FrancophonIA/ELRC3.0 huggingface dataset:
English: OPDIVO is a medicine used to treat: advanced melanoma (a type of skin cancer) in adults melanoma after complete resection in adults (treatment after surgery is called adjuvant therapy) advanced non-small cell lung cancer (a type of lung cancer) in adults advanced renal cell carcinoma (advanced kidney cancer) in adults classical Hodgkin lymphoma that has come back after or has not responded to previous therapies, including an autologous stem-cell transplant (a transplant of your own blood-producing cells) in adults advanced cancer of the head and neck in adults advanced urothelial carcinoma (bladder and urinary tract cancer) in adults.
Slovenian: Zdravilo OPDIVO uporabljamo za zdravljenje: napredovalega melanoma (vrsta kožnega raka) pri odraslih melanoma po popolni kirurški odstranitvi pri odraslih (zdravljenje po kirurškem posegu imenujemo adjuvantno zdravljenje) napredovalega nedrobnoceličnega pljučnega raka (vrsta pljučnega raka) pri odraslih napredovalega karcinoma ledvičnih celic (napredovalega ledvičnega raka) pri odraslih klasičnega Hodgkinovega limfoma, ki se je ponovil ali se ni odzval na predhodno zdravljenje, vključno z avtologno presaditvijo matičnih celic (presaditev telesu lastnih krvotvornih celic) pri odraslih napredovalega raka glave in vratu pri odraslih napredovalega urotelijskega karcinoma (raka sečnega mehurja in sečil) pri odraslih.
English: If myocarditis is suspected, prompt initiation of a high dose of steroids (prednisone 1 to 2 mg/kg/day or methylprednisolone 1 to 2 mg/kg/day) and prompt cardiology consultation with diagnostic workup according to current clinical guidelines should be initiated.
Slovenian: V primeru suma na miokarditis je treba takoj uvesti zdravljenje z visokimi odmerki kortikosteroidov (prednizon v odmerku 1 do 2 mg/kg/dan ali metilprednizolon v odmerku 1 do 2 mg/kg/dan), se nemudoma posvetovati s kardiologom in opraviti diagnostične preiskave v skladu s trenutnimi kliničnimi smernicami.
English: following nivolumab therapy' o Potential risk of ‘Risk of GVHD with nivolumab after allogeneic HSCT'
Slovenian: (GVHD) in umrljivostjo, povezano s presaditvijo' o Možno tveganje za ‘Tveganje za GVHD pri zdravljenju z nivolumabom po alogenski
English: Forty-two percent of patients were BRAF V600 mutation positive while 45% were BRAF wild type and 13% BRAF were status unknown.
Slovenian: Dvainštirideset bolnikov je bilo pozitivnih za mutacijo BRAF V600, 45 % bolnikov je imelo divji tip BRAF, pri 13 % bolnikov pa status BRAF ni bil znan.
English: Table 7 presents the percentage for immune-related adverse reactions who were permanently discontinued from treatment by dosing regimen.
Slovenian: V preglednici 7 so glede na režim zdravljenja predstavljeni deleži bolnikov z imunsko pogojenimi neželenimi učinki, pri katerih je bilo zdravljenje trajno ukinjeno.
English: OPDIVO should not be infused concomitantly in the same intravenous line with other medicinal products.
Slovenian: Zdravila OPDIVO se ne sme infundirati sočasno z drugimi zdravili preko iste intravenske linije.
English: OS results from this follow-up analysis are shown in Figure 5 (all randomised), Figure 6 (at the tumour PD-L1 1% cut off), and Table 11 (at the tumour PD-L1 5% cut off).
Slovenian: Rezultati celokupnega preživetja iz te analize spremljanja so prikazani na sliki 5 (vsi randomizirani bolniki), sliki 6 (pri mejni vrednosti PD-L1 tumorja 1 %) in v preglednici 11 (pri mejni vrednosti PD-L1 tumorja 5 %).
English: To further investigate the value of biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other genomic-based 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, expression of components of antigen-presentation complexes and/or other inhibitory checkpoint receptors/ligands within tumour, etc.) as predictive of nivolumab + ipilimumab combination therapy efficacy in the context of melanoma studies CA209038, CA209067, or CA209069.
