natgillin/translations-raw huggingface dataset:
Resultater for effekt hos patienter behandlet med rituximab, blev analyseret på basis af autoantistofstatus forud for påbegyndt behandling. 
Efficacy outcomes in rituximab treated patients were analysed based on autoantibody status prior to commencing treatment.
En lille andel af patienterne havde forlænget perifer B-celle-depletion, der varede 2 år eller mere efter sidst rituximab-dosis. 
A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of rituximab.
Der er ikke gennemført langtidsstudier på dyr med henblik på vurdering af rituximabs karcinogene potentiale. 
No long-term animal studies have been performed to establish the carcinogenic potential of rituximab.
Det svarer til, hvad der blev opnået efter den første serie med rituximab (12,4 måneder). 
This compares favourably with the TTP achieved after the prior course of rituximab (12.4 months).
Derimod fik tre patienter (1,5 %) cerebrovaskulære hændelser i CHOP-armen, og alle forekom i follow-up-perioden. 
In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Sikkerhedsprofilen for rituximab hos patienter med svær reumatoid artrit (RA) er sammenfattet i afsnittene nedenfor. 
The safety profile of rituximab in patients with moderate to severe rheumatoid arthritis (RA) is summarised in the sections below.
I tilfælde af recidiv kan patienter gives 1.000 mg intravenøst. 
In the event of relapse, patients may receive 1000 mg IV.
Hyppigheden af infektioner, som var alvorlige eller krævede i.v.-antibiotika, var ca. 4 pr. 100 patientår. 
The incidence of infections that were serious or required IV antibiotics, was approximately 4 per 100 patient years.
• Nødvendigheden af at kontrollere for infektioner, for immunsuppression, for tidligere/nuværende medicinering, der påvirker immunsystemet, og for nylige og/eller planlagte vaccinationer før behandling med Ritemvia påbegyndes 
• The need to check, prior to Ritemvia treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Ingen patienter i rituximab-armen havde dødelige bivirkninger. 
No patients in the rituximab arm had fatal adverse events.
• Nødvendigheden af, at patienterne kontakter deres læge, hvis de får symptomer 
• The need for patients to contact their health care professional if symptoms occur
Næsten alle infusionsrelaterede reaktioner var lette til moderate. 
Nearly all infusion-related reactions were mild to moderate.
Denne endelige effektanalyse inkluderede alle randomiserede patienter (197 CHOP, 202 R-CHOP) og den mediane opfølgningsperiode var ca. 31 måneder. 
The final efficacy analysis included all randomised patients (197 CHOP, 202 R-CHOP), and had a median follow-up duration of approximately 31 months.
Tabel 7 Oversigt over effektdata for rituximab vedligeholdelsesbehandling versus observation ved den protokol definerede primær analyse og efter 9 års median opfølgningstid (final analyse) 
Table 7 Overview of efficacy results for rituximab maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Nogle eksempler på disse alvorlige virusinfektioner er infektioner forårsaget af herpesvira (cytomegalovirus, varicella zoster virus og herpes simplex virus), JC virus (progressiv multifokal leukoencefalopati (PML)) og hepatitis C virus. 
Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy (PML)) and hepatitis C virus.
B-celle niveauer i spædbørn efter moderen havde været eksponeret for rituximab, er ikke undersøgt i kliniske studier. 
B cell levels in human neonates following maternal exposure to rituximab have not been studied in clinical trials.
Når Ritemvia gives i kombination med kemoterapi, bør standard dosisreduktioner for de kemoterapeutiske lægemidler anvendes. 
When Ritemvia is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
• svigt af mange organer. 
• multiple-organ failure.
For alle patienter gælder, at infusionen ikke bør startes igen, før alle symptomer er forsvundet, og laboratorieværdier og røntgenfund er normaliserede. 
In all patients, the infusion should not be restarted until complete resolution of all symptoms, and normalisation of laboratory values and chest X-ray findings.
Alder, køn, race og WHO performance status havde ingen effekt på rituximabs farmakokinetik. 
Age, gender and WHO performance status had no effect on the pharmacokinetics of rituximab.
