FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who did not achieve ≥ 85% maximum predicted heart rate (MPHR) and/or ≥ 5 METS (metabolic equivalents), transitioned into a 3-5 minutes walking recovery where during the first 3 minutes of recovery, patients were randomized 1:1.
Maltese: METS (ekwivalenti metaboliċi), għamlu tranżizzjoni ta' mixi b' rkupru għal 3-5 minuti fejn matul l-ewwel 3 minuti ta' rkupru, pazjenti ġew randomised 1:1.
English: The metabolism of regadenoson is unknown in humans.
Maltese: Il-metaboliżmu ta' regadenoson mhuwiex magħruf fil-bnedmin.
English: The incidence of a FEV1 reduction > 15% from baseline after regadenoson administration was assessed in three randomised, controlled clinical studies.
Maltese: L-inċidenza ta' FEV1 tnaqqis ta' > 15% mil-linja bażi wara l-għoti ta' regadenoson kienet evalwata fi tliet studji kliniċi kkontrollati, li fihom ilparteċipanti ntgħażlu b'mod każwali.
English: The images from MPI 1 and MPI 2 were compared for presence or absence of perfusion defects.
Maltese: L-immaġini minn MPI 1 u MPI 2 tqabblu għal preżenza jew assenza ta' difetti ta' perfużjoni.
English: Musculoskeletal and connective tissue disorders: Common
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi:
English: Excipients: Disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, propylene glycol, disodium edetate, water for injections
Maltese: Disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, propylene glycol, disodium edetate, ilma għall-injezzjonijiet Ara l-fuljett ta' tagħrif għal iktar informazzjoni.
English: Measurement of FFR
Maltese: Kejl tal-FFR
English: • being sick (vomiting), feeling sick (nausea)
Maltese: • tkun imdardar (rimettar), tħossok imdardar (nawseja)
English: • headache, dizziness
Maltese: • uġigħ fil-ġogi
English: C-radiolabeled regadenoson to rats and dogs, most radioactivity (85-96%) was excreted in the form of unchanged regadenoson.
Maltese: Wara l-għoti ġħo-vini ta' 14C regadenoson radjutikkettat lil firien u klieb, il-biċċa l-kbira tar-radjuattività (85-96%) tneħħiet fis-sura ta' regadenoson mhux mibdul.
English: Aminophylline may be used to attenuate severe or persistent adverse reactions to regadenoson.
Maltese: Aminophylline jista' jintuża biex inaqqas reazzjonijiet avversi severi jew persistenti għal regadenoson.
English: Vision blurred, eye pain Ear and labyrinth disorders: Uncommon
Maltese: Vista mċajpra, uġigħ fl-għajnejn Disturbi fil-widnejn u fis-sistema labirintika:
English: 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.
Maltese: 5 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni għandha tingħata immedjatament wara l-injezzjoni ta' Rapiscan.
English: It is injected directly into a vein, as a single dose of 400 micrograms in a 5 ml solution - the injection will take about 10 seconds to complete.
Maltese: Jiġi injettat direttament ġo vina, bħala doża waħda ta' 400 mikrogramma f'soluzzjoni ta' 5 ml - l-injezzjoni ser tieħu madwar 10 sekondi biex titlesta.
English: • fits, fainting, mini strokes (including weakness of the face or an inability to speak), reduced responsiveness (which may include a comatose state), trembling, sleepiness
Maltese: • konvulżjonijiet, ħass ħażin, mini-puplesiji (li jinkludu dgħufija tal-wiċċ jew ma tkunx kapaċi titkellem), rispons imnaqqas (li jista' jinkludi stat komatuż), rogħda, irqad
English: The disposition of regadenoson was studied in 18 subjects with various degrees of renal function and in 6 healthy subjects.
Maltese: Id-dispożizzjoni ta' regadenoson kienet studjata fi 18-il persuna b'diversi gradi ta' indeboliment talkliewi u f'6 persuni b'saħħithom.
English: Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents like regadenoson.
Maltese: Waqfien kardijaku fatali, arritmiji ventrikulari ta' periklu għall-ħajja u infart mijokardijaku jistgħu jirriżultaw mill-iskemija kkaġunata minn mediċini farmakoloġiċi li jikkawżaw stress bħal regadenoson.
