FrancophonIA/ELRC3.0 huggingface dataset:
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 10a).
Danish: Analyse af samlet overlevelse viste fortsat en signifikant fordel ved R-FC-behandling i forhold til FCkemoterapi (p=0,0319, log-rank test) (tabel 10a).
English: MabThera was administered at a dosage of 375 mg/m2 during the first cycle one day prior to chemotherapy and at a dosage of 500 mg/m2 on day 1 of each subsequent treatment cycle.
Danish: MabThera blev givet i en dosis på 375 mg/m2 i første serie en dag før kemoterapi og i en dosis på 500 mg/m2 på dag 1 i hver af de efterfølgende behandlingsserier.
English: 2 vials of 10 mL
Danish: 2 hætteglas á 10 ml
English: MARKETING AUTHORISATION NUMBER(S) MabThera 100 mg concentrate for solution for infusion EU/1/98/067/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) MabThera 100 mg koncentrat til infusionsvæske, opløsning EU/1/98/067/001
English: Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61 % with MabThera maintenance treatment when compared to observation (95 % CI; 45 %-72 %).
Danish: Ved anvendelse af Cox regressionsanalyse var risiko for forekomst af progressiv sygdom eller død reduceret med 61 % med MabThera vedligeholdelsesbehandling sammenlignet med observation (95 % konfidensinterval: 45 %-72 %).
English: The objective of stage 2 was to provide additional efficacy and safety data for subcutaneous rituximab compared with rituximab intravenous using the 1400 mg subcutaneous dose established in stage 1.
Danish: Formålet med andet stadie var at fremskaffe yderligere data for virkning og sikkerhed af subkutant rituximab sammenlignet med intravenøst rituximab.
English: This medicinal product contains less than 1mmol sodium per dose, i.e. essentially sodium free.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with MabThera.
Danish: Alle patienter bør screenes for hepatitis B virus (HBV) før påbegyndelse af behandling med MabThera.
English: In patients with relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary infection) was 2% in R-FC vs 0% FC.
Danish: Hos patienter med relaps/refraktær CLL var incidensen af hepatitis B-infektioner af grad 3/4 (reaktivering og primær infektion) 2 % for R-FC regimet versus 0 % for FC regimet.
English: The most frequently observed adverse drug reactions (ADRs) in patients receiving MabThera were infusion-related reactions which occurred in the majority of patients during the first infusion.
Danish: De hyppigst observerede bivirkninger hos patienter, som fik MabThera var infusionsrelaterede reaktioner, som forekom hos de fleste patienter under første infusion.
English: Table 6 Summary of key results from four phase III randomised studies evaluating the benefit of MabThera with different chemotherapy regimens in follicular lymphoma
Danish: Tabel 6 Opsummering af nøgleresultater fra fire fase-III-randomiserede studier, der evaluerer fordelene ved MabThera med forskellige kemoterapibehandlinger ved follikulært lymfom
English: Rituximab pharmacokinetics following single dose administration of MabThera subcutaneous 375 mg/ m2, 625 mg/ m2 and 800 mg/ m2 were compared with MabThera intravenous 375 mg/ m2 in FL
Danish: Rituximabs farmakokinetik efter administration af enkeltdosis MabThera subkutan 375 mg/ m mg/m2 og 800 mg/ m2 blev sammenlignet med MabThera intravenøs 375 mg/m2 hos FL-patienter.
English: During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles), four patients (2 %) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Danish: I behandlingsperioden (induktionsbehandlingsfasen bestående af R-CHOP i højst 8 behandlingsserier) fik 4 patienter (2 %) i R-CHOP-armen, alle med kardiovaskulære risikofaktorer, tromboemboliske cerebrovaskulære hændelser under første behandlingsserie.
English: • The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.
Danish: • Øvrige indholdsstoffer: Natriumcitrat, polysorbat 80, natriumchlorid, natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: The complete response rate after cycle 8 was 76.2 % in the R-CHOP group and 62.4 % in the CHOP group (p=0.0028).
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: Kaplan-Meier estimated progression-free rates at 12 months were 78% in the MabThera maintenance group vs. 57 % in the observation group.
