natgillin/translations-raw huggingface dataset:
Opbevares i den ydre karton for at beskytte mod lys.
Keep the container in the outer carton, in order to protect from light.
I rituximab-gruppen opnåede 48 % af patienterne fuldstændig remission ved måned 12, og 39 % af patienterne opnåede fuldstændig remission ved måned 18.
In the rituximab group, 48% of patients achieved CR at 12 months, and 39% of patients achieved CR at 18 months.
Kliniske fund ved anafylaksi kan ligne de kliniske fund på cytokinfrigivelsessyndrom (beskrevet ovenfor).
Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Vaccinationerne bør være gennemført senest 4 uger inden første dosis af rituximab.
Vaccination should be completed at least 4 weeks prior to first administration of rituximab.
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
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
Hvis en patient udvikler PML, skal behandlingen med rituximab seponeres permanent.
If a patient develops PML, the dosing of rituximab must be permanently discontinued.
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.
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.
Der bør altid gives præmedicin bestående af et anti-pyretisk lægemiddel samt et antihistamin, f.eks. paracetamol og diphenhydramin, inden hver Ritemvia-administration.
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Ritemvia.
Medicin, der gives inden hver behandling med Ritemvia
Medicines given before each Ritemvia administration
Natriumchlorid Trinatriumcitratdihydrat Polysorbat 80
Sodium chloride Tri-sodium citrate dihydrate Polysorbate 80
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.
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.
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.
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.
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.
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.
Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som kan forventes at udskrive Ritemvia, har modtaget følgende:
The MAH must ensure that all physicians who are expected to prescribe Ritemvia are provided with the following:
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).
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).
Pakning med 2 hætteglas.
Pack of 2 vials.
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.
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.
Sikkerhedsinformationen, som er samlet efter markedsføring, afspejler den forventede bivirkningsprofil, dvs. den som blev set i kliniske studier med rituximab (se pkt.
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).
• infektioner som f.eks. herpesudbrud og øjeninfektion
• infections such as herpes infections and eye infection
Tre havde ingen rapporterede bivirkninger.
Three cases had no reported adverse event.
Rituximabs sikkerhedsprofil ved non-Hodgkin-lymfom og CLL er baseret på data fra patienter fra kliniske studier og fra post-marketing overvågning.
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.
Infektionerne var overvejende lette til moderate.
Infections were predominately mild to moderate.
Den samlede responsrate efter behandlingsserie 8 var 76,2 % i R-CHOP gruppen sammenlignet med 62,4 % i CHOP gruppen (p = 0,0028).
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).
Handelsnavnet og batchnummer på det anvendte produkt skal registreres (eller anføres) tydeligt i patientens journal for at sikre sporbarheden af biologiske lægemidler.
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.
Tabel 6 Opsummering af nøgleresultater fra fire fase-III-randomiserede studier, der evaluerer fordelene ved rituximab med forskellige kemoterapibehandlinger ved follikulært lymfom
Table 6 Summary of key results from four phase III randomised studies evaluating the benefit of rituximab with different chemotherapy regimens in follicular lymphoma
Prednison-behandlingen blev nedtitreret og holdt på en lav dosis (cirka 5 mg pr. dag) i mindst 18 måneder efter randomiseringen.
Prednisone treatment was tapered and then kept at a low dose (approximately 5 mg per day) for at least 18 months after randomization.
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.
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.
Konsekvenserne af B-celle-depletion over lang tid hos pædiatriske patienter kendes ikke.
The consequences of long-term B cell depletion in paediatric patients are unknown.
Tabel 12 Resultater for klinisk respons ved det primære endepunkt i studie 1 (ITT populationen)
Table 12 Clinical response outcomes at primary endpoint in Trial 1 (ITT population)
Svær (grad 3/4) neutropeni forekom hos 4,2 % af patienterne, svær anæmi hos 1,1 %, og svær trombocytopeni hos 1,7 %.
Severe (grade 3/4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Rituximab bindes specifikt til det transmembrane antigen, CD20, et non-glycosyleret phosphoprotein som findes på præ-B og modne B-lymfocytter.
Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Dette kan hovedsageligt tilskrives infusionsrelaterede reaktioner (hyppigst under første behandlingsserie), reumatoid artrit-eksacerbation og infektioner, som alle var hyppigere i de første 6 måneder af behandlingen.
