FrancophonIA/ELRC3.0 huggingface dataset:
English: The syndrome frequently manifests itself within one or two hours of initiating the first infusion.
Danish: Syndromet viser sig ofte indenfor en eller to timer efter starten på den første infusion.
English: Complete remission All Patients Newly diagnosed Relapsing
Danish: Fuldstændig remission Alle patienter Nyligt diagnosticerede
English: Similar effects have been observed in animal studies (see section 5.3).
Danish: Tilsvarende virkning er observeret i dyrestudier (se pkt.
English: Patients were followed beyond week 24 for long-term endpoints, including radiographic assessment at 56 weeks and at 104 weeks.
Danish: Patienterne blev fulgt efter uge 24 for langtidsendepunkter, inklusive en radiologisk vurdering i uge 56 og i uge 104.
English: Read the leaflet for further information.
Danish: Læs indlægssedlen for yderligere information.
English: Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Ireland
Danish: Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Irland
English: • you have a weak immune system
Danish: • du har et svagt immunforsvar.
English: Physical function and quality of life outcomes
Danish: Resultater for fysisk funktion og livskvalitet
English: You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant.
Danish: Du skal kontakte lægen eller sundhedspersonalet, hvis du er gravid, tror, du måske kan være gravid eller planlægger at blive gravid.
English: After adjusting for BSA, male subjects had a larger volume of distribution and a faster clearance than female subjects.
Danish: Efter justering for legemsoverflade, havde mandlige personer et højere fordelingsvolumen og en hurtigere clearance end kvindelige personer.
English: Patients should receive Ritemvia for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Danish: Patienter skal gives Ritemvia i mindst 24 måneder efter opnåelse af remission (fravær af kliniske symptomer).
English: • asthma, too little oxygen reaching the body organs
Danish: • astma, kroppens organer får for lidt ilt
English: Look out for the following possible signs of infection:
Danish: Hold øje med følgende mulige symptomer på en infektion:
English: Name and address of the manufacturer of the biological active substance
Danish: Navne og adresse på fremstilleren af det biologisk aktive stof
English: Rituximab is not indicated for these patients, since the safety data about long-term rituximab treatment are insufficient, in particular concerning the risk of development of malignancies and PML.
Danish: Rituximab er ikke indiceret til disse patienter, da sikkerhedsdata for langvarig rituximab-behandling er utilstrækkelig, specielt angående risikoen for udvikling af maligniteter og PML.
English: Table 14 Physical function and quality of life outcomes at week 24 in Trial 1
Danish: Tabel 14 Resultater for fysisk funktion og livskvalitet ved uge 24 i studie 1
English: This medicinal product contains sodium.
Danish: Dette lægemiddel indeholder natrium.
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Ritemvia.
Danish: • Vis dette kort til enhver læge, sygeplejerske eller tandlæge, som er involveret i din behandling - og ikke kun til den læge, der udskriver Ritemvia til dig
English: Post-hoc retrospective laboratory evaluation
Danish: Post-hoc retrospektiv laboratorieevaluering
English: CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
Danish: CD20 cirkulerer ikke i plasmaet som et frit antigen og konkurrerer derfor ikke for antistof binding.
English: Patients were between 19 and 79 years of age and had not received prior therapies for pemphigus.
Danish: Patienterne var mellem 19 og 79 år og havde ikke tidligere fået behandling for pemfigus.
English: Patients with active hepatitis B disease should not be treated with rituximab.
Danish: Patienter med aktiv hepatitis B-sygdom bør ikke behandles med rituximab.
English: This antigen does not internalize upon antibody binding and is not shed from the cell surface.
Danish: Dette antigen ændres ikke efter antistof binding og fjernes ikke fra celleoverfladen.
English: The healthcare provider should also consider resuming or increasing the patient's glucocorticoid dose based on clinical evaluation.
Danish: Lægen skal også overveje at genoptage eller øge dosis af patientens glukokortikoid-behandling baseret på den kliniske vurdering.
English: • reduced platelets number just after the infusion - this can be reversed, but can be fatal in rare cases
Danish: • nedsat antal blodplader umiddelbart efter infusionen; dette kan rette sig, men kan i sjældne tilfælde være dødeligt
English: Please talk to your doctor or nurse if you have any questions about the information in this card.
Danish: Kontakt lægen eller sundhedspersonalet, hvis du har nogle spørgsmål angående informationen på dette kort.
