natgillin/translations-raw huggingface dataset:
Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRs in patients with CLL and FL (see section 4.4) 
Tablica 1 Premedikacija koju je potrebno primijeniti prije infuzije lijeka Gazyvaro radi smanjenja rizika od reakcija na infuziju u bolesnika s KLL-om i FL-om (vidjeti dio 4.4)
The population pharmacokinetic analysis of obinutuzumab showed that creatinine clearance does not affect pharmacokinetics of obinutuzumab. 
Oštećenje funkcije bubrega Populacijska farmakokinetička analiza obinutuzumaba pokazala je da klirens kreatinina ne utječe na farmakokinetiku obinutuzumaba.
Chlorambucil was given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles (1 to 6). 
Klorambucil je primjenjivan peroralno u dozi od 0,5 mg/kg tjelesne težine 1. dan i 15. dan u svakom ciklusu liječenja (1.-6. ciklusa).
Injury, poisoning and procedural complications Very common 
Ozljede, trovanja i proceduralne komplikacije vrlo često reakcije na infuziju reakcije na infuziju
No incompatibilities have been observed between Gazyvaro, in concentration ranges from 0.4 mg/mL to 20.0 mg/mL after dilution of Gazyvaro with sodium chloride 9 mg/mL (0.9%) solution for injection, and: · PVC, polyethylene (PE), polypropylene or polyolefin bags · PVC, polyurethane (PUR) or PE infusion sets · optional inline filters with product contact surfaces of polyethersulfone (PES), a 3-way stopcock infusion aid made from polycarbonate (PC), and catheters made from polyetherurethane (PEU). 
Nisu primijećene inkompatibilnosti između lijeka Gazyvaro u koncentracijama u rasponu od 0,4 mg/ml do 20,0 mg/ml nakon razrjeđivanja otopinom za injekciju 9 mg/ml (0,9%) natrijevog klorida i: · vrećica načinjenih od PVC-a, polietilena (PE), polipropilena ili poliolefina · infuzijskih setova načinjenih od PVC-a, poliuretana (PUR) ili polietilena (PE)
No Grade 5 events of thrombocytopenia were reported. 
Nisu zabilježeni slučajevi trombocitopenije 5. stupnja.
· infection of upper airways (infection of nose, pharynx, larynx and sinuses), cough 
· infekcija gornjih dišnih putova (infekcija nosa, ždrijela, grkljana i sinusa), kašalj
Atrial fibrillation, cardiac failure Atrial fibrillation, cardiac failure, 
Srčani poremećaji često fibrilacija atrija, zatajenje srca fibrilacija atrija, zatajenje srca
Gazyvaro + chlorambucil N= 238 
Gazyvaro + klorambucil N=238
The incidence of neutropenia was higher in the Gazyvaro plus chlorambucil arm (41%) compared to the rituximab plus chlorambucil arm with the neutropenia resolving spontaneously or with use of granulocyte-colony stimulating factors. 
Incidencija neutropenije bila je veća u skupini liječenoj lijekom Gazyvaro i klorambucilom (41%) nego u skupini liječenoj rituksimabom i klorambucilom, a povukla se spontano ili uz primjenu čimbenika poticanja rasta kolonija granulocita.
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 subsequent cycles. 
Gazyvaro se primjenjivao intravenskom infuzijom u dozi od 1000 mg 1., 8. i 15. dan 1. ciklusa te 1. dan ostalih ciklusa.
Tell your doctor or nurse if you notice any of the side effects listed above. 
Obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od navedenih nuspojava.
No studies have been conducted to investigate the pharmacokinetics of obinutuzumab in paediatric patients. 
Nisu provedena ispitivanja kojima bi se ocijenila farmakokinetika obinutuzumaba u pedijatrijskih bolesnika.
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). 
28 dana nakon okota, dok su koncentracije u mlijeku istoga dana bile vrlo niske, što pokazuje da obinutuzumab prolazi kroz posteljicu (vidjeti dio 5.3).
