natgillin/translations-raw huggingface dataset:
I alt 117 patienter (88 med GPA, 24 med MPA og 5 med nyre-begrænset antineutrofil cytoplasmisk antistof (ANCA)-associeret vaskulitis) i sygdomsremission blev randomiseret til at få henholdsvis azathioprin (59 patienter) eller rituximab (58 patienter) i et prospektiv, kontrolleret, åbent multicenterstudie.
A total of 117 patients (88 with GPA, 24 with MPA, and 5 with renal-limited ANCA-associated vasculitis) in disease remission were randomised to receive azathioprine (59 patients) or rituximab (58 patients) in a prospective, multi-center, controlled, open-label study.
Resultater fra andre støttende studier, som anvendte rituximab i kombination med andre kemoterapiregimer (herunder CHOP, FCM, PC og PCM, bendamustin og cladribin) til behandling af tidligere ubehandlede og/eller relaps/refraktære CLL-patienter, har også vist høje totale responsrater med fordele i form af PFS-rater om end med moderat højere toksicitet (specielt myelotoksicitet).
Results from other supportive studies using rituximab in combination with other chemotherapy regimens (including CHOP, FCM, PC, PCM, bendamustine and cladribine) for the treatment of previously untreated and/or relapsed/refractory CLL patients have also demonstrated high overall response rates with benefit in terms of PFS rates, albeit with modestly higher toxicity (especially myelotoxicity).
Andelen af patienter behandlet med rituximab, som viste minimal klinisk relevant ændring (MCID) i HAQ-DI (defineret som et fald i individuel total score på > 0,22) var også højere end hos patienter, som fik methotrexat alene (tabel 14).
The proportions of rituximab treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of >0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Patienter skal nøje monitoreres for cytokinfrigivelsessyndrom (se pkt.
Patients should be closely monitored for the onset of cytokine release syndrome (see section 4.4).
Efterfølgende infusioner skal ikke administreres senere end 16 uger efter den tidligere infusion.
Subsequent infusions may be administered no sooner than 16 weeks following the previous infusion.
Hyppigheden af grad 3/4 bivirkninger i blod og lymfesystemet var højere hos ældre patienter med tidligere ubehandlet eller relaps/refraktær CLL, sammenlignet med hos yngre patienter (< 65 år).
The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients (< 65 years), with previously untreated or relapsed/refractory CLL.
4 se også afsnittet om infusionsrelaterede reaktioner herunder.
4 see also section infusion-related reactions below.
Det sæt af reaktioner, der omfatter cytokinfrigivelsessyndrom, tumorlysesyndrom samt anafylaktiske reaktioner og overfølsomhedsreaktioner beskrives nedenfor.
This set of reactions which includes syndrome of cytokine release, tumour lysis syndrome and anaphylactic and hypersensitivity reactions are described below.
Prækliniske toksicitetsstudier i forbindelse med reproduktion udført i cynomolgusaben i doser på op til 100 mg/kg (behandling på dagene 20-50 i graviditeten) og har ikke vist tegn på føtal toksicitet af rituximab.
Developmental toxicity studies have been performed in cynomolgus monkeys at doses up to 100 mg/kg (treatment on gestation days 20-50) and have revealed no evidence of toxicity to the foetus due to rituximab.
I det kliniske forsøg med induktion af remission udviklede 24 % af patienterne i rituximab-gruppen (ét forløb) og 23 % af patienterne i cyclophosphamid-gruppen neutropeni af CTC-grad 3 eller derover.
In the induction of remission clinical trial, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
I CLL 1. linjestudiet oplevede Binet C patienter i R-FC-armen flere bivirkninger sammenlignet med patienter i FC-armen (R-FC 83 % versus FC 71 %).
In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC 71%).
• du har svært nedsat hjertefunktion eller svær, ukontrolleret hjertesygdom og har granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris.
• you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
Efterfølgende Ritemvia-doser kan infunderes med 100 mg/time initialt og øges med 100 mg/time hvert 30. minut til højst 400 mg/time.
