natgillin/translations-raw huggingface dataset:
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.
MabThera u trajanju do 2 godine primijećena je veća sveukupna učestalost infekcija, uključujući infekcije stupnja 3 i 4, u usporedbi s opservacijskom skupinom.
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
Poremećaji krvi i limfnog sustava neutropenija, leukopenija, +febrilna neutropenija, +trombocitopenija anemija, +pancitopenija, +granulocitopenija poremećaji zgrušavanja,
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
U randomiziranom otvorenom ispitivanju ukupno je 399 prethodno neliječenih starijih bolesnika (u dobi od 60 do 80 godina) s difuznim limfomom velikih B-stanica primalo standardnu CHOP kemoterapiju (ciklofosfamid 750 mg/m2, doksorubicin 50 mg/m2, vinkristin 1,4 mg/m2 do najviše
MabThera is indicated in adults in combination with chemotherapy for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL).
4.1 Terapijske indikacije MabThera je u kombinaciji s kemoterapijom indicirana za liječenje odraslih bolesnika s prethodno neliječenom i relapsirajućom/refraktornom kroničnom limfocitnom leukemijom (KLL).
4.06 years
6.3 Rok valjanosti
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.
Terapija održavanja lijekom MabThera dovela je do klinički relevantnih i statistički značajnih poboljšanja u primarnoj mjeri ishoda, što je bio PFS (vrijeme od randomizacije na terapiju održavanja do relapsa, progresije bolesti ili smrti), u usporedbi s opservacijskom skupinom (p < 0,0001, log-rang test).
How MabThera is given
Kako se MabThera primjenjuje
The estimated median terminal elimination half-life of MabThera was 22 days (range, 6.1 to 52 days).
Procijenjeni medijan vrijednosti terminalnog poluvremena eliminacije lijeka MabThera u formulaciji za supkutanu primjenu iznosio je 29,7 dana (raspon: 9,9 do 91,2 dana).
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of MabThera.
Prije svake primjene lijeka MabThera uvijek treba primijeniti premedikaciju koja obuhvaća antipiretik i antihistaminik, npr. paracetamol i difenhidramin.
Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with MabThera.
MabThera opažena je hipogamaglobulinemija (IgA, IgG ili IgM ispod donje granice normalnih vrijednosti).
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).
U nerandomiziranom ispitivanju, bolesnici u relapsu NHL-a niskog stupnja malignosti koji su primali monoterapiju lijekom MabThera u formulaciji za intravensku primjenu su u usporedbi sa zdravim neliječenim kontrolnim ispitanicima imali nižu stopu odgovora na cijepljenje antigenom tetanusa (16% u odnosu na 81%) i Keyhole Limpet Haemocyanin (KLH) neoantigenom (4% u odnosu na 69% kada se mjerilo više nego dvostruko povećanje titra antitijela).
Adverse reactions reported in MabThera subcutaneous formulation usage
Nuspojave prijavljene pri uporabi formulacije lijeka MabThera za supkutanu primjenu
Subcutaneous injections:
Prošireni tumori:
body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
do progresije bolesti ili najdulje dvije godine (ukupno 8 infuzija).
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.
· Relapsirajući/refraktorni folikularni limfom Preporučena doza lijeka MabThera u monoterapiji kod početnog liječenja odraslih bolesnika oboljelih od folikularnog limfoma stadija III-IV koji su rezistentni na kemoterapiju ili su u drugom odnosno sljedećem relapsu nakon kemoterapije iznosi 375 mg/m2 površine tijela, a primjenjuje se u obliku intravenske infuzije jedanput tjedno tijekom četiri tjedna.
Co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Istodobna primjena lijeka MabThera nije utjecala na farmakokinetiku fludarabina niti ciklofosfamida.
MabThera 100 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab.
MabThera 100 mg koncentrat za otopinu za infuziju Jedan ml sadrži 10 mg rituksimaba.
MabThera is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
MabThera se povezuje s reakcijama na infuziju, koje mogu biti posljedica otpuštanja citokina i/ili drugih kemijskih medijatora.
Clinical experience of MabThera subcutaneous formulation in chronic lymphocytic leukaemia
Klinička iskustva s primjenom lijeka MabThera u formulaciji za supkutanu primjenu u liječenju kronične limfocitne leukemije
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).
Najčešće lokalne kožne reakcije bile su eritem na mjestu injekcije (26%), bol na mjestu injekcije (16%) i oticanje na mjestu injekcije (5%).
Very rare cases of fatal PML have been reported following use of MabThera.
Nakon primjene lijeka MabThera prijavljeni su vrlo rijetki slučajevi PML-a sa smrtnim ishodom.
