FrancophonIA/ELRC3.0 huggingface dataset:
English: In study CA209017, hypercalcaemia was more frequently reported in the nivolumab group (31/130, 24%) than in the docetaxel group (9/124, 7%).
Croatian: U ispitivanju CA209017, hiperkalcijemija je prijavljena češće u skupini liječenoj nivolumabom (31/130, 24%) nego u onoj koja je primala docetaksel (9/124, 7%).
English: Rapid tapering may lead to worsening of the adverse reaction.
Croatian: Naglo smanjenje doze može dovesti do pogoršanja nuspojave.
English: Data from patients 75 years of age or older are too limited to draw conclusions on this population.
Croatian: Podaci o bolesnicima u dobi od 75 ili više godina su preoskudni da bi se mogli donijeti zaključci o primjeni u toj populaciji.
English: Each vial contains either 40 mg (in 4 mL) or 100 mg (in 10 mL) of nivolumab.
Croatian: Jedna bočica sadrži ili 40 mg (u 4 ml) ili 100 mg (u 10 ml) nivolumaba.
English: However, systemic corticosteroids and other immunosuppressants can be used after starting nivolumab to treat immune-related adverse reactions.
Croatian: Međutim, sistemski kortikosteroidi i drugi imunosupresivi mogu se koristiti nakon uvođenja nivolumaba za liječenje imunološki uzrokovanih nuspojava.
English: Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion.
Croatian: Vezanje PD-1 s ligandima PD-L1 i PD-L2, koji su eksprimirani u antigen prezentirajućim stanicama i mogu biti eksprimirani na tumorskim stanicama ili drugim stanicama u mikrookolini tumora, dovodi do inhibicije proliferacije T-stanica i lučenja citokina.
English: Nivolumab BMS infusion must be completed within 24 hours of preparation.
Croatian: Infuzija lijeka Nivolumab BMS mora se dovršiti unutar 24 sata nakon pripreme.
English: Do not take any other medicines during your treatment without talking to your doctor first.
Croatian: Nemojte uzimati nijedan drugi lijek tijekom liječenja ako o tome niste prethodno razgovarali sa svojim
English: For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes.
Croatian: U slučaju sumnje na imunološki uzrokovane nuspojave, treba napraviti odgovarajuću procjenu kako bi se potvrdila etiologija ili isključili drugi uzroci.
English: For storage conditions after preparation of the infusion, see section 6.3.
Croatian: Uvjete čuvanja nakon pripreme infuzije vidjeti u dijelu 6.3.
English: In case of a severe infusion reaction, nivolumab infusion must be discontinued and appropriate medical therapy administered.
Croatian: U slučaju teške reakcije na infuziju, mora se prekinuti infuzija nivolumaba i primijeniti odgovarajuća medicinska terapija.
English: Grade 3 or 4 pneumonitis
Croatian: Pneumonitis 3. ili 4. stupnja
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies and for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation).
Croatian: Bolesnike je potrebno pratiti zbog moguće pojave znakova i simptoma endokrinopatija te mogućih promjena u funkciji štitnjače (na početku liječenja, periodički tijekom liječenja te prema potrebi na temelju kliničke procjene).
English: Calculating the dose
Croatian: Izračun doze
English: To further investigate the value biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other methods / assays, and associated cut-offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1, PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, etc.) as predictive of nivolumab efficacy.
Croatian: Dodatno istražiti vrijednost drugih bioloških biljega osim statusa imunohistokemijom (npr. druge metode/testove i pridružene granične vrijednosti, koje bi se mogle pokazati osjetljivijima i specifičnijima u predviđanju odgovora na liječenje na temelju PD-L1, PD-L2, limfocita koji infiltriraju tumore uz određivanje gustoće CD8+ T-stanica, RNK potpisa itd.) kao pretkazatelja djelotvornosti nivolumaba.
English: The volume of Nivolumab BMS concentrate to prepare the dose (mL) = the total dose in mg, divided by 10 (the Nivolumab BMS concentrate strength is 10 mg/mL).
