FrancophonIA/ELRC3.0 huggingface dataset:
English: PFS rate at 12 months and 95% CI: 18% (14, 23)
Croatian: Stopa PFS nakon 12 mjeseci i 95% CI: 18% (14, 23)
English: Additionally, for patients who experienced an event, Table 6 presents the percentage of patients who required high-dose corticosteroids (at least 40 mg daily prednisone equivalents).
Croatian: Dodatno u bolesnika koji su imali nuspojavu, tablica 6 pokazuje postotak bolesnika koji su bili u potrebi primati visoke doze kortikosteroida (najmanje u dozi koja je ekvivalent 40 mg prednizona na dan).
English: 10 months
Croatian: 10 mjeseci
English: Guidelines for permanent discontinuation or withholding of doses are described in Tables 3A and 3B for YERVOY as monotherapy, and in Table 3C for YERVOY in combination with nivolumab or administration of the second phase of treatment (nivolumab monotherapy) following combination treatment.
Croatian: Smjernice za trajni prekid liječenja ili odgodu primjene doze opisane su u Tablicama 3A i 3B za YERVOY u monoterapiji te u Tablici 3C za YERVOY u kombinaciji s nivolumabom ili primjenu druge faze liječenja (monoterapije nivolumabom) nakon kombinirane terapije.
English: These medicines may interfere with the effect of YERVOY.
Croatian: Ti lijekovi mogu ometati djelovanje lijeka YERVOY.
English: Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80
Croatian: Pentetatna kiselina (dietilentriaminpentaacetatna kiselina) Polisorbat 80
English: Endocrine:
Croatian: Endokrini poremećaji:
English: Therefore, ipilimumab should not be used in children younger than 12 years of age.
Croatian: Stoga se ipilimumab ne smije primjenjivati u djece mlađe od 12 godina.
English: Table 12: Efficacy results in intermediate/poor risk patients (CA209214)
Croatian: Tablica 12: Rezultati za djelotvornost u bolesnika s umjerenim/visokim rizikom (CA209214)
English: Changes in test results
Croatian: Promjene laboratorijskih nalaza
English: In the Phase 3 study MDX010-20, (see section 5.1), patients received a median of 4 doses (range 1-4).
Croatian: U ispitivanju MDX010-20 faze III (vidjeti dio 5.1) medijan doza koji su bolesnici primili iznosio je 4 doze (raspon 1-4).
English: A summary of adverse events in adolescents 12 years of age and older, as well as adults, is presented in Table 7.
Croatian: Sažetak nuspojava u adolescenata u dobi od 12 i više godina, kao i u odraslih, prikazan je u Tablici 7.
English: Among 131 patients who discontinued the combination due to adverse reaction after 28 months of follow-up, the ORR was 71% (93/131) with 20% (26/131) achieving a complete response and median OS was not reached.
Croatian: Među 131 bolesnikom koji je nakon 28 mjeseci praćenja prekinuo liječenje kombiniranom terapijom zbog nuspojave, ORR je iznosio 71% (93/131), 20% (26/131) bolesnika ostvarilo je potpuni odgovor, a medijan OS a nije postignut.
English: The YERVOY infusion should not be infused at the same time in the same intravenous line with other agents.
Croatian: Infuzija lijeka YERVOY ne smije se primijeniti u isto vrijeme ni kroz istu intravensku liniju s drugim lijekovima.
English: There were no reports of severe or very severe (Grade 3 or 4) adrenal insufficiency, hyperthyroidism, or hypothyroidism.
Croatian: Nisu bili zabilježeni teški ili vrlo teški stupnjevi (3. ili 4. stupanj) insuficijencije nadbubrežne žlijezde, hipertireoidizma ili hipotireoidizma.
English: Studies to evaluate the mutagenic and carcinogenic potential of ipilimumab have not been performed.
Croatian: Ispitivanja kojima bi se procijenile mutagenost i kancerogenost ipilimumaba nisu provedena.
English: Stable disease was achieved in two patients at the ipilimumab 5mg/kg dose, one with a duration of > 22 months.
