natgillin/translations-raw huggingface dataset:
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 500 mg koncentrat za raztopino za infundiranje Prozorne viale iz stekla tipa I z gumijastim zamaškom, ki vsebujejo 500 mg rituksimaba v 50 ml.
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). 
Ob mediani časa 25 mesecev opazovanja od randomizacije so izvedli vnaprej določeno primarno analizo; vzdrževalno zdravljenje z zdravilom MabThera pri bolnikih s predhodno nezdravljenimi folikularnimi limfomi je klinično pomembno in statistično značilno izboljšalo primarni opazovani dogodek - preživetje brez napredovanja bolezni (progression free survival - PFS), kot ga je določil raziskovalec - v primerjavi z opazovano skupino (preglednica 4).
Very rare cases of fatal progressive multifocal leukoencephalopathy (PML) have been reported following use of MabThera for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and vasculitis. 
Pri uporabi zdravila MabThera za zdravljenje avtoimunskih bolezni so poročali o smrtnih primerih progresivne multifokalne levkoencefalopatije, in sicer pri revmatoidnem artritisu in avtoimunskih boleznih, za katere zdravilo ni odobreno, sistemskem eritematoznem lupusu (SLE) in vaskulitisu.
The majority of patients had received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. 
Večina bolnikov je prejela rituksimab v kombinaciji s kemoterapijo ali v okviru presaditve krvotvornih matičnih celic.
In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of MabThera. 
Tudi fludarabin in ciklofosfamid nista imela opaznega učinka na farmakokinetiko zdravila MabThera.
• Infusion-related reactions (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4. 
· z infuzijo povezane reakcije (vključno s sindromom sproščanja citokinov, sindromom razpada tumorja), glejte poglavje 4.4; · okužbe, glejte poglavje 4.4; · kardiovaskularni dogodki, glejte poglavje 4.4.
MabThera is used for the treatment of rheumatoid arthritis. 
Zdravilo MabThera uporabljamo za zdravljenje revmatoidnega artritisa, ki je bolezen sklepov.
MabThera is associated with infusion/administration-related reactions, which may be related to release of cytokines and/or other chemical mediators. 
Zdravilo MabThera lahko spremljajo reakcije, povezane z infuzijo/dajanjem zdravila, ki morda nastanejo zaradi sprostitve citokinov in/ali drugih kemičnih mediatorjev.
Newly diagnosed n=48 
Novoodkriti n = 48
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. 
V primerjavi z opazovano skupino so med največ dveletnim vzdrževalnim zdravljenjem z zdravilom MabThera opazili večjo pogostnost okužb na splošno, vključno z okužbami 3. ali 4. stopnje.
Primary efficacy Progression-free survival (median) 
Preživetje brez napredovanja bolezni (mediana)
How MabThera is given 
Kako se daje zdravilo MabThera
95% CI 
95-% IZ
MabThera maintenance treatment consisted of a single infusion of MabThera at 375 mg/m2 body surface area given every 3 months until disease progression or for a maximum period of two years. 
V okviru vzdrževalnega zdravljenja so bolniki prejeli eno infuzijo zdravila MabThera v odmerku 375 mg/m2 telesne površine vsake 3 mesece do napredovanja bolezni ali največ 2 leti.
• MabThera will be given to you on the same day as your chemotherapy. 
ga boste dobili isti dan kot kemoterapijo.
Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells. 
Domena rituksimaba Fab se veže na antigen CD20 na B-limfocitih in prek domene Fc sproži imunska dogajanja, ki privedejo do razgradnje celic B. Mogoča mehanizma celične razgradnje sta od komplementa odvisna citotoksičnost (complement-dependent cytotoxicity - CDC), ki je posledica vezave C1q, in od protiteles odvisna celična citotoksičnost (antibody-dependent cellular cytotoxicityADCC), ki jo posreduje eden ali več receptorjev Fcg na površini granulocitov, makrofagov ali naravnih celic ubijalk.
