FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Danish: 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).
English: 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.
Danish: 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.
English: MabThera 100 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
Danish: MabThera 100 mg koncentrat til infusionsvæske, opløsning Hver ml indeholder 10 mg rituximab.
English: 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).
Danish: 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).
English: Adverse reactions reported in MabThera subcutaneous formulation usage
Danish: Bivirkninger rapporteret ved brug af MabThera subkutan formulering
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: 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.
Danish: Der er observeret et mindre antal spontane og kasuistiske tilfælde af hypogammaglobulinæmi hos pædiatriske patienter behandlet med MabThera.
English: 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).
Danish: 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.
English: 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
Danish: 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)
English: 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.
Danish: 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.
English: The majority of patients had received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Danish: Hovedparten af patienterne havde fået rituximab i kombination med kemoterapi eller som led i en hæmatopoietisk stamcelletransplantation.
English: 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.
Danish: 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.
English: 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
Danish: Tabel 2a Førstelinjebehandling af kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for MabThera plus FC versus FC alene - median observationstid: 48,1 måneder
English: 3Infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythema)
Danish: (hypertension, kvalme, udslæt, pyreksi, kløe, urticaria, halsirritation, hedeture, hypotension, rhinitis, kulderystelser, takykardi, træthed, orofaryngeale smerter, perifert ødem, erytem)
English: 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
Danish: 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).
English: 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.
Danish: 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.
English: 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
Danish: 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.
English: 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.
Danish: Tilfælde af hepatitis B-reaktivering, herunder letale tilfælde, er rapporteret hos patienter med reumatoid artrit, GPA og MPA, som fik MabThera.
English: 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.
Danish: I løbet af perioden mellem uge 24 og uge 56 blev 81 % af de oprindelige placebopatienter behandlet med MabThera.
English: 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.
Danish: 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).
English: 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.
Danish: 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.
English: There was no impact of the presence of anti-rituximab or anti-rHuPH20 antibodies on safety, efficacy or PK of MabThera.
Danish: Der var ikke nogen påvirkning af sikkerhed, virkning eller farmakokinetik af MabThera ved tilstedeværelse af anti-rituximab-antistoffer eller anti-rHuPH20antistoffer.
English: Follicular non-Hodgkin's lymphoma
Danish: Follikulært non-Hodgkin-lymfom
English: infusion site pain
Danish: smerter på infusionsstedet
English: 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
Danish: Hud og subkutane væv kløe, udslæt, +alopeci urticaria, svedtendens, nattesved, +hudsygdomme svære bulløse hudreaktioner, StevensJohnsons syndrom, toksisk epidermal nekrolyse (Lyells syndrom)7
English: 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
Danish: Tabel 10a Førstelinjebehandling af kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for MabThera plus FC versus FC alene - median observationstid: 48,1 måneder
English: Geometric mean
Danish: Geometriske gennemsnitlige
English: These include: pain, swelling, bruising, bleeding, skin redness, itching and rash.
Danish: Det kan være smerter, hævelse, blå mærker, blødning, rødme, kløe og udslæt.
English: 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).
Danish: 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).
English: Rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris
Danish: Reumatoid artrit, granulomatose med polyangiitis, mikroskopisk polyangiitis og pemfigus vulgaris
English: 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
Danish: 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.
English: MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion rituximab
Danish: MabThera 100 mg koncentrat til infusionsvæske, opløsning MabThera 500 mg koncentrat til infusionsvæske, opløsning rituximab
English: +left ventricular failure, +supraventricu lar tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia disorders 4 and 6 heart failure4
Danish: +venstre ventrikel svigt, +supraventrikulær takykardi, +ventrikulæ r takykardi, +angina, +myokardie -iskæmi, bradykardi,
English: 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.
Danish: 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.
English: Gastrointestin al disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7
Danish: Mavetarmkanalen kvalme opkastning , diarre, mavesmerter, dysfagi, stomatitis, obstipation, dyspepsi, anoreksi, halsirritation forstørret abdomen gastrointestinal perforation7
English: 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].
Danish: 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).
English: 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 %.
Danish: 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 %.
