natgillin/translations-raw huggingface dataset:
Der blev rapporteret tilfælde af grad 3 eller 4 arytmi (inklusive ventrikulær og supraventrikulær takykardi) og angina pectoris under infusion.
Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported.
• et kompleks af symptomer, som forekommer inden for nogle få uger efter en infusion med MabThera, herunder allergiske reaktioner, såsom udslæt, kløe, ledsmerter, hævede lymfekirtler og feber
• A complex of symptoms occurring within a few weeks of an infusion of MabThera including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
Patienter i MabThera-gruppen, som oplevede recidiv, kunne få en yderligere infusion med MabThera 1.000 mg i kombination med genindført eller optitreret prednison-dosis.
Patients in the MabThera group who relapsed could receive an additional infusion of MabThera 1000 mg in combination with reintroduced or escalated prednisone dose.
Andre rapporterede alvorlige bivirkninger omfatter hepatitis B-reaktivering og PML (se pkt.
Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.
Det anbefales, at immunglobulinniveauer måles før initiering af MabThera-behandling.
It is recommended that immunoglobulin levels are determined prior to initiating treatment with MabThera.
Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som kan forventes at udskrive MabThera, har modtaget følgende:
The MAH must ensure that all physicians who are expected to prescribe MabThera are provided with the following:
Hver pakning indeholder et hætteglas.
Each carton contains one vial.
Forekomsten af symptomer på infusionsrelaterede reaktioner var højest under eller efter første infusion (9 %) og faldt med gentagende infusioner (< 4 %).
The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions (<4%).
Formålet med 2. del var at fastslå non-inferioriteten i observerede Ctrough-niveauer mellem den valgte MabThera subkutane dosis og reference Mabthera intravenøs dosis.
The objective of the Part 2 was to establish the non-inferiority in observed Ctrough levels between the selected MabThera subcutaneous dose and the reference MabThera intravenous dose.
Analysen af alle sekundære parametre (responsrate, progressionsfri overlevelse, sygdomsfri overlevelse, varighed af respons) bekræftede behandlingseffekten af R-CHOP i forhold til CHOP.
The analysis of all secondary parameters (response rates, progression-free survival, disease-free survival, duration of response) verified the treatment effect of R-CHOP compared to CHOP.
Der er ikke observeret uforligeligheder mellem MabThera og polyvinylchlorid eller polyethylen infusionsposer eller infusionssæt.
No incompatibilities between MabThera and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
CHOP, 205 R-CHOP, 223
GLSG'00 CHOP, 205 R-CHOP, 223 18
MabThera er indiceret hos voksne til Non-Hodgkin-lymfom (NHL):
MabThera is indicated in adults for Non-Hodgkin's lymphoma (NHL):
Brug af MabThera kan være forbundet med øget risiko for progressiv multifokal leukoencefalopati (PML).
Use of MabThera may be associated with an increased risk of progressive multifocal leukoencephalopathy (PML).
Det gælder også medicin, der ikke er på recept og naturlægemidler.
This includes medicines obtained without a prescription and herbal medicines.
Rituximab er et gensplejset chimerisk muse/humant monoklonalt antistof der repræsenterer et glycosyleret immunglobulin med humane IgG1 konstante regioner og murine light-chain og heavy-chain variable regionssekvenser.
Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences.
I SABRINA studiet rapporteredes svære administrationsrelaterede reaktioner (grad ≥3) hos 2 patienter
In trial SABRINA, severe administration-related reactions (grade≥3) were reported in two patients
Vaccinationerne bør være gennemført senest 4 uger inden første dosis af MabThera.
Vaccination should be completed at least 4 weeks prior to first administration of MabThera.
Som det typisk ses ved monoklonale antistoffer, er de farmakokinetiske parametre for rituximab, afhængige af kropsmål.
As typical for monoclonal antibodies, rituximab PK parameters depended on body size measures.
Dosisjustering er ikke nødvendig hos ældre patienter (alder > 65 år).
No dose adjustment is required in elderly patients (aged >65 years).
Eftersom maternelt IgG imidlertid udskilles i humanmælk, og rituximab blev detekteret i mælk fra diegivende aber, bør kvinder ikke amme, når de behandles med MabThera og i 12 måneder efter afsluttet MabThera behandling.
