FrancophonIA/ELRC3.0 huggingface dataset:
English: Fatalities due to gastrointestinal perforation have been reported in clinical trials (see section 4.8).
Maltese: Fatalitajiet minħabba perforazzjoni gastrointestinali ġew irrapportati fil-provi kliniċi (ara sezzjoni 4.8).
English: ** ipilimumab in combination with nivolumab for the first 4 doses then followed by nivolumab monotherapy in RCC.
Maltese: ** ipilimumab f'kombinazzjoni ma' nivolumab għall-ewwel 4 dożi mbagħad segwit minn monoterapija b'nivolumab f'RCC.
English: DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
Maltese: DRESS tesebixxi ruħha bħala raxx b'eosinofilja assoċjata ma' wieħed jew aktar tal-karatteristiċi li ġejjin: deni, limfodenopatija, edema tal-wiċċ u involviment tal-organi interni (epatiċi, renali, pulmonari).
English: Rare autoimmune thyroiditisd, thyroiditisd Metabolism and nutrition disorders Very common decreased appetite Common dehydration, hypokalemia
Maltese: Rari tirojdite awtoimmunid, tirojdited Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna nuqqas t'aptit Komuni deidratazzjoni, ipokalemija
English: In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg, the incidence of hypersensitivity/infusion reactions was 3.8% (17/448); all were Grade 1 or 2 in severity.
Maltese: F'pazjenti kkurati b'ipilimumab 3 mg/kg flimkien ma' nivolumab 1 mg/kg, l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva/infużjoni kienet 3.8% (17/448); kollha kienun ta' Grad 1 jew 2 fis-severità.
English: Fatal hepatic failure has been reported in < 1% of patients who received ipilimumab 3 mg/kg monotherapy.
Maltese: Insuffiċjenza epatika fatali ġiet irrapportata f'< 1% tal-pazjenti li rċivew ipilimumab 3 mg/kg waħdu.
English: nivolumab Median OS (95% CI)
Maltese: nivolumab OS medjana (95 % CI)
English: Less than 2% of patients with advanced melanoma who received ipilimumab in Phase 2 and 3 clinical trials developed antibodies against ipilimumab.
Maltese: Fi provi kliniċi tal-Fażi 2 u 3 inqas minn 2% tal-pazjenti b'melanoma avvanzata li ngħataw ipilimumab żviluppaw antikorpi kontra ipilimumab.
English: All patients were HLA-A2*0201 type; this HLA type supports the immune presentation of gp100.
Maltese: Il-pazjenti kollha kienu tat-tip HLA-A2*0201; dan it-tip ta' HLA jappoġġja l-preżentazzjoni immuni ta' gp100.
English: Median time to onset was 1.5 months (range: 0.0-30.1).
Maltese: Iż-żmien medjan għall-bidu kien 1.5 xhur (medda: 0.0-30.1).
English: Patients with ocular melanoma, primary CNS melanoma and active brain metastases were not included in the MDX010-20 trial (see section 5.1).
Maltese: Pazjenti b'melanoma okulari, b'melanoma primarja tas-CNS u b'metastasi attiva tal-moħħ ma ġewx inklużi fil-prova MDX010-20 (ara sezzjoni 5.1).
English: Resolution occurred in 192 patients (72.2%) with a median time to resolution of 11.6 weeks (range: 0.1-126.7+).
Maltese: Il-fejqan seħħ f'192 pazjent (72.2 %) bi żmien medjan għall-fejqan ta' 11.6 ġimgħat (medda: 0.1-126.7+).
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).
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' nefrite jew ta' disfunzjoni tal-kliewi kienet ta' 8.8 % (48/547).
English: 10 months
Maltese: 10 xhur
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).
Maltese: F'pazjenti kkurati b'ipilimumab 3 mg/kg flimkien ma' nivolumab 1 mg/kg fil-melanoma, l-inċidenza ta' nefrite jew disfunzjoni tal-kliewi kienet 5.1% (23/448).
