FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be managed with hormone replacement therapy (if indicated) and cemiplimab treatment modifications.
Maltese: Il-pazjenti għandhom jiġu mmaniġjati b'terapija ta' sostituzzjoni tal-ormoni (jekk ikun indikat) u b'modifikazzjonijiet fit-trattament b'cemiplimab.
English: The median age was 72 years (range: 38 to 96): Seventy-eight (40.4%) patients were 75 years or older, 66 patients (34.2%) were 65 to less than 75 years, and 49 patients (25.4%) were less than 65 years.
Maltese: Iż-żmien medjan kien 72 sena (firxa: 38 sa 96): Tmienja u sebgħin pazjent (40.4%) kellhom 75 sena u aktar, 66 pazjent (34.2%) kellhom minn 65 sa inqas minn 75 sena, u 49 pazjent (25.4%) kellhom inqas minn 65 sena.
English: Chronic inflammatory demyelinating polyradiculoneuropathy
Maltese: Poliradikulonewropatija infjammatorja kronika li tiddemijelinizza
English: Encephalitis
Maltese: Enċefalite
English: Grade 2 to 4
Maltese: Grad 2 jew 4
English: o Description of the main signs or symptoms of the immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, nephritis and other irARs) and infusion related reactions, and the importance of notifying their treating physician immediately if symptoms occur.
Maltese: o Deskrizzjoni tas-sinjali jew is-sintomi prinċipali ta' reazzjonijiet avversi marbuta mal-immunità (pulmonite, kolite, epatite, endokrinopatiji, reazzjonijiet avversi fil-ġilda marbuta mal-immunità, nefrite u irARs oħra) u reazzjonijiet marbuta mal-infużjoni, u l-importanza li javżaw lit-tabib li qed jittrattahom immedjatament jekk iseħħu s-sintomi.
English: Look out for side effects
Maltese: Oqgħod attent/a għal effetti sekondarji
English: Immune-related hepatitis occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 5, 1 (0.2%) patient with Grade 4, and 9 (1.5%) patients with Grade 3 immune-related hepatitis.
Maltese: Epatite marbuta mal-immunità seħħet fi 11 (1.9%) minn 591 pazjent li kienu qed jirċievu cemiplimab inkluż pazjent 1 (0.2%) b'epatite marbuta mal-immunità ta' Grad 5, pazjent 1 (0.2%) bi Grad 4, u 9 (1.5%) pazjenti bi Grad 3. Epatite marbuta mal-immunità wasslet għal waqfien permanenti ta' cemiplimab f'5 (0.8%) minn 591 pazjent.
English: For patients with metastatic CSCC without externally visible target lesions, ORR was determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Maltese: Għall-pazjenti b'CSCC metastatika mingħajr feriti li jidhru fuq barra fil-mira, ORR ġie determinat permezz tal-Kriterji ta' Valutazzjoni tar-Rispons f'Tumuri Solidi (RECIST 1.1, Response Evaluation Criteria in Solid Tumours).
English: As with all therapeutic proteins, there is a potential for immunogenicity with cemiplimab.
Maltese: Bħal ma jiġri bil-proteini terapewtiċi kollha, hemm il-possibbiltà ta' immunoġeniċità b'cemiplimab.
English: Date of first authorisation: 28 June 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 28 Ġunju 2019
English: Eye disorders: Keratitis Gastrointestinal disorders: Stomatitis a includes meningitis and meningitis aseptic b includes encephalitis and noninfective encephalitis c includes autoimmune myocarditis and myocarditis d includes arthritis and polyarthritis
Maltese: Stomatite a tinkludi meningite u meninġite asettika b tinkludi enċefalite u enċefalite mhux infettiva c tinkludi mijokardite awtoimmuni u mijokardite d tinkludi artrite u polijartrite
English: See section 4.8 for how to report adverse reactions.
Maltese: Ara sezzjoni 4.8 dwar kif għandhom jiġu rrappurtati reazzjonijiet avversi.
English: Initiate symptomatic management immediately, including initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Maltese: Ibda' immaniġġjar tas-sintomi immedjatament, inkluża doża inizjali ta' 1 sa 2 mg/kg/jum prednisone jew ekwivalenti segwita
English: Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing foetus resulting in foetal death (see section 5.3).
Maltese: Studji f'annimali urew li inibizzjoni tas-sensiela ta' reazzjonijiet ta' PD-1/PD-L1 tista' twassal għal żieda fir-riskju ta' rifjut medjat mis-sistema immuni tal-fetu li qed jiżviluppa li twassal għall-mewt tal-fetu (ara sezzjoni 5.3).
