FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients treated with Rixathon for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris must be given the patient alert card with each infusion.
Danish: Alle patienter behandlet med Rixathon for reumatoid artrit, GPA, MPA eller PV skal have udleveret patientkortet ved hver infusion.
English: The recommended dosage of Rixathon for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Danish: Den anbefalede dosis af Rixathon til induktion af remission af GPA og MPA er 375 mg/m2 legemsoverfladeareal, administreret som intravenøs infusion, én gang ugentligt i 4 uger (4 infusioner i alt).
English: The recommended dose of Rixathon used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 infusions in total).
Danish: Den anbefalede dosis af Rixathon til vedligeholdelsesbehandling hos tidligere ubehandlede patienter med follikulært lymfom, som har responderet på induktionsbehandling, er 375 mg/m2 legemsoverfladeareal én gang hver 2. måned (startende 2 måneder efter den sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (12 infusioner i alt).
English: Arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Danish: Knogler, led, muskler og bindevæv artralgier / muskuloskeletale smerter, osteoartrit, bursitis
English: The recommended dose of Rixathon monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
Danish: Den anbefalede dosis af Rixathon monoterapi til induktionsbehandling hos voksne patienter med grad III-IV follikulært lymfom, som er resistente over for behandling med kemoterapi eller som er i deres anden eller efterfølgende recidiv efter kemoterapi, er 375 mg/m2 legemsoverfladeareal, givet som intravenøs infusion én gang ugentligt i 4 uger.
English: Depression, nervousness
Danish: • svimmelhed, nervøsitet
English: Rixathon is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Danish: Når Rixathon gives i kombination med binyrebarkhormon for at behandle sygdommen granulomatose med polyangiitis (blev tidligere kaldt Wegeners granulomatose) og mikroskopisk polyangiitis.
English: Rixathon 500 mg sterile concentrate rituximab
Danish: Rixathon 500 mg sterilt koncentrat rituximab
English: Following second infusion, mean Cmax ranged from 183 to 198 μg/mL for the 2 x 500 mg dose and ranged from 355 to 404 μg/mL for the 2 x 1,000 mg dose.
Danish: Efter den anden infusion varierede gennemsnittet for Cmax fra 183 til 198 μg/ml for doseringen på 2 × 500 mg og fra 355 til 404 μg/ml for doseringen på 2 × 1.000 mg.
English: • Infections, see section 4.4.
Danish: • Infektioner, se pkt.
English: Rixathon 100 mg concentrate for solution for infusion Rixathon 500 mg concentrate for solution for infusion
Danish: Rixathon 100 mg koncentrat til infusionsvæske, opløsning Rixathon 500 mg koncentrat til infusionsvæske, opløsning
English: Corticosteroids will usually be given by injection before the start of Rixathon treatment.
Danish: Du vil som regel få en indsprøjtning med binyrebarkhormon, inden behandlingen med Rixathon påbegyndes.
English: 4 see also section infusion related reactions below.
Danish: 3 se også afsnittet om hæmatologiske bivirkninger herunder 4 se også afsnittet om infusionsrelaterede reaktioner herunder.
English: Patients who have clinically significant cardiovascular disease, including arrhythmias, or previous serious infusion reactions to any prior biologic therapy or to rituximab, should not be administered the more rapid infusion.
Danish: Den hurtigere infusion bør ikke administreres til patienter, der har en klinisk signifikant kardiovaskulær sygdom, inklusive arytmier, eller tidligere har oplevet alvorlige infusionsreaktioner ved en hvilken som helst tidligere biologisk behandling eller ved rituximab.
English: Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p < 0.0001 log-rank test).The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
Danish: Vedligeholdelsesbehandling med rituximab gav en klinisk relevant og statistisk signifikant forbedring af det primære endpoint, PFS (tiden fra vedligeholdelsesrandomiseringen til relaps, sygdomsprogression eller død) sammenlignet med observation alene (p < 0,0001 log rank test).
