FrancophonIA/ELRC3.0 huggingface dataset:
English: Nivolumab+Ipilimumab (events: 111/210), median and 95% CI: 11.10 (7.98, 22.18) ──Δ─── Nivolumab (events: 125/208), median and 95% CI: 5.32 (2.83, 7.06) Ipilimumab (events: 159/202), median and 95% CI: 2.83 (2.76, 3.09)
Maltese: Nivolumab+Ipilimumab (avvenimenti: 111/210), medjan u 95 % CI: 11.10 (7.98, 22.18) ──Δ─── Nivolumab (avvenimenti: 125/208), medjan u 95 % CI: 5.32 (2.83, 7.06)
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%).
Maltese: It-titjib fl-OS kien simili bejn ipilimumab ma' nivolumab u monoterapija b'nivolumab f'pazjenti b'espressjoni għolja ta' PD-L1 tat-tumur (PD-L1 ≥ 1%).
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.
Maltese: Ġew irrappurtati każijiet ta' Grad 2, Grad 3, u Grad 4 f'4.7% (21/448), 1.1% (5/448), u 0.2% (1/448) tal-pazjenti, rispettivament.
English: Randomised phase 3 study of receive ipilimumab in combination with nivolumab or nivolumab as monotherapy vs. ipilimumab as monotherapy (CA209067)
Maltese: Studju ta' fażi 3 randomizzat ta' riċeviment ta' ipilimumab flimkien ma' nivolumab jew nivolumab bħala monoterapija kontra ipilimumab bħala monoterapija (CA209067)
English: Hydrochloric acid (for pH-adjustment)
Maltese: Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH)
English: Liver biopsies from patients who had immune-related hepatotoxicity showed evidence of acute inflammation (neutrophils, lymphocytes, and macrophages).
Maltese: Bijopsiji tal-fwied minn pazjenti li kellhom epatotossiċità relatata mal-immunità, urew evidenza ta' infjammazzjoni akuta (newtrofili, limfoċiti, u makrofaġi).
English: How to store YERVOY
Maltese: L-infużjoni YERVOY
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.
Maltese: Reazzjonijiet avversi rrapportati f'pazjenti b'melanoma avvanzata li kienu kkurati b' ipilimumab 3 mg/kg fil-provi kliniċi (n = 767) u minn sorveljanza ta' wara t-tqegħid fis-suq huma ppreżentati f'Tabella 4.
English: Solid organ transplant rejection
Maltese: Rifjut tat-trapjant tal-organi solidi
English: Ipilimumab is a T-cell potentiator that enables the immune response (see section 5.1) and may interfere with immunosuppressive therapy, resulting in an exacerbation of the underlying disease or increased risk of graft rejection.
Maltese: Ipilimumab hu potenzjatur taċ-ċelluli T li jattiva r-rispons immuni (ara sezzjoni 5.1) u jista' jinterferixxi mat-terapija immunosoppressiva, li jirriżulta f'aggravament talmarda eżistenti jew żieda fir-rifjut tat-trapjant.
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of rash was 65.0% (291/448).
Maltese: F'pazjenti kkurati b'ipilimumab 3 mg/kg flimkien ma' nivolumab 1 mg/kg fil-melanoma, l-inċidenza ta' raxx kienet 65.0% (291/448).
English: Adverse events leading to discontinuation in the 10 mg/kg and 3 mg/kg groups occurred in 31% and 19% of patients, with AEs leading to death in 4 and 2 patients, respectively.
Maltese: avvenimenti avversi li wasslu għat-twaqqif fil-gruppi ta' 10 mg/kg u 3 mg/kg seħħew f'31 % u fi 19 %tal-pazjenti, b'AEs li wasslu għal mewt f'4 u 2 pazjenti, rispettivament.
English: Uncommon mental status changes, depression, decreased libido Nervous system disorders
Maltese: Mhux komuni tibdil fl-istat mentali, dipressjoni, tnaqqis fil-libido Disturbi fis-sistema nervuża
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).
Maltese: F'pazjenti li kienu qed jingħataw kura b'ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg f'RCC, l-inċidenza ta' disturbi tat-tirojde kienet ta' 27.2 % (149/547).
English: A total of 1096 patients were randomised in the trial, of which 847 patients had intermediate/poor-risk RCC and received either ipilimumab 1 mg/kg (n = 425) administered intravenously over 30 minutes in combination with nivolumab administered intravenously over 60 minutes every 3 weeks for 4 doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks or sunitinib (n = 422) 50 mg daily, administered orally for 4 weeks followed by 2 weeks off, every cycle.