• du nogensinde har haft leverbetændelse eller måske har leverbetændelse nu. 
• you have ever had or might now have a hepatitis infection.
Ritemvia skal anvendes under tæt supervision af erfarent sundhedspersonale i omgivelser, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt (se pkt. 
Ritemvia should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Selvom rituximab ikke er myelosuppressivt ved monoterapi, bør forsigtighed udvises, når det overvejes at behandle patienter med neutrofiltal på < 1,5 x 109/l og/eller trombocyttal på < 75 x 109/l, fordi de kliniske erfaringer hos denne population er begrænsede. 
Although rituximab is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
• smagsforstyrrelser, f.eks. at ting smager anderledes, end de plejer 
• taste problems - such as changes in the way things taste
Forekomst af ADA kan være forbundet med forværring af infusions-eller allergiske reaktioner efter den anden infusion ved efterfølgende behandlingsserier. 
The presence of ADA may be associated with worsening of infusion or allergic reactions after the second infusion of subsequent courses.
• udtalt rødme i ansigtet og andre områder af huden på grund af udvidede blodkar 
• becoming very red in the face and other areas of the skin as a consequence of dilation of the blood vessels
I modsætning til cytokinfrigivelsessyndromet optræder egentlige allergiske reaktioner typisk indenfor minutter efter påbegyndelse af infusionen. 
In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
Hvis der er mistanke om PML, skal behandling seponeres, indtil PML-diagnosen er udelukket. 
If PML is suspected, further dosing must be suspended until PML has been excluded.
B-celle niveauet normaliseredes hos disse dyr indenfor 6 måneder efter fødslen og påvirkede ikke vaccinationsreaktionen. 
B cell counts returned to normal in these animals within 6 months of birth and did not compromise the reaction to immunisation.
Units 2100, 2110, 2010, 2120, 2130 and 2500 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY, Storbritannien 
Units 2100, 2110, 2010, 2120, 2130 and 2500 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY, UK
Præmedicinering og profylaktiske lægemidler 
Premedication and prophylactic medications
CTC og ingen dødsfald, som skyldtes IRR i de kliniske studier. 
There were no CTC Grade 4 IRRs and no deaths due to IRRs in the clinical trials.
Baseret på rituximabs virkningsmekanisme og viden om, at B-celler spiller en vigtig rolle i at vedligeholdelsen af det normale immunrespons, kan patienterne have en øget risiko for at få en infektion efter behandling med rituximab (se pkt. 
Based on the mechanism of action of rituximab and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following rituximab therapy (see section 5.1).
Lægen bør gennemgå patientens vaccinationsstatus og følge gældende vaccinationsvejledninger inden igangsætning af rituximab behandling. 
Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to rituximab therapy.
Antigenet udtrykkes på > 95 % af alle B-celle nonHodgkin-lymfomer. 
The antigen is expressed on > 95% of all B cell non-Hodgkin's lymphomas.
7 inklusive tilfælde med dødelig udgang 
7 includes fatal cases
Figur 3. 
Figure 3:
Det primære effektmål var opnåelse af fuldstændig remission ved måned 6, defineret som en BVAS/WG-score (Birmingham Vasculitis Activity Score for Wegener's Granulomatosis) på 0 og ophørt glukokortikoidbehandling. 
The primary outcome measure was achievement of complete remission at 6 months defined as a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 0, and off glucocorticoid therapy.
Henvisning til en neurolog skal overvejes, hvis det er klinisk relevant. 
Consultation with a neurologist should be considered as clinically indicated.
Ca. 2.400 patienter fik to eller flere behandlingsserier, heraf fik over 1.000 patienter fem eller flere behandlingsserier. 
approximately 2,400 patients received two or more courses of treatment with over 1,000 having received 5 or more courses.
Eftersom maternelt IgG imidlertid udskilles i humanmælk, og rituximab blev detekteret i mælk fra diegivende aber, bør kvinder ikke amme, når de behandles med rituximab og i 12 måneder efter afsluttet rituximab behandling. 
