FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited, but no long-term, safety data is available on the use of ipilimumab in adolescents 12 years of age and older.
Slovenian: Pri mladostnikih, starih 12 let in starejših, je na voljo malo podatkov o varnosti uporabe ipilimumaba, podatki o dolgoročni varnosti pa niso na voljo.
English: With appropriate medical therapy, immune-related adverse reactions resolved in most cases.
Slovenian: Imunsko pogojeni neželeni učinki so pri ustreznem zdravljenju v večini primerov izzveneli.
English: If you miss a dose of YERVOY
Slovenian: Če niste prejeli odmerka zdravila YERVOY
English: Guillain-Barré syndrome, polyneuropathy, neuritis, peroneal nerve palsy, autoimmune neuropathy (including facial and abducens nerve paresis), encephalitisc polyneuropathy, autoimmune neuropathy (including facial and abducens nerve paresis), myasthenia gravisc
Slovenian: Guillain Barréjev sindrom, polinevropatija, nevritis, pareza peronealnega živca, avtoimunska nevropatija (vključno s parezo obraznega in abducentnega živca), encefalitisc polinevropatija, avtoimunska nevropatija (vključno s parezo obraznega in abducentnega živca), miastenija gravisc
English: Decision whether to withhold a dose should be based on severity.
Slovenian: Odločitev o zadržanju odmerka zdravila YERVOY je treba sprejeti na osnovi resnosti učinka.
English: Patients without liver metastasis who had a baseline AST > 2.5 x ULN, patients with liver metastasis who had a baseline AST > 5 x ULN, and patients with a baseline total bilirubin ≥ 3 x ULN were also excluded.
Slovenian: Izključeni so bili tudi bolniki brez zasevkov v jetrih, ki so imeli izhodiščne vrednosti AST > 2,5 x ZNV, bolniki z zasevki v jetrih, ki so imeli izhodiščne vrednosti AST > 5 x ZNV in bolniki z izhodiščno vrednostjo skupnega bilirubina ≥ 3 x ZNV.
English: You must not use YERVOY if you are pregnant unless your doctor specifically recommends it.
Slovenian: Med nosečnostjo zdravila YERVOY ne smete uporabljati, razen na izrecno priporočilo zdravnika.
English: In MDX010-20 (see section 5.1), ipilimumab at 3 mg/kg with or without gp100 increased ALC throughout the induction dosing period, but no meaningful change in ALC was observed in the control group of patients who received an investigational gp100 peptide vaccine alone.
Slovenian: V študiji MDX010-20 (glejte poglavje 5.1) je bila uporaba ipilimumaba v odmerku 3 mg/kg, s sočasno uporabo gp100 ali brez, povezana s povečevanjem absolutnega števila limfocitov med indukcijskim obdobjem zdravljenja, pri bolnikih v kontrolni skupini, ki so prejemali preiskovano peptidno cepivo gp100 samo, pa pomembnejšega povečanja absolutnega števila limfocitov niso opazili.
English: CA184178
Slovenian: Študija CA184178
English: The mean (percent coefficient of variation) ipilimumab Cmin achieved at steady-state with a 3 mg/kg induction regimen was 19.4 µg/ml
Slovenian: Povprečne (odstotek koeficienta variacije) vrednosti Cmin ipilimumaba v stanju dinamičnega ravnovesja so bile pri odmerku 3 mg/kg med indukcijo 19,4 μg/ml
English: For ipilimumab-related uveitis, iritis, serous retinal detachment or episcleritis, topical corticosteroid eye drops should be considered as medically indicated.
Slovenian: Pri z ipilimumabom povzročenem uveitisu, iritisu, seroznem odstopu mrežnice ali episkleritisu bo morda indicirana topikalna uporaba kortikosteroidov v obliki kapljic za oko.
English: Very common (may affect more than 1 in 10 people) loss of appetite diarrhoea (watery, loose or soft stools), vomiting or feeling sick (nausea) skin rash, itching feeling tired or weak, reaction at site of injection, fever
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov) izguba apetita driska (vodeno, kašasto ali mehko blato), bruhanje ali slabost (navzea) kožni izpuščaj, srbenje občutek utrujenosti ali šibkosti, reakcije na mestu infundiranja zdravila, zvišana telesna temperatura
English: Severe endocrinopathies, including hypothyroidism, hyperthyroidism, adrenal insufficiency (including secondary adrenocortical insufficiency), hypophysitis (including hypopituitarism), diabetes mellitus, and diabetic ketoacidosis have been observed with ipilimumab in combination with nivolumab (see section 4.8).
