natgillin/translations-raw huggingface dataset:
If there are any modifications of the infusion rate or interruptions during the first 100 mg the second bag must be administered the following day. 
Če je med dajanjem prvih 100 mg treba spremeniti hitrost infundiranja ali infundiranje prekiniti, je treba drugo vrečko dati naslednji dan.
The PFS results in the post hoc analysis are consistent with the primary analysis and its significance is unchanged and the safety profile is consistent with the primary analysis. 
Rezultati preživetja brez napredovanja bolezni v analizi post hoc so skladni s primarno analizo; pomen preživetja brez napredovanja bolezni je nespremenjen in varnostni profil skladen s primarno analizo.
· Tell your doctor or nurse straight away if you get any signs of infection after your Gazyvaro treatment (see "Infections" in section 4). 
• Zdravniku ali medicinski sestri takoj povejte, če se po zdravljenju z zdravilom Gazyvaro pri vas pojavijo kakršni koli znaki okužbe (glejte poglavje 4 “Okužbe”).
· This induction phase will be followed by a “maintenance phase” - during this time you will be given Gazyvaro every 2 months for up to 2 years as long as your disease does not progress. 
• Temu indukcijskemu zdravljenju bo sledilo vzdrževalno zdravljenje - med tem časom boste v naslednjih dveh letih dobili zdravilo Gazyvaro vsaka 2 meseca, dokler vaša bolezen ne bo napredovala.
Some signs/symptoms regarded as “cortical” (e.g. aphasia or visual-spatial disorientation) may occur. 
Pojavijo se lahko nekateri znaki ali simptomi, ki veljajo za "kortikalne" (npr. afazija ali vizualno-prostorska dezorientiranost).
The incidence of prolonged neutropenia and late onset neutropenia was 3% and 7%, respectively. 
Incidenca podaljšane nevtropenije je bila 3 % in zakasnjene nevtropenije 7 %.
Day 2 (or Day 1 continued) 
2. dan (ali 1. dan - nadaljevanje)
There have been no studies performed with other routes of administration. 
Raziskav o drugih načinih uporabe niso izvedli.
With a median observation time of 24.1 months for FL patients, 48 patients (28.1%) in the B arm and 30 patients (18.3%) in the G+B arm had died. 
Mediani čas opazovanja za bolnike s folikularnim limfomom je bil 24,1 meseca; 48 bolnikov (28,1 %) iz skupine, ki je prejemala bendamustin, in 30 bolnikov (18,3 %) iz skupine, ki je prejemala G + B, je umrlo.
Obinutuzumab is a Type II humanised anti-CD20 monoclonal antibody of the IgG1 subclass derived by humanisation of the parental B-Ly1 mouse antibody and produced in the Chinese Hamster Ovary cell line by recombinant DNA technology. 
Obinutuzumab je humanizirano anti-CD20 monoklonsko protitelo tipa II podrazreda IgG1, pridobljeno s humanizacijo parentalnega mišjega protitelesa B-Ly1 in proizvedeno v celični liniji jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
Patients who received G-CSF prophylaxis had a lower rate of Grade 3-5 infections (see section 4.4). 
Bolniki, ki so prejeli profilakso G-CSF, so imeli manjši delež okužb 3. do 5. stopnje (glejte poglavje 4.4).
If a planned dose of Gazyvaro is missed, it should be administered as soon as possible; do not omit it or wait until the next planned dose. 
V primeru izpustitve načrtovanega odmerka zdravila Gazyvaro je treba odmerek uporabiti čim prej; ne izpustite ga in ne čakajte do naslednjega načrtovanega odmerka.
The safety of immunisation with live or attenuated viral vaccines following Gazyvaro therapy has not been studied and vaccination with live virus vaccines is not recommended during treatment and until B-cell recovery. 
Varnost imunizacije z živimi ali oslabljenimi virusnimi cepivi po zdravljenju z zdravilom Gazyvaro ni raziskana in cepljenje z živimi virusnimi cepivi med zdravljenjem in do okrevanja celic B ni priporočljivo.
Compared to Type I antibodies, obinutuzumab, a Type II antibody, is characterised by an enhanced direct cell death induction with a concomitant reduction in CDC at an equivalent dose. 
