FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to reduce the rate of infusion related reactions in patients, an amendment was implemented and 140 patients received the first Gazyvaro dose administered over 2 days (Day 1 [100 mg] and Day 2 [900 mg]) (see section 4.2 and 4.4).
Croatian: Kako bi se smanjila stopa s infuzijom povezanih reakcija u bolesnika, u plan ispitivanja uvedena je izmjena pa je 140 bolesnika prvu dozu lijeka Gazyvaro primilo tijekom 2 dana (1. dan [100 mg] i 2. dan [900 mg]) (vidjeti dijelove 4.2 i 4.4).
English: Discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy should also be considered.
Croatian: Dolazi također u obzir obustaviti primjenu ili smanjiti dozu svih konkomitantnih kemoterapijskih ili imunosupresivnih lijekova.
English: Pharmacokinetic data in patients with severe renal impairment (CrCl 15-29 mL/min) is limited (n=8), therefore no dose recommendations can be made.
Croatian: Farmakokinetički podaci u bolesnika s teškim oštećenjem funkcije bubrega (CrCl 15-29 ml/min) su ograničeni (n=8), pa nisu moguće preporuke o doziranju.
English: 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
Croatian: Tablica 6 Sažetak nuspojava prijavljenih s većom incidencijom (razlika od ≥ 2% u odnosu na usporednu skupinu) u bolesnika# koji su primali Gazyvaro + kemoterapiju* Klasifikacija organskih sustava
English: For storage conditions of the infusion bags see section 6.3.
Croatian: Uvjete čuvanja infuzijskih vrećica vidjeti u dijelu 6.3.
English: Gazyvaro is for intravenous use.
Croatian: Gazyvaro je namijenjen za intravensku primjenu.
English: · 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.
Croatian: · Nakon ovog uvodnog liječenja slijedi 'terapija održavanja' - u tom ćete razdoblju primati lijek Gazyvaro svaka 2 mjeseca tijekom najviše 2 godine ili dok ne dođe do pogoršanja bolesti.
English: · Grade 4 (life threatening): Infusion must be stopped and therapy must be permanently discontinued.
Croatian: · Reakcija 4. stupnja (opasna po život): infuzija se mora prekinuti, a terapija trajno obustaviti.
English: Patients should be closely monitored for thrombocytopenia, especially during the first cycle; regular laboratory tests should be performed until the event resolves, and dose delays should be considered in case of severe or life-threatening thrombocytopenia.
Croatian: Bolesnike je potrebno strogo nadzirati zbog moguće pojave trombocitopenije, osobito tijekom prvog ciklusa; potrebno je redovito provoditi laboratorijske pretrage do normalizacije broja trombocita, a u slučajevima teške ili po život opasne trombocitopenije dolazi u obzir odgoda primjene doze.
English: 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.
Croatian: Istraživanje učinka lijeka na reprodukciju makaki majmuna nije ukazalo na embriofetalnu toksičnost niti teratogene učinke, ali je dovelo do potpune deplecije B limfocita u mladunčadi.
English: Gazyvaro should not be administered in the presence of an active infection and caution should be exercised when considering the use of Gazyvaro in patients with a history of recurring or chronic infections.
Croatian: Infekcije Gazyvaro se ne smije primjenjivati ako bolesnik ima aktivnu infekciju, i potreban je oprez kad se razmatra primjena lijeka Gazyvaro u bolesnika s rekurentnim ili kroničnim infekcijama u anamnezi.
English: Patients who received G-CSF prophylaxis had a lower rate of Grade 3-5 infections (see section 4.4).
Croatian: Bolesnici koji su primili G-CSF za profilaksu imali su nižu stopu infekcija 3. - 5. stupnja (vidjeti dio 4.4).
English: For instructions on dilution of Gazyvaro before administration, see section 6.6.
Croatian: Za upute o razrjeđivanju lijeka Gazyvaro prije primjene vidjeti dio 6.6.
English: Follicular lymphoma (FL)
Croatian: Folikularni limfom (FL)
English: No experience with overdose is available from human clinical studies.
Croatian: Nema iskustva s predoziranjem iz kliničkih ispitivanja s ljudima.
English: 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).
