FrancophonIA/ELRC3.0 huggingface dataset:
English: Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells.
Danish: Mulige effektor medierede celle lysis mekanismer inkluderer komplement afhængig cellulær cytotoksicitet (CDC) som et resultat af C1q binding og antistof afhængig cellulær cytotoksicitet (ADCC) medieret ved en eller flere af Fcγ receptorerne på overfladen af granulocytter, makrofager og NK celler.
English: At this time, the infusion can be initially resumed at not more than one-half the previous rate.
Danish: På dette tidspunkt kan infusionen genoptages, dog ikke med mere end halvdelen af den tidligere infusionshastighed.
English: Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Danish: Specielle populationer - rituximab kombinationsterapi Ældre (≥ 65 år):
English: The majority of patients were ANCApositive at diagnosis or during the course of their disease; had histologically confirmed necrotizing small-vessel vasculitis with a clinical phenotype of GPA/MPA, or renal limited ANCA-associated vasculitis; or both.
Danish: Størstedelen af patienterne var ANCA-positive ved diagnosen eller i løbet af deres sygdomsforløb, havde histologisk bekræftet nekrotiserende små-kar vaskulitis med en klinisk fænotype af GPA/MPA eller nyre-begrænset ANCA-associeret vaskulitis, eller begge.
English: hours after infusion
Danish: 24 timer efter infusion
English: 6.11 years
Danish: 6,11 år
English: You will always be given Ritemvia as a drip (intravenous infusion).
Danish: Ritemvia gives altid i et drop (intravenøs infusion).
English: The rate of serious infections was approximately 25 per 100 patient years.
Danish: Hyppigheden af alvorlige infektioner var ca. 25 pr. 100 patientår.
English: However, the higher incidence of neutropenia in patients treated with rituximab and chemotherapy was not associated with a higher incidence of infections and infestations compared to patients treated with chemotherapy alone.
Danish: Den højere hyppighed af neutropeni hos patienter behandlet med rituximab og kemoterapi var dog ikke forbundet med en højere hyppighed af infektioner og infestationer sammenlignet med patienter, som fik kemoterapi alene.
English: In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following rituximab.
Danish: Hos patienter med reumatoid artrit fik 283 patienter efterfølgende behandling med et biologisk DMARD efter rituximab.
English: The analysis of all secondary parameters (response rates, progression-free survival, disease-free survival, duration of response) verified the treatment effect of R-CHOP compared to CHOP.
Danish: Analysen af alle sekundære parametre (responsrate, progresionsfri overlevelse, sygdomsfri overlevelse, varighed af respons) bekræftede behandlingseffekten af R-CHOP i forhold til CHOP.
English: • The need to provide patients with the Patient Alert Card with each infusion
Danish: • Nødvendigheden af at udlevere patientkortet ved hver infusion
English: • Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML
Danish: • Detaljeret information om risikoen for PML, nødvendigheden af at diagnosticere PML i tide og egnede metoder til at diagnosticere PML
English: EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
Danish: EFS - Hændelsesfri overlevelse TTP - Tid til progression eller død PFS - Progressionsfri overlevelse TTF - Tid til behandlingssvigt
English: • nerve damage in arms and legs, paralysed face
Danish: • nerveskader i arme og ben, lammelse af ansigtet
English: If you respond well to treatment, you may be given Ritemvia as a maintenance treatment.
Danish: Hvis du reagerer godt på behandlingen, kan du få Ritemvia som vedligeholdelsesbehandling.
English: Very rare cases of fatal PML have been reported following the use of rituximab.
Danish: Meget sjældne tilfælde af PML med dødeligt udfald er blevet rapporteret efter anvendelse af rituximab.
English: In all these studies, rituximab pharmacokinetics were dose proportional over the limited dose range studied.
Danish: I alle disse studier var farmakokinetikken for rituximab proportional med dosis inden for det begrænsede dosisinterval, som blev undersøgt.
English: Structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Danish: Strukturel ledskade blev vurderet radiologisk og udtrykt som ændring i modificeret Total Sharp Score (mTSS) og dets bestanddele erosionsscore og score for ledspalteforsnævring.
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: Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences.
Danish: Rituximab er et gensplejset chimerisk muse/humant monoklonalt antistof der repræsenterer et glycosyleret immunglobulin med humane IgG1 konstante regioner og murine light-chain og heavychain variable regionssekvenser.
English: The trial demonstrated non-inferiority of rituximab to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Danish: Studiet viste non-inferioritet af rituximab i forhold til cyclophosphamid med hensyn til fuldstændig remission (CR) ved måned 6 (tabel 16).