V primerjavi s protitelesi tipa I je za obinutuzumab, ki je protitelo tipa II, značilna močnejša neposredna indukcija celične smrti s sočasnim zmanjšanjem CDC pri ekvivalentnem odmerku.
In patients receiving Gazyvaro plus chemotherapy, the incidence of IRRs was highest on Day 1 and gradually decreased with subsequent infusions. 
Pri bolnikih, ki so prejemali zdravilo Gazyvaro in kemoterapijo, je bila incidenca reakcij, povezanih z infuzijo, največja 1. dan in se je z nadaljnjimi infundiranji postopoma zmanjševala.
The incidence of IRRs with subsequent infusions was 3% with the second 1,000 mg dose and 1% thereafter. 
Incidenca reakcij, povezanih z infuzijo, je bila med nadaljnjimi infundiranji z drugim 1000-mg odmerkom 3-%, pozneje pa 1-%.
An updated RMP should be submitted: · At the request of the European Medicines Agency; · Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
· Before each infusion of Gazyvaro, you will be given medicines which help to reduce possible infusion related reactions or “tumour lysis syndrome”. 
• Pred vsakim infundiranjem zdravila Gazyvaro boste dobili zdravila, ki pomagajo zmanjšati možne reakcije, povezane z infuzijo, ali “sindrom razpada tumorja”.
· If you do have an infusion related reaction following the small part of your first dose, you will be given the rest of your first dose on Day 2. 
• Če se vam po infundiranju majhne količine prvega odmerka pojavi reakcija, povezana z infuzijo, boste preostanek prvega odmerka dobili 2. dan.
11.6% of the patients had marginal zone lymphoma (MZL) and 7.1% had small lymphocytic lymphoma (SLL). 
(marginal zone lymphoma - MZL) in 7,1 % jih je imelo limfom malih limfocitov (small lymphocytic lymphoma - SLL).
The following side effects have been reported with this medicine: 
S tem zdravilom so bili opisani naslednji neželeni učinki:
Oral analgesic/anti-pyretic2 
Peroralni analgetik/antipiretik2
Table 7 Summary of efficacy from BO21004/CLL11 study Stage 1a 
Povzetek o učinkovitosti iz študije BO21004/CLL11 Faza 1a
· Use an effective method of contraception while being treated with Gazyvaro. 
• Med zdravljenjem z zdravilom Gazyvaro uporabljajte učinkovit način kontracepcije.
· Grade 3 (severe): Infusion must be temporarily stopped and symptoms treated. 
• 3. stopnja (hude): Infundiranje je treba začasno ustaviti in zdraviti simptome.
· changes in blood tests: anaemia (low levels of red blood cells) low levels of all types of white blood cell (combined) low levels of neutrophils (a type of white blood cell) low level of platelets (a type of blood cell that helps your blood to clot) 
anemija (majhno število rdečih krvnih celic) majhno število vseh vrst belih krvnih celic (skupaj) majhno število nevtrofilcev (vrste belih krvnih celic) majhno število trombocitov (vrste krvnih celic, ki pomagajo pri strjevanju krvi)
The subgroups evaluated included IPI, FLIPI, Bulky Disease, B Symptoms at baseline, Ann Arbor Stage and ECOG at baseline. 
Ocenjene podskupine so vključevale IPI, FLIPI, obsežno bolezen, izhodiščne B simptome, stadij Ann Arbor in izhodiščni status zmogljivosti po ECOG.
· Grade 4 (life threatening): Infusion must be stopped and therapy must be permanently discontinued. 
• 4. stopnja (življenje ogrožajoče): Infundiranje je treba ustaviti in zdravljenje trajno končati.
Animal studies have shown secretion of obinutuzumab in breast milk (see section 5.3). 
Študije na živalih so pokazale, da se obinutuzumab izloča v materino mleko (glejte poglavje 5.3).
An enhanced pre and postnatal development (ePPND) toxicity study in pregnant cynomolgus monkeys showed no evidence of teratogenic effects. 
Razširjena študija toksičnosti za pred- in poporodni razvoj (enhanced pre and postnatal developmentePPND) pri brejih opicah cynomolgus ni pokazala teratogenih učinkov.
Duration of treatment Six treatment cycles, each of 28 day duration. 
Trajanje zdravljenja Šest ciklov zdravljenja, od katerih vsak traja 28 dni.
Gazyvaro was administered prior to chemotherapy. 