English: Convulsions, syncope, transient ischaemic attack, unresponsiveness to stimuli, depressed level of consciousness, tremor, somnolence
Maltese: Konvulżjonijiet, sinkope, attakk iskemiku transitorju, l-ebda rispons għal stimuli, livell baxx ta' koxjenza, rogħda, ngħas
English: In the second study in 48 patients with mild to moderate asthma who had previously been shown to have bronchoconstrictive reactions to adenosine monophosphate, the rate of FEV1 reduction > 15% from baseline was the same (4%) following both regadenoson and placebo dosing.
Maltese: Fit-tieni studju li sar fuq 48 pazjent li kellhom ażżma minn ħafifa sa moderata, li fil-passat intwera li kellhom reazzjonijiet ta' restrizzjoni talbronki għal adenosine monophosphate, ir-rata ta' FEV1 tnaqqis ta' > 15% mil-linja bażi kienet l-istess (4%) wara d-dożaġġ kemm b'regadenoson kif ukoll bi plaċebo.
English: Regadenoson preferentially increases blood flow in coronary relative to peripheral (forelimb, brain, pulmonary) arterial vascular beds in the anaesthetised dog.
Maltese: Regadenoson iżid b'mod preferenzjali l-fluss tad- demm filkoronarja fir-rigward ta' beds vaskulari arterjali periferali (tar-riġlejn ta' quddiem, tal-moħħ, talpulmun) fi klieb anestetizzati.
English: Long QT syndrome
Maltese: Sindrome ta' QT twil
English: Patients with a recent history of serious uncontrolled ventricular arrhythmia, myocardial infarction, or unstable angina, a history of greater than first degree AV block, or with symptomatic bradycardia, sick sinus syndrome, or a heart transplant were excluded.
Maltese: Pazjenti bi storja medika riċenti ta' arritmija ventrikulari serja mhux ikkontrollata, infart mijokardijaku, jew anġina instabbli, storja medika ta' imblokk AV ta' iktar mill-ewwel grad, jew bi bradikardija sintomatika, is-sindrome ta' sinus marid, jew trapjant talqalb, kienu esklużi.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi talProdott, sezzjoni 4.2).
English: Regadenoson stimulates sympathetic output and may increase the risk of ventricular tachyarrhythmias in patients with a long QT syndrome.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott mediċinali.
English: Aminophylline may be used to attenuate severe or persistent adverse reactions to regadenoson but should not be used solely for the purpose of terminating a seizure induced by regadenoson (see section 4.4).
Maltese: Aminophylline jista' jintuża biex inaqqas reazzjonijiet avversi severi jew persistenti għal regadenoson iżda ma għandux jintuża biss għallgħanijiet ta' terminazzjoni ta' aċċessjoni kkaġunata minn regadenoson (ara sezzjoni 4.4).
English: Children and adolescents Rapiscan should not be used in children and adolescents below the age of 18 years.
Maltese: Tfal u adolexxenti Rapiscan m'għandux jintuża fi tfal u adolexxenti li għandhom inqas minn 18-il sena.
English: Regadenoson may cause myocardial ischaemia (potentially associated with fatal cardiac arrest, lifethreatening ventricular arrhythmias, and myocardial infarction), hypotension leading to syncope and transient ischaemic attacks, elevated blood pressure leading to hypertension and hypertensive crises, and SA/AV node block leading to first, second or third degree AV block, or sinus bradycardia requiring intervention (see section 4.4).
Maltese: Regadenoson jista' jikkawża iskemija mijokardijaka (potenzjalment assoċjata ma' waqfien kardijaku fatali, arritmiji ventrikulari ta' periklu għall-ħajja, u infart mijokardijaku), pressjoni baxxa li twassal għal sinkope u attakki iskemiċi transitorji, pressjoni tad-demm għolja li twassal għal pressjoni għolja u kriżi maħluqa minn pressjoni għolja, u imblokk SA/AV tan-nodes li jwassal għal imblokk AV talewwel, tat-tieni jew tat-tielet grad, jew bradikardija tas-sinus li tkun teħtieġ intervent (ara sezzjoni 4.4).
English: • Unstable angina that has not been stabilised with medical therapy.
Maltese: • jekk għandek insuffiċjenza tal-qalb.
English: • chest pain
Maltese: • pressjoni tad-demm baxxa
English: In a study of healthy volunteers, symptoms of flushing, dizziness and increased heart rate were assessed as intolerable at regadenoson doses greater than 0.02 mg/kg.
Maltese: Fi studju li sar fuq voluntiera b'saħħithom, sintomi ta' fwawar, sturdament u żieda fir-rata ta' taħbit tal-qalb kienu evalwati bħala li kienu intollerabbli b'dożi ta' regadenoson ta' iżjed minn 0.02 mg/kg.
