FrancophonIA/ELRC3.0 huggingface dataset:
English: • Description of the main signs and symptoms of the following safety concerns and reminder of the importance of notifying their treating physician immediately if symptoms occur, persist or worsen: o Immune-Related Pneumonitis o Immune-Related Hepatitis o Immune-Related Colitis o Immune-Related Pancreatitis o Immune-Related Myocarditis o Immune-Related Endocrinopathies (diabetes mellitus, thyroid disorders, adrenal insufficiency) o Immune-related nephritis and renal dysfunction o Other immune-related adverse reactions including myositis, hypopituitarism, uveitis and Guillain-Barre Syndrome o Infusion-Related Reactions
Maltese: o Pulmonite Relatata mal-Immunità o Epatite Relatata mal-Immunità o Kolite Relatata mal-Immunità o Pankreatite Relatata mal-Immunità o Mijokardite Relatata mal-Immunità o Endokrinopatiji Relatati mal-Immunità (dijabete mellitus, disturbi fit-tirojde,
English: Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at 20°C to 25°C and room light.
Maltese: Stabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni dilwita ntweriet għal 24 siegħa f'temperatura ta'
English: • give you other medicines in order to prevent complications and reduce your symptoms,
Maltese: • jagħtik mediċini oħra sabiex jipprevjeni kumplikazzjonijiet u jnaqqas is-sintomi tiegħek,
English: IV after dilution
Maltese: IV wara d-dilwizzjoni
English: For instructions on the preparation and administration of the medicinal product, see section 6.6.
Maltese: Għal istruzzjonijiet fuq il-preparazzjoni u l-għoti tal-prodott mediċinali, ara sezzjoni 6.6.
English: A new ADA method with improved sensitivity and drug tolerance was used in the RCC population.
Maltese: Metodu ġdid ta' ADA b'sensittività mtejba u tolleranza għall-mediċina ntuża filpopolazzjoni b'RCC.
English: Corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper) should be administered for Grade ≥ 2 nephritis.
Maltese: Kortikosterojdi (doża inizjali ta' 1 sa 2 mg/kg/jum ta' prednisone jew ekwivalenti, segwit minn tnaqqis bil-mod tal-kortikosterojdi) għandhom jingħataw għal nefrite ta' Grad ≥ 2.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: In patients treated with avelumab as monotherapy, 1.5% (26/1,738) of patients developed immune-related colitis.
Maltese: F'pazjenti ttrattati b'avelumab bħala monoterapija, 1.5% (26/1,738) tal-pazjenti żviluppaw kolite relatata mal-immunità.
English: Avelumab was discontinued in 4.7% (23/489) of patients due to immune-related hepatitis.
Maltese: Avelumab twaqqaf f'4.7% (23/489) tal-pazjenti minħabba epatite relatata mal-immunità.
English: Store in a refrigerator (2°C - 8°C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2°C - 8°C).
English: Treatment-related adverse reaction
Maltese: TAL-PRODOTT MEDIĊINALI
English: In patients treated with avelumab in combination with axitinib, 0.6% (3/489) of patients developed immune-related pneumonitis.
Maltese: F'pazjenti ttrattati b'avelumab flimkien ma' axitinib, 0.6% (3/489) tal-pazjenti żviluppaw pulmonite relatata mal-immunità.
English: Immune-related myocarditis has been reported in patients receiving avelumab.
Maltese: Mijokardite relatata mal-immunità kienet irrappurtata f'pazjenti li kienu qed jirċievu avelumab.
English: No clinically important differences in the clearance of avelumab were found between patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN or bilirubin between 1 and 1.5 times ULN, n=217) and normal hepatic function (bilirubin and AST ≤ ULN, n=1,388) in a population PK analysis.
Maltese: F'analiżi tal-PK tal-popolazzjoni, ma nstabet l-ebda differenza klinikament importanti fit-tneħħija ta' avelumab bejn pazjenti b'indeboliment tal-fwied ħafif (bilirubina ≤ ULN u AST > ULN jew bilirubina bejn 1 u 1.5 darbiet l-ULN, n=217) u funzjoni tal-fwied normali (bilirubina u AST ≤ ULN, n=1,388).
English: Figure 4: Forest plot of progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Maltese: Figura 4: Forest plot ta' sopravivenza mingħajr progressjoni abbażi ta' valutazzjoni ta' BICR fil-pazjenti irrispettivament mill-espressjoni ta' PD-L1
English: Immune-related colitis resolved in 10 (76.9%) of 13 patients at the time of data cut-off.