+myocardial infarction4 and 6,
+infarkt miokarda4 i 6, aritmija, +fibrilacija atrija, tahikardija,
Information to appear on Peel-off sticker
Podaci koji se moraju nalaziti na odvojivoj naljepnici Lot
Localized candida infections as well as Herpes zoster were reported at a higher incidence in the MabThera-containing arm of randomized studies.
Lokalizirane infekcije kandidom te herpes zoster u randomiziranim su ispitivanjima prijavljeni s većom incidencijom u skupinama koje su primale lijek MabThera.
In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
U KLL-u je ukupna incidencija poremećaja živčanog sustava stupnja 3 ili 4 bila niska i u ispitivanju prve linije liječenja (4% R-FC, 4% FC) i u ispitivanju relapsirajuće/refraktorne bolesti (3% R-FC, 3% FC).
MabThera intravenous formulation was used at the standard dose of 375 mg/m2.
MabThera u formulaciji za intravensku primjenu davala se u standardnoj dozi od 375 mg/m2 površine tijela.
Skin and subcutaneous tissue disorders alopecia
Poremećaji kože i potkožnog tkiva alopecija svrbež urtikarija poremećaj kože
patients.
DJECE
The majority of patients had received MabThera in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Većina bolesnika primala je lijek MabThera u kombinaciji s kemoterapijom ili u postupku transplantacije hematopoetskih matičnih stanica.
collapse
Cijepljenje
ORR, % CR,
ORR je iznosio 38%
Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with MabThera.
U bolesnika liječenih lijekom MabThera pojavljivali su se angina pektoris, srčane aritmije poput undulacije i fibrilacije atrija, zatajenje srca i/ili infarkt miokarda.
The dose of 1600 mg of MabThera subcutaneous formulation was selected for the Part 2 of the study.
Za 2. dio ispitivanja odabrana je doza supkutane formulacije lijeka MabThera od 1600 mg.
In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC).
U KLL-u je ukupna incidencija srčanih poremećaja stupnja 3 ili 4 bila niska i u ispitivanju prve linije liječenja (4% R-FC, 3% FC) i u ispitivanju relapsirajuće/refraktorne bolesti (4% R-FC, 4% FC).
virus.
ciklusa.
Also do not breast-feed for 12 months after your last treatment with MabThera.
Ne smijete dojiti dijete tijekom liječenja lijekom MabThera i još 12 mjeseci nakon posljednje primjene lijeka jer se MabThera može izlučiti u majčino mlijeko.
Cases of hepatitis B reactivation have been reported in patients receiving the MabThera intravenous formulation including fulminant hepatitis with fatal outcome.
U osoba koje su primale formulaciju lijeka MabThera za intravensku primjenu prijavljeni su slučajevi reaktivacije hepatitisa B, uključujući fulminantni hepatitis sa smrtnim ishodom.
Some vaccines should not be given at the same time as MabThera or in the months after you receive MabThera.
MabThera ili nekoliko mjeseci nakon liječenja lijekom MabThera.
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.
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka MabThera u svim podskupinama pedijatrijske populacije s folikularnim limfomom i KLL-om.
• Weight loss
• probavne tegobe
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).
Terapija održavanja lijekom MabThera u bolesnika s prethodno neliječenim folikularnim limfomom dovela je do klinički i statistički značajnog poboljšanja u primarnoj mjeri ishoda, tj. preživljenju bez progresije bolesti (PFS) prema procjeni ispitivača, u usporedbi s opservacijskom skupinom (Tablica 7).
Further, a significantly higher proportion of patients achieved MCIDs for these scores (Table 14).
Nadalje, značajno je veći udio bolesnika postigao
Table 2 Efficacy results for SABRINA (BO22334) (Intent to Treat Population) Pooled Stages 1 & 2 N = 410
Tablica 2 Rezultati za djelotvornost u ispitivanju SABRINA (BO22334) (populacija s namjerom liječenja)
Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of MabThera is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Bolesnici s reumatoidnim artritisom koji prethodno nisu liječeni metotreksatom Primjena lijeka MabThera ne preporučuje se u bolesnika koji prethodno nisu bili liječeni metotreksatom jer nije utvrđen povoljan omjer koristi i rizika.
MabThera subcutaneous formulation MabThera intravenous formulation
MabThera u formulaciji za supkutanu primjenu MabThera za intravensku primjenu
• A complex of symptoms occurring within a few weeks of an infusion of MabThera including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
MabThera, a obuhvaćaju reakcije nalik alergijskima kao što su osip, svrbež, bol u zglobovima, otečeni limfni čvorovi i vrućica
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 blue plastic flip-off disk.