English: Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 x 500 mg dose and ranged from 21 to 22 days for the 2 x 1,000 mg dose.
Danish: Efter anden infusion i den anden behandlingsserie var den gennemsnitlige terminale halveringstid for elimination 19 dage for doseringsgruppen 2 x 500 mg og varierede fra 21 til 22 dage for doseringsgruppen 2 × 1.000 mg.
English: (HBV) screening should be performed in all patients before initiation of treatment with Rixathon.
Danish: Alle patienter bør screenes for HBV før påbegyndelse af Rixathon-behandling.
English: Exacerbations of pre-existing cardiac conditions such as angina pectoris or congestive heart failure or severe cardiac disorders (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
Danish: Eksacerbationer af hjertelidelser som angina pectoris, kongestiv hjertesygdom eller alvorlige kardielle sygdomme (hjerteinsufficiens, myokardieinfarkt og atrieflimren), lungeødem, multiorgansvigt,
English: Dizziness may occur following administration of rituximab (see section 4.8).
Danish: Der kan opstå svimmelhed efter indgift af rituximab (se pkt.
English: Packs of 1 or 2 vials.
Danish: Pakninger med 1 eller 2 hætteglas.
English: c) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Danish: c) Hvis du behandles for granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: Therefore, in patients with a known cardiac history, and those who experienced prior cardiopulmonary adverse reactions, the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with Rixathon and patients closely monitored during administration.
Danish: Derfor bør risikoen for, at infusionen kan føre til kardiovaskulære komplikationer, overvejes før behandling med Rixathon hos patienter med kendte hjerteproblemer i anamnesen og hos patienter, som tidligere har oplevet kardiopulmonære bivirkninger.
English: Ninety-nine patients were treated for induction of remission of GPA and MPA in a clinical trial with rituximab (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Danish: I et klinisk studie blev 99 patienter behandlet med rituximab (375 mg/m2, én gang ugentligt i 4 uger) og glukokortikoider for induktion af remission af GPA og MPA (se pkt.
English: < 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Danish: Hos patienter med GPA eller MPA faldt antallet af B-celler i perifert blod til < 10 celler/mikroliter efter 2 ugentlige infusioner af rituximab 375 mg/m2 og forblev på dette niveau hos de fleste patienter til måned 6.
English: d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Danish: d) Hvis du behandles for granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: Body System
Danish: Systemorgankla sse
English: The recommended dose of Rixathon used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
Danish: • Recidiveret/ refraktært follikulært lymfom Den anbefalede dosis af Rixathon til vedligeholdelsesbehandling hos patienter med recidiveret/ refraktært follikulært lymfom, som har responderet på induktionsbehandling, er 375 mg/m2 legemsoverfladeareal én gang hver 3. måned (startende 3 måneder efter den sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (8 infusioner i alt).
English: Clinical experience in Non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Danish: Klinisk erfaring ved non-Hodgkin-lymfom og kronisk lymfatisk leukæmi
English: Hazard ratio (95% CI)
Danish: Forskel (konfidensinterval 95 %)
English: Cmax following second infusion, was 207 μg/mL for the 2 x 500 mg dose and ranged from 377 to 386 μg/mL for the 2 x 1,000 mg dose.
Danish: Efter den anden infusion var gennemsnittet for Cmax 270 μg/ml for doseringen på 2 × 500 mg og varierede fra 377 til 386 μg/ml for doseringen på 2 x 1.000 mg.
English: • A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems
Danish: • en trykkende følelse eller en dunkende smerte bag næse, kinder og øjne (bihulebetændelse),
English: d) Granulomatosis with polyangiitis or microscopic polyangiitis
Danish: d) Granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 μg/mL for 2 x 500 mg dose and ranged from 298 to 341 μg/mL for 2 x 1,000 mg dose.
Danish: Efter første infusion varierede gennemsnittet for Cmax for serum-rituximab fra 157 til 171 μg/ml for doseringen på 2 x 500 mg og fra 298 til 341 μg/ml for doseringen på 2 × 1.000 mg.
