natgillin/translations-raw huggingface dataset:
The ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
ORR je iznosio 57 % (95 % CI 41 % - 73 %; CR 14 %, PR 43 %), a procijenjeni medijan TTP-a u bolesnika koji su odgovorili na liječenje bio je 19,4 mjeseci (raspon od 5,3 do 38,9 mjeseci).
Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite ovaj lijek ako ste Vi ili
The pre-specified primary analysis was conducted at a median observation time of 25 months from randomisation, maintenance therapy with rituximab resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progressionfree survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Unaprijed utvrđena primarna analiza provedena je nakon medijana promatranja od 25 mjeseci od randomizacije terapija održavanja rituksimabom u bolesnika s prethodno neliječenim folikularnim limfomom dovela je do klinički i statistički značajnog poboljšanja u primarnoj mjeri ishoda, tj.
Following second infusion, mean Cmax ranged from 183 to 198 μg/mL for the 2 × 500 mg dose and ranged from 355 to 404 μg/mL for the 2 × 1000 mg dose.
Nakon druge se infuzije prosječni Cmax kretao između 183 i 198 µg/ml pri dozi od 2 x 500 mg, odnosno između 355 i 404 µg/ml pri dozi od 2 x 1000 mg.
Read the leaflet for further information.
Za više informacija pročitajte uputu o lijeku.
Gastrointestinal disorders dyspepsia, diarrhoea, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain
Poremećaji probavnog sustava dispepsija, proljev, gastroezofagealni refluks, vrijed usta, bol u gornjem abdomenu
Rituximab, administered as an intravenous infusion at a dose of 375 mg/m2 at weekly intervals for 4 doses to 203 patients with NHL naive to rituximab, yielded a mean Cmax following the fourth infusion of 486 µg/mL (range, 77.5 to 996.6 µg/mL).
Srednja vrijednost Cmax nakon četvrte intravenske infuzije rituksimaba u dozi od 375 mg/m2, u razmacima od tjedan dana u 203 bolesnika s NHL-om koji prethodno nisu primali rituksimab, iznosila je 486 µg/ml (raspon od 77,5 do 996,6 µg/ml).
Thrombocytopenia
Ciklofosfamid
Your doctor may decide to treat you longer with Ritemvia (up to 5 years), depending on how you respond to the medicine.
Ovisno o tome kako odgovorite na lijek, liječnik će Vam možda produljiti liječenje lijekom Ritemvia (do 5 godina).
The proportion of CTC Grade 3 events, and of IRRs leading to withdrawal decreased by course and were rare from course 3 onwards.
3. stupnja prema CTC kriterijima i reakcija povezanih s infuzijom koje su dovele do prekida liječenja smanjivao se nakon svakog ciklusa i takvi su događaji bili su rijetki od 3. ciklusa nadalje.
The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group．
log-rang test stratificiran prema centru): stope preživljenja nakon 53 mjeseca bile su 80,9 % za bolesnike u R-CVP skupini, u usporedbi sa 71,1 % za bolesnike u CVP skupini.
Contraindications for use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section 6.1.
Kontraindikacije za primjenu kod reumatoidnog artritisa, granulomatoze s poliangiitisom mikroskopskog poliangiitisa i običnog pemfigusa Preosjetljivost na djelatnu tvar, mišje proteine ili neku od ostalih pomoćnih tvari navedenih u dijelu 6.1.
Experience from rheumatoid arthritis
Iskustva s primjenom u reumatoidnom artritisu
Mean terminal elimination half-life ranged from 15 to 16 days for the 2 × 500 mg dose group and 17 to 21 days for the 2 × 1000 mg dose group.
Srednje terminalno poluvrijeme eliminacije iznosilo je od 15 do 16 dana u skupini koja je primala dozu od 2 x 500 mg te 17 do 21 dan u skupini koja je primala dozu od 2 x 1000 mg.
