FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients were followed until month 28 (10 or 6 months, respectively, after the last MabThera infusion or azathioprine dose).
Danish: Alle patienter blev fulgt til måned 28 (10 eller 6 måneder efter den sidste henholdsvis MabTherainfusion eller azathioprin-dosis).
English: Predicted median Cmax (q2m) µg/mL Predicted median Cmax (q3m) µg/mL
Danish: Forventet median Cmax (q2m) µg/ml Forventet median Cmax (q3m) µg/mL
English: A total of 176 patients with CLL were randomized into the following two treatment groups:
Danish: I alt 176 patienter med CLL blev randomiseret til én af følgende to behandlingsarme:
English: Unopened vial 36 months
Danish: Uåbnet hætteglas 36 måneder
English: Your doctor may prescribe MabThera for the treatment of:
Danish: Din læge kan ordinere MabThera til behandling for:
English: • hearing loss, loss of other senses b) If you are being treated for rheumatoid arthritis Very common side effects (may affect more than 1 in 10 people):
Danish: • høretab og tab af andre sanser b) Hvis du behandles for reumatoid artrit Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter):
English: Twenty nine (0.48%) post-dose observations (all from trial BP22333) were below the quantification limit.
Danish: 29 (0,48%) observationer efter dosering (alle fra Studie BP22333) var under kvantificeringsgrænsen.
English: Rarely, some of these side effects have been fatal.
Danish: Sjældent har nogle af disse bivirkninger været dødelige.
English: From month 12 to month 18, 8 relapses were observed in the MabThera group compared with four in the cyclophosphamide group.
Danish: Fra måned 12 til måned 18 observeredes 8 tilfælde af relaps i MabTheragruppen sammenlignet med 4 i cyclophosphamid-gruppen.
English: There were no missing covariate values except baseline B-cell count.
Danish: Der var ingen manglende kovariatværdier bortset fra B-celleværdier ved baseline.
English: Mean Change in SF-36 PHS
Danish: Gennemsnitsændring i SF-36 PHS
English: • you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis,
Danish: • du har svært nedsat hjertefunktion eller svær, ukontrolleret hjertesygdom og har reumatoid artrit,
English: † Outcome at 24 weeks
Danish: † Resultat ved uge 24
English: Trial BO22334 (SABRINA)
Danish: Studie BO22334 (SABRINA)
English: MabThera was given in combination with intravenous glucocorticoids which may reduce the incidence and severity of these events.
Danish: MabThera blev givet i kombination med intravenøst glukokortikoid, som kan reducere incidensen og sværhedsgraden af sådanne hændelser.
English: MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Danish: Du får MabThera af en læge eller sygeplejerske med erfaring i denne behandling.
English: Of 67 patients evaluated for HAMA, no responses were noted.
Danish: Hos 67 patienter, der blev vurderet for HAMA, fandtes intet respons.
English: Neither age, sex, lymphoma grade, initial diagnosis, presence or absence of bulky disease, normal or high LDH nor presence of extranodal disease had a statistically significant effect (Fisher's exact test) on response to MabThera.
Danish: Hverken alder, køn, lymfomgrad, initial diagnose, tilstedeværelse eller fravær af udbredt sygdom, normal eller høj LD, eller tilstedeværelse af ekstranodal sygdom havde statistisk signifikant effekt (Fisher's exact test) på responset på MabThera.
English: +myocardial infarction4 and 6,
Danish: +myokardieinfarkt4 og 6,
English: The Physician information, Patient information and Patient Alert Card must be agreed with the National Competent Authorities prior to distribution.
Danish: Informationsmaterialet til lægen, informationsmaterialet til patienten samt patientkortet skal godkendes af den nationale sundhedsmyndighed, inden materialerne distribueres.
English: Mean change in HAQ-DI
Danish: Gennemsnitsændring i HAQ-DI
English: The overall proportion of patients found to have anti-rHuPH20 antibodies remained generally constant over the follow-up period in both cohorts.
Danish: Den overordnede andel af patienter med anti-rHuPH20-antistoffer forblev i opfølgningsperioden generelt konstant i begge kohorter.
English: You should also tell them about your MabThera treatment.
Danish: Du skal også fortælle dem om din MabThera-behandling.
English: The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p < 0.0001)
Danish: Den “primære” statistiske test for “respons” var trend-testen af CR versus PR versus non-respons (p < 0,0001)
English: Currently, there are limited data on possible drug interactions with MabThera.
