natgillin/translations-raw huggingface dataset:
The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 1400 mg 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 administrations in total).
Preporučena doza lijeka MabThera u terapiji održavanja u bolesnika s relapsirajućim/refraktornim folikularnim limfomom koji su odgovorili na uvodno liječenje iznosi 375 mg/m površine tijela jedanput svaka 3 mjeseca (počevši 3 mjeseca nakon zadnje doze uvodne terapije) do progresije bolesti ili najdulje dvije godine (ukupno 8 infuzija).
Significant difference from placebo + MTX at the primary timepoint: ***p ≤ 0.0001
† Ishod nakon 24 tjedna Značajna razlika u odnosu na placebo + metotreksat u trenutku primarne mjere ishoda: ***p ≤ 0,0001
NAME OF THE MEDICINAL PRODUCT MabThera 1400 mg solution for subcutaneous injection
NAZIV LIJEKA MabThera 1400 mg otopina za supkutanu injekciju
PML).
(PV).
The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with CLL.
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja rituksimaba u svim podskupinama pedijatrijske populacije s KLL-om.
Subcutaneous injections
infiltracija pluća
MabThera intravenous formulation
MabThera za intravensku primjenu
MabThera 1600 mg solution for subcutaneous injection rituximab
MabThera 1600 mg otopina za supkutanu injekciju rituksimab
MabThera is associated with infusion/administration-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Primjena lijeka MabThera povezuje se s reakcijama na infuziju/primjenu, koje mogu biti povezane s otpuštanjem citokina i/ili drugih kemijskih medijatora.
InSparkThera, no severe administration-related reactions were reported.
Nisu opažene ozbiljne reakcije povezane s infuzijom.
In the clinical trial evaluating MabThera maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the MabThera groups.
IgG-a nakon početne terapije bio je ispod donje granice normalnih vrijednosti (< 7 g/l) i u opservacijskoj skupini i u skupini koja je primala lijek MabThera.
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
Kasnija analiza trajanja ukupnog preživljenja, provedena nakon medijana praćenja od 60 mjeseci, potvrdila je prednost liječenja R-CHOP-om u odnosu na liječenje CHOP-om (p = 0,0071),
The chemotherapy should be given after the MabThera infusion.
Kemoterapiju treba dati nakon infuzije lijeka MabThera.
Very rare cases of PML have been reported during post-marketing use of the MabThera intravenous formulation in NHL (see section 4.8).
Nakon stavljanja formulacije lijeka MabThera za intravensku primjenu u promet prijavljeni su vrlo rijetki slučajevi PML-a u bolesnika s NHL-om (vidjeti dio 4.8).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 100 mg concentrate for solution for infusion Rituximab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MabThera 100 mg koncentrat za otopinu za infuziju rituksimab i.v.
lung infiltration,
gljivična infekcija,
• If you are having MabThera with chemotherapy MabThera will be given to you on the same day as your chemotherapy.
Koliko ćete lijeka primiti i koliko često · Lijek MabThera primit ćete istoga dana kad i kemoterapiju.
cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month timepoint.
U bolesnika s granulomatozom s poliangitisom i mikroskopskim poliangitisom broj perifernih B stanica smanjio se na < 10 stanica/µl nakon dvije tjedne infuzije rituksimaba u dozi od 375 mg/m2 i održao na toj razini u većine bolesnika do trenutka mjere ishoda nakon 6 mjeseci.
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.
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja rituksimaba u svim podskupinama pedijatrijske populacije s folikularnim limfomom.
The percentage of patients reporting ADRs upon re-treatment with further courses of MabThera was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
Postotak bolesnika koji su prijavili nuspojave nakon ponovnog liječenja dodatnim ciklusima lijeka MabThera bio je sličan postotku bolesnika koji su prijavili nuspojave nakon početnog liječenja
For subjects in the middle and low BSA tritiles, average Ctrough values following intravenous dosing were approximately 12% and 26% lower compared to the subcutaneous regimen.
