FrancophonIA/ELRC3.0 huggingface dataset:
English: Withhold dose(s) until symptoms resolve, radiographic abnormalities improve, and management with corticosteroids is complete
Slovenian: Aplikacijo odmerka (odmerkov) zadržite, dokler simptomi ne izzvenijo, se radiografsko ugotovljene nepravilnosti ne izboljšajo in zdravljenje s kortikosteroidi ni končano.
English: Transient vision loss has been reported in patients with ipilimumab-related ocular inflammations.
Slovenian: Pri bolnikih, ki so imeli z ipilimumabom povezana očesna vnetja, so poročali o prehodni izgubi vida.
English: Of patients evaluable for the presence of anti-nivolumab antibodies, the incidence of anti-nivolumab antibodies was 26% with nivolumab 3 mg/kg and ipilimumab 1 mg/kg every 3 weeks and 37.8% with nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks.
Slovenian: Pri bolnikih, ki so jih ovrednotili na prisotnost protiteles proti nivolumabu, je pojavnost protiteles proti nivolumabu znašala 26 % pri zdravljenju z nivolumabom v odmerku 3 mg/kg v kombinaciji z ipilimumabom v odmerku 1 mg/kg vsake 3 tedne in 37,8 % pri zdravljenju z nivolumabom v odmerku 1 mg/kg v kombinaciji z ipilimumabom v odmerku 3 mg/kg vsake 3 tedne.
English: Data outside the 9 completed clinical trials in melanoma were included in frequency determinations.
Slovenian: Za določitev pogostnosti so upoštevani tudi podatki pridobljeni izven obsega 9 dokončanih kliničnih preskušanj pri melanomu.
English: Very common increased AST, increased ALT, increased total bilirubin, increased alkaline phosphatase, increased lipase, increased amylase, increased creatinine, hyperglycaemiac, hypoglycaemia, lymphopaenia, leucopoenia, neutropaenia, thrombocytopaenia, anaemia, hypocalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia increased AST, increased ALT, increased total bilirubin, increased alkaline phosphatase, increased lipase, increased amylase, increased creatinine, hyperglycaemiac, hypoglycaemia, lymphopaenia, leucopoenia, neutropaeniac, thrombocytopaenia, anaemia, hypercalcaemia, hypocalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia
Slovenian: Preiskaveb Zelo pogosti zvišanje vrednosti AST, zvišanje vrednosti ALT, zvišanje vrednosti skupnega bilirubina, zvišanje vrednosti alkalne fosfataze, zvišanje vrednosti lipaze, zvišanje vrednosti amilaze, zvišanje vrednosti kreatinina, hiperglikemijac, hipoglikemija, limfopenija, levkopenija, nevtropenija, trombocitopenija, anemija, hipokalciemija, hiperkaliemija, hipokaliemija, hipomagneziemija, hiponatriemija zvišanje vrednosti AST, zvišanje vrednosti ALT, zvišanje vrednosti skupnega bilirubina, zvišanje vrednosti alkalne fosfataze, zvišanje vrednosti lipaze, zvišanje vrednosti amilaze, zvišanje vrednosti kreatinina, hiperglikemijac, hipoglikemija, limfopenija, levkopenija, nevtropenijac, trombocitopenija, anemija, hiperkalciemija, hipokalciemija, hiperkaliemija, hipokaliemija, hipomagneziemija, hiponatriemija
English: No clinically relevant pharmacokinetic drug-drug interaction was observed between ipilimumab and paclitaxel/carboplatin, dacarbazine or its metabolite, 5-aminoimidazole-4-carboxamide (AIC).
Slovenian: Med ipilimumabom in paklitakselom/karboplatinom, dakarbazinom ali njegovim presnovkom 5-aminoimidazol-4-karboksamidom (AIC) niso ugotovili klinično pomembnih farmakokinetičnih interakcij.
English: Based on the population pharmacokinetic results, no specific dose adjustment is necessary in patients with mild hepatic impairment (see section 5.2).
