
Danish: Hyppigheden af infektioner, som var alvorlige eller krævede i.v.-antibiotika, var ca. 4 pr. 100 patientår.
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01X C02
Danish: Farmakoterapeutisk klassifikation: antineoplastiske, monoklonale antistoffer, ATC kode: L01X C02
English: Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
Danish: Kronisk lymfatisk leukæmi (CLL) er den almindeligste form for leukæmi hos voksne.
English: The proliferation of these abnormal B-lymphocytes is the cause of symptoms you may have.
Danish: Det er formeringen af disse unormale B-lymfocytter, der er årsagen til de symptomer, du kan have.
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of Rixathon maintenance therapy, up to 5 years.
Danish: For patienter, som kan have højere risiko for recidiv, bør lægen overveje en længerevarende vedligeholdelsebehandling med Rixathon, i op til 5 år.
English: Consultation with a Neurologist should be considered as clinically indicated.
Danish: Henvisning til en neurolog skal overvejes, hvis det er klinisk relevant.
English: The highest intravenous dose of rituximab tested in humans to date is 5,000 mg (2,250 mg/m²), tested in a dose escalation study in patients with chronic lymphocytic leukaemia.
Danish: Den højeste intravenøse rituximab-dosis, der til dato er testet hos mennesker, er 5.000 mg (2.250 mg/m²), som er testet i et dosis-eskaleringsstudie med patienter med kronisk lymfocytisk leukæmi.
English: The best responses to Rixathon are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti- Cyclic Citrullinated Peptide (anti-CCP).
Danish: Den bedste virkning af Rixathon ses hos dem, som har en positiv blodprøve for reumafaktor (RF) og /eller for antistoffer mod cyklisk citrullinerede peptider (anti-CCP).
English: Patients were excluded from the study in relapsed/refractory CLL if they had previously been treated with monoclonal antibodies or if they were refractory (defined as failure to achieve a partial remission for at least 6 months) to fludarabine or any nucleoside analogue.
Danish: Patienter blev ekskluderet fra relaps/refraktær CLLstudiet, hvis de tidligere havde været behandlet med monoklonale antistoffer, eller hvis de var refraktære (defineret som manglende evne til at opnå partiel remission i mindst 6 måneder) over for fludarabin eller enhver anden nukleosidanalog.
English: Sodium citrate Polysorbate 80
Danish: Natriumcitrat Polysorbat 80
English: Other rarely-reported side-effects due to rituximab include a decreased number of white cells in the blood (neutrophils) that help to fight against infection.
Danish: Andre sjældent rapporterede bivirkninger af rituximab inkluderer nedsættelse i antallet af hvide blodlegemer (neutrofiler), som hjælper med at bekæmpe infektioner.
English: Prednisone tapering was to be completed by 6 months from the start of trial treatment.
Danish: Nedtitrering af prednison skulle være gennemført 6 måneder efter start af studiebehandling.
English: Very rare cases of fatal PML have been reported following use of rituximab.
Danish: Meget sjældne tilfælde af PML med dødeligt udfald er blevet rapporteret efter anvendelse af rituximab.
English: In clinical trials fewer than 1% (17/3,189) of patients experienced a serious IRR.
Danish: I kliniske studier fik færre end 1 % (17/3.189) af patienterne en alvorlig IRR.
English: However with non-live vaccines response rates may be reduced.
Danish: Dog kan responsrater efter vaccination med ikke-levende vacciner være nedsat.
English: Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61% with rituximab maintenance treatment when compared to observation (95% CI; 45% - 72%).
Danish: Ved anvendelse af Cox regressionsanalyse var risiko for forekomst af progressiv sygdom eller død reduceret med 61 % med rituximab vedligeholdelsesbehandling sammenlignet med observation (95 % konfidensinterval: 45 % - 72 %).
English: Vaccination should be completed at least 4 weeks prior to first administration of Rixathon.
Danish: Vaccinationerne bør være gennemført senest 4 uger inden første dosis af Rixathon.
English: Respiratory system Cases of interstitial lung disease, some with fatal outcome have been reported.
Danish: Det respiratoriske system Tilfælde af interstitiel lungesygdom, hvoraf nogle med dødelig udgang, er blevet rapporteret.
English: Fourteen patients (37%) in the rituximab group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
Danish: 14 patienter (37 %) i rituximab-gruppen oplevede behandlingsrelaterede infektioner sammenlignet med 15 patienter (42 %) i standarddosis prednison-gruppen.
