natgillin/translations-raw huggingface dataset:
Management recommendations for diarrhoea or colitis are based on severity of symptoms (per NCI-CTCAE v4 severity grading classification). 
Priporočila za ukrepanje v primeru driske ali kolitisa temeljijo na resnosti simptomov (po klasifikaciji stopenj resnosti NCI-CTCAE v4).
In the two observational studies, 12.1% and 33.1% of the patients had brain metastases at the time of advanced melanoma diagnosis. 
V dveh opazovalnih študijah je imelo 12,1 % oz. 33,1 % pacientov ob postavitvi diagnoze napredovalega melanoma metastaze v možganih.
YERVOY is not recommended during pregnancy or in women of childbearing potential not using effective contraception, unless the clinical benefit outweighs the potential risk. 
Zdravila YERVOY ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, razen v primeru, ko klinična korist odtehta možno tveganje.
Renal Cell Carcinoma (RCC) 
Karcinom ledvičnih celic (RCC)
Assessment of tumour response to ipilimumab was conducted at approximately Week 12, after completion of induction therapy. 
Vrednotenje odziva tumorja na zdravljenje z ipilimumabom je bilo opravljeno približno v 12. tednu, po dokončanem indukcijskem zdravljenju.
Skin: Moderate to severe (Grade 3)b skin rash or (Grade 2) 
Koža: zmeren do hud (stopnja 3)b kožni izpuščaj ali (stopnja 2)
The use of anticoagulants is known to increase the risk of gastrointestinal haemorrhage. 
Znano je, da se pri uporabi antikoagulantov poveča tveganje za pojav gastrointestinalne krvavitve.
YERVOY has minor influence on the ability to drive and use machines. 
Zdravilo YERVOY ima blag vpliv na sposobnost vožnje in upravljanja strojev.
The adverse reaction mostly responded well to treatment with corticosteroids. 
Neželeni učinek se je večinoma dobro odzval na zdravljenje s kortikosteroidi.
• Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen. 
• Opis glavnih simptomov imunsko pogojenih neželenih učinkov in pomembnost takojšnjega obveščanja zdravnika, če se ti neželeni učinki pojavijo, vztrajajo ali poslabšajo.
Overall survival (OS) was also evaluated. 
Vrednotili so tudi celokupno preživetje.
A total of 77 patients had a history of previously treated brain metastases. 
Skupaj 77 bolnikov je imelo v anamnezi predhodno zdravljene zasevke v možganih.
See section 4.4 for detailed management guidelines. 
Za podrobne smernice za ukrepanje glejte poglavje 4.4.
• Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and need to be addressed immediately 
• Informacija, da lahko ipilimumab povzroči resne neželene učinke na številnih delih telesa, ki lahko povzročijo smrt in jih je treba nemudoma začeti zdraviti.
Most patients were male (58%) and white (92%). 
Večina bolnikov je bilo moškega spola (58 %) in belcev (92 %).
These medicines may interfere with the effect of YERVOY. 
Ta zdravila lahko vplivajo na učinek zdravila YERVOY.
MedDRA v.17.0 for CA184070, v.19.0 for CA184178, and V.12.1 for Adult Safety Pool. 
MedDRA različica 17.0 za študijo CA184070, različica 19.0 za študijo CA184178 in različica 12.1 za združene podatke o varnosti pri odraslih.
The relationship of these malformations to treatment is unclear. 
Povezava med temi razvojnimi nepravilnostmi in uporabo zdravila ni jasna.
• Brief introduction to ipilimumab (and the purpose of this risk minimisation tool). 
• Kratka predstavitev ipilimumaba (in namen tega vodnika).
It is available in packs containing either 1 glass vial of 10 ml or 1 glass vial of 40 ml. 
Zdravilo je na voljo v pakiranjih, ki vsebujejo 1 stekleno vialo z 10 ml zdravila ali 1 stekleno vialo s 40 ml zdravila.
(HR 0.89 with a 95% CI of 0.76, 1.04 and log-rank test P-value = 0.1548). 
(HR 0,89 s 95 % intervalom zaupanja: 0,76; 1,04 in log-rank test P-vrednost = 0,1548).
