natgillin/translations-raw huggingface dataset:
Den anbefalede dosis af MabThera til vedligeholdelsesbehandling hos patienter med recidiveret/ refraktært follikulært lymfom, som har responderet på induktionsbehandling, er 375 mg/m2 
The recommended dose of MabThera used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2
Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 patienter): 
Very rare side effects (may affect up to 1 in 10, 000 people):
Komplet responsrate a 
ORR a
Samtidig administration af MabThera synes ikke at påvirke farmakokinetikken af fludarabin eller cyklofosfamid. 
Co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
10,49 år log-rank p-værdi hazard ratio (95% KI) risiko reduktion Sekondært effektmål Samlet overlevelse (median) 
10.49 years log-rank p value hazard ratio (95% CI) risk reduction Secondary efficacy Overall survival (median)
1 Hyppigheden stammer fra laboratorie-værdier, som var indsamlet som en del af rutinemæssig laboratorie-overvågning i kliniske studier 2 Hyppigheden stammer fra data efter markedsføring 3 Reaktioner, som forekommer inden for 24 timer efter infusion. 
1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials
Tabel 9 Vedligeholdelsesfase: Oversigt over effektdata for MabThera versus observation (28 måneders median observationstid) 
Table 9 Maintenance phase: overview of efficacy results MabThera vs. observation (28 months median observation time) Efficacy Parameter
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.
Hvert hætteglas indeholder 1600 mg/13,4 ml rituximab. 
Each vial contains 1600 mg/ 13.4 mL rituximab.
Rituximab subkutan formulering (n = 88) 
Rituximab subcutaneous formulation (n = 88)
Disse symptomer er sædvanligvis reversible, når MabThera-infusionen afbrydes, og der administreres et antipyretikum, et antihistamin og undertiden oxygen, intravenøst saltvand eller bronchodilaterende midler og glukokortikoider om nødvendigt. 
These symptoms are usually reversible with interruption of MabThera infusion and administration of an anti-pyretic, an antihistaminic, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
42-måneder p=0,029 
42-months p = 0.029
Den anbefalede dosis af MabThera monoterapi til induktionsbehandling hos voksne patienter med grad III-IV follikulært lymfom, som er resistente over for behandling med kemoterapi eller som er i deres anden eller efterfølgende recidiv efter kemoterapi, er 375 mg/m2 legemsoverfladeareal, givet som intravenøs infusion én gang ugentligt i 4 uger. 
The recommended dose of MabThera monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
Læger bør udvise forsigtighed, når de overvejer brugen af MabThera til patienter, der tidligere har haft recidiverende eller kroniske infektioner eller patienter med tilgrundliggende forhold, der yderligere kan prædisponere dem til alvorlig infektion (se pkt. 
Physicians should exercise caution when considering the use of MabThera in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
Rituximab subkutan formulering (n = 205) 
Rituximab subcutaneous formulation (n = 205)
Tabel 6 Vedligeholdelsesfase: Oversigt over effektdata for MabThera versus observation (28 måneders median observationstid) 
Table 6 Maintenance phase: overview of efficacy results MabThera vs. observation (28 months median observation time) Efficacy Parameter
Et Kaplan-Meier estimat af den gennemsnitlige længde af den progressionsfrie overlevelse var 35 måneder for R-CHOP armen sammenlignet med 13 måneder for CHOP armen. 
Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41 %.
Den anbefalede dosis af MabThera i kombination med kemoterapi til induktionsbehandling hos tidligere ubehandlede patienter eller patienter med recidiveret/refraktært follikulært lymfom er: første behandlingsserie med MabThera intravenøs formulering 375 mg/m2 
The recommended dose of MabThera in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: first cycle with MabThera intravenous formulation 375 mg/m2
Eftersom hypotension kan forekomme under administration af MabThera, bør det overvejes at afbryde behandling med antihypertensive lægemidler 12 timer før infusion med MabThera. 
