FrancophonIA/ELRC3.0 huggingface dataset:
English: Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 7).
Danish: Signifikant fordel af vedligeholdelsesbehandling med MabThera blev også set for de sekundære effektmål; hændelsesfri overlevelse (EFS), tid til næste anti-lymfom-behandling (TNLT), tid til næste kemoterapibehandling (TNCT) og samlet responsrate (ORR) i den primære analyse (tabel 7).
English: In stage 2, MabThera subcutaneous formulation at a fixed dose of 1400 mg was administered as subcutaneous injection during maintenance treatment, after at least one cycle of MabThera intravenous formulation to FL patients who had previously responded to MabThera intravenous formulation in induction.
Danish: I del 2 blev MabThera administreret som subkutan formulering i en fast dosis på 1400 mg ved subkutan injektion, i vedligeholdelsesbehandlingen efter mindst én behandlingsserie med MabThera intravenøs formulering til FL-patienter, som tidligere havde responderet på MabThera intravenøs formulering under induktionsbehandlingen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,600 mg/13.4 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1600 mg/13,4 ml
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Hvis du har yderligere spørgsmål vedrørende brugen af MabThera, kan du kontakte lægen, apotekspersonalet eller sundhedspersonalet.
English: Patient subpopulations - MabThera monotherapy
Danish: Specielle populationer - MabThera monoterapi
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of MabThera.
Danish: Lægemidler til behandling af hypersensitivitetsreaktioner, for eksempel epinephrin (adrenalin), antihistaminer og glukokortikoider, bør være tilgængelige til øjeblikkelig anvendelse, i tilfælde af en allergisk reaktion under administration af MabThera.
English: Neurologic events
Danish: Neurologiske sygdomme
English: Hypersensitivity to the active substance or to murine proteins, hyaluronidase or to any of the other excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, murine proteiner, hyalorunidase eller over for et eller flere af hjælpestofferne anført i pkt.
English: Geometric mean AUCτ cycle 2 (q3m)
Danish: Geometrisk gennemsnitligt AUCτ behandlingsseriee 2 (q3m)
English: Mean pre-therapeutic antibody titers against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella and varicella) were maintained for at least 6 months after treatment with MabThera.
Danish: Gennemsnittet af præterapeutiske antistof-titer for et udvalg af antigener (Streptococcus pneumoniae, influenza A, mæslinger, røde hunde og skoldkopper) blev bibeholdt i mindst 6 måneder efter behandling med MabThera.
English: Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with MabThera.
Danish: Gennemsnittet af præterapeutiske antistoftitere for et udvalg af antigener (Streptococcus pneumoniae, influenza A, mæslinger, røde hunde, skoldkopper) blev bibeholdt i mindst 6 måneder efter behandling med MabThera.
English: The 50 mL vial contains 500 mg of rituximab (10 mg/mL).
Danish: Hætteglasset med 50 ml indeholder 500 mg rituximab (10 mg/ml)
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS MabThera Alert Card for patients with non-oncology diseases
Danish: MabThera--patientkort for ikke-onkologiske indikationer
English: IgG immunoglobulins are known to cross the placental barrier.
Danish: Graviditet Det vides, at IgG-immunglobuliner kan passere placentabarrieren.
English: Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial and 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Danish: Hjælpestoffer: Dette lægemiddel indeholder 2,3 mmol (eller 52,6 mg) natrium pr. 10 ml hætteglas og 11,5 mmol (eller 263,2 mg) natrium pr 50 ml hætteglas.
English: You might get infections more easily during your treatment with MabThera.
Danish: Risikoen for infektioner kan øges under behandling med MabThera.
English: d) Granulomatosis with polyangiitis or microscopic polyangiitis MabThera is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Danish: Granulomatose med polyangiitis eller mikroskopisk polyangiitis MabThera gives i kombination med binyrebarkhormon, for at behandle sygdommen granulomatose med polyangiitis (blev tidligere kaldt Wegeners granulomatose) og mikroskopisk polyangiitis.
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the MabThera group and at a higher frequency than the comparator group.