Chronic Lymphocytic Leukaemia 
Kronična limfocitna leukemija
Intravenous corticosteroid1,4 (mandatory for CLL, recommended for FL) 
Intravenski kortikosteroid1,4 (obavezno kod KLL-a,
Only the highest frequency observed in the trials is reported (based on studies BO21004/previously untreated CLL, BO21223/previously untreated advanced iNHL and GAO4753g/rituximab refractory iNHL) 
Prijavljena je samo najveća učestalost primijećena u ispitivanjima (na temelju ispitivanja BO21004/prethodno neliječen KLL, BO21223/prethodno neliječen uznapredovao iNHL
2 e.g. 1,000 mg acetaminophen/paracetamol 
2 npr. 1000 mg acetaminofena/paracetamola npr. 50 mg difenhidramina
Median observation time 34 months 
Medijan vremena promatranja: 34 mjeseca
Chronic lymphocytic leukaemia (in combination with chlorambucil1) 
Kronična limfocitna leukemija (u kombinaciji s klorambucilom1)
Thirty-four percent of patients were enrolled on comorbidity score alone, and 23% of patients were enrolled with only impaired renal function. 
Trideset i četiri posto bolesnika uključeno je u ispitivanje samo na temelju rezultata bodovanja za komorbiditeta, a 23%
Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Gazyvaro infusion and for the first hour after administration (see section 4.4). 
Stoga, potrebno je razmotriti suzdržavanje od antihipertenzivnog liječenja 12 sati prije i tijekom svake infuzije lijeka Gazyvaro te još sat vremena nakon primjene lijeka (vidjeti dio 4.4).
22.8 months median observation time g 
medijan vremena promatranja: 22,8 mjeseci g medijan vremena promatranja: 18,7 mjeseci g
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 
1000 mg Bendamustin se primjenjuje intravenski 1. i 2. dan u svim ciklusima liječenja (1. - 6. ciklus) u dozi od 90 mg/m2/dan; protokoli CHOP i CVP primjenjuju se prema standardnom režimu.
The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered over Day 1 and Day 2 (or Day 1 continued), and on Day 8 and Day 15 of the first 28 day treatment cycle. 
Preporučena doza lijeka Gazyvaro u kombinaciji s klorambucilom je 1000 mg, a primjenjuje se tijekom 1. i 2. dana (ili u nastavku 1. dana) te 8. dan i 15. dan prvog ciklusa liječenja u trajanju od 28 dana.
For management of IRRs see section 4.2 Posology and method of administration. 
Za zbrinjavanje reakcija na infuziju vidjeti dio 4.2 'Doziranje i način primjene'.
Patients with a CrCl < 40 mL/min were excluded from the studies (see section 5.1). 
Bolesnici koji su imali CrCl < 40 ml/min nisu bili uključeni u ispitivanja (vidjeti dio 5.1).
Cases of hepatitis B reactivation have been reported in patients treated with Gazyvaro (see section 4.4). 
U bolesnika liječenih lijekom Gazyvaro prijavljeni su slučajevi reaktivacije hepatitisa B (vidjeti dio 4.4).
White blood cell count decreased, neutrophil count decreased, weight increased 
smanjen broj neutrofila, povećanje tjelesne težine smanjen broj bijelih krvnih stanica, smanjen broj neutrofila
Rituximab + Chemotherapy followed by rituximab maintenance N=601 
Rituksimab + kemoterapija, nakon čega slijedi terapija održavanja rituksimabom N=601
These reactions led to unscheduled termination of 6/36 animals treated with obinutuzumab during dosing and recovery phases; these changes were partially reversible. 
Te su reakcije tijekom razdoblja doziranja i oporavka dovele do neplaniranog usmrćivanja 6/36 životinja kojima je primjenjivan obinutuzumab;
Median observation time 35 months 
Medijan vremena promatranja: 35 mjeseci
Tell your doctor or nurse straight away if you get any signs of infection during and after your Gazyvaro treatment. 
Obavijestite svog liječnika ili medicinsku sestru ako tijekom ili nakon liječenja lijekom Gazyvaro dobijete bilo koji simptom infekcije.
