FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic transaminase and bilirubin must be evaluated before each dose of ipilimumab, as early laboratory changes may be indicative of emerging immune-related hepatitis (see section 4.2).
Slovenian: Pred vsako aplikacijo odmerka ipilimumaba je treba ovrednotiti vrednosti jetrnih aminotransferaz in bilirubina, saj zgodnje laboratorijske spremembe lahko kažejo na pojav imunsko pogojenega hepatitisa (glejte poglavje 4.2).
English: - inflammation of the intestines (colitis) which can worsen to bleedings or bowel perforation.
Slovenian: - vnetje črevesa (kolitis), ki se lahko poslabša do pojava krvavitev ali predrtja črevesa.
English: In some cases, addition of other immunosuppressive therapy may be considered (see section 4.4).
Slovenian: Pri posameznih bolnikih bo morda potrebno še dodatno imunosupresivno zdravljenje (glejte poglavje 4.4).
English: Table 12: Efficacy results in intermediate/poor risk patients (CA209214)
Slovenian: Preglednica 12: Rezultati učinkovitosti pri bolnikih s srednje ugodnim ali slabim prognostičnim obetom (študija CA209214)
English: The types of irARs were consistent with the adult experience, with the most commonly reported irARs across all groups in the categories of gastrointestinal (0 [3 mg/kg], 62.5% [5 mg/kg], and 44.4% [10 mg/kg]), hepatic function (0 [3 mg/kg], 75.0% [5 mg/kg], 33.3% [10 mg/kg]), and skin (0 [3 mg/kg], 25.0% [5 mg/kg], 33.3% [10 mg/kg]) events.
Slovenian: Vrsta imunsko pogojenih neželenih učinkov je bila konsistentna z izkušnjami pri odraslih, najpogosteje poročani imunsko pogojeni neželeni učinki po vseh skupinah pa so bili povezani s prebavili (0 [3 mg/kg]; 62,5 % [5 mg/kg] in 44,4 % [10 mg/kg]), z delovanjem jeter (0 [3 mg/kg]; 75,0 % [5 mg/kg]; 33,3 % [10 mg/kg]) in s kožo (0 [3 mg/kg]; 25,0 % [5 mg/kg]; 33,3 % [10 mg/kg]).
English: Clinical trials excluded patients with ECOG performance status > 1 and mucosal melanoma.
Slovenian: Iz kliničnih preskušanj so bili izključeni bolniki s telesno zmogljivostjo po ECOG >1 in sluzničnim melanomom.
English: Neutralising antibodies against ipilimumab were not detected.
Slovenian: Nevtralizirajočih protiteles proti ipilimumabu niso ugotovili.
English: Recommended treatment modifications for YERVOY in combination with nivolumab or administration of the second phase of treatment (nivolumab monotherapy) following combination treatment
Slovenian: Priporočene prilagoditve zdravljenja z zdravilom YERVOY v kombinaciji z nivolumabom ali druge faze zdravljenja (nivolumab v monoterapiji) po kombiniranem zdravljenju
English: - - -*- - - - Nivolumab+ipilimumab (events: 161/314), median and 95% CI: 11.50 (8.90, 22.18).
Slovenian: - - -*- - - - nivolumab+ipilimumab (dogodki: 161/314), mediana in 95% IZ: 11,50 (8,90; 22,18).
English: In patients with melanoma who received ipilimumab, the mean peripheral blood absolute lymphocyte counts (ALC) increased throughout the induction dosing period.
Slovenian: Pri bolnikih z melanomom, ki so prejemali ipilimumab, se je povprečno absolutno število limfocitov v periferni krvi med indukcijskim zdravljenjem ves čas povečevalo.
English: When YERVOY is given following prior vemurafenib there may be an increased risk of skin side-effects.
Slovenian: Če boste prejeli zdravilo YERVOY po predhodnem zdravljenju z vemurafenibom, se lahko poveča tveganje za pojav neželenih učinkov na kožo.
English: Ipilimumab alone is used to treat advanced melanoma (a type of skin cancer) in adults and adolescents 12 years of age and older.
Slovenian: Ipilimumab samostojno uporabljamo za zdravljenje napredovalega melanoma (vrsta kožnega raka) pri odraslih in mladostnikih, starih 12 let in starejših.