English: Myocardial uptake of the radiopharmaceutical is proportional to CBF.
Maltese: L-assorbiment tal-prodott radjofarmaċewtiku mill-mijokardju hu proporzjonali għas-CBF.
English: Regadenoson causes a rapid increase in heart rate (see sections 4.4 and 5.1).
Maltese: Regadenoson jikkawża żieda mgħaġla fir-rata ta' taħbit tal-qalb (ara sezzjonijiet 4.4 u 5.1).
English: Repeat dosing within 10 minutes - except in patients where the duration of hyperaemia lasted for more than 10 minutes - caused a similar effect on peak and duration of maximum hyperaemia.
Maltese: Irrepeti ddożaġġ fi żmien 10 minuti - ħlief f'pazjenti fejn id-durata tal-iperimja damet għal aktar minn 10 minuti -ikkawżat effett simili fuq il-milja u d-durata tal-iperimja massima.
English: In these patients, the phenomenon of R-on-T syndrome can occur, wherein an extra beat interrupts the T wave of the previous beat, and this increases the risk of a ventricular tachyarrhythmia.
Maltese: F'dawn il-pazjenti, il-fenomenu tas-sindrome R-on-T jista' jseħħ, fejn taħbita addizzjonali tinterrompi t- T wave tat-taħbita ta' qabel, u dan iżid ir-riskju ta' takiarritmija ventrikulari.
English: For two patients from the exercise with regadenoson group, a serious cardiac adverse reaction was reported.
Maltese: Għal żewġ pazjenti mill-grupp b'eżerċizzju b'regadenoson, ġiet irrappurtata reazzjoni avversa kardijaka serja.
English: In the first and second studies, dyspnoea was reported as an adverse reaction following regadenoson dosing (61% for patients with COPD; 34% for patients with asthma) while no subjects experienced dyspnoea following placebo dosing.
Maltese: Fl-ewwel u fit-tieni studju, qtugħ ta' nifs kien irrappurtat bħala reazzjoni avversa wara d-dożaġġ b'regadenoson (61% għal pazjenti b'COPD; 34% għal pazjenti b'ażżma), filwaqt li ħadd mill-individwi ma kellu qtugħ ta' nifs wara dożaġġ bi plaċebo.
English: Adenosine receptor agonists, including regadenoson induce arterial vasodilation and hypotension.
Maltese: Agonisti tar-riċettur ta' adenosine, li jinkludu regadenoson, jikkaġunaw vasodilatazzjoni arterjali u pressjoni baxxa.
English: Mean APV increased to greater than twice baseline by 30 seconds and decreased to less than half of the maximal effect within 10 minutes (see section 5.2).
Maltese: Il-medja ta' APV żdiedet b'iktar mid-doppju tallinja bażi bi 30 sekonda u naqset għal inqas min-nofs tal-effett massimu fi żmien 10 minuti (ara sezzjoni 5.2).
English: • Rapiscan should be administered as a rapid, 10-second injection into a peripheral vein using a 22-gauge or larger catheter or needle.
Maltese: • Rapiscan għandu jingħata bħala injezzjoni mgħaġla ta' 10 sekondi ġo vina periferali bl-użu ta' kateter jew labra ta' 22-gauge jew akbar.
English: Suboptimal Exercise Stress Test
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: • if you are breast-feeding.
Maltese: • Stati dikumpensati ta' insuffiċjenza tal-qalb.
English: How to store Rapiscan
Maltese: Kif taħżen Rapiscan
English: Use of regadenoson involving exercise has been associated with serious adverse reactions including hypotension, hypertension, syncope and cardiac arrest.
Maltese: L-użu ta' regadenoson bl-involviment tal-eżerċizzju kien assoċjat ma' reazzjonijiet avversi serji li jinkludu pressjoni baxxa, pressjoni għolja, sinkope u arrest kardijaku.
English: Standard catheterisation and FFR measurement techniques are to be followed, and FFR should be measured as the lowest value of Pd/Pa achieved during steady state maximum hyperemia.
Maltese: Għandhom jiġu segwiti tekniki tal-kejl tal-kateterizzazzjoni u tal-FFR standard, u l-FFR għandu jitkejjel bħala l-aktar valur baxx ta' Pd/Pa li jinkiseb waqt iperimja massima fi stat fiss.