Croatian: Stabilna bolest postignuta je u dva bolesnika na ipilimumabu u dozi od 5 mg/kg, kod jednog u trajanju > 22 mjeseca.
English: The use of systemic corticosteroids after starting ipilimumab treatment does not appear to impair the efficacy of ipilimumab.
Croatian: Primjena sistemskih kortikosteroida nakon početka liječenja ipilimumabom čini se da ne narušava djelotvornost ipilimumaba.
English: Since gastrointestinal haemorrhage is an adverse reaction with ipilimumab (see section 4.8), patients who require concomitant anticoagulant therapy should be monitored closely.
Croatian: Budući da je gastrointestinalno krvarenje nuspojava ipilimumaba (vidjeti dio 4.8), bolesnici kojima je potrebna istovremena terapija antikoagulansima moraju biti pod strogim nadzorom.
English: When YERVOY is given following prior vemurafenib there may be an increased risk of skin side-effects.
Croatian: Kada se YERVOY daje nakon prethodne primjene vemurafeniba, povećan je rizik od kožnih nuspojava.
English: Treatment with YERVOY in combination with nivolumab, should be continued for the four doses of combination therapy as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Croatian: Liječenje lijekom YERVOY u kombinaciji s nivolumabom treba nastaviti tijekom četiri ciklusa kombinirane terapije sve dok je primjetna klinička korist ili do trenutka kada bolesnik više ne podnosi liječenje.
English: In patients with melanoma who received ipilimumab, the mean peripheral blood absolute lymphocyte counts (ALC) increased throughout the induction dosing period.
Croatian: U bolesnika s melanomom koji su primali ipilimumab, srednji apsolutni broj limfocita u perifernoj krvi povećavao se tijekom cijelog uvodnog razdoblja primjene.
English: More than one vial of YERVOY concentrate may be needed to give the total dose for the patient.
Croatian: Može biti potrebno više od jedne bočice koncentrata lijeka YERVOY da bi se bolesniku dala ukupna doza.
English: Ipilimumab was administered every 3 weeks for 4 doses and then every 12 weeks thereafter in the absence of dose limiting toxicity (DLT) and disease progression.
Croatian: Ipilimumab se primjenjivao svaka 3 tjedna po jedna doza ukupno 4 doze i onda svakih 12 tjedana u slučaju da nije bilo toksičnosti koja utječe na primjenu sljedeće doze (engl. dose limiting toxicity DLT) i progresije bolesti.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting ipilimumab to treat immune-related adverse reactions.
Croatian: Međutim, sistemski kortikosteroidi ili drugi imunosupresivi mogu se početi primjenjivati nakon početka terapije ipilimumabom za liječenje imunološki uzrokovanih nuspojava.
English: YERVOY can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting to up to 5 times the original volume of concentrate (up to 4 parts of diluent to 1 part of concentrate).
Croatian: YERVOY se može koristiti za intravensku primjenu: bez razrjeđivanja, nakon prijenosa u spremnik za infuziju pomoću odgovarajuće sterilne štrcaljke; ili nakon razrjeđenja originalnog volumena koncentrata do 5 puta (do 4 dijela otopine za razrjeđivanje na 1 dio koncentrata).
English: The amount of YERVOY you will be given will be calculated based on your body weight.
Croatian: Količina lijeka YERVOY koju ćete primiti izračunat će se na temelju
English: Fertility studies have not been performed.
Croatian: Ispitivanja utjecaja na plodnost nisu provedena.
English: Less than 2% of patients with advanced melanoma who received ipilimumab in Phase 2 and 3 clinical trials developed antibodies against ipilimumab.
Croatian: Manje od 2% bolesnika s uznapredovalim melanomom koji su primili ipilimumab u kliničkim ispitivanjima faze II i III razvilo je protutijela na ipilimumab.
English: Other in-use storage time and conditions are the responsibility of the user.
Croatian: Za drugačije uvjete i trajanje čuvanja pripremljenog lijeka odgovoran je korisnik.
English: Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes.
Croatian: Ostavite odgovarajući broj bočica lijeka YERVOY da odstoje na sobnoj temperaturi približno 5 minuta.
