FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep this card with you for 2 years after your last dose of Rixathon.
Danish: Opbevar dette kort på dig i 2 år efter, at du har fået den sidste Rixathon-dosis.
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: Therefore patients with a history of cardiac disease should be monitored closely (see Infusion-related reactions, above).
Danish: Derfor bør patienter med hjertelidelse i anamnesen monitoreres nøje (se afsnittet Infusionsrelaterede reaktioner ovenfor).
English: Laboratory evaluations
Danish: Laboratorieevalueringer
English: Rituximab may have a minor influence on the ability to drive and use machines.
Danish: Rituximab kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Hepatitis B infections
Danish: Hepatitis B-infektioner
English: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to Rixathon therapy.
Danish: Lægen bør gennemgå patientens vaccinationsstatus og følge gældende vaccinationsvejledninger inden igangsætning af Rixathon behandling.
English: Rheumatoid arthritis is a disease of the joints.
Danish: Reumatoid artrit er en sygdom i leddene.
English: • Cardiovascular events, see section 4.4.
Danish: • Kardiovaskulære hændelser, se pkt.
English: No pharmacokinetic data are available in patients with hepatic or renal impairment.
Danish: Der er ingen tilgængelige farmakokinetiske data om patienter med lever- eller nyreinsufficiens.
English: The incidence of infusionrelated symptoms decreases substantially with subsequent infusions and is less than 1% after eight doses of rituximab.
Danish: Incidensen af infusionsrelaterede symptomer aftager væsentligt med de følgende infusioner og er under 1 % efter 8 doser rituximab.
English: However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breast-feed while treated with Rixathon and for 12 months following Rixathon 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 Rixathon og i 12 måneder efter afsluttet Rixathon behandling.
English: This is because some people have a fall in their blood pressure while they are being given Rixathon.
Danish: Nogle har oplevet, at blodtrykket faldt, mens de fik Rixathon
English: All physicians who are expected to prescribe Rixathon for NHL/CLL are provided with the following to reduce the risk of administration route errors: - Product information - HCP Alert card addressing the correct use of Rixathon
Danish: Alle læger, som kan forventes at udskrive Rixathon mod NHL/CLL, har modtaget følgende med henblik på at reducere risikoen for forkerte administrationsveje: - Produktinformation - Sundhedspersonalekort vedrørende korrekt anvendelse af Rixathon
English: An analysis of overall survival confirmed the significant benefit of rituximab maintenance over observation (p=0.0039 log-rank test).
Danish: En analyse af den samlede overlevelse bekræftede den signifikante fordel af rituximab vedligeholdelse fremfor observation (p=0,0039 log-rank test).
English: If you are having Rixathon with other medicines, some of the side effects you may get may be due to the other medicines.
Danish: Hvis du får Rixathon sammen med anden medicin, kan nogle bivirkninger være forårsaget af den anden medicin.
English: The cells that are affected by Rixathon help to fight infection and you should wait until the infection has passed before you are given Rixathon.
Danish: Cellerne, der påvirkes af Rixathon hjælper med at bekæmpe infektioner, og du bør vente med behandling med Rixathon, indtil infektionen er forsvundet.
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, inklusive GPA og MPA.
English: Rixathon may also cause changes in laboratory tests carried out by your doctor.
Danish: Rixathon kan også ændre resultaterne på de blodprøver, som lægen har bestilt.
English: Overall, 4% of patients in the rituximab arm experienced adverse events leading to discontinuation.
Danish: Samlet set oplevede 4 % af patienterne i rituximab-armen bivirkninger, der ledte til seponering.
English: • If you respond well to treatment, you may be given Rixathon as a maintenance treatment every 2 or 3 months for two years.
Danish: • Hvis medicinen virker godt hos dig, kan du få Rixathon som vedligeholdelsesbehandling hver 2. eller 3. måned i op til 2 år.
English: Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle and any subsequent cycles if the lymphocyte count is still > 25 x 109/L.