Slovenian: Pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom so poročali o hudih endokrinopatijah, vključno s hipotiroidizmom, hipertiroidizmom, insuficienco nadledvičnih žlez (vključno s sekundarno adrenokortikalno insuficienco), vnetjem hipofize (vključno s hipopituitarizmom), diabetesom in diabetično ketoacidozo (glejte poglavje 4.8).
English: if you have any history of inflammation of the lungs
Slovenian: če ste kdaj imeli vnetje pljuč.
English: Signs and symptoms that your glands are not working properly may include headaches, blurry or double vision, tiredness, decreased sexual drive, behavioral changes.
Slovenian: Znaki in simptomi okvare delovanja žlez lahko vključujejo glavobole, zamegljen ali dvojni vid, utrujenost, zmanjšanje želje po spolnosti ali vedenjske spremembe.
English: Uncommon paraneoplastic syndrome Blood and lymphatic system disorders Common anaemia, lymphopenia
Slovenian: Občasni paraneoplastični sindrom Bolezni krvi in limfatičnega sistema Pogosti anemija, limfopenija
English: The total ipilimumab dose in mg = the patient's weight in kg × the prescribed dose in mg/kg.
Slovenian: Celotni odmerek ipilimumaba v mg = telesna masa bolnika v kg × predpisani odmerek v mg/kg.
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.
Slovenian: Če se blagi ali zmerni simptomi ponovijo ali vztrajajo 5 do 7 dni, je treba predvideni odmerek ipilimumaba zadržati in uvesti zdravljenje s kortikosteroidi (npr. prednizon 1 mg/kg peroralno enkrat na dan ali ekvivalent).
English: In patients who received 3 mg/kg ipilimumab monotherapy in MDX010-20, the most frequently reported adverse reactions (≥ 10% of patients) were diarrhoea, rash, pruritus, fatigue, nausea, vomiting, decreased appetite, and abdominal pain.
Slovenian: Pri bolnikih, ki so v študiji MDX010-20 prejemali ipilimumab v odmerku 3 mg/kg kot monoterapijo, so najpogosteje (≥ 10 % bolnikov) poročali o naslednjih neželenih učinkih: driski, izpuščaju, srbenju, utrujenosti, slabosti, bruhanju, zmanjšanju apetita in bolečinah v trebuhu.
English: When YERVOY is given in combination with nivolumab, you will first be given nivolumab followed by YERVOY.
Slovenian: V primeru zdravljenja z zdravilom YERVOY v kombinaciji z nivolumabom, boste najprej prejeli nivolumab, nato pa še zdravilo YERVOY.
English: When ipilimumab 3 mg/kg was administered in combination with nivolumab 1 mg/kg, the CL of ipilimumab was increased by 9% and the CL of nivolumab was increased by 29%, which was not considered clinically relevant.
Slovenian: Pri uporabi ipilimumaba v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg se je očistek ipilimumaba povečal za 9 %, očistek nivolumaba pa za 29 %, kar pa ne velja za klinično pomembno.
English: Not known solid organ transplant rejectionh Endocrine disorders Very common hypothyroidism hypothyroidism, hyperthyroidism
Slovenian: Neznana pogostnost zavrnitev presadka čvrstega organah Bolezni endokrinega sistema Zelo pogosti hipotiroidizem hipotiroidizem, hipertiroidizem
English: Cases of Vogt-Koyanagi-Harada syndrome and serous retinal detachment have been reported post-marketing (see section 4.8).
Slovenian: Po prihodu zdravila na trg so poročali o primerih Vogt-Koyanagi-Haradovega sindroma in seroznega odstopa mrežnice (glejte poglavje 4.8).
English: Progression Free Survival (Months)
Slovenian: Preživetje brez napredovanja bolezni (meseci)
English: Key elements of the Healthcare Professional Adverse Reaction Management Guide:
Slovenian: Ključni elementi Vodnika za zmanjševanje tveganj, namenjenega zdravstvenim delavcem:
English: YERVOY must be stored in a refrigerator (2°C to 8°C).