This is mostly accounted for by IRRs (most frequent during the first treatment course), RA exacerbation and infections all of which were more frequent in the first 6 months of treatment.
• allergiske reaktioner, som normalt forekommer under infusionen, men kan forekomme i op til 24 timer efter infusion
• allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
Hændelsesfri overlevelse Responsrate (CR, nPR eller PR)
Event free survival Response rate (CR, nPR, or PR)
Ritemvia bør gives på dag 1 i hver kemoterapiserie, efter intravenøs indgift af glukokortikoidkomponenten, hvis det anvendes.
Ritemvia should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Rituximab blev administreret som to i.v.-infusioner med et interval på 15 dage.
Rituximab was administered as two IV infusions separated by an interval of 15 days.
Ritemvia har i sjældne tilfælde forårsaget en alvorlig hjerneinfektion, som kaldes ”Progressiv multifokal leukoencefalopati” (PML).
Rarely Ritemvia can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Neutropeni kan forekomme flere måneder efter indgivelse af rituximab (se pkt.
Neutropenia can occur several months after the administration of rituximab (see section 4.4).
Den højeste intravenøse rituximab-dosis, der til dato er testet hos mennesker, er 5.000 mg (2.250 mg/m2), som er testet i et dosis-eskaleringsstudie med patienter med kronisk lymfocytisk leukæmi.
The highest intravenous dose of rituximab tested in humans to date is 5000 mg (2250 mg/m2), tested in a dose escalation study in patients with CLL.
Prævention hos mænd og kvinder
Contraception in males and females
Rituximab er vist at være yderst specifikt overfor CD20 antigenet på B-celler.
Rituximab has shown to be highly specific to the CD20 antigen on B cells.
Neutropeni var ikke forbundet med en øget frekvens af alvorlige infektioner blandt rituximabbehandlede patienter.
Neutropenia was not associated with an observed increase in serious infection in rituximab-treated patients.
Rituximab vedligeholdelsesbehandling gav konsekvent fordel i alle testede prædefinerede undergrupper: Køn (mand, kvinde), alder (< 60 år, ≥ 60 år), FLIPI-score (≤ 1, 2 eller ≥ 3), induktionsbehandling (R-CHOP, R-CVP eller R-FCM) og uanset kvaliteten af respons på induktionsbehandling (CR, CRu eller PR).
Rituximab maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, ≥ 60 years), FLIPI score (≤1, 2 or ≥ 3), induction therapy (RCHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
Infusionsrelaterede reaktioner*
Infusion-related reactions*
Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
For storage conditions after dilution of the medicinal product, see section 6.3.
Svimmelhed Tremor
Dizziness Tremor
Rituximab-vedligeholdelsesbehandling forlængede signifikant den mediane PFS hos patienter, der responderede på CHOP-induktionsbehandling (median PFS 37,5 måneder versus 11,6 måneder, p< 0,0001) såvel som hos dem, der responderede på R-CHOP induktionsbehandling (median PFS 51,9 måneder versus 22,1 måneder, p = 0,0071).
Rituximab maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p< 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Det binder sig til overfladen på de hvide blodlegemer, der kaldes B-lymfocytter.
It sticks to the surface of a type of white blood cell called “B-Lymphocyte”.
• Nødvendigheden af at advare patienterne om risikoen for infektioner og PML, inklusive symptomerne, så patienterne kender disse og er klar over, at de straks skal kontakte deres læge, hvis de oplever nogen symptomer
• The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.
Antallet af respondenter (respons-rate (%))
EULAR Response (%)
I det kliniske studie med vedligeholdelsesbehandling blev ingen klinisk relevante forskelle observeret mellem de to behandlingsarme eller i fald af total immunoglobulin, IgG-, IgM- eller IgA-niveauer under studiet.
In the maintenance therapy clinical trial, no clinically meaningful differences between the two treatment arms or decreases in total immunoglobulin, IgG, IgM or IgA levels were observed throughout the trial.
ap-værdi er fra Fisher's exact test med mid-p korrektion b95 % konfidensinterval er korrigeret Newcombe interval
Number of responders (response rate [%]) a p-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Resultaterne fra tre andre randomiserede studier, hvor rituximab blev anvendt i kombination med andre kemoterapibehandlinger end CVP (CHOP, MCP, CHVP/Interferon-α), har også vist signifikante forbedringer i responsrater, tidsafhængige parametre samt samlet overlevelse.