Croatian: Volumen koncentrata lijeka Nivolumab BMS za pripremu doze (ml) = ukupna doza u mg, podijeljena s 10 (jačina koncentrata lijeka Nivolumab BMS iznosi 10 mg/ml).
English: 31st December 2017 30th September 2017
Croatian: 31. prosinca 2017. 30. rujna 2017.
English: The Grade 3 case required permanent discontinuation of nivolumab.
Croatian: Slučaj 3. stupnja zahtijevao je trajan prekid liječenja nivolumabom.
English: In CA209017 and CA209063, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 13.2% for decreased lymphocytes, 9% for hyponatraemia, 2.9% for hypercalcaemia and hyperkalaemia, 2.5% for decreased haemoglobin (all Grade 3), 2.0% for hypokalaemia, 1.6% for decreased neutrophil count, 1.3% for hypomagnesaemia, 1.2% for hypocalcaemia, 0.8% for increased total bilirubin, and 0.4% for increased AST, decreased platelet, hypermagnesaemia, and hypernatraemia.
Croatian: U ispitivanjima CA209017 i CA209063, udio bolesnika kod kojih je došlo do odstupanja 3. ili 4. stupnja od početnih laboratorijskih vrijednosti bio je sljedeći: 13,2% za smanjen broj limfocita, 9% za hiponatrijemiju, 2,9% za hiperkalcijemiju i hiperkalijemiju, 2,5% za smanjenu razinu hemoglobina (svi slučajevi bili su 3. stupnja), 2,0% za hipokalijemiju, 1,6% za smanjen broj neutrofila, 1,3% za hipomagnezijemiju, 1,2% za hipokalcijemiju, 0,8% za povišene razine ukupnog bilirubina te 0,4% za povišene razine ALT-a, smanjen broj trombocita, hipermagnezijemiju i hipernatrijemiju.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA
English: Studies to evaluate the effect of nivolumab on fertility have not been performed.
Croatian: Nisu provedena ispitivanja kojima bi se ocijenio učinak nivolumaba na plodnost.
English: The effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis in the first trimester through delivery, at exposure levels either 8 or 35 times higher than those observed at the clinical dose of 3 mg/kg of nivolumab (based on AUC).
Croatian: Učinci nivolumaba na prenatalni i postnatalni razvoj ocjenjivali su se u ženki majmuna koje su primale nivolumab dvaput tjedno od početka organogeneze u prvom tromjesečju do okota, uz razine izloženosti koje su bile 8 ili 35 puta veće od onih primijećenih nakon primjene kliničke doze nivolumaba od 3 mg/kg (na temelju AUC-a).
English: Caution should be used when considering the use of nivolumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immunestimulatory anticancer agents.
Croatian: Potreban je oprez kada se primjena nivolumaba razmatra u bolesnika koji su već doživjeli tešku ili po život opasnu nuspojavu na koži tijekom prethodnog liječenja drugim lijekovima za liječenje raka koji stimuliraju imunosni sustav.
English: Problems with your hormone producing glands (including the pituitary, the thyroid and adrenal glands) that may affect how these glands work.
Croatian: tegobe sa žlijezdama koje proizvode hormone (uključujući hipofizu, štitnjaču i nadbubrežne žlijezde), koje mogu utjecati na rad tih žlijezda.
English: 4.2 Posology and method of administration Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Croatian: Liječenje moraju započeti i nadzirati liječnici s iskustvom u liječenju raka.
English: There were no reports of hypophysitis, diabetes mellitus, or diabetic ketoacidosis in these studies.
Croatian: U tim ispitivanjima nisu prijavljeni slučajevi hipofizitisa, dijabetesa ni dijabetičke ketoacidoze.
English: Nivolumab showed numerically less effect on OS (HR 1.85; 95% CI: 0.76, 4.51), PFS (HR=1.76; 95%-CI: 0.77, 4.05 ) and ORR (9.1% vs 16.7%).