Slovenian: Dodatno raziskati še vrednost drugih bioloških označevalcev poleg vrednosti statusa ekspresije PD-L1 na membrani tumorskih celic z IHC (npr. druge metode/testi na osnovi genoma 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, ekspresije komponent antigen-predstavitvenih kompleksov in/ali drugih zaviralnih receptorjev/ligandov kontrolnih točk v tumorju ipd.) kot napovednika učinkovitosti nivolumaba + ipilimumaba pri kombiniranem zdravljenju v kontekstu študij pri melanomu CA209038, CA209067 ali CA209069.
English: Grade 2 adrenal insufficiency Grade 3 diabetes
Slovenian: Insuficienca nadledvičnih žlez stopnje 2 Diabetes stopnje 3
English: Among 128 patients who discontinued nivolumab in combination with ipilimumab due to adverse reaction after 18 months of follow-up, median PFS was 16.7 months (95% CI: 10.2, NA).
Slovenian: Pri 128 bolnikih, pri katerih je bilo zdravljenje z nivolumabom v kombinaciji z ipilimumabom zaradi neželenih učinkov po 18 mesecih spremljanja prekinjeno, je mediana PFS znašala 16,7 meseca (95 % interval zaupanja: 10,2; NP).
English: Nivolumab as monotherapy (see section 4.2)
Slovenian: Nivolumab v monoterapiji (glejte poglavje 4.2)
English: c p-value is compared to alpha 0.002 in order to achieve statistical significance.
Slovenian: c p-vrednost v primerjavi z alfa 0,002 za dosego statističnega pomena.
English: Uncommon psoriasis
Slovenian: Občasni psoriaza
English: Hepatic veno-occlusive disease occurred in one patient, who died of GVHD and multi-organ failure.
Slovenian: Pri enem bolniku so poročali o venookluzivni bolezni jeter, ki je umrl zaradi GVHD in odpovedi več organov.
English: ** nivolumab in combination with ipilimumab for the first 4 doses then followed by nivolumab monotherapy in RCC.
Slovenian: ** nivolumab v kombinaciji z ipilimumabom pri prvih 4 odmerkih in nato nivolumab v monoterapiji pri zdravljenju RCC.
English: Post authorisation efficacy study (PAES): In order to further elucidate the contribution of ipilimumab to the efficacy and toxicity of the combination regimen of nivolumab and ipilimumab, the MAH should conduct and submit the results of a randomised, clinical study comparing the efficacy and safety of the combination of nivolumab and ipilimumab to nivolumab monotherapy in previously untreated adult patients with intermediate/poorrisk advanced renal cell carcinoma and with an appropriate spectrum of PDL1 expression levels.
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): Da bi podrobneje pojasnili prispevek ipilimumaba k učinkovitosti in toksičnosti kombiniranega režima zdravljenja z nivolumabom in ipilimumabom mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate randomizirane, klinične študije, ki učinkovitost in varnost kombiniranega zdravljenja z nivolumabom in ipilimumabom primerja z zdravljenjem z nivolumabom v monoterapiji pri predhodno nezdravljenih odraslih bolnikih z napredovalim karcinomom ledvičnih celic s srednje ugodnim ali slabim prognostičnim obetom in z ustreznim spektrom ravni ekspresije PD-L1.
English: Twenty-two percent of patients had tumours that tested BRAF mutation positive and 50% of patients had tumours that were considered PD-L1 positive.
Slovenian: 22 % bolnikov je imelo tumor, ki je bil pri testiranju pozitiven za mutacijo BRAF, 50 % bolnikov pa je imelo tumor, ki so ga označili kot PD-L1 pozitivnega.
English: Solid organ transplant rejection.
Slovenian: zavrnitev presadka čvrstega organa.
English: Patients were enrolled regardless of their tumour PD-L1 or human papilloma virus (HPV) status.
Slovenian: Bolnike so vključili ne glede na status PD-L1 tumorja ali status humanega virusa papiloma (HPV).