Danish: Det bør overvejes at give disse patienter første infusion med nedsat infusionshastighed eller at fordele dosis over to dage i første serie og hver af de efterfølgende serier, hvis lymfocyttallet stadig er > 25 x 109/l.
English: In placebo-controlled periods of clinical trials, 0.94% (13/1,382) of rituximab treated patients and 0.27% (2/731) of placebo patients developed severe neutropenia.
Danish: I placebokontrollerede perioder af kliniske studier udviklede 0,94 % (13/1.382) af rituximabbehandlede patienter og 0,27 % (2/731) af placebo-behandlede patienter svær neutropeni.
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Rixathon to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Danish: For CLL-patienter, hvis lymfocyttal er > 25 x 109/l, anbefales det at administrere 100 mg prednison/prednisolon intravenøst kort før infusionen med Rixathon for at reducere hastigheden og sværhedsgraden af akutte infusionsreaktioner og/eller cytokinfrigivelsessyndrom.
English: Dyspnoea Epistaxis Nasal congestion
Danish: Epistaxis Nasal kongestion
English: Rixathon is for intravenous use.
Danish: Rixathon er til intravenøs anvendelse.
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximabtreated patients vs 5% for azathioprine treated patients.
Danish: I det kliniske studie med vedligeholdelsesbehandling var hyppigheden af alle grader neutropeni 0 % for rituximab-behandlede patienter vs 5 % for azathioprin-behandlede patienter.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following Rixathon treatment, as appropriate according to local clinical practice guidelines.
Danish: Profylakse mod Pneumocystis jiroveci-pneumoni (PCP) anbefales til patienter med GPA/MPA eller PV under og efter behandling med Rixathon i det omfang, det er relevant i henhold til lokale kliniske retningslinjer.
English: When you are treated with Rixathon in combination with chemotherapy, you will receive Rixathon infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
Danish: Hvis du behandles med Rixathon i kombination med kemoterapi, vil du få en infusion med Rixathon på dag 0 i serie 1 og derefter på dag 1 i hver af i alt 6 serier.
English: The most frequently reported serious infection in the rituximab group was pneumonia at a frequency of 4%.
Danish: Den hyppigst indberettede alvorlige infektion i rituximabgruppen var pneumoni med en forekomst på 4 %.
English: 10.49 years
Danish: 10,49 år
English: Median TTF: 2.6 years Not reached p < 0.001
Danish: Median TTF: 2,6 år Ikke opnået p < 0,001
English: The frequencies of ADRs reported with rituximab alone or in combination with chemotherapy are summarised in Table 1.
Danish: Hyppigheden af de bivirkninger, som er rapporteret ved rituximab alene eller i kombination med kemoterapi, er sammenfattet i tabel 1.
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 rituximab 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 rituximab i kombination med methotrexat, viste et øget respons sammenlignet med patienter, som var negative for begge.
English: Clear, colourless to slightly yellowish liquid.
Danish: Klar, farveløs til let gullig væske.
English: Regular full blood counts, including neutrophil and platelet counts, should be performed during Rixathon therapy.
Danish: Regelmæssige, fuldstændige blodtællinger, inklusive neutrofil-og trombocyttællinger, bør udføres under Rixathon-behandling.
English: 150 patients originally randomised to placebo + MTX in Trial 1 received at least one course of RTX + MTX by one year * p < 0.05, ** p < 0.001.
Danish: 150 patienter, som oprindeligt var randomiseret til placebo + MTX i studie 1, fik mindst en behandlingsserie af rituximab + MTX ved 1 år * p < 0,05, ** p < 0,001.
English: This is mostly accounted for by IRRs (most frequent during the first treatment course), RA exacerbation and infections, all of which were more frequent in the first 6 months of treatment.
Danish: Dette kan hovedsageligt tilskrives infusionsrelaterede reaktioner (hyppigst under første behandlingsserie), reumatoid artrit-eksacerbation og infektioner, som alle var hyppigere i de første 6 måneder af behandlingen.
English: In the relapsed/refractory CLL study grade 3/4 thrombocytopenia was reported in 11% of patients in the R-FC group compared to 9% of patients in the FC group.