Patients with a CrCl < 30 mL/min were excluded from the study (see section 5.1). 
Bolesnici koji su imali CrCl < 30 ml/min nisu bili uključeni u ispitivanje (vidjeti dio 5.1).
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). 
Uvodno liječenje u trajanju od približno šest mjeseci (šest ciklusa liječenja lijekom Gazyvaro, od kojih svaki traje 28 dana, kada se primjenjuje u kombinaciji s bendamustinom, ili osam ciklusa liječenja lijekom Gazyvaro, od kojih svaki traje 21 dan, kada se primjenjuje u kombinaciji s protokolom CHOP ili CVP), nakon čega slijedi terapija održavanja jedanput svaka 2 mjeseca tijekom 2 godine ili do progresije bolesti (što god nastupi ranije).
Gazyvaro + chlorambucil N= 333 
Gazyvaro + klorambucil N=333
Cycles 2-6 or 2-8 
2. - 6. ciklus ili 2. - 8. ciklus
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). 
U ključnom ispitivanju BO21004/CLL11, 27% (90 od 336) bolesnika liječenih lijekom Gazyvaro i klorambucilom imalo je umjereno oštećenje funkcije bubrega (CrCl < 50 ml/min).
1 Chlorambucil is given orally at 0.5 mg/kg body weight on Day 1 and Day 15 of all treatment cycles 
1000 mg 1Klorambucil se primjenjuje peroralno u dozi od 0,5 mg/kg tjelesne težine 1. dan i 15. dan u svim ciklusima liječenja
Beyond Cycle 1 the incidence of IRRs in subsequent infusions was comparable between the Gazyvaro and the relevant comparator arms. 
incidencija reakcija na infuziju kod sljedećih infuzija bila je usporediva između skupine koja je primala Gazyvaro i relevantne usporedne skupine.
Day 1 (100 mg) 
1. dan (100 mg)
Rituximab + chlorambucil N= 330 
rituksimab + klorambucil N=330
What Gazyvaro is used for 
Za što se Gazyvaro koristi
No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3). 
U ispitivanjima toksičnosti ponovljenih doza na makaki majmunima nisu primijećeni štetni učinci na reproduktivne organe mužjaka ni ženki (vidjeti dio 5.3).
IRRs may be clinically indistinguishable from immunoglobulin E (IgE) mediated allergic reactions (e.g. anaphylaxis). 
Reakcije na infuziju klinički mogu biti istovjetne alergijskim reakcijama posredovanim imunoglobulinom E (IgE) (npr. anafilaksiji).
Transient elevation in liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase) has been observed shortly after the first infusion of Gazyvaro. 
Ubrzo nakon prve infuzije lijeka Gazyvaro primijećeno je prolazno povišenje vrijednosti jetrenih enzima (aspartat aminotransferaze [AST], alanin aminotransferaze [ALT] i alkalne fosfataze).
Recovery of B-cells was observed within 12-18 months of follow up in 35% (14 out of 40) of patients without progressive disease and 13% (5 out of 40) with progressive disease. 
(14 od 40) bolesnika čija bolest nije bila progresivna te u 13% (5 od 40) bolesnika s progresivnom bolešću.
Overall, 7% of patients experienced an IRR leading to discontinuation of Gazyvaro. 
Ukupno je 7% bolesnika imalo reakciju na infuziju koja je dovela do trajnog prekida liječenja lijekom Gazyvaro.
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 (study GAO4753g/GADOLIN). 
Bolesnici s folikularnim limfomom koji nisu odgovorili na liječenje rituksimabom ili protokolom koji sadrži rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja (ispitivanje GAO4753g/GADOLIN).
Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Gazyvaro infusion and for the first hour after administration. 
Stoga, potrebno je razmotriti suzdržavanje od antihipertenzivnog liječenja 12 sati prije i tijekom svake infuzije lijeka Gazyvaro te još sat vremena nakon primjene lijeka.
respectively at Cycle 6 and AUC and Cmax in iNHL of 13172 µg•d/mL and 635.7 µg/mL in females and 9769 µg•d/mL and 481.3 µg/mL in males, respectively), indicating that there is no need to dose adjust based on gender. 
