FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious IRRs were uncommon (0.5% of patients) and were predominantly seen during the initial course.
Danish: Alvorlige infusionsrelaterede reaktioner var ikke almindelige (0,5 % af patienterne) og blev hovedsageligt set under den første behandlingsserie.
English: In these patients the rate of clinically relevant infection while on rituximab was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
Danish: Hos disse patienter var andelen af patienter, som fik klinisk relevant infektion under rituximab-behandling, 6,01 per 100 patientår i forhold til 4,97 per 100 patientår efter behandling med det biologiske DMARD.
English: The primary objective for the study was complete remission (complete epithelialisation and absence of new and/or established lesions) at month 24 without the use of prednisone therapy for two months or more (CRoff for ≥ 2 months).
Danish: Studiets primære formål var fuldstændig remission (fuldstændig epitelisering og fravær af nye og/eller etablerede læsioner) ved måned 24 uden brug af prednison-behandling i to eller flere måneder (CRoff ≥ 2 måneder).
English: Peripheral B cell counts declined below normal following completion of the first dose of rituximab.
Danish: Det perifere B-celletal faldt til under normalområdet efter den første dosis af rituximab.
English: Serious cardiac reactions were reported at a rate of 1.3 per 100 patient years in the rituximab treated patients compared to 1.3 per 100 patient years in placebo treated patients.
Danish: Alvorlige kardielle bivirkninger blev rapporteret med en hyppighed på 1,3 pr. 100 patientår hos patienter behandlet med rituximab sammenlignet med 1,3 pr. 100 patientår hos patienter behandlet med placebo.
English: Patients were stratified by baseline disease severity (moderate or severe) and randomised 1:1 to receive either rituximab and low-dose prednisone or standard-dose prednisone.
Danish: Patienterne blev stratificeret efter baseline sygdomssværhedsgrad (moderat eller svær) og randomiseret i forholdet 1:1 til behandling med enten rituximab og lavdosis prednison eller standarddosis prednison.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne angivet efter faldende alvorlighed.
English: R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI.
Danish: R-CHOP var associeret med bedre udfald for både høj-og lavrisikopatienter i forhold til aldersjusteret IPI.
English: • Information on the Patient Alert Card
Danish: • Informationen på patientkortet
English: The two adverse events that were reported were flu-like symptoms, with a dose of 1.8 g of rituximab and fatal respiratory failure, with a dose of 2 g of rituximab.
Danish: De to bivirkninger, som blev rapporteret, var influenzalignende symptomer ved en dosis på 1,8 g rituximab og letal respirationssvigt ved en dosis på 2 g rituximab.
English: The incidence of infusion-related 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: Rituximab was administered on the first day of each treatment cycle.
Danish: Rituximab blev administreret på første dag af hver behandlingsserie.
English: The overall incidence of IRRs in clinical trials was 23% with the first infusion and decreased with subsequent infusions.
Danish: Den samlede forekomst af infusionsrelaterede reaktioner i kliniske studier var 23 % ved første infusion og faldt ved følgende infusioner.
English: However, response rates to non-live vaccines may be reduced.
Danish: Dog kan responsrater efter vaccination med ikke-levende vacciner være nedsat.
English: Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
Danish: Andre rapporterede alvorlige bivirkninger omfatter hepatitis B-reaktivering og PML (se pkt.
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Ritemvia.
Danish: Hvis du er i den fødedygtige alder, skal du og din partner bruge sikker prævention, mens du er i behandling med Ritemvia.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following rituximab 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 Ritemvia i det omfang, det er relevant i henhold til lokale kliniske retningslinjer.
English: A total of 392/3095 (12.7%) patients with rheumatoid arthritis tested positive for ADA in clinical studies following therapy with rituximab.
Danish: Samlet blev 392/3.095 (12,7 %) af patienterne med reumatoid artrit testet positive for ADA i kliniske studier efter behandling med rituximab.
English: Binet stage A Binet stage B Binet stage C CI: Confidence Interval
Danish: Binet stadium A Binet stadium B Binet stadium C
English: The majority of these subjects were also exposed to cytotoxic chemotherapy.
Danish: Hovedparten af disse patienter fik også cytotoksisk kemoterapi.
English: Signs and symptoms included visual disturbance, headache, seizures and altered mental status, with or without associated hypertension.
Danish: Tegn og symptomer omfattede synsforstyrrelser, hovedpine, kramper samt ændret mental tilstand, med eller uden tilhørende hypertension.
