FrancophonIA/ELRC3.0 huggingface dataset:
English: Aseptically withdraw the necessary amount of Riximyo, 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 Riximyo 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: Riximyo should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Danish: Riximyo bør ikke administreres til patienter med en aktiv, alvorlig infektion (for eksempel tuberkulose, sepsis og opportunistiske infektioner, se pkt.
English: The Patient educational leaflet about Riximyo contains the following key elements: - Detailed information on the risk of infections and PML - Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any - The importance of sharing this information with their partner or caregiver - Information on the Patient Alert Card
Danish: Undervisningsbrochuren til patienter om Riximyo skal indeholde følgende nøgle-elementer: - Detaljeret information om risikoen for infektioner og PML - Information om symptomer på infektioner, især PML, og nødvendigheden af at kontakte deres læge straks, hvis de får nogle symptomer - Vigtigheden af at dele denne information med deres evt. partner eller omsorgsperson - Informationen på patientkortet
English: Table 10b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time
Danish: Tabel 10b Førstelinjebehandling af kronisk lymfatisk leukæmi Hazard ratioer for progressionsfri overlevelse efter Binet stadium (ITT) - median observationstid: 48,1 måneder
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 Riximyo 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 Riximyo for at reducere hastigheden og sværhedsgraden af akutte infusionsreaktioner og/eller cytokinfrigivelsessyndrom.
English: Chemical and physical stability of Riximyo diluted in 0.9% sodium chloride solution has been demonstrated for 30 days at 2°C - 8°C and subsequently 24 hours at room temperature (≤25°C).
Danish: Kemisk og fysisk stabilitet af Riximyo, der er fortyndet i 0,9 % natriumchloridopløsning, er blevet påvist i 30 dage ved 2 °C - 8 °C og efterfølgende 24 timer ved stuetemperatur (≤25 °C).
English: This is because some people have a fall in their blood pressure while they are being given Riximyo.
Danish: Nogle har oplevet, at blodtrykket faldt, mens de fik Riximyo
English: Respiratory system Cases of interstitial lung disease, some with fatal outcome have been reported.
Danish: Tilfælde af interstitiel lungesygdom, hvoraf nogle med dødelig udgang, er blevet rapporteret.
English: This is because Riximyo can cross the placenta and may affect your baby.
Danish: Riximyo kan passere moderkagen og påvirke barnet.
English: 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 2).
Danish: 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 af rituximab sammenlignet med patienter behandlet med standarddosis prednison over behandlingsperioden på 24 måneder (figur 2).
English: • Riximyo will be given to you on the same day as your chemotherapy.
Danish: • Riximyo gives samme dag som kemoterapien.
English: The prepared Riximyo solution should be administered as an intravenous infusion through a dedicated line.
Danish: Den tilberedte Riximyo-opløsning skal gives som en intravenøs infusion gennem en separat anlagt intravenøs adgang.
English: Riximyo is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Danish: Riximyo er indiceret til behandling af tidligere ubehandlede patienter med stadium III-IV follikulært lymfom i kombination med kemoterapi.
English: Riximyo 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: Riximyo skal administreres som to 500 mg intravenøse infusioner, med to ugers mellemrum, efterfulgt af en 500 mg intravenøs infusion hver 6. måned.
English: Preparation should be: - performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Danish: Tilberedningen skal: - udføres under aseptiske forhold af uddannet personale i henhold til regler om god praksis, særligt med hensyn til den aseptiske tilberedning af parenterale lægemidler - tilberedes i et aftræksskab med laminært airflow eller i et biologisk sikkerhedsskab, idet der tages forholdsregler for sikker håndtering af intravenøse midler.
English: Granulomatosis with polyangiitis and microscopic polyangiitis Patients treated with Riximyo must be given the patient alert card with each infusion.
Danish: Granulomatose med polyangiitis og mikroskopisk polyangiitis Patienter behandlet med Riximyo skal have udleveret patientkortet ved hver infusion.
English: You will always be given Riximyo as a drip (intra-venous infusion).
Danish: Riximyo gives altid i et drop (intravenøs infusion).
English: Before you are given Riximyo you will be given other medicines (premedication) to prevent or reduce possible side effects.
Danish: Medicin, der gives inden hver behandling med Riximyo Inden du får Riximyo, vil du få anden medicin (præmedicin), der forebygger eller mindsker mulige bivirkninger.
English: Patients treated with Riximyo must be given the patient alert card with each infusion.