Maltese: Total ta' 1096 pazjent kienu randomizzati fil-prova, li minnhom 847 pazjent kellhom RCC b'riskju intermedju/fqir u kienu rċevew jew ipilimumab 1mg/kg (n = 425) mogħti ġol-vini fuq perjodu ta' nofs siegħa f'kombinazzjoni ma' nivolumab ġol-vini fuq perjodu ta' siegħa kull 3 ġimgħat għal 4 dożi segwit minn monoterapija b'nivolumab ta' 3 mg/kg kull ġimgħatejn jew sunitinib (n = 422) 50 mg kuljum, b'mod orali għal 4 ġimgħat segwit minn ġimgħatejn mingħajr kura, kull ċiklu.
English: Median time to onset was 2.6 months (range: 0.7-12.6).
Maltese: Iż-żmien medjan għall-bidu kien 2.6 xhur (medda: 0.7-12.6).
English: Adverse reactions reported in the pooled dataset for patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg (n = 448) are presented in Table 5.
Maltese: Ir-reazzjonijiet avversi rrapportati fis-sett ta' data miġbur għall-pazjenti li ngħataw kura b'ipilimumab 3 mg/kg f'kombinazzjoni ma' nivolumab 1 mg/kg (n = 448) huma ppreżentati fit-Tabella 5.
English: However, for women above 50 years of age, the data supporting an OS benefit of ipilimumab treatment were limited.
Maltese: Madankollu, għal nisa li għandhom iktar minn 50 sena, id-dejta li tappoġġa benefiċċju OS ta' kura b' ipilimumab kienet limitata.
English: Median (95% CI)
Maltese: OS medjana (95 % CI)
English: The YERVOY infusion is compatible with:
Maltese: Yervoy f'kombinazzjoni ma' nivolumab:
English: ORRs were higher for the combination of nivolumab and ipilimumab relative to nivolumab monotherapy across tumour PD-L1 expression levels (Table 11) after 28 months of follow-up, with a best overall response of complete response correlating to an improved survival rate.
Maltese: L-ORRs kienu ogħla għall-kombinazzjoni ta' nivolumab u ipilimumab meta mqabbel ma' monoterapija b'nivolumab fil-livelli tal-espressjoni ta' PD-L1 tat-tumur (Tabella 11) wara 28 xahar ta' segwitu, bl-aħjar rispons globali ta' rispons komplet jikkorelata ma' titjib fir-rata tas-sopravivenza.
English: In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of pneumonitis including interstitial lung disease was 6.2% (34/547).
Maltese: F'pazjenti li kienu qed jingħataw kura b'ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg f'RCC, l-inċidenza ta' pulmonite inkluż mard tal-interstizzju tal-pulmun kienet ta' 6.2 % (34/547).
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).
Maltese: F'pazjenti kkurati b'ipilimumab 3 mg/kg flimkien ma' nivolumab 1 mg/kg, l-inċidenza ta' anormalitajiet fit-test tal-funzjoni tal-fwied kienet 29.5% (132/448).
English: Median time to onset was 2.6 months (range: 0.5-21.8).
Maltese: Iż-żmien medjan għall-bidu kien 2.6 xhur (medda: 0.5-21.8).
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).
Maltese: F'pazjenti li kienu qed jingħataw kura b'ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg f'RCC, l-inċidenza ta' abnormalitajiet fit-testijiet tal-funzjoni tal-fwied kienet ta' 18.5 % (101/547).
English: Disposal:
Maltese: Ġilda:
English: nivolumab + ipilimumab Median OS (95% CI)
Maltese: nivolumab + ipilimumab OS medjana (95 % CI)
English: Ipilimumab 10 mg/kg was associated with higher rates of adverse events compared with the 3 mg/kg dose.
Maltese: Ipilimumab 10 mg/kg ġiet assoċjata ma' rati ogħla ta' avvenimenti avversi meta mqabbla mad-doża ta' 3 mg/kg.
English: In clinical trials, liver biopsies from patients who had immune-related hepatotoxicity showed evidence of acute inflammation (neutrophils, lymphocytes, and macrophages).
Maltese: Fil-provi kliniċi, bijopsiji tal-fwied minn pazjenti li kellhom epatotossiċità relatata mal-immunità, urew evidenza ta' infjammazzjoni akuta (newtrofili, limfoċiti, u makrofaġi).