U ispitanika sa srednjom i malom površinom tijela (srednja i donja trećina), prosječne vrijednosti Ctrough nakon intravenske primjene bile su približno
For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Unaprijed utvrđena primarna analiza provedena je nakon medijana promatranja od 25 mjeseci od randomizacije.
MabThera 1400 mg solution for subcutaneous injection rituximab
MabThera 1400 mg otopina za supkutanu injekciju rituksimab
Very Rare
Manje često
• memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare,
- smetenost, gubitak pamćenja ili poteškoće s razmišljanjem
84.9% (n = 174)
Procjena jednim brojem 84,9% (n = 174)
The geometric mean Ctrough (CV%) values at
Geometrijska srednja vrijednost Cthrough (CV%) u 5. ciklusu (prije primjene doze u 6. ciklusu)
Should non-live vaccinations be required whilst receiving MabThera therapy, these should be completed at least 4 weeks prior to commencing the next course of MabThera.
MabThera, ono se mora dovršiti najmanje 4 tjedna prije početka sljedećeg ciklusa lijeka MabThera.
MabThera treatment.
MabThera.
Patients randomised to the MabThera group received an initial 1000 mg IV on Study Day 1 and a second 1000 mg IV on Study Day 15.
1000 mg i.v. na 1. dan ispitivanja i drugu dozu od 1000 mg i.v. na 15. dan ispitivanja.
Initial treatment, bulky disease, weekly for 4 doses In pooled data from three trials, 39 patients with relapsed or chemoresistant, bulky disease (single lesion ≥ 10 cm in diameter), low grade or follicular B cell NHL received 375 mg/m2 of MabThera as intravenous infusion weekly for four doses.
Početno liječenje, jedanput tjedno tijekom 4 tjedna U pivotalnom je ispitivanju 166 bolesnika s relapsirajućim ili kemorezistentnim, nisko malignim ili folikularnim B-staničnim ne-Hodgkinovim limfomom primilo lijek MabThera u dozi od 375 mg/m2
METHOD OF ADMINISTRATION Only for subcutaneous use
Samo za supkutanu primjenu
You might get infections more easily during your treatment with MabThera.
Tijekom liječenja lijekom MabThera možda ćete biti podložniji infekcijama.
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).
Preporučena doza lijeka MabThera u formulaciji za supkutanu primjenu u terapiji održavanja u bolesnika s prethodno neliječenim folikularnim limfomom koji su odgovorili na uvodno liječenje iznosi: 1400 mg jedanput svaka 2 mjeseca (počevši 2 mjeseca nakon zadnje doze indukcijske terapije)
Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with MabThera.
zaušnjaci, rubela, varičela) prije terapije održala se najmanje 6 mjeseci nakon liječenja lijekom
The cumulative incidence rate curves showed that time to first major relapse was longer in patients with MabThera starting from month 2 and was maintained up to month 28 (Figure 3).
Krivulje kumulativne stope incidencije pokazuju dulje vrijeme do prvog teškog relapsa u bolesnika liječenih lijekom MabThera.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 1600 mg solution for subcutaneous injection Rituximab subcutaneous
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MabThera 1600 mg otopina za supkutanu injekciju rituksimab supkutano
Experience from granulomatosis with polyangiitis and microscopic polyangiitis
Iskustva s primjenom kod granulomatoze s poliangitisom i mikroskopskog poliangitisa Poticanje remisije
Vascular disorders Hypertension
Pretrage snižene razine hemoglobina
Keep the container in the outer carton, in order to protect from light
Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti
MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
MabThera je u kombinaciji s kemoterapijom indicirana u liječenju bolesnika oboljelih od folikularnog limfoma stadija III-IV koji prethodno nisu liječeni.
What MabThera 1600 mg solution for subcutaneous injection looks like and contents of the pack
Što MabThera 1600 mg otopina za supkutanu injekciju sadrži · Djelatna tvar je rituksimab.