However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with MabThera and for 12 months following MabThera treatment.
Et 2-delt fase Ib-studie der undersøgte farmakokinetik, sikkerhed og tolerabilitet af MabThera i subkutan formulering til patienter med follikulært lymfom (FL) som en del af vedligeholdelsesbehandlingen.
A two-stage phase Ib trial to investigate the pharmacokinetics, safety and tolerability of MabThera subcutaneous formulation in patients with follicular lymphoma (FL) as part of maintenance treatment.
Kumulative hyppighed over tid til første større recidiv
Figure 3: Cumulative incidence over time of first major relapse
Derimod fik tre patienter (1,5 %) cerebrovaskulære hændelser i CHOP-armen, alle i opfølgningsperioden.
In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
En vedligeholdelsesinfusion af MabThera 500 mg blev administreret ved måned 12 og 18.
Maintenance infusions of MabThera 500 mg were administered at months 12 and 18.
I det kliniske forsøg med induktion af remission udviklede 24% af patienterne i MabThera-gruppen (ét forløb) og 23% af patienterne i cyclophosphamid-gruppen neutropeni af CTC-grad 3 eller derover.
In the induction of remission clinical trial, 24% of patients in the MabThera group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
Sikkerhedsinformationen, som er samlet efter markedsføring, afspejler den forventede bivirkningsprofil, dvs. den som blev set i kliniske studier med MabThera (se pkt.
The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for MabThera (see section 4.4).
• lavt antal hvide blodlegemer med eller uden feber eller lavt antal blodplader
• low number of white blood cells with or without fever or blood cells called “platelets”
MabThera anvendt sammen med kemoterapi ødelægger disse celler, som gradvis fjernes fra kroppen ved biologiske processer.
MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Det er vigtigt at kontrollere lægemidlets etiket for at sikre, at den formulering (intravenøs eller subkutan) og styrke, der gives til patienten, er korrekt i henhold til ordinationen.
It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) and strength is being given to the patient, as prescribed.
I et studie designet til at evaluere sikkerheden af en hurtigere MabThera-infusion hos patienter med reumatoid artrit kunne patienter med moderat til svær aktiv reumatoid artrit, som ikke havde oplevet en alvorlig infusionsrelateret reaktion under eller inden for 24 timer efter deres første infusion, få en 2 timers intravenøs MabThera-infusion.
In a trial designed to evaluate the safety of a more rapid MabThera infusion in patients with rheumatoid arthritis, patients with moderate-to-severe active RA who did not experience a serious IRR during or within 24 hours of their first studied infusion were allowed to receive a 2-hour intravenous infusion of MabThera.
Signifikant forskel fra placebo ved det primære tidspunkt: * p < 0,05, **p < 0,001 ***p ≤ 0,0001
Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001
Toksisk epidermal nekrolyse (Lyells syndrom), StevensJohnsons syndrom5
Toxic Epidermal Necrolysis (Lyell's syndrome), Stevens-Johnson syndrome5
MabThera-vedligeholdelsesbehandling forlængede signifikant den mediane PFS hos patienter, der responderede på CHOP-induktionsbehandling (median PFS 37,5 måneder versus 11,6 måneder, p<0,0001) såvel som hos dem, der responderede på R-CHOP induktionsbehandling (median PFS 51,9 måneder versus 22,1 måneder, p=0,0071).
MabThera maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p< 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
CD20 findes på såvel normale som maligne B-celler, men ikke på hæmatopoietiske stamceller, pro-Bceller, normale plasmaceller eller andet normalt væv.
CD20 is found on both normal and malignant B cells, but not on haematopoietic stem cells, pro-B cells, normal plasma cells or other normal tissue.
Et aftageligt klistermærke er påsat på hætteglassene, som angiver, styrke, adminisatrationsvej og indikation.
A peel--off sticker is included on the vials which specifies the strength, route of administration and indication.
Der sås ingen forskel mellem R-CHOP- og CHOP-gruppen i forhold til incidens af andre grad 3 og 4 kardielle hændelser, inklusive hjertesvigt, myokardiesygdom og manifestationer af koronararteriesygdom.