English: - Inflammation of the muscles such as myocarditis (inflammation of the heart muscle), myositis (inflammation of the muscles) and rhabdomyolysis (stiffness in muscles and joints, muscle spasm).
Slovenian: - vnetje mišic, kot so miokarditis (vnetje srčne mišice), miozitis (vnetje mišic) in rabdomioliza (okorelost mišic in sklepov, mišični krč).
English: Fatal toxic epidermal necrolysis (including SJS) has been reported in < 1% of patients who received ipilimumab in combination with gp100 (see section 5.1).
Slovenian: O usodni toksični epidermalni nekrolizi (vključno s SJS) so poročali pri manj kot 1 % bolnikov, ki so ipilimumab prejeli v kombinaciji z gp100 (glejte poglavje 5.1).
English: Patients with mild to moderate (Grade 1 or 2) diarrhoea (an increase of up to 6 stools per day) or suspected mild to moderate colitis (e.g. abdominal pain or blood in stools) may remain on ipilimumab.
Slovenian: Pri bolnikih z blago do zmerno (stopnja 1 ali 2) drisko (povečanje števila odvajanj blata do 6 na dan) ali domnevnim blagim do zmernim kolitisom (npr. bolečine v trebuhu ali kri v blatu) se zdravljenje z ipilimumabom lahko nadaljuje.
English: Table 4: Adverse reactions in patients with advanced melanoma treated with ipilimumab 3 mg/kg (n= 767)a
Slovenian: Preglednica 4: Neželeni učinki pri bolnikih z napredovalim melanomom, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg (n= 767)a
English: - Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes).
Slovenian: - sladkorno bolezen (simptomi vključujejo prekomerno žejo, izločanje večje količine urina, povečan apetit z zmanjšanjem telesne mase, občutek utrujenosti, zaspanosti, oslabelosti, depresije, razdražljivosti in splošnega slabega počutja) ali diabetično ketoacidozo (kopičenje kisline v krvi zaradi sladkorne bolezni).
English: Ipilimumab may selectively deplete T-regulatory cells at the tumour site, leading to an increase in the intratumoral T-effector/ T-regulatory cell ratio which drives tumour cell death.
Slovenian: Ipilimumab lahko selektivno zmanjša količino regulatornih celic T na mestu tumorja, s čimer se poveča razmerje med efektorskimi celicami T in regulatornimi celicami T znotraj tumorja, kar povzroči odmrtje tumorskih celic.
English: A Phase 3, double-blind study enrolled patients with previously treated or untreated unresectable Stage III or Stage IV melanoma.
Slovenian: Dvojno slepa študija 3. faze je vključevala bolnike s predhodno zdravljenim ali nezdravljenim neoperabilnim melanomom stadija III ali stadija IV.
English: Upon improvement, ipilimumab may be resumed (see section 4.2).
Slovenian: Po izboljšanju se zdravljenje z ipilimumabom lahko nadaljuje (glejte poglavje 4.2).
English: Subsequent immunotherapy (including anti-PD1 therapy, anti-CTLA-4 antibody, or other immunotherapy) was received by 14.6%, 29.1%, and 44.1% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Slovenian: V skupini s kombiniranim zdravljenjem se je naknadno z imunoterapijo (vključno z anti-PD1, anti-CTLA-4 protitelesi ali drugo obliko imunoterapije) zdravilo 14,6 % bolnikov, v skupini zdravljenja z nivolumabom v monoterapiji 29,1 % bolnikov, v skupini zdravljenja z ipilimumabom pa 44,1 % bolnikov.
English: Once symptoms or laboratory abnormalities are controlled and overall patient improvement is evident, treatment with ipilimumab may be resumed and initiation of corticosteroid taper should be based on clinical judgment.
Slovenian: Ko so simptomi in laboratorijske nepravilnosti nadzorovane in se splošno stanje bolnika očitno izboljša, se lahko zdravljenje z ipilimumabom nadaljuje, odmerek kortikosteroida pa se lahko na osnovi klinične presoje začne postopno zmanjševati.
English: Figure 5 Overall survival (CA209067) - Minimum follow-up of 36 months
Slovenian: Slika 5 Celokupno preživetje (študija CA209067) - najmanjše obdobje spremljanja 36 mesecev
English: To dilute the YERVOY concentrate, you can use either:
Slovenian: Za redčenje koncentrata zdravila YERVOY lahko uporabite:
English: Clinical and pharmacokinetic data with pre-existing severe renal impairment are limited; the potential need for dose adjustment cannot be determined.
