natgillin/translations-raw huggingface dataset:
Other side effects that have been reported (frequency not known) include:  a type of skin blistering disease (called pemphigoid)  a condition where the immune system makes too many infection-fighting cells called histiocytes and lymphocytes that may cause various symptoms (called histiocytosis haematophagic)
Drugi neželeni učinki, o katerih so poročali (njihova pogostnost ni znana), so:  vrsta kožne bolezni s pojavom mehurčkov na koži (imenovana pemfigoid) stanje, pri katerem imunski sistem tvori preveč celic, ki se borijo proti okužbam, imenovanih histiociti in limfociti, kar lahko povzroči različne simptome (stanje imenujemo hematofagna histiocitoza)
Patients received ipilimumab every 3 weeks for 4 doses as tolerated (induction therapy).
Bolniki so glede na prenašanje prejeli 4 odmerke ipilimumaba na vsake 3 tedne (indukcijsko zdravljenje).
The use of systemic corticosteroids at baseline, before starting ipilimumab, should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of ipilimumab.
Uporabi sistemskih kortikosteroidov v izhodišču, pred začetkom zdravljenja z ipilimumabom, se je treba izogibati, saj lahko vplivajo na farmakodinamsko aktivnost in učinkovitost ipilimumaba.
Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes.
Ustrezno število vial z zdravilom YERVOY pustite približno 5 minut na sobni temperaturi.
If immunosuppression with corticosteroids is used to treat an adverse reaction that occurs as a consequence of combination therapy, a taper of at least 1 month duration should be initiated upon improvement.
Če se za zdravljenje neželenega učinka, ki se pojavi kot posledica kombiniranega zdravljenja, uporabi imunosupresivno zdravljenje s kortikosteroidi, je treba po izboljšanju uvesti vsaj 1 mesečno postopno zmanjševanje odmerka.
No controlled studies have been conducted to evaluate the pharmacokinetics of ipilimumab in the paediatric population or in patients with hepatic or renal impairment.
Nadzorovane študije, ki bi ovrednotile farmakokinetiko ipilimumaba pri pediatrični populaciji ali pri bolnikih z okvaro jeter ali ledvic, niso bile izvedene.
Do not drive, cycle or use machines after you have been given YERVOY unless you are sure you are feeling well.
Vpliv na sposobnost upravljanja vozil in strojev Po prejemu zdravila YERVOY ne smete voziti vozil, kolesariti ali upravljati strojev, če niste povsem prepričani, da se dobro počutite.
Increases in AST and ALT or total bilirubin should be evaluated to exclude other causes of hepatic injury, including infections, tumour progression, or concomitant medication and monitored until resolution.
Zvišanje vrednosti AST in ALT ali skupnega bilirubina je treba ovrednotiti, da se izključi druge možne vzroke poškodbe jeter, vključno z okužbami, napredovanjem tumorja ali sočasno uporabljenimi zdravili, in jih nadzirati do izboljšanja.
How to use YERVOY
Kako uporabljati zdravilo YERVOY
Very common decreased appetite decreased appetite
Presnovne in prehranske motnje Zelo pogosti zmanjšanje apetita zmanjšanje apetita
Secretion of IgGs in human milk is generally limited and IgGs have a low oral bioavailability.
Izločanje IgG v materino mleko je na splošno majhno, prav tako je majhna biološka uporabnost IgG po zaužitju.
Uncommon mental status changes, depression, decreased libido Nervous system disorders
Občasni spremembe duševnega stanja, depresija, zmanjšanje libida
The volume of YERVOY concentrate to prepare the dose (ml) = the total dose in mg, divided by 5 (the YERVOY concentrate strength is 5 mg/ml).
Volumen koncentrata zdravila YERVOY za pripravo odmerka (ml) = celotni odmerek v mg deljeno s 5 (jakost koncentrata zdravila YERVOY je 5 mg/ml).
Ipilimumab monotherapy or ipilimumab in combination with nivolumab: The prescribed dose for the patient is given in mg/kg.
Zdravljenje z ipilimumabom v monoterapiji ali v kombinaciji z nivolumabom: Predpisani odmerek za bolnika je podan v mg/kg.
The safety and efficacy of ipilimumab in children younger than 12 years of age has not been established.
Varnost in učinkovitost ipilimumaba pri otrocih, mlajših od 12 let, nista bili dokazani.
The frequency of severe (Grade 3 or 4) hypopituitarism was reported in 3% of patients.
O hudem (stopnja 3 ali 4) hipopituitarizmu so poročali pri 3 % bolnikov.