Slovenian: Na osnovi rezultatov populacijske farmakokinetike pri bolnikih z blago okvaro jeter odmerka ni treba posebej prilagajati (glejte poglavje 5.2).
English: If the patient has developed SJS or TEN with the use of ipilimumab in combination with nivolumab, permanent discontinuation of treatment is recommended (see section 4.2).
Slovenian: Če se med zdravljenjem z ipilimumabom v kombinaciji z nivolumabom pri bolniku pojavi SJS ali TEN, je zdravljenje priporočljivo trajno ukiniti (glejte poglavje 4.2).
English: Drug-related AEs, n (%)
Slovenian: Z zdravilom povezani neželeni učinki, n (%)
English: How to store YERVOY 6.
Slovenian: Shranjevanje zdravila YERVOY 6.
English: PFS rate at 12 months and 95% CI: 49% (44, 55) ──Δ─── Nivolumab (events: 183/316), median and 95% CI: 6.87 (4.34, 9.46).
Slovenian: Delež PFS v 12. mesecu in 95 % IZ: 49 % (44; 55) ──Δ─── nivolumab (dogodki: 183/316), mediana in 95% IZ: 6,87 (4,34; 9,46).
English: What YERVOY contains The active substance is ipilimumab.
Slovenian: Kaj vsebuje zdravilo YERVOY Učinkovina je ipilimumab.
English: Immune-related endocrinopathy
Slovenian: Imunsko pogojena endokrinopatija
English: Yervoy in combination with nivolumab: When ipilimumab 3 mg/kg was administered in combination with nivolumab 1 mg/kg, there was no effect of nivolumab on the CL of ipilimumab.
Slovenian: Zdravilo YERVOY v kombinaciji z nivolumabom: Pri uporabi ipilimumaba v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg, nivolumab ni vplival na očistek ipilimumaba.
English: Table 5: Adverse reactions with ipilimumab in combination with nivolumab Ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg*
Slovenian: Preglednica 5: Neželeni učinki pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom Ipilimumab v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg*
English: If initial symptoms improve to mild (Grade 1) or resolve, ipilimumab therapy may be resumed (see section 4.2).
Slovenian: Če se začetni simptomi omilijo do blagih (stopnja 1) ali povsem minejo, se zdravljenje z ipilimumabom lahko nadaljuje (glejte poglavje 4.2).
English: Uncommon diabetic ketoacidosisc, diabetes mellitusc diabetic ketoacidosisc, hypopituitarism Metabolism and nutrition disorders
Slovenian: Občasni diabetična ketoacidozac, diabetesc diabetična ketoacidozac, hipopituitarizem
English: When administered in combination, there was no effect of anti-ipilimumab antibodies on the CL of ipilimumab.
Slovenian: Pri kombinirani uporabi, protitelesa proti ipilimumabu niso vplivala na očistek ipilimumaba.
English: PFS rate at 12 months and 95% CI: 42% (36, 47) - - -- - - Ipilimumab (events: 245/315), median and 95% CI: 2.89 (2.79, 3.42).
Slovenian: Delež PFS v 12. mesecu in 95 % IZ: 42 % (36, 47) - - -- - - ipilimumab (dogodki: 245/315), mediana in 95% IZ: 2,89 (2,79; 3,42).
English: Number of Subjects at Risk Nivolumab + Ipilimumab
Slovenian: Število ogroženih oseb nivolumab + ipilimumab nivolumab ipilimumab
English: OS in favourable risk patients receiving nivolumab plus ipilimumab compared to sunitinib had a hazard ratio of 1.13 (95% CI: 0.64, 1.99; p = 0.6710).
Slovenian: Razmerje ogroženosti za celokupno preživetje pri bolnikih z ugodnim prognostičnim obetom, ki so prejemali nivolumab v kombinaciji z ipilimumabom, v primerjavi s sunitinibom je znašalo 1,13 (95 % IZ: 0,64; 1,99; p = 0,6710).
