FrancophonIA/ELRC3.0 huggingface dataset:
English: In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
Danish: I modsætning til cytokinfrigivelsessyndrom, optræder rigtige overfølsomhedsreaktioner typisk inden for minutter efter infusionen påbegyndes.
English: Significance levels were defined as * p<0.05, **p<0.001, ***p<0.0001.
Danish: Signifikante niveauer var defineret som * p<0,05 **p<0,001, ***p<0,0001.
English: All healthcare professionals administering MabThera subcutaneous formulation will be provided with an Educational Material (« step by step guide » and « comparison card ») to minimise the risk of off label use and administration route error.
Danish: Alt sundhedspersonale, der administrerer MabThera subkutan formulering vil modtage undervisningsmateriale (”trinvis instruktion” og ”sammenligningskort”) for at minimere risikoen for brug uden for indikation samt fejl i forbindelse med administrationsvejen.
English: (2%) following administration of MabThera subcutaneous formulation .
Danish: (2 %) efter subkutan administration af MabThera.
English: Overall, 4% of patients in the MabThera arm experienced adverse events leading to discontinuation.
Danish: Samlet set oplevede 4 % af patienterne i MabThera-armen bivirkninger der ledte til seponering.
English: The highest risk of experiencing an administration related reaction is generally observed at cycle one.
Danish: Risikoen for at opleve en administrationsrelateret reaktion er størst i første behandlingsserie.
English: Geometric mean Ctrough and geometric mean AUCτ from the BP22333 and BO22334 trials are summarized in Table 8.
Danish: Geometrisk gennemsnitligt Ctrough og geometrisk gennemsnitligt AUCτ fra Studie BP22333 og BO22334 sammenfattes i Tabel 8.
English: The estimated half-life of Mabthera subcutaneous formulation of 1600 mg is 30 days, the estimated clearance is 0.22 L/day and the volume of distribution of the central compartment is 4.65 L.
Danish: Den estimerede halveringstid for MabThera subkutan formulering, 1600 mg, er 30 dage, den estimerede clearance er 0,22 l/dag og fordelingsvolumet af det centrale kompartment er 4,65 l.
English: Patients reporting signs and symptoms of infection following MabThera therapy should be promptly evaluated and treated appropriately.
Danish: Patienter, der rapporterer signaler og symptomer på infektion efter behandling med MabThera bør straks undersøges og behandles som nødvendigt.
English: These studies support the use of MabThera with any chemotherapy.
Danish: Disse studier understøtter anvendelse af MabThera sammen med enhver kemoterapi.
English: In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following MabThera.
Danish: Hos patienter med reumatoid artrit fik 283 patienter efterfølgende behandling med et biologisk DMARD efter MabThera.
English: The trial demonstrated non-inferiority of MabThera to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Danish: Studiet viste non-inferioritet af MabThera i forhold til cyclophosphamid med hensyn til fuldstændig remission (CR) ved måned 6 (tabel 16).
English: Medicines given before each MabThera administration Before you are given MabThera, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Danish: Medicin, der gives inden hver behandling med MabThera Inden du får MabThera, vil du få anden medicin (præmedicin), der forebygger eller mindsker mulige bivirkninger.
English: There is a peel-off sticker on the glass vial that specifies the medication.
Danish: Det er et aftageligt klistermærke på hætteglasset som angiver medicinen.
English: • If you respond well to treatment, you may be given MabThera as a maintenance treatment every 2 or 3 months for two years.
Danish: • Hvis medicinen virker godt hos dig, kan du få MabThera som vedligeholdelsesbehandling hver 2. eller 3. måned i op til 2 år.
English: • you have a severe active infection at the moment • you have a weak immune system.
Danish: • du i øjeblikket har en aktiv infektion • du har et svagt immunforsvar.
English: Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome.
Danish: Yderligere behandling af patienter efter fuldstændigt ophør af kliniske fund og symptomer har sjældent resulteret i gentagelse af alvorligt cytokinfrigivelsessyndrom.
English: At Week 24, patients who were seropositive to RF and/or anti-CCP at baseline had a significantly increased probability of achieving ACR20 and 50 responses compared to seronegative patients (p=0.0312 and p=0.0096) (Table 15).
Danish: Ved uge 24 havde patienter, som ved baseline var seropositive for RF og/eller anti-CCP, en signifikant øget sandsynlighed for at opnå ACR20- og ACR50-repons sammenlignet med seronegative patienter (p=0,0312 og p=0,0096) (tabel 15).