Transfer the concentrate into a sterile, evacuated glass bottle or intravenous bag (PVC or non-PVC). 
Koncentrat prenesite v sterilno, izpraznjeno intravensko infuzijsko steklenico ali vrečko (PVC ali ne-PVC tipa).
Before you are given YERVOY, tell your doctor if you are taking any medicines that suppress your immune system, such as corticosteroids. 
Preden prvič prejmete zdravilo YERVOY, obvestite zdravnika, če jemljete katero koli zdravilo, ki deluje zaviralno na imunski sistem, kot so na primer kortikosteroidi.
The effects of YERVOY in pregnant women are not known, but it is possible that the active substance, ipilimumab, could harm an unborn baby. 
Učinki zdravila YERVOY pri nosečnici niso znani, vendar pa obstaja možnost, da učinkovina ipilimumab škoduje nerojenemu otroku.
Assessments of tumour response should be conducted only after completion of induction therapy. 
Vrednotenje odziva tumorja je treba izvesti šele po zaključenem indukcijskem zdravljenju.
if you have previously experienced a severe skin adverse reaction on a prior cancer therapy. 
če se je pri vas pri predhodnem zdravljenju raka že kdaj pojavila huda kožna reakcija.
It is currently unknown if the corticosteroid treatment reverses the gland dysfunction. 
Trenutno ni znano, če zdravljenje s kortikosteroidi obnovi delovanje žleze.
Other side effects that have been reported (frequency not known) with ipilimumab in combination with nivolumab include: 
Drugi neželeni učinki, o katerih so poročali (njihova pogostnost ni znana) pri uporabi ipilimumaba v kombinaciji z nivolumabom, so:
Upon repeated dosing of ipilimumab administered every 3 weeks, CL was found to be time-invariant, and minimal systemic accumulation was observed as evident by an accumulation index 1.5 fold or less. 
Pri ponavljajočem se odmerjanju ipilimumaba na vsake 3 tedne so ugotovili, da se očistek ne spreminja s časom, opaženo pa je bilo tudi minimalno sistemsko kopičenje, kar je razvidno iz indeksa akumulacije 1,5-krat ali manj.
Vogt-Koyanagi-Harada syndromeh 
Sindrom Vogt-Koyanagi-Haradah
Very rare (may affect up to 1 in 10,000 people) Serious, potential life-threatening allergic reaction 
Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov) resne alergijske reakcije, ki so lahko smrtno nevarne
Be aware of important symptoms of inflammation YERVOY acts on your immune system and may cause inflammation in parts of your body. 
Bodite pozorni na pomembne simptome vnetja Zdravilo YERVOY deluje na imunski sistem in lahko povzroči vnetje na posameznih delih telesa.
What YERVOY is and what it is used for 
Kaj je zdravilo YERVOY in za kaj ga uporabljamo
Calculating the dose: 
Določitev odmerka:
What you need to know before you use YERVOY 
Kaj morate vedeti, preden boste uporabili zdravilo YERVOY
NA = not assessed For adults, deaths reported in this table are within 70 days of the last dose, regardless of relationship. 
Pri odraslih je do smrtnih izidov, navedenih v tej preglednici, prišlo v 70 dneh po zadnjem odmerku, ne glede na povezavo.
For storage conditions after first opening or dilution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po prvem odprtju ali redčenju zdravila glejte poglavje 6.3.
These medicines may increase the likelihood of bleeding in the stomach or intestine, which is a sideeffect of YERVOY. 
Ta zdravila lahko povečajo verjetnost za pojav krvavitev v želodcu ali črevesu, kar je neželeni učinek zdravila YERVOY.
Other medicines and YERVOY 
Druga zdravila in zdravilo YERVOY
Cmax, Cmin and AUC of ipilimumab were found to be dose proportional within the dose range examined. 
Vrednosti Cmax, Cmin in AUC ipilimumaba so bile v preiskovanem razponu odmerkov proporcionalne z odmerkom.
10 months 
10 mesecev
Based on a population PK analysis using available pooled data from 565 patients from 4 phase 2 adult studies (N=521) and 2 paediatric studies (N=44), CL of ipilimumab increased with increasing baseline body weight. 