Croatian: Bolesnici ne smiju nastaviti primati infuzije lijeka Gazyvaro: · ako se pojave po život opasni respiratorni simptomi, · ako nastupi reakcija na infuziju 4. stupnja (tj. opasna po život) ili · ako ponovno nastupi (dugotrajna/rekurentna) reakcija na infuziju 3. stupnja (nakon nastavka prve infuzije ili tijekom neke sljedeće infuzije).
English: 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).
Croatian: Incidencije navedene u sljedećim odlomcima, ako se odnose na iNHL, predstavljaju najviše incidencije tih nuspojava prijavljene u bilo kojem od dvaju ključnih ispitivanja (BO21223/GALLIUM; GAO4753g/GADOLIN).
English: The studies BO21223/GALLIUM and GAO4753g/GADOLIN enrolled patients with iNHL including FL.
Croatian: U ispitivanja BO21223/GALLIUM i GAO4753g/GADOLIN uključeni su bolesnici s iNHL-om, uključujući FL.
English: 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.
Croatian: Rezultati analize preživljenja bez progresije bolesti (PFS) po podskupinama (tj. spol, dob, stadij bolesti prema Binetu, CrCl, CIRS rezultat, beta2-mikroglobulin, IGVH status, kromosomske abnormalnosti, početni broj limfocita) bili su u skladu s rezultatima zabilježenima u ukupnoj populaciji koju se namjeravalo liječiti (engl.
English: 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).
Croatian: Farmakokinetika obinutuzumaba u bolesnika s blagim klirensom kreatinina [CrCl] 50-89 ml/min, n=464) ili umjerenim (CrCl 30-49 ml/min, n=106) oštećenjem funkcije bubrega bila je slična onoj u bolesnika s normalnom funkcijom bubrega (CrCl ³ 90 ml/min, n=383).
English: · If you have any further questions, ask your doctor or nurse.
Croatian: · Ako imate dodatnih pitanja, obratite se liječniku ili medicinskoj sestri.
English: The infusion must be stopped and therapy permanently discontinued if the patient experiences a second occurrence of a Grade 3 IRR.
Croatian: Infuzija se mora prekinuti, a liječenje trajno obustaviti ako u bolesnika ponovno nastupi reakcija na infuziju 3. stupnja.
English: Tell your doctor or nurse straight away if you have · memory loss · trouble speaking · difficulty walking · problems with your eyesight
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako primijetite · gubitak pamćenja · poteškoće s govorom · poteškoće s hodanjem
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,000 mg/40 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1000 mg/40 ml
English: The diagnosis of PML should be considered in any patient presenting with new-onset or changes to pre-existing neurologic manifestations.
Croatian: Na PML je potrebno posumnjati u svih bolesnika u kojih se pojave novi ili promijene već postojeći neurološki simptomi.
English: · Grade 3 (severe): Infusion must be temporarily stopped and symptoms treated.
Croatian: · Reakcija 3. stupnja (teška): infuzija se mora privremeno prekinuti, a simptomi zbrinuti.
English: 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.
Croatian: Broj događaja smrtonosnih krvarenja bio je podjednak u obje liječene skupine; međutim, svi događaji zabilježeni u bolesnika liječenih lijekom Gazyvaro prijavljeni su u 1. ciklusu.
English: As treatment continues, the impact of this pathway diminishes and the linear clearance pathway predominates.
Croatian: S nastavkom liječenja, učinak tog puta sve je manji i dominantan postaje put linearnog klirensa.
English: 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.
Croatian: U bolesnika u kojih su provedene preporučene mjere za sprječavanje reakcija na infuziju na način opisan u dijelu 4.2, primijećena je smanjena incidencija reakcija na infuziju svih stupnjeva.
English: In addition, in vivo, obinutuzumab mediates a low degree of complement dependent cytotoxicity (CDC).
Croatian: Osim toga, in vivo obinutuzumab manjim dijelom posreduje u citotoksičnosti ovisnoj o komplementu (engl. complement dependent cytotoxicity, CDC).
English: 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.
Croatian: Tijekom prve infuzije lijeka Gazyvaro vrlo često se javljaju reakcije na infuziju, pa je bolesnicima koji imaju simptome povezane s primjenom infuzije potrebno savjetovati da ne upravljaju vozilima i ne rade sa strojevima dok se simptomi ne povuku.
English: In study BO21223/GALLIUM, 1/565 patient (0.2% of patients with a post-baseline assessment) developed HAHA at induction completion.
