natgillin/translations-raw huggingface dataset:
The incidence of infection was 38% in the Gazyvaro plus chlorambucil arm and 37% in the rituximab plus chlorambucil arm (with Grade 3-5 events reported in 12% and 14%, respectively and fatal events reported in < 1% in both treatment arms). 
Gazyvaro in klorambucila 38-% in s kombinacijo rituksimaba in klorambucila 37-% (neželene učinke od 3. do 5. stopnje so zabeležili pri 12 % bolnikov v prvi skupini in 14 % v drugi skupini, učinkov s smrtnim izidom pa je bilo v obeh skupinah < 1 %).
· Follicular lymphoma (also called “FL”) Gazyvaro is used in patients who have not had any treatment for FL Gazyvaro is used in patients who have had at least one treatment with a medicine called rituximab before and whose FL has come back or got worse during or after this treatment. 
Zdravilo Gazyvaro uporabljamo pri bolnikih, ki so pred tem prejemali vsaj eno zdravljenje z zdravilom, imenovanim rituksimab, a se je folikularni limfom med tem zdravljenjem ali po njem pri njih ponovil ali poslabšal.
Upper respiratory tract infection, sinusitis§, , urinary tract infection, pneumonia§ ,herpes zoster§ 
Infekcijske in parazitske bolezni zelo pogosti okužba zgornjih dihal, sinuzitis§, okužba sečil, pljučnica§, herpes zoster§
IRRs are very common during the first infusion of Gazyvaro, and patients experiencing infusion related symptoms should be advised not to drive or use machines until symptoms abate. 
Bolnikom, pri katerih se pojavijo z infuzijo povezani simptomi, je treba naročiti, naj ne upravljajo vozil ali strojev, dokler simptomi ne minejo.
Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative such as a urate oxidase (e.g. rasburicase) starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice. 
To naj sestaljata ustrezna hidracija in dajanje urikostatika (npr. alopurinola) ali primernega alternativnega zdravljenja, kot je uratna oksidaza (npr. rasburikaza), ki se začne 12 do
Kaplan-Meier curves for progression-free survival (PFS) are shown in Figure 5. 
Meierjevi krivulji preživetja brez napredovanja bolezni sta prikazani na sliki 5.
Cases of arrhythmias (such as atrial fibrillation and tachyarrhythmia), angina pectoris, acute coronary syndrome, myocardial infarction and heart failure have occurred when treated with Gazyvaro (see section 4.4). 
Med zdravljenjem z zdravilom Gazyvaro so se pojavili primeri motenj srčnega ritma (npr. atrijska fibrilacija in tahiaritmije), angine pektoris, akutnega koronarnega sindroma, akutnega miokardnega infarkta in srčnega popuščanja (glejte poglavje 4.4).
They will help you weigh up the benefit of continuing Gazyvaro against the risk to your baby. 
Gazyvaro v primerjavi s tveganjem za otroka.
Cough, oropharyngeal pain 
• herpetični mehurčki
Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first). 
Bolniki, ki dosežejo popolni ali delni odgovor na indukcijsko zdravljenje z zdravilom Gazyvaro v kombinaciji s kemoterapijo, morajo še naprej prejemati monoterapijo z zdravilom Gazyvaro 1000 mg kot vzdrževalno zdravljenje enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
1See section 5.1 for information on chlorambucil dose 
1 Za podatke o odmerku klorambucila glejte poglavje 5.1.
Median observation time 35 months 
Mediani čas opazovanja
Four percent of patients treated with Gazyvaro plus chlorambucil experienced acute thrombocytopenia (occurring within 24 hours after the Gazyvaro infusion) (see section 4.4). 
Akutna trombocitopenija (nastala v 24 urah po infundiranju zdravila Gazyvaro) se je pojavila pri 4 % bolnikov, zdravljenih s kombinacijo zdravila Gazyvaro in klorambucila (glejte poglavje 4.4).
No renal toxicity with a causal relationship to obinutuzumab has been observed in humans. 
Pri človeku niso opazili toksičnosti za ledvice, ki bi bila vzročno povezana z obinutuzumabom.
