natgillin/translations-raw huggingface dataset:
Progressive multifocal leukoencephalopathy (also called “PML”) 
Progresivna multifokalna levkoencefalopatija (imenovana tudi PML)
Pharmacokinetics of obinutuzumab in patients with mild creatinine clearance (CrCl 50-89 mL/min, n=464) or moderate (CrCl 30 to 49 mL/min, n=106) renal impairment were similar to those in patients with normal renal function (CrCl ³ 90 mL/min, n=383). 
Farmakokinetika obinutuzumaba je bila pri bolnikih z blago (očistek kreatinina 50-89 ml/min, n = 464) ali zmerno (očistek kreatinina 30-49 ml/min, n = 106) ledvično okvaro podobna kot pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina ≥ 90 ml/min,
A reproduction study in cynomolgus monkeys showed no evidence of embryofoetal toxicity or teratogenic effects but resulted in a complete depletion of B-lymphocytes in offspring. 
Študija sposobnosti razmnoževanja na opicah cynomolgus ni pokazala znakov embriofetalne toksičnosti ali teratogenih učinkov, ugotovila pa je popolno odsotnost (zmanjšanje števila) limfocitov B pri potomstvu.
Concentrations in infant serum on day 28 post-partum were in the range of concentrations in maternal serum, whereas concentrations in milk on the same day were very low (less than 0.5% of the corresponding maternal serum levels) suggesting that exposure of infants must have occurred in utero. 
28. dan po porodu je bila v razponu koncentracije v materinem serumu, koncentracija v mleku isti dan pa je bila zelo nizka (manj kot 0,5 % ustrezne koncentracije v materinem serumu); to kaže, da je moralo do izpostavljenosti priti in utero.
For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated. 
Med zdravljenjem sindroma razpada tumorja je treba odpraviti nepravilnosti elektrolitov, preverjati delovanje ledvic in ravnovesje tekočin ter uporabiti podporno oskrbo, vključno z dializnim zdravljenjem, kot je indicirano.
In the population pharmacokinetic analysis, gender was found to be a covariate which explains some of the inter-patient variability, with a 22% greater steady state clearance (CLss) and a 19% greater volume of distribution (V) in males. 
Razmerje farmakokinetika/farmakodinamika V analizi populacijske farmakokinetike se je spol izkazal kot sospremenljivka, ki pojasni del variabilnosti med bolniki: pri moških je očistek v stanju dinamičnega ravnovesja (CLss) za 22 % večji,
Patients with known hypersensitivity to obinutuzumab must not be treated (see section 4.3). 
Bolnikov, ki imajo znano preobčutljivost za obinutuzumab, se z njim ne sme zdraviti (glejte poglavje 4.3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common 
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
Table 6 summarises the ADRs of the pivotal studies (BO21004/CLL11, BO21223/GALLIUM 
Preglednica 6 povzema neželene učinke iz ključnih študij (BO21004/CLL11, BO21223/GALLIUM,
The storage details are as follows: · Keep this medicine out of the sight and reach of children. 
Podrobnosti o shranjevanju so: • Zdravilo shranjujte nedosegljivo otrokom!
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za razredčenje
The median OS was not yet reached for either arm. 
Mediana celokupnega preživetja še ni bilo dosežena v nobeni skupini.
Corticosteroid premedication is recommended for patients with FL and mandatory for CLL patients in the first cycle (see Table 1). 
Premedikacija s kortikosteroidom je v prvem ciklu za bolnike s FL priporočljiva, za bolnike s KLL pa obvezna (glejte preglednico 1).
Women of childbearing potential must use effective contraception during and for 18 months after treatment with Gazyvaro. 
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 18 mesecev po zaključku zdravljenja z zdravilom Gazyvaro.
In study BO21223/GALLIUM, 1/565 patient (0.2% of patients with a post-baseline assessment) developed HAHA at induction completion. 
V študiji BO21223/GALLIUM so se pri 1 bolniku od 565 bolnikov (0,2 % od testiranih po začetku zdravljenja) razvila protitelesa HAHA po zaključku indukcije.
Following Cycles 6-8, in combination with chemotherapy, responding patients received Gazyvaro maintenance therapy every 2 months until disease progression or for up to 2 years. 
Po 6. ali 8. ciklu v kombinaciji s kemoterapijo so odzivni bolniki prejeli vzdrževalno zdravljenje z zdravilom Gazyvaro vsaka 2 meseca do napredovanja bolezni ali največ 2 leti.
