natgillin/translations-raw huggingface dataset:
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. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z nivolumabom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2. 
Nivolumab je humano monoklonsko IgG4 (imunoglobulin G4) protitelo (HuMAb), ki se veže na receptor za programirano celično smrt-1 (PD-1) in zavira njegovo interakcijo s PD-L1 in PD-L2.
The rate of disease-related symptom improvement, as measured by LCSS, was similar between the nivolumab group (18.5%) and the docetaxel group (21.2%). 
Delež izboljšanja z boleznijo povezanih simptomov, ovrednoten po lestvici LCSS, je bil podoben med skupino z nivolumabom (18,5 %) in skupino z docetakselom (21,2 %).
These may be signs of inflammation of the lungs (pneumonitis or interstitial lung disease). 
To so lahko znaki vnetja pljuč (pljučnica ali bolezen pljučnega intersticija).
As with all therapeutic proteins, there is a potential for an immune response to nivolumab. 
Kot pri drugih terapevtskih beljakovinah tudi pri uporabi nivolumaba obstaja možnost imunskega odziva na nivolumab.
The educational programme is aimed at increasing the awareness about the potential immune mediated adverse events associated with Nivolumab BMS use, how to manage them and to enhance the awareness of patients or their caregivers on the signs and symptoms relevant to the early those adverse events. 
Izobraževalni program je namenjen povečanju ozaveščenosti o možnosti pojava imunsko pogojenih neželenih učinkov pri uporabi zdravila Nivolumab BMS, kako ukrepati v primeru njihovega pojava in okrepiti ozaveščenost bolnikov ali oseb, ki zanje skrbijo, o znakih in simptomih, ki so pomembni za zgodnje odkritje teh neželenih učinkov.
Other in-use storage time and conditions are the responsibility of the user. 
Za drugačen čas in pogoje shranjevanja med uporabo zdravila je odgovoren
The median age was 63 years (range: 39-85) with 44% ≥65 years of age and 11% ≥75 years of age. 
Mediana starost bolnikov je bila 63 let (razpon: 39-85), 44 % bolnikov je bilo starih ≥ 65 let, 11 % bolnikov pa ≥ 75 let.
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. 
V študiji 1. faze MDX1106-03 so o pnevmonitisu, vključno s stopnjo 4 pri 1 bolniku, poročali pri 3/37 bolnikov (8,1 %) z NSCLC, ki so prejemali nivolumab v odmerku 3 mg/kg.
Based on this prescribed dose, calculate the total dose to be given. 
Na osnovi predpisanega odmerka izračunajte celotni odmerek, ki ga boste aplicirali bolniku.
In addition, symptom improvement and overall health status were assessed using the Lung Cancer Symptom Score (LCSS) average symptom burden index and the EQ-5D Visual Analogue Scale (EQ-VAS), respectively. 
Poleg tega pa so vrednotili tudi izboljšanje simptomov in splošno zdravstveno stanje s pomočjo povprečnega indeksa bremena simptomov na lestvici LCSS (Lung Cancer Symptom Score) in vizualni analogni lestvici EQ-5D (EQ-VAS).
Do not store any unused portion of the infusion solution for reuse. 
Neporabljene raztopine za infundiranje ne shranjujte za ponovno uporabo.
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. 
Učinki zdravila Nivolumab BMS pri nosečnicah niso znani, vendar pa obstaja možnost, da zdravilna učinkovina nivolumab škoduje nerojenemu otroku.
See the end of section 4 for how to report side effects. 
Glejte na koncu poglavja 4, kako poročati o neželenih
Inflammation of the skin that can lead to rash and itching. 
vnetje kože, ki lahko povzroči izpuščaj in srbenje.
Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis. 
Zdravilo mora pripraviti ustrezno usposobljena oseba v skladu s pravili dobre prakse, še posebej glede aseptičnih pogojev.
No dose adjustment is required for elderly patients (≥ 65 years) (see sections 5.1 and 5.2). 
Pri starejših bolnikih (≥ 65 let) odmerka ni treba prilagajati (glejte poglavji 5.1 in 5.2).
Eight patients, including the 4 patients with a Grade 3 case, required permanent discontinuation of nivolumab due to pneumonitis. 
Pri osmih bolnikih, vključno s 4 bolniki s primerom stopnje 3, je bilo zaradi pnevmonitisa zdravljenje z nivolumabom treba trajno ukiniti.