English: Musculoskeletal and connective tissue disorders Common arthralgia, myalgia, musculoskeletal painf, muscle spasms Uncommon polymyalgia rheumatica, myositisd, arthritis, muscular weaknessd Rare polymyositisd Renal and urinary disorders Uncommon renal failureb, glomerulonephritisc, autoimmune nephritisd, renal tubular acidosis, haematuriad
Maltese: Mhux komuni polimijalġja rewmatika, mijożited, artrite, dgħufija muskularid Rari polimijożited Disturbi fil-kliewi u fis-sistema urinarja Mhux komuni insuffiċjenza tal-kliewib, glomerulonefriteċ, nefrite awtoimmunid, aċidożi tubulari talkliewi, ematurjad
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 2.8% for anaemia (all Grade 3), 1.2% for thrombocytopaenia, 0.5% for leucopoenia, 6.7% for lymphopaenia, 0.7% for neutropaenia, 4.3% for increased alkaline phosphatase, 12.4% for increased AST, 15.3% for increased ALT, 1.2% for increased total bilirubin, 2.4% for increased creatinine, 5.3% for hyperglycaemia, 8.7% for increased amylase, 19.5% for increased lipase, 1.2% for hypocalcaemia, 0.2% each for hypernatraemia and hypercalcaemia, 0.5% for hyperkalemia, 0.3% for hypermagnesaemia, 4.8% for hypokalaemia, and 9.5% for hyponatraemia.
Maltese: 3% għal żieda fl-ALT, 1.2% għal żieda filbilirubina totali, 2.4% għal żieda fil-kreatinina, 5.3% għal ipergliċemija, 8.7% għal żieda fl-amilażi, 19.5% għal żieda fil-lipażi, 1.2% għal ipokalċemija, 0.2% kull wieħed għal ipernatremija u iperkalċemija, 0.5% għal iperkalimja, 0.3% għal ipermagnesemija, 4.8% għal ipokalemija, u 9.5% għal iponatremija.
English: Efficacy by BRAF status: After18 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to ipilimumab in combination with nivolumab had a median PFS of 15.5 months (95% CI: 8.0, NA) and 11.3 months (95% CI: 8.3, 22.2), while those in the nivolumab monotherapy arm had a median PFS of 5.6 months (95% CI: 2.8, 9.3) and 7.1 months (95% CI: 4.9, 14.3), respectively.
Maltese: Wara 18-il xahar ta' follow up, pazjenti pożittivi għall-mutazzjoni BRAF[V600] u b'BRAF tat-tip selvaġġ li ġew randomizzati għal ipilimumab flimkien ma' nivolumab kellhom PFS medjana ta' 15.5 xhur (95% CI: 8.0, NA) u 11.3 xhur (95% CI: 8.3, 22.2), filwaqt li dawk fil-fergħa ta' monoterapija b'nivolumab kellhom PFS medjana ta' 5.6 xhur(95% CI: 2.8, 9.3) u 7.1 xhur (95% CI: 4.9, 14.3), rispettivament.
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).
Maltese: YERVOY f'kombinazzjoni ma' nivolumab huwa indikat għall-kura tal-ewwel linja ta' pazjenti adulti b'karċinoma avvanzata taċ-ċelloli tal-kliewi b'riskju intermedju/baxx (ara sezzjoni 5.1).
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.
Maltese: Ġew irrappurtati każijiet ta' Grad 2, Grad 3, u Grad 4 f'1.6% (7/448), 0.9% (4/448), u 0.7% (3/448) tal-pazjenti, rispettivament.
English: Grade 2 hypopituitarism occurred in 0.4% (2/547) of patients.
Maltese: Ipopitwitariżmu tal-Grad 2 seħħ f'0.4 % (2/547) tal-pazjenti.
English: Patients ≥ 75 years of age represented 8% of all intermediate/poor risk patients in CA209214, and the combination of ipilimumab with nivolumab showed numerically less effect on OS (HR 0.97, 95% CI: 0.48, 1.95) in this subgroup versus the overall population.
Maltese: Pazjenti ta' ≥ 75 sena kienu jirrappreżentaw 8% tal-pazjenti kollha b'riskju intermedju/fqir f'CA209214, u l-kombinazzjoni ta' ipilimumab ma' nivolumab wriet inqas effett numeriku fuq l-OS (HR 0.97, 95% CI: 0.48, 1.95) f'dan is-sottogrupp meta mqabbel mal-popolazzjoni ġenerali.
