FrancophonIA/ELRC3.0 huggingface dataset:
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.
Danish: Der er kun begrænsede effekt- og sikkerhedsdata tilgængelige for patienter, som tidligere er behandlet med monoklonale antistoffer inklusive MabThera, og for patienter, som er refraktære over for tidligere behandling med MabThera og kemoterapi.
English: 4 Possible side effects
Danish: 4 Bivirkninger
English: In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
Danish: I det kliniske studie med induktion af remission blev kardielle bivirkninger rapporteret med en hyppighed på ca. 273 pr. 100 patientår (95% konfidensinterval 149-470) ved det primære endepunkt ved måned 6.
English: A total of 23/99 (23%) MabThera-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Danish: I alt 23/99 (23%) af de MabThera-behandlede patienter i studiet med induktion af remission blev testet positive for ADA ved måned 18.
English: Rituximab has shown to be highly specific to the CD20 antigen on B cells.
Danish: Rituximab er vist at være yderst specifikt over for CD20-antigenet på B-celler.
English: These events were Grade 4 thrombocytopenia and Grade 3 anxiety, injection-site erythema and urticaria.
Danish: Disse bivirkninger var grad 4 trombocytopeni og grad 3 angst, erytem ved injektionsstedet og urticaria.
English: Your doctor will decide when to start MabThera injections.
Danish: Lægen beslutter, hvornår du skal skifte til MabThera som indsprøjtning.
English: 50 mL vial - Pack of 1 vial
Danish: 50 ml hætteglas - pakninger med 1 hætteglas
English: An analysis of overall survival confirmed the significant benefit of MabThera maintenance over observation (p=0.0039 log-rank test).
Danish: En analyse af den samlede overlevelse bekræftede den signifikante fordel af MabThera vedligeholdelse fremfor observation (p=0,0039 log-rank test).
English: InSABRINA, severe administration-related reactions (grade≥3) were reported in two patients (2%) following administration of MabThera subcutaneous formulation.
Danish: I SABRINA rapporteredes svære administrationsrelaterede reaktioner (grad ≥3) hos 2 patienter (2 %) efter subkutan administration af MabThera.
English: CR rates n.a.
Danish: CR-rater n.a.
English: Blood and lymphatic system disorders neutropenia1
Danish: Blod og lymfesystem neutropeni sen neutropeni2
English: Higher frequencies of infections overall, including grade 3 or 4 infections, were observed during MabThera maintenance treatment up to 2 years when compared to observation.
Danish: Der blev set højere infektionshyppighed, herunder infektioner af grad 3 eller 4, under MabThera vedligeholdelsesbehandling i op til 2 år sammenlignet med observationsgruppen.
English: Severe infections were reported in about 4% of patients treated with MabThera monotherapy.
Danish: Der blev rapporteret om svære infektioner hos ca. 4 % af de patienter, der blev behandlet med MabThera monoterapi.
English: Animal studies did not reveal deleterious effects of rituximab or recombinant human hyaluronidase (rHuPH20) on reproductive organs.
Danish: Dyrestudier har ikke afsløret, at rituximab eller rekombinant humant hyaluronidase (rHuPH20) skulle have skadelig effekt på reproduktionsorganer.
English: MabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Danish: MabThera vedligeholdelsesbehandling er indiceret til behandling af follikulært lymfom hos patienter, der responderer på induktionsbehandling.
English: In SAWYER trial (BO25341) the incidence of treatment-induced/enhanced anti-rituximab antibodies was similar in the two treatment arms; 15% intravenous vs. 12% subcutaneous.
Danish: I SAWYER-studiet (BO25341) var forekomsten af behandlingsinducerede/forhøjede anti-rituximab-antistoffer sammenlignelig i de to behandlingsarme, henholdsvis 15 % for intravenøs versus 12 % for subkutan.
English: The Patient information about MabThera should contain the following key elements:
Danish: Information til patienten om MabThera skal indeholde følgende nøgle-elementer:
English: • The active ingredient is rituximab.
Danish: • Aktivt stof: Rituximab.
English: In the overall experience of MabThera 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 MabThera 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 baseline.
English: Rarely MabThera can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Danish: MabThera har i sjældne tilfælde forårsaget en alvorlig hjerneinfektion, som kaldes ”Progressiv multifokal leukoencefalopati” (PML).
English: InSparkThera, no severe administration-related reactions were reported.
Danish: I SparkThera rapporteredes ingen svære administrationsrelaterede reaktioner.
English: Vascular disorders hypertension, orthostatic hypotension, hypotension vasculitis (predominatel y cutaneous), leukocytoclast ic vasculitis
Danish: Vaskulære sygdomme hypertension, orthostatisk hypotension, hypotension vasculitis (fortrinsvis kutan), leukocytoklastisk vasculitis
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and very rare (<1/10,000).