English: YERVOY infusion
Maltese: Infezzjonijiet u infestazzjonijiet
English: Mild to moderate Immune-related adverse reactions
Maltese: Reazzjonijiet avversi tal-ġilda relatati malimmunità
English: NAME OF THE MEDICINAL PRODUCT YERVOY 5 mg/ml sterile concentrate
Maltese: YERVOY 5 mg/ml konċentrazzjoni sterili
English: Patients must be monitored for gastrointestinal signs and symptoms that may be indicative of immune-related colitis or gastrointestinal perforation.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi gastrointestinali li jistgħu jkunu indikattivi ta' kolite jew perforazzjoni gastrointestinali relatati mal-immunità.
English: Ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg
Maltese: Ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg
English: The following side effects have been reported with ipilimumab in combination with nivolumab:
Maltese: Effetti sekondarji oħra li ġew irrapportati (frekwenza mhux magħrufa) b'ipilimumab f'kombinazzjoni ma' nivolumab jinkludu:
English: Minimum follow-up for the analysis of ORR was 28 months.
Maltese: Il-follow-up minimu għall-analiżi ta' ORR kien ta' 28 xahar.
English: Each ml of this medicinal product contains 0.1 mmol (or 2.30 mg) sodium.
Maltese: Kull millilitru ta' dan il-prodott mediċinali fih 0.1 mmol (jew 2.30 mg) ta' sodium.
English: The following side effects have been reported in patients receiving 3 mg/kg ipilimumab alone:
Maltese: Ġew irrappurtati l-effetti sekondarji li ġejjin f'pazjenti li qed jirċievu 3 mg/kg ipilimumab waħdu:
English: Common musculoskeletal paing arthritis, muscle spasms, muscular weakness
Maltese: Komuni uġigħ muskoluskeletrikug artrite, spażmi fil-muskoli, dgħjufija muskolari
English: Common adrenal insufficiency, hypopituitarism, hypophysitis, hyperthyroidism, thyroiditis adrenal insufficiencyc, hypophysitisc,
Maltese: Komuni insuffiċjenza adrenali, ipopitwitariżmu, ipofiżite, ipertirojdiżmu, tirojdite insuffiċjenza adrenalic, ipofiżitec, tirojdite, dijabete mellitusc
English: Hazard ratioa 99.1% CI p-valueb,h Median (95% CI) Confirmed objective response (BICR)
Maltese: Sopravivenza globali Avvenimenti Proporzjon ta' periklua 99.8% CI valur-pb, c Medjan (CI ta' 95%)
English: c p-value is compared to alpha 0.002 in order to achieve statistical significance.
Maltese: c il-valur-p qed jiġi mqabbel ma' alpha 0.002 sabiex tinkiseb sinifikanza statistika.
English: Among the patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in CA209214, 169/547 (31%) had the first onset of Grade 3 or 4 adverse reactions during the initial combination phase.
Maltese: Fost il-pazjenti li ngħataw kura b'ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg f'CA209214, 169/547 (31%) kellhom l-ewwel tfaċċar ta' reazzjonijiet avversi tal-Grad 3 jew 4 waqt il-fażi tal-kombinazzjoni inizjali.
English: Severe symptoms (abdominal pain, severe diarrhoea or significant change in the number of stools, blood in stool, gastrointestinal haemorrhage, gastrointestinal perforation)
Maltese: Sintomi severi (uġigħ addominali, dijarea severa jew tibdil sinifikanti fl-ammont ta' ppurgar, demm fl-ippurgar, emorraġija gastrointestinali, perforazzjoni gastrointestinali)
English: Nivolumab+Ipilimumab (events: 77/155), median and 95% CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (events: 86/171), median and 95% CI: 14.00 (7.03, N.A.) Ipilimumab (events: 129/164), median and 95% CI: 3.91 (2.83, 4.17)
Maltese: Nivolumab+Ipilimumab (avvenimenti: 77/155), medjan u 95 % CI: 12.35 (8.74, N.A.) ──Δ─── Nivolumab (avvenimenti: 86/171), medjan u 95 % CI: 14.