No difference between the R-CHOP and CHOP group was observed in the incidence of other grade 3 and 4 cardiac events including heart failure, myocardial disease and manifestations of coronary artery disease.
Induktionsbehandling i kombination med kemoterapi
Initial treatment in combination with chemotherapy
MabThera kan også ændre resultaterne på de blodprøver, som lægen har bestilt.
MabThera may also cause changes in laboratory tests carried out by your doctor.
• Øvrige indholdsstoffer: Rekombinant humant hyalorunidase (rHuPH20), L-histidin, L-histidin hydrochloridmonohydrat, α,α-trehalosedihydrat, L-methionin, polysorbat 80 og vand til injektionsvæsker.
• The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 80 and water for injections.
Det er vigtigt at kontrollere lægemidlets etiket for at sikre, at den formulering (intravenøs eller subkutan), der gives til patienten, er korrekt i henhold til ordinationen.
It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) is being given to the patient, as prescribed.
Patienter, som oplever overdosis eller medicineringsfejl med MabThera, skal monitoreres tæt.
Patients who experience overdose or medication error with MabThera should be closely monitored.
Den overordnede sikkerhedsprofil var i overensstemmelse med den i forvejen fastlagte sikkerhedsprofil for MabThera i rheumatoid artrit og GPA/MPA, og ingen nye bivirkninger blev rapporteret.
The overall safety profile was consistent with the well-established safety profile of MabThera in RA and GPA/MPA and no new adverse drug reactions were reported.
I det kliniske studie med induktion af remission havde henholdsvis 27%, 58% og 51% af patienterne i Mabthera-gruppen med normale immunglobulin-niveauer ved baseline lave IgA-, IgG- og IgMniveauer ved måned 6 sammenlignet med henholdsvis 25%, 50% og 46% i cyclophosphamid-gruppen.
In the induction of remission clinical trial, at 6 months, in the MabThera group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline had low IgA, IgG and IgM levels, respectively, compared to 25%, 50% and 46% in the cyclophosphamide group.
Den samlede responsrate i intent-to-treat populationen var 48 % (95 % konfidensinterval: 41 %56 %) med 6 % komplet respons (CR) og 42 % partielt respons (PR).
The overall response rate (ORR) in the intent-to-treat (ITT) population was 48 % (CI95% 41% - 56%) with a 6% complete response (CR) and a 42 % partial response (PR) rate.
I alt 117 patienter (88 med GPA, 24 med MPA og 5 med nyre-begrænset antineutrofil cytoplasmisk antistof (ANCA)-associeret vaskulitis) i sygdomsremission blev randomiseret til at få henholdsvis azathioprin (59 patienter) eller MabThera (58 patienter) i et prospektiv, kontrolleret, åbent multicenterstudie.
A total of 117 patients (88 with GPA, 24 with MPA, and 5 with renal-limited ANCA-associated vasculitis) in disease remission were randomized to receive azathioprine (59 patients) or MabThera (58 patients) in a prospective, multi-center, controlled, open-label study.
Regelmæssige, fuldstændige blodtællinger, inklusive neutrofil- og trombocyttællinger, bør udføres under MabThera-behandling.
Regular full blood counts, including neutrophil and platelet counts, should be performed during MabThera therapy.
Du kan have behov for ekstra overvågning under din behandling med MabThera.
Your doctor may need to take special care of you during your treatment with MabThera.
Primært effektmål Progressionsfri overlevelse (median)
Primary efficacy Progression-free survival (median)
Neutropeni har været observeret under MabThera behandling og i de fleste tilfælde var den forbigående og i mild eller moderat sværhedsgrad.
Events of neutropenia were observed with MabThera treatment, the majority of which were transient and mild or moderate in severity.
Toksikologiske undersøgelser på cynomolgusaber har ikke vist anden effekt end den forventede farmakologiske fjernelse af B-celler i perifert blod og i lymfevæv.
Toxicity studies in cynomolgus monkeys have shown no other effect than the expected pharmacological depletion of B cells in peripheral blood and in lymphoid tissue.
MabThera gives altid i et drop (intravenøs infusion) i starten af behandlingen.
You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment.
