FrancophonIA/ELRC3.0 huggingface dataset:
English: Infusion related adverse reactions of all kinds have been observed in 77% of patients treated with rituximab (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10 % of patients) see section 4.8.
Danish: Infusionsrelaterede bivirkninger af enhver art er set hos 77 % af patienterne behandlet med rituximab (herunder cytokinfrigivelsessyndrom ledsaget af hypotension og bronkospasme er set hos 10 % af patienterne) se pkt.
English: No incompatibilities between rituximab and polyvinyl chloride or polyethylene bags or infusion sets
Danish: Der er ikke observeret uforligeligheder mellem rituximab og polyvinylchlorid eller polyethylen infusionsposer eller infusionssæt.
English: The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p = 0.0001).
Danish: Den endelige analyse bekræftede, at R-CHOP behandlingen var forbundet med klinisk relevant og statistisk signifikant forbedring af længden af den progressionsfrie overlevelse (de primære effektparametre var død, relaps, forværring af lymfomet eller påbegyndelse af ny antilymfombehandling) (p = 0,0001).
English: Rituzena should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Danish: Rituzena bør gives på dag 1 i hver kemoterapiserie, efter intravenøs indgift af glukokortikoidkomponenten, hvis det anvendes.
English: Rituximab is associated with infusion related reactions (IRRs), which may be related to release of cytokines and/or other chemical mediators.
Danish: Rituximab er forbundet med infusionsrelaterede reaktioner (IRR), som kan være relaterede til frigivelse af cytokiner og/eller andre kemiske mediatorer.
English: No dose reductions of Rituzena are recommended.
Danish: Der er ingen anbefalinger vedrørende dosisreduktion af Rituzena.
English: Rarely Rituzena can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Danish: Rituzena har i sjældne tilfælde forårsaget en alvorlig hjerneinfektion, som kaldes ”Progressiv multifokal leukoencefalopati” (PML).
English: The Patient information about Rituzena should contain the following key elements:
Danish: Information til patienten om Rituzena skal indeholde følgende nøgle-elementer:
English: The benefit in terms of PFS was observed in almost all patient subgroups analysed according to disease risk at baseline.
Danish: Fordelen med hensyn til PFS blev konsistent observeret i de fleste patientgrupper, som blev analyseret i forhold til sygdomsrisikoen ved baseline
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Rituzena (the last dose of methylprednisolone may be given on the same day as the first infusion of Rituzena).
Danish: Hos patienter med granulomatose med polyangiitis (Wegeners granulomatose) eller mikroskopisk polyangiitis anbefales det at give methylprednisolon intravenøst i 1-3 dage i en dosis på 1.000 mg pr. dag inden den første Rituzena-infusion (sidste dosis methylprednisolon kan gives samme dag som første Rituzena-infusion).
English: • Detailed information on the risk of PML, the need for timely diagnosis of PML
Danish: • Detaljeret information om risikoen for PML, nødvendigheden af at diagnosticere PML i tide og egnede metoder til at diagnosticere PML
English: Treatment with Rituzena uses four separate infusions given at weekly intervals.
Danish: Hvert behandlingsforløb med Rituzena består af fire separate infusioner, der gives med én uges mellemrum.
English: Neutropenia was not associated with an observed increase in serious infection in rituximab-treated patients.
Danish: Neutropeni var ikke forbundet med en øget frekvens af alvorlige infektioner blandt rituximab-behandlede patienter.
English: Name and address of the manufacturer of the biological active substance CELLTRION Inc.,
Danish: Navne og adresse på fremstilleren af det biologisk aktive stof
English: 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.
Danish: Antistoffet fremstilles ved mammalian (kinesisk hamster ovarie) cellesuspensionskultur og renses ved affinitetskromatografi og ionbytning, inklusive specifik viral
English: No long-term animal studies have been performed to establish the carcinogenic potential of rituximab.
Danish: Der er ikke gennemført langtidsstudier på dyr med henblik på vurdering af rituximabs karcinogene
English: Severe (grade 3/4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Danish: Svær (grad 3 og 4) neutropeni forekom hos 4,2 % af patienterne, svær anæmi hos 1,1 %, og svær trombocytopeni hos 1,7 %.
English: Look out for the following possible signs of infection:
Danish: Hold øje med følgende mulige symptomer på en
English: • If you are having Rituzena with chemotherapy Rituzena will be given to you on the same day as your chemotherapy.
Danish: • Hvis du får Rituzena sammen med kemoterapi Rituzena gives samme dag som kemoterapien.
English: This can be fatal.