English: No dose reductions of Ritemvia are recommended.
Danish: Der er ingen anbefalinger vedrørende dosisreduktion af Ritemvia.
English: Events of neutropenia were observed with rituximab treatment, the majority of which were transient and mild or moderate in severity.
Danish: Neutropeni har været observeret under rituximab behandling og i de fleste tilfælde var den forbigående og i mild eller moderat sværhedsgrad.
English: It is recommended that immunoglobulin levels are determined prior to initiating treatment with rituximab.
Danish: Det anbefales, at immunglobulinniveauer måles før initiering af rituximab-behandling.
English: Keep the container in the outer carton in order to protect from light.
Danish: Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: Severe infusion-related reactions with fatal outcome have been reported during post-marketing use of the rituximab intravenous formulation, with an onset ranging within 30 minutes to 2 hours after starting the first rituximab intravenous infusion.
Danish: Der er efter markedsføring rapporteret svære infusionsrelaterede reaktioner med dødeligt udfald ved brug af rituximab i intravenøs formulering, med indtræden inden for 30 minutter til 2 timer efter påbegyndelse af første rituximab intravenøs infusion.
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 gentagende infusioner (< 4 %).
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of rituximab treated patients and 0.27% (2/731) of placebo-treated patients developed severe neutropenia.
Danish: I placebokontrollerede perioder af kliniske studier udviklede 0,94 % (13/1382) af rituximab-behandlede patienter og 0,27 % (2/731) af placebo-behandlede patienter svær neutropeni.
English: A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy.
Danish: I alt blev 810 patienter (403 R-FC, 407 FC) i 1. linje studiet (tabel 10a og tabel 10b) og 552 patienter (276 R-FC, 276 FC) i relaps/refraktær studiet (tabel 11) analyseret for effekt.
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: Therefore vaccination with live virus vaccines is not recommended whilst on rituximab or whilst peripherally B cell depleted.
Danish: Derfor kan vaccination med levende, virale vacciner ikke anbefales samtidig med rituximab behandling, eller mens der er perifer B-celle depletion.
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: • low number of red blood cells (anaemia)
Danish: • lavt antal røde blodlegemer (anæmi)
English: Ritemvia is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Danish: Ritemvia er en klar, farveløs opløsning, leveret som koncentrat til infusionsvæske, opløsning i et hætteglas.
English: In clinical trials fewer than 1% (17/3189) of patients experienced a serious IRR.
Danish: I kliniske studier fik færre end 1 % (17/3.189) af patienterne en alvorlig IRR.
English: If you have heart disease or angina, these reactions might get worse.
Danish: Hvis du har hjerteproblemer eller angina pectoris kan symptomerne forværres.
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (antiCCP) 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: 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: Log-Rank p value
Danish: Log-rank p-værdi
English: The incidence of thrombocytopenia was low (<1%, grade 3/4) and was not different between treatment arms.
Danish: Hyppigheden af trombocytopeni var lav (< 1 %, grad 3/4), og der var ingen forskel mellem behandlingsarmene.
English: • heart problems - such as reduced heart rate or chest pain (angina)
Danish: • hjerteproblemer, f.eks. nedsat hjerteaktion eller brystsmerter (angina)
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 FCgruppen.
English: Ritemvia should be used in combination with CHOP chemotherapy.
Danish: Ritemvia bør anvendes i kombination med CHOP kemoterapi.
English: Talk to your doctor, pharmacist or nurse before you are given Ritemvia if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, inden du får Ritemvia, hvis:
English: 2Details on infusion related reactions are provided in the description of selected adverse drug reactions section.
Danish: 2Detaljer omkring infusionsrelaterede reaktioner er angivet i afsnittet ”Beskrivelse af udvalgte bivirkninger”.
English: • hearing loss, loss of other senses b) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Danish: • høretab og tab af andre sanser b) Hvis du behandles for granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: • severe skin problems causing blisters that can be life-threatening.
Danish: • svære hudproblemer med blister, der kan være livsfarlige.
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: • low mood and loss of interest or enjoyment in doing things, feeling nervous
Danish: • dårligt humør og manglende interesse eller glæde ved ting, nervøsitet
English: Skin papilloma * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
Danish: * Infusionsrelaterede reaktioner inkluderede symptomer indsamlet ved næste planlagte besøg efter hver infusion samt bivirkninger, der forekom på dagen eller dagen efter infusionen.