English: Disease activity outcomes
Danish: Resultat for sygdomsaktivitet
English: Patients treated with rituximab may receive non-live vaccinations.
Danish: Patienter, som behandles med rituximab, kan vaccineres med ikke-levende vacciner.
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: Rituximab has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Danish: Rituximab er blevet anvendt til 21 patienter, som havde fået foretaget autolog knoglemarvstransplantation, og til andre risikogrupper med formodet nedsat knoglemarvsfunktion uden at fremkalde myelotoksicitet.
English: The primary outcome measure was the rate of major relapse at month 28.
Danish: Det primære endepunkt var hyppigheden af større recidiver ved måned 28.
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC02.
Danish: Farmakoterapeutisk klassifikation: antineoplastiske, monoklonale antistoffer, ATC kode: L01XC02
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: Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the rituximab group (12%) and eight patients in the azathioprine group (14%).
Danish: Mindre recidiver (ikke livstruende og som ikke involverede større organskader) opstod hos 7 patienter i rituximab-gruppen (12 %) og 8 patienter i azathioprin-gruppen (14 %).
English: Hepatitis B Infections
Danish: Hepatitis B-infektioner
English: In patients treated for haematological malignancies, B cell recovery began within 6 months of treatment and generally returned to normal levels within 12 months after completion of therapy, although in some patients this may take longer (up to a median recovery time of 23 months post-induction therapy).
Danish: Hos patienter behandlet for maligne hæmatologiske sygdomme begyndte B-celleregenerering inden for 6 måneders behandling og vendte normalt tilbage til normale niveauer inden for 12 måneder efter afsluttet behandling, selvom det hos nogle patienter kan tage længere tid (op til en median restitutionstid på 23 måneder efter induktionsbehandling).
English: There were no differences reported for the incidence of anaemia.
Danish: Der blev ikke rapporteret om forskelle i hyppigheden af anæmi.
English: Ritemvia contains the active substance “rituximab”.
Danish: Ritemvia indeholder det aktive indholdsstof rituximab.
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 3/4 bivirkninger end patienter uden udbredt sygdom (25,6 % versus 15,4 %).
English: Some cases of late neutropenia occurring more than four weeks after the last infusion of rituximab were reported.
Danish: Der blev rapporteret om nogle tilfælde af sen neutropeni, som indtraf mere end fire uger efter den sidste rituximab-infusion.
English: The study showed statistically significant results of rituximab and low-dose prednisone over standarddose prednisone in achieving CRoff ≥ 2 months at month 24 in PV patients (see Table 18).
Danish: Studiet viste statistisk signifikante resultater af rituximab og lavdosis prednison over standarddosis prednison ved at opnå CRoff ≥ 2 måneder ved måned 24 hos PV-patienter (se tabel 18).
English: A total of 321 patients (162 R-CVP, 159 CVP) received therapy and were analysed for efficacy.
Danish: I alt 321 patienter fik behandling (162 patienter fik R-CVP og 159 fik CVP) og blev analyseret for effekt.
English: All patients received concomitant 60 mg oral prednisone on days 2-7 and 30 mg on days 8-14 following the first infusion.
Danish: Alle patienter fik samtidig 60 mg oral prednison på dag 2 til 7 og 30 mg på dag 8 til 14 efter den første infusion.
English: Specific studies to determine the effects of rituximab on fertility have not been performed.
Danish: Der er ikke gennemført specifikke studier til at fastlægge rituximabs effekt på fertilitet.
English: The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Danish: Antistoffet fremstilles ved mammalian (kinesisk hamster ovarie) cellesuspensionskultur og renses ved affinitetskromatografi og ionbytning, inklusive specifik viral inaktivering og rensningsprocedurer.
English: The cumulative incidence rate curves showed that time to first major relapse was longer in patients with rituximab starting from month 2 and was maintained up to month 28 (Figure 3).
Danish: Den kumulative hyppighedskurve viste, at tiden til første større recidiv var længere hos patienter, der blev behandlet med rituximab startende fra måned 2 og blev opretholdt til måned 28 (figur 3).
English: Patients received 2 x 1000 mg intravenous infusions of rituximab or placebo in combination with MTX.
Danish: Patienterne fik 2 x 1.000 mg intravenøs infusion af rituximab eller placebo i kombination med MTX.
English: The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Danish: Lægen bør undersøge patienten for at fastslå, om symptomerne tyder på en neurologisk dysfunktion, og hvis det er tilfældet, om symptomerne tyder på PML.
