FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall safety profile was consistent with the well-established safety profile of MabThera in RA and GPA/MPA and no new adverse drug reactions were reported.
Danish: Den overordnede sikkerhedsprofil var i overensstemmelse med den i forvejen fastlagte sikkerhedsprofil for MabThera i rheumatoid artrit og GPA/MPA, og ingen nye bivirkninger blev rapporteret.
English: In the induction of remission clinical trial, at 6 months, in the MabThera group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline had low IgA, IgG and IgM levels, respectively, compared to 25%, 50% and 46% in the cyclophosphamide group.
Danish: I det kliniske studie med induktion af remission havde henholdsvis 27%, 58% og 51% af patienterne i Mabthera-gruppen med normale immunglobulin-niveauer ved baseline lave IgA-, IgG- og IgMniveauer ved måned 6 sammenlignet med henholdsvis 25%, 50% og 46% i cyclophosphamid-gruppen.
English: The overall response rate (ORR) in the intent-to-treat (ITT) population was 48 % (CI95% 41% - 56%) with a 6% complete response (CR) and a 42 % partial response (PR) rate.
Danish: Den samlede responsrate i intent-to-treat populationen var 48 % (95 % konfidensinterval: 41 %56 %) med 6 % komplet respons (CR) og 42 % partielt respons (PR).
English: A total of 117 patients (88 with GPA, 24 with MPA, and 5 with renal-limited ANCA-associated vasculitis) in disease remission were randomized to receive azathioprine (59 patients) or MabThera (58 patients) in a prospective, multi-center, controlled, open-label study.
Danish: I alt 117 patienter (88 med GPA, 24 med MPA og 5 med nyre-begrænset antineutrofil cytoplasmisk antistof (ANCA)-associeret vaskulitis) i sygdomsremission blev randomiseret til at få henholdsvis azathioprin (59 patienter) eller MabThera (58 patienter) i et prospektiv, kontrolleret, åbent multicenterstudie.
English: Regular full blood counts, including neutrophil and platelet counts, should be performed during MabThera therapy.
Danish: Regelmæssige, fuldstændige blodtællinger, inklusive neutrofil- og trombocyttællinger, bør udføres under MabThera-behandling.
English: Your doctor may need to take special care of you during your treatment with MabThera.
Danish: Du kan have behov for ekstra overvågning under din behandling med MabThera.
English: Primary efficacy Progression-free survival (median)
Danish: Primært effektmål Progressionsfri overlevelse (median)
English: Events of neutropenia were observed with MabThera treatment, the majority of which were transient and mild or moderate in severity.
Danish: Neutropeni har været observeret under MabThera behandling og i de fleste tilfælde var den forbigående og i mild eller moderat sværhedsgrad.
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 cynomolgusaber har ikke vist anden effekt end den forventede farmakologiske fjernelse af B-celler i perifert blod og i lymfevæv.
English: You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.
Danish: MabThera gives altid i et drop (intravenøs infusion) i starten af behandlingen.
English: Trials of MabThera 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.
Danish: Studier med MabThera 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.
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 dette er tilfældet, om symptomerne tyder på PML.
English: Peripheral B cell counts declined below normal following completion of the first dose of MabThera.
Danish: Det perifere B-celletal faldt til under normalområdet efter den første dosis af MabThera.
English: The proportions of MabThera treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of >0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Danish: Andelen af patienter behandlet med MabThera, som viste minimal klinisk relevant ændring (MCID) i HAQ-DI (defineret som et fald i individuel total score på > 0,22) var også højere end hos patienter, som fik methotrexat alene (tabel 14).
English: After this, you will be given MabThera as an injection under your skin.
Danish: Herefter gives MabThera som en indsprøjtning under huden.
English: Pack of 2 vials.
Danish: Pakninger med 2 hætteglas.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERANSVARLIG FOR BATCHFRIGIVELSE
English: These patients were treated either with MabThera monotherapy (as induction treatment or maintenance treatment following induction treatment) or in combination with chemotherapy.
Danish: Patienterne blev behandlet med enten MabThera monoterapi (som induktionsbehandling eller vedligeholdelsesbehandling efter induktionsbehandling) eller i kombination med med kemoterapi.
English: MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
Danish: MabThera er i kombination med methotrexat indiceret til behandling af svær, aktiv reumatoid artrit hos voksne patienter, som har haft et utilstrækkeligt respons på eller er intolerante over for andre sygdomsmodificerende antireumatiske lægemidler (DMARDs) inklusive en eller flere behandlinger med tumor-nekrose-faktor (TNF)-hæmmere.
English: Following induction of remission with other standard of care immunosuppressants, MabThera maintenance treatment should be initiated during the 4 week period that follows disease remission.