Thirty-one percent had progressive disease reported as the best response to their most recent prior regimen and 45% received nivolumab within 3 months of completing their most recent prior regimen. 
Pri 31 % bolnikov je bolezen pri zadnjem predhodnem režimu zdravljenja napredovala, 45 % bolnikov pa je nivolumab prejelo v 3 mesecih po dokončanju zadnjega predhodnega režima zdravljenja.
Nivolumab BMS should not be frozen. 
Zdravila Nivolumab BMS ne smete zamrzovati.
Only 4 (0.8%) patients were persistent positive. 
Kot trajno pozitivne so označili le 4 bolnike (0,8 %).
There was a dose-dependent increase in foetal losses and increased neonatal mortality beginning in the third trimester. 
Poročali so o od odmerka odvisnem povečanju izgub plodov in o večji neonatalni umrljivosti od tretjega trimesečja dalje.
Your doctor will discuss these with you and will explain the risks and benefits of your treatment. 
Zdravnik se bo z vami pogovoril o možnih neželenih učinkih in vam pojasnil vsa tveganja in koristi
The recommended dose is 3 mg of nivolumab per kilogram of your body weight. 
Priporočeni odmerek je 3 mg nivolumaba na kilogram telesne mase.
You will receive treatment with Nivolumab BMS in a hospital or clinic, under the supervision of an experienced doctor. 
Zdravilo Nivolumab BMS boste prejeli v bolnišnici pod nadzorom zdravnika z ustreznimi izkušnjami.
Although hyperparathyroidism was not reported in CA209017, immune-related hyperparathyroidism might be considered especially if associated with hypophosphataemia (reported in 6 hypercalcemic patients in this study). 
V študiji CA209017 o hiperparatiroidizmu sicer niso poročali, vendar pa je treba razmisliti o imunsko pogojenem hiperparatiroidizmu, še posebej v povezavi s hipofosfatemijo (v tej študiji so o njej poročali pri 6 bolnikih s hiperkalciemijo).
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
Neutralising antibodies were detected in only 5 (1.0% of the total) of the positive anti-product-antibody patients. 
Nevtralizirajoča protitelesa so odkrili le pri 5 bolnikih (1,0 % vseh), ki so bili pozitivni na protitelesa proti zdravilu.
The prescribed dose for the patient is given in mg/kg. 
Predpisani odmerek za bolnika je podan v mg/kg.
The remaining offspring of nivolumab-treated females survived to scheduled termination, with no treatment-related clinical signs, alterations to normal development, organ-weight effects, or gross and microscopic pathology changes. 
Preostali mladiči samic, ki so prejemale nivolumab, so preživeli do predvidenega časa, brez kliničnih znakov, povezanih z uporabo zdravila, sprememb v normalnem razvoju, vplivov na maso organov ali makroskopskih in mikroskopskih patoloških sprememb.
Tumour assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks thereafter. 
Tumours, version 1.1) je bilo izvedeno 9 tednov po randomizaciji, nato pa se je nadaljevalo na vsakih 6 tednov.
Do not take any other medicines during your treatment without talking to your doctor first. 
Med zdravljenjem ne jemljite nobenega drugega zdravila, ne da bi se o tem najprej posvetovali z
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v
From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately. 
Z mikrobiološkega stališča je treba zdravilo infundirati ali razredčiti in infundirati takoj po odprtju
As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of nivolumab. 
Ker se monoklonska protitelesa ne presnavljajo z encimi citokroma P450 (CYP) ali drugimi presnovnimi encimi, ne pričakujemo, da bi zaviranje ali indukcija teh encimov zaradi sočasne uporabe drugih zdravil vplivala na farmakokinetiko nivolumaba.
Studies to evaluate the effect of nivolumab on fertility have not been performed. 
Študij, ki bi ovrednotile vpliv nivolumaba na plodnost, niso izvedli.
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"). 
Zdravila Nivolumab BMS ne smete prejeti če ste alergični na nivolumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6 “Vsebina pakiranja in dodatne informacije”).
If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up to 24 hours [a maximum of 4 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light]. 
Če se zdravila ne uporabi takoj, se raztopino lahko za največ 24 ur shrani v hladilniku (2 °C do 8 °C), zaščiteno pred svetlobo [od skupnih 24 ur je raztopina lahko največ 4 ure pri sobni temperaturi (20 °C do 25 °C) in sobni svetlobi].
