FrancophonIA/ELRC3.0 huggingface dataset:
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and ipilimumab in combination with nivolumab must be permanently discontinued.
Slovenian: Če se stanje kljub uvedbi zdravljenja s kortikosteroidi poslabša ali ne izboljša, je treba odmerek kortikosteroida povečati do odmerka, ki ustreza 2 do 4 mg/kg/dan metilprednizolona, zdravljenje z ipilimumabom v kombinaciji z nivolumabom pa trajno ukiniti.
English: Ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg
Slovenian: Ipilimumab v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg
English: Uncommon arrhythmia, atrial fibrillation Vascular disorders
Slovenian: Srčne bolezni Občasni aritmija, atrijska fibrilacija
English: In patients who received ipilimumab 3 mg/kg monotherapy in a Phase 3 study of advanced (unresectable or metastatic) melanoma (MDX010-20, see section 5.1), the median time to onset of severe or fatal (Grade 3-5) immune-related gastrointestinal reactions was 8 weeks (range 5 to 13 weeks) from the start of treatment.
Slovenian: Pri bolnikih, ki so v klinični študiji 3. faze pri napredovalem (neoperabilnem ali metastatskem) melanomu (MDX010-20, glejte poglavje 5.1) prejemali ipilimumab v odmerku 3 mg/kg kot monoterapijo, je bil mediani čas do pojava hudih ali usodnih (stopnje 3 do 5) imunsko pogojenih neželenih učinkov v prebavilih 8 tednov (razpon od 5 do 13 tednov) od začetka zdravljenja.
English: You must use effective contraception while you are being treated with YERVOY if you are a woman who could become pregnant.
Slovenian: Če ste v rodni dobi, morate med zdravljenjem z zdravilom YERVOY uporabljati učinkovito obliko kontracepcije.
English: Median time to onset was 2.6 months (range: 0.25-20.6).
Slovenian: Mediani čas do nastopa je znašal 2,6 meseca (razpon: 0,25-20,6).
English: The OS HRs for ipilimumab in combination with nivolumab vs. nivolumab monotherapy were 0.71 (95% CI: 0.45, 1.13) for BRAF[V600] mutation-positive patients and 0.97 (95% CI: 0.74, 1.28) for BRAF wild-type patients.
Slovenian: Pri bolnikih, pozitivnih na mutacijo BRAF[V600], je HR za celokupno preživetje pri ipilimumabu v kombinaciji z nivolumabom v primerjavi z nivolumabom v monoterapiji znašalo 0,71 (95 % interval zaupanja: 0,45; 1,13), pri bolnikih z divjim tipom BRAF pa 0,97 (95 % interval zaupanja: 0,74; 1,28).
English: Median time to onset was 2.6 months (range: 0.5-21.8).
Slovenian: Mediani čas do pojava je znašal 2,6 meseca (razpon: 0,5-21,8).
English: No new adverse drug reactions were reported in adolescents 12 years of age and older.
Slovenian: Pri mladostnikih, starih 12 let in starejših, niso poročali o novih neželenih učinkih zdravila.
English: Caution should be taken when ipilimumab is given following or in combination with a PD-1 or PD-L1 inhibitor.
Slovenian: Pri uporabi ipilimumaba po zdravljenju z zaviralcem PD-1 ali PD-L1 ali v primeru sočasnega zdravljenja je potrebna previdnost.
English: Tris hydrochloride (2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride) Sodium chloride
Slovenian: 6.1 Seznam pomožnih snovi tris v obliki klorida (2-amino-2-hidroksimetil-1,3-propandiolijev klorid) natrijev klorid manitol (E421) pentetska kislina (dietilentriaminopentaocetna kislina) polisorbat 80 natrijev hidroksid (za uravnavo pH) klorovodikova kislina (za uravnavo pH) voda za injekcije
English: PD-L1 expression ≥ 1%
Slovenian: Ekspresija PD-L1 ≥ 1%
English: However, once you are treated with YERVOY, your doctor may give you corticosteroids to reduce the side-effects that you may have with YERVOY.
Slovenian: Po začetku zdravljenja z zdravilom YERVOY pa vam zdravnik za zdravljenje neželenih učinkov zdravila YERVOY lahko predpiše uporabo kortikosteroidov.