Slovenian: Klinični in farmakokinetični podatki pri bolnikih s predhodno hudo okvaro ledvic so omejeni, zato morebitne potrebe po prilagoditvi odmerka ni mogoče ugotoviti.
English: The Marketing Authorisation Holder shall agree the format and content of the above material with the National Competent Authority prior to launch in the Member State.
Slovenian: Pred prihodom zdravila na trg v vsaki državi članici, se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede oblike in vsebine zgoraj navedenih gradiv.
English: In peripheral blood of patients with melanoma, a mean increase in the percent of activated HLA-DR+ CD4+ and CD8+ T cells was observed after treatment with ipilimumab, consistent with its mechanism of action.
Slovenian: Po zdravljenju z ipilimumabom so v periferni krvi bolnikov z melanomom opazili povečanje povprečnega odstotka aktiviranih HLA-DR+ CD4+ in CD8+ T celic, kar se sklada z njegovim mehanizmom delovanja.
English: For patients with moderate (Grade 2) neuropathy (motor with or without sensory) likely related to ipilimumab, the scheduled dose should be withheld.
Slovenian: Pri bolnikih z zmerno (stopnja 2) nevropatijo (motorična s senzorično ali brez), ki bi lahko bila povezana z ipilimumabom, je treba naslednji predvideni odmerek zdravila zadržati.
English: Ipilimumab in combination with nivolumab is used to treat advanced melanoma (a type of skin cancer) in adults advanced renal cell carcinoma (advanced kidney cancer) in adults
Slovenian: Ipilimumab v kombinaciji z nivolumabom uporabljamo za zdravljenje: napredovalega melanoma (vrsta kožnega raka) pri odraslih napredovalega karcinoma ledvičnih celic (napredovalega raka ledvic) pri odraslih
English: Patients with ocular/uveal melanoma were excluded from clinical trials of melanoma.
Slovenian: Bolnike z očesnim/uvealnim melanomom so izključili iz kliničnih preskušanj pri melanomu.
English: Ipilimumab with nivolumab was continued beyond progression in 29% of patients.
Slovenian: Po napredovanju bolezni se je zdravljenje z ipilimumabom v kombinaciji z nivolumabom nadaljevalo pri 29 % bolnikov.
English: Based on population pharmacokinetic analysis, the following mean (percent coefficient of variation) parameters of ipilimumab were obtained: terminal half-life of 15.4 days (34.4%); systemic CL of 16.8 ml/h (38.1%); and volume of distribution at steady-state of 7.47 l (10.1%).
Slovenian: Na osnovi analize populacijske farmakokinetike so bili ugotovljeni naslednji povprečni (odstotek koeficienta variacije) parametri ipilimumaba: končni razpolovni čas 15,4 dni (34,4 %), sistemski očistek 16,8 ml/uro (38,1 %) in volumen porazdelitve v stanju dinamičnega ravnovesja 7,47 litra (10,1 %).
English: Neurologic: New onset or worsening severe motor or sensory neuropathy
Slovenian: Živčevje: nov pojav ali poslabšanje hude motorične ali senzorične nevropatije motorična ali senzorična nevropatija stopnje 3 ali 4
English: Median and estimated rates of OS at 1 year and 2 years are presented in Table 8.
Slovenian: Mediana vrednost in ocenjeni deleži celokupnega preživetja po 1 letu in 2 letih so prikazani v preglednici 8.
English: Permanent discontinuation of treatment was required in a greater proportion of patients receiving ipilimumab in combination with nivolumab than in those receiving nivolumab monotherapy.
Slovenian: Zdravljenje je bilo treba trajno ukiniti pri večjem deležu bolnikov, ki so se zdravili z ipilimumabom v kombinaciji z nivolumabom, kot pri bolnikih, ki so se zdravili z nivolumabom v monoterapiji.
English: CA184070
Slovenian: Študija CA184070
English: Signs and symptoms of severe skin reaction may include such as skin rash with or without itching, peeling of the skin, dry skin, fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells) and effects on liver, kidneys or lungs.
