natgillin/translations-raw huggingface dataset:
• 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 
• 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
Forekomst af ADA kan være forbundet med forværring af infusions- eller allergiske reaktioner efter den anden infusion ved efterfølgende behandlingsserier. 
The presence of ADA may be associated with worsening of infusion or allergic reactions after the second infusion of subsequent courses.
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. 
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).
Derudover sås rHuPH20 ikke at påvirke sædkvaliteten. 
Additionally, no effects on semen quality were shown for rHuPH20.
Meget sjældne tilfælde af PML med dødeligt udfald er blevet rapporteret efter anvendelse af MabThera. 
Very rare cases of fatal PML have been reported following use of MabThera.
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. 
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.
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. 
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.
MabThera bruges som regel sammen med et andet lægemiddel, kaldet methotrexat. 
MabThera is usually taken together with another medicine called methotrexate.
Hyppigheden af infektioner, som var alvorlige eller krævede i.v.-antibiotika, var ca. 4 pr. 100 patientår. 
The incidence of infections that were serious or required IV antibiotics was approximately 4 per 100 patient years.
Immunmodulerende lægemidler kan øge risikoen for maligne sygdomme. 
Immunomodulatory drugs may increase the risk of malignancy.
Tre patienter havde fået 2 serier med MabThera før inklusion og fik således den tredje serie i studiet. 
Three of the patients had received two courses of MabThera before enrolment and thus were given a third course in the study.
Risikoen for sygdomsprogression blev reduceret med 46 % og risikoen for relaps med 51 %. 
The risk of disease progression was reduced by 46 % and the risk of relapse by 51 %.
% af patienter 
Number of patients
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. 
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.
Patienter, som en gang har haft leverbetændelse, vil blive omhyggeligt undersøgt af lægen for tegn på denne infektion 
Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection
Cellerne, der påvirkes af MabThera hjælper med at bekæmpe infektioner, og du bør vente med behandling med MabThera, indtil infektionen er forsvundet. 
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.
Opbevar dette kort på dig i 2 år efter, at du har fået den sidste MabThera-dosis. 
Keep this card with you for 2 years after your last dose of MabThera.
Ingen af de patienter, som blev testet positive for anti-rHuPH20-antistoffer, blev testet positive for neutraliserende antistoffer. 
None of the patients who tested positive for anti-rHuPH20 antibodies tested positive for neutralizing antibodies.
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. 
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.
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 %). 
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%).
Begrænset information fra et studie med relaps/refraktære CLL-patienter indikerer, at MabThera-behandling også kan forværre udfaldet af primære hepatitis B-infektioner. 
Limited information from one study in relapsed/refractory CLL patients suggests that MabThera treatment may also worsen the outcome of primary hepatitis B infections.
Patienterne fik 2 x 1.000 mg intravenøs infusion af MabThera eller placebo i kombination med MTX. 
Patients received 2 x 1000 mg intravenous infusions of MabThera or placebo in combination with MTX.
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. 
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.
Reaktioner, der tilskrives overfølsomhed, er rapporteret mindre hyppigt end reaktioner, der tilskrives cytokinfrigivelse. 
Reactions attributed to hypersensitivity have been reported less frequently than those attributed to cytokine release.
1) Estimater beregnet ved risikoratio 
1) Estimates were calculated by hazard ratios
14 patienter (37 %) i MabThera-gruppen oplevede behandlingsrelaterede infektioner sammenlignet med 15 patienter (42 %) i standarddosis prednison-gruppen. 
Fourteen patients (37%) in the MabThera group experienced treatment-related infections compared to 15 patients (42%) in the standard-dose prednisone group.
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). 
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).
Resultater for effekt hos patienter behandlet med MabThera, blev analyseret på basis af autoantistofstatus forud for påbegyndt behandling. 
Efficacy outcomes in MabThera treated patients were analysed based on autoantibody status prior to commencing treatment.
Lægen bør gennemgå patientens vaccinationsstatus og følge gældende vaccinationsvejledninger inden igangsætning af MabThera behandling. 
Physicians should review the patient's vaccination status and follow current immunisation guidelines prior to MabThera therapy.
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). 
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).
Som minimum bør dette inkludere HBsAg-status og HBcAB-status. 
At minimum this should include HBsAg-status and HBcAb-status.
MabThera indeholder det aktive indholdsstof rituximab. 
MabThera contains the active substance “rituximab”.
Samlet set, fastslog resultaterne at MabThera subkutan formulering 1600 mg har en sammenlignelig benefit/risk profil med MabThera intravenøs formulering 500 mg/m2. 
