natgillin/translations-raw huggingface dataset:
I studierne rapporteredes leukopeni grad 3/4 (R-CHOP 88 % versus CHOP 79 %, R-FC 23 % versus FC 12 %), grad 3/4 neutropeni (R-CVP 24 % versus CVP 14 %; R-CHOP 97 % versus CHOP 88 %, R-FC 30 % versus FC 19 % hos tidligere ubehandlede CLL-patienter), pancytopeni grad 3/4 (R-FC 3 % versus FC 1 % hos tidligere ubehandlede CLL-patienter) sædvanligvis hyppigere under behandlingsforløb med MabThera i kombination med kemoterapi end ved kemoterapi alene.
During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopoenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), grade 3/4 neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), grade 3/4 pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
MabThera 500 mg koncentrat til infusionsvæske, opløsning Hver ml indeholder 10 mg rituximab.
MabThera 500 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
I studierne rapporteredes leukopeni grad 3/4 (R-CHOP 88 % versus CHOP 79 %), neutropeni (R-CVP 24 % versus CVP 14 %; R-CHOP 97 % versus CHOP 88 %) sædvanligvis hyppigere under behandlingsforløb med MabThera i kombination med kemoterapi end ved kemoterapi alene.
During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopoenia (R-CHOP 88% vs. CHOP 79%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%), were usually reported with higher frequencies when compared to chemotherapy alone.
Almene symptomer og reaktioner på administrationsste det feber, kulderystelser, asteni, hovedpine tumorsmerter, hedeture, utilpashed, kuldesyndrom, +træthed, +kulderystelser, +multiorgansvigt4
General disorders and administration site conditions fever , chills, asthenia, headache tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering, +multi-organ failure4
SC til non-Hodgkin-lymfom
SC for Non-Hodgkin's Lymphoma
Efter den femte 500 mg/m2 infusion var den gennemsnitlige Cmax (N=15) 408 µg/ml (spændvidde 97 - 764 µg/ml), og den gennemsnitlige terminale halveringstid var 32 dage (spændvidde 14 - 62 dage).
The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2
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 (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
Efter den anden infusion var gennemsnittet for Cmax 270 µg/ml for doseringen på 2 x 500 mg og varierede fra 377 til 386 µg/ml for doseringen på 2 x 1.000 mg.
Cmax following second infusion, was 207 µg/mL for the 2 x 500 mg dose and ranged from 377 to 386 µg/mL for the 2 x 1000 mg dose.
MabThera 100 mg koncentrat til infusionsvæske, opløsning Hver ml indeholder 10 mg rituximab.
MabThera 100 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
I et åbent, randomiseret studie blev 322 tidligere ubehandlede patienter med follikulært lymfom randomiseret til enten CVP-kemoterapi (cyklophosphamid 750 mg/m2, vincristin 1,4 mg/m2 op til maksimalt 2 mg på dag 1 og prednisolon 40 mg/m2 på dag 1-5) hver 3. uge i 8 serier eller til MabThera 375 mg/m2 i kombination med CVP (R-CVP).
In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1 -5) every 3 weeks for 8 cycles or MabThera 375 mg/m2 in combination with CVP (R-CVP).
Bivirkninger rapporteret ved brug af MabThera subkutan formulering
Adverse reactions reported in MabThera subcutaneous formulation usage
For at nedsætte risikoen for tumorlyse syndrom hos CLL-patienter, anbefales det at give profylakse med tilstrækkelig hydrering og administration af urikosurika 48 timer før behandlingens start.
Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome.
I et klinisk studie blev 99 patienter behandlet med MabThera (375 mg/m2, én gang ugentligt i 4 uger) og glukokortikoider for induktion af remission af GPA og MPA (se pkt.
Ninety-nine patients were treated for induction of remission of GPA and MPA in a clinical trial with MabThera (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Der er observeret et mindre antal spontane og kasuistiske tilfælde af hypogammaglobulinæmi hos pædiatriske patienter behandlet med MabThera.