METHOD AND ROUTE(S) OF ADMINISTRATION IV use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA i.v.
If dosing is resumed after a delay, either the combination treatment or nivolumab monotherapy could be resumed based on the evaluation of the individual patient.
Če se po prekinitvi zdravljenje nadaljuje, je treba kombinirano zdravljenje ali zdravljenje z nivolumabom v monoterapiji nadaljevati na osnovi ocene pri posameznem bolniku.
Efficacy Results in CA184178 Ipilimumab 3 mg/kg N= 4
Rezultati učinkovitosti v študiji CA184178 ipilimumab 3 mg/kg N=4
Polyethersulfone (0.2 μm to 1.2 μm) and nylon (0.2 μm) in-line filters
s filtri iz polietersulfona (0,2 µm do 1,2 µm) in najlona (0,2 µm).
YERVOY in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Zdravilo YERVOY je v kombinaciji z nivolumabom indicirano za zdravljenje napredovalega (neoperabilnega ali metastatskega) melanoma pri odraslih bolnikih.
Any other adverse reactions that are demonstrated or suspected to be immune-related should be graded according to CTCAE.
Vse druge neželene učinke, ki so dokazano ali domnevno imunsko pogojeni, je treba ovrednotiti po kriterijih CTCAE.
Unless an alternate etiology has been identified, diarrhoea, increased stool frequency, bloody stool, LFT elevations, rash and endocrinopathy must be considered inflammatory and ipilimumab-related.
Če se ne ugotovi drugačne etiologije, je treba drisko, pogostejše odvajanje blata, krvavo blato, zvišane vrednosti testov delovanja jeter, kožni izpuščaj in endokrinopatije obravnavati kot vnetne in povezane z uporabo ipilimumaba.
Before initiating treatment with ipilimumab monotherapy in adolescents of 12 years and older, physicians are advised to carefully evaluate the individual patient, taking into consideration the limited available data, the observed benefits and the toxicity of ipilimumab monotherapy in the paediatric population (see sections 4.8 and 5.1).
Pred uvedbo zdravljenja z ipilimumabom v monoterapiji pri mladostnikih, starih 12 let in starejših, morajo zdravniki skrbno ovrednotiti posameznega bolnika, pri čemer morajo upoštevati omejenost razpoložljivih podatkov, opažene koristi in toksičnost ipilimumaba v monoterapiji pri pediatrični populaciji (glejte poglavji 4.8 in 5.1).
DRESS may be characterized by a long latency (two to eight weeks) between medicinal product exposure and disease onset.
DRESS lahko dolgo ostane prikrit in se pojavi šele dva do osem tednov po izpostavljenosti zdravilu.
In other patients with a history of autoimmune disease, ipilimumab should be used with caution after careful consideration of the potential risk-benefit on an individual basis.
Pri drugih bolnikih s predhodno avtoimunsko boleznijo pa je ipilimumab treba uporabljati previdno, po skrbni presoji možnih tveganj in koristi pri vsakem bolniku posebej.
Of the patients who were treated with ipilimumab in combination with nivolumab and evaluable for the presence of anti-ipilimumab antibodies, the incidence of anti-ipilimumab antibodies ranged from 6.3 to 8.4%%.
Pri bolnikih, ki so se zdravili z ipilimumabom v kombinaciji z nivolumabom, in so jih ovrednotili na prisotnost protiteles proti ipilimumabu, je pojavnost protiteles proti ipilimumabu znašala od 6,3 % do 8,4 %.
Tell your doctor immediately if you have any of these signs or symptoms or they get worse.
Če opazite katerega koli od teh znakov ali simptomov ali če znaki ali simptomi postajajo vse hujši, o tem nemudoma obvestite zdravnika.
No specific dose adjustment is necessary in this population (see section 5.1).
Pri tej skupini bolnikov odmerka ni treba posebej prilagajati (glejte poglavje 5.1).
OS results from this follow-up analysis are shown in Figure 5 (all randomised), Figure 6 (at the tumour PD-L1 1% cut off), and Table 10 (at the tumour PD-L1 5% cut off).
Rezultati celokupnega preživetja iz te analize spremljanja so prikazani na sliki 5 (vsi randomizirani bolniki), sliki 6 (pri mejni vrednosti PD-L1 tumorja 1 %) in v preglednici 10 (pri mejni vrednosti PD-L1 tumorja 5 %).
The pharmacokinetics of ipilimumab was studied in 785 patients with advanced melanoma who received induction doses ranging from 0.3 to 10 mg/kg administered once every 3 weeks for 4 doses.
