FrancophonIA/ELRC3.0 huggingface dataset:
English: Occurred at various times up to several months after completion of MabThera therapy 6 observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly associated with infusion-related reactions 7 includes fatal cases
Danish: Forekom på forskellige tidspunkter op til flere måneder efter afslutningen af behandlingen med MabThera 6 Fortrinsvis set hos patienter med tidligere hjertesygdom og/eller kardiotoksisk kemoterapi.
English: Event-free survival (median)
Danish: Hændelsesfri overlevelse (median)
English: The benefit in terms of PFS was observed in almost all patient subgroups analysed according to disease risk at baseline.
Danish: I forhold til sygdomsrisikoen ved baseline blev der observeret en fordel med hensyn til PFS i næsten alle patientundergrupper, som blev analyseret.
English: Infusion related adverse reactions of all kinds have been observed in 77% of patients treated with MabThera intravenous formulation (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10 % of patients) see section 4.8.
Danish: Der er set infusionsrelaterede bivirkninger, i en eller anden form, hos 77 % af patienterne behandlet med MabThera intravenøs formulering (herunder er cytokinfrigivelsessyndrom ledsaget af hypotension og bronkospasme set hos 10 % af patienterne) se pkt.
English: • MabThera intravenous formulation (n= 205): 8 cycles of MabThera intravenous formulation in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks.
Danish: • MabThera intravenous formulering (n= 205): 8 behandlingsserier med MabThera intravenøs formulering i kombination med op til 8 behandlingsserier CHOP- eller CVP-kemoterapi administreret hver 3. uge.
English: Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Danish: Da der er begrænset viden om brug af MabThera til børn og unge, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden medicinen gives, hvis du eller dit barn er under 18 år.
English: There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6% vs. 15.4%).
Danish: Patienter med udbredt sygdom havde en højere hyppighed af grad 3 og 4 bivirkninger end patienter uden udbredt sygdom (25,6 % versus 15,4 %).
English: The recommended dosage of MabThera 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 MabThera 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: Sodium MabThera 1600 mg contains less than 1 mmol sodium per dose, i.e. it is essentially sodium-free.
Danish: MabThera 1600 mg indeholder mindre end 1 mmol natrium pr. dosis, dvs. det er i det væsentlige natriumfri.
English: Studies with MabThera intravenous formulation 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.There were no differences reported for the incidence of anaemia.
Danish: Studier med MabThera intravenøs formulering hos 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: Duration of response* Disease free survival (DFS)** Time to new treatment
Danish: Responsvarighed* Sygdomsfri overlevelse (DFS)**
English: MabThera is administered on day 1 of each chemotherapy cycle after intravenous infusion of the glucocorticoid component of CHOP.
Danish: MabThera gives på dag 1 i hver kemoterapiserie, efter intravenøs infusion af glukokortikoidkomponenten i CHOP.
English: The chemotherapy should be given after the MabThera infusion.
Danish: Kemoterapien skal gives efter infusionen med MabThera.
English: Sodium MabThera 1400 mg contains less than 1 mmol sodium per dose, i.e. it is essentially sodium-free.
Danish: MabThera 1400 mg indeholder mindre end 1 mmol natrium pr. dosis, dvs. det er i det væsentlige natriumfri.
English: For storage conditions after first opening see section 6.3.
Danish: Opbevaringsforhold efter første åbning af lægemidlet, se pkt.
English: In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of MabThera.
Danish: Desuden påvirkede fludarabin og cyclophosphamid tilsyneladende ikke farmakokinetikken af MabThera.