English: Patients with active hepatitis B disease should not be treated with MabThera.
Danish: Patienter med aktiv hepatitis B sygdom bør ikke behandles med MabThera.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2 °C - 8 °C).
English: Table 7: Trial BP22333 (SparkThera): Absorption - Pharmacokinetic parameters of MabThera SC compared to MabThera IV
Danish: Tabel 7 Trial BP22333 (SparkThera): Absorption - Farmakokinetiske parametre for MabThera SC sammenlignet med MabThera i.v.
English: The emergence of ADAwas not associated with clinical deterioration or with an increased risk of reactions to subsequent infusions in the majority of patients.
Danish: Udviklingen af ADA var ikke forbundet med klinisk forværring eller øget risiko for reaktioner ved efterfølgende infusioner hos hovedparten af disse patienter.
English: None of the 99 MabThera-treated patients were ADA positive at screening.
Danish: Ingen af de 99 MabThera-behandlede patienter var ADA-positive ved screening.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs hele denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: The cumulative incidence rate curves showed that time to first major relapse was longer in patients with MabThera starting from month 2 and was maintained up to month 28 (Figure 3).
Danish: Den kumulative hyppighedskurve viste, at tiden til første større recidiv var længere hos patienter, der blev behandlet med MabThera startende fra måned 2 og blev opretholdt til måned 28 (figur 3).
English: Proportion of patients with no radiographic change
Danish: Score for ledspalteforsnævring Andel af patienter uden radiologisk forandring
English: A higher proportion of patients receiving the original MabThera/MTX treatment also had no erosive progression over 56 weeks (Table 13).
Danish: En højere andel af de patienter, der havde fået MabThera/MTX fra starten, havde ingen erosionsprogression i løbet af de 56 uger (tabel 13).
English: It remains unknown if early detection of PML and suspension of MabThera therapy may lead to similar stabilisation or improved outcome.
Danish: Det er uvist, om tidlig erkendelse af PML og seponering af MabThera-behandlingen kan føre til lignende stabilisering eller forbedret tilstand.
English: No dose reductions of MabThera are recommended.
Danish: Der er ingen anbefalinger vedrørende dosisreduktion af MabThera.
English: The rate of serious infections did not show any significant increase following multiple courses of MabThera.
Danish: Hyppigheden af alvorlige infektioner viste ingen signifikant forøgelse efter gentagne behandlingsserier med MabThera.
English: Since initial improvement of clinical symptoms may be followed by deterioration, these patients should be closely monitored until tumour lysis syndrome and pulmonary infiltration have been resolved or ruled out.
Danish: Da initial forbedring kan følges af forværring, bør disse patienter monitoreres tæt, indtil tumorlysesyndrom og lungeinfiltration er forsvundet eller udelukket.
English: In placebo-controlled periods of clinical trials, 0.94% (13/1382) of MabThera treated patients and 0.27% (2/731) of placebo patients developed severe neutropenia.
Danish: I placebokontrollerede perioder af kliniske studier udviklede 0,94 % (13/1382) af MabTherabehandlede patienter og 0,27 % (2/731) af placebo-behandlede patienter svær neutropeni.
English: Other medicines and MabThera
Danish: Anden medicin og MabThera
English: Repeated treatment courses with MabThera are possible.
Danish: Gentagne behandlingsforløb med MabThera er mulige.
English: The proportion of patients with IgG levels below the LLN was about 60% in the MabThera group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Danish: Andelen af patienter med IgG-niveauer under nedre referenceramme var ca. 60 % i MabThera-gruppen i hele behandlingsperioden på 2 år, hvorimod den faldt i observationsgruppen (36 % efter 2 år).
English: If you respond well to treatment, you may be given MabThera as a maintenance treatment.
Danish: Hvis du reagerer godt på behandlingen, kan du få MabThera som vedligeholdelsesbehandling.
English: Of 356 patients evaluated for anti-drug antibody (ADA), 1.1 % (4 patients) were positive.
Danish: Af 356 patienter, der blev vurderet for anti-lægemiddel antistof (ADA), var 1,1 % (4 patienter) positive.
English: In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the MabThera group.
