FrancophonIA/ELRC3.0 huggingface dataset:
English: Rash pruritic*, erythema*, rash generalised*, psoriasis*, rash erythematous*, rash macular*, rash papular*, dermatitis exfoliative*, erythema multiforme*, pemphigoid*, pruritus generalised*, eczema, dermatitis
Maltese: Raxx bil-ħakk*, eritema*, raxx ġeneralizzat*, psorjasi*, raxx eritematuż*, raxx makulari*, raxx papulari*, dermatite bil-qxur*, eritema multiforme*,
English: Suspected myocarditis
Maltese: Mijokardite suspettata
English: Tumour samples were evaluated for PD-L1 tumour cell expression, and for Merkel cell polyomavirus (MCV) using an investigational immunohistochemistry (IHC) assay.
Maltese: Kampjuni tat-tumur ġew evalwati għall-espressjoni ta' PD-L1 fuq ċelluli tat-tumur, u għal poliomavirus taċ-ċelluli Merkel (MCV - Merkel cell polyomavirus) bl-użu ta' analiżi immunoistokimika (IHC - immunohistochemistry) investigattiva.
English: Objective response rate (ORR)
Maltese: Rata ta' rispons oġġettiv (ORR)
English: A population pharmacokinetic analysis suggested no difference in the total systemic clearance of avelumab based on age, gender, race, PD-L1 status, tumour burden, renal impairment and mild or moderate hepatic impairment.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni ma ssuġġeriet l-ebda differenza fit-tneħħija sistemika totali ta' avelumab ibbażata fuq l-età, sess, razza, stat ta' PD-L1, piż tat-tumur, indeboliment tal-kliewi u indeboliment ħafif jew moderat tal-fwied.
English: In patients treated with avelumab as monotherapy, 6% (98/1,738) of patients developed immune-related thyroid disorders, including 90 (5%) patients with hypothyroidism, 7 (0.4%) with hyperthyroidism, and 4 (0.2%) with thyroiditis.
Maltese: F'pazjenti ttrattati b'avelumab bħala monoterapija, 6% (98/1,738) tal-pazjenti żviluppaw disturbi tat tirojde relatati mal-immunità, inklużi 90 (5%) pazjent kellhom ipotirojdiżmu, 7 (0.4%) kellhom ipertirojdiżmu, u 4 (0.2%) pazjenti kellhom infjammazzjoni tal-glandola tat-tirojde.
English: Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 vs. 1) and region (United States vs. Canada/Western Europe vs. the rest of the world).
Maltese: Grupp tal-Onkoloġija tal-Kooperattiva tal-Lvant (ECOG - Eastern Cooperative Oncology Group) u r reġjun (l-Istati Uniti vs. il-Kanada/l-Ewropa tal-Punent kontra l-bqija tad-dinja).
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
Maltese: Il frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni
English: Complete response (CR)** n (%) Partial response (PR)** n (%)
Maltese: Rispons komplut (CR - complete response)** n (%) Rispons parzjali (PR - partial response)** n (%)
English: Myositis*
Maltese: Mijosite*
English: Other medicines and Bavencio
Maltese: Mediċini oħra u Bavencio
English: A risk to the breast-fed child cannot be excluded.
Maltese: Riskju għat-tarbija li qed tiġi mredda' ma jistax jiġi eskluż.
English: Of the 88 patients, 65 (74%) were male, the median age was 73 years (range 33 years to 88 years), 81 (92%) patients were Caucasian, and 49 (56%) patients and 39 (44%) patients with an Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1, respectively.
Maltese: Mit-88 pazjent, 65 (74%) kienu rġiel, l-età medjana kienet ta' 73 sena (medda 33 sena sa 88 sena), 81 (92%) pazjent kienu KawkasI, u 49 (56%) pazjent u 39 (44%) pazjent kellhom stat ta' eżekuzzjoni talGrupp tal-Onkoloġija tal-Kooperattiva tal-Lvant (ECOG - Eastern Cooperative Oncology Group) ta' 0 u 1, rispettivament.
English: Eight (88.9%) patients with immune-related adrenal insufficiency were treated with corticosteroids and 2 (25%) of the 8 patients received high-dose corticosteroids (≥ 40 mg prednisone or equivalent) for a median of 8 days (range: 5 days to 11 days).