Zdravilo Gazyvaro so aplicirali pred kemoterapijo.
R-Chemo: Rituximab plus chemotherapy, G-Chemo: Gazyvaro plus chemotherapy, HR: hazard ratio, CI: confidence interval 
r-kemo: rituksimab plus kemoterapija, G-kemo: Gazyvaro plus kemoterapija, RO: razmerje ogroženosti, IZ: interval zaupanja
The most frequently observed adverse drug reactions (ADRs) in patients receiving Gazyvaro were IRRs, which occurred predominantly during infusion of the first 1,000 mg. IRRs may be related to cytokine release syndrome which has also been reported in Gazyvaro treated patients. 
Najpogosteje opaženi neželeni učinki pri bolnikih, ki so prejemali zdravilo Gazyvaro, so bile reakcije, povezane z infuzijo, ki so se pretežno pojavile med infundiranjem prvih 1000 mg. Reakcije, povezane z infuzijo, so lahko povezane s sindromom sproščanja citokinov, o katerem so prav tako poročali pri bolnikih, zdravljenih z zdravilom Gazyvaro.
22.8 months median observation time g 
22,8 meseca g
In study GAO4753g/GADOLIN, patients in the bendamustine arm received 6 months of induction treatment only, whereas after the induction period, patients in the Gazyvaro plus bendamustine arm continued with Gazyvaro maintenance treatment. 
V študiji GAO4753g/GADOLIN so bolniki v skupini z bendamustinom prejeli samo 6-mesečno indukcijsko zdravljenje, medtem ko so po indukcijskem obdobju bolniki v skupini, zdravljeni z zdravilom Gazyvaro in bendamustinom, nadaljevali z zdravljenjem z zdravilom Gazyvaro.
It should be given as an intravenous infusion through a dedicated line after dilution. 
Po razredčenju ga je treba dati kot intravensko infuzijo po namenski liniji.
Gazyvaro can be used in adults to treat two different types of cancer 
Zdravilo Gazyvaro uporabljamo za zdravljenje dveh vrst raka pri odraslih:
Efficacy results for patients with previously untreated FL are summarised in Table 8. 
Rezultati učinkovitosti pri bolnikih s predhodno nezdravljenim FL so povzeti v preglednici 8.
For CLL cycles 2 - 6 and all FL cycles 
Za 2. do 6. cikel KLL in vse cikle FL
In clinical studies with Gazyvaro, doses ranging from 50 mg up to and including 2,000 mg per infusion have been administered. 
V kliničnih študijah zdravila Gazyvaro so uporabili odmerke od 50 mg do (in vključno) 2000 mg na infuzijo.
In patients who received the recommended measures for prevention of IRRs as described in section 4.2, a decreased incidence of IRRs of all Grades was observed. 
Pri bolnikih, ki so prejeli priporočene ukrepe za preprečitev reakcij, povezanih z infuzijo, kot je opisano v poglavju 4.2, je to zmanjšalo incidenco reakcij, povezanih z infuzijo, vseh stopenj.
Gazyvaro contains the active substance obinutuzumab, which belongs to a group of medicines called “monoclonal antibodies”. 
Zdravilo Gazyvaro vsebuje učinkovino obinutuzumab, ki spada v skupino zdravil, imenovanih “monoklonska protitelesa”.
Induction (in combination with bendamustine2) Gazyvaro should be administered in six 28-day cycles in combination with bendamustine2. 
Indukcija (v kombinaciji z bendamustinom2) Zdravilo Gazyvaro se mora aplicirati v šestih 28-dnevnih ciklih v kombinaciji z bendamustinom2.
Prior to enrolment, patients had to have documented CD20+ CLL, and one or both of the following measures of coexisting medical conditions: comorbidity score (CIRS) of greater than 6 or reduced renal function as measured by CrCl < 70 mL/min. 
Pred vključitvijo so morali imeti bolniki potrjeno KLL CD20+ in zadostiti enemu ali obema meriloma za sočasne bolezni: oceno komorbidnosti (CIRS) več kot 6 ali zmanjšano delovanje ledvic z očistkom kreatinina < 70 ml/min.
In nonclinical studies, obinutuzumab induces direct cell death and mediates antibody dependent cellular cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP) through recruitment of FcɣRIII positive immune effector cells. 