Maltese: Kolite relatata mal-immunità fieqet f'10 (76.9%) mit-13-il pazjent fiż-żmien meta waqfet tinġabar id data.
English: In patients treated with avelumab as monotherapy, 1.2% (21/1,738) of patients developed immune-related pneumonitis.
Maltese: F'pazjenti ttrattati b'avelumab bħala monoterapija, 1.2% (21/1,738) tal-pazjenti żviluppaw pulmonite relatata mal-immunità.
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related adrenal insufficiency.
Maltese: Minn dawn il-pazjenti, kien hemm 2 pazjenti (0.4%) b'insuffiċjenza adrenali relatata mal-immunità ta' Grad 3.
English: Avelumab should be withheld for Grade 2 immune-related pneumonitis until resolution, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 immune-related pneumonitis (see section 4.2).
Maltese: Għal pulmonite relatata mal-immunità ta' Grad 2 Avelumab għandu jitwaqqaf sakemm tgħaddi, u għal pulmonite ta' Grad 3, Grad 4 jew pulmonite relatata mal-immunità ta' Grad 2 rikorrenti, għandu jitwaqqaf b'mod permanenti (ara sezzjoni 4.2).
English: Avelumab was discontinued in 0.2% (1/489) of patients due to Type 1 diabetes mellitus.
Maltese: Avelumab twaqqaf f'0.2% (1/489) tal-pazjenti minħabba dijabete mellitus tat-Tip 1.
English: • Sunitinib 50 mg once daily orally for 4 weeks followed by 2 weeks off (N=444) until radiographic or clinical progression or unacceptable toxicity.
Maltese: • Sunitinib 50 mg darba kuljum mill-ħalq għal 4 ġimgħat segwit minn ġimagħtejn mingħajr terapija (N=444) sa progressjoni radjugrafika jew klinika jew tossiċità mhux aċċettabbli.
English: If no improvement within 24 hours on corticosteroids, additional immunosuppression (e.g., mycophenolate, infliximab, anti-thymocyte globulin) should be considered.
Maltese: Jekk ma jkunx hemm titjib fi żmien 24 siegħa fuq il kortikosterojdi, għandha tiġi kkunsidrata immunosoppressjoni addizzjonali (eż., mycophenolate, infliximab, anti-thymocyte globulin).
English: In patients treated with avelumab as monotherapy, immune-related myocarditis occurred in less than 1% (5/4,000) of patients across clinical trials in multiple tumour types and in 0.6% (3/489) of patients receiving avelumab in combination with axitinib including 2 (0.4%) patients with fatal outcome.
Maltese: F'pazjenti ttrattati b'avelumab bħala monoterapija, mijokardite relatata mal-immunità seħħet f'inqas minn 1% (5/4,000) tal-pazjenti matul provi kliniċi b'tipi multipli ta' tumuri u f'0.6% (3/489) tal pazjenti li kienu qed jirċievu avelumab flimkien ma' axitinib inklużi 2 pazjenti (0.4%) b'riżultat fatali.
English: Grade 3 or Grade 4 infusion-related reaction
Maltese: Reazzjoni relatata mal-infużjoni ta' Grad 3 jew Grad 4
English: Time to response (TTR)
Maltese: Żmien għar-rispons (TTR)
English: Avelumab was discontinued in 0.4% (2/489) of patients due to immune-related colitis.
Maltese: Avelumab twaqqaf f'0.4% (2/489) tal-pazjenti minħabba kolite relatata mal-immunità.
English: The median duration of response was not estimable (95% CI: 4 months, not estimable) with a minimum of 1.2 months to a maximum of 8.3 months duration.
Maltese: It-tul medjan tar-rispons ma setax jiġi stmat (CI ta' 95%: 4 xhur, ma setax jiġi stmat) b'minimu ta' 1.2 xhur sa massimu ta' 8.3 xhur.
English: The key secondary endpoints were PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PD-L1 expression.
Maltese: Il-punti finali sekondarji ewlenin kienu PFS ibbażata fuq valutazzjoni ta' BICR skont RECIST v1.1 u OS irrispettivament mill-espressjoni ta' PD-L1.
English: The recommended dose of Bavencio as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks.
Maltese: Id-doża rakkomandata ta' Bavencio bħala monoterapija hija ta' 800 mg mogħtija ġol-vini fuq perjodu ta' 60 minuta kull ġimagħtejn.