Danish: Hyppigheden defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000
English: Each mL contains 120 mg of rituximab.
Danish: Hver ml indeholder 120 mg rituximab.
English: MabThera is a clear, colourless solution, supplied as a concentrate for solution for infusion.
Danish: MabThera er en klar, farveløs opløsning, leveret som koncentrat til infusionsvæske, opløsning.
English: In the maintenance therapy clinical trial, 7/57 (12%) patients in the MabThera arm experienced at least one infusion-related reaction.
Danish: I det kliniske studie med vedligeholdelsesbehandling oplevede 7 ud af 57 (12 %) patienter i MabThera-armen mindst én infusionsrelateret reaktion.
English: The overall safety profile of MabThera in non-Hodgkin's lymphoma and CLL is based on data from patients from clinical trials and from post-marketing surveillance.
Danish: MabThera's sikkerhedsprofil ved non-Hodgkin-lymfom og CLL er baseret på data fra patienter fra kliniske studier og fra post-marketing overvågning.
English: Subcutaneous injections
Danish: Subkutan injektion
English: The benefit in terms of PFS was consistently observed in most patient subgroups analysed according to disease risk at baseline (i.e. Binet stages A-C) (Table 2b).
Danish: Fordelen med hensyn til PFS blev konsistentobserveret i de fleste patientundergrupper, som blev analyseret i forhold til sygdomsrisikoen ved baseline (dvs. Binet stadium A-C) (tabel 2b).
English: MabThera, 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: MabThera 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: MabThera 1400 mg is used to treat Non-Hodgkin's lymphoma in adults.
Danish: MabThera 1400 mg anvendes til behandling af non-Hodgkin-lymfom hos voksne.
English: This sticker should be removed from the vial and stuck onto the syringe prior to use.
Danish: Klistermærket skal fjernes fra hætteglasset og skal påsættes sprøjten inden brug.
English: No incompatibilities between MabThera subcutaneous formulation and polypropylene or polycarbonate syringe material or stainless steel transfer and injection needles and polyethylene Luer cone stoppers have been observed.
Danish: Der er ikke observeret uforligelighed mellem MabThera subkutan formulering og polypropylen- eller polycarbonatmaterialet i sprøjter eller rustfrit stål i injektionsnåle og polyethylen-Luer-propper.
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, anæmi hos 1,1 %, og svær trombocytopeni hos 1,7 %.
English: METHOD OF ADMINISTRATION Only for subcutaneous use
Danish: ADMINISTRATIONSMETODE Udelukkende til subkutan anvendelse.
English: MabThera + low-dose prednisone (n = 38)
Danish: MabThera + lavdosis prednison (n = 38)
English: In the maintenance therapy clinical trial, 30/57 (53%) patients in the MabThera arm experienced infections.
Danish: I det kliniske studie med vedligeholdelsesbehandling oplevede 30 ud af 57 (53 %) patienter i MabThera-armen infektioner.
English: A two-stage phase III, international, multi-centre, randomised, controlled, open-label trial was conducted in patients with previously untreated follicular lymphoma, to investigate the non-inferiority of the pharmacokinetic profile, together with efficacy and safety of MabThera subcutaneous formulation in combination with CHOP or CVP versus MabThera intravenous formulation in combination with CHOP or CVP.
Danish: Der er gennemført et internationalt, randomiseret, kontrolleret, åbent, 2-delt fase III-multicenterstudie med patienter med tidligere ubehandlet follikulært lymfom med henblik på at undersøge noninferiøritet af farmakokinetisk profil, virkning og sikkerhed for MabThera subkutan formulering i kombination med CHOP eller CVP versus MabThera intravenøs formulering i kombination med CHOP eller CVP.
English: Patients treated with MabThera must be given the patient alert card with each infusion.
Danish: Patienter behandlet med MabThera skal have udleveret patientkortet ved hver infusion.
English: Patients achieving at least PR were entered on MabThera intravenous formulation maintenance therapy once every 8 weeks for 24 months.
Danish: Patienter med mindst PR overgik til vedligeholdelsesbehandling med MabThera intravenøs formulering, én gang hver 8. uge i 24 måneder.
English: 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.
Danish: 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).
English: PFS - Progression-Free Survival (proportion with event, disease progression/relapse or death from any cause) a - at 3 month follow-up visit (Part 2) b - at time of final analysis (median follow-up 53 months)
Danish: Progressionsfri overlevelse (andel med tilfælde, sygdomsprogression/recidiv eller død af enhver årsag) a - ved 3 måneders opfølgningsbesøg (2. del) b - ved tidspunktet for den endelige analyse (median opfølgning 53 måneder)
English: Patients achieving at least partial response (PR) were entered on the MabThera subcutaneous formulation maintenance therapy once every 8 weeks for 24 months.
