FrancophonIA/ELRC3.0 huggingface dataset:
English: (including but not limited to meningitis, paraneoplastic encephalomyelitis, arthritis, Guillain-Barre syndrome, encephalitis, chronic inflammatory demyelinating polyradiculoneuropathy, central nervous system inflammation, autoimmune myocarditis, and immune thrombocytopenic purpura, myalgia, Sjogren's syndrome, vasculitis, myasthenia gravis)b
Maltese: (inklużi iżda mhux limitati għal meninġite, enċefalomijelite paraneoplastika, artrite, sindrome ta' Guillain-Barre, enċefalite, poliradikulonewropatija infjammatorja kronika li tiddemijelinizza, infjammazzjoni fis-sistema nervuża ċentrali, mijokardite awtoimmuni, u purpura tromboċitopenika immuni, mijalġja, sindrome ta' Sjogren, vaskulite, myasthenia gravis)b
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali.
English: Cardiac Disorders: Myocarditis c, Pericarditis
Maltese: Disturbi fil-qalb: Mijokarditec, Perikardite
English: A total of 161 (83.4 %) patients were male, and 187 (96.9%) patients were White; the ECOG performance score was 0 (44.6%) or 1 (55.4%).
Maltese: Total ta' 161 (83.4 %) pazjent kienu rġiel, u 187 (96.9%) pazjent kienu Bojod; il-punteġġ ta' eżekuzzjoni ta' ECOG kien 0 (44.6%) jew 1 (55.4%).
English: The most common immune-related adverse reactions were hypothyroidism (7.1%), pneumonitis (3.7%), immune-related skin adverse reactions (2.0%), hyperthyroidism (1.9%) and hepatitis (1.9%) (see “Description of selected adverse reactions” below, Special warnings and precautions for use in section 4.4 and Recommended treatment modifications in section 4.2).
Maltese: L-aktar reazzjonijiet avversi komuni marbuta mal-immunità kienu ipotirojdiżmu (7.1%), pulmonite (3.7%), reazzjonijiet avversi marbuta mal-immunità fil-ġilda (2.0%), ipertirojdiżmu (1.9%) u epatite (1.9%) (ara “Deskrizzjoni ta' għażla ta' reazzjonijiet avversi” taħt, Twissijiet u prekawzjonijiet dwar l-użu f'sezzjoni 4.4 u Modifikazzjonijiet irrakkomandati fit-trattament f'sezzjoni 4.2).
English: Hepatobiliary disorders Hepatitis f
Maltese: Disturbi fil-fwied u fil-marrara Epatite f
English: Cemiplimab has not been studied in patients with CLcr <25 ml/min (see section 4.2).
Maltese: Cemiplimab ma ġiex studjat f'pazjenti bi CLcr <25 ml/min (ara sezzjoni 4.2).
English: • Withdraw 7 ml (350 mg) from the vial of LIBTAYO and transfer into an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Maltese: • Iġbed 7 ml (350 mg) mill-kunjett ta' LIBTAYO u ttrasferixxi ġo borża tal-infużjoni għal ġol-vini li jkun fiha soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride jew soluzzjoni għall-injezzjoni ta' 50 mg/ml (5%) glucose.
English: Excipients: L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, sucrose, and water for injections.
Maltese: L-histidine, L-histidine monohydrochloride monohydrate, L-proline, polysorbate 80, sucrose, u ilma għall-injezzjonijiet.
English: Of these 193 patients, 115 had mCSCC and 78 had laCSCC.
Maltese: Minn dawn il-193 pazjent, 115 kellhom mCSCC u 78 kellhom laCSCC.
English: Arthritis is a composite term that includes arthritis and polyarthritis.
Maltese: Artrite huwa terminu kompost li jiġbor fih artrite u polijartrite.
English: Immune-related adverse reactions occurred in 20.1% of patients treated with cemiplimab in clinical trials including Grade 5 (0.7%), Grade 4 (1.2%) and Grade 3 (6.1%).
Maltese: Reazzjonijiet avversi marbuta mal-immunità seħħew f'20.1% tal-pazjenti ttrattati b'cemiplimab fi provi kliniċi inklużi ta' Grad 5 (0.7%), Grad 4 (1.2%) u Grad 3 (6.1%).