Danish: Kaplan-Meier estimeret sandsynlighed for progressionsfrihed ved 12 måneder var 78 % i MabThera vedligeholdelsesgruppen mod 57 % i observationsgruppen.
English: distribution volume, and elimination half-life were comparable for both formulations.
Danish: Farmakokinetiske parametre som clearance, fordelingsvolumen og halveringstid var sammenlignelige for de 2 formuleringer.
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (PML) and hepatitis C virus.
Danish: Nogle eksempler på disse alvorlige virusinfektioner er infektioner forårsaget af herpesvira (cytomegalovirus, varicella zoster virus og herpes simplex virus), JC virus (PML) og hepatitis C virus.
English: MabThera is a ready to use, clear to opalescent, colourless to yellowish liquid, supplied as a solution for subcutaneous injection in a colourless glass vial with a butyl rubber stopper with aluminium over seal and a blue plastic flip-off disk.
Danish: MabThera er en brugsklar, klar til opaliserende, farveløs til gullig opløsning, leveret som opløsning til subkutan injektion i et farveløst hætteglas med butylgummiprop med aluminiumsforsegling og blåt vipbart plastiklåg.
English: MabThera should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Danish: MabThera bør ikke administreres til patienter med en aktiv, alvorlig infektion (for eksempel tuberkulose, sepsis og opportunistiske infektioner, se pkt.
English: MabThera intravenous formulation was used at the standard dose of 375 mg/m2.
Danish: MabThera intravenøs formulering blev givet i standarddosen 375 mg/m2 legemsoverfladeareal.
English: Results from other supportive studies using MabThera in combination with other chemotherapy regimens (including CHOP, FCM, PC, PCM, bendamustine and cladribine) for the treatment of previously untreated and/or relapsed/refractory CLL patients have also demonstrated high overall response rates with benefit in terms of PFS rates, albeit with modestly higher toxicity (especially myelotoxicity).
Danish: Resultater fra andre støttende studier, som anvendte MabThera i kombination med andre kemoterapiregimer (herunder CHOP, FCM, PC og PCM, bendamustin og cladribin) til behandling af tidligere ubehandlede og/eller relaps/refraktære CLL-patienter, har også vist høje totale responsrater med fordele med hensyn til PFS-rater om end med moderat højere toksicitet (specielt myelotoksicitet).
English: Local cutaneous reactions, including injection site reactions were very common in patients receiving MabThera subcutaneous formulation.
Danish: Lokale hudreaktioner, inklusive lokale reaktioner ved injektionsstedet, var meget almindelige hos patienter behandlet med MabThera subkutan formulering.
English: • severe skin problems causing blisters that can be life-threatening
Danish: • svære hudproblemer med blister, der kan være livsfarlige
English: There was no evidence of clinically relevant dependencies of rituximab pharmacokinetics on age and sex.
Danish: Der var ingen tegn på, at alder og køn skulle påvirke farmakokinetik for rituximab i klinisk relevant grad.
English: • fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell
Danish: • fever, hoste, ondt i halsen, brændende smerte ved vandladning eller følelse af svaghed eller almen utilpashed
English: Patients randomised to the MabThera group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15.
Danish: De patienter, der blev randomiseret til MabThera-gruppen, fik en initial dosis på 1.000 mg intravenøst på studiedag 1 og endnu en dosis på 1.000 mg intravenøst på studiedag 15.
English: arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Danish: arytmier, +atrieflimren, takykardi, +hjertesygdom
English: R-CVP led to a significant benefit over CVP for the primary endpoint, time to treatment failure (27 months vs. 6.6 months, p < 0.0001, log-rank test).
Danish: R-CVP var signifikant bedre end CVP mht. det primære endepunkt, tid til behandlingssvigt (27 måneder versus 6,6 måneder), p < 0,0001, log rank test).
English: Table 3 Summary of key results from four phase III randomized trials evaluating the benefit of MabThera with different chemotherapy regimens in follicular lymphoma
Danish: Tabel 3 Sammenfatning af nøgleresultater fra 4 randomiserede fase III-studier, der evaluerer fordelene ved MabThera med forskellige kemoterapibehandlinger ved follikulært lymfom
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 100 mg / 10 mL
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 100 mg/10 ml
English: For CLL patients similar results are assumable considering similarities between both diseases, but this has not been investigated in clinical trials.