Danish: Efter induktion af remission med andre immunsuppresiva til standardbehandling skal MabThera vedligeholdelsesbehandling initieres i løbet af en 4 ugers periode efter opnåelse af sygdomsremission.
English: A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to MabThera maintenance therapy (n=167) or observation (n=167).
Danish: De i alt 334 patienter, der opnåede komplet eller partiel remission efter induktionsbehandlingen, blev efterfølgende randomiseret til MabThera-vedligeholdelsesbehandling (n=167) eller observation (n=167).
English: For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Danish: For patienter randomiseret til vedligeholdelsesfasen i studiet var den mediane observationstid 28 måneder fra vedligeholdelsesrandomisering.
English: Elderly No dose adjustment is required in elderly patients (aged >65 years).
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre patienter (alder > 65 år).
English: For subjects weighing 60-90 kg and < 60 kg, average Ctrough values following intravenous dosing were approximately 16% and 34% lower compared to the subcutaneous regimen, respectively.
Danish: For patienter, der vejer 60-90 kg og < 60 kg, var den gennemsnitlige Ctrough værdi efter intravenøs dosering lavere, henholdsvis ca. 16 % og 34 %, sammenlignet med subkutan dosering.
English: The Patient Alert Card for MabThera in non-oncology indications should contain the following key elements:
Danish: Patientkortet for MabThera for non-onkologiske indikationer skal indeholde følgende nøgleelementer:
English: MabThera was administered as two IV infusions separated by an interval of 15 days.
Danish: MabThera blev administreret som to i.v.-infusioner med et interval på 15 dage.
English: If a patient develops PML, the dosing of MabThera must be permanently discontinued.
Danish: Hvis en patient udvikler PML, skal behandling med MabThera seponeres permanent.
English: Progression of Kaposi's sarcoma has been observed in MabThera-exposed patients with pre-existing Kaposi's sarcoma.
Danish: Der er observeret progression af Kaposis sarkom hos MabThera-eksponerede patienter med Kaposis sarkom.
English: The overall rate of infection was approximately 94 per 100 patient years in MabThera treated patients.
Danish: Den samlede hyppighed af infektioner var ca. 94 pr. 100 patientår hos patienter behandlet med MabThera.
English: Severe infusion-related reactions with fatal outcome have been reported during post-marketing use of the MabThera intravenous formulation, with an onset ranging within 30 minutes to 2 hours after starting the first MabThera intravenous infusion.
Danish: Der er efter markedsføring rapporteret svære infusionsrelaterede reaktioner med dødeligt udfald ved brug af MabThera i intravenøs formulering, med indtræden inden for 30 minutter til 2 timer efter påbegyndelse af første MabThera intravenøs infusion.
English: Therefore vaccination with live virus vaccines is not recommended whilst on MabThera or whilst peripherally B cell depleted.
Danish: Derfor kan vaccination med levende, virale vacciner ikke anbefales samtidig med MabThera behandling, eller mens der er perifer B-celle depletion.
English: The safety of immunisation with live viral vaccines following MabThera therapy has not been studied.
Danish: Sikkerheden ved vaccination med levende, virale vacciner efter behandling med MabThera er ikke undersøgt.
English: Table 5 Adverse drugs reactions for MabThera-treated pemphigus vulgaris patients in the clinical study up to month 24
Danish: Tabel 5 Bivirkninger opstået hos MabThera-behandlede patienter med pemfigus vulgaris i det kliniske studie op til måned 24
English: In trial SparkThera, no severe administration-related reactions were reported.
Danish: I SparkThera studiet rapporteredes ingen svære administrationsrelaterede reaktioner.
English: A total of 64 patients with CLL were enrolled at any point prior to cycle 5 during their treatment with MabThera intravenous formulation in combination with chemotherapy.
Danish: I alt 64 patienter med CLL blev inkluderet i studiet på et hvilket som helst tidspunkt før serie 5 i deres behandling med intravenøs MabThera i kombination med kemoterapi.
English: In the clinical trial on induction of remission, which included 99 MabThera-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
Danish: I det kliniske studie med induktion af remission, som inkluderede 99 MabThera-behandlede patienter var den samlede infektionshyppighed ca. 237 pr. 100 patientår (95% konfidensinterval 197-285) ved det primære endepunkt ved måned 6.
English: In studies of MabThera 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 MabThera 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: Although MabThera is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
Danish: Selvom MabThera ikke er myelosuppressivt ved monoterapi, bør der udvises forsigtighed, når det overvejes at behandle patienter med neutrofiltal på < 1,5 x 109/l og/eller trombocyttal på < 75 x 109/l, da kliniske erfaringer hos denne population er begrænsede.
English: A total of 6/34 (18%) of MabThera treated patients from the maintenance therapy clinical trial developed ADA.