English: Immune-related thyroid disorders, immune-related adrenal insufficiency, and Type 1 diabetes mellitus have been reported in patients receiving avelumab (see section 4.8).
Maltese: Disturbi tat-tirojde relatati mal-immunità, insuffiċjenza adrenali relatata mal-immunità, u dijabete mellitus ta' Tip 1 ġew irrappurtati f'pazjenti li kienu qed jirċievu avelumab (ara sezzjoni 4.8).
English: Based on a population pharmacokinetic analysis from 1,629 patients, the value of total systemic clearance (CL) is 0.59 L/day.
Maltese: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni minn 1,629 pazjent, il-valur tat-tneħħija (CLclearance) sistemika totali huwa ta' 0.59
English: Immune-related nephritis and renal dysfunction Avelumab can cause immune-related nephritis (see section 4.8).
Maltese: Avelumab jista' jikkawża nefrite relatata mal-immunità (ara sezzjoni 4.8).
English: In patients treated with avelumab as monotherapy, immune-related pancreatitis occurred in less than 1% (1/4,000) of patients across clinical trials in multiple tumour types and in 0.6% (3/489) of patients receiving avelumab in combination with axitinib including 2 (0.4%) patients with fatal outcome.
Maltese: F'pazjenti ttrattati b'avelumab bħala monoterapija, pankreatite relatata mal-immunità seħħet f'inqas minn 1% (1/4,000) tal-pazjenti matul provi kliniċi b'tipi multipli ta' tumuri u f'0.6% (3/489) tal pazjenti li kienu qed jirċievu avelumab flimkien ma' axitinib inklużi 2 pazjenti (0.4%) b'riżultat fatali.
English: Avelumab should be withheld for Grade 3 or Grade 4 symptomatic adrenal insufficiency (see section 4.2).
Maltese: Avelumab m'għandux jingħata f'każ ta' insuffiċjenza adrenali sintomatika ta' Grad 3 jew Grad 4 (ara sezzjoni 4.2).
English: The median time to onset of thyroid disorders was 2.8 months (range: 3.6 weeks to 19.3 months).
Maltese: Iż-żmien medjan għall-bidu ta' disturbi tat-tirojde kien ta' 2.8 xhur (medda: 3.6 ġimgħat sa 19.3 xhur).
English: The following side effects have been reported in clinical trials with avelumab in combination with axitinib:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati fi provi kliniċi b'avelumab waħdu:
English: Liver function test increased
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: In ADA positive patients, there may be an increased risk for infusion-related reactions (about 40% and 25% in ADA ever-positive and ADA never-positive patients, respectively).
Maltese: F'pazjenti pożittivi għal ADA jista' jkun hemm żieda fir-riskju ta' reazzjonijiet relatati mal-infużjoni (madwar 40% u 25% f'pazjenti dejjem pożittivi għal ADA u pazjenti li qatt ma kienu pożittivi għal ADA, rispettivament).
English: When avelumab 10 mg/kg was administered in combination with axitinib 5 mg, the respective exposures of avelumab and axitinib were unchanged compared to the single agents.
Maltese: Meta avelumab 10 mg/kg ingħata flimkien ma' axitinib 5 mg, l-esponimenti rispettivi għal avelumab u axitinib ma nbidlux meta mqabbla mas-sustanzi waħedhom.
English: In patients treated with avelumab as monotherapy, 0.9% (16/1,738) of patients developed immune-related hepatitis.
Maltese: F'pazjenti ttrattati b'avelumab bħala monoterapija, 0.9% (16/1,738) tal-pazjenti żviluppaw epatite relatata mal-immunità.
English: • Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking)
Maltese: • Sindrome ta' Guillaine-Barré (disturb tas-sistema immuni li jikkawża infjammazzjoni tan nervituri u jista' jwassal għal uġigħ, tnemnim, dgħufija fil-muskoli u diffikultà biex timxi)
English: Hypertension
Maltese: Fertilità
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR(I) TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Merkel cell carcinoma
Maltese: Karċinoma taċ-ċelluli Merkel
English: How to store Bavencio
Maltese: Kemm se tirċievi Bavencio
English: The efficacy and safety of avelumab in combination with axitinib was demonstrated in study B9991003, a randomised, multicentre, open-label study of avelumab in combination with axitinib in 886 patients with untreated advanced or metastatic RCC with a clear-cell component.