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma ddefiniti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax titieħed stima mid-data disponibbli).
English: Severitya
Maltese: Severitàa
English: Secondary endpoints were duration of response (DOR) by ICR and by investigator assessment (IA), ORR by IA, progression free survival (PFS) by ICR and IA, overall survival (OS), complete response rate (CRR) by ICR, and change in scores in patient reported outcomes on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30).
Maltese: L-iskopijiet finali sekondarji kienu t-tul ta' żmien tar-rispons (DOR, duration of response) permezz ta' ICR u bi stima tal-investigatur (IA, investigator assessment), ORR permezz ta' IA, sopravivenza mingħajr progressjoni (PFS, progression free survival) permezz ta' ICR u IA, sopravivenza totali (OS, overall survival), rata sħiħa ta' rispons (CRR, complete response rate) permezz ta' ICR, u bidla fil-punteġġi f'riżultati rrappurtati mill-pazjenti fuq il-Kwestjonarju dwar il-Kwalità tal-Ħajja tal-Organizzazzjoni Ewropea dwar ir-Riċerka u t-Trattament tal-Kanċer (EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire).
English: Tabulated list of adverse reactions in patients treated with cemiplimab System organ class preferred term
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella f'pazjenti ttrattati b'cemiplimab Terminu preferut tal-klassi tas-sistemi u tal-organi
English: Version v.4.03 of NCI CTCAE was used to grade toxicity.
Maltese: Intużat il-verżjoni v.4.03 ta' NCI CTCAE biex jingħataw il-gradi ta' tossiċità.
English: • rash, itching
Maltese: • raxx, ħakk
English: Immune thrombocytopenic purpura
Maltese: Purpura tromboċitopenika immuni
English: Immune-related adverse reactions led to permanent discontinuation of cemiplimab in 4.4% of patients.
Maltese: Reazzjonijiet avversi marbuta mal-immunità wasslu għall-waqfien permanenti ta' cemiplimab f'4.4% tal-pazjenti.
English: The primary endpoint of Study 1540 was confirmed objective response rate (ORR), as assessed by independent central review (ICR).
Maltese: L-iskop finali primarju tal-Istudju 1540 kien konferma tar-rata oġġettiva ta' rispons (ORR, objective response rate), kif stmata minn reviżjoni ċentrali indipendenti (ICR, independent central review).
English: Endocrine disorders Hypothyroidism
Maltese: Disturbi fis-sistema endokrinarja Ipotirojdiżmu
English: Clinical activity was observed regardless of tumour PD-L1 expression status.
Maltese: Attività klinika ġiet osservata irrispettivament mill-istat ta' espressjoni ta' PD-L1 tat-tumur.
English: Data cut-off was Sep 20, 2018 for Groups 1 and 3 patients, and Oct 10, 2018 for Group 2 patients.
Maltese: Iż-żmien meta waqfet tinġabar id-data kien l-20 ta' Settembru, 2018 għall-pazjenti tal-Gruppi 1 u 3, u l-10 ta' Ottubru, 2018 għall-pazjenti ta' Grupp 2.
English: No clinical data are available on the possible effects of cemiplimab on fertility.
Maltese: Ma hija disponibbli l-ebda data klinika dwar l-effetti possibbli ta' cemiplimab fuq il-fertilità.
English: In the 193 patients in the efficacy analysis, the objective response rate by ICR (95% CI) was 40.8% (27.0%, 55.8%) in patients less than 65 years, 48.5% (36.0%, 61.1%) in patients 65 to less than 75 years, and 42.3% (31.2%, 54.0%) in patients 75 years or older.
Maltese: Fil-193 pazjent fl-analiżi ta' effikaċja, ir-rata oġġettiva ta' rispons permezz ta' ICR (95% CI) kienet 40.8% (27.0%, 55.8%) f'pazjenti li kellhom anqas minn 65 sena, 48.5% (36.0%, 61.1%) f'pazjenti minn 65 sa inqas minn 75 sena, u 42.3% (31.2%, 54.0%) f'pazjenti ta' 75 sena jew aktar.
English: Overall survival does not require central review.
Maltese: Sopravivenza totali ma teħtieġx reviżjoni ċentrali.
English: Based on Kaplan Meier estimates d.