Danish: I alt 6 ud af 34 (18 %) MabThera-behandlede patienter fra det kliniske studie med vedligeholdelsesbehandling udviklede ADA.
English: Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among MabThera-treated PV patients, with a ≥ 2% absolute difference in incidence between the MabThera-treated group and the standard-dose prednisone group up to month 24.
Danish: De bivirkninger, der opsummeres i tabel 5, forekom alle med en hyppighed ≥ 5 % blandt MabTherabehandlede patienter med PV med en ≥ 2 % absolut forskel i forekomst mellem den MabTherabehandlede-gruppe og standarddosis prednison-gruppen op til måned 24.
English: Significant reductions in disability index (HAQ-DI) and fatigue (FACIT-Fatigue) scores were observed in patients treated with MabThera compared to patients treated with methotrexate alone.
Danish: Signifikant reduktion i funktionsindeks (HAQ-DI) og træthedsscore (FACIT-Fatigue) blev observeret hos patienter, der blev behandlet med MabThera, sammenlignet med patienter behandlet med methotrexat alene.
English: MabThera 500 mg concentrate for solution for infusion EU/1/98/067/002
Danish: MabThera 500 mg koncentrat til infusionsvæske, opløsning EU/1/98/067/002
English: MabThera in combination with methotrexate significantly increased the proportion of patients achieving at least a 20 % improvement in ACR score compared with patients treated with methotrexate alone (Table 12).
Danish: MabThera i kombination med methotrexat øgede signifikant andelen af patienter, der opnåede mindst 20 % forbedring i ACR-score, sammenlignet med patienter behandlet med methotrexat alene (tabel 12).
English: MabThera was administered on the first day of each treatment cycle.
Danish: MabThera blev administreret på første dag af hver behandlingsserie.
English: Reactivation of hepatitis B infection has also been very rarely reported in RA patients receiving MabThera (see Section 4.4).
Danish: Der er meget sjældent blevet rapporteret om reaktivering af hepatitis B-infektion hos RA-patienter, som får MabThera (se pkt 4.4)
English: Geometric mean AUC values at cycle 7 µg.day/mL
Danish: Geometriske gennemsnitlige AUC-værdier ved behandlingsserie 7 µg.dag/ml
English: Aseptically withdraw the necessary amount of MabThera, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Danish: Under anvendelse af aseptiske procedurer trækkes den nødvendige mængde MabThera op og fortyndes til en beregnet koncentration på 1 til 4 mg/ml rituximab i en infusionspose, der indeholder steril, pyrogenfri natriumchloridopløsning til injektion 9 mg/ml (0,9 %) eller 5 % D-glukose i vand.
English: In the post-marketing setting five cases of MabThera overdose have been reported.
Danish: Efter markedsføring er der rapporteret fem tilfælde af MabThera-overdosering.
English: Patients treated with MabThera may receive non-live vaccinations.
Danish: Patienter som behandles med MabThera kan vaccineres med ikke-levende vacciner.
English: Log-Rank p value
Danish: Log-rank p værdi
English: A total of 19/34 (56%) patients with PV, who were treated with MabThera, tested positive for ADA antibodies by 18 months.
Danish: I alt 19 ud af 34 (56 %) patienter med PV, som blev behandlet med MabThera, testede positive for ADA antistoffer ved måned 18.
English: EULAR response (%)
Danish: Antallet af respondenter (respons-rate (%))
English: NR: not reached; a: only applicable to patients achieving a CR
Danish: NR: ikke opnået; a: kun gældende for patienter, der opnåede komplet respons
English: Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more MabThera treated patients treated with MabThera and methotrexate compared to patients treated with methotrexate alone (Table 12).
Danish: Ligeledes blev et godt til moderat European League Against Rheumatism (EULAR) respons i alle studier opnået af signifikant flere patienter behandlet med MabThera og methotrexat sammenlignet med patienter behandlet med methotrexat alene (tabel 12).
English: MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Danish: MabThera er indiceret til behandling af tidligere ubehandlede patienter med stadium III-IV follikulært lymfom i kombination med kemoterapi.
English: In patients treated for hematological 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: In embryofetal developmental studies in mice, rHuPH20 caused reduced fetal weight and loss of implantations at systemic exposures sufficiently in excess of human therapeutic exposure.
Danish: I embryoføtale udviklingsstudier med mus forårsagede rHuPH20 reduceret føtalvægt og fosterresorption ved systemisk niveau noget over det humane terapeutiske niveau.
