FrancophonIA/ELRC3.0 huggingface dataset:
English: c included 4 drug-related deaths: 1 pneumonitis, 1 acute respiratory failure, 1 respiratory failure, and 1 cardiovascular failure.
Slovenian: Vključuje 4 z uporabo zdravila povezane smrtne izide: 1 pnevmonitis, 1 akutno respiratorno odpoved, 1 respiratorno odpoved in 1 kardiovaskularno odpoved.
English: Stevens-Johnson syndrome, vitiligo, erythema multiforme, alopecia, psoriasis
Slovenian: Stevens-Johnsonov sindrom, vitiligo, multiformni eritem, alopecija, psoriaza
English: What OPDIVO is and what it is used for
Slovenian: Kaj je zdravilo OPDIVO in za kaj ga uporabljamo
English: The safety and tolerability of nivolumab were investigated in a phase 1, open-label dose-escalation study in various tumour types, including malignant melanoma.
Slovenian: Varnost in prenašanje nivolumaba so raziskovali v odprti študiji 1. faze s povečevanjem odmerka pri različnih vrstah tumorjev, vključno z malignim melanomom.
English: Calculating the dose
Slovenian: Izračun odmerka
English: Not reached (2.9-20.5+)
Slovenian: ni dosežena (2,9-20,5+)
English: Patients had to have a Karnofsky Performance Score (KPS) ≥ 70%.
Slovenian: Bolniki so imeli oceno stanja telesne zmogljivosti po Karnofskem (KPS)  70 %.
English: Combination phase, every 3 weeks for 4 dosing cycles
Slovenian: Faza kombiniranega zdravljenja, vsake 3 tedne, 4 odmerki
English: All prescribers of OPDIVO must be familiar with the Physician Information and Management Guidelines.
Slovenian: Vsak zdravnik, ki predpisuje zdravilo OPDIVO, se mora seznaniti z izobraževalnim gradivom za zdravnike in smernicami za ukrepanje.
English: The median duration of response was not reached (range: 4.4-16.6+ months).
Slovenian: Mediana trajanja odziva ni bila dosežena (razpon: 4,4-16,6+ meseca).
English: Hyperacute GVHD, defined as acute GVHD occurring within 14 days after stem cell infusion, was reported in three patients (6%).
Slovenian: O hiperakutni GVHD, ki je bila opredeljena kot akutna GVHD, ki se je pojavila v 14 dneh po infundiranju matičnih celic, so poročali pri treh bolnikih (6 %).
English: Most patients present with asymptomatic increases in serum creatinine.
Slovenian: Večina bolnikov je imela le asimptomatsko zvišano vrednost serumskega kreatinina.
English: Sixteen percent of patients had received prior adjuvant therapy; the most common adjuvant treatment was interferon (9%).
Slovenian: 16 % bolnikov se je predhodno zdravilo adjuvantno, najpogosteje uporabljeno adjuvantno zdravilo pa je bil interferon (9 %).
English: What you need to know before you use OPDIVO
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo OPDIVO
English: With a minimum of 62.6 months follow-up, OS benefit remains consistently demonstrated across subgroups.
Slovenian: Pri spremljanju, ki je trajalo najmanj 62,6 meseca, je korist za celokupno preživetje ostala konsistentna po vseh podskupinah bolnikov.
English: Based on its pharmacodynamic properties, nivolumab is unlikely to affect the ability to drive and use machines.
Slovenian: Na osnovi farmakodinamičnih lastnosti nivolumaba je njegov vpliv na sposobnost vožnje in upravljanja strojev malo verjeten.
English: Due to the small numbers of patients in the subgroups, and exploratory nature of the analysis, no definitive conclusions can be drawn from these data.
Slovenian: Zaradi majhnega števila bolnikov v podskupini in eksplorativne narave analize ti podatki ne omogočajo definitivnih zaključkov.
