FrancophonIA/ELRC3.0 huggingface dataset:
English: Avelumab was discontinued in 0.3% (6/1,738) of patients due to immune-related pneumonitis.
Maltese: Avelumab twaqqaf f'0.3% (6/1,738) tal-pazjenti minħabba pulmonite relatata mal-immunità.
English: Diabetes mellitus, Type 1 diabetes mellitus
Maltese: Dijabete mellitus, dijabete mellitus tat-Tip 1
English: • problems with your kidneys;
Maltese: • problemi fil-kliewi tiegħek;
English: Thrombocytopenia, eosinophilia§
Maltese: Jekk is-soluzzjoni tkun imdardra, bidlet il-kulur,
English: Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss.
Maltese: Imblokk tas-sinjalazzjoni PD-L1 ġie muri fil-mudelli ta' ġrieden tqal li jħarbat it-tolleranza għall-fetu u li jwassal għal żieda fit-telf tal-fetu.
English: Myalgia
Maltese: Irġiel
English: Endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia)
Maltese: (ipotirojdiżmu, ipertirojdiżmu, insuffiċjenza adrenali, ipergliċemija)
English: Prior to launch of Bavencio in each Member State the marketing authorisation holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tqegħid fis-suq ta' Bavencio f'kull Stat Membru id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH - marketing authorisation holder) għandu jaqbel dwar il-kontenut u d-disinn talprogramm edukattiv, inkluż mezzi ta' komunikazzjoni, modalitajiet ta' distribuzzjoni, u kull aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Of these patients, there was 1 (0.1%) patient with a fatal outcome, 1 (0.1%) patient with Grade 4, and 5 (0.3%) patients with Grade 3 immune-related pneumonitis.
Maltese: pazjent wieħed (0.1%) b'pulmonite relatata mal-immunità ta' Grad 4, u 5 pazjenti (0.3%) b'pulmonite relatata mal-immunità ta' Grad 3.
English: Avelumab should be withheld for Grade 2 or Grade 3 nephritis until resolution to ≤ Grade 1 and permanently discontinued for Grade 4 nephritis.
Maltese: Avelumab m'għandux jingħata għal nefrite ta' Grad 2 jew Grad 3 sakemm titjieb għal ≤ Grad 1 u għandu jitwaqqaf b'mod permanenti għal nefrite ta' Grad 4.
English: Renal cell carcinoma
Maltese: Karċinoma Metastatika taċ-Ċelluli Renali (IMDC - International Metastatic Renal Cell Carcinoma
English: Hyperglycaemia
Maltese: Immunoglobulini
English: 10 mL of concentrate in a vial (Type I glass) with a halobutyl rubber stopper and an aluminium seal fitted with a removable plastic cap.
Maltese: 10 mL ta' konċentrat f'kunjett (ħġieġ ta' Tip I) b'tapp tal-lastku tal-halobutyl u siġill tal-aluminju mgħammar b'għatu tal-plastik li jista' jitneħħa.
English: Patients with the following conditions were excluded from clinical trials: active central nervous system (CNS) metastasis; active or a history of autoimmune disease; a history of other malignancies within the last 5 years; organ transplant; conditions requiring therapeutic immune suppression or active infection with HIV, or hepatitis B or C.
Maltese: Pazjenti esklużi minn studji kliniċi Pazjenti bil-kundizzjonijiet li ġejjin ġew esklużi mill-provi kliniċi: metastasi attiva fis-sistema nervuża ċentrali (CNS - central nervous system); mard awtoimmuni attiv jew fil-passat; passat ta' tumuri malinni oħra fl-aħħar 5 snin; trapjant ta' organu; kundizzjonijiet li jeħtieġu soppressjoni immuni terapewtika jew infezzjoni attiva bl-HIV, jew epatite B jew Ċ.
English: Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4.
Maltese: Linji gwida dettaljati għall-immaniġġjar ta' reazzjonijiet avversi relatati mal-immunità huma deskritti f'sezzjoni 4.4.
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related nephritis.
Maltese: Minn dawn il-pazjenti, kien hemm 2 pazjenti (0.4%) b'nefrite relatata malimmunità ta' Grad 3.
English: • withhold the next dose of Bavencio,
Maltese: • ma jagħtikx id-doża li jmiss ta' Bavencio,
English: Adrenal insufficiency resolved in 4 (44.4%) of the 9 patients at the time of data cut-off.