English: In the ipilimumab 10 mg/kg group, the median OS (95% CI) was 16 months (11.63, 17.84) and in the ipilimumab 3 mg/kg group the median OS (95% CI) was 12 months (9.86, 13.27).
Maltese: Filgrupp ta' ipilimumab 10 mg/kg, l-OS medjana (95% CI) kienet ta' 16-il xahar (11.63, 17.84) u filgrupp ta' ipilimumab 3 mg/kg l-OS medjana (95% CI) kienet ta' 12-il xahar (9.86, 13.27).
English: Median time to onset was 2.6 months (range: 0.25-20.6).
Maltese: Iż-żmien medjan għall-bidu kien ta' 2.6 xhur (medda: 0.25-20.6).
English: Common stomatitis, pancreatitis, constipation, dry mouth colitis, stomatitis, pancreatitis, abdominal pain, constipation, dry mouth
Maltese: Komuni stomatite, pankreatite, stitikezza, ħalq xott kolite, stomatite, pankreatite, uġigħ flistonku, stitikezza, ħalq xott
English: It contains 2.3 mg sodium per ml of concentrate.
Maltese: Din il-mediċina fiha 2.3 mg ta' sodium għal kull ml ta' konċentrat.
English: OS at 1 year % (95% CI) OS at 2 years % (95% CI)
Maltese: OS wara sena % (95% CI) OS wara sentejn % (95% CI)
English: Each vial contains 200 mg ipilimumab.
Maltese: Kull kunjett fih 200 mg ta' ipilimumab.
English: For Grade 2 (symptomatic) pneumonitis, ipilimumab in combination with nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Maltese: Għal pulmonite ta' Grad 2 (sintomatika), ipilimumab flimkien ma' nivolumab għandu jitwaqqaf, u għandhom jinbdew il-kortikosterojdi b'doża ta' 1 mg/kg/jum ta' ekwivalenti għal methylprednisolone.
English: The chemical and physical in-use stability of the undiluted or diluted concentrate (between 1 and 4 mg/ml) has been demonstrated for 24 hrs at 25°C and 2°C to 8°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu tal-konċentrat mhux dilwit jew dilwit (bejn 1 u 4 mg/ml) intweriet għal 24 siegħa f'temperatura ta' 25°C u 2°C sa 8°C.
English: Ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg
Maltese: Ipilimumab 3 mg/kg flimkien ma' nivolumab 1 mg/kg
English: Strata adjusted difference.
Maltese: Differenza aġġustata għall-istrati.
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.
Maltese: Meta ipilimumab 3 mg/kg ingħata flimkien ma' nivolumab 1 mg/kg, is-CL ta' ipilimumab żdied b'9 % u s-CL ta' nivolumab żdied b'29 %, liema tibdil ma kienx ikkunsidrat klinikament rilevanti.
English: Months (range)
Maltese: Żmien (xhur)
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).
Maltese: F'pazjenti li kienu qed jingħataw kura b'ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg f'RCC, l-inċidenza ta' dijarea jew ta' kolite kienet ta' 28.2% (154/547).
English: Subsequent systemic therapy was received by 31.8%, 44.3%, and 62.2% of patients in the combination, nivolumab monotherapy, and ipilimumab arms, respectively.
Maltese: L-analiżi ta' OS ma ġietx aġġustata sabiex tikkunsidra terapiji sussegwenti li ngħataw. Ġiet riċevuta terapija sistemika sussegwenti minn 31.8%, 44.3%, u 62.2% tal-pazjenti fil-fergħat tal-kombinazzjoni, monoterapija b'nivolumab u ipilimumab, rispettivament.
English: - Inflammation of the muscles such as myocarditis (inflammation of the heart muscle), myositis (inflammation of the muscles) and rhabdomyolysis (stiffness in muscles and joints, muscle spasm).
Maltese: - Infjammazzjoni tal-muskoli bħal mijokardite (infjammazzjoni tal-muskolu tal-qalb), mijożite (infjammazzjoni tal-muskoli) u rabdomijoliżi (ebusija fil-muskoli u l-ġogi, spażmu fil-muskoli).