Study CA209017 included a limited number of patients ≥ 75 years (11 in the nivolumab group and 18 in the docetaxel group). 
V študijo CA209017 je bilo vključeno omejeno število bolnikov, starih ≥ 75 let (11 bolnikov v skupini, ki je prejemala nivolumab, in 18 bolnikov v skupini, ki je prejemala docetaksel).
The updated data should be submitted by 31st December 
Dopolnjene podatke je treba predložiti do
Unless an alternate etiology has been identified, signs or symptoms of endocrinopathies should be considered immune-related. 
Če se ne ugotovi drugačne etiologije, je treba znake in simptome endokrinopatij obravnavati kot imunsko pogojene.
STEP 2 Transfer the concentrate into a sterile, evacuated glass bottle or intravenous container (PVC or 
Koncentrat prenesite v sterilno, izpraznjeno steklenico ali intravenski vsebnik (PVC ali
Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology. 
Nivolumab je pridobljen s tehnologijo rekombinantne DNA na ovarijskih celicah kitajskega hrčka.
Before treatment, your doctor will check your general health. 
Pred uvedbo zdravljenja bo zdravnik preveril vaše splošno zdravstveno stanje, med zdravljenjem pa opravljal krvne preiskave.
It contains the active substance nivolumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body. 
Nivolumab je monoklonsko protitelo, vrsta beljakovine, ki prepozna in se pritrdi na posebno ciljno
There were no reports of hypophysitis, diabetes mellitus, or diabetic ketoacidosis in these studies. 
O primerih vnetja hipofize, sladkorne bolezni ali diabetične kotoacidoze v teh študijah niso poročali.
Patients on controlled sodium diet 
Bolniki na dieti z nadzorovanim vnosom natrija
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. 
Pri bolnikih se lahko pojavijo utrujenost, glavobol, spremembe duševnega stanja, bolečina v trebuhu, neobičajno odvajanje blata in hipotenzija ali nespecifični simptomi, ki lahko spominjajo na druge vzroke, kot so zasevki v možganih ali osnovna bolezen.
No cases of overdose have been reported in clinical trials. 
V kliničnih preskušanjih niso poročali o primerih prevelikega odmerjanja.
Nivolumab BMS acts on your immune system and may cause inflammation in parts of your body. 
Zdravilo Nivolumab BMS deluje na imunski sistem in lahko povzroči vnetje posameznih delov telesa.
Based on its pharmacodynamic properties, nivolumab is unlikely to affect the ability to drive and use machines. 
Na osnovi farmakodinamičnih lastnosti nivolumaba je njegov vpliv na sposobnost vožnje in upravljanja s stroji malo verjeten.
Patients with active autoimmune disease, symptomatic interstitial lung disease, or untreated brain metastasis were excluded from the study. 
Bolnike z aktivno avtoimunsko boleznijo, simptomatsko boleznijo pljučnega intersticija ali nezdravljenimi zasevki v možganih so iz študije izključili.
It is very important for you to keep all your appointments to receive Nivolumab BMS. 
Zelo pomembno je, da prejmete vse predvidene odmerke zdravila Nivolumab BMS.
The preliminary results show that systemic immunosuppression after starting nivolumab treatment does not appear to preclude the response on nivolumab. 
Preliminarni rezultati kažejo, da sistemska imunosupresija po začetku zdravljenja z nivolumabom ne prepreči odziva na nivolumab.
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. 
Od 497 bolnikov, ki so se zdravili z nivolumabom v odmerku 3 mg/kg na vsaka 2 tedna, in so jih ovrednotili na prisotnost protiteles proti zdravilu, je bilo 51 bolnikov (10,3 %) pri testiranju s testom elektrokemiluminiscence (ECL) pozitivnih na protitelesa proti zdravilu.
It is available in packs containing either 1 vial of 4 mL or 1 vial of 10 mL. 
Zdravilo je na voljo v pakiranjih, ki vsebujejo 1 vialo s 4 ml zdravila ali 1 vialo z 10 ml zdravila.
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). 
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).
Problems with your lungs such as breathing difficulties or cough. 
Zdravilo lahko težave s pljuči, kot so težave z dihanjem ali kašelj.
It is not known whether nivolumab gets into breast milk. 