A small number of spontaneous and literature cases of hypogammaglobulinaemia have been observed in paediatric patients treated with MabThera, in some cases severe and requiring long-term immunoglobulin substitution therapy.
Sikkerheden af sekventiel brug af andre DMARDs (inklusive TNF-inhibitorer og andre biologiske lægemidler) efter behandling med MabThera er kun undersøgt i begrænset omfang i kliniske studier og kan ikke vurderes fuldstændigt (se pkt.
There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following MabThera (see section 4.5).
Tabel 3 Behandling af relaps/refraktær kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for MabThera plus FC versus FC alene (median observationstid: 25,3 måneder)
Table 3 Treatment of relapsed/refractory chronic lymphocytic leukaemia -overview of efficacy results for MabThera plus FC vs. FC alone (25.3 months median observation time) Efficacy Parameter
Efter første infusion varierede gennemsnittet for Cmax for serum-rituximab fra 157 til 171 µg/ml for doseringen på 2 x 500 mg og fra 298 til 341 µg/ml for doseringen på 2 x 1.000 mg.
Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 µg/mL for 2 x 500 mg dose and ranged from 298 to 341 µg/mL for 2 x 1000 mg dose.
Hovedparten af patienterne havde fået rituximab i kombination med kemoterapi eller som led i en hæmatopoietisk stamcelletransplantation.
The majority of patients had received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Derfor bør risikoen for, at infusionen kan føre til kardiovaskulære komplikationer, overvejes før behandling med MabThera hos patienter med kendte hjerteproblemer i anamnesen og hos patienter, som tidligere har oplevet kardiopulmonære bivirkninger.
Therefore, in patients with a known cardiac history, and those who experienced prior cardiopulmonary adverse reactions, the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with MabThera and patients closely monitored during administration.
Tabel 2a Førstelinjebehandling af kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for MabThera plus FC versus FC alene - median observationstid: 48,1 måneder
Table 2a First--line treatment of chronic lymphocytic leukaemia Overview of efficacy results for MabThera plus FC vs. FC alone - 48.1 months median observation time Efficacy Parameter
(hypertension, kvalme, udslæt, pyreksi, kløe, urticaria, halsirritation, hedeture, hypotension, rhinitis, kulderystelser, takykardi, træthed, orofaryngeale smerter, perifert ødem, erytem)
3Infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythema)
I et åbent, randomiseret studie fik 399 tidligere ubehandlede, ældre patienter (60 - 80 år) med diffust storcellet B-celle lymfom standard-CHOP kemoterapi (cyklophosphamid 750 mg/m2, doxorubicin 50 mg/m2, vinkristin 1,4 mg/m op til maksimalt 2 mg på dag 1 og prednison 40 mg/m på dag 1-5) hver 3. uge i 8 serier eller MabThera 375 mg/m2 plus CHOP (R-CHOP).
In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or MabThera 375 mg/m2 plus
I studier blev der under behandlingsforløbet sædvanligvis rapporteret hyppigere om leukopeni grad 3/4 (R-CHOP 88 % versus CHOP 79 %, R-FC 23 % versus FC 12 %), neutropeni (R-CVP 24 % versus CVP 14 %; R-CHOP 97 % versus CHOP 88 %, R-FC 30 % versus FC 19 % ved tidligere ubehandlet CLL), pancytopeni (R-FC 3 % versus FC 1 % ved tidligere ubehandlet CLL) ved MabThera i kombination med kemoterapi end ved kemoterapi alene.
During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with higher frequencies when compared to chemotherapy alone.
Infusionsrelaterede reaktioner hos patienter med GPA, MPA og PV var i overensstemmelse med dem, der sås i kliniske studier med patienter med reumatoid artrit (se pkt.
IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with those seen for rheumatoid arthritis patients in clinical trials (see section
Tilfælde af hepatitis B-reaktivering, herunder letale tilfælde, er rapporteret hos patienter med reumatoid artrit, GPA og MPA, som fik MabThera.
Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving MabThera.
I løbet af perioden mellem uge 24 og uge 56 blev 81 % af de oprindelige placebopatienter behandlet med MabThera.