Danish: De bivirkninger, der opsummeres i tabel 3, forekom alle med en hyppighed ≥ 5 % i MabTheragruppen og med en højere frekvens end sammenligningsgruppen.
English: The most common local cutaneous reactions in the MabThera subcutaneous arm were injection site erythema (13%), injection site pain (7%), and injection site oedema (4%).
Danish: De hyppigste lokale hudreaktioner i armen med subkutan MabThera var erytem ved injektionsstedet (13 %), smerter ved injektionsstedet (7 %) og ødemer ved injektionsstedet (4 %).
English: Musculoskeletal pain Pain in extremities
Danish: Muskuloskeletale smerter Ekstremitetssmerter Nervesystemet
English: The benefit of MabThera maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (table 6).
Danish: Fordelen ved MabThera-vedligeholdelsesbehandling blev bekræftet ved alle undergruppeanalyser, uafhængigt af induktionsbehandling (CHOP eller R-CHOP) eller grad af respons på induktionsbehandling (CR eller PR) (Tabel 6).
English: The most frequent adverse reactions considered due to receipt of MabThera were IRRs.
Danish: De mest almindelige bivirkninger, der blev anset for at være relateret til administration af MabThera, var infusionsrelaterede reaktioner.
English: The safety of immunisation with live viral vaccines, following MabThera 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 MabThera behandling er ikke undersøgt hos NHL og CLL patienter, og vaccination med levende, virale vacciner kan ikke anbefales.
English: Mean terminal elimination half-life ranged from 15 to 16 days for the 2 x 500 mg dose group and 17 to 21 days for the 2 × 1000 mg dose group.
Danish: Den gennemsnitlige terminale halveringstid for elimination varierede fra 15 til 16 dage for doseringsgruppen 2 x 500 mg og fra 17 til 21 dage for doseringsgruppen 2 x 1.000 mg.
English: 18-months p = 0.016
Danish: 18-måneder p=0,016
English: Geometric mean AUCτ cycle 2 (q2m)
Danish: Geometrisk gennemsnitligt AUCτ behandlingsserie 2 (q2m)
English: During MabThera maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Danish: Under vedligeholdelsesbehandling med MabThera i op til 2 år rapporteredes højere hyppighed af leukopeni (5 % versus 2 %, grad 3/4) og neutropeni (10 % versus 4 %, grad 3/4) end i observationsgruppen.
English: The percentage of patients reporting ADRs upon re-treatment with further courses of MabThera was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
Danish: Andelen af patienter, der rapporterede bivirkninger efter genbehandling med flere MabThera serier var sammenlignelig med andelen af patienter, der rapporterede bivirkninger efter induktionsbehandling (alle bivirkninger og bivirkninger af grad 3/4)
English: MabThera is associated with infusion/administration-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Danish: MabThera er forbundet med infusions-/administrationsrelaterede reaktioner, der kan være relateret til frigivelse af cytokiner og/eller andre kemiske mediatorer.
English: 48-months p = 0.0096
Danish: 48-måneder p=0,0096
English: Colourless type I glass vial with butyl rubber stopper with aluminium over seal and a blue plastic flip-off disk, containing 1600 mg/13.4 mL of rituximab.
Danish: Hætteglas, af farveløst type I glas, med butylgummiprop med aluminiumsforsegling og blåt vipbart plastiklåg, indeholdende 1600 mg/13,4 ml rituximab.
English: For information related to the other indications, please refer to the SmPC of MabThera intravenous formulation.
Danish: For information vedrørende andre indikationer henvises til produktresuméet for MabThera intravenøs formulering.
English: • This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes.
Danish: • Non-Hodgkin-lymfom er en sygdom i lymfesystemet (en del af immunsystemet), der påvirker de hvide blodlegemer, der kaldes B-lymfocytter.
English: The recommended dose of MabThera subcutaneous formulation used for adult patients is a subcutaneous injection at a fixed dose of 1600 mg irrespective of the patient's body surface area.
Danish: Anbefalet dosis af MabThera subkutan formulering til voksne er en subkutan injektion i fast dosis på 1600 mg, uafhængigt af patientens legemsoverfladeareal.