The reactions reported were usually reversible with a reduction in rate, or interruption, of rituximab infusion and administration of an anti-pyretic, an antihistamine, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Prijavljene reakcije obično su se povukle nakon smanjenja brzine infuzije ili prekida infuzije rituksimaba te primjene antipiretika, antihistaminika i povremeno kisika, intravenske primjene fiziološke otopine ili bronhodilatatora te, po potrebi, glukokortikoida.
Patients in both arms received 1000 mg of pulse intravenous (IV) methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Bolesnici u obje skupine su tijekom 1 do 3 dana primali pulsnu intravensku (i.v.) terapiju metilprednizolonom u dozi od 1000 mg na dan (ili drugi glukokortikoid u ekvivalentnoj dozi), a zatim peroralni prednizon (1 mg/kg na dan, ali ne više od 80 mg na dan).
This medicinal product contains 52.6 mg sodium per 10 mL vial, equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.For the full list of excipients, see section 6.1.
Pomoćne tvari s poznatim učinkom: Ovaj lijek sadrži 52,6 mg natrija po bočici od 10 mL, što odgovara 2,6% maksimalnog dnevnog unosa od 2g natrija prema preporukama SZO za odraslu osobu.
Localised candida infections as well as Herpes zoster were reported at a higher incidence in the rituximab-containing arm of randomised studies.
Lokalizirane infekcije kandidom te herpes zoster u randomiziranim su ispitivanjima prijavljeni s većom incidencijom u skupinama koje su primale rituksimab.
The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/ m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
iznosio je 408 µg/ml (raspon 97-764 µg/ml), dok je prosječan terminalni poluvijek bio 32 dana (raspon
Clinical experience in granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
Klinička iskustva u liječenju granulomatoze s poliangiitisom (Wegenerova granulomatoza) i mikroskopskog poliangiitisa
Metabolism and nutrition disorders hyperglycaemia , weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Poremećaji metabolizm a i prehrane hiperglikemija, smanjenje težine, periferni edem, edem lica,
Structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
Strukturno oštećenje zglobova procijenjeno je radiološki i iskazano kao promjena u prilagođenom ukupnom rezultatu na Sharpovoj ljestvici (engl.
The infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections and urinary tract infections.
Infekcije su većinom bile blage do umjerene i uglavnom infekcije gornjih dišnih i mokraćnih puteva.
Re-treatment, weekly for 4 doses
Ponovno liječenje, jedanput tjedno tijekom 4 tjedna
There are no data on the safety of rituximab in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
Nema podataka o sigurnosti lijeka rituksimaba u bolesnika s umjerenim zatajenjem srca (NYHA
Adverse drug reaction rituximab + low-dose prednisone (n=38)
Ritukximab + niska doza prednizona (n = 38)
Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Prijavljeni su slučajevi sindroma reverzibilne posteriorne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES) odnosno sindroma reverzibilne posteriorne leukoencefalopatije (engl. reversible posterior leukoencephalopathy syndrome, RPLS).
No patients in the rituximab arm had fatal adverse events.
Ni u jednog bolesnika u skupini koja je primala lijek rituksimab nije zabilježen štetni događaj sa smrtnim ishodom.
Higher frequencies of infections overall, including grade 3 or 4 infections, were observed during rituximab maintenance treatment up to 2 years when compared to observation.
Tijekom terapije održavanja rituksimabom u trajanju do 2 godine primijećena je veća sveukupna učestalost infekcija, uključujući infekcije stupnja 3 i 4, u usporedbi s opservacijskom skupinom.
This medicinal product contains 263.2 mg sodium per 50 mL vial, equivalent to 13.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.For the full list of excipients, see section 6.1.
Pomoćne tvari s poznatim učinkom: Ovaj lijek sadrži 263,2 mg natrija po bočici od 50 mL, što odgovara 13,2% maksimalnog dnevnog unosa od 2g natrija prema preporukama SZO za odraslu osobu.
