FrancophonIA/ELRC3.0 huggingface dataset:
English: Contraindications for use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Danish: Kontraindikationer for anvendelse til non-Hodgkin-lymfom og kronisk lymfatisk leukæmi Overfølsomhed over for det aktive stof, murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
English: There was no apparent negative impact of the presence of ADA on safety or efficacy in the induction of remission trial.
Danish: Der var tilsyneladende ingen negativ påvirkning af tilstedeværelsen af ADA på sikkerheden eller effekten i studiet med induktion til remission.
English: In patients treated with rituximab, the occurrence of pre-existing ischemic cardiac conditions becoming symptomatic, such as angina pectoris, has been observed, as well as atrial fibrillation and flutter.
Danish: Hos patienter der er blevet behandlet med rituximab, er der observeret udvikling af symptomer på tidligere eksisterende iskæmiske hjertelidelser, såsom angina pectoris, ligesom atriel flimren og flagren.
English: Ear and labyrinth disorders tinnitus, ear pain hearing loss5
Danish: Øre og labyrint tinnitus, øresmerter høretab5
English: The benefit of rituximab 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 rituximab 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: 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: respiratory failure4
Danish: respirationssvigt4
English: Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported.
Danish: Under infusionen blev der rapporteret om arytmier af grad 3 eller 4 (herunder ventrikulær og supraventrikulær takykardi) og angina pectoris.
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: Very rarely, severe blistering skin conditions that can be life-threatening may occur.
Danish: Meget sjældent kan der forekomme alvorlige, eventuelt livstruende hudsygdomme med blærer.
English: lung infiltration
Danish: lungeinfiltrater
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Danish: Patientkortet indeholder vigtige oplysninger om sikkerhed for patienterne angående potentiel øget risiko for infektioner, herunder progressiv multifokal leukoencefalopati (PML).
English: Rituximab mean clearance and volume of distribution were 0.313 L/day (range, 0.116 to 0.726 L/day) and 4.50 L (range 2.25 to 7.39 L) respectively.
Danish: Gennemsnitlig clearance og fordelingsvolumen for rituximab var henholdsvis 0,313 l/dag (0,116-0,726 l/dag) og 4,50 l (2,25-7,39 l).
English: Aseptically withdraw the necessary amount of Ritemvia, 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 Ritemvia 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: Patients could receive 1000 mg IV at the time of relapse (see section 5.1).
Danish: Patienter kunne få 1.000 mg intravenøst på tidspunktet for recidiv (se pkt.
English: • blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes
Danish: • blodprop, nedsat produktion og hurtigere ødelæggelse af røde blodlegemer (aplastisk hæmolytisk anæmi), hævede eller forstørrede lymfekirtler
English: Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of IRRs (see sections 4.2 and 4.4).
Danish: Præmedicinering med intravenøs glukokortikoid reducerede forekomsten og sværhedsgraden af IRR signifikant (se pkt.
English: In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
Danish: I relaps/refraktær-studiet var medianen for progressionsfri overlevelse (det primære endepunkt) 30,6 måneder i R-FC-gruppen og 20,6 måneder i FC-gruppen (p = 0,0002, log-rank test).
English: Pemphigus vulgaris is an autoimmune condition that causes painful blisters on the skin and lining of the mouth, nose, throat and genitals.
Danish: Pemfigus vulgaris er en autoimmun sygdom, der forårsager smertefulde blærer på huden og mundens, næsens, halsens og kønsorganernes slimhinder.
English: If you are being treated for non-Hodgkin's Lymphoma
Danish: Hvis du behandles for non-Hodgkin-lymfom
English: Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Danish: Rituximab bør ikke administreres til patienter med en aktiv, alvorlig infektion (for eksempel tuberkulose, sepsis og opportunistiske infektioner, se pkt.
English: Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Danish: Ritemvia vedligeholdelsesbehandling er indiceret til behandling af follikulært lymfom hos patienter, der responderer på induktionsbehandling.
English: A total of 19/34 (56%) patients with PV, who were treated with rituximab, tested positive for ADA antibodies by 18 months.
Danish: I alt 19 ud af 34 (56 %) patienter med PV, som blev behandlet med rituximab, testede positive for ADA antistoffer ved måned 18.
English: • low numbers of platelets in the blood
Danish: • lavt antal blodplader
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: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).
Danish: Alvorlige infektioner, herunder dødelige, kan forekomme under behandlingen med rituximab (se pkt.
English: • Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any
Danish: • Information om symptomer på infektioner, især PML, og nødvendigheden af at kontakte deres læge straks, hvis de får nogle symptomer
English: • tightening of the muscles in the airways which causes wheezing (bronchospasm),
Danish: • sammensnøring af musklerne i luftvejene, som forårsager hvæsende vejrtrækning
English: • The active ingredient in Ritemvia is called rituximab.
Danish: • Aktivt stof i Ritemvia: Rituximab.
English: Symptoms of infusion-related reactions were similar in type and severity to those seen in RA and GPA/MPA patients.