White blood cell count decreased, neutrophil count decreased, weight increased 
Preiskave pogosti zmanjšanje števila belih krvnih celic, zmanjšanje števila nevtrofilcev, povečanje telesne mase zmanjšanje števila belih krvnih celic, zmanjšanje števila nevtrofilcev
The bag should be gently inverted to mix the solution in order to avoid excessive foaming. 
Da bi preprečili pretirano penjenje raztopine, je treba vrečko za premešanje raztopine previdno obračati.
· The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, poloxamer 188 and water for injections. 
• Druge sestavine zdravila so histidin, histidinijev klorid monohidrat, trehaloza dihidrat,
Fatal haemorrhagic events have also been reported in Cycle 1 in patients treated with Gazyvaro. 
Pri bolnikih, zdravljenih z zdravilom Gazyvaro, so bili v 1. ciklu opisane tudi krvavitve s smrtnim izidom.
For each subsequent treatment cycle (Cycles 2 to 6), patients received Gazyvaro 1,000 mg on Day 1 only. 
V vseh nadaljnjih ciklih zdravljenja (2. do 6. cikel) so bolniki dobili 1000 mg zdravila Gazyvaro samo 1. dan. Klorambucil so dobivali peroralno v odmerku 0,5 mg/kg telesne mase 1. in 15. dan v vseh ciklih zdravljenja (od 1. do 6.
· infection of upper airways (infection of nose, pharynx, larynx and sinuses), cough 
• okužba zgornjih dihalnih poti (okužba nosu, žrela, grla in sinusov), kašelj Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)
No. (%) of patients with event Median time to event (months) 
Število (%) bolnikov z dogodkom 65 (55,1 %) Mediani čas do dogodka (meseci)
Administer at 50 mg/hr. 
začnite s hitrostjo 50 mg/uro.
Patients with renal impairment (CrCl < 50 mL/min) are more at risk of thrombocytopenia (see section 4.8). 
Bolniki z ledvično okvaro (očistek kreatinina < 50 ml/min) imajo večje tveganje za trombocitopenijo (glejte poglavje 4.8).
Hypotension, as a symptom of IRRs, may occur during Gazyvaro intravenous infusions. 
Med intravenskim infundiranjem zdravila Gazyvaro se lahko kot simptom reakcij, povezanih z infuzijo, pojavi hipotenzija.
In the pivotal BO21004/CLL11 study, 27% (90 out of 336) of patients treated with Gazyvaro plus chlorambucil had moderate renal impairment (CrCl < 50 mL/min). 
V ključni študiji BO21004/CLL11 je imelo zmerno ledvično okvaro (očistek kreatinina < 50 ml/min) 27 % (90 od 336) bolnikov, zdravljenih s kombinacijo zdravila Gazyvaro in klorambucila.
Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy (CHOP or CVP or bendamustine) should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first). 
Bolniki, ki dosežejo popolni ali delni odgovor na indukcijsko zdravljenje z zdravilom Gazyvaro v kombinaciji s kemoterapijo (CHOP, CVP ali bendamustin) nadaljujejo z monoterapijo z zdravilom Gazyvaro 1000 mg kot vzdrževalnim zdravljenjem enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
Median observation time: 20 months 
Mediani čas opazovanja:
How to store Gazyvaro 
Kako uporabljati zdravilo Gazyvaro Prejemanje zdravila Gazyvaro
Cycles 2-6 or 2-8 - this will be just one dose of Gazyvaro in the 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro: · Day 1 - full dose (1,000 mg). 
2. do 6. ali 2. do 8. cikel - vključujejo le en odmerek zdravila Gazyvaro v 28 ali 21 dneh, odvisno od tega, katera druga zdravila za zdravljenje raka boste prejeli skupaj z zdravilom Gazyvaro:
To prepare the 2 infusion bags, withdraw 40 mL of concentrate from the vial and dilute 4 mL into a 100 mL PVC or non-PVC polyolefin infusion bag and the remaining 36 mL in a 250 mL PVC or non-PVC polyolefin infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection. 