English: respiratory failure4,
Danish: respirationssvigt4
English: The benefit of MabThera maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (Table 9).
Danish: Fordelen ved MabThera vedligeholdelsesbehandling blev bekræftet af alle undergruppeanalyser, uafhængigt af induktionsbehandlingen (CHOP eller R-CHOP) eller graden af respons på induktionsbehandlingen (CR eller PR) (tabel 9).
English: This medicine contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial and 11.5 mmol (or 263.2 mg) per 50 mL vial.
Danish: Denne medicin indeholder 2,3 mmol (eller 52,6 mg) natrium pr. 10 ml hætteglas og 11,5 mmol (eller 263,2 mg) natrium pr. 50 ml hætteglas.
English: The information provided in the section 4.4 pertains to the use of MabThera subcutaneous formulation in the approved indications Treatment of non Hodgkin lymphoma (strength 1400 mg) and Treatment of CLL (strength 1600 mg).
Danish: 4.4 vedrører brug af MabThera subkutan formulering i de godkendte indikationer Behandling af non-Hodgkin-lymfom (styrke 1400 mg) og Behandling af kronisk lymfatisk leukæmi (CLL) (styrke 1600 mg).
English: MabThera is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Danish: MabThera leveres i sterile, pyrogenfri hætteglas uden konserveringsmiddel til engangsbrug.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,400 mg/11.7 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1400 mg/11,7 ml
English: If you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
Danish: Hvis du har reumatoid artrit, granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris, fortæl da også din læge
English: Before starting MabThera subcutaneous injections, all patients must always receive beforehand, a full dose of MabThera by intravenous infusion, using MabThera intravenous formulation (see section 4.4).
Danish: Inden subkutane injektioner med MabThera påbegyndes, skal alle patienter altid forinden have modtaget en fuld dosis MabThera som intravenøs infusion, med MabThera intravenøs formulering (se pkt.
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: Diluted medicinal product
Danish: Fortyndet opløsning af lægemidlet
English: The geometric mean tmax in the MabThera subcutaneous group was approximately 3 days as compared to the tmax occuring at or close to the end of the infusion for the MabThera intravenous group.
Danish: Det geometriske gennemsnits Tmax for MabThera i subkutan formulering var ca. 3 dage sammenlignet med, det Tmax, der opstod ved eller tæt på slutningen af MabThera infusion, intravenøs formulering.
English: The Summary of Product Characteristics (SmPC) of MabThera 100 mg and 500 mg concentrate for solution for infusion should be referred to for information on dosing instructions and method of administration.
Danish: Der henvises til produktresumé for MabThera 100 mg og 500 mg koncentrat til opløsning til infusion for information vedrørende dosering og administration.
English: Limited experience with doses higher than the approved dose of intravenous MabThera formulation is available from clinical trials in humans.
Danish: Der er begrænset erfaring fra kliniske studier hos mennesker med doser over den godkendte dosis af intravenøre MabThera-formuleringer.
English: In a randomised trial, patients with rheumatoid arthritis treated with MabThera and methotrexate had comparable response rates to tetanus recall antigen (39% vs. 42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs. 82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs. 93%), when given 6 months after MabThera as compared to patients only receiving methotrexate.
Danish: Responsraterne var sammenlignelige ved vaccination med tetanus recall antigen (39 % versus 42 %), der var reduceret respons over for pneumokok polysaccharid vaccine (43 % versus 82 % over for mindst to pneumokokantistof serotyper) og over for KLH neoantigen (47 % versus 93 %), når vaccinationen blev givet 6 måneder efter MabThera-behandling.
English: The recommended dose of MabThera subcutaneous formulation used for adult patients is a subcutaneous injection at a fixed dose of 1400 mg irrespective of the patient's body surface area.
Danish: Anbefalet dosis af MabThera subkutan formulering til voksne er en subkutan injektion i fast dosis på 1400 mg, uafhængigt af patientens legemsoverfladeareal.
English: The use of MabThera subcutaneous formulation as monotherapy in patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy cannot be recommended as the safety of the once weekly subcutaneous administration has not been established.
