natgillin/translations-raw huggingface dataset:
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.
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.
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.
Na osnovi simulacije je pri uporabi priporočenega odmerka 3 mg/kg na vsake 3 tedne pri odraslih in pediatričnih bolnikih dosežena primerljiva izpostavljenost.
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.
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.
Both nivolumab-containing arms demonstrated greater objective response rates than ipilimumab regardless of PD-L1 expression levels.
Obe skupini zdravljenja z nivolumabom sta pokazali večji delež celokupnega odziva v primerjavi z ipilimumabom ne glede na nivo ekspresije PD-L1.
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.
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 %.
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.
Pri sočasni uporabi z nivolumabom je očistek ipilimumaba v prisotnosti protiteles proti ipilimumabu ostal nespremenjen, prav tako pa tudi niso ugotovili sprememb profila toksičnosti.
Rare proctitisd
Redki proktitisd
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.
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.
For patients with a severe (Grade 3) rash, the scheduled dose of ipilimumab should be withheld.
Pri bolnikih s hudim izpuščajem (stopnja 3) je treba naslednji predvideni odmerek ipilimumaba zadržati.
However, systemic corticosteroids or other immunosuppressants can be used after starting ipilimumab to treat immune-related adverse reactions.
Sistemske kortikosteroide in druga imunosupresivna zdravila pa se lahko uporablja po začetku zdravljenja z ipilimumabom za zdravljenje imunsko pogojenih neželenih učinkov.
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).
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).
Table 6: Immune-related adverse reactions leading to permanent discontinuation or requiring high-dose corticosteroids by dosing regimen
Preglednica 6: Imunsko pogojeni neželeni učinki, ki vodijo do trajne ukinitve zdravljenja ali zahtevajo zdravljenje z velikimi odmerki kortikosteroidov
Table 13:
Preglednica 13:
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.
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.
None of the events were fatal.
Nobeden od neželenih učinkov se ni končal s smrtnim izidom.
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.
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.
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.
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.
10 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium).
10 ml koncentrata v viali (steklo tipa I) z zamaškom (obložena butilna guma) in dvižno zaporko (aluminij).
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.
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.
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
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
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.
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.
The management guidelines for these adverse reactions are described in section 4.4.
Smernice za ukrepanje v primeru pojava teh neželenih učinkov so opisane v poglavju 4.4.
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.
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.
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.
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.
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.
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).
40 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium).
40 ml koncentrata v viali (steklo tipa I) z zamaškom (obložena butilna guma) in dvižno zaporko (aluminij).
Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Podrobne smernice za ukrepanje v primeru pojava imunsko pogojenih neželenih učinkov so opisane v poglavju 4.4.
Clinical and pharmacokinetic data with pre-existing moderate hepatic impairment are limited; the potential need for dose adjustment cannot be determined.
Klinični in farmakokinetični podatki pri bolnikih s predhodno zmerno okvaro jeter so omejeni, zato morebitne potrebe po prilagoditvi odmerka ni mogoče ugotoviti.
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).
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).
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).
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).
When administered in combination with nivolumab, nivolumab should be given first followed by YERVOY on the same day.
Pri uporabi zdravila v kombinaciji z nivolumabom je treba najprej aplicirati nivolumab, nato pa sledi še aplikacija zdravila YERVOY na isti dan.
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).
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).
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.
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.
Immune-related endocrinopathy observed in clinical trials was generally controlled with hormone replacement therapy.
Imunsko pogojene endokrinopatije, opažene v kliničnih preskušanjih, so se običajno dobro odzvale na hormonsko nadomestno zdravljenje.
Signs and symptoms may include redness in the eye, pain in the eye, vision problems, blurry vision or temporary loss of sight.
Znaki in simptomi lahko vključujejo rdečino oči, bolečino v očesu, težave z vidom, zamegljen vid ali začasno izgubo vida.
The safety and efficacy of YERVOY in children younger than 12 years of age have not been established.
Varnost in učinkovitost zdravila YERVOY pri otrocih, mlajših od 12 let, nista bili dokazani.
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.
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.
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).
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).
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
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
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,
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.
Life-threatening cases have been reported in completed or ongoing clinical studies.
V končanih študijah ali študijah, ki še potekajo, so poročali o življenjsko ogrožujočih primerih.
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.
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).
Administer the YERVOY infusion intravenously over a period of 30 or 90 minutes, depending on the dose.
YERVOY raztopino za infundiranje morate aplicirati v obliki 30-minutne ali 90-minutne intravenske infuzije, odvisno od odmerka.
Patients must be evaluated for evidence of gastrointestinal perforation or peritonitis.
Bolnike je treba ovrednotiti glede znakov perforacije v prebavilih ali peritonitisa.
Randomised phase 2 study of ipilimumab in combination with nivolumab and ipilimumab (CA209069)
Randomizirana študija 2. faze za ovrednotenje ipilimumaba v kombinaciji z nivolumabom in ipilimumaba (študija CA209069)
In most reported cases prior or concurrent therapy with a PD-1 or PD-L1 inhibitor has occurred.
