natgillin/translations-raw huggingface dataset:
Ved uge 48 var det 2-3 gange mere sandsynligt for seropositive patienter at opnå ACRrespons sammenlignet med seronegative patienter.
At week 48 seropositive patients were 2-3 times more likely to achieve ACR responses compared to seronegative patients.
Rituximab blev givet i kombination med intravenøst glukokortikoid, som kan reducere incidensen og sværhedsgraden af sådanne hændelser.
Rituximab was given in combination with intravenous glucocorticoids which may reduce the incidence and severity of these events.
Tabel 13 Radiologiske resultater ved 1 år i studie 1 (mITT population)
Table 13 Radiographic outcomes at 1 year (mITT population)
Fra måned 12 til måned 18 observeredes 8 tilfælde af relaps i rituximabgruppen sammenlignet med 4 i cyclophosphamid-gruppen.
From month 12 to month 18, 8 relapses were observed in the rituximab group compared with four in the cyclophosphamide group.
For patienter randomiseret til vedligeholdelsesdelen af studiet var den mediane observationstid 28 måneder fra vedligeholdelsesrandomiseringen.
For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Der blev set en statistisk signifikant korrelation mellem responsrate og involvering af knoglemarven.
A statistically significant correlation was noted between response rates and bone marrow involvement.
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.
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.
Du får Ritemvia af en læge eller sygeplejerske med erfaring i denne behandling.
Ritemvia will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Kvalificerede patienter havde aktiv reumatoid artrit diagnosticeret ifølge kriterierne fra American College of Rheumatology (ACR).
Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR).
Ritemvias sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
The safety and efficacy of Ritemvia in children below 18 years has not been established.
Nedtitrering af prednison skulle være gennemført 6 måneder efter start af studiebehandling.
Prednisone tapering was to be completed by 6 months from the start of study treatment.
Gentagne behandlingsforløb med Ritemvia er mulige.
Repeated treatment courses with Ritemvia are possible.
Immunomodulerende lægemidler kan øge risikoen for maligne sygdomme.
Immunomodulatory medicinal products may increase the risk of malignancy.
Farmakokinetisk analyse af populationen viste, at legemsoverflade og køn var de mest signifikante co-variable, til forklaring af inter-individuel variation i farmakokinetiske parametre.
Population pharmacokinetic analysis revealed that BSA and gender were the most significant covariates to explain inter-individual variability in pharmacokinetic parameters.
Der blev observeret effekt både hos nyligt diagnosticerede patienter og hos patienter med recidiverende sygdom (tabel 17).
Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing disease (Table 17).
Prednison dosis nedtitrering og beslutningen om at stoppe prednison-behandling efter måned 18 var op til investigators skøn.
Prednisone dose tapering and the decision to stop prednisone treatment after month 18 were left at the investigator's discretion.
Hos CLL-patienter forventes lignede resultater, når lighederne mellem sygdommene tages i betragtning, men det er ikke undersøgt i kliniske studier.
For CLL patients similar results are assumable considering similarities between both diseases but that has not been investigated in clinical trials.
Hvad er symptomerne på en infektion?
What are the signs of getting an infection?
Infusionsrelaterede reaktioner kan forekomme som følge af hypersensitivitet og/eller virkningsmekanismen.
IRRs may occur as a result of hypersensitivity and/or to the mechanism of action.
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.
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.
• 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
• 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.
Seropositive patienter havde desuden et signifikant større fald i DAS28-ESR sammenlignet med seronegative patienter (figur 1).
Seropositive patients also had a significantly greater decrease in DAS28-ESR compared to seronegative patients (Figure 1).
Dato for behandlingsstart og kontaktoplysninger
Treatment start date and contact details
Den mediane PFS var 42,2 måneder i rituximab vedligeholdelsesarmen sammenlignet med 14,3 måneder i observationsarmen.
The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
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)
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)
Andelen af patienter, som oplevede kardielle bivirkninger (alle eller alvorlige), steg ikke ved gentagne behandlingsserier.
The proportions of patients experiencing cardiac reactions (all or serious) did not increase over multiple courses.
• langvarig depression
• long lasting depression
Din læge kan ordinere Ritemvia til behandling for:
Your doctor may prescribe Ritemvia for the treatment of:
Epistaxis Nasal congestion
Dyspnoea Epistaxis Nasal congestion
Sjældent har nogle af disse bivirkninger været dødelige.
Rarely, some of these reactions have been fatal.
Alle patienter blev fulgt til måned 28 (10 eller 6 måneder efter den sidste henholdsvis rituximabinfusion eller azathioprin-dosis).