Maltese: Abbażi tal-istimi Kaplan Meier d.
English: Among 21 mCSCC patients, ORR was 60% (3/5) in patients with PD-L1 < 1% and 56.3% (9/16) among patients with PD-L1 ≥ 1%.
Maltese: Fost 21 pazjent b'mCSCC, ORR kienet 60% (3/5) f'pazjenti b'PD-L1 < 1% u 56.3% (9/16) fost pazjenti b'PD-L1 ≥ 1%.
English: Pericarditis
Maltese: Perikardite
English: • Kidney problems (nephritis and kidney failure)
Maltese: • Problemi fil-kliewi (nefrite u insuffiċjenza tal-kliewi)
English: • thyroid gland problems
Maltese: • problemi fil-glandola tat-tirojde
English: Patients excluded from clinical studies
Maltese: Pazjenti esklużi mill-provi kliniċi
English: • Gut problems (colitis)
Maltese: • Problemi fl-intern (kolite)
English: Clear to slightly opalescent, colourless to pale yellow solution with a pH of 6.0 and osmolality between 300 and 360 mmol/kg.
Maltese: Soluzzjoni ċara sa kemxejn tkanġi, bla kulur sa safra ċara b'pH ta' 6.0 u osmolalità bejn 300 u 360 mmol/kg.
English: concentrate for solution for infusion 350 mg/7 ml
Maltese: konċentrat għal soluzzjoni għall-infużjoni 350 mg/7 ml
English: The efficacy and safety of cemiplimab in patients with metastatic (nodal or distant) CSCC (mCSCC) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation were studied in clinical trial R2810-ONC-1540 (Study 1540).
Maltese: L-effikaċja u s-sigurtà ta' cemiplimab f'pazjenti b'CSCC metastatika (fl-għoqiedi jew bogħod mis-sors) (mCSCC) jew CSCC avvanzata b'mod lokali (laCSCC) li ma kinux kandidati għal-operazzjoni bħala kura jew radjazzjoni bħala kura ġew studjati fi prova klinika R2810-ONC-1540 (Studju 1540).
English: Median follow-up was 16.5 months for the mCSCC 3 mg/kg every 2 weeks group, 9.3 months for the laCSCC 3 mg/kg every 2 weeks group and 8.1 months for the mCSCC 350 mg every 3 weeks group.
Maltese: Is-segwitu medjan kien ta' 16.5 xhur għall-grupp mCSCC 3 mg/kg kull ġimagħtejn, 9.3 xhur għall-grupp laCSCC 3 mg/kg kull ġimagħtejn u 8.1 xhur għall-grupp mCSCC 350 mg kull 3 ġimgħat.
English: Median (range) (months)
Maltese: Medjan (firxa) (xhur)
English: Rash is a composite term that includes rash maculo-papular, rash, dermatitis, rash generalised, dermatitis bullous, drug eruption, erythema, pemphigoid, psoriasis, rash erythematous, rash macular, rash pruritic and skin reaction.
Maltese: Raxx huwa terminu kompost li jiġbor fih raxx makulopapulari, raxx, dermatite, raxx mifrux, dermatite bl-infafet, dehra f'daqqa ta' raxx fil-ġilda minħabba l-mediċina, eritema, pemfigojd, psorjażi, raxx eritematuż, raxx makulari, raxx bil-ħakk u reazzjoni fil-ġilda.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati l-PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Five out of 398 patients (1.3%) administered cemiplimab developed treatment-emergent antibodies, with 1 out of 398 patients (0.3%) exhibiting persistent antibody responses.
Maltese: Ħamsa minn 398 pazjent (1.3%) li ngħataw cemiplimab żviluppaw antikorpi li fiġġu minħabba t-trattament, b'pazjent 1 minn 398 pazjent (0.3%) li wera risponsi persistenti ta' antikorpi.
English: In patients with mild hepatic impairment (n= 5) (total bilirubin [TB] greater than 1.0 to 1.5 times the upper limit of normal [ULN] and any aspartate aminotransferase [AST]); no clinically important differences in the exposure of cemiplimab were found compared to patients with normal hepatic function.