Farmakokinetiko ipilimumaba so raziskovali pri 785 bolnikih z napredovalim melanomom, ki so prejeli indukcijske odmerke v razponu od 0,3 do 10 mg/kg enkrat na vsake 3 tedne, skupaj 4 odmerke.
If resolution has not occurred, continue to withhold doses until resolution then resume treatment.d
Če se stanje ne izboljša, zadržite aplikacijo odmerkov dokler se stanje ne izboljša, nato pa nadaljujte z zdravljenjem.d
80 NR (35.75, NR)
80 ND (35,75; ND)
Any other organ system adverse reactions that are considered immune-related should be graded according to CTCAE.
Vse neželene učinke na druge organske sisteme, ki se smatrajo za imunsko pogojene, je treba ovrednotiti po kriterijih CTCAE.
Frequencies are based on pooled data from 9 clinical trials investigating the ipilimumab 3 mg/kg dose in melanoma.
Pogostnost temelji na združenih podatkih iz 9 kliničnih preskušanj, ki so raziskovala uporabo ipilimumaba v odmerku 3 mg/kg pri bolnikih z melanomom.
Grade 4 or recurrent Grade 3 ; persistent Grade 2 or 3 despite treatment modification ; inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day
Stopnje 4 ali ponovitev stopnje 3, vztrajanje stopnje 2 ali 3 kljub prilagoditvi zdravljenja, nezmožnost zmanjšanja odmerka kortikosteroida na 10 mg prednizona ali njegovega ekvivalenta na dan
Withhold dose until an adverse reaction resolves to Grade 1 or Grade 0 (or returns to baseline).
Zadržite aplikacijo odmerka, dokler se neželeni učinek ne ublaži do stopnje 1 ali stopnje 0 (ali vzpostavi izhodiščno stanje).
Table 6 presents the percentage of patients with immune-related adverse reactions who were permanently discontinued from treatment with ipilimumab in combination with nivolumab.
V preglednici 6 so predstavljeni deleži bolnikov z imunsko pogojenimi neželenimi učinki, pri katerih je bilo zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukinjeno.
• Brief introduction to ipilimumab and the purpose of this risk minimisation tool.
• Kratka predstavitev ipilimumaba in namen tega vodnika.
It is very important for you to keep all your appointments to receive YERVOY.
Zelo pomembno je, da prejmete vse predvidene odmerke zdravila YERVOY.
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).
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).
- inflammation of the intestines (colitis) which can worsen to bleedings or bowel perforation.
- vnetje črevesa (kolitis), ki se lahko poslabša do pojava krvavitev ali predrtja črevesa.
In some cases, addition of other immunosuppressive therapy may be considered (see section 4.4).
Pri posameznih bolnikih bo morda potrebno še dodatno imunosupresivno zdravljenje (glejte poglavje 4.4).
Table 12: Efficacy results in intermediate/poor risk patients (CA209214)
Preglednica 12: Rezultati učinkovitosti pri bolnikih s srednje ugodnim ali slabim prognostičnim obetom (študija CA209214)
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.
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]).
Clinical trials excluded patients with ECOG performance status > 1 and mucosal melanoma.
Iz kliničnih preskušanj so bili izključeni bolniki s telesno zmogljivostjo po ECOG >1 in sluzničnim melanomom.
Neutralising antibodies against ipilimumab were not detected.
Nevtralizirajočih protiteles proti ipilimumabu niso ugotovili.
Recommended treatment modifications for YERVOY in combination with nivolumab or administration of the second phase of treatment (nivolumab monotherapy) following combination treatment
Priporočene prilagoditve zdravljenja z zdravilom YERVOY v kombinaciji z nivolumabom ali druge faze zdravljenja (nivolumab v monoterapiji) po kombiniranem zdravljenju
- - -*- - - - Nivolumab+ipilimumab (events: 161/314), median and 95% CI: 11.50 (8.90, 22.18).
- - -*- - - - nivolumab+ipilimumab (dogodki: 161/314), mediana in 95% IZ: 11,50 (8,90; 22,18).
In patients with melanoma who received ipilimumab, the mean peripheral blood absolute lymphocyte counts (ALC) increased throughout the induction dosing period.
Pri bolnikih z melanomom, ki so prejemali ipilimumab, se je povprečno absolutno število limfocitov v periferni krvi med indukcijskim zdravljenjem ves čas povečevalo.
When YERVOY is given following prior vemurafenib there may be an increased risk of skin side-effects.
Če boste prejeli zdravilo YERVOY po predhodnem zdravljenju z vemurafenibom, se lahko poveča tveganje za pojav neželenih učinkov na kožo.
