FrancophonIA/ELRC3.0 huggingface dataset:
English: If pituitary imaging or laboratory tests of endocrine function are abnormal, a short course of high-dose corticosteroid therapy (e.g. dexamethasone 4 mg every 6 hrs or equivalent) is recommended to treat the inflammation of the affected gland, and the scheduled dose of ipilimumab should be withheld (see section 4.2).
Slovenian: Če slikovne preiskave hipofize ali testi endokrine funkcije niso normalni, je za zdravljenje vnetja prizadete žleze priporočljiva kratkotrajna uporaba visokih odmerkov kortikosteroidov (npr. deksametazon v odmerku 4 mg na vsakih 6 ur ali ekvivalent), naslednji predvideni odmerek ipilimumaba pa je treba zadržati (glejte poglavje 4.2).
English: The safety and efficacy of ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg for the treatment of advanced/metastatic RCC was evaluated in a phase 3, randomised, open-label study (CA209214).
Slovenian: Varnost in učinkovitost ipilimumaba v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg pri zdravljenju napredovalega/metastatskega RCC so vrednotili v randomizirani, odprti študiji 3. faze (študija CA209214).
English: When administered in combination with nivolumab, nivolumab should be given first followed by YERVOY on the same day.
Slovenian: Pri uporabi zdravila v kombinaciji z nivolumabom je treba najprej aplicirati nivolumab, nato pa sledi še aplikacija zdravila YERVOY na isti dan.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of ipilimumab (see section 4.4 for management of immune-related adverse reactions).
Slovenian: Večina teh neželenih učinkov, vključno z resnimi neželenimi učinki, je minila po uvedbi ustreznega zdravljenja ali prekinitvi zdravljenja z ipilimumabom (za ukrepanje v primeru pojava imunsko pogojenih neželenih učinkov glejte poglavje 4.4).
English: Of patients 12 years of age and older with advanced melanoma, ipilimumab 5 mg/kg was administered to three patients and ipilimumab 10 mg/kg was administered to two patients.
Slovenian: Pri bolnikih, starih 12 let in starejših, z napredovalim melanomom, so ipilimumab v odmerku 5 mg/kg prejemali trije bolniki, ipilimumab v odmerku 10 mg/kg pa dva bolnika.
English: Immune-related endocrinopathy observed in clinical trials was generally controlled with hormone replacement therapy.
Slovenian: Imunsko pogojene endokrinopatije, opažene v kliničnih preskušanjih, so se običajno dobro odzvale na hormonsko nadomestno zdravljenje.
English: Signs and symptoms may include redness in the eye, pain in the eye, vision problems, blurry vision or temporary loss of sight.
Slovenian: Znaki in simptomi lahko vključujejo rdečino oči, bolečino v očesu, težave z vidom, zamegljen vid ali začasno izgubo vida.
English: The safety and efficacy of YERVOY in children younger than 12 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila YERVOY pri otrocih, mlajših od 12 let, nista bili dokazani.
English: Your doctor may give you other medicines in order to prevent more severe complications and reduce your symptoms, withhold the next dose of YERVOY, or stop your treatment with YERVOY altogether.
Slovenian: Da bi preprečil hujše zaplete in ublažil simptome vam bo zdravnik morda predpisal uporabo drugih zdravil, zadržal naslednji odmerek zdravila ali pa zdravljenje z zdravilom YERVOY ukinil.
English: In clinical trials, mycophenolate mofetil was used in patients without response to corticosteroid therapy, or who had an LFT elevation during corticosteroid tapering that was not responsive to an increase in the dose of corticosteroids (see the Summary of Product Characteristics for mycophenolate mofetil).
Slovenian: V kliničnih preskušanjih so pri bolnikih brez odziva na zdravljenje s kortikosteroidi in pri bolnikih, ki so imeli zvišane vrednosti jetrnih testov med zmanjševanjem odmerka kortikosteroidov in se niso odzvali na povečanje odmerka kortikosteroida, uporabili mofetilmikofenolat (glejte povzetek glavnih značilnosti zdravila za mofetilmikofenolat).