English: Median OS (95% CI)
Slovenian: Mediana OS (95% IZ)
English: Based on the severity of the adverse reaction, ipilimumab, or ipilimumab in combination with nivolumab should be withheld and corticosteroids administered.
Slovenian: Na osnovi resnosti neželenega učinka je treba zdravljenje z ipilimumabom ali z ipilimumabom v kombinaciji z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi.
English: Immune-related colitis Ipilimumab in combination with nivolumab
Slovenian: Imunsko pogojeni kolitis Ipilimumab v kombinaciji z nivolumabom
English: Laboratory abnormalities with ipilimumab in combination with nivolumab
Slovenian: Laboratorijsko ugotovljene nepravilnosti pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom
English: Respiratory, thoracic and mediastinal disorders Very common dyspnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti dispneja
English: Each ml of concentrate contains 5 mg of ipilimumab.
Slovenian: En mililiter koncentrata vsebuje 5 mg ipilimumaba.
English: In the ipilimumab 3 mg/kg monotherapy group, hypopituitarism of any severity was reported in 4% of patients.
Slovenian: V skupini, ki je ipilimumab prejemala v odmerku 3 mg/kg kot monoterapijo, so pri 4 % bolnikov poročali o pojavu hipopituitarizma vseh jakosti.
English: triad of symptoms (meningism): neck stiffness, intolerance of bright light and headache, flu-like discomfort inflammation of the heart muscle, weakness of the heart muscle, fluid around the heart inflammation of the liver or the pancreas, nodules of inflammatory cells in various organs of your body infection within the abdomen painful skin lesions of the arms and legs and face (erythema nodosum) overactive pituitary gland decreased function of the parathyroid gland inflammation of the eye, eye muscle inflammation decreased hearing poor blood circulation which makes toes and fingers numb or pale damage to the tissues of the hands and feet resulting in redness, swelling and blisters
Slovenian: skupek treh simptomov (meningizem): togost vratu, občutljivost za močno svetlobo in glavobol, neugodje, podobno kot pri gripi vnetje srčne mišice, oslabelost srčne mišice, nabiranje tekočine okrog srca vnetje jeter ali trebušne slinavke, vozliči vnetnih celic v različnih organih telesa okužba v trebušni votlini boleče spremembe na koži rok, nog in obraza (nodozni eritem) čezmerno delovanje hipofize zmanjšano delovanje obščitnic vnetje oči, vnetje očesnih mišic oslabljen sluh slaba prekrvavitev, ki povzroči odrevenelost ali bledico prstov nog ali rok okvara tkiva na dlaneh in podplatih, ki ima za posledico rdečino, otekanje in pojav mehurjev
English: The following side effects have been reported in patients receiving 3 mg/kg ipilimumab alone:
Slovenian: Pri bolnikih, ki so prejemali 3 mg/kg ipilimumaba samostojno so poročali o pojavu naslednjih neželenih učinkov:
English: Abnormal liver function tests (increased amounts of the liver enzymes aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase in your blood, higher blood levels of the waste product bilirubin)
Slovenian: Preiskave Pogosti zvišanje vrednosti alanin-aminotransferazec, zvišanje vrednosti aspartataminotransferazec, zvišanje vrednosti alkalne fosfataze v krvid, zvišanje vrednosti bilirubina v krvi, zmanjšanje telesne mase
English: BORR was similar in the 10 mg/kg and 3 mg/kg groups.
Slovenian: Najboljši celokupni delež odziva (BORR-best overall response rate) je bil v skupini z odmerkom 10 mg/kg in odmerkom 3 mg/kg podoben.
English: Nivolumab+Ipilimumab (events: 29/68), median and 95% CI: N.A. (9.72, N.A.) ──Δ─── Nivolumab (events: 38/80), median and 95% CI: 21.95 (8.90, N.A.) Ipilimumab (events: 57/75), median and 95% CI: 3.94 (2.79, 4.21)
Slovenian: Število ogroženih oseb nivolumab + ipilimumab nivolumab ipilimumab nivolumab+ipilimumab (dogodki: 29/68), mediana in 95% IZ: NP (9,72; NP) ──Δ─── nivolumab (dogodki: 38/80), mediana in 95 % IZ: 21,95 (8,90; NP) ipilimumab (dogodki: 57/75), mediana in 95 % IZ: 3,94 (2,79; 4,21)
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of diarrhoea or colitis was 46.7% (209/448).
Slovenian: Pri bolnikih z melanomom, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg, je pojavnost driske ali kolitisa znašala 46,7 % (209/448).
English: Adverse events leading to discontinuation in the 10 mg/kg and 3 mg/kg groups occurred in 31% and 19% of patients, with AEs leading to death in 4 and 2 patients, respectively.
Slovenian: Zaradi neželenih učinkov je bilo treba zdravljenje v skupini z odmerkom 10 mg/kg prekiniti pri 31 % bolnikov, v skupini z odmerkom 3 mg/kg pa pri 19 % bolnikov.V skupini z odmerkom 10 mg/kg so o neželenih učinkih s smrtnim izidom poročali pri 4 bolnikih, v skupini z odmerkom 3 mg/kg pa pri 2 bolnikih.
English: Uncommon sepsisb, septic shockb, urinary tract infection, respiratory tract infection Neoplasms benign, malignant and unspecified (including cysts and polyps) Common tumour pain
Slovenian: Občasni sepsab, septični šokb, okužba sečil, okužba dihal Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Pogosti bolečina zaradi raka
English: Clinical trials with ipilimumab monotherapy
Slovenian: Klinična preskušanja z ipilimumabom v monoterapiji
English: For Grade 2 (symptomatic) pneumonitis, ipilimumab in combination with nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru pljučnice stopnje 2 (simptomatska) je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 mg/kg/dan metilprednizolona.
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of pneumonitis including interstitial lung disease, was 7.8% (35/448).
Slovenian: Pri bolnikih z melanomom, ki so se zdravili z ipilumabom v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg, je pojavnost pnevmonitisa, vključno z boleznijo pljučnega intersticija, znašala 7,8 % (35/448).
English: For Grade 2 or 3 serum creatinine elevation, ipilimumab in combination with nivolumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Slovenian: V primeru zvišanja serumskega kreatinina stopnje 2 ali 3 je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 0,5 do 1 mg/kg/dan metilprednizolona.
English: Nivolumab+Ipilimumab (events: 111/210), median and 95% CI: 11.10 (7.98, 22.18) ──Δ─── Nivolumab (events: 125/208), median and 95% CI: 5.32 (2.83, 7.06) Ipilimumab (events: 159/202), median and 95% CI: 2.83 (2.76, 3.09)
Slovenian: Število ogroženih oseb nivolumab + ipilimumab nivolumab ipilimumab nivolumab+ipilimumab (dogodki: 111/210), mediana in 95% IZ: 11,10 (7,98; 22,18) ──Δ─── nivolumab (dogodki: 125/208), mediana in 95 % IZ: 5,32 (2,83; 7,06) ipilimumab (dogodki: 159/202), mediana in 95 % IZ: 2,83 (2,76; 3,09)
English: Efficacy by BRAF status: After18 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to ipilimumab in combination with nivolumab had a median PFS of 15.5 months (95% CI: 8.0, NA) and 11.3 months (95% CI: 8.3, 22.2), while those in the nivolumab monotherapy arm had a median PFS of 5.6 months (95% CI: 2.8, 9.3) and 7.1 months (95% CI: 4.9, 14.3), respectively.
Slovenian: Učinkovitost glede na status BRAF: Po 18 mesecih spremljanja je pri bolnikih, pozitivnih na mutacijo BRAF[V600], ki so bili randomizirani na zdravljenje z ipilimumabom v kombinaciji z nivolumabom, mediana preživetja brez napredovanja bolezni znašala 15,5 meseca (95 % interval zaupanja: 8,0; NP), pri bolnikih z divjim tipom BRAF pa 11,3 meseca (95 % interval zaupanja: 8,3; 22,2).
English: PD-L1 expression < 1%
Slovenian: Ekspresija PD-L1 < 1%
English: Grade 3 or 4 diarrhoea or colitis
Slovenian: driska ali kolitis stopnje 3 ali 4
English: The recommended dose is 1 mg/kg ipilimumab in combination with 3 mg/kg nivolumab administered intravenously every 3 weeks for the first 4 doses.