English: The proportion of patients experiencing an infusion-related reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively.
Danish: Andelen af patienter, der oplevede en infusionsrelateret reaktion var henholdsvis 29 % (11 patienter), 40 % (15 patienter), 13 % (5 patienter) og 10 % (4 patienter) efter den første, anden, tredje og fjerde infusion.
English: Patients with human anti-mouse antibody (HAMA) or anti-drug antibody (ADA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Danish: Patienter med humant anti-mus antistof (HAMA) eller anti-lægemiddel antistof (ADA) titere kan få allergiske eller overfølsomhedsreaktioner, når de behandles med andre diagnostiske eller terapeutiske monoklonale antistoffer.
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: 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 CLL-studiet, 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: • Warning on the risk of infections and PML, including the symptoms
Danish: • Advarsel om risikoen for infektioner og PML, inklusive alle symptomer
English: The safety of immunisation with live viral vaccines following rituximab therapy has not been studied.
Danish: Sikkerheden ved vaccination med levende, virale vacciner efter behandling med rituximab er ikke undersøgt.
English: A higher proportion of patients receiving the original rituximab/MTX treatment also had no erosive progression over 56 weeks (Table 13).
Danish: En højere andel af de patienter, der havde fået rituximab/MTX fra starten, havde ingen erosionsprogression i løbet af de 56 uger (tabel 13).
English: • low number of white blood cells, with or without fever or blood cells called “platelets”
Danish: • lavt antal hvide blodlegemer med eller uden feber eller lavt antal blodplader
English: Duration of response* Disease free survival (DFS)** Time to new treatment
Danish: Responsvarighed* Sygdomsfri overlevelse (DFS)** Tid indtil ny behandling
English: In studies of rituximab in patients with Waldenstrom's macroglobulinaemia, transient increases in serum IgM levels have been observed following treatment initiation, which may be associated with hyperviscosity and related symptoms.
Danish: I studier med rituximab hos patienter med Waldenstroms makroglobulinæmi er der observeret forbigående stigning i koncentrationerne af serum IgM efter påbegyndelse af behandlingen, som kan være forbundet med hyperviskositet og relaterede symptomer.
English: Blood and lymphatic system disorders neutropenia1
Danish: Blod og lymfesystem neutropeni1
English: Each course of treatment is made up of two separate infusions which are given 2 weeks apart.
Danish: Hvert behandlingsforløb består af to separate infusioner, der gives med 2 ugers mellemrum.
English: Further, significantly higher proportion of patients achieved MCIDs for these scores (Table 14).
Danish: Derudover opnåede en signifikant højere andel af patienterne MCIDs for disse scores (tabel 14).
English: Herpes virus infection Herpes zoster Oral herpes Conjunctivitis
Danish: Herpes virus infektion Herpes zoster Oral herpes Konjunktivitis
English: A total of 1078 patients responded to induction therapy, of which 1018 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: 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: This is because some people have a fall in their blood pressure while they are being given Ritemvia.
Danish: Nogle har oplevet, at blodtrykket faldt, mens de fik Ritemvia
English: Toxicity studies in cynomolgus monkeys have shown no other effect than the expected pharmacological depletion of B cells in peripheral blood and in lymphoid tissue.
Danish: Toksikologiske undersøgelser på Cynomolgus aber har ikke vist anden effekt end den forventede farmakologiske fjernelse af B-celler i perifert blod og i lymfevæv.
English: Trial 1 evaluated 517 patients that had experienced an inadequate response or intolerance to one or more TNF inhibitor therapies.
Danish: Studie 1 evaluerede 517 patienter, som havde utilstrækkeligt respons eller intolerans over for behandling med en eller flere TNF-hæmmere.
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Det gælder også medicin, der ikke er på recept, og naturlægemidler.
English: In general, the proportion of patients experiencing any infusion reaction was higher following the first infusion than following the second infusion of any treatment course.
Danish: Generelt var andelen af patienter, som fik en infusionsreaktion, uanset type, højere efter den første infusion end efter den anden infusion for alle behandlingsserier.
English: If you are having Ritemvia with other medicines, some of the side effects you may get may be due to the other medicines.
Danish: Hvis du får Ritemvia sammen med anden medicin, kan nogle bivirkninger være forårsaget af den anden medicin.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: CD20 is found on both normal and malignant B cells, but not on haematopoietic stem cells, pro-B cells, normal plasma cells or other normal tissue.