Maltese: Insuffiċjenza adrenali fieqet f'4 (44.4%)
English: The safety of avelumab in combination with axitinib has been evaluated in 489 patients with advanced RCC receiving 10 mg/kg avelumab every 2 weeks and axitinib 5 mg orally twice daily in two clinical studies.
Maltese: Sommarju tal-profil tas-sigurtà Is-sigurtà ta' avelumab flimkien ma' axitinib ġiet evalwata f'489 pazjent b'RCC avvanzata li kienu qed jirċievu 10 mg/kg ta' avelumab kull ġimagħtejn u axitinib 5 mg mill-ħalq darbtejn kuljum f'żewġ studji kliniċi.
English: Based on data available, including the low incidence of immunogenicity, the impact of ADA on pharmacokinetics, efficacy and safety is uncertain, while the impact of neutralizing antibodies (nAb) is unknown.
Maltese: Ibbażat fuq dejta disponibbli, inkluża inċidenza baxxa ta' immunoġeniċità, l-impatt ta' ADA fuq il-farmakokinetika, l-effikaċja u s-sigurtà mhux ċert, waqt li l-impatt ta' antikorpi newtralizzanti (nAb - neutralizing antibodies) mhux magħruf.
English: This is very common.
Maltese: Dan iseħħ bi frekwenza mhux komuni.
English: Assessment of tumour status was performed at baseline, after randomisation at 6 weeks, then every 6 weeks thereafter up to 18 months after randomisation, and every 12 weeks thereafter until documented confirmed disease progression by BICR.
Maltese: Stima Kaplan-Meier dan sa 18-il xahar wara r-randomisation, u kull 12-il ġimgħa wara dan sa progressjoni kkonfermata talmarda dokumentata minn BICR.
English: Corticosteroids should be administered for immune-related myocarditis (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper).
Maltese: Kortikosterojdi għandhom jingħataw għal mijokardite relatata mal-immunità (doża inizjali ta' 1 sa 2 mg/kg/jum ta' prednisone jew ekwivalenti, segwita minn tnaqqis bil-mod tal-kortikosterojdi).
English: • Dryness in the mouth
Maltese: • Okklużjoni tal-musrana
English: The recommended dose of Bavencio in combination with axitinib is 800 mg administered intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.
Maltese: Id-doża rakkomandata ta' Bavencio flimkien ma' axitinib hija ta' 800 mg mogħtija ġol-vini fuq perjodu ta' 60 minuta kull ġimagħtejn u axitinib 5 mg mill-ħalq li jittieħed darbtejn kuljum (12-il siegħa bogħod minn xulxin) mal-ikel jew fuq stonku vojt sal-progressjoni tal-marda jew tossiċità inaċċettabbli.
English: Infusion related reaction * Immune-related adverse reaction based on medical review § Reaction only observed from study EMR 100070-003 (Part B) after the data cut-off of the pooled analysis, hence frequency estimated
Maltese: Reazzjoni osservata biss mill-istudju EMR100070-003 (Parti B) wara li waqfet tinġabar id-data tal-analiżi globali, għalhekk il-frekwenza hija stmata
English: Fatigue has been reported following administration of avelumab (see section 4.8).
Maltese: Għeja kbira kienet irrappurtata wara l-għoti ta' avelumab (ara sezzjoni 4.8).
English: Bavencio contains less than 1 mmol sodium (23 mg) in each dose and therefore is essentially sodium-free.
Maltese: Bavencio għandu kontenut baxx ta' sodium Bavencio fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis sodium'.
English: Lymphopenia, eosinophilia
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Immune-related adrenal insufficiency did not lead to discontinuation of avelumab in any patient.
Maltese: Insuffiċjenza adrenali relatata mal-immunità ma wasslitx għat-twaqqif ta' avelumab fl-ebda pazjent.
English: Fatigue, chills, asthenia, pyrexia
Maltese: • Dardir, ippurgar maħlul, stitikezza, rimettar
English: • Bowel occlusion
Maltese: • Tħossok kiesaħ
English: Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related colitis.
Maltese: Avelumab twaqqaf f'0.5% (9/1,738) tal-pazjenti minħabba kolite relatata mal-immunità.
English: Analysis of progression-free survival (PFS) was based on 39 patients who received at least one dose of avelumab, with median PFS of 9.1 months (95% CI: 1.9, not estimable) and estimated 3-month PFS rate by Kaplan-Meier of 67% (95% CI: 48, 80).