However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with rituximab and for 12 months following rituximab treatment.
Der er ikke observeret uforligeligheder mellem rituximab og polyvinylchlorid eller polyethylen infusionsposer eller infusionssæt. 
No incompatibilities between rituximab and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
Af de patienter, der i starten udelukkende fik methotrexat, fik 81 % rituximab enten som rescue-behandling i ugerne 16-24 eller i forlængelsen af studiet inden uge 56. 
Of the patients originally receiving methotrexate alone, 81% received rituximab either as rescue between weeks 16-24 or in the extension trial, before week 56.
Dog blev der observeret dosisafhængigt farmakologisk B-celle depletion i fostrets lymfatiske organer, hvilket fortsatte efter fødslen og blev fulgt af et fald i IgG niveauet hos de påvirkede nyfødte dyr. 
However, dose-dependent pharmacologic depletion of B cells in the lymphoid organs of the foetuses was observed, which persisted post natally and was accompanied by a decrease in IgG level in the newborn animals affected.
Mulige effektor medierede celle lysis mekanismer inkluderer komplement afhængig cellulær cytotoksicitet (CDC) som et resultat af C1q binding og antistof afhængig cellulær cytotoksicitet (ADCC) medieret ved en eller flere af Fcγ receptorerne på overfladen af granulocytter, makrofager og NK celler. 
Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells.
På dette tidspunkt kan infusionen genoptages, dog ikke med mere end halvdelen af den tidligere infusionshastighed. 
At this time, the infusion can be initially resumed at not more than one-half the previous rate.
Specielle populationer - rituximab kombinationsterapi Ældre (≥ 65 år): 
Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Størstedelen af patienterne var ANCA-positive ved diagnosen eller i løbet af deres sygdomsforløb, havde histologisk bekræftet nekrotiserende små-kar vaskulitis med en klinisk fænotype af GPA/MPA eller nyre-begrænset ANCA-associeret vaskulitis, eller begge. 
The majority of patients were ANCApositive at diagnosis or during the course of their disease; had histologically confirmed necrotizing small-vessel vasculitis with a clinical phenotype of GPA/MPA, or renal limited ANCA-associated vasculitis; or both.
24 timer efter infusion 
hours after infusion
6,11 år 
6.11 years
Ritemvia gives altid i et drop (intravenøs infusion). 
You will always be given Ritemvia as a drip (intravenous infusion).
Hyppigheden af alvorlige infektioner var ca. 25 pr. 100 patientår. 
The rate of serious infections was approximately 25 per 100 patient years.
Den højere hyppighed af neutropeni hos patienter behandlet med rituximab og kemoterapi var dog ikke forbundet med en højere hyppighed af infektioner og infestationer sammenlignet med patienter, som fik kemoterapi alene. 
However, the higher incidence of neutropenia in patients treated with rituximab and chemotherapy was not associated with a higher incidence of infections and infestations compared to patients treated with chemotherapy alone.
Hos patienter med reumatoid artrit fik 283 patienter efterfølgende behandling med et biologisk DMARD efter rituximab. 
In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following rituximab.
Analysen af alle sekundære parametre (responsrate, progresionsfri overlevelse, sygdomsfri overlevelse, varighed af respons) bekræftede behandlingseffekten af R-CHOP i forhold til CHOP. 
The analysis of all secondary parameters (response rates, progression-free survival, disease-free survival, duration of response) verified the treatment effect of R-CHOP compared to CHOP.
• Nødvendigheden af at udlevere patientkortet ved hver infusion 
• The need to provide patients with the Patient Alert Card with each infusion
• Detaljeret information om risikoen for PML, nødvendigheden af at diagnosticere PML i tide og egnede metoder til at diagnosticere PML 
• Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML
EFS - Hændelsesfri overlevelse TTP - Tid til progression eller død PFS - Progressionsfri overlevelse TTF - Tid til behandlingssvigt 
EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
• nerveskader i arme og ben, lammelse af ansigtet 
• nerve damage in arms and legs, paralysed face
Hvis du reagerer godt på behandlingen, kan du få Ritemvia som vedligeholdelsesbehandling. 