English: Sunitinib (events: 209/422), median and 95.0% CI: 26.97 (22.08, 34.83)
Maltese: Ipilimumab (avvenimenti: 159/202), medjan u 95% CI: 2.83 (2.76, 3.09)
English: Permanently discontinue treatment (see section 4.4)
Maltese: Waqqaf il-kura b'mod permanenti (ara sezzjoni 4.4)
English: At the time of this analysis, the hazard ratio was 0.66; (99.8% CI 0.48-0.91) with 166/425 events in the combination arm and 209/422 events in the sunitinib arm. At 18 months, the OS rate was 74.3 (95% CI 69.8-78.2) for ipilimumab in combination with nivolumab and 59.9 (95% CI 54.9-64.5) for sunitinib.
Maltese: Fiż-żmien ta' din l-analiżi, il-proporzjon ta' periklu kien ta' 0.66; (99.8% CI 0.48-0.91) b'166/425 avveniment fil-fergħa ta' kombinazzjoni u 209/422 avveniment fil-fergħa ta' sunitinib.
English: Figure 1: Overall Survival with ipilimumab 3 mg/kg in pooled analysis
Maltese: Globali b'ipilimumab 3 mg/kg f'analiżi kondiviża
English: Ipilimumab in combination with nivolumab (see section 4.2)
Maltese: Ipilimumab flimkien ma' nivolumab (ara sezzjoni 4.2)
English: In CA184178, deaths were reported at least 90 days of the last dose.
Maltese: F'CA184178, l-imwiet kienu rappurtati talinqas 90 ġurnata wara l-aħħar doża.
English: At 24 months, the OS rate was 66.5 (95% CI 61.8-70.9) for ipilimumab in combination with nivolumab and 52.9 (95% CI 47.9- 57.7) for sunitinib.
Maltese: Wara 24 xahar, ir-rata tal-OS kienet ta' 66.5 (95% CI 61.8-70.9) għal ipilimumab f'kombinazzjoni ma' nivolumab u ta' 52.9 (95% CI 47.
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
Maltese: Rari ħafna reazzjoni anafilattika Disturbi fis-sistema endokrinarja Komuni ipopitwitariżmu (inkluż ipofiżite)ċ, ipotirojdiżmuċ
English: Number of Subjects at Risk Nivolumab + Ipilimumab
Maltese: Numru ta' Individwi f'Riskju Nivolumab + Ipilimumab Nivolumab
English: (95% CI) Difference in ORR (95% CI)d p-valuee,f
Maltese: (95 % CI) Differenza fl-ORR (CI ta' 95%)d valur-pe,f Rispons komplet (CR) Rispons parzjali (PR) Marda stabbli (SD) Tul medjan tar-risponsg Xhur (medda)
English: Randomisation was stratified by PD-L1 expression (≥ 5% vs. < 5% tumour cell membrane expression), BRAF status, and M stage per the American Joint Committee on Cancer (AJCC) staging system.
Maltese: Irrandomizzazzjoni ġiet stratifikata permezz tal-espressjoni PD-L1 tal-membrana taċ-ċellula tat-tumur), status BRAF, u stadju M skont is-sistema ta' stadji tal-Kumitat Konġunt Amerikan dwar il-Kanċer (AJCC).
English: In the ipilimumab 3 mg/kg monotherapy group, hypopituitarism of any severity was reported in 4% of patients.
Maltese: Fil-grupp li ngħata ipilimumab 3 mg/kg waħdu, ipopitwitariżmu ta' kwalunkwe severità ġie rrapportat f'4% tal-pazjenti.
English: Ipilimumab 3 mg/kg was administered to four patients and ipilimumab 10 mg/kg was administered to eight patients.