Na osnovi analize populacijske farmakokinetike z uporabo razpoložljivih združenih podatkov pri 565 bolnikih iz 4 študij 2. faze pri odraslih (N=521) in 2 pediatričnih študij (N=44) se očistek ipilimumaba povečuje s povečevanjem izhodiščne telesne mase.
Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with ipilimumab in combination with nivolumab may occur at any time during or after discontinuation of therapy. 
Bolnike je treba neprestano nadzirati (še vsaj do 5 mesecev po aplikaciji zadnjega odmerka), saj se neželeni učinki ipilimumaba v kombinaciji z nivolumabom lahko pojavijo kadarkoli med zdravljenjem ali po ukinitvi zdravljenja.
Ipilimumab is associated with inflammatory adverse reactions resulting from increased or excessive immune activity (immune-related adverse reactions), likely to be related to its mechanism of action. 
Ipilimumab je povezan z vnetnimi neželenimi učinki, ki so posledica povečane ali prekomerne imunske aktivnosti (imunsko pogojeni neželeni učinki), kar je verjetno povezano z mehanizmom njegovega delovanja.
Summary of Adverse Events after up to Four Doses of 3, 5 and 10 mg/kg, All Treated Patients 
Povzetek neželenih učinkov po uporabi do štirih odmerkov 3, 5 in 10 mg/kg, vsi zdravljeni bolniki
At the recommended dose of 3 mg/kg median OS was similar in the subgroup of females ≥ 50 years of age compared to the overall population: (11.40 vs 11.53 months). 
Pri uporabi priporočenega odmerka 3 mg/kg je bila mediana celokupnega preživetja v podskupini žensk, starih 50 let ali starejših, podobna kot v celotni populaciji: (11,40 v primerjavi z 11,53 meseca).
Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening. 
Vnetje lahko resno škoduje telesu, nekatera vnetna stanja pa lahko tudi ogrozijo življenje.
No dose reduction of YERVOY is recommended. 
Zmanjšanje odmerka zdravila YERVOY ni priporočljivo.
Only very limited data are available in children younger than 12 years of age. 
Pri otrocih, mlajših od 12 let, je na voljo zelo malo podatkov.
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). 
Uporabite infuzijski sistem in sterilni, nepirogeni filter, ki minimalno veže proteine (velikost por od 0,2 μm do 1,2 μm).
The majority (71-73%) of patients had M1c stage disease and 37-40% of patients had an elevated lactate dehydrogenase (LDH) at baseline. 
Večina bolnikov (71-73 %) je imela M1c stadij bolezni in 37-40 % bolnikov je imelo zvišane vrednosti laktat-dehidrogenaze (LDH) v izhodišču.
• Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of immune-related adverse reactions in section 4.4 of the SmPC. 
• Opozorilo, da lahko ipilimumab povzroči resne neželene učinke na številnih delih telesa, ki lahko povzročijo smrt in zahtevajo hitro ukrepanje, kot je opisano v smernicah za ukrepanje v primeru imunsko pogojenih neželenih učinkov v poglavju 4.4 Povzetka glavnih značilnosti zdravila.
• Patient Information Brochures including Alert Cards 
• Vodnik z informacijami za bolnike, vključno z opozorilnimi karticami.
Overall, no apparent association was observed between antibody development and adverse reactions. 
Gledano v celoti, niso ugotovili očitne povezave med razvojem protiteles in pojavom neželenih učinkov.
Ipilimumab is a T-cell potentiator that enables the immune response (see section 5.1) and may interfere with immunosuppressive therapy, resulting in an exacerbation of the underlying disease or increased risk of graft rejection. 
Ipilimumab je potenciator limfocitov T, ki omogočajo imunski odziv (glejte poglavje 5.1), in lahko vpliva na imunosupresivno zdravljenje, kar lahko povzroči poslabšanje osnovne bolezni ali poveča tveganje za zavrnitev presadka.
Table 11: Objective response (CA209067) 
Preglednica 11: Objektivni odziv (študija CA209067)
Grade 4 creatinine elevation 
Zvišanje vrednosti kreatinina stopnje 4
How YERVOY is given YERVOY will be given to you in a hospital or clinic under the supervision of an experienced doctor. 
