natgillin/translations-raw huggingface dataset:
Der bør altid gives præmedicin bestående af et anti-pyretisk lægemiddel samt et antihistamin, f.eks. paracetamol og diphenhydramin, inden hver MabThera-administration.
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of MabThera.
MabThera monoterapi er indiceret til behandling af patienter med grad III-IV follikulært lymfom, som er resistente overfor kemoterapi eller som er i deres andet eller efterfølgende relaps efter kemoterapi.
MabThera monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
Nedsat hæmoglobin Metabolisme og ernæring Hyperkaliæmi
Decreased haemoglobin Metabolism and nutrition disorders Hyperkalaemia
For information i forhold til autoimmune indikationer henvises til produktresuméet for MabThera intravenøs formulering.
For information related to the autoimmune indications, please refer to the SmPC of MabThera intravenous formulation.
MabThera-vedligeholdelsesbehandling reducerede risiko for død med 56 % (95 % konfidensinterval; 22-75 %).
MabThera maintenance treatment reduced the risk of death by 56 % (95 % CI; 22 %-75 %).
Efter en median observationstid på 31 måneder for patienter randomiseret til induktionsfasen, forbedrede R-CHOP signifikant udfaldet af recidiveret/refraktært follikulært lymfom sammenlignet med CHOP (se Tabel 5).
After a median observation time of 31 months for patients randomised to the induction phase, R-CHOP significantly improved the outcome of patients with relapsed/refractory follicular lymphoma when compared to CHOP (see Table 5).
Immungenicitet
Immunisation
Hvis behandlingen virker, kan MabThera gives som vedligeholdelsesbehandling i 2 år efter, den første behandling er givet.
In patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment.
I første stadie af studiet blev tidligere ubehandlede patienter med CD20-positivt, follikulært lymfom af grad 1, 2, eller 3a (n=127) inkluderet.
Stage 1 enrolled previously untreated patients (n=127) CD20-positive, Follicular Lymphoma (FL) Grade 1, 2 or 3a.
Studier af tidligere ubehandlet og relaps/refraktær CLL har fastslået, at hos op til 25 % af patienterne behandlet med R-FC var neutropeni forlænget (defineret som neutrofiltal, der forblev under 1x109/l mellem dag 24 og 42 efter sidste dosis) eller indtraf sent (defineret som neutrofiltal under 1x109/l senere end dag 42 efter sidste dosis hos patienter uden tidligere forlænget neutropeni eller hos patienter, som restituerede før dag 42) efter behandling med MabThera plus FC.
Studies in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1x109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1x109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with MabThera plus FC.
MabThera intravenøs formulering
MabThera intravenous formulation
MabThera er i den intravenøse formulering anvendt til 21 patienter, som havde fået foretaget autolog knoglemarvstransplantation og til andre risikogrupper med formodet nedsat knoglemarvsfunktion uden at fremkalde myelotoksicitet.
The MabThera intravenous formulation 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.
Tre patienter i SABRINA-studiet (BO22334) med MabThera subkutan formulering fik utilsigtet administreret en subkutandosis op til et maksimum på 2.780 mg rituximab intravenøst uden bivirkninger.
Three patients in the MabThera subcutaneous formulation trial SABRINA (BO22334) were inadvertently administered subcutaneous formulation through the intravenous route up to a maximum rituximab dose of 2780 mg with no untoward effect.
En behandlingsserie med MabThera består af to intravenøse infusioner a 1.000 mg.
A course of MabThera consists of two 1000 mg intravenous infusions.
Signifikant fordel af vedligeholdelsesbehandling med MabThera blev også set for de sekundære effektmål; hændelsesfri overlevelse (EFS), tid til næste anti-lymfom-behandling (TNLT), tid til næste kemoterapibehandling (TNCT) og samlet responsrate (ORR) i den primære analyse (tabel 4).
Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 4).
MabThera 1400 mg kan anvendes alene eller sammen med kemoterapi.
MabThera 1400 mg can be given alone or with other medicines called “chemotherapy”.
Tre patienter i SABRINA-studiet (BO22334) med MabThera subkutan NHL formulering fik utilsigtet administreret en subkutandosis op til et maksimum på 2.780 mg rituximab intravenøst uden bivirkninger.