English: Clinically and statistically significant improvement was also noted on all individual components of the ACR response (tender and swollen joint counts, patient and physician global assessment, disability index scores (HAQ), pain assessment and C-Reactive Proteins (mg/dL).
Danish: Klinisk og statistisk signifikante forbedringer sås også på alle individuelle komponenter af ACR respons (antal ømme og hævede led, patientens og lægens overordnede bedømmelse, funktionsindeks score (HAQ), smerteevaluering og C-reaktivt protein (mg/dl)).
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 hypersensitivitetsreaktioner, for eksempel epinephrin (adrenalin), antihistaminer og glukokortikoider, bør være tilgængelige til øjeblikkelig anvendelse, i tilfælde af en allergisk reaktion under administration af rituximab.
English: In patients treated with cyclophosphamide (followed by azathioprine for maintenance of complete remission), 39% of patients achieved CR at 12 months, and 33% of patients achieved CR at 18 months.
Danish: I gruppen af patienter behandlet med cyclophosphamid (efterfulgt af azathioprin med henblik på opretholdelse af fuldstændig remission) opnåede 39 % af patienterne fuldstændig remission ved måned 12 og 33 % af patienterne fuldstændig remission ved måned 18.
English: The rate of all ADRs following first rituximab exposure was highest during the first 6 months and declined thereafter.
Danish: Efter første rituximab-eksponering var hyppigheden af alle bivirkninger højest i løbet af de første 6 måneder og aftog derefter.
English: Keep the container in the outer carton, in order to protect from light.
Danish: Opbevares i den ydre karton for at beskytte mod lys.
English: In the rituximab group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
Danish: I rituximab-gruppen opnåede 48 % af patienterne fuldstændig remission ved måned 12, og 39 % af patienterne opnåede fuldstændig remission ved måned 18.
English: Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Danish: Kliniske fund ved anafylaksi kan ligne de kliniske fund på cytokinfrigivelsessyndrom (beskrevet ovenfor).
English: Vaccination should be completed at least 4 weeks prior to first administration of rituximab.
Danish: Vaccinationerne bør være gennemført senest 4 uger inden første dosis af rituximab.
English: Very common side effects (may affect more than 1 in 10 people): allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion long lasting depression loss of hair
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter): A. allergiske reaktioner, som normalt forekommer under infusionen, men kan forekomme i op til 24 timer efter infusion B. langvarig depression C. hårtab
English: If a patient develops PML, the dosing of rituximab must be permanently discontinued.
Danish: Hvis en patient udvikler PML, skal behandlingen med rituximab seponeres permanent.
English: Remission-induction therapy included IV prednisone, administered as per the investigator's discretion, preceded in some patients by methylprednisolone pulses, and pulse cyclophosphamide until remission was attained after 4 to 6 months.
Danish: Remissions-induktionsbehandling inkluderede intravenøs prednison, administreret på investigators skøn, hos nogle patienter blev pulsbehandlinger med methylprednisolon givet forud for prednison, og cyclophosphamid pulsbehandlinger, indtil remission var opnået efter 4 til 6 måneder.
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Ritemvia.
Danish: Der bør altid gives præmedicin bestående af et anti-pyretisk lægemiddel samt et antihistamin, f.eks. paracetamol og diphenhydramin, inden hver Ritemvia-administration.
English: Medicines given before each Ritemvia administration
Danish: Medicin, der gives inden hver behandling med Ritemvia
English: Sodium chloride Tri-sodium citrate dihydrate Polysorbate 80
Danish: Natriumchlorid Trinatriumcitratdihydrat Polysorbat 80
English: Radiographic analysis at 2 years in Trial 1 demonstrated significantly reduced progression of structural joint damage in patients receiving rituximab in combination with methotrexate compared to methotrexate alone as well as a significantly higher proportion of patients with no progression of joint damage over the 2 year period.
Danish: Radiologisk analyse efter 2 år i studie 1 viste signifikant reduceret progression af strukturel ledskade hos patienter, som fik rituximab i kombination med methotrexat, sammenlignet med patienter, som fik methotrexat alene og viste også en signifikant højere andel af patienter uden ledskadeprogression over en periode på 2 år.
English: In a long-term observational safety study, 97 GPA/MPA patients received treatment with rituximab (mean of 8 infusions [range 1-28]) for up to 4 years, according to their physician's standard practice and discretion.