Slovenian: Priporočeni odmerek pri prvih 4 odmerkih je 1 mg/kg ipilimumaba v kombinaciji s 3 mg/kg nivolumaba, ki ju bolnik prejme intravensko vsake 3 tedne.
English: If you become pregnant while using YERVOY tell your doctor.
Slovenian: Če med zdravljenjem z zdravilom YERVOY zanosite, o tem obvestite zdravnika.
English: Time to onset of moderate to severe or fatal (Grade 2 to 5) immune-related hepatotoxicity ranged from 3 to 9 weeks from the start of treatment.
Slovenian: Zmerni do hudi ali usodni (stopnje 2 do 5) imunsko pogojeni toksični učinki za jetra so se pojavili od 3 do 9 tednov po začetku zdravljenja.
English: It contains 2.3 mg sodium per ml of concentrate.
Slovenian: En mililiter koncentrata vsebuje 2,3 mg natrija.
English: Cytomegalovirus (CMV) infection/reactivation evaluated with viral PCR on biopsy, and other viral, bacterial and parasitic etiology).
Slovenian: Pri imunsko pogojenem kolitisu, odpornem na zdravljenje s kortikosteroidi, je treba razmisliti o dodatnem zdravljenju z drugim imunosupresivom, poleg zdravljenja s kortikosteroidi, če so izključeni drugi vzroki (vključno z okužbo/reaktivacijo okužbe s citomegalovirusom, ocenjenega z virusnim testom PCR po biopsiji, in drugo virusno, bakterijsko in parazitno etiologijo).
English: OS of ipilimumab 3 mg/kg monotherapy in chemotherapy-naive patients pooled across Phase 2 and 3 clinical trials (N= 78; randomised) and in treatment-naive patients in two retrospective observational studies (N= 273 and N= 157) were generally consistent.
Slovenian: Pri bolnikih, ki se še niso zdravili s kemoterapijo (združeni podatki iz kliničnih preskušanj 2. in 3. faze [N= 78; randomizirani]), in pri predhodno nezdravljenih bolnikih (podatki iz dveh retrospektivnih opazovalnih študij [N= 273 in N= 157]) je bilo celokupno preživetje pri zdravljenju z ipilimumabom v odmerku 3 mg/kg v obliki monoterapije na splošno konsistentno.
English: One 40 ml vial contains 200 mg of ipilimumab.
Slovenian: Ena 40 ml viala vsebuje 200 mg ipilimumaba.
English: Ipilimumab has been administered to approximately 10,000 patients in a clinical program evaluating its use with various doses and tumour types.
Slovenian: V kliničnem programu, s katerim so vrednotili uporabo različnih odmerkov ipilimumaba pri različnih tipih tumorjev, je ipilimumab prejelo približno 10.000 bolnikov.
English: Nivolumab Ipilimumab
Slovenian: Občasni plevralni izliv
English: After 28 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to ipilimumab in combination with nivolumab had an ORR of 67.6% (95% CI: 57.7, 76.6; n = 102) and 54.7% (95% CI: 47.8, 61.5; n = 212), while those in the nivolumab monotherapy arm had an ORR of 36.7% (95% CI: 27.2, 47.1; n = 98) and 48.2% (95% CI: 41.4, 55.0; n = 218), respectively.
Slovenian: Po 28 mesecih spremljanja je pri bolnikih, pozitivnih na mutacijo BRAF[V600], ki so bili randomizirani na zdravljenje z ipilimumabom v kombinaciji z nivolumabom, je delež celokupnega odziva znašal 67,6 % (95 % interval zaupanja: 57,7; 76,6; n = 102), pri bolnikih z divjim tipom BRAF pa 54,7 % (95 % interval zaupanja: 47,8; 61,5; n = 212).
English: At the time of this analysis, the hazard ratio was 0.66; (99.8% CI 0.48-0.91) with 166/425 events in the combination arm and 209/422 events in the sunitinib arm. At 18 months, the OS rate was 74.3 (95% CI 69.8-78.2) for ipilimumab in combination with nivolumab and 59.9 (95% CI 54.9-64.5) for sunitinib.