Results from three other randomised trials using rituximab in combination with chemotherapy regimen other than CVP (CHOP, MCP, CHVP/Interferon-α) have also demonstrated significant improvements in response rates, time-dependent parameters as well as in overall survival.
Efter induktion af remission med Ritemvia skal vedligeholdelsesbehandling initieres tidligst 16 uger efter sidste Ritemvia infusion.
Following induction of remission with Ritemvia, maintenance treatment should be initiated no sooner than 16 weeks after the last Ritemvia infusion.
I behandlingsperioden (induktionsbehandlingsfasen bestående af R-CHOP i højst 8 behandlingsserier) fik fire patienter (2 %) i R-CHOP-armen, alle med kardiovaskulære risikofaktorer, tromboemboliske cerebrovaskulære hændelser i den første behandlingsserie.
During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles), four patients (2%) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Den overordnede sikkerhedsprofil var i overensstemmelse med den i forvejen fastlagte sikkerhedsprofil for rituximab i rheumatoid artrit og GPA/MPA, og ingen nye bivirkninger blev rapporteret.
The overall safety profile was consistent with the well-established safety profile of rituximab in RA and GPA/MPA and no new adverse drug reactions were reported.
Cytokinfrigivelsessyndrom kan klinisk være umuligt at skelne fra akutte overfølsomhedsreaktioner.
Cytokine release syndrome may be clinically indistinguishable from acute hypersensitivity reactions.
Tabel 18 Procentdel af patienter med PV, som opnåede fuldstændig remission uden kortikoid-behandling i to eller flere måneder ved måned 24 (ITT-populationPV)
Table 18 Percentage of PV patients who achieved complete remission off corticosteroid therapy for two months or more at month 24 (Intent-to-Treat Population - PV)
Risikoreduktion1)
Risk reduction1)
Hæmatologisk toksicitet
Haematological toxicities
Hvis du behandles for granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris vil du også finde denne information i patientkortet, som du har fået af lægen.
If you are being treated for granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor.
Vedvarende depressiv lidelse Svær depression Irritabilitet
Persistent depressive disorder Major depression Irritability
De i alt 334 patienter, der opnåede komplet eller partiel remission efter induktionsbehandlingen, blev efterfølgende randomiseret til rituximab-vedligeholdelsesbehandling (n = 167) eller observation (n = 167).
A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to rituximab maintenance therapy (n=167) or observation (n=167).
I de rapporterede tilfælde var der kendte risikofaktorer for PRES/RPLS, herunder patientens underliggende sygdom, hypertension, immunsuppressiv behandling og/eller kemoterapi.
The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Det vides, at IgG-immunglobuliner kan passere placentabarrieren.
IgG immunoglobulins are known to cross the placental barrier.
Hyppigheden af alvorlige kardielle bivirkninger var 2,1 pr. 100 patientår (95 % konfidensinterval 3-15).
The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3-15).
Den mest almindelige, alvorlige infektion rapporteret i rituximab-gruppen var let eller moderat bronkitis.
The most commonly reported serious infection in the rituximab group was mild or moderate bronchitis.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med rituximab i alle undergrupper af den pædiatriske population med autoimmun artrit (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with autoimmune arthritis.
En vedligeholdelsesinfusion af rituximab 500 mg blev administreret ved måned 12 og 18.
Maintenance infusions of rituximab 500 mg were administered at months 12 and 18.
Fortæl din læge eller sygeplejerske, hvis du får eller tidligere har fået medicin, som kan påvirke dit immunsystem.
Tell your doctor or nurse if you are taking or have previously taken medicines which may affect your immune system this includes chemo-therapy.
Incidensen, typen og sværhedsgraden af infusionsrelaterede reaktioner var konsistent med, hvad der tidligere var observeret.
The incidence, types and severity of IRRs were consistent with that observed historically.
Patienter i rituximab-gruppen, som oplevede recidiv, kunne få en yderligere infusion med rituximab 1.000 mg i kombination med genindført eller optitreret prednison-dosis.
Patients in the rituximab group who relapsed could receive an additional infusion of rituximab 1000 mg in combination with reintroduced or escalated prednisone dose.
