FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Bolnike je treba nadzirati glede pojava kliničnih znakov in simptomov endokrinopatij in sprememb delovanja ščitnice (ob uvedbi zdravljenja, periodično med zdravljenjem in kot je indicirano na osnovi kliničnega pregleda).
English: Problems with your lungs such as breathing difficulties or cough.
Slovenian: Zdravilo lahko težave s pljuči, kot so težave z dihanjem ali kašelj.
English: It is not known whether nivolumab gets into breast milk.
Slovenian: Ni znano, ali se nivolumab izloča v materino mleko.
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.
Slovenian: Dodatno raziskati še vrednost drugih bioloških označevalcev poleg vrednosti statusa ekspresije PD-L1 na membrani tumorskih celic z IHC (npr. druge metode/testi in pripadajoče mejne vrednosti, ki bi lahko povečali občutljivost in specifičnost predvidevanja odziva na zdravljenje na osnovi PD-L1, PD-L2, tumorje infiltrirajočih limfocitov z določanjem gostote CD8+T, RNA podpisa ipd.) kot napovednika učinkovitosti nivolumaba.
English: Recommendation for the use of hormone replacement therapy is provided in section 4.4.
Slovenian: Priporočila za hormonsko nadomestno zdravljenje so navedena v poglavju 4.4.
English: Nivolumab CL increased with increasing body weight.
Slovenian: Očistek nivolumaba se povečuje s povečevanjem telesne mase.
English: Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening and need treatment or withdrawal of nivolumab.
Slovenian: Vnetje lahko resno škoduje telesu, nekatera vnetna stanja pa lahko tudi ogrozijo življenje, zato jih je treba ustrezno zdraviti ali zdravljenje z nivolumabom prekiniti.
English: The vials must be kept in the original package in order to protect from light.
Slovenian: Viale shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika skrbno nadzirati glede pojava znakov ali simptomov neželenih učinkov in nemudoma uvesti ustrezno simptomatsko zdravljenje.
English: The final infusion concentration should range between 1 and 10 mg/mL.
Slovenian: Končna koncentracija raztopine za infundiranje mora biti v razponu od 1 do 10 mg/ml.
English: Nivolumab BMS must be stored in a refrigerator (2°C to 8°C).
Slovenian: Zdravilo Nivolumab BMS shranjujte v hladilniku (2 °C do 8 °C).
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.
Slovenian: V študijah CA209017 in CA209063 je bil delež bolnikov s premikom od izhodiščnih vrednosti do laboratorijskih nepravilnosti stopnje 3 ali 4 naslednji: 13,2 % za zmanjšanje števila limfocitov, 9 % za hiponatriemijo, 2,9 % za hiperkalciemijo in hiperkaliemijo, 2,5 % za zmanjšanje vrednosti hemoglobina (vsa zmanjšanja stopnje 3), 2,0 % za hipokaliemijo, 1,6 % za zmanjšanje števila nevtrofilcev, 1,3 % za hipomagneziemijo, 1,2 % za hipokalciemijo, 0,8 % za zvišanje vrednosti skupnega bilirubina in 0,4 % za zvišanje vrednosti AST, zmanjšanje števila trombocitov, hipermagneziemijo in hipernatriemijo.
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).
Slovenian: Varnost in učinkovitost nivolumaba v odmerku 3 mg/kg kot samostojnega zdravila za zdravljenje napredovalega ali metastatskega ploščatoceličnega NSCLC so vrednotili v randomizirani, odprti študiji faze 3 (CA209017).
English: What Nivolumab BMS is and what it is used for What you need to know before you use Nivolumab BMS
Slovenian: Kaj je zdravilo Nivolumab BMS in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Nivolumab BMS Kako uporabljati zdravilo Nivolumab BMS
English: In study CA209017, hypercalcaemia was more frequently reported in the nivolumab group (31/130, 24%) than in the docetaxel group (9/124, 7%).
