FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should receive Truxima for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Danish: Patienter skal gives Truxima i mindst 24 måneder efter opnåelse af remission (fravær af kliniske symptomer).
English: Truxima in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Danish: Truxima anvendt sammen med kemoterapi ødelægger disse celler, som gradvis fjernes fra kroppen ved biologiske processer.
English: The safety and efficacy of Truxima in children below 18 years has not been established.
Danish: Pædiatrisk population Truximas sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more Truxima.
Danish: Afhængigt af kliniske fund og symptomer på din sygdom, vil din læge bedømme, om du skal have mere Truxima.
English: • high cholesterol levels in the blood
Danish: • høje kolesterolniveauer i blodet
English: Your doctor will check if you should have any vaccines before you receive Truxima.
Danish: Din læge vil undersøge, om du bør vaccineres inden du får Truxima.
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Truxima.
Danish: • Vis dette kort til enhver læge, sygeplejerske eller tandlæge, som er involveret i din behandling - og ikke kun til den læge, der udskriver Truxima til dig
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6)
Danish: • du er allergisk over for rituximab, andre proteiner, der ligner rituximab eller et af de øvrige indholdsstoffer i Truxima (angivet i punkt 6).
English: • If you are having Truxima alone Truxima will be given to you once a week for 4 weeks.
Danish: • Hvis du får Truxima alene Truxima gives en gang ugentligt i 4 uger.
English: Truxima is usually taken together with another medicine called methotrexate.
Danish: Truxima bruges som regel sammen med et andet lægemiddel, kaldet methotrexat.
English: • The need to monitor patients for infections, especially PML, during and after Truxima treatment
Danish: • Nødvendigheden af at overvåge patienterne for infektioner, især PML, under og efter behandling med Truxima
English: See the Truxima package leaflet for more information.
Danish: Se indlægssedlen i Truxima-pakken for mere information.
English: Truxima slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
Danish: Truxima bremser beskadigelsen af dine led forårsaget af reumatoid artrit og forbedrer din evne til at udføre normale daglige aktiviteter.
English: * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
Danish: * Infusionsrelaterede reaktioner inkluderede symptomer indsamlet ved næste planlagte besøg efter hver infusion samt bivirkninger, der forekom på dagen eller dagen efter infusionen.
English: • hearing loss, loss of other senses b) If you are being treated for rheumatoid arthritis
Danish: • høretab og tab af andre sanser b) Hvis du behandles for reumatoid artrit
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of Truxima maintenance therapy, up to 5 years.
Danish: For patienter, som kan have højere risiko for recidiv, bør lægen overveje en længerevarende vedligeholdelsebehandling med Truxima, i op til 5 år.
English: The cells that are affected by Truxima help to fight infection and you should wait until the infection has passed before you are given Truxima.
Danish: Cellerne, der påvirkes af Truxima hjælper med at bekæmpe infektioner, og du bør vente med behandling med Truxima, indtil infektionen er forsvundet.
English: • If you respond well to treatment, you may be given Truxima every 2 or 3 months for two years.
Danish: • Hvis medicinen virker godt hos dig, kan du få Truxima hver 2. eller 3. måned i op til 2 år.
English: Truxima will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Danish: Du får Truxima af en læge eller sygeplejerske med erfaring i denne behandling.
English: Truxima contains sodium
Danish: Truxima indeholder natrium
English: Your doctor may prescribe Truxima for the treatment of:
Danish: Din læge kan ordinere Truxima til behandling for:
English: • The need to check, prior to Truxima treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Danish: • Nødvendigheden af at kontrollere for infektioner, for immunsuppression, for tidligere/nuværende medicinering, der påvirker immunsystemet, og for nylige og/eller planlagte vaccinationer før behandling med Truxima påbegyndes
English: When Truxima is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Danish: Når Truxima gives i kombination med kemoterapi, bør standard dosisreduktioner for de kemoterapeutiske lægemidler anvendes.
English: This is because some people have a fall in their blood pressure while they are being given Truxima.
Danish: Nogle har oplevet, at blodtrykket faldt, mens de fik Truxima
English: Keep this card with you for 2 years after your last dose of Truxima.
Danish: Opbevar dette kort på dig i 2 år efter, at du har fået den sidste Truxima-dosis.
English: • recurrence of a previous Hepatitis B infection d) If you are being treated for pemphigus vulgaris
Danish: • genopblussen af tidligere hepatitis B-infektion d) Hvis du behandles for pemfigus vulgaris
English: If you respond well to treatment, you may be given Truxima as a maintenance treatment.
