FrancophonIA/ELRC3.0 huggingface dataset:
English: In the PV population, 5 (13%) patients in the MabThera group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the MabThera group and 33 (92%) patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
Danish: I PV-populationen havde 5 (13 %) patienter i MabThera-gruppen og 3 (8 %) patienter i standarddosis prednison-gruppen moderat sygdom, og 33 (87 %) patienter i MabTheragruppen og 33 (92 %) patienter i standarddosis prednison-gruppen havde svær sygdom i henhold til sygdomssværhedsgrad defineret ved Harman's kriterier.
English: The clinical relevance of ADA formation in MabThera-treated PV patients is unclear.
Danish: Den kliniske relevans af dannelsen af ADA hos MabTherabehandlede patienter med PV er uklar.
English: In patients treated with cyclophosphamide (followed by azathioprine for maintenance of complete remission), 39% of patients achieved CR at 12 months, and 33% of patients achieved CR at 18 months.
Danish: I gruppen af patienter behandlet med cyclophosphamid (efterfulgt af azathioprin med henblik på opretholdelse af fuldstændig remission) opnåede 39% af patienterne fuldstændig remission ved måned 12 og 33% af patienterne fuldstændig remission ved måned 18.
English: Among the 3189 patients treated with MabThera, 1135 (36%) experienced at least one IRR with 733/3189 (23%) of patients experiencing an IRR following first infusion of the first exposure to MabThera.
Danish: Blandt de 3.189 patienter, som blev behandlet med MabThera, fik 1.135 (36 %) mindst en IRR, og 733/3.189 (23 %) af patienterne fik en IRR efter første infusion i den første MabThera-behandling.
English: Post-authorisation efficacy study (PAES): In order to further investigate the efficacy of Mabthera in the subgroup of patients with established PV as well as to further characterise its long term efficacy and safety on disease progression, the MAH should submit the preliminary study and the final study report of the ongoing randomised phase 3 study (PEMPHIX WA29330).
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For yderligere at undersøge effekten af Mabthera i subgruppen af patienter med etableret pemfigus vulgaris samt yderligere at karakterisere dets langsigtede effekt og sikkerhed ved sygdomsprogression, skal indehaveren af markedsføringstilladelsen indsende den forløbige studierapport og den endelige studierapport for det igangværende randomiserede fase III-studie (PEMPHIX WA29330).
English: Conditional simulations that summarized the impact of all body size dependencies on rituximab exposure demonstrated that, while fixed subcutaneous dosing leads to larger differences in exposure (Ctrough and AUCτ) between subjects with low and high body sizes compared to body-weight-adjusted intravenous dosing, it allows to maintain Ctrough and AUCτ values for all body-size groups at the levels not lower than levels attained by intravenous dosing, thus achieving at least the same target saturation as for intravenousdosing.
Danish: Betingede simuleringer, der opsummerer virkningen af kropsstørrelsens betydning på eksponeringen af rituximab, viste, at mens fast subkutan dosering medfører større forskelle i eksponeringen (Ctrough og AUCτ) mellem store og små kropsstørrelser sammenlignet med krops-vægtjusteret intravenøs dosering, tillader fast subkutan dosering fastholdelse af værdier for Ctrough og AUCτ for alle grupper af kropsstørrelser, på niveauer, der ikke er lavere end niveauer opnået med intravenøs dosering.
English: MabThera induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Danish: MabThera inducerede B-cellereduktion hos 70-80 % af patienterne, men blev kun ledsaget af nedsat serum-immunglobulin hos en mindre del af patienterne.
English: It is not known whether MabThera has an effect on you being able to drive or use any tools or machines.
Danish: Det vides ikke, om MabThera påvirker din evne til at køre motorkøretøj eller arbejde med maskiner.
English: Absorption parameters of subcutaneous formulation, decreased with increasing BMI.
Danish: Absorptionsparametre for den subkutane formulering faldt med øget Body Mass Index (BMI).
English: Exploratory analyses showed response rates among BSA, chemotherapy and gender subgroups were not notably different from the ITT population.
Danish: Eksplorative analyser viste, at responsraterne mht. legemsoverfladeareal (BSA), kemoterapi og kønsundergruppe ikke var markant anderledes fra intent-to-treat-populationen.
English: Cardiovascular reactions during clinical trials with MabThera monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Danish: I kliniske studier med MabThera monoterapi rapporteredes kardiovaskulære reaktioner hos 18,8 % af patienterne, hvoraf de hyppigst rapporterede var hypotension og hypertension.