Subsequent doses of Ritemvia can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Hyppigheden var baseret på alle bivirkninger, uanset sværhedsgrad (fra lette til alvorlige bivirkninger), bortset fra bivirkninger, som er markeret med “+”, hvor hyppigheden kun er baseret på alvorlige bivirkninger (NCI common toxicity criteria ≥ grad 3).
For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+" where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
I de kliniske studier med rituximab-monoterapi givet i 4 uger forekom hæmatologiske bivirkninger hos en minoritet af patienterne; bivirkningerne var sædvanligvis lette og reversible.
In clinical trials with rituximab monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
Tabel 8 Induktionsfase: Oversigt over effektdata for CHOP versus R-CHOP (31 måneders median observationstid) CHOP
Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP
Hvor meget medicin skal du have og hvor ofte?
How much and how often you will receive your treatment a)
Den samlede responsrate i intent-to-treat populationen var 48 % (95 % konfidensinterval: 41 %56 %) med 6 % komplet respons (CR) og 42 % partielt respons (PR).
The overall response rate (ORR) in the intent-to-treat (ITT) population was 48% (CI95% 41% - 56%) with a 6% complete response (CR) and a 42% partial response (PR) rate.
Du kan have behov for ekstra overvågning under din behandling med Ritemvia.
Your doctor may need to take special care of you during your treatment with Ritemvia.
Hos patienter med reumatoid artrit sås øjeblikkelig B-celle depletering i perifert blod efter to infusioner af 1.000 mg rituximab med 14 dages interval.
In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg rituximab separated by a 14 day interval.
Der er rapporteret om tilfælde af reaktivering af hepatitis B, hvoraf de fleste forekom hos patienter, som fik rituximab i kombination med cytotoksisk kemoterapi.
Cases of hepatitis B reactivation, have been reported, the majority of which were in patients receiving rituximab in combination with cytotoxic chemotherapy.
Alvorlig hjerteinsufficiens (New York Heart Association klasse IV) eller alvorlig, ukontrolleret hjertesygdom (se pkt.
Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease (see section 4.4 regarding other cardiovascular diseases).
Kontraindikationer for anvendelse til non-Hodgkin-lymfom og kronisk lymfatisk leukæmi Overfølsomhed over for det aktive stof, murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
Contraindications for use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Der var tilsyneladende ingen negativ påvirkning af tilstedeværelsen af ADA på sikkerheden eller effekten i studiet med induktion til remission.
There was no apparent negative impact of the presence of ADA on safety or efficacy in the induction of remission trial.
Hos patienter der er blevet behandlet med rituximab, er der observeret udvikling af symptomer på tidligere eksisterende iskæmiske hjertelidelser, såsom angina pectoris, ligesom atriel flimren og flagren.
In patients treated with rituximab, the occurrence of pre-existing ischemic cardiac conditions becoming symptomatic, such as angina pectoris, has been observed, as well as atrial fibrillation and flutter.
Øre og labyrint tinnitus, øresmerter høretab5
Ear and labyrinth disorders tinnitus, ear pain hearing loss5
Fordelen ved rituximab vedligeholdelsesbehandling blev bekræftet af alle undergruppeanalyser, uafhængigt af induktionsbehandlingen (CHOP eller R-CHOP) eller graden af respons på induktionsbehandlingen (CR eller PR) (tabel 9).
The benefit of rituximab maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (Table 9).
Det bør overvejes at give disse patienter første infusion med nedsat infusionshastighed eller at fordele dosis over to dage i første serie og hver af de efterfølgende serier, hvis lymfocyttallet stadig er > 25 x 109/l.
Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle and any subsequent cycles if the lymphocyte count is still >25 x 109/L.
respirationssvigt4
respiratory failure4
Under infusionen blev der rapporteret om arytmier af grad 3 eller 4 (herunder ventrikulær og supraventrikulær takykardi) og angina pectoris.
Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported.
Derfor bør patienter med hjertelidelse i anamnesen monitoreres nøje (se afsnittet Infusionsrelaterede reaktioner ovenfor).
Therefore patients with a history of cardiac disease should be monitored closely (see Infusion related reactions, above).
Meget sjældent kan der forekomme alvorlige, eventuelt livstruende hudsygdomme med blærer.