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
Slovenian: Opomba: Stopnje toksičnosti so navedene v skladu z različico 4.0 terminološko poenotenih kriterijev neželenih učinkov ameriškega Nacionalnega onkološkega inštituta (NCI CTCAE v4; National Cancer Institute Common
English: CL was not affected by age (range 23-88 years), gender, concomitant use of budesonide or dacarbazine, performance status, HLA-A2*0201 status, mild hepatic impairment, renal impairment,
Slovenian: Starost (razpon od 23 do 88 let), spol, sočasna uporaba budezonida ali dakarbazina, stanje telesne zmogljivosti, status HLA A2*0201, blaga okvara jeter, okvara ledvic, imunogenost in predhodno zdravljenje raka niso vplivali na očistek.
English: Life-threatening cases have been reported in completed or ongoing clinical studies.
Slovenian: V končanih študijah ali študijah, ki še potekajo, so poročali o življenjsko ogrožujočih primerih.
English: A drug-interaction study in adults of ipilimumab administered alone and in combination with chemotherapy (dacarbazine or paclitaxel/carboplatin) was conducted evaluating interaction with CYP isozymes (particularly CYP1A2, CYP2E1, CYP2C8, and CYP3A4) in patients with treatment-naive advanced melanoma.
Slovenian: V študiji, v kateri so bolniki prejemali ipilimumab sam ali v kombinaciji z drugimi kemoterapevtiki (dakarbazin ali paklitaksel/karboplatin), so vrednotili interakcije z izoencimi CYP (predvsem CYP1A2, CYP2E1, CYP2C8 in CYP3A4).
English: Administer the YERVOY infusion intravenously over a period of 30 or 90 minutes, depending on the dose.
Slovenian: YERVOY raztopino za infundiranje morate aplicirati v obliki 30-minutne ali 90-minutne intravenske infuzije, odvisno od odmerka.
English: Patients must be evaluated for evidence of gastrointestinal perforation or peritonitis.
Slovenian: Bolnike je treba ovrednotiti glede znakov perforacije v prebavilih ali peritonitisa.
English: Randomised phase 2 study of ipilimumab in combination with nivolumab and ipilimumab (CA209069)
Slovenian: Randomizirana študija 2. faze za ovrednotenje ipilimumaba v kombinaciji z nivolumabom in ipilimumaba (študija CA209069)
English: In most reported cases prior or concurrent therapy with a PD-1 or PD-L1 inhibitor has occurred.
Slovenian: V večini sporočenih primerov je šlo za predhodno ali sočasno zdravljenje z zaviralcem PD-1 ali PD-L1.
English: Children and adolescents YERVOY should not be used in children below 12 years of age.
Slovenian: Otroci in mladostniki Zdravila YERVOY se ne sme uporabljati pri otrocih, mlajših od 12 let.
English: No treatment-related adverse effects on reproduction were detected during the first two trimesters of pregnancy.
Slovenian: Med prvima dvema trimesečjema brejosti vplivov zdravila na sposobnost razmnoževanja niso zasledili.
English: Additionally, for patients who experienced an event, Table 6 presents the percentage of patients who required high-dose corticosteroids (at least 40 mg daily prednisone equivalents).
Slovenian: V preglednici 6 so predstavljeni tudi deleži bolnikov, pri katerih se je pojavil neželeni učinek in so potrebovali velike odmerke kortikosteroidov (odmerki, ki ustrezajo vsaj 40 mg prednizona dnevno).
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Patients were randomized in a 3:1:1 ratio to receive ipilimumab 3 mg/kg + an investigational gp100 peptide vaccine (gp100), ipilimumab 3 mg/kg monotherapy, or gp100 alone.
Slovenian: Bolniki so bili randomizirani v razmerju 3:1:1 tako, da so prejemali ipilimumab v odmerku 3 mg/kg v kombinaciji s preiskovanim peptidnim cepivom gp100 (gp100), samo ipilimumab v odmerku 3 mg/kg ali samo gp100.
English: Among the 382 patients in this group who continued treatment in the single-agent phase, 144 (38%) experienced at least one Grade 3 or 4 adverse reaction during the single-agent phase.
Slovenian: Med 382 bolniki iz te skupine, ki so zdravljenje nadaljevali v fazi zdravljenja z enim samim zdravilom, se je med fazo zdravljenja z enim samim zdravilom pri 144 bolnikih (38%) pojavil vsaj en neželeni učinek stopnje 3 ali 4.
English: Patients with a mild to moderate (Grade 1 or 2) rash may remain on ipilimumab therapy with symptomatic treatment (e.g. antihistamines).
Slovenian: Pri bolnikih z blagim do zmernim izpuščajem (stopnja 1 ali 2) se zdravljenje z ipilimumabom lahko nadaljuje ob sočasnem simptomatskem zdravljenju (npr. z antihistaminiki).
English: Figure 1: Overall Survival with ipilimumab 3 mg/kg in pooled analysis
Slovenian: Slika 1: Celokupno preživetje v analizi z ipilimumabom 3 mg/kg
English: Decision whether to discontinue YERVOY should be based on severity.
Slovenian: Odločitev o ukinitvi zdravljenja z zdravilom YERVOY je treba sprejeti na osnovi resnosti učinka.
English: Based on the severity of myotoxicity, ipilimumab in combination with nivolumab should be withheld or discontinued (see section 4.2), and appropriate treatment instituted.
Slovenian: Na osnovi resnosti toksičnosti za mišice je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati ali ukiniti (glejte poglavje 4.2) in uvesti ustrezno zdravljenje.
English: Vogt-Koyanagi-Harada syndromee, serous retinal detachment Cardiac disorders
Slovenian: Vogt-Koyanagi-Haradov sindrome, serozni odstop mrežnice
English: Once a diagnosis of myocarditis is established, ipilimumab in combination with nivolumab should be withheld or permanently discontinued (see section 4.2).
Slovenian: Če se diagnoza miokarditisa potrdi, je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati ali trajno ukiniti (glejte poglavje 4.2).
English: Before initiating treatment with the combination, physicians are advised to carefully evaluate the individual patient and tumour characteristics, taking into consideration the observed benefits and the toxicity of the combination relative to nivolumab monotherapy (see sections 4.8 and 5.1).
Slovenian: Pred uvedbo kombiniranega zdravljenja mora zdravnik skrbno ovrednotiti posameznega bolnika in lastnosti tumorja, pri čemer mora upoštevati znane koristi in toksične učinke kombinacije v primerjavi z zdravljenjem z nivolumabom v monoterapiji (glejte poglavji 4.8 in 5.1).
English: Severe symptoms (abdominal pain, severe diarrhoea or significant change in the number of stools, blood in stool, gastrointestinal haemorrhage, gastrointestinal perforation)
Slovenian: Prebavila: hudi simptomi (bolečine v trebuhu, huda driska ali pomembna sprememba v številu odvajanj blata, kri v blatu, krvavitev v prebavilih, perforacija v prebavilih)
English: From a microbiological point of view, once opened, the medicine should be infused or diluted and infused immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo infundirati ali razredčiti in infundirati takoj po odprtju viale.
English: Ipilimumab in combination with nivolumab (see section 4.2)
Slovenian: Ipilimumab v kombinaciji z nivolumabom (glejte poglavje 4.2)
English: Each ml of concentrate contains 0.1 mmol sodium, which is 2.30 mg sodium.
Slovenian: En ml koncentrata vsebuje 0,1 mmol natrija, kar ustreza 2,30 mg natrija.
English: If symptoms or signs of SJS or TEN appear, treatment with ipilimumab in combination with nivolumab should be discontinued and the patient referred to a specialised unit for assessment and treatment.
Slovenian: V primeru pojava simptomov ali znakov SJS ali TEN je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom ukiniti, bolnika pa napotiti k ustreznemu specialistu na nadaljnje preiskave in zdravljenje.
English: Unless otherwise specified, the data below reflect exposure to ipilimumab at 3 mg/kg in clinical trials of melanoma.
Slovenian: Če ni navedeno drugače, se podatki v nadaljevanju nanašajo na uporabo ipilimumaba v odmerku 3 mg/kg v kliničnih preskušanjih uporabe zdravila pri melanomu.
English: For patients who required re-treatment, the BORR was 38% (3/8 patients) in the ipilimumab monotherapy group, and 0% in the gp100 group.
Slovenian: Pri bolnikih, ki so potrebovali ponovno zdravljenje, je najboljši celokupni delež odziva znašal 38 % (3/8 bolnikov) v skupini, ki je prejemala ipilimumab kot monoterapijo, in 0 % v skupini, ki je prejemala samo gp100.
English: Evaluation of laboratory results to assess endocrine function may be performed before corticosteroid therapy is initiated.
Slovenian: Pred uvedbo zdravljenja s kortikosteroidi se lahko ovrednoti laboratorijske rezultate endokrine funkcije.
English: CA184004/007 Pooled
Slovenian: Združeni podatki študij CA184004/007
English: Overall survival compared between Ipilimumab 10 mg/kg and 3 mg/kg groups showed HR = 0.84 (95% CI: 0.70, 0.99; P-value = 0.04).
Slovenian: Celokupno preživetje pri primerjavi med skupino z ipilimumabom v odmerku 10 mg/kg in skupino z ipilimumabom v odmerku 3 mg/kg kaže razmerje ogroženosti (HR-hazard rate) = 0,84 (95 % interval zaupanja: 0,70; 0,99; Pvrednost = 0,04).
English: A total of 727 patients were randomized, 362 to receive ipilimumab 3 mg/kg and 365 to receive ipilimumab 10 mg/kg every 3 weeks for 4 doses.
Slovenian: V celoti je bilo randomiziranih 727 bolnikov: 362 bolnikov je prejemalo ipilimumab v odmerku 3 mg/kg, 365 bolnikov pa je prejemalo ipilimumab v odmerku 10 mg/kg vsake 3 tedne, skupaj 4 odmerke.
English: Common pneumonitisa,c, pulmonary embolisma, cough pneumonitis, dyspnoea, pleural effusion, cough
Slovenian: Pogosti pnevmonitisa,c, pljučna embolijaa, kašelj pnevmonitis, dispneja, plevralni izliv, kašelj
English: * ipilimumab in combination with nivolumab for the first 4 doses then followed by nivolumab monotherapy in melanoma.
Slovenian: * ipilimumab v kombinaciji z nivolumabom za prve 4 odmerke in nato nivolumab v monoterapiji pri zdravljenju melanoma.
English: In such patients, LFTs must be monitored until normalization.
Slovenian: Pri takšnih bolnikih je treba nadzirati vrednosti jetrnih testov do izboljšanja.
English: The following immune-related adverse reactions were reported in less than 1% of patients treated with ipilimumab in combination with nivolumab 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 ipilimumabom v kombinaciji z nivolumabom v različnih odmerkih in pri različnih vrstah 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: Based on these preliminary data, the concurrent administration of ipilimumab and vemurafenib is not recommended.
Slovenian: Na osnovi teh preliminarnih podatkov sočasna uporaba ipilimumaba in vemurafeniba ni priporočljiva.
English: Ipilimumab 3 mg/kg was administered to four patients and ipilimumab 10 mg/kg was administered to eight patients.
Slovenian: Ipilimumab v odmerku 3 mg/kg so prejemali štirje bolniki, ipilimumab v odmerku 10 mg/kg pa osem bolnikov.
English: Severe adverse reactions in the endocrine glands, such as hypophysitis and thyroiditis that are not adequately controlled with hormone replacement therapy or high-dose immunosuppressive therapy
Slovenian: Endokrini sistem: hudi neželeni učinki na endokrine žleze, kot sta vnetje hipofize ali vnetje ščitnice, ki s hormonskim nadomestnim zdravljenjem ali z zdravljenjem z visokimi odmerki imunosupresivov niso ustrezno nadzorovani
English: Liver biopsies from patients who had immune-related hepatotoxicity showed evidence of acute inflammation (neutrophils, lymphocytes, and macrophages).
Slovenian: Biopsija jeter pri bolnikih z imunsko pogojeno hepatotoksičnostjo je pokazala znake akutnega vnetja (nevtrofilce, limfocite in makrofage).
English: In clinical trials, rapid tapering (over periods < 1 month) resulted in recurrence of diarrhoea or colitis in some patients.
Slovenian: V kliničnih preskušanjih sta se pri hitrem zmanjšanju odmerka (v obdobju, krajšem od enega meseca) driska ali kolitis pri posameznih bolnikih ponovila.
English: When YERVOY is given alone for the treatment of skin cancer, YERVOY will be given to you as an infusion (a drip) into a vein (intravenously) over a period of 90 minutes.
Slovenian: Pri zdravljenju kožnega raka boste zdravilo YERVOY samostojno prejeli v obliki 90-minutne kapljične infuzije v veno (intravensko).
English: Among 128 patients who discontinued ipilimumab in combination with nivolumab 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 ipilimumabom v kombinaciji z nivolumabom zaradi neželenih učinkov prekinjeno, je po 18 mesecih spremljanja mediana PFS znašala 16,7 meseca (95 % interval zaupanja: 10,2; NP).
English: Patients with ocular melanoma, active brain metastases and prior therapy with CTLA-4, PD-1, PD-L1, or CD137 targeted agents were not included in the paediatric trial CA184178 (see section 5.1).
Slovenian: Bolniki z očesnim melanomom, bolniki z aktivnimi zasevki v možganih in bolniki, ki so se predhodno zdravili s CTLA-4, PD-1, PD-L1 ali CD137 tarčnimi zdravili, niso bili vključeni v pediatrično preskušanje CA184178 (glejte poglavje 5.1).
English: BORR in the 10 mg/kg group was 15.3% (95% CI: 11.8, 19.5) and in the 3 mg/kg group was 12.2% (95% CI: 9.0, 16.0).
Slovenian: BORR je v skupini z odmerkom 10 mg/kg znašal 15,3 % (95 % interval zaupanja: 11,8; 19,5), v skupini z odmerkom 3 mg/kg pa 12,2 % (95 % interval zaupanja: 9,0; 16,0).
English: YERVOY infusion
Slovenian: infuzije
English: If there are any signs of adrenal crisis such as severe dehydration, hypotension, or shock, immediate administration of intravenous corticosteroids with mineralocorticoid activity is recommended, and the patient must be evaluated for presence of sepsis or infections.
Slovenian: V primeru pojava katerega koli znaka adrenalne krize, kot so huda dehidracija, hipotenzija ali šok, je priporočljivo nemudoma aplicirati intravenske kortikosteroide z mineralokortikoidno aktivnostjo.
English: DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
Slovenian: Za DRESS je značilen izpuščaj z eozinofilijo v povezavi z enim ali več od naslednjih simptomov: zvišana telesna temperatura, limfadenopatija, edem obraza in prizadetost notranjih organov (jetra, ledvice, pljuča).
English: Baseline characteristics were well balanced across groups.
Slovenian: Izhodiščne značilnosti so bile po skupinah dobro uravnovešene.
English: Rare serous retinal detachment serous retinal detachment
Slovenian: Redki serozni odstop mrežnice serozni odstop mrežnice
English: In case of a severe or life-threatening infusion reaction, the ipilimumab or ipilimumab in combination with nivolumab infusion must be discontinued and appropriate medical therapy administered.
Slovenian: V primeru pojava hude ali življenje ogrožajoče infuzijske reakcije je treba infundiranje ipilimumaba ali ipilimumaba v kombinaciji z nivolumabom prekiniti in uvesti ustrezno zdravljenje.
English: If you have any further questions about your treatment or the use of this medicine, ask your doctor.
Slovenian: Če imate o zdravljenju ali uporabi zdravila dodatna vprašanja, se posvetujte z zdravnikom.
English: At the time of this analysis, medians were not reached for patients with CR or PR.
Slovenian: V času te analize mediane vrednosti pri bolnikih s popolnim ali delnim odzivom niso bile dosežene.
English: In clinical trials, liver biopsies from patients who had immune-related hepatotoxicity showed evidence of acute inflammation (neutrophils, lymphocytes, and macrophages).
Slovenian: V kliničnih preskušanjih je biopsija jeter pri bolnikih z imunsko pogojenimi hepatotoksičnimi učinki pokazala znake akutnega vnetja (nevtrofilce, limfocite in makrofage).
English: Do not stop treatment with YERVOY unless you have discussed this with your doctor.
Slovenian: Zdravljenja z zdravilom YERVOY ne smete prekiniti, ne da bi se o tem najprej posvetovali z zdravnikom.
English: Long term survival benefit of treatment with ipilimumab (at 3mg/kg) is demonstrated through a pooled analysis of OS data from clinical trials in patients with previously treated and treatment naive advanced melanoma (N = 965).
Slovenian: Korist za celokupno preživetje pri zdravljenju z ipilimumabom (3 mg/kg) je bila dokazana z analizo celokupnega preživetja v kliničnih preskušanjih pri predhodno zdravljenih bolnikih in pri predhodno nezdravljenih bolnikih z napredovalim melanomom (N = 965).
English: YERVOY should not be used in children younger than 12 years of age.
Slovenian: Zdravila YERVOY se pri otrocih, mlajših od 12 let, ne sme uporabljati.
English: A group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour lysis syndrome) An inflammatory disorder (most likely of autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt-Koyanagi-Harada syndrome) Inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial disorders)
Slovenian: Skupek presnovnih zapletov, ki se pojavijo po zdravljenju raka, za katere so značilne visoke vrednosti kalija in fosfata v krvi ter nizke vrednosti kalcija v krvi (sindrom tumorske lize) Vnetna bolezen (najverjetneje avtoimunskega porekla), ki prizadene oči, kožo ter ovojnice ušes, možganov in hrbtenjače (Vogt Koyanagi Haradov sindrom) Vnetje mrene, ki obdaja srce, in nabiranje tekočine okrog srca (bolezni perikardija)
English: Thirty-two patients received re-treatment: 8 in the ipilimumab monotherapy group, 23 in the ipilimumab + gp100 group, and 1 in the gp100 group.
Slovenian: Ponovno zdravljenje je bilo uvedeno pri 32 bolnikih: 8 v skupini, ki je prejemala samo ipilimumab, 23 v skupini, ki je prejemala ipilimumab + gp100, in 1 bolniku v skupini, ki je prejemala samo gp100.
English: Patients with ocular melanoma, primary CNS melanoma, active brain metastases, human immunodeficiency virus (HIV), hepatitis B, and hepatitis C were not included in the MDX010-20 clinical trial.
Slovenian: Bolniki z očesnim melanomom, bolniki s primarnim melanomom v osrednjem živčevju, bolniki z aktivnimi zasevki v možganih, bolniki z okužbo z virusom humane imunske pomanjkljivosti (HIV), bolniki s hepatitisom B in bolniki s hepatitisom C niso bili vključeni v klinično preskušanje MDX010-20.
English: b. Tabulated list of adverse reactions
Slovenian: b. Tabelarični pregled neželenih učinkov
English: What YERVOY looks like and contents of the pack YERVOY concentrate for solution for infusion is clear to slightly opalescent, colourless to pale yellow and may contain light (few) particulates.
Slovenian: Izgled zdravila YERVOY in vsebina pakiranja YERVOY koncentrat za raztopino za infundiranje je bistra do rahlo opalescentna, brezbarvna do svetlorumena tekočina, ki lahko vsebuje manjše število neznatnih delcev.
English: No new or unexpected irARs were observed in this study.
Slovenian: V tej študiji niso opazili novih ali nepričakovanih imunsko pogojenih neželenih učinkov.
English: If severe (Grade 3 or 4), these reactions may require immediate systemic high-dose corticosteroid therapy and discontinuation of ipilimumab (see section 4.2).
Slovenian: Če so ti učinki hudi (stopnja 3 ali 4), jih bo morda treba nemudoma zdraviti z visokimi odmerki sistemskih kortikosteroidov in prekiniti zdravljenje z ipilimumabom (glejte poglavje 4.2).