Danish: Patienter med mindst partielt respons (PR) overgik til vedligeholdelsesbehandling med MabThera subkutan formulering, én gang hver 8. uge i 24 måneder.
English: The risk of acute administration-related reactions associated with the subcutaneous formulation of MabThera was assessed in two open-label trials involving patients with follicular lymphoma during induction and maintenance (SABRINA/BO22334) and during maintenance only (SparkThera/BP22333).
Danish: Risikoen for akutte administrationsrelaterede reaktioner i forbindelse med den subkutane formulering af MabThera er vurderet i 2 åbne kliniske studier med patienter med follikulært lymfom under induktions- og vedligeholdesesbehandling (SABRINA/BO22334) og under vedligeholdelsesbehandling alene (SparkThera/BP22333).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use only
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Udelukkende til subkutan anvendelse.
English: This is because MabThera can cross the placenta and may affect your baby.
Danish: MabThera kan passere moderkagen og påvirke barnet.
English: Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2mg/kg/day) for 3-6 months or MabThera (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 MabThera (375 mg/m2) én gang ugentligt i 4 uger.
English: When injected under your skin, it is given in the stomach area, not in other sites of the body, and not into areas of the stomach where the skin is red, bruised, tender, hard or where there are moles or scars.
Danish: Indsprøjtningen under huden gives altid i maven, og må ikke gives i andre områder af kroppen, og ikke hvor huden er rød, øm, hård eller i et blåt mærke, skønhedsplet eller ar.
English: This set of reactions which includes syndrome of cytokine release, tumor lysis syndrome and anaphylactic and hypersensitivity reactions are described below.
Danish: Det sæt af reaktioner, der omfatter cytokinfrigivelsessyndrom, tumorlysesyndrom samt anafylaktiske reaktioner og overfølsomhedsreaktioner beskrives nedenfor.
English: Events seen following subcutaneous administration were mild or moderate, apart from one patient who reported a local cutaneous reaction of Grade 3 intensity (injection site rash) following the first MabThera subcutaneous administration (Cycle 2).
Danish: Bivirkninger set efter subkutan administration var lette eller moderate, bortset fra én patient, som rapporterede et tilfælde af lokal hudreaktion af grad 3 (udslæt ved injektionsstedet) efter den første subkutane MabThera-injektion (2. serie).
English: MabThera 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: MabThera skal administreres som to 500 mg intravenøse infusioner, med to ugers mellemrum, efterfulgt af en 500 mg intravenøs infusion hver 6. måned.
English: B-cell levels in human neonates following maternal exposure to MabThera have not been studied in clinical trials.
Danish: B-celle niveauer i spædbørn efter moderen havde været eksponeret for MabThera, er ikke undersøgt i kliniske studier.
English: For subjects weighing > 90 kg, Ctrough values were the same for the intravenous and subcutaneous regimens.
Danish: For patienter, der vejer > 90 kg, var værdierne for Ctrough ens, for det subkutane og det intravenøse doserings-regime.
English: PFS - Progression-Free Survival (proportion with event, disease progression/relapse or death from any cause) a - at end of Induction b - at time of final analysis (median follow-up 58 months)
Danish: Progressionsfri overlevelse (andel med tilfælde, sygdomsprogression/recidiv eller død af enhver årsag) a - ved slutning af induktion b - ved tidspunktet for den endelige analyse (median opfølgning 58 måneder)
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 1000 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: Measure blood neutrophils prior to each course of MabThera, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Danish: Neutrofiltælling bør foretages inden hver MabThera behandlingsserie og regelmæssigt op til 6 måneder efter afsluttet behandling, samt ved tegn på infektion (se pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 MabThera once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Danish: Baseret på den farmakokinetiske populationsanalyse af data fra 97 patienter med GPA eller MPA, der fik 375 mg/m2 MabThera én gang ugentligt i 4 uger, var den estimerede mediane terminale halveringstid 23 dage (9-49 dage).
English: Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
Danish: Alvorlige infektioner, inklusive fatale tilfælde, kan forekomme under behandlingsforløbet med MabThera (se pkt.
English: MabThera contains sodium
Danish: MabThera indeholder natrium
English: Should non-live vaccinations be required whilst receiving MabThera therapy, these should be completed at least 4 weeks prior to commencing the next course of MabThera.
Danish: Hvis vaccination med ikke levende vacciner er nødvendig samtidig med behandling med MabThera, bør vaccinationerne være gennemført mindst 4 uger inden næste behandling med MabThera.
English: Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of MabThera and anti-rheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
Danish: Samtidig/fortløbende anvendelse af andre DMARDs hos patienter med reumatoid artrit Samtidig anvendelse af MabThera og andre antireumatiske behandlinger, end dem der er specificeret under reumatoid artrit-indikation og dosering, anbefales ikke.
English: The median Tmax in the MabThera subcutaneous formulation was approximately 3 days as compared to the Tmax occuring at or close to the end of the infusion for the intravenous formulation.