English: Serious cardiac reactions were reported at a rate of 1.3 per 100 patient years in the MabThera treated patients compared to 1.3 per 100 patient years in placebo treated patients.
Danish: Alvorlige kardielle bivirkninger blev rapporteret med en hyppighed på 1,3 pr. 100 patientår hos patienter behandlet med MabThera sammenlignet med 1,3 pr. 100 patientår hos patienter behandlet med placebo.
English: Neutropenia can occur several months after the administration of MabThera (see section 4.4).
Danish: Neutropeni kan forekomme flere måneder efter indgivelse af MabThera (se pkt.
English: The highest intravenous dose of MabThera tested in humans to date is 5000 mg (2250 mg/m2), tested in a dose escalation study in patients with CLL.
Danish: Den højeste intravenøse MabThera-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: If you can get pregnant, you and your partner must use an effective method of contraception while using MabThera.
Danish: Hvis du er i den fødedygtige alder, skal du og din partner bruge sikker prævention, mens du er i behandling med MabThera.
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti- Cyclic Citrullinated Peptide (anti-CCP) who were treated with MabThera in combination with methotrexate showed an enhanced response compared to patients negative to both.
Danish: Effekt hos autoantistof (RF og/eller anti-CCP) seropositive patienter Patienter, som er seropositive for reumafaktor (RF) og/eller antistoffer mod cyklisk citrullinerede peptider (anti-CCP), og som blev behandlet med MabThera i kombination med methotrexat, viste et øget respons sammenlignet med patienter, som var negative for begge.
English: Ctrough values at pre-dose cycle 8
Danish: Ctrough-værdier inden dosering i behandlingsserie 8
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for MabTheratreated patients vs 5% for azathioprine treated patients.
Danish: I det kliniske studie med vedligeholdelsesbehandling var hyppigheden af alle grader neutropeni 0 % for MabThera-behandlede patienter vs 5 % for azathioprin-behandlede patienter.
English: Results from trial BP22333 are presented in section 5.2.
Danish: Resultaterne fra Studie BP22333 præsenteres i pkt.
English: Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Danish: Patienter med positiv hepatitis B serologi (enten HBsAg eller HBcAb) bør inden påbegyndelse af behandling konsultere en specialist i leversygdomme og bør overvåges og behandles i henhold til lokale kliniske standarder for at forebygge hepatitis B reaktivering.
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 MabThera treatment.
Danish: 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 MabThera.
English: If patients did not experience a serious infusion-related reaction with their first or subsequent infusions of a dose of 1000 mg MabThera administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/mL in a 250 mL volume).
Danish: Hvis patienten ikke har oplevet en alvorlig infusionsrelateret reaktion ved den første eller efterfølgende infusioner af en MabThera-dosis på 1.000 mg administreret ud fra den oprindelige infusionstid, kan de efterfølgende infusioner administreres som en hurtigere infusion ved at bruge den samme koncentration som ved tidligere infusioner (4 mg/ml i 250 ml).
English: Patients who experience overdose or medication error should be closely monitored.
Danish: Patienter, som oplever overdosis eller medicineringsfejl, skal monitoreres tæt.
English: Product information Physician information Patient information Patient Alert card
Danish: Produktresuméet Information til lægen Information til patienten Patientkort
English: However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted post natally 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: In the MabThera group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
Danish: I MabThera-gruppen opnåede 48% af patienterne fuldstændig remission ved måned 12, og 39% af patienterne opnåede fuldstændig remission ved måned 18.
English: Patient subpopulations - MabThera combination therapy Elderly patients (≥ 65 years)
Danish: Specielle populationer - MabThera kombinationsterapi Ældre (≥ 65 år):
English: Three patients (8%) in the MabThera group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Danish: 3 patienter (8 %) i MabThera-gruppen oplevede et samlet antal på 5 alvorlige infektioner (Pneumocystis jiroveci-pneumoni, infektiøs trombose, intervertebral diskitis, lungeinfektion, Staphylococcal-sepsis) og 1 patient (3 %) i standarddosis prednison-gruppen oplevede 1 alvorlig infektion (Pneumocystis jiroveci-pneumoni).
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 MabThera 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 MabThera under graviditeten.
English: MabThera 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: MabThera skal anvendes under tæt supervision af erfarent sundhedspersonale i omgivelser, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt (se pkt.
English: During the development programme, the safety profile of MabThera subcutaneous formulation was comparable to that of the intravenous formulation with the exception of local cutaneous reactions.