Maltese: L-effikaċja u s-sigurtà ta' avelumab flimkien ma' axitinib intwerew fl-istudju B9991003, studju randomised, b'aktar minn ċentru wieħed u open-label ta' avelumab flimkien ma' axitinib f'886 pazjent b'RCC avvanzata jew metastatika mhux ittrattata b'komponent ta' ċelluli ċari.
English: Immune-related colitis Immune-related colitis has been reported in patients receiving avelumab (see section 4.8).
Maltese: Kolite relatata mal-immunità kienet irrappurtata f'pazjenti li kienu qed jirċievu avelumab (ara sezzjoni 4.8).
English: Median, months (95% CI)
Maltese: Medjan, xhur (CI ta' 95%)
English: In patients treated with avelumab as monotherapy, Type 1 diabetes mellitus without an alternative aetiology occurred in 0.1% (2/1,738) of patients including two Grade 3 reactions that led to permanent discontinuation of avelumab.
Maltese: F'pazjenti ttrattati b'avelumab bħala monoterapija, dijabete mellitus ta' Tip 1 mingħajr etjoloġija alternattiva seħħet f'0.1% (2/1,738) tal-pazjenti, inklużi żewġ reazzjonijiet ta' Grad 3 li wasslu għal twaqqif permanenti ta' avelumab.
English: • Patient Information brochure
Maltese: • Tnaqqis fil-pressjoni
English: Oedema peripheral, influenza like illness
Maltese: Edima periferali, marda li tixbah lill-influwenza
English: Adverse reactions Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna
English: Grade 2 infusion-related reaction
Maltese: Reazzjoni relatata mal-infużjoni ta' Grad 2
English: The study population characteristics were: median age of 61 years (range: 27.0 to 88.0), 38% of patients were 65 years or older, 75% were male, 75% were White, and the ECOG performance score was 0 (63%) or 1 (37%).
Maltese: sa 88.0), 38% tal-pazjenti kellhom 65 sena jew aktar, 75% kienu rġiel, 75% kienu Bojod, u l-punteġġ ta' prestazzjoni tal-ECOG kien ta' 0 (63%) jew 1 (37%).
English: Thyroid disorders (hypothyroidism/hyperthyroidism) Thyroid disorders can occur at any time during treatment (see section 4.8).
Maltese: Disturbi tat-tirojde jistgħu jseħħu fi kwalunkwe ħin matul it-trattament (ara sezzjoni 4.8).
English: The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of avelumab, including immune-related pneumonitis, hepatitis, colitis, pancreatitis, myocarditis, thyroid disorders, adrenal insufficiency, type 1 diabetes mellitus, nephritis and renal dysfunction, myositis, hypopituitarism, uveitis, GuillainBarre syndrome and infusion related reactions, and how to manage them.
Maltese: pankreatite, mijokardite, disturbi fit-tirojde, insuffiċjenza adrenali, dijabete mellitus tat-tip 1, nefrite u disfunzjoni tal-kliewi, mijosite, ipopitwitariżmu, uveite u s-Sindrome ta' Guillain-Barre relatati mal immunità u reazzjonijiet relatati mal-infużjoni, u kif għandhom jiġu immaniġġjati.
English: Tabulated list of adverse reactions
Maltese: Frekwenza Reazzjonijiet avversi
English: Adverse reactions Infections and infestations
Maltese: Infezzjonijiet u infestazzjonijiet
English: Immune-related pneumonitis resolved in 2 (66.7%) of the 3 patients at the time of data cut-off.
Maltese: Pulmonite relatata mal-immunità fieqet fi 2 (66.7%) mit
English: Hepatotoxicity occurred in patients treated with avelumab in combination with axitinib with higher than expected frequencies of Grade 3 and Grade 4 ALT and AST elevation compared to avelumab alone (see section 4.8).
Maltese: Epatotossiċità (flimkien ma' axitinib) Epatotossiċità seħħet f'pazjenti ttrattati b'avelumab flimkien ma' axitinib bi frekwenzi ogħla milli mistennija ta' żieda fl-ALT u AST ta' Grad 3 u Grad 4 meta mqabbel ma' avelumab waħdu (ara sezzjoni 4.8).
English: Thyroid disorders resolved in 15 (12.4%) of the 121 patients at the time of data cut-off.
Maltese: Disturbi tat-tirojde fiequ fi 15 (12.4%) mill-121 pazjent fiż-żmien meta waqfet tinġabar id-data.