During this time, 81% of patients, from the original placebo group received MabThera between weeks 24 and 56, under an open label extension study protocol.
Vedligeholdelsesbehandling med MabThera gav en klinisk relevant og statistisk signifikant forbedring af det primære endpoint, PFS (tiden fra vedligeholdelsesrandomiseringen til relaps, sygdomsprogression eller død) sammenlignet med observation alene (p< 0,0001 log rank test).
Maintenance treatment with MabThera led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p< 0.0001 log-rank test).The median PFS was 42.2 months in the MabThera maintenance arm compared to 14.3 months in the observation arm.
Efter første infusion varierede gennemsnittet for Cmax for serum-rituximab fra 170 til 175 µg/ml for doseringen på 2 x 500 mg og fra 317 til 370 µg/ml for doseringen på 2 x 1.000 mg.
Mean Cmax for serum rituximab following first infusion was 170 to 175 µg/mL for 2 x 500 mg dose and 317 to 370 µg/mL for 2 x 1000 mg dose.
Der var ikke nogen påvirkning af sikkerhed, virkning eller farmakokinetik af MabThera ved tilstedeværelse af anti-rituximab-antistoffer eller anti-rHuPH20antistoffer.
There was no impact of the presence of anti-rituximab or anti-rHuPH20 antibodies on safety, efficacy or PK of MabThera.
Follikulært non-Hodgkin-lymfom
Follicular non-Hodgkin's lymphoma
smerter på infusionsstedet
infusion site pain
Hud og subkutane væv kløe, udslæt, +alopeci urticaria, svedtendens, nattesved, +hudsygdomme svære bulløse hudreaktioner, StevensJohnsons syndrom, toksisk epidermal nekrolyse (Lyells syndrom)7
Skin and subcutaneous tissue disorders pruritus, rash, +alopecia urticaria, sweating, night sweats, +skin disorder severe bullous skin reactions, Stevens-Johns on syndrome toxic epidermal necrolysis (Lyell's syndrome) 7
Tabel 10a Førstelinjebehandling af kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for MabThera plus FC versus FC alene - median observationstid: 48,1 måneder
Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for MabThera plus FC vs. FC alone - 48.1 months median observation time Efficacy Parameter
Geometriske gennemsnitlige
Geometric mean
Det kan være smerter, hævelse, blå mærker, blødning, rødme, kløe og udslæt.
These include: pain, swelling, bruising, bleeding, skin redness, itching and rash.
Patienterne havde en lavere responsrate over for vaccination med tetanus recall antigen (16 % versus 81 %) og Keyhole Limet Haemocyanin (KLH) neoantigen (4 % versus 76 %, når vurderet for > 2-fold stigning i antistof -titeren).
In a non-randomised study, patients with relapsed low-grade NHL who received MabThera monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for >2-fold increase in antibody titer).
Reumatoid artrit, granulomatose med polyangiitis, mikroskopisk polyangiitis og pemfigus vulgaris
Rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris
Tabel 4 Bivirkninger opstået hos ≥ 5 % af patienterne i vedligeholdelsesbehandling med MabThera for granulomatose med polyangiitis (Wegeners granulomatose) og mikroskopisk polyangiitis, og ved en højere frekvens end sammenligningsgruppen.
Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving MabThera for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
MabThera 100 mg koncentrat til infusionsvæske, opløsning MabThera 500 mg koncentrat til infusionsvæske, opløsning rituximab
MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion rituximab
+venstre ventrikel svigt, +supraventrikulær takykardi, +ventrikulæ r takykardi, +angina, +myokardie -iskæmi, bradykardi,
+left ventricular failure, +supraventricu lar tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia disorders 4 and 6 heart failure4
Patienter, som fik MabThera i kombination med methotrexat, udviste i uge 56 signifikant mindre radiologisk progression end patienter, der i starten udelukkende havde fået methotrexat.
In Trial 1, conducted in patients with inadequate response or intolerance to one or more TNF inhibitor therapies, receiving MabThera in combination with methotrexate demonstrated significantly less radiographic progression than patients originally receiving methotrexate alone at 56 weeks.