Maltese: Tmien pazjenti (88.9%) b'insuffiċjenza adrenali relatata mal-immunità kienu ttrattati b'kortikosterojdi u 2 (25%) mit-8 pazjenti irċevew kortikosterojdi ta' doża għolja (≥ 40 mg prednisone jew ekwivalenti) għal medjan ta' 8 ijiem (medda: 5 ijiem sa 11-il ġurnata).
English: • Brief introduction to Bavencio treatment
Maltese: • Introduzzjoni qasira għal trattament b'Bavencio
English: Hepatic impairment was defined by National Cancer Institute (NCI) criteria of hepatic dysfunction.
Maltese: Indeboliment tal-fwied kien definit permezz ta' kriterji tal-Istitut Nazzjonali tal-Kanċer (NCINational Cancer Institute) ta' disfunzjoni tal-fwied.
English: It may cause side effects (see section 4).
Maltese: Jista' jikkawża effetti sekondarji (ara sezzjoni 4).
English: Adrenal insufficiency*, hyperthyroidism*, thyroiditis*, autoimmune thyroiditis*, adrenocortical insufficiency acute*, autoimmune hypothyroidism*, hypopituitarism*
Maltese: infjammazzjoni awtoimmuni tal-glandola tat-tirojde*, insuffiċjenza adrenokortikali akuta*, ipotirojdiżmu awtoimmuni*, ipopitwitariżmu*
English: Avelumab is primarily metabolised through catabolic pathways, therefore, it is not expected that avelumab will have pharmacokinetic drug-drug interactions with other medicinal products.
Maltese: Avelumab huwa metabolizzat primarjament permezz ta' rotot kataboliċi, għalhekk, mhux mistenni li avelumab ikollu interazzjoni farmakokinetika bejn mediċina u oħra ma' prodotti mediċinali oħrajn.
English: The efficacy and safety of avelumab was investigated in the study EMR100070-003 with two parts.
Maltese: L-effikaċja u s-sigurtà ta' avelumab ġew investigati fl-istudju EMR100070-003 b'żewġ partijiet.
English: Immune-related pancreatitis
Maltese: Pankreatite relatata mal-immunità
English: Avelumab pharmacokinetics (PK) was assessed using a population PK approach for avelumab as monotherapy and avelumab in combination with axitinib.
Maltese: Il-farmakokinetika (PK - pharmacokinetics) ta' avelumab ġiet evalwata bl-użu ta' approċċ PK tal popolazzjoni għal avelumab bħala monoterapija u avelumab flimkien ma' axitinib.
English: Avelumab is expected to be distributed in the systemic circulation and to a lesser extent in the extracellular space.
Maltese: Avelumab huwa mistenni li jiġi distribwit fiċ-ċirkolazzjoni sistemika u b'mod inqas fl-ispazju ekstraċellulari.
English: Avelumab should be permanently discontinued if immune-related pancreatitis is confirmed (see section 4.2).
Maltese: Avelumab għandu jitwaqqaf b'mod permanenti jekk tkun ikkonfermata pankreatite relatata mal-immunità (ara sezzjoni 4.2).
English: The median time to onset of immune-related nephritis was 1.2 months (range: 2.9 weeks to 1.8 months).
Maltese: Iż-żmien medjan għall-bidu ta' nefrite relatata mal-immunità kien ta' 1.2 xhur (medda: 2.9 ġimgħat sa 1.8 xhur).
English: Part B included patients with histologically confirmed metastatic MCC who were treatment-naïve to systemic therapy in the metastatic setting.
Maltese: Il-Parti B kienet tinkludi pazjenti b'MCC metastatika kkonfermata istoloġikament li ma kinux ittrattati qabel b'terapija sistemika f'ambjent metastatiku.
English: This is uncommon.
Maltese: Dan huwa komuni ħafna.
English: Immune-related colitis
Maltese: Kolite relatata mal-immunità
English: Avelumab should be permanently discontinued if immune-related myocarditis is confirmed (see section 4.2).
Maltese: Avelumab għandu jitwaqqaf b'mod permanenti jekk tkun ikkonfermata mijokardite relatata mal-immunità (ara sezzjoni 4.2).
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies.
Maltese: Ilpazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi kliniċi ta' endokrinopatiji.
English: Gamma-glutamyltransferase increased, blood alkaline phosphatase increased, amylase increased, lipase increased, blood creatinine increased
Maltese: Żieda ta' gamma-glutamyltransferase, żieda ta' alkaline phosphatase fid-demm, żieda ta' amylase, żieda ta' lipase, żieda ta' krejatinina fid-demm
English: Negative (n=31)
Maltese: Negattivi (n=31) IHC:
English: All 31 patients with immune-related hepatitis were treated for hepatitis including 30 (96.8%) patients treated with corticosteroids and 1 patient with a non-steroidal immunosuppressant.