Način uporabe zdravila YERVOY Zdravilo YERVOY boste prejeli v bolnišnici pod nadzorom zdravnika z ustreznimi izkušnjami.
Objective response (95% CI) Odds ratio (vs. ipilimumab) (99.5% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Duration of response Median (range), months 
Objektivni odziv (95% IZ) Razmerje obetov (v primerjavi z ipilimumabom) (99,5% IZ) Popolni odziv (CR) Delni odziv (PR) Stabilna bolezen (SD) Trajanje odziva Mediana (razpon), meseci ni dosežena
Data from first-line RCC patients 75 years of age or older are too limited to draw conclusions on this population (see section 5.1). 
Pri bolnikih z RCC, zdravljenih v prvi liniji, starih 75 let ali starejših, je na voljo premalo podatkov, zato zaključkov za to populacijo ni mogoče navesti (glejte poglavje 5.1).
Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that ipilimumab does not adversely affect them. 
Ker obstaja možnost za pojav neželenih učinkov, kot je utrujenost (glejte poglavje 4.8), je treba bolnikom svetovati previdnost pri vožnji in upravljanju s stroji, dokler se z gotovostjo ne izkaže, da ipilimumab pri njih nima škodljivih vplivov na tovrstne aktivnosti.
Based on early data, the combination of YERVOY (ipilimumab) and vemurafenib is not recommended due to increased toxicity to the liver. 
Na osnovi prvih podatkov kombinacija zdravila YERVOY (ipilimumab) in vemurafeniba ni priporočljiva zaradi povečanega toksičnega vpliva na jetra.
Treatment beyond initial investigator-assessed RECIST, version 1.1-defined progression was permitted if the patient had a clinical benefit and was tolerating study drug as determined by the investigator. 
Zdravljenje po začetnem napredovanju bolezni po merilih RECIST, različica 1.1 je bilo dovoljeno, če je po presoji raziskovalca pri bolniku bila prisotna klinična korist in je bolnik študijsko zdravilo prenašal.
Treatment should be continued in the presence of hormone replacement therapya as long as no symptoms are present 
Zdravljenje se ob hormonskem nadomestnem zdravljenju lahko nadaljujea, dokler ni prisotnih simptomov.
Two (25.0%) of 8 patients treated with 5 mg/kg and 1 (11.1%) of 9 patients treated with 10 mg/kg reported Grade 3-4 events. 
Pri dveh (25,0 %) od 8 bolnikov, ki so se zdravili z odmerkom 5 mg/kg, in 1 (11,1 %) od 9 bolnikov, ki so se zdravili z odmerkom 10 mg/kg, so poročali o neželenih učinkih stopnje 3-4.
Symptoms may also include visual field defects, behavioural changes, electrolyte disturbances, and hypotension. 
Simptomi lahko vključujejo tudi motnje v vidnem polju, vedenjske spremembe, motnje elektrolitov in hipotenzijo.
Additionally, based on these relationships, there were no clinically significant differences between a nivolumab dose of 480 mg every 4 weeks or 3 mg/kg every 2 weeks in advanced melanoma and RCC. 
Poleg tega pa na osnovi teh razmerij tudi ni klinično pomembnih razlik med uporabo nivolumaba v odmerku 480 mg vsake 4 tedne ali 3 mg/kg vsaka 2 tedna pri napredovalem melanomu in RCC.
Withdraw the required volume of YERVOY concentrate using an appropriate sterile syringe. 
Potrebni volumen koncentrata zdravila YERVOY izvlecite v ustrezno sterilno injekcijsko brizgo.
Animal reproduction studies have shown reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Ipilimumab is a human monoclonal antibody that is not metabolized by cytochrome P450 enzymes (CYPs) or other drug metabolizing enzymes. 
Ipilimumab je humano monoklonsko protitelo, ki se ne presnavlja z encimi citokroma P450 (CYP) ali drugimi presnovnimi encimi.
A Phase 3, double-blind study enrolled patients with advanced (unresectable or metastatic) melanoma who had previously been treated with regimens containing one or more of the following: IL-2, dacarbazine, temozolomide, fotemustine, or carboplatin. 
