natgillin/translations-raw huggingface dataset:
The incidence of all grade infections was similar between the arms.
Incidencija infekcija svih stupanja težine bila je slična u obje liječene skupine.
Consultation with a Neurologist should be considered as clinically indicated.
Ako je klinički indicirano, valja razmotriti konzultaciju s neurologom.
Interstitial lung disease7
hipoksija intersticijska bolest pluća7
Patients treated with Rixathon must be given the patient alert card with each infusion.
Bolesnici koji se liječe lijekom Rixathon moraju kod svake infuzije dobiti karticu s upozorenjima za bolesnika.
• Periodic safety update reports (PSUR)
• Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
7 includes fatal cases
7 Obuhvaća slučajeve sa smrtnim ishodom.
Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences.
koje predstavlja glikozilirani imunoglobulin s konstantnim regijama ljudskog IgG1 i varijabilnim nizovima mišjih lakih i teških lanaca.
Medicinal products for the treatment of hypersensitivity reactions, e.g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of rituximab.
Lijekovi za liječenje reakcija preosjetljivosti, kao što su epinefrin (adrenalin), antihistaminici i glukokortikoidi, moraju biti dostupni za brzu primjenu u slučaju alergijske reakcije tijekom primjene rituksimaba.
Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal products 12 hours prior to the Rixathon infusion.
Budući da tijekom infuzije rituksimaba može doći do hipotenzije, treba razmotriti mogućnost izostavljanja antihipertenzivnih lijekova 12 sati prije primjene infuzije lijeka Rixathon.
The chemotherapy should be given after the Rixathon infusion.
Kemoterapiju treba dati nakon infuzije lijeka Rixathon.
Neutropenia1
Nuspojava1
For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Za bolesnike randomizirane u fazu održavanja u ovom ispitivanju medijan vremena promatranja bio je
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 - 49 days).
Na temelju populacijske farmakokinetičke analize podataka za 97 bolesnika s s granulomatozom s poliangitisom i mikroskopskim poliangitisom koji su primali rituksimab u dozi od 375 mg/m2 jedanput tjedno tijekom četiri tjedna, procijenjen medijan terminalnog poluvremena eliminacije bio je 23 dana
Table 2 Summary of ADRs reported in clinical trials or during postmarketing surveillance occurring in patients with rheumatoid arthritis receiving rituximab System Organ Class
Tablica 2 Sažetak nuspojava prijavljenih u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet u bolesnika s reumatoidnim artritisom koji su primali rituksimab
The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the rituximab group and at a higher frequency than the comparator group.
Nuspojave navedene u Tablici 3 su sve nuspojave koje su se pojavile s incidencijom od ≥ 5 % u skupini koja je primala rituksimab i s većom učestalošću nego u usporednoj skupini.
Table 7 Overview of efficacy results for rituximab maintenance vs. observation at the protocol-defined primary analysis and after 9 years median follow-up (final analysis)
Pregled rezultata djelotvornosti terapije održavanja rituksimabom u odnosu na opservacijsku skupinu u primarnoj analizi prema planu ispitivanja i nakon medijana od 9 godina praćenja (završna analiza)
The safety profile of rituximab in combination with short-term, low-dose glucocorticoids in the treatment of patients with pemphigus vulgaris was studied in a Phase 3, randomised, controlled, multicenter, open-label study in pemphigus patients that included 38 pemphigus vulgaris (PV) patients randomised to the rituximab group.
Sigurnosni profil rituksimaba u kombinaciji s kratkoročnom terapijom niskom dozom glukokortikoida u liječenju bolesnika s običnim pemfigusom ispitivao se u randomiziranom, kontroliranom, multicentričnom, otvorenom ispitivanju faze 3 među bolesnicima s pemfigusom, u kojem je 38 bolesnika s običnim pemfigusom (PV) bilo randomizirano u skupinu liječenu rituksimabom.
• Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heartbeat, and tiredness
• promjene krvnog tlaka, mučnina, osip, vrućica, svrbež, curenje iz nosa ili začepljen nos te kihanje, tresavica, ubrzano kucanje srca i umor • glavobolja
The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with rituximab 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).
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. preživljenju bez progresije bolesti (PFS) prema procjeni ispitivača, u usporedbi s opservacijskom skupinom (Tablica 7).
The alert card contains important safety information for patients regarding potential increased risk of infections, including progressive multifocal leukoencephalopathy (PML).
vezane uz potencijalno povećani rizik od infekcija, uključujući progresivnu multifokalnu leukoencefalopatiju (PML).
• Pain in the tummy, back, muscles and/or joints
• bol u trbuhu, leđima, mišićima i/ili zglobovima
Rituximab (n=57)
Rituksimab (n = 57)
▼This medicinal product is subject to additional monitoring.
