natgillin/translations-raw huggingface dataset:
Patients with a high tumour burden and/or a high circulating lymphocyte count (> 25 x 109/L) and/or renal impairment (CrCl < 70 mL/min) are considered at risk of TLS and should receive prophylaxis. 
Bolesnici s velikim tumorskim opterećenjem i/ili velikim brojem cirkulirajućih limfocita (> 25 x 109/l) i/ili oštećenjem bubrežne funkcije (CrCl <70 ml/min) smatraju se rizičnima za razvoj sindroma lize tumora i stoga bi trebali primiti profilaksu.
· Tell your doctor or nurse straight away if you get any of the infusion related reactions listed at the start of section 4. 
· Odmah obavijestite liječnika ili medicinsku sestru ako primijetite bilo koju od reakcija na infuziju navedenih na početku dijela 4. Reakcije na infuziju mogu se javiti tijekom infuzije ili do 24 sata nakon infuzije.
Induction (in combination with bendamustine2) Gazyvaro should be administered in six 28-day cycles in combination with bendamustine2. 
Gazyvaro treba primjenjivati tijekom šest 28-dnevnih ciklusa u kombinaciji s bendamustinom2.
In patients with underlying cardiac disease, arrhythmias (such as atrial fibrillation and tachyarrhythmia), angina pectoris, acute coronary syndrome, myocardial infarction and heart failure have occurred when treated with Gazyvaro (see section 4.8). 
(poput fibrilacije atrija i tahiaritmije), angina pektoris, akutni koronarni sindrom, infarkt miokarda te zatajenje srca (vidjeti dio 4.8).
Rate of infusion 
Brzina infuzije
HR (95% CI) p-value (Log-Rank test, stratified*) 
HR (95% CI) p-vrijednost (log-rang test, stratificiran*)
Day 8 (1,000 mg) 
8. dan (1000 mg)
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of Gazyvaro as outlined below. 
Zbrinjavanje reakcija na infuziju (sve indikacije) Zbrinjavanje reakcija na infuziju može zahtijevati privremeni prekid primjene, smanjenje brzine infuzije ili obustavu liječenja lijekom Gazyvaro kako je navedeno u nastavku.
Hypotension may occur during Gazyvaro intravenous infusions. 
Tijekom intravenskih infuzija lijeka Gazyvaro može se pojaviti hipotenzija.
For patients with FL, the recommended dose of Gazyvaro in combination with chemotherapy is shown in Table 3. 
Preporučena doza lijeka Gazyvaro u kombinaciji s kemoterapijom za bolesnike s FL-om prikazana je u Tablici 3.
Administer at 50 mg/hr. 
50 mg/h.
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 infuziju koja se primjenjuje 1. i 2. dan potrebno je pripremiti dvije infuzijske vrećice (100 mg za
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 
Nakon razrjeđivanja, dokazane su kemijska i fizička stabilnost u otopini za injekciju 9 mg/ml (0,9%)
In the Gazyvaro plus chemotherapy arm, the incidence of Grade 1-4 neutropenia (50%) was higher relative to the comparator arm with an increased risk during the induction period. 
Incidencija neutropenije 1. - 4. stupnja bila je veća u skupini liječenoj lijekom Gazyvaro plus kemoterapijom (50%) nego u usporednoj skupini, uz povećan rizik tijekom razdoblja uvodnog liječenja.
The metabolism of obinutuzumab has not been directly studied. 
Nisu provedena izravna ispitivanja metabolizma obinutuzumaba.
Prophylaxis should consist of adequate hydration and administration of uricostatics (e.g. allopurinol), or a suitable alternative such as a urate oxidate (e.g. rasburicase) starting 12-24 hours prior to the infusion of Gazyvaro as per standard practice (see section 4.2). 
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 infuzije lijeka Gazyvaro u skladu s uobičajenom praksom (vidjeti dio 4.2).
Upper respiratory tract infection, sinusitis§, , urinary tract infection, pneumonia§ ,herpes zoster§ 
§, infekcija mokraćnih putova, pneumonija§, herpes zoster§
For patients with CLL the recommended dose of Gazyvaro in combination with chlorambucil is shown in Table 2. 
Preporučena doza lijeka Gazyvaro u kombinaciji s klorambucilom za bolesnike s KLL-om prikazana je u Tablici 2.