English: PFS rate at 12 months and 95% CI: 18% (14, 23)
Slovenian: Delež PFS v 12. mesecu in 95 % IZ: 18 % (14; 23)
English: Nivolumab with ipilimumab was continued beyond progression in 29% of patients.
Slovenian: Po napredovanju bolezni se je zdravljenje z nivolumabom v kombinaciji z ipilimumabom nadaljevalo pri 29 % bolnikov.
English: The median duration of time from initial diagnosis to randomisation was 0.4 years in both the nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg and sunitinib groups.
Slovenian: Mediana trajanja časa od začetne diagnoze do randomizacije je bila 0,4 leta v obeh skupinah, v skupini z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg, in v skupini s sunitinibom.
English: Baseline characteristics were balanced between groups except for the proportions of patients who had a history of brain metastasis (19% and 13% in the nivolumab group and chemotherapy group, respectively) and patients with LDH greater than ULN at baseline (51% and 35%, respectively).
Slovenian: Izhodiščne lastnosti so bile med skupinama uravnotežene, razen za delež bolnikov, ki so imeli zasevke v možganih (19 % bolnikov v skupini z nivolumabom in 13 % bolnikov v skupini s kemoterapijo) in delež bolnikov z izhodiščno vrednostjo LDH, večjo od ZMN (51 % bolnikov v skupini z nivolumabom in 35 % bolnikov v skupini s kemoterapijo).
English: Grade 3 or 4 elevation in AST, ALT, or total bilirubin
Slovenian: Zvišanje vrednosti AST, ALT ali skupnega bilirubina stopnje 3 ali 4
English: Treatment of advanced melanoma
Slovenian: Zdravljenje napredovalega melanoma
English: 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.
Slovenian: Randomizacija je bila stratificirana 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).
English: Overall survival Events Hazard ratioa (95% CI) p-valueb Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Rate (95% CI) at 18 months Progression-free survival Events Hazard ratio 95% CI p-value Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Confirmed objective responsec (95% CI) Odds ratio (95% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Median time to response Months (range) Median duration of response Months (range)
Slovenian: Celokupno preživetje Dogodki Razmerje ogroženostia (95 % IZ) p-vrednostb Mediana (95 % IZ) (meseci) Delež (95 % IZ) v 6. mesecu Delež (95 % IZ) v 12. mesecu Delež (95 % IZ) v 18. mesecu Preživetje brez napredovanja bolezni Dogodki Razmerje ogroženosti 95 % IZ p-vrednost Mediana (95 % IZ) (meseci) Delež (95 % IZ) v 6. mesecu Delež (95 % IZ) v 12. mesecu Potrjeni objektivni odzivc (95 % IZ) Razmerje obetov (95 % IZ) Popolni odziv (CR) Delni odziv (PR) Stabilna bolezen (SD) Mediana časa do odziva Meseci (razpon) Mediana trajanja odziva Meseci (razpon)
English: h p-value is compared to alpha 0.009 in order to achieve statistical significance.
Slovenian: h p-vrednost v primerjavi z alfa 0,009 za dosego statističnega pomena.
English: Overall survival could be accompanied by an improvement over time in disease related symptoms and non-disease specific QoL as assessed using valid and reliable scales in the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) and the EuroQoL EQ-5D.
Slovenian: Celokupno preživetje bi lahko spremljalo izboljšanje z boleznijo povezanih simptomov in za bolezen nespecifične kakovosti življenja, kar je bilo ovrednoteno s pomočjo validiranih in zanesljivih lestvic FKSI-DRS (Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease
English: The active substance is nivolumab.
Slovenian: Učinkovina je nivolumab.
English: Additional safety and descriptive efficacy data are available from study CA209374, an open-label Phase 3b/4 safety study of nivolumab monotherapy (treated with 240 mg every 2 weeks) for the treatment of patients with advanced or metastatic RCC (n = 142), including 44 patients with non-clear cell histology.
