FrancophonIA/ELRC3.0 huggingface dataset:
English: After administration of the nivolumab dose, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Slovenian: Po končanem infundiranju odmerka nivolumaba infuzijsko linijo splaknite z 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje ali s 5-odstotno (50 mg/ml) raztopino glukoze za injiciranje.
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for life-threatening hyperthyroidism or hypothyroidism.
Slovenian: V primeru življenje ogrožajočega hipertiroidizma ali hipotiroidizma je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom trajno ukiniti.
English: The majority of cases were Grade 1 or 2 in severity reported in 3.5% (91/2578) and 1.2% (32/2578) of patients respectively.
Slovenian: O primerih stopnje 1 so poročali pri 3,5 % (91/2.578) bolnikov, o primerih stopnje 2 pa pri 1,2 % (32/2.578) bolnikov.
English: Withhold dose(s) until symptoms resolve and management with corticosteroids is complete
Slovenian: Aplikacijo odmerka (odmerkov) zadržite, dokler simptomi ne izzvenijo in zdravljenje s kortikosteroidi ni končanoc.
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Slovenian: Pri zdravljenju z nivolumabom v monoterapiji ali zdravljenju z nivolumabom v kombinaciji z ipilimumabom so poročali o hudi pljučnici ali bolezni pljučnega intersticija, vključno s smrtnimi primeri (glejte poglavje 4.8).
English: Patients with a baseline performance score ≥ 2, active brain metastases or leptomeningeal metastases, autoimmune disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
Slovenian: Bolnike z izhodiščno oceno telesne zmogljivosti ≥ 2, aktivnimi zasevki v možganih ali zasevki v leptomeningah, avtoimunsko boleznijo ter bolnike, ki so se pred vključitvijo v študijo zdravili z zdravili za sistemsko zaviranje imunske odzivnosti, so iz ključnih kliničnih preskušanj nivolumaba ali nivolumaba v kombinaciji z ipilimumabom izključili (glejte poglavji 4.5 in 5.1).
English: Common increased total bilirubin, hypoglycaemia, hypermagnesaemia, hypernatraemia, weight decreased a
Slovenian: Pogosti zvišanje vrednosti skupnega bilirubina, hipoglikemija, hipermagneziemija, hipernatriemija, zmanjšanje telesne mase a
English: Probability of Recurrence-Free Survival
Slovenian: Verjetnost preživetja brez ponovitve bolezni
English: Resolution occurred in 428 patients (63.8%) with a median time to resolution of 17.1 weeks
Slovenian: Do izboljšanja je prišlo pri 428 bolnikih (63,8 %), mediani čas do izboljšanja pa je znašal 17,1 tedna (0,1-150,0+).
English: Patients with a baseline performance score ≥2, active brain metastases or leptomeningeal metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of urothelial carcinoma (see sections 4.5 and 5.1).
Slovenian: Bolnike z izhodiščno oceno telesne zmogljivosti ≥ 2, aktivnimi zasevki v možganih ali zasevki v leptomeningah, aktivno avtoimunsko boleznijo ali zdravstvenimi stanji, ki so zahtevala zdravljenje z zdravili za sistemsko zaviranje imunske odzivnosti, so iz kliničnih preskušanj pri urotelijskem karcinomu izključili (glejte poglavji 4.5 in 5.1).
English: The median duration of response is 18.0 months (6.6, NE) for the 22 responders to nivolumab who had failed to achieve response with prior brentuximab vedotin treatment.
Slovenian: Pri 22 bolnikih z odzivom na zdravljenje z nivolumabom, ki niso dosegli odziva pri predhodnem zdravljenju z brentuksimabom vedotinom, mediano trajanje odziva znaša 18,0 meseca (6,6; NE).
English: Upon improvement, nivolumab or nivolumab in combination with ipilimumab may be resumed after corticosteroid taper.
Slovenian: Po izboljšanju in postopnem zmanjšanju odmerka kortikosteroida se zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom lahko nadaljuje.
English: Open-label phase 1/2 study (CA209032)
Slovenian: faze (študija CA209032)
English: ──Δ─── Nivolumab 3 mg/kg (events: 86/135), median and 95% CI: 9.23 (7.33, 13.27) - - -- - - Docetaxel (events: 113/137), median and 95% CI: 6.01 (5.13, 7.33)
Slovenian: - - -- - - docetaksel (dogodki: 113/137), mediana in 95 % IZ: 6,01 (5,13; 7,33)
English: Patients with a baseline performance score ≥ 2, active brain or leptomeningeal metastases, active autoimmune disease, medical conditions requiring systemic immunosuppression, or carcinoma of the nasopharynx or salivary gland as the primary tumour sites were excluded from the SCCHN clinical trial (see sections 4.5 and 5.1).