V predkliničnih študijah je obinutuzumab induciral neposredno celično smrt in je posredoval od protiteles odvisno celično citotoksičnost (antibody dependent cellular cytotoxicity - ADCC) in od protiteles odvisno celično fagocitozo (antibody dependent cellular phagocytosis - ADCP) s privabljanjem FcɣRIII-pozitivnih imunskih efektorskih celic.
· medicine to prevent tumour lysis syndrome (such as allopurinol). 
• zdravila za preprečevanje sindroma razpada tumorja (kot je alopurinol)
Pharmacokinetic data in patients with severe renal impairment (CrCl 15-29 mL/min) is limited (n=8), therefore no dose recommendations can be made. 
Farmakokinetičnih podatkov za bolnike s hudo ledvično okvaro (očistek kreatinina 15-29 ml/min) je malo (n = 8), zato priporočil za odmerjanje ni mogoče dati.
4.If a corticosteroid-containing chemotherapy regimen is administered on the same day as Gazyvaro, the corticosteroid can be administered as an oral medicinal product if given at least 60 minutes prior to Gazyvaro, in which case additional IV corticosteroid as premedication is not required. 
Če se kemoterapija, ki vključuje kortikosteroid, daje na isti dan kot zdravilo Gazyvaro, se lahko uporabi peroralna oblika k ortikosteroida, če se ga da vsaj 60 minut pred uporabo zdravila Gazyvaro; v tem primeru dodaten kortikosteroid v intravenski obliki kot premedikacija ni potreben.
In CLL patients who received the combined measures for prevention of IRRs (adequate corticosteroid, oral analgesic/anti-histamine, omission of antihypertensive medicine in the morning of the first infusion, and the Cycle 1 Day 1 dose administered over 2 days) as described in section 4.2, a decreased incidence of IRRs of all Grades was observed. 
Pri bolnikih s KLL, ki so bili deležni kombiniranih ukrepov za preprečitev reakcij, povezanih z infuzijo (ustreznih kortikosteroidov, peroralnih analgetikov/antihistaminikov, neuporabe antihipertenzivov na jutro prvega infundiranja ter uporabe odmerka za 1. dan 1. cikla v 2 dneh), kot so opisani v poglavju 4.2, je bila incidenca z infuzijo povezanih reakcij vseh stopenj manjša.
· If you become pregnant during treatment with Gazyvaro, tell your doctor or nurse as soon as possible. 
• Če med zdravljenjem z zdravilom Gazyvaro zanosite, o tem čim prej obvestite zdravnika ali medicinsko sestro.
Other medicines and Gazyvaro 
Druga zdravila in zdravilo Gazyvaro
The incidence and severity of infusion related symptoms decreased substantially after the first 1,000 mg was infused, with most patients having no IRRs during subsequent administrations of Gazyvaro (see section 4.8). 
Incidenca in izrazitost simptomov reakcij, povezanih z infuzijo, se je bistveno zmanjšala po infundiranju prvih 1000 mg in večina bolnikov med nadaljnjo uporabo zdravila Gazyvaro reakcij, povezanih z infuzijo, ni imela (glejte poglavje 4.8).
All subsequent infusions for CLL and FL 
Vsa nadaljnja infundiranja pri KLL in FL
If a planned dose of Gazyvaro is missed, it should be administered as soon as possible; do not wait until the next planned dose. 
V primeru, da bolnik načrtovani odmerek zdravila Gazyvaro izpusti, mu ga je treba dati čim prej; ne čakajte do naslednjega načrtovanega odmerka.
No Grade 5 events of thrombocytopenia were reported. 
O dogodkih trombocitopenije 5. stopnje niso poročali.
Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, assay robustness to quantities of Gazyvaro/antibody in the circulation, sample handling, timing of sample collection, concomitant medicines and underlying disease. 
Rezultati preizkusov imunogenosti so zelo odvisni od številnih dejavnikov, vključno s senzitivnostjo in specifičnostjo preizkusa, metodologijo preizkusa, robustnostjo preizkusov za količino zdravila Gazyvaro v obtoku, ravnanjem z vzorcem, časom odvzema vzorca, sočasnimi zdravili in osnovno boleznijo.
· PML is a very rare and life-threatening brain infection that has been reported in very few patients having treatment with Gazyvaro. 
