FrancophonIA/ELRC3.0 huggingface dataset:
English: To further investigate at post-approval the possible change in PD-L1 status of the tumour during treatment and/or tumour progression in Studies CA209-009, CA209-038 and CA209-064.
Croatian: Dodatno istražiti moguću promjenu PD-L1 statusa tumora tijekom liječenja i/ili progresiju tumora u ispitivanjima CA209-009,
English: These include: A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot) Abnormal liver function tests (increased amounts of the liver enzymes aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase in your blood, higher blood
Croatian: One smanjen broj crvenih krvnih stanica (koje prenose kisik), bijelih krvnih stanica (koje su važne za borbu protiv infekcija) ili krvnih pločica (stanica koje pomažu zgrušavanju krvi) odstupanja u nalazima testova jetrene funkcije (povećane količine jetrenih enzima aspartat aminotransferaze, alanin aminotransferaze ili alkalne fosfataze u krvi, povišene razine bilirubina odstupanja u nalazima testova bubrežne funkcije (povećane količine kreatinina u krvi) odstupanja u vrijednostima kalcija, kalija, magnezija ili natrija u krvi povišena razina enzima koji razgrađuje masnoće i enzima koji razgrađuje škrob
English: A total of 272 patients were randomised to receive either nivolumab 3 mg/kg (N = 135) administered intravenously over 60 minutes every 2 weeks or docetaxel (n = 137) 75 mg/m2 every 3 weeks.
Croatian: Ukupno su 272 bolesnika bila randomizirana u skupine koje su primale ili nivolumab u dozi od 3 mg/kg (N = 135), primijenjen intravenski tijekom 60 minuta svaka 2 tjedna, ili docetaksel (n = 137) u dozi od 75 mg/m2 svaka 3 tjedna.
English: Uncommon bronchitis, upper respiratory tract infection Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon histocytic necrotising lymphadenitis (Kikuchi lymphadenitis) Immune system disorders
Croatian: Manje često bronhitis, infekcija gornjih dišnih putova Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Manje često histiocitni nekrotizirajući limfadenitis (Kikuchijev limfadenitis) Poremećaji imunološkog sustava
English: Nivolumab is associated with immune-related adverse reactions.
Croatian: Nivolumab se povezuje s imunološki uzrokovanim nuspojavama.
English: However, once you are treated with Nivolumab BMS, your doctor may give you corticosteroids to reduce any possible side-effects that you may have during your treatment and this will not impact the effect of the medicine.
Croatian: Međutim, nakon što započnete liječenje lijekom Nivolumab BMS, liječnik će Vam možda dati kortikosteroide kako bi ublažio nuspojave koje bi mogle nastupiti tijekom liječenja, ali to
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza 'Rok valjanosti' ili 'EXP'.
English: Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Croatian: Nivolumab BMS indiciran je za liječenje lokalno uznapredovalog ili metastatskog planocelularnog raka pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) u odraslih osoba nakon
English: Nivolumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Croatian: Primjenu nivolumaba potrebno je odgoditi u slučaju osipa 3. stupnja te prekinuti u slučaju osipa 4. stupnja.
English: 10 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a grey flip-off seal (aluminium).
Croatian: 10 ml koncentrata u bočici od 10 ml (staklo tipa I) s čepom (obloženim butilnom gumom) i sivim flip-off zatvaračem (aluminij).
English: Nivolumab BMS should not be infused concomitantly in the same intravenous line with other medicinal products.
Croatian: Nivolumab BMS se ne smije infundirati istodobno s drugim lijekovima kroz istu intravensku liniju.
English: Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, pain in jaw, spinal pain.
Croatian: Mišićno-koštana bol je pojam koji uključuje bol u leđima, bol u kostima, mišićno koštanu bol u prsištu, nelagodu u mišićima i kostima, mialgiju, bol u vratu, bol u ekstremitetima, bol u čeljusti, bol u kralježnici.