Danish: Brugen af MabThera subkutan formulering som monoterapi kan ikke anbefales hos patienter med stadium III-IV follikulært lymfom, som er resistente over for kemoterapi eller som oplever 2. eller efterfølgende recidiv efter kemoterapi, da sikkerheden af én gang ugentlig subkutan administration, endnu ikke er klarlagt.
English: In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or MabThera in combination with FC (R-FC).
Danish: I to åbne, randomiserede studier blev 817 tidligere ubehandlede patienter og 552 patienter med relaps/refraktær CLL randomiseret til enten FC-kemoterapi (fludarabin 25 mg/m2, cyclophosphamid 250 mg/m2, på dag 1-3) hver 4. uge i 6 serier eller MabThera i kombination med FC (R-FC).
English: When you are treated with MabThera in combination with chemotherapy, you will receive a MabThera infusion on day 0 of cycle 1, then subcutaneous injections on day 1 of each subsequent cycle.
Danish: Når du behandles med MabThera i kombination med kemoterapi, vil du få en MabThera intravenøs infusion på dag 0 i behandlingsserie 1.
English: The 1400 mg strength is intended for subcutaneous use in non Hodgkin lymphoma (NHL) only.
Danish: Styrken på 1400 mg er kun beregnet til subkutan brug hos patienter med nonHodgkin-lymfom.
English: System Organ Class Adverse drug reaction1
Danish: Systemorganklasser Bivirkninger1
English: In patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy.
Danish: Hos patienter med non-Hodgkin-lymfom og CLL bør det overvejes at give præmedicinering med glukokortikoider, hvis MabThera ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
English: MabThera should be administered on day 1 of each chemotherapy cycle, after administration of the glucocorticoid component of the chemotherapy if applicable.
Danish: MabThera bør gives på dag 1 i hver kemoterapiserie, efter administration af glukokortikoidkomponenten, hvis det anvendes.
English: Premedication consisting of an analgesic/antipyretic and an antihistamine should always be administered before each dose of MabThera subcutaneous formulation.
Danish: Der bør altid gives præmedicin bestående af et analgetisk/anti-pyretisk middel samt et antihistamin inden hver subkutane administration af MabThera.
English: Similarly, for subjects in the high BSA tritile, Ctrough values were the same for the intravenous and subcutaneous regimens.
Danish: Ligeledes, for patienter, der har et højt BSA, var Ctrough værdien ens for intravenøs dosering og subkutan dosering.
English: Information to appear on Peel-off sticker
Danish: Information som skal fremgå på et aftageligt klistermærke Lot
English: Colourless type I glass vial with butyl rubber stopper with aluminium over seal and a pink plastic flip-off disk, containing 1400 mg/11.7 mL of rituximab.
Danish: Hætteglas, af farveløst type I glas, med butylgummiprop med aluminiumsforsegling og lyserødt vipbart plastiklåg, indeholdende 1400 mg/11,7 ml rituximab.
English: MabThera was administered on the first day of the treatment cycle.
Danish: MabThera blev givet på den første dag i behandlingsserien.
English: Administration related reactions have been observed in up to 50% of patients treated with MabThera subcutaneous formulation in clinical trials.
Danish: Der er i kliniske studier set administrationsrelaterede reaktioner hos op til 50 % af patienter behandlet med MabThera subkutan formulering.
English: Relapsing n=51
Danish: Patienter med recidiv n=51
English: This is because in a few cases, MabThera could cause hepatitis B to become active again, which can be fatal in very rare cases.
Danish: Det er vigtigt, fordi MabThera i enkelte tilfælde har forårsaget, at en tidligere leverbetændelse (hepatitis B) er blevet aktiv igen.
English: Very rare cases of progressive multifocal leukoencephalopathy (PML) have been reported during post-marketing use of MabThera in NHL and CLL (see section 4.8).
Danish: Der er i meget sjældne tilfælde blevet rapporteret om tilfælde af progressiv multifokal leukoencefalopati (PML) efter markedsføring af MabThera hos patienter med NHL og CLL (se pkt.