Studier med MabThera til patienter med tidlig reumatoid artrit (patienter, som ikke tidligere havde været behandlet med methotrexat, og patienter, som havde et utilstrækkeligt respons på methotrexat, men som endnu ikke var behandlet med TNF-alfa hæmmere) har nået deres primære endepunkt.
Trials of MabThera in patients with early arthritis (patients without prior methotrexate treatment and patients with an inadequate response to methotrexate, but not yet treated with TNF-alpha inhibitors) have met their primary endpoints.
Lægen bør undersøge patienten for at fastslå, om symptomerne tyder på en neurologisk dysfunktion, og hvis dette er tilfældet, om symptomerne tyder på PML.
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Det perifere B-celletal faldt til under normalområdet efter den første dosis af MabThera.
Peripheral B cell counts declined below normal following completion of the first dose of MabThera.
Andelen af patienter behandlet med MabThera, som viste minimal klinisk relevant ændring (MCID) i HAQ-DI (defineret som et fald i individuel total score på > 0,22) var også højere end hos patienter, som fik methotrexat alene (tabel 14).
The proportions of MabThera treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of >0.22) was also higher than among patients receiving methotrexate alone (Table 14).
Herefter gives MabThera som en indsprøjtning under huden.
After this, you will be given MabThera as an injection under your skin.
Pakninger med 2 hætteglas.
Pack of 2 vials.
A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERANSVARLIG FOR BATCHFRIGIVELSE
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Patienterne blev behandlet med enten MabThera monoterapi (som induktionsbehandling eller vedligeholdelsesbehandling efter induktionsbehandling) eller i kombination med med kemoterapi.
These patients were treated either with MabThera monotherapy (as induction treatment or maintenance treatment following induction treatment) or in combination with chemotherapy.
MabThera er i kombination med methotrexat indiceret til behandling af svær, aktiv reumatoid artrit hos voksne patienter, som har haft et utilstrækkeligt respons på eller er intolerante over for andre sygdomsmodificerende antireumatiske lægemidler (DMARDs) inklusive en eller flere behandlinger med tumor-nekrose-faktor (TNF)-hæmmere.
MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
Efter induktion af remission med andre immunsuppresiva til standardbehandling skal MabThera vedligeholdelsesbehandling initieres i løbet af en 4 ugers periode efter opnåelse af sygdomsremission.
Following induction of remission with other standard of care immunosuppressants, MabThera maintenance treatment should be initiated during the 4 week period that follows disease remission.
De i alt 334 patienter, der opnåede komplet eller partiel remission efter induktionsbehandlingen, blev efterfølgende randomiseret til MabThera-vedligeholdelsesbehandling (n=167) eller observation (n=167).
A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to MabThera maintenance therapy (n=167) or observation (n=167).
For patienter randomiseret til vedligeholdelsesfasen i studiet var den mediane observationstid 28 måneder fra vedligeholdelsesrandomisering.
For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Ældre Dosisjustering er ikke nødvendig hos ældre patienter (alder > 65 år).
Elderly No dose adjustment is required in elderly patients (aged >65 years).
For patienter, der vejer 60-90 kg og < 60 kg, var den gennemsnitlige Ctrough værdi efter intravenøs dosering lavere, henholdsvis ca. 16 % og 34 %, sammenlignet med subkutan dosering.
For subjects weighing 60-90 kg and < 60 kg, average Ctrough values following intravenous dosing were approximately 16% and 34% lower compared to the subcutaneous regimen, respectively.
Patientkortet for MabThera for non-onkologiske indikationer skal indeholde følgende nøgleelementer:
The Patient Alert Card for MabThera in non-oncology indications should contain the following key elements:
MabThera blev administreret som to i.v.-infusioner med et interval på 15 dage.
MabThera was administered as two IV infusions separated by an interval of 15 days.
Hvis en patient udvikler PML, skal behandling med MabThera seponeres permanent.
If a patient develops PML, the dosing of MabThera must be permanently discontinued.
Der er observeret progression af Kaposis sarkom hos MabThera-eksponerede patienter med Kaposis sarkom.
Progression of Kaposi's sarcoma has been observed in MabThera-exposed patients with pre-existing Kaposi's sarcoma.
Den samlede hyppighed af infektioner var ca. 94 pr. 100 patientår hos patienter behandlet med MabThera.
