FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no evidence of altered pharmacokinetic or toxicity profile associated with anti-product-antibody development.
Slovenian: V povezavi z razvojem protiteles proti zdravilu niso ugotovili znakov spremenjenega farmakokinetičnega profila ali profila toksičnosti.
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.
Slovenian: statusa tumorja med zdravljenjem in/ali napredovanjem tumorja v študijah CA209-009, CA209-038 in CA209-064.
English: For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes.
Slovenian: V primeru suma na pojav imunsko pogojenih neželenih učinkov je treba z ustreznimi preiskavami potrditi njihov vzrok oziroma izključiti druge možne vzroke.
English: Each mL of this medicinal product contains 0.1 mmol (or 2.5 mg) sodium.
Slovenian: En ml tega zdravila vsebuje 0,1 mmol (ali 2,5 mg) natrija.
English: Tel: + 39 06 50 39 61
Slovenian: Tel: + 39 06 50 39 61 Nederland
English: Data from patients 75 years of age or older are too limited to draw conclusions on this population.
Slovenian: Pri bolnikih, starih 75 let ali starejših, je na voljo premalo podatkov, zato zaključkov za to populacijo ne moremo navesti.
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.
Slovenian: Zdravilo Nivolumab BMS je indicirano za zdravljenje lokalno napredovalega ali metastatskega ploščatoceličnega nedrobnoceličnega pljučnega raka (NSCLC - non-small cell lung cancer) po
English: Patients with mild or moderate infusion reaction may receive nivolumab with close monitoring.
Slovenian: Bolniki z blago ali zmerno infuzijsko reakcijo se z nivolumabom lahko zdravijo, vendar pa jih je med infundiranjem treba skrbno nadzirati.
English: For storage conditions after preparation of the infusion, see section 6.3.
Slovenian: Za pogoje shranjevanja po pripravi raztopine za infundiranje glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: Stopping your treatment may stop the effect of the medicine.
Slovenian: Ta zdravila lahko vplivajo na učinek zdravila
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), monoklonska
English: Infectious and disease-related aetiologies should be ruled out.
Slovenian: Izključiti je treba okužbe in vzroke, povezane z boleznijo.
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
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) občasni histiocitni nekrotizirajoči limfadenitis (Kikuchijev limfadenitis)
English: Body weight normalised dosing produced approximately uniform steady-state trough concentration over a wide range of body weights (34-162 kg).
Slovenian: Z uporabo na telesno maso prilagojenih odmerkov zagotovimo približno enakomerno najmanjšo koncentracijo v stanju dinamičnega ravnovesja pri širokem razponu telesnih mas (od 34 do 162 kg).
English: Prophylactic antibiotics should be used to prevent opportunistic infections in patients receiving immunosuppressive therapy.
Slovenian: Pri bolnikih, ki se zdravijo z zdravili za zaviranje imunske odzivnosti, je treba profilaktično uporabljati antibiotike za preprečevanje oportunističnih okužb.
English: Median time to onset was 11.6 weeks (range: 2.6-85.1).
Slovenian: Mediani čas do pojava je znašal 11,6 tednov (razpon: 2,6-85,1).
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).
Slovenian: Opomba: Stopnje toksičnosti so navedene v skladu z različico 4.0 terminološko poenotenih kriterijev neželenih učinkov ameriškega Nacionalnega onkološkega inštituta (NCI-CTCAE v4; “National Cancer Institute
English: Withhold Nivolumab BMS until symptoms resolve and management with corticosteroids (if needed for symptoms of acute inflammation) is complete.
Slovenian: Aplikacijo zdravila Nivolumab BMS zadržite dokler simptomi ne izzvenijo in zdravljenje s kortikosteroidi (če je bilo potrebno za zdravljenje simptomov akutnega vnetja) ni končano.
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.
Slovenian: Pri uporabi nivolumaba v odmerku 3 mg/kg je delež celokupnega odziva znašal 14,5 % (95 % interval zaupanja: 8,7-22,2 %), mediana celokupnega preživetja 8,21 meseca (95 % interval zaupanja: 6,05-10,9 meseca), mediana preživetja brez napredovanja bolezni pa 1,87 meseca (95 % interval zaupanja: 1,77-3,15 meseca.
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.