Za zagotovitev razlikovanja obeh infuzijskih vrečk za začetni odmerek 1.000 mg je priporočljivo uporabiti različno veliki vrečki, da lahko razlikujete med 100-mg odmerkom za 1. dan 1. cikla in 900mg odmerkom za 1. dan 1. cikla (nadaljevanje) ali 2. dan. Za pripravo 2 infuzijskih vrečk potegnite iz viale 40 ml koncentrata in 4 ml razredčite v 100-ml PVC ali ne-PVC poliolefinski infuzijski vrečki, preostalih 36 ml pa v 250-ml PVC ali ne-PVC poliolefinski infuzijski vrečki, ki vsebujeta 0,9-% (9 mg/ml) raztopino natrijevega klorida za injekcije.
How Gazyvaro works 
Kako deluje zdravilo Gazyvaro
Squamous cell carcinoma of skin Squamous cell carcinoma of skin Blood and lymphatic system disorders Very common 
pogosti ploš čatocelični karcinom kože ploš čatocelični karcinom kože
Induction treatment of approximately six months (six treatment cycles of Gazyvaro, each of 28 day duration when combined with bendamustine, or eight treatment cycles of Gazyvaro, each of 21 day duration when combined with CHOP or CVP) followed by maintenance once every 2 months for 2 years or until disease progression (whichever occurs first). 
Gazyvaro v kombinaciji z bendamustinom ali osem 21-dnevnih ciklov zdravljenja z zdravilom Gazyvaro v kombinaciji s CHOP ali CVP), ki mu sledi vzdrževalno zdravljenje enkrat na 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej).
Thrombocytopenia and haemorrhagic events 
Trombocitopenija in hemoragični dogodki
· You will be given 6 or 8 treatment cycles of Gazyvaro in combination with other medicines for cancer - each cycle lasts 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro. 
• Dobili boste 6 ali 8 ciklov zdravljenja z zdravilom Gazyvaro v kombinaciji z drugimi zdravili za zdravljenje raka.
Your doctor may decide to stop treatment with Gazyvaro if you have a severe infusion related reaction. 
Če se vam pojavi huda reakcija, povezana z infuzijo, se zdravnik lahko odloči, da ukine zdravljenje z zdravilom Gazyvaro.
Urinary tract infection, pneumonia, lung infection, upper respiratory tract infection, sinusitis, herpes zoster 
nazofaringitis okužba sečil, pljučnica, okužba pljuč, okužba zgornjih dihal,
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen GERMANY 
D-79639 Grenzach-Wyhlen Nemčija
2See section 5.1 for information on bendamustine dose 
2 Za podatke o odmerku bendamustina glejte poglavje 5.1.
Figure 7 Kaplan-Meier curve of OS in patients with FL # (Study GAO4753g/GADOLIN) 
Kaplan-Meierjeva krivulja celokupnega preživetja pri bolnikih s folikularnim limfomom# (študija GAO4753g/GADOLIN)
Nasopharyngitis, rhinitis, influenza, oral herpes 
sinuzitis, herpes zoster občasni nazofaringitis, rinitis, gripa, herpes uste votline
If no IRR occurred during the previous infusion, when the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. 
Če med predhodnim infundiranjem ni bilo reakcij, povezanih z infuzijo, ko je bila končna hitrost infundiranja 100 mg/uro ali več, je mogoče infundiranje začeti s hitrostjo 100 mg/uro in hitrost povečevati po 100 mg/uro vsakih 30 minut do največ 400 mg/uro.
GAO4753g/GADOLIN) that occurred at a higher incidence (difference of ≥ 2%) compared to the relevant comparator arm in at least one pivotal study in: · Patients with CLL receiving Gazyvaro plus chlorambucil compared with chlorambucil alone or rituximab plus chlorambucil (study BO21004/CLL11) · Patients with previously untreated iNHL receiving Gazyvaro plus chemotherapy (bendamustine, CHOP, CVP) followed by Gazyvaro maintenance in patients achieving a response, compared to rituximab plus chemotherapy followed by rituximab maintenance in patients achieving a response (study BO21223/GALLIUM) · Patients with iNHL who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen receiving Gazyvaro plus bendamustine, followed by Gazyvaro maintenance in some patients, compared to bendamustine alone (study GAO4753g/GADOLIN) The incidences presented in Table 6 (all grades and Grades 3-5) are the highest incidence of that ADR reported from any of the three studies. 