Danish: Hvis du reagerer godt på behandlingen, kan du få Truxima som vedligeholdelsesbehandling.
English: Repeated treatment courses with Truxima are possible.
Danish: Gentagne behandlingsforløb med Truxima er mulige.
English: It is not known whether Truxima has an effect on you being able to drive or use any tools or machines.
Danish: Det vides ikke, om Truxima påvirker din evne til at køre motorkøretøj eller arbejde med maskiner.
English: • If you are having Truxima with chemotherapy Truxima will be given to you on the same day as your chemotherapy.
Danish: • Hvis du får Truxima sammen med kemoterapi Truxima gives samme dag som kemoterapien.
English: Other rarely-reported side-effects due to Truxima include a decreased number of white cells in the blood (neutrophils) that help to fight against infection.
Danish: Andre sjældent rapporterede bivirkninger af Truxima inkluderer nedsættelse i antallet af hvide blodlegemer (neutrofiler), som hjælper med at bekæmpe infektioner.
English: Truxima should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Danish: Truxima skal anvendes under tæt supervision af erfarent sundhedspersonale i omgivelser, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt (se pkt.
English: If you are having Truxima with other medicines, some of the side effects you may get may be due to the other medicines.
Danish: Hvis du får Truxima sammen med anden medicin, kan nogle bivirkninger være forårsaget af den anden medicin.
English: Truxima may also cause changes in laboratory tests carried out by your doctor.
Danish: Truxima kan også ændre resultaterne på de blodprøver, som lægen har bestilt.
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Truxima.
Danish: Hvis du er i den fødedygtige alder, skal du og din partner bruge sikker prævention, mens du er i behandling med Truxima.
English: • anxiety, depression
Danish: • angst, depression
English: Truxima contains the active substance “rituximab”.
Danish: Truxima indeholder det aktive indholdsstof rituximab.
English: • excess fluid retention in the face and body
Danish: • væskeophobning i ansigtet og kroppen
English: Truxima is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects.
Danish: Truxima anvendes til at behandle reumatoid artrit hos personer, der allerede har prøvet anden medicin, men hvor denne medicin enten er holdt op med at virke, ikke har virket godt nok eller har medført bivirkninger.
English: What you need to know before you use Truxima Do not take Truxima if:
Danish: Det skal du vide, før du begynder at få Truxima Du må ikke få Truxima, hvis:
English: Medicines given before each Truxima administration
Danish: Medicin, der gives inden hver behandling med Truxima
English: Truxima is used for the treatment of rheumatoid arthritis.
Danish: Truxima anvendes til behandling af reumatoid artrit.
English: Truxima should be used in combination with CHOP chemotherapy.
Danish: Truxima bør anvendes i kombination med CHOP kemoterapi.
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Truxima.
Danish: Der bør altid gives præmedicin bestående af et anti-pyretisk lægemiddel samt et antihistamin, f.eks. paracetamol og diphenhydramin, inden hver Truxima-administration.
English: • What you need to know before having
Danish: • Hvad du skal vide, før du får Truxima
English: You will always be given Truxima as a drip (intravenous infusion).
Danish: Truxima gives altid i et drop (intravenøs infusion).
English: The MAH must ensure that all physicians who are expected to prescribe Truxima are provided with the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som kan forventes at udskrive Truxima, har modtaget følgende:
English: • a complex of symptoms occurring within a few weeks of an infusion of Truxima including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
Danish: • et kompleks af symptomer, som forekommer inden for nogle få uger efter en infusion med Truxima, herunder allergiske reaktioner, såsom udslæt, kløe, ledsmerter, hævede lymfekirtler og feber
English: When you are treated with Truxima in combination with chemotherapy, you will receive Truxima infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
Danish: Hvis du behandles med Truxima i kombination med kemoterapi, vil du få en infusion med Truxima på dag 0 i serie 1 og derefter på dag 1 i hver af i alt 6 serier.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Danish: Profylakse mod Pneumocystis jiroveci-pneumoni (PCP) anbefales til patienter med GPA/MPA eller PV under og efter behandling med Truxima i det omfang, det er relevant i henhold til lokale kliniske retningslinjer.
English: Truxima is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Danish: Truxima er en klar, farveløs opløsning, leveret som koncentrat til infusionsvæske, opløsning i et hætteglas.
English: At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm.
Danish: Estimaterne ved 24 måneders overlevelse var 68,2 % i R-CHOP armen sammenlignet med 57,4 % i CHOP armen.