Danish: Heraf var nogle fatale.
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Rituzena to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Danish: Til patienter med lymfocyttal > 25 x 109/l bør der gives 100 mg prednison eller prednisolon intravenøst kort tid før infusionen med Rituzena for at nedsætte antallet og sværhedsgraden af akutte infusionsreaktioner og/eller cytokinfrigivelsessyndrom.
English: This is because Rituzena can affect the way some other medicines work.
Danish: Det er vigtigt, da Rituzena kan påvirke virkningen af anden medicin, og anden medicin kan påvirke
English: All patients treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis must be given the patient alert card with each infusion.
Danish: Alle patienter behandlet med rituximab for reumatoid artrit, granulomatose med polyangiitis eller mikroskopisk polyangiitis skal have udleveret patientkortet ved hver infusion.
English: Medicines given before each Rituzena administration
Danish: Medicin, der gives inden hver behandling med Rituzena
English: Cases of hepatitis B reactivation,have been reported, the majority of which were in patients receiving rituximab in combination with cytotoxic chemotherapy.
Danish: Der er rapporteret om tilfælde af reaktivering af hepatitis B, hvoraf de fleste forekom hos patienter, som fik rituximab i kombination med cytotoksisk kemoterapi.
English: In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (<7 g/L) after induction treatment in both the observation and the rituximab groups.
Danish: I kliniske studier med rituximab som vedligeholdelsesbehandling af recidiveret/ refraktært follikulært lymfom var de mediane IgG-niveauer under nedre referencegrænse (< 7 g/l) i både observationsgruppen og rituximab-gruppen efter induktionsbehandlingen.
English: In the 99 rituximab patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197-285) at the 6-month primary endpoint.
Danish: Hos de 99 rituximab-patienter var den samlede infektionshyppighed ca. 237 pr. 100 patientår (95 % konfidensinterval 197-285) ved det primære endepunkt ved måned 6.
English: 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
Danish: 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
English: Gastrointestinal
Danish: Gastrointestinale sygdomme
English: The pharmacokinetic profile of rituximab when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with rituximab alone.
Danish: Den farmakokinetiske profil af rituximab, når det blev givet som 6 infusioner af 375 mg/m2 i kombination med 6 serier af CHOP kemoterapi, var sammenlignelig med den for rituximab indgivet
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Rituzena or patients refractory to previous Rituzena plus chemotherapy.
Danish: Der er kun begrænsede effekt-og sikkerhedsdata tilgængelige for patienter, som tidligere er behandlet med monoklonale antistoffer inklusive Rituzena, og for patienter, som er refraktære over for tidligere behandling med Rituzena og kemoterapi.
English: The transient IgM increase usually returned to at least
Danish: Den forbigående stigning i IgM vender normalt tilbage til baseline inden 4 måneder.
English: Aseptically withdraw the necessary amount of Rituzena, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride9 mg/mL (0.9%) solution for injection or 5 % D-Glucose in water.
Danish: Under anvendelse af aseptiske procedurer trækkes den nødvendige mængde Rituzena 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.
English: What you need to know before you use Rituzena
Danish: Det skal du vide, før du begynder at få Rituzena
English: Safety and efficacy of Rituzena have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Danish: Sikkerhed og effekt af Rituzena er ikke påvist i kombination med andre kemoterapiregimer til behandling af diffust storcellet B-celle non-Hodgkin-lymfom.
English: 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.
Danish: Den samlede responsrate i intent-to-treat populationen var 48 % (95 % konfidensinterval: 41 %56 %) med 6 % komplet respons (CR) og 42 % partielt respons (PR).
English: If you have granulomatosis with polyangiitis or microscopic polyangiitis also tell your doctor
Danish: Hvis du har granulomatose med polyangiitis eller mikroskopisk polyangiitis fortæl da også din
English: anaphylaxis tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-relate d acute reversible thrombocytop enia4
Danish: anafylaksi tumorlysesyndrom, cytokinfrigivelsessyndrom4, serumsygdom infusionsrelateret akut, reversibel trombocytopen i4
English: In patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if Rituzena is not given in combination with glucocorticoid-containing chemotherapy.
Danish: Hos patienter med non-Hodgkin-lymfom og kronisk lymfatisk leukæmi bør det overvejes at give præmedicinering med glukokortikoider, hvis Rituzena ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
English: The chemotherapy should be given after the Rituzena infusion.
Danish: Kemoterapien skal gives efter infusionen med Rituzena.
English: Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in
Danish: Overfølsomhed over for det aktive stof, murine proteiner eller over for et eller flere af hjælpestofferne
English: • The active ingredient in Rituzena is called rituximab.