English: Ipilimumab as monotherapy
Slovenian: Ipilimumab v monoterapiji
English: (95% CI) Difference in ORR (95% CI)d p-valuee,f
Slovenian: Potrjen objektivni odziv (BICR) (95% IZ) Razlika v deležu objektivnega odziva (ORR) (95 % IZ)d p-vrednoste,f
English: Mild to moderate Immune-related adverse reactions
Slovenian: Blagi do zmerni imunsko pogojeni neželeni učinki
English: The recommended infusion period is 30 or 90 minutes, depending on the dose.
Slovenian: Aplicirati ga je treba v obliki 30-minutne ali 90-minutne intravenske infuzije, odvisno od odmerka.
English: Before treatment, your doctor will check your general health.
Slovenian: Zdravnik bo pred uvedbo zdravljenja preveril vaše splošno zdravstveno stanje, med zdravljenjem pa opravljal krvne preiskave.
English: YERVOY 5 mg/ml concentrate for solution for infusion ipilimumab
Slovenian: YERVOY 5 mg/ml koncentrat za raztopino za infundiranje ipilimumab
English: Elevations in LFTs during taper may be managed with an increase in the dose of corticosteroid and a slower taper.
Slovenian: V primeru zvišanja vrednosti jetrnih testov v času postopnega zmanjševanja odmerka se odmerek kortikosteroida lahko poveča in upočasni hitrost zmanjševanja odmerka.
English: Patients with ocular melanoma, primary CNS melanoma and active brain metastases were not included in the MDX010-20 trial (see section 5.1).
Slovenian: Bolniki z očesnim melanomom, s primarnim melanomom v osrednjem živčevju in z aktivnimi zasevki v možganih niso bili vključeni v preskušanje MDX010-20 (glejte poglavje 5.1).
English: Yervoy in combination with nivolumab: When ipilimumab 1 mg/kg was administered in combination with nivolumab 3 mg/kg, the CL of ipilimumab was decreased by 1.5% and the CL of nivolumab was increased by 1% which were not considered clinically relevant.
Slovenian: Zdravilo YERVOY v kombinaciji z nivolumabom: Pri uporabi ipilimumaba v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg se je očistek ipilimumaba zmanjšal za 1,5 %, očistek nivolumaba pa povečal za 1 %, kar pa ne velja za klinično pomembno.
English: Additionally, developmental external or visceral abnormalities were identified in the urogenital system of 2 infants exposed in utero to ipilimumab.
Slovenian: Pri dveh mladičih, ki sta bila ipilimumabu izpostavljena in utero, so dodatno poročali še o zunanjih ali visceralnih razvojnih nepravilnostih urogenitalnega sistema.
English: Ipilimumab must be permanently discontinued in patients with severe (Grade 3 or 4) motor neuropathy regardless of causality (see section 4.2).
Slovenian: Pri bolnikih s hudo motorično nevropatijo (stopnja 3 ali 4) je treba zdravljenje z ipilimumabom ukiniti ne glede na vzrok (glejte poglavje 4.2).
English: For mild to moderate rash or mild pruritus that persists for 1 to 2 weeks and does not improve with topical corticosteroids, oral corticosteroid therapy should be initiated (e.g. prednisone 1 mg/kg once daily or equivalent).
Slovenian: Pri blagem do zmernem izpuščaju ali blagem srbenju, ki vztraja od 1 do 2 tedna in se z uporabo topikalnih kortikosteroidov ne izboljša, je treba uvesti zdravljenje s peroralnimi kortikosteroidi (npr. prednizon v odmerku 1 mg/kg enkrat na dan ali ekvivalent).
English: With protocol-specified management guidelines, resolution occurred in most cases (87%), with a median time from onset to resolution of 5 weeks (range 0.6 to 29 weeks).