English: Renal Cell Carcinoma (RCC)
Maltese: Karċinoma taċ-Ċelloli tal-Kliewi (RCC)
English: These additional reactions occurred at a frequency of < 1% unless otherwise noted: meningism, myocarditis, pericardial effusion, cardiomyopathy, autoimmune hepatitis, erythema nodosum, autoimmune pancreatitis, hyperpituitarism, hypoparathyroidism, infectious peritonitis, episcleritis, scleritis, Raynaud's phenomenon, palmar-plantar erythrodysaesthesia syndrome, cytokine release syndrome, sarcoidosis,
Maltese: Dawn ir-reazzjonijiet addizzjonali seħħew bi frekwenza ta' < 1% għajr meta nnutat mod ieħor: meninġiżmu, mijokardite, effużjoni perkardjali, kardjomijopatija, epatite awtoimmuni, eritema nodosum, pankreatite awtoimmuni, iperpitwitariżmu, ipoparatirojdiżmu, peritonite infettiva, episklerite, sklerite, ilfenomenu ta' Raynaud, sindromu ta' eritrodisastesija palmar-plantar, sindrome ta' ħruġ ta' cytokines, sarkojdożi, tnaqqis ta' gonadotrophin fid-demm, lewkopenija, poliċitemija, limfoċitożi, mijożite okulari u ipoakużi newrosensorjali.
English: Liver function tests (LFTs) and thyroid function tests should be evaluated at baseline and before each dose of YERVOY.
Maltese: Testijiet tal-funzjoni tal-fwied (LFTs - liver function tests) u testijiet tal-funzjoni tat-tirojde għandhom jiġu evalwati fil-linja bażi u qabel kull doża ta' YERVOY.
English: Persistent diarrhoea or colitis should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Maltese: Dijarea jew kolite persistenti għandha tiġi mmaniġġjata b'kortikosterojdi b'doża ta' 0.5 sa 1 mg/kg/jum ta' ekwivalenti għal methylprednisolone.
English: Uncommon spondyloarthropathy, Sjogren's syndrome, arthritis, myopathy, myositis (including polymyositis)a,e, rhabdomyolysisa,f polymyalgia rheumatica, myositis (including polymyositis), rhabdomyolysis
Maltese: Mhux komuni spondiloartropatija, is-sindrome ta' Sjogren, artrite, mijopatija, mijożite (inkluż polimijożite)a,e, rabdomajoliżia,f polimijalġija rewmatika, mijożite (inkluż polimijożite), rabdomajoliżi
English: The primary efficacy population included those intermediate/poor risk patients with at least 1 or more of 6 prognostic risk factors as per the International Metastatic RCC Database Consortium (IMDC) criteria (less than one year from time of initial renal cell carcinoma diagnosis to randomisation, Karnofsky performance status <80%, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dL, platelet count greater than the upper limit of normal, and absolute neutrophil count greater than the upper limit of normal).
Maltese: Il-popolazzjoni tal-effikaċja primarja kienet tinkludi dawk il-pazjenti b'riskju intermedjarju/fqir b'talanqas fattur ta' riskju pronjostiku wieħed jew aktar minn sitta skont il-kriterji tal-Konsorzju tal-Bażi tad-Data ta' RCC Metastatika (IMDC) (inqas minn sena miż-żmien taddijanjożi inizjali ta' karċinoma taċ-ċelloli tal-kliewi għar-randomizzazzjoni, status ta' prestazzjoni ta' Karnofsky <80%, emoglobina inqas mill-aktar limitu baxx tan-normal, kalċju kkoreġut ta' iktar minn 10 mg/dL, għadd ta' plejtlits ikbar mil-limitu ta' fuq tan-normal, u għadd assolut ta' newtrofili akbar mil-limitu ta' fuq tan-normal).
English: Fatal hepatic failure has been reported in clinical trials (see section 4.8).
Maltese: Insuffiċjenza fatali tal-fwied ġiet irrapportata fil-provi kliniċi (ara sezzjoni 4.8).
English: No Grade 3-5 cases were reported.
Maltese: Ma ġie rrappurtat l-ebda każ ta' Grad 3-5.
English: Abnormal liver function tests (increased amounts of the liver enzymes aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase in your blood, higher blood levels of the waste product bilirubin)
Maltese: Testijiet anormali tal-funzjoni tal-fwied (żieda fl-ammonti tal-enzimi tal-fwied aspartate aminotransferase, alanine aminotransferase jew fosfatażi alkalina fid-demm tiegħek, livelli ogħla ta' bilirubina fid-demm)
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.