Danish: Median Tmax for MabThera i subkutan formulering var ca. 3 dage sammenlignet med, at Tmax opstod ved eller tæt på slutningen af infusionen ved intravenøs formulering.
English: In the majority of these cases, MabThera was administered with chemotherapy.
Danish: I de fleste tilfælde blev MabThera givet sammen med kemoterapi.
English: In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg MabThera separated by a 14 day interval.
Danish: Hos patienter med reumatoid artrit sås øjeblikkelig B-celle depletering i perifert blod efter to infusioner af 1.000 mg MabThera med 14 dages interval.
English: • Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
Danish: • Kronisk lymfatisk leukæmi er den mest almindelige form for leukæmi hos voksne.
English: • Cardiovascular events, see section 4.4.
Danish: • Kardiovaskulære sygdomme, se pkt 4.4.
English: B cell counts returned to normal in these animals within 6 months of birth and did not compromise the reaction to immunization.
Danish: B-celle niveauet normaliseredes hos disse dyr indenfor 6 måneder efter fødslen og påvirkede ikke vaccinationsreaktionen.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: L-histidine hydrochloride monohydrate α,α-trehalose dihydrate L-methionine
Danish: L-histidin hydrochloridmonohydrat α,α-trehalosedihydrat
English: Figure 4: 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 (≤ 10mg/dag) over tid
English: However with non-live vaccines response rates may be reduced.
Danish: Dog kan respons efter vaccination med ikke-levende vacciner være nedsat.
English: When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied (see section 4.8).
Danish: Når MabThera gives i kombination med kemoterapi, bør standard dosisreduktioner for de kemoterapeutiske lægemidler anvendes (se pkt.
English: The clinical relevance of the development of anti-rituximab or anti-rHuPH20 antibodies after treatment with MabThera subcutaneous formulation is not known.
Danish: Den kliniske relevans af udviklingen af anti-rituximab eller anti-rHuPH20-antistoffer efter behandling med MabThera subkutan formulering er ukendt.
English: The recommended dosage of MabThera is 1000 mg by intravenous infusion followed by a second 1000 mg intravenous infusion two weeks later.
Danish: Den anbefalede dosis af MabThera er 1.000 mg ved intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion to uger senere.
English: The incidence of thrombocytopenia was low (<1 %, grade 3/4) and was not different between treatment arms.
Danish: Hyppigheden af trombocytopeni var lav (< 1, grad 3/4), og der var ingen forskel mellem behandlingsarmene.
English: The reactions occurring within 24 hours of the subcutaneous injection consisted primarily of erythema pruritus, rash and injections site reactions such as pain, swelling and redness and were generally of mild or moderate (grade 1 or 2) and transient nature (see section 4.8).
Danish: Reaktionerne opstod inden for 24 timer efter den subkutane injektion og bestod primært i erythema, kløe, udslæt og reaktioner ved injektionsstedet, fx smerter, hævelse og rødme, og var generelt af mild til moderat (grad 1 eller 2) og forbigående natur (se pkt.
English: The most common infections in the MabThera arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster.
Danish: De mest almindelige infektioner i MabThera-armen inkluderede øvre luftvejsinfektioner, gastroenteritis, urinvejsinfektioner og herpes zoster.
English: The safety profile of MabThera in patients with PV was consistent with that observed in RA and GPA/MPA patients.
Danish: Sikkerhedsprofilen for MabThera hos patienter med PV var sammenlignelig med den observeret hos patienter med reumatoid artrit og GPA/MPA.
English: The most common infections in the MabThera group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Danish: De mest almindelige infektioner i MabThera-gruppen var herpes simplex og zoster infektioner, bronkitis, urinvejsinfektion, svampeinfektion og konjunktivitis.
English: In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
Danish: Infusionsrelaterede reaktioner i det kliniske studie, hvor man så på induktion af remission hos patienter med svær, aktiv GPA eller MPA blev defineret som enhver bivirkning, der opstod inden for 24 timer efter en infusion i sikkerhedspopulationen, og som af investigator blev anset som værende infusionsrelateret.
English: Specific studies to determine the effects of rituximab or rHuPH20 on fertility have not been performed.
Danish: Der er ikke gennemført specifikke studier til at fastlægge rituximab eller rHuPH20s effekt på fertiliteten.
English: Most adverse events in the MabThera arm were mild or moderate in intensity.
Danish: De fleste bivirkninger i MabThera-armen var lette til moderate i intensitet.
English: In the phase 3 SABRINA trial (BO22334), local cutaneous reaction were reported in up to 20% of patients receiving subcutaneous MabThera.
Danish: I fase III-studiet SABRINA (BO22334) blev lokale hudreaktioner rapporteret hos op til 20 % af de patienter, der fik subkutan MabThera.