English: Ipilimumab with nivolumab was continued beyond progression in 29% of patients.
Croatian: Liječenje ipilimumabom u kombinaciji s nivolumabom nastavilo se nakon progresije u 29% bolesnika.
English: • The importance of carrying the detachable wallet-sized Patient Alert Card at all times to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals).
Croatian: • Naglasiti da je važno da bolesnik uvijek sa sobom nosi Karticu s upozorenjima za bolesnika, koja se može odvojiti od upute i držati u novčaniku, kako bi je mogao pokazati pri svakom posjetu nekom drugom zdravstvenom radniku koji nije propisao lijek (npr. radnici u hitnoj službi).
English: Any other organ system adverse reactions that are considered immune-related should be graded according to CTCAE.
Croatian: Sve nuspojave drugih organskih sustava koje se smatraju imunološki uzrokovane trebaju se stupnjevati u skladu s CTCAE.
English: No controlled studies have been conducted to evaluate the pharmacokinetics of ipilimumab in the paediatric population or in patients with hepatic or renal impairment.
Croatian: Nisu provedena kontrolirana ispitivanja kako bi se procijenila farmakokinetika ipilimumaba u pedijatrijske populacije ili u bolesnika s oštećenjem funkcije jetre ili bubrega.
English: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events.
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events,
English: A Phase 3, double-blind study enrolled patients with advanced (unresectable or metastatic) melanoma who had previously been treated with regimens containing one or more of the following: IL-2, dacarbazine, temozolomide, fotemustine, or carboplatin.
Croatian: U dvostruko slijepo ispitivanje faze III bili su uključeni bolesnici s uznapredovalim (neresektabilnim ili metastatskim) melanomom prethodno liječeni režimima koji sadrže jedan ili više sljedećih lijekova: IL-2, dakarbazin, temozolomid, fotemustin ili karboplatin.
English: It contains 2.3 mg sodium per ml of concentrate.
Croatian: Ovaj lijek sadrži 2,3 mg natrija po ml koncentrata.
English: Adrenal insufficiency, hyperthyroidism, and hypothyroidism of any severity were each reported in 2% of patients.
Croatian: Insuficijencija nadbubrežne žlijezde, hipertireoidizam i hipotireoidizam svih stupnjeva težine bili su zabilježeni svaki u 2% bolesnika.
English: It is currently unknown if the corticosteroid treatment reverses the gland dysfunction.
Croatian: Za sada nije poznato normalizira li liječenje kortikosteroidima poremećenu funkciju žlijezde.
English: YERVOY may cause changes in the results of tests carried out by your doctor.
Croatian: YERVOY može promijeniti rezultate pretraga koje će Vam napraviti liječnik.
English: However, patients with brain metastases were included in this study, if they were free of neurologic symptoms related to metastatic brain lesions and if they did not require or receive systemic corticosteroid therapy in the 10 days prior to beginning ipilimumab therapy (see section 5.1).
Croatian: No, bolesnici s metastazama u mozgu su bili uključeni u ovu studiju, ako nisu imali neurološke simptome povezane s metastatskim lezijama u mozgu i ako nisu trebali ili primali sistemsku kortikosteroidnu terapiju 10 dana prije početka terapije ipilimumabom (vidjeti dio 5.1).
English: Adverse events leading to discontinuation in the 10 mg/kg and 3 mg/kg groups occurred in 31% and 19% of patients, with AEs leading to death in 4 and 2 patients, respectively.
Croatian: Nuspojave koje su dovele do prekida terapije u skupinama 10 mg/kg i 3 mg/kg nastupile su u 31% i 19% bolesnika, s nuspojavama koje su dovele do smrti u 4 odnosno 2 bolesnika.
English: Rates of immune-related adverse reactions in HLA-A2*0201 positive patients who received ipilimumab in MDX010-20 were similar to those observed in the overall clinical program.
Croatian: Stope imunološki uzrokovanih nuspojava u bolesnika s pozitivnim HLA-A2*0201 koji su primali ipilimumab u ispitivanju MDX010-20 bile su slične onima primijećenima u ukupnom kliničkom programu.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of ipilimumab (see section 4.4 for management of immune-related adverse reactions).