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.
Andre sjældent rapporterede bivirkninger af MabThera inkluderer nedsættelse i antallet af hvide blodlegemer (neutrofiler), som hjælper med at bekæmpe infektioner. 
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.
De fleste af de lokale hudreaktioner, der sås efter subkutan administration af MabThera, var lette eller moderate og forsvandt uden specifik behandling. 
The majority of local cutaneous reactions seen following administration of MabThera subcutaneous formulation was mild or moderate and resolved without any specific treatment.
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. 
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.
I modsætning til cytokinfrigivelsessyndrom, optræder rigtige overfølsomhedsreaktioner typisk inden for minutter efter infusionen påbegyndes. 
In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
Signifikante niveauer var defineret som * p<0,05 **p<0,001, ***p<0,0001. 
Significance levels were defined as * p<0.05, **p<0.001, ***p<0.0001.
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. 
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.
(2 %) efter subkutan administration af MabThera. 
(2%) following administration of MabThera subcutaneous formulation .
Samlet set oplevede 4 % af patienterne i MabThera-armen bivirkninger der ledte til seponering. 
Overall, 4% of patients in the MabThera arm experienced adverse events leading to discontinuation.
Risikoen for at opleve en administrationsrelateret reaktion er størst i første behandlingsserie. 
The highest risk of experiencing an administration related reaction is generally observed at cycle one.
Geometrisk gennemsnitligt Ctrough og geometrisk gennemsnitligt AUCτ fra Studie BP22333 og BO22334 sammenfattes i Tabel 8. 
Geometric mean Ctrough and geometric mean AUCτ from the BP22333 and BO22334 trials are summarized in Table 8.
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. 
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.
Patienter, der rapporterer signaler og symptomer på infektion efter behandling med MabThera bør straks undersøges og behandles som nødvendigt. 
Patients reporting signs and symptoms of infection following MabThera therapy should be promptly evaluated and treated appropriately.
Disse studier understøtter anvendelse af MabThera sammen med enhver kemoterapi. 
These studies support the use of MabThera with any chemotherapy.
Hos patienter med reumatoid artrit fik 283 patienter efterfølgende behandling med et biologisk DMARD efter MabThera. 
In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following MabThera.
Studiet viste non-inferioritet af MabThera i forhold til cyclophosphamid med hensyn til fuldstændig remission (CR) ved måned 6 (tabel 16). 
The trial demonstrated non-inferiority of MabThera to cyclophosphamide for complete remission (CR) at 6 months (Table 16).
Medicin, der gives inden hver behandling med MabThera Inden du får MabThera, vil du få anden medicin (præmedicin), der forebygger eller mindsker mulige bivirkninger. 
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.
Det er et aftageligt klistermærke på hætteglasset som angiver medicinen. 
There is a peel-off sticker on the glass vial that specifies the medication.
• Hvis medicinen virker godt hos dig, kan du få MabThera som vedligeholdelsesbehandling hver 2. eller 3. måned i op til 2 år. 
• If you respond well to treatment, you may be given MabThera as a maintenance treatment every 2 or 3 months for two years.
• du i øjeblikket har en aktiv infektion • du har et svagt immunforsvar. 
• you have a severe active infection at the moment • you have a weak immune system.
Yderligere behandling af patienter efter fuldstændigt ophør af kliniske fund og symptomer har sjældent resulteret i gentagelse af alvorligt cytokinfrigivelsessyndrom. 
Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome.
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). 
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).
Patienter med aktiv hepatitis B sygdom bør ikke behandles med MabThera. 
Patients with active hepatitis B disease should not be treated with MabThera.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2 °C - 8 °C). 
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C).
Tabel 7 Trial BP22333 (SparkThera): Absorption - Farmakokinetiske parametre for MabThera SC sammenlignet med MabThera i.v. 
Table 7: Trial BP22333 (SparkThera): Absorption - Pharmacokinetic parameters of MabThera SC compared to MabThera IV
Udviklingen af ADA var ikke forbundet med klinisk forværring eller øget risiko for reaktioner ved efterfølgende infusioner hos hovedparten af disse patienter. 
The emergence of ADAwas not associated with clinical deterioration or with an increased risk of reactions to subsequent infusions in the majority of patients.
Ingen af de 99 MabThera-behandlede patienter var ADA-positive ved screening. 
None of the 99 MabThera-treated patients were ADA positive at screening.
Læs hele denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger. 
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
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). 
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).