English: Throat tightness, throat irritation, cough
Maltese: Dwejjaq fil-gerżuma, irritazzjoni fil-gerżuma, sogħla
English: Paraesthesia, hypoaesthesia, dysgeusia
Maltese: Parestesija, ipoestesija, indeboliment fis-sens tat-togħma
English: Coronary blood flow
Maltese: Fluss tad-demm koronarju
English: Hypersensitivity reactions including: Rash, urticaria, angioedema, anaphylaxis Psychiatric disorders:
Maltese: Raxx, urtikarja, anġjoedema, anafilassi u/jew għafis fil-gerżuma
English: Because regadenoson increases blood flow in normal coronary arteries with little or no increase in stenotic arteries, regadenoson causes relatively less uptake of the radiopharmaceutical in vascular territories supplied by stenotic arteries.
Maltese: Billi regadenoson iżid il-fluss tad-demm f'arterji koronarji normali bi ftit jew l-ebda żieda f'arterji stenotiċi, regadenoson jikkawża relattivament inqas assorbiment tal-prodott radjofarmaċewtiku f'żoni vaskulari fejn id-demm jiġi fornut minn arterji stenotiċi.
English: When administered twice 10 minutes apart in a 24-hour period, full safety data for the second injection of Rapiscan are not available.
Maltese: Meta jingħata 10 minuti bogħod f'perjodu ta' 24 siegħa, m'hemmx disponibbli dejta sħiħa dwar is-sigurtà għat-tieni injezzjoni ta' Rapiscan.
English: The use of bronchodilator therapy for symptoms was not different between regadenoson and placebo.
Maltese: L-użu ta' terapija ta' twessigħ tal-bronki għas-sintomi ma kienx differenti bejn regadenoson u plaċebo.
English: Abdominal distension, diarrhoea, faecal incontinence Skin and subcutaneous tissue disorders: Common
Maltese: Nefħa taż-żaqq, dijarea, inkontinenza tal-ippurgar Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda:
English: These effects usually do not last longer than 30 minutes.
Maltese: Dawn l-effetti normalment ma jdumux iktar minn 30 minuta.
English: More serious side effects include:
Maltese: Reazzjonijiet ta' sensittività eċċessiva inkluż:
English: Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson but should not be used solely for the purpose of terminating a seizure induced by Rapiscan (see section
Maltese: Aminophylline jista' jintuża biex inaqqas reazzjonijiet avversi severi u/jew persistenti għal regadenoson iżda ma għandux jintuża biss għall-għanijiet ta' terminazzjoni ta' aċċessjoni kkaġunata minn Rapiscan (ara sezzjoni 4.4).
English: Renal impairment No dose adjustment is necessary (see section 5.2).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ (ara sezzjoni 5.2).
English: Regadenoson administration may result in adverse reactions such as dizziness, headache, and dyspnoea (see section 4.8) soon after administration.
Maltese: Regadenoson għandu l-potenzjal li jikkawża reazzjonijiet serji u ta' periklu għall-ħajja, li jinkludu dawk elenkati hawn taħt (ara wkoll sezzjoni 4.8).
English: Also, there was no apparent effect of 200 mg or 400 mg of caffeine on regadenoson plasma concentrations.
Maltese: Barra minn hekk, ma kien hemm l-ebda effett apparenti ta' 200 mg jew 400 mg ta' kaffeina fuq konċentrazzjonijiet tal-plasma ta' regadenoson.
English: • rapid breathing
Maltese: • għaraq eċċessiv
English: Patients should avoid consumption of any products containing methylxanthines (e.g. caffeine) as well as any medicinal products containing theophylline for at least 12 hours before Rapiscan administration (see section 4.5).
Maltese: Il-pazjenti għandhom jevitaw il-konsum ta' kwalunkwe prodotti li fihom methylxanthines (eż. kaffeina) kif ukoll kwalunkwe prodotti mediċinali li fihom theophylline għal mill-inqas 12-il siegħa qabel l-għoti ta' Rapiscan (ara sezzjoni 4.5).
English: MA (EU) number
Maltese: Numru tal-MA Isem
English: Immediate Packaging
Maltese: 7 kapsuli
English: (see section 4.2).
Maltese: (ara sezzjoni 4.2).
English: Overall survival a, c, d
Maltese: Sopravivenza totali a, c, d.