• Progresivna multifokalna levkoencefalopatija (PML) je zelo redka in smrtno nevarna okužba možganov, o kateri so poročali pri zelo majhnem številu bolnikov, zdravljenih z zdravilom Gazyvaro.
B-cell counts returned to normal levels in the offspring, and immunologic function was restored within 6 months of birth. 
Število celic B se je pri potomstvu normaliziralo in imunološko delovanje obnovilo v 6 mesecih po rojstvu.
Overall, 3% of patients experienced an infusion related reaction leading to discontinuation of Gazyvaro. 
Skupno je imelo 3 % bolnikov reakcijo, povezano z infuzijo, ki je vodila k prekinitvi zdravljenja z zdravilom Gazyvaro.
The clearance of obinutuzumab was approximately 0.11 L/day in CLL patients and 0.08 L/day in iNHL patients with a median elimination t½ of 26.4 days in CLL patients and 36.8 days in iNHL patients. 
Očistek obinutuzumaba je bil približno 0,11 l/dan pri bolnikih s KLL in 0,08 l/dan pri bolnikih z iNHL, mediani eliminacijski t1/2 pa 26,4 dneva pri bolnikih s KLL in 36,8 dneva pri bolnikih z iNHL.
It is strongly recommended that patients with severe neutropenia lasting more than 1 week receive antimicrobial prophylaxis throughout the treatment period until resolution to Grade 1 or 2. 
Za bolnike s hudo nevtropenijo, daljšo od 1 tedna, je zelo priporočljivo dajanje protibakterijske profilakse med zdravljenjem, dokler se nevtropenija ne izboljša na stopnjo 1 ali 2.
Results of subgroup analyses were in general consistent with the results seen in the FL population, supporting the robustness of the overall result. 
Rezultati analiz podskupin Rezultati analiz podskupin so se na splošno skladali z rezultati v populaciji s FL; to potrjuje robustnost skupnega rezultata.
Findings included acute anaphylactic or anaphylactoid reactions and an increased prevalence of systemic inflammation and infiltrates consistent with immune-complex mediated hypersensitivity reactions, such as arteritis/periarteritis, glomerulonephritis, and serosal/adventitial inflammation. 
Izsledki so obsegali akutne anafilaktične in anafilaktoidne reakcije in večjo prevalenco sistemskega vnetja in infiltratov, kar se sklada s preobčutljivostnimi reakcijami, posredovanimi z imunskimi kompleksi, npr. arteritisom/periarteritisom, glomerulonefritisom in vnetjem seroze/adventicije.
Cases of gastro-intestinal perforation have been reported in patients receiving Gazyvaro, mainly in iNHL. 
Pri bolnikih, zdravljenih z zdravilom Gazyvaro, so poročali o primerih gastrointestinalnih perforacij, večinoma pri iNHL.
The B-cell counts returned to normal levels, and immunologic function was restored within 6 months post-partum. 
Število celic B se je normaliziralo in imunološko delovanje se je obnovilo v 6 mesecih po porodu.
Gazyvaro infusions should not be administered as an intravenous push or bolus. 
Infuzij zdravila Gazyvaro se ne sme dati v obliki hitre intravenske infuzije ali kot bolus.
After dilution, chemical and physical stability have been demonstrated in sodium chloride 9 mg/mL (0.9%) solution for injection at concentrations of 0.4 mg/mL to 20 mg/mL for 24 hours at 2°C to 8°C 
Po razredčenju sta kemijska in fizikalna stabilnost dokazani v 0,9-% (9 mg/ml) raztopini natrijevega klorida za injiciranje v koncentracijah od 0,4 mg/ml do 20 mg/ml za 24 ur pri temperaturi od 2 do
For storage conditions of the infusion bags see section 6.3. 
Za pogoje shranjevanja infuzijskih vrečk glejte poglavje 6.3.
Patients who experience neutropenia should be closely monitored with regular laboratory tests until resolution. 
Bolnike, pri katerih se razvije nevtropenija, je treba skrbno nadzirati z rednimi laboratorijskimi kontrolami krvne slike, dokler ne mine.
If a hypersensitivity reaction is suspected during or after an infusion, the infusion must be stopped and treatment permanently discontinued. 
Pri sumu na preobčutljivostno reakcijo med infundiranjem ali po njem je treba infundiranje prekiniti in zdravljenje trajno končati.
In animal models obinutuzumab mediates potent B-cell depletion and antitumour efficacy. 