English: Infections and Infestations upper respiratory tract infection, urinary tract infections
Danish: Infektioner og parasitære sygdomme Urinvejsinfektion
English: MabThera 1600 mg Rituximab
Danish: MabThera 1600 mg
English: 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).
Danish: 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).
English: 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).
Danish: 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).
English: Table 2 Efficacy results for SABRINA (BO22334) (Intent to Treat Population) Pooled Stages 1 & 2 N = 410
Danish: Tabel 2 Effektresultater for SABRINA (BO22334) (ITT populationen)
English: Cases of hepatitis B reactivation have been reported in patients receiving the MabThera intravenous formulation including fulminant hepatitis with fatal outcome.
Danish: Tilfælde af hepatitis B-reaktivering, herunder tilfælde af fulminant hepatitis med dødelig udgang, er rapporteret hos patienter, der har fået MabThera intravenøs formulering.
English: where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
Danish: 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).
English: Local cutaneous reactions were very common in patients receiving MabThera subcutaneous in clinical trials.
Danish: I kliniske studier var lokale hudreaktioner meget almindelige hos patienter, der blev behandlet med MabThera subkutan formulering.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 500 mg concentrate for solution for infusion Rituximab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) MabThera 500 mg, koncentrat til infusionsvæske, opløsning Rituximab
English: p-value a
Danish: Samlet responserate a
English: MabThera 1600 mg solution for subcutaneous injection rituximab
Danish: MabThera 1600 mg opløsning til subkutan injektion rituximab
English: 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).
Danish: 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 %).
English: MabThera 1400 mg solution for subcutaneous injection rituximab
Danish: MabThera 1400 mg opløsning til subkutan injektion rituximab
English: 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
Danish: 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)).
English: 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).
Danish: 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).
English: 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.
Danish: 4.8) tyder de nuværende data ikke på nogen øget risiko for malignitet.
English: Bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7
Danish: Luftveje, thorax og mediastinum bronkospasmer4, luftvejssygdomme, brystsmerter, dyspnø, øget hoste, rhinitis astma, bronchiolitis obliterans, lungesygdomme, hypoksi interstitiel lungesygdom7
English: 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).
Danish: 4.3) eller til alvorligt immunkompromitterede patienter (for eksempel hvor CD4- eller CD8-niveauerne er meget lave).
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: The chemotherapy should be given after MabThera administration.
Danish: Kemoterapi skal gives efter at MabThera er givet.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 100 mg concentrate for solution for infusion Rituximab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) MabThera 100 mg, koncentrat til infusionsvæske, opløsning Rituximab
English: The majority of patients had received MabThera in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Danish: De fleste patienter fik MabThera i kombination med kemoterapi eller som en del af en hæmatopoietisk stamcelletransplantation.
English: 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).
Danish: Der har været rapporteret om svære hudreaktioner som toksisk epidermal nekrolyse (Lyells syndrom) og Stevens-Johnson syndrom, nogle med dødelig udgang (se pkt.
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ualmindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter):
English: NAME OF THE MEDICINAL PRODUCT MabThera 1600 mg solution for subcutaneous injection
Danish: LÆGEMIDLETS NAVN MabThera 1600 mg opløsning til subkutan injektion
English: Clinical experience of MabThera concentrate for solution for infusion in CLL
Danish: Klinisk erfaring med MabThera koncentrat til opløsning til infusion ved kronisk lymfatisk leukæmi
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with follicular lymphoma.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med rituximab i alle undergrupper af den pædiatriske population med kronisk lymfatisk leukæmi.
English: NAME OF THE MEDICINAL PRODUCT MabThera 1400 mg solution for subcutaneous injection
Danish: LÆGEMIDLETS NAVN MabThera 1400 mg opløsning til subkutan injektion
English: What MabThera 1400 mg solution for subcutaneous injection contains
Danish: MabThera 1400 mg opløsning til subkutan injektion, indeholder:
English: This variability in V1 (27.1% and 19.0%) contributed by the range in BSA (1.53 to 2.32 m2) and concurrent CHOP therapy, respectively, were relatively small.
Danish: kemoterapi, bidrog til den relativt ringe variation i V1 (27,1 % og 19,0 %).