Maltese: ma setax jiġi stmat) u rata stmata ta' PFS ta' 3 xhur skont Kaplan-Meier ta' 67% (CI ta' 95%: 48, 80).
English: Dysphonia, cough, dyspnoea
Maltese: Astenja, dehxa ta' bard, marda li tixbah lill-influwenza
English: Administer the solution for infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter as described in section 4.2.
Maltese: Agħti s-soluzzjoni għall-infużjoni permezz ta' filtru fil-pajp jew miżjud ta' 0.2 mikrometri, sterili, mhux piroġeniku, li jeħel b'mod baxx mal-proteini kif deskritt f'sezzjoni 4.2.
English: The elimination half-life (t½) at the recommended dose is 6.1 days based on the population PK analysis.
Maltese: Il-half-life (t½) tal-eliminazzjoni fid-doża rakkomandata hija ta' 6.1 ġranet ibbażata fuq l-analiżi tal-PK
English: • Flu-like illness (includes feeling of fever, muscle aches)
Maltese: • Marda li tixbah lill-influwenza (li tinkludi sensazzjoni ta' deni, uġigħ fil-muskoli)
English: Infusion-related reactions Grade 1 infusion-related reaction
Maltese: Reazzjoni relatata mal-infużjoni ta' Grad 1
English: Autoimmune hepatitis*, acute hepatic failure*, hepatic failure*, hepatitis*
Maltese: pemphigoid*, ħakk ġeneralizzat*, ekżema, dermatite
English: Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related hepatitis.
Maltese: Avelumab twaqqaf f'0.5% (9/1,738) tal-pazjenti minħabba epatite relatata mal-immunità.
English: Rash, pruritus
Maltese: Kunjett wieħed
English: Immune-related hepatitis
Maltese: Epatite relatata mal-immunità
English: Grade 3 or Grade 4 endocrinopathies Withhold until adverse reactions recover to
Maltese: Endokrinopatiji ta' Grad 3 jew Grad 4 Waqqaf sakemm irreazzjonijiet avversi jirkupraw għal Grad 0-1
English: Nephritis and renal dysfunction
Maltese: Nefrite relatata mal-immunità u disfunzjoni tal-kliewi
English: In clinical trials, 98.6% (433/439) of patients with infusion-related reactions had a first infusion-related reaction during the first 4 infusions of which 2.7% (12/439) were Grade ≥ 3.
Maltese: Fil-provi kliniċi, 98.6% (433/439) tal-pazjenti b'reazzjonijiet relatati mal-infużjoni kellhom l-ewwel reazzjoni relatata mal-infużjoni waqt l-ewwel 4 infużjonijiet li minnhom 2.7% (12/439) kienu ta' Grad ≥ 3. Fil-1.4% (6/439) tal-pazjenti li kien fadal, reazzjonijiet relatati mal-infużjoni seħħew wara l-ewwel 4 infużjonijiet u kollha kienu ta' Grad 1 jew Grad 2.
English: Withhold until adverse reactions recover to Grade 0-1; restart infusion with a 50% slower rate
Maltese: Waqqaf sakemm irreazzjonijiet avversi jirkupraw għal Grad 0-1; ibda l-infużjoni mill-ġdid b'rata ta' 50% aktar baxxa.
English: Adverse reactions reported for 88 patients with metastatic MCC and for 1,650 patients in a phase I study in solid tumours are presented in Table 2.
Maltese: Lista ta' reazzjonijiet avversi f'tabella Reazzjonijiet avversi rrappurtati għal 88 pazjent b'MCC metastatika u għal 1,650 pazjent fi studju ta'
English: Based on a population PK analysis for avelumab as monotherapy and in combination with axitinib, there are no expected clinically meaningful differences in exposure of avelumab between settings administered every 2 weeks at 800 mg or 10 mg/kg.
Maltese: Ibbażat fuq analiżi tal-PK tal-popolazzjoni għal avelumab bħala monoterapija u flimkien ma' axitinib, mhux mistenija differenzi klinikament sinifikanti fl-esponiment għal avelumab bejn issettjar ta' għoti kull ġimagħtejn ta' 800 mg jew 10 mg/kg.