Maltese: F'pazjenti b'indeboliment ħafif tal-fwied (n= 5) (bilirubin totali [TB, total bilirubin] aktar minn 1.0 sa 1.5 drabi aktar mil-limitu ta' fuq tan-normal [ULN, upper limit of normal] u kwalunkwe aspartate aminotransferase [AST, aspartate aminotransferase]); ma nstabu l-ebda differenzi importanti b'mod kliniku fl-esponiment għal cemiplimab meta mqabbla ma' pazjenti b'funzjoni normali tal-fwied. Cemiplimab ma ġiex studjat f'pazjenti b'indeboliment moderat jew sever tal-fwied.
English: Nervous system disorders Paraneoplastic encephalomyelitis
Maltese: Disturbi fis-sistema nervuża Enċefalomijelite paraneoplastika
English: • inflammation of the pituitary gland situated at the base of the brain; decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid
Maltese: • infjammazzjoni tal-glandola pitwitarja li qegħda fil-bażi tal-moħħ; tnaqqis fir-reħi ta' ormoni li jipproduċu l-glandoli adrenali; infjammazzjoni tat-tirojde
English: ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
Maltese: ALT: alanine aminotransferase;
English: Cases of SJS, fatal TEN and stomatitis occurred following 1 dose of cemiplimab in patients with prior exposure to idelalisib, who were participating in a clinical trial evaluating cemiplimab in Non-Hodgkin Lymphoma (NHL), and who had recent exposure to sulfa containing antibiotics (see section 4.8).
Maltese: Każijiet ta' SJS, TEN fatali u stomatite seħħew wara doża waħda ta' cemiplimab f'pazjenti b'esponiment preċedenti għal idelalisib, li kienu qed jipparteċipaw fi prova klinika biex tevalwa cemiplimab f'Limfoma mhux ta' Hodgkin (NHL, Non-Hodgkin Lymphoma), u li kellhom esponiment riċenti għal antibiotiċi li kien fihom sulfa (ara sezzjoni 4.8).
English: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with cemiplimab treatment (see section 4.4).
Maltese: Reazzjonijiet avversi kutanji severi (SCARs, severe cutaneous adverse reactions), inklużi sindrome ta' Stevens-Johnson (SJS, Stevens-Johnson syndrome) u nekroliżi tossika tal-epidermide (TEN, toxic epidermal necrolysis) kienu rrappurtati b'rabta mat-trattament b'cemiplimab (ara sezzjoni 4.4).
English: Withhold LIBTAYO
Maltese: X'fih LIBTAYO
English: • Liver problems (hepatitis)
Maltese: • Problemi fil-fwied (epatite)
English: Very common Musculoskeletal and connective tissue disorders Arthralgia
Maltese: Komuni ħafna Disturbi muskoluskeletriċi u tat-tessuti konnettivi Artralġja
English: Results are presented from 193 patients in Study 1540.
Maltese: Ir-riżultati huma ppreżentati minn 193 pazjent fl-Istudju 1540.
English: With 350 mg every 3 weeks, the mean steady-state concentration of cemiplimab ranged between Cmax of 168 mg/l and a Ctrough of 61 mg/l.
Maltese: B'350 mg kull 3 ġimgħat, il-konċentrazzjoni medja ta' cemiplimab fl-istat fiss kienet fuq firxa bejn Cmax ta' 168 mg/l u Ctrough ta' 61 mg/l.
English: CI: confidence interval; ICR: Independent Central Review; NR: Not Reached; +: Denotes ongoing at last assessment a.
Maltese: CI: intervall ta' kunfidenza (Confidence Interval); ICR: Reviżjoni
English: Other medicines and LIBTAYO
Maltese: Mediċini oħra u LIBTAYO
English: Severe and fatal immune-related adverse reactions have been observed with cemiplimab (see section 4.8).
Maltese: Reazzjonijiet avversi severi u fatali marbuta mal-immunità ġew oservati b'cemiplimab (ara sezzjoni 4.8).
English: Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above
Maltese: Sinjali u sintomi kliniċi ta' Grad 3 ta' reazzjoni avversa marbuta mal-immunità mhux deskritta fuq
English: • Hormone gland problems - especially thyroid, pituitary, adrenal glands and the pancreas
Maltese: • Problemi bil-glandoli tal-ormoni - speċjalment il-glandola tat-tirojde, pitwitarja, il-glandoli adrenali u l-frixa
English: Among patients with mCSCC, 76.5% had distant metastases, and 22.6% had only nodal metastases.
Maltese: Fost il-pazjenti b'mCSCC, 76.5% kellhom metastasi bogħod mis-sors, u 22.6% kellhom metastasti fl-għoqiedi biss.
English: Immune-related adverse reactions (see section 4.4) Immune-related pneumonitis
Maltese: Reazzjonijiet avversi marbuta mal-immunità (ara sezzjoni 4.4)
English: The recommended dose is 350 mg cemiplimab, every 3 weeks, administered as an intravenous infusion over 30 minutes.
Maltese: Id-doża rrakkomandata hija 350 mg cemiplimab, kull 3 ġimgħat, mogħtija bħala infużjoni fil-vini fuq perjodu ta' 30 minuta.
English: Uncommon Respiratory, thoracic and mediastinal disorders Pneumonitis
Maltese: Mhux komuni Disturbi respiratorji, toraċiċi u medjastinali Pulmonite
English: Duration of response (DOR)
Maltese: Tul ta' żmien tar-rispons (DOR, Duration of Response)
English: Severity a
Maltese: Meninġite a
English: This leaflet was last revised in June 2019.
Maltese: Dan il-fuljett kien rivedut l-aħħar f'Ġunju 2019.
English: Of the 219 patients with mCSCC and laCSCC treated with cemiplimab, 25.1% (55/219) were less than 65 years, 34.2% (75/219) were 65 to less than 75 years, and 40.6% (89/219) were 75 years or older.
Maltese: 1% (55/219) kellhom anqas minn 65 sena, 34.2% (75/219) kellhom minn 65 sa inqas minn 75 sena, u 40.6% (89/219) kellhom 75 sena jew aktar.
English: - Grade 4 adverse reaction (excluding endocrinopathies) - Recurrent severe Grade 3 immune-related adverse reaction - Persistent Grade 2 or 3 immune-related adverse reactions lasting 12 weeks or longer (excluding endocrinopathies) - Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks
Maltese: - Reazzjoni avversa ta' Grad 4 (minbarra endokrinopatiji) - Reazzjoni avversa rikurrenti, severa ta' Grad 3 marbuta mal-immunità - Reazzjonijiet avversi persistenti ta' Grad 2 jew 3 marbuta mal-immunità li jdumu 12-il ġimgħa jew aktar (minbarra endokrinopatiji) - Inabbiltà li tnaqqas id-doża tal-kortikosterojd għal 10 mg jew anqas ta' prednisone jew ekwivalenti kuljum fi żmien 12-il ġimgħa
English: Marketing Authorisation Holder Regeneron Ireland Designated Activity Company (DAC) Europa House
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Regeneron Ireland Designated Activity Company (DAC) Europa House
English: Neuropathy peripheral is a composite term that includes neuropathy peripheral and neuritis.
Maltese: Newropatija periferali huwa terminu kompost li jiġbor fih newropatija periferali u nevrite.
English: Tel: +39 02 39394275
Maltese: Sanofi S.p.A Tel: +39 02 39394275
English: For patients with externally visible target lesions (locally advanced CSCC and metastatic CSCC), ORR was determined by a composite endpoint that integrated ICR assessments of radiologic data (RECIST 1.1) and digital medical photography (WHO criteria).
Maltese: Għall-pazjenti b'feriti li jidhru minn barra fil-mira (CSCC avvanzat b'mod lokali u CSCC metastatiku), ORR ġie determinat permezz ta' skop finali kompost li għaqqad fih l-istimi ICR ta' data radjuloġika (RECIST 1.1) u fotografija diġitali medika (kriterji tal-WHO).
English: This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14a(4) tar-Regolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Immune-related endocrinopathies
Maltese: Endokrinopatiji marbuta mal-immunità
English: Renal and urinary disorders Nephritis
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Nephritis
English: Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated
Maltese: 2 mg/kg/jum prednisone jew ekwivalenti segwita minn tnaqqis bil-mod il-mod u sostituzzjoni tal-ormoni skont kif indikat b'mod kliniku
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: • at room temperature up to 25°C for no more than 8 hours from the time of preparation.
Maltese: • f'temperatura ambjentali sa 25°C għal mhux aktar minn 8 sigħat mill-ħin tal-preparazzjoni.
English: Patients with any of the following were excluded: autoimmune disease that required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; history of pneumonitis within the last 5 years; prior treatment with anti-PD-1/PD-L1 or other immune checkpoint inhibitor therapy; active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus; chronic lymphocytic leukaemia (CLL); brain metastases or Eastern Cooperative Oncology Group (ECOG) performance score ≥ 2.
Maltese: PD-1/PD-L1 jew terapija oħra li tinibixxi checkpoint immuni; infezzjoni attiva li teħtieġ terapija, inkluża infezzjoni magħruda bil-virus tal-immunodefiċjenza umana, jew infezzjoni attiva bil-virus tal-epatite B jew epatite C; lewkimja limfoċitika kronika (CLL, chronic lymphocytic leukemia); metastasi fil-moħħ jew punteġġ ta' eżekuzzjoni ≥ 2 tal-Koperattiva tal-Grupp ta' Onkoloġija tal-Lvant (ECOG, Eastern Cooperative Oncology Group).
English: b Observed with LIBTAYO or with other anti-PD-1/PD-L1 monoclonal antibodies
Maltese: b Osservati b'LIBTAYO jew b'antikorpi monoklonali kontra
English: Preparation
Maltese: Preparazzjoni
English: Immune-related skin adverse reactions, defined as requiring use of systemic corticosteroids with no clear alternate aetiology, including severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (some cases with fatal outcome), and other skin reactions such as rash, erythema multiforme, pemphigoid, have been reported in association with cemiplimab treatment (see section 4.8).
Maltese: Reazzjonijiet avversi fil-ġilda marbuta mal-immunità, iddefiniti bħala dawk li jeħtieġu l-użu ta' kortikosterojdi sistemiċi mingħajr l-ebda etjoloġija alternattiva ċara, inklużi reazzjonijiet avversi kutanji severi (SCARs, severe cutaneous adverse reactions), bħas-Sindrome ta' Stevens-Johnson (SJS, Stevens-Johnson syndrome) u nekroliżi tossika tal-epidermide (TEN, toxic epidermal necrolysis) (xi każijiet b'riżultat fatali), u reazzjonijiet oħra fil-ġilda bħal raxx, eritema multiforme, pemfigojd, ġew irrappurtati b'assoċjazzjoni mat-trattament b'cemiplimab (ara sezzjoni 4.8).
English: Concentrate for solution for infusion (sterile concentrate).
Maltese: Konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili).
English: What LIBTAYO contains The active substance is cemiplimab:
Maltese: Is-sustanza attiva hija cemiplimab:
English: Alanine aminotransferase increased Common Aspartate aminotransferase increased Common Blood alkaline phosphatase increased Common Blood creatinine increased
Maltese: Komuni Żieda fl-aspartate aminotransferase Komuni
English: • cough, inflammation of the lungs
Maltese: • sogħla, infjammazzjoni fil-pulmuni
English: • under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion preparation.
Maltese: • fil-friġġ f'temperatura minn 2°C sa 8°C għal mhux aktar minn 24 siegħa mill-ħin tal-preparazzjoni tal-infużjoni.
English: • you have had an organ transplant
Maltese: • inti kellek trapjant ta' organu
English: How to store LIBTAYO 6.
Maltese: Kif taħżen LIBTAYO 6.
English: Thirty-three and 7/10 per cent (33.7%) of patients had received at least 1 prior anti-cancer systemic therapy, 90.2% of patients had received prior cancer related surgery, and 67.9% of patients had received prior radiotherapy.
Maltese: Tlieta u tletin u 7/10 fil-mija (33.7%) tal-pazjenti kienu rċivew mill-inqas terapija sistemika waħda preċedenti kontra l-kanċer, 90.2% tal-pazjenti kienu rċivew operazzjoni preċedenti marbuta mal-kanċer, u 67.9% tal-pazjenti kienu rċivew radjuterapija preċedenti.
English: LIBTAYO is an anti-cancer medicine that contains the active substance cemiplimab, which is a monoclonal antibody.
Maltese: LIBTAYO huwa mediċina kontra l-kanċer li fih is-sustanza attiva cemiplimab, li huwa antikorp monoklonali.