FrancophonIA/ELRC3.0 huggingface dataset:
English: Nivolumab+ipilimumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: < 0.0001 Nivolumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.55 (0.42, 0.73); p-value: < 0.0001
Slovenian: nivolumab+ipilimumab v primerjavi z ipilimumabom (primarna analiza) - HR (99,5 % IZ): 0,42 (0,32; 0,56); p-vrednost: < 0,0001
English: Additional treatment with ipilimumab (re-treatment) was offered to those who developed PD after initial clinical response (PR or CR) or after SD (per the modified WHO criteria) > 3 months from the first tumour assessment.
Slovenian: Bolnikom, pri katerih je po začetnem kliničnem odzivu (delni ali popolni odziv) ali stabilni bolezni (po modificiranih kriterijih SZO), ki je trajala več kot 3 mesece po prvem vrednotenju tumorja, prišlo do napredovanja bolezni, je bilo ponujeno dodatno zdravljenje z ipilimumabom (ponovno zdravljenje).
English: Median time to onset was 1.2 months (range: 0.0-22.6).
Slovenian: Mediani čas do pojava je znašal 1,2 meseca (razpon: 0,0-22,6).
English: Key secondary endpoints were OS in the ipilimumab+ gp100 group vs. the ipilimumab monotherapy group and in the ipilimumab monotherapy group vs. the gp100 group.
Slovenian: Ključni sekundarni opazovani dogodek je bilo celokupno preživetje v skupini, ki je prejemala ipilimumab + gp100, v primerjavi s skupino, ki je prejemala samo ipilimumab, ter v skupini, ki je prejemala samo ipilimumab, v primerjavi s skupino, ki je prejemala samo gp100.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of liver function test abnormalities was 18.5% (101/547).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z ipilimumabom v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg, je pojavnost nenormalnih izvidov delovanja jeter znašala 18,5% (101/547).
English: Common confusional state
Slovenian: Pogosti zmedenost
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).
Slovenian: Pri bolnikih z melanomom, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg, je pojavnost bolezni ščitnice znašala 25,2 % (113/448).
English: Ipilimumab has been shown to be present at very low levels in milk from cynomolgus monkeys treated during pregnancy.
Slovenian: Pri opicah cynomolgus, ki so ipilimumab prejemale med brejostjo, se je le-ta v zelo majhnih količinah izločal v mleko.
English: In the ipilimumab 3 mg/kg monotherapy group, rash and pruritus of any severity were each reported in 26% of patients.
Slovenian: V skupini, ki je prejemala ipilimumab v odmerku 3 mg/kg kot monoterapijo, so o pojavu kožnega izpuščaja in srbenja vseh jakosti poročali pri 26 % bolnikov.
English: Common hypotension, flushing, hot flush
Slovenian: Žilne bolezni Pogosti hipotenzija, zardevanje, vročinski oblivi
English: nivolumab Median OS (95% CI)
Slovenian: nivolumab Mediana OS (95% IZ)
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Slovenian: Pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom so poročali o hudi pljučnici ali bolezni pljučnega intersticija, vključno s smrtnimi primeri (glejte poglavje 4.8).
English: Ipilimumab 1 mg/kg over 30 minutes
Slovenian: infuzije ipilimumab 1 mg/kg v obliki 30-minutne i.v.
English: Median OS in the subgroup with brain metastases at baseline was 5.67 months at the recommended dose of 3 mg/kg.
Slovenian: Pri uporabi priporočenega odmerka 3 mg/kg je mediana celokupnega preživetja v podskupini bolnikov z zasevki v možganih v izhodišču znašala 5,67 meseca.
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.
Slovenian: Pri bolnikih, ki so v študiji MDX010-20 ipilimumab prejemali v odmerku 3 mg/kg kot monoterapijo, je bil mediani čas do pojava zmernih do hudih ali usodnih (stopnje 2 do 5) neželenih učinkov za kožo 3 tedne od začetka zdravljenja (razpon od 0,9 do 16 tednov).
English: Histiocytosis haematophagic has been reported in relation to ipilimumab therapy.
Slovenian: V povezavi z zdravljenjem z ipilimumabom so poročali o hematofagni histiocitozi.
English: Severe infusion reactions have been reported in clinical trials of ipilimumab or ipilimumab in combination with nivolumab (see section 4.8).