Mavetarmkanalen kvalme opkastning , diarre, mavesmerter, dysfagi, stomatitis, obstipation, dyspepsi, anoreksi, halsirritation forstørret abdomen gastrointestinal perforation7
Gastrointestin al disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
De geometriske gennemsnits Ctrough (CV %) værdier ved behandlingsserie 5 (før dosering i serie 6) var højere blandt den subkutane MabThera-gruppe end i den intravenøse MabThera-gruppe, henholdsvis 97,5 μg/ml (42,6) versus 61,5 μg/ml (63,9).
Cycle 5 (pre-dose Cycle 6) were higher among the MabThera subcutaneous group than the MabThera intravenous group; 97.5 µg/mL (42.6) versus 61.5 µg/mL (63.9) respectively with a resulting adjusted geometric mean ratio [90% CI] of 1.53 [1.27-1.85].
En efterfølgende analyse af længden af overlevelsen, udført med en median opfølgningsperiode på 60 måneder, bekræftede fordelene ved R-CHOP behandlingen i forhold til CHOP behandlingen (p=0,0071), hvilket svarer til en risikoreduktion på 32 %.
At 24 months, estimates for overall survival were 68.2 % in the R-CHOP arm compared to 57.4 % in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32 %.
Infektioner og parasitære sygdomme Urinvejsinfektion
Infections and Infestations upper respiratory tract infection, urinary tract infections
Resultaterne af forlænget opfølgning af patienterne i studiet (median observationstid 9 år) bekræftede langtidseffekterne af MabThera vedligeholdelsesbehandling i forhold til progressionsfri overlevelse, hændelsesfri overlevelse, tid til næste anti-lymfom-behandling og tid til næste kemoterapibehandling (tabel 4).
Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of MabThera maintenance therapy in terms of PFS, EFS, TNLT and TNCT (Table 4).
Resultaterne af forlænget opfølgning af patienterne i studiet (median observationstid 9 år) bekræftede langtidseffekterne af MabThera vedligeholdelsesbehandling i forhold til progressionsfri overlevelse, hændelsesfri overlevelse, tid til næste anti-lymfom-behandling og tid til næste kemoterapibehandling (tabel 7).
Data from extended follow-up of patients in the study (median follow-up 9 years) confirmed the longterm benefit of MabThera maintenance therapy in terms of PFS, EFS, TNLT and TNCT (Table 7).
Tabel 2 Effektresultater for SABRINA (BO22334) (ITT populationen)
Table 2 Efficacy results for SABRINA (BO22334) (Intent to Treat Population) Pooled Stages 1 & 2 N = 410
Tilfælde af hepatitis B-reaktivering, herunder tilfælde af fulminant hepatitis med dødelig udgang, er rapporteret hos patienter, der har fået MabThera intravenøs formulering.
Cases of hepatitis B reactivation have been reported in patients receiving the MabThera intravenous formulation including fulminant hepatitis with fatal outcome.
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).
where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
I kliniske studier var lokale hudreaktioner meget almindelige hos patienter, der blev behandlet med MabThera subkutan formulering.
Local cutaneous reactions were very common in patients receiving MabThera subcutaneous in clinical trials.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) MabThera 500 mg, koncentrat til infusionsvæske, opløsning Rituximab
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 500 mg concentrate for solution for infusion Rituximab
Samlet responserate a
p-value a
MabThera 1600 mg opløsning til subkutan injektion rituximab
MabThera 1600 mg solution for subcutaneous injection rituximab
Data fra udviklingsprogrammet for den sukutane formulering af MabThera indikerer, at dannelsen af anti-rituximab-antistoffer efter subkutan administration er sammenlignelig med dannelsen efter intravenøs administration I SABRINA-studiet (BO22334) var forekomsten af behandlingsinducerede/forhøjede anti-rituximab-antistoffer lav og sammenlignelig med den intravenøse og subkutane gruppe (henholdsvis 1,9 % versus 2 %).