Danish: Det kan antages at lignende resultater vil ses hos patienter med kronisk lymfatisk leukæmi i betragtning af lighederne mellem begge sygdomme, men det har ikke været undersøgt i kliniske forsøg.
English: In a population pharmacokinetic analysis in 403 follicular lymphoma patients who received subcutaneous and/or intravenous MabThera, single or multiple infusions of MabThera as a single agent or in combination with chemotherapy, the population estimates of nonspecific clearance (CL1), initial specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.194 L/day, 0.535 L/day, and 4.37 L/day, respectively.
Danish: I en farmakokinetisk populationsanalyse af 403 patienter med follikulært lymfom behandlet med MabThera subkutant og/eller intravenøst, enkelt- eller gentagne infusioner af MabThera som enkeltstof eller i kombination med kemoterapi, var populationsestimater af ikke-specifik clearance (CL1), initial specifik clearance (CL2) - sandsynligvis skabt af B-celler eller tumorbyrde - og centralt kompartment fordelingsvolumen (V1), henholdsvis 0,194 l/dag, 0,535 l/dag og 4,37 l/dag.
English: Muscle spasms
Danish: Cyclophosphamid
English: The incidence of treatment-induced/enhanced anti-rHuPH20 antibodies, only measured in patients in the subcutaneous arm was 12%.
Danish: Forekomsten af behandlingsinducerede/forhøjede anti-rHuPH20-antistoffer var 12 % og var kun målt i den sukutane gruppe.
English: Significant difference from placebo + MTX at the primary timepoint: ***p ≤ 0.0001
Danish: † resultat ved uge 24 Signifikant forskel fra placebo + MTX ved det primære tidspunkt: ***p ≤ 0,0001
English: This is because MabThera can affect the way some other medicines work.
Danish: Det er vigtigt, da MabThera kan påvirke virkningen af anden medicin, og anden medicin kan påvirke virkningen af MabThera.
English: Kaplan-Meier estimated progression-free rates at 12 months were 78 % in the MabThera maintenance group vs. 57 % in the observation group.
Danish: Den Kaplan-Meier-estimerede progressionsfri rate ved 12 måneder var 78 % i MabTheravedligeholdelsesbehandlingsgruppen versus 57 % i observationsgruppen.
English: 6 Contents of the pack and other information
Danish: 6 Pakningsstørrelse og yderligere indhold
English: MabThera maintenance treatment reduced the risk of death by 56% (95% CI; 22%-75%).
Danish: MabThera vedligeholdelsesbehandling reducerede risikoen for død med 56 % (95 % konfidensinterval: 22 %-75 %).
English: Clear to opalescent, colourless to yellowish liquid.
Danish: Klar til uigennemsigtig, farveløs til gullig væske.
English: 95% CIb
Danish: 95% konfidensinterval
English: Safety and efficacy of MabThera have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Danish: Sikkerhed og effekt af MabThera er ikke påvist i kombination med andre kemoterapiregimer til behandling af diffust storcellet B-celle non-Hodgkin-lymfom.
English: Each 10 mL vial contains 2.3 mmol (52.6 mg) sodium.
Danish: Hvert 10 ml hætteglas indeholder 2,3 mmol (52,6 mg) natrium.
English: After this, you will be given MabThera as an injection under your skin (subcutaneous injection) over approximately 5 minutes.
Danish: Herefter gives MabThera som en indsprøjtning under huden (subkutan indsprøjtning) over ca. 5 minutter.
English: CI: Confidence Interval
Danish: Forskel (konfidensinterval
English: ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Danish: Den samlede responsrate var 57 % (95 % konfidensinterval: 41 % - 73 %; CR 14 % og PR 43 %) med en median tid indtil progression, for responderende patienter, på 19,4 måneder (interval: 5,3-38,9 måneder).
English: Clinical experience of MabThera concentrate for solution for infusion in Non-Hodgkin's lymphoma
Danish: Klinisk erfaring med MabThera koncentrat til opløsning til infusion ved non-Hodgkin-lymfom
English: In total: 8 cycles.
Danish: I alt 8 behandlingsserier.