Very rarely, severe blistering skin conditions that can be life-threatening may occur.
lungeinfiltrater
lung infiltration
Patientkortet indeholder vigtige oplysninger om sikkerhed for patienterne angående potentiel øget risiko for infektioner, herunder progressiv multifokal leukoencefalopati (PML).
The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Gennemsnitlig clearance og fordelingsvolumen for rituximab var henholdsvis 0,313 l/dag (0,116-0,726 l/dag) og 4,50 l (2,25-7,39 l).
Rituximab mean clearance and volume of distribution were 0.313 L/day (range, 0.116 to 0.726 L/day) and 4.50 L (range 2.25 to 7.39 L) respectively.
Under anvendelse af aseptiske procedurer trækkes den nødvendige mængde Ritemvia op og fortyndes til en beregnet koncentration på 1 til 4 mg/ml rituximab i en infusionspose, der indeholder steril, pyrogenfri natriumchloridopløsning til injektion 9 mg/ml (0,9 %) eller 5 % D-glukose i vand.
Aseptically withdraw the necessary amount of Ritemvia, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Patienter kunne få 1.000 mg intravenøst på tidspunktet for recidiv (se pkt.
Patients could receive 1000 mg IV at the time of relapse (see section 5.1).
• blodprop, nedsat produktion og hurtigere ødelæggelse af røde blodlegemer (aplastisk hæmolytisk anæmi), hævede eller forstørrede lymfekirtler
• blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes
Præmedicinering med intravenøs glukokortikoid reducerede forekomsten og sværhedsgraden af IRR signifikant (se pkt.
Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of IRRs (see sections 4.2 and 4.4).
I relaps/refraktær-studiet var medianen for progressionsfri overlevelse (det primære endepunkt) 30,6 måneder i R-FC-gruppen og 20,6 måneder i FC-gruppen (p = 0,0002, log-rank test).
In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
Pemfigus vulgaris er en autoimmun sygdom, der forårsager smertefulde blærer på huden og mundens, næsens, halsens og kønsorganernes slimhinder.
Pemphigus vulgaris is an autoimmune condition that causes painful blisters on the skin and lining of the mouth, nose, throat and genitals.
Hvis du behandles for non-Hodgkin-lymfom
If you are being treated for non-Hodgkin's Lymphoma
Rituximab bør ikke administreres til patienter med en aktiv, alvorlig infektion (for eksempel tuberkulose, sepsis og opportunistiske infektioner, se pkt.
Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Ritemvia vedligeholdelsesbehandling er indiceret til behandling af follikulært lymfom hos patienter, der responderer på induktionsbehandling.
Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
I alt 19 ud af 34 (56 %) patienter med PV, som blev behandlet med rituximab, testede positive for ADA antistoffer ved måned 18.
A total of 19/34 (56%) patients with PV, who were treated with rituximab, tested positive for ADA antibodies by 18 months.
• lavt antal blodplader
• low numbers of platelets in the blood
Samlet set oplevede 4% af patienterne i rituximab-armen bivirkninger der ledte til seponering.
Overall, 4% of patients in the rituximab arm experienced adverse events leading to discontinuation.
Alvorlige infektioner, herunder dødelige, kan forekomme under behandlingen med rituximab (se pkt.
Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).
• Information om symptomer på infektioner, især PML, og nødvendigheden af at kontakte deres læge straks, hvis de får nogle symptomer
• Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any
• sammensnøring af musklerne i luftvejene, som forårsager hvæsende vejrtrækning
• tightening of the muscles in the airways which causes wheezing (bronchospasm),
• Aktivt stof i Ritemvia: Rituximab.
• The active ingredient in Ritemvia is called rituximab.
Symptomerne på infusionsrelaterede reaktioner var lignende i type og sværhedsgrad med dem set hos patienter med reumatoid artrit og GPA/MPA.
Symptoms of infusion-related reactions were similar in type and severity to those seen in RA and GPA/MPA patients.
Sikkerhed og effekt af Ritemvia er ikke påvist i kombination med andre kemoterapiregimer til behandling af diffust storcellet B-celle non-Hodgkin-lymfom.
Safety and efficacy of Ritemvia have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Non-Hodgkin-lymfom er en sygdom i lymfesystemet (en del af immunsystemet), der påvirker de hvide blodlegemer, der kaldes B-lymfocytter.