Danish: På nuværende tidspunkt er der begrænsede data om mulige lægemiddelinteraktioner med MabThera.
English: The safety and efficacy of MabThera in children below 18 years has not been established.
Danish: MabTheras sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Table 16 Percentage of patients who achieved complete remission at 6 months (Intent-to-treat population*)
Danish: Tabel 16 Procentdel af patienter, der opnåede fuldstændig remission ved måned 6 (ITTpopulation*)
English: % HAQ-DI MCID Mean change in FACIT-T
Danish: % HAQ-DI MCID Gennemsnitsændring i FACIT-T
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6)
Danish: • du er allergisk over for rituximab, andre proteiner, der ligner rituximab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6)
English: Some local cutaneous reactions occurred more than 24 hours after the MabThera subcutaneous administration.
Danish: Nogle lokale kutane reaktioner opstod mere end 24 timer efter den subkutane administration af MabThera.
English: No patients in the MabThera arm had fatal adverse events.
Danish: Ingen patienter i MabThera-armen havde dødelige bivirkninger.
English: As with the intravenous formulation, MabThera subcutaneous formulation should be administered in an environment where full resuscitation facilities are immediately available and under the close supervision of an experienced healthcare professional.
Danish: Som med intravenøs formulering, skal MabThera subkutan formulering administreres i et miljø, hvor der er umiddelbar adgang til komplet genoplivningsudstyr og under tæt supervision af erfarent sundhedspersonale.
English: MabThera slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
Danish: MabThera bremser beskadigelsen af dine led forårsaget af reumatoid artrit og forbedrer din evne til at udføre normale daglige aktiviteter.
English: Trial BP22333 (SparkThera)
Danish: Studie BP22333 (SparkThera)
English: Based on popPK analysis an absolute bioavailability of 71% was estimated.
Danish: På baggrund af en farmakokinetisk populationsanalyse estimeres en absolut biotilgængelighed på 71 %.
English: Based on popPK analysis of study BO25341 (SAWYER) an absolute bioavailability of 68.4% was estimated.
Danish: På baggrund af en farmakokinetisk populationsanalyse af studie BO25341 (SAWYER) estimeres en absolut biotilgængelighed på 68,4 %.
English: • bacterial or viral infections, bronchitis
Danish: • bakterie- eller virusinfektioner, bronkitis
English: There is no evidence of dysmorphogenesis (i.e. teratogenesis) resulting from systemic exposure to rHuPH20.
Danish: Der sås ingen tegn på dysmorfogenese (dvs. teratogenese) stammende fra systemisk optagelse af rHuPH20.
English: A longer period may be appropriate in patients with an increased risk of hypersensitivity reactions.
Danish: Det kan være relevant med længere observation, hvis patienten har øget risiko for overfølsomhedsreaktioner.
English: % SF-36 PHS MCID Mean change in SF-36 MHS % SF-36 MHS MCID
Danish: % SF-36 PHS MCID Gennemsnitsændring i SF-36 MHS % SF-36 MHS MCID
English: Of 356 patients evaluated for ADA, 1.1 % (4 patients) were positive.
Danish: Af 356 patienter, der blev vurderet for ADA, var 1,1 % (4 patienter) positive.
English: Baseline tumour load was available only in trial BO22334.
Danish: Tumorbyrde ved baseline var kun tilgængelig i Studie BO22334.
English: This compares favourably with the TTP achieved after the prior course of MabThera (12.4 months).
Danish: Det svarer til, hvad der blev opnået efter den første serie med MabThera (12,4 måneder).
English: For these reasons MabThera should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Danish: Derfor bør MabThera ikke gives til gravide kvinder, medmindre den potentielle gevinst opvejer den potentielle risiko.
English: Many patients get some local side effects where MabThera is injected.
Danish: Mange patienter får lokale bivirkninger der, hvor medicinen er sprøjtet ind.
English: OSHO-39 MCP, 96 R-MCP, 105
Danish: MCP, 96 R-MCP, 105
English: There are no data on the safety of MabThera in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
Danish: Der er ingen data om sikkerheden af MabThera til patienter med moderat hjerteinsufficiens (NYHA klasse III) eller alvorlig, ukontrolleret hjertesygdom.