Slovenian: V študiji CA209017 so o hiperkalciemiji poročali pogosteje v skupini, ki je prejemala nivolumab (31/130, 24 %), kot v skupini, ki je prejemala docetaksel (9/124, 7 %).
English: No Grade 3-5 thyroid disorders were reported.
Slovenian: O boleznih ščitnice stopnje 3-5 niso poročali.
English: The patient will be provided with the Patient Alert Card with each prescription.
Slovenian: Bolnik mora pri vsakem predpisu zdravila prejeti opozorilno kartico za bolnika.
English: Two patients (1 with Grade 2 rash and 1 with Grade 3 rash) required permanent discontinuation of nivolumab.
Slovenian: Pri dveh bolnikih (1 bolnik z izpuščajem stopnje 2 in 1 bolnik z izpuščajem stopnje 3) je bilo treba zdravljenje z nivolumabom trajno ukiniti.
English: a
Slovenian: O
English: Nivolumab BMS is for intravenous use only.
Slovenian: Zdravilo Nivolumab BMS je namenjeno le za intravensko uporabo.
English: Unopened vial
Slovenian: NALEPKA VIALE
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).
Slovenian: Volumen koncentrata zdravila Nivolumab BMS za pripravo odmerka (ml) = celotni odmerek v mg deljeno z 10 (jakost koncentrata zdravila Nivolumab BMS je 10 mg/ml).
English: Each vial contains either 40 mg (in 4 mL) or 100 mg (in 10 mL) of nivolumab.
Slovenian: Ena viala vsebuje 40 mg (v 4 ml) ali 100 mg (v 10 ml) nivolumaba.
English: If you have any further questions about your treatment or on the use of this medicine, ask your doctor.
Slovenian: Če imate o zdravljenju ali uporabi zdravila dodatna vprašanja, se posvetujte z zdravnikom.
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).
Slovenian: Bolnike z izhodiščno oceno telesne zmogljivosti ≥ 2, aktivnimi zasevki v možganih ali avtoimunsko boleznijo, simptomatsko boleznijo pljučnega intersticija in bolnike, ki so se pred vključitvijo v študijo zdravili s sistemskimi imunosupresivi, so iz kliničnih preskušanj pri NSCLC izključili (glejte poglavji 4.5 in 5.1).
English: The incidence of adrenal insufficiency was 0.4% (1/248; Grade 3).
Slovenian: Pojavnost insuficience nadledvičnih žlez je znašala 0,4 % (1/248; stopnje 3).
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).
Slovenian: Če se ne uporabi takoj, je bilo dokazano, da je zdravilo Nivolumab BMS med uporabo kemijsko in fizikalno stabilno 24 ur, če se ga shranjuje pri temperaturi od 2 °C do 8 °C, zaščitenega pred svetlobo, in največ 4 ure pri temperaturi od 20 °C do 25 °C in sobni svetlobi (te 4 ure od skupnih 24 ur pa vključujejo tudi obdobje same aplikacije zdravila).
English: 4.2 Posology and method of administration Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Slovenian: Zdravljenje mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju raka.
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.
Slovenian: V študijo so bili vključeni bolniki (stari 18 let ali starejši) pri katerih je bolezen med ali po enem predhodnem režimu kemoterapije na osnovi dvojne platine napredovala in so imeli oceno stanja telesne zmogljivosti po lestvici ECOG (Eastern Cooperative Oncology Group)
English: docetaxel (n = 137)
Slovenian: (n = 137)
English: Rapid tapering may lead to worsening of the adverse reaction.
Slovenian: Pri hitrem zmanjševanju odmerka se neželeni učinek lahko poslabša.
English: The PFS was measured by RECIST version 1.1.
Slovenian: Preživetje brez napredovanja bolezni so vrednotili na osnovi kriterijev RECIST, različica 1.1.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
English: Lonza Biologics, Inc.
Slovenian: Lonza Biologics, Inc. 101 International Drive
English: All prescribers of Nivolumab BMS must be familiar with the Physician Information and Management Guidelines.