Croatian: U ispitivanju BO21223/GALLIUM, 1/565 bolesnika (0,2% bolesnika u kojih je provedena ocjena nakon početka liječenja) razvio je HAHA nakon završetka uvodnog liječenja.
English: The incidence of haemorrhagic events was similar across all treatment arms.
Croatian: Incidencija događaja krvarenja bila je slična u svim liječenim skupinama.
English: Kaplan-Meier curves for progression-free survival (PFS) and Overall Survival (OS) are shown in Figures 1-4.
Croatian: Kaplan-Meierove krivulje za preživljenje bez progresije bolesti (engl. progression-free survival, PFS) i ukupno preživljenje (engl. overall survival, OS) prikazane su na Slikama 1-4.
English: 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.
Croatian: Rezultati testova imunogenosti uvelike ovise o nekoliko čimbenika, uključujući osjetljivost i specifičnost testa, metodologiju testiranja, robusnost testa s obzirom na količinu lijeka Gazyvaro u cirkulaciji, rukovanje uzorcima, vrijeme prikupljanja uzoraka, istodobnu primjenu drugih lijekova i osnovnu bolest.
English: Fifty-seven percent received bendamustine, 33% received CHOP, and 10% received CVP chemotherapy.
Croatian: Pedeset i sedam posto (57%) bolesnika primalo je bendamustin, 33% protokol CHOP, a 10% protokol CVP.
English: Data during follow up, especially for the chlorambucil alone arm, is limited.
Croatian: Podaci tijekom praćenja su ograničeni, osobito za skupinu liječenu samo klorambucilom.
English: 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.
Croatian: Obinutuzumab je humanizirano anti-CD20 monoklonsko protutijelo tipa II iz podskupine IgG1 dobiveno humanizacijom osnovnog mišjeg protutijela B-Ly1 i proizvedeno tehnologijom rekombinantne DNK na staničnoj liniji jajnika kineskog hrčka.
English: METHOD OF ADMINISTRATION For intravenous use after dilution
Croatian: Za intravensku primjenu nakon razrjeđivanja
English: For these reasons, comparison of incidence of antibodies to Gazyvaro with the incidence of antibodies to other products may be misleading.
Croatian: Zbog toga usporedba incidencije protutijela na Gazyvaro s incidencijom protutijela na druge lijekove može dovesti do krivih zaključaka.
English: 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.
Croatian: U bolesnika s teškom neutropenijom koja traje dulje od tjedan dana preporučuje se antimikrobna profilaksa tijekom čitavog razdoblja liječenja, sve dok se neutropenija ne ublaži do 1. ili 2. stupnja.
English: increase in potassium, phosphate or uric acid - which can cause kidney problems (part of tumour lysis syndrome)
Croatian: - povišene razine kalija, fosfata ili mokraćne kiseline - mogu uzrokovati bubrežne tegobe (dio sindroma lize tumora) - snižene razine kalija
English: 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.
Croatian: Ako bolesnik propusti primiti planiranu dozu lijeka Gazyvaro, potrebno ju je primijeniti što je prije moguće; ne smije se preskočiti dozu ili čekati do sljedeće planirane doze.
English: Results of subgroup analyses (not adjusted for multiplicity) were, in general, consistent with the results seen in the FL population, supporting the robustness of the overall result.
Croatian: Rezultati analiza podskupina (koji nisu prilagođeni za multiplicitet) u načelu su bili sukladni rezultatima zabilježenima u populaciji s FL-om, što govori u prilog robusnosti cjelokupnog rezultata.
English: The profile of adverse reactions in patients with FL was consistent with the overall iNHL population in both studies.
Croatian: Profil nuspojava u bolesnika s FL-om bio je u skladu s profilom u cjelokupnoj populaciji bolesnika s iNHL-om u oba ispitivanja.
English: Offspring exposure on day 28 post-partum suggests that obinutuzumab can cross the blood-placenta barrier.
Croatian: Izloženost mladunčadi 28 dana nakon okota pokazuje da obinutuzumab može proći kroz krvno-placentarnu barijeru.
English: 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%).
Croatian: Najčešće prijavljene istodobne bolesti (učestalost od 30% ili više) u organskim sustavima prema MedDRA klasifikaciji bile su: krvožilni poremećaji (73%), srčani poremećaji (46%), poremećaji probavnog sustava (38%), poremećaji metabolizma i prehrane (40%), poremećaji bubrega i mokraćnog sustava (38%), poremećaji mišićno-koštanog sustava i vezivnog tkiva (33%).