English: The median time to onset of immune-related pneumonitis was 2.5 months (range: 3 days to 11 months).
Maltese: Iż-żmien medjan għall-bidu ta' pulmonite relatata mal-immunità kien ta' 2.5 xhur (medda: 3 ijiem sa 11-il xahar).
English: • Persistent Grade 2 or Grade 3 immune-mediate adverse reactions lasting 12 weeks or longer
Maltese: • Reazzjonijiet avversi medjati millimmunità persistenti ta' Grad 2 jew Grad 3 li jdumu 12-il ġimgħa jew aktar
English: Of these patients, there were 2 (0.1%) patients with a fatal outcome, and 11 (0.6%) patients with Grade 3 immune-related hepatitis.
Maltese: Minn dawn il-pazjenti kien hemm 2 (0.1%) pazjenti b'riżultat fatali, u 11-il pazjent (0.6%) b'epatite relatata mal-immunità ta' Grad 3.
English: Table 7: Efficacy results from study B9991003 in patients irrespective of PD-L1 expression Efficacy endpoints (Based on BICR assessment)
Maltese: Riżultati tal-effikaċja mill-istudju B9991003 fil-pazjenti irrispettivament millespressjoni ta' PD-L1
English: Of these patients, there were 9 (1.8%) patients with Grade 3 immune-related colitis.
Maltese: Minn dawn il-pazjenti, kien hemm 9 pazjenti (1.8%) b'kolite relatata malimmunità ta' Grad 3.
English: Headache, dizziness
Maltese: Disfonja, sogħla, qtugħ ta' nifs
English: The safety of avelumab as monotherapy has been evaluated in 1,738 patients with solid tumours including metastatic MCC receiving 10 mg/kg every 2 weeks of avelumab in clinical studies.
Maltese: Sommarju tal-profil tas-sigurtà Is-sigurtà ta' avelumab bħala monoterapija ġiet evalwata f'1,738 pazjent b'tumuri solidi inkluż MCC
English: Efficacy results are presented in Table 7 and Figure 3 based on a data cut-off date of 28 January 2019.
Maltese: Ir-riżultati tal-effikaċja huma ppreżentati fit-Tabella 7 u l-Figura 3 abbażi ta' data meta waqfet tinġabar id-data ta' 28 ta' Jannar 2019.
English: Objective response rate (ORR) n (%) (95% CI)
Maltese: Irrata ta' rispons oġġettiv (ORR - objective response rate) kienet ta' 62.1% (CI ta' 95%:
English: • Decreased kidney function
Maltese: • Tnaqqis fil-funzjoni tal-kliewi
English: Perivascular mononuclear cell cuffing was observed in the brain and spinal cord of monkeys treated with avelumab at ≥ 20 mg/kg for 3 months.
Maltese: Tnaqqis ta' ċelluli mononukleari perivaskulari ġie osservat fil-moħħ u fissinsla tad-dahar ta' xadini ttrattati b'avelumab b'≥ 20 mg/kg għal 3 xhur.
English: All 8 patients with immune-related adrenal insufficiency were treated with corticosteroids, 4 (50%) of the 8 patients received high-dose systemic corticosteroids (≥ 40 mg prednisone or equivalent) followed by a taper for a median of 1 day (range: 1 day to 24 days).
Maltese: It-8 pazjenti kollha b'insuffiċjenza adrenali relatata mal-immunità kienu ttrattati b'kortikosterojdi, 4 (50%) mit-8 pazjenti rċevew doża għolja ta' kortikosterojdi sistemici (≥ 40 mg prednisone jew ekwivalenti) segwit minn tnaqqis bil-mod għal medjan ta' ġurnata (medda: ġurnata sa
English: Corticosteroids should be considered for Grade ≥ 2 events (see section 4.2).
Maltese: F'każ ta' avvenimenti ta' Grad ≥ 2 għandhom jiġu kkunsidrati l-kortikosterojdi (ara sezzjoni 4.2).
English: Hyperthyroidism, adrenal insufficiency, thyroiditis
Maltese: Ipertirojdiżmu, insuffiċjenza adrenali, infjammazzjoni tal-glandola tat tirojde
English: Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related adrenal insufficiency.
Maltese: Avelumab twaqqaf f'0.1% (2/1,738) tal-pazjenti minħabba insuffiċjenza adrenali relatata mal immunità.