English: Anaphylaxis Tumour lysis syndrome, cytokine release syndrome4, serum sickness
Danish: Immunsystemet infusionsrelaterede reaktioner, angioødem hypersensitivitet anafylaksi tumorlysesyndrom, cytokinfrigivelsessyndrom4, serumsygdo m infusionsrelateret akut, reversibel trombocytop eni4
English: neutropenia3
Danish: sen neutropeni3
English: Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Danish: Tabel 4 Bivirkninger opstået hos ≥ 5 % af patienterne i vedligeholdelsesbehandling med rituximab for granulomatose med polyangiitis (Wegeners granulomatose) og mikroskopisk polyangiitis, og ved en højere frekvens end sammenligningsgruppen.
English: Cardiovascular reactions during clinical trials with rituximab monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Danish: Kardiovaskulære bivirkninger blev rapporteret hos 18,8 % af patienterne i behandlingsperioden.
English: Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome.
Danish: For at nedsætte risikoen for tumorlysesyndrom hos CLL-patienter, anbefales det at give profylakse med tilstrækkelig hydrering og administration af urikosurika 48 timer før behandlingens start.
English: • memory loss, trouble thinking, difficulty walking or sight loss -these may be due to a very rare,
Danish: • hukommelsestab, koncentrationsbesvær, besvær med at gå eller synstab - dette kan skyldes en meget sjælden, alvorlig hjerneinfektion, der i nogle tilfælde har været dødelig (progressiv multifokal leukoencefalopati eller PML).
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 x 500 mg dose and 317 to 370 μg/mL for 2 x 1,000 mg dose.
Danish: Efter første infusion varierede gennemsnittet for Cmax for serum-rituximab fra 170 til 175 μg/ml for doseringen på 2 × 500 mg og fra 317 til 370 μg/ml for doseringen på 2 × 1.000 mg.
English: CHOP R-CHOP
Danish: R-CHOP NR
English: Rixathon should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Danish: 4.3) eller til alvorligt immunkompromitterede patienter (for eksempel hvor CD4- eller CD8-niveauerne er meget lave).
English: General disorders and administratio n site conditions
Danish: Almene symptomer og reaktioner på administrations-stedet
English: Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171-1,177 µg/mL) after the eighth infusion.
Danish: Efter hver infusion steg den gennemsnitlige Cmax, fra et gennemsnit på 243 µg/ml (spændvidde 16-582 µg/ml) efter den første infusion til 550 µg/ml (spændvidde 171-1177 µg/ml) efter den ottende infusion.
English: IgM levels4
Danish: Undersøgelser nedsat IgMniveauer4
English: p-value a
Danish: p-værdi
English: IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with to those seen for rheumatoid arthritis patients in clinical trials (see section 4.8).
Danish: Infusionsrelaterede reaktioner hos patienter med GPA, MPA og PV var i overensstemmelse med dem, der sås i kliniske studier med patienter med reumatoid artrit (se pkt.
English: At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of
Danish: En efterfølgende analyse af længden af overlevelsen, udført med en median opfølgningsperiode på 60 måneder, bekræftede fordelene ved R-CHOP behandlingen i forhold til CHOP behandlingen (p=0,0071), hvilket svarer til en risikoreduktion på 32 %.
English: +pancytopenia, +granulocytopenia disorders, aplastic anaemia, haemolytic anaemia, lymphadeno pathy increase in serum IgM levels3
Danish: Blod og lymfesystem neutropeni, leukopeni, +febril neutropeni, +trombocyto peni anæmi, +pancytopeni, +granulocytopeni koagulatio ns sygdomme, aplastisk anæmi, hæmolytis k anæmi, lymfadeno pati forbigående stigning i serum IgM3
English: What Rixathon is and what it is used for What you need to know before you are given Rixathon How Rixathon is given
Danish: Det skal du vide, før du begynder at få Rixathon Sådan gives Rixathon
English: Table 2 Summary of ADRs reported in clinical trials or during postmarketing surveillance occurring in patients with rheumatoid arthritis receiving rituximab System Organ Class
Danish: Tabel 2 Opsummering af bivirkningsreaktioner hos patienter med reumatoid artrit, som fik rituximab i kliniske studier eller i forbindelse med post-marketing overvågning.