English: Uncommon bronchitis bronchitis, aseptic meningitis
Slovenian: Občasni bronhitis bronhitis, aseptični meningitis
English: OPDIVO alone or in combination with ipilimumab may cause changes in the results of tests carried out by your doctor.
Slovenian: Zdravilo OPDIVO lahko samo ali v kombinaciji z ipilimumabom povzroči spremembe v izvidih preiskav, ki jih bo opravil zdravnik.
English: No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Slovenian: O posebnih razlikah v varnosti in učinkovitosti med starostniki (≥ 65 let) in mlajšimi bolniki (< 65 let) niso poročali.
English: Table 9: Best overall response, time and duration of response (CA209037)
Slovenian: Preglednica 9: Najboljši celokupni odziv, čas in trajanje odziva (študija CA209037)
English: All were considered not related to nivolumab by investigators except arrhythmia (atrial fibrillation, tachycardia and ventricular arrhythmia).
Slovenian: Po mnenju raziskovalcev nobeden ni bil povezan z uporabo nivolumaba, razen aritmije (atrijska fibrilacija, tahikardija in ventrikularna aritmija).
English: Rare cases of SJS and TEN some of them with fatal outcome have been observed.
Slovenian: Poročali so o redkih primerih SJS in TEN, nekateri od njih so se končali s smrtnim izidom.
English: Longer follow-up data from Cohort B (minimum 20.5 months) and efficacy of Cohort C from CA209205 are presented below in Table 22.
Slovenian: Podatki o daljšem obdobju spremljanja iz kohorte B (najmanj 20,5 meseca) in učinkovitosti iz kohorte C iz študije CA209205 so prikazani v preglednici 22.
English: Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed.
Slovenian: Poročali so o atipičnih odzivih (npr. prehodno povečanje velikosti tumorja ali pojav manjših novih sprememb na začetku zdravljenja v prvih nekaj mesecih, nato pa je sledilo zmanjšanje tumorja).
English: Anaemia is a composite term which includes, among other causes, haemolytic anaemia and autoimmune anaemia.
Slovenian: Anemija je sestavljen izraz, ki med drugimi vzroki vključuje hemolitično anemijo in avtoimunsko anemijo.
English: Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant related complications should be made case-by-case (see section 4.8).
Slovenian: Dokler ne bo na voljo več podatkov, je pri vsakem bolniku posebej treba skrbno ovrednotiti možne koristi HSCT in možno večje tveganje zapletov, povezanih s presaditvijo (glejte poglavje 4.8).
English: In the non-squamous NSCLC study (CA209057), the safety profile in patients with baseline renal or hepatic impairment was comparable to that in the overall population.
Slovenian: V študiji pri neploščatoceličnem NSCLC (študija CA209057) je bil varnostni profil pri bolnikih z okvaro ledvic ali jeter v izhodišču primerljiv z varnostnim profilom v celotni populaciji.
English: 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 8 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light].
Slovenian: 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 8 ur pri sobni temperaturi (20 °C do 25 °C) in sobni svetlobi].
English: The estimated 1-year survival rate was
Slovenian: Ocenjeni delež 1-letnega preživetja je znašal 41 %.
English: The final OS analysis occurred when all patients had a minimum follow-up of 28 months.
Slovenian: Končna analiza celokupnega preživetja je bila izvedena po najmanjšem obdobju spremljanja vseh bolnikov 28 mesecev.
English: 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 adjuvant treatment of melanoma, advanced melanoma and advanced RCC.
Slovenian: 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 adjuvantnem zdravljenju melanoma, napredovalem melanomu ali napredovalem karcinomu ledvičnih celic.
English: It is to be administered as an intravenous infusion over a period of 30 or 60 minutes depending on the dose (see Tables 1, 2 and 3).
Slovenian: Aplicirati ga je treba v obliki 30-minutne ali 60-minutne intravenske infuzije, odvisno od odmerka (glejte preglednice 1, 2 in 3).