In the SABRINA trial (BO22334) the incidence of treatment-induced/enhanced anti-rituximab antibodies was low and similar in the intravenous and subcutaneous groups (1.9% vs. 2%, respectively).
MabThera 1400 mg opløsning til subkutan injektion rituximab
MabThera 1400 mg solution for subcutaneous injection rituximab
Til den tid og inden for højst 1 måned efter den sidste cyclophosphamid pulsbehandling blev patienterne randomiseret til at få enten MabThera (to 500 mg intravenøse infusioner med to ugers mellemrum (på dag 1 og dag 15) efterfulgt af 500 mg intravenøst hver 6. måned i 18 måneder) eller azathioprin (administreret oralt i en dosis på 2 mg/kg/dag i 12 måneder, derefter 1,5 mg/kg/dag i 6 måneder og til sidst 1 mg/kg/dag i 4 måneder (behandlingsophør efter disse 22 måneder)).
At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, patients were randomly assigned to receive either MabThera (two 500 mg IV infusions separated by two weeks (on Day 1 and Day 15) followed by 500 mg IV every 6 months for
Patienterne havde en lavere responsrate over for vaccination med tetanus recall antigen (16 % versus 81 %) og Keyhole Limet Haemocyanin (KLH) neoantigen (4 % versus 69 %, når vurderet for > 2-fold stigning i antistof -titer).
In a non-randomized study, patients with relapsed low-grade NHL who received the MabThera intravenous formulation as monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 69% when assessed for >2-fold increase in antibody titer).
4.8) tyder de nuværende data ikke på nogen øget risiko for malignitet.
On the basis of limited experience with MabThera in rheumatoid arthritis patients (see section 4.8) the present data do not seem to suggest any increased risk of malignancy.
Luftveje, thorax og mediastinum bronkospasmer4, luftvejssygdomme, brystsmerter, dyspnø, øget hoste, rhinitis astma, bronchiolitis obliterans, lungesygdomme, hypoksi interstitiel lungesygdom7
Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
4.3) eller til alvorligt immunkompromitterede patienter (for eksempel hvor CD4- eller CD8-niveauerne er meget lave).
MabThera should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
MabThera subkutan formulering blev administreret til tidligere ubehandlede FL-patienter i en fast subkutan dosis på 1400 mg i 6 behandlingsserier, og i kombination med kemoterapi, med 3 ugers mellemrum under induktionen, efter første behandlingsserie med MabThera var givet i intravenøs formulering.
MabThera subcutaneous formulation at a fixed dose of 1400 mg was administered for 6 cycles subcutaneously during induction at 3-weekly intervals, following the first cycle of MabThera intravenous formulation, in previously untreated FL patients in combination with chemotherapy.
MabThera subkutan formulering blev administreret til tidligere ubehandlede CLL-patienter i en fast subkutan dosis på 1600 mg i 5 behandlingsserier, og i kombination med kemoterapi (fludarabin og cyklofosfamid (FC)), med 4 ugers mellemrum, efter at den første behandlingsserie med MabThera var givet i intravenøs formulering.
MabThera at a fixed dose of 1600 mg was administered for 5 cycles subcutaneously at 4-weekly intervals, following the first cycle of MabThera intravenous formulation, in previously untreated CLL patients in combination with chemotherapy (fludarabine and cyclophosphamide (FC).
Kemoterapi skal gives efter at MabThera er givet.
The chemotherapy should be given after MabThera administration.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) MabThera 100 mg, koncentrat til infusionsvæske, opløsning Rituximab
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 100 mg concentrate for solution for infusion Rituximab
De fleste patienter fik MabThera i kombination 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 hematopoietic stem cell transplant.
Der har været rapporteret om svære hudreaktioner som toksisk epidermal nekrolyse (Lyells syndrom) og Stevens-Johnson syndrom, nogle med dødelig udgang (se pkt.
Severe skin reactions such as Toxic Epidermal Necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported (see section 4.8).
Ualmindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter):
Uncommon side effects (may affect up to 1 in 100 people):