Poročana je samo največja pogostnost, opažena v preskušanjih (v študijah BO21004: predhodno nezdravljena KLL, BO21223: predhodno nezdravljen napredovali iNHL in GAO4753g: rituksimab pri refraktarnem iNHL) † Incidenca nobenega neželenega učinka 5. stopnje se med skupinama v študiji ni razlikovala za ≥ 2 % * Kemoterapija: klorambucil pri KLL; bendamustin, CHOP, CVP pri iNHL, vključno s FL § Opažen tudi med vzdrževalnim zdravljenjem z vsaj 2 % večjo incidenco v skupini, zdravljeni z zdravilom Gazyvaro (BO21223)
However, in patients with FL the addition of Gazyvaro to bendamustine delayed the time to worsening of health-related quality of life as measured by the FACT-Lym TOI score by 2.2 months (median 5.6 versus 7.8 months for B and G+B respectively HR = 0.83; 95% CI: 0.60, 1.13). 
2,2 meseca (mediana 5,6 meseca z bendamustinom in 7,8 meseca z G + B; HR = 0,83, 95-% IZ: 0,60;
If you miss your appointment, make another one as soon as possible. 
Če izpustite dajanje zdravila Gazyvaro, se čim prej dogovorite za drug termin.
For management of symptomatic adverse events (including IRRs), see paragraph below (Management of IRRs or section 4.4). 
prosimo, glejte spodnji odstavek (Obvladovanje reakcij, povezanih z infuzijo, ali poglavje 4.4).
Neutropenia, thrombocytopenia 
• depresija, tesnoba
System organ class Frequency 
• povečanje telesne mase
Table 4 Chronic lymphocytic leukaemia: Standard infusion rate in the absence of IRRs/hypersensitivity and recommendations in case an IRR occurred with previous infusion 
Kronična limfocitna levkemija: standardna hitrost infundiranja v primeru, da ni reakcij, povezanih z infuzijo/preobčutljivostjo, in priporočila, če se je reakcija, povezana z infuzijo, pojavila med predhodno infuzijo
The rate of infusion can be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. 
Hitrost infundiranja je mogoče povečevati po 50 mg/uro vsakih 30 minut do največ 400 mg/uro.
Clear, colourless to slightly brownish liquid. 
Bistra, brezbarvna do rjavkasta tekočina.
Figure 8 IRC-assessed PFS by patient subgroup in FL *# (Study GAO4753g/GADOLIN) 
Preživetje brez napredovanja bolezni (po oceni IRC) po podskupinah bolnikov s folikularnim limfomom*# (študija GAO4753g/GADOLIN)
Cases of hepatitis B reactivation have been reported in patients treated with Gazyvaro (see section 4.4). 
Pri bolnikih, zdravljenih z zdravilom Gazyvaro, so poročali o PML (glejte poglavje 4.4).
Figure 6 Kaplan-Meier curve of IRC-assessed PFS in patients with FL # (Study GAO4753g/GADOLIN) 
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (po oceni IRC) pri bolnikih s folikularnim limfomom# (študija GAO4753g/GADOLIN)
Patients with a high tumour burden and/or a high circulating lymphocyte count (> 25 x 109/L) and/or renal impairment (CrCl < 70 mL/min) are considered at risk of TLS and should receive prophylaxis. 
(> 25 x 109/l) in/ali ledvično okvaro (očistek kreatinina < 70 ml/min) imajo večje tveganje za sindrom razpada tumorja in morajo prejeti profilakso.
Dose delays should be considered in case of severe or life-threatening neutropenia. 
Pri hudi ali življenje ogrožajoči nevtropeniji je treba razmisliti o preložitvi odmerka na kasnejši čas.
NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab 
Gazyvaro 1000 mg koncentrat za raztopino za infundiranje obinutuzumab
Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen 
Bolniki s folikularnim limfomom, ki se na zdravljenje z rituksimabom ali shemo, ki je vključevala rituksimab, niso odzvali ali jim je bolezen med ali v 6 mesecih po takšnem zdravljenju napredovala
The rate of infusion can be escalated in increments up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr. 