English: Patients excluded from clinical studies
Maltese: Komuni ħafna Tnaqqis fil-piż
English: • Headache, dizziness
Maltese: • Sogħla, qtugħ ta' nifs
English: Median PFS, months (95% CI) 3-month PFS rate by K-M, (95% CI) 6-month PFS rate by K-M, (95% CI) 12-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 * Efficacy data with a minimum follow-up of 7 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: K-M: Kaplan-Meier * Data tal-effikaċja b'segwitu minimu ta' 7 xhur (data meta waqfet tinġabar id-data 14 ta' Settembru 2018) ** CR jew PR kien ikkonfermat f'valutazzjoni sussegwenti tat-tumur a Ibbażat fuq numru ta' individwi b'rispons ikkonfermat (CR jew PR) Figura 2 tippreżenta l-kurva Kaplan-Meier għal PFS mill-analiżi interim sussegwenti b'116-il pazjent irreġistrati fil-Parti B b'segwitu minimu ta' 7 xhur.
English: Initiate treatment with insulin for Type 1 diabetes mellitus.
Maltese: Ibda trattament bl-insulina għal dijabete mellitus ta' Tip 1.
English: The clinical utility of PD-L1 as a predictive biomarker in MCC has not been established.
Maltese: L-utilità klinika ta' PD-L1 bħala bijomarkatur ta' tbassir f'MCC għadha ma ġietx stabbilita.
English: AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
Maltese: AST jew ALT akbar minn 5 darbiet talULN jew bilirubina totali akbar minn 3 darbiet l-ULN
English: Immune-related pancreatitis has been reported in patients receiving avelumab.
Maltese: Pulmonite relatata mal-immunità ma wasslitx għat-twaqqif ta' avelumab fl-ebda pazjent.
English: • Signs of liver problems, including inflammation of the liver (hepatitis) may include yellowing of your skin (jaundice) or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual, tiredness or abnormal liver function tests.
Maltese: • Sinjali ta' problemi fil-fwied, inklużi infjammazzjoni tal-fwied (epatite) jistgħu jinkludu sfurija tal-ġilda tiegħek (suffejra) jew tal-abjad ta' għajnejk, dardir sever jew rimettar, uġigħ finnaħa tal-lemin taż-żona tal-istonku tiegħek (addome), ngħas, awrina skura (kulur it-tè), ħruġ ta' demm jew titbenġel aktar malajr mis-soltu, tħossok inqas bil-ġuħ mis-soltu, għeja jew testijiet tal-funzjoni tal-fwied ma jkunux normali.
English: For at least the first 4 treatments, you will receive paracetamol and an antihistamine before being given Bavencio, to help to prevent possible side effects related to the infusion.
Maltese: Għal mill-inqas l-ewwel 4 trattamenti, inti se tirċievi paracetamol u mediċina antistamina qabel tingħata Bavencio, biex jgħinu jevitaw effetti sekondarji possibbli relatati mal-infużjoni.
English: Of these patients, there were 3 (0.2%) patients with Grade 3 immune-related thyroid disorders.
Maltese: Minn dawn ilpazjenti kien hemm 3 (0.2%) pazjenti b'disturbi tat-tirojde relatati mal-immunità ta' Grad 3.
English: 12-month PFS rate by K-M, (95% CI)** 52.4% (47.4, 57.2) 18-month PFS rate by K-M, (95% CI)** 43.9% (38.8, 49.0)
Maltese: (N=444, Avvenimenti=258, Medjan=8.0 xhur, CI ta' 95% (6.7, 9.8))
English: Immune-related hepatitis resolved in 9 (56%) of the 16 patients at the time of data cut-off.
Maltese: Epatite relatata mal-immunità fieqet f'9 (56%) minn 16-il pazjent fiż-żmien meta waqfet tinġabar id-dejta.
English: Steady-state concentrations of avelumab were reached after approximately 4 to 6 weeks (2 to 3 cycles) of repeated dosing at 10 mg/kg every 2 weeks, and systemic accumulation was approximately 1.25-fold.
Maltese: dożaġġ ripetut ta' 10 mg/kg kull ġimagħtejn, u l-akkumulazzjoni sistemika kienet madwar 1.25 darbiet.
English: Table 6: Subsequent interim analysis of response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part B)*
Maltese: Analiżi interim sussegwenti tar-rispons għal avelumab 10 mg/kg kull ġimagħtejn f'pazjenti b'MCC metastatika fl-istudju EMR100070-003 (Parti B)* Punti finali tal-effikaċja (Parti B) (skont RECIST v1.1, IERC)
English: If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, both Bavencio and axitinib should be permanently discontinued and corticosteroid therapy should be considered.