If you respond well to treatment, you may be given Ritemvia as a maintenance treatment.
Meget sjældne tilfælde af PML med dødeligt udfald er blevet rapporteret efter anvendelse af rituximab. 
Very rare cases of fatal PML have been reported following the use of rituximab.
I alle disse studier var farmakokinetikken for rituximab proportional med dosis inden for det begrænsede dosisinterval, som blev undersøgt. 
In all these studies, rituximab pharmacokinetics were dose proportional over the limited dose range studied.
Strukturel ledskade blev vurderet radiologisk og udtrykt som ændring i modificeret Total Sharp Score (mTSS) og dets bestanddele erosionsscore og score for ledspalteforsnævring. 
Structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Der forekom infektioner (fortrinsvis bakterielle og virale) hos ca. 30-55 % af patienterne i de kliniske studier hos patienter med NHL samt hos 30-50 % af patienterne i de kliniske studier med CLL. 
Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL
Rituximab er et gensplejset chimerisk muse/humant monoklonalt antistof der repræsenterer et glycosyleret immunglobulin med humane IgG1 konstante regioner og murine light-chain og heavychain variable regionssekvenser. 
Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences.
Studiet viste non-inferioritet af rituximab i forhold til cyclophosphamid med hensyn til fuldstændig remission (CR) ved måned 6 (tabel 16). 
The trial demonstrated non-inferiority of rituximab to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Resultat for sygdomsaktivitet 
Disease activity outcomes
Patienter, som behandles med rituximab, kan vaccineres med ikke-levende vacciner. 
Patients treated with rituximab may receive non-live vaccinations.
Ved anvendelse af Cox regressionsanalyse var risiko for forekomst af progressiv sygdom eller død reduceret med 61 % med rituximab vedligeholdelsesbehandling sammenlignet med observation (95 % konfidensinterval: 45 % - 72 %). 
Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61% with rituximab maintenance treatment when compared to observation (95% CI; 45%-72%).
Rituximab er blevet anvendt til 21 patienter, som havde fået foretaget autolog knoglemarvstransplantation, og til andre risikogrupper med formodet nedsat knoglemarvsfunktion uden at fremkalde myelotoksicitet. 
Rituximab has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Det primære endepunkt var hyppigheden af større recidiver ved måned 28. 
The primary outcome measure was the rate of major relapse at month 28.
Farmakoterapeutisk klassifikation: antineoplastiske, monoklonale antistoffer, ATC kode: L01XC02 
Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC02.
Kaplan-Meier estimeret sandsynlighed for progressionsfrihed ved 12 måneder var 78 % i rituximab vedligeholdelsesgruppen mod 57 % i observationsgruppen. 
Kaplan-Meier estimated progression-free rates at 12 months were 78% in the rituximab maintenance group vs. 57% in the observation group.
Mindre recidiver (ikke livstruende og som ikke involverede større organskader) opstod hos 7 patienter i rituximab-gruppen (12 %) og 8 patienter i azathioprin-gruppen (14 %). 
Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the rituximab group (12%) and eight patients in the azathioprine group (14%).
Hepatitis B-infektioner 
Hepatitis B Infections
Hos patienter behandlet for maligne hæmatologiske sygdomme begyndte B-celleregenerering inden for 6 måneders behandling og vendte normalt tilbage til normale niveauer inden for 12 måneder efter afsluttet behandling, selvom det hos nogle patienter kan tage længere tid (op til en median restitutionstid på 23 måneder efter induktionsbehandling). 
In patients treated for haematological malignancies, B cell recovery began within 6 months of treatment and generally returned to normal levels within 12 months after completion of therapy, although in some patients this may take longer (up to a median recovery time of 23 months post-induction therapy).
Der blev ikke rapporteret om forskelle i hyppigheden af anæmi. 
There were no differences reported for the incidence of anaemia.
Ritemvia indeholder det aktive indholdsstof rituximab. 
Ritemvia contains the active substance “rituximab”.