Median EFS: 36 Ikke opnået p < 0,0001
Median EFS: 36 Not reached p < 0.0001
Information til patienten
Patient information
Efter en median observationstid på 31 måneder for patienter randomiseret til induktionsfasen forbedrede R-CHOP signifikant udfaldet af recidiveret/ refraktært follikulært lymfom i sammenligning med CHOP (se tabel 8).
After a median observation time of 31 months for patients randomised to the induction phase, R-CHOP significantly improved the outcome of patients with relapsed/refractory follicular lymphoma when compared to CHOP (see Table 8).
Muskuloskeletal smerte
Musculoskeletal pain
Diagnosen PRES / RPLS kræver bekræftelse ved en hjernescanning.
A diagnosis of PRES/RPLS requires confirmation by brain imaging.
Den samlede hyppighed af infektioner var ca. 94 pr. 100 patientår hos patienter behandlet med rituximab.
The overall rate of infection was approximately 94 per 100 patient years in rituximab treated patients.
Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, Storbritannien
Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, UK
Gennemsnittet af præterapeutiske antistoftitere for et udvalg af antigener (Streptococcus pneumoniae, influenza A, mæslinger, røde hunde, skoldkopper) blev bibeholdt i mindst 6 måneder efter behandling med rituximab.
Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with rituximab.
Kaplan-Meier estimat for den mediane tid til hændelsen (måneder)
Kaplan-Meier estimate of median time to event (months)
Det skal du vide, før du begynder at få Ritemvia Du må ikke få Ritemvia, hvis:
What you need to know before you use Ritemvia Do not take Ritemvia if:
Patientkortet for Ritemvia for non-onkologiske indikationer skal indeholde følgende nøgle-elementer:
The Patient Alert Card for Ritemvia in non-oncology indications should contain the following key elements:
Bivirkningerne omfattede fortrinsvis feber, kulderystelser og rigor.
These symptoms mainly comprised fever, chills and rigors.
De hyppigst rapporterede bivirkninger var takykardi (4 %) og atrieflimren (3 %) (se pkt.
The most frequently reported events were tachycardia (4%) and atrial fibrillation (3%) (see section 4.4).
4,04 år
4.04 years
I et studie designet til at evaluere sikkerheden af en hurtigere rituximab-infusion hos patienter med reumatoid artrit kunne patienter med moderat til svær aktiv reumatoid artrit, som ikke havde oplevet en alvorlig infusionsrelateret reaktion under eller inden for 24 timer efter deres første infusion, få en 2 timers intravenøs rituximab-infusion.
In a trial designed to evaluate the safety of a more rapid rituximab infusion in patients with rheumatoid arthritis, patients with moderate-to-severe active RA who did not experience a serious IRR during or within 24 hours of their first studied infusion were allowed to receive a 2-hour intravenous infusion of rituximab.
Ritemvia er indiceret til behandling af tidligere ubehandlede patienter med stadium III-IV follikulært lymfom i kombination med kemoterapi.
Ritemvia is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Cyclophosphamid (n = 98)
Cyclophosphamide (n = 98)
Patienter med tidligere lungesvigt eller patienter med pulmonal tumor infiltration kan have større risiko for ikke at tåle behandlingen og bør behandles med ekstra forsigtighed.
Patients with a history of pulmonary insufficiency or those with pulmonary tumour infiltration may be at greater risk of poor outcome and should be treated with increased caution.
Neutrofiltælling bør foretages inden hver rituximab behandlingsserie og regelmæssigt op til 6 måneder efter afsluttet behandling, samt ved tegn på infektion (se pkt.
Measure blood neutrophils prior to each course of rituximab, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
kraniel neuropati, tab af andre sanser5
cranial neuropathy, loss of other senses5
Analyse af samlet overlevelse viste fortsat en signifikant fordel ved R-FC-behandling i forhold til FCkemoterapi (p = 0,0319, log-rank test) (tabel 10a).
The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p=0.0319, log-rank test) (Table 10a).
Median PFS: 28,8 Ikke opnået p < 0,0001
Median PFS: 28.8 Not reached p < 0.0001
Det akutte respirationssvigt kan ledsages af f.eks. interstitiel lungeinfiltration eller lungeødem som kan ses på røntgen af thorax.
The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest X-ray.