▼Ovaj je lijek pod dodatnim praćenjem.
The recommended dosage of Rixathon for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Preporučena doza lijeka Rixathon za poticanje remisije granulomatoze s poliangitisom i mikroskopskog poliangitisa iznosi 375 mg/m2 tjelesne površine primijenjeno intravenskom infuzijom jedanput tjedno tijekom 4 tjedna (ukupno četiri infuzije).
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.
(p = 0,029, 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.
A total of 6/34 (18%) of rituximab treated patients from the maintenance therapy clinical trial developed ADA.
U ukupno 6/34 (18 %) bolesnika liječenih rituksimabom u sklopu kliničkog ispitivanja terapije održavanja razvila su se antitijela na lijek.
Chronic lymphocytic leukaemia (CLL)
Kronična limfocitna leukemija (KLL)
Significant benefit from maintenance treatment with rituximab was also seen for the secondary endpoints event-free survival (EFS), time to next anti-lymphoma treatment (TNLT) time to next chemotherapy (TNCT) and overall response rate (ORR) in the primary analysis (Table 7).
U primarnoj analizi uočena je i značajna korist od terapije održavanja rituksimabom u pogledu sekundarnih mjera ishoda: preživljenja bez pojave događaja (EFS), vremena do sljedećeg liječenja limfoma (engl. time to next anti-lymphoma treatment, TNLT), vremena do sljedeće kemoterapije (engl. time to next chemotherapy, TNCT) te stope ukupnog odgovora (ORR) (Tablica 7).
• Inflammation, irritation and / or tightness of the lungs, and throat, coughing
• upala, iritacija i/ili stezanje u plućima i grlu, kašalj
Physicians should exercise caution when considering the use of rituximab in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection, e.g. hypogammaglobulinaemia (see section 4.8).
Liječnici trebaju biti oprezni ako razmatraju primjenu rituksimaba u bolesnika s anamnezom rekurentnih ili kroničnih infekcija ili postojećim bolestima koje ih mogu dodatno predisponirati za ozbiljne infekcije, primjerice hipogamaglobulinemijom (vidjeti dio 4.8).
• respiratory failure
• zatajenje disanja
1 vial of 50 mL 2 vials of 50 mL
1 bočica od 50 ml 2 bočice od 50 ml
The 50 mL vial contains 500 mg of rituximab (10 mg/mL).
Bočica od 50 ml sadrži 500 mg rituksimaba (10 mg/ml).
• swelling of the hands or ankles
• oticanje šaka ili gležnjeva
Rixathon is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Rixathon je dostupan u sterilnim, jednokratnim apirogenim bočicama, bez konzervansa.
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).
• Feeling generally unwell or listless.
• opće loše osjećanje ili bezvoljnost
• muscle problems - such as tight muscles, joint or muscle pain, back and neck pain
• mišićne tegobe - kao što je napetost u mišićima, bol u zglobovima ili mišićima, bol u vratu i leđima
Rixathon is used for the treatment of granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Rixathon se u kombinaciji s kortikosteroidima primjenjuje za liječenje granulomatoze s poliangitisom (ranije se zvala Wegenerova granulomatoza) i mikroskopskog poliangitisa.
Upon administration of rituximab at a dose of 375 mg/m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/mL (range, 16 - 582 µg/mL) after the first infusion to 550 µg/mL (range, 171-1,177 µg/mL) after the eighth infusion.
Nakon primjene rituksimaba u dozi od 375 mg/m2 u obliku intravenske infuzije, osam puta u u razmacima od tjedan dana u 37 bolesnika s NHL-om, srednja vrijednost Cmax povećavala se sa svakom sljedećom infuzijom, a vrijednosti su se kretale od prosječnih 243 µg/ml (raspon 16-582 µg/ml) nakon prve infuzije do 550 µg/ml (raspon 171-1177 µg/ml) nakon osme infuzije.
See section 5.1 for further information.
(vidjeti dio 5.1).
Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab arms compared to control arms.
Tijekom kliničkih ispitivanja prijavljene su infekcije donjih dišnih puteva (uključujući upalu pluća), a incidencija im je bila slična u skupinama koje su primale rituksimab i u kontrolnim skupinama.
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 najviše mjesec dana od primjene posljednje pulsne doze ciklofosfamida, bolesnici su bili randomizirani za primanje rituksimaba (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]).
• Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth
• probavne smetnje, proljev, refluks kiseline, iritacija i/ili pojava vrijedova u grlu i ustima
42-months p=0.029
42 mjeseca p = 0,029
A total of 23/99 (23%) rituximab-treated patients from the induction of remission trial tested positive for ADA by 18 months.
Ukupno je 23/99 (23 %) bolesnika liječenih rituksimabom u ispitivanju poticanja remisije do 18. mjeseca bilo pozitivno na antitijela na lijek.