Slovenian: Bolnike z izhodiščno oceno telesne zmogljivosti ≥ 2, aktivnimi zasevki v možganih ali leptomeningah, aktivno avtoimunsko boleznijo, zdravstvenimi stanji, ki jih je treba zdraviti z zdravili za sistemsko zaviranje imunske odzivnosti ali s karcinomom nosnega dela žrela ali žleze slinavke kot primarnega mesta tumorja, so iz kliničnega preskušanja pri SCCHN izključili (glejte poglavji 4.5 in 5.1).
English: The majority of the patients had AJCC Stage IV disease (93%); 58% had M1c disease at study entry.
Slovenian: Večina bolnikov je imela bolezen v stadiju IV po AJCC (93 %).
English: For symptomatic diabetes, nivolumab or nivolumab in combination with ipilimumab should be withheld, and insulin replacement should be initiated as needed.
Slovenian: V primeru simptomatskega diabetesa je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom zadržati in po potrebi uvesti zdravljenje z insulinom.
English: PD-L1 < 1%, PD-L1+ TAIC abundantd
Slovenian: PD-L1  1 %, PD-L1+ TAIC obilnod (61 nivolumab, 47 izbira raziskovalca)
English: ORR (95% CI) by tumour PD-L1 expression n=210
Slovenian: Delež trajanja ≥ 12 mesecev Delež trajanja ≥ 24 mesecev Delež objektivnega odziva (ORR) (95 % IZ) glede na ekspresijo PD-L1 tumorja n = 210
English: Not known tumour lysis syndromei Hepatobiliary disorders Common hepatitisc hepatitisc
Slovenian: Neznana pogostnost sindrom tumorske lizei Bolezni jeter, žolčnika in žolčevodov Pogosti hepatitisc hepatitisc
English: Figure 9: Kaplan-Meier curves of OS (CA209057)
Slovenian: Kaplan-Meierjevi krivulji celokupnega preživetja (študija CA209057)
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev citrat dihidrat natrijev klorid manitol (E421) pentetska kislina (dietilentriaminopentaocetna kislina) polisorbat 80 natrijev hidroksid (za uravnavo pH) klorovodikova kislina (za uravnavo pH) voda za injekcije
English: In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg//kg, the incidence of hypersensitivity/infusion reactions was 4.0% (22/547); all were Grade 1 or 2 in severity.
Slovenian: Pri bolnikih, ki so se zdravili z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg, je pojavnost preobčutljivostnih/infuzijskih reakcij znašala 4,0 % (22/547).
English: Patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1).
Slovenian: Bolnike z anamnezo zasevkov v možganih ali s trenutnimi zasevki v možganih, z aktivno avtoimunsko boleznijo ali zdravstvenimi stanji, ki so zahtevala zdravljenje z zdravili za sistemsko zaviranje imunske odzivnosti, so iz kliničnih preskušanj uporabe nivolumaba ali nivolumaba v kombinaciji z ipilimumabom izključili (glejte poglavji 4.5 in 5.1).
English: Seventy-four percent of patients had cutaneous melanoma, and 11% had mucosal melanoma; 35% of patients had PD-L1 positive melanoma (≥ 5% tumour cell membrane expression).
Slovenian: 35 % bolnikov je imelo PD-L1 pozitiven melanom (≥ 5 % ekspresija tumorske celične membrane).
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.35 (0.22, 0.55) Nivolumab vs. Ipilimumab - hazard ratio: 0.41 (0.27, 0.62) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.87 (0.54, 1.41)
Slovenian: nivolumab+ipilimumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,35 (0,22; 0,55) nivolumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,41 (0,27; 0,62) nivolumab+ipilimumab v primerjavi z nivolumabom - razmerje ogroženosti: 0,87 (0,54; 1,41)
English: Nivolumab or nivolumab in combination with ipilimumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy.
Slovenian: Dokler bolnik prejema imunosupresivne odmerke kortikosteroidov ali drugih zdravil za zaviranje imunske odzivnosti, se zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom ne sme nadaljevati.
English: Nivolumab or nivolumab in combination with ipilimumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Slovenian: V primeru izpuščaja stopnje 3 je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom zadržati, v primeru izpuščaja stopnje 4 pa zdravljenje ukiniti.