Maltese: Il-31 pazjent kollha b'epatite relatata mal-immunità kienu ttrattati għall-epatite inklużi 30 pazjent (96.8%) ittrattati b'kortikosterojdi u pazjent wieħed b'immunosoppressanti mhux sterojdi.
English: Among the 73 patients who were rechallenged with either avelumab (59%) or axitinib (85%) monotherapy or with both (55%), 66% had no recurrence of ALT ≥ 3 times ULN.
Maltese: Fost it-73 pazjent li kienu ttrattati mill-ġdid b'avelumab (59%) jew axitinib (85%) bħala monoterapija jew bit-tnejn flimkien (55%), 66% ma kellhomx okkorrenza mill-ġdid ta' ALT ta' ≥ 3 darbiet l-ULN.
English: The other ingredients are mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”).
Maltese: Is-sustanzi l-oħra huma mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, ilma għallinjezzjonijiet (ara sezzjoni 2 “Bavencio għandu kontenut baxx ta' sodium”).
English: The median time to onset of immune-related pneumonitis was 3.7 months (range: 2.7 months to 8.6 months).
Maltese: Iż-żmien medjan għall-bidu ta' pulmonite relatata mal-immunità kien ta' 3.7 xhur (medda: 2.7 xhur sa 8.6 xhur).
English: The safety and efficacy of Bavencio in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Bavencio fi tfal u adolexxenti ta' età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Systemic inflammatory response syndrome*
Maltese: Sindrome ta' rispons infjammatorju sistemiku*
English: In this patient population, the most common adverse reactions were diarrhoea (62.8%), hypertension (49.3%), fatigue (42.9%), nausea (33.5%), dysphonia (32.7%), decreased appetite (26.0%), hypothyroidism (25.2%), cough (23.7%), headache (21.3%), dyspnoea (20.9%), and arthralgia
Maltese: pressjoni għolja (49.3%), għeja (42.9%), dardir (33.5%), disfonja (32.7%), tnaqqis fl-aptit (26.0%), ipotirojdiżmu ( 25.
English: Permanently discontinue
Maltese: Waqqaf b'mod permanenti
English: Of 1,738 patients treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks, 1,627 were evaluable for treatment-emergent anti-drug antibodies (ADA) and 96 (5.9%) tested positive.
Maltese: 1,627 setgħu jiġu evalwati għal antikorpi kontra l-mediċina (ADA - anti-drug antibodies) li ħarġu mittrattament, u 96 (5.9%) kellhom riżultat pożittiv.
English: Positive (n=19) Negative (n=55)
Maltese: Negattivi (n=55)
English: • you have ever had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C
Maltese: hepatitis B) jew epatite Ċ (HCV - hepatitis C);
English: Hazard ratio (95% CI) p-value*
Maltese: Medjan f'xhur (CI ta' 95%) Proporzjon ta' periklu (CI ta' 95%) valur p*
English: Complete response (CR) n (%) Partial response (PR) n (%)
Maltese: Rispons komplut (CR) n (%) Rispons parzjali (PR) n (%)
English: Pharmacotherapeutic group: Other antineoplastic agents, monoclonal antibodies, ATC code: L01XC31.
Maltese: Sustanzi antineoplastiċi oħra, antikorpi monoklonali, Kodiċi ATC:
English: • Information that avelumab can cause serious side effects during or after treatment, that need to be treated right away and warning message on the importance of being aware of signs and symptoms while receiving avelumab treatment
Maltese: • Informazzjoni li avelumab jista' jikkawża effetti sekondarji serji waqt jew wara t-trattament, li jeħtieġ li jiġu ttrattati minnufih u messaġġ ta' twissija dwar l-importanza li wieħed ikun konxju tas-sinjali u s-sintomi waqt li jkun qed jirċievi trattament b'avelumab
English: Fatigue, pyrexia, oedema peripheral
Maltese: Uġigħ ta' ras, sturdament, newropatija periferali
English: Consistent with a limited extravascular distribution, the volume of distribution of avelumab at steady state is small.
Maltese: Konsistenti ma' distribuzzjoni ekstravaskulari limitata, il-volum tad-distribuzzjoni ta' avelumab fi stat fiss huwa żgħir.