Slovenian: V času te analize je razmerje ogroženosti znašalo 0,66 (99,8 % IZ 0,48-0,91) s 166/425 dogodkov v skupini kombiniranega zdravljenja in z 209/422 dogodkov v skupini zdravljenja s sunitinibom.
English: Ipilimumab must be permanently discontinued in patients with a very severe (Grade 4) rash or severe (Grade 3) pruritus (see section 4.2), and systemic high-dose intravenous corticosteroid therapy (e.g. methylprednisolone 2 mg/kg/day) should be initiated immediately.
Slovenian: Pri bolnikih z zelo hudim (stopnja 4) izpuščajem ali hudim (stopnja 3) srbenjem je treba zdravljenje z ipilimumabom ukiniti (glejte poglavje 4.2) in nemudoma uvesti sistemsko zdravljenje z visokimi odmerki intravenskih kortikosteroidov (npr. metilprednizolon v odmerku 2 mg/kg/dan).
English: PD-L1 expression < 5%
Slovenian: Ekspresija PD-L1 < 5%
English: The recommended dose is 3 mg/kg ipilimumab in combination with 1 mg/kg nivolumab administered intravenously every 3 weeks for the first 4 doses.
Slovenian: Priporočeni odmerek pri prvih 4 odmerkih je 3 mg/kg ipilimumaba v kombinaciji z 1 mg/kg nivolumaba, ki ju bolnik prejme intravensko vsake 3 tedne.
English: In the ipilimumab 3 mg/kg monotherapy group, median OS was 22 months and 8 months for patients with SD and those with PD, respectively.
Slovenian: V skupini, ki je prejemala ipilimumab v odmerku 3 mg/kg kot monoterapijo, je mediano celokupno preživetje pri bolnikih s stabilno boleznijo znašalo 22 mesecev, pri bolnikih s progresijo bolezni pa 8 mesecev.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of diarrhoea or colitis was 28.2% (154/547).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z ipilimumabom v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg, je pojavnost driske ali kolitisa znašala 28,2 % (154/547).
English: If applicable, dilute with the required volume of sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection.
Slovenian: Če je primerno, koncentrat razredčite s potrebno količino 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje ali 50 mg/ml (5 %) raztopine glukoze za injiciranje.
English: If resolution occurs, resume therapy.d
Slovenian: Če se stanje izboljša, nadaljujte z zdravljenjem.d
English: Patients ≥ 75 years of age represented 8% of all intermediate/poor risk patients in CA209214, and the combination of ipilimumab with nivolumab showed numerically less effect on OS (HR 0.97, 95% CI: 0.48, 1.95) in this subgroup versus the overall population.
Slovenian: V tej podskupini bolnikov je kombinacija ipilimumaba z nivolumabom imela numerično manjši učinek na celokupno preživetje (HR 0,97; 95 % IZ: 0,48; 1,95) v primerjavi s celotno populacijo.
English: Nivolumab+Ipilimumab (events: 63/123), median and 95% CI: 11.24 (6.93, 23.03) ──Δ─── Nivolumab (events: 77/117), median and 95% CI: 2.83 (2.76, 5.13) Ipilimumab (events: 87/113), median and 95% CI: 2.79 (2.66, 2.96)
Slovenian: Število ogroženih oseb nivolumab + ipilimumab nivolumab ipilimumab nivolumab+ipilimumab (dogodki: 63/123), mediana in 95 % IZ: 11,24 (6,93; 23,03) ──Δ─── nivolumab (dogodki: 77/117), mediana in 95 % IZ: 2,83 (2,76; 5,13) ipilimumab (dogodki: 87/113), mediana in 95 % IZ: 2,79 (2,66; 2,96)
English: Very common (may affect more than 1 in 10 people) underactive thyroid gland (which can cause tiredness or weight gain), overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss) loss of appetite headache shortness of breath (dyspnoea) inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools), vomiting or feeling sick (nausea), stomach pain skin rash sometimes with blisters, itching pain in the muscles and bones (musculoskeletal pain), painful joints (arthralgia) feeling tired or weak, fever
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov) zmanjšano delovanje ščitnice (kar lahko povzroči utrujenost ali povečanje telesne mase), prekomerno delovanje ščitnice (kar lahko povzroči hitro utripanje srca, znojenje in zmanjšanje telesne mase) izguba apetita glavobol oteženo dihanje (dispneja) vnetje črevesa (kolitis), driska (vodeno, kašasto ali mehko blato), bruhanje, siljenje na bruhanje, bolečina v trebuhu kožni izpuščaj, včasih z mehurčki, srbenje bolečina v mišicah in kosteh (mišično-skeletna bolečina), bolečina v sklepih (artralgija) občutek utrujenosti ali šibkosti, zvišana telesna temperatura
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of rash was 48.8% (267/547).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z ipilimumabom v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg, je pojavnost izpuščaja znašala 48,8 % (267/547).