Slovenian: Zdravilo YERVOY shranjujte v hladilniku (2 °C do 8 °C).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 5 mg ipilimumab.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml koncentrata vsebuje 5 mg ipilimumaba.
English: a NE= not estimable
Slovenian: NA = ni ocenjeno
English: The median duration of treatment was 7.9 months (range: 1 day- 21.4+ months) in ipilimumab with nivolumab- treated patients and was 7.8 months (range: 1 days- 20.2+ months) in sunitinib-treated patients.
Slovenian: Pri bolnikih, ki so se zdravili z ipilimumabom v kombinaciji z nivolumabom, je mediana trajanja zdravljenja znašala 7,9 meseca (razpon: 1 dan - 21,4+ meseca), pri bolnikih, ki so se zdravili s sunitinibom, pa 7,8 meseca (razpon: 1 dan - 20,2+ meseca).
English: YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).
Slovenian: Karcinom ledvičnih celic (RCC - renal cell carcinoma) Zdravilo YERVOY je v kombinaciji z nivolumabom indicirano za prvo linijo zdravljenja odraslih bolnikov z napredovalim karcinomom ledvičnih celic s srednje ugodnim ali slabim prognostičnim obetom (glejte poglavje 5.1).
English: Signs and symptoms of hepatitis may include eye or skin yellowing (jaundice), pain on the right side of your stomach area, tiredness.
Slovenian: Znaki in simptomi hepatitisa lahko vključujejo rumeno obarvanje očesnih beločnic ali kože (zlatenica), bolečino v desnem predelu trebuha ali utrujenost.
English: Ipilimumab-induced rash and pruritus were predominantly mild or moderate (Grade 1 or 2) and responsive to symptomatic therapy.
Slovenian: Z ipilimumabom povzročeni izpuščaj in srbenje sta bila v glavnem blaga ali zmerna (stopnja 1 ali 2) in sta se odzvala na simptomatsko zdravljenje.
English: Ipilimumab 10 mg/kg was associated with higher rates of adverse events compared with the 3 mg/kg dose.
Slovenian: Uporaba ipilimumaba v odmerku 10 mg/kg je bila povezana z večjim deležem neželenih učinkov v primerjavi z uporabo odmerka 3 mg/kg.
English: Median OS for tumour PD-L1 expression ≥ 1% was not reached for ipilimumab in combination with nivolumab, and was 19.61 months in the sunitinib arm (HR = 0.52; 95% CI: 0.34, 0.78).
Slovenian: Pri ekspresiji PD-L1 tumorja ≥ 1 % mediana celokupnega preživetja v skupini z ipilimumabom v kombinaciji z nivolumabom ni bila dosežena, v skupini s sunitinibom pa je znašala 19,61 meseca (HR = 0,52; 95 % IZ: 0,34; 0,78).
English: In the population pharmacokinetic analysis of data from clinical studies in patients with metastatic melanoma, pre-existing mild and moderate renal impairment did not influence the CL of ipilimumab.
Slovenian: Analiza podatkov populacijske farmakokinetike iz kliničnih študij pri bolnikih z metastatskim melanomom je pokazala, da predhodna blaga in zmerna okvara ledvic nista vplivali na očistek ipilimumaba.
English: For the monotherapy phase, the first dose of nivolumab should be administered; 3 weeks after the last dose of the combination of ipilimumab and nivolumab if using 240 mg every 2 weeks; or 6 weeks after the last dose of the combination of ipilimumab and nivolumab if using 480 mg every 4 weeks.
Slovenian: V fazi zdravljenja v monoterapiji je prvi odmerek nivolumaba treba aplicirati: 3 tedne po zadnjem odmerku kombinacije ipilimumaba in nivolumaba, če se uporablja odmerek 240 mg vsaka 2 tedna; ali 6 tednov po zadnjem odmerku kombinacije ipilimumaba in nivolumaba, če se uporablja odmerek 480 mg vsake 4 tedne.
English: YERVOY concentrate is a clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates.
Slovenian: Koncentrat zdravila YERVOY je bistra do rahlo opalescentna, brezbarvna do svetlorumena tekočina, ki lahko vsebuje manjše število neznatnih delcev.