Mean pre-therapeutic antibody titers against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella and varicella) were maintained for at least 6 months after treatment with MabThera.
zaušnjaci, rubela i varičela) prije terapije održala se najmanje 6 mjeseci nakon liječenja lijekom
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 1400 mg solution for subcutaneous injection Rituximab subcutaneous
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MabThera 1400 mg otopina za supkutanu injekciju rituksimab supkutano
3Infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythema)
hipotenzija, rinitis, tresavica, tahikardija, umor, bol u ustima i ždrijelu, periferni edem, eritem)
Muscle weakness
ANCA vaskulitisom.
• Pain without injuring yourself
· gubitak tjelesne težine · bol koja nije posljedica ozljede
• headache
• omaglica
Package leaflet: Information for the patient
Kartica sadrži važne informacije o sigurnosti za bolesnike,
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
Tablica 3 Liječenje relapsirajuće/refraktorne kronične limfocitne leukemije - pregled rezultata djelotvornosti za lijek MabThera
CRR
ORR
Pneumocystis jirovecii pneumonia prophylaxis was required for all patients with CD4+ T-lymphocyte counts less than 250 per cubic millimeter.
T-limfocita bio manji od 250/mm3 morali su primati profilaksu za pneumoniju koju uzrokuje
This is because some people have a fall in their blood pressure while they are being given MabThera.
12 sati prije primjene lijeka MabThera zato što nekim bolesnicima može pasti krvni tlak tijekom primjene lijeka MabThera.
In a multi-centre, single-arm trial, 58 patients with relapsed or chemoresistant low grade or follicular B cell NHL, who had achieved an objective clinical response to a prior course of MabThera, were re-treated with 375 mg/m2 of MabThera as intravenous infusion weekly for four doses.
B-staničnim ne-Hodgkinovim folikularnim limfomom ili limfomom niskog stupnja malignosti, u kojih je postignut očekivan klinički odgovor na prethodno liječenje lijekom MabThera, ponovno liječeno lijekom MabThera u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom četiri tjedna.
Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of MabThera as a single agent or in combination with CHOP therapy (applied MabThera doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
MabThera bile su u rasponu od 100 do 500 mg/m2), procjene za tipičnu populaciju bolesnika bile su: za nespecifični klirens (CL1) 0,14 l/dan, specifični klirens (CL2) kojemu su vjerojatno pridonijele
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
Tablica 11 Liječenje relapsirajuće/refraktorne kronične limfocitne leukemije - pregled rezultata djelotvornosti za lijek MabThera
Very rare cases of PML have been reported during post-marketing use of the MabThera intravenous formulation in CLL (see section 4.8).
Nakon stavljanja formulacije lijeka MabThera za intravensku primjenu u promet prijavljeni su vrlo rijetki slučajevi PML-a u bolesnika s KLL-om (vidjeti dio 4.8).
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
+ FC u odnosu na samo FC (medijan vremena promatranja je 48,1 mjesec) Parametar djelotvornosti
Nasopharyngitis
Ciklofosfamid
where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
U kliničkim ispitivanjima nisu zabilježene reakcije povezane s infuzijom 4. stupnja prema općim kriterijima toksičnosti (engl.
• MabThera subcutaneous (n= 88); 1st cycle of MabThera intravenous 375 mg/m2 in combination with chemotherapy plus subsequent cycles (2-6) of MabThera subcutaneous 1600mg in combination with chemotherapy.
Ukupno je 176 bolesnika s KLL-om bilo randomizirano u sljedeće dvije terapijske skupine: · MabThera u formulaciji za supkutanu primjenu (n=88): u 1. ciklusu primjenjivala se intravenska formulacija lijeka MabThera u dozi od 375 mg/m2 u kombinaciji s kemoterapijom, a zatim se u sljedećim ciklusima (2. - 6.) primjenjivala formulacija lijeka MabThera za supkutanu primjenu u dozi od 1600 mg u kombinaciji s kemoterapijom. · MabThera u formulaciji za intravensku primjenu (n=88): u 1. ciklusu primjenjivala se intravenska formulacija lijeka MabThera u dozi od 375 mg/m2 u kombinaciji s kemoterapijom,
Musculoskeletal and connective tissue disorders
Poremećaji krvi i limfnog sustava trombocitopenija
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).
