FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 3 diarrhoea or colitis observed with ipilimumab in combination with nivolumab requires permanent discontinuation of treatment and initiation of corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Dijarea jew kolite ta' Grad 3 osservata b'ipilimumab flimkien ma' nivolumab teħtieġ twaqqif permanenti tal-kura u l-bidu tal-kortikosterojdi b'doża ta' 1 sa 2 mg/kg/jum ta' ekwivalenti għal methylprednisolone.
English: In intermediate/poor-risk patients, OS benefit was observed in the ipilimumab in combination with nivolumab arm vs. sunitinib regardless of tumour PD-L1 expression.
Maltese: F'pazjenti b'riskju intermedju/fqir, il-benefiċċju tal-OS kien osservat fil-fergħa ta' ipilimumab f'kombinazzjoni ma' nivolumab kontra sunitinib irrispettivament mill-espressjoni PD-L1 tat-tumur.
English: Each 10 ml vial of YERVOY concentrate provides 50 mg of ipilimumab; each 40 ml vial provides 200 mg of ipilimumab.
Maltese: Kull kunjett ta' 10 ml ta' YERVOY jipprovdi 50 mg ta' ipilimumab; kull kunjett ta' 40 ml jipprovdi 200 mg ta' ipilimumab.
English: One 10 ml vial contains 50 mg of ipilimumab.
Maltese: Kull kunjett ta' 10 ml fih 50 mg ta' ipilimumab.
English: The volume of YERVOY concentrate to prepare the dose (ml) = the total dose in mg, divided by 5 (the YERVOY concentrate strength is 5 mg/ml).
Maltese: Il-volum ta' konċentrat ta' YERVOY biex tipprepara d-doża (ml) = id-doża totali f'mg, diviża b'5 (il-qawwa ta' konċentrat ta' YERVOY hi ta' 5 mg/ml).
English: • Placeholder including the weblink of the Package Leaflet on the EMA website
Maltese: • ‘Placeholder' inkluż il-weblink tal-Fuljett ta' Tagħrif fuq is-sit elettroniku tal-EMA.
English: Upon improvement, ipilimumab may be resumed (see section 4.2).
Maltese: Meta jkun hemm titjib, ipilimumab jista' jitkompla (ara sezzjoni 4.2).
English: Severe hepatitis has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Maltese: Ġiet osservata epatite severa b'ipilimumab flimkien ma' nivolumab (ara sezzjoni 4.8).
English: Among patients with quantifiable tumour PD-L1 expression, the distribution of patients was balanced across the three treatment groups.
Maltese: Fost il-pazjenti b'espressjoni ta' PD-L1 tat-tumur kwantifikabbli, id-distribuzzjoni ta' pazjenti kienet ibbilanċjata fost it-tliet gruppi ta' kura.
English: Patients should be monitored for signs and symptoms of pneumonitis such as radiographic changes (e.g., focal ground glass opacities, patchy filtrates), dyspnoea, and hypoxia.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' pulmonite bħal tibdil radjografiku (eż., opaċitajiet fokali tal-“ground glass”, filtrati irregolari), dispnea u ipoksja.
English: YERVOY as monotherapy Melanoma
Maltese: YERVOY flimkien ma' nivolumab Melanoma
English: Symptomatic treatment (e.g. loperamide, fluid replacement) and close monitoring are advised.
Maltese: Kura għas-sintomi (eż. loperamide, sostituzzjoni ta' fluwidu) u monitoraġġ mill-qrib huma rakkomandati.
English: For additional information on clinical efficacy and safety associated with the dosing recommendations of nivolumab when administered as monotherapy following combination therapy with ipilimumab, please refer to the nivolumab SmPC.
Maltese: Għal informazzjoni addizzjonali dwar l-effikaċja klinika u sigurtà assoċjati mar-rakkomandazzjonijiet tad-dożaġġ ta' nivolumab meta jingħata bħala monoterapija wara terapija kombinata b'ipilimumab, jekk jogħġbok irreferi għall-SmPC ta' nivolumab.
English: Time to onset of moderate to severe or fatal (Grade 2 to 5) immune-related hepatotoxicity ranged from 3 to 9 weeks from the start of treatment.
Maltese: Iż-żmien għal bidu ta' epatotossiċità moderata sa severa jew fatali (Grad 2 sa 5) relatata mal-immunità varja minn 3 sa 9 ġimgħat mill-bidu tal-kura.
English: ipilimumab Median OS (95% CI)
Maltese: ipilimumab OS medjana (95 % CI)
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.