Three patients in the MabThera subcutaneous NHL formulation trial SABRINA (BO22334) were inadvertently adminstered subcutaneous formulation through the intravenous route up to a maximum rituximab dose of 2780 mg with no untoward effect.
Formålet med det første del var at bestemme den subkutane dosis af MabThera, som gav serum Ctroughniveauer, der var sammenlignelige med den intravenøse formulering af MabThera.
The objective of the Part 1 was to select a MabThera subcutaneous formulation dose that resulted in comparable MabThera serum Ctrough levels compared with MabThera intravenous formulation.
Signifikant fordel af vedligeholdelsesbehandling med MabThera blev også set for de sekundære effektmål; hændelsesfri overlevelse (EFS), tid til næste anti-lymfom-behandling (TNLT), tid til næste kemoterapibehandling (TNCT) og samlet responsrate (ORR) i den primære analyse (tabel 7).
Significant benefit from maintenance treatment with MabThera was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 7).
I del 2 blev MabThera administreret som subkutan formulering i en fast dosis på 1400 mg ved subkutan injektion, i vedligeholdelsesbehandlingen efter mindst én behandlingsserie med MabThera intravenøs formulering til FL-patienter, som tidligere havde responderet på MabThera intravenøs formulering under induktionsbehandlingen.
In stage 2, MabThera subcutaneous formulation at a fixed dose of 1400 mg was administered as subcutaneous injection during maintenance treatment, after at least one cycle of MabThera intravenous formulation to FL patients who had previously responded to MabThera intravenous formulation in induction.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1600 mg/13,4 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,600 mg/13.4 mL
Hvis du har yderligere spørgsmål vedrørende brugen af MabThera, kan du kontakte lægen, apotekspersonalet eller sundhedspersonalet.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Specielle populationer - MabThera monoterapi
Patient subpopulations - MabThera monotherapy
Lægemidler til behandling af hypersensitivitetsreaktioner, for eksempel epinephrin (adrenalin), antihistaminer og glukokortikoider, bør være tilgængelige til øjeblikkelig anvendelse, i tilfælde af en allergisk reaktion under administration af MabThera.
Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of MabThera.
Neurologiske sygdomme
Neurologic events
Overfølsomhed over for det aktive stof, murine proteiner, hyalorunidase eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to the active substance or to murine proteins, hyaluronidase or to any of the other excipients listed in section 6.1.
Geometrisk gennemsnitligt AUCτ behandlingsseriee 2 (q3m)
Geometric mean AUCτ cycle 2 (q3m)
Gennemsnittet af præterapeutiske antistof-titer for et udvalg af antigener (Streptococcus pneumoniae, influenza A, mæslinger, røde hunde og skoldkopper) blev bibeholdt i mindst 6 måneder efter behandling med MabThera.
Mean pre-therapeutic antibody titers against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella and varicella) were maintained for at least 6 months after treatment with MabThera.
Gennemsnittet af præterapeutiske antistoftitere for et udvalg af antigener (Streptococcus pneumoniae, influenza A, mæslinger, røde hunde, skoldkopper) blev bibeholdt i mindst 6 måneder efter behandling med MabThera.
Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with MabThera.
Hætteglasset med 50 ml indeholder 500 mg rituximab (10 mg/ml)
The 50 mL vial contains 500 mg of rituximab (10 mg/mL).
MabThera--patientkort for ikke-onkologiske indikationer
PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS MabThera Alert Card for patients with non-oncology diseases
Graviditet Det vides, at IgG-immunglobuliner kan passere placentabarrieren.
IgG immunoglobulins are known to cross the placental barrier.
Hjælpestoffer: Dette lægemiddel indeholder 2,3 mmol (eller 52,6 mg) natrium pr. 10 ml hætteglas og 11,5 mmol (eller 263,2 mg) natrium pr 50 ml hætteglas.
Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial and 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Risikoen for infektioner kan øges under behandling med MabThera.
You might get infections more easily during your treatment with MabThera.