English: Primary efficacy
Danish: Primær effekt
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of MabThera maintenance therapy, up to 5 years.
Danish: For patienter, som kan have højere risiko for recidiv, bør lægen overveje en længerevarende vedligeholdelsebehandling med MabThera, i op til 5 år.
English: A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of MabThera.
Danish: En lille andel af patienterne havde forlænget perifer B-celle-depletion, der varede 2 år eller mere efter sidst MabThera-dosis.
English: Table 15 Summary of efficacy by baseline autoantibody status
Danish: Tabel 15 Sammenfatning af effekt baseret på autoantistof-status ved baseline
English: Initiate at a rate of 250mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes.
Danish: Begynd med en hastighed på 250 mg/time i de første 30 minutter og derefter 600 mg/time i de næste 90 minutter.
English: Recombinant human hyaluronidase (rHuPH20) L-histidine
Danish: Rekombinant humant hyalorunidase (rHuPH20) L-histidin
English: All clearance and volume parameters increased with BSA.
Danish: Alle parametre for clearence og volumen er øget med øget legemsoverfladeareal (BSA).
English: key efficacy results for the pooled analysis of 410 patients in SABRINA stages 1 and 2 are shown in table 2.
Danish: De vigtigste effektresultater fra den samlede analyse af 410 patienter i SABRINA stadie 1 og 2 er vist i tabel 2.
English: The safety profile of MabThera in patients with moderate to severe rheumatoid arthritis (RA) is summarised in the sections below.
Danish: Sikkerhedsprofilen for MabThera hos patienter med svær reumatoid artrit (RA) er sammenfattet i afsnittene nedenfor.
English: Age, gender and WHO performance status had no effect on the pharmacokinetics of MabThera.
Danish: Alder, køn, race og WHO performance status havde ingen effekt på MabTheras farmakokinetik.
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue MabThera.
Danish: Afhængig af sværhedsgraden af de infusionsrelaterede reaktioner og de nødvendige indgreb, skal MabThera-behandlingen midlertidigt eller permanent afbrydes.
English: Part 2 N = 176
Danish: 2. del N = 176
English: A slight but not significant improvement in overall survival was reported in the R-FC compared to the FC arm.
Danish: En lille men ikke signifikant forbedring af den samlede overlevelse blev rapporteret i R-FC-armen i forhold til FC-armen.
English: This analysis suggests that dose adjustment of MabThera with any of the tested covariates is not expected to result in a meaningful reduction in its pharmacokinetic variability.
Danish: Denne analyse antyder, at doseringsjusteringer baseret på de testede variable ikke forventes at give en relevant reduktion i den farmakokinetiske variation.
English: The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps:
Danish: Følgende punkter vedrørende brug og bortskaffelse af sprøjter og andre skarpe genstande bør omhyggeligt overholdes:
English: Your doctor will check if you should have any vaccines before you receive MabThera.
Danish: Din læge vil undersøge, om du bør vaccineres inden du får MabThera.
English: Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
Danish: Forkortelser: NA, ikke tilgængelig; ORR: samlet responsrate; CR: komplet respons; PR: partielt respons
English: CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
Danish: CD20 cirkulerer ikke i plasma som frit antigen og konkurrerer derfor ikke om antistofbinding.
English: The dose of 1600 mg of MabThera subcutaneous formulation was selected for the Part 2 of the study.
Danish: Dosis på 1600 mg MabThera subkutan formulering blev valgt for 2. del af studiet.
English: The comparison of predicted median Cmax data for MabThera subcutaneous formulation and intravenous formulation are summarized in Table 7.
Danish: Sammenligningen af forventet median Cmax data for MabThera i subkutan formulering og intravenøs formulering sammenfattes i tabel 7.
English: • Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Danish: • Læg alle bruge nåle og sprøjter i beholder til skarpe genstande (punktursikret éngangsbeholder).
English: • The need to check, prior to MabThera treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Danish: • Nødvendigheden af at kontrollere for infektioner, for immunsuppression, for tidligere/nuværende medicinering, der påvirker immunsystemet, og for nylige og/eller planlagte vaccinationer før behandling med MabThera påbegyndes
English: The presence of ADA may be associated with worsening of infusion or allergic reactions after the second infusion of subsequent courses.
Danish: Forekomst af ADA kan være forbundet med forværring af infusions- eller allergiske reaktioner efter den anden infusion ved efterfølgende behandlingsserier.