Maltese: F'pazjenti li rċivew 3 mg/kg ta' ipilimumab waħda fl-istudju MDX010-20, l-iktar reazzjonijiet avversi li kienu rrapportati b'mod frekwenti (≥ 10% tal-pazjenti) kienu dijarea, raxx, ħakk, għeja, nawseja, rimettar, nuqqas t'aptit, u wġigħ addominali.
English: In a Phase 2 trial, the sequential treatment with vemurafenib followed by 10 mg/kg ipilimumab in patients with BRAF-mutated metastatic melanoma showed a higher incidence of Grade 3+ skin adverse reactions than with ipilimumab alone.
Maltese: Fi prova ta' Fażi 2, il-kura sekwenzjali ma' vemurafenib segwita minn 10 mg/kg ipilimumab f'pazjenti b'melanoma metastatika ta' mutazzjoni BRAF uriet inċidenza ogħla ta' reazzjonijiet avversi tal-ġilda ta' Grad 3+ milli b'ipilimumab waħdu.
English: Since gastrointestinal haemorrhage is an adverse reaction with ipilimumab (see section 4.8), patients who require concomitant anticoagulant therapy should be monitored closely.
Maltese: Minħabba li lemorraġija gastrointestinali hija reazzjoni avversa ma' ipilimumab (ara sezzjoni 4.8), pazjenti li jeħtieġu terapija konkomitanti b'antikoagulanti għandhom jiġu mmonitorjati mill-qrib.
English: Uncommon haemolytic anaemiab, thrombocytopenia, eosinophilia, neutropenia Not known histiocytosis haematophagice
Maltese: Kwalunkwe reazzjonijiet avversi oħra tas-sistema tal-organi li huma relatati mal-immunità għandhom tiġu kklassifikati skont CTCAE.
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.
Maltese: Għal żieda ta' Grad 3 jew 4 fit-transaminase jew fil-bilirubina totali, ipilimumab flimkien ma' nivolumab għandu jitwaqqaf b'mod permanenti, u għandhom jinbdew il-kortikosterojdi b'doża ta' 1 sa 2 mg/kg/jum ta' ekwivalenti għal methylprednisolone.
English: Nivolumab + ipilimumab (events: 166/425), median and 95.0% CI: NA (32.49, NA)
Maltese: Nivolumab+Ipilimumab (avvenimenti: 59/123), medjan u 95% CI: N.A.
English: Severe rash should be managed with high-dose corticosteroid at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Maltese: Raxx sever għandu jiġi mmaniġġjat b'kortikosterojdi ta' doża għolja b'doża ta' 1 sa 2 mg/kg/jum ta' ekwivalenti għal methylprednisolone.
English: A group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour lysis syndrome) An inflammatory disorder (most likely of autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt-Koyanagi-Harada syndrome) Inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial disorders)
Maltese: Grupp ta' kumplikazzjonijiet metaboliċi li jseħħu wara kura għall-kanċer ikkaratterizzati minn livelli għoljin ta' potassju u ta' fosfat, u livelli baxxi ta' kalċju fid-demm (is-sindrome tal-liżi ta' tumur)
English: In clinical trials, immune-related colitis was associated with evidence of mucosal inflammation, with or without ulcerations, and lymphocytic and neutrophilic infiltration.
Maltese: Fil-provi kliniċi, kolite relatata mal-immunità ġiet assoċjata ma' evidenza ta' infjammazzjoni tal-mukuża, bi jew mingħajr ulċerazzjonijiet, u infiltrazzjoni limfoċitika u newtrofilika.
English: Patients should be monitored for cardiac and pulmonary adverse reactions continuously, as well as for clinical signs, symptoms, and laboratory abnormalities indicative of electrolyte disturbances and dehydration prior to and periodically during treatment.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal reazzjonijiet avversi kardijaċi u pulmonari b'mod kontinwu, kif ukoll għal sinjali kliniċi, sintomi u anormalitajiet tal-laboratorju li jindikaw disturbi tal-elettroliti u deidratazzjoni qabel u perjodikament waqt il-kura.
English: Immune-related colitis Ipilimumab in combination with nivolumab
Maltese: Kolite relatata mal-immunità Ipilimumab flimkien ma' nivolumab
English: For patients with Grade 3 or 4 transaminase or total bilirubin elevation, treatment must be permanently discontinued (see section 4.2), and systemic high-dose intravenous corticosteroid therapy (e.g. methylprednisolone 2 mg/kg daily or equivalent) should be initiated immediately.