Granulomatose med polyangiitis eller mikroskopisk polyangiitis MabThera gives i kombination med binyrebarkhormon, for at behandle sygdommen granulomatose med polyangiitis (blev tidligere kaldt Wegeners granulomatose) og mikroskopisk polyangiitis.
d) Granulomatosis with polyangiitis or microscopic polyangiitis MabThera is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
De bivirkninger, der opsummeres i tabel 3, forekom alle med en hyppighed ≥ 5 % i MabTheragruppen og med en højere frekvens end sammenligningsgruppen.
The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the MabThera group and at a higher frequency than the comparator group.
De hyppigste lokale hudreaktioner i armen med subkutan MabThera var erytem ved injektionsstedet (13 %), smerter ved injektionsstedet (7 %) og ødemer ved injektionsstedet (4 %).
The most common local cutaneous reactions in the MabThera subcutaneous arm were injection site erythema (13%), injection site pain (7%), and injection site oedema (4%).
Muskuloskeletale smerter Ekstremitetssmerter Nervesystemet
Musculoskeletal pain Pain in extremities
Fordelen ved MabThera-vedligeholdelsesbehandling blev bekræftet ved alle undergruppeanalyser, uafhængigt af induktionsbehandling (CHOP eller R-CHOP) eller grad af respons på induktionsbehandling (CR eller PR) (Tabel 6).
The benefit of MabThera maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (table 6).
De mest almindelige bivirkninger, der blev anset for at være relateret til administration af MabThera, var infusionsrelaterede reaktioner.
The most frequent adverse reactions considered due to receipt of MabThera were IRRs.
Sikkerheden for vaccination med levende, virale vacciner efter MabThera behandling er ikke undersøgt hos NHL og CLL patienter, og vaccination med levende, virale vacciner kan ikke anbefales.
The safety of immunisation with live viral vaccines, following MabThera therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Den gennemsnitlige terminale halveringstid for elimination varierede fra 15 til 16 dage for doseringsgruppen 2 x 500 mg og fra 17 til 21 dage for doseringsgruppen 2 x 1.000 mg.
Mean terminal elimination half-life ranged from 15 to 16 days for the 2 x 500 mg dose group and 17 to 21 days for the 2 × 1000 mg dose group.
18-måneder p=0,016
18-months p = 0.016
Geometrisk gennemsnitligt AUCτ behandlingsserie 2 (q2m)
Geometric mean AUCτ cycle 2 (q2m)
Under vedligeholdelsesbehandling med MabThera i op til 2 år rapporteredes højere hyppighed af leukopeni (5 % versus 2 %, grad 3/4) og neutropeni (10 % versus 4 %, grad 3/4) end i observationsgruppen.
During MabThera maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia (10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation.
Andelen af patienter, der rapporterede bivirkninger efter genbehandling med flere MabThera serier var sammenlignelig med andelen af patienter, der rapporterede bivirkninger efter induktionsbehandling (alle bivirkninger og bivirkninger af grad 3/4)
The percentage of patients reporting ADRs upon re-treatment with further courses of MabThera was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
MabThera er forbundet med infusions-/administrationsrelaterede reaktioner, der kan være relateret til frigivelse af cytokiner og/eller andre kemiske mediatorer.
MabThera is associated with infusion/administration-related reactions, which may be related to release of cytokines and/or other chemical mediators.
48-måneder p=0,0096
48-months p = 0.0096
Hætteglas, af farveløst type I glas, med butylgummiprop med aluminiumsforsegling og blåt vipbart plastiklåg, indeholdende 1600 mg/13,4 ml rituximab.
Colourless type I glass vial with butyl rubber stopper with aluminium over seal and a blue plastic flip-off disk, containing 1600 mg/13.4 mL of rituximab.
For information vedrørende andre indikationer henvises til produktresuméet for MabThera intravenøs formulering.
For information related to the other indications, please refer to the SmPC of MabThera intravenous formulation.
• Non-Hodgkin-lymfom er en sygdom i lymfesystemet (en del af immunsystemet), der påvirker de hvide blodlegemer, der kaldes B-lymfocytter.
• This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes.
Anbefalet dosis af MabThera subkutan formulering til voksne er en subkutan injektion i fast dosis på 1600 mg, uafhængigt af patientens legemsoverfladeareal.