Croatian: Nivolumab je pokazao brojčano manji učinak na OS (omjer hazarda, HR 1,85; 95% CI: 0,76; 4,51), PFS (HR=1,76; 95% CI: 0,77; 4,05) i ORR (9,1% naspram 16,7%).
English: Patients should be monitored for signs and symptoms of hepatitis such as transaminase and total bilirubin elevations.
Croatian: Bolesnike treba pratiti zbog moguće pojave znakova i simptoma hepatitisa, poput povišenih razina transaminaza i ukupnog bilirubina.
English: Median time to onset of these endocrinopathies was 17.8 weeks (range: 6.1-33.1).
Croatian: Medijan vremena do nastupa tih endokrinopatija iznosio je 17,8 tjedana (raspon: 6,1-33,1).
English: Nivolumab BMS should also be permanently discontinued for Grade 2 or 3 immune-related adverse reactions that persist despite treatment modifications (see section 4.4) or for inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day.
Croatian: Liječenje lijekom Nivolumab BMS potrebno je trajno prekinuti i u slučaju imunološki uzrokovanih nuspojava 2. ili 3. stupnja koje ne prolaze unatoč modifikacijama liječenja (vidjeti dio 4.4) ili u slučaju nemogućnosti smanjenja doze kortikosteroida na 10 mg prednizona ili ekvivalenta na dan.
English: Do not shake the vial.
Croatian: Nemojte tresti bočicu.
English: Very common (may affect more than 1 in 10 people) Decreased appetite
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) smanjen tek mučnina umor ili slabost
English: Of the 497 patients who were treated with nivolumab 3 mg/kg every 2 weeks and evaluable for the presence of anti-product-antibodies, 51 (10.3%) patients tested positive for treatment-emergent anti-product antibodies by an electrochemiluminescent (ECL) assay.
Croatian: Među 497 bolesnika liječenih nivolumabom u dozi od 3 mg/kg svaka 2 tjedna u kojih se mogla odrediti prisutnost protutijela na lijek, njih je 51 (10,3%) bilo pozitivno na protutijela na lijek koja su se razvila tijekom liječenja, što je utvrđeno testom elektrokemiluminiscencije (engl. electrochemiluminescence, ECL).
English: Withdraw the required volume of Nivolumab BMS concentrate using an appropriate sterile
Croatian: Izvucite potreban volumen koncentrata lijeka Nivolumab BMS odgovarajućom sterilnom
English: Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease.
Croatian: U bolesnika se mogu javiti umor, glavobolja, promjene mentalnog statusa, bol u abdomenu, neuobičajena aktivnost crijeva i hipotenzija, ili nespecifični simptomi koji mogu nalikovati drugim uzrocima, poput metastaza u mozgu ili podležeće bolesti.
English: Study CA209063 was a single-arm, open-label study conducted in 117 patients with locally advanced or metastatic squamous-NSCLC after two or more lines of therapy; otherwise similar inclusion criteria as study CA209017 were applied.
Croatian: Ispitivanje CA209063 bilo je otvoreno ispitivanje sa samo jednom skupinom provedeno u 117 bolesnika s lokalno uznapredovalim ili metastatskim planocelularmim NSCLC-om nakon dvije ili više linija liječenja; osim toga, uključni kriteriji bili su slični onima koji su se koristili u ispitivanju CA209017.
English: Patients treated with Nivolumab BMS must be given the patient alert card and be informed about the risks of Nivolumab BMS (see also package leaflet).
Croatian: Bolesnicima koji se liječe lijekom Nivolumab BMS mora se dati Kartica s upozorenjima za bolesnika te ih se mora upozoriti na rizike liječenja lijekom Nivolumab BMS (vidjeti i Uputu o lijeku).
English: Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
Croatian: Nivolumab potencira odgovore T-stanica, uključujući protutumorske odgovore, tako što blokira vezanje PD-1 za ligande PD-L1 i PD-L2.
English: Human IgG4 is known to cross the placental barrier and nivolumab is an IgG4; therefore nivolumab has the potential to be transmitted from the mother to the
Croatian: Poznato je da ljudski IgG4 prolazi placentalnu barijeru, a nivolumab je IgG4.