Danish: I udviklingsprogrammet var sikkerhedsprofilen for MabThera subkutan formulering sammenlignelig med den for MabThera intravenøs formulering, bortset fra lokale hudreaktioner.
English: Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported.
Danish: Der blev rapporteret tilfælde af grad 3 eller 4 arytmi (inklusive ventrikulær og supraventrikulær takykardi) og angina pectoris under infusion.
English: • A complex of symptoms occurring within a few weeks of an infusion of MabThera including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
Danish: • et kompleks af symptomer, som forekommer inden for nogle få uger efter en infusion med MabThera, herunder allergiske reaktioner, såsom udslæt, kløe, ledsmerter, hævede lymfekirtler og feber
English: Patients in the MabThera group who relapsed could receive an additional infusion of MabThera 1000 mg in combination with reintroduced or escalated prednisone dose.
Danish: Patienter i MabThera-gruppen, som oplevede recidiv, kunne få en yderligere infusion med MabThera 1.000 mg i kombination med genindført eller optitreret prednison-dosis.
English: Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.
Danish: Andre rapporterede alvorlige bivirkninger omfatter hepatitis B-reaktivering og PML (se pkt.
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with MabThera.
Danish: Det anbefales, at immunglobulinniveauer måles før initiering af MabThera-behandling.
English: The MAH must ensure that all physicians who are expected to prescribe MabThera are provided with the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som kan forventes at udskrive MabThera, har modtaget følgende:
English: Each carton contains one vial.
Danish: Hver pakning indeholder et hætteglas.
English: The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions (<4%).
Danish: Forekomsten af symptomer på infusionsrelaterede reaktioner var højest under eller efter første infusion (9 %) og faldt med gentagende infusioner (< 4 %).
English: The objective of the Part 2 was to establish the non-inferiority in observed Ctrough levels between the selected MabThera subcutaneous dose and the reference MabThera intravenous dose.
Danish: Formålet med 2. del var at fastslå non-inferioriteten i observerede Ctrough-niveauer mellem den valgte MabThera subkutane dosis og reference Mabthera intravenøs dosis.
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, progressionsfri overlevelse, sygdomsfri overlevelse, varighed af respons) bekræftede behandlingseffekten af R-CHOP i forhold til CHOP.
English: No incompatibilities between MabThera and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
Danish: Der er ikke observeret uforligeligheder mellem MabThera og polyvinylchlorid eller polyethylen infusionsposer eller infusionssæt.
English: GLSG'00 CHOP, 205 R-CHOP, 223 18
Danish: CHOP, 205 R-CHOP, 223
English: MabThera is indicated in adults for Non-Hodgkin's lymphoma (NHL):
Danish: MabThera er indiceret hos voksne til Non-Hodgkin-lymfom (NHL):
English: Use of MabThera may be associated with an increased risk of progressive multifocal leukoencephalopathy (PML).
Danish: Brug af MabThera kan være forbundet med øget risiko for progressiv multifokal leukoencefalopati (PML).
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Det gælder også medicin, der ikke er på recept og naturlægemidler.
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 heavy-chain variable regionssekvenser.
English: In trial SABRINA, severe administration-related reactions (grade≥3) were reported in two patients
Danish: I SABRINA studiet rapporteredes svære administrationsrelaterede reaktioner (grad ≥3) hos 2 patienter
English: Vaccination should be completed at least 4 weeks prior to first administration of MabThera.
Danish: Vaccinationerne bør være gennemført senest 4 uger inden første dosis af MabThera.
English: As typical for monoclonal antibodies, rituximab PK parameters depended on body size measures.
Danish: Som det typisk ses ved monoklonale antistoffer, er de farmakokinetiske parametre for rituximab, afhængige af kropsmål.
English: No dose adjustment is required in elderly patients (aged >65 years).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter (alder > 65 år).
English: However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with MabThera and for 12 months following MabThera treatment.
Danish: Eftersom maternelt IgG imidlertid udskilles i humanmælk, og rituximab blev detekteret i mælk fra diegivende aber, bør kvinder ikke amme, når de behandles med MabThera og i 12 måneder efter afsluttet MabThera behandling.
English: A two-stage phase Ib trial to investigate the pharmacokinetics, safety and tolerability of MabThera subcutaneous formulation in patients with follicular lymphoma (FL) as part of maintenance treatment.
Danish: Et 2-delt fase Ib-studie der undersøgte farmakokinetik, sikkerhed og tolerabilitet af MabThera i subkutan formulering til patienter med follikulært lymfom (FL) som en del af vedligeholdelsesbehandlingen.