All patients were followed until month 28 (10 or 6 months, respectively, after the last rituximab infusion or azathioprine dose).
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.
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.
Ikke-onkologiske indikationer:
Non-oncology indications:
Tabel 15 Sammenfatning af effekt baseret på autoantistof-status ved baseline Uge 24
Table 15 Summary of efficacy by baseline autoantibody status Week 24
Reaktioner tilskrevet overfølsomhedsreaktioner er rapporteret sjældnere end de, som kan tilskrives cytokin frigørelse.
Reactions attributed to hypersensitivity have been reported less frequently than those attributed to cytokine release.
Responsvarighed* Sygdomsfri overlevelse (DFS)**
Duration of response * Disease free survival (DFS)**
Forekomsten af IRR faldt ved efterfølgende infusioner.
The incidence of IRRs declined with subsequent infusions.
Du skal også fortælle dem om din Ritemvia-behandling.
You should also tell them about your Ritemvia treatment.
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.
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.
Dette lægemiddel kan øge din risiko for at få infektioner.
This medicine may make you more likely to get infections.
Data fra omtrent 180 patienter, som tidligere var behandlet med rituximab, viste klinisk fordel (inklusiv CR) og understøtter genbehandling med rituximab.
Data in approximately 180 patients pre-treated with rituximab have demonstrated clinical benefit (including CR) and are supportive for rituximab re-treatment.
Prednison N = 36
Prednisone N=36
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.
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.
• Detaljeret information om risikoen for infektioner og PML
• Detailed information on the risk of infections and PML
Figur 1: Ændring fra DAS28-ESR-baseline baseret på autoantistof-status ved baseline
Figure 1: Change from baseline of DAS28-ESR by baseline autoantibody status
For patienter, som kan have højere risiko for recidiv, bør lægen overveje en længerevarende vedligeholdelsebehandling med Ritemvia, i op til 5 år.
For patients who may be at higher risk for relapse, physicians should consider a longer duration of Ritemvia maintenance therapy, up to 5 years.
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.
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;
Dato for seneste infusion:_______________ Dato for første infusion: ________________ Patientens navn: ______________________ Lægens navn: ________________________ Lægens tlf. nr.: _______________________
Name:_______________________ Doctor's
I observationsgruppen steg den mediane IgG-koncentration efterfølgende til over den nedre referencegrænse, men forblev konstant i rituximab-gruppen.
In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the rituximab group.
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).
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g. cognitive, neurological or psychiatric symptoms).
Alle patienter i cyclophosphamid-armen fik vedligeholdelsesbehandling med azathioprin under opfølgningen.
All patients in the cyclophosphamide arm received azathioprine maintenance therapy during follow-up.
• Hvis medicinen virker godt hos dig, kan du få Ritemvia hver 2. eller 3. måned i op til 2 år.
• If you respond well to treatment, you may be given Ritemvia every 2 or 3 months for two years.
Da en initial forbedring kan følges af forværring, bør disse patienter monitoreres tæt indtil tumorlysesyndrom og lungeinfiltration er forsvundet eller udelukket.
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.
Hæmning af hastigheden af ledskadeprogression blev også observeret i længere tid.
Inhibition of the rate of progressive joint damage was also observed long term.
Kumulative hyppighed over tid til første større recidiv
Cumulative incidence over time of first major relapse
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.
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.
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).
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).
Se også infusionsrelaterede reaktioner nedenfor.
See also infusion-related reactions below.
Ritemvia kan også ændre resultaterne på de blodprøver, som lægen har bestilt.
Ritemvia may also cause changes in laboratory tests carried out by your doctor.
• bakterie-eller virusinfektioner, bronkitis
• bacterial or viral infections, bronchitis
Der er ingen data om sikkerheden af rituximab til patienter med moderat hjerteinsufficiens (NYHA klasse III) eller alvorlig, ukontrolleret hjertesygdom.
There are no data on the safety of rituximab in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
På tværs af alle udviklingsstudier var udbyttet af behandlingen sammenlignelig hos patienterne uafhængigt af alder, køn, legemsoverfladeareal, race, antal tidligere behandlinger eller sygdomsstatus.
Across all development studies the treatment benefit was similar in patients independent of age, gender, body surface area, race, number of prior treatments or disease status.
Bivirkningerne er angivet i tabel 2.
Adverse reactions are listed in Table 2.
40 % af patienterne med involvering af knoglemarven responderede sammenlignet med 59 % af patienterne uden involvering af knoglemarven (p = 0,0186).