The overall rate of infection was approximately 94 per 100 patient years in MabThera treated patients.
Der er efter markedsføring rapporteret svære infusionsrelaterede reaktioner med dødeligt udfald ved brug af MabThera i intravenøs formulering, med indtræden inden for 30 minutter til 2 timer efter påbegyndelse af første MabThera intravenøs infusion.
Severe infusion-related reactions with fatal outcome have been reported during post-marketing use of the MabThera intravenous formulation, with an onset ranging within 30 minutes to 2 hours after starting the first MabThera intravenous infusion.
Derfor kan vaccination med levende, virale vacciner ikke anbefales samtidig med MabThera behandling, eller mens der er perifer B-celle depletion.
Therefore vaccination with live virus vaccines is not recommended whilst on MabThera or whilst peripherally B cell depleted.
Sikkerheden ved vaccination med levende, virale vacciner efter behandling med MabThera er ikke undersøgt.
The safety of immunisation with live viral vaccines following MabThera therapy has not been studied.
Tabel 5 Bivirkninger opstået hos MabThera-behandlede patienter med pemfigus vulgaris i det kliniske studie op til måned 24
Table 5 Adverse drugs reactions for MabThera-treated pemphigus vulgaris patients in the clinical study up to month 24
I SparkThera studiet rapporteredes ingen svære administrationsrelaterede reaktioner.
In trial SparkThera, no severe administration-related reactions were reported.
I alt 64 patienter med CLL blev inkluderet i studiet på et hvilket som helst tidspunkt før serie 5 i deres behandling med intravenøs MabThera i kombination med kemoterapi.
A total of 64 patients with CLL were enrolled at any point prior to cycle 5 during their treatment with MabThera intravenous formulation in combination with chemotherapy.
I det kliniske studie med induktion af remission, som inkluderede 99 MabThera-behandlede patienter var den samlede infektionshyppighed ca. 237 pr. 100 patientår (95% konfidensinterval 197-285) ved det primære endepunkt ved måned 6.
In the clinical trial on induction of remission, which included 99 MabThera-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
I studier med MabThera hos patienter med Waldenstroms makroglobulinæmi er der observeret forbigående stigning i koncentrationerne af serum IgM efter påbegyndelse af behandlingen, som kan være forbundet med hyperviskositet og relaterede symptomer.
In studies of MabThera in patients with Waldenstrom's macroglobulinaemia, transient increases in serum IgM levels have been observed following treatment initiation, which may be associated with hyperviscosity and related symptoms.
Selvom MabThera ikke er myelosuppressivt ved monoterapi, bør der udvises forsigtighed, når det overvejes at behandle patienter med neutrofiltal på < 1,5 x 109/l og/eller trombocyttal på < 75 x 109/l, da kliniske erfaringer hos denne population er begrænsede.
Although MabThera is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
I alt 6 ud af 34 (18 %) MabThera-behandlede patienter fra det kliniske studie med vedligeholdelsesbehandling udviklede ADA.
A total of 6/34 (18%) of MabThera treated patients from the maintenance therapy clinical trial developed ADA.
De bivirkninger, der opsummeres i tabel 5, forekom alle med en hyppighed ≥ 5 % blandt MabTherabehandlede patienter med PV med en ≥ 2 % absolut forskel i forekomst mellem den MabTherabehandlede-gruppe og standarddosis prednison-gruppen op til måned 24.
Adverse drug reactions presented in Table 5 were adverse events which occurred at a rate of ≥ 5% among MabThera-treated PV patients, with a ≥ 2% absolute difference in incidence between the MabThera-treated group and the standard-dose prednisone group up to month 24.
Signifikant reduktion i funktionsindeks (HAQ-DI) og træthedsscore (FACIT-Fatigue) blev observeret hos patienter, der blev behandlet med MabThera, sammenlignet med patienter behandlet med methotrexat alene.
Significant reductions in disability index (HAQ-DI) and fatigue (FACIT-Fatigue) scores were observed in patients treated with MabThera compared to patients treated with methotrexate alone.
MabThera 500 mg koncentrat til infusionsvæske, opløsning EU/1/98/067/002
MabThera 500 mg concentrate for solution for infusion EU/1/98/067/002