English: Immune-related adverse reactions should be managed with cemiplimab treatment modifications, hormone replacement therapy (if clinically indicated), and corticosteroids.
Maltese: Reazzjonijiet avversi marbuta mal-immunità għandhom jiġu mmaniġġjati b'modifikazzjonijiet fit-trattament b'cemiplimab, terapija b'sostituzzjoni tal-ormoni (jekk ikun indikat b'mod kliniku), u kortikosterojdi.
English: Immune-related colitis
Maltese: Kolite marbuta mal-immunità
English: Immune-related nephritis
Maltese: Nefrite marbuta mal-immunità
English: Animal reproduction studies have not been conducted with cemiplimab (see section 4.6).
Maltese: Ma sarux studji ta' riproduzzjoni fl-annimali b'cemiplimab (ara sezzjoni 4.6).
English: The recommended dose of LIBTAYO is 350 mg.
Maltese: Id-doża rrakkomandata ta' LIBTAYO hija 350 mg.
English: Immune-related nephritis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Maltese: Nefrite marbuta mal-immunità wasslet għall-waqfien permanenti ta' cemiplimab f'pazjent 1 (0.2%) minn 591 pazjent.
English: Grade 3 or 4 (excluding endocrinopathies) or recurrent Grade 2
Maltese: Grad 3 jew 4 (minbarra endokrinopatiji) jew Grad 2 rikurrenti
English: No clinically important differences in the exposure of cemiplimab were found between patients with renal impairment and patients with normal renal function.
Maltese: Ma nstabu l-ebda differenzi importanti b'mod kliniku fl-esponiment għal cemiplimab bejn pazjenti b'indeboliment tal-kliewi u pazjenti b'funzjoni normali tal-kliewi.
English: Immune-related type 1 diabetes mellitus, including diabetic ketoacidosis, has been observed in patients receiving cemiplimab (see section 4.8).
Maltese: Dijabete mellitus tat-tip 1 marbuta mal-immunità, inkluża ketoaċidożi tad-dijabete, ġiet osservata f'pazjenti li kienu qed jirċievu cemiplimab (ara sezzjoni 4.8).
English: Infusion-related reaction led to permanent discontinuation of cemiplimab in 2 (0.3%) patients.
Maltese: Reazzjoni marbuta mal-infużjoni wasslet għall-waqfien permanenti ta' cemiplimab f'2 (0.3%) pazjenti.
English: Immune-related pneumonitis occurred in 22 (3.7%) of 591 patients receiving cemiplimab, including 2 (0.3%) patients with Grade 5, 2 (0.3%) patients with Grade 4, and 6 (1.0%) patients with Grade 3 pneumonitis.
Maltese: Pulmonite marbuta mal-immunità seħħet fi 22 (3.7%) mill-591 pazjent li kienu qed jirċievu cemiplimab, inklużi 2 (0.3%) pazjenti b'pulmonite ta' Grad 5, 2 (0.3%) pazjenti b'pulmonite ta' Grad 4, u 6 (1.0%) pazjenti b'pulmonite ta' Grad 3. Pulmonite marbuta mal-immunità wasslet għal waqfien permanenti ta' cemiplimab fi 11 (1.9%) minn 591 pazjent.
English: Fatigue has been reported following treatment with cemiplimab (see section 4.8).
Maltese: Ġiet irrappurtata għeja wara t-trattament b'cemiplimab (ara sezzjoni 4.8).
English: Each carton contains 1 vial.
Maltese: Kull kartuna fiha kunjett 1.
English: Pruritus h
Maltese: Ħakk h
English: For a full list of patients excluded from clinical trials, see section 5.1.
Maltese: Għal-lista sħiħa ta' pazjenti li ġew esklużi mill-provi kliniċi, ara sezzjoni 5
English: Infusion-related reactions occurred in 54 (9.1%) of 591 patients treated with cemiplimab including 1 (0.2%) patient with Grade 3 infusion-related reaction.
Maltese: Reazzjonijiet marbuta mal-infużjoni seħħew f'54 (9.1%) minn 591 pazjent ittrattati b'cemiplimab inkluż pazjent 1 (0.2%) b'reazzjoni marbuta mal-infużjoni ta' Grad 3.
English: Immune-related nephritis occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 2 (0.3%) patients with Grade 3 immune-related nephritis.