Maltese: Ipilimumab 3 mg/kg ingħata lil erba' pazjenti u ipilimumab 10 mg/kg ingħata lil tmien pazjenti.
English: When administered in combination with nivolumab, the CL of ipilimumab increased by 5.7% in the presence of anti-ipilimumab antibodies and the CL of nivolumab increased by 20% in the presence of presence of anti-nivolumab antibodies.
Maltese: Meta ngħata f'kombinazzjoni ma' nivolumab, is-CL ta' ipilimumab żdiedet b'5.7% fil-preżenza ta' antikorpi kontra ipilimumab u s-CL ta' nivolumab żdiedet b'20% fil-preżenza ta' antikorpi kontra nivolumab.
English: PHARMACEUTICAL FORM AND CONTENTS Sterile concentrate
Maltese: U KONTENUT Konċentrazzjoni sterili
English: Ipilimumab has been administered to approximately 10,000 patients in a clinical program evaluating its use with various doses and tumour types.
Maltese: Ipilimumab ingħata lil madwar 10,000 pazjent fi programm kliniku li evalwa l-użu tiegħu ma' dożi differenti u tipi varji ta' tumuri.
English: Clinical experience with ipilimumab-associated endocrinopathy is limited.
Maltese: L-esperjenza klinika b'endokrinopatija assoċjata ma' ipilimumab hi limitata.
English: Common dermatitis, erythema, vitiligo, urticaria, eczemad, alopecia, night sweats, dry skin Uncommon toxic epidermal necrolysisb,c, leukocytoclastic vasculitis, skin exfoliation, hair colour changesd
Maltese: Komuni dermatite, eritema, vitiligo, urtikarja, ekżemad, alopeċja, għaraq matul il-lejl, ġilda xotta
English: Sequential administration with vemurafenib
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: The median duration of time from initial diagnosis to randomisation was 0.4 years in both the ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg and sunitinib groups.
Maltese: It-tul ta' żmien medjan mid-dijanjożi inizjali sar-randomizzazzjoni kien ta' 0.4 snin f'kemm il-grupp ta' ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg u ta' sunitinib.
English: No differences in the spectrum of irARs reported in adults and the paediatric population were evident.
Maltese: Ma dehret l-ebda differenza fl-ispettru ta' irARs irrappurtati fl-adulti u filpopolazzjoni pedjatrika.
English: Severe pneumonitis or interstitial lung disease, including fatal cases, has been observed with ipilimumab in combination with nivolumab (see section 4.8).
Maltese: Ġiet osservata pulmonite jew marda interstizjali tal-pulmun severa, inkluż każijiet fatali, b'ipilimumab flimkien ma' nivolumab (ara sezzjoni 4.8).
English: Immune-related gastrointestinal reactions
Maltese: Reazzjonijiet gastrointestinali relatati mal-immunità
English: Fatal Guillain-Barré syndrome has been reported in < 1% of patients who received ipilimumab 3 mg/kg in combination with gp100.
Maltese: Is-sindromu fatali ta' Guillain-Barré ġie rrapportat f'< 1% tal-pazjenti li rċivew ipilimumab 3 mg/kg flimkien ma' gp100.
English: Of the patients who were treated with ipilimumab in combination with nivolumab and evaluable for the presence of anti-ipilimumab antibodies, the incidence of anti-ipilimumab antibodies ranged from 6.3 to 8.4%%.
Maltese: Mill-pazjenti li ngħataw kura b'ipilimumab f'kombinazzjoni ma' nivolumab u li setgħu jiġu vvalutati għall-preżenza ta' antikorpi kontra ipilimumab, l-inċidenza ta' antikorpi kontra ipilimumab varjat minn 6.3% sa 8.4%.
English: f p-value is compared to alpha 0.001 in order to achieve statistical significance.
Maltese: f il-valur-p qed jiġi mqabbel ma' alpha 0.001 sabiex tinkiseb sinifikanza statistika.