Slovenian: Iz študije CA209374, odprte študije o varnosti uporabe nivolumaba v monoterapiji (zdravljenje z odmerkom 240 mg vsaka 2 tedna) faze 3b/4, so na voljo dodatni podatki o varnosti in opisni podatki o učinkovitosti pri zdravljenju bolnikov z napredovalim ali metastatskim karcinomom ledvičnih celic (n = 142), vključno s 44 bolniki z nejasno celično histologijo.
English: When administered in combination with ipilimumab, the CL of nivolumab increased by 20% in the presence of anti-nivolumab antibodies and the CL of ipilimumab increased by 5.7% in the presence of anti-ipilimumab antibodies.
Slovenian: Pri uporabi v kombinaciji z ipilimumabom se je očistek nivolumaba v prisotnosti protiteles proti nivolumabu povečal za 20 %, očistek ipilimumaba pa se je v prisotnosti protiteles proti ipilimumabu povečal za 5,7 %.
English: Baseline characteristics were balanced across the three treatment groups.
Slovenian: Izhodiščne lastnosti so bile med tremi skupinami zdravljenja uravnotežene.
English: Squamous Cell Cancer of the Head and Neck (SCCHN) OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1).
Slovenian: Ploščatocelični karcinom glave in vratu (SCCHN - squamous cell cancer of the head and neck) Zdravilo OPDIVO je v monoterapiji indicirano za zdravljenje ponovljenega ali metastatskega ploščatoceličnega karcinoma glave in vratu pri odraslih, pri katerih je bolezen napredovala med zdravljenjem ali po zdravljenju na osnovi platine (glejte poglavje 5.1).
English: Excipients: sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Slovenian: Pomožne snovi: natrijev citrat dihidrat, natrijev klorid, manitol (E421), pentetska kislina, polisorbat 80, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
English: Administer the OPDIVO infusion intravenously over a period of 30 or 60 minutes depending on the dose.
Slovenian: OPDIVO raztopino za infundiranje morate aplicirati v obliki 30-minutne ali 60-minutne intravenske infuzije, odvisno od odmerka.
English: Subsequent immunotherapy (including anti-PD1 therapy, anti-CTLA-4 antibody, or other immunotherapy) was received by 14.6%, 29.1%, and 44.1% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Slovenian: V skupini s kombiniranim zdravljenjem se je naknadno z imunoterapijo (vključno z antiPD1, anti-CTLA-4 protitelesi ali drugo obliko imunoterapije) zdravilo 14,6 % bolnikov, v skupini zdravljenja z nivolumabom v monoterapiji 29,1 % bolnikov, v skupini zdravljenja z ipilimumabom pa 44,1 % bolnikov.
English: Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the treatment groups.
Slovenian: Pri bolnikih z merljivo ekspresijo PD-L1 tumorja je bila porazdelitev bolnikov po skupinah zdravljenja uravnotežena.
English: Results from post-hoc, exploratory analyses indicate that in patients with low (e.g. <1%) to no tumour PD-L1 expression, other patient characteristics (e.g. liver metastases, visceral metastases, baseline haemoglobin <10g/dL and ECOG performance status = 1) might contribute to the clinical outcome.
Slovenian: Rezultati post-hoc eksploratornih analiz kažejo, da lahko pri bolnikih z majhno ekspresijo PDL1 tumorja (npr. < 1 %) do brez nje k kliničnemu izidu pripomorejo druge lastnosti bolnika (npr. metastaze v jetrih, visceralne metastaze, vrednost hemoglobina <10 g/dl v izhodišču in stanje telesne zmogljivosti po lestvici ECOG = 1).