Danish: Patienter behandlet med Riximyo skal have udleveret patientkortet ved hver infusion.
English: Riximyo is a clear, colourless to slightly yellowish solution, supplied as a concentrate for solution for infusion.
Danish: Riximyo er en klar, farveløs til let gullig opløsning, leveret som koncentrat til infusionsvæske, opløsning.
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of Riximyo.
Danish: Lægemidler til behandling af hypersensitivitetsreaktioner, for eksempel epinephrin (adrenalin), antihistaminer og glukokortikoider, bør være tilgængelige til øjeblikkelig anvendelse, i tilfælde af en allergisk reaktion under administration af Riximyo.
English: In case of such an event with a suspected relationship to Riximyo, treatment should be permanently discontinued.
Danish: Hvis en sådan bivirkning skulle opstå med formodet relation til Riximyo, skal behandlingen seponeres permanent.
English: Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with Riximyo.
Danish: Alle patienter bør screenes for hepatitis B-virus (HBV) før påbegyndelse af behandling med Riximyo.
English: Adverse drug reaction rituximab + low-dose prednisone (n = 38)
Danish: Systemorganklasse Bivirkning rituximab + lavdosis prednison (n = 38)
English: Table 13 Complete remission at 6-months by disease status Rituximab Cyclophosphamide Difference (CI 95%)
Danish: Tabel 13 Fuldstændig remission ved måned 6 opgjort efter sygdomsstatus Rituximab Cyclophosphamid
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials
Danish: 1 Hyppigheden stammer fra laboratorie-værdier, som var indsamlet som en del af rutinemæssig laboratorie-overvågning i kliniske studier 2 Hyppigheden stammer fra data efter markedsføring
English: Riximyo maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Danish: Riximyo vedligeholdelsesbehandling er indiceret til behandling af follikulært lymfom hos patienter, der responderer på induktionsbehandling.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1,000 mg per day is recommended prior to the first infusion of Riximyo (the last dose of methylprednisolone may be given on the same day as the first infusion of Riximyo).
Danish: Hos patienter med GPA eller MPA anbefales det at give methylprednisolon intravenøst i 1-3 dage i en dosis på 1.000 mg pr. dag inden den første Riximyo-infusion (sidste dosis methylprednisolon kan gives samme dag som første Riximyo-infusion).
English: Clinical laboratory findings
Danish: Kliniske laboratoriefund
English: Three patients (8%) in the rituximab group experienced a total of 5 serious infections (Pneumocystis jirovecii pneumonia, infective thrombosis, intervertebral discitis, lung infection, Staphylococcal sepsis) and one patient (3%) in the standard-dose prednisone group experienced a serious infection (Pneumocystis jirovecii pneumonia).
Danish: 5 alvorlige infektioner (Pneumocystis jiroveci-pneumoni, infektiøs trombose, intervertebral diskitis, lungeinfektion, Staphylococcal-sepsis) og 1 patient (3 %) i standarddosis prednison-gruppen oplevede 1 alvorlig infektion (Pneumocystis jiroveci-pneumoni).
English: d) If you are being treated for pemphigus vulgaris
Danish: d) Hvis du behandles for pemfigus vulgaris
English: Other medicines and Riximyo
Danish: Brug af anden medicin sammen med Riximyo
English: Your doctor may need to take special care of you during your treatment with Riximyo.
Danish: Du kan have behov for ekstra overvågning under din behandling med Riximyo.
English: If you have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
Danish: Hvis du har granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris fortæl da også din læge
English: Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the Riximyo infusion.
Danish: Eftersom hypotension kan forekomme under administration af rituximab, bør det overvejes at afbryde behandling med antihypertensive lægemidler 12 timer før infusion med Riximyo.
English: The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group
Danish: Den samlede responsrate efter behandlingsserie 8 var 76,2 % i R-CHOP gruppen sammenlignet med 62,4 % i CHOP gruppen (p=0,0028).
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to < 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Danish: Hos patienter med GPA eller MPA faldt antallet af B-celler i perifert blod til < 10 celler/mikroliter efter 2 ugentlige infusioner af rituximab 375 mg/m2 og forblev på dette niveau hos de fleste patienter til måned 6.
English: Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal products 12 hours prior to the Riximyo infusion.
Danish: Da hypotension kan forekomme under infusion med rituximab, bør det overvejes at seponere antihypertensiva i 12 timer før Riximyoinfusionen.
