FrancophonIA/ELRC3.0 huggingface dataset:
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.39 (0.28, 0.54) Nivolumab vs. Ipilimumab - hazard ratio: 0.65 (0.48, 0.88) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.60 (0.43, 0.84)
Croatian: Nivolumab+ipilimumab naspram ipilimumaba - omjer hazarda 0,39 (0,28, 0,54) Nivolumab naspram ipilimumaba - omjer hazarda 0,65 (0,48, 0,88) Nivolumab+ipilimumab naspram.nivolumaba -omjer hazarda: 0,60 (0,43, 0,84)
English: Hepatic:
Croatian: Jetra:
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of rash was 48.8% (267/547).
Croatian: U bolesnika s RCC-om liječenih ipilimumabom u dozi od 1 mg/kg u kombinaciji s nivolumabom u dozi od 3 mg/kg, incidencija osipa iznosila je 48,8% (267/547).
English: For Grade 2 or 3 serum creatinine elevation, ipilimumab in combination with nivolumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju povišenja razine kreatinina 2. ili 3. stupnja, potrebno je odgoditi primjenu ipilimumaba u kombinaciji s nivolumabom i uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 0,5 do 1 mg/kg/dan metilprednizolona.
English: Nivolumab+ipilimumab vs ipilimumab (primary analysis) - HR (95% CI): 0.55 (0.45, 0.69); p-value: <0.0001 Nivolumab vs ipilimumab (primary analysis) - HR (95% CI): 0.65 (0.53, 0.80); p-value: <0.0001
Croatian: Nivolumab naspram ipilimumaba (primarna analiza) - HR (95% CI): 0,65 (0,53, 0,80); p-vrijednost <0.0001 Nivolumab+ipilimumab naspram nivolumaba (opisna analiza) - HR (95% CI): 0.85 (0.68, 1,07)
English: - histiocytosis haematophagic.
Croatian: - hematofagna histiocitoza.
English: Patients with a baseline performance score ≥ 2, active brain metastases or autoimmune disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the clinical trials of ipilimumab in combination with nivolumab.
Croatian: U klinička ispitivanja ipilimumaba u kombinaciji s nivolumabom nisu bili uključeni bolesnici s početnim funkcionalnim statusom od ≥ 2, aktivnim metastazama u mozgu ili autoimunom bolešću, kao ni bolesnici koji su prije uključivanja u ispitivanje primali sistemske imunosupresive.
English: Median OS (months) (95% CI)
Croatian: Medijan OS (mjeseci) (95% CI)
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of diarrhoea or colitis was 28.2% (154/547).
Croatian: U bolesnika s RCC-om liječenih ipilimumabom u dozi od 1 mg/kg u kombinaciji s nivolumabom u dozi od 3 mg/kg, incidencija proljeva ili kolitisa iznosila je 28,2% (154/547).
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of thyroid disorders was 27.2% (149/547).
Croatian: U bolesnika s RCC-om liječenih ipilimumabom u dozi od 1 mg/kg u kombinaciji s nivolumabom u dozi od 3 mg/kg, incidencija poremećaja štitnjače iznosila je 27,2% (149/547).
English: In the ipilimumab 3 mg/kg monotherapy group, diarrhoea and colitis of any severity were reported in 27% and 8%, respectively.
Croatian: U skupini koja je primala monoterapiju ipilimumabom u dozi od 3 mg/kg, proljev i kolitis bez obzira na stupanj težine zabilježeni su u 27% odnosno 8% bolesnika.