Slovenian: Po ukrepanju v skladu s smernicami, določenimi s protokolom, se je stanje pri večini bolnikov (87 %) izboljšalo, mediana vrednost časa od pojava do izboljšanja je bila 5 tednov (razpon 0,6 do 29 tednov).
English: Inspect the YERVOY concentrate for particulate matter or discoloration.
Slovenian: Koncentrat zdravila YERVOY preglejte glede prisotnosti trdnih delcev ali spremembe barve.
English: Rare erythema multiformed, psoriasisd, Drug Reaction with Eosinophilia and Systemic
Slovenian: Redki multiformni eritemd, psoriazad, reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)d
English: Ipilimumab should be avoided in patients with severe active autoimmune disease where further immune activation is potentially imminently life threatening.
Slovenian: Pri bolnikih s hudimi aktivnimi avtoimunskimi boleznimi, kjer bi nadaljnja imunska aktivacija lahko ogrozila življenje bolnika, se je uporabi ipilimumaba treba izogibati.
English: Table 7:
Slovenian: Slika 7:
English: - inflammation of the liver (hepatitis) that can lead to liver failure.
Slovenian: - vnetje jeter (hepatitis), ki lahko napreduje do odpovedi jeter.
English: Excipients: Tris hydrochloride, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Slovenian: Pomožne snovi: tris v obliki klorida, natrijev klorid, manitol (E421), pentetska kislina, polisorbat 80, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
English: Fatal Guillain-Barré syndrome has been reported in < 1% of patients who received ipilimumab 3 mg/kg in combination with gp100.
Slovenian: O pojavu usodnega Guillain-Barréjevega sindroma so poročali pri manj kot 1 % bolnikov, ki so prejemali ipilimumab v odmerku 3 mg/kg v kombinaciji z gp100.
English: Cardiac disorders Common tachycardia tachycardia
Slovenian: Srčne bolezni Pogosti tahikardija tahikardija
English: Thereafter, nivolumab will be given as an infusion over a period of 30 or 60 minutes, every 2 weeks or 4 weeks, depending on the dose you are receiving (single-agent phase).
Slovenian: V nadaljevanju zdravljenja (faza zdravljenja samo z enim zdravilom) boste prejemali nivolumab v infuziji, ki bo trajala 30 ali 60 minut, vsaka 2 tedna ali vsake 4 tedne, odvisno od odmerka, ki ga boste prejemali.
English: In intermediate/poor-risk patients, OS benefit was observed in the ipilimumab in combination with nivolumab arm vs. sunitinib regardless of tumour PD-L1 expression.
Slovenian: Pri bolnikih s srednje ugodnim ali slabim prognostičnim obetom so korist za celokupno preživetje v skupini z ipilimumabom v kombinaciji z nivolumabom v primerjavi s skupino s sunitinibom opazili ne glede na ekspresijo PD-L1 tumorja.
English: Median time to onset of these endocrinopathies was 1.9 months (range: 0.0-28.1).
Slovenian: Mediani čas do pojava teh endokrinopatij je znašal 1,9 meseca (razpon: 0,0-28,1).
English: Time to onset of moderate to very severe (Grade 2 to 4) immune-related endocrinopathy ranged from 7 to nearly 20 weeks from the start of treatment.
Slovenian: Zmerne ali hude (stopnje 2 do 4) imunsko pogojene endokrinopatije so se pojavile od 7 pa do skoraj 20 tednov po začetku zdravljenja.
English: Ipilimumab in combination with nivolumab is associated with immune-related adverse reactions.
Slovenian: Uporaba ipilimumaba v kombinaciji z nivolumabom je bila povezana s pojavom imunsko pogojenih neželenih učinkov.
English: Less than 2% of patients with advanced melanoma who received ipilimumab in Phase 2 and 3 clinical trials developed antibodies against ipilimumab.
Slovenian: Protitelesa proti ipilimumabu je razvilo manj kot 2 % bolnikov z napredovalim melanomom, ki so v kliničnih preskušanjih 2. in 3. faze prejemali ipilimumab.