English: 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
Slovenian: Objektivni odziv (95 % IZ) Razmerje obetov (vs. ipilimumab) (99,5 % IZ) Popolni odziv (CR) Delni odziv (PR) Stabilna bolezen (SD) Trajanje odziva Mediana (razpon), meseci ni dosežena
English: Rare toxic epidermal necrolysisa,f, StevensJohnson syndromef Musculoskeletal and connective tissue disorders Very common arthralgia musculoskeletal paing, arthralgia
Slovenian: Redki toksična epidermalna nekrolizaa,f, Stevens-Johnsonov sindromf Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti artralgija mišično-skeletna bolečinag, artralgija
English: docetaxel (n = 137)
Slovenian: docetaksel (n = 137)
English: • Relevant information (e.g., seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns: o Immune-related pneumonitis o Immune-related colitis o Immune-related hepatitis o Immune-related nephritis and renal dysfunction o Immune-related endocrinopathies o Immune-related skin adverse reactions o Other immune-related ARs o Potential risk of ‘Complications including acute graft-versus-host disease (GVHD) and transplant related mortality of allogeneic Haematopoietic Stem Cell Transplant (HSCT)
Slovenian: • Relevantne podatke (npr. o resnosti, jakosti, pogostnosti, času pojava, reverzibilnosti neželenega učinka, kot je primerno) za naslednja varnostna tveganja: o Imunsko pogojeni pnevmonitis o Imunsko pogojeni kolitis o Imunsko pogojeni hepatitis o Imunsko pogojeni nefritis in okvara delovanja ledvic o Imunsko pogojene endokrinopatije o Imunsko pogojeni neželeni učinki na kožo o Drugi imunsko pogojeni neželeni učinki o Možno tveganje za ‘zaplete alogenske presaditve krvotvornih matičnih celic (HSCT) po zdravljenju z nivolumabom, vključno z akutno boleznijo presadka proti gostitelju
English: Minimum follow-up for the analysis of ORR was 28 months.
Slovenian: Najmanjše obdobje spremljanja za analizo deleža objektivnega odziva je znašalo 28 mesecev.
English: Nivolumab or nivolumab in combination with ipilimumab is associated with immune-related adverse reactions.
Slovenian: Uporaba nivolumaba ali nivolumaba v kombinaciji z ipilimumabom je bila povezana s pojavom imunsko pogojenih neželenih učinkov.
English: f p-value is compared to alpha 0.001 in order to achieve statistical significance.
Slovenian: f p-vrednost v primerjavi z alfa 0,001 za dosego statističnega pomena.
English: Table 15: ORR based on response evaluable patients - total and by subgroup (CA209171) Results
Slovenian: Preglednica 15: Delež objektivnega odziva (ORR) na osnovi bolnikov z ovrednotenim odzivom - skupaj in po podskupinah bolnikov (študija CA209171)
English: In an exploratory post-hoc analysis using a non-validated assay, both tumour cell PD-L1 expression and tumour-associated immune cell (TAIC) PD-L1 expression were analysed in relation to the magnitude of treatment effect of nivolumab compared to investigator's choice.
Slovenian: V eksplorativni post-hoc analizi so z nevalidirano analizo analizirali ekspresijo PD-L1 tumorske celice in ekspresijo PD-L1 s tumorjem povezane imunske celice (TAIC; tumour-associated immune cell) v povezavi z obsegom učinka zdravljenja z nivolumabom v primerjavi z zdravljenjem z zdravilom po izbiri raziskovalca.
English: The PRO data should be interpreted in the context of the open-label study design and therefore taken cautiously.
Slovenian: Podatke o izidih zdravljenja po poročanju bolnikov je treba interpretirati v kontekstu odprte zasnove študije in jih zato obravnavati previdno.
English: All patients had either progressed, were censored, or lost to follow-up
Slovenian: Bolezen je bila pri vseh bolnikih v napredovanju ali pa so bili podatki krnjeni oziroma bolniki izgubljeni za spremljanje a
English: The following immune-related adverse reactions were reported in less than 1% of patients treated with nivolumab monotherapy or nivolumab in combination with ipilimumab in clinical trials across doses and tumour types: pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barré syndrome, myasthenia gravis, myasthenic syndrome, aseptic meningitis, encephalitis, gastritis, sarcoidosis, duodenitis, myositis, myocarditis, and rhabdomyolysis.
