FrancophonIA/ELRC3.0 huggingface dataset:
English: Rixathon is a clear, colourless to slightly yellowish solution, supplied as a concentrate for solution for infusion.
Danish: Rixathon er en klar, farveløs til let gullig opløsning, leveret som koncentrat til infusionsvæske, opløsning.
English: The prepared Rixathon solution should be administered as an intravenous infusion through a dedicated line.
Danish: Den tilberedte Rixathon-opløsning skal gives som en intravenøs infusion gennem en separat anlagt intravenøs adgang.
English: In a prospective, open label, international, multi-centre, 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: Table 11 Treatment of relapsed/refractory chronic lymphocytic leukaemia - overview of efficacy results for rituximab plus FC vs. FC alone (25.3 months median observation time)
Danish: Tabel 11 Behandling af relapsed/refraktær kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for rituximab plus FC versus FC alene (median observationstid: 25,3 måneder)
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 Rixathon.
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 Rixathon.
English: In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC
Danish: I CLL 1. linjestudiet oplevede Binet C patienter i R-FC-armen flere bivirkninger sammenlignet med patienter i FC-armen (R-FC 83 % versus FC 71 %).
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Rixathon.
Danish: Hvis du er i tvivl, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden du får Rixathon.
English: Granulomatosis with polyangiitis and microscopic polyangiitis Patients treated with Rixathon must be given the patient alert card with each infusion.
Danish: Granulomatose med polyangiitis og mikroskopisk polyangiitis Patienter behandlet med Rixathon skal have udleveret patientkortet ved hver infusion.
English: Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.
Danish: Natriumcitrat, polysorbat 80, natriumchlorid, natriumhydroxid, saltsyre, vand til injektionsvæsker.
English: Your doctor may need to take special care of you during your treatment with Rixathon.
Danish: Du kan have behov for ekstra overvågning under din behandling med Rixathon.
English: e) If you are being treated for pemphigus vulgaris
Danish: e) Hvis du behandles for pemfigus vulgaris
English: In case of such an event with a suspected relationship to Rixathon, treatment should be permanently discontinued.
Danish: Hvis en sådan bivirkning skulle opstå med formodet relation til Rixathon, skal behandlingen seponeres permanent.
English: 1 vial contains 10 mg/mL rituximab.
Danish: 1 hætteglas indeholder 10 mg/ml rituximab.
English: What you need to know before you are given Rixathon Do not take Rixathon if
Danish: Det skal du vide, før du begynder at få Rixathon Du må ikke få Rixathon, hvis
English: Hepatitis-B reactivation
Danish: Hepatitis B-reaktivering
English: • Rixathon will be given to you on the same day as your chemotherapy.
Danish: • Rixathon gives samme dag som kemoterapien.
English: Rixathon 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: Rixathon skal administreres som to 500 mg intravenøse infusioner, med to ugers mellemrum, efterfulgt af en 500 mg intravenøs infusion hver 6. måned.
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 - 49 days).
Danish: Baseret på den farmakokinetiske populationsanalyse af data fra 97 patienter med GPA eller MPA, der fik 375 mg/m2 rituximab én gang ugentligt i 4 uger, var den estimerede mediane terminale halveringstid 23 dage (9-49 dage).
English: Paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety
Danish: Nervesystemet paræstesi, hypoæstesi, agitation, insomni, vasodilatation, svimmelhed, angst
English: All physicians who are expected to prescribe Rixathon for non-oncology indications are provided with the following: - Product information - HCP educational leaflet - Patient educational leaflet
Danish: Alle læger, som kan forventes at udskrive Rixathon mod ikke-onkologiske indikationer, har modtaget følgende: - Produktresuméet - Undervisningsbrochure til sundhedspersonale - Undervisningsbrochure til patienter
English: In the maintenance therapy clinical trial, 7/57 (12%) patients in the rituximab arm experienced at least one infusion-related reaction.
Danish: I det kliniske studie med vedligeholdelsesbehandling oplevede 7 ud af 57 (12 %) patienter i rituximab-armen mindst én infusionsrelateret reaktion.
English: In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149 - 470) at the 6-month primary endpoint.
Danish: I det kliniske studie med induktion af remission blev kardielle bivirkninger rapporteret med en hyppighed på ca. 273 pr. 100 patientår (95 % konfidensinterval 149-470) ved det primære endepunkt ved måned 6.
English: c) If you are being treated for rheumatoid arthritis
Danish: c) Hvis du behandles for reumatoid artrit
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 rituximab.