Package leaflet: Information for the patient Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab 
Uputa o lijeku: Informacije za bolesnika Gazyvaro 1000 mg koncentrat za otopinu za infuziju obinutuzumab
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. 
bolesnika s KLL-om u kojih je na način opisan u dijelu 4.2. primijenjena kombinacija mjera za sprječavanje reakcija na infuziju (odgovarajući kortikosteroid, oralni analgetik/antihistaminik, izostavljanje antihipertenziva ujutro na dan prve infuzije i primjena 1. doze 1. ciklusa tijekom 2 dana)
In a phase III, open label, multicentre, randomised clinical study (GAO4753g/GADOLIN), 396 patients with iNHL who had no response during treatment or who progressed within 6 months following the last dose of rituximab or a rituximab-containing regimen (including rituximab monotherapy as part of induction or maintenance treatment) were evaluated. 
(GAO4753g/GADOLIN) ocijenjeno je 396 bolesnika s iNHL-om koji nisu odgovorili na liječenje ili su doživjeli progresiju unutar 6 mjeseci nakon posljednje doze rituksimaba ili protokola koji je sadržavao rituksimab (uključujući monoterapiju rituksimabom u sklopu uvodnog liječenja ili terapije održavanja).
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. 
Naime, u muškaraca je klirens u stanju dinamičke ravnoteže (CLss) bio 22% veći, a volumen distribucije 19% veći nego u žena.
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%). 
Tijekom razdoblja terapije održavanja u ispitivanju GAO4753g/GADOLIN, najčešće nuspojave bile su kašalj (15%), infekcije gornjih dišnih putova (12%), neutropenija (11%), sinusitis (10%), proljev
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of Gazyvaro as outlined below (see also section 4.4). 
Zbrinjavanje reakcija na infuziju (sve indikacije) Zbrinjavanje reakcija na infuziju može zahtijevati privremeni prekid primjene, smanjenje brzine infuzije ili obustavu liječenja lijekom Gazyvaro kako je navedeno u nastavku (vidjeti i dio 4.4).
If no IRR occurred during the previous infusion, when the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. 
Ako se tijekom prethodne infuzije, kada je konačna brzina infuzije bila 100 mg/h ili viša, nije razvila reakcija na infuziju, infuzije je moguće započeti brzinom od 100 mg/h, a zatim povećavati za 100 mg/h svakih 30 minuta do maksimalno 400 mg/h.
It should be given as an intravenous infusion through a dedicated line after dilution. 
Nakon razrjeđivanja primjenjuje se intravenskom infuzijom kroz poseban venski put.
Figure 8 IRC-assessed PFS by patient subgroup in FL *# (Study GAO4753g/GADOLIN) 
Slika 8 PFS po podskupinama bolesnika s FL-om prema ocjeni neovisnog ocjenjivačkog povjerenstva*# (ispitivanje GAO4753g/GADOLIN)
Patient-reported Outcomes 
Trial Outcome
How to store Gazyvaro 
Kako primjenjivati Gazyvaro
NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion. 
NAZIV LIJEKA Gazyvaro 1000 mg koncentrat za otopinu za infuziju.
Patients in the G+B arm who did not have disease progression (i.e. patients with a complete response (CR), partial response (PR) or stable disease (SD)) at the end of induction continued receiving Gazyvaro maintenance once every two months for two years or until disease progression (whichever occurred first). 
Bolesnici u skupini liječenoj kombinacijom G+B koji nisu doživjeli progresiju bolesti (tj. bolesnici s potpunim odgovorom [CR], djelomičnim odgovorom [PR] ili stabilnom bolešću [engl. stable disease, SD]) na kraju razdoblja uvodnog liječenja, nastavili su primati
PML is a very rare and life-threatening brain infection that has been reported with Gazyvaro. 
Progresivna multifokalna leukoencefalopatija PML je vrlo rijetka i po život opasna infekcija mozga prijavljena kod primjene lijeka Gazyvaro.
Day 15 (1,000 mg) 
15. dan (1000 mg)
Co-administration with Gazyvaro had no effect on the pharmacokinetics of bendamustine, FC, chlorambucil or the individual components of CHOP. 
Istodobna primjena s lijekom Gazyvaro nije utjecala na farmakokinetiku bendamustina, protokola FC,
Figure 7 Kaplan-Meier curve of OS in patients with FL # (Study GAO4753g/GADOLIN) 
Slika 7 Kaplan-Meierova krivulja OS-a u bolesnika s FL-om# (ispitivanje GAO4753g/GADOLIN)
HistidineHistidine hydrochloride monohydrate Trehalose dihydrate 
histidin histidinklorid hidrat trehaloza dihidrat poloksamer 188 voda za injekcije
Severe and life-threatening neutropenia including febrile neutropenia has been reported during treatment with Gazyvaro. 