6. ciklusu liječenja bolesnika s KLL-om iznosio je 11 282 µg•d/ml odnosno 578,9 µg/ml u žena te 8451 µg•d/ml odnosno 432,5 µg/ml u muškaraca, dok su AUC odnosno Cmax u bolesnika s iNHL-om iznosili 13 172 µg•d/ml odnosno 635,7 µg/ml u žena te 9769 µg•d/ml odnosno 481,3 µg/ml u muškaraca), što znači da nema potrebe za prilagođavanjem doze na temelju spola.
Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype. 
Obinutuzumab je humanizirano i glikoinženjeringom modificirano rekombinantno monoklonsko anti-CD20 protutijelo tipa II, koje pripada podskupini IgG1.
A population pharmacokinetic (PK) model was developed to analyse the PK data in 469 iNHL, 342 CLL and 130 diffuse large B-cell lymphoma (DLBCL) patients from Phase I, Phase II and Phase III studies who received obinutuzumab alone or in combination with chemotherapy. 
469 bolesnika s iNHL-om, 342 bolesnika s KLL-om i 130 bolesnika s difuznim B-velikostaničnim limfomom (engl. diffuse large B-cell lymphoma, DLBCL) koji su u ispitivanjima faze I, faze II i faze III primali obinutuzumab samostalno ili u kombinaciji s kemoterapijom.
Patients with a high tumour burden and/or high circulating lymphocyte count in CLL [> 25 x 109/L] may be at increased risk of severe IRRs. 
Bolesnici s KLL-om koji imaju veliko tumorsko opterećenje i/ili velik broj limfocita u cirkulaciji (> 25 x 109/l) mogu imati povećan rizik od teških reakcija na infuziju.
No Grade 3-5 IRRs were reported beyond the first 1,000 mg infusions of Cycle 1. 
Nakon infuzije prvih 1000 mg u 1. ciklusu nije prijavljena više niti jedna reakcija na infuziju 3.-5. stupnja.
· Use an effective method of contraception while being treated with Gazyvaro. 
Zaštita od trudnoće · Koristite učinkovitu metodu sprječavanja trudnoće dok se liječite lijekom Gazyvaro.
The incidence of IRRs with subsequent infusions was 3% with the second 1,000 mg dose and 1% thereafter. 
tijekom druge doze od 1000 mg te 1% nakon toga.
Difference in MRD rates, (95% CI) Event free survival 
Razlika u stopama MRD-a (95% CI)
Gazyvaro infusions should not be administered as an intravenous push or bolus. 
Gazyvaro se ne smije primijeniti brzom niti bolusnom intravenskom injekcijom.
Patients who experience neutropenia should be closely monitored with regular laboratory tests until resolution. 
Bolesnike u kojih se pojavi neutropenija potrebno je pažljivo pratiti redovitim laboratorijskim pretragama sve do normalizacije krvne slike.
An enhanced pre and postnatal development (ePPND) toxicity study in pregnant cynomolgus monkeys showed no evidence of teratogenic effects. 
Prošireno istraživanje toksičnih učinaka na prenatalni i postnatalni razvoj u skotnih ženki makaki majmuna nije ukazalo na teratogene učinke.
HBVscreening should be performed in all patients before initiation of treatment with Gazyvaro. 
Prije početka liječenja lijekom Gazyvaro u svih bolesnika je potrebno napraviti probir na HBV.
Table 1 Premedication to be administered before Gazyvaro infusion to reduce the risk of IRRsin CLL and FL patients 
Tablica 1 Premedikacija koju je potrebno primijeniti prije infuzije lijeka Gazyvaro radi smanjenja rizika od reakcija na infuziju u bolesnika s KLL-om i FL-om
Gazyvaro +Chemotherapy followed by Gazyvaro maintenance N=601 
Gazyvaro + kemoterapija, nakon čega slijedi terapija održavanja lijekom Gazyvaro N=601
Table 7 Summary of efficacy from BO21004/CLL11 study Stage 1a 
Tablica 7 Sažetak rezultata za djelotvornost iz ispitivanja BO21004/CLL11
Efficacy results for patients with previously untreated CLL are summarised in Table 7. 