English: If you stop using OPDIVO
Slovenian: Če ste prenehali uporabljati zdravilo OPDIVO
English: Metabolism and nutrition disorders Very common decreased appetite decreased appetite
Slovenian: Presnovne in prehranske motnje Zelo pogosti zmanjšanje apetita zmanjšanje apetita
English: Adjuvant treatment of melanoma
Slovenian: Adjuvantno zdravljenje melanoma
English: (95% CI)c nivolumab investigator's choice nivolumab investigator's choice nivolumab investigator's choice
Slovenian: (95 % IZ)c nivolumab izbira raziskovalca nivolumab izbira raziskovalca nivolumab izbira raziskovalca
English: ≥ 5 prior lines of systemic therapy
Slovenian: ≥ 5 predhodnih linij sistemskega zdravljenja Predhodno zdravljenje z obsevanjem
English: Other medicines and OPDIVO
Slovenian: Druga zdravila in zdravilo OPDIVO
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Slovenian: O posebnih razlikah v varnosti med starostniki (≥ 65 let) in mlajšimi bolniki (< 65 let) niso poročali.
English: Per the AJCC 8th edition, this corresponds to patients with lymph node involvement or metastases.
Slovenian: Po 8. izdaji kriterijev AJCC to ustreza bolnikom s prizadetimi bezgavkami ali z metastazami.
English: The primary endpoint was recurrence-free survival (RFS).
Slovenian: Primarni opazovani dogodek je bil preživetje brez ponovitve bolezni (RFS - recurrence-free survival).
English: Overall Survival (Months)
Slovenian: Celokupno preživetje (meseci)
English: You will receive treatment with OPDIVO in a hospital or clinic, under the supervision of an experienced doctor.
Slovenian: Način uporabe zdravila OPDIVO Zdravilo OPDIVO boste prejeli v bolnišnici pod nadzorom zdravnika z ustreznimi izkušnjami.
English: Preliminary results from the follow-up of patients with cHL undergoing allogeneic HSCT after previous exposure to nivolumab showed a higher than expected number of cases of acute graft-versus-host disease (GVHD) and transplant related mortality (TRM).
Slovenian: Preliminarni rezultati spremljanja bolnikov s cHL, pri katerih je bila opravljena alogenska HSCT po predhodnem zdravljenju z nivolumabom, so pokazali večje število primerov akutne bolezni presadka proti gostitelju (GVHD - graft-versus-host disease) od pričakovanega in umrljivost, povezano s presaditvijo (TRM - transplant related mortality).
English: Results of a post-hoc, exploratory multivariate analysis indicated that nivolumab-treated patients with poorer prognostic features and/or aggressive disease when combined with lower (e.g., < 50%) or no tumour PD-L1 expression may be at higher risk of death within the first 3 months.
Slovenian: Rezultati post-hoc eksploratorne analize multivariat so pokazali, da je pri bolnikih, ki so se zdravili z nivolumabom, in so imeli slabše prognostične dejavnike in/ali agresivno bolezen v kombinaciji z manjšo ekspresijo PD-L1 tumorja (npr. < 50 %) ali brez nje, tveganje za smrt v prvih 3 mesecih lahko večje.
English: Over 15 weeks of follow-up, patients treated with nivolumab exhibited stable PROs, while those assigned to investigator's choice therapy exhibited significant declines in functioning (e.g., physical, role, social) and health status as well as increased symptomatology (e.g., fatigue, dyspnoea, appetite loss, pain, sensory problems, social contact problems).