Dvojno slepa študija 3. faze je vključevala bolnike z napredovalim (neoperabilnim ali metastatskim) melanomom, ki so se predhodno že zdravili z režimi, ki so vključevala enega ali več naslednjih zdravil: IL-2, dakarbazin, temozolomid, fotemustin ali karboplatin.
Median age was 15 years. 
Mediana starosti je bila 15 let.
If you stop using YERVOY 
Če ste prenehali uporabljati zdravilo YERVOY
A rare disease in which our immune system makes too many of otherwise normal infection fighting cells called histiocytes and lymphocytes. 
Redka bolezen, pri kateri imunski sistem tvori preveč sicer normalnih celic, ki se borijo proti okužbam, imenovanih histiociti in limfociti.
Studies to evaluate the mutagenic and carcinogenic potential of ipilimumab have not been performed. 
Študije, ki bi ovrednotile mutageni ali kancerogeni potencial ipilimumaba, niso bile izvedene.
YERVOY may cause changes in the results of tests carried out by your doctor. 
Zdravilo YERVOY lahko povzroči spremembe v rezultatih preiskav, ki jih bo opravil zdravnik.
Since gastrointestinal haemorrhage is an adverse reaction with ipilimumab (see section 4.8), patients who require concomitant anticoagulant therapy should be monitored closely. 
Ker je gastrointestinalna krvavitev tudi neželeni učinek ipilimumaba (glejte poglavje 4.8), je treba bolnike, ki potrebujejo sočasno zdravljenje z antikoagulanti, skrbno nadzirati.
The effect of race was not examined as there was insufficient data in non-Caucasian ethnic groups. 
Vpliv rase ni bil ovrednoten, saj je bilo pri ostalih rasah, razen pri belcih, na voljo premalo podatkov.
Patients with ocular melanoma were not included in the CA184-169 clinical trial. 
Bolniki z očesnim melanomom niso bili vključeni v klinično preskušanje CA184-169.
NCI-CTCAE v4 Gradea 
Stopnja po NCI-CTCAE v4a
Please note that the reaction called DRESS may develop weeks or months after your last dose. 
Reakcija, imenovana DRESS, se lahko pojavi šele več tednov ali mesecev po prejemu zadnjega odmerka.
Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells. 
Ipilimumab je zaviralec CTLA-4 (“CTLA-4 immune checkpoint inhibitor”), ki z zavrtjem T-celičnih inhibitornih signalov, ki se sprožijo preko CTLA-4, poveča število reaktivnih efektorskih celic T, kar mobilizira neposredni T-celični imunski odziv proti tumorskim celicam.
YERVOY is for intravenous use. 
Zdravilo YERVOY je namenjeno za intravensko uporabo.
Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a key regulator of T-cell activity. 
Citotoksični T limfocitni antigen 4 (CTLA-4; “Cytotoxic T-lymphocyte antigen-4”) je ključni regulator T-celične aktivnosti.
Median OS and estimated 1-year, 2-year, 3-year and 4-year survival rates are presented in Table 9. 
Mediana OS in ocenjeni deleži preživetja po 1-letu, 2-letih, 3-letih in 4-letih so prikazani v preglednici 9.
Moderate diarrhoea or colitis that either is not controlled with medical management or that persists (5-7 days) or recurs 
Prebavila: zmerna driska ali kolitis, ki kljub zdravljenju nista nadzorovana, vztrajata (5-7 dni) ali se ponavljata
Two patients treated with ipilimumab 10 mg/kg experienced a partial response, one of which was a durable response for more than 1 year. 
Pri dveh bolnikih, ki sta prejemala ipilimumab v odmerku 10 mg/kg, je bil dosežen delni odziv, pri enem trajni odziv, ki je trajal več kot 1 leto.
Randomisation was stratified by PD-L1 expression (≥ 5% vs. < 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system. 
Randomizacija je bila razslojena glede na ekspresijo PD-L1 (≥ 5 % v primerjavi z < 5 % ekspresije celične membrane tumorja), status BRAF in M stadij po kriterijih Ameriškega združenja za zdravljenje raka (AJCC - American Joint Committee on Cancer).
- inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis, Stevens-Johnson syndrome and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)). 