Maltese: Meta ipilimumab 1 mg/kg ingħata f'kombinazzjoni ma' nivolumab 3 mg/kg, is-CL ta' ipilimumab naqqset b'1.5% u s-CL ta' nivolumab żdiedet b'1%, liema tibdil ma kienx ikkunsidrat klinikament rilevanti.
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).
Maltese: Għall-espressjoni PD-L1 tat-tumur < 1%, l-OS medjana kienet ta' 34.7 xhur għall-fergħa ta' ipilimumab f'kombinazzjoni ma' nivolumab u ta' 32.2 xahar fil-fergħa ta' sunitinib (HR = 0.70; 95% CI: 0.54, 0.92).
English: YERVOY can be used for intravenous administration without dilution or may be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection to concentrations between 1 and 4 mg/ml.
Maltese: YERVOY jista' jintuża għall-għoti ġol-vini mingħajr dilwizzjoni jew jista' jiġi dilwit f'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni jew glucose 50 mg/ml (5%) soluzzjoni għallinjezzjoni għal konċentrazzjonijiet bejn 1 u 4 mg/ml.
English: Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).
Maltese: Relattiva għal monoterapija b'nivolumab, żieda fis-sopravivenza mingħajr progressjoni (PFS) u fissopravivenza globali (OS) għall-kombinazzjoni ta' nivolumab ma' ipilimumab hija stabbilita biss f'pazjenti b'espressjoni baxxa ta' PD-L1 tat-tumur (ara sezzjonijiet 4.4 u 5.1).
English: Grade 1, Grade 2, Grade 3, and Grade 4 diabetes mellitus and Grade 4 diabetic ketoacidosis were each reported in 0.2% (1/448) of patients.
Maltese: Dijabete mellitus ta' Grad 1, Grad 2, Grad 3 u Grad 4 u ketoaċidożi dijabetika ta' Grad 4 ġew irrappurtati kull wieħed f' 0.2% (1/448) tal-pazjenti.
English: Clinical trials with ipilimumab in combination with nivolumab Melanoma
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Ipilimumab must be permanently discontinued in patients with a very severe (Grade 4) rash or severe (Grade 3) pruritus (see section 4.2), and systemic high-dose intravenous corticosteroid therapy (e.g. methylprednisolone 2 mg/kg/day) should be initiated immediately.
Maltese: Ipilimumab għandu jitwaqqaf b'mod permanenti f'pazjenti b'raxx sever ħafna (Grad 4) jew ħakk sever (Grad 3) (ara sezzjoni 4.2), u għandha tinbeda minnufih terapija b'doża għolja sistemika ta' kortikosterojde ġol-vina (eż. methylprednisolone 2 mg/kg/kuljum).
English: • Brief introduction to ipilimumab (and the purpose of this risk minimisation tool).
Maltese: • Introduzzjoni qasira għal ipilimumab (u l-għan ta' din l-għodda ta' minimizzazzjoni tar-riskju).
English: The following adverse reactions suspected to be immune-related have been reported in patients treated with ipilimumab 3 mg/kg monotherapy in MDX010-20: uveitis, eosinophilia, lipase elevation, and glomerulonephritis.
Maltese: Ir-reazzjonijiet avversi li ġejjin, li huma ssuspettati li huma relatati mal-immunità, ġew irrapportati f'pazjenti kkurati b' ipilimumab 3 mg/kg mogħti waħdu fi studju MDX010-20: uveite, eosinofilija, żieda f'lipase, u glomerulonefrite.
English: Rate (95% CI) At 6 months At 12 months Progression-free survival Events
Maltese: Rata (CI ta' 95%) Wara 6 xhur Wara 12-il xahar Sopravivenza mingħajr progressjoni Avvenimenti Proporzjon ta' periklua
English: CL was not affected by age (range 23-88 years), gender, concomitant use of budesonide or dacarbazine, performance status, HLA-A2*0201 status, mild hepatic impairment, renal impairment,
Maltese: Is-CL ma kinitx affettwa mill-età (medda 23-88 sena), mis-sess, mill-użu konkomitanti ta' budesonide jew ta' dacarbazine, mill-istatus tal-prestazzjoni, mill-istatus talHLA-A2*0201, minn indeboliment epatiku ħafif, minn indeboliment tal-kliewi, minn immunoġeniċità, u minn terapija preċedenti kontra l-kanċer.