Danish: I relaps/refraktær CLL-studiet blev trombocytopeni af grad 3/4 rapporteret hos 11 % af patienterne i R-FC-gruppen sammenlignet med 9 % af patienterne i FC-gruppen.
English: The HCP educational leaflets and the Patient educational leaflet will be agreed with the National Competent Authorities prior to distribution.
Danish: Undervisningsbrochuren til sundhedspersonalet og undervisningsbrochuren til patienter godkendes af den nationale sundhedsmyndighed, inden materialerne distribueres.
English: Rituximab maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, >= 60 years), FLIPI score (<=1, 2 or >= 3), induction therapy (R-CHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
Danish: Rituximab-vedligeholdelsesbehandling gav konsekvent fordel i alle testede prædefinerede undergrupper: Køn (mand, kvinde), alder (< 60 år, ≥ 60 år), FLIPI-score (≤ 1, 2 eller ≥ 3), induktionsbehandling (R-CHOP, R-CVP eller R-FCM) og uanset kvaliteten af respons på induktionsbehandling (CR, CRu eller PR).
English: Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma or chronic lymphocytic leukaemia
Danish: Andre bivirkninger omfatter: a) Hvis du behandles for non-Hodgkin-lymfom eller kronisk lymfatisk leukæmi
English: If you respond well to treatment, you may be given Rixathon as a maintenance treatment.
Danish: Hvis du reagerer godt på behandlingen, kan du få Rixathon som vedligeholdelsesbehandling.
English: PML, reactivation of hepatitis B
Danish: PML, reaktiverin g af hepatitis B
English: Following induction of remission with Rixathon, maintenance treatment should be initiated no sooner than 16 weeks after the last rituximab infusion.
Danish: Efter induktion af remission med Rixathon skal vedligeholdelsesbehandling initieres tidligst 16 uger efter sidste rituximab-infusion.
English: Patients treated with Rixathon may receive non-live vaccinations.
Danish: som behandles med Rixathon, kan vaccineres med ikke-levende vacciner.
English: Rixathon should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Danish: Rixathon bør gives på dag 1 i hver kemoterapiserie, efter intravenøs indgift af glukokortikoidkomponenten, hvis det anvendes.
English: Patients with active hepatitis B disease should not be treated with Rixathon.
Danish: Patienter med aktiv hepatitis B-sygdom bør ikke behandles med Rixathon.
English: In the PV population, 5 (13%) patients in the rituximab group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the rituximab 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 rituximab-gruppen og 3 (8 %) patienter i standarddosis prednison-gruppen moderat sygdom, og 33 (87 %) patienter i rituximab-gruppen og 33 (92 %) patienter i standarddosis prednison-gruppen havde svær sygdom i henhold til sygdomssværhedsgrad defineret ved Harman's kriterier.
English: • pain in the muscles
Danish: • smerter i musklerne
English: CLL affects a particular lymphocyte, the B cell, which originates from the bone marrow and develops in the lymph nodes.
Danish: CLL påvirker en bestemt lymfocyt, nemlig B-cellen, som findes i knoglemarven og dannes i lymfeknuderne.
English: Three patients (8%) in the rituximab 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 rituximab-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: Rarely Rixathon can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Danish: Rixathon har i sjældne tilfælde forårsaget en alvorlig hjerneinfektion, som kaldes ”Progressiv multifokal leukoencefalopati” (PML).
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 gentagne infusioner (< 4 %).
English: Table 18 Percentage of PV patients who achieved complete remission off corticosteroid therapy for two months or more at month 24 (Intent-to-Treat Population - PV)
Danish: Tabel 18 Procentdel af patienter med PV, som opnåede fuldstændig remission uden kortikoid-behandling i to eller flere måneder ved måned 24 (ITT-population - PV)
English: Therefore vaccination with live virus vaccines is not recommended whilst on Rixathon or whilst peripherally B cell depleted.
Danish: Derfor kan vaccination med levende, virale vacciner ikke anbefales samtidig med Rixathon behandling, eller mens der er perifer B-celle depletion.