English: In the population pharmacokinetic analysis of data from clinical studies in patients with metastatic melanoma, pre-existing mild hepatic impairment did not influence the CL of ipilimumab.
Slovenian: Analiza podatkov populacijske farmakokinetike iz kliničnih študij pri bolnikih z metastatskim melanomom je pokazala, da predhodna blaga okvara jeter ni vplivala na očistek ipilimumaba.
English: YERVOY contains the active substance ipilimumab, a protein which helps your immune system to attack and destroy cancer cells by your immune cells.
Slovenian: To je beljakovina, ki celicam imunskega sistema pomaga, da napadejo in uničijo rakave celice.
English: Nivolumab+ipilimumab vs nivolumab (descriptive analysis) - HR (95% CI): 0.85 (0.68, 1.07)
Slovenian: nivolumab+ipilimumab v primerjavi z nivolumabom (opisna analiza) - HR (95 % IZ): 0,85 (0,68; 1,07)
English: There are no data on the use of ipilimumab in combination with nivolumab in patients with only a non clear-cell histology in first line RCC.
Slovenian: O uporabi ipilimumaba v kombinaciji z nivolumabom za prvo linijo zdravljenja RCC pri bolnikih z le nesvetlocelično histologijo ni podatkov.
English: In the Phase 3 study MDX010-20, (see section 5.1), patients received a median of 4 doses (range 1-4).
Slovenian: Mediano število odmerkov, ki so jih bolniki prejeli v študiji 3. faze MDX010-20 (glejte poglavje 5.1), je 4 odmerki (razpon od 1 do 4).
English: Grade 2 elevation in AST, ALT, or total bilirubin
Slovenian: zvišanje vrednosti AST, ALT ali skupnega bilirubina stopnje 2
English: For tumour PD-L1 expression < 1%, the median OS was 34.7 months for the ipilimumab in combination with nivolumab and was 32.2 months in the sunitinib arm (HR = 0.70; 95% CI: 0.54, 0.92).
Slovenian: Pri ekspresiji PD-L1 tumorja < 1 % je mediana celokupnega preživetja v skupini z ipilimumabom v kombinaciji z nivolumabom znašala 34,7 meseca, v skupini s sunitinibom pa 32,2 meseca (HR = 0,70; 95 % IZ: 0,54; 0,92).
English: Stable disease was achieved for 260 days in one patient on ipilimumab 3 mg/kg and approximately 14 months in one patient on ipilimumab 10 mg/kg.
Slovenian: Stabilna bolezen je bila pri enem bolniku, ki je prejemal ipilimumab v odmerku 3 mg/kg, dosežena za 260 dni, pri enem bolniku, ki je prejemal ipilimumab v odmerku 10 mg/kg, pa za približno 14 mesecev.
English: Musculoskeletal pain is a composite term which includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, and spinal pain.
Slovenian: Mišično skeletna bolečina je sestavljen izraz, ki obsega bolečino v hrbtu, bolečino v kosteh, mišično skeletno bolečino v predelu prsnega koša, mišično skeletno nelagodje, bolečino v mišicah, bolečino v vratu, bolečino v okončinah in bolečino v hrbtenici.
English: More than one vial of YERVOY concentrate may be needed to give the total dose for the patient.
Slovenian: Za aplikacijo celotnega odmerka boste morda potrebovali več kot le eno vialo s koncentratom zdravila YERVOY.
English: Patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of ipilimumab in combination with nivolumab (see sections 4.5 and 5.1).
Slovenian: Bolnike z anamnezo zasevkov v možganih ali s trenutnimi zasevki v možganih, z aktivno avtoimunsko boleznijo ali zdravstvenimi stanji, ki so zahtevala zdravljenje z zdravili za sistemsko zaviranje imunske odzivnosti, so iz kliničnih preskušanj uporabe ipilimumaba v kombinaciji z nivolumabom izključili (glejte poglavji 4.5 in 5.1).
English: YERVOY must not be administered as an intravenous push or bolus injection.
Slovenian: Zdravila YERVOY se ne sme dajati v obliki hitre intravenske ali bolus injekcije.
English: Tumour PD-L1 expression n nivolumab + ipilimumab Median OS (95% CI)
Slovenian: Ekspresija PD-L1 tumorja n nivolumab + ipilimumab Mediana OS (95% IZ)
English: Ipilimumab-induced rash and pruritus were predominantly mild (Grade 1) or moderate (Grade 2) and responsive to symptomatic therapy.