English: Very common (may affect more than 1 in 10 people) underactive thyroid gland (which can cause tiredness or weight gain), overactive thyroid gland (which can cause rapid heart rate, sweating and weight loss) loss of appetite headache shortness of breath (dyspnoea) inflammation of the intestines (colitis), diarrhoea (watery, loose or soft stools), vomiting or feeling sick (nausea), stomach pain skin rash sometimes with blisters, itching pain in the muscles and bones (musculoskeletal pain), painful joints (arthralgia) feeling tired or weak, fever
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) smanjena aktivnost štitnjače (koja može izazvati umor ili povećanje tjelesne težine), pojačana aktivnost štitnjače (koja može uzrokovati ubrzan puls, znojenje i gubitak tjelesne težine) smanjen tek glavobolja nedostatak zraka (dispneja) upala crijeva (kolitis), proljev (vodenaste, rijetke ili meke stolice), povraćanje, mučnina (nauseja), bol u trbuhu kožni osip, ponekad s mjehurićima, svrbež bol u mišićima i kostima (mišićno-koštana bol), bol u zglobovima (artralgija) osjećaj umora ili slabosti, vrućica
English: Uncommon vasculitis, angiopathyb, peripheral ischaemia, orthostatic hypotension Rare temporal arteritisd
Croatian: Često hipotenzija, navale crvenila, navale vrućine Manje često vaskulitis, angiopatijab, periferna ishemija, ortostatska hipotenzija Rijetko temporalni arteritisd
English: In patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, time to onset of moderate to severe or fatal (Grade 2-5) immune-related hepatotoxicity ranged from 3 to 9 weeks from the start of treatment.
Croatian: U bolesnika koji su primali monoterapiju ipilimumabom u dozi od 3 mg/kg u MDX010-20, vrijeme od početka liječenja do nastupa umjerene do teške ili smrtonosne (2.-5. stupanj) imunološki uzrokovane hepatotoksičnosti iznosilo je od 3 do 9 tjedana.
English: Median time to onset was 1.2 months (range: 0.0-22.6).
Croatian: Medijan vremena do nastupa iznosio je 1,2 mjeseca (raspon: 0,0 - 22,6).
English: Withhold dose(s) until symptoms resolve and management with corticosteroids is completeb
Croatian: Odgoditi primjenu doze(a) dok se simptomi ne povuku i dok se ne dovrši liječenje kortikosteroidima
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of nephritis or renal dysfunction was 8.8% (48/547).
Croatian: U bolesnika s RCC-om liječenih ipilimumabom u dozi od 1 mg/kg u kombinaciji s nivolumabom u dozi od 3 mg/kg, incidencija nefritisa ili bubrežne disfunkcije iznosila je 8,8% (48/547).
English: Grade 2 adrenal insufficiency Grade 3 diabetes
Croatian: Insuficijencija nadbubrežne žlijezde 2. stupnja
English: Depending on your dose, some or all of the content of the YERVOY vial may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection before use.
Croatian: Ovisno o veličini doze, prije primjene razrijedit se će dio ili cijeli sadržaj bočice lijeka YERVOY u otopini natrijevog klorida za injekciju od 9 mg/ml (0,9%) ili otopini glukoze za injekciju od 50 mg/ml (5%).
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.42 (0.31, 0.55) Nivolumab vs. Ipilimumab - hazard ratio: 0.44 (0.34, 0.58) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.94 (0.69, 1.28)
Croatian: Nivolumab+ipilimumab naspram ipilimumaba - omjer hazarda: 0,42 (0,31, 0,55) Nivolumab naspram ipilimumaba -omjer hazarda 0.44 (0.34, 0.58) Nivolumab+ipilimumab naspram nivolumaba -omjer hazarda: 0,94 (0,69, 1,28)
English: mg/kg group experienced a Grade 1 and Grade 3 on-study endocrine irAR of hyperglycemia.
Croatian: Dva bolesnika u grupi liječenoj s 10 mg/kg, doživjela su u ispitivanju hipoglikemiju, koja je bila endokrini irAR 1. stupnja i 3.stupnja.
English: Fatal hepatic failure has been reported in < 1% of patients who received ipilimumab 3 mg/kg monotherapy.
Croatian: Zatajenje jetre sa smrtnim ishodom zabilježeno je u < 1% bolesnika koji su primali monoterapiju ipilimumabom u dozi od 3 mg/kg.
English: Each vial contains 200 mg ipilimumab.
Croatian: Jedna bočica sadrži 200 mg ipilimumaba.
English: How to use YERVOY 4.
Croatian: 3. Kako primjenjivati YERVOY
English: The improvement in OS was similar between ipilimumab with nivolumab and nivolumab monotherapy in patients with high tumour PD-L1 expression (PD-L1 ≥ 1%).