English: Truxima in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
Danish: Truxima er i kombination med methotrexat indiceret til behandling af svær, aktiv reumatoid artrit hos voksne patienter, som har haft et utilstrækkeligt respons på eller er intolerante over for andre sygdomsmodificerende antireumatiske lægemidler (DMARDs) inklusive en eller flere behandlinger med tumor-nekrose-faktor (TNF)-hæmmere.
English: Truxima should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Danish: Truxima bør gives på dag 1 i hver kemoterapiserie, efter intravenøs indgift af glukokortikoidkomponenten, hvis det anvendes.
English: Following induction of remission with other standard of care immunosuppressants, Truxima maintenance treatment should be initiated during the 4 week period that follows disease remission.
Danish: Efter induktion af remission med andre immunsuppresiva til standardbehandling skal Truxima vedligeholdelsesbehandling initieres i løbet af en 4 ugers periode efter opnåelse af sygdomsremission.
English: The Patient Alert Card for Truxima in non-oncology indications should contain the following key elements:
Danish: Patientkortet for Truxima for non-onkologiske indikationer skal indeholde følgende nøgle-elementer:
English: Rarely Truxima can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Danish: Truxima har i sjældne tilfælde forårsaget en alvorlig hjerneinfektion, som kaldes ”Progressiv multifokal leukoencefalopati” (PML).
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Truxima or patients refractory to previous Truxima plus chemotherapy.
Danish: Der er kun begrænsede effekt-og sikkerhedsdata tilgængelige for patienter, som tidligere er behandlet med monoklonale antistoffer inklusive Truxima, og for patienter, som er refraktære over for tidligere behandling med Truxima og kemoterapi.
English: Talk to your doctor, pharmacist or nurse before you are given Truxima if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, inden du får Truxima, hvis:
English: Your doctor may need to take special care of you during your treatment with Truxima.
Danish: Du kan have behov for ekstra overvågning under din behandling med Truxima.
English: Risk Reduction1)
Danish: Risikoreduktion1)
English: A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32%.
Danish: En efterfølgende analyse af længden af overlevelsen, udført med en median opfølgningsperiode på 60 måneder, bekræftede fordelene ved R-CHOP behandlingen i forhold til CHOP behandlingen (p = 0,0071), hvilket svarer til en risikoreduktion på 32 %.
English: • infections such as pneumonia (bacterial)
Danish: • infektioner som f.eks. lungebetændelse (bakteriel)
English: In patients where the treatment is working, Truxima may be continued for 2 years after completing the initial treatment.
Danish: Hvis behandlingen virker, kan Truxima fortsættes i 2 år efter, den første behandling er givet.
English: Following induction of remission with Truxima, maintenance treatment should be initiated no sooner than 16 weeks after the last Truxima infusion.
Danish: Efter induktion af remission med Truxima skal vedligeholdelsesbehandling initieres tidligst 16 uger efter sidste Truxima infusion.
English: Kaplan-Meier Estimate of Median Time to Event (months)
Danish: Kaplan-Meier estimat for den mediane tid til hændelsen (måneder)
English: Truxima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Danish: Truxima er indiceret til behandling af tidligere ubehandlede patienter med stadium III-IV follikulært lymfom i kombination med kemoterapi.
English: Granulomatosis with polyangiitis and microscopic polyangiitis Patients treated with Truxima must be given the patient alert card with each infusion.
Danish: Granulomatose med polyangiitis og mikroskopisk polyangiitis Patienter behandlet med Truxima skal have udleveret patientkortet ved hver infusion.
English: Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Danish: Truxima vedligeholdelsesbehandling er indiceret til behandling af follikulært lymfom hos patienter, der responderer på induktionsbehandling.
English: • allergic reactions including wheezing or shortness of breath, swelling of the face and tongue, collapse
Danish: • allergiske reaktioner herunder hvæsende vejrtrækning og åndenød, hævelse af ansigt og tunge, kollaps
English: Aseptically withdraw the necessary amount of Truxima, 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.
Danish: Under anvendelse af aseptiske procedurer trækkes den nødvendige mængde Truxima 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: 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 Truxima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Danish: For CLL-patienter, hvis lymfocyttal er > 25 x 109/l, anbefales det at administrere 100 mg prednison/prednisolon intravenøst kort før infusionen med Truxima for at reducere hastigheden og sværhedsgraden af akutte infusionsreaktioner og/eller cytokinfrigivelsessyndrom.
English: 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)
Danish: 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
English: Safety and efficacy of Truxima have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Danish: Sikkerhed og effekt af Truxima er ikke påvist i kombination med andre kemoterapiregimer til behandling af diffust storcellet B-celle non-Hodgkin-lymfom.