English: • you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis,
Danish: • du har svært nedsat hjertefunktion eller svær, ukontrolleret hjertesygdom og har reumatoid artrit, granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris.
English: Rituximab infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.
Danish: rituximab-infusionen blev indgivet efter administration af en intravenøs infusion af 100 mg methylprednisolon.
English: In patients with rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Rixathon infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Danish: Hos patienter med reumatoid artrit, GPA eller MPA i sygdomsremission eller PV, bør præmedicinering i form af 100 mg methylprednisolon i.v.
English: Before giving a subsequent course of Rixathon treatment, patients should be re-evaluated for any potential risk for infections.
Danish: Patienter bør evalueres for enhver potentiel risiko for infektioner, før der gives efterfølgende behandling med Rixathon.
English: The most frequent adverse reactions considered due to receipt of rituximab IRRs.
Danish: De mest almindelige bivirkninger, der blev anset for at være relateret til administration af rituximab, var infusionsrelaterede reaktioner.
English: This medicinal product contains 11.5 mmol (263.2 mg) sodium per 50 mL vial.
Danish: Dette lægemiddel indeholder 11,5 mmol (263,2 mg) natrium pr. 50 ml hætteglas.
English: Hypertension, orthostatic hypotension, hypotension
Danish: Vaskulære sygdomme hypertension, orthostatisk hypotension, hypotension vaskulitis (fortrinsvis kutan), leukocytoklastisk vaskulitis
English: Your doctor may decide to stop your Rixathon treatment if these reactions are serious.
Danish: Hvis disse reaktioner er alvorlige, kan lægen vælge at stoppe behandlingen med Rixathon.
English: This medicine contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial.
Danish: Denne medicin indeholder 2,3 mmol (eller 52,6 mg) natrium pr. 10 ml hætteglas.
English: This medicine contains 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Danish: Denne medicin indeholder 11,5 mmol (eller 263,2 mg) natrium pr. 50 ml hætteglas.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Hvis patienten er på natrium- eller saltfattig diæt, skal der tages hensyn hertil.
English: Primary efficacy Progression-free survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Danish: Primært effektmål Progressionsfri overlevelse (median) log-rank p-værdi hazard ratio (95 % KI) risikoreduktion
English: TNLT (median) log-rank p value hazard ratio (95% CI) risk reduction
Danish: TNLT (median) log-rank p-værdi hazard ratio (95 % KI) risikoreduktion
English: Secondary efficacy Overall survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Danish: Sekundært effektmål Samlet overlevelse (median) log-rank p-værdi hazard ratio (95 % KI) risikoreduktion
English: Vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation
Danish: Knogler, led, muskler og bindevæv hypertoni, myalgier, artralgier, rygsmerter, nakkesmerter, smerter
English: In the pivotal trial, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/m2 of rituximab as an intravenous infusion once weekly for four weeks.
Danish: Induktionsbehandling, 1 dosis ugentligt til i alt 4 doser I det pivotale studie fik 166 patienter med recidiverende eller kemoterapi-resistent lavmalignt eller follikulært B-celle NHL 375 mg/m2 rituximab som intravenøs infusion én gang om ugen i fire uger.
English: Rixathon 100 mg concentrate for solution for infusion rituximab
Danish: Rixathon 100 mg koncentrat til infusionsvæske, opløsning rituximab
English: Rixathon 500 mg concentrate for solution for infusion rituximab
Danish: Rixathon 500 mg koncentrat til infusionsvæske, opløsning rituximab
English: The pharmacokinetic (PK) parameters in the anti-TNF inadequate responder population, following the same dosage regimen (2 x 1,000 mg, intravenous, 2 weeks apart), were similar with a mean maximum serum concentration of 369 μg/mL and a mean terminal half-life of 19.2 days.