English: What Nivolumab BMS contains
Croatian: Što Nivolumab BMS sadrži
English: Nivolumab BMS will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 60 minutes, every 2 weeks.
Croatian: Nivolumab BMS će se primjenjivati infuzijom (dripom) u venu (intravenski) tijekom razdoblja od 60 minuta svaka 2 tjedna.
English: 4 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a dark blue flip-off seal (aluminium).
Croatian: 4 ml koncentrata u bočici od 10 ml (staklo tipa I) s čepom (obloženim butilnom gumom) i tamnoplavim flip-off zatvaračem (aluminij).
English: In the pooled dataset of two studies in squamous NSCLC (CA209017 and CA209063), the most frequent adverse reactions (≥ 10% of patients) were fatigue (33%), decreased appetite (15%), and nausea (12%).
Croatian: U objedinjenim podacima iz dvaju ispitivanja provedenih u bolesnika sa planocelularnim NSCLC-om (CA209017 i CA209063), najčešće nuspojave (≥ 10% bolesnika) bile su umor (33%), smanjen tek (15%) i mučnina (12%).
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, diabetes mellitus, and diabetic ketoacidosis have been observed with nivolumab treatment.
Croatian: Kod liječenja nivolumabom primijećene su teške endokrinopatije, uključujući hipotireozu, hipertireozu, insuficijenciju nadbubrežne žlijezde, hipofizitis, dijabetes i dijabetičku ketoacidozu.
English: The effect of hepatic impairment on the CL of nivolumab was evaluated in patients with mild hepatic impairment (total bilirubin 1.0 × to 1.5 × ULN or AST > ULN as defined using the National Cancer Institute criteria of hepatic dysfunction; n = 92) compared to patients with normal hepatic function (total bilirubin and AST ≤ ULN; n = 804) in the population PK analyses.
Croatian: Učinak oštećenja jetrene funkcije na klirens nivolumaba ocjenjivao se u bolesnika s blagim oštećenjem jetrene funkcije (ukupni bilirubin 1,0 × do 1,5 × GGN ili AST > GGN, prema kriterijima za disfunkciju jetre Nacionalnog instituta za rak; n = 92) u usporedbi s bolesnicima s normalnom jetrenom funkcijom (ukupni bilirubin i AST ≤ GGN; n = 804) u populacijskim PK analizama.
English: The effects of Nivolumab BMS in pregnant women are not known, but it is possible that the active substance, nivolumab, could harm an unborn baby.
Croatian: Učinci lijeka Nivolumab BMS u trudnica nisu poznati, ali moguće je da djelatna tvar, nivolumab,
English: Prophylactic antibiotics should be used to prevent opportunistic infections in patients receiving immunosuppressive therapy.
Croatian: Bolesnicima koji primaju imunosupresivnu terapiju treba profilaktički davati antibiotike radi sprječavanja oportunističkih infekcija.
English: • Contact details of the Nivolumab BMS prescriber
Croatian: • Kontaktne podatke liječnika koji je propisao Nivolumab BMS
English: Monitoring of blood sugar should continue to ensure appropriate insulin replacement is utilised.
Croatian: Potrebno je nastaviti pratiti razinu šećera u krvi kako bi se osigurala primjena odgovarajuće inzulinske nadomjesne terapije.
English: Do not stop treatment with Nivolumab BMS unless you have discussed this with your doctor.
Croatian: Nemojte prekinuti liječenje lijekom Nivolumab BMS bez prethodnog razgovora sa svojim liječnikom.
English: The other ingredients are sodium citrate dihydrate, sodium chloride (see section 2 " Nivolumab BMS contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Croatian: Drugi sastojci su natrijev citrat dihidrat, natrijev klorid (pogledajte odlomak 'Nivolumab BMS sadrži natrij' u dijelu 2.), manitol (E421), pentetatna kiselina, polisorbat 80, natrijev hidroksid,
English: The study included patients (18 years or older) who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Croatian: U ispitivanje su bili uključeni bolesnici (u dobi od 18 ili više godina) koji su doživjeli progresiju bolesti tijekom ili nakon jednog prethodnog dvojnog kemoterapijskog protokola na bazi platine i koji su imali funkcionalni ECOG (engl.