Kako MabThera 1600 mg otopina za supkutanu injekciju izgleda i sadržaj pakiranja MabThera je bistra do opalescentna, bezbojna do žućkasta tekućina spremna za uporabu, dostupna u obliku otopine za supkutanu injekciju u bezbojnoj staklenoj bočici s butilnim gumenim čepom zabrtvljenim aluminijskim prstenom i plavim plastičnim „flip-off“ poklopcem.
Results from trial BP22333 are presented in section 5.2.
BP22333 prikazani su u dijelu 5.2. Ispitivanje BO22334 (SABRINA)
Since hypotension may occur during MabThera administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to giving MabThera.
S obzirom da tijekom primjene lijeka MabThera može doći do hipotenzije, potrebno je razmotriti mogućnost izostavljanja antihipertenzivne terapije 12 sati prije davanja infuzije.
Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Neurološki događaji Prijavljeni su slučajevi sindroma reverzibilne posteriorne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES) odnosno sindroma reverzibilne posteriorne leukoencefalopatije (engl. reversible posterior leukoencephalopathy syndrome, RPLS).
• short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba): · kratkotrajno povišenje količine nekih vrsta protutijela u krvi (imunoglobulina - IgM), kemijski poremećaji krvi uzrokovani raspadanjem umirućih stanica raka · oštećenje živaca u rukama i nogama, paraliza lica
The recommended dosage of MabThera for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Preporučena doza lijeka MabThera za liječenje običnog pemfigusa iznosi 1000 mg primijenjeno intravenskom infuzijom, a potom se nakon dva tjedna primjenjuje druga doza od 1000 mg intravenskom infuzijom u kombinaciji s glukokortikoidima čija se doza postupno smanjuje.
EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
Time to progression or death) PFS - preživljenje bez progresije bolesti
Musculo skeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Poremećaji mišićno-koštanog sustava artralgija/bol u kostima i mišićima,
Do not take MabThera if:
Nemojte primati lijek MabThera
Keep the vial in the outer carton, in order to protect from light.
Čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
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).
Terapija održavanja lijekom MabThera u bolesnika s prethodno neliječenim folikularnim limfomom dovela je do klinički i statistički značajnog poboljšanja u primarnoj mjeri ishoda, tj. preživljenju bez progresije bolesti (PFS) prema procjeni ispitivača, u usporedbi s opservacijskom skupinom (Tablica 4).
Following induction of remission with other standard of care immunosuppressants, MabThera maintenance treatment should be initiated during the 4 week period that follows disease remission.
terapiju održavanja lijekom MabThera treba započeti tijekom 4-tjednog razdoblja nakon nastupa remisije bolesti.
• feeling restless, problems falling asleep
· nemir, teškoće s usnivanjem
late neutropenia2 Serum sickness-like reaction
reakcija nalik serumskoj bolesti
Vascular disorders hypertension, orthostatic hypotension, hypotension vasculitis (predominatel y cutaneous), leukocytoclast ic vasculitis
Krvožilni poremećaji hipertenzija, ortostatska hipotenzija, hipotenzija vaskulitis (pretežno kutani),
Patients treated with MabThera in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
U bolesnika liječenih lijekom MabThera u kombinaciji s metotreksatom došlo je do značajno većeg smanjenja aktivnosti bolesti (DAS28, od engl.
Adverse reactions reported in MabThera intravenous formulation usage
Nuspojave prijavljene kod primjene formulacije lijeka MabThera za intravensku primjenu
How to store MabThera
Kako čuvati lijek MabThera
Each vial contains 1400 mg/11.7 mL rituximab.
1 bočica sadrži 1400 mg/11,7 ml rituksimaba.
PFS - Progression-Free Survival (proportion with event, disease progression/relapse or death from any cause) a - at end of Induction b - at time of final analysis (median follow-up 58 months)
Progression-Free Survival) (udio bolesnika s događajem: progresija/relaps bolesti ili smrt zbog bilo kojeg uzroka)
MabThera subcutaneous formulation contains recombinant human hyaluronidase (rHuPH20), an enzyme used to increase the dispersion and absorption of co-administered substances when administered subcutaneously.
(rHuPH20), enzim koji se koristi za povećanje disperzije i apsorpcije istodobno primijenjenih lijekova kada se oni primjenjuju supkutano.
At Week 24, patients who were seropositive to RF and/or anti-CCP at baseline had a significantly increased probability of achieving ACR20 and 50 responses compared to seronegative patients (p=0.0312 and p=0.0096) (Table 15).
ACR50 u usporedbi sa seronegativnim bolesnicima (p = 0,0312 i p = 0,0096) (Tablica 15).