Beyond Cycle 1 the incidence of IRRs in subsequent infusions was comparable between the Gazyvaro and the relevant comparator arms. 
V nadaljnjih infundiranjih po 1. ciklu je bila incidenca reakcij, povezanih z infuzijo, med zdravilom Gazyvaro in ustreznim primerjalnim zdravilom primerljiva.
The safety and efficacy of Gazyvaro has not been established in patients with severe renal impairment (CrCl < 30 mL/min) (see sections 4.8 and 5.2). 
Varnost in učinkovitost zdravila Gazyvaro pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) nista ugotovljeni (glejte poglavji 4.8 in 5.2).
Patients with inadequate liver function (National Cancer Institute - Common Terminology Criteria for Adverse Events Grade 3 liver function tests (AST, ALT > 5 x ULN for > 2 weeks; bilirubin > 3 x ULN) and renal function (CrCl < 30 mL/min) were excluded. 
Cancer Institute - Common Terminology Criteria for Adverse Events (AST, ALT > 5 x zgornje normalne meje > 2 tedna; bilirubin > 3 x zgornje normalne meje) in delovanjem ledvic (očistek kreatinina < 30 ml/min) so bili izključeni.
A total of 781 patients were randomised 2:2:1 to receive Gazyvaro plus chlorambucil, rituximab plus chlorambucil or chlorambucil alone. 
V celoti so 781 bolnikov v razmerju 2 : 2 : 1 randomizirali na prejemanje kombinacije zdravila Gazyvaro in klorambucila, kombinacije rituksimaba in klorambucila ali samega klorambucila.
No formal pharmacokinetic study has been conducted in patients with hepatic impairment. 
Formalnih farmakokinetičnih študij pri bolnikih z jetrno okvaro niso izvedli.
The population pharmacokinetic analysis of obinutuzumab showed that creatinine clearance does not affect pharmacokinetics of obinutuzumab. 
Populacijska farmakokinetična analiza obinutuzumaba je pokazala, da očistek kreatinina ne vpliva na farmakokinetiko obinutuzumaba.
Two infusion bags should be prepared for the infusion on Days 1 and 2 (100 mg for Day 1 and 900 mg for Day 2). 
Za infundiranje 1. in 2. dan je treba pripraviti dve infuzijski vrečki (100 mg za 1. dan in 900 mg za
Results of the progression free survival (PFS) subgroup analysis (i.e. sex, age, Binet stages, CrCl, CIRS score, beta2-microglobulin, IGVH status, chromosomal abnormalities, lymphocyte count at baseline) were consistent with the results seen in the overall Intent-to-Treat population. 
Rezultati analize preživetja brez napredovanja bolezni (PFS) po podskupinah (tj. spol, starost, stadij po Binetu, očistek kreatinina, ocena CIRS, beta2-mikroglobulin, stanje IGVH, kromosomske nepravilnosti, izhodiščno število limfocitov) so se skladali z rezultati, ugotovljenimi v celotni populaciji z-namenom-zdravljenja.
· If you had any of these symptoms before treatment with Gazyvaro, tell your doctor straight away if you notice any changes in them. 
• Če ste imeli kateri koli opisani simptom že pred zdravljenjem z zdravilom Gazyvaro, zdravniku takoj povejte, če opazite kakršno koli spremembo teh simptomov.
Do not use other diluents such as glucose (5%) solution. 
Ne uporabljajte drugih raztopin za redčenje, npr. 5-% raztopine glukoze.
· Keep the container in the outer carton in order to protect from light. 
• Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
The observed HRs by chemotherapy subgroup were as follows; CHOP (n = 398): HR 0.77 (95% CI: 0.50, 1.20), CVP (n = 118): HR 0.63 (95% CI: 0.32, 1.21), and bendamustine (n = 686): HR 0.61 (95% CI: 0.43, 0.86). 
(95-% IZ: 0,50; 1,20), CVP (n = 118): RO 0,63 (95-% IZ: 0,32; 1,21) in bendamustin (n = 686): RO 0,61 (95-% IZ: 0,43; 0,86).
After dilution 
Po razredčenju
The number of fatal haemorrhagic events was balanced between the treatment arms; however, all of the events in patients treated with Gazyvaro were reported in Cycle 1. 
Število krvavitev s smrtnim izidom je bilo med skupinama uravnoteženo, a vsi dogodki med prejemniki zdravila Gazyvaro so se pojavili v 1. ciklu.