English: Median time to onset of these endocrinopathies was 1.9 months (range: 0.0-28.1).
Maltese: Iż-żmien medjan għall-bidu ta' dawn l-endokrinopatiji kien 1.9 xhur (medda: 0.0-28.1).
English: Median time to onset was 1.2 months (range: 0.0-22.6).
Maltese: Iż-żmien medjan għall-bidu kien 1.2 xhur (medda: 0.0-22.6).
English: Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes.
Maltese: Ħalli l-ammont xieraq ta' kunjetti ta' YERVOY joqogħdu fit-temperatura tal-kamra għal madwar 5 minuti.
English: The frequency of severe (Grade 3 or 4) diarrhoea and severe (Grade 3 or 4) colitis was 5% each.
Maltese: Il-frekwenza ta' dijarea severa (Grad 3 jew 4) u kolite severa (Grad 3 jew 4) kienet ta' 5% kull waħda.
English: Patients with severe (Grade 3 or 4) endocrinopathy controlled with hormone replacement therapy may remain on therapy.
Maltese: Pazjenti b'endokrinopatija severa (Grad 3 jew 4) ikkontrollata b'terapija ta' sostituzzjoni tal-ormoni jistgħu jibqgħu fuq it-terapija.
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
Maltese: Biex tiddilwi l-konċentrat ta' YERVOY, tista' tuża jew: sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni; jew 50 mg/ml (5%) glucose soluzzjoni għall-injezzjoni
English: Rare decreased blood thyroid stimulating hormoned, decreased thyroxined, abnormal blood prolactind a
Maltese: Rari ormon li jistimula t-tirojde mnaqqasd, thyroxine imnaqqasd, prolaktin anormali fiddemmd a
English: h p-value is compared to alpha 0.009 in order to achieve statistical significance.
Maltese: h il-valur-p qed jiġi mqabbel ma' alpha 0.009 sabiex tinkiseb sinifikanza statistika. “+” tindika osservazzjoni ċensurata.
English: Rare serous retinal detachment serous retinal detachment
Maltese: Mhux magħruf Sindrome ta' Vogt-Koyanagi-Haradah Rari stakkament retinali serju stakkament retinali serju
English: In patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, time to onset of moderate to severe or fatal (Grade 2-5) immune-related hepatotoxicity ranged from 3 to 9 weeks from the start of treatment.
Maltese: F'pazjenti li rċivew ipilimumab 3 mg/kg waħdu fi studju MDX010-20, iż-żmien għall-bidu ta' epatotossiċità severa jew fatali relatata mal-immunità (Grad 2-5) varja minn 3 sa 9 ġimgħat mill-bidu tal-kura.
English: One 40 ml vial contains 200 mg of ipilimumab.
Maltese: Kunjett wieħed ta' 40 ml fih 200 mg ta' ipilimumab.
English: Ipilimumab is associated with serious immune-related gastrointestinal reactions.
Maltese: Ipilimumab hu assoċjat ma' reazzjonijiet gastrointestinali serji relatati mal-immunità.
English: Nivolumab+Ipilimumab (events: 29/68), median and 95% CI: N.A. (9.72, N.A.) ──Δ─── Nivolumab (events: 38/80), median and 95% CI: 21.95 (8.90, N.A.) Ipilimumab (events: 57/75), median and 95% CI: 3.94 (2.79, 4.21)
Maltese: 38/80), medjan u 95 % CI: 21.95 (8.90, N.A.) Ipilimumab (avvenimenti: 57/75), medjan u 95% CI: 3.94 (2.79, 4.21)
English: ORR (95% CI) by tumour PD-L1 expression n=210
Maltese: Propozjon ta' ≥12-il xahar fit-tul Propozjon ta' ≥24 xahar fit-tul ORR (95% CI) skont l-espressjoni PD-L1 tat-tumur n=210
English: Unless otherwise specified, the data below reflect exposure to ipilimumab at 3 mg/kg in clinical trials of melanoma.