English: A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to rituximab 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 rituximab-vedligeholdelsesbehandling (n=167) eller observation (n=167).
English: If patients did not experience a serious infusion related reaction with their first or subsequent infusions of a dose of 1,000 mg Rixathon 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 Rixathon-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: Cyclophosphamide (n=98)
Danish: Cyclophosphamid (n=98)
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: Talk to your doctor, pharmacist or nurse before you are given Rixathon if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, inden du får Rixathon, hvis:
English: Rixathon 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: Rixathon 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: If you can get pregnant, you and your partner must use an effective method of contraception while using Rixathon.
Danish: Hvis du er i den fødedygtige alder, skal du og din partner bruge sikker prævention, mens du er i behandling med Rixathon.
English: % HAQ-DI MCID Mean change in FACIT-T
Danish: Gennemsnitsændring i HAQ-DI % HAQ-DI MCID Gennemsnitsændring i FACIT-T
English: Patients received 2 x 1,000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10 - 25 mg/week).
Danish: Patienterne fik 2 x 1.000 mg rituximab med to ugers interval, derudover methotrexat (10-25 mg/uge).
English: Repeated treatment courses with Rixathon are possible.
Danish: Gentagne behandlingsforløb med Rixathon er mulige.
English: The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for rituximab (see section 4.4).
Danish: Sikkerhedsinformationen, som er samlet efter markedsføring, afspejler den forventede bivirkningsprofil, dvs. den som blev set i kliniske studier med rituximab (se pkt.
English: • allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
Danish: • allergiske reaktioner, som højst sandsynligt forekommer under infusion, men kan forekomme i op til 24 timer efter infusion
English: Rituximab was administered as two intravenous infusions separated by an interval of 15 days.
Danish: Rituximab blev administreret som to i.v.-infusioner med et interval på 15 dage.
English: • A complex of symptoms occurring within a few weeks of an infusion of rituximab 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 rituximab, herunder allergiske reaktioner, såsom udslæt, kløe, ledsmerter, hævede lymfekirtler og feber
English: The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3 - 15).
Danish: Hyppigheden af alvorlige kardielle bivirkninger var 2,1 pr. 100 patientår (95 % konfidensinterval 3-15).
English: Rituximab 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: Rituximab-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: Rixathon is used for the treatment of rheumatoid arthritis.
Danish: Rixathon anvendes til behandling af reumatoid artrit.
English: The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p < 0.0001 Chi-Square test) in the R-CVP group (80.9%) than the CVP group (57.2%).
Danish: Andelen af patienter med tumorrespons (CR, Cru, PR) var signifikant højere (p < 0,0001 chi square test) i R-CVP-gruppen (80,9 %) end i CVP-gruppen (57,2 %).
English: Trials of rituximab 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 rituximab 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: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Rixathon.
Danish: Der bør altid gives præmedicin bestående af et anti-pyretisk lægemiddel samt et antihistamin, f.eks. paracetamol og diphenhydramin, inden hver Rixathon-administration.
English: • Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue,
Danish: • allergiske reaktioner herunder hvæsende vejrtrækning og åndenød, hævelse af ansigt og tunge,
English: Rixathon should be used in combination with CHOP chemotherapy.
Danish: Rixathon bør anvendes i kombination med CHOP kemoterapi.
English: No dose reductions of Rixathon are recommended.
Danish: Der er ingen anbefalinger vedrørende dosisreduktion af Rixathon.
English: • Infections such as pneumonia (bacterial)
Danish: • infektioner som f.eks. lungebetændelse (bakteriel)
English: Measure blood neutrophils prior to each course of Rixathon, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Danish: Neutrofiltælling bør foretages inden hver Rixathon behandlingsserie og regelmæssigt op til 6 måneder efter afsluttet behandling, samt ved tegn på infektion (se pkt.
English: Following induction of remission with other standard of care immunosuppressants, Rixathon 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 Rixathon vedligeholdelsesbehandling initieres i løbet af en 4 ugers periode efter opnåelse af sygdomsremission.