Cycle 
Cikel
Before each infusion of Gazyvaro, you will be given medicines to lessen the chance of getting infusion related reactions or tumour lysis syndrome. 
Pred vsakim infundiranjem zdravila Gazyvaro boste dobili zdravila, ki pomagajo zmanjšati možnost nastanka reakcij, povezanih z infuzijo, ali sindroma razpada tumorja.
Common (may affect up to 1 in 10 people) 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
At least 30 minutes before Gazyvaro infusion 
Vsaj 30 minut pred infundiranjem zdravila Gazyvaro
Patients were randomised to 1:1 to receive either Gazyvaro (n=601 patients) or rituximab (n=601 patients) in combination with chemotherapy (bendamustine, CHOP or CVP), followed by Gazyvaro or rituximab maintenance in patients achieving a complete or partial response. 
Bolnike so randomizirali v razmerju 1:1 na prejemanje zdravila Gazyvaro (n = 601 bolnikov) ali rituksimaba (n = 601 bolnikov) v kombinaciji s kemoterapijo (bendamustin, CHOP ali CVP), čemur je pri bolnikih s popolnim ali delnim odgovorom sledilo vzdrževalno zdravljenje z zdravilom Gazyvaro ali rituksimabom.
· If you have any further questions, ask your doctor or nurse. 
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali medicinsko sestro.
18.7 months median observation time g 
18,7 meseca g
At baseline, 22% of patients had Binet Stage A, 42% had Binet Stage B and 36% had Binet Stage C. 
Izhodiščno je imelo 22 % stadij A po Binetu, 42 % stadij B po Binetu in 36 % stadij C po Binetu.
If you had any of these symptoms before treatment with Gazyvaro, tell your doctor straight away if you notice any changes in them. 
Če ste imeli katere koli simptome že pred zdravljenjem z zdravilom Gazyvaro, zdravniku takoj povejte, če opazite kakršno koli spremembo teh simptomov.
Serum concentrations of obinutuzumab in offspring were similar to those in the mothers on day 28 post-partum, whereas concentrations in milk on the same day were very low, suggesting that obinutuzumab crosses the placenta (see section 5.3). 
Koncentracija obinutuzumaba v serumu pri potomcih 28. dan po porodu je bila podobna kot pri materah, koncentracija v mleku istega dne pa je bila zelo majhna, kar kaže, da obinutuzumab prehaja skozi placento (glejte poglavje 5.3).
In patients with FLIPI score 0-1 (low risk), no difference between Gazyvaro plus chemotherapy and rituximab plus chemotherapy was observed (INV-assessed PFS HR 1.17 (95%CI 0.63;2.19, 40 PFS events). 
Pri bolnikih z rezultatom točkovalnika FLIPI 0-1 (nizko tveganje) niso opazili razlik med skupino, ki je prejemala zdravilo Gazyvaro in kemoterapijo, ter skupino, ki je prejemala rituksimab in kemoterapijo (PFS po raziskovalčevi oceni z RO 1,17 (95-% IZ 0,63; 2,19, 40 primerov PFS).
A Phase III international, multicentre, open label, randomised, two-stage, three-arm clinical study (BO21004/CLL11) investigating the efficacy and safety of Gazyvaro plus chlorambucil (GClb) compared to rituximab plus chlorambucil (RClb) or chlorambucil (Clb) alone was conducted in patients with previously untreated CLL with comorbidities. 
Mednarodna, multicentrična, odprta, randomizirana, dvostopenjska klinična študija faze III s tremi skupinami (BO21004/CLL11) za preučitev učinkovitosti in varnosti kombinacije zdravila Gazyvaro in klorambucila (G-Clb) v primerjavi s kombinacijo rituksimaba in klorambucila (R-Clb) ter s klorambucilom (Clb) je bil izvedena pri bolnikih s še nezdravljeno KLLin komorbidnimi stanji.
During the maintenance period in study GAO4753g/GADOLIN, the most common adverse reactions were cough (15%), upper respiratory infections (12%), neutropenia (11%), sinusitis (10%), diarrhoea (8%), IRRs (8%), nausea (8%), fatigue (8%), bronchitis (7%), arthralgia (7%), pyrexia (6%), nasopharyngitis (6%), and urinary tract infections (6%). 
V obdobju vzdrževalnega zdravljenja v študiji GAO4753g/GADOLIN so bili najbolj pogosti neželeni učinki kašelj (15 %), okužba zgornjih dihal (12 %), nevtropenija (11 %), sinuzitis (10 %), diareja (8 %), reakcije, povezane z infuzijo (8 %), navzea (8 %), utrujenost (8 %), bronhitis (7 %), artralgija (7 %), zvišana telesna temperatura (6 %), nazofaringitis (6 %) in okužbe sečil (6 %).