English: (95% CI) Rate (95% CI) at 60 months
Slovenian: (95 % IZ) Delež (95 % IZ) v 24. mesecu
English: For Grade 4 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru zvišanja serumskega kreatinina stopnje 4 je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
English: Grade 4 diarrhoea or colitis
Slovenian: Driska ali kolitis stopnje 4
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced or metastatic non-squamous NSCLC were evaluated in a phase 3, randomised, open-label study (CA209057).
Slovenian: Varnost in učinkovitost nivolumaba v odmerku 3 mg/kg kot samostojnega zdravila za zdravljenje napredovalega ali metastatskega neploščatoceličnega NSCLC so vrednotili v randomizirani, odprti študiji 3. faze (CA209057).
English: Figure 8: Kaplan-Meier curves of OS (CA209017)
Slovenian: Kaplan-Meierjevi krivulji celokupnega preživetja (študija CA209017)
English: from the study.
Slovenian: Primarna analiza
English: Grade 2 diarrhoea or colitis
Slovenian: Driska ali kolitis stopnje 2
English: Additional efficacy measures included duration of response, PFS and OS.
Slovenian: Dodatna merila učinkovitosti vključujejo trajanje odziva, preživetje brez napredovanja bolezni in celokupno preživetje.
English: Severe hepatitis has been observed with nivolumab monotherapy or nivolumab in combination with ipilimumab (see section 4.8).
Slovenian: Pri zdravljenju z nivolumabom v monoterapiji ali zdravljenju z nivolumabom v kombinaciji z ipilimumabom so poročali o hudem hepatitisu (glejte poglavje 4.8).
English: Median (95% CI) (months) Rate (95% CI) at 12 months
Slovenian: Mediana (95 % IZ) (meseci) Delež (95 % IZ) v 12. mesecu
English: Uncommon vasculitis Respiratory, thoracic and mediastinal disorders Common pneumonitisa,c, dyspnoeaa, cough Uncommon pleural effusion Rare lung infiltration
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti pnevmonitisa,c, dispnejaa, kašelj
English: Median (95% CI) months Rate (95% CI) at 12 months
Slovenian: Mediana (95 % IZ) meseci Delež (95 % IZ) v 12. mesecu
English: Caution should be used when considering the use of nivolumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immunestimulatory anticancer agents.
Slovenian: Pri bolnikih z resnimi ali s smrtno nevarnimi kožnimi neželenimi učinki pri predhodnem zdravljenju raka z drugimi zdravili za imunsko stimulacijo je treba možnost uporabe nivolumaba previdno pretehtati.
English: Not known solid organ transplant rejectionh, sarcoidosish Endocrine disorders
Slovenian: Neznana pogostnost zavrnitev presadka čvrstega organah, sarkoidozah Bolezni endokrinega sistema Pogosti hipotiroidizem, hipertiroidizem
English: Progression-free survival Rate (95% CI) at 24 months
Slovenian: Preživetje brez napredovanja bolezni Delež (95 % IZ) v 12. mesecu
English: CA209205 Cohort Cb
Slovenian: Kohorta C študije CA209205b
English: For Grade 3 or 4 pneumonitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru pljučnice stopnje 3 ali 4 je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 2 do 4 mg/kg/dan metilprednizolona.
English: The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced RCC with a clear cell component was evaluated in a Phase 3, randomised, open-label study (CA209025).
Slovenian: Varnost in učinkovitost nivolumaba v odmerku 3 mg/kg kot samostojnega zdravila za zdravljenje napredovalega svetloceličnega karcinoma ledvičnih celic so vrednotili v randomizirani, odprti študiji 3. faze (študija CA209025).
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency.
Slovenian: V primeru hude (stopnja 3) ali življenje ogrožajoče (stopnja 4) insuficience nadledvičnih žlez je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom trajno ukiniti.
English: How to store OPDIVO
Slovenian: Shranjevanje zdravila OPDIVO
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each mL of concentrate contains 10 mg of nivolumab.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En ml koncentrata vsebuje 10 mg nivolumaba.
English: The ORRs in the BRAF mutation-positive subgroup were 17% (95% CI: 8.4, 29.0) for nivolumab and 11% (95% CI: 2.4, 29.2) for chemotherapy, and in the BRAF wild-type subgroup were 30% (95% CI: 24.0, 36.7) and 9% (95% CI: 4.6, 16.7), respectively.
Slovenian: V podskupini bolnikov z divjim tipom BRAF je delež objektivnega odziva pri zdravljenju z nivolumabom znašal 30 % (95 % interval zaupanja: 24,0; 36,7), pri zdravljenju s kemoterapijo pa 9 % (95 % interval zaupanja: 4,6; 16,7).