Slovenian: Znaki in simptomi hude kožne reakcije lahko vključujejo kožni izpuščaj s srbenjem ali brez, luščenje kože, suho kožo, zvišano telesno temperaturo, utrujenost, oteklino obraza ali bezgavk, zvišanje števila eozinofilcev (vrsta belih krvnih celic) in učinke na jetra, ledvice ali pljuča.
English: • Reminder to distribute the Patient Information Brochure, and to educate patients/caregivers about symptoms of irARs and of the need to report them immediately to the physician.
Slovenian: • Opomnik, da je treba bolnikom posredovati vodnik z informacijami za bolnike, ter da je treba bolnike in/ali njihove skrbnike seznaniti s simptomi imunsko pogojenih neželenih učinkov in jim pojasniti pomembnost takojšnjega obveščanja zdravnika, če se ti neželeni učinki pojavijo.
English: The median age was 61 years (range: 21-85) with 38% ≥ 65 years of age and 8% ≥ 75 years of age.
Slovenian: Mediana starost bolnikov je bila 61 let (razpon: 21-85), 38 % bolnikov je bilo starih ≥ 65 let, 8 % bolnikov pa ≥ 75 let.
English: The maximum tolerated dose of ipilimumab has not been determined.
Slovenian: Največji še prenosljivi odmerek ipilimumaba ni bil ugotovljen.
English: STEP 1 Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes.
Slovenian: KORAK Ustrezno število vial z zdravilom YERVOY pustite približno 5 minut na sobni temperaturi.
English: ** ipilimumab in combination with nivolumab for the first 4 doses then followed by nivolumab monotherapy in RCC.
Slovenian: ** ipilimumab v kombinaciji z nivolumabom za prve 4 odmerke in nato nivolumab v monoterapiji pri zdravljenju RCC.
English: Ipilimumab CL increased with increasing body weight and with increasing LDH at baseline; however, no dose adjustment is required for elevated LDH or body weight after administration on a mg/kg basis.
Slovenian: Očistek ipilimumaba se je povečeval z naraščanjem telesne mase in naraščanjem vrednosti LDH v izhodišču, vendar pa odmerka glede na zvišane vrednosti LDH ali večjo telesno maso glede na uporabo zdravila na osnovi mg/kg ni treba prilagajati.
English: Rare (may affect up to 1 in 1000 people) severe and possibly fatal peeling of the skin (toxic epidermal necrolysis) loosening of membrane at the back of the eye (serous retinal detachment)
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) hudo luščenje kože, ki se lahko konča tudi s smrtjo (toksična epidermalna nekroliza) odstopanje membrane na zadnji strani očesa (serozni odstop mrežnice)
English: The median duration of time from initial diagnosis to randomisation was 0.4 years in both the ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg and sunitinib groups.
Slovenian: Mediana trajanja časa od začetne diagnoze do randomizacije je bila 0,4 leta v obeh skupinah, v skupini z ipilimumabom v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg in v skupini s sunitinibom.
English: Based on the simulation in adults and paediatrics, comparable exposure is achieved in adults and paediatrics at the recommended dose of 3 mg/kg every 3 weeks.
Slovenian: Na osnovi simulacije je pri uporabi priporočenega odmerka 3 mg/kg na vsake 3 tedne pri odraslih in pediatričnih bolnikih dosežena primerljiva izpostavljenost.
English: Patients with mild or moderate infusion reaction may receive ipilimumab or ipilimumab in combination with nivolumab with close monitoring and use of premedication according to local treatment guidelines for prophylaxis of infusion reactions.
Slovenian: Bolniki z blago ali zmerno infuzijsko reakcijo se lahko zdravijo z ipilimumabom ali ipilimumabom v kombinaciji z nivolumabom, vendar pa jih je med infundiranjem treba skrbno nadzirati, za preprečevanje infuzijskih reakcij pa uporabiti premedikacijo v skladu z lokalnimi smernicami.
English: Both nivolumab-containing arms demonstrated greater objective response rates than ipilimumab regardless of PD-L1 expression levels.
Slovenian: Obe skupini zdravljenja z nivolumabom sta pokazali večji delež celokupnega odziva v primerjavi z ipilimumabom ne glede na nivo ekspresije PD-L1.