English: Table 8 Induction phase: overview of efficacy results for CHOP vs. R-CHOP (31 months median observation time) CHOP R-CHOP p-value Risk Reduction1)
Danish: Tabel 8 Induktionsfase: Oversigt over effektdata for CHOP versus R-CHOP (31 måneders median observationstid)
English: MabThera subcutaneous formulation MabThera intravenous formulation
Danish: MabThera subkutan formulering MabThera intravenøs formulering
English: Table 8: Distribution/Elimination - Pharmacokinetic parameters of MabThera subcutaneous compared to MabThera intravenous Trial BP22333 (SparkThera) Geometric mean Ctrough
Danish: Tabel 8 Fordeling/elimination - Farmakokinetiske parametre for MabThera subkutan sammenlignet med MabThera intravenøs
English: Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with MabThera.
Danish: Der er observeret hypogammaglobulinæmi (IgA, IgG eller IgM under den nedre normalgrænse) hos patienter med GPA eller MPA behandlet med MabThera.
English: Hazard ratio (95% CI)
Danish: Hazard ratio (95% konfidensinterval)
English: All patients treated with MabThera 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 MabThera for reumatoid artrit, GPA, MPA eller PV skal have udleveret patientkortet ved hver infusion.
English: Keep the container in the outer carton, in order to protect from light
Danish: Opbevar hætteglasset i den ydre karton for at beskytte mod lys
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 MabThera.
Danish: Lægemidler til behandling af overfølsomhedsreaktioner, fx epinefrin (adrenalin), antihistaminer og glukokortikoider bør være umiddelbart tilgængelige i tilfælde af en allergisk reaktion under administration af MabThera.
English: For retreatment with MabThera monotherapy for patients who have responded to previous treatment with MabThera monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks
Danish: Til genbehandling med MabThera monoterapi til patienter, som har responderet på tidligere behandling med MabThera monoterapi for recidiveret/refraktært follikulært lymfom, er den anbefalede dosis: 375 mg/m2 legemsoverfladeareal, givet som en intravenøs infusion én gang ugentligt i 4 uger (se pkt.
English: Musculo skeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Danish: Knogler, led, muskler og bindevæv artralgier / muskuloskeletale smerter, osteoartrit, bursitis
English: Keep the vial in the outer carton, in order to protect from light.
Danish: Opbevares i den ydre karton for at beskytte mod lys.
English: c) If you are being treated for rheumatoid arthritis Each course of treatment is made up of two separate infusions which are given 2 weeks apart.
Danish: Hvert behandlingsforløb består af to separate infusioner, der gives med 2 ugers mellemrum.
English: The serum rituximab Cmax at cycle 7 was similar between the two treatment arms, with geometric mean (CV%) values of 250.63 (19.01) μg/mL and 236.82 (29.41) μg/mL for the intravenous and the subcutaneous formulations respectively, with the resulting geometric mean ratio (Cmax, SC/Cmax, IV) of 0.941 (90% CI: 0.872, 1.015).
Danish: Serum-rituximab Cmax ved behandlingsserie 7 var ens i de 2 behandlingsarme, med geometriske gennemsnitsværdier (CV%) på 250,63 (19,01) μg/ml og 236,82 (29,41) μg/ml for henholdsvis den intravenøse og den subkutane formulering, medførende et geometrisk gennemsnitsratio (Cmax, SC/Cmax, i.v.)
English: The ORR was 36 % (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
Danish: konfidensinterval: 21 % - 51 %; CR 3 % og PR 33 % med en median tid indtil progression, for responderende patienter, på 9,6 måneder (interval: 4,5- 26,8 måneder).
English: • MabThera intravenous (n= 88); 1st cycle of MabThera intravenous 375 mg/m2 in combination with chemotherapy followed by up to 5 cycles of MabThera intravenous 500 mg/m2 in combination with chemotherapy.
Danish: • MabThera intravenøs (n = 88): 1. serie af MabThera indgivet intravenøs 375 mg/m2 i kombination med kemoterapi efterfulgt af op til 5 serier af MabThera indgivet intravenøst 500 mg/m2 i kombination med kemoterapi.
English: The recommended dose is: first cycle, MabThera intravenous formulation: 375 mg/m2 body surface area, followed by subsequent cycles with MabThera subcutaneous formulation injected at a fixed dose of 1400 mg per cycle.
Danish: Anbefalet dosis er: første behandlingsserie med MabThera intravenøs formulering 375 mg/m2 legemsoverfladeareal; ved efterfølgende behandlingsserier gives MabThera subkutan formulering som injektion i fast dosis på 1400 mg per behandlingsserie.
English: The final analysis confirmed that R-CHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p = 0.0001).
Danish: Den endelige analyse bekræftede, at R-CHOP behandlingen var forbundet med klinisk relevant og statistisk signifikant forbedring af længden af den progressionsfrie overlevelse (de primære effektparametre var død, relaps, forværring af lymfomet eller påbegyndelse af ny antilymfombehandling) (p=0,0001).
English: Results from three other randomized trials using MabThera in combination with chemotherapy regimen other than CVP (CHOP, MCP, CHVP/Interferon-α) have also demonstrated significant improvements in response rates, time-dependent parameters as well as in overall survival.
Danish: Resultaterne fra tre andre randomiserede studier, hvor MabThera blev anvendt i kombination med andre kemoterapibehandlinger end CVP (CHOP, MCP, CHVP/Interferon-α), har også vist signifikante forbedringer i responsrater, tidsafhængige parametre samt samlet overlevelse.
English: In a prospective, open label, international, multi-centre, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
Danish: I et prospektivt, ublindet, internationalt, fase III-multicenter-studie fik 1193 patienter med tidligere ubehandlet, fremskredent follikulært lymfom induktionsbehandling med R-CHOP (n=881), R-CVP (n=268) eller R-FCM (n=44) efter investigators valg.
English: In CLL patients, co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Danish: Hos CLL-patienter synes samtidig administration af MabThera ikke at påvirke farmakokinetikken af fludarabin eller cyclophosphamid.
English: The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with MabThera, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following MabThera therapy.
Danish: Tilgængelige data indikerer, at hyppigheden af kliniske relevante infektioner er uændret, når disse terapier anvendes hos patienter, som tidligere er blevet behandlet med MabThera.
English: What MabThera contains
Danish: MabThera indeholder:
English: They were characterized by pulmonary events and in some cases included rapid tumour lysis and features of tumour lysis syndrome in addition to fever, chills, rigors, hypotension, urticaria, angioedema and other symptoms (see section 4.8).
Danish: Reaktionerne var karakteriseret ved pulmonale hændelser og omfattede i nogle tilfælde hurtig tumorlyse og tegn på tumorlysesyndrom foruden feber, kulderystelser, rigor, hypotension, urticaria, angioødem og andre symptomer (se pkt.
English: • MabThera subcutaneous formulation (n= 205): first cycle MabThera intravenous formulation plus 7 cycles of MabThera subcutaneous formulation in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks.
Danish: • MabThera subkutan formulering (n= 205): første behandlingsserie MabThera intravenøs formulering plus 7 behandlingsserier med MabThera subkutan formulering i kombination med op til 8 behandlingsserier CHOP- eller CVP-kemoterapi administreret hver 3. uge.
English: Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumour lysis syndrome.
Danish: Andre symptomer omfattede hedeture, angioødem, bronkospasmer, opkastning, kvalme, urticaria/udslæt, træthed, hovedpine, halsirritation, rhinitis, pruritus, smerter, takykardi, hypertension, hypotension, dyspnø, dyspepsi, asteni og tegn på tumorlysesyndrom.
English: Peripheral blood B cell counts begin to increase from week 24 and evidence for repopulation is observed in the majority of patients by week 40, whether MabThera was administered as monotherapy or in combination with methotrexate.
Danish: Tegn på gendannelse af B-celler blev observeret hos størstedelen af patienterne ved uge 40, uanset om MabThera blev anvendt som monoterapi eller i kombination med methotrexat.
English: MabThera subcutaneous formulation
Danish: MabThera subkutan formulering
English: Each 50 mL vial contains 500 mg of rituximab.
Danish: Hvert 50 ml hætteglas indeholder 500 mg rituximab.
English: Rituximab intravenous formulation (n = 205)
Danish: Rituximab intravenøs formulering (n = 205)
English: Since hypotension may occur during MabThera administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to giving MabThera.
Danish: Da der kan opstå hypotension under administration af MabThera, bør det overvejes at stoppe antihypertensiv behandling 12 timer inden, der gives MabThera.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Vial of 50 mL (10 mg/mL)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Hætteglas a 50 ml (10 mg/ml)
English: The reactions reported were usually reversible with a reduction in rate, or interruption, of MabThera infusion and administration of an anti-pyretic, an antihistamine, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Danish: De rapporterede reaktioner var som regel reversible efter reduktion af hastigheden eller afbrydelse af MabThera-infusionen og administration af et antipyretikum, et antihistamin og lejlighedsvis oxygen, intravenøs saltvandsopløsning eller bronkodilatorer samt glukokortikoider, hvis det var påkrævet.
English: • being sick (vomiting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion
Danish: • opkastning, diarré, mavesmerter, irritation eller sår i svælg eller mund, synkebesvær, forstoppelse, fordøjelsesproblemer
English: Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of MabThera as a single agent or in combination with CHOP therapy (applied MabThera doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Danish: Baseret på en populationsfarmakokinetisk undersøgelse af 298 patienter med NHL, som fik enkelte eller flere infusioner af MabThera alene eller i kombination med CHOP-kemoterapi (anvendte MabTheradoser varierede fra 100 til 500 mg/m2), vurderedes den non-specifikke clearance (CL1), den specifikke clearance (CL2), hvor B-celler eller tumor sandsynligvis bidrager, og det centrale kompartments distributionsvolumen til (V1) til at være henholdsvis 0,14 l/dag, 0,59 l/dag og 2,7 l. Den estimerede mediane terminale eliminationshalveringstid af MabThera var 22 dage (spændvidde 6, 152 dage).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 2 June 1998
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Tell your doctor immediately if you get signs of an infection including:
Danish: Kontakt straks lægen, hvis du får tegn på infektion, fx:
English: Metabolism and nutrition disorders hyperglycaemia, weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Danish: Metabolisme og ernæring hyperglykæmi, vægttab, perifert ødem, ansigtsødem, øget LD, hypocalcæmi
English: Initial treatment, bulky disease, weekly for 4 doses In pooled data from three trials, 39 patients with relapsed or chemoresistant, bulky disease (single lesion ≥ 10 cm in diameter), low grade or follicular B cell NHL received 375 mg/m2 of MabThera as intravenous infusion weekly for four doses.
Danish: Induktionsbehandling, udbredt sygdom, 1 dosis ugentligt til i alt 4 doser I data sammenlagt fra tre studier fik 39 patienter med recidiveret eller kemoterapi-resistent, udbredt sygdom (enkeltlæsion ≥ 10 cm i diameter), lavmalignt eller follikulært B-celle NHL 375 mg/m2
English: body surface area, followed by subsequent cycles with MabThera subcutaneous formulation injected at a fixed dose of 1400 mg per cycle for up to 8cycles.
Danish: legemsoverfladeareal; ved efterfølgende behandlingsserier gives MabThera subkutan formulering som injektion i fast dosis på 1400 mg per behandlingsserie i op til 8 behandlingsserier.
English: Since hypotension may occur during MabThera infusion, consideration should be given to withholding anti-hypertensive medications 12 hours prior to the MabThera infusion.
Danish: Da hypotension kan forekomme under infusion med MabThera, bør det overvejes at seponere antihypertensiva i 12 timer før MabThera-infusionen.
English: Re-treatment:
Danish: Vedligeholdelsesbehandling:
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 10 mg/mL rituximab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 10 mg/ml rituximab.
English: Following second infusion, mean Cmax ranged from 183 to 198 µg/mL for the 2 × 500 mg dose and ranged from 355 to 404 µg/mL for the 2 × 1000 mg dose.
Danish: Efter den anden infusion varierede gennemsnittet for Cmax fra 183 til 198 µg/ml for doseringen på 2 x 500 mg og fra 355 til 404 µg/ml for doseringen på 2 x 1.000 mg.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Vial of 10 mL (10 mg/mL)
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Hætteglas a 10 ml (10 mg/ml)
English: Rituximab intravenous formulation (n = 88)
Danish: Rituximab intravenøs formulering (n = 88)
English: The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 1400 mg once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 administrations in total).
Danish: Den anbefalede dosis af MabThera subkutan formulering til vedligeholdelsesbehandling hos tidligere ubehandlede patienter med follikulært lymfom, som har responderet på induktionsbehandling, er 1400 mg én gang hver 2. måned (startende 2 måneder efter sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (administreres i alt 12 gange).
English: • lower immunity - because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection.
Danish: • lavt immunforsvar, fordi indholdet af antistoffer i blodet, som beskytter mod infektion, kaldet immunglobuliner (IgG), falder.
English: The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 1400 mg once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 administrations in total).
Danish: Den anbefalede dosis af MabThera subkutan formulering til vedligeholdelsesbehandling hos patienter med recidiveret/refraktært follikulært lymfom, som har responderet på induktionsbehandling, er 1400 mg én gang hver 3. måned (startende 3 måneder efter sidste dosis i induktionsbehandlingen) indtil sygdomsprogression eller i maksimalt 2 år (administreres i alt 8 gange).
English: The safety of immunisation with live viral vaccines, following MabThera therapy has not been studied for NHL patients and vaccination with live virus vaccines is not recommended.
Danish: Sikkerhed ved vaccination med levende, virale vacciner efter MabThera-behandling er ikke undersøgt hos NHL-patienter, og vaccination med levende, virale vacciner frarådes.
English: Similarly, the geometric mean AUC (CV%) values at Cycle 6 were higher among the subcutaneous group than the intravenous group; 4088 µg•day/mL (34.2) versus 3630 µg•day/mL (32.8) respectively) with a resulting adjusted geometric mean ratio [90% CI] of 1.10 [0.98-1.24].
Danish: Ligeledes var værdier for det geometriske gennemsnits AUC (CV %) ved behandlingsserie 6 højere i den subkutane gruppe end i den intravenøse gruppe, henholdsvis 4088 μg∙dag/ml (34,2) versus 3630 μg∙dag/ml (32,8).
English: Corticosteroids will usually be given by injection before the start of MabThera treatment.
Danish: Du vil som regel få en indsprøjtning med binyrebarkhormon, inden behandlingen med MabThera påbegyndes.
English: These events were Grade 3 injection site rash and dry mouth.
Danish: Disse bivirkninger var grad 3 udslæt ved injektionsstedet og mundtørhed.
English: The estimated median terminal elimination half-life of MabThera was 22 days (range, 6.1 to 52 days).
Danish: Den estimerede median for halveringstid for MabThera subkutan formulering var 29,7 dage (9,9 til 91,2 dage).
English: The prepared infusion solution of MabThera in 5% D-glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C plus an additional 12 hours at room temperature.
Danish: • Efter aseptisk fortynding i D-glukose opløsning Den tilberedte MabThera infusionsopløsning er i 5 % D-glukose opløsning fysisk og kemisk stabil i 24 timer ved 2 °C - 8 °C og efterfølgende i yderligere 12 timer ved stuetemperatur.
English: Cases of fatal PML that occurred after disease progression and retreatment have also been reported in clinical trials.
Danish: Også i kliniske studier er der rapporteret tilfælde af fatal PML, som forekom efter sygdomsprogression og genbehandling.