English: Based on the mechanism of action of MabThera and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following MabThera therapy (see section 5.1).
Danish: Baseret på MabTheras virkningsmekanisme og viden om, at B-celler spiller en vigtig rolle i at vedligeholdelsen af det normale immunrespons, kan patienterne have en øget risiko for at få en infektion efter behandling med MabThera (se pkt.
English: Additionally, no effects on semen quality were shown for rHuPH20.
Danish: Derudover sås rHuPH20 ikke at påvirke sædkvaliteten.
English: Very rare cases of fatal PML have been reported following use of MabThera.
Danish: Meget sjældne tilfælde af PML med dødeligt udfald er blevet rapporteret efter anvendelse af MabThera.
English: Of the patients originally receiving methotrexate alone, 81 % received MabThera either as rescue between weeks 16-24 or in the extension trial, before week 56.
Danish: Af de patienter, der i starten udelukkende fik methotrexat, fik 81 % MabThera enten som rescue-behandling i ugerne 16-24 eller i forlængelsen af studiet inden uge 56.
English: No studies on the effects of MabThera on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that MabThera would have no or negligible influence on the ability to drive and use machines.
Danish: Der er ikke foretaget studier af MabTheras indflydelse på evnen til at føre bil og betjene maskiner, men den farmakologiske virkning og de indtil dato rapporterede bivirkninger tyder på, at MabThera ikke, eller kun i ubetydelig grad, påvirker evnen til at føre motorkøretøj og betjene maskiner.
English: MabThera is usually taken together with another medicine called methotrexate.
Danish: MabThera bruges som regel sammen med et andet lægemiddel, kaldet methotrexat.
English: The incidence of infections that were serious or required IV antibiotics was approximately 4 per 100 patient years.
Danish: Hyppigheden af infektioner, som var alvorlige eller krævede i.v.-antibiotika, var ca. 4 pr. 100 patientår.
English: Immunomodulatory drugs may increase the risk of malignancy.
Danish: Immunmodulerende lægemidler kan øge risikoen for maligne sygdomme.
English: Three of the patients had received two courses of MabThera before enrolment and thus were given a third course in the study.
Danish: Tre patienter havde fået 2 serier med MabThera før inklusion og fik således den tredje serie i studiet.
English: The risk of disease progression was reduced by 46 % and the risk of relapse by 51 %.
Danish: Risikoen for sygdomsprogression blev reduceret med 46 % og risikoen for relaps med 51 %.
English: Number of patients
Danish: % af patienter
English: The incidence of treatment-induced/enhanced anti-rHuPH20 antibodies was 8% in the intravenous group compared with 15% in the subcutaneous group, and none of the patients who tested positive for anti-rHuPH20 antibodies tested positive for neutralizing antibodies.
Danish: Forekomsten af behandlingsinducerede/forhøjede anti-rHuPH20-antistoffer var 8 % i den intravenøse gruppe sammenlignet med 15 % i den sukutane gruppe, og ingen af de patienter, som blev testet positive for anti-rHuPH20-antistoffer, blev testet positive for neutraliserede antistoffer.
English: Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection
Danish: Patienter, som en gang har haft leverbetændelse, vil blive omhyggeligt undersøgt af lægen for tegn på denne infektion
English: The cells that are affected by MabThera help to fight infection and you should wait until the infection has passed before you are given MabThera.
Danish: Cellerne, der påvirkes af MabThera hjælper med at bekæmpe infektioner, og du bør vente med behandling med MabThera, indtil infektionen er forsvundet.
English: Keep this card with you for 2 years after your last dose of MabThera.
Danish: Opbevar dette kort på dig i 2 år efter, at du har fået den sidste MabThera-dosis.
English: None of the patients who tested positive for anti-rHuPH20 antibodies tested positive for neutralizing antibodies.
Danish: Ingen af de patienter, som blev testet positive for anti-rHuPH20-antistoffer, blev testet positive for neutraliserende antistoffer.
English: However, the higher incidence of neutropenia in patients treated with MabThera and chemotherapy was not associated with a higher incidence of infections and infestations compared to patients treated with chemotherapy alone.
Danish: Den højere hyppighed af neutropeni hos patienter behandlet med MabThera og kemoterapi var dog ikke forbundet med en højere hyppighed af infektioner og infestationer sammenlignet med patienter, som fik kemoterapi alene.