Slovenian: Nivolumab BMS vsebuje natrij”), manitol (E421), pentetska kislina, polisorbat 80, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
English: Severe infusion reactions have been reported in clinical trials (see section 4.8).
Slovenian: V kliničnih preskušanjih so poročali o pojavu hudih infuzijskih reakcij (glejte poglavje 4.8).
English: Severe hepatitis has been observed with nivolumab treatment.
Slovenian: Pri zdravljenju z nivolumabom so poročali o hudem hepatitisu.
English: Patients should be monitored for diarrhoea and additional symptoms of colitis, such as abdominal pain and mucus or blood in stool.
Slovenian: Bolnike je treba nadzirati glede pojava driske in dodatnih simptomov kolitisa, kot so bolečina v trebuhu in sluz ali kri v blatu.
English: Take care to ensure aseptic handling when you prepare the infusion.
Slovenian: Pri pripravi raztopine za infundiranje morate zagotoviti aseptične pogoje.
English: Nivolumab BMS infusion is compatible with: PVC containers
Slovenian: Nivolumab BMS raztopina za infundiranje je kompatibilna z vsebniki iz PVC-ja in poliolefina,
English: There was no worsening to Grade 3 or 4 in increased ALT, increased alkaline phosphatase, and increased creatinine.
Slovenian: O zvišanju vrednosti ALT, zvišanju vrednosti alkalne fosfataze in zvišanju vrednosti kreatinina stopnje 3 ali 4 niso poročali.
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.
Slovenian: Vpliv okvare jeter na očistek nivolumaba so v analizah populacijske farmakokinetike ovrednotili pri bolnikih z blago okvaro jeter (skupni bilirubin 1,0 × do 1,5 × ZMN ali AST > ZMN po kriterijih ameriškega Nacionalnega onkološkega inštituta za disfunkcijo jeter; n = 92) v primerjavi z bolniki z normalnim delovanjem jeter (skupni bilirubin in AST ≤ ZMN; n = 804).
English: Nivolumab 3 mg/kg (events : 86/135), median and 95% CI : 9.23 (7.33, 13.27)
Slovenian: Nivolumab 3 mg/kg (dogodki: 86/135), mediana in 95 % IZ: 9,23 (7,33; 13,27) Docetaksel (dogodki: 113/137), mediana in 95 % IZ: 6,01 (5,13; 7,33)
English: Before you are given Nivolumab BMS, tell your doctor if you are taking any medicines that suppress your immune system, such as corticosteroids, since these medicines may interfere with the effect of Nivolumab BMS.
Slovenian: Preden boste prvič prejeli zdravilo Nivolumab BMS obvestite zdravnika, če jemljete katero koli zdravilo, ki zavira imunski sistem, kot so kortikosteroidi.
English: The total nivolumab dose in mg = the patient's weight in kg × the prescribed dose in mg/kg.
Slovenian: Celotni odmerek nivolumaba v mg = telesna masa bolnika v kg × predpisani odmerek v mg/kg.
English: BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.
Slovenian: Polska BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.
English: Although ECOG status, baseline glomerular filtration rate (GFR), albumin, body weight, and mild hepatic impairment had an effect on nivolumab CL, the effect was not clinically meaningful.
Slovenian: Stanje telesne zmogljivosti po lestvici ECOG, izhodiščna ocena glomerulne filtracije (GFR - glomerular filtration rate), vrednost albumina, telesna masa in blaga okvara jeter so sicer imeli vpliv na očistek nivolumaba, vendar pa
English: Nivolumab BMS should not be infused concomitantly in the same intravenous line with other medicinal products.
Slovenian: Zdravila Nivolumab BMS se ne sme infundirati sočasno z drugimi zdravili preko iste intravenske linije.
English: Baseline ECOG performance status score was 0 (24%) or
Slovenian: Ocena stanja telesne zmogljivosti po lestvici ECOG v izhodišču je bila 0 (24 %) ali 1 (76 %).
English: The use of systemic corticosteroids and other immunosuppressants at baseline, before starting nivolumab, should be avoided because of their potential interference with the pharmacodynamic activity.
Slovenian: Pred uvedbo zdravljenja z nivolumabom se je treba izogniti uporabi sistemskih kortikosteroidov in drugih zdravil za zaviranje imunske odzivnosti zaradi njihovega možnega vpliva na farmakodinamično aktivnost.