Slovenian: V kliničnih preskušanjih ipilimumaba ali ipilimumaba v kombinaciji z nivolumabom so poročali o pojavu hudih infuzijskih reakcij (glejte poglavje 4.8).
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been rarely reported with Ipilimumab in clinical studies and during postmarketing use.
Slovenian: V kliničnih študijah in med uporabo ipilimumaba po njegovem prihodu na trg so poročali o redkih primerih reakcije na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS-Drug Reaction with Eosinophilia and Systemic Symptoms).
English: For symptomatic hypothyroidism, ipilimumab in combination with nivolumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Slovenian: V primeru simptomatskega hipotiroidizma je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati in po potrebi uvesti zdravljenje z nadomeščanjem ščitničnega hormona.
English: Sequential administration with vemurafenib
Slovenian: Zaporedna uporaba z vemurafenibom
English: Fatal hepatic failure has been reported in < 1% of patients who received ipilimumab 3 mg/kg monotherapy.
Slovenian: O usodni odpovedi jeter so poročali pri manj kot 1 % bolnikov, ki so ipilimumab v odmerku 3 mg/kg prejemali kot monoterapijo.
English: mg/kg
Slovenian: 3,0 mg/k g
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).
Slovenian: Pri bolnikih z RCC, ki so se zdravili z ipilimumabom v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg, je pojavnost nefritisa ali okvare delovanja ledvic znašala 8,8 % (48/547).
English: Incidental cases of pemphigoid have been reported during post-marketing use.
Slovenian: Pri uporabi zdravila po prihodu na trg so poročali o slučajnih primerih pemfigoida.
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg, the incidence of liver function test abnormalities was 29.5% (132/448).
Slovenian: Pri bolnikih z melanomom, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg, je pojavnost nenormalnih izvidov delovanja jeter znašala 29,5 % (132/448).
English: Severe hepatitis has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Slovenian: Pri zdravljenju z ipilimumabom v kombinaciji z nivolumabom so poročali o hudem hepatitisu (glejte poglavje 4.8).
English: Grade 2, Grade 3, and Grade 4 cases were reported in 4.7% (21/448), 1.1% (5/448), and 0.2% (1/448) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 4,7% (21/448) bolnikov, o primerih stopnje 3 pri 1,1% (5/448) bolnikov, o primerih stopnje 4 pa pri 0,2% (1/448) bolnikov.
English: Liver function tests (LFTs) and thyroid function tests should be evaluated at baseline and before each dose of YERVOY.
Slovenian: Pred uvedbo zdravljenja in pred aplikacijo vsakega nadaljnjega odmerka zdravila YERVOY je treba ovrednotiti teste delovanja jeter in ščitnice.
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
Slovenian: Pri bolnikih z melanomom, ki so se zdravili z ipilimumabom v odmerku 3 mg/kg v kombinaciji z nivolumabom v odmerku 1 mg/kg, je pojavnost nefritisa ali okvare delovanja ledvic znašala 5,1 % (23/448).
English: YERVOY must be administered with caution in patients with transaminase levels ≥ 5 x ULN or bilirubin levels > 3 x ULN at baseline (see section 5.1).
Slovenian: Pri bolnikih, ki imajo pred začetkom zdravljenja vrednosti aminotransferaze ≥ 5 x ZNV ali bilirubina > 3 x ZNV, je treba zdravilo YERVOY uporabljati previdno (glejte poglavje 5.1).
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.
Slovenian: Preden boste zdravilo prejeli, bodo del ali celotno vsebino viale razredčili z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ali s 50 mg/ml (5 %) raztopino glukoze za injiciranje.
English: Grade 2 or 3 creatinine elevation Withhold dose(s) until creatinine returns to baseline and management with corticosteroids is complete
Slovenian: Aplikacijo odmerka (odmerkov) zadržite, dokler se vrednost kreatinina ne povrne do izhodiščne vrednosti in zdravljenje s kortikosteroidi ni končano.
English: Very common diarrhoeac, vomiting, nausea
Slovenian: Bolezni prebavil Zelo pogosti driskac, bruhanje, slabost
English: To dilute the YERVOY concentrate, you can use either: sodium chloride 9 mg/ml (0.9%) solution for injection; or 50 mg/ml (5%) glucose solution for injection
Slovenian: Za redčenje koncentrata zdravila YERVOY lahko uporabite: 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje ali 50 mg/ml (5 %) raztopino glukoze za injiciranje.