Ni znano, ali se nivolumab izloča v materino mleko.
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. 
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.
Recommendation for the use of hormone replacement therapy is provided in section 4.4. 
Priporočila za hormonsko nadomestno zdravljenje so navedena v poglavju 4.4.
Nivolumab CL increased with increasing body weight. 
Očistek nivolumaba se povečuje s povečevanjem telesne mase.
Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening and need treatment or withdrawal of nivolumab. 
Vnetje lahko resno škoduje telesu, nekatera vnetna stanja pa lahko tudi ogrozijo življenje, zato jih je treba ustrezno zdraviti ali zdravljenje z nivolumabom prekiniti.
The vials must be kept in the original package in order to protect from light. 
Viale shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately. 
V primeru prevelikega odmerjanja je treba bolnika skrbno nadzirati glede pojava znakov ali simptomov neželenih učinkov in nemudoma uvesti ustrezno simptomatsko zdravljenje.
The final infusion concentration should range between 1 and 10 mg/mL. 
Končna koncentracija raztopine za infundiranje mora biti v razponu od 1 do 10 mg/ml.
Nivolumab BMS must be stored in a refrigerator (2°C to 8°C). 
Zdravilo Nivolumab BMS shranjujte v hladilniku (2 °C do 8 °C).
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. 
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.
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). 
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).
What Nivolumab BMS is and what it is used for What you need to know before you use Nivolumab BMS 
Kaj je zdravilo Nivolumab BMS in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Nivolumab BMS Kako uporabljati zdravilo Nivolumab BMS
In study CA209017, hypercalcaemia was more frequently reported in the nivolumab group (31/130, 24%) than in the docetaxel group (9/124, 7%). 
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 %).
No Grade 3-5 thyroid disorders were reported. 
O boleznih ščitnice stopnje 3-5 niso poročali.
The patient will be provided with the Patient Alert Card with each prescription. 
Bolnik mora pri vsakem predpisu zdravila prejeti opozorilno kartico za bolnika.
Two patients (1 with Grade 2 rash and 1 with Grade 3 rash) required permanent discontinuation of nivolumab. 
Pri dveh bolnikih (1 bolnik z izpuščajem stopnje 2 in 1 bolnik z izpuščajem stopnje 3) je bilo treba zdravljenje z nivolumabom trajno ukiniti.
Nivolumab BMS is for intravenous use only. 
Zdravilo Nivolumab BMS je namenjeno le za intravensko uporabo.
Unopened vial 
NALEPKA VIALE
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). 
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).
Each vial contains either 40 mg (in 4 mL) or 100 mg (in 10 mL) of nivolumab. 
Ena viala vsebuje 40 mg (v 4 ml) ali 100 mg (v 10 ml) nivolumaba.
If you have any further questions about your treatment or on the use of this medicine, ask your doctor. 
Če imate o zdravljenju ali uporabi zdravila dodatna vprašanja, se posvetujte z zdravnikom.
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). 
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).
The incidence of adrenal insufficiency was 0.4% (1/248; Grade 3). 
Pojavnost insuficience nadledvičnih žlez je znašala 0,4 % (1/248; stopnje 3).
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). 
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).
4.2 Posology and method of administration Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. 
Zdravljenje mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju raka.
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. 
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)
Rapid tapering may lead to worsening of the adverse reaction. 
Pri hitrem zmanjševanju odmerka se neželeni učinek lahko poslabša.
The PFS was measured by RECIST version 1.1. 
Preživetje brez napredovanja bolezni so vrednotili na osnovi kriterijev RECIST, različica 1.1.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
Lonza Biologics, Inc. 
Lonza Biologics, Inc. 101 International Drive
All prescribers of Nivolumab BMS must be familiar with the Physician Information and Management Guidelines. 
Vsak zdravnik, ki predpisuje zdravilo Nivolumab BMS, se mora seznaniti z izobraževalnim gradivom za zdravnike in smernicami za ukrepanje.
The metabolic pathway of nivolumab has not been characterised. 
Presnovna pot nivolumaba ni bila opisana.
Data from patients with severe renal impairment are too limited to draw conclusions on this population (see section 4.2). 
Pri bolnikih s hudo okvaro ledvic je na voljo premalo podatkov, zato zaključkov za to populacijo ne moremo navesti (glejte poglavje 4.2).