The objective of the Part 1 was to select a MabThera subcutaneous formulation dose that resulted in comparable MabThera serum Ctrough levels compared with MabThera intravenous formulation. 
Cilj 1. dela preskušanja je bil določiti odmerek podkožne oblike zdravila MabThera, ki v serumu doseže primerljivo najmanjšo koncentracijo zdravila MabThera pred naslednjim odmerkom (Ctrough), kot jo doseže intravenska oblika zdravila MabThera.
• you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis, 
· imate hudo srčno popuščanje ali hudo, neurejeno srčno bolezen in imate tudi revmatoidni artritis, granulomatozo s poliangiitisom, mikroskopski poliangiitis ali navadni pemfigus.
In addition, other serious viral infections either new, reactivated or exacerbated, some of which were fatal, have been reported with MabThera treatment. 
MabThera opisane druge resne virusne okužbe, bodisi novonastale, ponovitve ali poslabšanja;
The efficacy and safety of MabThera in combination with short-term, low-dose glucocorticoid (prednisone) therapy were evaluated in newly diagnosed patients with moderate to severe pemphigus (74 pemphigus vulgaris [PV] and 16 pemphigus foliaceus [PF]) in this randomised, open-label, controlled, multicenter study. 
MabThera v kombinaciji s kratkotrajnim zdravljenjem z majhnim odmerkom glukokortikoida (prednizon) ocenili pri novodiagnosticiranih bolnikih z zmernim do hudim pemfigusom (74 z navadnim pemfigusom [pemphigus vulgaris] in 16 z luščečim se pemfigusom [pemphigus foliaceus]).
Concomitant/sequential use of other DMARDs in rheumatoid arthritis The concomitant use of MabThera and anti-rheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended. 
Sočasna uporaba zdravila MabThera in zdravil za zdravljenje revmatičnih bolezni, razen omenjenih v indikaciji in odmerjanju za revmatoidni artritis, ni priporočljiva.
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 
V randomiziranem, odprtem preskušanju je 399 predhodno nezdravljenih starejših (starih od 60 do 80 let) bolnikov z difuznim velikoceličnim B limfomom prejelo osem ciklov standardne kemoterapije CHOP (750 mg/m2 ciklofosfamida, 50 mg/m2 doksorubicina, 1,4 mg/m2 do največ 2 mg/m2 vinkristina na prvi dan ter 40 mg/m2 prednizolona na 1. do 5. dan) vsake 3 tedne 8 ciklov ali pa 375 mg/m2
MabThera is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators. 
Zdravilo MabThera lahko povzroči reakcije, povezane z infuzijo, ki nastanejo zaradi sprostitve citokinov in/ali drugih kemičnih mediatorjev.
Studies with MabThera intravenous formulation in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1x109/L between day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count below 1x109/L later than 42 days after last dose in patients with no previous prolonged neutropenia or who recovered prior to day 42) following treatment with MabThera plus FC.There were no differences reported for the incidence of anaemia. 
V študijah z intravensko obliko zdravila MabThera pri bolnikih s KLL, ki še niso bili zdravljeni, in pri bolnikih s KLL, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje, so ocenili, da je bila pri do 25 % bolnikov, zdravljenih z R-FC, nevtropenija podaljšana (opredeljena kot število nevtrofilcev, ki med dnevoma 24 in 42 po zadnjem prejetem odmerku ostane pod 1x109/l) ali pa se je po zdravljenju z zdravilom MabThera in FC pojavila kasneje (opredeljena kot število nevtrofilcev pod 1x109/l po 42. dnevu od zadnjega prejetega odmerka pri bolnikih, ki niso imeli podaljšane nevtropenije ali pa so si opomogli pred dnevom 42).
MabThera monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. 
Zdravilo MabThera je indicirano za samostojno zdravljenje bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila.
Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischaemia) in 3% of patients treated with MabThera compared to <1% on observation. 
