natgillin/translations-raw huggingface dataset:
In clinical trials, 96 % of 1,497 healthy infants, children, adolescents and adults given a 3 dose course of a previous formulation of Merck’s recombinant hepatitis B vaccine developed a protective level of antibodies against hepatitis B virus surface antigen ( 10 IU/l).
U kliničkim ispitivanjima, 96% od 1497 zdrave dojenčadi, djece, adolescenata i odraslih koji su primili ciklus od 3 doze prethodne formulacije Merckovog rekombinantnog cjepiva protiv hepatitisa B razvilo je zaštitnu razinu protutijela protiv površinskog antigena virusa hepatitisa B (10 IU/l).
In clinical trials, 97% of patients who responded had a complete response at doses 24 micrograms/kg/day.
U kliničkim je ispitivanjima kompletan odgovor postignut pri dozi od  24 mikrograma/kg/dan u 97% ispitanika koji su odgovorili na terapiju.
In clinical trials, a higher incidence of HFSR was observed in Asian (in particular Japanese) patients treated with Stivarga as compared with Caucasians (see section 4.2).
U kliničkim ispitivanjima opažena je viša incidencija kožne reakcije na šakama i stopalima u bolesnika azijskog podrijetla (osobito Japanaca) liječenih lijekom Stivarga u usporedbi s bijelcima (vidjeti dio 4.2).
In clinical trials, a higher incidence of severe liver function test abnormalities and hepatic dysfunction was observed in Asian (in particular Japanese) patients treated with Stivarga as compared with Caucasians (see section 4.2).
U kliničkim ispitivanjima opažena je viša incidencija teških poremećaja rezultata testova jetrene funkcije i poremećaja funkcije jetre u bolesnika azijskog podrijetla (osobito Japanaca) liječenih lijekom Stivarga u usporedbi s bijelcima (vidjeti dio 4.2).
In clinical trials, a higher incidence of severe liver injury with fatal outcome was observed in Japanese patients (~1.5%) treated with Stivarga compared with non- Japanese patients (<0.1%).
U kliničkim ispitivanjima, viša incidencija teškog oštećenja jetre sa smrtnim ishodom uočena je u japanskih bolesnika (~1,5%) koji su bili liječeni lijekom Stivarga u usporedbi s bolesnicima koji nisu japanskog podrijetla (<0,1%).
In clinical trials, a patient’s anti-thyroid peroxidase (anti-TPO) antibody status prior to treatment was not indicative for the development of a thyroid related adverse event.
U kliničkim ispitivanjima, status protutijela na antitiroidne peroksidaze (anti-TPO) u bolesnika prije liječenja nije bio indikativan za razvoj štetnog događaja povezanog sa štitnjače.
In clinical trials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa.
U kliničkim je ispitivanjima dokazana povećana osjetljivost jajnika na folitropin alfa kada se davao zajedno s lutropinom alfa.
In clinical trials, background therapies included metformin, a sulfonylurea, a thiazolidinedione, or a combination of oral glucose-lowering medicinal products.
U kliničkim ispitivanjima, osnovna terapija uključivala je metformin, sulfonilureju, tiazolidindion ili kombinaciju oralnih lijekova za snižavanje glukoze u krvi.
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF]
U kliničkim ispitivanjima klinički značajna produljenja QTc intervala (Fridericia QT korekcija [QTcF]
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF]
U kliničkim ispitivanjima, klinički značajna produljenja QTc (Fridericia QT korekcija [QTcF]
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF]
U kliničkim ispitivanjima, klinički značajna produljenja QTc intervala(Fridericia QT korekcija [QTcF]
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline
U kliničkim ispitivanjima klinički značajna produljenja QTc intervala (Fridericia QT korekcija [QTcF]
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
U kliničkim ispitivanjima, klinički značajna produljenja QTc (Fridericia QT korekcija [QTcF] ≥500 milisekundi [msek] bilo kada nakon početne vrijednosti u bolesnika s početnom vrijednošću QTcF< 500 milisekundi) bila su manje česta (0,1% do 1%) u bolesnika liječenih olanzapinom, bez značajnih razlika u povezanim kardijalnim događajima u usporedbi s placebom.
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF<500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
U kliničkim ispitivanjima, klinički značajna produljenja QTc (Fridericia QT korekcija [QTcF] ≥500 milisekundi [msek] bilo kada nakon početne vrijednosti u bolesnika s početnom vrijednošću QTcF< 500 milisekundi) bila su manje česta (0,1% do 1%) u bolesnika liječenih olanzapinom, bez značajnih razlika u povezanim kardijalnim događajima u usporedbi s placebom.
