FrancophonIA/ELRC3.0 huggingface dataset:
English: If not used immediately, the infusion solution (undiluted or diluted) may be stored for up to 24 hours in a refrigerator (2°C to 8°C) or at room temperature (20°C to 25°C).
Slovenian: Raztopino za infundiranje (nerazredčeno ali razredčeno), ki ne bo uporabljena takoj, se lahko do 24 ur shranjuje v hladilniku (2 °C do 8 °C) ali pri sobni temperaturi (20 °C do 25 °C).
English: Immune-related neurological reactions
Slovenian: Imunsko pogojeni nevrološki učinki
English: Once symptoms have resolved and LFTs show sustained improvement or return to baseline, the initiation of corticosteroid taper should be based on clinical judgment.
Slovenian: Ko simptomi minejo in se vrednosti jetrnih testov izboljšajo ali vrnejo na izhodiščne vrednosti, je treba na osnovi klinične presoje začeti s postopnim zmanjševanjem odmerka kortikosteroida.
English: Ipilimumab is associated with serious immune-related hepatotoxicity.
Slovenian: Uporaba ipilimumaba je bila povezana s pojavom resnih imunsko pogojenih hepatotoksičnih učinkov.
English: Advanced Melanoma
Slovenian: Napredovali melanom Napredovali melanom
English: For symptomatic Grade 2 or 3 hypophysitis, ipilimumab in combination with nivolumab should be withheld, and hormone replacement should be initiated as needed.
Slovenian: V primeru simptomatskega vnetja hipofize stopnje 2 ali 3 je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati in po potrebi uvesti zdravljenje z nadomeščanjem hormonov.
English: Fatalities due to gastrointestinal perforation have been reported in < 1% of patients who received ipilimumab 3 mg/kg in combination with gp100.
Slovenian: O smrtnih izidih zaradi perforacije v prebavilih so poročali pri manj kot 1 % bolnikov, ki so ipilimumab v odmerku 3 mg/kg prejemali v kombinaciji z gp100.
English: For patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, time to onset of moderate to very severe (Grade 2-4) immune-related endocrinopathy ranged from 7 to nearly 20 weeks from the start of treatment.
Slovenian: Pri bolnikih, ki so v študiji MDX010-20 ipilimumab prejemali v odmerku 3 mg/kg kot monoterapijo, so se zmerne do zelo hude (stopnje 2 do 4) imunsko pogojene endokrinopatije pojavile od 7 pa do skoraj 20 tednov po začetku zdravljenja.
English: A total of 1096 patients were randomised in the trial, of which 847 patients had intermediate/poor-risk RCC and received either ipilimumab 1 mg/kg (n = 425) administered intravenously over 30 minutes in combination with nivolumab administered intravenously over 60 minutes every 3 weeks for 4 doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks or sunitinib (n = 422) 50 mg daily, administered orally for 4 weeks followed by 2 weeks off, every cycle.
Slovenian: Bolniki so prejemali ipilimumab v odmerku 1 mg/kg (n = 425) v obliki 30-minutne intravenske infuzije v kombinaciji z nivolumabom v obliki 60-minutne intravenske infuzije vsake 3 tedne, 4 odmerke; temu je sledilo zdravljenje z nivolumabom v monoterapiji v odmerku 3 mg/kg vsaka 2 tedna, ali sunitinib (n = 422) v odmerku 50 mg na dan peroralno 4 tedne, ki mu je sledilo 2 tedna brez jemanja zdravila pri vsakem ciklu.
English: The frequencies of serious adverse reactions in the 10 mg/kg and 3 mg/kg groups were 37% and 18%, with the 3 most common serious adverse reactions being diarrhea (10.7% vs 5.5%), colitis (8.0% vs 3.0%), and hypophysitis (4.4% vs 1.9%).
Slovenian: Najpogostejši 3 resni neželeni učinki so bili driska (10,7 % v primerjavi s 5,5 %), kolitis (8,0 % v primerjavi s 3,0 %) in vnetje hipofize (4,4 % v primerjavi z 1,9 %).
English: When YERVOY is given in combination with nivolumab for the treatment of advanced kidney cancer, the recommended dose of YERVOY is 1 mg of ipilimumab per kilogram of your body weight every 3 weeks for the first 4 doses (combination phase).