Danish: • Aktivt stof i Rituzena: Rituximab.
English: The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis.
Danish: Rituximabs Fab domæne bindes til CD20 antigenet på B-lymfocytter og Fc domænet kan rekruttere immuneffektor funktioner til at mediere B-celle lysis.
English: 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.
Danish: 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
English: The Physician information about Rituzena should contain the following key elements:
Danish: Informationen til lægen om Rituzena skal indeholde følgende nøgle-elementer:
English: Cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Danish: Kardielle bivirkninger blev rapporteret med en hyppighed på ca. 273 pr. 100 patientår (95 % konfidensinterval 149-470) ved det primære endepunkt ved måned 6.
English: Table 4 Summary of key results from four phase III randomised studies evaluating the benefit of rituximab with different chemotherapy regimens in follicular lymphoma
Danish: Tabel 4 Opsummering af nøgleresultater fra fire fase-III-randomiserede studier, der evaluerer fordelene ved rituximab med forskellige kemoterapibehandlinger ved
English: The prepared Rituzena solution should be administered as an intravenous infusion through a dedicated line.
Danish: Den tilberedte Rituzena-opløsning skal gives som en intravenøs infusion gennem en separat anlagt intravenøs adgang.
English: • Warning on the risk of infections and PML, including the symptoms • The need for patients to contact their health care professional if symptoms occur
Danish: • Advarsel om risikoen for infektioner og PML, inklusive alle symptomer • Nødvendigheden af, at patienterne kontakter deres læge, hvis de får symptomer
English: Granulomatosis with polyangiitis and microscopic polyangiitis Rituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Danish: Granulomatose med polyangiitis og mikroskopisk polyangiitis Rituzena er i kombination med glukokortikoider indiceret til induktion af remission hos voksne patienter med svær, aktiv granulomatose med polyangiitis (Wegeners granulomatose) (GPA) eller mikroskopisk polyangiitis (MPA).
English: Summary of the safety profile (non-Hodgkin's lymphoma and chronic lymphocytic leukaemia)
Danish: Resumé af sikkerhedsprofilen (non-Hodgkin-lymfom og kronisk lymfatisk leukæmi)
English: It is designed to stick to a type of white blood cell called “B-Lymphocyte”.
Danish: Det er beregnet til at binde sig til de hvide blodlegemer, der kaldes Blymfocytter.
English: Rituzena is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Danish: Rituzena er en klar, farveløs opløsning, leveret som koncentrat til infusionsvæske, opløsning i et hætteglas.
English: The incidence of malignancy in rituximab treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period).
Danish: Malignitetshyppigheden blandt rituximab-behandlede patienter i det kliniske studie med patienter med granulomatose med polyangiitis eller mikroskopisk polyangiitis var 2,00 pr. 100 patientår ved studiets slutning (da sidste patient havde gennemført opfølgningsperioden).
English: 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.
Danish: Hvis vaccination med ikke levende vacciner er nødvendig samtidig med behandling med rituximab, bør vaccinationerne være gennemført mindst 4 uger inden næste
English: 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.
Danish: Rituximabs sikkerhedsprofil ved non-Hodgkin-lymfom og kronisk lymfatisk leukæmi er baseret på data fra patienter fra kliniske studier og fra post-marketing overvågning.
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1 % for patients in the CVP group．
Danish: Forskellen i den samlede overlevelse viste en stærk klinisk forskel (p = 0,029, log rank test stratificeret ved center): overlevelsesrater på 53 måneder var 80,9 % for patienter i R-CVP-gruppen i forhold til
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Rituzena.
Danish: Der bør altid gives præmedicin bestående af et anti-pyretisk lægemiddel samt et antihistamin, f.eks. paracetamol og diphenhydramin, inden hver Rituzena-administration.
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2mg/kg/day) for 3-6 months or rituximab (375 mg/m2) once weekly for 4 weeks.
Danish: Patienterne blev randomiseret i forholdet 1:1 til daglig behandling med cyclophosphamid oralt (2 mg/kg/dag) i 3-6 måneder eller rituximab (375 mg/m2) én gang ugentligt i 4 uger.
English: Prednisone tapering was to be completed by 6 months from the start of study treatment.
Danish: Nedtitrering af prednison skulle være gennemført 6 måneder efter start af
English: lung infiltration gastro-intestin al perforation7
Danish: lungeinfiltrater forstørret abdomen gastrointestinal perforation7
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Rituzena.