English: MabThera has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Danish: Det er vist, at MabThera i kombination med methotrexat reducerer hastigheden af ledskadeprogression, målt ved hjælp af røntgen, samt forbedrer fysisk funktionsevne.
English: • Pain in the tummy, back, muscles and/or joints
Danish: • smerter i maven, ryg, muskler og/eller led
English: In case of such an event with a suspected relationship to MabThera, treatment should be permanently discontinued.
Danish: Hvis en sådan bivirkning skulle opstå med formodet relation til MabThera, skal behandlingen seponeres permanent.
English: In clinical trial BO22334, an effect was observed between body size and exposure ratios reported in cycle 7, between rituximab subcutaneous formulation 1400 mg q3w and rituximab intravenous formulation 375 mg/m2 q3w with Ctrough ratios of 2.29, 1.31, and 1.41 in patients with low, medium and high BSA, respectively (low BSA ≤ 1.70 m2; 1.70 m2 < medium BSA < 1.90 m2; high BSA
Danish: I det kliniske studie BO22334, blev effekt observeret imellem kropsstørrelse og eksponeringsratio i behandlingsserie 7, mellem rituximab subkutan formulering 1400 mg hver 3. uge og rituximab intravenøs formulering 375 mg/m2 hver 3. uge med Ctrough ratio på 2,29; 1,31 og 1,41 hos patienter med henholdsvis lavt, medium og højt legemsoverfladeareal (BSA) (lavt BSA ≤ 1,70 m2; 1,70 m2 <
English: Similar events were observed in the CLL SAWYER trial (BO25341) and were reported in up to 42% of patients in the MabThera subcutaneous arm.
Danish: Lignende bivirkninger blev set i SAWYER studiet (BO25341) hos patienter med kronisk lymfatisk leukæmi og rapporteret hos op til 42 % af de patienter, der fik subkutan MabThera.
English: The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the MabThera-arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
Danish: Følgende reaktioner blev indberettet som bivirkninger under de kliniske studier, men blev rapporteret med samme eller lavere hyppighed i MabThera-armen, sammenlignet med kontrolarmene: hæmatotoksicitet, infektioner hos neutropene patienter, urinvejsinfektioner, sensoriske forstyrrelser og pyreksi.
English: 1 vial of 50 mL
Danish: 1 hætteglas a 50 ml
English: Treatment with MabThera in combination with methotrexate over multiple courses resulted in sustained improvements in the clinical signs and symptoms of RA, as indicated by ACR, DAS28-ESR and EULAR responses which was evident in all patient populations studied (Figure 2).
Danish: Gentagne behandlingsserier med MabThera i kombination med methotrexat resulterede i vedvarende forbedringer af kliniske symptomer på RA angivet ved ACR- DAS28-ESR- og EULAR-respons.
English: After this, you will be given MabThera as an injection under your skin (subcutaneous injection) over approximately 7 minutes.
Danish: Herefter gives MabThera som en indsprøjtning under huden (subkutan indsprøjtning) over ca. 7 minutter.
English: In a prospective, open label, international, multi-centre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or MabThera plus CHOP (R-CHOP, n=234).
Danish: I et prospektivt, ublindet, internationalt, multicenter fase III-studie, blev 465 patienter med recidiveret/ refraktært follikulært lymfom i første omgang randomiseret til induktionsbehandling med enten CHOP (cyclophosphamid, doxorubicin, vincristin, prednisolon; n=231) eller MabThera plus CHOP (R-CHOP, n=234).
English: The hypodermic injection needle must only be attached to the syringe immediately prior to administration to avoid potential needle clogging.
Danish: For at undgå at nålen tilstoppes, skal den hypodermiske injektionsnål først sættes på sprøjten umiddelbart inden administration.
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of MabThera.
Danish: Der bør altid gives præmedicin bestående af et anti-pyretisk lægemiddel samt et antihistamin, f.eks. paracetamol og diphenhydramin, inden hver MabThera-administration.
English: MabThera 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: MabThera 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: Decreased haemoglobin Metabolism and nutrition disorders Hyperkalaemia
Danish: Nedsat hæmoglobin Metabolisme og ernæring Hyperkaliæmi
English: For information related to the autoimmune indications, please refer to the SmPC of MabThera intravenous formulation.