O resnih neželenih dogodkih, povezanih s srcem (vključno z atrijsko fibrilacijo, miokardnim infarktom, popuščanjem levega prekata, ishemijo miokarda), so poročali pri 3 % bolnikov,
Neither age, sex, lymphoma grade, initial diagnosis, presence or absence of bulky disease, normal or high LDH nor presence of extranodal disease had a statistically significant effect (Fisher's exact test) on response to MabThera. 
Na odgovor na zdravilo MabThera naslednji dejavniki niso imeli statistično značilnega vpliva (Fisherjev natančni test): starost, spol, gradus limfoma, začetna diagnoza, prisotnost ali odsotnost obsežne bolezni, normalna ali visoka koncentracija LDH ali ekstranodalna bolezen.
• The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any. 
· podrobne podatke o tveganju za PML, informacije o nujnosti njene pravočasne diagnoze in ustreznih ukrepov za diagnosticiranje te bolezni, · informacije o nujnosti svetovanja bolnikom glede tveganja za okužbe in PML, vključno s simptomi, na katere naj bodo pozorni, in informacije o nujnosti, da nemudoma obvestijo svojega zdravnika, če se pojavijo kateri od teh simptomov, · informacije o nujnosti, da opozorilno kartico izročijo bolniku ob vsakem infundiranju.
Infections and infestations Bronchitis Rhinitis General disorders and administration site conditions Pyrexia Influenza-like illness Oedema peripheral Gastrointestinal disorders Diarrhoea Respiratory, thoracic and mediastinal disorders Dyspnoea Injury, poisoning and procedural complications Infusion-related reactions 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility. 
Infekcijske in parazitske bolezni bronhitis rinitis Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura gripi podobna bolezen periferni edemi Bolezni prebavil driska Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja Poškodbe in zastrupitve in zapleti po posegih z infuzijo povezane reakcije2
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. 
Med zdravljenjem v študijah zdravila MabThera v kombinaciji s kemoterapijo sta bili 3. ali 4. stopnja levkopenije (R-CHOP 88 % v primerjavi s CHOP 79 %) in nevtropenije (R-CVP 24 % v primerjavi s CVP 14 %; R-CHOP 97 % v primerjavi s CHOP 88 %) po navadi pogostejši kot s kemoterapijo samo.
Occurred at various times up to several months after completion of MabThera therapy 6 observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly associated with infusion-related reactions 7 includes fatal cases 
6 Opaženi v glavnem pri bolnikih z obstoječimi boleznimi srca in/ali kardiotoksično kemoterapijo ter pretežno v zvezi z reakcijami, povezanimi z infuzijo.
MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion 
MabThera 100 mg koncentrat za raztopino za infundiranje MabThera 500 mg koncentrat za raztopino za infundiranje
Adverse reactions reported in MabThera intravenous formulation usage 
Neželene reakcije, opisane med uporabo intravenske oblike zdravila MabThera
The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 1400 mg once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 administrations in total). 
Priporočeni odmerek podkožne oblike zdravila MabThera, uporabljenega za vzdrževalno zdravljenje bolnikov s predhodno nezdravljenimi folikularnimi limfomi, ki so se odzvali na indukcijsko zdravljenje, je: 1400 mg na 2 meseca (z začetkom 2 meseca po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 12 aplikacij).
MabThera intravenous 
Intravensko infundiranje
The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the MabThera group and at a higher frequency than the comparator group. 
Neželeni učinki, navedeni v preglednici 3, so se v skupini, ki je prejemala zdravilo MabThera, pojavili z incidenco ≥ 5 % in pogosteje kot v primerjalni skupini.
The chemotherapy should be given after the MabThera infusion. 
Kemoterapijo boste dobili po infuziji zdravila MabThera.
A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial. 
V randomiziranem, dvojno slepem, s placebom kontroliranem multicentričnem preskušanju neinferiornosti z aktivnim primerjalnim zdravilom so vključili in v njej zdravili skupno 197 bolnikov, starih 15 let ali več s hudo, aktivno granulomatozo s poliangiitisom (75 %) in mikroskopskim poliangiitisom (24 %).