The recommended dose of MabThera subcutaneous formulation used for adult patients is a subcutaneous injection at a fixed dose of 1600 mg irrespective of the patient's body surface area.
respirationssvigt4
respiratory failure4,
Fordelen ved MabThera vedligeholdelsesbehandling blev bekræftet af alle undergruppeanalyser, uafhængigt af induktionsbehandlingen (CHOP eller R-CHOP) eller graden af respons på induktionsbehandlingen (CR eller PR) (tabel 9).
The benefit of MabThera maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (Table 9).
Denne medicin indeholder 2,3 mmol (eller 52,6 mg) natrium pr. 10 ml hætteglas og 11,5 mmol (eller 263,2 mg) natrium pr. 50 ml hætteglas.
This medicine contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial and 11.5 mmol (or 263.2 mg) per 50 mL vial.
4.4 vedrører brug af MabThera subkutan formulering i de godkendte indikationer Behandling af non-Hodgkin-lymfom (styrke 1400 mg) og Behandling af kronisk lymfatisk leukæmi (CLL) (styrke 1600 mg).
The information provided in the section 4.4 pertains to the use of MabThera subcutaneous formulation in the approved indications Treatment of non Hodgkin lymphoma (strength 1400 mg) and Treatment of CLL (strength 1600 mg).
MabThera leveres i sterile, pyrogenfri hætteglas uden konserveringsmiddel til engangsbrug.
MabThera is provided in sterile, preservative-free, non-pyrogenic, single use vials.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1400 mg/11,7 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,400 mg/11.7 mL
Hvis du har reumatoid artrit, granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris, fortæl da også din læge
If you have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
Inden subkutane injektioner med MabThera påbegyndes, skal alle patienter altid forinden have modtaget en fuld dosis MabThera som intravenøs infusion, med MabThera intravenøs formulering (se pkt.
Before starting MabThera subcutaneous injections, all patients must always receive beforehand, a full dose of MabThera by intravenous infusion, using MabThera intravenous formulation (see section 4.4).
Patienter med udbredt sygdom havde en højere hyppighed af grad 3/4 bivirkninger end patienter uden udbredt sygdom (25,6 % versus 15,4 %).
There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6 % vs. 15.4 %).
Fortyndet opløsning af lægemidlet
Diluted medicinal product
Det geometriske gennemsnits Tmax for MabThera i subkutan formulering var ca. 3 dage sammenlignet med, det Tmax, der opstod ved eller tæt på slutningen af MabThera infusion, intravenøs formulering.
The geometric mean tmax in the MabThera subcutaneous group was approximately 3 days as compared to the tmax occuring at or close to the end of the infusion for the MabThera intravenous group.
Der henvises til produktresumé for MabThera 100 mg og 500 mg koncentrat til opløsning til infusion for information vedrørende dosering og administration.
The Summary of Product Characteristics (SmPC) of MabThera 100 mg and 500 mg concentrate for solution for infusion should be referred to for information on dosing instructions and method of administration.
Der er begrænset erfaring fra kliniske studier hos mennesker med doser over den godkendte dosis af intravenøre MabThera-formuleringer.
Limited experience with doses higher than the approved dose of intravenous MabThera formulation is available from clinical trials in humans.
Responsraterne var sammenlignelige ved vaccination med tetanus recall antigen (39 % versus 42 %), der var reduceret respons over for pneumokok polysaccharid vaccine (43 % versus 82 % over for mindst to pneumokokantistof serotyper) og over for KLH neoantigen (47 % versus 93 %), når vaccinationen blev givet 6 måneder efter MabThera-behandling.
In a randomised trial, patients with rheumatoid arthritis treated with MabThera and methotrexate had comparable response rates to tetanus recall antigen (39% vs. 42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs. 82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs. 93%), when given 6 months after MabThera as compared to patients only receiving methotrexate.
Anbefalet dosis af MabThera subkutan formulering til voksne er en subkutan injektion i fast dosis på 1400 mg, uafhængigt af patientens legemsoverfladeareal.
The recommended dose of MabThera subcutaneous formulation used for adult patients is a subcutaneous injection at a fixed dose of 1400 mg irrespective of the patient's body surface area.
Brugen af MabThera subkutan formulering som monoterapi kan ikke anbefales hos patienter med stadium III-IV follikulært lymfom, som er resistente over for kemoterapi eller som oplever 2. eller efterfølgende recidiv efter kemoterapi, da sikkerheden af én gang ugentlig subkutan administration, endnu ikke er klarlagt.