Slovenian: Vsak zdravnik, ki predpisuje zdravilo Nivolumab BMS, se mora seznaniti z izobraževalnim gradivom za zdravnike in smernicami za ukrepanje.
English: The metabolic pathway of nivolumab has not been characterised.
Slovenian: Presnovna pot nivolumaba ni bila opisana.
English: Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 4.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic je na voljo premalo podatkov, zato zaključkov za to populacijo ne moremo navesti (glejte poglavje 4.2).
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.
Slovenian: Zdravljenje z zdravilom Nivolumab BMS je treba trajno ukiniti tudi v primeru pojava imunsko pogojenih neželenih učinkov stopnje 2 ali 3, ki kljub prilagoditvi zdravljenja ne minejo (glejte poglavje 4.4), ali v primeru, če odmerka kortikosteroida ni mogoče zmanjšati na 10 mg prednizona ali enakovrednega odmerka na dan.
English: A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, tumour type, tumour size, and hepatic impairment.
Slovenian: Analiza podatkov populacijske farmakokinetike ne kaže razlik v očistku nivolumaba glede na starost, spol, raso, vrsto tumorja, velikost tumorja in okvaro jeter.
English: Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes).
Slovenian: sladkorno bolezen (simptomi vključujejo prekomerno žejo, izločanje večje količine urina, povečan apetit z zmanjšanjem telesne mase, občutek utrujenosti, zaspanosti, oslabelosti, depresije, razdražljivosti in splošnega slabega počutja) ali diabetično ketoacidozo (kopičenje kisline v krvi zaradi sladkorne bolezni).
English: These reactions are presented by system organ class and by frequency.
Slovenian: Neželeni učinki so navedeni po organskih sistemih in pogostnosti.
English: 30th September 2017
Slovenian: 30. september 2017
English: In the absence of data, nivolumab should be used with caution in these populations after careful consideration of the potential risk-benefit on an individual basis.
Slovenian: Zaradi pomanjkanja podatkov je treba nivolumab pri teh populacijah bolnikov uporabljati previdno in pred uvedbo zdravljenja skrbno ovrednotiti razmerje med možnim tveganjem in koristjo pri vsakem bolniku posebej.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika
English: However, based on its mechanism of action, foetal exposure to nivolumab may increase the risk of developing immune-related disorders or altering the normal immune response and immune-related disorders have been reported in PD-1 knockout mice.
Slovenian: Vendar pa se na osnovi mehanizma delovanja nivolumaba pri izpostavljenosti ploda nivolumabu lahko poveča tveganje za razvoj imunsko pogojenih bolezni ali spremeni normalni imunski odziv.
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.
Slovenian: Znaki in simptomi hepatitisa lahko vključujejo nenormalne izvide preiskav delovanja jeter, rumeno obarvanje oči ali kože (zlatenica), bolečino v desnem predelu trebuha ali utrujenost.
English: Median time to onset of these endocrinopathies was 17.8 weeks (range: 6.1-33.1).
Slovenian: Mediani čas do pojava teh endokrinopatij je znašal 17,8 tedna (razpon: 6,1-33,1).
English: Diarrhoea (watery, loose or soft stools) or any symptoms of inflammation of the intestines (colitis), such as stomach pain and mucus or blood in stool.
Slovenian: drisko (vodeno, kašasto ali mehko blato) ali kateri koli simptom vnetja črevesa (kolitis), kot so bolečina v trebuhu in sluz ali kri v blatu.
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.
Slovenian: O naslednjih imunsko pogojenih neželenih učinkih so poročali pri manj kot 1 % bolnikov, ki so se v kliničnih preskušanjih zdravili z nivolumabom v različnih odmerkih in zaradi različnih vrst tumorjev: pankreatitis, uveitis, demielinizacija, avtoimunska nevropatija (vključno s parezo obraznega in abducentnega živca), Guillain-Barréjev sindrom, hipopituitarizem in miastenijski sindrom.
English: These analyses will be conducted in Studies CA 209037 and CA209066 in patients with advanced melanoma.