The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps: 
Pri uporabi in odstranjevanju brizg in drugih ostrih medicinskih odpadkov je treba strogo upoštevati naslednje: · Igel in brizg se nikdar ne sme ponovno uporabiti.
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). 
V nerandomizirani študiji so bolniki, ki so prejeli samostojno zdravljenje z zdravilom MabThera ob ponovitvi nizkomalignega NHL, v primerjavi z zdravimi kontrolnimi osebami, ki niso prejele zdravila, v manjšem deležu dogovorili nižji delež odgovora na cepljenje s cepivom proti tetanusu (recall antigen) (16 % v primerjavi z 81 %) in neoantigenom KLH (Keyhole Limpet Haemocyanin) (4 % v primerjavi s 76 %, ko so določevali > 2-kratno povečanje v titru protiteles).
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]. 
Geometrične sredine Ctrough (KV %) v 5. ciklu (pred odmerkom 6. cikla) so bile višje v skupini, ki je zdravilo MabThera prejemala podkožno (97,5 µg/ml (42,6)), kot v skupini, ki je zdravilo MabThera prejemala intravensko (61,5 µg/ml (63,9)); prilagojeno razmerje geometričnih sredin [90-% IZ] je bilo
ORRa 
ORRa ocena
Patients treated with MabThera may receive non-live vaccinations. 
Bolniki, ki se zdravijo z zdravilom MabThera, lahko prejmejo mrtva cepiva, vendar je lahko odgovor nanje zmanjšan.
Local cutaneous reactions of any grade in the MabThera subcutaneous arm were most common during the first subcutaneous cycle (Cycle 2), followed by the second, and the incidence decreased with subsequent injections. 
Lokalne kožne reakcije katere koli stopnje so bile v skupini bolnikov, ki so prejemali podkožno obliko zdravila MabThera, najpogostejše med prvim ciklom zdravljenja s podkožno obliko (2. cikel).
The geometric mean tmax in the MabThera subcutaneous group was approximately 3 days as compared to the tmax occuring at or close to the end of the infusion for the MabThera intravenous group. 
Geometrična sredina časa do največje koncentracije (tmax) je bila v skupini s podkožno obliko zdravila približno 3 dni; pri intravenski obliki zdravila MabThera je bil tmax dosežen na koncu ali blizu konca infuzije.
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 
Bolezni krvi in limfatičnega sistema nevtropenija, levkopenija, +febrilna nevtropenija, +trombocito penija anemija, +pancitopenija, +granulocitopeni ja motnje koagulacije,
• multiple-organ failure. 
· odpoved več organov
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. 
Med zdravljenjem v študijah zdravila MabThera v kombinaciji s kemoterapijo sta bili 3. ali 4. stopnja levkopenije (R-CHOP 88 % v primerjavi s CHOP 79 %, R-FC 23 % v primerjavi s FC 12 %), nevtropenije (R-CVP 24 % v primerjavi s CVP 14 %, R-CHOP 97 % v primerjavi s CHOP 88 %, R-FC: 30 % v primerjavi s FC 19 % pri predhodno nezdravljeni KLL), pancitopenije (R-FC: 3 % v primerjavi s FC 1 % pri predhodno nezdravljeni KLL) po navadi pogostejši kot s kemoterapijo samo.
• low number of white blood cells, with or without fever or blood cells called “platelets” 
· bakterijske ali virusne okužbe, bronhitis · majhno število belih krvnih celic (z zvišano telesno temperaturo ali brez nje) ali krvnih celic, ki jih imenujemo trombociti (krvne ploščice)
Exploratory analyses showed response rates among BSA, chemotherapy and gender subgroups were not notably different from the ITT population. 
a na koncu indukcije b v času končne analize (mediana spremljanja 58 mesecev) Eksplorativne analize so pokazale, da v podskupinah, ločenih glede na telesno površino, kemoterapijo in spol, deleži odgovorov niso bili pomembno drugačni od populacije, ki so jo nameravali zdraviti.
b) If you are being treated for chronic lymphocytic leukaemia When you are treated with MabThera in combination with chemotherapy, you will receive MabThera infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total. 