English: Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the MabThera group (12%) and eight patients in the azathioprine group (14%).
Danish: Mindre recidiver (ikke livstruende og som ikke involverede større organskader) opstod hos 7 patienter i MabThera-gruppen (12 %) og 8 patienter i azathioprin-gruppen (14 %).
English: Limited information from one study in relapsed/refractory CLL patients suggests that MabThera treatment may also worsen the outcome of primary hepatitis B infections.
Danish: Begrænset information fra et studie med relaps/refraktære CLL-patienter indikerer, at MabThera-behandling også kan forværre udfaldet af primære hepatitis B-infektioner.
English: Patients received 2 x 1000 mg intravenous infusions of MabThera or placebo in combination with MTX.
Danish: Patienterne fik 2 x 1.000 mg intravenøs infusion af MabThera eller placebo i kombination med MTX.
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed and subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Reactions attributed to hypersensitivity have been reported less frequently than those attributed to cytokine release.
Danish: Reaktioner, der tilskrives overfølsomhed, er rapporteret mindre hyppigt end reaktioner, der tilskrives cytokinfrigivelse.
English: 1) Estimates were calculated by hazard ratios
Danish: 1) Estimater beregnet ved risikoratio
English: Fourteen patients (37%) in the MabThera group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
Danish: 14 patienter (37 %) i MabThera-gruppen oplevede behandlingsrelaterede infektioner sammenlignet med 15 patienter (42 %) i standarddosis prednison-gruppen.
English: The study showed statistically significant results of MabThera and low-dose prednisone over standarddose prednisone in achieving CRoff ≥ 2 months at month 24 in PV patients (see Table 18).
Danish: Studiet viste statistisk signifikante resultater af MabThera og lavdosis prednison over standarddosis prednison ved at opnå CRoff ≥ 2 måneder ved måned 24 hos PV-patienter (se tabel 18).
English: Efficacy outcomes in MabThera treated patients were analysed based on autoantibody status prior to commencing treatment.
Danish: Resultater for effekt hos patienter behandlet med MabThera, blev analyseret på basis af autoantistofstatus forud for påbegyndt behandling.
English: Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to MabThera therapy.
Danish: Lægen bør gennemgå patientens vaccinationsstatus og følge gældende vaccinationsvejledninger inden igangsætning af MabThera behandling.
English: The best responses to MabThera are seen in those who have a positive blood test to rheumatoid factor (RF) and/or anti-Cyclic Citrullinated Peptide (anti-CCP).
Danish: Den bedste virkning af MabThera ses hos dem, som har en positiv blodprøve for reumafaktor (RF) og /eller for antistoffer mod cyklisk citrullinerede peptider (anti-CCP).
English: At minimum this should include HBsAg-status and HBcAb-status.
Danish: Som minimum bør dette inkludere HBsAg-status og HBcAB-status.
English: MabThera contains the active substance “rituximab”.
Danish: MabThera indeholder det aktive indholdsstof rituximab.
English: Overall the results confirm that MabThera subcutaneous formulation 1600 mg has a comparable benefit/risk profile to that of MabThera intravenous formulation 500 mg/m2.
Danish: Samlet set, fastslog resultaterne at MabThera subkutan formulering 1600 mg har en sammenlignelig benefit/risk profil med MabThera intravenøs formulering 500 mg/m2.
English: Other rarely-reported side-effects due to MabThera include a decreased number of white cells in the blood (neutrophils) that help to fight against infection.
Danish: Andre sjældent rapporterede bivirkninger af MabThera inkluderer nedsættelse i antallet af hvide blodlegemer (neutrofiler), som hjælper med at bekæmpe infektioner.
English: The majority of local cutaneous reactions seen following administration of MabThera subcutaneous formulation was mild or moderate and resolved without any specific treatment.
Danish: De fleste af de lokale hudreaktioner, der sås efter subkutan administration af MabThera, var lette eller moderate og forsvandt uden specifik behandling.
English: In addition to dependence on body size, time-dependent clearance was higher in subjects with higher baseline tumour size, which is consistent with target-mediated elimination.
Danish: I tillæg til, at størrelsen af kroppen har betydning for clearence, er den tids-afhængige clearence højere hos patienter med en højere baseline-turmor størrelse, hvilket er i overensstemmelse med målmedieret elimination.