Danish: De farmakokinetiske parametre hos patienter i populationen, der responderer utilstrækkeligt på antiTNF-behandling, var efter den samme dosis (2 x 1.000 mg, i.v.
English: Disease-free survivala Subgroup analysis PFS
Danish: Varighed til ny lymfombehandling 20,1 Sygdomsfri overlevelsea Analyse af undergrupper PFS
English: Tinnitus, ear pain
Danish: Øre og labyrint tinnitus, øresmerter høretab5
English: TNCT (median) log-rank p value hazard ratio (95% CI) risk reduction
Danish: TNCT (median) log-rank p-værdi hazard ratio (95 % KI) risikoreduktion
English: Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with Rixathon.
Danish: Kvinder i den fertile alder skal anvende sikker prævention under behandlingen og i 12 måneder efter behandlingen med Rixathon på grund af den lange retentionstid for rituximab hos B-celle-depleterede patienter.
English: Paraesthesia, migraine, dizziness, sciatica
Danish: Nervesystemet hovedpine paræstesi, migræne, svimmelhed, iskias
English: NR NR
Danish: CHOP NR
English: This medicinal product contains 2.3 mmol (52.6 mg) sodium per 10 mL vial.
Danish: Dette lægemiddel indeholder 2,3 mmol (eller 52,6 mg) natrium pr. 10 ml hætteglas.
English: n=98 n=48 n=50
Danish: n=48
English: Depression, anxiety
Danish: Psykiske forstyrrelser depression, angst
English: • The active ingredient in Rixathon is called rituximab.
Danish: • Aktivt stof: Rituximab.
English: Event-free survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Danish: Hændelsesfri overlevelse (median) log-rank p-værdi hazard ratio (95 % KI) risikoreduktion
English: Cardiac Disorders
Danish: Kardiovaskulære bivirkninger
English: • Skin reactions including hives, itching and rash
Danish: • hudreaktioner herunder nældefeber, kløe og udslæt
English: Blood and Neutropenia Anaemia,
Danish: Blod og lymfesystem neutropeni1
English: You may be asked not to take these other medicines 12 hours before you are given Rixathon.
Danish: 12 timer inden, du får Rixathon.
English: • Headache
Danish: • hårtab
English: Lacrimation disorder, conjunctivitis
Danish: Øjne forstyrrelse i tåreudskillelsen, konjunctivitis svært synstab5
English: 10 mL vial - Pack of 2 or 3 vials.
Danish: Pakningsstørrelse på 2 eller 3 hætteglas.
English: Severe bullous skin reactions, StevensJohnson Syndrome toxic epidermal necrolysis (Lyell's Syndrome)
Danish: Hud og subkutane væv kløe, udslæt, +alopeci urticaria, svedtendens, nattesved, +hudsygdomme svære bulløse hudreaktioner, StevensJohnsons syndrom, toksisk epidermal nekrolyse (Lyells syndrom)7
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: • Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide
English: In a multi-centre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for eight doses.
Danish: Induktionsbehandling, 1 dosis ugentligt til i alt 8 doser I et enkelt-arms multicenterstudie fik 37 patienter med recidiveret elle kemoterapi-resistent lavmalignt eller follikulært B-celle NHL 375 mg/m2 rituximab som intravenøs infusion ugentligt i otte doser.
English: − CI = confidence interval.
Danish: p-værdia konfidensintervalb
English: Response rate and CR rates analysed using Chi-squared Test. *: only applicable to patients achieving a CR, nPR, PR;
Danish: NR: ikke nået; n.a.: ikke relevant *: gælder kun for patienter, som opnåede CR, nPR eller PR **: gælder kun for patienter, som opnåede CR