Croatian: Većina tih nuspojava, uključujući teške reakcije, povukla se nakon uvođenja odgovarajuće medikamentozne terapije ili prekida primjene ipilimumaba (vidjeti dio 4.4 za zbrinjavanje imunološki posredovanih nuspojava).
English: (In clinical trials, methylprednisolone 2 mg/kg/day has been used).
Croatian: (U kliničkim ispitivanjima koristio se metilprednizolon u dozi od 2 mg/kg/dan).
English: In intravenous repeat-dose toxicology studies in monkeys, ipilimumab was generally well tolerated.
Croatian: U toksikološkim ispitivanjima ponovljene intravenske doze u majmuna, ipilimumab se općenito dobro podnosio.
English: You will be treated with YERVOY once every 3 weeks, for a total of 4 doses.
Croatian: Primat ćete YERVOY jedanput svaka 3 tjedna do ukupno 4 doze.
English: DCR (%) (95% CI) Median PFS (months) (95% CI)
Croatian: DCR (%) (95% CI) Medijan PFS (mjeseci) (95% CI)
English: The volume of YERVOY concentrate to prepare the dose (ml) = the total dose in mg, divided by 5 (the YERVOY concentrate strength is 5 mg/ml).
Croatian: Volumen koncentrata lijeka YERVOY za pripremu doze (ml) = ukupna doza u mg, podijeljena s 5 (jačina koncentrata lijeka YERVOY je 5 mg/ml).
English: The types of irARs were consistent with the adult experience, with the most commonly reported irARs across all groups in the categories of gastrointestinal (0 [3 mg/kg], 62.5% [5 mg/kg], and 44.4% [10 mg/kg]), hepatic function (0 [3 mg/kg], 75.0% [5 mg/kg], 33.3% [10 mg/kg]), and skin (0 [3 mg/kg], 25.0% [5 mg/kg], 33.3% [10 mg/kg]) events.
Croatian: Vrste irAR-a bile su u skladu s iskustvom u odraslih a najčešće prijavljeni irAR-ovi u svim skupinama odnosili su se na događaje vezane uz probavni sustav (0 [3 mg/kg], 62,5% [5 mg/kg], i 44,4% [10 mg/kg]), jetrenu funkciju (0 [3 mg/kg], 75,0% [5 mg/kg], 33,3% [10 mg/kg]), i kožu (0 [3 mg/kg], 25,0% [5 mg/kg], 33,3% [10 mg/kg]).
English: The effects of ipilimumab on prenatal and postnatal development were investigated in a study in cynomolgus monkeys.
Croatian: Učinci ipilimumaba na prenatalni i postnatalni razvoj ispitivani su u jednom istraživanju na makaki majmunima.
English: • Brief introduction to ipilimumab and the purpose of this risk minimisation tool.
Croatian: • Kratke uvodne informacije o ipilimumabu i namjeni brošure za minimizaciju rizika.
English: Management of these adverse reactions may also require systemic high-dose corticosteroid therapy if demonstrated or suspected to be immune-related (see section 4.4 for detailed management guidelines).
Croatian: Za zbrinjavanje tih nuspojava može biti potreba i terapija visokim dozama sistemskih kortikosteroida ukoliko se dokaže ili postoji sumnja da su nuspojave imunološki uzrokovane (vidjeti dio 4.4 za detaljne smjernice o liječenju).
English: YERVOY must be stored in a refrigerator (2°C to 8°C).
Croatian: YERVOY se mora čuvati u hladnjaku (2°C do 8°C).
English: Secondary efficacy endpoints of best overall response rate (BORR), stable disease (SD), disease control rate (DCR), and progression free survival (PFS) were based on mWHO criteria and determined by the investigator's assessment.
Croatian: Sekundarne mjere ishoda djelotvornosti najbolja ukupna stope odgovora, (engl. best overall response rate BORR) stabilna bolest (engl. stable disease -SD), stopa kontrole bolesti (engl.disease control rate DCR) i preživljenje bez progresije (engl.progression free survival PFS) bile su temeljene na modificiranim WHO kriterijima i određene procjenom ispitivača.