Tijekom liječenja lijekom Gazyvaro prijavljena je teška i po život opasna neutropenija, uključujući febrilnu neutropeniju.
IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, MRD: Minimal Residual Disease, NR = Not reached a Defined as the time from randomisation to the first occurrence of progression, relapse or death from any cause as assessed by the investigator b stratified by Binet stage at baseline c Includes 11 patients in the GClb arm with a complete response with incomplete marrow recovery d Blood and bone marrow combined e MRD negativity is defined as a result below 0.0001 f Includes MRD positive patients and patients who progressed or died before the end of treatment g Median observation time for overall survival (OS) data corresponds to 62.5 months median observation time in Stage 1a and to 59.4 months median observation time in Stage 2. 
PFS (engl. progression-free survival): preživljenje bez progresije bolesti; HR (engl. hazard ratio): omjer hazarda; CI (engl. confidence intervals): intervali pouzdanosti; MRD (engl. minimal residual disease): minimalna ostatna bolest, ND = nije dostignuto a Definira se kao vrijeme od randomizacije do prvog nastupa progresije, relapsa ili smrti zbog bilo kojeg uzroka prema ocjeni ispitivača b Stratificirano prema stadiju bolesti po Binetovoj klasifikaciji na početku ispitivanja c
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. 
ALT > 5 x GGN tijekom > 2 tjedna; bilirubin > 3 x GGN] i funkcijom bubrega (CrCl < 30 ml/min) nisu bili uključeni u ispitivanje.
Induction (in combination with chemotherapy2) Gazyvaro should be administered with chemotherapy as follows: 
Gazyvaro treba primjenjivati s kemoterapijom na sljedeći način:
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. 
Najčešće primijećene nuspojave u bolesnika liječenih lijekom Gazyvaro bile su reakcije na infuziju, a javljale su se prvenstveno tijekom infuzije prvih 1000 mg.
Dose of Gazyvaro 
Doza lijeka Gazyvaro
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Gazyvaro 1000 mg koncentrat za otopinu za infuziju obinutuzumab
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. 
U ispitivanju GAO4753g/GADOLIN, bolesnici u skupini liječenoj bendamustinom primili su samo
One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL 
Jedna bočica s 40 ml koncentrata sadrži 1000 mg obinutuzumaba, što odgovara koncentraciji od
Withdraw 40 mL of concentrate from the vial and dilute in polyvinyl chloride (PVC) or non-PVC polyolefin infusion bags containing sodium chloride 9 mg/mL (0.9%) solution for injection. 
ili od poliolefina koje ne sadrže PVC, u kojima se nalazi otopina za injekcije 9 mg/ml (0,9%) natrijevog klorida.
Severe and life-threatening thrombocytopenia including acute thrombocytopenia (occurring within 24 hours after the infusion) has been observed during treatment with Gazyvaro. 
Tijekom liječenja lijekom Gazyvaro primijećena je teška i po život opasna trombocitopenija, uključujući akutnu trombocitopeniju (koja se javlja unutar 24 sata nakon infuzije).
Cases of prolonged neutropenia (2% in the Gazyvaro plus chlorambucil arm and 4% in the rituximab plus chlorambucil arm) and late onset neutropenia (16% in the Gazyvaro plus chlorambucil arm and 12% in the rituximab plus chlorambucil arm) were also reported (see section 4.4). 
te odgođene neutropenije (16% u skupini liječenoj lijekom Gazyvaro i klorambucilom te 12% u skupini liječenoj rituksimabom i klorambucilom) (vidjeti dio 4.4).
In the pivotal studies (BO21223/GALLIUM, GAO4753g/GADOLIN) in iNHL, patients 65 years or older experienced more serious adverse events and adverse events leading to withdrawal or death than patients < 65 years of age. 
Indolentni ne-Hodgkinov limfom, uključujući folikularni limfom U ključnim ispitivanjima kod iNHL-a (BO21223/GALLIUM, GAO4753g/GADOLIN), ozbiljne nuspojave i nuspojave koje su dovele do prekida liječenja ili smrti češće su se javljale u bolesnika u dobi od 65 ili više godina nego u onih mlađih od 65 godina.
How Gazyvaro is given 
Kako se Gazyvaro primjenjuje
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. 