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Danish: Den samlede responsrate efter behandlingsserie 8 var 76,2 % i R-CHOP-gruppen sammenlignet med 62,4 % i CHOP-gruppen (p=0,0028).
English: SC for Chronic Lymphocytic Leukaemia
Danish: SC til kronisk lymfatisk leukemi
English: If patients were not able to receive one full MabThera intravenous infusion dose prior to the switch, they should continue the subsequent cycles with MabThera intravenous formulation until a full intravenous dose is successfully administered.
Danish: Hvis patienten ikke kan modtage en fuld dosis MabThera intravenøs infusion inden skifte til subkutan injektion, skal efterfølgende behandlingsserier gives som MabThera intravenøs formulering, indtil det lykkes at give en fuld intravenøs dosis.
English: c) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Danish: Hvis du behandles for granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium.
Danish: Hvert 50 ml hætteglas indeholder 11,5 mmol (263,2 mg) natrium.
English: Table 5 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP R-CHOP p-value Risk Reduction1)
Danish: Tabel 5 Induktionsfase: oversigt over effektresultater for CHOP versus R-CHOP (31 måneders median observationstid)
English: In a multi-centre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of MabThera, were re-treated with 375 mg/m2 of MabThera as intravenous infusion weekly for four doses.
Danish: I et enkelt-arms multicenterstudie blev 58 patienter med recidiveret elle kemoterapi-resistent lavmalignt eller follikulært B-celle NHL, som havde opnået et objektivt klinisk respons efter en tidligere serie med MabThera, genbehandlet med 375 mg/m2 MabThera som intravenøs infusion ugentligt i fire doser.
English: MabThera intravenous
Danish: MabThera intravenøs
English: In addition, other serious viral infections either new, reactivated or exacerbated, some of which were fatal, have been reported with MabThera treatment.
Danish: Derudover er der rapporteret andre alvorlige virusinfektioner under behandling med MabThera, enten nye, reaktiverede eller recidiverede.
English: Physicians should exercise caution when considering the use of MabThera in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection, e.g. hypogammaglobulinaemia (see section 4.8).
Danish: Læger bør udvise forsigtighed, når anvendelse af MabThera overvejes til patienter med recidiverende eller kroniske infektioner i anamnesen eller med underliggende sygdomme, som yderligere kan gøre patienterne disponerede for alvorlige infektioner, f.eks. hypogammaglobulinæmi (se pkt.
English: Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischemia) in 3% of patients treated with MabThera compared to <1% on observation.
Danish: Kardielle bivirkninger rapporteredes som alvorlige bivirkninger (inklusive atrieflimren, myokardieinfarkt, venstre ventrikelsvigt, myokardieiskæmi) hos 3 % af patienterne behandlet med MabThera sammenlignet med <1 % under observation.
English: Premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy.
Danish: Præmedicinering med glukokortikoid bør overvejes, hvis MabThera ikke gives i kombination med glukokortikoidholdig kemoterapi.
English: Mean change from baseline: Modified total sharp score
Danish: Modificeret Total Sharp Score Erosionsscore
English: • MabThera subcutaneous (n= 88); 1st cycle of MabThera intravenous 375 mg/m2 in combination with chemotherapy plus subsequent cycles (2-6) of MabThera subcutaneous 1600mg in combination with chemotherapy.
Danish: • MabThera subkutan (n = 88): 1. serie af MabThera indgivet intravenøs 375 mg/m2 i kombination med kemoterapi samt efterfølgende serier (2-6) af MabThera indgivet subkutant 1600 mg i kombination med kemoterapi.
English: MabThera is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Danish: MabThera er forbundet med infusionsrelaterede reaktioner, som kan være relaterede til frigivelse af cytokiner og/eller andre kemiske mediatorer.
English: Local cutaneous reactions of any grade in the MabThera subcutaneous arm were most common during the first subcutaneous cycle (Cycle 2), followed by the second, and the incidence decreased with subsequent injections.
Danish: I armen med subkutan MabThera var lokale hudreaktioner af enhver grad hyppigst i den første subkutane serie (2. serie), efterfulgt af den anden subkutane serie.