Slovenian: Z ipilimumabom povzročeni izpuščaj in srbenje sta bila v glavnem blaga (stopnja 1) ali zmerna (stopnja 2) in sta se odzvala na simptomatsko zdravljenje.
English: Immune-related endocrinopathy observed in clinical trials was generally controlled with immunosuppressive therapy and hormone replacement therapy.
Slovenian: Imunsko pogojene endokrinopatije, opažene v kliničnih preskušanjih, so se običajno dobro odzvale na imunosupresivno in hormonsko nadomestno zdravljenje.
English: Uncommon respiratory failure, acute respiratory distress syndromeb, lung infiltration, pulmonary oedema, pneumonitis, allergic rhinitis
Slovenian: Občasni odpoved dihanja, sindrom akutne dihalne stiskeb, infiltracija pljuč, pljučni edem, pljučnica, alergijski rinitis
English: The other ingredients are Tris-hydrochloride, sodium chloride (see section 2 "YERVOY contains sodium"), mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid and water for injections.
Slovenian: Druge sestavine zdravila so tris v obliki klorida, natrijev klorid (glejte poglavje 2 "Zdravilo YERVOY vsebuje natrij"), manitol (E421), pentetska kislina, polisorbat 80, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
English: YERVOY in combination with nivolumab should be permanently discontinued for:
Slovenian: Zdravljenje z zdravilom YERVOY v kombinaciji z nivolumabom je treba trajno ukiniti v primeru:
English: Uncommon chest pain
Slovenian: Občasni bolečina v prsnem košu
English: These include: a variation in the number of red blood cells (which carry oxygen), white blood cells (which are important in fighting infection) or platelets (cells which help the blood to clot) an abnormal variation of hormones and liver enzyme levels in the blood abnormal liver function test abnormal levels of calcium, sodium, phosphate or potassium in the blood presence of blood or proteins in the urine an abnormally high alkalinity of the blood and other body tissues kidneys unable to remove acids from blood normally presence of antibodies in the blood against some of your own cells
Slovenian: Te spremembe so: spremembe v številu rdečih krvnih celic (celice, ki po krvi prenašajo kisik), belih krvnih celic (celice, ki so pomembne za obrambo pred okužbami) ali trombocitov (celice, ki so potrebne za normalno strjevanje krvi) nenormalne spremembe v vrednostih hormonov in jetrnih encimov v krvi nenormalni rezultati preiskav delovanja jeter nenormalne vrednosti kalcija, natrija, fosfatov ali kalija v krvi prisotnost krvi ali beljakovin v urinu nenormalno močna bazičnost krvi in drugih telesnih tkiv nesposobnost ledvic za normalno odstranjevanje kislin iz krvi prisotnost protiteles v krvi proti nekaterim telesu lastnim celicam
English: Based on population pharmacokinetic results, no specific dose adjustment is necessary in patients with mild to moderate renal dysfunction (see section 5.2).
Slovenian: Na osnovi rezultatov populacijske farmakokinetike pri bolnikih z blago do zmerno okvaro ledvic odmerka ni treba posebej prilagajati (glejte poglavje 5.2).
English: Grade 2 elevation in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin
Slovenian: Imunsko pogojeni hepatitis zvišanje vrednosti aspartat-aminotransferaze (AST), alanin-aminotransferaze (ALT) ali skupnega bilirubina stopnje 2
English: Increases in AST and ALT of any severity were reported in 1% and 2% of patients, respectively.
Slovenian: O zvišanju vrednosti AST vseh jakosti so poročali pri 1 % bolnikov, o zvišanju vrednosti ALT vseh jakosti pa pri 2 % bolnikov.
English: The safety data for patients with unresectable or metastatic melanoma, treated with ipilimumab (3 mg/kg, with a minimum of 3 year follow-up) and enrolled in multi-national, prospective, observational study CA184143 (N= 1151) were similar to what has been reported in ipilimumab clinical trials for advanced melanoma.