English: Upon improvement, nivolumab may be resumed after corticosteroid taper, if needed.
Croatian: Nakon što nastupi poboljšanje, liječenje nivolumabom može se nastaviti nakon postupnog smanjivanja doze kortikosteroida, ako je to potrebno.
English: No clinically important differences in the CL of nivolumab were found between patients with mild hepatic impairment and normal hepatic function.
Croatian: Nisu primijećene klinički značajne razlike u klirensu nivolumaba između bolesnika s blagim oštećenjem jetrene funkcije i onih s normalnom jetrenom funkcijom.
English: Disease-related aetiologies should be ruled out.
Croatian: Potrebno je isključiti etiologiju povezanu s bolešću.
English: The patient will be provided with the Patient Alert Card with each prescription.
Croatian: Bolesnik će svaki put kada mu se propiše lijek dobiti i Karticu s upozorenjima za
English: Post-authorisation efficacy study (PAES): The MAH should submit an updated OS data for Study CA209017: a Phase 3, randomized study of nivolumab vs docetaxel in subjects with advanced or metastatic squamous NSCLC who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen.
Croatian: Ispitivanje djelotvornosti lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (engl. post-authorisation efficacy study, PAES): Nositelj odobrenja mora dostaviti ažurirane podatke o ukupnom preživljenju za ispitivanje CA209017: randomizirano ispitivanje faze 3, u kojem se nivolumab ocjenjivao naspram docetaksela u ispitanika s uznapredovalim ili metastatskim planocelularnim NSCLC-om koji su doživjeli progresiju bolesti tijekom ili nakon jednog prethodnog dvojnog kemoterapijskog
English: The recommended dose of Nivolumab BMS is 3 mg/kg administered intravenously over 60 minutes every 2 weeks.
Croatian: Preporučena doza lijeka Nivolumab BMS iznosi 3 mg/kg, a primjenjuje se intravenski tijekom 60 minuta svaka 2 tjedna.
English: Median time to onset was 11.6 weeks (range: 2.6-85.1).
Croatian: Medijan vremena do nastupa iznosio je 11,6 tjedana (raspon: 2,6-85,1).
English: Patients with a baseline performance score ≥ 2, active brain metastases or autoimmune disease, symptomatic interstitial lung disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the clinical trials of NSCLC (see sections 4.5 and 5.1).
Croatian: U klinička ispitivanja primjene kod NSCLC-a nisu bili uključeni bolesnici s početnim funkcionalnim statusom od ≥ 2, aktivnim metastazama u mozgu, autoimunom bolešću ili simptomatskom intersticijskom plućnom bolešću, kao ni bolesnici koji su prije uključivanja u ispitivanje primali sistemske imunosupresive (vidjeti dijelove 4.5 i 5.1).
English: Upon improvement, nivolumab may be resumed after corticosteroid taper.
Croatian: Nakon što nastupi poboljšanje, liječenje nivolumabom može se nastaviti nakon postupnog smanjivanja doze kortikosteroida.
English: Nivolumab has not been studied in patients with moderate (total bilirubin > 1.5 × to 3 × ULN and any AST) or severe hepatic impairment (total bilirubin > 3 × ULN and any AST) (see section 4.2).
Croatian: Nivolumab se nije ispitivao u bolesnika umjerenim (ukupni bilirubin > 1,5 × do 3 × GGN i bilo koja vrijednost AST-a) ili teškim oštećenjem jetrene funkcije (ukupni bilirubin > 3 × GGN i bilo koja vrijednost AST-a) (vidjeti dio 4.2).
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab treatment (see section 4.8).