The studies BO21223/GALLIUM and GAO4753g/GADOLIN enrolled patients with iNHL including FL. 
V študijah BO21223/GALLIUM in GAO4753g/GADOLIN so bili vključeni bolniki z iNHL,
Based on the FACT-Lym questionnaire collected during treatment and follow-up phases, patients in both treatment arms experienced clinically meaningful improvements in lymphoma-related symptoms as defined by a ³ 3 point increase from baseline in the Lymphoma subscale, a ³ 6 point increase from baseline in the FACT Lym TOI and a ³ 7 point increase from baseline in the FACT Lym Total score. 
Izidi po navedbi bolnika Na podlagi vprašalnika FACT-Lym, uporabljenega med zdravljenjem in obdobjem spremljanja, so se pri bolnikih iz obeh zdravljenih skupin simptomi, povezani z limfomom, klinično pomembno izboljšali, kot določa zvečanje za ≥ 3 točke od izhodišča na podlestvici za limfome, zvečanje za ≥ 6 točk od izhodiščne ocene FACT-Lym TOI in zvečanje za ≥ 7 točk od izhodiščne skupne ocene FACT-Lym.
The incidences presented in the following sections if referring to iNHL are the highest incidence of that ADR reported from either pivotal study (BO21223/GALLIUM, GAO4753g/GADOLIN). 
V spodnjih poglavjih navedene incidence, ki se nanašajo na iNHL, so najvišje incidence neželenih učinkov, ki so jih poročali ali iz ene ali iz druge ključne študije (BO21223/GALLIUM, GAO4753g/GADOLIN).
In addition, there were no apparent effects of bendamustine, FC, chlorambucil or CHOP on the pharmacokinetics of Gazyvaro. 
Dodatno ni bilo vidnih učinkov bendamustina, FC, klorambucila ali CHOP na farmakokinetiko zdravila Gazyvaro.
A type of liver disease called “hepatitis B” has also been reported to reoccur in patients who have had hepatitis B in the past. 
Pri bolnikih, ki so imeli v preteklosti vrsto jetrne bolezni, imenovane hepatitis B, je bila opisana ponovitev hepatitisa B.
1100 mg prednisone/prednisolone or 20 mg dexamethasone or 80 mg methylprednisolone. 
1 100 mg prednizona/prednizolona ali 20 mg deksametazona ali 80 mg metilprednizolona.
Efficacy results for patients with previously untreated CLL are summarised in Table 7. 
Rezultati učinkovitosti za bolnike s še nezdravljeno KLL so povzeti v preglednici 7.
EQ-5D utility scores were similar at baseline, during treatment and follow-up. 
Rezultati uporabnosti, merjeni z vprašalnikom za merjenje uporabnosti EQ-5D, so bili podobni v izhodišču, med zdravljenjem in obdobjem spremljanja.
In total, six cycles of Gazyvaro (every 28 days) were given in combination with six cycles of bendamustine, and a total of eight cycles of Gazyvaro (every 21 days) were given in combination with six cycles of CHOP or eight cycles of CVP. 
Skupno so dali šest ciklov zdravila Gazyvaro (vsakih 28 dni) v kombinaciji s šestimi cikli bendamustina ali osem ciklov zdravila Gazyvaro (vsakih 21 dni) v kombinaciji s šestimi cikli CHOP ali osmimi cikli CVP.
For subgroups, reduction of the risk of disease progression or death ranged from 92% to 58% for GClb versus Clb and 72% to 29% for GClb versus RClb. 
Po podskupinah je zmanjšanje tveganja za napredovanje bolezni ali za smrt segalo od 92 % do 58 % v skupini, ki je prejemala zdravilo Gazyvaro in klorambucil v primerjavi s klorambucilom samim in od 72 % do 29 % v skupini, ki je prejemala zdravilo Gazyvaro in klorambucil v primerjavi s skupino, ki je prejemala rituksimab in klorambucil.
The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered on Day 1 of each cycle. 
Priporočeni odmerek zdravila Gazyvaro v kombinaciji s klorambucilom je 1000 mg, uporabljen 1. dan vsakega cikla.