Croatian: Poboljšanje OS-a u bolesnika s visokom razinom tumorske ekspresije PD L1 (PD L1 ≥ 1%) bilo je slično uz nivolumab u kombinaciji s ipilimumabom i nivolumab u monoterapiji.
English: Common (may affect up to 1 in 10 people) tumour pain underactive function of the thyroid gland which can cause tiredness or weight gain, underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain dehydration confusion damage to the nerves (causing pain, weakness and cramps), dizziness, headache, blurred vision, pain in the eye low blood pressure, temporary redness of the face and neck, feeling of intense heat with sweating and rapid heart beat shortness of breath (dyspnoea), cough bleeding in the stomach or intestine, inflammation of the intestines (colitis), constipation, heartburn, stomach pain abnormal function of the liver inflammation of the inner surface lining of a particular organ inflammation and redness of the skin, skin colour change in patches (vitiligo), hives (itchy, bumpy rash), hair loss or thinning, excessive sweating at night, dry skin pain in muscles and joints(arthralgia), muscle spasms shivering, lack of energy, oedema (swelling), pain flu-like illness weight loss
Croatian: Često (mogu se javiti u do 1 na 10 osoba) tumorska bol smanjena aktivnost štitne žlijezde, što može prouzročiti umor i povećanje tjelesne težine,nedovoljna aktivnost (hipopituitarizam) ili upala (hipofizitis) hipofize, žlijezde koja se nalazi na bazi mozga, dehidracija smetenost oštećenje živaca (koje uzrokuje bol, slabost i grčeve), omaglica, glavobolja zamagljen vid, bol u očima snižen krvni tlak, prolazno crvenilo lica i vrata, osjećaj jake vrućine praćen znojenjem i ubrzanim lupanjem srca nedostatak zraka (dispneja), kašalj krvarenje u želudac ili crijeva, upala crijeva (kolitis), zatvor, žgaravica, bolovi u želucu poremećena funkcija jetre upala unutarnje površinske ovojnice određenog organa, upala i crvenilo kože, mjestimična promjena boje kože (vitiligo), koprivnjača (neravni osip sa svrbežom), ispadanje kose ili prorijeđena kosa, pojačano noćno znojenje, suha koža bolovi u mišićima i zglobovima (artralgija), mišićni grčevi drhtanje, nedostatak energije, edem (oticanje), bolovi simptomi nalik gripi gubitak na tjelesnoj težini
English: Ipilimumab must be permanently discontinued in patients with severe (Grade 3 or 4) diarrhoea or colitis (see section 4.2), and systemic high-dose intravenous corticosteroid therapy should be initiated immediately.
Croatian: U bolesnika s teškim (3. ili 4. stupanj) proljevom ili kolitisom (vidjeti dio 4.2) primjena ipilimumaba mora se trajno prekinuti i odmah započeti s intravenskom terapijom visokim dozama sistemskih kortikosteroida.
English: If applicable, dilute with the required volume of sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection.
Croatian: Ako je potrebno, razrijedite s potrebnim volumenom otopine natrijevog klorida za injekciju od 9 mg/ml (0,9%) ili otopine glukoze za injekciju od 50 mg/ml (5%).
English: The management guidelines for these adverse reactions are described in section 4.4.
Croatian: Terapijske smjernice za nuspojave opisane su u dijelu 4.4.
English: OS at 1 year % (95% CI) OS at 2 years % (95% CI)
Croatian: OS nakon 2 godine % (95%
English: Patients with ocular/uveal melanoma were excluded from clinical trials of melanoma.
Croatian: U klinička ispitivanja melanoma nisu bili uključeni bolesnici s očnim/uvealnim melanomom.
English: For Grade 3 or 4 transaminase or total bilirubin elevation, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju povišenja razine transaminaza ili ukupnog bilirubina 3. ili 4. stupnja, liječenje ipilimumabom u kombinaciji s nivolumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.59 (0.42, 0.82) Nivolumab vs. Ipilimumab - hazard ratio: 0.84 (0.61, 1.16) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.70 (0.49, 0.99)
Croatian: Nivolumab+Ipilimumab naspram ipilimumaba - omjer hazarda: 0,59 (0,42, 0,82) Nivolumab naspram ipilimumaba -omjer hazarda 0,84 (0,61, 1,16) Nivolumab+ipilimumab naspram nivolumaba - omjer hazarda: 0,70 (0.49, 0,99)
English: In patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, the median time to onset of moderate to severe or fatal (Grade 2-5) skin adverse reactions was 3 weeks (range 0.9-16 weeks) from start of treatment.
Croatian: U bolesnika koji su primali monoterapiju ipilimumabom u dozi od 3 mg/kg u ispitivanju MDX010-20, medijan vremena od početka liječenja do pojave umjerenih do teških ili smrtonosnih (2.-5. stupnja) kožnih nuspojava iznosio je 3 tjedna (raspon, 0,9-16 tjedana).
English: Severe hepatitis has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Croatian: Kod liječenja ipilimumabom u kombinaciji s nivolumabom primijećen je težak hepatitis (vidjeti dio 4.8).
English: Common (may affect up to 1 in 10 people) serious lung infection (pneumonia), infections of the upper respiratory tract, inflammation of the eye (conjunctivitis) increase of eosinophils (type of white blood cells) allergic reaction, reactions related to the infusion of the medicine decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes dehydration inflammation of the liver inflammation of the nerves (causing numbness, weakness, tingling or burning pain of the arms and legs), dizziness inflammation of the eye which causes redness or pain, blurred vision rapid heart beat high blood pressure (hypertension) inflammation of the lungs (pneumonitis, characterised by coughing and difficulty breathing), blood clots, fluid around the lungs, cough mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), constipation, dry mouth skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning, hives (itchy, bumpy rash)
Croatian: Često (mogu se javiti u do 1 na 10 osoba) ozbiljna plućna infekcija (pneumonija), infekcije gornjih dišnih putova, upala oka (konjunktivitis) povećan broj eozinofila (vrsta bijelih krvnih stanica) alergijska reakcija, reakcije povezane s infuzijom lijeka smanjeno lučenje hormona koje proizvode nadbubrežne žlijezde (žlijezde smještene iznad bubrega), nedovoljna aktivnost (hipopituitarizam) ili upala (hipofizitis) hipofize, žlijezde koja se nalazi na bazi mozga, oticanje štitnjače, šećerna bolest dehidracija upala jetre upala živaca (koja uzrokuje utrnulost, slabost, trnce ili žareću bol u rukama i nogama), omaglica upala oka koja uzrokuje bol i crvenilo, zamagljen vid ubrzani otkucaji srca visok krvni tlak (hipertenzija) upala pluća (pneumonitis, koji karakteriziraju kašalj i otežano disanje), krvni ugrušci, tekućina oko pluća, kašalj vrijedovi i afte u ustima (stomatitis), upala gušterače (pankreatitis), zatvor, suha usta mrljaste promjene boje kože (vitiligo), suha koža, crvenilo kože, neuobičajen gubitak ili stanjivanje kose, koprivnjača (osip koji svrbi) upala zglobova (artritis), mišićni grčevi, mišićna slabost zatajenje bubrega (uključujući nagli gubitak bubrežne funkcije) edem (oticanje), bol, bol u prsnom košu, zimica
English: Nivolumab+Ipilimumab (events: 63/155), median and 95% CI: N.A. (39.06, N.A.) ──Δ─── Nivolumab (events: 71/171), median and 95% CI: N.A. (40.21, N.A.) Ipilimumab (events: 103/164), median and 95% CI: 21.49 months (16.85, 29.08)
Croatian: ──Δ─── Nivolumab (događaji: 71/171), medijan i 95% CI: N.D. (40.21, N.D) Ipilimumab (događaji: 103/164), medijan i 95% CI: 21.49 mjeseci(16.85, 29,08)
English: When ipilimumab is administered in combination with nivolumab, refer to the Summary of Product Characteristics for nivolumab prior to initiation of treatment.