Slovenian: O naslednjih imunsko pogojenih neželenih učinkih so poročali pri manj kot 1 % bolnikov, ki so se v kliničnih preskušanjih zdravili z nivolumabom v monoterapiji ali z nivolumabom v kombinaciji z ipilimumabom v različnih odmerkih in zaradi različnih vrst tumorjev: pankreatitis, uveitis, demielinizacija, avtoimunska nevropatija (vključno s parezo obraznega in abducentnega živca), Guillain-Barréjev sindrom, miastenija gravis, miastenijski sindrom, aseptični meningitis, encefalitis, gastritis, sarkoidoza, duodenitis, miozitis, miokarditis in rabdomioliza.
English: Table 23: Efficacy results (CA209141)
Slovenian: Preglednica 23: Rezultati učinkovitosti (študija CA209141)
English: Patients in the nivolumab monotherapy arm received nivolumab 3 mg/kg every 2 weeks.
Slovenian: Bolniki v skupini zdravljenja z nivolumabom v monoterapiji so nivolumab prejemali v odmerku 3 mg/kg vsaka 2 tedna.
English: Progression Free Survival per Investigator (Months) Number of Subjects at Risk Nivolumab + Ipilimumab
Slovenian: Preživetje brez napredovanja bolezni po oceni raziskovalca (meseci) Število ogroženih oseb nivolumab + ipilimumab nivolumab ipilimumab
English: Hypophysitis occurred in 4.0% (22/547) of patients.
Slovenian: Vnetje hipofize se je pojavilo pri 4,0 % (22/547) bolnikov.
English: The other ingredients are sodium citrate dihydrate, sodium chloride (see section 2 "OPDIVO contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Slovenian: Druge sestavine zdravila so natrijev citrat dihidrat, natrijev klorid (glejte poglavje 2 “Zdravilo OPDIVO vsebuje natrij”), manitol (E421), pentetska kislina, polisorbat 80, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
English: In a post-hoc analysis of the 80 patients in CA209205 Cohort B, 37 had no response to prior brentuximab vedotin treatment.
Slovenian: V post-hoc analizi 80 bolnikov iz kohorte B študije CA209205 pri 37 bolnikih odziv na predhodno zdravljenje z brentuksimabom vedotinom ni bil dosežen.
English: * nivolumab in combination with ipilimumab for the first 4 doses then followed by nivolumab monotherapy in melanoma.
Slovenian: * nivolumab v kombinaciji z ipilimumabom pri prvih 4 odmerkih in nato nivolumab v monoterapiji pri zdravljenju melanoma.
English: The recommended dose of OPDIVO is either nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks (see section 5.1) depending on the indication, as presented in Table 1.
Slovenian: Priporočeni odmerek zdravila OPDIVO je bodisi 240 mg nivolumaba vsaka 2 tedna ali 480 mg vsake 4 tedne (glejte poglavje 5.1), odvisno od indikacije, kot je prikazano v preglednici 1.
English: Of the 811 treated patients, 103 (13%) had an ECOG performance score of 2, 686 (85%) were < 75 years old and 125 (15%) were ≥ 75 years old.
Slovenian: Od 811 zdravljenih bolnikov so 103 bolniki (13 %) imeli stanje telesne zmogljivosti po lestvici ECOG 2, 686 bolnikov (85 %) je bilo mlajših od 75 let, 125 bolnikov (15 %) pa starih 75 let ali starejših.
English: Infections of the upper respiratory tract
Slovenian: Pogosti okužba zgornjih dihal
English: 61 (64%) M 34 (36%) F
Slovenian: 61 (64 %) M 34 (36 %) Ž
English: The benefit of treatment with nivolumab versus the possible risk should be considered in these patients (see section 4.8).
Slovenian: Pri teh bolnikih je potrebno ovrednotiti razmerje med možno koristjo in tveganjem zdravljenja z nivolumabom (glejte poglavje 4.8).
English: Classical Hodgkin Lymphoma
Slovenian: Klasični Hodgkinov limfom
English: NR (32.72, NR) NR (39.06, NR)
Slovenian: ND (32,72; ND) ND (39,06; ND)
English: Human IgG4 is known to cross the placental barrier and nivolumab is an IgG4; therefore, nivolumab has the potential to be transmitted from the mother to the developing foetus.
Slovenian: Nivolumab je IgG4 in kot tak lahko preide iz matere na razvijajoči se plod.