Chlorambucil N=118 
2. faza klorambucil n = 118
Motor symptoms with corticospinal tract findings (e.g. muscular weakness, paralysis and sensory disturbances), sensory abnormalities, cerebellar symptoms, and visual field defects are common. 
Pogosti so motorični simptomi s prizadetostjo kortikospinalnega trakta (npr. mišična šibkost, paraliza in senzorične motnje), senzorične nepravilnosti, cerebelarni simptomi in izpadi vidnega polja.
The most frequently reported coexisting medical conditions (using a cut off of 30% or higher), in the MedDRA body systems are: Vascular disorders (73%), Cardiac disorders (46%), Gastrointestinal disorders (38%), Metabolism and nutrition disorders (40%), Renal and urinary disorders (38%), Musculoskeletal and connective tissue disorders (33%). 
Najpogosteje zabeležena sočasna bolezenska stanja (z uporabo meje 30 % ali več) po organskih sistemih MedDRA so bila: žilne bolezni (73 %), srčne bolezni (46 %), bolezni prebavil (38 %), presnovne in prehranske motnje (40 %), bolezni sečil (38 %), bolezni mišično-skeletnega sistema in vezivnega tkiva (33 %).
Median was not reached at time of analysis # not adjusted for multiplicity **Assessed as per modified Cheson 2007 criteria ‡ End of Induction = end of induction phase, does not include monotherapy maintenance 
Neprilagojeno glede multiplicitete **Ocenjeno po modificiranem kriteriju Cheson 2007
In a 26-week cynomolgus monkey study, hypersensitivity reactions were noted and attributed to the foreign recognition of the humanised antibody in cynomolgus monkeys (0.7-6 times the clinical exposure based on Cmax and AUC at steady state after weekly administration of 5, 25, and 50 mg/kg). 
V 26-tedenski študiji na opicah cynomolgus so zabeležili preobčutljivost, ki so jo pripisali prepoznavi humaniziranega protitelesa pri opicah cynomolgus kot tujka (0,7- do 6-kratna klinična izpostavljenost na podlagi Cmax in AUC v stanju dinamičnega ravnovesja po vsakotedenski uporabi 5, 25 in
Grade 3-4 IRRs occurred in 12% of patients. 
Reakcije, povezane z infuzijo, 3. do 4. stopnje so se pojavile pri 12 % bolnikov.
· When Gazyvaro is given to patients with CLL or FL together with other medicines for cancer - this slows down the time it takes for their disease to get worse. 
• Ko zdravilo Gazyvaro uporabljajo bolniki s kronično limfocitno levkemijo in folikularnim limfomom skupaj z drugimi zdravili za zdravljenje raka, to podaljša obdobje do poslabšanja bolezni.
What Gazyvaro looks like and contents of the pack 
Izgled zdravila Gazyvaro in vsebina pakiranja
Management of IRRs (all indications) 
Obvladovanje reakcij, povezanih z infuzijo (vse indikacije)
Data during follow up, especially for the chlorambucil alone arm, is limited. 
Podatkov iz obdobja spremljanja je malo, še zlasti za skupino, ki je dobivala samo klorambucil.
Hypersensitivity may be difficult to clinically distinguish from IRRs. 
Preobčutljivost je včasih težko klinično ločiti od reakcij, povezanih z infuzijo.
The rates of Grade 3-4 IRRs (which occurred in relatively few patients) were similar before and after mitigation measures were implemented. 
Pogostnost reakcij, povezanih z infuzijo, 3. do 4. stopnje (ki se je pojavila pri relativno majhnem številu bolnikov) je bila podobna pred in po uvedbi ukrepov za blažitev.
In the pivotal BO21004/CLL11 study, 46% (156 out of 336) of patients with CLL treated with Gazyvaro plus chlorambucil were 75 years or older (median age was 74 years). 
V ključni študiji BO21004/CLL11 je bilo 46 % (156 od 336) bolnikov s KLL, zdravljenih s kombinacijo zdravila Gazyvaro in klorambucila, starih 75 let ali več (mediana starosti je bila 74 let).
Cycle 1 
1. cikel
For CLL patients receiving the Day 1 (Cycle 1) dose split over two days, the Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour, but not increased further. 
Za bolnike s KLL lahko odmerek 1. dne (1. cikla) razdelite na dva dni, hitrost infundiranja je mogoče 1. dan (1. cikla) po 1 uri spet povečati na 25 mg/uro, ne sme pa se je povečati bolj.
HBVscreening should be performed in all patients before initiation of treatment with Gazyvaro. 