Ko se boste zdravili z zdravilom MabThera v kombinaciji s kemoterapijo, boste dobili infuzijo zdravila MabThera 0. dan 1. cikla in nato 1. dan vsakega naslednjega cikla, skupaj 6 ciklov.
10.49 years log-rank p value hazard ratio (95% CI) risk reduction Secondary efficacy Overall survival (median) 
10,49 let vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
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. 
MabThera 100 mg koncentrat za raztopino za infundiranje Prozorne viale iz stekla tipa I z gumijastim zamaškom, ki vsebujejo 100 mg rituksimaba v 10 ml.
You will always be given MabThera as a drip (intra-venous infusion) at the start of your treatment. 
Na začetku zdravljenja boste zdravilo MabThera vedno dobili v intravenski infuziji.
• MabThera subcutaneous formulation (n= 205): first cycle MabThera intravenous formulation plus 7 cycles of MabThera subcutaneous formulation in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. 
· Podkožna oblika zdravila MabThera (n = 205): prvi cikel z intravensko obliko zdravila MabThera in nato 7 ciklov podkožne oblike zdravila MabThera v kombinaciji z do 8 cikli kemoterapije CHOP ali CVP, uporabljene enkrat na 3 tedne.
The majority of patients had received MabThera in combination with chemotherapy or as part of a hematopoietic stem cell transplant. 
Večina bolnikov je prejemala zdravilo MabThera v kombinaciji s kemoterapijo ali v okviru presaditve krvotvornih matičnih celic.
The most common infections in the MabThera arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster. 
MabThera so bile okužbe zgornjih dihal, gastroenteritis, okužbe sečil in herpes zoster.
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). 
V odprtem randomiziranem preskušanju so skupaj 332 predhodno še nezdravljenih bolnikov s folikularnimi limfomi randomizirali na prejemanje kemoterapije CVP (750 mg/m2 ciklofosfamida, 1,4 mg/m2 vinkristina do največ 2 mg 1. dan in 40 mg/m2/dan prednizolona od 1. do 5. dneva) na 3 tedne 8 ciklov, ali na 375 mg/m2 zdravila MabThera v kombinaciji s CVP (R-CVP).
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). 
V nerandomizirani študiji so bolniki, ki so prejeli samostojno zdravljenje z zdravilom MabThera ob ponovitvi nizkomalignega NHL, v primerjavi z zdravimi kontrolnimi osebami, ki niso prejele zdravila, v manjšem deležu odgovorili na cepljenje s cepivom proti tetanusu (recall antigen) (16 % v primerjavi z 81 %) in neoantigenom KLH (Keyhole Limpet Haemocyanin) (4 % v primerjavi s 69 % ob določanju > 2-kratnega povečanja titra protiteles).
A maintenance infusion of 500 mg IV should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation. 
Vzdrževalno zdravljenje Vzdrževalno infuzijo 500 mg intravensko je treba uporabiti v 12. in 18. mesecu in nato vsakih
B-cell levels in human neonates following maternal exposure to MabThera have not been studied in clinical trials. 
V kliničnih preskušanjih niso proučevali števila celic B pri novorojenčkih mater, zdravljenih z zdravilom MabThera.
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. 
Evropska agencija za zdravila je odstopila od zahteve za predložitev izsledkov študij z rituksimabom za vse podskupine pediatrične populacije s kronično limfocitno levkemijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Clinical experience of MabThera concentrate for solution for infusion in Non-Hodgkin's lymphoma 
Klinične izkušnje s koncentratom za raztopino za infundiranje zdravila MabThera pri ne-Hodgkinovem limfomu Folikularni limfom