Danish: Lægemidler til behandling af overfølsomhedsreaktioner, såsom epinephrin (adrenalin), antihistamin og glukokortikoid bør være tilgængelige til umiddelbar anvendelse i tilfælde af en allergisk reaktion under indgift af rituximab.
English: The chemotherapy should be given after the Rixathon infusion.
Danish: Kemoterapien skal gives efter infusionen med Rixathon.
English: +Myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Danish: +myokardieinfark t4 og 6, arytmier, +atrieflimren, takykardi, +hjertesygdom
English: Figure 4: Number of patients who were off or on minimal corticosteroid (≤10mg/day) therapy over time
Danish: Antallet af patienter uden kortikosteroid-behandling eller behandlet med minimalt kortikosteroid (≤ 10 mg/dag) over tid
English: The percentage of patients reporting ADRs upon re-treatment with further courses of rituximab 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 rituximab-serier var sammenlignelig med andelen af patienter, der rapporterede bivirkninger efter induktionsbehandling (alle bivirkninger og bivirkninger af grad 3/4).
English: Patients in both arms received 1,000 mg of pulse intravenous methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Danish: I begge arme fik patienterne intravenøs pulsbehandling med 1.000 mg methylprednisolon (eller andet glukokortikoid i ækvivalent dosis) pr. dag i 1-3 dage efterfulgt af oral prednison (1 mg/kg/dag, dog højst 80 mg/dag).
English: The recommended dosage of Rixathon is 1,000 mg by intravenous infusion followed by a second 1,000 mg intravenous infusion two weeks later.
Danish: Den anbefalede dosis af Rixathon er 1.000 mg ved intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion to uger senere.
English: Table 1 ADRs reported in clinical trials or during postmarketing surveillance in patients with NHL and CLL disease treated with rituximab monotherapy/maintenance or in combination with chemotherapy
Danish: Tabel 1 Sammenfatning af bivirkninger, som blev rapporteret i kliniske studier eller under post-marketing overvågning, hos patienter med NHL og CLL, som fik rituximab monoterapi eller vedligeholdelsesbehandling med rituximab, eller i kombination med kemoterapi
English: In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusionrelated by investigators in the safety population.
Danish: Infusionsrelaterede reaktioner i det kliniske studie, hvor man så på induktion af remission hos patienter med svær, aktiv GPA eller MPA blev defineret som enhver bivirkning, der opstod inden for 24 timer efter en infusion i sikkerhedspopulationen, og som af investigator blev anset som værende infusionsrelateret.
English: The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
Danish: Følgende reaktioner blev indberettet som bivirkninger under de kliniske studier, men blev rapporteret med samme eller lavere hyppighed i rituximab-armen, sammenlignet med kontrolarmene: hæmatotoksicitet, infektioner hos neutropene patienter, urinvejsinfektioner, sensoriske forstyrrelser og pyreksi.
English: Table 9 Maintenance phase: overview of efficacy results rituximab vs. observation (28 months median observation time)
Danish: Tabel 9 Vedligeholdelsesfase: Oversigt over effektdata for rituximab versus observation (28 måneders median observationstid)
English: Cranial neuropathy, loss of other senses5
Danish: kraniel neuropati, tab af andre sanser5
English: These symptoms are usually reversible with interruption of rituximab infusion and administration of an anti-pyretic, an antihistaminic and occasionally oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Danish: Disse symptomer er sædvanligvis reversible, når rituximab-infusionen afbrydes, og der administreres et antipyretikum, et antihistamin og undertiden oxygen, intravenøst saltvand eller bronchodilaterende midler og glukokortikoider om nødvendigt.
English: Following two intravenous infusions of rituximab at a dose of 1,000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 L (range, 1.7 to 7.51 L).
Danish: Efter to intravenøse infusioner af rituximab i en dosis på 1.000 mg med to ugers interval, var den gennemsnitlige halveringstid 20,8 dage (i intervallet 8,58 dage til 35,9 dage), den gennemsnitlige systemiske clearance var 0,23 l/dag (i intervallet 0,091 til 0,67 l/dag) og det gennemsnitlige steady-state fordelingsvolumen var 4,6 l (i intervallet 1,7 til 7,51 l).
English: In patients with non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, premedication with glucocorticoids should be considered if Rixathon 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 Rixathon ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
English: b) If you are being treated for chronic lymphocytic leukaemia
Danish: b) Hvis du behandles for kronisk lymfatisk leukæmi
English: In the clinical trial on induction of remission, the incidence of malignancy in rituximab treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period).