English: Immune-related pneumonitis resolved in 12 (57%) of the 21 patients at the time of data cut-off.
Maltese: Pulmonite relatata mal-immunità fieqet fi 12 (57%) minn 21 pazjent fiż-żmien meta waqfet tinġabar id-dejta.
English: The median duration was 2.6 months (range: 3.3 weeks to more than 7.9 months).
Maltese: It-tul medjan kien ta' 2.6 xhur (medda: 3.3 ġimgħat sa aktar minn 7.9 xhur).
English: Administration of avelumab and axitinib was permitted beyond RECIST-defined disease progression based on investigator's assessment of the patient's benefit-risk and clinical condition, including performance status, clinical symptoms, adverse events and laboratory data.
Maltese: L-għoti ta' avelumab u axitinib kien permess wara l progressjoni tal-marda definita minn RECIST abbażi tal-valutazzjoni mill-investigatur tar-riskju u l benefiċċju u l-kundizzjoni klinika tal-pazjent, inklużi l-istat ta' eżekuzzjoni, sintomi kliniċi,
English: B. PACKAGE LEAFLET
Maltese: Bajda Asjatika
English: Three patients were reported to be overdosed with 5% to 10% above the recommended dose of avelumab.
Maltese: Tliet pazjenti kienu rrappurtati li ngħataw doża eċċessiva b'5% sa 10% ogħla mid-doża rakkomandata ta' avelumab.
English: Hepatitis, hepatotoxicity, immune-mediated hepatitis, liver disorder
Maltese: Epatite, epatotossiċità, epatite medjata mill-immunità, disturb fil-fwied
English: Median PFS, months (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) 24-month PFS rate by K-M, (95% CI) 36-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier; +denotes a censored value * Efficacy data with a minimum follow-up of 36 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Maltese: PFS medjana, xhur (CI ta' 95%) Rata ta' PFS ta' 3 xhur skont K-M, (CI ta' 95%) Rata ta' PFS ta' 6 xhur skont K-M, (CI ta' 95%) Rata ta' PFS ta' 12-il xahar skont K-M, (CI ta' 95%) CI: Intervall ta' kunfidenza; RECIST:
English: Drug hypersensitivity, hypersensitivity anaphylactic reaction, Type I hypersensitivity
Maltese: Sensittività eċċessiva għall-mediċina, reazzjoni anafilattika ta' sensittività eċċessiva, sensittività eċċessiva ta' Tip 1
English: Avelumab should be withheld for Grade 2 or Grade 3 immune-related colitis until resolution, and permanently discontinued for Grade 4 or recurrent Grade 3 immune-related colitis (see section 4.2).
Maltese: Għal kolite relatata mal-immunità ta' Grad 2 jew Grad 3 Avelumab għandu jitwaqqaf sakemm tgħaddi, u għal kolite relatata mal-immunità ta' Grad 4 jew rikorrenti ta' Grad 3 għandu jitwaqqaf b'mod permanenti (ara sezzjoni 4.2).
English: Of these patients, there were 7 (0.4%) patients with Grade 3 immune-related colitis.
Maltese: Minn dawn il-pazjenti kien hemm 7 (0.4%) pazjenti b'kolite relatata malimmunità ta' Grad 3.
English: It is administered over 60 minutes as an intravenous infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter.
Maltese: Jingħata fuq perjodu ta' 60 minuta bħala infużjoni ġol-vini permezz ta' filtru fil-pajp jew miżjud ta' 0.2 mikrometri, sterili,
English: Corticosteroids should be administered for immune-related pancreatitis (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper).
Maltese: Kortikosterojdi għandhom jingħataw għal pankreatite relatata mal-immunità (doża inizjali ta' 1 sa 2 mg/kg/jum ta' prednisone jew ekwivalenti, segwita minn tnaqqis bil-mod tal-kortikosterojdi).
English: IHC: Immunohistochemistry; MCV: Merkel cell polyomavirus; ORR: objective response rate a Based on data from patients evaluable for PD-L1 b Based on data from patients evaluable for MCV by immunohistochemistry (IHC)
Maltese: Immunoistokimika; MCV: Poliomavirus taċ-ċelluli Merkel;
English: Patients should be monitored for signs and symptoms of immune-related pancreatitis.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' pankreatite relatata mal-immunità.
English: Patients should be monitored for signs and symptoms of immune-related myocarditis.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' mijokardite relatata mal-immunità.