Relapsed/Refractory follicular lymphoma
Folikularni limfom u relapsu/refraktorni folikularni limfom
Urinary tract infection Bronchitis
Infekcije i infestacije bronhitis rinitis
Vascular disorders hypertension, orthostatic hypotension, hypotension vasculitis (predominate ly cutaneous), leukocytoclas tic vasculitis
Krvožilni poremećaji hipertenzija, ortostatska hipotenzija, hipotenzija vaskulitis (pretežno kutani),
Response rate and CR rates analysed using Chi-squared Test. NR: not reached; N/A: not applicable *: only applicable to patients achieving a CR, nPR, PR **: only applicable to patients achieving a CR
ND: nije dostignuto; n.p.: nije primjenjivo *: primjenjivo samo za bolesnike koji su postigli CR, nPR ili PR **: primjenjivo samo za bolesnike koji su postigli CR
Adverse event
Udio događaja
Initial treatment, weekly for 4 doses
Početno liječenje, jedanput tjedno tijekom 4 tjedna
Significant reductions in disability index (HAQ-DI) and fatigue (FACIT-Fatigue) were observed in patients treated with rituximab compared to patients treated with methotrexate alone.
Functional Assessment of Chronic Illness Therapy - Fatigue, FACIT-Fatigue) u odnosu na bolesnike liječene samo metotreksatom.
3infusion related reactions (generalised oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction)
3reakcije povezane s infuzijom (generalizirani edem, bronhospazam, piskanje, edem larinksa, angioneurotski edem, opći svrbež,
Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins to patients.
Nakon intravenske primjene proteina bolesnicima prijavljene su anafilaktičke i druge reakcije preosjetljivosti.
Each mL of concentrate contains 10 mg of rituximab.
Jedan ml koncentrata sadrži 10 mg rituksimaba.
Infections and infestations bacterial infection, viral infections, +bronchitis sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
Infekcije i infestacije bakterijske infekcije, virusne infekcije, +bronhitis sepsa, +upala pluća, +febrilna infekcija, +herpes zoster, +infekcija dišnog sustava,
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).
Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 × 500 mg dose and 317 to 370 μg/mL for 2 × 1000 mg dose.
Prosječni Cmax rituksimaba u serumu nakon prve infuzije bio je 170 do 175 µg/ml pri dozi od 2 x 500 mg, odnosno 317 do 370 µg/ml pri dozi od 2 x 1000 mg.
The two treatment groups were well balanced with regards to baseline characteristics and disease status.
Dvije liječene skupine bile su dobro uravnotežene u pogledu početnih karakteristika i stanja bolesti.
• heart failure
+srčani poremećaj
These symptoms are usually reversible with interruption of rituximab infusion and administration of an anti-pyretic, an antihistaminic and occasionally oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Ti se simptomi obično povlače nakon prekida infuzije rituksimaba i primjene antipiretika, antihistaminika te ponekad kisika, intravenske primjene fiziološke otopine ili bronhodilatatora te po potrebi glukokortikoida.
At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, patients were randomly assigned to receive either rituximab (two 500 mg IV infusions separated by two weeks (on Day 1 and Day 15) followed by 500 mg IV every 6 months for 18 months) or azathioprine (administered orally at a dose of 2 mg/kg/day for 12 months, then 1.5 mg/kg/day for 6 months, and finally 1 mg/kg/day for 4 months (treatment discontinuation after these 22 months)).
Nakon postizanja remisije, a unutar najviše mjesec dana od primjene posljednje pulsne doze ciklofosfamida, bolesnici su bili randomizirani za primanje lijeka rituksimab (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]).
Previously untreated follicular lymphoma
Prethodno neliječeni folikularni limfom
Patients randomised to the rituximab group received an initial intravenous infusion of 1000 mg rituximab on Study Day 1 in combination with 0.5 mg/kg/day oral prednisone tapered off over 3 months if they had moderate disease or 1 mg/kg/day oral prednisone tapered off over 6 months if they had severe disease, and a second intravenous infusion of 1000 mg on Study Day 15.