English: Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Slovenian: Zdravljenje mora trajati dokler je prisotna klinična korist oziroma dokler bolnik
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.
Slovenian: Do izboljšanja je prišlo pri 5 bolnikih (71 %), vključno z bolnikom s primerom stopnje 3, mediani čas do izboljšanja pa je znašal 5,9 tednov (razpon: 0,7-37,6+); + označuje krnjene podatke.
English: Grade 2 cases were reported in 3.6% (9/248) of patients.
Slovenian: O primerih stopnje 2 so poročali pri 3,6 % (9/248) bolnikov.
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
Slovenian: zmanjšanje števila rdečih krvnih celic (celice, ki prenašajo kisik), belih krvnih celic (celice, ki so pomembne za obrambo pred okužbami) ali trombocitov (celice, ki so potrebne za normalno nenormalni izvidi preiskav delovanja jeter (zvišanje vrednosti jetrnih encimov aspartat-aminotransferaze, alanin-aminotransferaze ali alkalne fosfataze v krvi, zvišanje nenormalni izvidi delovanja ledvic (zvišanje vrednosti kreatinina v krvi) nenormalne vrednosti kalcija, kalija, magnezija ali natrija v krvi zvišanje vrednosti encima, ki razgrajuje maščobe, in zvišanje vrednosti encima, ki razgrajuje
English: In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.
Slovenian: Na izogenskih mišjih modelih se po zavrtju aktivnosti PD-1 rast tumorja
English: Nivolumab is unlikely to affect your ability to drive or use machines; however, use caution when performing these activities until you are sure that nivolumab does not adversely affect you.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Verjetnost vpliva nivolumaba na sposobnost upravljanja vozil in strojev je majhna, vendar pa morate biti vseeno pozorni, da nivolumab pri vas nima negativnih vplivov na tovrstne aktivnosti.
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.
Slovenian: Študija CA209063 je bila odprta študija z enim krakom, izvedena pri 117 bolnikih z lokalno napredovalim ali metastatskim ploščatoceličnim NSCLC po dveh ali več predhodnih režimih zdravljenja.
English: Nivolumab BMS contains sodium
Slovenian: Zdravilo Nivolumab BMS vsebuje natrij
English: For Grade 2 transaminase or total bilirubin elevation, nivolumab should be withheld.
Slovenian: V primeru zvišanja vrednosti aminotransferaz ali skupnega bilirubina stopnje 2 je treba zdravljenje z nivolumabom zadržati.
English: Disease-related aetiologies should be ruled out.
Slovenian: Izključiti je treba vzroke, povezane z boleznijo.
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).
Slovenian: Na osnovi rezultatov populacijske farmakokinetike pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
English: By attaching to PD-1, nivolumab blocks its action and prevents it from switching off your T cells.
Slovenian: Nivolumab s pritrditvijo na PD-1 zavre njegovo delovanje in prepreči, da bi le-ta zavrl delovanje celic T. Na ta način pomaga povečati njihovo aktivnost proti pljučnim rakavim
English: Randomised phase 3 study vs. docetaxel (CA209017)
Slovenian: Randomizirana študija faze 3 v primerjavi z docetakselom (študija CA209017)
English: Do not use Nivolumab BMS after the expiry date which is stated on the carton and on the vial label after EXP.
Slovenian: Zdravila Nivolumab BMS ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega
English: Figure 1: Kaplan-Meier curves of OS (CA209017)
Slovenian: Slika 1: Kaplan-Meierjevi krivulji celokupnega preživetja (študija CA209017)
English: Based on the severity of the adverse reaction, nivolumab should be withheld and corticosteroids administered.
Slovenian: Na osnovi resnosti neželenega učinka je treba zdravljenje z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi.
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab treatment (see section 4.8).
Slovenian: Pri zdravljenju z nivolumabom so poročali o hudi pljučnici ali bolezni pljučnega intersticija, vključno s smrtnimi primeri (glejte poglavje 4.8).
English: Patients should be monitored for signs and symptoms of hepatitis such as transaminase and total bilirubin elevations.
Slovenian: Bolnike je treba nadzirati glede pojava znakov in simptomov hepatitisa, kot so zvišanje vrednosti aminotransferaz in skupnega bilirubina.