Slovenian: Pri zdravljenju napredovalega raka ledvic z zdravilom YERVOY v kombinaciji z nivolumabom je priporočeni odmerek zdravila YERVOY 1 mg ipilimumaba na kilogram telesne mase vsake 3 tedne za prve 4 odmerke (faza kombiniranega zdravljenja).
English: All patients were HLA-A2*0201 type; this HLA type supports the immune presentation of gp100.
Slovenian: Vsi bolniki so imeli tip HLA-A2*0201.
English: Cardiac and pulmonary adverse events including pulmonary embolism have also been reported with combination therapy.
Slovenian: Pri kombiniranem zdravljenju so poročali o neželenih učinkih za srce in pljuča, vključno s pljučno embolijo.
English: Rare autoimmune thyroiditisd, thyroiditisd Metabolism and nutrition disorders Very common decreased appetite Common dehydration, hypokalemia
Slovenian: Redki avtoimunsko vnetje ščitniced, vnetje ščitniced Presnovne in prehranske motnje Zelo pogosti zmanjšanje apetita
English: Among the patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Slovenian: Pri bolnikih, ki so se v študiji CA209214 zdravili z ipilimumabom v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg, so se pri 169/547 bolnikov (31%) neželeni učinki stopnje 3 ali 4 prvič pojavili med uvodno fazo s kombiniranim zdravljenjem.
English: The safety and efficacy of YERVOY have not been studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter varnosti in učinkovitosti zdravila YERVOY niso raziskovali.
English: ≥ Grade 2 for immune-related eye disorders NOT responding to topical immunosuppressive therapy a
Slovenian: imunsko pogojene reakcije stopnje 3 ali višjec imunsko pogojene bolezni oči stopnje 2 ali višje, ki se NE odzivajo na topikalno zdravljenje z imunosupresivi a
English: These additional reactions occurred at a frequency of < 1% unless otherwise noted: meningism, myocarditis, pericardial effusion, cardiomyopathy, autoimmune hepatitis, erythema nodosum, autoimmune pancreatitis, hyperpituitarism, hypoparathyroidism, infectious peritonitis, episcleritis, scleritis, Raynaud's phenomenon, palmar-plantar erythrodysaesthesia syndrome, cytokine release syndrome, sarcoidosis,
Slovenian: Pogostnost teh dodatnih neželenih učinkov je bila manjša od 1 %, razen če je navedeno drugače: meningizem, miokarditis, perikardialni izliv, kardiomiopatija, avtoimunski hepatitis, nodozni eritem, avtoimunski pankreatitis, hiperpituitarizem, hipoparatiroidizem, infekcijski peritonitis, episkleritis, skleritis, Raynaudov fenomen, sindrom palmarno-plantarne eritrodisestezije, sindrom sproščanja citokinov, sarkoidoza, znižanje vrednosti gonadotropina v krvi, levkopenija, policitemija, limfocitoza, vnetje očesnih mišic in nevrosenzorična naglušnost.
English: Warnings and precautions Talk to your doctor before using YERVOY as it may cause:
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila YERVOY se posvetujte z zdravnikom.
English: Investigations Common increased alanine aminotransferasec, increased aspartate aminotransferasec, increased blood alkaline phosphatased, increased blood bilirubin, weight decreased Uncommon increased gamma-glutamyltransferased, increased blood creatinine, increased blood thyroid stimulating hormone, decreased blood cortisol, decreased blood corticotrophin, increased lipasec, increased blood amylasec, positive antinuclear antibodyd, decreased blood testosterone
Slovenian: Občasni zvišanje vrednosti gama-glutamiltransferazed, zvišanje vrednosti kreatinina v krvi, zvišanje vrednosti tirotropina, zmanjšanje vrednosti kortizola v krvi, zmanjšanje vrednosti kortikotropina v krvi, zvišanje vrednosti lipazec, zvišanje vrednosti amilaze v krvic, pozitivna protijedrna protitelesad, zmanjšanje vrednosti testosterona v krvi
English: In study CA184070, no immune-related adverse reactions (irAR) ≥Grade 3 were reported for the single patient 12 years of age and older who was treated with ipilimumab 3 mg/kg.