English: While most immune-related adverse reactions occurred during the induction period, onset months after the last dose of ipilimumab has also been reported.
Croatian: Dok je većina imunološki uzrokovanih nuspojava nastala tijekom razdoblja uvodne terapije, zabilježen je i nastup mjesecima nakon posljednje doze lijeka ipilimumab.
English: In peripheral blood of patients with melanoma, a mean increase in the percent of activated HLA-DR+ CD4+ and CD8+ T cells was observed after treatment with ipilimumab, consistent with its mechanism of action.
Croatian: U perifernoj krvi bolesnika s melanomom bilo je primijećeno povećanje srednje vrijednosti postotka aktiviranih HLA-DR+ CD4+ i CD8+ T stanica nakon liječenja ipilimumabom, što je u skladu s njegovim mehanizmom djelovanja.
English: 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).
Croatian: U kliničkim se ispitivanjima mofetilmikofenolat 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 mofetilmikofenolat ).
English: Unless otherwise specified, the data below reflect exposure to ipilimumab at 3 mg/kg in clinical trials of melanoma.
Croatian: Ukoliko nije naznačeno drugačije, niže navedeni podaci odražavaju izloženost ipilimumabu u dozi od 3 mg/kg u kliničkim ispitivanjima liječenja melanoma.
English: Pregnant monkeys received ipilimumab every 3 weeks from the onset of organogenesis in the first trimester through delivery, at exposure (AUC) levels either similar to or higher than those associated with the clinical dose of 3 mg/kg of ipilimumab.
Croatian: Skotne su majmunice primale ipilimumab svaka 3 tjedna od početka organogeneze u prvom tromjesečju sve do okota, a razine izloženosti (AUC) bile su slične ili više od onih kod kliničke primjene ipilimumaba u dozi od 3 mg/kg.
English: In addition, iritis, haemolytic anaemia, amylase elevations, multi-organ failure, and pneumonitis have been reported in patients treated with ipilimumab 3 mg/kg + gp100 peptide vaccine in MDX010-20.
Croatian: Osim toga, iritis, hemolitička anemija, povišene vrijednosti amilaze, višestruko zatajenje organa i pneumonitis zabilježeni su u bolesnika koji su primali ipilimumab u dozi od 3 mg/kg + gp100 peptidnog cjepiva u ispitivanju MDX010-20.
English: Increases in AST and ALT or total bilirubin should be evaluated to exclude other causes of hepatic injury, including infections, tumour progression, or concomitant medication and monitored until resolution.
Croatian: Povišene vrijednosti AST i ALT ili ukupnog bilirubina potrebno je procijeniti kako bi se isključili drugi uzroci oštećenja jetre, uključujući infekcije, napredovanje tumora ili istodobno primijenjene lijekove, te ih pratiti do potpunog nestanka.
English: It is not known whether ipilimumab gets into breast milk.
Croatian: Nije poznato izlučuje li se ipilimumab u majčino mlijeko.
English: • Follow-up of patients due to late onset (months after treatment) of irARs
Croatian: • Praćenje bolesnika zbog mogućeg kasnog nastupa imunološki uzrokovanih nuspojava (mjesecima nakon liječenja).
English: Additional adverse reactions not listed in Table 4 have been reported in patients who received other doses (either < or > 3 mg/kg) of ipilimumab in clinical trials of melanoma.
Croatian: Dodatne nuspojave koje nisu navedene u tablici 4 zabilježene su u bolesnika koji su primili drugačije doze (< ili > 3 mg/kg) ipilimumaba u kliničkim ispitivanjima liječenja melanoma.
English: When administered in combination with nivolumab, the CL of ipilimumab was unchanged in the presence of anti-ipilimumab antibodies and there was no evidence of altered toxicity profile.
Croatian: Kod primjene u kombinaciji s nivolumabom, klirens ipilimumaba nije se promijenio u prisutnosti protutijela na ipilimumab i nije bilo dokaza promjena u profilu toksičnosti.
English: Management recommendations for diarrhoea or colitis are based on severity of symptoms (per NCI-CTCAE v4 severity grading classification).