Maltese: Jekk l-ALT jew l-AST ikunu ≥ 5 darbiet l-ULN jew > 3 darbiet l-ULN flimkien ma' bilirubina totali ta' ≥ 2 darbiet l-ULN jew bilirubina totali ≥ 3 darbiet l-ULN, kemm Bavencio kif ukoll axitinib għandhom jitwaqqfu b'mod permanenti u għandha tiġi kkunsidrata terapija b'kortikosterojdi.
English: Many of the male monkeys used in these studies were sexually immature and thus no explicit conclusions regarding effects on male reproductive organs can be made.
Maltese: Ħafna mixxadini rġiel użati f'dawn l-istudji kienu sesswalment immaturi u għalhekk ma jistgħux isiru konklużjonijiet espliċiti dwar l-effetti fuq organi riproduttivi maskili.
English: Name and address of the manufacturer(s) responsible for batch release
Maltese: U MANIFATTUR(I) RESPONSABBLI GĦALL
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose 1 to 2 mg/kg/day prednisone or equivalent, followed by a corticosteroid taper).
Maltese: Kortikosterojdi għandhom jingħataw għal avvenimenti ta' Grad ≥ 2 (doża inizjali ta' 1 sa 2 mg/kg/jum ta' prednisone jew ekwivalenti, segwit minn tnaqqis bil-mod tal-kortikosterojdi).
English: Avelumab was discontinued in 0.2% (1/489) of patients due to immune-related thyroid disorders.
Maltese: Avelumab twaqqaf f'0.2% (1/489) tal-pazjenti minħabba disturbi tat-tirojde relatati mal-immunità.
English: Other immune-related adverse reactions (including myositis, hypopituitarism, uveitis, Guillain-Barré syndrome)
Maltese: ipopitwitariżmu, uveite, sindrome ta' GuillainBarré)
English: Figure 2 presents the Kaplan-Meier curve for PFS from the subsequent interim analysis with 116 patients enrolled into Part B with a minimum follow-up of 7 months.
Maltese: Wara li l-Parti B kienet irreġistrata kompletament, analiżi interim sussegwenti twettqet b'116
English: Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related thyroid disorders.
Maltese: Avelumab twaqqaf f'0.1% (2/1,738) tal-pazjenti minħabba disturbi tat-tirojde relatati mal-immunità.
English: Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
Maltese: Wara li jinfetaħ Mill-aspett mikrobijoloġiku, ladarba jinfetaħ, il-prodott mediċinali għandu jiġi dilwit u infuż immedjatament.
English: In patients treated with avelumab in combination with axitinib, Type 1 diabetes mellitus without an alternative aetiology occurred in 1.0% (5/489) of patients.
Maltese: F'pazjenti ttrattati b'avelumab flimkien ma' axitinib, dijabete mellitus tat-Tip 1 mingħajr etjoloġija alternattiva seħħet f'1.0% (5/489) tal-pazjenti.
English: The median time to onset of immune-related colitis was 5.1 months (range: 2.3 weeks to 14 months).
Maltese: Iż-żmien medjan għall-bidu ta' kolite relatata mal-immunità kien ta' 5.1 xhur (medda: 2.3 ġimgħat sa 14-il xahar).
English: Twenty-two out of 29 (76%) patients with response were reported to have responded within 7 weeks after the first dose of avelumab.
Maltese: Tnejn u għoxrin minn 29 (76%) pazjent b'rispons kienu rrappurtati li rrispondew fi żmien 7 ġimgħat wara l-ewwel doża ta' avelumab.
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related thyroid disorders.
Maltese: Minn dawn il-pazjenti, kien hemm 2 pazjenti (0.4%) b'disturbi tat-tirojde relatati mal-immunità ta' Grad 3.
English: Thyroid disorders resolved in 7 (7%) of the 98 patients at the time of data cut-off.
Maltese: Disturbi tat-tirojde fiequ f'7 (7%) minn 98 pazjent fiż-żmien meta waqfet tinġabar id-dejta.
English: The median duration was not estimable (range: 8 days to more than 23.9 months).
Maltese: It-tul medjan ma setax jiġi stmat (medda: 8 ijiem sa aktar minn 23.9 xhur).