Croatian: Kada se ipilimumab.primjenjuje u kombinaciji s nivolumabom, prije početka liječenja potrebno je pročitati sažetak opisa svojstava lijeka za nivolumab.
English: Eye disorders Common blurred vision, eye pain
Croatian: Poremećaji oka Često zamagljen vid, bol u oku
English: Ipilimumab-induced rash and pruritus should be managed based on severity.
Croatian: Osip i svrbež izazvane ipilimumabom treba liječiti s obzirom na njihovu težinu.
English: Concurrent administration with vemurafenib
Croatian: Istovremena primjena sa vemurafenibom
English: The co-primary outcome measures were progression-free survival and OS. ORR and the duration of response were also assessed.
Croatian: Koprimarne mjere ishoda bile su preživljenje bez progresije bolesti i OS.
English: ≥ Grade 3 immune-related reactionsc
Croatian: ≥ imunološki uzrokovane nuspojave 3. stupnjac
English: For Grade 3 or 4 pneumonitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju pneumonitisa 3. ili 4. stupnja, liječenje ipilimumabom u kombinaciji s nivolumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 2 do 4 mg/kg/dan metilprednizolona.
English: Incidental cases of pemphigoid have been reported during post-marketing use.
Croatian: Uzgredni slučajevi pemfigoida zabilježeni su nakon stavljanja lijeka u promet.
English: For Grade 4 serum creatinine elevation, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju povišenja razine kreatinina 4. stupnja, liječenje ipilimumabom u kombinaciji s nivolumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: Ipilimumab is associated with serious immune-related neurological adverse reactions.
Croatian: Ipilimumab je povezan s ozbiljnim imunološki uzrokovanim nuspojavama živčanog sustava.
English: Nivolumab+ipilimumab vs nivolumab (descriptive analysis) - HR (95% CI): 0.85 (0.68, 1.07)
Croatian: Nivolumab+ipilimumab naspram ipilimumaba (primarna analiza) - HR (95% CI): 0.55 (0,45, 0,69); p-vrijednost:
English: PHARMACEUTICAL FORM AND CONTENTS Sterile concentrate
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ
English: Flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection at the end of the infusion.
Croatian: Na kraju infuzije isperite liniju otopinom natrijevog klorida za injekciju od 9 mg/ml (0,9%) ili otopinom glukoze za injekciju od 50 mg/ml (5%).
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of thyroid disorders was 25.2% (113/448).
Croatian: U bolesnika liječenih ipilimumabom u dozi od 3 mg/kg, u kombinaciji s nivolumabom u dozi od 1 mg/kg incidencija poremećaja štitnjače iznosila je 25,2% (113/448).
English: For symptomatic hypothyroidism, ipilimumab in combination with nivolumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Croatian: U slučaju simptomatske hipotireoze, liječenje ipilimumabom u kombinaciji s nivolumabom potrebno je odgoditi i po potrebi uvesti nadomjesnu terapiju.hormonima štitnjače.
English: For symptomatic diabetes, ipilimumab in combination with nivolumab should be withheld, and insulin replacement should be initiated as needed.
Croatian: U slučaju simptomatskog dijabetesa, potrebno je odgoditi primjenu ipilimumaba u kombinaciji s nivolumabom i po potrebi uvesti inzulinsku nadomjesnu terapiju.
English: Nivolumab+Ipilimumab (events: 59/123), median and 95% CI: N.A. (26.45, N.A.) ──Δ─── Nivolumab (events: 71/117), median and 95% CI: 23.46 months (13.01, 36.53) Ipilimumab (events: 77/113), median and 95% CI: 18.56 months (13.67, 23.20)
Croatian: ──Δ─── Nivolumab (događaji 71/117), medijan i 95% CI: 23,46 mjeseci (13,01, 36,53) Ipilimumab (događaji: 77/113), medijani 95% CI: 18,56 mjeseci (13,67, 23,20)
English: 25.9 (22.1, NE)
Croatian: 25,9 (22,1; NP)
English: sodium chloride 9 mg/ml (0.9%) solution for injection; or
Croatian: otopinu natrijevog klorida za injekciju od 9 mg/ml (0,9%); ili otopinu glukoze za injekciju od 50 mg/ml (5%)
English: Nivolumab+Ipilimumab (events: 77/155), median and 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (events: 86/171), median and 95% CI: 14.00 (7.03, N.A.) Ipilimumab (events: 129/164), median and 95% CI: 3.91 (2.83, 4.17)
Croatian: ──Δ─── Nivolumab (događaji 86/171), medijan i 95% CI: 14,00 (7,03, N.D) Ipilimumab (događaji 129/164), medijan i 95% CI: 3.91 (2,83, 4,17)
English: Severe nephritis and renal dysfunction have been observed with ipilimumab in combination with nivolumab (see section 4.8).