Croatian: Preporučeno liječenje proljeva ili kolitisa temelji se na težini simptoma (klasifikacija težine prema NCI-CTCAE v.4).
English: No new adverse drug reactions were reported in adolescents 12 years of age and older.
Croatian: Nisu prijavljene nove nuspojave u adolescenata u dobi od 12 i više godina.
English: Caution should be taken when ipilimumab is given following or in combination with a PD-1 or PD-L1 inhibitor.
Croatian: Potreban je oprez kada se ipilimumab primjenjuje nakon ili u kombinaciji s PD-1 ili PD-L1 inhibitorima.
English: YERVOY should not be used in children younger than 12 years of age.
Croatian: YERVOY se ne smije primjenjivati u djece mlađe od 12 godina.
English: Patients with a history of autoimmune disease (other than vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism), including those who require systemic immunosuppressive therapy for pre-existing active autoimmune disease or for organ transplantation graft maintenance, were not evaluated in clinical trials.
Croatian: Bolesnici s autoimunom bolešću u anamnezi (osim vitiliga i primjereno kontroliranih endokrinih deficijencija, kao što je hipotireoidizam), uključujući one kojima je potrebna sistemska imunosupresivna terapija zbog postojeće aktivne autoimune bolesti ili održavanja presatka nakon presađivanja organa nisu bili uključeni u klinička ispitivanja.
English: Patients with apparent tumour burden increase before completion of the induction period were continued on induction therapy as tolerated if they had adequate performance status.
Croatian: Bolesnici s vidljivim povećanjem tumorske mase prije završetka uvodnog razdoblja terapije nastavili su primati uvodnu terapiju, ovisno o podnošljivosti, ukoliko je njihovo opće stanje bilo zadovoljavajuće.
English: Ipilimumab is most commonly associated with adverse reactions resulting from increased or excessive immune activity.
Croatian: Ipilimumab je najčešće povezan s nuspojavama koje su posljedica pojačane ili pretjerane imunološke aktivnosti.
English: Severe adverse reactions in the endocrine glands, such as hypophysitis and thyroiditis that are not adequately controlled with hormone replacement therapy or high-dose immunosuppressive therapy
Croatian: Teške nuspojave koje zahvaćaju endokrine žlijezde, kao što su hipofizitis i tireoiditis, koje se ne mogu zadovoljavajuće kontrolirati zamjenskom hormonskom terapijom ili visokim dozama imunosupresivne terapije
English: STEP 1 Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes.
Croatian: 1. KORAK Ostavite odgovarajući broj bočica lijeka YERVOY da odstoje na sobnoj temperaturi približno 5 minuta.
English: A rare disease in which our immune system makes too many of otherwise normal infection fighting cells called histiocytes and lymphocytes.
Croatian: Rijetka bolest u kojoj imunološki sustav proizvodi previše stanica koje se u normalnom stanju bore protiv infekcija a zovu se histiociti i limfociti.
English: ≥ Grade 2 for immune-related eye disorders NOT responding to topical immunosuppressive therapy a
Croatian: ≥ imunološki uzrokovani poremećaji oka 2. stupnja koji NE odgovaraju na topikalnu imunosupresivnu terapiju a
English: The relationship of these malformations to treatment is unclear.
Croatian: Nije jasna povezanost tih anomalija s liječenjem.
English: Ipilimumab CL increased with increasing body weight and with increasing LDH at baseline; however, no dose adjustment is required for elevated LDH or body weight after administration on a mg/kg basis.
Croatian: Klirens ipilimumaba povećavao se s porastom početne tjelesne težine i vrijednosti LDH; međutim, nije potrebno prilagođavati dozu u slučaju povišenih vrijednosti LDH ili veće tjelesne težine kod liječenja dozom određenom na temelju tjelesne težine (mg/kg).
English: Administer the YERVOY infusion intravenously over a period of 30 or 90 minutes, depending on the dose.
Croatian: Infuziju lijeka YERVOY treba primijeniti intravenski tijekom razdoblja od 30 ili 90 minuta, ovisno o dozi.
English: Table 13:
Croatian: Tablica 13: