natgillin/translations-raw huggingface dataset:
Der er ikke foretaget undersøgelser af MabTheras indflydelse på evnen til at føre bil eller betjene maskiner, selvom den farmakologiske virkning og de indtil dato rapporterede bivirkninger ikke antyder, at en sådan virkning er sandsynlig.
No studies on the effects of MabThera on the ability to drive and use machines have been performed, although the pharmacological activity and adverse events reported to date do not indicate that such an effect is likely.
Erfaringer fra non- Hodgkin lymfom og kronisk lymfatisk leukæmi
Experience from non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia.
MabThera’ s sikkerhedsprofil ved non- Hodgkin lymfom og kronisk lymfatisk leukæmi er baseret på data fra patienter fra kliniske studier og fra post- marketing overvågning.
The overall safety profile of MabThera in non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia is based on data from patients from clinical trials and from post-marketing surveillance.
Incidensen af infusionsrelaterede symptomer aftager væsentligt med de følgende infusioner og er under 1% efter 8 doser MabThera.
The incidence of infusion-related symptoms decreases substantially with subsequent infusions and is less than 1% after eight doses of MabThera.
30- 55% af patienterne i de kliniske studier hos patienter med NHL samt hos 30- 50% af patienterne i de kliniske studier med CLL.
Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trial in patients with CLL
4. 4. • Kardiovaskulære hændelser, se pkt 4. 4.
The most frequent reported or observed serious adverse drug reactions were: • Infusion-related reactions (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4. • Infections, see section 4.4. • Cardiovascular events, see section 4.4.
4. 4.)
Other serious ADRs reported include hepatitis B reactivation and PML (see section 4.4.)
Hyppigheden af de bivirkninger, som er rapporteret ved MabThera alene eller i kombination med kemoterapi er sammenfattet i de følgende tabeller.
The frequencies of ADRs reported with MabThera alone or in combination with chemotherapy are summarised in the tables below.
Inden for hver hyppighedsgruppe er bivirkningerne anført efter aftagende sværhedsgrad.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Hyppigheden defineres som meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 til < 1/ 10), ikke almindelig (≥ 1/ 1. 000 til < 1/ 100) og sjælden (≥ 1/ 10. 000 til < 1/ 1000).
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100) and rare (≥ 1/ 10,000 to < 1/ 1000).
De bivirkninger, som kun er set under post- marketing overvågning, og for hvilke, der ikke kunne beregnes en hyppighed er anført under ” ukendt ”.
The ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “ unknown”.
10 Tabel 1
Table 1
Sammenfatning af bivirkninger, som blev rapporteret i kliniske studier eller under post marketing overvågning, hos patienter med NHL og CLL, som fik MabThera monoterapi eller vedligeholdelsesbehandling med MabThera, eller i kombination med kemoterapi
ADRs reported in clinical trials or during postmarketing surveillance in patients with NHL and CLL disease treated with MabThera monotherapy/ maintenance or in combination with chemotherapy
Meget
System Organ
System- organklasse
Very
Almindelig +
Uncommon
Ualmindelig
Unknown
bakterielle og
bacterial
sepsis, pneumoni, +
sepsis, +
alvorlig
pneumonia, +
parasitære
infection1,
virale
viral
febril infektion, +
febrile infection, +
virusinfektion1,
hepatitis B
sygdomme
infections, + bronchitis
infektioner +
reactivation1
herpes zoster, +
System Organ
reaktivering af
Common
bronkitis
Uncommon
luftvejsinfektioner, svampeinfektioner, infektioner af ukendt ætiologi, + akut bronkitis, + sinusitis
Unknown
hepatitis B 1
Class
Blod og lymfesystem
Common
neutropeni, leukopeni, +
Blood and lymphatic system disorders
anæmi, trombocytopeni,
neutropenia, anaemia, leucopenia, thrombocytopenia, +febrile +
koagulationssyg - domme,
coagulation disorders, aplastic anaemia,
sen neutropeni2, forbigående
Late neutropenia2, transient increase
febril neutropeni
pancytopenia neutropenia
aplastisk anæmi, hæmolytisk anæmi, lymfadenopati
haemolytic anaemia, lymphadenopathy
stigning i koncentrationen af serum IgM2
in serum IgM levels2
infusions - relaterede reaktioner, angioødem
infusion hypersensitivity related reactions, angioedema
tumorlysesyn - drom3, cytokin frigivelses - syndrom3, serumsygdom, anafylaksi
tumour lysis syndrome3, cytokine release syndrome3, serum sickness, anaphylaxis
hyperglykæmi, vægttab, perifert ødem, ansigtsødem, øget LDH, hypocalcæmi
hyperglycaemia, weight decrease, peripheral oedema, face
Psykiske forstyrrelser
oedema, increased LDH, hypocalcaemia Psychiatric disorders
paræstesi, hypoæstesi, agitation, insomni, vasodilatation, svimmelhed, angst
paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety
kraniel neuropati, perifer neuropati facialisparese4, tab af andre sanser4
cranial neuropathy, peripheral neuropathy facial nerve palsy4, loss of other senses4
svær synstab4
severe vision loss4
tinnitus, øresmerter +
tinnitus, ear pain
tab af hørelse4
hearing loss4
Hjerte
+
myokardieinfarkt3 og 5
+
+ venstre
Cardiac disorders
hjertestop3 og 5,
myocardial infarction3 and 5,
, arytmier, +
left ventricular failure, + supraventricular
ventrikulært
heart failure3 and 5, severe cardiac
svære kardiale
arrhythmia, +atrial
atrieflimren,
tachycardia, +
svigt, +
events 3 and 5
hændelser 3 og 5
fibrillation, tachycardia, + cardiac disorder
takykardi, +
Vascular disorders
supraventriku -
hypertension, orthostatic hypotension, hypotension
hjertesygdom
Respiratory, thoracic and mediastinal disorders
lær takykardi, + ventrikulær takykardi, + angina, + myokardie - iskæmi, bradykardi,
bronchospasm3, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis
11 Meget
11
System- organklasse
System Organ
Ukendt
Class
Vaskulære sygdomme
Common
opkastning, diarre, mavesmerter, dysfagi, stomatitis, obstipation, dyspepsi, anoreksi, halsirritation
vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation
gastro- intestinal perforation6
gastro-intestinal perforation6
pruritis, udslæt, +
pruritis, rash, +
urticaria, svedtendens,
urticaria, sweating, night
svære bulløse hudreaktioner,
severe bullous skin reactions,
alopeci
tissue disorders Musculoskeletal, connective tissue and bone disorders
nattesved, +
alopecia
hudsygdomme hypertoni, myalgier, artralgier, rygsmerter, nakkesmerter, smerter
sweats, +skin disorder hypertonia, myalgia, arthralgia, back pain, neck pain, pain
nekrolyse6
toxic epidermal necrolysis6
Nyre - og urinveje
Renal and urinary disorders
nyresvigt3
renal failure3
Almene symptomer
General disorders and administration
tumorsmerter,
fever, chills, asthenia,
smerter på
tumour pain, flushing, malaise, cold syndrome, +
og reaktioner på administrationsstedet
pain at the infusion site
kulderystel - ser, asteni, hovedpine
site conditions
hedeture, utilpashed, kuldesyndrom, + træthed, + kulderystelser, + multiorgansvigt3
headache
infusionsstedet
fatigue, + shivering, + multi-organ failure3
nedsat koncentration af IgG
decreased IgG levels
Hyppigheden var baseret på alle bivirkninger, uanset sværhedsgrad (fra lette til alvorlige bivirkninger), bortset fra bivirkninger, som er markeret med “ + ”, hvor hyppigheden kun er baseret på alvorlige bivirkninger (NCI common toxicity criteria ≥ grad 3).
For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+" where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
1 se også afsnittet om infektioner herunder 2 se også afsnittet om hæmatologiske bivirkninger herunder 3 se også afsnittet om infusionsrelaterede reaktioner herunder.
Only the highest frequency observed in the trials is reported 1 see also section infection below 2 see also section haematologic adverse reactions below 3 see also section infusion-related reactions below.
Der er beskrevet sjældne tilfælde med dødelig udgang.
Rarely fatal cases reported 4 signs and symptoms of cranial neuropathy.
Forekom på forskellige tidspunkter op til flere måneder efter afslutningen af behandlingen med MabThera 5 Fortrinsvis set hos patienter med tidligere hjertesygdom og/ eller kardiotoksisk kemoterapi.
Occurred at various times up to several months after completion of MabThera therapy 5 observed mainly in patients with prior cardiac condition and/ or cardiotoxic chemotherapy and were mostly associated with infusion-related reactions 6 includes fatal cases
Følgende reaktioner blev indberettet som bivirkninger under de kliniske studier, men blev rapporteret med samme eller lavere hyppighed i MabThera- armen, sammenlignet med kontrolarmene: hæmatotoksicitet, infektioner hos neutropene patienter, urinvejsinfektioner, sensoriske forstyrrelser og pyreksi.
The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the MabThera-arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
De optrådte fortrinsvis under den første infusion, normalt under de første én til to timer.
Infusion-related reactions Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of patients in clinical trials, and were predominantly seen during the first infusion, usually in the first one to two hours.
Andre symptomer omfattede hedeture, angioødem, bronkospasmer, opkastning, kvalme, urticaria/ nældefeber, træthed, hovedpine, halsirritation, rhinitis, pruritus, smerter, takykardi, hypertension, hypotension, dyspnø, dyspepsi, asteni og tegn på tumorlysesyndrom.
Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/ rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumor lysis syndrome.
Der forekom svære infusionsrelaterede reaktioner (som fx bronkospasmer eller hypotension) i ca.
Severe infusion-related reactions (such as bronchospasm, hypotension) occurred in about 10% of the cases.
I nogle tilfælde blev der også rapporteret om myokardieinfarkt, atrieflimren og lungeødem.
Additional reactions reported in some cases were myocardial infarction, atrial fibrillation and pulmonary oedema.
Exacerbationer af hjertelidelser som angina pectoris, kongestiv hjertesygdom eller svære hjertetilfælde (hjertestop, myokardieinfarkt og atrieflimren), lungeødem, multiorgansvigt, tumorlysesyndrom, cytokin frigivelsessyndrom, nyresvigt og respirationssvigt blev rapporteret med lavere eller ukendt hyppighed.
12 events (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
Hyppigheden af infusionsrelaterede bivirkninger aftog væsentligt med de efterfølgende infusioner og var under 1% efter den ottende behandlingsserie med MabThera.
The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is < 1% of patients by the eighth cycle of MabThera(-containing) treatment.
Infektioner MabThera inducerede B- cellereduktion hos 70% til 80% af patienterne, men blev kun ledsaget af nedsat serum- immunglobulin hos en mindre del af patienterne.
Infections MabThera induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
I de randomiserede studier var hyppigheden af lokale candidainfektioner og herpes zoster højere i den arm, som indeholdt MabThera.
Localized candida infections as well as Herpes zoster was reported at a higher incidence in the MabThera-containing arm of randomized studies.
4% af tilfældene.
Severe infections were reported in about 4% of patients.
Der blev ikke rapporteret om kumulativ toksicitet med hensyn til infektioner i en behandlingsperiode på 2 år.
Higher frequencies of infections overall, including grade 3 or 4 infections, were observed during MabThera maintenance treatment up to 2 years when compared to observation. There was no cumulative toxicity in terms of infections reported over a 2-year treatment period.
Heraf var nogle fatale.
In addition, other serious viral infections either new, reactivated or exacerbated, some of which were fatal, have been reported with MabThera treatment.
De fleste patienter fik MabThera i kombination med med kemoterapi eller som en del af en hæmatopoietisk stamcelletransplantation.
The majority of patients had received MabThera in combination with chemotherapy or as part of a hematopoetic stem cell transplant.
Der er rapporteret om tilfælde af reaktivering af hepatitis B, hvoraf de fleste forekom hos patienter, som fik MabThera i kombination med cytotoksisk kemoterapi.
Cases of hepatitis B reactivation, have been reported, the majority of which were in subjects receiving MabThera in combination with cytotoxic chemotherapy.
Der er observeret progression af Kaposis sarkom hos rituximab- eksponerede patienter med Kaposis sarkom.
Progression of Kaposi’ s sarcoma has been observed in rituximab-exposed patients with pre-existing Kaposi’ s sarcoma.
Disse tilfælde forekom hos ikke- godkendte indikationer, og de fleste patienter var HIV- positive.
These cases occurred in non-approved indications and the majority of patients were HIV positive.
Hæmatologiske bivirkninger I de kliniske studier med MabThera monoterapi forekom hæmatologiske bivirkninger hos en minoritet af patienterne og var sædvanligvis lette og reversible.
Haematologic Adverse Reactions In clinical trials with MabThera monotherapy given for 4 weeks, haematological abnormalities occurred in a minority of patients and were usually mild and reversible.
Svær (grad 3 og 4) neutropeni forekom hos 4, 2% af patienterne, svær anæmi hos 1, 1%, og svær trombocytopeni hos 1, 7%.
Severe (grade 3/ 4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Under vedligeholdelsesbehandling med MabThera i op til 2 år blev der rapporteret om højere hyppighed end i observationsgruppen af leukopeni (5% versus 2%, grad 3/ 4) og neutropeni (10% versus 4%, grad 3/ 4).
4%, grade 3/ 4) were reported at a higher incidence when compared to observation.
Hyppigheden af trombocytopeni var lav (< 1, grad 3/ 4), og der var ingen forskel mellem behandlingsarmene.
The incidence of thrombocytopenia was low (< 1, grade 3/ 4%) and was not different between treatment arms.
I studier med MabThera i kombination med kemoterapi blev der rapporteret hyppigere om leukopeni grad 3/ 4 (R- CHOP 88% vs CHOP 79%, R- FC 23% vs FC 12%), neutropeni (R- CVP 24% vs CVP 14%; R- CHOP 97% vs CHOP 88%, R- FC 30% vs.
CHOP 79%, R-FC 23% vs.
FC 19%), pancytopeni (R- FC 3% vs FC 1%) sammenlignet med kemoterapi alene.
CHOP 88%, R-FC 30% vs.
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, og neutropenien var ikke forlænget i MabThera- gruppen.
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 and the neutropenia was not prolonged in the MabThera group.
Der blev ikke rapporteret om forskelle i hyppigheden af trombocytopeni eller anæmi.
There were no differences reported for the incidence of thrombocytopenia or anaemia.
Der blev rapporteret om nogle tilfælde af sen neutropeni, som indtraf mere end fire uger efter den sidste infusion med MabThera.
Some cases of late neutropenia occurring more than four weeks after the last infusion of MabThera were reported.
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.
De hyppigst rapporterede bivirkninger var hypotension og hypertension.
Cardiovascular reactions Cardiovascular reactions during clinical trials with MabThera monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Under vedligeholdelsesbehandlingen var hyppigheden af hjertesygdomme af grad 3/ 4 / sammenlignelig mellem patienter behandlet i MabThera- gruppen og i observationssgruppen.
During maintenance treatment, the incidence of grade 3/ 4 cardiac disorders was comparable between patients treated with MabThera and observation.
Kardiale hændelser (herunder atrieflimren, myokardieinfarkt, venstre ventrikulært svigt og myokardieiskæmi) blev rapporteret som alvorlige bivirkninger hos 3% af patienterne, som fik MabThera sammenlignet med < 1% i observationsgruppen.
In studies evaluating MabThera in combination with chemotherapy, the incidence of
I studier, som evaluerede MabThera i kombination med kemoterapi var hyppigheden af arytmier af grad 3 og 4, fortrinsvis supraventrikulære arytmier, som fx takykardi og atrieflagren/ atrieflimren, højere i R- CHOP- gruppen (14 patienter, 6, 9%) sammenlignet med CHOP- gruppen (3 patienter, 1, 5%).
13 grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/ fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Alle arytmier indtraf enten sammen med infusion af MabThera eller havde relation til en prædisponerende tilstand som fx feber, infektion, akut myokardieinfarkt eller præeksisterende respiratorisk eller kardiovaskulær sygdom.
All of these arrhythmias either occurred in the context of a MabThera infusion or were associated with predisposing conditions such as fever, infection, acute myocardial infarction or pre-existing respiratory and cardiovascular disease.
Der blev ikke set forskelle mellem R - CHOP - og CHOP- grupperne med hensyn til andre kardiale hændelser af grad 3 og 4, herunder hjertestop, myokardiesygdom og manifestationer af koronar arteriesygdom.
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.
I CLL 1. linie studiet var incidensen af hjertesygdomme af grad 3 eller 4 lav (4% R- FC, 3% FC).
In the CLL first-line study, the overall incidence of grade 3 or 4 cardiac disorders was low (4% R-FC, 3% FC).