Danish: I det kliniske studie med induktion af remission var malignitetshyppigheden blandt rituximabbehandlede patienter i det kliniske studie med patienter med GPA eller MPA 2,00 pr. 100 patientår ved studiets slutning (da sidste patient havde gennemført opfølgningsperioden).
English: 2 vials of 10 mL 3 vials of 10 mL
Danish: 2 hætteglas a 10 ml 3 hætteglas a 10 ml
English: Progression of Kaposi's sarcoma has been observed in rituximab-exposed patients with pre-existing Kaposi's sarcoma.
Danish: Der er observeret progression af Kaposis sarkom hos rituximabeksponerede patienter med Kaposis sarkom.
English: • Fever or persistent cough
Danish: • Feber eller vedvarende hoste
English: • Additional risk minimisation measures For the indications non-Hodgkin´s lymphoma (NHL) and Chronic lymphocytic leukaemia
Danish: • Yderligere risikominimeringsforanstaltninger For indikationerne non-Hodgkin-lymfom (NHL) og kronisk lymfatisk leukæmi (CLL):
English: Other medicines and Rixathon
Danish: Brug af anden medicin sammen med Rixathon
English: • IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Danish: • Infusionsrelaterede reaktioner (herunder cytokinfrigivelsessyndrom, tumorlysesyndrom), se pkt.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1,000 mg per day is recommended prior to the first infusion of Rixathon (the last dose of methylprednisolone may be given on the same day as the first infusion of Rixathon).
Danish: Hos patienter med GPA eller MPA anbefales det at give methylprednisolon intravenøst i 1-3 dage i en dosis på 1.000 mg pr. dag inden den første Rixathon-infusion (sidste dosis methylprednisolon kan gives samme dag som første Rixathon-infusion).
English: Infusion-related reactions2
Danish: Infusionsrelaterede reaktioner2
English: ORR, % CR, % Median TTF/PFS/ EFS mo
Danish: Median TTF/PFS/ EFS måneder
English: In clinical trials more than 3,100 patients received at least one treatment course and were followed for periods ranging from 6 months to over 5 years; approximately 2,400 patients received two or more courses of treatment with over 1,000 having received 5 or more courses.
Danish: Ca. 2.400 patienter fik to eller flere behandlingsserier, heraf fik over 1.000 patienter fem eller flere behandlingsserier.
English: Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the Rixathon infusion.
Danish: Eftersom hypotension kan forekomme under administration af rituximab, bør det overvejes at afbryde behandling med antihypertensive lægemidler 12 timer før infusion med Rixathon.
English: During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with rituximab and observation.
Danish: Under vedligeholdelsesbehandlingen var hyppigheden af hjertesygdomme af grad 3/4 sammenlignelig mellem patienter behandlet i rituximab-gruppen og i observationsgruppen.
English: Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab arms compared to control arms.
Danish: Under kliniske studier har infektioner i de nedre luftveje (inklusive pneumoni) været rapporteret med en forekomst i rituximab-armene svarende til forekomsten i kontrolarmene.
English: • infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
Danish: • infektioner i blodet (sepsis), lungebetændelse, helvedesild, forkølelse, infektion i bronkierne, svampeinfektioner, infektioner af ukendt oprindelse, bihulebetændelse, leverbetændelse (hepatitis B)
English: Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Danish: Rixathon er indiceret til behandling af patienter med moderat til svær pemfigus vulgaris (PV).
English: In patients where the treatment is working, Rixathon may be used as a maintenance treatment for 2 years after completing the initial treatment.
Danish: Hvis behandlingen virker, kan Rixathon gives som vedligeholdelsesbehandling i 2 år efter, den første behandling er givet.
English: Rixathon is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Danish: Rixathon leveres i sterile, pyrogenfri hætteglas uden konserveringsmiddel til engangsbrug.
English: If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor.
Danish: Hvis du behandles for reumatoid artritis, granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris vil du også finde denne information i patientkortet, som du har fået af lægen.
English: A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
Danish: I alt 197 patienter i alderen 15 år og derover med svær, aktiv GPA (75 %) eller MPA (24 %) blev inkluderet og behandlet i et randomiseret, dobbeltblindet, placebokontrolleret, non-inferioritetsmulticenterstudie med aktiv kontrolgruppe.
English: Chronic lymphocytic leukaemia (CLL)
Danish: Kronisk lymfatisk leukæmi (CLL)
English: Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischaemia) in 3% of patients treated with rituximab compared to < 1% on observation.