In clinical trials, decreased systolic blood pressure (> 35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure (> 25 mm Hg) was observed in 4% of patients within 45 minutes of Rapiscan administration.
U kliničkim ispitivanjima sniženje sistoličkog krvnog tlaka (> 35 mm Hg) primijećeno je u 7% bolesnika, a sniženje dijastoličkog krvnog tlaka (> 25 mm Hg) primijećeno je u 4% bolesnika unutar 45 minuta od primjene Rapiscana.
In clinical trials, decreases in left ventricular ejection fraction (LVEF) of 20% and below the lower limit of normal occurred in approximately 2% of sunitinib-treated GIST patients, 4% of cytokine-refractory MRCC patients, and 2% of placebo-treated GIST patients.
U kliničkim je ispitivanjima smanjenje istisne frakcije lijeve klijetke (engl. left ventricular ejection fraction, LVEF) za 20% i ispod donje granice normalnih vrijednosti zabilježeno u približno 2% bolesnika s GIST-om i 4% bolesnika s MRCC-om refraktornim na citokine koji su primali sunitinib te u 2% bolesnika s GIST-om koji su primali placebo.
In clinical trials, doses of elosulfase alfa were explored up to 4 mg/kg per week and no specific signs or symptoms were identified following the higher doses.
U kliničkim ispitivanjima elosulfaza alfa istražena je u dozama do 4 mg/kg/tjedno i nisu identificirani specifični znakovi ili simptomi s većim dozama.
In clinical trials, doses of up to 4 mg in monthly intervals have been used and isolated cases of overdoses with 8 mg occurred.
U kliničkim ispitivanjima primjenjivane su doze do 4 mg u mjesečnim intervalima i u izoliranim slučajevima došlo je do predoziranja s dozom od 8 mg.
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8].
U kliničkim je ispitivanjima pokazana djelotvornost protiv rotavirusnog gastroenteritisa uzrokovanog najčešćim genotipovima G1P[8], G2P[4], G3P[8], G4P[8] i G9P[8].
In clinical trials, elevations 3-fold the upper limit of normal (ULN) or greater in ALT occurred in 8.0% of patients treated with fingolimod 0.5 mg compared to 1.9% of placebo patients.
U kliničkim ispitivanjima, povišenje ALT u vrijednosti trostruko većoj od gornje granice normale (GGN) ili višoj, javilo se u 8,0% bolesnika liječenih fingolimodom od 0,5 mg, u usporedbi s 1,9% bolesnika liječenih placebom.
In clinical trials, general safety has been evaluated in more than 57000 adults vaccinated with ZOSTAVAX.
U kliničkim ispitivanjima opća sigurnost procijenjena je na više od 57 000 odraslih osoba cijepljenih cjepivom ZOSTAVAX.
In clinical trials, immune-related colitis was associated with evidence of mucosal inflammation, with or without ulcerations, and lymphocytic and neutrophilic infiltration.
U kliničkim je ispitivanjima imunološki uzrokovan kolitis bio povezan s dokazanom upalom sluznice, s ulceracijama ili bez njih i infiltracijom limfocita ili neutrofila.
In clinical trials, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory medicinal products, corticosteroids, and DMARDs) have not been observed.
U kliničkim ispitivanjima nisu primijećene interakcije između Kinereta i drugih lijekova (uključujući nesteroidne protuupalne lijekove, kortikosteride i lijekove koji modificiraju tijek bolesti).
In clinical trials, mycophenolate mofetil was used in patients without response to corticosteroid therapy, or who had an LFT elevation during corticosteroid tapering that was not responsive to an increase in the dose of corticosteroids (see the Summary of Product Characteristics for mycophenolate mofetil).
U kliničkim se ispitivanjima mikofenolat mofetil primjenjivao u bolesnika u kojih nije bilo odgovora na kortikosteroidnu terapiju ili koji su imali povišenu vrijednost LFT tijekom smanjivanja doze kortikosteroida koja nije odgovarala na povećanje doze kortikosteroida (vidjeti Sažetak opisa svojstava lijeka za mikofenolat mofetil).
In clinical trials, Neulasta has been safely administered 14 days before chemotherapy.
U kliničkim se ispitivanjima Neulasta sigurno primjenjivala 14 dana prije kemoterapije.