English: Eleven patients received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 1.1 mg/kg (range: 0.5-4.0) for a median total duration of 4.3 weeks (range: 0.6-13.1).
Slovenian: Enajst bolnikov je prejemalo visoke odmerke kortikosteroidov (odmerke, ki so ustrezali vsaj 40 mg prednizona) z medianim začetnim odmerkom 1,1 mg/kg (razpon: 0,5-4,0), zdravljenje pa je mediano v celoti trajalo 4,3 tedna (razpon: 0,6-13,1).
English: Single-arm phase 2 study (CA209063)
Slovenian: Študija faze 2 z enim krakom (študija CA209063)
English: or stop your treatment with Nivolumab BMS altogether.
Slovenian: ali zdravljenje z zdravilom Nivolumab BMS ukine.
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, diabetes mellitus, and diabetic ketoacidosis have been observed with nivolumab treatment.
Slovenian: Pri zdravljenju z nivolumabom so poročali o hudih endokrinopatijah, vključno s hipotiroidizmom, hipertiroidizmom, insuficienco nadledvičnih žlez, vnetjem hipofize, sladkorno boleznijo in diabetično
English: Monitoring of blood sugar should continue to ensure appropriate insulin replacement is utilised.
Slovenian: Za zagotovitev, da je zdravljenje z insulinom ustrezno, je treba kontinuirano nadzirati vrednosti krvnega sladkorja.
English: Withhold Nivolumab BMS until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete
Slovenian: zadržite dokler simptomi ne izzvenijo, se radiografsko ugotovljene nepravilnosti ne izboljšajo in zdravljenje s kortikosteroidi ni končano.
English: Resolution occurred in 6 patients (50%) with a median time to resolution of 20.6 weeks (0.4-47.6+); +
Slovenian: Do izboljšanja je prišlo pri 6 bolnikih (50 %), mediani čas do izboljšanja pa je znašal 20,6 tedna (0,4-47,6+); + označuje krnjene
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).
Slovenian: 4 ml koncentrata v 10-ml viali (steklo tipa I) z zamaškom (obložena butilna guma) in temnomodro dvižno zaporko (aluminij).
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).
Slovenian: Bolnike je treba seznaniti s tveganji, povezanimi z zdravljenjem z zdravilom Nivolumab BMS (glejte tudi navodilo za uporabo).
English: Use an infusion set and an in-line, sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Slovenian: Uporabite infuzijski sistem in sterilni, nepirogeni linijski filter, ki minimalno veže proteine (velikost por od 0,2 μm do 1,2 μm).
English: How to use Nivolumab BMS
Slovenian: Kako uporabljati zdravilo Nivolumab BMS
English: Do not use Nivolumab BMS if you are pregnant unless your doctor specifically tells you to.
Slovenian: Med nosečnostjo zdravila Nivolumab BMS ne smete uporabljati, razen na izrecno priporočilo zdravnika.
English: For Grade 2 diarrhoea or colitis, nivolumab should be withheld.
Slovenian: V primeru driske ali kolitisa stopnje 2 je treba zdravljenje z nivolumabom zadržati.
English: Resolution occurred in all 13 patients with a median time to resolution of 3.9 weeks (range: 0.6-13.4).
Slovenian: 13 bolnikih, mediani čas do izboljšanja pa je znašal 3,9 tedna (razpon: 0,6-13,4).
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).
Slovenian: Pri bolnikih z zmerno (skupni bilirubin > 1,5 × do 3 × ZMN in katera koli vrednost AST) ali s hudo okvaro jeter (skupni bilirubin > 3 × ZMN in katera koli vrednost AST)
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
Slovenian: Nivolumab je IgG4 in kot tak lahko preide iz matere na razvijajoči se plod.
English: Data from patients with moderate or severe hepatic impairment are too limited to draw conclusions on these populations.
Slovenian: Pri bolnikih z zmerno ali s hudo okvaro jeter je na voljo premalo podatkov, zato zaključkov za to populacijo ne moremo navesti.
English: However, systemic corticosteroids and other immunosuppressants can be used after starting nivolumab to treat immune-related adverse reactions.
Slovenian: Po uvedbi zdravljenja z nivolumabom pa se sistemske kortikosteroide in druga zdravila za zaviranje imunske odzivnosti lahko uporablja za zdravljenje imunsko pogojenih neželenih učinkov.