English: Eye disorders Common blurred vision, eye pain
Slovenian: Očesne bolezni Pogosti zamegljen vid, bolečina v očesu
English: Ipilimumab
Slovenian: Imunogenost
English: Ipilimumab-induced rash and pruritus should be managed based on severity.
Slovenian: Z ipilimumabom povzročeni izpuščaj ali srbenje je treba zdraviti glede na jakost.
English: ORR (95% CI) by tumour PD-L1 expression n=210
Slovenian: Delež trajanja ≥12 mesecev Delež trajanja ≥24 mesecev Delež objektivnega odziva (ORR) (95% IZ) glede na ekspresijo PD-L1 tumorja n=210
English: Common adrenal insufficiency, hypopituitarism, hypophysitis, hyperthyroidism, thyroiditis adrenal insufficiencyc, hypophysitisc,
Slovenian: Pogosti insuficienca nadledvičnih žlez, hipopituitarizem, vnetje hipofize, hipertiroidizem, vnetje ščitnice insuficienca nadledvičnih žlezc, vnetje hipofizec, vnetje ščitnice, diabetesc
English: Ipilimumab in combination with nivolumab should be withheld for Grade 3 rash and discontinued for Grade 4 rash.
Slovenian: V primeru izpuščaja stopnje 3 je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati, v primeru izpuščaja stopnje 4 pa zdravljenje ukiniti.
English: n ipilimumab Median OS (95% CI)
Slovenian: n ipilimumab Mediana OS (95% IZ)
English: YERVOY in combination with nivolumab Melanoma
Slovenian: Zdravilo YERVOY v kombinaciji z nivolumabom Melanom
English: Once rash or pruritus is controlled, initiation of corticosteroid taper should be based on clinical judgment.
Slovenian: Ko sta izpuščaj in srbenje pod nadzorom, je treba na osnovi klinične presoje začeti odmerek kortikosteroida postopno zmanjševati.
English: For symptomatic diabetes, ipilimumab in combination with nivolumab should be withheld, and insulin replacement should be initiated as needed.
Slovenian: V primeru simptomatskega diabetesa je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom zadržati in po potrebi uvesti zdravljenje z insulinom.
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.
Slovenian: V primeru zvišanja serumskega kreatinina stopnje 4 je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 1 do 2 mg/kg/dan metilprednizolona.
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
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov) bolečina zaradi raka zmanjšano delovanje ščitnice, ki lahko povzroči utrujenost ali povečanje telesne mase, zmanjšano delovanje (hipopituitarizem) ali vnetje (hipofizitis) hipofize (žleza, ki leži v koščeni vdolbini lobanjskega dna) dehidracija zmedenost okvara živcev (s posledično bolečino, šibkostjo ali krči), omotica, glavobol zamegljen vid, bolečina v očesu nizek krvni tlak, prehodna pordelost obraza in vratu, občutek hude vročine z znojenjem in hitrim utripanjem srca težko dihanje (dispneja), kašelj krvavitev v želodcu ali črevesu, vnetje črevesa (kolitis), zaprtost, zgaga, bolečina v trebuhu nenormalno delovanje jeter vnetje sluznice nekaterih organov vnetje in rdečina kože, spremembe obarvanosti posameznih predelov kože (vitiligo), koprivnica (srbeči in izbočeni kožni izpuščaji), izpadanje ali redčenje las, čezmerno nočno znojenje, suha koža bolečina v mišicah in sklepih (artralgija), mišični krči drgetanje, pomanjkanje energije, edem (otekanje), bolečina gripi podobna bolezen zmanjšanje telesne mase
English: Respiratory, thoracic and mediastinal disorders Common dyspnea, cough
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti dispneja, kašelj
English: ipilimumab Median OS (95% CI)
Slovenian: ipilimumab Mediana OS (95% IZ)
English: In addition, iritis, haemolytic anaemia, amylase elevations, multi-organ failure, and pneumonitis have been reported in patients treated with ipilimumab 3 mg/kg + gp100 peptide vaccine in MDX010-20.
Slovenian: Razen tega pa so pri bolnikih, ki so se v študiji MDX010-20 zdravili z ipilimumabom v odmerku 3 mg/kg v kombinaciji s peptidnim cepivom gp100, poročali še o iritisu, hemolitični anemiji, zvišanju vrednosti amilaze, odpovedi več organov in pljučnici.