Score for ledspalteforsnævring Andel af patienter uden radiologisk forandring 
Proportion of patients with no radiographic change
En højere andel af de patienter, der havde fået MabThera/MTX fra starten, havde ingen erosionsprogression i løbet af de 56 uger (tabel 13). 
A higher proportion of patients receiving the original MabThera/MTX treatment also had no erosive progression over 56 weeks (Table 13).
Det er uvist, om tidlig erkendelse af PML og seponering af MabThera-behandlingen kan føre til lignende stabilisering eller forbedret tilstand. 
It remains unknown if early detection of PML and suspension of MabThera therapy may lead to similar stabilisation or improved outcome.
Der er ingen anbefalinger vedrørende dosisreduktion af MabThera. 
No dose reductions of MabThera are recommended.
Hyppigheden af alvorlige infektioner viste ingen signifikant forøgelse efter gentagne behandlingsserier med MabThera. 
The rate of serious infections did not show any significant increase following multiple courses of MabThera.
Da initial forbedring kan følges af forværring, bør disse patienter monitoreres tæt, indtil tumorlysesyndrom og lungeinfiltration er forsvundet eller udelukket. 
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.
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. 
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.
Anden medicin og MabThera 
Other medicines and MabThera
Gentagne behandlingsforløb med MabThera er mulige. 
Repeated treatment courses with MabThera are possible.
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). 
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).
Hvis du reagerer godt på behandlingen, kan du få MabThera som vedligeholdelsesbehandling. 
If you respond well to treatment, you may be given MabThera as a maintenance treatment.
Af 356 patienter, der blev vurderet for anti-lægemiddel antistof (ADA), var 1,1 % (4 patienter) positive. 
Of 356 patients evaluated for anti-drug antibody (ADA), 1.1 % (4 patients) were positive.
I observationsgruppen steg den mediane IgG-koncentration efterfølgende til over den nedre referencegrænse, men forblev konstant i MabThera- gruppen. 
In the observation group, the median IgG level subsequently increased to above the LLN, but remained constant in the MabThera group.
Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, inden du får MabThera, hvis: 
Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given MabThera if:
Derudover opnåede en signifikant højere andel af patienterne MCIDs for disse scores (tabel 14). 
Further, a significantly higher proportion of patients achieved MCIDs for these scores (Table 14).
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. 
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.
Antigen findes på > 95 % af alle B-celle non-Hodgkin-lymfomer. 
The antigen is expressed on >95 % of all B cell non-Hodgkin's lymphomas.
Patienter med første større recidiv i procent 
Percent age of Patients with First Major Relapse
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. 
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.
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. 
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.
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. 
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.
Tabel 12 Resultater for klinisk respons ved det primære endepunkt i studie 1 (ITT populationen) 
Table 12 Clinical response outcomes at primary endpoint in Trial 1(ITT population) Outcome†
Nogle har oplevet, at blodtrykket faldt, mens de fik MabThera 
This is because some people have a fall in their blood pressure while they are being given MabThera
Tabel 13 Radiologiske resultater ved 1 år i studie 1 (mITT population) Placebo+MTX MabThera +MTX 2 × 1.000 mg 
Table 13 Radiographic outcomes at 1 year (mITT population) Placebo+MTX MabThera+MTX 2 × 1000 mg
Under behandlingsforløbet med MabThera subkutan formulering, bør andre lægemidler til subkutan administration så vidt muligt gives andre steder. 
During the treatment course with MabThera subcutaneous formulation, other medicinal products for subcutaneous administration should preferably be given at different sites.
µg.dag/ml 
µg.day/mL
Hvis du får MabThera sammen med anden medicin, kan nogle bivirkninger være forårsaget af den anden medicin. 
If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.
Informationen i dette afsnit relaterer sig til onkologisk brug af MabThera. 
The information provided in this section pertains to the use of MabThera in oncology.
Disse ændringer inkluderer nedsat indhold af nogle specifikke proteiner i blodet (immunglobuliner), som hjælper med at beskytte mod infektioner 
These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection.
Du må ikke få MabThera, hvis: 
Do not take MabThera if:
Afslutning af 4. kvartal 2019 (foreløbig CSR) Afslutning af 4. kvartal 2020 (endelig CSR) 
by Q4 2019 (preliminary CSR) by Q4 2020 (final CSR)
R-CHOP var associeret med bedre udfald for både høj- og lavrisikopatienter i forhold til aldersjusteret IPI. 
R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI.
ACR20 ACR50 ACR70 EULAR respons (god/moderat) Gennemsnitsændring i DAS 
ACR20 ACR50 ACR70 EULAR Response (Good/Moderate) Mean Change in DAS
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. 
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.