Slovenian: Pri spremljanju, ki je trajalo več kot 15 tednov, so bili izidi po poročanju bolnikov, ki so se zdravili z nivolumabom, stabilni, pri bolnikih, ki so bili dodeljeni na zdravljenje z zdravilom po izbiri raziskovalca, pa je bilo opazno pomembno pojemanje aktivnosti (npr. telesnih, družinskih, socialnih) in zdravstvenega stanja, pa tudi večjo bolezensko simptomatiko (npr. utrujenost, dispneja, izguba apetita, bolečina, senzorične težave, težave s socialnimi stiki).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours, malignant neoplasms of lymphoid tissue and malignant neoplasms of the central nervous system (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z nivolumabom za vse podskupine pediatrične populacije pri zdravljenju malignih solidnih tumorjev, malignih neoplazem limfatičnega tkiva in malignih neoplazem centralnega živčnega sistema (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The median duration of time from initial diagnosis to randomisation was 2.6 years in both the nivolumab and everolimus groups.
Slovenian: Mediano trajanje časa od začetne diagnoze do randomizacije je bilo 2,6 leta v obeh skupinah, v skupini z nivolumabom in skupini z everolimusom.
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: Posledica zasedenosti receptorja PD-1 z ligandoma PD-L1 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: Time to resolution ranged from 0.4 to 144.1+ weeks.
Slovenian: Čas do izboljšanja se je gibal v razponu od 0,4 do 144,1+ tedna.
English: Efficacy results based on investigator-assessed response rates at week 12 are presented in Table 10 below.
Slovenian: Rezultati učinkovitosti na osnovi deležev odziva po oceni raziskovalca v 12. tednu so predstavljeni v preglednici 10 v nadaljevanju.
English: Median duration of response was 13.2 months (95% CI: 8.2, NE)
Slovenian: Mediana trajanja odziva je znašala 13,2 meseca (95 % IZ: 8,2; NE).
English: Nivolumab in combination with ipilimumab (see section 4.2)
Slovenian: Nivolumab v kombinaciji z ipilimumabom (glejte poglavje 4.2)
English: Tumour PD-L1 expression was determined using the PD-L1 IHC 28-8 pharmDx assay.
Slovenian: Ekspresija PD-L1 tumorja je bila določena s testom PD-L1 IHC 28-8 pharmDx.
English: Factors associated with early deaths were poorer prognostic factors and/or more aggressive disease combined with low or no tumour PD-L1 expression (see section 5.1).
Slovenian: Dejavniki, povezani z zgodnejšo umrljivostjo, so bili slabši prognostični dejavniki in/ali agresivnejša bolezen v kombinaciji z manjšo ekspresijo PD-L1 tumorja ali brez nje (glejte poglavje 5.1).
English: Open-label phase 1 dose-escalation study (MDX1106-03)
Slovenian: Klinična študija 1. faze za ovrednotenje nivolumaba s povečevanjem odmerka (študija MDX1106-03)
English: Progression Free Survival Events (%)
Slovenian: Preživetje brez napredovanja bolezni Dogodki (%)
English: The Adverse Reaction Management Guide shall contain the following key elements:
Slovenian: Vodnik za ukrepanje v primeru pojava neželenih učinkov mora vsebovati naslednje ključne elemente:
English: The value of biomarkers to predict the efficacy of nivolumab and/or nivolumab + ipilimumab combination therapy should be further explored, specifically:
Slovenian: Dodatno je treba raziskati vrednost bioloških označevalcev za predvidevanje učinkovitosti nivolumaba in/ali nivolumaba + ipilimumaba pri kombiniranem zdravljenju, in sicer:
English: The diagnosis of myocarditis requires a high index of suspicion.
Slovenian: Pri diagnostiki miokarditisa je potrebna velika mera previdnosti.
English: There are no data on adjuvant treatment in patients with melanoma with the following risk factors (see sections 4.5 and 5.1
Slovenian: Pri bolnikih z melanomom z naslednjimi dejavniki tveganja ni podatkov o adjuvantnem zdravljenju (glejte poglavji 4.5 in 5.1):
English: It is available in packs containing either 1 vial of 4 mL, 1 vial of 10 mL or 1 vial of 24 mL.
Slovenian: Zdravilo je na voljo v pakiranjih, ki vsebujejo 1 vialo s 4 ml zdravila, 1 vialo z 10 ml zdravila ali 1 vialo s 24 ml zdravila.