English: When administered in combination with nivolumab, the CL of ipilimumab increased by 5.7% in the presence of anti-ipilimumab antibodies and the CL of nivolumab increased by 20% in the presence of presence of anti-nivolumab antibodies.
Slovenian: Pri uporabi v kombinaciji z nivolumabom se je očistek ipilimumaba v prisotnosti protiteles proti ipilimumabu povečal za 5,7 %, očistek nivolumaba pa se je v prisotnosti protiteles proti nivolumabu povečal za 20 %.
English: When administered in combination with nivolumab, the CL of ipilimumab was unchanged in the presence of anti-ipilimumab antibodies and there was no evidence of altered toxicity profile.
Slovenian: Pri sočasni uporabi z nivolumabom je očistek ipilimumaba v prisotnosti protiteles proti ipilimumabu ostal nespremenjen, prav tako pa tudi niso ugotovili sprememb profila toksičnosti.
English: Rare proctitisd
Slovenian: Redki proktitisd
English: Patients with a history of autoimmune disease (other than vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism), including those who require systemic immunosuppressive therapy for pre-existing active autoimmune disease or for organ transplantation graft maintenance, were not evaluated in clinical trials.
Slovenian: Bolniki s predhodno avtoimunsko boleznijo (razen vitiliga in ustrezno nadzorovanega endokrinega primanjkljaja, kot je hipotiroidizem), vključno z bolniki, ki zaradi že obstoječih avtoimunskih bolezni ali po presaditvi organa potrebujejo sistemsko zdravljenje z imunosupresivnimi zdravili, v kliničnih preskušanjih niso bili ovrednoteni.
English: For patients with a severe (Grade 3) rash, the scheduled dose of ipilimumab should be withheld.
Slovenian: Pri bolnikih s hudim izpuščajem (stopnja 3) je treba naslednji predvideni odmerek ipilimumaba zadržati.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting ipilimumab to treat immune-related adverse reactions.
Slovenian: Sistemske kortikosteroide in druga imunosupresivna zdravila pa se lahko uporablja po začetku zdravljenja z ipilimumabom za zdravljenje imunsko pogojenih neželenih učinkov.
English: In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with YERVOY (see Tables 3A, 3B, and section 4.4).
Slovenian: Poleg tega je med zdravljenjem z zdravilom YERVOY treba ovrednotiti kateri koli znak ali simptom imunsko pogojenih neželenih učinkov, vključno z drisko in s kolitisom (glejte preglednici 3A in 3B ter poglavje 4.4).
English: Table 6: Immune-related adverse reactions leading to permanent discontinuation or requiring high-dose corticosteroids by dosing regimen
Slovenian: Preglednica 6: Imunsko pogojeni neželeni učinki, ki vodijo do trajne ukinitve zdravljenja ali zahtevajo zdravljenje z velikimi odmerki kortikosteroidov
English: Table 13:
Slovenian: Preglednica 13:
English: You may notice the appearance of new lesions or growth of existing lesions on your skin, which can be expected when you are being treated with YERVOY.
Slovenian: Med zdravljenjem z zdravilom YERVOY se lahko pojavijo nove ali razrastejo že prisotne spremembe na koži, kar pa je pri zdravljenju z zdravilom YERVOY pričakovano.
English: None of the events were fatal.
Slovenian: Nobeden od neželenih učinkov se ni končal s smrtnim izidom.
English: In patients receiving ipilimumab at a higher than recommended dose in combination with dacarbazine, immune-related hepatotoxicity occurred more frequently than in patients receiving ipilimumab 3 mg/kg monotherapy.
Slovenian: Pri bolnikih, ki so ipilimumab prejemali v odmerku, večjem od priporočenega, v kombinaciji z dakarbazinom, so se imunsko pogojeni toksični učinki za jetra pojavili pogosteje kot pri bolnikih, ki so ipilimumab prejemali v odmerku 3 mg/kg v obliki monoterapije.
English: Study CA184178 was a non-randomized, multicenter, open-label Phase 2 study, in adolescent patients 12 to < 18 years of age with previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma.
Slovenian: Študija CA184178 je bila nerandomizirana, multicentrična, odprta študija 2. faze, izvedena pri mladostnikih, starih od 12 do < 18 let, s predhodno zdravljenim ali nezdravljenim, neoperabilnim malignim melanomom v stadiju III ali stadiju IV. Bolniki so ipilimumab prejemali vsake 3 tedne 4 odmerke.