English: One 10 ml vial contains 50 mg of ipilimumab.
Slovenian: Ena 10 ml viala vsebuje 50 mg ipilimumaba.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of thyroid disorders was 27.2% (149/547).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z ipilimumabom v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg, je pojavnost bolezni ščitnice znašala 27,2 % (149/547).
English: Median Months (95% CI)
Slovenian: mediana vrednost meseci (95 % IZ)
English: ORRs were higher for the combination of nivolumab and ipilimumab relative to nivolumab monotherapy across tumour PD-L1 expression levels (Table 11) after 28 months of follow-up, with a best overall response of complete response correlating to an improved survival rate.
Slovenian: Po 28 mesecih spremljanja so bili deleži celokupnega odziva večji pri kombinaciji nivolumaba in ipilimumaba v primerjavi z monoterapijo z nivolumabom pri vseh nivojih ekspresije PD-L1 tumorja (preglednica 11).
English: Other studies with ipilimumab monotherapy
Slovenian: Druge študije z ipilimumabom v monoterapiji Melanom
English: Ipilimumab can cause inflammation of the endocrine system organs, manifesting as hypophysitis, hypopituitarism, adrenal insufficiency, and hypothyroidism (see section 4.8), and patients may present with nonspecific symptoms, which may resemble other causes such as brain metastasis or underlying disease.
Slovenian: Ipilimumab lahko povzroči vnetje organov endokrinega sistema, ki se kažejo kot hipofizitis, hipopituitarizem, insuficienca nadledvične žleze in hipotiroidizem (glejte poglavje 4.8).
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of rash was 65.0% (291/448).
Slovenian: Pri bolnikih z melanomom, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg, je pojavnost izpuščaja znašala 65,0 % (291/448).
English: In patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, time to onset of moderate to severe or fatal (Grade 2-5) immune-related hepatotoxicity ranged from 3 to 9 weeks from the start of treatment.
Slovenian: Pri bolnikih, ki so v študiji MDX010-20 prejemali ipilimumab v odmerku 3 mg/kg kot monoterapijo, so se zmerni do hudi ali smrtni (stopnje 2 do 5) imunsko pogojeni hepatotoksični učinki pojavili od 3 do 9 tednov po začetku zdravljenja.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 6.7% (30/448), 15.4% (69/448), and 1.8% (8/448) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 6,7% (30/448) bolnikov, o primerih stopnje 3 pri 15,4% (69/448) bolnikov, o primerih stopnje 4 pa pri 1,8% (8/448) bolnikov.
English: Dosing delay or discontinuation may be required based on individual safety and tolerability.
Slovenian: Na osnovi varnosti in prenašanja zdravila pri posameznem bolniku bo morda potrebno odmerek aplicirati z zamikom ali zdravljenje ukiniti.
English: Do not use if unusual amount of particles and signs of discoloration are present.
Slovenian: Če opazite neobičajno količino delcev ali kakršnokoli drugačno obarvanje, koncentrata ne smete uporabiti.
English: Nivolumab+Ipilimumab (events: 77/155), median and 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (events: 86/171), median and 95% CI: 14.00 (7.03, N.A.) Ipilimumab (events: 129/164), median and 95% CI: 3.91 (2.83, 4.17)
Slovenian: Število ogroženih oseb nivolumab + ipilimumab nivolumab ipilimumab nivolumab+ipilimumab (dogodki: 77/155), mediana in 95 % IZ: 12,35 (8,74; NP) ──Δ─── nivolumab (dogodki: 86/171), mediana in 95 % IZ: 14,00 (7,03; NP) ipilimumab (dogodki: 129/164), mediana in 95 % IZ: 3,91 (2,83; 4.17)