Maltese: Sakemm ma jkunx speċifikat mod ieħor, id-dejta ta' hawn taħt tirrifletti l-espożizzjoni għal ipilimumab f'doża ta' 3 mg/kg fi provi kliniċi dwar melanoma.
English: Additionally, developmental external or visceral abnormalities were identified in the urogenital system of 2 infants exposed in utero to ipilimumab.
Maltese: Barra minn hekk, kienu identifikati abnormalitajiet esterni jew vixxerali tal-iżvilupp fis-sistema uroġenitali ta' 2 trabi esposti in utero għal ipilimumab.
English: Each vial contains 50 mg ipilimumab.
Maltese: Kull kunjett fih 50 mg ta' ipilimumab.
English: NAME OF THE MEDICINAL PRODUCT YERVOY 5 mg/ml concentrate for solution for infusion Ipilimumab
Maltese: YERVOY 5 mg/ml konċentrat għal soluzzjoni għall-infużjoni ipilimumab
English: Stable disease was achieved in two patients at the ipilimumab 5mg/kg dose, one with a duration of > 22 months.
Maltese: Marda stabbli inkisbet f'żewġ pazjenti bid-doża ta' ipilimumab 5mg/kg, wieħed b'tul ta' żmien ta' > 22 xahar.
English: Common gastrointestinal haemorrhage, colitisb,c, constipation, gastroesophageal reflux disease, abdominal pain, mucosal inflammationd
Maltese: Komuni emorraġija gastrointestinali, koliteb,ċ, stitikezza, mard tar-rifluss gastroesofagali, uġigħ adominali, infjammazzjoni mukosalid
English: Upon repeated dosing of ipilimumab administered every 3 weeks, CL was found to be time-invariant, and minimal systemic accumulation was observed as evident by an accumulation index 1.5 fold or less.
Maltese: Wara l-għoti ta' dożi ripetuti ta' ipilimumab kull 3 ġimgħat, is-CL instabet li ma kintix tiddependi fuq il-ħin, u kienet osservata akkumulazzjoni sistemika minima kif evidenti minn indiċi ta' akkumulazzjoni ta' 1.5 darbiet jew inqas.
English: Neurological: Moderate (Grade 2)b unexplained motor neuropathy, muscle weakness, or sensory neuropathy (lasting more than 4 days)
Maltese: Newroloġiċi: Newropatija moderata mhux spjegabbli tal-moviment (Grad 2)b dgħufija fil-muskoli, jew newropatija sensorjali (li ddum aktar minn 4 ijiem)
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.
Maltese: Fi studju MDX010-20 (ara sezzjoni 5.1), ipilimumab f'doża ta' 3 mg/kg bi jew mingħajr gp100, żied l-ALC matul il-perjodu tad-dożaġġ ta' induzzjoni, iżda ma ġiet osservata l-ebda bidla sinifikanti fl-ALC fil-grupp tal-kontroll ta' pazjenti li rċivew tilqima investigattiva b'gp100 peptide waħdu.
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.
Maltese: F'pazjenti li ngħataw kura b'ipilimumab 1 mg/kg f'kombinazzjoni ma' nivolumab 3 mg/kg, linċidenza ta' reazzjonijiet ta' sensittività eċċessiva/relatati mal-infużjoni kienet ta' 4.0% (22/547); kollha kienu ta' severità tal-Grad 1 jew 2.
English: Guidelines for permanent discontinuation or withholding of doses are described in Tables 3A and 3B for YERVOY as monotherapy, and in Table 3C for YERVOY in combination with nivolumab or administration of the second phase of treatment (nivolumab monotherapy) following combination treatment.
Maltese: Il-linji gwida għat-twaqqif permanenti jew għat-twaqqif temporanju tad-dożi huma deskritti fit-Tabella 3A u 3B għal YERVOY bħala monoterapija, u fit-Tabella 3C għal YERVOY f'kombinazzjoni ma' nivolumab jew għall-għoti tat-tieni fażi tal-kura (monoterapija b'nivolumab) wara kura kombinata.