Maltese: Nefrite marbuta mal-immunità seħħet fi 3 (0.5%) minn 591 pazjent li kienu qed jirċievu cemiplimab inkluż 2 (0.3%) pazjenti b'nefrite marbuta mal-immunità ta' Grad 3.
English: Grades 3-5
Maltese: Gradi 1-5 (%) Gradi 3-5 (%)
English: It is known that antibodies (including IgG4) are secreted in human milk; a risk to the breast-feeding newborns/infants cannot be excluded.
Maltese: Huwa magħruf li antikorpi (inklużi IgG4) jiġu eliminati mill-ħalib tas-sider tal-bniedem; riskju gћat-trabi tat-twelid/trabi li qed jitreddgħu mhux eskluż.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Among the 3 patients with immune-related nephritis, the median time to onset was 1.8 months (range: 29 days to 4.1 months) and the median duration of nephritis was 18 days (range: 9 days to 29 days).
Maltese: Fost it-3 pazjenti b'nefrite marbuta mal-immunità, iż-żmien medjan għall-bidu kien 1.8 xhur (firxa: 29 jum sa 4.1 xhur) u t-tul medjan ta' żmien ta' nefrite kien 18-il jum (firxa: 9 ijiem sa 29 jum).
English: Time to response Median (months) range (min:max)
Maltese: Medjan (xhur) firxa (min:mass)
English: • Periodic safety update reports (PSURs)
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà (PSURs)
English: The selected adverse reactions described below are based on safety of cemiplimab in 591 patients in uncontrolled clinical studies.
Maltese: Ir-reazzjonijiet avversi magħżula deskritti taħt huma bbażati fuq is-sigurtà ta' cemiplimab f'591 pazjent fi studji kliniċi mhux ikkontrollati.
English: Among the 22 patients with immune-related pneumonitis, the median time to onset was 3.8 months (range: 7 days to 18 months) and the median duration of pneumonitis was 21.5 days (range: 5 days to 6.5 months).
Maltese: Fost it-22 pazjent b'pulmonite marbuta mal-immunità, iż-żmien medjan għall-bidu tagħha kien 3.8 xhur (firxa: 7 ijiem sa 18-il xahar) u l-medjan tat-tul ta' żmien tal-pulmonite kien 21.5 jum (firxa: 5 ijiem sa 6.5 xhur).
English: One ml of concentrate contains 50 mg of cemiplimab.
Maltese: U KWANTITATTIVA Millilitru ta' konċentrat fih 50 mg ta' cemiplimab.
English: The safety and efficacy of LIBTAYO in children and adolescents below the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' LIBTAYO fi tfal u adolexxenti taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Type 1 diabetes mellitus without an alternative aetiology occurred in 4 (0.7%) of 591 patients including 3 (0.5%) patients with Grade 4 and 1 (0.2%) patient with Grade 3 type 1 diabetes mellitus.
Maltese: Dijabete mellitus tat-tip 1 mingħajr etjoloġija alternattiva seħħet f'4 (0.7%) minn 591 pazjent inklużi 3 (0.5%) pazjenti bi Grad 4 u pazjent 1 (0.2%) bi Grad 3 ta'dijabete mellitus tat-tip 1.
English: Tel: +40 (0) 21 317 31 36
Maltese: Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
English: Efficacy and PD-L1 status
Maltese: Effikaċja u stat ta' PD-L1:
English: Cardiac disorders Myocarditis d
Maltese: Disturbi fil-qalb Mijokardite d
English: Resolution of hepatitis had occurred in 8 (72.7%) of the 11 patients at the time of data cut-off.
Maltese: Fejqan tal-epatite kien seħħ fi 8 (72.7%) mill-11-il pazjent fiż-żmien meta waqfet tinġabar id-data.
English: LIBTAYO is used in adults to treat a type of skin cancer called advanced cutaneous squamous cell carcinoma or CSCC.
Maltese: LIBTAYO jituża fl-adulti biex jitratta tip ta' kanċer tal-ġilda fl-adulti msejjaħ karċinoma kutanja avvanzata taċ-ċelluli skwamużi jew CSCC (advanced cutaneous squamous cell carcinoma).
English: Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Maltese: Grad 2 li jdum aktar minn ġimgħa, Grad 3 jew suspett ta' Sindrome ta' Stevens-Johnson (SJS, Stevens-Johnson syndrome) jew nekroliżi tossika tal-epiderme (TEN, toxic epidermal necrolysis)
English: • Skin problems
Maltese: • Problemi fil-ġilda
English: Grade 2 or 3
Maltese: Grad 2 jew 3
English: Similar exposures to cemiplimab are achieved with the doses of 350 mg every 3 weeks and 3 mg/kg every 2 weeks.