Danish: I observationsgruppen steg den mediane IgG-koncentration efterfølgende til over den nedre referencegrænse, men forblev konstant i MabThera- gruppen.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given MabThera if:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, inden du får MabThera, hvis:
English: Further, a significantly higher proportion of patients achieved MCIDs for these scores (Table 14).
Danish: Derudover opnåede en signifikant højere andel af patienterne MCIDs for disse scores (tabel 14).
English: MabThera is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects.
Danish: MabThera anvendes til at behandle reumatoid artrit hos personer, der allerede har prøvet anden medicin, men hvor denne medicin enten er holdt op med at virke, ikke har virket godt nok eller har medført bivirkninger.
English: The antigen is expressed on >95 % of all B cell non-Hodgkin's lymphomas.
Danish: Antigen findes på > 95 % af alle B-celle non-Hodgkin-lymfomer.
English: Percent age of Patients with First Major Relapse
Danish: Patienter med første større recidiv i procent
English: Patients should be instructed to contact their treating physician immediately if symptoms that are suggestive of severe hypersensitivity or cytokine release syndrome occur at any time after medicinal product administration.
Danish: Patienten bør instrueres i straks at kontakte behandlende læge, hvis der på noget tidspunkt opstår symptomer tydende på alvorlig overfølsomhed eller cytokinfrigivelsessyndrom efter administration af lægemidlet.
English: Although subgroups were small, MabThera maintenance treatment provided a significant benefit in terms of overall survival for both patients responding to CHOP and patients responding to R-CHOP, although longer follow-up is required to confirm this observation.
Danish: Selvom undergrupperne var små, gav MabThera-vedligeholdelsesbehandling en signifikant fordel i form af samlet overlevelse, både for patienter, der responderede på CHOP og for patienter, der responderede på R-CHOP; længere opfølgning er dog nødvendig for at bekræfte denne observation.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following MabThera treatment, as appropriate according to local clinical practice guidelines.
Danish: Profylakse mod Pneumocystis jiroveci-pneumoni (PCP) anbefales til patienter med GPA/MPA eller PV under og efter behandling med MabThera i det omfang, det er relevant i henhold til lokale kliniske retningslinjer.
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1(ITT population) Outcome†
Danish: Tabel 12 Resultater for klinisk respons ved det primære endepunkt i studie 1 (ITT populationen)
English: This is because some people have a fall in their blood pressure while they are being given MabThera
Danish: Nogle har oplevet, at blodtrykket faldt, mens de fik MabThera
English: Table 13 Radiographic outcomes at 1 year (mITT population) Placebo+MTX MabThera+MTX 2 × 1000 mg
Danish: Tabel 13 Radiologiske resultater ved 1 år i studie 1 (mITT population) Placebo+MTX MabThera +MTX 2 × 1.000 mg
English: During the treatment course with MabThera subcutaneous formulation, other medicinal products for subcutaneous administration should preferably be given at different sites.
Danish: Under behandlingsforløbet med MabThera subkutan formulering, bør andre lægemidler til subkutan administration så vidt muligt gives andre steder.
English: µg.day/mL
Danish: µg.dag/ml
English: If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.
Danish: Hvis du får MabThera sammen med anden medicin, kan nogle bivirkninger være forårsaget af den anden medicin.
English: The information provided in this section pertains to the use of MabThera in oncology.
Danish: Informationen i dette afsnit relaterer sig til onkologisk brug af MabThera.
English: These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection.
Danish: Disse ændringer inkluderer nedsat indhold af nogle specifikke proteiner i blodet (immunglobuliner), som hjælper med at beskytte mod infektioner
English: Do not take MabThera if:
Danish: Du må ikke få MabThera, hvis:
English: by Q4 2019 (preliminary CSR) by Q4 2020 (final CSR)
Danish: Afslutning af 4. kvartal 2019 (foreløbig CSR) Afslutning af 4. kvartal 2020 (endelig CSR)
English: R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI.
Danish: R-CHOP var associeret med bedre udfald for både høj- og lavrisikopatienter i forhold til aldersjusteret IPI.
English: ACR20 ACR50 ACR70 EULAR Response (Good/Moderate) Mean Change in DAS
Danish: ACR20 ACR50 ACR70 EULAR respons (god/moderat) Gennemsnitsændring i DAS
English: In these patients the rate of clinically relevant infection while on MabThera was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
Danish: Hos disse patienter var andelen af patienter, som fik klinisk relevant infektion under MabThera-behandling, 6,01 per 100 patientår i forhold til 4,97 per 100 patientår efter behandling med det biologiske DMARD.