Since hypotension may occur during MabThera administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the MabThera infusion.
lungeinfiltrater 
lung infiltration,
MabThera er i kombination med kemoterapi indiceret til behandling af kronisk lymfatisk leukæmi (CLL) hos patienter, som ikke tidligere er behandlet, og til patienter med relaps/refraktær CLL. 
MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.
Der er rapporteret hepatitis B-reaktivering hos patienter med non-Hodgkins lymfom, som fik MabThera i kombination med cytotoksisk kemoterapi (se non-Hodgkins lymfom). 
In patients with non-Hodgkin's lymphoma receiving MabThera in combination with cytotoxic chemotherapy, cases of hepatitis B reactivation have been reported (see non-Hodgkin's lymphoma).
Den anbefalede dosis af MabThera i kombination med kemoterapi til tidligere ubehandlede patienter og til relaps/refraktære patienter er 375 mg/m2 legemsoverflade, som gives på dag 0 af første behandlingsserie, efterfulgt af 500 mg/m2 legemsoverflade på dag 1 af hver af de følgende serier, i alt 
The recommended dosage of MabThera in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
Efter anden infusion i den anden behandlingsserie var den gennemsnitlige terminale halveringstid for elimination 19 dage for doseringsgruppen 2 x 500 mg og varierede fra 21 til 22 dage for doseringsgruppen 2 x 1.000 mg. 
Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 x 500 mg dose and ranged from 21 to 22 days for the 2 x 1000 mg dose.
Hyppigheden er 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-kriterier ≥ Grad 3). 
For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+"
MabThera 500 mg koncentrat til infusionsvæske, opløsning Hætteglas, af klart type I glas med butylgummiprop, indeholdende 500 mg rituximab i 50 ml. 
MabThera 500 mg concentrate for solution for infusion Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
MabThera er en brugsklar, klar til opaliserende, farveløs til gullig opløsning, leveret som opløsning til subkutan injektion i et farveløst hætteglas med butylgummiprop med aluminiumsforsegling og lyserødt vipbart plastiklåg. 
What MabThera 1400 mg solution for subcutaneous injection looks like and contents of the pack MabThera is a ready to use, clear to opalescent, colourless to yellowish liquid, supplied as a solution for subcutaneous injection in a colourless glass vial with a butyl rubber stopper with aluminium over seal and a pink plastic flip-off disk.
Der blev anvendt en dosis på 1400 mg subkutant, som var blevet fastsat i første del. Tidligere ubehandlede patienter med CD20-positivt, follikulært lymfom af grad 1, 2 eller 3a (n=283) blev inkluderet i anden del. 
Previously untreated patients with CD20-positive, Follicular Lymphoma Grade 1, 2 or 3a (n=283) were enrolled in the stage 2.
Serum-MabThera Cmax ved behandlingsserie 6 var lavere i den subkutane behandlingsarm end i den intravenøse, med geometriske gennemsnitsværdier (CV %) på henholdsvis 202 (36,1) μg/ml og 280 (24,6) μg/ml medførende en geometrisk gennemsnitsratio (Cmax, SC/Cmax, i.v.) 
The serum MabThera Cmax at Cycle 6 was lower in the subcutaneous arm than the intravenous, with geometric mean (CV%) values of 202 (36.1) μg/mL and 280 (24.6) μg/mL with the resulting geometric mean ratio (Cmax, SC/Cmax, IV) of 0.719 (90% CI: 0.653, 0.792).
Bivirkninger rapporteret ved brug af MabThera intravenøs formulering 
Adverse reactions reported in MabThera intravenous formulation usage
MabThera-vedligeholdelsesbehandling gav konsekvent fordel i alle testede prædefinerede undergrupper: Køn (mand, kvinde), alder (< 60 år, ≥ 60 år), FLIPI-score (≤1, 2 eller ≥3), 
MabThera maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age (< 60 years, >= 60 years), FLIPI score (<=1, 2 or >= 3), induction therapy (R-CHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR,CRu or PR).