Progression-free survival (PFS) Overall survival
Progression Free Survival)
The efficacy and safety of rituximab 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.
Kliničko iskustvo u liječenju običnog pemfigusa Djelotvornost i sigurnost rituksimaba u kombinaciji s kratkoročnom terapijom niskom dozom glukokortikoida (prednizona) ocjenjivale su se u novodijagnosticiranih bolesnika s umjerenim do teškim pemfigusom (74 bolesnika s običnim pemfigusom [PV] i 16 bolesnika koji su imali pemphigus foliaceus [PF]) u randomiziranom, otvorenom, kontroliranom, multicentričnom ispitivanju.
In patients with rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Rixathon infusions to decrease the incidence and severity of infusion related reactions (IRRs).
U bolesnika s reumatoidnim artritisom, granulomatozom s poliangitisom (Wegenerovom granulomatozom) ili mikroskopskim poliangitisom u remisiji ili s običnim pemfigusom treba primijeniti premedikaciju metilprednizolonom u dozi od 100 mg intravenski radi smanjenja incidencije i težine reakcija povezanih s infuzijom, a primjena mora završiti 30 minuta prije početka infuzije lijeka Rixathon.
Patients in the rituximab group who relapsed could receive an additional infusion of rituximab 1000 mg in combination with reintroduced or escalated prednisone dose.
Bolesnicima u skupini liječenoj rituksimabom koji su doživjeli relaps mogla se primijeniti dodatna infuzija rituksimaba u dozi od 1000 mg te ponovno uvesti prednizon ili povećati njegova doza.
It is recommended that immunoglobulin levels are determined prior to initiating treatment with Rixathon.
Preporučuje se prije početka liječenja lijekom Rixathon odrediti razine imunoglobulina.
The 10 mL vial contains 100 mg of rituximab (10 mg/mL).
Bočica od 10 ml sadrži 100 mg rituksimaba (10 mg/ml).
A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
Ukupno je 197 bolesnika u dobi od 15 ili više godina s teškom aktivnom granulomatozom s poliangitisom (75 %) i mikroskopskim poliangitisom (24 %) sudjelovalo i liječeno u randomiziranom,
• If you are having Rixathon alone
• ako se liječite samo lijekom Rixathon
In the PV population, 5 (13%) patients in the rituximab group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the rituximab group and 33 (92%) patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
U populaciji bolesnika s PV-om 5 (13 %) bolesnika liječenih rituksimabom i 3 (8 %) bolesnika liječena standardnom dozom prednizona imala su umjereni oblik bolesti, dok su 33 (87 %) bolesnika liječena rituksimabom i
10 mL vial: Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL.
Bočica od 10 ml: staklene bočice (bezbojno staklo tipa I) s butil gumenim čepom koje sadrže 100 mg rituksimaba u 10 ml.
Most adverse events in the rituximab arm were mild or moderate in intensity.
Većina štetnih događaja u skupini bolesnika liječenih rituksimabom bila je blagog ili umjerenog intenziteta.
Rixathon 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.
Monoterapija lijekom Rixathon indicirana je u liječenju bolesnika oboljelih od folikularnog limfoma stadija III-IV koji su rezistentni na kemoterapiju ili su u drugom odnosno sljedećem relapsu nakon kemoterapije.
The majority of patients had received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Većina je bolesnika primala rituksimab u kombinaciji s kemoterapijom ili u sklopu presađivanja hematopoetskih matičnih stanica.
The recommended dosage of Rixathon is 1,000 mg by intravenous infusion followed by a second 1,000 mg intravenous infusion two weeks later.
Rixathon je 1000 mg primijenjeno intravenskom infuzijom, a potom drugih 1000 mg intravenskom infuzijom nakon dva tjedna.
Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the Rixathon infusion.
S obzirom da tijekom primjene rituksimaba može doći do hipotenzije, potrebno je razmotriti mogućnost izostavljanja antihipertenzivnog lijeka 12 sati prije davanja infuzije lijeka Rixathon.
Packs of 1 or 2 vials.
Pakiranje od 1 ili 2 bočice.
• Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica,
• abnormalni osjeti na koži, kao što su utrnulost, trnci, bockanje ili žarenje, išijas, migrena,
Toxic Epidermal Necrolysis (Lyell syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Vrlo su rijetko prijavljeni toksična epidermalna nekroliza (Lyellov sindrom) i Stevens-Johnsonov sindrom, ponekad sa smrtnim ishodom.
• Pain on passing water (urinary tract infection)
• bol pri mokrenju (infekcija mokraćnih putova)
• A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems
• osjećaj začepljenosti ili pulsirajuća bol iza nosa, obraza i očiju (sinusitis), bol u trbuhu,
Aseptic handling must be ensured when preparing the infusion.