English: Resolution occurred in 117 patients (42.9%).
Slovenian: Do izboljšanja je prišlo pri 117 bolnikih (42,9 %).
English: Patients with investigator-assessed primary site of oropharyngeal cancer were tested for HPV (determined by p16 immunohistochemistry [IHC]).
Slovenian: Bolnike s primarnim mestom raka v ustnem delu žrela po oceni raziskovalca so testirali na HPV (imunohistokemično [IHC] določanje p16).
English: Melanoma (advanced or adjuvant treatment)
Slovenian: Melanom (napredovali melanom ali adjuvantno zdravljenje)
English: 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.
Slovenian: Ker se monoklonska protitelesa ne presnavljajo z encimi citokroma P450 (CYP) ali drugimi presnovnimi encimi, ni pričakovati, da bi zaviranje ali indukcija teh encimov zaradi sočasne uporabe drugih zdravil vplivala na farmakokinetiko nivolumaba.
English: Pre-study tumour tissue specimens were systematically collected prior to randomisation in order to conduct pre-planned analyses of efficacy according to tumour PD-L1 expression.
Slovenian: Pred randomizacijo so sistematično zbrali vzorce tumorskega tkiva z namenom izvedbe vnaprej predvidenih analiz učinkovitosti glede na ekspresijo PD-L1 tumorja.
English: Most immune-related adverse reactions improved or resolved with appropriate management, including initiation of corticosteroids and treatment modifications (see section 4.2).
Slovenian: Večina imunsko pogojenih neželenih učinkov se je izboljšala ali izzvenela z ustreznim zdravljenjem, vključno z uvedbo kortikosteroidov, in prilagoditvami zdravljenja (glejte poglavje 4.2).
English: No clear cut off for PD-L1 expression can reliably be established when considering the relevant endpoints of tumour response and PFS and OS.
Slovenian: Jasne mejne vrednosti ekspresije PD-L1 ni bilo mogoče ugotoviti, če upoštevamo relevantne opazovane dogodke odziva tumorja in PFS ter OS.
English: Rapid tapering may lead to worsening or recurrence of the adverse reaction.
Slovenian: Pri hitrem zmanjševanju odmerka se neželeni učinek lahko poslabša ali ponovi.
English: Complications of stem cell transplant that uses donor stem cells (allogeneic) after treatment with OPDIVO.
Slovenian: Zapleti po presaditvi matičnih celic z uporabo darovalčevih matičnih celic (alogenska presaditev) po zdravljenju z zdravilom OPDIVO.
English: Patients who had not received prior systemic anticancer therapy for unresectable or metastatic melanoma were enrolled.
Slovenian: Vključeni so bili bolniki, ki predhodno niso prejemali sistemskega protitumorskega zdravljenja zaradi neoperabilnega ali metastatskega melanoma.
English: • patients with prior therapy for melanoma (except patients with surgery, adjuvant radiotherapy after neurosurgical resection for lesions of the central nervous system, and prior adjuvant interferon completed ≥ 6 months prior to randomisation),
Slovenian: • bolniki s predhodno zdravljenim melanomom (razen bolniki s predhodnim kirurškim posegom, adjuvantno radioterapijo po nevrokirurški odstranitvi sprememb v osrednjem živčevju in predhodnim adjuvantnim zdravljenjem z interferonom, dokončanim ≥ 6 mesecev pred randomizacijo),
English: It is very important for you to keep all your appointments to receive OPDIVO.
Slovenian: Zelo pomembno je, da prejmete vse predvidene odmerke zdravila OPDIVO.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC
English: Not Reached (1.9+, 12.0+)
Slovenian: ni dosežena (1,9+; 12,0+)
English: There was no statistically significant difference between nivolumab and chemotherapy in the final OS analysis.
Slovenian: Pri končni analizi celokupnega preživetja ni bilo statistično pomembne razlike med nivolumabom in kemoterapijo.