English: Ear and labyrinth tinnitus, ear pain hearing loss5
Danish: Øre og labyrint tinnitus, øresmerter høretab5
English: In patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if Truxima is not given in combination with glucocorticoid-containing chemotherapy.
Danish: Hos patienter med non-Hodgkin-lymfom og CLL bør det overvejes at give præmedicinering med glukokortikoider, hvis Truxima ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
English: Granulomatosis with polyangiitis and microscopic polyangiitis Truxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Danish: Granulomatose med polyangiitis og mikroskopisk polyangiitis Truxima er i kombination med glukokortikoider indiceret til behandling af voksne patienter med svær, aktiv granulomatose med polyangiitis (Wegeners granulomatose) (GPA) eller mikroskopisk polyangiitis (MPA).
English: This medicinal product contains 52.6 mg sodium per 10 mL vial, equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 52,6 mg natrium pr. 10 mL hætteglas, svarende til 2,6% af den WHO anbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: B-lymphocytes are involved in the cause of some of the symptoms you have.
Danish: Blymfocytter er medvirkende til nogle af de symptomer, du har.
English: The Patient information about Truxima should contain the following key elements:
Danish: Information til patienten om Truxima skal indeholde følgende nøgle-elementer:
English: • The active ingredient in Truxima is called rituximab.
Danish: • Aktivt stof i Truxima: Rituximab.
English: The most frequently reported serious infection in the rituximab group was pneumonia at a frequency of 4%.
Danish: Den hyppigst indberettede alvorlige infektion i rituximab gruppen var pneumoni med en forekomst på 4 %.
English: EULAR Response (Good/Moderate)
Danish: EULAR respons (god/moderat) Gennemsnits-ændring i DAS
English: If you are being treated for pemphigus vulgaris
Danish: e) Hvis du behandles for pemfigus vulgaris
English: Risk Reduction
Danish: Risiko reduktion
English: • pain on passing water (urinary tract infection)
Danish: • smerte ved vandladning (urinvejsinfektion)
English: Truxima works best in those who have a positive blood test to rheumatoid factor (RF) and/or for anti-cyclic citrullinated peptide (anti-CCP).
Danish: Den bedste virkning af Truxima ses hos dem, som har en positiv blodprøve for reumafaktor (RF) og/eller for antistoffer mod cyklisk citrullinerede peptider (anti-CCP).
English: If patients did not experience a serious infusion-related reaction with their first or subsequent infusions of a dose of 1000 mg Truxima administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/mL in a 250 mL volume).
Danish: Hvis patienten ikke har oplevet en alvorlig infusionsrelateret reaktion ved den første eller efterfølgende infusioner af en Truxima-dosis på 1.000 mg administreret ud fra den oprindelige infusionstid, kan de efterfølgende infusioner administreres som en hurtigere infusion ved at bruge den samme koncentration som ved tidligere infusioner (4 mg/ml i 250 ml).
English: Patients treated with Truxima must be given the patient alert card with each infusion.
Danish: Patienter behandlet med Truxima skal have udleveret patientkortet ved hver infusion.
English: The prepared Truxima solution should be administered as an intravenous infusion through a dedicated line.
Danish: Den tilberedte Truxima-opløsning skal gives som en intravenøs infusion gennem en separat anlagt intravenøs adgang.
English: No dose reductions of Truxima are recommended.
Danish: Der er ingen anbefalinger vedrørende dosisreduktion af Truxima.
English: Truxima should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Danish: Truxima skal administreres som to 500 mg intravenøse infusioner, med to ugers mellemrum, efterfulgt af en 500 mg intravenøs infusion hver 6. måned.
English: The chemotherapy should be given after the Truxima infusion.
Danish: Kemoterapien skal gives efter infusionen med Truxima.
English: How to store Truxima
Danish: Sådan får du Truxima
English: The recommended dosage of Truxima is 1000 mg by intravenous infusion followed by a second 1000 mg intravenous infusion two weeks later.
Danish: Den anbefalede dosis af Truxima er 1.000 mg ved intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion to uger senere.
English: Truxima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Danish: Truxima er indiceret til behandling af patienter med moderat til svær pemfigus vulgaris (PV).
English: Subsequent doses of Truxima 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.
Danish: Efterfølgende Truxima-doser kan infunderes med 100 mg/time initialt og øges med 100 mg/time hvert 30. minut til højst 400 mg/time.
English: This is because Truxima can across the placenta and may affect your baby.
Danish: Truxima kan overføres til moderkagen og påvirke barnet.
English: Truxima is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Danish: Truxima anvendes til behandling af patienter med moderat til svær pemfigus vulgaris.