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)
Slovenian: nivolumab+ipilimumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,42 (0,31; 0,55) nivolumab v primerjavi z ipilimumabom - razmerje ogroženosti: 0,44 (0,34; 0,58) nivolumab+ipilimumab v primerjavi z nivolumabom - razmerje ogroženosti: 0,94 (0,69; 1,28)
English: AE, n (%)
Slovenian: Neželeni učinek, n (%)
English: Upon improvement, ipilimumab in combination with nivolumab may be resumed after corticosteroid taper.
Slovenian: Po izboljšanju in postopnem zmanjšanju odmerka kortikosteroida se zdravljenje z ipilimumabom v kombinaciji z nivolumabom lahko nadaljuje.
English: Grade 2, Grade 3, and Grade 4 cases were reported in 1.6% (7/448), 0.9% (4/448), and 0.7% (3/448) of patients, respectively.
Slovenian: O primerih stopnje 2 so poročali pri 1,6% (7/448) bolnikov, o primerih stopnje 3 pri 0,9% (4/448) bolnikov, o primerih stopnje 4 pa pri 0,7% (3/448) bolnikov.
English: Ipilimumab is associated with serious immune-related neurological reactions.
Slovenian: Uporaba ipilimumaba je bila povezana s pojavom resnih imunsko pogojenih nevroloških učinkov.
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)
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov) resna okužba pljuč (pljučnica), okužbe zgornjih dihal, vnetje oči (konjunktivitis) povečanje števila eozinofilcev (vrste belih krvnih celic) alergijska reakcija, reakcije, povezane z infundiranjem zdravila zmanjšano izločanje hormonov nadledvičnih žlez (parni žlezi, ki se nahajata nad ledvicami), zmanjšano delovanje (hipopituitarizem) ali vnetje (hipofizitis) hipofize, žleze, ki leži v koščeni vdolbini lobanjskega dna, oteklina žleze ščitnice, sladkorna bolezen dehidracija vnetje jeter vnetje živcev (kar lahko povzroči odrevenelost, oslabelost, zbadanje ali pekoč občutek v rokah ali nogah), omotica vnetje oči, ki povzroča bolečino in rdečino, zamegljen vid hitro utripanje srca visok krvni tlak (hipertenzija) vnetje pljuč (pljučnica, za katero je značilen kašelj in težave z dihanjem), krvni strdki, kopičenje tekočine okrog pljuč, kašelj razjede in vnetje ustne sluznice (stomatitis), vnetje trebušne slinavke (pankreatitis), zaprtost, suha usta sprememba barve kože v zaplatah (vitiligo), suha koža, rdečina kože, neobičajno izpadanje ali redčenje las, koprivnica (srbeč, izbočen izpuščaj) vnetje sklepov (artritis), mišični krči, oslabelost mišic odpoved ledvic (vključno z nenadno odpovedjo delovanja ledvic) edem (oteklina), bolečina, bolečina v prsnem košu, mrzlica
English: Each vial contains 200 mg ipilimumab.
Slovenian: Ena viala vsebuje 200 mg ipilimumaba.
English: Median OS (months) (95% CI)
Slovenian: Mediana celokupnega preživetja (meseci) (95 % IZ)
English: Withhold dose(s) until symptoms resolve and management with corticosteroids is completeb
Slovenian: Aplikacijo odmerka (odmerkov) zadržite, dokler simptomi ne izzvenijo in zdravljenje s kortikosteroidi ni končano.
English: • Healthcare Professional Adverse Reaction Management Guide
Slovenian: • Vodnik za zmanjševanje tveganj, namenjen zdravstvenim delavcem,
English: Immune system disorders Uncommon hypersensitivity Very rare anaphylactic reaction Endocrine disorders Common hypopituitarism (including hypophysitis)c, hypothyroidismc Uncommon adrenal insufficiencyc, secondary adrenocortical insufficiencyd, hyperthyroidismc, hypogonadism
Slovenian: Zelo redki anafilaktična reakcija Bolezni endokrinega sistema Pogosti hipopituitarizem (vključno s hipofizitisom)c, hipotiroidizemc
English: Ipilimumab in combination with nivolumab must be permanently discontinued for life-threatening hyperthyroidism or hypothyroidism.
Slovenian: V primeru življenje ogrožajočega hipertiroidizma ali hipotiroidizma je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukiniti.
English: Patients may present with muscle weakness.