Danish: Symptomerne på infusionsrelaterede reaktioner var lignende i type og sværhedsgrad med dem set hos patienter med reumatoid artrit og GPA/MPA.
English: Safety and efficacy of Ritemvia have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Danish: Sikkerhed og effekt af Ritemvia er ikke påvist i kombination med andre kemoterapiregimer til behandling af diffust storcellet B-celle non-Hodgkin-lymfom.
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: 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: In a further clinical study, a total of 57 severe, active GPA and MPA patients in disease remission were treated with rituximab for the maintenance of remission (see section 5.1).
Danish: I endnu et klinisk studie blev i alt 57 patienter med svær, aktiv GPA og MPA i sygdomsremission behandlet med rituximab for vedligeholdelse af remission (se pkt.
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: 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 rituximab (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 rituximab sammenlignet med patienter behandlet med standarddosis prednison over behandlingsperioden på 24 måneder (figur 4).
English: Progression-free survival (PFS) Overall survival
Danish: Progressionsfri overlevelse (PFS) Samlet overlevelse
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 rituximab-gruppen var pneumoni med en forekomst på 4 %.
English: Ritemvia should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Danish: Ritemvia skal administreres som to 500 mg intravenøse infusioner, med to ugers mellemrum, efterfulgt af en 500 mg intravenøs infusion hver 6. måned.
English: There was no apparent negative impact of the presence of ADA on safety or efficacy in the maintenance therapy clinical trial.
Danish: Der var tilsyneladende ingen negativ indvirkning ved tilstedeværelsen af ADA på sikkerheden eller effekten i det kliniske studie med vedligeholdelsesbehandling.
English: In patients where the treatment is working, Ritemvia may be continued for 2 years after completing the initial treatment.
Danish: Hvis behandlingen virker, kan Ritemvia fortsættes i 2 år efter, den første behandling er givet.
English: Therefore, patients with a history of cardiac disease and/or cardiotoxic chemotherapy should be monitored closely.
Danish: Derfor bør patienter med hjertelidelse og/eller tidligere kardiotoksisk kemoterapi i anamnesen monitoreres nøje.
English: The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test).
Danish: Den mediane responsvarighed var 37,7 måneder i R-CVP-gruppen, og den var 13,5 måneder i CVP-gruppen (p < 0,0001), log rank test).
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen, apotekspersonalet eller sundhedspersonalet om al medicin du tager i øjeblikket, har taget for nyligt eller planlægger at tage.
English: The prepared infusion solution of rituximab in 5% glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
Danish: Den tilberedte rituximab infusionsopløsning er i 5 % D-glukose opløsning fysisk og kemisk stabil i 24 timer ved 2 °C - 8 °C og efterfølgende 12 timer ved stuetemperatur (ikke over 30 °C).
English: • hives, increased sweating, night sweats
Danish: • nældefeber, øget svedtendens, nattesved
English: It should not be administered as an intravenous push or bolus.
Danish: Den færdige infusionsopløsning må ikke administreres som hurtig intravenøs injektion eller bolus.
English: Significant difference from placebo + MTX at the primary time point: ***p ≤ 0.0001
Danish: † resultat ved uge 24 Signifikant forskel fra placebo + MTX ved det primære tidspunkt: ***p ≤ 0,0001
English: No serious IRRs were observed.
Danish: Ingen alvorlige infusionsrelaterede reaktioner blev observeret.
English: Patient subpopulations - rituximab monotherapy
Danish: Specielle populationer - rituximab monoterapi
English: Rituximab 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: Rituximab 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: In patients with non-Hodgkin's lymphoma, premedication with glucocorticoids should be considered if Ritemvia is not given in combination with glucocorticoid-containing chemotherapy.
Danish: Hos patienter med non-Hodgkin-lymfom bør det overvejes at give præmedicinering med glukokortikoider, hvis Ritemvia ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
English: The efficacy and safety of rituximab 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, multicentre trial (Trial 1).
Danish: Effekt og sikkerhed af rituximab 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: Risk reduction
Danish: Risiko reduktion
English: This is equivalent to 13.2% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 13,2% af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: Limited experience with doses higher than the approved dose of intravenous rituximab 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 intravenøse rituximab-formuleringer.
English: C.A.
Danish: n.a.
English: 4.06 years
Danish: 4,06 år
English: Among the 3189 patients treated with rituximab, 1,135 (36%) experienced at least one IRR with 733/3,189 (23%) of patients experiencing an IRR following first infusion of the first exposure to rituximab.
Danish: Blandt de 3.189 patienter, som blev behandlet med rituximab, fik 1.135 (36 %) mindst en IRR, og 733/3.189 (23 %) af patienterne fik en IRR efter første infusion i den første rituximab-behandling.
English: Should non-live vaccinations be required whilst receiving rituximab therapy, these should be completed at least 4 weeks prior to commencing the next course of rituximab.
Danish: Hvis vaccination med ikke levende vacciner er nødvendig samtidig med behandling med rituximab, bør vaccinationerne være gennemført mindst 4 uger inden næste behandling med rituximab.