Prije uključivanja u ispitivanje bolesnici su morali imali dokumentiran KLL pozitivan na CD20 te ispunjavati jedan ili oba uvjeta za istodobno postojeće bolesti: rezultat bodovanja komorbiditeta
Four percent of patients treated with Gazyvaro plus chlorambucil experienced acute thrombocytopenia (occurring within 24 hours after the Gazyvaro infusion) (see section 4.4). 
Akutna trombocitopenija (koja se razvila unutar 24 sata nakon infuzije lijeka Gazyvaro) javila se u četiri posto bolesnika liječenih lijekom Gazyvaro i klorambucilom (vidjeti dio 4.4).
If the patient experienced an IRR during the previous infusion, start with administration at 25 mg/hr. 
Ako se tijekom prethodne infuzije razvila reakcija na infuziju, primjenu treba započeti brzinom od 25 mg/h.
Figure 5 Kaplan-Meier curve of INV-assessed progression-free survival in patients with previously untreated FL (Study BO21223/GALLIUM) 
‡ Kraj uvodnog liječenja = kraj razdoblja uvodnog liječenja, ne uključuje monoterapiju održavanja Slika 5 Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema ocjeni ispitivača u bolesnika s prethodno neliječenim FL-om (ispitivanje BO21223/GALLIUM)
One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL. 
· Djelatna tvar je obinutuzumab: 1000 mg/40 ml po bočici, što odgovara koncentraciji od 25 mg/ml prije razrjeđivanja.
Grades 3-5† Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL) 
3.-5. stupanj† Gazyvaro + kemoterapija*
In the pivotal clinical study BO21004/CLL11, 91% (40 out of 44) of evaluable patients treated with Gazyvaro were B-cell depleted (defined as CD19+ B-cell counts < 0.07 x 109/L) at the end of treatment period and remained depleted during the first 6 months of follow up. 
U ključnom kliničkom ispitivanju BO21004/CLL11, 91% (40 od 44) bolesnika dostupnih za procjenu koji su liječeni lijekom Gazyvaro imalo je depleciju B-stanica (koja se definira kao broj CD19+
Most frequently reported (≥ 5%) symptoms associated with an IRR were nausea, vomiting, diarrhoea, headache, dizziness, fatigue, chills, pyrexia, hypotension, flushing, hypertension, tachycardia, dyspnoea, and chest discomfort. 
proljev, glavobolja, omaglica, umor, zimica, pireksija, hipotenzija, navale crvenila, hipertenzija, tahikardija, dispneja i nelagoda u prsištu.
In the small subgroup of patients with deletion 17p, only a positive trend was observed compared to Clb (HR=0.42, p=0.0892); no benefit was observed compared to RClb. 
U svim je podskupinama rizik od progresije bolesti ili smrti bio smanjen u skupini koja je primala GClb u odnosu na onu koja je primala RClb i onu koja je primala Clb, osim u podskupini bolesnika s delecijom 17p. U malenoj podskupini bolesnika koji su imali deleciju 17p primijećen je samo pozitivan trend u odnosu na Clb (HR=0,42, p=0,0892); nije primijećena dobit u usporedbi s RClb.
Figure 6 Kaplan-Meier curve of IRC-assessed PFS in patients with FL # (Study GAO4753g/GADOLIN) 
Slika 6 Kaplan-Meierova krivulja PFS-a u bolesnika s FL-om# prema ocjeni neovisnog ocjenjivačkog povjerenstva (ispitivanje GAO4753g/GADOLIN)
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. 
Cijepljenje Sigurnost cijepljenja živim ili atenuiranim virusnim cjepivima nakon terapije lijekom Gazyvaro nije ispitivana.
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. 
Bolesnici su bili randomizirani u omjeru 1:1 za primanje lijeka Gazyvaro (n = 601 bolesnik) ili rituksimaba (n = 601 bolesnik) u kombinaciji s kemoterapijom
Day 1 (1,000 mg) 
1. dan (1000 mg)
Cases of gastro-intestinal perforation have been reported in patients receiving Gazyvaro, mainly in iNHL. 
U bolesnika liječenih lijekom Gazyvaro, uglavnom onih oboljelih od iNHL-a, prijavljeni su slučajevi gastrointestinalne perforacije.
Table 4 Chronic lymphocytic leukaemia: Standard infusion rate in the absence of IRRs/hypersensitivity and recommendations in case an IRR occurred with previous infusion 
Tablica 4 Kronična limfocitna leukemija: Standardna brzina infuzije u odsustvu reakcija na infuziju/preosjetljivosti i preporuke u slučaju da je tijekom prethodne infuzije nastupila reakcija na infuziju
Tumour lysis syndrome, hypokalaemia 
Sindrom lize tumora
No meaningful differences were seen between the arms in HRQOL or health status measures. 