English: It is very important for you to keep all your appointments to receive Nivolumab BMS.
Croatian: Vrlo je važno da dolazite na sve dogovorene termine za primjenu lijeka Nivolumab BMS.
English: In the phase 1 study MDX1106-03, pneumonitis, including a Grade 4 case in 1 patient, was reported in 3/37 patients (8.1%) with NSCLC receiving nivolumab 3 mg/kg.
Croatian: U ispitivanju faze 1 MDX1106-03, pneumonitis je prijavljen je u 3/37 bolesnika (8,1%) s NSCLC-om koji su primali nivolumab u dozi od 3 mg/kg, uključujući jedan slučaj 4. stupnja
English: Nivolumab 3 mg/kg (events : 86/135), median and 95% CI : 9.23 (7.33, 13.27)
Croatian: Nivolumab 3 mg/kg (događaji: 86/135), medijan i 95% CI: 9,23 (7,33; 13,27)
English: The Adverse Reaction Management Guide shall contain the following key elements:
Croatian: Vodič za zbrinjavanje nuspojava sadržavat će sljedeće ključne elemente:
English: Recommended treatment modifications for Nivolumab BMS
Croatian: Preporučene modifikacije liječenja lijekom Nivolumab BMS
English: Frequencies reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements.
Croatian: Učestalosti odražavaju udio bolesnika u kojih je došlo do pogoršanja laboratorijskih parametara u odnosu na početne vrijednosti.
English: Excipients: sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Croatian: Pomoćne tvari: natrijev citrat dihidrat, natrijev klorid, manitol (E421), pentetatna kiselina, polisorbat 80, natrijev hidroksid, kloridna kiselina, voda za injekcije.
English: Systemic immunosuppression
Croatian: Sistemska imunosupresija
English: Signs and symptoms may include abnormal kidney function tests, or decreased volume of urine.
Croatian: Znakovi i simptomi mogu uključivati odstupanja u nalazima testova bubrežne funkcije ili smanjen volumen mokraće.
English: Nivolumab BMS is for intravenous use only.
Croatian: Nivolumab BMS je namijenjen samo za intravensku primjenu.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: A decision must be made whether to discontinue breast-feeding or to discontinue from nivolumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti hoće li se prekinuti dojenje ili liječenje nivolumabom uzimajući u obzir korist
English: 30th September 2017
Croatian: 30. rujna 2017.
English: The infusion should be prepared in a laminar flow hood or safety cabinet using standard precautions for the safe handling of intravenous agents.
Croatian: Infuziju treba pripremiti u komori s laminarnim protokom ili zaštitnom kabinetu pridržavajući se standardnih mjera opreza za sigurno
English: The following side effects have been reported in clinical trials with nivolumab:
Croatian: U kliničkim ispitivanjima nivolumaba prijavljene su sljedeće nuspojave:
English: No Grade 3-5 thyroid disorders were reported.
Croatian: Nije prijavljen nijedan poremećaj štitnjače 3.-5. stupnja.
English: Signs and symptoms of hepatitis may include abnormal liver function tests, eye or skin yellowing (jaundice), pain on the right side of your stomach area, or tiredness.
Croatian: Znakovi i simptomi hepatitisa mogu uključivati odstupanja u nalazima testova jetrene funkcije, žutu boju očiju ili kože (žutica), bol u desnoj strani trbuha ili umor. upalu bubrega ili bubrežne tegobe.
English: The incidence of adrenal insufficiency was 0.4% (1/248; Grade 3).
Croatian: Incidencija insuficijencije nadbubrežne žlijezde iznosila je 0,4% (1/248; 3. stupanj).
English: Patients should be monitored for signs and symptoms of nephritis and renal dysfunction.
Croatian: Bolesnike treba pratiti zbog moguće pojave znakova i simptoma nefritisa i bubrežne disfunkcije.
English: Data for the following immune-related adverse reactions are based on patients who received nivolumab 3 mg/kg in two NSCLC studies (CA209017 and CA209063, see section 5.1).