- vnetje kože, ki lahko napreduje do hude kožne reakcije (znana kot toksična epidermalna nekroliza, Stevens Johnsonov sindrom in reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS-Drug Reaction with Eosinophilia and Systemic Symptoms)).
Immune-related adverse reactions, which can be severe or life-threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems. 
Imunsko pogojeni neželeni učinki, ki so lahko resni ali življenjsko nevarni, lahko prizadenejo prebavila, jetra, kožo, živčevje, endokrine žleze ali druge organske sisteme.
You will be treated with YERVOY once every 3 weeks, for a total of 4 doses. 
Zdravilo YERVOY boste prejeli enkrat na vsake 3 tedne, vsega skupaj 4 odmerke.
“+” denotes a censored observation. 
“+” označuje krnjene podatke.
Patients with severe (Grade 3 or 4) endocrinopathy controlled with hormone replacement therapy may remain on therapy. 
Pri bolnikih s hudo (stopnja 3 ali 4) endokrinopatijo, ki je nadzorovana s hormonskim nadomestnim zdravljenjem, se zdravljenje lahko nadaljuje.
Rare cases of toxic epidermal necrolysis (TEN) (including Steven Johnson Syndrome) have been observed, some with fatal outcome. 
Poročali so o redkih primerih toksične epidermalne nekrolizie (TEN) (vključno s Stevens-Johnsonovim sindromom), v nekaterih primerih s smrtnimi izidom.
Solid organ transplant rejection 
Zavrnitev presadka čvrstega organa
Preparing the infusion: Take care to ensure aseptic handling when you prepare the infusion. 
Priprava raztopine za infundiranje: Pri pripravi raztopine za infundiranje morate zagotoviti aseptične pogoje.
The potential risk of treatment to the developing foetus is unknown. 
Možno tveganje za razvijajoči se plod ni znano.
Use of ipilimumab in combination with nivolumab in melanoma patients with rapidly progressing disease. 
Uporaba ipilimumaba v kombinaciji z nivolumabom pri bolnikih z melanomom s hitro napredujočo obliko bolezni
One female infant had unilateral renal agenesis of the left kidney and ureter, and one male infant had an imperforate urethra with associated urinary obstruction and subcutaneous scrotal edema. 
Ena samička se je skotila z enostransko agenezijo leve ledvice in sečevoda, en samček pa z atrezijo sečnice s posledično obstrukcijo urinskih poti in podkožnim edemom modnika.
- inflammation of the nerves that can lead to paralysis. 
- vnetje živcev, ki lahko napreduje do ohromelosti.
None had any infusion-related or peri-infusional hypersensitivity or anaphylactic reactions. 
Pri nobenem bolniku ni prišlo do pojava z infuzijo povezane ali peri-infuzijske preobčutljivosti ali anafilaktične reakcije.
YERVOY can be used for intravenous administration either: without dilution, after transfer to an infusion container using an appropriate sterile syringe; or after diluting to up to 5 times the original volume of concentrate (up to 4 parts of diluent to 1 part of concentrate). 
Zdravilo YERVOY se lahko aplicira intravensko: brez redčenja, po prenosu v infuzijski vsebnik z ustrezno sterilno injekcijsko brizgo, ali po redčenju do največ 5-kratnega začetnega volumna koncentrata (do 4 deli raztopine za redčenje na 1 del koncentrata).
Secondary efficacy endpoints of best overall response rate (BORR), stable disease (SD), disease control rate (DCR), and progression free survival (PFS) were based on mWHO criteria and determined by the investigator's assessment. 
Sekundarni opazovani dogodki učinkovitosti: najboljši celokupni delež odziva (BORR-best overall response rate), stabilna bolezen (SD-stable disease), delež nadzorovane bolezni (DCR-disease control rate) in preživetje brez napredovanja bolezni (PFS-progression free survival) so temeljili na modificiranih kriterijih SZO in so jih ovrednotili raziskovalci.
YERVOY in combination with nivolumab may cause changes in the results of tests carried out by your doctor. 
Zdravilo YERVOY v kombinaciji z nivolumabom lahko povzroči spremembe v rezultatih preiskav, ki jih bo opravil zdravnik.