English: 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.
Croatian: Klirens obinutuzumaba iznosio je približno 0,11 l/dan u bolesnika s KLL-om te 0,08 l/dan u bolesnika s iNHL-om, uz medijan poluvijeka eliminacije od 26,4 dana u bolesnika s KLL-om i 36,8 dana u bolesnika s iNHL-om.
English: Overall, 3% of patients experienced an infusion related reaction leading to discontinuation of Gazyvaro.
Croatian: Sveukupno je 3% bolesnika imalo reakciju povezanu s infuzijom koja je dovela do prekida liječenja lijekom Gazyvaro.
English: Based on a subgroup analysis in previously untreated follicular lymphoma, the efficacy in FLIPI low risk (0-1) patients is currently inconclusive (see section 5.1).
Croatian: Na temelju analize podskupina kod bolesnika s prethodno neliječenim folikularnim limfomom, trenutno se ne može zaključiti o djelotvornosti kod bolesnika kod kojih je FLIPI indeks 0 - 1 (nizak rizik).
English: Patients with one or more individual organ/system impairment score of 4 as assessed by the CIRS definition, excluding eyes, ears, nose, throat and larynx organ system, were excluded.
Croatian: U ispitivanje nisu bili uključeni niti bolesnici koji su prema CIRS kriterijima imali rezultat bodovanja 4 za oštećenje jednog ili više pojedinačnih organa/organskih sustava, osim za oči, uši, nos, grlo i grkljan.
English: At least 30 minutes before Gazyvaro infusion
Croatian: Najmanje 30 minuta prije infuzije lijeka Gazyvaro
English: These patients experienced more serious adverse events and adverse events leading to death than those patients < 75 years of age.
Croatian: U tih su se bolesnika ozbiljnije nuspojave i nuspojave sa smrtnim ishodom javljale češće nego u bolesnika mlađih od 75 godina.
English: Patients who experience overdose should have immediate interruption or reduction of their infusion and be closely supervised.
Croatian: U bolesnika u kojih dođe do predoziranja potrebno je odmah prekinuti infuziju ili smanjiti njezinu brzinu te ih je potrebno pomno nadzirati.
English: † No Grade 5 adverse reactions have been observed with a difference of ≥ 2% between the treatment arms
Croatian: † nije primijećena niti jedna nuspojava 5. stupnja kod koje bi razlika između liječenih skupina bila ≥ 2%
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1,000 mg/40 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 1000 mg/40 ml
English: · Do not breast-feed during treatment with Gazyvaro or for 18 months after stopping treatment with Gazyvaro.
Croatian: · Ne smijete dojiti za vrijeme liječenja lijekom Gazyvaro niti još 18 mjeseci nakon prestanka liječenja.
English: If a planned dose of Gazyvaro is missed, it should be administered as soon as possible; do not wait until the next planned dose.
Croatian: Ako bolesnik propusti primiti planiranu dozu lijeka Gazyvaro, potrebno ju je primijeniti što je prije moguće; ne treba čekati do sljedeće planirane doze.
English: Patients with a Grade 3 IRR with the previous infusion OR Patients with lymphocyte counts >25 x 109/L prior to next treatment
Croatian: Bolesnici s reakcijom na infuziju 3. stupnja kod prethodne infuzije ILI bolesnici s brojem limfocita > 25 x 109/l prije sljedeće primjene lijeka
English: Therefore patients with a history of cardiac disease should be monitored closely.
Croatian: Stoga je bolesnike sa srčanim bolestima u anamnezi potrebno pomno nadzirati.
English: Every 2 months for 2 years or until disease progression (whichever occurs first)
Croatian: Svaka 2 mjeseca tijekom 2 godine ili do progresije bolesti (što god nastupi prije)
English: From the population PK model, after the Cycle 6 Day 1 infusion in CLL patients, the estimated median Cmax value was 465.7 μg/mL and AUC(τ) value was 8961 μg•d/mL and in iNHL patients the estimated median Cmax value was
Croatian: Populacijski farmakokinetički model pokazao je da je nakon infuzije koju su bolesnici s KLL-om primili 1. dan 6. ciklusa procijenjeni medijan vrijednosti Cmax iznosio 465,7 μg/ml, a AUC(τ) 8961 μg•d/ml, dok je u bolesnika s iNHL-om procijenjeni medijan vrijednosti
English: Premedication for subsequent infusions and other premedication should be administered as described below.