Maltese: Esponimenti jixxiebhu għal cemiplimab inkisbu bid-dożi ta' 350 mg kull 3 ġimgħat u 3 mg/kg kull ġimagħtejn.
English: At dosing regimens of 1 mg/kg to 10 mg/kg every 2 weeks and 350 mg every 3 weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway over the dosing interval.
Maltese: Bi skedi ta' għoti ta' doża ta' 1 mg/kg sa 10 mg/kg kull ġimagħtejn u 350 mg kull 3 ġimgħat, il-kinetika ta' cemiplimab ġiet osservata li hija lineari u fi proporzjon mad-doża, li tissuġġerixxi saturazzjoni tas-sensiela ta' reazzjonijiet medjata mis-sit fil-mira fuq il-perjodu bejn l-għoti tad-dożi.
English: Or
Maltese: JIS
English: The use of systemic corticosteroids or immunosuppressants before starting cemiplimab, except for physiological doses of systemic corticosteroid (≤10 mg/day prednisone or equivalent), should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of cemiplimab.
Maltese: L-użu ta' kortikosterojdi sistemiċi jew immunosoppressanti qabel tibda' cemiplimab, ħlief għal dożi fiżjoloġiċi ta' kortikosterojd sistemiku (≤10 mg/jum prednisone jew ekwivalenti), għandu jiġi evitat minħabba li jista' jinterferixxi mal-attività farmakodinamika u l-effikaċja ta' cemiplimab.
English: • Infusion-related reactions
Maltese: • reazzjonijiet marbuta mal-infużjoni
English: • infusion-related reactions
Maltese: • Reazzjonijiet marbuta mal-infużjoni
English: Immune-related hepatitis
Maltese: Epatite marbuta mal-immunità
English: 6 months
Maltese: 6 xhur
English: Patients should be monitored for signs and symptoms of pneumonitis.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' pulmonite.
English: Depending upon the severity of the adverse reaction, cemiplimab should be withheld or permanently discontinued (see section 4.2).
Maltese: Skont is-severità tar-reazzjoni avversa, cemiplimab għandu jitwaqqaf b'mod temporanju jew permanenti (ara sezzjoni 4.2).
English: • Each vial contains 350 mg cemiplimab in 7 ml of concentrate.
Maltese: • Kull kunjett fih 350 mg ta' cemiplimab f'7 ml ta' konċentrat.
English: Children and adolescents LIBTAYO should not be used in children and adolescents below 18 years of age.
Maltese: Tfal u adolexxenti LIBTAYO m'għandux jintuża fi tfal u adolexxenti taħt l-età ta' 18-il sena.
English: • The patient guide shall contain the following key messages o Description of the main signs or symptoms of the immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, immune-related skin adverse reactions, nephritis and other irARs) and infusion related reactions, and the importance of notifying their treating physician immediately if symptoms occur.
Maltese: • Il-gwida għall-pazjent għandu jkun fiha l-messaġġi l-aktar importanti li ġejjin o Deskrizzjoni tas-sinjali u s-sintomi prinċipali tar-reazzjonijiet avversi marbuta mal-immunità (pulmonite, kolite, epatite, endokrinopatiji, reazzjonijiet avversi fil-ġilda marbuta mal-immunità, nefrite u irARs oħra) u reazzjonijiet marbuta mal-infużjoni, u l-importanza li javżaw lit-tabib li qed jittrattahom immedjatament jekk iseħħu s-sintomi.
English: • LIBTAYO is given as a drip into a vein (intravenous infusion).
Maltese: • LIBTAYO jingħata bħala dripp ġo vina (infużjoni ġol-vini).
English: Nine patients (1.5%) with immune-related skin adverse reactions received high-dose corticosteroids for a median of 16 days (range: 7 days to 2.6 months).
Maltese: Disa' pazjenti (1.5%) b'reazzjonijiet avversi fil-ġilda marbuta mal-immunità rċivew dożi għoljin ta' ta' kortikosterojdi għal medjan ta' 16-il jum (firxa: 7 ijiem sa 2.6 xhur).
English: • LIBTAYO must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
Maltese: • LIBTAYO għandu jingħata permezz ta' infużjoni fil-vini fuq perjodu ta' 30 minuta permezz ta' pajp irqiq ġol-vini li jkollu fih filter sterili, mhux piroġeniku, b'irbit baxx mal-proteini, ġol-pajp innifsu jew imwaħħal miegħu (daqs tal-por 0.2 mikron sa 5 mikron).
English: In Study 1540, patients received cemiplimab until progression of disease, unacceptable toxicity or completion of planned treatment [3 mg/kg every 2 weeks for 96 weeks or 350 mg every 3 weeks for 54 weeks].
Maltese: Fl-istudju 1540, il-pazjenti rċivew cemiplimab sakemm kien hemm progress tal-marda, tossiċità mhux aċċettabbli jew tlestija tat-trattament ippjanat [3 mg/kg kull ġimagħtejn għal 96 ġimgħa jew 350 mg kull
English: PD-L2.
Maltese: PD-1/PD-L1 oħra
English: Renal impairment
Maltese: Reazzjoni marbuta mal-infużjoni
English: Among the 11 patients with hyperthyroidism, the median time to onset was 1.9 months (range: 28 days to 14.8 months).
Maltese: Fost il-11-il pazjent b'ipertirojdiżmu, il-medjan ta' żmien għall-bidu tiegħu kien 1.9 xhur (firxa: 28 jum sa 14.8 xhur).
English: Other fatal and life-threatening immune-related adverse reactions have been observed in patients receiving cemiplimab including paraneoplastic encephalomyelitis and meningitis (see section 4.8 for other immune-related adverse reactions).
Maltese: Reazzjonijiet avversi oħra severi u ta' periku għall-ħajja marbuta mal-immunità ġew osservati f'pazjenti li kienu qed jirċievu cemiplimab inklużi enċefalomijelite paraneoplastika u meninġite (ara sezzjoni 4.8 għal reazzjonijiet avversi oħra marbuta mal-immunità).
English: The events were Grade 3 or less unless stated otherwise:
Maltese: L-avvenimenti kienu ta' Grad 3 jew anqas ħlief jekk speċifikat mod ieħor:
English: At the dosing regimens of 1 mg/kg to 10 mg/kg every two weeks, kinetics of cemiplimab were observed to be linear and dose proportional, suggesting saturation of the target-mediated pathway.
Maltese: Bl-iskedi ta' għoti tad-dożi minn 1 mg/kg sa 10 mg/kg kull ġimagħtejn, il-kinetika ta' cemiplimab ġiet osservatali hija lineari u fi proporzjon mad-doża, li tissuġġerixxi saturazzjoni tas-sensiela ta' reazzjonijiet medjata mis-sit fil-mira.
English: Cemiplimab is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.
Maltese: Cemiplimab huwa magħmul permezz ta' teknoloġija ta' DNA rikombinanti f'koltura ta' suspensjoni ta' ċelluli tal-ovarju tal-hamster Ċiniż (CHO).
English: One of the 3 patients was treated with systemic corticosteroids.
Maltese: Wieħed mit-3 pazjenti ġie ttrattat b'kortikosterojdi sistemiċi.
English: Among the 7 patients with immune-related diarrhoea or colitis, the median time to onset was 3.8 months (range: 15 days to 6.0 months) and the median duration of immune-related diarrhoea or colitis was 30 days (range: 4 days to 8.6 months).
Maltese: Fost is-7 pazjenti b'dijarea jew kolite marbuta mal-immunità, iż-żmien medjan għall-bidu tagħhom kien 3.8 xhur (firxa: 15-il jum sa 6.0 xhur) u l-medjan ta' tul ta' żmien ta' dijarea jew kolite marbuta mal-immunità kien 30 jum (firxa: 4 ijiem sa 8.6 xhur).
English: The increase of spontaneous abortion and/or resorption in animals with restricted PD-L1 expression (knock-out or anti-PD1 / PD-L1 monoclonal antibodies) has been shown in both mice and monkeys.
Maltese: Iż-żieda ta' abort spontanju u/jew assorbiment lura f'annimali b'espressjoni ristretta ta' PD-L1 (antikorpi knock-out jew monoklonali kontra PD1 / PD-L1) intweriet kemm, fil-ġrieden kif ukoll fix-xadini.
English: Detailed guidelines for the management of immune-related adverse reactions are described in Table 1.
Maltese: Linji gwida dettaljati għall-immaniġġjar ta' reazzjonjiet avversi marbuta mal-immunità huma deskritti f'Tabella 1.
English: It must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
Maltese: infużjoni ġol-vini fuq perjodu ta' 30 minuta permezz ta' pajp irqiq ġol-vini li jkollu fih filter sterili, mhux piroġeniku, b'irbit baxx mal-proteini, ġol-pajp innifsu jew imwaħħal miegħu (daqs tal-por 0.2 mikron sa 5 mikron).
English: LIBTAYO 350 mg concentrate for solution for infusion cemiplimab
Maltese: LIBTAYO 350 mg konċentrat għal soluzzjoni għall-infużjoni
English: Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Maltese: Doża inizjali ta' 1 sa 2 mg/kg/jum prednisone jew ekwivalenti segwita
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Immune-related skin adverse reactions occurred in 12 (2.0%) of 591 patients receiving cemiplimab including 6 (1.0%) patients with Grade 3 immune-related skin adverse reactions.
Maltese: Reazzjonijiet avversi fil-ġilda marbuta mal-immunità seħħew fi 12 (2.0%) minn 591 pazjent li kienu qed jirċievu cemiplimab inkluż 6 (1.0%) pazjenti b'reazzjonijiet avversi fil-ġilda marbuta mal-immunità ta' Grad 3. Reazzjonijiet avversi fil-ġilda marbuta mal-immunità wasslu għal waqfien permanenti ta' cemiplimab f'2 (0.3%) pazjenti minn 591 pazjent.
English: • Skin problems such as rash or itching, skin blistering and ulcers in mouth or other mucous membrane.
Maltese: • Problemi fil-ġilda bħal raxx jew ħakk, infafet fil-ġilda u ulċeri fil-ħalq jew f'membrani mukużi oħra.
English: Each vial contains 350 mg of cemiplimab in 7 ml.
Maltese: Kull kunjett fih 350 mg ta' cemiplimab f'7 ml.
English: Österreich sanofi-aventis GmbH Tel: +43 1 80 185 - 0
Maltese: Slovenija sanofi-aventis d.o.o. Tel: +386 1 560
English: The infusion should be stopped and cemiplimab should be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions (see section 4.2).
Maltese: L-infuzjoni għandha titwaqqaf u cemiplimab għandu jitwaqqaf għalkollox għal reazzjonijiet severi (Grad 3) jew ta'periklu għall-ħajja (Grad 4) marbuta mal-infużjoni (ara sezzjoni 4.2).
English: Initiate symptomatic management
Maltese: mmaniġġjar tas-sintomi
English: Patients should be managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Maltese: Il-pazjenti għandhom jiġu mmaniġgjati b'modifikazzjonijiet fit-trattament b'cemiplimab u bil-kortikosterojdi (ara sezzjoni 4.2).
English: Type 1 diabetes mellitus a
Maltese: Dijabete mellitus tat-tip 1
English: All prescribers of LIBTAYO should be familiar with the educational materials and inform the patients about the Patient Alert Card explaining what to do should they experience any symptom of immunerelated adverse reactions and infusion-related reactions.
Maltese: It-tabib tiegħek jista' jagħtik mediċini oħra sabiex iwaqqfu reazzjonijiet li jkunu aktar severi u jnaqqsulek is-sintomi.
English: Eighteen patients (3.0%) received high-dose corticosteroids for a median of 8.5 days (range: 1 day to 5.9 months).
Maltese: Tmintax il-pazjent (3.0%) irċivew doża għolja ta' kortikosterojdi għal medjan ta' 8.5 ijiem (firxa: jum 1 sa 5.9 xhur).
English: Muscular weakness
Maltese: Pulmonite marbuta mal-immunità
English: Efficacy results - Study 1540 - metastatic CSCC by dosing group, locally advanced CSCC
Maltese: Tabella 3: Riżultati ta' effikaċja- Stuju 1540 - CSCC metastatika skont il-grupp tad-doża, CSCC avvanzat b'mod lokali mCSCC cemiplimab: 3 mg/kg Q2W (Grupp 1) (N = 59)
English: ATC code: not yet assigned
Maltese: Kodiċi ATC: mhux assenjat
English: Type 1 diabetes mellitus led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Maltese: Dijabete mellitus tat-tip 1 wasslet għal waqfien permanenti ta' cemiplimab f'pazjent 1(0.2%) minn 591 pazjent.
English: The following clinically significant, immune-related adverse reactions occurred at an incidence of less than 1% of 591 patients treated with cemiplimab.
Maltese: Ir-reazzjonijiet avversi marbuta mal-immunità, li kienu sinifikanti b'mod kliniku li ġejjin seħħew b'inċidenza ta' anqas minn 1% tal-591 pazjent ittrattati b'cemiplimab.
English: Nephritis
Maltese: Treddigħ