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med MabThera i alle undergrupper af den pædiatriske population med follikulært lymfom og CLL (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with MabThera in all subsets of the paediatric population with follicular lymphoma and CLL.
I de randomiserede studier var hyppigheden af lokale candidainfektioner og herpes zoster højere i den arm, som indeholdt MabThera. 
Localised candida infections as well as Herpes zoster were reported at a higher incidence in the MabThera-containing arm of randomised studies.
MabThera bør gives på dag 1 i hver kemoterapiserie, efter intravenøs indgift af glukokortikoidkomponenten, hvis det anvendes. 
MabThera should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Tabel 2b Førstelinjebehandling af kronisk lymfatisk leukæmi Hazard ratioer for progressionsfri overlevelse efter Binet stadium (ITT) - median observationstid: 48,1 måneder 
Table 2b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time Progression-free survival (PFS)
Sådan får du MabThera 
How to store MabThera
• Recidiveret/refraktært follikulært lymfom 
• Relapsed/refractory follicular lymphoma
Der var ikke nogen umiddelbar påvirkning af sikkerhed og virkning ved tilstedeværelse af anti-rituximabantistoffer eller anti-rHuPH20-antistoffer. 
There was no apparent impact of the presence of anti-rituximab or anti-rHuPH20 antibodies on safety or efficacy.
Luftveje, thorax og mediastinum Dyspnø 
Respiratory, thoracic and mediastinal disorders Cough
granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris. 
granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
Hvert hætteglas indeholder 1400 mg/11,7 ml rituximab. 
Each vial contains 1400 mg/11.7 mL rituximab.
Hvert 10 ml hætteglas indeholder 100 mg rituximab. 
Each 10mL vial contains 100 mg of rituximab.
Inden behandling med MabThera som subkutane injektioner, skal alle patienter altid have fået en fuld dosis intravenøs infusion af MabThera intravenøs formulering. 
Before starting MabThera subcutaneous injections, all patients must always receive beforehand, a full dose of MabThera by intravenous infusion, using MabThera intravenous formulation.
Blod og lymfesystem neutropeni, leukopeni, +febril neutropeni, +trombocytopeni anæmi, +pancytopeni, +granulocytopeni koagulations sygdomme, aplastisk anæmi, hæmolytisk anæmi, lymfadenopati forbigående stigning i serum IgM3 
Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocyt openia anaemia, +pancytopenia, +granulocytopeni a coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Den anbefalede dosis af MabThera i kombination med kemoterapi til induktionsbehandling hos tidligere ubehandlede patienter eller patienter med recidiveret/refraktært follikulært lymfom er 375 mg/m2 legemsoverfladeareal pr. behandlingsserie i op til 8 serier. 
The recommended dose of MabThera in combination with chemotherapy for induction treatment of previously untreated or relapsed/refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
MabThera 1600 mg anvendes sammen med kemoterapi. 
You will be given MabThera 1600 mg with other medicines called “chemotherapy”.
Tabel 10b Førstelinjebehandling af kronisk lymfatisk leukæmi Hazard ratioer for progressionsfri overlevelse efter Binet stadium (ITT) - median observationstid: 48,1 måneder 
Table 10b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time Progression-free survival (PFS)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 1600 mg/13,4 ml rituximab. 
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 1600 mg/13.4 mL rituximab.
Det skal du vide, før du begynder at få MabThera 
What you need to know before you use MabThera
MabThera er i kombination med kemoterapi indiceret til voksne til behandling af kronisk lymfatisk leukæmi (CLL) hos voksne patienter, som ikke tidligere er behandlet, og til patienter med relaps/refraktær kronisk lymfatisk leukæmi. 
MabThera is indicated in adults in combination with chemotherapy for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL).
Symptomer inkluderede smerter, hævelse, induration, blødning, erythema, kløe og udslæt (se pkt. 
Symptoms included pain, swelling, induration, haemorrhage, erythema, pruritus and rash (see section 4.8).