Slovenian: Te analize bodo izvedene v študijah CA209037 in CA209066 pri bolnikih z
English: In case of a severe infusion reaction, nivolumab infusion must be discontinued and appropriate medical therapy administered.
Slovenian: V primeru pojava hude infuzijske reakcije je treba infundiranje nivolumaba prekiniti in uvesti ustrezno zdravljenje.
English: Nivolumab BMS infusion must be completed within 24 hours of preparation.
Slovenian: Raztopina zdravila Nivolumab BMS, pripravljena za infundiranje Infundiranje zdravila Nivolumab BMS je treba dokončati v 24 urah po pripravi.
English: The recommended dose of Nivolumab BMS is 3 mg/kg administered intravenously over 60 minutes every 2 weeks.
Slovenian: Priporočeni odmerek zdravila Nivolumab BMS je 3 mg/kg v obliki 60-minutne intravenske infuzije na vsaka 2 tedna.
English: Signs and symptoms may include abnormal kidney function tests, or decreased volume of urine.
Slovenian: Znaki in simptomi lahko vključujejo nenormalne izvide preiskav delovanja ledvic ali zmanjšanje volumna izločenega seča.
English: Signs and symptoms that these glands are not working properly may include fatigue (extreme tiredness), weight change or headache and visual disturbances.
Slovenian: Znaki in simptomi okvare delovanja teh žlez lahko vključujejo izčrpanost (ekstremno utrujenost), spremembe telesne mase ali glavobol in motnje vida.
English: Patients should be monitored for signs and symptoms of nephritis and renal dysfunction.
Slovenian: Bolnike je treba nadzirati glede pojava znakov in simptomov nefritisa in okvare delovanja ledvic.
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.
Slovenian: Skupno 272 bolnikov so randomizirali na zdravljenje z nivolumabom v odmerku 3 mg/kg (N = 135) v obliki 60-minutne intravenske infuzije na vsaka 2 tedna ali na zdravljenje z docetakselom (n = 137) v odmerku 75 mg/m2 na vsake 3 tedne.
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.
Slovenian: in PD-L2, ki ju izražajo antigen predstavitvene celice in sta lahko izražena na tumorskih in drugih celicah v mikrookolju tumorja, je zavrtje proliferacije celic T in sekrecije citokinov.
English: It is to be administered as an intravenous infusion over a period of 60 minutes.
Slovenian: Aplicirati ga je treba v obliki 60-minutne intravenske infuzije.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
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).
Slovenian: Podatki v nadaljevanju navedenih imunsko pogojenih neželenih učinkov so bili pridobljeni pri bolnikih, ki so prejemali nivolumab v odmerku 3 mg/kg v dveh študijah NSCLC (študija CA209017 in študija CA209063, glejte poglavje 5.1).
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).
Slovenian: 10 ml koncentrata v 10-ml viali (steklo tipa I) z zamaškom (obložena butilna guma) in sivo dvižno zaporko (aluminij).
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.
Slovenian: Če se za zdravljenje neželenega učinka uporabi imunosupresivno zdravljenje s kortikosteroidi, je treba po izboljšanju uvesti vsaj 1-mesečno postopno zmanjševanje odmerka.
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.
Slovenian: Med zdravljenjem z zdravilom Nivolumab BMS pa vam zdravnik lahko predpiše zdravljenje s kortikosteroidi za ublažitev katerega koli možnega neželenega učinka, ki se lahko pojavi med zdravljenjem.
English: What Nivolumab BMS looks like and contents of the pack Nivolumab BMS concentrate for solution for infusion (sterile concentrate) is a clear to opalescent, colourless to pale yellow liquid that may contain few light particles.
Slovenian: Izgled zdravila Nivolumab BMS in vsebina pakiranja Nivolumab BMS koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra do opalescentna, brezbarvna do svetlorumena tekočina, ki lahko vsebuje manjše število neznatnih delcev.
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.