English: 10 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium).
Slovenian: 10 ml koncentrata v viali (steklo tipa I) z zamaškom (obložena butilna guma) in dvižno zaporko (aluminij).
English: In a Phase 2 trial, the sequential treatment with vemurafenib followed by 10 mg/kg ipilimumab in patients with BRAF-mutated metastatic melanoma showed a higher incidence of Grade 3+ skin adverse reactions than with ipilimumab alone.
Slovenian: V preskušanju 2. faze so pri zaporednem zdravljenju z vemurafenibom, ki mu je sledil ipilimumab v odmerku 10 mg/kg, pri bolnikih z metastatskim melanomom z mutacijo BRAF, ugotovili večjo pojavnost neželenih učinkov na kožo stopnje 3+ kot pri uporabi ipilimumaba samega.
English: Life threatening skin rash (including Stevens-Johnson syndrome or toxic epidermal necrolysis) or severe widespread pruritus interfering with activities of daily living or requiring medical intervention
Slovenian: življenjsko ogrožujoči kožni izpuščaj (vključno s Stevens-Johnsonovim sindromom ali toksično epidermalno nekrolizo) ali močno, razširjeno srbenje, ki vpliva na vsakodnevne aktivnosti ali zahteva zdravniško ukrepanje kožni izpuščaj stopnje 4 ali srbenje stopnje 3
English: A mean increase in the percent of central memory (CCR7+ CD45RA-) CD4+ and CD8+ T cells and a smaller, but significant, mean increase in the percent of effector memory (CCR7- CD45RA-) CD8+ T cells also was observed after treatment with ipilimumab.
Slovenian: Po zdravljenju z ipilimumabom so opazili tudi povečanje povprečnega odstotka centralnih spominskih (CCR7+ CD45RA-) CD4+ in CD8+ T celic in manjše, vendar pomembno povečanje povprečnega odstotka efektorskih spominskih (CCR7- CD45RA-) CD8+ T celic.
English: The management guidelines for these adverse reactions are described in section 4.4.
Slovenian: Smernice za ukrepanje v primeru pojava teh neželenih učinkov so opisane v poglavju 4.4.
English: The overall safety profile of ipilimumab 3 mg/kg in clinical trial CA184-169 (N=362) was consistent with that established for ipilimumb in patients treated for advanced melanoma.
Slovenian: Celoten varnostni profil ipilimumaba v odmerku 3 mg/kg je bil v kliničnem preskušanju CA184-169 (N=362) skladen z varnostnim profilom ipilimumaba pri bolnikih, ki so se zdravili zaradi napredovalega melanoma.
English: A total of 676 patients were randomized: 137 to the ipilimumab monotherapy group, 403 to the ipilimumab + gp100 group, and 136 to the gp100 alone group.
Slovenian: V celoti je bilo randomiziranih 676 bolnikov: 137 bolnikov v skupino, ki je prejemala samo ipilimumab, 403 bolniki v skupino, ki je prejemala ipilimumab + gp100 in 136 bolnikov v skupino, ki je prejemala samo gp100.
English: Patients must be treated according to institutional guidelines for management of sensory neuropathy, and intravenous corticosteroids (e.g. methylprednisolone 2 mg/kg/day) should be initiated immediately.
Slovenian: Bolnike je treba zdraviti v skladu z veljavnimi smernicami za zdravljenje senzorične nevropatije in nemudoma uvesti zdravljenje z intravenskimi kortikosteroidi (npr. metilprednizolon 2 mg/kg/dan).
English: 40 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium).
Slovenian: 40 ml koncentrata v viali (steklo tipa I) z zamaškom (obložena butilna guma) in dvižno zaporko (aluminij).
English: Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Slovenian: Podrobne smernice za ukrepanje v primeru pojava imunsko pogojenih neželenih učinkov so opisane v poglavju 4.4.
English: Clinical and pharmacokinetic data with pre-existing moderate hepatic impairment are limited; the potential need for dose adjustment cannot be determined.
Slovenian: Klinični in farmakokinetični podatki pri bolnikih s predhodno zmerno okvaro jeter so omejeni, zato morebitne potrebe po prilagoditvi odmerka ni mogoče ugotoviti.