In clinical trials, no PNH or aHUS patients experienced an infusion reaction which required discontinuation of Soliris.
U kliničkim ispitivanjima niti jedan bolesnik s PNH-om ili aHUS-om nije imao reakciju na infuziju koja bi zahtijevala prekid primjene lijeka Soliris.
In clinical trials, NovoThirteen has been administered to 56 patients with congenital factor XIII A- subunit deficiency (1043 doses of NovoThirteen).
U kliničkim ispitivanjima NovoThirteen je bio primijenjen u 56 bolesnika s prirođenim nedostatkom faktora XIII A-podjedinice (1043 doze lijeka NovoThirteen).
In clinical trials, ONIVYDE was administered at doses up to 240 mg/m2 to patients with various cancers.
U kliničkim ispitivanjima ONIVYDE je primijenjen u dozama do 240 mg/m2 u bolesnika s različitim vrstama raka.
In clinical trials, Optruma did not stimulate the postmenopausal uterine endometrium.
U kliničkim istraživanjima Optruma nije stimulirala endometrij maternice u postmenopauzi.
In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Silgard.
U kliničkim ispitivanjima oralna ili druga sredstva za sprječavanje trudnoće (npr. pilula) nisu smanjile razinu zaštite koju pruža Silgard.
In clinical trials, over 7,900 depressed patients have received Thymanax.
Preko 7 900 depresivnih bolesnika primili su Thymanax u kliničkim studijama.
In clinical trials, over 7,900 depressed patients have received Valdoxan.
Preko 7 900 depresivnih bolesnika primili su Valdoxan u kliničkim studijama.
In clinical trials, patients over 75 years of age had a higher incidence of serious and severe adverse events irrespective of a causal relationship to treatment with epoetin theta.
U kliničkim ispitivanjima, veća incidencija ozbiljnih i teških nuspojava, neovisno o uzročno- posljedičnoj vezi s liječenjem epoetinom theta, zabilježena je u bolesnika starijih od 75 godina.
In clinical trials, patients who developed thyroid events were permitted to receive re-treatment with LEMTRADA.
U kliničkim ispitivanjima, bolesnicima koji su razvili događaje povezane sa štitnjačom dopušteno je primati ponovno liječenje lijekom LEMTRADA.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/l as measured in a central laboratory.
U kliničkim ispitivanjima, pacijentice s teškim nedostatkom FSH i LH definirane su razinom endogenog LH u serumu <1,2 IU/l, kako je izmjereno u središnjem laboratoriju.
In clinical trials, Pegasys treatment was associated with decreases in both total white blood cell (WBC) count and absolute neutrophil count (ANC), usually starting within the first 2 weeks of treatment (see section 4.8).
U kliničkim ispitivanjima liječenje lijekom Pegasys povezivano je s padom ukupnoga broja leukocita (engl. white blood cell, WBC) i apsolutnoga broja neutrofila (ABN), obično unutar prva 2 tjedna liječenja (vidjeti dio 4.8).
In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving Avastin.
U kliničkim je ispitivanjima proteinurija prijavljena u između 0,7% i 54,7% bolesnika koji su primali Avastin.
In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
U kliničkim ispitivanjima osip je prijavljen u 4% bolesnika, a svrbež u 1,5% bolesnika.
In clinical trials, Ristempa has been safely administered 14 days before chemotherapy.
U kliničkim se ispitivanjima Ristempa sigurno primjenjivala 14 dana prije kemoterapije.
In clinical trials, scheduled dinutuximab doses of up to 120 mg/m2 (60 mg/m2/day) have been administered with an adverse reaction profile similar to that described in section 4.8. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
U kliničkim ispitivanjima, planirane doze dinutuksimaba od najviše 120 mg/m2 (60 mg/m2/dan) su primjenjivane s profilom nuspojava sličnim onome opisanom u dijelu 4.8. U slučaju predoziranja bolesnike treba pomno nadzirati kako bi se uočili znakovi ili simptomi nuspojava, te treba uvesti odgovarajuće simptomatsko liječenje.
In clinical trials, sixty seven percent (67 %) of the patients experienced at least one infusion- associated reaction (see section 4.8).
U kliničkim je ispitivanjima šezdeset i sedam posto (67%) bolesnika doživjelo barem jednu reakciju povezanu s infuzijom (vidjeti dio 4.8).
In clinical trials, sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction (see section 4.8).