English: Figure 3: Cumulative incidence over time of first major relapse
Danish: Kumulative hyppighed over tid til første større recidiv
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, alle i opfølgningsperioden.
English: Maintenance infusions of MabThera 500 mg were administered at months 12 and 18.
Danish: En vedligeholdelsesinfusion af MabThera 500 mg blev administreret ved måned 12 og 18.
English: In the induction of remission clinical trial, 24% of patients in the MabThera group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Danish: I det kliniske forsøg med induktion af remission udviklede 24% af patienterne i MabThera-gruppen (ét forløb) og 23% af patienterne i cyclophosphamid-gruppen neutropeni af CTC-grad 3 eller derover.
English: The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for MabThera (see section 4.4).
Danish: Sikkerhedsinformationen, som er samlet efter markedsføring, afspejler den forventede bivirkningsprofil, dvs. den som blev set i kliniske studier med MabThera (se pkt.
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: MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Danish: MabThera anvendt sammen med kemoterapi ødelægger disse celler, som gradvis fjernes fra kroppen ved biologiske processer.
English: It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) and strength is being given to the patient, as prescribed.
Danish: Det er vigtigt at kontrollere lægemidlets etiket for at sikre, at den formulering (intravenøs eller subkutan) og styrke, der gives til patienten, er korrekt i henhold til ordinationen.
English: In a trial designed to evaluate the safety of a more rapid MabThera infusion in patients with rheumatoid arthritis, patients with moderate-to-severe active RA who did not experience a serious IRR during or within 24 hours of their first studied infusion were allowed to receive a 2-hour intravenous infusion of MabThera.
Danish: I et studie designet til at evaluere sikkerheden af en hurtigere MabThera-infusion hos patienter med reumatoid artrit kunne patienter med moderat til svær aktiv reumatoid artrit, som ikke havde oplevet en alvorlig infusionsrelateret reaktion under eller inden for 24 timer efter deres første infusion, få en 2 timers intravenøs MabThera-infusion.
English: Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001
Danish: Signifikant forskel fra placebo ved det primære tidspunkt: * p < 0,05, **p < 0,001 ***p ≤ 0,0001
English: Toxic Epidermal Necrolysis (Lyell's syndrome), Stevens-Johnson syndrome5
Danish: Toksisk epidermal nekrolyse (Lyells syndrom), StevensJohnsons syndrom5
English: MabThera maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p< 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Danish: MabThera-vedligeholdelsesbehandling forlængede signifikant den mediane PFS hos patienter, der responderede på CHOP-induktionsbehandling (median PFS 37,5 måneder versus 11,6 måneder, p<0,0001) såvel som hos dem, der responderede på R-CHOP induktionsbehandling (median PFS 51,9 måneder versus 22,1 måneder, p=0,0071).
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 såvel normale som maligne B-celler, men ikke på hæmatopoietiske stamceller, pro-Bceller, normale plasmaceller eller andet normalt væv.
English: A peel--off sticker is included on the vials which specifies the strength, route of administration and indication.
Danish: Et aftageligt klistermærke er påsat på hætteglassene, som angiver, styrke, adminisatrationsvej og indikation.
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 sås ingen forskel mellem R-CHOP- og CHOP-gruppen i forhold til incidens af andre grad 3 og 4 kardielle hændelser, inklusive hjertesvigt, myokardiesygdom og manifestationer af koronararteriesygdom.
English: Initial treatment in combination with chemotherapy
Danish: Induktionsbehandling i kombination med kemoterapi
English: MabThera may also cause changes in laboratory tests carried out by your doctor.
Danish: MabThera kan også ændre resultaterne på de blodprøver, som lægen har bestilt.
English: • The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 80 and water for injections.
Danish: • Øvrige indholdsstoffer: Rekombinant humant hyalorunidase (rHuPH20), L-histidin, L-histidin hydrochloridmonohydrat, α,α-trehalosedihydrat, L-methionin, polysorbat 80 og vand til injektionsvæsker.
English: It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) is being given to the patient, as prescribed.
Danish: Det er vigtigt at kontrollere lægemidlets etiket for at sikre, at den formulering (intravenøs eller subkutan), der gives til patienten, er korrekt i henhold til ordinationen.
English: Patients who experience overdose or medication error with MabThera should be closely monitored.
Danish: Patienter, som oplever overdosis eller medicineringsfejl med MabThera, skal monitoreres tæt.