English: • patients with prior autoimmune disease, and any condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications,
Slovenian: • bolniki s predhodno avtoimunsko boleznijo in bolniki s katerim koli stanjem, pri katerem je bilo potrebno sistemsko zdravljenje bodisi s kortikosteroidi (≥ 10 mg prednizona ali njegovega ekvivalenta na dan) bodisi z drugimi zdravili za sistemsko zaviranje imunske odzivnosti,
English: With a minimum follow-up of 11.4 months, the trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with investigator's choice.
Slovenian: Pri spremljanju, ki je trajalo najmanj 11,4 meseca, je preskušanje pokazalo statistično pomembno izboljšanje celokupnega preživetja pri bolnikih, randomiziranih na nivolumab, v primerjavi z zdravilom po izbiri raziskovalca.
English: A higher proportion of patients experienced death within the first 3 months in the nivolumab arm (59/292, 20.2%) as compared to the docetaxel arm (44/290, 15.2%).
Slovenian: V skupini z nivolumabom je v prvih 3 mesecih umrl večji delež bolnikov (59/292, 20,2 %) kot v skupini z docetakselom (44/290, 15,2 %).
English: Rare (may affect up to 1 in 1000 people) Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis)
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) hudo luščenje kože, ki se lahko konča tudi s smrtjo (toksična epidermalna nekroliza)
English: Comparable to the overall population, median duration of response was increased with nivolumab vs. docetaxel for patients with no PD-L1 expression (18.3 months vs. 5.6 months) and for patients with PD-L1 expression (16.0 months vs. 5.6 months).
Slovenian: V primerjavi s celokupno populacijo je bilo mediano trajanje odziva daljše pri nivolumabu v primerjavi z docetakselom pri bolnikih brez ekspresije PD-L1 (18,3 meseca v primerjavi s 5,6 meseca) in pri bolnikih z ekspresijo PD-L1 (16,0 meseca v primerjavi s 5,6 meseca).
English: Each vial contains either 40 mg (in 4 mL), 100 mg (in 10 mL) or 240 mg (in 24 mL) of nivolumab.
Slovenian: Ena viala vsebuje 40 mg (v 4 ml), 100 mg (v 10 ml) ali 240 mg (v 24 ml) nivolumaba.
English: CR+PR, confidence interval based on the Clopper and Pearson method
Slovenian: b popolni odziv (CR) + delni odziv (PR), interval zaupanja na osnovi Clopper-Pearsonove metode.
English: From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo infundirati ali razredčiti in infundirati takoj po odprtju viale.
English: In subgroup analyses, survival benefit compared to docetaxel was not shown for patients who were never-smokers or whose tumours harboured EGFR activating mutations; however, due to the small numbers of patients, no definitive conclusions can be drawn from these data.
Slovenian: Pri analizah po podskupinah pri bolnikih, ki niso nikoli kadili ali katerih tumor je imel EGFR aktivirajoče mutacije, niso ugotovili koristi za preživetje v primerjavi z docetakselom, vendar pa zaradi majhnega števila bolnikov, ti podatki ne omogočajo definitivnih zaključkov.
English: There was a dosedependent increase in foetal losses and increased neonatal mortality beginning in the third trimester.
Slovenian: Poročali so o od odmerka odvisnem povečanju izgub plodov in o večji neonatalni umrljivosti od tretjega trimesečja dalje.
English: OPDIVO infusion must be completed within 24 hours of preparation.
Slovenian: Raztopina zdravila OPDIVO, pripravljena za infundiranje Infundiranje zdravila OPDIVO je treba dokončati v 24 urah po pripravi.
English: Quantifiable tumour PD-L1 expression was measured in 79% of patients in the nivolumab group and 77% of patients in the docetaxel group.
Slovenian: Merljiva ekspresija PD-L1 tumorja je bila izmerjena pri 79 % bolnikov v skupini z nivolumabom in 77 % bolnikov v skupini z docetakselom.