Rezultati za djelotvornost u bolesnika s prethodno neliječenom kroničnom limfocitnom leukemijom sažeto su prikazani u Tablici 7.
Patients were stratified according to region, iNHL subtype (follicular versus non-follicular), rituximab-refractory type (whether refractory to prior rituximab monotherapy or rituximab in combination with chemotherapy) 
Bolesnici su bili stratificirani prema regiji, podtipu iNHL-a (folikularni ili nefolikularni), tipu refraktornosti na rituksimab (je li bolest bila refraktorna na prethodno liječenje rituksimabom u monoterapiji ili u kombinaciji s kemoterapijom) te broju prethodnih terapija (≤ 2 naspram > 2).
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. 
dok su istoga dana koncentracije u mlijeku bile jako niske (manje od 0,5% odgovarajućih razina u serumu majke), što ukazuje na to da je do izloženosti mladunčadi moralo doći in utero.
A therapy choice for these patients should carefully consider the overall safety profile of Gazyvaro plus chemotherapy and the patient-specific situation. 
Kod izbora terapije za ove bolesnike treba pažljivo razmotriti ukupni sigurnosni profil lijeka
No formal drug-drug interaction studies have been performed, although limited drug-drug interaction sub-studies have been undertaken for Gazyvaro with bendamustine, CHOP, fludarabine and cyclophosphamide (FC), and chlorambucil. 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena formalna ispitivanja interakcija s drugim lijekovima, ali su provedena ograničena podispitivanja interakcija lijeka Gazyvaro s bendamustinom, protokolom CHOP, fludarabinom i ciklofosfamidom (protokol FC) te klorambucilom.
Thrombocytopenia occurred more frequently in Cycle 1 in the Gazyvaro plus chemotherapy arm. Thrombocytopenia occurring during or 24 hours from end of infusion (acute thrombocytopenia) was more frequently observed in patients in the Gazyvaro plus chemotherapy arm than in the comparator arm. 
Trombocitopenija koja je nastupila tijekom infuzije ili unutar 24 sata od njezina završetka (akutna trombocitopenija) češće je primijećena u bolesnika u skupini liječenoj lijekom Gazyvaro plus kemoterapijom nego u usporednoj skupini.
Cycles 2 - 6 
2.-6. ciklus
For management of symptomatic adverse events (including IRRs), see paragraph below (Management of IRRs or section 4.4). 
Za zbrinjavanje simptomatskih nuspojava (uključujući reakcije na infuziju), vidjeti odlomak u nastavku ('Zbrinjavanje reakcija na infuziju' ili dio 4.4).
Therapy with Gazyvaro should be withheld during the investigation of potential PML and permanently discontinued in case of confirmed PML. 
Suzdržavanje od terapije lijekom Gazyvaro potrebno je dok se ne utvrdi boluje li bolesnik od PML-a, a ako se PML potvrdi, liječenje je potrebno trajno obustaviti.
Stage 1a compared Gazyvaro plus chlorambucil to chlorambucil alone in 356 patients and Stage 2 compared Gazyvaro plus chlorambucil to rituximab plus chlorambucil in 663 patients. 
U stadiju 1a uspoređivana je kombinacija lijeka Gazyvaro i klorambucila s monoterapijom klorambucilom u 356 bolesnika, dok je u 2. stadiju
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. 
utvrđeno je da su bolesnici u obje liječene skupine doživjeli klinički značajno poboljšanje simptoma povezanih s limfomom, koje se definiralo kao povećanje početnog rezultata na podljestvici za ocjenu limfoma za ≥ 3 boda, povećanje početnog rezultata indeksa ishoda ispitivanja (engl.
When these symptoms go away, or improve, the infusion can be continued. 