Croatian: Kod liječenja ipilimumabom u kombinaciji s nivolumabom primijećeni su težak nefritis i disfunkcija bubrega (vidjeti dio 4.8).
English: Uncommon diabetic ketoacidosisc, diabetes mellitusc diabetic ketoacidosisc, hypopituitarism Metabolism and nutrition disorders
Croatian: Manje često dijabetička ketoacidozac, dijabetes mellitusc dijabetička ketoacidozac, hipopituitarizam
English: For Grade 2 diarrhoea or colitis, ipilimumab in combination with nivolumab should be withheld.
Croatian: U slučaju proljeva ili kolitisa 2. stupnja, potrebno je odgoditi primjenu ipilimumaba u kombinaciji s nivolumabom.
English: No patients with pre-existing severe hepatic impairment were identified in clinical studies.
Croatian: U kliničkim ispitivanjima nisu sudjelovali bolesnici s postojećim teškim oštećenjem funkcije jetre.
English: No statistically significant difference in progression free survival (PFS) was observed between the 10 mg/kg and the 3 mg/kg groups.
Croatian: Nije zabilježena statistički značajna razlika u preživljenju bez progresije (engl.progression free survival -PFS) među skupinama 10 mg/kg i 3 mg/kg. (HR 0,89 s 95% CI od 0,76; 1,04 i log-rang test P-vrijednost = 0,1548).
English: No Grade 3-5 cases were reported.
Croatian: Nisu prijavljeni slučajevi 3. - 5. stupnja.
English: SAEs, n (%)
Croatian: Štetni događaji n (%)
English: Fatal hepatic failure has been reported in clinical trials (see section 4.8).
Croatian: U kliničkim je ispitivanjima zabilježeno zatajenje jetre sa smrtnim ishodom (vidjeti dio 4.8).
English: If mild to moderate symptoms recur or persist for 5-7 days, the scheduled dose of ipilimumab should be withheld and corticosteroid therapy (e.g. prednisone 1 mg/kg orally once daily or equivalent) should be initiated.
Croatian: potrebno je odgoditi primjenu planirane doze ipilimumaba i započeti s kortikosteroidnom terapijom (npr. prednizon 1 mg/kg kroz usta jedanput na dan ili ekvivalent).
English: For Grade 4 diarrhoea or colitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Croatian: U slučaju proljeva ili kolitisa 4. stupnja, liječenje ipilimumabom u kombinaciji s nivolumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
English: Gastrointestinal:
Croatian: Probavni sustav:
English: Monotherapy phase
Croatian: Dijabetes 3. stupnja
English: 90 minutes administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab 3 mg/kg as monotherapy every 2 weeks.
Croatian: Bolesnici u skupini liječenoj kombiniranom terapijom primali su nivolumab u dozi od 1 mg/kg primijenjenoj intravenski tijekom 60 minuta te ipilimumab u dozi od 3 mg/kg primijenjenoj intravenski tijekom 90 minuta svaka 3 tjedna kod prve 4 doze, nakon čega je uslijedila monoterapija nivolumabom u dozi od 3 mg/kg svaka 2 tjedna.
English: Each vial contains 50 mg ipilimumab.
Croatian: Jedna bočica sadrži 50 mg ipilimumaba.
English: Immune-related neurological reactions
Croatian: Imunološki uzrokovane nuspojave
English: Respiratory, thoracic and mediastinal disorders Common dyspnea, cough
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Često dispneja, kašalj