English: The median age was 60 years (range: 28-83) with 31% ≥ 65 years of age and 5% ≥ 75 years of age, 83% were male, and 83% were white.
Slovenian: Mediana starost bolnikov je bila 60 let (razpon: 28-83), 31 % bolnikov je bilo starih  65 let, 5 % bolnikov pa  75 let.
English: Grade 3 diarrhoea or colitis observed with nivolumab in combination with ipilimumab requires permanent discontinuation of treatment and initiation of corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru driske ali kolitisa stopnje 3 pri zdravljenju z nivolumabom v kombinaciji z ipilimumabom je treba zdravljenje trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
English: The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed PFS and objective response rate (ORR).
Slovenian: Ključni sekundarni merili učinkovitosti sta bili raziskovalčeva ocena preživetja brez napredovanja bolezni in delež objektivnega odziva.
English: The estimated 2 and 3 year OS rates were 68% (95% CI: 56, 78) and 61% (95% CI: 49, 71), respectively, for the combination (n = 73) and 53% (95% CI: 36, 68) and 44% (95% CI: 28, 60), respectively, for ipilimumab (n = 37).
Slovenian: V skupini s kombiniranim zdravljenjem (n = 73) je ocenjeni delež celokupnega preživetja po 2 letih znašal 68 % (95 % interval zaupanja: 56, 78), po 3 letih pa 61 % (95 % interval zaupanja: 49, 71).
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for life-threatening (Grade 4) hypophysitis.
Slovenian: V primeru življenje ogrožajočega (stopnja 4) vnetja hipofize je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom trajno ukiniti.
English: Nivolumab in combination with ipilimumab should be discontinued for life-threatening or recurrent severe cardiac and pulmonary adverse reactions (see section 4.2).
Slovenian: V primeru pojava življenje ogrožajočih ali ponovitve hudih neželenih učinkov za srce in pljuča je treba zdravljenje z nivolumabom v kombinaciji z ipilimumabom ukiniti (glejte poglavje 4.2).
English: Docetaxel ──Δ─── Nivolumab 3 mg/kg (events: 190/292), median and 95% CI: 12.19 (9.66, 14.98) - - -- - - Docetaxel (events: 223/290), median and 95% CI: 9.36 (8.05, 10.68) The trial demonstrated a statistically significant improvement in OS for patients randomised to nivolumab as compared with docetaxel at the prespecified interim analysis when 413 events were observed (93% of the planned number of events for final analysis).
Slovenian: ──Δ─── nivolumab 3 mg/kg (dogodki: 190/292), mediana in 95 % IZ: 12,19 (9,66; 14,98) - - -- - - docetaksel (dogodki: 223/290), mediana in 95 % IZ: 9,36 (8,05; 10,68)
English: The study included adult patients with confirmed unresectable Stage III or Stage IV melanoma.
Slovenian: V študijo so bili vključeni odrasli bolniki s potrjenim neoperabilnim melanomom v stadiju III ali stadiju IV. Bolniki so morali imeti oceno stanja telesne zmogljivosti po lestvici ECOG 0 ali 1.
English: Withhold dose(s)
Slovenian: Aplikacijo odmerka (odmerkov) zadržite.
English: For Grade 4 diarrhoea or colitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru driske ali kolitisa stopnje 4 je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
English: In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg, the incidence of hypersensitivity/infusion reactions was 3.8% (17/448); all were Grade 1 or 2 in severity.
Slovenian: Pri bolnikih, ki so se zdravili z nivolumabom v odmerku 1 mg/kg v kombinaciji z ipilimumabom v odmerku 3 mg/kg, je pojavnost preobčutljivostnih/infuzijskih reakcij znašala 3,8 % (17/448).
English: Severe nephritis and renal dysfunction have been observed with monotherapy treatment or nivolumab in combination with ipilimumab (see section 4.8).
Slovenian: Imunsko pogojeni nefritis in okvara delovanja ledvic Pri zdravljenju z nivolumabom v monoterapiji ali zdravljenju z nivolumabom v kombinaciji z ipilimumabom so poročali o hudem nefritisu in okvari delovanja ledvic (glejte poglavje 4.8).