Bolesnici randomizirani u skupinu liječenu lijekom rituksimab primili su početnu intravensku infuziju lijeka rituksimab u dozi od 1000 mg na 1. dan ispitivanja te su primali prednizon u peroralnoj dozi od 0,5 mg/kg na dan, koja se postupno smanjivala tijekom 3 mjeseca ako su imali umjerenu bolest, odnosno u peroralnoj dozi od 1 mg/kg na dan, koja se postupno smanjivala tijekom 6 mjeseci ako su imali tešku bolest.
log-rank p value hazard ratio (95% CI) risk reduction TNCT (median)
log-rang p-vrijednost omjer hazarda (95% CI) smanjenje rizika TNCT (medijan)
Cmax following second infusion, was 207 μg/mL for the 2 × 500 mg dose and ranged from 377 to 386 μg/mL for the 2 × 1000 mg dose.
Nakon druge infuzije vrijednost Cmax iznosila je 207 µg/ml pri dozi od 2 x 500 mg te 377 do 386 µg/ml pri dozi od 2 x 1000 mg.
a) Non-Hodgkin's Lymphoma
a) ne-Hodgkinova limfoma
Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients from clinical study up to month 24
Tablica 5 Nuspojave zabilježene u bolesnika s običnim pemfigusom liječenih lijekom rituksimab u kliničkom ispitivanju do 24. mjeseca
The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with rituximab, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following rituximab therapy.
Dostupni podaci pokazuju da je stopa klinički značajnih infekcija nepromijenjena kada se ti lijekovi primjenjuju u bolesnika koji su prethodno liječeni rituksimabom.
Pneumocystis jirovecii pneumonia prophylaxis was required for all patients with CD4+ T-lymphocyte counts less than 250 per cubic millimeter.
Svi bolesnici u kojih je broj CD4+ Tlimfocita bio manji od 250/mm3 morali su primati profilaksu za pneumoniju koju uzrokuje
b) Granulomatosis with polyangiitis or microscopic polyangiitis
b) granulomatoze s poliangiitisom ili mikroskopskog poliangiitisa
Patient information
Informacije za liječnike
The recommended dose of Ritemvia used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area 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 infusions in total).
Preporučena doza lijeka Ritemvia u terapiji održavanja u bolesnika s prethodno neliječenim folikularnim limfomom koji su odgovorili na uvodno liječenje iznosi 375 mg/m2 površine tijela jedanput svaka 2 mjeseca (počevši 2 mjeseca nakon zadnje doze uvodne terapije) do progresije bolesti ili najdulje dvije godine (ukupno 12 infuzija).
Cytokine release syndrome
Poremećaji imunološkog sustava sindrom otpuštanja citokina
Gastrointestin al disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intesti nal perforation7
proljev, bol u abdomenu, disfagija, stomatitis, konstipacija, dispepsija, anoreksija, iritacija grla povećanje abdomena gastrointestinalna perforacija7
+left ventricular failure, +supraventricular tachycardia, +ventricular severe cardiac disorders4 and 6
+zatajenje lijeve klijetke, +supraventrikularn a tahikardija, +ventrikularna tahikardija, +angina, +ishemija miokarda, bradikardija teški srčani poremećaji4 i zatajenje srca4 i 6
At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32%.
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), što predstavlja smanjenje rizika za 32 %.
Event-free survival (median)
Event Free Survival)
Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with rituximab.
U bolesnika liječenih rituksimabom pojavljivali su se angina pektoris, srčane aritmije poput undulacije i fibrilacije atrija, zatajenje srca i/ili infarkt miokarda.
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 rituximab as intravenous infusion weekly for four doses.
Početno liječenje, prošireni tumor, jedanput tjedno tijekom 4 tjedna 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 rituksimab u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom četiri tjedna.
Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 μg/mL for 2 × 500 mg dose and ranged from 298 to 341 μg/mL for 2 × 1000 mg dose.
Prosječni Cmax rituksimaba u serumu nakon prve infuzije kretao se između 157 i 171 µg/ml pri dozi od 2 x 500 mg, odnosno između 298 i 341 µg/ml pri dozi od 2 x 1000 mg.
Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Na temelju populacijske farmakokinetičke analize podataka za 97 bolesnika s s granulomatozom s poliangiitisom i mikroskopskim poliangiitisom koji su primali rituksimab u dozi od 375 mg/m2
Musculoskelet al, connective tissue and bone disorders hypertonia, myalgia, arthralgia, back pain, neck pain, pain
Poremećaji mišićno-koš tanog sustava i vezivnog tkiva hipertonija, mialgija, artralgija, bol u leđima, bol u vratu, bol
Nervous system disorders
Poremećaji živčanog sustava omaglica tremor
Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab 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 rituksimaba ne preporučuje se u bolesnika koji prethodno nisu bili liječeni metotreksatom jer nije utvrđen povoljan omjer koristi i rizika.
Clinical experience in non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Klinička iskustva u liječenju ne-Hodgkinova limfoma i kronične limfocitne leukemije
Toxicity studies in cynomolgus monkeys have shown no other effect than the expected pharmacological depletion of B cells in peripheral blood and in lymphoid tissue.
Ispitivanja toksičnosti na Cynomolgus majmunima nisu pokazala druge učinke osim očekivane farmakološke deplecije
• recurrence of a previous Hepatitis B infection c) If you are being treated for pemphigus vulgaris
povratak ranije hepatitis B infekcije c) Bolesnici koji se liječe od običnog pemfigusa
See also infusion-related reactions below.
Vidjeti i dio o reakcijama povezanima s infuzijom u nastavku.
Infusion related reactions2 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.
Ozljede, trovanja i proceduralne komplikacije reakcije povezane s infuzijom2 Događaji su se smatrali nuspojavama lijeka tek nakon što je provedena temeljita ocjena i utvrđena barem razumna mogućnost uzročne povezanosti između lijeka i štetnog događaja.
The recommended dose of Ritemvia used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 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).
Preporučena doza lijeka Ritemvia u terapiji održavanja u bolesnika s relapsirajućim/refraktornim folikularnim limfomom koji su odgovorili na uvodno liječenje iznosi 375 mg/m2 površine tijela jedanput svaka 3 mjeseca (počevši 3 mjeseca nakon zadnje doze uvodne terapije) do progresije bolesti ili najdulje dvije godine (ukupno 8 infuzija).
Treatment difference (Rituximab --cyclophosphamide)
(rituksimab- ciklofosfamid)
In a prospective, open label, international, multicentre, phase III trial, 465 patients with relapsed/refractory follicular lymphoma were randomised in a first step to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone; n=231) or rituximab plus CHOP (R-CHOP, n=234).
U prospektivnom, otvorenom, međunarodnom, multicentričnom kliničkom ispitivanju faze III, 465 bolesnika s relapsirajućim/refraktornim folikularnim limfomom randomizirano je u prvom koraku u skupinu koja je primala početno liječenje CHOP-om (ciklofosfamid, doksorubicin, vinkristin,
And
i
Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with rituximab.
Sve bolesnike mora se prije početka liječenja lijekom rituksimaba testirati na virus hepatitisa B (HBV).
Each course of treatment is made up of two separate infusions which are given 2 weeks apart.
Bolesnici koji se liječe od običnog pemfigusa Svaki se ciklus liječenja sastoji od dvije zasebne infuzije koje se daju u razmaku od 2 tjedna.
Diffuse large B cell non-Hodgkin's lymphoma
Difuzni ne-Hodgkinov limfom velikih B-stanica
Clinically and statistically significant improvement was also noted on all individual components of the ACR response (tender and swollen joint counts, patient and physician global assessment, disability index scores (HAQ), pain assessment and C-Reactive Proteins (mg/dL).
Health Assessment Questionnaire, HAQ), procjena boli i vrijednosti C-reaktivnog proteina (mg/dl).
The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Kartica sadrži važne informacije o sigurnosti za bolesnike,