Danish: Hvis du er i tvivl, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden du får Rituzena.
English: • an increase in the amount of potassium in the blood • changes in the rhythm of the heart, or the heart beating faster than normal
Danish: • ændringer i hjerterytmen, eller hjertet slår hurtigere end normalt
English: In rheumatoid arthritis premedication with glucocorticoids should also be administered before each infusion of rituximab in order to reduce the frequency and severity of IRRs
Danish: Hos patienter med reumatoid artrit bør præmedicinering med glukokortikoider også gives før hver rituximab-infusion for at reducere hyppigheden og sværhedsgraden af infusionsrelaterede reaktioner
English: Patients in both arms received 1000mg of pulse intravenous (IV) methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Danish: I begge arme fik patienterne intravenøs pulsbehandling med 1.000 mg methylprednisolon (eller andet glukokortikoid i ækvivalent dosis) pr. dag i 1-3 dage efterfulgt af oral prednison (1 mg/kg/dag, dog højst 80 mg/dag).
English: In the overall experience of rituximab repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Danish: Ved gentagen behandling af patienter med reumatoid artrit med rituximab gennem et år er den samlede erfaring, at andelen af patienter med positive antistoftitere over for S. pneumoniae, influenza, mæslinger, røde hunde, skoldkopper og tetanustoksoid generelt var sammenlignelige til andelen ved
English: severe bullous skin reactions, Stevens-Johns on Syndrome toxic epidermal necrolysis (Lyell's Syndrome)7,
Danish: svære bulløse hudreaktioner, StevensJohnsons syndrom, toksisk epidermal nekrolyse (Lyells syndrom)7
English: • heart problems - such as heart attack and uneven or fast heart rate
Danish: • hjerteproblemer, f.eks. hjerteanfald og uregelmæssig eller hurtig hjerteaktion (puls)
English: Premedication consisting of an analgesic/anti-pyretic medicinal product and an anti-histaminic medicinal product, should always be administered before each infusion of rituximab.
Danish: Præmedicinering bestående af et analgetikum/antipyretikum og et antihistamin bør altid gives før hver rituximab-infusion.
English: Rituzena monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
Danish: Rituzena monoterapi er indiceret til behandling af patienter med grad III-IV follikulært lymfom, som er resistente overfor kemoterapi eller som er i deres andet eller efterfølgende relaps efter kemoterapi.
English: In the active-controlled, randomised, double-blind, multicentre, non-inferiority trial of rituximab in granulomatosis with polyangiitis and microscopic polyangiitis, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Danish: I det randomiserede, dobbeltblindede, non-inferioritets-multicenterstudie med aktiv kontrolgruppe med rituximab til behandling af patienter med granulomatose med polyangiitis eller mikroskopisk polyangiitis udviklede 24 % af patienterne i rituximab-gruppen (ét forløb) og 23 % af patienterne i cyclophosphamid-gruppen neutropeni af CTC-grad 3 eller derover.
English: At 6 months, in the active-controlled, randomised, double-blind, multicentre, non-inferiority trial, in the rituximab group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline, had low IgA, IgG and IgM levels, respectively compared to 25%, 50% and 46% in the cyclophosphamide group.
Danish: I rituximab-gruppen i det randomiserede, dobbeltblindede, non-inferioritetsmulticenterstudie med en aktiv kontrolgruppe havde henholdsvis 27 %, 58 % og 51 % af patienterne med normale immunglobulin-niveauer ved baseline lave IgA-, IgG- og IgM-niveauer ved måned 6 sammenlignet med henholdsvis 25 %, 50 % og 46 % i cyclophosphamid-gruppen.
English: The limited data from the present trial preclude any conclusions regarding the efficacy of subsequent courses of rituximab in patients with granulomatosis with polyangiitis and microscopic polyangiitis.
Danish: De begrænsede data fra det foreliggende studie umuliggør en konklusion med hensyn til effekten af efterfølgende forløb med rituximab hos patienter med granulomatose med polyangiitis eller
English: • raised blood pressure
Danish: • forhøjet kalium i blodet
English: This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphataemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
Danish: Dette syndrom kan ligne kliniske fund på tumorlysesyndrom som hyperuricæmi, hyperkaliæmi, hypocalcæmi, hyperphosphatæmi, akut nyresvigt, forhøjet laktatdehydrogenase (LD) og kan medføre akut respirationssvigt og død.
English: Package leaflet: Information for the patient Rituzena 500 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Rituzena 500 mg koncentrat til infusionsvæske, opløsning rituximab Dette lægemiddel er underlagt supplerende overvågning.