Slovenian: V študiji CA184070 pri nobenem od bolnikov, starih 12 let ali starejših, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg, niso poročali o imunsko pogojenem neželenem učinku stopnje ≥3.
English: Both nivolumab-containing arms demonstrated a significant PFS and OS benefit and greater ORR compared with ipilimumab alone.
Slovenian: Obe skupini zdravljenja z nivolumabom sta pokazali pomembno korist za preživetje brez napredovanja bolezni in celokupno preživetje ter večji delež celokupnega odziva v primerjavi z ipilimumabom samim.
English: Median time to onset was 0.5 months (range: 0.0-19.4).
Slovenian: Mediani čas do pojava je znašal 0,5 meseca (razpon: 0,0-19,4).
English: Grade 2 and Grade 3 thyroid disorders were reported in 15.7% (86/547) and 1.3% (7/547) of patients, respectively.
Slovenian: O boleznih ščitnice stopnje 2 so poročali pri 15,7% (86/547) bolnikov, o boleznih ščitnice stopnje 3 pa pri 1,3 % (7/547) bolnikov.
English: Ipilimumab 3 mg/kg over 90 minutes
Slovenian: infuzije ipilimumab 3 mg/kg v obliki 90-minutne i.v.
English: Once diarrhoea and other symptoms are controlled, the initiation of corticosteroid taper should be based on clinical judgment.
Slovenian: Ko so driska in drugi simptomi pod nadzorom, je treba na osnovi klinične presoje začeti s postopnim zmanjševanjem odmerka kortikosteroidov.
English: For patients with Grade 3 or 4 transaminase or total bilirubin elevation, treatment must be permanently discontinued (see section 4.2), and systemic high-dose intravenous corticosteroid therapy (e.g. methylprednisolone 2 mg/kg daily or equivalent) should be initiated immediately.
Slovenian: Pri bolnikih z zvišanjem vrednosti aminotransferaz ali skupnega bilirubina stopnje 3 ali 4 je treba zdravljenje trajno ukiniti (glejte poglavje 4.2) in nemudoma uvesti sistemsko zdravljenje z visokimi odmerki intravenskih kortikosteroidov (npr. metilprednizolon 2 mg/kg na dan ali ekvivalent).
English: The safety profile of ipilimumab 3 mg/kg in chemotherapy-naive patients pooled across Phase 2 and 3 clinical trials (N= 75; treated), in treatment-naive patients in two retrospective observational studies (N= 273 and N= 157), and in CA184-169 (N= 362) was similar to that in previously-treated advanced melanoma.
Slovenian: Pri bolnikih, ki se še niso zdravili s kemoterapijo (združeni podatki iz kliničnih preskušanj 2. in 3. faze [N= 75; zdravljeni]), pri predhodno nezdravljenih bolnikih (podatki iz dveh retrospektivnih opazovalnih študij [N= 273 in N= 157]) in v študiji CA184-169 (N= 362) je bil varnostni profil ipilimumaba v odmerku 3 mg/kg podoben kot pri bolnikih s predhodno zdravljenim napredovalim melanomom.
English: Adverse reactions reported in the pooled dataset for patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg (n = 448) are presented in Table 5.
Slovenian: Neželeni učinki so v preglednici 5 navedeni na osnovi zbranih podatkov pri bolnikih, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg (n = 448).
English: YERVOY can be used for intravenous administration without dilution or may be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection to concentrations between 1 and 4 mg/ml.
Slovenian: Zdravilo YERVOY se lahko daje intravensko brez predhodnega redčenja ali pa se ga predhodno razredči z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ali s 50 mg/ml (5 %) raztopino glukoze za injiciranje do koncentracije med 1 in 4 mg/ml.
English: NAME OF THE MEDICINAL PRODUCT YERVOY 5 mg/ml sterile concentrate
Slovenian: YERVOY 5 mg/ml sterilni koncentrat ipilimumab
English: Figure 7: Kaplan-Meier curves of OS in intermediate/poor risk patients (CA209214)
Slovenian: Kaplan Meierjevi krivulji celokupnega preživetja pri bolnikih s srednje ugodnim ali slabim prognostičnim obetom (študija CA209214)
English: If resolution to Grades 0-1 or return to baseline occurs, ipilimumab may be resumed (see section 4.2).
Slovenian: Če se stanje izboljša na stopnjo 0-1 ali vzpostavi izhodiščno stanje, se zdravljenje z ipilimumabom lahko nadaljuje (glejte poglavje 4.2).
English: When YERVOY is administered in combination with nivolumab, if either agent is withheld, the other agent should also be withheld.
Slovenian: Pri uporabi zdravila YERVOY v kombinaciji z nivolumabom je treba v primeru zadržanja aplikacije enega zdravila, zadržati tudi aplikacijo drugega zdravila.
English: - histiocytosis haematophagic.
Slovenian: - hematofagno histiocitozo.
English: Systemic high-dose corticosteroid with or without additional immunosuppressive therapy may be required for management of severe immune-related adverse reactions.
Slovenian: V primeru hudih imunsko pogojenih neželenih učinkov bo morda potrebno zdravljenje z visokimi odmerki sistemskih kortikosteroidov z ali brez sočasnega dodatnega zdravljenja z imunosupresivi.
English: Relative to nivolumab monotherapy, an increase in PFS for the combination of ipilimumab with nivolumab is established only in patients with low tumour PD-L1 expression.
Slovenian: V primerjavi z zdravljenjem z nivolumabom v monoterapiji so pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom podaljšanje preživetja brez napredovanja bolezni ugotovili le pri bolnikih z nizko ekspresijo PD-L1 tumorja.
English: Myasthenia gravis-like symptoms have also been reported (see section 4.8).
Slovenian: Poročali so tudi o pojavu simptomov, podobnih miasteniji gravis (glejte poglavje 4.8).
English: Uncommon sarcoidosis
Slovenian: Občasni sarkoidoza
English: When ipilimumab is administered in combination with nivolumab, refer to the Summary of Product Characteristics for nivolumab prior to initiation of treatment.
Slovenian: Pri uporabi ipilimumaba v kombinaciji z nivolumabom pred začetkom zdravljenja preberite tudi povzetek glavnih značilnosti zdravila za nivolumab.
English: After 28 months of follow-up, median durations of response for patients with tumour PD-L1 expression level ≥5% were not reached (range: 0+-31.6+) in the combination arm, not reached (range: 2.8-30.6+) in the nivolumab monotherapy arm and not reached (range: 1.4-30.6+) in the ipilimumab arm. At tumour PD-L1 expression <5%, median durations of response were not reached (range: 0+-33.3+) in the combination arm, not reached (range: 0+-32.3+) in the nivolumab monotherapy arm and 18.2 months (range: 0.0+-31.5+) in the ipilimumab monotherapy arm.
Slovenian: Po 28 mesecih spremljanja pri bolnikih z nivojem ekspresije PD-L1 tumorja ≥ 5 % mediana trajanja odziva v skupini s kombiniranim zdravljenjem ni bila dosežena (razpon: 0+- 31,6+), v skupini zdravljenja z nivolumabom v monoterapiji ni bila dosežena (razpon: 2,8-30,6+), v skupini zdravljenja z ipilimumabom pa prav tako ni bila dosežena (razpon: 1,4-30,6+).
English: Randomised phase 3 study of receive ipilimumab in combination with nivolumab or nivolumab as monotherapy vs. ipilimumab as monotherapy (CA209067)
Slovenian: Randomizirana študija 3. faze za ovrednotenje uporabe ipilimumaba v kombinaciji z nivolumabom ali nivolumaba v monoterapiji v primerjavi z ipilimumabom v monoterapiji (študija CA209067)
English: Treatment-Related Deaths, n
Slovenian: Smrtni izidi, povezani z zdravljenjem, n (%)
English: Ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg
Slovenian: Ipilimumab v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg
English: With protocol-specified management guidelines, resolution (defined as improvement to mild [Grade 1] or less or to the severity at baseline) occurred in most cases (90%), with a median time from onset to resolution of 4 weeks (range 0.6 to 22 weeks).
Slovenian: Mediani čas od pojava do izboljšanja (definirano kot izboljšanje do blage [stopnja 1] jakosti ali manj ali vzpostavitev izhodiščnega stanja) je bil 4 tedne (razpon od 0,6 do 22 tednov).
English: Resolution occurred in 124 patients (93.9%) with a median time to resolution of 5.1 weeks (range: 0.1-106.9).
Slovenian: Do izboljšanja je prišlo pri 124 bolnikih (93,9%), mediani čas do izboljšanja pa je znašal 5,1 tedna (razpon: 0,1-106,9).
English: Common gastrointestinal haemorrhage, colitisb,c, constipation, gastroesophageal reflux disease, abdominal pain, mucosal inflammationd
Slovenian: Pogosti gastrointestinalna krvavitev, kolitisb,c, zaprtost, gastroezofagealni refluks, bolečine v trebuhu, vnetje sluznicd
English: Abnormal kidney function tests (increased amounts of creatinine in your blood) High (hyperglycaemia) or low (hypoglycaemia) sugar levels in the blood A decreased number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot) An increased level of the enzyme that breaks down fats and of the enzyme that breaks down starch Increased or decreased amount of calcium or potassium Increased or decreased blood levels of magnesium or sodium Decrease in body weight
Slovenian: Te spremembe so: nenormalni izvidi preiskav delovanja jeter (zvišanje vrednosti jetrnih encimov aspartat aminotransferaze, alanin aminotransferaze ali alkalne fosfataze v krvi, zvišanje vrednosti bilirubina, odpadnega presnovka v krvi) nenormalni izvidi delovanja ledvic (zvišanje vrednosti kreatinina v krvi) zvišane (hiperglikemija) ali znižane (hipoglikemija) vrednosti sladkorja v krvi zmanjšanje števila rdečih krvnih celic (celice, ki prenašajo kisik), belih krvnih celic (celice, ki so pomembne za obrambo pred okužbami) ali trombocitov (celice, ki so potrebne za normalno strjevanje krvi) zvišanje vrednosti encima, ki razgrajuje maščobe, in zvišanje vrednosti encima, ki razgrajuje škrob zvišanje ali znižanje vrednosti kalcija ali kalija v krvi zvišanje ali znižanje vrednosti magnezija ali natrija v krvi zmanjšanje telesne mase
English: Cases of myotoxicity (myositis, myocarditis, and rhabdomyolysis), some with fatal outcome, have been reported with ipilimumab in combination with nivolumab.
Slovenian: Pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom so poročali o primerih toksičnosti za mišice (miozitis, miokarditis in rabdomioliza), nekateri od njih so se končali s smrtnim izidom.
English: Hepatic:
Slovenian: Jetra:
English: Uncommon hepatic failureb,c, hepatitis, hepatomegaly, jaundice Skin and subcutaneous tissue disorders Very common rashc, pruritusc
Slovenian: Občasni odpoved jeterb,c, hepatitis, hepatomegalija, zlatenica Bolezni kože in podkožja Zelo pogosti izpuščajc, srbenjec
English: No statistically significant difference in progression free survival (PFS) was observed between the 10 mg/kg and the 3 mg/kg groups.
Slovenian: Med skupinama z odmerkom 10 mg/kg in odmerkom 3 mg/kg niso opazili statistično značilne razlike pri preživetju brez napredovanja bolezni (PFS-progression-free survival).
English: For symptomatic hyperthyroidism, ipilimumab in combination with nivolumab should be withheld and antithyroid medication should be initiated as needed.
Slovenian: V primeru simptomatskega hipertiroidizma je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati in po potrebi uvesti antitiroidno zdravljenje.
English: YERVOY as monotherapy Melanoma
Slovenian: Zdravilo YERVOY v monoterapiji Melanom
English: Based on the severity of the adverse reaction, ipilimumab in combination with nivolumab should be withheld and corticosteroids administered.
Slovenian: Na osnovi resnosti neželenega učinka je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati in uvesti zdravljenje s kortikosteroidi.
English: Each 10 ml vial of YERVOY concentrate provides 50 mg of ipilimumab; each 40 ml vial provides 200 mg of ipilimumab.
Slovenian: Ena 10-ml viala s koncentratom zdravila YERVOY vsebuje 50 mg ipilimumaba, ena 40-ml viala pa 200 mg ipilimumaba.
English: The estimated 1-year, 2-year and 3-year survival rates for chemotherapy-naive patients (N= 78) pooled across Phase 2 and 3 clinical trials were 54.1% (95% CI: 42.5 - 65.6), 31.6% (95% CI: 20.7 - 42.9) and 23.7% (95% CI: 14.3 - 34.4) respectively.
Slovenian: Pri bolnikih, ki se še niso zdravili s kemoterapijo (združeni podatki iz kliničnih preskušanj 2. in 3. faze [N= 78]), je ocenjeni delež 1-letnega preživetja znašal 54,1 % (95 % interval zaupanja: 42,5 - 65,6), ocenjeni delež 2-letnega preživetja je znašal 31,6 % (95 % interval zaupanja: 20,7 - 42,9), ocenjeni delež 3-letnega preživetja pa je znašal 23,7 % (95 % interval zaupanja:
English: For Grade 2 diarrhoea or colitis, ipilimumab in combination with nivolumab should be withheld.
Slovenian: V primeru driske ali kolitisa stopnje 2 je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati.
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 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 1 do 2 mg/kg/dan metilprednizolona, zdravljenje z ipilimumabom v kombinaciji z nivolumabom pa trajno ukiniti.
English: Median (95% CI)
Slovenian: Mediana (95% IZ)
English: For symptomatic Grade 2 adrenal insufficiency, ipilimumab in combination with nivolumab should be withheld, and physiologic corticosteroid replacement should be initiated as needed.
Slovenian: V primeru simptomatske insuficience nadledvičnih žlez stopnje 2 je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati in po potrebi uvesti zdravljenje s fiziološkim nadomeščanjem kortikosteroidov.
English: The chemical and physical in-use stability of the undiluted or diluted infusion solution (between 1 and 4 mg/ml) has been demonstrated for 24 hours at room temperature (20°C to 25°C) or when refrigerated (2°C to 8°C).
Slovenian: Dokazano je bilo, da je nerazredčen ali razredčen koncentrat (med 1 in 4 mg/ml) kemijsko in fizikalno stabilen 24 ur, če se ga shranjuje pri sobni temperaturi (20 °C do 25 °C) ali v hladilniku (2 °C do 8 °C).
English: The safety and efficacy of YERVOY have not been studied in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic varnosti in učinkovitosti zdravila YERVOY niso raziskovali.
English: The chemical and physical in-use stability of the undiluted or diluted concentrate (between 1 and 4 mg/ml) has been demonstrated for 24 hrs at 25°C and 2°C to 8°C.
Slovenian: Dokazano je bilo, da je nerazredčen ali razredčen koncentrat (med 1 in 4 mg/ml) kemijsko in fizikalno stabilen 24 ur, če se ga shranjuje pri temperaturi do 25 °C ali pri temperaturi med 2 °C in 8 °C.
English: Ipilimumab must be permanently discontinued in patients with severe (Grade 3 or 4) sensory neuropathy suspected to be related to ipilimumab (see section 4.2).
Slovenian: Pri bolnikih s hudo (stopnja 3 ali 4) senzorično nevropatijo, ki je domnevno povezana z uporabo ipilimumaba, je treba zdravljenje z ipilimumabom ukiniti (glejte poglavje 4.2).
English: PD-L1 expression ≥ 5%
Slovenian: Ekspresija PD-L1 ≥ 5%
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of pneumonitis including interstitial lung disease was 6.2% (34/547).
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 pnevmonitisa, vključno z boleznijo pljučnega intersticija, znašala 6,2 % (34/547).
English: nivolumab + ipilimumab Median OS (95% CI)
Slovenian: nivolumab + ipilimumab Mediana OS (95% IZ)
English: Median time to onset was 2.6 months (range: 0.7-12.6).
Slovenian: Mediani čas do pojava je znašal 2,6 meseca (razpon: 0,7-12,6).
English: In addition, the following uncommon (may affect up to 1 in 100 people) side effects have been reported in patients who received doses other than 3mg/kg of YERVOY in clinical trials:
Slovenian: Pri bolnikih, ki so v kliničnih preskušanjih prejemali odmerke drugačne kot 3 mg/kg zdravila YERVOY, so poročali še o naslednjih občasnih neželenih učinkih (lahko se pojavijo pri največ 1 od 100 bolnikov):
English: Median time to onset was 1.5 months (range: 0.0-30.1).
Slovenian: Mediani čas do pojava je znašal 1,5 meseca (razpon: 0,0-30,1).