English: Nivolumab+ipilimumab (events: 139/314), median and 95% CI: N.A. (38.18, N.A.) OS rate and 95% CI at 12 months: 73% (68, 78), 24 months: 64% (59, 69), and 36 months: 58% (52, 63) ──Δ─── Nivolumab (events: 158/316), median and 95% CI: 37.59 months (29.08, N.A.) OS rate and 95% CI at 12 months: 74% (69, 79), 24 months: 59% (53, 64), and 36 months: 52% (46, 57) Ipilimumab (events: 206/315), median and 95% CI: 19.94 months (16.85, 24.61) OS rate and 95% CI at 12 months: 67% (61, 72), 24 months: 45% (39, 50), and 36 months: 34% (29, 39)
Slovenian: Delež OS in 95 % IZ v 12. mesecu: 73 % (68, 78), 24. mesecu: 64 % (59, 69) in 36 mesecu: 58 % (52, 63) ──Δ─── nivolumab (dogodki: 158/316), mediana in 95 % IZ: 37,59 meseca (29,08; NP) Delež OS in 95 % IZ v 12. mesecu: 74 % (69, 79), 24. mesecu: 59 % (53, 64) in 36. mesecu: 52 % (46, 57) ipilimumab (dogodki: 206/315), mediana in 95 % IZ: 19,94 meseca (16,85; 24,61) Delež OS in 95 % IZ v 12. mesecu: 67 % (61, 72), 24. mesecu: 45 % (39, 50) in 36. mesecu: 34 % (29, 39)
English: Thereafter the recommended dose of nivolumab is 240 mg given every 2 weeks or 480 mg given every 4 weeks (single-agent phase).
Slovenian: Po tem je priporočeni odmerek 240 mg nivolumaba vsaka 2 tedna ali 480 mg vsake 4 tedne (faza zdravljenja samo z enim zdravilom).
English: Elevations in LFTs may develop in the absence of clinical symptoms.
Slovenian: Vrednosti testov delovanja jeter so lahko povišane brez sočasno klinično izraženih simptomov.
English: Management of these adverse reactions may also require systemic high-dose corticosteroid therapy if demonstrated or suspected to be immune-related (see section 4.4 for detailed management guidelines).
Slovenian: Če so ti neželeni učinki dokazano ali domnevno imunsko pogojeni, bo morda potrebno tudi zdravljenje z visokimi odmerki sistemskih kortikosteroidov (za podrobne smernice za ukrepanje glejte poglavje 4.4).
English: Uncommon vasculitis, angiopathyb, peripheral ischaemia, orthostatic hypotension Rare temporal arteritisd
Slovenian: Občasni vaskulitis, angiopatijab, periferna ishemija, ortostatska hipotenzija
English: The median time to onset of severe or fatal (Grade 3 to 5) immune-related gastrointestinal reactions was 8 weeks (range 5 to 13 weeks) from the start of treatment.
Slovenian: Mediani čas do pojava hudih ali smrtnih (stopnje 3 do 5) imunsko pogojenih neželenih učinkov na prebavila je bila 8 tednov (razpon od 5 do 13 tednov) od začetka zdravljenja.
English: Fatalities due to gastrointestinal perforation have been reported in clinical trials (see section 4.8).
Slovenian: V kliničnih preskušanjih so poročali o smrtnih primerih zaradi perforacije v prebavilih (glejte poglavje 4.8).
English: Your doctor will continue giving you YERVOY for a total of 4 doses, depending on your tolerance to the treatment.
Slovenian: Zdravnik bo zdravljenje z zdravilom YERVOY nadaljeval, dokler ne boste prejeli vseh 4 odmerkov, pri čemer pa bo upošteval tudi vaše prenašanje zdravljenja.
English: Neurological: Moderate (Grade 2)b unexplained motor neuropathy, muscle weakness, or sensory neuropathy (lasting more than 4 days)
Slovenian: Živčevje: zmerna (stopnja 2)b nepojasnjena motorična nevropatija,
English: YERVOY contains sodium
Slovenian: Zdravilo YERVOY vsebuje natrij.