This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes.
Ældre Dosisjustering er ikke nødvendig hos ældre patienter (alder > 65 år).
Elderly No dose adjustment is required in elderly patients (aged > 65 years).
I endnu et klinisk studie blev i alt 57 patienter med svær, aktiv GPA og MPA i sygdomsremission behandlet med rituximab for vedligeholdelse af remission (se pkt.
In a further clinical study, a total of 57 severe, active GPA and MPA patients in disease remission were treated with rituximab for the maintenance of remission (see section 5.1).
I en subgruppeanalyse var den samlede responsrate højere hos patienter med histologisk subtype IWF B, C og D sammenlignet med subtype IWF A (58 % versus 12 %), højere hos patienter hvis største læsions længste diameter var < 5 cm versus > 7 cm (53 % versus 38 %) og højere hos patienter med kemoterapifølsomt relaps sammenlignet med kemoterapi-resistent relaps (defineret som en responsvarighed < 3 måneder) (50 % versus 22 %).
In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58% vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response < 3 months) relapse (50% vs. 22%).
Antallet af patienter behandlet med rituximab plus lavdosis prednison uden prednison-behandling eller behandlet minimalt (prednison dosis på 10 mg eller mindre pr. dag) viser en steroidbesparende virkning ad rituximab sammenlignet med patienter behandlet med standarddosis prednison over behandlingsperioden på 24 måneder (figur 4).
The number of rituximab plus low-dose prednisone patients off prednisone therapy or on minimal therapy (prednisone dose of 10 mg or less per day) compared to standard-dose prednisone patients over the 24-month treatment period shows a steroid-sparing effect of rituximab (Figure 4).
Progressionsfri overlevelse (PFS) Samlet overlevelse
Progression-free survival (PFS) Overall survival
Den hyppigst indberettede alvorlige infektion i rituximab-gruppen var pneumoni med en forekomst på 4 %.
The most frequently reported serious infection in the rituximab group was pneumonia at a frequency of 4%.
Ritemvia skal administreres som to 500 mg intravenøse infusioner, med to ugers mellemrum, efterfulgt af en 500 mg intravenøs infusion hver 6. måned.
Ritemvia should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Der var tilsyneladende ingen negativ indvirkning ved tilstedeværelsen af ADA på sikkerheden eller effekten i det kliniske studie med vedligeholdelsesbehandling.
There was no apparent negative impact of the presence of ADA on safety or efficacy in the maintenance therapy clinical trial.
Hvis behandlingen virker, kan Ritemvia fortsættes i 2 år efter, den første behandling er givet.
In patients where the treatment is working, Ritemvia may be continued for 2 years after completing the initial treatment.
Derfor bør patienter med hjertelidelse og/eller tidligere kardiotoksisk kemoterapi i anamnesen monitoreres nøje.
Therefore, patients with a history of cardiac disease and/or cardiotoxic chemotherapy should be monitored closely.
Den mediane responsvarighed var 37,7 måneder i R-CVP-gruppen, og den var 13,5 måneder i CVP-gruppen (p < 0,0001), log rank test).
The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p < 0.0001, log-rank test).
Fortæl lægen, apotekspersonalet eller sundhedspersonalet om al medicin du tager i øjeblikket, har taget for nyligt eller planlægger at tage.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Den tilberedte rituximab infusionsopløsning er i 5 % D-glukose opløsning fysisk og kemisk stabil i 24 timer ved 2 °C - 8 °C og efterfølgende 12 timer ved stuetemperatur (ikke over 30 °C).
The prepared infusion solution of rituximab in 5% glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
• nældefeber, øget svedtendens, nattesved
• hives, increased sweating, night sweats
Den færdige infusionsopløsning må ikke administreres som hurtig intravenøs injektion eller bolus.
It should not be administered as an intravenous push or bolus.
† resultat ved uge 24 Signifikant forskel fra placebo + MTX ved det primære tidspunkt: ***p ≤ 0,0001
Significant difference from placebo + MTX at the primary time point: ***p ≤ 0.0001
Ingen alvorlige infusionsrelaterede reaktioner blev observeret.
No serious IRRs were observed.