Danish: I et langvarigt observationssikkerhedsstudie fik 97 patienter med GPA og MPA behandling med rituximab (gennemsnitlig 8 infusioner [i intervallet 1-28]) i op til 4 år, efter lægens skøn og i henhold til standard praksis.
English: This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of Ritemvia treatment.
Danish: Dette bør efterfølges af prednison oralt, 1 mg/kg/dag (dog højst 80 mg/dag og nedtitreret så hurtigt som muligt afhængigt af det kliniske behov) under og efter de 4 ugers induktions behandling med Ritemvia.
English: The MAH must ensure that all physicians who are expected to prescribe Ritemvia are provided with the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som kan forventes at udskrive Ritemvia, har modtaget følgende:
English: At month 28, major relapse (defined by the reappearance of clinical and/or laboratory signs of vasculitis activity ([BVAS] > 0) that could lead to organ failure or damage or could be life threatening) occurred in 3 patients (5%) in the rituximab group and 17 patients (29%) in the azathioprine group (p=0.0007).
Danish: Ved måned 28 opstod der større recidiver (defineret som genkomsten af kliniske og/eller laboratorie tegn på vaskulitis-aktivitet ([BVAS] > 0), der kunne føre til organsvigt eller skade eller være livstruende) hos 3 patienter (5 %) i rituximab-gruppen og 17 patienter (29 %) i azathioprin-gruppen (p=0,0007).
English: Pack of 2 vials.
Danish: Pakning med 2 hætteglas.
English: All of these arrhythmias either occurred in the context of a rituximab infusion or were associated with predisposing conditions such as fever, infection, acute myocardial infarction or pre-existing respiratory and cardiovascular disease.
Danish: Alle arytmier indtraf enten sammen med infusion af rituximab eller havde relation til en prædisponerende tilstand som f.eks. feber, infektion, akut myokardieinfarkt eller præeksisterende respiratorisk eller kardiovaskulær sygdom.
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: • infections such as herpes infections and eye infection
Danish: • infektioner som f.eks. herpesudbrud og øjeninfektion
English: Three cases had no reported adverse event.
Danish: Tre havde ingen rapporterede bivirkninger.
English: The overall safety profile of rituximab in non-Hodgkin's lymphoma and CLL is based on data from patients from clinical trials and from post-marketing surveillance.
Danish: Rituximabs sikkerhedsprofil ved non-Hodgkin-lymfom og CLL er baseret på data fra patienter fra kliniske studier og fra post-marketing overvågning.
English: Infections were predominately mild to moderate.
Danish: Infektionerne var overvejende lette til moderate.
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: In order to improve traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Danish: Handelsnavnet og batchnummer på det anvendte produkt skal registreres (eller anføres) tydeligt i patientens journal for at sikre sporbarheden af biologiske lægemidler.
English: Table 6 Summary of key results from four phase III randomised studies evaluating the benefit of rituximab with different chemotherapy regimens in follicular lymphoma
Danish: Tabel 6 Opsummering af nøgleresultater fra fire fase-III-randomiserede studier, der evaluerer fordelene ved rituximab med forskellige kemoterapibehandlinger ved follikulært lymfom
English: Prednisone treatment was tapered and then kept at a low dose (approximately 5 mg per day) for at least 18 months after randomization.
Danish: Prednison-behandlingen blev nedtitreret og holdt på en lav dosis (cirka 5 mg pr. dag) i mindst 18 måneder efter randomiseringen.
English: Patients with a high tumour burden or with a high number (≥ 25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution.
Danish: Patienter med stor tumorbyrde eller med et højt antal (≥ 25 x 109/l) cirkulerende maligne celler, som f.eks. patienter med CLL, som kan have øget risiko for især svært cytokinfrigivelsessyndrom, bør behandles med yderste forsigtighed.
English: The consequences of long-term B cell depletion in paediatric patients are unknown.
Danish: Konsekvenserne af B-celle-depletion over lang tid hos pædiatriske patienter kendes ikke.
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1 (ITT population)
Danish: Tabel 12 Resultater for klinisk respons ved det primære endepunkt i studie 1 (ITT populationen)
English: Severe (grade 3/4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Danish: Svær (grad 3/4) neutropeni forekom hos 4,2 % af patienterne, svær anæmi hos 1,1 %, og svær trombocytopeni hos 1,7 %.
English: Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Danish: Rituximab bindes specifikt til det transmembrane antigen, CD20, et non-glycosyleret phosphoprotein som findes på præ-B og modne B-lymfocytter.