English: Azathioprine 59 56 52 50 47 47 44 44 42 41 40 39 36 34 0 Rituximab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
Danish: Azathioprin 59 56 52 50 47 47 44 44 42 41 40 39 36 34 0 Rituximab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6)
Danish: • du er allergisk over for rituximab, andre proteiner, der ligner rituximab eller et af de øvrige indholdsstoffer i Ritemvia (angivet i punkt 6).
English: This is a type of protein called a “monoclonal antibody”.
Danish: Det er en type protein, der kaldes et monoklonalt antistof.
English: No patients were withdrawn from treatment due to infusion-related reactions.
Danish: Ingen patienter fik afbrudt behandling på grund af infusionsrelaterede reaktioner.
English: Your doctor may change this, depending on how you respond to the medicine.
Danish: Din læge kan ændre dette, afhængigt af hvordan du reagerer på behandlingen.
English: See the Ritemvia package leaflet for more information.
Danish: Se indlægssedlen i Ritemvia-pakken for mere information.
English: Table 17 Complete remission at 6-months by disease status Rituximab
Danish: Tabel 17 Fuldstændig remission ved måned 6 opgjort efter sygdomsstatus Rituximab
English: Final analysis (median FU: 9.0 years)
Danish: Final analyse (median opfølgning: 9,0 år)
English: Limited information from one study in relapsed/refractory CLL patients suggests that rituximab treatment may also worsen the outcome of primary hepatitis B infections.
Danish: Begrænset information fra et studie med relaps/refraktære CLL-patienter indikerer, at rituximab-behandling også kan forværre udfaldet af primære hepatitis B-infektioner.
English: Your doctor will check if you should have any vaccines before you receive Ritemvia.
Danish: Din læge vil undersøge, om du bør vaccineres inden du får Ritemvia.
English: Mean Cmax was 16 to 19% higher following second infusion compared to the first infusion for both doses.
Danish: Gennemsnittet for Cmax var 16 til 19 % højere efter anden infusion sammenlignet med den første infusion for begge doser.
English: Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins to patients.
Danish: Anafylaktiske og andre hypersensitivitetsreaktioner er blevet rapporteret efter intravenøs administration af proteiner til patienter.
English: Bronchitis Rhinitis
Danish: Bronkitis Rhinitis
English: • mood disorders such as irritability and depression
Danish: • humørsvingninger såsom irritabilitet og depression
English: Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome.
Danish: Yderligere behandling af patienter efter fuldstændig ophør af kliniske fund og symptomer har sjældent resulteret i gentagelse af alvorligt cytokinfrigivelsessyndrom.
English: During or within the first 24 hours of the infusion you may develop fever, chills and shivering.
Danish: Under eller inden for de første 24 timer af infusionen kan du få feber, kuldegysninger og rysten.
English: • The need to monitor patients for infections, especially PML, during and after Ritemvia treatment
Danish: • Nødvendigheden af at overvåge patienterne for infektioner, især PML, under og efter behandling med Ritemvia
English: The incidence of all grade infections was similar between the arms.
Danish: Forekomsten af infektioner af alle grader var sammenlignelig mellem armene.
English: Exploratory analyses of the benefit of maintenance treatment showed a less pronounced effect in elderly patients (> 70 years of age), however sample sizes were small.
Danish: Eksplorative analyser af fordelen ved vedligeholdelsesbehandling viste en mindre udtalt effekt hos ældre patienter (> 70 år), dog var stikprøvestørrelserne små.
English: Only the highest frequency observed in the trials is reported
Danish: Der er kun angivet den højest observerede hyppighed fra studierne.
English: It remains unknown if early detection of PML and suspension of rituximab therapy may lead to similar stabilisation or improved outcome.
Danish: Det er uvist, om tidlig erkendelse af PML og seponering af rituximab-behandlingen kan føre til lignende stabilisering eller forbedret tilstand.
English: In the post-marketing setting five cases of rituximab overdose have been reported.
Danish: Efter markedsføring er der rapporteret fem tilfælde af rituximab-overdosering.
English: Frequencies are defined as very common (≥ 1/10), common
Danish: Frekvenserne er defineret som meget almindelig (≥ 1/10),
English: At week 48 seropositive patients were 2-3 times more likely to achieve ACR responses compared to seronegative patients.