V večini sporočenih primerov je šlo za predhodno ali sočasno zdravljenje z zaviralcem PD-1 ali PD-L1.
Children and adolescents YERVOY should not be used in children below 12 years of age.
Otroci in mladostniki Zdravila YERVOY se ne sme uporabljati pri otrocih, mlajših od 12 let.
No treatment-related adverse effects on reproduction were detected during the first two trimesters of pregnancy.
Med prvima dvema trimesečjema brejosti vplivov zdravila na sposobnost razmnoževanja niso zasledili.
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).
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).
Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
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.
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.
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.
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.
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.
Patients with a mild to moderate (Grade 1 or 2) rash may remain on ipilimumab therapy with symptomatic treatment (e.g. antihistamines).
Pri bolnikih z blagim do zmernim izpuščajem (stopnja 1 ali 2) se zdravljenje z ipilimumabom lahko nadaljuje ob sočasnem simptomatskem zdravljenju (npr. z antihistaminiki).
Figure 1: Overall Survival with ipilimumab 3 mg/kg in pooled analysis
Slika 1: Celokupno preživetje v analizi z ipilimumabom 3 mg/kg
Decision whether to discontinue YERVOY should be based on severity.
Odločitev o ukinitvi zdravljenja z zdravilom YERVOY je treba sprejeti na osnovi resnosti učinka.
Based on the severity of myotoxicity, ipilimumab in combination with nivolumab should be withheld or discontinued (see section 4.2), and appropriate treatment instituted.
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.
Vogt-Koyanagi-Harada syndromee, serous retinal detachment Cardiac disorders
Vogt-Koyanagi-Haradov sindrome, serozni odstop mrežnice
Once a diagnosis of myocarditis is established, ipilimumab in combination with nivolumab should be withheld or permanently discontinued (see section 4.2).
Če se diagnoza miokarditisa potrdi, je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati ali trajno ukiniti (glejte poglavje 4.2).
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).
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).
Severe symptoms (abdominal pain, severe diarrhoea or significant change in the number of stools, blood in stool, gastrointestinal haemorrhage, gastrointestinal perforation)
Prebavila: hudi simptomi (bolečine v trebuhu, huda driska ali pomembna sprememba v številu odvajanj blata, kri v blatu, krvavitev v prebavilih, perforacija v prebavilih)
From a microbiological point of view, once opened, the medicine should be infused or diluted and infused immediately.
Z mikrobiološkega stališča je treba zdravilo infundirati ali razredčiti in infundirati takoj po odprtju viale.
Ipilimumab in combination with nivolumab (see section 4.2)
Ipilimumab v kombinaciji z nivolumabom (glejte poglavje 4.2)
Each ml of concentrate contains 0.1 mmol sodium, which is 2.30 mg sodium.
En ml koncentrata vsebuje 0,1 mmol natrija, kar ustreza 2,30 mg natrija.
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.
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.
Unless otherwise specified, the data below reflect exposure to ipilimumab at 3 mg/kg in clinical trials of melanoma.
Če ni navedeno drugače, se podatki v nadaljevanju nanašajo na uporabo ipilimumaba v odmerku 3 mg/kg v kliničnih preskušanjih uporabe zdravila pri melanomu.
For patients who required re-treatment, the BORR was 38% (3/8 patients) in the ipilimumab monotherapy group, and 0% in the gp100 group.
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.
Evaluation of laboratory results to assess endocrine function may be performed before corticosteroid therapy is initiated.
Pred uvedbo zdravljenja s kortikosteroidi se lahko ovrednoti laboratorijske rezultate endokrine funkcije.
CA184004/007 Pooled
Združeni podatki študij CA184004/007
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).
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).
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.
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.
Common pneumonitisa,c, pulmonary embolisma, cough pneumonitis, dyspnoea, pleural effusion, cough
Pogosti pnevmonitisa,c, pljučna embolijaa, kašelj pnevmonitis, dispneja, plevralni izliv, kašelj
* ipilimumab in combination with nivolumab for the first 4 doses then followed by nivolumab monotherapy in melanoma.
* ipilimumab v kombinaciji z nivolumabom za prve 4 odmerke in nato nivolumab v monoterapiji pri zdravljenju melanoma.
In such patients, LFTs must be monitored until normalization.
Pri takšnih bolnikih je treba nadzirati vrednosti jetrnih testov do izboljšanja.
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.
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.
Based on these preliminary data, the concurrent administration of ipilimumab and vemurafenib is not recommended.
Na osnovi teh preliminarnih podatkov sočasna uporaba ipilimumaba in vemurafeniba ni priporočljiva.
Ipilimumab 3 mg/kg was administered to four patients and ipilimumab 10 mg/kg was administered to eight patients.
Ipilimumab v odmerku 3 mg/kg so prejemali štirje bolniki, ipilimumab v odmerku 10 mg/kg pa osem bolnikov.