U kliničkim je ispitivanjima šezdeset i sedam posto (67%) bolesnika doživjelo barem jednu reakciju povezanu s infuzijom (vidjeti dio 4.8).
In clinical trials, smaller bleeding sites (< 10 cm2) used 0.5 g to 1 g on average.
U kliničkim ispitivanjima, za manja mjesta krvarenja (<10 cm2) prosječno se koristi od 0,5 g do 1 g.
In clinical trials, spinal/cervical cord compression (SCC) was observed both in patients receiving Vimizim and patients receiving placebo.
U kliničkim ispitivanjima, kompresija kralježničke/cervikalne moždine prijavljena je kod bolesnika koji su primili i Vimizim i placebo.
In clinical trials, the crude incidence rate of malignancy was the same in the Kineret-treated patients and the placebo-treated patients and did not differ from that in the general population.
U kliničkim ispitivanjima neobrađena stopa incidencije malignih bolesti bila je ista kao i u bolesnika liječenih Kineretom te u bolesnika koji su primali placebo i nije se razlikovala od one u općoj populaciji.
In clinical trials, the incidence rate for syncope is uncommon and did not differ between lacosamide treated epilepsy patients (0.1%) and placebo treated epilepsy patients (0.3%).
U kliničkim istraživanjima stopa incidencije sinkope manje je česta i nije se razlikovala između bolesnika s epilepsijom koji su liječeni lakozamidom (0,1%) i bolesnika s epilepsijom koji su dobivali placebo (0,3%).
In clinical trials, the maximum accidental overdose was 10 times (bolus) or 3.5 times the infusion dose normally administered and bleeding was the most frequently observed adverse event.
U kliničkim ispitivanjima, maksimalno slučajno predoziranje bilo je 10 puta (bolus) ili 3,5 puta veće od obično primijenjene infuzijske doze, a najčešće opažen štetni događaj bilo je krvarenje.
In clinical trials, the median time to first occurrence of left ventricular dysfunction, cardiac failure and LVEF decrease was between 2 to 5 months.
U kliničkim je ispitivanjima medijan vremena do prve pojave disfunkcije lijeve klijetke, zatajenja srca i smanjenja LVEF iznosio 2 do 5 mjeseci.
In clinical trials, the median time to onset of the first occurrence of left ventricular dysfunction, cardiac failure and LVEF decrease was between 2 and 5 months.
U kliničkim je ispitivanjima medijan vremena do prve pojave disfunkcije lijeve klijetke, zatajenja srca i smanjenja LVEF bio između 2 i 5 mjeseci.
In clinical trials, the most common adverse reactions were blurred vision, eye irritation and eye pain, occurring in approximately 2% to 7% patients.
U kliničkim ispitivanjima najčešće nuspojave bile su zamućenje vida, iritacija oka i bol u oku, a pojavile su se kod približno 2% do 7% bolesnika.
In clinical trials, the overall incidence of arterial thromboembolic reactions ranged up to 3.8% in the Avastin containing arms compared with up to 2.1% in the chemotherapy control arms.
U kliničkim je ispitivanjima ukupna incidencija arterijskih tromboembolijskih reakcija dosezala do 3,8% u skupinama čija je terapija obuhvaćala Avastin te do 2,1% u kontrolnim skupinama liječenima kemoterapijom.
In clinical trials, the use of Nimenrix as a booster following primary vaccination with Nimenrix or other meningococcal vaccines (quadrivalent meningococcal A, C, W, and Y-DT conjugate vaccine or monovalent group C conjugate vaccines) was evaluated.
U kliničkim ispitivanjima procijenjena je primjena Nimenrixa kao docjepljivanja nakon primarnog cijepljenja cjepivom Nimenrix ili drugim meningokoknim cjepivima (kvadrivalentno konjugirano meningokokno cjepivo A, C, W i Y-DT ili monovalentna konjugirana cjepiva grupe C ).
In clinical trials, there was an increased incidence of these events in older people and those with a prior history of cardiac disease.
U kliničkim je ispitivanjima zabilježena povećana incidencija tih događaja u starijih ljudite u onih koji su ranije bolovali od bolesti srca.
In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/l.
U kliničkim ispitivanjima, ove pacijentice definirane su razinom endogenog LH u serumu <1,2 IU/l.
In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
U kliničkim istraživanjima to je okarakterizirano s dvije ili više akutnih egzacerbacija (relapsa) u zadnje tri godine bez dokaza stalnog napredovanja bolesti između relapsa; AVONEX usporava progresiju onesposobljivanja (invalidnosti) i smanjuje učestalost relapsa.