English: The overall safety profile was consistent with the well-established safety profile for MabThera in approved autoimmune indications, including GPA/MPA.
Danish: Den overordnede sikkerhedsprofil var i overensstemmelse med den i forvejen fastlagte sikkerhedsprofil for MabThera i godkendte autoimmune indikationer, inklusiv GPA og MPA.
English: MabThera subcutaneous formulation contains recombinant human hyaluronidase (rHuPH20), an enzyme used to increase the dispersion and absorption of co-administered substances when administered subcutaneously.
Danish: MabThera subkutan formulering indeholder rekombinant humant hyalorunidase (rHuPH20), et enzym der anvendes til at øge fordeling og absorption af samtidigt administrerede midler, når det administreres subkutant.
English: Beginning the therapy with MabThera intravenous infusion would allow a better handling of the administration reactions by slowing or stopping the intravenous infusion.
Danish: Når behandling med MabThera indledes med en intravenøs infusion forbedres muligheden for at håndtere administrationsreaktioner ved at sænke infusionshastigheden eller at stoppe den intravenøse infusion.
English: The rate of all ADRs following first MabThera exposure was highest during the first 6 months and declined thereafter.
Danish: Efter første MabThera-eksponering var hyppigheden af alle bivirkninger højest i løbet af de første 6 måneder og aftog derefter.
English: Patients were stratified by baseline disease severity (moderate or severe) and randomised 1:1 to receive either MabThera and low-dose prednisone or standard-dose prednisone.
Danish: Patienterne blev stratificeret efter baseline sygdomssværhedsgrad (moderat eller svær) og randomiseret i forholdet 1:1 til behandling med enten MabThera og lavdosis prednison eller standarddosis prednison.
English: In a further clinical study, a total of 57 severe, active GPA and MPA patients in disease remission were treated with MabThera for the maintenance of remission (see section 5.1).
Danish: I endnu et klinisk studie blev i alt 57 patienter med svær, aktiv GPA og MPA i sygdomsremission behandlet med MabThera for vedligeholdelse af remission (se pkt.
English: The most frequently reported serious infection in the MabThera group was pneumonia at a frequency of 4%.
Danish: Den hyppigst indberettede alvorlige infektion i MabTheragruppen var pneumoni med en forekomst på 4%.
English: The frequencies of ADRs reported with MabThera alone or in combination with chemotherapy are summarised in Table 1.
Danish: Hyppigheden af de bivirkninger, som er rapporteret ved MabThera alene eller i kombination med kemoterapi, er sammenfattet i Tabel 1.
English: Neutropenia was not associated with an observed increase in serious infection in MabThera-treated patients.
Danish: Neutropeni var ikke forbundet med en øget frekvens af alvorlige infektioner blandt MabTherabehandlede patienter.
English: The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3 -15).
Danish: Hyppigheden af alvorlige kardielle bivirkninger var 2,1 pr. 100 patientår (95% konfidensinterval 3-15).
English: Radiographic analysis at 2 years in Trial 1 demonstrated significantly reduced progression of structural joint damage in patients receiving MabThera in combination with methotrexate compared to methotrexate alone as well as a significantly higher proportion of patients with no progression of joint damage over the 2 year period.
Danish: Radiologisk analyse efter 2 år i studie 1 viste signifikant reduceret progression af strukturel ledskade hos patienter, som fik MabThera i kombination med methotrexat, sammenlignet med patienter, som fik methotrexat alene og viste også en signifikant højere andel af patienter uden ledskadeprogression over en periode på 2 år.
English: Data from the development programme of MabThera subcutaneous formulation indicate that the formation of anti-rituximab antibodies after subcutaneous administration is comparable with that observed after intravenous administration.
Danish: Data fra udviklingsprogrammet for den sukutane formulering af MabThera indikerer, at dannelsen af anti-rituximab-antistoffer efter subkutan administration er sammenlignelig med dannelsen efter intravenøs administration.
English: The majority of these patients were also exposed to cytotoxic chemotherapy.
Danish: Hovedparten af disse patienter fik også cytotoksisk kemoterapi.
English: The most commonly reported serious infection in the MabThera group was mild or moderate bronchitis.
Danish: Den mest almindelige, alvorlige infektion rapporteret i MabThera-gruppen var let eller moderat bronkitis.