Danish: CD20 findes på både normale og på maligne B-celler, men ikke på tidlige forstadier, pro-B-celler, normale plasmaceller eller andet normalt væv.
English: The clinical relevance of ADA formation in rituximab-treated PV patients is unclear.
Danish: Den kliniske relevans af dannelsen af ADA hos rituximab- behandlede patienter med PV er uklar.
English: No difference between the R-CHOP and CHOP group was observed in the incidence of other grade 3 and 4 cardiac events including heart failure, myocardial disease and manifestations of coronary artery disease.
Danish: Der blev ikke set forskelle mellem R-CHOP-og CHOP-grupperne med hensyn til andre kardiale hændelser af grad 3 og 4, herunder hjerteinsufficiens, myokardiesygdom og manifestationer af koronar arteriesygdom.
English: • low number of red blood cells (anaemia), low number of all blood cells
Danish: • lavt antal røde blodlegemer (anæmi), lavt antal af alle blodlegemer
English: Ask your pharmacist how to throw away medicines that you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Higher frequencies of infections overall, including grade 3 or 4 infections, were observed during rituximab maintenance treatment up to 2 years when compared to observation.
Danish: Der blev set en højere infektionshyppighed, herunder infektioner af grad 3 eller 4, under rituximab vedligeholdelsesbehandling i op til 2 år sammenlignet med observationsgruppen.
English: The rate of serious infections did not show any significant increase following multiple courses of rituximab.
Danish: Hyppigheden af alvorlige infektioner viste ingen signifikant forøgelse efter gentagne behandlingsserier med rituximab.
English: Regular full blood counts, including neutrophil and platelet counts, should be performed during rituximab therapy.
Danish: Regelmæssige, fuldstændige blodtællinger, inklusive neutrofil-og trombocyttællinger, bør udføres under rituximab-behandling.
English: 14 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: These patients were treated either with rituximab monotherapy (as induction treatment or maintenance treatment following induction treatment) or in combination with chemotherapy.
Danish: Patienterne blev behandlet med enten rituximab monoterapi (som induktionsbehandling eller vedligeholdelsesbehandling efter induktionsbehandling) eller i kombination med med kemoterapi.
English: • you have ever had heart problems (such as angina, palpitations or heart failure) or breathing problems.
Danish: • du nogensinde har haft hjerteproblemer (f.eks. angina, hjertebanken eller hjertesvigt) eller vejrtrækningsbesvær.
English: Laboratory evaluations
Danish: Laboratorie evalueringer
English: Patients treated with Ritemvia must be given the patient alert card with each infusion.
Danish: Patienter behandlet med Ritemvia skal have udleveret patientkortet ved hver infusion.
English: This will be administered as 2 separate infusions which are given 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years.
Danish: Dette vil blive givet som to seperate infusioner med to ugers mellemrum, efterfulgt af én infusion hver 6. måned i mindst 2 år.
English: The overall safety profile was consistent with the well-established safety profile for rituximab in approved autoimmune indications, including GPA/MPA.
Danish: Den overordnede sikkerhedsprofil var i overensstemmelse med den i forvejen fastlagte sikkerhedsprofil for rituximab i godkendte autoimmune indikationer, inklusiv GPA og MPA.
English: The most commonly reported events considered as ADRs were infusion-related reactions and infections.
Danish: De mest almindelige rapporterede hændelser betragtet som bivirkninger var infusionsrelaterede reaktioner og infektioner.
English: The safety of immunisation with live viral vaccines, following rituximab therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Danish: Sikkerheden for vaccination med levende, virale vacciner efter rituximab behandling er ikke undersøgt hos NHL og CLL patienter, og vaccination med levende, virale vacciner kan ikke anbefales.
English: • high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “lactate dehydrogenase (LDH)” in the blood, low calcium levels in the blood
Danish: • højt blodsukker, vægttab, hævelse i ansigt og krop, høje niveauer af enzymet laktatdehydrogenase (LDH) i blodet, lavt indhold af kalk i blodet
English: Initial treatment, in combination with chemotherapy
Danish: Induktionsbehandling i kombination med kemoterapi
English: • If you are having Ritemvia with chemotherapy Ritemvia will be given to you on the same day as your chemotherapy.
Danish: • Hvis du får Ritemvia sammen med kemoterapi Ritemvia gives samme dag som kemoterapien.
English: Severe infections were reported in about 4% of patients treated with rituximab monotherapy.
Danish: Der blev rapporteret om svære infektioner hos ca. 4 % af de patienter, der blev behandlet med rituximab monoterapi.