Danish: Ved uge 48 var det 2-3 gange mere sandsynligt for seropositive patienter at opnå ACRrespons sammenlignet med seronegative patienter.
English: Rituximab was given in combination with intravenous glucocorticoids which may reduce the incidence and severity of these events.
Danish: Rituximab blev givet i kombination med intravenøst glukokortikoid, som kan reducere incidensen og sværhedsgraden af sådanne hændelser.
English: Table 13 Radiographic outcomes at 1 year (mITT population)
Danish: Tabel 13 Radiologiske resultater ved 1 år i studie 1 (mITT population)
English: From month 12 to month 18, 8 relapses were observed in the rituximab group compared with four in the cyclophosphamide group.
Danish: Fra måned 12 til måned 18 observeredes 8 tilfælde af relaps i rituximabgruppen sammenlignet med 4 i cyclophosphamid-gruppen.
English: For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Danish: For patienter randomiseret til vedligeholdelsesdelen af studiet var den mediane observationstid 28 måneder fra vedligeholdelsesrandomiseringen.
English: A statistically significant correlation was noted between response rates and bone marrow involvement.
Danish: Der blev set en statistisk signifikant korrelation mellem responsrate og involvering af knoglemarven.
English: The Physician information and Patient information must be agreed with the National Competent Authorities prior to distribution and Patient Alert Card should be included as part of inner packaging.
Danish: Informationen til lægen og informationen til patienten skal godkendes af den nationale sundhedsmyndighed, inden materialerne distribueres, og patientkortet skal inkluderes som en del af den indre emballage.
English: Ritemvia will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Danish: Du får Ritemvia af en læge eller sygeplejerske med erfaring i denne behandling.
English: Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR).
Danish: Kvalificerede patienter havde aktiv reumatoid artrit diagnosticeret ifølge kriterierne fra American College of Rheumatology (ACR).
English: The safety and efficacy of Ritemvia in children below 18 years has not been established.
Danish: Ritemvias sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Prednisone tapering was to be completed by 6 months from the start of study treatment.
Danish: Nedtitrering af prednison skulle være gennemført 6 måneder efter start af studiebehandling.
English: Repeated treatment courses with Ritemvia are possible.
Danish: Gentagne behandlingsforløb med Ritemvia er mulige.
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Danish: Immunomodulerende lægemidler kan øge risikoen for maligne sygdomme.
English: Population pharmacokinetic analysis revealed that BSA and gender were the most significant covariates to explain inter-individual variability in pharmacokinetic parameters.
Danish: Farmakokinetisk analyse af populationen viste, at legemsoverflade og køn var de mest signifikante co-variable, til forklaring af inter-individuel variation i farmakokinetiske parametre.
English: Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing disease (Table 17).
Danish: Der blev observeret effekt både hos nyligt diagnosticerede patienter og hos patienter med recidiverende sygdom (tabel 17).
English: Prednisone dose tapering and the decision to stop prednisone treatment after month 18 were left at the investigator's discretion.
Danish: Prednison dosis nedtitrering og beslutningen om at stoppe prednison-behandling efter måned 18 var op til investigators skøn.
English: For CLL patients similar results are assumable considering similarities between both diseases but that has not been investigated in clinical trials.
Danish: Hos CLL-patienter forventes lignede resultater, når lighederne mellem sygdommene tages i betragtning, men det er ikke undersøgt i kliniske studier.
English: What are the signs of getting an infection?
Danish: Hvad er symptomerne på en infektion?
English: IRRs may occur as a result of hypersensitivity and/or to the mechanism of action.
Danish: Infusionsrelaterede reaktioner kan forekomme som følge af hypersensitivitet og/eller virkningsmekanismen.
English: Neither age, sex, lymphoma grade, initial diagnosis, presence nor absence of bulky disease, normal or high LDH nor presence of extranodal disease had a statistically significant effect (Fisher's exact test) on response to rituximab.
Danish: Hverken alder, køn, lymfomgrad, initial diagnose, tilstedeværelse eller fravær af udbredt sygdom, normal eller høj LD, eller tilstedeværelse af ekstranodal sygdom havde statistisk signifikant effekt (Fisher's exact test) på responset på rituximab.
English: • Signs of PML include: - Confusion, memory loss or problems thinking - Loss of balance or a change in the way you walk or talk - Decreased strength or weakness on one side of your body - Blurred vision or loss of vision.