The use of MabThera subcutaneous formulation as monotherapy in patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy cannot be recommended as the safety of the once weekly subcutaneous administration has not been established.
I to åbne, randomiserede studier blev 817 tidligere ubehandlede patienter og 552 patienter med relaps/refraktær CLL randomiseret til enten FC-kemoterapi (fludarabin 25 mg/m2, cyclophosphamid 250 mg/m2, på dag 1-3) hver 4. uge i 6 serier eller MabThera i kombination med FC (R-FC).
In two open-label randomised trials, a total of 817 previously untreated patients and 552 patients with relapsed/refractory CLL were randomised to receive either FC chemotherapy (fludarabine 25 mg/m2, cyclophosphamide 250 mg/m2, days 1-3) every 4 weeks for 6 cycles or MabThera in combination with FC (R-FC).
Når du behandles med MabThera i kombination med kemoterapi, vil du få en MabThera intravenøs infusion på dag 0 i behandlingsserie 1.
When you are treated with MabThera in combination with chemotherapy, you will receive a MabThera infusion on day 0 of cycle 1, then subcutaneous injections on day 1 of each subsequent cycle.
Styrken på 1400 mg er kun beregnet til subkutan brug hos patienter med nonHodgkin-lymfom.
The 1400 mg strength is intended for subcutaneous use in non Hodgkin lymphoma (NHL) only.
Systemorganklasser Bivirkninger1
System Organ Class Adverse drug reaction1
Hos patienter med non-Hodgkin-lymfom og CLL bør det overvejes at give præmedicinering med glukokortikoider, hvis MabThera ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
In patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy.
MabThera bør gives på dag 1 i hver kemoterapiserie, efter administration af glukokortikoidkomponenten, hvis det anvendes.
MabThera should be administered on day 1 of each chemotherapy cycle, after administration of the glucocorticoid component of the chemotherapy if applicable.
Der bør altid gives præmedicin bestående af et analgetisk/anti-pyretisk middel samt et antihistamin inden hver subkutane administration af MabThera.
Premedication consisting of an analgesic/antipyretic and an antihistamine should always be administered before each dose of MabThera subcutaneous formulation.
Ligeledes, for patienter, der har et højt BSA, var Ctrough værdien ens for intravenøs dosering og subkutan dosering.
Similarly, for subjects in the high BSA tritile, Ctrough values were the same for the intravenous and subcutaneous regimens.
Information som skal fremgå på et aftageligt klistermærke Lot
Information to appear on Peel-off sticker
Hætteglas, af farveløst type I glas, med butylgummiprop med aluminiumsforsegling og lyserødt vipbart plastiklåg, indeholdende 1400 mg/11,7 ml rituximab.
Colourless type I glass vial with butyl rubber stopper with aluminium over seal and a pink plastic flip-off disk, containing 1400 mg/11.7 mL of rituximab.
MabThera blev givet på den første dag i behandlingsserien.
MabThera was administered on the first day of the treatment cycle.
Der er i kliniske studier set administrationsrelaterede reaktioner hos op til 50 % af patienter behandlet med MabThera subkutan formulering.
Administration related reactions have been observed in up to 50% of patients treated with MabThera subcutaneous formulation in clinical trials.
Patienter med recidiv n=51
Relapsing n=51
Det er vigtigt, fordi MabThera i enkelte tilfælde har forårsaget, at en tidligere leverbetændelse (hepatitis B) er blevet aktiv igen.
This is because in a few cases, MabThera could cause hepatitis B to become active again, which can be fatal in very rare cases.
Der er i meget sjældne tilfælde blevet rapporteret om tilfælde af progressiv multifokal leukoencefalopati (PML) efter markedsføring af MabThera hos patienter med NHL og CLL (se pkt.
Very rare cases of progressive multifocal leukoencephalopathy (PML) have been reported during post-marketing use of MabThera in NHL and CLL (see section 4.8).
Den samlede responsrate efter behandlingsserie 8 var 76,2 % i R-CHOP-gruppen sammenlignet med 62,4 % i CHOP-gruppen (p=0,0028).
The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).