English: Kaplan-Meier estimated progression- free rates at 12 months were 78% in the rituximab maintenance group vs. 57% in the observation group.
Danish: Kaplan-Meier estimeret sandsynlighed for progressionsfrihed ved 12 måneder var 78 % i rituximab vedligeholdelsesgruppen mod 57 % i observationsgruppen.
English: A total of 1,078 patients responded to induction therapy, of which 1,018 were randomised to rituximab maintenance therapy (n=505) or observation (n=513).
Danish: I alt 1.078 patienter responderede på induktionsbehandling, hvoraf 1.018 blev randomiseret til rituximab vedligeholdelsesbehandling (n=505) eller observation (n=513).
English: • After aseptic dilution in sodium chloride solution:
Danish: • Efter aseptisk fortynding i natriumchloridopløsning:
English: Table 7 Overview of efficacy results for rituximab maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Danish: Tabel 7 Oversigt over effektdata for rituximab vedligeholdelsesbehandling versus observation ved den protokol-definerede primær analyse og efter 9 års median opfølgningstid (final analyse)
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Rixathon Alert Card for patients with non-oncology diseases
Danish: TEKST PÅ PATIENTKORT FOR IKKE-ONKOLOGISKE INDIKATIONER Rixathon-patientkort for ikke-onkologiske indikationer
English: A diagnosis of PRES/RPLS requires confirmation by brain imaging.
Danish: Diagnosen PRES/RPLS kræver bekræftelse ved en hjernescanning.
English: If a patient develops PML, the dosing of Rixathon must be permanently discontinued.
Danish: Hvis en patient udvikler PML, skal behandlingen med Rixathon seponeres permanent.
English: • high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “LDH” in the blood, low calcium levels in the blood
Danish: • højt blodsukker, vægttab, hævelse i ansigt og krop, høje niveauer af enzymet LD (laktatdehydrogenase) i blodet, lavt indhold af kalk i blodet
English: Duration of response * Disease free survival (DFS)** Time to new CLL treatment
Danish: Responsvarighed* Sygdomsfri overlevelse (DFS)** Tid indtil ny CLL-behandling
English: % SF-36 PHS MCID Mean change in SF-36 MHS % SF-36 MHS MCID † Outcome at 24 weeks 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: 9.25 years
Danish: 9,25 år
English: Rixathon contains the active substance “rituximab”.
Danish: Rixathon indeholder det aktive indholdsstof rituximab.
English: A total of 392/3,095 (12.7%) patients with rheumatoid arthritis tested positive for ADA in clinical studies following therapy with rituximab.
Danish: Samlet blev 392/3.095 (12,7 %) af patienterne med reumatoid artrit testet positive for ADA i kliniske studier efter behandling med rituximab.
English: Rixathon is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects.
Danish: Rixathon anvendes til at behandle reumatoid artrit hos personer, der allerede har prøvet anden medicin, men hvor denne medicin enten er holdt op med at virke, ikke har virket godt nok eller har medført bivirkninger.
English: Rituximab maintenance treatment reduced the risk of death by 56% (95% CI; 22% - 75%).
Danish: Rixathon vedligeholdelsesbehandling reducerede risikoen for død med 56 % (95 % konfidensinterval: 22 % - 75 %).
English: Very Rare Not known
Danish: Meget almindelig Almindelig almindelig Sjælden Meget sjælden Ikke kendt
English: • Excess fluid retention in the face and body
Danish: • væskeophobning i ansigtet og kroppen
English: Patients received 2 x 1,000 mg intravenous infusions of rituximab or placebo in combination with MTX.
Danish: Patienterne fik 2 × 1.000 mg intravenøs infusion af rituximab eller placebo i kombination med MTX.
English: At week 24, patients who were seropositive to RF and/or anti-CCP at baseline had a significantly increased probability of achieving ACR20 and 50 responses compared to seronegative patients (p=0.0312 and p=0.0096) (Table 15).
Danish: Ved uge 24 havde patienter, som ved baseline var seropositive for RF og/eller anti-CCP, en signifikant øget sandsynlighed for at opnå ACR20- og ACR50-repons sammenlignet med seronegative patienter (p=0,0312 og p=0,0096) (tabel 15).
English: Patients in a severely immunocompromised state.
Danish: Svært immunkompromitterede patienter