Specielle populationer - rituximab monoterapi
Patient subpopulations - rituximab monotherapy
Rituximab i kombination med methotrexat øgede signifikant andelen af patienter, der opnåede mindst 20 % forbedring i ACR-score, sammenlignet med patienter behandlet med methotrexat alene (tabel 12).
Rituximab in combination with methotrexate significantly increased the proportion of patients achieving at least a 20% improvement in ACR score compared with patients treated with methotrexate alone (Table 12).
Hos patienter med non-Hodgkin-lymfom bør det overvejes at give præmedicinering med glukokortikoider, hvis Ritemvia ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
In patients with non-Hodgkin's lymphoma, premedication with glucocorticoids should be considered if Ritemvia is not given in combination with glucocorticoid-containing chemotherapy.
Effekt og sikkerhed af rituximab til lindring af symptomer og kliniske fund ved reumatoid artrit hos patienter med et utilstrækkelig respons på TNF-hæmmere blev vist i et pivotalt, randomiseret, kontrolleret, dobbeltblindet, multicenterstudie (studie 1).
The efficacy and safety of rituximab in alleviating the symptoms and signs of rheumatoid arthritis in patients with an inadequate response to TNF-inhibitors was demonstrated in a pivotal randomised, controlled, double-blind, multicentre trial (Trial 1).
Risiko reduktion
Risk reduction
Dette svarer til 13,2% af den anbefalede maximale daglige indtagelse af natrium for en voksen.
This is equivalent to 13.2% of the recommended maximum daily dietary intake of sodium for an adult.
Der er begrænset erfaring fra kliniske studier hos mennesker med doser over den godkendte dosis af intravenøse rituximab-formuleringer.
Limited experience with doses higher than the approved dose of intravenous rituximab formulation is available from clinical trials in humans.
4,06 år
4.06 years
Blandt de 3.189 patienter, som blev behandlet med rituximab, fik 1.135 (36 %) mindst en IRR, og 733/3.189 (23 %) af patienterne fik en IRR efter første infusion i den første rituximab-behandling.
Among the 3189 patients treated with rituximab, 1,135 (36%) experienced at least one IRR with 733/3,189 (23%) of patients experiencing an IRR following first infusion of the first exposure to rituximab.
Hvis vaccination med ikke levende vacciner er nødvendig samtidig med behandling med rituximab, bør vaccinationerne være gennemført mindst 4 uger inden næste behandling med rituximab.
Should non-live vaccinations be required whilst receiving rituximab therapy, these should be completed at least 4 weeks prior to commencing the next course of rituximab.
Hvis en sådan bivirkning skulle opstå med formodet relation til rituximab, skal behandlingen seponeres permanent.
In case of such an event with a suspected relationship to rituximab, treatment should be permanently discontinued.
I generelle toksicitetsstudier med cynomolgusaber sås ingen negativ effekt på reproduktionsorganer hos hanner og hunner.
In general toxicity studies in cynomolgus monkeys no deleterious effects on reproductive organs in males or females were observed.
Dosisjustering er ikke nødvendig hos ældre patienter (alder > 65 år).
Elderly No dose adjustment is required in elderly patients (aged >65 years).
Den hyppigste bivirkning efter administration af rituximab i kliniske studier var infusionsrelaterede reaktioner (IRR) (se tabel 2).
The most frequent ADRs following receipt of rituximab in clinical studies were IRRs (refer to Table 2).
KI: konfidensinterval; TNLT: Tid til næste anti-lymfom-behandling; TNCT: Tid til næste kemoterapibehandling; NR: Ikke opnået ved det kliniske skæringstidspunkt.
confidence interval; FU: follow-up; TNLT: time to next anti-lymphoma treatment; TNCT: time to next chemotherapy treatment; NR: not reached at time of clinical cut-off.
Den tilberedte rituximab infusionsopløsning er i 0.9 % natriumchlorid opløsning fysisk og kemisk stabil i 30 dage ved 2 °C - 8 °C og efterfølgende 24 timer ved stuetemperatur (ikke over 30 °C).
The prepared infusion solution of rituximab in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2 °C - 8 °C and subsequently 24 hours at room temperature (not more than 30 °C).