Neurologiske hændelser I behandlingsperioden fik fire patienter (2%) i R- CHOP- armen, alle med kardiovaskulære risikofaktorer, tromboemboliske cerebrovaskulære hændelser i den første behandlingsserie.
Neurologic events During the treatment period, four patients (2%) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Derimod fik tre patienter (1, 5%) cerebrovaskulære hændelser i CHOP- armen, og alle forekom i follow- up- perioden.
In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
I CLL 1. linie studiet var incidensen af sygdomme fra nervesystemet af grad 3 eller 4 lav (4% R- FC, 4% FC).
In the CLL first-line study, the overall incidence of grade 3 or 4 nervous system disorders was low (4% R-FC, 4% FC).
Gastrointestinale sygdomme Hos patienter, der er behandlet med MabThera for non- Hodgkin lymfom, er der i nogle tilfælde set gastrointestinal perforation og i nogle tilfælde med dødelig udgang.
Gastrointestinal Disorders Gastrointestinal perforation in some cases leading to death has been observed in patients receiving MabThera for treatment of non Hodgkin lymphoma.
IgG niveauer I kliniske forsøg med MabThera som vedligeholdelsesbehandling var de mediane IgG niveauer under nedre referencegrænse (< 7 g/ l) i både observationsgruppen og MabThera- gruppen efter induktionsbehandlingen.
IgG levels In the clinical trial evaluating MabThera maintenance treatment, median IgG levels were below the lower limit of normal (LLN) (< 7 g/ L) after induction treatment in both the observation and the MabThera groups.
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.
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).
Specielle populationer (MabThera monoterapi) Ældre patienter (≥ 65 år):
Patient subpopulations (MabThera monotherapy) Elderly patients(≥ 65 years):
Hyppigheden af bivirkninger, uanset sværhedsgrad, og hyppigheden af grad 3 og 4 bivirkninger var ens hos ældre, sammenlignet med yngre (< 65 år).
The incidence of ADRs of all grades and grade 3 / 4 ADR was similar in elderly patients compared to younger patients (< 65 years).
Udbredt sygdom Patienter med udbredt sygdom havde en højere hyppighed af grad 3 og 4 bivirkninger end patienter uden udbredt sygdom (25, 6% versus 15, 4%).
Bulky disease There was a higher incidence of grade 3/ 4 ADRs in patients with bulky disease than in patients without bulky disease (25.6% vs.
Genbehandling Andelen af patienter, der rapporterede alle bivirkninger og bivirkninger af grad 3 og 4, efter genbehandling med flere MabThera serier var sammenlignelig med andelen af patienter, der rapporterede bivirkninger efter induktionsbehandling (alle bivirkninger og bivirkninger af grad 3 og 4)
Re-treatment 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).
14 Erfaringer med reumatoid arthritis
Experience from rheumatoid arthritis
Den samlede sikkerhedsprofil for MabThera til behandling af reumatoid arthritis stammer fra data fra kliniske forsøg og fra post- marketing observationer.
The overall safety profile of MabThera in rheumatoid arthritis is based on data from patients from clinical trials and from post-marketing surveillance.
Den kliniske effekt af MabThera i kombination med methotrexat blev undersøgt i tre dobbeltblindede, kontrollerede kliniske forsøg (et fase- III, to fase- II forsøg) hos patienter med reumatoid arthritis.
The clinical efficacy of MabThera, given together with methotrexate was studied in three double blind controlled clinical trials (one phase III two phase II trials) in patients with rheumatoid arthritis.
Næsten 600 patienter gennemgik to eller flere behandlingsforløb i opfølgningsperioden.
More than 1000 patients received at least one treatment course and were followed for periods ranging from 6 months to over 3 years; nearly 600 patients received two or more courses of treatment during the follow up period.
Patienterne fik 2 x 1000 mg MabThera med to ugers interval, derudover methotrexat (10- 25 mg/ uge).
14 Patients received 2 x 1000 mg of MabThera separated by an interval of two weeks; in addition to methotrexate (10-25 mg/ week).
Patienterne blev også behandlet med oral prednison i 15 dage.
MabThera infusions were administered after an intravenous infusion of 100 mg methylprednisolone; patients also received treatment with oral prednisone for 15 days.