Maltese: Għal pazjenti bi transaminase ta' Grad 3 jew 4 jew b'żieda fil-bilirubina totali, il-kura għandha titwaqqaf b'mod permanenti (ara sezzjoni 4.2), u għandha tinbeda minnufih terapija b'doża għolja ta' kortikosterojde ġol-vina sistemika (eż. methylprednisolone 2 mg/kg kuljum jew ekwivalenti).
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.
Maltese: Likwidu ċar sa kemmxejn opalexxenti, bla kulur sa isfar ċar li jista' jkollu xi (ftit) frak ħafif u għandu pH ta' 7.0 u osmolarità ta' 260-300 mOsm/kg.
English: The recommended induction regimen of YERVOY is 3 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of 4 doses.
Maltese: Il-kors rakkomandat ta' induzzjoni ta' YERVOY hu ta' 3 mg/kg mogħti ġol-vina fuq perjodu ta' 90 minuta kull 3 ġimgħat għal total ta' 4 dożi.
English: Ipilimumab in combination with nivolumab is used to treat advanced melanoma (a type of skin cancer) in adults advanced renal cell carcinoma (advanced kidney cancer) in adults
Maltese: Ipilimumab f'kombinazzjoni ma' nivolumab jintuża għall-kura ta' melanoma avvanzata (tip ta' kanċer tal-ġilda) fl-adulti karċinoma avvanzata taċ-ċelloli tal-kliewi (kanċer avvanzat tal-kliewi) fl-adulti
English: - inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis, Stevens-Johnson syndrome and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
Maltese: - infjammazzjoni tal-ġilda li tista' twassal għal reazzjoni severa tal-ġilda (magħrufa bħala nekroliżi epidermali tossika, sindromu ta' Stevens-Johnson u Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi, DRESS).
English: Study CA184178 was a non-randomized, multicenter, open-label Phase 2 study, in adolescent patients 12 to < 18 years of age with previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma.
Maltese: L-istudju CA184178 kien studju mhux randomizzat, b'ħafna ċentri, bit-tikketta mikxufa ta' Fażi 2, f'pazjenti adolexxenti minn 12 sa < 18 ‘il sena b'melanoma malinna tal-Istadju III jew tal-Istadju IV li ma tistax tinqata ikkurata jew mhux ikkurata qabel.
English: Time to onset of moderate to very severe (Grade 2 to 4) immune-related endocrinopathy ranged from 7 to nearly 20 weeks from the start of treatment.
Maltese: Iż-żmien għal bidu ta' endokronopatija moderata sa severa ħafna (Grad 2 sa 4) relatata mal-immunità varja minn 7 sa kważi 20 ġimgħa millbidu tal-kura.
English: Thereafter the recommended dose of nivolumab is 240 mg given every 2 weeks or 480 mg given every 4 weeks (single-agent phase).
Maltese: Wara dan, id-doża rakkomandata ta' nivolumab hija ta' 240 mg li tingħata kull ġimgħatejn jew ta' 480 mg li tingħata kull 4 ġimgħat (fażi b'sustanza waħda).
English: OS results at an additional analysis undertaken at a minimum follow-up of 36 months show outcomes consistent with the original analysis.
Maltese: Ir-riżultati ta' OS f'analiżi addizzjonali li saret b'follow-up minimu ta' 36 xahar juru riżultati konsistenti malanaliżi oriġinali.
English: Grade 2 and Grade 3 hypopituitarism occurred in 0.4% (2/448) and 0.7% (3/448) of patients, respectively.
Maltese: Ipopitwitariżmu ta' Grad 2 u Grad 3 seħħ f'0.4% (2/448) u 0.7% (3/448) tal-pazjenti, rispettivament.
English: In the ipilimumab 3 mg/kg monotherapy group, rash and pruritus of any severity were each reported in 26% of patients.
Maltese: Fil-grupp li ngħata ipilimumab 3 mg/kg waħdu, raxx u ħakk ta' kwalunkwe severità ġew irrapportati f'26% tal-pazjenti kull wieħed.
English: For patients who required re-treatment, the BORR was 38% (3/8 patients) in the ipilimumab monotherapy group, and 0% in the gp100 group.
Maltese: Għal pazjenti li kienu jeħtieġu terapija ta' kura mill-ġdid, il-BORR kien ta' 38% (3/8 pazjenti) filgrupp ta' ipilimumab mogħti waħdu, u 0% fil-grupp ta' gp100.
English: * ipilimumab in combination with nivolumab for the first 4 doses then followed by nivolumab monotherapy in melanoma.