Danish: • Symptomer på PML inkluderer: - Forvirring, hukommelsestab eller koncentrationsbesvær - Balancetab eller ændringer i din måde at gå eller tale på - Nedsat styrke eller svækkelse af den ene side af din krop - Sløret syn eller synstab
English: Seropositive patients also had a significantly greater decrease in DAS28-ESR compared to seronegative patients (Figure 1).
Danish: Seropositive patienter havde desuden et signifikant større fald i DAS28-ESR sammenlignet med seronegative patienter (figur 1).
English: Treatment start date and contact details
Danish: Dato for behandlingsstart og kontaktoplysninger
English: The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
Danish: Den mediane PFS var 42,2 måneder i rituximab vedligeholdelsesarmen sammenlignet med 14,3 måneder i observationsarmen.
English: Figure 2: ACR responses for 4 treatment courses (24 weeks after each course (within patient, within visit) in patients with an inadequate response to TNF-inhibitors (n=146)
Danish: Figur 2: ACR-respons for fire behandlingsserier (24 uger efter hver behandlingsserie (inden for patient og besøg) hos patienter med et utilstrækkeligt respons over for TNFhæmmere (n = 146)
English: The proportions of patients experiencing cardiac reactions (all or serious) did not increase over multiple courses.
Danish: Andelen af patienter, som oplevede kardielle bivirkninger (alle eller alvorlige), steg ikke ved gentagne behandlingsserier.
English: • long lasting depression
Danish: • langvarig depression
English: Your doctor may prescribe Ritemvia for the treatment of:
Danish: Din læge kan ordinere Ritemvia til behandling for:
English: Dyspnoea Epistaxis Nasal congestion
Danish: Epistaxis Nasal congestion
English: Rarely, some of these reactions have been fatal.
Danish: Sjældent har nogle af disse bivirkninger været dødelige.
English: All patients were followed until month 28 (10 or 6 months, respectively, after the last rituximab infusion or azathioprine dose).
Danish: Alle patienter blev fulgt til måned 28 (10 eller 6 måneder efter den sidste henholdsvis rituximabinfusion eller azathioprin-dosis).
English: Although subgroups were small, rituximab maintenance treatment provided a significant benefit in terms of overall survival for both patients responding to CHOP and patients responding to R-CHOP, although longer follow-up is required to confirm this observation.
Danish: Selvom undergrupperne var små gav rituximab vedligeholdelsesbehandling en signifikant fordel i form af samlet overlevelse både for patienter, der responderede på CHOP og for patienter, der responderede på R-CHOP, dog er længere opfølgning nødvendig for at bekræfte denne observation.
English: Non-oncology indications:
Danish: Ikke-onkologiske indikationer:
English: Table 15 Summary of efficacy by baseline autoantibody status Week 24
Danish: Tabel 15 Sammenfatning af effekt baseret på autoantistof-status ved baseline Uge 24
English: Reactions attributed to hypersensitivity have been reported less frequently than those attributed to cytokine release.
Danish: Reaktioner tilskrevet overfølsomhedsreaktioner er rapporteret sjældnere end de, som kan tilskrives cytokin frigørelse.
English: Duration of response * Disease free survival (DFS)**
Danish: Responsvarighed* Sygdomsfri overlevelse (DFS)**
English: The incidence of IRRs declined with subsequent infusions.
Danish: Forekomsten af IRR faldt ved efterfølgende infusioner.
English: You should also tell them about your Ritemvia treatment.
Danish: Du skal også fortælle dem om din Ritemvia-behandling.
English: In most cases, the infusion can be resumed at a 50% reduction in rate (e.g. from 100 mg/h to 50 mg/h) when symptoms have completely resolved.
Danish: I de fleste tilfælde kan infusionen genoptages med en 50 % reduktion i hastigheden (f.eks. fra 100 mg/time til 50 mg/time), når symptomerne er fuldstændigt forsvundet.
English: This medicine may make you more likely to get infections.
Danish: Dette lægemiddel kan øge din risiko for at få infektioner.
English: Data in approximately 180 patients pre-treated with rituximab have demonstrated clinical benefit (including CR) and are supportive for rituximab re-treatment.
Danish: Data fra omtrent 180 patienter, som tidligere var behandlet med rituximab, viste klinisk fordel (inklusiv CR) og understøtter genbehandling med rituximab.