English: Adverse reactions reported in patients with advanced melanoma who were treated with ipilimumab 3 mg/kg in clinical trials (n= 767) and from post-marketing surveillance are presented in Table 4.
Slovenian: Neželeni učinki, o katerih so poročali pri bolnikih z napredovalim melanomom, ki so se v kliničnih preskušanjih zdravili z ipilimumabom v odmerku 3 mg/kg (n= 767), ter neželeni učinki, o katerih so poročali po prihodu zdravila na trg, so prikazani v preglednici 4.
English: Uncommon gastrointestinal perforationb,c, large intestine perforationb,c, intestinal perforationb,c, peritonitisb, gastroenteritis, diverticulitis, pancreatitis, enterocolitis, gastric ulcer, large intestinal ulcer, stomatitis, oesophagitis, ileusd
Slovenian: Občasni perforacija v prebavilihb,c, perforacija debelega črevesab,c, perforacija črevesab,c, peritonitisb, gastroenteritis, divertikulitis, pankreatitis, enterokolitis, želodčna razjeda, razjeda debelega črevesa, stomatitis, ezofagitis, ileusd
English: Patients with ocular melanoma, active brain metastases and prior therapy with ipilimumab were not included in the paediatric trial CA184070 (see section 5.1).
Slovenian: Bolniki z očesnim melanomom, bolniki z aktivnimi zasevki v možganih in bolniki, ki so se predhodno zdravili z ipilimumabom, niso bili vključeni v pediatrično preskušanje CA184070 (glejte poglavje 5.1).
English: The median time to onset of moderate to severe or fatal (Grade 2 to 5) skin adverse reactions was 3 weeks from start of treatment (range 0.9 to 16 weeks).
Slovenian: Mediana vrednost časa do pojava zmernih do hudih ali usodnih (stopnje 2 do 5) neželenih učinkov na koži je bila 3 tedne od začetka zdravljenja (razpon od 0,9 do 16 tednov).
English: Patients with brain metastases in study CA184338 had a median OS of 6.3 months (95% CI: 3.2 - 12.0) and patients without brain metastases had a median OS of 17.7 months (95% CI: 13.6 - 12.1).
Slovenian: Mediana OS je v študiji CA184338 pri bolnikih z metastazami v možganih znašala 6,3 meseca (95% IZ: 3,2 - 12,0), pri bolniki brez metastaz v možganih pa 17,7 mesecev (95% IZ: 13,6 - 12,1).
English: The estimated geometric mean CL is 8.72 mL/h in adolescent patients aged ≥12 to <18 years.
Slovenian: Pri mladostnikih, starih ≥ 12 do < 18 let, je ocenjeni geometrijski srednji očistek znašal 8,72 ml/uro.
English: Do not use YERVOY after the expiry date which is stated on the label and carton after EXP.
Slovenian: Zdravila YERVOY ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Table 10: Summary of overall survival by PD-L1 expression: 5% cut off - CA209067 - Minimum follow-up of 36 months
Slovenian: Preglednica 10: Povzetek rezultatov celokupnega preživetja (OS) glede na ekspresijo PD-L1: mejna vrednost 5 % - študija CA209067 - najmanjše obdobje spremljanja 36 mesecev
English: Significant systemic exposure of the infant is not expected and no effects on the breast-fed newborn/infant are anticipated.
Slovenian: Pri dojenem novorojencu/otroku sicer ne pričakujemo pomembnejše sistemske izpostavljenosti ali kakršnihkoli učinkov.
English: OS at 1 year % (95% CI) OS at 2 years % (95% CI) OS at 3 years % (95% CI) OS at 4 years % (95% CI)
Slovenian: 10 mesecev celokupno preživetje po 1 letu % (95 % IZ) celokupno preživetje po 2 letih % (95 % IZ) celokupno preživetje po 3 letih % (95 % IZ) celokupno preživetje po 4 letih % (95 % IZ)
English: For patients with significant LFT elevations that are refractory to corticosteroid therapy, addition of an alternative immunosuppressive agent to the corticosteroid regimen may be considered.
Slovenian: Pri bolnikih z znatno zvišanimi vrednostmi jetrnih testov, ki se ne odzivajo na zdravljenje s kortikosteroidi, je treba razmisliti o dodatnem zdravljenju z drugim imunosupresivom, poleg zdravljenja s kortikosteroidom.
English: Recommended doses and infusion times for intravenous administration of ipilimumab in combination with nivolumab
Slovenian: Preglednica 2: Priporočeni odmerki in časi infundiranja pri intravenski aplikaciji ipilimumaba v kombinaciji z nivolumabom
English: Patients with brain metastases in study CA184332 had a median OS of 7 months (95% CI: 5.06 - 12.81) and patients without brain metastases had a median OS of 14.1 months (95% CI: 9.96-Not estimated).
Slovenian: Mediana OS je v študiji CA184332 pri bolnikih z metastazami v možganih znašala 7 mesecev (95% IZ: 5,06 - 12,81), pri bolniki brez metastaz v možganih pa 14,1 mesecev (95% IZ: 9,96-ni ocenjeno).
English: When YERVOY is given alone for the treatment of skin cancer, the recommended dose is 3 mg of ipilimumab per kilogram of your body weight.
Slovenian: Pri zdravljenju kožnega raka z zdravilom YERVOY samostojno je priporočeni odmerek 3 mg ipilimumaba na kilogram telesne mase.
English: Clinical trials with ipilimumab in combination with nivolumab Melanoma
Slovenian: Klinična preskušanja z ipilimumabom v kombinaciji z nivolumabom Melanom
English: The hazard ratio (HR) for comparison of OS between ipilimumab monotherapy and gp100 was 0.66 (95% CI: 0.51, 0.87; p = 0.0026).
Slovenian: Razmerje tveganja za primerjavo celokupnega preživetja med monoterapijo z ipilimumabom in gp100 je bilo 0,66 (95 % interval zaupanja: 0,51; 0,87; p = 0,0026).
English: Caution should be used when ipilimumab is administered following prior vemurafenib.
Slovenian: Pri uporabi ipilimumaba po predhodni uporabi vemurafeniba je potrebna previdnost.
English: Patients must be monitored for gastrointestinal signs and symptoms that may be indicative of immune-related colitis or gastrointestinal perforation.
Slovenian: Bolnike je treba nadzirati glede pojava znakov in simptomov v prebavilih, ki bi lahko kazali na pojav imunsko pogojenega kolitisa ali perforacije v prebavilih.
English: SAEs, drug-related, n (%) AEs leading to study drug discontinuation, n (%) Drug-related AEs leading to study drug discontinuation, n (%) irAEs, n (%)
Slovenian: Z zdravilom povezani neželeni učinki, zaradi katerih je bilo treba zdravljenje v študiji prekiniti, n (%)
English: Unopened vial
Slovenian: Neodprte viale
English: Ipilimumab specific management guidelines for immune-related adverse reactions are described below for use as monotherapy and in combination with nivolumab.
Slovenian: V nadaljevanju so opisane za ipilimumab specifične smernice za ukrepanje v primeru pojava imunsko pogojenih neželenih učinkov za zdravljenje v monoterapiji ali v kombinaciji z nivolumabom.
English: For patients with Grade 2 transaminase or total bilirubin elevation, the scheduled dose of ipilimumab should be withheld, and LFTs must be monitored until resolution.
Slovenian: Pri bolnikih z zvišanjem vrednosti aminotransferaz ali skupnega bilirubina stopnje 2 je treba predvideni odmerek ipilimumaba zadržati in nadzirati vrednosti jetrnih testov do izboljšanja.