Slovenian: Pri bolnikih z neoperabilnim ali metastatskim melanomom, ki so bili vključeni v multinacionalno, prospektivno opazovalno študijo CA184143 (N= 1151) in so se zdravili z ipilimumabom (3 mg/kg, najmanj 3 leta spremljanja), je bil varnostni profil podoben profilu, o katerem so poročali v kliničnih preskušanjih z ipilimumabom za zdravljenje napredovalega melanoma.
English: Fatal Guillain-Barré syndrome has been reported in clinical trials.
Slovenian: V kliničnih preskušanjih so poročali o pojavu Guillain-Barréjevega sindroma, ki je bil usoden.
English: sodium chloride 9 mg/ml (0.9%) solution for injection; or
Slovenian: 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ali
English: Management of immune-related adverse reactions may require withholding of a dose or permanent discontinuation of YERVOY therapy and institution of systemic high-dose corticosteroid.
Slovenian: V primeru pojava imunsko pogojenih neželenih učinkov bo morda treba zadržati odmerek ali zdravljenje z zdravilom YERVOY trajno ukiniti in uvesti zdravljenje z visokimi odmerki sistemskih kortikosteroidov.
English: Overall survival (OS) advantage of ipilimumab at the recommended dose of 3 mg/kg in patients with previously-treated advanced (unresectable or metastatic) melanoma was demonstrated in a Phase 3 study (MDX010-20).
Slovenian: Korist ipilimumaba za celokupno preživetje pri uporabi priporočenega odmerka 3 mg/kg so pri bolnikih s predhodno že zdravljenim napredovalim (neoperabilnim ali metastatskim) melanomom dokazali v študiji 3. faze (MDX010-20).
English: The safety and efficacy of ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg nivolumab 3 mg/kg vs. ipilimumab 3 mg/kg monotherapy for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, double-blind study (CA209067).
Slovenian: Varnost in učinkovitost ipilimumaba v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg ali nivolumaba v odmerku 3 mg/kg v primerjavi z ipilimumabom v odmerku 3 mg/kg v monoterapiji pri zdravljenju napredovalega (neoperabilnega ali metastatskega) melanoma so vrednotili v randomizirani, dvojno slepi študiji 3. faze (CA209067).
English: Gently mix the infusion by manual rotation.
Slovenian: Infuzijo z vrtenjem v rokah nežno premešajte.
English: Physicians should consider the delayed onset of ipilimumab in combination with nivolumab effect before initiating treatment in patients with rapidly progressing disease (see section 5.1).
Slovenian: Pri bolnikih s hitro napredujočo obliko bolezni je pred uvedbo zdravljenja treba upoštevati zakasnjen nastop učinka ipilimumaba v kombinaciji z nivolumabom (glejte poglavje 5.1).
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.
Slovenian: Bolnike z izhodiščno oceno telesne zmogljivosti ≥ 2, aktivnimi zasevki v možganih ali avtoimunsko boleznijo ter bolnike, ki so se pred vključitvijo v študijo zdravili z zdravili za sistemsko zaviranje imunske odzivnosti, so iz kliničnih preskušanj ipilimumaba v kombinaciji z nivolumabom izključili.
English: Ipilimumab as monotherapy (see section 4.2)
Slovenian: Ipilimumab v monoterapiji (glejte poglavje 4.2)
English: Uncommon hyponatremia, alkalosis, hypophosphatemia, tumour lysis syndrome, hypocalcaemiad Psychiatric disorders
Slovenian: Občasni hiponatriemija, alkaloza, hipofosfatemija, sindrom tumorske lize, hipokalciemijad Psihiatrične motnje
English: Signs and symptoms of colitis may include diarrhoea (watery, loose or soft stools), an increased number of bowel movements than usual, blood in your stools or darker-coloured stools, pain or tenderness in your stomach area.
Slovenian: Znaki in simptomi kolitisa lahko vključujejo drisko (vodeno, redko ali mehko blato), pogostejše odvajanje blata od običajnega, kri v blatu ali temno obarvano blato, bolečino ali občutljivost v predelu trebuha.
English: Ipilimumab therapy was discontinued for adverse reactions in 10% of patients.
Slovenian: Zaradi pojava neželenih učinkov je bilo zdravljenje z ipilimumabom prekinjeno pri 10 % bolnikov.
English: Hazard ratioa 99.8% CI p-valueb, c
Slovenian: 99,1% IZ p-vrednostb,h