Stevens-Johnsonova sindroma, neke od njih sa smrtnim ishodom (vidjeti dio 4.8).
In a prospective, open label, international, multi-center, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
R-CHOP-om (n = 881), R-CVP-om (n = 268) ili R-FCM-om (n = 44) prema odabiru ispitivača.
Herpes zoster
kožni papilom
MabThera is used for the treatment of patients with moderate to severe pemphigus vulgaris.
MabThera je indicirana za liječenje bolesnika s umjerenim do teškim oblikom običnog pemfigusa
The overall incidence of IRRs in clinical trials was 23% with the first infusion and decreased with subsequent infusions.
Ukupna incidencija reakcija povezanih s infuzijom u kliničkim ispitivanjima bila je 23%
The recommended dose is: first cycle, MabThera intravenous formulation: 375 mg/m2 body surface area, followed by subsequent cycles with MabThera subcutaneous formulation injected at a fixed dose of 1400 mg per cycle.
375 mg/m2 površine tijela, a zatim se u sljedećim ciklusima injicira formulacija lijeka MabThera za supkutanu primjenu u fiksnoj dozi od 1400 mg po ciklusu, tijekom ukupno 8 ciklusa.
In the pivotal trial, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/m2 of MabThera as an intravenous infusion once weekly for four weeks.
B-staničnim ne-Hodgkinovim folikularnim limfomom ili limfomom niskog stupnja malignosti primilo je lijek MabThera u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom osam tjedana.
• diarrhoea
· mučnina
IgG levels
Pretrage smanjene razine IgG-a
Laboratory evaluations
Laboratorijski nalazi
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 %.
Kaplan-Meierovoj procjeni, medijan preživljenja bez događaja iznosio je 35 mjeseci za R-CHOP
Dyspnoea
Imunogenost
by Q4 2019 (preliminary CSR) by Q4 2020 (final CSR)
do 4. tromjesečja 2019. (preliminarno izvješće o kliničkom ispitivanju
Arthralgia
omaglica
Premedication consisting of an analgesic/antipyretic and an antihistamine should always be administered before each dose of MabThera subcutaneous formulation.
Prije svake doze formulacije lijeka MabThera za supkutanu primjenu treba uvijek primijeniti premedikaciju koja se sastoji od jednog analgetika/antipiretika i jednog antihistaminika.
• infections, such as chest infections, urinary tract infections (pain on passing water), colds and herpes infections
· infekcije krvi (sepsa), upala pluća, herpes zoster, prehlada, infekcije bronha, gljivične infekcije,
The benefit of MabThera maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (table 6).
ND: nije dostignuto; a: primjenjivo samo u bolesnika koji su postigli CR Korist od terapije održavanja lijekom MabThera potvrđena je u svim analiziranim podskupinama neovisno o uvodnom režimu liječenja (CHOP ili R-CHOP) i kvaliteti odgovora na indukcijsko liječenje (CR ili PR) (Tablica 6).
In the majority of these cases, MabThera was administered with chemotherapy.
MabThera je primijenjena u kombinaciji s kemoterapijom.
In a multi-centre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of MabThera as intravenous infusion weekly for eight doses.
U objedinjenim podacima iz tri ispitivanja 39 bolesnika s relapsirajućim ili kemorezistentnim proširenim ne-Hodgkinovim limfomom (promjer jedne lezije ≥ 10 cm) niskog stupnja malignosti ili folikularnim B-staničnim ne-Hodgkinovim limfomom je primilo lijek MabThera u dozi od 375 mg/m2
The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
U prijavljenim slučajevima postojali su faktori rizika za PRES/RPLS, uključujući osnovnu bolest bolesnika,
Events of neutropenia were observed with MabThera treatment, the majority of which were transient and mild or moderate in severity.