English: • Life threatening or Grade 4 adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy)
Maltese: • Reazzjoni avversa ta' periklu għall ħajja jew ta' Grad 4 (minbarra endokrinopatiji kkontrollati b'terapija ta' sostituzzjoni talormoni)
English: Table 6 summarises the subsequent interim analysis of efficacy endpoints including an estimate of the 6-month rates by Kaplan-Meier for DOR and PFS, in patients receiving avelumab at the recommended dose for study EMR100070-003, Part B.
Maltese: Tabella 6 tiġbor fil-qosor l-analiżi interim sussegwenti tal-punti finali tal-effikaċja, inkluża stima tarrati ta' 6 xhur skont Kaplan-Meier għal DOR u PFS, f'pazjenti li kienu qed jirċievu avelumab bid doża rakkomandata għall-istudju EMR100070-003, Parti B.
English: Of the 39 patients, 30 (77%) were male, the median age was 75 years (range: 47 to 88 years), 33 (85%) were Caucasian, and 31 (79%) and 8 (21%) had an ECOG performance status of 0 and 1 respectively.
Maltese: Mid-39 pazjent, 30 (77%) kienu rġiel, l-età medjana kienet ta' 75 sena (medda: 47 sa 88 sena), 33 (85%) kienu Kawkasi, u 31 (79%) u 8 (21%) kellhom stat ta' prestazzjoni ta' ECOG ta' 0 u 1
English: This removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell responses.
Maltese: CD8+ T, li jwassal għar-restawr tar-rispons taċ-ċelluli T kontra t-tumuri.
English: Minimum, maximum (months) ≥ 3 months by K-M, (95% CI) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI)
Maltese: Minimu, massimu (xhur) ≥ 3 xhur skont K-M, (CI ta' 95%) ≥ 6 xhur skont K-M, (CI ta' 95%) ≥ 12-il xahar skont K-M, (CI ta' 95%)
English: The primary efficacy endpoints were progression-free survival (PFS), as assessed by BICR using RECIST v1.1 and overall survival (OS) in the first-line treatment of patients with advanced RCC who have PD-L1-positive tumours (PD-L1 expression level ≥ 1%).
Maltese: Il-punti finali primarji tal-effikaċja kienu sopravivenza mingħajr progressjoni (PFS - progression-free survival), kif evalwat minn BICR bl-użu ta' RECIST v1.1 u s-sopravivenza globali (OS - overall survival) fi trattament tal-ewwel għażla ta' pazjenti b'RCC avvanzata li għandhom tumuri pożittivi għal PD-L1 (livell ta' espressjoni ta' PD-L1 ta' ≥ 1%).
English: Overall, 52 (59%) patients were reported to have had 1 prior anti-cancer therapy for MCC, 26 (30%) with 2 prior therapies, and 10 (11%) with 3 or more prior therapies.
Maltese: B'mod globali, 52 (59%) tal-pazjenti kienu rrappurtati li kellhom terapija waħda kontra l-kanċer minn qabel għal MCC, 26 (30%) b'2 terapiji minn qabel, u 10 (11%) bi 3 terapiji minn qabel jew aktar.
English: The exposure of avelumab increased dose-proportionally in the dose range of 10 mg/kg to 20 mg/kg every 2 weeks.
Maltese: L-esponiment għal avelumab żdied b'mod proporzjonali mad-doża fil-medda ta' dożi minn 10 mg/kg sa 20 mg/kg kull ġimagħtejn.
English: In patients treated with avelumab in combination with axitinib, 1.8% (9/489) of patients developed immune-related adrenal insufficiency.
Maltese: F'pazjenti ttrattati b'avelumab flimkien ma' axitinib, 1.8% (9/489) tal-pazjenti żviluppaw insuffiċjenza adrenali relatata mal-immunità.
English: Rash*, pruritus*, rash maculo-papular*, dry skin
Maltese: Raxx*, ħakk*, raxx makulo-papulari*, ġilda xotta
English: Italy
Maltese: Stati Uniti
English: In patients treated with avelumab in combination with axitinib, 2.7% (13/489) of patients developed immune-related colitis.
Maltese: F'pazjenti ttrattati b'avelumab flimkien ma' axitinib, 2.7% (13/489) tal-pazjenti żviluppaw kolite relatata mal-immunità.
English: In patients treated with avelumab in combination with axitinib, immune-related nephritis occurred in 0.4% (2/489) of patients.
Maltese: F'pazjenti ttrattati b'avelumab flimkien ma' axitinib, nefrite relatata mal-immunità seħħet f'0.4% (2/489) tal-pazjenti.