English: In case of such an event with a suspected relationship to rituximab, treatment should be permanently discontinued.
Danish: Hvis en sådan bivirkning skulle opstå med formodet relation til rituximab, skal behandlingen seponeres permanent.
English: In general toxicity studies in cynomolgus monkeys no deleterious effects on reproductive organs in males or females were observed.
Danish: I generelle toksicitetsstudier med cynomolgusaber sås ingen negativ effekt på reproduktionsorganer hos hanner og hunner.
English: Elderly No dose adjustment is required in elderly patients (aged >65 years).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter (alder > 65 år).
English: The most frequent ADRs following receipt of rituximab in clinical studies were IRRs (refer to Table 2).
Danish: Den hyppigste bivirkning efter administration af rituximab i kliniske studier var infusionsrelaterede reaktioner (IRR) (se tabel 2).
English: confidence interval; FU: follow-up; TNLT: time to next anti-lymphoma treatment; TNCT: time to next chemotherapy treatment; NR: not reached at time of clinical cut-off.
Danish: KI: konfidensinterval; TNLT: Tid til næste anti-lymfom-behandling; TNCT: Tid til næste kemoterapibehandling; NR: Ikke opnået ved det kliniske skæringstidspunkt.
English: The prepared infusion solution of rituximab in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2 °C - 8 °C and subsequently 24 hours at room temperature (not more than 30 °C).
Danish: Den tilberedte rituximab infusionsopløsning er i 0.9 % natriumchlorid opløsning fysisk og kemisk stabil i 30 dage ved 2 °C - 8 °C og efterfølgende 24 timer ved stuetemperatur (ikke over 30 °C).
English: The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
Danish: Den farmakokinetiske profil af rituximab, når det blev givet som 6 infusioner af 375 mg/m2 i kombination med 6 serier af CHOP kemoterapi, var sammenlignelig med den for rituximab indgivet som monoterapibehandling.
English: • What the signs of an infection are
Danish: • Symptomer på en infektion
English: • swelling of the hands or ankles
Danish: • hævede hænder eller ankler
English: • inflammation of blood vessels including those leading to skin symptoms
Danish: • irritation i blodkarrene, der kan medføre hudsymptomer
English: In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Danish: I studier, som evaluerede rituximab i kombination med kemoterapi var hyppigheden af arytmier af grad 3 og 4, fortrinsvis supraventrikulære arytmier, som f.eks. takykardi og atrieflagren/atrieflimren, højere i R-CHOP-gruppen (14 patienter, 6,9 %) sammenlignet med CHOP-gruppen (3 patienter, 1,5 %).
English: Studies 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: Ritemvia, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Danish: Ritemvia er i kombination med glukokortikoider indiceret til behandling af voksne patienter med svær, aktiv granulomatose med polyangiitis (Wegeners granulomatose) (GPA) eller mikroskopisk polyangiitis (MPA).
English: • The other ingredients are sodium chloride, tri-sodium citrate dihydrate, polysorbate 80 and water for injections.
Danish: • Øvrige indholdsstoffer: Natriumchlorid, trinatriumcitratdihydrat, polysorbat 80 og vand til injektionsvæsker.
English: In the overall experience of rituximab repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Danish: Ved gentagen behandling af patienter med reumatoid artrit med rituximab gennem et år er den samlede erfaring, at andelen af patienter med positive antistoftitere over for S. pneumoniae, influenza, mæslinger, røde hunde, skoldkopper og tetanustoksoid generelt var sammenlignelige til andelen ved baseline.
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group．
Danish: Forskellen i den samlede overlevelse viste en stærk klinisk forskel (p = 0,029, log rank test stratificeret ved center): overlevelsesrater på 53 måneder var 80,9 % for patienter i R-CVP-gruppen i forhold til 71,1 % for patienter i CVP-gruppen.
English: In the maintenance therapy clinical trial, the incidence of all-grade neutropenia was 0% for rituximab-treated 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: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 2,6% af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: • Feeling generally unwell or listless.
Danish: • Generel følelse af utilpashed eller sløvhed
English: • producing more tears, tear duct problems, inflamed eye (conjunctivitis)
Danish: • tåreflåd, problemer med tårekanaler, irriterede øjne (konjunktivitis)
English: • infections, such as chest infections, urinary tract infections (pain on passing water), colds and herpes infections
Danish: • infektioner som f.eks. luftvejsinfektioner, urinvejsinfektion (smerter ved vandladning), forkølelse og herpesudbrud
English: In a prospective, open label, international, multicentre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or rituximab plus CHOP (R-CHOP, n=234).
Danish: I et prospektivt, ublindet, internationalt, multicenter fase III-studie, blev 465 patienter med recidiveret/ refraktært follikulært lymfom i første omgang randomiseret til induktionsbehandling med enten CHOP (cyclophosphamid, doxorubicin, vincristin, prednisolon; n = 231) eller rituximab plus CHOP (R-CHOP, n = 234).
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The Patient information about Ritemvia should contain the following key elements:
Danish: Information til patienten om Ritemvia skal indeholde følgende nøgle-elementer: