natgillin/translations-raw huggingface dataset:
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)
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)
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).
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).
Neutrofiltælling bør foretages inden hver MabThera behandlingsserie og regelmæssigt op til 6 måneder efter afsluttet behandling, samt ved tegn på infektion (se pkt.
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).
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/
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).
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).
Alvorlige infektioner, inklusive fatale tilfælde, kan forekomme under behandlingsforløbet med MabThera (se pkt.
Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
MabThera indeholder natrium
MabThera contains sodium
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.
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.
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.
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.
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.
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.
I de fleste tilfælde blev MabThera givet sammen med kemoterapi.
In the majority of these cases, MabThera was administered with chemotherapy.
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.
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.
• Kronisk lymfatisk leukæmi er den mest almindelige form for leukæmi hos voksne.
• Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
• Kardiovaskulære sygdomme, se pkt 4.4.
• Cardiovascular events, see section 4.4.
B-celle niveauet normaliseredes hos disse dyr indenfor 6 måneder efter fødslen og påvirkede ikke vaccinationsreaktionen.
B cell counts returned to normal in these animals within 6 months of birth and did not compromise the reaction to immunization.
FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
L-histidin hydrochloridmonohydrat α,α-trehalosedihydrat
L-histidine hydrochloride monohydrate α,α-trehalose dihydrate L-methionine
Antallet af patienter uden kortikosteroid-behandling eller behandlet med minimalt kortikosteroid (≤ 10mg/dag) over tid
Figure 4: Number of patients who were off or on minimal corticosteroid (≤10mg/day) therapy over time
Dog kan respons efter vaccination med ikke-levende vacciner være nedsat.
However with non-live vaccines response rates may be reduced.
Når MabThera gives i kombination med kemoterapi, bør standard dosisreduktioner for de kemoterapeutiske lægemidler anvendes (se pkt.
When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied (see section 4.8).
Den kliniske relevans af udviklingen af anti-rituximab eller anti-rHuPH20-antistoffer efter behandling med MabThera subkutan formulering er ukendt.
The clinical relevance of the development of anti-rituximab or anti-rHuPH20 antibodies after treatment with MabThera subcutaneous formulation is not known.
Den anbefalede dosis af MabThera er 1.000 mg ved intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion to uger senere.
The recommended dosage of MabThera is 1000 mg by intravenous infusion followed by a second 1000 mg intravenous infusion two weeks later.
Hyppigheden af trombocytopeni var lav (< 1, grad 3/4), og der var ingen forskel mellem behandlingsarmene.
The incidence of thrombocytopenia was low (<1 %, grade 3/4) and was not different between treatment arms.
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.
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).
De mest almindelige infektioner i MabThera-armen inkluderede øvre luftvejsinfektioner, gastroenteritis, urinvejsinfektioner og herpes zoster.
The most common infections in the MabThera arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster.
Sikkerhedsprofilen for MabThera hos patienter med PV var sammenlignelig med den observeret hos patienter med reumatoid artrit og GPA/MPA.
The safety profile of MabThera in patients with PV was consistent with that observed in RA and GPA/MPA patients.
De mest almindelige infektioner i MabThera-gruppen var herpes simplex og zoster infektioner, bronkitis, urinvejsinfektion, svampeinfektion og konjunktivitis.
The most common infections in the MabThera group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
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.
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.
Der er ikke gennemført specifikke studier til at fastlægge rituximab eller rHuPH20s effekt på fertiliteten.
Specific studies to determine the effects of rituximab or rHuPH20 on fertility have not been performed.
De fleste bivirkninger i MabThera-armen var lette til moderate i intensitet.
Most adverse events in the MabThera arm were mild or moderate in intensity.
I fase III-studiet SABRINA (BO22334) blev lokale hudreaktioner rapporteret hos op til 20 % af de patienter, der fik subkutan MabThera.
In the phase 3 SABRINA trial (BO22334), local cutaneous reaction were reported in up to 20% of patients receiving subcutaneous MabThera.
Rituximaboptagelse øges dosisproportionalt over dosisspændet 375 mg/m2 til 800 mg/m2 subkutant.
Rituximab exposure increased dose proportional over the 375 mg/m2 to 800 mg/m2 subcutaneous dose range.
Ca. 2.400 patienter fik to eller flere behandlingsserier, heraf fik over 1.000 patienter fem eller flere behandlingsserier.
In clinical trials more than 3100 patients received at least one treatment course and were followed for periods ranging from 6 months to over 5 years; approximately 2400 patients received two or more courses of treatment with over 1000 having received 5 or more courses.
Effekt og sikkerhed af MabThera i kombination med kortvarig lavdosis glukokortikoid (prednison) behandling blev evalueret hos nyligt diagnosticerede patienter med moderat til svær pemfigus (74 patienter med pemfigus vulgaris (PV) og 16 med pemfigus foliaceus (PF)) i et randomiseret, åbent, kontrolleret, multicenterstudie.
The efficacy and safety of MabThera in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study.
MabThera er blevet anvendt til 21 patienter, som havde fået foretaget autolog knoglemarvstransplantation, og til andre risikogrupper med formodet nedsat knoglemarvsfunktion uden at fremkalde myelotoksicitet.
MabThera 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.
Under vedligeholdelsesbehandling var incidensen af grad 3/4 kardielle forstyrrelser sammenlignelig mellem patienter behandlet med MabThera og patienter under observation.
During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with MabThera and observation.
I CLL 1. linjestudiet oplevede Binet stadie C patienter i R-FC-armen flere bivirkninger sammenlignet med patienter i FC-armen (R-FC 83 % versus FC 71 %).
In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC 71%).
Hvis du behandles for kronisk lymfatisk leukæmi Hvis du behandles med MabThera i kombination med kemoterapi, vil du få en infusion med MabThera på dag 0 i serie 1 og derefter på dag 1 i hver af i alt 6 serier.
b) If you are being treated for chronic lymphocytic leukaemia When you are treated with MabThera in combination with chemotherapy, you will receive MabThera infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
MabThera gives altid i et drop (intravenøs infusion).
You will always be given MabThera as a drip (intra-venous infusion).
Den kliniske relevans af udviklingen af anti-rituximab-antistoffer eller anti-rHuPH20-antistoffer efter behandling med MabThera subkutan formulering er ukendt.
The clinical relevance of the development of anti-rituximab antibodies or anti-rHuPH20 antibodies after treatment with MabThera subcutaneous formulation is not known.
Hud og subkutane væv alopeci
Skin and subcutaneous tissue disorders alopecia
Tabel 4 Oversigt over effektdata for MabThera vedligeholdelsesbehandling versus observation ved den protokol definerede primær analyse og efter 9 års median opfølgningstid (final analyse)
Table 4 Overview of efficacy results for MabThera maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
I alt 197 patienter i alderen 15 år og derover med svær, aktiv GPA (75%) eller MPA (24%) blev inkluderet og behandlet i et randomiseret, dobbeltblindet, placebokontrolleret, non-inferioritetsmulticenterstudie med aktiv kontrolgruppe.
A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
I kliniske studier med MabThera som vedligeholdelsesbehandling af recidiveret/ refraktært follikulært lymfom var de mediane IgG-niveauer under nedre referencegrænse (< 7 g/l) i både observationsgruppen og MabThera-gruppen efter induktionsbehandlingen.
In the clinical trial evaluating MabThera maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the MabThera groups.
Tid indtil ny CLL-behandling
Time to new lymphoma treatment
Størstedelen af patienterne (81 %) viste tegn på B-celleregenerering med >10 celler/mikroliter ved måned 12; dette steg til 87% af patienterne ved måned 18.
with counts >10 cells/μL by month 12, increasing to 87% of patients by month 18.
Patienter med stor tumorbyrde eller med et højt antal (≥ 25 x 109/l) cirkulerende maligne celler, som f.eks. patienter med CLL, som kan have øget risiko for især svært cytokinfrigivelsessyndrom, bør behandles med yderste forsigtighed.
Patients with a high tumour burden or with a high number (≥25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution.
I skal fortsætte med sikker prævention i 12 måneder efter din sidste behandling med MabThera.
You must also do this for 12 months after your last treatment with MabThera.
MabThera 1600 mg subkutan formulering må udelukkende administreres som subkutan injektion over ca. 7 minutter.
MabThera 1600 mg subcutaneous formulation should be administered as subcutaneous injection only, over approximately 7 minutes.
I alt blev 810 patienter (403 R-FC, 407 FC) i 1. linje-studiet (tabel 2a og tabel 2b) og 552 patienter (276 R-FC, 276 FC) i relaps/refraktær studiet (tabel 3) analyseret for effekt.
A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 2a and Table 2b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 3) were analysed for efficacy.
Hvis du er i tvivl, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden du får MabThera.
If you are not sure, talk to your doctor, pharmacist or nurse before you are given MabThera.
Hos patienter med GPA eller MPA anbefales det at give methylprednisolon intravenøst i 1-3 dage i en dosis på 1000 mg pr. dag inden den første MabThera-infusion (sidste dosis methylprednisolon kan gives samme dag som første MabThera-infusion).
In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of MabThera (the last dose of methylprednisolone may be given on the same day as the first infusion of MabThera).
• allergiske reaktioner herunder hvæsende vejrtrækning og åndenød, hævelse af ansigt og tunge, kollaps
• Allergic reactions including wheezing or shortness of breath, swelling of the face and tongue,
Fertilitet Dyrestudier har ikke afsløret, at rituximab skulle have skadelig effekt på reproduktionsorganer.
Animal studies did not reveal deleterious effects of rituximab on reproductive organs.
Angina pectoris, hjertearytmier såsom atrieflimren og atrieflagren, hjerteinsufficiens og/eller myokardieinfarkt er forekommet hos patienter behandlet med MabThera.
Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with MabThera.
Patienter, der blev randomiseret til MabThera-gruppen, fik en initial intravenøs infusion på 1.000 mg MabThera på studiedag 1 i kombination med 0,5 mg/kg/dag oral prednison nedtitreret over 3 måneder, hvis de havde moderat sygdom, eller 1 mg/kg/dag oral prednison nedtitreret over 6 måneder, hvis de havde svær sygdom, og fik endnu en intravenøs infusion på 1.000 mg på studiedag 15.
Patients randomised to the MabThera group received an initial intravenous infusion of 1000 mg MabThera on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15.
Klinisk erfaring med MabThera subkutan formulering til non-Hodgkin-lymfom Klinisk erfaring med MabThera subkutan formulering til non-Hodgkin-lymfom er baseret på data fra et fase III-klinisk studie (SABRINA BO22334) med patienter med follikulært lymfom (FL) og et fase Ib-dosisfastsættelses-/dosisbekræftende studie (SparkThera BP22333) med patienter med FL.
The clinical experience of MabThera subcutaneous formulation in Non-Hodgkin's lymphoma is based on data from a phase III clinical trial (SABRINA BO22334) in patients with follicular lymphoma (FL) and a phase Ib dose-finding/dose-confirmation trial (SparkThera BP22333) in patients with FL.
Tabel 7 Oversigt over effektdata for MabThera vedligeholdelsesbehandling versus observation ved den protokol definerede primær analyse og efter 9 års median opfølgningstid (final analyse)
Table 7 Overview of efficacy results for MabThera maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Der blev rapporteret om nogle tilfælde af sen neutropeni, som indtraf mere end fire uger efter den sidste MabThera-infusion.
Some cases of late neutropenia occurring more than four weeks after the last infusion of MabThera were reported.
• Efter aseptisk fortynding i natriumchlorid opløsning Den tilberedte MabThera infusionsopløsning er i 0,9 % natriumchlorid opløsning fysisk og kemisk stabil i 30 dage ved 2 °C - 8 °C og efterfølgende i yderligere 24 timer ved temperatur ≤ 30 °C.
• After aseptic dilution in sodium chloride solution The prepared infusion solution of MabThera in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2 °C - 8 °C plus an additional 24 hours at ≤ 30 °C.
MabThera 1400 mg subkutan formulering må udelukkende administreres som subkutan injektion over ca. 5 minutter.
MabThera 1400 mg subcutaneous formulation should be administered as subcutaneous injection only, over approximately 5 minutes.
I de kliniske studier med MabThera monoterapi givet i 4 uger forekom hæmatologiske bivirkninger hos en minoritet af patienterne og var sædvanligvis lette og reversible.
In clinical trials with MabThera monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
MabThera 1600 mg anvendes til behandling af kronisk lymfatisk leukæmi hos voksne.
MabThera 1600 mg is used to treat chronic lymphocytic leukaemia -in adults.
Efter to intravenøse infusioner af MabThera i en dosis på 1.000 mg med to ugers interval, var den gennemsnitlige halveringstid 20,8 dage (i intervallet 8,58 dage til 35,9 dage), den gennemsnitlige systemiske clearance var 0,23 l/dag (i intervallet 0,091 til 0,67 l/dag) og det gennemsnitlige steadystate fordelingsvolumen var 4,6 l (i intervallet 1,7 til 7,51 l).
Following two intravenous infusions of MabThera at a dose of 1000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 l (range, 1.7 to 7.51 L).
MabThera fås som medicin, der gives i drop (MabThera 100 mg eller 500 mg koncentrat til opløsning til infusion) og som medicin, der gives som indsprøjtning under huden (MabThera 1400 mg eller MabThera 1600 mg, opløsning til subkutan injektion).
MabThera is available as a medicine given as a drip (called MabThera 100 mg or MabThera 500 mg, concentrate for solution for infusion) and as a medicine for injection under your skin (called MabThera 1400 mg or MabThera 1600 mg, solution for subcutaneous injection).
Patienten bør overvåges i mindst 15 minutter efter en subkutan injektion med MabThera.
Patients should be observed for at least 15 minutes following MabThera subcutaneous administration.
Sikkerhedsprofilen for MabThera i kombination med kortvarig lavdosis glukokortikoider til behandling af patienter med PV blev undersøgt i et randomiseret, kontrolleret, åbent, multicenter fase III-studie, der inkluderede 38 patienter med PV randomiseret til MabThera-gruppen.
The safety profile of MabThera in combination with short-term, low-dose glucocorticoids in the treatment of patients with pemphigus vulgaris was studied in a Phase 3, randomised, controlled, multicenter, open-label study in pemphigus patients that included 38 pemphigus vulgaris (PV) patients randomised to the MabThera group.
Populationer med reumatoid artrit, som ikke tidligere har været behandlet med methotrexat (MTX) Anvendelse af MabThera hos patienter, som ikke tidligere har været behandlet med MTX, anbefales ikke, da et favorabelt risk/benefit-forhold ikke er blevet fastlagt.
Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of MabThera is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Den farmakokinetiske profil af MabThera, når det blev givet som 6 infusioner af 375 mg/m2 i kombination med 6 serier af CHOP kemoterapi, var sammenlignelig med den for MabThera indgivet som monoterapibehandling.
The pharmacokinetic profile of MabThera when administered as 6 infusions of 375 mg/m2 in combination with 6 cycles of CHOP chemotherapy was similar to that seen with MabThera alone.
Andelen af patienter med tumorrespons (CR, Cru, PR) var signifikant højere (p < 0,0001 chi square test) i R-CVP-gruppen (80,9 %) end i CVP-gruppen (57,2 %).
The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p< 0.0001 Chi-Square test) in the R-CVP group (80.9 %) than the CVP group (57.2 %).
Informationen til lægen om MabThera skal indeholde følgende nøgle-elementer:
The Physician information about MabThera should contain the following key elements:
Under kliniske studier har infektioner i de nedre luftveje (inklusive pneumoni) været rapporteret med en forekomst i MabThera-armene svarende til forekomsten i kontrolarmene.
Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the MabThera arms compared to control arms.
Kardiovaskulære sygdomme, se pkt 4.4.
• Cardiovascular disorders, see section 4.4.
Der er rapporteret om tilfælde af reaktivering af hepatitis B, hvoraf de fleste forekom hos patienter, som fik MabThera i kombination med cytotoksisk kemoterapi.
Cases of hepatitis B reactivation, have been reported, the majority of which were in patients receiving MabThera in combination with cytotoxic chemotherapy.
I alt 1078 patienter responderede på induktionsbehandling, hvoraf 1018 blev randomiseret til MabThera vedligeholdelsesbehandling (n = 505) eller observation (n = 513).
A total of 1078 patients responded to induction therapy, of which 1018 were randomised to MabThera maintenance therapy (n=505) or observation (n=513).
• MabThera gives samme dag som kemoterapien.
• MabThera will be given to you on the same day as your chemotherapy.
Hvis du behandles for granulomatose med polyangiitis eller mikroskopisk polyangiitis Hvert behandlingsforløb består af fire separate infusioner, der gives med én uges mellemrum.
d) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis Treatment with MabThera uses four separate infusions given at weekly intervals.
MabThera subkutan
MabThera subcutaneous