Pred začetkom zdravljenja z zdravilom Gazyvaro je treba pri vseh bolnikih opraviti presejalno testiranje za HBV.
Table 8 Summary of efficacy in patients with previously untreated FL from BO21223/ GALLIUM study 
Povzetek o učinkovitosti pri bolnikih s predhodno nezdravljenim FL iz študije BO21223/študija GALLIUM
Patients with previously untreated follicular lymphoma 
Bolniki s predhodno nezdravljenim folikularnim limfomom
Cycle 1: Day 1 for CLL and FL 
1. dan pri KLL in FL
The most common Grade 3-5 adverse reactions were neutropenia (10%), and anaemia, febrile neutropenia, thrombocytopenia, sepsis, upper respiratory tract infection, and urinary tract infection (all at 1%). 
Najbolj pogosti neželeni učinki stopnje 3-5 so bili nevtropenija (10 %) in anemija, febrilna nevtropenija, trombocitopenija, sepsa, okužba zgornjih dihal in okužbe sečil (vsi 1 %).
In the pivotal studies (BO21223/GALLIUM, GAO4753g/GADOLIN) in iNHL, 5% (35 out of 698) and 8% (15 out of 194) of patients treated with Gazyvaro, respectively, had moderate renal impairment (CrCL < 50 mL/min). 
V ključnih študijah (BO21223/GALLIUM, GAO4753g/GADOLIN) pri iNHL je imelo 5 % bolnikov (35 od 698) in 8 % bolnikov (15 od 194), zdravljenih z zdravilom Gazyvaro, zmerno ledvično okvaro (očistek kreatinina < 50 ml/min).
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of Gazyvaro as outlined below. 
Obvladovanje reakcij, povezanih z infuzijo, lahko zahteva začasno prekinitev infundiranja, zmanjšanje hitrosti infundiranja ali prenehanje zdravljenja z zdravilom Gazyvaro, kot je prikazano spodaj.
Glycoengineering of the Fc part of obinutuzumab results in higher affinity for FcɣRIII receptors on immune effector cells such as natural killer (NK) cells, macrophages and monocytes as compared to non-glycoengineered antibodies. 
Glikoinženirska obdelava dela Fc obinutuzumabu v primerjavi s protitelesi, ki niso glikoinženirsko obdelana, poveča afiniteto za receptorje FcɣRIII na imunskih efektorskih celicah, kakršne so naravne celice ubijalke (natural killer cells - NK), makrofagi in monociti.
Day of treatment cycle 
Dan cikla zdravljenja
Patients with a Grade 3 IRR with the previous infusion OR Patients with lymphocyte counts >25 x 109/L prior to next treatment 
Bolniki, ki so imeli med prejšnjim infundiranjem reakcijo, povezano z infuzijo, 3. stopnje, ALI bolniki s številom limfocitov > 25 x 109/l pred naslednjim zdravljenjem
These trials investigated Gazyvaro in combination with chlorambucil for CLL and with bendamustine, CHOP or CVP followed by Gazyvaro maintenance therapy for iNHL. 
V teh preskušanjih so proučevali zdravilo Gazyvaro v kombinacijah s klorambucilom pri KLL in bendamustinom, CHOP ali CVP, čemur je sledilo vzdrževalno zdravljenje z zdravilom Gazyvaro, pri iNHL.
The rates of Grade 3-4 IRRs (which were based on a relatively small number of patients) were similar before and after mitigation measures were implemented. 
Deleži z infuzijo povezanih reakcij 3. do 4. stopnje (ki temeljijo na razmeroma majhnem številu bolnikov) so bili pred uvedbo ukrepov za ublažitev in po tem podobni.
These patients experienced more serious adverse events, adverse events leading to death and adverse events leading to treatment withdrawal than patients with a CrCl ≥ 50 mL/min (see section 4.2 and 5.2). 
Ti bolniki so imeli več resnih neželenih dogodkov, neželenih dogodkov, ki so povzročili smrt, in neželenih dogodkov, ki so povzročili ukinitev zdravljenja, kot bolniki z očistkom kreatinina ≥ 50 ml/min (glejte poglavji 4.2 in 5.2).
Table 6 Summary of ADRs reported with a higher incidence (difference of ≥2% versus the comparator arm) in patients# receiving Gazyvaro + chemotherapy* System organ class 
Povzetek neželenih učinkov, zabeleženih z večjo incidenco (razlika ≥ 2 % glede na primerjalno skupino)# med prejemniki zdravila Gazyvaro + kemoterapije*