40% of patients with bone marrow involvement responded compared to 59% of patients with no bone marrow involvement (p=0.0186).
Primær analyse (median opfølgning: 25 måneder)
Primary analysis (median FU: 25 months)
Andelen af patienter med IgG-niveauer under den nedre referenceramme var ca. 60 % i rituximab gruppen i hele behandlingsperioden på 2 år, hvorimod den faldt i observationsgruppen (36 % efter 2 år).
The proportion of patients with IgG levels below the LLN was about 60% in the rituximab group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Rituximab kunne detekteres i patienternes serum i op til 3-6 måneder efter færdiggørelse af den sidste behandling.
Rituximab was detectable in the serum of patients 3 - 6 months after completion of last treatment.
Forekom på forskellige tidspunkter op til flere måneder efter afslutningen af behandlingen med rituximab
Occurred at various times up to several months after completion of rituximab therapy
Der forekom svære infusionsrelaterede reaktioner (som f.eks. bronkospasmer eller hypotension) i op til 12 % af tilfældene.
Severe infusion-related reactions (such as bronchospasm, hypotension) occurred in up to 12% of the cases.
Tre patienter havde fået 2 serier med rituximab før inklusion og fik således den tredje serie i studiet.
Three of the patients had received two courses of rituximab before enrolment and thus were given a third course in the study.
Der blev observeret vedvarende forbedring af fysisk funktion angivet ved HAQ-DI-score og andelen af patienter, som opnåede MCID for HAQ-DI.
Sustained improvement in physical function as indicated by the HAQ-DI score and the proportion of patients achieving MCID for HAQ-DI were observed.
Hvis de samme alvorlige bivirkninger forekommer igen, bør man i hvert enkelt tilfælde alvorligt overveje at tage beslutning om at stoppe behandlingen.
If the same severe adverse reactions occur for a second time, the decision to stop the treatment should be seriously considered on a case by case basis.
• smerter i muskler eller hænder og fødder
• pain in the muscles or in the hands or feet
Median TTF/PFS/ EFS måneder
Median TTF/PFS/ EFS mo
Det vides ikke, om Ritemvia påvirker din evne til at køre motorkøretøj eller arbejde med maskiner.
It is not known whether Ritemvia has an effect on you being able to drive or use any tools or machines.
• om du nogensinde har fået medicin, der påvirker immunforsvaret, f.eks. kemoterapi eller medicin, der nedsætter immunforsvaret.
• if you have ever taken medicines which affect your immune system - such as chemotherapy or immune-suppressive medicines.
PML, reaktivering af hepatitis B
PML, reactivation of hepatitis B
På baggrund af standardiserede incidensratioer synes malignitetshyppigheden at svare til den, der tidligere er indberettet hos patienter med ANCA-associeret vaskulitis.
On the basis of standardised incidence ratios, the incidence of malignancies appears to be similar to that previously reported in patients with ANCA-associated vasculitis.
Rituximab inducerede B-cellereduktion hos 70 % til 80 % af patienterne, men blev kun ledsaget af nedsat serum-immunglobulin hos en mindre del af patienterne.
Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Bland opløsningen ved at vende posen forsigtigt for at undgå skumdannelse.
For mixing the solution, gently invert the bag in order to avoid foaming.
Der er ikke foretaget studier af rituximabs indflydelse på evnen til at føre bil og betjene maskiner, men den farmakologiske virkning og de indtil dato rapporterede bivirkninger tyder på, at rituximab ikke, eller kun i ubetydelig grad, påvirker evnen til at føre motorkøretøj og betjene maskiner.
No studies on the effects of rituximab on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that rituximab would have no or negligible influence on the ability to drive and use machines.
Denne analyse antyder, at doseringsjusteringer for rituximab baseret på de testede variable ikke forventes at give en relevant reduktion i den farmakokinetiske variation.
This analysis suggests that dose adjustment of rituximab with any of the tested covariates is not expected to result in a meaningful reduction in its pharmacokinetic variability.
Patienter med højere CD-19 positive celletal og eller tumorbyrde havde en højere CL2.
Patients with higher CD19-positive cell counts or tumour lesions had a higher CL2.
Inkluderede patienter var 21 til 75 år og havde nyligt diagnosticeret eller recidiverende sygdom i fuldstændig remission efter kombineret behandling med glukokortikoider og pulsbehandling med cyclophosphamid.
Included patients were 21 to 75 years of age and had newly diagnosed or relapsing disease in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide.