Diluted medicinal product
Razrijeđen lijek
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
Nakon postizanja remisije, a unutar najviše mjesec dana od primjene posljednje pulsne doze ciklofosfamida, bolesnici su bili randomizirani za primanje lijeka MabThera (dvije i.v. infuzije od 500 mg u razmaku od dva tjedna [1. dana i 15. dana], a zatim 500 mg i.v. svakih 6 mjeseci tijekom 18 mjeseci) ili azatioprina (primijenjenog peroralno u dozi od 2 mg/kg na dan tijekom 12 mjeseci, zatim u dozi od 1,5 mg/kg na dan tijekom 6 mjeseci i na kraju u dozi od 1 mg/kg na dan tijekom 4 mjeseca [prekid liječenja nakon ta 22 mjeseca]).
The rate of overall infections and serious infections was not increased after the development of low IgA, IgG or IgM.
Stopa svih infekcija i ozbiljnih infekcija nije se povećala nakon nastupa niskih vrijednosti
Each vial contains 1600 mg/ 13.4 mL rituximab.
1 bočica sadrži 1600 mg/13,4 ml rituksimaba.
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.
Infekcije virusom hepatitisa B U bolesnika s reumatoidnim artritisom, granulomatozom s poliangitisom i mikroskopskim poliangitisom koji su primali lijek MabThera prijavljeni su slučajevi reaktivacije hepatitisa B, uključujući one sa smrtnim ishodom.
The majority of patients had received MabThera in combination with chemotherapy or as part of a haematopoetic stem cell transplant.
Većina je bolesnika primala lijek MabThera u kombinaciji s kemoterapijom ili u sklopu presađivanja hematopoetskih matičnih stanica.
Rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris
Reumatoidni artritis, granulomatoza s poliangitisom, mikroskopski poliangitis i obični pemfigus
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.
Analizom djelotvornosti obuhvaćeno je ukupno 810 bolesnika (403 R-FC, 407 FC) u ispitivanju prve linije liječenja (Tablica 10a i Tablica 10b) i 552 bolesnika (276 R-FC, 276 FC) u ispitivanju relapsirajuće/refraktorne bolesti (Tablica 11).
Complete response (CR/CRu) rate* 48% 67% 53% 67% chi-squared test p value odds ratio (95% CI)
log-rang p-vrijednost omjer hazarda (95% CI) smanjenje rizika Stopa ukupnog odgovora* p-vrijednost iz hi-kvadrat testa omjer izgleda (95% CI) Stopa potpunog odgovora (CR/CRu)* p-vrijednost iz hi-kvadrat testa omjer izgleda (95% CI)
The most common infections in the MabThera group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Najčešće infekcije u skupini koja je primala lijek MabThera bile su herpes simplex i herpes zoster, bronhitis,
The clinical experience of MabThera subcutaneous formulation in Non-Hodgkin's lymphoma is based on data from a phase III clinical trial (SABRINA BO22334) in patients with follicular lymphoma (FL) and a phase Ib dose-finding/dose-confirmation trial (SparkThera BP22333) in patients with FL.
BO22334) u bolesnika s folikularnim limfomom (FL) te ispitivanja faze Ib namijenjenog utvrđivanju/potvrđivanju doze (SparkThera BP22333) u bolesnika s FL-om.
4 see also section infusion-related reactions below.
Vidjeti i dio o reakcijama povezanima s infuzijom u nastavku.
The frequencies of ADRs reported with MabThera alone or in combination with chemotherapy are summarised in Table 1.
Učestalost nuspojava prijavljenih pri primjeni lijeka MabThera u monoterapiji ili u kombinaciji s kemoterapijom sažeta je u Tablici
This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphaetemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
hipokalcijemijom, hiperfosfatemijom, akutnim zatajenjem bubrega, povišenom razinom laktat dehidrogenaze (LDH), kao i s akutnim zatajenjem dišnog sustava i smrću.
Patients achieving at least partial response (PR) were entered on the MabThera subcutaneous formulation maintenance therapy once every 8 weeks for 24 months.
MabThera u formulaciji za supkutanu primjenu jedanput svakih 8 tjedana tijekom 24 mjeseca.
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.
Za vrijeme liječenja u ispitivanjima lijeka MabThera u kombinaciji s kemoterapijom obično su s većom učestalošću u usporedbi s primjenom samo kemoterapije prijavljene: leukopenija stupnja 3/4 (R-CHOP 88% naspram CHOP 79%), neutropenija (R-CVP 24%
NAME OF THE MEDICINAL PRODUCT MabThera 1600 mg solution for subcutaneous injection
NAZIV LIJEKA MabThera 1600 mg otopina za supkutanu injekciju
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 500 mg concentrate for solution for infusion Rituximab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MabThera 500 mg koncentrat za otopinu za infuziju rituksimab i.v.