V živalskih modelih obinutuzumab močno zmanjša število celic B in deluje protitumorsko.
Serious bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of Gazyvaro therapy. 
Med zdravljenjem z zdravilom Gazyvaro in po njem se lahko pojavijo resne bakterijske, glivične in nove ali reaktivirane virusne okužbe.
The incidence of haemorrhagic events was similar across all treatment arms. 
Incidenca hemoragičnih dogodkov je bila med zdravljenima skupinama podobna.
The infusion must be stopped and therapy permanently discontinued if the patient experiences a second occurrence of a Grade 3 IRR. 
Infundiranje je treba ustaviti in zdravljenje trajno končati, če se bolniku še drugič pojavi z infuzijo povezana reakcija 3. stopnje.
Of these patients, none experienced anaphylactic or hypersensitivity reactions that were considered related to ATA, nor was clinical response affected. 
Nobeden od teh bolnikov ni imel anafilaktične ali preobčutljivostne reakcije, ki bi bila ocenjena kot povezana s protiterapevtskimi protitelesi; tudi klinični odziv ni bil spremenjen.
At the start of treatment for FL, Gazyvaro is used together with other medicines for cancer. 
Na začetku zdravljenja folikularnega limfoma zdravilo Gazyvaro uporabljamo skupaj z drugimi zdravili za zdravljenje raka.
Day of treatment 
Dan zdravljenja
However, weekly obinutuzumab dosing from post-coitum day 20 to delivery resulted in complete depletion of B-cells in infant monkeys at weekly intravenous obinutuzumab doses of 25 and 50 mg/kg (2-5 times the clinical exposure based on Cmax and AUC). 
Toda vsakotedenska uporaba od 20. postkoitalnega dne do poroda je pri opičjih mladičih povzročila popolno odsotnost celic B ob tedenskih intravenskih odmerkih obinutuzumaba od 25 do 50 mg/kg (to je od 2- do 5-kratnik klinične izpostavljenosti na podlagi Cmax in AUC).
In repeat-dose toxicity studies in cynomolgus monkeys obinutuzumab had no adverse effects on male and female reproductive organs. 
V študijah toksičnosti ponavljajočih se odmerkov obinutuzumab pri opicah cynomolgus ni imel škodljivega vpliva na reproduktivne organe samcev in samic.
Completed at least 1 hour prior to Gazyvaro infusion 
Dokončano vsaj 1 uro pred infundiranjem zdravila Gazyvaro
Overall Survival (not yet mature) No. (%) of patients with event Median time to event (months) 
Celokupno preživetje (še ni doseženo) Število (%) bolnikov z dogodkom Mediani čas do dogodka (meseci)
· Do not use this medicine after the expiry date which is stated on the carton after EXP. 
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
· Grade 1-2 (mild to moderate): The infusion rate must be reduced and symptoms treated. 
• 1. do 2. stopnja (blage do zmerne): Hitrost infundiranja je treba zmanjšati in zdraviti simptome.
Patients were randomised 1:1 to receive either bendamustine (B) alone (n = 202) or Gazyvaro in combination with bendamustine (G+B) (n = 194) for 6 cycles, each of 28 days duration. 
Bolnike so v razmerju 1:1 randomizirali na prejemanje bodisi samega bendamustina (B) (n = 202) bodisi zdravila Gazyvaro v kombinaciji z bendamustinom (G + B) (n = 194) za 6 28-dnevnih ciklov.
Tell your doctor or nurse if you notice any of the side effects listed above. 
Zdravniku ali medicinski sestri povejte, če opazite katerega koli od zgoraj navedenih neželenih učinkov.
Cycles 2, 3, 4, 5 and 6 this will be just one dose of Gazyvaro in the 28 days: · Day 1 - full dose (1,000 mg). 
2., 3., 4., 5. in 6. cikel - vključujejo le en odmerek zdravila Gazyvaro v 28 dneh: • 1. dan - celoten odmerek (1000 mg).
During the follow-up phase, Grade 3-5 infections are observed more in patients who received Gazyvaro plus bendamustine in the induction phase. 
Med obdobjem spremljanja so dokumentirali več okužb 3. do 5. stopnje pri bolnikih, ki so v fazi indukcije prejemali zdravilo Gazyvaro v kombinaciji z bendamustinom.