English: This is because in a few cases, Riximyo could cause hepatitis B to become active again, which can be fatal in very rare cases.
Danish: Det er vigtigt, fordi Riximyo i enkelte tilfælde har forårsaget, at en tidligere leverbetændelse (hepatitis B) er blevet aktiv igen.
English: Figure 2: Number of patients who were off or on minimal corticosteroid (≤10mg/day) therapy over time
Danish: Antallet af patienter uden kortikosteroid-behandling eller behandlet med minimalt kortikosteroid (≤ 10 mg/dag) over tid
English: In patients with non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, premedication with glucocorticoids should be considered if Riximyo is not given in combination with glucocorticoid-containing chemotherapy.
Danish: Hos patienter med non-Hodgkin-lymfom CLL bør det overvejes at give præmedicinering med glukokortikoider, hvis Riximyo ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
English: The recommended dosage of Riximyo for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Danish: Den anbefalede dosis af Riximyo til behandling af PV er 1.000 mg administreret som en intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion 2 uger senere i kombination med nedtitrerende glukokortikoider.
English: Talk to your doctor, pharmacist or nurse before you are given Riximyo if:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, inden du får Riximyo, hvis:
English: In patients where the treatment is working, Riximyo may be used as a maintenance treatment for 2 years after completing the initial treatment.
Danish: Hvis behandlingen virker, kan Riximyo gives som vedligeholdelsesbehandling i 2 år efter, den første behandling er givet.
English: Riximyo is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Danish: Riximyo leveres i sterile, pyrogenfri hætteglas uden konserveringsmiddel til engangsbrug.
English: Riximyo is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Danish: Riximyo anvendes til behandling af patienter med moderat til svær pemfigus vulgaris.
English: Riximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Danish: Riximyo er indiceret til behandling af patienter med moderat til svær pemfigus vulgaris (PV).
English: When you are treated with Riximyo in combination with chemotherapy, you will receive Riximyo infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
Danish: b) Hvis du behandles for kronisk lymfatisk leukæmi Hvis du behandles med Riximyo i kombination med kemoterapi, vil du få en infusion med Riximyo på dag 0 i serie 1 og derefter på dag 1 i hver af i alt 6 serier.
English: The chemotherapy should be given after the Riximyo infusion.
Danish: Kemoterapien skal gives efter infusionen med Riximyo.
English: You must also do this for 12 months after your last treatment with Riximyo.
Danish: I skal fortsætte med sikker prævention i 12 måneder efter din sidste behandling med Riximyo.
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of Riximyo and anti-rheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Danish: Samtidig anvendelse af Riximyo og andre antireumatiske behandlinger, end dem der er specificeret under reumatoid artrit-indikation og dosering, anbefales ikke.
English: Riximyo monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
Danish: Riximyo 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: Physicians should exercise caution when considering the use of Riximyo in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
Danish: Læger bør udvise forsigtighed, når de overvejer brugen af Riximyo til patienter, der tidligere har haft recidiverende eller kroniske infektioner eller patienter med tilgrundliggende forhold, der yderligere kan prædisponere dem til alvorlig infektion (se pkt.
English: What you need to know before you are given Riximyo Do not take Riximyo if
Danish: Det skal du vide, før du begynder at få Riximyo Sådan gives Riximyo
English: Table 14 Percentage of PV patients who achieved complete remission off corticosteroid therapy for two months or more at month 24 (Intent-to-Treat Population - PV)
Danish: Tabel 14 Procentdel af patienter med PV, som opnåede fuldstændig remission uden kortikoid-behandling i to eller flere måneder ved måned 24 (ITT-population - PV) Rituximab + Prednison N = 38
English: Riximyo can be given alone or with other medicines called “chemotherapy”.
Danish: Riximyo kan anvendes alene eller sammen med kemoterapi.
English: Response rate and CR rates analysed using Chi-squared Test. *: only applicable to patients achieving a CR, nPR, PR; NR: not reached n.a. not applicable **: only applicable to patients achieving a CR;
Danish: *: gælder kun for patienter, som opnåede CR, nPR eller PR; NR: ikke nået; n.a.: ikke relevant **: gælder kun for patienter, som opnåede CR
English: You might get infections more easily during your treatment with Riximyo.
Danish: Risikoen for infektioner kan øges under behandling med Riximyo.