Croatian: Podaci za sljedeće imunološki uzrokovane nuspojave temelje se na bolesnicima koji su primali nivolumab u dozi od 3 mg/kg u dvama ispitivanjima u bolesnika oboljelih od NSCLC-a (CA209017 i CA209063, vidjeti dio 5.1).
English: Nivolumab BMS should be continued in the presence of hormone replacement therapy a as long as no symptoms are present
Croatian: Liječenje lijekom Nivolumab BMS treba nastaviti uz hormonsku nadomjesnu a, pod uvjetom da nema nikakvih terapiju simptoma
English: The following immune-related adverse reactions were reported in less than 1% of patients treated with nivolumab in clinical trials across doses and tumour types: pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barré syndrome, hypopituitarism, and myasthenic syndrome.
Croatian: Sljedeće imunološki uzrokovane nuspojave prijavljene su u manje od 1% bolesnika koji su u kliničkim ispitivanjima primali različite doze nivolumaba za liječenje različitih vrsta tumora: pankreatitis, uveitis, demijelinizacija, autoimuna neuropatija (uključujući parezu ličnog živca i živca odmicača oka), Guillain-Barréov sindrom, hipopituitarizam i mijastenički sindrom.
English: Treatment was continued as long as clinical benefit was observed or until treatment was no longer tolerated.
Croatian: Liječenje se nastavilo sve dok je bilo kliničke koristi ili do trenutka kada bolesnik više nije mogao podnositi liječenje.
English: If not used immediately, chemical and physical in-use stability of Nivolumab BMS has been demonstrated for 24 hours at 2ºC to 8ºC protected from light and a maximum of 4 hours at 20°C-25°C and room light (this 4-hour period of the total 24 hours should be inclusive of the product administration period).
Croatian: Ako se ne upotrijebi odmah, kemijska i fizička stabilnost lijeka Nivolumab BMS dokazana je tijekom 24 sata ako se čuva na temperaturi od 2°C-8°C zaštićen od svjetlosti, te tijekom najviše 4 sata na temperaturi od 20°C-25°C i sobnoj svjetlosti (ovo 4-satno razdoblje od ukupnog 24-satnog razdoblja
English: It is not known whether nivolumab gets into breast milk.
Croatian: Nije poznato izlučuje li se nivolumab u majčino mlijeko.
English: Severe hepatitis has been observed with nivolumab treatment.
Croatian: Kod liječenja nivolumabom primijećen je težak hepatitis.
English: Nivolumab 3 mg/kg showed an overall response rate of 14.5% (95% CI: 8.7-22.2%), a median OS of 8.21 months (95% CI: 6.05-10.9 months ), and a median PFS of 1.87 months (95% CI 1.77-3.15 months.
Croatian: Nivolumab u dozi od 3 mg/kg ostvario je stopu ukupnog odgovora od 14,5% (95% CI: 8,7-22,2%), medijan OS-a od 8,21 mjeseca (95% CI: 6,05-10,9 mjeseci) i medijan PFS-a od 1,87 mjeseci (95% CI: 1,77-3,15 mjeseci).
English: Nivolumab BMS can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting to concentrations as low as 1 mg/mL.
Croatian: Nivolumab BMS se može upotrijebiti za intravensku primjenu: bez razrjeđivanja, nakon prijenosa u infuzijski spremnik uz pomoć odgovarajuće sterilne nakon razrjeđivanja do niskih koncentracija od čak 1 mg/ml.
English: The effect of renal impairment on the CL of nivolumab was evaluated in patients with mild (GFR < 90 and ≥ 60 mL/min/1.73 m2; n = 379), moderate (GFR < 60 and ≥ 30 mL/min/1.73 m2; n = 179), or severe (GFR < 30 and ≥ 15 mL/min/1.73 m2; n = 2) renal impairment compared to patients with normal renal function (GFR ≥ 90 mL/min/1.73 m2; n = 342) in population PK analyses.