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.
Slovenian: Na osnovi podatkov analize populacijske farmakokinetike geometrijski srednji očistek nivolumaba znaša 9,5 ml/uro, končni razpolovni čas 26,7 dni, povprečna izpostavljenost v stanju dinamičnega ravnovesja pri uporabi odmerka 3 mg/kg na vsaka 2 tedna pa 75,3 µg/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.
Slovenian: in ≥ 30 ml/min/1,73 m2; n = 179) ali s hudo (GFR < 30 in ≥ 15 ml/min/1,73 m2; n = 2) okvaro ledvic v primerjavi z bolniki z normalnim delovanjem ledvic (GFR ≥ 90 ml/min/1,73 m2; n = 342).
English: Dosing delay or discontinuation may be required based on individual safety and tolerability.
Slovenian: Na osnovi varnosti ali prenašanja zdravila pri posameznem bolniku bo morda potrebno odmerek aplicirati z zamikom ali zdravljenje ukiniti.
English: Based on the population PK results, no dose adjustment is required in patients with mild hepatic impairment (see section 5.2).
Slovenian: Na osnovi rezultatov populacijske farmakokinetike pri bolnikih z blago okvaro jeter odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Median time to onset was 25.1 weeks (range: 4.1-31.1).
Slovenian: Mediani čas do pojava je znašal 25,1 tedna (razpon: 4,1-31,1).
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
Slovenian: Če ste v rodni dobi, morate med zdravljenjem z zdravilom Nivolumab BMS in še vsaj 5 mesecev po prejemu zadnjega odmerka zdravila Nivolumab BMS, uporabljati učinkovito obliko kontracepcije.
English: Administer the Nivolumab BMS infusion intravenously over a period of 60 minutes.
Slovenian: Nivolumab BMS raztopino za infundiranje morate aplicirati v obliki 60-minutne intravenske infuzije.
English: Median time to onset was 8.1 weeks (range: 0.3-51.9).
Slovenian: Mediani čas do pojava je znašal 8,1 tedna (razpon: 0,3-51,9).
English: If you miss a dose of Nivolumab BMS
Slovenian: Če niste prejeli odmerka zdravila Nivolumab BMS
English: Severe rash has been observed with nivolumab treatment that may be immune-related (see section 4.8).
Slovenian: Pri zdravljenju z nivolumabom so poročali o hudem izpuščaju, ki bi lahko bil imunsko pogojen (glejte poglavje 4.8).
English: Do not stop treatment with Nivolumab BMS unless you have discussed this with your doctor.
Slovenian: Zdravljenja z zdravilom Nivolumab BMS ne smete prekiniti, ne da bi se o tem najprej posvetovali z zdravnikom.
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%).
Slovenian: Zbrani podatki iz dveh študij, izvedenih pri ploščatoceličnem NSCLC (študija CA209017 in študija CA209063), kažejo, da so najpogostejši neželeni učinki (≥ 10 % bolnikov) bili utrujenost
English: Grade 3 anaphylactic reaction and Grade 4 hypersensitivity were each reported in 1 patient; both of these cases led to discontinuation and resolved with treatment.
Slovenian: O anafilaktični reakciji stopnje 3 in preobčutljivosti stopnje 4 so poročali pri po 1 bolniku.
English: Common increased total bilirubin,b decreased absolute neutrophil count,b hypermagnesaemia,b, hypernatraemiab
Slovenian: zvišanje vrednosti skupnega bilirubinab, zmanjšanje absolutnega števila nevtrofilcevb, hipermagneziemijab, hipernatriemijab občasni zvišanje vrednosti lipaze, zvišanje vrednosti amilaze a
English: Nivolumab BMS must not be administered as an intravenous push or bolus injection.
Slovenian: Zdravila Nivolumab BMS se ne sme aplicirati v obliki hitre intravenske ali bolusne injekcije.
English: Data from patients with severe renal impairment are too limited to draw conclusions on this population.
Slovenian: Pri bolnikih s hudo okvaro ledvic je na voljo premalo podatkov, zato zaključkov za to populacijo ne moremo navesti.
English: Median time to onset was 10.5 weeks (range: 2.1-27.0).
Slovenian: Mediani čas do pojava je znašal 10,5 tedna (razpon: 2,1-27,0).