Patienter bør evalueres for enhver potentiel risiko for infektioner, før der gives efterfølgende behandling med MabThera. 
Before giving a subsequent course of MabThera treatment, patients should be re-evaluated for any potential risk for infections.
Mavetarmkanalen dyspepsi, diarré, gastroøsofageal refluks, ulceration i munden, smerter i øvre del af abdomen 
Dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
De mest almindelige lokale hudreaktioner var erytem ved injektionsstedet (26 %), smerte ved injektionsstedet (16 %) og ødemer ved injektionsstedet (5 %). 
Most common local cutaneous reactions were injection site erythema (26%), injection site pain (16%), and injection site swelling (5%).Two patients in SAWYER trial who experienced Grade 3 local cutaneous reactions (injection site erythema, injection site pain and injection site swelling).
Tabel 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 
Table 1 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
medium BSA < 1,90 m2; højt BSA ≥ 1,90 m2). 
≥ 1.90 m2).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 1400 mg/11,7 ml rituximab. 
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 1400 mg/11.7 mL rituximab.
I alt blev 810 patienter (403 R-FC, 407 FC) i 1. linje-studiet (tabel 10a og tabel 10b) og 552 patienter (276 R-FC, 276 FC) i relaps/refraktær studiet (tabel 11) analyseret for effekt. 
FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med MabThera i alle undergrupper af den pædiatriske population med autoimmun artrit (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with MabThera in all subsets of the paediatric population with autoimmune arthritis.
9.25 years log-rank p-værdi hazard ratio (95% KI) risiko reduktion TNLT (median) 
9.25 years log-rank p value hazard ratio (95% CI) risk reduction TNLT (median)
MabThera kan anvendes alene eller sammen med kemoterapi. 
MabThera can be given alone or with other medicines called “chemotherapy”.
MabThera 100 mg koncentrat til infusionsvæske, opløsning Hætteglas, af klart type I glas med butylgummiprop, indeholdende 100 mg rituximab i 10 ml. 
MabThera 100 mg concentrate for solution for infusion Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Vedligeholdelsesbehandling med MabThera resulterede i en klinisk relevant og statistisk signifikant forbedring af det primære endepunkt investigatorbedømt progressionsfri overlevelse, sammenlignet med observation hos patienter med tidligere ubehandlet follikulært lymfom (tabel 4). 
The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with MabThera resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 4).
MabThera er, i kombination med CHOP-kemoterapi (cyclophosphamid, doxorubicin, vincristin og prednisolon), indiceret til behandling af patienter med CD20 positivt, diffust storcellet B-celle non-Hodgkin-lymfom. 
MabThera is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
MabThera 100 mg koncentrat til infusionsvæske, opløsning MabThera 500 mg koncentrat til infusionsvæske, opløsning 
MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion
+venstre ventrikel svigt, +supraventrikulær takykardi, +ventrikulær takykardi, +angina, +myokardieiskæmi, bradykardi, 
+left ventricular failure, +supraventricu lar tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia severe cardiac disorders 4 and 6
Immunsystemet infusionsrelaterede reaktioner, angioødem hypersensitivitet anafylaksi tumorlysesyndrom, cytokinfrigivelsessyndrom4, serumsygdom infusionsrelateret akut, reversibel trombocytopeni4 
Immune system disorders infusionrelated reactions4, angioedema hypersensitivity anaphylaxis tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-related acute reversible thrombocytopenia
Vedligeholdelsesbehandling med MabThera resulterede i en klinisk relevant og statistisk signifikant forbedring af det primære endepunkt investigatorbedømt progressionsfri overlevelse, sammenlignet med observation hos patienter med tidligere ubehandlet follikulært lymfom (tabel 7). 
The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with MabThera resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Tabel 11 Behandling af relapsed/refraktær kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for MabThera plus FC versus FC alene (median observationstid: 25,3 måneder) 
Table 11 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
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.