Hitrost infundiranja je mogoče povečevati v korakih po 50 mg/uro vsakih 30 minut do največje hitrosti 400 mg/uro.
You may be more likely to get an infection during and after treatment with Gazyvaro. 
Med zdravljenjem z zdravilom Gazyvaro ali po njem se vam bo morda povečala dovzetnost za okužbo.
· muscle and bone pain in your chest · skin cancer (squamous cell carcinoma) · bone pain, pain in arms and legs · irregular heart beat (atrial fibrillation), heart failure · problems with urinating, urinary incontinence · high blood pressure · problems with digestion (e.g. heartburn), inflammation of the intestine, haemorrhoids · changes shown in blood tests: 
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti artralgija§, bolečina v hrbtu pogosti mišično-skeletna bolečina v prs nem koš u, bolečina v okončinah, bolečina v kosteh bolečina v okončinah občasni artralgija, bolečina v hrbtu, mišično-skeletna bolečina v prsnem košu, bolečina v kosteh
If no IRR or if an IRR Grade 1 occurred during the previous infusion when the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. 
Če med predhodnim infundiranjem ni bilo reakcij, povezanih z infuzijo, ali če so bile le-te 1. stopnje ob končni hitrosti infundiranja 100 mg/uro ali več, je mogoče infundiranje znova začeti s hitrostjo 100 mg/uro in jo povečevati po 100 mg/uro vsakih 30 minut do največ 400 mg/uro.
Hazard ratio (95% CI) p-value (Log-Rank test, stratified b) 
Vrednost p (stratificirani log-rang test b)
Intravenous corticosteroid1,4 (mandatory for CLL, recommended for FL) 
(obvezno pri KLL, priporočljivo pri FL)
Figure 1 Kaplan-Meier curve of Investigator assessed PFS from Stage 1a in patients with CLL (Study BO21004/CLL11) 
Slika 1.Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po raziskovalčevi oceni za fazo 1a pri bolnikih s KLL (študija BO21004/CLL11)
Patients must not receive further Gazyvaro infusions if they experience: · acute life-threatening respiratory symptoms, · a Grade 4 (i.e. life threatening) IRR or, · a second occurrence of a Grade 3 (prolonged/recurrent) IRR (after resuming the first infusion or during a subsequent infusion). 
• ponovna z infuzijo povezana reakcija 3. stopnje (podaljšana/ponovna) po ponovnem začetku prve infuzije ali med katero od nadaljnjih infuzij).
Figure 2 Kaplan-Meier curve of OS from Stage 1a in patients with CLL (Study BO21004/CLL11) 
Kaplan-Meierjeva krivulja celokupnega preživetja za fazo 1a pri bolnikih s KLL (študija BO21004/CLL11)
Dose of Gazyvaro to be administered 
Odmerek zdravila Gazyvaro, ki ga je treba uporabiti
Thirty-four percent of patients were enrolled on comorbidity score alone, and 23% of patients were enrolled with only impaired renal function. 
42 % vključenih bolnikov je imelo hkrati očistek kreatinina < 70 ml/min in oceno komorbidnosti > 6. 34 % bolnikov je bilo vključenih le zaradi ocene komorbidnosti in 23 % le zaradi okvare delovanja ledvic.
Instructions for dilution 
koncentrat za raztopino za infundiranje
# Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen 
# Bolniki s FL, ki se na zdravljenje z rituksimabom ali shemo, ki je vključevala rituksimab, niso odzvali ali jim je bolezen med ali v 6 mesecih po takšnem zdravljenju napredovala.