Croatian: Učinak oštećenja bubrežne funkcije na klirens nivolumaba ocjenjivao se u bolesnika s blagim (GFR < 90 i ≥ 60 ml/min/1,73 m2; n = 379), umjerenim (GFR < 60 i ≥ 30 ml/min/1,73 m2; n = 179) ili teškim (GFR < 30 i ≥ 15 ml/min/1,73 m2; n = 2) oštećenjem bubrežne funkcije u usporedbi s bolesnicima s normalnom bubrežnom funkcijom (GFR ≥ 90 ml/min/1,73 m2; n = 342) u populacijskim
English: One patient required permanent discontinuation of nivolumab due to Grade 2 increases in transaminases.
Croatian: U jednog se bolesnika liječenje nivolumabom moralo trajno prekinuti zbog povišenja razine transaminaza 2. stupnja.
English: Randomised phase 3 study vs. docetaxel (CA209017)
Croatian: Randomizirano ispitivanje faze 3 naspram docetaksela (CA209017)
English: The total nivolumab dose in mg = the patient's weight in kg × the prescribed dose in mg/kg.
Croatian: Ukupna doza nivolumaba u mg = bolesnikova tjelesna težina u kg × propisana doza u mg/kg.
English: Patients should be monitored for signs and symptoms of pneumonitis such as radiographic changes (e.g., focal ground glass opacities, patchy filtrates), dyspnoea, and hypoxia.
Croatian: Bolesnike treba pratiti zbog moguće pojave znakova i simptoma pneumonitisa, poput radiografskih promjena (npr. fokalnih zasjenjenja nalik na mliječno staklo, mrljastih infiltrata), dispneje i hipoksije.
English: Nivolumab BMS infusion is compatible with PVC and polyolefin containers, glass bottles, PVC infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Croatian: Infuzija lijeka Nivolumab BMS kompatibilna je sa spremnicima od PVC-a i poliolefina, staklenim bocama, infuzijskim kompletima od PVC-a i in-line filtrima koji imaju polietersulfonske membrane s veličinom pora od 0,2 µm do 1,2 µm.
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced or metastatic squamous NSCLC were evaluated in a phase 3, randomised, open-label study (CA209017).
Croatian: Sigurnost i djelotvornost nivolumaba u dozi od 3 mg/kg kao monoterapije za liječenje uznapredovalog ili metastatskog planocelularnog NSCLC-a ispitivane su u randomiziranom, otvorenom ispitivanju faze 3 (CA209017).
English: Based on the population PK results, no dose adjustment is required in patients with mild hepatic impairment (see section 5.2).
Croatian: Na temelju rezultata populacijske PK analize nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem jetrene funkcije (vidjeti dio 5.2).
English: Nivolumab is most commonly associated with immune-related adverse reactions.
Croatian: Nivolumab se najčešće povezuje s imunološki uzrokovanim nuspojavama.
English: Efficacy results (CA209017)
Croatian: Tablica 3: Rezultati za djelotvornost (CA209017) nivolumab
English: Table 2: Adverse reactions in patients with squamous NSCLC treated with nivolumab 3 mg/kg (CA209017 and CA209063)
Croatian: Tablica 2: Nuspojave u bolesnika s planocelularnim NSCLC-om liječenih nivolumabom u dozi od 3 mg/kg (CA209017 i CA209063)
English: Each mL of this medicinal product contains 0.1 mmol (or 2.5 mg) sodium.
Croatian: Jedan ml ovog lijeka sadrži 0,1 mmol (ili 2,5 mg) natrija.
English: Severe infusion reactions have been reported in clinical trials (see section 4.8).
Croatian: U kliničkim su ispitivanjima prijavljene teške reakcije na infuziju (vidjeti dio 4.8).
English: The prescriber must discuss the risks of Nivolumab BMS therapy with the patient.
Croatian: Liječnik koji propisuje lijek mora s bolesnikom razgovarati o rizicima liječenja lijekom Nivolumab BMS.
English: Based on the population pharmacokinetic (PK) results, no dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Croatian: Na temelju rezultata populacijske farmakokinetičke (PK) analize nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije (vidjeti dio 5.2).