In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1).
U kliničkim ispitivanjima ovo je karakterizirano s dvije ili više akutne egzacerbacije unutar posljednje dvije godine (vidjeti dio 5.1).
In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2 and a further dose reduction was required to manage adverse effects.
U kliničkim se ispitivanjima primjena topotekana obustavljala ako je njegova doza smanjena na 1,0 mg/m2 i ukoliko je postojala potreba za daljnjim smanjenjem doze u svrhu kontrole nuspojava lijeka.
In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2 and a further dose reduction was required to manage adverse effects.
U kliničkim se ispitivanjima primjena topotekana obustavljala ako je njegova doza smanjena na 1,0 mg/m2 i ukoliko je postojala potreba za daljnjim smanjenjem doze u svrhu kontrole štetnih učinaka lijeka.
In clinical trials, topotecan was discontinued if the dose needed to be reduced below 1.5 mg/m2.
U kliničkim se ispitivanjima primjena topotekana obustavljala ako je doza smanjena ispod 1,5 mg/m2.
In clinical trials, transient or intermittent mild and moderate elevations of hepatic transaminases have been reported commonly with RoActemra treatment, without progression to hepatic injury (see section 4.8).
U kliničkim su ispitivanjima pri liječenju lijekom RoActemra često prijavljena prolazna ili povremena blaga do umjerena povišenja vrijednosti jetrenih transaminaza, s time da nije nastupilo oštećenje jetre (vidjeti dio 4.8).
In clinical trials, treatment with bosutinib continued until disease progression or until it was no longer tolerated by the patient.
U kliničkim ispitivanjima liječenje bosutinibom trajalo je do progresije bolesti ili dok ga bolesnik više nije tolerirao.
In clinical trials, tumour haemorrhage occurred in approximately 2% of patients with GIST.
U kliničkim je ispitivanjima tumorsko krvarenje nastupilo u približno 2% bolesnika s GIST-om.
In clinical trials, up to 3% of adult patients tested seropositive at least once during the study for antibodies capable of neutralising the biologic effects of anakinra.
U kliničkim ispitivanjima do 3% testiranih odraslih bolesnika su bili seropozitivni najmanje jednom tijekom ispitivanja na protutijela sposobna za neutralizaciju bioloških učinaka anakinre.
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Neutropenija je obično zabilježena kod istodobne primjene olanzapina i valproata (vidjeti dio 4.8).
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
U kliničkim ispitivanjima pogoršanje simptoma parkinsonizma i halucinacije zabilježeni su vrlo često te češće u odnosu na placebo (vidjeti dio 4.8), a olanzapin nije bio učinkovitiji od placeba u liječenju psihotičkih simptoma.
In clinical trials, Xtandi was administered without regard to food.
U kliničkim je ispitivanjima Xtandi bio primjenjivan bez obzira na hranu.
In clinically stable patients, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Kod kliničkih stabilnih bolesnika prebacivanje na peroralnu terapiju azolima bilo je dopušteno nakon najmanje 5 do 10 dana liječenja anidulafunginom.
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.
U 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) primijećena je smanjena incidencija reakcija na infuziju svih stupnjeva.
In CLL patients, co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
U bolesnika s KLL-om čini se da istodobna primjena lijeka MabThera nije utjecala na farmakokinetiku fludarabina niti ciklofosfamida.
In CLL patients, if the previous infusion rate was not well tolerated, instructions for the Cycle 1, Day 1 and Day 2 infusion rate should be used for subsequent cycles (see Table 5 in section 4.2).
U bolesnika s KLL-om, ako bolesnik nije dobro podnio prethodnu brzinu infuzije, u sljedećim je ciklusima potrebno slijediti smjernice za brzinu infuzije koja se primjenjuje 1. i 2. dana 1.ciklusa (vidjeti Tablicu 5 u dijelu 4.2).
In CLL Zydelig treatment is used in combination with another medicine (rituximab or ofatumumab) in patients who have certain high-risk factors or in patients whose cancer has come back after at least one previous treatment.
U KLL-u se liječenje Zydeligom primjenjuje u kombinaciji s drugim lijekom (rituksimabom ili ofatumumabom) u bolesnika koji imaju određene visokorizične čimbenike ili u bolesnika čiji se rak vratio nakon najmanje jednog prethodnog liječenja.