Tijekom liječenja lijekom MabThera zabilježeni su slučajevi neutropenije koji su većinom bili prolazni te blagog do umjerenog intenziteta.
Infusion/Administration-related reactions
Reakcije na infuziju/primjenu
MabThera intravenous
MabThera intravenski
The benefit of MabThera maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (Table 9).
ND: nije dostignuto; a: primjenjivo samo u bolesnika koji su postigli CR Korist od terapije održavanja lijekom MabThera potvrđena je u svim analiziranim podskupinama neovisno o uvodnom režimu liječenja (CHOP ili R-CHOP) i kvaliteti odgovora na uvodno liječenje (CR ili PR) (Tablica 9).
• severe skin problems causing blisters that can be life-threatening
· oštećenje stijenke crijeva (perforacija) · teški problemi s kožom uz stvaranje mjehurića na koži koji mogu biti opasni po život
In clinical trials fewer than 1% (17/3189) of patients experienced a serious IRR.
(17/3189) bolesnika u kliničkim ispitivanjima imalo je ozbiljnu reakciju povezanu s infuzijom.
Based on popPK analysis of study BO25341 (SAWYER) an absolute bioavailability of 68.4% was estimated.
Na temelju populacijske farmakokinetičke analize podataka iz ispitivanja BO25341 (SAWYER)
When you are treated with MabThera in combination with chemotherapy, you will receive a MabThera infusion on day 0 of cycle 1, then subcutaneous injections on day 1 of each subsequent cycle.
MabThera nultog dana prvog ciklusa, a zatim supkutanu injekciju prvog dana svakog sljedećeg ciklusa tijekom ukupno 6 ciklusa.
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
Preporučena doza lijeka MabThera u kombinaciji s kemoterapijom za uvodno liječenje bolesnika s prethodno neliječenim ili relapsirajućim/refraktornim folikularnim limfomom iznosi 375 mg/m2
The chemotherapy should be given after MabThera administration.
Kemoterapiju treba dati nakon primjene lijeka MabThera.
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).
750 mg/m2, vinkristin 1,4 mg/m2 do najviše 2 mg prvog dana liječenja, prednizolon 40 mg/m2/dan od prvog do petog dana liječenja) svaka 3 tjedna u 8 ciklusa liječenja, ili lijeka MabThera u dozi od
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use only
NAČIN I PUT(EVI) PRIMJENE LIJEKA
MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/067/002
migraine, dizziness
• nemir, teškoće s usnivanjem
Number of patients
U populaciji bolesnika
In the overall experience of MabThera repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
S. pneumoniae, influence, zaušnjaka, rubele, varičele i toksoida tetanusa općenito bili slični udjelima na početku liječenja.
MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/067/004
The recommended dosage is 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP.
tjelesne površine, a primjenjuje se prvog dana svakog ciklusa kemoterapije nakon intravenske infuzije glukokortikoidne komponente CHOP-a, tijekom 8 ciklusa.
In a prospective, open label, international, multi-centre, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
U prospektivnom, otvorenom, međunarodnom, multicentričnom ispitivanju faze III 1193 bolesnika s prethodno neliječenim uznapredovalim folikularnim limfomom primalo je indukcijsku terapiju
The
a
Cases of progressive multifocal leukoencephalopathy with fatal outcome have been reported following use of MabThera for the treatment of autoimmune diseases.
Nakon primjene lijeka MabThera u liječenju autoimunih bolesti prijavljeni su slučajevi progresivne multifokalne leukoencefalopatije sa smrtnim ishodom.
MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion rituximab
Uputa o lijeku: Informacije za bolesnika MabThera 100 mg koncentrat za otopinu za infuziju MabThera 500 mg koncentrat za otopinu za infuziju rituksimab
MARKETING AUTHORISATION NUMBER(S) EU/1/98/067/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/067/001