English: MabThera subcutaneous formulation is not intended for intravenous administration and should be given via subcutaneous injection only.
Danish: MabThera subkutan formulering er ikke beregnet til intravenøs administration og skal kun gives som subkutan injektion.
English: A total of 392/3095 (12.7%) patients with rheumatoid arthritis tested positive for ADAin clinical studies following therapy with MabThera.
Danish: Samlet blev 392/3.095 (12,7 %) af patienterne med reumatoid artrit testet positive for ADA i kliniske studier efter behandling med MabThera.
English: MabThera subcutaneous formulation was given at a fixed dose of 1400 mg.
Danish: MabThera subkutan formulering blev givet i en fast dosis på 1400 mg.
English: Of the 99 patients treated with MabThera, 12 (12%) experienced at least one IRR.
Danish: Af de 99 patienter, der blev behandlet med MabThera, oplevede 12 (12%) mindst én infusionsrelateret reaktion.
English: Data in approximately 180 patients pre-treated with MabThera have demonstrated clinical benefit (including CR) and are supportive for MabThera re-treatment.
Danish: Data fra omtrent 180 patienter, som tidligere var behandlet med MabThera, viste klinisk fordel (inklusiv CR) og understøtter genbehandling med MabThera.
English: • Severe vision loss (sign of brain nerves damage).
Danish: • svært synstab (tegn på beskadigelse af nerver i hjernen)
English: Table 2 Efficacy results for SAWYER (BO25341) (Intent to Treat Population)
Danish: Tabel 2 Effektresultater for SAWYER (BO25341) (ITT populationen)
English: Therefore, the switch to MabThera subcutaneous formulation can only occur at the second or subsequent cycles of treatment.
Danish: Skift til MabThera subkutan formulering kan derfor kun finde sted ved den 2. eller efterfølgende behandlingsserie.
English: Following induction of remission with MabThera, maintenance treatment should be initiated no sooner than 16 weeks after the last MabThera infusion.
Danish: Efter induktion af remission med MabThera skal vedligeholdelsesbehandling initieres tidligst 16 uger efter sidste MabThera infusion.
English: Infusion/Administration-related reactions
Danish: Infusions/Administrationsrelaterede reaktioner
English: Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Danish: Kliniske manifestationer af anafylaksi kan være lignende de kliniske manifestationer, som ses ved cytokinfrigivelsessyndrom (beskrevet ovenfor).
English: Patients received 2 x 1000 mg of MabThera separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Danish: Patienterne fik 2 x 1.000 mg MabThera med to ugers interval, derudover methotrexat (10-25 mg/uge).
English: In a long-term observational safety study, 97 GPA/MPA patients received treatment with MabThera (mean of 8 infusions [range 1-28]) for up to 4 years, according to their physician's standard practice and discretion.
Danish: I et langvarigt observationssikkerhedsstudie fik 97 patienter med GPA og MPA behandling med MabThera (gennemsnitlig 8 infusioner [i intervallet 1-28]) i op til 4 år, efter lægens skøn og i henhold til standard praksis.
English: Key results from all four trials are summarized in table 3.
Danish: Nøgleresultater fra alle 4 studier er opsummeret i Tabel 3.
English: Number of responders (response rate [%]) ap-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Danish: ap-værdi er fra Fisher's exact test med mid-p korrektion b95 % konfidensinterval er korrigeret Newcombe interval
English: At month 28, major relapse (defined by the reappearance of clinical and/or laboratory signs of vasculitis activity ([BVAS] > 0) that could lead to organ failure or damage or could be life threatening) occurred in 3 patients (5%) in the MabThera group and 17 patients (29%) in the azathioprine group (p=0.0007).
Danish: Ved måned 28 opstod der større recidiver (defineret som genkomsten af kliniske og/eller laboratorie tegn på vaskulitis-aktivitet ([BVAS] > 0), der kunne føre til organsvigt eller skade eller være livstruende) hos 3 patienter (5 %) i MabThera-gruppen og 17 patienter (29 %) i azathioprin-gruppen (p=0,0007).
English: MabThera is used for the treatment of rheumatoid arthritis.
Danish: MabThera anvendes til behandling af reumatoid artrit.
English: The risk of disease progression was reduced by 46% and the risk of relapse by 51%.
Danish: Risiko for sygdomsprogression blev reduceret med 46 %, og risikoen for recidiv med 51 %.