Kod pripreme infuzije mora se osigurati aseptičko rukovanje.
Initial treatment, weekly for 4 doses
Početno liječenje, prošireni tumor, jedanput tjedno tijekom 4 tjedna
• long lasting depression
• dugotrajna depresija
PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Rixathon Alert Card for patients with non-oncology diseases
Rixathon kartica s upozorenjima za bolesnike s neonkološkim bolestima
- The need to provide patients with the Patient Alert Card with each infusion
- Bolesnici moraju kod svake infuzije dobiti Karticu s upozorenjima za bolesnika.
• heart beating faster than normal
• bol u mišićima • brže kucanje srca nego obično
Repeated courses of treatment with Rixathon are possible.
Ciklusi liječenja lijekom Rixathon mogu se ponavljati.
The most common infections in the rituximab arm included upper respiratory tract infections, gastroenteritis, urinary tract infections and herpes zoster.
Najčešće infekcije u skupini liječenoj rituksimabom uključivale su infekcije gornjih dišnih putova, gastroenteritis, infekcije mokraćnih putova i herpes zoster.
Median EFS: 36 Not reached p < 0.0001
Medijan EFS: Nije dostignuto p < 0,0001
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane hiperkolesterolemija
In the clinical trial on induction of remission, which included 99 rituximab-treated patients, the overall rate of infection was approximately 237 per 100 patient years (95% CI 197 - 285) at the 6-month primary endpoint.
ukupna stopa infekcija iznosila je približno 237 na 100 bolesnik-godina (95 % CI 197 - 285) u trenutku primarne mjere ishoda nakon 6 mjeseci.
Depression, anxiety
Psihijatrijski poremećaji depresija, tjeskoba
The most common symptoms were allergic reactions like headache, pruritus, throat irritation, flushing, rash, urticaria, hypertension, and pyrexia.
Najčešći simptomi bile su alergijske reakcije, kao što su glavobolja, svrbež, iritacija grla, crvenilo praćeno osjećajem vrućine, osip, urtikarija, hipertenzija i vrućica.
In case of such an event with a suspected relationship to Rixathon, treatment should be permanently discontinued.
uz sumnju na povezanost s lijekom Rixathon, liječenje se mora trajno prekinuti.
Serum ickness-like reaction
reakcija nalik serumskoj bolesti
Patient subpopulations - rituximab combination therapy
Podskupine bolesnika - liječenje rituksimabom u kombinaciji
A course of Rixathon consists of two 1,000 mg intravenous infusions.
Ciklus liječenja lijekom Rixathon čine dvije intravenske infuzije od 1000 mg.
50 mL vial: Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 mL.
Bočica od 50 ml: staklene bočice (bezbojno staklo tipa I) s butil gumenim čepom koje sadrže 500 mg rituksimaba u 50 ml.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U
1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials
1 Kategorija učestalosti dodijeljena na temelju laboratorijskih vrijednosti prikupljenih tijekom rutinskih laboratorijskihkontrola u kliničkim ispitivanjima 2 Kategorija učestalosti dodijeljena na temelju podataka nakon stavljanja lijeka u promet.
Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 months following treatment with Rixathon.
Kontracepcija u muškaraca i žena Zbog dugog vremena zadržavanja rituksimaba u bolesnika s deplecijom B-stanica, žene reproduktivne dobi moraju koristiti učinkovite metode kontracepcije tijekom i 12 mjeseci nakon terapije lijekom
The ORR was 36% (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
21 % - 51 %; CR 3 %, PR 33 %), a medijan TTP-a u bolesnika koji su odgovorili na liječenje 9,6 mjeseci (raspon od 4,5 do 26,8 mjeseci).
• recurrence of a previous Hepatitis B infection d) If you are being treated for pemphigus vulgaris
• povratak ranije hepatitis B infekcije d) Bolesnici koji se liječe od običnog pemfigusa
The most common infections in the rituximab group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Najčešće infekcije u skupini koja je primala rituksimab bile su herpes simplex i herpes zoster, bronhitis, infekcije mokraćnih putova, gljivične infekcije te konjunktivitis.
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,
U otvorenom randomiziranom ispitivanju ukupno su 322 prethodno neliječena bolesnika s folikularnim limfomom slučajnim odabirom određena za primanje CVP kemoterapije (ciklofosfamid
Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease (see section 4.4 regarding other cardiovascular diseases).
Teško zatajenje srca (New York Heart Association stupanj IV) ili teška nekontrolirana srčana bolest
Hepatitis-B reactivation
Reaktivacija hepatitisa B
Dyspepsia, diarrhoea, gastrooesophageal reflux, mouth ulceration, upper abdominal pain
Poremećaji probavnog sustava dispepsija, proljev, gastroezofagealni refluks, vrijed usta, bol u gornjem abdomenu