Nisu primijećene značajne razlike između skupina s obzirom na kvalitetu života vezanu uz zdravlje i mjerila zdravstvenog statusa.
Hazard ratio (95% CI) p-value (Log-Rank test, stratified b) 
Omjer hazarda (95% CI) p-vrijednost (log-rang test, stratificiran b)
* Chemotherapy: Chlorambucil in CLL; bendamustine, CHOP, CVP in iNHL including FL § observed also during maintenance treatment with at least 2% higher incidence in Gazyvaro arm (BO21223) 
*Kemoterapija: klorambucil kod KLL-a; bendamustin, CHOP, CVP kod iNHL-a, uključujući FL
Hypotension, as a symptom of IRRs, may occur during Gazyvaro intravenous infusions. 
Tijekom intravenskih infuzija lijeka Gazyvaro može se pojaviti hipotenzija kao simptom reakcija na infuziju.
All Grades Gazyvaro + chemotherapy* (CLL, iNHL) followed by Gazyvaro maintenance (iNHL) 
(KLL, iNHL) nakon čega slijedi terapija održavanja lijekom Gazyvaro (iNHL)
Patients who achieved a complete or partial response to induction treatment (i.e. the initial 6 treatment cycles) with Gazyvaro in combination with bendamustine or have stable disease should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first). 
Bolesnici koji ostvare potpun ili djelomičan odgovor na uvodno liječenje (tj. na prvih 6 ciklusa liječenja) lijekom Gazyvaro u kombinaciji s bendamustinom ili koji imaju stabilnu bolest trebaju nastaviti primati monoterapiju lijekom Gazyvaro u dozi od 1000 mg kao terapiju održavanja jedanput svaka 2 mjeseca tijekom 2 godine ili do progresije bolesti (što god nastupi ranije).
Hazard ratio (95% CI) p-value (Log-Rank test, stratifiedb) Overall survival 
Omjer hazarda (95% CI) p-vrijednost (log-rang test, stratificiran b) Ukupno preživljenje
MARKETING AUTHORISATION NUMBER(S) 
Djelomičan odgovor (PR)
Infusion can be continued upon resolution of symptoms and, if the patient does not experience any IRR symptoms, the infusion rate escalation can resume at the increments and intervals as appropriate for the treatment dose (see Tables 4 and 5). 
Ako se ne pojave simptomi reakcije na infuziju, njezinu brzinu je moguće nastaviti postupno povećavati u intervalima koji odgovaraju dozi (vidjeti Tablice 4 i 5).
Vaccination with live virus vaccines is not recommended during treatment and until B-cell recovery because of the immunosuppressive effect of obinutuzumab (see section 4.4). 
Zbog imunosupresivnog učinka obinutuzumaba, cijepljenje živim virusnim cjepivima se ne preporučuje tijekom trudnoće niti prije normalizacije broja B stanica (vidjeti dio 4.4).
Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first). 
Bolesnici koji ostvare potpun ili djelomičan odgovor na uvodno liječenje lijekom Gazyvaro u kombinaciji s kemoterapijom trebaju nastaviti primati terapiju održavanja samo lijekom Gazyvaro u dozi od 1000 mg jedanput svaka 2 mjeseca tijekom 2 godine ili do progresije bolesti (što god nastupi ranije).
· red eye · cold sores · depression, anxiety · night sweats · flu (influenza) · weight increase · lymph node pain · runny or blocked nose · eczema · nose or throat inflammation · pain in mouth or throat 
· umor · omaglica · glavobolja · proljev · vrućica, navale crvenila ili zimica
The rate of infusion can be escalated in increments up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr. 
Brzinu infuzije moguće je povećavati za 50 mg/h svakih 30 minuta do maksimalne brzine od 400 mg/h.
· muscle and bone pain in your chest · skin cancer (squamous cell carcinoma) · bone pain, pain in arms and legs · irregular heart beat (atrial fibrillation), heart failure · problems with urinating, urinary incontinence · high blood pressure · problems with digestion (e.g. heartburn), inflammation of the intestine, haemorrhoids · changes shown in blood tests: 
· visok krvni tlak · probavne tegobe (žgaravica), upala crijeva, hemoroidi · promjene u krvnoj slici:
If you miss your appointment, make another one as soon as possible. 
Ako propustite primiti dozu lijeka Gazyvaro, dogovorite novi termin što je prije moguće.