English: In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58 % vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
Danish: I en subgruppeanalyse var den samlede responsrate højere hos patienter med histologisk subtype IWF B, C og D sammenlignet med subtype IWF A (58 % versus 12 %), højere hos patienter hvis største læsions længste diameter var < 5 cm versus > 7 cm (53 % versus 38 %) og højere hos patienter med kemoterapifølsomt relaps sammenlignet med kemoterapi-resistent relaps (defineret som en responsvarighed < 3 måneder) (50 % versus 22 %).
English: • What you need to know before having MabThera
Danish: • Hvad du skal vide, før du får MabThera
English: No PK/clinical data are available in patients with a refractory or relapsing disease.
Danish: Der er ingen farmakokinetiske/kliniske data tilgængelige hos patienter med en refraktær eller recediverende sygdom.
English: For subjects in the middle and low BSA tritiles, average Ctrough values following intravenous dosing were approximately 12% and 26% lower compared to the subcutaneous regimen.
Danish: For personer, der har et medium og lavt BSA, var den gennemsnitlige Ctrough værdi efter intravenøs dosering, henholdsvis ca. 12 % og 26 % lavere, sammenlignet med subkutan dosering.
English: Log--Rank p value
Danish: Log-rank p-værdi
English: The most frequent ADRs following receipt of MabThera in clinical studies were IRRs (refer to Table 2).
Danish: Den hyppigste bivirkning efter administration af MabThera i kliniske studier var infusionsrelaterede reaktioner (IRR) (se tabel 2).
English: Unopened vial 30 months
Danish: Uåbnet hætteglas 30 måneder.
English: The most frequently reported events were tachycardia (4%) and atrial fibrillation (3%) (see section 4.4).
Danish: De hyppigst rapporterede bivirkninger var takykardi (4%) og atrieflimren (3%) (se pkt.
English: MabThera should be used in combination with CHOP chemotherapy.
Danish: MabThera bør anvendes i kombination med CHOP kemoterapi.
English: The number of rituximab plus low-dose prednisone patients off prednisone therapy or on minimal therapy (prednisone dose of 10 mg or less per day) compared to standard-dose prednisone patients over the 24-month treatment period shows a steroid-sparing effect of MabThera (Figure 4).
Danish: Antallet af patienter behandlet med rituximab plus lavdosis prednison uden prednison-behandling eller behandlet minimalt (prednison dosis på 10 mg eller mindre pr. dag) viser en steroidbesparende virkning ad MabThera sammenlignet med patienter behandlet med standarddosis prednison over behandlingsperioden på 24 måneder (figur 4).
English: The efficacy and safety of MabThera in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicenter trial (Trial 1).
Danish: Effekt og sikkerhed af MabThera til lindring af symptomer og kliniske fund ved reumatoid artrit hos patienter med et utilstrækkelig respons på TNF-hæmmere blev vist i et pivotalt, randomiseret, kontrolleret, dobbeltblindet, multicenterstudie (studie 1).
English: In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β2 microglobulin, LDH, albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Danish: I alle patientundergrupper (køn, alder, aldersjusteret IPI, Ann Arbor stadie, ECOG, β2-mikrobuglobulin, LD, albumin, B-symptomer, udbredt sygdom, ekstranodale lymfomer, knoglemarvspåvirkning) var risikoratioen for hændelsesfri overlevelse og samlet overlevelse (RCHOP sammenlignet med CHOP) mindre end henholdsvis 0,83 og 0,95.
English: body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
Danish: legemsoverfladeareal én gang hver 3. måned (startende 3 måneder efter den sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (8 infusioner i alt).
English: Subsequent doses of MabThera can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Danish: Efterfølgende MabThera-doser kan infunderes med 100 mg/time initialt og øges med 100 mg/time hvert 30. minut til højst 400 mg/time.
English: When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Danish: Når MabThera gives i kombination med kemoterapi, bør standard dosisreduktioner for de kemoterapeutiske lægemidler anvendes.
English: Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Danish: Rituximab bindes specifikt til det transmembrane antigen, CD20, et non-glycosyleret phosphoprotein som findes på præ-B og modne B-lymfocytter .
English: MabThera subcutaneous formulation should be injected subcutaneously into the abdominal wall and never into areas where the skin is red, bruised, tender, hard or areas where there are moles or scars.
Danish: MabThera subkutan formulering skal injiceres subkutant i abdominalvæggen og aldrig i et område, hvor huden er rød, øm, hård, eller hvor der er blå mærker, skønhedspletter eller ar.
English: All of these arrhythmias either occurred in the context of a MabThera infusion or were associated with predisposing conditions such as fever, infection, acute myocardial infarction or pre-existing respiratory and cardiovascular disease.
Danish: Alle disse arytmier forekom enten i sammenhæng med MabThera-infusionen eller var forbundet med prædisponerende forhold som feber, infektion, akut myokardieinfarkt eller allerede eksisterende respiratorisk og kardiovaskulær sygdom.