Nervous system disorders Very common 
Bolezni živčevja zelo pogosti glavobol pogosti glavobol
Figure 4 Kaplan-Meier curve of OS from Stage 2 in patients with CLL (Study BO21004/CLL11) 
Kaplan-Meierjeva krivulja celokupnega preživetja za 2. fazo pri bolnikih s KLL (študija BO21004/CLL11)
Prophylaxis and premedication for infusion related reactions (IRRs) 
Profilaksa reakcij, povezanih z infuzijo, in premedikacija zanje Premedikacija za zmanjšanje tveganja za reakcije, povezane z infuzijo, je prikazana v preglednici 1
Table 5 Follicular lymphoma: Standard infusion rate in the absence of IRRs /hypersensitivity and recommendations in case an IRR occurred with previous infusion 
Folikularni limfom: standardna hitrost infundiranja v primeru, da ni reakcij, povezanih z infuzijo/preobčutljivosti, in priporočila, če se je reakcija, povezana z infuzijo, pojavila med predhodno infuzijo
You must not be given Gazyvaro if: 
Bolniki ne smejo dobiti nadaljnjih infuzij zdravila Gazyvaro, če se pri njih pojavi oziroma pojavijo:
Best Overall Response (BOR) (IRC-assessed) No. of patients included in the analysis Responders (%) (CR/PR) Difference in response rate (95% CI) p-value (Cochran-Mantel-Haenszel test) Complete Responders (%) Partial Responders (%) Stable Disease (%) Duration of response (DOR) (IRCassessed) No of patients included in the analysis No. (%) of patients with event Median duration (months) of DOR (95% CI) 
Delež odgovora ob koncu zdravljenja Število bolnikov, vključenih v analizo Odzivni bolniki (%) Neodzivni bolniki (%) Razlika v deležu odgovora (95-% IZ) Vrednost p (test hi-kvadrat)
Package leaflet: Information for the patient Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab 
Navodilo za uporabo Gazyvaro 1000 mg koncentrat za raztopino za infundiranje obinutuzumab
Figure 3 Kaplan-Meier curve of investigator assessed PFS from Stage 2 in patients with CLL (Study BO21004/CLL11) 
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po raziskovalčevi oceni za 2. fazo pri bolnikih s KLL (študija BO21004/CLL11)
Women of childbearing potential 
• nočno potenje
Eye disorders Common 
• rdeče oči
Contents of the pack and other information What Gazyvaro contains · The active substance is obinutuzumab: 1,000 mg/40 mL per vial corresponding to a concentration before dilution of 25 mg/mL. 
• Učinkovina je obinutuzumab: 1000 mg/40 ml na vialo; to ustreza koncentraciji 25 mg/ml pred razredčenjem.
Bendamustine was given intravenously on Days 1 and 2 for all treatment cycles (Cycles 1-6) at 90 mg/m2/day when given in combination with Gazyvaro. 
Če so v kombinaciji z zdravilom Gazyvaro uporabili bendamustin, so ga aplicirali intravensko v odmerku 90 mg/m2/dan 1. in 2. dan vsakega cikla zdravljenja (cikli 1-6).
IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, NR = Not Reached # Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen *Stratification factors for analysis were refractory type (rituximab monotherapy vs. rituximab + chemotherapy) and prior therapies (≤ 2 vs > 2). 
IRC: odbor za neodvisni pregled, PFS: preživetje brez napredovanja bolezni, IZ: interval zaupanja, MRD (Minimal Residual Disease): minimalna rezidualna bolezen, ND = ni dosežen.
Median observation time 34 months 
34 mesecev
2 Bendamustine is given intravenously on Days 1 and 2 of all treatment cycles (Cycles 1-6) at 90 mg/m2/day; CHOP and CVP according to standard regimens 
90 mg/m2/dan; CHOP in CVP dajemo glede na standardna režima odmerjanja.
In the Gazyvaro plus chemotherapy arm, the incidence of Grade 1-4 neutropenia (50%) was higher relative to the comparator arm with an increased risk during the induction period. 
Pri kombinaciji zdravila Gazyvaro in bendamustina je bila incidenca nevtropenije 1. do 4. stopnje
The demographic data and baseline characteristics of the patient population were well balanced between the treatment arms; median age was 59 years, 81% were Caucasian, 53% were female, 79% had a FLIPI score of ≥ 2 and 7% had Stage II (bulky), 35% had Stage III and 57% had Stage IV disease, 44% had bulky disease (> 7 cm), 34% had at least one B-symptom at baseline and 97% had an ECOG performance status of 0-1 at baseline. 
Demografski podatki in izhodiščne značilnosti populacije bolnikov so bili med zdravljenima skupinama dobro uravnoteženi; mediana starost je bila 59 let, 81 % bolnikov je bilo belcev, 53 %