Slovenian: Bolnike je treba nadzirati glede pojava znakov in simptomov pljučnice, kot so radiografske spremembe (npr. fokalni vzorci mlečnega stekla, krpasti infiltrati), dispneja in hipoksija.
English: The management guidelines for these adverse reactions are described in section 4.4.
Slovenian: Smernice za zdravljenje teh neželenih učinkov so navedene v poglavju 4.4.
English: Treatment was continued as long as clinical benefit was observed or until treatment was no longer tolerated.
Slovenian: Zdravljenje je trajalo dokler je bila prisotna klinična korist ali dokler je bolnik zdravljenje prenašal.
English: Nivolumab is most commonly associated with immune-related adverse reactions.
Slovenian: Uporaba nivolumaba je bila najpogosteje povezana s pojavom imunsko pogojenih neželenih učinkov.
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.
Slovenian: Mišično-skeletna bolečina je sestavljen izraz, ki obsega bolečino v hrbtu, bolečino v kosteh, mišično-skeletno bolečino v predelu prsnega koša, mišično-skeletno nelagodje, bolečino v mišicah, bolečino v vratu, bolečino v okončinah, bolečino v čeljusti in bolečino v hrbtenici.
English: Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Slovenian: Podrobne smernice za zdravljenje imunsko pogojenih neželenih učinkov so navedene v poglavju 4.4.
English: The prescriber must discuss the risks of Nivolumab BMS therapy with the patient.
Slovenian: Zdravnik mora bolniku pojasniti tveganja, povezana z zdravljenjem z zdravilom Nivolumab BMS.
English: Withdraw the required volume of Nivolumab BMS concentrate using an appropriate sterile
Slovenian: Potrebni volumen koncentrata zdravila Nivolumab BMS izvlecite v ustrezno sterilno injekcijsko
English: Most patients
Slovenian: Pri bolnikih,
English: Adverse reactions reported in the pooled dataset (n=248) of CA209017 and CA209063 are presented in Table 2.
Slovenian: Neželeni učinki na osnovi zbranih podatkov (n=248) študije CA209017 in študije CA209063 so prikazani v preglednici 2.
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.
Slovenian: Na mišjih modelih gestacije je bilo dokazano, da zavrtje PD-L1 signalne poti poruši toleranco za plod in poveča izgube plodov.
English: Other medicines and Nivolumab BMS
Slovenian: Druga zdravila in zdravilo Nivolumab BMS
English: Nivolumab BMS is a medicine used to treat advanced non-small cell lung cancer (a type of lung cancer) in adults.
Slovenian: Kaj je zdravilo Nivolumab BMS in za kaj ga uporabljamo Zdravilo Nivolumab BMS uporabljamo za zdravljenje napredovalega nedrobnoceličnega pljučnega raka (vrsta pljučnega raka) pri odraslih.
English: These additional biomarker analyses are occurring in the context of Study CA209-038 and Study CA209-066.
Slovenian: Te dodatne analize bioloških označevalcev se izvedejo v okviru študije CA209-038 in študije
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.
Slovenian: Bolniki z zdravljenimi zasevki v možganih so bili primerni za vključitev, če se je nevrološko stanje povrnilo do izhodiščnega stanja vsaj 2 tedna pred vključitvijo in se niso zdravili s kortikosteroidi ali pa so se zdravili s stabilnim ali manjšajočim se odmerkom kortikosteroida, ki je
English: Tell your doctor immediately if you have any of these signs or symptoms or if they get worse.
Slovenian: Če opazite katerega koli od teh znakov ali simptomov ali če znaki ali simptomi postajajo hujši, o tem nemudoma obvestite zdravnika.
English: Recommended treatment modifications for Nivolumab BMS
Slovenian: Priporočene prilagoditve zdravljenja z zdravilom Nivolumab BMS
English: Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PDL1 positive (tumour membrane expression cut off of 1%, 5% or 10%).
Slovenian: Korist za preživetje je bila opažena ne glede na PD-L1 negativno ali PD-L1 pozitivno označenost tumorja