Maltese: * ipilimumab flimkien ma' nivolumab għall-ewwel 4 dożi mbagħad segwit minn monoterapija b'nivolumab fil-melanoma.
English: Immune-related nephritis and renal dysfunction
Maltese: Nefrite u disfunzjoni tal-kliewi relatata mal-immunità
English: The median age was 61 years (range: 18 to 90 years), 65% of patients were men, and 97% were white.
Maltese: L-età medjana kienet 61 sena (medda: 18 sa 90 sena), 65% tal-pazjenti kienu rġiel, u 97% kienu bojod.
English: Based on an exposure-response analysis in 497 patients with advanced melanoma, OS was independent of prior systemic anti-cancer therapy and increased with higher ipilimumab Cminss plasma concentrations.
Maltese: Skont l-analiżi dwar ir-rispons mill-esponiment f'497 pazjent b'melanoma avvanzata, l-OS kien indipendenti mit-terapija sistemika li ngħatat qabel ta' kontra l-kanċer u żdied b'konċentrazzjonijiet ogħla Cminss ta' ipilimumab fil-plażma.
English: If resolution to Grades 0-1 or return to baseline occurs, ipilimumab may be resumed (see section 4.2).
Maltese: Jekk iseħħ il-fejqan għal Gradi 0-1 jew ikun hemm ritorn għal-linja bażi, ipilimumab jista' jitkompla (ara sezzjoni 4.2).
English: If myocarditis is suspected, prompt initiation of a high dose of steroids (prednisone 1 to 2 mg/kg/day or methylprednisolone 1 to 2 mg/kg/day) and prompt cardiology consultation with diagnostic workup according to current clinical guidelines should be initiated.
Maltese: Jekk ikun hemm suspett ta' mijokardite, għandha tinbeda fil-pront doża għolja ta' sterojdi (prednisone 1 sa 2 mg/kg/kuljum jew methylprednisolone 1 sa 2 mg/kg/kuljum) u għandha tinbeda konsultazzjoni kardjoloġika fil-pront b'workup dijanjostiku skont il-linji gwidi kliniċi attwali.
English: The majority had received all 4 doses during induction.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Sensory neuropathy may also occur.
Maltese: Newropatija sensorjali tista' sseħħ ukoll.
English: Symptomatic Grade 2 or 3 hypothyroidism, hyperthyroidism, hypophysitis,
Maltese: Ipotirojdiżmu, ipertirojdiżmu, ipofiżite sintomatika ta' Grad 2 jew 3,
English: Immune-related hepatotoxicity
Maltese: Pulmonite relatata mal-immunità
English: Persistent elevations in these laboratory values should be managed with corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Maltese: Żidiet persistenti f'dawn valuri tal-laboratorju għandhom jiġu mmaniġjati bilkortikosterojdi b'doża ta' 0.5 sa 1 mg/kg/jum ta' ekwivalenti għal methylprednisolone.
English: Median time to onset was 1.2 months (range: 0.0-24.7).
Maltese: Iż-żmien medjan għall-bidu kien ta' 1.2 xhur (medda: 0.0-24.7).
English: NAME OF THE MEDICINAL PRODUCT YERVOY 5 mg/ml concentrate for solution for infusion 2.
Maltese: YERVOY 5 mg/ml konċentrat għal soluzzjoni għall-infużjoni 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.
Maltese: Għal pulmonite ta' Grad 3 jew 4, ipilimumab flimkien ma' nivolumab għandu jitwaqqaf b'mod permanenti, u għandhom jinbdew il-kortikosterojdi b'doża ta' 2 sa 4 mg/kg/jum ta' ekwivalenti għal methylprednisolone.
English: Severe rash has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Maltese: Ġie osservat raxx sever b'ipilimumab flimkien ma' nivolumab (ara sezzjoni 4.8).
English: Common dehydration dehydration
Maltese: Komuni deidratazzjoni deidratazzjoni
English: Secretion of IgGs in human milk is generally limited and IgGs have a low oral bioavailability.
Maltese: Issekrezzjoni ta' IgGs fil-ħalib uman huwa ġeneralment limitat u IgGs għandhom bijodisponibbiltà orali baxxa.
English: After 28 months of follow-up, BRAF[V600] mutation-positive and BRAF wild-type patients randomised to ipilimumab in combination with nivolumab had an ORR of 67.6% (95% CI: 57.7, 76.6; n = 102) and 54.7% (95% CI: 47.8, 61.5; n = 212), while those in the nivolumab monotherapy arm had an ORR of 36.7% (95% CI: 27.2, 47.1; n = 98) and 48.2% (95% CI: 41.4, 55.0; n = 218), respectively.