Patienter med udbredt sygdom havde en højere hyppighed af grad 3/4 bivirkninger end patienter uden udbredt sygdom (25,6 % versus 15,4 %). 
There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6% vs. 15.4%).
Der blev rapporteret om nogle tilfælde af sen neutropeni, som indtraf mere end fire uger efter den sidste rituximab-infusion. 
Some cases of late neutropenia occurring more than four weeks after the last infusion of rituximab were reported.
Studiet viste statistisk signifikante resultater af rituximab og lavdosis prednison over standarddosis prednison ved at opnå CRoff ≥ 2 måneder ved måned 24 hos PV-patienter (se tabel 18). 
The study showed statistically significant results of rituximab and low-dose prednisone over standarddose prednisone in achieving CRoff ≥ 2 months at month 24 in PV patients (see Table 18).
I alt 321 patienter fik behandling (162 patienter fik R-CVP og 159 fik CVP) og blev analyseret for effekt. 
A total of 321 patients (162 R-CVP, 159 CVP) received therapy and were analysed for efficacy.
Alle patienter fik samtidig 60 mg oral prednison på dag 2 til 7 og 30 mg på dag 8 til 14 efter den første infusion. 
All patients received concomitant 60 mg oral prednisone on days 2-7 and 30 mg on days 8-14 following the first infusion.
Der er ikke gennemført specifikke studier til at fastlægge rituximabs effekt på fertilitet. 
Specific studies to determine the effects of rituximab on fertility have not been performed.
Antistoffet fremstilles ved mammalian (kinesisk hamster ovarie) cellesuspensionskultur og renses ved affinitetskromatografi og ionbytning, inklusive specifik viral inaktivering og rensningsprocedurer. 
The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Den kumulative hyppighedskurve viste, at tiden til første større recidiv var længere hos patienter, der blev behandlet med rituximab startende fra måned 2 og blev opretholdt til måned 28 (figur 3). 
The cumulative incidence rate curves showed that time to first major relapse was longer in patients with rituximab starting from month 2 and was maintained up to month 28 (Figure 3).
Patienterne fik 2 x 1.000 mg intravenøs infusion af rituximab eller placebo i kombination med MTX. 
Patients received 2 x 1000 mg intravenous infusions of rituximab or placebo in combination with MTX.
Lægen bør undersøge patienten for at fastslå, om symptomerne tyder på en neurologisk dysfunktion, og hvis det er tilfældet, om symptomerne tyder på PML. 
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Andelen af patienter, der oplevede en infusionsrelateret reaktion var henholdsvis 29 % (11 patienter), 40 % (15 patienter), 13 % (5 patienter) og 10 % (4 patienter) efter den første, anden, tredje og fjerde infusion. 
The proportion of patients experiencing an infusion-related reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively.
Patienter med humant anti-mus antistof (HAMA) eller anti-lægemiddel antistof (ADA) titere kan få allergiske eller overfølsomhedsreaktioner, når de behandles med andre diagnostiske eller terapeutiske monoklonale antistoffer. 
Patients with human anti-mouse antibody (HAMA) or anti-drug antibody (ADA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
Patienter, som en gang har haft leverbetændelse, vil blive omhyggeligt undersøgt af lægen for tegn på denne infektion 
Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection.
Patienter blev ekskluderet fra relaps/refraktær CLL-studiet, hvis de tidligere havde været behandlet med monoklonale antistoffer, eller hvis de var refraktære (defineret som manglende evne til at opnå partiel remission i mindst 6 måneder) over for fludarabin eller enhver anden nukleosidanalog. 
Patients were excluded from the study in relapsed/refractory CLL if they had previously been treated with monoclonal antibodies or if they were refractory (defined as failure to achieve a partial remission for at least 6 months) to fludarabine or any nucleoside analogue.
• Advarsel om risikoen for infektioner og PML, inklusive alle symptomer 
• Warning on the risk of infections and PML, including the symptoms
Sikkerheden ved vaccination med levende, virale vacciner efter behandling med rituximab er ikke undersøgt. 
The safety of immunisation with live viral vaccines following rituximab therapy has not been studied.