Croatian: Premedikaciju prije sljedećih infuzija i ostalu premedikaciju treba primjenjivati na način opisan u nastavku.
English: No. (%) of patients with event Median time to event (months)
Croatian: Broj (%) bolesnika s događajem Medijan vremena do događaja (mjeseci)
English: What Gazyvaro is and what it is used for
Croatian: Što je Gazyvaro i za što se koristi
English: · medicine to prevent tumour lysis syndrome (such as allopurinol).
Croatian: · lijekove koji sprječavaju sindrom lize tumora (poput alopurinola)
English: Less frequently reported: · irregular heartbeat · swelling of the throat or airway · wheezing, difficulty breathing, tight chest or throat irritation
Croatian: Manje često prijavljene: · nepravilni otkucaji srca · oticanje grla ili dišnih putova · piskanje, otežano disanje, stezanje u prsnom košu ili nadraženost grla
English: The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered on Day 1 of each cycle.
Croatian: Preporučena doza lijeka Gazyvaro u kombinaciji s klorambucilom iznosi 1000 mg, a primjenjuje se 1. dan svakog ciklusa.
English: 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.
Croatian: Nalazi su uključivali akutne anafilaktičke ili anafilaktoidne reakcije te povećanu prevalenciju sistemske upale i infiltrata, što odgovara reakcijama preosjetljivosti posredovanima imunološkim kompleksima, poput arteritisa/periarteritisa, glomerulonefritisa te upale seroznih ovojnica/adventicije.
English: These trials investigated Gazyvaro in combination with chlorambucil for CLL and with bendamustine, CHOP or CVP followed by Gazyvaro maintenance therapy for iNHL.
Croatian: Ta su ispitivanja ocjenjivala Gazyvaro u kombinaciji s klorambucilom za KLL te u kombinaciji s bendamustinom, protokolom CHOP ili protokolom CVP, nakon čega je slijedila terapija održavanja lijekom Gazyvaro, za iNHL.
English: It should be given as an intravenous infusion through a dedicated line after dilution (see section 6.6).
Croatian: Nakon razrjeđivanja primjenjuje se intravenskom infuzijom kroz poseban venski put (vidjeti dio 6.6).
English: If you had any of these symptoms before treatment with Gazyvaro, tell your doctor straight away if you notice any changes in them.
Croatian: Ako ste bilo koji od tih simptoma imali i prije liječenja lijekom Gazyvaro, odmah obavijestite svog liječnika ako primijetite da su se oni promijenili.
English: Gazyvaro was given by intravenous infusion as a dose of 1,000 mg on Days 1, 8 and 15 of Cycle 1, on Day 1 of Cycles 2-6, and in patients who did not have disease progression, once every two months for two years or until disease progression (whichever occurs first).
Croatian: Gazyvaro se primjenjivao intravenskom infuzijom u dozi od 1000 mg 1., 8. i 15. dan 1. ciklusa, 1. dan 2. - 6. ciklusa, te u bolesnika bez progresije bolesti jedanput svaka dva mjeseca tijekom dvije godine ili do progresije bolesti (što god je nastupilo ranije).
English: 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.
Croatian: Da biste pripremili 2 infuzijske vrećice, izvucite 40 ml koncentrata iz bočice i razrijedite 4 ml u 100-mililitarskoj infuzijskoj vrećici od PVC-a ili poliolefina koja ne sadrži PVC, a preostalih 36 ml dodajte u 250-mililitarsku infuzijsku vrećicu od PVC-a ili poliolefina koja ne sadrži PVC, u kojima se nalazi otopina za injekciju 9 mg/ml (0,9%) natrijevog klorida.
English: Day of treatment
Croatian: Dan liječenja
English: 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.
Croatian: Nakon 6. - 8. ciklusa u kombinaciji s kemoterapijom, bolesnici koji su odgovorili na liječenje primali su terapiju održavanja lijekom Gazyvaro svaka 2 mjeseca do progresije bolesti ili tijekom najviše 2 godine.
English: 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).
Croatian: 20. dana nakon parenja do okota dovela je do potpune deplecije B stanica u mladunčadi majmuna kada je obinutuzumab primjenjivan u tjednim intravenskim dozama od 25 i 50 mg/kg (izloženost 2-5 puta veća od kliničke izloženosti na temelju Cmax i AUC-a).