Maltese: Wara 28 xahar ta' follow up, pazjenti pożittivi għallmutazzjoni BRAF[V600] u b'BRAF tat-tip selvaġġ li ġew randomizzati għal ipilimumab flimkien ma' nivolumab kellhom ORR ta' 67.6% (95% CI: 57.7, 76.6; n = 102) u 54.7% (95% CI: 47.
English: Hepatic transaminase and bilirubin must be evaluated before each dose of ipilimumab, as early laboratory changes may be indicative of emerging immune-related hepatitis (see section 4.2).
Maltese: Il-livelli ta' transaminase u bilirubina fil-fwied għandhom jiġu evalwati qabel kull doża ta' ipilimumab, għax tibdil bikri fir-riżultati tal-laboratorju jista' jkun indikattiv ta' epatite emerġenti relatata mal-immunità (ara sezzjoni 4.2).
English: Severe nephritis and renal dysfunction have been observed with ipilimumab in combination with nivolumab (see section 4.8).
Maltese: Dijarea severa jew kolite ġiet osservat b'ipilimumab f'kombinazzjoni ma' nivolumab (ara sezzjoni 4.8).
English: Not known pemphigoid
Maltese: Indeboliment tal-fwied
English: Among 131 patients who discontinued the combination due to adverse reaction after 28 months of follow-up, the ORR was 71% (93/131) with 20% (26/131) achieving a complete response and median OS was not reached.
Maltese: Fost il-131 pazjent li waqqfu l-kombinazzjoni minħabba reazzjoni avversa wara 28 xahar ta' follow-up, l-ORR kienet 71% (93/131) b'20% (26/131) li kisbu rispons komplet u l-OS medjana ma ntlaħqitx.
English: Data presented in those sections primarily reflect experience from a Phase 3 study, MDX010-20.
Maltese: Dejta ppreżentata f'dawk is-sezzjonijiet primarjament tirrifletti l-esperjenza minn studju ta' Fażi 3, MDX010-20.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 5 mg ipilimumab.
Maltese: Kull millilitru ta' konċentrat fih 5 mg ta' ipilimumab.
English: Hypersensitivity/Infusion Reaction a at least 40 mg daily prednisone equivalents b frequency is based on the number of patients who experienced the immune-related adverse reaction
Maltese: Sensittività eċċessiva/Reazzjoni għallInfużjoni a tal-inqas 40 mg kuljum ta' ekwivalenti għal prednisone b il-frekwenza hija bbażata fuq in-numru ta' pazjenti li esperjenza ir-reazzjoni avversa relatata mal-immunità
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
Maltese: Il-medja (koeffiċjent perċentwali ta' varjazzjoni) -ta' ipilimumab -Cmin li nkisbet fl-istat fiss b'kors ta' induzzjoni ta' 3 mg/kg kienet ta' 19.4 μg/ml (74.6%).
English: CTLA-4 blockade can also reduce T-regulatory cell function, which may contribute to an anti-tumour immune response.
Maltese: L-imblukkar ta' CTLA-4 jista' jnaqqas ukoll il-funzjoni taċ-ċellula regolatorja T, u dan jista' jikkontribwixxi għal rispons immuni kontra t-tumuri.
English: Resolution occurred in 191 patients (65.9%) with a median time to resolution of 11.4 weeks (range: 0.1-150.1+).
Maltese: Il-fejqan seħħ f'191 pazjent (65.9%) bi żmien medjan għal fejqan ta' 11.4 ġimgħat (medda: 0.1-150.1+).
English: Life threatening skin rash (including Stevens-Johnson syndrome or toxic epidermal necrolysis) or severe widespread pruritus interfering with activities of daily living or requiring medical intervention
Maltese: Raxx tal-ġilda ta' periklu għall-ħajja (li jinkludi s-sindrome ta' Stevens-Johnson jew nekrolisi epidermali tossika) jew ħakk mifrux sever li jinterferixxi mal-attivitajiet tal-ħajja ta' kuljum jew li jkunu jeħtieġu intervent mediku
English: Rare cases of SJS and TEN some of them with fatal outcome have been observed (see sections 4.2 and 4.4).
Maltese: Ġew osservati każijiet rari ta' SJS u TEN li xi wħud minnhom kienu b'riżultat fatali (ara sezzjonijiet 4.2 u 4.4).