Ipilimumab alone is used to treat advanced melanoma (a type of skin cancer) in adults and adolescents 12 years of age and older.
Ipilimumab samostojno uporabljamo za zdravljenje napredovalega melanoma (vrsta kožnega raka) pri odraslih in mladostnikih, starih 12 let in starejših.
- 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).
- vnetje mišic, kot so miokarditis (vnetje srčne mišice), miozitis (vnetje mišic) in rabdomioliza (okorelost mišic in sklepov, mišični krč).
Fatal toxic epidermal necrolysis (including SJS) has been reported in < 1% of patients who received ipilimumab in combination with gp100 (see section 5.1).
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).
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.
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.
Table 4: Adverse reactions in patients with advanced melanoma treated with ipilimumab 3 mg/kg (n= 767)a
Preglednica 4: Neželeni učinki pri bolnikih z napredovalim melanomom, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg (n= 767)a
- 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).
- 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).
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.
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.
A Phase 3, double-blind study enrolled patients with previously treated or untreated unresectable Stage III or Stage IV melanoma.
Dvojno slepa študija 3. faze je vključevala bolnike s predhodno zdravljenim ali nezdravljenim neoperabilnim melanomom stadija III ali stadija IV.
Upon improvement, ipilimumab may be resumed (see section 4.2).
Po izboljšanju se zdravljenje z ipilimumabom lahko nadaljuje (glejte poglavje 4.2).
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.
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.
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.
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.
Figure 5 Overall survival (CA209067) - Minimum follow-up of 36 months
Slika 5 Celokupno preživetje (študija CA209067) - najmanjše obdobje spremljanja 36 mesecev
To dilute the YERVOY concentrate, you can use either:
Za redčenje koncentrata zdravila YERVOY lahko uporabite:
Clinical and pharmacokinetic data with pre-existing severe renal impairment are limited; the potential need for dose adjustment cannot be determined.
Klinični in farmakokinetični podatki pri bolnikih s predhodno hudo okvaro ledvic so omejeni, zato morebitne potrebe po prilagoditvi odmerka ni mogoče ugotoviti.
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.
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.
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.
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.
For patients with moderate (Grade 2) neuropathy (motor with or without sensory) likely related to ipilimumab, the scheduled dose should be withheld.
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.
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
Ipilimumab v kombinaciji z nivolumabom uporabljamo za zdravljenje: napredovalega melanoma (vrsta kožnega raka) pri odraslih napredovalega karcinoma ledvičnih celic (napredovalega raka ledvic) pri odraslih
Patients with ocular/uveal melanoma were excluded from clinical trials of melanoma.
Bolnike z očesnim/uvealnim melanomom so izključili iz kliničnih preskušanj pri melanomu.
Ipilimumab with nivolumab was continued beyond progression in 29% of patients.
Po napredovanju bolezni se je zdravljenje z ipilimumabom v kombinaciji z nivolumabom nadaljevalo pri 29 % bolnikov.
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%).
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 %).
Neurologic: New onset or worsening severe motor or sensory neuropathy
Živčevje: nov pojav ali poslabšanje hude motorične ali senzorične nevropatije motorična ali senzorična nevropatija stopnje 3 ali 4
Median and estimated rates of OS at 1 year and 2 years are presented in Table 8.
Mediana vrednost in ocenjeni deleži celokupnega preživetja po 1 letu in 2 letih so prikazani v preglednici 8.
Permanent discontinuation of treatment was required in a greater proportion of patients receiving ipilimumab in combination with nivolumab than in those receiving nivolumab monotherapy.
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.
CA184070
Študija CA184070
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.
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.
• 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.
• 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.
The median age was 61 years (range: 21-85) with 38% ≥ 65 years of age and 8% ≥ 75 years of age.
Mediana starost bolnikov je bila 61 let (razpon: 21-85), 38 % bolnikov je bilo starih ≥ 65 let, 8 % bolnikov pa ≥ 75 let.
The maximum tolerated dose of ipilimumab has not been determined.
Največji še prenosljivi odmerek ipilimumaba ni bil ugotovljen.
STEP 1 Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes.
KORAK Ustrezno število vial z zdravilom YERVOY pustite približno 5 minut na sobni temperaturi.
** ipilimumab in combination with nivolumab for the first 4 doses then followed by nivolumab monotherapy in RCC.
** ipilimumab v kombinaciji z nivolumabom za prve 4 odmerke in nato nivolumab v monoterapiji pri zdravljenju RCC.
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.
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.
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)
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)