English: Table 5: Objective response rates by PD-L1 expression and MCV tumour status in patients with metastatic MCC in study EMR100070-003 (Part A)
Maltese: Tabella 5 tagħti l-espressjoni ta' PD-L1 fil-qosor u l-istat ta' MCV ta' pazjenti b'MCC metastatika fl-istudju EMR100070-003 (Parti A).
English: Each mL of concentrate contains 20 mg of avelumab.
Maltese: Kull mL ta' konċentrat fih 20 mg ta' avelumab.
English: Corticosteroids should be administered (1 to 2 mg/kg/day prednisone intravenously or oral equivalent) for Grade ≥ 3 adrenal insufficiency followed by a taper until a dose of less than or equal to 10 mg/day has been reached.
Maltese: Kortikosterojdi għandhom jingħataw (1 sa 2 mg/kg/jum ta' prednisone ġol-vini jew l-ekwivalenti mill-ħalq) għal insuffiċjenza adrenali ta' Grad ≥ 3 segwit minn tnaqqis bil-mod sakemm tintlaħaq doża ta' inqas minn jew ugwali għal 10 mg/jum.
English: Serum creatinine more than 6 times ULN Permanently discontinue
Maltese: Kreatinina fis-serum ta' aktar minn 6 darbiet tal-ULN
English: In 1-month and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the female reproductive organs.
Maltese: Fl-istudji ta' xahar u 3 xhur fix-xadini dwar l-effett tossiku minn dożi ripetuti, ma kienx hemm effetti notevoli fl-organi riproduttivi femminili.
English: Bavencio has to be diluted with either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection.
Maltese: Bavencio għandu jiġi dilwit ma' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride jew ma' soluzzjoni għall-injezzjoni ta' 4.5 mg/mL (0.45%) sodium chloride.
English: Your doctor may
Maltese: Probabilità ta' PFS
English: The median time to onset of immune-related hepatitis was 2.3 months (range: 2.1 weeks to 14.5 months).
Maltese: Iż-żmien medjan għall-bidu ta' epatite relatata mal-immunità kien ta' 2.3 xhur (medda: 2.1 ġimgħat sa 14.5 xhur).
English: Minimum, maximum (months) ≥ 6 months by K-M, (95% CI) ≥ 12 months by K-M, (95% CI) ≥ 24 months by K-M, (95% CI) ≥ 36 months by K-M, (95% CI)
Maltese: Minimu, massimu (xhur) ≥ 6 xhur skont K-M, (CI ta' 95%) ≥ 12-il xahar skont K-M, (CI ta' 95%) ≥ 24 xahar skont K-M, (CI ta' 95%) ≥ 36 xahar skont K-M, (CI ta' 95%)
English: Grade 3 or Grade 4 pneumonitis or recurrent Grade 2 pneumonitis
Maltese: Pulmonite ta' Grad 3 jew Grad 4 jew pulmonite rikorrenti ta' Grad 2
English: • Merkel cell carcinoma (MCC), a rare type of skin cancer, when it is metastatic (has spread to other parts of the body).
Maltese: • Karċinoma taċ-ċelluli Merkel (MCC - Merkel cell carcinoma), tip rari ta' kanċer tal-ġilda,
English: Blood creatinine increased, amylase increased, lipase increased, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinase increased, blood thyroid stimulating hormone decreased, transaminases increased
Maltese: Żieda ta' krejatinina fid-demm, żieda ta' amylase, żieda ta' lipase, żieda ta' gamma-glutamyltransferase, żieda ta' alkaline phosphatase fid-demm, żieda ta' creatine phosphokinase fid-demm, tnaqqis tal-ormon li jistimula t-tirojde fid-demm, żieda ta' transaminases
English: Drug eruption, erythema multiforme, psoriasis
Maltese: Raxx ikkawżat mill-mediċina, eritema multiforme, psorjasi
English: • Inflammatory reaction of the whole body (Systemic inflammatory response syndrome)
Maltese: • Reazzjoni infjammatorja tal-ġisem kollu (Sindrome ta' rispons infjammatorju sistemiku)
English: Figure 3: Kaplan-Meier estimates for progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Maltese: Figura 3: Stimi Kaplan-Meier għal sopravivenza mingħajr progressjoni ibbażati fuq valutazzjoni ta' BICR fil-pazjenti irrispettivament mill-espressjoni ta' PD-L1
English: Table 4: Response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part A)*
Maltese: Tabella 4: Rispons għal avelumab 10 mg/kg kull ġimagħtejn f'pazjenti b'MCC metastatika fi studju EMR100070-003 (Parti A)*
English: • Brief introduction to avelumab (indication and purpose of this tool)
Maltese: • Introduzzjoni qasira għal avelumab (indikazzjoni u l-għan ta' din l-għodda)
English: Hepatotoxicity (in combination with axitinib)
Maltese: Epatotossiċità (flimkien ma' axitinib)
English: Of the 480 patients with at least one valid ADA result at any time point treated with avelumab 10 mg/kg as an intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily, 453 were evaluable for treatment-emergent ADA and 66 (14.6%) tested positive.