English: Grades 1-5 (Frequency category)
Maltese: Gradi 1-5 (Kategorija ta' frekwenza)
English: Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, Ireland
Maltese: Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, L-Irlanda
English: 31st March
Maltese: 31 ta' Marzu
English: Arthritis j
Maltese: Artrite j
English: Tel. aus dem Ausland: +49 69 305 70 13
Maltese: aus dem Ausland: +49 69 305 70 13
English: Guillain-Barre syndrome
Maltese: Sindrome ta' Guillain-Barre
English: Sjogren's syndrome
Maltese: Sindrome ta' Sjogren
English: If any of the above apply to you, or you are not sure, talk to your doctor or nurse before you are given LIBTAYO.
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar dan il-prodott mediċinali.
English: Recommended treatment modifications
Maltese: Modifikazzjonijiet rakkomandati fit-trattament
English: Danmark Sanofi A/S Tlf: +45 45 16 70 00
Maltese: Sanofi A/S Tlf: +45 45 16 70 00
English: a Toxicity should be graded with the current version of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Maltese: (NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events ).
English: Musculoskeletal pain i
Maltese: Uġigħ muskoluskeletriku i
English: laCSCC cemiplimab: 3 mg/kg Q2W (Group 2) (N = 78)
Maltese: laCSCC cemiplimab: 3 mg/kg Q2W (Grupp 2) (N = 78)
English: mCSCC cemiplimab: 350 mg Q3W (Group 3) (N = 56)
Maltese: mCSCC cemiplimab: 350 mg Q3W (Grupp 3) (N = 56)
English: Partial response (PR) Stable disease (SD) Progressive disease (PD)
Maltese: Mard progressiv (PD, Progressive Disease)
English: Progression free survival (PFS)
Maltese: Sopravivenza mingħajr progressjoni (PFS, Progression Free Survival)
English: LIBTAYO 350 mg sterile concentrate cemiplimab
Maltese: LIBTAYO 350 mg konċentrat sterili cemiplimab
English: Table 2:
Maltese: Tabella 2:
English: Gastrointestinal disorders Diarrhoea e
Maltese: Disturbi gastrointestinali Dijarea e
English: Immune system disorders: Immune thrombocytopenic purpura Vascular disorders: Vasculitis
Maltese: Disturbi fis-sistema immuni: Purpura tromboċitopenika immuni Disturbi vaskulari: Vaskulite
English: See ‘Possible side effects' section in section 4.
Maltese: Ara s-sezzjoni ‘Effetti sekondarji possibbli' fis-sezzjoni 4.
English: • Central nervous system problems (such as meningitis)
Maltese: • Problemi fis-sistema nervuża ċentrali (bħal meninġite)
English: Confirmed objective response rate (ORR)
Maltese: Konferma ta' rata oġġettiva ta' rispons (ORR, Objective Response Rate)
English: 22 advanced CSCC patients with PD-L1 < 1%, ORR per independent central review was 40.9% (9/22).
Maltese: Fost 22 pazjent b'CSCC avvanzata b'PD-L1 < 1%, ORR għal kull reviżjoni ċentrali indipendenti kienet 40.9% (9/22).
English: Meningitis b
Maltese: Meninġite b
English: Grade ≥3 with AST or ALT >5×ULN or total bilirubin >3×ULN
Maltese: Grad ≥3 b'AST jew ALT >5×ULN jew bilirubin totali >3×ULN
English: Grade 2 with AST or ALT >3 and ≤5×ULN or total bilirubin >1.5 and ≤3×ULN
Maltese: Grad 2 b'AST jew ALT >3 u ≤5×ULN jew bilirubin totali >1.5 u ≤3×ULN
English: Malta Sanofi S.p.A
Maltese: Sanofi S.p.A.
English: In Groups 1, 2, and 3, median durations of follow-up were 16.5, 9.3, and 8.1 months, respectively.
Maltese: Fi Gruppi 1, 2, u 3, medjan ta' segwitu kien 16.5, 9.3, u 8.1 xhur, rispettivament.
English: 95% CI for ORR Complete response (CR)
Maltese: 95% CI għal ORR
English: (Grade 4), Paraneoplastic encephalomyelitis (Grade 5), Guillain-Barre syndrome, central nervous system inflammation, Chronic inflammatory demyelinating polyradiculoneuropathy, Encephalitis b, Myasthenia gravis, Neuropathy peripheral.
Maltese: (Grad 4), Enċefalomajelite paraneoplastika (Grad 5), Sindrome ta' Guillain-Barre, infjammazzjoni tas-sistema nervuża ċentrali, poliradikulonewropatija li tiddemijelinizza infjammatorja kronika, Enċefalite b, Myasthenia gravis, Newropatija periferali.