English: Granulomatosis with polyangiitis and microscopic polyangiitis Riximyo, 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: Riximyo 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: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Riximyo Alert Card for patients with non-oncology diseases
Danish: Riximyo-patientkort for ikke-onkologiske indikationer
English: c) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Danish: b) Hvis du behandles for granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: The recommended dosage of Riximyo in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Danish: Den anbefalede dosis af Riximyo i kombination med kemoterapi til tidligere ubehandlede patienter og til relaps/refraktære patienter er 375 mg/m2 legemsoverflade, som gives på dag 0 af første behandlingsserie, efterfulgt af 500 mg/m2 legemsoverflade på dag 1 af hver af de følgende serier, i alt 6 serier.
English: Riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia.
Danish: Riximyo er i kombination med kemoterapi indiceret til behandling af kronisk lymfatisk leukæmi hos patienter, som ikke tidligere er behandlet, og til patienter med relaps/refraktær kronisk lymfatisk leukæmi.
English: This is because Riximyo can affect the way some other medicines work.
Danish: Det er vigtigt, da Riximyo kan påvirke virkningen af anden medicin, og anden medicin kan påvirke virkningen af Riximyo.
English: Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Danish: Anvendelse af rituximab hos patienter, som ikke tidligere har været behandlet med MTX, anbefales ikke, da et favorabelt risk/benefit-forhold ikke er blevet fastlagt.
English: Injury, poisoning and procedural complications
Danish: Skader, forgiftninger og proceduremæssige komplikationer Infusionsrelaterede reaktioner2
English: Herpes zoster Nasopharyngitis
Danish: Herpes zoster
English: How to store Riximyo
Danish: Sådan gives Riximyo
English: d) Pemphigus vulgaris
Danish: d) Pemfigus vulgaris
English: Description of selected adverse reactions
Danish: Beskrivelse af udvalgte bivirkninger Infusionsrelaterede reaktioner
English: All patients treated with Riximyo for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris must be given the patient alert card with each infusion.
Danish: Alle patienter behandlet med Riximyo for reumatoid artrit, GPA, MPA eller PV skal have udleveret patientkortet ved hver infusion.
English: Rituximab may have a minor influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Rituximab kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: The recommended dosage of Riximyo for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Danish: Den anbefalede dosis af Riximyo til induktion af remission af GPA og MPA er 375 mg/m2 legemsoverfladeareal, administreret som intravenøs infusion, én gang ugentligt i 4 uger (4 infusioner i alt).
English: The recommended dose of Riximyo monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
Danish: Den anbefalede dosis af Riximyo monoterapi til induktionsbehandling hos voksne patienter med grad III-IV follikulært lymfom, som er resistente over for behandling med kemoterapi eller som er i deres anden eller efterfølgende recidiv efter kemoterapi, er 375 mg/m2 legemsoverfladeareal, givet som intravenøs infusion én gang ugentligt i 4 uger.
English: Riximyo is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Danish: Riximyo er, i kombination med CHOP-kemoterapi (cyclophosphamid, doxorubicin, vincristin og prednisolon), indiceret til behandling af patienter med CD20 positivt, diffust storcellet B-celle non-Hodgkin-lymfom.
English: The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema,
Danish: Det akutte respirationssvigt kan ledsages af f.eks. interstitiel lungeinfiltration eller lungeødem som kan ses på røntgen af thorax.
English: Riximyo 100 mg concentrate for solution for infusion Each 10 mL vial contains 100 mg of rituximab.
Danish: Riximyo 100 mg koncentrat til infusionsvæske, opløsning Hvert 10 ml hætteglas indeholder 100 mg rituximab.
English: Riximyo 500 mg concentrate for solution for infusion Each 50 mL vial contains 500 mg of rituximab.
Danish: Riximyo 500 mg koncentrat til infusionsvæske, opløsning Hvert 50 ml hætteglas indeholder 500 mg rituximab.
English: Follicular lymphoma
Danish: Follikulært lymfom Monoterapi
English: Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift.
English: Riximyo 100 mg concentrate for solution for infusion Riximyo 500 mg concentrate for solution for infusion
Danish: Riximyo 100 mg koncentrat til infusionsvæske, opløsning Riximyo 500 mg koncentrat til infusionsvæske, opløsning
English: Riximyo
Danish: Rhinitis
English: The two treatment groups were well balanced with regards to baseline characteristics and disease status.
Danish: De to behandlingsgrupper var velbalancerede i forhold til baselinekarakteristika og sygdomsstatus.