Maltese: Mill-480 pazjent b'mill-inqas riżultat validu wieħed ta' ADA fi kwalunkwe punt ta' ħin ittrattati b'avelumab 10 mg/kg bħala infużjoni ġol-vini kull ġimagħtejn flimkien ma' axitinib 5 mg darbtejn kuljum, 453 setgħu jiġu evalwati għal ADA li ħarġu mat-trattament u 66 (14.6%) kellhom riżultati tat test pożittivi.
English: The median duration was 7 weeks (range: 4 days to more than 4 months).
Maltese: It-tul medjan kien ta' 7 ġimgħat (medda: 4 ijiem sa aktar minn 4 xhur).
English: • Muscle pain
Maltese: • Uġigħ fil-muskoli
English: Bavencio contains the active substance avelumab, a monoclonal antibody (a type of protein) that attaches to a specific target in the body called PD-L1.
Maltese: Bavencio fih is-sustanza attiva avelumab, antikorp monoklonali (tip ta' proteina) li teħel ma' mira speċifika fil-ġisem imsejħa PD-L1.
English: • An infusion bag of appropriate size (preferably 250 mL) containing either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection should be used.
Maltese: • Għandha tintuża borża tal-infużjoni ta' daqs xieraq (preferibbilment ta' 250 mL) li jkun fiha soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride jew soluzzjoni għall-injezzjoni ta' 4.5 mg/mL (0.45%) sodium chloride.
English: Withhold until adverse reactions recover to
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: Human IgG1 immunoglobulins are known to cross the placental barrier.
Maltese: IgG1 umani huma magħrufa li jgħaddu mill-barriera tal-plaċenta.
English: In patients treated with avelumab in combination with axitinib, 6.3% (31/489) of patients developed immune-related hepatitis.
Maltese: F'pazjenti ttrattati b'avelumab flimkien ma' axitinib, 6.3% (31/489) tal-pazjenti żviluppaw epatite relatata mal-immunità.
English: Immune-related hepatitis resolved in 27 (87.1%) of the 31 patients at the time of data cut-off.
Maltese: Epatite relatata mal-immunità fieqet f'27 (87.1%) mill-31 pazjent fiż-żmien meta waqfet tinġabar id-data.
English: Serious adverse reactions were immune-related adverse reactions and infusion-related reaction (see section 4.4).
Maltese: Reazzjonijiet avversi serji kienu reazzjonijiet avversi relatati mal-immunità u reazzjoni relatata mal-infużjoni (ara sezzjoni 4.4).
English: Table 4 summarises efficacy endpoints in patients receiving avelumab at the recommended dose for study EMR100070-003, Part A, with a minimum follow-up of 36 months.
Maltese: Tabella 4 tagħti sommarju tal-punti finali tal-effikaċja f'pazjenti li kienu qed jirċievu avelumab fid doża rakkomandata għall-istudju EMR100070-003, Parti A, b'segwitu minimu ta' 36 xahar.
English: Of these patients, there were 18 (3.7%) patients with Grade 3 and 3 (0.6%) patients with Grade 4 immune-related hepatitis.
Maltese: Minn dawn il-pazjenti, kien hemm 18-il pazjent (3.7%) b'epatite relatata malimmunità ta' Grad 3 u 3 pazjenti (0.6%) b'epatite relatata mal-immunità ta' Grad 4.
English: In patients treated with avelumab as monotherapy, 0.5% (8/1,738) of patients developed immune-related adrenal insufficiency.
Maltese: Insuffiċjenza adrenali F'pazjenti ttrattati b'avelumab bħala monoterapija, 0.5% (8/1,738) tal-pazjenti żviluppaw insuffiċjenza adrenali relatata mal-immunità.
English: Elderly No dose adjustment is needed for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża għall-pazjenti anzjani (≥ 65 sena) (ara sezzjonijiet 5.1 u 5.2).