English: The final concentration of the diluted solution should be between 1 mg/ml to 20 mg/ml.
Maltese: Il-konċentrazzjoni finali tas-soluzzjoni ddilwita għandha tkun bejn 1 mg/ml u 20 mg/ml.
English: Among 53 advanced CSCC patients with PD-L1 ≥ 1%, ORR was 54.7% (29/53).
Maltese: Fost 53 pazjent b'CSCC avvanzata b'PD-L1 ≥ 1%, ORR kien 54.7% (29/53).
English: The effect of renal impairment on the exposure of cemiplimab was evaluated by a population PK analysis in patients with mild (CLcr 60 to < 89 ml/min; n= 197), moderate (CLcr 30 to < 60 ml/min; n= 90), or severe (CLcr <30 ml/min; n= 4) renal impairment.
Maltese: L-effet tal-indeboliment tal-kliewi fuq l-esponiment għal cemiplimab ġie stmat permezz ta' analiżi PK ta' popolazzjoni f'pazjenti b'indeboliment ħafif (CLcr 60 sa < 89 ml/min; n= 197), moderat (CLcr 30 sa < 60 ml/min; n= 90), jew sever (CLcr < 30 ml/min; n= 4) tal-kliewi.
English: • Lung problems (pneumonitis)
Maltese: • Problemi fil-pulmun (pulmonite)
English: Musculoskeletal and connective tissue disorders: Myalgia, Arthritis d, Sjogren's syndrome
Maltese: Mijalġja, Artrite d, Sindrome ta' Sjogren
English: Among 54 patients with laCSCC, ORR was 35.3% (6/17) in patients with PD-L1 < 1% and 54.1% (20/37) among patients with PD-L1 ≥ 1%.
Maltese: Fost 54 pazjent b'laCSCC, ORR kien 35.3% (6/17) in patients with f'pazjenti b'PD-L1 < 1% u 54.1% (20/37) fost pazjenti b'PD-L1 ≥ 1%.
English: Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands PD-L1 and
Maltese: Cemiplimab huwa antikorp monoklonali immunoglobulina G4 (IgG4) kompletament uman li jintrabat mar-riċettur ta' mewt ipprogrammat taċ-ċellula 1 (PD-1, programmed cell death-1) u jimblokka l-interazzjoni tiegħu mal-ligands PD-L1 u PD-L2.
English: • The infusion will last about 30 minutes.
Maltese: • L-infużjoni ddum madwar 30 minuta.
English: Cemiplimab is primarily distributed in the vascular system with a volume of distribution at steady-state (Vss) is 5.2 l.
Maltese: Cemiplimab huwa distribwit primarjament fis-sistema vaskulari b'volum ta' disutribuzzjoni fl-istat fiss (Vss, volume of distribution at steady-state) ta' 5.2 l.
English: There are limited data for LIBTAYO in patients with severe renal impairment CLcr <30 ml/min (see section 5.2).
Maltese: Hemm dejta limitata għal LIBTAYO f'pazjenti b'indeboliment sever tal-kliewi CLcr <30 ml/min (ara sezzjoni 5.2).
English: • diarrhoea (loose stools).
Maltese: • dijarea (ippurgar maħlul).
English: The safety of cemiplimab has been evaluated in 591 patients with advanced solid malignancies including 219 advanced CSCC patients who received cemiplimab monotherapy in 2 clinical studies (R2810-ONC-1423 and R2810-ONC-1540).
Maltese: Is-sigurtà ta' cemiplimab ġiet evalwata f'591 pazjent b'tumuri malinni solidi avvanzati inklużi 219-il pazjent b'CSCC avanzata li rċivew monoterapija b'cemiplimab f'2 studji kliniċi (R2810-ONC-1423 u R2810-ONC-1540).
English: Concentration data were collected in 548 patients with various solid tumours, including 178 patients with CSCC, who received cemiplimab.
Maltese: Data ta' konċentrazzjoni nġabret f'548 patients b'diversi tumuri solidi, inklużi 178 pazjent b'CSCC, li rċivew cemiplimab.
English: Adverse reactions were serious in 8.6% patients and led to permanent discontinuation of cemiplimab in 5.8% of patients.
Maltese: Reazzjonijiet avversi kienu serji fi 8.6% tal-pazjenti u wasslu għall-waqfien permanenti ta' cemiplimab f'5.8% tal-pazjenti.