English: Respiratory, thoracic and mediastinal disorders Very common dyspnoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna dispnea
English: In patients who received ipilimumab 3 mg/kg monotherapy in a Phase 3 study of advanced (unresectable or metastatic) melanoma (MDX010-20, see section 5.1), the median time to onset of severe or fatal (Grade 3-5) immune-related gastrointestinal reactions was 8 weeks (range 5 to 13 weeks) from the start of treatment.
Maltese: F'pazjenti li rċivew ipilimumab 3 mg/kg waħdu fi studju ta' Fażi 3 dwar melanoma (li ma tistax tinqata' jew metastatika) avvanzata (MDX010-20, ara sezzjoni 5.1), iż-żmien medjan għall-bidu ta' reazzjonijiet gastrointestinali severi jew fatali relatati mal-immunità (Grad 3-5) kien ta' 8 ġimgħat (medda ta' 5 sa 13-il ġimgħa) mill-bidu tal-kura.
English: Frequencies are based on pooled data from 9 clinical trials investigating the ipilimumab 3 mg/kg dose in melanoma.
Maltese: Il-frekwenzi huma bbażati fuq dejta miġbura minn 9 provi kliniċi li jinvestigaw doża ta' ipilimumab 3 mg/kg f'melanoma.
English: PD-L1 expression ≥ 1%
Maltese: Espressjoni ta' PD-L1 ≥ 1 %
English: Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
Maltese: Infliximab ma għandux jintuża jekk ikun hemm suspett ta' perforazzjoni gastrointestinali jew sepsis (ara s-Sommarju talKaratteristiċi tal-Prodott għal infliximab).
English: Common vitiligo, dry skin, erythema, alopecia, urticaria dry skin, erythema, urticaria
Maltese: Komuni vitiligo, ġilda xotta, eritema, alopeċja, urtikarja ġilda xotta, eritema, urtikarja
English: Randomised phase 2 study of ipilimumab in combination with nivolumab and ipilimumab (CA209069)
Maltese: Studju ta' fażi 2 randomizzat ta' ipilimumab flimkien ma' nivolumab u ipilimumab (CA209069)
English: Uncommon uveitis
Maltese: Mhux komuni uveite
English: No other endocrine abnormalities were reported.
Maltese: Ma ġiet rappurtata l-ebda anormalità endokrinali oħra.
English: In clinical trials, a single dose of infliximab 5 mg/kg was added unless contraindicated.
Maltese: Fil-provi kliniċi, doża waħda ta' infliximab 5 mg/kg ġiet miżjuda, ħlief jekk kontraindikat.
English: Table 5: Adverse reactions with ipilimumab in combination with nivolumab Ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg*
Maltese: Reazzjonijiet avversi b'ipilimumab f'kombinazzjoni ma' nivolumab Ipilimumab 3 mg/kg f'kombinazzjoni ma' nivolumab 1 mg/kg*
English: Table 12: Efficacy results in intermediate/poor risk patients (CA209214)
Maltese: Tabella 12: Riżultati tal-effikaċja f'pazjenti b'riskju intermedju/fqir (CA209214)
English: Patients with a mild to moderate (Grade 1 or 2) rash may remain on ipilimumab therapy with symptomatic treatment (e.g. antihistamines).
Maltese: Pazjenti b'raxx minn ħafif sa moderat (Grad 1 jew 2), jistgħu jibqgħu fuq it-terapija b'ipilimumab b'kura sintomatika (eż. antistamini).
English: 3 mg/kg n = 111 10 mg/kg n = 325
Maltese: 10 mg/kg n = 325
English: Post-marketing event (also see section 4.4).
Maltese: Avveniment ta' wara t-tqegħid fuq is-suq (ara wkoll sezzjoni 4.4).