Danish: For information i forhold til autoimmune indikationer henvises til produktresuméet for MabThera intravenøs formulering.
English: MabThera maintenance treatment reduced the risk of death by 56 % (95 % CI; 22 %-75 %).
Danish: MabThera-vedligeholdelsesbehandling reducerede risiko for død med 56 % (95 % konfidensinterval; 22-75 %).
English: After a median observation time of 31 months for patients randomised to the induction phase, R-CHOP significantly improved the outcome of patients with relapsed/refractory follicular lymphoma when compared to CHOP (see Table 5).
Danish: Efter en median observationstid på 31 måneder for patienter randomiseret til induktionsfasen, forbedrede R-CHOP signifikant udfaldet af recidiveret/refraktært follikulært lymfom sammenlignet med CHOP (se Tabel 5).
English: Immunisation
Danish: Immungenicitet
English: In patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment.
Danish: Hvis behandlingen virker, kan MabThera gives som vedligeholdelsesbehandling i 2 år efter, den første behandling er givet.
English: Stage 1 enrolled previously untreated patients (n=127) CD20-positive, Follicular Lymphoma (FL) Grade 1, 2 or 3a.
Danish: I første stadie af studiet blev tidligere ubehandlede patienter med CD20-positivt, follikulært lymfom af grad 1, 2, eller 3a (n=127) inkluderet.
English: Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1x109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1x109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with MabThera plus FC.
Danish: Studier af tidligere ubehandlet og relaps/refraktær CLL har fastslået, at hos op til 25 % af patienterne behandlet med R-FC var neutropeni forlænget (defineret som neutrofiltal, der forblev under 1x109/l mellem dag 24 og 42 efter sidste dosis) eller indtraf sent (defineret som neutrofiltal under 1x109/l senere end dag 42 efter sidste dosis hos patienter uden tidligere forlænget neutropeni eller hos patienter, som restituerede før dag 42) efter behandling med MabThera plus FC.
English: MabThera intravenous formulation
Danish: MabThera intravenøs formulering
English: The MabThera intravenous formulation has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Danish: MabThera er i den intravenøse formulering anvendt til 21 patienter, som havde fået foretaget autolog knoglemarvstransplantation og til andre risikogrupper med formodet nedsat knoglemarvsfunktion uden at fremkalde myelotoksicitet.
English: Three patients in the MabThera subcutaneous formulation trial SABRINA (BO22334) were inadvertently administered subcutaneous formulation through the intravenous route up to a maximum rituximab dose of 2780 mg with no untoward effect.
Danish: Tre patienter i SABRINA-studiet (BO22334) med MabThera subkutan formulering fik utilsigtet administreret en subkutandosis op til et maksimum på 2.780 mg rituximab intravenøst uden bivirkninger.
English: A course of MabThera consists of two 1000 mg intravenous infusions.
Danish: En behandlingsserie med MabThera består af to intravenøse infusioner a 1.000 mg.
English: Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 4).
Danish: Signifikant fordel af vedligeholdelsesbehandling med MabThera blev også set for de sekundære effektmål; hændelsesfri overlevelse (EFS), tid til næste anti-lymfom-behandling (TNLT), tid til næste kemoterapibehandling (TNCT) og samlet responsrate (ORR) i den primære analyse (tabel 4).
English: MabThera 1400 mg can be given alone or with other medicines called “chemotherapy”.
Danish: MabThera 1400 mg kan anvendes alene eller sammen med kemoterapi.
English: Three patients in the MabThera subcutaneous NHL formulation trial SABRINA (BO22334) were inadvertently adminstered subcutaneous formulation through the intravenous route up to a maximum rituximab dose of 2780 mg with no untoward effect.
Danish: Tre patienter i SABRINA-studiet (BO22334) med MabThera subkutan NHL formulering fik utilsigtet administreret en subkutandosis op til et maksimum på 2.780 mg rituximab intravenøst uden bivirkninger.
English: The objective of the Part 1 was to select a MabThera subcutaneous formulation dose that resulted in comparable MabThera serum Ctrough levels compared with MabThera intravenous formulation.
Danish: Formålet med det første del var at bestemme den subkutane dosis af MabThera, som gav serum Ctroughniveauer, der var sammenlignelige med den intravenøse formulering af MabThera.