English: Nivolumab monotherapy should be withheld for Grade 3 diarrhoea or colitis, and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru driske ali kolitisa stopnje 3 je treba zdravljenje z nivolumabom v monoterapiji zadržati in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
English: Uncommon adrenal insufficiency, hypopituitarism, hypophysitis, thyroiditis, diabetes mellitus Rare diabetic ketoacidosis
Slovenian: Občasni insuficienca nadledvičnih žlez, hipopituitarizem, vnetje hipofize, vnetje ščitnice, diabetes
English: Odds Ratio (95% CI)
Slovenian: Razmerje obetov (95 % IZ)
English: For Grade 3 or 4 transaminase or total bilirubin elevation, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru zvišanja vrednosti aminotransferaz ali skupnega bilirubina stopnje 3 ali 4 je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
English: Uncommon dehydration, metabolic acidosis Not known tumour lysis syndromei Hepatobiliary disorders Uncommon hepatitisc Rare cholestasis
Slovenian: Neznana pogostnost sindrom tumorske lizei Bolezni jeter, žolčnika in žolčevodov Občasni hepatitisc
English: Median (95% CI) months Rate (95% CI) at 6 months Overall survivalc
Slovenian: Mediana (95 % IZ) v mesecih Delež (95 % IZ) v 6. mesecu
English: Nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued for any severe immune-related adverse reaction that recurs and for any life-threatening immune-related adverse reaction.
Slovenian: Če se kateri koli resni imunsko pogojeni neželeni učinek ponovi, ali pojavi kateri koli resni imunsko pogojeni neželeni učinek, ki ogrozi življenje, je treba zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom trajno ukiniti.
English: Table 14: Efficacy results (CA209017)
Slovenian: Preglednica 14: Rezultati učinkovitosti (študija CA209017) nivolumab (n = 135)
English: CA209205 Cohort Ca
Slovenian: Kohorta C študije CA209205a
English: ECOG PS 2 CNS Metastasis
Slovenian: Samsung Biologics Co. Ltd.
English: Immune-related adverse reactions have occurred at higher frequencies when nivolumab was administered in combination with ipilimumab compared with nivolumab as monotherapy.
Slovenian: Pri uporabi nivolumaba v kombinaciji z ipilimumabom je bila pojavnost imunsko pogojenih neželenih učinkov večja kot pri uporabi nivolumaba v monoterapiji.
English: 8.7,22.2%), a median OS of 8.21 months (95% CI: 6.05,10.9), and a median PFS of 1.87 months (95% CI 1.77,3.15).
Slovenian: Pri uporabi nivolumaba v odmerku 3 mg/kg je delež ORR znašal 14,5 % (95 % interval zaupanja: 8,7; 22,2 %), mediana celokupnega preživetja 8,21 meseca (95 % interval zaupanja: 6,05; 10,9 meseca), mediana preživetja brez napredovanja bolezni pa 1,87 meseca (95 % interval zaupanja: 1,77; 3,15 meseca).
English: Fluid in the lungs
Slovenian: Redki pljučni infiltrati
English: Uncommon uveitis
Slovenian: Občasni vaskulitis
English: The following side effects have been reported with nivolumab alone:
Slovenian: Pri uporabi nivolumaba kot edinim zdravilom so poročali o naslednjih neželenih učinkih:
English: Severe rash has been observed with nivolumab in combination with ipilimumab and, less commonly, with nivolumab as monotherapy (see section 4.8).
Slovenian: Pri zdravljenju z nivolumabom v kombinaciji z ipilimumabom, redkeje pa tudi pri zdravljenju z nivolumabom v monoterapiji, so poročali o hudem izpuščaju, ki bi lahko bil imunsko pogojen (glejte poglavje 4.8).
English: A total of 270 patients who received nivolumab 3 mg/kg administered intravenously over 60 minutes every 2 weeks with a minimum follow-up of 8.3 months were evaluable for efficacy.
Slovenian: Učinkovitost so ovrednotili pri skupno 270 bolnikih, ki so prejemali nivolumab v odmerku 3 mg/kg v obliki 60-minutne intravenske infuzije vsaka 2 tedna.
English: Upon improvement, nivolumab or nivolumab in combination with ipilimumab may be resumed after corticosteroid taper, if needed.
Slovenian: Po izboljšanju in postopnem zmanjšanju odmerka kortikosteroida, če je bilo takšno zdravljenje potrebno, se zdravljenje z nivolumabom ali nivolumabom v kombinaciji z ipilimumabom lahko nadaljuje.
English: Ipilimumab
Slovenian: Izdelovalec
English: In-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Slovenian: OPDIVO raztopina za infundiranje je kompatibilna: z vsebniki iz PVC-ja, z vsebniki iz poliolefina, s steklenicami, z infuzijskimi sistemi iz PVC-ja, z linijskimi filtri z membranami iz polietersulfona z velikostjo por od 0,2 µm do 1,2 µm.