Ritemvia indeholder natrium
Ritemvia contains sodium
• forhøjet blodtryk
• raised blood pressure
Behandlingsforskel (rituximabcyclophosphamid)
Treatment difference (Rituximabcyclophosphamide)
• genopblussen af tidligere hepatitis B-infektion c) Hvis du behandles for pemfigus vulgaris
• recurrence of a previous Hepatitis B infection c) If you are being treated for pemphigus vulgaris
• ændringer i hjerterytmen, eller hjertet slår hurtigere end normalt
• changes in the rhythm of the heart, or the heart beating faster than normal
Det vil ofte dreje sig om forkølelser, men der har været tilfælde af lungebetændelse og urinvejsinfektioner.
These are often colds, but there have been cases of pneumonia or urinary infections.
Cellerne, der påvirkes af Ritemvia hjælper med at bekæmpe infektioner, og du bør vente med behandling med Ritemvia, indtil infektionen er forsvundet.
The cells that are affected by Ritemvia help to fight infection and you should wait until the infection has passed before you are given Ritemvia.
Disse studier understøtter anvendelse af rituximab sammen med enhver kemoterapi.
These studies support the use of rituximab with any chemotherapy.
Alle infusionsrelaterede reaktioner var af CTC-grad 1 eller 2.
All IRRs were CTC Grade 1 or 2.
En vedligeholdelsesinfusion på 500 mg intravenøst skal administreres ved måned 12 og 18, og derefter hver 6. måned efter behov, baseret på den kliniske vurdering.
A maintenance infusion of 500 mg IV should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation.
Onkologi-indikationer:
Oncology indications:
Fortæl det øjeblikkeligt til lægen, hvis du oplever nogen af disse symptomer.
Tell your doctor immediately if you have any of these symptoms.
Det respiratoriske system Tilfælde af interstitiel lungesygdom, hvoraf nogle med dødelig udgang, er blevet rapporteret.
Respiratory system Cases of interstitial lung disease, some with fatal outcome, have been reported.
Farmakokinetisk analyse af populationen af de samme data gav sammenlignelige gennemsnitlige værdier for systemisk clearance og halveringstid; henholdsvis 0,26 l/dag og 20,4 dage.
Population pharmacokinetic analysis of the same data gave similar mean values for systemic clearance and half-life, 0.26 L/day and 20.4 days, respectively.
Rituximab vedligeholdelsesbehandling reducerede risikoen for død med 56 % (95 % konfidensinterval: 22 % - 75 %).
Rituximab maintenance treatment reduced the risk of death by 56% (95% CI; 22%-75%).
Det vides ikke om rituximab udskilles i humanmælk.
Whether rituximab is excreted in human milk is not known.
Patienter med positiv hepatitis B-serologi (enten HBsAg eller HBcAb) bør inden påbegyndelse af behandling konsultere en specialist i leversygdomme og bør overvåges og behandles i henhold til lokale kliniske standarder for at forebygge hepatitis B-reaktivering.
Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Hos patienter, som udvikler tegn på alvorlige reaktioner, især alvorlig dyspnø, bronkospasme eller hypoxi, skal infusionen straks afbrydes.
Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately.
Pneumocystis jirovecii pneumoni profylakse var påkrævet for alle patienter med CD4+ T-lymfocyttal lavere end 250 pr. kubikmillimeter.
Pneumocystis jirovecii pneumonia prophylaxis was required for all patients with CD4+ T-lymphocyte counts less than 250 per cubic millimeter.
1 Hyppigheden stammer fra laboratorie-værdier, som var indsamlet som en del af rutinemæssig laboratorie-overvågning i kliniske studier 2 Hyppigheden stammer fra data efter markedsføring
1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials 2 Frequency category derived from post-marketing data.
Svært immunkompromitterede patienter.
Patients in a severely immunocompromised state.
Afhængig af sværhedsgraden af de infusionsrelaterede reaktioner og de nødvendige indgreb, skal rituximab-behandlingen midlertidigt eller permanent afbrydes.
Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue rituximab.
3 Reaktioner, som forekommer inden for 24 timer efter infusion.
3 Reactions occurring during or within 24 hours of infusion.
Patienter, der rapporterer signaler og symptomer på infektion efter behandling med rituximab bør straks undersøges og behandles som nødvendigt.
Patients reporting signs and symptoms of infection following rituximab therapy should be promptly evaluated and treated appropriately.
Aktive, alvorlige infektioner (se pkt.
Active, severe infections (see section 4.4).
Gentagne behandlingsserier er forbundet med en bivirkningsprofil, som ligner den, som observeres efter første eksponering.
Multiple courses of treatment are associated with a similar ADR profile to that observed following first exposure.