Danish: Kardiale hændelser (herunder atrieflimren, myokardieinfarkt, venstre ventrikulært svigt og myokardieiskæmi) blev rapporteret som alvorlige bivirkninger hos 3 % af patienterne, som fik rituximab sammenlignet med < 1 % i observationsgruppen.
English: 18-months p=0.016
Danish: 18-måneder p=0,016
English: This is because in a few cases, Rixathon could cause hepatitis B to become active again, which can be fatal in very rare cases.
Danish: Det er vigtigt, fordi Rixathon i enkelte tilfælde har forårsaget, at en tidligere leverbetændelse (hepatitis B) er blevet aktiv igen.
English: Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal products 12 hours prior to the Rixathon infusion.
Danish: Da hypotension kan forekomme under infusion med rituximab, bør det overvejes at seponere antihypertensiva i 12 timer før Rixathoninfusionen.
English: • Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heartbeat, and tiredness
Danish: • ændringer i blodtryk, kvalme, udslæt, feber, en følelse af kløe, løbende eller stoppet næse og nysen, rysten, hurtig hjerterytme (puls) og træthed
English: Severe IRRs with fatal outcome have been reported in rheumatoid arthritis patients in the postmarketing setting.
Danish: Alvorlige infusionsrelaterede reaktioner med dødelig udgang er rapporteret hos patienter med reumatoid artrit efter markedsføring.
English: The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
Danish: Efter den femte 500 mg/m2 infusion var den gennemsnitlige Cmax (N=15) 408 µg/ml (spændvidde 97-764 µg/ml), og den gennemsnitlige terminale halveringstid var 32 dage (spændvidde 14-62 dage).
English: • tightening of the muscles in the airways which causes wheezing (bronchospasm), inflammation, irritation in the lungs, throat or sinuses, being short of breath, runny nose
Danish: • sammensnøring af musklerne i luftvejene, som forårsager hvæsende vejrtrækning (bronkospasme), inflammation (betændelseslignende reaktion), irritation i lungerne, halsen eller bihulerne, åndenød, løbende næse
English: 48-months p=0.0096
Danish: 48-måneder p=0,0096
English: Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections
Danish: Natriumchlorid Natriumhydroxid Saltsyre
English: Concentrate for solution for infusion 100 mg / 10 mL
Danish: Koncentrat til infusionsvæske, opløsning 100 mg/10 ml
English: Concentrate for solution for infusion 500 mg / 50 mL
Danish: Koncentrat til infusionsvæske, opløsning 500 mg/50 ml
English: The proportion of CTC Grade 3 events and of IRRs leading to withdrawal decreased by course and were rare from course 3 onwards.
Danish: CTC og af IRR, som førte til seponering, faldt med antal behandlingsserier og var sjældne fra 3. behandlingsserie og frem.
English: Rituximab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Danish: Det er vist, at rituximab i kombination med methotrexat reducerer hastigheden af ledskadeprogression, målt ved hjælp af røntgen, samt forbedrer fysisk funktionsevne.
English: The pharmacokinetics of rituximab were assessed following two intravenous doses of 500 mg and 1,000 mg on days 1 and 15 in four studies.
Danish: Farmakokinetikken for rituximab blev vurderet efter to i.v.-doser på 500 mg og 1.000 mg på dag 1 og 15 i fire studier.
English: All IRR symptoms were mild or moderate and most of them were reported from the SOCs Respiratory, Thoracic and Mediastinal Disorders and Skin and Subcutaneous Tissue disorders.
Danish: Alle infusionsrelaterede reaktioner var lette eller moderate, og de fleste af dem blev rapporteret under systemorganklasserne; Luftveje, thorax og mediastinum og Hud og subkutane væv.
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: Patients treated with Rixathon must be given the patient alert card with each infusion.
Danish: Patienter behandlet med Rixathon skal have udleveret patientkortet ved hver infusion.
English: Gastrointestinal Disorders
Danish: Gastrointestinale sygdomme
English: Rixathon monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
Danish: Rixathon monoterapi er indiceret til behandling af patienter med grad III-IV follikulært lymfom, som er resistente overfor kemoterapi eller som er i deres andet eller efterfølgende relaps efter kemoterapi.
English: You must also do this for 12 months after your last treatment with Rixathon.
Danish: I skal fortsætte med sikker prævention i 12 måneder efter din sidste behandling med Rixathon.