English: Prednisone N=36
Danish: Prednison N = 36
English: If any doubt exists, further evaluation, including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments, should be considered.
Danish: Såfremt der er tvivl, bør yderligere undersøgelser overvejes, såsom MRI-scanning, helst med kontrast, cerebrospinalvæske-test (CSF-test) for JC-viral DNA og gentagne neurologiske vurderinger.
English: • Detailed information on the risk of infections and PML
Danish: • Detaljeret information om risikoen for infektioner og PML
English: Figure 1: Change from baseline of DAS28-ESR by baseline autoantibody status
Danish: Figur 1: Ændring fra DAS28-ESR-baseline baseret på autoantistof-status ved baseline
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of Ritemvia maintenance therapy, up to 5 years.
Danish: For patienter, som kan have højere risiko for recidiv, bør lægen overveje en længerevarende vedligeholdelsebehandling med Ritemvia, i op til 5 år.
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;
Danish: I kliniske studier fik mere end 3.100 patienter mindst en behandlingsserie og blev fulgt i perioder, der varede fra 6 måneder til over 5 år.
English: Name:_______________________ Doctor's
Danish: Dato for seneste infusion:_______________ Dato for første infusion: ________________ Patientens navn: ______________________ Lægens navn: ________________________ Lægens tlf. nr.: _______________________
English: In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the rituximab group.
Danish: I observationsgruppen steg den mediane IgG-koncentration efterfølgende til over den nedre referencegrænse, men forblev konstant i rituximab-gruppen.
English: The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g. cognitive, neurological or psychiatric symptoms).
Danish: Lægen bør især være opmærksom på symptomer, som tyder på PML, og som patienten måske ikke selv er opmærksom på (f.eks. kognitive, neurologiske eller psykiatriske symptomer).
English: All patients in the cyclophosphamide arm received azathioprine maintenance therapy during follow-up.
Danish: Alle patienter i cyclophosphamid-armen fik vedligeholdelsesbehandling med azathioprin under opfølgningen.
English: • If you respond well to treatment, you may be given Ritemvia every 2 or 3 months for two years.
Danish: • Hvis medicinen virker godt hos dig, kan du få Ritemvia hver 2. eller 3. måned i op til 2 år.
English: Since initial improvement of clinical symptoms may be followed by deterioration, these patients should be closely monitored until tumour lysis syndrome and pulmonary infiltration have been resolved or ruled out.
Danish: Da en initial forbedring kan følges af forværring, bør disse patienter monitoreres tæt indtil tumorlysesyndrom og lungeinfiltration er forsvundet eller udelukket.
English: Inhibition of the rate of progressive joint damage was also observed long term.
Danish: Hæmning af hastigheden af ledskadeprogression blev også observeret i længere tid.
English: Cumulative incidence over time of first major relapse
Danish: Kumulative hyppighed over tid til første større recidiv
English: This finding was not supported by a stepwise logistic regression analysis in which the following factors were identified as prognostic factors: histological type, bcl-2 positivity at baseline, resistance to last chemotherapy and bulky disease.
Danish: Dette fund kunne ikke bekræftes af en trinvis logistisk regressionsanalyse i hvilken følgende faktorer blev identificeret som prognostiske faktorer: histologisk type, bcl-2 positivitet ved baseline, resistens overfor sidste kemoterapi og udbredt sygdom.
English: The benefit in terms of PFS was consistently observed in most patient subgroups analysed according to disease risk at baseline (i.e. Binet stages A-C) (Table 10b).
Danish: Fordelen med hensyn til PFS blev konsistent observeret i de fleste patientgrupper, som blev analyseret i forhold til sygdomsrisikoen ved baseline (dvs. Binet stadium A-C) (tabel 10b).
English: See also infusion-related reactions below.
Danish: Se også infusionsrelaterede reaktioner nedenfor.
English: Ritemvia may also cause changes in laboratory tests carried out by your doctor.
Danish: Ritemvia kan også ændre resultaterne på de blodprøver, som lægen har bestilt.
English: • bacterial or viral infections, bronchitis
Danish: • bakterie-eller virusinfektioner, bronkitis
English: There are no data on the safety of rituximab in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
Danish: Der er ingen data om sikkerheden af rituximab til patienter med moderat hjerteinsufficiens (NYHA klasse III) eller alvorlig, ukontrolleret hjertesygdom.