Infuzija se može nastaviti nakon povlačenja ili poboljšanja simptoma.
The median estimated CrCl was 62 mL/min and 66% of all patients had a CrCl < 70 mL/min. 
a 66% svih bolesnika imalo je CrCl < 70 ml/min.
Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or suitable alternative treatment such as urate oxidase (e.g. rasburicase), starting 12-24 hours prior to start of Gazyvaro infusion as per standard practice (see section 4.4). 
Profilaksa bi se trebala sastojati od odgovarajuće hidracije i primjene urikostatika (npr. alopurinola) ili neke druge prikladne terapije, poput urat oksidaze (npr. razburikaze), započevši 12 - 24 sata prije početka infuzije lijeka Gazyvaro u skladu s uobičajenom praksom (vidjeti dio 4.4).
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 or 120 mg/m2/day when given alone. 
Bendamustin se primjenjivao intravenski 1. i 2. dan u svim ciklusima liječenja (1. - 6. ciklus), u dozi od 90 mg/m2/dan kada se primjenjivao u kombinaciji s lijekom Gazyvaro ili u dozi od 120 mg/m2/dan kada se primjenjivao samostalno.
The adverse drug reactions (ADRs) described in this section were identified during induction, maintenance and follow up for indolent Non-Hodgkin lymphoma (iNHL) including FL; treatment and follow up for CLL in the three pivotal clinical studies: · BO21004/CLL11 (N=781): Patients with previously untreated CLL · BO21223/GALLIUM (N=1390): Patients with previously untreated iNHL (86% of the patients had FL) · GAO4753g/GADOLIN (N=392): Patients with iNHL (81% of the patients had FL) who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. 
· BO21004/CLL11 (N = 781): bolesnici s prethodno neliječenim KLL-om · BO21223/GALLIUM (N=1390): bolesnici s prethodno neliječenim iNHL-om (86% bolesnika imalo je FL) · GAO4753g/GADOLIN (N = 392): bolesnici s iNHL-om (81% bolesnika imalo je FL) koji nisu odgovorili na prethodno liječenje rituksimabom ili protokolom koji je sadržavao rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja.
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. 
Bendamustin se primjenjivao intravenski 1. i 2. dan u svim ciklusima liječenja (1. - 6. ciklus) u dozi od 90 mg/m2/dan kada se primjenjivao u kombinaciji s lijekom Gazyvaro.
Prophylaxis and premedication for tumour lysis syndrome (TLS) 
Profilaksa i premedikacija za sindrom lize tumora
Additional safety information from clinical studies experience 
Dodatne informacije o sigurnosti iz kliničkih ispitivanja Progresivna multifokalna leukoencefalopatija
If you miss a Gazyvaro treatment 
Ako propustite primiti Gazyvaro
A clear relationship between thrombocytopenia and haemorrhagic events has not been established. 
Nije ustanovljena jasna veza između trombocitopenije i događaja krvarenja.
Patients in the CLL pivotal study BO21004/CLL11 were tested at multiple time-points for anti-therapeutic antibodies (ATA) to Gazyvaro. 
U ključnom ispitivanju BO21004/CLL11 bolesnici s KLL-om testirani su u više navrata kako bi se utvrdila prisutnost protutijela na lijek Gazyvaro.
Before each infusion of Gazyvaro, you will be given medicines to lessen the chance of getting infusion related reactions or tumour lysis syndrome. 
Lijekovi koje ćete primiti prije svake infuzije Prije svake infuzije lijeka Gazyvaro primit ćete lijekove koji će smanjiti vjerojatnost razvoja s infuzijom povezane reakcije ili sindroma lize tumora.
The Gazyvaro treatment 
Liječenje lijekom Gazyvaro
Mitigation measures to reduce IRRs should be followed (see section 4.2). 
Potrebno je primjenjivati navedene mjere kako bi se smanjio broj reakcija na infuziju (vidjeti dio 4.2).
How Gazyvaro works 
Kako Gazyvaro djeluje
Respiratory, thoracic and mediastinal disorders Very common 
Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često kašalj§