Croatian: Kod liječenja nivolumabom primijećeni su teški pneumonitis ili intersticijska bolest pluća, uključujući slučajeve sa smrtnih ishodom (vidjeti dio 4.8).
English: What you need to know before you use Nivolumab BMS You should not be given Nivolumab BMS if you are allergic to nivolumab or any of the other ingredients of this medicine (listed in section 6 "Contents of the pack and other information").
Croatian: ako ste alergični na nivolumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6. 'Sadržaj pakiranja i druge informacije').
English: No Grade 3-5 cases were reported in these studies.
Croatian: U tim ispitivanjima nije prijavljen nijedan slučaj 3.-5. stupnja.
English: Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Croatian: Detaljne smjernice za zbrinjavanje imunološki uzrokovanih nuspojava opisane su u dijelu 4.4.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
Croatian: U slučaju predoziranja, bolesnike treba pažljivo pratiti zbog moguće pojave znakova ili simptoma nuspojava te odmah uvesti
English: Patients with active autoimmune disease, symptomatic interstitial lung disease, or untreated brain metastasis were excluded from the study.
Croatian: U ispitivanje nisu bili uključeni bolesnici s aktivnom autoimunom bolešću, simptomatskom intersticijskom plućnom bolešću ili neliječenim metastazama u mozgu.
English: Nivolumab BMS contains sodium
Croatian: Nivolumab BMS sadrži natrij
English: Administer the Nivolumab BMS infusion intravenously over a period of 60 minutes.
Croatian: Infuziju lijeka Nivolumab BMS primijenite intravenski tijekom razdoblja od 60 minuta.
English: Nivolumab BMS 10 mg/mL concentrate for solution for infusion nivolumab
Croatian: Nivolumab BMS 10 mg/ml koncentrat za otopinu za infuziju nivolumab
English: It is to be administered as an intravenous infusion over a period of 60 minutes.
Croatian: Primjenjuje se intravenskom infuzijom tijekom razdoblja od 60 minuta.
English: Data from patients with moderate or severe hepatic impairment are too limited to draw conclusions on these populations.
Croatian: Podaci o bolesnicima s umjerenim ili teškim oštećenjem jetrene funkcije su preoskudni da bi se mogli donijeti zaključci o primjeni u tim populacijama.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nivolumab BMS 10 mg/mL sterile concentrate nivolumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Nivolumab BMS 10 mg/ml sterilni koncentrat nivolumab i.v. primjena
English: Do not use Nivolumab BMS after the expiry date which is stated on the carton and on the vial label after EXP.
Croatian: Nivolumab BMS se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza 'Rok valjanosti' ili 'EXP'.
English: If immunosuppression with corticosteroids is used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Croatian: Ako se za liječenje nuspojave primjenjuje imunosupresija kortikosteroidima, nakon poboljšanja njihova se doza mora smanjivati postupno tijekom najmanje 1 mjeseca.
English: Increased lipase, increased amylase a
Croatian: Manje često povišene razine lipaze, povišene razine amilaze a
English: Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to increase foetal loss.
Croatian: Mišji modeli skotnosti pokazali su da blokiranje PD-L1 signalizacije smanjuje toleranciju na plod i povećava gubitak plodova.
English: Withhold Nivolumab BMS until symptoms resolve and management with corticosteroids (if needed for symptoms of acute inflammation) is complete.
Croatian: Odgoditi primjenu lijeka Nivolumab BMS dok se simptomi ne povuku i dok se ne završi liječenje kortikosteroidima (ako je ono potrebno za liječenje simptoma akutne upale).
English: Do not store any unused portion of the infusion solution for reuse.
Croatian: Neupotrijebljena otopina za infuziju ne smije se čuvati za kasniju ponovnu uporabu.
English: Grade 2 cases were reported in 3.6% (9/248) of patients.
Croatian: Slučajevi 2. stupnja prijavljeni su u 3,6% (9/248) bolesnika.