Slovenian: Pri bolnikih je lahko prisotna mišična oslabelost, pojavi pa se lahko tudi senzorična nevropatija.
English: Discontinue YERVOY if resolution to Grade 1 or Grade 0 or return to baseline does not occur.
Slovenian: Če se stanje ne izboljša do stopnje 1 ali stopnje 0 ali ne vzpostavi izhodiščno stanje, zdravljenje z zdravilom YERVOY ukinite.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 5 mg ipilimumab.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En ml koncentrata vsebuje 5 mg ipilimumaba.
English: Fatal hepatic failure has been reported in clinical trials (see section 4.8).
Slovenian: V kliničnih preskušanjih so poročali o odpovedi jeter, ki je bila usodna (glejte poglavje 4.8).
English: Clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates and has a pH of 7.0 and an osmolarity of 260-300 mOsm/kg.
Slovenian: pH vrednost tekočine je 7,0, osmolarnost pa 260-300 mOsm/kg.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg, the incidence of hypersensitivity/infusion reactions was 4.0% (22/547); all were Grade 1 or 2 in severity.
Slovenian: Pri bolnikih, ki so se zdravili z ipilimumabom v odmerku 1 mg/kg v kombinaciji z nivolumabom v odmerku 3 mg/kg je pojavnost preobčutljivostnih/infuzijskih reakcij znašala 4,0 % (22/547).
English: NAME OF THE MEDICINAL PRODUCT YERVOY 5 mg/ml concentrate for solution for infusion 2.
Slovenian: YERVOY 5 mg/ml koncentrat za raztopino za infundiranje 2.
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.
Slovenian: V primeru pljučnice stopnje 3 ali 4 je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukiniti in uvesti zdravljenje s kortikosteroidi v odmerku, ki ustreza 2 do 4 mg/kg/dan metilprednizolona.
English: In the ipilimumab 3 mg/kg monotherapy group, diarrhoea and colitis of any severity were reported in 27% and 8%, respectively.
Slovenian: V skupini, ki je ipilimumab v odmerku 3 mg/kg prejemala kot monoterapijo, so o driski vseh jakosti poročali pri 27 % bolnikov, o kolitisu vseh jakosti pa pri 8 % bolnikov.
English: Ipilimumab in combination with nivolumab must be permanently discontinued for life-threatening (Grade 4) hypophysitis.
Slovenian: V primeru življenje ogrožajočega (stopnja 4) vnetja hipofize je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukiniti.
English: Pregnant monkeys received ipilimumab every 3 weeks from the onset of organogenesis in the first trimester through delivery, at exposure (AUC) levels either similar to or higher than those associated with the clinical dose of 3 mg/kg of ipilimumab.
Slovenian: Izpostavljenost (AUC) ipilimumabu je bila podobna ali večja kot pri klinični uporabi ipilimumaba v odmerku 3 mg/kg.
English: Ipilimumab in combination with nivolumab must be permanently discontinued for life-threatening diabetes.
Slovenian: V primeru življenje ogrožajočega diabetesa je treba zdravljenje z ipilimumabom v kombinaciji z nivolumabom trajno ukiniti.
English: Common dermatitis, erythema, vitiligo, urticaria, eczemad, alopecia, night sweats, dry skin Uncommon toxic epidermal necrolysisb,c, leukocytoclastic vasculitis, skin exfoliation, hair colour changesd
Slovenian: Občasni toksična epidermalna nekrolizab,c, levkocitoklastični vaskulitis, luščenje kože, spremembe barve lasd
English: - inflammation of hormone producing glands (especially the pituitary, adrenal and thyroid glands) that may affect how these glands work.
Slovenian: - vnetje žlez, ki izločajo hormone (še posebej hipofize, nadledvične žleze in ščitnice).
English: Withhold dose(s) until symptoms resolve and management with corticosteroids is complete
Slovenian: Aplikacijo odmerka (odmerkov) zadržite, dokler simptomi ne izzvenijo in zdravljenje s kortikosteroidi ni končano.b
English: However, significant exposure of ipilimumab to the infant through breast milk is not expected and no effects on the breast-fed infant are anticipated.
Slovenian: Pri dojenem otroku sicer ne pričakujemo pomembnejše izpostavljenosti ipilimumabu ali kakršnihkoli učinkov, vendar pa se o dojenju med ali po zdravljenju z zdravilom YERVOY posvetujte z zdravnikom.