English: Renal impairment
Maltese: reazzjoni marbuta mal-infużjoni
English: Check with your doctor or nurse before you are given YERVOY if you have an autoimmune disease (a condition where the body attacks its own cells); if you have, or have ever had, chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV); if you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS).
Maltese: Iċċekkja mat-tabib jew mal-infermier tiegħek qabel ma tingħata YERVOY jekk għandek marda awtoimmuni (kundizzjoni fejn il-ġisem jattakka liċ-ċelluli tiegħu stess); jekk għandek, jew xi darba kellek, infezzjoni virali kronika tal-fwied, inklużi l-epatite B (HBV) jew l-epatite Ċ (HCV);
English: Ipilimumab in combination with nivolumab should be discontinued for life-threatening or recurrent severe cardiac and pulmonary adverse reactions (see section 4.2).
Maltese: Ipilimumab f'kombinazzjoni ma' nivolumab għandu jitwaqqaf f'każ ta' reazzjonijiet avversi kardijaċi u pulmonari ta' periklu għall-ħajja jew severi rikorrenti (ara sezzjoni 4.2).
English: The pharmacokinetics of ipilimumab was studied in 785 patients with advanced melanoma who received induction doses ranging from 0.3 to 10 mg/kg administered once every 3 weeks for 4 doses.
Maltese: Il-farmakokinetika ta' ipilimumab ġiet studjata f'785 pazjent b'melanoma avvanzata li rċivew dożi ta' induzzjoni li kienu jvarjaw minn 0.3 sa 10 mg/kg mogħtija darba kull 3 ġimgħat għal 4 dożi.
English: Permanently discontinue YERVOY in patients with the following adverse reactions.
Maltese: Waqqaf YERVOY b'mod permanenti f'pazjenti bir-reazzjonijiet avversi li ġejjin.
English: One female infant had unilateral renal agenesis of the left kidney and ureter, and one male infant had an imperforate urethra with associated urinary obstruction and subcutaneous scrotal edema.
Maltese: Tarbija femminili waħda kellha aġenesi renali unilaterali tal-kilwa tax-xellug u l-ureteru, u tarbija maskili wieħed kellu uretra mhux perforata bis-sadd assoċjat tal-awrina u edema taħt il-ġilda taliskrotu.
English: Evaluation of laboratory results to assess endocrine function may be performed before corticosteroid therapy is initiated.
Maltese: Levalwazzjoni tar-riżultati tal-laboratorju biex tiġi evalwata l-funzjoni endokrinali tista' titwettaq qabel ma tinbeda t-terapija bil-kortikosterojdi.
English: Resolution occurred in 37 patients (77.1%) with a median time to resolution of 13.2 weeks (range: 0.1+-106.0+).
Maltese: Fejqan seħħ f'37 pazjent (77.1 %) bi żmien medjan għallfejqan ta' 13.2 ġimgħat (medda: 0.1+-106.0+).
English: Myasthenia gravis-like symptoms have also been reported in < 1% of patients who received higher doses of ipilimumab in clinical trials.
Maltese: Sintomi bħal ta' myasthenia gravis ġew irrapportati wkoll f'< 1% tal-pazjenti li rċivew dożi ogħla ta' ipilimumab fi provi kliniċi.
English: Median time to onset was 2.0 months (range: 0.4-26.8).
Maltese: Nivolumab - proporzjon ta' periklu: 0.60 (0.43, 0.84)
English: After 28 months of follow-up, median durations of response for patients with tumour PD-L1 expression level ≥5% were not reached (range: 0+-31.6+) in the combination arm, not reached (range: 2.8-30.6+) in the nivolumab monotherapy arm and not reached (range: 1.4-30.6+) in the ipilimumab arm. At tumour PD-L1 expression <5%, median durations of response were not reached (range: 0+-33.3+) in the combination arm, not reached (range: 0+-32.3+) in the nivolumab monotherapy arm and 18.2 months (range: 0.0+-31.5+) in the ipilimumab monotherapy arm.
Maltese: Wara 28 xahar ta' follow up, it-tul medjan ta' rispons għal pazjenti b'livell tal-espressjoni ta' PD-L1 tattumur ta' ≥5% ma ntlaħaqx (medda: 0+-31.6+) fil-fergħa ta' kombinazzjoni, ma ntlaħaqx (medda: 2.830.6+) fil-fergħa ta' monoterapija b'nivolumab u ma ntlaħaqx (medda: 1.4-30.6+) fil-fergħa ta' ipilimumab.