English: Nivolumab BMS must be administered with caution in patients with moderate (total bilirubin > 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin > 3 × ULN and any AST) hepatic impairment.
Croatian: Nivolumab BMS se mora primjenjivati uz oprez u bolesnika s umjerenim (ukupan bilirubin > 1,5 × do 3 × gornja granica normale [GGN] i bilo koja vrijednost AST-a) ili teškim (ukupan bilirubin > 3 × GGN i bilo koja vrijednost AST-a) oštećenjem jetrene funkcije.
English: To be taken into consideration when treating patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir u liječenju bolesnika
English: Patients with treated brain metastases were eligible if neurologically returned to baseline at least 2 weeks prior to enrolment, and either off corticosteroids, or on a stable or decreasing dose of <10 mg daily prednisone equivalents.
Croatian: Bolesnici s liječenim metastazama u mozgu mogli su sudjelovati ako su im se neurološki parametri vratili na početne vrijednosti najmanje 2 tjedna prije uključivanja u ispitivanje te ako su ili prestali primjenjivati kortikosteroide ili su primali stabilnu ili
English: o Immune-related nephritis or renal dysfunction
Croatian: Imunološki uzrokovan nefritis ili disfunkcija bubrega
English: Withhold Nivolumab BMS until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete
Croatian: Odgoditi primjenu lijeka Nivolumab BMS dok se simptomi ne povuku, dok se ne poboljšaju radiografske abnormalnosti i dok se ne dovrši liječenje kortikosteroidima
English: Each mL of concentrate for solution for infusion contains 10 mg of nivolumab.
Croatian: Jedan ml koncentrata za otopinu za infuziju sadrži 10 mg nivolumaba.
English: Resolution occurred in 5 patients (71%), including the Grade 3 case, with a median time to resolution of 5.9 weeks (range: 0.7- 37.6+); + denotes a censored observation.
Croatian: Nuspojave su se povukle u 5 bolesnika (71%), uključujući bolesnika sa slučajem 3. stupnja, a medijan vremena do njihova povlačenja iznosio je 5,9 tjedana (raspon: 0,7-37,6+); + označava cenzurirano opažanje.
English: Very common increased AST,bincreased ALT,b increased alkaline phosphatase,b increased creatinine,b decreased lymphocytes,b decreased platelet count,b decreased haemoglobin,b hypercalcaemia,b hypocalcaemia,b hyperkalaemia,b hypokalaemia,b hypomagnesaemia,b hyponatraemiab
Croatian: Manje često anafilaktička reakcija, preosjetljivost, reakcija povezana s infuzijom Endokrini poremećaji proljev, stomatitis, povraćanje, bol u abdomenu, konstipacija, suha usta b, povišene razine ALT-a b, povišene razine alkalne b, smanjen broj limfocita b, smanjen broj b, hiperkalcijemija b, hipokalcijemija b,
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove
English: There was a dose-dependent increase in foetal losses and increased neonatal mortality beginning in the third trimester.
Croatian: Od trećeg je tromjesečja primijećeno o dozi ovisno povećanje gubitka plodova te povećana neonatalna smrtnost.
English: You must use effective contraception while you are being treated with Nivolumab BMS and for at least 5 months following the last dose of Nivolumab BMS, if you are a woman who could
Croatian: Ako postoji mogućnost da zatrudnite, morate koristiti učinkovitu kontracepciju dok se liječite lijekom Nivolumab BMS i još najmanje 5 mjeseci nakon posljednje doze lijeka Nivolumab
English: Based on the severity of the adverse reaction, nivolumab should be withheld and corticosteroids administered.
Croatian: Ovisno o težini nuspojave, potrebno je odgoditi primjenu nivolumaba i primijeniti kortikosteroide.
English: Patients should be monitored for diarrhoea and additional symptoms of colitis, such as abdominal pain and mucus or blood in stool.
Croatian: Bolesnike treba pratiti zbog mogućeg nastupa proljeva i dodatnih simptoma kolitisa, poput boli u abdomenu te sluzi ili krvi u stolici.
English: Baseline ECOG performance status score was 0 (24%) or
Croatian: Početni opći ECOG status iznosio je 0 (24%) ili 1 (76%).
English: Nivolumab BMS infusion must not be administered as an intravenous push or bolus injection.
Croatian: Infuzija lijeka Nivolumab BMS ne smije se primijeniti brzom niti bolusnom intravenskom injekcijom.
English: Resolution occurred in 24 patients (83%), including the 2 patients with a Grade 3 case, with a median time to resolution of 5.7 weeks (range: 0.1- 46.9+); + denotes a censored observation.
Croatian: Nuspojave su se povukle u 24 bolesnika (83%), uključujući 2 bolesnika sa slučajem 3. stupnja, a medijan vremena do njihova povlačenja iznosio je 5,7 tjedana (raspon: 0,1-46,9+); + označava cenzurirano opažanje.
English: The geometric mean clearance (CL), terminal half-life, and average exposure at steady state at 3 mg/kg every 2 weeks of nivolumab were 9.5 mL/h, 26.7 days, and 75.3 µg/mL, respectively, based on a population PK analysis.
Croatian: Na temelju populacijske PK analize, utvrđeno je da je geometrijska srednja vrijednost klirensa nivolumaba iznosila 9,5 ml/h, a terminalni poluvijek 26,7 dana, dok je prosječna izloženost u stanju dinamičke ravnoteže nakon primjene doze od 3 mg/kg svaka 2 tjedna iznosila 75,3 µg/ml.
English: Nivolumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-related adverse reaction.
Croatian: Liječenje nivolumabom mora se trajno prekinuti ako se bilo koja od teških imunološki uzrokovanih nuspojava povrati i ako nastupi bilo koja imunološki uzrokovana nuspojava opasna po život.
English: Permanently discontinue Nivolumab BMS Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
Croatian: Napomena: Stupnjevi toksičnosti u skladu su s verzijom 4.0 Zajedničkih terminoloških kriterija za nuspojave
English: Median time to onset was 25.1 weeks (range: 4.1-31.1).
Croatian: Medijan vremena do nastupa iznosio je 25,1 tjedan (raspon: 4,1-31,1).
English: Median time to onset was 8.1 weeks (range: 0.3-51.9).
Croatian: Medijan vremena do nastupa iznosio je 8,1 tjedan (raspon: 0,3-51,9).
English: Median time to onset was 10.5 weeks (range: 2.1-27.0).
Croatian: Medijan vremena do nastupa iznosio je 10,5 tjedana (raspon: 2,1-27,0).
English: The management guidelines for these adverse reactions are described in section 4.4.
Croatian: Smjernice za zbrinjavanje tih nuspojava opisane su u dijelu 4.4.
English: No Grade 4 or 5 nephritis or renal dysfunction was reported in these studies.
Croatian: U tim ispitivanjima nije prijavljen nijedan slučaj nefritisa ni bubrežne disfunkcije 4. ili 5. stupnja.
English: Monitoring of pituitary function and hormone levels should continue to ensure appropriate hormone replacement is utilised.
Croatian: Potrebno je nastaviti pratiti funkciju hipofize i razine hormona kako bi se osigurala primjena odgovarajuće hormonske nadomjesne terapije.
English: Clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Croatian: Bistra do opalescentna, bezbojna do blijedožuta tekućina koja može sadržavati malu količinu sitnih čestica.
English: Nivolumab BMS must not be administered as an intravenous push or bolus injection.
Croatian: Nivolumab BMS se ne smije primijeniti brzom niti bolusnom intravenskom injekcijom.
English: The value of biomarkers to predict the efficacy of nivolumab should be further explored, specifically:
Croatian: Potrebno je dodatno istražiti vrijednost bioloških biljega u predviđanju