English: Patients were included irrespective of prognostic risk groups or tumour PD-L1 expression and had to have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 that was not been previously irradiated.
Maltese: Il-pazjenti kienu inklużi irrispettivament mill-gruppi ta' riskju pronostiku jew mill-espressjoni ta' PD-L1 tat-tumur u ried ikollhom tal-anqas leżjoni waħda li tista' titkejjel kif definit mill-Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST - Response Evaluation Criteria in Solid Tumours)
English: In case of recurrence of Grade 1 or Grade 2 infusion-related reaction, the patient may continue to receive avelumab under close monitoring, after appropriate infusion rate modification and premedication with paracetamol and antihistamine (see section 4.2).
Maltese: F'każ ta' rikorrenza ta' reazzjoni relatata mal-infużjoni ta' Grad 1 jew Grad 2, il-pazjent jista' jkompli jirċievi avelumab b'monitoraġġ mill-qrib, wara modifikazzjoni xierqa tar-rata tal-infużjoni u medikazzjoni minn qabel b'paracetamol u mediċina antistamina (ara sezzjoni 4.2).
English: Avelumab should be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for Grade 4 immune-related adverse reaction (see section 4.2).
Maltese: Avelumab għandu jitwaqqaf b'mod permanenti għal kwalunkwe reazzjoni avversa relatata mal-immunità ta' Grad 3 li sseħħ mill-ġdid u għal reazzjoni avversa relatata mal-immunità ta' Grad 4 (ara sezzjoni 4.2).
English: All 26 patients with immune-related colitis were treated with corticosteroids and 15 (58%) of the 26 patients received high-dose corticosteroids for a median of 19 days (range: 1 day to 2.3 months).
Maltese: Is-26 pazjenti kollha b'kolite relatata mal-immunità kienu ttrattati b'kortikosterojdi u 15 (58%) mis-26 pazjent irċevew doża għolja ta' kortikosterojdi għal medjan ta' 19-il ġurnata (medda: ġurnata sa 2.3 xhur).
English: Fertility The effect of avelumab on male and female fertility is unknown.
Maltese: L-effett ta' avelumab fuq il-fertilità maskili u femminili mhux magħruf.
English: All 13 patients with immune-related colitis were treated with corticosteroids and 12 (92.3%) of the 13 patients received high-dose corticosteroids for a median of 2.3 weeks (range: 5 days to 4.6 months).
Maltese: It-13-il pazjent kollha b'kolite relatata mal-immunità kienu ttrattati b'kortikosterojdi u 12 (92.3%) mit-13-il pazjent irċevew kortikosterojdi ta' doża għolja għal medjan ta' 2.3 ġimgħat (medda: 5 ijiem sa 4.6 xhur).
English: Thyroid disorders
Maltese: Disturbi tat-tirojde
English: Hepatic function abnormal
Maltese: Komuni ħafna Anemija
English: • inflammation of your intestines (colitis), diarrhoea (watery, loose or soft stools) or more bowel movements than usual;
Maltese: • Sinjali ta' infjammazzjoni tal-qalb (mijokardite) jistgħu jinkludu diffikultà biex tieħu n-nifs,
English: Hepatic impairment
Maltese: Individwi kollha
English: Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of Bavencio.
Maltese: Il-pazjenti għandhom jingħataw mediċina antistamina u paracetamol qabel l-ewwel 4 infużjonijiet ta' Bavencio.
English: For Grade 3 or Grade 4 infusion-related reactions, the infusion should be stopped and avelumab should be permanently discontinued (see section 4.2).
Maltese: Għal reazzjonijiet relatati mal-infużjoni ta' Grad 3 jew Grad 4, l-infużjoni għandha titwaqqaf u avelumab għandu jitwaqqaf b'mod permanenti (ara sezzjoni 4.2).
English: Bavencio binds to PD-L1, and blocks this protective effect, allowing the immune system to attack the tumour cells.
Maltese: Bavencio jingħaqad ma' PD-L1, u jimblokka dan l-effett protettiv, u jħalli s-sistema immuni tattakka liċ-ċelluli tat-tumur.
English: Dry mouth, colitis
Maltese: Ħalq xott, kolite
English: Administer the infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or addon filter.
Maltese: Agħti l-infużjoni permezz ta' filtru fil-pajp jew miżjud ta' 0.2 mikrometri, sterili, mhux piroġeniku, li jeħel b'mod baxx mal-proteini.